System Manual

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ, 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2005 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714336-01D Rev. Date: 01/25/05

Patents
CA 1,281,072; CA 1,303,175; CA 1,330,888; CA 2,002,848; CA 2,087,720; CA 2,087,966;
CA 2,175,228; CA 2,193,000; CA 2,194,795; CA 2,221,178; EP 0408575; EP 0412119; EP 0434742;
EP 0442969; EP 0505169; EP 0540691; EP 0543916; JP 2113412; JP 2521826; JP 2833809; JP
2948321; JP 3093274; JP 3105919; JP 3105922; JP 3137612; JP 3269553; JP 3392871; US 4,864,229;
US 4,933,048; US 4,954,087; US 5,008,616; US 5,096,669; US 5,112,455; US 5,121,050; US
5,124,661; US 5,200,051; US 5,447,440; US 5,466,575; US 5,514,253; US 5,554,339; US 5,605,664;
US 5,609,824; US 5,614,416; US 5,628,961; US 5,789,253; US 5,821,399; US 5,837,446; US
6,030,827; US 6,379,883; US 6,438,498; US 6,750,053; US D332,833; US D337,164

Symbol Technologies Corporation is the owner of US Patent Nos. 4,758,717; 5,130,520; 5,262,628;
5,396,055; 5,532,469.

Trademarks
i-STAT is a registered trademark of i-STAT Corporation. MediSense is a registered trademark
of Abbott Laboratories. Precision and PCx are trademarks of Abbott Laboratories. Windows is a
registered trademark of Microsoft Corporation.

Art: 714336-01D Rev. Date: 01/25/05

 i-STAT 1 SYSTEM MANUAL CONFIGURATION

Please ensure that the contents of your System Manual are complete and up to date. In the event that your System
Manual does not contain the current configuration, it is recommended that you contact your i-STAT support provider.
®
As of April 2005, your i-STAT 1 System Manual should be configured with the contents as listed below and in the
order shown.
ITEM Art #
Cover Sheet ..................................................................................... 714336-01D
Configuration Sheet .......................................................................... 714419-01P
Table of Contents.............................................................................. 714362-01E
Section 1 ........................................................................................... 714363-01D
Section 2 ........................................................................................... 714364-01D
Section 3 ........................................................................................... 714365-01C
Section 4 ........................................................................................... 714366-01B
Section 5 ........................................................................................... 714367-01B
Section 6 ........................................................................................... 714368-01D
Section 7 ........................................................................................... 714369-01C
Section 8 ........................................................................................... 714370-01C
Section 9 ........................................................................................... 714371-01C
Section 10 ......................................................................................... 714372-01C
Section 11 ......................................................................................... 714373-01C
Section 12 ......................................................................................... 714374-01C
Section 13 ......................................................................................... 714375-01B
Section 14 ......................................................................................... 714376-01C
Section 15 ......................................................................................... 714377-01D
Section 16 ......................................................................................... 714378-01B
Section 17 ......................................................................................... 714379-01D
Section 18 ......................................................................................... 714380-01C
Section 19 ......................................................................................... 714381-01C
Section 20 ......................................................................................... 714382-01B
Section 21 ......................................................................................... 714383-01C
Section 22 ......................................................................................... 714384-01C

CTI Sheets
Introduction ....................................................................................... 714258-01F
Sodium.............................................................................................. 714173-01F
Potassium ......................................................................................... 714174-01E
Chloride............................................................................................. 714175-01F
Urea Nitrogen/BUN ........................................................................... 714176-01E
Glucose............................................................................................. 714177-01E
Hematocrit/Hemoglobin..................................................................... 714178-01F
Ionized Calcium................................................................................. 714179-01F
PO2 / sO2 .......................................................................................... 714180-01E
pH ..................................................................................................... 714181-01F
PCO2/HCO3/TCO2/BE/AG................................................................. 714182-01H
Creatinine.......................................................................................... 714183-01G
Lactate .............................................................................................. 714184-01D
Celite ACT......................................................................................... 714185-01D
Prothrombin Time PT/INR................................................................. 715236-01C
Kaolin ACT ........................................................................................ 715878-01C
Cardiac Troponin I............................................................................. 715595-01C

Technical Bulletin
Analyzer Coded Messages ............................................................... 714260-01C
K2EDTA and K3EDTA Customization for
Hematocrit on the i-STAT System..................................................... 716240-01A
Installation Guide for the Central Data Station to
Receive Data from a Philips Clinical Data Server ............................. 714270-01A
ACT Test Result Options: Prewarmed vs. Non-Prewarmed
Result Calibration Modes for the i-STAT 1 Analyzer ......................... 715617-01B
Art.: 714419-01P Rev. Date: 03/01/05
October 2004 Update to the
i-STAT Central Data Station Version 5.............................................. 716134-01A
April 2005 Update to the
i-STAT Central Data Station Version 5.............................................. 716244-01A
Support Services............................................................................... 716144-01B

Art.: 714419-01P Rev. Date: 03/01/05

 Contents
INTRODUCTION ..................................................................................................... 1 - 1
This Manual.......................................................................................................................................... 1 - 1
Intended Use ........................................................................................................................................ 1 - 1
Overview of the i-STAT System ............................................................................................................ 1 - 1
Components ......................................................................................................................................... 1 - 2
Selection of Components ..................................................................................................................... 1 - 2
Summary of the Procedure .................................................................................................................. 1 - 2
Data Management................................................................................................................................ 1 - 3
Interfacing ............................................................................................................................................ 1 - 3
Note Regarding System Reliability....................................................................................................... 1 - 3
Symbols ............................................................................................................................................... 1 - 3
Warranty ............................................................................................................................................... 1 - 7

SYSTEM COMPONENTS

i-STAT 1 ANALYZER .............................................................................................. 2 - 1

Introduction .......................................................................................................................................... 2 - 1
Before You Use the Analyzer ................................................................................................................ 2 - 1
Specifications ....................................................................................................................................... 2 - 2
Software ............................................................................................................................................... 2 - 3
Power ................................................................................................................................................... 2 - 3
Disposable Batteries ............................................................................................................................ 2 - 3
Rechargeable Battery .......................................................................................................................... 2 - 3
Low Battery Warning ............................................................................................................................ 2 - 3
Cartridge Port....................................................................................................................................... 2 - 4
Test Strip Port....................................................................................................................................... 2 - 4
Infrared Communication Window ......................................................................................................... 2 - 5
Thermal Control ................................................................................................................................... 2 - 5
Barometric Pressure Sensor ................................................................................................................ 2 - 5
Cartridge Test Cycle ............................................................................................................................. 2 - 5
Strip Test Cycle .................................................................................................................................... 2 - 5
Data Entry ............................................................................................................................................ 2 - 6
Storage of Results................................................................................................................................ 2 - 6
LCD Display and Backlight ................................................................................................................... 2 - 7
Audible Indicator................................................................................................................................... 2 - 7
Time Out .............................................................................................................................................. 2 - 7
Keypad ................................................................................................................................................. 2 - 8
i-STAT 1 Menu Tree .............................................................................................................................. 2 - 9
Test Menu............................................................................................................................................. 2 - 10
Administration Menu ............................................................................................................................ 2 - 10
Analyzer Status .................................................................................................................................... 2 - 11
Data Review ......................................................................................................................................... 2 - 11
Quality Tests ......................................................................................................................................... 2 - 12
Customization ..................................................................................................................................... 2 - 13
Set Clock .............................................................................................................................................. 2 - 17
Transmit Data ....................................................................................................................................... 2 - 17
Utility .................................................................................................................................................... 2 - 17
Laser Barcode Scanner ....................................................................................................................... 2 - 18
Prompts and Messages ....................................................................................................................... 2 - 19

Art: 714362-01E Rev. Date: 07/12/04 i

i-STAT CARTRIDGE ............................................................................................... 3 - 1
Contents ............................................................................................................................................... 3 - 1
Standardization and Calibration ........................................................................................................... 3 - 3
Packaging............................................................................................................................................. 3 - 3
Storage Conditions............................................................................................................................... 3 - 4
Disposal ............................................................................................................................................... 3 - 4

PRECISION PCx AND PCx PLUS BLOOD GLUCOSE TEST STRIPS ................. 4 - 1

ELECTRONIC SIMULATOR ................................................................................... 5 - 1

Internal Simulator ................................................................................................................................. 5 - 1
External Simulator ................................................................................................................................ 5 - 1
Operating Characteristics..................................................................................................................... 5 - 2
Cleaning the Simulator ......................................................................................................................... 5 - 2

i-STAT 1 DOWNLOADER ....................................................................................... 6 - 1

Function ............................................................................................................................................... 6 - 1
Specifications ....................................................................................................................................... 6 - 2
Power Supply ....................................................................................................................................... 6 - 2
Downloader/Recharger Indicator LEDs................................................................................................ 6 - 3
Power Requirements ............................................................................................................................ 6 - 3
Cautions ............................................................................................................................................... 6 - 3
Transmitting Data from Downloader to the Data Manager ................................................................... 6 - 4
Transmitting Data from Downloader/Recharger to the Data Manager ................................................. 6 - 4
Transmitted Information ........................................................................................................................ 6 - 4
Troubleshooting .................................................................................................................................... 6 - 5
Charging the Rechargeable Battery ..................................................................................................... 6 - 5
Charging Rechareable Battery in the External Recharge Compartment ............................................. 6 - 6

PORTABLE PRINTER ............................................................................................ 7 - 1

MARTEL Printer ......................................................................................................................................... 7 - 1

Overview .............................................................................................................................................. 7 - 1
Specifications ....................................................................................................................................... 7 - 1
Supplies Provided with Printer ............................................................................................................. 7 - 2
Power ................................................................................................................................................... 7 - 2
Loading Paper ...................................................................................................................................... 7 - 2
Printing Directly from the Analyzer ....................................................................................................... 7 - 3
Printing Via a Downloader .................................................................................................................... 7 - 3
Printing Many Results .......................................................................................................................... 7 - 4
What is Printed ..................................................................................................................................... 7 - 4
Cautions ............................................................................................................................................... 7 - 4
Troubleshooting .................................................................................................................................... 7 - 5

DATA MANAGEMENT ............................................................................................ 8 - 1

Introduction .......................................................................................................................................... 8 - 1
Components ......................................................................................................................................... 8 - 1
Data Manager ...................................................................................................................................... 8 - 2
i-STAT Central Data Station Version 5 Software................................................................................... 8 - 2
Downloader and Downloader/Recharger ............................................................................................. 8 - 3
IR Link .................................................................................................................................................. 8 - 3
LIS/HIS Interface .................................................................................................................................. 8 - 3
Standard Data Management Configuration.......................................................................................... 8 - 4
Connecting Components...................................................................................................................... 8 - 4

CUSTOMIZATION ................................................................................................... 9 - 1

ii Art: 714362-01E Rev. Date: 07/12/04

 PROCEDURES

SAMPLE COLLECTION ......................................................................................... 10 - 1

Specimen Collection ............................................................................................................................ 10 - 1
Venipuncture - General ........................................................................................................................ 10 - 1
Venipuncture - pH, PCO2, Electrolyte, Chemistry, and Hematocrit Tests ........................................... 10 - 2
Venipuncture - Coagulation Tests ......................................................................................................... 10 - 3
Venipuncture - Glucose Test Strip ........................................................................................................ 10 - 4
Arterial Puncture - General .................................................................................................................. 10 - 4
Arterial Puncture - Blood Gas, Electrolyte, Chemistry, and Hematocrit Tests ..................................... 10 - 4
Arterial Puncture - Coagulation Tests.................................................................................................. 10 - 5
Arterial Puncture - Glucose Test Strips ............................................................................................... 10 - 5
Indwelling Line ..................................................................................................................................... 10 - 6
Skin Puncture ....................................................................................................................................... 10 - 6
Sample Transfer Devices...................................................................................................................... 10 - 7
References ........................................................................................................................................... 10 - 8

PROCEDURE FOR HANDLING CARTRIDGES .................................................... 11 - 1

Preparation for Testing ......................................................................................................................... 11 - 1
Filling and Sealing Cartridge Using Transfer Device ............................................................................ 11 - 2
Filling and Sealing PT/INR Cartridges Using Direct Fingerstick Sampling .......................................... 11 - 2
Filling and Closing a cTnI Cartridge Using Transfer Device ................................................................. 11 - 3
Inserting and Removing the Cartridge From the Analyzer ................................................................... 11 - 4
Incorrect Procedure.............................................................................................................................. 11 - 5

PROCEDURE FOR CARTRIDGE TESTING .......................................................... 12 - 1

Cautions ............................................................................................................................................... 12 - 1
Performing Patient Analysis with Cartridge – Information First Disabled ............................................. 12 - 2
Performing Patient Analysis with Cartridge – Information First Enabled .............................................. 12 - 4
Interpretation of Displayed Results ..................................................................................................... 12 - 7
Troubleshooting .................................................................................................................................... 12 - 9

PROCEDURES FOR GLUCOSE TEST STRIP TESTING ..................................... 13 - 1

Operating Guidelines for All Samples .................................................................................................. 13 - 1
Performing Patient Glucose Assay with Test Strip................................................................................ 13 - 2
Caution ................................................................................................................................................. 13 - 4
Interpretation of Displayed Results ...................................................................................................... 13 - 5
Troubleshooting .................................................................................................................................... 13 - 6

QUALITY CONTROL .............................................................................................. 14 - 1

Overview ............................................................................................................................................. 14 - 1
Quality Control for i-STAT Cartridges and the Analyzer’s Cartridge Test Cycle ................................... 14 - 1
Controls for Blood Gas/Electrolyte/Metabolite Cartridges .................................................................... 14 - 3
Correction of PO2 at Extreme Altitude ................................................................................................. 14 - 5
Controls for Hematocrit Sensor ............................................................................................................ 14 - 6
Controls for ACT Cartridges ................................................................................................................. 14 - 6
Controls for PT/INR Cartridges ............................................................................................................ 14 - 8
Controls for cTnI Cartridges ................................................................................................................. 14 - 9
Performing Electronic Simulator Test ................................................................................................... 14 - 10
Procedure for Internal Electronic Simulator ......................................................................................... 14 - 10
Procedure for External Electronic Simulator ........................................................................................ 14 - 11
Troubleshooting Failed Electronic Simulator Test ................................................................................. 14 - 12
Checking the Thermal Probes in the i-STAT Analyzers ........................................................................ 14 - 13
Procedure to Check Ambient Temperature .......................................................................................... 14 - 15
Performing Control Test on Cartridge ................................................................................................... 14 - 15
Troubleshooting Out-of-Range Control Results on Cartridge .............................................................. 14 - 17
Controls for Glucose Test Strip............................................................................................................. 14 - 17

Art: 714362-01E Rev. Date: 07/12/04 iii

 Recommendations for Glucose Test Strips .......................................................................................... 14 - 18
Performing Control Test with Glucose Strip .......................................................................................... 14 - 18
Troubleshooting Out-of-Range Results on Test Strips ......................................................................... 14 - 20
Quality Control Log Sheets .................................................................................................................. 14 - 21

CALIBRATION VERIFICATION .............................................................................. 15 - 1

Calibration Verification for Blood Gas/Electrolyte/Metabolite Cartridges.............................................. 15 - 1
i-STAT Calibration Verification Set ........................................................................................................ 15 - 2
i-STAT Cardiac Marker Calibration Verification Set .............................................................................. 15 - 4
Verification Procedure for Hematocrit .................................................................................................. 15 - 5
Verification Procedure for ACT ............................................................................................................. 15 - 6
Procedure for Cartridges ...................................................................................................................... 15 - 7
Troubleshooting Cartridge Tests ........................................................................................................... 15 - 8
Linearity/Calibration Verification Test for Test Strips ............................................................................. 15 - 9
Troubleshooting Strip Tests .................................................................................................................. 15 - 10

PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING ........................... 16 - 1

Purpose ................................................................................................................................................ 16 - 1
General Procedure ............................................................................................................................... 16 - 1
Procedure For Cartridges .................................................................................................................... 16 - 1
Troubleshooting .................................................................................................................................... 16 - 3
Procedure for Test Strips ...................................................................................................................... 16 - 4

CARE AND SOFTWARE UPDATES

ROUTINE CARE of the ANALYZER and DOWNLOADER .................................... 17 - 1

Drying a Wet Analyzer or Downloader ................................................................................................ 17 - 1
Cleaning the Analyzer and Downloader ............................................................................................... 17 - 1
Removing and Replacing Disposable Batteries ................................................................................... 17 - 2
Removing and Replacing the Rechargeable Battery ........................................................................... 17 - 3

UPDATING THE SOFTWARE ................................................................................. 18 - 1

CLEW .................................................................................................................................................. 18 - 1
Application Software ............................................................................................................................ 18 - 1
Software Updates................................................................................................................................. 18 - 1
Updating Analyzer Software: JAMMLITE Utility ................................................................................... 18 - 2
Troubleshooting .................................................................................................................................... 18 - 8
Analyzer-to-Analyzer Software Updates .............................................................................................. 18 - 9

TROUBLESHOOTING THE ANALYZER

TROUBLESHOOTING THE ANALYZER ................................................................ 19 - 1

Introduction .......................................................................................................................................... 19 - 1
Information Needed.............................................................................................................................. 19 - 1
Startup Messages ................................................................................................................................ 19 - 2
Test Cycle Messages and Quality Check Codes ................................................................................. 19 - 3
Glucose Strip Errors ............................................................................................................................. 19 - 6
No Display ............................................................................................................................................ 19 - 7
“Cartridge Locked” Not Removed......................................................................................................... 19 - 7

iv Art: 714362-01E Rev. Date: 07/12/04

 THEORY

THEORY .................................................................................................................. 20 - 1
Analyzer Functions............................................................................................................................... 20 - 1
Electrochemical Measurements ........................................................................................................... 20 - 3
Determination of Test Results .............................................................................................................. 20 - 4
Determination of Cell Concentration .................................................................................................... 20 - 5
CPB ...................................................................................................................................................... 20 - 5
Determination of Coagulation Endpoints ............................................................................................. 20 - 7
Quality Control and the i-STAT System ................................................................................................ 20 - 7
Quality Control and the i-STAT Coagulation Tests ................................................................................ 20 - 12

DOWNLOADER PROGRAMMING

DOWNLOADER PROGRAMMING AND WIRING .................................................. 21 - 1

Programming the Network Downloaders ............................................................................................. 21 - 1
Wiring the Downloaders ....................................................................................................................... 21 - 6

CENTRAL DATA STATION

CENTRAL DATA STATION ..................................................................................... 22 - 1

i-STAT License Agreement and Warranty for Central Data Station Program ....................................... 22 - 1
Installation Of The Central Data Station ............................................................................................... 22 - 3
General Procedures and Conventions ................................................................................................. 22 - 5
Customization of the Central Data Station ........................................................................................... 22 - 9
Interface Program Customization ......................................................................................................... 22 - 15
Overview of the Central Data Station Program .................................................................................... 22 - 17
Administration Tools ............................................................................................................................. 22 - 19
Instrument and Location Workspace .................................................................................................... 22 - 19
Operator Workspace ............................................................................................................................ 22 - 25
Operator List Import ............................................................................................................................. 22 - 31
Database Maintenance ........................................................................................................................ 22 - 33
Inventory Workspace............................................................................................................................ 22 - 37
Customization Workspace.................................................................................................................... 22 - 43
User Administration Workspace ........................................................................................................... 22 - 51
Password Management ........................................................................................................................ 22 - 53
Data Viewers ........................................................................................................................................ 22 - 55
Monitors ............................................................................................................................................... 22 - 61
Reports ................................................................................................................................................ 22 - 63
System ................................................................................................................................................. 22 - 67
Language Support ............................................................................................................................... 22 - 69

Art: 714362-01E Rev. Date: 07/12/04 v

 CARTRIDGE AND TEST INFORMATION
Cartridge and Test Information
Sodium
Potassium
Chloride
BUN/Urea
Glucose
Hematocrit/Hemoglobin
Ionized Calcium
PO2
pH
PCO2
Creatinine
Lactate
Celite ACT
Prothrombin Time PT/INR
Cardiac Troponin I
Kaolin ACT

TECHNICAL BULLETINS

vi Art: 714362-01E Rev. Date: 07/12/04

 INTRODUCTION 1
This Manual This manual describes the i-STAT®1 Analyzer and the Central Data Station
software. Related sections are grouped behind tabs.

The i-STAT Portable Clinical Analyzer and the Philips Medical Systems Blood
Analysis Module (formerly supplied by Agilent Technologies, and Hewlett-
Packard, Inc., for the Viridia CMS Patient Monitors) are described in a separate
manual.

Intended Use The i-STAT 1 Analyzer is intended for use with i-STAT cartridges for in vitro
quantification of various analytes in whole blood and with the Abbott
MediSense® Precision PCx™ Blood Glucose Test Strip for the in vitro quantification
of glucose in whole blood. Analyzers, cartridges, and test strips should be used
by healthcare professionals trained and certified to use the system and should
be used according to the facility’s policies and procedures.

Overview of the The i-STAT System incorporates a comprehensive group of components needed
i-STAT System to perform blood analysis at the point of care. A portable handheld analyzer, a
cartridge with the required tests, and 2-3 drops of blood will allow the caregiver
to view quantitative test results for blood gas, chemistry and coagulation tests in
approximately two minutes. Glucose results are available from the Precision PCx
Blood Glucose Test Strip in as little as 20 seconds on the handheld analyzer.

Portable printers and infrared communication devices allow all patient

information obtained at the bedside to be printed on demand and transmitted
to centralized information systems for record keeping and billing.

The Central Data Station program provides system management tools including
real-time monitoring of testing and operator competency.

Art: 714363-01D Rev. Date: 01/25/05 1-1

Components The i-STAT System consists of:

 i-STAT Cartridges
 Abbott MediSense Precision PCx and PCx Plus Blood Glucose Test
Strips
 i-STAT 1 Analyzer
 i-STAT Portable Clinical Analyzer
 Philips Medical Systems Blood Analysis Module (used in conjunction
with a patient monitor)
 Portable Printer
 Quality Assurance Materials
• Electronic Simulator
• Control Solutions
• Calibration Verification Set (for cartridges)
• Linearity Assessment Kit (for test strips)
 Data Management System
• i-STAT 1 Downloader
• i-STAT 1 Downloader/Recharger
• IR Link for Portable Clinical Analyzer
• Data Manager
 Central Data Station (data management software for cartridges)
 QC Manager (data management software for test strips)
 Data Manager Printer
 LIS/HIS Interface Software
Selection of The selection of system components is dependent on factors unique to each
Components facility such as:

 Types of tests to be performed

 Number of testing sites
 Number of tests per site
 System administration requirements

Summary of the To perform cartridge testing, the operator fills a cartridge with sample, seals
Procedure the cartridge with its snap closure, and inserts the cartridge into the analyzer.
Inserting the cartridge activates the analyzer. Alternatively, the cartridge test cycle
can be initiated from the keypad/menu system. The unit-use cartridge contains
all components to perform one or more tests including: calibrating solution,
sample handling system, sensors and reagents. The analyzer automatically
controls all steps in the testing cycle, which may include: fluid movement,
reagent mixing, calibration and thermal control. Quality checks are performed
continuously throughout the test cycle. Operator and patient IDs and patient
chart information can be entered. When the test cycle is completed, results are
displayed and the test record is stored. To perform glucose test strip testing, the
operator selects a the glucose strip option from the menu, scans the test strip
barcode, inserts the test strip into the analyzer test strip port and applies sample
to the test strip. This degree of automation, along with the ability to test fresh
whole blood, eliminates many sources of error as well as time-consuming and
costly steps inherent in other methods.
1-2 Art: 714363-01D Rev. Date: 01/25/05
Data Management Test records can be transmitted to the Data Manager where they can be
printed and/or transmitted to the Laboratory Information System or Hospital
Information System. An optional portable printer enables the operator to print
results at the point of care.

Interfacing The Data Manager can be interfaced to a Laboratory Information System (LIS)
or Hospital Information System (HIS) to automate billing and patient record
keeping.

Note Regarding System Reliability

The i-STAT System automatically runs a comprehensive set of quality checks of analyzer and cartridge
performance each time a sample is tested. This internal quality system will suppress results if the analyzer
or cartridge does not meet certain internal specifications (see Quality Control section in System Manual
for detailed information). To minimize the probability of delivering a result with medically significant
error the internal specifications are very stringent. It is typical for the system to suppress a very small
percentage of results in normal operation given the stringency of these specifications. If however the
analyzer or cartridges have been compromised, results may be persistently suppressed, and one or the
other must be replaced to restore normal operating conditions. Where unavailability of results while
awaiting replacement of analyzers or cartridges is unacceptable, i-STAT recommends maintaining
both a backup i-STAT System analyzer and cartridges from an alternate lot number.

Symbols Symbols can be helpful in reducing the necessity for translating important
information into multiple languages, particularly where space is limited. The
following symbols may be found on components of the i-STAT System.

Symbol Definition

Attention: See instructions for use.

Caution: Risk of electrical shock.

Laser radiation hazard symbol.

Biological Risks.

Temperature limitations. The upper and lower limits for storage are adjacent to upper and lower
arms.

Upper limit of temperature.

The upper limit for storage is adjacent to the upper arm

Use by or expiration date.

An expiration date expressed as YYYY-MM-DD means the last day the product can be used.
An expiration date expressed as YYYY-MM means the product cannot be used past the last day of
the month specified.

Art: 714363-01D Rev. Date: 01/25/05 1-3

 Symbol Definition

Manufacturer's lot number or batch code. The lot number or batch will appear adjacent to this
symbol.
Catalog number, list number, or reference number. The number adjacent to this symbol is used to
REF reorder the product.
SN Serial number. The serial number will appear adjacent to this symbol.
Model number. The model number will appear adjacent to this symbol.
MN
Date of manufacture.

Manufacturer

In vitro diagnostic medical device.

Authorized Representative for Regulatory Affairs in the European

Community.
Contains sufficient for < n > tests.

Direct Current (DC)

Alternating Current (AC)

Class II Construction

Consult instructions for use or see System Manual for instructions.

CONTROL
Control

Signifies that the product bearing the ETL Listed mark complies with both U.S. and Canadian
product safety standards:

UL 61010A-1
CAN/CSA C22.2 No. 1010.1-92
i/immuno: Cartridges bearing this symbol must be run on i-STAT analyzers that also bear this
symbol.

Battery: i-STAT 1 Analyzer low battery icon (flashes on lower left side of display screen).

1-4 Art: 714363-01D Rev. Date: 01/25/05

 Symbol Definition

Separate waste collection for this electrical/electronic item indicated.

Born On Date: the label BODxxxx-xx defines the year and month of manufacture.
BODxxxx-xx

Symbol The following symbols are used on the i-STAT 1 keypad.

Key used to scan information into the analyzer.

SCAN
Key used to enter letters.
ABC
Key used to enter information.

Key used to access the analyzer's menu.

MENU
Key used to print a test record.

Key used to turn the analyzer off and on.

Symbol The following symbols are used on the i-STAT Portable Clinical Analyzer Keypad

DIS Key used to activate the display.

ENT Key used to enter information.

PRT Key used to print a test record.

CLR Key used to clear an incorrect entry.

Symbol The following symbols are used on i-STAT Value Assignment Sheets

Mean

R Range

Art: 714363-01D Rev. Date: 01/25/05 1-5

 Symbol TEST

Na Sodium

K Potassium

Cl Chloride

Glu Glucose

Lac Lactate

Crea Creatinine

pH pH

PCO2 Partial pressure of carbon dioxide.

PO2 Partial pressure of oxygen.

iCa Ionized Calcium

BUN/ Urea nitrogen/Urea

UREA
Hct Hematocrit

ACTc Activated Clotting Time with Celite® activator.

Celite
ACT
ACTk Activated Clotting Time with Kaolin activator.

Kaolin
ACT
PT/INR Prothrombin Time / International Normalized Ratio

Hb Hemoglobin

TCO2 Total carbon dioxide concentration.

HCO3 Bicarbonate

BE Base excess (b for blood, ecf for extra cellular fluid)

(b&ecf)
AnGap Anion Gap

sO2 Oxygen saturation

cTnI Cardiac Troponin I

CK-MB Creatine Kinase MB Isoenzyme

BNP B-type Natriuretic Peptide

1-6 Art: 714363-01D Rev. Date: 01/25/05

Warranty i-STAT warrants this medical product (excluding disposable or consumable
supplies) against defects in materials and workmanship for one year from the
date of shipment. If i-STAT receives notice of such defects during the warranty
period, i-STAT shall, at its option, either repair or replace products which prove
to be defective. With respect to software or firmware, if i-STAT receives notice
of defects in these products during the warranty period, i-STAT shall repair or
replace software media and firmware which does not execute their programming
instructions due to such defects. i-STAT does not warrant that the operating
of the software, firmware or hardware shall be uninterrupted or error free.
If i-STAT is unable, within a reasonable time, to repair or replace any product
to a condition as warranted, Buyer shall be entitled to a refund of the purchase
price upon return of the product to i-STAT.

Note: Warranty rights may vary from state to state, province to province and
country to country.

Limitations of The foregoing warranty shall not apply to defects resulting from:
Warranty
1 Improper or inadequate maintenance by Buyer or an unauthorized
person,
2 Using accessories and/or consumables that are not approved by i-STAT,
3 Buyer-supplied software or interfacing,
4 Unauthorized repairs, modifications, misuse, or damage caused by
disposable batteries, or rechargeable batteries not supplied by Abbott.
5 Operating outside of the environmental specifications of the product,
or
6 Improper site preparation or maintenance.

THE WARRANTY SET FORTH ABOVE IS EXCLUSIVE AND NO OTHER

WARRANTY, WHETHER WRITTEN OR ORAL, IS EXPRESSED OR IMPLIED.
ABBOTT SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OR
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

Selling or Leasing If you sell an i-STAT analyzer, please notify i-STAT so that we can enter the new
the i-STAT System owner into our software update database. If you rent an i-STAT analyzer and
do not intend to provide software updates to the leaser, please notify i-STAT so
that we can enter the leaser into our software database.

Art: 714363-01D Rev. Date: 01/25/05 1-7

 i-STAT 1 ANALYZER 2
INTRODUCTION

The i-STAT 1 Analyzer is used in conjunction with i-STAT cartridges for the
simultaneous quantitative determination of specific analytes in whole blood
and with the MediSense Precision PCx and PCx Plus Glucose Test Strips for the
quantitative measurement of glucose in whole blood.

Refer to the Cartridge and Test Information section of this manual for
information on analytes that can be measured using i-STAT cartridges.

BEFORE YOU USE THE ANALYZER

Install Batteries Two disposable lithium batteries are supplied with the analyzer. See the Care of
the Analyzer section in this manual for the procedure to install the disposable
batteries. If a rechargeable battery is to be used, the disposable batteries can
be used while the rechargeable battery pack is charged in the Downloader/
Recharger. Charge rechargeable batteries fully before use. See the i-STAT 1
Downloader section for this procedure. When using a rechargeable battery,
store the disposable battery carrier for possible future use.

Check Date and Time Press the On/Off key and check that the date and time at the top of the display
are correct. To change the date and time, see Administration Menu in this
section.

Check Software Caution: New analyzers or analyzers that have been repaired and returned
or replaced will have standard CLEW and application software. If a different
CLEW and/or application software is in use in your facility, it must be installed
in new, repaired or replaced analyzers before they are put into use. Check the
Analyzer Status page for the installed CLEW and application software. See
under “Standardization and Calibration” in section 3 of this manual for an
explanation of CLEW.

Customization Analyzers can be customized for many site-specific testing requirements. See
the Customization section for a list of customizable parameters and their
default values. To change the customization profile via the analyzer keypad
see “Customization” under “Administration” in this section of the manual.
To change the customization profile via the Central Data Station, see the
“Customization Workspace” in the Central Data section of this manual.

Caution: New analyzers or analyzers that have been repaired and returned
or replaced will have the factory default settings in the customization profile,
as indicated by the DEFAULT0 on the Analyzer Status page. If analyzers in
your facility do not use the default customization profile, the appropriate
customization profile should be installed before a new, repaired or replaced
analyzer is put into use.

The i-STAT 1 Analyzer is shipped with the glucose test strip functionality
disabled. The glucose test strip functionality can be enabled through the
Customization function on the Central Data Station or analyzer.

Older i-STAT 1 analyzers may have the test strip port blocked. The test strip
port can be unlocked as follows. A small flat-head screwdriver is needed to
remove the plug.
Art: 714364-01D Rev. Date: 07/12/04 2-1
 1 Hold the analyzer with the test strip port facing you and the display
facing up.
2 Hold the screwdriver with the blade horizontal. Carefully insert the
blade into the horizontal gap under the plug.
3 Pry up gently until the plug pops free. Take care not to force the
screwdriver into the port.
4 Remove the screwdriver and then remove the plug. The plug can be
replaced if necessary.

Perform Quality Use the Electronic Simulator to verify the cartridge-reading performance of
Check new or repaired analyzers.

Use QC protocols to verify the test strip-reading performance of new or repaired

analyzers.

DESCRIPTION
Specifications
DIMENSIONS Width 7.68 cm (3.035 in.)
Length 23.48 cm (9.245 in.)
Depth 7.24 cm (2.85 in.)
WEIGHT With rechargeable battery 650 grams (22.9 oz.)
With disposable battery 635 grams (22.4 oz.)
POWER Two 9-volt lithium batteries, or rechargeable battery.
CALIBRATION Factory: electronic, mechanical, thermal, pressure
MEMORY/CLOCK BACKUP POWER Lithium Battery
DISPLAY Dot matrix supertwist liquid crystal
COMMUNICATION LINK Infrared light-emitting diode (LED)
OPERATING TEMPERATURE 15-40°C (59-104°F) for Medisense strip testing
16-30°C (61-86°F) for i-STAT cartridge testing
TRANSPORT TEMPERATURE -10-46°C (14-115°F)
RELATIVE HUMIDITY 90% (maximum) non-condensing
BAROMETRIC PRESSURE 300-1000 mmHg
LASER SCANNER U.S.21 CFR 1040.10
EN 60825-1 / IEC 60825-1

2-2 Art: 714364-01D Rev. Date: 07/12/04

Software All analyzer functions are controlled by application software that can be updated
as additional tests and features are developed. Coefficients used to maintain
the accuracy of cartridge results over time are programmed into the analyzer
via CLEW software updates every four months. See under “Standardization and
Calibration” in section 3 of this manual for an explanation of CLEW.

Note: Calibration information for the glucose test strips is included in the
barcode on the foil packet in which each test strip is packaged. The
analyzer requires that this information be scanned or entered via the
keypad before the test strip can be inserted into the analyzer.

Power There are two power options for the analyzer: disposable and rechargeable. The
analyzer is shipped with two disposable 9-volt lithium batteries and a battery
carrier. Lithium batteries may be ordered from i-STAT or obtained locally.
ULTRALIFE® lithium batteries (ULTRALIFE Batteries, Inc., Newark, NY, USA) are
recommended. Only i-STAT rechargeable batteries may be used.

Battery The battery compartment is located at the display end of the analyzer next to
Compartment the laser barcode scanner window. The procedure for changing disposable and
rechargeable batteries can be found in the Routine Care of the Analyzer and
Downloader section of this manual.

Disposable Batteries The analyzer requires two 9-volt lithium batteries. The lifetime for a set of
batteries is mainly dependent on the mix of cartridges in use. Cartridges that
require thermal control consume more energy because of heating. Coagulation
and immunoassay cartridges consume more energy because of the longer
test cycle. A minimum of 400 thermally controlled cartridge uses, about 100
coagulation cartridges, 50 immunoassay cartridges, or about 1,000 glucose test
strips can be expected before replacement is necessary. Backlighting, if used
continuously, may reduce battery life up to 50%. Extensive laser scanning will
affect battery life slightly.

The lithium batteries should be removed from the analyzer when long periods,
such as six months, of no use are anticipated.

Rechargeable The analyzer can be powered by a nickel-metal-hydride rechargeable battery.

Battery The battery capacity for one full charge is 30% (minimum) of the capacity of
one set of disposable lithium batteries (see above). If the analyzer is not in
use, batteries will lose approximately 10-30% of their charge over 30 days if
not recharged.

Store rechargeable batteries in a cool dry place when not in use.

The battery recharges when the analyzer is placed in a Downloader/Recharger.

The battery pack can be removed from the analyzer and placed in the separate
recharging compartment on the Downloader/Recharger. Full recharge from a
discharged state takes approximately 40 hours. The analyzer will display “Low
Battery” when battery recharge is needed.

Caution: Do not short circuit, incinerate or mutilate the recharegable

batteries.

Low Battery The analyzer will display “Low Battery” when the On/Off key is pressed and a
Warning flashing battery icon on the result screens when battery replacement is needed.
Data is not lost when batteries are fully discharged.

Art: 714364-01D Rev. Date: 07/12/04 2-3

Additional Power A lithium battery inside the analyzer maintains the clock/calendar and
customization profile. This battery should last seven years.

Cartridge Port Cartridges and the Electronic Simulator are inserted into the analyzer through
the cartridge port on the keypad end of the analyzer. Unless the analyzer is
customized to require information input before a test, inserting a cartridge
or Electronic Simulator initiates the test cycle (i.e., the analyzer does not
need to be turned on first). The cartridge and test strip ports cannot be used
simultaneously.

i-STAT Cartridge Port

Test Strip Port Precision PCx and PCx Plus Blood Glucose Test Strips are inserted into the
analyzer through the test strip port on the display end of the analyzer when
prompted by the analyzer.

Precision PCx and PCx Plus

Glucose Test Strip Port
Infrared Communication
Window

Battery Compartment Laser Barcode Scanner

Window

2-4 Art: 714364-01D Rev. Date: 07/12/04

Infrared The Infrared Communication Window provides the analyzer with two-way
Communication communication to the Central Data Station via a Downloader, allows analyzer-
Window to-analyzer software updates, and allows analyzer-to-printer communication
for printing.

Thermal Control The analyzer contains a thermal control subsystem of thermistors and heating
contact wires that controls the temperature of the sensors and fluids that come
into contact with the sensors to 37°C. This subsystem is activated automatically
when a cartridge containing tests which require thermal control at 37°C is
inserted into the analyzer.

Barometric Pressure The analyzer contains a solid-state barometric pressure sensor, which determines
Sensor the ambient atmospheric pressure used for the PO2 sensor calibration.

Cartridge Test Cycle An operator starts a cartridge test cycle either by inserting a cartridge into the
analyzer or by selecting the i-STAT Cartridge option from the Test or Quality
Tests Menu.

The analyzer:
 makes electrical contact with the cartridge
 identifies the cartridge type
 releases calibration fluid to the sensors (when applicable)
 mixes sample and reagent (when applicable)
 measures barometric pressure
 heats the sensors to 37°C (when required by the test )
 measures electrical signals generated by the sensors and calibration
fluid (when applicable)
 displaces the calibrant solution with sample (when applicable)
 measures electrical signals generated by the sensors and sample
 accepts the operator and patient IDs scanned or entered by the
operator
 accepts chart page information
 calculates and displays results
 stores results

Strip Test Cycle An operator starts a test strip test cycle by selecting the PCx Glucose Strip option
from the Test or Quality Tests Menu.

The analyzer:
 accepts test strip lot data
 prompts the operator to insert the test strip
 prompts the operator to apply the sample
 measures electrical signals generated by the glucose sensor and
sample
 accepts the operator and patient IDs scanned or entered by the
operator
 accepts chart page information entered by the operator
 calculates and displays results
 stores results

Art: 714364-01D Rev. Date: 07/12/04 2-5

Data Entry Data that can be scanned into the analyzer or entered via the keypad
include:
 Operator ID
 Patient ID, Proficiency ID, or Simulator ID
 Cartridge and Strip Lot Number
 Control Lot Number
 Cal Ver Kit Lot Number
 Comment codes for patient and
control results
 Chart Page
• Sample Type
• Patient Temperature
• FIO2
• Free Fields: three fields, up to 9
characters each

See the Customization section in this manual for

barcode formats recognized by the analyzer.

Storage of Results The analyzer automatically stores up to 5,000 test records. A test record consists
of:

 a set of results
 the date and time the test was performed
 the cartridge type
 all information entered by barcode scanner or keypad including:
• Operator and Patient IDs
• Lot numbers for controls, cartridges and test strips
• Chart page data
• Serial number of the Electronic Simulator
 the serial number of the analyzer
 the number of times the analyzer has been used
 the software and CLEW versions installed in the analyzer
 the name of the analyzer’s customization profile

Quality Check Codes, which may appear during the test cycle indicating a
problem with the sample, calibration, sensors, mechanical or electrical functions
of the analyzer, are also stored.

The Analyzer Status option under the Administration Menu lists the number
of stored records as “Total” and “Unsent” records. Test records are stored as
“Unsent” until the analyzer uploads data to the Central Data Station at which
time the records are marked as sent. The analyzer can be customized to display a
Memory Full prompt or to disable testing until data is transmitted to the Central
Data Station. Otherwise, the oldest data is overwritten when the memory
becomes full. Stored test records can be reviewed through the Data Review
option on the Administration Menu screen described later in this section.

2-6 Art: 714364-01D Rev. Date: 07/12/04

LCD Display and Test results, operator prompts and other messages are displayed on the analyzer’s
Backlight LCD Screen. The backlight for the display is turned on and off by pressing the
0 key for one second. The backlight will automatically turn off after ninety
seconds and when the analyzer powers down or is turned off. The backlight
cannot be turned on while data entry screens are displayed.

Audible Indicator The analyzer will beep to indicate:

 whenever a key is pressed.
 a successful barcode entry.
 sample detection on glucose test
strip tests.
 results are ready.
 a Quality Check Message is
displayed.

The analyzer can be customized to disable

beeping when a key is pressed or results or
messages are displayed.

Time Out The analyzer automatically turns off after a

certain period of inactivity.

 Results displayed: Results are displayed for 2 minutes before the analyzer
turns off provided that a mandatory Comment Code prompt is not
displayed. This Inactivity Time Out default time can be increased using
Customization.

If a mandatory Comment Code prompt is displayed, the analyzer will

turn off after 15 minutes or after the Inactivity Time Out, whichever is
greater. In the case of a missed required Comment Code, results will be
stored and “_ _ _” will be entered as the Comment Code.

 Prompting for mandatory data when results are ready for display:
The analyzer will turn off after 15 minutes or after the Inactivity Time
Out, whichever is greater, if there is no response to a mandatory data
prompt. A mandatory data prompt is a prompt for information that must
be entered before pending results are displayed.

In the case of a missed mandatory data prompt, results will not be stored
and the test record will state “Test Cancelled by Operator.”

 Waiting for insertion of cartridge: After the prompt “Insert Cartridge”

is displayed, the analyzer will wait 15 minutes for the operator to insert a
cartridge unless the analyzer is in the Proficiency path, in which case the
analyzer will wait 5 minutes. If a cartridge is not inserted, the analyzer
will turn off. This timeout cannot be customized.

 Waiting for insertion of test strip: After the prompt “Insert Strip” is
displayed, the analyzer will wait 2 minutes for the operator to insert a
test strip. If a test strip is not inserted, the analyzer will turn off. This
timeout cannot be customized.

 Other: The analyzer will turn off after 2 minutes of inactivity (no keys
pressed) in all other circumstances.

Art: 714364-01D Rev. Date: 07/12/04 2-7

Keypad There are 19 keys located directly below the display. When using the keypad to
enter information, the number of dashes in the data entry line will indicate how
many characters can be entered on the line. The dash where the next entry will
be placed will flash.

KEY FUNCTION

SCAN Activates the barcode scanner. Information that can be entered

into the analyzer via the scanner includes: operator ID, patient
ID, control, cartridge and test strip lot number, patient chart
data and comment codes.

Used to move the cursor on the Set Clock screen and to move
up and down the alphabet when the ABC key is pressed. The →
(right arrow) key is used as a page key to move from one screen
to the next. When Patient ID Recall is enabled, the → key will
recall the last patient ID when the analyzer is prompting for
Patient ID. The ← (left arrow) key is used to backspace and
clear keypad entries, and to move backward through the screens
within a menu.

ABC Used to enter alpha characters on data entry screens. When

the ABC key is pressed the letter A is entered. The arrow keys
are used to move up and down the alphabet. To enter a second
letter, press the ABC key once to move to the next position and
again to enter an A. To enter a number after a letter, press a
numbered key. To erase a letter, press the ABC key to move to
the next position, then use the ← key to backspace and clear
the letter.

0–9 Used to enter digits on data entry screens and to select menu
options and stored records.

• Enters a decimal point or a comma separator according to the

analyzer’s Customization Profile.

Used to turn the screen backlight on and off.

Enter Used to respond to a prompt to complete an action, such as

entering an operator or patient ID via the keypad.

MENU Used to return to the previous menu and switch between the
Test and Administration Menus.

Print Used to print either directly to the portable printer or to the

portable printer attached to a Downloader.

On/Off Turns the analyzer on or off. When the analyzer is on, the
On/Off key must be pressed for a second to turn the analyzer
off. This key is inactive when a test is in progress and when
the analyzer is prompting for mandatory data.

2-8 Art: 714364-01D Rev. Date: 07/12/04

i-STAT 1 Menu Tree There are two main menus: The Test Menu and the Administration Menu. If the
glucose test strip function is disabled, test strip options will not be displayed.

Test Menu Administration Menu

1- Last Result 1. Analyzer Status Temp

2- i-STAT Cartridge Pressure
3- PCx Glucose Strip 1- Patient Battery
2- Control Uses
Serial
CLEW
Version
Custom
Stored Records

2- Data Review 1-Patient

2-Control 1- i-STAT Cartridge

2- PCx Glucose Strip
3- All

3-Proficiency 1- i-STAT Cartridge

2- PCx Glucose Strip
3- All

4-Cal Ver 1- i-STAT Cartridge

2- PCx Glucose Strip
3- All
5- Simulator
6- All
7- List

3-Quality Tests 1-Control 1- i-STAT Cartridge

2- PCx Glucose Strip

2- Proficiency 1- i-STAT Cartridge

2- PCx Glucose Strip

3- Cal Ver 1- i-STAT Cartridge

2- PCx Glucose Strip

4- Simulator

4- Customization 1- View

2-Change 1- Analyzer
2- ID Entry
3- Patient Tests
4- QC Tests
5- Results
6- Password
7- Restore Factory
Settings

5- Set Clock

6- Transmit Data 1- Most Recent

2- This Month
3- Last Month
4- All

7-Utility 1- Send Software

2- Clear Memory

Art: 714364-01D Rev. Date: 07/12/04 2-9

TEST MENU

The Test Menu is displayed when the analyzer is

turned on using the On/Off key.

The options are:

1 - Last Result
2 - i-STAT Cartridge
3 - PCx Glucose Strip
1 - Patient
2 - Control

Options 2 and 3 are used for testing patient

samples. For the glucose test strip, controls
can also be tested from the Test Menu. Testing
controls from the Test Menu rather than option
3 – Quality Tests under the Administration Menu
may be more convenient for end users who test
glucose test strip control samples on a daily
basis.

Note: If the analyzer is customized with test

strip testing disabled, test strip options
will not be displayed. If the analyzer
is customized to disable testing under
certain conditions, the disabled option
will be listed without its number so that
it cannot be selected.

ADMINISTRATION MENU
Overview The Administration Menu is accessed by pressing
the Menu key from the Test Menu screen. The
options are:
1 - Analyzer Status
2 - Data Review
3 - Quality Tests
4 - Customization
5 - Set Clock
6 - Transmit Data
7 - Utility

2-10 Art: 714364-01D Rev. Date: 07/12/04

Analyzer Status The Analyzer Status screen contains information about the condition or “status”
of the analyzer. Fresh readings are made whenever this option is selected.

Temp Room temperature.

Pressure Barometric pressure.
Battery Battery voltage.
Uses Total number of cartridge,
simulator and test strip test
cycles, whether or not results
reported.
Serial Serial number of the analyzer.
CLEW Version of standardization data
installed in the analyzer.
Version Version of application software
installed in the analyzer.
Custom Customization profile name.
Stored Total: The number of test records in the analyzer’s
Records memory. The maximum storage capacity is 5,000 test
records, which include records with results and Quality
Check Codes for patients and controls both liquid and
electronic.
Unsent: The number of test records that have not been
transmitted to the Central Data Station.

Data Review The Data Review function allows the operator to review stored results by the
categories listed below. The number of test records stored is indicated at the
bottom center of the screen as x/y where x is the record on the screen and y is
the total number of stored records in the selected category. The 1 and 2 keys
are used to scroll through the stored records as indicated on the bottom right
and left of the screen. The most recent test record is always in the first position.
The right arrow key is used to page through the
screens of the displayed record.

1 - Patient The records for a patient

are recalled by scanning
or entering via the keypad
the Patient ID. If no
Patient ID is entered, all
patient tests are recalled.
2 - Control 1 – i-STAT Cartridge
2 – PCx Glucose Strip
3 - All
3 - Proficiency 1 – i-STAT Cartridge
2 – PCx Glucose Strip
3 - All
4 - Cal Ver 1 – i-STAT Cartridge
2 – PCx Glucose Strip
3 – All
5 - Simulator All external and internal Electronic Simulator
records.

Art: 714364-01D Rev. Date: 07/12/04 2-11

 6 - All All test records in the
analyzer’s memory.
7 - List Records are listed with
Cartridge type or PCx
Glucose Strip, date
and time of test, and
patient ID, control lot,
proficiency ID, or Cal
Ver lot and test level
as applicable. Any
number of test records
can be selected for
viewing or printing
using the number keys.
Pressing the number key
corresponding to a record
selects a record; pressing the number key a second
time deselects the record.

To view one or more records, select the records

and press the Enter key. To print records, select
the records and press the Print key.

Quality Tests Non patient tests can be initiated from the Quality Tests menu. Options are:
1 - Control
2 - Proficiency (external quality control)
3 - Cal Ver (Calibration Verification
for cartridges and Linearity
Test for test strips)
4 - Simulator (cartridge-reading function
only)

When options 1 - 3 are selected, the operator

further selects:
1 – i-STAT Cartridge
2 – PCx Glucose Strip
When testing is initiated from one of these
options, the analyzer prompts the operator to
scan or enter the Operator ID; the Control Lot
Number, Proficiency ID, Cal Ver Kit Lot Number, or Simulator ID as applicable;
and the Cartridge Lot Number or Test Strip Lot Number as applicable.

When the Quality Tests option is used, results can be reviewed according to
the corresponding options under the Data Review option.

Note: The Test Menu option for test strips includes both a Patient and Control
option. Results for test strip controls run from the Test and Quality Tests menus
are stored together.

2-12 Art: 714364-01D Rev. Date: 07/12/04

Customization Analyzers can be customized for site-specific testing characteristics and
requirements. A complete list of customizable parameters and their default
values can be found in the Customization section. An analyzer can be customized
via the keypad or via the Central Data Station. Items that cannot be customized
via the analyzer’s keypad are operator lists, test strip lists, reference and action
ranges, sample types and order of items on the Chart page.

The Central Data Station’s Customization function can be used to create one
customization profile for all analyzers or different profiles for different locations.
When the Customization function is enabled, the profiles are transmitted to
the analyzers when they are placed in a Downloader.

Caution: If location specific customization profiles are created, analyzers should

not be moved from one location to another unless they are re-customized for
the new location. This is especially important if “CPB: Automatically Adjust”
or “CPB: Do Not Adjust” is included in a location-based customization profile.
The CPB function adjusts hematocrit and hemoglobin results for the dilutional
affect of pump fluid during cardiopulmonary bypass surgery. If an analyzer
customized for the CVOR as “CPB: Automatically Adjust” is used for patients
who are not on the pump, hematocrit results will be reported falsely high. If
an analyzer customized as “CPB: Do Not Adjust” is used for patients who are
on the pump, hematocrit results will be reported falsely low. For details on the
CPB function, see the Theory section of this manual.

It is recommended that only one method, the Central Data Station or the
keypad, be used to customize all analyzers within a site. If both methods are
in use, and the Customization function is not disabled on the Central Data
Station, any changes made to the profile of an analyzer via the keypad will be
overwritten the next time the analyzer is placed in a Downloader.

The customization profile of an analyzer is identified in the Customization

option under the Administration Menu on the analyzer. DEFAULT0 indicates
that the analyzer has factory settings. When an analyzer has been customized
via the Central Data Station (CDS), the name assigned to the profile by the CDS
is listed. If the default or CDS profile is changed on the analyzer, the profile
is listed as 00000000.

Note: The i-STAT Portable Clinical Analyzer and the Philips Medical Systems
Blood Analysis Module can be customized only from the Central Data Station.
However, not all customizable features apply to these two analyzers. See the
i-STAT System Manual for the i-STAT Portable Clinical Analyzer for customizable
features for this analyzer and the Blood Analysis Module.

Art: 714364-01D Rev. Date: 07/12/04 2-13

Viewing the Select 4- Customization from the Administration Menu, select 1- View then
Customization select from the Customization Menu:
Profile
1 - Analyzer
2 - ID Entry
3 - Patient Tests
4 - QC Tests
5 - Results
Select a category to review. Use the ← and → keys to scroll through the
preferences for each category and use the ← key to return to the Customization
menu.

The Customization review option on the analyzer does not display the certified
operator list or the valid test strip lot list. These items can be viewed on the
Central Data Station.

Changing the Profile To customize via the analyzer keypad, select 4- Customization from the
Administration Menu, then select 2- Change. If the analyzer has already been
customized with a password, enter the password. If not, press the Enter key.
(It is recommended that the Change function be password protected). Then
make selections from the Customization menu. To change a setting, select
the item by pressing the number key correponding to the item, then select the
setting. Use the → key to view all items. After all items have been set, turn
the analyzer off to save and activate the settings.

Note:
• Outside the USA, the following changes should be considered:
language, unit set, date format and decimal separator.

1 - Analyzer
first page
1 Language
2 Date Format
3 Sound
4 Auto-transmit
5 Memory Full
second page
1 Batch Mode
2 Inactivity Timeout
3 Upload Schedule
4 PCx Glucose Test Strip
5 Clock Password
third page
1 Sync Clock

2-14 Art: 714364-01D Rev. Date: 07/12/04

 2 - ID Entry
1 – Operator
first page
1 Minimum Length
2 Maximum Length
3 Repeat ID
4 Manual Entry
5 Code I2of5
second page
1 Code 128
2 EAN-8, EAN-13
3 Codabar
4 Code 93
5 Code 39, Full ASCII
third page
1 Code 39, Check Digit
2 Truncate First x Digits
3 Truncate Last x Digits
4 Print ID

2 – Patient
first page
1 Minimum Length
2 Maximum Length
3 Repeat ID
4 ID Recall
5 Manual Entry
second page
1 Code I2of5
2 Code 128
3 EAN-8, EAN-13
4 Codabar
5 Code 93
third page
1 Code 39, Full ASCII
2 Code 39, Check Digit
3 Truncate First x Digits
4 Truncate Last x Digits

3 - Patient Tests
first page
1 Cartridge Auto-chart
2 Strip Auto-chart
3 Cartridge Information
4 Cartridge Barcode
5 Cartridge Lot Number
second page
1 Comment Code, In Range
2 Comment Code, Out of Range
3 Strip Sample Type
4 Result Output
5 Downloader Lockout

Art: 714364-01D Rev. Date: 07/12/04 2-15

 4 - QC Tests
1 – Simulator
1 External Simulator
2 External Simulator Schedule Option
3 Internal Simulator
4 Internal Simulator Schedule Option
2 – Strip Controls
1 Schedule
2 Mid Level Control
3 Comment Code, In Range
4 Comment Code, Out of Range

5 - Results
1 – Units and Ranges
2 – Options
first page
1 Decimal Separator
2 Test Selection
3 Hematocrit (CPB and EDTA)
4 Base Excess
5 ACT-C Cal Options
second page
1 ACT-K Cal Options
2 Print Reference Ranges

6 - Password

7 - Restore Factory Settings

2-16 Art: 714364-01D Rev. Date: 07/12/04

Set Clock If the analyzer is customized with a password, the Set Clock function will be
password protected. If a password has not been assigned, pressing the Enter key
will display the time and date screen. Use the arrow
keys to move the cursor to the digit to be changed. Use
a number key to change the digit. Press Enter to accept
the changes or Menu to cancel the changes. An invalid
entry, such as 13 for a month, will not be accepted.

The format of the date on this screen can be customized

using the Central Data Station Customization function,
as mm/dd/yy or dd/mm/yy. The analyzer recognizes
years in which February has 29 days.

The analyzer can be customized using the Central Data

Station to synchronize or update the real time clock
to the Central Data Station's clock at the time of each
download. This option eliminates the need to reset the analyzer's clock at the
beginning and end of Daylight Saving Time. Otherwise, the clock must be
manually changed for Daylight Savings Time changes.

Transmit Data Unsent test records are automatically transmitted to the Central Data Station
when an analyzer is placed in a Downloader or Downloader/Recharger. In
some cases it may be desirable to have the capability to retransmit data. The
Transmit Data function allows transmission of data
in the following manner:

1 – Most Recent
2 – This Month
3 – Last Month
4 – All

Most Recent is the result from the last cartridge or

test strip tested.

The analyzer can be customized using the Central Data

Station to apply a date range limit to the Transmit All functions.

Auto-transmit is temporarily disabled when the Transmit Data option is selected

to allow the user to control transmission of data.

Utility The Utility menu can be password protected using the Customization function
on the analyzer or Central Data Station.

1– Send Software: Allows the analyzer to transmit software to

another analyzer. See the Software Update
section of this manual.
2– Clear Memory: Erases results from the
analyzer’s memory. Options are:
1– Previous to 01MMMYY (where MMMYY is
current month and year, such as 01JUN00)
2– Previous to 01mmmyy (where mmmyy
is previous month and year, such as
01May00)
3– All
4– Cancel

Art: 714364-01D Rev. Date: 07/12/04 2-17

LASER BARCODE SCANNER
Laser Barcode The barcode scanner is used to scan barcode information into the analyzer.
Scanner Parameters that can be entered into the analyzer via the scanner include:
operator and patient IDs, control, cartridge and test strip lot numbers, comment
codes and patient chart data. The laser beam emerges from the recessed window
on the front of the analyzer adjacent to the battery compartment. The laser
beam automatically turns off after 3 seconds or after the barcode is successfully
scanned.

Laser Specifications The barcode scan engine is manufactured by Symbol Technologies Corporation.
The scan engine contains a laser diode that emits laser radiation at a frequency
of 650 nm. The scan engine outputs power (i.e., the power output of the engine
if removed from this product) up to 1.2 mW in scanning mode. The scanner in
this product only operates when the Scan key is pressed. Symbol Technologies
Corporation intends this engine to be used in a Class 2 device and this product,
with the enclosed engine, meets the requirements of CFR (Code of Federal
Regulations) Title 21 Ch.I Part 1040 Class II and IEC60825-1 Class 2.

Warning Labels Warning labels are shown below. The warning labels are located on the back
or under-side of the analyzer, as shown. The location of the laser window from
where the analyzer emits the laser beam is also shown below.

Laser Barcode Scanner

Window

2-18 Art: 714364-01D Rev. Date: 07/12/04

Caution Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation.

Do not open the analyzer. The analyzer may only be opened by factory or
factory authorized service personnel. Opening the analyzer may result in
exposure to hazardous laser radiation.

Do not look into the laser aperture or point the laser beam at other
persons. Staring into the laser aperture may cause hazardous exposure to laser
radiation.

Procedure Before scanning, check to see what information is required by the displayed
prompt. Hold the analyzer 3-12 inches (2.5 – 30.5cm) from the barcode to be
scanned. An angle of about 10 degrees from perpendicular is best. Hold the
analyzer and place the object to be scanned on a flat surface or, place the analyzer
on a flat surface and hold the object in front of the analyzer. Avoid accidentally
scanning other nearby items. Avoid pointing the beam into anyone’s eyes.

STEP ACTION

1 Press and hold down the Scan key to start the barcode scanner. The
analyzer emits a visible red beam.

2 Position the analyzer and barcode so the beam forms a red line that
spans the entire barcode. Increasing distance between the barcode and
analyzer lengthens the red line. The analyzer does not need to touch
the barcode.

3 When the analyzer accepts the barcode, it will beep in acknowledgement

and automatically turn off the beam. The beam will also turn off after
3 seconds.

4 View the data that was scanned by the analyzer and verify that it is
correct.

5 Release the Scan key.

Note: If the Scan key is released as soon as the beep is heard, the next prompt
will be displayed and the information scanned will not be able to be
viewed.

PROMPTS AND MESSAGES

Prompts Either before or during the testing cycle, the analyzer will display prompts
that require an operator action or keypad entry, such as “Enter Operator
ID.” Prompts are described in the manual when used. Some prompts require
input before results are displayed. Prompts for the following information are
mandatory:

 Operator ID
 Patient ID
 Lot Number for Test Strips
 Lot Numbers for Quality Tests

Art: 714364-01D Rev. Date: 07/12/04 2-19

Startup Messages When the On/Off key is pressed the analyzer may display one or more startup
messages. A startup warning message indicates an action that should be taken
in the near future to maintain the analyzer in working condition. If the analyzer
is customized to disable testing under certain conditions, a startup lockout
message indicates the action that must be taken before testing is re-enabled.

Quality Check If the analyzer detects a problem during power on, a Quality Check message
Messages will be displayed indicating the action that must be taken before testing can
begin.

A Quality Check message will also be displayed and testing halted if the analyzer
detects a problem during the test cycle.

Startup messages and Quality Check messages are described in the

Troubleshooting section of this manual. “Upload Required, Testing Disabled”
is an example of a startup lockout message, “Battery Low ” is an example of a
startup warning message, and “Unable to Position Sample” is an example of a
quality check failure during the testing cycle.

Note: The “Cartridge Locked” or “Simulator Locked” prompt is always

displayed when a cartridge or Electronic Simulator is inserted into the
analyzer. Any attempt to remove a cartridge or Electronic Simulator
before this prompt is removed from the screen may cause damage to
the analyzer.

2-20 Art: 714364-01D Rev. Date: 07/12/04

 i-STAT CARTRIDGE 3
Contents The unit-use disposable cartridge contains many of the subassemblies typically
found in complex laboratory systems. Microfabricated thin film electrodes or
sensors are assembled in unit-use cartridges containing:
• calibrant solution in cartridges with sensors for blood gases,
electrolytes, chemistries and hematocrit
• reagents in cartridges with sensors for coagulation
• sample handling system
• waste chamber
• an array of miniaturized sensors
• conductive pads to make electrical contact with the analyzer
• heating elements in cartridges requiring thermal control at 37 °C
See the Cartridge and Test Information Sheets for test-specific details.
The following diagram shows how a typical blood gas/chemistry cartridge is
constructed.

Art: 714365-01C Rev. Date: 07/12/04 3-1

 Sample Handling Part Function
System
Sensor Channel The sensor channel directs the sample from the
sample chamber to the sensors. An extension of this
channel becomes a waste chamber to receive the
Contact
calibrant solution as it is displaced by the sample.
Sensors Pads
Air Chamber An air chamber is located in blood gas/electrolyte/
chemistry/hematocrit cartridges between the sample
chamber and sensor channel. This creates an air
segment between the calibrant solution and the
sample to prevent the two from mixing. The size of
the air segment is monitored by the analyzer.
Sample Chamber The sample chamber includes the sample well and
the channel leading from the well up to the fill mark.
When filled, the sample chamber contains sufficient
sample for testing. Sample volume and placement are
monitored by the analyzer.
Bladder The bladder (concealed by the label) is connected to
the sample well. The analyzer presses on the bladder
to displace calibrant solution from the sensors, to
move the sample from the sample chamber to the
sensors or to mix sample and reagents.
Snap Closure The snap closure creates an airtight seal necessary
for proper fluid movement within the cartridge.
Sample Well The closure also ensures that calibrant and sample
remain contained within the cartridge during the
testing cycle and subsequent disposal. Immunoassay
cartridges, such as cTnI, use a plastic slide enclosure
clip.
Air Vent An air vent on the underside of the cartridge, beyond
the fluid front, allows the calibrant and the sample to
flow forward, but not out of the cartridge.
Waste Chamber A waste chamber (beneath the cartridge label) holds
calibrant fluid after it has been used.

Sensors The sensors are electrodes microfabricated on silicon chips. Electrodes have
chemically sensitive coatings such as ion-selective membranes and enzyme
layers. In cartridges that perform coagulation tests, reagents, such as clot
activators, are coated on the plastic above the sensors. Each sensor is connected
to a contact pad by a signal line. The sensors respond to the calibrant
solution and the sample by producing measurable signals related to analyte
concentration. The performance characteristics for each sensor are described
in the Cartridge and Test Information section. The section on theory describes
the measurement principles.

Contact Pads The contact pads conduct the signals generated by the sensors to the analyzer.
In order to function properly, care must be exercised not to contaminate the
contact pads during cartridge handling.

Heating Elements Cartridges that require thermal control at 37°C include heating elements on the
underside of the sensor chips which are contacted and heated by the analyzer’s
thermal probes.

3-2 Art: 714365-01C Rev. Date: 07/12/04

Standardization and Standardization is the process by which a manufacturer establishes “true”
Calibration values for representative samples. The sensors in the i-STAT cartridges are
standardized against plasma methods used by major laboratory systems or,
for blood gases, against tonometry. A multi-point calibration curve, the
slope or sensitivity of which is defined by coefficients in the CLEW software,
is derived for each sensor by this standardization process. These calibration
curves are stable over many lots and only need to be adjusted if a change in a
manufacturing process affects the curve or if the relationship between results
on the i-STAT System and other major laboratory systems drifts. For the
convenience of users, CLEW updates are scheduled three times a year.
A one-point calibration is performed each time a cartridge requiring calibration
is used. During the first part of the testing cycle, the calibrant solution is
automatically released from its foil pack and is positioned over the sensors.
The signals produced by the sensors’ responses to the calibrant solution
are measured. This one-point calibration adjusts the offset of the stored
calibration curve. Next, the analyzer automatically moves the sample over the
sensors and the signals produced by the sensors’ responses to the sample are
measured. While coefficients are used rather than graphic calibration curves,
the calculation of the result is equivalent to reading the sample’s concentration
from adjusted calibration curve.

Packaging Each cartridge is sealed in a foil pouch or clear plastic portion pack for
protection during storage.

Labeling on the carton, box and pouch/portion pack identify:

• the panel name.
• the tests included in the panel.
• the lot number.
• the expiration date of the cartridge.

If the pouch/portion pack has been punctured, the cartridge should not be
used.

Rev. Date: 07/12/04 Art: 714365-01C 3-3

 Storage Conditions The main supply of cartridges should be stored at 2-8°C (35-46°F). Cartridges
must be at room temperature before removing them from their pouches. Allow
5 minutes for an individual cartridge and one hour for a box of 25 cartridges
to come to room temperature. Cartridges in use may be stored at room
temperature (18-30°C or 64-86°F) for two weeks. The cartridge box contains a
line used to indicate the two-week room temperature expiration date.

Disposal Although the sample is contained in the cartridge, cartridges should be

disposed of as biohazardous waste, according to local, state, and national
regulatory guidelines.

3-4 Art: 714365-01C Rev. Date: 07/12/04

 PRECISION PCx and PCx™ Plus BLOOD GLUCOSE TEST STRIPS 4
Detailed Information See the package insert included with each box of glucose test strips for
information not included in this manual:

² Summary and Principle

² Reagents
² Storage and Handling
² Precautions
² Expected Results for Precision, Precision•G®, MediSense®
Control Solutions
² Limitations of the Procedure
² Performance Characteristics

Packaging Each test strip is wrapped in a foil packet with a barcode label. This label holds
the calibration information about the test strip, including:

² Lot number
² Expiration date
² Expected control solution ranges
² Lot-specific calibration information

Example of test strip barcode label

Disposing of Waste Discard used test strips in an approved biohazard container.

Art: 714366-01B Rev. Date: 03/29/04

4-2 Art: 714366-01B Rev. Date: 03/29/04
 ELECTRONIC SIMULATOR 5
Overview The Electronic Simulator, external and internal, is a quality control device
for the analyzer’s cartridge signal-reading function. It simulates two levels of
electrical signals that stress the analyzer’s cartridge signal detection function
both below and above measurement ranges.

While the analyzer performs internal electronic checks and calibration during
each test cycle, the Electronic Simulator test provides an independent check
on the ability of the analyzer to take accurate and sensitive measurements of
voltage, current and resistance from the cartridge. An analyzer will pass or
fail this electronic test depending on whether or not it measures these signals
within limits specified in the analyzer software.

The schedule for the Electronice Simulator can be customized to meet local,
state, or national accreditation requirements. A reminder message for the
operator to run the external simulator can be set by the number of hours on
the i-STAT Portable Clinical Analyzer and by the hours or tests on the i-STAT 1
Analyzer. The schedule for the automatic internal Electronic Simulator can be
set by the number of hours on the i-STAT Portable Clinical Analyzer and by the
hours or tests on the i-STAT 1 Analyzer. For details and lockout options, see the
Customization section of this manual.

Relative Humidity The Electronic Simulator test will fail if high humidity interferes with the
measurements. Therefore it is not necessary to record humidity where the
analyzers are in use.

Internal Simulator When the specified time has elapsed since the last Electronic Simulator test
(internal or external), the internal test will automatically be performed when a
cartridge is inserted before the sample is tested, adding about 20 seconds to the
testing cycle.

External Simulator The external Electronic Simulator is a stable electronic device, which is inserted
into the cartridge port. The test cycle for the external Electronic Simulator is
about 60 seconds. (The test cycle for the internal simulator is shorter because
it shares the initial part of the test cycle with the cartridge.)

Art: 714367-01B Rev. Date: 07/18/03 5-1

Operating
Operating Characteristics
Characteristics
Dimensions Height 1.9 cm
Width 7.0 cm
Length 9.0 cm
Weight 85 g
Operating Same as Analyzer
Temperature being tested
Operating Ambient 0-90% RH
Humidity non-condensing
(as shipped)
Storage Temperature -20-50˚C
(-4-122˚F)

Even when the internal Electronic Simulator is enabled, an external Electronic

Simulator is needed:

• to validate an internal simulator failure.

• to reset the internal simulator schedule if a
simulator test might interrupt testing, such
as in a CVOR.
Note: CVOR = Cardiovascular Operating Room
• for on-demand testing at any time.
• to perform the thermal probe check.
• to access the Proficiency and Calibration Verification test paths on
the i-STAT Portable Clinical Analyzer.

The external Electronic Simulator should be stored in the static-free box in

which it is shipped and the blue cap should be replaced after each use to
protect the contact pads.

Stored Result The results of the Simulator test are stored as a distinct record in the analyzer
and can be transmitted to the Central Data Station.

Use … Use of the Electronic Simulator is described further in the Quality Control
section of this manual.

Cleaning the Before cleaning, cover the connector area with the blue rubber boot. This
Simulator will minimize the possibility of any cleaning fluid getting into the simulator
housing, thus contaminating the internal circuitry.

Clean the simulator with a gauze pad moistened with any of the cleaning
agents approved for the analyzer, listed on page 17-1 of this manual.

Rinse the simulator using another gauze pad moistened with water and dry.
DO NOT IMMERSE THE SIMULATOR IN ANY FLUID, AT ANY TIME.

If the connector itself is contaminated, the user should contact their Support
Representative and arrange to have the simulator returned.

5-2 Art: 714367-01B Rev. Date: 07/18/03

 i-STAT 1 DOWNLOADER 6
Function The Downloader converts infrared transmissions of test records from the
analyzer to electrical form and transmits (uploads) them to the Data Manager.
The Downloader also converts electrical signals from the Central Data Station
to infrared transmissions, which are transmitted (downloaded) to the analyzer.
Transmission is automatic when an analyzer is placed in a Downloader.

The Downloader comes in two formats:

² Downloader: A low-profile table-top unit with “arms” between

which the analyzer is placed, and
² Downloader/Recharger (DR): a cradle that the analyzer is placed
within.

Both Downloader formats are available for use with direct wiring (serial format)
or ethernet cabling (network format). Unless indicated otherwise, references
to the Downloader apply to the Downloader/Recharger as well.

The Downloader/Recharger can recharge a rechargeable battery in the analyzer.

If the analyzer contains a rechargeable battery, the battery begins recharging
automatically as soon as the analyzer is placed in the Downloader/Recharger.
The Downloader/Recharger also has a compartment for recharging a rechargeable
battery outside the analyzer.

Proximity Power Light

Light
Proximity
Infrared Transceiver Light

Charging Light (bat-

tery in analyzer)
Infrared
Transceiver

i-STAT 1 DOWNLOADER Recharging

Compartment Gold
Charging
Contacts
External
Battery Pack
Charging
Light

i-STAT 1 DOWNLOADER/RECHARGER

Art: 714368-01D Rev. Date: 04/04/04

Specifications
Specification Downloader Downloader/Recharger
Size 5.25in (13.3cm) Wide 4.12in (10.4cm) Wide
6.75in (17.2cm) Long 10.25in (26.cm) Long
2.13in (5.4cm) High 5.00in (12.7cm) High

Weight 0.6 lbs (0.27kg) 1.2 lbs (0.55kg)

Power AC-DC power adapter AC-DC power adapter
or PC/Downloader adapter. or PC/Downloader adapter.*
Input 12V Input 12V

Operating 0 to 40˚C 0 to 40˚C

Temperature 32 to 104˚F 32 to 104˚F

Storage Temperature -20 to 50˚C -20 to 50˚C

-4 to 122˚F -4 to 122˚F
Pollution Degree (Allowable 2 2
ambient pollution level)

Installation Category (Allowable 2 2

overvoltage specification)

Communication To Central Data Serial (RS232), or Serial (RS232), or

Station and other equipment Ethernet Ethernet

Communication Link To and Infrared Transceiver Infrared Transceiver

From Analyzer
Indicator LEDs
Power Green NA
Proximity Red Blue
Charge NA Red/Green
Configuration By host computer By host computer

Power Supply
Specification Downloader and
Downloader/Recharger
Input 100 - 240V~
47 - 63 Hz
.9 - .5A
Output 12V
3A max

* Recharge feature cannot be used in this configuration.

Running Cartridges All current i-STAT Cartridges may be run in an analyzer that is docked in a
in an Analyzer Downloader/Recharger.
Docked in a
Downloader/
Recharger

6-2 Art: 714368-01D Rev. Date: 04/04/04

Downloader/
Analyzer Battery LED (near top of Downloader/Recharger)
Recharger Indicator
LEDs Off No Rechargeable Battery
Blinking Red Fast Charge Pending
Solid Red Fast Charging
Solid Green Trickle Charging
SPARE BATTERY (near middle of Downloader/Recharger)
Off No Rechargeable Battery
Green Trickle Charging

Power Requirements The Downloaders require one power outlet. The Downloader and Downloader/
Recharger must be used with the AC power supply adapter supplied with
them. The Downloader and Downloader/Recharger have different power
supply adapters that are not interchangeable. The Downloaders are capable
of supplying power to the portable printer which reduces the number of power
outlets required in the downloading and printing area.

DR Affect on The operating temperature for an i-STAT 1 Analyzer is 18°C to 30°C. The DR
Ambient Operating and Rechargeable Battery may raise the temperature of the i-STAT 1 Analyzer
Temperature Range 2°C-3°C relative to the ambient temperature if:

• The Analyzer is frequently lifted and replaced into the DR

• Multiple thermally controlled cartridges are run in the Analyzer
while it is in the DR.

Programming and Details for programming the Network Downloaders can be found in the
Connections Downloader Programming and Wiring section of this manual. Diagrams and
instructions for connecting peripheral components to the Downloader can also
be found in the Downloader Programming and Wiring section.

Cautions Do not place metal objects on or near the

exposed gold charging contacts.

Be sure to install all cables and power supplies

so they do not pose a trip hazard. Mount
equipment so cables and accessories stay clear
of walkways. The AC power supply adapter plug
acts as the disconnect device for the Downloader
and Downloader/Recharger and, therefore, the
socket outlet must be installed (or located) near
the Downloader or Downloader/Recharger and
must be easily accessible.

Non i-STAT provided equipment connected to

the network downloader's DB9 port must be
isolated from earth ground.

Art: 714368-01D Rev. Date: 04/04/04 6-3

Transmitting Data To transmit through a Downloader to the Data Manager, place the analyzer
from Downloader to between the arms on the front of the Downloader with the test strip port end
the Data Manager touching the Downloader. When properly aligned the red proximity light will
turn on and the analyzer will automatically transmit (upload) all unsent results.
(The analyzer does not need to be turned on.) Do not move the analyzer while
the message “Communication in Progress” is displayed on the screen.

Transmitting Data To transmit data through a Downloader/Recharger, place the analyzer in the
from Downloader Downloader/Recharger’s cradle. When properly aligned, the blue proximity
/ Recharger to the light will turn on and the analyzer will automatically transmit (upload) all
Data Manager unsent results. (The analyzer does not need to be turned on.) Do not move
the analyzer while the message “Communication in Progress” is displayed on
the screen.

Transmitted The following information is transmitted from the analyzer with each test
Information record:

² The date and time the test was performed

² Operator ID and Patient ID or Quality Test fluid lot
number
² All information entered by the operator, such as lot
numbers, sample type and comment codes
² Result(s)
² Serial number of the analyzer
² Uses count of the analyzer
² Application software version in the analyzer
² Standardization software in the analyzer

6-4 Art: 714368-01D Rev. Date: 04/04/04

Troubleshooting The analyzer displays “Waiting to Send” until communication is established
with the Central Data Station. When communication is established the message
changes to “Communication in Progress” and the arrows circle until upload
is complete. If the message does not change from “Waiting to Send” or if the
Analyzer Status screen reports unsent results after the upload, refer to Support
Services in the Troubleshooting section.

Charge Battery Put new rechargeable battery in external charging bay on the i-STAT®1
Before Use Downloader/Recharger for 40 hours. Battery will be 100% charged and ready
for use. Analyzer with disposable batteries may be placed on Downloader/
Recharger to download data until rechargeable battery is ready.

Keep Battery Fully charged battery, if not periodically recharged, will self-discharge in
Charged approximately three months. Prevent self-discharge by either (1) keeping the
rechargeable battery in an Analyzer that is periodically on the Downloader/
Recharger, or (2) store the rechargeable battery separately in the external
charging bay on the Downloader/Recharger.

Rechargeable Rechargeable batteries normally exhibit reduced charge capacity after a

Battery Life reasonable lifetime or number of discharge-recharge cycles. i-STAT rechargeable
batteries come with a service life expectancy of 15 months from the date of
manufacture which appears on the battery. While the battery may last longer
in your application, you may need to purchase a new rechargeable battery to
replace a failing battery after the 15 month lifetime.

Charging the Placing an analyzer in a Downloader/Recharger will automatically initiate

Rechargeable recharging of the rechargeable battery. The indicator light on top of the
Battery Downloader/Recharger will be green (trickle charge), red (fast charge), or
blinking red (fast charge pending) when an analyzer with a rechargeable battery
is placed in the Downloader/Recharger.

No damage will be caused if an analyzer with disposable batteries installed is

placed in the Downloader/Recharger.

Art: 714368-01D Rev. Date: 04/04/04 6-5

Charging Placing a rechargeable battery into the recharging compartment will automatically
Rechargeable initiate trickle recharging. The indicator light near the recharging compartment
Battery in will be green when a rechargeable battery is placed in the compartment.
External Recharge
Compartment
STEP ACTION

1 The battery pack has two labels: one for orientation in the analyzer
and one for orientation in the Downloader/Recharger. With the
label with the Downloader facing up and the electrical contact
end of the pack facing the contacts in the battery compartment,
insert the pack into the compartment as shown on the label.
2 To remove the battery after it is charged, back the pack out of the
compartment.

Full recharge from a discharged state takes approximately 40 hours.

Caution If you are using rechargeable batteries, use only rechargeable batteries and
recharging equipment supplied by your i-STAT distributor. Other batteries
and rechargers may affect test results and pose other hazards to operators and
patients. A falling instrument may cause injury. Place the instrument on a flat
and stable surface at all times to ensure the instrument does not fall.

6-6 Art: 714368-01D Rev. Date: 04/04/04

 PORTABLE PRINTER 7
MARTEL PRINTER

Overview The Martel Thermal portable printer can be used in the testing area. The printer
can receive data directly from the analyzer via IR transmission or through a data
cable connected to a Downloader. The printer can be recharged from a power
adapter connected to an outlet.

Specifications Dimensions Height: 64mm

Width: 135mm
Depth: 130mm
Weight 425g (Approx.)
Power 1. 4.8V Nickle Metal Hydride battery pack.
2. Power adapter for AC outlet
3. Downloader
Communication Link 1. Infra-red
2. RJ12
Paper 5.7cm thermal
Switch On/Off
LED Indicator Lights POWER: Green
STATUS: Amber
Printing method Thermal line printing
Printing speed 10 lines per second
Temperature Operating: 0 °C to 50 °C (32-122°F)
Storage: -20 °C to 60 °C (-4-140°F)
Charging: 10 °C to 45 °C (50-113°F)

or
n ect ch
on Swit
e rC ff ED
Paper Cup Po
w
n /O I RL
O

Side view of Martel

Printer

r
ecto
Paper Outlet nn
2 Co
RJ1

Top view of Martel Printer

Back view of Martel
Printer
Art: 714369-01C Rev. Date: 04/04/04
Supplies Provided  Adapter and power cord
with Printer
 One roll of paper

Power The printer is turned on using the switch on its left side. When the printer is
on, the Power LED will be green. The plug for the AC adaptor is also on the
left side.

For printer serial numbers below 240223657, the rechargeable battery is trickle
charged when the printer is turned on or off and connected to an AC outlet.
Before putting these serial number printers into use, the printer should be
turned off and the battery charged for 16 hours.

For printer serial numbers above 240223657, the power LED may flicker when
connected to the power supply and the switch is in the OFF position. This flicker
indicates that the printer is fast charging. Fast charging occurs only when the
printer is turned off. Trickle charging occurs when these printers are plugged
in and turned on, but not in use. Printers above serial number 240223657
indicating low battery will charge to full capacity in 9 hours, if charged from a
12V supply with the power switch off.

The battery needs to be recharged for all printer serial numbers when the Status
LED lights continuously during printing. If the battery becomes exhausted,
printing will become faint, erratic, or not possible at all. Should this happen,
turn the printer off and allow to recharge for 1 hour before attempting printing
again

Paper Paper may be ordered along with other supplies for the i-STAT System or paper
with the following specifications can be used:

 Black print thermal paper

 2.25” (5.7 cm) wide by 80’ (25 m) long
 Paper grade: TF50KS-E2C
The Status light will flash to indicate that the paper has run out.

To replace the paper, open the paper cup lid by squeezing the lid as shown in
the illustration and remove any remaining paper by pressing the Paper Feed
button. Do not pull paper through the printer mechanism. Reel off a few
centimeters from a new roll of paper and check that the end has clean straight
edge. Slide the leading edge of the paper through the paper entry slot, with the
leading edge of the paper feeding forwards from the bottom of the roll, until
you feel resistance. Press the paper feed button and feed the paper through the
printer mechanism. Keep the paper feed button depressed until enough paper
is fed through the printer mechanism to pass through the paper exit slot. Sit
the new paper roll in the paper cup and close the lid.

Should the paper become creased or out of line when feeding a new roll, cut the
end off the paper roll, feed out the creased paper using the Paper Feed button,
and reload ensuring the paper has a clear straight edge.

Before use, open the paper cup lid and ensure that the paper roll is present.
Close the lid, ensuring that the paper passes through the paper exit slot. Turn
the printer on. The Power indicator will light and the printer mechanism will
reset.

7-2 Art: 714369-01C Rev. Date: 04/04/04

Position of paper roll in printer

 Squeeze cup lid to gain
access to paper roll

Paper

Position of paper roll in printer

When removing a printout from the printer, pull the printout toward the front
of the printer and tear from one side to the other across the serrated edge.

Serrated Edge
Paper
Using serrated edge
to tear paper

Printing Directly Before printing ensure that the printer is turned on. The printer is turned on
from the Analyzer and off using a switch on the left side of the printer. When the printer is on
the Power LED will be green.

To print directly from the analyzer, point the analyzer’s Infrared Communication
Window at the printer’s IR LED window on its left side, ensure that the results
to be printed are displayed, and press the Print key on the analyzer. The printer
must be within 1 to 5in. (2.5 to 12.7cm) of the analyzer and must not be too
close to the analyzer. Do not move the analyzer or printer until printing is
complete.

Printing Via a See the Downloader Wiring and Programming section of this manual for
Downloader directions to connect the printer to a Downloader or Downloader/Recharger.
Before printing ensure that the printer is turned on. The printer is turned on
and off using a switch on the left side of the printer. When the printer is on
the Power LED will be green.

Place the analyzer between the arms of the Downloader or in the Downloader/
Recharger, ensure that the results to be printed are displayed, and press the Print
key. Do not move the analyzer or printer until printing is complete.

Art: 714369-01C Rev. Date: 04/04/04 7-3

Printing Many Select 2 – Data Review from the Administration Menu on the analyzer, then
Results select 7 – List. Use the arrow keys to page up and down through the pages of
stored results. Press the numbered key for each test record to be printed. To
deselect a record, press that numbered key again. When all test records have
been selected, align the printer and analyzer according to the directions under
Printing Directly from an Analyzer or place the printer in a Downloader or
Downloader/Recharger according to the directions above, and press the Print
key.

What is Printed Name of Test i-STAT cartridge type or PCx Glucose Strip
Sample ID Patient ID or type of quality test and lot
number of solution tested
Results Results are printed with units as well as
flags and comment codes if applicable.
At Patient Temperature If the patient’s temperature was entered
on the Chart Page, a second set of results
is displayed for blood gases at the patient’s
temperature.
Sample Type Sample type selected from Chart Page
when sample is patient or proficiency test
Free Fields Information entered into the free fields on
the Chart Page when sample is patient or
proficiency test
Time and Date Time and Date when test was performed
Operator ID Operator ID
Lot Number Lot number of cartridge or test strip if
applicable
Serial Serial number of the analyzer
Version Analyzer application software
CLEW Standardization software

Caution  Use power supply provided with printer.

 Do not operate the printer without paper.
 Do not allow the power supply to become a trip hazard.
 Do not disturb the analyzer or printer until printing is complete since
this will interrupt the printout. If printing is interrupted, realign the
printer and analyzer or replace the analyzer in the Downloader to resume
printing. Note: If significant time has elapsed, some results may be
missing from the printout. Reprint the results.
 If printed results appear inconsistent with a patient’s clinical assessment,
verify that the printed results match the data in the analyzer. If the
results do match, the patient sample should be retested using another
cartridge. If they do not match, reprint the results. If the reprint still
does not match the analyzer data, the printer requires service and the
printed results must not be used.

7-4 Art: 714369-01C Rev. Date: 04/04/04

Troubleshooting Printer not printing. Power LED on and Status LED off:
 check that results are displayed or that results have been selected from
List under Data Review.
 check that that distance between analyzer and printer, if printing
directly from the analyzer, is not too short or too long.
 perform printer self test to ensure that printer is functioning. Turn the
printer on while pressing the Paper Feed button, then release the Paper
Feed button and ensure that the printout is clear.

Paper is feeding but nothing is printed: check that the paper is feeding from
under the roll.

Printer not printing and Status light on continuously: battery needs to be

recharged.

Printer Power LED does not come on when printer turned on: battery needs
to be recharged. The power adapter cannot supply sufficient for printing so
the battery needs to be partially charged before printing is possible.

Printer not printing and Status light flashing at rate of 0.5 seconds: printer is
out of paper.

Printer not printing and Status light flashing at rate of 0.25 seconds: print head
temperature too hot. Printing will be suspended until print head temperature
returns to normal level.

Art: 714369-01C Rev. Date: 04/04/04 7-5

 DATA MANAGEMENT 8
Introduction The i-STAT System provides comprehensive data management capabilities
to ensure that blood analysis results obtained at the patient bedside can be
integrated into the hospital’s various information systems. The Data Manager
computer system is capable of receiving simultaneous transmissions from several
different types of blood analysis instruments. The instruments may include,
but are not limited to:

q i-STAT Portable Clinical Analyzer (PCA)

q I-STAT-1 Analyzer
q AccuData GTS
q Phillips Blood Analysis Module via the Clinical Data Server

This section describes the information management capabilities of the i-STAT

System and how the components can be integrated to meet the needs of point-
of-care data management.

Components The i-STAT 1 Analyzer

With each cartridge use, the analyzer allows entry of:

q operator identification number

q patient identification number
q proficiency identification number
q simulator serial number
q cartridge lot number
q glucose strip lot number (if applicable)
q control lot number
q calibration verification lot number
q comment codes for patient and control results
q chart page information
• sample type
• patient temperature
• FIO2
• free fields: three fields, up to 9 characters each

Art: 714370-01C Rev. Date: 12/15/03 8-1

 The Portable Clinical Analyzer
With each cartridge use, the analyzer allows entry of:

q operator identification number

q patient identification number
q chart page information
• patient temperature
• FIO2
• free fields: three fields, up to 6 characters each
• sample type
The analyzer electronically attaches its serial number, the test date, and test
time to the results.

The Data Manager A validated and qualified Data Manager computer system may be purchased
from i-STAT Corporation for use with the Central Data Station 5 software
application. The end user also has the option to purchase the computer
system from another hardware vendor. In those cases, i-STAT Corporation
will provide a minimum requirement specification to ensure proper operation
and functionality of the Central Data Station 5 software application.

i-STAT Corporation and its distributors can supply the following hardware:
• i-STAT Data Manager computer system and its peripherals
• IR Downloader (Serial and Network) and required components
• IR Link and required components

i-STAT Central Data This is i-STAT’s primary data management application. It supports all blood
Station Version 5 analysis instruments mentioned above via a combination of serial and/or
Software network communications.

Please see the “Central Data Station 5” section of this System Manual for
additional information on installation, setup, and configuration of this
application.
Data downloaded from the i-STAT 1 Analyzers can be viewed in separate Data
Viewers for Results, QC Codes, Simulator, Unsent Records, Control Results,
Calibration Verification Results, and Proficiency Results (external quality
control).
Note: All data (regardless of type) downloaded from the Portable Clinical
Analyzer and the Philips Blood Analysis Module will only appear in
the Results Data Viewer.

Additional features include the ability to:

q view patient and quality results by patient identification number,

operator identification number, date/time chronological order,
location, department, or analyzer serial number.
q edit identification numbers associated with results (original numbers
are automatically retained for reference)
q add comments to records
q send results (automatically or by manual selection) to another
information system such as an LIS or HIS

8-2 Art: 714370-01C Rev. Date: 12/15/03

 q archive records
q export records to ASCII text files
q manage instruments
q manage operators
q manage inventory
q manage policy exceptions
q monitor operator competence
q monitor LIS entry exceptions
q monitor download compliance

Downloader and The Downloader and Downloader/Recharger are available for use with ethernet
Downloader/ cabling (network format) and direct wiring (serial format). The Network
Recharger Downloaders convert serial data transmitted from the i-STAT 1 Analyzer via
infrared transmission to TCP/IP, which then delivers the data to the Data
Manager using the hospital’s ethernet system.

Through a customizable feature, transmissions can be performed automatically

when an analyzer is placed in the Downloader or Downloader/Recharger.

Please contact your i-STAT Support Representative for additional information

related to specifications and configuration requirements for your facility.

IR Link A Portable Clinical Analyzer communicates to the Data Manager via an Infrared
Interface Link (IR Link). The IR Link converts infrared signals received from the
analyzer to electronic signals, and passes them to the Data Manager. To transmit
results, place an analyzer in the IR Link and press the star (*) key. A single IR
Link can be used to collect results from a limitless number of Portable Clinical
Analyzers, one at a time. Transmission time is usually less than 15 seconds.

LIS/HIS Interface The Data Manager typically connects to the Laboratory or Hospital Information
System. The user can manually select records to send or the Central Data
Station application can be configured to automatically transmit records to the
alternate system as they are received. There are four data transmission protocols
available:

q AME (US only): this protocol is used to simulate manual keystrokes

when connected to a hospital’s LIS or HIS. This protocol is installed
and configured only by i-STAT Interface Operations department.
q ASTM: Data transmission conforms to ASTM E1381-95 and E1394-97
standards. Specifications for this protocol can be obtained from your
i-STAT Support Representative.
q HL7: This is a robust Electronic Data Interchange (EDI) interface.
Data transmission conforms to HL7 v2.4 and is based upon the
CIC observation Reporting Interface distributed by the National
Committee for Clinical Laboratory Science (NCCLS) in the US
under Document POCT-1-A. An activation key is required to use this
protocol. Contact your i-STAT Support Representative to obtain this
license key. This interface requires a receiver software from the LIS
vendor.

q Data File: Formats the CDS file for third party use.

Art: 714370-01C Rev. Date: 12/15/03 8-3

Standard Data The figure below shows the standard i-STAT Data Management configuration.
Management Downloaders, Downloader/Rechargers, and IR Links are placed in end-user
Configuration departments and allow handheld analyzers to transmit results to the Data
Manager. The results from the Philip Medical Systems Blood Analysis Module
can also be interfaced via the Philips Clinical Data Server. The Data Manager
then interfaces to the LIS/HIS.

Connecting There is only one option available for physically connecting remote Downloaders,
Components Downloader/Rechargers, and IR Links to a Data Manager. That option is:

q Ethernet Connection

The i-STAT System connects terminal servers to Ethernet ports to

allow a Local Area Network (LAN) or Wide Area Network (WAN) to
transport data from a Downloader, Downloader/Recharger, or IR Link
to the Data Manager using the TCP/IP protocol. Often, no additional
wiring needs to be installed, but network ports or ‘drops’ may need to
be installed in walls at appropriate locations. Also, power outlets will
need to be available at each location in order to provide power to the
Downloaders, Downloader/Rechargers or terminal servers. Using this
method allows an unlimited number of Downloaders, Downloader/
Rechargers, and IR Links to be connected to the Data Manager.

8-4 Art: 714370-01C Rev. Date: 12/15/03

 CUSTOMIZATION 9
Overview This section describes the parameters that can be customized for site-specific
testing requirements and the factory default settings. For the procedure to
customize using the Central Data Station see the Central Data Station section
of this manual. For the procedure to customize the analyzer directly through
the keypad, see Customization in the i-STAT 1 Analyzer section of the manual.
A customization profile consists of selections made from four major windows:
Language, Unit Set, CLEW and Preferences. The Preferences Window consists
of six additional windows: Instrument, ID Entry, Test, QC, Results and Strip
Lots.
Caution Analyzers that have been repaired and returned or replaced will have the
factory settings as indicated by the DEFAULT0 customization profile name on
the Customization screen (under the Administration Menu) of the analyzer.
These analyzers must be customized, if applicable, before being put into use.
These analyzers will also have the current standard CLEW and application
software (JAMS). If a different version of CLEW or application software is in
use, it must be downloaded to these analyzers.
If location specific customization profiles are created, analyzers should not
be moved from one location to another unless they are re-customized for the
new location. This is especially important if “CPB: Automatically Adjust” or
“CPB: Do Not Adjust” is included in a location-based customization profile.
The CPB function adjusts hematocrit and hemoglobin results for the dilutional
affect of pump fluid during cardiopulmonary bypass surgery. If an analyzer
customized for the CVOR as “CPB: Automatically Adjust” is used for patients
who are not on the pump, hematocrit results will be reported falsely high. If
an analyzer customized as “CPB: Do Not Adjust” is used for patients who are
on the pump, hematocrit results will be reported falsely low. For details on
the CPB function, see the Theory section of this manual.
Art: 714371-01C Rev. Date: 07/12/04 9-1
 ANALYZER CUSTOMIZATION OPTIONS AND DEFAULT SETTINGS
9-2

Option Description Default Comments

LANGUAGE WINDOW Language for text: English, Japanese, German, Italian, Dutch, English Russian can be dowloaded only to the Portable Clinical
Spanish, French, Swedish, Russian, Portuguese, Danish, and Analyzer. Portuguese, Danish, and Finnish can be dowloaded
Finnish only to the i-STAT 1 Analyzer.
UNIT SET WINDOW Reporting units for results. Selected from predefined sets or Unit Set 00 See table below with 17 predefined unit sets. Unit Set
by analyte. 99 allows the name and units for each test to be defined
individually.
Note: Reference Ranges and Action Ranges in the Preferences
Window must be changed when changing units.
Art: 714371-01C

CLEW WINDOW Standardization data. All non-expired versions listed. CLEW in analyzer when The CLEW software has an expiration date. If an expired CLEW
shipped. remains in a customization profile, a warning will
be displayed.
PREFERENCES Options and default settings are listed under six headings:
WINDOW Instrument, ID Entry, Test, QC, Results, Strip Lots.
USE OPERATOR LIST 4000 operator IDs can be stored in the analyzer along with Not enabled (no Operator lists are created in the Operator Workspace on the
certification start and end dates for both glucose test strip and information stored) Central Data Station. This check box cannot be enabled if
cartridge testing. the Operator List is empty in the Operator Workspace for all
Departments (other than the one labeld "Unassigned").
Rev. Date: 07/12/04
 PREFERENCE WINDOW: FOR INSTRUMENT OPTIONS

Option Description Default Comments

PASSWORD 0-5 digit password to access Set Clock, the Change function No password Password protection for the Set Clock function can be enabled
Art: 714371-01C

in Customization, and Utility under the Administration menu. or disabled. See below.
DATE FORMAT mm/dd/yy or dd/mm/yy mm/dd/yy For Clock Set function only.
INACTIVITY TIMEOUT Number of seconds after a result is displayed and no operator 120 seconds
intervention that an analyzer will turn off. Allowable range is
45 to 1620 seconds.
SOUND If enabled, the analyzer will emit a beep after each successful Beep enabled If Sound is disabled, the analyzer will only beep when a
key press, when results are ready or when a Quality Check sample is accepted during glucose test strip testing and after a
message is displayed. successful barcode entry.
AUTO TRANSMIT Analyzer transmits results when placed in Downloader or Enabled
Downloader/Recharger.

MEMORY FULL ACTION Not enabled: over-write the oldest record without warning. Not enabled Memory Full refers to when the unsent records as recorded on
Enabled: Warn user (start-up warning) or Lockout (testing the Analyzer Status screen reaches 5000. Uploading does not
disabled until upload occurs). erase the data from the analyzer’s memory.
Rev. Date: 07/12/04

BATCH MODE TIMEOUT Not active at this time.

DISPLAY PASSWORD The default setting is enabled. However it may be useful to Enabled
FOR CLOCK PAGE disable password protection for the clock page in the Spring
and Fall when clocks are set forward and backward one hour.
ENABLE PCX GLUCOSE Enables the PCx glucose test strip reader on the i-STAT1 Not Enabled When glucose test strip testing is disabled, the analyzer does
Analyzer. not display any options for the PCx Glucose Test Strip.
SYNCHRONIZE Will synchronize or update the real time clock in the i-STAT1 Not Enabled This eliminates the need to reset the analyzer's clock at the
CLOCK TO CDS Analyzer to the Central Data Station's clock at the time of each beginning and end of Daylight Savings Time.
download.
APPLY OPERATOR LIST Requires operator to enter their operator ID number to access Not Enabled This option can help a facility comply with patient privacy
TO VIEWING STORED stored patient results on the i-STAT1 analyzer. regulations.
PATIENT RECORDS
LIMIT NUMBER OF Allows the user to apply a date range limit to the Transmit All Not Enabled This will prevent operators from sending older patient records
RECORDS IN TRANSMIT function in the i-STAT1 Analyzer that may have already been deleted from the Central Data
ALL Station.
UPLOAD SCHEDULE Options are Off, or every X hours, where X can be 1 to 65535 Off: no warning or If no upload schedule is specified and the Memory Full warning
hours. If enabled, the behavior of the analyzer if the schedule lockout. is ignored and Auto-transmit disabled, data will eventually be
is not met can be specified. Behavior Options are: Warn User overwritten. However, if an analyzer has not been used and the
(start-up warning message) or Lockout (testing disabled until upload interval is exceeded, this analyzer will be inoperable if
9-3

upload occurs). the lockout option is used.

 PREFERENCE WINDOW: FOR OPERATOR AND PATIENT ID OPTIONS
9-4

Option Description Default Comments

OPERATOR ID Minimum and maximum allowed operator ID length (scanned Min = 0 Max = 15 If operator IDs are a fixed length, the min. and max. settings
or manually entered) should both be equal to the ID length.
REPEAT ID ENTRY Operator must enter ID twice. Analyzer prompts operator to Enabled: repeat required This option can be set for manual and/or scanned ID Entry.
start again if IDs do not match.
INCLUDE ID ON Enables/Disables printing of operator IDs on printouts from Enabled Disabling the printing of operator IDs can prevent uncertified
PRINTOUT the Martel printer. operators from learning the IDs of certified operators.
BARCODE OPTIONS The type of barcodes used for Operator ID. See table below. All barcode types

MANUAL ENTRY CHECK Options are None, ISBN Modulus 11 Check, and IBM None Check digit algorithms are given in HL7 Specification, Section
DIGIT Modulus 10 Check. 2.9.5.3
INVALID OPERATOR Behavior of analyzer when Operator ID not in stored list or Continue without This option should not be enabled if the Use Operator List
Art: 714371-01C

certification date expired Options are: Not enabled (continue warning option is disabled.
without warning), Warn User (prompt to continue), and Separate Actions can be chosen for Certification Expired or
Lockout (block testing until a valid Operator ID is scanned/ Operator Not On List.
entered).
PATIENT ID Minimum and maximum allowed patient ID length (scanned Min = 0 Max = 15 If ID numbers are a fixed length, the min. and max. settings
or manually entered) should both be equal to the ID length.
REPEAT ID ENTRY Operator must enter patient ID twice. Analyzer prompts Repeat ID enabled This option can be set for manual and/or scanned ID entry.
operator to start again if IDs do not match.
PATIENT ID RECALL Operator can recall last patient ID when analyzer prompts for Enabled The most recent patient ID is recalled by pressing the → key.
Patient ID.
BARCODE OPTIONS The type of barcodes used for Patient ID. See table below. All barcode types

MANUAL ENTRY CHECK Options are None, ISBN Modulus 11 Check, and IBM None Check digit algorithms are given in HL7 Specification, Section
DIGIT Modulus 10 Check. 2.9.5.3
Rev. Date: 07/12/04
 PREFERENCE WINDOW: FOR TEST OPTIONS

Option Description Default Comments

Art: 714371-01C

AUTO-CHART If enabled, the Chart page will be displayed automatically. Selected Not enabled: operator must If any information on the Chart page is mandatory for the site, Auto-
PRESENTATION separately for cartridge and test strip tests. press the → key to display Chart Presentation is recommended.
the Chart page.
CARTRIDGE PATIENT TEST Require information before running cartridge: Operator will be Not enabled This option is referred to as “Information First” in the Procedure for
required to enter Operator and Patient IDs before the analyzer will Cartridge Testing section.
initiate a cartridge test cycle. When not enabled, the operator can insert a cartridge and the test cycle
Enter Lot Number: Adds a Cartridge Lot Number prompt to the will initiate. Information is then entered during the test cycle.
cartridge test cycle. If the option above is enabled along with this Cartridge lot numbers are mandatory prompts for tests performed
option, the operator will be required to enter the cartridge lot number under Quality Tests.
before the analyzer will initiate a patient test cycle.
The Scan Cartridge Barcode option is required for i-STAT's
Scan Cartridge Barcode: requires the user to scan the cartridge Lot immunoassays.
number barcode before entering an operator and patient ID after a
cartridge has been inserted into an i-STAT1 Analyzer.
Third Party Result Output and Require Analyzers to be in
Downloader: These two options were instituted in preparation for the
future release of a new data integration option and SHOULD NOT be
Rev. Date: 07/12/04

activated by users at this time. Misconfiguring your analyzers using

these new features can cause testing to be disabled.
PATIENT TEST COMMENT Options are: No prompt Care should be taken to select combinations that make sense.
CODE No prompt or prompt as follows: In the case of a missed required Comment Code, the results will be
stored and “_ _ _” will be entered as the Comment Code.
• Prompt for Comment Code, All Results in Range (action
range). Comment Code can be optional (Allow no Comment) or
mandatory (Require Comment).
• Prompt for Comment Code, Any Result out of Range (action
range). Comment Code can be optional (Allow no Comment) or
mandatory (Require Comment).
• A comment code of up to 3 characters is allowed.
SAMPLE TYPES FOR Drop down menus for each sample type allow the six sample types 1-ART 4-CAP The sample type is stored with the test record and is included on the
CARTRIDGE to be re-ordered or changed. Up to 4 user definable characters are 2-VEN 5-CORD printout from the portable printer and in the record in the Central Data
allowed for each sample type. 3-MIX 6-OTHR Station.
CHART FIELDS Any item on the Chart Page can be deleted by clicking off the check All items set to not
mark in the Display column or be made mandatory by clicking mandatory.
a check mark in the Mandatory column. If any item is set as
mandatory, the Chart Page will be displayed automatically after
the Patient ID is entered. The items on the Chart page can also be
rearranged by holding down the left mouse button and dragging the
item to another location.
9-5

TEST STRIP PROMPT FOR Options are: Prompt operator to choose between Art/Cap or Venous Prompt
SAMPLE TYPE sample types or no prompt with either Art/Cap or Venous as the
default sample type.
 PREFERENCE WINDOW: FOR QUALITY CONTROL OPTIONS – CARTRIDGE
9-6

Option Description Default Comments

EXTERNAL SIMULATOR Options are Off (no prompt), an interval of specified hours (1 No prompt For the quality control of i-STAT analyzers, i-STAT recommends
SCHEDULE to 65535 hours), and an interval of specified patient tests (up the use of the Electronic Simulator.
to 99999). i-STAT’s recommendation for the frequency of the Electronic
INTERNAL SIMULATOR Time interval when the internal Electronic Simulator test Interval 24 hours. Simulator is once every 24 hours. More frequent use or
SCHEDULE will be run. Options are Off; an interval of specified hours Lockout use according to number of patient tests may be required by
(1 to 65535 hours); 8/24 (every 8 hours for blood gases, accreditation and regulatory bodies.
coagulation, hematocrit and immunoassays, and every 24
hours for other tests); an interval of specified patient tests (up
to 99999).
The behavior of the analyzer if the simulator test fails can also
be specified. If the Schedule Option Lockout is selected, the
analyzer will continue to perform the simulator test and will
Art: 714371-01C

continue to display “FAIL” on subsequent cartridges until the

test passes. If Lockout is not selected, the simulator test will
not be initiated again until next scheduled time.

PREFERENCE WINDOW: FOR QUALITY CONTROL OPTIONS – TEST STRIP

Option Description Default Comments

STRIP CONTROL Schedule options are: Off, Every X hours (1 to 65535 Off
SCHEDULE hours), Every X Patient Tests (0 to 255 tests), and up to three
predetermined times daily
The behavior of the analyzer if the schedule is not met can
also be specified. Options are: Warn (start-up warning) or
Lockout (disable test strip testing until QC run).
Rev. Date: 07/12/04

STRIP CONTROL TEST Prompt or no prompt for Normal/(Mid)Level Control. No prompt for Normal/ If selected, the prompt for the Normal Level control will come
SETTINGS Comment Code when a value is in-range. Options are: (Mid) Level Control and after the prompt for the Low Level control.
Disabled (no prompt for comment code), Allow no Comment no prompt for Comment
(Comment Code optional), Require Comment. Code.

Comment Code when value is out of range. Options are:

disabled (no prompt for Comment Code), Allow no Comment
(Comment Code optional), Require Comment.
A Comment Code of 3 characters is allowed.
 PREFERENCE WINDOW: FOR RESULTS REPORTING OPTIONS
Art: 714371-01C

Option Description Default Comments

ANALYTE ENABLED Tests can be disabled. If disabled, the test will not appear in the All tests enabled.
Operator Test Selection list or on the results page and test results will
not be stored.
REFERENCE RANGES Reference ranges can be defined for each test. The ranges will be Ranges listed in the Ranges will be displayed on the Customization screen of the analyzer
depicted as tic marks on the bar graphs on the result pages. There Cartridge and Test under the Administration Menu.
are no bar graphs for blood gas, coagulation, and immunoassay Information sheets and the Only one range is allowed for each test in a particular analyzer.
tests. Precision PCx and PCx However, different customization profiles can be set up in specific
Plus Glucose Test Strip analyzers used for specific patient populations.
package insert.
Care should be taken to enter the same units as selected in
the Unit Set Window.
ACTION RANGES High and low action ranges can be defined for each test Disabled Care should be taken to enter Action Ranges within the
(-99999.9 to 99999.9). reportable ranges of the tests.
Rev. Date: 07/12/04

Care should be taken to enter the same units as selected in

the Unit Set Window.
The action ranges for glucose apply to the cartridge and the test strip.
PRINT REFERENCE Reference Ranges can be printed with results. Ranges will print only Disabled The active Preference set in the analyzer is listed as ”Custom” on the
RANGES if the record to be printed is stored with the active Preference set in Analyzer Status page and the Preference set stored with the record is
the analyzer. displayed on the Chart Page when the record is recalled and is printed
with the results.
OPERATOR TEST Requires the operator to select tests to be reported from a cartridge Disabled This option facilitates compliance with Medicare/Medicaid regulations
SELECTION test panel. in the USA.
ACT OPTIONS The user can select between the current 37° (PREWRM) result PREWRM for both cartridge Pleas see the Technical Bulleti "ACT Test Result Calibration Options:
(i-STAT 1 Analyzer Only) calibration and a new "NON-PREWARM" (ambient temperature) types. PREWARMED vs. NON-PREWARMED Result Calibration Modes for
result calibration for both Celite ACT and Kaolin ACT cartridges. the i-STAT 1 Analyzer" for full discussion.
HEMATOCRIT OPTIONS Reference anticoagulant used to calculate hematocrit result: K3EDTA K3EDTA See Theory section in this manual for explanation of CPB. Analyzers
or K2EDTA/Heparin/None. (NaEDTA is included in this option and can be customized by location.
None means no anticoagulant.)
CPB options are: Prompt or no prompt for CPB compensation when
cartridge includes hematocrit sensor, and if no prompt, automatically Prompt CPB Analyzers in CVORs can be customized to always use CPB
Adjust or Do not adjust. compensation.
DECIMAL SEPARATOR Select comma (,) or period (.) Period
9-7

BASE EXCESS Select Base Excess of Extracellular Fluid (BEecf) or Base Excess of BEecf See Cartridge and Test Information sheet for PCO2 for formula.
CALCULATION Blood (BEb).
 PREFERENCE WINDOW: FOR QUALITY CONTROL OPTIONS – TEST STRIP LOTS
9-8

Option Description Default Comments

TEST STRIP LOT Up to 5 test strip lot numbers of 14 characters each can Blank Expired test strip lots must be manually deleted on the
NUMBERS be entered. Upper and lower ranges for low, mid and high expiration date.
controls for each test strip lot can be entered. If no control values are entered, the analyzer will use the control
values programmed into the test strip lot number.
If the Customization program is enabled (active), new lot
numbers will be automatically added to the analyzer’s memory
when it is placed in a Downloader or Downloader/Recharger.
TEST STRIP LOT NOT Behavior of analyzer when a scanned/entered test strip lot is Disabled
ON LIST ACTION not on the test strip lot list.
Options are:
Disable (allow test to continue without warning); Warn (and
Art: 714371-01C

prompt to continue); Lockout (disable testing until valid test

strip lot number is scanned/entered).
Rev. Date: 07/12/04
 PREFERENCE WINDOW: FOR BARCODES
Art: 714371-01C

Option Description Default Comments

ID BARCODES * The user can select any or all of the following as valid barcode All barcode types Barcode type Code 128 will support USS 128 and UCC/EAN
formats for both the operator and patient ID: 128, but not ISBT 128.
• I2 of 5
• Code 128
• Codabar
• Code 93
• Code 39
• EAN 8, EAN 13
I2 OF 5 OPTIONS No Check Digit USS Check Digit
USS Check Digit
OPCC Check Digit
CODE 39 OPTIONS Check Digit or No Check Digit Check Digit, Full ASCII
Rev. Date: 07/12/04

Alphanumeric or Full ASCII

TRUNCATE DIGITS User can select how to truncate digits from a scanned operator No truncation The analyzer will accept up to 15 characters for operator and
and/or patient ID: patient IDs.
First: enter number of leading characters to be stripped from
the barcode.
Last: enter number of trailing characters to be stripped from
the barcode.

* Note: For fields other than Operator and Patient ID, only the default setting for the barcode type can be scanned. These are:
• Code I2 of 5 with USS Check Digit
• Code 39 Full ASCII with Check Digit
9-9
 UNIT SETS 17 PREDEFINED UNIT SETS ARE AVAILABLE IN THE UNIT SET WINDOW. THERE IS ALSO A UNIT SET 99 THAT CAN BE USED TO SELECT THE NAME
9-10

AND UNIT FOR EACH TEST. THE DEFAULT UNIT SET IS 00

RESULT 0 1 2 3 4 5 6 7 8 9 10
Na/K/Cl * mmol/L mmol/L mmol/L mmol/L mEq/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L
BUN mg/dL
Urea mmol/L mmol/L mg/dL mg/dL mg/dL mmol/L mmol/L mmol/L mmol/L mmol/L
Crea mg/dL µmol/L µmol/L mg/dL mg/dL mg/dL mg/dL µmol/L µmol/L µmol/L µmol/L
Glu mg/dL mmol/L mmol/L mmol/L mg/dL mg/dL mg/dL mmol/L mmol/L mmol/L mmol/L
Lac mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L
pH
PCO2/PO2 mmHg kPa kPa mmHg mmHg mmHg mmHg kPa mmHg mmHg kPa
Hct % % % % % % %
Hb g/dL g/L g/L g/dL g/dL g/dL g/dL mmol/L g/L g/dL g/dL
Art: 714371-01C

HCO3/BE mmol/L mmol/L mmol/L mEq/L mmol/L mmol/L mEq/L mmol/L mmol/L mmol/L mmol/L
iCa mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L
sO2 % % % % % % % % % % %

RESULT 11 12 13 14 15 16
Na/K/Cl mmol/L mmol/L mmol/L mmol/L mEq/L mmol/L * Also, TCO2 and Anion Gap, except:
BUN mg/dL mg/dL 03 TCO2 mEq/L
Urea mmol/L mmol/L mmol/L g/L 04 TCO2, BE mmol/L
06 Anion Gap, HCO3, BE mEq/L
Crea µmol/L mg/dL µmol/L µmol/L mg/dL µmol/L
Glu mmol/L mg/dL mmol/L mmol/L mg/dL g/L Note: There are no units for pH or for
hematocrit when reported as decimal
Lac mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L
fraction
pH
Note: See Cartridge and Test Information sheets
Rev. Date: 07/12/04

PCO2/PO2 kPa mmHg mmHg mmHg mmHg mmHg for ACT, PT/INR, and cTnI units.
Hct % % % % %
Hb g/dL g/dL g/dL mmol/L g/dL g/dL
HCO3/BE mmol/L mmol/L mmol/L mmol/L mEq/L mmol/L
iCa mg/dL mg/dL mmol/L mmol/L mEq/L mmol/L
sO2 % % % % % %
 SAMPLE COLLECTION 10
SPECIMEN COLLECTION
Overview The specimen used to fill a cartridge or apply to a test strip must be collected
and handled properly to ensure that the results represent the patient’s current
status.

Only fresh whole blood samples are recommended for use with the i-STAT
System.

Specimens should be collected according to the facility’s policies and procedures.

The following precautions (taken from the references at the conclusion of this
section) can help avoid potential sources of error prior to filling a cartridge or
applying sample to a test strip.

VENIPUNCTURE - GENERAL
Overview Venipunctures are typically performed for:

 acid-base balance
 electrolyte studies
 metabolic studies
 coagulation studies
 hematologic studies

Observe the following precautions:

I.V. Line Avoid drawing from an arm with an I.V. line. I.V. solutions will dilute the
sample and may interfere with the tests.

Tourniquet Venous stasis (prolonged tourniquet application) and forearm exercise may
increase ionized calcium due to a decrease in pH caused by localized production
of lactic acid..

If a tourniquet is applied for more than one minute while looking for a vein,
release and reapply after two to three minutes.

Allow the tourniquet to remain in place until all blood is withdrawn to prevent
changes in ionized calcium and pH results.

Muscle Activity Avoid extra muscle activity, such as clenching and unclenching the fist, which
may increase potassium results.

Hemolysis Avoid hemolysis (bursting of red cells) by

 allowing residual alcohol to dry over the puncture site
 discarding a sample from a traumatic draw.
Hemolysis will cause an increase in potassium results and a decrease in
calcium results. For cTnI cartridges, gross hemolysis can also cause a
decreased alkaline phosphatase activity, resulting in decreased detection
of cTnI.

Art: 714372-01C Rev. Date: 07/12/04 10-1

Tube Order Collect blood collection tubes in the prescribed sequence to avoid
interference due to carry-over of additive from one tube to the next:
 No additive
 Citrate
 Heparin
 EDTA - Na2, K3 or K2
 Oxalate, fluoride, iodoacetate
If a citrate tube is drawn, draw a 5mL plain discard tube before drawing
the heparin tube.

VENIPUNCTURE - pH, PCO2, ELECTROLYTE, CHEMISTRY, AND HEMATOCRIT TESTS

Anticoagulants If the sample can be tested in a cartridge immediately, a plain syringe can
be used. If a cartridge cannot be filled immediately the sample should be
collected in a blood collection tube with sodium heparin or lithium heparin or
a pre-heparinized syringe labeled for measurement of electrolytes and ionized
calcium (such syringes contain balanced or low-level heparin). If manually
heparinizing syringes, the heparin-to-blood ratio should not exceed 10 U
heparin per milliliter of blood. Blood collection tubes contain approximately
15 U/mL when filled to capacity.

Samples collected in EDTA anticoagulant may be used with the i-STAT Glucose
cartridge. It may be convenient to collect a single EDTA tube when testing for
glucose and glycated hemoglobin (HbA1c) simultaneously. EDTA may not
be used with any cartridge type other than the Glucose cartridge. EDTA
will cause a clinically significant error in sodium, potassium, chloride and
hematocrit results and may affect other chemistry tests. Do not use an EDTA
sample with a cartridge that includes glucose as part of a panel. Even if only
the glucose result is to be used, all results are stored in the analyzer’s memory
and, since results can be printed and transmitted to a Central Data Station,
they can become part of the patient’s permanent record.

i-STAT cTnI cartridges require the use of either:

1. heparinized whole blood or plasma samples collected in syringes or
evacuated tubes containing lithium or sodium heparin, or
2. non-heparinized whole blood samples tested within one minute of
drawing from a patient into a plastic syringe or plastic evacuated
tube containing no additives.
The use of whole blood or plasma samples containing other
anticoagulants such as EDTA, oxalate, and citrate will cause
deactivation of the alkaline phosphatase, resulting in decreased cTnI
readings.

Fill Requirements Fill blood collection tubes with and without anticoagulant and syringes with
anticoagulant to capacity. Incomplete filling of anticoagulated tubes and
syringes will cause higher heparin-to-blood ratios, which will decrease ionized
calcium results and may affect other results. Under filling blood collection tubes
with and without anticoagulant may also cause decreased PCO2 (and calculated
HCO3 and TCO2) results.

Particial-draw blood collection tubes (evacuated tubes that are adjusted to draw
less than the tube volume, e.g. a 5 mL tube with enough vacuum to draw only 3
mL), with or without anticoagulant, are not recommended for blood gas analysis

10-2 Art: 714372-01C Rev. Date: 07/12/04

 because of the potential for decreased PCO2 (and calculated HCO3 and TCO2)
results. Care must also be taken to eliminate “bubbling” of the sample with a
pipette when filling a cartridge to avoid the loss of CO2 in the blood.

Samples should not be used for cTnI testing unless the blood collection tube
is at least half full.

Mixing Gently mix blood and anticoagulant immediately to avoid clotting. Invert a
blood collection tube at least 10 times. Roll a syringe vigorously between the
palms for at least 5 seconds each in two different directions, then invert the
syringe repeatedly for at least 5 seconds, then discard the first two drops of blood.
Note that it may be difficult to properly mix a sample in a 1.0 cc syringe.

Exposure to Air Avoid exposing the sample to air when testing venous samples for ionized
calcium, pH and PCO2 . Test immediately if the sample is drawn into a blood
collection tube. Expel any air bubbles immediately if the sample is drawn into
a syringe or leave an air bubble next to the plunger and do not allow it to move
through the sample.

Time to Test For the most accurate results, test samples immediately after drawing. Samples
for lactate must be tested within 3 minutes. Samples for blood gases and ionized
calcium should be tested within 10 minutes. Other analytes should be tested
within 30 minutes.

If testing is not immediate, remix blood collection tubes by gentle inversion

at least 10 times. Roll syringes between the palms for at least 5 seconds each
in two different directions, then invert the syringe repeatedly for at least 5
seconds, and then discard the first two drops of blood. Blood in the tip of the
syringe may have been exposed to air and may not be homogenous with the
sample in the barrel of the syringe. Note It may be difficult to properly remix
a sample in a 1.0 cc syringe

VENIPUNCTURE - COAGULATION TESTS

Blood Flow Collection technique resulting in good blood flow must be used. Inadequate
blood flow may produce erroneous results.

Plastic The sample for testing should be drawn into a plastic collection device (syringe
or blood collection tube) containing no anticoagulant, clot activators, or
serum/plasma separators. Any transfer device (dispenser, capillary tube,
pipette or syringe) must be plastic and must not contain anticoagulant.

Samples collected into glass tubes or syringes, or in tubes containing

anticoagulants, activators, or separators cannot be used with the i-STAT
coagulation cartridges.

Note: NCCLS guidelines recommend that the sample for coagulation testing
be the second or third tube drawn when using a blood collection system
(use a discard tube if this is the only sample being drawn) or be taken
from the second syringe if a double syringe technique is used for drawing
blood.

Time to Test The sample must be immediately dispensed into the sample well of the cartridge
and the cartridge must be inserted immediately into an analyzer.

Repeat Test If a repeat measurement is needed, a fresh sample must be obtained.

Art: 714372-01C Rev. Date: 07/12/04 10-3

VENIPUNCTURE - GLUCOSE TEST STRIP (i-STAT®1 ANALYZER)
Anticoagulant Use only fresh whole blood samples. Collect the venous blood sample in a
collection tube containing sodium heparin, lithium heparin or EDTA ensuring
that the tube is completely filled. Invert the tube with the sample several times
immediatley before removing the sample. Use a disposable transfer pipette to
obtain a sampe from the center of the collection tube.

Time to Test Apply a drop of blood directly to the target area on the test strip, covering the
entire area. Test within 30 minutes of collection.

ARTERIAL PUNCTURE - GENERAL

Overview Arterial punctures are performed to access gas exchange status.

PCO2, PO2, and pH values change with changes in ventilatory support at a rate
dependent on underlying conditions. Sample should be drawn after these
changes have stabilized.

ARTERIAL PUNCTURE - BLOOD GAS, ELECTROLYTE, CHEMISTRY, AND HEMATOCRIT TESTS

Evacuated Tubes Evacuated or other blood collection tubes are not recommended for blood gas
analysis.

Syringes and If the sample can be tested in a cartridge immediately, a plain syringe can be
Anticoagulant used.

If a cartridge cannot be filled immediately, the sample should be collected in

a pre-heparinized syringe labeled for measurement of electrolytes and ionized
calcium (such syringes contain balanced or low-level heparin).

If manually heparinizing syringes, the heparin-to-blood ratio should not exceed

10 U heparin per milliliter of blood.

Fill syringes to the recommended capacity or use the least amount of liquid
heparin anticoagulant that will prevent clotting. Under filling syringes will
cause higher heparin-to-blood ratios which will decrease ionized calcium results
due to binding. Under filling syringes with liquid heparin will also dilute the
sample causing results to be affected.

i-STAT cTnI cartridges require the use of either:

1. heparinized whole blood or plasma samples collected in syringes or
evacuated tubes containing lithium or sodium heparin, or
2. non-heparinized whole blood samples tested within one minute of
drawing from a patient into a plastic syringe or plastic evacuated
tube containing no additives.
The use of whole blood or plasma samples containing other
anticoagulants such as EDTA, oxalate, and citrate will cause
deactivation of the alkaline phosphatase, resulting in decreased cTnI
readings.

Mix Mix blood and anticoagulant by rolling between the palms for at least 5 seconds,
each in two different directions. Then invert the syringe repeatedly for at least
5 seconds. Discard the first 2 drops of blood.

Exposure to Air Avoid or remove immediately any air drawn into the syringe and maintain
anaerobic conditions.

10-4 Art: 714372-01C Rev. Date: 07/12/04

Time to Test For the most accurate results, test samples immediately after draw. Samples for
lactate must be tested within 3 minutes. Samples for blood gases and ionized
calcium should be tested within 10 minutes. Other analytes should be tested
within 30 minutes.

If testing is not immediate, remix the syringe by rolling between the palms for
5 seconds each in two different directions, then invert the syringe repeatedly
for at least 5 seconds, then discard the first two drops of blood. Blood in the
tip of the syringe may have been exposed to air and may not be homogenous
with the sample in the barrel of the syringe. Note that it may be difficult to
properly remix a sample in a 1.0 cc syringe.

Sample on Ice Fill the cartridge before icing the sample for transport. Icing will increase
the potassium and will affect oxygen levels in samples collected in plastic
syringes.

ARTERIAL PUNCTURE - COAGULATION TESTS

Blood Flow Collection technique resulting in good blood flow must be used. Inadequate
blood flow may produce erroneous results.

Plastic The sample for testing should be drawn into a plastic collection device (syringe
or blood collection tube) containing no anticoagulant.

Samples collected into glass tubes or syringes, or in tubes containing

anticoagulants, cannot be used with the i-STAT coagulation cartridges.

Note: NCCLS guidelines recommend the sample for coagulation testing be the
second or third tube drawn when using a blood collection system (use
a discard tube if this is the only sample being drawn) or be taken from
the second syringe if a double syringe technique is used for drawing
blood.

Time to Test The sample must be immediately dispensed into the sample well of the cartridge
and the cartridge must be inserted immediately into an analyzer.

Repeat Test If a repeat measurement is needed, a fresh sample must be obtained.

ARTERIAL PUNCTURE - GLUCOSE TEST STRIPS (i-STAT®1 ANALYZER)

Anticoagulant Use only fresh whole blood samples. Clear the arterial line before drawing a
blood sample into a syringe that contains sodium heparin, lithium heaparin
or EDTA.

Time to Test Mix the syringe several times immediately before applying the sample to the
target area of the test strip. Allow a drop of blood to form at the tip of the
syringe. Cover the entire target area of the test strip with the blood sample.
The syringe can briefly touch the test strip without affecting results. Use the
sample within 30 minutes of collection.

Art: 714372-01C Rev. Date: 07/12/04 10-5

INDWELLING LINE
Blood Gas, Back flush line with a sufficient amount of blood to remove intravenous
Electrolyte, solutions, heparin or medications that may contaminate the sample. Five to six
Chemistry times the volume of the catheter, connectors and needle is recommended.

Coagualtion If blood must be drawn from an indwelling line, possible heparin contamination
Cartridges should be considered. The line should be flushed with 5mL of saline and the first
5mL of blood or six dead space volumes of the catheter should be discarded.

SKIN PUNCTURE
Device Use a puncture device that provides free-flowing blood. Inadequate blood flow
may produce erroneous results.

Hemolysis Avoid hemolysis (bursting of red cells) due to vigorous massaging or

“milking.”

Hemolysis will cause an increase in potassium results and a decrease in calcium

results.

To increase blood flow, massage a finger gently from about three inches from
the tip to the fleshy portion of the tip.

Avoid hemolysis by allowing residual alcohol to dry over the puncture site.

Tissue Fluid For tests other than PT/INR cartridges, wipe away the first drop of blood as
it may contain excess tissue fluid, which can increase potassium results, and
decrease the other test results. (If only testing glucose by the strip method, it
is not necessary to wipe away the first drop.)

Air Avoid drawing air into the capillary tube.

Anticoagulant Most heparinized capillary tubes are not suitable for electrolyte measurements,
especially ionized calcium, due to the high concentration of heparin (50 U/mL
or more). Use balanced heparin tubes or plain tubes.

If the sample is to be tested on a glucose test strip, the sample can be applied directly
to the target area of the test strip or a capillary tube coated with sodium heparin,
lithium heparin, or EDTA can be used to apply the sample to the test strip.

Time to Test Test samples collected in capillary tubes immediately to avoid clotting (especially
in neonates whose blood may clot more quickly).

Warming Area Blood flow can be stimulated by warming the puncture site. Follow the facility’s
policy and procedure for warming (arterializing) an infant’s heel or other skin
puncture area.

ACT and cTnI Skin puncture samples are not recommended for ACT and cTnI
Cartridges measurements.

PT/INR Cartridges i-STAT PT/INR cartridges should be filled directly from the puncture site by
allowing blood to flow from the site into
the cartridge - no transfer device should
be used.

10-6 Art: 714372-01C Rev. Date: 07/12/04

SAMPLE TRANSFER DEVICES
Dispensers A dispenser can be used to avoid the use of needles when transferring a blood
sample from an blood collection tube.

Do not use dispensers that would introduce air into

the sample when ionized calcium, pH, or PCO2 are
being measured.

For coagulation testing the dispenser must be

plastic and must not contain anticoagulant.

Capillary Tube While a sample can be transferred directly from a

skin puncture to a cartridge, a capillary tube is preferred.

Capillary tubes can be used to transfer sample from a tube to a cartridge. For
coagulation testing, the capillary tube must be plastic and must not contain
anticoagulant.

Syringe A 1cc syringe (such as a tuberculin) and needle (no smaller than 20 gauge) can
be used to withdraw a sample from an blood collection tube.

Take care not to draw air with the sample when ionized calcium, pH or PCO2
are being measured.

For coagulation testing, the syringe must be plastic and must not contain
anticoagulant.

Art: 714372-01C Rev. Date: 07/12/04 10-7

REFERENCES
1. NCCLS. H3-A4, Procedure for the Collection of Diagnostic Blood
Specimens by Venipuncture, 4th ed.; Approved Guideline, NCCLS
document H3-A4 [ISBN 1-56238-350-7]. NCCLS, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087 USA, 1998.

2. NCCLS. H4-A4, Procedure for the Collection of Diagnostic Blood

Specimens by Skin Puncture, 4th ed.; Approved Standard, NCCLS
document H4-A4 [ISBN 1-56238-382-5]. NCCLS, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087 USA, 1999.

3. NCCLS. Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved

Guideline, NCCLS document AST2-A [ISBN 1-56238-375-2]. NCCLS,
940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA,
1999.

4. NCCLS. C31-A2, Ionized Calcium Determinations: Precollection

Variables, Specimen Choice, Collection, Handling 2nd ed.; Approved
Guideline, NCCLS document C31-A [ISBN 1-56238-436-8]. NCCLS,
940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA,
2001.

5. NCCLS. H11-A3, Procedures for the Percutaneous Collection of Arterial

Blood Specimens, 3rd ed.; Approved Standard NCCLS document H11-
A3 [ISBN 1-56238-374-4]. NCCLS, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087 USA, 1999.

6. NCCLS. H18-A2 Procedure for the Handling and Processing of Blood

Specimens; Approved Guideline - Second Edition. NCCLS document
H18-A2 [ISBN 1-56238-388-4]. NCCLS, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898, 1999.

7. NCCLS. H21-A3, Collection, Transport, and Processing of Blood

Specimens for Coagulation Testing and General Performance of
Coagulation Assays; Approved Guideline – Third Edition. NCCLS
document H21-A3 [ISBN 1-56238-363-9]. NCCLS, 940 West Valley
Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 1998.

8. Corriveau, Donna and Fritsma, George (eds.): Hemostasis and

Thrombosis in the Clinical Laboratory. J.B. Lippinncott Company,
Philadelphia, 1988, pp 70-71.

9. NCCLS. Blood Gas and pH and Related Measurements; Approved

Guideline NCCLS document C46-A [ISBN 1-56238-444-9]. NCCLS,
940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA,
2001.

10-8 Art: 714372-01C Rev. Date: 07/12/04

 PROCEDURE FOR HANDLING CARTRIDGES 11
PREPARATION FOR TESTING
Select the Cartridge Select the appropriate cartridge for the test or tests required. While the cartridge
is not fragile, it should be handled as follows to avoid difficulty in filling and
Quality Check failures.

Room Temperature A cartridge should not be removed from its protective pouch until it is at
room temperature (18-30 °C or 64-86 °F). For best results, the cartridge and
analyzer should be at the temperature of the room where they are to be used.
Condensation on a cold cartridge may prevent proper contact with the analyzer.
Allow a single cartridge to stand for 5 minutes and a box of cartridges for 1 hour
at room temperature before use. Use a cartridge immediately after removing
it from its protective pouch — prolonged exposure may cause a cartridge to
fail a Quality Check. If the pouch has been punctured, the cartridge should
not be used. Once cartridges have been brought to room temperature, they
should not be returned to the refrigerator. Cartridges may be stored at room
temperature for two weeks.

Contact Pads Do not contaminate the contact pads with fingerprints or talc from gloves as
the analyzer may not be able to make proper contact with the cartridge.

Calibrant Pack Do not apply pressure to the central area of the label as the calibrant pack inside
could burst prematurely.

Air Vent Do not block the air vent as the sample will not flow to the fill mark and the
calibrant solution will not flow to the sensors.

Contamination To avoid contaminating the analyzer do not use a cartridge on which blood or
any other fluid has spilled. Avoid filling cartridges on surfaces that may cause
the cartridge to pick up fibers, fluid or debris that may lodge in the analyzer.

Art: 714373-01C Rev. Date: 07/12/04 11-1

FILLING AND SEALING CARTRIDGE USING TRANSFER DEVICE
Procedure STEP ACTION

1 Place the cartridge on a flat surface or hold it in a horizontal

position.

2 Direct the tip of the syringe, capillary tube or

dispenser into the sample well.

3 Dispense sample slowly and steadily until

it reaches the fill mark indicated on the
cartridge label. Leave some sample in the
sample well.

4 Fold the snap closure over the

sample well.

5 Press the rounded end of the

closure until it snaps into
place.

Caution Do not hold cartridge between the fingers

if using a syringe with needle to fill.

FILLING AND SEALING PT/INR (PROTHROMBIN TIME) CARTRIDGES USING DIRECT

FINGERSTICK SAMPLING

STEP ACTION

1. Remove cartridge from foil pouch and place the cartridge on a flat
surface.

2. Prepare lancet device and set aside until needed.

3. Clean and prepare the finger to be sampled. Allow finger to dry

thoroughly before sampling.

4. Prick the bottom side of the fingertip with the lancet device.

5. Gently squeeze the finger, developing

a hanging drop of blood and perform
the test with the first sample of blood.
Avoid strong repetitive pressure (“milking”)
as it may cause hemolysis or tissue fluid
contamination of the specimen.

6. Touch the drop of blood against the

bottom of the sample well. Once in
contact with the sample well, the blood
will be drawn into the cartridge.

7. Apply sample until it reaches the fill mark indicated on the

cartridge.

11-2 Art: 714373-01C Rev. Date: 07/12/04

 8. Fold the sample closure over the sample well.

9. Press the rounded end of the closure until it snaps into place.

Note: To further simplify the sample application into the test cartridge, it is
possible to bring the cartridge to the finger for easier application. Do ensure
that the instrument remains on a flat vibration-free surface for testing.

FILLING AND CLOSING A cTnI CARTRIDGE USING TRANSFER DEVICE

1. Following thorough mixing of the sample, direct the transfer device
(either syringe tip or pipette tip) into the inlet port. Apply a single
drop of sample to the inlet port. If the cartridge fill is incomplete as
seen via the fill indicator on the cartridge label, apply a second small
drop until the sample reaches the fill mark.
2. To close the cTnI Cartridge:
a. first anchor the cartridge in place by using the thumb and index
finger of one hand to grasp the cTnI cartridge from its side edges
away from the sample inlet.
b. use the thumb of the other hand to slide the plastic closure clip to
the right until it locks into place over the sample well. Note: When
sliding the closure clip, the index finger of that same hand should not be
placed directly across from the thumb, as this could result in the sample
being pushed onto the user’s glove. This index finger should be placed
just above the position of the sliding clip during closure or not used at
all.

Art: 714373-01C Rev. Date: 07/12/04 11-3

INSERTING AND REMOVING THE CARTRIDGE FROM THE ANALYZER
STEP ACTION

Inserting Cartridge into Analyzer

1 Align the cartridge with the contact pads

facing up and toward the cartridge port.

2 Push the cartridge slowly and smoothly

into the cartridge port until it clicks into
place.

Removing Cartridge from Analyzer

3 Do not attempt to remove the cartridge

while the message “Cartridge Locked”
remains on the screen.

4 When results are displayed, pull the

cartridge straight out of the analyzer.

5. Dispose of the cartridge in a container for biohazards, following

local, state, and national regulatory guidelines.

11-4 Art: 714373-01C Rev. Date: 07/12/04

INCORRECT PROCEDURE
Overview
The cartridge is designed to fill and seal correctly. However, the conditions
described below may occur, especially during the training period. If the
condition is not detected by the operator, the analyzer will detect the condition,
halt the test cycle and display a cause message followed by the action message
“USE ANOTHER CARTRIDGE.”

Condition Operator Action Analyzer Display

Sample beyond fill mark. If the sample flows only slightly beyond the fill mark, the SAMPLE POSITIONED BEYOND
cartridge can still be used. If the sample is close to or enters FILL MARK
the air segment chamber, use another cartridge.
Sample not up to fill mark. If the sample well fills but the sample does not reach the fill SAMPLE POSITIONED SHORT OF
mark, ensure that the air vent (small hole on the underside of FILL MARK
the cartridge) is not blocked. Tilt the cartridge slightly so that
gravity aids the flow. When the sample starts to flow into the
chamber, return the cartridge to the horizontal position.
If the sample is considerably short of fill mark, the analyzer will
detect the condition and halt the test cycle.
Sample well empty. If the sample reaches the fill mark, but the sample well is left INSUFFICIENT SAMPLE
completely empty, there may be insufficient sample for the test.
Air bubbles in sample. If air bubbles are trapped in the sample chamber, discard the INSUFFICIENT SAMPLE
cartridge and fill another.
Sample well overfilled. If the sample well is so full that sample is seen above the UNABLE TO POSITION SAMPLE
sample well after the sample chamber is filled, do not wipe or
absorb the excess with a gauze or tissue but draw the excess
back into the syringe or a capillary tube. If the sample spreads
over the outside of the sample well, an airtight seal may not
form when the cartridge is closed. In this case the analyzer
may not be able to move or position the sample over the
sensors.
Sample clotted. If the sample clots in the sample well the analyzer will not be UNABLE TO POSITION SAMPLE
able to move or position the sample over the sensors.
Cartridge contaminated. If sample spills onto the cartridge or if the cartridge CARTRIDGE ERROR or ANALYZER
has collected debris, discard the cartridge. Inserting a ERROR
contaminated cartridge into the analyzer will cause debris to
build up on the pins that contact the cartridge pads which will
cause a cartridge or analyzer Quality Check code.
Sample pushed beyond fill Avoid applying excess pressure on the closure directly over SAMPLE POSITIONED BEYOND
mark. the sample well as doing so may push the sample beyond the FILL MARK
fill mark.
Cartridge sealed before Closing the cartridge before the sample chamber has filled will SAMPLE POSITIONED SHORT OF
sample reaches fill mark. stop the flow of the sample to the fill mark. FILL MARK
Cartridge not sealed before Failure to close the cartridge before inserting it into the UNABLE TO POSITION SAMPLE.
inserted into analyzer. analyzer will prevent sample movement and can cause the
sample to flow backward and out of the sample well.

Art: 714373-01C Rev. Date: 07/12/04 11-5

11-6 Art: 714373-01C Rev. Date: 07/12/04
 PROCEDURE FOR CARTRIDGE TESTING 12
Caution The following cautions should be taken to prevent damage to the analyzer and
to ensure the safety of the operator and the integrity of results.

• Never look into the barcode scanner beam or point it toward

anyone’s eyes. The beam could cause permanent eye damage.

• Do not attempt to remove a cartridge during the testing cycle. The

force that would be necessary to do so could damage the analyzer.
The message “Cartridge Locked” will remain on the screen until the
analyzer unlocks the cartridge.

• The analyzer may be contaminated with blood from prior use.

Whenever handling the analyzer, cartridges, and peripherals exercise
universal precautions to protect yourself from blood-borne pathogens.
Universal precautions are those procedures and practices, such as
the wearing of gloves, designed to protect personnel from blood-
borne pathogens as well as pathogens from other body substances.
These precautions are based on the assumption that blood, body
fluids or tissue can contain infectious agents and, therefore, should
be treated as a biohazard. For more detailed information, please
refer to either the CDC/NIH manual, "Biosafety in Microbiological
and Biomedical Laboratories", Fourth Edition, 1999, or the WHO
"Laboratory Biosafety Manual", Second Edition, 2003.

To protect from nosocomial infections, decontaminate analyzers

periodically and whenever blood is spilled or transferred to an
analyzer. See under "Cleaning the Analyzer and Downloader" in
section 17 of this manual.

• A falling analyzer may cause injury. Always place the analyzer and
peripherals on a stable surface or in a location where it will not cause
injury if dropped.

• The analyzer may be rendered inoperative by damage due to

mishandling, such as dropping, by exhausting the batteries or by
other causes. Clinical settings that demand fail-safe testing should
reduce this risk by having a backup analyzer or test source available.

• The analyzer should not be used in environmental conditions that

exceed the operating temperature and humidity specifications. An
analyzer that has been exposed to extreme environmental conditions
must be allowed to come to equilibrium with the operating
environment prior to use. Note: the analyzer will display the message
“Temperature Out of Range” until it has reached its operating
temperature.

• The analyzer and its peripherals are not listed by any authority with
respect to suitability for use in oxygen enriched atmospheres.

• Proper procedure must be used to ensure correct manual entry of

patient ID, operator ID, sample type and other data that may affect
the clinician’s interpretation of results.

Art: 714374-01C Rev. Date: 07/12/04 12-1

PERFORMING PATIENT ANALYSIS WITH CARTRIDGE – INFORMATION FIRST DISABLED
Procedure This procedure is used when the analyzer is customized to allow the operator
to enter Operator and Patient IDs after a cartridge has been inserted into the
analyzer. To run immunoassay cartridges in this mode, you must have "Cartridge
Barcode Required" enabled in the analyzer customization.

Analyzer Response /
Display Action
Comments
The display may be blank or Insert filled cartridge into Test cycle initiated. Analyzer
a result may be displayed. analyzer’s cartridge port. may display a startup warning
message. If at any point during the
test cycle a Quality Check fails, the
test cycle will halt and a message
will be displayed indicating the
condition and corrective action.
Scan or Enter Cartridge Press Scan to scan cartridge
Lot Number (if Barcode lot number or manually enter
Required enabled) the lot number and press Enter
Enter or Scan Operator ID Press Scan to scan the If enabled, the analyzer will
Operator ID or manually enter validate the ID. If enabled, the
using the keypad and press analyzer will prompt for the ID to
Cartridge Locked Enter. be repeated.
Scan or Enter Patient ID Press Scan to scan the Patient If enabled, the analyzer will
ID or manually enter using the validate the ID. If enabled, the
keypad and press Enter. analyzer will prompt for the ID to
Cartridge Locked be repeated. If enabled, the most
recent patient ID can be recalled
Note: If an External Simulator by pressing the → key.
was inserted instead of a
cartridge, the analyzer will
prompt for the Patient ID and
then for the Simulator ID.

12-2 Art: 714374-01C Rev. Date: 07/12/04

PERFORMING PATIENT ANALYSIS WITH CARTRIDGE – INFORMATION FIRST DISABLED
(CONTINUED)

Analyzer Response /
Display Action
Comments
Scan or Enter Cartridge Lot Press Scan to scan Cartridge Lot Number or manually enter
Number (if Cartridge Lot the Lot Number and press Enter.
enabled)
i-STAT (Cartridge panel If the Test Selection page is displayed, use the number keys Displays screens enabled in
number) to select tests to be reported. (Press a number key again to the customization profile for the
Time to Results deselect a test.) analyzer.

→Page If the Chart page is automatically displayed, enter the required

information. If not, press the → key to go to the Chart page.
Cartridge Locked

ID Enter information on Chart page if desired. Use the Enter key Information entered on the Chart
Scan or Enter Data to move from field to field. and Test Selection pages can be
For CPB the choices are 1 – YES and 2 – NO. Default is NO. changed up until:
Sample Type _
Use the → key to return to the results page. • the next test is initiated.
Field 1 ---------
• results are transmitted.
Field 2 ---------
• the Menu key is used
Field 3 --------- to backup to the Test
Pt Temp ----- Menu screen.
FIO2 --- • A test option is selected.
CPB NO Note:
1-ART 4-CAP CPB is included on the screen
only when the cartridge includes a
2-VEN 5-CORD
sensor for hematocrit.
3-MIX 6-OTHR

→ Page
Cartridge Locked
Results or Results Ready If not on results page, press the → key to return to the results Analyzer unlocks the cartridge and
message page. is ready for another test.
Tests disabled in customization
will not be displayed.
Optional prompt above If Comment Code is enabled, scan or manually enter a The analyzer can be customized
results comment code. to request a comment code for
results that are inside action
ranges and for results that exceed
action ranges.
Results page Test Options
1-Test Options Patient

1 - Next Patient
2 - Same Patient
3 - History

Art: 714374-01C Rev. Date: 07/12/04 12-3

PERFORMING PATIENT ANALYSIS WITH CARTRIDGE – INFORMATION FIRST ENABLED
Procedure This procedure is followed when the analyzer has been customized to require
the operator to enter Operator and Patient IDs before inserting a cartridge. If
the operator inserts a cartridge before entering Operator and Patient IDs, the
message “Remove Cartridge” will be displayed. To run immunoassay cartridges
in this mode, you must have "Cartridge Lot Number Required" enabled in the
analyzer's customization profile.

Analyzer Response /
Display Action
Comments
Blank or active. Press the On/Off key to turn on Logo briefly displayed followed by
the analyzer. Test Menu.
If the analyzer is already on, If a test strip or cartridge is
press the Menu key to get inserted in analyzer, the analyzer
to the Test Menu, or turn the will prompt to remove.
analyzer off and back on again. Analyzer may display a startup
warning or Quality Check
message.
Test Menu Press 2 to select i-STAT If the glucose strip function is
1 – Last Result Cartridge. disabled, option 3 will not be
displayed.
2 – i-STAT Cartridge
3 – PCx Glucose Strip
Enter or Scan Operator ID Press Scan to scan the If enabled, the analyzer will
Operator ID or manually enter validate the ID. If enabled, the
using the keypad and press analyzer will prompt for the ID to
Enter. be repeated.
Scan or Enter Patient ID Press Scan to scan the Patient If enabled, the analyzer will
ID or manually enter using the validate the ID. If enabled, the
keypad and press Enter. analyzer will prompt for the ID to
be repeated. If enabled, the most
recent patient ID can be recalled
by pressing the → key.

12-4 Art: 714374-01C Rev. Date: 07/12/04

PERFORMING PATIENT ANALYSIS WITH CARTRIDGE – INFORMATION FIRST ENABLED
(CONITNUED)
Analyzer Response /
Display Action
Comments
Scan or Enter Cartridge Lot Press Scan to enter the Lot Scanning the cartridge lot number
Number (if enabled) Number or manually enter the is required for cTnI testing.
Lot Number and press Enter.
INSERT CARTRIDGE Insert filled cartridge into the The analyzer will display the
analyzer’s cartridge port. “INSERT CARTRIDGE” message
for 15 minutes to allow for blood
collection before turning off.
Identifying Cartridge please If Test Selection is displayed, Displays screens enabled in
wait… use the number keys to select the customization profile for the
i-STAT (Cartridge panel tests to be run. (Press a analyzer.
number) number key again to deselect If at any point during the test cycle
a test.) a Quality Check fails, the test cycle
Time to Results
If Chart page is displayed, scan will halt and a message will be
→ Page or manually enter the required displayed indicating the condition
Cartridge Locked information. If not, press the → and corrective action.
key to go to the Chart page.
Screens may be displayed
automatically
ID Enter information on Chart Information entered on the Chart
Scan or Enter Data page if desired. Use the Enter and Test Selection pages can be
key to move from field to field. changed up until:
Sample Type _
For CPB the choices are • the next test is initiated.
Field 1 ---------
1 – YES and • results are transmitted.
Field 2 ---------
2 – NO. • the Menu key is used
Field 3 --------- to backup to the Test
Default is NO.
Pt Temp ----- Menu screen.
Use the → key to return to the
FIO2 --- results page. • A test option is selected.
CPB NO Note:
1-ART 4-CAP CPB is included on the screen
only when the cartridge includes a
2-VEN 5-CORD
sensor for hematocrit.
3-MIX 6-OTHR

→ Page
Cartridge Locked

Art: 714374-01C Rev. Date: 07/12/04 12-5

PERFORMING PATIENT ANALYSIS WITH CARTRIDGE – INFORMATION FIRST ENABLED
(CONITNUED)

Analyzer Response /
Display Action
Comments
Results or Results Ready If not on results page, press Analyzer unlocks the cartridge and
message the→ key to return to the is ready for another test.
results page.
Optional prompt above If Comment Code is enabled, The analyzer can be customized
results scan or manually enter a to request a comment code for
comment code. results that are inside action
ranges and for results that exceed
action ranges.
Results page Test Options
1-Test Options Patient
1 - Next Patient
2 - Same Patient
3 - History

12-6 Art: 714374-01C Rev. Date: 07/12/04

INTERPRETATION OF DISPLAYED RESULTS
Results Display Test results are displayed with numerical concentration values in the units
selected for the Customization profile. For patient test
results, bar graphs depicting the values in relation to
reference ranges are also displayed. Reference ranges are
marked on the bars by tic marks. When all test values
are within their reference ranges, the tic marks will
be centrally aligned. The bar graphs can be used as a
visual cue for distinguishing between “normal” and
“abnormal” results. Blood gas, coagulation, and cTnI
results are not displayed with bar graphs and reference
ranges.

If a value exceeds the reference range, the bar graph

may be rescaled to show the reference range and value
in relation to the measurement range.

Reportable Ranges The reportable range (sometimes referred to as the

linear range) is the concentration range over which test
results are valid. Reportable ranges programmed into
the analyzer can are listed in the Cartridge and Test
Information section.

Reference Ranges Reference ranges (sometimes referred to as normal

ranges) in the default Customization profile are
derived from the literature and are listed in the
Cartridge and Test Information section as well as in
the Customization option on the analyzer. Variables
such as sex, age, heritage and other demographic
factors of a population may cause a shift in these
ranges. Therefore, it is usually recommended
that each facility determine its own reference
ranges. Reference ranges can be changed using the
Customization function on the Central Data Station.

Action Ranges Action ranges (sometimes referred to as critical values)

indicate results that require immediate attention. When
a test result falls outside the action range it is flagged as
either above the high action range  or below the low
action range . Action ranges are programmed into
the analyzer using the Customization function on the Central Data Station and
can be viewed on the analyzer under the Customization option.

Art: 714374-01C Rev. Date: 07/12/04 12-7

Flags When the analyzer detects an out-of-range result or an uncharacteristic sensor
signal, the condition is indicated by a flag. See table below for flags and symbols
used with results. Note: The reportable range flags do not apply when testing
is performed under Quality Tests Option 3 – Cal Ver. Action flags do not apply
to Option 1 – Control or Option 3 – Cal Ver.

Analyzer Response /
Display Action
Comments
> The result falls above the reportable If an ACT result is displayed as >1000,
range of the test. the result should be reported as “greater
than 1000 seconds.”
< The result falls below the low end of the If a pH result is displayed as <6.5, the
reportable range of the test. result should be reported as “less than
6.5.”
<> The result is dependent on another test If a sodium result is displayed as >180,
that has been flagged. the calculations for potassium, chloride,
The < > flag will also be displayed for BUN/Urea and hematocrit, which depend
TCO2, pH, PCO2, HCO3, anion gap, upon the sodium measurement, will be
base excess and sO2 if the TCO2 is flagged < >.
outside the reportable range. Because
the values outside the reportable range of
TCO2 are essentially non-physiological,
the TCO2 range check is used as an
additional quality check on the validity of
the underlying pH and PCO2 results.
 The result is above the high action range. If the action ranges for potassium are 3.2
and 5.5, a result of 6.0 will be displayed
as 6.0 .
 The result is below the low action range. If the action ranges for potassium are 3.2
and 5.5, a result of 3.0 will be displayed
as 3.0 .
*** The signals from a particular sensor The sample should be retested using
are uncharacteristic. Uncharacteristic another cartridge.
signals can be caused by a compromised If the stars reappear, refer to the
sensor or by an interferent in the sample. troubleshooting paragraph in this section
This flag also appears for any test of the manual.
dependent on another test which is
flagged with stars.

12-8 Art: 714374-01C Rev. Date: 07/12/04

TROUBLESHOOTING
Warning Message If testing is disabled due to warning message, the condition must be corrected
and the analyzer must be turned off and back on again before testing is
enabled.

Message and See Troubleshooting section

Quality Check Code

*** Instead of Results Stars appear in place of results if the analyzer detects that the sensor’s signal is
uncharacteristic. Since the sensor check is part of the i-STAT quality system,
an occassional result will be flagged due to a bad sensor. Other causes of this
flag are improperly stored cartridges or an interfering substance in the patients
sample, either extrinsic, such as the wrong anticoagulant, or intrinsic such as
medication. Also, aged samples may contain products of metabolism that can
interfere with the tests.

• Check the supply of cartridges in use with a control solution.

• If the control is in range, draw a fresh sample from the patient and
retest.
• If the stars appear in place of results again, there may be an
interfering substance. Refer to the Cartridge and Test Information
section for a list of interfering substances. Test the sample using
another method.
• If the control is out-of-range or if stars are displayed in place of
results, there may be a problem with the cartridge lot number. Use
another lot number or repeat the test using another method, and
contact your support representative. (Refer to Support Services
information in the Troubleshooting section.)

Unexpected Results When results do not reflect the patient’s condition, repeat the test using a fresh
cartridge and sample. If results are still suspect, test the lot of cartridges in use
with i-STAT control solutions. If the controls are in range, there may be an
interfering substance in the sample. Check the Cartridge and Test Information
sheets for the test in question. Test by another method to verify the result.
If the controls are out of range there may be a problem with the cartridge lot
number. Use another lot number or repeat the test using another method, and
contact your support representative. (Refer to Support Services information in
the Troubleshooting section.)

Art: 714374-01C Rev. Date: 07/12/04 12-9

 PROCEDURES FOR GLUCOSE TEST STRIP TESTING 13
Operating Follow the recommended guidelines to obtain the most accurate results.
Guidelines for All
Samples • Use the test strips before their expiration date.
• Do not use test strips that are wet, bent, scratched or damaged.
• Use the test strip immediately after opening its foil packet.
• Do not scan a packet’s barcode and use a test strip from another
packet. This may cause incorrect assay results to be generated.
• Cover the entire target area of the test strip with the blood sample.
The test results will not be affected if the target area has been briefly
touched with the patient’s finger, a syringe, a capillary tube or
pipette.
• If the test fails to start, apply a second drop of blood to the target area
within 30 seconds. If the test fails to start after the second drop is
applied, or if more than 30 seconds have passed, discard the used test
strip and repeat the test.
• After the blood is applied to the test strip and the test starts, do not
touch the strip.
• Use a new test strip when repeating a patient test.
• Refer to the package insert in the test strip box for specific directions
on storage and use of the test strips.
• Store analyzers in use near the testing location or in an area close to
the same temperature as the testing area. Do not store analyzers near
equipment that gives off heat or in the direct sunlight. If an analyzer
is moved to a testing area that is slighly cooler or warmer (5 °C or
9 °F) than the previous testing or storage area, allow 30 minutes for
the analyzer to equilibrate to the temperature of the new testing area
before using the analyzer. If the temperature difference is substantial
allow 90 minutes for equilibration.
• i-STAT 1 Analyzers require a modification to the glucose strip port in
order to be compatible with Precision PCx Plus Glucose Test Strips.
This modification can be identified by inspecting the glucose strip
port. If a blue strip port spacer is present, the modification is in
place. If a blue strip port spacer is not present, please contact your
local support representative for information on modifying the port.
The modification is easily self-installed.

Art: 714375-01B Rev. Date: 04/04/04

PERFORMING PATIENT GLUCOSE ASSAY WITH TEST STRIP
Procedure If the analyzer displays a message not indicated in this procedure, refer to the
Troubleshooting section of this manual.

Caution Never look into the barcode scanner beam or point it toward anyone’s eyes.
The beam could cause permanent eye damage.

Display Action Analyzer Response

Blank or active. Press the On/Off key to turn the Logo briefly displayed followed
analyzer on. by Test Menu.
If the analyzer is on, press the
Menu key to return to the Test
Menu or turn the analyzer off
and back on.
Test Menu Press 3 to select PCx Glucose REMOVE STRIP will be
1 – Last Results Strip. displayed if a strip is inserted
before the analyzer displays
2 – i-STAT Cartridge INSERT STRIP.
3 – PCx Glucose Strip
Precision PCx Blood Glucose Press 1 to select Patient. Possible message: “Control
Strip Required Patient Testing
1 – Patient Disabled”

2 - Control
Scan or Enter Operator ID Press Scan to scan the If enabled, the analyzer will
Operator ID or manually enter validate the ID. If enabled, the
the Operator ID using the analyzer will prompt for the ID
keypad and press Enter. to be repeated.
Scan or Enter Patient ID Press Scan to scan the Patient If enabled, the analyzer will
ID, or manually enter the Patient validate the ID. If enabled, the
ID using the keypad and press analyzer will prompt for the ID
Enter. to be repeated. If enabled, the
most recent patient ID can be
recalled by pressing the Ú key.
Scan or Enter Strip Lot Number Press Scan to scan the Strip Possible messages: “Lot
Lot Number, or manually enter Expired, “ “Invalid Number, “
the Strip Lot Number using the “Invalid Length, “ “Strip Lot xxx
keypad and press Enter. Is Not in List”
(see Note below)

13-2 Art: 714375-01B Rev. Date: 04/04/04

PERFORMING PATIENT GLUCOSE ASSAY WITH TEST STRIP (CONTINUED)

Display Action Analyzer Response

Select Sample Type Press 1 or 2 to select the This prompt will not be
1 – Arterial or Capillary correct sample type. displayed if the analyzer has
been customized for one sample
2 - Venous type only.
INSERT STRIP Open the foil test strip packet at The analyzer will display the
the notch and tear up or down “INSERT STRIP” message for
to remove the test strip. 2 minutes. If the strip is not
(see figure 13.1) inserted, the analyzer will turn
figure 13.1 off.
With the contact bars facing up,
insert the test strip into the test
strip port until it stops.
Apply Apply a drop of blood directly The analyzer beeps when the
Arterial/Capillary Sample from the patient’s finger or a sample is accepted. The tests
syringe to the target area on the starts automatically as the
or test strip. sample is accepted.
Apply Venous Sample (see figure 13.2)
Precision PCx Blood Glucose Press the Ú key to enter The analyzer counts down 20
Strip Chart page information seconds, then displays the test
figure 13.2 if desired. Press the Ú
Time to Results result.
key again to return to the
Ú Page result page. If the Ú key is pressed, the
Chart page will be displayed.
The sample type will be
displayed along with 3 free
fields in which comments of 9
characters each can be entered.
The analyzer may be customized
to present the Chart page
automatically.

Art: 714375-01B Rev. Date: 04/04/04 13-3

PERFORMING PATIENT GLUCOSE ASSAY WITH TEST STRIP (CONTINUED)

Display Action Analyzer Response

Result Remove the test strip If Action Ranges are
from the analyzer when enabled, and the result
finished testing. is outside the range, an
up (high) or down (low)
arrow will be displayed
with the result.

If Comment Code is
enabled, the analyzer will
request the operator to
Scan or Enter Comment
Code. Up to 3 characters
can be entered.
Result Test Options

1 – Test Options Patient

1 - Next Patient
2 - Same Patient
3 - History

Note: If valid strip lot numbers are programmed into the analyzer, only the
first six digits of the strip lot number need be entered via the keypad.
The analyzer will fill in the remaining eight digits of the 14 digit lot
number. If the strip lot number is not recognized the analyzer will
prompt for the remaining 8 digits.

CAUTION
The following cautions should be taken to prevent damage to the analyzer and
to ensure the safety of the operator and the integrity of results.

• Never look into the barcode scanner beam or point it toward

anyone’s eyes. The beam could cause permanent damage in the eye.
• The analyzer may be contaminated with blood from prior use.
Whenever handling the analyzer, exercise standard precautions to
protect yourself from blood-borne pathogens. Standard precautions
are those procedures and practices, such as the wearing of gloves,
designed to protect personnel from blood-borne pathogens as well as
pathogens from other body substances. These precautions are based
on the assumption that blood, body fluids or tissue can contain
infectious agents and, therefore, should be treated as a biohazard.
• A falling analyzer may cause injury. Always place the analyzer on
a stable surface or in a location where it will not cause injury if
dropped.
• The analyzer may be rendered inoperative by damage due to
mishandling, such as dropping, by exhausting the batteries, or by
other causes. Clinical settings that demand fail-safe testing should
reduce this risk by having a backup analyzer or test source available.

13-4 Art: 714375-01B Rev. Date: 04/04/04

 • The analyzer should not be used in environmental conditions that
exceed the operating temperature and humidity specifications.
An analyzer that has been exposed to extreme environmental
conditions must be allowed to come to equilibrium with the
operating environment prior to use. Note: the analyzer will display
the message “Temperature Out of Range” until it has reached its
operating temperature.
• Proper procedure must be used to ensure correct manual entry of
patient ID, operator ID, sample type and other data that may affect
the clinician’s interpretation of results.
• Follow test strip QC procedures and frequency described in the
Quality Control section of this manual.

INTERPRETATION OF DISPLAYED RESULTS

Results Display The glucose value is displayed in the units
selected for the analyzer’s customization profile.
The result is also displayed as a bar graph with
the Reference Range depicted as tic marks under
the graph.

Reportable Range The reportable range (linear range) is the

and < and > Flags concentration range over which test results are valid.
When a result falls below the reportable range it is
displayed as < 20 mg/dL or <1.1 mmol/L. For the
Precision PCx blood glucose strip, when a result
falls above the reportable range it is displayed as
>600 mg/dL or >33.3 mmol/L. The PCx Plus strip
will display >500mg/dL or > 27.8 mmol/L

Reference Range The reference range (normal range) pre-

programmed into the analyzer is derived from the literature and can be changed
using the Customization function on the Central Data Station.

Action Range and ↓ Action ranges can be programmed into the analyzer using the Customization
↑ Flags function on the Central Data Station. Results falling below the lower action
range will be displayed with ↓ and results falling above the upper action range
will be displayed with ↑.

Art: 714375-01B Rev. Date: 04/04/04 13-5

TROUBLESHOOTING
Possible Reasons • Hematocrit < 20 %PCV or 0.20.
for Higher than
Expected Results • Serum or plasma samples used instead of whole blood.
• Room (ambient) temperature > 104 °F or 40 °C.
• Relative humidity >90%
• Venous blood tested in capillary or arterial mode.

Possible Reasons • Hematocrit >70%PCV or 0.70.

for Lower than
Expected Results • Room temperature <59 °F or 15 °C.
• Capillary or arterial blood tested in venous mode.
• Relative humidity <10%.
• Acetaminophen >100 µg/mL.
• Hyperglycemic-hyperosmolar state (with or without ketosis).
• Severe dehydration, hypotension or shock.
• Water or alcohol remaining on the puncture site.
• Venous or arterial whole blood sample not tested within 30 minutes
after collection.

Repeat Testing When the > flag occurs, or if the result is outside the action ranges designated
for the location, the sample must be tested by another method, such as an
i-STAT glucose cartridge, in order to obtain a result.

13-6 Art: 714375-01B Rev. Date: 04/04/04

 QUALITY CONTROL 14
Overview This section describes the steps to be taken to verify the performance of the
analyzer, cartridges and test strips. The rationale for the i-STAT catridge and
analyzer quality regimen is described in the Theory section of this manual.

Customization The quality control behavior of the analyzer can be customized via the Central
Data Station or analyzer Customization Change function to:

• turn the external Electronic Simulator reminder on or off.

• prompt the operator to use the external Electronic Simulator at
scheduled intervals.
• turn the internal Electronic Simulator on or off , and select the
simulator test cycle intervals.
• disable further cartridge testing when the internal Electronic
Simulator test fails.
• include the Normal/Mid Glucose Control in the control regimen for
test strip testing.
• prompt the operator to test strip controls in intervals of hours, at
daily pre-determined times, or by number of patient tests.

See the Customization section for default values.

Data Retention Quality control data is transmitted to the Central Data Station. If a Central
Data Station is not being used, the charts at the end if this section can be used
to record liquid and electronic control results.

QUALITY CONTROL FOR i-STAT CARTRIDGES AND THE ANALYZER’S CARTRIDGE TEST CYCLE
Verify Newly 1. Verify that the transit temperatures were satisfactory using the four-
Received Cartridges window temperature indicator strip included in the shipping container.

2. From each lot in each shipment of cartridges, analyze multiple levels of

i-STAT controls (and MeterTrax™ controls if testing for hematocrit) using
any verified analyzer.

Verify Performance Verify the performance of each analyzer on site using the Electronic Simulator
of Analyzers Daily (external or internal) once a day on the days the analyzers are in use. Note
that regulatory or accreditation requirements may dictate more frequent
intervals.

Check Refrigerator Verify that the cartridges stored in the refrigerator are within the expiration
Storage Daily date printed on the boxes.

Verify that the storage refrigerator did not exceed the temperature limits of 2 to
8 °C (35 to 46 °F). If storage conditions are in doubt, use controls to verify that
the cartridges are performing properly. This is especially important if freezing
conditions are suspected at the back of the refrigerator.

Art: 714376-01C Rev. Date: 07/12/04 14-1

Check Room Verify that the cartridges stored at room temperature are within the expiration
Temperature date and that the cartridges have been out of the refrigerator less than two
Storage Daily weeks. If the temperature at which the cartridges are stored is in doubt, use
controls to verify that the cartridges are performing properly.

Check Thermal i-STAT analyzers contain a thermal control subsystem consisting of two thermal
Control System probes with thermistors and heating contact wires. When measurements are
Twice a Year performed at a controlled temperature, the thermal probes in the analyzer
contact the metalized area under the chips in the cartridge and maintain the
temperature of the sensors and the fluids that come into contact with these
sensors at the required temperature ± 0.15°C.

A quality check is performed on the thermal probes each time the external
Electronic Simulator is used. To complete this check, the surface temperature
of the external Electronic Simulator must not fluctuate. If this condition is not
met, the thermal probe check is not completed. Therefore, i-STAT recommends
that the thermal probe check be verified twice a year.

Check the The analyzer uses ambient temperature measurements to ensure that the
Analyzer Ambient temperature is within the operating range and in the extrapolation of
Temperature ambient temperature measurement results for ionized calcium, pH and PCO2
Reading Once a Year to 37 °C results.

14-2 Art: 714376-01C Rev. Date: 07/12/04

CONTROLS FOR BLOOD GAS/ELECTROLYTE/METABOLITE CARTRIDGES
Control Solutions Aqueous assayed control fluids are available for verifying the integrity of newly
received cartridges. i-STAT Level 1, 2 and 3 Control are formulated at three
clinically relevant levels with known pH and with known concentrations of:

Sodium PCO2 Glucose

Potassium PO2 Lactate
Chloride BUN/Urea
Ionized Calcium Creatinine
Each level of control is packaged in a box of 10 ampules with a sheet with
target values and acceptable ranges. Control solutions are contained in 1.7
mL glass ampules.

The control solutions do not contain human serum or serum products, but do
contain buffers and preservatives.

Reactive Ingredients
Calibration Calibration Calibration
Calibration Verification Verification Verification Calibration
Analyte Verification Level 2 and Level 3 and Level 4 and Verification
Level 1 Control Control Control Level 5
Level 1 Level 2 Level 3
Na (mmol/L) 108 127 141 169 187
K (mmol/L) 2.3 3.1 4.0 6.8 8.5
Cl (mmol/L) 71 85 100 122 133
Glu (mmol/L) 1.8 2.5 7.3 17 35
Urea (mmol/L) 44.6 18 4 2.7 1.8
iCa (mmol/L) 2.5 1.6 1.3 0.8 0.2
Lac (mmol/L) 19.5 8.4 2.3 1 0.6
Crea (µmol/L) 1486 386 155 46 17
PO2 (mmHg) 43 61 100 140 400
PCO2 (mmHg) 95 66 30 22 18
H (pH)
+
6.81 7.15 7.41 7.60 7.95

Storage Refrigerated storage at 2 to 8 °C (35 to 46 °F) should be maintained until the

printed expiration date on the box and ampule labels.

Control solutions may also be stored at room temperature for up to 5 days (18
to 30 °C or 64 to 86 °F). Prolonged storage at temperatures greater than 30 °C
(86 °F) may cause changes in the values of some analytes. Do not use beyond
the expiration date on the box and ampule labels.

Best Results For best results, ampules, cartridges and analyzer should be at the same
temperature.

Art: 714376-01C Rev. Date: 07/12/04 14-3

Ampule Use When using cartridges that contain sensors for pH, PCO2, PO2 and ionized
calcium, a separate ampule must be used for each cartridge being tested.

Do not use the solution left in a syringe, ampule or capillary tube for additional
testing of cartridges that contain sensors for ionized calcium, pH, PCO2, or PO2.
However, cartridges without these sensors may be tested with remaining fluids
if within 10 minutes of opening the ampule.

Before Use i-STAT control solutions require different temperature stabilization times
depending on whether or not oxygen is to be measured. If oxygen is to be
measured, equilibrate the ampule for 4 hours. If not, equilibrate the ampule
for approximately 30 minutes at room (ambient) temperature.

Procedure STEP ACTION

1 Access the i-STAT Cartridge Control option under Quality Tests in

the Administration Menu. Enter the required information. The
analyzer allows 15 minutes (or the customized timeout) to insert
the cartridge after the last data entry.
2 Immediately before use, shake the ampule vigorously for 5 to 10
seconds to equilibrate the liquid and gas phases.
To shake, hold the ampule at the tip and bottom with forefinger
and thumb to minimize increasing the temperature of the solution.
If necessary, tap the tip of the ampule to send solution back into
the bottom section of the ampule.
3 Protect fingers with gauze, tissue or glove, or use an ampule breaker
to snap off the tip of the ampule at the neck.
4 Immediately transfer the solution from the ampule into a capillary
tube or syringe, and then immediately transfer the solution into a
cartridge.
5 Immediately seal the cartridge and insert it into an analyzer – it is
important not to expose the solution to room air since this will alter
the results. Note: Since aqueous based solutions such as controls
lack the buffering capabilities of whole blood, the transfer process
from ampule to cartridge must be more expedient than with a
patient sample.

Transfer with Plain capillary tubes are recommended to transfer an aqueous control from the
Capillary Tube ampule to the cartridge. When using a capillary tube (fresh capillary tubes with
sufficient fill capacity are recommended), fill from the bottom of the ampule
to avoid drawing air into the capillary tube. Avoid drawing solution from the
surface by placing a finger over the far end of the tube as it is inserted into the
ampule. Once the open end of the tube rests at the bottom of the ampule,
uncover the other end to allow filling by capillary action.

Transfer with Plain syringes are recommended to transfer an aqueous control from the ampule
Syringe to the cartridge. When using a syringe (fresh 1cc or 3cc sterile syringe with
16 - 20 gauge needles are recommended), slowly draw approximately 1mL of
solution from the bottom of the ampule.

If air is trapped between the leading edge of the solution and the plunger, do
not invert the syringe to expel it; this will not affect solution near the tip of
the syringe.

If air bubbles are continually drawn into the syringe, or if a bubble is trapped
near the tip of the syringe, discard the ampule and syringe and use a fresh
ampule and syringe.

Expel one or two drops from the syringe before filling the cartridge.
14-4 Art: 714376-01C Rev. Date: 07/12/04
Target Values Target values (determined by testing multiple ampules of each level using
multiple lots of cartridges and i-STAT analyzers that have passed the Electronic
Simulator test) are printed on a value assignment sheet included with each box
of control ampules.

Always be sure that the lot number printed on the insert matches the lot number
on the label of the ampule in use, and that the software revision above the
target value table matches the software revision in the analyzer.

Ranges The ranges displayed represent the maximum deviation expected when controls
and cartridges are performing properly.

Should results outside the ranges be obtained, refer to the Troubleshooting

section that follows the Procedure for Testing Controls.

Target Values are specific to the i-STAT System. Results obtained from these
aqueous controls with other methods may differ due to sample matrix
effects.

Correction of PO2 at The partial pressure of oxygen in a solution will change as it equilibrates to
Extreme Altitude the surrounding ambient pressure. The rate of change is faster in aqueous
solutions than in whole blood due to the absence of red blood cells containing
hemoglobin which binds oxygen molecules. This is of practical significance
when testing aqueous solutions on blood gas analyzers as there will be a
detectable shift in the partial pressure of oxygen in the sample as it equilibrates
to the pressure in the flowpath of the analyzer.

The ranges for i-STAT aqueous control solutions are established for the degree
of oxygen equilibration which occurs in the cartridges at or near sea level.
PO2 results for aqueous solutions, including i-STAT controls and Calibration
Verification Set and proficiency (external quality control) samples, can be
corrected for higher altitude environments using the following equations.
Observed PO2 values should be corrected before comparing them to the values
in the value assignment sheet included with each box of i-STAT controls.

Equations:
For PO2 values below 150 mmHg:
PO2 corrected = PO2 observed + (0.067 x (760 – BP))
Where BP is the barometric pressure reading from the Analyzer
Status screen.
(Approximate change: For every decrease of 15 mmHg in pressure from
760 mmHg, add 1 mmHg to observed value.)

For PO2 value above 150 mmHg:

PO2 corrected = PO2 observed + (0.029 x (760 – BP))
Where BP is the barometric pressure reading from the Analyzer
Status screen.
(Approximate change: For every decrease of 35 mmHg in pressure from
760 mmHg, add 1 mmHg to observed value.)

Art: 714376-01C Rev. Date: 07/12/04 14-5

CONTROLS FOR HEMATOCRIT SENSOR
Meter Trax™ Whole Blood Reference Control for Glucose, Hemoglobin and
Hematocrit (Meter Trax is a trademark of Hematronix, Inc.) is recommended
as a control solution for the hematocrit sensor. Meter Trax is available in three
levels: Low, Mid and High in boxes of one level (6x2mL) or boxes of three
levels (6x2mL or 3x2mL).

The Quality Test option under the Administration Menu must be used when
testing this control and only the hematocrit result will be reported.

CONTROLS FOR ACT CARTRIDGES

Intended Use The i-STAT® ACT Control Level 1 and ACT Control Level 2 are intended for use
to verify the integrity of newly received i-STAT ACT cartridges. The controls
produce clotting times expected for moderate and high level heparinization
to indicate that the cartridges are functioning properly.

Contents Each level of control is packaged as a box of 5 vials of lyophilized human plasma
and 5 vials of 9.5 ± 1.5 mmol/L calcium chloride diluent.

Storage i-STAT ACT controls, Levels 1 and 2, are contained in 6-mL vials. Separate
6-mL vials contain 1-3 mL of calcium chloride solution for reconstitution.
Refrigerated storage at 2 to 8ºC (35 to 46ºF) should be maintained until the
printed expiration date on the box and vial labels. Do not use beyond the
expiration date on the box and vial labels.

Control solutions may also be stored at room temperature for up to 4 hours (18
to 30°C or 64 to -86°F). If left out longer than 4 hours at room temperature,
they should be discarded.

Warnings and Handle this product using the same safety precautions used when handling any
Precautions potentially infectious material. The human plasma used in the preparation
of this product has been tested by FDA approved test methods and found
negative/non-reactive for HIV-1, HIV-2, HBsAg, and HCV. However, no known
test method can offer complete assurance that products derived from human
blood will not transmit infectious disease.

Dispose of this product as biohazardous waste according to all local, state, and
national regulations.

14-6 Art: 714376-01C Rev. Date: 07/12/04

Directions for Use Prior to testing, vials containing the lyophilized plasma and CaCl2 reconstituting
fluid should stand at room temperature (18 - 30ºC or 64 - 86ºF) for a minimum
of 45 minutes. For best results, vials, cartridges, and analyzers should be at the
same temperature.

Reconstitute only one level of control plasma at a time. CONTROL SOLUTIONS

MUST BE USED IMMEDIATELY (less than 30 seconds) AFTER COMPLETING
THE RECONSTITUTION AND MIXING STEPS.

STEP ACTION

1 After 45 minute room temperature equilibration, remove the cap

and stopper from one lyophilized human plasma control vial and
remove the cap from one vial of calcium chloride reconstituting
fluid.
2 Pour the entire contents of the calcium chloride vial into the
lyophilized human plasma control vial. Place the stopper back
in the reconstituted control vial, sealing the vial appropriately so
that the contents do not leak or spill out.
3 Allow the vial to sit at room temperature for 1 minute.
4 Mix the contents of the vial by swirling gently for 1
minute, then inverting slowly for 30 seconds.
Note: To minimize foaming of the control sample, avoid vigorous
or rapid mixing motion. Visually inspect the control vial to
ensure that the sample is fully reconstituted. If not, discard the
reconstituted fluid and start over with fresh vials.
5 Using a plastic transfer pipette, plastic syringe, or plastic capillary
tube with no anticoagulant, immediately transfer the solution
from the vial into the ACT cartridge
6 Immediately seal the cartridge and insert it into an analyzer.
Note: Additional ACT cartridges may be tested with the remaining
fluid if used within 30 seconds of complete reconstitution of the
sample.

Control Target Target values (determined by testing multiple vials of each level using multiple
Values and lots of i-STAT cartridges with analyzers that have passed the Electronic Simulator
Expected Ranges test) are printed on a value assignment sheet included in each box of control
vials. The ranges displayed represent the maximum deviation expected when
controls and cartridges are performing properly. Should results outside the
range be obtained, refer to the Troubleshooting portion of this section of the
i-STAT System Manual (page 14-17). Always be sure that the lot number printed
on the value assignment sheet matches the lot number on the label of the vial
in use, and that the software revision above the table matches the software
revision in the analyzer (check the status page on the analyzer).

Note: Target values are specific to the i-STAT System; results obtained from these
reconstituted control plasmas may differ if used with other methods.

Art: 714376-01C Rev. Date: 07/12/04 14-7

CONTROLS FOR PT/INR CARTRIDGES

Intended Use The i-STAT® PT Control Level 1 (normal) and PT Control Level 2 (abnormal)
are used to verify the integrity of newly received PT/INR cartridges.
Contents Each level of control is packaged as a box of 5 vials of lyophilized human
plasma and 5 vials of calcium chloride diluent. The Level 1 control vials contain
9.5 ± 1.5 mmol/L calcium chloride, while the Level 2 control vials contain
12 ± 2.0 mmol/L calcium chloride.
Storage i-STAT PT controls, Levels 1 and 2, are contained in 6-mL vials. Separate
6-mL vials contain 1-3 mL of calcium chloride solution for reconstitution.
Refrigerated storage at 2 to 8ºC (35 to 46ºF) should be maintained until the
printed expiration date on the box and vial labels. Do not use beyond the
expiration date on the box and vial labels.

Control solutions may also be stored at room temperature for up to 4 hours (18
to 30°C or 64 to -86°F). If left out longer than 4 hours at room temperature,
they should be discarded.

Warnings and Handle this product using the same safety precautions used when handling any
Precautions potentially infectious material. The human plasma used in the preparation
of this product has been tested by FDA approved test methods and found
negative/non-reactive for HIV-1, HIV-2, HBsAg, and HCV. However, no known
test method can offer complete assurance that products derived from human
blood will not transmit infectious disease.
Dispose of this product as biohazardous waste according to all local, state, and
national regulations.
Directions for Use Prior to testing, vials containing the lyophilized plasma and CaCl2
reconstituting fluid should stand at room temperature 18-30ºC (64-86ºF) for a
minimum of 45 minutes. For best results, vials, cartridges, and analyzers should
be at the same temperature.

Reconstitute only one level of control plasma at a time. CONTROL SOLUTIONS

MUST BE USED IMMEDIATELY (less than 30 seconds) AFTER COMPLETING
THE RECONSTITUTION AND MIXING STEPS.
STEP ACTION

1 After 45 minute room temperature equilibration, remove the cap

and stopper from one lyophilized human plasma control vial and
remove the cap from one vial of calcium chloride reconstituting
fluid.
2 Pour the entire contents of the calcium chloride vial into the
lyophilized human plasma control vial. Place the stopper back
in the reconstituted control vial, sealing the vial appropriately so
that the contents do not leak or spill out.
3 Allow the vial to sit at room temperature for 1 minute.
4 Mix the contents of the vial by swirling gently for 1
minute, then inverting slowly for 30 seconds.
Note: To minimize foaming of the control sample, avoid vigorous
or rapid mixing motion. Visually inspect the control vial to ensure
that the sample is fully reconstituted. If not, discard and start
over with fresh vials.
5 Using a plastic transfer pipette, plastic syringe, or plastic capillary
tube with no anticoagulant, immediately transfer the solution
from the vial into the PT/INR cartridge.

14-8 Art: 714376-01C Rev. Date: 07/12/04

 6 Immediately seal the cartridge and insert it into an analyzer.
Note: Additional PT/INR cartridges may be tested with
the remaining fluid if used within 30 seconds of complete
reconstitution of the sample.

Control Target Target values (determined by testing multiple vials of each level using multiple
Values and Expected lots of i-STAT cartridges with analyzers that have passed the Electronic Simulator
Ranges test) are printed on a value assignment sheet included in each box of control
vials. The ranges displayed represent the maximum deviation expected when
controls and cartridges are performing properly. Should results outside the
range be obtained, refer to the Troubleshooting portion of this section of the
i-STAT System Manual (page 14-17). Always be sure that the lot number printed
on the value assignment sheet matches the lot number on the label of the vial
in use, and that the software revision above the table matches the software
revision in the analyzer (check the status page on the analyzer).

Note: Target values are specific to the i-STAT System; results obtained from these
reconstituted control plasmas may differ if used with other methods.

CONTROLS FOR cTnI CARTRIDGES

Intened Use i-STAT® Cardiac Markers Controls are assayed human sera used to verify the
integrity of newly received i-STAT cTnI cartridges.

Warnings and Handle this product using the same safety precautions used when handling any
Precautions potentially infectious material. The human sera used in the preparation of this
product have been tested by FDA approved test methods and found negative/
non-reactive for HIV-1, HIV-2, HBsAg, HCV, HTLV-1 and HTLV-2. However, no
known test method can offer complete assurance that products derived from
human blood will not transmit infectious disease.

Each vial contains < 0.1% sodium azide as a preservative. Dispose of this product
according to all local, state and national regulations. If disposed down a drain,
the sodium azide in this product may react with lead and copper plumbing to
form highly explosive metal azides. Flush drain with large amounts of water
to prevent azide build-up.

Do not use if the controls arrive thawed or uncapped.

Bacterial contamination can cause an increase in turbidity. Do not use the control
if there is visible evidence of microbial growth or gross contamination.

Storage and Stability Store at ≤ –18oC (-1 oF) in a non-defrosting freezer. After thaw, the opened or
unopened vial is stable for 4 hours when capped and stored at 2-8oC (35-46
o
F). Do not re-freeze.

Procedure
Step Action
1 Remove vial from freezer and thaw at room temperature (18-30°C) for 15 minutes.
2 Thoroughly mix by gently swirling the bottle. Avoid foaming of the sample.
3 Dispense a drop of sample directly from vial into the i-STAT cTnI cartridge and seal the
cartridge. Tightly recap the bottle immediately after all sampling is complete and store at
2-8°C.
4 Insert cartridge into an i-STAT analyzer.

Art: 714376-01C Rev. Date: 07/12/04 14-9

Control Target See accompanying value assignment sheet. The value assignment sheet displays
Values and Ranges target values and ranges expected when controls and equipment are performing
properly. Should results fall outside the range, refer to the System Manual.

Always ensure that the lot number and software revision on the value
assignment sheet matches the lot number of the vial in use and the software
revision in the analyzer.

Target values are specific to the i-STAT System. Results may differ if used with
other methods.

PERFORMING ELECTRONIC SIMULATOR TEST

Procedure for The internal Electronic Simulator test cycle is automatically activated when a
Internal Electronic cartridge is inserted after the customized interval is reached. If the analyzer
Simulator passes the simulator test, the cartridge test cycle proceeds. If not, the analyzer
displays “ELECTRONIC SIMULATOR FAIL.” If the analyzer is customized
to block testing when it fails the simulator test, the same cartridge can be
re-inserted immediately after the FAIL message is displayed. If the analyzer
fails the simulator test again, see the Troubleshooting section that follows the
Procedure. If less than three minutes has elapsed, the cartridge can be inserted
into another analyzer. If the analyzer is not customized to block testing after
a failed simulator test, the internal simulator test will not repeat until the
programmed interval has elapsed.

14-10 Art: 714376-01C Rev. Date: 07/12/04

PROCEDURE FOR EXTERNAL ELECTRONIC SIMULATOR

Analyzer Response /
Display Step
Comments
Press the On/Off key to turn the Logo briefly displayed followed
analyzer on. by Test Menu.
Test Menu Press the Menu key.
Administration Menu Press 3 to select Quality Tests.
Quality Tests Menu Press 4 to select Simulator.
Scan or Enter Press Scan to scan the Operator If enabled, the analyzer will
Operator ID ID or manually enter the Operator validate ID and/or ask for the ID
ID and press Enter. to be repeated.
Scan or Enter Simulator ID Press Scan to scan the Simulator The simulator serial number
ID or manually enter the Simulator can be used as an ID. If the
ID and press Enter. simulator does not have a
barcode, one can be made on-
site and affixed to the simulator
(not near contact pads).
INSERT SIMULATOR Remove the cover protecting Inserting the simulator at an
the contact pads and insert the angle may cause a Quality Check
simulator straight into the analyzer. message to be displayed.
Avoid touching the contact pads.
Contacting Simulator Do not attempt to remove the
Please wait… simulator until the results are
Time to Results bar displayed and the “Simulator
Locked” message is removed.
Simulator Locked
Result screen: Test Options If PASS is displayed, continue
ID of Simulator Simulator to use the analyzer. Remove
the simulator and return it to its
Date and Time 1 - Next Simulator protective case.
ELECTRONIC 2 - Same Simulator If FAIL is displayed, see the
SIMULATOR PASS or 3 - History Troubleshooting in this section
FAIL of the manual.
1 - Test Options

Caution
The analyzer will continue to initialize test cycles when the analyzer is
customized to warn, but not block testing when a scheduled external Electronic
Simulator test is missed, when a FAIL result for the external Electronic Simulator
test is ignored, and when the analyzer fails the internal Electronic Simulator
test and the lockout feature is not enabled.

Art: 714376-01C Rev. Date: 07/12/04 14-11

TROUBLESHOOTING FAILED ELECTRONIC SIMULATOR TEST

Introduction With both the internal and external Electronic Simulator, an analyzer may
occasionally fail a simulator test even though it is in proper operating condition
due to the extremely sensitive nature of the test.

External Simulator Run the test again or try another simulator, as it is possible that the test will
pass on a second try. The test can also fail if the external Electronic Simulator
is malfunctioning such as after being dropped.

Occasionally when an analyzer is moved from a cold environment to a warm,

humid environment, moisture may condense on the internal connector. An
analyzer in this condition will fail the electronic test and the failure code “L” will
be displayed. Allow the analyzer to sit for half an hour to allow the moisture
to evaporate, then insert the Electronic Simulator again. If the analyzer passes
the second electronic test, continue using it. If the analyzer fails the second
time, record the letter or Quality Check Code displayed with the FAIL message
and refer to Support Services information in the Troubleshooting section.

Internal Simulator The cartridge or an external Electronic Simulator should be rerun to confirm
the failure. The analyzer’s connector pins are in contact with the biosensor
chips in the cartridge being tested when the internal Electronic Simulator test is
being performed. The test can fail if the contact pads have been contaminated
in some way.

Lockout Enabled: Rerun the cartridge in the same analyzer to ensure the
FAIL was not due to a one-time spike of electrical noise. If the test fails again,
rerun the cartridge in another analyzer if immediately available. Note that the
cartridge should not be run if there is more than a three minute delay from the
time it is filled. If the cartridge fails in more than one analyzer, use another
cartridge. When Lockout is enabled, the analyzer will continue to perform
the internal Electronic Simulator test each time a cartridge is inserted until the
test (internal or external) passes.

Lockout Not Enabled: Rerun the cartridge in another analyzer if immediately

available. Note that the cartridge should not be run if there is more than a
three minute delay from the time it is filled. When Lockout is not enabled, the
analyzer will run the next cartridge without performing the internal Electronic
Simulator test until the specified time has elapsed. Verify the analyzer using
an external Electronic Simulator.

14-12 Art: 714376-01C Rev. Date: 07/12/04

CHECKING THE THERMAL PROBES IN THE I-STAT ANALYZERS

Verification for Verify the thermal probe check for the i-STAT Portable Clinical Analyzer and i-
Handheld Analyzers STAT1 Analyzer as follows:

• External Electronic Simulator used routinely and results transmitted

to a Central Data Station Version 4: On the CDS, click on System,
then on Simulator Results. Look under the Delta column. Check
that there is a value equal to or less than 0.1 (≤ 0.1) listed for each
analyzer in use in the last 30 days. A value of “--.--” indicates that
the conditions to complete the thermal probe check were not met.
Use the procedure below to check any analyzer that does not have a
numeric value listed.
• External Electronic Simulator used routinely and results transmitted
to a Central Data Station Version 5: On the CDS, click on Data
Viewer, then on Simulator. Look under the Probe Delta column.
Check that there is a value equal to or less than 0.1 (≤ 0.1) listed for
each analyzer in use in the last 30 days. A value of “--.--” indicates
that the conditions to complete the thermal probe check were not
met. Use the procedure below to check any analyzer that does not
have a numeric value listed.
• External Electronic Simulator used routinely, results not transmitted
to a Central Data Station: Use the procedure below to check the
thermal probes on each analyzer twice a year.
• Internal Electronic Simulator used routinely: Use the procedure
below to check the thermal probes on each analyzer twice a year.

Procedure for Check the thermal probes on the i-STAT Portable Clinical Analyzer and i-STAT1
Handheld Analyzers Analyzer as follows:

1. If the analyzer and simulator have been stored separately in areas

where the ambient temperature differs by more than 3°C (5°F), allow
the simulator and analyzer to stand in the same place, out of drafts,
for 30 minutes before inserting the simulator into the analyzer.
Handle the simulator as little as possible to maintain its thermal
uniformity and stability.
2. Insert the simulator into the analyzer.
3. When results are displayed, the difference between the thermal
probes can be viewed on the analyzer’s screen:

• Portable Clinical Analyzer: while holding down the DIS key, press
the 1 key.
• i-STAT 1 Analyzer: press the period key.

4. Interpretation of the thermal probe check value:

• Acceptable: a value equal to or less than 0.1 (≤ 0.1)

• Not acceptable: a FAIL message with a “t” Quality Check Code or
a value greater than 0.1. Repeat the procedure to confirm results.
Contact your Technical Support representative if the repeat thermal
check value is greater than 0.1.
• Repeat the procedure: if “--.--” is displayed. Take care to handle
the simulator a little as possible. It may help to partially insert the
simulator into the analyzer and let it stand for 15 minutes before
inserting all the way.
Art: 714376-01C Rev. Date: 07/12/04 14-13
Verification of BAMs Verify the thermal probe check on a Philips Medical System Blood Analysis
Module (BAM) and Central Data Station Version 5 as follows:

• External Electronic Simulator used daily and results transmitted to a

Central Data Station Version 5: On the CDS, click on Data Viewer,
then on Simulator. Click on Record in the Main Menu, then click
on Extended Electronic Simulator Report. Look under the Pot6P
column. Check that there is a value equal to or less than 0.1 (≤ 0.1)
listed for each BAM in use in the last 30 days. No recorded value
indicates that the conditions to complete the thermal probe check
were not met. Use the procedure below to check any BAM that does
not have a numeric value listed.
• Internal Electronic Simulator used routinely: Use the procedure
below to check the thermal probes on each BAM twice a year.

Procedure for BAMS Check the thermal probes on a BAM as follows:

1. Insert the simulator partially into the BAM and wait for 15 minutes
before inserting the simulator all the way into the BAM. Handle the
simulator as little as possible to maintain its thermal uniformity and
stability.
2. When results are displayed, transmit the results to the Central Data
Station.
3. View the probe check value on the CDS:

1) Click on Data Viewer

2) Click on Simulator
3) Click on Record in the Main Menu task bar
4) Click on Extended Electronic Simulator Report
5) Look under the Pot6P column
4. Interpretation of the thermal probe check value:

• Acceptable: a value equal to or less than 0.1 (≤ 0.1)

• Not acceptable: a FAIL message with a "t" Quality Check Code or a
value greater than 0.1. Repeat the procedure to confirm the results.
Contact your Technical Support representative if the repeat thermal
check value is greater than 0.1.
• No value: repeat the procedure. Take care to handle the simulator
as little as possible. It may help to increase the time in step 2 to 30
minutes.
Documentation of
Results The results of the The results of thermal probe check are stored in the Central
Data Station. If the Central Data Station is not available, use the form included
with this Technical Bulletin to record the results.

14-14 Art: 714376-01C Rev. Date: 07/12/04

PROCEDURE TO CHECK AMBIENT TEMPERATURE
Place the analyzer in a room with a calibrated thermometer suspended near
the analyzer and away from air currents for one hour. Check the temperature
reading on the Analyzer Status page under the Administration Menu. The
temperature reading should be ± 1 °C of the thermometer’s reading.

PERFORMING CONTROL TEST ON CARTRIDGE

Procedure for Testing Initiating control tests from the Quality Test Menu allows results to be stored
Controls in separate categories for the purpose of documentation and review.

NOTE:
Analyzer Response /
Display Step
Comments
Hematronix Meter Trax
controls must be tested Press the On/Off key. Logo briefly displayed followed
using this control path by Test Menu.
and not as a patient
sample.
Test Menu Press the Menu key.
Administration Menu Press 3 to select Quality Tests.
Quality Tests Press 1 to select Control.
1 – Control
2 – Proficiency
3 – Cal Ver
4 – Simulator
Quality Tests Control Press 1 to select i-STAT
1 – i-STAT Cartridge Cartridge.

2 – PCx Glucose Strip

Scan or Enter Operator ID Press Scan to scan the Operator If enabled, the analyzer will
ID or manually enter the Operator validate the ID. If enabled, the
ID using the keypad and press analyzer will prompt for the ID to
Enter. be repeated.
Scan or Enter Control Lot Press Scan to scan the Control
Number Lot Number or manually enter
the Lot Number using the keypad
and press Enter.
Scan or Enter Cartridge Press Scan to scan the Cartridge
Lot Number Lot Number or manually enter
the number using the keypad and
press Enter.
INSERT CARTRIDGE The analyzer will display INSERT
CARTRIDGE for 15 minutes (or
a customized timeout, whichever
is greater) before turning off.
Identifying Cartridge Do not attempt to remove the
Please wait… cartridge while the “Cartridge
Cartridge Locked Locked” message is displayed.

Art: 714376-01C Rev. Date: 07/12/04 14-15

PERFORMING CONTROL TEST ON CARTRIDGE (CONTINUED)

Analyzer Response /
Display Step
Comments
i-STAT (Cartridge panel If enabled, the Chart page will be
number) displayed automatically. If not,
Time to Results press the  kewy to go to the
Chart page if necessary.
 Page
Cartridge Locked
Control (lot number) Scan or manually enter the Operator Test Selection is not
Scan or Enter Data control level (such as 1, 2 or 3) enabled for control tests.
and press Enter. Tests disabled in customization
Control Level _
The screen has three fields with will not be displayed.
Field 1 --------- capacity for 9 characters each. Information entered on the Chart
Field 2 --------- These fields can be used for and Test Selection page can be
additional information. Press the changed up until:
Field 3 ---------
Enter key to move from field to
field and to edit. Use the  key • the next test is initiated.
 Page to backspace and erase entered • results are transmitted.
characters.
• the Menu key is used to
Cartridge Locked backup to the Test Menu
screen.
• a Test Option is selected.
Results Test Options The “Cartridge Locked” message
1-Test Options Control is removed and the cartridge
may be removed.
1 - Next Level
2 - Repeat Level
3 - History

14-16 Art: 714376-01C Rev. Date: 07/12/04

TROUBLESHOOTING OUT-OF-RANGE CONTROL RESULTS ON CARTRIDGE

Troubleshooting Verify that the following conditions are met and then repeat the test:

• The correct expected values insert is being used and the correct
cartridge type and lot number listing is being used.
• Expiration date printed on cartridge pouch and control ampule or
vial have not been exceeded.
• Room temperature expiration date for cartridge and control have not
been exceeded.
• Cartridge and control have been stored correctly.
• The control has been handled correctly: See the directions for use.
• The analyzer being used passes the Electronic Simulator test.

If the results are still out of range despite meeting the above criteria, repeat the
test using a new box of control solutions and/or cartridges. If the results are
still out of range, refer to Support Services information in the Troubleshooting
section.

CONTROLS FOR GLUCOSE TEST STRIP

Control Solutions Use only Precision™, Precision·G®, or MediSense® Control Solutions to verify
the performance of the Precision PCx and PCx Plus Test Strips and the test
strip reading function of the analyzer. Controls contain a known amount of
glucose.

Storage Control Solutions should be stored at temperatures between 4 and 30 °C (39

to 86 °F).

Do not use control solutions after the expiration date printed on the bottles
and the box. The analyzer does not accept control solutions that have passed
their expiration date.

Each bottle of control solutions is stable for 90 days after opening if cap is
replaced tightly after each use. Discard all unused solutions 90 days after
opening.

Directions for Use When opening a new bottle, write the current date on the bottle label.

Invert the control solution bottle several times to ensure thorough mixing
before use.

Invert and tap the capped control solution bottle to remove air bubbles from
the nozzle of the bottle.

Replace the cap on the bottle and tighten the cap immediately after each
use.

Barcode Do not scan one test strip packet’s barcode and use a test strip from another
packet. This may cause incorrect assay results to be generated.

Art: 714376-01C Rev. Date: 07/12/04 14-17

RECOMMENDATIONS FOR GLUCOSE TEST STRIPS
When to Test • Daily.
Controls
• When you question blood glucose results.
• When you adjust diabetes medication plans.
• When your test strips have been exposed to temperatures outside the
storage conditions (39°-86 °F, 4°-30 °C).
• When you open a new lot of test strips.

PERFORMING CONTROL TEST WITH GLUCOSE STRIP

Procedure If the analyzer displays a message not indicated in this procedure, refer to
Troubleshooting Section of this Manual.

Caution Allow the analyzer to remain completely horizonal while testing controls to
prevent control fluids from running into the test strip port.

Analyzer Response /
Display Step
Comments
Press the On/Off key. Logo briefly displayed followed
by Test Menu.
Test Menu Press the Menu key. Controls can also be run from
the test menu.
Administration Menu Press 3 to select Quality Tests.
Quality Tests Press 1 to select Control.
1 – Control
2 – Proficiency
3 – Cal Ver
4 – Simulator
Quality Tests Control Press 2 to select PCx Glucose Test
1 – i-STAT Cartridge Strip.

2 – PCx Glucose Strip

Scan or Enter Operator ID Press Scan to scan the Operator If enabled, the analyzer will
ID barcode, or manually enter the validate the ID. If enabled, the
Operator ID via the keypad and analyzer will prompt for the ID to
press Enter. be repeated.
Scan or Enter Low Level Scan or manually enter the Low The analyzer expects controls
Control Lot Number Level Control Solution Lot Number to be tested in order of Low,
via the keypad and press Enter. Mid (if enabled), High. If
the Unexpected Level screen
appears, press 1 - Re-enter
to enter the correct level lot
number, or press 2 to continue to
test the unexpected level.
Scan or Enter Strip Lot Scan or manually enter the Test Messages that can be enabled in
Number Strip Lot Number. Customization: Invalid Number,
Invalid Length, Lot Expired.

14-18 Art: 714376-01C Rev. Date: 07/12/04

PERFORMING CONTROL TEST WITH GLUCOSE STRIP (CONTINUED)

Analyzer Response /
Display Step
Comments
INSERT STRIP Open the foil test strip packet at The analyzer will display INSERT
the notch and tear up or down to CARTRIDGE for 15 minutes (or
remove the test strip. a customized timeout, whichever
With the contact bars facing up, is greater) before turning off.
insert the test strip into the test
strip port until it stops.
Apply Low Control Gently invert the control solution The analyzer beeps when the
Sample bottle 3-4 times then apply a drop sample is accepted. Recap the
to the target area on the test strip. control solution bottle tightly.
Sample Accepted
Precision PCx Blood If Auto-Chart is enabled, the There are three free field lines,
Glucose Strip Chart page will be displayed each of which can accept up to 9
Time to Results automatically. The Chart page can characters.
be displayed by pressing the right The analyzer counts down 20
 Page arrow key. seconds then displays the test
result.
Results Test Options Results are displayed as PASS
1 – Test Options Control or FAIL (according to the
ranges encoded in the test strip
lot number or programmed
1 – Next Level into the analyzer through the
Customization function on
2 – Repeat Level
the Central Data Station) and
3 – History numerically.
If Comment Code is enabled, the
analyzer will request the operator
to Scan or Enter a Comment
Code. Up to 3 characters can be
entered.
Remove Strip Repeat the procedure for the Mid
Level Control, if enabled, and the
High Level Control.
If the Next Test option is
selected, the analyzer will prompt
for the High Control (or Mid
Control if enabled.)

Art: 714376-01C Rev. Date: 07/12/04 14-19

TROUBLESHOOTING OUT-OF-RANGE RESULTS ON TEST STRIPS

Troubleshooting Repeat the test for that control solution and verify that the following conditions
are met:

• No air bubbles are in the control bottle’s nozzle.

• Calibrate the monitor using the barcode for the test strip used.
• Enter the correct 5-digit lot number for the control solution.
• Check storage temperatures: Solutions and test strips must be stored
between 39 °F and 86 °F (4 °C and 30 °C).
• Check that the temperature and humidity conditions in the room
where the tests are being performed are within the acceptable
operating range.
• Check that the bottles have not been opened for more than 90 days.
• Use a new test strip for each test.
• Use only Precision PCx or PCx Plus Test Strips.

If test results are out of range despite meeting the above criteria, repeat the test
using a new box of control solutions and/or test strips. If results are still out of
range refer to Support Services information in the Troublshooting section.

14-20 Art: 714376-01C Rev. Date: 07/12/04

 i-STAT System Incoming Cartridge QC Log
CatridgeType:____________ Lot No.:____________ Rec’d Date:____________ Exp. Date:____________ Quat:______________ Temp. Strip*:______________

Art: 714376-01C
Control Name: _________________________ Level: ________________ Lot No.: _________________ Exp. Date: _______________
TEST TEST TEST TEST TEST TEST TEST TEST
RANGE RANGE RANGE RANGE RANGE RANGE RANGE RANGE

Control Name: _________________________ Level: ________________ Lot No.: _________________ Exp. Date: _______________
TEST TEST TEST TEST TEST TEST TEST TEST
RANGE RANGE RANGE RANGE RANGE RANGE RANGE RANGE

Rev. Date: 07/12/04

Control Name: _________________________ Level: ________________ Lot No.: _________________ Exp. Date: _______________
TEST TEST TEST TEST TEST TEST TEST TEST
RANGE RANGE RANGE RANGE RANGE RANGE RANGE RANGE

Control Name: _________________________ Level: ________________ Lot No.: _________________ Exp. Date: _______________
TEST TEST TEST TEST TEST TEST TEST TEST
RANGE RANGE RANGE RANGE RANGE RANGE RANGE RANGE

14-21
14-22 Art: 714376-01C Rev. Date: 07/12/04
 i-STAT System QC Log: Expiration Date and Storage Conditions
REFRIGERATED REFRIGERATED
2 TO 8° C (35 TO 46° F) 2 TO 8° C (35 TO 46° F)

CARTRIDGE EXP. EXP.

Art: 714376-01C
DATE LOCATION LOT # QTY TEMP QTY TEMP ACTIONS INSP.
TYPE DATE DATE

Rev. Date: 07/12/04

14-23
14-24 Art: 714376-01C Rev. Date: 07/12/04
 i-STAT Cartrdige Quality Control Action Log
CONTROL CONTROL CARTRIDGE
DATE TIME PROBLEM CORRECTIVE ACTION OPERATOR
LEVEL LOT LOT

Art: 714376-01C
Rev. Date: 07/12/04
14-25
14-26 Art: 714376-01C Rev. Date: 07/12/04
 i-STAT Analyzer PCx and PCx Plus Glucose Test Strip QC Log
IF FAIL
CONTROL CONTROL STRIP PASS
DATE TIME EXPECTED RESULT ACTION OPERATOR
LEVEL LOT LOT FAIL
RANGE

Art: 714376-01C
Rev. Date: 07/12/04
14-27
14-28 Art: 714376-01C Rev. Date: 07/12/04
 i-STAT Electronic Simulator Log for Analyzer Serial Number:________________ Year:_________

PASS SIMULATOR PASS SIMULATOR PASS SIMULATOR

DATE TIME OPERATOR TIME OPERATOR TIME OPERATOR
FAIL ID FAIL ID FAIL ID

Art: 714376-01C
Rev. Date: 07/12/04
14-29
14-30 Art: 714376-01C Rev. Date: 07/12/04
 i-STAT Electronic Simulator Action Log
FAILURE CODE
DATE TIME ANALYZER SIMULATOR ID ACTION OPERATOR
OR LETTER

Art: 714376-01C
Rev. Date: 07/12/04
14-31
14-32 Art: 714376-01C Rev. Date: 07/12/04
 i-STAT Analyzer Thermal Probe Check Year: ________
Analyzer Serial No.: ________________________
THERMAL PROBE DELTA RESULT
DATE SIMULATOR SERIAL NO. COMMENTS OPERATOR
(LIMIT: ± 0.1° C)

Art: 714376-01C
Analyzer Serial No.: ________________________
THERMAL PROBE DELTA RESULT
DATE SIMULATOR SERIAL NO. COMMENTS OPERATOR
(LIMIT: ± 0.1° C)

Analyzer Serial No.: ________________________

Rev. Date: 07/12/04

THERMAL PROBE DELTA RESULT
DATE SIMULATOR SERIAL NO. COMMENTS OPERATOR
(LIMIT: ± 0.1° C)

Analyzer Serial No.: ________________________

THERMAL PROBE DELTA RESULT
DATE SIMULATOR SERIAL NO. COMMENTS OPERATOR
(LIMIT: ± 0.1° C)

14-33
 CALIBRATION VERIFICATION 15
NOTE: IN COUNTRIES WHERE LABORATORY REGULATIONS DO NOT REQUIRE ROUTINE
LINEARITY CHECKS, i-STAT DOES NOT RECOMMEND THIS PROCEDURE,
BELIEVING IT TO BE UNNECESSARY FOR A FACTORY CALIBRATED SYSTEM.

CALIBRATION VERIFICATION FOR BLOOD GAS/ELECTROLYTE/METABOLITE CARTRIDGES

Purpose Calibration Verification is a procedure intended to verify the accuracy of
results over the entire measurement range of a test. The performance of this
procedure at defined intervals may be required by regulatory or accreditation
bodies. While the Calibration Verification Set contains five levels, verification
of the measurement range could be accomplished using the lowest, highest
and mid levels.

Overview of i-STAT recommends that each sensor type be included in the Calibration
Procedure Verification procedure using a selection of the analyzers that have passed the
Electronic Simulator check. See the Technical Bulletin "Calibration Verfication
and the i-STAT System" for more information.

Calibration A five-level Calibration Verification Set is available to verify the calibration

Verification Solutions of i-STAT cartridges throughout the reportable ranges for:
for Cartridges
Sodium pH Glucose
Potassium PCO2 Lactate
Chloride PO2 BUN/Urea
Ionized Calcium Creatinine

There are four 1.7mL glass ampules of each level in the set.

Reactive Ingredients See the table on page 14-3 of the Quality Control section for full
information.

Storage Refrigerated storage at 2 to 8 °C (35 to 46°F) should be maintained until the

printed expiration date on the box and ampule labels. Calibration Verification
fluids may also be stored at room temperature for up to 5 days (18 to 30 °C or
64 to 86°F). Prolonged storage at temperatures greater than 30 °C (86°F) may
cause changes in the values of some analytes. Do not use beyond the expiration
date on the box and ampule labels.

Ampule Use When using cartridges that contain sensors for pH, PCO2, PO2 and ionized
calcium, a separate ampule must be used for each cartridge being tested. If
these sensors are not present, the contents of one ampule may be used to fill
more than one cartridge as long as the cartridges are filled and inserted into
an analyzer within 10 minutes of opening the ampule.

Best Results For best results, ampules, cartridges and analyzers should be at the same
temperature.

Art: 714377-01D Rev. Date: 01/25/05 15-1

i-STAT CALIBRATION VERIFICATION SET
Before Use i-STAT Calibration Verification solutions require different temperature
stabilization times depending on whether or not oxygen is to be measured. If
oxygen is to be measured, equilibrate the ampule to room (ambient) temperature
for 4 hours. If not, equilibrate the ampule to room (ambient) temperature for
30 minutes.

Procedure STEP ACTION

1 Immediately before use, shake the ampule vigorously for 5 to 10

seconds to equilibrate the liquid and gas phases. To shake, hold
the ampule at the tip and bottom with forefinger and thumb to
minimize increasing the temperature of the solution. If necessary,
tap the tip of the ampule to send solution back into the bottom
section of the ampule.

2 Protect fingers with gauze, tissue or glove, or use an ampule breaker

to snap off the tip of the ampule at the neck.

3 Immediately transfer the solution from the ampule into a plain

capillary tube or plain syringe, and then immediately transfer the
solution into a cartridge.

4 Immediately seal the cartridge and insert it into an analyzer – it

is important not to expose the solution to room air since this will
alter the results.

Note: Since aqueous based solutions such as controls lack the buffering
capabilities of whole blood, the transfer process from ampule to cartridge
must be more expedient than with a patient sample.

Transfer with Plain capillary tubes are recommended to transfer aqueous calibration
Capillary Tube verification material from the ampule to the cartridge. When using a capillary
tube (fresh capillary tubes with sufficient fill capacity are recommended), fill
from the bottom of the ampule.

Avoid drawing solution from the surface by placing a finger over the far end
of the tube as it is inserted into the ampule.

Once the open end of the tube rests at the bottom of the ampule, uncover the
other end to allow filling by capillary action.

Transfer with Plain syringes are recommended to transfer aqueous calibration verification
Syringe material from the ampule to the cartridge. When using a syringe (fresh 1cc or
3cc sterile syringes with 16 - 20 gauge needles are recommended), slowly draw
approximately 1mL of solution from the bottom of the ampule.

If air is trapped between the leading edge of the solution and the plunger, do
not invert the syringe to expel it; this will not affect solution near the front
of the syringe.

If air bubbles are continually drawn into the syringe, or if a bubble is trapped
near the tip of the syringe, discard the ampule and syringe and use a fresh
ampule and syringe.

Expel one or two drops from the syringe before filling the cartridge.

15-2 Art: 714377-01D Rev. Date: 01/25/05

Acceptable Criteria Target values (determined by testing multiple ampules of each level using
multiple lots of i-STAT cartridges with analyzers that have passed the Electronic
Simulator test) and acceptable ranges are printed on a Value Assignment Sheet
included with each Calibration Verification Set.

Calibration throughout the reportable range of each analyte is verified if each

analyte value falls within the corresponding range in the Value Assignment
Sheet.

If the result for a level is outside the range published in the Value Assignment
Sheet, two additional cartridge runs should be performed on this level and the
three results averaged and then compared to the Value Assignment Sheet range.
If this average value is still outside the acceptable range, troubleshooting may
be required.

Note: If the Calibration Verification Set is to be used to assess linearity, plot

the analyte value against the mean value of the acceptable range. The
concentrations of analytes in the Calibration Verification Set are not
intended or prepared to be equally spaced.

If testing at extreme altitude refer to Correction of PO2 at Extreme Altitude

under Controls for Blood Gas/Electrolyte/Metabolite Cartridges in the Quality
Control section of the manual.

Art: 714377-01D Rev. Date: 01/25/05 15-3

i-STAT CARDIAC MARKER CALIBRATION VERIFICATION SET
A three level Calibration Verification Set is available to verify the calibration
of cTnI cartridges throughout the reportable range.

These are two 1.0 mL plastic vials of each level in the set.

Intended Use i-STAT® Cardiac Markers Calibration Verification Controls are assayed human
sera used to verify the calibration of the cTnI test throughout the reportable
range.

Warnings and Handle this product using the same safety precautions used when handling any
Precautions potentially infectious material. The human sera used in the preparation of this
product have been tested by FDA approved test methods and found negative/
non-reactive for HIV-1, HIV-2, HBsAg, HCV, HTLV-1 and HTLV-2. However, no
known test method can offer complete assurance that products derived from
human blood will not transmit infectious disease.

Each vial contains < 0.1% sodium azide as a preservative. Dispose of this product
according to all local, state and national regulations. If disposed down a drain,
the sodium azide in this product may react with lead and copper plumbing to
form highly explosive metal azides. Flush drain with large amounts of water
to prevent azide build-up.

Do not use if the controls arrive thawed or uncapped.

Bacterial contamination can cause an increase in turbidity. Do not use the control
if there is visible evidence of microbial growth or gross contamination.

Storage and Stability Store at ≤ –18°C (-1°F) in a non-defrosting freezer. After thaw, the opened or
unopened vial is stable for 4 hours when capped and stored at 2-8°C (35-46°F).
Do not re-freeze

Procedure
Step Action
1 Remove vial from freezer and thaw at room temperature (18-30°C) for 15 minutes.
2 Thoroughly mix by gently swirling the bottle. Avoid foaming of the sample.
3 Dispense a drop of sample directly from vial into the i-STAT cTnI cartridge and seal the
cartridge. Tightly recap the bottle immediately after all sampling is complete and store at
2-8°C.
4 Insert cartridge into an i-STAT analyzer.

Control Target See accompanying value assignment sheet. The value assignment sheet displays
Values and Ranges target values and ranges expected when controls and equipment are performing
properly. Should results fall outside the range, refer to the System Manual.

Always ensure that the lot number and software revision on the value
assignment sheet matches the lot number of the vial in use and the software
revision in the analyzer.

Target values are specific to the i-STAT System. Results may differ if used with
other methods.

15-4 Art: 714377-01D Rev. Date: 01/25/05

VERIFICATION PROCEDURE FOR HEMATOCRIT
Preparation of 1. Draw 4 lithium heparin green top tubes from a fasting person with a
Hematocrit Samples normal hematocrit or MCHC. 7mL vacuum tubes are suggested. Label
the tubes 1, 2, 3, and 4.
2. Centrifuge tubes 3 and 4 for 10 minutes at 3,000 rpm to pack the
cells.
3. Remove two thirds the volume of whole blood from tube 1. This
blood should be held in a clean plain tube in case it is needed to
make adjustments later.
4. Transfer all of the plasma from tube 4 to tube 1.
5. Remove three fourths of the plasma from tube 3. This plasma
should be held in a clean plain tube in case it is needed to make
adjustments.
6. Gently invert tubes 1, 2 and 3 to resuspend the cells.
7. Measure the hematocrit of the blood in tubes 1, 2, and 3 using one
cartridge for each tube. Adjust the hematocrit in tube 1 until it reads
close to, but not less than, 10%. Adjust the hematocrit in tube 3 until
it reads close to, but not more than, 75%.

Measurement 1. Gently invert tubes 1, 2, and 3 to resuspend the cells.

2. Measure the hematocrit of the blood in tubes 1, 2, and 3 three times
each by the i-STAT and microcentrifuge methods.
3. Inspect the data for outliers. Repeat a measurement if necessary.
4. Calculate the mean of the three measurements of the three
hematocrit levels for both methods.

Interpretation of The i-STAT hematocrit method using blood anticoagulated with lithium
Results heparin is calibrated to give results equivalent to the reference microhematocrit
method using blood anticoagulated with K3EDTA. Since the blood used for the
microhematocrit determination here is anticoagulated with lithium heparin,
adjustment must be made to the observed i-STAT values to compensate for the
anticoagulant difference.

1. To calculate the adjusted i-STAT hematocrit mean, multiply the mean

of the observed i-STAT results by 1.0425.
2. The adjusted i-STAT hematocrit mean should be within ±3%PCV of
the microhematocrit mean.
For example: the microhematocrit method mean for the mid level
sample is 36%PCV. The i-STAT method mean is 34%PCV. 34 x
1.0425 = 35.445. Acceptable range for the adjusted i-STAT mean: 33
- 39%PCV.

Note: If your analyzers are customized for K2EDTA/Heparin/None, the above

calculation is unneccessary.

Notes on the 1. If a higher hematocrit value is needed in tube 1 or 3, packed cells can
Procedure be obtained by centrifuging the whole blood retained from tube 1 in
step 3. If a lower hematocrit value is needed, add plasma retained in
step 5.

Art: 714377-01D Rev. Date: 01/25/05 15-5

 2. The highest hematocrit that should be tested on the i-STAT System is
75%. Whole blood samples with hematocrit values greater than 75%
will be flagged as >75. The lowest hematocrit that should be tested
on the i-STAT System is 10%. Whole blood samples with hematocrit
values less than 10% will be flagged as <10.

Using Another Methods other than the reference microhematocrit procedure may be used to
Comparative Method verify calibration and reportable range of the i-STAT hematocrit. However, the
following requirements apply:

• Blood should be drawn from a fasting donor with a normal

hematocrit and a normal MCHC (calculated from hemoglobin and
hematocrit values determined using reference methods) and be free
of specific interferences which degrade the accuracy and/or precision
of the alternative comparative method or the i-STAT method.
• Calculation of results must correct for any systematic bias between
the reference microhematocrit method and the alternative
comparative method selected.

Reference Method NCCLS recommends that the blood samples anticoagulated with Na2EDTA
or K2EDTA be used for the microhematocrit method.* However, EDTA will
interfere with the electrolyte measurements which are used in the calculation
of hematocrit results on the i-STAT System.

* NCCLS. Procedure for Determining Packed Cell Volume by the Microhematocrit

Method; Approved Standard– Third Edition. NCCLS document H7-A3 (ISBN 1-
56238-413-9). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2000.

VERIFICATION PROCEDURE FOR ACT

See Technical Bulletin: i-STAT Celite and i-STAT Kaolin ACT Heparin Linearity
Procedure

15-6 Art: 714377-01D Rev. Date: 01/25/05

Procedure for Initiating Calibration Verification tests from the Quality Tests menu allows
Cartridges results to be stored in separate categories for the purpose of documentation
and review. Also, measurement limits are not applied to results in this test path.
Therefore, results below and above the measurement ranges will be reported.

Display Action Analyzer Response

Press the On/Off key. Logo briefly displayed followed

by Test.
Test Menu Press the Menu key.
Administration Menu Press 3 to select Quality Tests.
Quality Tests Press 3 to select Cal Ver.
1 – Control
2 – Proficiency
3 – Cal Ver
4 - Simulator
Quality Tests Cal Ver Press 1 to select i-STAT
1 – i-STAT Cartridge Cartridge.

2 – PCx Glucose Strip

Scan or Enter Operator ID Press Scan to scan the If enabled, the analyzer will
Operator ID or manually enter validate the ID. If enabled, the
the Operator ID using the analyzer will prompt for the ID to
keypad and press Enter. be repeated.
Scan or Enter Cal Ver Kit Lot Press Scan to scan the Kit Lot Note: The Calibration Verification
Number Number or enter the Kit Lot Kit is not barcoded and does not
Number using the keypad and have a Kit Lot Number. Each level
press Enter. has its own lot number. Enter the
If a new Lot Number is entered, lot number of Level 1 as the Kit
the message “New Panel Will Lot Number.
Replace Old Panel” will be The analyzer stores the lot number
displayed with two options: of the kit in use.
1 – ReEnter When a new kit lot number is
2 – Replace Panel entered, the counter for all levels
will be set to zero.
Press 1 to re-enter the lot
number or 2 to replace the old
lot number with the new lot
number.
Select Level Enter the number of the level to The analyzer tracks how many
1 - Level 1 (0) be tested. replicates of each level are tested.

2 - Level 2 (0) Selecting 6 – Reset resets the

counters for all levels back to zero.
3 - Level 3 (0)
Up to 4 replicates of each level can
4 - Level 4 (0) be tracked.
5 - Level 5 (0)
6 - Reset

Art: 714377-01D Rev. Date: 01/25/05 15-7

 Scan or Enter Cartridge Lot Press Scan to scan the Lot
Number Number or manually enter the
Cartridge Lot Number using the
keypad and press Enter.
INSERT CARTRIDGE Operator Test Selection is not
Identifying Cartridge Please enabled for calibration verification
wait… tests.

Cartridge Locked Tests disabled in customization

will not be displayed.
i-STAT (Cartridge panel If enabled, the Chart page will
number) be displayed automatically. If
Time to Results not, press the → key to go to
the Chart page if necessary.
→ Page
Cartridge Locked
Results Test Options The “Cartridge Locked” message
1-Test Options Cal Ver is removed and the cartridge may
be removed.
1 - New Level
2 - Same Level
3 - History

Troubleshooting See Troubleshooting Out-of-Range Results for Cartridges paragraph in the

Cartridge Tests Performing Control Tests on Cartridges section of this manual.

15-8 Art: 714377-01D Rev. Date: 01/25/05

LINEARITY/CALIBRATION VERIFICATION TEST FOR TEST STRIPS
Linearity Solutions Use the linearity kit supplied by Abbott. Instructions and acceptance criteria are
for Test Strips included in the kit’s package insert. Use the Precision PCx or PCx Plus values
in the package insert for the strip reader in the i-STAT 1 Analyzer. The kit is
not validated for use with cartridges. If the Point-of-Care Central Workstation
includes a QC Manager Application, it will analyze the data.

Procedure for Test Initiating linearity tests from the Quality Tests menu allows results to be stored
Strips in separate categories for the purpose of documentation and review.

Caution Allow the analyzer to remain completely horizontal while testing aqueous
solutions to prevent solutions from running into the test strip port.

Display Action Analyzer Response

Press the On/Off key. Logo briefly displayed followed

by Test.
Test Menu Press the Menu key.
Administration Menu Press 3 to select Quality Tests.
Quality Tests Press 3 to select Cal Ver.
1 – Control
2 – Proficiency
3 – Cal Ver
4 - Simulator
Quality Tests Cal Ver Press 2 to select PCx Glucose
1 – i-STAT Cartridge Strip.

2 – PCx Glucose Strip

Scan or Enter Operator ID Press Scan to scan the If enabled, the analyzer will
Operator ID or manually enter validate the ID. If enabled, the
the Operator ID using the analyzer will prompt for the ID to
keypad and press Enter. be repeated.
Scan or Enter Cal Ver Kit Lot Press Scan to scan the Kit Lot The analyzer stores the lot number
Number Number or enter the Kit Lot of the kit in use.
Number using the keypad and Entering a new kit lot number will
press Enter. automatically reset the counters
If a new Lot Number is entered, for each level to zero.
the message “New Panel xxx
Will Replace Old Panel xxx”
will be displayed with two
options:
1 – ReEnter
2 – Replace Panel
Press 1 to re-enter the lot
number or 2 to replace the old
lot number with the new lot
number.

Art: 714377-01D Rev. Date: 01/25/05 15-9

LINEARITY/CALIBRATION VERIFICATION TEST FOR TEST STRIPS (CONTINUED)

Select Level Enter the number of the level to The analyzer tracks how many
1 - Level 1 (0) be tested. replicates of each level are tested.

2 - Level 2 (0) Selecting 6 – Reset resets the

counters for all levels back to zero.
3 - Level 3 (0)
Up to 4 replicates of each level can
4 - Level 4 (0) be tracked.
5 - Level 5 (0)
6 - Reset
Scan or Enter Strip Lot Scan the Strip Lot Number or
Number enter the number using the
keypad and press Enter.
INSERT STRIP Open the foil test strip packet at
the notch and tear up or down
to remove the test strip.
With the contact bars facing up,
insert the test strip into the test
strip port until it stops.
Apply Cal Ver Sample Follow the manufacturers The analyzer beeps when the
instructions for mixing the sample is accepted. Recap the
sample, and then apply a drop solution bottle tightly.
to the target area.
Precision PCx Blood If Auto-Chart is enabled, the There are three free field lines,
Glucose Strip Chart page will be displayed each of which can accept up to 9
Time to Results automatically. The Chart page characters.
can be displayed by pressing The analyzer counts down 20
→ Page the → key. seconds then displays the test
result.
Results Test Options Repeat the procedure for replicates
1 – Test Options Cal Ver of the same level or for additional
levels.
1 - New Level
2 - Same Level
3 - History
Remove Strip

Troubleshooting See the Troubleshooting Out-of-Range Results on Strips paragraph in the Quality
Strip Tests Control section of this manual.

15-10 Art: 714377-01D Rev. Date: 01/25/05

 PROFICIENCY or EXTERNAL QUALITY CONTROL TESTING 16
Purpose Samples from external quality control providers can be used to assess consistency
of results for a particular method or system across testing sites. Due to matrix
effects and additives, these samples should not be used as an indication of the
system’s true accuracy.

General Procedure Initiating Proficiency Tests from the Quality Tests menu allows results to be
stored in separate categories for the purpose of documentation and review.
Proficiency samples should be tested in the same way as patient samples.

The same CLEW is used for the patient test path and the Proficiency test path.
However, in the proficiency test path hematocrit results are calculated using
coefficients for K3EDTA even if the analyzer is customized for K2EDTA. This
ensures that hematocrit results are consistent across all sites. Also, if star-outs
occur frequently when using the patient sample test path to test proficiency or
external quality control samples, they might be avoided by using the proficiency
test path.

Procedure For
Cartridges Display Action Analyzer Response

Press the On/Off key. Logo briefly displayed followed

by Test.
Test Menu Press the Menu key.
Administration Menu Press 3 to select Quality Tests.
Quality Tests Press 2 for Proficiency.
1 – Control
2 – Proficiency
3 – Cal Ver
4 - Simulator
Quality Tests Proficency Press 1 for i-STAT Cartridge.
1 – i-STAT Cartridge
2 – PCx Glucose Strip
Insert Cartridge
Scan or Enter Press Scan to scan the If enabled, the analyzer will
Operator ID Operator ID or manually enter validate the ID. If enabled, the
the number using the keypad analyzer will prompt for the ID to
Cartridge Locked and press Enter. be repeated.
Do not attempt to remove the
cartridge while the “Cartridge
Locked”message is displayed.
Scan or Enter Proficiency ID Press Scan to scan the An ID of up to 15 characters can
Proficiency ID or manually be entered.
enter the characters that identify
the sample and press Enter.

Art: 714378-01B Rev. Date: 06/13/03 16-1

Procedure For
Cartridges Display Action Analyzer Response
(continued)
Scan or Enter Cartridge Lot Press Scan to scan the Lot This screen is displayed if this
Number Number or manually enter the option is enabled for patient
Lot Number and press Enter. testing.
Test Selection screen If Test Selection is enabled,
select the tests to be reported.
i-STAT (Cartridge panel If the Chart page is not
number) automatically displayed, press
Time to Results the → key to enter information
on the chart page.
→ Page
Cartridge Locked
ID Enter information if desired. Note: For consistency across
Scan or Enter Data Use the Enter key to move sites, it is recommended that NO
from field to field. be selected for CPB.
Sample Type _
For CPB the choices are: Note: CPB is included on the
Field 1 --------- screen only when the cartridge
1 – YES and 2 – NO. Default
Field 2 --------- is NO. includes a sensor for hematocrit.
Field 3 --------- Use the → key to return to the Information entered on the Chart
results page and Test Selection pages can be
Pt Temp -----
changed up until:
FIO2 ---
• the next test is initiated.
CPB NO
• results are transmitted.
• the Menu key is used to
1- ART 4- CAP
backup to the Test Menu
2- VEN 5-CORD screen.
3- MIX 6-OTHR • a test option is selected.

→ Page
Cartridge Locked
Results Enter a Comment Code if Tests disabled in customization
Comment requested. will not be displayed.

1 -Test Options Test Options The “Cartridge Locked” message

Proficiency is removed and the cartridge may
be removed.
1 - Next Sample
2 - Same Sample
3 - History

16-2 Art: 714378-01B Rev. Date: 06/13/03

Troubleshooting The i-STAT System is designed to measure fresh whole blood samples. Matrix
effects and interfering substances can be expected when measuring non-whole
blood samples. The following points should be considered when selecting and
testing external quality control samples:

• Aqueous samples intended to assess blood gases will not be measured

by the i-STAT System unless electrolytes, or at least sodium, are
present.
• Fluorocarbon samples are not compatible.
• Preserved-cell samples, other than Meter Trax (Hematronix, Inc)
whole blood controls for glucose and hematocrit, are not compatible.
(The i-STAT System will report only hematocrit for Meter Trax
controls.)
• Aged serum and lyophilized serum may contain degradation products
or preservatives that interfere with the measurements.
• Matrix effects between aqueous-based and protein-based samples
may cause results from the i-STAT System to differ from reference
methods or other comparative methods.
• Aqueous samples that contain a resistive substance to allow
assessment of conductometric hematocrit measurements will cause
the i-STAT System to extrapolate ambient temperature results to 37
°C results for ionized calcium, pH and PCO2 as if the sample were
whole blood. Since extrapolation coefficients for aqueous and whole
blood samples differ, results on the i-STAT System for these samples
may not agree with other methods.

While the various cartridges give the same results for whole blood samples, there
may be small differences between generations and types of cartridges for non-
whole blood samples. Generation means major manufacturing changes such as
making the chips smaller. Cartridge types means those that make measurements
at ambient temperature and those that make measurements at 37 °C.

Administrative errors include choosing the wrong method or peer group and
transcription errors.

Art: 714378-01B Rev. Date: 06/13/03 16-3

Procedure for Test
Strips Display Action Analyzer Response

Press the On/Off key Logo briefly displayed followed by

Test Menu.
Test Menu Press the Menu key
Administration Menu Press 3 for Quality Tests
Quality Tests Press 2 for Proficiency
1 – Control
2 – Proficiency
3 – Cal Ver
4 - Simulator
Quality Tests Proficiency Press 2 for PCx Glucose Strip
1 – i-STAT Cartridge
2 – PCx Glucose Strip
Scan or Enter Press Scan to scan the In enabled, the analyzer will
Operator ID. Operator ID or manually enter validate the ID. If enabled, the
using the keypad and press analyzer will prompt for the ID to
Enter. be repeated.
Scan or Enter Proficiency Press Scan to scan the An ID of up to 15 characters can
ID Proficiency ID or manually be entered.
enter the characters that identify
the sample and press Enter.
Scan or Enter Strip Press Scan to scan the Strip Possible messages:
Lot Number Lot Number or manually enter “Lot Expired”,
the Strip Lot Number using the
keypad and press Enter. “Invalid Number”,
“Invalid Length”,
“Strip Lot xxx Is Not in List”
Select Sample Type: Press 1 or 2 to select the For consistency across sites,
1 – Arterial or Capillary correct sample type. select:

2 - Venous 1-Arterial or Capillary.

INSERT STRIP Open the foil test strip packet at

the notch and tear up or down
to remove the test strip.
With the contact bars facing up,
insert the test strip into the test
strip port until it stops.
Apply Proficiency Sample Follow the directions for use for The monitor beeps when the
the sample. sample is accepted The test starts
Apply a drop of sample directly automatically as the sample is
from the bottle or transfer accepted.
device to the target area on the
test strip.

16-4 Art: 714378-01B Rev. Date: 06/13/03

Procedure for Test
Strips (continued) Display Action Analyzer Response

Precision PCx Blood Enter Chart page information if The analyzer counts down 20
Glucose Strip desired. seconds, then displays the test
Time to Results result.

→ Page If the → key is pressed, the

Chart page will be displayed. The
sample type will be displayed
along with 3 free fields in which
comments of 9 characters each
can be entered.
The analyzer may be customized
to present the Chart page
automatically.
Results Remove the strip from the If Action Ranges are enabled, an
1 – Test Options analyzer when finished testing. up (high) or down (low) arrow will
Test Options be displayed with the result.

Proficiency If Comment Code is enabled, the

analyzer will request the operator
to Scan or Enter Comment Code.
1 - New Sample Up to 3 characters can be entered.
2 - Same Sample
3 - History

Art: 714378-01B Rev. Date: 06/13/03 16-5

 ROUTINE CARE of the ANALYZER and DOWNLOADER 17
Drying a Wet If the analyzer is placed on a wet surface or if any liquid is spilled onto it, dry
Analyzer or the analyzer immediately. If liquid enters the following compartments, the
Downloader analyzer may be damaged:

 The electronics compartment

 The battery compartment
 The cartridge port
 The test strip port

The Downloader may also be damaged by liquid contamination. Unplug the

power supply from the outlet and dry the Downloader completely.

Cleaning the Clean the display screen and the case using a gauze pad moistened with any
Analyzer and of the following:
Downloader
 A mild non-abrasive cleaner
 Detergent
 Soap and water
 Alcohol
 10% bleach solution
 PDI Super Sani-Cloth (solution of IPA, n-Alkyl dimethyl
ethylbenzyl- and benzyl- ammonium chloride)

Rinse the case using another gauze pad moistened with water and dry. Avoid
getting excess fluids in the seam between the display screen and the case.

(PDI and Sani-Cloth are registered trademarks of Sani-System™ Brand Products,

the Health Care Division of Nice-Pak Products, Orangeburg, NY, USA.)

Caution Exercise universal safety precautions at all times when handling the
analyzer, cartridges, and peripherals to prevent exposure to blood-born
pathogens.

The analyzer is NOT designed to be sterilized or autoclaved by any method,

including those using gas (e.g. steam, ethylene oxide, ect...) high heat, bead,
radiation, or other chemical processes. The analyzer is splash resistant, but
should not be immersed in any liquids.

Dispose of analyzer, peripheral electronics, and batteries according to local,

state, and/or national guidelines.

If the analyzer is not to be used for an extended period of time, the batteries
should be removed to prevent leakage.

Decontaminate the analyzer or Downloader whenever a specimen is spilled

onto it or if the item is to be returned to i-STAT for repair. Wear gloves while
performing the following procedure.

Art: 714379-01D Rev. Date: 07/12/04 1

Procedure STEP ACTION

1 Prepare a 1:10 solution of household bleach by mixing one part of

bleach with nine parts of tap water. This solution will maintain
its germicidal action for a week.
2 Soak a few gauze pads in the bleach solution. Before use, squeeze
the pads to remove excess solution.
3 Soften, then remove any dried blood with one or two of the gauze
pads soaked in the bleach solution. Avoid scraping dried blood
as contaminated particles may become airborne.
4 Clean the entire surface of the device twice with gauze pads soaked
in the bleach solution.
5 Rinse the surface of the device with gauze pads moistened with
tap water and dry.
6 If the device is to be shipped, place it in a plastic bag.

Removing Wait until any test in progress is completed, and turn off the analyzer before
and Replacing replacing the batteries or the most recent set of results may be lost. Stored
Disposable Batteries results will not be lost when replacing the batteries.

STEP ACTION

1 Slide the battery compartment door off.

2 Tilt the analyzer slightly to slide out the battery carrier which
contains the two 9-volt batteries.
3 Remove the old batteries from the carrier. Pull each battery out
to the side and then lift back and out.
4 Note the battery orientation symbol molded into the carrier on
each side of the center wall. Starting with one side, orient the
new battery so it matches the symbol. Slide the battery into the
carrier, pushing the terminal end in first, under the plastic bar,
and slide it up as far as it will go. Then push the bottom of the
battery inward. The terminals of the battery should be underneath
the protective bar on the carrier. Repeat for the second battery
on the other side of the carrier.
5 Note the orientation of the battery carrier illustrated on the label
on the carrier. The label faces up, and the electrical contact end
of the carrier goes into the instrument first. Insert the carrier into
the instrument as shown on the label. If the carrier is inserted
incorrectly, the battery door will not close.
6 Slide the battery compartment door back into place.

Caution A falling instrument may cause injury. Place the instrument on a flat and stable
surface at all times to ensure the instrument does not fall.

2 Art: 714379-01D Rev. Date: 07/12/04

Removing and Wait until any test in progress is completed, and turn off the analyzer before
Replacing the replacing the battery or the most recent set of results may be lost. Stored results
Rechargeable will not be lost when replacing the batteries.
Battery

STEP ACTION

1 Slide the battery compartment door off.

2 Tilt the analyzer slightly to slide out the rechargeable battery
pack.
3 The battery pack has two labels: one for orientation in the analyzer
and one for orientation in the Downloader/Recharger. With the
label with the analyzer facing up, and the electrical contact end of
the pack facing the analyzer, insert the pack into the analyzer as
shown on the label. If the pack is inserted incorrectly, the battery
door will not close.
4 Slide the battery compartment door back into place.

Art: 714379-01D Rev. Date: 07/12/04 3

4 Art: 714379-01D Rev. Date: 07/12/04
 UPDATING THE SOFTWARE 18
CLEW The i-STAT System is designed to eliminate operator influence on delivered
results. Unlike other unit-use systems, the user is not required to enter lot-
specific calibration information into the instrument. The micro-fabricated
sensor technology produces very repeatable devices from lot to lot which
allow the Analyzers to use the same set of standardizing values for extended
periods of time.

Nevertheless, the continuous manufacturing process improvements by

i-STAT necessitate re-establishing standardization values from time to time to
maintain long-term consistency. This is equivalent to adjusting calibration
on a traditional analyzer. New CLEW re-establishes the standardization and
incorporates refinements to the internal quality monitoring system.

Application Software The “Application” software, listed under Version on the Analyzer Status page,
is updated to enable the analyzer to recognize new cartridges and to enable
new features. These updates typically occur at the same time as the CLEW
updates.

Software Updates Software update packages are mailed to each site three times a year
and approximately two months before the current CLEW expires. The
package includes a diskette with new versions of CLEW or both CLEW and
application software, a Product Update explaining any changes, directions
for updating software, and new value assignment sheets for control solutions.
The procedure for updating software includes transferring the new software
from the diskette to the Point-of-Care Central Workstation, updating one or
a few analyzers from the Workstation, and updating other analyzers around
the facility from the ones updated at the Workstation. A PC with Windows
95 or higher can be used in place of the Point-of-Care Central Workstation.
Note: The COM ports of certain laptops may need to be reconfigured
to communicate with the Downloader. If communication cannot be
established, a standard PC should be used.

Art: 714380-01C Rev. Date: 07/12/04 18-1

UPDATING ANALYZER SOFTWARE: JAMMLITE UTILITY
The JammLite Utility must be used to update software in the i-STAT®1 Analyzer
and can be used to update the i-STAT Portable Clinical Analyzer and the Blood
Analysis Module. The JammLite procedure is simple with just one screen for all
analyzer types and software versions.

To use this utility, you must have a computer with Windows ® 95 or

higher. An i-STAT Central Data Station Version 5 or a Point of Care Central
Workstation meet this requirement and can be used. An i-STAT/DE server is not
recommended for use with this utility.

If this is the first time you are updating your analyzer, follow the Detailed
Procedure. If you just need reminders, follow the Summary of the Procedure.

SUMMARY OF THE PROCEDURE

HOW TO STEP PAGE

Check battery voltage
1 18-3
Save the data on Portable Clinical Analyzers
Disable Customization on the Central Data
2 18-3
Station
Shut down all programs on the computer 3 18-3
Connect an IR Link or Downloader* to the
4 18-4
computer
Access the C:\> prompt 5 18-5
Transfer the files from the JAMS disk to the
6 18-5
computer
Access the JammLite Utility 7 18-6
Select the instrument (analyzer) type to be
7 18-6
updated
Select the local port or select TCP\IP and enter
7 18-6
the IP address
Select the Application software and CLEW 7 18-6
Click on Update and follow the directions on the
7 18-6
screen
DO NOT move analyzer during update 7 18-7
Click on Close 7 18-7
Click on Exit or X in upper right corner of screen 7 18-7
Re-start the CDS, update CLEW, re-eanable
8 18-7
Customization
Insert an Electronic Simulator into each updated
9 18-7
analyzer

* It is not neccessary to connect a serial Downloader if using network

protocol to update i-STAT 1 Analyzer.

18-2 Art: 714380-01C Rev. Date: 07/12/04

DETAILED PROCEDURE

Step Action

Step (1) Save Stored Results & Check Battery Voltage

Save Data: All test records are erased in the i-STAT Portable Clinical Analyzer
(series 200) when the application software is updated. Download each analyzer
to the Central Data Station (CDS) program or ensure that all test records have
been transcribed before updating a Portable Clinical Analyzer. Test records are
not erased from the i-STAT1 Analyzer (series 300).

• There are two types of software in the analyzers: application (JAMS)

and CLEW.
• The Product Update lists the software that is to be updated.
• Test records will not be erased if only the CLEW software is updated.

Check Battery Voltage: Analyzers consume power during the software

update. For the software update, the battery voltage should be well above
the 7.5 V point at which the low battery message is displayed.

Step (2) Disable Customization on CDS

If you do not use Customization and Customization is disabled, skip this step.
If you are not sure if Customization is disabled, follow the steps below. The
steps to disable customization differ for the Central Data Station Version 4 and
Central Data Station Version 5. If you are not sure which CDS you have, click
Help on the main menu bar, then click on About....

Central Data Station Version 4:

1. Click on the i-STAT Analyzer Customization Profile Utility icon or
access by clicking Programs and i-STAT CDS.
2. Type in the Password. The default password is istat.
3. Click on File on the menu bar.
4. Click on Disable Customization.
5. Click Yes to the confirmation messages and the Utility will close.

Central Data Station Version 5:

1. Click on Administration in the main menu bar.
2. Click on Customization.
3. Type in the Password. The default password is istat.
4. Click off the checkmark in the box beside Enable Customization at
the top left of the window.

Step (3) Shut Down All Programs

Exit the CDS and all other open programs.

Art: 714380-01C Rev. Date: 07/12/04 18-3

Step (4) Connect the IR Link and/or Downloader
IR Link connection:
• If using a Central Data Station Version 5, a Central Data Station
Version 4 with digiboard, or any other computer using Windows 95
or above, connect the IR Link to a 9 pin COM port using an i-STAT
Software Update Kit as illustrated below.

• If using a Central Data Station Version 4 with quad cards: Connect

the IR Link to COM5 on the back of the CDS using a Modular Data
Cable (i-STAT grey flat cable with RJ45 connectors). COM5 is first
port from the inside on the lower row.

Blood Analysis Module connection:

• If using a Central Data Station Version 4, connect the BAM to COM5
on the back of the CDS using a Modular Data Cable (i-STAT grey flat
cable with RJ45 connectors).
• If using a Central Data Station Version 5 or another computer,
connect the BAM to a 9 pin COM port using the D-Connector and
Mini Din Connector from an i-STAT Software Update Kit.

Note: Do not connect the BAM until instructed to do so by the JammLite

program.

18-4 Art: 714380-01C Rev. Date: 07/12/04

 Serial Downloader connection:
• Connect a serial Downloader to a COM port using a DB9-DB9 Null
Modem cable and plug the Downloader’s power adapter into a wall
outlet.

Network Downloader connection:

• Connect a network Downloader to the network using a network
patch cable and plug the Downloader’s power adapter into a wall
outlet. The computer must also be connected to the network. The
computer must support the TCP/IP network protocol.

Step (5) Access the Command Prompt

• Click Start in the lower left corner of the window.
• Click Run.
• Type: command and press the Enter key.

Note: If you do not have access to the Run command, contact your Point-
of-Care Coordinator or Information Technology (IT) department.

Step (6) Transfer the Files

Place the JAMS diskette into the A:drive. At the Command prompt, type
A:transfer and press the Enter key.

Art: 714380-01C Rev. Date: 07/12/04 18-5

Step (7) Using the JammLite Utility
1. At the C:\>bins prompt, type jammlite and press the Enter key. The
following screen will be displayed with the new application and
CLEW.

X.X is the current version of JammLite software.

2. Select the appropriate instrument from the Instrument drop-down

list.

Note: i-STAT 200 Analyzer is the Portable Clinical Analyzer and the i-STAT
300 Analyzer is the i-STAT 1 Analyzer.

3. Select the port for the instrument being updated from the “Port”
drop-down list. The JammLite program will list only available ports
on the computer. For updates using a network Downloader, select
TCP/IP. (The TCP/IP option is available only if i-STAT 300 is selected
from the “Instrument” drop down list.) Enter the IP address of the
Downloader in the “IP Address” box.
4. Select the appropriate Application and CLEW from the Application
and CLEW drop-down lists. Refer to the update package for the
correct Application and CLEW. If the update is for CLEW only,
select None for Application. Note that there are different application
versions for the i-STAT 1 Analyzer, the Portable Clinical Analyzer and
the Blood Analysis Module. JammLite will display all application
software and CLEW appropriate for the selected instrument.
5. Click on the Update button to start the update. Appropriate
instructions will be displayed. Follow the directions on the screen.
The selected application and CLEW will be displayed on the Update
Line.
18-6 Art: 714380-01C Rev. Date: 07/12/04
 6. During the update, do not move the analyzer or unplug the Blood
Analysis Module until a screen is displayed indicating the update was
successful.
7. Click on Close. The JammLite program will return to step 7 to allow
any selections to be changed before starting another update.
8. When all analyzers have been updated, click on Exit or the X in the
upper right corner of the DOS window.

Step (8) Restarting the Central Data Station

If using a Central Data Station, re-start the software, update the Customization
Profile(s) with the new CLEW and enable Customization if desired.

Central Data Station Version 4:

1. Click on the i-STAT Analyzer Customization Profile Utility icon or
access by clicking Programs and i-STAT CDS.
2. Type in the Password. The default password is istat.
3. Click on Setup Mode.
4. Click on NEXT for the Language window.
5. Click on the new CLEW in the CLEW window and click on NEXT.
6. Click on NEXT in the Unit Set window.
7. Click on FINISH in the Preference window.
8. Click on FILE and Exit Program or click on the x in the upper right
corner of the Utility window.
9. Click on the Central Data Station icon.

Central Data Station Version 5:

1. Click on the Central Data Station icon.
2. Click on Administration.
3. Click on Customization.
4. Type in the Password. The default password is istat.
5. Click the i-STAT Analyzer CLEW button.
6. Click the new version of CLEW and click OK.
7. If “Use Default Profile” is not check-marked beside any localization-
based customization profiles, double click the box with the CLEW
under the i-STAT Analyzer column (or Agilent BAM CLEW) and
click the new version of CLEW.
8. Click a checkmark in the box beside Enable Customization at the top
left of the window.
9. Click the x in the upper right corner of the Customization window
to close it.

Step (9) Verifying the Update

Run an external Electronic Simulator on updated analyzers and check the
Analyzer Status page for the new Application software and/or CLEW.

Art: 714380-01C Rev. Date: 07/12/04 18-7

TROUBLESHOOTING

PROBLEM RECOMMENDED ACTION

The Com port to be used for the Exit the JammLite program and ensure
update is not listed in the Port List that there are no other programs
running which may be using the port
(such as the Central Data Station).
Restart the JammLite program to
determine if the port is now listed.
A message appears on the screen that Verify that no other programs are using
the port specified for the update could the port and that the correct port was
not be opened. selected.
A message appears on the screen that Verify that all other programs are
the specified application file could not closed and that the proper application
be opened, has an error, or is not a was selected before re-attempting the
valid application file. update.
A message appears on the screen that Verify that the IR Link is connected to
the IR Link could not be configured to the COM port, that the LED on the IR
perform the application update. Link is red, and that the proper port is
selected.
A message appears on the screen that Ensure that the instrument is located
there was an error encountered during properly in the IR Link or Downloader,
communication with the analyzer. and this it is not removed before the
update is completed.
A message appears on the screen that Ensure that all other programs are
the specified CLEW file could not be closed and that the correct CLEW
opened, has an error, or is not a valid is selected before re-attempting the
CLEW file. update.
A message appears on the screen that Verify that the IR Link is connected to
the IR Link could not be configured to the COM port, that the LED on the IR
perform the CLEW update. Link is red, and that the proper port is
selected.
A message appears on the screen Verify that the Downloader is
that the Downloader could not be connected to the COM port, the
configured to perform the update Downloader is powered, and that the
proper port is selected.
A message appears on the screen Select an Application and/or a CLEW
indicating that nothing was selected prior to clicking on the Update button.
for the update.

Quality Check Code If this quality check code occurs after successfully downloading new software
13 - Invalid or Expired and restoring on-line customization, the CLEW has not been updated
CLEW after on-line to the new version in the Customization Profile. Update CLEW in the
customization is customization profile(s) and download the analyzers. The new CLEW will be
restored installed in the analyzers.

Unsuccessful with Some computers with Windows 95 will not run JammLite. In this case,
Windows 95 Jammit must be used to update analyzers. Before accessing the Jammit
Utility, the computer must be rebooted.

18-8 Art: 714380-01C Rev. Date: 07/12/04

ANALYZER-TO-ANALYZER SOFTWARE UPDATES

i-STAT 1 Analyzer Step Action

1 Any updated analyzer can be used as the sending analyzer. Select

the Utility option under the Administration Menu on the sending
analyzer. The Utility menu can be password protected. Enter the
password or press the Enter key if no password has been specified.
From the Utility Menu select 1-Send Software. Select 1 – JAMS and
CLEW or 2-CLEW as required for the update. The message “Waiting
to Send” will be displayed.

2 Ensure that the receiving analyzer is off.

3 Place the sending and receiving analyzers facing each other on a flat
surface about 30cm (1 foot) apart and align their IR windows. Move
one analyzer toward the other until the message “Sending…” is
displayed on the sending analyzer and a scrolling banner appears on
the receiving analyzer.

4 Do not move the analyzers until the “Sending…” message is removed

from the sending analyzer’s display. The sending analyzer will return
to the Send Software option and will display the result of the last
software update as “Successful” or “Unsuccessful.”

5 Select the Analyzer Status option under the Administration menu on

the receiving analyzer and check that the new JAMS and/or CLEW are
listed.

Art: 714380-01C Rev. Date: 07/12/04 18-9

i-STAT Portable Step Action
Clinical Analyzer
1 Any updated analyzer can be used as the Sending Analyzer. Run the
external Electronic Simulator on the Sending Analyzer.

2 Transmit all data from the analyzer being updated (the Receiving
Analyzer) to the Central Data Station. Data stored in the handheld
analyzer will be lost after an application software update.

3 With the Simulator test results showing on the display of the

Sending Analyzer, press and hold the DIS key and press the soft key
for MENU. This displays the Utility Menu.

4 In the Utility Menu, select 3 - Send Software. The display will

show the JAMS version and the CLEW in this analyzer. Verify that
these are the appropriate versions. The analyzer screen will also say
"Waiting to send".

5 Set both analyzers on a flat surface and align the Infrared Light-
Emitting Diode (IR LED) windows so they directly face each other.
(Refer to the analyzer picture on page 2-1 of the i-STAT System
Manual for the location of the IR LED.)

6 On the Receiving Analyzer, make sure the display is off. Press

and hold the * key and press the DIS key. The Sending Analyzer
will begin sending software to the Receiving Analyzer. The display
on the Sending Analyzer will change from "Waiting to send" to
"Sending...", and a countdown bar will be displayed.

Note: Do not move the analyzers while the software is being sent.

7 When the display of the Sending Analyzer changes back to the

Electronic Simulator result, the sending of software is complete. Do
not press the DIS key on the Receiving Analyzer. Run the Electronic
Simulator on the Receiving Analyzer.

8 To update software in another analyzer, repeat these instructions

from Step 2.

i-STAT is a registered trademark of i-STAT Corporation.

Windows is a registered trademark of Microsoft Corporation.

18-10 Art: 714380-01C Rev. Date: 07/12/04

 TROUBLESHOOTING THE ANALYZER 19
Introduction When the analyzer detects a potential or real problem before the test cycle is
initiated or at any time during the test cycle, a Quality Check Code number,
the type of problem and the next step to be taken will be displayed. The Code
number may be helpful to a technical support representative if a problem cannot
be resolved. If a problem cannot be resolved by the procedures described in this
section, refer to Support Services information in the Troubleshooting section.

Note: Troubleshooting for results and quality tests are covered in those sections
of this manual.

Note: The Technical Bulletin “Analyzer Coded Messages” included in this

manual lists the Quality Check Code numbers as well as additional
troubleshooting details

Caution DO NOT OPEN THE ANALYZER, or any other i-STAT product, or perform any
unauthorized procedures. Opening any i-STAT product, including analyzer,
Electronic Simulator, printer or communication device, in attempt to repair
it or resolve a problem may cause erroneous results. If the troubleshooting
procedures found in this manual or requested by an i-STAT support specialist do
not resolve the problem, the product must be returned to i-STAT for repair.

Information Needed Have the following pertinent information available for review with the
representative:

• Description of problem
• When problem first occurred and what has been done so far to
resolve the problem
• Serial number of component(s)
• Displayed message and code number
• Frequency of problem
• Software version
• Environmental conditions
• Result of last Electronic Simulator test
• Battery voltage from Analyzer Status page

Art: 714381-01C Rev. Date: 07/12/04 19-1

STARTUP MESSAGES
Overview Whenever the analyzer is turned on using the On/Off key, the analyzer performs
self-checks. If a condition that should be corrected in the near future, but that
will not affect results is detected, a warning is displayed. The operator presses
the 1 key to continue with testing. If the analyzer has been customized to disable
testing under any of these conditions, the condition must be corrected and
the analyzer turned off and back on before testing will be enabled.

Message on Display Explanation How to Respond

Electronic Simulator Test Analyzer customized to alert Insert the external Electronic
Required the operator that a scheduled Simulator at the earliest
simulator test is due. convenient time.
PCx Glucose Strip Control Analyzer customized to alert the Test the controls at the earliest
Required operator that scheduled control convenient time.
tests are due.
Stored Memory Low Memory space for 50 unsent Place the analyzer in a
test records available before the Downloader.
“Stored Memory Full” message
is displayed.
Stored Memory Full The analyzer is customized Place the analyzer in a
to alert the operator that the Downloader.
memory for unsent records
is full. If the operator does
not transmit the test records
to the Point-of-Care Central
Workstation, the analyzer will
either block further testing or
will overwrite oldest records
depending on how the analyzer
is customized.
Upload Required The analyzer is customized Place the analyzer in a
to alert the operator that a Downloader.
scheduled transmission of test
records to the Central Data
Station is due.
Battery Low Battery voltage has dropped Change the disposable lithium
to 7.4 volts. There is sufficient batteries or recharge the
power to test a few more rechargeable battery.
cartridges and strips, the
number depending mainly on
the types of cartridges in use.
Under this condition, a flashing
battery icon will also appear on
the result page.
CLEW Expiring, Upgrade Message appears 15 days Update the analyzer before the
Required before the software expires. expiration date.

19-2 Art: 714381-01C Rev. Date: 07/12/04

TEST CYCLE MESSAGES AND QUALITY CHECK CODES
Overview If a problem is detected during a testing cycle, the cycle will be stopped and a
message will identify the problem and indicate the next step to be taken. If the
problem causes testing to be disabled, the problem must be corrected and the
analyzer must be turned off and back on before testing will be enabled.

Environmental The following messages usually indicate a condition related to the environment
Conditions or the state of the analyzer. These conditions are usually benign and go away
after the the offending condition is corrected.

Message on Display Cause Action

Date Invalid, Check Clock The analyzer will not allow a Press Menu once to go to the Test
date that precedes or exceeds Menu and then again to go to the
the six months lifetime of the Administration Menu. Press 5
CLEW software. to go to the Set Clock screen and
correct the date.
Dead Batteries, Replace There is insufficient battery Change the disposable lithium
Batteries power to complete a test cycle. batteries or recharge the
rechargeable battery.
Temperature Out of Range, The analyzer makes a Check the temperature reading
Check Status Page temperature measurement on the Analyzer Status screen
before initiating a test cycle. (under the Administration Menu).
If below the operating range,
move to a warmer area. If above
the operating range, move to a
cooler area. Allow time for the
analyzer to equilibrate to the new
temperature. Check the Analyzer
Status screen periodically.
Invalid or Expired CLEW The software has become Verify that the date in the analyzer
corrupt or has expired. The is correct. Change the software
Product Update for each if expired. Update the software
software update includes the again if not expired. If the
expiration date. message is displayed again, refer
to Support Services information at
the end of this section.
Analyzer Interrupted, Use The analyzer detected that Check that the battery pack
Another Cartridge the last cartridge run was not is inserted properly. Turn the
completed. This can happen analyzer on and check for the
if battery voltage is low, or Low Battery message; replace or
if batteries were removed or recharge if needed.
making poor contact while
a cartridge was still in the
analyzer.

Art: 714381-01C Rev. Date: 07/12/04 19-3

Error in Cartridge or The following conditions usually indicate an error condition relating in some
Fluid Movement way to the cartridge or fluid movement within a cartridge. These conditions
can be operator or sample related. In most cases a new cartridge must be used.
If a condition persists, especially if isolated to one analyzer, there may be an
analyzer problem.

Message on Display Cause Action

Cartridge Error These codes can all be Use another cartridge.

Use Another Cartridge caused by a variety of reasons If the same code repeats more than
including sample-related twice, there may be an analyzer
problems, users, cartridges or problem. Try another analyzer if
analyzers. Single or sporadic available.
errors are most likely a sample-
related problem (an interferent),
an aberrant cartridge, or a
user-induced situation such
as touching cartridge contacts,
pressing on center of cartridge
or bubbles in the sample
(“frothy” samples).
Cartridge Preburst This code indicates that the Try another cartridge.
Use Another Cartridge analyzer detected fluid on the Make sure that the cartridges were
sensors before it should have. not frozen.
Possible causes:
• Cartridges may have been
frozen.
• Calibrant pack may have
been burst by operator
exerting too much pressure
on the center of the
cartridge.
Unable to Position Sample The analyzer did not detect Use another cartridge.
Use Another Cartridge movement of sample across the
sensors. This could be due to:
• not closing the snap closure
on the cartridge.
• a clot in the sample
preventing movement of the
sample.
• an aberrant cartridge.
Sample Positioned Short of The cartridge was under-filled. The sample must reach the fill
Fill Mark mark. Try another cartridge.
Use Another Cartridge
Sample Positioned Beyond The cartridge was overfilled. The sample was past the fill mark.
Fill Mark Try another cartridge.
Use Another Cartridge

19-4 Art: 714381-01C Rev. Date: 07/12/04

Error in Cartridge
or Fluid Movement Message on Display Cause Action
(continued)
Insufficient Sample This is most likely due to Try another cartridge.
Use Another Cartridge insufficient sample in the
sample well of the cartridge,
but can also be caused by
bubbles in the sample.
Cartridge Not Inserted The code indicates the cartridge Reinsert the cartridge or Electronic
Properly or external Electronic Simulator Simulator. If problem is recurrent
Reinsert Cartridge may not be pushed in all the and/or the user is certain the
way. cartridge or Simulator is properly
inserted, it may indicate an
instrument problem. Refer to
Support Services.
Test Cancelled by Operator No response to mandatory No action required. Training may
prompt before analyzer time be required if a particular operator
out. has a high rate of cancelled tests.

Electrical or The following conditions are related to electronic or mechanical failures in

Mechanical Failures the analyzer.

Message on Display Cause Action

Analyzer Error The analyzer usually recovers from Push cartridge or Simulator straight
these errors when the Electronic through the cartridge port. This
Use Electronic Simulator Simulator is run. This error can error can also occur if the Electronic
occur if the cartridge or Electronic Simulator is malfunctioning (has
Simulator was “angled” when it been dropped?). Try another
inserted. Simulator. If the analyzer passes the
Electronic Simulator check, continue
to use it. If not, or if the Quality Check
Code is recurrent, the analyzer may
need repair.
Analyzer Error These are mechanical or electronic Use an external Electronic Simulator
failures from which the analyzer twice and use a cartridge with sample
See Manual
may not be able to recover. or control solution. If an error
condition occurs, refer to Support
Services.
If not, continue to use the analyzer.
Cartridge Type Not Recognized This error could be due to use If this is a new cartridge type being
of a cartridge type that is not used, update the software. If the
Use Another Cartridge
compatible with the version of cartridge type has been used before,
software in the analyzer. check to see if the cartridges have
expired. Otherwise, an analyzer
problem is indicated and the analyzer
may need repair.

Art: 714381-01C Rev. Date: 07/12/04 19-5

Glucose Strip Errors
Message on Display Cause Action

Strip Error The test strip or the test port is Remove the test strip.
Use Another Strip wet, defective, contaminated, Press 1 for Test Options.
or the wrong test strip was
Code 100 inserted. Press 1 for Same Patient or Level.
Repeat the test.
Strip Error The test strip was removed Press 1 for Test Options.
Use Another Strip from the test port during Press 1 for Same Patient or Level.
testing.
Code 101 Repeat the test.
Strip Error Test unsucessful. An error was Remove the test strip.
Use Another Strip detected during the analysis Press 1 for Test Options.
sequence.
Codes 103, 105, 106, 107 Press 1 for Same Patient or Level.
Repeat the test.
If the problem persists, record the
three digit error code and contact
Support Services.
Strip Error The test strip malfunctioned Remove used test strip.
Use Another Strip or the blood glucose level Press 1 for Test Options.
is beyond the measuring
Codes 102, 104 capability of the test strip and Press 1 for Same Patient or Level.
strip reader. Repeat the test with a new test
strip. If the error occurs again,
confirm the result by performing
the test by a different method.
Contact Support Services.
Temperature Out of Range During the test, room Ensure that the room temperature
Check Status Page temperature became unstable is within the secified limits. Allow
or moved outside the limits the analyzer to stabilize to room
Codes 108, 109 within which the test strip temperature: 15 to 40 °C or 59 to
reader can perform a test. 104 °F .
Press the Menu key until the
Administation Menu is displayed.
Press 1 for Analyzer Status where
the room temperture reading is
displayed.

19-6 Art: 714381-01C Rev. Date: 07/12/04

No Display
Symptom Possible Cause Action

The display screen remains Batteries dead. Keypad not Change or recharge batteries. If
blank, either after a cartridge responding. Internal Start this does not fix the problem,
has been properly inserted switch broken. reinstall the current software in the
or after the On/Off key has analyzer. If the problem persists,
been pressed. the analyzer should be returned
for repair.

“Cartridge Locked”
Not Removed Symptom Possible Cause Action

Normally the analyzer Dead batteries. Mechanical Wait until the analyzer turns off or
will reset and release the problem. turn the analyzer off. Then turn
cartridge after the testing the analyzer on. If it can reset,
cycle is completed. If the it will release the cartridge and
analyzer cannot reset, the remove the “Cartridge Locked”
“Cartridge Locked” message message. If the cartridge is not
will remain on the screen. released, change or recharge the
battery and turn the analyzer on.
If the “Cartridge Locked” message
does not disappear, do not attempt
to remove the cartridge and refer
to Support Services.

Art: 714381-01C Rev. Date: 07/12/04 19-7

 THEORY 20
ANALYZER FUNCTIONS

Introduction The i-STAT 1 analyzer is a microprocessor-controlled electromechanical

instrument designed to:

• identify the cartridge type.

• control the flow of fluids within the cartridges.
• mix sample and reagent (where applicable).
• apply electrical signals to certain types of sensors within the
cartridges.
• control the temperature of the cartridge at 37°C (where applicable).
• measure electrical signals generated by the sensors (cartridge and test
strip).
• measure the barometric pressure of the surrounding environment
(where applicable).
• calculate concentrations of analytes using the generated electrical
signals.
• display the results in numerical values and on bar graphs (where
applicable).
• communicate the results to a printer and computer.
• sense and communicate operational errors.
• maintain an internal clock/calendar.
• store all test records, Electronic Simulator results and Quality Check
Codes and messages.

Microprocessor The microprocessor control system manages all functions of the analyzer. It
System accesses three types of memory storage devices. A “FLASH” EEPROM module
stores the software program in the analyzer. The RAM, which is backed up
by an internal lithium battery, is used for temporary storage of sensor signals
measured during operation and for storage of test records. Another EEPROM
stores factory calibration information, the instrument serial number and
cumulative count of uses. Neither of the EEPROMs relies on the lithium
battery for maintaining information.

Sensor Interface Electrical signals from the cartridge sensors are conducted from the contact
pads on the cartridge, through the internal connector in the analyzer, to the
sensor interface circuit board. Electrical signals from the test strip sensor are
conducted from the contact bars to a sensor interface circuit board. These
circuits amplify the signals from the sensors so that they can be further
processed by the main electronic circuit board. Four signals are relayed to the
main electronic circuit board from the cartridge sensor interface circuit board:

Art: 714382-01B Rev. Date: 06/13/03 20-1

 • A multiplexed potentiometric signal line
• A multiplexed amperometric signal line
• An AC fluid conductivity signal
• A digital identification code to identify the type of cartridge being
inserted into the analyzer

Mechanical System A single DC gearmotor drives mechanical system components:

• An electrical interconnecting system which brings the analyzer’s

electrical internal connector into contact with the contact pads on
the cartridge
• A calibrant delivery system
• A sample delivery system
• A thermal control interconnectivity system which brings the
analyzer’s thermal controller into contact with heater elements on
the back of cartridges. In addition, a latching mechanism locks the
cartridge into place upon insertion.

Analog-to-Digital An analog-to-digital converter converts all analog signals into digital form so
Conversion that the microprocessor can perform mathematical calculations on the signals.
An analog signal multiplexer makes it possible for the microprocessor to
measure eight different types of analog signals:

• The potentiometric signals from the sensor interface circuit

• The amperometric signals from the cartridge and test strip sensor
interface circuits
• A DC conductivity signal
• The battery voltage
• A thermistor signal representing the internal temperature of the
analyzer
• A motor feedback signal used to control the speed of the mechanical
motion
• Cartridge temperature signals used to control the cartridge
temperature to 37°C
• A pressure transducer signal representing the barometric pressure of
the environment

Analog Control The analyzer creates and applies two types of signals to the sensors: a digital-to-
Signals analog converter generates a voltage which is applied to amperometric sensors,
and the AC conductivity circuit generates an AC excitation signal which is
applied to the conductivity sensors. The digital-to-analog converter also
provides voltages to the motor driver circuit.

Operator Interface The microprocessor control system coordinates the reading of information
input by the user, the writing of information onto the display, and the
communication of results. The microprocessor control system, also,
communicates with a clock/calendar circuit allowing the operator to set and
read the time and date. The clock/calendar circuit is backed up by a lithium
battery.

20-2 Art: 714382-01B Rev. Date: 06/13/03

ELECTROCHEMICAL MEASUREMENTS

Method Measurements are performed on undiluted specimens. Undiluted methods are

also called direct methods, while methods requiring dilution of the sample are
called indirect methods.

Indirect methods measure the total molar concentration of analyte per

unit volume of plasma. Direct methods measure the total molar activity of
analyte (apparent or free ion activity) per unit volume of plasma water. It is
understood that the direct method result is the clinically significant result for
electrolytes. When there is disagreement between the methods, such as when
the patient has abnormal total protein or lipid levels, it is due to interference
on the indirect method.

At normal levels of protein and lipids the systematic offset between methods
is often corrected for in commercial direct measuring instruments so that the
normal ranges for all instruments are in agreement. Sensor outputs have been
set so that normal ranges are in agreement with indirect reference methods at
normal levels of total protein and lipids.

Sensors The general term “sensor” is used to refer to the three types of electrodes
incorporated into the cartridges:

• Potentiometric
• Amperometric
• Conductometric

Sensors are thin film electrodes microfabricated onto silicon chips. Sensing
functionality is imparted to each electrode by a number of chemically sensitive
films coated over the active region of the electrodes.

Potentiometric Potentiometry is the measurement of the difference in potential that exists

Sensors between an indicator electrode and a reference electrode. Ion-selective
electrodes (ISE) are examples of potentiometric sensors. The indicator electrode
is designed to be sensitive to a particular ion in a solution. In cases where other
ions are sensed by the system, selectivity coefficients can be used to correct for
this interference. An enzyme can be added to an ISE to produce ions from
analytes of interest that are not themselves ions.

The Nernst Equation The Nernst equation relates the measured potential to the activity of the ion
being measured.

E = E° + RT/nF ln a

Where E is the potential, E° is a constant dependent on the electrode/sensor

system, R is the gas constant, T is the absolute temperature, F is Faraday’s
constant, (n) is the valance (positive or negative charge) for the ion being
measured, and (a) is the activity of that ion.

The Nernst equation can be rewritten as:

E = E° + S log a

Art: 714382-01B Rev. Date: 06/13/03 20-3

 Where S replaces the constant term which defines the slope of the sensor.
The slope is the change in millivolts per tenfold change in the activity of the
analyte. For a positively-charged monovalent ion, the theoretical slope would
be 59.1 mV at 25°C.

Activity Versus Ion-selective electrodes measure activity rather than concentration. Activity (a)
Concentration γγ): a = γc.
is related to concentration (c) through the activity coefficient (γ): γ

While ion activities, which reflect free rather than total ion concentrations,
are the physiologically relevant quantity, activity values are converted to
conventional concentration units so that values obtained by direct ISE
measurements can be compared to values obtained from methods that measure
total ion concentrations. The latter includes the indirect methods, which
have activity coefficients close to unity or one, and flame photometric, atomic
absorption and titration methods.

Amperometric In amperometric measurements, a potential is applied to the measuring

Sensors electrode while current generated by the resulting oxidation or reduction
reactions in the test system is measured. The current generated is directly
proportional to the concentration of the analyte. An enzyme can be added to a
layer on or near an amperometric sensor to produce electroactive species from
analytes of interest that cannot themselves be oxidized or reduced.

Conductometric In a conductometric measurement, an alternating current is applied between

Sensors two electrodes in contact with the test solution and the resulting voltage
difference is measured. The conductivity of the solution is proportional to
the magnitude of the voltage difference. In aqueous solutions, conductivity is
dependent upon the concentration of electrolytes; an increase in the electrolyte
concentration causes an increase in conductivity.

DETERMINATION OF TEST RESULTS

Determination Potentiometric and amperometric sensors are used for the determination of
of Analyte analyte concentration. For both sensors, the concentration of the analyte
Concentration can be calculated using:

1) the known value of the analyte concentration in the calibrant

solution,
2) the measured voltage (potentiometric) or current (amperometric)
signal generated by the analyte in the calibrant, and
3) the measured signal generated by the analyte in the test solution.

For potentiometric sensors, the analyte activity in the sample is calculated from
the Nernst equation according to:

Esample - Ecalibrant = S log (asample/acalibrant).

Complex solutions such as blood deviate slightly from Nernstian behavior due
to interfering ions and matrix effects that result in junction potentials. By
including selectivity coefficients in the Nernst equation (Nikolsky equation),
these effects can be minimized. By characterizing the reference electrode in
different solutions, effects of matrix on the reference junction potential can
also be minimized.
20-4 Art: 714382-01B Rev. Date: 06/13/03
 It is known that direct methods read up to 7% higher than indirect methods
in measuring the concentration of electrolytes. This is because there is an
excluded volume occupied by plasma protein and lipids that is not considered
in indirect measurements. Typically, however, the elevation of results is less
than the full 7% because some of the analyte is bound to protein and other
ions, and is not assayed by direct methods. For each analyte this discrepancy
is characterized, and the result of the direct measurement is adjusted so that
normal ranges are in agreement with indirect reference methods at normal
levels of total protein and lipids.

DETERMINATION OF CELL CONCENTRATION

Hematocrit In whole blood, plasma conducts electricity while the cellular constituents, red
and white blood cells and platelets, do not. For a sample of a given electrolyte
concentration, as the number of cells per unit volume of plasma increases, the
conductivity of the sample decreases. The total cell concentration in whole
blood can, therefore, be determined from:

1) the known electrolyte concentration of the calibrant,

2) the measured electrolyte concentration of the sample,
3) the measured conductivity of the calibrant and
4) the measured conductivity of the sample.

These measured quantities are determined using a combination of

potentiometric and conductometric sensors.

Direct measurement of hematocrit by the conductometric technique gives a

result related to the non-conducting excluded volume fraction of the sample
fluid. Red blood cell volume is the predominant component of the non-
conducting volume, but proteins, lipids, and white blood cells also contribute.
Elevated hematocrit readings are expected at abnormally elevated levels of
these components. Decreased hematocrit readings are expected at abnormally
low levels of protein, such as found in hemodiluted samples taken from
patients on cardiopulmonary bypass.

Osmotic imbalance causes a discrepancy between direct (conductometric,

spun) and indirect (Coulter) measurements because of variation in the mean
cell volume.

CPB Each time a cartridge containing a hematocrit sensor is used, the operator has
the option of selecting, in addition to the sample type, the CPB compensation
algorithm for samples with abnormally low protein levels. The CPB option
is specifically intended for use when samples are collected from patients on
cardiopulmonary bypass. However, the facility may validate its use for other
patient populations known to have protein levels significantly lower than the
normal adult population.

The CPB algorithm infers the total protein level by assuming the pump priming
solution dilutes the hematocrit and total protein equally. Modeling the pre-
pump hematocrit as 43 %PCV and the pre-pump total protein as 7.0 g/dL, the
following graph indicates the inferred total protein and resultant correction.

Art: 714382-01B Rev. Date: 06/13/03 20-5

 For example:

• uncompensated Hct = 21 %PCV

• 21 %PCV = 0.50 of 42 %
• inferred total protein = 7.0g/dL x 0.50 = 3.5 g/dL
• 21 %PCV + 3 g/dL = 24 %PCV (CPB)

Limitations of the The CPB algorithm is based upon a series of inferences:

CPB Algorithm
• The algorithm models initial pre-pump values for total protein
and hematocrit. Although actual initial values may be different
than those used in the algorithm, typical deviations rarely affect
the accuracy of the correction by more than 0.5 %PCV. More often
than not, the actual values are consistent with a “pre-dilution” of the
modeled values.
• The algorithm assumes that the pump priming solution has no added
albumin or other colloid. The algorithm will tend to overcorrect if
solutions with added colloids are utilized, though the size of the over-
correction will seldom be more than 1 %PCV.
• Other therapies which affect the ratio of total colloids to hemaotcrit
(administration of colloids, packed red blood cells, etc.) will affect the
interference.

When to discontinue use of the CPB algorithm will depend on when the
patient's total protein level reaches the pre-pump level.

It is recommended that each practice verify the hematocrit determination for

cardiopulmonary bypass procedures so that the impact of these limitations
upon a particular practice’s protocol is understood.

20-6 Art: 714382-01B Rev. Date: 06/13/03

DETERMINATION OF COAGULATION ENDPOINTS

ACT and PT/INR In coagulation tests, the result that is reported is the time required for the
process of coagulation to occur. To determine this time, there must be a
detectable change in a sample parameter correlated to progression of the
process. In traditional coagulation tests, endpoint detection typically relies
on monitoring increases in either blood viscosity or plasma turbidity that
occurs as thrombin converts fibrinogen to clotable fibrin. In an electrogenic
test an electroactive marker that can be detected at either an amperometric or
potentiometric sensor is used to indicate the endpoint. The marker is generated
when a substrate that has been added to the test sample is acted upon by
thrombin. As the coagulation reaction proceeds, the marker concentration
increases, increasing the signal at the sensing electrode. The time required
for generation of the marker correlates to the time required for conversion
of fibrinogen. The coagulation endpoint can, therefore, be determined by
monitoring the marker concentration. Unlike traditional coagulation tests,
electrogenic tests will not be prolonged in samples with abnormally low (less
than 100 mg/dL) fibrinogen levels.

QUALITY CONTROL AND THE I-STAT SYSTEM

Overview Quality control, as a component of an overall quality assurance program,
consists of tests and procedures for monitoring and evaluating the analytical
performance of a measurement system to assure the reliability of patient test
results.

As new technologies evolve, quality control regimens must match the

requirements of the particular analytical system. i-STAT Corporation
recognizes the importance of effective quality control for its analytical
medical devices, and has developed a program that is tailored to the unique
characteristics of the i-STAT System.

The i-STAT System performs blood analysis when a unit-use cartridge filled
with a patient’s sample is inserted into a handheld analyzer or Blood Analysis
Module (as part of the Agilent Viridia Patient Monitoring System).

The measurement methodologies are electrochemical, using microfabricated

sensors housed in each cartridge to measure analyte concentrations directly in
a single whole blood sample (i.e., neither dilution nor reagent mixing steps are
required).

Two characteristics of the i-STAT System, which distinguish it from traditional

laboratory equipment, have significant impact upon the design of the quality
control regimen: its intended user and the unit-use cartridge technology.

As the system is intended to be used by individuals not trained in laboratory

science, the onus is upon the system’s design to ensure that the quality of
results is not dependent upon either user technique, skilled maintenance and
calibration procedures, or the accompanying quality control regimens which
ensure these procedures have been properly performed.

The use of unit-use cartridges frees the i-STAT System from these skilled
maintenance and calibration procedures. It also allows for the design of a
quality control system which automatically monitors those aspects of the
Art: 714382-01B Rev. Date: 06/13/03 20-7
 measurement process which are the most likely to impact quality, including the
characteristics of the individual sensors and the operator’s actions.

i-STAT’s quality control regimen has four aspects, resting on the foundation
of a system design which reduces the opportunity for the type of error which
traditional quality control regimens are designed to detect:

1) A series of automated, on-line quality measurements that monitor the

sensors, fluidics and instrumentation each time a test is performed.
2) A series of automated, on-line procedural checks monitors the user
each time a test is performed.
3) Liquid materials are used to verify the performance of a batch of
cartridges when they are first received or when storage conditions are
in question.
4) Traditional quality control measurements verify the instrumentation
using an independent device, which simulates the characteristics of
the electrochemical sensors in a way which stresses the performance
characteristics of the instrumentation.

Similarities Although the more significant aspects of i-STAT’s quality control regimen are
to Traditional the quality checks automatically performed with each unit-use cartridge, many
Laboratory Quality principles of the quality control regimen are similar to traditional regimens.
Control Regimen
Laboratory quality control methods are statistical. They assess the quality of
the measurement process by intermittently inserting pseudosamples (controls)
into the stream of samples being tested.

The approach implicitly assumes that the elements of the measuring

system persist from run to run so that the repeatability and accuracy of the
measurement of patient samples can be predicted by the repeatability and
accuracy of pseudosamples.

The i-STAT regimen uses an analogous approach to monitor the part of the
testing process which persists from run to run – the handheld analyzer or Blood
Analysis Module.

An Electronic Simulator, which mimics the electrical characteristics of the

signals produced by the sensors, is inserted into the handheld analyzer or Blood
Analysis Module on a daily basis. The Simulator produces signals consistent
with both very low and very high concentrations of each of the analytes. The
analyzer or module causes the Simulator to change the signals via a control
signal fed through the interconnect.

The software in the analyzer and module measures these signals as it would
measure signals from a cartridge. The software checks the measurements
against predetermined thresholds and indicates their acceptability to the user
via a PASS/FAIL message.

An important aspect of the Simulator is that it mimics the sensitive nature of

the sensor’s signals to ensure that adjacent input channels within the analyzer
or module maintain the required degree of electrical isolation from each other
to prevent “crosstalk” (see US Patent #5124661 for details). This cannot be
achieved by the traditional internal self-consistency checks characteristic of
modern microprocessor-controlled instrumentation.

20-8 Art: 714382-01B Rev. Date: 06/13/03

 Comparison of this regimen to laboratory quality control procedures can seem
confusing because it does not employ liquid control solutions. However,
the principle is the same in that the traditional intermittent quality control
measurements are applied to the persistent part of the system. In the case of
the i-STAT System, only the instrumentation is persistent so only this portion is
tested with an external challenge.

Further, use of an electronic quality control device has distinct quality

advantages:

1) Non laboratory-trained individuals do not need to interpret control

results because the analyzer and module software, expecting certain
simulator signals, automates the interpretation. In comparison,
many quality control regimens using liquid controls at the point of
care are ineffective because an out-of-control result is easy to ignore.
2) Injecting signals into the analyzer or module allows very tight
control limits to be set. Control limits using liquid controls at the
point of care are generally very wide to allow for sensor-to-sensor
variation.

The i-STAT Unit- The most important quality measure in the i-STAT System is that it is designed
Use Cartridge as an to reliably deliver quality results in the hands of individuals not trained in
Element of Design laboratory science. It addresses those aspects of the design in traditional
Robustness for Point- laboratory-based equipment and other point-of-care devices which detract from
of-Care Testing robustness in the hands of these individuals.

1) In the interest of making batch processing efficient, laboratory

devices make extensive use of components which are exposed to
each test sample (sensors, tubing, etc.). These devices must be
continuously recalibrated as successive samples interact with these
elements. Quality control regimens are designed to detect incorrect
or required calibrations.
All elements which are exposed to the test sample are unit-use in
the i-STAT System. Many of the out-of-control conditions which a
laboratory quality control regimen is designed to catch simply do not
exist.
Furthermore, the use of unit-use devices is directly related to the
design of i-STAT’s quality approach. Each test begins with fresh
sensors and a fresh calibrant fluid. The response of the sensors’
signals to the fresh calibrant fluid is well characterized from a large
database of tests run in i-STAT’s manufacturing facility. If the sensor
signal is uncharacteristic due to mismanufacture, mishandling
or misstorage, the handheld analyzer or Blood Analysis Module’s
software will suppress the result (displays “***”).
2) Many point-of-care devices require the non laboratory-trained
user to interact directly with the sensing elements (paper strip
technologies for example). Many Point-of-Care Coordinators rely
heavily on the daily quality control regimen not only as a means for
monitoring system performance, but more significantly, as a means
for monitoring user proficiency.
The analyzer controls all fluid motions in the i-STAT System. The
calibrant and sample are brought to the sensors under instrument
control so that the user does not directly impact on the quality of the
analytical process and therefore cannot impinge on the quality of the
results.
Further, the analyzer uses a fluid sensor to electronically verify the
proper flow of fluids within the cartridge on every run. This can
easily be demonstrated by attempting to fool the system by:

Art: 714382-01B Rev. Date: 06/13/03 20-9

 •putting in too much sample
•putting in too little sample
•rerunning the same cartridge
•introducing an air segment into the fluid segment, etc. The
analyzer will flag these conditions and not deliver a result.
3) The design of some unit-use point-of-care devices can allow an
entire batch of unit-use devices to be affected by a single event, for
example, by leaving a tube of paper strips open and exposed to a
high humidity environment.
With the i-STAT System, each unitized device is sealed in a separate
foil pouch and has its own individual history. The only external
factor, which can create a shared history among cartridges, is
temperature. This is controlled by appropriately monitoring the
storage environment.

The Foundation of The fundamental backbone of i-STAT’s quality regimen is the series of automatic
i-STAT’s Quality checks performed each time a cartridge is run.
Control Regimen
– On-Line Tests The tables below list the key elements and operations of the i-STAT System that
are verified each time a cartridge is used.

For completeness, those operations which are qualified by the Electronic

Simulator are also listed.

Unit-Use Cartridge
Verification When Verified
Microfabricated Electrochemical Sensor Elements
• verify sensors are present Every cartridge use
• verify sensor characteristics are consistent with Every cartridge use
expectations of a properly manufactured and maintained
device (by testing calibration fluid)
Calibration Fluid
• verify fluid is present Every cartridge use
• verify fluid is delivered free of bubbles Every cartridge use
• verify fluid has proper concentration Every cartridge use
Fluidic System
• verify sample holding chamber is sealed Every cartridge use
• verify fluid flowpaths are intact (no part of the analyzer or Every cartridge use
module comes into direct contact with fluid)
• verify waste chamber is not occluded Every cartridge use
Elements that interact with the handheld analyzer or Blood
Analysis Module
• verify electrical contact pads (that allow access to sensor Every cartridge use
signals) are unoccluded
• verify internal element of cartridge that allows the Every cartridge use
analyzer or module to control the release of calibration
fluid over the sensors is functioning properly
• verify internal element of cartridge that allows the Every cartridge use
analyzer or module to control the replacement of
calibration fluid with sample is functioning properly

20-10 Art: 714382-01B Rev. Date: 06/13/03

Handheld Analyzer
and Blood Analysis Verification When Verified
Module Motorized Mechanical System
• verify electrical contact is made with sensors on cartridge Every cartridge use
• verify ability to properly move calibration fluid Every cartridge use
• verify ability to properly move sample Every cartridge use
Electrical Measurement System
• verify voltage measuring system for potentiometric Every cartridge use
sensors
• verify current measuring system for amperometric Every cartridge use
sensors
• verify resistance measuring system for conductometric Every cartridge use
sensors
Other
• verify internal self-consistency of electronic systems Every cartridge use
• verify fluid flow using the conductivity sensor Every cartridge use
• verify function of transducers used for measuring Every cartridge use
barometric pressure
• verify function of the thermistors used to control chip Every cartridge use
temperature

Operator Sample
Handling/Cartridge Verification When Verified
Verify the cartridge inserted has not been previously used Every cartridge use

Verify the calibrant pack has not prematurely ruptured Every cartridge use
Verify the electronic contact pads are dry and Every cartridge use
uncontaminated
Verify the proper amount of sample was placed into the Every cartridge use
sample chamber
Verify the sample was properly positioned within the sample Every cartridge use
chamber
Verify the sample is free of included bubbles Every cartridge use
Verify the sample is not clotted Every cartridge use
Verify the sample chamber is properly sealed with the snap Every cartridge use
closure

Art: 714382-01B Rev. Date: 06/13/03 20-11

Validating the Until recently, regulations and laboratory accreditation standards specified the
Performance of the use of traditional quality control regimens, including the daily use of liquid
i-STAT System “control” materials.

As new technologies such as the i-STAT System have become available, the
community has recognized the limitations of relying upon traditional regimens,
prompting various regulatory and accreditation organizations to modify their
standards accordingly.

Many of the newly drafted regulations and accreditation standards recognize

the danger of denoting specific methods of achieving an effective quality
control regimen. Additionally, specific methods cannot anticipate future
technological changes, so many of the regulatory and accreditation
organizations are changing their standards to place the responsibility of
establishing and validating the quality system a laboratory employs on the
laboratory director.

Quality control regimens should be established using information from the

manufacturer and scientific literature.

It is important to validate the performance of the i-STAT System and the

recommended quality control regimen to develop personal confidence in
our approach to the challenges of putting a diagnostic device in the hands of
individuals untrained in laboratory science.

Some of the regulatory and accreditation organizations recommend the daily

use of liquid “control” materials for the first month of use, slowly stepping back
the frequency as a database of performance information increases confidence
levels. The number of lots of materials examined should also be considered
when determining a validation protocol.

QUALITY CONTROL AND THE i-STAT COAGULATION TESTS

Operating Principles The i-STAT coagulation cartridges measure the time required for complete
of the Coagulation activation of the coagulation cascade once initiated by the activator.
Cartridge–Overview Coagulation instruments determine this time by sensing a characteristic change
in a measured property of the sample. In the i-STAT System the measured
property is the concentration of an electroactive marker . The time to clot
is indicated by a relative increase in the concentration as measured by an
amperometric sensor.

i-STAT dries the activator and a precursor of the electrochemical marker (a

substrate to the thrombin enzyme produced by the coagulation cascade) onto
the wall of the reaction chamber during the manufacturing process. At the
beginning of the test the system agitates the blood back and forth across the
chamber wall to mix these reagents into the blood sample.

Quality System The critical performance feature of the coagulation cartridge centers on the
for Coagulation repeatability of the reagent mixing process. The accuracy to which the reagent
Cartridge is mixed into the blood sample directly impacts the accuracy of the result.

20-12 Art: 714382-01B Rev. Date: 06/13/03

 The system quantitatively confirms the accuracy of the mixing step by
monitoring the key parameters of mix uniformity, magnitude and timing.
These quality tests are performed on each coagulation cartridge.

i-STAT’s microfabrication production processes are inherently ca pa ble of

creating sensors with highly reproducible characteristics. For the measurement
of blood gases, electrolytes and chemistries, this means that the i-STAT System
requires only a one-point calibration, using a calibrant solution packaged in
the cartridge, to meet the demanding requirements for clinical accuracy. As
described in the Quality Control section of the i-STAT System Manual, the
calibrant solution is also used to verify the integrity of the sensors as a key
component of the quality system.

For the measurement of ACT and PT, the required accuracy for the
amperometric sensor to detect the relative increase in concentration of
the electroactive marker is more modest. A calibrant solution is required
neither for a one-point calibration nor to verify the wetup characteristics of
the sensor. Instead, the magnitude and rate of change of current is assessed
quantitatively throughout the test in order to verify the quality of the mix,
and the integirity of both the sensor and the reagent coating.

Regulatory Aspects Alternatives to traditional quality systems have been developed that are suitable
of the Quality System for ensuring the performance of unit-use in-vitro diagnostic systems. These
for Coagulation alternative systems rely upon a variety of internal self-tests and electronic/
optical checks. As unit-use devices have become more widespread in clinical
practice, regulations and guidance documents have adapted to recognize the
effectiveness of these alternative quality systems, albeit with some variation.
For example, some state regulations require that the alternative quality
system include an on-board “wet” control. The i-STAT Quality System for
the coagulation test is able to address this requirement even though the
cartridge does not contain an on-board wet calibration fluid. The quantitative
confirmation that the activator and the marker are accurately mixed into the
blood sample is a “wet” test that acts as a control of the most critical aspect of
the coagulation test.

Electronic Quality i-STAT’s electronic simulator (both the internal and external versions) check
Control the amperometric and conductivity circuitry used in the coagulation tests at
multiple levels. The instrument checks the accuracy of the measurement of
elapsed time each time a test is run by comparing the clock rates from two
independent clocking circuits. The instrument also runs a battery of general
instrument checks during each test.

Art: 714382-01B Rev. Date: 06/13/03 20-13

 DOWNLOADER PROGRAMMING AND WIRING 21

PROGRAMMING THE NETWORK DOWNLOADERS

This section includes procedures to configure the network Downloaders to

transmit data between the i-STAT 1 Analyzers and the Central Data Station (CDS)
program as well as from other peripheral devices to the CDS or other PC.

Preparation 1. Determine for each Downloader: IP Address, Gateway Address, and Subnet
Mask.
2. Determine for the Workstation: The IP Address of the Point-of-Care Central
Workstation and the Central Data Station service port for i-STAT 1 Analyzer
transmissions (typically 6004).

Configure a Terminal 1. Run a terminal emulation program, such as HyperTerminal, and choose the
Session following port settings:
Bits per second: 9600
Data bits: 8
Parity: None
Stop Bits: 1
Flow Control: None

Connect to and 1. Connect one end of a Null-Modem Cable to the DB9 Port on the
Program the Downloader and connect the other end to the COM port selected in the
Downloader session above to the Point-of-Care Central Workstation as shown below.
Do not apply power to the Downloader at this time.
 Power In
‚ DB9

Art: 714383-01C Rev. Date: 12/15/03 21-1

 2. While holding down the x key on the PC keyboard, apply power to the
Downloader. When the following screen is displayed release the x key:

3. Press the Enter key immediately to enter the Setup Mode:

Configure Server Each network Downloader requires a unique IP Address, the Gateway Address,
Parameters and, if required, a Subnet Mask. The following describes how to configure the
network Downloader’s server parameters.
1. Determine the following site specific information for this Downloader:
• IP Address (Example: 10.10.12.142 used below)
• Gateway Address (Example: 10.10.12.1 used below)
• Netmask (Example: 8 for 255.255.255.0 used below)

21-2 Art: 714383-01C Rev. Date: 12/15/03

 2. At the Your choice? prompt, Select 0 for Server Configuration and enter
the information chosen for this Downloader.
3. At each of the prompts enter the bold-faced value.
Note: If the information to be entered is the same as the default
value, press the Enter key.
• IP Address: (000)10.(000) 10.(000)12.(000)142
• Set Gateway IP Address: (N) Y
• Gateway IP addr: (000)10.(000)10.(000)12.(000) 1
• Netmask: Number of Bits for Host Part (00) 8
Note: The Netmask is configured as the number of host bits
required based on the subnet being used.

• Change telnet config password: (N) N

Default Netmasks
for Standard IP SUBNET MASK HOST BITS NETWORK TYPE
Networks
255.0.0.0 24 Class A

255.255.0.0 16 Class B

255.255.255.0 8 Class C

Netmasks for Other

Networks SUBNET MASK HOST BITS SUBNET MASK HOST BITS

255.255.255.252 2 255.255.192.0 14

255.255.255.248 3 255.255.128.0 15

255.255.255.240 4 255.255.0.0 16

255.255.255.224 5 255.254.0.0 17

255.255.255.192 6 255.252.0.0 18

255.255.255.128 7 255.248.0.0 19

255.255.255.0 8 255.240.0.0 20

255.255.254.0 9 255.224.0.0 21

255.255.252.0 10 255.192.0.0 22

255.255.248.0 11 255.128.0.0 23

255.255.240.0 12 255.0.0.0 24

255.255.224.0 13

Art: 714383-01C Rev. Date: 12/15/03 21-3

Configure Channel 2 Channel 2 provides network access for the i-STAT 1 Analyzer data transmissions
to the i-STAT Central Data Station running on the Data Manager. This section
describes how to set up parameters for Channel 2.

1. Determine the following information:

• The IP address of the Data Manager. (Example: 10.10.12.184)
• The service port number set to receive transmissions from the
i-STAT 1 Analyzer (typically 6004).
2. At the Your choice ? prompt, Select 2 (Channel 2 Configuration).
3. At each of the prompts enter the following bold-faced value:

Note: If the information to be entered is the same as the default

value, press the Enter key.
• Baudrate (38400) ? 38400 (must be set to 38400)
• I/F Mode (4C) ? ((press <Enter> key)
• Flow (00) ? ((press <Enter> key)
• Port No (10002) ? ((press <Enter> key)
• ConnectMode (C1) ? C1 (must be set to C1)
• Remote IP Address : (000)10.(000)10.(000)12.(000) 184
Note: Set Remote IP Address to the IP Address of the Point-of-
Care Central Workstation.
• Remote Port (06004) ? 6004
Note: Remote Port refers to i-STAT 1 service port defined in
the Central Data Station program.
• DisConnMode (00) ? ((press <Enter> key)
• FlushMode (44) ? 44 (must be set to “44”)
• DisConnTime (00:30) ? 00:30 ((Disconnect time must be 30
seconds)
• SendChar 1 (00) ? ((press <Enter> key)
• SendChar 2 (00) ? ((press <Enter> key)

Verify and Save 1. When the Summary screen appears, verify that the information you
Settings entered is correct. If it is not, fix the appropriate settings and continue.

21-4 Art: 714383-01C Rev. Date: 12/15/03

 2. Save the settings by selecting 9 (Save and Exit) at the Your choice ?
prompt.
3. Remove power and connect the Downloader in its intended location.

Troubleshooting If a wrong number is entered, which cannot be corrected, press the Enter key
until the session is completed and start from the beginning again.

Art: 714383-01C Rev. Date: 12/15/03 21-5

WIRING THE DOWNLOADERS
Overview This section includes diagrams to make a connection between the Downloaders
and the Data Manager and to connect a printer to the Downloaders.

Caution Non i-STAT devices may not be connected to the Downloader and Downloader/
Recharger. Only the Martel printer may be connected to the Downloader using
cables supplied by i-STAT.

Connecting Option 1: The following diagram shows how to connect the portable printer
the Network to the network Downloader for communication. Parts required are:
Downloader
• Printer Interface Cable
• Printer Power Adaptor
 Power In
‚ Power Out
ƒ RJ12 (printer interface)
„ DB9
RJ45 (network)

21-6 Art: 714383-01C Rev. Date: 12/15/03

 Option 2: The following diagram shows how to connect the portable printer
to the network Downloader for power and communication. Parts
required are:
• Printer Interface Cable
• Printer AC Adapter or Printer Power Cable
 Power In
‚ Power Out
ƒ RJ12 (printer interface)
„ DB9
RJ45 (network)

Art: 714383-01C Rev. Date: 12/15/03 21-7

Connecting the Serial Option 1: The following option is for downloading/uploading only and
Port Downloader can be used when there is no power outlet available for the
Downloader or Downloader/Recharger.
In this particular configuration, both recharging LED lights will be
lit. The primary recharging LED will blink red and the alternate
will be steady green. This is typical behavior, and does not indicate
that any charging is taking place. In fact, batteries cannot be
charged in the Downloader/Recharger in this configuration.
The following diagram shows how to connect a serial downloader
locally to the Data Manager. Parts required are:
• PC/Downloader Adapter
• DB9-DB9 Null Modem Cable
 Power In
‚ Power Out
ƒ RJ12 (printer interface)
„ DB9

21-8 Art: 714383-01C Rev. Date: 12/15/03

 Option 2: The following diagram shows how to connect a serial downloader
to the Data Manager, and to connect the portable printer to the
Downloader for communication. Parts required are:
• DB9-DB9 Null Modem Cable
• Printer Interface Cable
• Printer AC Adapter
 Power In
‚ Power Out
ƒ RJ12 (printer interface)
„ DB9

Art: 714383-01C Rev. Date: 12/15/03 21-9

 Option 3: The following diagram shows how to connect a serial downloader
to the Data Manager, and to connect the portable printer to the
Downloader for power and communication. The printer can also
be powered by its own AC adpator. Parts required are:
• DB9-DB9 Null Modem Cable
• Printer Interface Cable
• Printer Power Cable or Printer AC Adapter
 Power In
‚ Power Out
ƒ RJ12 (printer interface)
„ DB9

21-10 Art: 714383-01C Rev. Date: 12/15/03

 CENTRAL DATA STATION 5 22
i-STAT LICENSE AGREEMENT AND WARRANTY FOR CENTRAL DATA STATION PROGRAM

EULA For new users of CDS software the license and warranty information in the End
User License Agreement (EULA) will be in effect.

License The i-STAT Central Data Station software is licensed to the authorized user
by i-STAT Corporation. Portions of the software are licensed to you by i-STAT
Corporation under sublicense from other original software providers. By
accepting and using this software, the user/licensee agrees to the following:
• The user/licensee will not make copies of the software programs or any
of the program software files generated by the programs, the manual
or other documentation except for archive copies made as part of user/
licensee’s regular back-up procedures.
• The user/licensee will protect the programs from unauthorized use,
illegal reproduction (including reproducing any of the software files
generated by the programs) or illicit distribution.
• The user/licensee will not change or reverse engineer the programs or
any of their software files by debugging, decompiling, disassembling,
reprogramming, rewriting the programs’ macros, revising the programs’
forms or any other means.
If the user/licensee makes any use, transfer or disclosure of the programs in
violation of any of the foregoing, the sub-license will, at the option of i-STAT,
immediately terminate without demand or notice and the user/licensee will
immediately give to i-STAT the programs, the manuals and all copies thereof
in the user/licensee’s possession.

Warranty i-STAT warrants the licensed software and accompanying physical

documentation to be free of defects for a period of thirty days from the date
of installation. If notified of defects within the warranty period, i-STAT will
replace the defective software or documentation as soon as practical for the
nature of the defect. The remedy for breach of this warranty is limited to
replacement and shall not encompass any other damages including but not
limited to loss of profit, and special, incidental, consequential or other similar
claims. i-STAT specifically disclaims all other warranties, expressed or implied,
including but not limited to implied warranties of merchantability and
fitness for a particular purpose, with respect to the software, accompanying
documentation and the license granted herein.

Rev. Date: 07/12/04 Art: 714384-01C 22-1

22-2 Art: 714384-01C Rev. Date: 07/12/04
INSTALLATION OF THE CENTRAL DATA STATION

Hardware The PC on which the CDS software resides must meet specifications provided
by i-STAT Corporation and should be installed following the PC manufacturer’s
directions. Install the printer if applicable.

Software Installation: A license key is required to install the Central Data Station software. The
License Key license key ensures that the end user agrees to the License Agreement which is
displayed during installation. To obtain the license key, follow the instructions
on the screen and listed below.
1. Insert the CDS CD and the installation will begin automatically.
2. Click Next> in the Welcome dialog.
3. The End-User License Agreement will be displayed. Read the agreement
and if you agree to abide by the agreement, click Yes to proceed
with the installation. If you do not agree, click No to abandon the
installation.
4. Record the serial number of the CDS displayed in the Enter License Key
dialog.
5. Go to the i-STAT web site at http://www.i-stat.com and click on the
link under CDS Key Generator in the right hand column. You can also
access this link directly at http://www.i-stat.com/cdslicense. (In the
USA, the license key can also be obtained from Technical Support.)
6. If you are already registered, skip to step 8. If you are not registered, fill
out the required information, select Basic Access, and click Register.
7. Go back to the i-STAT web site as directed in step 5.
8. Enter your username and password and click Login.
9. You may now enter the serial number recorded in step 4, and click
Submit.
10. If successful, a message will appear indicating that your key has been
e-mailed to the address with which you registered.
11. Obtain the key from the e-mail and enter it in the space provided on
the CDS.
12. Click Next to proceed with the installation.

Caution The use of other software that was not provided as part of the system on the
same PC with the Central Data Station software may compromise the system,
including permanent loss of patient records.

Site Specific During installation, the CDS must be customized to properly communicate
Customization with i-STAT 1 Downloaders and Downloader/Rechargers, i-STAT IR Links and
of the CDS Philips Medical Systems Blood Analysis Modules throughout the hospital. The
procedure to customize the CDS is described under the Customization section
below.
The date displayed with results can be changed to any Short Date format and
separator listed in the computer’s Control Panel under Regional Options (or
something similar, depending on the version of Microsoft Windows in use). If
an unsupported format or separator is detected, the user will be notified and
given the opportunity to change to a supported format/separator combination.

Rev. Date: 07/12/04 Art: 714384-01C 22-3

 Connectivity Basic information needed to connect the Downloaders, Downloader/
Rechargers, and the portable printer to the PC are in the Downloader Wiring
and Programming section of this manual.
For assistance in programming the Downloader, Downloader/Recharger and IR
Links, contact your i-STAT support representative.

Interface Basic information on interfacing can be found in the "Interface" paragraph

under "Customization of the Central Data Station" in this section of this
manual and in section 8.

22-4 Art: 714384-01C Rev. Date: 07/12/04

GENERAL PROCEDURES AND CONVENTIONS

Overview The CDS software follows typical Microsoft® Windows® conventions and
procedures. The illustrations below are used to point out the use of the menu
bar, toolbars, tabs and buttons.

Selecting Menu Clicking an item on the menu bar (1) will drop down the menu for that item.
Options If any of the items in the drop down menu has a submenu, the submenu
will open to the right of the symbol next to the item when the item is
highlighted (2).

Clicking the  beside a toolbar button (3) will drop down a submenu toolbar
(4).

Clicking the desired menu option will open the item’s window or will perform
the item’s function. The menu items and toolbar for the active window will be
displayed (5).

10

Rev. Date: 07/12/04 Art: 714384-01C 22-5

 Selecting Functions in Tabs: A window may have several functional groupings that are contained
a Window in tabs (6) with multiple pages. Clicking the text on the tab will display the
corresponding page.
Buttons: Use to activate a function within a window (7) or to confirm (OK)
or cancel a function or to manipulate a window. All windows can have the
following buttons in the upper right hand corner (8):

This button causes the window to be maximized.

This button causes the window to be minimized.

This button causes the window to be moveable and resizable.

This button causes the window to close.

If a window does not have a close button, it can be closed by selecting Main
then Close on the menu bar.
Check boxes: Click the box to enable or disable a single option (9).
Radio buttons: Click the circle to select from a list of mutually exclusive
options.
Highlight bar: Use to select the line or lines on which to apply a function
(10).
Drop down list: Click the  button to drop down a list or scroll downward in
a window.

Refreshing/Updating
the Data in a The Refresh toolbar button refreshes the data content in the active window
Window with the most recent data available. The refresh function is also available under
the Window option on the menu bar. Pressing F5 will also refresh the data.

22-6 Art: 714384-01C Rev. Date: 07/12/04

Sorting Data In most cases, when data is presented in a table, clicking a column header
in a Window will sort the display based on the data in that column. In the Data Viewers,
repeating values, such as a patient ID, will be sorted in descending Date/Time
order. Clicking the header again will reverse the order of the sort. To return the
data to chronological order, click the Date-Time column header.

Selecting In many functions, multiple lines can be selected for the desired action.
Multiple Lines To select consecutive multiple lines, click the first line and, while holding
down the Shift key, click the last line. To select multiple lines that are not
consecutive, click the desired lines while holding down the Ctrl key.

Opening Multiple Multiple windows can be open at the same time. The Windows item on the
Windows menu bar can be used to select the desired window from the list of open
windows and bring it to the forefront. Close windows by clicking the Close
button at the top right of the window or by selecting Close from the Main
menu.

Column Ordering Columns in the Data Viewers can be placed in any order. Use the mouse to
grab a column header and drag the column to the desired position.

Column Widths To adjust a column’s width in Data Viewers, place the mouse pointer on the
edge of the column header. When the mouse pointer turns into two arrows,
hold the left mouse key and drag column to the desired width.

Toolbars Select Tools ➩ Customize Toolbars... to select options for the way toolbars
appear. Checking Large Buttons displays descriptive text under toolbar
Helpful Hint! buttons. This may be helpful while learning the application. Checking Show
Tooltips displays a description of a button when the mouse pointer is placed
over a toolbar button.

Rev. Date: 07/12/04 Art: 714384-01C 22-7

22-8 Art: 714384-01C Rev. Date: 07/12/04
CUSTOMIZATION OF THE CENTRAL DATA STATION
Overview The Customization options are:
Site Information Institution name and technical support phone number
Serial Ports Enables/Disables serial communications and allows
individual ports to be selected and configured
Network Enables/Disables network communications and allows
specification of TCP port numbers
Interface Enables/Disables external interfacing and allows protocol
to be selected
Options Allows various general system behaviors to be specified

Security Enables/Disables the CDS Security features which allow

for the creation of security profiles providing different
levels of access to various areas and functions of the CDS
application.

To access the Customization screen, close the CDS application, access the
Run dialog box by clicking Start ➩ Run.... Type wcds32 config at the Open:
prompt, then click OK.
If Run... is not on the Start menu, double click the Command
Prompt shortcut. At the C:\> prompt in the window that opens, type
c:\istat32\bin\wcds32.exe config and press Enter.
When the Customization screen appears, click a tab to display the desired
tab page. The information in each field can be specified. When all tabs are
customized as desired, click the Accept button to save the information. Click
the Reset button to disregard changes and restore the previous information.
Click the Cancel button to ignore any changes and retain the current settings.
When customization is complete, the CDS application will open automatically.

Site Information A site name and address of up to 60 characters can be entered into this field.
The appropriate Technical Support Phone Number for the country will be listed
or can be entered.

Rev. Date: 07/12/04 Art: 714384-01C 22-9

 Serial Ports The Central Data Station program resides on a PC with multiple serial ports
(DB9). Available ports will automatically be listed under Available Ports on
the Serial Ports tab page. The following components can be connected to the
Central Data Station via serial ports:
❑ i-STAT Series 200 Analyzer: IR Link transmits data to and from the
i-STAT Portable Clinical Analyzer.
❑ i-STAT Series 300 Analyzer: Downloader or Downloader/Recharger
transmits data to and from the i-STAT 1 Analyzer.
❑ Philips Module: a local connection to the CDS is needed to transmit
software updates and customization profiles to the Blood Analysis
Module.
❑ Philips CDS: The CDS server transmits patient data from the Blood
Analysis Module to the Data Manager.
Click the Enable serial communications box to check it and enable serial
communications.
Click the desired port(s) under Available Ports and click the <<<<Add button.
The port(s) will now be listed under Configured Ports.

Click the port and select an instrument for that port.

Serial ports on the PC might also be needed for a local PCx Docking Station and
connection to an interface.

Network Click the Enable network communications box to check it and enable
network communications.
The default TCP service port assignments are listed in the Network tab page. If
not using the default ports, click the port and type in the new assignment. Port
numbers must be unique and in the range of 1024 to 65535.
Note: If a PCx Docking Station is sharing the ethernet port with an i-STAT
Downloader, the PCx port assignment is made in QC Manager.

22-10 Art: 714384-01C Rev. Date: 07/12/04

Interface The appropriate interface protocol and the types of records to be sent to
another data management system are selected in the Interface tab page. This
configuration will typically be done by the interface provider.
Select the desired primary interface protocol. Then select the result types to be
sent to the interface.

❑ NONE: Indicates no primary protocol in use. Select when no

external interface is used and PCx glucose test strip data is to
be uploaded to QC Manager 2.2.

❑ AME: Automatic Manual Entry – installed by i-STAT Corporation.

❑ ASTM: Data transmission conforms to ASTM E1381-95 and ASTM

E1394-97 standards.

❑ Custom: Not supported at this time.

❑ Data File: Formats the CDS data for third party use.

❑ HL7: Data transmission conforms to HL7 (version 2.4) and

is based on the CIC Observation Reporting Interface
distributed by the National Committee for Clinical
Laboratory Science in the USA under Document POCT-1-A.
This option is installed by i-STAT Corporation.

Click Enable external interface box to check it and enable this function.
Click Enable AutoSend box to check it and enable this function. When
AutoSend is enabled, new records will be automatically sent from the Central
Data Station to another data management system whenever they are received
by the Central Data Station. Checking this box will cause the CDS program
to start up with AutoSend enabled on startup. AutoSend can be temporarily
enabled/disabled from the CDS program as well. Records can also be sent
manually from the Data Viewers.

Rev. Date: 07/12/04 Art: 714384-01C 22-11

 When MediSense Precision PCx glucose test strips are being run on the i-STAT 1
Analyzer, the glucose test strip data can be made available to QC Manager data
management program. Click the Upload PCx Strip Data to QC Manager 2.2
box to enable this function.

Options Confirmation message on exit: When this option is enabled, a confirmation

message is displayed prior to exiting the CDS program.
Enable use of IR Link IDs: When enabled, the IDs programmed into the IR
Links are used in determining the download location of the results instead of
the actual serial port or IP address. To use this function, all IR Links must be
of the self-identifying type. This option is not typically used but is available in
case the functionality is needed.
Accept previously deleted records: When disabled, this option prevents
previously deleted records from being stored when re-transmitted to the Central
Data Station.
Monitor refresh: The status reports in the Download and Interface Monitors
will be updated after the period of inactivity specified.
Maximum diagnostic files: Diagnostic files contain information that can be
useful in troubleshooting cartridge problems. The default number is 100 and is
changed at the request of a Customer Support representative.
Data Viewers: Selecting Save method selection on exit will cause each Data
Viewer to save whichever method was selected when the viewer is closed or
the Exit button clicked. The next time the viewer or CDS software is opened,
the saved method will be displayed. When Manually choose method before
viewer opening is selected, the user will be prompted to choose a method
before a data viewer is opened.
Automatic Database Backup: When enabled, the CDS database files will be
backed up to the selected location at the time of day entered. Should there be
a malfunction resulting in the corruption of the database, a Customer Support
representative may be able to retrieve the lost data from the backup copy. Each
backup replaces the previous one. Backup time depends on the size of the
database but usually does not take longer than 15 minutes.

22-12 Art: 714384-01C Rev. Date: 07/12/04

Security The security features allow for the creation of security profiles providing
different levels of access to various areas and functions of the CDS application.
Individual users can then be assigned to a security profile, and then choose
their own individual CDS log-on password. The system also has capabilities for
manual and automatic logoffs.
The security features should only be activated by the administrator of the System; i.e.
the person ultimately in charge of the CDS who will be creating the security profiles
and assigning users to them.
The security features can be activated by performing the following steps:

1. Check the box next to “Enable Security”.

2. After enabling security, the user also has the option of selecting an
inactivity interval after which the CDS will log off the current user.
Simply click on the “Log Off” box and use the up/down arrows to
choose the desired log off interval.
3. Click Accept at the bottom of the window.
4. A password dialog will then appear asking for a User Name and a
Password. Type the User Name of admin, and the password istat.
Then click on OK.
5. Another dialog box will appear prompting you to change your
password.

6. Type in a New Password of your choosing in the space provided. Then

retype that same password on the New Password Verification line and
click OK. This will automatically bring you to the CDS application.

Rev. Date: 07/12/04 Art: 714384-01C 22-13

22-14 Art: 714384-01C Rev. Date: 07/12/04
INTERFACE PROGRAM CUSTOMIZATION

Overview The Central Data Station can output results to an external computer system
such as an LIS or HIS. The Central Data Station also provides a function that,
when enabled, will also transmit all of the Precision PCx results generated on
the i-STAT 1 Analyzer to QC Manager so they can be managed as part of the
overall Blood Glucose Testing program.
The Central Data Station needs to be customized for the interface type using
the procedures below. Tabs are presented for the options available. Each
tab represents a protocol that the Interface Component of the CDS supports.
Depending on the particular installation, one or more of these will be used.

Procedure Exit the CDS application. Access the Run dialog box by clicking Start ➩
Run… Type c:\istat32\bin\interface32.exe at the Open: prompt, then
click OK. If Run… is not on the Start menu, double click the Command
Prompt shortcut. At the C:\> prompt in the window that opens, type
c:\istat32\bin\interface32.exe and press Enter. Click File ➩ Options. The
following screen will be displayed.
These tabs are used by the interface provider to configure the interface
Component of the CDS for the protocol that will be used.

Send Priority This function will prioritize the queue of results in the CDS database being
processed by the Interface Component of the CDS program. This capability
can be used by the interface provider to prioritize handling of results from one
location over another.

Rev. Date: 07/12/04 Art: 714384-01C 22-15

 Procedure 1. The CDS program must be running and the external interface must be
enabled.
2. Double click the i-STAT interface icon in the system tray (next to the
clock in the lower right hand corner of the screen) to open the interface
program’s main screen.
3. Click File ➩ Options...
4. Click the Send Priority tab. (The other tabs will be available for
viewing only.)
5. Click the Location/Method line to prioritize.
6. Right click under the Send Priority column and select the priority:
Normal, High, Very High, from the drop down list.
7. Click Accept to finish.

22-16 Art: 714384-01C Rev. Date: 07/12/04

OVERVIEW OF THE CENTRAL DATA STATION PROGRAM
The Central Data Station (CDS) software includes the following point-of-care
testing process management functions:

• Managing Instruments • Managing Analyzer

Customization Profiles
• Managing Operators • Maintaining Database
Contents and Size
• Managing Inventory • Monitoring External
Interface Activities
• Managing Policy • Monitoring Analyzer
Compliance Download Intervals
• Monitoring Operator • Managing LIS entry
Competence exceptions
• Reviewing Patient and
Quality Results

These functions are listed under the main menu option in four main groupings:
monitors, viewers, workspaces and reports.

Central Data Station

Software Function Monitor
Overview and Toolbar
Download
Buttons
Interface
Administration Tools (Workspaces)

Instrument/Location
Operator
Database Maintenance
Inventory
Customization
User Administration
Data Viewer

Results (patient)
QC Codes
Simulator
Unsent Records
Control Results
Calibration Verification
Proficiency Tests
Report

Reagent Management
Method Competence
Method Compliance

Rev. Date: 07/12/04 Art: 714384-01C 22-17

22-18 Art: 714384-01C Rev. Date: 07/12/04
ADMINISTRATION TOOLS

Overview Administration Tools include Workspaces for Instruments and Locations,

Operators, Database Maintenance, Inventory, Customization, and User
Administration.

INSTRUMENT AND LOCATION WORKSPACE

Overview This workspace is used to:

• assign names to download locations,
• assign instruments to locations,
• configure the reporting and monitoring options for each instrument,
and
• set required download intervals for each location.
The following sequence of tasks is used to set up the Central Data Station’s
management function for instruments:
1. Assign Location Names to Location Codes. Location Codes are the
physical port addresses for the download devices.
2. Assign Instruments to Download Locations.

Locations

❑ Edit Location Name

The location name can be changed from a letter/number code to the name of a
nursing unit, department, site, etc.. Up to 17 characters can be used to identify
a location. Click Location ➩ Edit Location Name... in the menu or click Loc.
Name in the toolbar.
Note: Interface logic should be considered before editing.

❑ Add New Download Location Assignment

Download locations can be added manually. Click Location ➩ Add
Download Location Assignment… in the menu or click the Add Assig. in
the toolbar. Download locations will also be added automatically when a
transmission is received from a download device with a location that is not
already on the list. The name assigned is A_xx, where xx is the download
device’s IP address or serial port. This name can be changed as described under
Edit Download Location Assignment.

Rev. Date: 07/12/04 Art: 714384-01C 22-19

 To assign instruments to a location without a download device, enter a
Location Name or another descriptive word as the Location Code.

❑ Delete Download Location Assignment

Click Location ➩ Delete Download Location Assignment... from the menu or
click Delete Assig. in the toolbar.

❑ Edit Download Location Assignment

Click Location ➩ Edit Download Location Assignment... from the menu or
click Edit Assig. in the toolbar.

Instruments Once physical download locations have been given location names, the
Instruments tab page will be the focus of management activities.

Location: Instruments are assigned to locations. This assignment is made

when an instrument is manually added in the Instruments page or when an
instrument downloads to the Central Data Station for the first time.
Method: The CDS is designed to accept results from any instrument that can
be downloaded to the CDS program. The i-STAT method in the Instrument
window refers to the i-STAT Portable Clinical Analyzer, the i-STAT 1 Analyzer
(both i-STAT cartridge and MediSense Precision PCx and PCx Plus Glucose Test
Strips) and the Philips Blood Analysis Module.
Clicking a Location/Method on the left side of the window will list the status of
all instruments for that location and method in the right side of the window. A
 symbol indicates which location and method has been selected.
Highlight Download Status: Checking this box will highlight locations with
instruments that have exceeded the required interval for downloading as well
as noncompliant instruments within the location selected.

22-20 Art: 714384-01C Rev. Date: 07/12/04

 ❑ Add Instrument
The Add instruments window is used to add an instrument to the system.
Click Instrument ➩ Add… from the menu or click Add Inst. in the toolbar.
Select a method from the drop down list.
Note: If using the i-STAT 1 Analyzer for cartridge and/or test strip runs,
select i-STAT as the method.

Select a location from the dropdown list. If the location is not listed, add the
location using the instructions under Add New Download Location Assigment.
If the location does not have a download device associated with it, such as an
instrument used for transporting patients, a location name can be typed in. (In
this case the Location Code on the Locations tab page will be SYSCODExxxxxx.)
Up to 17 characters can be used.
There are two options for Download Result Reporting, both of which apply to
the i-STAT PCA, i-STAT 1 Analyzer, and the Philips Blood Analysis Module:
1. Always report location as this assignment: The results from
this instrument will appear with the location of the instrument’s
assignment regardless of the download device used to transmit the
results. This option is useful when an instrument is assigned to
a functional group that may download from various areas in the
institution. The instrument will be designated “Assignment” under the
Reports column in the Instruments tab page.
2. Report location as download location: The results from this
instrument will appear with the location for the download device
that was used to transmit results to the Central Data Station. The
instrument will be designated “Download” under the Reports column
on the Instruments tab page.
If the instrument is not manually added to the list and it transmits to
the CDS, it is automatically assigned to the location of the download
device and is set to report “Download.” If the download device location
has not been manually added, a default location A_xx (B_xx, C_xx, etc.),
where xx is the IP address or serial port of the download device, will be
used.
There are two options for Download monitoring:
1. Include in download monitoring: Includes this Serial Number in
download monitoring.
2. Exclude download monitoring: The download status of the
instrument will not be reported by the Download Monitor. (Blood
Analysis Modules and infrequently used or spare analyzers might be
exempted from the Download Monitor report).

Rev. Date: 07/12/04 Art: 714384-01C 22-21

 ❑ Delete Instrument
Click the Location/Method for the instrument to be deleted and then the serial
number of the instrument to be deleted. Click Instrument ➩ Delete... from
the menu or click Delete Inst. in the toolbar.

❑ Move Instrument
Click the Location/Method for the instrument to be moved and then on the
serial number of the instrument to be moved. Click Instrument ➩ Move...
from the menu or click Move Inst. in the toolbar. Select the new location from
the drop down list or type in a new location.

❑ Find Instrument
Click Instrument ➩ Find... from the menu or click Find... in the toolbar. Enter
the serial number of the instrument and select the Method from the drop down
list.

❑ Edit Instrument Comment

Click the instrument serial number, click Instrument ➩ Edit Comment from
the menu or click Edit Inst. in the toolbar. Enter a comment of up to 16
characters.

❑ Change Current Instrument Setttings

Reporting: Click the instrument serial number. Click Instrument ➩ Current
Instrument ➩ Change Reporting from the menu or click the down arrow
next to Current Inst. and then Reporting in the toolbar to toggle between
Download and Assignment.
In Use: Click the instrument serial number. Click Instrument ➩ Current
Instrument ➩ Toggle In Use from the menu or click the down arrow next to
Current Inst. and then In Use in the toolbar to check (in use) or un-check (out
of use) the analyzer in the In Use column.
Instruments that are not checked “In Use” do not have a download criteria
applied to them. You would use this for instruments you do not expect to be
downloaded. When an analyzer that is not marked “in use” downloads, it is set
back in use and the download criteria is applied.
Monitoring: Click the instrument serial number. Click Instrument ➩ Current
Instrument ➩ Change Monitoring from the menu or click the down arrow
next to Current Inst. and then Monitoring in the toolbar to check or un-check
the analyzer in the Monitoring column.

❑ Add Instrument Note

Click Instrument ➩ Add Note... from the menu or click Add Note in the
toolbar. A note of up to 50 characters can be entered. The note will appear as a
Log Entry in the Instrument Log tab page.

❑ Change Download Monitoring Criteria

Compliance to download policy can be monitored by the CDS program. Click
on the Location/Method. Click on Instrument ➩ Download Criteria... from
the menu or click Criteria in the toolbar. Enter the required download interval.
An interval of up to 1000 hours is allowed.
Compliance with the criteria can be observed by checking the Highlight
Download Status check box or by going to the Download Monitor. Individual
Download criteria can be set for each location and method pair.

22-22 Art: 714384-01C Rev. Date: 07/12/04

 Note: The i-STAT 1 Analyzer can also be customized either to warn the end
users that a download is required or to lockout end users if the time
for a download has been reached or exceeded. The download criteria
for analyzers and for the CDS monitor should be selected to make
sense.

❑ Instrument and Location Summary

The Instrument and Location Summary provides a report of the current
instrument assignments and the last download for each instrument. Click
Main ➩ Open Report ➩ Instrument Summary from the menu or click the
down arrow next to Report and then Summary in the toolbar. Summaries can
be viewed and printed by:

• This method and location only (location and method selected with 
symbol)
• This method, all locations (method selected with  symbol)
• All methods, all locations

Rev. Date: 07/12/04 Art: 714384-01C 22-23

 Instrument Log The Instrument Log tracks all changes made in the Instruments tab page.
Additional comments can be added to the log by clicking Add Note in the
toolbar.

❑ Date Range...
Data can be viewed within a user defined default range or by a manually
entered range.

❑ Delete...
The Delete button allows selected or all entries within the date range selected
to be deleted.
To print the log press the F2 key or select Print from the Main menu or toolbar.

22-24 Art: 714384-01C Rev. Date: 07/12/04

OPERATOR WORKSPACE
Overview This workspace is used to:
• Record operator names and identification numbers
• Record certification dates and certification expiration dates
• Assign operators to departments
• Add comments

When the i-STAT 1 Analyzer is customized to use the operator list created here,
the analyzer can be customized to warn or lockout operators if they are not on
the list or their certification has expired.

Operators Operators are listed by Department and Method as indicated by thesymbol.

Operators are added to the operator list by department and by method.
When a record is received with an Operator ID that is not listed in any
Department, the operator is placed in the “Unassigned” department.

❑ Operator list edit in progress

When editing the operator list, check this box to delay updating i-STAT1
analyzers until all editing is complete. When editing is complete, click the
box to remove the checkmark. This box will appear when Serial or Network
Communications are enabled, Customization is enabled and Use Operator List
is enabled.

Rev. Date: 07/12/04 Art: 714384-01C 22-25

 ❑ Add Operator
This function is used to add new operators to the list of operators. Alternatively,
operator lists can be imported (see Operator List Import at the end of this
section). Click Operator ➩ Add... from menu or Click on Add in the toolbar.

Enter the ID number that the operator will enter into the analyzer on the
Operator ID line. If a different ID number is used to access the LIS, this number
should be recorded on the Alternate ID line. An Operator Name of up to 40
characters can be entered. A comment of up to 16 character can be added. If
operators are to be certified for more than one method, such as for the i-STAT
cartridge and the PCx glucose test strip, certify each operator for one method
and use the Add Cert. toolbar button to certify all applicable operators at
one time for the method. To add the first operator to a department, type the
department name (up to 10 characters). Once a department has been added, it
can be selected for additional operators from the drop down menu.
Check the Clear Operator data when "Add and Remain Open" clicked box to
specify whether or not the operator information fields should be cleared when
the Add and Remain open button's clicked.

❑ Delete Operator
Select the operator or operators. Click Operator ➩ Delete... from the menu or
click Delete in the toolbar to delete the operator or operators. When the last
operator from a department is deleted, the department is removed from the
system.

❑ Move Operator
Select the operator or operators. Click Operator ➩ Move... from the menu or
click Move in the toolbar, and select a new department from the drop down
list. If the department is not in the list, type in the new department name.

❑ Find Operator
Click Operator ➩ Find... from the menu or click Find in the toolbar, select the
method for which the operator is certified, and type in the operator ID. A box
will appear around the found operator.

❑ Edit Operator Data

Click the operator. Click Operator ➩ Edit from the menu or click Edit in the
toolbar. The operator ID, name, comment and alternate ID can be edited.

22-26 Art: 714384-01C Rev. Date: 07/12/04

 ❑ Update Certifications
Select the operator or operators. Click Operator ➩ Update Certification...
from the menu or click Update Cert. in the toolbar and complete the Update
Certification form.

❑ Add Certification
The Add Certification button allows operators who are certified for one
method to be certified for another method without having to complete a new
Add Operator form. Highlight the operator or operators in the Operator tab
window that are to be certified for another method. Click Operator ➩ Add
Certification... from the menu or click the Add Cert. button on the toolbar.
Select the other method for which these operators are to be certified, then
specify the certification dates.

❑ Add Note
Click the operator. Click Operator ➩ Add Note... from the menu or click Add
Note in the toolbar. An Operator Log Note of up to 50 characters can be typed.

Rev. Date: 07/12/04 Art: 714384-01C 22-27

 ❑ Edit Department Name
Click the department name to edit. Click Operator ➩ Edit Department
Name from the menu or click Dept. Name in the toolbar. The Unassigned
designation cannot be changed.

❑ Operator and Certification Reports

Click on the down arrow next to Report in the Operator Workspace toolbar
and click on Summary or Expiration.
Operator Summary: Summaries of operators can be viewed and printed by:
• This method and department only (department and method selected
with  symbol)
• This method, all departments (method selected with  symbol)
• All methods, all departments
The reports include operator IDs, operator names, certified from date,
certified until date, comments, a checkmark if certification has expired
and the operator’s alternate IDs grouped by department and method.
Operator Certification Expiration: This report allows the certification status
of operators to be viewed.

22-28 Art: 714384-01C Rev. Date: 07/12/04

Operator Log The Operator Log tracks changes made and “Add Note” entries made in the
Operator tab page. The Date Range… button can be used to specify a time
period to be viewed and the Delete… button to delete entries. To print the log
press the F2 key or select Print from the Main menu.

Rev. Date: 07/12/04 Art: 714384-01C 22-29

22-30 Art: 714384-01C Rev. Date: 07/12/04
OPERATOR LIST IMPORT
This function in the Operator Workspace on the CDS5 allows an operator
list to be imported from a text file. To access this function, click on Main ➩
Open Administration Function ➩ Operator from the main menu to open the
Operator Workspace. Select Operator ➩ Import List… from the main menu
to open the Import Operator List window. This window is used to describe the
format of the text file containing the list to be imported into the CDS.

Import List 1. Under Fields in text file:, use the mouse to drag and drop the field
Instructions names so they match the order in which the fields appear in the text
file containing the list to be imported. If a field does not appear in the
text file, drag it to the Available fields: list. If the text file contains a
field that should be ignored, drag a SkipField(x) field to the Fields in
text file: list to mark where that field appears.
2. Fields in the text file containing the list to be imported must be
separated by a comma or other delimiter character. Specify the
separator in the Delimiter character box.
3. If a qualifier character is used to enclose the data contained in each
the field in the text file containing the list to be imported, select this
character from the Text qualifier: list.
4. If the first line of the text file is a header line listing the names of the
fields in the text file containing the list to be imported, click Skip
first line of file (file contains headers). The import function cannot
process header lines.
5. If all operators in the text file containing the list to be imported are
to be certified for one method, click Assume a test method for all
operators and select i-STAT for cartridge testing or Precision PCx
for the MediSense Precision PCx or PCx Plus Glucose Strip testing on
the i-STAT1 Analyzer. If this option is selected, the text file does not
need to contain a Method field. If this option is selected and the
text file does contain a Method field, its contents will be ignored
6. If all operators will be certified from the same date, click on Assume a
certification start date for all operators and enter the start date. If
this option is selected, the text file does not need to contain a Certified
from field. If this option is selected and the text file does contain a
Certified from field, its contents will be ignored.
7. If all operators are to be assigned to the same department, such as
Nursing or Perfusion, click on Assume a single department for all
operators and enter or select the department from the drop down
list. If this option is selected, the text file does not need to contain
a Department field. If this option is selected and the text file does
contain a Department field, its contents will be ignored

Rev. Date: 07/12/04 Art: 714384-01C 22-31

 Example from list to be imported:
“ICU”, “12345”, “Smith, Judy”, “none”, “98765”, “i-STAT”, “2001-08-
08”, “2002-08-08”
8. Click Select File… and select the name of text file containing the list to
be imported.
9. Click Import File to import the list from the text file.
Note: operator data that already exits in the CDS5 database takes
precedence over any data imported from a text file.

Export List After a list has been imported or created, it can be exported for backup
purposes.

22-32 Art: 714384-01C Rev. Date: 07/12/04

DATABASE MAINTENANCE
Overview This workspace allows the database to be backed up, deleted and restored. A
"Statistics" tab page also allows users to view a summary page of Result Types
contained in the database.

Archive Test Results Backup test results: This function allows test results to be backed up onto a
disk, CD or other directory. (Note: a 1.44MB disk will only store about 1000
test records.)
1. Click on Main ➩ Open Administration Functions ➩ Database
Maintenance.
2. After the workspace opens, click the Archive Test Results tab.

3. Click the Backup test results radio button.

4. Specify a date range for the function.
5. Select a Backup Option: Backup, Backup and Delete, or Delete only.
6. If an option that includes Delete is selected, then select a Delete
Option: Delete details data only or Delete details and demographic
data. Details data includes:
• Original Operator and Patient ID
• Patient Name
• LIS order number
• Sent status
• Analyte values
• Extra data
Demographic data can be used to generate reports. Demographic data
includes:
• Test type (test result, simulator, proficiency,...)
• Test panel (such as EC8+, CG8+, PCx Glucose)
• Test Method (i-STAT, Precision PCx...)
• Patient ID
• Operator ID
• Test date/time
• Location

Rev. Date: 07/12/04 Art: 714384-01C 22-33

 • Comment
• Interface comment
• Serial number
• Department
7. Select a Directory.
8. Select a method or methods to back up or click Select all methods.

9. Click the button marked Backup or Backup and Delete and follow the
prompts.
Note: When results are being deleted as part of a backup and delete or a delete
only operation, the deletion can be cancelled. Simply click on the Cancel
button to stop the operation. Once the Cancel button is clicked, depending
on the amount of data being deleted and the size of the database, there may be
a significant lag time of a few minutes before a dialog box appears indicating
that the deletion has been paused, asking you to select one of three options:

The reason for the lag time is that the program needs to complete whatever
portion of the deletion operation it was performing when the Cancel button
was clicked before it can display the dialog box. Once the dialog box is
displayed, simply click on the desired radio button and then click OK.

22-34 Art: 714384-01C Rev. Date: 07/12/04

 Restore test results: This function allows test results that have been deleted
from the CDS but backed up elsewhere to be restored to the database.
1. Click on Main ➩ Open Administration Functions ➩ Database
Maintenance.
2. Insert disk or CD where files are located.
3. Click the Restore test results radio button.
4. Select the directory for the stored results.
5. Select the method or methods to be restored.
6. Select a restore option: Restore demographic data only or Restore
demographic and details data. (Demographic data can be used to
generate reports.)
7. Select the files to be restored or select all files.
8. Click the Restore button.

Database File Backup Database File: This function allows the user to manually perform the
same operation that occurs when the automatic database backup occurs. It
creates a complete backup of the database file to the specified drive/directory.

Compact Database File: When the backup and delete or delete only functions
are executed, the deleted data is removed from the database but the disk space
the data occupied in the database file is not. The compaction function creates
a new copy of the database with the excess space removed, creating a smaller,
better organized and, therefore, more responsive database. If CDS functions
such as opening or refreshing a data viewer grow noticeably less responsive
over time, compaction of the database may help. It is recommended that
compaction function be executed at least once a year.

Statistics A “Statistics” tab page allows users to view a summary page that lists:
1. The total results in the database,
2. The date and time of the oldest result in the database,
3. The date and time of the newest result in the database, and
4. A breakdown of the total results in the database by Result Type and
Method.

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 Selecting an individual Result Type and then clicking on Details allows you to
view a similar statistical breakdown for that particular Result Type:
1. The total number of that particular Result Type in the database,
2. The date and time of the oldest result of that type in the database,
3. The date and time of the newest result of that type in the database,
4. A breakdown of the number of this particular result type that have
been sent successfully (Yes), unsuccessfully, or not sent at all (No) to the
LIS/HIS. Note: a listing in this window for “Not Available” indicates
that there are records of this type in the database where the details data
have been deleted, so the application cannot determine whether that
particular record was sent or not.

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INVENTORY WORKSPACE

Overview The Inventory Workspace is organized under five tabs with the following
functions:

• Stock: define reorder triggers, view and edit inventory

• Distribution: track items distributed from central stock to different
locations
• Items: define inventory items
• Orders: track pending and received orders, view reports on received
items
• Inventory log: view a log of major user actions
Populate the Items tab first, followed by the Stock tab where current inventory
should be entered and reorder triggers defined.

Items The Items tab is used to define the inventory items for the i-STAT System and
other point-of-care tests.

To select an item available from i-STAT and its distributors, highlight the item
in the Choose items from the list on the right side of the window, then
click the arrow next to the Add button in the tool bar and click the Selected
button. The item will move to the Available items list on the left side of the
window.

To add an item not available from i-STAT and its distributors, click the arrow
next to the Add button in the tool bar, then click the New button and
complete the displayed information form.

To delete an item from the Available items list, highlight the item, then click
the Delete button in the tool bar. If the item was selected from Chose items
from the list, the item will be moved from Available items back to this list.

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 To edit information under the Available items list, click the Edit button in the
tool bar.

Stock The Stock tab includes both Inventory and Estimated Inventory statistics.

Inventory: The number of given items as counted and entered by the user.
The inventory is automatically updated when new orders are received under
the Orders tab.

Estimated Inventory: The number of i-STAT cartridges and MediSense PCx

and/or PCx Plus glucose test strips as estimated by the workspace software. The
initial Estimated Inventory is taken from the Inventory column. Every time a
cartridge or glucose test strip result is transmitted to the Central Data Station
software, the count of the estimated inventory decreases by 1. The Estimated
Inventory is automatically updated when new orders are received under the
Orders tab. The Estimated Inventory item count is adjusted to the Inventory
count whenever the Inventory column is manually edited.

Startup Option The items added under the Items tab will be listed under the Stock tab
with Inventory and Reorder set to 0. There are two ways to populate the
Inventory column.

1. Count current stock. Go to the Stock tab, click on the Edit button in
the tool bar, and enter the current inventory. Lot numbers and Expi-
ration dates will not be tracked for inventory entered by this method.

2. Count current stock along with lot numbers, expiration dates and lo-
cations. Go to the Order tab and enter and receive the POs for the ex-
isting stock. Go to the Stock tab and manually adjust the Inventory to
the current stock count. (Alternatively, receive only the current stock
count.) This option allows the user to take advantage of the lot num-
ber and expiration date tracking capabilities of the workspace.

Click on the Edit button on the tool bar and enter the reorder trigger numbers.

Click a check mark next to Highlight items to be reordered. Items that need
to be reordered will be highlighted. (See CalVer Set in illustration below.)
Reorders are highlighted based on the Estimated Inventory.

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 The inventory can be edited by highlighting the item and clicking the Edit
button or by clicking the Adjust Invent button, selecting the item from the
drop down menu, and adding or subtracting units. When the Inventory
is edited, the Estimated Inventory is automatically made equal to the
Inventory.

The Estimated Inventory for i-STAT cartridges and MediSense PCx glucose test
strips will automatically begin updating with the next analyzer transmission.
Click the Refresh button to update the workspace for transmitted data. Both
the Inventory and the Estimated Inventory are updated automatically when
orders are received under the Orders tab.

Periodically, the Estimated Inventory should be updated manually. This is

necessary to account for other consumables as well as for cartridges and strips
that are discarded before testing, such as expired inventory. Click the Estim.
Invent. button in the tool bar to adjust the Estimated Inventory.

Orders To record a new order, click on the New button in the tool bar. Select the
item from the drop down menu under Item and enter the quantity. Click the
Add Item button to add another item or the Delete Item button to delete an
item.

To enter information about a received order right away, click on the Receive
Order button. To enter information about a received order later, click the
Order Pending button.

To receive an item or to edit order information, click the Edit/Receive button

in the tool bar. Highlight the PO Number and enter the Order Details.

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 Note: The lot number and expiration date are used in the Distribution
tab. Therefore, PO, lot number and expiration date information for
consumables in inventory should be entered here. The PO number
field can accommodate up to 20 characters.

Click the Add Button to add another item or the Delete Button to delete an
item. Click the Receive All Button to automatically enter items and quantities,
as they were ordered.

Use the Delete button on the tool bar to delete an order.

Use the Find Lot and Find Next buttons on the tool bar to find the PO
associated with a received lot.

Use the Delete Lot button on the tool bar to delete a lot number that has
expired or has been used up.

The Report button on the tool bar is used to view all received items by date
range.

Use the Add Note button on the tool bar to add a note to the Inventory Log.

22-40 Art: 714384-01C Rev. Date: 07/12/04

Distribution Use the Add button in the tool bar to record the distribution of consumables.
The Item drop down menu includes all consumables entered in the Items
tab. The Location drop down menu includes all locations entered in the
Instrument and Location Workspace. The Lot Number drop down menu
includes lot numbers for the selected items received in the Order tab. The
expiration date is entered automatically. A comment of up to 16 characters
can be entered.

The Distribution tab will list each location with its consumables. Define an
alert date and click a check mark next to Highlight items expiring within xx
days to alert you to transfer stock to a different location where it can be used
before its expiration date.

Use the Delete button on the tool bar to delete a distribution.

Use the Transfer button in the toolbar to move consumables from one
location to another.

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 Use the Find Lot button to find a location where a consumable of a specific
lot has been distributed. Click the Find Next button to find other locations
for this lot.

Use the Add Note button to add a note to the Inventory Log.

Inventory Log The Inventory Log documents each action taken in the Items, Stock,
Distribution and Orders tabs. Click the Date Range button in the toolbar to
select the a Default date range or a Start and End date for this report. Click
the Delete button to delete entries in the log.

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CUSTOMIZATION WORKSPACE
Overview This workspace is used to create profiles with site specific test characteristics for
the analyzers. See the Customization section of this manual for details of items
that can be customized and their default settings.

Password The Customization Workspace is password protected. If the Security feature

is disabled, the default password is istat. If the Security feature is enabled,
the user uses the same password as their CDS application logon password. To
change the password, select Tools and Change Password from the menu bar.
A password from 3 to 8 characters can be used.

Enabling To enable customization, click the box to check it. When customization is
Customization enabled, the Central Data Station will check the Customization Profile for
the location each time an analyzer is downloaded. If the location has the
Enable Updates option checked, the Central Data Station will update the
analyzer with the current Customization Profile for that location as noted below.
• Analyzers designated to Report location as download location in the
Instrument workspace will be updated with the Customization Profile
assigned to the download location, regardless of the location to which
the instrument is assigned. Care should be taken when downloading
instruments from locations other then their assigned location.
• Analyzers designated to Always report location as this assignment in the
Instrument workspace will always be updated with the Customization
Profile for the instrument’s assigned location, regardless of the physical
location from which it downloads.

If a location has the Enable Updates option unchecked, downloading

from that location will result in no customization changes being made to
analyzers designated to Report location as download location. Analyzers
designated to Always report location as this assignment will not be updated
if the assignment location for the instrument has the Enable Updates option
unchecked, regardless of the setting associated with the physical location from
which it downloads.
User can also disable/enable CLEW updates by location. The default setting
is to have the CLEW updates occur automatically for all locations. To disable
a particular location, simply click on the corresponding check box under
Update CLEW to remove the check mark. Disabling CLEW updates may help
protect users from getting Code 13-Invalid or Expired CLEW on their analyzers
following a software upgrade, should they forget to update the CLEW in the
Customization Workspace following the software upgrade procedure.

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 Default The first step in customization is to create a default customization profile. This
Customization Profile is the profile initially assigned to every new location. To change the default
profile, use the directions under Making Selections or click the menu option
Profile ➩ Change Default and the item to be changed. The changes in the
default profile are automatically applied to every location using the default profile.

Location-based Different customization profiles can be created for different locations. Uncheck
Customization the Use Default Profile box for the location and double click i-STAT Analyzer
Profiles CLEW or BAM CLEW to change the CLEW or double click Preferences to
change any of the preferences. Alternately, select the menu option Profile
➩ Change Location-Based and the item to be changed. Changes in the
customization profile can be made for several locations at once by selecting the
locations and then selecting the appropriate option from the Profile Menu. If a
location has the Use Default Profile option checked, its customization settings
will not be changed even if it is selected. Note that Language and the Unit Set
from the default customization profile are always used.

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 Preferences for locations can also be changed by selecting an existing preference
from the Apply Preferences submenu. Select the location or locations to be
changed. Click Profile ➩ Apply Preferences. Select the desired preferences
and click Apply. Click View Preferences to review a set of preferences.

Making Selections Selections are made from options in the following ways:
• Select one of the five main Customization options by double clicking
the box for Language, Unit Set, i-STAT Analyzer CLEW, BAM CLEW
or Preferences.
• After making a selection in the Language, Unit Set and CLEW window,
click the OK button to save the selection or click the Cancel button to
return to the previous selection.

Language Window

Note: Russian is available only on the i-STAT Portable Clinical Analyzer and
Portuguese, Danish, and Finnish are available only on the i-STAT 1
Analyzer.

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 Unit Set Window Details of each unit set are displayed under the Analytes column. Details are
also listed in the Customization section in this manual.

To create a unique unit set, click UNITSET99 and then the User Settings tab.
Then select the name and units for each analyte or test.

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CLEW Window

A new CLEW is added to the window via the software update process three
times a year. If the Update CLEW feature is active, the Default customization
profile must be updated after each new CLEW is added. Click the new CLEW
and click OK. Note that there are separate CLEW for the i-STAT analyzer and
the Philips Blood Analysis Module.
Note: Before changing to a new CLEW ensure that all analyzers have been
updated to a compatible application software version.

Preferences Window

For detailed descriptions of the preferences, see section 9, Customization. The

Preferences Window has six tab pages. Click the tab to display the desired
page. The following conventions are used in the Preferences pages:
• Enable/disable an option by clicking the check box to check/uncheck
it.
• Change a numeric setting by clicking and holding the  or  symbol
or manually entering the number.

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 • Select an option from a list by clicking the ‚ and selecting the option
from the list.
• Select from multiple options by clicking the radio button next to the
desired option.
• Enter values into fields, such as for Reference Ranges and Strip Lot
Numbers.

When all information has been entered, a button is pressed:

• Default Values will restore the default settings to the open window.
• OK will store the new settings.
• Cancel will ignore any new settings and restore the current settings.
Each Customization Profile is assigned a unique name by the CDS program.
This name appears under the Preferences column in the Customization
Workspace window, on the Customization screen on the i-STAT 1 Analyzer, on
the Analyzer Status screen on the i-STAT Portable Clinical Analyzer and on the
Blood Analysis Setup screen of the Blood Analysis Module.
A description can be associated with a profile using the Description field in the
Preferences Window.
Caution: Close the Customization Workspace when finished to prevent
inadvertent changes.

Backup and Restore The current customization profile can be stored by selecting Profile ➩
Profile Backup… from the menu bar or by clicking the Backup toolbar button,
selecting the directory where the profile is to be stored, typing in a file name
for the profile, and clicking the Save button.

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 To restore a profile to the CDS, click Profile ➩ Restore… or the Restore toolbar
button. Select the directory and backup file to restore and click the Open
button.

Rev. Date: 07/12/04 Art: 714384-01C 22-49

22-50 Art: 714384-01C Rev. Date: 07/12/04
USER ADMINISTRATION WORKSPACE
Overview The User Administration Workspace is designed as a tool for system
administrators. It allows administrators to manage security profiles (a set
of security settings determining the access to different CDS screens and
functions), manage users, and assign users to security profiles.

Access Only users designated as administrators can access the User Administration
Workspace in the CDS by clicking on Main ➩ Open Administration Function
➩ User Administration. A Password dialog will then appear. Type in your
CDS log-in password and click on OK.

Creating Security Once the User Administration Workspace is activated, the Administrator will
Profiles need to determine how many different security profiles are needed for their
facility, and what workspaces and functions should be available to users at
those different security levels. Once those decisions have been made, the
next step is to create the desired security profiles in the User Administration
Workspace.
Please note that an Administrator profile will always exist in the User
Administration Workspace. It cannot be edited or deleted, and allows access
for those designated users to all CDS Workspaces and functions.
To create a new security profile: click on Profile ➩ Add. An “Add Security
Profile” dialog will then appear.

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 Type in the name of the new Security Profile, then check off the different
workspaces and functions users assigned to that security level will be allowed
to access, and then click OK. The newly created security profile will then be
added to the Available Security Profile list.

Deleting Security To delete an existing Security Profile, click on the profile you want to delete in
Profiles the Available Security Profiles window. Click on Profile ➩ Delete, and answer
“Yes” to the confirmation message that appears on the screen.
Please note that a Security Profile can only be deleted if all of the Users assigned
to that particular profile have first been deleted from the Users window. If all
of the users have not first been deleted, “Error Accessing Database” and “Error
Deleting Profile” messages will appear.
The Administrator Security Profile is permanent and cannot be deleted.

Editing Security To edit an existing Security Profile, click on the profile you want to edit in the
Profiles Available Security Profiles window. Click on Profile ➩ Edit. The name of the
profile will then be highlighted in blue. If you wish to edit the profile name,
simply type in the new profile name. Then select or deselect the desired listings
under the “Security Options for Selected Profile” window by clicking on the
corresponding check box.
When all edits are complete, simply click on Profile ➩ Edit, and answer Yes to
the confirmation message that appears about saving the new changes.

Adding Users Once all the Security Profiles have been created, the next step is to create users
and assign them to the various security profile levels.
To add a user to a security profile when in the User Administration Workspace,
click on User ➩ Add.... An Add User box will then appear on the screen.

Type in the User Name in the first line, then choose the appropriate Security
Profile from the drop down list and click OK. The new user listing will then
appear in the User window.

Deleting a User To delete a user, select the user to be deleted, click on User ➩ Delete, and
answer Yes to the confirmation message. Note: the user who is currently
logged on cannot be deleted.

Assigning a User to a To assign an existing user to a different Security Profile, click on User ➩ Assign
Different Profile Profile. A drop down menu will appear next to the user’s name. Simply
click on the desired Security Profile, then click on User ➩ Assign Profile, and
answer Yes to the confirmation message that appears asking if you want to save
changes.

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PASSWORD MANAGEMENT
Passwords Once all the Security Profiles are created, and all CDS users are assigned to the
appropriate Profiles, the Administrator should provide the users with their
assigned User Names. Their initial password is istat.
When a user logs on to the CDS application for the first time, a dialog box
asking for a User Name and Password will appear. They should input their
assigned User Name supplied by the Administrator, and the password istat. A
dialog will then appear indicating that they must change their password. After
clicking on OK, the following dialog will appear:

The user should type in a unique password of their choosing in the space
provided, then retype that same password on the New Password Verification
line and click OK. The password must have a minimum length of
3 alphanumeric characters, and a maximum length of 12 alphanumeric
characters.
Once the password is changed, the user will then use their new password for all
subsequent CDS log-ons.

Emergency Passwords If a user forgets their User Name or Password, they have two options for
accessing the CDS application:
1. If available, the Administrator can log onto the User Administration
Workspace and look up the User Name from the User Window. An
Emergency Password for this particular user can then be obtained by
performing the following:
a. Click and highlight this particular user’s listing in the User
Window.
b. Click on User ➩ Emergency Password. A box will appear with
an Emergency Password that this particular user can use. Note:
Once this user uses the Emergency Password to log in, they will be
immediately prompted to change their password for future CDS
log-ins. They cannot continue to use the Emergency Password for
log-in purposes.

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 2. If the Administrator is not available, the user can contact their local
Support Representative for an emergency User Name and/or password.
As with option 1 above, once this user uses the Emergency Password
to log in, they will be immediately prompted to change their password
for future CDS log-ins. They cannot continue to use the Emergency
Password for log-in purposes.

Changing a Password If a user is logged on to the CDS application, they can choose to change their
password at any time by clicking on Tools ➩ Change Password. A dialog
box will appear asking them to enter their Old Password, as well as their New
Password (twice). After entering this information, the user clicks on OK and
answers Yes to the question that appears asking if they really want to change
password.

SYSTEM LOGOFFS
Overview The CDS provides the capability for manual and automatic user logoffs. In the
logged off state, the majority of CDS screens and functions are not available.
However, analyzer and BAM data can continue to be transmitted to the
application, and subsequently sent to the LIS/HIS (if applicable). Also, the
monitors remain open if they were open prior to logoff.

Manual Logoff Once a user has completed their CDS tasks, they can log off by clicking on
System ➩ Log Off. A box will then appear on the screen indicating that the
current user has logged off.

Automatic Logoff Automatic logoffs are optional and can be enabled in the i-STAT CDS
Customization screen, as described in the Security section above on page 22-13.

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DATA VIEWERS
Overview Data from instruments downloaded to the CDS are viewed in the Data Viewers.
Data downloaded from the i-STAT 1 Analyzers can be viewed in separate Data
Viewers for Results, QC Codes, Simulator, Unsent Results, Control Results,
Calibration Verification (or Linearity) Results and Proficiency Results (external
quality control).
Control, Calibration Verification and Proficiency Results from the Portable
Clinical Analyzers and Blood Analysis Modules will appear in the Results Data
Viewer.

Data from the Medisense Precision PCx Plus Glucose Test Strips can now be
viewed in the Data Viewers, alongside the data from the Precision PCx strip.
To determine which strip type was used on a particular testing run, look at the
column entitled Panel. Precision PCx Plus strip runs will be labeled PCx Plus
Glucose, while Precision PCx strip runs will be labeled PCx Glucose.

Information in Data Data for only one method at a time, such as the i-STAT cartridges, is displayed
Viewers in a viewer. To switch to a different method, select the method from the
selection list in the lower left corner of the viewer. The exception is the Unsent
Results Data Viewer which displays results from all methods. Records are listed
based on which column is being sorted. Data can be displayed in ascending or
descending order by clicking a column as described above.

Example: Results Data Viewer

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 Refreshing the Data Data is received continuously by the CDS. Updating the viewers with the
continuous incoming stream of data would make viewing the data difficult.
Therefore, new data is not added to a viewer until the Refresh button is pressed.
The window can also be refreshed by pressing F5 or selecting Refresh from the
Window option menu on the menu bar. The date and time of the latest refresh
are listed on the bottom right of the window.

Viewing Details The details of records in the Results, Control, Cal/Ver, Proficiency and Unsent
Results Viewers can be viewed by double clicking the record, by selecting the
record and clicking the Details toolbar button, or by selecting Record ➩ View
Details… from the Menu.
Many of the Extra Data details may be helpful to the Customer Support
representative in troubleshooting.

Example of Details for Results Viewer

Customizing the Data The viewers can be customized for individual preferences. The following
Viewers aspects of the viewers are user configurable.

❑ Selecting a Date Range

The initial default date range for data in a viewer is the current date and back 7
days. The initial default range can be changed by selecting Tools ➩ Customize
Viewer ➩ Date Range… from the text menu, or by clicking the arrow next to
the Customize toolbar button, then the Date Range button. A default date
range can be set but overridden by entering a different date range for display.
The maximum default date range allowed is 999 days.

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 The selection of a shorter date range enhances the system performance by
limiting the amount of information needing to be presented. It is always
possible to expand the range to view results from earlier and then reset to
a more limited default period. The date range function only limits what is
presented, not what is in the database.

❑ Selecting Columns to View

Columns can be hidden. Select Tools ➩ Customize Viewer ➩ Display
Columns or click the arrow next to the Customize toolbar button, then the
Columns button. To hide a column, click the box following the column’s
name to uncheck it and then click OK. To make the column visible again,
click the empty box following the column’s name to check it and click the OK
button.

The Raw Location and the Receive Date/Time columns allow users to track
the location where particular analyzers are being downloaded, plus the time
intervals in which users are transmitting data to the Central Data Station.

❑ Sorting Data
For customers who want to sort data in the Data Viewers by multiple column
criteria, a new multilevel sorting feature has been added. To access this feature,
open the desired Data Viewer, click on Tools ➩ Customize Viewer ➩ Sort...,
or click the arrow next to the Customize toolbar button, then the Sort button.

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 A two-sided Sort dialog will then appear, listing Columns Available for
Sorting on the left, and Sort Columns on the right. Simply click the listing
under Columns Available for Sorting that you wish to sort your data by, and
then drag that column title to the right hand side of the screen under the Sort
Columns section. Once all of the columns you wish to sort by are under the
Sort Columns section, check whether you want that particular column to be
sorted by ascending or descending order, by placing or removing the check
mark in the Ascending box.
Once all selections have been made, simply click on OK and the sort process
will be completed, taking you back to the Data Viewer screen.
Note: By default, the Date/Time column is automatically placed under the
Sort Columns section with descending order selected. If you do not wish to
sort by Date/Time, simply click on that column listing and drag it back to the
left side of the screen under Columns Available For Sorting.

Editing a Record To edit a record, highlight the record to be edited, click Record ➩ Edit Record
in the menu bar or click the Edit toolbar button.
Different viewers have different editable items. Results that have been
successfully sent to the LIS or HIS have only an editable Comment. Results
marked as Pending or In Progress cannot be edited.
The Patient ID, Patient Name, Operator ID, Comment, Interface Comment
and Order Number can be edited in the Results Viewer. Use the Tab key or
the mouse to move across the line. The original Patient and Operator IDs will
appear along with the edited IDs in the Details window.

Finding a Record Different viewers have different lists from which to select for a search based on
the data presented. Click Record ➩ Find... on the menu bar or click the Find
toolbar button. Selecting Sort before finding before clicking OK will present
the records in ascending order for the value after the first record matching the
search is found.
Type on the Value line the desired parameter then highlight that parameter and
click OK to find.

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Printing Selected With a Data Viewer open, highlight the records to be printed, click Record ➩
Records Print Selected Records or click the Print toolbar button.

Send Selected With a Data Viewer open, highlight the records to be sent, click Record ➩ Send
Records Selected Records or click the Send toolbar button.

Trending Results Results records in the Results, Control Results, Cal/Ver Results, Proficiency
Results and Unsent Results Viewers can be selected for Trend reports. Trends
can be performed on Patient ID, Control Lot Number, Calibration Verification
Kit Number, Proficiency ID, Operator ID, Analyzer Serial Number or by a
selection of records.
With the Data Viewer open, click Record ➩ Trend, then the trend option from
the menu bar or click the arrow beside the Trend toolbar button and click the
desired trend option. Up to 25 records are presented from oldest to newest
data.
To trend by selection, highlight the records to be included in the trend report
then perform the Trend function.

Example of a Result
Trend by Patient ID

QC Codes Viewer All Quality Check Codes are listed in chronological order. To add a comment,
click the record, then Record ➩ Edit Record on the menu bar or click the Edit
Record toolbar button. To sort the Quality Check Codes by type, click the
Quality Code column header. To list again in chronological order, click the
Date-Time column header.
Note: Panel is a binary code for the cartridge types.

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 Electronic Simulator All Electronic Simulator results, both external and internal, are listed in
Viewer chronological order with the newest result at the top of the screen. To view all
simulator results together for each analyzer, click the Serial Number column
header to sort the analyzers by serial number or use the Find... option and
sort for one analyzer. To list in chronological order again, click the Date-Time
header.

To view the actual readings taken during the Electronic Simulator check, click
Record ➩ View Extended Simulator Report... Note that the Simulator ID and
Probe Delta columns can be viewed in the screen above by scrolling to the right.

Unsent Records This viewer is available only if an external interface installed by i-STAT is
Viewer enabled in the Central Data Station Customization function. This data viewer
displays records that have not been sent from the Central Data Station to an
external computer system, such as an LIS. The incorrect information can be
corrected using Edit and the corrected record resent.
Unsent results can be removed from the viewer by highlighting the record,
clicking on Record ➩ Mark Selected Records as Sent, or by pressing the F8
Key.

22-60 Art: 714384-01C Rev. Date: 07/12/04

MONITORS
Download Monitor The download monitor quickly identifies the download status of all locations
and any locations that have instruments out of download compliance.
The upper portion of the monitor shows the last time an analyzer from the
listed locations was downloaded. These columns can be sorted by clicking the
column heading.
The maximum time allowed between downloads from the instrument to
the CDS is defined under Download Criteria in the Instrument/Location
workspace. The download status of each location is recorded in the Download
Monitor. The Requires Download column indicates how many of the total
number of analyzers reporting to a location have exceeded the Download
Criteria. Clicking the location will open the Instrument and Location
workspace where noncompliant analyzers will be highlighted.
The monitors are updated or refreshed according to the schedule selected
during the customization of the CDS. The data can be manually refreshed by
clicking the Refresh toolbar button or by pressing the F5 key.

Rev. Date: 07/12/04 Art: 714384-01C 22-61

 Interface Monitor The Interface Monitor accessed via the menu bar functions with an interface
installed by i-STAT Corporation. To access the the interface monitor for an
interface installed by a third party, click on the Interface Manager button in
the tray at the bottom of the screen.
The Interface Monitor identifies quickly the status of the Interface to an
external computer. The number of pending results is shown as well as any
exceptions in the last 72 hours. Clicking an exception takes you to the Unsent
Results viewer to address the exception.

22-62 Art: 714384-01C Rev. Date: 07/12/04

REPORTS

Overview Reports for managing the point-of-care testing process are available from the
CDS program. Three reports can be generated: Reagent Management, Method
Competency and Method Compliance. These show information summarized
by operator, location, department, or analyzer. Reports can be printed.

Reagent Management This is a report of cartridge usage by Department or Location. Select a date
range for the report. Data in reports, with the exception of “Operator”, can be
sorted by clicking on the column headers. By Operator data is pre-sorted by
department. Select a report by Reagent Usage by Department, Reagent Usage
by Location, Reagent Usage by Operator, or Reagent Usage by Analyzer, and
then select either All Locations or All Departments, or select one Location
or one Department from the drop down menu. Select the desired result types
(Test, Control, Car/Ver, Proficiency) and then click the OK button.

Rev. Date: 07/12/04 Art: 714384-01C 22-63

 Method Compliance This is a report of exceptions of policy and procedure for cartridge testing by
Department, Location or Operator. This information is available when there is
an interface to an external computer.
Select a date range for the report. Select a Report by Department, Location or
Operator, then select All Locations or All Departments or select one Location
or Department from the list. Click on Display operator names if desired.
When Method Compliance by Operator is selected, operators will be listed
by department. Select the filtering criteria for the report and then click the OK
button.

22-64 Art: 714384-01C Rev. Date: 07/12/04

Method Competence This is a report of Quality Check Code occurrence for cartridges by Department,
Operator, Location or Analyzer.
Select a date range for the report. Select a Report by Department, Location,
Operator, or Analyzer and then select All Locations or All Departments or
select one or more Locations or Departments from the list. Click on Display
operator names if desired. Select the filtering criteria for the report. Then
click the OK button.
When Quality Check Codes by Department is selected, operators will be
listed by Department.

Rev. Date: 07/12/04 Art: 714384-01C 22-65

 A legend mapping individual code numbers to their respective quality check
code categories is available for viewing. To access this legend:
1. Create the desired Quality Check Code report.

2. With the report still on the screen, click on Report ➩ View QC

Codes by Category... The following dialog will appear for viewing or
printing.

For details of these Quality Check Codes, see the Technical Bulletin: Analyzer
Coded Messages.

22-66 Art: 714384-01C Rev. Date: 07/12/04

SYSTEM

Customization: Configuration of the CDS can be viewed.

Central Data Station
Settings

Customization: i-STAT Customization profiles of the i-STAT analyzers can be viewed.

Analyzer Settings

AutoSend When enabled, data will be transmitted automatically from the CDS to the
LIS or other information management system when received by the CDS. If
AutoSend is not enabled, results can be sent to the LIS manually. Highlight
the records to be sent in the appropriate Data Viewer Results viewer then
click Record ➩ Send Selected Records. If AutoSend is enabled, it will be
checkmarked under the System option on the menu bar. If an external
interface is not enabled, AutoSend will appear in grey typeface.

Print Option A Printer Dialog box has been added so that when Print is selected from the
menu, the user can choose from a list of installed printers. This allows the
user the option to utilize their own network printer. To access this feature,
you must perform one of the following:

a. Click on Main ➩ Print, or

b. Click on Records ➩ Print Selected Records

Rev. Date: 07/12/04 Art: 714384-01C 22-67

22-68 Art: 714384-01C Rev. Date: 07/12/04
HELP
Technical Support Phone number for your Customer Support Representative.

About… Software version of the Central Data Station.

LANGUAGE SUPPORT
For new CDS Version 5 installations only, the CDS screens are now available in
English, German, Swedish, Italian, and Spanish languages.
During the initial installation or upgrade of the CDS 5 software, all U.S.
customers should choose “English” when the language choice drop down
menu appears. Failure to do so will result in the following consequences:
1. If the wrong language was chosen during the initial installation of the
Version 5 software, all CDS screens will appear in the language chosen.
Contact i-STAT Technical Services if this has occurred.
2. If the wrong language was chosen during an upgrade of the CDS
5 software, the i-STAT installation instructions will appear in the
language chosen, but the CDS screens will remain in English.

Rev. Date: 07/12/04 Art: 714384-01C 22-69

 CARTRIDGE AND TEST INFORMATION

i-STAT sensors are available in a variety of panel configurations. Sensors are contained in cartridges
with microfluidic components and, in some cartridges, calibration solution. i-STAT cartridges are used
with the i-STAT Portable Clinical Analyzer, the i-STAT1 Analyzer* and the Philips Medical Systems
Blood Analysis Module** for the simultaneous quantitative determination of specific analytes and
coagulation parameters in whole blood.
CARTRIDGES SPECIFICATIONS
Shelf Life: Refrigerated at 2 to 8ºC (35 to 46ºF) until expiration date.
Room temperature at 18 to 30ºC (64 to 86ºF) for two weeks.
Preparation for Use: Individual cartridges may be used after standing five minutes at room
temperature. An entire box of cartridges should stand at room temperature for
one hour.
All cartridges should be used immediately after opening
pouch. If the pouch has been punctured, the cartridge
should not be used.

Sample Type: Fresh whole blood from arterial, venous, or skin

punctures
(Note: Skin puncture is NOT a recommended sample type
for ACT or cTnI testing.)
cTnI cartridges require the use of heparinized whole
blood or plasma, or non-heparinized whole blood tested
within one minute of patient draw.

Sample Volume: 16µL, 20µL, 40µL, 65µL, or 95µL depending on cartridge

type.

Test Timing: Immediately after collection

• Samples for the measurement of ACT, PT/INR and Lactate

Within 3 minutes after collection

• Samples collected in capillary tubes, both with and without
anticoagulant
• Samples collected in evacuated or non-evacuated tubes and syringes
without anticoagulant

Within 10 minutes after collection

• Samples collected with anticoagulant for the measurement of pH,
PCO2, PO2 and iCa. Maintain anaerobic conditions. Remix before
filling cartridge.
Within 30 minutes after collection
• Sodium, potassium, chloride, glucose, BUN/urea, creatinine,
hematocrit, troponin I. Remix thoroughly before testing.

* The cTnI cartridge can only be used with the i-STAT 1 analyzer bearing the
symbol.
** Blood Analysis Module supports neither the PT/INR cartridge nor the cTnI
cartridge.

Art: 714258-01F Rev. Date: 01/25/05 CTI Intro. 1

 Analysis Time: • ACT cartridge: to detection of end point - up to 1000 seconds
(16.7 min.)
• PT/INR cartridge: to detection of end point – up to 300 seconds
(5 min.)
• cTnI cartridge: 600 seconds (10 min.)
• Other cartridges: typically 130 to 200 seconds

Collection Options
Cartridges Directly from
Syringes Evacuated Tubes Capillary Tubes
Skin Puncture
Cartridges • Without anticoagulant • Without anticoagulant • Without anticoagulant • Not recommended
which • With balanced heparin • With sodium or lithium • With balanced heparin
measure anticoagulant (syringe heparin anticoagulant anticoagulant
ionized must be filled to labeled (tubes must be filled to
calcium capacity) capacity)
• Without anticoagulant • Without anticoagulant, • Not recommended • Not recommended
ONLY clot activators, or serum
Cartridges • Syringes must be plastic separators ONLY
which • Tubes must be plastic
perform
ACT • Devices used to transfer
sample to cartridge
must be plastic

• Without anticoagulant • Without anticoagulant, • Not recommended • Recommended

ONLY clot activators, or serum
Cartridges separators ONLY
• Syringes must be plastic
which
• Tubes must be plastic
perform
PT/INR • Devices used to transfer
sample to cartridge
must be plastic
• With Sodium or • With Sodium or • Not recommended • Not recommended
lithium heparin lithium heparin
anticoagulant. anticoagulant.
Cartridges • Without anticoagulant • Without anticoagulant
which if tested within one if tested within one
perform minute of patient draw. minute of patient draw.
Troponin I • Samples should not be
used unless the blood
collection tube is filled
at least half full.
• Without anticoagulant • Without anticoagulant • Without anticoagulant • While a sample
• With lithium, sodium, • With lithium or sodium • With balanced heparin can be transferred
or balanced heparin heparin anticoagulant anticoagulant directly from a
All other skin puncture to a
anticoagulant • With sodium or lithium
cartridges cartridge, a capillary
heparin if labeled for
tube is preferred.
the measurement of
electrolytes

Note Regarding System Reliability

The i-STAT System automatically runs a comprehensive set of quality checks of analyzer and cartridge
performance each time a sample is tested. This internal quality system will suppress results if the
analyzer or cartridge does not meet certain internal specifications (see Quality Control section
in System Manual for detailed information). To minimize the probability of delivering a result
with medically significant error the internal specifications are very stringent. It is typical for the

CTI Intro. 2 Art: 714258-01F Rev. Date: 01/25/05

system to suppress a very small percentage of results in normal operation given the stringency of
these specifications. If however the analyzer or cartridges have been compromised, results may
be persistently suppressed, and one or the other must be replaced to restore normal operating
conditions. Where unavailability of results while awaiting replacement of analyzers or cartridges
is unacceptable, i-STAT recommends maintaining both a backup i-STAT System analyzer and
cartridges from an alternate lot number.

EXPECTED VALUES
Measured:

REPORTABLE REFERENCE
TEST UNITS RANGE RANGE
(arterial) (venous)
Sodium/Na mmol/L (mEq/L) 100 – 180 138 – 146 138 – 146
Potassium/K mmol/L (mEq/L) 2.0 – 9.0 3.5 – 4.9 3.5 – 4.9
Chloride/Cl mmol/L (mEq/L) 65 – 140 98 – 109 98 – 109
Glucose/Glu mmol/L 1.1 – 38.9 3.9 – 5.8 3.9 – 5.8
mg/dL 20 – 700 70 – 105 70 – 105
g/L 0.20 – 7.00 0.70 – 1.05 0.70 – 1.05
Lactate/Lac mmol/L 0.30 – 20.00 0.36 – 1.25 0.90 – 1.70
mg/dL 2.7 – 180.2 3.2 – 11.3 8.1 – 15.3
Creatinine/Crea mg/dL 0.2 – 20.0 0.6 – 1.3 0.6 – 1.3
µmol/L 18 – 1768 53 – 115 53 – 115
pH 6.5 – 8.0 7.35 – 7.45 7.31 – 7.41
PCO2 mmHg 5 – 130 35 – 45 41 – 51
kPa 0.67 – 17.33 4.67 – 6.00 5.47 – 6.80
PO2 mmHg 5 – 800 80 – 105
kPa 0.7 – 106.6 10.7 – 14.0
Ionized Calcium/iCa mmol/L 0.25 – 2.50 1.12 – 1.32 1.12 – 1.32
mg/dL 1.0 – 10.0 4.5 – 5.3 4.5 – 5.3
Urea Nitrogen/BUN mg/dL 3 – 140 8 – 26 8 – 26
Urea mmol/L 1 – 50 2.9 – 9.4 2.9 – 9.4
mg/dL 6 – 300 17 – 56 17 – 56
Hematocrit/Hct %PCV 10 – 75 38 – 51 38 – 51
Fraction 0.10 – 0.75 0.38 – 0.51 0.38 – 0.51
Celite Activated seconds 50 – 1000 74 – 125 (Prewrm) 74 – 125 (Prewrm)
Clotting Time / 84 – 139 (Nonwrm) 84 – 139 (Nonwrm)
CeliteACT

The range from 80 - 1000 seconds has been verified through method comparison studies.

Kaolin Activated seconds 50 – 1000 74 – 137 (Prewrm) 74 – 137 (Prewrm)

Clotting Time / 82 – 152 (Nonwrm) 82 – 152 (Nonwrm)
KaolinACT

The range from 77 - 1000 seconds has been verified through method comparison studies.

Prothrombin Time / PT INR 0.9 – 8.0

Performance characteristics have not been established for INRs above 6.0.

Troponin I / cTnI ng/mL (µg/L) 0.00 – 50.00 0.00 – 0.03*

Performance characteristics have not been established for cTnI values above 35.00 ng/mL.
* Represents the 0 to 97.5% range of results.

Rev. Date: 01/25/05 Art: 714258-01F CTI Intro. 3

 Calculated:
REPORTABLE REFERENCE
TEST UNITS RANGE RANGE
(arterial) (venous)
Hemoglobin/Hb g/dL 3.4 – 25.5 12 – 17 12 – 17
g/L 34 – 255 120 – 170 120 – 170
mmol/L 2.1 – 15.8 7 – 11 7 – 11
TCO2 mmol/L (mEq/L) 1 – 85 23 – 27 24 – 29
HCO3 mmol/L (mEq/L) 1.0 – 85.0 22 – 26 23 – 28
BE mmol/L (mEq/L) (-30) – (+30) (-2) – (+3) (-2) – (+3)
Anion Gap/AnGap mmol/L (mEq/L) (-10) – (+99) 10 – 20 10 – 20
sO2 % 0 – 100 95 – 98

CTI Intro. 4 Art: 714258-01F Rev. Date: 01/25/05

CARTRIDGE CONFIGURATIONS AND SAMPLE VOLUME

EC
8+ (65µL) EG
7+ (95µL) CG
8+ (95µL)

Sodium (Na) Sodium (Na) Sodium (Na)

Potassium (K) Potassium (K) Potassium (K)
Chloride (Cl) Ionized Calcium (iCa) Ionized Calcium (iCa)
pH Hematocrit (Hct) Glucose (Glu)
PCO2 pH Hematocrit (Hct)
Urea Nitrogen (BUN)/Urea PCO2 pH
Glucose (Glu) PO2 PCO2
Hematocrit (Hct) TCO2* PO2
TCO2* HCO3* TCO2*
HCO3* BE* HCO3*
BE* sO2* BE*
Anion Gap* (Angap) Hemoglobin* (Hb) sO2*
Hemoglobin* (Hb) Hemoglobin* (Hb)
EG
6+ (95µL)
6 + (65µL)
Sodium (Na) ACT
Celite (40µL)
Sodium (Na) Potassium (K) Celite® ACT
Potassium (K) Hematocrit (Hct)
Chloride (Cl) pH
Urea Nitrogen (BUN)/Urea PCO2
KAOLIN
ACT (40µL)

Glucose (Glu) PO2 Kaolin ACT

Hematocrit (Hct) TCO2*
Hemoglobin* (Hb) HCO3*
BE* PT/INR (20µL)

sO2* Prothrombin Time

EC
4+ (65µL)
Hemoglobin* (Hb)
Sodium (Na)
CTnI (16 µL)
Potassium (K) G
3+ (95µL)
Glucose (Glu) Troponin I
Hematocrit (Hct) pH
Hemoglobin* (Hb) PCO2 CK-MB (16µL)**
PO2
TCO2* Creatine Kinase MB Isoenzyme
E
3+ (65µL)
HCO3*
Sodium (Na) BE* BNP (16µL)**
Potassium (K) sO2*
B-type Natriuretic Peptide
Hematocrit (Hct)
Hemoglobin* (Hb)
CG
4+ (95µL)
CHEM8+ (65µL)**
pH
G (65µL)
PCO2 Sodium (Na)
PO2 Potassium (K)
Glucose (Glu) Chloride (Cl)
Lactate
TCO2* Urea Nitrogen (BUN)/Urea
CREA (65µL) HCO3* Glucose (Glu)
BE* Creatinine (Crea)
Creatinine (Crea) Ionized Calcium (iCa)
sO2*
TCO2
Hematocrit (Hct)
Anion Gap* (Angap)
Hemoglobin* (Hb)

*Calculated Celite is a registered trademark of

Celite Corporation, Santa Barbara,
**(release date to be determined)
CA, for its diatomaceous earth
products.

Rev. Date: 01/25/05 Art: 714258-01F CTI Info. 5

 SODIUM/NA

Sodium is measured by ion-selective electrode potentiometry. In the calculation of results for sodium,
concentration is related to potential through the Nernst equation.
The i-STAT System uses direct (undiluted) electrochemical methods. Values obtained by direct methods
may differ from those obtained by indirect (diluted) methods.1
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.2
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for sodium, as part of the i-STAT System, is intended for use in the in vitro quantification of
sodium in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives. For cartridges
that contain a sensor for the measurement of sodium, a list of reactive ingredients is indicated below:

Reactive Ingredient
Sodium (Na+)

Metrological Traceability
The i-STAT System test for sodium measures sodium amount-of-substance concentration in the plasma
fraction of arterial, venous, or capillary whole blood (dimension mmol L-1) for in vitro diagnostic
use. Sodium values assigned to i-STAT’s controls and calibration verification materials are traceable to
the U.S. National Institute of Standards and Technology (NIST) standard reference material SRM956.
i-STAT System controls and calibration verification materials are validated for use only with the i-
STAT System and assigned values may not be commutable with other methods. Further information
regarding metrological traceability is available from i-STAT Corporation.

Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range3
Sodium/Na mmol/L (mEq/L) 100–180 138 – 146

*The i-STAT System can be configured with the preferred units.

The i-STAT reference range for whole blood listed above is similar to reference ranges derived from
serum or plasma measurements with standard laboratory methods.
The reference range programmed into the analyzer and shown above is intended to be used as a guide
for the interpretation of results. Since reference ranges may vary with demographic factors such as
age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Art: 714173-01F Rev. Date: 01/25/05

 Clinical Significance
Tests for sodium in the blood are important in the diagnosis and treatment of patients suffering
from hypertension, renal failure or impairment, cardiac distress, disorientation, dehydration, nausea
and diarrhea. Some causes of increased values for sodium include dehydration, diabetes insipidus,
salt poisoning, skin losses, hyperaldosteronism and CNS disorders. Some causes for decreased values
for sodium include dilutional hyponatremia (cirrhosis), depletional hyponatremia and syndrome of
inappropriate ADH.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A4. Venous blood samples were
collected in lithium heparin Vacutainer® tubes and analyzed in duplicate on the i-STAT System. A
portion of the specimen was centrifuged and the separated plasma was analyzed in duplicate on
comparative methods within 20 minutes of collection.
Deming regression analysis5 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
Interference studies were based on NCCLS guideline EP7.6
*The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.4 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (mmol/L or mEq/L)

Aqueous Control Mean SD %CV
Level 1 120.0 0.46 0.4
Level 3 160.0 0.53 0.3

Method Comparison (mmol/L or mEq/L)

Beckman Nova
Synchron Kodak STAT
CX 3
® Ektachem™ 700 Profile® 5
n 189 142 192
Sxx 0.74 0.52 0.54
Syy 0.53 0.58 0.53
Slope 1.00 0.98 0.95
Int’t -0.11 3.57 5.26
Sy.x 1.17 1.04 1.53
Xmin 126 120 124
Xmax 148 148 148
r 0.865 0.937 0.838

SODIUM Art: 714173-01F Rev. Date: 01/25/05

Cartridge Comparison
The performance characteristics of the sensors are equivalent in all cartridge configurations. System
difference analysis was performed on 40 patient samples using the i-STAT 6+ and i-STAT EC4+
cartridges. In the 130–150 mmol/L range the average difference was 0.750.

Factors Affecting Results*

Sodium heparin may increase sodium results up to 1mmol/L.
Hemodilution of the plasma by more than 20% associated with priming cardiopulmonary bypass
pumps, plasma volume expansion or other fluid administration therapies using certain solutions may
cause clinically significant error on sodium, chloride, ionized calcium and pH results. These errors
are associated with solutions that do not match the ionic characteristics of plasma. To avoid these
errors when hemodiluting by more than 20%, use physiologically balanced multi-electrolyte solutions
containing low-mobility anions (e.g. gluconate) such as Normosol®-R (Abbott Laboratories), Plasma-
Lyte®-A (Baxter Healthcare Corporation), and Isolyte®-S (B Braun Medical) rather than solutions such
as normal saline or Ringer’s Lactate.

Interferent Effect
β-hydroxybutyrate 16 mmol/L (166 mg/dL) β-hydroxybutyrate will decrease sodium results by
5 mmol/L.

Bromide 37.5 mmol/L bromide will increase sodium results by 5 mmol/L.

Lactate 20 mmol/L lactate will decrease sodium results by 5 mmol/L.

*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

References
1. N.W. Tietz, E.L. Pruden, O. Siggaard-Andersen, “Electrolytes “ in Tietz Textbook of Clinical
Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders Company,
1994).
2. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
3. B.E. Statland, Clinical Decision Levels for Lab Tests (Oradell, NJ: Medical Economic Books, 1987).
4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA 1995.
5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P [ISBN 1-
56238-020-6]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1986.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and
Company, Franklin Lakes, NJ USA. CX®3 is a registered trademark of Beckman Coulter Incorporated, Fullerton CA USA. Ektachem was a
trademark of Kodak Clinical Diagnostics. This system is now the Vitros®distributed by Ortho-Clinical Diagnostics, Rochester, NY USA. Stat
Profile is a registered trademark of Nova Biomedical, Waltham, MA USA. Normosol is a trademark of Abbott Laboratories, Abbott Park, IL, USA.
Plasma-Lyte is a registered trademark of Baxter International Inc., Deerfield, IL, USA. Isolyte is a trademark of B. Braun Medical Inc., Germany.

Rev. Date: 01/25/05 Art: 714173-01F SODIUM

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714173-01F Rev. Date: 01/25/05

 POTASSIUM/K

Potassium is measured by ion-selective electrode potentiometry. In the calculation of results for

potassium, concentration is related to potential through the Nernst equation.
The i-STAT System uses direct (undiluted) electrochemical methods. Values obtained by direct methods
may differ from those obtained by indirect (diluted) methods.1
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.2
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for potassium, as part of the i-STAT System, is intended for use in the in vitro quantification of
potassium in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives. For cartridges that
contain a sensor for the measurement of potassium, a list of reactive ingredients is indicated below:

Reactive Ingredient
Potassium (K+)

Metrological Traceability
The i-STAT System test for potassium measures potassium amount-of-substance concentration in
the plasma fraction of arterial, venous, or capillary whole blood (dimension mmol L-1) for in vitro
diagnostic use. Potassium values assigned to i-STAT’s controls and calibration verification materials
are traceable to the U.S. National Institute of Standards and Technology (NIST) standard reference
material SRM956. i-STAT System controls and calibration verification materials are validated for use
only with the i-STAT System and assigned values may not be commutable with other methods. Further
information regarding metrological traceability is available from i-STAT Corporation.

Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range3
Potassium/K mmol/L(mEq/L) 2–9 3.5 – 4.9**
*The i-STAT System can be configured with the preferred units.

**The reference range for potassium listed above has been reduced by 0.2mmol/L from the range cited in Reference 3 to account for the
difference between serum and plasma results.

The i-STAT reference range for whole blood listed above is similar to reference ranges derived from
serum or plasma measurements with standard laboratory methods.
The reference range programmed into the analyzer and shown above is intended to be used as a
guide for the interpretation of results. Since reference ranges may vary with demographic factors such
as age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Art: 714174-01E Rev. Date: 01/25/05

 Clinical Significance
Tests for potassium in the blood are important in the diagnosis and treatment of patients suffering
from hypertension, renal failure or impairment, cardiac distress, disorientation, dehydration, nausea
and diarrhea. Some causes of increased values for potassium include renal glomerular disease,
adrenocortical insufficiency, diabetic ketacidosis (DKA), sepsis and in vitro hemolysis. Some causes of
decreased values for potassium include renal tubular disease, hyperaldosteronism, treatment of DKA,
hyperinsulinism, metabolic alkalosis and diuretic therapy.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A4. Venous blood samples were
collected in lithium heparin Vacutainer® tubes and analyzed in duplicate on the i-STAT System. A
portion of the specimen was centrifuged and the separated plasma was analyzed in duplicate on
comparative methods within 20 minutes of collection.
Deming regression analysis5 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
Interference studies were based on NCCLS guideline EP7.6
*The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.4 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (mmol/L or mEq/L)

Aqueous Control Mean SD %CV
Level 1 2.85 0.038 1.3
Level 3 6.30 0.039 0.6

Method Comparison (mmol/L or mEq/L)

Beckman Nova
Synchron Kodak STAT
CX®3 Ektachem™ 700 Profile® 5
n 189 142 192
Sxx 0.060 0.031 0.065
Syy 0.055 0.059 0.055
Slope 0.97 1.06 0.99
Int't 0.02 -0.15 -0.01
Sy.x 0.076 0.060 0.112
Xmin 2.8 3.0 2.8
Xmax 5.7 9.2 5.8
r 0.978 0.993 0.948

POTASSIUM Art: 714174-01E Rev. Date: 01/25/05

Cartridge Comparison
The performance characteristics of the sensors are equivalent in all cartridge configurations. System
difference analysis was performed on 40 patient samples using the i-STAT 6+ and i-STAT EC4+
cartridges. In the 3.0–5.0 mmol/L range the average difference was 0.049.

Factors Affecting Results*

If heparinized whole blood is allowed to stand before testing, potassium values will first decrease
slightly, then increase over time. Potassium values will increase in iced specimens.
Potassium values from anticoagulated samples are preferred to serum values because 0.1 to 0.7 mmol/L
potassium can be released from platelets1 and red blood cells during the clotting process. Potassium
values obtained from skin puncture samples may vary due to hemolysis or an increase in tissue fluid
from improper technique during the collection procedure.
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

References
1. N.W. Tietz, E.L. Pruden, O. Siggaard-Andersen, ”Electrolytes ” in Tietz Textbook of Clinical
Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders
Company, 1994).
2. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
3. B.E. Statland, Clinical Decision Levels for Lab Tests (Oradell, NJ: Medical Economic Books, 1987).
4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA 1995.
5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P [ISBN
1-56238-020-6]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1986.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and
Company, Franklin Lakes, NJ USA. CX 3 is a registered trademark of Beckman Coulter Incorporated, Fullerton, CA USA. Ektachem was a
trademark of Kodak Clinical Diagnostics. This system is now the Vitros distributed by Ortho-Clinical Diagnostics, Rochester, NY USA. Stat
Profile is a registered trademark of Nova Biomedical, Waltham, MA USA.

Rev. Date: 01/25/05 Art: 714174-01E POTASSIUM

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. Alle rettigheder forbeholdes. Trykt i USA.

Art: 714174-01E Rev. Date: 01/25/05

 CHLORIDE/CL

Chloride is measured by ion-selective electrode potentiometry. In the calculation of results for chloride,
concentration is related to potential through the Nernst equation.
The i-STAT System uses direct (undiluted) electrochemical methods. Values obtained by direct methods
may differ from those obtained by indirect (diluted) methods.1
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.2
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for chloride, as part of the i-STAT System, is intended for use in the in vitro quantification of
chloride in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives. For cartridges that
contain a sensor for the measurement of chloride, a list of reactive ingredients is indicated below:

Reactive Ingredient
Chloride (Cl-)

Metrological Traceability
The i-STAT System test for chloride measures chloride amount-of-substance concentration in the
plasma fraction of arterial, venous, or capillary whole blood (dimension mmol L -1) for in vitro
diagnostic use. Chloride values assigned to i-STAT’s controls and calibration verification materials
are traceable to the U.S. National Institute of Standards and Technology (NIST) standard reference
material SRM956. i-STAT System controls and calibration verification materials are validated for use
only with the i-STAT System and assigned values may not be commutable with other methods. Further
information regarding metrological traceability is available from i-STAT Corporation.

Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range3
Chloride/CL mmol/L(mEq/L) 65 – 140 98 – 109

*The i-STAT System can be configured with the preferred units.

The i-STAT reference range for whole blood listed above is similar to reference ranges derived from
serum or plasma measurements with standard laboratory methods.
The reference range programmed into the analyzer and shown above is intended to be used as a
guide for the interpretation of results. Since reference ranges may vary with demographic factors such
as age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Art: 714175-01F Rev. Date: 01/25/05

 Clinical Significance
Tests for chloride in the blood are important in the diagnosis and treatment of patients suffering
from hypertension, renal failure or impairment, cardiac distress, disorientation, dehydration, nausea
and diarrhea. Some causes of increased values for chloride include prolonged diarrhea, renal tubular
disease, hyperparathyroidism and dehydration. Some causes for decreased values for chloride include
prolonged vomiting, burns, salt-losing renal disease, overhydration and thiazide therapy.

Performance Characteristics
The performance characteristics of the sensors are equivalent in all cartridge configurations.
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A4. Venous blood samples were
collected in lithium heparin Vacutainer® tubes and analyzed in duplicate on the i-STAT System. A
portion of the specimen was centrifuged and the separated plasma was analyzed in duplicate on
comparative methods within 20 minutes of collection.
Deming regression analysis5 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
Interference studies were based on NCCLS guideline EP7.6
* The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over a nar-
row range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these estimates
may be invalid”.4 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in overcoming this
problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (mmol/L or mEq/L)

Aqueous Control Mean SD %CV
Level 1 76.7 0.54 0.7
Level 3 114.0 0.56 0.5

Method Comparison (mmol/L or mEq/L)

Beckman Synchron CX®3 Kodak Ektachem™ 700 Nova STAT Profile® 5
n 189 142 192
Sxx 1.27 0.41 0.89
Syy 0.88 0.90 0.88
Slope 0.99 0.88 0.93
Int’t -0.82 14.6 4.3
Sy.x 1.65 1.84 2.33
Xmin 93 63 96
Xmax 114 128 117
r 0.817 0.914 0.752

CHLORIDE Art: 714175-01F Rev. Date: 01/25/05

Factors Affecting Results*
Hemodilution of the plasma by more than 20% associated with priming cardiopulmonary bypass
pumps, plasma volume expansion or other fluid administration therapies using certain solutions may
cause clinically significant error on sodium, chloride, ionized calcium and pH results. These errors
are associated with solutions that do not match the ionic characteristics of plasma. To avoid these
errors when hemodiluting by more than 20%, use physiologically balanced multi-electrolyte solutions
containing low-mobility anions (e.g. gluconate) such as Normosol®-R (Abbott Laboratories), Plasma-
Lyte®-A (Baxter Healthcare Corporation), and Isolyte®-S (B Braun Medical) rather than solutions such
as normal saline or Ringer’s Lactate.
Interferent Effect
ß-hydroxybutyrate 16 mmol/L (166 mg/dL) b-hydroxybutyrate will increase chloride results by 3 mmol/L.
Bromide 12.5 mmol/L (100 mg/dL) bromide will increase chloride results by 30 mmol/L.
Lactate 11 mmol/L (100 mg/dL) lactate will increase chloride results by 3.5 mmol/L.
Salicylate 4 mmol/L salicylate will increase chloride results by 5 mmol/L
Thiocyanate Thiocyanate may cause falsely elevated chloride results, or may cause chloride
results to be suppressed (“star out”).
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due to
test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

References
1. N.W. Tietz, E.L. Pruden, O. Siggaard-Andersen, ”Electrolytes ” in Tietz Textbook of Clinical
Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders Company,
1994).
2. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
3. B.E. Statland, Clinical Decision Levels for Lab Tests (Oradell, NJ: Medical Economic Books, 1987).
4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA 1995.
5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P [ISBN 1-
56238-020-6]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1986.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and Com-
pany, Franklin Lakes, NJ USA. CX®3 is a registered trademark of Beckman Coulter Incorporated, Fullerton CA USA. Ektachem was a trademark of
Kodak Clinical Diagnostics. This system is now the Vitros®distributed by Ortho-Clinical Diagnostics, Rochester, NY USA. Stat Profile is a registered
trademark of Nova Biomedical, Waltham, MA USA. Normosol is a trademark of Abbott Laboratories, Abbott Park, IL, USA. Plasma-Lyte is a regis-
tered trademark of Baxter International Inc., Deerfield, IL, USA. Isolyte is a trademark of B. Braun Medical Inc., Germany.

Rev. Date: 01/25/05 Art: 714175-01F CHLORIDE

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714175-01F Rev. Date: 01/25/05

 BUN/UREA

Urea is hydrolyzed to ammonium ions in a reaction catalyzed by the enzyme urease.

urease
Urea + H2O + 2H+ 2NH+4 + CO2
The ammonium ions are measured potentiometrically by an ion-selective electrode. In the calculation
of results for urea, concentration is related to potential through the Nernst Equation.
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.1
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for blood urea nitrogen (BUN/urea), as part of the i-STAT System, is intended for use in the in vitro
quantification of BUN/urea in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives. For cartridges
that contain a sensor for the measurement of urea nitrogen, a list of reactive ingredients is indicated
below:

Reactive Ingredient Biological Source

Urea N/A
Urease Canavalia ensiformis

Metrological Traceability
The i-STAT System test for blood urea nitrogen/urea measures blood urea nitrogen/urea amount-of-
substance concentration in the plasma fraction of arterial, venous, or capillary whole blood (dimension
mmol L-1) for in vitro diagnostic use. BUN/urea values assigned to i-STAT’s controls and calibration
verification materials are traceable to the U.S. National Institute of Standards and Technology (NIST)
standard reference material SRM909. i-STAT System controls and calibration verification materials are
validated for use only with the i-STAT System and assigned values may not be commutable with other
methods. Further information regarding metrological traceability is available from i-STAT Corporation

Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range2
Urea Nitrogen/BUN mg/dL 3 – 140 8 – 26
Urea mmol/L 1 – 50 2.9 – 9.4
Urea mg/dL 6 – 300 17 - 56

*The i-STAT System can be configured with the preferred units.

To convert a BUN result in mg/dL to a urea result in mmol/L, multiply the BUN result by 0.357. To
convert a urea result in mmol/L to a urea result in mg/dL, multiply the mmol/L result by 6.

Art: 714176-01E Rev. Date: 01/25/05

 The i-STAT reference ranges for whole blood listed above are similar to reference ranges derived from
serum or plasma measurements with standard laboratory methods.
The reference range programmed into the analyzer and shown above is intended to be used as a guide
for the interpretation of results. Since reference ranges may vary with demographic factors such as
age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Clinical Significance
An abnormally high level of urea nitrogen in the blood is an indication of kidney function
impairment or failure. Some other causes of increased values for urea nitrogen include prerenal
azotemia (e.g. shock), postrenal azotemia, GI bleeding and a high protein diet. Some causes of
decreased values for urea nitrogen include pregnancy, severe liver insufficiency, overhydration
and malnutrition.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A3. Venous blood samples were
collected in lithium heparin Vacutainer® tubes and analyzed in duplicate on the i-STAT System. A
portion of the specimen was centrifuged and the separated plasma was analyzed in duplicate on
comparative methods within 20 minutes of collection.
Deming regression analysis4 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
Interference studies were based on NCCLS guideline EP7.5
*The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.3 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (mg/dL)

Aqueous Control Mean SD %CV
Level 1 52.8 0.76 1.4
Level 3 5.5 0.45 8.2

BUN/UREA Art: 714176-01E Rev. Date: 01/25/05

Method Comparison (mg/dL)

Beckman Coulter Dade Dimension Beckman Coulter

LX20 RxL-Xpand CX9
n 39 32 26
Sxx 0.36 0.48 0.39
Syy 0.67 0.34 0.60
Slope 1.03 1.05 1.00
Int’t 1.39 -0.28 -0.38
Sy.x 0.99 0.31 0.85
Xmin 5 5 7
Xmax 70 38 66
r 0.997 0.998 0.997

Cartridge Comparison
The performance characteristics of the sensors are equivalent in all cartridge configurations. System
difference analysis was performed on 40 patient samples using the i-STAT 6+ and i-STAT EC8+
cartridges. In the 25–60 mg/dL range the average difference was -1.13. In the 60–140 mg/dL range the
average difference was -0.77.

Factors Affecting Results*

Endogenous ammonium ions will not affect results.
Interferent Effect
Thiocyanate Thiocyanate can cause falsely decreased BUN/urea results on the i-STAT
System. Preliminary studies indicated that 140 mg/dL (24 mmol/L)
thiocyanate decreased BUN/urea results from 11.8 to 9.3 mg/dL
(4.2 to 3.3 mmol/L), approximately 21%. Thiocyanate is a degradation
product of nitroprusside treatment and also a product of thiosulphate
treatment of cyanide poisoning.
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Rev. Date: 01/25/05 Art: 714176-01E BUN/UREA

References
1. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American Association
of Clinical Chemistry, 1990).
2. B.E. Statland, Clinical Decision Levels for Lab Tests (Oradell, NJ: Medical Economic Books, 1987).
3. NCCLS. Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Guideline.
NCCLS document H7-A3 [ISBN 1-56238-413-9]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2001.
4. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. D.S. Young and E.W. Bermes, “Influence of Site Collection on Blood Gases and pH,” in
Tietz Textbook of Clinical Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds.
(Philadelphia:W.B. Saunders Company, 1994).

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and
Company, Franklin Lakes, NJ USA. LX20 and CX9 are registered trademarks of Beckman Coulter Incorporated, Fullerton, CA USA. Dimension
RxL-Xpand is a registered trademark of Dade Behring Inc., Deerfield, IL USA.

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714176-01E Rev. Date: 01/25/05

 GLUCOSE/GLU

Glucose is measured amperometrically. Oxidation of glucose, catalyzed by the enzyme glucose oxidase, produces
hydrogen peroxide (H2O2). The liberated hydrogen peroxide is oxidized at the electrode to produce a current
which is proportional to the sample glucose concentration.

glucose oxidase
β-D-glucose + H2O + O2 D-gluconic acid + H2O2

H2O2 2H+ + O2 + 2e-

See below for information on factors affecting results. Certain substances, such as drugs, may affect analyte levels
in vivo.1

If results appear inconsistent with the clinical assessment, the patient sample should be retested using another
cartridge.

Intended Use
The test for glucose, as part of the i-STAT System, is intended for use in the in vitro quantification of glucose in
arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in the cartridge
configuration), sensors for the measurement of specific analytes, and a buffered aqueous calibrant solution
that contains known concentrations of analytes and preservatives. For cartridges that contain a sensor for the
measurement of glucose, a list of reactive ingredients is indicated below:

Reactive Ingredient Biological Source

Glucose N/A
Glucose Oxidase Aspergillus niger

Metrological Traceability
The i-STAT System test for glucose measures glucose amount-of-substance concentration in the plasma fraction of
arterial, venous, or capillary whole blood (dimension mmol L-1) for in vitro diagnostic use. Glucose values assigned
to i-STAT’s controls and calibration verification materials are traceable to the U.S. National Institute of Standards
and Technology (NIST) standard reference material SRM965. i-STAT System controls and calibration verification
materials are validated for use only with the i-STAT System and assigned values may not be commutable with other
methods. Further information regarding metrological traceability is available from i-STAT Corporation.

Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range2
Glucose/Glu mg/dL 20 – 700 70 – 105
(fasting) mmol/L 1.1 – 38.9 3.9 – 5.8
g/L 0.20 – 7.00 0.70 – 1.05

*The i-STAT System can be configured with the preferred units.

To convert a result from mg/dL to mmol/L, multiply the mg/dL value by 0.055.

Art: 714177-01E Rev. Date: 01/25/05

 The i-STAT reference ranges for whole blood listed above are similar to reference ranges derived from serum or
plasma measurements with standard laboratory methods.

The reference range programmed into the analyzer and shown above is intended to be used as
a guide for the interpretation of results. Since reference ranges may vary with demographic factors such
as age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Clinical Significance
Glucose is a primary energy source for the body and the only source of nutrients for brain tissue. Measurements
for determination of blood glucose levels are important in the diagnosis and treatment of patients suffering from
diabetes and hypoglycemia. Some causes for increased values of glucose include diabetes mellitus, pancreatitis,
endocrine disorders (e.g. Cushing’s syndrome), drugs (e.g. steroids, thyrotoxicosis), chronic renal failure, stress, or
I.V. glucose infusion. Some causes of decreased values of glucose include insulinoma, adrenocortical insufficiency,
hypopituitarism, massive liver disease, ethanol ingestion, reactive hypoglycemia, and glycogen storage disease.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care professionals
trained in the use of the i-STAT System and comparative methods.

Precision data were collected at multiple sites as follows: Duplicates of each control fluid were tested in the
morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are presented below.

Method comparison data were collected using NCCLS guideline EP9-A3. Venous blood samples were collected in
lithium heparin Vacutainer® tubes and analyzed in duplicate on the i-STAT System. A portion of the specimen was
centrifuged and the separated plasma was analyzed in duplicate on comparative methods within 20 minutes of
collection.

Deming regression analysis4 was performed on the first replicate of each sample. In the method comparison table,
n is the number of specimens in the data set, Sxx and Syy refer to estimates of imprecision based on the duplicates
of the comparative and the i-STAT methods respectively, Sy.x is the standard error of the estimate, and r is the
correlation coefficient.*

Method comparisons will vary from site to site due to differences in sample handling, comparative method
calibration and other site specific variables.

Interference studies were based on NCCLS guideline EP7.5

* The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.3 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (mg/dL)

Aqueous Control Mean SD %CV

Level 1 41.8 0.68 1.6

Level 3 289 2.4 0.8

GLUCOSE Art: 714177-01E Rev. Date: 01/25/05

Method Comparison (mg/dL)
Beckman Coulter Bayer 860 Dade Dimension
LX20 RxL-Xpand
n 35 40 32
Sxx 2.21 4.71 0.98
Syy 0.69 0.96 0.59
Slope 1.03 0.99 1.01
Int’t -3.39 -1.67 -0.85
Sy.x 0.91 0.70 1.57
Xmin 45 58 48
Xmax 297 167 257
r 0.999 0.993 0.998

Cartridge Comparison
System difference analysis was performed on 40 patient samples using the i-STAT 6+ and i-STAT EC4+ cartridges. In
the 100–200 mg/dL range the average difference was 1.77. In the 200–300 mg/dL range the average difference was
3.7.

Factors Affecting Results*

Glucose values will decrease in whole blood samples over time. Venous blood glucose is as much as
7 mg/dL less than capillary blood glucose as a result of tissue utilization.6

Interferent Effect
Bromide 37.5mmol/L (300mg/dL) bromide will decrease glucose results by 30 mg/dL.

pH Values below 7.4 at 37°C decrease results by approximately 0.9 mg/dL (0.05 mmol/L) per 0.1
pH units. Values above 7.4 at 37°C increase results by approximately 0.8 mg/dL (0.04 mmol/L)
per 0.1 pH units.

Hydroxyurea Hydroxyurea may cause significant errors in the measurement of glucose with the i-STAT
(Droxia®, Hydrea®) System. Use an alternative method to measure glucose when patients have been administered
hydroxyurea. See note (1) below for typical uses of this drug and note (2) below for details of the
interference.

Thiocyanate Thiocyanate can cause falsely low glucose results on the i-STAT System. Preliminary studies
indicated that 24 mmol/L (140 mg/dL) thiocyanate decreased glucose results from 85.6 to 65.8
mg/dL (4.75 to 3.65 mmol/L), approximately 23%. Thiocyanate is a degradation product of
nitroprusside treatment and also a product of thiosulphate treatment of cyanide poisoning.

PO2 Oxygen levels of less than 20 mmHg (2.66 kPa) at 37°C may decrease results.

*It is possible that other interfering substance may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Notes:

1) Hydroxyurea is a DNA synthesis inhibitor used in the treatment of various forms of cancer, sickle cell
anemia, and HIV infection. This drug is used to treat malignancies including melanoma, metastatic
ovarian cancer, and chronic myelogenous leukemia. It is also used in the treatment of polycythemia
vera, thrombocytopenia, and psoriasis. At typical doses ranging from 500 mg to 2 g/day, concentrations
of hydroxyurea in patients’ blood may be sustained at approximately 100 to 500 µmol/L. Higher
concentrations may be observed soon after dosing or at higher therapeutic doses.

Rev. Date: 01/25/05 Art: 714177-01E GLUCOSE

2) For every 100 µmol/L hydroxyurea in the whole blood sample, glucose will be increased by approximately
8 mg/dL (0.44 mmol/L), up to a whole blood hydroxyurea concentration of at least 921 µmol/L (maximum
concentration tested). The magnitude of the bias is independent of the glucose level over a range of at least 75
mg/dL (4.2 mmol/L) to 645 mg/dL (35.8 mmol/L).

Ascorbic acid up to 0.63 mmol/L (11 mg/dL), uric acid up to 12 mg/dL, lactate up to 20 mmol/L (182 mg/dL), β-
hydroxybutyrate up to 20 mmol/L (208 mg/dL), acetoacetate up to 10 mmol/L (100 mg/dL), acetaminophen up to
1.32 mmol/L (20 mg/dL), maltose up to 13.3 mmol/L (480 mg/dL) and hematocrit levels between 15–75 %PCV were
tested and found not to interfere with glucose results.

References
1. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American Association of
Clinical Chemistry, 1990).

2. P.C. Painter, J.Y. Cope, J.L. Smith, “Reference Ranges, Table 41-20” in Tietz Textbook of
Clinical Chemistr y—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B.
Saunders Company, 1994).

3. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document EP9-
A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1995.

4. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-Comparison

Analysis,” Clinical Chemistry 25:3, 432 (1979).

5. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P
[ISBN 1-56238-020-6]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-
1898, USA 1986.

6. D.S. Young and E.W. Bermes, “Influence of Site Collection on Blood Gases and pH,” in Tietz
Te x t b o o k o f C l i n i c a l C h e m i s t r y — S e c o n d E d i t i o n , C . A . B u r t i s a n d E . R . A s h w o o d , e d s .
(Philadelphia:W.B. Saunders Company, 1994).

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and
Company, Franklin Lakes, NJ USA. LX20 is a registered trademark of Beckman Coulter Incorporated, Fullerton, CA USA. The Bayer 860 analyzer
is manufactured by Bayer Diagnostics, Tarrytown, NY USA. Dimension RxL-Xpand is a registered trademark of Dade Behring Inc., Deerfield, IL
USA.

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714177-01E Rev. Date: 01/25/05

 HEMATOCRIT/HCT AND
CALCULATED HEMOGLOBIN/HB

Hematocrit is determined conductometrically. The measured conductivity, after correction for

electrolyte concentration, is inversely related to the hematocrit.
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.1
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for hematocrit, as part of the i-STAT System, is intended for use in the in vitro quantification of
packed red blood cell volume fraction in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous
calibrant solution of known conductance that contains known concentrations of analytes and
preservatives.

Metrological Traceability
The i-STAT System test for hematocrit measures packed red blood cell volume fraction in arterial,
venous, or capillary whole blood (expressed as the % packed cell volume) for in vitro diagnostic use.
Hematocrit values assigned to i-STAT’s working calibrators are traceable to the U.S. National Committee
for Clinical Laboratory Standards (NCCLS) H7-A3 procedure for determining packed cell volume by the
microhematocrit method2. Further information regarding metrological traceability is available from
i-STAT Corporation.

Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range3
Hematocrit/Hct %PCV 10 – 75 38 – 51**
Fraction 0.10 – 0.75 0.38 – 0.51
Hemoglobin/Hb g/dL 3.4 – 25.5 12 – 17
g/L 34 – 255 120 – 170
mmol/L 2.1 – 15.8 7 – 11
* The i-STAT System can be configured with the preferred units.
**The reference ranges for hematocrit and hemoglobin span both female and male populations.

To convert a result from %PCV to fraction packed cell volume, divide the %PCV result by 100. For the
measurement of hematocrit, the i-STAT System can be customized to agree with methods calibrated
by the microhematocrit reference method using either K3EDTA or K2EDTA anticoagulant. Mean cell
volumes of K3EDTA anticoagulated blood are approximately 2-4% less than K2EDTA anticoagulated
blood.2 While the choice of anticoagulant affects the microhematocrit method to which all hematocrit
methods are calibrated, results from routine samples on hematology analyzers are independent of the
anticoagulant used. Since most clinical hematology analyzers are calibrated by the microhematocrit
method using K3EDTA anticoagulant, the i-STAT System default customization is K3EDTA.

Art: 714178-01F Rev. Date: 02/28/05

 The reference range programmed into the analyzer and shown above is intended to be used as a guide
for the interpretation of results. Since reference ranges may vary with demographic factors such as
age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Clinical Significance
Hematocrit is a measurement of the fractional volume of red blood cells. This is a key indicator of the
body’s state of hydration, anemia or severe blood loss, as well as the blood’s ability to transport oxygen.
A decreased hematocrit can be due to either overhydration, which increases the plasma volume, or a
decrease in the number of red blood cells caused by anemias or blood loss. An increased hematocrit can
be due to loss of fluids, such as in dehydration, diuretic therapy, and burns, or an increase in red blood
cells, such as in cardiovascular and renal disorders, polycythemia vera, and impaired ventilation.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A 4. Venous blood samples,
collected in lithium heparin Vacutainer® tubes, were analyzed in duplicate on the i-STAT System and
on the comparative methods for hematocrit within 20 minutes of collection.
Deming regression analysis5 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
Interference studies were based on NCCLS guideline EP7-P.6
*The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.5 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (%PCV)

Whole Blood Control Mean SD %CV
Low 30.0 0.44 1.5
High 49.0 0.50 1.0

HEMATOCRIT Art: 714178-01F Rev. Date: 02/28/05

Method Comparison (%PCV)
Coulter® S Plus Nova STAT Abbott Sysmex SE9500
Profile® 5 Cell-Dyn 4000
n 142 192 29 29
Sxx 0.50 0.46 0.41 0.53
Syy 1.09 1.31 0.77 0.76
Slope 0.98 1.06 1.06 1.11
Int’t 1.78 -3.98 -1.42 -4.19
Sy.x 2.03 2.063 1.13 0.98
Xmin 18 21 19 24
Xmax 51 50 46 47
r 0.952 0.932 0.993 0.980

Factors Affecting Results*

Interferent Effect
WBC Grossly elevated white blood cell counts may increase results.
Total Protein Hematocrit results are affected by the level of total protein as follows:

Displayed Result TP < 6.5 g/dL TP > 8.0 g/dL

HCT < 40 %PCV Hct decreased by ~1% PCV Hct increased by ~1% PCV
for each decrease of for each increase
1 g/dL TP 1 g/dL TP

HCT > 40 % PCV Hct decreased by ~0.75 % PCV Hct increased by ~0.75 %PCV
for each decrease of for each increase
1 g/dL TP 1 g/dL TP

Total protein levels may be low in neonatal and burn patient populations, as
well as in additional clinical populations listed in Statland3. Total protein levels
may also be decreased in patients undergoing cardiopulmonary bypass (CPB)
or ECMO, and with patients receiving large volumes of saline-based IV fluids.
Care should be taken when using hematocrit results from patients with total
protein levels below the adult reference range (6.5 to 8 g/dL).
The CPB sample type can be used to correct the hematocrit result for the
dilutional affect of the pump prime in cardiovascular surgery. The CPB
algorithm assumes that cells and plasma are diluted equally and that the pump
priming solution has no added albumin or other colloid or packed red blood
cells. Since perfusion practices vary, it is recommended that each practice
verify the use of the CPB sample type and the length of time in which the
CPB sample type should be used during the recovery period. Note that for
hematocrit values above 30 %PCV, the CPB correction is ≤1.5 %PCV; the size of
the correction at this level should not impact transfusion decisions.
Lipids Abnormally high lipids may increase results. Interference from lipids will be
about two thirds the size of the interference from protein.
Sodium The sample electrolyte concentration is used to correct the measured
conductivity prior to reporting hematocrit results. Factors that affect sodium
will therefore also affect hematocrit.
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Rev. Date: 02/28/05 Art: 714178-01F HEMATOCRIT

 Sample Collection and Handling
Erroneous hematocrit results can be obtained by improper sample handling.
■ Hematocrit results can be affected by the settling of red blood cells in the collection device.
The best way to avoid the affect of settling is to test the sample immediately. If there is a
delay in testing of a minute or more, the sample must be remixed thoroughly:
❏ If the sample is in a collection tube, invert the tube gently 10 times.
❏ If the sample is in a syringe, roll the syringe between the palms for five seconds in one
direction, then roll in a second direction for five seconds, then gently invert repeatedly for
five seconds. Note that it may not be possible to adequately mix a blood sample in a 1 mL
syringe. Samples from 1 mL syringes should not be used to determine hematocrit if testing
is delayed. Discard one or two drops of blood from a syringe before filling a cartridge.
■ Low hematocrit results can be caused by contamination of flush solutions in an arterial or
venous line.
❏ Back flush a line with a sufficient amount of blood to remove intravenous solutions,
heparin or medications that may contaminate the sample. Five to six times the volume of
the catheter, connectors and needle is recommended.

Cartridge Comparison
The performance characteristics of the sensors are equivalent in all cartridge configurations. System
difference analysis was performed on 40 patient samples using the i-STAT 6+ and i-STAT E3+ cartridges.
In the 15–30 %PCV range the average difference was 0.462. In the 30–50 %PCV range the average
difference was 0.097.

Calculated Result for Hemoglobin

The i-STAT System provides a calculated hemoglobin result which is determined as follows7:
hemoglobin (g/dL) = hematocrit (% PCV) x 0.34
hemoglobin (g/dL) = hematocrit (decimal fraction) x 34
To convert a hemoglobin result from g/dL to mmol/L, multiply the displayed result by 0.621. The
calculation of hemoglobin from hematocrit assumes a normal MCHC.

HEMATOCRIT Art: 714178-01F Rev. Date: 02/28/05

References
1. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
2. NCCLS. Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard
- Third Edition. NCCLS document H7-A3 [ISBN 1-56238-413-9]. NCCLS, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA, 2000.
3. B.E. Statland, Clinical Decision Levels for Lab Tests (Oradell, NJ: Medical Economic Books, 1987).
4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline.
NCCLS document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA 1995.
5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P [ISBN 1-
56238-020-6]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1986.
7. J.D. Bower, P.G. Ackerman and G. Toto, eds., “Evaluation of Formed Elements of Blood,” in Clinical
Laboratory Methods (St. Louis: The C.V. Mosby Company, 1974).

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and
Company, Franklin Lakes, NJ USA. Coulter S Plus is a registered trademark of Beckman Coulter Incorporated, Fullerton, CA USA. Cell-Dyn is
a registered trademark of Abbott Laboratories, Abbott Park, IL USA. SE9500 is a trademark of Sysmex America Inc., Mundelein, IL USA. STAT
Profile is a registered trademark of Nova Biomedical, Waltham, MA USA.

Rev. Date: 02/28/05 Art: 714178-01F HEMATOCRIT

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714178-01F Rev. Date: 02/28/05

 IONIZED CALCIUM/ICA

Ionized calcium is measured by ion-selective electrode potentiometry. In the calculation of results

for ionized calcium concentration is related to potential through the Nernst equation. Results are
measured at 37°C.
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.1
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for ionized calcium, as part of the i-STAT System, is intended for use in the in vitro
quantification of ionized calcium in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives. For cartridges
that contain a sensor for the measurement of ionized calcium, a list of reactive ingredients is indicated
below:

Reactive Ingredient
Calcium (Ca2+)

Metrological Traceability
The i-STAT System test for ionized calcium measures ionized calcium (i.e. free calcium ion) amount-
of-substance concentration in the plasma fraction of arterial, venous, or capillary whole blood
(dimension mmol L-1) for in vitro diagnostic use. Ionized calcium values assigned to i-STAT’s controls
and calibration verification materials are traceable to the U.S. National Institute of Standards and
Technology (NIST) standard reference material SRM956. i-STAT System controls and calibration
verification materials are validated for use only with the i-STAT System and assigned values may not be
commutable with other methods. Further information regarding metrological traceability is available
from i-STAT Corporation.

Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range2
Ionized Calcium/iCa mmol/L 0.25 – 2.50 1.12 – 1.32
mg/dL 1.0 – 10.0 4.5 – 5.3
*The i-STAT System can be configured with the preferred units.

To convert a result from mmol/L to mg/dL, multiply the mmol/L value by 4. To convert mmol/L to
mEq/L multiply the mmol/L value by 2.
The reference range programmed into the analyzer and shown above is intended to be used as a guide
for the interpretation of results. Since reference ranges may vary with demographic factors such as
age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Art: 714179-01F Rev. Date: 01/25/05

 Clinical Significance
Although most of the calcium in blood is bound to protein or complexed to smaller anionic species,
the biologically active fraction of calcium is free ionized calcium. Through its role in a number of
enzymatic reactions and in membrane transport mechanisms, ionized calcium is vitally important
in blood coagulation, nerve conduction, neuromuscular transmission and in muscle contraction.
Increased ionized calcium (hypercalcemia) may result in coma. Other symptoms reflect neuromuscular
disturbances, such as hyperreflexia and/or neurologic abnormalities such as neurasthenia, depression or
psychosis. Decreased ionized calcium (hypocalcemia) often results in cramps (tetany), reduced cardiac
stroke work and depressed left ventricular function. Prolonged hypocalcemia may result in bone
demineralization (osteoporosis) which can lead to spontaneous fractures. Measurements of ionized
calcium have proven of value under the following clinical conditions: transfusion of citrated blood,
liver transplantation, open heart surgery, neonatal hypocalcemia, renal disease, hyperparathyroidism,
malignancy, hypertension and pancreatitis.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A3. Venous blood samples were
collected in lithium heparin Vacutainer® tubes and analyzed in duplicate on the i-STAT System and on
the comparative methods within 10 minutes of each other.
Deming regression analysis4 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
Interference studies were based on NCCLS guideline EP7-P.5
* The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.3 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (mmol/L)

Aqueous Control Mean SD %CV
Level 1 1.60 0.017 1.1
Level 3 0.84 0.012 1.4

IONIZED CALCIUM Art: 714179-01F Rev. Date: 01/25/05

Method Comparison (mmol/L)
Radiometer ICA1 Nova STAT Profile
n 47 57
Sxx 0.009 0.017
Syy 0.017 0.017
Slope 0.925 0.960
Int’t 0.113 0.062
Sy.x 0.035 0.029
Xmin 0.46 0.53
Xmax 2.05 2.05
r 0.982 0.982

Factors Affecting Results*

Venous stasis (prolonged tourniquet application) and forearm exercise may increase ionized calcium
due to a decrease in pH caused by localized production of lactic acid6. Exposing the sample to air will
cause an increase in pH due to the loss of CO2 which will decrease ionized calcium.
Heparin binds calcium. Each unit of heparin added per mL of blood will decrease ionized calcium by
0.01 mmol/L.6 Therefore, the correct ratio of heparin anticoagulant to blood must be achieved during
sample collection. Intravenous injection of 10,000 units of heparin has been shown in adults to cause a
significant decrease of ionized calcium of about 0.03 mmol/L.6 Use only unheparinized sample transfer
devices when using i-STAT’s aqueous control and calibration verification materials.
Hemodilution of the plasma by more than 20% associated with priming cardiopulmonary bypass
pumps, plasma volume expansion or other fluid administration therapies using certain solutions may
cause clinically significant error on sodium, chloride, ionized calcium and pH results. These errors
are associated with solutions that do not match the ionic characteristics of plasma. To avoid these
errors when hemodiluting by more than 20%, use physiologically balanced multi-electrolyte solutions
containing low-mobility anions (e.g. gluconate) such as Normosol®-R (Abbott Laboratories), Plasma-
Lyte®-A (Baxter Healthcare Corporation), and Isolyte®-S (B Braun Medical) rather than solutions such
as normal saline or Ringer’s Lactate.
Affect of Freezing: Cartridges should be stored between 2 and 8 ºC. Freezing should be avoided.
Freezing will cause the ionized calcium in the calibrant fluid to precipitate, which will cause sample
results to be falsely elevated. To help avoid freezing, do not store cartridges against the walls of the
refrigerator. If freezing is suspected, test a sample of the cartridges using i-STAT controls.

Interferent Effect
β-hydroxybutyrate 20 mmol/L β-hydroxybutyrate will decrease ionized calcium results by
0.1 mmol/L.
Lactate 20 mmol/L lactate will decrease ionized calcium results by 0.05 mmol/L.
Magnesium 1.0 mmol/L magnesium above normal will increase ionized calcium results by
0.04 mmol/L.
Salicylate 4.34 mmol/L salicylate will decrease ionized calcium results by 0.1 mmol/L.
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Rev. Date: 01/25/05 Art: 714179-01F IONIZED CALCIUM

References
1. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
2. P.C. Painter, J.Y. Cope, J.L. Smith, “Reference Ranges, Table 41–20” in Tietz Textbook of Clinical
Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders Company,
1994).
3. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898, USA 1995.
4. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
5. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P [ISBN
1-56238-020-6]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898,
USA 1986.
6. D. Fraser, G. Jones, S.W. Kooh, and I. Raddle, “Calcium and Phosphate Metabolism” in Tietz Textbook
of Clinical Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders
Company, 1994).

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and
Company, Franklin Lakes, NJ USA. ICA 1 is a trademark of Radiometer Medical A/S, Copenhagen, Denmark. Stat Profile is a registered trademark
of Nova Biomedical, Waltham, MA USA. Normosol is a trademark of Abbott Laboratories, Abbott Park, IL, USA. Plasma-Lyte is a registered
trademark of Baxter International Inc., Deerfield, IL, USA. Isolyte is a trademark of B. Braun Medical Inc., Germany.

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714179-01F Rev. Date: 01/25/05

 PO2 AND CALCULATED OXYGEN SATURATED
(sO2)

PO2 is measured amperometrically. The oxygen sensor is similar to a conventional Clark electrode.
Oxygen permeates through a gas permeable membrane from the blood sample into an internal
electrolyte solution where it is reduced at the cathode. The oxygen reduction current is proportional to
the dissolved oxygen concentration.
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.1
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for PO2, as part of the i-STAT System, is intended for use in the in vitro quantification of
oxygen partial pressure in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives.
Metrological Traceability
The i-STAT System test for oxygen partial pressure measures oxygen partial pressure in arterial, venous,
or capillary whole blood (dimension kPa) for in vitro diagnostic use. PO2 values assigned to i-STAT’s
controls and calibration verification materials are traceable to U.S. National Institute of Standards and
Technology (NIST) standard reference materials via commercially available certified specialty medical
gas standards. i-STAT System controls and calibration verification materials are validated for use only
with the i-STAT System and assigned values may not be commutable with other methods. Further
information regarding metrological traceability is available from i-STAT Corporation.

Expected Values
Reportable Reference
Test Units* Range Range2
PO2 mmHg 5 – 800 80 – 105
kPa 0.7 – 106.6 10.7 – 14.0
sO2** % not applicable 95 – 98

*The i-STAT System can be configured with the preferred units.

** Calculated

To convert PO2 results from mmHg to kPa, multiply the mmHg value by 0.133.
The reference ranges shown are for a healthy population. Interpretation of blood gas measurements
depend on the underlying condition (eg. patient temperature, ventilation, posture and circulatory
status).

Art: 714180-01E Rev. Date: 01/25/05

 Clinical Significance
PO2 (partial pressure of oxygen) is a measurement of the tension or pressure of oxygen dissolved in
blood. Some causes for decreased values of PO2 include decreased pulmonary ventilation (e.g. airway
obstruction or trauma to the brain), impaired gas exchange between alveolar air and pulmonary
capillary blood (e.g. bronchitis, emphysema, or pulmonary edema), and alteration in the flow of blood
within the heart or lungs (e.g. congenital defects in the heart or shunting of venous blood into the
arterial system without oxygenation in the lungs).
sO2 (oxygen saturation) is the amount of oxyhemoglobin expressed as a fraction of the total amount of
hemoglobin able to bind oxygen (oxyhemoglobin plus deoxyhemoglobin).

(X3 + 150X)
sO2=100 __________________
X3 + 150X + 23400
(0.48(pH-7.4)-0.0013(HCO3-25))
where X = PO2 • 10

sO2 is calculated from measured PO2 and pH and from HCO 3 calculated from measured PCO2
and pH. However, this calculation assumes normal affinity of oxygen for hemoglobin (it does not
take into consideration erythrocyte diphosphoglycerate (2,3-DPG) concentrations which affect the
oxyhemoglobin dissociation curve) and assumes that normal amounts of disfunctional hemoglobin
(carboxy-, met- and sulfhemoglobin) are present. Oxygen saturation is a useful predictor of the amount
of oxygen that is available for tissue perfusion. Some causes for decreased values of sO2 include low
PO2 or impaired ability of hemoglobin to carry oxygen.

Temperature “Correction” Algorithm

PO2 is a temperature-dependent quantity and is measured at 37°C. The PO2 reading at a body
temperature other than 37°C can be ‘corrected’ by entering the patient’s temperature on the chart
page of the analyzer. See section 12 ‘Procedure for Cartridge Testing’ in the i-STAT 1 System Manual or
section 11 ‘Patient and Control Sample Testing’ in the i-STAT System Manual for details. In this case,
blood gas results will be displayed at both 37°C and the patient’s temperature. The PO2 at the patient’s
temperature (Tp) is calculated as follows3:

Note: The input of patient temperature on the chart page is only possible when a cartridge
contains pH, PCO2, and PO2 sensors.

Performance Characteristics
The typical performance data summarized below was collected in a health care facility by health care
professionals trained in the use of the i-STAT System and comparative method.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A4. Arterial blood samples were
collected from hospital patients in 3cc blood gas syringes and were analyzed in duplicate on the i-STAT
System and the comparative method within 5 minutes of each other.

PO2 Art: 714180-01E Rev. Date: 01/25/05

Deming regression analysis5 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is
the standard error of the estimate, and r is the correlation coefficient.* Method comparisons will vary
from site to site due to differences in sample handling, comparative method calibration and other site
specific variables.
* The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.6 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (mmHg)

Aqueous Control Mean SD %CV
Level 1 65.1 3.12 4.79
Level 3 146.5 6.00 4.10

Method Comparison (mmHg)

Radiometer Radiometer Bayer 845

ABL500 ABL700
n 45 29 30
Sxx 3.70 2.04 3.03
Syy 2.78 2.64 3.28
Slope 1.023 0.962 1.033
Int’t -2.6 1.2 -2.9
Sy.x 2.52 3.53 3.44
Xmin ---- 39 31
Xmax ---- 163 185
r 0.996 0.990 0.996

Factors Affecting Results*

Exposure of the sample to air will cause an increase in PO2 when values are below 150 mmHg and a
decrease in PO2 when values are above 150 mmHg (approximate PO2 of room air).
Standing anaerobically at room temperature will decrease pH at a rate of 0.03 per hour, will increase
PCO2 by approximately 4 mmHg per hour and will decrease PO2 at a rate of 2–6 mmHg per hour.6
Do not ice samples before testing – PO2 results may be falsely elevated in cold samples. Do not use a
cold cartridge – PO2 results may be falsely decreased if the cartridge is cold.
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Factors Affecting Calculated Results

sO2 values calculated from a measured PO2 and an assumed oxyhemoglobin dissociation curve may
differ significantly from the direct measurement.3

Rev. Date: 01/25/05 Art: 714180-01E PO2

References
1. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
2. B.E. Statland, Clinical Decision Levels for Lab Tests (Oradel, NJ: Medical Economic Books, 1987).
3. NCCLS. Blood Gas and pH Analysis and Related Measurements; Approved Guideline. NCCLS document
C46-A [ISBN 1-56238-444-9]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-
1898 USA, 2001.
4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898, USA 1995.
5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. E.L. Pruden, O. Siggaard-Andersen, and N.W. Tietz, “Blood Gases and pH,” in Tietz Textbook of
Clinical Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders
Company, 1994).

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. ABL is a registered trademark of Radiometer Medical A/S,
Copenhagen,Denmark. Bayer 845 is manufactured by Bayer Diagnostics, Tarrytown, NY USA.

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714180-01E Rev. Date: 01/25/05

 pH

pH is measured by direct potentiometry. In the calculation of results for pH, concentration is related to
potential through the Nernst equation. Results are reported at 37°C.
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.1
If results appear inconsistent with the clinical assessment, the patient sample should be retested using
another cartridge.

Intended Use
The test for pH, as part of the i-STAT System, is intended for use in the in vitro quantification of pH in
arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives. For cartridges that
contain a sensor for the measurement of pH, a list of reactive ingredients is indicated below:

Reactive Ingredient
Hydrogen Ion (H+)

Metrological Traceability
The i-STAT System test for pH measures the hydrogen ion amount-of-substance concentration in the
plasma fraction of arterial, venous, or capillary whole blood (expressed as the negative logarithm of
the relative molal hydrogen ion activity) for in vitro diagnostic use. pH values assigned to i-STAT’s
controls and calibration verification materials are traceable to the U.S. National Institute of Standards
and Technology (NIST) standard reference materials SRMs 186-I, 186-II, 185, and 187. i-STAT System
controls and calibration verification materials are validated for use only with the i-STAT System
and assigned values may not be commutable with other methods. Further information regarding
metrological traceability is available from i-STAT Corporation.

Expected Values
Reportable Reference
Test/Abbreviation Units Range Range
pH 6.50 – 8.00 7.35 – 7.452 7.31 – 7.41*
(arterial) (venous)
* Calculated from Siggaard-Andersen nomogram.

Venous samples normally measure 0.01 – 0.03 pH units lower than arterial samples.
The reference range programmed into the analyzer and shown above is intended to be used as a guide
for the interpretation of results. Since reference ranges may vary with demographic factors such as
age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Art: 714181-01F Rev. Date: 01/25/05

 Clinical Significance
pH is an index of the acidity or alkalinity of the blood with an arterial pH of <7.35 indicating an
acidemia and >7.45 alkalemia.3

Temperature “Correction” Algorithm

pH is a temperature-dependent quantity that is measured on the i-STAT System at 37°C. The pH reading
at a body temperature other than 37°C can be ‘corrected’ by entering the patient’s temperature on the
chart page of the analyzer. See section 12 ‘Procedure for Cartridge Testing’ in the i-STAT 1 System
Manual or section 11 ‘Patient and Control Sample Testing’ in the i-STAT System Manual for details. In
this case, blood gas results will be displayed at both 37°C and the patient’s temperature. The pH at the
patient’s temperature (Tp) is calculated as follows4:

Note: The input of patient temperature on the chart page is only possible when a cartridge
contains pH, PCO2, and PO2 sensors.

Performance Characteristics
The performance characteristics of the sensors are equivalent in all cartridge configurations.
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A5. Venous blood samples were
collected in evacuated tubes and arterial samples were collected in blood gas syringes with lithium
heparin anticoagulant. All sample were analyzed in duplicate on the i-STAT System and on the
comparative methods within 10 minutes of each other. Arterial blood samples were collected from
hospital patients in 3 mL blood gas syringes and were analyzed in duplicate on the i-STAT-System and
the comparative method within 5 minutes of each other.
Deming regression analysis6 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
* The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.4 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data
Aqueous Control Mean SD %CV
Level 1 7.165 0.005 0.08
Level 3 7.656 0.003 0.04

pH Art: 714181-01F Rev. Date: 01/25/05

Method Comparison
Radiometer Nova Radiometer
IL BGE ICA 1 STAT Profile 5 ABL500
n 62 47 57 45
Sxx 0.005 0.011 0.006 0.004
Syy 0.009 0.008 0.008 0.008
Slope 0.974 1.065 1.058 1.0265
Int't 0.196 -0.492 -0.436 -0.1857
Sy.x 0.012 0.008 0.010 0.0136
Xmin 7.210 7.050 7.050
Xmax 7.530 7.570 7.570
r 0.985 0.990 0.9920 .986

Factors Affecting Results*

Venous stasis (prolonged tourniquet application) and forearm exercise may decrease pH due to
localized production of lactic acid. Exposing the sample to air will cause an increase in pH due to the
loss of CO2. pH decreases on standing anaerobically at room temperature at a rate of 0.03 pH units
per hour.3
Hemodilution of the plasma by more than 20% associated with priming cardiopulmonary bypass
pumps, plasma volume expansion or other fluid administration therapies using certain solutions may
cause clinically significant error on sodium, chloride, ionized calcium and pH results. These errors
are associated with solutions that do not match the ionic characteristics of plasma. To avoid these
errors when hemodiluting by more than 20%, use physiologically balanced multi-electrolyte solutions
containing low-mobility anions (e.g. gluconate) such as Normosol®-R (Abbott Laboratories), Plasma-
Lyte®-A (Baxter Healthcare Corporation), and Isolyte®-S (B Braun Medical) rather than solutions such
as normal saline or Ringer’s Lactate.
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Rev. Date: 01/25/05 Art: 714181-01F pH

References
1. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
2. P.C. Painter, J.Y. Cope, J.L. Smith, “Reference Ranges, Table 41–20” in Tietz Textbook of
Clinical Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders
Company, 1994).
3. E.L. Pruden, O. Siggaard-Andersen, and N.W. Tietz, Blood Gases and pH, in Tietz Textbook of Clinical
Chemistry, Second Edition, ed. C.A. Burtis and E.R. Ashwood. (Philadelphia: W.B. Saunders Company,
1994.
4. NCCLS. Blood Gas amd pH Analysis and Related Measurements; Approved Guideline. NCCLS document
C46-A [ISBN 1-56238-444-9]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-
1898, USA 2001.
5. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898, USA 1995.
6. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. BGE is a registered trademark of Instumentation Laboratory,
Lexington MA. ICA 1 is a trademark of Radiometer Medical A/S, Copenhagen, Denmark. Stat Profile is a registered trademark of Nova Biomedical,
Waltham MA USA. ABL is a registered trademark of Radiometer Medical A/S, Copenhagen Denmark.Normosol is a trademark of Abbott
Laboratories, Abbott Park, IL, USA. Plasma-Lyte is a registered trademark of Baxter International Inc., Deerfield, IL, USA. Isolyte is a trademark of
B. Braun Medical Inc., Germany.

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714181-01F Rev. Date: 01/25/05

 PCO2 AND CALCULATED VALUES FOR
HCO3, TCO2, BASE EXCESS AND ANION GAP

PCO2 is measured by direct potentiometry. In the calculation of results for PCO2, concentration is
related to potential through the Nernst equation. Results are measured at 37°C when using cartridges
that require thermal control and corrected to 37°C when using cartridges that do not require thermal
control.

Calculated Values
When a cartridge includes sensors for both pH and PCO2, bicarbonate (HCO3), total carbon dioxide
(TCO2) and base excess (BE) are calculated.1
log HCO3 = pH + log PCO2 – 7.608
TCO2 = HCO3 + 0.03 PCO2
BEecf = HCO3 – 24.8 + 16.2 (pH – 7.4)
BEb = (1 - 0.014*Hb) * [ HCO3 - 24.8 + (1.43 * Hb + 7.7) * (pH - 7.4) ]
When a cartridge includes sensors for sodium, potassium, chloride,
pH and PCO2, anion gap can be calculated.
Anion Gap = (Na + K) – (Cl + HCO3)
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.2 If results appear inconsistent with the clinical assessment, the patient sample
should be retested using another cartridge.

Intended Use
The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of
carbon dioxide partial pressure in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included
in the cartridge configuration), sensors for the measurement of specific analytes, and a buffered
aqueous calibrant solution that contains known concentrations of analytes and preservatives. For
cartridges that contain a sensor for the measurement of PCO2, a list of reactive ingredients is
indicated below:

Reactive Ingredient
Carbon Dioxide (CO2)

Metrological Traceability
The i-STAT System test for carbon dioxide partial pressure measures carbon dioxide partial pressure
in arterial, venous, or capillary whole blood (dimension kPa) for in vitro diagnostic use. PCO2 values
assigned to i-STAT’s controls and calibration verification materials are traceable to U.S. National
Institute of Standards and Technology (NIST) standard reference materials via commercially available
certified specialty medical gas standards. i-STAT System controls and calibration verification materials
are validated for use only with the i-STAT System and assigned values may not be commutable with
other methods. Further information regarding metrological traceability is available from i-STAT
Corporation.

Art: 714182-01H Rev. Date: 01/25/05

 Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range
(arterial) (venous)
Partial Pressure
Carbon Dioxide/PCO2 mmHg 5 – 130 35 – 453 41 – 51
kPa 0.67 – 17.33 4.67 – 6.00 5.47 – 6.80
Bicarbonate/HCO3 mmol/L 1.0 – 85.0 22 – 26** 23 – 28**
Total Carbon
Dioxide/TCO2 mmol/L 1 – 85 23 – 27** 24 – 29**
Base Excess/BE mmol/L (-30) – (+30) (-2) – (+3)3 (-2) – (+3)3
Anion Gap/AnGap mmol/L (-10) – (+99) 10 – 203 10 – 203
*The i-STAT System can be configured with the preferred units.
**Calculated from Siggaard-Andersen nomogram.4

For TCO2, values measured on serum or plasma by chemistry analyzers may be slightly lower than TCO2 calculated from pH and PCO2 due to
loss of CO2 during non-anaerobic handling.5 Up to 6mmol/L CO2 can be lost per hour by exposure of the sample to air.6

To convert PCO2 results from mmHg to kPa, multiply the mmHg value by 0.133.
The reference ranges programmed into the analyzer and shown above are intended to be used as guides
for the interpretation of results. Since reference ranges may vary with demographic factors such as
age, gender and heritage, it is recommended that reference ranges be determined for the population
being tested.

Clinical Significance
PCO2 along with pH is used to assess acid-base balance. PCO2 (partial pressure of carbon dioxide),
the respiratory component of acid-base balance, is a measure of the tension or pressure of carbon
dioxide dissolved in the blood. PCO2 represents the balance between cellular production of CO2 and
ventilatory removal of CO2 and a change in PCO2 indicates an alteration in this balance. Causes of
primary respiratory acidosis (increase in PCO2) are airway obstruction, sedatives and anesthetics,
respiratory distress syndrome, and chronic obstructive pulmonary disease. Causes of primary
respiratory alkalosis (decreased PCO2) are hypoxia (resulting in hyperventilation) due to chronic heart
failure, edema and neurologic disorders, and mechanical hyperventilation.
HCO3 (bicarbonate), the most abundant buffer in the blood plasma, is an indicator of the buffering
capacity of blood. Regulated primarily by the kidneys, HCO3 is the metabolic component of acid-base
balance. Causes of primary metabolic acidosis (decrease in HCO3) are ketoacidosis, lactate acidosis
(hypoxia), and diarrhea. Causes of primary metabolic alkalosis (increase in HCO3) are vomiting and
antacid treatment.
TCO2 (total carbon dioxide) is either measured on plasma by automated chemistry analyzers or is
calculated from pH and PCO2 measured on whole blood gas analyzers. TCO2 is a measure of carbon
dioxide which exists in several states: CO2 in physical solution or loosely bound to proteins, HCO3 or
CO3 ions, and carbonic acid (H2CO3). Bicarbonate ions make up all but approximately 2 mmol/L of the
total carbon dioxide of plasma. Measurement of TCO2 as part of an electrolyte profile is useful chiefly
to evaluate HCO3 concentration. TCO2 and HCO3 are useful in the assessment of acid-base imbalance
(along with pH and PCO2) and electrolyte imbalance.
Base excess of the extracellular fluid or standard base excess is defined as the concentration of
titratable base minus the concentration of titratable acid when titrating the average intracellular fluid
(plasma plus interstitial fluid) to an arterial plasma pH of 7.40 at PCO2 of 40 mmHg at 37°C. Excess
concentration of base in the average ECF remains virtually constant during acute changes in the PCO2
and reflects only nonrespiratory component of pH-disturbances.

PCO2 Art: 714182-01H Rev. Date: 01/25/05

Anion gap is reported as the difference between the commonly measured cations sodium and
potassium and the commonly measured anions chloride and bicarbonate. The size of the gap reflects
unmeasured cations and anions and is therefore an analytical gap. Physiologically, a deficit of anions
cannot exist. While relatively nonspecific, anion gap is useful for the detection of organic acidosis
due to an increase in anions that are difficult to measure. Anion gap can be used to classify metabolic
acidosis into high and normal anion gap types. Anion gap may be only slightly increased in diarrhea
and renal failure, but elevated (often >25) due to an increase in organic anions in lactic acidosis,
ketoacidosis (alcoholic, diabetic, starvation) and uremia, an increase in inorganic anions in uremia,
and an increase in anions from drugs such a salicylate and carbenicillin or toxins such as methanol
and ethanol.

Temperature “Correction” Algorithm

PCO2 is a temperature-dependent quantity and is measured at 37°C. The PCO2 reading at a body
temperature other than 37°C can be ‘corrected’ by entering the patient’s temperature on the chart
page of the analyzer. See section 12 ‘Procedure for Cartridge Testing’ in the i-STAT 1 System Manual
or section 11 ‘Patient and Control Sample Testing’ in the i-STAT System Manual for details. In this
case, blood gas results will be displayed at both 37°C and the patient’s temperature. The PCO2 at the
patient’s temperature (Tp) is calculated as follows1:

Note: The input of patient temperature on the chart page is only possible when a cartridge
contains pH, PCO2, and PO2 sensors.

Performance Characteristics
The performance characteristics of the sensors are equivalent in all cartridge configurations.
The typical performance data summarized below was collected in a health care facility by health care
professionals trained in the use of the i-STAT System and comparative methods.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A7. Venous blood samples were
collected in blood gas syringes. To measure TCO2, the sample was centrifuged to obtain plasma. All
samples were analyzed in duplicate on the i-STAT System and on the comparative methods within 10
minutes of each other. Arterial blood samples were collected from hospital patients in 3cc blood gas
syringes and were analyzed in duplicate on the i-STAT System and the comparative method within
5 minutes of each other.
Deming regression analysis8 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Method comparisons will vary from site to site due to differences in sample handling, comparative
method calibration and other site specific variables.
* The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.7 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Rev. Date: 01/25/05 Art: 714182-01H PCO2

 Precision Data (mmHg)
Aqueous Control Mean SD %CV
Level 1 63.8 1.57 2.5
Level 3 19.6 0.40 2.0

Method Comparison (mmHg)

PCO2 TCO2 TCO2 PCO2

IL BGE IL BGE Beckman CX®3 Radiometer ABL500
n 62 62 51 29
Sxx 0.69 0.40 0.55 0.74
Syy 1.24 0.84 0.55 0.53
Slope 1.003 1.136 1.155 1.016
Int’t -0.8 -4.1 -2.6 1.1
Sy.x 1.65 1.38 1.56 0.32
Xmin 30.4 19.3 18.3 28
Xmax 99.0 43.9 36.1 91
r 0.989 0.965 0.935 0.999

Factors Affecting Results*

Exposing the sample to air allows CO2 to escape which causes PCO2 to decrease and pH to increase
and HCO3 and TCO2 to be under-estimated. The use of partial-draw tubes (evacuated tubes that are
adjusted to draw less than the tube volume, e.g. a 5 mL tube with enough vacuum to draw only 3 mL)
is not recommended for use with the i-STAT System because of the potential for decreased measured
PCO2 results and calculated HCO3 and TCO2 values. Under-filling blood collection tubes may also
cause decreased PCO2 results. Care must also be taken to eliminate “bubbling” of the sample with a
pipette when filling a cartridge to avoid the loss of CO2 in the blood.
Allowing blood to stand (without exposure to air) before testing allows PCO2 to increase and pH to
decrease, which will cause HCO3 and TCO2 to be over-estimated, due to metabolic processes.
For patients administered propofol (Diprivan®) or thiopental sodium (syn. thiomebumal sodium,
penthiobarbital sodium, thiopentone sodium, thionembutal, Pentothal Sodium®, Nesdonal Sodium®,
Intraval Sodium®, Trapanal®, and Thiothal Sodium9), i-STAT recommends the use of G3+, CG4+,
CG8+, EG6+ and EG7+ cartridges, which are free from clinically significant interference at all relevant
therapeutic doses. i-STAT does not recommend the use of EC8+ cartridges for patients receiving
propofol (Diprivan®) or thiopental sodium.

* It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

PCO2 Art: 714182-01H Rev. Date: 01/25/05

References
1. NCCLS. Blood Gas and pH Analysis and Related Measurements; Approved Guideline. NCCLS document
C46-A [ISBN 1-56238-444-9]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-
1898, USA 2001.
2. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
3. P.C. Painter, J.Y. Cope, J.L. Smith, “Reference Ranges, Table 41–20” in Tietz Textbook of Clinical
Chemistry—Second Edition, C.A. Burtis and E.R. Ashwood, eds. (Philadelphia: W.B. Saunders Company,
1994).
4. E.L. Pruden, O. Siggaard-Andersen, and N.W. Tietz, Blood Gases and pH, in Tietz Textbook of
Clinical Chemistry, Second Edition, ed. C.A. Burtis and E.R. Ashwood. (Philadelphia: W.B. Saunders
Company, 1994).
5. J.P.J. Ungerer, M.J. Ungerer, and W.J.H Vermaak, Discordance Between Measured and Calculated
Total Carbon Dioxide, Clinical Chemistry 36.12, 1990. 2093-2096.
6. N.W. Tietz, E.L. Pruden, O. Siggaard-Andersen, Electrolytes, in Tietz Textbook Clinical Chemistry
Second Edition, ed. C.A. Burtis and E.R. Ashwood. (Philadelphia: W.B. Saunders Company 1994).
7. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline.
NCCLS document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA 1995.
8. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
9. The Merck Index, Eleventh Edition, Merck & Co., Inc., NJ 1989.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. CX®3 is a registered trademark of Beckman Instruments, Inc.,
Brea, CA USA. Diprivan is a registered trademark of the AstraZeneca group of companies. Pentothal Sodium is a registered trademark of Abbott
Labs., USA. Nesdonal Sodium is a registered trademark of Specia, France. Intraval Sodium is a registered trademark of May and Baker, Ltd.,
England. Trapanal is a registered trademark of Chemische Fabrik Promonta, Germany. ABL is a registered trademark of Radiometer Medical A/S,
Copenhagen Denmark. BGE is a registered trademark of Instrumentation Laboratory, Lexington MA.

Rev. Date: 01/25/05 Art: 714182-01H PCO2

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2004 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714182-01H Rev. Date: 01/25/05

 CREATININE/CREA

Creatinine is measured amperometrically. Creatinine is hydrolyzed to creatine in a reaction catalyzed

by the enzyme creatinine amidohydrolase. Creatine is then hydrolyzed to sarcosine in a reaction
catalyzed by the enzyme creatine amidinohydrolase. The oxidation of sarcosine, catalyzed by the
enzyme sarcosine oxidase, produces hydrogen peroxide (H2O2). The liberated hydrogen peroxide is
oxidized at the platinum electrode to produce a current which is proportional to the sample creatinine
concentration.
Creatinine Amidohydrolase
Creatinine + H2O Creatine
Creatine Amidinohydrolase
Creatine + H2O Sarcosine + Urea
Sarcosine Oxidase
Sarcosine + O2 + H2O Glycine + Formaldehyde + H2O2
H2O2 O2 + 2H+ +2e-
See below for information on factors affecting results. Certain substances, such as drugs, may affect
analyte levels in vivo.1
If results appear inconsistent with the clinical assessment, the patient sample should be retested
using another cartridge.

INTENDED USE
The test for creatinine, as part of the i-STAT System, is intended for use in the in vitro quantification of
creatinine in arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in
the cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous
calibrant solution that contains known concentrations of analytes and preservatives. For cartridges that
contain a sensor for the measurement of creatinine, a list of reactive ingredients is indicated below:

Reactive Ingredient Biological Source

Creatinine N/A
Creatine Amidinohydrolase Actinobacillus sp.
Creatinine Amidohydrolase Microbial
Sarcosine Oxidase Microbial

Metrological Traceability
The i-STAT System test for creatinine measures creatinine amount-of-substance concentration in the
plasma fraction of arterial, venous, or capillary whole blood (dimension µmol L-1) for in vitro diagnostic
use. Creatinine values assigned to i-STAT’s controls and calibration verification materials are traceable
to the U.S. National Institute of Standards and Technology (NIST) standard reference material SRM909.
i-STAT System controls and calibration verification materials are validated for use only with the
i-STAT System and assigned values may not be commutable with other methods. Further information
regarding metrological traceability is available from i-STAT Corporation.

Art: 714183-01G Rev. Date: 01/25/05

 Expected Values
Reportable Reference
Test/Abbreviation Units* Range Range
2
Creatinine/Crea mg/dL 0.2 – 20.0 0.6 – 1.3
µmol/L 18 – 1768 53 – 115
To convert a creatinine result from mg/dL to µmol/L, multiply the mg/dL value by 88.4.
The i-STAT reference ranges for whole blood listed above are similar to reference ranges derived from
serum or plasma measurements with standard laboratory methods.
The reference range programmed into the analyzer and shown above is intended to be used as a
guide for the interpretation of results. Since reference ranges may vary with demographic factors
such as age, gender and heritage, it is recommended that reference ranges be determined for the
population being tested.
* The i-STAT System can be configured with the preferred units.

Clinical Significance
Elevated levels of creatinine are mainly associated with abnormal renal function and occur whenever
there is a significant reduction in glomerular filtration rate or when urine elimination is obstructed.
The concentration of creatinine is a better indicator of renal function than urea or uric acid because it
is not affected by diet, exercise, or hormones.
The creatinine level has been used in combination with BUN to differentiate between prerenal and
renal causes of an elevated urea/BUN.
Performance Characteristics
The typical performance data summarized below were collected in health care facilities by
professionals trained in the use of the i-STAT System and comparative methods. Clinical settings vary
and some may require different performance characteristics to assess renal function status than others
(e.g., medication dosing, intravenous contrast use, and outpatient clinic). If deemed necessary by a
health care facility, performance data should be obtained in specific clinical settings to assure patients’
needs are met.
Precision data were collected in multiple sites as follows: Duplicates of each control fluid were tested
in the morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics are
presented below.
Method comparison data were collected using NCCLS guideline EP9-A 4. Venous blood samples,
collected in lithium or sodium heparin Vacutainer® tubes, and arterial blood samples, collected in
blood gas syringes, were analyzed in duplicate on the i-STAT System. A portion of each specimen was
centrifuged, and the separated plasma was analyzed on the comparative method.
Deming regression analysis5 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to the estimates of
imprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.*
Interference studies were based on NCCLS guideline EP7.6
*The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.3 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

CREATININE Art: 714183-01G Rev. Date: 01/25/05

Precision Data (mg/dL)
Aqueous Control Mean SD %CV
Level 1 4.7 0.08 1.7
Level 3 0.76 0.05 6.3

Method Comparison (mg/dL)

Hitachi 917 J&J Vitros
n 67 48
Sxx 0.045 0.035
Syy 0.087 0.109
Slope 1.002 1.005
Int’t 0.030 -0.109
Sy.x 0.110 0.229
Xmin 0.3 0.5
Xmax 11.2 12.6
r 0.9987 0.9931

Factors Affecting Results*

Interferent Effect
Acetaminophen Creatinine results will increase by approximately 0.25 mg/dL per every 1
mmol/L of acetaminophen.

Ascorbate 0.227 mmol/L ascorbate will cause a 0.7 mg/dL increase in creatinine.

Bromide 100 mg/dL (12.5 mmol/L) bromide will increase creatinine by 0.8 mg/dL (71
µmol/L) from an initial creatinine concentration of 1.0 mg/dL (88 µmol/L).

CO2 For Crea values below 2 mg/dL:

For PCO2 values above 40 mmHg, the values are increased by 6.9% for every 10
mmHg
For PCO2 values below 40 mmHg, the values are decreased by 6.9% for every
10 mmHg
[Cr]actual = [Cr]istat X { 1 - ( 0.069 X [(PCO2 -40)/10]) }
For Crea values above 2 mg/dL:
For PCO2 values above 40, the values are decreased by 3.7% for every 10
mmHg
For PCO2 values below 40, the values are increased by 3.7% for every 10 mmHg
Cr]actual = [Cr]istat X { 1 - ( 0.037 X [(40 - PCO2 )/10]) }
Creatine 5 mg/dL creatine will cause a 0.20 mg/dL increase in Creatinine.

For clinical situations in which creatine may be elevated, see note (1) below.

N-acetylcysteine 16.6 mmol/L N-acetylcysteine will cause a 0.4 mg/dL increase in creatinine.

Rev. Date: 01/25/05 Art: 714183-01G CREATININE

 Hydroxyurea Hydroxyurea may cause significant errors in the measurement of creatinine
(Droxia®, Hydrea®) with the i-STAT System. Use an alternative method to measure creatinine when
patients have been administered hydroxyurea. See note (2) below for typical
uses of this drug and note (3) below for details of the interference.

Notes: (1) The normal range of creatine concentration in plasma is 0.17

– 0.70 mg/dL (13 – 53 µmol/L) in males and 0.35 – 0.93 mg/dL (27
– 71 µmol/L) in females7. Creatine may be elevated in patients using
creatine supplements, experiencing muscle trauma or other primary
or secondary myopathies, taking statins for hyperlipidemia control,
or in patients with hyperthyroidism or a rare genetic defect of the
creatine transporter protein.

(2) Hydroxyurea is a DNA synthesis inhibitor used in the treatment of

various forms of cancer, sickle cell anemia, and HIV infection. This
drug is used to treat malignancies including melanoma, metastatic
ovarian cancer, and chronic myelogenous leukemia. It is also used in
the treatment of polycythemia vera, thrombocytopenia, and psoriasis.
At typical doses ranging from 500 mg to 2 g/day, concentrations of
hydroxyurea in patients’ blood may be sustained at approximately
100 to 500 µmol/L. Higher concentrations may be observed soon
after dosing or at higher therapeutic doses.

(3) For every 100 µmol/L hydroxyurea in the whole blood sample,
creatinine will be increased by approximately 1.85 mg/dL (164 µmol/
L), up to a whole blood hydroxyurea concentration of at least 921
µmol/L (maximum concentration tested). The magnitude of the bias
is independent of the creatinine level over a range of at least 1.0 mg/
dL (88 µmol/L) to 12.4 mg/dL (1096 µmol/L).

Bicarbonate up to 40 mmol/L, bilirubin up to 20 mg/dL (342 µmol/L), calcium up to 5.0 mg/dL (1.25
mmol/L), dopamine up to 13 mg/dL (0.85 mmol/L), methyldopa up to 2.5 mg/dL (118.4 µmol/L),
salicylate up to 77.5 mg/dL (4.34 mmol/L), sarcosine up to 1.0 mmol/L, and uric acid up to 20 mg/dL
(1190 µmol/L) were tested and found not to interfere with creatinine results.

*It is possible that other interfering substance may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

CREATININE Art: 714183-01G Rev. Date: 01/25/05

References
1. D. S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American
Association of Clinical Chemistry, 1990).
2. B. E. Statland, Clinical Decision Levels for Lab Tests, 2nd ed. (Oradell, NJ: Medical Economics
Company, Inc., 1987).
3. NCCLS. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline.
NCCLS document EP5-A [ISBN 1-56238-368-X]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA 1999.
4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A [ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA 1995.

5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method Comparison
Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P (ISBN 1-
56238-020-6). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1986.
7. Tietz Textbook of Clinical Chemistry 3rd Edition, CA Burtis and ER Ashwood, ed., WB Saunders
Company, 1999, page 1808.

Droxia and Hydrea are registered trademarks of Bristol-Myers Squibb Company, Princeton, NJ.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and
Company, Franklin Lakes, NJ USA. Vitros is a registered trademark of Ortho-Clinical Diagnostics, Rochester, NY.

Rev. Date: 01/25/05 Art: 714183-01G CREATININE

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714183-01G Rev. Date: 01/25/05

 LACTATE/LAC

Lactate is measured amperometrically. The enzyme lactate oxidase, immobilized in the lactate biosensor,
selectively converts lactate to pyruvate and hydrogen peroxide (H2O2). The liberated hydrogen peroxide is oxidized
at a platinum electrode to produce a current which is proportional to the sample lactate concentration.
Lactate Oxidase
L-Lactate + O2 Pyruvate + H2O2
Platinum electrode
H2O2 2H+ + O2 + 2e-

See below for information on factors affecting results. Certain substances, such as drugs, may affect analyte levels
in vivo.1

If results appear inconsistent with the clinical assessment, the patient sample should be retested using another
cartridge.

Intended Use
The test for lactate, as part of the i-STAT System, is intended for use in the in vitro quantification of lactate in
arterial, venous, or capillary whole blood.

Contents
Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in the cartridge
configuration), sensors for the measurement of specific analytes, and a buffered aqueous calibrant solution
that contains known concentrations of analytes and preservatives. For cartridges that contain a sensor for the
measurement of lactate, a list of reactive ingredients is indicated below:

Reactive Ingredient Biological Source

Lactate N/A
Lactate Oxidase Aerococcus Viridans

Metrological Traceability
The i-STAT System test for lactate measures L-lactate amount-of-substance concentration in the plasma fraction
of arterial, venous, or capillary whole blood (dimension mmol L-1) for in vitro diagnostic use. Presently, no
international conventional reference measurement procedure or international conventional calibrator for
lactate is available. Lactate values assigned to i-STAT’s controls and calibration verification materials are
traceable to i-STAT’s working calibrator prepared from sodium L-lactate (Sigma-Aldrich Fluka, >99 % purity).
i-STAT System controls and calibration verification materials are validated for use only with the i-STAT System
and assigned values may not be commutable with other methods. Further information regarding metrological
traceability is available from i-STAT Corporation.

Expected Values
Reportable Reference2
Test/Abbreviation Units* Range Range
(arterial) (venous)
Lactate/Lac mmol/L 0.30 – 20.00 0.36 – 1.25 0.90 – 1.70

mg/dL 2.7 – 180.2 3.2 – 11.3 8.1 – 15.3

To convert a lactate result from mmol/L to mg/dL, multiply the mmol/L value by 9.01.

Art: 714184-01D Rev. Date: 04/16/04

 The i-STAT reference ranges for whole blood listed above are similar to reference ranges derived from serum or
plasma measurements with standard laboratory methods.

The reference range shown above is intended to be used as a guide for the interpretation of results. Since reference
ranges may vary with demographic factors such as age, gender and heritage, it is recommended that reference
ranges be determined for the population being tested.

* The i-STAT System can be configured with the preferred units.

Clinical Significance
Elevated levels of lactate are mainly found in conditions of hypoxia such as shock, hypovolumia, and left
ventricular failure; in conditions associated with diseases such as diabetes mellitus, neoplasia, and liver disease;
and in conditions associated with drugs or toxins such as ethanol, methanol, or salicylates.2
Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care professionals
trained in the use of the i-STAT System and comparative methods.

Precision data were collected using NCCLS guideline EP5-A3. Duplicates of each level of control were tested on
three lots of cartridges over 20 days for a total of 120 replicates.

Method comparison data were collected using NCCLS guideline EP9-A 4. Venous blood samples, collected in
sodium heparin Vacutainer® tubes, and arterial blood samples, collected in blood gas syringes, were analyzed
in duplicate on the i-STAT System. In the plasma study, a portion of each specimen was centrifuged, and the
separated plasma was analyzed on the comparative method.

Deming regression analysis5 was performed on the first replicate of each sample. In the method comparison
table, n is the number of specimens in the data set, Sxx and Syy refer to the estimates of imprecision based on the
duplicates of the comparative and the i-STAT methods respectively, Sy.x is the standard error of the estimate, and r
is the correlation coefficient.*

Interference studies were based on NCCLS guideline EP7.6

*The usual warning relating to the use of regression analysis is summarized here as a reminder: For any analyte, “if the data is collected over
a narrow range, the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from these
estimates may be invalid”.3 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in
overcoming this problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data Aqueous Control n Mean SD %CV

(mmol/L) Level 1 120 6.35 0.08 1.21

Level 3 120 0.81 0.03 3.27

Method Comparison Radiometer ABL 725 Hitachi 917

(mmol/L) (whole blood vs. (i-STAT whole blood vs.
whole blood) Hitachi plasma)
n 47 47
Sxx 0.123 0.084
Syy 0.136 0.079
Slope 1.02 1.06
Int't 0.12 -0.32
Sy.x 0.18 0.17
Xmin 0.80 1.77
Xmax 14.20 14.24
r 0.998 0.997

LACTATE Art: 714184-01D Rev. Date: 04/16/04

Factors Affecting Results*
Special collection procedures are necessary to prevent changes in lactate both during and after the blood is drawn.
For steady state lactate concentrations, patients should be at rest for 2 hours and fasting. Venous samples should be
obtained without the use of a tourniquet or immediately after the tourniquet is applied. Both venous and arterial
samples may be collected into heparinized syringes.

Samples for lactate should be analyzed immediately on drawing as lactate increases by as much as 70% within 30
minutes at 25 ºC as a result of glycolysis.2

Interferent Effect
Bromide 25 mmol/L (200 mg/dL) bromide will decrease lactate results by 40%.

Cysteine 6.4 mmol/L (101 mg/dL) cysteine will decrease lactate results by 11%.

Hydroxyurea Hydroxyurea may cause significant errors in the measurement of lactate with
(Droxia®, Hydrea®) the i-STAT System. Consider using an alternative method to measure lactate
when patients have been administered hydroxyurea. See note (1) below for
typical uses of this drug and note (2) below for details of the interference.

Glycolic Acid: Glycolic acid can cause falsely increased lactate results on the i-STAT System.
Preliminary studies indicated that 10 mmol/L glycolic acid increased lactate
from 1.45 mmol/L to 3.41 mmol/L. See note (3) for details.
*It is possible that other interfering substance may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Notes:

1) Hydroxyurea is a DNA synthesis inhibitor used in the treatment of various forms of cancer, sickle cell
anemia, and HIV infection. This drug is used to treat malignancies including melanoma, metastatic
ovarian cancer, and chronic myelogenous leukemia. It is also used in the treatment of polycythemia
vera, thrombocytopenia, and psoriasis. At typical doses ranging from 500 mg to 2 g/day, concentrations
of hydroxyurea in patients’ blood may be sustained at approximately 100 to 500 µmol/L. Higher
concentrations may be observed soon after dosing or at higher therapeutic doses.

2) For every 100 µmol/L hydroxyurea in the whole blood sample, lactate will be increased by approximately
0.16 mmol/L, up to a whole blood hydroxyurea concentration of at least 921 µmol/L (maximum
concentration tested). The magnitude of the bias is independent of the lactate level over a range of at least
2.8 mmol/L to 16.0 mmol/L.

3) Glycolic acid is a product of ethylene glycol metabolism. Unexpected increased lactate concentrations
caused by glycolic acid may be a clue to the possibility of ethylene glycol ingestion as the cause of an
otherwise unknown high anion gap metabolic acidosis. 7, 8 In a study of 35 patients who had ingested
ethylene glycol, initial glycolic acid concentrations of 0 to 38 mmol/L corresponded to ethylene glycol
levels of 0.97 - 130.6 mmol/L. 7

Acetaldehyde up to 0.6 mg/dL (0.14 mM), acetominophen up to 20 mg/dL (1.3 mM), acetylsalicylic
acid up to 50 mg/dL (2.8 mM), ascorbic acid up to 3 mg/dL (0.17 mM), ß-hydroxybutyric acid up
to 202 mg/dL (16 mM), dopamine up to 13 mg/dL (0.85 mM), formaldehyde up to 1.2 mg/dL (0.40
mM), glycine up to 98 mg/dL (13 mM), pyruvic acid up to 2.6 mg/dL (0.24 mM), and uric acid up
to 25 mg/dL (1.5 mM) were tested and found not to interfere with lactate results. Hematocrit levels
between 25 and 67% were tested and found not to interfere with lactate results.

Rev. Date: 04/16/04 Art: 714184-01D LACTATE

References
1. D.S. Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington, DC: American Association of
Clinical Chemistry, 1990).

2. D.B. Sacks, Carbohydrates, in Tietz Textbook of Clinical Chemistry, Second Edition, ed. C.A. Burtis and E.R.
Ashwood, (Philadelphia: W.B. Saunders Company, 1994).

3. NCCLS. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS document EP5-
A [ISBN 1-56238-368-X]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1999.

4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document EP9-A
[ISBN 1-56238-283-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1995.

5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method Comparison Analysis,”
Clinical Chemistry 25:3, 432 (1979).

6. NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS document EP7-P [ISBN 1-56238-020-6].
NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 1986.

7. Porter WH, Crellin M, Rutter PW, Oeltgen P. Interference by Glycolic Acid in the Beckman Synchron Method for
Lactate: A Useful Clue for Unsuspected Ethylene Glycol Intoxication. Clin Chem 2000; 46:874-875.

8. Morgan, TJ, Clark C, Clague A. Artifactual elevation of measured plasma L-lactate concentration in the presence
of glycolate. Crit Care Med 1999; 27:2177-2179.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ USA. Vacutainer is a registered trademark of Becton Dickinson and Company,
Franklin Lakes, NJ USA. ABL is a registered trademark of Radiometer Medical A/S, Copenhagen, Denmark. Droxia and Hydrea are registered
trademarks of Bristol-Myers Squibb Company, Princeton, NJ.

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714184-01D Rev. Date: 04/16/04

 CELITE ACTIVATED CLOTTING TIME/
(CELITEACT)

The i-STAT® Celite® Activated Clotting Time test, CeliteACT, is a measure of the time required for
complete activation of the coagulation cascade.1
In traditional ACT tests, coagulation is initiated by mixing a whole blood sample with a particulate
activator, and complete activation is indicated when extensive or localized clots form as activated
thrombin converts fibrinogen to fibrin. These clots are mechanically detected.
The i-STAT CeliteACT test is similar to traditional ACT tests except that the endpoint is indicated by
the conversion of a thrombin substrate other than fibrinogen and an electrochemical sensor is used to
indicate the event of this conversion. The substrate used in the electrogenic assay has an amide linkage
that mimics the thrombin-cleaved amide linkage in fibrinogen.
The substrate is H-D-phenylalanyl-pipecolyl-arginine-p-amino-p-methoxydiphenylamine which has the
structure:
Phenylalanine - Pipecolic acid - Arginine -- NH - C6H4 - NH - C6H4 - OCH3
Thrombin cleaves the amide bond at the carboxy- terminus of the arginine residue (denoted by the
two dashes) because the bond structurally resembles the thrombin-cleaved amide linkage in fibrinogen.
The product of the thrombin-substrate reaction is the electrochemically inert tripeptide Phenylalanyl
- Pipecolyl - Arginine and the electroactive compound NH3+ - C6H4 - NH - C6H4 - OCH3 . The
formation of the electroactive compound is detected amperometrically, and the time of detection is
measured in seconds. The test reports the Activated Clotting Time (ACT) as a whole blood time (WBT)
in seconds.
The i-STAT CeliteACT test is calibrated to match the Hemochron Celite FTCA510 using prewarmed tubes.
However, users of the i-STAT®1 analyzer may choose to customize their individual i-STAT locations to
report ACT results as calibrated against the Hemochron Celite ACT using non-prewarmed (ambient)
temperature tubes. This customization affects the Patient path only, and will not be applied to the
Control or the Proficiency Testing pathway.
The customization in effect (prewarm or non-prewarm calibration mode) is identified on the analyzer
screen as PREWRM or NONWRM, respectively. Please note that different locations within a given
hospital may utilize different customization profiles. Prior to patient sample testing, ensure the
appropriate calibration mode is employed. For a comprehensive discussion of this customization
feature, please see the Technical Bulletin entitled “ACT Test Result Calibration Options: PREWARMED
vs. NON-PREWARMED Result Calibration Modes for the i-STAT®1 Analyzer”.
If results appear inconsistent with the clinical assessment, the patient sample should be re-tested using
another cartridge.

Intended Use
The i-STAT Celite Activated Clotting Time (CeliteACT) test cartridge, as part of the i-STAT System, is an
in vitro diagnostic test used to monitor moderate- and high-level heparin therapy through analysis of
arterial and venous whole blood samples.

Art: 714185-01D Rev. Date: 04/16/04

 Contents
Each i-STAT CeliteACT cartridge provides a sample collection chamber, sensors to detect the coagulation
endpoint, and dry reagents necessary to initiate and allow coagulation. Stabilizers and reagents are
coated on a section of the sensor channel and include the following reactive ingredients:

Reactive Ingredient
Diatomaceous Earth
Thrombin Substrate

Metrological Traceability
The i-STAT System test for Celite Activated Clotting Time measures the time interval required
for complete activation, by Celite®, of the coagulation cascade in arterial or venous whole blood
(dimension seconds) for in vitro monitoring of moderate- and high-level heparin therapy. Presently, no
international conventional reference measurement procedure or international conventional calibrator
for CeliteACT is available. CeliteACT values assigned to i-STAT’s controls are traceable to i-STAT’s selected
reference measurement procedure, which employs diatomaceous earth (Celite) activated glass reagent
tubes, an automated timer and traditional viscometric clot detection and is run under specified
temperature and sample conditions. i-STAT System controls are validated for use only with the
i-STAT System and assigned values may not be commutable with other methods. Further information
regarding metrological traceability is available from i-STAT Corporation.

Expected Values
Test/Abbreviation Units Reportable Range Reference Range Reference Range
(PREWRM) (NONWRM)
Activated Clotting seconds 50 - 1000* 74 - 125 84 - 139
Time/ACT

* The range from 80 - 1000 seconds has been verified through method comparison studies.

Clinical Significance
The ACT is primarily used to monitor a patient’s state of anticoagulation due to heparin that
is administered during a medical or surgical procedure. It is commonly employed in cardiac
catheterization, Percutaneous Transluminal Coronary Angioplasty (PTCA), renal dialysis, hemodialysis,
and extra-corporeal circulation during bypass.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods. All data uses the
PREWRM calibration, unless otherwise noted.
Precision data were collected at i-STAT and during clinical trials following a protocol recommended
by i-STAT and using plasma control material. Similar results can be expected in future performance
studies provided the same experimental design and data analysis procedures are followed.

Plasma Control n Mean SD %CV

Level 1 329 221 seconds 18 seconds 8.1
Level 2 438 456 seconds 22 seconds 4.8

CELITE ACT Art: 714185-01D Rev. Date: 04/16/04

Method comparison data were collected using a modification of the NCCLS guideline EP9-A2. Venous
or arterial blood samples were collected in plastic syringes and analyzed in duplicate on the i-STAT
System and in duplicate using the comparative methods. All samples were analyzed immediately
upon collection. The patient populations in the studies were those in which ACT is routinely used.
This includes baseline, heparin-treated, and heparin-reversed samples from from patients undergoing
cardiac catheterization and cardiac bypass.
Deming regression analysis3 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of the
imprecision based on the duplicates of the comparative and i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.
Method comparisons will vary from site to site due to differences in the sample handling, reagent and
instrument systems in use, and other site-specific variables.

Hemchron CA510/FT CA510

Cath Lab Medtronic Hemochron
HR-ACT CA510/FT CA510 CVOR Site 1 Site 2 Site 3
n 270 418 n 35 30 24
Sxx 10.1 19.7 Sxx 15.8 34.2 24.4
Syy 10.7 13.5 Syy 13.0 11.5 20.8
Slope 1.15 0.86 Slope 0.85 1.10 1.19
Int’t -30 -3 Int’t 4 -52 -73
Sy.x 32.5 22.5 Sy.x 43.8 17.4 62.1
Xmin 73 63 Xmin 118 94 125
Xmax 523 763 Xmax 671 735 767
r 0.848 0.903 r 0.912 0.952 0.891

Rev. Date: 04/16/04 Art: 714185-01D CELITE ACT

 Factors Affecting Results*
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Heparin sensitivity was demonstrated using whole blood samples to which varying concentrations of
heparin were added in vitro.
The five graphs below each indicate the response of a different donor with respect to heparin
concentration:

CELITE ACT Art: 714185-01D Rev. Date: 04/16/04

The graphs below indicate the response of the same five donors with respect to the ACT result on the
Medtronic HR-ACT and the Hemochron Celite FTCA 510.

Rev. Date: 04/16/04 Art: 714185-01D CELITE ACT

 Performance of the i-STAT Celite ACT at lower levels of heparin is shown below with two “Low Range”
ACT methods included for comparison:

Medtronic LR-ACT, s

Test Limitations
The i-STAT CeliteACT test is to be used with fresh venous or arterial whole blood samples. The presence
of exogenously added heparin, citrate, oxalate, or EDTA will interfere with test results. Poor technique
in sample collection may also compromise the results. Samples drawn from insufficiently flushed
catheters or from traumatic venipunctures may be contaminated with interfering substances. Samples
should be collected into plastic syringes or tubes. Collection into glass may prematurely activate
coagulation resulting in accelerated clotting times.
The i-STAT ACT test uses Celite brand diatomaceous earth as the activator of the intrinsic pathway.
The result may, therefore, be prolonged in the presence of aprotinin.4 The test is not recommended
for use with patients receiving aprotinin.

CELITE ACT Art: 714185-01D Rev. Date: 04/16/04

The analyzer should remain on a level surface with the display facing up during testing. If the analyzer
is not level, the ACT result may be affected by more than 10%.
Hemodilution may affect test results.
Platelet dysfunction, factor deficiencies, dysprothrombinemias, pharmacological compounds, and
other coagulopathies may affect the results of this test.
The i-STAT ACT test is not affected by hematocrit in the range of 20 - 70%, fibrinogen concentration in
the range from 100 - 500 mg/dL, or sample temperature from 15 - 37ºC.

Storage Instructions
Cartridges in sealed pouches are stable through the expiration date when stored refrigerated at 2 to 8°C
and for two weeks at room temperature (18 - 30°C).
Upon removal from refrigeration, a box of 25 cartridges requires one hour equilibration at room
temperature before use. Individual cartridges require five minutes equilibration. A cartridge should be
used immediately after it is removed from the pouch.

Quality Control
On a daily basis, the performance of all Analyzers in the i-STAT System on site should be verified using
the i-STAT Electronic Simulator.
On receipt of new cartridges, verify that the transit temperature was satisfactory using the four-window
temperature indicator strip included with the cartridge boxes. From each shipment of cartridges,
analyze multiple levels of i-STAT ACT Controls using any verified Analyzer. Instructions for the use of
these controls are found in the i-STAT System Manual.
For additional information on Quality Control of the i-STAT System, refer to the Quality Control
section in the i-STAT System Manual.

Specimen Collection and Preparation

The i-STAT CeliteACT test can be performed using venous or arterial samples.

Venipunctures and Arterial Punctures

• Collection technique resulting in good blood flow must be used.
• The sample for testing should be drawn into a plastic collection device (either a plastic
syringe or plastic evacuated tube).
• The collection device cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate.
• The collection device cannot contain clot activators or serum separators.
• The sample should be immediately dispensed into the sample well of a cartridge.
• If a second measurement is required, a fresh sample must be obtained.
Note: Some experts recommend drawing and discarding a sample of at least 1 mL prior to drawing sample for
coagulation testing.5

In-dwelling line
• Fluid drip through the line must be discontinued.
• Withdraw 2 mL of blood into a syringe and discard it.
• Withdraw the sample for testing into a fresh plastic syringe.
• The collection syringe cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate.
• The sample should be immediately dispensed into the sample well of a cartridge.
• If a second measurement is needed, draw a fresh sample.

Rev. Date: 04/16/04 Art: 714185-01D CELITE ACT

Extracorporeal line
• Flush the extracorporeal blood access line by withdrawing 5 mL of blood into a syringe and
discard the syringe.
• Withdraw the sample for testing into a fresh plastic syringe.
• The collection syringe cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate.
• The sample should be immediately dispensed into the sample well of a cartridge.
• If a second measurement is needed, draw a fresh sample.

References
1. Hattersly, P. Activated coagulation time of whole blood. Journal of the American Medical Association
136:436-440, 1966.
2. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A (ISBN 1-56238-283-7). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087, 1995.
3. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
4. Wang, JS; Lin, CY; Hung, WT; Thisted, RA; Carp, RB. In vitro effects of aprotinin on activated clotting
time measured with different activators. Journal of Thoracic Cardiovascular Surgery 104(4):1135-40,
1992.
5. Corriveau, Donna: Fritsma, George (ed.): Hemostasis and Thrombosis in the Clinical Laboratory. Ed,
J.B. Lippinncott Company, Philadelphia, 1988, pp 70-71.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ. Celite is a registered trademark of Celite Corporation, Santa Barbara, CA,
for its diatomaceous earth products. Hemochron is a registered trademark of International Technidyne Corporation, Edison, NJ

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 714185-01D Rev. Date: 04/16/04

 KAOLIN ACTIVATED CLOTTING TIME/
(KAOLINACT)

The i-STAT® Kaolin Activated Clotting Time test, KaolinACT, is a measure of the time required for
complete activation of the coagulation cascade.1
In traditional ACT tests, coagulation is initiated by mixing a whole blood sample with a particulate
activator, and complete activation is indicated when extensive or localized clots form as activated
thrombin converts fibrinogen to fibrin. These clots are mechanically detected.
The i-STAT KaolinACT test is similar to traditional ACT tests except that the endpoint is indicated by
the conversion of a thrombin substrate other than fibrinogen and an electrochemical sensor is used to
indicate the event of this conversion. The substrate used in the electrogenic assay has an amide linkage
that mimics the thrombin-cleaved amide linkage in fibrinogen.
The substrate is H-D-phenylalanyl-pipecolyl-arginine-p-amino-p-methoxydiphenylamine which has the
structure:
Phenylalanine - Pipecolic acid - Arginine -- NH - C6H4 - NH - C6H4 - OCH3
Thrombin cleaves the amide bond at the carboxy- terminus of the arginine residue (denoted by the
two dashes) because the bond structurally resembles the thrombin-cleaved amide linkage in fibrinogen.
The product of the thrombin-substrate reaction is the electrochemically inert tripeptide Phenylalanyl
- Pipecolyl - Arginine and the electroactive compound NH3+ - C6H4 - NH - C6H4 - OCH3. The
formation of the electroactive compound is detected amperometrically, and the time of detection is
measured in seconds. The test reports the Activated Clotting Time (ACT) in seconds.
The i-STAT KaolinACT test is calibrated to match the Hemochron Celite FTCA510 using prewarmed
reagent tubes. However, users of the i-STAT®1 analyzer may choose to customize their individual
i-STAT locations to report ACT results as calibrated against the Hemochron Celite ACT using non-
prewarmed (ambient temperature) tubes. This customization affects the Patient path only, and will not
be applied to the Control or the Proficiency Testing pathway.
The customization in effect (prewarm or non-prewarm calibration mode) is identified on the analyzer
screen as PREWRM or NONWRM, respectively. Please note that different locations within a given
hospital may utilize different customization profiles. Prior to patient sample testing, ensure the
appropriate calibration mode is employed. For a comprehensive discussion of this customization
feature, please see the Technical Bulletin entitled “ACT Test Result Calibration Options: PREWARMED
vs. NON-PREWARMED Result Calibration Modes for the i-STAT®1 Analyzer”.
If results appear inconsistent with the clinical assessment, the patient sample should be re-tested using
another cartridge.

Intended Use
The i-STAT Kaolin Activated Clotting Time (KaolinACT) test is an in vitro diagnostic test that uses fresh
whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular
surgery.
The test is to be used with the i-STAT Portable Clinical Analyzer and the i-STAT 1 Analyzer, but not the
Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM).

Art: 715878-01C Rev. Date: 07/12/04

 Contents
Each i-STAT KaolinACT cartridge provides a sample collection chamber, sensors to detect the coagulation
endpoint, and dry reagents necessary to initiate and allow coagulation. Stabilizers and reagents are
coated on a section of the sensor channel and include the following reactive ingredients:

Reactive Ingredient
Kaolin
Thrombin Substrate

Metrological Traceability
The i-STAT System test for Kaolin Activated Clotting Time measures the time interval required
for complete activation, by kaolin, of the coagulation cascade in arterial or venous whole blood
(dimension seconds) for in vitro monitoring of high-level heparin therapy. Presently, no international
conventional reference measurement procedure or international conventional calibrator for KaolinACT
is available. KaolinACT values assigned to i-STAT’s controls are traceable to i-STAT’s selected reference
measurement procedure, which employs Celite activated glass reagent tubes, an automated timer and
traditional viscometric clot detection and is run under specified temperature and sample conditions.
i-STAT System controls are validated for use only with the i-STAT System and assigned values may
not be commutable with other methods. Further information regarding metrological traceability is
available from i-STAT Corporation.

Expected Values
Test/Abbreviation Units Reportable Range Reference Range Reference Range
(PREWRM) (NONWRM)
Activated Clotting seconds 50 - 1000* 74 - 137 82- 152
Time/ACT

* The range from 77 - 1000 seconds (PREWRM mode) has been verified through method comparison studies.

Clinical Significance
The ACT is primarily used to monitor a patient’s state of anticoagulation due to heparin that
is administered during a medical or surgical procedure. It is commonly employed in cardiac
catheterization, Percutaneous Transluminal Coronary Angioplasty (PTCA), renal dialysis, hemodialysis,
and extra-corporeal circulation during bypass.

Performance Characteristics
The typical performance data summarized below was collected in health care facilities by health care
professionals trained in the use of the i-STAT System and comparative methods. All data uses the
PREWRM calibration, unless otherwise noted.
Precision data were collected at i-STAT and during clinical trials following a protocol recommended
by i-STAT and using plasma control material. Similar results can be expected in future performance
studies provided the same experimental design and data analysis procedures are followed.

Plasma Control n Mean SD %CV

Level 1 119 169 seconds 4 seconds 2.0
Level 2 113 409 seconds 21 seconds 5.2

KAOLIN ACT Art: 715878-01C Rev. Date: 07/12/04

Method comparison data were collected using a modification of the NCCLS guideline EP9-A2. Venous
or arterial blood samples were collected in plastic syringes and analyzed in duplicate on the i-STAT
System and in duplicate using the comparative methods. All samples were analyzed immediately
upon collection. The patient populations in the studies were those in which ACT is routinely used and
included both aprotinin and non-aprotinin receiving patients. All were undergoing cardiac surgery.
Sample types included baseline, heparin-treated, and heparin-reversed samples.
Deming regression analysis3 was performed on the first replicate of each sample. In the method
comparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates of the
imprecision based on the duplicates of the comparative and i-STAT methods respectively, Sy.x is the
standard error of the estimate, and r is the correlation coefficient.
Method comparisons will vary from site to site due to differences in the sample handling, reagent and
instrument systems in use, and other site-specific variables.

Hemochron FTK-ACT
CVOR Site 1 Site 2 Site 3
n 104 118 106
Sxx 9.1% 6.8% 7.6%
Syy 3.6% 4.0% 3.6%
Slope 0.96 1.05 0.96
Intercept -12 -38 -39
Xmin 68 111 81
Xmax 1286 1310 1102
r 0.906 0.940 0.971

Rev. Date: 07/12/04 Art: 715878-01C KAOLIN ACT

 Factors Affecting Results*
The i-STAT KaolinACT test is not significantly prolonged in the presence of aprotinin (Trasylol).
*It is possible that other interfering substances may be encountered. These results are representative and your results may differ somewhat due
to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Heparin sensitivity was demonstrated using whole blood samples to which varying concentrations of
heparin were added in vitro.
The following three graphs below each indicate the response of a different donor with respect to
heparin concentration:

KAOLIN ACT Art: 715878-01C Rev. Date: 07/12/04

Rev. Date: 07/12/04 Art: 715878-01C KAOLIN ACT
 The following two graphs indicate the response of the same three donors with respect to the ACT result
on the Medtronic HR-ACT and the Hemochron Kaolin FTK-ACT.

KAOLIN ACT Art: 715878-01C Rev. Date: 07/12/04

Test Limitations
The i-STAT KaolinACT test is to be used with fresh venous or arterial whole blood samples. The presence
of exogenously added heparin, citrate, oxalate, or EDTA will interfere with test results. Poor technique
in sample collection may also compromise the results. Samples drawn from insufficiently flushed
catheters or from traumatic venipunctures may be contaminated with interfering substances. Samples
should be collected into plastic syringes or tubes. Collection into glass may prematurely activate
coagulation resulting in accelerated clotting times.
The analyzer should remain on a level surface with the display facing up during testing. If the analyzer
is not level, the ACT result may be affected by more than 10%.
Hemodilution may affect test results.
Platelet dysfunction, factor deficiencies, dysprothrombinemias, pharmacological compounds, and
other coagulopathies may affect the results of this test.
The i-STAT ACT test is not affected by fibrinogen concentration in the range from 100 - 500 mg/dL, or
sample temperature from 15 - 37ºC.

Storage Instructions
Cartridges in sealed pouches are stable through the expiration date when stored refrigerated at 2 to 8°C
and for two weeks at room temperature (18 - 30°C).
Upon removal from refrigeration, a box of 25 cartridges requires one hour equilibration at room
temperature before use. Individual cartridges require five minutes equilibration. A cartridge should be
used immediately after it is removed from the pouch.

Quality Control
On each day the analyzers are in use, the performance of all Analyzers in the i-STAT System on site
should be verified using the i-STAT Electronic Simulator.
On receipt of new cartridges, verify that the transit temperature was satisfactory using the four-window
temperature indicator strip included with the cartridge boxes. From each shipment of cartridges,
analyze multiple levels of i-STAT ACT Controls using any verified Analyzer. Instructions for the use of
these controls are found in the i-STAT System Manual.
For additional information on Quality Control of the i-STAT System, refer to the Quality Control
section in the i-STAT System Manual.

Specimen Collection and Preparation

The i-STAT KaolinACT test can be performed using venous or arterial samples.

Venipunctures and Arterial Punctures

• Collection technique resulting in good blood flow must be used.
• The sample for testing should be drawn into a plastic collection device (either a plastic
syringe or plastic evacuated tube).
• The collection device cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate.
• The collection device cannot contain clot activators or serum separators.
• The sample should be immediately dispensed into the sample well of a cartridge.
• If a second measurement is required, a fresh sample must be obtained.
Note: Some experts recommend drawing and discarding a sample of at least 1 mL prior to drawing sample for
coagulation testing.4

Rev. Date: 07/12/04 Art: 715878-01C KAOLIN ACT

In-dwelling line
• Fluid drip through the line must be discontinued.
• Withdraw 2 mL of blood into a syringe and discard it.
• Withdraw the sample for testing into a fresh plastic syringe.
• The collection syringe cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate.
• The sample should be immediately dispensed into the sample well of a cartridge.
• If a second measurement is needed, draw a fresh sample.

Extracorporeal line
• Flush the extracorporeal blood access line by withdrawing 5 mL of blood into a syringe and
discard the syringe.
• Withdraw the sample for testing into a fresh plastic syringe.
• The collection syringe cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate.
• The sample should be immediately dispensed into the sample well of a cartridge.
• If a second measurement is needed, draw a fresh sample.

References
1. Hattersly, P. Activated coagulation time of whole blood. Journal of the American Medical Association
136:436-440, 1966.
2. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS
document EP9-A (ISBN 1-56238-283-7). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087, 1995.
3. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
4. Corriveau, Donna: Fritsma, George (ed.): Hemostasis and Thrombosis in the Clinical Laboratory. Ed,
J.B. Lippinncott Company, Philadelphia, 1988, pp 70-71.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ. Celite is a registered trademark of Celite Corporation, Santa Barbara, CA,
for its diatomaceous earth products. Hemochron is a registered trademark of International Technidyne Corporation, Edison, NJ

Manufacturer: Emergo Europe

i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 715878-01C Rev. Date: 07/12/04

 PROTHROMBIN TIME/
(PT/INR)
The i-STAT® PT/INR test is a whole blood determination of the prothrombin time used for monitoring
oral anticoagulant (warfarin) therapy. The test determines the time required for complete activation of
the extrinsic pathway of the coagulation cascade when initiated (activated) with a thromboplastin.
In a prothrombin time test, coagulation is initiated by mixing the sample with tissue thromboplastin.
In traditional prothrombin time tests, complete activation is indicated when activated thrombin
converts fibrinogen to fibrin and extensive or localized clots are detected mechanically or optically.
The i-STAT PT/INR test is similar except that the endpoint is indicated by the conversion of a thrombin
substrate other than fibrinogen. An electrochemical sensor is used to detect this conversion.
The added thrombin substrate is H-D-phenylalanyl-pipecolyl-arginine-p-amino-p methoxydiphenylamine,
which has the structure:
Phenylalanine - Pipecolic acid - Arginine -- NH - C6H4 - NH - C6H4 - OCH3

Thrombin cleaves the amide bond at the carboxy terminus of the arginine residue (denoted by the two
dashes) because the bond structurally resembles the thrombin-cleaved amide linkage in fibrinogen.
The product of the thrombin-substrate reaction is the electrochemically inert tripeptide Phenylalanyl
- Pipecolyl - Arginine and the electroactive compound NH3+ - C6H4 - NH - C6H4 - OCH3. A
formation of the electroactive compound is detected amperometrically and the time of detection is
measured.
The PT/INR test result is reported as an International Normalized Ratio (INR) and, optionally, in
seconds. The INR is the recommended method of result reporting for monitoring of oral anticoagulant
therapy1. A Mean Normal i-STAT prothrombin time (sec) and an ISI are determined following the
WHO recommendations at a CAP-accredited facility. INR results are calculated using the following
equation:

INR = Patient i-STAT prothrombin time (sec)  ISI

Mean Normal i-STAT prothrombin time (sec)

The optionally displayed units of seconds reflect traditional plasma PT times. The reported time is
derived from the PT/INR result and the equation below using an ISI of 1.05 and a typical Mean Normal
Plasma PT time of 12.0 seconds.

INR = Patient Plasma prothrombin time (sec)  ISI

Mean Normal Plasma prothrombin time (sec)

If results appear inconsistent with the clinical assessment, the patient sample should be recollected and
retested using another cartridge.

Intended Use
The i-STAT PT/INR is an in vitro diagnostic test intended for quantitative prothrombin time testing for the
monitoring of oral anticoagulation therapy using fresh capillary or venous whole blood samples. The i-
STAT PT/INR test is not intended for evaluating individual factor deficiencies. The PT/INR is to be used
with the i-STAT Portable Clinical Analyzer and i-STAT 1 Analyzer, but will not run on the Philips Medical
Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the

Art: 715236-01C Rev. Date: 04/16/04

 PT/INR test is to be used by trained and certified health care professionals in accordance with a facility’s
policies and procedures.

Contents
Each i-STAT PT/INR cartridge provides a sample collection chamber, sensors to detect the coagulation
endpoint and dry reagents necessary to initiate and allow coagulation. Inert matrix components and
reagents are coated on a section of the sensor channel and include the following reactive ingredients:

Reactive Ingredient Biological Source

Recombinant Tissue Human
Thromboplastin
Heparinase I Flavobacterium heparinum
Thrombin Substrate N/A

Metrological Traceability
The i-STAT System test for Prothrombin Time (PT/INR) measures the International Normalized
Ratio (dimensionless) expressing the relative time interval required for complete activation, by
thromboplastin, of the coagulation cascade in capillary or venous whole blood for in vitro monitoring
of oral anticoagulant (warfarin) therapy. PT/INR values assigned to i-STAT’s controls are traceable to
the World Health Organization (WHO) international reference measurement procedures and the WHO
human recombinant thromboplastin International Reference Preparation2. i-STAT System controls are
validated for use only with the i-STAT System and assigned values may not be commutable with other
methods. Further information regarding metrological traceability is available from i-STAT Corporation.

Expected Values

Test/Abbreviation Units Verified Clinical Range

Prothrombin Time/ (PT/INR) INR 0.9 - 6.0*

*The performance characteristics of the i-STAT PT/INR measurement have not been established at INRs above 6.0.

Performance Characteristics
The typical performance data summarized below were collected in healthcare facilities by healthcare
professionals trained in the use of the i-STAT System and comparative methods.

Imprecision
Typical imprecision data for venous whole blood samples are presented in the table below for sample
duplicates collected at two clinical sites. Typical imprecision data for capillary whole blood samples are
presented for sample duplicates collected at one clinical site using a single capillary stick.

Statistic Site 1 (venous) Site 2 (venous) Site 3 (capillary )

n 181 102 33
Mean (INR) 2.6 2.4 2.5
%CV 4.7% 4.0% 4.6%

Typical imprecision data for lyophilized plasma material are presented below for studies performed at
an i-STAT Corporation facility and during clinical trials.

Plasma Control Mean SD %CV

Level 1 1.1 (INR) 0.05 4.5%
Level 2 2.5 (INR) 0.17 6.9%

Prothrombin Time Art: 715236-01C Rev. Date: 04/16/04

Reference Interval
In a study to determine a reference interval for PT/INR, venous samples from healthy volunteers were
collected in plastic tubes, and whole blood was analyzed with one lot of cartridges on the i-STAT
System. Capillary samples were obtained from the same volunteers using Softclick Pro (setting of 3) and
analyzed on the same cartridge lot. Reference intervals for INR in venous and capillary samples were
determined according to the NCCLS Guideline C28-A2.3 The data are summarized in the table below:

Statistic Venous whole blood Capillary whole blood

n 120 119
Mean (INR) 1.0 1.0
SD 0.1 0.1
Reference Range (INR) 0.8 - 1.2 0.8 - 1.2

Due to the many variables that may affect PT/INR results, each laboratory should establish its own
reference interval.

Method Comparison
Method comparison data were collected at three clinical sites using a protocol in accordance with the
NCCLS Guideline EP9-A.4 Venous samples from outpatients undergoing routine oral anticoagulation
therapy were collected in plastic tubes and analyzed in duplicate on 3 lots of cartridges on the i-STAT
System; plasma from tubes containing a citrate anticoagulant were analyzed in duplicate on the
comparative instruments using Dade® Innovin® reagent.
Deming regression analysis5 was performed on the first replicate of each sample. In the method
comparison table below, n is the number of specimens in the data set, Sy.x is the standard error of the
estimate, and r is the correlation coefficient.
Method comparisons will vary from site to site due to differences in the sample handling, reagent and
instrument systems in use, and other site-specific variables. A correlation study should be performed to
establish the differences between the i-STAT PT/INR measurement and other methods used.

i-STAT vs. Electra® 700

i-STAT vs. Behring BCS® i-STAT vs. STA Compact® and
Statistic and Dade® Innovin®
and Dade® Innovin® reagent Dade® Innovin® reagent
reagent
n 183 180 177
Mean (INR) 2.3 2.3 2.5
Range (INR) 1.0 – 3.9 1.0 – 4.3 1.0 – 4.6
Sx (INR) 0.729 0.777 0.779
Slope 0.922 1.013 0.914
Intercept (INR) 0.402 0.012 0.054
r 0.898 0.943 0.948
Sy.x 0.322 0.272 0.191

Rev. Date: 04/16/04 Art: 715236-01C Prothrombin Time

Prothrombin Time Art: 715236-01C Rev. Date: 04/16/04
Data is presented below from one clinical site comparing data from capillary samples to data from
venous samples analyzed on the i-STAT System.

Statistic Capillary vs. Venous

n 39
Mean (INR) 2.4
Range (INR) 1.3 – 5.4
Sx (INR) 0.960
Slope 1.049
Intercept (INR) -0.098
Sy.x 0.128
r 0.978

Rev. Date: 04/16/04 Art: 715236-01C Prothrombin Time

 Performance Above the Therapeutic Range
Data are presented from multiple sites to demonstrate the performance at PT/INR levels above the
therapeutic range (greater than an INR of 4.0 on the comparative instrument). Results from these
sites are presented in the correlation graph below. The comparative method at all sites used a high-
sensitivity (ISI approximately 1.0) recombinant (Dade® Innovin®) reagent.

Prothrombin Time Art: 715236-01C Rev. Date: 04/16/04

Factors Affecting Results
• The presence of exogenously added heparin, citrate, oxalate, or EDTA from blood collection
devices will interfere with test results.
• Poor technique in sample collection may compromise the results. (See Specimen Collection and
Preparation below.)
• Glass syringes or tubes may prematurely activate coagulation, resulting in accelerated clotting
times and lower INRs.
• The i-STAT PT/INR test is insensitive to fibrinogen concentration between 70 and 541 mg/dL.
• The i-STAT PT/INR test is insensitive to heparin up to 1.0 U/mL.
• Hematocrits in the range of 24 – 54% PCV have been demonstrated not to affect results.
• PT/INR results may be affected by commonly administered drugs.

Test Limitations
• The analyzer must remain on a level, vibration free surface with the display facing up during
testing.
• Venous samples must be collected into plastic syringes or tubes.

Storage Instructions
Cartridges in sealed pouches are stable through the expiration date when stored refrigerated at 2 to 8°C
and for two weeks at room temperature (18 - 30°C).
Upon removal from refrigeration, a box of 24 cartridges requires one hour equilibration at room
temperature before use. Individual cartridges require five minutes equilibration. A cartridge should be
used immediately after it is removed from the pouch.

Quality Control
On a daily basis, the performance of all analyzers in the i-STAT System on site should be verified using
the i-STAT Electronic Simulator.
On receipt of new cartridges, verify that the transit temperatures were satisfactory using the four-window
temperature indicator strip included with the cartridge boxes. From each shipment of cartridges,
analyze multiple levels of i-STAT PT/INR Controls using any verified analyzer. These controls should
also be used to verify cartridge performance when storage conditions are in question. Instructions for
the use of these controls is available with the i-STAT System Manual.
For additional information on Quality Control of the i-STAT System, refer to the “Quality Control”
section in the i-STAT and i-STAT 1 System Manuals.

Specimen Collection and Preparation

Caution: The i-STAT PT/INR cartridge is designed to accept a sample between 20 and 45 microliters.
A single drop of blood from either a finger puncture or as formed at the tip of a syringe
will typically be within this range. If a larger volume is delivered to the sample well, use
caution when closing the cartridge as excess blood may be expelled from the cartridge.
The i-STAT PT/INR test can be performed using capillary or venous samples.

Skin Punctures
1. Remove cartridge from foil pouch and place the cartridge on a flat surface.
2. Prepare lancet device and set aside until needed.
3. Clean and prepare the finger to be sampled. Allow finger to dry thoroughly before sampling.
4. Prick the bottom side of the fingertip with the lancet device.
5. Gently squeeze the finger, developing a hanging drop of blood and perform the test with the
first sample of blood. Avoid strong repetitive pressure (“milking”) as it may cause hemolysis or tissue

Rev. Date: 04/16/04 Art: 715236-01C Prothrombin Time

 fluid contamination of the specimen.
6. Touch the drop of blood against the bottom of the sample well. Once in contact with the
sample well, the blood will be drawn into the cartridge.
7. Apply sample until it reaches the fill mark indicated on the cartridge.
8. Fold the sample closure over the sample well.
9. Press the rounded end of the closure until it snaps into place.
Note: To further simplify the sample application into the test cartridge, it is possible to bring the
cartridge to the finger for easier application. Do ensure that the instrument remains on a flat
vibration-free surface for testing.

Venipunctures
• Collection technique resulting in good blood flow must be used.
• The sample for testing should be drawn into a plastic collection device (either a plastic syringe
or plastic evacuated tube).
• The collection device cannot contain anticoagulants such as heparin, EDTA, oxalate, or citrate.
• The collection device cannot contain clot activators or serum separators.
• The sample should be immediately dispensed into the sample well of a cartridge. A drop of
blood should be touched against the bottom of the sample well. Once in contact with the
sample well, the blood will be drawn into the cartridge.
• If a second measurement is required, a fresh sample should be obtained.
Note: Some experts recommend drawing and discarding a (venous) sample of at least 1.0 mL prior to
drawing sample for coagulation testing.6

Prothrombin Time Art: 715236-01C Rev. Date: 04/16/04

References
1. Kirkwood TBL. Calibration of Reference Thromboplastins and Standardisation of the
Prothrombin Time Ratio. Thrombosis Haemostasis, 49 (3) 238-244, 1983.
2. L. Poller, The Prothrombin Time (Synonymous with thromboplastin time or Quick test), World
Health Organization, Geneva, WHO/LAB/98.3, 1998.
3. NCCLS. How to Define and Determine Reference Intervals in the Clinical Laboratory;
Approved Guideline---Second Edition. NCCLS document C28-A2 (ISBN 1-56238-406-6).
NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2000.
4. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline.
NCCLS document EP9-A (ISBN 1-56238-283-7). NCCLS, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087, 1995.
5. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
6. Corriveau, Donna: Fritsma, George (ed.): Hemostasis and Thrombosis in the Clinical
Laboratory. Ed, J.B. Lippinncott Company, Philadelphia, 1988, pp 70-71.
7. NCCLS. Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin
Puncture; Approved Standard—Fourth Edition. NCCLS document H4-A4 [ISBN 1-56238-382-
5]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 1999.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ

Dade Innovin, and BCS are registered trademarks of Dade Behring Inc., Deerfield, IL
STA Compact is a registered trademark of Diagnostica Stago, Cedex, France
Electra is a registered trademark of Instrumentation Laboratory, Lexington, MA

Rev. Date: 04/16/04 Art: 715236-01C Prothrombin Time

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 715236-01C Rev. Date: 04/16/04

 CARDIAC TROPONIN I/
(CTNI)
Intended Use
The i-STAT cTnI test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI)
in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the
diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary
syndromes with respect to their relative risk of mortality.

The cartridge is to be used with the i-STAT®1 Analyzer bearing the symbol, but not with the i-STAT®
Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis
Module (BAM). As part of the i-STAT System, the cTnI test is to be used by trained health care professionals in
accordance with a facility’s policies and procedures.

Method Explanation
The i-STAT cTnI test cartridge uses a two-site enzyme-linked immunosorbant assay (ELISA) method. Antibodies
specific for human cardiac troponin I (cTnI) are located on an electrochemical sensor fabricated on a silicon
chip. Also deposited in another location on the sensor silicon chip is an antibody/alkaline phosphatase enzyme
conjugate specific to a separate portion of the cTnI molecule. The whole blood or plasma sample is brought
into contact with the sensors allowing the enzyme conjugate to dissolve into the sample. The cTnI within the
sample becomes labeled with alkaline phosphatase and is captured onto the surface of the electrochemical sensor
during an incubation period of approximately seven minutes. The sample, as well as excess enzyme conjugate, is
washed off the sensors. Within the wash fluid is a substrate for the alkaline phosphatase enzyme. The enzyme
bound to the antibody/antigen/antibody sandwich cleaves the substrate releasing an electrochemically detectable
product. The electrochemical (amperometric) sensor measures this enzyme product which is proportional to the
concentration of cTnI within the sample.

Contents
Each i-STAT cTnI cartridge provides a sample inlet, sensors to detect the cTnI as described above, and all the
necessary reagents needed to perform the test. The cartridge contains a buffer and preservatives. A list of reactive
ingredients is indicated below:

Reactive Ingredient Biological Source

Antibody/Alkaline Caprine IgG: Bovine
Phosphatase Conjugate Intestine
IgG Caprine IgG: Murine IgG
Sodium Aminophenyl N/A
Phosphate
Heparin Porcine Intestine

Metrological Traceability
The i-STAT System test for cardiac troponin-I (cTnI) measures cardiac troponin-I amount-of-substance
concentration in plasma or the plasma fraction of whole blood (dimension ng mL-1) for in vitro diagnostic use.
Cardiac troponin-I values assigned to i-STAT’s controls and calibration verification materials are traceable to
i-STAT’s working calibrator prepared from human cardiac troponin-ITC complex (Hy-Test Ltd., Turku, Finland,
catalogue #8T62). i-STAT System controls and calibration verification materials are validated for use only with
the i-STAT System and assigned values may not be commutable with other methods. Further information
regarding metrological traceability is available from i-STAT Corporation.

Art: 715595-01C Rev. Date: 01/25/05

 Reportable Range
The i-STAT cTnI test will report 0.00 to 50.00 ng/mL (µg/L). Samples above the reportable range will yield “>50.00
ng/mL” on the analyzer display screen. However, the performance characteristics of the i-STAT cTnI measurement
have not been established for cTnI values above 35.00 ng/mL (µg/L).

Reference Range
Whole blood and plasma samples from 162 apparently healthy donors were assayed in duplicate using three
different lots of i-STAT cTnI cartridges. The 0 to 97.5% range of results spanned 0.00 ng/mL (µg/L) to 0.03 ng/
mL (µg/L). The 0 to 99% range of results spanned 0.00 ng/mL (µg/L) to 0.08 ng/mL (µg/L).
Note: Each facility should establish its own reference range using the i-STAT cTnI assay.

Clinical Significance
Biochemical cardiac markers, including cTnI, are useful for both the diagnosis of myocardial infarction and the
risk stratification that can help guide the choice of therapeutic options.

For optimal diagnostic usefulness, a cardiac marker should be specific for cardiac tissue, should be rapidly
released into the bloodstream with a direct proportional relationship between the extent of myocardial injury
and the measured level of the marker, and should persist in blood for a sufficient length of time to provide
a convenient diagnostic time window.1 The cardiac-specific troponins, troponin I (cTnI) and troponin T
(cTnT) are considered the biochemical markers of choice in the evaluation of acute coronary syndromes (ACS)
including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina.
Since cTnI is not generally detected in the blood of healthy persons, any level of cTnI above the upper limit
of the reference range defined in a normal healthy population should be considered indicative of myocardial
necrosis.1 Each institution should establish its own reference range for its patient population, and this range
should be used to determine an appropriate limit indicative of acute myocardial infarction.

Elevated levels of cardiac-specific troponins convey prognostic information beyond that supplied by the patient’s
clinical signs and symptoms, the ECG at presentation, and the pre-discharge exercise test. 1 Antman, et al.,
reported that patients with elevated levels of cTnI had a statistically significant increase in mortality (p<0.001)
when compared to patients without cTnI elevations.2 Also, the study revealed that there is a quantitative
relationship between the cTnI level measured and the risk of death in ACS patients (p<0.001). Other studies
have shown increases in other non-fatal cardiac events such as non-fatal MI, congestive heart failure, and urgent
revascularization with increasing levels of cTnI.3,4,5

In addition, the ability of cTnI to be measured at the low-end of the concentration range allows therapeutic
intervention to be considered at any elevation above the normal range. Patients that present with no ST-elevation
on their ECG but who have even slight elevation in cTnI or cTnT may receive a greater treatment benefit from
certain drugs such as GP IIb/IIIa inhibitors or low molecular weight heparins.6,7,8

Other conditions like blunt trauma or myocarditis that are not secondary to ischemic coronary artery disease can
also lead to myocardial injury and have the potential to cause elevations in the blood concentrations of cTnI.
These conditions should be considered when interpreting results, and the cTnI level should be used in conjunction
with clinical symptoms, signs, and ECG changes.1

Performance Characteristics
Precision data were collected in multiple sites as follows: Duplicates of each control were tested daily for a period
of 20 days, resulting in a total of 40 replicates. The average statistics are presented below.

Method comparison data were collected using NCCLS guideline EP9-A.9 Venous blood samples were collected
in heparinized evacuated tubes and analyzed in duplicate on the i-STAT System. A portion of the specimen was
centrifuged and the separated plasma was analyzed in duplicate on the comparative method within 1 hour of
collection.

Deming regression analysis10 was performed on the first replicate of each sample. In the method comparison
table, n is the number of specimens in the first data set, Sxx and Syy refer to estimates of imprecision based on the
duplicates of the comparative and the i-STAT methods respectively. Sy.x is the standard error of the estimate, and r
is the correlation coefficient.*

Cardiac Troponin I Art: 715595-01C Rev. Date: 01/25/05

Method comparisons will vary from site to site due to differences in sample handling, comparative method
calibration and other site specific variables.

Interference studies were based on NCCLS guideline EP7.11

*The usual warning relating to the use of regression analysis is summarized here as a reminder. For any analyte, “if the data is a narrow range,
the estimate of the regression parameters are relatively imprecise and may be biased. Therefore, predictions made from estimates may be
invalid”.9 The correlation coefficient, r, can be used as a guide to assess the adequacy of the comparative method range in overcoming the
problem. As a guide, the range of data can be considered adequate if r>0.975.

Precision Data (ng/mL)

Aqueous Control Mean SD %CV
Level 1 0.53 0.04 7.8
Level 2 2.17 0.18 8.5
Level 3 31.82 2.42 7.6

Method Comparison (ng/mL)

Dade Behring
Stratus® CS
n 189
Sxx 0.28
Syy 0.31
Slope 0.883
Int’t 0.029
Sy.x 1.40
Xmin 0.00
Xmax 46.27
r 0.975

Analytical and Functional Sensitivities

The analytical sensitivity of the cTnI method is 0.02 ng/mL, which is the lowest cTnI level that can be
distinguished from zero. The analytical sensitivity is defined as the concentration at two standard deviations from
a sample at 0.00 ng/mL.

Another characteristic of an analytical measurement is the functional sensitivity, which is defined as the cTnI level
at which the test method displays a particular percent coefficient of variation (%CV). Estimates of the 20% and
10% functional sensitivity for the cTnI method were determined from whole blood measurements. The 20% and
10% functional sensitivities for the cTnI method are 0.07 ng/mL and 0.10 ng/mL, respectively (see graph below).

Rev. Date: 01/25/05 Art: 715595-01C Cardiac Troponin I

 Analytical Specificity
The cTnI method is specific for cardiac troponin I. The following muscle proteins were tested and found to have
an insignificant effect on the measured cTnI.

Crossreactant Concentration Percent Crossreactivity

Troponin C (cardiac) 1000 ng/mL <0.002%
Troponin T (cardiac) 1000 ng/mL 0.65%
Troponin I (skeletal) 1000 ng/mL <0.002%
Troponin T (skeletal) 1000 ng/mL <0.002%

Recovery
The dilution linearity of the i-STAT cTnI test was investigated using heparinized whole blood and plasma samples
derived from 3 separate donors. For each donor, the original cTnI negative sample and a cTnI spiked sample were
prepared. This process yielded three cTnI positive whole blood samples that were then assayed in duplicate for
each of three separate i-STAT cTnI cartridge lots. These whole blood samples were then diluted using an equal
mass of the original unspiked whole blood and assayed in duplicate. From this whole blood data, the cTnI
recovery was calculated.

The plasma derived from these three donors was combined in equal masses and all pairwise combinations. These
combinations were then assayed in duplicate for each of three separate i-STAT cTnI cartridge lots. The cTnI
recovery for each pair was calculated using the average of the 6 results. The % recoveries are listed in the Tables
below.

Whole blood
Sample Concentration Diluted Concentration % Recovery
A 2.05 1.04 101%
B 6.31 3.14 100%
C 27.04 14.05 104%

Plasma
Sample Concentration Diluted Concentration % Recovery
A 2.41 ----- -----
B 7.50 ----- -----
C 29.35 ----- -----
A+B ----- 4.69 95%
B+C ----- 18.90 103%
A+C ----- 16.89 106%

Cardiac Troponin I Art: 715595-01C Rev. Date: 01/25/05

Test Limitations
Partially clotted samples can result in elevated cTnI readings above the reference range, as well as quality
check code errors. To prevent this from occurring, upon drawing the whole blood sample into a heparized
collection tube, the sample should be inverted gently at least 10 times to insure even dissolution of the heparin
anticoagulant.

Grossly hemolyzed samples can cause a decreased alkaline phosphatase activity, resulting in decreased detection of
cTnI, increased assay backgrounds, and/or quality check codes.

Hematocrits in the range of 0-65 % PCV have been demonstrated not to affect results. Samples with hematocrit
levels above this range have demonstrated increases in the test imprecision and quality check codes.

The analyzer must remain on a level surface with the display facing up during testing. Motion of the analyzer
during testing can increase the frequency of suppressed results or quality check codes.

Storage Instructions
Please see the “Shelf Life” and “Preparation for Use” sections on page 1 of the Cartridge and Test Information
section of the i-STAT 1 System Manual.

Quality Control
On a daily basis, the performance of all Analyzers in the i-STAT System on site should be verified using the i-STAT
Electronic Simulator.

On receipt of new cartridges, verify that the transit temperatures were satisfactory using the four-window
temperature indicator strip included with the cartridge boxes. From each shipment of cartridges, analyze multiple
levels of i-STAT Cardiac Marker Controls using any verified Analyzer. These controls should also be used to verify
cartridge performance when storage conditions are in question.

For additional information on Quality Control of the i-STAT System, refer to the “Quality Control” section of the
i-STAT 1 System Manual.

Specimen Collection and Preparation.

i-STAT cTnI cartridges require the use of either:

1. heparinized whole blood or plasma samples collected in syringes or evacuated tubes containing lithium or
sodium heparin, or
2. non-heparinized whole blood samples tested within one minute of drawing from a patient into a plastic
syringe or plastic evacuated tube containing no additives. The cartridge contains sufficient reagent to
heparinize the freshly drawn sample.
The use of whole blood or plasma samples containing other anticoagulants such as EDTA, oxalate, and
citrate will cause deactivation of the alkaline phosphatase, resulting in decreased cTnI readings. Capillary
tubes and direct skin punctures (e.g. fingersticks) should not be used with the cTnI cartridge.

The i-STAT cTnI cartridge requires a minimum sample volume of 16 µL of sample to fill. Excess amounts beyond
this requirement will not impair the results. However, excess blood or plasma will be present at the inlet of the
cartridge and caution should be observed in handling the cartridge to minimize biohazard exposure.

Samples should not be used unless the blood collection tube is filled at least half full.

For best results, samples must be mixed well before transfer to a cartridge. Immediately after filling the cartridge,
the sample port should be closed and the cartridge inserted into the analyzer.

Rev. Date: 01/25/05 Art: 715595-01C Cardiac Troponin I

 Interference Testing
The following substances were found to have no significant effect (less than 10%) on the cTnI method, when
added to a plasma pool containing approximately 2 ng/mL of cardiac troponin I, at the concentrations indicated:

Test Level
Compound
(µmol/L unless otherwise indicated)
Acetaminophen 1660
Allopurinol 294
Ascorbic Acid 227
Acetyl Salicylic Acid 3330
Atenolol 37.6
Caffeine 308
Captopril 23
Chloramphenicol 155
Diclofenac 169
Digoxin 6.15
Dopamine 5.87
Enalaprilat 0.86
Erythromycin 81.6
Furosemide 181
Sodium Heparin* 36 U/mL
Ibuprofen 2425
Isosorbide dinitrate 0.636
Methyldopa 71
Nicotine 6.2
Nifedipine 1.156
Phenytoin 198
Propanolol 7.71
Salicylic Acid 4340
Theophylline 222
Verapamil 4.4
Warfarin 64.9

*Heparin at 90U/mL was found to decrease the cTnI level by approximately 20%.

Cardiac Troponin I Art: 715595-01C Rev. Date: 01/25/05

References
1. Braunwald, E, et al. ACC/AHA 2002 guideline update for the management of patients
with unstable angina and non-ST-segment elevation myocardial infarction: a report of
the American College of Cardiology/American Heart Association Task Force on Practice
Guidelines (Committee on the Management of Patients with Unstable Angina). 2002.
Available at: http://www.acc.org/clinical/guidelines/unstable/unstable.pdf.
2. Antman EM, Tanasijevic, MJ, Thompson B, et al. Cardiac-specific troponin I levels to predict
the risk of mortality in patients with acute coronary syndromes. NEJM 1996, 335(18): 1342-
1349.
3. Galvani M, Ottani F, Ferrini D, et al. Prognostic influence of elevated values of cardiac
troponin I in patients with unstable angina. Circulation 1997, 95: 2053-2059.
4. Morrow DA, Rifai N, Tanasijevic MJ, et al. Clinical efficacy of three assays for cardiac
troponin I for risk stratification in acute coronary syndromes: A thrombolysis in myocardial
infarction (TIMI) IIB substudy. Clin Chem 2000, 46(4): 453-460.
5. Sabatine MS, Morrow DA, de Lemos JA, et al. Multimarker approach to risk stratification
in non-ST-elevation acute coronary syndromes: Simultaneous assessment of troponin I, C-
reactive protein, and B-type natriuretic peptide. Circulation 2002, 105: 1760-1763.
6. Cannon CP, Weintraub WS, Demopoulos LA, et al. Comparison of early invasive and
conservative strategies in patients with unstable coronary syndromes treated with the
glycoprotein IIb/IIIa inhibitor tirofiban. NEJM 2001, 344(25): 1879-1887.
7. Morrow DA, Antman EM, Tanasijevic MJ, et al. Cardiac troponin I for stratification of early
outcomes and the efficacy of enoxaprin in unstable angina: A TIMI-IIB substudy. JACC 2000,
36: 1812-1817.
8. Hamm CW, Heeschen C, Goldmann B, et al. Benefit of abciximab in patients with refractory
unstable angina in relation to serum troponin T levels (CAPTURE Study Investigators). NEJM
1999, 340: 1623-1629.
9. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline
– Second Edition. NCCLS document EP9-A2 [ISBN 1-56238-472-4]. NCCLS, 940 West Valley
Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2002.
10. P.J. Cornbleet and N. Gochman, “Incorrect Least-Squares Regression Coefficients in Method-
Comparison Analysis,” Clinical Chemistry 25:3, 432 (1979).
11 NCCLS. Interference Testing in Clinical Chemistry; Approved Guideline. NCCLS document EP7-
A [ISBN 1-56238-480-5]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898, USA 2002.

Rev. Date: 01/25/05 Art: 715595-01C Cardiac Troponin I

Manufacturer: Emergo Europe
i-STAT Corporation P.O. Box 18510
104 Windsor Center Drive 2502 EM The Hague
East Windsor, NJ 08520 • USA The Netherlands
Tel: (609) 443-9300 Tel: (31)70 345 8570
Fax: (609) 443-9310 Fax: (31)70 346 7299

©2003 i-STAT Corporation. All rights reserved. Printed in USA.

Art: 715595-01C Rev. Date: 01/25/05

 TECHNICAL
BULLETIN

ANALYZER CODED MESSAGES

From the time it powers up until the time it powers down, the i-STAT® Analyzer performs numerous quality
checks. The failure of any quality check causes the analyzer to halt the test cycle and display a “cause”, an
“action” message, and a code.

The Cause This message describes the likely cause of the failed quality check. For example, when
Message: an overfilled cartridge is detected, the analyzer will display “Sample Positioned Beyond
Fill Mark”.

The Action This message indicates the appropriate action. For example, if it is likely the quality
Message: check will fail again the next time the analyzer is used, the instruction “Use Electronic
Simulator” will be displayed. If the problem is related to an operator or cartridge, the
instruction “Use Another Cartridge” will be displayed.

The Cause Code: This is a numeric code associated with the failed quality check. Since multiple codes can
be associated with a single cause message, this is essential information when contacting
i-STAT Technical Services or your local support organization for further assistance. The
codes are stored in the analyzer’s memory along with other test records and are transmit-
ted to the Central Data Station. The code list can be viewed and printed.

Codes 1-14 and 95 usually indicate a condition related to the environment or the state of the analyzer. These conditions
are usually benign and go away after the next cartridge or Electronic Simulator is inserted, or after the offending
condition is corrected.

CODE CAUSE/ACTION EXPLANATION

NUMBER MESSAGE ON DISPLAY

1 DE AD BATTE RIE S / Replace There is insufficient battery power to complete the testing
Batteries cycle. Replace the disposable lithium batteries in the analyzer or
recharge the rechargeable batteries.
If you are experiencing this code frequently and use disposable
batteries with the i-STAT 1 analyzer, you may want to consider
the rechargeable battery system available with the i-STAT 1
Analyzer.

2 Temperature Out of The analyzer is recording a temperature outside its operating

Range / Check Status range. Move the analyzer to an area within the operating
Page temperature of the test being performed and allow the analyzer
to come to the new room temperature. Check the analyzer’s
temperature reading on the Status Page.

Art: 714260-01C Rev. Date: 01/25/05

CODE CAUSE/ACTION EXPLANATION
NUMBER MESSAGE ON DISPLAY

3 NE W SOFTW ARE IN STALLE D This message appears on the Portable Clinical Analyzer after
/ Use Electronic new software has been installed or, in some cases, when a new
Simulator customization profile is received.

4, 8 Analyzer Interrupted / The analyzer has detected that the last test cycle was not
Use Another Cartridge completed. This can happen if the batteries were removed
or were making poor contact while a cartridge was still in the
analyzer. Batteries that are too short will not make proper
contact. Check that the batteries are inserted properly and
seated well in the analyzer; check the battery voltage on the
analyzer’s Status Page and replace batteries if low. NOTE:
Patient results displayed before this code are valid.

5, 6, 9 Analyzer Interrupted / The Portable Clinical Analyzer is unable to refresh the display.
Ready for Use This can happen if power is interrupted before the analyzer
powers itself down. Check that batteries are inserted properly
and seated well in the analyzer. Batteries that are too short will
not make proper contact. Check the battery voltage on the
Status Page.

7 Batteries Changed / This is a normal response on the Portable Clinical Analyzer

Ready for Use when the batteries are changed after a code 1 has occurred.

10 Temperature In Range / Temperature is back in range following a code 2 on the Portable

Ready for Use Clinical Analyzer.

11 Date Invalid / Check If the date in the real time clock precedes the release date
Clock on Status Page programmed into the application software, code 11 is triggered.
Check the date on the real time clock.
The accuracy of the clock is checked at the beginning of a
coagulation test. If the clock is inaccurate, Code 11 is triggered.

12 Invalid or Expired The CLEW standardization has expired. Download a valid

CLEW / See Manual CLEW.
The date on the real time clock exceeds the expiration date of
the CLEW software. Check the date on the real time clock.

13 Invalid or Expired The CLEW is corrupt or not compatible with the application
CLEW / See Manual software (JAMS), or there is no CLEW in the analyzer.
Download a valid CLEW. If this code occurs after a software
upgrade and the customization application is enabled in the
CDS, change the CLEW version in the Customization Profile to
the latest version and re-transmit the profile to the analyzer.

14 Analyzer Error / See Customization profile is corrupted. Retransmit the

Manual customization profile. If code 14 reoccurs, contact i-STAT
Technical Services or your local support organization for further
assistance.

95 Test Cancelled by This message will appear in the stored test records on the i-STAT
Operator 1 Analyzer if the analyzer powers down before mandatory
information was entered.

Art: 714260-01C Rev. Date: 01/25/05

The following codes are associated with the cartridge or fluid movement within a cartridge. These conditions can be
operator or sample related. In most cases, a new cartridge must be used. If a condition persists, especially if isolated to
one analyzer, there may an analyzer problem.

CODE CAUSE/ACTION EXPLANATION

NUMBER MESSAGE ON DISPLAY

19 NO CLOT DE TE TCE D / See During the PT/INR cycle, no clot was detected. Run another
Manual cartridge. If code 19 reappears, run the sample on an alternate
methodology.

22, 25 Cartridge Error / Use These codes occur only for coagulation cartridges if the mixing
Another Cartridge of the sample and reagent is compromised. This can be caused
by an insufficient or clotted sample, or by air bubbles in the
sample.

24 Cartridge Error / Use The electrical resistance of the calibrant fluid (Rcal) used to
Another Cartridge verify the electrolyte concentration is out of specification.
This could occur if the calibrant pack was ruptured well before
the test allowing evaporation to result in a higher electrolyte
concentration.
Besides the electrolyte concentration, the Rcal is also affected by
the temperature and the height and width of the fluid segment
over the conductometric sensor. The analyzer accounts for the
temperature, but the height and width of the fluid segment
can vary from cartridge lot to cartridge lot. The analyzer
has been programmed to compensate for these lot-to-lot
differences by maintaining a running average of the Rcal values
measured from the most recent cartridge runs. Occasionally,
the difference between the Rcal values for two cartridge lots is
large enough to cause the introduction of a new lot to trigger
code 24 on the first few cartridge runs. The Code 24 errors
should disappear as the running average adjusts. However,
if code 24 persists after more than 3 cartridge runs on each
analyzer, contact i-STAT Technical Services or your local support
organization.

26 Cartridge Error / Use This code occurs if there was a coagulation specific quality
Another Cartridge check failure: premature substrate activation, abnormally low
levels of substrate, or invalid fluid motion.

20, 27-29, Cartridge Error / Use These codes identify problems with the cartridge such as:
32, 33, 40, Another Cartridge calibrant fluid arriving too soon, too late, or not at all, or
41, 45, 87 noise in the calibrant fluid signals. Codes 20, 27, and 41 can
be caused by poor contact that can sometimes be corrected
by conditioning the pins in the analyzer using the ceramic
cleaning cartridge. The specific conditioning procedure is
described at the end of this bulletin.

42, 43 Cartridge Error / Use These codes indicate that the conductometric sensor (code 42)
Another Cartridge or the amperometric sensor (code 43) was out of specification.
This could be caused by a pre-burst calibrant pack, dirty
cartridge contact pads, or a dirty connector in the analyzer.

79-81 Cartridge Error / Use Bad contact between the thermal probes in the analyzer and the
Another Cartridge metalization on the back of the chips in the cartridge trigger
these codes. Causes are: poor metalization of the chips, dirt
on the metalization, or bent or broken thermal probes in the
analyzer.

Art: 714260-01C Rev. Date: 01/25/05

CODE CAUSE/ACTION EXPLANATION
NUMBER MESSAGE ON DISPLAY

21 CARTRID GE PRE B U RST / Use This code indicates that the analyzer detected fluid on the
Another Cartridge sensors before it should have. Possible causes: mishandling
of cartridges (putting pressure in the center of the cartridge),
poor storage conditions of cartridges (frozen), or rerunning used
cartridges.

31, 34, 44 Unable to Position The analyzer did not detect movement of sample across the
Sample / Use Another sensors. This could be due to a clot in the sample (especially in
Cartridge neonates), to not closing the snap closure on the cartridge, or to
an aberrant cartridge.

35, 36 Sample Positioned The cartridge was underfilled. The sample must reach the fill
Short of Fill Mark / Use mark. Try another cartridge.
Another Cartridge

30, 37 Sample Positioned The cartridge was overfilled. The sample was past the fill mark.
Beyond Fill Mark / Use Try another cartridge.
Another Cartridge

38, 39 Insufficient Sample / This is most likely due to insufficient sample in the sample
Use Another Cartridge well of the cartridge, but can also be caused by bubbles in the
sample. Try another cartridge and ensure sufficient sample is in
the sample well.

46 Cartridge Error / Use The analyzer did not detect movement of sample across the
Another Cartridge sensors. This could be due to a clot in the sample (especially in
neonates), to not closing the snap closure on the cartridge, or to
an aberrant cartridge.

47 Cartridge Not Inserted This code indicates the cartridge or Electronic Simulator
Properly / Reinsert may not be pushed in all the way. Reinsert the cartridge or
Cartridge Electronic Simulator. If the problem persists and/or the user
is certain the cartridge or Simulator is properly inserted, it
may indicate an analyzer problem. Contact i-STAT Technical
Services or your local support organization for further
assistance.

48 Analyzer Error / See This code indicates the cartridge or Electronic Simulator may
Manual have been “cocked” when inserted. Push the cartridge or
Simulator straight through the cartridge port. If the problem
persists, and the user is certain the cartridge or Simulator is
properly inserted, it may indicate an analyzer problem. Contact
i-STAT Technical Services or your local support organization for
further assistance.

Art: 714260-01C Rev. Date: 01/25/05

The following conditions are related to electronic or mechanical failures in the analyzer.

CODE CAUSE/ACTION EXPLANATION

NUMBER MESSAGE ON DISPLAY

50 AN ALY ZE R ERROR / Use The motor has moved too far. Running a simulator may not detect this
Electronic Simulator problem. Run the simulator and if the analyzer passes, run a cartridge to see
if the code reoccurs. If not, continue to use the analyzer. If the code reoccurs,
contact I-STAT Technical Services or your local support organization for
further assistance.
If testing immunoassay cartridges on an i-STAT 1 Analyzer, this code can
be related to poor electrical connection between the i-STAT 1 Analyzer
and the cartridge. This can sometimes be corrected by conditioning the
pins in the analyzer using the ceramic conditioning cartridge. The specific
conditioning procedure is described at the end of this bulletin.
Codes 126 and 128 are sometimes related to electrical connection as well.
If you experience multiple occurrences of these 3 codes (50, 126, and 128)
in a short period of time, consider returning the analyzer for servicing and
replacement
The presence of sample bubbles when running immunoassay cartridges
may, under some circumstances, also elicit this code.

51 Analyzer Error / Use The motor moved for too long. Run a simulator. If the error occurred while
Electronic Simulator running an ACT cartridge, also run a cartridge. If the code does not reoccur,
continue to use the analyzer. Under some conditions, a low battery will cause
this error instead of code 1. Try fresh batteries. If the code reoccurs, contact
I-STAT Technical Services or your local support organization for further
assistance.

52 Analyzer Error / Use The motor stalled while moving. Run a simulator. If the error occurred while
Electronic Simulator running an ACT cartridge, also run a cartridge. If the code does not reoccur,
continue to use the analyzer. If the code reoccurs, contact I-STAT Technical
Services or your local support organization for further assistance.

58-62 Analyzer Error / Use The analyzer usually recovers from these error conditions. These error
Electronic Simulator conditions can be detected by the Electronic Simulator. If the analyzer passes
the Electronic Simulator test, continue to use it. If not, check the battery
voltage and check the analyzer with another simulator to rule out a simulator
problem. If the code persists, contact i-STAT Technical Services or your local
support organization for further assistance.

Art: 714260-01C Rev. Date: 01/25/05

 CODE CAUSE/ACTION EXPLANATION
NUMBER MESSAGE ON DISPLAY

23, 53, AN ALY ZE R ERROR / See These are mechanical or electronic failures from which the analyzer may not
63, 65- Manual be able to recover.
68, 70,
Code 23 may be caused by poor contact between the analyzer pins and the
72-74,
cartridge chip. This can sometimes be corrected by conditioning the pins in
82, 85,
the analyzer using the ceramic cleaning cartridge. The specific conditioning
86, 89-
procedure is described at the end of this bulletin.
94, 96,
97 Code 70 can occur on the Portable Clinical Analyzer if the user presses the
DIS key before the Electronic Simulator is run after a software update. If this
happens, reseat the batteries to reset the analyzer, and then run the Electronic
Simulator.
Codes 82 and 92 typically indicate a problem with the pressure transducers in
the analyzer. If these codes persist, contact i-STAT Technical Services or your
local support organization for further assistance.
For other codes, run the Electronic Simulator twice, then run a cartridge
with a sample. If the analyzer passes the simulator check and a quality
check does not occur with the sample run, continue to use the analyzer. If
the analyzer does not pass the simulator check and/or a quality code occurs
with the sample run, contact i-STAT Technical Services or your local support
organization for further assistance.

69 Cartridge Type Not This code could be due to use of a cartridge type that is not compatible with
Recognized / Use the version of software in the analyzer, or the use of expired cartridges. Check
Another Cartridge the cartridge expiration date on the cartridge box or pouch. If the cartridges
have not expired, and if a new cartridge type is being run, contact i-STAT
Technical Services or your local support organization for a software update.
When running coagulation cartridges, Code 69 may be caused by poor contact
between the analyzer pins and the cartridge chip. This can sometimes be
corrected by conditioning the pins in the analyzer using the ceramic cleaning
cartridge. The specific conditioning procedure is described at the end of this
bulletin.
During immunoassay cartridge runs, this code will be displayed if
incorrect information is entered in response to the prompt “Enter or Scan
Cartridge Lot Number”.
The instrument expects the barcode on the back of the individual
cartridge portion pack to be scanned. The correct barcode looks like this:

For immunoassay cartridges, the instrument will not accept keypad entries
of the cartridge lot number nor a scan of the barcode on the cartridge box.
This condition may be due to an aberrant cartridge. However, if the condition
occurs repeatedly on one analyzer, the analyzer may need repair. Contact
i-STAT Technical Services or your local support organization for further
assistance.

Codes 100-111 indicate a condtion with the PCx Glucose Test Strip on the I-STAT 1 Analyzer

Art: 714260-01C Rev. Date: 01/25/05

 CODE CAUSE/ACTION EXPLANATION
NUMBER MESSAGE ON DISPLAY

100 STRIP ERROR / Use The user tried to run a wet strip. Remove the test strip. Press 1 for Test
Another Strip Options. Press 1 for Same Patient or Level. Repeat the test.

101 Strip Error / Use The test strip was removed from the strip port during testing. Press 1
Another Strip for Test Options. Press 1 for Same Patient or Level. Repeat the test.

103, 105, Strip Error / Use Test unsuccessful. An error was detected during the analysis sequence.
106, 107, Another Strip Remove the test strip. Press 1 for Test Options. Press 1 for Same
111 Patient or Level. Repeat the test. If the problem persists, record the
three digit error code and contact MediSense support services or your
local support organization.

102, 104 Strip Error / Use The test strip malfunctioned or the blood glucose level in the sample
Another Strip is beyond the measuring capability of the test strip and strip reader.
Remove the test strip. Press 1 for Test Options. Press 1 for Same
Patient or Level. Repeat the test with a new test strip. If the error
occurs again, confirm the result by performing the test on a different
method. Contact MediSense support services or your local support
organization.

108, 109 Temperature Out of During the test, room temperature became unstable or moved outside
Range / Check Status the limits within which the test strip reader can perform a test. Ensure
Page that the room temperature is within the specified limits. Allow the
analyzer to stabilize to a room temperature of 15-40ºC or 59-104ºF.
Press the Menu key until the Administration Menu is displayed. Press
1 for Analyzer Status where the room temperature reading is displayed.
If the temperature reading on the Status Page is within the limits
described above, yet these codes persist, there may be a problem with
one of the thermistors in the analyzer. Contact i-STAT Technical
Services or your local support organization for further assistance.

110 Strip Error / Use At the start of the test strip cycle, the analyzer prompts the user to
Another Strip apply blood to the strip and waits for 20 minutes for the user to do so.
This error occurs when the 20 minutes have elapsed and the analyzer
didn’t detect blood. The most likely cause of this error is lack of user
interaction.

Codes in the range of 120 to 137 and 140 to 148 indicate a failure during an immuno cartridge cycle. In most cases,
the cartridge is spent and another cartridge must be used. Only the i-STAT 1 Analyzer produces these codes, as the
Portable Clinical Analyzer does not support immuno cycles.

CODE CAUSE/ACTION EXPLANATION

NUMBER MESSAGE ON DISPLAY
120-122, CARTRID GE ERROR / Use These codes indicate a problem with the movement of the analysis fluid
124, 125, Another Cartridge during the cartridge run. Try another cartridge.
133, 144
123 Cartridge Error / Use The quality control during the cartridge run failed to verify the presence
Another Cartridge of active immuno reagents. Try another cartridge.

Art: 714260-01C Rev. Date: 01/25/05

 CODE CAUSE/ACTION EXPLANATION
NUMBER MESSAGE ON DISPLAY
126 CARTRID GE ERROR / Use This code can be related to poor electrical connection between the
Another Cartridge i-STAT 1 Analyzer and the cartridge. This can sometimes be corrected by
conditioning the pins in the analyzer using the ceramic conditioning
cartridge. The specific conditioning procedure is described at the end of
this bulletin.
Codes 50 and 128 are sometimes related to electrical connection as
well. If you experience multiple occurrences of these 3 codes (50, 126,
and 128) in a short period of time, consider returning the analyzer for
replacement.
127 Cartridge Error / Use A wet sensor was detected before the initial sample movement. Possible
Another Cartridge overfilled or used cartridge. Try another cartridge.
128, 131, Cartridge Error / Use These codes are most often related to poor filling of an immunoassay
132, 134, Another Cartridge cartridge, the presence of sample bubbles, or the abrupt insertion of a
135 - 137 cartridge into the analyzer.
Guidelines for proper filling:
1. Discard (always) 1 drop from delivery device to clear unseen bubbles.
2. Hang single drop slightly larger than round target well.
3. Touch one drop (only) to round target well allowing cartridge to
draw sample in.
4. Confirm sample volume lines up with top of RED FILL LINE
diagram.
5. Close slide cover from left to right.
Guidelines for cartridge insertion:
1. After closing the cartridge, grasp the cartridge closure between
your first finger and thumb. There is a recess for your thumb in the
closure.
2. Guide the cartridge into the analyzer gently, until a soft click is
heard.
129, 142, Cartridge Error / Use The analyzer detected analysis fluid mixed with the sample. Try another
143 Another Cartridge cartridge.
130 Cartridge Error / Use The analyzer detected an air bubble in the sample segment. Try another
Another Cartridge cartridge.
140 Lot Expired The analyzer detected an expired cartridge lot. Check the expiration date
and repeat the test using a non-expired cartridge lot.
141 Test Canceled by This code will be displayed if the cartridge barcode is not scanned within
Operator 60 seconds of cartridge insertion. The correct barcode to scan is the
barcode on the cartridge portion pack, not the one on the cartridge box.
An example of the portion pack barcode is found in the table listing for
code 69 above.
145 Cartridge Error / Use The analyzer failed to detect fluid arrival upon the initial sample push.
Another Cartridge This may be caused by a(n):
• cartridge leak,
• failure to close the cartridge completely. Ensure that the slide cover
is fully engaged before inserting the cartridge into the analyzer
• underfilled cartridge. Once a single drop of sample is touched to the
target well, immunoassay cartridges will fill automatically by wicking
the sample at a fixed speed. Trying to inject the sample into the
cartridge or adding more sample to the target well will not make the
cartridge fill faster. Wait for the sample to reach the “fill to” mark,
and then close the cartridge.

Art: 714260-01C Rev. Date: 01/25/05

 CODE CAUSE/ACTION EXPLANATION
NUMBER MESSAGE ON DISPLAY
146 CARTRID GE ERROR / Use Overfilled cartridge. Repeat the test.
Another Cartridge
147 Analyzer Error / See In order to run an immunoassay cartridge, the i-STAT 1 Analyzer must:
Manual
• bear the symbol and
• be customized for
a) Cartridge Barcode Required, or
b) Cartridge Information First Required and Cartridge Lot Number
Required.
If either of these two conditions above are not met, the analyzer will
display this code.

The following conditions are related to the Electronic Simulator

CODE EXPLANATION HOW TO RESPOND

NU M E RICAL See under Analyzer Coded Messages. See under Analyzer Coded Messages.
COD E

L Potentiometric channel out of limits. Allow analyzer to equilibrate in new environment

Can occur if moisture collects on the for 30 minutes and repeat test. If code reoccurs,
contact pins inside the analyzer when return anlayzer.
the analyzer is subjected to ambient
temperature change.

G Amperometric channel out of limits. Reinsert the simulator straight. If code reoccurs,
Can occur if external simulator not return analyzer.
inserted straight.

R, r Resistance reading on conductometric Return analyzer.

channel out of limits.

t Thermal probe failure. Return analyzer.

B Potentiometric channel out of limits. Return analyzer.

NOTE: Any time repetitive codes occur which cannot be addressed or corrected through training, contact
i-STAT Technical Services or your local support organization for further assistance.

Art: 714260-01C Rev. Date: 01/25/05

PROCEDURE FOR USING AN i-STAT CERAMIC CONDITIONING CARTRIDGE (CCC) FOR ANALYZER
PIN CONDITIONING

STEP NUMBER EXPLANATION

1. Run an external Electronic Simulator. If the analyzer is configured with the internal Electronic
Simulator enabled, run an external Electronic Simulator.
Running the external Electronic Simulator ensures the internal
Simulator cycle will not execute during the pin conditioning
process, which could lead to the premature termination of the
process.

2. Run the CCC two times. Initiate the CCC cycle as you would initiate an external
Electronic Simulator cycle. The instrument will identify the
CCC as an external Electronic Simulator and display a Simulator
Failure Code (i.e. rRGL) when the cycle is complete. Disregard
the code, as this is expected behavior.

3. Update the CCC Usage Log The log is located on page 3 of the Technical Bulletin entitled
“Instructions for Restoring Analyzers That Produce *** for
Hematocrit and Quality Check Code 23”, which is shipped with
the CCC. Updating the log allows the user to keep track of the
number of pin conditioning cycles performed with the current
ceramic strip in the CCC. If necessary, replace or rotate the
ceramic strip so the CCC is ready for future use.

4. Return the analyzer to service.

Art: 714260-01C Rev. Date: 01/25/05

 TECHNICAL
BULLETIN

Installation Guide for the Central Data Station to Receive Data

from a Philips Clinical Data Server*
The i-STAT Central Data Station (CDS) application can be configured to receive results from cartridges analyzed on a Philips
Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM) for the CMS and 24/26 Patient Monitors. This
data is sent to the CDS by the Philips Clinical Data Server (Philips). This document describes how to set up the i-STAT CDS
application to receive data from the Philips Clinical Data Server. It is independent of the computer hardware platform being used.

Configuration This guide assumes that the Philips Clinical Data Server connectivity to the location of the CDS computer
Instructions is completed, and that the Philips Clinical Data Server data is available via one of these two protocols:

• A direct RS-232 serial connection

• An Ethernet connection to a ETS 8 Terminal Server (CDS 4.x) or a Network Interface Card (CDS5.x)

To configure the CDS 5.x:

Step Action
1 Run the CDS application (wcds32.exe) with the “config” command line parameter.

The remainder of the configuration is dependent on the connection of the Philips Clinical Data
Server to the CDS.

For Philips Clinical Data Server data received via a For Philips Clinical Data Server data received via a
direct RS-232 connection: Network Interface Card:
2 Determine which COM Port of the CDS 2 At the Network tab page, select “Enable
computer is to be used for the Philips Network Communications”. Note the
Clinical Data Server data. default of 6002 for Agilent Connect TCP
port, change if neccessary. Click
“Accept”.
3 At the Serial Ports tab page, select
“Enable Serial Communications”. Add
the COM Port to be used for the Philips 3 Verify that the Philips Clinical Data
Clinical Data Server to the “Configured Server is configured to transmit to the
Ports” list, select Agilent Connect as specific port noted in step 2 at the CDS
instrument type, and click “Accept”. IP network address.

4 Connect the cable to the appropriate 4 Verify that the Philips Clinical Data
COM Port on the CDS computer. Server data is being received.

5 Verify that the Philips Clinical Data

Server data is being received.

* This product has formerly been known as HP Patient Data Server and Agilent Connect.

P/N: 014270-01 01 Art: 714270-01A Rev. Date: 22/01/02

To configure the CDS 4.x:
Step Action
1 Determine which COM Port of the CDS computer is to be used for the Philips Clinical Data
Server data.

2 Using the Configuration Utility of the CDS, change the data source of this COM Port to the “CDS”
option.

3 Exit the Configuration Utility.

The remainder of the configuration is dependent on the form of the Philips Clinical Data Server
data.

For Philips Clinical Data Server data received via a For Philips Clinical Data Server data received via an ETS
direct RS-232 connection: 8 Terminal Server:
4 Determine the communication speed of 4 Determine which serial port on the ETS
the Philips Clinical Data Server. Ideally, 8 will be used for the Philips Clinical
it should be set at 19200 baud. Data Server transmission.

5 • If set to 19200, use any text editor to 5 Verify that the Philips Clinical Data
edit the file C:\istatcds\istatcfg.txt. Server is configured to transmit to that
specific port at the ETS 8 Ethernet
address
Add the following line to the section with
the heading of
[Options]: 6 Verify that the port of the ETS 8 is
configured for 19200 baud.
FastCdsSend=YES
Save the file and exit the Text Editor.
7 Using any text editor, edit the file
• If set to 4800, no changes are needed C:\istatcds\istatcfg.txt.

6 Connect the cable to the appropriate Add the following to the section with the
COM Port on the CDS computer. heading of
[Options]:
7 Verify that the Philips Clinical Data FastCdsSend=YES
Server data is being received. Save the file and exit the Text Editor.

8 Connect the cable from the selected

ETS 8 serial port to the selected COM
port on the on the CDS computer.

9 Verify that the Philips Clinical Data

Server data is being received.

P/N: 014270-01 01 Art: 714270-01A Rev. Date: 22/01/02

 TECHNICAL
BULLETIN

ACT Test Result Calibration Options:

PREWARMED vs. NON-PREWARMED Result Calibration Modes
for the i-STAT®1 Analyzer
BACKGROUND
The Activated Clotting Time (ACT) test has been in existence for over 30 years. It
is the most popular test for measuring the effect of heparin administered during an
interventional procedure. By placing an activator in the test chamber, the blood sample
is “activated” to promote clotting. When heparin is present in the sample, the clotting is
delayed in proportion to the amount of “anticlotting” effect of the heparin.

Since its inception, numerous changes have taken place to ACT tests, including increased
automation and decreased sample volume. Today, there are many new, fully automated,
low blood volume ACT tests on the market, in addition to the older, macro blood volume,
semi-automated tube-based systems (i.e., Hemochron®, Actalyke™). The micro sample
ACT systems typically employ test cartridges or cards (instead of tubes), and all have
incorporated an automatic test cycle prewarming step that brings the ACT testing chamber
to 37°C prior to initiating the clotting reaction. As blood clotting is an enzymatic process,
the temperature at which the clotting cycle takes place has a marked impact on the rate at
which the blood clot forms. The ACT tests that incorporate a prewarming step allow the
entire clotting reaction to take place at 37°C. ACT tests that do not use a prewarming step
are subject to a delay before the blood specimen reaches (and stabilizes at) 37° degrees; the
actual time needed to reach 37°C is dependant on the starting temperature of the sample
test tube. For example, a 30°C blood sample placed into a (non-prewarmed) 25°C ACT
tube will take a few minutes before the test environment (blood, reagent, tube) stabilizes at
37°C. The result of this thermal delay is an increase in the reported ACT clot time that will
depend on sample tube temperature.

ACT Instruments WITH an automatic ACT Instruments WITHOUT an

prewarming step automatic prewarming step
Medtronic® ACTII (plus) Hemochron 801/401/8000/Response
Medtronic HMS (plus) Actalyke
Bayer/TAS HMT
Roche ACT
Hemochron® Jr. (Signature/PCL)
i-STAT

i-STAT Corporation • 104 Windsor Center Drive • East Windsor, NJ 08520 • (800) 366-8020
Art: 715617-01B Rev. Date: 12/15/03
i-STAT ACT CALIBRATION

Currently, the i-STAT® Celite® ACT and i-STAT® Kaolin ACT tests are factory calibrated by
mathematically adjusting the raw i-STAT “clot time” to match the Hemochron® Celite tube
result. This calibration is performed by testing cartridges and Hemochron Celite tubes side
by side, using a range of heparinized, non-hemodiluted whole blood samples, and using
Hemochron tubes prewarmed to 37ºC.

Customers who are familiar with macro-sample ACT methods like Hemochron and
Actalyke™, and who do not preheat their tubes prior to each test, have found that the bias
in results between their previous ACT method and the i-STAT ACT may require changing
familiar clotting time target values. In order to ease the changeover to the i-STAT ACT
method under these circumstances, i-STAT now provides a choice between the current 37ºC
result calibration and a new “non-prewarm” (or ambient temperature) result calibration.
The additional calibration mode allows an i-STAT ACT cartridge to deliver results that will
be a closer match for those users who are familiar with macro-sample methods without
automatic prewarming cycles, and should reduce the need to make large changes to ACT
target times or ranges. Since micro-sample methods (Medtronic HR-ACT, Hemochron
Jr. ACT+) already incorporate preheating of the test cuvettes, users with ACT target times
and ranges based on these methods should continue to use their current i-STAT 37ºC
calibration.

2 Art: 715617-01B Rev. Date: 12/15/03

REPRESENTATIVE DATA
Effect of Sample Tube Temperature on Hemochron ACT Results using Paired Samples:
Prewarmed sample tubes vs. Non-prewarmed sample tubes.

Art: 715617-01B Rev. Date: 12/15/03 3

 i-STAT Celite ACT vs. Room Temperature Hemochron FTCA510: Prewarmed (PREWRM) vs.
Non-prewarmed (NONWRM) calibration modes.

4 Art: 715617-01B Rev. Date: 12/15/03

ANALYZER DISPLAY AND CDS CHANGES
Due to the new ACT result calibration option, there are several changes to the analyzer
display as well as to the Central Data Station (CDS). Major changes are noted below:

• The i-STAT PCA and BAM are NOT capable of offering the new ACT result
calibration option. All PCA and BAM ACT results continue to use the original
ACT calibration (PREWRM). To clearly identify this calibration, ACT results
reported on the i-STAT PCA will show PREWRM on the result screen.

• The ACT test results that will be displayed on the i-STAT 1 analyzer now show
the calibration setting that was used to perform the ACT calculations.

Art: 715617-01B Rev. Date: 12/15/03 5

 • The i-STAT 1 analyzer is capable of offering both the NONWRM and PREWRM
ACT customization settings. These customizations can be viewed, selected and
changed via the RESULTS CUSTOMIZATION section on the i-STAT 1 analyzer

Results Results
Customization Customization
Change Change
1 Decimal Separator Customization 1 ACT-K Customization
(.) Period ACT-C PREWRM ACT-K
2 Test Selection 1-PREWRM 2 Print 1-PREWRM
Disabled Ref. Ranges
2-NONWRM Disabled 2-NONWRM
3 Hematocrit
Prompt CPB
K3 EDTA

4 Base Excess
ecf

5 ACT-C
PREWRM

Page Page

Celite ACT handheld customization. Kaolin ACT handheld customization.

• For i-STAT 1 analyzers used in conjunction with CDS version 5, the new ACT
customization options are located on the RESULTS tab of the Preferences section
of the individual customization profile (see highlight). Users should select the
desired calibration mode for each i-STAT ACT type (Celite and/or kaolin).

6 Art: 715617-01B Rev. Date: 12/15/03

LIMITATIONS AND WARNINGS
• The NONWRM calibration mode applies to the Patient Path only, and will not
be applied to the Control or Proficiency Testing pathway. Control or Proficiency
samples run in the Patient Pathway may produce erroneous results.
• Different locations within a given hospital may utilize different calibration
modes/customization profiles. Prior to testing patient samples, ensure the
appropriate calibration mode is employed.

i-STAT® is registered trademark of i-STAT Corporation

Actalyke® is a registered trademark of Helena Laboratories
Hemochron® is a registered trademark of International Technidyne Corporation
Hemotec® is registered trademark of Medtronic Corporation
Celite is trademark of the Celite Corporation

Art: 715617-01B Rev. Date: 12/15/03 7

8 Art: 715617-01B Rev. Date: 12/15/03
 TECHNICAL
BULLETIN

October 2004 Update to the i-STAT Central Data Station Version 5

CENTRAL DATA STATION LOGON

Previously open windows will now be restored when a user logs on to the CDS
application again.

OPERATOR WORKSPACE
An option has been added to have page breaks between the departments listed in
the Operator Certification Expiration report.

CUSTOMIZATION WORKSPACE
In the “Default customization profile:” column, a new “i-STAT 1 Software” selection
box has been added in preparation for a new February 2005 feature allowing users
to remotely request a JAMS update from the CDS.

i-STAT Corporation • 104 Windsor Center Drive • East Windsor, NJ 08520 • (800) 366-8020
Art: 716134-01A Rev. Date: 07/12/04
USER ADMINISTRATION WORKSPACE
A User Log tab has been added to the User Administration Workspace. The
activities tracked by this log include:

a. CDS Startup
b. CDS Shutdown
c. User Logon
d. Manual User Logoff
e. Automatic User Logoff, and
f. Disabling of the Security Feature via the Configuration Screen

TRENDING
“CPB Applied” and “Panel Code” have both been added as new rows in the Trend
display and printout.

2 Art: 716134-01A Rev. Date: 07/12/04

DATA EXPORT
A data export option is now available in the following areas of the Central Data
Station application:

a. Data Viewers
b. Reports
c. Trend report, and
d. the Extended Simulator report screen

To access this option from any of the Data Viewers or Reports, click on Window ➩
Export. From a Trend report or the Extended Simulator report screen, click on the
Export data… button at the bottom of the report. A dialog box will then appear
on the screen. Choose the file destination location and the type of file you want
the exported data saved as from the drop-down menus, then type in the File Name
and click on Save.

Note: Users can be blocked from or allowed access to this data export feature
through the User Administration Workspace by using the check box
“Export data in patient data viewers” under the Security Options for
Selected Profile section.

Art: 716134-01A Rev. Date: 07/12/04 3

4 Art: 716134-01A Rev. Date: 07/12/04
 TECHNICAL
BULLETIN

APRIL 2005 UPDATE TO THE i-STAT CENTRAL DATA STATION VERSION 5

TRENDING
The “Panel Code” row has been renamed as “Panel” and now lists the name of the
cartridge type run for each individual record in the Trend display and printout.

CUSTOMIZATION WORKSPACE
A new feature allows users to remotely request both a JAMS and a CLEW update for
an i-STAT 1 Analyzer from the CDS.

Notes:
• This new feature does not apply to the Portable Clinical Analyzer or to
the Philips Blood Analysis module.
• The procedure for uploading a new CLEW version into the i-STAT 1
Analyzer remains the same. To upload just a CLEW version, users
transfer the new CLEW files to the CDS, select the new CLEW version in
the Customization Workspace, and then transmit the i-STAT 1 Analyzers
to the CDS.
• If the CDS is on version 5.18a or higher, users no longer need to disable
Customization prior to uploading analyzer software using the Jammlite
utility.

Art: 716244-01A Rev. Date: 03/01/05

 After installing CDS version 5.18a, to perform a JAMS and CLEW update on an
i-STAT 1 Analyzer using this new Customization feature:

1. Transfer the Files

• Place the JAMS diskette into the A: drive.
• Click Start ➩ Run…
• Type: a:transfer and press the Enter key.

Note: If you do not have access to the Run… command, contact your Point-of-
Care Coordinator or Information Technology (IT) department.

2. Start the Central Data Station Application (if not already open)
• Click on the Central Data Station icon.

3. Access the Customization Workspace

• Click on Main ➩ Open Administration Function ➩ Customization
• Type in the Password. The default password is istat.

4. Enable Customization
• If the Enable Customization box is not already checked, click the box
next to this listing.
• Under the “Location-based customization profile:” section, make sure
Enable Updates is checked for every location from which you wish to
perform software updates on your i-STAT 1 Analyzers.

5. Select the Desired Analyzer CLEW and i-STAT 1 Software

• Under the “Default customization profile:” column, click on the i-STAT
Analyzer CLEW button. Click the new version of CLEW and click OK.
• Under the “Default Customization profile:” column, click on the
i-STAT 1 Software button. Click the new i-STAT 1 software file and
click OK.

2 Art: 716244-01A Rev. Date: 03/01/05

 6. Update the Software in the i-STAT 1 Analyzer
• Go to the location where the i-STAT 1 Analyzers you wish to update are
located.
• Press the On/Off button on the analyzer to turn the display on.
• Press the Menu key to bring up the Administration Menu.
• Press 7 for Utility. The Utility menu may be password protected. Enter
the password or press the Enter key if no password has been specified.
• From the Utility Menu, select 3-Receive Software. The “Waiting to
Send” message will appear on the analyzer display.
• Place the analyzer in the downloader or downloader/recharger. A
Communication in Progress message will appear on the screen. After
this message disappears, the analyzer display will stay blank for
approximately 5-10 seconds. Please note that this blank screen is
normal analyzer behavior during this part of the procedure.
• A scrolling bar will then appear on the analyzer display. This bar
indicates that the software is uploading into the analyzer. Do not
move the analyzer while the scrolling bar appears on the display
screen. When the upload process is complete, the scrolling bar
will disappear and the analyzer display will again go blank for
approximately 5-10 seconds. Please note that this blank screen is
normal analyzer behavior during this part of the process.
• A Waiting to Send message followed by a Communication in Progress
message will then appear on the analyzer display. After these messages
disappear, the analyzer display will go blank, and the update process is
complete.

7. Verify the Update

• Run an external Electronic Simulator on updated Analyzers and check
the Analyzer Status page for the new Application software and/or
CLEW.

Art: 716244-01A Rev. Date: 03/01/05 3

4 Art: 716244-01A Rev. Date: 03/01/05
 TECHNICAL
BULLETIN

K2EDTA and K3EDTA Customization for Hematocrit on the

i-STAT® System

PURPOSE
This Technical Bulletin contains the information needed to select the K2EDTA
or K3EDTA customization option for reporting hematocrit results on the i-STAT�
System.

HEMATOCRIT CALIBRATION
The reference method for hematocrit is the microhematocrit (MH) method. All
instruments measuring hematocrit are expected to be traceable, or calibrated, to
this reference method.1-3

The microhematocrit reference method described in NCCLS H7-A33 permits both

K2EDTA and K3EDTA anticoagulant sample collection tubes. K3EDTA anticoagulant
shrinks red blood cells relative to K2EDTA anticoagulant, causing microhematocrit
results from K3EDTA samples (MH-K3EDTA) to be lower by approximately 2 – 4%
than results from K2EDTA samples (MH-K2EDTA).3,4

Consequently, instruments calibrated to MH-K3EDTA report lower hematocrit

results than analyzers calibrated to MH-K2EDTA.

SELECTION OF THE K2EDTA OR K3EDTA CUSTOMIZATION SETTINGS ON THE i-STAT SYSTEM

i-STAT provides two customization settings for reporting hematocrit results: The
“K3EDTA” customization reports hematocrit results traceable to MH-K3EDTA. The
“K2EDTA” customization reports hematocrit results traceable to MH-K2EDTA.

For best agreement of i-STAT and hematology analyzer hematocrit results, the
i-STAT customization setting is selected according to the calibration of the
comparative hematology analyzer (MH-K2EDTA or MH-K3EDTA).

i-STAT has verified with the manufacturers of the Advia®, Cell-Dyn®, Coulter®
and Sysmex® hematology analyzers that hematocrit results on these analyzers are
calibrated to MH-K3EDTA. Because these hematology analyzers report hematocrit
results calibrated to MH-K3EDTA and are representative of the hematology market,
“K3EDTA” was chosen as the factory default customization setting for the i-STAT
System.

When the calibration of a comparative method is uncertain, determine the

customization setting by minimizing the average bias between methods as follows:

Art: 716240-01A Rev. Date: 02/28/05

 • Check that the results from hematocrit controls for both i-STAT and
comparative methods are acceptable.

• If i-STAT hematocrit results obtained using the “K3EDTA” setting are

consistently lower than those on the comparative method, the “K2EDTA”
setting may be a better choice. If agreement is better after multiplying
the “K3EDTA”-customized i-STAT results by 1.0425, the customization
setting should be switched to “K2EDTA”.

• Conversely, if i-STAT hematocrit results obtained using the “K2EDTA”

setting are consistently higher than those on the comparative analyzer,
the “K3EDTA” setting may be a better choice. If agreement is better
after dividing the “K2EDTA”-customized i-STAT results by 1.0425, the
customization setting should be switched to “K3EDTA”.

• If an unacceptable system bias still exists, contact i-STAT Technical

Support at 1-800-366-8020, option 1.

HEMATOLOGY ANALYZERS AND K2EDTA AND K3EDTA SAMPLE COLLECTION TUBES

Hematocrit results on hematology analyzers from samples collected in K3EDTA and
K2EDTA tubes will be equivalent. This is because the osmotically-balanced diluent
reverses the red blood cell shrinkage caused by the anticoagulant.5 It should be
clear that results from K2EDTA and K3EDTA tubes will be equivalent, but lower,
on an analyzer calibrated to MH-K3EDTA than on an analyzer calibrated to MH-
K2EDTA.

i-STAT has become aware that some customers have selected their i-STAT hematocrit
customization according to the type of EDTA anticoagulant in the collection tube
used for samples for the hematology analyzer. As explained above, the selection
of the “K2EDTA” or the “K3EDTA” customization for i-STAT analyzers is based
upon the microhematocrit method (MH-K2EDTA or MH-K3EDTA) to which the
hematology analyzer is calibrated, rather than on the collection tube used for the
hematology analyzer.

EXPECTED LEVEL OF METHOD AGREEMENT

Average i-STAT hematocrit results over a group of samples should normally agree
with those from the comparative method within ± 2 %PCV at 29 %PCV and
below, ± 3 %PCV from 30 to 50 %PCV, and within 10% above 50 %PCV when the
following conditions are met:
• i-STAT analyzers are customized correctly.
• Comparative analyzer is calibrated correctly.
• Sample handling is optimal for both i-STAT and comparative methods.
• Samples are unaffected by factors listed in the i-STAT Cartridge and Test
Information sheet for Hematocrit or in the user documentation for the
comparative method.

Note: The original agreement criteria recommended by i-STAT for the

calibration verification procedure (using the microhematocrit method)
was 3 %PCV across the entire measurement range. i-STAT believes that
these new criteria are more clinically relevant and should be applied to
method comparisons and the calibration verification procedure.

2 Art: 716240-01A Rev. Date: 02/28/05

REFERENCES
1. Bull BS, van Assendelft OW, Fujimoto K, et al (International Council
for Standardization in Haematology Expert Panel on Cytometry).
Recommendations for Reference Method for the Packed Cell Volume
(ICSH Standard 2001). Lab Hematol. 7:148-170 (2001).

2. NCCLS. Calibration and Quality Control of Automated Hematology Analyzers;

Proposed Standard. NCCLS document H38-P [1-56238-398-1]. NCCLS,
940 West Valley Road, Suite 1400, Wayne, Pennsylvania 1908 –1898 USA,
1999.

3. NCCLS. Procedure for Determining Packed Cell Volume by the Microhematocrit

Method; Approved Standard – Third Edition. NCCLS document H7-A3 [ISBN
1-56238-413-9]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 1908 –1898 USA, 2000.

4. Gotch F, Torres L, Evans M, Keen M, Metzner K, Westpal D, Polascegg H.

Comparison of Conductivity Measured Hematocrit to Microhematocrit.
ASAIO Transactions 37:M138-139 (1991).

5. Parikh, M. Evaluation of BD Vacutainer™ Plus Plastic 4.0mL K2EDTA,

2.0mL K2EDTA and Glass 5.0mL K3EDTA Tubes for CBC, WBC Differential
Count and Reticulocyte Count. (Technical Literature). Becton, Dickenson
and Company, 2003.

i-STAT is a registered trademark of i-STAT Corporation, East Windsor, NJ

Advia is a registered trademark of Bayer Diagnostics, Tarrytown, NY
Cell-Dyn is a registered trademark of Abbott Laboratories, Abbott Park, IL
Coulter is a registered trademark of Beckman Coulter, Inc., Fullerton, CA
Sysmex is a registered trademark of Sysmex Corporation, Kobe, Japan

Art: 716240-01A Rev. Date: 02/28/05 3

4 Art: 716240-01A Rev. Date: 02/28/05
 TECHNICAL
BULLETIN

SUPPORT SERVICES
Abbott Point of Care and its distributors are committed to helping you resolve any problems with the i-STAT
System: Portable Clinical Analyzer, i-STAT 1 Analyzer, cartridges, accessories and Central Data Station software.
For technical assistance within the United States, please call Technical Services at 800-366-8020 toll free.
Outside the U.S., please contact your local i-STAT distributor.

North America
USA Canada
Abbott Point of Care Abbott Point of Care
104 Windsor Center Drive 104 Windsor Center Drive
East Windsor, NJ USA 08520 East Windsor, NJ USA 08520
Tel: 800-366-8020, option 1 Tel: 800-387-8378 (English)
Tel: 877-529-7185 Tel: 800-465-2675 (French)
Fax: 609-469-0280 Fax: 609-469-0280
Email: [email protected] Email: [email protected]

Africa
Angola Botswana Comoros Islands
Magnamed The Scientific Group Ltd. The Scientific Group Ltd.
Rua Alexandre Ferreira, 31-A P.O. Box 13119 P.O. Box 13119
1750-010 Lisbon Vorna Valley 1686 Vorna Valley 1686
Portugal South Africa South Africa
Tel.No.: +351-21 352 45 39 Tel.No.: +27-11-652-4000 Tel.No.: +27-11-652-4000

Lesotho Island Madagascar Malawi

The Scientific Group Ltd. Techno Scientific Ltd. The Scientific Group Ltd.
P.O. Box 13119 Hill Lane P.O. Box 13119
Vorna Valley 1686 Solferino, Phoenix Vorna Valley 1686
South Africa Mauritius South Africa
Tel.No.: +27-11-652-4000 Tel.No.: +230 424 1881 Tel.No.: +27-11-652-4000

Mauritius Mozambique Namibia

Techno Scientific Ltd. Magnamed The Scientific Group Ltd.
Hill Lane Rua Alexandre Ferreira, 31-A P.O. Box 13119
Solferino, Phoenix 1750-010 Lisbon Vorna Valley 1686
Mauritius Portugal South Africa
Tel.No.: +230 424 1881 Tel.No.: +351-21 352 45 39 Tel.No.: +27-11-652-4000

Nigeria Reunion South Africa

QDT Solutions Nigeria Techno Scientific Ltd. The Scientific Group Ltd.
5th Floor, Hill Lane P.O. Box 13119
191 Herbert Macaulay Way Solferino, Phoenix Vorna Valley 1686
Yaba, Lagos Mauritius South Africa
Nigeria Tel.No.: +230 424 1881 Tel.No.: +27-11-652-4000
Tel.No.: +44 7808 589 217

Art: 716144-01B Rev. Date: 01/25/05

 Swaziland Tanzania Zambia
The Scientific Group Ltd. The Scientific Group Ltd. The Scientific Group Ltd.
P.O. Box 13119 P.O. Box 13119 P.O. Box 13119
Vorna Valley 1686 Vorna Valley 1686 Vorna Valley 1686
South Africa South Africa South Africa
Tel.No.: +27-11-652-4000 Tel.No.: +27-11-652-4000 Tel.No.: +27-11-652-4000

Zimbabwe
The Scientific Group Ltd.
P.O. Box 13119
Vorna Valley 1686
South Africa
Tel.No.: +27-11-652-4000

Asia/Pacific
Australia Brunei China
Abbott Point of Care Transmedic Heal Force Development, Ltd.
P.O. Box 394 60 B Martin Road #12-03 32/F Sunshine Plaza,
North Ryde TradeMart 353 Lockhart Road,
NSW 2113 Singapore 239067 Wan Chai,
Australia Tel: 65 6737-1945 Hong Kong
Tel: 800-816-696 Fax: 65 6737-3110 Tel: 852 (2898) 7303
Fax: 852 (2897) 5434

Hong Kong India Indonesia

Bio-Asia Diagnostics Co. Ltd. Span Diagnostics, Ltd. Transmedic
Unit 1010, 10/F 173-B, New Industrial Estate 60 B Martin Road #12-03
New Kowloon Plaza Road No. 6-G, Udhyognagar TradeMart
38 Tai Kok Tsui Road Udhna – 394 210 (Surat) Singapore 239067
Kowloon India Tel: 65 6737-1945
Hong Kong Tel: 91 261 2277143 Fax: 65 6737-3110
Tel: 852 (9833) 3999 Fax: 91 261 2279319
Fax: 852 (2787) 9660

Japan Korea Malaysia

FUSO Pharmaceutical POC Korea, Ltd. Transmedic
Industries, Ltd. EunKwan 603 SAG Bldg. 60 B Martin Road #12-03
2-3-11, Morinomiya Joto-Ku 217 Yangjae-dong, Seocho-gu TradeMart
Osaka 536 Seoul 137-917, Korea Singapore 239067
Japan Tel: (82) 2-2059-8591-4 Tel: 65 6737-1945
Tel: (81) 669691131 Fax: (82) 2-2059-8595 Fax: 65 6737-3110
Fax: (81) 669620173

New Zealand Philippines Singapore

Abbott Point of Care Transmedic Transmedic
P.O. Box 394 60 B Martin Road #12-03 60 B Martin Road #12-03
North Ryde TradeMart TradeMart
NSW 2113 Singapore 239067 Singapore 239067
Australia Tel: 65 6737-1945 Tel: 65 6737-1945
Tel: 800-816-696 Fax: 65 6737-3110 Fax: 65 6737-3110

2 Art: 716144-01B Rev. Date: 01/25/05

 Taiwan Thailand
Evermedical Co., Ltd. Prime Medical
6Fl., No. 379, Chuan Chin Rd. 111 Ladprao Road
Taipei 110, Soi 126
Taiwan, R.O.C. Wangthonglang, Bangkok 10310
Tel: 886-2-2723-2822 Thailand
Fax: 886-2-2722-1054 Tel: 662 934-2160
Fax: 662 934-2178

Europe
Armenia Austria Azerbaijan
Advanced Medical Technologies & Eumedics GmbH Advanced Medical Technologies &
Service Ltd. Linzer Strasse 45 Service Ltd.
(AMTS) A-3002 Purkersdorf (AMTS)
21 Lubliana St. Austria 21 Lubliana St.
Tbilisi 0159 Tel.No.: +43 2231 643 10-0 Tbilisi 0159
Georgian Republic Georgian Republic
Tel.No.: +995 325 320 36 / 32 Tel.No.: +995 325 320 36 / 32

Belarus Belgium Bosnia-Herz.

JV Diamedica Abbott Point of Care Mark s.r.l.
70 Bogdanovicha St. Parc Scientifique, Rue du Bosquet Via San Michele 334
Minsk 220100 2 34170 Gorizia
Belarus B-1348 Ottignies / Louvain-la- Italy
Tel.No.: +375 172 391 896 Neuve Tel.No.: +39 0481 21711
Belgium
Tel.No.: +32 104 753 11

Croatia Cyprus Denmark

Mark s.r.l. Santair S.A. Abbott Point of Care
Via San Michele 334 Agamemnonos 41 Smakkedalen 6
34170 Gorizia Dafni 2820 Gentofte
Italy Athens, 17235, Denmark
Tel.No.: +39 0481 21711 Greece Tel.No.: +45 39 77 00 00
Tel.No.: +210 971 4444

Finland France Georgia

Abbott Point of Care Abbott Point of Care Advanced Medical Technologies &
Pihatörmä 1 A 12, Rue de la Couture Service Ltd.
FIN-02240 ESPOO BP 50203, 94518 Rungis Cedex (AMTS)
Finland France 21 Lubliana St.
Tel.No.: +35 897 518 418 Tel.No.: +33 145 602 500 Tbilisi 0159
Georgian Republic
Tel.No.: +995 325 320 36 / 32

Germany Greece Italy

Abbott Point of Care Santair S.A. Burke & Burke S.p.A.
Max-Planck-Ring 2 Agamemnonos 41 16146 Genova
D-65205 Wiesbaden – Delkenheim Dafni Piazza Leonardo da Vinci 1
Germany Athens, 17235, Italy
Tel.No.: +49 6122 580 Greece Tel.No.: +39 (02) 458 5778
Tel.No.: +210 971 4444

Malta Netherlands Norway

Biodevices Ltd. Abbott Point of Care Abbott Point of Care
60, Independence Avenue Siriusdreef 51 Martin Linges Vei 25
Mosta MS 12 2131 WT Hoofddorp Postboks 1
Malta Postbus 727 2130 N 1330 Fornebu
Tel.No.: +356 21 421 497 Netherlands Norway
Tel.No.: +31 235 544 500 Tel.No.: +47 (0) 815 59 920

Art: 716144-01B Rev. Date: 01/25/05 3

 Poland Portugal Russia
Dutchmed PL Sp.z.o.o Magnamed ZAO Service Instrument Plus
Ul. Szajnochy 14 Rua Alexandre Ferreira, 31-A 59-2 Bolshaya Ordynka Str.
85-738 Bydgoszcz 1750-010 Lisbon 113184 Moscow
Poland Portugal Russia
Tel. No.: +48 52 345 31 15 Tel.No.: +351-21 352 45 39 Tel.No.: +7-095928-7845

Slovenia Spain Sweden

Mark s.r.l. MCInfotecnica Abbott Point of Care
Via San Michele 334 Pol Ind. Las Nievesa Box 509
34170 Gorizia C/Puerto Canencia, 21 SE-16929 Solna
Italy 28935 Mostoles, Madrid Sweden
Tel.No.: +39 0481 21711 Spain Tel.No.: +46 85 46 56 700
Tel.No.: +34 91 616 9360

Switzerland Turkey United Kingdom

AXONLAB AG Ata Medical Ticaret Ltd. Stil Abbott Point of Care
Taefernstrasse 15 Perpa Ticaret Merkezi Abbott House
CH-5405 Baden-Daetwil B.Blok, Norden Road
Switzerland Kat: 2 No. 85 Maidenhead, SL6 4XF
Tel.No.: +41 56 484 8080 Okmeydani United Kingdom
Istanbul 80270 Tel: +44 1628 784 041
Turkey
Tel.No.: +90 212 222 3458

Latin America
Argentina Brazil Colombia
Corpomedical S.A CNPH Arrow Medical de Occidente S.A
Larrea 769. Rua Gama Cerqueira, 331 Calle 33 # 65C-17
CP 1030 Cambuci - CEP 01539-010 Oficina 101
Capital Federal Sao Pablo, Brazil Medellin - Colombia
Argentina Tel: (5511) 3272-9339 Tel: (574) 351-3672
Tel: (5411) 4961-1885 Fax: (5511) 3207-9607 Fax: (574) 235 1062
Fax: (5411) 4963-8846

El Slavador Guatemala Honduras

Interserv S.A de C.V Farmed ProdyLab
Final 65 Avenida Sur Nº 249 8 Av. 2-01 Zona 10 8 Ave. Nº 445 Calle Barrio
Colonia Roma Edificio Apolo Guamilito
San Salvador Ciudad de Guatemala Local #1 . Edificio Plaza
El Salvador Guatemala Guamilito,
Tel: (503) 224-0874 or 224-0883 Tel: (502) 2361-4141 San Pedro Sula , Cortés, Honduras
Fax: (503) 243 2839 or 245-4117 Fax: (502) 2331 5565 C.A
Tel: (504) 557-3850
Fax: (504) 550-3091

4 Art: 716144-01B Rev. Date: 01/25/05

 Mexico Panama Peru
Especialidades Cientificas de Bio-Lab S.A Biomedical Systems
Laboratorio Calle 22 -Pueblo Nuevo Av. Andrés Razuri 175
Domingo Diez 1589-109 Ciudad de Panama Urb. Maranaga, San Miguel
Plaza Corporativa Apartado Postal 6-1900 Lima , Peru
Cuernavaca, Morelos El Dorado - Panama Tel: (511) 578-7265
Mexico - 62250 Tel: (507) 229 7111 Fax: (511) 578-7323
Tel: (52) 777 311 2323 Fax: (507) 229 6424
Fax: (52) 777 311 4033

Venezuela
Corporacion Diagno Imagen
Urb El Rosal. AV Venezuela
Edif Venezuela - Piso 2
Oficina 22. Caracas
Tel: (58212) 953 0729 / 953-7137
Fax: (58212) 953 4585

Middle East
Israel Jordan Kuwait
Trupharm Marketing 1985 Ltd. Israa Consulting & Trading Corp. Bader Sultan & Bros. Company
Poleg Industrial Park Odeh Commercial Building Sultan Ben Essa Building
Industrial Zone 10, Ahmad Dhaher St., 1st Floor, Dajeej Area
South Netanya Um Utheina South, Amman, 6th Ring Road,
Israel Jordan Kuwait
Tel.No.: +972-9 885 1451 Tel.No.: +962 6 552 6660 Tel: +965 433 2555

Oman Saudi Arabia U.A.E.

Waleed Pharmacy L.L.C Medical Supplies & Services Co. Gulf and World Traders
P.O. Box 437 Ltd (MEDISERV) Belhoul Group
Muscat 113 P.O. Box 17550 Garhoud
Sultanate of Oman Riydah 11494 Opposite DHL Office
Tel.No.: +968-594-766 Kingdom of Saudi Arabia 5527 Dubai
Tel.No.: +966 1 461 6999 U.A.E.
Tel.No.: +971-4-2821717

Yemen
Griffin Ltd.
Villa No. 8
Street 16, Diplomatic Area
Sana’a
Yemen
Tel.No.: +967 1 440 625

Veterinary Market – Europe

HESKA AG
Grand Places 16, CH-1700
Fribourg
Switzerland
Tel: 41 263472140
Fax: 41 263472141

Veterinary Market – USA and Rest of World

HESKA Corporation
2601 Midpoint Drive, Suite D
Fort Collins, CO USA 80525
Tel: 888-437-5286
Fax: 970-407-1477

Art: 716144-01B Rev. Date: 01/25/05 5

6 Art: 716144-01B Rev. Date: 01/25/05