iSTAT System Manual re /? i-STAT Corporation, 104 Windsor Center Drive, East Windsor, NJ 08520 (800) 827-7828 Technical Service (800) 366-8020 151530 H.3 June 1998 ©2001 i-STAT Corporation. All rights reserved. Printed in USA.OPERATING INSTRUCTIONS TABLE OF CONTENTS INTRODUCTION Page System OVEIVIEW nnesnninnininnnnntnnn 12 Intended Use. : 1-2 Implementation... snmenannnnenrnnmenreel 2 ‘Warranty... se 13 SYSTEM COMPONENTS Handheld Analyzer... Cartridge .. HP Blood Analysis Module Electronte Simulator. IR Link.. Portable Printer... Central Data Station... SAMPLE COLLECTION Specimen Collection Es Sample Transfer Devices... 3 OPERATING PROCEDURES Handheld Analyzer, Blood Analysis Module, and Cartridge .. Description of Displayed Results.. Portable Printer... Introduction to the Central Data Station QUALITY CONTROL OVEEVIEW von . Validating the Performance of the LSTAT Syste Daily Procedures... . Control and Calibration Ver ation Fluids ROUTINE CARE, TROUBLESHOOTING & TECHNICAL INFORMATION Routine Care of the Handheld Analyzer . Handheld Analyzer Tioubleshooting, Analyzer Coded Messages. Cartridge Troubleshooting Routine Care of the Portable Printer Portable Printer Troubleshooting... THEORY Analyzer Functions Electrochemical Measurements... INDEX Revision: June 1998}STAT Exhibit A License Agreement “The software in this computer is licensed to the authorized user of this computer under a sub-license from ESTAT to the user. -STAT has used the software in the computer under licenses from other original portions of software provider. By accepting and using this computer, 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 engineet 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 ‘manual and all copies thereof in the uset/licensee's possession.” 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 practicable 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 ESTAT 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. Copyrights Portions of the Central Data Station software, Copyright ©1993 MITech Inc. Patents CA 1,303,175; TW NI-36550; US 4,954,087; US Des. 332,833; TW NI-53285; US 5,112,455; US 5,124,661; US 4,864,229; US 5,096,669; CA 1,281,072; ‘TW NI-41000; US 4,933,048; US 5,200,051; CA 1,342,975; US 5,008,616; US Des. 337,164; US 5,212,050; CA 1,330,888; TW NI-65078; US 5,466,575 EP 0434742; JP 2113412; US 5,605,664; US 5,514,416; US 5,609,824; US 5,554,339; US 5,514,253. ‘Trademarks i-STAT is a registered trademark of iSTAT Corporation, Princeton, NJ 08540 USA. Kodak and Ektachem are trademarks of Eastman Kodak Company, Rochester, NY 14650 USA. ‘CrossTalk is a registered trademark of Digital Communications Associates, Inc. IBM is a registered trademark of International Business Machines Corporation. Lotus is a registered trademark of Lotus Development Corporation. ‘TurboCom is a trademark of Bio-Engineering Research Laboratories, Ashland, Oregon (High speed Windows data transfer accomplished with TurboCom driver). ‘Vacutainer is a registered trademark of Becton-Dickinson, Rutherford, NJ 07070 USA. SYNCHRON is a registered trademark of Beckman Instruments, Inc., Brea, CA 92621 USA. STAT Profile is a registered trademark of NOVA Biomedical, Waltham, MA 02254 USA. Revision: June 1998INTRODUCTION THE i-STAT SYSTEM ‘The {-STAT® System incorporates a comprehensive group of components needed to perform blood analysis at the point of care. Just 2-3 drops of fresh whole blood is all that is required, and a portable, battery-powered Analyzer or Hewlett-Packard patient monitor (with a Blood Analysis Module installed) displays quantitative test results in approximately 2 minutes, 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 recordkeeping and billing i-STAT System Components: + Cartridges ‘+ Handheld Analyzer + Hewlett-Packard Blood Analysis Module (used in conjunction with a HP patient monitor) + Portable Printer + Quality Assurance Materials Electronic Simulator Control Solutions Calibration Verification Set * Central Data Station IR Link ‘Computer Printer LiS/HIS Interface Software - AME (terminal emulation interface) ~ASIM ‘The selection of system components is dependent on factors unique to each facility such as: number of testing sites, distance between testing sites, number of tests performed per site, number of operators to be certified to use the system, and recordkeeping requirements. ‘Note: The /-STAT handheld analyzer and HP Blood Analysis Module essentially have the same features and perform the same basic functions, although some elements of the Blood Analysis Madule’s user interface have been appropriately adapted for 2 patient ‘monitoring environment. In the interest of simplicity, when operating instructions oF references apply to bath pieces of equipment throughout this manual, they will be collectively referred to as “Analyzer Revision: June 1998INTRODUCTION. SYSTEM OVERVIEW To perform testing the operator fills a cartridge with sample, seals the cartridge with its snap closure, and inserts the cartridge into the Analyzer. Insertion of a cartridge activates the Analyzer. The single-use cartridge contains calibrating solution, a sample handling system and all the sensors for a panel of tests. The Analyzer automatically controls all steps in the testing cycle including fluid movement within the cartridge, calibration, continuous quality monitoring, and thermal control (for tests where this is required), This degree of automation, along with the ability to test fresh whole blood, eliminates many sources of ertor as well as time consuming and costly steps inherent in other methods, During the testing cycle, operator and patient identification numbers can be entered. When the testing cycle is completed, results are displayed and the test record is stored, ‘The test record can be transmitted to the Central Data Station where it 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 without entry into the Central Data Station, INTENDED USE The STAT handheld analyzer and Hewlett-Packard Blood Analysis Module are intended for use with STAT cartridges for the ir vitro quantification of various analytes in human whole blood. The i-STAT System should be used by health care professionals trained and certified to use the system and should be used according to the facility's policies and procedures. IMPLEMENTATION An i-STAT representative will assist in the implementation of the system and training of resource personnel, There are no special site requirements for the i-STAT System, See the index to locate the specific procedures requited to use each component of the system: Handheld Analyzer Install batteries and check date and time on the Status page. Use the Electronic Simulator to verify the performance of new or repaired Analyzers. HP Blood Analysis Module The Hewlett-Packard Blood Analysis Module is sold and serviced by Hewlett-Packard Company. Contact yout HP representative for informati about implementation requirements for the Blood Analysis Module, Portable Install batteries, attach the printer to the IR Link or Printer Cradle and load paper. inter Revision : June 1998Central Data Station ‘The Central Data Station computer and printer require a table top space of approximately 24 x 18 inches and two power outlets. handheld analyzers transmit results through IR Links to the Central Data Station via cable. An STAT representative will assist each facility to determine cabling needs. See the index to locate the procedure to connect the IR Link to the computer. Connect the keyboard, monitor, printer and mouse (if applicable) to the ‘computer according to the computer manual. The vents of the computer should not be blocked. The work area should be free from extreme heat, dust, direct sunlight, strong magnetic fields (such as a defibrillator), liquids and cortasive chemicals. Install printer paper and ink cartridge according to the printer manual, ‘The instructions for configuring the computer and printer are covered in the Central Data Station section of this manual, Interfacing ‘The Central Data Station can be interfaced to Laboratory Information Systems (LIS) and/or Hospital Information Systems (HIS) to automate billing and patient recordkeeping. i-STAT will install an AME (Automated Manual Entry) interface tailored to the individual information transfer needs of each facility. Each AME interface is described in a customized AME User's Guide. The AME interface requires no corresponding software installation from the LIS or HIS vendor. A two way protocol conforming to ASTM standards for LIS interfaces is also available but requires prior development and installation of the interface by the LIS/HIS vendor. WARRANTY STAT Corporation warrants that representations made for products which it distributes reflect the manufacturers’ representations to i-STAT Corporation. i-STAT Corporation warrants the original purchaser Its manufactured products (excluding disposable or consumable supplies) to be free from defects in materials or workmanship for one year from the original date of, purchase subject to these terms and conditions: Returns will not be accepted without authorization from an i-STAT Representative, and products must show no evidence of improper handling or operation, including unauthorized repairs and/or damage caused by batteries. At its option, STAT Corporation may repair or replace defective products covered by this warranty. i STAT Corporation expressly disclaims all other warranties, whether express, implied, or statutory, including the warranty of merchantability and fitness of use. In no event will STAT Corporation be liable for consequential damages arising out of the use of its products. iSTAT Corporation offers a "Comprehensive Service Plan” which includes extended warranty, software upgrades, and a replacement program for loss resulting from theft or damage on certain components. Ask your I-STAT Representative for details, ‘The Hewlett-Packard Blood Analysis Module is sold and serviced by Hewlett-Packard Company. Contact your HP representative about warranty information for the Blood Analysis Module. Revision: June 1998 NOiLViWOUNI AINVEVAA Notes Warranty Cards for the optional printers should bbe completed and mailed to the designated address—not to i-STAT. Warranty information on the Central Date Station computer will be Sent by the manufacturer under separate cover. 1aRevision: June 1998SYSTENM/ COMPONENTS: Anfared Light-Emitting Diode Display ‘secon HANDHELD ANALYZER ‘The i-STAT handheld analyzer is used in conjunction with -STAT cartridges for the simultaneous quantitative determination of specific analytes in whole blood. Specifications Dimensions: Width 6.41 cm (2.52") Length 20.97 em (8.26") Depth 5.21 em (2.05") Weight: 520 grams (18.34 02) Power: ‘Two 9 volt lithium batteries (see specifics below) Calibration: Factory (electronic, mechanical, thermal, pressure) Memory/Clock Back-up Power Lithium battery Display: Dot matrix supertwist liquid crystal Communication Link: Infrared light-emitting diode Operating Temperature: 16-30BC (61-86PF) Transport Temperature: -10-SOPC (14~122PF) Relative Humidity: 0-65% (minimum) noncondensing, Barometric Pressure: 300-1000 mmHg Software All analyzer functions are contralled by software that can be updated as additional tests and features are developed. Power ‘The analyzer is powered by two 9 volt batteries. A minimum of 250 uses can be expected before replacement; overall uses for a set of new batteries is dependent on cartridge type (cartridges that require thermal controt consume power at a faster rate because of Keating). The analyzer will indicate when battery replacement is needed with a message on the display screen. ‘The battery compartment is accessed through a door on the underside of the analyzer. A separate lithium battery internal to the analyzer maintains the clock/calendar and stored results, This battery should last for seven years. ‘The analyzer has no on/off switch, It is automatically activated when a cartridge is inserted, The analyzer automatically deactivates after 45 seconds of inactivity. Pressing the display key activates the display screen for viewing results and accessing the menu. Cartridge Port ‘The cartridge containing a sample is inserted into the analyzer through the cartridge port. When properly inserted, the cartridge activates the analyzer. Revision : June 1988Infrared Light-Emitting Diode The infrared light-emitting diode (LED) transmits test records from the analyzer to a receiver on an IR Link, which can be connected to a portable printer and/or a Central Data Station computer. Connector When activated, the enalyzer makes electrical contact with a cartridge or the Blectronic Simulator by bringing an internal connector down upon the contact pads in the cartridge or Electronic Simulator. The connectot locks the cartridge in the analyzer during the testing cycle as indicated by the LCK prompt on the display screen Thermal Control and Barometric Pressure Sensor Subsystems The handheld analyzer contains a thermal control subsystem with thermistors and heating contact wires. It controls the temperature of the zone in the cartridge which contains the silicon chips, sensors and fluids that come into contact with the sensors to 37PC. This function is activated automatically when a cartridge containing tests which require thermal control at 37PC is inserted into the analyzer. ‘The analyzer also contains a solid state barometric pressure sensor which determines ambient atmospheric pressure used for the PO, sensor calibration. Test Cycle ‘The test cycle is initiated by the insertion of a cartridge into the analyzer. During the test cycle the following functions are performed by the analyzer: + electrical contact is made with the cartridge + cartridge type is identified * calibration fluid is released to the sensors + barometric pressure is measured (when tests that require thermal control are present) + sensors are heated to 37PC (who tests that require thermal control are present) * electrical signals generated at the sensors are measured * calibrant solution is displaced with sample + electrical signals generated at the sensors are measured. * operator and patient ID numbers are accepted + blood gas and patient parameters are accepted * results are calculated and displayed * results are stored Revision: June 1998 ‘SIN3NOdWOD W3ISAS If the analyzer detects the failure of @ quality check during the testing cycle, the cycle is halted and & message identifying the condition and action to be taken is displayed, 23ad Storage of Results The results of all tests are stored automatically. The analyzer can store SO test records. A test record consists of a set of results, the operator and patient identification number entered by the operator, blood gas parameters entered by the operator (when applicable), the date and time the test was performed, the serial number of the analyzer, the number of times the analyzer has been used, and the software version that is installed in the analyzer. Quality check codes that may appear during the test cycle that indicate a detected problem with the sample, calibrant solution, sensors, ‘mechanical or electrical functions of the analyzer are also stored. Stored test records are accessed through the Stored Results option on the Ment age described later in this section. Display Screen ‘Test results, operator prompts, and other messages are displayed on the handheld analyzer screen. keypad There are 15 labeled keys and two smaller unlabeled keys (soft keys) located directly below the display screen: Dis The display key is pressed to activate the display screen in order to recall the most recently displayed test results to the screen or to access the Menu page. ENT ‘The ENT (enter) key is pressed in response to a prompt on the display screen to complete an action, such as entering an operator ot a patient identification number. CLR The CLR (cleat) key is pressed to erase an incorrect number when entering an identification number. Pressing the CLR key backs the cursor (flashing blank) ‘one space and erases the number in that space. Numbered The “0” through "9" keys are used to enter operator and patient identification numbers, to change the time and date, and to make selections from menu options. PRT The PRT (print) key is pressed to send selected test records from the analyzer to the portable printer. The printer will automatically print out the test records when the PRT key is pressed. ‘ ‘The * key has several functions. It serves as a decimal when entering blood gas parameters; it is pressed to send a set of displayed results (test record) to the Central Data Station; exit a page and return to the results page when indicated by the prompts at the bottom of the screen; stop transmission of test records, from the analyzer to the portable printer as indicated by the PRINTING...* (STOP) prompt Revision : June 1998