ACE Alera™ Clinical Chemistry System

Operator’s Manual

P/N 701298 Rev 2/05

Revision History
Manual Version Revision Date
1.0 November 2004
1.1 December 2004
1.2 February 2005

Company Locations
USA
Alfa Wassermann Diagnostic Technologies, LLC.
4 Henderson Drive, West Caldwell, NJ 07006
Phone: +1-973-882-8630 or 1-800-220-4488
Fax: +1-973-276-0383
web site: www.AlfaWassermannUS.com

International
Alfa Wassermann B.V.
Pompmolenlaan 24, 3447 GK Woerden, The Netherlands
Phone: +31 348 487 300
Fax: +31 348 433 000
email: [email protected]

Copyright and Trademarks

Copyright© 2004 Alfa Wassermann, Inc. All rights reserved. This material may not be
reproduced or copied, in whole or in part, without the written permission of Alfa
Wassermann, Inc.
ACE Alera? is a trademark of Alfa Wassermann, Inc.
GEMCAL? is a trademark of Alfa Wassermann, Inc.
Vacutainer® is a registered trademark of Becton, Dickinson and Company.
Hemogard? is a trademark of Becton, Dickinson and Company.
Teflon® is a registered trademark of E. I. DuPont de Nemours and Company.
Parafilm® is a registered trademark of American National Can Company.

ii P/N 701298 Rev 2/05

WARRANTY
WARRANTY, TRAINING AND INSTALLATION
The following warranty is given expressly and in place of all other warranties, expressed
or implied (either in fact or by operation of law), statutory or otherwise, including
warranties as to merchantability or fitness which are expressly excluded, and is the only
warranty given by seller.
A. SYSTEMS
Seller warrants that at the time of delivery, new purchased equipment will be free from
defects in material and workmanship and will be in good working condition. If no post
warranty service is contracted from seller, there is a one year warranty for new
equipment, or six months for refurbished equipment, commencing upon acceptance of
the system(s) by user, as shown in the installation/checkout report for each system,
provided buyer effects the physical installation of the system(s) in accordance with the
seller’s published maintenance and operation protocols, as contained in the Operator’s
Manual. Seller shall make available to buyer its training course(s) covering the
system(s) in accordance with such conditions and schedules of charges as are then in
effect. Buyer is responsible for attending such courses.
B. PARTS AND LABOR
Service and user replaceable parts are warranted to be free of defects in material and
workmanship, and if reconditioned to be equivalent to new in performance. Seller
warrants that services performed will be done in a workmanlike manner and shall
conform to industry standards.
C. CONSUMABLES
Consumables and expendable parts, as defined in the current seller product catalog,
are warranted to be free of defects in material and workmanship at the time of
shipment.
D. REAGENTS, CALIBRATORS AND CONTROLS
Seller warrants purchased reagents, calibrators and controls to be free of defects in
material and workmanship at the time of shipment, and provided seller’s storage
instructions are strictly adhered to, seller warrants the performance of dated reagents,
calibrators and controls until the expiration date appearing on the container.
E. LIMITATION OF REMEDY
Seller shall have no liability for any direct, incidental or consequential damages resulting
from breach of warranty, from the breach or nonperformance of any term or condition
hereof or from seller’s actual or imputed negligence. In the event of any such breach,
nonperformance or negligence, seller’s liability shall be limited; (I) In the case of
equipment, to repairing or replacing (with a new component or one equivalent to new in
performance) any component which seller finds to be defective in material or
workmanship at seller’s option either at user’s installation site or at a seller facility
designated by seller (shipment to such facility to be at seller’s expense if seller finds the
component to be defective in material or workmanship); (II) In the case of labor invoiced
in connection with repairs, at seller’s election, to correcting any workmanship which
seller finds have been defective, or refunding to user the labor repair charges paid to
seller; (III) In the case of consumables, to replacing any item which seller finds to be

P/N 701298 Rev 2/05 iii

 defective in material or workmanship; (IV) In the case of reagents, calibrators and
controls, to replacing any reagents, calibrators and controls which seller finds to be
nonconforming; (V) In the case of licensed software, to correcting or modifying such
software (by providing a replacement tape, disk or article of firmware) which seller finds
to be nonconforming to specifications.
F. GEOGRAPHICAL LIMITATIONS
Non-transferability; Inconsistent Language. This warranty does not apply to equipment,
so long as it is located outside of the 50 states and the District of Columbia. Service will
not be performed outside of such geographical area except on payment of locally
applicable service charges. In the case of equipment located outside of such
geographical area which is returned (in whole or in part) to a seller facility within the
United States for warranty service, the transportation costs incurred in such return shall
be at buyer’s expense. This warranty is not transferable and may not be supplemented
or amended except in writing referring specifically hereto and signed by buyer and
seller. Without limiting the generality of the foregoing, any inconsistent language
contained in requests for quotation, buyer’s purchase orders, shipping instructions or
similar documents is specifically rejected by seller.
G. RE-USE OF CUVETTES
Seller does not endorse, recommend or support the practice of washing and recycling
cuvettes. Failure to discard ACE cuvettes after a single use is against manufacturer's
guidelines and thus invalidates ACE reagent assay performance claims, the warranty
for consumable and expendable parts, and the ACE Extended Warranty and Service
Contract agreements.

iv P/N 701298 Rev 2/05

Table of Contents
1 INTRODUCTION ..................................................................................................... 1
1.1 Intended Use ............................................................................................... 1
1.2 System Overview ......................................................................................... 1

2 DESCRIPTION ........................................................................................................ 3
2.1 Analysis Module........................................................................................... 4
2.1.1 Fluid Transport System .................................................................... 4
2.1.2 Sample/Reagent Module .................................................................. 5
2.1.3 Sample Tube Entry Port (STEP)....................................................... 6
2.1.4 Syringe Module ................................................................................ 6
2.1.5 Temperature Control System............................................................ 7
2.1.6 Reaction Wheel................................................................................ 8
2.1.7 Cuvette Hopper ................................................................................ 8
2.1.8 Optical System ................................................................................. 8
2.1.9 Liquid Level Sensing System............................................................ 9
2.1.10 System Sensors ............................................................................. 9
2.1.11 CPU Interface Board ...................................................................... 9
2.1.12 Motors .......................................................................................... 10
2.1.13 ISE Module (Optional) .................................................................. 11
2.2 Uninteruptible Power Supply/Line Conditioner ........................................... 11
2.3 Consumables............................................................................................. 12
2.3.1 Cuvettes......................................................................................... 12
2.3.2 Seglets ........................................................................................... 13
2.3.3 Sample Cups.................................................................................. 14
2.4 Reagents, Calibrators and Controls ........................................................... 15
2.4.1 Chemistry Reagents....................................................................... 15
2.4.2 Chemistry Calibrators..................................................................... 15
2.4.3 Controls.......................................................................................... 15
2.4.4 ISE Reagents and Calibrators ........................................................ 16
2.4.5 System Diluent ............................................................................... 16
2.5 Integrated Computer Workstation............................................................... 17
2.5.1 Computer ....................................................................................... 17
2.5.2 Keyboard........................................................................................ 17
2.5.3 Printer ............................................................................................ 18
2.5.4 LCD Monitor................................................................................... 19
2.6 Menus........................................................................................................ 20
2.6.1 Selecting a Menu Command .......................................................... 20
2.6.2 Navigating Through Menus ............................................................ 20
2.6.3 Main Menu ..................................................................................... 21
2.6.4 Requisitions.................................................................................... 22
2.6.5 Reports .......................................................................................... 23
2.6.6 Cup/Segment Placement................................................................ 24
2.6.7 Journals ......................................................................................... 24
2.6.8 Delete/Archive................................................................................ 25
2.6.9 Utilities ........................................................................................... 25
2.6.10 Diagnostics................................................................................... 26

P/N 701298 Rev 2/05 v

 2.6.11 Setup............................................................................................27
2.6.12 Status Menu .................................................................................28
2.6.13 Access Menu ................................................................................29
2.7 System Information ....................................................................................30
2.7.1 Analyzer State ................................................................................30
2.7.2 Software Version ............................................................................30
2.7.3 User Access ...................................................................................30
2.8 Specifications .............................................................................................31

3 PRINCIPLES OF OPERATION..............................................................................35
3.1 Operational Sequence Overview ................................................................35
3.1.1 Task Scheduling .............................................................................35
3.1.2 Priority of Instrument Activities........................................................36
3.1.3 Analysis Sequence .........................................................................37
3.1.4 Monitoring System Resources ........................................................37
3.1.5 Calibration of Photometric Tests .....................................................37
3.1.6 Calibration of Potentiometric (ISE) Tests ........................................38
3.1.7 Curve Correction.............................................................................39
3.1.8 Calibrator Averaging .......................................................................39
3.1.9 Response Calculation.....................................................................40
3.1.10 Result Calculation.........................................................................40
3.1.11 Routine Chemistry Equations........................................................41
3.1.12 Running Tests ..............................................................................43
3.1.13 Integrity Checks............................................................................43
3.1.14 Automatic Sample Rerun ..............................................................46
3.1.15 Result Correlation.........................................................................46
3.1.16 Reporting Results .........................................................................47
3.2 Operational Precautions .............................................................................48
3.2.1 General Precautions .......................................................................48
3.2.2 Additional ISE Module Precautions.................................................49

4 SYSTEM SETUP....................................................................................................51
4.1 Materials.....................................................................................................51
4.1.1 Materials Provided ..........................................................................51
4.1.2 ISE Parts ........................................................................................52
4.1.3 Materials Provided at Installation ....................................................52
4.2 Positioning and Connecting the Modules....................................................53
4.2.1 Site Selection..................................................................................53
4.2.2 Physical Dimensions and Space Requirements..............................54
4.2.3 Electrical Service ............................................................................55
4.2.4 Positioning of Modules....................................................................55
4.2.5 Connecting the Modules .................................................................55
4.3 Software Installation ...................................................................................56
4.3.1 Re-Loading the Operating Software................................................56
4.3.2 Re-Loading the Setup Information ..................................................57
4.4 Container Installation..................................................................................57

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 4.5 ISE Installation........................................................................................... 58
4.5.1 Enabling the ISE Module ................................................................ 58
4.5.2 Installing the ISE Tubing................................................................. 58
4.5.3 Electrode Installation ...................................................................... 71
4.5.4 ISE Reagents ................................................................................. 73
4.5.5 Liquid Sensor Calibration ............................................................... 75
4.5.6 Cleaning, Conditioning and Calibration........................................... 75

5 DAILY PREPARATION FOR OPERATION........................................................... 77

5.1 Daily Maintenance ..................................................................................... 77
5.2 Checking Status......................................................................................... 78
5.2.1 Power............................................................................................. 78
5.2.2 Checking Reagent Tray Status....................................................... 78
5.2.3 Checking Calibration Status ........................................................... 80
5.2.4 Checking Tests On Hold................................................................. 81
5.2.5 Checking Sample Ring Status........................................................ 82
5.2.6 Checking Hopper Status................................................................. 84
5.2.7 Checking Database Status ............................................................. 85
5.3 Loading Consumables ............................................................................... 86
5.3.1 Loading the Cuvette Hopper........................................................... 86
5.3.2 Loading Clean Well Segments ....................................................... 88
5.3.3 Loading Empty Cup Segments ....................................................... 90
5.4 Loading Reagents...................................................................................... 92
5.4.1 Preparing Reagents ....................................................................... 92
5.4.2 Loading Reagents .......................................................................... 93
5.5 Replenishing Solutions............................................................................... 95
5.5.1 Accessing Solution Containers ....................................................... 95
5.5.2 Emptying System Waste ................................................................ 96
5.5.3 Replacing System Diluent .............................................................. 97
5.5.4 Replacing ISE CAL-A ..................................................................... 98
5.5.5 Replacing ISE CAL-B ..................................................................... 99
5.5.6 Replacing ISE Reference Solution ............................................... 100
5.6 Emptying the Cuvette Waste Box............................................................. 101

6 ORDERING TESTS ............................................................................................. 103

6.1 Initiating a Patient Sample Requisition ..................................................... 103
6.1.1 Initiating a Requisition for a New Patient ...................................... 104
6.1.2 Initiating a Requisition for an Existing Patient............................... 106
6.1.3 Initiating Multiple Requisitions ...................................................... 107
6.2 Ordering Tests for Patient Sample Requisitions ....................................... 109
6.2.1 Ordering Tests for a New Patient ................................................. 109
6.2.2 Adding One or More Tests to an Existing Requisition................... 111
6.2.3 Ordering a Remote (Linking) Test ................................................ 113
6.3 Modifying a Patient Requisition ................................................................ 114
6.3.1 Deleting a Test From a Requisition .............................................. 114
6.3.2 Changing Information in a Requisition .......................................... 115

P/N 701298 Rev 2/05 vii

 6.4 Creating a QC Requisition........................................................................ 117
6.4.1 Selecting a Control Requisition..................................................... 117
6.4.2 Ordering a Rerun of All Tests........................................................ 118
6.4.3 Ordering a Rerun of a Single Test ................................................ 118
6.4.4 Deleting all Current Tests ............................................................. 118
6.4.5 Ordering One or More New Tests ................................................. 119
6.5 Creating a Calibration Requisition ............................................................ 120
6.5.1 Initiating a Calibrator Requisition .................................................. 120
6.5.2 Initiating a Correction Requisition ................................................. 122

7 RUNNING TESTS ................................................................................................125

7.1 Running a Single Sample ......................................................................... 125
7.1.1 Running a Tube with a Barcode Label .......................................... 125
7.1.2 Running a Tube without a Barcode Label ..................................... 126
7.1.3 Running an Individual Sample Cup............................................... 127
7.1.4 Refilling a Short Sample Cup........................................................ 128
7.1.5 Replacing an Expired Sample Cup ............................................... 128
7.1.6 Removing an Inactive Sample Cup............................................... 129
7.1.7 Manual Rerun of Tests ................................................................. 130
7.2 Running a Batch of Samples .................................................................... 131
7.2.1 Running a Batch of Sample Cups ................................................. 131
7.2.2 Running a Batch of Sample Tubes ............................................... 133
7.3 Results ..................................................................................................... 134
7.3.1 Patient Results ............................................................................. 134
7.3.2 Quality Control Results ................................................................. 135
7.3.3 Calibration Report......................................................................... 136
7.3.4 Verifying Results........................................................................... 137
7.3.5 Entering Off-Line Results.............................................................. 138
7.3.6 Entering Calculation Test Values .................................................. 138
7.3.7 Editing Test Results...................................................................... 139
7.4 Quality Assurance .................................................................................... 140
7.4.1 Use of Quality Control Material ..................................................... 140
7.4.2 Corrective Action .......................................................................... 141
7.4.3 Precision Data .............................................................................. 141
7.4.4 Correlation Data ........................................................................... 145
7.5 Status Indicators During the Run.............................................................. 148
7.6 Stopping the Run...................................................................................... 149
7.7 Daily Shutdown ........................................................................................ 150
7.7.1 Check Fluid Levels ....................................................................... 150
7.7.2 Remove Used Sample Cups and Seglets ..................................... 150
7.7.3 Backup System............................................................................. 150
7.8 Powering Off the System.......................................................................... 150

viii P/N 701298 Rev 2/05

8 DATA MANAGEMENT ........................................................................................ 151
8.1 Types of Reports...................................................................................... 151
8.1.1 Patient Reports ............................................................................ 151
8.1.2 QC Reports .................................................................................. 152
8.1.3 Other Reports............................................................................... 153
8.2 Preparing a Patient Report....................................................................... 154
8.2.1 Single Requisition......................................................................... 154
8.2.2 Cumulative Report........................................................................ 155
8.2.3 Merged Report ............................................................................. 156
8.2.4 Archived ....................................................................................... 157
8.2.5 Review of Patient Reports ............................................................ 158
8.3 Preparing a QC Report ............................................................................ 159
8.3.1 Requisition ................................................................................... 159
8.3.2 Monthly Levey-Jennings Plots...................................................... 160
8.3.3 Individual Levey-Jennings Plots ................................................... 161
8.3.4 Including More Information in Individual Levey-Jennings Plots ..... 161
8.3.5 QC Statistics ................................................................................ 162
8.4 Preparing Other Reports .......................................................................... 163
8.4.1 Backlog Report............................................................................. 163
8.4.2 Test Counts Report ...................................................................... 164
8.4.3 Calibration Report ........................................................................ 165
8.4.4 Raw Data Report.......................................................................... 165
8.4.5 Parameters Report ....................................................................... 166
8.4.6 Performance Report..................................................................... 167
8.4.7 Journal Report.............................................................................. 168
8.5 System Backup and Restoration .............................................................. 169
8.5.1 System Backup ............................................................................ 169
8.5.2 Restoring System Data................................................................. 170
8.6 Archiving and/or Deleting Patient Files..................................................... 171
8.6.1 Archiving Patient Files.................................................................. 171
8.6.2 Restoring the Archive Log ............................................................ 172
8.6.3 Archiving and then Deleting Inactive Files .................................... 173
8.6.4 Displaying or Printing a Patient Requisition from an Archive ........ 174
8.6.5 Deleting Inactive Files without Archiving....................................... 175
8.7 Deleting Test Counts................................................................................ 176
8.7.1 Resetting All Counts..................................................................... 176
8.7.2 Resetting Individual Counts.......................................................... 177
8.8 Deleting Patient Data ............................................................................... 178
8.8.1 Deleting a Test ............................................................................. 178
8.8.2 Deleting a Requisition .................................................................. 178
8.8.3 Deleting a Patient......................................................................... 179

9 SYSTEM SETUP ................................................................................................. 181

9.1 Hardware Setup ....................................................................................... 181
9.1.1 Enabling the ISE Module .............................................................. 181
9.1.2 Setting the ISE Calibration Mode.................................................. 182
9.1.3 Enabling Laboratory Information Management System (LIMS)..... 183

P/N 701298 Rev 2/05 ix

 9.1.4 Specifying Entry of Patient First Name.......................................... 184
9.1.5 Disabling Reagent Temperature Control....................................... 185
9.1.6 Adjusting the Volume of the Audible Alarm ................................... 186
9.1.7 Specifying the Type of Barcode Scanner ...................................... 187
9.1.8 Specifying Label Symbology ......................................................... 188
9.1.9 Specifying Sample Lifetime........................................................... 189
9.1.10 Specifying Suppression of Leading Zeros in the Accession ........ 190
9.2 Test Parameters....................................................................................... 191
9.2.1 Modifying a Test Name or Mnemonic............................................ 192
9.2.2 Modifying Predilution or Auto Rerun Dilution Ratios...................... 193
9.2.3 Modifying Calculation Method Parameters.................................... 194
9.2.4 Modifying the Result Units or Decimal Places............................... 195
9.2.5 Modifying Reference Ranges........................................................ 196
9.2.6 Enabling or Disabling Quality Control Checks............................... 197
9.2.7 Creating a New Test ..................................................................... 198
9.3 Special Tests............................................................................................ 199
9.3.1 Off-Line Test................................................................................. 199
9.3.2 Derived Test ................................................................................. 200
9.3.3 Calculation Test............................................................................ 201
9.3.4 Remote Test ................................................................................. 201
9.4 Calibrators................................................................................................ 203
9.4.1 Defining Calibrators ...................................................................... 203
9.4.2 Modifying Information for a Calibrator ........................................... 203
9.4.3 Deleting a Calibrator ..................................................................... 204
9.5 Controls.................................................................................................... 205
9.5.1 Defining a New Control................................................................. 205
9.5.2 Modifying Expected Values for a Control ...................................... 206
9.5.3 Modifying the Lot Number for a Control ........................................ 207
9.5.4 Deleting a Control......................................................................... 208
9.6 User-Defined Reagent Bottles .................................................................. 209
9.7 Configuring Test Panels ........................................................................... 211
9.7.1 Defining a Panel ........................................................................... 211
9.7.2 Modifying a Panel ......................................................................... 212
9.7.3 Deleting a Panel ........................................................................... 212
9.8 Configuring the Doctor List ....................................................................... 213
9.8.1 Adding a Doctor’s Name............................................................... 213
9.8.2 Modifying a Doctor’s Name........................................................... 213
9.8.3 Deleting a Doctor’s Name ............................................................. 213
9.9 Configuring Carryover Parameters ........................................................... 214
9.9.1 Specifying a Probe Rinse.............................................................. 214
9.10 Miscellaneous Options ............................................................................. 215
9.10.1 Displaying Miscellaneous Options .............................................. 215
9.10.2 Password.................................................................................... 216
9.10.3 Reminders .................................................................................. 217
9.10.4 Facility Identification ................................................................... 218
9.10.5 Report Footer ............................................................................. 219
9.10.6 Archiving Mode........................................................................... 220
9.10.7 Setting the Date Format.............................................................. 220

x P/N 701298 Rev 2/05

 9.10.8 Setting the Accession Mode ....................................................... 220
9.10.9 Reporting Options ...................................................................... 221
9.11 Performance Screens .............................................................................. 224
9.12 Other Options........................................................................................... 224
9.12.1 Set System Date and Time......................................................... 224
9.12.2 View Software Version ............................................................... 225
9.12.3 Set System Language ................................................................ 225

10 MAINTENANCE .................................................................................................. 227

10.1 Daily Maintenance ................................................................................... 229
10.1.1 (DM-1) Remove Condensation from Reagent Compartment ..... 229
10.1.2 (DM-2) Clean Wash Bath and Probe Pathway............................ 230
10.1.3 (DM-3) Clean Exterior of Probe .................................................. 231
10.1.4 (DM-4) Check Probe Alignment.................................................. 232
10.1.5 (DM-5) Clean and Condition ISE ................................................ 233
10.2 Weekly Maintenance................................................................................ 234
10.2.1 (WM-1) Clean ISE Reference Housing ....................................... 234
10.2.2 (WM-2) Clean ISE Sample Port.................................................. 237
10.2.3 (WM-3) Inspect Air Filters and Clean if Necessary ..................... 238
10.2.4 (WM-4) Clean Exterior Surface of Instrument............................. 239
10.2.5 (WM-5) Washplate Assembly Cleaning Procedure ..................... 239
10.3 Monthly Maintenance............................................................................... 241
10.3.1 (MM-1) Rinse Probe and Fluid Lines with Bleach ....................... 241
10.3.2 (MM-2) Clean Cap Assemblies and Connectors......................... 242
10.3.3 (MM-3) Calibrate Table Offset, Sample Delay, and Optics ......... 244
10.4 Bi-Annual Maintenance ............................................................................ 245
10.4.1 (BM-1) Replace ISE Pump Tubing ............................................. 245
10.5 Unscheduled Maintenance....................................................................... 247
10.5.1 (UM-1) Replace Printer Paper .................................................... 247
10.5.2 (UM-2) Replace Printer Toner Cartridge and Drum .................... 247
10.5.3 (UM-3) Replace Probe................................................................ 247
10.5.4 (UM-4) Clean Up Spills............................................................... 249
10.5.5 (UM-5) Replace ISE Electrodes.................................................. 250
10.5.6 (UM-6) Replace ISE Peristaltic Pump Roller............................... 252
10.5.7 (UM-7) Replace Tube Piercing Device ....................................... 253
10.5.8 (UM-8) Replace Printer............................................................... 254
10.5.9 (UM-9) Long Term ISE Shutdown .............................................. 255

INDEX ........................................................................................................ 259

P/N 701298 Rev 2/05 xi

About This Manual
This manual is written for operators that use and maintain the ACE Alera Clinical
Chemistry System.

This manual gives you the information needed to:

?? Understand the system, its components, and the principles of operation
?? Understand the user interface
?? Install the system
?? Operate the system
?? Configure the system so that it best meets the needs of your facility
?? Maintain the system

xii P/N 701298 Rev 2/05

Safety Regulations
These safety regulations must always by followed when working with the ACE Alera
Clinical Chemistry System.
?? Always contact a responsible person in case of questions regarding the safe use
or operation of the ACE Alera System.
?? Use the ACE Alera System only for its intended use.
?? Know and understand how to work safely with the ACE Alera System before
starting any activities.
?? Never turn the power on to the ACE Alera System unless the electrical service
has been inspected and found to be safe.
?? Always follow the recommended procedures when turning the power on and off
to the ACE Alera System.
?? Ensure that all users of the ACE Alera System are properly supervised.
?? If an unexpected event occurs (such as excessive vibration or noise) while
operating the ACE Alera System, turn the power off immediately and contact the
responsible person.
?? Turn the power to the ACE Alera System off completely before performing
cleaning and maintenance.
?? Repair and maintenance of the ACE Alera System must only be performed by
properly qualified individuals.
?? Use only recommended materials for cleaning the ACE Alera System.
?? If any unsafe condition or operation of the ACE Alera System is observed, report
it immediately to the responsible person.
?? Never place objects on the ACE Alera System.
This product complies with the safety regulations
?? Low-Voltage Directive 73/23/EEC
?? EMC Directive 89/336/EEC
?? Machine Directive 98/37/EEC
and Standards
?? NEN-EN 1050
?? NEN-EN 292-1
?? NEN-EN 292-2
?? NEN-EN 61326
?? NEN-EN 60204
?? NEN-EN 50081-2
?? NEN-EN 50082-2

P/N 701298 Rev 2/05 xiii

Warnings
WARNING: Only qualified trained personnel should be permitted to open
the deck of the ACE Alera System.

WARNING: The ACE Alera System can be immediately stopped at any

time by turning OFF the UPS power switch.

WARNING: The front door of the ACE Alera System must be kept closed
during operation.

xiv P/N 701298 Rev 2/05

Conventions
Text Conventions
Certain text conventions are used throughout the manual:

Convention Purpose
Numbered Lists Describes each step that must be carried out in the
order given when performing an operation:

1 Turn the power ON.

2 Allow the system to warm up.

Menu Commands Designates a command that is to be selected from a

menu when performing an operation:

1 Select Requisition from the Main menu.

2 Select Patient from the Requisition menu.

Bold Typeface, Lower Case Designates one or more components of the

hardware or user interface that is being described:

The integrated computer workstation includes a

PC-compatible computer, LCD monitor and
keyboard.

P/N 701298 Rev 2/05 xv

 Symbols
Certain symbols are used throughout the manual to allow certain information to be
prominently displayed:

Symbol Purpose

?
(Information note) Designates background or additional information
that is useful in understanding the procedure or topic.

(Caution/Warning) Designates a possible hazardous situation which

may result in personal injury, death, or damage to the system if not
avoided.

(Biohazard) Designates a biohazard that must be handled cautiously

in accordance with laboratory safety practices and federal and local
regulations. Appropriate personal protective equipment (lab coat,
gloves, eye protection) should be worn when performing procedures
with biohazardous material.

Manufacturer of the system.

In-vitro diagnostic medical device.

Authorized representative in the European community.

(CE mark) The CE mark is the official marking required by the

European community for all electric and electronic equipment that will
be sold or put into service for the first time, anywhere in the European
community. It proves to the buyer or user that this product fulfills all
essential safety and environmental requirements as they are defined
in the European directives.

xvi P/N 701298 Rev 2/05

Glossary
Phrase Description
Analysis Module The component of the ACE Alera System that contains the hardware and reagents
needed to perform the tests.

BIOBAGS Disposable plastic bags displaying a biohazard label used to line the cuvette waste
box. The bag allows removal of used cuvettes from the box without direct handling
by the operator.

CAL-A, CAL-B Solutions that are used for calibrating the electrodes in the optional ISE module.

CAL-A Cap A cap and tubing assembly that is attached to the CAL-A container before it is
Assembly placed in the container compartment. The tubing contains an in-line filter.

Cup Segment A plastic device that can hold up to 15 sample cups. Samples are loaded into the
instrument by placing the segment on posts along the outer edge of the
sample/reagent tray.

Cuvette Specially designed container of optical quality plastic. Sample and reagent are
dispensed into a cuvette by the instrument in order to perform a photometric test.

Cuvette A plastic sleeve that holds 20 cuvettes. The cartridge facilitates loading the cuvettes
Cartridge into the cuvette hopper.

Cuvette Hopper A compartment in the analysis module used to store up to 200 cuvettes. Cuvettes
are added to the hopper through a slot in the top of the compartment.

Cuvette Waste Reusable metal container lined with a BIOBAG that receives used cuvettes expelled
Box from the reaction wheel.

Diluent Cap A cap and tubing assembly that is attached to the system diluent container before it
Assembly is placed in the container compartment. The tubing contains an in-line filter.

Fluid Arm Probe Stainless steel probe used to aspirate and dispense system fluids.
Assembly

Evap-Caps Adhesive backed covers that are used to minimize evaporation of reagents stored in
the sample/reagent tray.

ISE Module An optional module that measures sodium, potassium and chloride using
ion-selective electrodes.

Ion-Selective A potentiometric device used to determine the activity of sodium, potassium or

Electrode chloride by measuring the difference in electrical potential between the ion-selective
electrode and a reference electrode.

LIMS Laboratory Information Management System (or LIS, for Laboratory Information
System). A computerized system used for the storage, sorting, and retrieval of
laboratory data.

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Loadlist A group of samples that are loaded into the instrument as a batch. A loadlist can
contain up to 15 patient, control and/or calibrator samples.

Open Channel A reagent bottle that is defined by the user. An open channel bottle may be filled
Bottle with a reagent obtained from a different manufacturer. Parameters must be defined
for this reagent bottle before it can be used in testing.

Reaction Wheel The circular device inside the analysis module that holds the cuvettes used in
testing. The reaction wheel holds 48 cuvettes.

Sample/Reagent A tray located within the analysis module used to hold up to five sample segments
Tray and 40 reagent bottles. Reagent bottles are placed in openings on the tray. Cup
segments and well segments are placed on posts along the outer edge of the tray.

Seglet A group of ten sample wells that are attached as a unit. A sample that is aspirated
via the STEP is dispensed into one of the wells. The wells are also used to hold
samples that are automatically diluted during testing.

Seglet Holder See well segment.

STEP The STEP, or Sample Tube Entry Port, allows the user to load a patient sample into
the instrument directly from a primary blood collection tube via cap piercing
mechanism. The tube is placed into the STEP, lowered into the instrument, sampled
and returned. If the tube has a barcode label, an instrument equipped with an
optional barcode reader will read the label and associate the sample with the
corresponding requisition.

System Diluent Fluid used for rinsing the probe between reagent and sample transfers and diluting
samples.

UPS The UPS, or Uninterruptible Power Supply, provides the system with battery backup
for five minutes in the event of a power failure.

Waste Cap Attached to the liquid waste container.

Assembly

Waste Container Reusable plastic bottle used to receive waste fluid from the probe wash bath and
the ISE.

Well Segment A plastic device that holds three seglets totaling thirty sample wells. All three seglets
must be loaded onto a segment for proper operation. Well segments are used to
accept STEP samples or dilutions made by the system and are loaded onto the
instrument by placing on posts along the outer edge of the sample/reagent tray.

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1 Introduction

1.1 Intended Use

The ACE Alera Clinical Chemistry System is an automated bench-top random access
analyzer that is intended for in vitro diagnostic use in the quantitative determination of
constituents in blood and other fluids.
Analyses are performed using spectrophotometric measurements at 37 ?C and can be
expanded to include potentiometric measurements by the addition of an optional ISE
module. Excellent throughput, a broad test menu, routine and STAT capabilities, and
flexibility make the system well suited as a stand-alone analyzer in small facilities as well
as a reliable backup or specialty analyzer in mid to large-sized institutions.

1.2 System Overview

The ACE Alera System (Figure 1) is fully automated. An internal computer directs all
system functions including test requisitioning, analyzer operation, data acquisition, data
processing, report generation and fault monitoring.
Definitions for a wide variety of manufacturer-validated tests are included with the
system and, for added flexibility, definitions for additional tests can be entered by
individual laboratories. Up to 200 different test definitions can be maintained on the
system at one time.
System throughput is up to 165 tests per hour. STAT requests take priority over the
routine tests and may be entered at any time. Depending on the test requested, STAT
tests are completed within minutes.
Up to 40 different reagents can be used on the system at one time. The reagents are
maintained on the system at 8 ?C ± 1 ?C to maximize their on-system stability. They can
be loaded anywhere on the reagent tray, since each reagent container is positively
identified by means of a computer coded label. The liquid level of each reagent is
measured when the reagent is used and the operator is notified when a reagent is
depleted.
Samples are introduced into the system directly from primary tubes or from sample cups
filled by the operator. An optional on-system barcode reader allows positive identification
of barcoded primary tubes, while sample cups are identified by means of a worklist
prepared by the operator. The liquid level in each sample container is measured when
the sample is aspirated, and the operator is notified when there is insufficient sample for
analysis. Finally, the time each sample remains on the system is monitored and, for
quality assurance purposes, a sample is not used after it has been on the system for
more than four hours.

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Two types of sample segments are used by the system. Individual micro-sample cups
are used for samples that are poured or pipetted into sample cups. These cups are
placed in a 15-position cup segment, and the filled cup segment is loaded on the
system. Integral 30-position well segments are used for samples that are aspirated from
open and closed primary tubes and for automatic dilutions of samples. The combination
of cup segments and well segments used is based on the workload being processed,
and up to five segments can be placed on the system at one time.
During analysis, samples and reagents are pipetted into individual disposable cuvettes
contained on a 48-position reaction wheel. As each test is completed, the used cuvette
is ejected into a cuvette waste box and a new cuvette is loaded onto the reaction wheel
from the cuvette hopper. Since the reaction wheel contains 48 cuvettes and the cuvette
hopper contains 200 cuvettes, the system can run 48 tests at one time and 248 tests
before the cuvette hopper must be reloaded.
The analysis module includes a holographic diffraction grating spectrophotometer to
measure absorbance at 16 different wavelengths. Readings for each test are taken at
wavelengths and times that are preset for the particular test being run. The test results
for the sample are then calculated as specified by the test parameters.
An optional ISE module allows simultaneous potentiometric measurements for sodium,
potassium and chloride to be obtained. Readings for each test are taken at times that
are preset for the tests being run. On board calibrators provide periodic automatic
updates of calibration slopes.
Many different reports are available. Each report can be viewed on the workstation
screen or it can be printed. The system also provides a means to transmit report
information to a laboratory information management system (LIMS).

Figure 1. The ACE Alera Clinical Chemistry System

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2 Description

The ACE Alera System consists of an analysis module with an integrated computer
workstation (Figure 2). The integrated computer workstation includes a PC-compatible
computer, LCD monitor and keyboard. A printer and uninterruptible power supply
(UPS)/line conditioner are also provided.

Analysis
Module Printer

UPS/ Line Conditioner

UPS Power Switch

Figure 2. ACE Alera Clinical Chemistry System Modules

WARNING: The ACE Alera System can be immediately stopped at any

time by turning OFF the UPS power switch.

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2.1 Analysis Module

The analysis module (Figure 3) contains internal and external components.

Cuvette Hopper

LCD Monitor Reagent Tray Access Cover

STEP Fluid Arm

Keyboard Probe

Sample/Reagent Tray

ISE

Figure 3. Analysis Module

2.1.1 Fluid Transport System

The fluid transport system transfers measured amounts of sample and reagents to a
cuvette or to the ISE module.
The fluid transport system consists of the following components:

Component Function
Fluid Arm Transfers fluids and regulates fluid temperature.

Transfer Module Controls the vertical and rotational movement of the probe
and fluid arm.

Probe Enters reagent bottles, seglet wells, sample cups or tubes to

enable aspiration of proper volume. Enters cuvettes, seglet
wells, or the ISE port to dispense fluids.

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2.1.2 Sample/Reagent Module

The sample/reagent module (Figure 4) contains the sample/reagent tray. The

sample/reagent tray contains up to twenty large bottles (30 mL capacity) in the outer
openings and up to twenty small bottles (12 mL capacity) in the inner openings.
The outer edge of the reagent tray has posts for attaching well segments (page 13) or
cup segments (page 14). The well segments and cup segments contain the samples that
are to be tested.
Two optical scanner ports are located directly below the circular path of the reagent
bottles. Cameras beneath these ports read the computer-coded labels on the bottom of
the reagent bottles. The labels provide the lot number, reagent identification and
sequence number for each reagent bottle.

Figure 4. Sample/Reagent Module

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2.1.3 Sample Tube Entry Port (STEP)

Samples can be introduced to the system directly from primary tubes or from sample
cups that are filled by the operator. Primary tubes are sampled by placing them
individually into the Sample Tube Entry Port (or STEP). When the STEP is used,
sensors detect the presence of a tube and orient it to be punctured and scanned for a
barcode label if an optional barcode reader is installed.
The system detects the level of sample within the tube and withdraws sufficient sample
from the tube to complete all tests requested.

2.1.4 Syringe Module

The syringe module aspirates and dispenses precision amounts of sample, reagent
and diluent.
The syringe module consists of these components:

Component Function
Syringe Aspirates and dispenses measured quantities of sample and
reagent up to 500 µL.

Stepper Motor Drives the syringe plunger in uniform increments (1 µL)

during aspiration and dispensing.

Valve Manifold Block Controls liquid flow.

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2.1.5 Temperature Control System

Temperature is controlled in the following areas of the ACE Alera System:

Analytical Chamber
The analytical chamber uses both heating and cooling functions to maintain the strict
temperature conditions (37 ?C ± 0.3 ?C) required for sample processing.

Reagent Compartment
The temperature within the reagent compartment is monitored so that reagents are
maintained at 8 ?C ± 1 ?C.

Fluid Arm
The fluid arm prewarms fluid as it transfers it from the cold reagent compartment to the
warm analytical chamber. The temperature is regulated by means of a 20 watt heater
that is set at 42 ?C ± 0.5 ?C and bonded to the bottom of the arm. The heater is
regulated by the CPU.

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2.1.6 Reaction Wheel

The reaction wheel (Figure 5) holds a total of 48 disposable cuvettes (see page 12).
The cuvettes are automatically loaded onto the reaction wheel from the cuvette hopper.
During operation, samples and reagents are dispensed into a cuvette and mixed. The
reaction wheel (and the cuvettes) rotate, and optical absorbance measurements are
taken as the cuvette passes through the measuring station. The wavelength(s) and
times of the absorbance readings that are used in the measurement are specified in the
parameters for that test.
After the measurements for a sample are completed, the used cuvette is ejected into the
cuvette waste box and a new cuvette is inserted into that position.

Cuvettes

Figure 5. Reaction Wheel

2.1.7 Cuvette Hopper

The cuvette hopper contains up to 200 cuvettes. The cuvettes are added to the hopper
by the operator using cartridges (see page 12) containing twenty cuvettes. The
cartridges are loaded through a slot in the top of the hopper.

2.1.8 Optical System

A pulsed xenon lamp is the light source for the optical system. A holograph diffraction
grating spectrophotometer is used to measure absorbance at 16 different wavelengths.
Readings for each test are taken at wavelengths and times that are preset for the
particular test being run.

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2.1.9 Liquid Level Sensing System

When aspirating fluid, the probe receives a frequency signal from a conductive metal
plate located below the reagent bottle, segment cup or well, or in the STEP. This signal
is transferred to the fluid arm. The transfer arm CPU uses this signal to determine if the
probe is in fluid or not.

2.1.10 System Sensors

Sensors are used to monitor various system states.

Sensor Function
Cuvette Waste Bin Monitors if waste bin is in place and if it is full.

Diluent Container Recognizes when the container has fluid or is empty.

Waste Container Monitors if the container is full or not full.

Reaction Wheel Positions the reaction wheel and times the pulsing of the
xenon lamp.

Sample/Reagent Positions the sample/reagent tray.

Sample Cup Detects whether sample cups and seglets are in the correct
positions in the segments.

Segment In Place Determines if a segment is present at each post on the

sample/reagent tray and the type of segment.

Segment Cover Determines whether the cover is open or closed.

Reagent Cover Determines whether the cover is open or closed.

2.1.11 CPU Interface Board

A 80C196 microcontroller acts as the master controller of the ACE Alera System. It
controls communication between the instrument and the integrated computer
workstation.

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2.1.12 Motors

Motion of the various components within the analyzer is powered by various motors:

Motor Function
Syringe Module Motor Controls movement of displacement syringe.

Cuvette Hopper Motors Load and move cuvettes within the Hopper and eject used
cuvettes.

Sample/Reagent Tray Moves the sample/reagent tray.

Motor

Reaction Wheel Motor Moves the reaction wheel.

Fluid Transfer Module Control rotational and vertical motion.

Motors

Sample Tube Entry Port Move sample tube into position for sampling and return it to
(STEP) Motors be removed from the STEP.

Optional ISE Motor Pumps fluids to be analyzed by ISE.

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2.1.13 ISE Module (Optional)

The ISE module is an optional integrated module that measures sodium, potassium and
chloride using ion-selective electrodes. The ISE system consists of the following
components:

ISE Component Function

Measuring Chamber Contains the four electrodes.

Peristaltic Pump Transports liquids through the ISE module.

Valves Control the movement of fluid and air in and out of the
measuring chamber.

Sample Sensor Detects the aspiration of calibrating solutions, maintenance

solutions, sample and air at the proper sequence.

Tubing Transports fluids and air in and out of the measuring

chamber.

Sodium Electrode Measures sodium by means of a glass capillary and a

chamber filled with a particular electrolyte solution.

Potassium Electrode Measures potassium by means of a ion-permeable

membrane and a chamber filled with a particular electrolyte
solution.

Chloride Electrode Measures chloride by means of a ion-permeable membrane

and a chamber filled with a particular electrolyte solution.

Reference Electrode Maintains a capillary liquid junction between the reference

Housing electrode and the sample.

Reference Electrode Provides a stable reference potential for measurement of

ISE values.

2.2 Uninteruptible Power Supply/Line Conditioner

An uninterruptible power supply (UPS) is included with the system. The UPS also
incorporates line conditioning to ensure clean and stable power to the system.
The UPS provides a five-minute battery-powered backup power supply to the system if
main power is lost. The system software finishes any tests that can be completed within
this five minute interval and reschedules any that cannot. The rescheduled tests will be
rerun once main power is restored. If power is restored before five minutes has elapsed,
the system continues with the workload as if power was not interrupted.

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2.3 Consumables
Various consumables and reagents are required for day-to-day operation. These
products can be obtained from your Alfa Wassermann Diagnostic Technologies, LLC
representative.

2.3.1 Cuvettes

Disposable cuvettes are provided in cartridges of twenty cuvettes for easy loading into
the system (Figure 6). The cuvettes have an optical pathlength of 0.67 cm and are
specially constructed from optical quality plastic.
The cuvettes are stored in the cuvette hopper, which holds up to 200 individual cuvettes.
During operation, cuvettes are transferred from the cuvette hopper to the reaction wheel,
where the reagents and sample are added to the cuvette and the ensuing reaction is
measured. As each test is completed, the used cuvette is ejected into the cuvette waste
box and a new cuvette is loaded onto the reaction wheel from the cuvette hopper.

Figure 6. Cuvette Cartridges

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2.3.2 Seglets

Disposable seglets (Figure 7) are used for automatic dilution of samples and for holding
aliquots of samples that are aspirated from primary tubes. Each seglet contains ten
sample wells. Three clean seglets are loaded onto a well segment (see Figure 8) by the
operator when preparing for a run.
The well segment is positioned on the posts along the outside edge of the
sample/reagent tray. At least one complete well segment containing three clean seglets
should be loaded onto the system when preparing for a run.

Figure 7. Seglet

Figure 8. Well Segment

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2.3.3 Sample Cups

Sample cups contain samples that are individually loaded onto the system. The sample
cups are filled by pouring or pipetting an aliquot of the sample into the cup.
A cup segment (Figure 9), contains up to 15 sample cups on the system. When
preparing for a run, the operator fills a sample cup and places the cup into one of the
numbered positions on the cup segment following the loadlist. After the cup segment has
been filled with the cups for the run, the operator places the cup segment on the posts
along the outside edge of the sample/reagent tray.

Sample Sample Cup

Cup Position

Figure 9. Cup Segment

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2.4 Reagents, Calibrators and Controls

Reagents, calibrators and controls are required for routine operation. A large selection of
these products can be obtained from your Alfa Wassermann Diagnostic Technologies,
LLC distributor.

2.4.1 Chemistry Reagents

Chemistry reagents are provided in large (30 mL) or small (12 mL) bottles that fit on the
system reagent tray. A computer-coded label (Figure 10) on the bottom of each bottle
provides automatic identification of the reagent, the lot number and sequence number.

? Note: Contact your Alfa Wassermann Diagnostic Technologies, LLC distributor

for a list of available reagents.

Figure 10. Computer-Coded Chemistry Reagent Label

2.4.2 Chemistry Calibrators

The system must be calibrated before results for any test (except zero order kinetic
tests) can be obtained. Calibration is performed using calibrator(s) that contain a known
concentration of analyte(s) to be calibrated. The values that are obtained when running
calibrators are used by the system to calculate the results when patient samples are run.
Calibration must be repeated whenever a new lot of reagent is used and/or at intervals
that are defined for a particular test.
The number of calibration points (and therefore the number of calibrators) that are
required for a test depends upon the particular test. In some cases, a single calibrator is
needed. In other cases, up to six calibrators are used. Required calibrators are listed
automatically when test calibration is requested. Refer to page 120 for additional
information.

2.4.3 Controls

Controls are serum-based products that contain a known level of the analytes that are
being measured. Controls in several levels (normal, abnormal) of each analyte are
available. At least two levels of controls should be tested each day the instrument is run
to verify acceptable performance of the system.
Refer to pages 117 and 140 for additional information on the use of controls.

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2.4.4 ISE Reagents and Calibrators

Separate reagents and calibrators are required for the ISE system:
?? Reference Electrode Solution. A concentrated solution of potassium
chloride that is used to provide a stable liquid junction potential for the ISE
reference electrode.
?? ISE Wash Solution. A solution used to flush the ISE sample port in order to
remove traces of protein or cleaning solutions.
?? ISE CAL-A. One of the two-level solutions used for calibration of sodium,
potassium and chloride measurements and single point calibrations. ISE
CAL A is stored in the system fluids compartment (Figure 29).
?? ISE CAL-B. One of the two-level solutions used for calibration of sodium,
potassium and chloride measurements.
?? Cleaning Solution. A solution used for periodic cleaning of the ISE
electrodes.
?? Conditioner. A solution used for periodic conditioning of the ISE
electrodes..

2.4.5 System Diluent

System diluent is used for rinsing the probe between reagent and sample transfers and
for diluting samples or a reaction mixture. System diluent is stored in the system fluids
compartment (see Figure 29).

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2.5 Integrated Computer Workstation

The PC-compatible computer workstation provides the user interface for the system.
This computer workstation is integrated within the instrument in order to minimize space
requirements.

2.5.1 Computer

The computer directs all system functions. It controls operation of the analysis module, it
provides an external disk drive (drive A) for loading programs and transferring
information, and it controls the user interface to the system.

2.5.2 Keyboard

The system is supplied with a 83-key standard keyboard.

Certain system functions are accessed by means of the function keys on the keyboard.
Many of the function keys have a single function identified on the template above the
keys. Other keys have a variable function which is identified on the screen display as
needed.
Use of the function keys and other special keys is summarized below:

Key Function Purpose

F1 Help Displays current on-line help text.

F2 Choice List Displays selections available for a particular field. Note: the
prompt (F2) is displayed on the message line if selections are
available.

F3 Status Displays the Status menu.

F4 Clear Field Removes all characters in an entry field.

F5 Variable Screen text dependent, definition will be displayed.

F6 Variable Screen text dependent, definition will be displayed.

F7 Variable Screen text dependent, commonly used when placing

samples in the instrument.

F8 Variable Screen text dependent, commonly used for printing.

F9 Attention Displays the Attention message(s).

Note: When operator intervention or acknowledgement is

required an ATTENTION indicator is illuminated.

F10 Accept Accepts a screen, saves screen changes or acknowledges

that a task is complete.

Fn F2 Instrument Displays the Instrument Access menu.

Access

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Key Function Purpose

Enter Enter Acknowledges a selection or action.

Insert Insert Inserts a new item.

Delete Delete Deletes an existing item.

Home Home Returns the cursor to the first entry field of a screen.

Esc Escape Returns the display to a prior screen or menu level until the
Main menu is displayed.

Ctrl Control Performs special features when used simultaneously with

different function keys.

Fn Function Enables the alternate functions that are printed on each key.

Ctrl F6 RTI Simultaneously pressing both keys enables or disables the

rapid tube input mode used when placing multiple samples in
the STEP.

Ctrl F5 OT Simultaneously pressing both keys overrides the temperature

default timer (started after reinitialization). Tests will not be
processed until the system temperature has equilibrated.

Esc
Key Function
Keys

LED Indicator
Lights

Ctrl Fn Alt
Key Key Key Enter
Key
Arrow
Keys

Figure 11. Function Keys and Other Special Keys on the Keyboard

2.5.3 Printer

The laser printer allows the various system reports to be printed.

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2.5.4 LCD Monitor

The LCD monitor displays all user interface screens, menus, forms and messages. This
allows the operator to access system functions, enter information and view results.
Information displayed on the monitor is organized so that the same screen elements are
displayed in the same location on the screen (Figure 12). Status information such as
analyzer state, software version, date and time, and the system access level are always
displayed at the top of the screen. Menus and the various data entry and information
screens are displayed in the center portion of the screen. Finally, status indicators and
instructions concerning the highlighted command or field are displayed at the bottom of
the screen.

Analyzer State Menus User Access Level Date and Time

Instructions Hopper Status Variable Temperature Status

or Information Indicator Function Key Offerings Indicator

Figure 12. Display of Information on the Monitor

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2.6 Menus
Menus provide the user with a means to perform the system functions.

2.6.1 Selecting a Menu Command

The options on a menu can be selected in two ways:

?? Use the arrow keys on the keyboard to move the cursor to the desired option and
press the Enter key

?? Press the letter in the menu option that is highlighted and capitalized (e.g. the R
in Requisitions).

2.6.2 Navigating Through Menus

Selection of an item from a menu will display another menu in a cascading fashion, an
information screen or a data entry screen.
Press Esc to return to the prior menu. Continue to press Esc to return to the Main menu.

? Note: Menus may also be displayed when certain function keys are pressed.
Functions keys are discussed in Section 2.5.2.

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2.6.3 Main Menu

The Main menu is displayed on startup. The Main menu is used to access menus for or
otherwise initiate all other system functions:

Command Purpose
Requisitions Create a patient, quality control, calibration, or correction test
request.

Reports Create various system reports.

Cup/Segment Set up a group of up to 15 samples in a cup segment prior to placing

Placement the segment on the system.

Journals View the permanent records of certain system events.

Delete/Archive Delete and/or archive patient data. Reset test counters.

Utilities Displays a submenu of system utilities.

Diagnostics Test system functions and troubleshoot system.

Setup Configure system hardware and customize system software.

Exit to DOS Exits ACE Alera System software and displays the DOS prompt.

User Access Log on or off the system.

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2.6.4 Requisitions

The Requisitions menu is used to create requisitions for patient, QC, calibration, and
correction samples.
Command Purpose
Patient Perform operations related to patient requisitions.

Quality Control Select a control and create a requisition.

Calibration Create a calibration requisition.

Correction Correct a calibration curve.

? Note: A sample cannot be loaded unless a requisition exists in the system for
that sample.

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2.6.5 Reports

The Reports menu is used to view and/or print system reports.

Command Purpose
Patient A single requisition or all completed requisitions for a
patient.

Quality control The last control run or statistical QC reports and plots.

Backlog All incomplete tests.

Calibration Last calibration run or curve correction for a specified test.

Raw data Optical data for a single test.

Test parameters All parameters for a specified test.

Test counts The number of results obtained for each on-line photometric
test in the database since the date the counter was reset to
zero.

Performance Reprints the report of the most recent performance

diagnostic that was run.

? Note: The system is generally configured to automatically print reports for

patient, quality control and calibration requisitions when the requisition is
completed.

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2.6.6 Cup/Segment Placement

The Cup/Segment Placement option on the Main menu displays the Cup/Segment
Placement screen. This screen allows the operator to set up a group of up to 15 samples
in a cup segment prior to placing the segment on the system. The Cup/Segment
Placement screen will display a list of the current segments. If there are no segments
currently saved on the system, the list is blank.

2.6.7 Journals

The Journals menu allows the user to view the permanent records of various system
events.
Command Purpose
Audit Routine events such as the editing of test parameters and
the editing or deletion of results.

Maintenance Maintenance procedures that have been performed on the

instrument and the name of the operator performing the
maintenance.

Error Chronological listing of all system errors.

Service Service procedures that have been performed on the

instrument and the name of the field engineer performing
the service.

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2.6.8 Delete/Archive

The Delete/Archive menu is used to remove a patient from the system and reset the test
counter.
Command Purpose
Delete/Archive Patients Removes and/or archives patients who have had no activity
since a specified date from the database.

Delete Test Counts Resets the test counter for on-line photometric tests to zero.

2.6.9 Utilities

The Utilities menu is used to perform miscellaneous operations.

Command Purpose
ISE Requests calibration or maintenance of the ISE module.

Backup Copies all system data files onto a 3.5 inch disk.

Probe Moves the probe to alignment and test positions.

Temperature Provides an external check on cuvette temperature.

Date/time Sets the date and time.

Software Displays the software version number.

Restore Restores system data or the archive log from a backup

3.5 inch disk.

Language Selects system language.

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2.6.10 Diagnostics

The user interface includes diagnostics to test instrument performance and function.
Command Purpose
Performance Evaluate the performance of the analyzer, loader,
chemistries, ISE and spectral response.

Hardware calibration Adjust certain optical parameters. Other calibrations usually

performed by an Alfa Wassermann Diagnostic
Technologies, LLC Field Service representative.

Troubleshoot Provides access to a collection of functions designed to aid

in testing or troubleshooting the instrument.

Verify modules Checks operation of individual instrument modules. Usually

performed under the guidance of Technical Support.

Initialize instrument Recover from some instrument errors.

Miscellaneous Perform functions related to maintaining the instrument or

preparing it for long term shutdown.

? Caution: Commands on the Diagnostics menu should not be used unless

specified in this manual or by an Alfa Wassermann Diagnostic Technologies,
LLC representative.
Activation of any of the diagnostics commands suspends all normal test
processing.

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2.6.11 Setup

The Setup menu allows the user to customize certain aspects of the system hardware
and software in a manner that best suits the individual laboratory.
Command Purpose
Tests Modify certain specified test parameters such as test
identification and reference range checks.

Calibrators Enter lot specific values for calibrators.

Quality control Enter mean and standard deviation values for control
constituents.

Bottles Define bottles, their type, and their lifetime.

Panels Define a group of tests that are ordered together as a panel.

Doctors Add a doctor to the system.

Carryover Define a special rinse to be performed before pipetting a

specific reagent.

Miscellaneous Define certain system parameters such as facility ID,

reporting options, archiving mode and date format.

Performance Diagnostic tools for use by Field Service personnel.

Hardware Enable the ISE module and a LIMS, turn off the reagent
cooling system, set the sound level of the beeper.

Label Symbology Configure barcode label parameters for systems with

optional barcode scanner.

? Note: Access to the Setup menu may be restricted to authorized individuals if

the multilevel password function is enabled.
The Label Symbology command is displayed only if the system is equipped
with an optional barcode reader.

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2.6.12 Status Menu

The Status menu allows the user to check the status of critical areas of the system. The
Status menu is displayed by pressing the F3 key on the keyboard.

The following table provides a brief description of the commands available from the
Status menu:
Command Purpose
Reagent tray For each reagent bottle on the tray, displays remaining
volume, lot number, onboard lifetime, position and whether
or not it is required for pending requisitions on active
samples.

Calibration Calibration status of reagents.

On-hold Items that need to be cleared.

Sample ring Segments on the sample ring and their contents.

Hopper Number of cuvettes remaining.

Database Database capacity of the system for bottles, controls,

panels, patients, requisitions and tests. Displays the number
remaining, number used, and maximum allowed.

? Note: The status of these areas should be checked prior to daily routine
operation of the system. Expired reagent bottles must be removed from the
reagent tray.

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2.6.13 Access Menu

Opening or accessing certain compartments while the instrument is in operation can

interfere with processing. Therefore, access to these compartments is controlled by
means of the Access menu. This menu is displayed by pressing the Fn and F2 keys on
the keyboard. The desired compartment is selected from the menu and the instrument
displays a series of messages guiding the operator through the access steps.

? Note: The segment door will remain locked until Fn and F2 are pressed for
access.

The following table provides a brief description of the commands available from the
Access menu:
Command Purpose
Segment Place or remove cup or well segments.

Reagents Place or remove reagent bottles.

Hopper Load cuvettes into the hopper.

Containers Replace system fluids or access the ISE module.

Cup Remove a sample cup, refill a sample cup with a fresh

aliquot, or change an expired sample cup with a freshly filled
one.

Once access is complete, pressing ESC closes the Access menu and allows operation
to continue.

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2.7 System Information

The user interface screen displays various types of information regarding system
operations (refer to Figure 12).

2.7.1 Analyzer State

The analyzer state represents its operational condition. There are six states:
Analyzer State Condition
STANDBY Waiting to perform tests.

IDLE Waiting for a command.

BUSY Performing tests.

INITIALIZING Resetting system.

DIAGNOSTICS In the diagnostic testing mode.

ERROR A system error has occurred.

2.7.2 Software Version

The software version represents the version of the operating software that is running on
the system.

2.7.3 User Access

The ACE Alera System can be configured with a multi-level password system to limit
user access to menu options. One of four levels of access (NONE, LEVEL 1, LEVEL 2,
LEVEL 3) can be defined for each menu option with the exception of Requisitions.
Each level of access (with the exception of NONE) requires the entry of a unique
password in order to use the menu options. The current user access level is displayed
on the upper right of the user interface.
The user logs on the system via the user Access selection on the Main menu. The user
Access menu has log in and log out options.
At log in, a password is entered. The user can then access all menus with that level
assignment. If the user attempts to access a menu with a higher access level, the
system displays a password prompt.

? Note: Contact your Alfa Wassermann Diagnostic Technologies, LLC technical

service representative for instructions to define user access levels and their
corresponding passwords.

The log out selection signs the user off the system and returns the user access level to
NONE.

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2.8 Specifications
ACE Alera System specifications are summarized below.
ANALYZER
General
Start-up time 15 minutes from power-up
Analysis Types Spectrophotometric, Potentiometric (optional)
Assay Types Final Point, Delta (two-point)
Slope (factor or calibrated)
Quadratic
Throughput Up to 165 results/hour
STAT Turnaround Between 1 and 15 minutes depending on test(s) ordered
Time
Calibration Frequency
Optical Monthly sample delay and optical calibration.
Photometric Test dependent (refer to package insert)
Potentiometric Automatic every three hours
Analytical 37 ?C ± 0.3 ?C
Temperature
Ambient Room 15 ?C (59 ?F) to 32 ?C (89.6 ?F)
Temperature
Humidity 20 to 80% RH (non-condensing)
Maximum Cuvette 248
Capacity
Power Rating
Analyzer 100-240 VAC, 47/63 HZ, 6 Amps Max.
ACE Alera 450 Watts Max (Analyzer only)
Nominal
Printer 120 or 240 VAC, 66 Watts Idle
340 Watts Operating
700 Watts Peak
Sample Delivery
Presentation to Closed or open tube
System Sample cups individually
Sample cups in groups of up to 15 on cup segment
Segment Capacity Five in combination (cup and/or well)
Tube Size for Direct 75 to 100 mm length; 13 to 16 mm diameter
Sampling
Stopper Styles Rubber stopper, VACUTAINER with Hemogard Closure or
stopperless.

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Fill Volume Required Between 0.9 inches and 2.23 inches from top of glass tube
for Tube sampling
Serum Volume Minimum 0.5 inches above clot or separator
Required for Tube
Sampling
Sample Capacity 75-150 samples
15 sample cups/cup segment
30 samples wells/well segment
Sample ID Positive ID by optional barcode or requisition match for closed
or open tubes
Loadlist or requisition match for sample cups
Barcode Type Uniform Symbology Specification 39, Code 128 Set B and Set
C, Codabar and Interleaved 2 of 5
Barcode Placement Within the range of 0.09 inches and 2.35 inches from top of
Zone glass tubes with a maximum of 5? skew (slant)
Sample Delivery 3-200 ? L in 1 ? L increments
Capacity
Typical Volumes Used 3-20 ? L
Sample Dead Volume 90 ? L per seglet
Sample Delivery Less than 5% CV at 3 ? L
Precision
Level Detection Automatic with liquid level sensor
Sample Integrity 2 or 4 hours onboard working lifetime clock (2 or 4 can be
selected on the setup analyzer screen)
Reagent Delivery
Reagent Compartment 40 bottles
Capacity 20 with 30 mL capacity
20 with 12 mL capacity
Reagent Compartment 8 ?C + 1 ?C at the reagent sensor
Temperature
Reagent ID Positive ID by computer coded labels on bottom of bottles
Reagent Delivery 3-500 ? L in 1 ? L increments
Capacity
Reagent Delivery Less than 0.5% CV
Precision
Level Detection Automatic with liquid level sensor
Reagent Integrity Onboard working lifetime clock

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Optical System
Absorbance
Measurement
Type Holographic diffraction grating
Linear Range 0.0000–2.0000 O.D. at 0.67 cm pathlength
Wavelengths 340, 378, 408, 447, 486, 505, 515, 525, 544, 554, 573, 592,
610, 629, 647, 692 nm
Lamp Pulsed Xenon
Pathlength 0.67 cm
Cuvette Volume 150-600 ? L
Analysis Cycle 10 seconds
Potentiometric System
Sample Type serum
Assay Volume 156 ? L (a minimum of 206 ? L required in cup to accommodate
probe depth and dead volume)
Analytes Measured Sodium
Potassium
Chloride
Analysis Cycle 90 seconds
Computer Processor IBM-compatible PC®
RAM Memory 32 MB
Graphics Adaptor Color SVGA compatible
External Disk Drive 3.5 in., 1.44 MB
Hard Disk Drive 20 GB
Operating System MS-DOS 6.22
Keyboard Type 83 key
LCD Monitor
Type 12.1 in. TFT Active matrix panel
Resolution SVGA 800 pixels by 600 pixels
Printer
Type Okidata B4200 Laser
Speed 19 pages per minute maximum
Resolution 600 by 1,200 dots per inch
Interface Centronics parallel compatible
Paper Type Standard letter
Capacity 250 sheets

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Database Capacities
Analyzer Procedures
(Performance) 15
Bottles 250
Controls 20
Doctors 200
Dyes 15
Loader Procedures
(Performance) 2
Panels 16
Patients 1000
Requisitions 5000
Requisitions per 200
Patient
Tests 200

? Note: Specifications are subject to change without notice.

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3 Principles of Operation

The ACE Alera System initiates a chemistry measurement by transferring measured

amounts of sample and reagent into a cuvette. The cuvette contents are mixed,
incubated, and then optically analyzed at the times and wavelengths specified in the
programmed parameters for that test. The data obtained from the optical analysis
measurements are then converted to reportable units using calculations that are
specified in the programmed parameters for that test.
The optional ISE module determines the activity of sodium, potassium and chloride in a
sample by means of ion-selective electrodes. Each electrode contains an electrolyte
solution and a membrane that is specific for the ion that is to be measured. When the
sample is introduced, the specific ion is transported into the membrane and a difference
in electrical potential develops between the solution inside the electrode and the sample.
This difference in potential is measured by the electrode and the system determines the
ion concentration in the sample.

3.1 Operational Sequence Overview

3.1.1 Task Scheduling

The system contains software that schedules the order in which the instrument performs
pending tasks. Each sample that is presented to the system for testing is associated with
a requisition that delineates the tests to be performed and whether the test is routine or
STAT. A STAT test will always be scheduled ahead of a routine test.
The software will schedule any calibration activities that are necessary and then samples
and controls are run on a first-in-first-out (FIFO) basis according to time of introduction to
the system.

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3.1.2 Priority of Instrument Activities

Instrument activities are performed with the following priority:

Priority Activity
First Perform loading operations that follow an incubation period.

Second Introduce a sample from the STEP.

Third Complete a partially completed cuvette loading sequence.

Fourth Begin the loading sequence for a test, calibration or

correction.

Lowest Perform background tasks in the idle or standby mode.

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3.1.3 Analysis Sequence

The sequence of events that occur during analysis is summarized below:

Event Purpose
Requisition Entry/ Create requisitions, order tests and load samples.
Sample Loading

Fluid Transfer Pipette samples, diluent, buffers and reagents into cuvettes.

Probe Washing Clean probe between sample aliquots and dilutions.

Incubation Incubate reaction mixture as required in the individual test

parameters.

Blank Readings Read an internal and/or external blank as required in the

individual test parameters.

Data Acquisition Obtain optical data and process at the wavelengths

specified in the individual test parameters.

Integrity Checks Check validity of test data.

Result Reporting View, print or transmit test results.

3.1.4 Monitoring System Resources

The software monitors the status of the system during testing and alerts the operator to
conditions that may affect system performance.
The system checks that the required reagents, diluents and calibrators are available
whenever a test is requested. If one of the necessary components is missing, a warning
is displayed and the test is placed on hold.
The liquid level, lot number and working lifetime of each reagent are also verified. If a
new lot number of reagent is detected, a calibration is required before that reagent can
be used. If the working lifetime of a reagent has passed, the system displays a warning
and sets the bottle status to “expired,”which requires the bottle to be replaced.

The system also monitors samples, calibrators and controls for volume and the length of
time they have been in the instrument. Appropriate warnings of short volume or
exceeding time limits are displayed.

3.1.5 Calibration of Photometric Tests

All chemistry tests except zero-order kinetic tests require a stored calibration curve. A
calibration curve is constructed by measuring and storing responses to known
concentrations of a calibrator. Sample results are calculated by interpolation and curve
fitting techniques that are based on the stored calibration curve.

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A calibration run will utilize from one to six calibrators, specified in the program test
parameters. A stored calibration will remain in memory until either a new calibration is
requested or the test parameters have been modified. When a new calibration is
accepted it will replace the previously stored curve. The date and time of the calibration
will be recorded and a calibration report will automatically be printed if enabled in setup.
If a calibration fails, no new sample requests for that particular analyte will be processed
until a valid calibration is stored. Any samples already in process will be aborted.

3.1.6 Calibration of Potentiometric (ISE) Tests

The ISE system automatically performs a two-point calibration if no calibration curve is

stored in the system (e.g. after a cleaning and conditioning cycle) or if it has been more
than three hours since the last calibration was performed. The operator also has the
option of requesting a calibration. The frequency of automatic calibration is dependent
upon the calibration mode that was selected during configuration of the system. Two
modes are available:
?? STANDBY – calibration is only performed when a sample is introduced for ISE
testing and it has been greater than three hours since the last calibration.
?? STAT READY – calibration is performed every three hours.

The three ISE channels (sodium, potassium, chloride) are calibrated together and all
three must pass in order for the calibration curves to be stored. If a channel fails, the
calibration will be repeated. Any channel that cannot be calibrated after three attempts is
marked as having failed calibration and an attention message is displayed.

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3.1.7 Curve Correction

When a full calibration is performed for a test, a curve corrector (correction) can be
analyzed at the same time. A curve corrector may contain the analyte, and is not
necessarily a calibrator. For example, distilled water may be used as a corrector. The
response of the corrector is stored with the curve. The corrector material can be
requested any time after that.
The change in the response of the corrector between the original value stored and the
current value obtained is used to adjust the curve. The curve may be adjusted by
changing the slope or the offset. If the curve is non-linear, the corrector response and
result must be between the lowest and highest calibrator.
If a slope correction is used, each of the stored calibrator responses is adjusted by the
ratio of the stored response of the corrector to its correction response. The result is a
change in the shape and orientation of the calibration curve. The following calculation is
used:

New Cal Resp. = Cal Resp. x (Correction Resp. of Corrector/Stored Resp. of Corrector)
An offset correction adjusts each of the stored calibrator responses by the difference
between the stored response of the corrector and its correction response. This implies
that the correction has the same effect on each of the calibrators. For tests that use only
one calibrator, offset correction is not permitted. The following calculation is used:

New Cal Resp. = Cal Resp. + (Correction Resp. of Corrector – Stored Resp. of Corrector)
Should an error occur during a correction run, the correction values are not stored. The
calibration or correction must be repeated.

3.1.8 Calibrator Averaging

More than one response may be averaged for each calibrator and corrector when
calculating a curve. Up to four replicates for each response are allowed. Each calibrator
is loaded into the specified number of cuvettes. If an external blank is required, only one
is loaded per calibration. The mean response for the calibrator is calculated from the
response for each of its cuvettes. The averaged value is used to calculate or correct the
curve.

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3.1.9 Response Calculation

The response for a test is calculated from the optical data obtained for the readings
specified in the test parameters. The data are assembled into algebraic equations that
define the response. The basic types of equations are described below:
Equation Description
Final Point Based on the final data point.

Delta Based on the difference between the final and initial data
points.

Slope Based on a linear regression slope through all the valid data
points taken. Needs a minimum of four points.

Quadratic Delta Based on a quadratic least squares fit of the data.

3.1.10 Result Calculation

The final result for a sample represents either the concentration or activity of the analyte.
Calculation of the result is based on the use of calibrators or a predefined factor. The
different types of calculations can be used in combination with any of the response
calculations. Four calculation types are available in the ACE Alera System.
Type Description
Factor The response is multiplied by a predefined factor that is
stored in the test parameters.

Linear The response and the result have a linear relationship. A

linear regression is performed on the calibrator data to
obtain the slope and y-intercept for the calibration curve.

Non-Linear Interpolation The response and result have a non-linear relationship.

Three to six calibrators can be used to determine the
interpolation data.

Four Parameter The response and result have a non-linear relationship. Four
Non-Linear Least to six calibrators can be used to determine the convergence
Squares Fit of the curve.

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3.1.11 Routine Chemistry Equations

The calculation equations used for routine chemistry tests performed on the ACE Alera
System are described below. The symbols used in the equations are defined following
the equations.

Final Point with Calibration or Factor and an Internal Reagent Blank Correction
V(P)
Result = {(AUW1 – AUW2) - ?(AUIRBW1 – AUIRBW2) x ?} x Cal Factor or Factor
V(T)

? Note: The internal reagent blank corrects for a change in the reagent
absorbance.

Final Point with Calibration or Factor and an External Sample Blank and an
Internal Reagent Blank Correction
V(P)
Result = {(AUW1 – AUW2) - ?(AUIRBW1 – AUIRBW2) x - (AESBW1 – AESBW2)? x Cal Factor or Factor
V(T)

? Note: The internal reagent blank corrects for a change in the reagent
absorbance. The external sample blank corrects for the contribution of the
sample absorbance to the final reaction absorbance.

Final Point with Calibration or Factor and an External Reagent Blank and Internal
Sample Blank Correction
V(P)
Result = {(AUW1 – AUW2) - ?(AUISBW1 – AUISBW2) x - (AUERBW1 – AUERBW2)? x Cal Factor or Factor
V(T)

? Note: The external reagent blank corrects for a change in the reagent
absorbance. The internal sample blank corrects for the contribution of the
sample absorbance to the final reaction absorbance.

Slope with Calibration or Factor and an External Reagent Blank Correction

Result = ?(?A/minUW1 - ?A/minUW2) – (?A/minERBW1 - ?A/minERBW2)? x Cal Factor or Factor

? Note: The external reagent blank corrects for the drift of the reagent. It is taken
whenever a new bottle of reagent is used and when a re-calibration of the
system is performed.

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Delta – Two Point with Calibration or Factor and an External Reagent Blank
Correction

Result = {?(AUT2W1 – A UT2W2) – (AUT1W1 – AUT1W2)? - ?(AERBT2W1 – AERBT2W2) – (AERBT1W1 – A ERBT1W2)?} x

Cal Factor or Factor

Symbol Definition
A Absorbance reading.

?A/min The change in absorbance per minute based on linear

regression slope analysis.

Cal Factor A constant that is obtained during calibration and is equal to

the concentration of the calibrator divided by the average
response of the calibrator.

ERB External reagent blank.

ESB External sample blank.

Factor A constant that is determined independently and

programmed into the parameter table.

IRB Internal reagent blank.

ISB Internal sample blank.

T1 Time of initial reading.

T2 Time of second or final reading.

U Unknown.

V(P)/V(T) Correction for the difference in volume at the time of a

partial load and the volume at the time of a total load.

W1 Reaction wavelength.

W2 Bichromatic correction wavelength.

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3.1.12 Running Tests

A requisition must be created for each sample that is introduced for testing. This
requisition identifies the type of sample (patient, quality control, calibrator) and the tests
to be performed on the sample. Photometric and potentiometric tests may be ordered on
the same requisition. Each requisition is assigned a unique Accession number that is
used to track it through the system. Accession numbers may be manually assigned, or
the system may be configured to automatically assign an Accession number when a
requisition is created. Samples are then loaded into the system as a batch or individually
in preparation for testing.

? Note: The Patient First Name (if required), Patient Last Name, Patient ID,
Accession number, and at least one test to be run are required for a patient
requisition.

For photometric tests, the system automatically dispenses the appropriate reagents into
a cuvette in the reaction wheel, aspirates the required sample volume and dispenses it
into the cuvette. The system then performs any incubations that may be required as
determined by the parameters that have been preprogrammed for the test.
When the reaction is complete, each cuvette is passed through the system and it is read
at the appropriate wavelength or wavelengths for the test. The data is processed and
results are calculated.
For potentiometric (ISE) tests, the probe draws up several aliquots of the sample and
dispenses them through the electrode block to “prime”the tubing and the electrodes.
The electrode block is emptied and air bubbles are introduced into the line to aid in the
removal of the previous sample. The sample is then pumped into the measuring
chamber of the electrodes and the electrical potentials are measured several times.
The system performs checks against pre-programmed limits to detect possible ADC
saturation. The chambers are then filled with CAL-A and the electrical potentials are
again measured. At the completion of the measurement cycle all measurements are sent
to the workstation and the sample results are calculated based on the voltage difference
between the sample and the CAL-A and the stored calibration curve.

3.1.13 Integrity Checks

The ACE Alera System automatically verifies the validity of test results using limits that
are included in the test parameters. When an error is detected, a flag is reported instead
of a test result. This gives the operator the opportunity to evaluate the nature of the
error and take appropriate corrective action. Under certain circumstances, the system
will require that the operator perform a manual verification of a test result.
The system will automatically dilute and rerun a test on a patient sample if the results
have exceeded the linearity or calibration limit of the test or if substrate depletion has
occurred. Only one automatic rerun is permitted for a test. The system will not perform
automatic reruns on controls, calibrators, correctors or potentiometric (ISE) tests.

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The chemistry flags that may be displayed or reported depend upon the type of data
being verified:

Optical Data Flags

Flag Description
ANALZ Problem detected on the upper or lower photodetector output
(automatic) limits, the upper or lower limits on the averaged transmission or
intensity values or on the comparison of data to system offsets.
ANALZ Absorbance for a cuvette exceeds the maximum allowable value.
(automatic)
NEGABS Absorbance for a cuvette is less than the minimum limit (-0.05).
(automatic)
MXINIT Optical data for the early data point exceeds the maximum limit
(configurable) defined in the test parameters.
MNINIT Optical data for the early data point is less than the minimum limit
(configurable) defined in the test parameters.
DEPL Substrate depletion. Error occurs when ? A between the early data
(configurable) point and any of the first 4 readings in the reaction exceeds the
limit set in the test parameters.
MXRBDP Optical data point for the internal reagent blank exceeds the
(configurable) maximum limit.
MNRBDP Optical data point for the internal reagent blank is less than the
(configurable) minimum limit.

Response Flags

Flag Description
SIGN Reaction direction is incorrect based on the test parameters.
(configurable)
SE Standard error of linear regression in slope response calculation
(configurable) (> max. limit).
LT LC, GT HC Response is either less than the lowest or greater than the highest
(automatic) calibrator. Check is performed if Four Parameter Non-Linear Least
Squares Fit or Non-Linear Interpolation is used in results
calculation.
MAXERB Response for the external reagent blank exceeds a maximum
(configurable) limit.
MINERB Response for the external reagent blank falls below a minimum
(configurable) limit.
RSS The root-sum-square of the residuals for a quadratic least squares
(configurable) fit exceeded the maximum limit.

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Result Flags

Flag Description
LIN Reported when a sample result exceeds the linearity limit for the
(configurable) method. If the sample has been automatically rerun with a dilution,
the linearity limit is scaled by the rerun dilution factor before the
check is made.
LT LC, GT HC A sample result is either less than the lowest or greater than the
(automatic) highest calibrator. Check is performed if Four Parameter Non-
Linear Least Squares Fit or Non-Linear Interpolation is used in
results calculation. If the sample has been automatically rerun with
a dilution, the range endpoints are scaled by the rerun dilution
factor before the check is made.
LT 0 Result is less than zero (negative result).
(automatic)
FORMAT Result exceeds the allowable format field size.
(automatic)
LTLL, GTHL An ISE result is either less than the lowest limit or greater than the
highest limit of electrode measurement.

Calibrator Flags

Flag Description
MATH Calibrator response is zero. A ratio cannot be determined (division
(automatic) by zero is not permitted).
CALFAC Ratio of the concentration of a calibrator or a corrector to its
(configurable) average response exceeds the range defined in the test
parameters. A non-calibrator corrector is compared to the
allowable range of the nearest calibrator.
CALDEV The expected result for a calibrator deviates from the calculated
(configurable) result obtained from the least squares fit calibration curve more
than the maximum limit set. This check is performed on Four
Parameter Non-Linear Least Squares Fit calibration curves or
Linear calibration curves.
CORDEV The correction response for a corrector deviates from its stored
(configurable) response by more that the maximum limit set.
NONMON A calibration curve is not sequentially increasing or decreasing.
(automatic)
CONVRG Improper curve fit using Four Parameter Non-Linear Least
(automatic) Squares Fit calculation.
CAL SN Correction changed the sign of a calibrator response in a
(automatic) correction run.

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Result Verification Flags

Flag Description
H Patient result exceeds upper range of normal limit configured in
(configurable) the test parameters.
L Patient result falls below lower range of normal limit configured in
(configurable) the test parameters.
HH Panic result. Patient value exceeds upper panic limit programmed
(configurable) in test parameters.
LL Panic result. Patient value is less than lower panic limit
(configurable) programmed in test parameters.
D Result was obtained on a diluted sample.

? Note: A panic flag (HH or LL) may be reported under the following conditions
even though another error has been detected in a run:
?? HH is reported when the patient result also exceeds the linearity limit
(LIN).
?? HH is reported when the patient result is equal to or exceeds the highest
calibrator (GT HC).
?? LL is reported when the patient result is equal to or lower than the lowest
calibrator (LT LC).

3.1.14 Automatic Sample Rerun

A patient sample will automatically be diluted and rerun (provided that a dilution ratio has
been specified for the test) when one of the following occurs:
?? The result exceeds the linearity limit of the test (linear test).
?? The result exceeds the calibration range for the test (non-linear test).
?? Substrate depletion occurs.
The sample is diluted with the diluent specified in the parameters for that test. The result
for the diluted sample is automatically multiplied by the dilution factor and flagged with a
D when reported to indicate the sample has been diluted.
The system will rerun a sample only once for a given test within a requisition. Automatic
reruns are not performed on controls, calibrators or correctors.

3.1.15 Result Correlation

ACE Alera System test results can be correlated to the results from a different
instrument or test method. A correlation study is performed and the slope and y-intercept
from a linear regression equation are entered into the test parameters. The correlated
result is obtained by multiplying the ACE Alera System result by the slope and adding
the value of the y-intercept.

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3.1.16 Reporting Results

A wide variety of patient and quality control reports are available. These may be printed
at the workstation or can be transmitted to an off-line laboratory information
management system (LIMS).
The system can be configured to automatically print a report for patient, quality control
and calibration requisitions, or it can be set up so that a patient report must be reviewed
before it can be printed or transmitted to a LIMS.

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3.2 Operational Precautions

Certain precautions must be followed while using the ACE Alera System and ISE
module to ensure operator safety, proper performance of the instrument, validity of the
test results and to avoid damage to system components.

3.2.1 General Precautions

?? To assure optimum performance, follow the specific instructions in the reagent

package inserts for the proper handling of patient samples, and reagent
preparation and storage. Perform all scheduled system maintenance as
described in the Maintenance section of this manual.
?? All chemistry performance claims are based on the use of ACE Alera System
reagents and cuvettes. Use of products other than those specified may result in
performance outside Alfa Wassermann Diagnostic Technologies, LLC
specifications.
?? The cuvettes used in the ACE Alera System are intended to be discarded after
being used once. They cannot be washed and reused, as loss of optical clarity as
well as contamination can occur resulting in the loss of accuracy in subsequent
test results.
?? Do not refill empty reagent bottles or add fresh reagent to an existing bottle of
reagent. Reusing or refreshing reagent bottles can cause contamination and/or a
reduction in expected reagent stability. An error will be displayed and the system
will not permit the bottles to be used. Always replace empty bottles with new
ones.
?? To maintain constant temperature control within the reagent and analytical
components, the segment and reagent access covers should not be left open.
Open the covers only when placing or removing reagent bottles, segments or
sample cups or when performing prescribed system maintenance.
?? Always turn the power to the system off at the UPS before removing the air filters
for cleaning to avoid potential injury from the cooling fans.
?? Always turn the power to the system off at the UPS and unplug the power cord
from the analyzer before replacing the main power fuse.
?? Always wear appropriate personal protective equipment (lab coat, gloves, eye
protection) when operating or performing maintenance procedures on the
system.

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3.2.2 Additional ISE Module Precautions

?? For optimum performance, samples to be assayed for ISE tests should not be left
on the system for more than four hours.
?? Never turn off the power to the analyzer for an extended period (i.e., more than
four hours) without first going through the ISE Shut Down Procedure. Failure to
follow this procedure can result in damage to the electrodes, reference housing
and tubing. Damage can also occur if the ISE is left without CAL-A for an
extended period.
?? Perform ISE cleaning and conditioning daily. Place the ISE cleaning solution,
sodium electrode conditioner and ISE wash bottles in the reagent compartment
to perform the procedures.
?? Remove any crystals that may develop on the tubing, container caps or
electrodes. Wipe up ISE fluid spills.
?? The CAL-A, CAL-B, and reference solution containers and the ISE wash bottle
should never be refilled. Always replace them when necessary.
?? All tubing should be secured within the tubing holders and not allowed to hang
loose.
?? Always handle electrodes with care. The reference electrode must always be
stored in the transport housing filled with reference solution and never
allowed to become dry or come in contact with other fluids including water.
The reference housing should be cleaned and dried before storing. Water should
never be used to rinse the reference electrode.
?? Do not insert the stylet into any of the electrodes.
?? Whenever an electrode is removed and replaced, a two-point calibration must be
run before assaying for ISE tests.
?? Analyze serum samples within one hour of collection to minimize changes in
concentration. When serum remains in contact with red blood cells, potassium
shifts occur, resulting in an increase of potassium measured. If samples cannot
be measured within four hours, remove fluid from cells and store in a capped
tube or sample cup in the refrigerator. Prior to measuring refrigerated samples,
allow them to warm to room temperature.
?? Do not use control sera prepared with ethylene glycol or ammonium carbonate
diluents as they will give erroneous results.
?? Reference housings should be cleaned weekly in bleach, to prevent clogging of
the capillary tube with protein.
?? Make certain salt crystals or liquids do not come in contact with the CAL-B
aspirator or the CAL-B solution, as CAL-B will become contaminated, resulting in
a low potassium calibration slope and elevated potassium results.

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4 System Setup
Unpacking and installation of the ACE Alera System is to be performed only by an
authorized Alfa Wassermann Diagnostic Technologies, LLC representative.
This section provides information on selecting and preparing the site for installation and
information about connecting the various components.

Caution: Do not attempt to unpack or install the system unless an

authorized Alfa Wassermann Diagnostic Technologies, LLC representative
is present. Any damage that results may invalidate the warranty.

4.1 Materials

? Note: Contact your Alfa Wassermann Diagnostic Technologies, LLC

representative for additional information (such as Part Numbers) concerning
the material listed below.

4.1.1 Materials Provided

Article Quantity
Analyzer 1
Operator’s Manual 1
AC Power Cords (Analyzer, Printer) 2
Printer 1
Printer Cable 1
Uninterruptible Power Supply (UPS)/ 1
AC Line Conditioner
UPS Interface Cable 1
Sample/Reagent Tray 1
Waste Bottle 1
System Diluent 1
Waste Bottle Cap Assembly 1
System Diluent Bottle Cap Assembly 1
Set of Installation Disks 1
Air Filters 2
Cup Segments 5
Well Segments 3
Sample Cups 1 bag
Cuvettes 1 box

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Article Quantity
Seglets 1 bag
Evap Caps 1 box
Cuvette Waste Box 1
BIOBAGS 1 box
Maintenance Kit 1
Maintenance Log 1
Master Log 1

4.1.2 ISE Parts

Article Quantity
Tubing Set, Pump 1
Air Inlet Tubing (3.5 in., Light Blue Banded) 1
Cap, CAL-B Bottle Assembly 1
Waste Transport Tubing (8.5 in., Green Banded) 1
CAL-A Transport Tubing (10.0 in., Red Banded) 1
Sample Transport Tubing (8.5 in., Green Banded) 1
Measuring Chamber Waste Tubing Assembly (13.0 in., 1
Black Banded)
Measuring Chamber Inlet Tubing (2.5 in., Purple Banded) 1
Reference Housing Outlet Tubing Assembly (12.0 in., 1
Yellow Banded)
Cap, Reference Bottle Assembly 1
Reference Housing Inlet Tubing (10.75 in., Dark Blue 1
Banded)
Cal A bottle cap assembly 1
ISE Service Syringe 1

4.1.3 Materials Provided at Installation

Article Quantity
GEMCAL Reference Serum 1 bottle
AWDT Control 1 1 bottle
AWDT Control 2 1 bottle
Reagent Grade Deionized Water 1bottle
Class A volumetric pipettes, 3 and 5 ml 1 set
Household Bleach, unscented 10 mL
(5.25% sodum hypochlorite)

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4.2 Positioning and Connecting the Modules

The site chosen for the instrument should be large enough to provide adequate access
to all system components and be free from exposure to unusual temperature
fluctuations.
For detailed information, consult the site survey available from Technical Support.

4.2.1 Site Selection

The Analyzer requires approximately 0.9 m2 (10 sq ft.) of bench space. For easy
operator access, the system should be located 75 to 90 cm (30 to 35 inches) above the
floor on a clean, firm, level bench top. The bench should be free of excessive vibration
from equipment such as a centrifuge or compressor. Position the instrument as far away
as possible from any source of strong magnetic fields. Other considerations in selecting
a site include:
Accessibility – Select a location that will not hinder the operation of the system
or interfere with the operation of other equipment in the immediate work area.
The operator should also have easy access to supplies and other related
equipment.
Environment – Select a location that is free from wide fluctuations in
temperature. Do not, for example, locate the instrument next to a source of heat
or air conditioning or in direct sunlight. Verify that the following conditions are
met:
?? Ambient temperature is between 15 ?C (59 ?F) and 32 ?C (89.6 ?F).
?? Relative humidity is 20% to 80%, non-condensing.

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4.2.2 Physical Dimensions and Space Requirements

The dimensions of the analyzer, workstation components and uninterruptible power

supply (UPS) are as follows:

Analyzer Printer
Height 58.4 cm (23.0 in.) Height 20.0 cm (7.9 in.)
Width 69.9 cm (27.5 in.) Width 35.5 cm (14.0 in.)
Depth 57.2 cm (22.5 in.) Depth 39.5 cm (15.6 in.)
Raised Height 95.3 cm (37.5 in.)
Weight 64 kg (145 lb.)

UPS/Line
Conditioner
Height 8.9 cm (3.5 in.)
Width 43.8 cm (17.3 in.)
Depth 49.5 cm (19.5 in.)

The recommended minimum clearances are as follows:

?? Analyzer – Maintain a clearance of 7.6 cm (3.0 inches) behind the analyzer for
proper air flow through the exhaust vent and for cable connections. A space of
15.2 cm (6.0 inches) should be left free at either side of the analyzer to allow for
air circulation and to allow for easy access to replace the air filter and remove
cuvette waste. A space of 95.3 cm (37.5 inches) to raise the deck.
?? Printer – Maintain a clearance of 15 cm (6 in.) at the rear for the printer output
tray.
?? UPS/ Line Conditioner – Maintain a clearance of 7.6 cm (3.0 inches) at rear for
cable connections.

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4.2.3 Electrical Service

The ACE Alera System requires electrical service that provides power at the rated
voltage and frequency. Consult section 2.8 for absolute power requirement values.
The power source for the modules (UPS, analyzer, and printer) should be isolated,
dedicated and “clean”and free of transients and excessive voltage variations.

? Note: Consult a local electrician if you are uncertain about the adequacy of
your electrical service.

4.2.4 Positioning of Modules

Position the ACE Alera System modules as shown in Figure 13.

4.2.5 Connecting the Modules

All cable connections for the modules are provided with the system.
To protect the system from a power failure, connect the power cord from the analyzer
into the uninterruptible power supply (UPS). The UPS also provides line conditioning.
Connect the UPS power cord into the electrical supply outlet. Connect the printer power
cord directly to a power outlet.

WARNING: Printer power must not be connected to the UPS. Connecting

printer power to the UPS will cause premature discharge of the UPS
batteries.

Routing of the power cables from the analysis module and printer to the UPS and routing
of the communication cable from the analyzer to the printer are shown in Figure 13.

Figure 13. Module Interconnections

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4.3 Software Installation

Software for the system is loaded in the computer when the system is shipped. When
the power is turned on, the software code is downloaded until the Main menu (see page
21) is displayed on the monitor.
Disks containing the system software are provided for use in the event that the software
must be re-loaded. The following disks are provided:
?? Installation Disks (Disk 1 and Disk 2) – Installs the operating software.
?? Setup Disk – Installs test parameters, reagent bottle information, and other basic
information that is required to run each test.

? Note: During routine operation of the system, it should not be necessary

to reload the software. However, certain circumstances such as the
replacement of the hard disk drive may necessitate that the software be
re-loaded.

4.3.1 Re-Loading the Operating Software

1 With the Main menu displayed, type X to exit DOS, then turn off the power
to the system at the UPS.
2 Insert Installation Disk 1 into drive A.

?? Note: Be sure to wait at least 20 seconds before turning the

power to the UPS back on. Power on the computer if necessary.
3 Turn the power to the UPS on. The screen prompt DO YOU WISH TO
CONTINUE WITH THE INSTALLATION ?Y/N?? is displayed.

4 Press the Y key, then press Enter.

5 At the screen prompt, remove Installation Disk 1, insert Installation Disk 2,

and press any key.
6 Follow the screen prompts and press a key when instructed to do so.
7 At the screen prompt, remove Installation Disk 2.
8 Turn the power off at the UPS, wait 20 seconds, then turn the power on at
the UPS.

? Note: It will take about five minutes for the system to boot and
display the Main menu.

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4.3.2 Re-Loading the Setup Information

The Setup Disk contains database information such as test parameters and reagent
bottle information. If the setup information has been previously customized and backed
up (copied) to a disk, the information from the backup disk should be loaded instead.
Refer to page 170 for the procedure to restore the backup disk information.

? Important: Setup data contained on the backup disk will overwrite any current
system files. As a result, chemistry calibration data, patient data and control
data that were entered after the backup disk was prepared will be lost.
Daily backup of system data onto a disk will minimize the loss of chemistry
calibration data, patient data or control data in the event of a hard disk failure.

4.4 Container Installation

System diluent and system waste containers must be installed before operating the
system.
For systems containing the optional ISE module, CAL-A, CAL-B and Reference Solution
containers must also be installed before operating the system.
Refer to section 5.5 for instructions.

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4.5 ISE Installation

The ISE module is an optional module for the ACE Alera System which adds
potentiometric tests for sodium, potassium and chloride to the test menu.
The ISE module is contained within the analyzer and does not require additional bench
space. Setting up the ISE module entails:
?? Enabling the ISE Module
?? Installing the ISE Tubing
?? Assembling the Electrodes

? Note: Installation and connection of the ISE module is to be performed

only by an authorized Alfa Wassermann Diagnostic Technologies, LLC
representative. Installation procedures are provided for reference
purposes only.

4.5.1 Enabling the ISE Module

The ISE module must first be enabled on the system and the calibration mode set. Refer
to page 181 for instructions on enabling the ISE. Refer to page 182 for instructions on
setting the ISE calibration mode.

? Note: An ATTENTION warning will be displayed because the ISE calibrators

have not been configured. Ignore the warning.

4.5.2 Installing the ISE Tubing

Five prepared tubing assemblies and six separate tubing segments must be installed.
These can be obtained from your Alfa Wassermann Diagnostic Technologies, LLC
representative:

Prepared Tubing Assemblies Part Number

Tubing Set, Pump 906182
Cap, CAL-B Bottle Assembly (red) 27-11283
Cap, Reference Bottle Assembly (white) 27-11282
Measuring Chamber Waste Tubing Assembly, 330 mm (13.0 in., black 39-11965
banded) included in the ISE Reference and Sample Tubing Kit
P/N 402771
Reference Housing Outlet Tubing Assembly, 305 mm (12.0 in., yellow 39-11966
banded) included in the ISE Reference and Sample Tubing Kit
P/N 402771

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Tubing Segments Part Number

Reference Housing Inlet Tubing Assembly, 273 mm (10.75 in., 505119-1
dark blue banded) included in the ISE Reference and Sample Tubing
Kit P/N 402771
Measuring Chamber Inlet Tubing, 64 mm (2.5 in., purple banded) 505118-1
included in the ISE Silicone Tubing Kit P/N 402770
Sample Transport Tubing, 216 mm (8.5 in., green banded) (same as 505118-3
Waste Transport Tubing) included in the ISE Silicone Tubing Kit
P/N 402770
CAL A Transport Tubing, 254 mm (10 in., red banded) included in the 505118-4
ISE Silicone Tubing Kit P/N 402770
Waste Transport Tubing, 216 mm (8.5 in., green banded) (same as 505118-3
Sample Transport Tubing) included in the ISE Silicone Tubing Kit
P/N 402770
Air Inlet Tubing, 89 mm (3.5 in., light blue banded) included in the ISE 505118-2
Silicone Tubing Kit P/N 402770

When installing the ISE tubing, remove the tubing assemblies and tubing segments from
the packaging and replace it on the instrument one at the time.

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Displaying the Pump and Valve Operation Screen

1 Select Diagnostics from the Main menu. The Diagnostics menu is

displayed.
2 Select Troubleshooting from the Diagnostics menu. The Troubleshooting
menu is displayed.
3 Select ISE from the Troubleshooting menu. The Troubleshoot ISE menu is
displayed.
4 Select Operate Valves/Pump. The Pump and Valve Operation screen is
displayed.

? Note: The Valve and Pump Operation screen is used in the

following sections when installing the remainder of the ISE
tubing.

Installing the Peristaltic Pump Tubing

1 Orient the plastic plate so that the smaller (narrower) end is closest to the
rear of the ISE Module.
2 Loop the peristaltic pump tubing (P/N 27-11719) around the pump rollers
(Figure 14). The tubing should remain parallel and should not cross.

? Note: Do not install the pump tubing plate on the pump tubing
plate bracket at this time.

Figure 14. Installation of Peristaltic Pump Tubing

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Installing the Air Inlet (3.5 inch, Light Blue Banded Silcone Rubber) Tubing

1 Select AIR: and press the insert key to open the air valve.
2 Loop the air inlet tubing (P/N 23-11730) around the air valve (Figure 15).
Pull on both ends of the tubing until it snaps into the valve.
3 Pull the tubing through the valve, leaving a small length at the top of the
valve to secure in the retainer.

? Important: The section of tubing that is pinched shut by the

valve may not fully open after repeated use. To prolong the life
of the tubing, slightly reposition the tubing once a month so that
a different section is pinched shut.

4 Attach the other end to the far right hand port of the fluid manifold. There
should not be tension on the tubing when attached.
5 Press the insert key to close the air valve.

Figure 15. Installation of Air Inlet Tubing

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Installing the CAL-B (Red) Cap Assembly

1 Select CAL-B and press insert key to open the CAL-B valve.
2 Loop the CAL-B cap assembly tubing (P/N 27-11283) around the CAL-B
cap valve (Figure 16). Pull on both ends of the tubing until it fully seats into
the valve.
3 Pull the tubing through the valve. Attach the end of the tubing to the
second inlet port from the right on the fluid manifold.

? Important: The section of tubing that is pinched shut by the

valve may not fully open after repeated use. To prolong the life
of the tubing, slightly reposition the tubing once a month so that
a different section is pinched shut.

4 Pull the tubing back through the valve to remove excess slack. There
should not be tension on the tubing when attached.
5 Press the insert key to close the CAL-B valve.

Figure 16. Installation of CAL-B Cap Assembly

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Installing the Waste Transport (8.5 inch, Green Banded Silcone Rubber) Tubing

1 Attach one end of the waste transport tubing (P/N 23-11730) to the
stainless steel tube labeled WASTE.

? Note: The stainless steel WASTE tube is located at the top of

the back wall nearest the left side of the module.

2 Press the tubing into the rear-most pair of retaining clips on the top of the
module.
3 Attach the free end to the right rear port of the pump plate (Figure 17).

Figure 17. Installation of Waste Transport Tubing

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Installing the CAL-A (10.0 inch, Red Banded Silcone Rubber) Transport Tubing

1 Select CAL-A and press the insert key. The CAL-A valve opens.
2 Loop the CAL-A transport tubing (P/N 23-11730) around the CAL-A valve.
Pull on both ends of the tubing until it fully seats into the valve.
3 Attach the end of the tubing protruding from the bottom of the valve to the
second inlet port from the left on the fluid manifold (Figure 18).
4 Pull the tubing back through the valve to remove the slack between the
fluid manifold and the valve. There should not be tension on the tubing
when attached.

? Important: The section of tubing that is pinched shut by the

valve may not fully open after repeated use. To prolong the life
of the tubing, slightly reposition the tubing once a month so that
a different section is pinched shut.

5 Attach the other end of the tubing to the stainless steel tube labeled
CAL-A at the top of the back wall of the module.
6 Secure the tubing in the second pair of tubing retaining clips from the rear
on the top of the module.
7 Press the insert key to close the CAL-A valve.

Figure 18. Installation of CAL-A Transport Tubing

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Installing the Sample Transport (8.5 inch, Green Banded Silcone Rubber) Tubing

1 Select SAMPLE and press the insert key. The sample valve opens.
2 Loop the sample transport tubing (P/N 23-11730) around the sample
valve. Pull on both ends of the tubing until it fully seats into the valve.
3 Attach the loose end protruding from the bottom of the valve to the first
inlet port on the left of the fluid manifold (Figure 19).
4 Pull the tubing back through the valve so that there is minimum slack
between the fluid manifold and the valve. There should not be tension on
the tubing when attached.

? Important: The section of tubing that is pinched shut by the

valve may not fully open after repeated use. To prolong the life
of the tubing, slightly reposition the tubing once a month so that
a different section is pinched shut.

5 Attach the other end of the tubing to the stainless steel inlet port on the
upper left of the ISE Module marked Sample. Push the tubing
approximately 6 mm (1/4 inch) onto the port.
6 Secure the tubing in the third retaining clip from the rear on the top of the
module.
7 Press Insert to close the sample valve.

Figure 19. Installation of Sample Transport Tubing

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Installing the Measuring Chamber Waste (13 inch, Black Banded) Tubing

1 Attach the end of the measuring chamber waste tubing assembly

(P/N 39-11965) with the shorter coupler to the port on the left side of the
measuring chamber (Figure 20).
2 Slide the measuring chamber into the rails part way.
3 Route the tubing assembly upward, securing the first segment of black
tubing into the tubing retaining clip on the side wall of the ISE module.
Ensure there are no kinks in the tubing.
4 Continue to route the tubing along the top of the module. Secure the
tubing in the pair of retaining clips located fourth from the rear of the
module. Be sure to snap the black segments into the clips.
5 Route the remaining end of the tubing assembly downward and attach it to
the left port of the pump plate.

Figure 20. Installation of Measuring Chamber Waste Tubing

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Installing the Measuring Chamber Inlet (2.5 inch, Purple Banded Silicone) Tubing

1 Move the measuring chamber forward for easier access. Attach one end
of the measuring chamber inlet tubing assembly (P/N 23-11730) to the
port on the right side of the measuring chamber.
2 Slide the measuring chamber back on its rails until it snaps in place.
3 Connect the other end of the tube to the horizontal port protruding from the
left end of the fluid manifold (Figure 21).
4 Reconnect the sample sensor cable by inserting the plastic connector into
the receptacle above the measuring chamber.

Figure 21. Installation of Measuring Chamber Inlet Tubing

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Installing the Reference Housing Outlet (12 inch, Yellow Banded) Tubing

1 Connect the unmarked end of the reference housing outlet tubing

(P/N 39-11966) to the left port of the ISE Reference reservoir.
2 Route the tubing along the top of the module and secure it in the retaining
clips.
3 Connect the other end of the yellow-banded tubing to the yellow-marked
port on the reference housing when it is installed (see page 71).

Figure 22. Installation of Reference Housing Outlet Tubing

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Installing the Reference Housing Inlet (10.75 inch, Dark Blue Banded) Tubing

1 Attach the tube to the right port at the front of the pump plate (Figure 23).
2 Route the tubing toward the top of the ISE module. Secure it in the front
pair of retaining clips.
3 Connect the other end of the tubing to the unmarked port on the reference
housing when it is installed (see page 71).

Figure 23. Installation of Reference Housing Inlet Tubing

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Installing the Reference Solution (White) Cap Assembly

1 Connect the yellow-banded tubing to the right tubing port of the Reference
reservoir (Figure 24).
2 Connect the other tube to the left front port of the peristaltic pump plate.
3 Pull upward on the pump plate, stretching the silicone tubing, and engage
the plate in the pump plate bracket. The pump tubing should remain
parallel and should not be allowed to cross.
4 Make sure that the smaller (narrower) end of the pump tubing bracket is
closest to the rear of the ISE module.

Figure 24. Installation of Reference Solution Cap Assembly

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4.5.3 Electrode Installation

After all of the ISE tubing is installed, the reference electrode housing is installed into the
measuring chamber. The reference electrode and the three ion-selective electrodes are
then inserted into the measuring chamber.

Installing the Reference Electrode Housing

1 Open the Container Access door.

2 Pinch the plastic tabs on either side of the measuring chamber. Pull the
chamber forward.
3 Verify that an o-ring is installed in the center on the right side of the
electrode holder.
4 Unclamp the left electrode holder by rotating the clamp forward.
5 Remove the reference electrode housing from its box and make sure that
an o-ring has been installed in the left side.
6 Place the reference electrode housing in the measuring chamber next to
the left electrode holder.
7 Connect the clear tubing with the yellow band to the yellow-marked port on
the reference housing.

? Note: The tubing should have a tight fit. However, it must be

pushed all the way onto the housing tubing connector.

8 Connect the clear tubing without the yellow band to the unmarked port on
the reference housing.

? Note: The tubing should have a tight fit. However, it must be

pushed all the way onto the housing tubing connector.

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Installing the Electrodes

1 Remove the reference electrode from its box and unscrew it from the red
transport housing.
2 Make sure that the o-ring on the reference electrode is properly seated.
3 Carefully screw the reference electrode into the reference housing. Do not
overtighten.

? Note: Rinse the transport housing and save it for storage of the
reference electrode and for use during maintenance of the
reference housing.

4 Remove the sodium electrode from its box. Make sure an o-ring is present
and that is properly seated on the left side.
5 Install the electrode next to the reference electrode assembly.

6 Remove the potassium electrode from its box. Make sure an o-ring is
present and that it is properly seated on the left side.
7 Install the electrode next to the sodium electrode.
8 Remove the chloride electrode from its box. Make sure that an o-ring is
present and that it is properly seated on the left side.
9 Install the electrode next to the potassium electrode.
10 Make sure that the bottom lip of each electrode rests on the flat edge of
the measuring chamber.
11 With one hand holding the electrodes in place, close the clamp on the left
electrode holder by lifting it upward until it locks in the closed position.

? Note: Save the box that each electrode was packaged in. They
can be used for future storage of the electrodes.

12 Push the measuring chamber back until it snaps into the engaged position.

13 If the sample sensor cable was removed for any reason, reconnect the
cable.

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4.5.4 ISE Reagents

Loading CAL-A, CAL-B and ISE Reference Solution

Refer to pages 98 through 100 for instructions.

Priming ISE Lines

1 Display the Pump and Valve Operation screen (see page 60).
2 Select AIR: and press the spacebar to operate the pump and valve.

3 Verify that reference solution flows from the reference container into the
lines, through the reference electrode housing, up to the ISE Reference
Reservoir and out of the ISE Reference Reservoir back into the reference
solution container.

? Note: The fluid sensor field on the screen should change from
LIQUID to AIR.
4 Press the spacebar to stop the pump.
5 Select CAL-A and press the spacebar to operate the pump and valve.

6 Observe the fluid sensor for CAL A flow.

7 When CAL A appears in the fluid sensor, press the spacebar to stop the
pump.

? Note: The fluid sensor field on the screen should change from
AIR to LIQUID.

? Note: It should take approximately 5-7 seconds for CAL-A to appear.

8 Select AIR and press the spacebar.

9 Verify that air flows into the manifold and lines and that small drops of
reference solution are dripping into the sample path section of the
reference housing.

? Note: The fluid sensor field on the screen should change from
LIQUID to AIR.
10 Press the spacebar to stop the pump.
11 Select CAL-B and press the spacebar to operate the pump and valve.
12 When CAL-B appears on the fluid sensor, press the spacebar to stop the
pump.

? Note: The fluid sensor field on the screen should change from AIR
to LIQUID.

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13 Select SAMPLE and press the spacebar.

14 Verify that air flows from the sample line through the manifold and into the
electrodes. Also verify that reference solution is dripping into the fluid
measurement path of the reference housing.

? Note: The drip rate should be approximately one drop every one to five
seconds. The time between successive drops should be consistent within
one second. Use a flashlight to observe drops from the reference housing
into the sample fluid flow path.

? Note: The fluid sensor field on the screen should change from LIQUID to
AIR.

15 Press the spacebar to stop the pump.

16 Close the container access door.
17 Press Esc until the Diagnostics menu is displayed.

Verifying Fluid Flow

1 Select CAL-A and press the spacebar to operate the pump and valve.
2 Verify that CAL-A solution is flowing into manifold, through the lines, and
into the electrode chamber.
3 Verify that no air bubbles are present.
4 Press the spacebar to stop the pump.
5 Select AIR and press the spacebar.
6 Verify that no fluid droplets are present.
7 Pump the following fluids and verify the observations.

Fluid Observation
CAL-B No air bubbles seen.

SAMPLE No fluid drops seen.

AIR No fluid drops seen.

8 Press the spacebar to stop the pump.

9 Close the container access door.
10 Press Esc until the Diagnostics menu is displayed.

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4.5.5 Liquid Sensor Calibration

The liquid sensor must be calibrated before the ISE can be run.

1 Select Hardware Calibration from the Diagnostics menu.

2 Select ISE from the Hardware Calibration menu. The calibration functions
are displayed.
3 Select Liquid Sensor.
4 When the calibration is complete, press Esc until the Main menu is
displayed.

4.5.6 Cleaning, Conditioning and Calibration

The electrodes must be cleaned, conditioned and calibrated each day before tests are
run. Refer to the Maintenance section for the procedures.

? Note: After the cleaning and conditioning cycles are completed, a

calibration must be performed and a calibration report printed. When all
three channels have been successfully calibrated, the ISE is ready to
analyze samples.

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5 Daily Preparation for Operation

Daily preparation of the system for running tests is summarized below:

5.1 Daily Maintenance

Perform daily maintenance:

Procedure Page

(DM-1) Remove Condensation from Reagent Compartment 229

(DM-2) Clean Wash Bath and Probe Pathway 230

(DM-3) Clean Exterior of Probe 231

(DM-4) Check Probe Alignment 232

(DM-5) Clean and Condition ISE 233

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5.2 Checking Status

5.2.1 Power

Verify that the power switches to the UPS, analyzer, and printer are ON.

? Note: The power to the UPS and analyzer should remain ON at all times
except when performing maintenance or service.

5.2.2 Checking Reagent Tray Status

The Reagent Tray Status screen lists the following:

?? Reagent bottles that are currently loaded on the tray
?? The volume (in mL) remaining in each reagent bottle
?? The approximate number of tests remaining in each reagent bottle
?? The position of each reagent bottle on the tray
?? Reagent bottles that are required for a pending requisition on an active sample
?? The remaining working lifetime (in hours) of each reagent bottle
?? The lot number of each reagent bottle

When the working lifetime of a reagent bottle is reached, the reagent bottle is designated
as EXPIRED on the Reagent Tray Status screen and the bottle will no longer be used by
the system.

? Note: If the working lifetime of a reagent bottle is reached while tests are
being run on the system, any remaining tests that require that reagent will
be placed on hold.

1 (If needed) Press F3 to display the Status menu:

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2 Select Reagent tray. The Reagent Tray Status screen is displayed:

3 Verify that:

? ? The required reagents are on the tray.

? ? The volume of each reagent is sufficient.
? ? The working lifetime of each reagent has not expired (or will not
expire before the workload is completed).

? Note: Make note of any reagents that must be replaced or added

and any reagent bottles that should be removed.
In the example above, the glucose reagent bottle at position 11 has
reached the end of its working lifetime hours (EXPIRED is shown in
the Volume field for that bottle, and the Hours field is “zero”), and
the BUN reagent bottle at position 15 has run out (UNUSABLE is
shown in the Volume field for that bottle). Both reagents must be
replaced.

4 Press Esc to return to the Status menu.

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5.2.3 Checking Calibration Status

The Calibration Status screen displays the state of each photometric test requiring
calibration.

? Note: Calibration states are NO CAL, NEW LOT, CAL PENDING, CAL
PASSED, CAL FAILED, or CAL EXPIRED.

1 (If needed) Press F3 to display the Status menu:

2 Select Calibration. The Calibration Status screen is displayed:

3 Check the calibration status of each test. Note any tests that will require
calibration.
Note: Any request for a test without a valid calibration will be put on
? hold. In the example above, the DBILI calibration has expired and
DBILI test requests will be put on hold until the DBILI calibration is
successfully completed.

4 Press Esc to return to the Status menu.

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5.2.4 Checking Tests On Hold

The On-Hold Status screen lists any tests that are on hold. A test is on hold if a
component that is required to complete the test is not available at the time the sample is
loaded.

1 (If needed) Press F3 to display the Status menu:

2 Select On-hold. The On-Hold Status screen is displayed:

? Note: Note any tests that are on hold so that the appropriate action
may be taken to complete the test.

3 Press Esc to return to the Status menu.

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5.2.5 Checking Sample Ring Status

The Sample Ring Status screen lists the following information:

?? Segments on the sample ring (if any)
?? Location (by section) of each segment
?? Type of segment (well or cup)
?? Segment number (if applicable)
?? Status (clean, active, inactive, done, usable)
Selecting a specific segment displays the status (CLEAN, ACTIVE, DONE, USABLE,
UNKNOWN, VACANT, EXPIRED, or SHORT) of each sample or position on that
segment.

1 (If needed) Press F3 to display the Status menu:

2 Select Sample ring. The Sample Ring Status screen is displayed:

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3 To view the details for a sample ring section, select the section using the
arrow keys and then press ENTER:

4 Verify that the required number of well segments and cup segments are
available.

? Note: Well segments are used for samples loaded from tubes placed
in the STEP Module and for automatic dilution of samples. Cup
Segments are used for samples transferred to sample cups for
placement on the system including calibrators, controls and patient
samples. A cup segment with a status of CLEAN has positions
available to accept sample cups from the Patient Requisition Screen.

5 Press Esc to return to the Status menu.

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5.2.6 Checking Hopper Status

The Hopper Status screen displays the number of cuvettes remaining in the hopper, the
number of cuvettes in each of the 20 slots and the number of empty slots.

1 (If needed) Press F3 to display the Status menu:

2 Select Hopper. The Hopper Status screen is displayed:

3 Verify that sufficient cuvettes are loaded.

? Note: Fill the hopper at the beginning of the day to avoid

interruption later.

4 Press Esc to return to the Status menu.

? Note: Press Esc again to return to the Main menu.

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5.2.7 Checking Database Status

The Database Status screen lists the capacity of various system parameters by number
remaining, number used and maximum number allowed.

1 (If needed) Press F3 to display the Status menu:

2 Select Database. The Database Status screen is displayed:

3 Note if data should be purged prior to beginning the workload.

? Note: When the number of requisitions or patients approaches

the maximum (5,000 requisitions or 1,000 patients), deleting of
patient data is recommended (refer to page 171).

4 Press Esc to return to the Status menu.

? Note: Press Esc again to return to the Main menu.

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5.3 Loading Consumables

5.3.1 Loading the Cuvette Hopper

1 Press Fn and F2 to display the Access menu:

2 Select Hopper.
3 The message Preparing for hopper access… is briefly displayed before
instructions for inserting cartridges are displayed:

4 Obtain a full cuvette cartridge.

? Note: A full cuvette cartridge (Figure 6) contains 20 cuvettes, with

ten of the cuvettes located at one end of the cartridge and the
other ten cuvettes located at the other end of the cartridge.

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5 Grasp the cuvette cartridge at the top of one end, with the cuvettes facing
towards you (Figure 25).

6 Verify that the Hopper Access indicator is displayed (see Figure 12 on

page 19). When the indicator is illuminated, carefully slide the end of the
cartridge into the hopper until it stops.

? Important: Always wait for the Hopper Access indicator to be

displayed before sliding the cartridge into the hopper.

7 Remove the cartridge and verify that 10 cuvettes have been removed from
the cartridge.

? Note: After the ten cuvettes are loaded, the hopper will advance to
the next available slot and the indicator will illuminate.
If the system detects that less than 10 cuvettes have been loaded, it
will display a warning message. If this occurs, respond to the screen
prompt or troubleshoot the problem.

8 Turn over the cuvette cartridge and grasp the top with the cuvettes facing
towards you.
9 Carefully slide the cartridge into the hopper until it stops.

10 Remove the cartridge and verify that the remaining ten cuvettes have
been removed from the cartridge.
11 Repeat Steps 4 through 10 until the desired number of cuvettes has been
loaded.

Figure 25. Loading Cuvettes from the Cuvette Cartridge

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5.3.2 Loading Clean Well Segments

Well segments are used for samples that are loaded from tubes placed in the STEP and
for automatic sample dilutions on the instrument.

? Note: A well segment contains three disposable seglets, each containing ten
wells (see Figure 8 on page 13). Three clean seglets must be placed in the
well segment before it is loaded on the system.
At least one clean well segment should be loaded on the system before
starting a run. The total number of well segments required depends upon the
workload and how the samples will be loaded.
To unlock the segment door, perform the following steps:

1 Press Fn and F2 to display the Access menu:

2 Select Segment to display the Segment menu:

3 Select Place to display the Place menu:

4 Select Well. The messages Pausing the Instrument… and Positioning

the sample ring… are briefly displayed before instructions for inserting
well segments are displayed and the segment door lock is disengaged:

5 Obtain a well segment loaded with three clean seglets.

? Note: A complete well segment contains three seglets. Each

seglet contains ten wells.

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6 Place the full well segment on the outer portion of the reagent tray,
ensuring that the well segment is securely on the posts (Figure 26).
7 Close the access cover.
8 Press F10.
9 Repeat the entire procedure to load another well segment.

Figure 26. Loading Well Segments

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5.3.3 Loading Empty Cup Segments

Empty cup segments are used to accept sample cups that are individually loaded during
creation of a patient requisition or a control requisition.

? Note: At least one clean cup segment should be loaded on the system before
starting a run. The total number of cup segments required depends upon the
workload and how the samples are loaded.

To unlock the segment door, perform the following steps:

1 Press Fn and F2 to display the Access menu:

2 Select Segment to display the Segment menu:

3 Select Place to display the Place menu:

4 Select Cup. The messages Pausing the Instrument… and Positioning

the sample ring… are briefly displayed before instructions for inserting
cup segments are displayed and the segment door lock is disengaged:

5 Obtain an empty cup segment.

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6 Place the empty cup segment on the outer portion of the reagent tray,
ensuring that the cup segment is securely on the post (Figure 27).

7 Close the access cover.

8 Press F10.
9 Repeat the entire procedure to load another cup segment.

Figure 27. Loading Empty Cup Segments

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5.4 Loading Reagents

Caution: Refer to the appropriate Material Safety Data Sheet

(MSDS) for information concerning any precautions to be taken in
handling individual reagents.

5.4.1 Preparing Reagents

Consult the package insert that accompanies each reagent for instructions concerning
the storage and preparation of the reagent before it is placed on the system.
Before placing a reagent on the system, replace the cap with an Evap-Cap:

1 Remove the cap from the reagent bottle.

2 Ensure the top of the bottle is dry and that no large bubbles are present
within the neck of the bottle.

3 Peel an adhesive-backed Evap-Cap from the supplied strip (Figure 28).

4 Press the Evap-Cap onto the bottle neck opening.

? Note: The Evap-Cap minimizes evaporation and upholds integrity while

the reagent is in the Reagent Compartment. Additional Evap-Caps can be
obtained from your Alfa Wassermann Diagnostic Technologies, LLC
distributor.

Figure 28. Placing an Evap-Cap

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5.4.2 Loading Reagents

To unlock the reagent door, perform the following steps:

1 Press Fn and F2 to display the Access menu:

2 Select Reagents. The message Preparing for Reagent Access… is

briefly displayed before instructions for loading reagents are displayed and
the reagent door lock is disengaged:

3 Obtain the reagents that are needed.

? Note: Be sure that the hard plastic caps have been removed and
replaced with paper Evap-Caps.

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4 Carefully remove and/or insert reagent bottles as required. Be sure that

each bottle is fully seated on the tray.

? Note: Place the reagent bottles anywhere on the ring, with large
bottles in the outer ring and small bottles in the inner ring. The
dot-coded label on the bottom of the bottle identifies each of the
reagents on the analyzer.
If a reagent bottle does not contain sufficient volume to complete
the workload, a second bottle can be placed on the system before
the run is started. The new reagent bottle will be held in reserve
until reagent in the first bottle is depleted. The system will then
automatically switch to the second bottle.

5 Close the reagent access cover.

6 Press F10.

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5.5 Replenishing Solutions

? Note: System sensors monitor the fluid level in the waste, system diluent,
CAL-A, and CAL-B containers. Servicing the containers at the beginning of the
day avoids an interruption in workflow.

5.5.1 Accessing Solution Containers

1 Press Fn and F2 to display the Access menu:

2 Select Containers. The message Preparing for Container Access… is

briefly displayed before instructions for loading containers are displayed:

3 Open the Container Access Door on the left side of the analyzer
(Figure 29).

Cuvette Waste
Box
ISE CAL A
System Diluent
Liquid Waste
Container

Figure 29. Storage of System Fluids and Waste

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5.5.2 Emptying System Waste

Biohazard: Material in the ACE Alera System waste container may

be classified as biohazardous. Handle cautiously in accordance with
laboratory safety rules and local regulations.

1 Check the level of waste. If needed, empty the waste container as

described in the following steps.
2 Remove the waste container from the compartment by sliding it out.
3 Press the metal release button and then remove the cap assembly from
the waste container (Figure 30).
4 Empty the contents of the waste container.

? Note: Dispose of the waste according to your facility

regulations.

5 Rinse the waste container and cap with tap water.

6 Place 10 mL of household bleach in the container.
7 Replace the waste container cap assembly and snap the tube in place.
8 Slide the waste container forward into its position in the compartment.

Metal Release
Button

Figure 30. Removal of Waste Cap

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5.5.3 Replacing System Diluent

1 Check the level of system diluent. Replace the system diluent if there is
less than 1/4 inch of liquid in the container.
2 Remove the system diluent container from the compartment by tilting the
bottom of the bottle up and then sliding it out.
3 Press the metal release button on the tubing (next to the cap) and then
disconnect the tubing (Figure 31).
4 Unscrew the used system diluent container from the cap assembly. Set
the cap aside.
5 Remove the cap from a new container of system diluent. Discard the cap.
6 Place the system diluent cap assembly into the new system diluent
container and tighten it. Reinsert the tubing into the cap.
7 Tilt the system diluent container and gently slide it up and forward into the
compartment.

? Note: The label on the system diluent container and the metal
guide on the cap should be facing the liquid waste container.

Metal Release
Button

Figure 31. Removal of System Diluent Tubing

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5.5.4 Replacing ISE CAL-A

1 Check the level of ISE CAL-A. Replace CAL-A if there is less than 1/4 inch
of liquid in the container.

? Note: The following section is only applicable if your system

contains the optional ISE module.

2 Remove the ISE CAL-A container from the compartment by tilting the
bottom of the bottle up and then sliding it out.
3 Twist the tubing connector on the tubing (next to the cap) counter-
clockwise and then disconnect the tubing (Figure 32).
4 Unscrew the used ISE CAL-A container from the cap assembly. Set the
cap aside.
5 Remove the cap from a new container of ISE CAL-A. Discard the cap.
6 Place the ISE CAL-A cap assembly into the new ISE CAL-A container and
tighten it. Reinsert the tubing into the cap
7 Tilt the ISE CAL-A container and gently slide it up and forward into the
compartment.

? Note: The label on the CAL-A container should be facing the

system diluent container, and the metal guide on the cap
should be facing the analyzer.

Figure 32. Removal of ISE CAL-A Tubing

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5.5.5 Replacing ISE CAL-B

1 Check the level of ISE CAL-B. Replace CAL-B if there is less than 1/2 inch
of liquid in the container.

? Note: If CAL-B and Reference Solution both need to be

replaced, replace the CAL-B before replacing the Reference
Solution.
The ISE system is optional. Your system may not contain ISE
electrodes or require ISE reagents.

2 Remove the Reference Solution and CAL-B containers from the system.
3 Clean the ISE Module, removing any salt deposits or spills.
4 Remove any salt deposits from the cap assemblies on the ISE Reference
Solution and ISE CAL-B containers.
5 Obtain a new container of ISE CAL-B and remove the cap.
6 Carefully remove the entire foil seal (including the foil on the rim of the
container) to ensure a good seal.
Important: Be careful not to contaminate the fluid in the container.
? Clean the tool before using it to break the foil seal on the container.

7 Unscrew the ISE CAL-B cap assembly from the used ISE CAL-B container
and transfer it to the new ISE CAL-B container. Screw on the ISE CAL-B
cap assembly until it is tightened.

?
Important: Do not allow the CAL-B aspiration tube to contact
Reference Solution, dried salt deposits, or any surface. Be sure
to use the red cap assembly with ISE CAL-B.

8 Discard the used ISE CAL-B container.

9 Gently slide the ISE CAL-B container assembly into the rear position of the
module.
10 Return the Reference Solution to its place in front of the CAL-B container.

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5.5.6 Replacing ISE Reference Solution

1 Check the level of ISE Reference Solution. Replace Reference Solution if

there is less than 1/2 inch of liquid in the container.

? Note: If CAL-B and Reference Solution both need to be

replaced, replace the CAL-B before replacing the Reference
Solution.
The ISE system is optional. Your system may not contain ISE
electrodes or require ISE reagents.

2 Remove the Reference Solution container from the system.

3 Clean the ISE module, removing any salt deposits or spills.
4 Remove any salt deposits from the cap assembly on the ISE Reference
Solution container.
5 Obtain a new container of ISE Reference Solution and remove the cap.
6 Carefully remove the entire foil seal (including the foil on the rim of the
container) to ensure a good seal.

? Important: Be careful not to contaminate the fluid in the container.

Clean the tool before using it to break the foil seal on the container.

7 Unscrew the ISE Reference Solution cap assembly from the used ISE
Reference Solution container and transfer it to the new ISE Reference
Solution container. Screw on the ISE Reference Solution cap assembly
until it is tightened.

? Important: Be sure to use the white cap assembly with ISE

Reference Solution.

8 Discard the used ISE Reference Solution container.

9 Gently slide the ISE Reference Solution container into the front position on
the tray (in front of ISE CAL-B).

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5.6 Emptying the Cuvette Waste Box

Biohazard: Waste material from the ACE Alera System which may
be classified as biohazardous includes used cuvettes dispensed into
the cuvette waste box. Handle cautiously in accordance with
laboratory safety rules and local regulations.

Check the level of waste in the cuvette waste box . If the level of used cuvettes is
nearing the top, empty the box before starting the workload for the day.

? Note: A sensor monitors the level of used cuvettes and will indicate when
it is necessary to empty the waste box. Emptying the waste box at the
beginning of the day avoids a later interruption.

1 Press Fn and F2 to display the Access menu:

2 Select Containers. The message Preparing for Container Access… is

briefly displayed before instructions for emptying the waste box are
displayed:

3 Open the container access door on the left side of the analyser (see
Figure 29 on page 95).
4 Remove the waste box by pulling it out.
5 Remove the BIOBAG containing the used cuvettes from the waste box.
6 Seal the bag with one of the provided ties.
7 Dispose of the used cuvettes according to your facility regulations.

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8 Insert a new BIOBAG into the waste box, folding the top of the bag down
over the sides of the box.

? Note: A rubber band can be used to secure the BIOBAG in place.

Smooth out the BIOBAG inside the waste box to allow for
maximum capacity.

9 Slide the waste box back into the compartment.

10 Close the access door.

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6 Ordering Tests

Once the daily preparation has been completed, tests can be ordered.

A requisition must be prepared for each sample on which tests are to be run. Different
types of requisitions are used for patient samples, quality control samples, and
calibrators.

If a patient record is created and saved, tests are ordered on samples from that patient
by attaching a new test requisition or by adding the tests to an existing requisition.

6.1 Initiating a Patient Sample Requisition

Patient sample requisitions can be prepared in two ways (Figure 33). The minimum
information that is required for ordering tests on a patient sample is the Patient First
Name (if required), Patient Last Name, Patient ID, Accession (which can be
automatically assigned by the system), and the test(s) to be run.

New Patient Existing Patient

Enter Patient Select the

Information Patient
(See Section 6.1.1 (See Section 6.1.2
on page 104) on page 106)

Order Tests Order Tests

(See Section 6.2.1 (See Section 6.2.2
on page 109) on page 111)

Figure 33. Initiating a Patient Sample Requisition

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6.1.1 Initiating a Requisition for a New Patient

1 Select Patient from the Requisitions menu. A list of patients that have
already been entered into the system is displayed:

? Note: If no patients are entered into the system, a blank patient

requisition form is displayed.

2 Press Insert. The Patient Requisition form is displayed with the LAST
NAME: field selected:

3 Type the patient’s last name and press Enter. The FIRST NAME: field is
selected.

? Note: LAST NAME: and PATIENT ID: are required fields. The
FIRST NAME: field may also be required, depending on how your
system has been configured. These fields cannot be edited once
the requisition is saved in the database.

The Tab, Enter or down arrow keys will also advance the cursor
to the next field. Use the up arrow key to return to the previous
field.

4 Type the patient’s first name (if required) and press Enter. The PATIENT
ID: field is selected.

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5 Type the patient ID and press Enter. The DOB: field is selected.

? Note: The patient ID can contain up to 12 alphanumeric

characters.

6 Type the patient’s date of birth and press Enter. The SEX: field is
selected.

? Note: Enter the date of birth using the date format (MM/DD/YY or
DD/MM/YY) specified during system configuration. The AGE: field is
automatically filled in based on the entered date of birth.
If the DOB: field or any of the other remaining fields are to be left
blank, press Enter without typing any information in the field.
Press F6 at any time the cursor is in the upper section of the form to
advance the cursor to the ACCESSION: field.

7 Type M or F and press Enter. The DOCTOR: field is selected.

8 Type the doctor’s name and press Enter. The LOCATION: field is
selected.

? Note: If the doctor has not previously been entered in the system, a
prompt to add the new doctor is displayed.
If you prefer, press F2 to display a list of doctors that are on the
system, select the desired doctor and press Enter.

9 Type the location and press Enter. The COMMENT: field is selected.

? Note: The location can contain up to 6 alphanumeric characters.

10 Type a comment regarding the patient if desired and press Enter. The D/T
DRAWN: field is selected.

? Note: The comment can contain up to 39 alphanumeric

characters.

11 Proceed to Step 2 of Section 6.2.1 to order tests.

? Note: A Patient Requisition cannot be saved in the database until

the Patient Last Name, Patient ID, and Accession (which can be
automatically assigned by the system) are entered and at least one
test has been ordered. The Patient First Name may also be
required, depending on how your system has been configured.

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6.1.2 Initiating a Requisition for an Existing Patient

1 Select Patient from the Requisitions menu. A list of patients that have
already been entered into the system is displayed:

? Note: To locate a name quickly, the Patient list can be sorted by

entering the first character(s) of the name in the name field.
If the patient name is not listed, a record for the patient must be
created. Refer to page 104 for details.

2 Select the desired patient (using the arrow keys) and press Enter. A list of
requisitions for the patient is displayed:

3 Press Insert. A new requisition form for the patient is displayed with the
D/T DRAWN: field selected:

4 Proceed to Step 2 of Section 6.2.1 to order tests.

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6.1.3 Initiating Multiple Requisitions

The system can automatically generate multiple requisitions for the same test(s). Each
requisition has a unique Accession number and identical patient demographic
information.

1 Select Patient from the Requisitions menu. A list of patients that have
already been entered into the system is displayed.

2 Press Insert. The Patient Requisition form is displayed.

3 Enter the patient demographics (refer to section 6.1.1).

4 Select the ACCESSION: field (using the arrow keys) and type a number
range.

? Note: Use a hyphen between the starting and ending values in the
number range. For example: to generate ten requisitions, type 1-10
in the ACCESSION: field.
The starting and ending Accession numbers that can be entered
must be numeric. Alphabetic characters (A through Z) can be used
when entering an individual Accession number, but not when
entering a range of Accession numbers.
Accession numbers cannot be changed once a Patient Requisition
is saved in the database.

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5 Press Enter.
6 Add the desired test(s). (Refer to steps 7 and 8 of section 6.2.1).
7 Press F10 to generate the multiple requisitions.

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6.2 Ordering Tests for Patient Sample Requisitions

6.2.1 Ordering Tests for a New Patient

1 Display the patient sample requisition form (see Section 6.1.1 on

page 104):

2 Type the date the sample was drawn and press Enter. The time field is
selected.

? Note: Enter the date the sample was drawn using the date format
(MM/DD/YY or DD/MM/YY) specified during system configuration.

3 Type the time the sample was drawn and press Enter. The BY: field is
selected.

? Note: Use the 24-hour time format (e.g. 21:30 for 9:30 pm) for
entering the time.

4 Type the initials of the technician who drew the sample and press Enter.
The ACCESSION: field is selected.

? Note: The system will automatically assign the Accession

number if specified during system configuration. The date and
time when the requisition was saved is automatically entered by
the system.

5 (If needed) Type the Accession number and press Enter. The
COMMENT: field is selected.

? Note: The Accession number can contain up to 16 numeric

characters. If the optional barcode scanner is enabled, the
Accession number must match the barcode label.

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6 Type a comment regarding the sample (if desired) and press Enter. The
TEST field is selected.

? Note: The comment can contain up to 39 alphanumeric

characters.

7 Type the mnemonic or abbreviation for the first test and press Enter. The
test is listed in the first TEST field, and the next TEST field is selected.
Or: press F2 to display a list of tests and test panels that are available.
Select the desired test (use the arrow keys) and press Enter:

? Note: If the test being ordered is a remote test, select the test and
then press F8. See page 113 for additional information.
Source requisitions for remote tests must be prepared first.

8 Repeat Step 7 to add additional tests to the Requisition.

9 To schedule the test(s) to be run ahead of routine samples, press F5.
STAT is displayed on the requisition:

10 Press F7 to load the sample. Or, press F10 to save the requisition and
load the sample at a later time.

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6.2.2 Adding One or More Tests to an Existing Requisition

1 Select Patient from the Requisitions menu. A list of patients that have
already been entered into the system is displayed:

? Note: To locate a name quickly, the Patient list can be sorted by

entering the first character(s) of the name in the name field.

2 Select the desired patient (using the arrow keys) and press Enter. A list of
requisitions for the patient is displayed:

3 Select the desired requisition (using the arrow keys) and press Enter. The
requisition is displayed:

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4 Press Insert. The next available TEST field is selected.

5 Type the mnemonic for the test and press Enter. The test is listed in the
TEST field, and the next TEST field is selected.
Or: Press F2 to display a list of tests and test panels that are available.
Select the desired test (use the arrow keys) and press Enter:

? Note: If the test being ordered is a remote test, select the test and
then press F8. See page 113 for additional information.
Source requisitions for remote tests must be prepared first.

6 Repeat Step 5 to add additional tests to the Requisition.

? Note: Press F5 to change the priority of the requisition.

7 Press F7 to choose a loading option for the sample. Or, press F10 to run
the test if the sample is already on the system.

? Note: The test will be run if the sample is already on the system
and has not been there for more than four hours.

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6.2.3 Ordering a Remote (Linking) Test

Certain tests are designated as remote tests during system configuration. A

remote test is run on a different sample from the same patient and, after the
test is run, the results are imported into the requisition containing the remote
test.
Examples of remote tests include tests requiring serial samples (for example,
glucose tolerance tests) and tests requiring different sample types (for
example, creatinine clearance).

? Note: The mnemonic for a remote test and for the corresponding source
test must be different. For example, GLU_1HR might be the mnemonic for
the one hour Glucose ordered as a remote test and GLU might be the
mnemonic for the actual Glucose test ordered (and run) on the pretreated
source sample.

The source requisition for a remote test must be prepared before the remote
test can be ordered (see Section 9.3.4 on page 201). For example, if a
Glucose Tolerance Test is ordered, the 1 Hour, 2 Hour, etc., should be
included in a requisition for the patient, and a serum sample should be run
under a second requisition so that they may be linked:

1 Create a requisition for the source test(s) (see Section 6.1 on page 103).
2 Order the source test(s).
3 Note the Accession number for the source test(s).
4 Press F10 to save the source test requisition, or press F7 to choose a
loading option for the sample(s).

After the source requisition is prepared, the GLU remote test can be included
on the requisition (see Section 6.2.2 on page 111):

1 Select the remote test (using the arrow keys) after it has been ordered.
2 Press F8. A prompt is displayed to enter the Accession number for the
source test.
3 Enter the Accession number for the source test (see Step 3 above).

? Note: Press F2 to display a list of existing Accession numbers from

which to select.

4 Press F10 to save the remote test link.

5 Continue with ordering the remaining remote tests.

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6.3 Modifying a Patient Requisition

6.3.1 Deleting a Test From a Requisition

? Note: A requisition must have at least one test remaining. An

active test cannot be deleted.

1 Select Patient from the Requisitions menu. A list of patients that have
already been entered into the system is displayed:

? Note: To locate a name quickly, the Patient list can be sorted by

entering the first character(s) of the name in the name field.

2 Select the desired patient (using the arrow keys) and press Enter. A list of
requisitions for the patient is displayed:

3 Select the desired requisition (using the arrow keys) and press Enter. The
requisition is displayed:

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4 Select the test (using the arrow keys) that is to be deleted.

5 Press Delete. A message to confirm the deletion is displayed.
6 Press Y. A prompt is displayed for entry of your initials and a comment.

7 Enter a comment.
8 Press F10. The test is deleted.
9 Press F10 again to save the requisition after deleting the test.

6.3.2 Changing Information in a Requisition

? Note: The First Name (if required), Last Name, Patient ID, and
Accession cannot be changed once a requisition is created and
accepted.

1 Select Patient from the Requisitions menu. A list of patients that have
already been entered into the system is displayed:

? Note: To locate a name quickly, the Patient list can be sorted by

entering the first character(s) of the name in the name field.

2 Select the desired patient (using the arrow keys) and press Enter. A list of
requisitions for the patient is displayed:

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3 Select the desired requisition (using the arrow keys) and press Enter. The
requisition is displayed:

4 Select the field (using the arrow keys) that is to be modified.

? Note: First Name (if required), Last Name, Patient ID, and
Accession cannot be modified.

5 Type the updated information and press Enter.

6 Press F10. The updated requisition is saved.

? Note: Modification of information in available fields requires

confirmation. In this case, a message to confirm the change is
displayed. To confirm the change press Y. A prompt is displayed.
Enter your initials and a comment and press F10. Press F10 again
to save the updated requisition.

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6.4 Creating a QC Requisition

QC requisitions are used to order tests on control materials.
A separate requisition is used for each control. Whenever a new sample is run from the
same lot number of a control, the existing requisition for that lot number is used for
ordering the tests to be run.

6.4.1 Selecting a Control Requisition

1 Select Quality Control from the Requisitions menu. A list of control

materials that have been entered into the system is displayed:

? Note: Information for new controls or new lot numbers is entered during
system configuration.

2 Select the desired control (using the arrow keys) and press Enter. The
requisition and the current test results for the control are displayed:

3 The displayed test results must be deleted before running a new QC test.
Press F6 to clear the entire requisition, or perform one of the procedures
in the following sections.

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6.4.2 Ordering a Rerun of All Tests

1 Press F5. A message to confirm deletion of all current test results is

displayed.
2 Press Y. The results are deleted.
3 Press F7 to load the sample. Or, if the sample is already on the system,
press F10 to run the test(s).

? Note: If the sample is not on the system, pressing F10 saves the
requisition so the sample can be loaded at a later time.

6.4.3 Ordering a Rerun of a Single Test

1 Select the test that is to be rerun.

2 Press Delete. A message to confirm the deletion is displayed.
3 Press Y. A prompt is displayed for entry of your initials and a comment.

4 Enter your initials and a comment.

5 Press F10. The test and the result are deleted.
6 Order the test as a new test (see Section 6.4.5 below).

6.4.4 Deleting all Current Tests

1 Press F6. A message to confirm the deletion is displayed.

2 Press Y. The tests and the results are deleted.
3 Order new tests (see Section 6.4.5). Or, press F10 to save the cleared
requisition.

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6.4.5 Ordering One or More New Tests

1 Press Insert. The next available TEST field is selected.

2 Type the mnemonic for the test and press Enter. The test is listed in the
TEST field and the next TEST field is selected.
Or: Press F2 to display a list of tests and test panels that are available.
Select the desired test (use the arrow keys) and press Enter:

3 Repeat Step 2 to add additional tests to the Requisition.

4 Press F7 to load the sample. Or, if the sample is already on the system,
press F10 to run the test(s).

? Note: If the sample is not on the system, pressing F10 saves the
requisition so the sample can be loaded at a later time.

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6.5 Creating a Calibration Requisition

A calibration requisition is used to order tests for a calibration. Unlike patient sample
requisitions and QC requisitions, a single calibration requisition is used for all calibrator
materials in a calibration run.

? Note: Tests that require calibration will be noted during the calibration status
check (see page 80). A test must be calibrated whenever a new lot number of
reagents is introduced or if certain software and/or hardware changes are
made.

6.5.1 Initiating a Calibrator Requisition

1 Select Calibration from the Requisitions menu. The Calibration

Requisition screen is displayed, with the first test field selected:

2 Type the mnemonic for the test to be calibrated and press Enter. The test
is listed in the first test field and the next test field is selected.
Or: Press F2 to display a list of tests and test panels that are available.
Select the desired test (use the arrow keys) and press Enter:

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3 Repeat Step 2 to add additional tests to the requisition. As each test

needing calibration is added to the requisition, the calibrator(s) that are
required are automatically listed in the Calibrators section:

4 When all tests requiring calibration have been entered, press F10. The
loadlist for the calibration is displayed:

? Note: If a message is displayed indicating that the required

calibrators are already on board, press F10 again to initiate the
run.

5 Type a segment number in the SEGMENT field and press Enter. The next
available cup position is selected.

6 The calibrators may be run alone, or additional samples can be added to

the loadlist.

? Note: See page 131 for instructions.

7 Following the loadlist, place the calibrator(s) and any additional samples
into the designated positions on the cup segment.

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8 Press F7 to place the segment.

? Note: See page 131 for instructions.

9 Press F10 to begin processing.

? Note: When the calibrator samples are run, a report of the results
is printed (if enabled in Setup). If calibration fails for a test, that test
is put on hold and no further samples will be run for the test until a
calibration is successfully completed for the test.

6.5.2 Initiating a Correction Requisition

Corrections are performed based on the frequency requirement of the individual test. In
a correction run, the curve corrector is used to adjust the stored calibration curve. For
more information on modifying calculation method parameters, refer to Section 9.2.3 on
page 194).
1 Select Correction from the Requisitions menu. The Correction Requisition
screen is displayed, with the first test to be corrected selected:

2 Type the mnemonic for the test to be corrected and press Enter. The test
is listed in the first test field and the next test field is selected.
Or: Press F2 to display a list of tests and test panels that are available.
Select the desired test (use the arrow keys) and press Enter.
3 Repeat Step 2 to add additional tests to the requisition. As each test
needing correction is added to the requisition, the corrector(s) that are
required are automatically listed in the Correctors section.
4 Press F10 to display the Corrector Requisition loadlist.

? Note: Refer to the Calibration Requisition loadlist on page 121. If

the required correctors are already on board, press F10 again to
initiate the run.

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5 Type a segment number in the SEGMENT: field and press Enter. The
next available cup position is selected.
6 The correctors may be run alone, or additional samples can be added to
the loadlist.

? Note: See page 131 for instructions.

7 Following the loadlist, place the corrector(s) and any additional samples
into the designated positions on the cup segment.

8 Press F7 to place the segment.

? Note: See page 131 for instructions.

9 Press F10 to begin processing.

? Note: When the correction samples are run, a report of the results
is printed (if enabled in Setup). If a correction fails, results will be
reported using the stored calibration curve until the correction
passes.

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7 Running Tests

Samples can be loaded and run individually, or a group of samples can be loaded and
run as a batch. Samples must be run within four hours after they have been loaded.

? Note: A requisition must be created before a sample can be loaded and run.

7.1 Running a Single Sample

An individual sample can be loaded onto the system directly from an open or closed tube
and run. For systems equipped with an optional barcode reader, a tube with a barcode
label can be loaded and run at any time. A tube without a barcode label must be loaded
and run while the requisition for that sample is displayed.

? Note: A clean well segment must be on board to run sample tubes.

Alternately, an aliquot of a single sample can be transferred from the tube into a sample
cup. The filled sample cup can then be loaded and run while the requisition for that
sample is displayed.

7.1.1 Running a Tube with a Barcode Label

? Note: This is applicable only for systems equipped with an optional barcode
reader.

1 Place the tube in the STEP. A sample will be aspirated from the tube and
dispensed into a well segment. The ordered tests will then be run on the
sample.

? Note: A requisition must exist for the tube before it can be run.
Be sure that the barcode label is facing towards the left when
inserting the tube into the STEP.

2 Remove the tube from the STEP when it is returned.

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7.1.2 Running a Tube without a Barcode Label

1 Display the requisition for the sample.

2 Press F7. The screen displays:

3 Place the tube in the STEP. A sample will be aspirated from the tube and
dispensed into a well segment for processing. The ordered tests will then
be run on the sample.
4 Remove the tube from the STEP when it is returned.

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7.1.3 Running an Individual Sample Cup

1 Display the requisition for the sample.

2 Press F7. The screen displays:

3 Press F7 again. The messages Pausing the Instrument… and

Positioning the sample ring… are briefly displayed before instructions
for loading the cup are displayed:

4 When the access door unlocks, the segment access cover can be opened.

? Important: Always wait for the access door to be unlocked

before trying to open the segment access cover. Never force the
access door open.

5 Transfer an aliquot of the sample to a sample cup.

6 Place the filled sample cup in the cup segment position designated by the
arrow (Figure 34).
7 Close the access cover.
8 Press F10. The ordered tests will be run on the sample.

Figure 34. Designated Sample Cup Segment Position

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7.1.4 Refilling a Short Sample Cup

A sample cup that has run short may be replenished with additional sample.
1 Press Fn and F2 to display the Access menu:

2 Select Cup. The Cup menu is displayed:

3 Select Fill. The Fill Cup screen is displayed listing all segments on the
sample ring.
4 Select the cup segment containing the short sample (use the arrow keys).
5 Press Enter. Information for the segment is displayed.
6 Select the short cup (use the arrow keys).
7 Press Enter. The tray is rotated to the correct position. Then, the message
Fill the cup in the instrument… is displayed.
8 Open the segment access cover and add sample to the cup indicated by
the arrow.
9 Close the cover and press F10.
10 Press Esc until the Main menu is displayed.

7.1.5 Replacing an Expired Sample Cup

An expired sample cup that has tests pending may be replaced with a fresh cup.
1 Press Fn and F2 to display the Access menu.
2 Select Cup. The Cup menu is displayed.

3 Select Change. The Change Cup screen is displayed listing all segments
on the sample ring.

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4 Select the cup segment containing the expired sample (use the arrow
keys).
5 Press Enter. Information for the segment is displayed.
6 Select the expired cup (use the arrow keys).
7 Press Enter. The tray is rotated to the correct position.
Then, the message Change the cup in the instrument… is displayed.
8 Open the segment access cover, remove the expired sample cup from the
position indicated by the arrow and replace it with a fresh sample cup.
9 Close the cover and press F10.
10 Press Esc until the Main menu is displayed.

7.1.6 Removing an Inactive Sample Cup

1 Press Fn and F2 to display the Access menu.
2 Select Cup. The Cup menu is displayed.

3 Select Remove. The Remove Cup screen is displayed listing all segments
on the sample ring.
4 Select the cup segment containing the inactive sample (use the arrow
keys).
5 Press Enter. Information for the segment is displayed.
6 Select the inactive cup (use the arrow keys).
7 Press Enter. The tray is rotated to the correct position.
Then, the message Remove the cup from the instrument… is displayed.
8 Open the segment access cover and remove the inactive cup from the
position indicated by the arrow.
9 Close the cover and press F10.
10 Press Esc until the Main menu is displayed.

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7.1.7 Manual Rerun of Tests

In order to manually rerun a test on a patient requisition, the existing test must first be
deleted.
1 Display the patient requisition containing the test to be rerun.
2 Select the test to be rerun (use the arrow keys).
3 Press Delete. A message to confirm the deletion is displayed.
4 Press Y. A prompt is displayed for entry of your initials and a comment.
5 Enter your initials and a comment.
6 Press F10. The test is deleted.
7 Press Insert. The TEST field is selected.
8 Type the mnemonic for the test and press Enter. The test is listed in the
TEST field.
Or: Press F2 to display a list of tests and test panels that are available.
Select the desired test (use the arrow keys) and press Enter:

9 Press F10 again to save the edited requisition and begin processing if the
sample is already on the system.

? Note: The test will be run if the sample is already on the system
and has not been there for more than allowable time period.

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7.2 Running a Batch of Samples

Samples can be loaded and run as a batch. A list is created to process up to 15 sample
cups together. Multiple sample tubes can be loaded into the instrument by using the
Rapid Tube Input (RTI) mode.

7.2.1 Running a Batch of Sample Cups

When loading a batch of sample cups, an aliquot of each sample is poured into a sample
cup. Each sample cup is then placed in the designated numbered cup position on the
cup segment. After all of the sample cups have been filled and placed in their designated
positions, the filled cup segment is loaded onto the system and the tests are run.

? Note: A cup and segment placement list is created prior to loading a batch
of samples. The list shows each sample that is to be run and the numbered
position where it must be placed on the cup segment. The list can be printed.

1 Select Cup/Segment Placement from the Main menu. A list of cup

segments that are currently saved in the system is displayed:

? Note: If no segments exist, a blank list is displayed.

2 Select a segment number from the list to display the corresponding loadlist
(or press Insert to add a new segment).

? Note: If a new loadlist is displayed, type the segment number (1 to

99) and press Enter. The first available cup position is highlighted.

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3 Press F5 (Build Segment) to automatically fill the loadlist with pending

requisitions.
Note: Alternately, type the patient’s name (or press F2 to select
? from the list) in the available cup position(s) to fill the loadlist.

4 Press F8 to print the loadlist.

Note: To delete a name from the loadlist, select the name by
? pressing the up or down arrow key and then press Delete.

5 Transfer the aliquot of sample to the cup and place the sample cup on the
designated cup position shown on the loadlist.
6 Press F7 to place the cup segment on the system. The messages
Pausing the Instrument… and Positioning the sample ring… are
briefly displayed before instructions for loading the cup segment are
displayed:

? Note: Press F10 instead of F7 to save the loadlist for processing

later.

7 When the access door unlocks, the segment access cover can be opened.

? Important: Always wait for the access door to be unlocked

before trying to open the segment access cover. Never force the
access door open.

8 Place the cup segment on the posts.

9 Close the access cover.
10 Press F10 to begin the run.

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7.2.2 Running a Batch of Sample Tubes

The Rapid Tube Input (RTI) mode allows loading of multiple sample tubes into the
instrument without initiating processing. Enabling the RTI mode dedicates the probe to
aspirating samples from primary tubes placed into the STEP and dispensing these
samples into seglet wells. The instrument begins processing when the RTI mode is
disabled.

? Note: The RTI mode can be enabled from any screen.

1 Press the Ctrl and F6 keys simultaneously to enable the RTI mode.

? Note: RTI appears at the top center of the screen.

2 Place the first tube in the STEP following the instructions in section 7.1.2
on page 126.

? Note: For systems equipped with an optional barcode reader,

place barcoded tubes in the STEP, following the instructions in
section 7.1.1 on page 125.

3 Repeat step 2 for each additional tube.

4 When all tubes are loaded, press the Ctrl and F6 keys simultaneously to
disable the RTI mode and begin processing.

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7.3 Results
Test results can be printed automatically when all tests for a requisition are completed,
or they can be printed on demand by the operator.

7.3.1 Patient Results

The patient results report contains demographic information for the patient, results for
the tests ordered on that requisition, normal ranges for those tests (if they are defined)
and a graphical representation of where the test results fall within the normal range:

PATIENT REQUISITION REPORT

LAST NAME: JONES DOB: 04/05/50 DOCTOR: NELSON

FIRST NAME: PETER AGE: 54 LOCATION: 221
PATIENT ID: 112-32-4567 SEX: M COMMENT:

D/T DRAWN: 08/13/04 13:30 BY: KMO D/T ENTERED: 08/13/04 14:39
ACCESSION: 719721 COMMENT: FASTING

TEST RESULT NORMAL RANGE LL[ NORMAL ]HH UNITS

_______ ________ __________________ _____________________ _______
ALB 4.5 3.5 - 5.0 [ ? ] mg/dL

CREAT 0.9 0.7 - 1.3 [ ? ] mg/dL

BUN 13. 7. - 18. [ ? ] mg/dL
GLU 105. 70. - 105. [ ? ] mg/dL
TP 7.3 6.4 - 8.3 [ ? ] mg/dL

T. BILI 0.6 0.0 - 1.0 [ ? ] mg/dL

AST 29. 7. - 31. [ ? ] U/L
LDH 130. 63. - 155. [ ? ] U/L

APPROVED BY:

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7.3.2 Quality Control Results

A quality control report contains identifying information for the control material, test
results, acceptable limits for those tests and a graphical representation of where the test
results fall within the limits. If a value is out of the control range, the value is identified
and space is provided for noting corrective action.

QUALITY CONTROL REQUISITION REPORT

CONTROL: QC1 LOT: 2807

D/T: 08/13/04
09:30

TEST RESULT ACCEPTABLE RANGE ACCEPTABLE UNITS

_______ ________ __________________ _____________________ _______
NA 140. 136. - 145. [ ? ] mmol/L
K 4.1 3.8 - 4.7 [ ? ] mmol/L
CL 108. 99. - 115. [ ? ] mmol/L
CHOL 126. 113. - 140. [ ? ] mg/dL

TBILI 1.0 0.7 - 1.3 [ ? ] mg/dL

TRIG 70. 58. - 76. [ ? ] mg/dL

ALP 107. 87. - 129. [ ? ] U/L

AMY 52. 43. - 64. [ ? ] U/L

LDH 126. 104. - 146. [ ? ] U/L
CO2 18.1 12.2 - 20.0 [ ? ] mmol/L

MG 2.4 1.8 - 2.8 [ ? ] mg/dL

DBILI 0.26 0.00 - 0.60 [ ? ] mg/dL

CORRECTIVE ACTION:

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7.3.3 Calibration Report

A calibration report lists the data from the calibration runs for all tests on that requisition.

CALIBRATION REPORT

TEST: ALB STATE: CAL PASSED CAL D/T: 08/13/04 11:14

(- - - - - - - - - - - - - - - -RESPONSE- - - - - - - - - - - - - - - -) CONCENTRATION

CALIBRATOR 1 2 3 AVERAGE SET PT CALC

____________ _________ _________ __________ __________ ______ _____
_ _
GEMCAL 2069 0.2951 0.2947 0.2958 0.2952 3.7 3.7

CALIBRATOR CAL FACTOR CAL FACTOR RANGE

____________ _____________
_____________________
GEMCAL 2069 12.5335 7.0000 - 15.0000

TEST: GLU STATE: CAL PASSED CAL D/T: 08/13/04 11:35

(- - - - - - - - - - - - - - - -RESPONSE- - - - - - - - - - - - - - - -) CONCENTRATION

CALIBRATOR 1 2 3 AVERAGE SET PT CALC

____________ _________ _________ __________ __________ ______ _____
_ _
GEMCAL 2069 0.3290 0.3290 0.3291 0.3290 217. 217.

CALIBRATOR CAL FACTOR CAL FACTOR RANGE

____________ _____________
_____________________
GEMCAL 2069 659.5054 580.0000 – 678.0000

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7.3.4 Verifying Results

Results are automatically verified by the system as they are obtained. If a result is
outside the specified panic limits or if an error is detected during results calculation, the
VERIFY message is displayed (page 149) and the results must be manually verified
before the test is noted as completed.

1 Press F9 when the VERIFY message is displayed. The item number, the
reason for verification, the Accession number of the requisition, the test
name and the action to be taken are displayed.
2 Press Esc until the Main menu is displayed.
3 Select Requisition and then Patient (or Control).
4 Press F6.
5 Select the patient (or Control) requisition to be verified.
6 Examine the results of the test. Depending on the results, either delete the
test, delete the result, or press F10 to accept the result.

? Note: If the result is deleted, the test will be rerun. If the test is
deleted, it will not be rerun unless it is reordered.

Tests with errors cannot be accepted.

7 If the results are accepted, a message is displayed to confirm the

verification.
8 Press Y. The result is accepted.

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7.3.5 Entering Off-Line Results

Results from another instrument or other data can be entered as an off-line result, so
they can be included on the patient requisition and report.

? Note: Refer to Section 9.3.1 on page 199 for the procedure to set up an
off-line test.

1 Select the desired patient requisition.

2 Select the off-line test (use the arrow keys).
3 Press Enter. The RESULT field is selected.
4 Enter the result.
5 Press F10.
6 A prompt is displayed for entry of your initials and a comment.
7 Enter a comment.
8 Press F10.

7.3.6 Entering Calculation Test Values

Calculation test values, such as height or weight are used in derived test equations.

? Note: Refer to Section 9.3.3 on page 201 for the procedure to set up a
calculation test.
1 Select the desired patient requisition.
2 Select the calculation test (use the arrow keys).
3 Press Enter. The RESULT field is selected.
4 Enter a value for each field.
5 Press F10.
6 A prompt is displayed for entry of your initials and a comment.
7 Enter a comment.
8 Press F10.

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7.3.7 Editing Test Results

Results can be edited.

1 Select the patient requisition for which results are to be edited.

2 Select the test to be edited (use the arrow keys),
3 Press F6. The RESULT field is selected.
4 Press F4.
5 Enter the new result.
6 A prompt is displayed for entry of your initials and a comment.
7 Enter a comment.
8 Press F10. The test result is updated. The new result is reported on the
requisition.
9 Press F10 to accept the edited requisition.

? Note: A record of the change, including the original result and

the new result, is stored in the Audit Journal.

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7.4 Quality Assurance

Quality assurance protocols provide additional assurances that the system is functioning
properly and that the results of each test are correct.
A total quality assurance program must incorporate various aspects of proper laboratory
technique in order to produce consistently accurate results. The program should include
the following:
?? Proper sample handling procedures.
?? Use of the reagents and consumables that are recommended for the system by
the manufacturer.
?? Following recommended preventive maintenance procedures.
?? Daily use of normal and abnormal controls to verify proper system performance.
?? Following recommended procedures when a test appears to be out of control.
?? Proper identification, reporting, and archiving of test results.
?? Training and continuing education for laboratory personnel.

7.4.1 Use of Quality Control Material

Two levels of controls should be run every day that a test is performed before reporting
patient results. Alfa Wassermann Diagnostic Technologies, LLC recommends the use of
AWDT Controls that are prepared and handled in accordance with the instructions on
the package inserts included with the products.
Acceptable limits for controls are listed on the package inserts for the products. Values
falling outside of acceptable limits are considered out of control and require corrective
action.
Information for controls is entered and QC options are selected during system
configuration. The following QC options are available:

Option Purpose
Quality Control Checks Aids in identifying trends. The system will flag results if
consecutive control values exceed a designated standard
deviation limit.

Reports Prints QC Requisition reports automatically, transmits QC

results automatically to a LIMS, and selects a moving
average for cumulative QC statistics and Levey-Jennings
plots.

QC Reminder Displays a reminder at a specified time of day to run

controls.

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7.4.2 Corrective Action

Corrective action must be taken and documented whenever the results on one or more
of the controls are outside of the acceptable range of values. The corrective actions that
should be taken are summarized below:

Action Purpose
Repeat Same Control(s) Do not assay or report patient results until the same
control(s) are repeated. If results from the repeated tests are
within the acceptable range of values, patient results may be
reported.

Test Freshly-Prepared If results from the tests on freshly-prepared controls are

Controls within the acceptable range of values, patient results may be
reported.

Re-calibrate If control results from the re-calibrated tests are within the
(where applicable) acceptable range of values, repeat the tests with patient
specimens.

Prepare Fresh Reagents If control results from the tests using freshly prepared
reagents are within the acceptable range of values, repeat
the tests using patient specimens.

? Note: Contact Alfa Wassermann Diagnostic Technologies, LLC Technical

Service if all of the above corrective actions fail.

7.4.3 Precision Data

The instrument precision, accuracy and linearity (up to three levels) for a test can be
generated by selecting options on the Diagnostics menu.

1 Select Diagnostics from the Main menu. The Diagnostics menu is

displayed.
2 Select Performance, then Chemistry. The Chemistry menu is displayed:

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3 Select Precision. The Precision Parameters screen is displayed:

4 With the TEST: field selected, type the test mnemonic or press F2 and
select the desired test from the choice list. The NUMBER OF LEVELS:
field is selected.
5 Type the number of levels to be run (1 to 3) and press Enter. The
SAMPLES/LEVEL: field is selected.
6 Type the number of sample cups to be run for each level (1 to 60) and
press Enter. The RUNS/SAMPLE: field is selected.
7 Type the number of runs or replicates per sample (1 to 48).

? Note: This represents the number of times the assay is to be

repeated on each sample cup.

8 Press Enter. The 1ST SEGMENT: field is selected.

9 Type a segment number and press Enter. If needed, the 2ND SEGMENT:
field is selected.

? Note: The system automatically determines how many segments

are needed based on the number of samples and levels. N/A is
displayed next to any segment that is not needed.

If no additional segments are needed, the Assay Status: field is

selected.

10 Type a segment number for additional segments (if needed).

? Note: Up to four segments may be numbered.

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11 Press F2 at the ASSAY STATUS: field and select Assayed or

Unassayed.

12 If Assayed was selected, type a concentration and press Enter for each
level. If Unassayed was selected, proceed to the next step.

? Note: The number of replicates per sample times the number of

samples cannot exceed 120.
All tests that require a calibrator must be calibrated before using
this diagnostic.

13 Press F10 when all parameters have been entered. The Precision Loadlist
screen is displayed.

14 Following the loadlist, place the samples into the designated positions of
empty cup segments.
15 Press F10, then place the first segment into the instrument when
prompted.
16 Press F10.

? Note: If there are no additional segments to place, the run

begins.
If additional segments are to be placed, follow screen
instructions. Press F10 after the last segment is placed to begin
the run.

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At the completion of the run, the statistics are calculated and a report is generated with
the following information:
?? Sample identification by segment number and cup position.
?? Sample concentration (if specified).
?? Mean, SD and % CV for samples with more than one replicate or run.
?? Grand Mean, SD and % CV on results of all samples within one level (with the
same concentration). If more than one replicate or run was performed on each
sample, the average of the results for each sample is used in the calculation.
?? Accuracy statistics reported as the percentage of the expected result
(concentration must be a value other than zero).
?? Linearity data calculated as slope, intercept, standard error and correlation
coefficient (if the concentrations were specified for more than one level).

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7.4.4 Correlation Data

The correlation function measures instrument correlation statistics for a group of

samples for a specific test. It can also be used to generate linearity data when more than
three levels are required.
In order to use the correlation function to compare methods, first obtain the comparison
data to which the ACE Alera System is to be correlated. When the results from the
comparison method or instrument have been generated, the concentrations of the
samples can be entered into the correlation loadlists and the correlation study can be
performed.

1 Select Diagnostics from the Main menu. The Diagnostics menu is

displayed.
2 Select Performance, then Chemistry. The Chemistry menu is displayed:

3 Select Correlation. The Correlation Parameters screen is displayed.

4 With the TEST: field selected, press F2 and select the desired test. The
NUMBER OF SAMPLES: field is selected.
5 Type the number of samples to be run (1 to 60) and press Enter. The
RUNS/SAMPLE: field is selected.
6 Type the number of runs or replicates per sample (1 to 48).

? Note: This represents the number of times the assay is to be

repeated on each sample cup.

7 Press Enter. The 1ST SEGMENT: field is selected.

8 Type a segment number and press Enter. If needed, the 2ND SEGMENT:
field is selected.

? Note: The system automatically determines how many segments

are needed based on the number of samples. N/A is displayed
next to any segment that is not needed.

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9 Type a segment number for additional segments if needed.

? Note: Up to four segments may be numbered.

The number of replicates per sample times the number of
samples cannot exceed 120.
All tests that require a calibrator must be calibrated before using
this diagnostic.

10 Press F10 when all parameters have been entered. The Correlation
Loadlist screen is displayed.

11 Enter the sample concentration for each cup position.

12 Following the loadlist, place the samples into the designated positions of
empty cup segments.
13 Press F10, then place the first segment into the instrument when
prompted.
14 Press F10.

? Note: If there are no additional segments to place, the run

begins.
If additional segments are to be placed, follow screen
instructions. Press F10 after the last segment is placed to begin
the run.

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At the completion of the run, the statistics are calculated and a report is generated with
the following information:
?? Mean, SD and %CV for samples with more than one replicate per run.
?? Accuracy statistics reported as a percentage of the expected value for each cup
concentration. If more than one replicate or run per sample was performed, the
average of the results is used for each sample.
?? Linearity data calculated as slope, intercept, standard error and correlation
coefficient if different concentrations were specified for the cups. If more than one
replicate or run was performed per sample, the average of the results is used for
each sample.

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7.5 Status Indicators During the Run

Certain events or conditions may occur during a run. If this happens, one or more status
indicators are displayed at the bottom of the screen (Figure 35).
A status indicator may simply provide routine information (that the hopper can be
accessed, for example), or it may alert the operator that action is required (if a result
requires manual verification, for example).

Status Indicators

Figure 35. Status Indicators

Status Indicators that displayed and the required operator action are summarized below.

Message Reason Action Required

ATTENTION An event has occurred that Refer to Chapter 2 of the

requires operator notice or Troubleshooting Manual.
attention. Press F9 to display the attention
log and cancel the alarm.

HOPPER The hopper can be accessed. Refer to Section 5.3.1 on page 86

ON-HOLD One or more tests cannot be Refer to Section 5.2.4 on page 81

completed.

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Message Reason Action Required

VERIFY A result requires manual Refer to Section 7.3.4 on
verification page 137

STAT A STAT requisition is No action is required.

incomplete. This message is displayed
whenever a STAT test is
ordered, and it remains until
results on the STAT sample are
printed.

PAUSED The system has been halted Complete the activity requiring
by the operator to allow access and close the access
instrument access. door. Press Esc until the
indicator is no longer displayed.

TEMPERATURE The cuvettes in the reaction No action is required.

wheel are not at the correct The system will begin operation
temperature. This usually automatically once the correct
occurs upon exit from a temperature is reached.
diagnostics or utilities routine.

7.6 Stopping the Run

If necessary, the run can be stopped at any time.

1 Select Initialize from the Diagnostics menu. A prompt to confirm halting

the run is displayed.
2 Press Y. The run is halted and the instrument returns to Standby status.

? Note: Alternatively, press Fn and F2 and remove all active

samples.

WARNING: The ACE Alera System can be immediately stopped at any

time by turning OFF the UPS power switch.

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7.7 Daily Shutdown

It is recommended that the following procedures be performed when daily processing is
complete.

7.7.1 Check Fluid Levels

Refer to section 5.5 on page 95.

7.7.2 Remove Used Sample Cups and Seglets

Biohazard: Federal, state and local laws and regulations require that
hazardous waste be disposed of in a specific manner. Waste material from
the ACE Alera System that may be classified as biohazardous includes used
sample cups and seglets. It is important that steps be taken to dispose of
these materials in accordance with the prevailing regulations in your location.

1 Press Fn and F2 to display the Access menu.

2 Select Segments, Remove.
3 Select a cup segment with a status of INACTIVE. The tray is rotated to the
correct position.
4 Open the segment access cover when prompted.
5 Remove the segment and discard the sample cups in accordance with
local regulations.
6 Repeat for additional cup segments.

? Note: Repeat this procedure for well segments with a status of

DONE. Well segments with a status of USABLE may be left in the
sample ring.

7.7.3 Backup System

It is recommended that a system backup be performed on a daily basis. Refer to section

8.5.1 on page 169 for instructions.

7.8 Powering Off the System

At the main menu, select Exit to DOS and press Enter. Power off the system from the
UPS (see Figure 2).

WARNING: The ACE Alera System can be immediately stopped at any

time by turning OFF the UPS power switch.

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8 Data Management

A wide variety of reports are available on the system. These may be viewed on and
printed from the Workstation or can be transmitted to a laboratory information
management system (LIMS).
System data should be backed up on a regular basis and stored in a safe location. The
system data can then be restored if needed.
Finally, patient requisitions must be periodically deleted from the system in order to allow
additional free space to be available on the hard drive for new data. The patient
requisitions can be archived before deletion, if desired.

8.1 Types of Reports

8.1.1 Patient Reports

Available patient reports are summarized below:

Report Description
Single Requisition Complete information for a specified patient requisition is
included. The information includes facility identification,
patient demographics, requisition date and time, Accession
number, comment field, test mnemonics, test results, result
flags, normal ranges (if defined), graphical display of the
result with respect to the normal range, and the reporting
units for the test.

Cumulative Requisition Summarized information for all requisitions for a specified

patient is printed, in the order of date and time of each
requisition. The report contains the same information as the
single requisition with the exception of graphical display of
the result with respect to the normal range.

Merged Summarized information for selected tests for requisitions

from a specified date range. The report can be printed or
exported to a file on drive A.

Archived Requisition Complete information for a specified patient requisition is

(from Archive Disk) printed. The information includes facility identification,
patient demographics, requisition date and time, Accession
number, comment field, test mnemonics, test results, result
flags, normal ranges (if defined), graphical display of the
result with respect to the normal range, and the reporting
units for the test.

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8.1.2 QC Reports

Available QC reports are summarized below:

Report Description
QC Requisition Complete information for a specified QC requisition is
included. The information includes facility identification,
control name and lot number, requisition date and time, test
mnemonic, test results, result flags, low and high acceptable
limits, graphical display of the result with respect to the
acceptable limits and the reporting units for the test. A
Corrective Action field is provided in the event of a failure.

Levey-Jennings Plots Cumulative statistics (up to 250 data points) for each analyte
are plotted. The report flags any values that violate QC
checking rules. Monthly reports can be obtained by
specifying the corresponding range of dates for the report.

Cumulative Statistics Cumulative statistics for each analyte are tabulated. This
report will display the mean and SD values entered from the
package insert for a single lot number of control until more
than 20 data points have been obtained if moving average
has been enabled.

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8.1.3 Other Reports

Other available system reports are summarized below:

Report Description
Backlog Reports All incomplete tests that are not active are listed by
requisition. The report can be customized using filters to
specify on-line and off-line tests and a date range.

Journal Reports System error messages and operator audit trail entries are
included. Journal reports can be prepared for routine events
such as result edits, maintenance procedures, errors
requiring operator intervention, and service procedures.

Calibration Data All data, including absorbance measurements, from the

most recent calibration curve and correction run (if
appropriate) by test. An abbreviated report may also be
configured to print after each calibration or correction run.

Raw Data Absorbance measurements used to calculate results for a

patient or control by test. (This report is normally ordered
under the direction of a Technical Service representative to
troubleshoot a problem).

Test Parameters Prints the setup program parameters for a particular test.

Test Counts The number of tests run, since the counter was last reset,
for each on-line test.

Performance Reports Reprints the report of the most recent performance

diagnostic that was run.

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8.2 Preparing a Patient Report

8.2.1 Single Requisition

1 Select Patient from the Reports menu. The Patient Reports menu is
displayed.
2 Select Single. The list of current patients is displayed.
3 Use the arrow keys to select the desired patient by name.
4 Press Enter. The Patient Accession list is displayed.
5 Use the arrow keys to select the desired Accession number and press
Enter. The report is generated and displayed.
6 Press F8 to obtain a hard copy of the report.

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8.2.2 Cumulative Report

1 Select Patient from the Reports menu. The Patient Reports menu is
displayed.
2 Select Cumulative. A list of patients with at least one completed
requisition is displayed.
3 Use the arrow keys to select the desired patient by name.
4 Press Enter. A summary of all the requisitions in the database for the
patient is generated and displayed.

? Note: The format of the report facilitates the detection of trends

in any of the test results.

5 Press F8 to obtain a hard copy of the report.

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8.2.3 Merged Report

A merged requisition report displays all patient requisitions in the system for the selected
tests within a selected date range.

1 Select Patient from the Reports menu. The Patient Reports menu is
displayed.
2 Select Merged. A screen is displayed for entering the date and time range
for the report.

3 Type the beginning date, beginning time, ending date, and ending time for
the report.

? Note: Use the up and down arrow keys to move from one field to
the other. Use the left and right arrow keys to move within a field.

4 Press F10 when all information is entered. The message Preparing test
choice list is displayed on the screen, then the choice list is displayed.
5 Select the desired test (use the arrow keys).
6 Press Enter. A check mark is displayed next to the test.
7 Repeat steps 5 and 6 for all desired tests.

? Note: Any number and combination of tests can be selected.

Press F5 to select all tests in the choice list.

To deselect a checked test, highlight the test and press Enter.

8 When all desired tests have been selected, press F10 to generate and
display the report.

? Note: A percent complete message is displayed while the report

is prepared.

9 Use the arrow keys or the page up and page down keys to view all
sections of the report.

? Note: The report includes complete and incomplete requisitions.

An incomplete result is reported as a blank space. Unverified
results are also included in the report and are not distinguished
from verified results.

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10 Press F8 to obtain a hard copy of the report, OR proceed to step 11 to

export the data.

? Note: Press Esc until the Main menu is displayed.

11 Press F5 to export the data to a file on drive A.

12 Insert a formatted disk into drive A and follow the screen prompts.
13 When complete, press Esc until the Main menu is displayed.

8.2.4 Archived

Patient data that is archived on a 3.5 inch disk can be viewed and printed but not edited.
Refer to section 8.6.4 on page 174 for instructions on viewing and printing an archived
patient requisition.

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8.2.5 Review of Patient Reports

If the system has been configured to require review of patient reports (refer to section
9.10.9 on page 221), each patient requisition must be reviewed before a report can be
printed.

1 Select Patient from the Reports menu. The Patient Reports menu is
displayed.
2 Select Review. A list of patients with requisitions ready for review is
displayed.

? Note: Press F7 to accept and print all requisitions on the list

without further review.

3 Use the arrow keys to select the desired patient by name.

4 Press Enter. The Patient Accession list is displayed.
5 Use the arrow keys to select the desired Accession number and press
Enter. The report is generated and displayed.
6 Press F10 to approve and print the requisition.

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8.3 Preparing a QC Report

8.3.1 Requisition

? Note: Only the most current requisition for a control can be viewed and
printed.

1 Select Quality control from the Reports menu. The QC Reports menu is
displayed.
2 Select Requisition. The Controls list is displayed.
3 Use the arrow keys to select the desired control and press Enter. The last
QC requisition report is generated and displayed.
4 Press F8 to obtain a hard copy of the QC Requisition report.

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8.3.2 Monthly Levey-Jennings Plots

Levey-Jennings Plots are available for the last 250 values for each test run on each
control. Any values that are in violation of any of the QC checking rules are flagged. The
format in which Levey-Jennings plots are displayed can be selected, and a filter is
provided so that plots for a selected month can be reviewed and charted.

1 Select Quality control from the Reports menu. The QC Reports menu is
displayed.
2 Select Plots. The Test list is displayed.

3 Select a test Press F7. A filter list of months is displayed.

4 Select the desired month (use the arrow keys) and press Enter. Levey-
Jennings plots for each test during the selected month are created and
can be printed.

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8.3.3 Individual Levey-Jennings Plots

1 Select Quality Control from the Reports menu. The QC Reports menu is
displayed.
2 Select Plots. The Test list is displayed.

3 Select the desired test from the list (use the arrow keys)
4 Press Enter. Levey-Jennings plots for the selected test are generated and
data points for the first control are displayed.

? Note: Press F5 to display data points for the next control on the
same test.

5 Press F8 to obtain a hard copy of the plot(s).

8.3.4 Including More Information in Individual Levey-Jennings Plots

Individual Levey-Jennings plots can be displayed in three formats:
?? Plotted data points, scaled according to the mean and standard deviation (SD)
for the control.
?? Plotted data points, scaled according to the mean and standard deviation (SD)
for the control, plus numeric results for the control.
?? Plotted data points, scaled according to the mean and standard deviation (SD)
for the control, plus numeric results, plus cumulative and filtered statistics for the
control.

1 Select Quality control from the Reports menu. The QC Reports menu is
displayed.
2 Select Plots. The Test list is displayed.

3 Select the desired test from the list (use the arrow keys).
4 Press Enter. Levey-Jennings plots for the selected test are generated,
and the data points for the first control are displayed.
5 To add numeric results to the plotted results, press F6. To add cumulative
and filtered statistics for the control to the plotted results and numeric
results, press F6 again.
6 To filter the data by month, press F7, select the desired month, and press
F10. The data is filtered.
7 Press F8 to print a copy of the plot(s).

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8.3.5 QC Statistics

The cumulative statistics report lists the estimated or established mean and standard
deviation (SD) values, the number of data points and the actual mean, actual SD and
actual coefficient of variation (% CV) of all the control results for each test run on each
control.
1 Select Quality control from the Reports menu. The QC Reports menu is
displayed.
2 Select Statistics. The Control Cumulative Statistics report is generated
and displayed.
3 Press F8 to obtain a hard copy of the report.

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8.4 Preparing Other Reports

8.4.1 Backlog Report

The Backlog report lists all incomplete inactive tests. This information is displayed for
requisitions that have at least one on-line or off-line test without a result.

? Note: The information displayed can be filtered to exclude the most recent
requisitions or to include only on-line or off-line tests on the report.

1 Select Backlog from the Reports menu. A filter box is displayed.

2 Enter the date, time and type of test to review.

3 (If needed) Press F2 to display a list of test types. Select the desired test
type and press Enter.

? Note: ALL is selected by default.

4 Press F10. The report is generated and displayed:

5 Press F8 to print the report.

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8.4.2 Test Counts Report

A Test Count report can be prepared, listing the number of tests run since the test
counter was last reset.

? Note: This report is available for on-line photometric tests.

1 Select Test Counts from the Reports menu. The report is generated and
displayed:

2 Press F8 to print the report.

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8.4.3 Calibration Report

A Calibration report displays the optical data, by test, for the last calibration or correction
curve run.

1 Select Calibration from the Reports menu. A list of tests with stored
calibration curves is displayed.
2 Select the test to be reviewed (use the arrow keys).
3 Press Enter. The Calibration report is generated and displayed.
4 Press F8 to obtain a hard copy of the report.

8.4.4 Raw Data Report

The Raw Data report displays the optical data for patients, controls and performance
tests.

1 Select Raw Data from the Reports menu. A list of samples with raw data
available is displayed.
2 Select, by name, the desired sample (use the arrow keys) and press
Enter. A list of tests for the sample is displayed.
3 Select the desired test (use the arrow keys) from the list.
4 Press Enter. The Raw Data report is generated and displayed.
5 Press F8 to obtain a hard copy of the report.

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8.4.5 Parameters Report

The Test Parameters report displays a table of the parameters for each test stored in the
database.

1 Select Test Parameters from the Reports menu. A list of tests is

displayed.
2 Select the desired test (use the arrow keys) from the list.
3 Press Enter. The report is generated and displayed:

4 Press F8 to print the report.

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8.4.6 Performance Report

The Performance report displays results for the last performance diagnostic.

1 Select Performance from the Reports menu. A list of all performance

reports available is displayed.

? Note: The available reports are displayed by type of

performance diagnostic run (chemistry and/or ISE).

2 Select the desired type (use the arrow keys).

3 Press Enter. The report is generated and displayed.
4 Press F8 to print the report.

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8.4.7 Journal Report

The system maintains a series of journals that provide a permanent record of system
events. A report may be generated for each journal. Each of the journal reports is
prepared in a similar way. An example is provided below.

1 Select Journals from the Main menu.

2 Select the desired journal. A range of dates for the report is displayed:

? Note: The procedure for preparing an audit journal is described in the

following steps. Each of the other journal reports is prepared in a similar
manner. Follow the instructions on the screen.

3 Enter the date range for the report. Press F2 to display a list of events.
4 Highlight an event (using the arrow keys) and press Enter to select an
individual event.

? Note: Select ALL to include all events in the journal report.

5 Press F10. The report is generated and displayed.

6 Press F8 to print the report.

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8.5 System Backup and Restoration

A full system backup should be performed at the end of each day to save the most
current patient and QC data as well as the most current system data files. The Restore
function allows the system data from the most current backup disk to be restored in the
unlikely event of a hard disk failure.

8.5.1 System Backup

1 Select Utilities from the Main menu.

2 Select Backup. Instructions for inserting a 3.5 inch disk are displayed.
3 Insert a formatted 3.5 inch disk into drive A.

? Note: Use a 3.5 inch IBM-compatible disk.

4 Press F10. A status message is displayed, and then the name of each file
is displayed as it is copied to the 3.5 inch disk.
5 When the backup is complete, instructions to remove the 3.5 inch disk are
displayed.
6 Remove the 3.5 inch disk and press any key. The system is initialized and
the Utilities menu is displayed.
7 Label the 3.5 inch disk and store it in a safe place.

? Note: As a precautionary measure, you may wish to repeat the

backup using a second disk or alternate disks by day.

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8.5.2 Restoring System Data

1 Select Utilities from the Main menu.

2 Select Restore. The Restore menu is displayed.
3 Select System Data. Instructions are displayed.
4 (If necessary) Type the password and press Enter. Instructions are
displayed.

? Note: The password is designated during system configuration.

5 Insert the most recent system backup disk into drive A.

6 Press F10. A message to confirm the data restoration is displayed.

? Note: Any changes to patient requisitions, QC data, setup data,

and test calibration status that were made since the backup will
be lost.

7 Press F10. A status message is displayed, and then the name of each file
is displayed as it is copied from the disk to the system.
8 When the restoration is complete, instructions to remove the 3.5 inch disk
are displayed.
9 Remove the backup disk and press any key. The system is initialized and
the Utilities menu is displayed.

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8.6 Archiving and/or Deleting Patient Files

The Delete/Archive function allows patient files to be archived to a 3.5 inch disk and/or
deleted.
If patient files are being deleted without archiving and the Archiving mode is enabled
during system configuration (page 220), the user is prompted to archive the files before
they are deleted. Otherwise, the files will be deleted directly on command.

8.6.1 Archiving Patient Files

1 Select Delete/Archive from the Main menu, select Delete/Archive

Patients, then select Archive Without Deleting.

? Note: This option allows you to archive the patient data onto a
disk without deleting the patient data on the system.

2 Type the date after which inactive patients and/or requisitions should be
archived.

? Note: Enter the date using the date format (MM/DD/YY or

DD/MM/YY) specified during system configuration.

3 Press F10. The patient data selected for archiving is displayed.

4 Review the list of patients.

? Note: A patient can be excluded from the archive list by selecting

the patient (using the arrow keys) and pressing Delete.

5 Press F10. A message to confirm the archiving is displayed.

? Note: Depending on the number of patients, the archiving may take

an extended period of time and require more than one 3.5 inch disk.

6 Press F10. If patient files have never been archived on the system, a
message to confirm the creation of an archive history log is displayed.
7 Press F10. The archive log is created and instructions to insert a 3.5 inch
disk are displayed.

? Note: If patient files were previously archived on the system but the
archive log was not found, press Esc and restore the log using the
Utilities menu.

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8 Insert a formatted 3.5 inch disk into drive A.

? Note: Use a 3.5 inch IBM-compatible disk.

9 Press F10. A status message is displayed as patient data is copied to the

3.5 inch disk.
10 When archiving is complete, instructions to remove the 3.5 inch disk are
displayed.
11 Remove the 3.5 inch disk and press any key.
12 Label the 3.5 inch disk and store it in a safe place.

8.6.2 Restoring the Archive Log

Each time an archive is performed, the archive history is updated on the hard drive (on
the archive log). The updated archive log is included with the patient files whenever an
archive is performed. If necessary, the archive history log can be restored from the most
recent archive disk.
1 Select Utilities from the Main menu.
2 Select Restore. The Restore menu is displayed.
3 Select Archive Log. If an archive log already exists on the hard drive, a
warning is displayed:

4 Insert the most recent archive disk into drive A.

5 Press F10. The archive log is displayed.

6 Press F10. A message is displayed as the archive log is copied from the
3.5 inch disk to the system.
7 When the restoration is complete, instructions to remove the 3.5 inch disk
are displayed.
8 Remove the disk and press any key. The system is initialized and the
Restore menu is displayed.

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8.6.3 Archiving and then Deleting Inactive Files

1 Select Delete/Archive from the Main menu, select Delete/Archive

Patients, then select Both Archive and Delete. If archiving is not
specified in system configuration, a warning message is displayed:

? Note: Ignore the message, since the records will be archived.

2 Type the date after which inactive patients and/or requisitions should be
archived and then deleted, and then press Enter.

? Note: Enter the date using the date format (MM/DD/YY or

DD/MM/YY) specified during system configuration.

3 Press F2 to select the records (REQS AND PATIENTS or REQS ONLY)

that should be archived and then deleted.

4 Press F10. The patient data selected for archiving and deletion is
displayed.

5 Review the list of patients.

? Note: A patient can be excluded from the deletion list by

selecting the patient (using the arrow keys) and pressing Delete.

6 Press F10. A message to confirm the archiving is displayed.

? Note: Depending on the number of patients that are being purged,

the archiving may take an extended period of time and require more
than one 3.5 inch disk.

7 Press F10. If patient files have never been archived on the system, a
message to confirm the creation of an archive history log is displayed.
8 Press F10. The archive log is created and instructions to insert a 3.5 inch
disk are displayed.

? Note: If patient files were previously archived on the system but the
archive log was not found, press Esc and restore the log using the
Utilities menu.

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9 Insert a formatted 3.5 inch disk into drive A.

? Note: Use a 3.5 inch IBM-compatible disk.

10 Press F10. A status message is displayed as patient data is copied to the

3.5 inch disk.
11 When the backup is complete, instructions to remove the 3.5 inch disk are
displayed.
12 Remove the 3.5 inch disk and press any key. The selected patient data is
purged from the system.
13 The screen displays “Purging Patients”and returns to the Purge menu
when done.
14 Label the 3.5 inch disk and store it in a safe place.

8.6.4 Displaying or Printing a Patient Requisition from an Archive

1 Select Reports from the Main menu.

2 Select Patient. The Patient Report menu is displayed.
3 Select Archived. The archive log is displayed with instructions to insert
the archive disk.
4 Insert the appropriate archive disk into drive A.

5 Press F10. A list of archive sessions is displayed.

6 Select the desired archive session and press Enter. A list of patients is
displayed.
7 Select the desired patient and press Enter. The selected requisition is
displayed.
8 Press F8 to print the requisition.
9 Press Esc to return to the patient list and repeat if needed.
10 When completed, press Esc until a prompt to remove the 3.5 inch disk is
displayed.
11 Remove the 3.5 inch disk and press any key.
12 Press Esc until the Main menu is displayed.

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8.6.5 Deleting Inactive Files without Archiving

1 Select Delete/Archive from the Main menu, select Delete/Archive

Patients, then select Delete Without Archiving. If archiving is not
specified in system configuration, a warning message is displayed:

2 If you wish to delete patient data without archiving to disk, press F10. A
prompt is displayed to enter the starting date for the period of inactivity
and to specify the records that are to be deleted.

? Note: If you wish to archive the patient data before deleting,

press Esc to discontinue the deletion procedure. Then, enable
the Archiving mode (page 220) and repeat the deletion
procedure.

3 Type the date after which inactive patients and/or requisitions should be
deleted, and then press Enter.

? Note: Enter the date using the date format (MM/DD/YY or

DD/MM/YY) specified during system configuration.

4 Press F2 to select the records (REQS AND PATIENTS or REQS ONLY)

that should be deleted.

5 Press F10. The patient data selected for deletion is displayed.

6 Review the list of patients. Delete any from the purge list, if desired.

? Note: Exclude a patient from the purge list by selecting the

patient (using the arrow keys) and pressing Delete.

7 Press F10. The selected patient data is deleted from the system.

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8.7 Deleting Test Counts

The system maintains a test counter for each on-line photometric test. The counter may
be reset to zero for all tests or for individual tests.

? Note: A calibration (or correction) requisition is recorded as one test.

8.7.1 Resetting All Counts

1 Select Delete/Archive from the Main menu. The Delete/Archive menu is

displayed.

2 Select Delete Test Counts. The Test Counts screen is displayed listing
the test name, the number of tests run since the last reset and the date the
counter was last reset.

3 Press F5. A check mark is displayed next to each test name.

? Note: This indicates all test counters have been marked for
reset.

4 Press F10. All counters are reset to zero and the changes are saved.

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8.7.2 Resetting Individual Counts

1 Select Delete/Archive from the Main menu. The Delete/Archive menu is

displayed.

2 Select Delete Test Counts. The Test Counts screen is displayed listing
the test name, the number of tests run since the last reset and the date the
counter was last reset.

3 Select the desired test (use the arrow keys).

4 Press Enter. A check mark is displayed next to the test name.
5 Repeat steps 3 and 4 to mark additional tests.
6 Press F10. The selected counters are reset to zero and the changes are
saved.

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8.8 Deleting Patient Data

? Note: The following procedures are available only if archiving of patient

data is not required.

Individual tests and requisitions for a patient can be deleted if archiving is not required. If
all tests on a requisition are to be deleted, the entire requisition must be deleted. If all
requisitions for a patient are to be deleted, the patient must be deleted.

8.8.1 Deleting a Test

Refer to section 6.3.1 on page 114.

8.8.2 Deleting a Requisition

? Note: A requisition cannot be deleted if archiving of patient data is

required (see page 220).

1 Select Patient from the Requisitions menu. A list of patients that have
already been entered into the system is displayed:

? Note: To locate a name quickly, the Patient list can be sorted by

entering the first character(s) of the name in the name field.

2 Select the desired patient (using the arrow keys) and press Enter. A list of
requisitions for the patient is displayed:

3 Select the desired requisition (using the arrow keys) and press Delete. A
message to confirm the deletion is displayed.
4 Press Y. The requisition is deleted.

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8.8.3 Deleting a Patient

1 Select Patient from the Requisitions menu. A list of patients that have
been entered into the system is displayed:

? Note: To locate a name quickly, the Patient list can be sorted by

entering the first character(s) of the name in the name field.

2 Select the desired patient (using the arrow keys) and press Delete. The
message This patient will be removed from the system. Are you sure
you want to do this (Y/N)? is displayed.
3 Press Y. The patient is deleted.

? Note: If the patient has at least one test without a result, the
message This patient has at least one incomplete requisition.
Do you want to delete this patient anyway (Y/N) ? is displayed.
Press Y to delete the patient.

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9 System Setup

The system hardware and software can be configured to meet the needs and
requirements of an individual laboratory. Configuration is carried out using the Setup
menu.

1 Select Setup from the Main menu. The Setup menu is displayed:

2 Select the appropriate configuration command.

9.1 Hardware Setup

9.1.1 Enabling the ISE Module

1 Select Hardware to display the hardware configuration screen:

2 Select ENABLE: (under ISE) and press F2. The screen displays YES and
NO options.

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3 To enable the ISE, select YES and press Enter. To disable the ISE, select
NO and press Enter.
4 Press F10 to save the changes.

? Note: Once enabled, the ISE module should only be disabled if the
system is scheduled for a long-term period of inactivity. See the
Maintenance section for instructions for long-term shutdown of the
ISE.

9.1.2 Setting the ISE Calibration Mode

The ISE can be run in either Standby mode or STAT Ready mode.

? Note: If the ISE is set to Standby mode, calibration is only performed when a
sample is introduced for ISE testing and the last calibration was more than
three hours ago. This reduces the amount of CAL-A and CAL-B used by the
system.

If the ISE is set to STAT Ready mode, calibration is performed every three
hours even if samples are not processed.

1 Select Hardware to display the hardware configuration screen:

2 Select CALIBRATION: (under ISE) and press F2. The screen displays
STANDBY and STAT READY options.
3 Select the desired mode and press Enter.
4 Press F10 to save the changes.

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9.1.3 Enabling the Laboratory Information Management System (LIMS)

The ACE Alera System can be interfaced with an external data management system that
downloads requisitions and accepts the transmission of completed requisitions
(unidirectional or bidirectional). Certain parameters must be entered when the LIMS is
enabled. Specific values for these parameters are supplied with the LIMS system.

1 Select Hardware to display the hardware configuration screen:

2 Select ENABLE: (under LIMS) and press F2. The screen displays YES
and NO options.
3 Select YES and press Enter. The BAUD RATE: field is selected.

? Note: Select NO and press Enter to disable the LIMS. Then, press
F10 to save the changes

4 Press F2. The screen displays 1200, 2400, 4800 and 9600 options.
5 Select the appropriate baud rate and press Enter. The PARITY: field is
selected.
6 Press F2. The screen displays NONE, ODD and EVEN options.
7 Select the appropriate parity and press Enter. The DATA BITS: field is
selected.
8 Type the appropriate number (7 or 8) of data bits and press Enter. The
STOP BITS: field is selected.
9 Type the appropriate number (1 or 2) of stop bits.
10 Press F10 to save the changes.

? Note: Enabling LIMS requires that transmission of patient reports

and QC reports are configured (see section 9.10.9 on page 221).

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9.1.4 Specifying Entry of Patient First Name

The ACE Alera System can be configured so that a patient first name is required in all
patient requisitions.

1 Select Hardware to display the hardware configuration screen:

2 Select FIRST NAME REQUIRED: and press F2. The screen displays YES
and NO options.
3 To specify that the patient’s first name is required in a patient requisition,
select YES and press Enter. Otherwise, select NO and press Enter.

? Note: If the FIRST NAME REQUIRED: field is set to YES, the

instrument will reject any LIMS-originated or manually-entered
patient requisition that does not include a patient first name.

Changing this field to YES may cause serious problems if the

instrument is connected to a LIMS. It is recommended that you
contact Alfa Wassermann Diagnostic Technologies, LLC Technical
Service for instructions before changing this field to YES on an
instrument connected to a LIMS.

4 Press F10 to save the changes.

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9.1.5 Disabling Reagent Temperature Control

? Note: Refrigeration of the reagent compartment can be disabled to

conserve energy when the reagents are removed from the system
and stored in a refrigerator overnight or on weekends. Disabling the
refrigeration will reduce condensation within the compartment.
Remember to enable refrigeration before returning the reagent tray to
the reagent compartment.

1 Select Hardware to display the hardware configuration screen:

2 Select ENABLE: (under REAGENT TEMPERATURE) and press F2. The

screen displays YES and NO options.
3 To disable reagent temperature control, select NO and press Enter. To
enable reagent temperature control, select YES and press Enter.
4 Press F10 to save changes. The system will reinitialize and return to the
Setup menu.

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9.1.6 Adjusting the Volume of the Audible Alarm

An audible alarm sounds when an attention message is displayed. The sound level of
the alarm can be adjusted.

? Note: HIGH is the default volume for the alarm.

1 Select Hardware to display the hardware configuration screen:

2 Select LEVEL: (under BEEPER LEVEL) and press F2. The screen
displays HIGH, MEDIUM and LOW options.
3 Select the desired level and press Enter.
4 Press F10 to save the changes. The system will reinitialize and return to
the Setup menu.

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9.1.7 Specifying the Type of Barcode Scanner

The ACE Alera System can be equipped with an optional barcode reader. The default
scanner type is PSC.

? Note: The default barcode scanner is preprogrammed and should not be

changed without prior notification from Alfa Wassermann Diagnostic
Technologies, LLC.

1 Select Hardware to display the hardware configuration screen:

2 Select TYPE: (under BARCODE SCANNER) and press F2. The screen
displays NONE, MSCAN and PSC options.
3 Select the desired option and press Enter.

? Note: Setting the scanner type to NONE disables all barcode

reader functions and related screens. For example, the Label
Symbology selection will not appear on the Setup menu.

4 Press F10 to save the changes. The system will reinitialize and return to
the Setup menu.

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9.1.8 Specifying Label Symbology

? Note: For systems with an optional barcode reader.

The default label symbology parameters are preprogrammed. They are applicable to
barcode labels for Code 39, Code 128 Set B and Set C, Codabar or Interleaved 2 of 5.

? Note: This configuration option is to be used at the discretion of LIS/LIMS

consultants or departments.

1 Select Label Symbology from the Main menu. The Label Symbology form
is displayed:

2 (If needed) Select the first field (using the arrow keys) for the type of
barcode label you are using.
3 Type a value in the field and press Enter. The next field is selected.
4 Repeats Steps 2 and 3 for each label parameter.

5 Press F10 to save the selections.

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9.1.9 Specifying Sample Lifetime

Sample lifetime is the length of time (in hours) that a sample may remain on the
analyzer awaiting testing before it is considered expired. The status of a sample is
automatically changed from active to expired if this lifetime is exceeded. If there are
pending tests for the sample, the operator is notified that the sample should be replaced.

1 Select Hardware to display the hardware configuration screen:

2 Select HOURS: (under SAMPLE LIFETIME) and press F2. The screen
displays the sample lifetime options.
3 Select the desired option and press Enter.

4 Press F10 to save the changes.

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9.1.10 Specifying Suppression of Leading Zeros in the Accession

The ACE Alera System can be configured so that leading zeros are removed from
Accession numbers that are read from barcode labels or entered by the operator.

? Note: This option is provided for backward compatibility with certain

LIMS systems. For most new installations, leading zeros should not
be suppressed.

1 Select Hardware to display the hardware configuration screen:

2 Select LEADING ZERO SUPPRESSION: and press F2. The screen

displays YES and NO options.
3 To enable suppression of leading zeros, select YES and press Enter.
Otherwise, select NO and press Enter.

? Note: If YES is selected, leading zeros will be suppressed from

alphabetic as well as numeric Accessions. For example, the
Accession 00AABBCC will be changed to AABBCC if YES is
selected.

4 Press F10 to save changes.

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9.2 Test Parameters

The ACE Alera System can store parameters for up to 200 different tests. Most of the
parameters for preprogrammed tests cannot be changed without written notification from
the manufacturer.
Caution: Test parameters are preprogrammed by Alfa Wassermann
Diagnostic Technologies, LLC and have been used for method validation.
Only test parameters outlined in this section may be modified. Modification
to any analytical parameters without manufacturer’s notification will
invalidate performance claims.

A few of the test parameters can be customized to accommodate the needs of the
individual laboratory. For example, reference intervals and QC checking rules can be
modified in the individual test parameters.

1 Select Tests from the Setup menu. The Setup Tests list is displayed,
showing all tests that are defined in the system and the date each test was
last edited:

2 Select the test for which a parameter is to be edited. The Photometric

Parameter Groups menu is displayed:

3 Select the group of parameters that is to be customized.

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The parameters that can be modified within each parameter group are summarized
below:

Parameter Group Modifiable Parameters

Test Identification Test name and mnemonic.

Loading Method Pre Dilution and Auto Rerun Dilution Ratios.

Calculation Method Calibrator concentrations, LT LC, and LT 0 selections,

correction method.

Result Type Reporting units and number of decimal places.

Reference Range Checks All parameters may be modified.

Quality Control Checks All parameters may be modified.

9.2.1 Modifying a Test Name or Mnemonic

1 Select Test Identification. The current test identification parameters are

displayed:

2 Edit the test name and test mnemonic fields as needed.

? Note: The test mnemonic is an abbreviation for the test name. The
abbreviation can consist of up to six (6) alphanumeric characters,
but it must begin with a letter.

3 Press F10. The Parameter Groups menu is displayed. A check mark is

displayed next to Test Identification if changes were made.

? Note: If no further changes are to be made, press F10 to save

the changes and return to the Setup Tests list.

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9.2.2 Modifying Predilution or Auto Rerun Dilution Ratios

1 Select Loading Method. The loading method parameters are displayed

for the selected test:

? Note: Predilution ratios and auto rerun dilution ratios are the only
fields which may be modified.

2 To modify the predilution ratio, select the RATIO: field of the PREDILUTE:
row.
Then, type the predilution ratio (between 2 and 101) and press Enter.

3 To modify the dilution ratio used during automatic rerun, select the RATIO:
field of the AUTO RERUN: row.
Then, type the dilution ratio (between 2 and 50) and press Enter.

? Note: Certain preconditions must exist for the system to accept

auto rerun (limit settings for linearity and/or substrate depletion to
trigger the dilution). Follow screen prompts if these preconditions
are not met.

4 Press F10. The Parameter Groups menu is displayed. A check mark is

displayed next to Loading Method if changes were made.

? Note: If no further changes are to be made, press F10 to save

the changes and return to the Setup Tests list.

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9.2.3 Modifying Calculation Method Parameters

This screen is used to allow reporting of results that are less than the lowest calibrator
(LT LC) or less than zero (LT 0). It can also be used to change the concentration of the
calibrator(s) used for a test.

? Note: Calibrator concentrations can also be edited by selecting Calibrators

from the Setup menu (see page 203).

1 Select Calculation Method. The calculation method parameters are

displayed for the selected test:

2 To modify a calibrator concentration, select the appropriate row of the

CONCENTRATION field. Then, type the concentration (from the calibrator
package insert) and press Enter.
3 Repeat Step 2 for each level of calibrator concentration to be modified.

? Note: The calibrator lot number can not be edited from this
screen since it is not test specific. Use the Setup Calibrators
screen
(page 204) to update calibrator lot numbers.

4 To allow LT LC result reporting, select the ACCEPT LT LC: field, using

the arrow keys.

? Note: The screen will not allow access to the LT LC and LT 0

fields if the choice is not applicable for the test.

5 Press F2 and select Yes.

? Note: Selecting Yes suppresses display of the attention

message normally shown when such a condition occurs. This
eliminates the need to manually verify the result.

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6 To allow LT 0 result reporting, select the ACCEPT LT 0: field.

7 Press F2 and select Yes.

? Note: Selecting Yes suppresses display of the attention

message normally shown when such a condition occurs. This
eliminates the need to manually verify the result.

8 To allow a correction method, press F2 and select the appropriate

correction method [NONE (default), SLOPE, or OFFSET], then press Enter.
Under the corrector name, type the corrector or press F2 to select the
corrector assigned for the test.

9 Press F10. The Parameter Groups menu is displayed. A check mark is

displayed next to Calculation Method if changes were made.

? Note: If no further changes are to be made, press F10 to save

the changes and return to the Setup Tests list.

9.2.4 Modifying the Result Units or Decimal Places

1 Select Result Type. The result type parameters are displayed for the
selected test:

2 To modify the result units, select the UNITS: field, press F2, and select the
appropriate units.

? Note: Electrolytes may be reported in units of mmol/L or mEq/L.

3 To modify the result number of decimal places, select the NUMBER OF

DECIMAL PLACES: field. Then, type the new number (0 to 4) and press
Enter.

? Note: If the number of decimal places is changed, the

Calculation Method Parameters screen must be reviewed and
saved again.

4 Press F10. The Parameter Groups menu is displayed. A check mark is

displayed next to Result Type if changes were made.

? Note: If no further changes are to be made, press F10 to save

the changes and return to the Setup Tests list.

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9.2.5 Modifying Reference Ranges

A range of normal or expected values can be assigned for each test, and separate
normal ranges can be established based on gender and/or age.
The system can automatically check test results against these normal ranges and flag
any result that is outside of the normal range. The system can also check results against
an upper and lower panic limit and display a VERIFY warning if results are outside the
limits.

? Note: All reference range parameters can be modified.

1 Select Reference Range Checks. The reference range parameters are

displayed for the selected test:

2 Press F2 and select YES at NORMAL RANGE CHECKS: to automatically

check patient results against the normal range and flag abnormal results
on the patient report.
3 Press F2 and select YES at NORMAL RANGE SEX DISTINCTION: if the
normal ranges for male and female are not the same.
4 Enter or modify an age at FIRST CUTOFF AGE: if there is a different
normal range for a particular age group.
5 Enter or modify ages at SECOND CUTOFF AGE: and THIRD CUTOFF
AGE: if there are different normal ranges for these age groups.
6 Enter or change the normal ranges for the groups as desired.
7 Press F2 and select YES at LOWER PANIC CHECK: to check against a
lower panic limit. Enter or change the panic value at LIMIT:.
8 Press F2 and select YES at UPPER PANIC CHECK: to check against an
upper panic limit. Enter or change the panic value at LIMIT:.
9 Press F10. The Parameter Groups menu is displayed. A check mark is
displayed next to Reference Range Checks if changes were made.

? Note: If no further changes are to be made, press F10 to save

the changes and return to the Setup Tests list.

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9.2.6 Enabling or Disabling Quality Control Checks

The system can automatically check control value statistics. A notation is made on the
QC Requisition Report if one of the selected checks is violated. These values will also
be flagged on any Quality Control plots.

1 Select Quality Control Checks. The quality control check parameters are
displayed for the selected test:

2 To generate a flag if one control value is outside a defined standard

deviation (SD) range, select the first field, press F2, select YES, and press
Enter.
3 To specify the value of the SD, select the SD: field, press F2, select the
SD value from the list, and press Enter.
4 To generate a flag when other control checks are violated, select the
appropriate field, press F2, select Yes, and press Enter.

5 Press F10. The Parameter Groups menu is displayed. A check mark is

displayed next to Quality Control Checks if changes were made.

? Note: If no further changes are to be made, press F10 to save

the changes and return to the Setup Tests list.

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9.2.7 Creating a New Test

? Important: It is the responsibility of the laboratory to validate the performance

of a new test before reporting results on patient samples.

1 Select Tests from the Setup menu. The Setup Tests list is displayed:

2 Press Insert. The types of tests that can be created are displayed:

3 Select the test type. The Parameter Groups menu is displayed:

? Note: The parameter groups that are displayed depend upon the
type of test that is to be created.

4 Define the parameters for the test.

5 Press F10 to save the parameters.

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9.3 Special Tests

Four types of special tests can be configured on the system. These special tests are
summarized below:

Special Test Purpose

Off-Line Tests Tests that are run on other instruments. Results of off-line tests
are entered using the ACE Alera System keyboard so they can
be included on the ACE Alera System Patient Report or in QC
statistics.

Derived Tests Tests with results that are calculated from the results of other
tests. For example, a BUN/Creatinine Ratio may be a derived by
dividing BUN results by the Creatinine results..

Calculation Tests Information other than a chemistry test result that may be
required in the calculation of a derived test result. For example,
body weight may be required.

Remote Tests Tests that are run using more than one sample. The results of
(Linking Tests) remote tests are linked so they can be included on a patient
report.

Remote tests can be used in a derived test calculation method

that requires test results from multiple requisitions. Glucose
tolerance is an example of remote test.

9.3.1 Off-Line Test

1 Select Tests from the Setup menu. The Setup Tests list is displayed.
2 Press Insert. The types of tests that can be created are displayed.
3 Select OFF-LINE from the Test Type menu. The Parameter Groups menu
for offline tests is displayed:

4 Define the test identification, result type, reference range checks, and
quality control checks. Refer to pages 192 through 197 for details.
5 Press F10 when all parameters have been entered to save the test and
return to the Setup Tests list.
6 Press Esc to return to the Setup menu.

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9.3.2 Derived Test

1 Select Tests from the Setup menu. The Setup Tests list is displayed.
2 Press Insert. The types of tests that can be created are displayed.
3 Select DERIVED from the Test Type menu. The Parameter Groups menu
for derived tests is displayed:

4 Define the test identification, result type and reference range checks.
Refer to pages 192 through 196 for details.
5 Select Calculation Method. A prompt is displayed for the equation
needed to calculate the result of the derived test:

6 Type the exact equation for the calculation.

? Note: For example, the equation for calculating BUN/Creatinine

Ratio results of BUN and Creatinine may be entered as
BUN/CREAT.

7 Press F10. The Parameter Groups menu is displayed.

8 When all parameters have been entered for the derived test, press F10 to
save the test and return to the Setup Tests list.
9 Press Esc to return to the Setup menu.

? Note: When a derived test is ordered, the system automatically

orders the other tests required to calculate the derived test
results.

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9.3.3 Calculation Test

1 Select Tests from the Setup menu. The Setup Tests list is displayed.
2 Press Insert. The types of tests that can be created are displayed.
3 Select CALCULATION from the Test Type menu. The Parameter Groups
menu for calculation tests is displayed:

4 Define the test identification and result type. Refer to pages 192 and 195
for details.
5 When all parameters have been entered for the calculation test, press F10
to save the test and return to the Setup Tests list.
6 Press Esc to return to the Setup menu.

9.3.4 Remote Test

1 Select Tests from the Setup menu. The Setup Tests list is displayed.
2 Press Insert. The types of tests that can be created are displayed.
3 Select REMOTE from the Test Type menu. The Parameter Groups menu
for remote tests is displayed:

4 Define the test identification. Refer to page 192 for details.

? Note: The test mnemonic used to identify a remote test on a

patient report must be different from the mnemonic of the on-line
test to which it will be linked.
For example, a remote test for a glucose 1 hour could be set up
as follows:
Reported Test Name: GLU_1HR
Source Test Name: GLU

5 Select Source Test. A prompt is displayed to enter the mnemonic of the

source test.

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6 Type the mnemonic for the source test and press Enter.
Or: Press F2 to display a list of tests and test panels that are available.
Select the desired test (use the arrow keys) and press Enter:

7 Press F10. The Parameter Groups menu is displayed.

8 When all parameters have been entered for the remote test, press F10 to
save the test and return to the Setup Tests list.
9 Press Esc to return to the Setup menu.

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9.4 Calibrators
Up to 250 different calibrators can be defined on the system at one time. The name of
the calibrator, the lot number, the analytes it contains, the concentration of each analyte,
and the interval between calibrations for each analyte is specified.

9.4.1 Defining Calibrators

The number of calibrators for a test and the specific calibrators that are used are defined
in the calculation parameters (page 194).

Caution: The number of calibrators for a test and the calibration frequency are
preprogrammed by Alfa Wassermann Diagnostic Technologies, LLC and have
been used for method validation. Modification to these parameters without
manufacturer’s recommendation will invalidate performance claims.

9.4.2 Modifying Information for a Calibrator

Once calibrators for a test are defined, the lot number and analyte concentrations in a
calibrator can be conveniently modified. For example, when using a multi-constituent
calibrator (e.g., GEMCAL? ), the lot number and concentrations of all constituents can be
updated from one screen.

? Note: Calibrator concentrations for an individual test can also be edited from
the calculation method parameters screen for that test (see page 194).

1 Select Calibrators from the Setup menu. A list of calibrators that are
currently defined on the system is displayed:

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2 Select the desired calibrator and press Enter. The Setup Calibrators
screen for the selected calibrator is displayed with the entered values for
the calibrator:

3 (If needed) Type a new lot number for the calibrator and press Enter.
4 Select the CONCENTRATION field for each constituent and modify the
value as desired.
5 Press F10 to save all changes.

9.4.3 Deleting a Calibrator

? Note: A calibrator cannot be deleted if it is defined in a test parameter group.

1 Select Calibrators from the Setup menu. A list of calibrators that are
currently defined on the system is displayed.
2 Select the desired calibrator and press Delete. The selected calibrator is
removed from the list.

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9.5 Controls
Up to 20 different controls can be defined on the system at one time. A particular test
(albumin, for example) can be specified in up to six defined controls.

9.5.1 Defining a New Control

1 Select Quality Control from the Setup menu. A list of controls that are
currently defined on the system is displayed:

2 Press Insert. A screen for setting up a new control is displayed.

3 Enter the name and lot number for the control.

4 Select the TEST field, type the mnemonic of the first test (for example,
ALB), and press Enter.
Or: Select the TEST field and press F2 to display a list of tests and test
panels that are available. Select the desired test (use the arrow keys) and
press Enter.

5 Enter the expected values (mean and SD) for that test.

? Note: Refer to the package insert for the expected values.

6 Repeat Steps 4 and 5 for each test for which the control will be used.
7 When all tests have been entered, press F10 to save the entries.

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9.5.2 Modifying Expected Values for a Control

1 Select Quality Control from the Setup menu. The list of controls is
displayed.
2 Select the desired control and press Enter. Information for the selected
control is displayed:

3 Using the arrow keys, select the first TEST field for which expected values
are to be updated. Press Enter to select the MEAN field for that test.

? Note: Refer to the package insert for the expected values.

4 Type the new mean value and press Enter. The SD field for that test is
selected.
5 Type the new SD value and press Enter.
6 Repeat Steps 3 and 4 for each test for which expected values are to be
updated.
7 To delete a test from the control, select the test and press Delete.

? Note: If a test is deleted, all control data for that test is lost.

8 Press F10 to save all changes.

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9.5.3 Modifying the Lot Number for a Control

1 Select Quality Control from the Setup menu. The list of controls is
displayed.
2 Select the desired control and press Enter. Information for the selected
control is displayed.
3 Using the arrow keys, select the LOT: field.
4 Type the new lot number and press Enter. A warning message is
displayed:

? Note: If the entry in the NAME: field is modified, purging of data

does not occur.

5 Type Y to purge accumulated data for the existing lot number and print an
end-of-lot report.
6 If needed, enter updated expected values (page 206).

? Note: Refer to the package insert for the expected values.

7 Press F10 to save all changes.

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9.5.4 Deleting a Control

1 Select Quality Control from the Setup menu. The list of controls is
displayed.
2 Select the control that is to be deleted and press Delete. A warning
message is displayed:

3 Type Y to confirm the deletion. The screen displays:

4 Type Y to print the data or N if a printout is not desired. The control is

removed from the system.

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9.6 User-Defined Reagent Bottles

Bottles for all Alfa Wassermann Diagnostic Technologies, LLC reagents are
preprogrammed and predefined in the ACE Alera System software.
Other reagent bottles (open channel bottles) can be used on the system. However, a
reagent bottle must be configured before it can be specified when entering a new test.

? Note: Modifications to predefined bottle parameters without prior notification

from Alfa Wassermann Diagnostic Technologies, LLC will invalidate performance
claims.

Open channel bottles are available from your Alfa Wassermann Diagnostic
Technologies, LLC distributor.

It is recommended that you contact Alfa Wassermann Diagnostic Technologies,

LLC Technical Service for instructions regarding open channel bottles.

1 Select Bottles from the Setup menu. A list of reagent bottles that are
currently defined on the system is displayed:

2 Press Insert. A form for entering bottle parameters is displayed:

3 Type the reagent abbreviation (up to ten characters) in the

BOTTLE NAME: field and press Enter. The BOTTLE ID: field is selected.
4 Type the numeric code (found on the open channel bottle label) and press
Enter. The FLUID TYPE: field is selected.
5 Press F2 to display choices for fluid type (BUFFER, DYE or REAGENT).
Select a fluid type (using the arrow keys) and press Enter. The first
LIFETIME: field is selected.
6 Type numerals (one or two characters) for the period of time the reagent
can be used on the system and press Enter. The second LIFETIME: field
is selected.

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7 Press F2 to display choices for lifetime units (Days, Hours, Months or

Weeks). Select a lifetime unit (using the arrow keys) and press Enter.
8 Press F10 to save the entry.

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9.7 Configuring Test Panels

A group of tests that are frequently performed together can be defined as a panel.
Panels can be requested in the same manner as an individual test. Up to 16 different
panels can be defined on the system at one time.

9.7.1 Defining a Panel

1 Select Panels from the Setup menu. The Panels list is displayed.

? Note: If no panels exist, a blank Setup Panels screen (see

below) is displayed instead.

2 Press Insert. The Setup Panels screen is displayed:

3 Type a name for the panel in the PANEL NAME: field and press Enter.
The field for the first test to be included in the panel is selected.

? Note: The panel name can contain up to six alphanumeric

characters.

4 Type the mnemonic for the test and press Enter.

Or: Press F2 to display a list of tests. Select the desired test (use the
arrow keys) and press Enter:

5 Repeat Step 4 for each test to be included in the panel.

6 Press F10 to save the entries for the panel.

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9.7.2 Modifying a Panel

1 Select Panels from the Setup menu. The Panels list is displayed.
2 Select the desired Panel and press Enter to display the Setup Panels
screen for the selected Panel.
3 Edit the Panel as required.
4 Press F10 to save the changes.

9.7.3 Deleting a Panel

1 Select Panels from the Setup menu. The Panels list is displayed.
2 Select the desired Panel and press Delete.
3 The panel is deleted from the list of panels.

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9.8 Configuring the Doctor List

A list of doctors can be maintained on the system so that the doctor’s name can be
selected from the list during entry of information. Up to 200 different doctors can be
defined on the system at one time.

9.8.1 Adding a Doctor’s Name

1 Select Doctors from the Setup menu. The Doctors list is displayed.

? Note: If no doctors exist, a blank Setup Doctors screen (see

below) is displayed instead.

2 Press Insert. The Setup Doctors screen is displayed:

3 Type a name for the doctor in the NAME: field and press F10. The
doctor’s name is added to the list.

? Note: The doctor’s name can contain up to 20 characters.

9.8.2 Modifying a Doctor’s Name

1 Select Doctors from the Setup menu. The Doctors list is displayed.
2 Select the desired name and press Enter to display the Setup Doctors
screen.
3 Edit the name as required.
4 Press F10 to save the changes.

9.8.3 Deleting a Doctor’s Name

1 Select Doctors from the Setup menu. The Doctors list is displayed.
2 Select the desired name and press Delete.
3 The doctor’s name is deleted from the list.

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9.9 Configuring Carryover Parameters

Carryover of a certain reagent into a cuvette containing a susceptible reagent may
adversely affect test results. To prevent this, the system can be configured to specifically
rinse the probe after a contaminating reagent before the susceptible reagent is
aspirated.

? Note: Where required, additional rinses have been preprogrammed by Alfa

Wassermann Diagnostic Technologies, LLC for predefined tests. Modifications to
carryover screens without prior recommendation from Alfa Wassermann
Diagnostic Technologies, LLC will invalidate performance claims.

9.9.1 Specifying a Probe Rinse

1 Select Carryover from the Setup menu. The reagents that are currently
defined on the system are displayed:

2 Select the reagent that is to be designated as either a contaminating

reagent or a decontaminating reagent. The Setup Carryover screen is
displayed for that reagent:

3 In the CONTAMINATES: section, type the name of the reagent that the
selected reagent affects and press Enter. Repeat for any other reagents
that the selected reagent affects.
4 In the DECONTAMINATES: section, type the name of the reagent that the
selected reagent can be used as a rinse for and press Enter. Repeat for
any other reagents that the selected reagent will decontaminate.
5 Press F10 to save the entries.

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9.10 Miscellaneous Options

Various miscellaneous options can also be configured on the system. These
miscellaneous options are summarized below:

Option Purpose
Password Specify whether a password is required in order to provide
system security.

Reminder Specify whether a reminder to run control samples is displayed at

defined intervals; reminder for scheduled maintenance.

Facility ID Specify the facility name that appears in the header of reports.

Report Footer Specify the text that is displayed in the footers of patient
requisitions and merged reports.

Archiving Mode Specify whether patient data must be archived (copied) to a

3.5 inch disk before the data are purged from the system.

Date Format Specify the date format (MM/DD/YY or DD/MM/YY) that is used
whenever a date is entered or reported.

Accessioning Mode Specify whether Accession numbers are automatically generated

by the system or must be manually entered by the operator.

Reporting Options Specify whether patient reports must be reviewed and approved
before they are printed, whether QC reports and calibration
reports are printed automatically, and whether requisitions are
automatically transmitted to a LIMS.

9.10.1 Displaying Miscellaneous Options

1 Select Miscellaneous from the Setup menu. The Miscellaneous menu is

displayed:

2 Select the option that is to be configured.

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9.10.2 Password

The system may be configured with a multi-level password system. Up to three levels of
password protection may be defined. A unique password must be entered in order to
access the menu options on that level.

? Note: The procedure for defining the levels and their corresponding passwords
is not given here for security reasons. Contact Technical Service for instructions.
Once the multilevel password system is set, level two and three passwords can
be set using the following steps:

1 Select Password. The Setup Password form is displayed:

2 Type the password in the PASSWORD: field.

3 Record the password in a secure place.

? Note: The password can contain up to ten alphanumeric characters.

? Important : Once a password is specified, it must be entered to

access certain menu options. If the password is lost or forgotten,
the software must be reinstalled. Contact your Alfa Wassermann
Diagnostic Technologies, LLC technical service representative
for additional information.

4 Press F10 to save the selection.

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9.10.3 Reminders

1 Select Reminder. The Reminder form is displayed:

2 Quality Control Reminder: Select the ENABLE QUALITY CONTROL

REMINDER: field, using the arrow keys. Press F2 to display choices (YES
and NO), select the choice (using the arrow keys), and then press Enter.
The first TIME OF DAY: field is selected.
(If enabling) Type the time of day for the first QC reminder and press
Enter. Repeat for up to two additional QC reminders during the day.

? Note: Use the 24-hour time format (e.g., 15:30 for 3:30 p.m.).

3 Maintenance Reminders: Select the ENABLE DAILY MAINTENANCE

REMINDER: field, using the arrow keys. Press F2 to display choices (YES
and NO), select the choice (using the arrow keys), and press Enter.

? Note: If the daily maintenance reminder is enabled, the reminder

will be displayed every day at 8:00 a.m.
Select the ENABLE WEEKLY MAINTENANCE REMINDER: field, using
the arrow keys. Press F2 to display choices (YES and NO), select the
choice (using the arrow keys), and press Enter.

? Note: If the weekly maintenance reminder is enabled, the

reminder will be displayed every Tuesday at 8:00 a.m.
Select the ENABLE MONTHLY MAINTENANCE REMINDER: field, using
the arrow keys. Press F2 to display choices (YES and NO), select the
choice (using the arrow keys), and press Enter.

? Note: If the monthly maintenance reminder is enabled, the

reminder will be displayed on the second Tuesday of every
month at 8:00 a.m.

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Select the ENABLE BIANNUAL MAINTENANCE REMINDER: field, using

the arrow keys. Press F2 to display choices (YES and NO), select the
choice (using the arrow keys), and press Enter.

? Note: If the biannual maintenance reminder is enabled, the

reminder will be displayed on the second Tuesday of January
and July at 8:00 a.m.
4 Press F10 to save the reminders.
The following messages will be displayed for the reminders:

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9.10.4 Facility Identification

Facility information may be entered for inclusion as a header on final reports.

1 Select Facility ID. The Facility ID form is displayed:

2 Type the facility name, address, phone number, and director as desired.

? Note: Each line can contain up to 40 characters.

3 Press F10 to save the entries.

9.10.5 Report Footer

Text may be entered for inclusion as a footer on patient reports.

1 Select Report Footer. The Report Footer form is displayed:

2 Type the report footer.

? Note: The footer can contain up to 40 characters.

3 Press F10 to save the entry.

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9.10.6 Archiving Mode

When the archiving mode is enabled, patient requisitions can not be deleted from the
database until they are copied to a floppy disk.

1 Select Archiving Mode. The Archiving Mode form is displayed:

2 Press F2 to display choices (YES and NO). Select the choice (using the
arrow keys) and press Enter.

? Note: YES enables the archiving mode, and NO disables it.

3 Press F10 to save the selection.

9.10.7 Setting the Date Format

The system date can be configured as either month/day/year or day/month/year.

1 Select Date Format. The Date Format form is displayed:

2 Press F2 to display choices (MM/DD/YY and DD/MM/YY). Select the

choice (using the arrow keys) and press Enter.
3 Press F10 to save the selection.

9.10.8 Setting the Accession Mode

The sample Accession number on a patient requisition can be entered manually or

automatically incremented by the system. The auto-incrementing mode can be
configured to reset the Accession numbers back to one (or the lowest available number)
after patient data are purged.

1 Select Accession Mode. The Accession Mode form is displayed:

2 Press F2 to display choices (MANUAL and AUTO-INCREMENTING).

Select the choice (using the arrow keys) and press Enter.

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3 (If needed) Select the AUTO ACCESSION RESET: field (using the arrow
keys) and press F2. Choices (YES and NO) are displayed. Select the
AUTO ACCESSION RESET: field (using the arrow keys) and press Enter.

? Note: If YES is selected for AUTO ACCESSION RESET,

Accession numbering will be reset to the lowest available
number after archiving patient requisitions.

4 Press F10 to save the selections.

9.10.9 Reporting Options

The Reporting Options screen allows the user to configure the following options:
?? Review of patient requisitions before printing.
?? Automatic printing of QC and calibration reports.
?? Transmission of reports to a LIMS.
?? The basis for calculating QC cumulative statistics.

1 Select Reporting Options. The Reporting Options form is displayed:

2 Press F2 to display choices (NOT REQUIRED and REQUIRED) for review

of patient reports. Select the choice (using the arrow keys) and press
Enter.

? Note: If YES is selected, patient reports must be reviewed prior to

printing or transmitting to a LIS or LIMS.

3 The MOVING LEVEY-JENNINGS AVERAGE field is selected. Press F2

to display choices (ENABLE and DISABLE) for using the Levey-Jennings
moving average. Select the choice (using the arrow keys) and press
Enter.

? Note: If YES is selected, control results will be compared to a

moving average of actual data after 20 data points have
accumulated. Before that, control results will be compared to the
package insert values.

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4 The BLANK LINE PRINTING field is selected. Press F2 to display

choices (ENABLE and DISABLE) for printing of blank lines. Select the
choice (using the arrow keys) and press Enter.

? Note: If ENABLE is selected, every fifth patient and control result

will be followed by a blank line for easier viewing.
5 The PATIENT REQUISITIONS field of the REPORT PRINTING section is
selected. Press F2 to display choices (ALL, ACE ORIGINATED and
NONE) for automatically printing completed patient requisitions. Select the
choice (using the arrow keys) and press Enter.

? Note: If ALL is selected, all patient requisitions are automatically

printed when they are completed. If ACE ORIGINATED is
selected and the system is interfaced with a bi-directional
laboratory information system, only ACE ORIGINATED patient
requisitions are automatically printed when they are completed. If
NONE is selected, patient requisitions are not automatically
printed when they are completed.

6 The QC REQUISITIONS field of the REPORT PRINTING section is

selected. Press F2 to display choices (ALL, ACE ORIGINATED and
NONE) for automatically printing completed QC requisitions. Select the
choice (using the arrow keys) and press Enter.

? Note: If ALL is selected, all QC requisitions are automatically

printed when they are completed. If ACE ORIGINATED is
selected and the system is interfaced with a bi-directional
laboratory information system, only ACE ORIGINATED QC
requisitions are automatically printed when they are completed. If
NONE is selected, QC requisitions are not automatically printed
when they are completed.
In order to inform the operator that QC results are out of range
before patient samples are run, it is recommended that QC
requisitions be automatically printed when they are completed.

7 The CALIBRATION field of the REPORT PRINTING section is selected.

Press F2 to display choices (ENABLE and DISABLE) for automatically
printing completed calibration requisitions. Select the choice (using the
arrow keys) and press Enter.

? Note: If the ACE Alera System is not interfaced to a laboratory

information management system, proceed to step 10.

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8 The PATIENT REQUISITIONS field of the REPORT TRANSMISSION

section is selected. Press F2 to display choices (ALL, LIMS
ORIGINATED and NONE) for automatically transmitting completed patient
requisitions to the LIMS. Select the choice (using the arrow keys) and
press Enter.

? Note: Report transmission must be enabled if the system

interface with a LIMS is enabled.
If the LIMS interface is not bi-directional, select ALL to
automatically transmit patient requisitions when they are
completed.
If the LIMS interface is bi-directional, select LIMS ORIGINATED
to automatically transmit patient requisitions when they are
completed. This option will transmit only those requisitions that
were downloaded from the LIMS.
If NONE is selected, patient requisitions are not automatically
transmitted to the LIMS when they are completed.

9 The QC REQUISITIONS field of the REPORT TRANSMISSION section is

selected. Press F2 to display choices (ALL, LIMS ORIGINATED and
NONE) for automatically transmitting completed QC requisitions to the
LIMS. Select the choice (using the arrow keys) and press Enter.

? Note: Report transmission must be enabled if the system

interface with a LIMS is enabled.
If the LIMS interface is not bi-directional, select ALL to
automatically transmit QC requisitions when they are completed.
If the LIMS interface is bi-directional, select LIMS ORIGINATED
to automatically transmit QC requisitions when they are
completed. This option will transmit only those requisitions that
were downloaded from the LIMS.
If NONE is selected, QC requisitions are not automatically
transmitted to the LIMS when they are completed.

10 Press F10 to save the selections.

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9.11 Performance Screens

The Performance command displays a menu of diagnostic tools:

These tools are primarily for the use of Alfa Wassermann Diagnostic Technologies, LLC
technical service personnel. Do not use these tools unless directed to do so by an Alfa
Wassermann Diagnostic Technologies, LLC representative.

9.12 Other Options

Selections on the Utilities menu provide access to several other system options.

9.12.1 Set System Date and Time

1 Select Utilities from the Main menu. The Utilities menu is displayed.
2 Select Date/time. The screen displays the message Placing system in
standby…
Then it displays a prompt with the date and time as it is currently entered
in the system:

3 Type the current date and press Enter.

? Note: Use the format selected in Section 9.10.7 on page 220.

4 Type the current time and press Enter.

? Note: Use 24 hour format (e.g., 14:00 for 2:00 pm).

5 Press F10 to save the entries and initialize the system. The Utilities menu
is displayed.

? Note: Press Esc until the Main menu is displayed.

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9.12.2 View Software Version

1 Select Utilities from the Main menu. The Utilities menu is displayed.
2 Select Software. The Software menu is displayed.
3 Select View to display the software version number and the date and time
it was released.
4 Press Esc until the Main menu is displayed.

9.12.3 Set System Language

The user interface text can be displayed in English (default), French, German, Italian or
Spanish.

1 Select Utilities from the Main menu. The Utilities menu is displayed.
2 Select Language. The Select Language screen is displayed.
3 Press F2 at the LANGUAGE: field and select the desired language from
the choice list.

4 Press F10 to save the selection. The system will convert the user interface
to the selected language and return to the Utilities menu.

? Note: In most cases, the error Language cannot be selected.

Files missing. will be displayed on the message line after F10 is
pressed. Contact Technical Service for assistance if the default
language (English) must be changed.

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10 Maintenance

Periodic maintenance procedures must be performed on the ACE Alera System in order
to assure consistent efficient performance or to repair or replace user-serviceable
components.
Certain procedures are to be performed at a specified scheduled frequency whereas
unscheduled maintenance procedures are performed on an as-needed basis.
All maintenance procedures performed on the instrument must be documented in a
maintenance log in order to comply with CLIA 88 requirements.

BIOHAZARD WARNING: Any items exposed to human blood, plasma or

serum must be handled cautiously as a biohazardous material in
accordance with laboratory safety practices and federal and local
regulations. Appropriate personal protective equipment (lab coat, gloves,
eye protection) should be worn when performing maintenance procedures.
Federal, state and local laws and regulations require that hazardous waste
be disposed of in a specific manner. Waste material from the ACE Alera
System which may be classified as biohazardous include used cuvettes,
which are dispensed into the cuvette waste box, used sample cups and
seglets, and waste fluid from the wash bath and ISE which are dispensed
into the system waste container. It is important that steps be taken to
dispose of these materials in accordance with the prevailing regulations in
your location.

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The required preventive maintenance procedures for the system are summarized below:

Frequency Procedure Page

Daily (DM-1) Remove Condensation from Reagent Compartment 229

(DM-2) Clean Wash Bath and Probe Pathway 230

(DM-3) Clean Exterior of Probe 231

(DM-4) Check Probe Alignment 232

(DM-5) Clean and Condition ISE 233

Weekly (WM-1) Clean ISE Reference Housing 234

(WM-2) Clean ISE Sample Port 237

(WM-3) Inspect Air Filters and Clean if Necessary 238

(WM-4) Clean Exterior Surface of Instrument 239

(WM-5) Washplate Assembly Cleaning Procedure 239

Monthly (MM-1) Rinse Probe and Fluid Lines with Bleach 241

(MM-2) Clean Cap Assemblies 242

(MM-3) Calibrate Table Offset, Sample Delay, and Optics 244

Biannual (BM-1) Replace ISE Pump Tubing 245

Unscheduled (UM-1) Replace Printer Paper 247

(As Needed) (UM-2) Replace Printer Ribbon 247

(UM-3) Replace Probe 247

(UM-4) Clean Up Spills 249

(UM-5) Replace ISE Electrodes 250

(UM-6) Replace ISE Peristaltic Pump Roller 252

(UM-7) Replace Tube Piercing Device 253

(UM-8) Replace Printer 254

(UM-9) Long Term ISE Shutdown 255

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10.1 Daily Maintenance

10.1.1 (DM-1) Remove Condensation from Reagent Compartment

Materials Needed: Lint-free cloth

1 Press Fn and F2 to display the Access menu.

2 Select Reagents. The message Preparing for Reagent Access… is
briefly displayed before instructions for loading reagents are displayed.

3 When the access door unlocks, the segment access cover and reagent
cover can be opened.

? Important: Always wait for the access door to be unlocked

before trying to open the segment access cover. Never force the
access door open.

4 If the reagent tray is in the compartment, lift it out and set it aside.
5 Inspect the compartment and camera lenses for condensation. Remove
any moisture using the lint-free cloth (Figure 36).
6 Replace the reagent tray.
7 Close the cover and press F10.
8 Press Esc until the Main menu is displayed.

Recessed Camera
Lenses

Figure 36. Reagent Compartment (Reagent Tray Removed)

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10.1.2 (DM-2) Clean Wash Bath and Probe Pathway

Materials Needed: Cotton tipped applicator sticks

70% (w/v) isopropyl alcohol
Alcohol prep pad

1 Press Fn and F2 to display the Access menu.

2 Select Reagents. The probe will move to the left side of the reagent
compartment.
3 Moisten the cotton tip of an applicator stick with 70% isopropyl alcohol.
4 Clean the entire probe pathway, including the area surrounding each of
the openings.
5 Use an alcohol prep pad to clean the surface of the plate that covers the
wash bath and around the opening in the plate.
6 When the cleaning is completed, press Esc until the Main menu is
displayed.

? Note: The probe will return to its home position over the wash bath.

Figure 37. Probe Pathway

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10.1.3 (DM-3) Clean Exterior of Probe

Materials Needed: Lint-free cloths

Alcohol prep pads
Distilled or deionized water

1 Select Utilities from the Main menu.

2 Select Probe to display the Align Probe screen.
3 Select Position Transfer Arm to ISE Port and press Enter. The probe is
positioned at the ISE port crosshairs.
4 Grasp an alcohol prep pad. Wipe the outside of the probe, starting from
the top of the probe and wiping downwards to the tip, with the alcohol prep
pad until all traces of debris are removed.
5 Moisten a lint-free cloth with distilled or deionized water.
6 Wipe the probe with the moistened lint-free cloth from top to bottom to
remove traces of alcohol.
7 When the cleaning is completed press Enter to reposition the probe at the
crosshairs.
8 Verify that the probe is aligned.
9 Select Test alignment at washbath and verify that the probe is aligned.
10 Press Esc until the Main menu is displayed.

? Note: The probe will return to its home position.

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10.1.4 (DM-4) Check Probe Alignment

Materials Needed: None

1 Select Utilities from the Main menu to display the Utilities menu.
2 Select Probe to display the Align Probe screen.
3 Select Position Transfer Arm to ISE Port and press Enter. The probe is
positioned at the ISE port crosshairs.
4 Examine the position of the probe. If necessary, carefully bend the probe
so that the tip of the probe is positioned at the center of the crosshairs.

? Note: If you need to bend the probe, be sure to press firmly near
the top of the probe.

5 Select Test Alignment at Wash Bath and press Enter. The probe is
positioned at the wash bath and the alignment is automatically checked.

? Note: If the alignment at the wash bath is not within tolerance,

the error –20 probe touched alignment plate unexpectedly is
displayed.

6 Observe the probe during the test. Verify that it is positioned in the middle
of the “U”located on the left side of the alignment plate.

? Note: If necessary, repeat the procedure, starting at Step 3.

Bend the probe in the needed direction, now using the ISE port
crosshairs as a reference.

7 Repeat the alignment and test procedure until the alignment passes.
8 Press Esc until the Main menu is displayed. The system is initialized.

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10.1.5 (DM-5) Clean and Condition ISE

? Note: This procedure must be performed once per shift.

Materials Needed: Sodium Electrode Conditioner

ISE Cleaning Solution
ISE Wash

1 Press Fn and F2 to display the Access menu.

2 Select Reagents. The message Preparing for Reagent Access… is
briefly displayed before instructions for loading reagents are displayed.
3 When the screen display shows that the reagents are available for access,
open the reagent access cover.
4 Place opened containers of ISE Wash, ISE Cleaning Solution, and Sodium
Electrode Conditioner into available positions on the reagent tray.
5 Close the reagent compartment access cover and press F10.
6 Press Esc until the Main menu is displayed.

? Note: The syringe module and ISE modules will be automatically

primed.

7 Select Utilities from the Main menu.

8 Select ISE from the Utilities menu to display the ISE Utilities menu.
9 Select CALIBRATE followed by CONDITION and then CLEAN. A check
mark is displayed next to each selection.
10 Press F10 to initiate the cycles. Messages indicating the status of the
procedure are displayed as the procedure is carried out.
11 Press Esc until the Main menu is displayed.

? Note: Run controls and verify acceptable performance before

reporting ISE results on patient samples.

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10.2 Weekly Maintenance

10.2.1 (WM-1) Clean ISE Reference Housing

Materials Needed: Bleach

Transfer pipets
Distilled or deionized water
Paper towels
ISE transport housing
Forceps or tweezers
Service syringe
Small plastic container
Tape

1 Select Diagnostics from the Main menu to display the Diagnostics menu.
2 Select Troubleshoot to display the Troubleshoot menu.
3 Select ISE. The message Preparing for diagnostics… is displayed
followed by the Troubleshoot ISE menu.
4 Select Operate Valves/Pump to display the ISE Troubleshoot screen.

? Note: Verify that the Enable voltage measurements field is set

to Y, the pump speed is greater than 40 rpm and the pump time
is either 0 or greater than 10 seconds.

5 Open the container access door.

6 Select AIR: and press the spacebar to activate the pump and valve.

7 When the Fluid sensor field on the screen changes from LIQUID to AIR,
wait five seconds and press the spacebar to halt the pump.

? Note: This procedure clears the electrode stack of fluid.

8 Pinch the plastic tabs on either side of the measuring chamber and pull
the chamber forward.
9 Unclamp the electrodes by moving the lever on the left electrode holder
forward.

? Note: To prevent backflow of reference solution, carry out Steps

9 through 13 in the order described.

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10 Remove the reference electrode assembly, being careful to not dislodge

the small black o-rings between the electrodes.
11 Raise the reference electrode assembly above the ISE module.
12 Remove the tubing attached to the fittings on the reference housing.
Secure the tubing to the system above the ISE module using tape.
13 Hold the white collar of the reference housing between your thumb and
index finger. Carefully unscrew the reference electrode and remove it,
placing it on a paper towel.
14 Use a transfer pipette to transfer the reference solution from the reference
housing to the ISE transport housing. Discard any remaining reference
solution into the sink or onto paper towels.
15 Carefully screw the reference electrode into the transport housing and set
it aside.

16 Pour sufficient undiluted household bleach solution into a small plastic

container so that the reference housing will be covered.

? Note: Perform steps 16 through 28 over a sink.

17 Aspirate some undiluted household bleach solution into a transfer pipette.

18 Place the tip of the pipette over the reference housing opening containing
the black o-ring. Squeeze gently to fill the fluid path with bleach. Then, use
the pipette to fill the large opening at the top of the housing with bleach.
19 Submerge the reference housing into the bleach solution and allow it to
soak for 15 minutes.

? Note: Procedure WM-2 (Clean ISE Sample Port) can be

performed while the reference housing is soaking.

20 After 15 minutes, remove the reference housing from the bleach using
forceps or tweezers.
21 Thoroughly rinse reference housing with tap water, following with a final
rinse using distilled or deionized water.
22 Fill the service syringe with distilled or deionized water.
23 Place the service syringe tip in the reference housing opening containing
the black o-ring. Gently push water through the fluid path.

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24 Place your index finger over the opening of the fluid path on the side of the
housing opposite the o-ring. Hold the reference housing with the large
opening pointing downward towards the back wall of the sink.
25 Press the tip of the service syringe into the opening and push the plunger.
A fine stream of water should be visible coming out of the large opening.

? Note: This ensures that the liquid junction capillary is not

clogged.
26 Shake water out of the large opening of the reference housing and pat it
dry using a paper towel.
27 Remove the reference electrode from the transport housing.
28 Holding the white collar of the reference housing between your thumb and
index finger, carefully screw the reference electrode into the reference
housing. Place the assembly into the left side of the measuring chamber.
29 Connect the tubing with the yellow tag to the yellow dotted fitting on the
reference housing. Connect the other tubing to the straight fitting on the
housing.
30 Close the clamp on the chamber by lifting the lever upward until it locks in
place.
31 Slide the measuring chamber backward until it locks completely into
position.
32 Prime the lines by pressing the spacebar after selecting AIR. Verify that
fluid flows through the lines.

? Note: Verify that there is a steady reference solution drip rate of

one drop every 1 to 5 seconds in the reference housing.

33 Wipe up any fluid that may have leaked from the tubing and close the
door.
34 Press Esc until the Main menu is displayed.
35 Select Utilities, then ISE. Select CALIBRATE and WASH PORT.

? Note: If cleaning and conditioning are required, also select

CONDITION and CLEAN

36 Press F10 to start.

37 At the completion of the calibration, press Esc until the Main menu is
displayed.
38 Empty the transport housing, rinse with distilled or deionized water, dry
and store.

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10.2.2 (WM-2) Clean ISE Sample Port

Materials Needed: Bleach

0.5 mL pipet
Distilled or deionized water
Service syringe
Silicon rubber tubing

1 From the Main Menu select Diagnostics

2 Select Troubleshoot then select ISE
3 Select Operate Valves and Pumps
4 Open the container access door. Remove the measuring chamber inlet
tubing from the stainless steel fitting of the ISE manifold. (The fitting is
located on the left side of the ISE manifold facing the electrode holder.)
5 Place a 1-1.5 inch piece of silicon rubber tubing on the stainless steel
fitting. Connect the other end of the tubing to the tip of the service syringe.
6 Pipette 0.5 mL (approximately five drops) of full strength household bleach
solution into the ISE sample port. Allow to soak for three to five minutes.
7 Highlight Sample at the system monitor. Press the Insert key to open the
sample valve.
8 Draw all of the bleach back to the 1mL mark on the service syringe.
9 With the tubing still connected, pipette 0.5 mL (approximately five drops)
distilled or deionized water into the ISE sample port and draw back to the
2 mL mark on the service syringe. Repeat this step by pipetting another
0.5 mL distilled or deionized water into the ISE sample port and drawback
to the 3 mL mark, add another 0.5 mL of distilled or deionized water into
the ISE sample port and draw back to the 4 mL mark on the service syringe.
10 Highlight Sample at the system monitor. Press the Insert key to close the
sample valve.
11 Remove the silicon rubber tubing from the stainless steel fitting.
12 Carefully replace the measuring chamber inlet tubing on the stainless steel
fitting of the ISE sample port.
13 From the Main menu, select Utilities.
14 Select ISE then WASH PORT.
15 Press F10 to start.
16 Press Esc until the Main menu is displayed.

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10.2.3 (WM-3) Inspect Air Filters and Clean if Necessary

Materials Needed: Mild detergent solution

Lint-free cloth

WARNING: The power to the UPS must be OFF before removing and
replacing the filters.

1 With the Main menu displayed, type X to exit DOS, then turn off the power
to the system.
2 Disconnect the analyzer power cord.
3 Remove the air filter under the left side of the analyzer.

? Note: Use your index finger to locate the corner of the filter and
pull it out.

4 Remove the air filter on the right side of the analyzer.

? Note: Open the filter access door, grasp the tab on the filter, and
pull the filter out.

5 Inspect the filters for dust accumulation. If cleaning is required, wash the
filters thoroughly under running tap water, and rinse thoroughly.

? Note: A mild detergent can be used. Dry the filters with a lint-free
cloth before reinstalling. The filters must be completely dry
before they are replaced.

6 Replace the air filter under the left side of the analyzer.

? Note: Hold the filter by the corner with the tab facing towards the
front. Slide the filter into the holder, pushing it in as far as it will
go.

7 Replace the air filter on the right side of the analyzer.

? Note: Open the filter access door, hold the filter by its tab, insert
the filter, and close the filter access door.

8 After both filters have been reinstalled, turn the power on at the UPS.
9 Allow the system to initialize and the temperature to equilibrate.

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10.2.4 (WM-4) Clean Exterior Surface of Instrument

Materials Needed: Mild detergent solution

Lint-free cloth

1 Dampen a cloth with mild detergent solution. Wipe the top, front, and sides
of the analyzer.
2 Dampen a cloth with tap water. Wipe the instrument surface to remove
any detergent.
3 Dry with a lint-free cloth.

10.2.5 (WM-5) Washplate Assembly Cleaning Procedure

Materials Needed: Alcohol prep pad

Distilled or deionized water
Pipette
Flat-blade screwdriver
Sharp blade
Paper clip
Lint-free cloth or gauze pad

Required Time: 10 minutes maximum

1 Press Fn and F2 to display the Access menu. The probe/transfer arm will
move to the far left to allow better access to the touchplate (Figure 38).
2 Select Reagent.
3 Briskly wipe the touchplate with an alcohol prep pad.
4 Use a pipette to place a few drops of distilled or deionized water on the
touchplate. Rub briskly with a gauze pad or lint-free cloth.

Touchplate

Figure 38. Touchplate

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5 Use a flat-blade screwdriver to scrape the top of the touchplate (refer to

Figure 39).
6 Use a sharp blade to scrape the entire inside opening of the touchplate.
Pay particular attention to the rounded sections (refer to Figure 40).
7 Use an unfolded paperclip to scrape the bottom side of the touchplate,
paying particular attention to the rounded sections (refer to Figure 41).
8 Wipe the touchplate with an alcohol prep pad.
9 Press Esc until the Main Menu is displayed. The system will initialize.

Figure 39. Scraping the Touchplate with a Screwdriver

Figure 40. Scraping the Touchplate Opening with a Sharp Blade

Figure 41. Scraping the Touchplate Opening with an Unfolded Paper Clip

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10.3 Monthly Maintenance

10.3.1 (MM-1) Rinse Probe and Fluid Lines with Bleach

Materials Needed: Household bleach solution

Empty system diluent container
Distilled or deionized water

1 Select Diagnostics from the Main menu to display the Diagnostics menu.
2 Select Miscellaneous to display the Miscellaneous menu.
3 Select Prime Syringe to display the Prime Syringe Diagnostic screen is
displayed
4 Select Perform monthly maintenance. The screen displays the first step
of the maintenance routine.
5 Open the container access door.
6 Remove the system diluent container by tilting the bottom of the bottle up
and sliding it out of the compartment.
7 Push the metal release button on the tubing (next to the cap) and then
disconnect the tubing (see Figure 30 on page 96).
8 Remove the cap assembly and set the diluent aside.
9 Prepare approximately 200 mL of a 10% (v/v) solution of household
bleach in distilled or deionized water. Place the solution in an empty
system diluent container and attach the cap assembly.
10 Install the filled system diluent container in the compartment and close the
door.
11 Follow the screen prompts, pressing Enter after completion of each
requested operator action.

? Note: The system automatically primes 10% beach through the

tubing, waits 15 minutes, rinses with water and finally system
diluent.

12 When the maintenance routine is complete, press Esc until the Main menu
is displayed. The system is initialized.

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10.3.2 (MM-2) Clean Cap Assemblies

Materials Needed: Lint-free cloths

Distilled or deionized water

? Note: These cleaning procedures should be performed whenever the

containers of CAL-A, system diluent, CAL-B, and Reference Solution are
replaced or whenever the Waste Container is removed to be emptied.

Biohazard: Waste material from the ACE Alera System which may be
classified as biohahardous includes waste fluid dispensed into the liquid
waste container. Handle cautiously in accordance with laboratory safety rules
and local regulations.

Cleaning the CAL-A, System Diluent, and Waste Cap Assemblies

1 Press Fn and F2 to display the Access menu.

2 Select Container. The message Preparing containers for access… ,
followed by The containers are available for access… is displayed.
3 Remove the cap assemblies.
4 Rinse the cap assemblies with distilled water and remove any crystals that
may have formed.
5 Dry the cap assemblies with a lint-free cloth before placing them on the
appropriate containers.
6 Discard the waste fluid and rinse the waste container as described in
Section 5.5.2.

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Cleaning the CAL-B and Reference Solution Cap Assemblies

Materials Needed: Lint-free cloths

Distilled or deionized water

? Note: Clean one cap at a time beginning with the CAL-B cap assembly. Make
sure that the CAL-B cap assembly is reinstalled on the CAL-B container before
removing the Reference Solution cap assembly, as the CAL-B is easily
contaminated by the Reference Solution.

1 Unscrew the container from the cap assembly and place the container
aside.
2 Using a moistened cloth, remove any crystals that may have formed on
the cap assembly.

? Note: There is a tendency for crystals to form more readily on

the reference solution cap. Be sure to clean it well.

3 Wipe up any crystals that may have fallen into the solutions compartment.
4 Install new container of CAL-B.
5 Repeat with Reference Solution as described in Section 5.5.

? Note: When all containers have been installed, close the

compartment door and press F10.

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10.3.3 (MM-3) Calibrate Table Offset, Sample Delay, and Optics

Materials Needed: None

1 Select Diagnostics from the Main menu to display the Diagnostics menu.
2 Select Hardware Calibration to display the Hardware Calibration menu.
3 Select Analyzer to display the Analyzer menu.
4 Select Table offset. A series of messages is displayed and the table
offset calibration procedure begins.
5 At the completion of the table offset calibration, the Analyzer Hardware
Calibration menu is displayed.
6 Select Sample delay and optics. A series of messages is displayed.
7 At the completion of the optical calibration, the Analyzer Hardware
Calibration menu is again displayed.
8 Press Esc until the Main menu is displayed. The system is initialized.

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10.4 Bi-Annual Maintenance

10.4.1 (BM-1) Replace ISE Pump Tubing

Materials Needed: New peristaltic pump tubing

Replacing Pump Tubing

1 Select Diagnostics from the Main menu. The system is halted.

2 Select Troubleshoot then ISE from the Diagnostics menu.
3 Select Operate Valves/Pump.
4 Open the container access door.
5 Disengage the pump loops from around the pump roller and slide the
plastic pump plate from its support. Disconnect one pump tube at a time
from the top of the old pump plate and reconnect it to the same positions
on the new plate.

? Note: The smaller (narrower) end of the pump plate is closest to

the rear of the ISE module.
6 Slide the new plate into its support and stretch the tubing back over the
rollers.

? Note: The tubes must be positioned parallel to each other.

They should never cross.
7 Wipe up any spills.

Checking the Installation of New Pump Tubing

1 Select Troubleshoot then ISE from the Diagnostics menu.

2 Select Operate Valves/Pump from the Troubleshoot ISE menu.
3 Select AIR: then press the spacebar to operate the pump and valve.
4 The entry in the Fluid Sensor field should change from Liquid to Air.
5 Verify that air and reference solution flows back into the reference solution
container.
6 Press the spacebar to stop the pump.
7 Select CAL-A then press the spacebar to operate the pump.
8 The entry in the Fluid Sensor field should change from AIR to LIQUID.

9 Press the spacebar to stop the pump.

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10 Check for fluid leaks below the peristaltic pump and around the fittings.
11 Close the compartment door.
12 Press Esc to display the Troubleshoot ISE menu.
13 Select Prime to calibrate the peristaltic pump speed to the new pump
tubing.
14 Press Esc until the Main menu is displayed. The system is initialized.

? Note: It is recommended to calibrate the ISE liquid sensor after

replacing the pump tubing. Refer to Section 4.5.5 on page 75.

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10.5 Unscheduled Maintenance

10.5.1 (UM-1) Replace Printer Paper

Refer to the instructions found in the manual supplied with the printer.

10.5.2 (UM-2) Replace Printer Toner Cartridge and Drum

The LED indicator light illuminates when the toner is low. The printer will print
approximately 100 more pages before running out of toner. The toner cartridge needs to
be replaced every 2,500 pages. The drum needs to be replaced every 25,000 pages.

Refer to the instructions found in the manual supplied with the printer.

10.5.3 (UM-3) Replace Probe

Materials Needed: New probe

Allen wrench (provided)

WARNING: The power to the system must be OFF before removing and
replacing the probe.

1 Verify that the fluid arm is in the full up position.

2 With the Main menu displayed, type X to exit DOS, then turn off the power
to the system at the UPS.
3 Gently move the fluid arm assembly to a position midway through the
probe pathway, away from the ports.
4 Using the Allen wrench provided, loosen the captive screw on the top of
the fluid arm assembly cover by turning it counter-clockwise. Lift the cover
off and set it aside.
5 Carefully loosen the two captive Allen screws holding the probe to the fluid
arm assembly. Loosen each screw one turn at a time, alternating between
the screws so that the two screws are backed out together. Continue
alternately loosening each screw one turn at a time until the probe stem is
completely removed from the fluid arm assembly tubing.
6 Grasp the black bracket at the top of the probe. Remove the probe by
carefully pulling it out and away from the arm.

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7 Obtain a new probe.

8 Slide the end of the Allen screws back so they are even with the o-rings.

9 Grasp the black bracket at the top of the new probe and slide the probe
stem into the Teflon tube opening (at the center of the end of the fluid arm
assembly), taking care to avoid contact with the flared sealing surface.
10 Push the probe stem in as far as it will go. Hold it in place while tightening
the Allen screws in the following step.

? Note: Be sure to push the probe stem as far forward as it will go.
The level sensing contact at the top of the probe must touch the
level sensing contact of the fluid arm assembly PC board.

11 Tighten each Allen screw one turn at a time, alternating between the
screws so that the two screws are tightened together. Continue alternately
tightening each screw one turn at a time until the probe stem is snug.
Then, turn each Allen screw an additional 1/8 turn clockwise.

? Note: Do not over tighten.

12 Place the cover on the fluid arm assembly. Tighten the Allen screw by
turning it clockwise.
13 Make sure the fluid arm assembly is pushed down so that the probe tip
just misses the top of the main deck.
14 Turn the power on at the UPS.
15 Allow the system to initialize. When the Main menu is displayed, align the
probe. Refer to Section 10.1.4 on page 232 for details.

Fluid Arm Probe

Assembly Assembly

Figure 42. Installation of Probe Assembly

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10.5.4 (UM-4) Clean Up Spills

Materials Needed: Disposable towels

Household bleach
Mild detergent solution

Cleaning Spills of Blood or Other Potentially Infectious Fluids

Biohazard: Any item exposed to human blood, plasma or serum

must be handled cautiously as a biohazardous material in
accordance with laboratory safety practices and federal and local
regulations. Appropriate personal protective equipment (lab coat,
gloves, eye protection) should be worn when cleaning up spills.

1 Remove visible material with a disposable towel.

2 Decontaminate the area with a disposable towel dampened with bleach
solution.
3 Wipe the decontaminated area with a disposable towel and water.
4 Dispose of the cleaning materials as a biohazardous waste in accordance
with laboratory safety practices and local regulations.

Cleaning Reagent Spills

1 Wipe up the spill with a disposable towel.

2 Clean the area with a disposable towel dampened with detergent solution.
3 Wipe the area again with a towel moistened with water to remove the
detergent.
4 Wipe the area with a disposable towel to dry.

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10.5.5 (UM-5) Replace ISE Electrodes

Materials Needed: Replacement Electrodes

1 Select Diagnostics from the Main menu to display the Diagnostics menu.
2 Select Troubleshoot to display the Troubleshoot menu.
3 Select ISE. The message Preparing for diagnostics… is displayed
followed by the Troubleshoot ISE menu.
4 Select Operate Valves/Pump to display the ISE Troubleshoot screen.

? Note: Verify that the Enable voltage measurements field is set

to Y, the pump speed is greater than 40 rpm and the pump time
is either 0 or greater than 10 seconds.

5 Open the container access door.

6 Select AIR: and press the spacebar to activate the pump and valve.
7 When the Fluid sensor field on the screen changes from LIQUID to AIR,
wait five seconds and press the spacebar to halt the pump.

? Note: This procedure clears the electrode stack of fluid.

8 Pinch the plastic tabs on either side of the measuring chamber and pull
the chamber forward.
9 Unclamp the electrodes by moving the lever forward on the left electrode
holder.
10 Carefully remove the electrode to be replaced from the measuring
chamber taking care not to dislodge the small, black o-rings between the
electrodes and in the electrode holder.
11 Remove the new electrode from its box and check for the presence of an
o-ring in the left side of the electrode.
12 Install the new electrode in its labeled position in the Measuring Chamber.

? Note: Be sure the lip on the bottom of the electrode rests on the
flat edge of the measuring chamber to aid in proper positioning.

13 Be sure that the electrodes are seated properly.

? Note: Use the fingers of your right hand to hold the electrodes in
place.

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14 Close the clamp on the left electrode holder by lifting the lever upward until
it locks in the back position.
15 Slide the measuring chamber backward until it locks completely into
position.
16 Select CAL-A: and press the spacebar.
17 Verify that fluid moves into the chamber.
18 If it does not, reseat the electrodes.
19 When the Fluid sensor field changes from AIR to LIQUID, wait five
seconds and press the spacebar to halt the pump.
20 Close the container access door.
21 Press Esc until the Main menu is displayed. The system is initialized.

? Note: After replacing the sodium, potassium, or chloride

electrode, cleaning, conditioning and calibration must be
performed (refer to Section 10.1.5 on page 233).

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10.5.6 (UM-6) Replace ISE Peristaltic Pump Roller

Materials Needed: New peristaltic pump roller

1 Select Diagnostics from the Main menu to display the Diagnostics menu.
2 Select Troubleshoot to display the Troubleshoot menu.
3 Select ISE. The message Preparing for diagnostics… is displayed
followed by the Troubleshoot ISE menu.
4 Open the container access door.
5 Carefully slide the pump tubing from the pump roller and slide the plastic
pump plate from its support.
6 Grasp the pump roller firmly and pull it forward to remove it from the shaft.
7 Obtain the new pump roller. Push it onto the shaft.

? Note: The pump roller is keyed to fit the shape of the shaft. It will
only slide on one way.

8 Slide the pump plate back onto its support. Stretch the tubing over the
rollers, making sure that the pump tubes are parallel to each other and do
not cross.
9 Check the installation of pump tubing as outlined in Section 10.4.1 on
page 245.

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10.5.7 (UM-7) Replace Tube Piercing Device

Materials Needed: Flat blade screwdriver

Replacement tube piercing device

WARNING: Biohazard. Sharp. The used tube piercing device must be

handled as a biohazardous material and as a sharp. Handle with
extreme care. Dispose of in accordance with laboratory safety procedures
and local regulations.

1 Select Diagnostics from the Main menu to display the Diagnostics menu.
2 Select Troubleshoot to display the Troubleshoot menu.
3 Select Tube entry to display the Tube Entry menu.
4 Select Move Motors to display the STEP Motors menu.
5 Select Close Door to close the STEP Door.
6 Remove the STEP door cover.

? Note: Remove the STEP door cover by pushing down at the rear
of the door to push the front of the door up. The door is held in
place by magnets, and it can now be removed by grasping the
front end and lifting it out.

7 Remove the two screws holding the tube piercing device.

? Note: Use a flat blade screwdriver and turn the screws counter-
clockwise to remove them.

8 Use the blade of the screwdriver to lift the tube piercing device slightly.
9 Turn the tube piercing device so that it clears the analyzer cover. Remove
it from the STEP.
10 Install the replacement tube piercing device, holding it by the flat mounting
bracket on the top and with the bevel edge facing away from the operator.
11 Turn the replacement tube piercing device slightly to clear the analyzer
cover. Avoid touching the sharp piercing tip.
12 Secure the replacement tube piercing device with the two screws.
13 Replace the STEP Door cover. Verify that the STEP door cover is
centered and that it is properly seated.

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14 Check operation of the STEP door by selecting Open Door, Close Door
and Open Door.

? Note: If the STEP door does not open and close smoothly,
remove the cover, loosen the screws to the door and center it.

15 Check operation of the piercing device by inserting a tube with a stopper

into the STEP and selecting Get Tube. After the door closes and the tube
is pierced, select Return Tube to return the tube.

? Note: If the piercing device does not operate properly, repeat the
entire procedure, checking that the piercing device is secured
properly. Contact your Alfa Wassermann Diagnostic
Technologies, LLC technical representative for assistance.

16 Select Home All Motors.

17 Press Esc until the Main menu is displayed.

10.5.8 (UM-8) Replace Printer

Follow the setup instructions provided with the printer.

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10.5.9 (UM-9) Long Term ISE Shutdown

Power to the analyzer should remain ON at all times.

If the analyzer power is shut OFF for an extended period of time, the ISE module must
be prepared for shutdown as described below.

CAUTION: Failure to follow the ISE shutdown procedure when turning the
analyzer power OFF for an extended period of time can result in damage
to the electrodes, reference housing and tubing.

Materials Needed: Soft cloth or towel

ISE transport housing
Boxes for storing electrodes
Parafilm
Empty CAL-A container
Empty CAL-B container
Empty Reference Solution container
Distilled or deionized water
Transfer pipet
Dummy electrode

1 From the Main menu select Diagnostics, then Miscellaneous.

2 Select Drain ISE. Instructions are displayed for removal of the ISE
containers.
3 Remove the CAL-A container. Remove the CAL-A cap assembly from the
container, and cap the container using an extra CAL-A container cap.

? Note: Follow the instructions on the screen when removing the

ISE containers.
Parafilm may be used to cap the container if an extra CAL-A
container cap is not available.

4 Remove the CAL-B container. Remove the CAL-B cap assembly from the
container, and cap the container using an extra CAL-B (red) container cap.

? Note: Parafilm may be used to cap the container if an extra CAL-

B container cap is not available.

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5 Install an empty CAL-B container on the analyzer. Cap it using the CAL-B
(red) cap assembly.
6 Remove the Reference Solution container and remove the Reference
Solution cap assembly. Cap the container using an extra Reference
Solution (white) container cap.

? Note: Parafilm may be used to cap the container if an extra

Reference Solution container cap is not available.

7 Install an empty Reference Solution container on the analyzer. Cap it

using the Reference Solution (white) cap assembly.

8 Press F10 to drain the ISE system. When drainage is complete, the
Miscellaneous menu is displayed.
9 Fill an empty CAL-A container with distilled or deionized water and cap it
using the CAL-A cap assembly. Place the filled and capped CAL-A
container on the analyzer.
10 Remove the CAL-B container and discard any drained fluids. Fill the
CAL-B container with distilled or deionized water and place it on the
analyzer. Cap the container using the CAL-B cap assembly.
11 Remove the Reference Solution container and discard any drained fluids.
Fill the Reference Solution container with distilled or deionized water and
place it on the analyzer. Cap the container using the Reference Solution
cap assembly.
12 Pinch the plastic tabs on either side of the measuring chamber and pull
the chamber forward.
13 Unclamp the electrodes by moving the lever forward on the left electrode
holder and carefully remove the reference housing, taking care not to
dislodge the small black o-rings between the electrodes and the right
electrode holder.
14 Holding the white collar between thumb and index finger, carefully
unscrew the reference electrode from the housing and temporarily place it
on a clean, soft cloth or towel.
15 Use a transfer pipette to transfer the reference solution from the reference
housing to the ISE transport housing.
16 Screw the reference electrode into the ISE transport housing. Carefully
screw the ISE transport housing into the reference housing. Allow the
reference housing to rest in front of the module on a soft cloth or towel.
17 Check that there is an o-ring present on the left side of the dummy
electrode.

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18 Taking care not to dislodge the o-ring, install the dummy electrode in the
measuring chamber next to the left electrode holder.
19 Making sure that the electrodes are seated properly, close the electrode
holder by lifting the lever upward until it locks in the back position.
20 Select Prime ISE to prime ISE module with water.
21 When the prime cycle is complete, select Prime ISE a second time.
22 When the second prime is complete, remove the containers of water from
the CAL-A and CAL-B positions and replace them with empty containers.

? Note: The empty containers protect the CAL-A and CAL-B

aspiration tubing from contamination and help position the system
diluent container.

23 Remove the Reference Solution (white) cap assembly from the Reference
Solution container. Empty the container and then place it under the
Reference Solution (white) cap assembly to catch water as it is draining.

? Note: Rest the white cap assembly on the container but do not
tighten the cap, as this will cause the tubing to fill with water
instead of air.

24 Select Drain ISE and then press F10 to drain the water from the ISE.
25 When complete, select Drain ISE a second time.
26 When the second drain cycle is complete, carefully unscrew the ISE
transport housing with the reference electrode from the reference
electrode housing. Place the ISE transport housing and electrode in the
storage box.
27 Clean the reference housing.

? Note: Follow Steps 16 through 26 of the procedure starting on

page 233.

28 The reference housing and the sodium, potassium and chloride electrodes
may either be left in the measuring chamber or removed and placed in
their storage boxes. If the electrodes are removed, be sure that the o-ring
seal for each electrode is present.
29 Wipe up any spills in the ISE module.
30 Slide the peristaltic pump tubing off of the rollers.

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31 Remove the sample, CAL-A, CAL-B and Air Intake tubes from the pinch
valves.
32 Close the container access door.
33 Press Esc until the Main menu is displayed.
34 Select Setup to display the Setup menu.

? Note: It may be necessary to enter a password to access the

Setup menu.

35 Select Hardware to display the Setup Hardware Configuration screen.

36 At the ISE ENABLE: field, select NO to disable the ISE.
37 Press F10.
38 Press Esc until the Main menu is displayed.

? Note: To restart the ISE after a long term shutdown, refer to

Section 4.5.2 on page 58 for instructions regarding installation of
tubing, electrodes and reagents and Section 9.1.1 on page 181
for instructions on how to enable the ISE and select the
calibration mode. Once the ISE is reinstalled, perform ISE
weekly maintenance procedures.

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Index
abort run, 149 cleaning and conditioning, 75
accession enabling, 181
mode, 220 installing tubing, 58
number, 109 maintainance, 233
alarm volume, 186 setting calibration mode, 182
analysis module, 4 setup, 58
analysis sequence, 37 ISE module, 11
analyzer state, 30 label symbology, 188
archiving mode, 220 LIMS, 183, 184, 190
backup system, 169 line conditioner, 3
calibration, 37 loadlist
calibration requisitions, 120 description, 24
calibrators, 15 maintenance
carryover parameters, 214 daily start up, 77, 229
controls, 15, 140 monthly, 242
correlation, 46, 145 weekly, 234
cup segment menus
description, 14 access, 29
loading, 90 journals, 24
curve correction, 39 main, 21
cuvette cartridge, 12 navigating, 20
cuvette hopper purge, 25
description, 8 reports, 23
loading, 86 requisitions, 22
cuvette waste box, 101 selecting a command, 20
cuvettes, 12 setup, 27
data management, 151 status, 28
date format, 220 utilities, 25
delete modules
patient, 179 analysis, 4
patient requisition, 178 ISE, 11
test, 114 sample/reagent, 5
dilution syringe, 6
auto, 46 monitor, 19
ratios, 193 motors, 10
dimensions, 54 operational precautions, 48
doctor list, 213 optical system, 8
electrical service, 55 panels, 211
electrodes password, 215
description, 11 patient requisition
installing, 71 creating, 103
equations, 41 deleting, 178
error messages, 148 merged, 156
flags, 44 modifying, 114, 115
fluid transport system, 4 ordering tests, 109
function keys, 17 printing archived, 174
hopper, 8 reviewing, 158
instrument access, 29 precision data, 141
ISE priority, 36

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purging test counts, 176 sample cups

QC requisitions, 117 description, 14
Quality Control placement options, 128
checks, 197 sample tube entry port, 6
corrective actions, 141 seglet, 13
cumulative statistics, 162 shutdown, 150
Levey-Jennings plots, 160 software
parameters, 203, 205 installation, 56
reminder, 215 version, 30, 225
reaction wheel, 8 solutions
reagents replacing, 95, 101
description, 15 specifications, 31
ISE, 16, 73 status checks
loading, 93 calibration, 80
preparing, 92 cuvette hopper, 84
references ranges, 196 database, 85
reporting options, 221 reagent tray, 78
reports sample ring, 82
backlog, 153, 163 tests on-hold, 81
calibration, 165 STEP, 6
calibration data, 153 syringe module, 6
journal, 153, 168 system backup, 169
Levey-Jennings, 160 system overview, 1
merged, 156 system sensors, 9
patient, 151, 154 system setup, 51
performance, 153, 167 temperature
QC, 152, 159 control system, 7
QC statistics, 162 reagent temperature control, 185, 190
raw data, 153, 165 tests
test counts, 153, 164 calculation, 201
test parameters, 153, 166 creating, 198
transmitting to LIMS, 223 customizing parameters, 191
requisitions derived, 200
calibration, 120 manual rerun, 130
correction, 122 off-line, 199
multiple, 107 ordering, 103
patient, 103 panels, 211
QC, 117 remote, 113, 201
restoring system data, 170, 172 running, 125
results stopping, 149
calculation, 40 UPS, 11
calibration, 136 user access, 30
editing, 139 well segments
off-line, 138 description, 13
patient, 134 loading, 88
QC, 135 removing, 150
verifying, 137 workstation, 17
RTI mode, 133

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