ACE Operator Manual Rev 6-04

P/N 701164 Rev 6/04

ACE® Clinical Chemistry System

Operator’s Manual

ii P/N 701164 Rev 6/04

Revision History

Manual Version Revision Date

1.0 February 2003

1.1 August 2003

1.2 June 2004

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

Copyright and Trademarks

Copyright© 2003 and 2004, Alfa Wassermann Diagnostic Technologies, LLC. All rights reserved. This material may not be reproduced or copied, in whole or in part, without the written permission of Alfa Wassermann Diagnostic Technologies, LLC.

ACE® is a registered trademark of Alfa Wassermann Diagnostic Technologies, LLC.

GEMCAL™ is a trademark of Alfa Wassermann Diagnostic Technologies, LLC.

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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

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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 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.

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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 Indicator Panel ................................................................................... 7 2.1.7 Reaction Wheel ................................................................................. 8 2.1.8 Cuvette Hopper.................................................................................. 8 2.1.9 Optical System................................................................................... 8 2.1.10 Liquid Level Sensing System........................................................... 9 2.1.11 System Sensors............................................................................... 9 2.1.12 CPU Interface Board........................................................................ 9 2.1.13 Motors ............................................................................................ 10 2.1.14 ISE Module (Optional).................................................................... 11

2.2 Uninteruptible Power Supply ....................................................................... 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 Computer Workstation ................................................................................. 17 2.5.1 Computer ......................................................................................... 17 2.5.2 Keyboard ......................................................................................... 17 2.5.3 Printer .............................................................................................. 18 2.5.4 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 Loadlist ............................................................................................ 24 2.6.7 Journals ........................................................................................... 24 2.6.8 Purge ............................................................................................... 25

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2.6.9 Utilities..............................................................................................25 2.6.10 Diagnostics.....................................................................................26 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..................................................................................................... 50 4.1 Materials.......................................................................................................50

4.1.1 Materials Provided............................................................................50 4.1.2 ISE Parts ..........................................................................................51 4.1.3 Materials Required but Not Provided................................................51

4.2 Positioning and Connecting the Modules .....................................................52 4.2.1 Site Selection ...................................................................................52 4.2.2 Physical Dimensions and Space Requirements...............................53 4.2.3 Electrical Service..............................................................................54 4.2.4 Positioning of Modules .....................................................................54 4.2.5 Connecting the Modules...................................................................54

4.3 Software Installation .....................................................................................55 4.3.1 Re-Loading the Operating Software .................................................55 4.3.2 Re-Loading the Setup Information....................................................56 4.3.3 Setting the Printer Parameters .........................................................56

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4.4 Container Installation ................................................................................... 57 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 ............................................................76 5.1 Daily Maintenance ....................................................................................... 76 5.2 Checking Status........................................................................................... 77

5.2.1 Power............................................................................................... 77 5.2.2 Checking Reagent Tray Status ........................................................ 77 5.2.3 Checking Calibration Status............................................................. 79 5.2.4 Checking Tests On Hold .................................................................. 80 5.2.5 Checking Sample Ring Status ......................................................... 81 5.2.6 Checking Hopper Status.................................................................. 83 5.2.7 Checking Database Status .............................................................. 84

5.3 Loading Consumables ................................................................................. 85 5.3.1 Loading the Cuvette Hopper ............................................................ 85 5.3.2 Loading Clean Well Segments......................................................... 87 5.3.3 Loading Empty Cup Segments ........................................................ 89

5.4 Loading Reagents........................................................................................ 91 5.4.1 Preparing Reagents ......................................................................... 91 5.4.2 Loading Reagents............................................................................ 92

5.5 Replenishing Solutions ................................................................................ 94 5.5.1 Accessing Solution Containers ........................................................ 94 5.5.2 Emptying System Waste.................................................................. 94 5.5.3 Replacing System Diluent................................................................ 95 5.5.4 Replacing ISE CAL-A....................................................................... 95 5.5.5 Replacing ISE CAL-B....................................................................... 96 5.5.6 Replacing ISE Reference Solution................................................... 97

5.6 Emptying the Cuvette Waste Box ................................................................ 98

6 ORDERING TESTS .................................................................................................99 6.1 Initiating a Patient Sample Requisition ........................................................ 99

6.1.1 Initiating a Requisition for a New Patient ....................................... 100 6.1.2 Initiating a Requisition for an Existing Patient................................ 102 6.1.3 Initiating Multiple Requisitions........................................................ 103

6.2 Ordering Tests for Patient Sample Requisitions........................................ 105 6.2.1 Ordering Tests for a New Patient................................................... 105 6.2.2 Adding One or More Tests to an Existing Requisition ................... 107 6.2.3 Ordering a Remote (Linking) Test.................................................. 109

6.3 Modifying a Patient Requisition ................................................................. 110 6.3.1 Deleting a Test From a Requisition................................................ 110 6.3.2 Changing Information in a Requisition ........................................... 111

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6.4 Creating a QC Requisition..........................................................................113 6.4.1 Selecting a Control Requisition ......................................................113 6.4.2 Ordering a Rerun of All Tests .........................................................114 6.4.3 Ordering a Rerun of a Single Test..................................................114 6.4.4 Deleting all Current Tests ...............................................................114 6.4.5 Ordering One or More New Tests ..................................................115

6.5 Creating a Calibration Requisition..............................................................116 6.5.1 Initiating a Calibrator Requisition....................................................116 6.5.2 Initiating a Correction Requisition...................................................118

7 RUNNING TESTS ................................................................................................. 120 7.1 Running a Single Sample...........................................................................120

7.1.1 Running a Tube with a Barcode Label ...........................................120 7.1.2 Running a Tube without a Barcode Label ......................................121 7.1.3 Running an Individual Sample Cup ................................................122 7.1.4 Refilling a Short Sample Cup .........................................................123 7.1.5 Replacing an Expired Sample Cup.................................................123 7.1.6 Removing an Inactive Sample Cup ................................................124 7.1.7 Manual Rerun of Tests ...................................................................125

7.2 Running a Batch of Samples......................................................................126 7.2.1 Running a Batch of Sample Cups ..................................................126 7.2.2 Running a Batch of Sample Tubes.................................................128

7.3 Results .......................................................................................................129 7.3.1 Patient Results ...............................................................................129 7.3.2 Quality Control Results...................................................................130 7.3.3 Calibration Report...........................................................................131 7.3.4 Verifying Results ............................................................................132 7.3.5 Entering Off-Line Results ...............................................................133 7.3.6 Entering Calculation Test Values ...................................................133 7.3.7 Editing Results................................................................................134

7.4 Quality Assurance ......................................................................................135 7.4.1 Use of Quality Control Material.......................................................135 7.4.2 Corrective Action ............................................................................136 7.4.3 Precision Data ................................................................................136 7.4.4 Correlation Data .............................................................................140

7.5 Messages During the Run..........................................................................143 7.6 Stopping the Run........................................................................................144 7.7 Daily Shutdown ..........................................................................................145

7.7.1 Check Fluid Levels .........................................................................145 7.7.2 Remove Used Sample Cups and Seglets ......................................145 7.7.3 Backup System ..............................................................................145

7.8 Powering Off the System............................................................................145

8 DATA MANAGEMENT ......................................................................................... 146 8.1 Types of Reports ........................................................................................146

8.1.1 Patient Reports...............................................................................146 8.1.2 QC Reports ....................................................................................147 8.1.3 Other Reports .................................................................................148

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8.2 Preparing a Patient Report ........................................................................ 149 8.2.1 Single Requisition .......................................................................... 149 8.2.2 Cumulative Report ......................................................................... 150 8.2.3 Merged Report ............................................................................... 151 8.2.4 Archived......................................................................................... 152 8.2.5 Review of Patient Reports ............................................................. 153

8.3 Preparing a QC Report .............................................................................. 154 8.3.1 Requisition ..................................................................................... 154 8.3.2 Monthly Levey-Jennings Plots ....................................................... 155 8.3.3 Individual Levey-Jennings Plots..................................................... 156 8.3.4 Including More Information in Individual Levey-Jennings Plots ..... 156 8.3.5 QC Statistics .................................................................................. 157

8.4 Preparing Other Reports............................................................................ 158 8.4.1 Backlog Report .............................................................................. 158 8.4.2 Test Counts Report........................................................................ 159 8.4.3 Calibration Report .......................................................................... 160 8.4.4 Raw Data Report ........................................................................... 160 8.4.5 Parameters Report......................................................................... 161 8.4.6 Performance Report....................................................................... 162 8.4.7 Journal Report ............................................................................... 163

8.5 System Backup and Restoration ............................................................... 164 8.5.1 System Backup.............................................................................. 164 8.5.2 Restoring System Data .................................................................. 165

8.6 Archiving and Purging Patient Files........................................................... 166 8.6.1 Purging Inactive Files without Archiving ........................................ 166 8.6.2 Archiving and Purging Inactive Files.............................................. 167 8.6.3 Restoring the Archive Log.............................................................. 168 8.6.4 Displaying or Printing an Archived Patient Requisition .................. 169

8.7 Deleting Patient Data................................................................................. 170 8.7.1 Deleting a Test............................................................................... 170 8.7.2 Deleting a Requisition.................................................................... 170 8.7.3 Deleting a Patient........................................................................... 171

8.8 Purging Test Counts .................................................................................. 172 8.8.1 Resetting All Counts ...................................................................... 172 8.8.2 Resetting Individual Counts ........................................................... 173

9 CONFIGURATION.................................................................................................174 9.1 Hardware Setup......................................................................................... 174

9.1.1 Enabling the ISE Module ............................................................... 174 9.1.2 Setting the ISE Calibration Mode................................................... 175 9.1.3 Enabling the Laboratory Information Management System (LIMS)176 9.1.4 Specifying Entry of Patient First Name .......................................... 177 9.1.5 Disabling Reagent Temperature Control ....................................... 178 9.1.6 Adjusting the Volume of the Audible Alarm.................................... 179 9.1.7 Specifying the Type of Barcode Scanner....................................... 180 9.1.8 Specifying Label Symbology.......................................................180-a 9.1.9 Specifying Sample Lifetime.........................................................180-b 9.1.10 Specifying Suppression of Leading Zeros in the Accession ....... 180-c

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9.2 Test Parameters.........................................................................................181 9.2.1 Modifying a Test Name or Mnemonic.............................................182 9.2.2 Modifying Predilution or Auto Rerun Dilution Ratios.......................183 9.2.3 Modifying Calculation Method Parameters.....................................184 9.2.4 Modifying the Result Units or Decimal Places................................185 9.2.5 Modifying Reference Ranges .........................................................186 9.2.6 Enabling or Disabling Quality Control Checks................................187 9.2.7 Creating a New Test.......................................................................188

9.3 Special Tests..............................................................................................189 9.3.1 Off-Line Test...................................................................................189 9.3.2 Derived Test ..............................................................................190 9.3.3 Calculation Test...........................................................................191 9.3.4 Remote Test ...................................................................................191

9.4 Calibrators ..................................................................................................193 9.4.1 Defining Calibrators........................................................................193 9.4.2 Modifying Information for a Calibrator ............................................193 9.4.3 Deleting a Calibrator.......................................................................194

9.5 Controls ......................................................................................................195 9.5.1 Defining a New Control...................................................................195 9.5.2 Modifying Expected Values for a Control .......................................196 9.5.3 Modifying the Lot Number for a Control..........................................197 9.5.4 Deleting a Control...........................................................................198

9.6 User-Defined Reagent Bottles....................................................................199 9.7 Configuring Test Panels .............................................................................201

9.7.1 Defining a Panel .............................................................................201 9.7.2 Modifying a Panel ...........................................................................202 9.7.3 Deleting a Panel .............................................................................202

9.8 Configuring the Doctor List.........................................................................203 9.8.1 Adding a Doctor’s Name.................................................................203 9.8.2 Modifying a Doctor’s Name ............................................................203 9.8.3 Deleting a Doctor’s Name...............................................................203

9.9 Configuring Carryover Parameters.............................................................204 9.9.1 Specifying a Probe Rinse ...............................................................204

9.10 Miscellaneous Options ...............................................................................205 9.10.1 Displaying Miscellaneous Options................................................205 9.10.2 Password......................................................................................206 9.10.3 QC Reminder ...............................................................................207 9.10.4 Facility Identification .....................................................................207 9.10.5 Report Footer ...............................................................................208 9.10.6 Archiving Mode.............................................................................208 9.10.7 Setting the Date Format ...............................................................208 9.10.8 Setting the Accession Mode.........................................................209 9.10.9 Reporting Options.........................................................................210

9.11 Performance Screens.................................................................................213 9.12 Other Options .............................................................................................213

9.12.1 Set System Date and Time...........................................................213 9.12.2 View Software Version .................................................................214 9.12.3 Set System Language ..................................................................214

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10 MAINTENANCE ....................................................................................................215 10.1 Daily Maintenance ..................................................................................... 217

10.1.1 (DM-1) Remove Condensation from Reagent Compartment...... 217 10.1.2 (DM-2) Clean Wash Bath and Probe Pathway ............................ 218 10.1.3 (DM-3) Clean Exterior of Probe ................................................... 219 10.1.4 (DM-4) Check Probe Alignment ................................................... 220 10.1.5 (DM-5) Clean and Condition ISE ................................................. 221

10.2 Weekly Maintenance ................................................................................. 222 10.2.1 (WM-1) Clean ISE Reference Housing ........................................ 222 10.2.2 (WM-2) Clean ISE Sample Port ................................................... 225 10.2.3 (WM-3) Inspect Air Filters and Clean if Necessary ...................... 226 10.2.4 (WM-4) Clean Exterior Surface of Instrument.............................. 227

10.3 Monthly Maintenance................................................................................. 229 10.3.1 (MM-1) Rinse Probe and Fluid Lines with Bleach........................ 229 10.3.2 (MM-2) Clean Cap Assemblies and Connectors.......................... 230 10.3.3 (MM-3) Calibrate Table Offset, Sample Delay, and Optics.......... 232

10.4 Bi-Annual Maintenance.............................................................................. 233 10.4.1 (BM-1) Replace ISE Pump Tubing............................................... 233

10.5 Unscheduled Maintenance ........................................................................ 235 10.5.1 (UM-1) Replace Printer Paper ..................................................... 235 10.5.2 (UM-2) Replace Printer Ribbon.................................................... 235 10.5.3 (UM-3) Replace Probe................................................................. 235 10.5.4 (UM-4) Clean Up Spills ................................................................ 237 10.5.5 (UM-5) Replace ISE Electrodes................................................... 238 10.5.6 (UM-6) Replace ISE Peristaltic Pump Roller ............................... 240 10.5.7 (UM-7) Replace Fuse................................................................... 241 10.5.8 (UM-8) Replace Tube Piercing Device ........................................ 242 10.5.9 (UM-9) Replace Printer ................................................................ 243 10.5.10 (UM-10) Long Term ISE Shutdown.............................................. 244

11 TROUBLESHOOTING PROCEDURES ................................................................249 11.1 System Error Messages ............................................................................ 249

11.1.1 Responding to a System Error Message ..................................... 250 11.1.2 Summary of System Error Messages and Their Resolution ........ 251

11.2 System Operation Troubleshooting ........................................................... 263 11.3 Workstation Troubleshooting ..................................................................... 267 11.4 System Power Failure................................................................................ 267

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11.5 Advanced Troubleshooting.........................................................................268 11.5.1 Analyzer........................................................................................268 11.5.2 Sensors.........................................................................................269 11.5.3 Motors...........................................................................................269 11.5.4 Reagent Tray ................................................................................270 11.5.5 Tube Entry ....................................................................................270 11.5.6 ISE................................................................................................271 11.5.7 Temperature Monitor ....................................................................271 11.5.8 Capacitive Sensor.........................................................................271 11.5.9 Probe ............................................................................................271

11.6 Figures .......................................................................................................272 11.6.1 Hopper Module: J12 and J17.......................................................273 11.6.2 Foam Stripping Around Reaction Wheel Removed ......................273 11.6.3 Reagent Tray-Encoder Slots and Index (Home) Flag) .................274 11.6.4 Index and Position Sensor............................................................274 11.6.5 Syringe Pump Module ..................................................................275 11.6.6 Fluid Arm PCB, Mounting Screws and Ribbon Cable...................276 11.6.7 STEP Cover Rails, Left.................................................................276 11.6.8 STEP Cover Rails, Right ..............................................................276 11.6.9 Hopper Module .............................................................................277

11.7 Troubleshooting Procedures ......................................................................279 11.7.1 ISE Troubleshooting by Error .......................................................279 11.7.2 Cleaning ISE Sample Port ............................................................285 11.7.3 Wash Plate Assembly Cleaning Procedure ..................................287 11.7.4 Testing and Removing Probe Clogs .............................................290 11.7.5 Probe Alignment Procedure..........................................................293 11.7.6 Cuvette Waste Box Sensor Cleaning Procedure..........................294 11.7.7 Removal and Replacement of Hopper Module.............................297

INDEX ......................................................................................................... 301

ADDENDUM A: INTRODUCTION TO QUALITY CONTROL PRACTICES IN THE CLINICAL LABORATORY

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About This Manual This manual is written for operators that use and maintain the ACE 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 • Troubleshoot the system

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 system consists of an analysis module, a computer workstation and an uninterruptible power supply (UPS).

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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.

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Glossary

Phrase Description

Analysis Module The component of the ACE 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 Assembly

A cap and tubing assembly that is attached to the CAL-A container before it is 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 Cartridge

A plastic sleeve that holds 20 cuvettes. The cartridge facilitates loading the cuvettes 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 Box

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

Diluent Cap Assembly

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

Fluid Arm Probe Assembly

Stainless steel probe used to aspirate and dispense system fluids.

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 Electrode

A potentiometric device used to determine the activity of sodium, potassium or 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.

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.

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Phrase Description

Open Channel Bottle

A reagent bottle that is defined by the user. An open channel bottle may be filled 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 Cup Holder

See Cup Segment.

Sample/Reagent Tray

A tray located within the analysis module used to hold up to five sample segments 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 Assembly

Attached to the liquid waste container.

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.

Workstation The workstation consists of the computer, monitor, keyboard and printer.

ACE Clinical Chemistry System Operator’s Manual

P/N 701164 Rev 2/03 1

1 Introduction

1.1 Intended Use

The ACE 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 37º 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 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 12 º ± 2 ºC to maximize their on-system stability and on screen system temperature reads 8 º ± 1 ºC in temperature monitor. 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 two 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 waste container 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 Clinical Chemistry System


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2 Description

The ACE system consists of an analysis module and a computer workstation (Figure 2). The computer workstation includes a computer, monitor, keyboard and printer. An uninterruptible power supply (UPS) and line conditioner are also provided.

Figure 2. ACE Clinical Chemistry System Modules

Note: Some systems may include a combined UPS/Line Conditioner.

Analysis UPS Computer Monitor Keyboard Line Printer Module Conditioner


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2.1 Analysis Module

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

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.

Reagent Access Cover

Probe

Sample/Reagent Tray

Cuvette Hopper

Indicator Panel STEP

Containers

Optional ISE


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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 serial 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 system:

Analytical Chamber

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

Reagent Compartment

The temperature within the reagent compartment is monitored so that reagents are maintained at 12º ± 2 ºC.

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 ºC ± 0.5 ºC and bonded to the bottom of the arm. The heater is regulated by the CPU.

2.1.6 Indicator Panel

The indicator panel contains signal lamps to inform the operator that the designated module can be accessed:

• Cuvette Hopper. Illuminated when a cuvette cartridge can be inserted into the slot.

• Reagent/Segment Access Cover. Illuminated when the Reagent/Segment access cover can be opened.

• Fluids Compartment. Illuminated when the fluid compartment door can be opened.


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2.1.7 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 (see page 181).

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.

Figure 5. Reaction Wheel

2.1.8 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.

2.1.9 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.

Cuvettes


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2.1.10 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.

2.1.11 System Sensors

Sensors are used to monitor various system states.

Component Function

Cuvette Waste Box Monitors if waste box 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.

2.1.12 CPU Interface Board

A 80C196 microcontroller acts as the master controller of the ACE instrument. It controls communication between the instrument and the computer module.


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2.1.13 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 Motor

Moves the sample/reagent tray.

Reaction Wheel Motor Moves the reaction wheel.

Fluid Transfer Module Motors

Control rotational and vertical motion.

Sample Tube Entry Port (STEP) Motors

Move sample tube into position for sampling and return it to be removed from the STEP.

Optional ISE Motor Pumps fluids to be analyzed by ISE.


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2.1.14 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 Housing

Maintains a capillary liquid junction between the reference electrode and the sample.

Reference Electrode Provides a stable reference potential for measurement of ISE values.

2.2 Uninteruptible Power Supply

An uninterruptible power supply (UPS) is included with 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 can not. 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 sample cup holder, or 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 sample cup holder following the loadlist. After the sample cup holder 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.

Figure 9. Cup Segment

Sample Sample Cup Cup Holder


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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 type, 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 116 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 113 and 135 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-B. One of the two-level solutions used for calibration of sodium, potassium and chloride measurements.

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.


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2.5 Computer Workstation

The computer workstation provides the user interface for the system. The components of the workstation are shown in Figure 2.

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 101-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.

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.

F12 Instrument Access

Displays the Instrument Access menu.

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.


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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.

Ctrl F6 RTI Simultaneously pressing both keys enables or disables the rapid tube input mode used when placing multiple samples in

temperature will not be ilibrated.

2.5

The

the STEP.

Ctrl F5 OT Simultaneously pressing both keys overrides thedefault timer (started after reinitialization). Tests processed until the system temperature has equ

Esc function number pad/ LED indicator key keys option keys lights

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

.3 Printer

impact dot matrix printer allows the various system reports to be printed.

Ctrl Alt Ctrl Arrow key key key keys


2.5.4 Monitor

The color 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, operator alerts and instructions concerning the highlighted command or field are displayed at the bottom of the screen.

F

Analyzer State Menus User Access Level Date and Time

Instructions or Variable Operator Alert Information Function Key Indicators Offerings

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igure 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 or calibration test request.

Reports Create various system reports.

Loadlists Set up a group of up to 15 samples in a cup segment prior to placing the segment on the system.

Journals View the permanent records of certain system events.

Purge Remove inactive patients from the system.

Utilities Displays a submenu of system utilities.

Diagnostics Test system functions and troubleshoot system.

Setup Configure system hardware and customize system software.

User Access Log on or off the system.


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2.6.4 Requisitions

The Requisition menu is used to create requisitions for patient, QC and calibration 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 can not 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 Loadlist

The Loadlist option on the Main menu displays the Loadlist 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 Loadlist screen will display a list of the current segments. If there are no segments currently saved on the system, the loadlist 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 Purge

The Purge menu is used to remove a patient from the system and reset the test counter.

Command Purpose

Patient Data Removes patients who have had no activity since a specified date from the database.

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 Reinitializes the slave processors and the C196 board.

Miscellaneous Perform functions related to maintaining the instrument or preparing it for 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 Set up an open channel reagent bottle.

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, enable a LIMS, require entry of patient’s first name when creating a requisition, turn off the reagent cooling system, set the sound level of the beeper, specify the type of barcode scanner, specify the sample lifetime, and specify whether leading zeros are suppressed from Accession numbers.

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 F12 key 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: Failure to press F12 for access will cause an alarm to sound when a cover or door is opened inappropriately. An error message will appear and the system may have to be reinitialized before routine operation can continue.

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 exchange a depleted 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 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 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 Time

Between 1 and 15 minutes depending on test(s) ordered

Calibration Frequency

Optical Monthly sample delay and optical calibration.

Photometric Test dependent (refer to package insert)

Potentiometric Automatic every three hours

Analytical Temperature

37 °C ± .3 °C

Ambient Room Temperature

15 °C (59 °F) to 32 °C (89.6 °F)

Humidity 20 to 80% RH (non-condensing)

Maximum Cuvette Capacity

248

Power Rating

Analyzer 100-120 VAC, 47/63 HZ, 5 Amps Max.

Optional 200-240 VAC, 47/63 HZ, 2.5 Amps Max.

ACE Nominal 350 Watts Max (Analyzer + Printer + Monitor)

Monitor 90-240 VAC, 50/60 HZ, 0.5 amp, 30 W

Printer 120 VAC, 1 amp (see back of printer for all other voltages)

Sample Delivery

Presentation to System

Closed or open tube Sample cups individually Sample cups in groups of up to 15 on cup segment

Segment Capacity 5 in combination (cup and/or well)

Tube Size for Direct Sampling

75 to 100 mm length; 13 to 16 mm diameter


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Stopper Styles Rubber stopper, VACUTAINER® with Hemogard™ Closure or stopperless.

Fill Volume Required for Tube sampling

Between 0.9 inches and 2.23 inches from top of glass tube

Serum Volume Required for Tube Sampling

Minimum 0.5 inches above clot or separator

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 available June 2003) and Set C, Codabar and Interleaved 2 of 5

Barcode Placement Zone

Within the range of 0.09 inches and 2.35 inches from top of glass tubes with a maximum of 5° skew (slant)

Sample Delivery Capacity

3-200 µL in 1 µL increments

Typical Volumes Used 3-20 µL

Sample Delivery Precision

Less than 5% CV at 3 µL

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 Capacity

40 bottles 20 with 30 mL capacity 20 with 12 mL capacity

Reagent Compartment Temperature

8 °C + 1 °C at the reagent sensor

12 º ± 2 ºC for reagent bottles

Reagent ID Positive ID by computer coded labels on bottom of bottles

Reagent Delivery Capacity

3-500 µL in 1 µL increments

Reagent Delivery Precision

Less than 0.5% CV

Level Detection Automatic with liquid level sensor

Reagent Integrity Onboard working lifetime clock

Optical System

Absorbance Measurement


P/N 701164 Rev 2/03 33

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 µL

Analysis Cycle 10 seconds

Potentiometric System

Sample Type serum

Assay Volume 156 µL (a minimum of 206 µL required in cup to accommodate probe depth and dead volume)

Analytes Measured Sodium Potassium Chloride

Analysis Cycle 90 seconds

WORKSTATION

Computer Processor IBM-compatible PC®

RAM Memory 4 MB

Graphics Adaptor Color VGA compatible

External Disk Drive 3.5 in., 1.44 MB

Hard Disk Drive 85 MB (minimum), self parking

Operating System MS-DOS 5.0 or later

Keyboard Type 101 key

Monitor

Type Color VGA compatible

Resolution 640 pixels by 480 pixels

Printer

Type 9 pin impact dot matrix IBM-PC® compatible with Epson FX mode

Speed 200 character per second

Characters per line 80, 96 and 132

Interface Centronics parallel compatible

Paper Type 9.5 in. x 11.0 in. fanfold


34 P/N 701164 Rev 2/03

Database Capacities

Analyzer Procedures

(Performance) 15

Bottles 250

Controls 20

Doctors 200

Dyes 15

Loader Procedures

(Performance) 2

Panels 16

Patients 500

Requisitions 2500

Tests 200

Note: Specifications are subject to change without notice.


P/N 701164 Rev 2/03 35

3 Principles of Operation

The ACE 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.


36 P/N 701164 Rev 2/03

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.


P/N 701164 Rev 2/03 37

3.1.3 Analysis Sequence

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

Event Purpose

Requisition Entry/ Sample Loading

Create requisitions, order tests and load samples.

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 but allows processing to continue.

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.


38 P/N 701164 Rev 2/03

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.


P/N 701164 Rev 2/03 39

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.


40 P/N 701164 Rev 2/03

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 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 Non-Linear Least Squares Fit

The response and result have a non-linear relationship. Four to six calibrators can be used to determine the convergence of the curve.


P/N 701164 Rev 2/03 41

3.1.11 Routine Chemistry Equations

The calculation equations used for routine chemistry tests performed on the ACE 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 V(T) ]} x Cal Factor or Factor

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 V(T) - (AESBW1 – AESBW2)] x Cal Factor or Factor

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 V(T) - (AUERBW1 – AUERBW2)] x Cal Factor or Factor

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.


42 P/N 701164 Rev 2/03

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

Result = {[(AUT2W1 – AUT2W2) – (AUT1W1 – AUT1W2)] - [(AERBT2W1 – AERBT2W2) – (AERBT1W1 – AERBT1W2)]} 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.


P/N 701164 Rev 6/04 43

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 Last Name, Patient ID, Accession number, and at least one test to be run are required for a patient requisition. The Patient First Name is also required, if this is specified in Hardware Setup.

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 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.


44 P/N 701164 Rev 6/04

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

Optical Data Flags

Flag Description

ANALZ (automatic)

Problem detected on the upper or lower photodetector output limits, the upper or lower limits on the averaged transmission or intensity values or on the comparison of data to system offsets.

ANALZ (automatic)

Absorbance for a cuvette exceeds the maximum allowable value.

NEGABS (automatic)

Absorbance for a cuvette is less than the minimum limit (-0.05).

MXINIT (configurable)

Optical data for the early data point exceeds the maximum limit defined in the test parameters.

MNINIT (configurable)

Optical data for the early data point is less than the minimum limit defined in the test parameters.

DEPL (configurable)

Substrate depletion. Error occurs when ∆A between the early data point and any of the first 4 readings in the reaction exceeds the limit set in the test parameters.

MXRBDP (configurable)

Optical data point for the internal reagent blank exceeds the maximum limit.

MNRBDP (configurable)

Optical data point for the internal reagent blank is less than the minimum limit.

Response Flags

Flag Description

SIGN (configurable)

Reaction direction is incorrect based on the test parameters.

SE (configurable)

Standard error of linear regression in slope response calculation (> max. limit).

LT LC, GT HC (automatic)

Response is either less than the lowest or greater than the highest calibrator. Check is performed if Four Parameter Non-Linear Least Squares Fit or Non-Linear Interpolation is used in results calculation.

MAXERB (configurable)

Response for the external reagent blank exceeds a maximum limit.

MINERB (configurable)

Response for the external reagent blank falls below a minimum limit.

RSS (configurable)

The root-sum-square of the residuals for a quadratic least squares fit exceeded the maximum limit.


P/N 701164 Rev 6/04 45

Result Flags

Flag Description

LIN (configurable)

Reported when a sample result exceeds the linearity limit for the 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 (automatic)

A sample result is either less than the lowest or greater than the 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 (automatic)

Result is less than zero (negative result).

FORMAT (automatic)

Result exceeds the allowable format field size.

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 (automatic)

Calibrator response is zero. A ratio cannot be determined (division by zero is not permitted).

CALFAC (configurable)

Ratio of the concentration of a calibrator or a corrector to its 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 (configurable)

The expected result for a calibrator deviates from the calculated 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 (configurable)

The correction response for a corrector deviates from its stored response by more that the maximum limit set.

NONMON (automatic)

A calibration curve is not sequentially increasing or decreasing.

CONVRG (automatic)

Improper curve fit using Four Parameter Non-Linear Least Squares Fit calculation.

CAL SN (automatic)

Correction changed the sign of a calibrator response in a correction run.


46 P/N 701164 Rev 6/04

Result Verification Flags

Flag Description

H (configurable)

Patient result exceeds upper range of normal limit configured in the test parameters.

L (configurable)

Patient result falls below lower range of normal limit configured in the test parameters.

HH (configurable)

Panic result. Patient value exceeds upper panic limit programmed in test parameters.

LL (configurable)

Panic result. Patient value is less than lower panic limit 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 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 result by the slope and adding the value of the y-intercept.


P/N 701164 Rev 6/04 47

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.


48 P/N 701164 Rev 6/04

3.2 Operational Precautions

Certain precautions must be followed while using the ACE 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 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 are intended to be discarded after being used once. They can not 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.


P/N 701164 Rev 6/04 49

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 one hour.

• Never turn off the power to the analyzer for an extended period (i.e., overnight) 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 one hour, 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.


50 P/N 701164 Rev 6/04

4 System Setup

Unpacking and installation of the ACE 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, Computer Workstation, Monitor) 3

Computer Workstation 1

Keyboard 1

Monitor 1

Printer 1

Uninterruptible Power Supply (UPS) 1

AC Line Conditioner 1

Printer Cable 1

Analyzer Interface Cable 1

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


P/N 701164 Rev 2/03 51

Article Quantity

Air Filters 2

Cup Segments 5

Well Segments 3

Sample Cups 1 bag

Cuvettes 1 box

Seglets 1 bag

Evap Caps 1 box

Cuvette Waste Box 1

BIOBAGS 1 box

Printer Paper 1 box

Keyboard Overlay 1

Spare Fuse 1

Maintenance Log 1

Master Log 1

4.1.2 ISE Parts

Article Quantity

Tubing Set, Pump 1

Air Inlet Tubing (3.5 in.) 1

Cap, CAL-B Bottle Assembly 1

Waste Transport Tubing (8.5 in.) 1

CAL-A Transport Tubing (10.0 in.) 1

Sample Transport Tubing (8.5 in.) 1

Measuring Chamber Waste Tubing Assembly (13.0 in.) 1

Measuring Chamber Inlet Tubing (2.5 in.) 1

Reference Housing Outlet Tubing Assembly (12.0 in.) 1

Cap, Reference Bottle Assembly 1

Reference Housing Inlet Tubing (10.75 in.) 1

Cal A bottle cap assembly 1

ISE Service Syringe 1

4.1.3 Materials Required but Not Provided

Article Quantity

GEMCAL™ Reference Serum 1 bottle

QC1 (Normal) Chemistry Control 1 bottle

QC2 (Abnormal) Chemistry Control 1 bottle

Reagent Grade Deionized Water 1bottle

Class A volumetric pipettes, 3 and 5 ml 1 set

Household Bleach, unscented (5.25% sodum hypochlorite)

10 mL


52 P/N 701164 Rev 2/03

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 and Workstation require approximately 1.2 m2 (13.3 sq ft.) of floor space. For easy operator access, the system should be located 75 to 100 cm (30 to 40 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.


P/N 701164 Rev 2/03 53

4.2.2 Physical Dimensions and Space Requirements

The dimensions of the analyzer, workstation components and uninterruptible power supply (UPS) are as follows:

Analyzer

Keyboard

Height 43.2 cm (17.0 in.) Height 4.6 cm (1.8 in.)

Width 69.9 cm (27.5 in.) Width 49.0 cm (19.3 in.)

Depth 57.2 cm (22.5 in.) Depth 21.1 cm (8.3 in.)

Raised Height 91.4 cm (36.0 in.)

Weight 68.3 cm (150 lb.)

Computer

Printer




Monitor

UPS/Line Conditioner




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 91.4 cm (39.0 inches) to raise the deck.

• Computer/Monitor – Maintain a clearance of 7.6 cm (3.0 inches) at the rear to allow for cable connections.

• Printer – Maintain a clearance of 29.2 cm (11.5 in.) at the rear for loading printer paper.

• UPS/ Line Conditioner – Maintain a clearance of 7.6 cm (3.0 inches) at rear for cable connections.


54 P/N 701164 Rev 2/03

4.2.3 Electrical Service

The ACE system requires electrical service that provides power at the rated voltage and frequency. Consult section 0 for absolute power requirement values.

The power source for the modules (UPS, analyzer, monitor, 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 system modules as shown in Figure 13.

4.2.5 Connecting the Modules

All cable connections for the modules are provided by the manufacturer.

To protect the system from a power failure, connect the power cords from the analysis module, the computer, the monitor and printer into the uninterruptible power supply (UPS). Connect the UPS power cord into the electrical supply outlet.

Routing of the communication cables between the analysis module, the computer, the keyboard, the monitor and printer is shown in Figure 13.

Figure 13. Module Positions and 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. Power on the computer if necessary. 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. Power on the computer if necessary.

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 165 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.

4.3.3 Setting the Printer Parameters

Most systems are supplied with a Panasonic printer (KX-P1150). In order for the printer to function properly, four of the default parameters must be changed.

Note: Contact Alfa Wassermann Diagnostic Technologies, LLC Technical Service if you have not been supplied with the Panasonic printer.

1 Turn the power on at the UPS.

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

2 Press the X key to display a DOS prompt.

3 Insert the Panasonic Setup Disk into drive A.

4 Type a: and press Enter to display the drive A DOS prompt.

5 Type Setup and press Enter. An informational message is displayed on the screen.

6 Press any key to display the country keyboard menu.

7 Using the up and down arrow keys, select USA and press Enter. The Setting menu is displayed.

8 Select the Emulation setting using the arrow keys.

9 Press the left or right arrow key until EPSON is displayed.

10 Use the up and down arrow keys to select the Character Set setting.

11 Press the left or right arrow key until Graphic 2 is displayed.


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12 Use the up and down arrow keys to select the Zero Font setting.

13 Press the left or right arrow key until SLASHED is displayed.

14 Use the up and down arrow keys to select the Auto CR setting.

15 Press the left or right arrow key until ON is displayed.

16 Press F10 to save the settings. The message Do you want to send your settings to the printer? is displayed.

17 Use the left or right arrow key to select YES.

18 Press Enter. The message Are you sure? is displayed.

19 Press Enter.

20 Press F2. The message Save to disk? is displayed.

21 Use the left or right arrow key to select YES and press Enter.

22 Press Esc. The message Exit to DOS is displayed. Use the left or right arrow key to select YES.

23 Press Enter. The DOS prompt is displayed.

24 Remove the disk from drive A and store it in a safe place.

25 Turn the power off at the UPS, wait 20 seconds, then turn the power on at the UPS.

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 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 174 for instructions on enabling the ISE. Refer to page 175 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.) included in the ISE Reference and Sample Tubing Kit P/N 402771

39-11965

Reference Housing Outlet Tubing Assembly, 305 mm (12.0 in.) included in the ISE Reference and Sample Tubing Kit P/N 402771

39-11966

Reference Housing Inlet Tubing Assembly, 273 mm (10.75 in.) included in the ISE Reference and Sample Tubing Kit P/N 402771

505119-1


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Tubing Segments Part Number

Measuring Chamber Inlet Tubing, 64 mm (2.5 in.) included in the ISE Silicone Tubing Kit P/N 402770

505118-1

Sample Transport Tubing, 216 mm (8.5 in.) (same as Waste Transport Tubing) included in the ISE Silicone Tubing Kit P/N 402770

505118-3

CAL A Transport Tubing, 254 mm (10 in.) included in the ISE Silicone Tubing Kit P/N 402770

505118-4

Waste Transport Tubing, 216 mm (8.5 in.) (same as Sample Transport Tubing) included in the ISE Silicone Tubing Kit P/N 402770

505118-3

Air Inlet Tubing, 89 mm (3.5 in.) included in the ISE Silicone Tubing Kit P/N 402770

505118-2

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 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.

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.

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 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 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.

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 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.

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 Tygon) 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 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 Tygon) 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 Tygon) 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.

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.

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 of the right 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.

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.


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4.5.4 ISE Reagents

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

Refer to pages 95 through 97 for instructions.

Priming ISE Lines

1 Display the Pump and Valve Operation screen (see the previous section).

2 Select PUMP SPEED. Type 100 and press Enter to set the pump speed to 100 rpm.

3 Select AIR: and press the spacebar to operate the pump and valve.

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

5 Press the spacebar to stop the pump.

6 Select CAL-A and press the spacebar to operate the pump and valve.

7 Observe the fluid manifold for CAL A flow.

8 When CAL A appears in the fluid manifold, press the spacebar to stop the pump.

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

9 Select PUMP SPEED. Change the pump speed to 40 rpm.

10 Select AIR and press the spacebar.

11 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.


13 Select CAL-B and press the spacebar to operate the pump and valve.

14 Verify that CAL-B flows into manifold, lines and electrodes.


16 Select SAMPLE and press the spacebar.


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17 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 at 40 rpm 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.


19 Close the container access door.

20 Press Esc until the Diagnostics menu is displayed.

Verifying Fluid Flow

1 Select PUMP SPEED. Verify that the speed is set at 40 rpm.

2 Select CAL-A and press the spacebar to operate the pump and valve.

3 Verify that CAL-A solution is flowing into manifold, through the lines, and into the electrode chamber.

4 Verify that no air bubbles are present.


6 Select AIR and press the spacebar.

7 Verify that no fluid droplets are present.

8 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.



11 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.


76 P/N 701164 Rev 2/03

5 Daily Preparation for Operation

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

Perform Daily Maintenance

Check System Status

Load Consumables

Load Reagents

Replenish Solutions

Empty Cuvette WasteB

5.1 Daily Maintenance

Perform daily maintenance:

Procedure Page

(DM-1) Remove Condensation from Reagent Compartment 217

(DM-2) Clean Wash Bath and Probe Pathway 218

(DM-3) Clean Exterior of Probe 219

(DM-4) Check Probe Alignment 220

(DM-5) Clean and Condition ISE 221


P/N 701164 Rev 8/03 77

5.2 Checking Status

5.2.1 Power

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

Note: The power to the UPS, analyzer and computer 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 (EXPIRED is shown in the Volume field for that bottle) and 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.


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.



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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.


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.



P/N 701164 Rev 2/03 81

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.


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.



P/N 701164 Rev 2/03 83

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.


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.


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.


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, purging of patient data is recommended (refer to page 166).


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 F12 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 Note the Hopper Access indicator on the Indicator Panel (Figure 3). When the indicator is illuminated, carefully slide the end of the cartridge into the hopper until it stops.

Important: Always wait for the indicator to illuminate 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


P/N 701164 Rev 2/03 87

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 (Figure 8). 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.


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:

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 Note the reagent/segment access indicator. When the indicator is illuminated, open the segment access cover.

Important: Always wait for the indicator to illuminate before opening the segment access cover.

7 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).

8 Close the access cover.

9 Press F10.

10 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.


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:

5 Obtain an empty cup segment.




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7 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).


9 Press F10.

10 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


2 Select Reagents. The messages Pausing the Instrument… and Positioning the sample ring… are briefly displayed before instructions for loading reagents are displayed:

3 Note the reagent/segment access indicator. When the indicator is illuminated, open the reagent access cover.

Important: Always wait for the indicator to illuminate before opening the reagent access cover.


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4 Obtain the reagents that are needed.

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

5 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.

6 Close the reagent access cover.

7 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


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.

5.5.2 Emptying System Waste

Biohazard: Material in the ACE 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 lower compartment by lifting it and then sliding it out.

3 Remove the cap assembly from the waste container.

4 Empty the contents of the waste container.

Note: Dispose of the waste according to your facility regulations.


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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.

8 Slide the waste container forward into its position in the lower compartment and allow it to drop downward into position.

5.5.3 Replacing System Diluent

1 Check the level of system diluent. Replace the system diluent if there is less than 1/2 inch of liquid in the container.

2 Remove the system diluent container from the upper right compartment by lifting it (using the finger grips) and pulling it out.

3 Remove the cap from a new container of system diluent.

4 Unscrew the used system diluent container from the cap assembly and discard it.

5 Place the system diluent cap assembly into the new system diluent container and tighten it.

6 Gently slide the system diluent container forward into the upper right compartment and allow it to drop downward into position.

5.5.4 Replacing ISE CAL-A

1 Check the level of ISE CAL-A. Replace CAL-A if there is less than 1/2 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 upper left compartment by lifting it (using the finger grips) and pulling it out.

3 Remove the cap from a new container of ISE CAL-A.

4 Unscrew the used ISE CAL-A container from the cap assembly and discard it.

5 Place the ISE CAL-A cap assembly into the new ISE CAL-A container and tighten it.

6 Gently slide the ISE CAL-A container forward into the upper left compartment and allow it to drop downward into position.


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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 1/4 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 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 Open the waste box access door on the left side of the analyzer.

2 Remove the waste box by pulling it out (using the tab at the bottom of the box).

3 Remove the BIOBAG containing the used cuvettes from the waste box.

4 Seal the bag with one of the provided ties.

5 Dispose of the used cuvettes according to your facility regulations.

6 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.

7 Slide the waste box back into the compartment.

8 Close the waste box 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 29). The minimum information that is required for ordering tests on a patient sample is the Patient Last Name, Patient ID, Accession number (which can be automatically assigned by the system), and the test(s) to be run.

Note: The Patient First Name is also required, if this is specified during Hardware Setup. Refer to page 177 for instructions.

Existing Patient

Select thePatient

(Section 6.1.3)

Order Tests(Section 6.2)

New Patient

Enter PatientInformation

(Section 6.1.2)

Order Tests(Section 6.2)

Figure 29. 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. These fields can not be edited once the requisition is saved in the database.

The FIRST NAME: field is also required (and cannot be edited), if specified during Hardware setup. Refer to page 177 for instructions.

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 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 can not be saved in the database until the Patient Last Name, Patient ID, and Accession number (which can be automatically assigned by the system) are entered and at least one test has been ordered. The Patient First Name is also required, if specified in Hardware Setup.


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6.1.2 Initiating a Requisition for an Existing Patient


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 100 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 can not 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 the previous sections):

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 109 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




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 109 for additional information.

Source requisitions for remote tests must be prepared first.


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 two 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. 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 (see Section 6.1).

2 Order the source test.

3 Note the Accession number for the source test.

4 Press F10 to save the source test requisition.

After the source requisition is prepared, the GLU remote test can be included on the requisition:

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 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 can not be deleted.






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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 your initials and 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 Last Name, First Name, Patient ID, and Accession cannot be changed once a requisition is created and accepted.





112 P/N 701164 Rev 6/04


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

Note: Last Name, Patient ID, and Accession cannot be modified. If entry of First Name is specified during Hardware Setup, First Name cannot be changed either.

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.



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 below). 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.



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 79). 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.



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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 126 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.


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.

1 Select Correction from the Requisitions menu. The Correction Requisition screen is displayed, with the first test to be corrected selected.

Note: Refer to the Calibration Requisition screen.

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. If the required correctors 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 correctors may be run alone, or additional samples can be added to the loadlist.



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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.


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 two 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.

Alternately, an aliquot of a single sample can be poured 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.

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:



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 30).


8 Press F10. The ordered tests will be run on the sample.

Figure 30. 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 F12. The Access menu is displayed:

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) and press Enter. The tray is rotated to the correct position. Then, the message Fill the cup in the instrument… is displayed.

7 Open the segment access cover and add sample to the cup indicated by the arrow.

8 Close the cover and press F10.

9 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 F12. The Access menu is displayed.

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).


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.



7.1.6 Removing an Inactive Sample Cup

1 Press F12. The Access menu is displayed.

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).


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.




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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 result must first be deleted.

11 Display the patient requisition containing the test to be rerun.

12 Select the test to be rerun (use the arrow keys).

13 Press F6. The result field is selected.

14 Press F4 to clear the field.

15 Press F10. A message to confirm the deletion is displayed.



18 Press F10 to delete the result. Repeat steps 2 through 7 to rerun additional tests.

19 Press F10 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 the allowable time period.


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7.2 Running a Batch of Samples

Samples can be loaded and run as a batch. A loadlist 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 loadlist is created prior to loading a batch of samples. The loadlist shows each sample that is to be run and the numbered position where it must be placed on the cup segment. The loadlist can be printed.

1 Select Loadlist 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 loadlist is displayed.

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


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Note: If a new loadlist is displayed, type the segment number (1 to 99) and press Enter. The first available cup position is highlighted.

3 Add the first sample to the loadlist by typing the patient’s name.

Note: For convenience, the system will display all names containing the letters as they are typed. The desired sample can then be selected from the list.

Alternately, press F2 and select the sample from the list.

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

5 Place the filled sample cup in the cup segment position shown on the loadlist.

6 Repeat Steps 3 through 5 for the remaining samples on the loadlist.

Note: Alternately, press F5 to automatically fill the loadlist with pending patient and control requisitions.

To delete a requisition from the loadlist, select the requisition and press Delete.

Press F8 to print the loadlist.

7 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.



9 Place the cup segment on the posts.


11 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.

Note: For systems equipped with an optional barcode reader, place barcoded tubes in the STEP, following the instructions in section 7.1.1.

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: 51 LOCATION: 221 PATIENT ID: 112-32-4567 SEX: M COMMENT:

D/T DRAWN: 06/09/00 13:30 ACCESSION: 719721

BY: KMO D/T ENTERED: 06/09/00 14:39 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: 06/09/00 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: 06/13/00 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: 06/13/00 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 143) 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.


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 can not 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 the Configuration section 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.

7.3.6 Entering Calculation Test Values

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

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.


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7.3.7 Editing 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.


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 (normal and abnormal) 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 QC1 and QC2. Controls should be 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 Controls

If results from the tests on freshly-prepared controls are within the acceptable range of values, patient results may be reported.

Re-calibrate (where applicable)

If control results from the re-calibrated tests are within the 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.


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, 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 can not 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 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.


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 sample cups to be run for each level (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 can not 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.

Note: If multiple cups contain the same sample, press F7 to repeat the entry.

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 Messages During the Run

Certain events or conditions may occur during a run. If this happens, a warning indicator is displayed at the bottom of the screen (Figure 31).

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

Message Reason Action Required

ON-HOLD One or more tests cannot be completed.

Refer to Section 5.2.4

VERIFY A result requires manual verification

Refer to Section 7.3.4

STAT A STAT requisition is incomplete.

No action is required. 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 by the operator to allow instrument access.

Complete the activity requiring access and close the access door. Press Esc until the indicator is no longer displayed.

TEMPERATURE The cuvettes in the reaction wheel are not at the correct temperature. This usually occurs upon exit from a diagnostics routine.

No action is required. The system will begin operation automatically once the correct temperature is reached.

ATTENTION An event has occurred that requires operator notice or attention.

Refer to Section 11 – Troubleshooting. Press F9 to display the attention log and cancel the alarm.


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Figure 31. Warning Indicator

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 F12 and remove all active samples.


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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.

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 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 F12 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.

7.7.3 Backup System

It is recommended that a system backup be performed on a daily basis. Refer to section 8.5.1 for instructions.

7.8 Powering Off the System

At the main menu, type the letter “x”. At the DOS prompt, power off the system from UPS.


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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 (from Archive Disk)

Complete information for a specified patient requisition is 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 photometric 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


2 Select Cumulative. A list of patients with at least one completed requisition is displayed.


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.



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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.


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 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), each patient requisition must be reviewed before a report can be printed.


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.


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.


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.


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.



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 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.


2 Select Statistics. The Control Cumulative Statistics report is generated and displayed.



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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:



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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.


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.



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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:



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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.

2 Select the desired type (use the arrow keys).

3 Press Enter. The report is generated and displayed.



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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.



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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


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 Purging Patient Files

The Purge function removes patient files that have been inactive for a specified period of time. If the Archiving mode is enabled during system configuration (page 208), prompts are displayed to archive (copy) the files to a 3.5 inch disk before they are purged. Otherwise, the files will be purged directly on command.

8.6.1 Purging Inactive Files without Archiving

1 Select Purge from the Main menu, then select Patient Data. If archiving is not specified in system configuration, a warning message is displayed:

2 If you wish to purge patient data without archiving to disk, press F10. A message is displayed to enter the starting date for the period of inactivity.

Note: If you wish to archive the patient data before purging, press Esc to discontinue the purge procedure. Then, enable the Archiving mode (page 208) and repeat the purge procedure.

3 Type the date and press F10. A list of patients that meet the inactivity criteria is displayed.

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

4 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.

5 Press F10. The selected patient data is purged from the system.


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8.6.2 Archiving and Purging Inactive Files

1 Select Purge from the Main menu, then select Patient Data. If archiving is not specified in system configuration, a warning message is displayed:

Note: Press Esc to discontinue the purge procedure. Then, enable the Archiving mode (page 208) and repeat the purge procedure.

2 Type the date and press F10. A list of patients that meet the inactivity criteria is displayed.

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

3 Review the list of patients.

Note: A patient can be excluded from the purge list by selecting the patient (using the arrow keys) and pressing Delete.

4 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.

5 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.

6 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.

7 Insert a formatted 3.5 inch disk into drive A.

Note: Use a 3.5 inch IBM-compatible disk.


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8 Press F10. A status message is displayed as patient data is copied to the 3.5 inch disk.

9 When the backup is complete, instructions to remove the 3.5 inch disk are displayed.

10 Remove the 3.5 inch disk and press any key. The selected patient data is purged from the system.

11 The screen displays “Purging Patients” and returns to the Purge menu when done.

12 Label the 3.5 inch disk and store it in a safe place.

8.6.3 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.


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 backup disk and press any key. The system is initialized and the Restore menu is displayed.


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8.6.4 Displaying or Printing an Archived Patient Requisition

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.



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8.7 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.

8.7.1 Deleting a Test

Refer to section 6.3.1.

8.7.2 Deleting a Requisition

Note: A requisition can not be deleted if archiving of patient data is required (see page 208).

1 Select Patient from the Requisitions menu. A list of patients that have

already been entered into the system 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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8.7.3 Deleting a Patient

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


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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8.8 Purging 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.

8.8.1 Resetting All Counts

1 Select Purge from the Main menu. The Purge menu is displayed.

2 Select 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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8.8.2 Resetting Individual Counts

1 Select Purge from the Main menu. The Purge menu is displayed.

2 Select 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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9 Configuration

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.


2 Select CALIBRATION: (under ISE) and press F2. The screen displays STANDBY and STAT READY options.

3 Select the desired mode and press Enter.



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9.1.3 Enabling the Laboratory Information Management System (LIMS)

The ACE 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.


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.


Note: Enabling LIMS requires that transmission of patient reports and QC reports are configured (see section 9.10.9).


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9.1.4 Specifying Entry of Patient First Name

The ACE system can be configured so that a patient first name is required in all patient requisitions.


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.



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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.


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.


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 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.


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 (available in June 2003) and Set C, Codabar or Interleaved 2 of 5.

Note: This configuration option is to be used at the discretion of MIS 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.


2 Select HOURS: (under SAMPLE LIFETIME) and press F2. The screen displays the sample lifetime options.

3 Select the desired option and press Enter.



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9.1.10 Specifying Suppression of Leading Zeros in the Accession

The ACE 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.


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 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.

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.



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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 193).

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 193) 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 Press F10. The Parameter Groups menu is displayed. A check mark is displayed next to Calculation Method if changes were made.


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.



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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.



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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.



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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 workstation so they can be included on the ACE 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 (Linking Tests)

Tests that are run using more than one sample. The results of 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 182 through 187 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



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 182 through 186 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.


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



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 182 and 185 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.


9.3.4 Remote Test 1 Select Tests from the Setup menu. The Setup Tests list is 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 182 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_F 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 first test 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.



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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 184).

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 (eg. 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 184).

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.


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.



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9.5.3 Modifying the Lot Number for a Control


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 196).




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9.5.4 Deleting a Control


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 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


2 Select the desired Panel and press Enter to display the Setup Panels screen for the selected Panel.

3 Edit the Panel as required.


9.7.3 Deleting a Panel


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


2 Select the desired name and press Enter to display the Setup Doctors screen.

3 Edit the name as required.


9.8.3 Deleting a Doctor’s Name


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.

QC Reminder Specify whether a reminder to run control samples is displayed at defined intervals.

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 9 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 QC Reminder

1 Select QC Reminder. The Quality Control Requisition Reminder form is displayed:

2 Press F2 to display choices (YES and NO) for the ENABLE REMINDER: field. Select the choice (using the arrow keys) and press Enter. The TIME OF DAY: field is selected.

3 (If enabling) Type the time of day for the first QC reminder and press Enter.

Note: Use the 24-hour time format (e.g., 15:30 for 3:30 p.m.).

4 Repeat Step 3 if additional QC reminders are needed.

5 Press F10 to save the reminders.

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.


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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.

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.


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.



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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.

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.



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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.

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.


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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 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.



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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.

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


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.


9.12.3 Set System Language

The user interface text can be displayed in English (default), French, German, Italian or Spanish.


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 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 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 217

(DM-2) Clean Wash Bath and Probe Pathway 218

(DM-3) Clean Exterior of Probe 219

(DM-4) Check Probe Alignment 220

(DM-5) Clean and Condition ISE 221

Weekly (WM-1) Clean ISE Reference Housing 222

(WM-2) Clean ISE Sample Port 225

(WM-3) Inspect Air Filters and Clean if Necessary 226

(WM-4) Clean Exterior Surface of Instrument 227

Monthly (MM-1) Rinse Probe and Fluid Lines with Bleach 229

(MM-2) Clean Cap Assemblies and Connectors 230

(MM-3) Calibrate Table Offset, Sample Delay, and Optics 232

Biannual (BM-1) Replace ISE Pump Tubing 233

Unscheduled (UM-1) Replace Printer Paper 235

(As Needed) (UM-2) Replace Printer Ribbon 235

(UM-3) Replace Probe 235

(UM-4) Clean Up Spills 237

(UM-5) Replace ISE Electrodes 238

(UM-6) Replace ISE Peristaltic Pump Roller 240

(UM-7) Replace Fuse 240

(UM-8) Replace Tube Piercing Device 242

(UM-9) Replace Printer 243

(UM-10) Long Term ISE Shutdown 244


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10.1 Daily Maintenance

10.1.1 (DM-1) Remove Condensation from Reagent Compartment

Materials Needed: Lint-free cloth


2 Select Reagents. The messages Pausing the Instrument… and Positioning the sample ring… are briefly displayed before instructions for loading reagents are displayed.

3 When the access indicator is illuminated, open the reagent access cover.


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 32).

6 Replace the reagent tray.



Figure 32. Reagent Compartment (Reagent Tray Removed)

Recessed Camera Lenses


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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


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 surface of the plate that covers the wash bath and around the opening in the plate.

5 Clean the entire probe pathway, including the area surrounding each of the openings.

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 33. Probe Pathway

Wash Probe Bath Pathway


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10.1.3 (DM-3) Clean Exterior of Probe

Materials Needed: Lint-free cloths Alcohol swabs Tweezers (cross locking for easier handling) Distilled or deionized water


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 swab with the tweezers. Wipe the outside of the probe, starting from the top of the probe and wiping downwards to the tip, with the alcohol swab until all traces of debris are removed.

5 Moisten a lint-free cloth with distilled 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.


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 touch 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


2 Select Reagents. The messages Pausing the Instrument… and Positioning the sample ring… are briefly displayed before instructions for loading reagents are displayed.

3 When the access indicator is illuminated, 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.


Note: The syringe module and ISE modules will be automatically primed.


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.


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 12 mL 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 Shake water out of the large opening of the reference housing and pat it dry using a paper towel.

23 Fill a syringe with distilled or deionized water.

24 Place the syringe tip in the reference housing opening containing the black o-ring. Gently push water through the fluid path.


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25 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.

26 Press the tip of the 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.

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.


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 12 mL 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 12 mL service syringe.

6 Pipette 0.5 mL 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 valve.

8 Draw all of the bleach back into the syringe to the 1mL mark on the syringe.

9 With the tubing still connected, pipette 0.5 mL 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 .5 mL distilled or deionized water into the ISE sample port and drawback to the 3 mL mark, add another .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 Remove the silicon rubber tubing from the stainless steel fitting.

11 Carefully replace the measuring chamber inlet tubing on the stainless steel fitting of the ISE sample port.

12 From the Main menu, select Utilities.

13 Select ISE then WASH PORT.

14 Press F10 to start.



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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 system 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, connect the analyzer power cord and 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.


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P/N 701164 Rev 2/03 229

10.3 Monthly Maintenance

10.3.1 (MM-1) Rinse Probe and Fluid Lines with Bleach

Materials Needed: Household bleach solution 2 Empty system diluent container Distilled or deionized water


2 Select Container. The message Preparing containers for access…, followed by The containers are available for access… is displayed and the container access light is illuminated.


4 Remove the system diluent container, using the finger grips to lift it and pull it out of the compartment.

5 Remove the cap assembly and set the diluent aside.

6 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.

7 Install the filled system diluent container in the compartment, close the door, and press F10.



10 Select Miscellaneous to display the Miscellaneous menu.

11 Select Prime Syringe to display the Prime Syringe Diagnostic screen is displayed

12 Select Perform monthly maintenance. The screen displays the first step of the maintenance routine.

13 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.

14 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 and Connectors

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 the Waste Container is removed to be emptied.

Biohazard: Waste material from the ACE which may be classified as biohahardous includes waste fulid 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 F12. When the container access light illuminates, open the container access door and remove the containers.

2 Remove the cap assemblies.

3 Discard the empty CAL-A and system diluent containers.

4 Discard the waste fluid and rinse the waste container as described in Section 5.5.2.

5 Rinse the cap assemblies with distilled water and remove any crystals that may have formed.

6 Dry the cap assemblies with a lint-free cloth before placing them on the appropriate containers.

Cleaning the Cap Connectors

Note: Clean the cap connectors before reinstalling the containers.

1 Moisten a lint-free cloth with distilled water.

2 Locate the cap connectors at the rear of the compartment.

3 Place the moistened cloth over the CAL-A connector. Use a rolling or twisting motion with your fingers to clean around all sides of the connector and remove any crystals or dirt.


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4 Repeat the procedure for the system diluent and waste container connectors.

5 Install the containers.

Note: When all containers have been installed, close the compartment doors and press F10.

Cleaning the CAL-B and Reference Solution Cap Assemblies

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 discard the empty container.

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 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


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.



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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 the Pump Tubes

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

2 Select Troubleshoot then ISE from the Diagnostics menu.


4 Disengage the pump loops from around the pump wheel. Disconnect one pump tube at a time from the old pump plate and reconnect it to the same positions on the new plate.

5 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.

6 Wipe up any spills.

Checking the Installation of New Pump Tubes

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.


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.


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.


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13 Select Prime to calibrate the peristaltic pump speed to the new pump tubing.



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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 Ribbon

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. Disconnect the analyzer power cord.

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.

7 Obtain a new probe.

8 Slide the end of the Allen screws back so they are even with the o-rings.


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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 Connect the analyzer power cord and turn the power on at the UPS.

15 Allow the system to initialize. When the Main menu is displayed, align the probe. Refer to page 220 for details.

Figure 34. Installation of Probe Assembly

Fluid Arm Probe Assembly 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




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.


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.


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.

Note: With CAL-A in the electrodes, the Measurement (VOLTS) for each ion should be a value between –2 and +2 volts.



Note: After replacing the sodium, potassium, or chloride electrode, cleaning, conditioning and calibration must be performed (refer to DM-2).


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10.5.6 (UM-6) Replace ISE Peristaltic Pump Roller

Materials Needed: New peristaltic pump roller





5 Carefully slide the plastic pump plate from its support and slide the pump tubing from the pump roller.

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 the pump tubes as outlined on page 233.


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10.5.7 (UM-7) Replace Fuse

Materials Needed: 250 Volt, 6 amp, slo-blo fuse Forceps or tweezers

WARNING: The power to the system must be OFF before removing and replacing fuses.

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 Locate the small notch at the left side of the fuse holder next to the power cord receptacle (Figure 35). Using a thin screwdriver, pry open the fuse cover.

4 Using a thin screwdriver, pry the fuse holder out of its receptacle.

5 Remove the blown fuse and replace it with a new one.

6 Insert the fuse holder back into the receptacle, making sure it is inserted in the same position that it was removed.

7 Push the fuse holder forward until it snaps securely in place.

8 Reconnect the power cord to the Analyzer.

9 Turn the power on at the UPS.

10 Allow the system to initialize. The Main menu is displayed when initialization is completed.

Figure 35. Location of Fuse Holder

Power Cord Fuse Receptacle Holder


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10.5.8 (UM-8) 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.



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.


P/N 701164 Rev 6/04 243

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.


10.5.9 (UM-9) Replace Printer

Follow the setup instructions provided with the printer. After the printer is connected to the system, refer to section 4.3.3 to set up the printer parameters.


244 P/N 701164 Rev 6/04

10.5.10 (UM-10) Long Term ISE Shutdown

Power to the analyzer should remain ON at all times. To conserve reagents when the system is not being used, the ISE system can be placed in STANDBY mode (see page 175).

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.


P/N 701164 Rev 2/03 245

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.


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 and 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 222.

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 tubing from the pinch valves.



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.


Note: To restart the ISE after a long term shutdown, refer to Section 4 for instructions regarding installation of tubing, electrodes and reagents and Section 9 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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ACE Clinical Chemistry System Operator’s Manual—Troubleshooting

PN 701276 Rev 2/03 249

11. Troubleshooting Procedures

The ACE system is designed to provide reliable and trouble-free operation. However, as with any sophisticated instrumentation, occasional errors or malfunctions may occur.

This section provides a summary of various problems and malfunctions that may occur during operation, possible causes for these events, and recommended actions.

11.1 System Error Messages

An ATTENTION message is displayed and an audible alarm is sounded whenever an event occurs that requires operator intervention (page 144 of Operator’s Manual). Pressing the F9 key silences the alarm and displays details concerning the most recent error (Figure 1).

è Note: Up to 99 items can accumulate. The ATTENTION indicator number remains lit until all events in the list have been resolved.

Information that is displayed for an event may include: • The error category (e.g., Fatal Error or Unrecoverable Error) if applicable • The date and time the error occurred • The primary code and a description of the error • The secondary code and a description of the process that was being

performed at the time of the error • Instructions for resolving or troubleshooting the error event

Figure 1. System Error Message

ACE Clinical Chemistry System Operator’s Manual-Troubleshooting

250 PN 701276 Rev 2/03

11.1.1 Responding to a System Error Message

1 Press F9. The alarm is silenced, and details concerning the error and procedures for resolving it are displayed:

è Note: If there is more than one error, press F5 to display the next error or press F6 to display the previous error.

2 Follow instructions on the screen to resolve the event.

è Note: The instructions may include the use of diagnostic or utilities functions that are designed for both operator and service engineer use. Follow the instructions for procedures that can be handled at an operator level. If the problem can not be resolved, contact your Alfa Wassermann technical service representative for assistance.


PN 701276 Rev 2/03 251

11.1.2 Summary of System Error Messages and Their Resolution

Please refer to Section 11.6 and 11.7. (Reference Pictures and Procedures) where indicated for picture and/or procedures for specific error message resolutions

Error Probable Cause Corrective Action

Active Control Missing 1. A sample cup, cup segment or well segment containing a control sample with pending tests was removed from the instrument.

1. Press Delete to clear the message.

2. Place another sample cup containing the required control into the instrument or delete the remaining tests.

Active Sample Missing 1. A sample cup, cup segment or well segment containing a patient sample with pending tests was removed from the instrument.


2. Place another sample cup containing the required patient sample into the instrument or, (if no additional sample is available), delete the remaining tests (on the requisition).

Air not detected at start of ISE pump speed calibration

1. Clog/ leak in electrodes

2. Pump/ pinch valve tubing leak or crimp

3. Pinch valve bad

1. Use ISE troubleshooting menu ‘Operate Valves and Pump’ to verify Cal B and Cal A can be pumped and that fluid sensor is operational.

2. Refer to Section 11.7.1, Troubleshooting Procedure B

Analysis Chamber Temperature Control Failure

1. The analysis chamber temperature has been too high for too long and the temperature control system for the chamber is disabled.

1. Select Initialize instrument from the Diagnostics menu to clear message.

2. Contact Customer Solution Center.

Analysis Chamber Temperature Too High

1. The analysis chamber temperature is too high.


2. Clean air filter located below analyzer.

3. Lower room temperature if above 90° F.

4. If the problem persists contact Customer Solution Center

Analysis Chamber Temperature Too Low

1. The analysis chamber temperature is too low.

2. Hopper or hopper cables not seated properly


2. Reseat hopper and cables (See Section 11.6.1)

3. If the problem persists contact Customer Solution Center


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Analyzer DC motor Error

1. Broken or mis-inserted cuvette in cuvette wheel

1. Power down system. Remove hopper. Check cuvette wheel and hopper for broken or mis-inserted cuvettes (Section 11.6.2)

Bottle Short 1. There is not enough reagent in a bottle to perform the remaining requested tests.

2. An old bottle was detected and declared invalid.

3. Tube popped off Syringe Module


2. Press F12 to display the Access menu and perform the necessary steps to open the reagent compartment access cover.

3. Remove the empty bottle from the reagent tray and replace it with a new one.

4. Close the reagent compartment access cover and press F10.

5. Check Syringe Module tubing. (Section 11.6.5)

Calibration Failure 1. A calibration for a Photometric test failed.


2. Review the printout and repeat the calibration.

Calibrator A Container Empty (ISE)

1. The CAL-A container is empty.

1. Press F12 to display the Access menu, select Containers, then open the container access door.

2. Remove the empty container from the compartment and replace it with a new one.

3. Close the container access door and press F10.

4. The message automatically clears.

Calibrator B Container Empty (ISE)

1. The CAL-B container is empty.

2. CAL-B cap on too tight





5. Loosen CAL-B cap slightly

Calibrator Short 1. There is not enough calibrator available to perform the tests that have been ordered.


2. Press F12 to display the Access menu. Perform the necessary steps to fill a short cup (refer to section 7.1.4).

3. Place another sample cup containing calibrator into the instrument.


PN 701276 Rev 2/03 253


Calibrator Lifetime Exceeded

1. A calibrator that has pending tests has been on the instrument longer than the amount of time that is permitted and is thus considered expired.


2. Press F12 to display the Access menu and select Cup, Change .

3. Select the desired cup, open the segment access cover when prompted, and replace the expired cup with another sample cup containing the calibrator.

4. Place another sample cup containing calibrator into the instrument.

Calibrator or Corrector Cup Missing

1. A sample cup, cup segment or well segment containing a calibrator or corrector with pending tests was removed from the instrument.


2. Place another sample cup containing the required calibrator or corrector into the instrument or delete the remaining tests.

Control Lifetime Exceeded

1. A control sample that has pending tests has been on the instrument longer than the amount of time that is permitted and is thus considered expired.



3. Select the desired cup, open the segment access cover when prompted, and replace the expired cup with another sample cup containing the control sample.

4. Place another sample cup containing the control into the instrument.

Control Short 1. There is not enough control sample available to perform the tests that have been requested.


2. Press F12 to display the Access menu. Perform the necessary steps to fill a short cup (refer to section. 7.1.4).

3. Place another sample cup containing control into the instrument.

Correction Failure 1. A calibration correction test failed to correct.


2. Review the printout and repeat the correction.

Cuvette Check Failure

1. The number of consecutive cuvettes with a transmission level below the acceptable limit has exceeded the set limit.

1. Select Initialize instrument from the Diagnostics menu to clear the message.

2. Select Diagnostics, ‘Miscellaneous’ menu. Prime syringe 3x

3. Calibrate the optics if the problem persists (see Maintenance section).


254 PN 701276 Rev 2/03


Cuvette Check Warning 1. An unexpectedly high frequency of empty cuvettes with percent transmission levels below the acceptable limit have been detected.


2. Select Diagnostics, ‘Miscellaneous’ menu. Prime Syringe 3x

3. Calibrate the optics if the problem persists (see Maintenance section).

Cuvette follower motor unable to find home sensor

1. Mis-inserted cuvette

2. Bad internal fuse

1. Power down system. Check slot directly under follower for mis-inserted cuvette (See Section 11.6.9)

2. Call Solutions Center for support.

Cuvette follower touched something unexpectedly

1. Mis-inserted/ broken cuvette

1. Power down system. Check slot directly under follower for mis-inserted/ broken cuvette. (See Section 11.6.9)

Cuvette Hopper Empty 1. There are no cuvettes in the hopper.

1. Press F12 to display the Access menu and select Hopper.

2. Refill the hopper with cuvette and press F10.

3. The message will automatically clear when cuvettes are detected in the hopper.

Cuvette Hopper Low 1. There are only 1 to 20 cuvettes remaining in the cuvette hopper.

1. Press F12 to display the Access menu and select Hopper.

2. Refill the hopper with cuvettes and press F10.

3. The message will automatically clear if more than 20 cuvettes are detected in the hopper.

Cuvette inserter motor unable to find home sensor

1. Cuvette mis-inserted/ broken in hopper.

2. Cuvet stuck in cuvet wheel

1. Power down system. Remove hopper, verify cuvettes are loaded properly. (See Section 11.7.7)

2. Check cuvette wheel for any mis-inserted cuvettes. (See Section11.6.2)

Cuvette inserter motor unable to find position

1. Cuvette mis-inserted/ broken in hopper

2. Cuvette stuck in cuvette wheel

1. Power down system. Remove hopper, verify cuvettes are loaded properly (See Section 11.7.7)

2. Check cuvette wheel for any mis-inserted cuvettes (Section 11.6.2)


PN 701276 Rev 2/03 255


Cuvette Waste Box Full 1. The cuvette waste box is full of cuvettes.

2. BIOBAG not securely on waste box.

3. Sensors dirty

1. Open the waste box access door and remove the waste box from the compartment (See Section 11.7.6)

2. Remove the BIOBAG and dispose of if properly.

3. Insert a new BIOBAG into the waste box, secure to box, return the waste box to the compartment and close the door.


5. Clean Waste Box sensors.( Section 11.7.6)

Diluent Container Empty 1. The system diluent container is empty.





Duplicate Bottle Label 1. The system has detected two reagent bottles with the same label.


2. Press F3 to display the Status menu and select Reagent Tray.

3. Identify the duplicate bottles.

4. Press F12 to display the Access menu, select Reagents, then open the reagent compartment access cover.

5. Remove both bottles and place one new bottle of the reagent in the tray.

6. Close the access cover and press F10.

Error homing analyzer DC motor 1. Obstruction preventing cuvette wheel from spinning

1. Reboot system

2. Remove hopper and check cuvette wheel for broken/ mis-inserted cuvettes that might prevent wheel spin. (Section 11.7.7)

Hopper horizontal motor unable to find home sensor

1. Cuvette broken or mis inserted in hopper

1. Power down system. Check hopper magazine for any mis-inserted cuvettes.

Hopper horizontal motor unable to find position

1. Cuvet tebroken or mis-inserted in hopper

1. Power down system. Check hopper magazine for any mis-inserted cuvettes. (Section 11.6.9)


256 PN 701276 Rev 2/03


ISE Calibration Failure (ISE) 1. A calibration for one or more channels of the ISE failed.


2. Review the printout and repeat the calibration.

ISE Control Sample Cancelled (ISE)

1. The container access door was opened without using the proper access procedure while the ISE was processing a control sample.


2. Testing of the control sample was cancelled so the sample will be rerun.

ISE Patient Sample Cancelled (ISE)

1. The container access door was opened without using the proper access procedure while the ISE was processing a patient sample.


2. Testing of the patient sample was cancelled so the sample will be rerun.

Missing Well Seglet 1. The instrument detected a well segment that does not contain three seglets and has been assigned a status of DONE.


2. Press F12 to display the Access menu, select Segment, Remove , then open the segment access cover.

3. Remove all segments with a status of DONE.

4. Close the cover and press F10.

5. Press Esc until the Main menu is displayed.

No Control Result 1. A calculation error was obtained for a control result.

1. Display the control requisition in question.

2. Manually rerun the test.

3. The message is cleared.

No fluid detected at start of ISE electrode load

1. Clog in ISE system

2. Clog in probe

3. Faulty ISE tubing

1. Use ISE troubleshooting menu ‘Operate Valves and Pump’, verify sample, Cal A and Cal B can be pumped.

2. Verify operation of fluid sensor.

4. Refer to Section 11.7.1, Troubleshooting Procedure C

No Patient Result 1. A calculation error was obtained for a patient result.

1. Display the patient requisition in question.

2. Manually rerun the test.


No Requisition for Tube 1. A requisition does not exist for the tube that was placed in the instrument.

1. Remove the tube. The message will clear automatically.

2. Create a requisition for the tube and then place the tube in the instrument.


PN 701276 Rev 2/03 257


No Wells Available 1. The requested test or action requires an empty well, but none are available.

1. Press F12 to display the Access menu.

2. Select Segment, Place, Well .

3. Open the segment access cover.

4. Place a well segment with 3 clean seglets into the instrument.

5. Close the cover and press F10.

6. The message will automatically clear when the new well segment is detected.

Old Bottle 1. The system has detected a reagent bottle that had previously been in the reagent tray.



3. Identify the old bottle.


5. Remove the old bottle and place a new bottle of the reagent in the tray.


Panic Result 1. A test result is beyond the panic limit that has been configured for that test.

1. Follow the instructions in section 7.3.4


Panic Rerun 1. An error occurred during testing that will not allow the system to report the result, however the expected result exceeds the high panic limit for that test.


2. The system automatically dilutes and reruns the sample.

Performance Diagnostic Bottle Missing

1. A reagent bottle that is required to perform a diagnostic test is not in the reagent tray.


2. Place a bottle of the missing reagent in the tray.


4. If the bottle can not be placed in the tray, cancel the diagnostic test.

Position sensor not seen at end of STEP cover movement

1. Cover movement faulty 1. Re-Initialize system

2. Clean cover rails (Section 11.6.7-8)

3. Check that cover is on properly


258 PN 701276 Rev 2/03


Probe didn’t touch alignment plate when it should have

1. Mis-aligned/ clogged probe

2. Tube popped off syringe

3. Dirty washplate

4. Transfer Arm cable

1. Perform probe alignment/ clog check (Sections 11.7.4, 11.7.5)

2. Check syringe module tubing for tight fit (Section 11.6.5)

3. Perform washplate cleaning (Section 11.7.3)

4. Reseat Transfer Arm cable (Section 11.6.6)

Probe touched alignment plate unexpectedly


2. Tube popped off syringe

3. Dirty washplate

4. Transfer Arm cable


2. Check syringe module tubing for tight fit (Section 11.6.5)


4. Reseat Transfer Arm cable (Section 11.6.6)

QC Check Failure 1. A test for a control failed one of the enabled QC Checks.


2. Review the Control Requisition Report and Levey-Jennings plot for the control to determine which rule failed.

3. Perform corrective action as needed.

Reagent Chamber Temperature Control Failure

1. The Reagent chamber temperature has been too high for too long and the temperature control system for the chamber is disabled.



Reagent Chamber Temperature Too High

1. The segment or reagent access door may have been left open for too long.

2. The reagent chamber coolers may be malfunctioning.

1. Clean the air filter on the right side of the analyzer.

2. If the problem persists contact Customer Solution Center.

3. The message will clear when the temperature has returned to the required range.

Reagent Chamber Temperature Too Low

1. Reagent chamber temperature is too low perhaps due to a malfunction of reagent chamber thermistor.

1. Contact Customer Solution Center if the problem persists.

2. The message will clear when the temperature has returned to the required range.


PN 701276 Rev 2/03 259


Reagent Lifetime Exceeded 1. The on-board working lifetime of a reagent that is loaded in the Reagent Tray has expired.



3. Identify the expired reagent.


5. Press F12 to display the Access menu, select Reagent, then open the reagent compartment access cover.

6. Remove and replace the expired reagent, close the access cover and press F10.

Reagent Lot Change 1. The system has detected a change in the lot number of a reagent.


2. Perform a calibration for the test using the reagent if that test requires calibration.

Recoverable System Error 1. A recoverable system error has occurred.

1. Press Delete to clear the message if applicable.

OR:

Follow the instructions on the display.

Sample Lifetime Exceeded 1. A patient sample that has pending tests has been on the instrument longer than the amount of time that is permitted and is thus considered expired.



3. Select the desired cup, open the segment access cover when prompted, and replace the expired cup with another sample cup containing patient sample.

4. Place another sample cup containing patient sample into the instrument.

5. If no additional sample is available, delete the remaining tests on the requisition.

Sample Ring Mismatch 1. One or more of the segments on the sample ring are loaded differently than the instrument expected them to be.


2. Press F3 to display the Status menu and select Sample Ring.

3. Identify the segment(s) that are improperly loaded.

4. Press F12 to display the Access menu and select Segment, Remove .

5. Remove the segment(s) in question.


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Sample Short 1. There is not enough patient sample available to perform the tests that have been requested.

2. Bubble in cup bottom


2. Check cup for bubble

3 Press F12 to display the Access menu. Perform the necessary steps to fill a short cup (refer to section 7-1-4).

4. Place another sample cup containing patient sample into the instrument.

5. If no additional sample is available, delete the remaining tests on the requisition.

Time to Run Control 1. It is the time of day configured in the QC Reminder to run controls.


2. Run the controls.

Toxic Rerun 1. An error occurred during testing that will not allow the system to report the result, however the expected result exceeds the toxic limit for that test.


2. The system automatically dilutes and reruns the sample.

Toxic Result 1. A test result is beyond the toxic limit that has been configured for that test.

1. Follow the instructions in section 7.3.4


Transfer arm rotation motor unable to find home


2. No arm movement

1. Re-Initialize system


3. Exercise Transfer Arm in ‘Verify Modules’

Transfer Arm Temperature Control Failure

1. The transfer arm temperature has been too high for too long and the temperature control system for the arm is disabled.


2. Contact Customer Solution Center

Transfer Arm Temperature Too High

1. The temperature of the transfer arm is too high perhaps due to a malfunction of the transfer arm heater



Transfer Arm Temperature Too Low

1. The temperature of the transfer arm is too low due to a malfunction of the transfer arm heater or cable.

1. Select Initialize instrument from the Diagnostics menu to clear the message, reseat Transfer Arm cable (Section 11.6.6)



PN 701276 Rev 2/03 261


Transfer Arm vertical motor unable to find position

1. Mis-aligned or bent probe

2. Wet reagent evap caps

1. Re-initialize

2. Perform probe alignment (Section 11.7.5)

3. Check that evaporation caps are dry

Tray motor unable to find position 1. Dirty/ wet tray

2. Dirty/ wet sensor

1. Remove tray. Clean/ dry position slots on tray bottom (Section 11.6.3)

2. Remove tray. Clean/ dry position sensor (Section 11.6.4)

Tube Short 1. The liquid level was not detected.


2. Transfer the sample to a sample cup and load it into the instrument.

Unable to find center frequency 1. Probe mis-aligned, bent, or clogged

2. Washplate dirty

3. Syringe tubing off.

1. Perform probe alignment, clog check (Sections 11.7.4, 11.7.5)


3. Check syringe module tubing (Section 11.6.5)

Unable to move tray motor out of home sensor

1. Reagent tray not in analyzer

2. Dirty, wet sensor

1. Place reagent tray in analyzer

2. Clean, dry sensor (Section 11.6.4)

Unable to read Tube Label 1. The label that is on the tube is illegible.

2. Scanner is enabled, but no scanner is present.

1. Remove the tube. The message will clear automatically.

2. Place the tube in the instrument again, verifying that the positioning of the tube is correct.

3. If the label still can not be read, use patient requisition to place tube or sample cup.

Unrecoverable System Error 1. An unrecoverable system error has occurred.

1. Select F7 if available.




262 PN 701276 Rev 2/03


Volume Too Large.. Bottle, sample cup

1. The system has detected an increase in the volume of a reagent bottle or sample cup



3. Identify the bottle or cup in question.


5. Remove the bottle or cup in question and place a new bottle or cup of the reagent or sample in the tray.


Volume Unexpected.. Bottle, sample cup

1. The volume in a reagent bottle or sample cup is different than the system expected it to be without having the Reagent Compartment opened.




4. Inspect the bottle or sample cup for foaming, a wet Evap-cap or excessive evaporation and replace if necessary.


Waste Container Full 1. The liquid waste container is full of fluid.

2. Old bottle too dark for sensor light to pass through.

3. Sensors dirty.


2. Remove the waste container from the compartment and empty it, or replace if not clear (refer to section 5.5.2).

3. Clean sensor.

4. Reinstall the waste container.



Wet Stopper 1. Liquid on the stopper has tripped the liquid level sensor.

1. Remove the stopper and reintroduce the tube.


PN 701276 Rev 2/03 263

11.2 System Operation Troubleshooting

This section provides basic hardware troubleshooting procedures. The probable cause and corrective action to take are summarized for each type of problem.

è Note: Contact your Alfa Wassermann solution center representative for assistance.

Important: When turning on power to the computer, be sure that the system power (the UPS power) is turned on before the power to the computer is turned on.

Problem Probable Cause Corrective Action

The UPS is not operating.

1. The power cord is disconnected.

2. The wall receptacle is faulty.

1. Push in the power plug at the wall outlet.

2. Press the UPS overload reset button on the rear of the UPS and press the UPS power button.

3. Check that the red fault LED at the rear of the UPS is on. If the LED is on, the outlet is faulty.

4. Plug the UPS into a good outlet.

5. Contact an electrician to repair the outlet.

The computer is not operating.

1. The power switch is off.


3. The cord is faulty.

1. Verify that the computer power is on.

2. Push in the power plugs at the UPS and the computer.

3. Connect the computer power cord to a known good wall outlet to verify that the outlet is not the problem.

4. Connect using the analyzer power cord. If the computer starts, replace the computer power cord with a new one.

The printer is not operating.




4. The printer is not on-line.

1. Verify that the printer power is on and that the printer is on-line.

2. Push in power plugs at the UPS and the printer.

3. Connect the printer power cord to a known good wall outlet to verify that the outlet is not the problem.

4. Connect using the analyzer power cord. If the printer starts, replace the printer power cord with a new one.


264 PN 701276 Rev 2/03


The monitor is not operating. 1. The power switch is off.



4. The brightness and contrast controls are not turned up.

1. Check that the monitor power is on and the brightness & contrast controls are turned all the way up.

2. Push in the power plugs at the UPS and at the monitor.

3. Connect the monitor power cord to a known good wall outlet to verify that the outlet is not the problem.

4. Connect using the analyzer power cord (if monitor power cord disconnects from back of monitor). If the monitor starts, replace the monitor power cord with a new one.

The analyzer is not operating.




4. There is a blown fuse.

1. If the fans are off, check that the analyzer power is switched on. If the analyzer fans are on, contact Customer Solution Center.

2. Push in the power plugs at the UPS and at the analyzer.

3. Check the main fuse at the left rear of the analyzer (when facing the rear of the analyzer) and the fuse inside the AC power module drawer

4. Connect the analyzer power cord to a known good wall outlet to verify that the outlet is not the problem

5. Connect using the computer power cord and determine if the fans start when power is turned on. If the fans start, replace the analyzer power cord with a new one. If the fans do not come on, contact Customer Solution Center.

The ISE is not operating. 1. The ISE is not enabled. 1. If the message ISE detected followed by not enabled is displayed during system bootup, the ISE must be enabled. Refer to the Installation section for instructions. (Even if Enable is selected, select again and press F10.)

2. If the ISE Enable option can not be highlighted in the Hardware Setup screen, contact Customer Solution Center.


PN 701276 Rev 2/03 265


The printer power light is illuminated, but the printer does not print properly.

1. The printer is out of paper.

2. There is a paper jam.

3. Character printing is set too light.

4. The ribbon may be exhausted.

1. Shut down and then restart the printer.

2. Check for printer alarms (consult the printer Operator’s Manual for information on printer alarms and their resolution).

3. Verify that the tension lever is set at the correct paper setting.

4. Replace the ribbon cartridge.

5. If the printer prints erroneous characters, verify that the printer parameters are set correctly.

Temperature of the reagent compartment is out of range, or the reagent compartment is icing up.

1. Reagent temperature is not enabled.

1. Verify that reagent temperature is enabled (refer to the Configuration section).

2. If needed, contact Customer Solution Center.

A patient sample tube is not recognized when it is placed in the STEP module.

1. The tube is empty.

2. The proper patient requisition is not displayed.

1. Verify that there is sufficient fluid in the tube and that the proper patient requisition is displayed, then place the tube in the STEP module again.


The STEP does not read the barcode label on the tube.

1. The label is not facing to the left.

2. The label is damaged.

3. The barcode scanner is not enabled or not present.

1. Verify that the tube barcode label is facing towards the left (towards the indicator panel) while the tube is inserted.

2. Verify that the label is placed on the tube properly and is not damaged.

3. Verify that the barcode scanner is enabled (refer to the Configuration section).

4. Try a different barcode-labeled tube.



266 PN 701276 Rev 2/03


The Cuvette Waste Box Full message is displayed, but the waste box is not full.

1. The waste bag is not contacting the outer walls of the waste bin.

2. The waste box is not in place.

3. The sensors are blocked.

1. Verify that the waste bag is folded over the edge of the waste box and that the bag is fully open inside the bin.

2. Place a rubber band on the top of the waste box & over the bag to keep the bag from protruding up over the top edge of the bin.

3. Check that cuvettes are not catching on the bag lip and blocking the sensor.

4. Clean the sensors (Refer to Appendix A, Cuvette waste sensor procedure)


Potassium values are low, and/or the potassium Cal Slope is significantly lower after replacing CAL-B.

1. CAL-B has been contaminated with Reference Solution salts.

1. Clean container caps of all salt deposits.

2. Carefully wipe CAL-B aspirator with a Kimwipe moistened with distilled or deionized water, then dry.

3. Replace the CAL-B container, being careful not to contaminate the fluid or cap assembly, especially the aspirator.

A Cal Slope calibration error is observed for chloride.

1. The concentration of CAL-B has increased due to evaporation.

1. Replace the container of CAL-B.

An ISE SAT error occurs for sodium, potassium and chloride during the first calibration following removal of an electrode.

1. The measuring chamber is not properly locked into position.

1. Check the positioning of the measuring chamber, verifying that it is all the way back and that the clamp is in the closed position.

Noise is reported in the ISE calibration report and the patient ISE results.

1. The Electrodes require preconditioning.

2. There is a possible air leak into CAL-A.

3. There is a problem with the reference electrode or housing.

1. Check the raw data for the sample. If there is occasional noise below 200 and less than five samples are run per day, precondition the electrodes with serum after cleaning .

2. If noise is observed only for CAL-A and the level is higher than 200 or SAT, check the CAL-A aspirator for cracks.

3. If there is high noise on both calibrator and sample, check for fluid in the reference housing. If it is dry, the reference electrode may need replacing. Check the fluid drip rate, and check for a clog in the reference housing capillary.


PN 701276 Rev 2/03 267

11.3 Workstation Troubleshooting

Workstation errors involve the system computer. When a workstation error is detected, a bold red message (for example, MATH, DOWNLOADING or TIMEOUT) is displayed on the screen.

Workstation errors are unrecoverable. Press any key while a workstation error is displayed to exit to DOS.

è Note: To return the system to normal operation, reboot the system by turning the power off and then back on at the UPS.

11.4 System Power Failure

If power to the system is lost, the UPS provides battery backup for five minutes so that tests in progress to be completed. If power is not restored within the five minute period, any incomplete tests are cancelled.

1 Press F9. The alarm is silenced, and details concerning the error and procedures for resolving it are displayed:

è Note: If power is not restored within five minutes, a workstation error results and the system must be rebooted.


268 PN 701276 Rev 2/03

11.5 Advanced Troubleshooting

è Note: Advanced troubleshooting is generally performed under guidance of an Alfa Wassermann Customer Solution Center representative, unless specified as a part of an operator-performed procedure or as a response to an error event.

The Troubleshoot command (on the Diagnostics menu) contains functions to aid during troubleshooting:

11.5.1 Analyzer

Analyzer displays a menu containing commands to troubleshoot the analyzer module:

Command Purpose

Analyze Executes an analyzer measurement cycle and displays the transmission (or absorbance) and the measurement CV of the specified cuvettes and optical channels (wavelength).

Display measurement data

Displays raw photodetector measurement data resulting from the previous measurement cycle.

Edit curve list Allows selection of cuvets to be analyzed, type of measurement (absorbance or fluorescence) and wavelength for absorbance measurements.

Miscellaneous parameters

Allows editing of analyzer troubleshooting parameters.

Flash lamp Allows testing of the flash lamp.

Photodetector voltages

Displays static photodetector measurements.

Supply voltages Displays analyzer power supply sense voltages.


PN 701276 Rev 2/03 269

11.5.2 Sensors

Sensors displays the state of every instrument sensor. The display is updated approximately five times a second:

è Note: Highlighted states are “true” or “open”.

11.5.3 Motors

Motors displays a menu that allows each motor to be operated:

Command Purpose

Transfer Arm Operates the probe transfer arm.

Syringe Operates the syringe pump.

Reagent Tray Rotates the reagent tray.

Hopper Operates the cuvet loading system.

Analyzer Operates the cooling fans in the analyzer.

STEP Operates the Sample Tube Entry Port (STEP).

è Note: The ISE pump motor is controlled by a separate function.


270 PN 701276 Rev 2/03

11.5.4 Reagent Tray

Reagent tray displays a menu containing commands to display reagent label information and the location of sample cups and well segments on the reagent tray:

Command Purpose

Reagent inventory Displays the label of each bottle in the reagent tray.

Segment inventory Displays a representation of the sample cups in each cup segment and the location of well segments in the tray.

11.5.5 Tube Entry

Tube entry displays commands for troubleshooting the STEP:

Command Purpose

Pierce tube Lowers the tube, reads the label, (where applicable), pierces the tube, returns the tube and displays the label.

Read tube label As above, except the tube is not pierced.

Move motors Displays the state of each sensor and allows high-level operation of each motor.

Position tube Lowers the tube into position and leaves it there.

Scan tube label Scans a positioned tube and displays the label.

Display label signature

Displays a graphical representation of the video signal received from the barcode scanner.


PN 701276 Rev 2/03 271

11.5.6 ISE

ISE displays commands for troubleshooting the ISE module:

Command Purpose

Operate valves/pumps

Operates the pump and the individual valves.

Prime Fills supply lines with CAL-A and CAL-B.

Graph measurements

Generates a graphical display of electrode measurement potentials versus time for the last ISE sample or calibration.

Wash sample port Allows the sample port to be washed.

Empty sample port Empties the sample port.

Maintenance Allows the operator to perform maintenance functions.

Standby Places the ISE in Standby mode.

Display PS voltages

Displays the ISE module power supply sense voltages.

11.5.7 Temperature Monitor

Temperature displays a screen that provides information regarding the status of the temperature control system. The information is updated five times per second.

11.5.8 Capacitive Sensor

Capacitive Sensor command displays a screen that allows the autocalibration sequence for the transfer arm capacitive sensor to be executed. The results of the calibration are then displayed.

11.5.9 Probe

Probe-Press F1 to display a troubleshooting guide for probe errors.

11.6 Figures

Figure 11.6.1 Hopper Module: J12 and J17 Figure 11.6.2 Foam Stripping around reaction wheel with hopper removed Figure 11.6.3 Reagent Tray- encoder slots and index (home) flag


272 PN 701276 Rev 2/03

Figure 11.6.4 Index and Position sensors Figure 11.6.5 Syringe Pump Module Figure 11.6.6 Fluid Arm PCB, mounting screws and ribbon cable Figure 11.6.7 STEP cover rails. Left Figure 11.6.8 STEP cover rail, right Figure 11.6.9 Hopper Module PROCEDURES ISE FLUIDICS TROUBLESHOOTING BY ATTENTION CODES Overview Listing by Attention Code A. ISE Cal B Empty B. Liquid Sensor Not Changing C. No Fluid Detect At Start of ISE Load D. ISE Cal A Empty E. Unable to Calibrate ISE Pump Speed 1. Cleaning ISE Sample Port Procedure 2. Washplate Cleaning Procedure 3. Procedure for Testing and Removing Probe Clogs 4. Probe Alignment Procedure 5. Cuvette Waste Box Sensor Cleaning 6. Removal and Replacement of the ACE Hopper Module

PN 701276 Rev 2/03 273

Figure 11.6.1 Hopper Module / J12, 12 pin red connector, J17, connectors on hopper pcb

Figure 11.6.2 Main Deck / Foam stripping around reaction wheel with hopper module removed

Hopper pcb lowered from

Hopper Module Frame

Hopper Module pcb mounted on left side of Hopper Module

1 of 3 Hopper pcb Press Release Locks

J17

JI2

Top Left Middle View of Main

Deck with Hopper Module removed

Reaction Wheel

Foam Stripping

Slot to Cuvette Discard Bin


274 PN 701276 Rev 2/03

Figure 11.6.3 Reagent Tray / Encoder slots & index (home) flag

Figure 11.6.4 Index & Position Sensors

Top View of Reagent Compartment with Reagent Tray removed

Tray Gear

Bottom View of Reagent Tray

Index Flag (flag outlined in white)

Tray Spindle Receptacle

Top View of Reagent Compartment with Reagent Tray removed

Index Sensor

Position Sensor

Inner Label Camera

PN 701276 Rev 2/03 275

Figure 11.6.5 ACE Syringe Pump Module Assembly

Syringe pump

Tubing out to Probe Assembly

Tubing from System Diluent to Syringe

Pump

Tubing out to Waste

Pump

EStepper Motor

Pump Valve


276 PN 701276 Rev 2/03

Figure 11.6.6 Fluid Arm pcb / Mounting screws & ribbon cable connector

Figure 11.6.7 and 11.6.8 STEP Cover removed from STEP module with view of cover rails

Figure 7. Left STEP Cover Rail Figure 8. Right STEP Cover Rail

Fluid Arm pcb

Insulator is placed between pcb & Shield

Shield is placed over Insulator

and pcb

MOUNTING SCREWS SECURE SHIELD, INSULATOR & PCB IN PLACE

Ribbon Cable Connector

Shield & Insulator may not be installed on older systems

Top Front View of Analyzer with STEP Cover removed

Left STEP Cover Rail

Right STEP Cover Rail

PN 701276 Rev 2/03 277

Figure 11.6.9 ACE Hopper Module Assembly

Cuvette Sleeve or Cartridge Loading Port

Tops of Loaded Cuvettes

Cuvette Follower

Ground Cable or Wire Connection

One of Three Pinch Connectors

Circuit Board

Screw

Screw


278 PN 701276 Rev 2/03

ISE OVERVIEW

Reference Solution with Cap and Tubing Assembly

Measuring Chamber

Pump Tubing Assembly

Gray Liquid Sensor Cable

Sample Cal A and Waste Stainless

Pipes From Left to Right Located on Side and Back

Wall

Sample Cal A, Cal B and Air Valves From

Left to Right

Mounted Electrodes

ISE Vent Bottle

Manifold

Troubleshooting Procedures

PN 701276 Rev 2/03 279

11.6 Troubleshooting Procedures

11.7.1 ISE TROUBLESHOOTING BY ERROR

Purpose: To systematically troubleshoot ISE problems using attention codes.

Materials Needed: Service syringe

Tubing (if necessary)

Deionized water (DI)

A. CAL B Empty • Use Instrument Access to verify if CAL B is low or empty. • If not low, check the following: • Missing any of the five electrode O-rings • Fluid Sensor not plugged in • Electrode Holder not closed • CAL B cap vent may be stuck, loosen cap • Air bubbles or leaks

If the above items have been checked, refer to Troubleshooting Procedure A.

B. Liquid Sensor Not Changing, Air Not Detected at Start of ISE Load

• Verify Fluid Sensor is plugged in and seated properly. • Use ISE TROUBLESHOOT menu “Operate valves/pump” to verify flow of CAL A, CAL B and

AIR. If the above items have been checked, refer to Troubleshooting Procedure B. C. No Sample Detected at Start of ISE Electrode Load • Use ISE UTILITIES menu and observe for 6 or more air chops of Wash Solution entering the Measuring

Chamber during the WASH PORT cycle. • Check for disconnected tubing at the Syringe Module. • Check for air in the Syringe. • Check for a clogged Fluid Probe. If the above items have been checked, refer to Troubleshooting Procedure C. D. CAL A Empty • Use Instrument Access to verify if CAL A is low or empty. • If not low, check if the CAL A Container Cap Assembly is cracked or broken off. If the above items have been checked, refer to Troubleshooting Procedure D.


280 PN 701276 Rev 2/03

E. Unable To Calibrate Pump Speed • Recalibrate the ISE Liquid Sensor. If the above items have been checked, refer to Troubleshooting Procedure E.

ISE CAL B Empty

Troubleshooting Procedure A

Fig. 2

Troubleshooting Procedure 1. Remove the CAL B tubing that passes through the CAL B valve. 2. Disconnect the CAL B tubing at the manifold position. 3. Connect the Service Syringe to the free end of the CAL B tubing. 4. Try to aspirate CAL B into the syringe. 5. If CAL B cannot flow or resistance is felt, there is a clog or air leak in the tubing. Replace CAL B tubing. 6. If liquid enters the syringe, refer to Troubleshooting Procedure B.

REMOVE CAL B TUBING FROM CAL B VALVE AND FITTING.

ATTACH SYRINGE TO FREE END OF

CAL B TUBING.

(STEPS 1-4)


PN 701276 Rev 2/03 281

ISE

Liquid Sensor Not Changing, Air Not Detected at Start of ISE Load

Troubleshooting Procedure B

Troubleshooting Procedure 1. Remove the Waste tubing from the pipe marked WASTE and place the free end into a small container. 2. Prime the ISE. If the error clears, the clog is under the Main Deck. 3. If not, remove the Waste Transport tubing from the white Waste Outlet fitting. 4. Fill the Service Syringe with DI water. Using a small piece of tubing, attach the water-filled syringe to the Waste Outlet

fitting. 5. Try to push water through the Measuring Chamber. 6. If water flows, check for missing O-rings, cut or disconnected tubing. 6. If no water leaks are detected, remove the Inlet tubing at the manifold position and attach the water-filled syringe to the

free end, stopping if any back pressure on syringe. 7. Try to push air through the Measuring Chamber. 8. If no water flows, there is a clog in an Electrode, the left or right fitting of the Chamber or the Inlet tubing. Flush out to

clear clog, stopping if any back pressure on syringe. 9. If water flows, reattach the air-filled syringe to the free end of the Waste Transport tubing and remove the Pump tubing

from around the Peristaltic Pump Rollers. 10. Try to push water through the Waste Transport tubing.

REMOVE PUMP TUBING FROM AROUND THE PUMP ROLLERS.

(STEP 10)

REMOVE INLET TUBING AND ATTACH SYRINGE FILLED

WITH AIR. (STEPS 7-9)

REMOVE WASTE TUBING AND PLACE FREE END INTO A CUP.

PRIME THE ISE. IF ERROR CLEARS, CLOG IS

UNDER ACE MAIN DECK. (STEPS 1-2)

REMOVE WASTE TRANSPORT TUBING FROM WHITE FITTING.

ATTACH SYRINGE FILLED WITH AIR.


282 PN 701276 Rev 2/03

11. If no water flows, there is a clog in the Waste Transport tubing, Pump tubing or Waste tubing. Remove each piece of tubing and flush out to clear clog.

12. Reconnect all tubing back to their original correct positions and reprime the ISE. 13. If all troubleshooting steps pass, call the Customer Solution Center

ISE No Sample Detected at Start of ISE Load

Troubleshooting Procedure C

Troubleshooting Procedure

1. Remove the SAMPLE tubing that passes through the SAMPLE valve. 2. Disconnect the SAMPLE tubing at the manifold position. 3. Connect the Service Syringe to the free end of the SAMPLE tubing. 4. Try to aspirate air or sample into the syringe. 5. If no air or liquid enters the syringe or resistance is felt, there is a clog in the SAMPLE tubing or the ISE Port. Perform

weekly maintenance (WM-2) Clean ISE Sample Port or replace SAMPLE tubing. 6. If air or liquid enters the syringe, refer to Troubleshooting Procedure B.

REMOVE SAMPLE TUBING FROM SAMPLE

VALVE AND FITTING.

ATTACH SYRINGE TO FREE END OF SAMPLE

TUBING.


PN 701276 Rev 2/03 283

ISE CAL A Empty

Troubleshooting Procedure D

Troubleshooting Procedure

1. Remove the CAL A tubing that passes through the CAL A valve. 2. Disconnect the CAL A tubing at the manifold position. 3. Connect the Service Syringe to the free end of the CAL A tubing. 4. Try to aspirate CAL A into the syringe. 5. If CAL A cannot flow or resistance is felt, there is a clog in the CAL A tubing or the CAL A in-line filter. Replace CAL

A tubing or CAL A Container Cap Assembly. 6. If air or liquid enters the syringe, refer to Troubleshooting Procedure E.

REMOVE CAL A TUBING FROM CAL A VALVE AND FITTING.

ATTACH SYRINGE TO FREE END OF CAL A TUBING.

(STEPS 1-3)


284 PN 701276 Rev 2/03

ISE Unable to Calibrate Pump Speed

Troubleshooting Procedure E

Troubleshooting Procedure 1. Attention message occurs when the liquid sensor does not see a change from liquid to air in the allotted time frame.

Either the Liquid Sensor needs calibration, the Measuring Chamber Inlet tubing is not exactly 2.5” in length, or the Sample Transport tubing is not exactly 8.5” in length. Check and replace tubing if necessary.

2. Remove the AIR INLET tubing that passes through the AIR valve. 3. Disconnect the AIR INLET tubing at the manifold position. 4. Connect the Service Syringe to the free end of the AIR INLET tubing. 5. Try to aspirate air into the syringe. 6. If no air enters the syringe or resistance is felt, the AIR INLET tubing is clogged or pinched. Replace AIR INLET

tubing with 3.5”. 7. If air flows, refer to Troubleshooting Procedure B.

REMOVE AIR INLET TUBING FROM AIR VALVE AND FITTING.

ATTACH SYRINGE TO FREE END OF AIR INLET TUBING.

(STEPS 2-5)

MEASURING CHAMBER INLET TUBING MUST BE

SAMPLE TRANSPORT TUBING MUST BE 8.5”


PN 701276 Rev 2/03 285

11.7.2 Cleaning ISE Sample Port

Purpose: This procedure is part of weekly maintenance but may also be used to remove clogs in the ISE Sample Port identified by primary and secondary codes.

Materials Needed: Bleach 0.5 mL Pipette Distilled or deionized water 12 mL syringe Silicon rubber tubing

1. From the Main Menu select Diagnostics

2. Select Troubleshoot then select ISE

3. Select Operate Valves and Pump

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. See Fig.1)

Figure 1.

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 12 ml service syringe.

6. Highlight SAMPLE at the system monitor. Press the INSERT key to open the valve.

7. Pipette 0.5 mL of a full strength household bleach solution into the ISE sample port. Allow to soak for three to five minutes.

8. Highlight SAMPLE at the system monitor. Press the INSERT key to open the valve.

9. Draw all of the bleach back into the syringe to the 1mL mark on the syringe.

10. With the tubing still connected, pipette 0.5 mL 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.5mL distilled or deionized water into the ISE sample port and drawback to the 3 mL mark, add another .5

Fitting on Manifold


286 PN 701276 Rev 2/03

mL of distilled or deionized water into the ISE Sample port and draw back to the 4 mL mark on the service syringe.

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.



PN 701276 Rev 2/03 287

11.7.3 Washplate Assembly Cleaning Procedure

Alcohol Pad/Swab

Deionized (DI) Water

Pipette

Kimwipes or Gauze Pad Procedure:

1. With system at the Main Menu, go to Diagnostics, Troubleshoot, Analyzer. The Probe/Transfer Arm will move to the far left to allow better access to the Touchplate (see Figure # 1).

Figure # 1 - Touchplate

2. Using an Alcohol Pad/Swab wipe the touchplate briskly.

3. Using a pipette, place a few drops of D I Water on the Touchplate and rub briskly with Gauze Pad or

Kimwipe.

4. Using Flat Blade Screwdriver scrape the top of the Touchplate (see Figure # 2).

Touchplate


288 PN 701276 Rev 2/03

Figure # 2 – Scrape Top of Touchplate


PN 701276 Rev 2/03 289

5. Using a Sharp Blade scrape the entire inside opening, in particular, the rounded sections of the Touchplate (see Figure # 3).

Figure # 3 – Scrape the Entire Inside Opening Especially the Rounded Sections of the Touchplate

Rounded Sections


290 PN 701276 Rev 2/03

6. Using an unfolded paperclip, scrape the bottom side of the Touchplate paying particular attention to

the rounded sections (see Figure # 4).

Figure # 4 – Scrape Bottom Side of the Touchplate

7. Escape back to the Main Menu and the system will initialize.

Time Required: 10 minutes maximum

11.7.4 Testing and Removing Probe Clogs Purpose: To determine the existence of a probe clog and how to remove the clog, if necessary. Materials Needed:

ACE/NExCT Probe Cleaning Stylette ( Clay Adams 6 inch Pipe Cleaning Wire)

ISE Service Syringe Phillips Head Screw Driver Deionized Water (if necessary)

Rounded Sections


PN 701276 Rev 2/03 291

1. At the Main Menu select Diagnostics to display the Diagnostics menu. 2. Select Verify Modules. Move cursor to the “N” next to Syringe. Press F6 to verify fluid flow. Several

straight, downward stream segments of fluid should be visible coming out of the probe. If not, press escape and return to the first diagnostics menu.

3. Select Miscellaneous to display the Miscellaneous Menu. 4. Select Prime Syringe to display the prime syringe menu. 5. Unscrew the Phillips -head screws in the back of the “L” shaped cover and lift the cover up and off the

instrument. 6. Verify that the diluent tubing (middle line) is connected to system diluent bottle:

• Remove the tubing from the syringe module. Use the service syringe to draw fluid by attaching the tubing to the service syringe and pulling back on the plunger.

• If fluid is flowing, re-attach the tubing to the syringe module. If not, check to make sure the system diluent bottle is seated properly and try drawing again. • If drawing air, the tubing may be detached from under deck. Remove the Reagent Tray,

System Diluent, Cal A and Waste bottle from the unit. Make sure the Cal B and Reference caps are tight before lifting the deck. Lift the deck and replace tubing that is disconnected. If tubing slides off easily trim the end of tubing and reconnect.

Note: If the diluent line is not attached when cover is removed, perform the above procedure then re-attach. (See Figure 1.)

( Figure 1.)

7. Remove the top line from the syringe module and attach the tubing to the service syringe. (see Figure 2)


292 PN 701276 Rev 2/03

(Figure 2.) 8. Using the contents already in the syringe, try to flush the probe. Note: If resistance is felt, stop

immediately. 9. If resistance is felt, move probe arm by hand until probe is resting over the STEP (Sample Tube Entry

Port) module. 10.Gently thread the probe cleaning stylette up the probe until the stylette cannot go any further. Move

the stylette up and down and turn the stylette (if possible) several times to clear the entire probe before removing. (See Figure 3)

S t y l e t t e i n s e r t e d i n t op r o b e

(Figure 3.) 11. Move probe arm by hand until probe is re-centered over washbath (in center

of elliptical hole made by silver plate).

PN 701276 Rev 2/03 293

12. Use syringe to test probe again using deionized water (steps 7 & 8)

Note: A steady straight stream should be visible from the tip of the probe. If the probe is still clogged remove it from the unit and clean manually.

13. Re-fill syringe with deionized water and repeat steps (7 & 8) . 14. Remove service syringe and re-attach tubing to syringe block. 15. Select Fluidics and press Enter. 16. Verify visually that the syringe module is filling with fluid and that the fluid is flowing through the top line. 17. A tear shaped droplet should form on the tip of the probe once the priming is complete. Verify that the

droplet does not fall off and re-form. The droplet should be visible and not change in size too much for three minutes.

18. Escape back to Main Menu.

11.7.5 ACE® and NExCT™ Probe Alignment Procedure 1. Inspection and Adjustment at the ISE PORT

a. From the Utilities Menu, select Probe (for ACE). Select Position transfer arm to ISE port (for ACE). b. From the Diagnostics Menu, select Hardware calibration, select align Probe (for NExCT). Select Move to

alignment Position (for NexCT).

c. Check and align the Probe close to the center of the ISE Port Crosshairs (refer to figure 1).

FIGURE 1

2. Inspection and Adjustment at the WASH BATH

a. From the Utility Menu, select Probe (for ACE). From the Diagnostics menu, select align Probe (for NExCTb. Select Test alignment at wash bath (for ACE and NExCT). c. Watch the Probe movement at the Wash Bath. If the Probe is properly aligned, the Probe should travel across

the middle of the Wash Bath. d. The Probe should strike the left corner of theWash Bath but not the right corner (refer to Figure 2).

ISE PORT

ALIGN PROBE AT ISE PORT CROSSHAIR

IF NECESSARY, MAKE BEND AT THE TOP OF THE PROBE.


294 PN 701276 Rev 2/03

It will also touch the top of the Wash Bath metal plate. e. The Probe should not strike the upper or lower left or right corner of the Wash Bath.

FIGURE 2 NO NO

R

YES N Nnn NO

NO Wash Bath NO

11.7.6 Cuvette Waste Box Sensor Cleaning Procedure Purpose: To clean the cuvette waste box glass-eyed sensors, following an incorrect attention message stating that the cuvette waste box is full. Materials Needed: Distilled or Deionized (DI) water Cotton tipped applicator or Kimwipe Small mirror (optional)

1. Locate the cuvette waste box on the left -hand side of the analyzer.

2. Open the door and remove the cuvette waste box (see Figure 1).

Figure 1. Cuvette Waste Box

3. There are four (4) glass-eye sensors located in the cuvette waste box area to detect the level of cuvettes in the waste box. Two sensors face the front of the system and two (2) face the back of the system (See Figures 2 & 3 ).

PN 701276 Rev 2/03 295

Figure 2. Front Facing Glass-Eye Sensors

Figure 3. Back Facing Glass-eye Sensors

4. To clean these sensors dampen a cotton tipped applicator with DI water and clean the glass-eye sensors. Reagent or sample spillage may splash onto the sensors therefore this step may need to be repeated several times to clean the sensors well. Never use anything except DI water to clean the sensors.

5. Dry all four sensors with a dry cotton tip applicator or Kimwipe.

6. Locate the cuvette waste channel sensor (glass-eye) found above the waste box.

(See figure 4 )

Glass-eye Sensors

Glass-Eye Sensors


296 PN 701276 Rev 2/03

Figure 4. Cuvette Waste Channel Sensor

7. Clean the sensor with a cotton tipped applicator dampened with DI water. A small mirror may be helpful in viewing the glass-eye for cleaning.

8. Clean the small hole facing the left side of the system using a cotton-tipped applicator

dampened with DI water making sure the small hole is open and clean.

9. With the cuvette box removed from the system the FULL BOX and FULL-CHAN should both be highlighted in Diagnostic, Troubleshoot, Sensors, Cuvette Discard on the system monitor.

10. Making sure the red biohazard bag is securely down attached with a rubber band to the

cuvette waste box, replace the cuvette waste box onto the system.

11. The Full Box and Full-Chan should de-highlight, if not the Waste Container Empty sensor may need to be re-calibrated.

12. To calibrate the Waste Container Full Sensor go to Diagnostics, Hardware Calibration,

Cuvette Discard Container Full, hit enter to place a check mark and touch F10. Follow the prompts and continue to touch F10 to proceed.

Glass-eye sensor Channel

Sensor Small Hole

Note: be sure the left side of the Hopper base is below the hold-down tabs before tightening screws.

PN 701276 Rev 2/03 297

11.7.7 Removal and Replacement of the Hopper Module Follower, Inserter or Reaction Wheel error occurs. It should only be used when visual inspection of the Hopper Shuttle fails to reveal the cause of the problem. Read all steps before proceeding.

1. TURN OFF POWER TO ACE AT THE UPS!! 2. Remove the 3 Phillips screws on the back of the ACE top white “L-shape” cover. 3. Unfasten the 3 white plastic pinch connectors across the top left edge of the Hopper Circuit

Board. 4. Remove the “braided cable” (green ground wire on older systems) from the metal connector

located at the front of the Hopper Assembly. 5. Disconnect the blue plastic pin connector (closest to you) and the long red connector (the only one) located about halfway across the bottom side of the circuit board. Note: all connectors have wires facing to the left!! 6. Loosen (don’t remove) the 2 Phillip screws securing the left side the Hopper and the 2 Phillip screws securing

the right side of the Hopper Base . 7. Gently lift the Hopper up and out, taking care to not to snag the connector wires. Remove the shuttle covers

and check for cuvettes that may have been dislodged, jammed or broken either in the Shuttle or in the Analytical Wheel.

8. After correcting the problem, the Hopper may now be replaced. Reverse the above steps from 7 to 2. Note: be sure the Inserter is reset to be about 80 % showing in the bottom cuvette load chamber.

Note: be sure the left side of the Hopper base is below the hold-down tabs before tightening screws. 9. Before replacing the top white “L-shaped” cover, please verify the following:

a. The blue and red connectors are reseated properly (refer to note in step 5) b. All other connectors are firmly seated.

10. Place the cover back on the ACE but don’t attach the cover screws yet.

11. From the MAIN MENU, select Diagnostics, Hardware, Calibration, Analyzer, Table Offset.

12. When the screen returns to the Analyzer menu, the calibration has been completed.

13. Assuming no problems were encountered, the cover screws can be tightened.


298 PN 701276 Rev 2/03

ACE Hopper Module Assembly

Cuvette Follower Provides Hopper

Inventory. Solenoid Plunder

Strips Off Cuvettes

Note: be sure the left side of the Hopper base is below the hold-down tabs before tightening screws.

PN 701276 Rev 2/03 299

ACE Hopper Module Assembly

Cuvette Slots

Cuvette Sleeve or Cartridge Loading Port

Tops of Loaded Cuvettes

Cuvette Follower

Ground Cable or Wire Connection

One of Three Pinch Connectors

Circuit Board


300 PN 701276 Rev 2/03

ACE Syringe Pump Module Assembly

Tubing Out to Probe Assembly

Tubing from System Diluent to Syringe

Pump Tubing out to Waste

Pump Valve Stepper Motor

Index

PN 701276 Rev 2/03 301

Index

abort run, 145 accession

mode, 211 number, 105

alarm volume, 179 analysis module, 4 analysis sequence, 36 analyzer state, 30 archiving mode, 210 backup system, 165 calibration, 36 calibration requisitions, 116 calibrators, 15 carryover parameters, 206 controls, 15, 136 correlation, 45, 141 cup segment

description, 14 loading, 88 remove, 146

curve correction, 38 cuvette cartridge, 12 cuvette hopper

description, 8 loading, 84

cuvette waste box, 97 cuvettes, 12 data management, 147 date format, 210 delete

patient, 172 patient requisition, 171 test, 110

dilution auto, 45 ratios, 185

dimensions, 52 doctor list, 205 electrical service, 53 electrodes

description, 11 installing, 70

equations, 40 error messages, 144 flags, 43 fluid transport system, 4 function keys, 17 hopper, 8 indicator panel, 7 instrument access, 29 ISE

cleaning and conditioning, 74 enabling, 175 installing tubing, 57 maintainance, 223 setting calibration mode, 176 setup, 57 troubleshooting, 270

ISE module, 11 label symbology, 181 LIMS, 177 loadlist

description, 24 maintenance

daily start up, 75, 219 monthly, 230 weekly, 224

menus access, 29 journals, 24 main, 21 navigating, 20 purge, 25 reports, 23 requisitions, 22 selecting a command, 20 setup, 27 status, 28 utilities, 25

modules analysis, 4 ISE, 11 sample/reagent, 5 syringe, 6

monitor, 19 motors, 10 operational precautions, 47 optical system, 8 panels, 203 password, 207 patient requisition

creating, 99 deleting, 171 merged, 152 modifying, 110, 111 ordering tests, 105 printing archived, 170 reviewing, 154

precision data, 137 priority, 35 purging files, 167 purging test counts, 173


302 PN 701276 Rev 2/03

QC requisitions, 113 Quality Control

checks, 189 corrective actions, 137 cumulative statistics, 158 Levey-Jennings plots, 156 overview, 136 parameters, 195, 197 reminder, 207

reaction wheel, 8 reagents

description, 15 ISE, 16, 72 loading, 91 preparing, 90

references ranges, 188 reporting options, 212 reports

backlog, 149, 159 calibration, 161 calibration data, 149 journal, 149, 164 Levey-Jennings, 156 merged, 152 patient, 147, 150 performance, 149, 163 QC, 148, 155 QC statistics, 158 raw data, 149, 161 test counts, 149, 160 test parameters, 149, 162 transmitting to LIMS, 214

requisitions calibration, 116 correction, 118 multiple, 104 patient, 99 QC, 113

restoring system data, 166, 169 results

calculation, 39 calibration, 132 editing, 134 off-line, 134 patient, 130 QC, 131 verifying, 133

RTI mode, 129 sample cups

description, 14 placement options, 124 removing, 146

sample tube entry port, 6 seglet, 13 shutdown, 146 software

installation, 54 version, 30, 216

solutions replacing, 93

specifications, 31 status checks

calibration, 78 cuvette hopper, 82 database, 83 reagent tray, 76 sample ring, 80 tests on-hold, 79

STEP, 6 syringe module, 6 system backup, 165 system overview, 1 system sensors, 9 system setup, 49 temperature

control system, 7 reagent temperature control, 178

tests calculation, 193 creating, 190 customizing parameters, 183 derived, 192 manual rerun, 126 off-line, 191 ordering, 99 panels, 203 remote, 109, 193 running, 121 stopping, 145

Troubleshooting Procedures, 249

UPS, 11 user access, 30 well segments

description, 13 loading, 86 removing, 146

workstation, 17

Index

P/N 701276 Rev 6/04 301

Index

abort run, 144 accession

mode, 209 number, 105

alarm volume, 179 analysis module, 4 analysis sequence, 37 analyzer state, 30 archiving mode, 208 backup system, 164 calibration, 37 calibration requisitions, 116 calibrators, 15 carryover parameters, 204 controls, 15, 135 correlation, 46, 140 cup segment

description, 14 loading, 89 remove, 145

curve correction, 39 cuvette cartridge, 12 cuvette hopper

description, 8 loading, 85

cuvette waste box, 98 cuvettes, 12 data management, 146 date format, 208 delete

patient, 171 patient requisition, 170 test, 110

dilution auto, 46 ratios, 183

dimensions, 53 doctor list, 203 electrical service, 54 electrodes

description, 11 installing, 71

equations, 41 error messages, 143 flags, 44 fluid transport system, 4 function keys, 17 hopper, 8

indicator panel, 7 instrument access, 29 ISE

cleaning and conditioning, 75 enabling, 174 installing tubing, 58 maintainance, 221 setting calibration mode, 175 setup, 58

ISE module, 11 label symbology, a LIMS, 176, 177, c line conditioner, 3 loadlist

description, 24 maintenance

daily start up, 76, 217 monthly, 229 weekly, 222

menus access, 29 journals, 24 main, 21 navigating, 20 purge, 25 reports, 23 requisitions, 22 selecting a command, 20 setup, 27 status, 28 utilities, 25

modules analysis, 4 ISE, 11 sample/reagent, 5 syringe, 6

monitor, 19 motors, 10 operational precautions, 48 optical system, 8 panels, 201 password, 205 patient requisition

creating, 99 deleting, 170 merged, 151 modifying, 110, 111 ordering tests, 105


302 P/N 701276 Rev 6/04

printing archived, 169 reviewing, 153

precision data, 136 priority, 36 purging files, 166 purging test counts, 172 QC requisitions, 113 Quality Control

checks, 187 corrective actions, 136 cumulative statistics, 157 Levey-Jennings plots, 155 parameters, 193, 195 reminder, 205

reaction wheel, 8 reagents

description, 15 ISE, 16, 73 loading, 92 preparing, 91

references ranges, 186 reporting options, 210 reports

backlog, 148, 158 calibration, 160 calibration data, 148 journal, 148, 163 Levey-Jennings, 155 merged, 151 patient, 146, 149 performance, 148, 162 QC, 147, 154 QC statistics, 157 raw data, 148, 160 test counts, 148, 159 test parameters, 148, 161 transmitting to LIMS, 212

requisitions calibration, 116 correction, 118 multiple, 103 patient, 99 QC, 113

restoring system data, 165, 168 results

calculation, 40 calibration, 131 editing, 134 off-line, 133 patient, 129 QC, 130

verifying, 132 RTI mode, 128 sample cups

description, 14 placement options, 123 removing, 145

sample tube entry port, 6 seglet, 13 shutdown, 145 software

installation, 55 version, 30, 214

solutions replacing, 94

specifications, 31 status checks

calibration, 79 cuvette hopper, 83 database, 84 reagent tray, 77 sample ring, 81 tests on-hold, 80

STEP, 6 syringe module, 6 system backup, 164 system overview, 1 system sensors, 9 system setup, 50 temperature

control system, 7 reagent temperature control, 178, c

tests calculation, 191 creating, 188 customizing parameters, 181 derived, 190 manual rerun, 125 off-line, 189 ordering, 99 panels, 201 remote, 109, 191 running, 120 stopping, 144

Troubleshooting Procedures, 249 UPS, 11 user access, 30 well segments

description, 13 loading, 87 removing, 145

workstation, 17

Documents

ACE Operator Manual Rev 6-04