Sigma Amelung Amax 200 User manual

OPERATION MANUAL

User Software Version 3.1.1A

AMAX 200  is a trademark of Sigma-Amelung GmbH

April 2001 A6846

SIGMA DIAGNOSTICS INSTRUMENT WARRANTY

Sigma-Aldrich Co., Inc. ("Sigma"), warrants that instruments it sells to be free from defects in workmanship and materials during normal use by the original purchaser.

This Warranty shall continue for a period of one year from the date of invoice to the original purchaser, or until title is transferred from the original purchaser, whichever occurs first (the "Warranty Period").

If any defects occur during the Warranty Period, contact the Sigma Service Center immediately, and be prepared to furnish pertinent details concerning the defect, the model number, and the serial number.

Warranty service is provided 8:30 a.m. through 5:00 p.m., Monday through Friday, except on Sigma observed holidays. Any service performed at other times, and all service required to correct defects or malfunctions not covered by this Warranty, will be billed on a time-and-material basis at Sigma's labor rates then in effect.

This Warranty does not cover defects or malfunctions which: (1) are not reported to Sigma during the Warranty Period and within one week of occurrence; (2) result from chemical decomposition or corrosion; (3) are described in the applicable Sigma Operation Guide; (4) result from maintenance, repair, or modification performed without Sigma's prior written authorization; or (5) result from misuse, abuse or accident.

Sigma's liability for all matters arising from the supply, installation, use, repair, and maintenance of the instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Sigma's sole discretion) replacement of the instrument or of components thereof. In no event shall Sigma be liable for injuries sustained by third parties, incidental or consequential damages, or lost profits.

Replaced parts shall become the property of Sigma.

THE FOREGOING IS THE SOLE WARRANTY MADE BY SIGMA REGARDING THE INSTRUMENT, AND SIGMA SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE.

 2001 Sigma-Aldrich Co.

April 2001

Table of Contents

1 INTRODUCTION .................................................................................................... 1-1

2 ORGANIZATION OF OPERATION MANUAL ............................................................. 2-1

2.1 PICTOGRAMS ..................................................................................................... 2-1

2.2 SECTION DESCRIPTION ..................................................................................... 2-2

3 SPECIFICATIONS.................................................................................................. 3-1

4 FEATURES............................................................................................................ 4-1

4.1 TEST PROGRAMMING ........................................................................................ 4-1

4.2 PROCESSING...................................................................................................... 4-1

4.3 DATA ARCHIVING............................................................................................... 4-1

4.4 MEASUREMENT MODES.................................................................................... 4-1

4.5 CALIBRATION ..................................................................................................... 4-2

4.6 SAMPLE HANDLING ........................................................................................... 4-2

4.7 REAGENT HANDLING......................................................................................... 4-2

4.8 PIPETTING SYSTEM............................................................................................ 4-3

4.9 TEMPERATURE CONTROL ................................................................................. 4-3

4.10 CUVETTE HANDLING ......................................................................................... 4-3

4.11 THROUGH-PUT................................................................................................... 4-3

4.12 QUALITY CONTROL ............................................................................................ 4-4

5 PHYSICAL DESCRIPTION ...................................................................................... 5-1

5.1 OVERVIEW ......................................................................................................... 5-1

5.2 CUVETTE STORAGE CHUTE .............................................................................. 5-1

5.3 INCUBATION RAIL AND PROBE WASH WELL ..................................................... 5-2

5.4 ROBOT ARM ....................................................................................................... 5-2

5.5 MEASURING WELLS........................................................................................... 5-3

5.6 REAGENT AND SAMPLE TRAY............................................................................ 5-3

5.7 SYRINGE ............................................................................................................ 5-4

5.8 BACK VIEW ........................................................................................................ 5-4

6 GENERAL SOFTWARE USE.................................................................................... 6-1

7 POWER ON ........................................................................................................... 7-1

7.1 AMAX 200 .......................................................................................................... 7-1

7.2 PERIPHERAL EQUIPMENT.................................................................................. 7-1

8 TRAFFIC SIGNAL LIGHTS AND STATUS INDICATOR BAR ...................................... 8-1

8.1 TRAFFIC LIGHTS ................................................................................................ 8-1

8.2 STATUS INDICATOR BAR ...................................................................................8-1

8.2.1 Operating Status .................................................................................... 8-1

8.2.2 Reagent Level Monitor ............................................................................ 8-1

8.2.3 Temperature Monitors ............................................................................ 8-2

8.2.4 Lamp Monitor......................................................................................... 8-2

8.2.5 Cuvette Box Monitor............................................................................... 8-2

8.2.6 Cuvette Tray Waste Monitor ................................................................... 8-2

April 2001 TOC 1

Table of Contents

8.2.7 Fresh Water Input Monitor ..................................................................... 8-2

8.2.8 Waste Water Output Monitor .................................................................. 8-2

8.2.9 Test Group Selection .............................................................................. 8-2

8.2.10 Number of Files in Archive...................................................................... 8-2

8.2.11 File Format Date..................................................................................... 8-2

8.2.12 QC Status Monitor ................................................................................. 8-3

8.2.13 LIS Status Monitor .................................................................................8-3

9 OPERATION - QUICK-START ................................................................................. 9-1

9.1 ENTRY INTO QUICK-START ................................................................................ 9-1

9.2 INTRODUCTION TO QUICK-START DIALOG WINDOW........................................ 9-3

9.3 TEST GROUP SELECTION ..................................................................................9-3

9.4 ORDERING TESTS.............................................................................................. 9-4

9.5 REAGENT TRAY PREPARATION.......................................................................... 9-6

9.6 PRELIMINARY CHECKS ...................................................................................... 9-8

9.7 START PROCESSING .......................................................................................... 9-9

9.8 STOPPING OR ABORTING PROCESSING .......................................................... 9-10

9.9 VIEWING RESULTS .......................................................................................... 9-11

9.10 ADDING NEW SAMPLES................................................................................... 9-11

9.11 REPLENISHING REAGENTS.............................................................................. 9-13

9.12 REPEATING TESTS........................................................................................... 9-13

9.13 ADDING STAT SAMPLES .................................................................................. 9-14

9.13.1 Stat Sample Deletion ............................................................................ 9-15

9.14 PRINTING RESULTS ......................................................................................... 9-16

9.14.1 Routine samples ................................................................................... 9-17

9.14.2 Stat samples......................................................................................... 9-17

9.15 STARTING A NEW SAMPLE TRAY ..................................................................... 9-18

9.16 CHECKING QC RESULTS ................................................................................. 9-18

9.17 OPERATION AND MONITOR FUNCTIONS ......................................................... 9-18

9.17.1 Reagent Overview ................................................................................. 9-19

9.17.2 AMAX200 - Status................................................................................ 9-19

9.17.3 Prime.................................................................................................... 9-20

9.17.4 Wash .................................................................................................... 9-20

9.17.5 Test Groups.......................................................................................... 9-20

9.17.6 Check Reagent ..................................................................................... 9-20

9.17.7 Stop ..................................................................................................... 9-20

9.17.8 Abort .................................................................................................... 9-20

9.18 EXITING QUICK-START .................................................................................... 9-20

ABBREVIATED QUICK-START OPERATING PROCEDURE............................................ 9-22

10 OPERATION - NORMAL ........................................................................................10-1

10.1 REAGENT PREPARATION ................................................................................. 10-1

10.2 FRESH AND WASTE WATER CHECKS.............................................................. 10-3

10.3 CUVETTE PREPARATION.................................................................................. 10-4

10.4 FORMAT

10.5 SAMPLE IDENTIFICATION, POSITIONING AND TEST REQUISITIONING ........... 10-6

10.5.1 Keyboard Addition of New Patients ....................................................... 10-8

DATA FILES ....................................................................................... 10-6

April 2001 TOC 2

Table of Contents

10.5.2 Keyboard Edit of Old Patients ............................................................. 10-10

10.5.3 Position Samples in Sample Tray........................................................ 10-11

10.6 START PROCESSING ...................................................................................... 10-11

10.6.1 Select Test Group ............................................................................... 10-12

10.6.2 Start................................................................................................... 10-12

10.7 PAUSE, STOP AND ABORT ............................................................................. 10-15

10.7.1 Pause ................................................................................................. 10-15

10.7.2 Stop ................................................................................................... 10-16

10.7.3 Abort .................................................................................................. 10-16

10.8 STAT TESTING................................................................................................ 10-16

10.8.1 Stat Requisitioning ............................................................................. 10-16

10.8.2 Viewing and Printing Stat Results....................................................... 10-17

10.8.3 Emptying Stat Positions and Transferring Sample to Archive.............. 10-17

10.9 OVERVIEW ..................................................................................................... 10-18

10.10 GRAPHIC MODE ............................................................................................. 10-18

10.11 REPEAT TESTING ........................................................................................... 10-18

10.12 PRINTOUT OF RESULTS ................................................................................. 10-19

10.13 EVALUATION OF QC RESULTS....................................................................... 10-20

10.14 PRINTOUT OF PATIENT REPORTS.................................................................. 10-21

10.15 ERRORS DURING PROCESSING: NON-FATAL ................................................ 10-21

10.16 ERRORS DURING PROCESSING: FATAL......................................................... 10-22

10.17 SHUTDOWN.................................................................................................... 10-23

11 MEASUREMENT PRINCIPLES ...............................................................................11-1

11.1 MECHANICAL MEASUREMENT (BALL METHOD) ............................................. 11-1

11.2 OPTICAL MEASUREMENT ................................................................................ 11-3

11.3 KINETIC OPTICAL MEASUREMENT (CHROMOGENIC)...................................... 11-5

12 MENUS OVERVIEW ..............................................................................................12-1

12.1 MAIN MENU...................................................................................................... 12-1

12.2 <ALT>-FUNCTION KEYS ................................................................................... 12-3

12.3 <CTRL-F1>-FUNCTION KEYS............................................................................ 12-5

12.4 DOS PARAMETERS........................................................................................... 12-5

12.5 MENUS OUTLINE ........................................................................................... 12-10

12.6 MENUS FLOWCHARTS ................................................................................... 12-14

13 OVERVIEW MENU ................................................................................................13-1

13.1 AMAX200.......................................................................................................... 13-1

13.2 REAGENT ......................................................................................................... 13-2

13.3 RESULTS .......................................................................................................... 13-3

13.4 SAMPLES.......................................................................................................... 13-4

14 SERVICE MENU ...................................................................................................14-1

14.1 PRIME .............................................................................................................. 14-1

14.2 WASH ............................................................................................................... 14-2

14.3 TRANSFER CUP................................................................................................ 14-2

April 2001 TOC 3

Table of Contents

14.4 CHECK REAGENT ............................................................................................ 14-3

14.5 LAMP OFF/ON.................................................................................................. 14-3

14.6 CALIBRATE PHOTOMETER .............................................................................. 14-4

14.7 MOVE SYRINGE ............................................................................................... 14-4

14.8 CHECK VOLUMES ............................................................................................ 14-4

14.9 LOCK CHANNELS ............................................................................................. 14-4

14.10 MONITOR ......................................................................................................... 14-6

15 MEASURE MENU..................................................................................................15-1

15.1 TEST GROUPS .................................................................................................. 15-1

15.2 TRAYS .............................................................................................................. 15-2

15.2.1 Show .................................................................................................... 15-4

15.2.2 Delete ................................................................................................... 15-4

15.2.3 Load ..................................................................................................... 15-5

15.2.4 Load Auto............................................................................................. 15-6

15.3 ROBOT RIGHT .................................................................................................. 15-6

15.4 START............................................................................................................... 15-6

15.5 GRAPHIC ........................................................................................................ 15-12

15.6 PAUSE, STOP AND ABORT ............................................................................. 15-14

15.6.1 Pause ................................................................................................. 15-14

15.6.2 Stop ................................................................................................... 15-15

15.6.3 Abort .................................................................................................. 15-15

16 STAT MENU.........................................................................................................16-1

16.1 QUICK-START................................................................................................... 16-1

16.2 STAT POSITION 1 - 8 ........................................................................................ 16-1

16.2.1 Stat Requisitioning ............................................................................... 16-2

16.3 MONITORING AND PRINTING STAT RESULTS.................................................. 16-4

16.4 EMPTYING STAT POSITIONS AND TRANSFERRING DATA TO ARCHIVE........... 16-4

16.5 END.................................................................................................................. 16-5

17 PATIENTS MENU..................................................................................................17-1

17.1 NEW ................................................................................................................. 17-1

17.2 EDIT ................................................................................................................. 17-5

17.3 ADD.................................................................................................................. 17-7

17.4 REPEAT .......................................................................................................... 17-10

17.5 IMPORT .......................................................................................................... 17-12

17.6 EXPORT.......................................................................................................... 17-12

17.7 PATIENT LIST ................................................................................................. 17-13

17.8 RESULT LIST .................................................................................................. 17-13

17.9 RESULTS LIST ON-LINE ................................................................................. 17-15

17.10 REPORT.......................................................................................................... 17-15

18 SYSTEM MENU 1 .................................................................................................18-1

18.1 FORMAT DATA

18.2 SECURITY SYSTEMS: PASSWORD, SIGN ON, OR SET USER PIN ..................... 18-2

18.2.1 Password .............................................................................................. 18-3

FILES ....................................................................................... 18-1

April 2001 TOC 4

Table of Contents

18.2.2 Sign ON................................................................................................ 18-4

18.2.3 Set User PIN ......................................................................................... 18-4

18.2.3.1 Add an Operator ................................................................... 18-5

18.2.3.2 Signing On ........................................................................... 18-6

18.2.3.3 Delete an Operator ............................................................... 18-7

18.2.3.4 To Edit PIN Information ........................................................ 18-7

18.2.3.5 Forgotten Password .............................................................. 18-8

18.3 DRIVE............................................................................................................... 18-8

18.4 OPTIONS .......................................................................................................... 18-9

18.5 HOST PARAMETERS....................................................................................... 18-11

18.6 LOCATION CODES ......................................................................................... 18-11

18.7 PANELS .......................................................................................................... 18-12

18.8 REPORT FORMAT ........................................................................................... 18-13

18.8.1 To Design the Report Format .............................................................. 18-13

18.8.2 Error Code Definition ......................................................................... 18-14

18.9 VERSION ........................................................................................................ 18-15

19 SYSTEM MENU 2 - PARAMETERS.........................................................................19-1

19.1 TEST GROUPS .................................................................................................. 19-2

19.1.1 To Define or Modify a Test Group ......................................................... 19-3

19.1.2 To Delete a Defined Test Group ............................................................ 19-5

19.2 TESTS............................................................................................................... 19-5

19.2.1 To Define a New Test ............................................................................19-6

19.2.1.1 Description ........................................................................... 19-7

19.2.1.2 Calibration ........................................................................... 19-7

19.2.1.3 Procedure ........................................................................... 19-10

19.2.1.4 Data reduction.................................................................... 19-11

19.2.1.5 Statistics ............................................................................ 19-12

19.2.2 Undo Test Parameter Definition .......................................................... 19-13

19.2.3 Exiting Test Parameter Definition ....................................................... 19-13

19.2.4 Saving Test Parameter Definition ........................................................ 19-13

19.2.5 Copy Test Parameter Definition from One Test to Another .................. 19-14

19.2.6 To Delete a Test from the Test List ...................................................... 19-14

19.2.7 Predilution Mode ................................................................................ 19-14

19.2.8 Derived Fibrinogen ............................................................................. 19-15

19.3 REAGENT LAYOUT ......................................................................................... 19-16

19.3.1 To Define or Modify a Reagent Layout ................................................. 19-17

19.3.2 To Delete a Previously Defined Layout ................................................ 19-18

19.4 REAGENT ....................................................................................................... 19-18

19.4.1 To Define a New Reagent or Modify a Previously Defined Reagent ....... 19-19

19.4.2 To Delete a Reagent ............................................................................ 19-20

19.5 LEVELS .......................................................................................................... 19-20

19.5.1 Diameter ............................................................................................ 19-21

19.5.2 Bottom Levels ..................................................................................... 19-22

19.5.3 Maximum Level .................................................................................. 19-23

19.5.4 Predilution Levels ............................................................................... 19-23

19.6 PUMP.............................................................................................................. 19-24

19.7 MEASURING MODE........................................................................................ 19-25

19.8 TEMPERATURE .............................................................................................. 19-28

April 2001 TOC 5

Table of Contents

19.9 BACK UP ........................................................................................................ 19-29

19.10 RESTORE ....................................................................................................... 19-29

19.10.1 To Restore a Back Up File................................................................... 19-30

19.10.2 To Activate the Back Up Parameters ................................................... 19-31

20 QUALITY CONTROL MENU ...................................................................................20-1

20.1 QC SETUP ........................................................................................................ 20-4

20.1.1 Westgard Definitions ............................................................................ 20-4

20.1.1.1 Rule...................................................................................... 20-5

20.1.1.2 Enabled ................................................................................ 20-5

20.1.1.3 Alarm ................................................................................... 20-7

20.1.1.4 Option .................................................................................. 20-7

20.1.1.5 Flowchart of Information Transfer......................................... 20-9

20.1.2 Controls ............................................................................................. 20-10

20.1.2.1 Addition of a New Control ................................................... 20-10

20.1.2.2 To Modify a Previously Defined Control ............................... 20-13

20.1.2.3 To Delete a Control ............................................................. 20-15

20.1.2.4 Flowchart of Information Transfer....................................... 20-16

20.2 QC FILES........................................................................................................ 20-17

20.2.1 Create ................................................................................................ 20-17

20.2.1.1 On an Inactive Test............................................................. 20-18

20.2.1.2 On an Active Test ............................................................... 20-19

20.2.1.3 On an Undefined or Partially Defined Test .......................... 20-19

20.2.1.4 Reactivation of Previously Closed Files................................ 20-19

20.2.2 List..................................................................................................... 20-21

20.2.3 Export ................................................................................................ 20-22

20.2.4 Backup............................................................................................... 20-22

20.2.5 Restore ............................................................................................... 20-23

20.2.6 Delete ................................................................................................. 20-24

20.2.7 Flowchart of Information Transfer. ..................................................... 20-25

20.3 QC CHARTS.................................................................................................... 20-26

20.3.1 Thumbnail Charts .............................................................................. 20-27

20.3.2 Zoom Chart ........................................................................................ 20-29

20.3.2.1 Introduction ....................................................................... 20-29

20.3.2.2 Commands ......................................................................... 20-30

20.3.2.3 Mean30/Mean .................................................................... 20-33

20.3.2.4 Comment on a Data Point................................................... 20-33

20.3.2.5 Omit a Data Point. .............................................................. 20-34

20.3.2.6 Append a File...................................................................... 20-35

20.3.2.7 Change the Target Value..................................................... 20-36

20.3.2.8 New File.............................................................................. 20-36

20.3.3 Z-Score Distribution Chart ................................................................. 20-37

20.3.4 Print QC Report .................................................................................. 20-37

20.4 RULE SENSITIVITY SETTINGS........................................................................ 20-39

20.5 VIOLATION EXAMPLES .................................................................................. 20-41

20.6 DISTRIBUTION ............................................................................................... 20-45

20.6.1 Distribution Chart and Report ............................................................ 20-45

20.7 CALIBRATION CURVES .................................................................................. 20-46

20.8 REFERENCES................................................................................................. 20-47

April 2001 TOC 6

Table of Contents

21 END MENU...........................................................................................................21-1

21.1 REMOVE STAT SAMPLES ................................................................................. 21-1

21.2 HOST STATUS .................................................................................................. 21-1

21.3 PRINTER BUFFER ............................................................................................ 21-2

21.4 DOS SCREEN ................................................................................................... 21-2

22 CALIBRATION......................................................................................................21-1

22.1 AUTOMATIC DILUTION..................................................................................... 22-1

22.2 MANUAL DILUTION .......................................................................................... 22-5

22.3 SINGLE-POINT CALIBRATION........................................................................... 22-6

22.4 DERIVED FIBRINOGEN .................................................................................... 22-6

23 MAINTENANCE ....................................................................................................23-1

23.1 SERVICE OUTLINE ........................................................................................... 23-1

23.2 DAILY MAINTENANCE ...................................................................................... 23-3

23.2.1 Clean Probe Exterior............................................................................. 23-3

23.2.2 Fresh Water Check ............................................................................... 23-3

23.2.3 Waste Fluid Disposal............................................................................ 23-4

23.2.4 System Wash........................................................................................ 23-4

23.2.5 Hydraulic System Leak Check .............................................................. 23-5

23.2.6 Used Cuvette Disposal .......................................................................... 23-5

23.2.7 Cuvette Cassette Disposal Area Check .................................................. 23-5

23.2.8 General Housekeeping.......................................................................... 23-6

23.3 WEEKLY MAINTENANCE .................................................................................. 23-7

23.3.1 Hydraulic System Cleaning................................................................... 23-7

23.3.2 Dust Filter Cleaning ............................................................................. 23-8

23.3.3 Incubation Rail and Wash/Rinse Well Cleaning .................................... 23-8

23.3.3 Coolant Level Check ............................................................................. 23-9

23.4 MONTHLY MAINTENANCE.............................................................................. 23-10

23.4.1 Syringe Cleaning ................................................................................ 23-10

23.4.2 Cleaning of Photometric Measuring Wells ........................................... 23-10

23.5 MISCELLANEOUS UNSCHEDULED MAINTENANCE ....................................... 23-11

23.5.1 Photometer Calibration....................................................................... 23-11

23.5.2 Volume Check .................................................................................... 23-13

23.6 REPLACEMENT PROCEDURES ...................................................................... 23-14

23.6.1 Photometer Lamp ............................................................................... 23-14

23.6.2 Syringe/Plunger Assembly.................................................................. 23-15

23.6.3 Syringe Plunger Tip and O-Ring.......................................................... 23-15

23.6.4 Tubing................................................................................................ 23-16

24 QUALITY ASSURANCE..........................................................................................24-1

24.1 PATIENT SAMPLE ............................................................................................. 24-1

24.2 REAGENTS ....................................................................................................... 24-1

24.3 INSTRUMENT MECHANICS ..............................................................................24-1

24.4 TEST PARAMETERS ......................................................................................... 24-2

24.5 MEASUREMENT ANALYSIS ..............................................................................24-2

24.6 RESULTS .......................................................................................................... 24-2

April 2001 TOC 7

Table of Contents

25 TROUBLESHOOTING............................................................................................25-1

25.1 NON-FATAL ERRORS........................................................................................ 25-1

25.2 FATAL ERRORS ................................................................................................ 25-1

25.3 GENERAL TROUBLESHOOTING ....................................................................... 25-3

26 INSTALLATION ....................................................................................................26-1

26.1 INSTALLATION.................................................................................................. 26-1

26.2 LOCATION REQUIREMENTS............................................................................. 26-1

26.3 ELECTRICAL REQUIREMENTS AND PRECAUTIONS......................................... 26-1

26.4 REMOVAL OF SHIPPING SAFETY CLAMPS ....................................................... 26-2

26.5 FRESH WATER AND DRAIN CONNECTIONS..................................................... 26-2

26.6 POWER ON ....................................................................................................... 26-2

27 INTERFACE SPECIFICATIONS ..............................................................................27-1

27.1 MODES............................................................................................................. 27-1

27.2 BI-DIRECTIONAL INTERFACE DESCRIPTION ................................................... 27-1

27.3 PROTOCOL ....................................................................................................... 27-3

27.3.1 MASTER to SLAVE ............................................................................... 27-3

27.3.2 SLAVE to MASTER ............................................................................... 27-4

27.4 COMMAND CHARACTERS AND SYMBOLS ....................................................... 27-5

27.5 TIMEOUT.......................................................................................................... 27-5

27.6 REPEAT AFTER <NACK>................................................................................... 27-5

27.7 EXAMPLES (AMAX AS MASTER) ....................................................................... 27-6

27.8 EXAMPLE OF HEADER AND TEST ORDER..................................................... 27-10

April 2001 TOC 8

Introduction

1 INTRODUCTION

1 INTRODUCTION .................................................................................................... 1-1

April 2001 1-0

Introduction

The AMAX 200 is an automated random access multi-purpose analyzer. The AMAX 200 may be used as a coagulation analyzer for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles.

Such tests include prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen concentration, thrombin time (TT), functional factor assays and other clotting tests ending with fibrin formation. In addition, the AMAX 200 may be used for chromogenic kinetic enzyme analysis (405nm). Such tests include antithrombin (AT), protein C, protein S, antiplasmin, heparin, plasminogen, PAI-1, tPA and other assays utilizing an indicator molecule detected at 405 nm. Measurement may be qualitative or quantitative. When used in conjunction with appropriate reagents, the sample may be plasma, serum or whole blood.

The AMAX 200 is PC controlled. To provide optimum performance and maximum versatility, the operating parameters for each test are individually programmed.

Patient samples are identified by the commander PC and registered in a patient file. With the use of the on-board barcode reader, patient identification is positive. Patient demographic and result information is archived for subsequent retrieval. Both the results and the correlated calculations are stored in the patient file. Information may be transferred to and from a host computer through a bi-directional interface.

The sample storage area is cooled to approximately 15°C. which minimizes sample deterioration and prevents spontaneous cold activation that may occur at colder temperatures. Sampling may be from primary tubes or secondary transfer tubes. Sample and reagent are added using a temperature-controlled probe. All incubation times are programmable. The programmed volume of reagent is added at the programmed time. With addition of the start reagent, either the elapsed time or absorbency is measured.

The measured results are calculated into concentration or activity units with the use of stored calibration curves.

On-line, real-time statistical analysis and evaluation of QC data assists in determining if results are valid and patient results may be reported.

Waste disposal is automatic with minimal operator contact with potentially biohazardous materials.

April 2001 1-1

Specifications

1 SPECIFICATIONS

3 SPECIFICATIONS.................................................................................................. 3-1

April 2001 3-0

Specifications

AMAX 200 Dimensions

•

Height 25 inches (64 cm)

•

Width 32¾ inches (83 cm)

•

Depth 28¾ inches (73 cm)

Keyboard

•

Height ca. 1¼ inches (3 cm)

•

Width ca. 11 inches (28 cm)

•

Depth ca. 5¼ inches (13 cm)

Printer

•

Height ca. 10 inches (25 cm)

•

Width ca. 13¾ inches (34 cm)

•

Depth ca. 22 inches (55 cm)

Optional Base Unit Dimensions

•

Height 28¼ inches (71 cm)

•

Width 32¾ inches (82 cm)

•

Depth 27¾ inches (69 cm)

Weight

•

AMAX 200 286 pounds (130 kg)

•

Base Unit 165 pounds (75 kg)

Electrical

•

Voltage 90 - 132 VAC; 60 Hz

180 - 265 VAC; 50 Hz

•

Power Consumption 600 VA

•

Fuse Requirements 5A (t) 6.3x32 and 10A (t) 6.3x32

Room Temperature Requirements

•

Maximum Operating Temperature 90°F (32°C)

•

Compensation Required 2047 BT

April 2001 3-1

Features

4 FEATURES............................................................................................................ 4-1

4.1 TEST PROGRAMMING ........................................................................................ 4-1

4.2 PROCESSING...................................................................................................... 4-1

4.3 DATA ARCHIVING............................................................................................... 4-1

4.4 MEASUREMENT MODES.................................................................................... 4-1

4.5 CALIBRATION ..................................................................................................... 4-2

4.6 SAMPLE HANDLING ........................................................................................... 4-2

4.7 REAGENT HANDLING ......................................................................................... 4-2

4.8 PIPETTING SYSTEM............................................................................................ 4-3

4.9 TEMPERATURE CONTROL ................................................................................. 4-3

4.10 CUVETTE HANDLING ......................................................................................... 4-3

4.11 THROUGH-PUT................................................................................................... 4-3

4.12 QUALITY CONTROL ............................................................................................ 4-4

April 2001 4-0

Features

4.1 Test Programming

•

Up to 32 tests may be programmed at one time

•

All sample and reagent volumes, incubation times, reagent addition times and measurement times are programmable to provide maximum flexibility and optimum test performance

4.2 Processing

•

Random access; multi-tasking

•

Process mechanical, optical and chromogenic tests simultaneously

•

Choice of two operating modes: normal and quick-start

•

Normal mode: up to 12 tests processed simultaneously using multiple screens to provide for maximum operating flexibility

•

Quick start: up to 8 tests processed simultaneously with all operations performed using one screen

4.3 Data Archiving

•

Up to 1,020 patients may be archived on commander PC hard drive

•

Optional storage of patient data archive on floppy discs

•

Patient demographic, value results and correlating calculation information is stored in the archive. With graphic mode on, graphic representation of each reaction is also stored in the archive

4.4 Measurement Modes

•

Photo-optical/chromogenic: 4 channels, 405 nm

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Mechanical: 4 channels

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Minimum reaction volume, mechanical: 75 µL

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Minimum reaction volume, optical/chromogenic: 150 µL

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Maximum reaction volume, all modes: 600 µL

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Programmable mechanical impulse mode minimizes break-up of fragile fibrin clots

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Simultaneous mechanical, photo-optical and chromogenic analysis

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Real-time graphic reaction display for optical and chromogenic kinetic analyses

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28 clotting measuring modes; 16 chromogenic measuring modes

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Monitor available to observe the performance of individual measuring wells

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Channel locking to remove selected measuring wells from service facilitates troubleshooting and minimizes downtime by enabling continuation of processing in the event of isolated channel component failure

April 2001 4-1

Features

4.5 Calibration

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1 to 8 calibration curve points

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Automatic dilution at any desired dilution from 1:1 to approximately 1:14,000

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Calculation and display of correlation coefficient for each curve

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Dilution of calibration reference material either automatically or with previously prepared dilutions

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Choice of 10 curve calculation types

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Graphic display of calibration curve for easy visual evaluation

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Ability to recalculate curve data using multiple curve calculation types

4.6 Sample Handling

Cooled (15 ± 3°C) sample storage area with 60 position continuous-addition sample

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tray

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Up to 8 samples at one time may be processed as Stats

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Up to 17 sample trays with up to 60 samples each may be prepared for processing (1,020 samples) in a file format period

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5 µL minimum sample volume

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Choice of duplicate or single sampling for each test within a test group

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Automatic sample predilution at any desired dilution from 1:1 to 1:100

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Automatic dilution to either a higher or lower dilution when result exceeds calibration curve limits

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Automatic repeat at a programmable extended time interval for samples failing to clot within the specified measurement time

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Integrated bar code scanner provides capability for positive patient ID

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Optional off-line bar code scanner provides capability for alternative patient ID entry

4.7 Reagent Handling

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Cooled (15 ± 3°C) reagent storage area with 24 position reagent tray; 16 used only for reagent storage, 8 used for either reagent storage or as Stat sample positions

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3 stir-bar positions

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Up to 50 reagents may be defined

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Operator notification of expired reagents

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Up to 5 reagents may be programmed for each test

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Up to 12 different reagent tray layouts may be programmed

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Minimum reagent levels required prior to and during processing are programmable; reagent levels are continuously monitored and may be refilled with no processing interruption; audible alarm notifies operator of low reagent volume condition

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Reagent container dead volume dependent on container size and on the programmed bottom level sense

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No tubing; direct probe reagent aspiration results in no reagent waste and minimal daily maintenance

4-2 April 2001

Features

4.8 Pipetting System

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Samples and reagents are transferred to the reaction cuvette with a temperaturecontrolled probe (37 ± 0.5°C)

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Liquid level sensor for both sample and reagent

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Bottom level sensing programmable to any depth for both sample and reagent positions

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Cleaning of probe programmable for each reagent

4.9 Temperature Control

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Reagent/Sample trays: 15 ± 3°C

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Incubation rail: 37 ± 0.5°C

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Probe: 37 ± 0.5°C

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Optical measuring wells: 37 ± 0.5°C

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Mechanical measuring wells: 37 ± 0.5°C

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Continuous monitoring and display of temperatures

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Temperature warning and stop limits are programmable. Audible alarm and flashing display when temperature is out of the warning limit range. Program stop if temperature condition is out of the stop limit range and is not corrected within a specified time period

4.10 Cuvette Handling

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450 on-board cuvette capacity with continuous refill without processing interruption

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Automatic disposal of cuvettes through measuring wells at completion of measurement timing

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Maximum cuvette utilization

4.11 Through-Put

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Variable; dependent on test combination, programming and sample conditions

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Typical through-put:

Tests/Hour Single Duplicate

PT-Mechanical (Pipette mode 0) 180 180 90

PT-Mechanical (Pipette mode 2) 240 240 120

PT-Optical (Pipette mode 0) 190 190 95

PT-Optical, Derived Fibrinogen 120 120 60

APTT-Mechanical or Optical 110 110 55

Fibrinogen 115 115 57

AT 80 80 40

Factor Assay 120 120 60

PT-Mechanical/APTT 120 60 30

PT-Mechanical/APTT/AT 90 30 15

Patients/Hour Patients/Hour

April 2001 4-3

Features

4.12 Quality Control

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Unlimited number of control files

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1000 result positions per control level file

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Levey-Jennings-like graphic representation of up to 1000 results on each control for each test programmed

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Zoom chart feature to view specific details including historical rule violations and operator-entered comments; each data point has associated result, date measured, time measured, operator logged on when result processed, Westgard rule evaluation and audit trail for point omission information available

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Any data point may be omitted after user ID and comment are entered

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Optional user ID system with four authorization levels available

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Multiple breakdown (last 30 results, all results, all results up to cursor position) of statistical data

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Laboratory defined operator alert conditions with QC error

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Real-time performance monitor

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Westgard Rules or other laboratory definable result criteria evaluation

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Optional processing stop in event of a QC error

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QC File backup and restore functions available

4-4 April 2001

Physical Description

1 PH

YSICAL DESCRIPTION

2 PH