ENTIRE CONTENTS COPYRIGHTABBOTT LABORATORIES 1988, 1992, 1994PRINTED IN THE U.S.A.

ABBOTT LABORATORIESABBOTT PARK, IL 60064 U.S.A.69-6301/R5

OPERATIONMANUALLIST NO. 8376-07

Revision Log

69-6301/R5 IMx System Operation Manual -iii-

Revision LogThe Revision Status of the manual is indicated below. Be sure that the manual contains the latest revision number of all pages. Additional copies of this manual may be purchased.

Revision Status

Revision Date Pages Revised and Added

Originally Issued 6/88 Not Applicable

41493-102 8/88 All Pages

41493-102/3 9/88 1, 2, 3, 4, 5, 6, 1-16, 1-20, 1-25, 5-51, 6-4, 6-7, 6-16, 6-19, 6-22, 6-24, 9-47, 9-51, 9-55, 10-78, 10-79, 10-80, 10-81, 10-82

Index

41493-104 1/90 All Pages

List No. 8376-03 10/90 All Pages

List No. 8376-05 8/91 All Pages

List No. 8376-06 7/92 All Pages

List No. 8376-06 4/94 Sections 2, 5b, 6b, 8, 9a, 10, 10a, 10b, 10c, Index

List No. 8376-06 9/94 Table of Contents Sections 1,2Index

List No. 8376-06 3/95 Sections 1,4

List No. 8376-07 3/03

69-6301/R5 FrontMatter Cover page

69-6301/R5 Revision Log iii, iv

69-6302/R2 Section 9 9d-19, 9d-20

Revision Log

-iv- IMx System Operation Manual 69-6301/R5

*User should record revision number and sign and date this log to provide a permanent record of revisions.

Revision Number*RevisionSoftware Version Incorporated By Date Incorporated

41493-104 V2.0List No. 8376-03 V3.0List No. 8376-05 V5.0List No. 8376-06 V6.0

Section 9Maintenance As Required Maintenance

69-6302/R2 IMx System Operation Manual 9d-19

Step 9 Verify that the probe is centered over the cross target.

If the probe position is correct, save the position:

Press [STORE]

If the position is incorrect, press [REPEAT]. Return to Step 4 of the SELECT Reagent Pack Calibration procedure.

Step 10 Once the reagent positioning pack positions are stored, the boom assembly parks before beginning the Level Sense Calibration procedure.

Level SenseCalibration

The Level Sense Calibration sets the vertical height reference point necessary for the probe/electrode assembly to sense liquid in the following components:

Reaction cell

FPIA sample cartridge

SELECT reagent packs

The vertical boom reference point is determined with 50 L of diluent buffer in the sample well of the blank cell. The IMx System automatically calculates the other vertical reference points from this value.

Step 1 Place unused blank cells into positions #2, #7, #12, #17, and #22 on the MEIA or SELECT carousel, and lock the carousel.

Step 2 Place the loaded carousel onto the centerpost.

Step 3 Close the access door.

Step 4 Start the Level Sense Calibration procedure.

Press [START]

The MEIA optical assembly verifies the correct placement of the blank cells.

The dispense system primes several times before dispensing 50 L of MEIA #2 diluent buffer into the five sample wells.

Step 5 Once the syringes start priming, open the access door.

The probe / electrode assembly lowers and senses liquid in each sample well. The liquid level value is displayed and printed for each blank cell position.

The five values must be within three steps of each other and within the optimal range of 260-270 steps.

9d-20 IMx System Operation Manual 69-6302/R2

Section 9As Required Maintenance Maintenance

Step 6 Determine whether the Level Sense Calibration is valid.

If the liquid level values are valid, new vertical height reference points are automatically stored in memory, and the following message is displayed:

STORING CALIBRATION

The liquid levels are invalid if the five values are not within three steps of each other, or outside of the optimal range of 260-270 steps.

Based on system software settings the message INVALID LEVELS may not be displayed for levels outside of the 260-270 range.

If the Level Sense Calibration was invalid, proceed to Step 7.

If you have already repeated the Level Sense Calibration and the levels are still invalid, contact the IMx Customer Support Center; proceed to Step 8.

Step 7 Repeat the Level Sense Calibration.

Remove the MEIA or SELECT carousel from your IMx System.

Empty the MEIA or SELECT carousel over the appropriate waste receptacle.

Place unused blank cells into positions #2, #7, #12, #17, and #22 on the MEIA or SELECT carousel.

Lock the MEIA or SELECT carousel and place it onto the centerpost.

Close the access door.

Press [REPEAT].

Return to Step 5 of the Level Sense Calibration.

Step 8 Determine whether to perform FPIA Sample Cartridge procedure.

After Level Sense Calibration is stored, the display window automatically goes to the FPIA Sample Cartridge procedure, which follows.

If only MEIA Assays are performed on your system, you are finished with MEIA and SELECT Boom Calibration. Press [EXIT] to return to the Main Menu.

If FPIA assays are performed on your IMx System, continue to the FPIA Sample Cartridge Calibration procedure.

Note

Revision StatusTable of ContentsIntroduction1. System DescriptionSystem Use / FunctionIMx SubsystemsIMx Components and Consumables

2. InstallationInstalling Your IMx SystemInitializing Your IMx SystemSystem Checks and CalibrationsRelocation Procedure

3. Theory of OperationHow MEIA Technology WorksHow Ion Capture Technology WorksHow FPIA Technology Works

4. System Specifications5. System Operation - Running AssaysGeneral InformationMEIA AssaysSELECT AssaysFPIA Assays

6. System Operation - SoftwareMenus and Function KeysSystem Files and Assay Files

7. CalibrationSystem CalibrationAssay Calibration

8. Precautions, Limitations and HazardsEmergency Shutdown ProcedurePrecautions and LimitationsDecontamination ProceduresPreventing Azide Formation in Laboratory Plumbing

9. MaintenanceDaily MaintenanceWeekly MaintenanceMonthly MaintenanceAs Required Maintenance

10. TroubleshootingGeneral Troubleshooting ProceduresError Codes and System MessagesObserved ProblemsComponent Replacement