TOSOH BIOSCIENCE, INC.

G8 PM Maintenance 14-FSE-017
Revision 1.0 Page: 1 of 6 CONTROLLED DOCUMENT NOTE: Before using this document, verify that your are using the latest revision
Revision 1.0 2.0 Release Date 12/01/2008 02/20/2012 Origin Jim Van Etten Reggie Vallotton Reason for Change(s) Initial Release Add requirement that repairs must not be part of PM process.
Change Order N/A TCO-12-016

Reviewed/Approved by:

Jim Van Etten National Service Manager Reggie Vallotton Director of Operations

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G8 PM Maintenance 14-FSE-017
Revision 1.0 Page: 2 of 6 CONTROLLED DOCUMENT NOTE: Before using this document, verify that your are using the latest revision 1.0 PURPOSE To establish a procedure for performing Periodic Maintenance service on the HLC-723G8 (G8) GLYCOHEMOGLOBIN ANALYZER in accordance with Tosoh Bioscience, Inc. standards and guidelines. SCOPE This procedure is applicable for all devices manufactured or marketed by Tosoh Bioscience, Inc. This procedure applies to all employees or contracted agents involved in the refurbishment of analyzers. ASSOCIATED DOCUMENTS 14- FSE-017-1 G8 PM Check List DEFINITIONS SALESLOGIX Database containing customer activity data. Responsibilities It is the responsibility of the National Service Manager to implement this procedure. PROCEDURE NOTE: ANY part that requires replacement other than those parts identified in the G8PM kit MUST be documented on a separate TICKET with a Service Report activity type of INTERVENTION. The repair ticket must describe the reason the part(s) were replaced and that the parts replaced were failed parts and not replaced as precautionary. 6.1 Parts Required: 6.1.1 6.2 6.3 6.4 6.5 6.6 Part number = G8PM, Description: G8 PM Kit

2.0

3.0

4.0

5.0

6.0

Use FORM 14-FSE-017-1 to document the PM maintenance and testing. Verify and discuss service and repair history with customer. Review recent chromatograms for any problems. Review the condition of the analyzer. Verify system pressure below 9 Mpa

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G8 PM Maintenance 14-FSE-017
Revision 1.0 Page: 3 of 6 CONTROLLED DOCUMENT NOTE: Before using this document, verify that your are using the latest revision 6.7 6.8 6.9 Review error log, section 4.10 Print out Parameter list for reference. Review all Technical Bulletins and inspect analyzer to determine if any upgrades or Technical bulletins need to be applied before PM is attempted. Sample Loader 6.10.1 Remove sample loader reverse of procedure on page 2-13 (Service Manual) 6.10.2 Remove covers. 6.10.3 Inspect x1,x2,y2,y3 belts for tension/wear 6.10.4 Clean dust/debris/corrosion/spillage. Lubricate x1, x2 bearing with Triflow. 6.10.5 Reassemble/reattach to main analyzer 6.10.6 Verify X,Y alignments @ stat and sample positions 6.10.7 Verify bar-code alignment using specimen tube with bar-code label. 6.10.8 Clean drive belts w/DH2O. If it is a 290 loader, clean the Nitflow tape that runs along the inside of the X1 loading area.

6.10

6.11

Syringe Assembly 6.11.1 Remove top cover of main unit and both syringes from mounting bracket per section 6.9.2. 6.11.2 Replace both syringe tips (019515, 018718) see sec. 6.8.1&2 (Service Manual). 6.11.3 Rinse syringe glass barrels to remove any debris from syringes with DI water. 6.11.4 Clean threaded shafts/guide rails/bearing with Triflow. 6.11.5 Inspect coupling set screws.

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G8 PM Maintenance 14-FSE-017
Revision 1.0 Page: 4 of 6 CONTROLLED DOCUMENT NOTE: Before using this document, verify that your are using the latest revision 6.11.6 Re-assemble and remove any air bubble from small syringe.

6.12

Injection/Rotary Valves/Drain Valve 6.12.1 Remove 2 screws to open access door to valves. 6.12.2 Replace injection valve rotor seal (005952) per sec. 6.6.1 (Service Manual).

6.12.3 Replace the stator face (016915). 6.12.4 Tighten the two actuator arm set screws and check backlash. 6.12.5 Replace rotary valve rotor seal (019495) per sec.6.5.1 (Service Manual). 6.12.6 Tighten the coupling set screws 6.12.7 Replace the Sample Loop (021601).

6.13

Sampler Mechanism 6.13.1 Replace sample needle o-rings (220020) per sec. 6.4.2 (Service Manual) 6.13.2 Clean sample needle venting grooves. Build up on groove prevents proper venting operation. 6.13.3 Clean sampler Z axis drive screw & guide rail with Triflow. 6.13.4 Clean/lubricate Y axis guide rails with Triflow. 6.13.5 Clean dilution block surfaces w/DI water. 6.13.6 Re-install sample needle with needle opening facing toward the front for more consistent sample mixing and total areas.

6.14

Pump Assembly

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G8 PM Maintenance 14-FSE-017
Revision 1.0 Page: 5 of 6 CONTROLLED DOCUMENT NOTE: Before using this document, verify that your are using the latest revision 6.14.1 Inspect pump plunger for damage (18502) replace as needed. 6.14.2 Replace pump plunger seal (18517) per sec.6.8.1(Service Manual) 6.14.3 Replace PTFE seal (019056) per sec 6.8.1 6.15 Degasser System 6.15.1 Inspect Vacuum tubing (021652) replace as needed. 6.15.2 Verify pump operation, should reach Vac. within 20 sec., See pg. 6-53 (Service Manual).

6.16

Buffer Supply 6.16.1 Replace intake ceramic filters (018723) and connector tubing (017125). 6.16.2 Inspect cap, stopper, spacer and o-rings (018806-O ring), 019881(Stopper w/oring), 019875(Spacer, buffer cap), 220163(Cap, Buffer bag) -replace as needed. 6.16.3 Replace pre-filter (021600) sec. 5.7 (Operator Manual) 6.16.4 Reset filter count.

6.17

Detector and Column Oven 6.17.1 Enter MAINTED password and turn on recorder. 6.17.2 Pump buffer #1 for 3 minutes. 6.17.3 Verify baseline noise is 0.1mV per sec. 5.3.3 of the Service Manual. 6.17.4 Record the percentage and millivolt reading from the MAINTE screen. 6.17.5 Verify Column Oven temperature is between 24.9C and 25.1C.

6.18

Other Areas
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G8 PM Maintenance 14-FSE-017
Revision 1.0 Page: 6 of 6 CONTROLLED DOCUMENT NOTE: Before using this document, verify that your are using the latest revision 6.18.1 Verify Smart Media operation by inserting card and reading files. 6.18.2 Verify RS232 communication if connected to LIS.

6.18.3 Verify drain lines are draining correctly-Flush as needed. 6.18.4 Clean dust, debris, corrosion, and spillage from inside of main unit. 6.18.5 Reset test count and record life count on checklist.

6.19

Start-up Verification 6.19.1 Power-up and abort warm-up to STBY (stop key 4 times) 6.19.2 Perform prime buffers and DRAIN FLUSH. 6.19.3 Perform pump flow of buffer 1, verify system pressure 6.19.4 Power off/on, allow normal warm-up. 6.19.5 Analyze several patient samples and verify good chromatography. 6.19.6 Make adjustments to Flow parameter as necessary for proper Retention Time for current lot in use. 6.19.7 Perform analyzer calibration per operator manual. 6.19.8 Analyze Level 1&2 control material. If out of range recalibrate and re-run control material. 6.19.9 Analyze 1 normal patient sample X 10 and Calculate precision. CV should be 1% or less.

7.0

RECORDS Records will be maintained for the life of the product plus 5 years.

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