14-fse-017-0 rev 2.0 g8 pm procedure

8/13/2019 14-FSE-017-0 Rev 2.0 G8 PM Procedure

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TOSOH BIOSCIENCE, INC.

G8 PM Maintenance 14-FSE-017Revision 1.0

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Confidential For Internal Use Only

Revision Release Date Origin Reason for Change(s) Change Order

1.0 12/01/2008 Jim Van Etten Initial Release N/A

2.0 02/20/2012 Reggie Vallotton Add requirement that repairs must not be part ofPM process.

TCO-12-016

Reviewed/Approved by:

Jim Van Etten

National Service Manager

Reggie VallottonDirector of Operations


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1.0 PURPOSETo establish a procedure for performing Periodic Maintenance service on the HLC-723G8 (G8)GLYCOHEMOGLOBIN ANALYZER in accordance with Tosoh Bioscience, Inc. standards and

guidelines.

2.0 SCOPEThis 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 ofanalyzers.

3.0 ASSOCIATED DOCUMENTS14- FSE-017-1 G8 PM Check List

4.0 DEFINITIONSSALESLOGIX Database containing customer activity data.

5.0 ResponsibilitiesIt is the responsibility of the National Service Manager to implement this procedure.

6.0 PROCEDURENOTE: 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 Part number = G8PM, Description: G8 PM Kit

6.2 Use FORM 14-FSE-017-1 to document the PM maintenance and testing.6.3 Verify and discuss service and repair history with customer.6.4 Review recent chromatograms for any problems.6.5 Review the condition of the analyzer.6.6 Verify system pressure below 9 Mpa


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6.7 Review error log, section 4.106.8 Print out Parameter list for reference.6.9 Review all Technical Bulletins and inspect analyzer to determine if any upgrades or

Technical bulletins need to be applied before PM is attempted.

6.10 Sample Loader6.10.1 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/wear6.10.4 Clean dust/debris/corrosion/spillage. Lubricate x1, x2 bearing with Triflow.6.10.5 Reassemble/reattach to main analyzer6.10.6 Verify X,Y alignments @ stat and sample positions6.10.7 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.

6.11 Syringe Assembly6.11.1 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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6.11.6 Re-assemble and remove any air bubble from small syringe.

6.12 Injection/Rotary Valves/Drain Valve6.12.1 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 screws6.12.7 Replace the Sample Loop (021601).

6.13 Sampler Mechanism6.13.1 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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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 System6.15.1 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 Supply6.16.1 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/o-

ring), 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 Oven6.17.1 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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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 Verification6.19.1 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 pressure6.19.4 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 RECORDSRecords will be maintained for the life of the product plus 5 years.

14-fse-017-0 rev 2.0 g8 pm procedure

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