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Technical Bulletin Number: 06262002 TECHNICAL BULLETIN Classification 0Retrofit 0Upgrade I (U1) 0Upgrade II (U2) 0Upgrade III (U3) 1Other Information Reference Documentation: N/A Engineering Review: QA Review: Instrument(s) Affected: Benchmark, NxIHC, Special Stains, ES and Renaissance Tissue Processor (TP 1530) Serial Number(s) Affected: All Subject: Test and Inspection data requirements Problem: In the past, it was not required to submit a completed Level One Diagnostic or Preventive Maintenance checklist to Ventana for filing in the complaint history file for the customer. Per newly established guidelines, this has changed. A completed Level One or PM checklist is now required to be submitted with each Field Service Report. Corrective Action: Effective immediately, a completed Level One Diagnostic checklist or a completed Preventive Maintenance checklist must be attached to the Field Service Report submitted to Ventana. Use the Level One checklist for repair type activities and the PM checklist for periodical maintenance. A Level One Diagnostic checklist is not required for installation. The completed checklist should include: Service Representative Customer name and ID Number Service Request Number Serial Number(s) for Instrument or Staining Module and if applicable- AFM or BFM and CPU Test Equipment Information (if applicable) to include ID # and Calibration due date Checkmark in left most column indicating that the step was completed to specification Test Data Service Representative signature Date of service Comments: Document all deficiencies in comments section of Field Service Report. Benchmark Level One Diagnostic Page 1 of 1 Service Rep: Test Equipment Information Customer: Description I.D. # Cal Due I.D. Number: Digital Scale Service Request Number: Pressure Gauge Staining Module Serial Number: Flow Meter AFM Serial Number: Mixer Height Gauge Computer Serial Number: ﹟ Description Clean bottle filter inserts Verify reagent homing alignment and jog reagent tray to verify position to position alignment Verify slide homing alignment and jog slide carousel to verify position to position alignment Verify slide bar code read alignment Verify reagent bar code read alignment Verify dispense cylinder actuation Verify operation of air knife Verify instrument level Test and record vortex mixer flow rates Min-Max: Outer 210-330 ml/min, Inner 425-725 ml/min Station Trial Station Trial Station Trial Station Trial 20 (outer) 20 (inner) 14 (inner) 9 (inner) 19 (outer) 19 (inner) 13 (inner) 8 (inner) Verify mixer performance Test and record system air pressure: Min-Max: 12.8-13.0 psi Test and record ISH slide volumes Min-Max: .090 - .130 grams, Avg: .090 - .130 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Avg: Test and record heater oil volumes Min-Max: .060 - .100 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Test and record IHC slide volumes Min-Max: .240 每 .300 grams, Avg: .255 - .285 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Avg: Test and record rinse volumes Min-Max: 5.65 每 7.50 grams, Avg: 5.85 每 7.50 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Avg: Test and record EZ Prep volumes Min-Max: .530 - .630 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Test and record coverslip volumes Min-Max: .80 每 1.08 grams, Range <.100 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Range: Test and record CC1 volumes Min-Max: .350 - .475 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Test and record CC2 volumes Min-Max: .300 - .400 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Comments: Service Rep Signature: Date: Benchmark Preventive Maintenance Page 1 of 2 Service Rep: Test Equipment Information Customer: Description I.D. # Cal. Due I.D. Number: Digital Scale Service Request Number: Pressure Gauge Staining Module Serial Number: Flow Meter AFM Serial Number: Mixer Height Gauge Computer Serial Number: ﹟ Description Clean bottle filter inserts and inspect associated o-rings Verify operation of bottle and waste level sensors Verify operation of bottle inlet check valves Verify operation of vacuum trap check valve Verify vacuum of -4.5 psi between vacuum relief valve and vacuum trap valve Replace compressor muffler Inspect reagent belt, replace if necessary Replace teflon pads under reagent carousel sprocket Verify reagent homing alignment and jog reagent tray to verify position to position alignment Inspect variable restrictor adhesive mounting pad for mixers Inspect slide belt, replace if necessary Inspect and clean waste block and tub Verify slide homing alignment and jog slide carousel to verify position to position alignment Verify slide bar code read alignment Verify reagent bar code read alignment Verify operation of cooling fan Verify operation of overflow sensor Verify operation of slide heaters Verify dispense cylinder actuation Verify operation of air knife Verify instrument level Test and record vortex mixer flow rates Min-Max: Outer 210-330 ml/min, Inner 425-725 ml/min Station Trial Station Trial Station Trial Station Trial 20 (outer) 20 (inner) 14 (inner) 9 (inner) 19 (outer) 19 (inner) 13 (inner) 8 (inner) Verify mixer performance Test and record system pressure loss: Max: < 3psi/2min Test and record system air pressure: Min-Max: 12.8 - 13.0 psi Test and record PRV pressure: Min-Max: 25 psi Test and record ISH slide volumes Min-Max: .090 - .130 grams, Avg: .090 - .130 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Avg: Test and record heater oil volumes Min-Max: .060 - .100 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Benchmark Preventive Maintenance Page 2 of 2 Test and record IHC slide volumes Min-Max: .240 每 .300 grams, Avg: .255 - .285 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Avg: Test and record rinse volumes Min-Max: 5.65 每 7.50 grams, Avg: 5.85 每 7.50 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Avg: Test and record EZ Prep volumes Min-Max: .530 - .630 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Test and record coverslip volumes Min-Max: .80 每 1.08 grams, Range <.100 Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Range: Test and record CC1 volumes Min-Max: .350 - .475 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Test and record CC2 volumes Min-Max: .300 - .400 grams Trial 1: Trial 2: Trial 3: Trial 4: Trial 5: Verify instrument level Run Temperature Verifier Slides 0 Pass 0 Fail Comments: Service Rep Signature: Date: NexES-IHC Level One Diagnostic Page 1 of 1 Service Rep: Test Equipment Information Customer: Description I.D.
Approximate Word count = 3135
Approximate Pages = 12.5
(250 words per page double spaced)
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