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Manual Reference
iQ200 Sprint Automated Urine Microscopy Analyzer Service Manual, 300-4949 Rev A, 01/2005
Manufacturer Recommendation / AEM Status
Manufacturer-listed PM frequencies
The manual lists two classes of preventive maintenance:
Semi-Annual Preventive Maintenance: Performed 6 months after installation or 6 months after the last Annual Certification. Applies regardless of sample count.
Annual Certification: Performed 6 months from the last Semi-Annual Preventive Maintenance. Applies regardless of sample count.
Practical interval interpretation: the manufacturer-listed schedule alternates service events every 6 months, with an Annual Certification occurring every other PM cycle.
Manufacturer-listed PM kits
iQ200 Sprint Preventive Maintenance Kit: PN 799-3059
iQ200 Sprint Annual Certification Kit: PN 799-3058
Manufacturer-listed PM items
Manufacturer-listed PM items include external surface cleanup, STM module cleanup, fluidic system flush, Rinse/Waste Well cleanup, fluidic component replacement, peristaltic pump cassette replacement, tubing replacement, sampler calibration verification, tube detector verification, barcode scanner alignment verification, SPA alignment verification, fluidic inspection for leaks and bubbles, optical bench verification, Auto-Focus run, Calibration run, Control run, and PM checklist documentation.
Manufacturer-listed replacement parts
Peristaltic pump cassette replacement:
Cannula Pump cassette: PN 700-3823
Evacuation Pump cassette: PN 700-3822
Lamina Pump cassette: PN 700-3822
Tubing / fluidic components:
Tubing fitting assembly, EBV N.O. Port to Flow Cell drain: PN 700-3855
Tubing fitting assembly, EBV Common Port to Evacuation Pump input: PN 700-3857
Tubing fitting assembly, DRV valve to Flow Cell de-bubble port: PN 700-3859
Specimen filter: PN 700-3891. Manufacturer lists this as Annual Certification only.
Tubing fitting assembly, Specimen Filter to PBV N.C. Port: PN 700-3895
Tubing fitting assembly, PBV Common Port to Flow Cell cannula input: PN 700-3807
Tubing Assembly, Waste Well yellow connector to Evacuation Pump: PN 700-3806
Electrical safety testing manufacturer status
The PM section of the provided manual does not list an electrical safety test requirement, ground resistance limit, or leakage current limit as part of the PM procedure.
If the facility performs electrical safety testing during PM, document it under facility policy / NFPA 99 / local HTM procedure. Do not assign a manufacturer leakage limit unless another manufacturer document or facility policy provides one.
AEM note
If a facility performs this PM at a different interval or changes the listed activities, that should be handled under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.
What This PM Procedure Covers
This procedure covers semi-annual PM and Annual Certification workflow, cleaning and fluidic flushing, pump cassette and tubing replacement, annual specimen filter replacement, alignment and calibration verification, Auto-Focus, calibration, control performance checks, electrical safety documentation when required by facility policy, and CMMS-ready PM documentation.
Required Tools and Equipment
Manual-supported or procedure-supported items
Iris System Cleanser diluted 1:10
Iris Diluent
Focus Solution
Calibration material
Positive and Negative Control material
CONTROL rack
Calibration rack
Routine/sample racks
16 x 100 mm glass test tubes
Lint-free paper towels
Protective gloves
Hemostat for clamping Lamina line during Lamina Pump cassette replacement
Service Application Software
Barcode Utility Software
Runfile Analyzer
Applicable PM checklist: F-19-0044 Rev B for Distribution Partners, F-19-0043 iQ200 Preventive Maintenance Checklist, or F-19-0042 iQ200 Annual Certification Checklist
Facility-policy-dependent items
Electrical safety analyzer
Ground resistance test lead
Leakage current test setup
Step-by-Step PM Procedure
1. Confirm PM Type
Action: Confirm whether this visit is a Semi-Annual PM or Annual Certification.
Expected outcome: Correct kit, replacement parts, and checklist are used.
Why it matters: The specimen filter replacement is listed for Annual Certification only.
2. Prepare the Analyzer
Action: Confirm the analyzer is available for service. Follow laboratory downtime procedures before stopping use.
Expected outcome: No patient specimens are interrupted or resulted during service.
3. Perform External Surface Cleanup
Action: Clean all external instrument surfaces using 1:10 diluted Iris System Cleanser and lint-free towels. Give special attention to the STM module. Wear protective gloves.
Expected outcome: External surfaces and sample transport areas are clean and free of residue.
4. Perform Fluidic System Flush
Action: Prepare a CONTROL rack with Iris System Cleanser solution in position 1 and Iris Diluent in positions 2 and 3. Run this rack three times.
Expected outcome: Fluidic system is flushed with cleanser and diluent.
5. Clean Rinse/Waste Well Assembly
Action: Clean the Rinse/Waste Well Assembly surfaces using 1:10 diluted Iris System Cleanser.
Expected outcome: Rinse/waste well surfaces are clean with no visible buildup.
6. Power Down and Access Internal Areas
Action: Turn off the instrument and remove the front and top panels as needed for service access.
Expected outcome: Internal fluidic components are accessible for inspection and replacement.
7. Replace Peristaltic Pump Cassettes
Action: Replace the Cannula Pump cassette PN 700-3823, Evacuation Pump cassette PN 700-3822, and Lamina Pump cassette PN 700-3822.
Clamp the tube between the Lamina Bottle and Lamina Pump with a hemostat before Lamina Pump cassette replacement. Remove the hemostat after the new cassette is secured.
Expected outcome: Pump cassettes are replaced and all pump doors are properly closed.
8. Replace Manufacturer-Listed Tubing Components
Action: Replace listed tubing/fitting assemblies PN 700-3855, PN 700-3857, PN 700-3859, PN 700-3895, PN 700-3807, and PN 700-3806.
Use caution around the Flow Cell connections. The manual specifically cautions against damaging the Flow Cell during tubing removal/replacement.
Expected outcome: Listed tubing components are replaced with no loose fittings or damage.
9. Annual Certification Only - Replace Specimen Filter
Action: During Annual Certification, replace the Specimen Filter, PN 700-3891. Install with the arrow pointing away from the pipettor.
Expected outcome: Specimen filter is replaced and installed in the correct flow direction.
10. Verify Sampler Calibration
Action: Using iQ200 service software, verify the rack position adjustment in front of the tube detector. Record cal [0] “Delta position from Home to Tube”.
Expected outcome: Rack position is correctly aligned in front of the tube detector.
11. Verify Tube Detector
Action: Verify and adjust, if necessary, the tube detector threshold value. Record cal [8] “Tube Detector Threshold Adjust”.
Expected outcome: Tube detector correctly identifies tube present / no tube.
12. Verify Barcode Scanner Alignment
Action: Use Barcode Utility Software to verify scanner alignment. Adjust if necessary.
Expected outcome: Barcode scanner alignment is verified and customer labels read correctly.
13. Verify SPA Alignment
Action: Verify correct pipette position at the waste well, test tube, and test tube depth. Use the Chapter 4 adjustment procedures as needed.
Expected outcome: Pipette alignment is correct and does not contact or miss target positions.
14. Inspect and Prime Fluidic System
Action: Run a CONTROL rack with Iris System Cleanser in position 1 and Iris Diluent in positions 2 and 3. Run the rack three times. Inspect all fluidic lines and fittings for air bubbles, leaks, loose fittings, and improper routing.
Expected outcome: Fluidic system is primed, leak-free, and free of visible air bubbles.
15. Verify Optical Bench
Action: Enter Service Application Software and verify optic positions under View > Video. Use Runfile Analyzer to verify Flow Cell tilt. Verify and adjust, if necessary, optical system collimation, Flow Cell lateral position, and Flow Cell tilt.
Expected outcome: Optical bench checks pass or are adjusted per Chapter 4 procedures.
16. Run Auto-Focus
Action: Place a tube of Focus Solution in the Control rack at position 5. Perform Auto-Focus.
Expected outcome: Auto-Focus completes successfully.
17. Run Calibration
Action: Run Calibration.
Expected outcome: REF value is between 1.4 and 2.7.
18. Run Controls
Action: Run 10 Positive/Negative Controls.
Expected outcome: Positive Control runs are within range with CV < 5% using Runfile Analyzer.
19. Complete PM Checklist Documentation
Action: Record results on the appropriate PM checklist form.
Expected outcome: PM or Annual Certification documentation is complete and retained per facility procedure.
Electrical Safety Testing if applicable
The provided PM section does not list manufacturer-required electrical safety testing for this PM.
Perform electrical safety testing if required by facility policy, after internal service, after liquid exposure, after power-related repair, or under local HTM procedure.
Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different:
Result =
Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =
Pass / Fail Criteria
PM passes when:
Correct PM type and checklist are used.
Required cleaning is completed.
Fluidic flush is completed.
Required pump cassettes are replaced.
Required tubing components are replaced.
Annual specimen filter replacement is completed when applicable.
Sampler calibration verification passes.
Tube detector verification passes.
Barcode scanner alignment verification passes.
SPA alignment verification passes.
Fluidic system is free of leaks and visible bubbles.
Optical bench verification passes.
Auto-Focus completes successfully.
Calibration REF is 1.4 to 2.7.
Positive Control runs are within range with CV < 5%.
Facility-required electrical safety testing passes, if performed.
Remove from service if:
Analyzer fails Auto-Focus.
Calibration REF is outside 1.4 to 2.7.
Positive Control runs are out of range or CV is ≥ 5%.
Fluid leaks are present.
Persistent air bubbles remain in fluidic lines.
Pump cassette doors do not close properly.
Barcode scanner cannot reliably read labels.
Tube detector does not verify properly.
SPA alignment is unsafe or incorrect.
Flow Cell, optical bench, or fluidic components are damaged.
Electrical safety testing fails under facility criteria.
Copy/Paste CMMS Work Order Procedure
Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.