Siemens Healthineers CLINITEK Status+

Asset Type

Urine Analyzer

Manufacturer

Siemens Healthineers

Model

CLINITEK Status+

Manual Reference

Bayer CLINITEK Status Operation / Service Manual

Manufacturer Recommendation / AEM Status

Manufacturer-listed PM items

The provided manual lists preventive maintenance around cleaning, inspection, and routine checks of the CLINITEK Status analyzer.

Manufacturer-listed items include:

• Wear disposable surgical gloves when working with reagents, fluids, or cleaning the instrument.
• Place cleaning or disposable items in a biohazard bag.
• Clean the test table insert, strip channel, surrounding area, and drip tray.
• Examine the calibration strip for dust, dirt, scratches, or mars.
• Do not touch the calibration strip.
• Clean the calibration strip only with a new cotton-tipped applicator and distilled water if it appears dirty.
• Replace the test table if the calibration strip cannot be cleaned, is scratched, or is marred.
• Disinfect the test table and test table insert when needed using listed solutions.
• Keep the outside of the instrument free of dust, dirt, and urine.
• Prevent liquid from entering the printer compartment.
• No lubrication is needed on the test table teeth or drive gear.

Manufacturer-listed frequencies

• Daily: Clean the test table insert, strip channel, surrounding area, drip tray, and inspect the calibration strip.
• As needed: Disinfect the test table and insert.
• As needed: Remove heavy buildup using 0.1N sodium hydroxide, avoiding contact with the white calibration strip.
• Scheduled BMET PM interval: Not specified in the provided manual.
• Service / post-repair release testing: Listed for instruments after service before return to the service pool.

Manufacturer-listed parts / materials

• CLINITEK Status Check Cassette: PN 9333.
• Printer paper: Ludlow C-696, 5.8 cm width, 2500 cm length.
• The manual lists the Check Cassette as a hardware test tool, not a performance control.

Post-repair safety / release requirements

The manual lists release testing after service, including:

• Decontaminate instrument per operator manual and local procedures.
• Confirm original complaint.
• Physically examine outside of instrument and test table.
• For performance complaints, run a CLINITEK Status Check Cassette followed by Bayer Chek-Stix positive and negative controls.
• Perform display diagnostics.
• Perform touch screen diagnostics.
• Perform test table diagnostics.
• Check software version and update if needed.
• Connect serial null modem cable to the 9-pin connector and run Service ATE release testing.
• Service ATE items listed: 11-way strip, 7-way strip, mirror strip for light ingress, four Munsell standard strips, Ronchi strip for optical resolution, and CLINITEK Status Check Cassette.
• If ATE fails, troubleshoot/repair and retest before release.

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

• Visual inspection
• Test table and insert cleaning
• Calibration strip inspection
• Approved disinfection approach
• Basic functional checks
• Electrical safety documentation fields
• Post-service release testing documentation when applicable
• Copy/paste CMMS documentation

Required Tools and Equipment

• Disposable surgical gloves
• Biohazard bag
• Cotton-tipped applicators
• Distilled water
• Soft lint-free cloth or tissue
• Running water source
• Mild detergent, if cleaning exterior
• Approved disinfectant, if disinfection is needed:
  • Precept
  • Cidex 3.2% glutaraldehyde solution
  • Amphyl liquid
  • Theracide liquid
  • Household bleach, 5% sodium hypochlorite, full strength or diluted up to 20:1
  • Isopropyl alcohol, 70% to 85% or undiluted
• 0.1N sodium hydroxide, only for heavy dried urine buildup
• Electrical safety analyzer, if required by facility policy
• CLINITEK Status Check Cassette PN 9333, if performing hardware diagnostic or post-service checks
• Bayer Chek-Stix positive and negative controls, if evaluating performance complaint or post-service release
• Serial null modem cable and Service ATE setup, if performing manufacturer-style release testing after service

Step-by-Step PM Procedure

1. Confirm Device Status

Action: Confirm the analyzer is not actively being used for patient testing. Notify the department that PM is being performed.

Expected outcome: No active urine strip or cassette test is interrupted.

2. External Visual Inspection

Action: Inspect the analyzer housing, touchscreen, printer cover, power connection, RS-232 connector, battery compartment, and test table opening. Look for cracks, missing parts, fluid intrusion, dried urine, damaged connectors, or printer compartment contamination.

Expected outcome: Analyzer is physically intact, cleanable, and safe to handle.

3. Remove and Inspect Test Table / Insert

Action: With power on, gently pull the test table carriage from the instrument. Remove the test table insert and drain the drip tray if required.

Expected outcome: Test table and insert are removable and not physically damaged.

4. Inspect Calibration Strip

Action: Examine the white calibration strip for dust, dirt, scratches, or mars. Do not touch the calibration strip.

Expected outcome: Calibration strip is clean and undamaged.

Fail condition: If the calibration strip cannot be cleaned, is scratched, or is marred, replace the test table before returning the analyzer to service.

5. Clean Test Table Insert and Drip Tray

Action: Using a cotton-tipped applicator and distilled water, scrub the strip channel, surrounding area, and drip tray. Rinse the test table insert under running water. Dry with a soft lint-free cloth or tissue.

Expected outcome: Insert, strip channel, and drip tray are clean and dry.

6. Clean Calibration Strip If Needed

Action: If the calibration strip appears dirty, gently clean it with a new cotton-tipped applicator and distilled water. Allow it to air dry and inspect again.

Expected outcome: Calibration strip is clean, dry, and undamaged.

Fail condition: Replace the test table if the calibration strip cannot be cleaned or shows scratches/marring.

7. Disinfect Test Table and Insert If Needed

Action: If disinfection is required, use only a manufacturer-listed disinfectant. Do not allow disinfectant to contact the white calibration strip. Soak the table or insert for no longer than 10 minutes, rinse thoroughly with water, dry, and reinstall.

Expected outcome: Table and insert are disinfected without damaging the calibration strip.

8. Remove Heavy Buildup If Present

Action: If dried urine buildup is present, wet a cotton-tipped applicator with 0.1N sodium hydroxide and clean the strip holding channel, surrounding areas, drip tray, and table insert. Do not allow sodium hydroxide to contact the white calibration strip. Rinse thoroughly and dry.

Expected outcome: Heavy buildup is removed without damage to the calibration strip.

9. Clean Exterior

Action: Turn the instrument off by pressing the power button for 2 seconds. Wipe the exterior using a damp cloth with mild detergent or a listed disinfectant. Do not allow liquid into the printer compartment.

Expected outcome: Exterior is clean, dry, and free of visible urine, dust, or dirt.

10. Reinstall Test Table and Insert

Action: Reinstall the test table and insert by gently pushing the table into the instrument until halfway in.

Expected outcome: Table inserts smoothly and is properly seated.

11. Functional Check

Action: Power the analyzer on and confirm it reaches the ready/select screen. Confirm the touchscreen responds, display is readable, printer has paper if used, and test table movement appears normal.

Expected outcome: Analyzer powers on normally and basic user-interface functions operate.

12. Optional Diagnostic Checks

Action: If facility PM policy includes diagnostics, or if there was a related complaint, run applicable diagnostics from the instrument diagnostic menu:

• Display diagnostic
• Touch screen diagnostic
• Printer diagnostic
• Test table diagnostic
• Light source diagnostic
• Electronics diagnostic
• Check Cassette diagnostic using PN 9333, when appropriate

Expected outcome: Applicable diagnostics pass.

Fail condition: Failed diagnostics require troubleshooting, repair, or removal from service.

Electrical Safety Testing if applicable

The provided manual lists line leakage current as 170 microamperes in normal condition and states that the power supply is double insulated with no leakage in fault condition. The manual does not list a routine PM electrical safety test interval.

Use facility policy for electrical safety testing frequency and limits.

Ground resistance

Not applicable unless facility policy identifies a protective earth test point. The power supply is listed as double insulated.

Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different.

Result = N/A / measured result =

Touch/chassis leakage

Touch/chassis leakage measured in microamps:

Facility limit used =

Result =

Pass / Fail =

Power supply line leakage, if tested

Manual-listed normal condition reference = 170 µA

Result =

Pass / Fail =

Pass / Fail Criteria

PM passes when:

• Analyzer is clean and dry.
• Test table and insert are clean and properly seated.
• Calibration strip is clean, dry, and not scratched or marred.
• No liquid intrusion or printer compartment contamination is found.
• Power-on check passes.
• Touchscreen/display/printer/table functions operate as expected, if checked.
• Electrical safety testing passes facility criteria, if performed.
• Any facility-required QC or diagnostic checks pass.

Remove from service when:

• Calibration strip is scratched, marred, damaged, or cannot be cleaned.
• Test table teeth are damaged or table movement is abnormal.
• Analyzer fails power-on, display, touchscreen, printer, table, light source, electronics, or Check Cassette diagnostics.
• Fluid intrusion is suspected.
• Electrical safety testing fails facility criteria.
• Post-service release testing fails.
• Any Check Cassette failed test/error indicates instrument service is required.

Optional Short Procedure Block - Scheduled PM

Optional Short Procedure Block - Post-Repair Safety / Release Inspection

Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.