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Asset Type
Manufacturer
Model
Level 1 Series H-1000 / H-1200
Manual Reference
Level 1 H-1200 Operator's Manual P/N 4533708GB Rev. 008; H-1000 Operator's and Service Manual P/N 4533801 Rev. 001; current ICU Medical guidance.
Manufacturer Recommendation / AEM Status
Clean and inspect before every use; lubricate O-rings and replace distilled water every 30 days; annually disinfect/service the reservoir, replace O-rings, clean the fan filter, inspect options, and perform alarm, performance, calibration, and electrical-safety tests. When using 0.3% hydrogen-peroxide/distilled-water solution, replace it every 12 months and top off with the same solution. H-31 air detector/clamp and H-2 pressure-chamber checks apply only when fitted.
Changes belong under the facility's approved AEM program, risk assessment, maintenance history, and applicable requirements.
What This PM Procedure Covers
- Structure, reservoir, heat exchanger, O-rings, drain, fan/filter, cord, ground, and accessories
- H-2 chambers and H-31B detector/clamp when fitted
- Before-use, 30-day, and annual maintenance
- Alarm, cold-start, performance, and temperature testing
- Earth leakage and ground continuity
Required Tools and Equipment
- Current manuals and approved test disposable
- Distilled water; 0.3% solution made from 140 mL 3% hydrogen peroxide plus 1,260 mL distilled water when applicable
- Approved silicone lubricant, replacement O-rings, filter-cleaning supplies, soft cloth, and approved cleaners
- Level 1 Thermal Calibration Well 80-03-002 with required filter or current approved calibration setup
- Calibrated reference/timer and electrical safety analyzer
Step-by-Step PM Procedure
1. Verify Identity and Configuration
Action: Record asset, H-1000/H-1200, serial, voltage, H-2/H-31B options, disposable family, and manual.
Expected outcome: Requirements match the unit.
2. Review History
Action: Review heat, alarms, temperature, leaks, flow, detector/clamp, chambers, reservoir, safety, and repairs.
Expected outcome: Risks are known.
3. Remove From Use
Action: Tag out, remove disposables, unplug/cool/depressurize, and follow contamination policy.
Expected outcome: Burn, pressure, shock, and biohazards are controlled.
4. Clean Exterior
Action: Clean after use with approved mild detergent, water, soft cloth, and disinfection method; prevent ingress and dry.
Expected outcome: Surfaces are clean and intact.
5. General Inspection
Action: Inspect enclosure, pole clamp, feet, handles, labels, display, controls, fill port, drain, tubing, cables, and fasteners.
Expected outcome: Structure is complete; damaged units are removed.
6. Inspect Power Components
Action: Inspect cord, plug, ground pin, inlet, strain relief, protection, and accessible connectors.
Expected outcome: Mains and ground parts are intact.
7. Inspect Sockets and O-Rings
Action: Check sockets/seals for cuts, flattening, dryness, swelling, contamination, leakage, or difficult insertion.
Expected outcome: Seals are intact and seat smoothly.
8. Complete 30-Day Lubrication
Action: Apply a small amount of specified silicone grease around each O-ring without unnecessary disassembly.
Expected outcome: Seals are lightly/evenly lubricated.
9. Service Recirculating Solution
Action: Replace distilled water every 30 days, or maintain/top off 0.3% solution with the same mixture and replace annually.
Expected outcome: Correct solution and level are documented.
10. Complete Annual Reservoir Disinfection
Action: Follow exact drain/fill/circulation/dwell/refill steps using 1.4 L of 0.3% solution: 140 mL 3% hydrogen peroxide plus 1,260 mL distilled water.
Expected outcome: Annual protocol is complete.
11. Replace O-Rings Annually
Action: Replace specified O-rings, lubricate, seat fully, and leak-check.
Expected outcome: New seals are correctly installed.
12. Clean Fan Filter Annually
Action: Remove/clean/dry/reinstall the filter and inspect guard/air path.
Expected outcome: Cooling airflow is unobstructed.
13. Inspect H-2 Pressure Chambers
Action: If fitted, inspect chambers, latches, hinges, connections, controls, and operation.
Expected outcome: Chambers are secure and functional.
14. Inspect H-31B Air Detector/Clamp
Action: If fitted, inspect detector, clamp, cable, connector, action, indicators, and disposable seating.
Expected outcome: Detector/clamp is clean, aligned, and functional.
15. Test Add-Water and Disposable Alarms
Action: Perform manual-prescribed alarm simulations and recovery.
Expected outcome: Audible/visual alarms activate and clear.
16. Test Detector/Clamp and Alarm Output
Action: If fitted, test air detection, clamp action, and Fluid Warmer Alarm Signal output.
Expected outcome: Air hazard stops flow and signals correctly.
17. Test Overtemperature Protection
Action: Perform only the controlled manual procedure; never improvise heating.
Expected outcome: Heat interrupts and alarm/indication passes.
18. Perform Cold-Start and Performance Tests
Action: With approved test setup, verify circulation, warm-up, flow path, controls, indicators, and stable operation.
Expected outcome: Performance passes without leak/fault.
19. Verify Calibration and Electrical Safety
Action: Use TCW 80-03-002/approved setup; display must be within 0.3°C of reference. Test earth leakage with heater fully on and ground continuity.
Expected outcome: Calibration and safety pass.
20. Restore and Document
Action: Remove test set, restore solution/options, clean/dry, repeat readiness, label, and document values/parts/status.
Expected outcome: Unit is complete and ready or removed.
Electrical Safety Testing
Perform earth leakage with the immersion-heater circuit fully on and ground continuity per current manual/standard. Record analyzer/calibration, configuration, leakage conditions/value/limit, ground value/limit, any specifically required dielectric test, and pass/fail.
Pass / Fail Criteria
Pass
- Structure, seals, solution, filter, power/ground, controls, options, alarms, clamp, performance, and electrical safety pass
- Displayed temperature is within 0.3°C of the approved reference
Remove From Service
- Damage, leak, contamination, incorrect solution, failed alarm/clamp/overtemperature protection, unstable heat, calibration beyond 0.3°C, electrical failure, or incomplete authorized repair
Copy/Paste CMMS Work Order Procedure
Use current model-specific manuals. Never bypass alarms, clamps, temperature protection, grounding, or use an unapproved solution/disposable. Route internal repair to authorized service.