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Manual Reference
Nellcor Bedside SpO2 Patient Monitoring System PM100N Operator's Manual, applicable current edition available through Medtronic product manuals; applicable PM100N Service Manual; Covidien/Medtronic Field Safety Notice FA1489 dated June 2025 when applicable.
Manufacturer Recommendation / AEM Status
A qualified service technician should perform periodic safety checks every 24 months:
- Inspect for mechanical and functional damage or deterioration.
- Inspect safety-relevant labels for legibility.
- Ensure all user-interface keys, cables, and accessories function normally.
Surface-clean periodically, regularly check battery condition, charge the battery after six months without use, and have qualified service replace the lithium-ion battery at least every two years. Follow manufacturer instructions for long-term storage and battery removal. The monitoring system requires no calibration; routine service is limited to cleaning, battery maintenance, and institution-mandated activities.
Alarm-Volume Safety Notice
Covidien/Medtronic Field Safety Notice FA1489, dated June 2025, concerns verification of alarm-volume settings for PM100N and model 10005941 after reports of alarms not being heard. Verify applicability and facility completion of the current corrective action before return to service. Follow the current manufacturer notice and facility field-action process; this PM summary does not replace those instructions.
Any change to the 24-month interval or activities should be managed under the approved AEM program, risk assessment, maintenance history, field-action status, and applicable requirements.
What This PM Procedure Covers
- Identification, configuration, and field-action status.
- Physical, label, cord, connector, cable, sensor, accessory, and mounting inspection.
- Cleaning, AC power, battery maintenance, and two-year replacement review.
- POST, display, keys, indicators, speaker, alarms, and oximetry verification.
- Nurse-call testing when applicable.
- Electrical safety and return-to-service determination.
Required Tools and Equipment
- Commercial nonabrasive cleaner and soft cloth.
- Electrical safety analyzer capable of ground-integrity, earth-leakage, touch-current, and patient-leakage tests.
- Nellcor-compatible pulse-oximeter simulator and interface cable.
- Compatible Nellcor sensor and cable.
- Known-good grounded AC outlet and approved power cord.
- Manufacturer-approved lithium-ion battery when replacement is due; qualified-service replacement required.
- Nurse-call test connection when used.
- Current PM100N manuals and FA1489 instructions.
- Facility-required personal protective equipment.
Step-by-Step PM Procedure
1. Confirm Identification, Configuration, and Safety-Action Status
Action: Verify asset tag, serial number, model, battery configuration, power cord, sensors/cables, nurse-call use, mounting accessories, software/configuration when available, and CMMS record. Check FA1489 applicability and completion status through the facility field-action process.
Expected outcome: The device matches its record and no unresolved recall or field-safety action prevents use.
2. Remove the Monitor From Clinical Use
Action: Transfer monitoring if needed. Power off, disconnect the patient and AC power, and remove accessories as needed.
Expected outcome: Maintenance can proceed without interrupting patient monitoring.
3. Perform the 24-Month Physical and Label Inspection
Action: Inspect the enclosure, display, keys, speaker openings, indicators, inlet, cord/plug/earth pin, sensor connector, data/nurse-call ports, battery compartment, mounting points, stand/adapter, cables, sensor, and accessories for damage, deterioration, contamination, loose parts, liquid intrusion, heat, or strain. Check safety labels for presence and legibility.
Expected outcome: No mechanical, electrical, functional, accessory, or label defect is present.
4. Clean and Dry the Monitoring System
Action: Remove the battery before cleaning when required by the applicable service procedure. Lightly wipe top, bottom, and front surfaces with a soft cloth dampened with commercial nonabrasive cleaner. Follow each sensor's instructions. Do not spray, pour, or spill liquid onto the monitor or openings. Thoroughly dry; refer for examination if spill-related safety is uncertain.
Expected outcome: The system and reusable accessories are clean, dry, and undamaged.
5. Inspect AC Power and Charging Operation
Action: Connect the approved cord to a known-good grounded outlet. Verify AC Power and Battery Charge indicators. Check stability while gently manipulating normal external connections.
Expected outcome: AC power and charging indication are stable.
6. Review Battery Maintenance and Replacement Status
Action: Inspect age, condition, fuel gauge, charging, service history, and deep-discharge data when available. Fully charge. Have qualified service replace the battery if two years old, damaged, unreliable, rapidly depleted, or failed. Charge after six months without use and follow storage/removal instructions.
Expected outcome: Battery maintenance is current and the two-year replacement requirement is satisfied.
7. Verify Battery Operation
Action: With a full battery and the monitor operating, disconnect AC. Verify the AC indicator turns off and battery operation begins without restart, interruption, or immediate low-battery warning. Reconnect AC and verify charging resumes. Do not invent a runtime threshold without an applicable approved procedure.
Expected outcome: AC/battery transfer and battery operation are stable.
8. Perform Power-On Self-Test and User-Interface Checks
Action: Power-cycle the monitor. Verify POST, display, indicators, keys, menus, pulse tone, alarm speaker, and configured controls. Confirm date/time and approved settings without unauthorized changes.
Expected outcome: POST and all user-interface functions pass without an unresolved error.
9. Verify SpO2 and Pulse-Rate Function
Action: Connect an approved Nellcor-compatible simulator and test at facility-approved points supported by the simulator and applicable service manual. Verify SpO2, pulse rate, pleth/waveform, pulse indication, and signal status. Record settings, expected criteria, and results. Do not use clinical sensor accuracy specifications as simulator tolerances unless explicitly directed.
Expected outcome: All selected test points meet documented criteria.
10. Verify Alarm Operation and Volume
Action: Create high- and low-priority physiological or technical alarms. Verify visible/audible indication, priority behavior, pause/silence, and restoration. Confirm volume is audible at applicable approved settings and configuration complies with current FA1489 instructions when applicable. Restore all original/facility-approved limits and volume.
Expected outcome: Alarms are visible and audible, controls work, field-action requirements are met, and settings are restored.
11. Verify Nurse Call When Equipped and Used
Action: Create an alarm and confirm nurse-call activation. Local audible/visual alarms remain the primary notification source. Restore connections/settings.
Expected outcome: Nurse call activates reliably.
12. Perform Electrical Safety Testing
Action: Test using the applicable manual edition, analyzer instructions, and facility policy. The reviewed later-edition operator manual lists:
- Ground integrity: 100 milliohms (0.1 ohm) or less.
- Earth leakage: 5 mA normal; 10 mA single fault, normal and reversed polarity.
- Touch current: 100 microamps normal; 500 microamps single fault, normal and reversed polarity.
- Patient leakage: 100 microamps normal; 500 microamps single fault, normal and reversed polarity.
- Patient leakage with mains on applied part: 5000 microamps single fault.
Manual revisions can differ. Confirm these limits match the exact applicable edition and regional configuration; use applicable manufacturer/facility criteria if different.
Expected outcome: Every required safety test passes.
13. Complete the Return-to-Service Review
Action: Confirm inspection, labels, cleaning, power/charging, battery, POST, controls, oximetry, alarms/volume, nurse call, electrical safety, settings restoration, and field-action status all pass.
Expected outcome: The PM100N is ready to return to service.
Electrical Safety Testing
Electrical safety testing applies because the PM100N connects to AC mains. Record exact analyzer results and applicable limits. Do not return the monitor after a failed ground-integrity, leakage-current, power-cord, or enclosure-safety test.
Pass / Fail Criteria
PM Pass Criteria
- 24-month physical, functional, accessory, and label inspections pass.
- Monitor and accessories are clean, dry, and undamaged.
- AC power, charging, battery transition, and battery operation are stable.
- Battery replacement is current at two years.
- POST, display, controls, indicators, and speaker pass.
- Simulator checks pass documented criteria.
- Alarms, volume, pause/silence, and restoration pass.
- FA1489 action is complete when applicable.
- Nurse call passes when applicable.
- Ground integrity and leakage tests pass applicable limits.
- Settings are restored with no unresolved error or complaint.
Remove From Service Criteria
- Damage, deterioration, illegible labels, liquid intrusion, overheating, or accessory damage affects safety/performance.
- AC power, charging, battery transition, or battery operation is unreliable.
- Battery is overdue or fails checks.
- POST, controls, display, indicators, speaker, oximetry, alarms, or nurse call fails.
- Alarm volume is unreliable or FA1489 action remains unresolved.
- Electrical safety fails.
- Settings cannot be restored or an error/complaint remains unresolved.
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.