On this page
Asset Type
Manufacturer
Model
Models Covered
Masimo Rad-97 Pulse CO-Oximeter, including the base model, Rad-97 with noninvasive blood pressure, and Rad-97 with NomoLine capnography. The service manual covers Version 1 and Version 2 hardware. Identify the version, installed measurement technologies, patient population profiles, connectivity, and accessories before testing; document absent options as not applicable.
Manual Reference
Masimo Service Manual, Rad-97, document 39878/LAB-10044C-0223, 2023; and Masimo Rad-97 Operator's Manual, document 301262/LAB-9275K-0321. Use the latest revision listed in Masimo's official technical-document library for the device configuration.
Manufacturer Recommendation / AEM Status
Masimo states that safety checks should be performed at regular intervals or as required by local and governmental regulations. The NIBP calibration should be verified annually, and NomoLine capnography requires a leakage check and gas-reading verification once every year or whenever gas readings are questionable. Clean the device when visibly dirty, before and after each procedure, and/or according to hospital practice. No internal adjustment or recalibration is required during normal operation. This procedure uses an annual comprehensive PM interval to capture the manufacturer-listed annual option checks; facilities must define the base-model interval under their approved maintenance program and may not extend applicable annual checks without a documented AEM assessment.
What This PM Procedure Covers
- Identity, hardware version, installed options, software, accessories, service history, cleaning, enclosure, connectors, labels, and Version 1 vent care
- Power-on self-test, status indicators, touchscreen gestures, speaker, charging, battery health, and battery-runtime assessment
- Masimo SET tester verification, active parameter displays, alarm limits, sensor/accessory recognition, and restoration
- Annual NIBP static-pressure verification, pneumatic leakage, and adult/pediatric and neonatal overpressure protection when NIBP is installed
- Annual NomoLine leakage and gas-reading verification when capnography is installed
- Nurse-call contact operation, configured connectivity, IEC 60601-1 electrical safety, pass/fail, and CMMS documentation
Required Tools and Equipment
- Current Masimo Rad-97 service and operator manuals and facility PM form
- Compatible Masimo SET Tester with its current directions for use and approved patient cable
- Calibrated manometer verified within the last 12 months, with calibration accuracy of ±0.02% to ±0.25% full scale and measurement uncertainty of ±1 least-significant digit
- Pneumatic T adapters, connection tubing, hand bulb, and 500 mL rigid volume or correctly wrapped cuff/solid object for applicable NIBP tests
- Adult/pediatric and neonatal NIBP test setup when both profiles are enabled
- NomoLine sampling line, 3/32-inch (2.4 mm) inner-diameter silicone tubing, and the current NomoLine ISA maintenance-kit procedure/reference gas equipment when capnography is installed
- Calibrated IEC 60601-1 electrical-safety analyzer and digital multimeter
- Compatible 2-circuit or 3-circuit nurse-call test cable when nurse call is configured
- Approved cleaning solution, fresh wipes or soft lint-free cloths, and a small vacuum with brush attachment for Version 1 vents
Step-by-Step PM Procedure
1. Remove the Device From Clinical Use
Action: Confirm the Rad-97 is not monitoring a patient, place it under service control, disconnect patient sensors and accessories, and move it to an insulating bench surface. Before cleaning, power it off and physically disconnect AC power and all patient connections.
Expected outcome: The device is safely isolated for inspection and testing.
2. Verify Identity, Version, and Configuration
Action: Record asset tag, serial number, software revision, department, PM due date, enabled parameters, patient profiles, connectivity, nurse call, battery configuration, and installed NIBP or NomoLine module. Identify Version 1 by three rear vent columns and Version 2 by two rear vent columns.
Expected outcome: The physical device, site model record, manuals, and option-specific test plan agree.
3. Review Service History
Action: Review prior PMs, repairs, alarms, battery/runtime complaints, drops, liquid exposure, sensor-recognition problems, NIBP accuracy/leak complaints, questionable gas readings, touchscreen faults, network issues, and service actions. Resolve active corrective-maintenance concerns before PM completion.
Expected outcome: Repeat faults and unresolved safety issues are identified before performance testing.
4. Clean and Dry the Rad-97
Action: Wipe exterior surfaces twice or until visibly clean using only a current Masimo-approved agent and a dampened soft cloth/wipe; use a fresh wipe for the second pass and allow thorough drying. Do not immerse, sterilize, use undiluted bleach, use harsh solvents, or allow liquid into the device. Keep a sampling line fitted while cleaning a NomoLine adapter. On Version 1 only, vacuum vent debris with a small brush attachment; Version 2 does not use that vent-cleaning step.
Expected outcome: The device is visibly clean, dry, residue-free, and free of fluid ingress or blocked Version 1 vents.
5. Perform Visual and Mechanical Inspection
Action: Inspect housing, touchscreen, home/power button, status light, feet, vents, AC inlet and Masimo cord, equipotential post, patient-cable connector, NIBP port/cuff/hose, NomoLine inlet/exhaust, nurse-call/USB/Ethernet ports, labels, sensors, cables, and accessories. Look for cracks, contamination, corrosion, bent pins, loose parts, strain-relief damage, swelling, overheating, or unreadable markings.
Expected outcome: No damage, contamination, loose connection, blocked opening, or unsafe accessory remains.
6. Verify Power-On Self-Test, Touchscreen, and Audio
Action: Connect AC power and confirm the AC/charge indication. Power on the Rad-97. Within five seconds, verify available indicators illuminate, a tone sounds, and the Masimo logo appears. Exercise touch, touch-and-hold, swipe, flick, pinch, and drag-and-drop gestures where supported. Increase and decrease alarm and pulse-tone volumes.
Expected outcome: POST completes without a system-failure alarm, the display and touchscreen respond over the usable area, and speaker level changes track the selected setting.
7. Inspect Charging and Battery Performance
Action: Verify charging indication with the device on and off, battery icon/status, secure AC connection, and battery operation after disconnecting AC. Review battery health using the authorized service workflow without recording access credentials. Recharge a battery that has not been charged for one month or more. When facility policy requires a capacity test, fully charge the battery and verify at least 2 hours of operation under the manual's stated high-load configuration: AC disconnected, wireless and Bluetooth connected, and brightness at maximum.
Expected outcome: Charging and battery indications are normal, no battery fault is present, and documented runtime meets the applicable requirement. Significantly reduced runtime requires a full discharge/recharge assessment and replacement or service if unresolved.
8. Verify Masimo SET Measurement Operation
Action: Connect the approved patient cable and compatible Masimo SET Tester. Follow the tester's current directions for use and verify the Rad-97 recognizes the test input, displays the expected SpO₂ and pulse-rate information, produces stable signal-quality indication, and reports no unexpected sensor or cable fault. Test other enabled rainbow parameters only with compatible approved test equipment.
Expected outcome: All tester-generated values and indicators meet the tester's documented acceptance criteria and remain stable.
9. Verify Alarms and Active Parameters
Action: Establish valid measurement data using an approved tester or the operator-manual method. Move the high SpO₂ alarm limit below the current value, verify the limit display and alarm response, then restore it. Repeat for each active parameter and confirm visual/audible alarm, alarm silence/pause, status light, and message behavior.
Expected outcome: Every active parameter alarm responds correctly and all original alarm settings are restored.
10. Verify Annual NIBP Static Pressure Accuracy
Action: If NIBP is installed, connect the calibrated manometer, 500 mL rigid volume or cuff around a solid object, hand bulb, tubing, and T adapters. Through authorized service access, start the calibration test and compare multiple points from 0 to 280 mmHg. Verify before calibrating; perform zero/span calibration only after a failed accuracy test.
Expected outcome: Static pressure accuracy is within ±3 mmHg or 2% of the reading, whichever is greater; the service procedure expects monitor-to-manometer agreement within ±3 mmHg at tested points. A result outside tolerance after authorized calibration requires Masimo service.
11. Test NIBP Pneumatic Leakage and Overpressure Protection
Action: Using the calibrated manometer and 500 mL rigid volume, run the NIBP air-leak test. Then use the correct patient profile and test setup to verify adult/pediatric and neonatal overpressure release. Never wrap the calibration/test cuff around a person.
Expected outcome: Pneumatic leakage is less than 6 mmHg/min. Overpressure release occurs at 300 ±10 mmHg for adult/pediatric profiles and 150 ±5 mmHg for the neonatal profile. Investigate external test-fixture leakage before condemning the module.
12. Verify Annual NomoLine Capnography Performance
Action: If NomoLine is installed, follow the current NomoLine ISA maintenance-kit procedure to verify gas readings with a reference instrument or calibration gas. Perform the operator-manual leakage check with a new sampling line: establish greater than 4.5 vol% or 34 mmHg CO₂, connect to the exhaust, allow one minute to stabilize, then compare after one additional minute.
Expected outcome: Gas readings meet the current NomoLine reference procedure and CO₂ decreases by no more than 0.4 vol% or 3 mmHg in one minute. A larger decrease is a major leak and the capnography function must not be used.
13. Verify Nurse Call and Configured Connectivity
Action: When nurse call is used, verify normal polarity and test the installed 2- or 3-circuit cable with a DMM before any hospital-system connection. Confirm normally open/closed states and trigger an alarm. Verify Ethernet, wireless, Bluetooth, USB, patient-record, or central-system functions required by the site configuration without leaving test data in a clinical record.
Expected outcome: Nurse-call triggered contacts measure less than 25 Ω and open states read OL; configured data connections operate reliably and identify the correct device.
14. Complete Electrical Safety Tests
Action: Perform the applicable Class I/Type BF tests in the Electrical Safety Testing section with calibrated equipment. Electrical-safety testing is required after battery or TB-20 replacement and at regular/local regulatory intervals. Record all conditions and readings.
Expected outcome: Ground continuity is stable and every leakage result is at or below its applicable limit.
15. Restore, Final-Check, and Document
Action: Disconnect test equipment, reinstall approved accessories, restore patient profile, alarms, sounds, brightness, network, nurse-call polarity, and other site settings. Verify date/time, complete a final startup, remove test records, clean the exterior, and document equipment IDs, readings, option-specific N/A items, parts, corrective action, and disposition.
Expected outcome: The Rad-97 is complete, correctly configured, traceable, and either returned to service or clearly removed from service.
Electrical Safety Testing
Masimo classifies the Rad-97 as internally powered with a Type BF applied part when disconnected from AC and as Class I with a Type BF applied part when connected to AC. Follow the current service-manual matrix and analyzer instructions at 120 or 240 VAC, 50/60 Hz.
- Outlet, cord, and earth path: Verify outlet wiring and ratings, inspect the Masimo power cord, confirm line/neutral/earth continuity if in doubt, and verify stable continuity from the equipotential post or accessible earthed metal to the cord earth pin.
- Earth leakage: Maximum 5 mA in normal condition and 10 mA in the listed single-fault condition.
- Touch leakage: Maximum 100 µA in normal condition and 500 µA in the listed single-fault conditions.
- Patient leakage: Maximum 100 µA in normal condition and 500 µA in the listed single-fault conditions using the applicable patient connection.
Use the service manual's polarity, neutral, earth, power-state, and measuring-device conditions. Any unstable earth path or value above its applicable limit is a failure.
Pass / Fail Criteria
PM Pass Criteria
- Correct Rad-97 identity/version/configuration; cleaning, housing, display, labels, connectors, cables, sensors, accessories, vents, and controls pass
- POST, touchscreen gestures, speaker, charge indications, battery operation, alarms, active parameters, Masimo SET tester, and configured connectivity pass
- When NIBP is installed: static accuracy meets the OEM limit, leakage is below 6 mmHg/min, and overpressure release is 300 ±10 mmHg adult/pediatric and 150 ±5 mmHg neonatal
- When NomoLine is installed: annual gas verification passes and leakage does not exceed 0.4 vol% or 3 mmHg in one minute
- When nurse call is installed: closed/triggered contacts are below 25 Ω and open states read OL
- Earth continuity is stable and earth, touch, and patient leakage readings meet the applicable OEM limits
- Original settings are restored and all readings, test-equipment IDs, N/A options, service actions, and disposition are documented
Remove From Service Criteria
- Cracked, wet, contaminated, loose, corroded, swollen, overheated, or otherwise unsafe enclosure, battery, cord, connector, sensor, cable, or accessory
- POST, touchscreen, audio, alarm, measurement, charging, battery, NIBP, capnography, nurse-call, or connectivity failure remains unresolved
- NIBP remains outside tolerance after authorized calibration, pneumatic leakage is excessive, or overpressure protection fails
- NomoLine has a major leak or questionable gas readings cannot be verified
- Ground continuity is intermittent or any leakage-current reading exceeds its applicable limit
Copy/Paste CMMS Work Order Procedure
Use current Masimo documentation and qualified service personnel. Do not publish or record service-access credentials, do not perform pneumatic tests on a person, and do not return a Rad-97 with an unresolved measurement, alarm, battery, NIBP, capnography, connectivity, or electrical-safety failure to clinical use.