Masimo Rad-5

Asset Type

Pulse Oximeter

Manufacturer

Masimo

Model

Rad-5

Manual Reference

Masimo Rad-5/5v Operator's Manual, LAB-5724H, order number 33606, revision date March 10, 2022.

Manufacturer Recommendation / AEM Status

The reviewed manual provides performance verification for use following repairs or during routine maintenance but does not specify a calendar-based preventive-maintenance interval.

• Clean the device using only listed methods and dry thoroughly.
• Use four AA alkaline batteries, each no greater than 1.5 V; remove them if the unit will not be used for some time.
• Before verification, verify or install new batteries and disconnect patient, sensor, and serial cables.
• Perform the Power-On Self-Test and test every non-Power key.
• Verify all four Rad-5 alarm-limit controls and restore their original settings.
• Cycle through all four LED brightness levels.
• Use a Masimo SET Tester for the manufacturer-listed functional checks.
• Discontinue use if any test fails. Perform only maintenance described in the manual and refer other service to Masimo or an authorized department.

If the facility establishes an interval, manage it through its approved AEM program, risk assessment, maintenance history, clinical use, and applicable requirements.

What This PM Procedure Covers

• Physical, cable, sensor, connector, and battery inspection.
• Manufacturer-approved cleaning.
• Battery replacement when needed.
• Power-On Self-Test and key-response testing.
• Alarm-limit and display-brightness testing.
• Masimo SET Tester functional verification.
• Alarm, silence, timeout, and pulse-tone-volume checks.
• Return-to-service determination.

Required Tools and Equipment

• Four new AA alkaline batteries when needed; do not use cells greater than 1.5 V.
• Masimo SET Tester.
• Compatible Masimo-authorized patient cable and sensor.
• Soft cloth.
• Mild detergent and warm water, or a manual-listed agent: 70% IPA; 10% bleach/water solution (approximately 0.5% sodium hypochlorite); up to 55% alcohol/0.5% quaternary ammonium chloride solution; Oxivir Tb; or Cidex Plus (3.4% glutaraldehyde).
• Facility-required personal protective equipment.

Do not use undiluted bleach or an unlisted solution. Do not soak, immerse, irradiate, steam sterilize, autoclave, or use ethylene oxide on the device.

Step-by-Step PM Procedure

1. Confirm Device Identification and Configuration

Action: Verify the asset tag, serial number, manufacturer, model, accessories, sensor and cable type, and CMMS record. Confirm this is a Rad-5, not the alarm-free Rad-5v.

Expected outcome: The device matches its record and Rad-5-specific alarm tests apply.

2. Remove the Device From Clinical Use

Action: Confirm the device is not monitoring a patient. Turn it off and disconnect the sensor, patient cable, and serial cable.

Expected outcome: The Rad-5 is ready for safe maintenance.

3. Perform a Physical Inspection

Action: Inspect the case, displays, LEDs, buttons, speaker openings, connectors, battery cover/latch, battery compartment/contacts, patient cable, sensor, and accessories for cracks, contamination, corrosion, leakage, damaged contacts, loose parts, or liquid intrusion. Do not lift by the patient cable or open the case beyond battery replacement.

Expected outcome: No unsafe, damaged, contaminated, or unreliable condition is present.

4. Clean and Dry the Device

Action: With the device off, patient disconnected, and batteries removed, wipe outer surfaces twice or until free of visible residue using a dampened soft cloth with mild detergent/warm water or a listed agent. Prevent liquid entry and dry thoroughly. Do not use abrasives, instruments, brushes, or rough materials on displays.

Expected outcome: The device is visibly clean, completely dry, and undamaged.

5. Inspect and Install the Batteries

Action: Inspect for leakage, corrosion, or damage. Install four new or verified AA alkaline batteries in the marked orientation. Do not use non-alkaline batteries or cells greater than 1.5 V. Lock the cover securely.

Expected outcome: A matched alkaline set is installed and the compartment is intact.

6. Perform the Power-On Self-Test

Action: With patient, sensor, and serial cables disconnected, press Power and observe the approximately five-second startup.

Expected outcome: All available LEDs illuminate, a brief beep sounds, and normal operation begins without a system-failure message.

7. Perform the Key Press Button Test

Action: Press every button except Power and verify an audible beep or appropriate display change.

Expected outcome: Every tested control is acknowledged consistently.

8. Perform the Rad-5 Alarm Limit Test

Action: Record the original settings. Enter the alarm menu, change the high SpO₂ limit two points below its current value, accept it, verify it displays, and restore it. Repeat the change/display/restore test for low SpO₂, high pulse rate, and low pulse rate. Confirm all four original limits are restored.

Expected outcome: All four alarm limits change, display, and restore correctly.

9. Test LED Brightness

Action: Use the applicable Rad-5 menu and Up/Down keys to cycle through all four brightness levels. Exit with Mode/Enter or normal timeout.

Expected outcome: All four levels are distinguishable and normal operation resumes.

10. Test With the Masimo SET Tester

Action: Power-cycle the oximeter and connect the Masimo SET Tester. Verify:

• A Signal IQ/pulse bar appears within 20 seconds.
• SpO₂ is 79% to 84%.
• Pulse rate is 55 bpm to 65 bpm.
• Setting the low SpO₂ limit to 90 produces an audible alarm and flashing SpO₂ and Alarm indicators.
• Pressing Alarm Silence once silences the alarm and flashes its indicator.
• After 120 seconds, silence times out, the alarm returns, and the indicator turns off.
• Up increases pulse-beep loudness; Down decreases it until off.

Restore the original alarm settings.

Expected outcome: All listed ranges, indicators, alarm behavior, timing, and volume controls pass.

Important limitation: A functional tester cannot assess Rad-5/5v accuracy. Record performance verification, not clinical accuracy calibration.

11. Perform Final Sensor and Operational Verification

Action: Disconnect the tester. Connect an authorized cable and sensor. Verify secure connections, sensor recognition, no unresolved messages, appropriate SpO₂ and pulse-rate display during a controlled non-patient check, Signal IQ/pulse-bar response, and audible pulse indication. Do not derive clinical accuracy tolerance from another ordinary oximeter or an uncontrolled human reading.

Expected outcome: The installed system recognizes the sensor and operates normally.

12. Complete the Return-to-Service Review

Action: Confirm every applicable step passes, all settings are restored, and no unresolved complaint remains.

Expected outcome: The Rad-5 is ready to return to service according to facility policy.

Electrical Safety Testing

The Rad-5 uses four AA batteries. The manual identifies it as a defibrillation-proof Type BF device but does not list protective-earth resistance or touch/chassis leakage testing in routine maintenance. Do not add inapplicable mains-powered limits. Evaluate separately powered test equipment under its own documentation and facility policy.

Pass / Fail Criteria

PM Pass Criteria

• Physical inspection and cleaning pass.
• Four appropriate AA alkaline batteries are installed.
• All LEDs, startup beep, and normal startup pass.
• Every non-Power key is acknowledged.
• All four alarm-limit controls and all four brightness levels pass.
• SET Tester produces Signal IQ/pulse bar within 20 seconds, 79% to 84% SpO₂, and 55 to 65 bpm.
• Low-SpO₂ alarm, indicators, silence, 120-second timeout, and volume controls pass.
• Authorized cable and sensor function normally.
• Original settings are restored with no unresolved complaint.

Remove From Service Criteria

• Damage, liquid intrusion, contamination, corrosion, or leakage could affect operation.
• The device cannot be cleaned and dried properly.
• Any startup, LED, speaker, key, alarm-limit, brightness, alarm, silence, timeout, or volume test fails.
• SET Tester Signal IQ/pulse bar is late or absent, SpO₂ is outside 79% to 84%, or pulse rate is outside 55 to 65 bpm.
• Sensor recognition or normal operation remains unreliable.
• Original settings cannot be restored or a system-failure message remains.
• Internal repair is indicated; refer to Masimo or an authorized service department.

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

Sources Used

• Masimo Rad-5/5v technical-document page
• Masimo Rad-5/5v Operator's Manual, LAB-5724H