Physio-Control LIFEPAK 15

Asset Type

Defibrillator

Manufacturer

Physio-Control

Model

LIFEPAK 15

Manual Reference

LIFEPAK 15 Monitor/Defibrillator Service Manual, MIN 3309059-000

Manufacturer Recommendation / AEM Status

Manufacturer-listed PM items

The service manual lists preventive maintenance around the following items:

• Daily device self-test / auto test
• Device user test
• Performance Inspection Procedures
• Test and Calibration Procedures when needed
• Exterior physical inspection
• External cleaning
• Scheduled replacement items
• Battery maintenance
• Leakage current testing
• Maintenance prompt reset after scheduled maintenance

Manufacturer-listed frequencies

Manufacturer-listed maintenance schedule:

• Performance Inspection Procedures: 12 months and as needed
• Test and Calibration Procedures: as needed
• Exterior physical inspection: daily and 12 months
• External cleaning procedure: 12 months and as needed

Manufacturer-listed scheduled replacement items

• ECG cable: 2 years
• Lithium-ion battery pak: 2 years
• Coin / clock battery: 5 years
• Disposable electrodes: replace by “Use by” date

Manufacturer-listed part numbers and notes

• LIFEPAK 15 Li-ion battery: PN 3206735
• Coin battery replacement note: contact a Physio-Control service representative for assistance when coin battery replacement is required.

Post-repair requirement

The manual lists the Performance Inspection Procedures as part of scheduled PM and after repair, replacement, upgrade, or test/calibration procedure.

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
• Battery and accessory condition check
• User test / self-test review
• Functional performance inspection
• Defibrillator and pacing checks
• ECG, printer, audio, keypad, and configured parameter checks
• Leakage current testing
• Scheduled replacement review
• Maintenance prompt reset
• CMMS documentation

Required Tools and Equipment

Use the manual-listed Performance Inspection Procedure equipment or equivalent equipment that meets the listed specifications. The manual specifically says equivalent equipment may be substituted, but test equipment must have current calibration.

Common listed equipment includes:

• Defibrillator analyzer with external noninvasive pacer measurements
• Patient simulator
• Electrical safety analyzer
• ESA612 adapter box or equivalent ECG snap connection adapter
• Decade resistance box
• Digital pressure meter
• Stopwatch
• QUIK-COMBO therapy cable
• FAST-PATCH cable assembly or equivalent adapter
• Electrode test posts
• ECG cables: 3-lead, 5-wire, and/or 12-lead as applicable
• SpO2 sensor, if equipped
• LIFEPAK 15 Li-ion battery pak, less than 2 years old
• NIBP calibration kit and hose, if equipped
• CO2 leak/calibration tubing, calibration gas, and FilterLine set, if equipped
• Temperature probe simulator and adapter cable, if equipped
• Hard paddle leakage adapter / QC leakage cable, if hard paddles are tested
• Battery leakage test adapters
• AC/DC power adapter and external power extension cable, if applicable

Step-by-Step PM Procedure

1. Confirm Device Status and Configuration

Action: Confirm the unit is a LIFEPAK 15 and identify installed options such as SpO2, CO2, NIBP, invasive pressure, temperature, 12-lead ECG, Bluetooth, auxiliary power, hard paddles, and QUIK-COMBO therapy cable.

Expected outcome: PM testing matches the actual device configuration.

Why it matters: The manual states all required Performance Inspection Procedure tests applicable to the device configuration under test must be performed.

2. Remove From Clinical Use

Action: Remove the defibrillator from service for PM. Confirm no patient data or active clinical need is present before testing.

Expected outcome: Device is available for safe bench testing.

3. Exterior Physical Inspection

Action: Inspect the exterior case, handle, display, keypad, printer door, connectors, battery wells, battery contacts, therapy connector, ECG connector, SpO2 connector, CO2 port, NIBP port, IP/temp ports, system connector, auxiliary connector, paddle wells, paddle retainers, and paddle test contacts as applicable.

Expected outcome: No cracks, loose parts, damaged pins, fluid intrusion, contamination, missing labels, connector damage, or accessory damage.

Remove from service if physical damage could affect operation, therapy delivery, monitoring accuracy, charging, or electrical safety.

4. Check Batteries and Battery Age

Action: Inspect both LIFEPAK 15 Li-ion battery packs. Confirm battery age and condition. Check fuel gauge. Verify batteries are Physio-Control LIFEPAK 15 batteries.

Expected outcome:

• Batteries are not physically damaged.
• Batteries do not show charger fault condition.
• Batteries are within facility replacement interval.
• Battery pak replacement interval reviewed: 2 years.
• Battery PN 3206735 if using the manual-listed battery.

Remove from service or replace battery if:

• Battery case is physically damaged.
• Charger shows solid red fault LED during charge.
• Battery fuel gauge shows two or fewer green LED bars after full charge.
• Battery is past facility/manufacturer-listed replacement interval.

5. Review Disposable Electrodes and Accessories

Action: Check QUIK-COMBO electrodes, ECG electrodes, cables, paddles, therapy cable, ECG cable, SpO2 cable/sensor, NIBP hose/cuff, CO2 FilterLine, and other accessories.

Expected outcome:

• Disposable electrodes are within “Use by” date.
• Cables are intact with no cuts, exposed conductors, bent pins, or loose connectors.
• ECG cable replacement interval reviewed: 2 years.
• Accessories match approved device configuration.

Remove from service if accessories are expired, damaged, incompatible, or fail testing.

6. Perform Device User Test / Self-Test Review

Action: Run the LIFEPAK 15 User Test from Options/User Test.

Expected outcome:

• Device performs self-test.
• Defibrillation capacitor charges to 10 joules and dumps internally.
• Test result is stored and printed.
• User Test passes.
• Service LED does not illuminate.

Remove from service if User Test fails, Service LED illuminates, or an error is written to the Service Log.

7. Verify Date and Time

Action: Confirm date and time are correct.

Expected outcome: Date/time is accurate per facility policy.

Why it matters: Event records, test reports, and CODE SUMMARY documentation depend on correct time.

8. Perform Performance Inspection Procedures

Action: Perform the applicable Performance Inspection Procedure sections for the configured device.

Include applicable checks for:

• Power management
• User Test and date/time verification
• Temperature calibration check, if equipped
• CO2 tests, if equipped
• NIBP tests, if equipped
• Printer tests
• Keypad tests
• Audio test
• Invasive pressure verification, if equipped
• SpO2/SpCO/SpMet test, if equipped
• ECG performance testing
• Defibrillator/pacing testing
• QUIK-COMBO ECG characteristic tests
• Standard paddles user test, if equipped
• Standard paddles delivered energy tests, if equipped
• Patient impedance test
• Data management checks, if applicable
• Leakage current tests

Expected outcome: All applicable Performance Inspection Procedure tests pass within manual-listed limits.

Remove from service if any test fails or is out of tolerance.

9. Perform Test and Calibration Procedures Only When Needed

Action: Perform Test and Calibration Procedures only when required by the manual, after applicable repairs/replacements, or when Performance Inspection Procedure results indicate calibration or adjustment is needed.

Expected outcome: Device passes applicable calibration or verification procedure.

Do not treat Test and Calibration Procedures as a blanket annual calibration unless facility policy requires it or a manual-supported condition triggers it.

10. Printer Maintenance

Action: Inspect printer paper path and print quality. Clean printer components when needed.

Manual-listed printer maintenance:

• Clean print roller with alcohol-soaked cotton swab to remove paper debris or residue.
• Clean printhead after approximately 100 rolls of chart paper, or more often if needed.
• Clean paper sensor whenever the printhead is cleaned.

Expected outcome: Printer feeds correctly, door closes properly, print is readable, and paper sensor is not blocked by debris.

11. Cleaning

Action: Clean exterior surfaces as needed and during scheduled PM per facility infection control policy.

Manual-listed cleaning solutions include:

• Soap and water
• Quaternary ammonium compounds
• Isopropyl alcohol
• Peroxide / peracetic acid solutions

Manual cautions:

• Do not immerse or soak any portion of the device.
• Avoid spilling fluid on the device or accessories.
• Do not clean with bleach, bleach dilution, phenolic compounds, abrasive cleaners, or flammable cleaners.
• Do not sterilize unless specified in accessory instructions.

Expected outcome: Device is clean, dry, and free of residue or contamination.

12. Reset Maintenance Prompt

Action: After scheduled PM is completed, reset the maintenance prompt interval if the facility uses the MAINTENANCE DUE prompt.

Manual-listed options:

• 3 months
• 6 months
• 12 months
• Factory default: OFF

Expected outcome: MAINTENANCE DUE message is cleared and next prompt date is updated.

Electrical Safety Testing

The manual includes leakage current testing and states leakage current testing should be performed according to IEC 62353 for recurrent test / test after repair, or IEC 60601-1 and IEC 60601-2-4.

Ground resistance

The provided manual section focuses on leakage current testing and does not provide a simple ground resistance PM limit in the extracted PM section.

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

Leakage current

Use the manual-listed leakage test setup and limits based on the selected standard, power condition, and applied part type.

Manual-listed IEC 62353 limits include:

• Direct equipment leakage current: 300 μA max at 120 V / 60 Hz; 500 μA max at 240 V / 50 Hz
• Direct applied parts leakage current, CF type ECG / pace / ECG / temp / IP / internal paddles: 50 μA max
• Direct applied parts leakage current, BF type SpO2 / CO2 / NIBP / external paddles / QUIK-COMBO cable: 5000 μA max

Manual-listed IEC 60601-1 limits include several normal condition and single fault condition limits. Use the facility-selected standard and document the limit used.

Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =

Applied part leakage measured in microamps:
Applied part tested =
Standard used = IEC 62353 / IEC 60601-1 / facility policy
Facility/manual limit used =
Result =
Pass / Fail =

Pass / Fail Criteria

Pass PM if:

• Exterior inspection passes.
• Batteries and accessories are acceptable.
• Disposable electrodes are not expired.
• User Test passes.
• Service LED is not illuminated.
• Applicable Performance Inspection Procedure tests pass.
• Leakage current testing passes using the selected manual/facility standard.
• Printer, keypad, audio, ECG, therapy, pacing, and configured parameters pass applicable checks.
• Maintenance prompt is reset if used.
• Work order includes measured values and final status.

Remove from service if:

• User Test fails.
• Service LED illuminates.
• Any applicable Performance Inspection Procedure item fails.
• Defibrillator energy, pacing, ECG, leakage, NIBP, CO2, temperature, SpO2, printer, keypad, or audio test fails.
• Battery is damaged, faulted, or fails post-charge fuel gauge criteria.
• Battery, cable, or electrode replacement is overdue per manufacturer-listed interval or facility policy.
• Disposable electrodes are expired.
• Any physical damage could affect safe operation or therapy delivery.
• Leakage current exceeds the selected manual/facility limit.

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