Physio-Control LIFEPAK 12

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Manual Reference

Manufacturer Recommendation / AEM Status

Manufacturer-Listed PM Frequency

The manufacturer-listed maintenance schedule includes:

Performance Inspection Procedure: As needed and every 12 months.
Test and Calibration Procedures: Every 12 months.
Exterior physical inspection: As needed and every 12 months.
Interior physical inspection: Every 12 months.
Exterior cleaning: As needed and every 12 months.
Interior cleaning: Every 12 months.

The factory-default maintenance-prompt interval is 12 months. The service menu permits the prompt to be set to Off, 3 months, 6 months, or 12 months. Reset the maintenance-prompt counter after scheduled maintenance is completed.

The manufacturer-listed Performance Inspection Procedure is a complete closed-case safety and performance inspection. Perform all tests applicable to the installed device configuration from start to finish in the order presented in the service manual.

Manufacturer-Listed Replacement Intervals

Battery connector pins: Every 2 years.
3-lead or 12-lead ECG cable: Every 2 years.
Coin/clock battery: Every 5 years.

The manual also gives the following approximate battery useful lives under proper maintenance:

FASTPAK: Approximately 2 years.
FASTPAK 2: Up to 5 years.
LIFEPAK SLA: Up to 3 years.

These are useful-life estimates, not unconditional replacement intervals. Remove batteries from use for physical damage, leakage, failed conditioning, unacceptable runtime, or a Battery Support System 2 DISCARD result.

Post-Repair Safety Inspection

Complete the applicable Performance Inspection Procedure after any repair, component replacement, or calibration procedure. A device that has been dropped, damaged, or abused should be inspected by a qualified technician to verify performance and acceptable leakage-current values before return to service.

AEM Note

If the facility performs this PM at a different interval or changes the manufacturer-listed activities, document the change under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

Exterior and accessory inspection.
Device self-test and service-log review.
Controls, display, printer, speaker, and alarms.
Battery and auxiliary-power operation.
ECG monitoring and leads-off detection.
Defibrillation, synchronization, AED, and impedance functions.
Noninvasive pacing, when installed.
Installed monitoring options.
Electrical safety and leakage-current testing.
Manufacturer-listed replacement items.
Maintenance-prompt reset and final documentation.

Required Tools and Equipment

Use calibrated test equipment meeting the specifications in the service manual. Equivalent equipment may be substituted when it meets the manufacturer-listed requirements.

Defibrillator analyzer compatible with the installed monophasic or biphasic waveform.
Analyzer energy range of 0–450 J.
50 Ω ±1% test load.
Analyzer accuracy of ±2% of reading plus 2 J.
NSR, VF, and sine-wave simulation.
Multiparameter patient simulator with ECG and applicable pressure simulation.
Electrical safety analyzer with patient-lead leakage capability.
QUIK-COMBO test-post adapter, Physio-Control PN 3005302.
Compatible QUIK-COMBO therapy cable, Physio-Control PN 3006570, or standard paddles as configured.
3-lead ECG cable, Physio-Control PN 3006218.
12-lead ECG cable, Physio-Control PN 805265, when applicable.
AC power adapter, Physio-Control PN 3010942, when tested with the device.
Analog ECG output cable, Physio-Control PN 3010484, when applicable.
Stopwatch.
Oscilloscope when required by the full Performance Inspection Procedure.
NIBP calibration kit and calibrated pressure/vacuum meter when NIBP is installed.
SpO₂ test sensor or simulator appropriate for the installed option.
CO₂ calibration kit, 5% CO₂ calibration gas, FilterLine, and leak-test fixture when CO₂ is installed.
Invasive-pressure simulator and cable when invasive pressure is installed.
Correct printer paper.
Two verified functional batteries.

All test equipment used for the Performance Inspection Procedure should have current calibration identification from a certified calibration facility.

Step-by-Step PM Procedure

1. Review Device Configuration and Maintenance History

Action: Identify and document:

Serial number.
Monophasic or biphasic configuration.
Installed therapy and monitoring options.
3-lead or 12-lead ECG configuration.
QUIK-COMBO cable or standard paddles.
Battery type.
AC/DC power adapter included with the asset.
Previous repairs, calibration, failures, and battery replacements.
Current maintenance-prompt setting.
Manufacturer-listed replacement items due by age.

Preserve or print the device setup configuration before making changes. Configuration restoration between devices requires matching software revisions. Verify default-energy settings when transferring configurations between different waveform versions.

Expected outcome: The test plan includes every installed option, and the clinical setup configuration is protected.

2. Remove the Device from Clinical Use

Action: Remove the LIFEPAK 12 from patient-care availability and provide an approved replacement defibrillator before beginning testing.

Confirm that no patient is connected and that defibrillation energy will be discharged only into a rated analyzer or test load.

Expected outcome: The device can be tested without interrupting emergency-response readiness or creating a shock hazard.

3. Exterior Physical Inspection

Action: Inspect the device for:

Case damage, cracks, deformation, excessive wear, or fluid intrusion.
Loose or rattling internal hardware.
Missing or damaged rubber feet.
Damage to the carrying strap, mounting points, gurney hooks, bags, or retainers.
Keypad damage, cracked overlays, lifting edges, or unreadable labels.
Display-window damage.
Printer door, latch, roller, and paper-compartment damage.
Battery-well and retention-mechanism damage.
Loose, corroded, bent, cracked, or worn battery connector pins.
Damage to therapy, ECG, SpO₂, CO₂, NIBP, invasive-pressure, power, and system connectors.
Paddle-well and paddle-retention hardware damage when equipped.
Contamination or residue around connectors and controls.

Lift and rotate the device while listening for loose hardware.

Expected outcome: No physical condition exists that could affect safe operation, cleaning, battery contact, accessory connection, or mechanical integrity.

Remove from service when: The case is cracked, fluid intrusion is suspected, battery pins are unreliable, a therapy or patient connector is damaged, loose internal hardware is heard, or a dropped or abused device has not completed the applicable Performance Inspection Procedure.

4. Inspect Accessories and Consumables

Action: Inspect all accessories assigned to the device, including:

QUIK-COMBO therapy cable.
Standard paddles and pediatric paddle adapters.
ECG cables and lead wires.
SpO₂ sensors and extension cables.
NIBP hose and cuffs.
CO₂ FilterLine accessories.
Invasive-pressure cables.
Power adapter and output cable.
Printer paper.
Disposable therapy and ECG electrodes.

Check for cracks, cuts, kinks, exposed conductors, contamination, loose connections, damaged paddle surfaces, missing controls, incorrect accessories, and expired consumables. Check ECG cable age against the manufacturer-listed 2-year replacement interval.

Expected outcome: All accessories are intact, compatible, within expiration, and suitable for clinical use.

5. Clean the Device

Action: Clean the exterior using manufacturer-approved methods and cleaning agents.

Do not immerse the device or allow liquid to enter connectors, battery wells, printer components, or case openings. Perform interior inspection and cleaning only by qualified personnel following the service-manual disassembly, high-voltage discharge, and ESD precautions.

Expected outcome: The device is visibly clean and free from material that could interfere with operation, connectors, printer movement, or cooling.

6. Install Test Accessories

Action:

Install two verified functional batteries.
Confirm each battery locks securely into its well.
Install the correct printer paper.
Connect the QUIK-COMBO therapy cable and test-post adapter, or install the standard paddles.
Connect the appropriate patient simulator and installed-option test equipment.
Connect the defibrillator analyzer using a rated 50 Ω test load.

A functional battery should not immediately generate a LOW BATTERY message when the device is powered on.

Expected outcome: The test setup is secure and appropriate for the device configuration.

7. Power-On Self-Test

Action: Turn on the device and verify:

The display illuminates.
SELF TESTS IN PROGRESS and the software revision appear during startup.
Front-panel indicators briefly illuminate.
A clear startup tone sounds.
The ON indicator remains lit.
The SERVICE indicator remains off.
No unexpected service or fault message appears.
Battery status icons appear correctly.
The home screen is complete, stable, and readable.

Record the software revision.

Expected outcome: The device completes startup without a fault, service indication, abnormal reset, or display/audio failure.

8. Record Service Data and Error History

Action: Enter Service Mode and review:

Error log and fault messages.
Power-cycle count.
Pacing count, when installed.
Shock count and shock counters by energy range.
Power-on time.
Printer operating time.
SpO₂ and CO₂ operating time.
NIBP inflation cycles.
Defibrillator capacitor value when displayed.

Do not clear error logs or counters unless permitted by facility policy and adequately documented. Investigate active, recurring, or unexplained service errors before continuing.

Expected outcome: No unresolved service code or operating-history condition indicates an unsafe or unreliable device.

9. Controls, Selector, Indicators, and Display

Action: Use the Service Mode button test to:

Operate each front-panel key.
Verify the associated button-test field responds.
Rotate and press the selector.
Verify all installed-option controls.
Test display pixels and contrast.
Check for missing pixels, unstable illumination, unreadable areas, or intermittent operation.
Confirm control and status indicators illuminate correctly.

Expected outcome: Every installed control responds correctly, and the display is complete and readable.

10. Printer Test

Action: Run the Service Mode printer test and verify:

The large X pattern prints without missing dots.
Seven horizontal lines are present.
Characters are complete and readable.
Vertical reference lines are spaced 25 mm ±5% apart.
Paper feeds smoothly.
Opening the printer door produces the CHECK PRINTER message.
Closing the door clears the condition.

Expected outcome: The printer produces a complete, properly scaled, legible test strip without missing dots or feed problems.

11. Speaker, Voice Prompt, and Alarm Test

Action: Run the Service Mode voice/tone test and verify:

Voice prompts are clear.
Alarm and advisory tones are audible.
No distortion, intermittent audio, or abnormal volume is present.
Visual alarm indications operate with audible alarms.

A full playback of every voice prompt is not necessary after clear, undistorted operation has been established unless facility policy requires it.

Expected outcome: Audio and visual notification functions are clearly recognizable and reliable.

12. Battery and Power-Source Management

Action: With both batteries installed and the device operating:

Confirm both battery icons appear.
Remove Battery 1 and verify continued operation from Battery 2.
Reinstall Battery 1.
Remove Battery 2 and verify continued operation from Battery 1.
Reinstall Battery 2.
Connect the AC power adapter.
Verify transfer to auxiliary power and appropriate battery-charge indications.
Disconnect auxiliary power and verify uninterrupted transfer to battery power.

For the manufacturer-listed auxiliary-power charge test, remove both batteries, power the unit from the AC adapter, select 360 J, initiate charging, and verify the charge cycle is 10 seconds or less.

Expected outcome: The device transfers between batteries and auxiliary power without shutdown or abnormal indication and charges to 360 J on auxiliary power within the manufacturer-listed time.

13. ECG Monitoring and Leads-Off Detection

Action: Perform the applicable 3-lead or 12-lead Performance Inspection Procedure tests.

For a 3-lead device:

Simulate 60 BPM normal sinus rhythm.
Verify the correct heart rate and waveform.
Disconnect LL, RA, and LA individually.
Verify the applicable leads-off message.

For a 12-lead device:

Connect all ten leads.
Verify normal ECG display.
Disconnect applicable limb and precordial leads individually.
Verify leads-off detection during monitoring and 12-lead acquisition.

For ECG gain verification with a 1 mV, 10 Hz sine wave and ECG size 4.0:

Lead I printed amplitude: 18–22 mm peak-to-peak.
Lead II printed amplitude: 36–44 mm peak-to-peak.
V1–V6 printed amplitude when applicable: 36–44 mm peak-to-peak.

Expected outcome: ECG rate, waveform, lead selection, leads-off detection, acquisition, and printed gain meet the applicable manufacturer criteria.

14. Therapy-Cable or Paddle Impedance Detection

Action: Perform the applicable QUIK-COMBO impedance-sense or standard-paddle connection tests from the Performance Inspection Procedure.

Verify the device identifies the connected therapy accessory.
Verify connected and disconnected electrode conditions are correctly recognized.
Verify appropriate connect-electrodes messages and alarms occur.
Confirm the therapy connector and cable remain stable during gentle manipulation.

Expected outcome: The device correctly recognizes the therapy accessory and detects an open or disconnected patient circuit.

15. Manual Defibrillation Performance

Action: Using the defibrillator analyzer:

Verify energy selection.
Charge and discharge only into the analyzer or rated test load.
Test all energy levels specified by the applicable Performance Inspection Procedure.
Record selected and delivered energy.
Verify charge time.
Verify the charge-ready tone and indicator.
Verify energy is delivered only when commanded.
Verify stored energy is safely dumped during cancellation, mode change, or other applicable conditions.
Test QUIK-COMBO and standard paddles when both are assigned to the asset.

Use the exact delivered-energy tolerances listed in the applicable monophasic or biphasic Performance Inspection Procedure. Do not apply one waveform configuration’s limits to another.

Expected outcome: Delivered energy and charge time meet the configuration-specific manufacturer limits, with no unintended discharge or failure to dump stored energy.

16. Synchronized Cardioversion

Action: Apply a simulated ECG signal and enable SYNC.

Verify the SYNC indicator illuminates.
Verify synchronization markers align with the simulated QRS complexes.
Verify the device does not deliver an unsynchronized shock while SYNC is active.
Verify the shock occurs in synchronization with the detected QRS as specified by the Performance Inspection Procedure.
Verify SYNC terminates or remains active according to the configured operation.

Expected outcome: The device recognizes QRS complexes and delivers synchronized energy correctly.

17. AED and Shock Advisory Operation

Action: Enter Advisory/AED mode and apply the analyzer rhythms required by the Performance Inspection Procedure.

Verify a shockable rhythm produces the expected analysis result and prompts.
Verify a nonshockable rhythm does not produce an inappropriate shock recommendation.
Verify analysis, charging, voice prompts, indicators, and shock controls operate correctly.
Verify electrode-disconnect and motion conditions are recognized when tested.

Expected outcome: The Shock Advisory System responds correctly to simulated rhythms and does not recommend or enable therapy inappropriately.

18. Noninvasive Pacing — When Installed

Action: Using the defibrillator analyzer:

Verify pacing activates.
Disconnect a therapy test-post connection.
Verify PACING/CONNECT ELECTRODES appears.
Verify an audible alarm sounds.
Reconnect the test post and verify the message and alarm clear.
Verify pacing rate and current at the test points specified in the Performance Inspection Procedure.
Verify demand and nondemand operation where applicable.
Verify pacing pulse width at 200 mA is 19.0–21.0 ms.

For devices without the pacing option, perform the manufacturer-listed no-pacer characteristic or self-calibration check.

Expected outcome: Pacing rate, output current, pulse width, leads-off detection, and operating mode meet the applicable manufacturer criteria.

19. ECG Analog Output — When Used

Action: Connect the manufacturer-listed analog ECG output cable to the system connector and verify the output waveform using the applicable Performance Inspection Procedure setup.

Expected outcome: The analog ECG output is present, correctly scaled, and free from abnormal distortion.

20. SpO₂ Verification — When Installed

Action: Using the applicable sensor or simulator:

Verify sensor detection.
Verify pulse indication and displayed saturation.
Verify disconnect and alarm response.
Complete the SpO₂ leakage-current tests in the Performance Inspection Procedure.

Expected outcome: The SpO₂ option detects the sensor, displays the test value, responds to disconnection, and meets applicable electrical-safety limits.

21. NIBP Verification — When Installed

Action: Using a calibrated pressure simulator or pressure/vacuum meter:

Verify displayed pressure accuracy at the manufacturer-listed test points.
Verify the cuff and hose connection.
Perform the NIBP leakage test.
Confirm the device reports LEAKAGE TEST OK.
Verify overpressure protection and deflation according to the full Performance Inspection Procedure.

Expected outcome: NIBP pressure measurement, leakage, deflation, and safety protection meet the manufacturer criteria.

22. EtCO₂ Verification — When Installed

Action: Using the manufacturer-listed calibration equipment and 5% CO₂ calibration gas:

Inspect the intake connector and exhaust port.
Perform the pump, leakage, zero, and calibration-gas checks in the applicable procedure.
Verify displayed CO₂ and respiration operation.
Confirm no blockage, leak, or calibration failure is present.

Expected outcome: The CO₂ option passes leak and calibration verification and correctly displays the applied test gas.

23. Invasive-Pressure Verification — When Installed

Action: Connect the invasive-pressure simulator and verify:

Both installed channels are detected.
The zero function operates.
Applied pressures display within the manufacturer-listed tolerance.
Disconnect conditions and alarms operate correctly.

Expected outcome: Each installed invasive-pressure channel zeros, measures, and alarms correctly.

24. Complete Annual Calibration Procedures

Action: At the manufacturer-listed 12-month interval, complete all applicable Test and Calibration Procedures for the installed configuration, including:

Defibrillation calibration.
Pacing calibration.
Printer calibration.
NIBP calibration.
CO₂ calibration.
Invasive-pressure calibration.

Do not adjust a subsystem solely because a test value appears unusual unless the applicable Performance Inspection Procedure or Test and Calibration Procedure indicates an out-of-tolerance result.

Expected outcome: Every installed subsystem completes the applicable calibration procedure without an error or out-of-tolerance condition.

25. Check Manufacturer-Listed Replacement Items

Action: Verify replacement dates and replace items when due:

Battery connector pins: Every 2 years.
3-lead or 12-lead ECG cable: Every 2 years.
Coin/clock battery: Every 5 years.

Evaluate each rechargeable battery through the appropriate Battery Support System maintenance process. Remove batteries with case damage, leakage, failed conditioning, failed shelf-life testing, a BSS 2 DISCARD indication, unacceptable clinical runtime, or unreliable connection or status indication.

Expected outcome: Definite-life components are within the manufacturer-listed interval, and batteries remain serviceable.

26. Reset Maintenance Prompt and Restore Configuration

Action: After all maintenance and testing pass:

Restore the original clinical setup and Manual Access setting.
Verify the date and time.
Enter Service Mode.
Select MAINT PROMPT.
Confirm the approved interval.
Select RESET.
Verify the next-prompt date advances correctly.
Power-cycle the device and confirm no unexpected MAINTENANCE DUE or SERVICE message remains.

Expected outcome: The approved configuration is restored, the next maintenance date is correct, and no unresolved service condition remains.

27. Final Operational Check

Action: Perform a final user-level check with the device fully assembled:

Power-on self-test.
Battery and AC operation.
ECG waveform and heart rate.
Audible and visual alarms.
Printer operation.
Therapy-accessory recognition.
Charge and controlled test discharge.
Pacing when installed.
Installed parameter options.
Date, time, and clinical setup.
Accessory inventory and electrode expiration.

Expected outcome: The complete device and assigned accessories are ready for clinical service.

Electrical Safety Testing

The manufacturer Performance Inspection Procedure includes configuration-specific leakage-current testing for the LIFEPAK 12, patient connections, therapy connections, installed options, and AC power adapter. Follow the exact manufacturer test setup and electrical conditions rather than substituting one generic leakage measurement.

Ground Resistance

A specific general device ground-resistance limit was not identified in the provided LIFEPAK 12 service-manual PM schedule. When the AC power adapter or facility electrical-safety program requires a protective-earth measurement, document the facility criterion separately.

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

Result =

The ≤ 0.5 Ω field is a facility/NFPA 99 documentation convention, not a LIFEPAK 12 manufacturer-listed limit in the reviewed manual.

Touch/Chassis Leakage

Touch/chassis leakage measured in microamps:

Facility limit used =

Result =

Pass / Fail =

Manufacturer-Listed Leakage Tests

Complete every applicable Performance Inspection Procedure leakage test, including:

Earth leakage current.
Therapy, paddles, or QUIK-COMBO source leakage.
ECG source and sink leakage.
Installed-option source and sink leakage.
AC power-adapter leakage tests.

Manufacturer-listed examples include:

Paddles or QUIK-COMBO source leakage, normal ground: Less than 10 µA.
Paddles or QUIK-COMBO source leakage, lifted ground: Less than 50 µA.
SpO₂ sink leakage at 120 VAC: Less than 100 µA.
SpO₂ sink leakage at 240 VAC: Less than 500 µA.
Earth leakage at the cited Performance Inspection Procedure condition: Less than 5000 µA.

These limits apply only to their exact manufacturer test setups and electrical conditions. They are not interchangeable with generic chassis-leakage limits.

Document each applicable measurement:

Test configuration =

Manufacturer limit =

Measured result =