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Manual Reference
LIFEPAK 35 Performance Inspection Procedure (PIP), Document 3340124-000 Rev AH; LIFEPAK 35 PIP Checklist, Document 3340124-002 Rev AH; and the current configuration-specific Service Manual/TCP.
Manufacturer Recommendation / AEM Status
Stryker identifies this as an annual and post-repair performance inspection. Perform the complete closed-case PIP after repair, replacement, or calibration and before return to service. The PIP is intended for qualified biomedical/electronics service personnel, must be completed from start to finish in the published order, and requires calibrated test equipment plus the current PSST and WCT software where applicable.
Apply stricter regulatory or facility requirements when required; any alternative interval belongs under the facility's approved AEM program.
What This PM Procedure Covers
- Identity, configuration, service history, exterior, batteries, power-up, controls, display, and accessories
- Auxiliary-power and battery-source switching, printer/modem options, Auto Test, date/time, and USB ports
- Patient impedance, delivered energy, 360 J charge time, synchronized cardioversion, pacing, and therapy ECG
- Diagnostic ECG leads plus installed SpO2, SpCO, SpMet, temperature, invasive-pressure, CO2, and NIBP functions
- Optional operating-data, Bluetooth, and Wi-Fi checks
- AC-powered direct equipment and applied-part leakage testing and final maintenance-prompt reset
Required Tools and Equipment
- Current Stryker LIFEPAK 35 PIP, checklist, Service Manual/TCP, PSST, and WCT as applicable
- Calibrated defibrillator analyzer rated for 0-450 J with a 50 ohm load and ECG/pacer/synchronization functions
- Calibrated electrical safety analyzer suitable for 120/240 VAC and direct equipment/applied-part leakage
- Calibrated decade resistance box, 0-9 megohms, 1-ohm resolution, 1% accuracy
- Calibrated digital pressure meter, NIBP service hose/kit, and applicable pressure adapters
- ECG, therapy, printer, SpO2 leakage, temperature, invasive-pressure, CO2 leak/calibration, and configuration-specific test cables
- Approved CO2 calibration gas, physiological simulators, USB drive, PC with current service software, and optional modem/network test resources
- Two fully functional LIFEPAK 35 batteries and manufacturer-approved cleaning supplies
Step-by-Step PM Procedure
1. Verify Identity, Configuration, and Inspection Type
Action: Record the asset tag, serial number, model, software versions, installed options, accessories, department, and whether the inspection is annual or post-repair. Use the current PIP/checklist revision for the exact configuration.
Expected outcome: The unit matches CMMS, the inspection type is identified, and every applicable test is known.
2. Review History and Maintain Clinical Coverage
Action: Provide suitable replacement emergency equipment before removing the unit. Review service history, reported problems, shocks/pacing use, prior test results, repairs, calibration, battery history, event logs, and open corrective actions.
Expected outcome: Emergency coverage remains available and known faults or post-repair requirements are identified.
3. Verify Personnel, Software, and Test Equipment
Action: Confirm the technician is qualified, each measuring device has current calibration, and the latest applicable PSST/WCT and OEM cables/adapters are available. Follow the PIP from start to finish and observe high-energy precautions up to 360 J.
Expected outcome: The inspection is properly controlled and all test equipment is suitable and in calibration.
4. Inspect and Clean the Exterior
Action: Inspect for loose or rattling hardware. Check the front display, keypad, bezel and USB cover; right-side case, ECG port/cable and both battery wells; top case, handle, therapy connector and release; bottom skid plate; parameter-module case, CO2/USB covers, labels and accessories. Clean only by the current operator/service instructions.
Expected outcome: The enclosure, controls, ports, connectors, covers, labels and accessories are secure, clean and undamaged, with no loose internal hardware.
5. Install Batteries and Perform Power-On/Self-Test
Action: Install two fully functional LIFEPAK 35 batteries, power on, observe startup and the self-test, and check the display, indicators, speaker and controls for errors.
Expected outcome: The device starts normally, completes self-test, recognizes both batteries and shows no unresolved service indication.
6. Verify Auxiliary Power and Power-Source Management
Action: Connect approved auxiliary AC power and confirm the green auxiliary-power indicator. Verify neither battery icon is highlighted while on AC, then remove AC and verify one battery becomes the active highlighted source. Perform the PIP battery/power-source switching sequence.
Expected outcome: AC indication and automatic switching between auxiliary power and batteries operate correctly without interruption or error.
7. Verify Optional Modem, Printer, and SHIFT Functions
Action: If installed, confirm modem and printer recognition. Perform the SHIFT check and the optional printer SHIFT check exactly as directed by the PIP. Mark only genuinely absent options N/A.
Expected outcome: Installed options are recognized and SHIFT/printing functions pass, or absent options are correctly documented N/A.
8. Run Auto Test and Verify Date, Time, and USB Ports
Action: Run Auto Test, verify the date/time, and test enumeration on every USB port using the approved USB device and PIP workflow.
Expected outcome: Auto Test passes, date/time are correct, and every USB port recognizes the test device.
9. Verify Patient-Impedance Detection
Action: Using the prescribed therapy cable and decade box/analyzer, verify 349 ohms produces PADDLES LEADS OFF, 50 ohms produces no lead-off message, 254 ohms produces no lead-off message, and the open condition produces PADDLES LEADS OFF. Do not deliver energy into an unsuitable resistance box.
Expected outcome: Each impedance state is identified exactly as specified.
10. Verify Delivered Energy
Action: Deliver the PIP-prescribed shocks into the calibrated 50-ohm analyzer. Verify 10 J = 9.1-10.9 J, 50 J = 46.6-53.4 J, 200 J = 186.0-214.0 J, and 360 J = 334.8-385.2 J. When verifying immediately after TCP energy calibration, use the tighter limits: 50 J = 47.5-52.5 J, 200 J = 195-205 J, and 360 J = 351-369 J.
Expected outcome: Every required energy measurement is within the limit applicable to the inspection state.
11. Verify Charge Time and Synchronized Shock Delay
Action: Measure the 360 J charge time and verify it is less than 10 seconds. Perform the synchronized-cardioversion timing test and verify shock delay is no more than 60 ms.
Expected outcome: Charge time is under 10 seconds and synchronized delay is 60 ms or less.
12. Verify Pacing
Action: Confirm the prescribed pacing leads-off response. With the calibrated analyzer, verify 10 mA setting = 5-15 mA, 100 mA = 90-110 mA, and 200 mA = 180-220 mA; verify pulse width = 19.2-20.8 ms.
Expected outcome: Pacing detection, output current and pulse width meet all limits.
13. Verify Therapy ECG
Action: Apply the prescribed analyzer ECG through the therapy connection. Confirm a positive R wave and verify paddle-lead gain at 1 mV is 38-42 mm.
Expected outcome: Therapy ECG polarity and displayed gain pass.
14. Verify Diagnostic ECG Leads
Action: Perform leads-off checks and then verify gain with the cables installed: Lead II 38-42 mm; Lead I 26-30 mm; Lead III 11-13 mm for 3-wire; V1/C 36-44 mm for 13/10/5-wire; V2-V6 36-44 mm for 13/10-wire; and V7/A1, V8/A2 and V9/A3 36-44 mm for 13-wire.
Expected outcome: Leads-off detection and every applicable lead amplitude meet the checklist limits.
15. Verify SpO2, SpCO, and SpMet
Action: Test installed oximetry functions with the prescribed simulator. Verify SpO2 reads 50-100%; if installed, SpCO reads 0-40% and SpMet reads 0-15%.
Expected outcome: Each installed oximetry parameter reports within its specified test range.
16. Verify Temperature and Invasive Pressure
Action: For installed T1/T2/T3 channels, verify a 25 C input reads 24.8-25.2 C and a 45 C input reads 44.8-45.2 C. Zero each installed P1/P2/P3 channel and verify -30 mmHg reads -34 to -26, 20 reads 16-24, 100 reads 96-104, and 300 reads 288-312 mmHg.
Expected outcome: Each installed temperature and invasive-pressure channel zeros and meets all applicable limits.
17. Verify CO2
Action: With the approved leak and calibration equipment, verify the leakage-test pressure change is less than 15 mmHg and a 5.0% calibration-gas input reads within plus or minus 0.82%.
Expected outcome: The installed CO2 module passes leakage and calibration checks.
18. Verify NIBP and Optional Operating Data
Action: Run the NIBP leakage check and confirm the command completes. Verify 50 and 150 mmHg readings are within plus or minus 3 mmHg and overpressure relief occurs at 270-296 mmHg. If applicable, retrieve and document operating data such as shock and pacing counts.
Expected outcome: NIBP leakage, accuracy and overpressure protection pass, and applicable usage data are recorded.
19. Verify Optional Wireless Functions
Action: If configured, complete Bluetooth pairing and verify Wi-Fi connection using the approved network/test workflow. Restore the customer's communication configuration after testing.
Expected outcome: Installed wireless functions connect successfully and original settings are restored.
20. Perform Electrical Safety, Reset Maintenance, and Restore Service
Action: On 120/240 VAC auxiliary power, use the exact PIP connections and verify direct equipment leakage with normal condition/reversed mains and open earth is 15-490 microamps; ECG direct applied-part leakage is 5-50 microamps; therapy direct applied-part leakage is 5-5000 microamps; and SpO2 direct applied-part leakage is 5-5000 microamps. Apply only the tests for installed parts. Disable or reset the maintenance prompt as directed, disconnect test equipment, restore the original configuration and accessories, perform the final operational/readiness check, and document all results.
Expected outcome: All applicable leakage values pass, the maintenance indication is correctly cleared, configuration is restored, and the unit is ready for service with no unresolved fault.
Electrical Safety Testing
The current LIFEPAK 35 PIP uses AC-powered direct equipment and direct applied-part leakage tests. Under the checklist conditions, direct equipment leakage is 15-490 microamps; ECG is 5-50 microamps; therapy is 5-5000 microamps; and SpO2 is 5-5000 microamps. Follow the exact analyzer connections, mains polarity and open-earth state in the current PIP. Do not substitute a generic limit or add a protective-earth-resistance criterion unless the current configuration-specific OEM procedure explicitly requires it.
Pass / Fail Criteria
Pass
- Exterior, installed accessories, batteries, power-up, self-test, controls, date/time, Auto Test and every USB port pass
- Auxiliary-power and battery-source switching pass; installed printer/modem functions pass
- Impedance messages match all four prescribed states
- Energy, charge time, synchronized delay, pacing, therapy ECG and diagnostic ECG meet the stated limits
- Every installed physiological parameter meets its leakage, accuracy, calibration or overpressure limit
- Installed wireless functions pass or absent options are correctly documented N/A
- Direct equipment and installed applied-part leakage meet the current PIP limits
- Original configuration is restored, maintenance prompt is handled, and final readiness passes
Remove From Service
- Physical damage, loose hardware, contamination, battery/power fault, failed self-test or unresolved service indication is present
- Any impedance, energy, charge-time, synchronization, pacing, ECG or physiological-parameter result is outside limits
- Any applicable leakage value is outside limits or safe test completion is not possible
- Required repair/calibration remains incomplete, configuration cannot be restored, or the complete post-repair PIP does not pass
Copy/Paste CMMS Work Order Procedure
Follow the complete current Stryker PIP in its published order. This field guide does not replace the OEM procedure, required training, service software, test fixtures, or post-repair calibration.