On this page
Asset Type
Manufacturer
Model
Configurations Covered
LIFEPAK 20 and LIFEPAK 20e with QUIK-COMBO therapy cable or standard paddles; pacing, SpO₂, CodeManagement Module (CMM), wireless, and EtCO₂ only when installed.
Manual References
LIFEPAK 20e PIP 3201896-000_C, PIP Checklist 3201896-002_C, TCP 3201896-001_C, Service Manual 3314176, applicable operating instructions, and separate CMM PIP/TCP documents when fitted.
Manufacturer Recommendation / AEM Status
Stryker's LIFEPAK 20e PIP requires the complete PIP during regularly scheduled preventive maintenance and after repair, replacement, or calibration. Its checklist identifies the PIP as annual or post-repair. Perform it from start to finish in published order with calibrated equipment.
Numerical criteria below come from LIFEPAK 20e PIP 3201896-000_C. Confirm the exact manual before applying them to an original LIFEPAK 20. Test only fitted options. Interval changes require an approved AEM program.
What This PM Procedure Covers
- Identity, configuration, physical condition, accessories, and cleaning
- Power-on, self-test, User Test, controls, display, audio, and printer
- Three-/five-lead ECG, leads-off detection, gain, and optional analog output
- QUIK-COMBO/paddle synchronization, energy, charge time, and ECG characteristics
- Pacing, impedance, batteries, power, and electrical safety
- SpO₂ and CMM/EtCO₂/wireless only when fitted
Required Tools and Equipment
- Current Stryker PIP, checklist, TCP, service/operating manuals, and CMM procedure as applicable
- Biphasic-compatible 0-450 J defibrillator analyzer with 50 Ω ±1% noninductive load and pacer capability
- ECG simulator/analyzer with required 12-lead, rate, amplitude, and 10 Hz/1 mV capabilities
- IEC 62353/IEC 60601 safety analyzer and required applied-part adapters
- Stopwatch, measuring scale, resistance box, remote-sync generator, specified cables/adapters, paper, cleaning materials, and PPE
- Current certified calibration labels on all measuring equipment
Step-by-Step PM Procedure
1. Verify Identity, Configuration, and Documentation
Action: Record asset, tag, model, serial, part number, software, department, rating, and options. Identify 20/20e, QUIK-COMBO/paddles, ECG cables, pacing, SpO₂, CMM, wireless, and EtCO₂. Select current matching documents.
Expected outcome: CMMS identity and required base/option procedures are confirmed.
2. Review History and Remove From Use
Action: Review service events, readiness/User Test failures, indicators, battery/charge, therapy/pacing, cable/printer faults, liquid intrusion, drops, and repairs. Remove from clinical service.
Expected outcome: Known risks are identified and patient use is prevented.
3. Inspect and Clean the Exterior
Action: Disconnect power. Inspect case, display, AED door, keypads, Speed Dial, printer, feet, strap/mounts, labels, inlet, ground stud, and fitted connectors. Turn over and listen for loose hardware. Clean only as directed.
Expected outcome: Exterior is clean and intact without cracks, fluid ingress, loose parts, missing feet, or damaged labels/connectors.
4. Inspect Cables, Paddles, and Accessories
Action: Inspect ECG/therapy cables, test plug, paddles/contacts, SpO₂/CO₂ items, cord, and accessories for damage, corrosion, contamination, bent pins, strain-relief failure, and expiration. Clean paddle contacts as directed.
Expected outcome: Accessories are approved, compatible, in date, clean, and intact.
5. Prepare and Preserve Settings
Action: Connect grounded AC and approved 50 mm paper. Record customer settings before service-mode changes. Follow the PIP for Manual access; restrict service access to qualified personnel.
Expected outcome: Setup is safe and original configuration is recorded.
6. Verify Power-On and Self-Test
Action: Power on and observe the nominal five-second self-test. Verify expected speaker/AC-loss tones, momentary lamps, completed sequence, AC mains indicator on, and service indicator off.
Expected outcome: Startup and indicators pass.
7. Run User Test and Verify Date/Time
Action: Connect the proper QUIK-COMBO cable/test plug and run USER TEST. Confirm a passing printout and correct date/time; correct and document as needed.
Expected outcome: User Test passes with accurate date/time.
8. Verify Controls, Display, and Audio
Action: Run Buttons, including the specified hidden switch; confirm TEST COMPLETE and service LED off. Run all Pixel screens and Voice/Tone.
Expected outcome: Every control, display region, prompt, and tone passes.
9. Verify the Printer
Action: Run the 25 mm/s test. Confirm complete X, lines, and characters; vertical lines must be 25 mm ±1 mm apart. Verify CHECK PRINTER with door open and paper removed.
Expected outcome: Print quality, spacing, and detection pass.
10. Test SpO₂ When Installed
Action: Connect the approved sensor/cable and follow the PIP. It includes a reading from 50%-100%, CHECK SENSOR after removing the test finger, and NO SENSOR DETECTED after unplugging during the same record.
Expected outcome: Detection, display, messages, and alarm pass, or are N/A.
11. Test Three-Lead ECG When Used
Action: Verify LA/RA/LL leads-off messages and priority-three tone. At size 4.0 with 1 mV/10 Hz, LIFEPAK 20e accepts 25-31 mm peak-to-peak Lead I and 36-44 mm Lead II.
Expected outcome: Leads-off and gain pass, or are N/A.
12. Test Five-Lead ECG and Analog Output
Action: Perform all five-lead disconnect/gain tests including C lead with exact PIP signals/limits. Test analog output only when applicable.
Expected outcome: Fitted ECG functions and optional output pass.
13. Test Synchronized Defibrillation
Action: Connect therapy output to the defibrillator analyzer—never pacer inputs. Verify Sync LED/R-wave markers. At 2 J, measure each required interface; LIFEPAK 20e accepts 1.0-60 ms.
Expected outcome: Synchronization passes.
14. Test Delivered Energy at 2 J and 70 J
Action: Into the approved 50 Ω load, test required interfaces. LIFEPAK 20e accepts 1.0-3.0 J at 2 J and 59.5-80.5 J at 70 J. Never discharge while connected to a safety analyzer.
Expected outcome: Energy passes; otherwise remove from service for authorized TCP/calibration.
15. Test Battery-Powered 360 J Energy and Charge Time
Action: Disconnect AC, select 360 J, time full charge, and discharge into the defibrillator analyzer. LIFEPAK 20e accepts 306-414 J and 1-10 seconds. Reconnect AC afterward.
Expected outcome: Battery energy and charge time pass.
16. Complete Therapy ECG, R-Wave, Paddle, and Remote-Sync Tests
Action: Complete applicable QUIK-COMBO/paddle ECG gain, positive R-wave, paddle User Test, and remote-sync checks using specified equipment.
Expected outcome: Therapy ECG/sync, paddle controls/contacts, polarity, and remote sync pass.
17. Test Pacing and Patient Impedance When Fitted
Action: Perform pacer leads-off, output including 10/100/200 mA, pulse width at 200 mA, and impedance checks. Record measurements and current limits.
Expected outcome: Pacing and impedance pass, or are N/A.
18. Inspect Battery, AC Power, and CMM Options
Action: Confirm battery/AC indicators, battery operation, charging, cord retention, condition, age, and replacement requirements. Use separate CMM PIP/TCP for its battery, AC, wireless, TrueCPR, and EtCO₂.
Expected outcome: Base and CMM power/options pass.
19. Perform Electrical Safety Tests
Action: Follow exact IEC 62353/IEC 60601 setups. Zero leads; test protective earth and equipment/applied-part/earth leakage for ECG, therapy, and SpO₂. Do not touch high-voltage connections and never defibrillate while connected to the safety analyzer.
Expected outcome: Every required measurement passes.
20. Restore Settings and Complete Readiness Check
Action: Restore customer settings and Manual Access. Exit service mode, reset maintenance prompt only as authorized, reconnect AC, reinstall paper/accessories, verify indicators, repeat final checks, clean, label, and document.
Expected outcome: Device is complete, correctly configured, charged, clean, and ready.
Electrical Safety Testing
Use PIP 3201896-000_C and its exact IEC 62353/IEC 60601 setup. The current exact-model document controls.
- Direct equipment leakage SFC: 15-270 µA at 120 VAC; 15-450 µA at 240 VAC
- Direct ECG applied-part leakage: 2-45 µA
- Direct therapy applied-part leakage: 2-2625 µA
- Direct SpO₂ applied-part leakage: less than 2625 µA
- Earth leakage normal condition: 15-2250 µA
- Earth leakage single-fault condition: 15-2625 µA
Record protective-earth resistance and all polarity/fault results. Do not omit lower bounds; an abnormally low result may indicate incorrect setup. Do not apply LIFEPAK 20e limits to an original LIFEPAK 20 unless its documentation confirms them.
Pass / Fail Criteria
Pass
- Identity, configuration, accessories, options, and documents are confirmed
- Physical condition, controls, connectors, cables, paddles, sensors, printer, and accessories pass
- Power-on, User Test, date/time, controls, pixels, audio, and printer pass
- Installed ECG, SpO₂, pacing, CMM, EtCO₂, wireless, and output tests pass or are N/A
- Sync, energy, charge time, therapy ECG, R-wave, impedance, battery, protective earth, and leakage pass
- Original settings are restored and final readiness passes
Remove From Service
- Exact configuration/current procedure or calibrated equipment is unavailable
- A physical, accessory, power, battery, control, display, printer, cable, paddle, or connector defect affects safety/readiness
- Any self-test, User Test, ECG, therapy, sync, energy, charge-time, pacing, impedance, option, or alarm test fails
- Protective-earth or leakage fails
- Settings cannot be restored or required authorized repair/calibration remains incomplete
Copy/Paste CMMS Work Order Procedure
Follow the complete current PIP from start to finish in published order. This procedure does not replace the manufacturer PIP, TCP, service manual, operating instructions, or CMM procedure.