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- Page 1 ® LIFEPAK monitor/defibrillator Test Calibration Procedure (TCP) ® LIFEPAK monitor/defibrillator _____________________________________________________ Test Calibration Procedure (TCP) 3340124-001_AD ©2024 Stryker CONTENTS Page 1 of 22...
- Page 2 Test Calibration Procedure (TCP) This document contains the Test and Calibration Procedures (TCP) for the LIFEPAK 35 monitor/defibrillator. Perform the procedures in this section as necessary after replacing device components or to correct out-of-specification conditions detected during the PIP. The following procedures may be performed in any order.
- Page 3 This TCP applies to the LIFEPAK 35 monitor/defibrillator exclusively. You may perform the procedures outlined in this section in any order. Note: Prior to its return to active use, the LIFEPAK 35 monitor/defibrillator must successfully pass all portions of the closed- case Performance Inspection Procedures (PIP) anytime the device is opened for repair, component replacement, upgrade, or after calibration.
- Page 4 All test equipment used to perform the TCP must have a current calibration label. The calibration label must be issued by a certified calibration facility. TCP - Personnel qualifications Service personnel who perform the TCP must be thoroughly familiar with the operation of the LIFEPAK 35 and must meet at least one of the following requirements (or the equivalent ): •...
- Page 5 PN: 3335630-001 Cable, Therapy Plugs Defibrillator Isolation Test Stryker PN: 21330-007736 Load Assy, Cable, Service Test, Use to perform Defib Isolation test Stryker PN: 3344955 -000 Leakage USB GND, LIFEPAK 35 LIFEPAK FLEX Lithium-Ion Battery, LI-ION, LIFEPAK 35 Stryker 11335-000001...
- Page 6 Assy, Tubing, Calibration Stryker PN: 3335916-003 Test, MDT CO2 Chem- Gas, Mixture, 5% CO2, 20.6 % O2, BAL, N2 Stryker 21300-001572 Calibration, Aerosol AC Power Cord Tripp Lite or P007-L03 or equivalent equivalent 3340124-001_AD ©2024 Stryker CONTENTS Page 6 of 22...
- Page 7 1. Verify two, fully functional, charged, LIFEPAK FLEX Lithium-ion batteries are showing more than two charge bars. 2. Insert the two Li-ion batteries into the device. 3. Verify that each battery clicks into position in the battery wells. 4. Connect LIFEPAK access port cable between DUT and PC. 3340124-001_AD ©2024 Stryker CONTENTS Page 7 of 22...
- Page 8 7. When you see the INSTALLSHIELD WIZARD COMPLETED screen, make sure the LAUNCH PSST TOOL checkbox is selected, and then click FINISH. The application shall be installed in C:\ProgramData\Microsoft\Windows\Start Menu\Programs\Stryker\ProCare Service Support Tool 8. Once installed, launch PSST and follow the onscreen instructions to connect a device and proceed to the Service Commands menu.
- Page 9 Defibrillator energy tests include the following: • TCP – Defibrillator energy calibration • TCP – Delivered energy verification test • TCP – Delivered output waveform test • TCP – Defibrillator isolation test 3340124-001_AD ©2024 Stryker CONTENTS Page 9 of 22...
- Page 10 NOTE: Ensure proper connections to the defibrillator analyzer. To avoid damage to the analyzer or defibrillator, do NOT apply defibrillator pulses to the pacer inputs of the analyzer. 3. Set the defibrillator analyzer to measure ENERGY, using the appropriate scale. 4. Turn the device ON. 3340124-001_AD ©2024 Stryker CONTENTS Page 10 of 22...
- Page 11 9. Take note of the delivered energy values shown on the defibrillator analyzer. Repeat steps 5-7 for 360J. TCP – PSST 10. Access the Service Commands screen within SST. See Access. 11. Select Defibrillator Energy Calibration in the Service Commands screen. 3340124-001_AD ©2024 Stryker CONTENTS Page 11 of 22...
- Page 12 ® LIFEPAK monitor/defibrillator Test Calibration Procedure (TCP) 12. Select RUN on the Service Commands screen. 3340124-001_AD ©2024 Stryker CONTENTS Page 12 of 22...
- Page 13 16. If the Energy Calibration Error message appears, an error code is written into the device Service Log and the front panel Service LED illuminates. 17. Select DONE on the SST screen. 18. Turn the device OFF when the calibration procedure is complete. 3340124-001_AD ©2024 Stryker CONTENTS Page 13 of 22...
- Page 14 6. Verify that the defibrillator analyzer shows an energy level as specified in the following table. Delivered Energy Low Limit High Limit 10 J 10.8 50 J 47.6 52.4 200 J 360 J 3340124-001_AD ©2024 Stryker CONTENTS Page 14 of 22...
- Page 15 5. Push CHARGE button on the keypad and wait for the device to reach full charge. 6. Push the shock button on the keypad to discharge the device energy into the defibrillator analyzer. 3340124-001_AD ©2024 Stryker CONTENTS Page 15 of 22...
- Page 16 7. Verify that the waveform meets the specifications as shown in the following table. Phase 1 Peak Current Phase 1 Pulse Width Phase 2 Pulse Width 6.85ms 7.85 ms 4.4 ms 5.5 ms 3340124-001_AD ©2024 Stryker CONTENTS Page 16 of 22...
- Page 17 Item 2: 3205570-000 Item 3: 3344955-000 2. Verify the defibrillator analyzer is on and set to measure ENERGY. If it is not set to ENERGY, press the ENRG softkey. 3. Turn the device ON. 3340124-001_AD ©2024 Stryker CONTENTS Page 17 of 22...
- Page 18 8. Verify device displays message “Energy Delivered”. 9. Verify the defibrillator analyzer did not detect any energy reading. 3340124-001_AD ©2024 Stryker CONTENTS Page 18 of 22...
- Page 19 Note: To complete the warm-up period, the device must be on for a total of 20 minutes before proceeding with the calibration of the CO2 module. 1. Turn the device ON. TCP – PSST 2. Access the Service Commands screen within SST. See access. 3. Select CO2 CALIBRATION on the Service Commands screen. 3340124-001_AD ©2024 Stryker CONTENTS Page 19 of 22...
- Page 20 4. Connect the calibration gas canister to the front panel CO2 connector using a standard CO2 Filter Line and the CO2 calibration kit as shown in the following Figure. Figure 3 In Figure 3: Item 1: 21300-001572 Item 2: 3335916-003 5. Press and hold the spray nozzle to apply calibration gas. 3340124-001_AD ©2024 Stryker CONTENTS Page 20 of 22...
- Page 21 9. Verify that the SUCCESS screen appears. 10. If the CO2 Calibration Error message appears, an error code is written into the device Service log and the front panel Service LED illuminates. 11. Power off DUT. 3340124-001_AD ©2024 Stryker CONTENTS Page 21 of 22...
- Page 22 _________________________________________________________ ® LIFEPAK monitor/defibrillator ___________________________________________________________________________________ Test Calibration Procedure (TCP) Specifications are subject to change without notice. For further information, call Stryker at 1 800 STRYKER or visit stryker.com Publication date: 2024/07 3340124-001 Rev AD Copyright © 2024 Stryker...
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