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Stryker LIFEPAK 20 Inspection Procedure
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Stryker LIFEPAK 20 Inspection Procedure

Stryker LIFEPAK 20 Inspection Procedure

Performance inspection procedure monitor/defibrillator
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®
LIFEPAK
20
Performance Inspection Procedure (PIP)
®
LIFEPAK
20
_______________________________________________________
Performance Inspection Procedure (PIP)
3201896-000_B
©2019 Stryker
MONITOR/DEFIBRILLATOR
--- CONTENTS ---
Page 1 of 61

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Summary of Contents for Stryker LIFEPAK 20

  • Page 1 ® LIFEPAK Performance Inspection Procedure (PIP) ® LIFEPAK MONITOR/DEFIBRILLATOR _______________________________________________________ Performance Inspection Procedure (PIP) 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 1 of 61...
  • Page 2 PIP - User Test and Date/Time Verification Test PIP - SpO2 PIP - Keypad Verification Tests PIP - Pixels Verification Test PIP - Audio Verification Test PIP - Printer Verification Tests PIP - ECG Performance Testing 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 2 of 61...
  • Page 3 PIP - Standard Paddles Sync Remote Test PIP - Pacer Characteristic Tests PIP - Pacer Leads-Off Detection Test PIP - Pacer Output Current Test PIP - Pacer Pulse Width Test PIP - Patient Impedance Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 3 of 61...
  • Page 4 PIP - Safety Analyzer Setup on Earth Leakage Tests PIP- Earth Leakage Test at Normal Condition (NC) PIP- Earth Leakage Test at Single Fault Condition (SFC) PIP- Restore Customer Setting 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 4 of 61...
  • Page 5 Scope and Applicability The PIP applies to the LIFEPAK 20 Defibrillator exclusively. To complete the PIP, you must perform the manual test outlined in the PIP - Instructions below. All PIP tests must be performed from start to finish in the order presented.
  • Page 6 21300-007561, 21300-005487, SPO2 Leakage Cable 21300-007562 AC Power Cable Commercial Accessory –Test Plug, Quik-Combo 11113-000002 Paddle Assembly - Detachable, LP20 11130-000037 QUIK-COMBO Therapy Cable 11110-000040 50 mm Recorder Paper 11240-000013 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 6 of 61...
  • Page 7 *Some energy meters are not accurate for biphasic waveforms; contact your defibrillator analyzer’s manufacturer for more information. **Equivalent equipment is required to meet the specifications listed in the specification column. ***A function generator can be used alternatively to the Remote Sync Test Pulse Generator. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 7 of 61...
  • Page 8  This section lists the general instructions for performing the Performance Inspection Procedure (PIP).  Perform the PIP in the order presented.  Use the Performance Inspection Procedure Checklist to record your results. WARNING POSSIBLE EQUIPMENT DAMAGE Only use accessories approved by Physio-Control. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 8 of 61...
  • Page 9 PIP - Exterior Physical Inspection/Cleaning Paddles To perform an exterior physical inspection: 1. Inspect the LIFEPAK 20 exterior for the following: Damage, excessive wear, improper mechanical function, and damaged connectors. 2. Pick up and turn over the device and listen for loose or rattling hardware. Locate any loose or rattling hardware, and then tighten or replace it.

  • Page 10: Shock Hazard

    1. Connect the AC Power cable into the device. 2. Install a roll of printer paper into the printer. Figure 1.1: Device Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 10 of 61...
  • Page 11 3. In the Setup/Manual Mode submenu, set the Manual Access selection to Manual/Direct as shown in Figure 1.2. 4. Turn the device OFF by pressing ON for two seconds. Figure 1.2: Manual Mode Access 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 11 of 61...
  • Page 12 3. Verify that the device completes the Power On sequence. 4. Verify that AC Main indicator remains ON. Figure 1.3: Power Self -Test 5. Verify that the SERVICE INDICATOR is OFF. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 12 of 61...
  • Page 13 Figure 1.4. Note: If the date and time are incorrect, reset using the Figure 1.4: User Test and Date/Time Printout Options/Date/Time menu. 6. Turn the device OFF. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 13 of 61...
  • Page 14 Note: Alarms will clear when device is turned off and new patient record started the next time the device is turned on again. 8. Turn the device OFF. Figure 1.5: SPO2 Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 14 of 61...
  • Page 15 Service LED is not on. 7. Press the SPEED DIAL to exit at the end of the test. 8. Continue with the next test while still in Service mode. Figure 1.6: Keypad Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 15 of 61...
  • Page 16 3. Carefully examine the screen for any anomalies. Rotate SPEED DIAL to scroll through test screens. 4. Press the SPEED DIAL to exit the test. 5. Continue with the next test while still in Service mode. Figure 1.7: Pixels Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 16 of 61...
  • Page 17 Note: You can listen to a complete replay of all voice prompts and tones, but it is not required for verification of this function. 4. Continue with the next test while still in Service mode. Figure 1.8: Audio Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 17 of 61...
  • Page 18 6. Verify the CHECK PRINTER message appears at the bottom of the screen. 7. Select PREVIOUS PAGE twice to return to the Service menu. 8. Continue with the next test. Figure 1.9: Printer Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 18 of 61...
  • Page 19 PIP - 3-Lead ECG Leads Off Detection Test PIP - 3-Lead ECG Gain Test PIP- 5-Lead ECG Tests PIP - 5-Lead ECG Leads Off Detection Test PIP - 5-Lead ECG Gain Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 19 of 61...
  • Page 20 LL LEADS OFF message and a repeating priority 3 tone shall sound when the Lead is removed. Reconnect the LL lead. 7. Continue with the next test with this setup in place. Figure 1.10: 3 Lead ECG Leads Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 20 of 61...
  • Page 21 6. Print five seconds of ECG Lead II, and confirm the printed signal amplitude is 36 mm to 44 mm, peak-to-peak as shown in Figure 1.11. 7. Turn the printer OFF Figure 1.11: ECG Gain at Lead I and Lead II 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 21 of 61...
  • Page 22 12. Verify the device displays a C LEADS OFF message and a repeating priority 3 Setup tones shall sound when the Lead is removed. Reconnect the C1/V1 lead. 13. Continue to the next test with this setup in place. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 22 of 61...
  • Page 23 44 mm, peak-to-peak as shown in Figure 1.13. 7. Repeat steps 5 and 6 for C Lead. 8. Turn the printer OFF. Figure 1.13: ECG Gain at Lead I and Lead II 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 23 of 61...
  • Page 24 5. Verify the amplitude of the signal displayed on the oscilloscope is between 0.90Vp-p and 1.10Vp-p. 6. Disconnect the ECG output cable from the device and oscilloscope. 7. Turn the device OFF. Figure 1.14: Analog ECG Output Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 24 of 61...
  • Page 25 PIP - Standard Paddles Sync Remote Test PIP - Pacer Characteristic Tests PIP - Pacer Leads-Off Detection Test PIP - Pacer Output Current Test PIP - Pacer Pulse Width Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 25 of 61...
  • Page 26 9. Verify the defibrillator analyzer measures a sync R-wave is within 1.0 ms to 60ms. 10. Continue to the next test with this setup in place. Figure 1.15: Quik-Combo Defibrillator Delivered Energy Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 26 of 61...
  • Page 27 6. Verify the defibrillator analyzer indicates the delivered energy is within 59.5 J to 80.5J. Note: Perform the TCP- Defibrillator Energy Calibration if the delivered energy falls outside of the acceptable output range. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 27 of 61...

  • Page 28: Shock Hazard

    Note: Perform the TCP- Defibrillator Energy Calibration if the delivered energy falls outside of the acceptable output range. 7. After testing is complete reconnect the AC power cable to the device. Figure 1.16: Quik-Combo Defibrillator Energy and Charge Time Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 28 of 61...
  • Page 29 4. Print 10 seconds of paddles ECG and confirm the printed signal amplitude is 36 mm to 44 mm, peak-to-peak as shown in Figure 1.17. Figure 1.17: ECG Gain at Paddles Lead 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 29 of 61...
  • Page 30 4. Print 10 seconds of paddles ECG recorded on printer paper. 5. Turn the printer OFF. 6. Confirm the R-Wave polarity on the paper matches image as shown in Figure 1.18. Figure 1.18: A Positive R-Wave 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 30 of 61...
  • Page 31 (for SW-26 or above). Figure 1.19: Quik-Combo 12. On the Manual Mode setup page, set the device to Remote Sync Sync Remote Test Setup OFF. 13. Turn the device OFF. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 31 of 61...
  • Page 32 Note: The Device will automatically turn off after successfully completing the test. 7. Proceed to next test. Figure 1.20: Standard Paddles User Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 32 of 61...
  • Page 33 Note: To avoid damage to the Defibrillator Analyzer, do not apply any defibrillator pulses to the pacer inputs of the analyzer. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 33 of 61...
  • Page 34 9. Verify the defibrillator analyzer measures a sync R-wave is within 1.0 ms to 60ms. 10. Continue to the next test with this setup in place. Figure 1.21: Standard Paddles Defibrillator Energy Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 34 of 61...
  • Page 35 6. Verify the defibrillator analyzer indicates the delivered energy is within 59.5 J to 80.5J. Note: Perform the TCP- Defibrillator Energy Calibration if the delivered energy falls outside of the acceptable output range. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 35 of 61...
  • Page 36 7. After testing is complete reconnect the AC power cable to the device. Figure 1.22: Standard Paddles Defibrillator Energy and Charge Time Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 36 of 61...
  • Page 37 4. Print 10 seconds of paddles ECG and confirm the printed signal amplitude is 36 mm to 44 mm, peak-to-peak as shown in Figure 1.23. Figure 1.23: ECG Gain of STD Paddles 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 37 of 61...
  • Page 38 4. Print 10 seconds of paddles ECG recorded on printer paper. 5. Turn the printer OFF. 6. Confirm the R-Wave polarity on the paper matches image as shown in Figure 1.24. Figure 1.24: A Positive R-Wave 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 38 of 61...
  • Page 39 20 version or below) or switches out of remote sync mode (for SW-26 or above). Figure 1.25: Standard Paddles Sync 12. On the Manual Mode setup page, set the device to Remote Sync OFF. Remote Test Setup 13. Turn the device OFF 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 39 of 61...
  • Page 40 Performance Inspection Procedure (PIP) PIP – Pacer Characteristic Tests The pacer characteristics consist of: PIP – Pacer Leads-Off Detection Test PIP – Pacer Output Current Test PIP – Pacer Pulse Width Test 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 40 of 61...
  • Page 41 8. Verify the Pacing/Connect Electrodes overlay appears, accompanied by an audible alarm. 9. Reconnect the test post adapter snap. 10. Verify the Pacing/Connect Electrodes overlay disappears and the alarm stops. Figure 1.26: Pacer Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 41 of 61...
  • Page 42 Note: Perform TCP – Pacer Self-Calibration if the peak pacer current falls outside the acceptable output range. Peak Current Level (mA) Acceptable Output (mA) 0 to 20 90 to 110 180 to 220 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 42 of 61...
  • Page 43 3. Verify the measured pacer pulse width is between 19.0 and 21.0 ms. Note: Perform TCP - Pacer Self-Calibration if the peak pacer current falls outside the acceptable output range. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 43 of 61...
  • Page 44 7. Set the decade resistance box to 182 ohms. 8. Verify the PADDLES LEADS OFF message are not visible. 9. Remove the decade resistance box. 10. Turn the device OFF. Figure 1.27: Patient Impedance Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 44 of 61...
  • Page 45 2. Press the F4/MORE button. 3. Press the F2/INSTRUMENT button. 4. Press the F1/STANDARD button. 5. Press the UP/DOWN arrows to select the 62353 Standard. 6. Press the DONE button. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 45 of 61...
  • Page 46 4. Measure the resistance of AC power cord ground conductor per figure 1.30a. Record the resistance value on the PIP checklist. The measured value must be below 0.1 ohms. Figure 1.30a 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 46 of 61...
  • Page 47 Step 4 from the Figure 1.30b value obtained in Step 7. The calculated value must be less than 0.2 ohms. Record the calculated value on PIP checklist. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 47 of 61...
  • Page 48 POLARITY switch in both NORMAL [NC] and REVERSED [RM] positions). The earth ground is NOT intact during these measurements. Safety Analyzer setup instructions are specific to the Fluke Biomedical ESA612. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 48 of 61...
  • Page 49 1. Connect the Banana cable (Item 6) between the Safety Analyzer ESA612 (at V/ohms/A) and the Ground stud. 2. Connect the customer ECG Lead cable (Item 1) between the LIFEPAK 20 and the 1210 box. Connect Item 5 between the 1210 box and the Safety Analyzer ESA612 at RA snap.
  • Page 50 LP20 LEAKAGE CURRENT TEST SETUP Quik-Combo Cable Std Paddles LP20 DEVICE FACE LP20 DEVICE FACE Connect Paddles To Device --(8)-- LP20 DEVICE REAR LP20 DEVICE REAR Figure 1.28: LP20 Leakage Current Test Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 50 of 61...
  • Page 51 4. Verify the device AC Mains LED is ON. 5. Verify the measured current is between 15 A and 270 A (120 VAC) or between 15 A and 450 A (240 VAC). 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 51 of 61...
  • Page 52 During Direct Applied Part Leakage tests, high voltage is present on the Safety Analyzer electrode snaps. Do not touch snaps or device connections during these tests. WARNING POSSIBLE EQUIPMENT DAMAGE Do not defibrillate when connected to the safety analyzer! 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 52 of 61...
  • Page 53 2. Press the F4/MORE button. 3. Press the UP/DOWN arrows to select the appropriate A.P groups as shown in Figure 1.29. 4. Press F1/SELECT then F1/Direct A.P. Figure 1.29: Direct Applied Part Leakage Setup 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 53 of 61...
  • Page 54 3. Press the TEST button to measure the Direct Applied Part Leakage current. 4. Verify the device AC Mains LED is ON. 5. Verify the measured current is between 2 A and 45 A (120 and 240 VAC). 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 54 of 61...
  • Page 55 3. Press the TEST button to measure the Direct Applied Part Leakage current. 4. Verify the device AC Mains LED is ON. 5. Verify the measured current is between 2 A and 2625 A (120 VAC and 240 VAC). 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 55 of 61...
  • Page 56 ® LIFEPAK Performance Inspection Procedure (PIP) PIP-Direct Applied Part Leakage Test-SPO2 Note: Execute this test if the LIFEPAK 20 is equipped with SpO2 WARNING POSSIBLE EQUIPMENT DAMAGE Do not defibrillate when connected to the safety analyzer! 1. Turn the device ON.
  • Page 57 2. Press the F4/MORE button. 3. Press the F2/INSTRUMENT button. 4. Press the F1/STANDARD button. 5. Press the UP/DOWN arrows to select the 60601 Standard. 6. Press the DONE button. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 57 of 61...
  • Page 58 Note: Pause briefly between switching polarity to prevent damage to the defibrillator. 4. Verify the device AC Mains LED is ON. 5. Verify the measured current is between 15 A and 2250 A (120 VAC and 240 VAC). 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 58 of 61...
  • Page 59 Note: Pause briefly between switching polarity to prevent damage to the defibrillator. 4. Verify the device AC Mains LED is ON. 5. Verify the measured current is between 15 A and 2625 A (120 VAC and 240 VAC). 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 59 of 61...
  • Page 60 ® LIFEPAK Performance Inspection Procedure (PIP) PIP-Restore Customer Settings Restore customer settings... 1. Enter SETUP menu. 2. Choose MANUAL MODE. 3. Choose MANUAL ACCESS. 4. Choose CUSTOMER’S NORMAL SETTINGS. 3201896-000_B ©2019 Stryker --- CONTENTS --- Page 60 of 61...
  • Page 61 ________________________________________________________________________________ ® LIFEPAK MONITOR/DEFIBRILLATOR _____________________________________________________________________________ Performance Inspection Procedure (PIP) For further information, please call Stryker at 1.800.442.1142 or visit www.strykeremergencycare.com Stryker Stryker Australia Pty Ltd 11811 Willows Road NE 8 Herbert Street Redmond, WA 98073-9708 USA St Leonards Tel: 425.867.4000 NSW 2065 Fax: 425.458.1404...