LIFEPAK 15 Performance Inspection Procedure Rev C 2022

Performance Inspection Procedure

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LIFEPAK®15 Performance Inspection Procedure (PIP)

LIFEPAK® 15 MONITOR/DEFIBRILLATOR _______________________________________________________ Performance Inspection Procedure (PIP)

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LIFEPAK®15 Performance Inspection Procedure (PIP) This Performance Inspection Procedure (PIP) is a set of manual test procedures which are used as an operational closed-case evaluation of the LIFEPAK® 15 defibrillator. This section describes contents of the test procedures you will perform to determine if the device is operating within the required specifications. Perform the PIP as part of a regularly scheduled preventive maintenance routine. Also, perform the PIP after any repair, replacement, or calibration procedure. The Performance Inspection Procedure Checklist is provided as a tool for the recording of PIP test results.

Contents: Scope and Applicability Resource Requirements Test Equipment Test Equipment Verification Workstation Power Test Equipment Requirements Test Instructions PIP - General Instruction PIP - Manual Mode Access PIP - Device Preparation PIP - Exterior Physical Inspection PIP - Device Setup PIP - Power Management PIP - Power On/Self-Test PIP - Auxiliary Power Switching Test PIP - Power Source Management Test PIP - User Test and Date/Time Verification Test PIP - Miscellaneous Function PIP - Temperature Calibration Check PIP - CO2 Tests PIP - CO2 Leakage Test 3207841-000_C ©2022 Stryker

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - CO2 Calibration Check PIP - NIBP Tests PIP-NIBP Leakage Test PIP-NIBP Calibration Check PIP - Printer Tests PIP- Printer Speed Test at 25 mm/sec. PIP- Printer Speed Test at 12.5 mm/sec PIP - Keypad Tests PIP - Audio Test PIP - Invasive Pressure Verification - P1, P2 Testing PIP - SpO2/SpCO/SpMet Tests PIP - Recording Operating Data Testing PIP - ECG Performance Testing PIP-12-LEAD ECG Tests PIP-12-LEAD ECG LEADs Off Detection Test PIP-12-LEAD ECG Gain Test PIP-5-LEAD ECG Tests PIP-5-LEAD ECG LEADs Off Detection Test PIP-5-LEAD ECG Gain Test PIP- 3-LEAD ECG Tests PIP-3-LEAD ECG LEADs Off Detection Test PIP-3-LEAD ECG Gain Test PIP-Analog ECG Output Test (Optional) PIP- Defibrillator/Pacing Testing PIP - QUIK-COMBO Defibrillator Delivered Energy Test PIP - QUIK-COMBO Defibrillator Charge Time Test and Sync Tests PIP- QUIK-COMBO Defibrillator Charge Time Test PIP- QUIK-COMBO Defibrillator Sync Test PIP - QUIK-COMBO Defibrillator ECG Characteristic Tests PIP - QUIK-COMBO Defibrillator ECG Gain Test PIP - QUIK-COMBO Defibrillator ECG Restore Test 3207841-000_C ©2022 Stryker

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - QUIK-COMBO Defibrillator a Positive R-wave Test PIP – Standard Paddles User Test PIP – Standard Paddles Defibrillator Delivered Energy Test PIP - Standard Paddles Defibrillator Charge Time Test and Sync Tests PIP- Standard Paddles Defibrillator Charge Time Test PIP- Standard Paddles Defibrillator Sync Test PIP - Standard Paddles Defibrillator ECG Characteristic Tests PIP - Standard Paddles Defibrillator ECG Gain Test PIP - Standard Paddles Defibrillator ECG Restore Test PIP - Standard Paddles Defibrillator a Positive R-wave 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 PIP – Data Management PIP - Bluetooth Wireless Technology PIP- Leakage Current Tests PIP - Leakage Current Test Setup PIP-Leakage Current Battery Powered Test Setup PIP-Leakage Current ACPA Powered Test Setup PIP - Direct Equipment Leakage and Direct Applied Part Leakage Test Setup PIP - Direct Equipment Leakage Test - Single Fault Condition (SFC) PIP - Direct Applied Part Leakage Test Setup PIP - Direct Applied Part Leakage Test – ECG PIP - Direct Applied Part Leakage Test - Therapy PIP - Direct Applied Part Leakage Test - SpO2 PIP- Leakage Current Test Limits PIP - Disabling/Resetting Maintenance Prompt APPENDIX A - Alternate Setup Methods

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LIFEPAK®15 Performance Inspection Procedure (PIP) Scope and Applicability This PIP applies to the LIFEPAK 15 Defibrillator exclusively. To complete the PIP, you must perform the tests outlined in the PIP Instructions below. All PIP tests must be performed from start to finish in the order presented. Refer to the PIP - Resource Requirements for a listing of the necessary qualifications for PIP equipment, test equipment verification and workstation power. Refer to the PIP - Test Equipment Requirements for a listing of test equipment, including specifications, required to complete the PIP. Use the PIP - Checklist to record your results.

Resource Requirements This section describes the requirements for PIP equipment, PIP test equipment verification and PIP workstation power requirements.

Test Equipment To perform the PIP, Stryker corporate entities must use the equipment listed in the PIP - Test Equipment Requirements table. Non-Stryker entities are encouraged to use equipment listed in the PIP - Test Equipment Requirements table but may substitute test equipment with equivalent specifications - at their own risk.

Test Equipment Verification All test equipment used to perform the PIP must have a current calibration label. The calibration label must be issued by a certified calibration facility.

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LIFEPAK®15 Performance Inspection Procedure (PIP) Test Equipment Requirements Equipment

Specification or Description

Defibrillator analyzer with external

Energy range: 0 to 450 J Load resistance: 50 ±1% Accuracy: +/- 2%, noninductive Waveforms: Simultaneous 12-LEAD output Rates: 30 bpm, 120 bpm, with rate accuracy of ± 1% Amplitude: 1 mV ± 5%, based on LEAD II ECG performance: Amplitudes of LEAD II and LEADs V1-V6 are equivalent. LEAD I = 70% amplitude of LEAD II. Sine wave: 10 Hz @ 1 mV ± 2%, based on LEAD II

noninvasive pacer measurements**

Manufacturer or Part number/ Catalog number (REF) Fluke® Biomedical Impulse 7000DP with QUIK-COMBO adapter accessory 16/7 D/P ADPT104*

Patient simulator (for Blood Pressure measurement)

Blood pressure accuracy: ± 1% full scale, ± 1 mmHg

Fluke Biomedical DNI 215A/217A or Fogg BP-28*

Safety Analyzer

90 V ac rms to 264 V ac rms mains voltage Current range: 0-1999 PA Current accuracy: 5% of reading or 1 digit (whichever is greater) Provides addition ECG snap connections

Fluke Biomedical ESA612*

ESA612 adapter box Decade resistance box Digital pressure meter QUIK-COMBO therapy cable

0 to 9 M: resistance box Resolution: 1; accuracy: ± 1% 1% accuracy for pressure and vacuum

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Fluke Biomedical model 1210 IET RS-200 Resistance Substitute* Fluke Biomedical DPM2Plus* 11113-000004

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LIFEPAK®15 Performance Inspection Procedure (PIP) Equipment

Specification or Description

FAST-PATCH cable assembly

Connects QUIK-COMBO to test posts

Electrode test posts (2 ea.) Stopwatch 3-LEAD ECG cable

5-wire ECG cable 12-LEAD ECG cable

4-wire limb LEAD cable, 12-LEAD ECG

6-wire precordial cable, 12-LEAD ECG

General purpose oscilloscope

SpO2/SpCO/SpMet sensor Lithium-ion battery pak

Elapsed timer (minutes, seconds) Time accuracy: ± 0.5 Sec Standard accessory with the 3-LEAD LP15 monitor/ defibrillator Optional 5-wire cable for LP15 monitor/defibrillator Standard accessory with the 12-LEAD LP15 monitor/ defibrillator Standard accessory with the 12-LEAD LP15 monitor/ defibrillator Standard accessory with the 12-LEAD LP15 monitor/ defibrillator (Optional) Bandwidth: DC to 2 MHz Vertical accuracy: ± 3% (5 mv – 5 v/div.) Horizontal time base accuracy: ± 5% Masimo Rainbow adult reusable sensor Li-ion battery with fuel gauge, battery age is less than 2 years old.

Manufacturer or Part number/ Catalog number (REF) 11110-000052or Physio-Control P/N 3323095 21330-001372 ACCUSPLIT AX725* 11110-000029 11110-000030 11110-000066 11110-000067 11110-000102, 11110-000103 11110-000104, 11110-000105 111111-000018 or 11111-000020

11111-000022

Fluke 190*

11171-000007 21330-001176 40998-000153

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LIFEPAK®15 Performance Inspection Procedure (PIP) Equipment

Specification or Description

NIBP hose Invasive pressure cable

12ft straight hose

Tubing assembly - CO2 leak test Tubing assembly - CO2 calibration Calibration gas Filter Line H set, adult/pediatric Analog ECG output cable QUIK-COMBO to ECG snap terminator cable ECG Snap to Banana Plug cable SpO2 Connector to ECG snap cable Standard paddle Standard paddle leakage adapter Standard paddle QC leakage cable Laptop computer CODE-STAT Reviewer software Battery leakage test adapter Temperature probe simulator Cable Assembly, Temperature Adapter Fogg TP400 Interface cable 3207841-000_C ©2022 Stryker

5% CO2, balance N2 Connects to the System Connector

For use in testing electrical safety For use in testing SpO2 electrical safety Optional therapy delivery accessory Optional - for use in testing Standard Paddle electrical safety Optional - for use in testing Standard Paddle electrical safety Bluetooth wireless technology option installed

Quantity 2, connection to exposed metal in battery well Accuracy ± 0.05 degrees C for all settings

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Manufacturer or Part number/ Catalog number (REF) 21300-007298, 21300-008146 3010-0116 (use with 217A) or Fogg 0365-2178 (use with BP-28) * 21330-000238 21330-000239 21300-001572 11996-000068 11110-000044 Physio-Control P/N 3009139 Physio-Control P/N 3305684 Physio-Control P/N 3305685 ***See Appendix A for alternative 11130-000061 Physio-Control P/N 3206631 Physio-Control P/N 3207066 Dell 630* Physio-Control P/N 3011520 Version 8.0 (minimum version required) Physio-Control P/N 3305682 ***See Appendix A for alternative Fogg TP 400 11140-000078 Physio-Control P/N 3308413 Page 8 of 93

LIFEPAK®15 Performance Inspection Procedure (PIP) Equipment

Manufacturer or Part number/ Catalog number (REF) AC to DC Power Adapter 11140-000072 External Power Extension Cable 11140-000080 DC to DC Power Adapter, LP15 11140-000074 **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 (See Test Equipment section above) ***See Appendix A for alternative test fixture components.

Specification or Description

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LIFEPAK®15 Performance Inspection Procedure (PIP) Test Instructions PIP – General Instruction x

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: Only use accessories approved by Physio-Control.

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Manual Mode Access It is recommended that the device be set up for Manual mode when performing the PIP. NOTE: If you do not wish to change the setup for a device configured with manual access restrictions, it may be necessary to use the reserved technician passcode of 5433 to gain access to Manual mode. NOTE: Be sure to make note of the customer settings to restore the device to the user-selected MANUAL ACCESS configuration at the completion of this PIP. Figure 1.1-Manual mode passcode To perform the device for Manual mode access: 1.

Access the Setup mode as follows: a. Press and hold OPTIONS and EVENT, and then turn the device ON. b.

When the Setup mode passcode prompt appears enter 5433.

Select MANUAL MODE in the Setup menu.

Figure 1.2-Manual mode menu selection

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LIFEPAK®15 Performance Inspection Procedure (PIP)

In the Setup/Manual Mode submenu, set the Manual Access selection to Manual/Direct.

Turn the device OFF by pressing ON for two seconds, and then continue with the next test.

Figure 1.3-Manual mode submenu

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Device Preparation This section describes the inspection and setup procedures to prepare the device for the PIP. x x x

All required PIP tests applicable to the device configuration under test must be performed. The Performance Procedure Checklist is provided as a tool for the recording of test results. To correct failures, see Troubleshooting, and then repeat the PIP.

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Exterior Physical Inspection To perform an exterior physical inspection: 1. Inspect the device exterior for the following: x Damage x Excessive wear x Improper mechanical function x 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. 3. Inspect the rubber feet on the underside of the lower enclosure. Reinstall or replace rubber feet as necessary. 4. Inspect the battery pins. x Tighten loose battery pins (see Battery Pin Replacement section of the LIFEPAK15 Service Manual). x Examine each leaf on the connector pins to make sure it is not cracked or broken. x Replace pins in accordance to the Scheduled Replacement Items section of the LIFEPAK15 Service Manual. 5. Inspect the pins and connector housings of all QUIK-COMBO, standard paddles, and other therapy cables for damage 6. Verify the spring button on the therapy connector is functional prior to engaging a therapy cable into the therapy connector 7. Inspect the ECG, SpO2*, CO2*, NIBP*, IP*, Temp* and system connectors for damage, cracks, or contamination (*if equipped). 8. Inspect the keypads and overlays for damage, cracks and separations. 9. Check all other accessory cables, ECG, SpO2 sensors, CO2 tubing, NIBP tubing, Temperature sensors and related items for expiration dates, general condition, and suitability for use. 10. Inspect carrying strap and mounts (if the device is equipped with them). 3207841-000_C ©2022 Stryker

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Device Setup WARNING: SHOCK HAZARD The device discharges up to 360 joules of electrical energy through the defibrillator cable. You must safely discharge this electrical energy as described in this PIP. Do not attempt to perform this procedure unless you are thoroughly familiar with the operation of the device. 1. Verify two, fully functional, charged, Lithium-ion batteries are showing more than two charge bars Note: A functional charged battery is one that does not return a LOW BATTERY message after turning on the device 2. Insert the two Li-ion batteries into the device. 3. Verify that each battery clicks into position in the battery wells. 4. Install a roll of printer paper into the printer. 5. Connect the QUIK-COMBO therapy cable (or optional standard paddles) to the therapy connector. Note: If the device is outfitted with standard paddles, perform the PIP tests specific to standard paddles instead of the tests specific to QUIK-COMBO.

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Power Management Perform the following Power Management tests: PIP - Power On/Self-Test PIP - Auxiliary Power Switching Test PIP - Power Source Management Test

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Power On/Self-Test: To perform Power On/Self-Test: 1. Turn the device ON. 2. Verify the entire self-test completes in 10 seconds or less Note: The startup screen appears while the device is starting up and performing its self-test. The copyright is formatted as “Physio-Control Inc. (year).” The year shown will vary with software versions. The system software part number is also displayed at the bottom of screen. 3. Verify that the power ON LED remains illuminated after the self-test. 4. Verify that all front panel LEDs flash (except the ON LED, which glows steadily) for approximately 0.5 seconds during the self-test. 5. Verify that the speaker emits a clear, single-beep test tone. 6. Verify that the Service LED is OFF. 7. Verify that the display screen appears similar to figure 1.8. 8. Turn the device OFF and continue with the next test.

Figure 1.8-Display screen

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Auxiliary Power Switching Test To perform Auxiliary Power Switching Test: 1. Connect the power adapter to the power source and the output cable to the Auxiliary Connector at the rear of the device. See the Operating Instructions - AC and DC Power Adapters for more information. 2. Turn on the device and verify that the battery icons appear but neither is highlighted. Note: Battery indications may look slightly different. 3. Unplug the Power Adapter cable from the device Auxiliary Connector. Verify that one of the device battery icons is highlighted.

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - Power Source Management Test To perform Power Source Management Test: 1. Turn the device ON. 2. Verify the device displays the battery status indicators showing the following information: • The presence of batteries in Battery Wells 1 and 2. • Which battery is being used (the battery in use is indicated by a white battery number in a black box) • The state of charge on each battery. • When two batteries are installed prior to turn ON, the device will use the battery with the lowest charge first. 3. Remove Battery 1. Verify the device indicates no battery is in Well 1 and the device is being powered by Battery 2. 4. Reinsert Battery 1 and remove Battery 2. Verify the device indicates no battery is in Well 2 and the device is being powered by Battery 1. 5. Reinsert Battery 2. 6. Turn the device OFF and continue with the next test.

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LIFEPAK®15 Performance Inspection Procedure (PIP) PIP - User Test and Date/Time Verification Tests To perform User Test and Date/Time Verification Tests: 1. Turn the device ON. 2. Press OPTIONS to access the Options menu 3. Select USER TEST. The device automatically performs the following tasks: x Performs self-tests. x Charges to 10 joules and discharges internally (this energy is not accessible at the therapy connector). x Prints a Pass/Fail report. 4. Verify on the printout that the device passes the user test and that the correct date and time values are also displayed on the printout. Note: If the date and time are incorrect, reset using the Options/Date/Time menu. 5. Turn the device OFF and continue with the next test.

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LIFEPAK Defibrillators

LIFEPAK 15 Performance Inspection Procedure Rev C 2022