Stryker LIFEPAK 20 Installation instructions

LIFEPAK®20
Performance Inspection Procedure (PIP)
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Page 1 of 61
LIFEPAK®20 MONITOR/DEFIBRILLATOR
_______________________________________________________
Performance Inspection Procedure (PIP)

LIFEPAK®20
Performance Inspection Procedure (PIP)
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This Performance InspectionProcedure (PIP) is a set of manual test procedures which are used asan operational closed-case evaluation of
the LIFEPAK®20 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 recordingof PIP test results.
Contents:
PIP - Scope and Applicability
PIP - Resource Requirements
PIP - Test Equipment
PIP - Test Equipment Verification
PIP - Workstation Power
PIP - Test Equipment Requirements
PIP - Test Instruction
PIP - General Instruction
PIP - Exterior Physical Inspection/Cleaning Paddles
PIP - Device Setup
PIP - Manual Mode Access
PIP - Power On/Self-Test
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

LIFEPAK®20
Performance Inspection Procedure (PIP)
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PIP- 3-Lead ECG Tests
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
PIP- Analog ECG Output (Optional Test)
PIP- Defibrillator/Pacing Testing
PIP - Quik-Combo Defibrillator Sync Tests at 2J
PIP - QUIK-COMBO Defibrillator Delivered Energy Tests at 2J and 70 J
PIP - Quik-Combo Defibrillator Delivered Energy and Charge Time Tests at 360 J (Battery Powered)
PIP - Quik-Combo Defibrillator ECG Characteristic Tests
PIP - QUIK-COMBO Defibrillator ECG Gain Test
PIP - QUIK-COMBO Defibrillator a Positive R-wave Test
PIP - Quik - Combo Sync Remote Test
PIP - Standard Paddles Users Test
PIP - Standard Paddles Defibrillator Sync Test at 2J
PIP - Standard Paddles Defibrillator Delivered Energy Tests at 2J and 70J
PIP - Standard Paddles Defibrillator Delivered Energy and Charge Time Tests at 360 J (Battery Powered)
PIP - Standard Paddles ECG Characteristic Tests
PIP - Standard Paddles Defibrillator ECG Gain Test
PIP - Standard Paddles Defibrillator a Positive R-wave Test
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

LIFEPAK®20
Performance Inspection Procedure (PIP)
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Electrical Safety
PIP- Safety Analyzer Setup for IEC62353 Testing
PIP- Protect Earth Resistance Test
PIP - Leakage Current Test
PIP - Leakage Current Test Setup
PIP- Direct Equipment Leakage Test at Single Fault Condition (SFC)
PIP- Safety Analyzer Setup on Direct Applied Part Leakage Tests
PIP- Direct Applied Part Leakage Test - ECG
PIP- Direct Applied Part Leakage Test -Therapy
PIP- Direct Applied Part Leakage Test -SPO2
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

LIFEPAK®20
Performance Inspection Procedure (PIP)
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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.
Refer to the PIP - Resource Requirements for a listing of the necessary qualifications for PIP equipment, test equipment verification,
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, PIP workstation power.
Test Equipment
To perform the PIP, you must use the equipment listed in the PIP - Test Equipment Requirements table. Although the table lists
specific test equipment by manufacturer, test equipment with equivalent specifications may be substituted. Refer to the test equipment
manufacturer’s operating instructions for usage details where not specifically covered herein.
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.
Workstation Power
The AC line power to the workstation must be connected to a grounded power source.

LIFEPAK®20
Performance Inspection Procedure (PIP)
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Test Equipment Requirements
Equipment
Specification or Description
Manufacturer or Part number or
Catalog number
Defibrillator analyzer with external noninvasive
pacermeasurements*
Energy range: 0 to 450 J
Load resistance: 50
ohms ±1% Accuracy:
+/- 2%, non-
inductive
Waveforms: S i mu lt an eous 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 LeadII and
Leads V1-V6are equivalent. LeadI = 70%
amplitude of Lead II.
Sine wave: 10 Hz @ 1 mV± 2%, based on
Lead II
Fluke® Biomedical Impulse
7000DP with QUIK-COMBO
adapter accessory 16/7 D/P
ADPT10 4**
Safety Analyzer
90 V ac rms to 264 V ac rms mains voltage
Current range: 0-1999 A
Current accuracy: 5% of rea d i n g or 1 digit
(whichever is greater)
Fluke Biomedical ESA612*
Decade resistance box
0 to 9 M resistance box
Resolution:1 ; accuracy: ± 1 %
IET RS-200 Resistance Su bstit u t e *
Remote Sync Test Pulse Generator
* **
21300-007574
SPO2 Leakage Cable
21300-007561, 21300-005487,
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

LIFEPAK®20
Performance Inspection Procedure (PIP)
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Equipment
Specification or Description
Manufacturer or Part number or
Catalog number
DB9 Male/DB 9 Female cable (optional)
MXT100
Masimo Oximeter Adult finger sensor (LNOP DCI,
Adult SPO2 sensor, reusable)
11171-000007
Massimo Extension Cable (PC04-Patient Cable,
SPO2, 4ft)
11171-000006
Cable Assembly, Fast Patch (use for 7000DP and
RS200)
11110-000052
Electrode test posts (use for 7000DP and RS200)
21330-001372
Cable, Test, Service, LP CR2
3323095
Cable Assembly, 3 Lead ECG
11110-000029
11110-000030
Cable Assembly, 5 Lead ECG
11110-000066
Cable Assembly, Analog ECG Output
11110-000067
Cable, QUIK-COMBO to Snap Termination
3009139
Adapter -Test, Paddles, Leakage, LP12 & LP20
3206631
Cable, Test, ECG snap to banana plug
3305684
QUIK-COMBO Leakage Cable
3207066
1210 Adapter (for ESA612)
Fluke 1210
BJ2 ECG Input Jack Adapter (1 for ESA612 and 2
for 1210 Adapter)
Fluke - BJ2
Banana plug cable (connect between ESA612
and Battery eliminators)
Fluke ESA612 Accessory kit
*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.

LIFEPAK®20
Performance Inspection Procedure (PIP)
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Test Instructions
PIP - General Instruction
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.

LIFEPAK®20
Performance Inspection Procedure (PIP)
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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.
3. Inspect the rubber feet on the underside of the lower enclosure. Reinstall or replace rubber feet as necessary.
4. Inspect the Therapy, ECG, SpO2 (if equipped), DB-9, DB-15, AED door, and IrDA connectors for damage and or cracks.
5. Inspect the keypads and overlays for damage, cracks, and separations.
6. Check all other accessory cables, Paddles, ECG, SpO2 sensors, and related items for expiration dates, general condition, and
suitability for use.
7. Inspect carrying strap and mounts (if the device is equipped with them).
To perform Cleaning Paddles:
1. Disconnect the adult paddle plate from the paddle assembly.
2. Clean the spring contact of the adult paddle with alcohol.
3. Clean the pediatric electrode surface with alcohol.
4. Reattach the adult paddle plate to the paddle assembly.

LIFEPAK®20
Performance Inspection Procedure (PIP)
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Page 10 of 61
PIP - Device Setup
WARNING
SHOCK HAZARD
The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in these operating
instructions, this energy may cause serious injury or death. Do not attempt to operate this device unless thoroughly familiar
with these operating instructions and the function of all controls, indicators, connectors, and accessories.
1. Connect the AC Power cable into the device.
2. Install a roll of printer paper into the printer.
Figure 1.1: Device Setup