Stryker LIFEPAK 20 Installation instructions

LIFEPAK®20
Performance Inspection Procedure (PIP)
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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

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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

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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

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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.

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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

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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.

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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.

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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.

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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

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Performance Inspection Procedure (PIP)
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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.
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.
2. Select MANUAL MODE in the Setup menu.
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

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PIP - Power Self-Test
To perform the Power On/Self-Test:
1. Press the ON button to initiate the device nominal five-second power-on self-
test routine. Listen for a single tone from the speaker and then three distinct
beeps from the sonalert (AC loss alert).
2. Verify that all lamps light momentarily except for the ON and AC mains
indicators which remain on throughout self-test.
Note: The initial display indicates self-test in progress, as shown in
Figure 1.3.
3. Verify that the device completes the Power On sequence.
4. Verify that AC Main indicator remains ON.
5. Verify that the SERVICE INDICATOR is OFF.
Figure 1.3: Power Self -Test

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PIP - User Test and Date/Time Verification Tests
To perform the User Test and Date/Time Verification Tests:
1. Connect the Quik-Combo and Test Plug into the device.
2. Turn the device ON.
3. Press OPTIONS to access the Options menu.
4. Select USER TEST from the Option menu. When asked to Start user test.
Select Yes and confirm using the Speed Dial.
5. Confirm the printed results that the device passes the user test and that the
correct date and time values are displayed on the printout as shown in
Figure 1.4.
Note: If the date and time are incorrect, reset using the
Options/Date/Time menu.
6. Turn the device OFF.
Figure 1.4: User Test and Date/Time Printout

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PIP - SPO2 Test
To perform SPO2
Test
:
1. Turn the device ON.
2. Connect the SpO2 finger probe to the SpO2 connector as shown in Figure 1.5.
3. Verify the SpO2 parameter region appears on the display.
4. Place your index finger into the SpO2 finger probe. Allow several seconds for the probe to
find your pulse.
5. Confirm the SpO2 reading is between 50 % to 100 %.
6. Remove finger from SpO2 finger probe. Message should display on screen: SpO2 Check
Sensor with audible alarm.
7. Unplug SpO2 finger probe from the device; while on current patient record, message should
display: SpO2 No Sensor Detected.
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

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PIP - Keypad Verification Tests
To perform Keypad Verification Tests:
1. Select TESTS in the Service menu.
2. Select BUTTONS in the Service/Tests submenu as shown in Figure 1.6.
3. Press each front panel button when prompted by the flashing button
legend (although you may press the buttons in any order).
4. Verify with each button pressed that its associated text box is highlighted.
Note: A failure is indicated by a text box that is not highlighted. It is
normal for the buttons with up/down arrows to highlight only the
arrows.
5. Press the switch located between the OPTIONS and PAUSE buttons.
Note: The switch is hidden in the elastomer keypad.
6. Verify the TEST COMPLETE message appears on the bottom of the
screen and the 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

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PIP - Pixels Verification Test
To perform Pixels Verification Test:
1. Select TESTS in the Service menu.
2. Select PIXELS in the Service/Tests submenu. The pixels test screen appears, as shown
in Figure 1.7.
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

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PIP - Audio Verification Test
To perform Audio Verification Test:
1. Select VOICE/TONE from the Service/Tests submenu as shown in Figure
1.8.
2. Select START to produce voice prompts from the speaker.
3. Confirm that the voice prompts are clearly audible and reproduced without
distortion.
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

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Printer Verification @ 25 mm/sec
1. Select PRINTER in the Service/Tests submenu.
2. Select START to print a test strip.
3. Inspect the test strip for the following attributes:
a. The large “X” form prints without missing dots.
b. Four horizontal lines print (one very close to the lower paper margin).
c. The character set prints clearly without broken characters.
d. Vertical lines spaced 25 mm ±1mm (approx. 24 to 26 mm.) apart print
correctly.
4. Open the printer door and verify the CHECK PRINTER message appears at
the bottom of the screen.
5. Remove the printer paper, and then close the printer door.
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

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PIP - ECG Performance Testing
ECG Performance Testing consist of:
PIP - ECG Performance Testing
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

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PIP - 3-Lead ECG Tests
Note: Perform this test if 3-lead ECG cable is used. Otherwise, skip to the next test.
The 3-Lead ECG tests consist of:
PIP - 3-Lead ECG Leads Off Detection Test
PIP - 3-Lead ECG Gain Test
PIP - 3-Lead ECG Leads Off Detection Test
1. Connect the 3-Lead ECG cable between the device and Impulse 7000DP as
shown in Figure 1.10.
2. Set the Impulse 7000DP output to a 1-mv, 10-Hz sine wave.
3. Set the device LEAD selection to Lead II.
4. Remove the LA lead from the Impulse 7000DP, and verify the device displays
the ECG LEADS OFF message and a repeating priority 3 tone shall sound when
the Lead is removed. Reconnect the LA lead.
5. Remove the RA lead from the Impulse 7000DP, and verify the device displays
the RA LEADS OFF message and a repeating priority 3 tone shall sound when
the Lead is removed. Reconnect the RA lead.
6. Remove the LL lead from the Impulse 7000DP, and verify the device displays
the 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