Stryker LIFEPAK 20 Montageanleitung

LIFEPAK®20

Performance Inspection Procedure (PIP)

Page 1 of 61

LIFEPAK®20 MONITOR/DEFIBRILLATOR

_______________________________________________________

Performance Inspection Procedure (PIP)

LIFEPAK®20

Performance Inspection Procedure (PIP)

Page 2 of 61

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)

Page 3 of 61

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)

Page 4 of 61

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)

Page 6 of 61

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:

ohms

±1%

Accuracy:

+/- 2%, non-

inductive

Waveforms:

eous

12-lead output

Rates:

30 bpm, 120 bpm, with rate

accuracy

of ±

Amplitude: 1

5%,

based

on Lead

ECG performance:

Amplitudes of LeadII and

Leads

V1-V6are equivalent. LeadI = 70%

amplitude of Lead

II.

Sine

wave:

10 Hz

1 mV± 2%,

based

Lead

Fluke® Biomedical Impulse

7000DP with

QUIK-COMBO

adapter

accessory

16/7 D/P

ADPT10

4**

Safety

Analyzer

ac rms to 264

ac rms mains voltage

Current range:

0-1999 A

Current accuracy:

5% of

rea

or 1 digit

(whichever

is greater)

Fluke Biomedical ESA612*

Decade resistance

box

0 to 9 M

resistance

box

Resolution:1 ;

accuracy:

IET RS-200

Resistance Su

bstit

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)

Page 7 of 61

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)

Page 8 of 61

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)

Page 9 of 61

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)

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

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