Medtronic Physio-Control Lifepak 12 Service Manual

LIFEPAK

12

defibrillator/monitor series

®

Service Manual

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LIFEPAK 12 defibrillator/monitor series Table of Contents

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Preface

Modes of
Operation

Preventive
Maintenance

Safety

Performance
Inspection

Battery
Maintenance

Device
Description

Instrument
Calibration

Replacement
Procedures

Operating
Instructions

Trouble­shooting

Parts Lists and
Assembly
Diagrams

Index

2

Title Page

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LIFEPAK 12 defibrillator/monitor series Section Contents

Preface

This Service Manual describes how to maintain, test, troubleshoot, and repair
the LIFEPAK 12 defibrillator/monitor. A separate publication, the LIFEPAK 12

defibrillator/monitor series Operating Instructions, is for use by physicians,

clinicians, and emergency care providers. The Operating Instructions provide
step-by-step instructions as well as operator-level testing and maintenance.

Note:

message, or screen overlay appears as small caps. For example,
control and

This section covers the following topics:

Hyperlinks appear in Blue Text. Text that indicates a control, menu,

ADVISORY

SETUP

Menu.

Trademarks
Service Personnel Qualifications
Contacting Medtronic Physio-Control
Responsibility for Information
Device Tracking
Service Information
Recycling Information
Warranty
Configuration Information
Glossary

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LIFEPAK 12 defibrillator/monitor series Preface

Trademarks

PHYSIO-CONTROL, LIFEPAK, FASTPAK, and DERMA JEL are registered trademarks of
Medtronic Physio-Control Corp.
QUIK-COMBO, CODE SUMMARY, CODE-STAT Suite, QUIK-VIEW, DATA TRANSFER,
REDI-PAK, FAST-PATCH, PARTSLINE, Shock Advisory System, and the Medtronic
Physio-Control 3D Biphasic technology trademark are trademarks of Medtronic
Physio-Control Corp.
Medtronic is a registered trademark of Medtronic, Inc.
MICROSOFT and WINDOWS are registered trademarks of Microsoft Corporation in the US
and/or other countries.
Pentium is a trademark of Intel Corporation.
Adobe and Acrobat are trademarks of Adobe Systems Incorporated.
12SL and Muse CV are trademarks of Marquette Medical Systems.
Oridion is a protected trademark and Microstream and FilterLine are trademarks of Oridion
Medical Ltd.
C-LOCK is a registered trademark of Nellcor Puritan Bennett.
Tektronix is a registered trademark of Tektronix Incorporated.
BIO-TEK is a registered trademark of Bio-Tek Instruments, Inc. QED is a trademark of Bio­Tek Instruments, Inc.
Black Box is a registered trademark of Black Box Corporation.
3Com and Megahertz are registered trademarks of 3Com Corporation.
Motorola is a registered trademark of Motorola, Inc.
PC Card is a trademark of the Personal Computer Memory Card International Association.
Duracell is a registered trademark of Duracell, a wholly-owned subsidiary of The Gillette Co.
Specifications are subject to change without notice.

© 1998–2001 Medtronic Physio-Control Corp. All rights reserved.

4

PN 3010013-015

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LIFEPAK 12 defibrillator/monitor series Preface

Service Personnel Qualifications

Technicians who service the device must be properly qualified and thoroughly
familiar with the operation of the LIFEPAK 12 defibrillator/monitor. Technicians
must meet at least one of the following requirements (or the equivalent):

■

Associate of Applied Science, with an emphasis in biomedical electronics

■

Certificate of Technical Training, with an emphasis in biomedical electronics

■

Equivalent biomedical electronics experience

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LIFEPAK 12 defibrillator/monitor series Preface

Contacting Medtronic Physio-Control

Medtronic Physio-Control

11811 Willows Road Northeast
Post Office Box 97006
Redmond, WA 98073-9706 USA
Telephone: [phone]
Toll Free (USA only): 1.800.442.1142
Fax: [phone]

Internet: www.physiocontrol.com

www.medtronic.com

Europe

Medtronic Physio-Control
Rte. Du Molliau 31
1131 Tolochenaz
Switzerland
Telephone: [phone]
Fax: [phone]

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LIFEPAK 12 defibrillator/monitor series Preface

Responsibility for Information

This Service Manual describes the methods required to maintain, test, and
repair the LIFEPAK 12 defibrillator/monitor. This manual does not cover
operation of the LIFEPAK 12 defibrillator/monitor. Qualified service personnel
must consult both the LIFEPAK 12 defibrillator/monitor series Operating

Instructions and the LIFEPAK 12 defibrillator/monitor series Service Manual to

obtain a complete understanding of the use and maintenance of the device.
It is the responsibility of our customers to ensure that the appropriate person(s)

within their organization have access to the information in this Service Manual,
including any warnings and cautions used throughout the LIFEPAK 12
defibrillator/monitor series Service Manual.

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LIFEPAK 12 defibrillator/monitor series Preface

Device Tracking

USA only, including US government-owned devices:
The Food and Drug Administration requires defibrillator manufacturers and

distributors to track the location of defibrillators. If your defibrillator has been
sold, donated, lost, stolen, exported, or destroyed, or if it was not obtained
directly from Medtronic Physio-Control, please notify Medtronic Physio-Control
at 1.800.442.1142, extension 4530.

General information related to device tracking:
It is important to maintain accurate records of defibrillator location within your

facility or system. Maintenance of such records eases the process of locating
defibrillators should it be necessary to modify them. Defibrillators should be
tracked by both the manufacturer’s part and serial number. Internal asset or
tracking numbers may also be useful in maintaining adequate control of
defibrillators.

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LIFEPAK 12 defibrillator/monitor series Preface

Service Information

Before attempting to clean or repair any assembly in this device, the technician
should be familiar with the information provided in the Preventive Maintenance
section.

A qualified technician should inspect any defibrillator that has been dropped,
damaged, or abused to verify that the device is operating within performance
standards listed in the Performance Inspection Procedure (PIP), and that the
leakage current values are acceptable.

Replacement procedures for the LIFEPAK 12 defibrillator/monitor are limited to
those items accessible at the final assembly level. Replacements and
adjustments must be made by service personnel qualified by appropriate
training and experience. Replacements at the final assembly level simplify repair
and servicing procedures, and help ensure correct device operation and
calibration.

To obtain Medtronic Physio-Control service and maintenance for your
LIFEPAK 12 defibrillator/monitor, contact your local service or sales
representative. In the USA, call Medtronic Physio-Control Technical Services at

1.800.442.1142. Outside the USA, contact your local Medtronic Physio-Control
representative.

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LIFEPAK 12 defibrillator/monitor series Preface

Recycling Information

Recycle the device at the end of its useful life.

■

Recycling Assistance – The device should be recycled according to national
and local regulations. Contact your local Medtronic Physio-Control
representative for assistance.

■

Preparation – The device should be clean and contaminant-free prior to
being recycled.

■

Recycling of Disposable Electrodes – After using disposable electrodes,
follow your local clinical procedures for recycling.

■

Recycling of Batteries – The device uses rechargeable FASTPAK,
FASTPAK 2 NiCd (Nickel-Cadmium) and LIFEPAK NiCd, and LIFEPAK SLA
(sealed lead-acid) batteries. Follow local guidelines and instructions given in
this Service Manual for discarding/recycling batteries.

■

Packaging – Save or recycle packaging materials.

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LIFEPAK 12 defibrillator/monitor series Preface

Warranty

Refer to the Warranty statement included in the Operating Instructions –

Maintaining the Equipment.

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LIFEPAK 12 defibrillator/monitor series Preface

Configuration Information

This Service Manual covers existing LIFEPAK 12 defibrillator/monitor series
devices and options through the following revisions:

■

LIFEPAK 12 Monophasic Basic Device with ECG

■

LIFEPAK 12 Biphasic Basic Device with ECG

■

Pacing Option

■

SpO2 Option

■

12-Lead Option

■

NIBP Monitor Option

■

EtCO2 Option

■

Fax/Data Communication Option

■

ElectroLuminescent (EL) Display Option

■

Invasive Pressure Option

■

Vital Signs Trending Option

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LIFEPAK 12 defibrillator/monitor series Preface

Glossary Page 1 of 3

The following are definitions of terms used throughout this Service Manual.

■

Automated External Defibrillator (AED) — The LIFEPAK 12 defibrillator/
monitor uses an ECG analysis Shock Advisory System (SAS) to advise the
device operator if it detects a shockable or nonshockable rhythm. For more
information about CPSS and SAS, see

Operating Instructions – Shock

the

Advisory System

■

Biphasic — Property of the shock waveform generated by the LIFEPAK 12
biphasic defibrillator/monitor. The biphasic waveform is characterized by a
positive current phase followed by a reverse current phase of shorter
duration and decreased magnitude. The waveform pulse characteristic is
biphasic truncated exponential (BTE).

■

CODE SUMMARY™ Report — A summary report that includes the ECG
segments associated with key events such as analysis or shock. See the

Operating Instructions — Data Management for a sample CODE

SUMMARY Report.

13

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Glossary Page 2 of 3

■

Continuous Patient Surveillance System (CPSS) — A feature that monitors
the patient ECG in

LEADS

PADDLES

or

for a potentially shockable rhythm.

CPSS is active when the front panel

VF/VT ALARM

the

is selected after pressing the

ADVISORY

indicator is on (AED Mode) or

ALARMS

control (Manual Mode).
The CPSS operates in conjunction with the Shock Advisory System (SAS).
For more information about CPSS and SAS, see

Instructions — Shock Advisory System

■

Edmark — Property of the shock waveform generated by the LIFEPAK 12

.

Operating

the

Monophasic defibrillator/monitor. The Edmark pulse characteristic is
monophasic damped sinusoid (MDS) per AAMI DF2-1989 3.2.1.5.1.

■

End-Tidal Carbon Dioxide (EtCO2) — A noninvasive capnometer that
monitors EtCO2, FiCO2, and respiration rate.

■

Event Log Summary — A report summarizing important events for a
particular patient record; part of the CODE SUMMARY Report.

■

FAST-PATCH™ disposable defibrillation/ECG electrodes — An electrode
system that allows delivery of defibrillation therapy to the patient.

■

Monophasic — See Edmark.

■

Noninvasive Blood Pressure (NIBP) — An optional meter that checks
systolic, diastolic, and mean arterial blood pressure, along with pulse rate.

■

QUIK-COMBO™ pacing/defibrillation/ECG electrodes — An electrode

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system that allows delivery of pacing and defibrillation therapy to the patient.

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LIFEPAK 12 defibrillator/monitor series Preface

Glossary Page 3 of 3

■

QUIK-COMBO patient simulator — A combination lead tester/patient cardiac
rhythm simulator. The simulator is designed for use in training clinical
personnel in the operation of the LIFEPAK 12 defibrillator/monitor.

■

REDI-PAK™ preconnect system — A variant of the QUIK-COMBO pacing/
defibrillation/ECG electrodes system. The system allows QUIK-COMBO
pacing/defibrillation/ECG electrode cable connection without removing the
electrodes from their air-tight sealed pouch until needed.

■

Shock Advisory System (SAS) — A computerized ECG analysis system for
use in the detection of a shockable rhythm. For more information about
CPSS and SAS, see

System

■

SpO2 — A noninvasive pulse oximeter that checks the saturation of oxygen

.

Operating Instructions — Shock Advisory

the

in arterial blood.

■

Test Load — A device that provides an external defibrillation test load for the
defibrillator/monitor. The test load connects to the patient connector on the
device.

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LIFEPAK 12 defibrillator/monitor series Preface

Acronyms Page 1 of 4

The following is a list of acronyms and abbreviations used in this manual.

Term Description

AAMI Association for the Advancement of Medical Instrumentation
ADC Analog-to-Digital Conversion
AED Automated External Defibrillator
A/H Amp/Hours: A measure of battery capacity
AHA American Heart Association
AMI Acute Myocardial Infarction
ANSI American National Standards Institute
ASIC Application-Specific Integrated Circuit
BTE Biphasic Truncated Exponential
BF Electrically isolated, external body connection
BPM Beats Per Minute
CF Electrically isolated, direct cardiac connection
CPR Cardiopulmonary Resuscitation
CPU Central Processing Unit
CPSS Continuous Patient Surveillance System
DDE Disposable Defibrillation Electrodes

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DSP Digital Signal Processor

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LIFEPAK 12 defibrillator/monitor series Preface

Acronyms Page 2 of 4

.

Term Description

DUART Dual Universal Asynchronous Receiver/Transmitter
DMM Digital Multimeter
ECG Electrocardiogram
EMS Emergency Medical Service
ESCC Energy Storage Capacitor Charger
ESD Electrostatic Discharge
ESU Electrosurgical Unit
EtCO2 End-Tidal Carbon Dioxide
FiCO2 Inspired Carbon Dioxide
HR Heart Rate
IEC International Electrical Commission
IP Invasive Pressure
LCD Liquid Crystal Display
LED Light Emitting Diode
MDS Monophasic Damped Sinusoidal
MMHg Millimeters of Mercury
NIBP Noninvasive Blood Pressure

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NiCd Nickel-Cadmium (battery)

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LIFEPAK 12 defibrillator/monitor series Preface

Acronyms Page 3 of 4

Term Description

NHAAP National Heart Attack Alert Program
NSR Normal Sinus Rhythm
OEM Original Equipment Manufacturer
RR Respiration Rate
PC Personal Computer
PCB Printed Circuit Board
PCMCIA Personal Computer Memory Card International Association
PIP Performance Inspection Procedure
PPM Pulses Per Minute
QRS Refers to portions of the ECG waveform
RISC Reduced Instruction Set Computer
RTC/

NVRAM
RTS Radio Transparent System
SAS Shock Advisory System
SLA Sealed Lead-Acid (battery)
SpO2 Pulse Oximeter reading (saturation of oxygen in arterial blood)

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SSD Static-Sensitive Device

Real Time Clock/Non-Volatile Random-Access Memory

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LIFEPAK 12 defibrillator/monitor series Preface

Acronyms Page 4 of 4

Term Description

TCP Test and Calibration Procedure
UUT Unit Under Test
VF Ventricular Fibrillation
VT Ventricular Tachycardia
µA MicroAmpere

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LIFEPAK 12 defibrillator/monitor series Section Contents

Safety

The Safety section describes the general safety conventions, terms, and
symbols used in this Service Manual or on the LIFEPAK 12 defibrillator/monitor
front and rear panels. This information is intended to alert service personnel to
recommended precautions in the care, use, and handling of this specialized
medical device.

Terms

General Warnings and Cautions

Symbols

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LIFEPAK 12 defibrillator/monitor series Safety

Ter ms

The following terms are used in this Service Manual or on the various
configurations of the LIFEPAK 12 defibrillator/monitor. Familiarize yourself with
their definitions and significance.

Danger: Immediate hazards that will result in serious personal injury or death.
Warning: Hazards or unsafe practices that could result in serious personal injury

or death.
Caution: Hazards or unsafe practices that could result in device or property

damage.

Note:

operation; additional information or explanation concerning the subject under
discussion.

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Points of particular interest for more efficient or convenient device

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LIFEPAK 12 defibrillator/monitor series Safety

General Warnings and Cautions Page 1 of 2

The following are general warnings and cautions. Keep these warnings and
cautions in mind when working with the LIFEPAK 12 defibrillator/monitor. More
specific warnings and cautions appear throughout this Service Manual and the
LIFEPAK 12 defibrillator/monitor Operating Instructions.

WARNINGS!

Possible fire or explosion. Do not service this device in the presence of

flammable gases, anesthetics, or oxygen sources.

Shock or fire hazard. Do not immerse any portion of this device in water or

other fluids. Avoid spilling any fluids on the device or accessories. If the
device is ever immersed in water or other fluids, remove the batteries and
disconnect input power source from any attached AC or DC Power Adapter
until the device can be serviced.

Patient hazard. Do not mount the device directly above patient. Place the

device in a location where it cannot harm the patient should it fall from its
shelf or other mount.

Shock or fire hazard. Equipment or accessories improperly interconnected

to each other can be a source of ignition or cause a shock. Make sure that
all equipment is interconnected safely.

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General Warnings and Cautions Page 2 of 2

WARNING!

Shock hazard. Servicing of this device must be performed by properly

trained individuals. This device may retain potentially lethal charges
accessible inside the device at any time–even when off. Follow procedures
carefully for discharging the A15 Energy Storage Capacitor and the Pacing
Capacitor on the A04 Therapy PCB.

CAUTIONS!

Possible equipment damage. This device may be damaged by mechanical

or physical abuse such as immersion in water or dropping. If the device
has been abused, remove it from use and contact qualified service
personnel.

Possible device damage. To help prevent component damage, do not

mount the device near vibration sources such as engine struts or landing
gear.

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LIFEPAK 12 defibrillator/monitor series Safety

Symbols Page 1 of 7

The following list includes symbols that may be used in this Service
Manual or on various configurations of the LIFEPAK 12 defibrillator/monitor
and accessories. Some symbols may not be relevant to your device or used in
every country.

Defibrillation-proof type CF terminal

Defibrillation protected, type BF patient connection

Attention, consult accompanying documents

Warning, high voltage

Biphasic defibrillation shock

Type BF patient connection

Static-sensitive device (SSD)

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LIFEPAK 12 defibrillator/monitor series Safety

Symbols Page 2 of 7

Safety Class II equipment (reinforced insulation)

Type B equipment

Fuse

Positive terminal

Negative terminal

YYWW

LOT

Lot number (batch code)

Use by expiration date

REF

YYYY

Reorder number (catalog number)

Date of manufacture

Single use only

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Indoor use only

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LIFEPAK 12 defibrillator/monitor series Safety

Symbols Page 3 of 7

Alarm on

Alarm off

VT alarm on

VF/

VF/

VT alarm silenced or suspended

Greater than

Less than

J

Joules

LCD Contrast control

Home screen button

Selector indicator

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LIFEPAK SLA battery

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LIFEPAK 12 defibrillator/monitor series Safety

Symbols Page 4 of 7

1

FASTPAK or LIFEPAK SLA battery in well 1, in use

FASTPAK battery

FASTPAK 2 battery

2

1

FASTPAK or LIFEPAK SLA battery in well 2, not in use

FASTPAK or LIFEPAK SLA battery in well, discharged

LIFEPAK NiCd battery

2

2

1

LIFEPAK NiCd battery in well, fully charged, not in use

LIFEPAK NiCd battery in well, discharged

Heart rate/pulse rate indicator

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LIFEPAK 12 defibrillator/monitor series Safety

Symbols Page 5 of 7

(x)

NRTL/C

Shock count (x) on screen
Marking of conformity according to the Medical Device

Directive 93/42/EEC by notified body TÜV Product Service
GmbH

Canadian Standards Association certification for United
States (Nationally Recognized Test Laboratory) and Canada

DC voltage

AC voltage

On (power: connection to the AC mains)

Off (power: disconnection from the AC mains)

Power on/off

[signal] Input

[signal] Output

or

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Recycle this product

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LIFEPAK 12 defibrillator/monitor series Safety

Symbols Page 6 of 7

Recycle NiCd battery

NiCd

Recycle Nickel Cadmium battery

Pb

Recycle Lead-acid battery
See instructions for recycling instructions

See instructions for disposal procedure

AC to DC adapter

System connector

Telephone line connector

Switch on

Switch off

Pace arrow, noninvasive pacing

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Pace arrow, internal pacing

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LIFEPAK 12 defibrillator/monitor series Safety

Symbols Page 7 of 7

R-wave sense marker

Event marker

CO2 exhaust

CO2

Chassis ground

Recognized component mark for Canada and the United
States

LIFEPAK 12 to LIFEPAK 12 cable

!USA

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For USA audiences only

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