GE CAM-14 User manual

CAM-14 Acquisition Module
field service manual
PN 421315-001
Revision A
T-2
field service manual
PN 421315-001 Revision A
3
2
1
NOTE
Due to continuing product innovation, specifications in this manual are subject to change without notice.
MD1320-005
Copyright GE Marquette Medical Systems, Inc. 1998. All rights reserved.
Trademarked names appear throughout this document. Rather than list the names and entities that own the trademarks or in sert a trademark s y mbol with each mentio n of the trademarked n am e, the publisher stat es that it is using the names only for editorial purposes and to the benefit of the trademark owner with no intention of improperly using the tra d emark.
900 SC, ACCUSKETCH, AccuVision, APEX , AQUA-KNOT, ARCHIVIST, Autoseq, BABY MAC, C Qwik Connect, CardioServ, CardioSmart, CardioSys, CardioWindow, CASE, CD TELEMETRY, CENTRA, CHART GUARD, CINE 35, COROLAN, CORO, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STO RE , INTE LLIMOTION, LASER SXP, MAC, MAC­LAB, MACTRODE, MARQUETTE, MARQUETTE MAC, MARQUETTE MEDICAL SYSTEMS, MARQUETTE UNITY NETWORK, MARS, MAX, MEDITEL, MEI, MEI in the circle logo, MEMOPORT, MEMOPORT C, MINISTORE, MINNOWS, Monarch 8000, MULTI-LINK, MULTISCR IPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT, OnlineABG, OXYMONITOR, Pres-R-Cuff, PRESSURE-SCRIBE, QMI, QS, Quantitative Medicine, Quantitative Sentinel, RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOL ARV IEW, Spectra 400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM KNOB, Trimline, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic, VariCath, VARIDEX, VAS, Vision Care Filter, are trademarks of GE Marquette Medical Systems, Inc., registered in the United States Patent and Trademark Office.
2SL, 15SL, Access, AccuSpeak, ADVANTAGE, BAM, BODYTRODE, Cardiomatic, CardioSpeak, CD TELEMETRY®
-LAN, CENTRALSCOPE, Corolation, DASH, EK-Pro, EDIC, Event-Link Cumulus, Event-Link Cirrus, Event-Lin k Nimbus, HI-RES, ICMMS, IMAGE VAULT, IMPACT.wf, INTER-LEAD, IQA, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE® RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, OCTANET, O2 SENSOR, OMRS, PHi-Res, Premium, Prism, QUIK CONNECT V. QUICK CONNECT, QT Guard, RAC, SMARTLOOK, SMART-PAC, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, Walkmom are trademarks of GE Marquette Medical Systems, Inc.
T-2
CAM-14 Acquisition Module
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18 December 1998
Revision A
Contents
1 Introduction ................................................. 1-1
Manual Information .................................................................. 1-3
Revision History ................................................................................. 1-3
Manual Purpose ................................................................................. 1-3
Intended Audience ............................................................................. 1-3
Safety Information .................................................................... 1-4
Definitions .......................................................................................... 1-4
Messages ........................................................................................... 1-4
Responsibility of the Manufacturer .................................................... 1-5
Intended Use ...................................................................................... 1-5
General .............................................................................................. 1-5
Equipment Symbols ........................................................................... 1-6
Service Information .................................................................. 1-7
Service Requirements ........................................................................ 1-7
Equipment Identification .................................................................... 1-7
2 Equipment Overview ...................................... 2-1
Technical Characteristics ........................................................... 2-3
General Description ......................... ....................................... ........... 2-3
Power Requirements ......................................................................... 2-4
Operation ...................................................................... 2-5
Operating Controls ............................................................................. 2-5
Leadwire Attachments ....................................................................... 2-5
Leadwire Adapters ................................................................ 2-6
Lead Configurations ............................................................. 2-7
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3 Maintenance ................................................ 3-1
Recommended Maintenance ....................................................... 3-3
General .............................................................................................. 3-3
Cleaning ............................................................................................. 3-3
Exterior Surfaces .................................................................. 3-3
Electrodes ............................................................................. 3-3
Visual Checking ................................................................................. 3-4
Built-In Diagnostic Tests .................................................................... 3-4
Domestic Electrical Safety Tests ................................................... 3-5
AC Line Voltage Test .......................................................................... 3-5
120 VAC, 50/60 Hz ...............................................................3-5
240 VAC, 50/60 Hz ...............................................................3-5
Leakage Tests .................................................................................... 3-6
Leakage Test Diagrams ...................................................................... 3-7
Test #1 Ground-wire-leakage-to-ground ........................................... 3-7
Test #2 Chassis-leakage-to-ground ................................................... 3-7
Test #3 Patient-cable-leakage-to-ground ......................................... .3-8
Test #4 Patient-cable-leakage-into-patient Leads-from 120 VAC ...... 3-8
Ground Continuity 3-9
Disassembly ..................................................................... 3-10
4 Parts Lists and Drawings ................................. 4-1
Ordering Parts ...................................................................... 4-3
Introduction ....................................................................................... 4-3
900995-001A Acquisition Module Assembly ................................. 4-4
420101-001B 14 Leadwire Kit .................................................. 4-7
417483-9XXA Leadwire, Multi-Link, Universal ............................. 4-8
900179-201 Leadwire Adapter Kit - Banana .............................. 4-10
900179-202 Leadwire Adapter Kit - Mactrode .................... .... .... 4-11
900179-203 Leadwire Adapter Kit - Grabber .............................. 4-12
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5 PCB Assemblies ........................................... 5-1
8001280-001A Data Acquisition Module ....................................... 5-3
SD8001280-001ASchematic, Main Board .................... ... .... ............. 5-8
Appendix A: Abbreviations ...............................A-1
Standard Abbreviations .............................................................. A-3
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1 Introduction

Manual Information ..................................................................... 3
Revision History ..................................................................................... 3
Manual Purpose ..................................................................................... 3
Intended Audience ................................................................................. 3
Safety Information ....................................................................... 4
Definitions .............................................................................................. 4
Messages ............................................................................................... 4
Responsibility of the Manufacturer ........................................................ 5
Intended Use .......................................................................................... 5
General .................................................................................................. 5
Equipment Symbols ............................................................................... 6
Service Information ..................................................................... 7
Service Requirements ............................................................................ 7
Equipment Identification ........................................................................ 7
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1-2
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Manual Information

Introduction: Manual Information

Revision History

Manual Purpose

Each page of the document has the document part number followed by a revision letter located at the bottom of the page. This letter identifies
the document’s update level. The latest letter of the alphabet corresponds to the most current revision of t he document.
The revision history of this document is summarized in the table below.
Table 2-1. Revision History
Revision Date Comment
A 18 December 1998 Initial release.
This manual suppl ies technical infor mation for service representative and technical personnel so they can maintain the equipme nt to the assembly level. Use it as a guide for maintenance and electrical repairs considered field repairable. Where necessary the manual identifies additional sources of re levant information and or t echnical assistance.
See the host operator manual for instructions necessary to operate the equipment safely in accordance with its function and intended use.

Intended Audience

This manual is inten ded for the person who uses, maintains, or troubleshoots this equipment.
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Safety Information

Definitions

Messages

DANGER
Do NOT use in the presence of flammable anesthetics.
DANGER
Indicates an imminently hazardous situation which, if not avoided, WILL result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not avoided, COULD result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided may result in minor or moderate injury.
Additional safety messages may be found throughout this manual that provide appropria te safe operation inform ation.
WARNING
Keep the conductive parts of lead electrodes and associated parts
M15287-1B
away from other conductive parts, including earth.
M15287-4C
WARNING
Do NOT contact unit or patient during defibrillation.
CAUTION
This equipment contains no user serviceable parts. Refer servicing to qualified service personnel.
M15287-8C
M15287-38A
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
M15287-17A
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Introduction: Safety Information
Responsibility of the
Manufacturer

Intended Use

General

GE Marquette Medical Sy stems is responsible for th e effects of safety, reliability, and perfor mance only if:
Assembly operations, extensions, readjustments, modifications,
or repairs are carried out by persons authorized by Marquette.
The electrical installation of the relevant room complies with
the requirements of the appropriate regulations.
The equipment is used in accordance with the instructions for use.
The CAM-14 acquistion module is intended to acquire analog ECG signal, digitize it and t ransmit the signal t o a host unit. The circuitry is designed to protect the host unit against the effects of cardiac defibrillator discharge to ensure recovery.
This device is inten ded for use u nder t he di rect supervi sion of a lice nsed health care pr actitioner.
This equipment is protected against the effects of cardiac defibrillator discharge to ensure re covery, as required by test standards.
This equipment will not cause abnormal operation of the patient’s cardiac pacemaker or other electrical stimulator.
This device uses a computerized ECG analysis program which can be used as a tool in ECG tracing interpretation. This com puterized interpretatio n is only significant when used in co njunction with clinical findings. All computer-generated tracings should be overread by a qualified physicia n.
To ensure accuracy, use only computer-generated tracings and not the display for physician int erpretation.
To ensure pati en t safety, use only parts an d a cce ssories manufact ured or recommended by GE GE Marquette Medical Systems.
Contact GE Marquette Medical Systems for information before connecting any device s to this equipment that a re not recommended in this manual.
If the installation of this equipment, in the USA, will use 240 V rather than 120 V, the source must be a center-tapped, 240 V, single-phase circuit.
Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 601-1-1 medical electrical systems standard.
The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of
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Introduction: Safety Information
safety of the resulting sy st em. Consideration relating to the choice shall include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has
been performed in accordance to the appropriate IEC 601-1 and/or IEC 601-1-1 harmonized national standard.

Equipment Symbols

M13932
The following symbols appear on the equipment.
Type BF equipment. Type BF equipment is suitable for intentional external and internal application to the patient, excluding a direct conductive connection to the
patient’s heart. Type BF equipment has an F-type applied part. The paddles indicate that the equipment is defibrillator proof.
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Service Information

Introduction: Service Information

Service Requirements

Equipment Identification

Refer equipment servicing to GE Marque tte Medical Systems’ authorized service per sonnel only. Any unauthorize d attempt to repair equipment under warranty voids that warranty.
It is the user’s responsibility to report the need for service to GE Marquette Medical Systems or to one of their authorized agents.
Every GE Marquette Medical Systems device has a unique s erial numbe r for identification. The serial number appears on the product label on the base of each unit.
XXXXXXXXX
XXXXXXXX XXXXXXX XXXXXXX XXX
XXXXXXXXX XX XXXX XX XXXXX
J6XX0415FXX
I
Table 2-2. Equipmen t Identifications
Item Name Description
G
H
F
D
E
A B
C
MD1113-022B
A name of device AM-114 Acquisition Module B manufacturer GE Marquette Medical Systems, Inc. C serial number Unique identifier D device characteristics One or two letters that further describe the unit, for example: P = prototype not
conforming to marketing specification; R = refurbished equipment; S = special
product documented under Specials part numbers; U = upgraded unit E division F = Cardiology G = Monitoring J = GW Labs F product sequence number Manufacturing number (of total units manufactured) G product code Two-character product descriptor MF = CAM-14 Acquisition Module H year manufactured 7 = 1997, 8= 1998, 9= 1999, (and so on) I month manufactured A = January, B = February, C = March, D = April, E = May, F = June, G = July,
H = August, J = September, K = October, L = November, M = December
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2 Equipment Overview

Technical Characteristics .............................................................. 3
General Description ......................... ....................................... ............... 3
Power Requirements ............................................................................. 4
Operation ................................................................................. 5
Operating Controls ................................................................................. 5
Leadwire Attachments ........................................................................... 5
Leadwire Adapters ....................................................................6
Lead Configurations .................................................................7
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Technical Characteristics

Equipment Overview: Technical Characteristics

General Description

The acquisition module performs high resolution ECG data acquisition for use with host equipment (resting ECG analysis systems and exercise systems). The acquisition m o du le has the following feature s:
ac leadfail bias,
l ead off dete ct ion,
4000 Hz sampling rate,
patient isolation,
software updates via floppy diskette, and
Hi-Res analysis on 14-lead units
fu nc ti on key cont rol of host equi pme nt fu nc ti ons
The acquisition module provides patient electrical isolation for the host
equipment. The minute ECG s ignal s from th e pati ent’ s skin ar e rec eived by the electrodes and sent to the acquisition module via leadwires. The acquisition module then amplifies, digitizes, and performs some processing on the signals.
This whole process is contro lle d by a microprocessor in the acquisition module. The acquisition module then sends the serial, digitized, ECG data to the host equipment in 16 bit “words”. The host equipment communicates to the acquisition module using this same serial line.
Table 2-1. Safety
Item Description
Certification CE Marking for Council Directive 93/42/EEC Type of Protection Against Electrical
Not applicable
Shock Degree of Protection Against Ingress
Ordinary
of Liquids Handling of Disposable Supplies and
Other Consum ables
Use only as manufactured or recommended by Marquette.
Follow manufacturer’s instructions for use for disposable/consumable product.
Follow local environmental guidelines concerning the disposal of hazardous
materials (e.g. lead acid batteries) Patient Mode of Operation Continuous Patient Leakage Current less than 10µA Degree of Protection Against Electrical
type BF applied parts
Shock
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Table 2-1. Safety (Continued)
Item Description
Maintenance Frequency Recommended user daily visual inspection and cleaning.
Recommended six-month routine maintenance checks and test procedures
performed by qualified technical personnel. Repair Guidelines Calibration instructions, equi pment descriptions, and all other service informati on to
repair those parts of the equipment designated as field repairable by qualified technical personnel is available in the service manual. Upon request, GE Marquette Medical Systems will provide circuit diagrams and component parts lists for printed circuit boards deemed repairable by qualified technical personnel.
Table 2-2. Environmental
Item Description
Operating Instructions
Temperature 0°C to 50°C (32°F to 154°F)
Relative Humidity 20% to 95% noncondensing Atmosphere Pressure 70 to 106 KPa (PRELIMINARY pending final testing)
Storage Conditions
Temperature –20°C to 60°C (–4°F to 172°F) Relative Humidity 5% to 95% noncondensing Atmosphere Pressure 50 to 106 KPa (PRELIMINARY pending final testing)

Power Requirements

The acquisition module draws it s power, 12 V dc, from the host unit.
(See the host equipment’s field service manual for the host equ ipment’s power requirements.) The acquisition module provides the patient electrical isolation for the host equipment.
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Operation

Equipment Overview: Operation

Operating Controls

Leadwire Attachments

There are three controls on the acquisition module that are programmed by the host to record an ECG, record a rhythm, or stop the
writer. See the host equipment operator’s manual for the for specific information on using th e a cquisition module.
2 31
MD1320-002
The leadwires are shown with 2 ends. The figure below shows how to use both ends of the leadwires. There are various options for leadwire adapters, the 4 mm pin, stress grabbe r, or MACTR ODE cli p. See cha pte r 5, “Parts Lists and Drawing s” for part numbers.
Flat Surface
Step 1
Step 3
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Step 4
MD1320-003B
Equipment Overview: Operation
Leadwire Adapters
The acquisition module has universal leadwires which can be made into any lead of 3 basic types by using the adapters on the ends as shown in the figure below. The acquisition module leadwire adapters have a
variety of configuration s as shown below. (See chapter 4, “Parts Lists and Drawings” for part numbers for the various individual leadwire adapters.)
4 mm Pin
Stress Grabber
MACTRODE Clip
Universal Leadwire End
MD1287-004A
Refer to the figure on the next page for various labels that are affixed to the acquisition mod ule for these configurations.
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Lead Configurations
10 Lead AHA
14 Lead AHA
The various lead configurations are shown in the figure below. The acquisition module may be configured in any one of these ways. See
chapter 5, “Parts Lists and Drawings” for part numbers.
N R C1 C2 C3 A1 A2 A3 A4 C4 C5 C6 L F
2 31
acquisition module
RL RA V1 V2 V3 V4 V5 V6 LA LL
HE MRL RA V1 V2 V3 I V4 V5 V6 LA LL
14 Lead AHA Pediatric
10 Lead IEC
14 Lead IEC
14 Lead IEC Pediatric
14 Lead AHA AUX
14 Lead IEC AUX
RL RA V1 V2 V3
V3R V4R
V7 V4 V5 V6 LA LL
N R C1 C2 C3 C4 C5 C6 L F
N R C1 C2 C3 I C4 C5 C6 L F
N R C1 C2 C3
RL RA V1 V2 V3 A1 A2
HE
C3R C4R
C7 C4 C5 C6 L F
A3 A4MV4 V5 V6 LA LL
N R C1 C2 C3 A1 A2 A3 A4 C4 C5 C6 L F
MD1320-004
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3 Maintenance

Recommended Maintenance .......................................................... 3
General .................................................................................................. 3
Cleaning 3
Exterior Surfaces ......................................................................3
Electrodes .................................................................................3
Visual Checking 4 Built-In Diagnostic Tests 4
Domestic Electrical Safety Tests ...................................................... 5
AC Line Voltage Test .............................................................................. 5
120 VAC, 50/60 Hz ...................................................................5
240 VAC, 50/60 Hz ...................................................................5
Leakage Tests 6 Leakage Test Diagrams 7
Test #1 Ground-wire-leakage-to-ground ...........................................7
Test #2 Chassis-leakage-to-ground .............................................. .....7
Test #3 Patient-cable-leakage-to-ground ..........................................8
Test #4 Patient-cable-leakage-into-patient Leads-from 120 VAC .......8
Ground Continuity 9
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Disassembly ............................................................................ 10
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Recommended Maintenance

Maintenance: Recommended Maintenance

General

Cleaning

Other than daily cleaning and occasional visual checking, the acquisition module requires no maintena nce.
Only qualified service personnel should attemp t repairing components and assemblies int ernal to the acquis ition module. For servic e and repair, return the acquisition module to the factory for 48-hour turn
around service. Call Tech Support for assistance. (See the “How to Reach Us” page in the front of the manual.)
NOTE
Unless you have an Equipment Maintenance Contract, GE Marquette Medical Systems does not in any manner assume the responsibility for performing the recommended maintenance procedures. The sole responsibility rests with the individual or institution using the equipment. GE Marquette Medical Systems service personnel may, at their discretion, follow the procedures provided in this manual as a guide during visits to the equipment site.
Exterior Surfaces
Electrodes
Disconnect the acquisition module interface cab le from the host equipment.
Use a soft cloth moistened with water and a mild detergent.
Wipe the exterior of the unit, the leadwires, and the acquisition module interface cable with the damp cloth. Dry all surfaces with a clean, soft cloth or paper towel.
DO NOT allow any excess water to get inside the acquisition
module or onto the leadwires or interface cable.
Do not immerse acquisition module in water.
Do not use alcohols, organic solvents, or abrasive cleaning
agents.
After each use, wipe reusable electrodes with a tissue or damp
cloth to clean them of electrode paste. At the end of each day, wash reusable electr od es thoroughly with soap and water and dried.
For suction electrodes, use a toothbrush to clean out the cups.
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