GE MAC 5000 User manual

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T-2 MAC 5000 System — 2000657-024, Revision A
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© GE Medical Systems Information Technologies, 2001. All rights reserved.
12 January 2001

MAC 5000 System — 2000657-024, Revision A CE-1
Marking Information
Compliance
This device bears CE mark CE-0366 or CE-0459
indicating its conformity with the provisions of the
Council Directive 93/42/EEC concerning medical
devices and fulfills the essential requirements of Annex I
of this directive. The product is in radio-interference
protection class A in accordance with EN 55011.
For devices manufactured in the United States, the CE
mark is applied under the authority of Notified Body
GMED (0459).
For devices manufactured in Germany, the CE mark is
applied under the authority of Notified Body VDE
(0366).
The country of manufacture and appropriate Notified
Body can be found on the equipment labeling.
The product complies with the requirements of standard
EN 60601-1-2 “Electromagnetic Compatibility - Medical
Electrical Equipment”.
The safety and effectiveness of this device has been
verified against previously distributed devices. Although
all standards applicable to presently marketed devices
may not be appropriate for prior devices (i.e.
electromagnetic compatibility standards), this devicewill
not impair the safe and effective use of those previously
distributed devices. See user’s information.
Exceptions
There are no exceptions.
0459

MAC 5000 System — 2000657-024, Revision A
CE-2
For Your Notes.

MAC 5000— 2000657-024, Revision A Contents-1
Contents
1 Introduction
Manual Information ...................................................................................... 1-3
Safety Information ........................................................................................ 1-6
Service Information .................................................................................... 1-15
2 Equipment Overview
Equipment Description ................................................................................. 2-3
Getting Started ........................................................................................... 2-12
3 Preparing the Patient
Prepare the Patient’s Skin ........................................................................... 3-3
Apply the Electrodes .................................................................................... 3-4
4 Entering Patient Information
Enter Patient Information ............................................................................. 4-3
Using a Patient Card Reader (Option–Japan only) ..................................... 4-5
Receive Orders From a MUSE CV System (Option) .................................. 4-6
Enter Orders Manually (Option) ................................................................... 4-9

Contents-2 MAC 5000— 2000657-024, Revision A
5 Recording an ECG
Record a 15 Lead, Resting, Pediatric, or Vector Loops ECG ..................... 5-3
Record a Signal Averaged ECG (Options) .................................................. 5-5
Record a Master’s Step Test (Option–Japan only) ..................................... 5-7
Using ACI-TIPI (Option) ............................................................................. 5-10
6 Printing an ECG Report
Print Stored ECG Reports ........................................................................... 6-3
7 Transmitting an ECG
Transmit Stored ECGs by Modem (Option) ................................................ 7-3
Transmit Stored ECGs Locally .................................................................... 7-5
8 Receiving an ECG
Receive ECGs by Modem (Option) ............................................................. 8-3
Receive ECGs Locally ................................................................................. 8-5
Retrieve Confirmed ECGs from a MUSE CV System (Option) ................... 8-7
9 Editing an ECG
Edit Demographic and Interpretive Data ..................................................... 9-3
10 Deleting an ECG
Delete Stored ECGs .................................................................................. 10-3
Delete Stored ECG Orders (Option) .......................................................... 10-5

Contents-3 MAC 5000— 2000657-024, Revision A
11 Completing Other Tasks
Prepare a Disk for Use .............................................................................. 11-3
Eject a Disk From the Drive Slot ............................................................... 11-4
Display Stored ECGs ................................................................................. 11-5
12 Defining the System Setup
To Use the System Setup Function .......................................................... 12-3
Program the System to Automatically do a Task ...................................... 12-5
Define the Basic System Setup ................................................................. 12-9
Define the ECG
Setup ............................................................................. 12-21
Define the Signal Averaged ECG Setup (Option) ................................... 12-32
Master’s Step Setup (Option–Japan Only) .............................................. 12-34
Miscellaneous Setup ................................................................................ 12-35
AMaintenance
General ........................................................................................................ A-3
Inspecting and Cleaning .............................................................................. A-4
Changing the Paper Tray Size .................................................................... A-6
Replacing Paper .......................................................................................... A-7
Storing Paper ............................................................................................... A-8
Maintaining the Battery .............................................................................. A-11
Mounting or Dismounting the Trolley ......................................................... A-15
Replacing Acquisition Module Leadwire Adapters .................................... A-18
Handling a Disk ......................................................................................... A-19
Updating Software ..................................................................................... A-20

Contents-4 MAC 5000— 2000657-024, Revision A
BTroubleshooting
Introduction .................................................................................................. B-3
Equipment Problems ................................................................................... B-4
CEditing Acronyms
Resting ECG Acronyms .............................................................................. C-3
DTechnical Specifications
EReport Formats
Format Description ...................................................................................... E-3
FMasters’ Step Data
Masters’ Step Table ..................................................................................... F-3
ST-T Change ............................................................................................... F-6
Index

MAC 5000 System — 2000657-024, Revision A 1-1
Introduction 1

MAC 5000 System — 2000657-024, Revision A
1-2
For your notes.

Introduction: Manual Information
MAC 5000 System — 2000657-024, Revision A 1-3
Manual Information
Purpose
This manual contains the instructions necessary to
operate the MAC 5000 system in accordance with its
function and intended use.
Intended Audience
This manual is intended for the person who uses,
maintains, or troubleshoots this equipment.
Revision History
Each page of the document has the document part
number and revision letter at the bottom of the page. The
revision letter identifies the document’s update level.
Figure 1-1. Revision History
Letter Date Comment
A12 January 2001 Initial release.

MAC 5000 System — 2000657-024, Revision A
Introduction: Manual Information
1-4
Conventions
Symbol
Styles
Provides additional user information.
Black text Indicates keys on the keyboard, text to be
entered, or hardware items such as buttons
or switches on the equipment.
Italicized
text Indicates software terms that identify menu items, buttons, or options in various windows.
Ctrl+Esc Indicates a keyboard operation. A (+) sign
between the names of two keys indicates
that you must press and hold the first key
while pressing the second key once.
For example, “Press Ctrl+Esc” means to
press and hold down the Ctrl key while
pressing the Esc key.
<Space>Indicates you must press the spacebar.
When instructions are given for typing a
precise text string with one or more spaces,
the point where the spacebar must be
pressed is indicated as: <Space>. The
purpose of the < > brackets is to ensure you
press the spacebar when required.
Enter Indicates you must press the “Enter” or
“Return” key on the keyboard. Do not type
“enter”.

Introduction: Manual Information
MAC 5000 System — 2000657-024, Revision A 1-5
User Instructions
Pictures show you which key to press, screen item to
select, or action you must do to complete a task.
A
B
C
DE
F
G
002A
Figure 1-2. User Instructions
Your Action
APress the f1, f2, f3, f4, f5, or f6 key located below
the screen menu item.
BPress to close a screen menu.
CPress to turn the system power on or off as indicated in
the procedure.
DPress to enter data into the system.
EPress to acquire ECG data and to print or stop printing
writer reports.
FInsert or remove a diskette as indicated by the direction
of the arrow.
GSelect the displayed screen item.

MAC 5000 System — 2000657-024, Revision A
Introduction: Safety Information
1-6
Safety Information
Definitions
The terms danger, warning, and caution are used
throughout this document to point out hazards and to
designate a degree or level of seriousness. Familiarize
yourself with their definitions and significance.
Equipment
The safety statements presented in this chapter refer to
the equipment in general and, in most cases apply to all
aspects of the equipment. There are additional safety
statements in the document’s chapters that are specific to
that chapter.
Danger
Indicates an imminently hazardous
situation which, if not avoided, WILL result
in death or serious injury.
Indicates a potentially hazardous situation
which, if not avoided, COULD result in
death or serious injury.
Indicates a potentially hazardous situation
which, if not avoided may result in minor or
moderate injury.
DANGER
WARNING
CAUTION
M15287-1B
DANGER
Do NOT use in the
presence of flammable
anesthetics.

Introduction: Safety Information
MAC 5000 System — 2000657-024, Revision A 1-7
Warning
Caution
M15287-8C
M15287-8C
M15287-8C
WARNING
WARNING
WARNING
Do NOT contact unit
or patient during
defibrillation.
This is class I
equipment. The
mains plug must be
connected to an
appropriate power
supply.
Operate the unit from
its battery if the
integrity of the
protective earth
conductor is in doubt.
M15287-120A
WARNING
Interpretation hazard. A qualified physician
must overread all computer-generated
tracings. Computerized interpretation is
only significant when used in conjuction
with clinical findings.
M15287-17B
CAUTION
U.S. Federal law restricts this device to
sale by or on the order of a physician.
M15287-17B
CAUTION
This equipment contains no user serviceable
parts. Refer servicing to qualified service
personnel.

MAC 5000 System — 2000657-024, Revision A
Introduction: Safety Information
1-8
Legal Notice
Our equipment contains several fields which can be filled
in before performing an ECG. Some of these fields must
be filled in before performing an exam, some are optional
and therefore left to the user to assess whether they are
needed to perform the exam. A field RACE is one of
these optional fields. It has been acknowledged by the
medical profession as useful to analyze some
pathologies. You should be aware that, in some
jurisdictions, the processing of data revealing an
individual’s racial origin is subject to legal requirements,
such as obtaining the patient’s prior consent. If you elect
to collect this type of data, it is your responsibility to
ensure that you comply with all applicable legal
requirements.

Introduction: Safety Information
MAC 5000 System — 2000657-024, Revision A 1-9
Responsibility of the Manufacturer
GE Medical Systems Information Technologies is
responsible for the effects of safety, reliability, and
performance only if:
n Assembly operations, extensions, readjustments,
modifications, or repairs are carried out by persons
authorized by GE Medical Systems Information
Technologies.
n The electrical installation of the relevant room
complies with the requirements of the appropriate
regulations.
n The equipment is used in accordance with the
instructions for use.
General Information
Intended Use
The intended use of this device is to record ECG signals
from surface ECG electrodes. This device can analyze,
record, and store electrocardiographic information from
adult and pediatric populations. This data can then be
computer analyzed with various algorithms such as
interpretive ECG and signal averaging for presentation to
the user.
This device is intended for use under the direct
supervision of a licensed health care practitioner.
This device is not intended for use with high frequency
surgical units. Disconnect the patient from the device
before using the high frequency surgical unit.
This equipment uses a computerized ECG analysis
program which can be used as a tool in ECG tracing
interpretation.

MAC 5000 System — 2000657-024, Revision A
Introduction: Safety Information
1-10
To ensure accuracy, only use computer-generated
tracings and not the display for physician interpretation.
This equipment will not cause abnormal operation of a
patient’s pacemaker or other electronic stimulator.
The Acute Cardiac Ischemia–Time Insensitive Predictive
Instrument (ACI-TIPI ) Option is intended to be used in
a hospital or clinical environment by competent health
professionals. ACI-TIPI uses recorded ECG data to
produce a numerical score which is the predicted
probability of acute cardiac ischemia. Like any
computer-assisted ECG interpretation program, the GE
Medical Systems Information Technologies ACI-TIPI
evaluation and probability score is intended to
supplement, not substitute for, the physician’s decision
process. It should be used in conjunction with
knowledge of the patient’s history, the results of a
physical examination, the ECG tracing, and other clinical
findings.
ACI-TIPI is intended for adult patient populations.

Introduction: Safety Information
MAC 5000 System — 2000657-024, Revision A 1-11
Recording ECGs During Defibrillation
This equipment is protected against the effects of cardiac
defibrillator discharge to ensure recovery, as required by
test standards.
The patient signal input of the acquisition module is
defibrillation-proof. Therefore, it is not necessary to
remove the ECG electrodes prior to defibrillation.
When using stainless steel or silver electrodes a
defibrillator discharge current may cause the electrodes
to retain a residual charge causing a polarization or dc
offset voltage. This electrode polarization will block
acquisition of the ECG signal. To avoid this condition,
use non-polarizing electrodes (which will not form a dc
offset voltage when subjected to a dc current) such as
silver/silver-chloride types if there is a situation where
there isa likelihood that a defibrillation procedure will be
necessary.
If polarizing electrodes are used, we recommend
disconnecting the leadwires from the patient before
delivering the shock.
Electrode defibrillation recovery is the ability of the
electrode to allow the ECG trace to return after
defibrillation. We recommend using non-polarizing
disposable electrodes with defibrillation recovery ratings
as specified in AAMI EC12 3.2.2.4. (MMS P/N 9623-
105 Silver MacTrodes, MMS spec. TP9623-003). AAMI
EC12 requires that the polarization potential of an
electrode pair does not exceed 100mV, 5 seconds after a
defibrillation discharge.

MAC 5000 System — 2000657-024, Revision A
Introduction: Safety Information
1-12
Accuracy of the Input Signal Reproduction
n Overall System Error is tested using the method
described in AAMI EC11 3.2.7.1. Overall System
Error is +5%.
n Frequency Response is tested using the method
described in AAMI EC11 3.2.7.2 methods A and
D.
Modulating Effects in Digital Systems
This device uses digital sampling techniques that may
produce some variation in amplitudes of Q, R, and/or S
waves from one heart beat to the next, which may be
particularly noticeable in pediatric recordings. If this
phenomenon is observed, the clinician should be aware
that the origin of amplitude variations is not entirely
physiologic. For measuring voltages of Q, R, and S
waves, it is advisable to use the QRS complexes with the
largest deflection of the particular waves.
Installation and Connection
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.
Contact GE Medical Systems Information Technologies
for information before connecting any devices to this
equipment that are not recommended in this manual.