127(The information in this manual only applies to MAC 1200 software version 6. It does not apply to
earlier software versions. Due to continuing product innovation, specifications in this manual are subject to
change without notice.
Listed below are GE Med ica l Sy stem s Information Technologies trademarks. All other trademarks contained
herein are the property of their respective owners.
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, CORO, COROLAN, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, DASH,
Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STORE,
INTELLIMOTION, IQA, LASER SXP, MAC, MAC-LAB, MACTRODE, MANAGED USE, 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, MULTISCRIPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT,
OnlineABG, OXYMONITOR, Pres-R-Cuff, PRESSURE-SCRIBE, QMI, QS, Quantitative Medicine,
Quantitative Sentinel, RAC RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOLARVIEW, Spectra
400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM
KNOB, Trimline, UNION STATION, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic,
VariCath, VARIDEX, VAS, and Vision Care Filter are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office.
Res, Premium, Prism, QUIK CONNECT V, QUICK CONNECT, QT Guard, SMART-PAC, SMARTLOOK,
Spiral Lok, S wee the art, UNITY, Univer s al, Wate r fa ll, and Walk mom ar e tra dema rks of GE Med ica l Syst ems
Information Technologies.
The MAC 1200 bears CE mark 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.
The country of manufacture 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 effecti veness of this device has been ve rified 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 device will not impair the
safe and effective use of those previously distributed devices. See user’s
information.
Exceptions
The MAC 1200 EMC: Immunity Performance
Users should be aware of known RF sources, such as radio or TV
stations and hand-held or mobile two-way radios, and consider them
when installing a medical device or system.
Be aware that adding accessories or components, or modifying the
medical device or system may degrade the EMI performance. Consul t
with qualified personnel regarding changes to the system
configuration.
Revision AMAC 1200CE-1
2012250-022
General Information
CE Marking Information
The device is designed to comply with IEC 60601 requirements. It is
a protection class I device.
The CE mark covers only the accessories listed in t he chapter “Orde r
Information”.
The information contained in th is ma nual d escr ibes sof tware ve rsion
This manual has a revision letter, locate d at the bottom of each page.
This revision letter changes whenever t he manual is upd ated. Revisi on A
is the initial release of the document.
Manual Purpose
This manual describes the safe and effective operation of the MAC 1200
unit.
127(
The Basics: About This Manual
RevisionDateComments
A31 March 2003Initial release of manual, describes version 6.0.
This document describes the functionality of the U.S. interface for
the MAC 1200 unit.
Information in this manual differs from operating information for
MAC 1200 units developed for use internationally. Please refer to PN
2012250-021 for information on using the international interface.
Revision AMAC 12001-3
2012250-022
The Basics: MAC 1200 Resting ECG Analysis System Option Codes
MAC 1200 Resting ECG Analysis System Option
Codes
In addition to the software supplied with the unit, optional programs
may be purchased to upgrade the MAC 1200 performance features. In
order to use a new option, you need to activate it by entering the option
code number (refer to Chapter 9, “Option Code” section for details). The
option codes are entered into the MAC 1200 prior to shipping.
Software PackageFunctionalityOption Code
MEASMeasurement (measurement of the 10-second resting ECG)_ _ _ _ _ _ _ _ _ _ _ _
DIAGInterpretation (interpretation of the 10-second resting ECG)_ _ _ _ _ _ _ _ _ _ _ _
MEMOMemory (storage of a maximum of 40 10-second resting ECGs)_ _ _ _ _ _ _ _ _ _ _ _
C100Activates the three options MEAS, DIAG, MEMO for a maximum of 100 ECGs_ _ _ _ _ _ _ _ _ _ _ _
C500Activates the three options MEAS, DIAG, MEMO for a maximum of 500 ECGs_ _ _ _ _ _ _ _ _ _ _ _
EVALActivates the three options MEAS, DIAG, MEMO for a maximum of 4 weeks_ _ _ _ _ _ _ _ _ _ _ _
Serial No:_ _ _ _ _ _ _ _ _
1-4MAC 1200Revision A
2012250-022
The Basics: MAC 1200 Resting ECG Analysis System Option Codes
Intended Use and Functional Description
The MAC 1200 is an ECG acquisition and recording system designed and
manufactured by GE Medical Systems Information Technologies.
It is intended to be used for resting ECG recording and realtime ECG
recording with or without arrhythmia detection.
It is not intended for use as a vital signs physiological monitor.
The arrhythmia detection porti on of the M AC 1200 is pr ovided to the
customer for the convenience of automatic documentation. It is not
designed to provide alarms for arrhythmia detecti on .
The MAC 1200 offers no diagnostic opinion to the user. Instead it
provides ana lytical statement s when configured wi th the appropriate
options.
It is intended to be used by trained operators under direct physician
supervision when ECG records are required.
It is not suitable for intracardiac application.
It is designed for continuous operati on.
It is not intended for home use.
The MAC 1200 is designed as a portable device and can easily be
moved from one patient to another or to different locations. It is not
intended to be used during patient transport.
Equipped with the standard software, the MAC 1200 supports the
following operating modes.
12 Lead Mode (acquisition of 12 leads of ECG for a period of 10
seconds),
6 Lead Mode ( realtime recording of 6 ECG leads), and
Arrhythmia Mode (continuous ECG analysis for arrhythmias).
The graphics display shows 3 leads at a time.
Resting ECGs can be transferred to the CardioSys/CardioSoft or MUSE
CV Information System via the RS232 interface.
The device operates from b oth AC and DC (recharg eable batt eries) power
sources.
Revision AMAC 12001-5
2012250-022
The Basics: MAC 1200 Resting ECG Analysis System Option Codes
The unit’s performance features can be upgraded with the followi ng
optional programs.
MEAS — measurement (measurement of t he 10-s eco nd rest ing E CG)
DIAG — interpretation (int erpre tat io n of the 1 0-seco nd re st ing ECG)
MEMO — memory (storage of a maximum of 40 10-second resting
ECGs)
C100 — activates the three options MEAS, DIAG, MEMO for a
maximum of 100 ECGs
C500 — activates the three options MEAS, DIAG, MEMO for a
maximum of 500 ECGs
EVAL — activates the three options MEAS, DIAG, MEMO for a
period of 4 weeks
The MAC 1200 resting ECG analysis system has a setup menu to
customize th e sy st em pa r am e te r s.
Patient and user data can be entered for reliable and safe archiving of
patient records. The patient name is annotated on each printed report
page. All other data is printed on request.
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The MAC 1200 units are designed to comply with IEC 60601 / EN 60601
requirements. They are protection class I devices/devices with an
internal power source. They are classified as MDD class IIa devices. They
are designed for continuous ope ration. The units are not suitable for
intracardiac application. The units are not intended for use as vital signs
physiological monitors.
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102A
1-6MAC 1200Revision A
2012250-022
The Basics: MAC 1200 Resting ECG Analysis System Option Codes
Intended Audience
Definitions
Black textIndicates keys on the keyboard, text to be entered, or hardware items such as buttons or
This manual is geared for clinical professionals. Clinical professionals
are expected to have working knowledge of medical procedures,
practices, and terminology as required for monitoring of critically ill
patients.
&$87,21
PATIENT HAZARD — Medical technical equipment such
as the MAC 1200 must only be used by qualified and
trained personnel.
The following formats are used in this manual to highlight various web
viewer features and functions.
switches on the equipment.
Italicized textIndicates software terms that identify menu items, buttons, or options in various windows.
Ctrl+EscIndicates 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 space bar. When instructions are given for typing a precise
text string with one or more spaces, the point where the space bar must be pressed is
indicated as: <Space>. The purpose of the < > brackets is to ensure you press the space
bar when required.
EnterIndicates you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.
Illustrations and Names
All illustrations in this manual are provided as examples only. They may
not necessarily reflect your monitoring setup or data displayed on your
monitor.
In this manual, all names appearing in examples and illustrations are
fictitious. The use of any real person’s name is purely coincidental.
Revision AMAC 12001-7
2012250-022
Safety Information
This manual is an integral part of the device. It should always be kept
near the device. Close observance of the informa tion given in t he manual
is a prerequisite for proper device performance and correct operation and
ensures patient and operator safety. Please n ote that information
pertinent to several chapters is given only once. Therefore, carefully read
the manual o nce in its entirety.
The symbol means: Consult accompanying documents. It indicates
points whi ch are of particul ar importance in the operation of the device.
This manual is in conformity with the devi ce specifications and
standards on safety of electromedical equipment valid at th e time of
printing. All rights are reserved for devices, circuits, techniques,
software programs, and names appearing in this manual.
On request GE will provide a service manual.
The GE quality management system complies with the standards DIN
EN ISO 9001 and EN 46001.
The Basics: Safety Information
To ensure patient safety, the specified measuring accuracy, and
interference-free operation, we recommend to use only original GE
components. The user is responsible for application of accessories from
other manufacturers.
The warranty does not cover damage resulting f rom the use of unsuitab le
accessories and consumables from other manufacturers.
GE is responsible for the effects on safety, reliability, and performance of
the device, only if
assembly operations, extensions, readjustments, modifications, or
repairs are carried out by GE or by persons authorized by GE, and
the device is used in accordance with the instructions given in this
operator’s manual.
1-8MAC 1200Revision A
2012250-022
Definitions
The Basics: Safety Information
The terms danger, warning, and caution are used throughout this
manual to point out hazards and to designate a degree or level of
seriousness. Familiarize yourself with their definitions and significance.
Hazard is defined as a source of potential injury to a person.
'$1*(5 indicates an imminent hazard which, if not avoided, will
result in death or serious injury.
:$51,1* indicates a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.
&$87,21 indicates a potential hazard or unsafe practice which, if not
avoided, could result in minor personal injury or product/property
damage.
127( provides application tips or other useful information to assure
that you get the most from your equipment.
The safety information given in this manual is classified as follows.
'$1*(5
EXPLOSION HAZARD — The device is not designed for
use in areas of medically used rooms where an explosion
hazard may occur. An explosion hazard may result from
the use of flammable anesthetics, skin cleansing agents
and disinfectants.
Revision AMAC 12001-9
2012250-022
The Basics: Safety Information
:$51,1*6
SHOCK HAZARD — Strictly observe the following
warnings. Failure to do so may endanger the lives of the
patient, the user and bystanders.
Before using the device, the operator must ascertain
that it is in correct working order and operating
condition. In particular, all connectors, electrodes as
well as sensors and probes must be checked for signs
of damage. Damaged parts must be replaced
immediately, before use.
When disconnecting the device from the power line,
remove the plug from the wall outlet first, before
disconnecting the cable from the device. Otherwise
there is a risk of coming in contact with line voltage
by inadvertently introducing metal parts in the
sockets of the power cord.
The mains plug must be connected to an appropriate
power supply with a non-fused grounded-to-earth
wire. If these requiremen ts cannot be met, operate
the device on battery power.
Do not use multiple portable socket outlets (MPS O)
to connect the device to the power line.
Devices may be connected t o other devices or to parts
of systems only when it has been made certain that
there is no danger to the pat ient, the opera tors, or the
environment as a result. In those instances where
there is any element of doubt concerning the sa fety of
connected devices, the user must contact the
manufacturers concerned or other informed experts
as to whether there is any possible danger to the
patient, the operator, or the environment as a result
of the proposed combination of devices. Standards
IEC 60601-1-1/EN60601-1-1 must be complied with
in all cases.
All devices of a system must be connected to the same
electric circuit. Devices which are not connected to
the same circuit must be electrically isolated (isolated
RS232 interface).
1-10MAC 1200Revision A
2012250-022
The Basics: Safety Information
:$51,1*6
EQUIPMENT FAILURE — Magnetic and electrical
fields are capable of interfering with the proper
performance of the device. For this reason make sure
that all peripheral devices operated in the vicinity of the
recorder comply with the relevant EMC requirements. Xray equipment, MRI devices, radio systems (cellular
telephones) etc. are possible sources of interference as
they may emit higher leve ls of electr omagneti c radiati on.
Keep the recorder away from t hese devices and verify the
recorder performance before use.
SUFFOCATION HAZARD — Dispose of the packaging
material, observing the applicable waste-control
regulations. Keep the packaging material out of
children's reach.
&$87,216
EQUIPMENT DAMAGE — Devices intended for
emergency application must not be exposed to low
temperatures during storage and transport to avoid
moisture condensation at the application site. Wait until
all moisture has vaporized before using the device.
EQUIPMENT DAMAGE — Before connecting the device
to the power line, verify that the ratings of your local
power line are those indicated on the device nameplate.
RESTRICTED SALE — U.S. federal law restricts this
device to sale by or on the order of a physician.
Revision AMAC 12001-11
2012250-022
The Basics: Safety Information
4P41
Classification
The unit is classified, according to IEC 60601-1, as:
Type of protection against electrical shockClass I internally powered equipment
Degree of protection against electrical
shock
Degree of protection against harmful
ingress of water
Degree of safety of application in the
presence of a flammable anesthetic
mixture with air or with oxygen or nitrous
oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer
Mode of operationContinuous operation
Type CF defibrillation-proof applied part
Ordinary Equipment (enclosed equipment without protection against ingress of
water)
Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide
Not applicable
Underwriters Laboratories, Inc.
Medical Equipment
With respect to electric shock, fire and mechanical hazards
only in accordance with UL 2601-1, and CAN/CSA C22.2
NO. 601.1.
1-12MAC 1200Revision A
2012250-022
Biocompatibility
Literature
The Basics: Biocompatibility
The parts of the product described in this operator manual, including all
accessories, that come in contact with the patient during the intended
use, fulfill the biocompatibility requirements of the applicable standards.
If you have questions in this matter, please contact GE Medical Systems
Information Technologies or its representatives.
Medical Device Directive of August 2, 1994
EN 60601-1: 1990 + A 1: 1993 + A 2: 1995
Medical electrical equipment. General requirements for safety.
EN 60601-1-1: 9/1994 + A1: 12/1995
General requirements for safety. Requirements for the safety of medical
electrical syst e ms.
IEC-Publication 513/1994: Fundamental aspects of safety standards for
medical equipment.
Revision AMAC 12001-13
2012250-022
Service Information
Requirements
Refer equipment servicing to GE Medical Systems Information
Technologies’ authorized service personnel only. Any unauthorized
attempt to repair equipment under warranty voi ds that warranty.
It is the user’s responsibility to report the need for service to GE Medical
Systems Information Technologies or to one of their authorized agents.
Every GE Medical Systems Information Technologies device has a
unique serial number for identification. The serial number appears on
the device label.
The Basics: Service Information
A
B
FEDCG
Table 1. Equipment Identification
ItemDescription
Aname of device
Bmanufacturer
Clocation code
Dserial number
Eunique product code
Flast digit of year manufactured
Gmonth manufactured
105A
1-14MAC 1200Revision A
2012250-022
2Controls and Indicators
Revision AMAC 12002-1
2012250-022
For your notes
2-2MAC 1200Revision A
2012250-022
Controls and Indicators: General Information
General Information
Controls and indicators of the MAC 1200 electrocardiograph are shown
in this chapter.
MAC 1200 Control Panels
1
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1200
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Description
1Power input
2Paper door, windows allows you to check the paper supply
3Patient cable connector
4Connection for electrode application system KISS (option)
5Serial interface (See Chapter 13, “Technical Specifications” for details.)
001A
Revision AMAC 12002-3
2012250-022
Controls and Indicators: General Information
MAC 1200 Keyboard
1234567891011
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standbybattery low
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muscle
filter
gain
pat
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store/
retrieve
copysetup
lead
12
6
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start
stop
13
14
15
2322212019181716
Description
1Power switch (ON/OFF)
2Keys to select a higher or lower HR alarm limit
3Confirms entered data
4Correction key (entry of data)
5Displays the configuration menu
6Enables/disables the muscle filter (elimination of muscle artifact)
7Selects the writer speed 25, 50 or 5 mm/s in 6-Lead Mode and the report formats in 12-Lead Mode
8Selects the gain (5, 10, 20, 40 mm/mV)
9Press to print the report or additional copies of the ECG, or to send/receive ECGs
10Selects the ECG leads displayed and recorded in 6-Lead Mode and displayed 12-Lead Mode
11Sends ECG to memory/retrieves ECG from memory
12Selects the 12-Lead Mode
13Selects the 6-Lead Mode
14Selects the Arrhythmia Mode
15Starts and stops the recorder, clears the setup menu and terminates patient data entry
098A
16Indicators:
Green: recording in selected mode started;
Yellow: recording in selected mode stopped
2-4MAC 1200Revision A
2012250-022
Controls and Indicators: General Information
Description
17Enables entry of patient data
18Indicator lights up when battery needs to be recharged
19Indicator is illuminated when unit is connected to the power line
20Cursor control keys
21Space bar
22Shift key
23Press to access special characters
Revision AMAC 12002-5
2012250-022
Symbols
Controls and Indicators: Symbols
Consult accompanying documents
Signal input
Type CF signal input, highly insulated, defibrillation-proof
Start
Stop
2-6MAC 1200Revision A
2012250-022
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