GE Medical Systems Information Technologies MAC7 User Manual
GE Healthcare
MAC™ 7 Resting ECG Analysis System
Version 1.00
Regulatory and Safety Manual
2109599-003 A
MAC™ 7 Resting ECG Analysis System
Version 1.00
English
©
2018 General Electric Company
All Rights Reserved.
Publication Information
This document describes version 1.00 of MAC™ 7 Resting ECG Analysis System, also referred to as the “product” or "system" or "device".
It does not apply to earlier product versions. Due to continuing product innovation, specifications in this document are subject to change
without notice.
MUSE, MAC, MARS, CASE, CardioSoft, and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a General
Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners.
The MAC ™7 Resting ECG Analysis System is intended to be used, under the direct supervision of a licensed healthcare practitioner by
trained operators in a hospital or facility providing patient care.
This document provides information required for the proper use of the system. Familiarize yourself with this information and read and
understand all instructions before attempting to use this system.
NOTE:
Illustrations in this document are provided as examples only. Depending on system configuration, screens in the document may differ
from the screens on your system. Patient names and data are fictitious. Any similarity to actual persons is coincidental.
The document part number and revision are on each page of the document. The revision identifies the document’s update level. The
revision history of this document is summarized in the following table.
Revision Date Comment
A 15 August 2018 Initial Release
To access other GE Healthcare Diagnostic Cardiology documents, go to the Common Documentation Library (CDL), located at http://
apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library, and click Cardiology.
To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website.
Support
GE Healthcare maintains a trained staff of application and technical experts to answer questions and to respond to issues and problems
that may arise during the installation, maintenance, and use of this product.
If you require additional assistance, contact your GE Healthcare representative or GE Healthcare support at one of the following numbers:
• North America: 1-800-558-7044
• Europe: +49 761 45 43 -0
• Asia: +86 21 3877 7888
Training
This document is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the use
of the product, you should request training assistance from GE Healthcare.
To see available training, go to the GE Healthcare training website (www.gehealthcare.com/training). Select Education> Product
Education-Technical> Diagnostic Cardiology. For more self-paced course offerings, tools, and reference guides you may find useful,
please visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.
2 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Table of Contents
Publication Information....................................................................... 2
1:Regulatory Information.......................................................................................4
Intended Use............................................................................................................................................................4
Indications for Use................................................................................................................................................ 4
Contraindications...................................................................................................................................................5
Prescription Device Statement........................................................................................................................5
Classification of Medical Device.....................................................................................................................5
Recording ECGs during Defibrillation........................................................................................................... 5
Modulating Effects in Digital Systems......................................................................................................... 6
Biocompatibility.......................................................................................................................................................6
Legal Notice..............................................................................................................................................................6
Responsibility of the Manufacturer............................................................................................................... 7
Responsibility of the Purchaser/Customer................................................................................................ 7
Warranty Information..........................................................................................................................................7
2:Safety Information............................................................................................... 8
Safety Conventions............................................................................................................................................... 8
Safety Hazards........................................................................................................................................................8
Supplies and Accessories................................................................................................................................12
3:Product and Packaging Information...............................................................13
Hardware Label Locations..............................................................................................................................13
4:Equipment Identification...................................................................................17
Serial Number Label.......................................................................................................................................... 17
Device Address Label and Rating Plate................................................................................................... 17
Symbol Descriptions.......................................................................................................................................... 18
Serial Number Format...................................................................................................................................... 22
Unique Device Identifier...................................................................................................................................22
5:Electromagnetic Compatibility (EMC)............................................................. 23
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions................................24
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity.................................24
Recommended Separation Distances.......................................................................................................27
6:Wireless Regulations......................................................................................... 29
FCC Compliance...................................................................................................................................................29
IC Compliance.......................................................................................................................................................30
RED Information...................................................................................................................................................31
Regulatory Information
Regulatory Information
Familiarize yourself with this information before attempting to use this system.
Keep this manual with your Operator Manual and equipment at all times, and
periodically review it.
This section provides information about the regulatory compliance of this system.
The system software is considered medical software. As such, it was designed and
manufactured to the appropriate medical regulations and controls.
1
Intended Use
The system is intended to acquire, analyze, display, and record electrocardiographic
information from adult, pediatric or neonatal populations. Basic system delivers 3,6,
or 12 lead ECG’s and interpretive analysis. Transmission and reception of ECG data
and other clinical data to and from a central clinical information system is optional.
The system is intended to be used under the direct supervision of a licensed
healthcare practitioner, by trained operators in a hospital or medical professional’s
facility.
Indications for Use
This device is a non-invasive prescription device.
The device is indicated for use:
• To acquire, analyze, display and print electrocardiograms.
• To provide interpretation of the data for consideration by a physician.
• In a clinical setting, by a physician or by trained personnel who are acting on the
orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of ECG offered by the device are only significant when used
in conjunction with a physician over-read as well as consideration of all other
relevant patient data.
• On adult and pediatric (birth through 21 years of age) populations.
4 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Contraindications
This system is not intended for use in the following manner:
• During patient transport
• With high-frequency surgical units
• As an intra-cardiac application
• As a sole means of diagnosis
• As a vital signs physiological monitor
Prescription Device Statement
CAUTION:
Regulatory Information
United States federal law restricts this device to sale by or on the order of a
physician.
Classification of Medical Device
The device is classified as follows according to IEC 60601-1.
Table 1: Medical Device Classifications
Category Classification
Type of protection against electrical shock Class I, internally powered
Degree of protection against electrical shock Type CF defibrillation-proof applied part
Degree of protection against harmful ingress of
solids and liquids
Degree of safety of application in the presence
of a flammable anesthetic mixture with air or
with oxygen or with nitrous oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer
The Ingress Protection (IP) code for this device is
IP 20.
Equipment is not suitable for use in the presence
of a flammable anesthetic mixture with air or
with oxygen or with nitrous oxide
Not applicable
Mode of operation Continuous operation
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. It is not necessary to remove the ECG
electrodes prior to defibrillation.
2109599-003 A MAC™ 7 Resting ECG Analysis System 5
Regulatory Information
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 blocks acquisition of the ECG signal. To avoid this
condition, if there is a situation where a defibrillation procedure is necessary, use
non-polarizing electrodes such as silver/silver-chloride types, which do not form a DC
offset voltage when subjected to a DC current.
If you use polarizing electrodes, GE Healthcare recommends 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. GE Healthcare recommends using non-polarizing
disposable electrodes with defibrillation recovery rating as specified in AAMI
EC12.5.2.2.4. AAMI EC12 requires that the polarization potential of an electrode pair
does not exceed 100 mV 5 seconds after a defibrillation discharge.
Refer to the supplies and accessories guide for this system for a list of approved
electrodes.
Modulating Effects in Digital Systems
This section describes the modulating effects that may occur in digital systems of the
product.
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 you observe this phenomenon,
be aware that the origin of amplitude variations is not entirely physiological. For
measuring voltages of Q, R, and S waves, GE Healthcare advises using the QRS
complexes with the largest deflection of the particular waves.
Biocompatibility
The parts of the system described in this manual that come into contact with the
patient during the intended use, including all accessories, fulfill the biocompatibility
requirements of the applicable standards. If you have questions in this matter contact
your GE Healthcare representative.
Legal Notice
GE Healthcare software contains several fields that can be populated before
performing an ECG. Some of these fields are required, others are optional and
left to the user to assess whether they are needed to perform the exam. The field
Race is one of these optional fields. Race 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
6 MAC™ 7 Resting ECG Analysis System 2109599-003 A
collect this type of data, it is your responsibility to ensure that you comply with all
applicable legal requirements.
Responsibility of the Manufacturer
This section describes the responsibility of GE Healthcare as the manufacturer of your
product.
GE Healthcare is responsible for the safety, reliability, and performance of hardware
supplied by GE Healthcare only if the following conditions are met:
• Assembly operations, extensions, readjustments, modifications, or repairs are
performed by persons authorized by GE Healthcare.
• The electrical installation of the room where the device is used complies with the
requirements of the appropriate local, state, and other government regulations.
• The equipment is used in accordance with the instructions for use.
Regulatory Information
Responsibility of the Purchaser/Customer
The customer is responsible for providing appropriate desks, chairs, electrical wall
outlets, network connections, and analog phone lines, and for locating any of the
system components described in the manuals in compliance with all local, state, and
national codes.
Lack of data security may compromise patient privacy. GE Healthcare recommends
that you take appropriate steps to secure the privacy of communication on your
network when using this product.
Warranty Information
This device is considered GE Healthcare-supplied hardware. Only authorized GE
Healthcare service personnel should service the device. Any unauthorized attempt to
repair equipment under warranty voids that warranty. It is the user’s responsibility to
report the need for service to GE Healthcare or to one of their authorized agents.
2109599-003 A MAC™ 7 Resting ECG Analysis System 7
Safety Information
Safety Information
Safety Conventions
This section describes the safety conventions used in the documentation for the
product.
2
A Hazard is a source of potential injury to a person, property, or the system.
The manuals for this system use the terms DANGER, WARNING, CAUTION, and NOTICE
to point out hazards and to designate a degree or level of seriousness. Familiarize
yourself with the following definitions and their significance.
Table 2: Definitions of Safety Conventions
Safety Convention Description
DANGER Indicates an imminent hazard, which, if not avoided will result in death or
WARNING Indicates a potential hazard of unsafe practice, which, if not avoided, could
CAUTION Indicates a potential hazard or unsafe practice, which, if not avoided, could
NOTICE Indicates a potential hazard or unsafe practice, which, if not avoided, could
Safety Hazards
The following safety messages alert you to potentially hazardous conditions that
could arise during the normal use of this product and recommend steps that can be
taken to avoid those conditions. Safety messages pertaining to hazardous conditions
that may arise during specific actions may also be provided during the discussion of
those actions in this or other manuals for this product.
serious injury.
result in death or serious injury.
result in moderate or minor injury.
result in the loss or destruction of property or data
WARNING:
EQUIPMENT MALFUNCTION - Any attempt by unauthorized personnel to service
the device could result in equipment malfunction and void the warranty. This
8 MAC™ 7 Resting ECG Analysis System 2109599-003 A
equipment contains no user-serviceable parts. Refer servicing to authorized
service personnel.
CAUTION:
EQUIPMENT COMPATIBILITY
Compatibility is critical to safe and effective use of this device. Please contact
your local sales or service representative prior to installation to verify equipment
compatibility.
WARNING:
PERSONAL INJURY-STUMBLING HAZARD - Patients can become entangled in the
cables and leadwires connected to the device, which could cause the patient to
stumble or trip.
Route cables and leadwires in a way to avoid creating a stumbling hazard: keep
them off the floor, and route leadwires away from the patient’s legs and the
healthcare provider’s work area.
Safety Information
WARNING:
MAGNETIC AND ELECTRICAL INTERFERENCE - Magnetic and electric fields can
interfere with the acquisition of ECG readings.
Make sure that all peripheral components operated in the vicinity of the device
comply with the relevant EMC requirements. X-ray equipment, MRI devices,
radio systems (cellular phones) and so forth, are possible sources of interference
because they may emit higher levels of electromagnetic radiation. Verify the
performance of the system before use.
WARNING:
EXPLOSION HAZARD - Using this device in the presence of anesthetic vapors or
liquids can cause explosions.
Do not use this device in the presence of anesthetic vapors or liquids. Only persons
with adequate training in the correct use of this device may use this device.
WARNING:
EQUIPMENT FAILURE - Polarizing electrodes (stainless steel or silver constructed)
may cause the electrodes to retain a residual charge after defibrillation. A residual
charge blocks acquisition of the ECG signal.
Whenever patient defibrillation is a possibility, use non-polarizing electrodes
(silver-silver chloride construction) for ECG monitoring.
CAUTION:
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.
2109599-003 A MAC™ 7 Resting ECG Analysis System 9
Safety Information
WARNING:
PERSONAL INJURY - Contact with patients during defibrillation can cause serious
injury or death.
Do not contact patients during defibrillation. Patient signal inputs labeled with
the CF symbols with paddles are protected against damage resulting from
defibrillation voltages. To ensure proper defibrillator protection, use only GE
Healthcare recommended cables and leadwires. Proper placement of defibrillator
paddles in relation to the electrodes is required to ensure successful defibrillation.
CAUTION:
EXPLOSION HAZARD
Do NOT use in the presence of flammable anesthetics vapors or liquids.
WARNING:
INTERPRETATION HAZARD - Results of the automated QT analysis are not
considered a diagnosis.
A qualified physician or cardiologist must review and confirm the measurements
and waveforms recorded by the system. It should be used only as an adjunct to
the clinical history, symptoms, and results of other tests.
WARNING:
INTERPRETATION HAZARD - Computerized interpretation is only significant when
used in conjunction with clinical findings.
A qualified physician must overread all computer-generated tracings.
WARNING:
IMPROPER USE - This is a prescriptive device.
This equipment is intended for use by or under the direct supervision of a licensed
healthcare practitioner.
WARNING:
BATTERY EXPLOSION HAZARD - Batteries may explode in fires.
Do not dispose of the battery by fire or burning. Follow local environmental
guidelines concerning disposal and recycling.
WARNING:
ELECTRIC SHOCK HAZARD/SYSTEM MALFUNCTION - Liquids inside a device can
cause electric shock or system malfunction.
Do not allow liquids to enter the device. If liquids enter the device, turn it off and
inform your service technician. Do not use the device until it is checked by a
service technician.
WARNING:
ELECTRIC SHOCK - Improper connection of this equipment may cause electric
shock.
To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
10 MAC™ 7 Resting ECG Analysis System 2109599-003 A
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