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
WARNING:
EQUIPMENT MALFUNCTION/INTERFERENCE - Use of portable phones or other radio
frequency (RF) emitting equipment near the system may cause unexpected or
adverse operation.
Do not use portable phones or other electronic equipment that may emit radio
frequency (RF) near this system.
WARNING:
EQUIPMENT MALFUNCTION/INTERFERENCE - Do not use the equipment or system
adjacent to, or stacked with, other equipment.
If adjacent or stacked use is necessary, test the equipment or system to verify
normal operation in the configuration in which you are using it.
WARNING:
ACCESSORIES/COMPONENTS - Adding accessories or components, or modifying
the medical device or system, may result in increased EMISSIONS or decreased
IMMUNITY of the device or system.
Safety Information
CAUTION:
ACCESSORIES/COMPONENTS - Ensure that all cables are less than 3 meters long.
Cable lengths greater than 3 meters may result in decreased IMMUNITY of the
device or system.
CAUTION:
ACCESSORIES (SUPPLIES)
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE Medical Systems Information Technologies. Parts and
accessories used must meet the requirements of the applicable IEC 60601 series
safety standards and essential performance standards, and/or the system
configuration must meet the requirements of the IEC 60601-1-1 medical electrical
systems standard.
CAUTION:
ACCESSORIES (EQUIPMENT)
The use of ACCESSORY equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the
resulting system. 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 60601-1
and/or IEC 60601-1-1 harmonized national standard.
WARNING:
DATA LOSS - Formatting the device’s internal flash drive erases all the data in
memory and returns the device to its factory settings.
If possible, back up or record any data that you do not want to lose before
performing the following procedure.
2109599-003 A MAC™ 7 Resting ECG Analysis System 11
Safety Information
WARNING:
EQUIPMENT FAILURE AND HEALTH HAZARDS - Failure on the part of all responsible
individuals, hospitals or institutions, employing the use of this system, to
implement the recommended maintenance schedule, may cause equipment
failure and possible health hazards. The sole responsibility rests with the
individuals, hospitals, or institutions utilizing the system. The manufacturer does
not, in any manner, assume the responsibility for performing the recommended
maintenance schedule, unless an Equipment Maintenance Agreement exists.
CAUTION:
DISPOSAL HAZARD
Disposable devices are intended for single use only. They should not be reused as
performance may degrade or contamination could occur.
CAUTION:
DISPOSAL HAZARD - At the end of its service life, the product described in this
manual, as well as its accessories, must be disposed of in compliance with local,
state, or federal guidelines regulating the disposal of such products.
If you have questions concerning disposal of the product, please contact GE or its
representatives.
CAUTION:
INTERCONNECTED DEVICES - When several items of medical equipment are
interconnected, summation of leakage current must meet the leakage current as
per IEC 60601-1.
Connect the device only to the GE approved supplies and accessories.
CAUTION:
ISOLATION FROM SUPPLY MAINS
Do not position the device so that it is difficult to operate the disconnection of the
AC power supply of the device.
Supplies and Accessories
This section is in regard to the supplies and accessories you may purchase for your
product.
You should use only supplies and accessories recommended by GE Healthcare. For a
list of recommendations, refer to the supplies and accessories guide for this system.
Contact GE Healthcare before using anything that is not recommended for this
system.
12 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Product and Packaging Information
3
Product and Packaging Information
Hardware Label Locations
The following illustrations and table describe the labels and their location on your
device and its packaging.
2109599-003 A MAC™ 7 Resting ECG Analysis System 13
Product and Packaging Information
14 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Table 3: Label Descriptions on the Device and Packaging
Item Label Location Description
Product and Packaging Information
1 Device Address
Label and Rating
Plate
2 Country-specific
Label
3 Serial Number
Label
4 Option Code
Label
5 Wireless Label Back of the
Back of the
device
Back of the
device
Back of the
device
Back of the
device
device
Provides regulatory and cautionary information. See
"Device Address Label and Rating Plate" on page 17
for an explanation of the label.
Contains registration information for China and Latin
America.
Identifies this device. See "Serial Number Label" on
page 17 for a description of the label contents.
Use the option codes to setup the purchased options
in your system.
Depending on the customer's wireless option, the label
will differ:
Default wireless option:
FIPS wireless option:
6 MAC Address
Label
2109599-003 A MAC™ 7 Resting ECG Analysis System 15
Back of the
device
Indicates the MAC address of the device.
Product and Packaging Information
Item Label Location Description
7 Shipping Label On the shipping
package
8 RED Lable On the shipping
package
Indicates the shipping address where the device is
delivered.
Contains registration information of Radio Equipement
Directive.
9 Environmental
Symbols
10 Battery Shipping
Label
On the shipping
package
These symbols containing warning and caution
indicators are required for shipping. For a full
description of symbols, see "Symbol Descriptions" on
page 18.
FRAGILE—Lithium Ion batteries can cause fire if
damaged.
16 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Equipment Identification
Serial Number Label
The serial number label is in the following format:
Equipment Identification
4
Table 4: Serial Number Label Format
Item Description
1 Product Name
2 Date of Manufacture in YYYY-MM-DD Format
3 Country of Origin
4 Device Serial Number
5 UDI Barcode
6 Product Part Number
Device Address Label and Rating Plate
The device address label and rating plate is in the following format:
2109599-003 A MAC™ 7 Resting ECG Analysis System 17
Equipment Identification
Table 5: Device Address Label and Rating Plate Format
Item Description
1 Product name
2 Manufacturer name and address
3 Electrical rating of the device
4 Symbols
See "Symbol Descriptions" on page 18 for a description of the symbols used on this
label.
Symbol Descriptions
The following table describes symbols or icons that are on the device or its packaging.
Any symbol on your device or packaging with markings in color indicates there
may be a danger, warning, or mandatory action. Any symbol on your device or
packaging that is in black and white provides additional information or may indicate
a caution. Familiarity with these symbols assists in the proper use and disposal of the
equipment.
For equipment symbols not shown, refer to the original equipment manufacturer
(OEM) manuals.
Table 6: Symbols, Icons, and Descriptions
Symbol Description
Catalog or Orderable Part Number
Indicates the manufacturer’s catalog or part number.
Serial Number
Indicates the manufacturer's serial number.
18 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Symbol Description
Batch Code or Lot Number
Indicates the manufacturer's batch code or lot number.
Date of Manufacture (Year-Month-Date)
Indicates the original manufacture date for this device.
Manufacturer
Indicates the name and address for the manufacturer of this device. It may
also include the date it was manufactured.
Rx Only
US Federal law restricts this device to sale by or on the order of a physician.
12SL
Indicates the device uses the Marquette™ 12SL ECG Analysis Program to
analyze and interpret ECG readings.
Equipment Identification
IPxx IP Code (Ingress Protection Rating)
Classifies and rates the degree of protection provided against the intrusion
of solid objects (such as body parts like hands and fingers, dust, accidental
contact), and liquids.
The first numeral (x) represents the degree of protection against the ingress
of solid objects.
The second numeral (x) represents the degree of protection against the
ingress of liquids.
For products with an IPxx rating, see the Classification of Medical Device in
this chapter for a description of that rating. Not all products have an IPxx
rating.
Regulatory Compliance Mark (RCM)
Indicates compliance with electrical safety, EMC, EME and
telecommunications requirements, as applicable to the product.
Required for Australia and New Zealand.
Wireless Communication
Indicates that that the equipment can be connected through wireless
communication.
Waste Electrical and Electronic Equipment (WEEE)
Indicates this equipment contains electrical or electronic components
that must not be disposed of as unsorted municipal waste but collected
separately. Contact an authorized representative of the manufacturer for
information concerning the decommissioning of your equipment.
2109599-003 A MAC™ 7 Resting ECG Analysis System 19
Equipment Identification
Symbol Description
Follow Instructions For Use
Read and understand the operator's manual before using the device or
product.
As a mandatory action sign, this symbol is identified by a blue background
and white symbol.
This Way Up
Indicates the correct upright position of the package.
Keep Dry
Indicates that you need to keep the container away from rain and other
sources of moisture.
Can Be Recycled
Indicates you may recycle this material or device. Recycle or dispose of in
accordance with local, state, or country laws.
Temperature Limits
Indicates the upper and lower temperature limits for the transportation
and handling of this package. They are indicated next to the upper and
lower horizontal lines.
Humidity Limits
Indicates upper and lower humidity limits for the transportation and
handling of this package. They are indicated next to the upper and lower
horizontal lines.
Atmospheric Limits
Indicates the upper and lower barometric pressure limitations for the
transportation and handling of this package. They are indicated next to the
upper and lower horizontal lines.
Defibrillation-proof Type CF Applied Part
Identifies a defibrillation-proof type CF applied part on medical equipment
that complies with IEC 60601–1.
This device meets the requirements for protection against electric shock for
an earth-free (floating) applied part (one intended for contact with patients)
for cardiac application.
No User– or Field-serviceable Parts
Do not open or disassemble the device for any reason.
Protective Earth (ground)
Identifies the terminal of a protective earth (ground) electrode or any
terminal that is intended for connection to an external conductor for
protection against electric shock in case of a fault.
20 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Symbol Description
Do Not Stack
Indicates that you should not stack the container or place a load on the
container.
CAUTION:
ELECTRIC SHOCK - Indicates the presence of hazardous energy circuits
or electric shock hazards.
To reduce the risk of electric shock hazards, do not open this enclosure.
Refer servicing to qualified personnel.
Equipotentiality
Connect non-grounded peripheral devices to ensure equipotential.
Equipment Identification
Environmental Friendly Use Period (EFUP)
Per Chinese standard SJ/T11364–2014, indicates the number of years from
the date of manufacture during which you can use the product before any
restricted substances are likely to leak, causing a possible environmental or
health hazard.
NOTE:
• If the device contains less than the maximum concentration of
restricted substances, the symbol contains a lowercase e
• This is also referred to as China RoHS.
Fragile
Indicates the contents are fragile. Handle with care.
CAUTION:
SAFETY GROUND PRECAUTION - Pulling on the cable can cause the
cord to deteriorate resulting in electrical problems.
Remove the power cord from the mains source by grasping the plug.
DO NOT pull on the cable.
Contains <heavy metal chemical symbol>
Indicates this equipment contains heavy metal and must not be disposed
of as unsorted municipal waste but collected separately. The example
shows Lithium Ion.
Pushing Prohibited
2109599-003 A MAC™ 7 Resting ECG Analysis System 21
Equipment Identification
Serial Number Format
Each device has a serial number that uniquely identifies the device and provides
important information about the device. The serial number format is shown in the
following illustration:
Table 7: Serial Number Format
Item Name Description
1 Product Code A three-character code that uniquely identifies the product line.
2 Year Manufactured A two-digit code identifying the year the device was manufactured.
Values range from 00 to 99. For example: 00 = 2000, 04 = 2004, 17 =
2017 (and so on).
3 Fiscal Week
Manufactured
4 Product Sequence A four-digit number identifying the order in which this device was
5 Manufacturing Site A one-letter code identifying the site where the device was
6 Miscellaneous
Characteristic
Unique Device Identifier
Medical devices require a unique marking for identification—the Unique Device
Identifier (UDI). In the event that you need the UDI for this product, check the product
label on the back of the device.
A two-digit code identifying the week the device was manufactured.
Values range from 01 to 52. GE Healthcare's fiscal weeks
correspond to the calendar week. For example, 01 = the first week in
January.
manufactured.
Values range from 0001 to 9999.
manufactured.
For example, F = Milwaukee, N = Freiburg, P = Bangalore, W = Wuxi,
H = Helsinki, S = Mexico
A one-letter code identifying manufacturing status.
For example, P = the device is a prototype, R = the device was
refurbished, U = the device was upgraded to meet the specifications
of another product code, A = device is in production.
22 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Electromagnetic Compatibility (EMC)
5
Electromagnetic Compatibility (EMC)
Before installing or using the device or system, be aware of the proximity of known
radio frequency (RF) sources, such as the following:
• Radio and TV stations
• Portable and mobile RF communication devices (cell phones, two-way radios)
• X-ray, CT, or MRI devices
These devices are also possible sources of interference as they may emit higher
levels of electromagnetic radiation.
WARNING:
EQUIPMENT MALFUNCTION
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
WARNING:
EQUIPMENT MALFUNCTION OR INTERFERENCE
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.
WARNING:
PATIENT SAFETY/EQUIPMENT FAILURE
Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
2109599-003 A MAC™ 7 Resting ECG Analysis System 23
Electromagnetic Compatibility (EMC)
Guidance and Manufacturer’s Declaration— Electromagnetic Emissions
The system described in this document is intended for use in the following specified
electromagnetic environment. It is the responsibility of the customer or user to ensure
that this system is used in such an environment.
Table 8: EMC Emissions Test
Emissions Test Compliance Electromagnetic Environment
RF emissions (Radiated)
EN 55011
RF emissions (Conducted)
• EN 55011
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/Flicker
emissions
IEC 61000-3-3
Group 1
Class B
Group 1
Class B
Class A
Complies
This device uses RF energy
only for its internal function.
Therefore, its RF emissions
are very low and are not likely
to cause any interference in
nearby electronic equipment.
Class B equipment is
suitable for use in all
establishments, including
domestic establishments and
those directly connected to
the public low-voltage power
supply network that supplies
buildings used for domestic
purposes.
Guidance and Manufacturer’s Declaration— Electromagnetic Immunity
The system described in this document is intended for use in the following specified
electromagnetic environment. It is the responsibility of the customer or user to ensure
that this system is used in such an environment.
24 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Electromagnetic Compatibility (EMC)
Table 9: EMC Immunity Test
Immunity Test EN60601 Test Level Compliance Level Electromagnetic
Environment–
Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical Fast
Transient/burst (EFT)
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
± 8 kV contact
± 15 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
< 5% Ut (> 95% dip in
Ut) for 0.5 cycles
< 40% Ut (> 60% dip in
Ut) for 5 cycles
< 70% Ut (> 30% dip in
Ut) for 25 cycles
< 5% Ut (> 95% dip in
Ut) for 5 s
± 8 kV contact
± 15 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
< 5% Ut (> 95% dip in
Ut) for 0.5 cycles
< 40% Ut (> 60% dip in
Ut) for 5 cycles
< 70% Ut (> 30% dip in
Ut) for 25 cycles
< 5% Ut (> 95% dip in
Ut) for 5 s
Floors should be wood,
concrete, or ceramic
tile. If the floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Mains power should
be that of a typical
commercial or hospital
environment.
Mains power should
be that of a typical
commercial or hospital
environment.
Mains power should
be that of a typical
commercial or hospital
environment.
Ut is the AC mains
voltage prior to
application of the test
level.
If the user requires
continued system
operation during
power mains
interruptions, it is
recommended that
the system is powered
from an applicably
rated uninterruptible
power supply or a
battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
2109599-003 A MAC™ 7 Resting ECG Analysis System 25
30 A/m 30 A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Electromagnetic Compatibility (EMC)
Immunity Test EN60601 Test Level Compliance Level Electromagnetic
Environment–
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
0.15 MHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz and
80 MHz
3 V/m at 80 to 2700
MHz, AM Modulation
9 to 28 V/m at 385
to 6000 MHz, FM or
Digital Modulation
3 Vrms
0.15 MHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz and
80 MHz
3 V/m at 80 to 2700
MHz, AM Modulation
9 to 28 V/m at 385
to 6000 MHz, FM or
Digital Modulation
Recommended
separation distance:
d = 12√P
d = 1.2 √P 80 MHz to
800 MHz
d = 2.3 √P 800 MHz to
2.5 GHz
At 80 MHz and 800
MHz, the higher
frequency range
applies.
Recommended
separation distance:
where P is the
maximum output
power rating of
the transmitter in
watts (W) according
to the transmitter
manufacturer, and d
is the recommended
separation distance in
meters (m).
Field strengths from
fixed RF transmitters,
as determined by an
electromagnetic site
survey, should be less
than the compliance
level in each frequency
range.
Interference may
occur in the vicinity
of equipment marked
with the following
symbol:
26 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Electromagnetic Compatibility (EMC)
Immunity Test EN60601 Test Level Compliance Level Electromagnetic
Environment–
Guidance
NOTE:
• Do not use portable or mobile RF communications equipment closer to any part of the
system, including the cables, than the recommended separation distance calculated for the
equation applicable to the frequency of the transmitter.
• Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot,
theoretically, be predicted with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, consider conducting an electromagnetic site survey. If the
measured field strength in the location the system is used exceeds the applicable RF
compliance level listed in this table, observe the system to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by
the reflection from structures, objects, and people.
Recommended Separation Distances
The following table provides the recommended separation distances (in meters)
between portable and mobile RF communication equipment and the system
described in this manual, for equipment and systems that are not life-supporting.
The system is intended for use in the electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the system can help
prevent electromagnetic interference by maintaining the following recommended
minimum distance between portable and mobile RF communications equipment
(transmitters) and the system, according to the maximum output power of the
communications equipment.
Table 10: Recommended Separation Distances
Rated
Maximum
Output
Power of
Transmitter
in Watts (W)
Separation Distance (meters) According to Frequency of Transmitter
150 kHz to 80 MHz
d (meters) = 3.5/V1 x √ P
d (meters) for V1 = 3 Vrms
80 MHz to 800 MHz
d = 3.5/E1 x √ P
d for E1 = 3 V/m
1
2
800 MHz to 2.5 GHz
d = 7/E1 x √ P
d for E1 = 3 V/m
Meters Feet Meters Feet Meters Feet
0.01 0.117 0.383 0.117 0.383 0.233 0.766
0.1 0.369 1.210 0.369 1.210 0.738 2.421
1 1.167 3.828 1.167 3.828 2.333 7.655
2109599-003 A MAC™ 7 Resting ECG Analysis System 27
Electromagnetic Compatibility (EMC)
Rated
Maximum
Output
Power of
Transmitter
in Watts (W)
Separation Distance (meters) According to Frequency of Transmitter
150 kHz to 80 MHz
d (meters) = 3.5/V1 x √ P
d (meters) for V1 = 3 Vrms
80 MHz to 800 MHz
d = 3.5/E1 x √ P
d for E1 = 3 V/m
2
800 MHz to 2.5 GHz
d = 7/E1 x √ P
d for E1 = 3 V/m
1
Meters Feet Meters Feet Meters Feet
10 3.689 12.104 3.689 12.104 7.379 24.208
100 11.667 38.276 11.667 38.276 23.333 76.552
NOTE:
1
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
2
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
For transmitters rated at a maximum output power not listed above, estimate the recommended
separation distance d in meters (m) using the equitation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
28 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Wireless Regulations
The wireless and wired LAN functionality of the MAC 7 is used to retrieve ECG orders
and send ECG reports to an ECG Management System. In addition, the wireless
and wired LAN functionality can be used to interface to other hospital information
systems to provide additional data to the care giver operating the electrocardiograph.
These tasks are an adjunct to the device’s intended use of acquiring, analyzing,
displaying and printing an electrocardiogram. Because the wireless and wired
LAN functionality is not required for the device to fulfill its intended use, network
performance is not critical to the performance of the device. Furthermore, the MAC 7
does not transmit any real-time data or alarm information over the network. Network
Quality of Service (QoS) parameters such as reliability of data transmission, latency,
transfer rate, error rate, and priority levels are not critical to the MAC 7 functionality
and are not specified.
Wireless Regulations
6
FCC Compliance
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
CAUTION:
Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the
equipment.
NOTE:
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which
2109599-003 A MAC™ 7 Resting ECG Analysis System 29
Wireless Regulations
Limited by local law regulations, version for North America does not have region
selection option.
To satisfy FCC RF exposure requirements, a separation distance of 20 cm or more
should be maintained between the antenna of this device and persons during device
operation.
To ensure compliance, operations at closer than this distance is not recommended.
can be determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
IC Compliance
This device contains licence-exempt transmitter(s)/receiver(s) that comply with
Innovation, Science and Economic Development Canada’s licence-exempt RSS(s).
Operation is subject to the following two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause
undesired operation of the device.
L’émetteur/récepteur exempt de licence contenu dans le présent appareil est
conforme aux CNR d’Innovation, Sciences et Développement économique Canada
applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux
deux conditions suivantes:
1. L’appareil ne doit pas produire de brouillage;
2. L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage
est susceptible d’en compromettre le fonctionnement.
This equipment complies with radio frequency exposure limits set forth by the
Innovation, Science and Economic Development Canada for an uncontrolled
environment.
This equipment should be installed and operated with a minimum distance of 20 cm
between the device and the user or bystanders.
This device must not be co-located or operating in conjunction with any other
antenna or transmitter.
Cet équipement est conforme aux limites d'exposition aux radiofréquences définies par
la Innovation, Sciences et Développement économique Canada pour un environnement
non contrôlé.
30 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Cet équipement doit être installé et utilisé avec un minimum de 20 cm de distance
entre le dispositif et l'utilisateur ou des tiers.
Ce dispositif ne doit pas être utilisé à proximité d’une autre antenne ou d’un autre
émetteur.
The device for operation in the band 5150-5250 MHz is only for indoor use to reduce
the potential for harmful interference to co-channel mobile satellite systems;
les dispositifs fonctionnant dans la bande de 5 150 à 5 250 MHz sont réservés
uniquement pour une utilisation à l'intérieur afin de réduire les risques de brouillage
préjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux;
RED Information
The MAC 7 embedded wireless module complies with CE RED 2014/53/EU.
Wireless Regulations
This product is restricted to indoor use.
Frequency Range 2.4 GHz frequency bands: 2.4-2.483 GHz
5 GHz frequency bands: 5.15-5.35 GHz, 5.47-5.725 GHz
Maximum RF output
power
20 dBm
2109599-003 A MAC™ 7 Resting ECG Analysis System 31
GE Medical Systems
Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223 USA
Tel:+1 414 355 5000
Tel: +1 800 558 7044 (US Only)
GE Medical Systems Information Technologies, Inc., a General Electric Company, going to market as GE Healthcare.
www.gehealthcare.com
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