GE MAC 400 User manual

MAC™ 400 Resting ECG Analysis System Safety and Warnings Guide

© 2007, 2008 General Electric Company. All Rights Reserved

The MAC™ 400 Resting ECG Analysis System Safety and Warnings
Guide provides guide details, safety information and symbols definitions.

Guides information

The MAC 400 Resting ECG Analysis System Guides contain the
instructions necessary for operating the MAC 400 system in accordance
with its function and intended use.
The information in these guides only applies to MAC 400 system software
version 1. It does not apply to earlier software versions. Due to continuing
product innovation, specifications in these guides are subject to change
without notice.
MAC™ and Mactrode™ are trademarks owned by GE Medical Systems
Information Technologies, a General Electric Company going to market as
GE Healthcare. All other marks are owned by their respective owners.

INTENDED AUDIENCE

The MAC 400 Resting ECG Analysis System Guides are intended for
persons who use, maintain, or troubleshoot this equipment.

REVISION HISTORY

The document part number and revision letter are on the bottom of each
page. The revision letter identifies the document’s update level.

Revision History 2032589-001

Revision Date Comment

A 15 May 2007 Initial release of document

B 15 June 2007 Revised per MVP feedback

C 16 July 2007 Revised IPD

D 11 September 2007 Revised heading.

E 17 March 2008 Updated “Equipment Symbols”.

PRODUCT REFERENCE

The product described in these guides is the MAC 400 resting ECG
analysis system. It may be referred to as “the system” throughout these
documents.

CONVENTIONS

These conventions are used in the MAC 400 system guides:

Bold text Indicates keys on the keyboard, text to be entered, or

hardware items such as keys or switches on the
equipment.

Italicized text Indicates terms that identify menu items or options in the

system display window.

CE marking information

The MAC 400 system bears the CE mark “CE-0459”, notified body
GMED, 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 system delivers 3-channel
ECG recordings in automatic and arrhythmia modes and 1 or 3-channel
ECG recordings in manual mode. The country of manufacture can be found
on the equipment labeling.
The safety and effectiveness of this device have been verified against
previously distributed devices. All standards applicable to presently
marketed devices may not be appropriate for prior devices (for example,
electromagnetic compatibility standards). This device will not impair the
safe and effective use of previously distributed devices.

NOTE: Electromagnetic compatibility information can be found in the
“MAC™ 400 Resting ECG Analysis System Service Manual”.

Product use and classification

RECOMMENDATIONS

Operating the system near radio frequency (RF) electromagnetic
interference (EMI) above the conditions defined in the electromagnetic
compatibility (EMC) Standard EN60601-1-2 for Radiated Immunity (field
strengths above 3 volts per meter) may cause waveform distortions.
Portable and mobile RF communications equipment can affect medical
electrical equipment. Users should consider RF sources, such as radio or
TV stations and hand-held or mobile two-way radios, when installing a
medical device or system. Adding accessories or components, or
modifying the medical device or system may degrade the EMI
performance. Consult with qualified personnel regarding changes to the
system configuration.
Medical electrical equipment requires precautions regarding EMC and
needs to be installed and used according to the EMC information provided
in the product service manual. The use of accessories, transducers and
cables other than those specified or sold by the manufacturer may result in
increased emissions or decreased immunity of the system. The system
should not be used nearby or stacked with other equipment. If stacking or
using near other equipment cannot be avoided, observe to verify normal
operation. Review the AAMI Committee Technical Information Report
(TIR) 18, “Guidance on Electromagnetic Compatibility of Medical
Devices for Clinical/Biomedical Engineers” for details on evaluating and
managing an EMI environment in the hospital. Take the following actions
to reduce the risk of medical device EMI and achieve EMC:

• Assess the EMC environment of the facility and identify radio
transmitters and/or areas where critical medical devices are used
such as the emergency room and intensive care units.

• Increase the distance between sources of EMI and susceptible
devices.

• Remove the devices that are highly susceptible to EMI.

• Lower the power transmitted from electrical and electronic
equipment (EMI sources) under hospital control (i.e. paging
systems).

• Label devices susceptible to EMI.

• Educate facility staff (nurses and doctors) to identify, and
recognize, potential EMI-related problems.

CLASSIFICATION

The device is classified, according to IEC 60601-1, as:

Type of protection against
electrical shock

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, oxygen or
nitrous oxide

Methods of sterilization or
disinfection recommended
by the manufacturer

Mode of operation Continuous operation.

Class I or internally powered equipment.

Type CF defibrillation-proof applied part.

Ordinary equipment (enclosed equipment
without protection against ingress of water,
IPX0).

Equipment not suitable for use in the presence
of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.

Not applicable.

RESPONSIBILITY OF THE MANUFACTURER

GE is responsible for the effects of safety, reliability, and performance only
if:

• Assembly operations, extensions, readjustments, modifications, or
repairs are carried out by persons authorized by GE.

• The electrical installation of the relevant room complies with the
requirements of the appropriate regulations.

• The equipment is used in accordance with the instructions for use.

INTENDED USE

The MAC 400 device is for use under the direct supervision of a licensed
healthcare practitioner. The system is intended to acquire, measure and
record information from adult and pediatric populations. The basic system
delivers 3-channel ECG recordings in automatic and arrhythmia modes and
1 or 3-channel ECG recordings in manual mode. The arrhythmia detection
provides the convenience of automatic documentation. It is not designed to
provide alarms for arrhythmia detection. This system is not intended for
use as a vital signs physiological monitor, or for use during patient
transport.
This device is not intended for use with high frequency surgical units.
Disconnect the patient from the device before using the high frequency
surgical units. This device is not intended for use with direct cardiac
applications.

BIOCOMPATIBILITY

The parts of the product described in these guides, including all
accessories, that come in contact with the patient during the intended use,
fulfill the biocompatibility requirements of the applicable standards. Please
contact GE or its representatives with any questions.

Safety information

DEFINITIONS

The terms danger, warning, and caution are used in these guides to point
out hazards and to designate a degree or level of seriousness. Familiarize
yourself with their definitions and significance. A hazard is defined as a
source of potential injury to a person.

DANGER indicates an imminent hazard which, if not avoided, will
result in death or serious injury.
WARNING indicates a potential hazard or unsafe practice which, if
not avoided, could result in death or serious injury.

CAUTION indicates a potential hazard or unsafe practice which, if not
avoided, could result in personal injury or product/property damage.

NOTE provides application tips or other useful information to ensure
that you get the most from your equipment.

The safety information given in this manual is classified as follows.

Warning Description

Accidental spills To avoid electric shock or device malfunction, liquids

must not enter the device.
If liquids enter the device, stop using it and have it
checked by a service technician before further use.

Battery
operation

Cables To avoid possible strangulation, route all cables away

Connection to
mains

If the integrity of the protective earth conductor is in
doubt, operate the unit from its battery.

from patient's throat.

This is Class I equipment. The mains plug must be
connected to an appropriate power supply.

Warning Description

Defibrillator
precautions

Electrodes Polarizing electrodes (stainless steel or silver

Magnetic and
electrical
interference

Explosion
hazard

Interpretation
hazard

Operator Medical technical equipment such as this

Shock hazard Improper use of this device presents a shock hazard.

Site
requirements

Do not come into contact with patients during
defibrillation. Serious injury or death could result. Patient
signal inputs labeled with the CF and BF symbols with
paddles are protected against damage resulting from
defibrillation voltages. To ensure proper defibrillator
protection, use only the recommended cables and lead
wires. Proper placement of defibrillator paddles in
relation to the electrodes is required to ensure successful
defibrillation.

constructed) may cause the electrodes to retain a residual
charge after defibrillation. A residual charge will block
acquisition of the ECG signal. Whenever patient
defibrillation is a possibility, use nonpolarizing (silver/
silver chloride construction) electrodes for ECG
monitoring.

Magnetic and electrical fields can interfere with proper
performance of the device. Make sure that all external
devices operated near the device comply with the relevant
EMC requirements.
X-ray equipment or MRI devices may interfere with
system performance because they may emit higher levels
of electromagnetic radiation.

Do NOT use in the presence of flammable anesthetics
vapors or liquids.

Computerized interpretation is only significant when
used in conjunction with clinical findings. A qualified
physician must over read all computer generated tracings.

electrocardiograph system must only be used by persons
who have received adequate training in the use of such
equipment and are capable of applying it properly.

Failure to observe the following warnings may endanger
the lives of the patient, the user, and bystanders.
Disconnect from the power source before disconnecting
the cable from the device to reduce the risk of
inadvertently introducing metal parts in the sockets of the
power cord and coming in contact with line voltage.

Do not route cables in a way that they may present a
stumbling hazard. For safety reasons, connectors for
patient cables and lead wires are designed to prevent
disconnection if pulled on. For devices installed above
the patient, adequate precautions must be taken to prevent
them from dropping on the patient.

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MAC™ 400 Resting ECG Analysis System Safety and Warnings Guide

© 2007, 2008 General Electric Company. All Rights Reserved

Caution Description

Accessories
(supplies)

Proper lead wire
connection

Before installation Compatibility is critical to safe and effective use of

Disposables Disposable devices are intended for single use only.

Equipment damage Devices intended for emergency application must not

Electric shock To reduce the risk of electric shock, do NOT remove

Power
requirements

Low battery shut
down

Serviceable parts This equipment contains no user serviceable parts.

Supervised use This equipment is intended for use under the direct

To ensure patient safety, use only parts and accessories
manufactured or recommended by GE. Parts and
accessories must meet the requirements of the
applicable IEC 60601 series safety standards and
essential performance standards.

Improper connection will cause inaccuracies in the
ECG. Trace each individual lead wire from its
acquisition module label to the colored connector and
then to the proper electrode to ensure that it is matched
to the correct label location.

this device. Please contact your local sales or service
representative prior to installation to verify equipment
compatibility.

Do NOT reuse, as performance may degrade or
contamination could occur.

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.

cover (or back). Refer servicing to qualified personnel.

Before connecting the device to the power line, check
that the voltage and frequency ratings of the power
line are the same as those indicated on the unit's label.
If not, do not connect the system to the power line.
This equipment is suitable for connection to public
mains as defined in CISPR 11.

If the battery is not charged for a long enough period
of time or after multiple attempts to power on
following a low-battery shut down, the system shifts
to a second level of deep discharge protection. If
device is turned on, it might call for a 1 to 2 minute
continuous self test. Charge the battery for a minimum
of half an hour before using device. We recommend
that you keep the unit charged to avoid a low-battery
shut down.

Refer servicing to qualified service personnel.

supervision of a licensed healthcare practitioner.

General information

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. 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. Electrode polarization blocks acquisition of the ECG signal.
If a defibrillation procedure is necessary, use non-polarizing electrodes,
such as silver/silver-chloride types, to avoid a DC offset voltage when
subjected to a DC current. If using polarizing electrodes, disconnect the
lead wires from the patient before delivering the shock. Electrode
defibrillation recovery allows the ECG trace to return after defibrillation.
We recommend using nonpolarizing disposable electrodes with
defibrillation recovery ratings as specified in AAMI EC12 3.2.2.4. (MMS
P/N 9623-103P Silver Mactrodes™, MMS spec. TP9623-003). AAMI
EC12 requires that the polarization potential of an electrode pair does not
exceed 100 mV, five seconds after a defibrillation discharge.

RECORDING ECGS OF PACEMAKER PATIENTS

The system does not support pacer pulse detection.

WARNING: PATIENT HAZARD — If several adverse conditions

exist at once, pacer pulses might be interpreted and counted as QRS
complexes. Pacemaker patients should always be watched closely.

ACCURACY OF THE INPUT SIGNAL REPRODUCTION

• Overall system error is tested using the method described in AAMI
EC11 3.2.7.1. Overall system error is %.

• Frequency response is tested using the method described in AAMI
EC11 3.2.7.2 methods A and D.

MODULATING EFFECTS IN DIGITAL SYSTEMS

This device uses digital sampling techniques that may produce some
variation in amplitudes of Q, R, and/or S waves from one heart beat to the
next. These variations may occur more in pediatric recordings. If this
variation is observed, be aware that the origin of amplitude variations is not
entirely physiologic. For measuring voltages of Q, R, and S waves, use the
QRS complexes with the largest deflection of the particular waves.

PARTS AND ACCESSORIES

To ensure patient safety, use only parts and accessories manufactured or
recommended by GE. Parts and accessories must meet the requirements of
the applicable IEC 60601 series safety standards and essential performance
standards.

5±

EQUIPMENT SYMBOLS

Symbol Description/Function

Type CF equipment. The acquisition module is protected
from defibrillation shocks.

The flashing yellow LED indicates you must connect to AC
power to re-charge the battery.

Consult instructions for use.

Consult accompanying documents for cautions.

Classified with respect to electric shock, fire, mechanical, and
other specified hazards only in accordance with UL 60601-1,
CAN/CSA C22.2
No. 601.1, EN 60601-2-25, EN 60601-1, IEC 60601-1-2:
2001, IEC 60601-2-51.

Indicates that the device is classified as Ordinary Equipment
(enclosed equipment without protection against ingress of
water).

Indicates that the waste of electrical and electronic equipment
must not be disposed as unsorted municipal waste and must
be collected separately. Please contact an authorized
representative of the manufacturer for information concerning
the decommissioning of your equipment.

Fuse.

Do not throw or dispose of in fire!

Contains "Lithium Ion". This symbol indicates "General
recovery/recyclable" and must not be disposed of as unsorted
municipal waste and must be collected separately.

Manufacturer name and address.

Date of Manufacture (Year-Month).

Batch code of paper or battery.

Symbol Description/Function

Serial number.

European authorized representative.

The packaging of this product can be recycled.

Humidity limitation.

Atmospheric pressure limitation.

Environment-friendly Use Period per Chinese standard SJ/
T11363-2006 (China specific).

PCT. GOST marking symbolizing conformity with applicable
Russian Gosstandart technical and safety standards.

SERVICE REQUIREMENTS

Refer equipment servicing to GE authorized service personnel only. 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
or an authorized agent.

EQUIPMENT IDENTIFICATION

Every GE device has a unique serial number for identification on the
device label.

A Product code is SCT

B

C Fiscal week manufactured

D Production sequence number

E Manufacturing site

F Miscellaneous characteristic

Year manufactured (00-99)
00 = 2000, 01 = 2001, and so on

Catalogue number (Part number).

g

GE Medical Systems

Information
Technologies, Inc.

8200 West Tower
Avenue
Milwaukee, WI 53223 USA
Tel: + 1414 355 5000
1 800 558 5120 (US only)
Fax: + 1414 355 3790

www.gehealthcare.com

GE Medical Systems
Information Technologies
GmbH
Munzinger Strabe 3-5
D-79111 Freiburg
Germany
Tel: + 49 761 4543 - 0
Fax: + 49 761 4543 - 233

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Asian Headquarters
GE Medical Systems
Information Technologies Asia;
GE (China) Co., Ltd.
11th Floor Shanghai MAXDO
Centre
8 Xing Yi Road, Hong Qiao
Development Zone
Shanghai 200336, People’s
Republic of China
Tel: + 86-21-5257-4650

MAC™ 400 Resting ECG Analysis System Installation and Setup Guide

© 2007, 2008 General Electric Company. All rights reserved.

The MAC™ 400 Resting ECG Analysis System Installation and Setup
Guide provides instructions for initial installation and setup of your

system.

Before you begin

Remove the device and accessories from the box, and keep on a flat dry
surface, away from direct sunlight, heat sources & dust.

A. Confirming the box contents

• MAC 400 resting ECG analysis device

• Four limb clamp electrodes

• Six bulb electrodes

• Patient ECG cables/lead wires

• Power cable

• Pack of z-fold paper (280 sheets)

• Electrode cream

• CD containing a service manual and 12SL™ Physicians Guide

• User guide

B. Charging the battery

The MAC 400 system needs a charged battery to print an ECG. Charge
the battery for three hours for full power. A fully charged battery
allows for 100 automatic mode ECGs or 100 minutes of arrhythmia/
manual mode recording.

1. Connect the device to a power source.

2. Turn on the power (a green light indicates that AC mains is
connected).

3. After charging for three hours, unplug the power cord from
both the device and the power source.

Recharge when you see a yellow light above the power key.

C. Loading paper

The MAC 400 system supports the use of standard thermal recording
paper in either z-fold pads or roll paper.

1. Locate the printer assembly.

2. Gently pull back the printer assembly door to open the door
latch.

A red line at the top of the last ten sheets indicates that the paper
supply is low. Change paper as needed.

NOTE: For instructions on loading roll paper, see the
“MAC™ 400 Resting ECG Analysis System Maintenance
Guide”.

Initial system setup

THE SETUP MENU

Press on/off to turn on the device, and then, press

configuration to access the setup menu. Use the setup menu to
navigate between system settings and select the options you want. For
more information, see System Symbols and System Menu Descriptions
on page 4.

THE SYSTEM PARAMETERS TOOLS

Use these tools and guidelines to help you define the operating parameters.

1. Use up/down cursor to select a menu item.

2. Use right/left cursor to select the desired setting.

3. Always press enter to confirm your selection.

4. Always press configuration to save and exit the

setup menu.

SETTING OPTIONS FOR INITIAL USE

A. Selecting a language

Different languages are available for the display text and printed ECG
reports.

1. Press configuration to display the language selection

menu.

2. Use the right/left cursor to select the language.

3. Press enter to confirm your selection.

B. Selecting the lead notations

There are two different lead notation options: AHA and IEC.

1. Use the up/down cursor to select Notation.

2. Use the right/left cursor to select AHA or IEC.

2. Use the right/left cursor to set the date.

3. Press enter to confirm your selection.

To set the time:

1. Use the up/down cursor to select Time.

2. Use the right/left cursor to set the time.

3. Press enter to confirm your selection.

D. Selecting heart rate limit values

1. Use the up/down cursor to select HR control. The

cursor flashes on the low limit value.

2. Use the right/left cursor to change the low limit

value, in increments of 5 BPM, between 30 and 120 BPM.

3. Press enter to confirm your selection.

4. Use right/left cursor, change the high-limit value

(between 80 and 240 BPM).

5. Press enter to confirm.

NOTE: After setting these options, you must press

configuration to save the options and exit the setup menu.

Heart rate indication

THE BASICS

WARNING PATIENT HAZARD — The MAC 400 system is not

intended for use as a vital signs physiological monitor. When needed,
use a device intended for vital signs monitoring.

When the heart rate indication function is enabled, the automatic switchoff
is disabled. Conditions of high and low heart rate are indicated in all
operating modes, even when not recording. This function can be disabled
in the setup menu. The default heart rate limits are 45 and 130 BPM, and
can be modified in the setup menu. If the heart rate exceeds one of the set
values, the system emits an audio signal. This audio signal ceases
automatically when the heart rate returns to the permitted range or when

you press QRS beep. The audio signal will not recur if it was

silenced with QRS beep. The audio signal recurs only when the

heart rate exceeds one of the limit values again.

E. Hooking up the starter kit

Once you have customized your settings, connect the patient cable to
the device (A) on the right side panel.

Default settings for auto mode

When you turn on the device, the system default is automatic mode.
Factory defaults have the following functions and settings (the most
important settings are indicated on the display):

A

BC

J

I

H

Lead sequence: Standard = Einthoven (I, II, III),

A

Goldberger(aVR, aVL, aVF), Wilson 1 (V1, V2,
V3), Wilson 2 (V4, V5, V6).

Lead fail indicator: Indicates a disconnected

B

electrode. For example, LA indicates that the left
arm electrode is disconnected.

C

D

QRS indicator: The heart symbol blinks with every
detected systole.

Heart rate: Detects the patient’s heart rate. In this
example, it is 60 BPM.

E AC filter: On (enabled) (50 Hz).
F Muscle filter: Off (disabled).
G Sensitivity (gain): 10 mm/mV.
H Paper speed: 25 mm/s.

Rotating symbol: Displays when the ECG data

I

acquisition or recording is active.

J Operating mode: Automatic.

E

D

F

G

3. Open the z-fold paper pack.

4. Ensure that the black paper guide is on the top and place the
paper in the tray.

5. Advance the first sheet and close the door. Make sure that
the paper is positioned on the pressure roller and that the
door locks into place on both sides.

3. Press enter to confirm your selection.

C. Setting the date and time

Set the date and time for printed ECG reports.
To set the date:

1. Use the up/down cursor to select Date.

Additional default settings (not indicated on the display):

• Notation: AHA.

• ADS: Enabled.

• Report format: Simultaneous, short.

• Override: Disabled.

NOTE: For further descriptions of the settings, see System Menu
Descriptions on page 4.

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