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GE Healthcare

MAC™ 400
Resting ECG Analysis System
Version 1

Service Manual

2036039-001 Revision A
NOTE
The information in this manual applies to MAC™ 400 resting ECG analysis systems. Due to continuing product
innovation, specifications in this manual are subject to change without notice.

MUSE®, CASE®, MAC®, MARS®, and 12SL™ are trademarks owned by GE Medical Systems Information Technologies,
a General Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their
respective owners.

©2007 General Electric Company. All Rights reserved.

T-2 MAC™ 400 2036039-001A


02 July 2007
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
Manual information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Revision history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Manual purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Intended audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3


Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Safety messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Responsibility of the manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Equipment symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Service information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9


Equipment identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Serial number format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Label format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Product label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
CE marking information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13

2 Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1


General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Description of the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Mechanical structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Description of the functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6


Power supply module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Main PCB assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Internal interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

Preparation for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19


The Setup menu overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19
Setting options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20
Printing settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22
Restoring options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

Diagnostic tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23


Self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23
Device tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23

2036039-001A MAC™ 400 i


3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Recommended maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Required tools and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Inspections and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Exterior cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Interior cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Electrical safety tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Leakage current tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Earth leakage (AC line) current test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Enclosure (Chassis) leakage current test . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
Patient leakage current tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Patient leakage current to ground . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
Patient leakage current, Mains on applied part . . . . . . . . . . . . . . . . . . . . . . . .3-9

Replacing components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11


Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
Replacing the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
Replacing the primary fuses in the power inlet module . . . . . . . . . . . . . . . . . . . .3-13
Opening the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
Replacing the thermal printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
Replacing the display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16
Replacing the PCB assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16
Replacing the RTC battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
Replacing the OTPROM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19
Replacing the 12V power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20
Replacing the power inlet module along with the toroid assembly . . . . . . . . . . . .3-22
Adjustment instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

4 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
Device connected to mains but does not turn on . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Green LED does not light up and device does not turn on . . . . . . . . . . . . . . . . . . .4-2
Green LED lights up and device does not turn on . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Battery only connection and device does not turn on . . . . . . . . . . . . . . . . . . . . . . .4-4
Blank display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
Errors detected during self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
Errors detected during printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Battery error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Printer door open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
Paper problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
Paper is moving but not printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10
Data does not print on the upper or lower edges of paper . . . . . . . . . . . . . . . . . .4-11
Printing only baselines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

5 Parts List and Replacement . . . . . . . . . . . . . . . . . . . . . . . .5-1


Ordering parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

ii MAC™ 400 2036039-001A


Accessory kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Service manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Operator’s guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Power cords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Field replaceable units (FRUs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5

A Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . A-1

B Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . B-1


Guidance and manufacturer’s declaration- electromagnetic emissions . . . . . . . B-2

Guidance and manufacturer’s declaration-electromagnetic immunity . . . . . . . . . B-3

Recommended separation distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

2036039-001A MAC™ 400 iii


iv MAC™ 400 2036039-001A
1 Introduction

2036039-001A MAC™ 400 1-1


Introduction

Manual information
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. The
revision history of this document is summarized in “Table 1-1: Revision
history, PN 2036039-001” on page 1-2.

Table 1-1: Revision history, PN 2036039-001

Revision Date Comment

A 02 July 2007 Initial release of this document.

Manual purpose
This manual provides technical information for service representatives
and technical personnel so they can maintain the equipment to the
assembly level. It serves as a guide for maintenance and electrical
repairs that are considered field-repairable. Where necessary, the
manual identifies additional sources of relevant information and/or
technical assistance. See the operator guides for the instructions
necessary to operate the equipment safely in accordance with its function
and intended use.

Intended audience
This manual is intended for the person who maintains or troubleshoots
this equipment.

1-2 MAC™ 400 2036039-001A


Introduction

Conventions

Table 1-2: Conventions

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


hardware terms such as buttons or switches on the
equipment.

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

Safety information
Definitions
The terms Danger, Warning and Caution are used throughout this
manual to point out hazards and to designate a degree or level of
seriousness. Familiarize yourself with their definitions and significance.

Hazard is defined as a source of potential injury to a person.

Table 1-3: Hazard terms

Term Definition

DANGER Indicates an imminent hazard which, if not avoided, will


result in serious injury or death.

WARNING Indicates a potential hazard or unsafe practice which, if not


avoided, could result in serious injury or death.

CAUTION Indicates a potential hazard or unsafe practice which, if not


avoided, could result in minor personal injury or product/
property damage.

NOTE Provides application tips or other useful information to


assure that you get the most from your equipment.

Safety messages
Additional safety messages that provide appropriate operation
information may be found throughout this manual.

2036039-001A MAC™ 400 1-3


Introduction

DANGER
EXPLOSION HAZARD — Use near flammables may
cause explosion.

Do not use in the presence of flammable anesthetics,


vapors or liquids.

WARNING
CONNECTION TO MAINS — The mains plug must be
connected to an appropriate power supply.

Operate the unit from its battery if the integrity of the


protective earth conductor is in doubt.

Responsibility of the manufacturer


GE Medical Systems Information Technologies (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.

General
The intended use of this device is to record ECG signals from surface
ECG electrodes. This device can record, analyze and print
electrocardiographic information from adult and pediatric populations.

This device is intended for use under the direct supervision of a licensed
health care practitioner.

Failure on the part of the responsible individual, hospital, or institution


using this equipment to implement a satisfactory maintenance schedule
may cause undue equipment failure and possible health hazards.
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE.

Parts and accessories used must meet the requirements of the applicable
IEC 60601 series safety standards and essential performance standards.

1-4 MAC™ 400 2036039-001A


Introduction

The use of ACCESSORY equipment not complying with the equivalent


safety requirements of this equipment may lead to a reduced level of
safety. Consideration relating to the choice should 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 harmonized
national standard.

2036039-001A MAC™ 400 1-5


Introduction

Equipment symbols

Table 1-4: Equipment symbols

Symbol Description

Type CF equipment. The acquisition module is protected


from defibrillation shocks.

Battery symbol. The flashing yellow LED indicates that the


unit should be connected to AC power to re-charge the
battery.

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.

Instructions symbol. Consult instructions for use.

CAUTION: Consult accompanying documents.

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


(or back). Refer servicing to qualified personnel.

Indicates that the device is classified as Ordinary


Equipment (enclosed equipment without protection against
ingress of water).

1-6 MAC™ 400 2036039-001A


Introduction

Table 1-4: Equipment symbols

Symbol Description

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.

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.

Fuse.

Manufacturer name and address.

Date of manufacturer in the format YYYY-MM.

Batch code of paper or battery.

2036039-001A MAC™ 400 1-7


Introduction

Table 1-4: Equipment symbols

Symbol Description

Catalogue number (Part number).

Serial number.

Heart rate in beats per minute (BPM).

Lead fail indicator.

Power key. Press to turn device on/off.

Start/Stop key. Press to start and stop recording.

Lead selection key. Press to change the ECG lead/leads.


The key is only enabled when a patient cable is connected.

Copy key. Press to print additional report copies.

1-8 MAC™ 400 2036039-001A


Introduction

Table 1-4: Equipment symbols

Symbol Description

QRS beep key. Press to enable/disable QRS beep and


audio signals alerting to specific events, and to clear the
error message.

Configuration key. Press to access/quit the setup menu.

Cursor control key. Press to move the cursor up, down,


right or left to select menu items and change settings.

Enter key (center of cursor control keys). Press to confirm


selections during device configuration.

Environment-friendly Use Period per Chinese standard SJ/


T11363-2006. (China specific)

CE Marking.

Service information
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 to one of their authorized agents.

2036039-001A MAC™ 400 1-9


Introduction

Equipment identification

025
Every GE device has a unique serial number for identification. The serial
number is formatted as shown in the following section.

NOTE
The examples shown below are representative only. Your product
label may vary.

Serial number format

026

1-10 MAC™ 400 2036039-001A


Introduction

Table 1-4: Serial number description

Section Description

A Product Code for MAC 400

B Year of manufacture

C Fiscal week of manufacture

D Production sequence number

E Manufacturing site code


F Miscellaneous characteristic

This manual applies to MAC 400 with product code SCT.

Label format

027

Table 1-5: Label format

Section Description

A Date of manufacture in the format YYYY-MM


B Part number of product

C Product code description

D Serial number described above

E Barcode representation of serial number

2036039-001A MAC™ 400 1-11


Introduction

Product label
The product label is located on the rear side of the device next to the
power inlet module.

028

Table 1-6: Product label

Section Description

A Product name (MAC 400)

B Site of manufacture
C Rating of 12V power supply

D Dimension and rating of fuse

E 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.

F Consult instructions for use

G CAUTION: Consult accompanying documents

H CE marking

I 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.

1-12 MAC™ 400 2036039-001A


Introduction

CE marking information
The MAC 400 device bears CE mark 0459 indicating its conformity with
the provisions of the Council Directive 93/42/EEC concerning medical
devices and fulfills the essential requirements of Annex I of this
directive. The product is in radio-interference protection class A in
accordance with EN 55011.The country of manufacture can be found on
the equipment labeling. The product complies with the requirements of
standard EN 60601-1-2 “Electromagnetic Compatibility - Medical
Electrical Equipment”.

EMC: immunity performance


Users should be aware of known RF sources, such as radio or TV stations
and hand-held or mobile two-way radios, and consider them when
installing a medical device or system. 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.

Configuration of instrument part number


There are two instrument part numbers associated with the MAC 400
device. The language is determined at the configuration centers and
there are no language-specific variants.

Table 1-7: Instrument part numbers

Instrument Part
Description
Number

2033547-001 MAC 400 resting ECG analysis system, 3-channel electrocardiograph for mains and battery
operation with measurement feature

2033547-002 MAC 400 resting ECG analysis system, 3-channel electrocardiograph for mains and battery
operation with measurement and interpretation feature

2036039-001A MAC™ 400 1-13


Introduction

1-14 MAC™ 400 2036039-001A


2 Equipment Overview

2036039-001A MAC™ 400 2-1


Equipment Overview

General description
The MAC 400 resting ECG analysis system is a 12-lead, 3-channel
system with a 2 line x 16 character display, passive patient cable and
battery operation.

Top view

029

Table 2-1: Top view

Name Description

A Keyboard Press the keyboard keys to power on the system,


change operating parameters or control
operations.

B Display View lead/lead group, heart rate, mode of


operation, speed, gain, and filter settings.

2-2 MAC™ 400 resting ECG analysis system Revision A


2036039-001
Equipment Overview

Side view

030

Table 2-2: Side view

Name Description

A ECG signal input connector Connect the patient cable.

Revision A MAC™ 400 resting ECG analysis system 2-3


2036039-001
Equipment Overview

Rear view

031

Table 2-3: Rear view

Name Description

A Product label Displays product name, site of manufacture,


power supply specification, fuse specification
and relevant symbols.

B AC mains connector Connect the power cord to charge the battery.

Description of the device


The MAC 400 resting ECG analysis system is a portable
electrocardiograph with an integrated thermal printer and motor
assembly. It is designed to acquire, process and record ECG signals. This
manual describes the version 1 of the software. A power supply unit and
battery are integrated into the device. It is designed primarily for
operating from the battery power source, and the print function only

2-4 MAC™ 400 resting ECG analysis system Revision A


2036039-001
Equipment Overview

works on battery power. The battery is a Lithium-Ion rechargeable


battery, and charges when the device is connected to mains.

The hardware consists of the following:

„ Power block
„ Battery detection circuit
„ Battery low indication circuit
„ Keyboard interface
„ Thermal printer and motor assembly interface
„ Display interface
„ Clocks
„ PCB assembly
„ CPU
„ Strobe compensation circuit
„ VCC monitor
„ Memory block
„ Over-temperature detection circuit
„ Thermal printer voltage VTPH control
„ Field-programmable gate array (FPGA)
„ Audible tone generator
The intended use, available functions and operation of the MAC 400
system are described in the operator’s guides.

Mechanical structure
The major mechanical components of the MAC 400 device are the top and
bottom covers. The bottom cover is the basic element housing the
following sub-assemblies:

„ Power inlet module with fuses


„ Aluminum plate with a power supply module and toroid assembly on
the bottom and the PCB assembly on the top. The display, the
keyboard connector, printer connector and patient cable connector
are mounted to the PCB assembly
„ Battery pocket, battery cover and battery
„ Thermal printer and motor assembly
„ Paper pocket, paper lifting tape, and printer door
The top cover houses the display window, paper cutter and keyboard,
which is linked to the main PCB assembly via a flexible cable.

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Description of the functionality


The following block diagram details the main PCB assembly containing
all of the circuitry for the MAC 400 resting ECG analysis system. The
power line supply, battery, thermal printer, keyboard and display are not
on the main PCB assembly. The PCB assembly is divided in to two
sections—isolated and non-isolated.
The patient is directly connected to the isolated section of the device with
the patient cable. This section of the device is electrically isolated from
the mains power supply that is connected to the non-isolated section. The
circuitry on the isolated side acquires ECG data, amplifies it and
converts it to digital format. Then, the line frequency component and the
muscle artifacts from the ECG data are filtered, and opto-couplers
transmit the digitized ECG data from the isolated side to the non-
isolated side. The transformer transfers power from the non-isolated side
to the isolated side.
The circuitry on the non-isolated section processes, analyses and
interprets digitized ECG data. The non-isolated section interfaces with
the keyboard, display and thermal printer.

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Power supply module


The power supply module is mounted on the aluminum plate on the
bottom cover. The power supply module is comprised of the power inlet
and +12V power supply.

Power inlet
The power inlet includes a three-pin IEC plug and fuse holder for two 2-
pole 5x20mm fuse links. This system inlet has a snap fitting.

+12V power supply


The AC/DC power supply is a customized module designed for a
universal range of input voltages. The output supply is in the range of
12V +/- 2%. The specifications of the power supply are outlined in “Table
2-4: Power supply specifications” on page 2-8.

Table 2-4: Power supply specifications

Input voltage range 100-240V AC


Frequency 50-60Hz

Full load current 1.67A

Output voltage 12V

Line regulation 12V +/-0.5%

Load regulation 12V +/-2%

Battery
A customized, rechargeable Lithium-Ion battery with built-in 2S
protection is mounted to the battery pocket in the bottom cover. A
dedicated battery charger is used to charge the battery. The battery
specifications are listed in “Table 2-5: Battery specifications” on page 2-8.

Table 2-5: Battery specifications

Rated voltage 7.2V

Battery voltage 5.4-8.4V

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The MAC 400 system can print only when the battery is connected to the
device. With a fully charged battery (8.3-8.4V), approximately 100 ECGs
can be recorded in auto mode.

NOTE
If the device cannot produce at least fifty ten-second ECG reports
sequentially on a fully charged battery, we recommend replacing the
battery. For instructions on replacing the battery, see “Replacing the
battery” on page 3-12.

Main PCB assembly


The MAC 400 system’s main PCB assembly contains all the circuitry for
the device except the power supply line, battery, thermal printer,
keyboard and display. The circuitry can be grouped by functionality.

Voltage supply and monitoring


The device requires several regulated voltages for operation of its various
components. Voltage supply and monitoring includes on/off electronics,
5V DC-DC converter, +3.3V LDO and battery charger.

On/off electronics turn the device power on and off. The input voltage
monitoring circuit monitors the battery voltage. A yellow LED on the
keyboard indicates when it falls below 6.8V +/- 2%. If the voltage falls
below 6.3V +/- 2%, the unit turns off automatically.

The output of the power supply is connected to an SMD2016 polyfuse


resettable 1.5A fuse for over-current protection.

A Lithium-Ion charge management IC charges the battery when the


device is connected to mains. +12V is the input to the battery charger.
LED DS1 and DS2 (shown in the component view in the following
graphic) as outlined in “Table 2-6: Charging conditions” on page 2-10
indicate the charging conditions.

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Table 2-6: Charging conditions

Charger operation DS2 DS1

Charge in progress ON OFF

Charge complete OFF ON

Charge suspend, timer fault, over voltage, sleep mode, batter OFF OFF
absent

CPU Motorola MC68832


The Motorola MC68832 (CPU) 32-bit micro controller is the core of the
MAC 400 resting ECG analysis system. The CPU interacts with SRAM,
PROM, EEPROM, RTC, FPGA, thermal printer interface, keyboard
interface, display interface, audible tone and DSP (isolated side). A
32.768KHz crystal provides the reference clock signal for the clock
synthesizer of the CPU.

Memory
Memory on the MAC 400 system includes SRAM, PROM, and Serial
EEPROM. PROM stores the code for the CPU and serial EEPROM stores
configuration data.

Real-time clock (RTC)


The RTC4574 has an internal 32.768KHz crystal unit. Serial
communication between CPU and RTC4574 through the I/O port of the
CPU is used to exchange time and date information between the CPU
and RTC. RTC has an accuracy of +/- one minute per month. When the

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device is turned off, the RTC battery powers the RTC to keep track of the
time and date. The battery is a 3V Lithium Ion coin battery with
255mAH capacity, which can supply power to the clock for a minimum of
five years.

Audible tone (beep) generator


The audible tone generator is F/TCW 05 manufactured by DIGISOUND.
The CPU controls the beep by enabling it under the following
circumstances:

„ The beep sounds once when the self-test is complete.


„ The beep sounds once every five seconds when the leads are not
connected.
„ The beep sounds once every five seconds to indicate the printer door
open, battery and paper error conditions.
„ The beep sounds once for every QRS peak detected when the heart
rate is within the specified limits.
NOTE
Pressing the QRS beep key disables the audible tone. Turning off the
QRS beep in configuration settings also disables the audible tone for
QRS complex.

Keyboard
The keyboard contains the following control keys: up cursor, down
cursor, right cursor, left cursor, enter, config, lead selection,
copy, QRS beep, print start/stop. The on/off key is not part of the
matrix.

There are two LEDs on the keyboard: the green LED indicates that the
system is connected to active mains. The yellow LED indicates that the
battery voltage is below 6.8V +/- 2%.

Display
The alphanumeric interface displays on a 16X2 character liquid-crystal
display powered by +5V supply. The character format is 5X7 dots plus
the cursor, and the viewing angle is six o’clock. The display type is a
reflective green STN.

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FPGA
The CPU-thermal printer interface, CPU-display enable logic, CPU-
motor driver IC interface are all implemented in FPGA. The CLKOUT
signal is the clock signal for logic implemented and has an output
frequency of 16.7MHz.

Thermal printer and motor assembly interface


The device is equipped with a Fujitsu thermal printer and motor
assembly with 576 dots, thermistor for thermal printhead temperature,
paper cue sensor and door platen sensor. There is a serial data interface
between the thermal printer and the FPGA. The strobe compensation
circuit modulates the strobe pulse width in accordance with battery
voltage, speed and temperature of the thermal printhead. The strobe
pulse width decides the time for which the dots are heated. The voltage
supply to the printhead and motor is cut off when the battery voltage
falls below 6V and the thermal printhead is overheated, or by the CPU
control in case of error conditions. The motor is a bipolar stepper powered
by an IC driver that moves the paper at speeds of 5, 25 or 50mm/s.

ECG recording and pre-processing


The ECG acquisition side is isolated from the non-isolated side by 8mm
of separation. There is no electrical conduction path between the isolated
and non-isolated sections, except a 68M-ohm resistor provided as a path
for the leakage current. Opto-couplers provide communication between
the CPU and DSP. The transformer provides magnetic coupling between
non-isolated +5V supply and +5V_ISO and +3.3V_ISO for power
transfer. The main components of the isolated side are:

„ ECG lead connector


„ Electrostatic discharge protection and conductive noise immunity
„ Probe ID circuit
„ Lead fail bias circuit
„ Right leg drive circuit
„ Instrumentation amplifiers
„ Multiplexer
„ ADC
„ Voltage reference
„ DSP
„ Serial EEPROM

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„ Clocks
„ Opto-couplers
„ Transformer
„ +5V_ISO
„ +3.3V_ISO
„ +1.8V
A step-up transformer is used to transfer power from the non-isolated
side to the isolated side. The voltages generated on the acquisition side
are +5V_ISO, +3.3V_ISO and +1.8V. Communication between DSP and
CPU follows SPI protocol by transmitting signals optically using Opto-
couplers.

Connector J1 connects the ECG leads to the MAC 400 system. The
system supports 10 leadwire ECG cables. The IEC convention is followed
in naming the leads: LL, LA, RA, RL, V1, V2, V3, V4, V5 and V6. Diodes
connected in series offer electrostatic discharge protection. A probe ID
circuit detects whether the cable is connected. A lead-fail bias circuit
detects when a particular lead is not connected. The right leg drive
circuit generates the reference signal for all the leads. Instrumentation
amplifiers provide the required gain. An 8:1 multiplexer selects the eight
channels one by one. The ADC samples each sample and sends the
digitized data to CPU. The signal chain in DSP includes notch filter, DC
filter, low pass filter, down sampling and line frequency filter. Serial
EEPROM is used to store DSP code. A 20MHz external crystal provides
the reference clock signal to DSP.

Internal interfaces
This section describes the interface signals between the PCB assembly
and external modules.

Signal flows between 12V power supply and PCB assembly


J10 is a 4-pin horizontal snap-fit connector and connects a 12V power
supply to the PCB assembly. The mechanical structure of the connector
does not allow reverse connection of the power supply to the PCB. The
connector signals are identified in “Table 2-7: J10 connector signals” on
page 2-14. Input output I/O is with respect to the MAC 400 system PCB.

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Table 2-7: J10 connector signals

Connector Signal Name I/O

J10-1 GND I
J10-2 GND I

J10-3 +12V I

J10-4 +12V I

Signal flow between battery and PCB assembly


J11 is a compression connector that connects the battery to the PCB. See
“Table 2-8: J11 interface signals” on page 2-14 for details.

Table 2-8: J11 interface signals

Connector Signal Name I/O

J11-1 VBAT + I

J11-2 VBAT + I

J11-3 VBAT - I

J11-4 VBAT - I

Signal flow between display and PCB assembly


J8 connects the display to the PCB. “Table 2-9: J8 connector signals” on
page 2-14 identifies the signals involved in the interface between the
display and the PCB.

Table 2-9: J8 connector signals

Connector Pin Function Description Level/Polarity

J8-1 GND Ground pin of display 0V

J8-2 +5V VCC of display 5V

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Table 2-9: J8 connector signals

Connector Pin Function Description Level/Polarity

J8-3 CONTRAST CPU generates this signal as a PWM 0-2V


wave integrated by a low pass filter to DC
voltage in the range of 0-2V

J8-4 ADR [0] This is the LSB of the address bus. It is TTL/active high
used to select between data and
instruction register

J8-5 R/W* CPU generates R/W* signal. This signal TTL/active high
decides whether data is read from the
display or written into the display

J8-6 DISPLAY The display enable signal generated by 3.3V/active high


CPU and further processed by FPGA
logic

J8-7 DATA [8] Part of the 16-bit bidirectional data bus

J8-8 DATA [9] Part of the 16-bit bidirectional data bus

J8-9 DATA [10] Part of the 16-bit bidirectional data bus

J8-10 DATA [11] Part of the 16-bit bidirectional data bus

J8-11 DATA [12] Part of the 16-bit bidirectional data bus

J8-12 DATA [13] Part of the 16-bit bidirectional data bus

J8-13 DATA [14] Part of the 16-bit bidirectional data bus

J8-14 DATA [15] Part of the 16-bit bidirectional data bus

J8-15 Unused This pin is not used


J8-16 Unused This pin is not used

Signal flow between thermal printer and PCB assembly


J7 is a positive lock 30-pin MOLEX connector, which connects the
thermal printer to the PCB. “Table 2-10: J7 connector symbols” on
page 2-16 defines the J7 connector symbols.

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Table 2-10: J7 connector symbols

Connector Pin Function I/O Description Level

J7-1 PHK I The cathode of LED in the cue mark 0-3.8V


sensor

J7-2 VSEN O The VCC of cue mark sensor and is 5V


equal to 5V

J7-3 VHE I The output of cue mark sensor 800mV-5V


connected to the input of the
comparator, which is part of the cue
mark sensor circuit

J7-4 SW I One terminal of the door sensor TTL/active high


input to door sensing circuit
J7-5 SW I Other terminal of door sensor 0V
connected to ground

J7-6 VH O Print head voltage supply 6-8.4V

J7-7 VH O Print head voltage supply 6-8.4V

J7-8 DI O Data input to shift register TTL

J7-9 CLK O Clock input to shift register TTL, L->H

J7-10 GND Ground 0V

J7-11 GND Ground 0V

J7-12 STB 5 O Strobe signal TTL, active high

J7-13 STB 4 O Strobe signal TTL, active high

J7-14 STB 3 O Strobe signal TTL, active high

J7-15 VDD O VCC for logic 5V

J7-16 TM I Thermistor
J7-17 STB 2 O Strobe signal TTL, active high

J7-18 STB 1 O Strobe signal TTL, active high

J7-19 AEO2 O Heater elements block select TTL, active low


J7-20 AEO1 O Heater elements block select TL, active low

J7-21 GND Ground 0V

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Table 2-10: J7 connector symbols

Connector Pin Function I/O Description Level

J7-22 GND Ground 0V

J7-23 LAT O Latch signal TTL, active low

J7-24 DO I Data out signal TTL


J7-25 VH O Print head voltage supply 6-8.4V

J7-26 VH O Print head voltage supply 6-8.4V

J7-27 MT A O One end of phase A winding 6-8.4V

J7-28 MT A* O Other end of phase A winding 6-8.4V

J7-29 MT B O One end of phase B winding 6-8.4V

J7-30 MT B* O Other end of phase B winding 6-8.4V

Signal flow between PCB assembly and keyboard


J9 is an 18-pin molex vertical mount connector that connects the
keyboard to the main PCB. Reverse voltage protection is implemented
mechanically. Interface signals between the keyboard and the PCB are
identified in “Table 2-11: J9 connector signals” on page 2-17.

Table 2-11: J9 connector signals

Connector Pin Function I/O Description Level

J9-1 GND Ground connection 0V

J9-2 Not connected

J9-3 Not connected

J9-4 GND Ground connection 0V

J9-5 On/Off switch I On/Off switch independent of matrix


J9-6 ROW1 I Row 1 connection

J9-7 ROW2 I Row 2 connection

J9-8 ROW3 I Row 3 connection

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Table 2-11: J9 connector signals

Connector Pin Function I/O Description Level

J9-9 ROW5 I Row 5 connection

J9-10 COLUMN5 O Column 5 connection

J9-11 COLUMN1 O Column 1 connection


J9-12 COLUMN2 O Column 2 connection

J9-13 ROW4 I Row 4 connection

J9-14 COLUMN3 O Column 3 connection

J9-15 COLUMN4 O Column 4 connection

J9-16 GND Ground connection 0V

J9-17 Main indication LED O Connected to the green LED which


lights up when a valid mains is
connected to the device

J9-18 Low Battery LED O Connected to the yellow LED which


lights up when the battery voltage
goes below 6.8V +/- 2%

ECG lead connector


J1 is a 14-pin connector, which connects ECG leads to the MAC 400
system PCB. The interface signals are identified in “Table 2-12: J1
interface signals” on page 2-18.

Table 2-12: J1 interface signals

Connector pin Function

J1-1 V2

J1-2 V3

J1-3 V4

J1-4 V5

J1-5 V6

J1-6 Cable shield

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Table 2-12: J1 interface signals

Connector pin Function

J1-7 Cable shield

J1-8 GND

J1-9 RA

J1-10 LA

J1-11 LL

J1-12 V1

J1-13 Not connected


J1-14 RL

Preparation for use


The MAC 400 resting ECG analysis system does not require installation.
However, you may want to customize the system settings. Once the
operating parameters are set, the system saves the settings as the
default parameters and activates them each time the system is turned
on.

The Setup menu overview


Use the setup menu to navigate between system settings and select the
options you want.

1. Press the configuration key to access the setup menu. The


first menu item is Language.

2. Use the up/down cursor to select a menu item.

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

4. Press enter to confirm your selection.

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5. Press the configuration key to save settings and exit the


setup menu.

Setting options
Operating parameters can be customized using the setup menu. To
change or set options, follow the steps for each menu item. Following are
several of the most common settings. For more information about setting
operating parameters, see the “MAC 400 Resting ECG Analysis System
Operator’s Guide”.

To access the options menu and initiate any of the following setting

selections, press the configuration key.

Selecting a language
You can select the language for the display text and printed ECG reports.

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

2. Use the right/left cursor to choose your preferred language.

3. Press enter to confirm your selection.

NOTE
When you choose Chinese or Russian, changes only affect printed
reports. The display remains in English.

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.

3. Press enter to confirm your selection.

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Setting the date and time for printed ECG reports


To set the date:

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

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.

Selecting heart rate limit values

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

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 the right/left cursor to change the high limit value


(between 80 and 240 BPM).

5. Press enter to confirm your selection.

NOTE

After setting these options, you must press configuration


to save the options and exit the setup menu.

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Printing settings
It is recommended that you print the current settings of the system
before performing any maintenance.

1. Press configuration to enter the setup menu.

2. Use the up/down cursor to navigate to Print.

3. Select Yes and press enter to confirm your selection and print
the settings.

Restoring options
When the main PCB assembly is replaced, you need to restore the
original options.

Restoring the serial number


When the main PCB is replaced, the serial number needs to be restored.

1. Turn off the power.

2. Press and hold the enter and copy keys together and
turn on the device. Keep the key combination depressed until Enter
serial number displays.

3. Use the left/right cursor keys to enter the alphanumeric

serial number and select the characters with the start/stop


key. After you enter the entire 13 digits, the display briefly goes
blank and then displays Ser. No. Stored.

Restoring the interpretation option


When the main PCB is replaced, use the option activation code to restore
the original option. The option code label is located on the side of the
device near the patient cable connector.

1. Turn off the power.

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2. Press and hold the lead selection key and left cursor
together and turn on the device. Keep the key combination depressed
until Option code displays.

3. Use the left/right cursor keys to enter the 12-digit numeric


option code. After you enter the entire code, the display briefly goes
blank and then displays Option Enabled.
To confirm that you have restored options, print the configuration list as
described in “Printing settings” on page 2-22.

Diagnostic tests
All messages displayed during self tests are in English. The system
menu guides you through the functions and testing.

Self test
When the MAC 400 system is initially turned on, Self-Test…Please wait
displays. Self-test displays in English. Self-test includes the following
tests:

„ ROM test
„ RAM test
„ DSP test
If any of these tests fail, the corresponding error code displays the
message: Test failed...4 ROM (2 RAM, 5 DSP) error.

Device tests
The device test function tests various modules of the system and are
conducted through the keyboard interface. To initiate diagnostic device
tests, press and hold the right cursor and configuration key together
until Device test displays. Press the right/left cursor keys to display the
previous/next test.
1. Key test (with beep test)
2. Display test
3. Motor test
4. Recording test

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5. Results test

Key test
Device test KEY TEST displays. Press the enter key to initiate the key
test. During the test mode, when each key is pressed the corresponding
name of that key displays. The names are identified in “Table 2-13: Key
names” on page 2-24.

Table 2-13: Key names

Key Display message

Enter KEY_ENTER

Up cursor CUR_UP

Down cursor CUR_DOWN

Right cursor CUR_RIGHT

Left cursor CUR_LEFT

Lead selection KEY_LEAD

Copy KEY_COPY

QRS Beep KEY_BEEP (accompanied by a beep sound)

Config KEY_CONFIG

Start/Stop Exits key test and displays Device test and moves to next
test

Display test
Device test DISPLAY TEST displays. To test the display:

1. Press the enter key to start the display test.


2. Press the right cursor key. Two rows of 16 black squares display.
3. Press the left cursor key to clear the display.
4. Press the enter key to exit and move to the next test.

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Motor test
Device test MOTOR TEST displays. To test the speed of the motor:

1. Press enter to start the motor test.


2. Use the up/down cursor keys to select the speed: 5, 25, or 50 mm/s.
3. Press the start/stop key to begin printing short lines on the edges of
the paper. The distance between consecutive short lines indicates the
selected speed.
4. Press the start/stop key to stop the printing and then press the
enter key to move to the next test.

Recording test
Device test RECORDING TEST displays. To test the recording:

1. Press the enter key to start the recording test.


2. Use the up/down and right/left cursor keys to select the speed 5,
25, or 50 mm/s and the gain 5, 10, or 20mm/mV.
3. Press the enter key to print the two channel wave form.
4. Press the start/stop key to stop printing and then press the enter
key to move to the next test.

Results test
Device test RESULTS displays. Press the start/stop key to print one
page results. The printed output supplies data on the software contained
in the unit (reference number, version number, date of preparation of the
firmware), the results of the tests carried out during power-up, and
details on the connected patient lead.

To exit the device diagnostic tests, press the config key and the left
cursor together.

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3 Maintenance

2036039-001A MAC™ 400 3-1


Maintenance

Recommended maintenance
A regular equipment maintenance program helps prevent unnecessary
equipment and power failures and reduces possible health hazards. This
chapter contains instructions for the following recommended
maintenance:

„ Inspecting and cleaning the device.


„ Electrical safety
‹ Ground continuity test to verify all exposed metal is properly
grounded.
‹ Leakage tests to verify the equipment does not propose any
health hazard.

WARNING
PROPER MAINTENANCE REQUIRED — Failure to
implement the recommended maintenance schedule may
cause equipment failure and possible health hazards.

All responsible individuals employing the use of this


device assume the responsibility for performing the
recommended maintenance unless an Equipment
Maintenance Agreement exists.

Required tools and supplies


In addition to a standard set of hand tools, you need the following items:

„ Multimeter
„ Leakage current tester
„ Anti-static wrist strap

Inspections and cleaning


„ Check the device and accessories for mechanical defects, which can
impair their functioning.
„ Perform a functional check as detailed in “Device tests” on page 2-23.
„ Ensure that the labels and inscriptions on the device relating to
safety are clearly legible.

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Maintenance

Visual inspection
„ Ensure that the fuses comply with the vendor’s specifications.
„ Inspect cords and cables for fraying or other damage.
„ Check the case and display for cracks or other damage.
„ Inspect the keys and keyboard for labeling integrity and operation.

Exterior cleaning
Clean the exterior surfaces once per month, and more frequently if
needed.

„ Use a clean, soft cloth and water with a mild detergent. Wring excess
water from the cloth and wipe down the exterior surfaces of the
device.
„ Dry the surfaces with a clean cloth or paper towel.

Interior cleaning
Check for dust on the interior components and clean as needed with
commercially available compressed air.

Clean the thermal printhead periodically to ensure good print quality


and long printer life. To clean the thermal printhead:

1. Use a disposable wrist strap to avoid static electricity.


2. Open the printer door and separate the platen from the printhead.
3. Wipe the glazed surface of the thermal printhead gently with cotton
swabs and ethyl alcohol.
4. When the surfaces are dry, fix the platen in place and close the
printer door.
NOTE
Do not hit the thermal printhead with anything hard.
Do not use sand paper on the thermal printhead.

Do not add any unnecessary force on the thermal printhead.

Electrical safety tests


The suggested safety analysis tests comply to the international standard
IEC 60601-1. The tests should be performed with safety testing

2036039-001A MAC™ 400 3-3


Maintenance

instruments with measuring circuits calibrated according to IEC 60601-


1. To ensure personal safety, refer to the testing instrument’s user
documentation.

Perform the tests under normal ambient conditions of temperature,


humidity and pressure, with line voltage.

The leakage currents correspond to 110% of rated voltage for the tested
unit. If this is not taken into account when performing leakage tests, the
measured values must be calculated.
When performing the electrical tests, you can connect the ground probe
of the safety tester to the printer mounting base (A) or the aluminum
insulation plate (B) as indicated in the following graphic.

071

Recommended test equipment


„ Safety tester for measurements according to 60601-1.
„ Testing connector as described for the individual tests.

GE recommended test schedule


„ After initial setup.
„ Once every 12 months thereafter as part of a regular maintenance
plan.

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Maintenance

„ Whenever power sources are affected by servicing.

Ground resistance test


This test determines whether the device has a power ground fault per
IEC 60601-1 (Ed. 2.1), section 3, clause 18.

„ This test measures the ground resistance from the device power inlet
ground terminal to any exposed conductive part of the device.
„ Test circuit specifications: AC current source 50 Hz/60 Hz of 25A or
1.5 times the rated current (whichever is greater) with a limited no-
load output of 6V.
„ Per IEC 60601-1, test the device’s power inlet ground terminal. Any
resistance greater than 100 mOhm results in failure.

Leakage current tests


The following electrical diagram shows the Measuring Circuit [M]
required for leakage current. The reading in mV corresponds to mA
(leakage current). The safety tester instruments generally work with this
Measuring Circuit [M] and the displayed values are converted to leakage
current.

033

2036039-001A MAC™ 400 3-5


Maintenance

Earth leakage (AC line) current test

078
This test measures leakage current of the device’s internal power supply.
The device has to be turned on and off, and connected to your safety-
testing equipment.

Measurements should be taken under the following conditions (refer to


the safety tester diagram):

„ Device in “ON” state


„ Polarity switch NORM and RVS
„ S1 (neutral) closed and open
„ GND switch open
The test has failed if the measured values are greater than:

Polarity: NORM & RVS Polarity: NORM & RVS

S1 (neutral): closed S1 (neutral): open

GND: open GND: open

Total tests/combinations: 2 Total tests/combinations: 2

500 uA (IEC) 1,000 uA (IEC & UL)

300 uA (UL)

3-6 MAC™ 400 2036039-001A


Maintenance

Enclosure (Chassis) leakage current test

034
This test measures leakage current from the chassis to ground during
normal condition (N.C.) and single fault conditions (S.F.C.). In all cases,
the leakage current is measured from any exposed conductive parts to
ground; the device has to be turned on and off, and connected to your
safety-testing instrument.
During N.C., measurements should be taken under the following
conditions (refer to the safety tester diagram):

„ Device in “ON” state


„ Polarity switch NORM and RVS
„ GND switch GND closed
„ S1 (neutral) closed
During S.F.C., measurements should be taken under the following
conditions (refer to the following safety tester diagram):

„ Device in “ON” state


„ Polarity switch NORM and RVS
„ GND switch closed, S1 (neutral) open
„ GND switch open, S1 (neutral) closed
The test has failed if the measured values are greater than:

2036039-001A MAC™ 400 3-7


Maintenance

N.C. S.F.C.

Polarity: NORM & RVS Polarity: NORM & RVS

S1 (neutral): closed S1 (neutral): closed I open

GND: closed GND: open I closed

Total tests/combinations: 2 Total tests/combinations: 2

100 uA (IEC & UL) 500 uA (IEC)

300 uA (UL)

Patient leakage current tests


These tests measure leakage current of the device’s floating inputs
(patient connections) to ground.

Patient leakage current to ground

077
This test measures leakage current from the floating input (patient
connection) to ground during normal condition (N.C.) and single fault
condition (S.F.C.). In all cases, the leakage current is measured from the
floating input to ground: The device has to be turned on and off, and
connected to your safety testing instrument.

During N.C., measurements should be taken under the following


conditions (refer to the safety tester diagram):

3-8 MAC™ 400 2036039-001A


Maintenance

„ Device in “ON” state


„ Polarity switch NORM and RVS
„ GND switch GND closed
„ S1 (neutral) closed
During S.F.C., measurements should be taken under the following
conditions (refer to the safety tester diagram):

„ Device in “ON” state


„ Polarity switch NORM and RVS
„ GND switch closed, S1 (neutral) open
„ GND switch open, S1 (neutral) closed
The test has failed if the measured values are greater than:

N.C. S.F.C.

Polarity: NORM & RVS Polarity: NORM & RVS

S1 (neutral): closed S1 (neutral): closed I open

GND: closed GND: open I closed

Total tests/combinations: 2 Total tests/combinations: 4

10 uA (IEC & UL) 50 uA (IEC & UL)

Patient leakage current, Mains on applied part

035

2036039-001A MAC™ 400 3-9


Maintenance

WARNING
PERSONAL SAFETY — MAINS VOLTAGE is applied
to floating input (patient connection) and patient cables/
test plug conductors and safety tester PATIN JACK.

For the protection of the person performing these tests,


the following values of resistor R may be used:

„ Type CF — 100 kOhm (220 to 240 V)


Disconnect safety tester from line voltage before
connecting patient cable/test plug to device.

„ After line voltage has been disconnected, connect the


patient cable/test plug to device.

This test performs leakage current tests during single fault conditions
(S.F.C.) with line voltage applied to the floating (patient connection)
inputs.

In all cases, the leakage current is measured from the floating (patient)
inputs jack of the device to ground. To setup this leakage current test:

1. Disconnect the safety tester from the line voltage


2. Ground all signal input/output connections (all SIPs/SOPs connected
to ground)
3. Connect the patient cable/test plug to device
4. Connect the patient cable/test plug to the safety tester
5. Ensure that the person/tester in not touching the patient cable/test
plug or floating (patient) input or device conductive surfaces
6. Connect safety tester to line voltage —see warning on previous page.
During S.F.C, measurements should be taken under the following
conditions (refer to safety tester diagram):

„ Device in “ON” state


„ Polarity switch NORM and RVS
„ S1 (neutral) open
„ GND switch closed
The test has failed if the measured values are greater than:

3-10 MAC™ 400 2036039-001A


Maintenance

N.C. S.F.C.

N/A Polarity: NORM & RVS

S1 (neutral): open

GND: closed

Total tests/combinations: 0 Total tests/combinations: 2

N/A 50 uA (IEC & UL)

After completing this test, disconnect the safety tester from line voltage
before disconnecting the patient cable/test plug and/or the device.

Replacing components
When it is determined that a component is faulty, refer to the following
instructions for replacement. Follow the safety instructions when
replacing components.

WARNING
OPERATOR SAFETY — Repairing device when powered
on may cause injury.

Turn off the device before replacing components.

Safety instructions
When repairing the MAC 400 device, the following considerations apply:

„ Only approved personnel may conduct repairs.


„ Before opening the device, turn off the power and disconnect the
mains plug from the power inlet module. Never connect the mains
plug when the device is open.
„ Before opening the device or completing any servicing, remove the
battery.
„ Before replacing the primary fuses in the power inlet module, turn
off the power and disconnect the mains plug.
„ Only the original GE Healthcare components identified in the FRU
list may be used.
„ When replacing electronic components, implement ESD protection.

2036039-001A MAC™ 400 3-11


Maintenance

„ Defective or empty LI-Ion batteries should be disposed of in


accordance with the applicable legal stipulations or returned to the
factory.

Replacing the battery

036
1. Remove the screw fastening the battery cover to the bottom cover.

2. Slide and raise the battery cover and remove the battery from its
compartment.

3. Place the new battery in to the battery compartment with the battery
label facing downwards, and the battery terminals facing the battery
contacts on the PCB. Reverse voltage protection is implemented
mechanically.

3-12 MAC™ 400 2036039-001A


Maintenance

Replacing the primary fuses in the power inlet module

037
1. Depress the latch and slide the fuse holder from the power inlet
module.

2. Remove the two fuses from the fuse holder.

3. Insert the two new fuses.

4. Secure the fuse holder back into its position.

CAUTION
EQUIPMENT PERFORMANCE — Use of unapproved
components may interfere with device performance.

Only use fuses indicated on the product label.

Opening the device

2036039-001A MAC™ 400 3-13


Maintenance

038
1. Remove the battery as described in“Replacing the battery” on page 3-
12.

2. Turn the device upside down and remove the four fastening screws
on the bottom.

3. With the keyboard facing up, open the printer door along with the
platen.

4. Raise the top cover of the housing and disconnect the keyboard cable
from the J9 connector.

The display remains fixed on the PCB.

NOTE
If you need to replace the top cover assembly, dispose of the faulty
(old) one and reassemble with the new top cover assembly.

Replacing the thermal printer

3-14 MAC™ 400 2036039-001A


Maintenance

039
1. Open the device and printer door as described in “Opening the
device” on page 3-13.

2. Open connector J7 to disconnect the flat ribbon printer cable.

3. Remove the platen from the printer door.

4. Remove the two screws fastening the base of the printer to the
printer bracket.

5. Align the mounting holes of the new printer with those on the printer
bracket.

6. Use the screws to fasten the printer onto the printer enclosure.

7. Connect the flat ribbon cable to the printer connector on the PCB.

8. Align the platen on the printer door and press it into position.
NOTE
Ensure that the platen gear aligns with the gears of the thermal
printer.

2036039-001A MAC™ 400 3-15


Maintenance

Replacing the display

040

1. Open the device as described in “Opening the device” on page 3-13.

2. Disconnect the display cable connector from the J8 connector on the


main PCB.

3. Remove the four screws fastening the display to the display


mounting bracket.

4. Align the new display mounting holes to those on the display


mounting bracket and fasten the display with the screws.
5. Connect the display cable connector to the J8 connector on the main
PCB.

Replacing the PCB assembly

3-16 MAC™ 400 2036039-001A


Maintenance

041
NOTE
If possible, print out the current settings before replacing the PCB
assembly. For information about the configuration settings, see
“Printing settings” on page 2-22.

1. Open the device as described in “Opening the device” on page 3-13.

2. Disconnect the power supply connector from J10.

3. Disconnect the display cable from J8.

4. Remove the two screws fastening the display bracket assembly and
remove it.

5. Disconnect the printer cable from J7.

6. Remove the four screws fastening the PCB assembly to the


aluminum plate.

NOTE
Return the PCB assembly to the factory in ESD packaging.

2036039-001A MAC™ 400 3-17


Maintenance

7. Orient the new main PCB assembly, align the mounting holes with
those in the aluminum plate, and fasten the new PCB assembly to
the plate with the screws.

8. Re-fasten the display and display bracket to the PCB and plate with
the screws.

9. Re-connect the printer cable to J7, the power supply cable to J10, the
keyboard cable to J9 and the display cable to J8.

10. Re-attach the upper section of the device to the lower section with the
four screws.

11. Replace the battery in the battery pocket, slide on the cover and re-
fasten with the screw.

12. Turn on the device and enter the settings as described in “Setting
options” on page 2-20.

13. Enter the serial number and option code (optional) as described in
“Restoring options” on page 2-22.
14. Adjust the display contrast as described in “Adjustment instructions”
on page 3-24.

15. Adjust the time and date.

16. If possible, set the configuration to the previous user settings. If not,
select the default settings.

Replacing the RTC battery

3-18 MAC™ 400 2036039-001A


Maintenance

042

1. Remove the PCB assembly as instructed in steps 1-6 of “Replacing


the PCB assembly” on page 3-16.

2. With the display connector at the top and facing upwards, locate the
RTC battery BT1 on the left side of the PCB.

3. Turn the PCB assembly over and de-solder the battery contacts to
remove the battery.

NOTE
Dispose of battery according to local municipal waste guidelines.

4. Remove the two solder patches.

5. Solder the new battery into position on the PCB.

6. Replace the two solder patches.

7. Turn on the device and when you see the main menu, press the
configuration key.

8. Adjust the time and date.

Replacing the OTPROM

2036039-001A MAC™ 400 3-19


Maintenance

075

1. Remove the PCB assembly as instructed in steps 1-6 of “Replacing


the PCB assembly” on page 3-16.

2. With the display connector at the top and facing upwards, locate the
OTPROM in the upper center of the PCB.

3. Remove the OTPROM from the board.

4. Insert the new OTPROM and fit it into position.

Replacing the 12V power supply

3-20 MAC™ 400 2036039-001A


Maintenance

0432

1. Remove the main PCB as instructed in steps 1-6 of “Replacing the


PCB assembly” on page 3-16.

2. Remove the five screws fastening the aluminum plate to the bottom
cover.

3. Remove the two screws on the power inlet module bracket.

4. Remove the screw fastening the ground wire to the printer bracket.

5. Turn over the aluminum plate and disconnect the yellow/green wire
from the yellow/green wire of the toroid.
6. Disconnect the white and black wires from the power inlet module.

7. Remove the four screws to unfasten the power supply from the
mounting plate.

2036039-001A MAC™ 400 3-21


Maintenance

8. Align the new power supply mounting holes to the power supply
mounting plate and replace the four screws.

9. Connect the yellow/green wire of the power supply to the yellow/


green wire of the toroid.

10. Connect the black wire of the power supply to the terminal marked
‘N’ of the power inlet module, and connect the white wire to the
terminal marked ‘L’.
11. Complete steps 11-15 of“Replacing the power inlet module along with
the toroid assembly” on page 3-22.

Replacing the power inlet module along with the toroid assembly

3-22 MAC™ 400 2036039-001A


Maintenance

044

1. Remove the main PCB assembly as instructed in steps 1-6 of


“Replacing the PCB assembly” on page 3-16.

2. Remove the power supply shield as described in steps 1-6 of


“Replacing the 12V power supply” on page 3-20.

3. Disconnect the yellow/green connector from the power inlet module.

4. To remove the power inlet from the mounting bracket, depress the
locking tabs on the top and bottom and slide the inlet out.
5. Insert the new power inlet into the bracket and snap into place.

6. Replace the toroid:

a. Pry the adhesive-backed holder from the shield.

2036039-001A MAC™ 400 3-23


Maintenance

b. Place the new toroid into position on the shield, remove the
plastic from the adhesive-backed holder and place as shown in
drawing.

NOTE
Ensure that the toroid is centered between the mounting
holes.

7. Connect the yellow/green wire of the toroid to the yellow/green wire


of the power supply.
8. Connect the yellow/green wire terminal to the power inlet terminal
marked

9. Connect the white wire to the terminal marked “L” and the black
wire to the terminal marked “N” of the power supply to the power
inlet module.

NOTE
Use care to ensure that the power inlet connections are properly
assembled as indicated in drawing.

10. Connect the earthing cable of the toroid supply to the thermal printer
base mounting hole.

11. Replace the shield and power supply assembly by turning it over and
aligning the screw holes.

NOTE
Before tightening the shield screws, confirm that the power
supply cable and grounding cable are properly positioned.

12. Replace the screws fastening the power inlet bracket to the lower
housing.

13. Replace the screw holding the ground cable to the printer bracket.

14. Replace the screws on the shield.


15. Replace the main PCB assembly as described in “Replacing the PCB
assembly” on page 3-16.

Adjustment instructions
No adjustment of components is required for the MAC 400 device.

When the PCB assembly or display is exchanged, the contrast of the


display must be adjusted to optimum contrast. To adjust the contrast:

3-24 MAC™ 400 2036039-001A


Maintenance

1. Press the configuration key.

2. Press the up/down cursor until contrast displays.

3. Use the left/right cursor to adjust the contrast.

4. When you set the desired contrast level, press the configuration
key to exit the setup menu.

2036039-001A MAC™ 400 3-25


Maintenance

3-26 MAC™ 400 2036039-001A


4 Troubleshooting

2036039-001A MAC™ 400 4-1


Troubleshooting

This section contains troubleshooting instructions for specific problems.


When a particular problem is observed, the service personnel should
follow the sequence described to pinpoint the area of failure.

Only approved personnel may conduct repairs. For safety information,


refer to “Safety instructions” on page 3-11.

Device connected to mains but does not turn on


There are two scenarios that might exist when the device does not power
on. Refer to the information for the one that you have observed, and
follow the steps outlined in the flow chart to pinpoint the faulty
component.

Green LED does not light up and device does not turn on
When valid mains is connected to the MAC 400 device, the green LED on
the keyboard lights up. When the device is connected to mains and it
does not turn on, follow the steps in the following flowchart to pinpoint
the defective component. To replace components, see “Opening the
device” on page 3-13.

4-2 MAC™ 400 2036039-001A


Troubleshooting

045

Green LED lights up and device does not turn on


When the device is connected to valid mains, the green LED on the
keyboard lights up. If the device is connected to mains, and the green
LED lights up but the unit does not turn on, follow the steps in the
following flowchart to pinpoint the defective component. Refer
to“Opening the device” on page 3-13 when replacement is required.

2036039-001A MAC™ 400 4-3


Troubleshooting

046

Battery only connection and device does not turn on


The MAC 400 system only prints/records ECGs when a battery is
installed. If the device does not turn on, use the following flowchart to
diagnose the problem.

4-4 MAC™ 400 2036039-001A


Troubleshooting

047

2036039-001A MAC™ 400 4-5


Troubleshooting

Blank display
If the device is on and the audible tone (beep) sounds but the display is
blank, follow the steps in the following flowchart to pinpoint the faulty
component.

048

Errors detected during self test


If any errors are detected during self-test, the error message Test
failed… in addition to the error code and brief description display.

4-6 MAC™ 400 2036039-001A


Troubleshooting

Errors detected during printing


There are several errors that can occur when the device is printing. Refer
to the error on the display and use the troubleshooting flowcharts to
determine the reason for the error.

Battery error
The MAC 400 device can only print when it is powered by the battery.
When Battery Error displays, follow the steps identified in the following
flowchart.

2036039-001A MAC™ 400 4-7


Troubleshooting

049

4-8 MAC™ 400 2036039-001A


Troubleshooting

Printer door open


The thermal printer has a micro-switch which detects when the printer
door is closed. When Door Open displays, follow the steps outlined in the
following flowchart.

050

Paper problem
When a problem occurs with the thermal paper, Paper Problem displays.
Follow the steps outlined in the following flowchart to diagnose the
problem.

2036039-001A MAC™ 400 4-9


Troubleshooting

051

Paper is moving but not printing


If the paper is progressing but no data is printed on it, follow the steps
outlined in the following flowchart to diagnose the problem.

4-10 MAC™ 400 2036039-001A


Troubleshooting

052

Data does not print on the upper or lower edges of paper


Follow the steps outlined in the following flowchart to determine why the
printing is incomplete.

2036039-001A MAC™ 400 4-11


Troubleshooting

053

Printing only baselines


Follow the steps outlined in the following flowchart to diagnose the
baseline only problem.

4-12 MAC™ 400 2036039-001A


Troubleshooting

054

2036039-001A MAC™ 400 4-13


Troubleshooting

4-14 MAC™ 400 2036039-001A


5 Parts List and
Replacement

2036039-001A MAC™ 400 5-1


Parts List and Replacement

Ordering parts
General information
This chapter identifies the FRU parts and FRU kits with part numbers
and images. You can order parts for the assemblies, stand-alone FRUs,
and FRU kits that are considered field-serviceable. Only items,
assemblies, and kits which have part numbers provided in this chapter
are available as FRUs. To order parts, contact GE Service or a GE
approved vendor.

Accessory kits

Table 5-1: Accessory kits

Part Number Description

2035819-001 IEC starter kit (includes one ECG cable with lead wires,
four clamp electrodes, six bulb electrodes, one pack of z-
fold paper & gel).

2035819-002 AHA starter kit (includes one ECG cable with lead wires,
four clamp electrodes, six bulb electrodes, one pack of z-
fold paper & gel).

Service manual

Table 5-2: Service manual

Part number Description Language

2036039-001 Paper/printed version of the MAC 400 service English


manual

2036039-002 Electronic PDF version of the MAC 400 service English


manual and the 12SL Physician’s Guide

5-2 MAC™ 400 2036039-001A


Parts List and Replacement

Operator’s guides

Table 5-3 Operator’s guides

Part Number Description Language

2032589-001 MAC 400 operator’s guide English (ENG)

2032589-002 MAC 400 operator’s guide German (GER)

2032589-003 MAC 400 operator’s guide French (FRE)

2032589-004 MAC 400 operator’s guide Dutch (DUT)

2032589-005 MAC 400 operator’s guide Italian (ITA)


2032589-006 MAC 400 operator’s guide Spanish (SPA)

2032589-007 MAC 400 operator’s guide Portuguese B (POR)

2032589-008 MAC 400 operator’s guide Russian (RUS)


2032589-009 MAC 400 operator’s guide Hungarian (HUN)

2032589-010 MAC 400 operator’s guide Polish (POL)

2032589-011 MAC 400 operator’s guide Czech (CZE)


2032589-012 MAC 400 operator’s guide Chinese (CHS)

2032589-013 MAC 400 operator’s guide Slovakian (SLO)

2032589-014 MAC 400 operator’s guide Greek (GRE)


2032589-015 MAC 400 operator’s guide Korean (KOR)

2032589-016 MAC 400 operator’s guide Bulgarian (BUL)

2032589-017 MAC 400 operator’s guide Turkish (TUR)


2032589-018 MAC 400 operator’s guide Lithuanian (LIT)

2032589-019 MAC 400 operator’s guide Latvian (LAT)

2032589-020 MAC 400 operator’s guide Estonian (EST)

Power cords

2036039-001A MAC™ 400 5-3


Parts List and Replacement

Table 5-4: Power cords

Part Number Description Country

405535-006 Power supply cord RA Hospital Grade 13A North America/Central America/Japan
125 V 10 FT

401855-018 Power Cord ST CHINA RA PLUG 10A 250V China


2.5M

401855-101 Power Supply Cord ST CONT EURO 10A Europe


250V 2.5M
401855-102 Power Supply Cord ST BRITISH 10A 250V Britain
2.5M FSD

401855-103 Power Supply Cord ST ITALIAN 10A 250V Italy


2.5M

401855-104 Power Supply Cord ST ISRAELI 10A 250V Israel


2.5M

401855-107 Power Supply Cord ST SWISS 10A 250V Switzerland


2.5M

2035953-001 Power Supply Cord ST INDIAN 6A 250V 2.5M India

401855-109 Power Supply Cord ST DANISH 10A 250V Denmark


2.5M

40185-110 Power Supply Cord ST AUSTRALIAN 10A Australia


250V 2.5M

5-4 MAC™ 400 2036039-001A


Parts List and Replacement

Field replaceable units (FRUs)


Power inlet module assembly, PN 2035715-001

Item Item description

1 Power inlet module

2 Fuse holder

3 Toroid assembly

055

2036039-001A MAC™ 400 5-5


Parts List and Replacement

Lithium-ion battery, PN 2030912-001

056

5-6 MAC™ 400 2036039-001A


Parts List and Replacement

Power supply AC/DC assembly, PN 2030890-001

057

Bracket kit, PN 2034038-001

Item Item description

1 Aluminum shield plate

2 Power supply mounting plate

3 Power in module holder

4 Printer mounting base


5 Display mounting bracket (small LCD)

6 Patient cable connector holder

7 Insulation board - shield plate AL

2036039-001A MAC™ 400 5-7


Parts List and Replacement

058

5-8 MAC™ 400 2036039-001A


Parts List and Replacement

Main PCB assembly, PN 2031342-001

059

Software OTPROM, PN 2034041-001

Item Item description

1 OTPROM
2 CODE MAC 400

060

2036039-001A MAC™ 400 5-9


Parts List and Replacement

LCD assembly with cable and connector, PN 2030892-001

061

Printer module complete, PN 2030893-001

062

5-10 MAC™ 400 2036039-001A


Parts List and Replacement

Printer door assembly, PN 2031344-001

Item Item description

1 Printer door part

2 Printer door hinge component (2)

063

2036039-001A MAC™ 400 5-11


Parts List and Replacement

Top cover assembly with keyboard, PN 2031345-001

064

Bottom cover kit, PN 2034039-001

Item Item description

1 Bottom cover
2 Rubber foot - SJ5012, 12.7mm DIA, 3.5mm thick (4)

3 Battery cover

4 Paper lifting tape

5-12 MAC™ 400 2036039-001A


Parts List and Replacement

065

Hardware kit, PN 2034040-001

Item Item description

1 SCR-DIN 7985-M3x10-4.8-Z-A2F (ISO7045) (24)

2 SCR-FH# 4-40 X 1/4” ZINC AHNL DIN 965 (2)


3 SCR-DIN 7985-M3x12-4.8-Z-A2F (ISO7045) (6)

4 SCR-DIN 7985-M2x6-4.8-Z-A2f (ISO7045) (6)

2036039-001A MAC™ 400 5-13


Parts List and Replacement

066

Fuse kit, PN 2034042-001


Fuse 2.0A SLO-BLO 250V 5x20mm (2)

067

5-14 MAC™ 400 2036039-001A


Parts List and Replacement

Clock battery, PN 2036001-001

068

Paper roll axle, PN 2030889-001

069

2036039-001A MAC™ 400 5-15


Parts List and Replacement

5-16 MAC™ 400 2036039-001A


A Technical Specifications

2036039-001A MAC™ 400 A-1


Technical Specifications

Instrument type High cut-off frequency 150 Hz (-3-dB limits), 35 Hz or


20 Hz if muscle filter is enabled

Microprocessor augmented automatic electrocardiograph: 10- Common mode rejection > 100 dB @ 50/60 Hz (AC filter
leadwire acquisition with programmable lead configuration. switched on)

Processing Input impedance > 10M Ω @ 10 Hz,


defibrillator protected

Acquisition and analysis 12 leads—simultaneous Patient leakage


< 10 μA

Signal input Type CF according to IEC. Operating modes Automatic mode (12 lead data),
However, not intended for direct Manual (real-time data),
cardiac application. Arrhythmia (continuous
monitoring)
Digital sampling >1000 samples/second/channel Lead printout sequence Standard (Einthoven), Cabrera

ECG analysis frequency 500 samples/second/channel Report formats Automatic: simultaneous (short
and long format), sequential
(with or without rhythm);
Manual: 1 or 3 channel real
time printout; Arrhythmia:
continuous monitoring with
event documentation

Dynamic range AC differential +/-5 mV, DC Heart rate meter 30 to 300 BPM ±2% or ±1
offset (Polarization voltage) +/- BPM, whichever is greater.
300 mV Heart rates outside this range
do not display.

Resolution
5 μV Baseline adjustment Automatic adjustment of the
baseline to the optimal
recording range.

Frequency response 0.01 to 150 Hz Anti-drift system (ADS) Automatic compensation of


baseline

Low cut-off frequency 0.01 Hz, 0.04 Hz, 0.08 Hz or Lead-fail indication Audible and visual indication of
0.16 Hz (-3-dB limits), equivalent disconnected electrodes or line
to a time constant of 16s, 4s, 2s, break; each single electrode is
or 1s monitored except N/right leg

A-2 MAC™ 400 2036039-001A


Technical Specifications

Software options Marquette 12SL ECG-based Paper size Width 80 mm


measurement package gives QRS,
QT/QTC, PR, P, RR/PP, and P/QRS/T Z-fold length 90 mm, 280 sheets/
pack
Marquette 12SL ECG-based analysis
package for analysis and interpretation Roll paper length 15.7 m

Display Writer speeds accuracy Typical +/- 1


Maximum +/- 5%

Type LCD, 2 row x 16 character Writer amplitude +/- 5%


alphanumeric with adjustable contrast accuracy

Displayed data Selected lead group, operation mode, Keyboard


lead check, heart rate, AC filter,
muscle filter, gain (sensitivity), speed

Writer Type Membrane keyboard with tactile


feedback

Writer technology Thermal array printhead Power supply

Resolution Vertical 8 dots/mm Ratings 100 to 240 V +/- 10%

Horizontally 40 dots/mm at 25 mm/s


Number of traces 3 in automatic and arrhythmia modes Frequency 50/60 Hz +/-10%

1 or 3 in manual mode

Annotations of device settings, date


and time in the margin of recording
strip
Writer speeds 5, 25, 50 mm/s Battery type Lithium ion, 7.2 V

5mm/s is not available in auto mode

Writer sensitivity 5, 10, 20 mm/mV Battery charge time Approximately 3 hours


(gain)

Paper type Z-fold, roll Battery charging Automatic battery charging via
built-in charger during line-power
operation

2036039-001A MAC™ 400 A-3


Technical Specifications

Battery capacity 100 “automatic” ECG recordings Relative humidity


or operating time recording of 4
hours without recording

Physical specifications Transport/storage 25-95%


Width 263 mm Operating 25-95%

Height 78 mm Pressure

Depth 208 mm Transport/storage 500 to 1060 hPa

Weight 1.3 kg/2.86 lb. with battery Operating 700 to 1060 hPa

Environmental specifications

Temperature (with battery)

Transport/storage -15° C to + 50° C Certification

Operating +10° C to 40° C a) Complies to UL 60601-1 and CAN/CSA C22.2 No. 601.1

c) CB certified for IEC 60601-1, IEC 60601-2-25, IEC 60601-2-51

d) CE marking for Council l DIrective 93/42/EEC concerning


medical devices

e) Meets applicable AAMI EC-11 requirements

Warranty

Standard warranty is 1 (one) year.


Ordering information

Visit www.gehealthcare.com or contact your local GE representative

A-4 MAC™ 400 2036039-001A


B Electromagnetic
compatibility

2036039-001A MAC™ 400 B-1


Electromagnetic compatibility

Changes or modification to the MAC 400 system not expressly approved


by GE could cause EMC issues. This system is designed and tested to
comply with applicable regulation regarding EMC and needs to be
installed and used according to the EMC information stated as follows.

CAUTION
RADIO FREQUENCY INTERFERENCE — Use of
portable phones or other radio frequency (RF) emitting
equipment near the system may cause unexpected or
adverse operation.

Do not use RF emitting equipment near the device.

CAUTION
EQUIPMENT INTERFERENCE — If adjacent or
stacked use is necessary, the equipment or system should
be tested to verify normal operation in that configuration.

The equipment or system should not be used adjacent to,


or stacked with, other equipment.

Guidance and manufacturer’s declaration-


electromagnetic emissions

Emissions test Compliance Electromagnetic environment-guidance

RF emissions Group 1 The MAC 400 uses RF energy for its internal function.
Therefore, its RF emissions are very low and are not likely to
EN 55011 cause any interference in nearby electronic equipment.

RF emissions Class A The MAC 400 is suitable for use in all establishments other
than domestic and those directly connected to the public low-
EN 55011 voltage power supply network that supplies buildings used for
Harmonic Emissions Class A domestic purposes.

EN 61000-3-2

Voltage fluctuations/Flicker emissions Complies

EN 61000-3-3

B-2 MAC™ 400 2036039-001A


Electromagnetic compatibility

Guidance and manufacturer’s declaration-


electromagnetic immunity

Immunity test EN60601 test level Compliance level Electromagnetic environment-guidance

Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic


(ESD) tile. If floors are covered with synthetic
± 8 kV air ± 8 kV air material, the relative humidity should be at
EN 61000-4-2 least 30%.

Electrical fast Transient/ ± 2 kV for power supply ± 2 kV for power supply Mains power should be that of a typical
burst lines lines commercial or hospital environment.

EN 61000-4-4 ±1 kV for input/output lines ±1 kV for input/output


lines
Surge ± 1 kV differential mode ± 1 kV differential mode Mains power should be that of a typical
commercial or hospital environment.
EN 61000-4-5 ± 2 kV common mode ± 2 kV common mode

Voltage dips, short <5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) Mains power should be that of a typical
interruptions and voltage for 0.5 cycles for 0.5 cycles commercial or hospital environment. If the
variations on power supply user of the MAC 400 requires continued
input lines 40% Ut (60% dip in Ut) for 40% Ut (60% dip in Ut) for operation during power mains interruptions, it
5 cycles 5 cycles is recommended that the MAC 400 be
EN 61000-4-11 powered from an uninterruptable power
70% Ut (30% dip in Ut) for 70% Ut (30% dip in Ut) for
25 cycles 25 cycles supply or a battery.

<5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut)


for 5 sec for 5 sec
Power frequency(50/60 3 A/m 3 A/m Power frequency magnetic fields should be at
Hz) magnetic field levels characteristics of a typical location in a
typical commercial or hospital environment.
EN 61000-4-8

2036039-001A MAC™ 400 B-3


Electromagnetic compatibility

Immunity test EN60601 test level Compliance level Electromagnetic environment-guidance

Portable and mobile RF communications


equipment should be used no closer to any
part of the MAC 400, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms d = 1.2 P


EN 61000-4-6 150 KHz to 80 MHz
d = 1.2 P
80 MHz to 800 MHz

d = 2.3 P
800 MHz to 2.5 GHz
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).
Radiated RF 3V/m
Field strengths from fixed RF transmitters, as
EN 61000-4-3 80 MHz to 2.5 GHz 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:

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by reflection from structures, objects and
people.

B-4 MAC™ 400 2036039-001A


Electromagnetic compatibility

Immunity test EN60601 test level Compliance level Electromagnetic environment-guidance

a
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 be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distance


The following table provides the recommended separation distances (in
meters) between portable and mobile RF communication equipment and
the MAC 400 system. The MAC 400 system is intended for use in the
electromagnetic environment on which radiated RF disturbances are
controlled. The customer or the user of the MAC 400 system can help
prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the MAC 400 system as recommended below,
according to the maximum output power of the communications
equipment.

Separation distance in meters (m) according to frequency of transmitter


Rated maximum 150KHz to 80MHz 150KHz to 80MHz
output power of 80MHz to 800MHz 800MHz to 2.5GHz
outside ISM bands outside ISM bands
transmitter in watts
d = 1.2 P d = 2.3 P
d = 1.2 P d = 1.2 P
0.01 0.12 0.12 0.12 0.23

0.1 0.38 0.38 0.38 0.73

1 1.2 1.2 1.2 2.3

10 3.8 3.8 3.8 7.3

100 12 12 12 23

At 80MHz and 800MHz the separation distance of high frequency range applies.

For transmitters rated at a maximum output power not listed above, the
recommended separation distance [d] in meters (m) can be estimated

2036039-001A MAC™ 400 B-5


Electromagnetic compatibility

using the equation 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.

These guidelines may not apply in all situations. Electromagnetic


propagation is affected by absorption and reflection from structures,
objects and people.

B-6 MAC™ 400 2036039-001A


Index

Index
C 12V power supply 20
CE marking information 13 adjustment instructions 24
E battery 12
equipment identification 10 display 16
equipment service information 9 PCB assembly 16
equipment symbols 6 power inlet module with toroid display 22
F primary fuses 13
FRUs RTC battery 18
bottom cover kit 12 thermal printer 14
clock battery 15 S
complete printer module 10 setup menu 19
fuse kit 14 symbols on equipment 6
hardware kit 13 T
LCD assembly with cable and connector 10 testing
lithium-ion battery 6 display 24
main PCB assembly 9 key and audible tone 24
paper roll axle 15 self test 23
power bracket kit 7 unit functions 23
power inlet module assembly 5 troubleshooting
power supply AC/DC assembly 7 battery connection and no power 4
printer door assembly 11 battery error 7
software OTP ROM 9 blank display 6
top cover assembly with keyboard 12 connected to mains but no power 2
functionality, description 6 green LED but no power 3
M incomplete printing error 11
maintenance no green LED and no power 2
monthly inspections 2 not printing error 10
mechanical structure 5 paper problem error 9
P printer door open error 9
parts printing only baselines error 12
ordering 2 self test errors 6
PCB assembly 9 V
power supply 8 view, rear 4
R view, side 3
replacing components 11 view, top 2

2036039-001A MAC™ 400 Index-1


Index

Index-2 MAC™ 400 2036039-001A


World Headquarters European Representative Asia Headquarters
GE Medical Systems GE Medical Systems GE Medical Systems
Information Technologies, Inc. Information Technologies GmbH Information Technologies Asia; GE (China) Co., Ltd.
8200 West Tower Avenue Munzinger Straße 3-5 24th Floor, Shanghai MAXDO Center,
Milwaukee, WI 53223 USA D-79111 Freiburg 8 Xing Yi Road, Hong Qiao Development Zone
Tel: + 1 414 355 5000 Germany Shanghai 200336, P.R. China
1 800 558 5120 (US only) Tel: + 49 761 45 43 - 0 Tel: + 86 21 5257 4650
Fax: + 1 414 355 3790 Fax: + 49 761 45 43 - 233 Fax: + 86 21 5208 2008

www.gehealthcare.com

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