GE MAC 400 Service Manual_SM_2036039-001_D ROTIXA 500 RS Zentrifugen

GE Healthcare

MAC™ 400
Resting ECG Analysis System

Version - Product Code SCT

Service Manual

2036039-001 Revision D

NOTE

The information in this manual applies to MAC 400 resting ECG analysis systems with product code SCT.
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, 2008. General Electric Company. All Rights reserved.

T-2 MAC™ 400 2036039-001D

21 August 2008

Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Manual information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Revision history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Manual purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Intended audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

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

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Safety messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Responsibility of the manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Equipment symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Service information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Equipment identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Serial number format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Serial number label (non-China version) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Serial number label (China version) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Product label (non-China version) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Product label (China version) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

CE marking information (non-Chinese only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9

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

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

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

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

Description of the functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Power supply module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Main PCB assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8

Internal interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Preparation for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

The Setup menu overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16

Setting options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17

Printing settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

Restoring options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

2036039-001D MAC™ 400 i

Diagnostic tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Power on self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

Device tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Recommended maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Required tools and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Inspections and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Exterior cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Interior cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Electrical safety tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Leakage current tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Earth leakage (AC line) current test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Enclosure (chassis) leakage current test . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Patient leakage current tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Patient leakage current to ground . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

Patient leakage current, mains on applied part . . . . . . . . . . . . . . . . . . . . . . . .3-8

Replacing components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Replacing the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Replacing the primary fuses in the power inlet module . . . . . . . . . . . . . . . . . . . .3-11

Opening the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

Replacing the thermal printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

Replacing the display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14

Replacing the PCB assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15

Replacing the RTC battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16

Replacing the OTPROM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17

Replacing the 12V power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

Replacing the power inlet module along with the toroid assembly . . . . . . . . . . . .3-19

Adjustment instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20

Functional checkout procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Tools needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-21

Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22

Functional checkout procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22

Operational checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22

Diagnostic tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

Electrical safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Errors detected during self test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

ii MAC™ 400 2036039-001D

Errors detected during printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

Battery error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Printer door open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7

Paper problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Paper is moving but not printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

Data does not print on the upper or lower edges of paper . . . . . . . . . . . . . . . . . .4-10

Printing only baselines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

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

Ordering parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Accessory kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Patient Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Writer paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Service manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Operator’s guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Power cords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5

MAC 400 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5

Field replaceable units (FRUs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

B Electromagnetic compatibility (not applicable for China) . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

2036039-001D MAC™ 400 iii

iv MAC™ 400 2036039-001D

1 Introduction

2036039-001D 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 the following table.

Revision Date Comment

A 2 July 2007 Initial release of this document.

B 5 November 2007 Edited FRU part number.

C 2 January 2008 Added special content for China systems.

D 21 August 2008 Added new product label for non-China units; added Intended

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

Use and Contraindication; removed Equipment Symbols and
added a reference to the Operator's Guides; added a Functional
Checkout procedure.

Manual purpose

Intended audience

Intended use

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.

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

The MAC 400 device is intended 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 3­channel 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.

1-2 MAC™ 400 2036039-001D

Contraindications

Conventions

Introduction

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.

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

Ter m De fin ition

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.

2036039-001D MAC™ 400 1-3

Introduction

Safety messages

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

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

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.

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.

1-4 MAC™ 400 2036039-001D

Equipment symbols

See the MAC™ 400 Resting ECG Analysis System Operator’s Guides for
information about the symbols used on this product and its packaging.

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.

Equipment identification

Introduction

025

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

NOTE

The following examples are representative only. Your product label may vary.

2036039-001D MAC™ 400 1-5

Introduction

Serial number format

026

Table 1-4: Serial number description

Section Description

A Product Code for MAC 400 device

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.

Serial number label (non-China version)

027

1-6 MAC™ 400 2036039-001D

Table 1-5: Label format (non-China version)

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

Serial number label (China version)

F

Introduction

E
D

C

B
A

G

Section Description

A Date of manufacture in the format YYYY-MM

B Part number of product

C Production license

D Registration of product standards

E Product register number

F Serial number

G Barcode representation of serial number

Product label (non-China version)

079

Table 1-5: Label format (China version)

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

2036039-001D MAC™ 400 1-7

Introduction

028

Product Label (Non-China Version)

Table 1-6: Product label (Non-China Version)

Section Description

A Product name (MAC 400)

B Site of manufacture

C Rating of 12V power supply

D Dimension and rating of fuse

E

Product label (China version)

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

See the MAC

™

400 Resting ECG Analysis System Operator’s

Guides for information about the symbols used on this

label.

A

B

C

D

F E

080

Product Label (China Version)

1-8 MAC™ 400 2036039-001D

Table 1-6: Product label (China Version)

Section Description

A Product name

B Company name

C Company address

D Rated current

EFuse

FType

CE marking information (non-Chinese only)

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”.

Introduction

EMC: immunity performance

Users should be aware of known RF sources, such as radio or TV stations and hand­held 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 four instrument part numbers associated with the MAC 400 device –
two for non-Chinese systems and two for Chinese systems. The language is
determined at the configuration centers and there are no language-specific variants.

Table 1-7: Instrument part numbers (non-China systems)

Instrument Part

Number

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

operation with measurement feature (non-Chinese only)

2033547-002 MAC 400 resting ECG analysis system, 3-channel electrocardiograph for mains and battery

operation with measurement and interpretation feature (non-Chinese only)

Description

2036039-001D MAC™ 400 1-9

Introduction

Table 1-7: Instrument part numbers (China systems)

Instrument Part

Number

Description

2033547-003 MAC 400 resting ECG analysis system, 3-channel electrocardiograph for mains and battery

operation with measurement feature (China only )

2033547-004 MAC 400 resting ECG analysis system, 3-channel electrocardiograph for mains and battery

operation with measurement and interpretation feature (China only )

1-10 MAC™ 400 2036039-001D

2 Equipment Overview

2036039-001D 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

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.

029

2-2 MAC™ 400 2036039-001D

Side view

Equipment Overview

Table 2-2: Side view

Name Description

A ECG signal input connector Connect the patient cable.

030

2036039-001D MAC™ 400 2-3

Equipment Overview

Rear view

A Product label Displays product name, site of manufacture,

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 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:

031

Table 2-3: Rear view

Name Description

power supply specification, fuse specification
and relevant symbols.

 Power block

 Battery detection circuit

 Battery low indication circuit

2-4 MAC™ 400 2036039-001D

 Battery Charging Indication Circuit (Chinese systems only)

 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 available functions and operation of the MAC 400 system are described in the
operator’s guides.

Mechanical structure

Equipment Overview

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.

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 non­isolated side. The transformer transfers power from the non-isolated side to the
isolated side.

2036039-001D MAC™ 400 2-5

Equipment Overview

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.

032

2-6 MAC™ 400 2036039-001D

Power supply module

Power inlet

+12V power supply

Equipment Overview

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.

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.

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 2-7.

Table 2-4: Power supply specifications

Input voltage range 100-240V AC

Battery

Frequency 50-60Hz

Full load current 1.67A

Output voltage 12V

Line regulation 12V +/-0.5%

Load regulation 12V +/-2%

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 2-7.

Table 2-5: Battery specifications

Rated voltage 7.2V

Battery voltage 5.4-8.4V

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 3-10.

2036039-001D MAC™ 400 2-7

Equipment Overview

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%.

 A yellow LED will illuminate continuously, When battery is fully charged or

 If the voltage falls below 6.3V +/- 2%, the unit turns off automatically. (all

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

1.5A fuse for over-current protection.

(non-Chinese systems)

not charging. It will flash when battery voltage falls below 6.8V +/- 2%.
(Chinese systems only)

systems)

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 2-8 indicate the charging conditions.

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

070

2-8 MAC™ 400 2036039-001D

CPU Motorola MC68832

Memory

Real-time clock (RTC)

Equipment Overview

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

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 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,

 The beep sounds once for every QRS peak detected when the heart rate is

NOTE

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 – one green and one yellow.

 The green LED indicates that the system is connected to active mains.

 On non-Chinese systems, the yellow LED indicates that the battery voltage is

battery and paper error conditions.

within the specified limits.

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.

(all systems)

below 6.8V +/- 2%.

2036039-001D MAC™ 400 2-9

Equipment Overview

 A yellow LED will illuminate continuously when battery is fully charged

or not charging. It will flash when battery voltage falls below 6.8V +/- 2%.
(Chinese systems only)

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.

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 non­isolated 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

2-10 MAC™ 400 2036039-001D

Equipment Overview

 Serial EEPROM

 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. 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 flow 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 2-11. Input output (I/O) is with respect

to the MAC 400 system PCB.

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

2036039-001D MAC™ 400 2-11

Equipment Overview

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 2-12 for details.

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 2-12
identifies the signals involved in the interface between the display and the PCB.

Table 2-8: J11 interface signals

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

J8-3 CONTRAST CPU generates this signal as a PWM

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

used to select between data and
instruction register

J8-5 R/W* CPU generates R/W* signal. This signal

decides whether data is read from the
display or written into the display

J8-6 DISPLAY The display enable signal generated by

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

0-2V

TTL/active high

TTL/active high

3.3V/active high

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

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

2-12 MAC™ 400 2036039-001D

Table 2-9: J8 connector signals

Connector Pin Function Description Level/Polarity

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 2-13 defines the J7
connector symbols.

Equipment Overview

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

sensor

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

equal to 5V

J7-3 VHE I The output of cue mark sensor

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

input to door sensing circuit

J7-5 SW I Other terminal of door sensor

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

0-3.8V

5V

800mV-5V

TTL/active high

0V

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

2036039-001D MAC™ 400 2-13

Equipment Overview

Connector Pin Function I/O Description Level

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

J7-22 GND Ground 0V

J7-23 LAT O Latch signal TTL, active low

Table 2-10: J7 connector symbols

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 2-14.

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

2-14 MAC™ 400 2036039-001D

Equipment Overview

Table 2-11: J9 connector signals

Connector Pin Function I/O Description Level

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

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

J9-18 Battery indication

ECG lead connector

lights up when a valid mains is
connected to the device

O Non-Chinese systems:

LED

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-

16.

Connected to the yellow LED which
lights up when the battery voltage
goes below 6.8V +/- 2%

Chinese systems:
Connected to yellow LED which will
illuminate continuously when battery
is fully charged or not charging or it
will flash when battery voltage falls
below 6.8V +/- 2%.

2036039-001D MAC™ 400 2-15

Equipment Overview

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

J1-7 Cable shield

J1-8 GND

J1-9 RA

J1-10 LA

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.

J1-11 LL

J1-12 V1

J1-13 Not connected

J1-14 RL

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

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

2-16 MAC™ 400 2036039-001D

Setting options

Selecting a language

Equipment Overview

4. Press enter to confirm your selection.

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

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.

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.

Setting the date and time for printed ECG reports

To set the date:

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

2036039-001D MAC™ 400 2-17

Equipment Overview

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.

Printing settings

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.

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.

2-18 MAC™ 400 2036039-001D

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

Equipment Overview

Diagnostic tests

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.

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 2-18.

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

Power on self test

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

 ROM test

2036039-001D MAC™ 400 2-19

Equipment Overview

Device tests

 RAM test

 DSP test

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

The device test function tests various modules of the system and is conducted
through the keyboard interface. To initiate 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

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 the following table.

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

2-20 MAC™ 400 2036039-001D

Display test

Motor test

Equipment Overview

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.

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

1. Press enter to start the motor test.

2. Press 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.

Recording test

Results test

5. Press the enter key to move to the next test.

Device test RECORDING TEST displays. To test the recording:

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

2. Press 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.

5. Press the enter key to move to the next 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, and 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.

2036039-001D MAC™ 400 2-21

Equipment Overview

2-22 MAC™ 400 2036039-001D

3 Maintenance

2036039-001D 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 2-20.

 Ensure that the labels and inscriptions on the device relating to safety are clearly

legible.

Visual inspection

 Ensure that the fuses comply with the vendor’s specifications.

 Check that the patient cable and lead wires are not defective or broken.

 Check that the electrodes are not out of date.

 Inspect cords and cables for fraying or other damage.

 Check the case and display for cracks or other damage.

 Inspect the keys and keyboard to make sure they have correct markings on them

and to ensure proper operation.

3-2 MAC™ 400 2036039-001D

Exterior cleaning

Interior cleaning

Maintenance

 Confirm the Green LED is glowing when the power cord is connected to the AC

line and the AC switch is On.

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.

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.

Electrical safety tests

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.

The suggested safety analysis tests comply to the international standard IEC 60601-

1. The tests should be performed with safety testing 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.

2036039-001D MAC™ 400 3-3

Maintenance

Recommended test equipment

071

 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.

 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.

3-4 MAC™ 400 2036039-001D

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.

Earth leakage (AC line) current test

Maintenance

033

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

2036039-001D MAC™ 400 3-5

Maintenance

The test has failed if the measured values are greater than:

N.C. S.F.C.

Polarity: NORM & RVS

S1 (neutral): closed

GND: open

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

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

300 uA (UL)

Enclosure (chassis) leakage current test

Polarity: NORM & RVS

S1 (neutral): open

GND: open

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:

3-6 MAC™ 400 2036039-001D

N.C. S.F.C.

Maintenance

Polarity: NORM & RVS

S1 (neutral): closed

GND: closed

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

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

Patient leakage current tests

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

Patient leakage current to ground

Polarity: NORM & RVS

S1 (neutral): closed I open

GND: open I closed

300 uA (UL)

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):

 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

2036039-001D MAC™ 400 3-7

Maintenance

 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

S1 (neutral): closed

GND: closed

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

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

Patient leakage current, mains on applied part

Polarity: NORM & RVS

S1 (neutral): closed I open

GND: open I closed

035

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.

3-8 MAC™ 400 2036039-001D

Maintenance

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:

N/A Polarity: NORM & RVS

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.

N.C. S.F.C.

S1 (neutral): open

GND: closed

Turn off the device before replacing components.

2036039-001D MAC™ 400 3-9

Maintenance

Safety instructions

Replacing the battery

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.

 Defective or empty LI-Ion batteries should be disposed of in accordance with

the applicable legal stipulations or returned to the factory.

036

3-10 MAC™ 400 2036039-001D

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.

Replacing the primary fuses in the power inlet module

Maintenance

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.

2036039-001D MAC™ 400 3-11

Maintenance

Opening the device

038

1. Remove the battery as described in“Replacing the battery” on page 3-10.

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.

3-12 MAC™ 400 2036039-001D

Replacing the thermal printer

Maintenance

1. Open the device and printer door as described in “Opening the device” on
page 3-12.

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.

039

2036039-001D MAC™ 400 3-13

Maintenance

Replacing the display

040

1. Open the device as described in “Opening the device” on page 3-12.

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.

3-14 MAC™ 400 2036039-001D

Replacing the PCB assembly

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-

18.

1. Open the device as described in “Opening the device” on page 3-12.

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.

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.

2036039-001D MAC™ 400 3-15

Maintenance

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 2-17.

13. Enter the serial number and option code (optional) as described in “Restoring

options” on page 2-19.

14. Adjust the display contrast as described in “Adjustment instructions” on page 3-

20.

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

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

assembly” on page 3-15.

042

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.

3-16 MAC™ 400 2036039-001D

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

8. Adjust the time and date.

Replacing the OTPROM

Maintenance

key.

075

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

assembly” on page 3-15.

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.

2036039-001D MAC™ 400 3-17

Maintenance

Replacing the 12V power supply

0432

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

assembly” on page 3-15.

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.

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 3-19.

3-18 MAC™ 400 2036039-001D

Maintenance

Replacing the power inlet module along with the toroid assembly

044

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

PCB assembly” on page 3-15.

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

12V power supply” on page 3-18.

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.

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.

2036039-001D MAC™ 400 3-19

Maintenance

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 3-15.

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:

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.

Functional checkout procedure

These checkout procedures apply to all MAC 400 systems. See “Replacing

components” on page 3-9 for FRU replacement procedures.

3-20 MAC™ 400 2036039-001D

FRU Replacement

Maintenance

FRU Description Tools Visual Inspection

Power Inlet module assembly 1 to 6 and 8 1,3,5 1, 2 1

Battery assembly 1, 3, 9 3 N/A 1, 5

Power supply module assembly 1 to 6 and 8 3 1, 2 1 and 8 to 12

Bracket kit assembly 1, 3 3 N/A 1

Main PCB assembly 1 to 6 and 8 3 1, 2 1 to 12

Software OTPROM assembly 1, 2, 3, 8 3 N/A 1, 11

LCD assembly with cable and
connector

Printer module assembly 1, 3, 8 3 N/A 1, 10

Printer door assembly 1, 3, 8 3 N/A 1, 10

Top cover assembly 1, 3, 8 3, 4, 5 N/A 1, 8, 11

Bottom cover assembly 1 to 6 and 8 3 1, 2 1 to 12

Hardware kit 1, 3 3 N/A 1

Fuse kit 3 1, 3 N/A 1

1. 2. 3 3 N/A 1, 4, 9

Electrical Safety

Test

Checkout Procedure

Clock battery assembly 1, 2, 3, 7, 8 3 N/A 1, 6

Axle for paper roll assembly 3 3 N/A N/A

Other Service Events

FRU Description Tools Visual Inspection

No parts replaced 3 3,5 N/A 1

Software update - Enable interpretation
option

Post Installation Checkout 2, 3, 4, 5, 6, 8 2, 3 1, 2 1, 11

Annual Electrical Safety tests 2, 3, 4, 5, 6, 8 3 1, 2 1, 11

3N/A N/A 3

Electrical Safety

Test

Tools needed

1. Phillips screwdriver

2. Anti-static wrist strap

Checkout Procedure

3. Service manual as needed for reference

2036039-001D MAC™ 400 3-21

Maintenance

Visual inspection

4. Safety tester for measurements according to 60601-1

5. Testing connector as described in service manual for the individual electrical
safety tests

6. Multi-meter

7. Soldering iron

8. ECG simulator

9. MAC 400 Resting ECG Analysis System Operator’s Guides for reference

Verify the following items have passed inspection.

 Fuses. See “Fuse kit, PN 2034042-001” on page 5-13.

 Cable/lead wires. See “Visual inspection” on page 3-2.

 Electodes. See “Visual inspection” on page 3-2.

 Part, cord, or cables. See “Visual inspection” on page 3-2.

 Case and display. See “Visual inspection” on page 3-2.

 Keys and keyboard. See “Visual inspection” on page 3-2.

 Green LED. See “Visual inspection” on page 3-2.

Functional checkout procedures

Perform the functional checkout procedures that are applicable to the procedure that
was performed.

Operational checks

1. Verify the power-up self-test passed. See “Power on self test” on page 2-19.

2. Verify the serial number restored successfully. See “Restoring the serial number”
on page 2-19.

3. For units with the interpretation option enabled, verify the interpretation option
restored successfully. See “Restoring the interpretation option” on page 2-19.

4. Verify the contrast adjustment was successful. See “Adjustment instructions” on
page 3-20.

5. Verify that the new battery was charged successfully. See the MAC 400 Resting
ECG Analysis System Operator’s Guides.

6. Verify the time and date were set successfully. See “Setting the date and time for

printed ECG reports” on page 2-17.

7. Verify that the last ECG was copied successfully. See the section Automatic Mode
in the MAC 400 Resting ECG Analysis System Operator’s Guides.

3-22 MAC™ 400 2036039-001D

Diagnostic tests

Electrical safety checks

Verify the current leakage test results meet the requirements. Perform electrical
safety checks when indicated. All indicated electrical safety checks require a pass/
fail indication for the steps performed. Record the measurement values in your
debrief.

Maintenance

8. Verify the keyboard test was successful. See “Key test” on page 2-20 for more
information.

9. Verify the display test was successful. See “Display test” on page 2-21 for more
information.

10. Verify the printer motor test was successful. See “Motor test” on page 2-21 for
more information.

11. Verify the recording test was successful. See “Recording test” on page 2-21 for
more information.

12. Verify the results test was successful. See “Results test” on page 2-21 for more
information.

1. Verify the equipment does not propose any health hazard. See “Earth leakage

(AC line) current test” on page 3-5,“Patient leakage current tests” on page 3-7,

and “Enclosure (chassis) leakage current test” on page 3-6 for more
information.

2. Verify all exposed metal is properly grounded. See “Ground resistance test” on
page 3-4 for more information.

Electrical Safety Checks

Step

Earth Leakage Current

1 Forward Polarity NC ______ μΑ Pass/Fail 300 μΑ

2 Neutral Open, Forward Polarity SFC ______ μΑ Pass/Fail 1,000 μΑ

3 Neutral Open, Reverse Polarity SFC ______ μΑ Pass/Fail 1,000 μΑ

4 Reverse Polarity NC ______ μΑ Pass/Fail 300 μΑ

Enclosure Leakage Current

1 Forward Polarity NC ______ μΑ Pass/Fail 100 μΑ

Condition

1

UUT - ON

2

Result Leakage Current Limits

2 Neutral Open, Forward Polarity SFC ______ μΑ Pass/Fail 300 μΑ

3 Ground Open, Forward Polarity SFC ______ μΑ Pass/Fail 300 μΑ

2036039-001D MAC™ 400 3-23

Maintenance

Electrical Safety Checks

Step

Condition

1

UUT - ON

2

Result Leakage Current Limits

4 Ground Open, Reverse Polarity SFC ______ μΑ Pass/Fail 300 μΑ

5 Neutral Open, Reverse Polarity SFC ______ μΑ Pass/Fail 300 μΑ

6 Reverse Polarity NC ______ μΑ Pass/Fail 100 μΑ

Patient Leakage Current To Ground

1 Forward Polarity NC ______ μΑ Pass/Fail 10 μΑ

2 Neutral Open, Forward Polarity SFC ______ μΑ Pass/Fail 50 μΑ

3 Ground Open, Forward Polarity SFC ______ μΑ Pass/Fail 50 μΑ

4 Ground Open, Reverse Polarity SFC ______ μΑ Pass/Fail 50 μΑ

5 Neutral Open, Reverse Polarity SFC ______ μΑ Pass/Fail 50 μΑ

6 Reverse Polarity NC ______ μΑ Pass/Fail 10 μΑ

Ground Resistance Resistance

1 AC mains power cord ground prong to

N/A ______ Ω Pass/Fail Less than 200m Ω

exposed metal surface (ground lug)

1

NC = Normal Condition; SFC = Single Fault Condition; N/A = Not Applicable

2

UUT = Unit Under Test

3-24 MAC™ 400 2036039-001D

4 Troubleshooting

2036039-001D 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 3-10.

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 3-12.

045

4-2 MAC™ 400 2036039-001D

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 3-12 when replacement is
required.

Troubleshooting

046

2036039-001D MAC™ 400 4-3

Troubleshooting

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.

047

4-4 MAC™ 400 2036039-001D

Blank display

Troubleshooting

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.

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.

2036039-001D MAC™ 400 4-5

Troubleshooting

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.

049

4-6 MAC™ 400 2036039-001D

Printer door open

Troubleshooting

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

2036039-001D MAC™ 400 4-7

Troubleshooting

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.

051

4-8 MAC™ 400 2036039-001D

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.

Troubleshooting

052

2036039-001D MAC™ 400 4-9

Troubleshooting

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.

053

4-10 MAC™ 400 2036039-001D

Printing only baselines

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

Troubleshooting

054

2036039-001D MAC™ 400 4-11

Troubleshooting

4-12 MAC™ 400 2036039-001D

5 Parts List and

Replacement

2036039-001D MAC™ 400 5-1

Parts List and Replacement

Ordering parts

General information

Accessory kits

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.

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 z­fold paper & gel).

Patient Cables

Electrodes

2035819-002 AHA starter kit (includes one ECG cable with lead wires,

four clamp electrodes, six bulb electrodes, one pack of z­fold paper & gel).

Table 5-2. Patient Cables

Part number Description

2029890-001 Patient cable, 10 leads, IEC

2029893-001 Patient cable, 10 leads, AHA

Table 5-3. Electrodes

Part number Description

2029891-001 Clamp electrode for limb leads, IEC, set of 4, with labels

2029894-001 Clamp electrode for limb leads, AHA, set of 4, with labels

2029892-001 Bulb electrode for chest leads, set of 6, with labels

5-2 MAC™ 400 2036039-001D

Consumables

Parts List and Replacement

Table 5-4. Consumables

Part number Description

Writer paper

Service manual

217 083 18

Part number Description

2030887-001

2030888-001 Standard thermal recording paper, 80 mm x 15.7 m, 10

Table 5-6. Service manual

Electrode cream, 250-ml refill bottle

Table 5-5. Writer paper

Standard thermal recording paper, 80 mm x 90 mm (width),

10 Zfold

pads/case

rolls/case

Part number Description Language

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

2036039-002 Electronic PDF version of the MAC 400 service

manual and the 12SL Physician’s Guide

2036039-001D MAC™ 400 5-3

English

Parts List and Replacement

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 Brazilian Portuguese (POR)

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

Table 5-7. Operator’s guides

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)

2032589-023 MAC 400 operator’s guide Iberian Portuguese (POR PT)

2032589-024 MAC 400 operator’s manual Chinese (China only)

5-4 MAC™ 400 2036039-001D

Power cords

Part Number Description Country

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

401855-018 Power Cord ST CHINA RA PLUG 10A 250V 2.5M China

401855-101 Power Supply Cord ST CONT EURO 10A 250V 2.5M Europe

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

401855-103 Power Supply Cord ST ITALIAN 10A 250V 2.5M Italy

401855-104 Power Supply Cord ST ISRAELI 10A 250V 2.5M Israel

401855-107 Power Supply Cord ST SWISS 10A 250V 2.5M Switzerland

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

Parts List and Replacement

Table 5-4: Power cords

Central America/

Japan

401855-109 Power Supply Cord ST DANISH 10A 250V 2.5M Denmark

40185-110 Power Supply Cord ST AUSTRALIAN 10A 250V 2.5M Australia

MAC 400 Options

Table 5-5: MAC 400 Options

Part Number Description

2037511-001 Upgrade MAC 400 system with measurement software feature to

12SL-based Interpretation and Analysis software.

2036039-001D MAC™ 400 5-5

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

5-6 MAC™ 400 2036039-001D

Lithium-ion battery, PN 2030912-001

Parts List and Replacement

056

Power supply AC/DC assembly, PN 2030890-001

057

2036039-001D MAC™ 400 5-7

Parts List and Replacement

Bracket kit, PN 2034038-001

058

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

5-8 MAC™ 400 2036039-001D

Main PCB assembly, PN 2031342-001 (non-Chinese systems)

Parts List and Replacement

Main PCB assembly, PN 2031342-101 (Chinese systems only)

059

_____

2036039-001D MAC™ 400 5-9

Parts List and Replacement

Software OTPROM, PN 2034041-002 (non-Chinese systems)

Item Item description

1 IC PROM PDIP 16 MBIT (1MX16)

2 CODE CPU MAC400 V1.02

Software OTPROM, PN 2039125-001 (China systems only)

060

Item Item description

1 IC PROM PDIP 16 MBIT (1MX16)

2 CODE CPU MAC400 V2.00 CHINA

LCD assembly with cable and connector, PN 2030892-001

060

061

5-10 MAC™ 400 2036039-001D

Printer module complete, PN 2030893-001

Parts List and Replacement

Printer door assembly, PN 2031344-001

Item Item description

062

063

1 Printer door part

2 Printer door hinge component (2)

2036039-001D MAC™ 400 5-11

Parts List and Replacement

Top cover assembly with keyboard, PN 2031345-001

Bottom cover kit, PN 2034039-001

064

065

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 2036039-001D

Hardware kit, PN 2034040-001

Parts List and Replacement

066

Fuse kit, PN 2034042-001

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)

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

067

2036039-001D MAC™ 400 5-13

Parts List and Replacement

Clock battery, PN 2036001-001

Paper roll axle, PN 2030889-001

068

069

5-14 MAC™ 400 2036039-001D

A Technical Specifications

2036039-001D 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: 10­leadwire acquisition with programmable lead configuration.

Processing Input impedance

Acquisition and analysis 12 leads—simultaneous

Signal input Type CF according to IEC.

However, not intended for direct
cardiac application.

Digital sampling >1000 samples/second/channel

ECG analysis frequency 500 samples/second/channel Report formats Automatic: simultaneous (short

Dynamic range AC differential +/-5 mV, DC

offset (Polarization voltage) +/­300 mV

Common mode rejection > 100 dB @ 50/60 Hz (AC filter

switched on)

> 10M @ 10 Hz,

Ω

defibrillator protected

Patient leakage

Operating modes Automatic mode (12 lead data),

Lead printout sequence Standard (Einthoven), Cabrera

Heart rate meter 30 to 300 BPM ±2% or ±1

μ

< 10 A

Manual (real-time data),
Arrhythmia (continuous
monitoring)

and long format), sequential
(with or without rhythm);
Manual: 1 or 3 channel real
time printout; Arrhythmia:
continuous monitoring with
event documentation

BPM, whichever is greater.
Heart rates outside this range
do not display.

Resolution

Frequency response 0.01 to 150 Hz

Low cut-off frequency 0.01 Hz, 0.04 Hz, 0.08 Hz or

A-2 MAC™ 400 2036039-001D

5 V

μ

0.16 Hz (-3-dB limits), equivalent
to a time constant of 16s, 4s, 2s,
or 1s

Baseline adjustment Automatic adjustment of the

baseline to the optimal
recording range.

Anti-drift system (ADS) Automatic compensation of

baseline

Lead-fail indication Audible and visual indication of

disconnected electrodes or line
break; each single electrode is
monitored except N/right leg

Technical Specifications

Software options Marquette 12SL ECG-based

measurement package gives QRS,
QT/QTC, PR, P, RR/PP, and P/QRS/T

Paper size Width 80 mm

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

alphanumeric with adjustable contrast

Displayed data Selected lead group, operation mode,

Writer amplitude
accuracy

Keyboard

+/- 5%

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

Battery capacity 100 “automatic” ECG recordings or

Relative humidity

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

2036039-001D MAC™ 400 A-3

Transport/storage 500 to 1060 hPa

Technical Specifications

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 Certifications:

Operating +10° C to 40° C China-specific certifications

a) SFDA Certificate

b) CCC Certificate

c) CMC Certificate

Certifications for all other countries

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 2036039-001D

B Electromagnetic

compatibility
(not applicable
for China)

2036039-001D MAC™ 400 B-1

Electromagnetic compatibility (not applicable for China)

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 declaration­electromagnetic emissions

Emissions test Compliance Electromagnetic environment-guidance

RF emissions

EN 55011

RF emissions

EN 55011

Harmonic Emissions

EN 61000-3-2

Voltage fluctuations/Flicker emissions

EN 61000-3-3

Group 1 The MAC 400 uses RF energy for its internal function.

Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.

Class A The MAC 400 is suitable for use in all establishments other

than domestic and those directly connected to the public low­voltage power supply network that supplies buildings used for

Class A

Complies

domestic purposes.

B-2 MAC™ 400 2036039-001D

Electromagnetic compatibility (not applicable for China)

Guidance and manufacturer’s declaration­electromagnetic immunity

Immunity test EN60601 test level Compliance level Electromagnetic environment-guidance

Electrostatic discharge
(ESD)

EN 61000-4-2

Electrical fast Transient/
burst

EN 61000-4-4

Surge

EN 61000-4-5

Voltage dips, short
interruptions and voltage
variations on power supply
input lines

EN 61000-4-11

Power frequency(50/60
Hz) magnetic field

EN 61000-4-8

± 6 kV contact

± 8 kV air

± 2 kV for power supply
lines

±1 kV for input/output lines

± 1 kV differential mode

± 2 kV common mode

<5% Ut (>95% dip in Ut)
for 0.5 cycles

40% Ut (60% dip in Ut) for
5 cycles

70% Ut (30% dip in Ut) for
25 cycles

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

3 A/m 3 A/m Power frequency magnetic fields should be at

± 6 kV contact

± 8 kV air

± 2 kV for power supply
lines

±1 kV for input/output
lines

± 1 kV differential mode

± 2 kV common mode

<5% Ut (>95% dip in Ut)
for 0.5 cycles

40% Ut (60% dip in Ut) for
5 cycles

70% Ut (30% dip in Ut) for
25 cycles

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

Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.

Mains power should be that of a typical
commercial or hospital environment.

Mains power should be that of a typical
commercial or hospital environment.

Mains power should be that of a typical
commercial or hospital environment. If the
user of the MAC 400 requires continued
operation during power mains interruptions, it
is recommended that the MAC 400 be
powered from an uninterruptable power
supply or a battery.

levels characteristics of a typical location in a
typical commercial or hospital environment.

2036039-001D MAC™ 400 B-3

Electromagnetic compatibility (not applicable for China)

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

EN 61000-4-6

Radiated RF

EN 61000-4-3

3 Vrms

150 KHz to 80 MHz

3V/m

80 MHz to 2.5 GHz

d = 1.2

d = 1.2

80 MHz to 800 MHz

d = 2.3

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).

Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range. Interference may
occur in the vicinity of equipment marked with
the following symbol:

P

P

P

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.

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.

B-4 MAC™ 400 2036039-001D

Electromagnetic compatibility (not applicable for China)

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

output power of

transmitter in watts

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.

150KHz to 80MHz

outside ISM bands

d = 1.2

P P

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

150KHz to 80MHz

outside ISM bands

d = 1.2

80MHz to 800MHz

d = 1.2

P P

800MHz to 2.5GHz

d = 2.3

2036039-001D MAC™ 400 B-5

Electromagnetic compatibility (not applicable for China)

B-6 MAC™ 400 2036039-001D

Index

Index

C
CE marking information 9
E
equipment identification 5
equipment service information 5
equipment symbols 5
F
FRUs

bottom cover kit 12
clock battery 14
complete printer module 11
fuse kit 13
hardware kit 13
LCD assembly with cable and connector 10
lithium-ion battery 7
main PCB assembly 9
paper roll axle 14
power bracket kit 8
power inlet module assembly 6
power supply AC/DC assembly 7
printer door assembly 11
software OTP ROM 10

top cover assembly with keyboard 12
functionality, description 5
M
maintenance

monthly inspections 2
mechanical structure 5
P
parts

ordering 2
PCB assembly 8
power supply 7
R
replacing components 9

12V power supply 18
adjustment instructions 20
battery 10
display 14
PCB assembly 15
power inlet module with toroid display 19
primary fuses 11
RTC battery 16

thermal printer 13
S
setup menu 16
symbols on equipment 5
T
testing

display 21

key and audible tone 20

self test 19

unit functions 20
troubleshooting

battery connection and no power 4

battery error 6

blank display 5

connected to mains but no power 2

green LED but no power 3

incomplete printing error 10

no green LED and no power 2

not printing error 9

paper problem error 8

printer door open error 7

printing only baselines error 11

self test errors 5
V
view, rear 4
view, side 3
view, top 2

2036039-001D MAC™ 400 Index-1

Index

Index-2 MAC™ 400 2036039-001D