GE Mac 400 Servicio

8/19/2019 GE Mac 400 Servicio

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Service Manual

2036039-001 Revision D

GE Healthcare

MAC™ 400Resting ECG Analysis System

Version - Product Code SCT


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T-2 MAC™400 2036039-001D

21 August 2008

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.


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2036039-001D MAC™400 i

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3Safety 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8CE 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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


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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6Patient 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16Replacing 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


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


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2036039-001D MAC™400 1-1

1 Introduction


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1-2 MAC™400 2036039-001D

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.

Manual purpose

This manual provides technical information for service representatives and technical

personnel so they can maintain the equipment to the assembly level. It serves as a

guide for maintenance and electrical repairs that are considered field-repairable.

Where necessary, the manual identifies additional sources of relevant information

and/or technical assistance. See the operator guides for the instructions necessary tooperate the equipment safely in accordance with its function and intended use.

Intended audience

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

equipment.

Intended use

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 recordinformation from adult and pediatric populations. The basic system delivers 3-

channel ECG recordings in automatic and arrhythmia modes and 1- or 3-channel

ECG recordings in manual mode. The arrhythmia detection provides the

convenience of automatic documentation. It is not designed to provide alarms for

arrhythmia detection.

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

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 IntendedUse and Contraindication; removed Equipment Symbols and

added a reference to the Operator's Guides; added a Functional

Checkout procedure.


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Introduction

Safety messages

Additional safety messages that provide appropriate operation information may be

found throughout this manual.

D NGER

EXPLOSION HAZARD — Use near flammables may cause

explosion.

Do not use in the presence of flammable anesthetics, vapors or

liquids.

W RNING

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.


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Introduction

2036039-001D MAC™400 1-5

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 informationRefer 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

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.


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Introduction

Serial number format

026

This manual applies to MAC 400 with product code SCT.

Serial number label (non-China version)

027

Table 1-4: Serial number description

Section Description

A Product Code for MAC 400 device

B Year of manufactureC Fiscal week of manufacture

D Production sequence number

E Manufacturing site code

F Miscellaneous characteristic


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Introduction

2036039-001D MAC™400 1-7

Serial number label (China version)

079

Product label (non-China version)

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

module.

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

Table 1-5: Label format (China version)

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

AB

C

D

E

F

G


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1-8 MAC™400 2036039-001D

Introduction

028

Product Label (Non-China Version)

Product label (China version)The product label is located on the rear side of the device next to the power inlet

module.

080

Product Label (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 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


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Introduction

2036039-001D MAC™400 1-9

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”.

EMC: immunity performance

Users should be aware of known RF sources, such as radio or TV stations and hand-

held or mobile two-way radios, and consider them when installing a medical device

or system. Adding accessories or components, or modifying the medical device orsystem 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 1-6: Product label (China Version)

Section Description

A Product name

B Company name

C Company address

D Rated current

E Fuse

F Type

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

Instrument PartNumber

Description

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

operation with measurement feature (non-Chinese only)


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


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Introduction

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

Instrument Part

NumberDescription


operation with measurement feature (China only )


operation with measurement and interpretation feature (China only )


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2036039-001D MAC™400 2-1

2 Equipment Overview


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2-2 MAC™400 2036039-001D

Equipment Overview

General description

The MAC 400 resting ECG analysis system is a 12-lead, 3-channel system with a

2-line x 16 character display, passive patient cable and battery operation.

Top view

029

Table 2-1: Top view

Name Description

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

operating parameters or control operations.

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

gain, and filter settings.


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Equipment Overview

2036039-001D MAC™400 2-3

Side view

030

Table 2-2: Side view

Name Description

A ECG signal input connector Connect the patient cable.


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Equipment Overview

Rear view

031

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:

Power block

Battery detection circuit

Battery low indication circuit

Table 2-3: Rear view

Name Description

A Product label Displays product name, site of manufacture,

power supply specification, fuse specification

and relevant symbols.

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


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2036039-001D MAC™400 2-5

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

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 non-

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

isolated side.


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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


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Equipment Overview

2036039-001D MAC™400 2-7

Power supply module

The power supply module is mounted on the aluminum plate on the bottom cover.

The power supply module is comprised of the power inlet and +12V power supply.

Power inletThe power inlet includes a three-pin IEC plug and fuse holder for two 2-pole

5x20mm fuse links. This system inlet has a snap fitting.

+12V power supply

The AC/DC power supply is a customized module designed for a universal range of

input voltages. The output supply is in the range of 12V +/- 2%. The specifications

of the power supply are outlined in “Table 2-4: Power supply specifications” on

page 2-7.

Battery

A customized, rechargeable Lithium-Ion battery with built-in 2S protection is

mounted to the battery pocket in the bottom cover. A dedicated battery charger is

used to charge the battery. The battery specifications are listed in “Table 2-5: Battery

specifications” on page 2-7.

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.

Table 2-4: Power supply specifications

Input voltage range 100-240V AC

Frequency 50-60Hz

Full load current 1.67A

Output voltage 12V

Line regulation 12V +/-0.5%

Load regulation 12V +/-2%

Table 2-5: Battery specifications

Rated voltage 7.2V

Battery voltage 5.4-8.4V


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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%.

(non-Chinese systems)

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)

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

systems)

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

1.5A fuse for over-current protection.

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

connected to mains. +12V is the input to the battery charger. LED DS1 and DS2

(shown in the component view in the following graphic) as outlined in “Table 2-6:

Charging conditions” on page 2-8 indicate the charging conditions.

070

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

absent

OFF OFF


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2036039-001D MAC™400 2-9

CPU Motorola MC68832

The Motorola MC68832 (CPU) 32-bit micro controller is the core of the MAC 400

resting ECG analysis system. The CPU interacts with SRAM, PROM, EEPROM,

RTC, FPGA, thermal printer interface, keyboard interface, display interface, audible

tone and DSP (isolated side). A 32.768KHz crystal provides the reference clock

signal for the clock synthesizer of the CPU.

Memory

Memory on the MAC 400 system includes SRAM, PROM, and Serial EEPROM.

PROM stores the code for the CPU and serial EEPROM stores configuration data.

Real-time clock (RTC)

The RTC4574 has an internal 32.768KHz crystal unit. Serial communication

between CPU and RTC4574 through the I/O port of the CPU is used to exchange

time and date information between the CPU and RTC. RTC has an accuracy of +/-

one minute per month. When the device is turned off, the RTC battery powers the

RTC to keep track of the time and date. The battery is a 3V Lithium Ion coin battery

with 255mAH capacity, which can supply power to the clock for a minimum of five

years.

Audible tone (beep) generator

The audible tone generator is F/TCW 05 manufactured by DIGISOUND. The CPU

controls the beep by enabling it under the following circumstances:

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

The beep sounds once every five seconds when the leads are not connected.

The beep sounds once every five seconds to indicate the printer door open,

battery and paper error conditions.

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

within the specified limits.

NOTE

Pressing the QRS beep key disables the audible tone. Turning off the QRS beep

in configuration settings also disables the audible tone for QRS complex.

Keyboard

The keyboard contains the following control keys: up cursor, down cursor, right

cursor, left cursor, enter, config, lead selection, copy, QRS beep, print start/stop.The on/off key is not part of the matrix.

There are two LEDs on the keyboard – one green and one yellow.

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

(all systems)

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

below 6.8V +/- 2%.


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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 non-

isolated sections, except a 68M-ohm resistor provided as a path for the leakage

current. Opto-couplers provide communication between the CPU and DSP. The

transformer provides magnetic coupling between non-isolated +5V supply and

+5V_ISO and +3.3V_ISO for power transfer. The main components of the isolated

side are:

ECG lead connector

Electrostatic discharge protection and conductive noise immunity

Probe ID circuit

Lead fail bias circuit

Right leg drive circuit

Instrumentation amplifiers

Multiplexer

ADC

Voltage reference

DSP


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Equipment Overview

2036039-001D MAC™400 2-11

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 signalchain 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


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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.

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

Connector Signal Name I/O

J11-1 VBAT + I

J11-2 VBAT + I

J11-3 VBAT - I

J11-4 VBAT - I


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 PWMwave integrated by a low pass filter to DC

voltage in the range of 0-2V

0-2V

J8-4 ADR [0] This is the LSB of the address bus. It is

used to select between data and

instruction register

TTL/active high

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

decides whether data is read from the

display or written into the display

TTL/active high

J8-6 DISPLAY The display enable signal generated by

CPU and further processed by FPGA

logic

3.3V/active high

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





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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 J7connector symbols.





J8-15 Unused This pin is not used

J8-16 Unused This pin is not used


Connector Pin Function Description Level/Polarity

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

0-3.8V

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

equal to 5V

5V

J7-3 VHE I The output of cue mark sensorconnected to the input of the

comparator, which is part of the cue

mark sensor circuit

800mV-5V

J7-4 SW I One terminal of the door sensor

input to door sensing circuit

TTL/active high

J7-5 SW I Other terminal of door sensor

connected to ground

0V

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


J7-8 DI O Data input to shift register TTL

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

J7-10 GND Ground 0V

J7-11 GND Ground 0V

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


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Equipment Overview

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.



J7-15 VDD O VCC for logic 5V

J7-16 TM I Thermistor



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

J7-24 DO I Data out signal TTL



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

Table 2-10: J7 connector symbols




J9-1 GND Ground connection 0V

J9-2 Not connected

J9-3 Not connected



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2036039-001D MAC™400 2-15

ECG lead connector

J1 is a 14-pin connector, which connects ECG leads to the MAC 400 system PCB.

The interface signals are identified in “Table 2-12: J1 interface signals” on page 2-

16.

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

J9-6 ROW1 I Row 1 connection




J9-10 COLUMN5 O Column 5 connection







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

lights up when a valid mains is

connected to the device

J9-18 Battery indication

LED

O Non-Chinese systems:

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%.




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Equipment Overview

Preparation for use

The MAC 400 resting ECG analysis system does not require installation. However,

you may want to customize the system settings. Once the operating parameters are

set, the system saves the settings as the default parameters and activates them each

time the system is turned on.

The Setup menu overview

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

want.

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

item is Language.

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

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

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

J1-11 LL

J1-12 V1

J1-13 Not connected

J1-14 RL


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Equipment Overview

2036039-001D MAC™400 2-17

4. Press enter to confirm your selection.

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

Setting optionsOperating parameters can be customized using the setup menu. To change or set

options, follow the steps for each menu item. Following are several of the most

common settings. For more information about setting operating parameters, see the

“MAC 400 Resting ECG Analysis System Operator’s Guide”.

To access the options menu and initiate any of the following setting selections, press

the configuration key.

Selecting a language

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

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

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


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 .


Setting the date and time for printed ECG reports

To set the date:

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


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Equipment Overview

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


To set the time:

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

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


Selecting heart rate limit values

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

2. Use the right/left cursor to change the low limit value in increments of 5

BPM, between 30 and 120 BPM.


4. Use the right/left cursor to change the high limit value (between 80 and

240 BPM).


NOTE

After setting these options, you must press configuration to save the

options and exit the setup menu.

Printing settings

It is recommended that you print the current settings of the system before

performing any maintenance.

1. Press configuration to enter the setup menu.

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

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

settings.


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Equipment Overview

2036039-001D MAC™400 2-19

Restoring options

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

Restoring the serial number

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

1. Turn off the power.

2. Press and hold the enter and copy keys together and turn on the

device. Keep the key combination depressed until Enter serial number displays.

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

and select the characters with the start/stop key. After you enter the

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

Restoring the interpretation option

When the main PCB is replaced, use the option activation code to restore the

original option. The option code label is located on the side of the device near the

patient cable connector.

1. Turn off the power.

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.

Diagnostic tests

All messages displayed during self tests are in English. The system menu guides youthrough 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


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Equipment Overview

RAM test

DSP test

If any of these tests fail, the corresponding error code displays the message: Test

failed...4 ROM (2 RAM, 5 DSP) error .

Device testsThe 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


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Equipment Overview

2036039-001D MAC™400 2-21

Display test

Device test DISPLAY TEST displays. To test the display:

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

2. Press the right cursor key. Two rows of 16 black squares display.

3. Press the left cursor key to clear the display.

4. Press the enter key to exit and move to the next test.

Motor 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.

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

Recording test

Device test RECORDING TEST displays. To test the recording:

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

2. 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.

Results test

Device test RESULTS displays. Press the start/stop key to print one page results.

The printed output supplies data on the software contained in the unit (reference

number, version number, 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.


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Equipment Overview


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2036039-001D MAC™400 3-1

3 Maintenance


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3-2 MAC™400 2036039-001D

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.

W RNING

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.


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Maintenance

2036039-001D MAC™400 3-3

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

line and the AC switch is On.

Exterior cleaning

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

Use a clean, soft cloth and water with a mild detergent. Wring excess water

from the cloth and wipe down the exterior surfaces of the device.

Dry the surfaces with a clean cloth or paper towel.

Interior cleaning

Check for dust on the interior components and clean as needed with commercially

available compressed air.

Clean the thermal printhead periodically to ensure good print quality and long

printer life. To clean the thermal printhead:

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

2. Open the printer door and separate the platen from the printhead.

3. Wipe the glazed surface of the thermal printhead gently with cotton swabs and

ethyl alcohol.

4. When the surfaces are dry, fix the platen in place and close the printer door.

NOTE

Do not hit the thermal printhead with anything hard.

Do not use sand paper on the thermal printhead.

Do not add any unnecessary force on the thermal printhead.

Electrical safety tests

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

1. The tests should be performed with safety testing 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.


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3-4 MAC™400 2036039-001D

Maintenance

071

Recommended test equipment

Safety tester for measurements according to 60601-1.

Testing connector as described for the individual tests.

GE recommended test schedule

After initial setup.

Once every 12 months thereafter as part of a regular maintenance plan.

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.


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Maintenance

2036039-001D MAC™400 3-5

Leakage current tests

The following electrical diagram shows the Measuring Circuit [M] required for

leakage current. The reading in mV corresponds to mA (leakage current). The safety

tester instruments generally work with this Measuring Circuit [M] and the displayed

values are converted to leakage current.

033

Earth leakage (AC line) current test

078

This test measures leakage current of the device’s internal power supply. The device

has to be turned on and off, and connected to your safety-testing equipment.

Measurements should be taken under the following conditions (refer to the safety

tester diagram):

Device in “ON” state

Polarity switch NORM and RVS

S1 (neutral) closed and open

GND switch open


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Maintenance

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

Enclosure (chassis) leakage current test

034

This test measures leakage current from the chassis to ground during normal

condition (N.C.) and single fault conditions (S.F.C.). In all cases, the leakage current

is measured from any exposed conductive parts to ground; the device has to be

turned on and off, and connected to your safety-testing instrument.

During N.C., measurements should be taken under the following conditions (refer to

the safety tester diagram):



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):



GND switch closed, S1 (neutral) open

GND switch open, S1 (neutral) closed


N.C. S.F.C.

Polarity: NORM & RVS

S1 (neutral): closed

GND: open


S1 (neutral): open

GND: open

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

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

300 uA (UL)


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Maintenance

2036039-001D MAC™400 3-7

Patient leakage current tests

These tests measure leakage current of the device’s floating inputs

(patient connections) to ground.

Patient leakage current to ground

077

This test measures leakage current from the floating input (patient connection) to

ground during normal condition (N.C.) and single fault condition (S.F.C.). In all

cases, the leakage current is measured from the floating input to ground: The device

has to be turned on and off, and connected to your safety testing instrument.

During N.C., measurements should be taken under the following conditions (refer to

the safety tester diagram):



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):


N.C. S.F.C.



GND: closed


S1 (neutral): closed I open

GND: open I closedTotal tests/combinations: 2 Total tests/combinations: 2

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

300 uA (UL)


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3-8 MAC™400 2036039-001D

Maintenance


GND switch closed, S1 (neutral) open

GND switch open, S1 (neutral) closed


Patient leakage current, mains on applied part

035

W RNING

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.

N.C. S.F.C.



GND: closed


S1 (neutral): closed I open

GND: open I closed


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


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Maintenance

2036039-001D MAC™400 3-9

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):



S1 (neutral) open

GND switch closedThe test has failed if the measured values are greater than:

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.

W RNING

OPERATOR SAFETY — Repairing device when powered on

may cause injury.

Turn off the device before replacing components.

N.C. S.F.C.

N/A Polarity: NORM & RVS

S1 (neutral): open

GND: closed


N/A 50 uA (IEC & UL)


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3-10 MAC™400 2036039-001D

Maintenance

Safety instructions

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

Only approved personnel may conduct repairs.

Before opening the device, turn off the power and disconnect the mains plug

from the power inlet module. Never connect the mains plug when the device isopen.

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.

Replacing the battery

036


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Maintenance

2036039-001D MAC™400 3-11

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

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.

UTION

EQUIPMENT PERFORMANCE — Use of unapproved

components may interfere with device performance.

Only use fuses indicated on the product label.


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3-12 MAC™400 2036039-001D

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.


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3-14 MAC™400 2036039-001D

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.


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Maintenance

2036039-001D MAC™400 3-15

Replacing the PCB assembly

041

NOTE

If possible, print out the current settings before replacing the PCB assembly. Forinformation 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.


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3-16 MAC™400 2036039-001D

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

042

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 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.


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Maintenance

2036039-001D MAC™400 3-17

4. Remove the two solder patches.

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

6. Replace the two solder patches.

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

key.

8. Adjust the time and date.

Replacing the OTPROM

075

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


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.


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3-18 MAC™400 2036039-001D

Maintenance

Replacing the 12V power supply

0432

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


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.


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Maintenance

2036039-001D MAC™400 3-19

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.


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3-20 MAC™400 2036039-001D

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

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


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Maintenance

2036039-001D MAC™400 3-21

Tools needed

1. Phillips screwdriver

2. Anti-static wrist strap

3. Service manual as needed for reference

FRU Replacement

FRU Description Tools Visual InspectionElectrical Safety

TestCheckout Procedure

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

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

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

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 InspectionElectrical Safety

TestCheckout Procedure

No parts replaced 3 3,5 N/A 1

Software update - Enable interpretation

option

3 N/A N/A 3

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


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3-22 MAC™400 2036039-001D

Maintenance

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

Visual inspection

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.


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Maintenance

2036039-001D MAC™400 3-23

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.

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.

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 moreinformation.

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.

Electrical Safety Checks

Step Condition1 UUT - ON2 Result Leakage Current Limits

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


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

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


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Maintenance

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

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


Patient Leakage Current To Ground


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


Ground Resistance Resistance

1 AC mains power cord ground prong to

exposed metal surface (ground lug)

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

1 NC = Normal Condition; SFC = Single Fault Condition; N/A = Not Applicable2 UUT = Unit Under Test

Electrical Safety Checks

Step Condition1 UUT - ON2 Result Leakage Current Limits


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2036039-001D MAC™400 4-1

4 Troubleshooting


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4-2 MAC™400 2036039-001D

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. Toreplace components, see “Opening the device” on page 3-12.

045


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Troubleshooting

2036039-001D MAC™400 4-3

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.

046


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4-4 MAC™400 2036039-001D

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


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Troubleshooting

2036039-001D MAC™400 4-5

Blank display

If the device is on and the audible tone (beep) sounds but the display is blank, follow

the steps in the following flowchart to pinpoint the faulty component.

048

Errors detected during self test

If any errors are detected during self-test, the error message Test failed… in addition

to the error code and brief description display.

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.


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4-6 MAC™400 2036039-001D

Troubleshooting

Battery error

The MAC 400 device can only print when it is powered by the ba

Documents

GE Mac 400 Servicio