GE Mac 400 Servicio

GE Healthcare

MAC™ 400 Resting ECG Analysis System Version - Product Code SCT

Service Manual 2036039-001 Revision D

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 own ers. ©2007, 2008. General Electric Company. All Rights reserved.

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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

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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6 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 not mains no t turn . . . on . . .. .. .. .. .. .. ... .. .. .. .. .. .. .. .. .. .. .. .4-2 4-2 Green LED does lightbut up does and device doesonnot. .turn 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3 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 declarationelectromagnetic emissions . . . . . . . B-2 Guidance and manufacturer’s declaration-elec tromagnetic immunity . . . . . . . . . B-3 Recommended separation distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

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iv

MAC™ 400

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1

2036039-001D

Introduction

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.

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

Date

Comment

A

2 July 2007

Initial release of this document.

B

5 November 2007

C

2 January 2008

Edited FRU part number. Added special content for China systems.

D

21 August 2008

Added new product label for non-China units; added Intended Use and Contraindication; removed Equipment Symbols and added a reference to the Operator's Guides; added a Functional Checkout procedure.

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

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

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 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.

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Introduction

Contraindications 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.

Conventions Table 1-2: Conventions Bold t ext

Indicates keys on the keyboard, text to be entered, or hardware terms such as buttons or switches on the equipment.

Italicized t ext

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

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

Table 1-3: Hazard terms Term

2036039-001D

Definition

DANGER

Indicates an imminent hazard which, if not avoided, will result in serious injury or death.

WARNING

Indicates a potential hazard or unsafe practice which, if not avoided, could result in serious injury or death.

CAUTION

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

NOTE

Provides application tips or other useful information to assure that you get the most from your equipment.

MAC™ 400

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Introduction

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

EXPLOSION HAZARD — Use near flammables may cause explosion. Do not use in the presence of flammable anesthetics, vapors or liquids.

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:

1-4



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.

MAC™ 400

2036039-001D

Introduction

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

025

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

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

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Introduction

Serial number format

026

Table 1-4: Serial number description Section

Description

A

Product Code for MAC 400 device

B

Yearofmanufacture

C

Fiscal week of manufacture

D

Production sequence number

E

Manufacturing site code

F

Miscellaneousc haracteristic

This manual applies to MAC 400 with product code SCT.

Serial number label (non-China version)

027

1-6

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Introduction

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

Description

A

Date of manufacture in the format YYYY-MM

B

Partnumberofproduct

C

Productcodedescription

D

Serial number described above

E

Barcode representation of serial number

Serial number label (China version)

E D C B A

F G

079

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

Description

A

Date of manufacture in the format YYYY-MM

B

Partnumberofproduct

C

Productionlicense

D

Registration of product standards

E

Productregisternumber

F

Serialnumber

G

Barcode representation of serial number

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

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Introduction

028

Product Label (Non-China Version)

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

Description

A

Product name (MAC 400)

B

Siteofmanufacture

C

Ratingof12Vpowersupply

D

Dimensionandratingoffuse

E

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

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

A B C D

F

E 080

Product Label (China Version)

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MAC™ 400

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Introduction

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

Description

A

Product name

B

Companyname

C

Companyaddress

D

Ratedcurrent

E

Fuse

F

Type

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 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 syste ms. 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

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Description

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)

MAC™ 400

1-9

Introduction

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

1-10

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 )

MAC™ 400

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2

2036039-001D

Equipment Overview

MAC™ 400

2-1

Equipment Overview

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

Top view

029

Table 2-1: Top view Name

2-2

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

Side view

030

Table 2-2: Side view Name A

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ECG signal input connector

MAC™ 400

Description Connect the patient cable.

2-3

Equipment Overview

Rear view

031

Table 2-3: Rear view Name A

Product label

B

AC mains connector

Description Displays product name, site of manufacture, power supply specification, fuse specification and relevant symbols. 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:

2-4



Power block



Battery detection circuit



Battery low indication circuit

MAC™ 400

2036039-001D

Equipment Overview



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 and converts to digital format. the lineand frequency component and the itmuscle artifactsit from the ECG dataThen, are filtered, 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.

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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

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MAC™ 400

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Equipment Overview

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

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

+12V power supply The AC/DC power supply is a customized module designed for a universal range of input voltages. The output supply is in the range of 12V +/- 2%. The specifications of the power supply are outlined in “Table 2-4: Power supply specifications” on page 2-7.

Table 2-4: Power supply specifications Input voltage range

100-240V AC

Frequency

50-60Hz

Full load current

1.67A

Outputvoltage

12V

Line regulation

12V +/-0.5%

Load regulation

12V +/-2%

Battery A customized, rechargeable Lithium-Ion battery with built-in 2S protection is mounted to the battery pocket in the bottom cover. A dedicated battery charger is used to charge the battery. The battery specifications are listed in “Table 2-5: Battery specifications” on page 2-7.

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.

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.

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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%. (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 Chargoepr eration

D S2

Charge progress in

ON

Charge complete

2-8

OFF OFF

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

MAC™ 400

D S1

OFF

ON OFF

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Equipment Overview

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. 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. 

Thesystems) green LED indicates that the system is connected to active mains. (all 

2036039-001D

On non-Chinese systems, the yellow LED indicates that the battery voltage is below 6.8V +/- 2%.

MAC™ 400

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Equipment Overview



A yellow LED will illuminate continuously when battery is fully charged or not charging. It will flash when ba ttery 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:

2-10



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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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

2036039-001D

SignaN l ame

I/O

J10-1

GND

I

J10-2

GND

I

J10-3

+12V

I

J10-4

+12V

I

MAC™ 400

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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.

Table 2-8: J11 interface signals Connector

SignaN l ame

J11-1

VBAT +

J11-2

I/O I

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 2-9: J8 connector signals

2-12

ConnectorPin

Function

J8-1

GND

Description Groundpinofdisplay

Level/Polarity 0V

J8-2 J8-3

+5V CONTRAST

VCC of display 5V 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

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

J8-8

DATA [9]


J8-9

DATA [10]


J8-10

DATA [11]


MAC™ 400

0-2V

2036039-001D

Equipment Overview

Table 2-9: J8 connector signals ConnectorPin

Function

Description

Level/Polarity

J8-11

DATA [12]


J8-12

DATA [13]


J8-13

DATA [14]


J8-14

DATA [15]


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.

Table 2-10: J7 connector symbols ConnectorPin

Function

J7-1

PHK

I

The cathode of LED in the cue mark sensor

J7-2

VSEN

O

TheVCCofcuemarksensorandis equal to 5V

J7-3

VHE

I

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

J7-4

SW

I

Oneterminalofthedoorsensor input to door sensing circuit

J7-5

SW

I

Otherterminalofdoorsensor connected to ground

J7-6

VH

O

J7-7

VH

O

Printheadvoltagesupply

6-8.4V

J7-8

DI

O

Datainputtoshiftregister

TTL

CLK

O

J7-9 J7-10

GND

J7-11

GND

J7-12

2036039-001D

STB 5

I/O

Description


Clockinputtoshiftregister Ground Ground

O

MAC™ 400

Strobe signal

Level 0-3.8V 5V 800mV-5V

TTL/active high 0V 6-8.4V

TTL,L->H 0V 0V TTL, active high

2-13

Equipment Overview

Table 2-10: J7 connector symbols ConnectorPin J7-13 J7-14 J7-15

Function

I/O

Level

STB4

O

Strobesignal

TTL,activehigh

STB3

O

Strobesignal

TTL,activehigh

O

VCC for logic

VDD

J7-16

TM

J7-17

STB2

O

J7-18

STB1

O

J7-19

AEO2

O

AEO1

O

J7-20

Description

I

5V

Thermistor Strobesignal

TTL,activehigh

Strobesignal

TTL,activehigh

Heaterelementsblockselect

TTL,activelow

Heaterelementsblockselect

TL,activelow

J7-21

GND

Ground

0V

J7-22

GND

Ground

0V

J7-23

LAT

O

Latchsignal

J7-24

DO

I

Data out signal

TTL,activelow TTL

J7-25

VH

O


6-8.4V

J7-26

VH

O


6-8.4V

J7-27

MTA

O

OneendofphaseAwinding

6-8.4V

J7-28

MTA*

O

OtherendofphaseAwinding

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.


Function

J9-1

GND

J9-2

Not connected

J9-3

Not connected

J9-4

2-14

I/O

GND

MAC™ 400

Description

Level

Ground connection

0V

Ground connection

0V

2036039-001D

Equipment Overview


Function

I/O

Description

J9-5

On/Offswitch

I

On/Offswitchindependentofmatrix

J9-6

ROW1

I

Row1connection

J9-7

ROW2

I

Row2connection

J9-8

ROW3

I

Row3connection

J9-9

ROW5

I

Row5connection

J9-10

COLUMN5

O

Column5connection

J9-11

COLUMN1

O

Column1connection

J9-12

COLUMN2

O

Column2connection

J9-13

ROW4

I

Row4connection

J9-14

COLUMN3

O

Column3connection

J9-15

COLUMN4

O

J9-16

GND

Column4connection Ground connection

J9-17

Main indication LED

J9-18

Battery indication LED

O

O

Level

0V

Connected to the green LED which lights up when a valid mains is connected to the device Non-Chinesesystems: Connected to the yellow LED whic h lights up when the battery voltage goes below 6.8V +/- 2% Chinese systems: Connected to yellow LED whic h will illuminate continuously when battery is fully charged or not charging or it will flash when battery voltage falls below 6.8V +/- 2%.

ECG lead connector J1 is a 14-pin connector, which connects ECG leads to the MAC 400 system PCB. The interface signals are identified in “Table 2-12: J1 interface signals” on page 216.

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MAC™ 400

2-15

Equipment Overview

Table 2-12: J1 interface signals Connectorpin

Function

J1-1

V2

J1-2

V3

J1-3

V4

J1-4

V5

J1-5

V6

J1-6

Cableshield

J1-7

Cableshield

J1-8

GND

J1-9

RA

J1-10

LA

J1-11

LL

J1-12

V1

J1-13

Notconnected

J1-14

RL

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

The Setup menu overview Use the setup menu to navigate between system settings and select the options you want. 1.

Press the

configuration key to access the setup menu. The first menu

item is Language.

2-16

2.

Use the

up/down cursor to select a menu item.

3.

Use the

left/right cursor to select the desired setting.

MAC™ 400

2036039-001D

Equipment Overview

4.

Press

enter to confirm your selection.

5.

Press the

configuration key to save settings and exit the setup menu.

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

configuration key.

Selecting a language You can select the language for the display text and printed ECG reports. 1.

Use the

up/down cursor to select Language.

2.

Use the

right/left cursor to choose your preferred language.

3.

Press


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


Setting the date and time for printed ECG reports To set the date: 1.

2036039-001D

Use the

up/down cursor to select Date.

MAC™ 400

2-17

Equipment Overview

2.

Use the

3.

Press

right/left cursor to set the date. 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


Selecting heart rate limit values 1.

Use the

up/down cursor to select HR control.

2.

Use the

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

BPM, between 30 and 120 BPM. 3.

Press

4.

Use the


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

240 BPM). 5.

Press


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

3.

Select Yes and press

up/down cursor to navigate to Print. enter to confirm your selection and print the

settings.

2-18

MAC™ 400

2036039-001D

Equipment Overview

Restoring options When the main PCB assembly is replaced, you need to restore the srcinal 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 srcinal 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 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: 

2036039-001D

ROM test

MAC™ 400

2-19

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 tests 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

2-20

Displam y essage

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

MAC™ 400

2036039-001D

Equipment Overview

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

3.

mm/s and the gain 5, 10, or 20mm/mV. 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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MAC™ 400

2-21

Equipment Overview

2-22

MAC™ 400

2036039-001D

3

2036039-001D

Maintenance

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.

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.



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.

Visual inspection

 

3-2

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.

MAC™ 400

2036039-001D

Maintenance



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. 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 606011. 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

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.

3-4



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.

MAC™ 400

2036039-001D

Maintenance

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):

2036039-001D



Device in “ON” state



Polarity switch NORM and RVS



S1 (neutral) closed and open



GND switch open

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

S1 (neutral): open

GND: open

GND: open

Totaltests/combinations:2 500uA(IEC)

Totaltests/combinations:2 1,000uA(IEC&UL)

300 uA (UL)

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): 


 

Polarity switch NORM and RVS GND switch closed, S1 (neutral) open



GND switch open, S1 (neutral) closed


3-6

MAC™ 400

2036039-001D

Maintenance

N.C.

S.F.C.




S1 (neutral): closed I open

GND: closed

GND: open I closed

Total tests/combinations: 2 100uA(IEC&UL)

Total tests/combinations: 2 500uA(IEC) 300 uA (UL)

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

Patient leakage current to ground

077

This test measures leakage current from the floating input (patient connection) to ground during normal condition (N.C.) and single fault condition (S.F.C.). In all cases, the leakage current is measured from the floating input to ground: The device has to be turned on and off, and connected to your safety testing instrument. During N.C., measurements should be taken under the following conditions (refer to the safety tester diagram): 







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): 

2036039-001D


MAC™ 400

3-7

Maintenance






GND switch closed, S1 (neutral) open



GND switch open, S1 (neutral) closed


N.C.

S.F.C.




S1 (neutral): closed I open

GND: closed

GND: open I closed

Totaltests/combinations:2 10uA(IEC&UL)

Totaltests/combinations: 4 50uA(IEC&UL)

Patient leakage current, mains on applied part

035

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 lin e 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 th e 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 closed


N.C. N/A

S.F.C. Polarity: NORM RVS & S1 (neutral): open GND: closed

Total tests/combinations: 0 N/A

Total tests/combinations: 2 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.

OPERATOR SAFETY — Repairing device when powered on may cause injury. Turn off the device before replacing components.

2036039-001D

MAC™ 400

3-9

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 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 srcinal 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

3-10

MAC™ 400

2036039-001D

Maintenance

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.

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 b attery as d escribed 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.

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

Maintenance

Replacing the thermal printer

039

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 pla ten on th e printer door and press it into po sition.

Ensure that the platen gear aligns with the gears of the thermal printer.

2036039-001D

MAC™ 400

3-13

Maintenance

Replacing the display

040

3-14

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.

MAC™ 400

2036039-001D

Maintenance

Replacing the PCB assembly

041

If possible, print out the current settings before replacing the PCB assembly. For information about the configuration settings, see “Printing settings” on page 218. 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.

7.

Orient the new main PCB assembly, align the mounting holes with those in the

8.

aluminum plate, and fasten the new PCB assembly to the plate with the screws. Re-fasten the display and display bracket to the PCB and plate with the screws.

Return the PCB assembly to the factory in ESD packaging.

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 dev ice to the lower sec tion with the four screws. 11. Replace the battery in the batt ery pocket, slide on the co ver 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 (o ptional) as described in “Restoring options” on page 2-19. 14. Adjust the display contrast as described in “Adjustment instructions” on page 320. 15. Adjust the time and date. 16. If possible, set the confi guration to the previous us er 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.

Dispose of battery according to local municipal waste guidelines.

3-16

MAC™ 400

2036039-001D

Maintenance

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

2036039-001D

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.

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. power Connect themodule, black wire the po wer to the marked ‘N’ of the inlet andofconnect the supply white wire toter theminal 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. 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.

Use care to ensure that the power inlet connections are properly assembled as indicated in drawing. 10. Connect the earthing cable of the toroid su pply to the therma l printer base mounting hole. 11. Replace the shield and po wer supply assembly by turning it over and a ligning the screw holes.

Before tightening the shield screws, confirm that the power supply cable and grounding cable are properly positioned. 12. Replace the screws fastening the power inle t bracket to the lowe r housing. 13. Replace the screw hold ing the ground cable to the print er 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

Maintenance

FRU Replacement FRUDescription

Tools

PowerInletmoduleassembly

1to6and8

Battery assembly

93,1,

Powersupplymoduleassembly Bracket assembly kit

1,3,5

1to6and8

and to 618

3

1,2

3

N/A

3

N/A

LCD assembly with cable and connector

3 2. 1.

3

N/A

1, 3, 8

1, 3, 8

Bottom cover assembly

to and 16 8

Hardware kit

3

3, 4, 5

Clock battery assembly

1, 2, 3, 7, 8

1, 10 10 1, 1, 8, 11

1, 2

to 112 N/A

3 1,

Axle for paper roll assembly

9 4, 1,

N/A

3

3

1, 11

N/A

3

3 1,

Fuse kit

1

N/A

3

Top cover assembly

1and8to12

to 12 1

3

83, 1,

51,

1, 2

1, 2, 3, 8

Printer door assembly

1

N/A

3

1

N/A

3

Checkout Procedure

1

N/A

SoftwareOTPROM assembly

Printer module assembly

Electrical Safety Test

1,2

3

31,

Main PCB assembly

VisualInspection

1, 6

3

N/A

N/A

Other Service Events FRUDescription parts No replaced

Tools 3

Software update - Enable interpretation option PostInstallationCheckout Annual Electrical Safety tests

VisualInspection 3,5

3 2,3,4,5,6,8

N/A N/A

2,3

2, 3, 4, 5, 6, 8

Electrical Safety Test 1 N/A

1,2 3

Checkout Procedure

3 1,11

1, 2

1, 11

Tools needed

2036039-001D

1.

Phillips screwdriver

2.

Anti-static wrist strap

3.

Service manual as needed for reference

MAC™ 400

3-21

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

3-22

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.

MAC™ 400

2036039-001D

Maintenance

Diagnostic tests 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 s uccessful. See “Results test” on page 2-21 for more information.

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 exp osed metal is prop erly grounded. See “Ground resistance test” on page 3-4 for more information.

Electrical Safety Checks Condition1

Step

UUT - ON2

Result

Leakage Current Limits

Earth Leakage Current 1

Forward Polarity

NC

______

μΑ

Pass/Fail

300 μΑ

2

NeutralOpen,ForwardPolarity

SFC

______

μΑ

Pass/Fail

1,000 μΑ

3

NeutralOpen,ReversePolarity

SFC

______

μΑ

Pass/Fail

1,000 μΑ

4

Reverse Polarity

NC

______ μΑ

Pass/Fail

300 μΑ

Forward Polarity

NC

______

μΑ

Pass/Fail

100 μΑ

2


SFC

______

μΑ

Pass/Fail

300 μΑ

3

GroundOpen,ForwardPolarity

SFC

______

μΑ

Pass/Fail

300 μΑ

Enclosure Leakage Current 1

2036039-001D

MAC™ 400

3-23

Maintenance

Electrical Safety Checks Condition1

Step

UUT - ON2

Result

Leakage Current Limits

4

GroundOpen,ReversePolarity

SFC

______

μΑ

Pass/Fail

300 μΑ

5


SFC

______

μΑ

Pass/Fail

300 μΑ

Reverse Polarity

NC

______ μΑ

Pass/Fail

100 μΑ

6

Patient Leakage Current To Ground 1

Forward Polarity

NC

______

μΑ

Pass/Fail

10 μΑ

2


SFC

______

μΑ

Pass/Fail

50 μΑ

3

GroundOpen,ForwardPolarity

SFC

______

μΑ

Pass/Fail

50 μΑ

4

GroundOpen,ReversePolarity

SFC

______

μΑ

Pass/Fail

50 μΑ

5


SFC

______

μΑ

Pass/Fail

50 μΑ

6

Reverse Polarity

NC

______ μΑ

Pass/Fail

10 μΑ

Ground Resistance 1

3-24

AC mains power cord ground prong to exposed metal surface (ground lug)

Resistance N/A

1

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

2

UUT = Unit Under Test

______ Ω

MAC™ 400

Pass/Fail

Lessthan200m Ω

2036039-001D

4

2036039-001D

Troubleshooting

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

Troubleshooting

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

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

Troubleshooting

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

048

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

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

Troubleshooting

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

050

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

Troubleshooting

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.

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

Troubleshooting

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

054

2036039-001D

MAC™ 400

4-11

Troubleshooting

4-12

MAC™ 400

2036039-001D

5

2036039-001D

Parts List and Replacement

MAC™ 400

5-1


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

Accessory kits Table 5-1. Accessory kits Parnt umber

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).

2035819-002

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

Patient Cables Table 5-2. Patient Cables Parnt umber

Description

2029890-001

Patient cable, 10 leads, IEC

2029893-001

Patient cable, 10 leads, AHA

Electrodes Table 5-3. Electrodes

5-2

Parnt umber

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

MAC™ 400

2036039-001D


Consumables

Table 5-4. Consumables Parnt umber

Description

217 083 18

Electrode cream, 250-ml refill bottle

Writer paper

Table 5-5. Writer paper Parnt umber

Description

2030887-001

Standard thermal recording paper, 80 mm x 90 mm (width), 10 Zfold pads/case

2030888-001

Standard thermal recording paper, 80 mm x 15.7 m, 10 rolls/case

Service manual Table 5-6. Service manual Parntumber

2036039-001D

Description

2036039-001

Paper/printed version of the MAC 400 service manual

2036039-002

Electronic PDF version of the MAC 400 service manual and the 12SL Physician’s Guide

MAC™ 400

Language English English

5-3


Operator’s guides Table 5-7. Operator’s guides PartNumber

5-4

Description

Language

2032589-001

MAC 400 operator’s guide

English (ENG)

2032589-002


German (GER)

2032589-003


French (FRE)

2032589-004


Dutch (DUT)

2032589-005


Italian (ITA)

2032589-006


Spanish (SPA)

2032589-007


Brazilian Portuguese (POR)

2032589-008


Russian (RUS)

2032589-009


Hungarian (HUN)

2032589-010


Polish (POL)

2032589-011


Czech (CZE)

2032589-012


Chinese (CHS)

2032589-013


Slovakian (SLO)

2032589-014


Greek (GRE)

2032589-015


Korean (KOR)

2032589-016


Bulgarian (BUL)

2032589-017


Turkish (TUR)

2032589-018

MAC400operator’sguide

2032589-019


2032589-020


2032589-023

MAC400operator’sguide

IberianPortuguese(PORPT)

2032589-024

MAC400operator’smanual

Chinese(Chinaonly)

MAC™ 400

Lithuanian(LIT) Latvian (LAT) Estonian (EST)

2036039-001D


Power cords Table 5-4: Power cords PaNrtumber

Description

Country

405535-006

Power supply cord RA Hospital Grade 13A 125 V 10 FT

401855-018

PowerCordSTCHINARAPLUG10A250V2.5M

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

PowerSupplyCordSTITALIAN10A250V2.5M

Italy

401855-104

PowerSupplyCordSTISRAELI10A250V2.5M

Israel Switzerland

401855-107

PowerSupplyCordSTSWISS 10A250V 2.5M

2035953-001

PowerSupplyCordSTINDIAN6A250V2.5M

401855-109

PowerSupplyCordSTDANISH10A250V2.5M

40185-110

Power Supply Cord ST AUSTRALIAN 10A 250V 2.5M

North America/ Central America/ Japan

India Denmark Australia

MAC 400 Options Table 5-5: MAC 400 Options ParN t umber

Description

2037511-001

2036039-001D

Upgrade MAC 400 system with measurement software feature to 12SL-based Interpretation and Analysis software.

MAC™ 400

5-5


Field replaceable units (FRUs) Power inlet module assembly, PN 2035715-001

055

Item

5-6

Item description

1

Powerinletmodule

2

Fuseholder

3

Toroidassembly

MAC™ 400

2036039-001D


Lithium-ion battery, PN 2030912-001

056

Power supply AC/DC assembly, PN 2030890-001

057

2036039-001D

MAC™ 400

5-7


Bracket kit, PN 2034038-001

058

Item

5-8

Item description

1

Aluminumshieldplate

2

Powersupplymountingplate

3

Powerinmoduleholder

4

Printermountingbase

5

Display mounting bracket (small LCD)

6

Patientcableconnectorholder

7

Insulationboard-shieldplateAL

MAC™ 400

2036039-001D


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

059

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

_____

2036039-001D

MAC™ 400

5-9


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

060

Item

Item description

1

ICPROMPDIP16MBIT(1MX16)

2

CODECPUMAC400V1.02

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

060

Item

Item description

1

ICPROMPDIP16MBIT(1MX16)

2

CODECPUMAC400V2.00CHINA

LCD assembly with cable and connector, PN 2030892-001

061

5-10

MAC™ 400

2036039-001D


Printer module complete, PN 2030893-001

062

Printer door assembly, PN 2031344-001

063

Item

2036039-001D

Item description

1

Printerdoorpart

2

Printerdoorhingecomponent(2)

MAC™ 400

5-11


Top cover assembly with keyboard, PN 2031345-001

064

Bottom cover kit, PN 2034039-001

065

Item

5-12

Item description

1

Bottomcover

2

Rubber foot - SJ5012, 12.7mm DIA, 3.5mm thick (4)

3

Batterycover

4

Paperliftingtape

MAC™ 400

2036039-001D


Hardware kit, PN 2034040-001

066

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 kit, PN 2034042-001 Fuse 2.0A SLO-BLO 250V 5x20mm (2)

067

2036039-001D

MAC™ 400

5-13


Clock battery, PN 2036001-001

068

Paper roll axle, PN 2030889-001

069

5-14

MAC™ 400

2036039-001D

A

2036039-001D

Technical Specifications

MAC™ 400

A-1


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.

Common mode rejection

> 100 dB @ 50/60 Hz (AC filter switched on)

Processing

Input impedance

> 10M Ω @ 10 Hz, defibrillator protected

Acquisition and analysis

12 leads—simultaneous

Patient leakage

<10 μA

Signalinput

TypeCFaccordingtoIEC. However, not intended for direct cardiac application.

Operating modes

Automatic mode (12 lead data), Manual (real-time data), Arrhythmia (continuous monitoring)

Digital sampling

>1000 samples/second/channel

Lead printout sequence

Standard (Einthoven), Cabrera

ECG analysis frequency

500 samples/second/channel

Report formats

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

Dynamic range

AC differential +/-5 mV, DC offset (Polarization voltage) +/300 mV

Heart rate meter

30 to 300 BPM ±2% or ±1 BPM, whichever is greater. Heart rates outside this range do not display.

Resolution

5 μV

Baseline adjustment

Automatic adjustment of the baseline to the optimal recording range.

Frequencyresponse

0.01to150Hz

Low cut-off frequency

0.01 Hz, 0.04 Hz, 0.08 Hz or 0.16 Hz (-3-dB limits), equivalent to a time constant of 16s, 4s, 2s, or 1s

A-2

Anti-driftsystem(ADS)

MAC™ 400

Lead-fail indication

Automaticcompensationof baseline Audible and visual indication of disconnected electrodes or line break; each single electrode is monitored except N/right leg

2036039-001D


Software options

Marquette 12SL ECG-based measurement package gives QRS, QT/QTC, PR, P, RR/PP, and P/QRS/T

Papersize

Width80mm Z-fold length 90 mm, 280 sheets/ pack

Marquette 12SL ECG-based analysis package for analysis and interpretation Display

Roll paper length 15.7 m Writer speeds accuracy

Typical +/- 1 Maximum +/- 5%

Type

LCD,2rowx16character alphanumeric with adjustable contrast

Writer amplitude accuracy

Displayed data

Selected lead group, operation mode, lead check, heart rate, AC filter, muscle filter, gain (sensitivity), speed

Keyboard

Writer

Type

+/- 5%

Membranekeyboardwithtactile feedback

Writer technology

Thermal array printhead

Power supply

Resolution

Vertical 8 dots/mm

Ratings

100to240V+/-10%

Number of traces

3 in automatic and arrhythmia modes

Frequency

50/60Hz+/-10%

Batterytype

Lithiumion,7.2V

Horizontally 40 dots/mm at 25 mm/s

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 5mm/s is not available in auto mode

Writer sensitivity (gain) Papertype

5,10,20mm/mV Z-fold,roll

Battery c apacity

100“automatic” ECG recordings or operating time recording of 4 hours without recording

Physical specifications

Batterycharging

263 mm

Height

78 mm

Depth

208mm

Approximately3hours Automaticbatterychargingvia built-in charger during line-power operation

Relative humidity

Transport/storage

Width

2036039-001D

Batterychargetime

Operating

25-95% 25-95%

Pressure Transport/storage

MAC™ 400

500to1060hPa

A-3


Weight

1.3kg/2.86lb.withbattery

Operating

700to1060hPa

Environmental specifications Temperature (with battery) Transport/storage

-15° C to + 50° C

Operating

+10° C to 40° C

Certifications: 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

Electrom agnetic comp atibility (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.

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.

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 Emissionstest RF emissions

Compliance 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 domestic purposes.

EN 55011 RF emissions EN 55011 Harmonic Emissions

Electromagneticenvironment-guidance

Class A

EN 61000-3-2 Voltage fluctuations/Flicker emissions

Complies

EN 61000-3-3

B-2

MAC™ 400

2036039-001D


Guidance and manufacturer’s declarationelectromagnetic immunity Immunity test Electrostatic discharge (ESD)

EN60601 test level

Compliance level

Electromagnetic environment-guidance

± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

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

Electrical fast Transient/ burst

± 2 kV for power supply lines

± 2 kV for power supply lines

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

EN 61000-4-4

±1 kV for input/output lines

±1 kV for input/output lines

Surge

± 1 kV differential mode

± 1 kV differential mode

EN 61000-4-5

± 2 kV common mode

± 2 kV common mode

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

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

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

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




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

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

for 5 sec 3 A/m

for 5 sec 3 A/m

EN 61000-4-2

EN 61000-4-11

Power frequency(50/60 Hz) magnetic field EN 61000-4-8

2036039-001D

MAC™ 400

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.

Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

B-3


Immunity test

EN60601 test level

Compliance level

Electromagnetic environment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the MAC 400, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

EN 61000-4-6

150 KHz to 80 MHz

d = 1.2

P

d = 1.2

P

80 MHz to 800 MHz d = 2.3

P

800 MHz to 2.5 GHz

Radiated RF

3V/m

EN 61000-4-3

80 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:

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

B-4

Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

MAC™ 400

2036039-001D


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

150KHz to 80MHz outside ISM bands

150KHz to 80MHz outside ISM bands

d = 1.2 P

d = 1.2 P

0.01

0.12

0.1 1

80MHz to 800MHz

800MHz to 2.5GHz

d = 1.2 P

d = 2.3 P

0.12

0.12

0.23

0.38

0.38

0.38

0.73

1.2

1.2

1.2

2.3

10

3.8

3.8

3.8

7.3

100

12

12

12

23

At 80MHz and 800MHz the separation distance of high frequency range applies. For transmitters rated at a maximum output power not listed above, the recommended separation distance [d] in meters (m) can be estimated 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.

2036039-001D

MAC™ 400

B-5


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

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

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

RTC battery 1613 thermal printer

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

2036039-001D

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

MAC™ 400

Index-1

Index

Index-2

MAC™ 400

2036039-001D

Asia Headquarters GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel: + 1 414 355 5000

1 800 558 7044 (US Only) Fax: + 1 414 355 3790

www.gehealthcare.com

GE Medical Systems Information Technologies GmbH Munzinger Straße 3-5 D-79111 Freiburg Germany Tel: + 49 761 45 43 - 0 Fax: + 49 761 45 43 - 233

GE Medical Systems Information Technologies Asia; GE (China) Co., Ltd. 11th Floor, Shanghai MAXDO Center, 8 Xing Yi Road, Hong Qiao Development Zone Shanghai 200336, People’s Republic of China Tel: + 86 21 5257 4650 Fax: + 86 21 5208 2008

GE Mac 400 Servicio

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