MAC 5500 and 5500 HD Service Manual Sw Ver 10 Rev D Aug 2013

Publication Information The information in this manual only applies to MAC® 5500 and MAC® 5500 HD system software version 10. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. MAC, MULTI-LINK, MUSE, MACTRODE, Ultra-Archivist, MobileLink, and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other marks are the properties of their respective owners. This product complies with the regulatory requirements concerning medical devices from the following bodies:

The document part number and revision are on each page of the document. The revision identifies the document’s update level. The revision history of this document is summarized in the following table. Revision

Date

Description

A

31 January 2011

Initial release.

B

14 August 2012

Updated the following sections:

• Safety Messages • Related Documentation • Parts List Removed Parts and Accessories. Refer to the operator manual for supplies and accessories information. C

3 May 2013

Updated to address the following new components: PCB (801212–008), display assembly (2026799–002), and communications board (2022332–004).

D

18 August 2013

Corrected display part numbers in Appendix B, “Software/Hardware Compatibility”, per SPR HCSDM00225973.

To access other GE Healthcare Diagnostic Cardiology manuals, go to the Common Documentation Library (CDL), located at www.gehealthcare.com/documents, and click Cardiology.

Service Manual Language Information WARNING

This service manual is available in English only.

(EN)

• If a customer's service provider requires a language other than English, it is the customer's responsibility to provide translation services.

• Do not attempt to service the equipment unless this service manual has been consulted and is understood.

• Failure to heed this warning may result in injury to the service provider, operator, or patient, from electric shock, mechanical or other hazards. ПРЕДУПРЕЖДЕНИЕ

Това упътване за работа е налично само на английски език.

(BG)

• Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е да осигури превод.

• Не използвайте оборудването, преди да сте се консултирали и разбрали упътването за работа.

• Неспазването на това предупреждение може да доведе до нараняване на доставчика на услугата, оператора или пациент в резултат на токов удар или механична или друга опасност.

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Contents

1

Introduction Product Information... 15 Indications for Use... 15 Prescription Device Statement... 15 Installation and Connection... 15 Equipment Symbols... 16 Product and Packaging Labeling... 18 Equipment Identification... 21

Regulatory and Safety Information... 22 Safety Conventions... 23 Safety Messages... 23 Responsibility of the Manufacturer... 26 Responsibility of the Purchaser/Customer... 27

Service Information... 27 Service Requirements... 27 Additional Assistance... 27

Manual Information ... 27 Manual Purpose... 27 Document Conventions... 27 Related Documentation... 29 Training... 29

2

System Overview Hardware Description ... 31 Front View... 31 Back View... 32 Internal View... 32 Back Panel... 33

3

Installation General Assembly ... 35 Adjusting Trolley Height... 37 Attaching the MAC Device to the MAC Series Trolley... 39 Attaching the Optional External Modem Kit... 41 Attaching the Magnetic Card Reader... 43 Attaching the Bar Code Reader... 46 Attaching the MAC Device to a Type-S Trolley... 48

MAC 5500 ST Requirements and Configuration ... 49 Blood Pressure Units... 49 Treadmills... 50 Bicycle Ergometers... 51

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Diagrams ... 53 PCB Diagrams... 54 LVDS/LED Display Assembly Diagram... 57

General Fault Isolation... 58 Power-Up Self-Test... 58 Visual Inspection... 59

Diagnostic Tests... 60 Loading System Diagnostic Tests... 61 Setting the Master Password... 61 Display Tests... 62 Speaker Test... 63 Keyboard Test... 63 Writer Tests... 64 Battery Tests... 68 Communication Tests... 70 Acquisition Module Test... 72 Analog I/O Tests... 73 Floppy Drive Tests... 74 Internal Memory Tests... 75 SD Card Tests... 75

Equipment Problems ... 76 Poor Quality ECGs... 76 ECG Data Noise... 76 Missing ACI-TIPI Report... 76 No BP from External Device... 76 Treadmill/Ergometer Does Not Move... 77

System Errors... 77 Frequently Asked Questions ... 78 Maintenance... 78 System Setup... 79 Clinical... 79 Transmission... 80

Input and Output Connectors ... 81 A Pins (J1)... 81 COM1 (COM3/4) Pins (J3)... 81 COM2 Pins (J5)... 82 Analog Pins (J6)... 82 EXT. VID. Pins (J7)... 82

CPU PCB Input/Output Signals... 83 Battery Pack/Monitor (J2)... 83 LCD Backlight (J4)... 83 Keyboard (J8)... 84 LCD (J10)... 84 Power Supply/Motor (J11)... 85 Thermal Printer (J12)... 86 Floppy Disk Drive (J13)... 87 Acquisition Module (J14)... 88

5

Maintenance Required Tools and Supplies ... 89 System Cleaning and Inspection... 90 Inspecting the MAC System... 90

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Inspecting Power Cords... 90 Cleaning and Disinfecting Exterior Surfaces... 90 Cleaning the Interior... 92 Cleaning the Thermal Printhead... 92 Cleaning, Disinfecting, and Storing ECG Cables and Leadwires... 93 Cleaning, Disinfecting, and Storing Handheld Devices... 95

Paper Maintenance ... 97 Setting the Correct Paper Size... 97 Loading the Paper... 98

Battery Maintenance ... 99 Charging the Battery... 99 Conditioning the Battery... 101 Replacing the Battery... 101

Cable Replacement ... 102 Replacing Patient Cables... 102 Replacing Leadwire Adapters... 102

Checking Electrical Safety... 103 Disassembly/Reassembly Instructions ... 103 Removing the Device from the Trolley... 103 Replacing the Power Supply... 105 Top Cover... 106 Display/Keyboard Assembly... 108 CPU Board... 118 Replacing the Printhead... 125 Replacing the COMM Board... 126 Replacing the Writer Roller/Carriage Assembly... 129 Replacing the Trolley Casters... 129 Replacing the Barcode Reader Cable... 131

Functional Checkouts... 133 Tools... 135 Visual Inspection... 135 Checkout Procedures... 135

6

Parts List Barcode Reader... 140 CAM ... 140 Circuit Board ... 141 Display ... 142 LVDS Converter PWA Kit (2073125–001)... 142 AUO-V1 LCD Harness Kit (2073088–001) ... 143 Display Plastic Cover Kit (2073124–001)... 144 Keyboard ... 145 Hardware ... 146

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Magnetic Card Reader... 146 Media ... 147 External Modem ... 147 Power ... 147 MAC Series Trolley... 148 Wireless ... 149 Writer... 150

A

Technical Specifications Display ... 151 Computerized Eletrocardiograph... 151 Writer... 152 Keyboard ... 152 Electrical ... 152 Vectorcardiography ... 153 Hi-Res and PHi-Res Signal-Averaged Electrocardiography ... 153 Physical (without Trolley) ... 154 Environmental... 154 Safety ... 155

B

Software/Hardware Compatibility Display Compatibility ... 157 Circuit Board Compatibility Matrix... 158 Supported Software Update Paths... 159 Software Compatibility with the -008 CPU ... 159

C

Electromagnetic Compatibility Guidance and Manufacturer's Declaration - Electromagnetic Emissions ... 161 Guidance and Manufacturer's Declaration - Electromagnetic Immunity... 162

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Guidance and Manufacturer's Declaration - Electromagnetic Immunity... 162 Recommended Separation Distances ... 164 Compliant Cables and Accessories ... 165

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Introduction

This chapter provides general information required for the proper care of the product and use of the manual. Familiarize yourself with this information before using or servicing the product.

Product Information This section provides a general overview of the product. A detailed description of the product can be found in Chapter 2, System Overview.

Indications for Use The MAC 5500/5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG’s, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Prescription Device Statement CAUTION: United States federal law restricts this device to sale by or on the order of a physician.

Installation and Connection If the installation of this equipment, in the USA, will use 240 V rather than 120 V, the source must be a center-tapped, 240 V, single-phase circuit. Contact GE Healthcare for information before connecting any devices to this equipment not recommended in this manual.

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Equipment Symbols The following symbols may appear on the product or its packaging. Symbol

Description Type BF equipment. The acquisition module is protected from defibrillation shocks. Alternating Current Equipotential

Charge the battery. The flashing amber LED next to this symbol indicates you must connect the system to AC power to recharge the battery. LAN port for connecting an Ethernet cable with a standard RJ-45 jack.

Internal modem port for connecting a phone line with a standard RJ-11 jack. Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

Recycle the battery. Consult the accompanying documentation.

Classified with respect to electric shock, fire, mechanical, and other specified hazards only in accordance with applicable UL standards.

To reduce the risk of electric shock, do NOT remove cover (or back). Refer servicing to qualified personnel. This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.) Manufacturer name and address.

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Symbol

Description Authorized European representative. PCT. GOST marking symbolizing conformity with applicable Russian Gosstandart technical and safety standards. USA Only: For use only on or by order of a physician.

CE Mark - Symbolizes conformity with applicable EU (European Union) directives.

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Introduction

Product and Packaging Labeling This section identifies the product labels and their locations on the product and packaging.

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Introduction

Refer to the previous illustrations for the locations of the labels identified in the following table.

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No. Label

Description

1

Located on the bottom of the device, this label indicates the device contains mercury and must be disposed of in accordance with state and local laws.

2

Located on the cover of the device, this label identifies the product's model number.

3

Located on the back of the device, this label contains the Disposal and GOST labels. Refer to “Equipment Symbols” on page 16 for detailed descriptions of the symbols.

4

Located inside the writer compartment, this label uniquely identifies this unit. Refer to “Product Label” on page 21 for detailed information.

5

Located on the back of the device, this label provides regulatory and cautionary information. Refer to “Equipment Symbols” on page 16 for detailed descriptions of the symbols.

6

Located on the back of the device, this label identifies the device's electrical ratings.

7

Located inside the battery compartment, this label provides information about the specifications and disposal of the battery. Refer to “Equipment Symbols” on page 16 for detailed descriptions of the symbols.

8

Located on the front of the device, this label indicates that, in the USA, federal law restricts sale of the device to or on the order of a physician.

9

Located below the display, this label indicates the device uses the Marquette™ 12SL™ ECG Analysis Program to analyze and interpret ECG readings.

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Introduction

10

Located to the right of the display, this label instructs the user on where to place leads.

11

Located on the right side of the device, this label distinguishes between the LAN RJ-45 port and the internal modem RJ-11 port.

12

Located on the package, the shipping label contains the following information: • Product description • Sales order number • Configuration number • Model number • Serial number • Storage conditions • Regulatory compliance • Country of Origin • EC Representative information

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Equipment Identification Every GE Healthcare device has a product label that identifies the product name, part number, manufacturing information, and unique serial number. This information is required when contacting GE Healthcare for support.

Product Label The product label is laid out in the following format. Depending on the product, the label may vary slightly in format, but it contains the same information.

Product Label Format Item

Description

1

Product part number

2

Product description

3

Date of manufacture in YYYY-MM format

4

Manufacturer name and address

5

Country of origin

6

Product bar code

7

Unit serial number (See “Serial Number Format” on page 21 for more information.)

Serial Number Format Each device has a serial number that uniquely identifies the device and provides important information about the device. The serial number format is shown in the following illustration:

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Introduction

Serial Number Format Item

Name

Description

1

Product Code

A three-letter code that uniquely identifies the product line. Refer to “Product Codes” on page 22 for more information.

2

Year Manufactured

A two-digit code identifying the year the device was manufactured. Values range from 00 to 99. For example: 00 = 2000, 04 = 2004, 05 = 2005 (and so on).

3

Fiscal Week Manufactured

A two-digit code identifying the week the device was manufactured. Values range from 01 to 52. GE Healthcare's fiscal weeks correspond to the calendar week. For example, 01 = the first week in January.

4

Product Sequence

A four-digit number identifying the order in which this device was manufactured. Values range from 000 to 9999.

5

Manufacturing Site

A one-letter code identifying the site where the device was manufactured. For example, F = Milwaukee, N = Freiburg, P = Bangalore

6

Miscellaneous Characteristic

For example, P = the device is a prototype, R = the device was refurbished, U = the device was upgraded to meet the specifications of another product code.

Product Codes The product code identifies specific system platforms. You need the product code before servicing or requesting support for your device. You can identify the product code using the device’s serial number, which can be located in one of the following places: • On the product label attached to the base of the device. • On the product label provided with the application CD. • In the application on IT systems: Launch the system application and click Help > About to view the serial number. For information on launching the application, refer to the product's service or operator's manual.

Regulatory and Safety Information This section provides information about the safe use and regulatory compliance of this device. Familiarize yourself with this information and read and understand all instructions before attempting to service this device. NOTE: Disregarding the safety information provided is considered abnormal use of this device and could result in injury, loss of data, and void any existing product warranties. 22

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Safety Conventions A Hazard is a source of potential injury to a person, property, or the system. This manual uses the terms DANGER, WARNING, CAUTION, and NOTICE to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with the following definitions and their significance. Definitions of Safety Conventions Safety Convention

Definition

DANGER

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

WARNING

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

CAUTION

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

NOTICE

Indicates a potential hazard or unsafe practice, which, if not avoided, could result in the loss or destruction of property or data.

Safety Messages The following messages apply to the system as a whole. Specific messages may also be provided elsewhere in the manual. WARNING: PATIENT MONITORING - This device does not provide alarms and is not intended to be used as electrocardiographic monitoring equipment (vital signs physiological monitor). If patient monitoring is required, use a device that has been qualified for that use. WARNING: ACCIDENTAL SPILLS - If liquids enter a device, take the device out of service and have it checked by a service technician before it is used again. To avoid electric shock or device malfunction, liquids must not be allowed to enter the device. WARNING: BATTERY OPERATION - If the integrity of the protective earth conductor is in doubt, operate the unit from its battery. WARNING: CABLES - To avoid possible strangulation, route all cables away from the patient's throat. WARNING: CONNECTION TO MAINS - This is class I equipment. The mains plug must be connected to an appropriate power supply.

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WARNING: DEFIBRILLATOR PRECAUTIONS - Do not come into contact with patients during defibrillation. Otherwise, serious injury or death could result. Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillation protection, use only the recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation. WARNING: ELECTRODES - Polarizing electrods (stainless steel or silver constructed) may cause the electrodes to retain a residual charge after defibrillation. A residual charge will block acquisition of the ECG signal. Whenever patient defibrillation is a possibility, use non-polarizing electrodes (silver or silver chloride construction) for ECG monitoring. WARNING: MAGNETIC AND ELECTRICAL INTERFERENCE - Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason, make sure that all external devices operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment or MRI devices are possible sources of interference as they may emit higher levels of electromagnetic radiation. WARNING: EXPLOSION HAZARD - Do NOT use in the presence of flammable anesthetics vapors or liquids. WARNING: INTERPRETATION HAZARD - Computerized interpretation is only significant when used in conjunction with clinical findings. A qualified physician must overread all computer-generated tracings. WARNING: OPERATOR - Medical technical equipment such as this system must be used only by qualified and trained personnel. WARNING: SHOCK HAZARD - Improper use of this device presents a shock hazard. Strictly observe the following guidelines. Failure to do so may endanger the lives of the patient, user, and bystanders. When disconnecting the device from the power line, remove the plug from the wall outlet before disconnecting the cable from the device; otherwise, there is a risk of coming into contact with line voltage by inadvertently introducing metal parts in the sockets of the power cord. Devices may be connected to other devices or to parts of systems only after making certain that there is no danger to the patient, operators, or environment as a result. Standards IEC 60601–1–1/EN60601–1–1 must be complied with in all cases.

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WARNING: SITE REQUIREMENTS - Improper placement of the device and/or accessories may result in a hazard to the patient, operator, or bystanders. Do not route cables in a way that they may present a stumbling hazard. Connectors for patient cables and leadwires are designed to prevent accidental disconnection. For devices installed above the patient, adequate precautions must be taken to prevent them from dropping on the patient. WARNING: TREADMILLS - Avoid rapid changes in treadmill speed and/or grade during a stress test. CAUTION: PROPER LEADWIRE CONNECTION - Improper connection will cause inaccuracies in the ECG. Trace each individual leadwire from its acquisition module label to the colored connector and then to the proper electrode to ensure that it is matched to the correct label location. CAUTION: ACCESSORIES (SUPPLIES) - Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards, and/or the system configuration must meet the requirements of the IEC 60601–1–1 medical electrical systems standards. To ensure patient safety, use only parts and accessories manufactured or recommended by GE Healthcare. CAUTION: ACCESSORIES (EQUIPMENT) - The use of accessory equipment that does not comply with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice of equipment shall include: • Use of the accessory in the patient vicinity, and • Evidence that the safety certification of the accessory has been performed in accordance with the appropriate IEC 60601–1 and/or IEC 60601–1–1 harmonized national standard. CAUTION: BATTERY POWER - If a device equipped with an optional battery pack will not be used or connected to the power line for a period of over six months, remove the battery. CAUTION: BEFORE INSTALLATION - Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility. CAUTION: DISPOSABLES - Disposable devices are intended for single use only. They should not be reused as performance may degrade or contamination could occur. 2046275-017D

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CAUTION: DISPOSAL - At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with local, state, or federal guidelines regulating the disposal of such products. If you have questions concerning the disposal of the product, please contact GE Healthcare or its representative. CAUTION: EQUIPMENT DAMAGE - Devices intended for emergency application must not be exposed to low temperatures during storage and transport to avoid moisture condensation at the application site. Wait until all moisture has vaporized before using the device. CAUTION: ELECTRIC SHOCK - To reduce the risk of electric shock, do not remove cover or back. Refer servicing to qualified personnel. CAUTION: OPERATOR - Medical technical equipment such as this electrocardiograph system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly. CAUTION: POWER REQUIREMENTS - Before connecting the device to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit's label. If this is not the case, do not connect the system to the power line until you adjust the unit to match the power source. In the USA, if the installation of this equipment will use 240V instead of 120V, the source must be center-tapped, 240V single-phase circuit. This equipment is suitable for connection to public mains as defined in CISPR 11. CAUTION: SERVICEABLE PARTS - This equipment contains no user serviceable parts. Refer servicing to qualified service personnel. CAUTION: SUPERVISED USE - This equipment is intended for use under the direct supervision of a licensed health care practioner.

Responsibility of the Manufacturer GE Healthcare is responsible for the safety, reliability, and performance of hardware supplied by GE Healthcare only if the following conditions are met: • Assembly operations, extensions, readjustments, modifications, or repairs are performed by persons authorized by GE Healthcare. • The electrical installation of the room where the device is used complies with the requirements of the appropriate local, state, and other government regulations. • The equipment is used in accordance with the instructions for use.

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