MAC 1600 Operators Manual sw ver 1.0 Rev B

NOTE This manual applies MAC™ 1600 software version 1.0. This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

Archivist, CardioSoft, CASE, Hookup Advisor, MAC, Mactrode, Multi-Link, MUSE, SilverTRACE, and 12SL are trademarks owned by General Electric Company. All other marks are not owned by GE and are instead owned by their respective owners. ©2008 General Electric Company. All rights reserved.

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Contents 1

Introduction Manual Information... 1-2 Purpose...1-2 Intended Audience...1-2 Revision History...1-2 Conventions...1-2 Product References...1-3 Illustrations and Names...1-3 Safety Information... 1-3 Safety Messages... 1-3 Classification...1-9 Underwriters Laboratories, Inc...1-9 Biocompatibility...1-10 Legal Notice...1-10 Responsibility of the Manufacturer...1-10 General Information... 1-10 Indications of Use...1-10 Contraindications...1-11 Recording ECGs During Defibrillation...1-11 Accuracy Of the Input Signal Reproduction...1-12 Modulating Effects in Digital Systems...1-12 Installation and Connection...1-12 Parts and Accessories...1-12 Equipment Symbols...1-13 Service Information... 1-15 Service Requirements...1-15 Equipment Identification...1-15

2

Equipment Overview Equipment Description... 2-2 Front View...2-2 Side View...2-3 Back View...2-3 Keyboard Layout...2-4 Acquisition Modules...2-6 Leadwire Adapters...2-7 Setting Up the Equipment... 2-7 Inserting the Battery...2-8 Connecting the AC Power Adapter...2-8 Connecting Leadwires...2-9

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Inserting Paper...2-9 Connecting the Barcode Reader...2-10 Connecting the Optional Internal Modem...2-10 Connecting to an External Modem...2-10 Connecting to a LAN...2-10 Connecting External Devices (Stress Option)...2-10 Turning on the System...2-11 Configuring the Device...2-11 Testing the Device...2-11 System Description... 2-12 Start Up Screen...2-12 Using the MAC 1600 Keyboard... 2-12

3

Preparing the Patient Prepare the Patient’s Skin... 3-2 Applying the Electrodes... 3-3 Resting ECG Electrodes...3-4 Stress ECG Electrodes...3-6

4

Entering Patient Information Entering Patient Information Manually... 4-2 Entering Patient Information with a Barcode Reader... 4-3

5

Recording a Resting ECG Introduction... 5-2 Resting ECGs... 5-3 Recording a Resting ECG...5-3 ECG Options...5-4 Post-Acquisition Options...5-6 Generating a Rhythm Report (Manual Recording)... 5-7 ECG Reanalysis... 5-8 Reanalyzing an ECG...5-8 Reanalysis Layout...5-9 Reanalysis Options...5-10 Hookup Advisor Module... 5-12 Special Considerations... 5-12 Recording ECGs of Pacemaker Patients...5-13 Recording ECGs during Defibrillation...5-13

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Arrhythmia Mode Recording Introduction... 6-2 Arrhythmia Mode... 6-2 Printing an Arrhythmia Report...6-2 Arrhythmia Options...6-3 Printing Options...6-5 Arrhythmia Codes... 6-5

7

Stress Testing Introduction... 7-2 Stress Mode Interface... 7-3 Stress Test Information Bar...7-3 Stress Test Keys...7-5 Stress Options...7-6 Conducting Stress Tests... 7-8 Conducting a Stress Test with a Treadmill or Ergometer...7-8 Conducting a Stress Test with a Master’s Step Device...7-11

8

Managing Internal Storage Introduction... 8-2 Importing Records... 8-3 Printing the File Manager Directory... 8-4 Finding Records... 8-4 Editing Patient Data... 8-5 Deleting Records... 8-6 Printing Records... 8-7 Transmitting Records... 8-7 Exporting Records... 8-8

9

System Configuration Introduction... 9-2 Setup Functions... 9-2

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Basic Setup...9-2 Resting ECG Setup...9-6 Arrhythmia Setup...9-12 Stress ECG Setup... 9-13 Communication Setup...9-19 Country Setup...9-23 Patient Setup...9-24 User Setup...9-27 Options Setup...9-29 Service Setup...9-30 Date/Time Setup...9-31 Setup Utilities... 9-31 Print Setup Report...9-31 Select Setup...9-32 Export Setup...9-33 Import Setup...9-34 Exporting Audit Trail...9-34

10

Maintenance Introduction... 10-2 MAC 1600 Maintenance... 10-2 Inspecting the Equipment...10-3 Cleaning the Device... 10-3 Cable and Leadwire Maintenance... 10-4 Sanitizing Cables and Leadwires... 10-4 Storing Cables and Leadwires...10-7 Replacing Leadwire Adapters...10-7 Paper Maintenance... 10-8 Replacing Paper...10-8 Adjusting the Paper Tray for Paper Size...10-9 Storing Thermal Paper...10-10 Battery Maintenance... 10-11 Battery Safety...10-12 Replacing the Battery...10-12 Conditioning the MAC 1600 Battery Pack...10-13 Supplies and Accessories... 10-14

A

Troubleshooting General Troubleshooting Tips... A-2 Equipment Problems... A-2 System Will Not Power Up... A-3

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ECG Data Contains Noise... A-3 ACI-TIPI Statement is Not Included on Report... A-4 No BP Readings from Ergoline 900 Ergometer... A-4 External Device Does Not Move... A-4 Paper Jams... A-5 SD Card Not Present... A-5 Cannot Import or Transmit Records Via Modem... A-6 Cannot Export to Shared Directories... A-6 System Errors... A-7

B

Creating Barcodes Introduction... B-2 Setting up the Patient Data Scheme... B-2 Configuring the Barcode Reader... B-3 Configuring the Barcode Reader Manually... B-3 Configuring the Barcode Reader Automatically... B-4

Index

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Introduction

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Introduction

Manual Information Purpose This manual describes the safe and effective operation of the MAC™ 1600 .

Intended Audience This manual is written for clinical professionals who use, maintain, and/ or troubleshoot the MAC™ 1600 . Clinical professionals are expected to have a working knowledge of appropriate medical procedures, practices, and terminology used in the treatment of patients.

Revision History The document part number and revision appear at the bottom of each page. The revision identifies the document’s update level.

Revision History, PN 2028451-182 Revision

Date

A

29 February 2008

B

25 April 2008

Comment Initial release of document. Corrected the duration of the battery’s normal operation from 4 hours to 3.

Conventions The following conventions are used throughout this manual. Bold

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

Italics

Indicates software terms that identify menu items, buttons, or options in various windows.

Ctrl + Esc

Indicates a keyboard operation. A (+) sign between the names of two keys indicates that you must press and hold the first key while pressing the second key once. For example, “Press Ctrl + Esc” means to press and hold down the Ctrl key while pressing the Esc key.

Enter

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Indicates you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.

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Product References The name of the product described in this manual is MAC 1600 ECG Analysis System. It will be referred to as “the system” or “the device” throughout this document.

Illustrations and Names All illustrations in this manual are provided as examples only. They may not necessarily reflect your system’s setup or the data on your system. In this manual, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental.

Safety Information Safety Messages The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness.

Definitions Familiarize yourself with the safety message definitions and significance. Hazard is defined as a source of potential injury to a person. 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 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.

Applicable Messages The following safety information applies to the MAC 1600 ECG Analysis System.

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WARNING ACCIDENTAL SPILLS - If liquids have entered a device, take it 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 patient's throat.

WARNING CONNECTION TO MAINS - This is Class I equipment. The mains plug must be connected to an appropriately grounded power supply.

WARNING RF INTERFERENCE - Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause unexpected or adverse operation of this device Consult qualified personnel regarding system installation.

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 defibrillator protection, use only the recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation.

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WARNING ELECTRODES - Polarizing electrodes (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 nonpolarizing (silver/silver chloride construction) electrodes 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 computergenerated tracings.

WARNING OPERATOR - Medical technical equipment such as this system must only be used by qualified and trained personnel.

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WARNING SHOCK HAZARD - Improper use of this device presents a shock hazard. Strictly observe the following warnings. Failure to do so may endanger the lives of the patient, the user, and bystanders. When disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device. Otherwise there is a risk of coming in 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, the operators, or the environment as a result. Standards IEC 60601-1-1/EN60601-1-1 must be complied with in all cases.

WARNING SITE REQUIREMENTS - Do not route cables in a way that they may present a stumbling hazard. For safety reasons, all connectors for patient cables and leadwires are designed to prevent inadvertent disconnection, should someone pull on them. 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 ACCESSORIES (SUPPLIES) - 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, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard.

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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 (EQUIPMENT) - The use of ACCESSORY equipment not complying 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 shall include: Use of the accessory in the PATIENT VICINITY; and Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.

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.

CAUTION PRODUCT 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 disposal of the product, please contact GE or its representatives.

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Introduction

WARNING PACKAGING DISPOSAL - Dispose of all packaging material, observing all applicable waste control regulations and keeping out of children’s reach.

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.

WARNING 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 U.S.A., if the installation of this equipment will use 240V rather than 120V, the source must be a centertapped, 240V, single-phase circuit. This equipment is suitable for connection to public mains as defined in CISPR 11.

CAUTION RESTRICTED SALE - U.S. federal law restricts this device to sale by or on the order of a physician.

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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 practitioner.

CAUTION EQUIPMENT CONFIGURATION - The equipment or system should not be used adjacent to, or stacked with other equipment. If adjacent or stacked use is necessary, test the equipment or system to verify normal operation.

Classification The unit is classified, according to IEC 60601-1, as: Type of protection against electrical shock

Class I internally powered equipment

Degree of protection against electrical shock

Type BF defibrillation-proof applied part

Degree of protection against harmful ingress of water

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

Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Method(s) of sterilization or disinfection recommended by the manufacturer

Not applicable

Mode of operation

Continuous operation

Underwriters Laboratories, Inc. Medical Equipment With respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, IEC 60601-2-25, and CAN/CSA C22.2 NO. 601.1.

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Introduction

Biocompatibility The parts of the product described in this operator’s manual, including all accessories, that come in contact with the patient during the intended use, fulfill the biocompatibility requirements of the applicable standards. If you have questions in this matter, please contact GE or its representatives.

Legal Notice Our equipment contains several fields which can be filled in before performing an ECG. While some of these fields are required, some are optional and left to the user to assess whether they are needed to perform the exam. A field RACE is one of these optional fields. It has been acknowledged by the medical profession as useful to analyze some pathologies. You should be aware that, in some jurisdictions, the processing of data revealing an individual’s racial origin is subject to legal requirements, such as obtaining the patient’s prior consent. If you elect to collect this type of data, it is your responsibility to ensure that you comply with all applicable legal requirements.

Responsibility of the Manufacturer 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 Information Indications of Use The MAC 1600 ECG Analysis System is a portable ECG acquisition, analysis, and recording system. It is intended:

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to acquire, analyze, display, and record information from adult and pediatric populations,

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to be used under the direct supervision of a licensed health care practitioner,

„

to be used by trained operators in a hospital or medical professional’s facility environment to record ECG signals from surface electrodes,

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to offer two basic modes of operation: (1) resting ECG mode and (2) arrhythmia mode

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to print 6 or 12 leads of ECGs,

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to be upgradable to provide software options such as 12-lead ECG measurement and interpretive analysis,

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to be upgradable with a third mode of operation: (3) Exercise mode for exercise stress testing, and

„

to provide for the optional transmission and reception of ECG data to and from a central ECG cardiovascular information system.

NOTE Pediatric population is defined as patients between the ages of 0 and 15 years of age. Arrhythmia detection is provided for the convenience or automatic documentation.

Contraindications The MAC 1600 device is NOT intended: „

to be used during patient transport,

„

to be used for intra-cardiac applications,

„

to be used as a vital signs physiological monitor, or

„

to provide alarms for Arrhythmia detection. The Arrhythmia detection mode is provided for the convenience of automatic documentation.

Recording ECGs During Defibrillation It is not necessary to remove the ECG electrodes prior to defibrillation; the patient signal is defibrillation-proof. Use silver-silver chloride electrodes. A defibrillator discharge may cause stainless steel or silver electrodes to retain a residual charge, which could cause a polarization that will block the acquisition of the ECG signal for several minutes. We recommend using non-polarizing disposable electrodes with defibrillation recovery ratings as specified in AAMI EC 12.3.2.2.4 (SilverTRACE family of electrodes). AAMI EC12 requires that the polarization potential of an electrode pair does not exceed 100 mV 5 seconds after a defibrillation discharge. If other electrodes are used, disconnect the patient cable from the system before delivering the defibrillation shock. NOTE If excessive DC voltages are present at the electrode, then a message will appear indicating a Lead Off condition. ADS (cubic spline correction) and the FRF algorithm cause a signal delay of approximately 2 seconds; therefore they should be disabled if the patient has to be defibrillated while the ECG is being recorded.

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Introduction

Accuracy Of the Input Signal Reproduction „

Overall System Error is tested using the method described in AAMI EC11 3.2.7.1. Overall System Error is +5%.

„

Frequency Response is tested using the method described in AAMI EC11 3.2.7.2 methods A and D.

Modulating Effects in Digital Systems This device uses digital sampling techniques that may produce some variation in amplitudes of Q, R, and/or S waves from one heart beat to the next, which may be particularly noticeable in pediatric recordings. If this phenomenon is observed, the clinician should be aware that the origin of amplitude variations is not entirely physiologic. For measuring voltages of Q, R, and S waves, it is advisable to use the QRS complexes with the largest deflection of the particular waves.

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 for information before connecting any devices to this equipment not recommended in this manual.

Parts and Accessories To ensure patient safety, use only parts and accessories manufactured or recommended by GE. Browse to www.gehealthcare.com to obtain information about GE-recommended supplies and accessories. Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. The use of ACCESSORY equipment not complying 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 shall include:

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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 and/or IEC 60601-1-1 harmonized national standard.

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Equipment Symbols The following symbols may appear on the product, its packaging, and or its documentation. Defibrillation-proof type BF equipment.

Equipotential ground point

Protective earth terminal Indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. Attention, see instructions for use

Consult instructions for use.

Catalogue (part) number.

Serial number.

For use by or on the order of a physician or persons licensed by state law. (US Only) Date of manufacture.

Manufacturer address.

Environment-friendly Use Period per Chinese standard SJ/T11363-2006 (China specific). This way up

Recyclable.

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