GE Medical Systems Information Technologies MAC7 MAC 7 User Manual MAC 7 Resting ECG Analysis System

GE Medical Systems Information Technologies Inc. MAC 7 MAC 7 Resting ECG Analysis System

User Manual

GE HealthcareMAC™ 7 Resting ECG Analysis SystemVersion 1.00Regulatory and Safety Manual2109599-003 AMAC™ 7 Resting ECG Analysis SystemVersion 1.00English© 2018 General Electric CompanyAll Rights Reserved.
Publication InformationThis document describes version 1.00 of MAC™ 7 Resting ECG Analysis System, also referred to as the “product” or "system" or "device".It does not apply to earlier product versions. Due to continuing product innovation, specifications in this document are subject to changewithout notice.MUSE, MAC, MARS, CASE, CardioSoft, and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a GeneralElectric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners.The MAC ™7 Resting ECG Analysis System is intended to be used, under the direct supervision of a licensed healthcare practitioner bytrained operators in a hospital or facility providing patient care.This document provides information required for the proper use of the system. Familiarize yourself with this information and read andunderstand all instructions before attempting to use this system.NOTE:Illustrations in this document are provided as examples only. Depending on system configuration, screens in the document may differfrom the screens on your system. Patient names and data are fictitious. Any similarity to actual persons is coincidental.The document part number and revision are on each page of the document. The revision identifies the document’s update level. Therevision history of this document is summarized in the following table.Revision Date CommentA 15 August 2018 Initial ReleaseTo access other GE Healthcare Diagnostic Cardiology documents, go to the Common Documentation Library (CDL), located at http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library, and click Cardiology.To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website.SupportGE Healthcare maintains a trained staff of application and technical experts to answer questions and to respond to issues and problemsthat may arise during the installation, maintenance, and use of this product.If you require additional assistance, contact your GE Healthcare representative or GE Healthcare support at one of the following numbers:• North America: 1-800-558-7044• Europe: +49 761 45 43 -0• Asia: +86 21 3877 7888TrainingThis document is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the useof the product, you should request training assistance from GE Healthcare.To see available training, go to the GE Healthcare training website (www.gehealthcare.com/training). Select Education> ProductEducation-Technical> Diagnostic Cardiology. For more self-paced course offerings, tools, and reference guides you may find useful,please visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.2 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Table of ContentsPublication Information....................................................................... 21:Regulatory Information.......................................................................................4Intended Use............................................................................................................................................................4Indications for Use................................................................................................................................................4Contraindications...................................................................................................................................................5Prescription Device Statement........................................................................................................................5Classification of Medical Device.....................................................................................................................5Recording ECGs during Defibrillation........................................................................................................... 5Modulating Effects in Digital Systems......................................................................................................... 6Biocompatibility.......................................................................................................................................................6Legal Notice..............................................................................................................................................................6Responsibility of the Manufacturer...............................................................................................................7Responsibility of the Purchaser/Customer................................................................................................ 7Warranty Information..........................................................................................................................................72:Safety Information............................................................................................... 8Safety Conventions............................................................................................................................................... 8Safety Hazards........................................................................................................................................................8Supplies and Accessories................................................................................................................................123:Product and Packaging Information...............................................................13Hardware Label Locations..............................................................................................................................134:Equipment Identification...................................................................................17Serial Number Label.......................................................................................................................................... 17Device Address Label and Rating Plate................................................................................................... 17Symbol Descriptions.......................................................................................................................................... 18Serial Number Format...................................................................................................................................... 22Unique Device Identifier...................................................................................................................................225:Electromagnetic Compatibility (EMC)............................................................. 23Guidance and Manufacturer’s Declaration—Electromagnetic Emissions................................24Guidance and Manufacturer’s Declaration—Electromagnetic Immunity.................................24Recommended Separation Distances.......................................................................................................276:Wireless Regulations......................................................................................... 29FCC Compliance...................................................................................................................................................29IC Compliance.......................................................................................................................................................30RED Information...................................................................................................................................................31
Regulatory Information1Regulatory InformationFamiliarize yourself with this information before attempting to use this system.Keep this manual with your Operator Manual and equipment at all times, andperiodically review it.This section provides information about the regulatory compliance of this system.The system software is considered medical software. As such, it was designed andmanufactured to the appropriate medical regulations and controls.Intended UseThe system is intended to acquire, analyze, display, and record electrocardiographicinformation from adult, pediatric or neonatal populations. Basic system delivers 3,6,or 12 lead ECG’s and interpretive analysis. Transmission and reception of ECG dataand other clinical data to and from a central clinical information system is optional.The system is intended to be used under the direct supervision of a licensedhealthcare practitioner, by trained operators in a hospital or medical professional’sfacility.Indications for UseThis device is a non-invasive prescription device.The device is indicated for use:• To acquire, analyze, display and print electrocardiograms.• To provide interpretation of the data for consideration by a physician.• In a clinical setting, by a physician or by trained personnel who are acting on theorders of a licensed physician. It is not intended as a sole means of diagnosis.The interpretations of ECG offered by the device are only significant when usedin conjunction with a physician over-read as well as consideration of all otherrelevant patient data.• On adult and pediatric (birth through 21 years of age) populations.4 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Regulatory InformationContraindicationsThis system is not intended for use in the following manner:• During patient transport• With high-frequency surgical units• As an intra-cardiac application• As a sole means of diagnosis• As a vital signs physiological monitorPrescription Device StatementCAUTION:United States federal law restricts this device to sale by or on the order of aphysician.Classification of Medical DeviceThe device is classified as follows according to IEC 60601-1.Table 1: Medical Device ClassificationsCategory ClassificationType of protection against electrical shock Class I, internally poweredDegree of protection against electrical shock Type CF defibrillation-proof applied partDegree of protection against harmful ingress ofsolids and liquidsThe Ingress Protection (IP) code for this device isIP 20.Degree of safety of application in the presenceof a flammable anesthetic mixture with air orwith oxygen or with nitrous oxideEquipment is not suitable for use in the presenceof a flammable anesthetic mixture with air orwith oxygen or with nitrous oxideMethod(s) of sterilization or disinfectionrecommended by the manufacturerNot applicableMode of operation Continuous operationRecording ECGs during DefibrillationThis equipment is protected against the effects of cardiac defibrillator dischargeto ensure recovery, as required by test standards. The patient signal input of theacquisition module is defibrillation-proof. It is not necessary to remove the ECGelectrodes prior to defibrillation.2109599-003 A MAC™ 7 Resting ECG Analysis System 5
Regulatory InformationWhen using stainless steel or silver electrodes, a defibrillator discharge current maycause the electrodes to retain a residual charge causing a polarization or DC offsetvoltage. This electrode polarization blocks acquisition of the ECG signal. To avoid thiscondition, if there is a situation where a defibrillation procedure is necessary, usenon-polarizing electrodes such as silver/silver-chloride types, which do not form a DCoffset voltage when subjected to a DC current.If you use polarizing electrodes, GE Healthcare recommends disconnecting theleadwires from the patient before delivering the shock.Electrode defibrillation recovery is the ability of the electrode to allow the ECG traceto return after defibrillation. GE Healthcare recommends using non-polarizingdisposable electrodes with defibrillation recovery rating as specified in AAMIEC12.5.2.2.4. AAMI EC12 requires that the polarization potential of an electrode pairdoes not exceed 100 mV 5 seconds after a defibrillation discharge.Refer to the supplies and accessories guide for this system for a list of approvedelectrodes.Modulating Effects in Digital SystemsThis section describes the modulating effects that may occur in digital systems of theproduct.This device uses digital sampling techniques that may produce some variation inamplitudes of Q, R, and/or S waves from one heart beat to the next, which may beparticularly noticeable in pediatric recordings. If you observe this phenomenon,be aware that the origin of amplitude variations is not entirely physiological. Formeasuring voltages of Q, R, and S waves, GE Healthcare advises using the QRScomplexes with the largest deflection of the particular waves.BiocompatibilityThe parts of the system described in this manual that come into contact with thepatient during the intended use, including all accessories, fulfill the biocompatibilityrequirements of the applicable standards. If you have questions in this matter contactyour GE Healthcare representative.Legal NoticeGE Healthcare software contains several fields that can be populated beforeperforming an ECG. Some of these fields are required, others are optional andleft to the user to assess whether they are needed to perform the exam. The fieldRace is one of these optional fields. Race has been acknowledged by the medicalprofession as useful to analyze some pathologies. You should be aware that, in somejurisdictions, the processing of data revealing an individual’s racial origin is subjectto legal requirements, such as obtaining the patient’s prior consent. If you elect to6 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Regulatory Informationcollect this type of data, it is your responsibility to ensure that you comply with allapplicable legal requirements.Responsibility of the ManufacturerThis section describes the responsibility of GE Healthcare as the manufacturer of yourproduct.GE Healthcare is responsible for the safety, reliability, and performance of hardwaresupplied by GE Healthcare only if the following conditions are met:• Assembly operations, extensions, readjustments, modifications, or repairs areperformed by persons authorized by GE Healthcare.• The electrical installation of the room where the device is used complies with therequirements of the appropriate local, state, and other government regulations.• The equipment is used in accordance with the instructions for use.Responsibility of the Purchaser/CustomerThe customer is responsible for providing appropriate desks, chairs, electrical walloutlets, network connections, and analog phone lines, and for locating any of thesystem components described in the manuals in compliance with all local, state, andnational codes.Lack of data security may compromise patient privacy. GE Healthcare recommendsthat you take appropriate steps to secure the privacy of communication on yournetwork when using this product.Warranty InformationThis device is considered GE Healthcare-supplied hardware. Only authorized GEHealthcare service personnel should service the device. Any unauthorized attempt torepair equipment under warranty voids that warranty. It is the user’s responsibility toreport the need for service to GE Healthcare or to one of their authorized agents.2109599-003 A MAC™ 7 Resting ECG Analysis System 7
Safety Information2Safety InformationSafety ConventionsThis section describes the safety conventions used in the documentation for theproduct.A Hazard is a source of potential injury to a person, property, or the system.The manuals for this system use the terms DANGER, WARNING, CAUTION, and NOTICEto point out hazards and to designate a degree or level of seriousness. Familiarizeyourself with the following definitions and their significance.Table 2: Definitions of Safety ConventionsSafety Convention DescriptionDANGER Indicates an imminent hazard, which, if not avoided will result in death orserious injury.WARNING Indicates a potential hazard of unsafe practice, which, if not avoided, couldresult in death or serious injury.CAUTION Indicates a potential hazard or unsafe practice, which, if not avoided, couldresult in moderate or minor injury.NOTICE Indicates a potential hazard or unsafe practice, which, if not avoided, couldresult in the loss or destruction of property or dataSafety HazardsThe following safety messages alert you to potentially hazardous conditions thatcould arise during the normal use of this product and recommend steps that can betaken to avoid those conditions. Safety messages pertaining to hazardous conditionsthat may arise during specific actions may also be provided during the discussion ofthose actions in this or other manuals for this product.WARNING:EQUIPMENT MALFUNCTION - Any attempt by unauthorized personnel to servicethe device could result in equipment malfunction and void the warranty. This8 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Safety Informationequipment contains no user-serviceable parts. Refer servicing to authorizedservice personnel.CAUTION:EQUIPMENT COMPATIBILITYCompatibility is critical to safe and effective use of this device. Please contactyour local sales or service representative prior to installation to verify equipmentcompatibility.WARNING:PERSONAL INJURY-STUMBLING HAZARD - Patients can become entangled in thecables and leadwires connected to the device, which could cause the patient tostumble or trip.Route cables and leadwires in a way to avoid creating a stumbling hazard: keepthem off the floor, and route leadwires away from the patient’s legs and thehealthcare provider’s work area.WARNING:MAGNETIC AND ELECTRICAL INTERFERENCE - Magnetic and electric fields caninterfere with the acquisition of ECG readings.Make sure that all peripheral components operated in the vicinity of the devicecomply with the relevant EMC requirements. X-ray equipment, MRI devices,radio systems (cellular phones) and so forth, are possible sources of interferencebecause they may emit higher levels of electromagnetic radiation. Verify theperformance of the system before use.WARNING:EXPLOSION HAZARD - Using this device in the presence of anesthetic vapors orliquids can cause explosions.Do not use this device in the presence of anesthetic vapors or liquids. Only personswith adequate training in the correct use of this device may use this device.WARNING:EQUIPMENT FAILURE - Polarizing electrodes (stainless steel or silver constructed)may cause the electrodes to retain a residual charge after defibrillation. A residualcharge blocks acquisition of the ECG signal.Whenever patient defibrillation is a possibility, use non-polarizing electrodes(silver-silver chloride construction) for ECG monitoring.CAUTION:EQUIPMENT DAMAGEDevices intended for emergency application must not be exposed to lowtemperatures during storage and transport to avoid moisture condensation at theapplication site. Wait until all moisture has vaporized before using the device.2109599-003 A MAC™ 7 Resting ECG Analysis System 9
Safety InformationWARNING:PERSONAL INJURY - Contact with patients during defibrillation can cause seriousinjury or death.Do not contact patients during defibrillation. Patient signal inputs labeled withthe CF symbols with paddles are protected against damage resulting fromdefibrillation voltages. To ensure proper defibrillator protection, use only GEHealthcare recommended cables and leadwires. Proper placement of defibrillatorpaddles in relation to the electrodes is required to ensure successful defibrillation.CAUTION:EXPLOSION HAZARDDo NOT use in the presence of flammable anesthetics vapors or liquids.WARNING:INTERPRETATION HAZARD - Results of the automated QT analysis are notconsidered a diagnosis.A qualified physician or cardiologist must review and confirm the measurementsand waveforms recorded by the system. It should be used only as an adjunct tothe clinical history, symptoms, and results of other tests.WARNING:INTERPRETATION HAZARD - Computerized interpretation is only significant whenused in conjunction with clinical findings.A qualified physician must overread all computer-generated tracings.WARNING:IMPROPER USE - This is a prescriptive device.This equipment is intended for use by or under the direct supervision of a licensedhealthcare practitioner.WARNING:BATTERY EXPLOSION HAZARD - Batteries may explode in fires.Do not dispose of the battery by fire or burning. Follow local environmentalguidelines concerning disposal and recycling.WARNING:ELECTRIC SHOCK HAZARD/SYSTEM MALFUNCTION - Liquids inside a device cancause electric shock or system malfunction.Do not allow liquids to enter the device. If liquids enter the device, turn it off andinform your service technician. Do not use the device until it is checked by aservice technician.WARNING:ELECTRIC SHOCK - Improper connection of this equipment may cause electricshock.To avoid risk of electric shock, this equipment must only be connected to a supplymains with protective earth.10 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Safety InformationWARNING:EQUIPMENT MALFUNCTION/INTERFERENCE - Use of portable phones or other radiofrequency (RF) emitting equipment near the system may cause unexpected oradverse operation.Do not use portable phones or other electronic equipment that may emit radiofrequency (RF) near this system.WARNING:EQUIPMENT MALFUNCTION/INTERFERENCE - Do not use the equipment or systemadjacent to, or stacked with, other equipment.If adjacent or stacked use is necessary, test the equipment or system to verifynormal operation in the configuration in which you are using it.WARNING:ACCESSORIES/COMPONENTS - Adding accessories or components, or modifyingthe medical device or system, may result in increased EMISSIONS or decreasedIMMUNITY of the device or system.CAUTION:ACCESSORIES/COMPONENTS - Ensure that all cables are less than 3 meters long.Cable lengths greater than 3 meters may result in decreased IMMUNITY of thedevice or system.CAUTION:ACCESSORIES (SUPPLIES)To ensure patient safety, use only parts and accessories manufactured orrecommended by GE Medical Systems Information Technologies. Parts andaccessories used must meet the requirements of the applicable IEC 60601 seriessafety standards and essential performance standards, and/or the systemconfiguration must meet the requirements of the IEC 60601-1-1 medical electricalsystems standard.CAUTION:ACCESSORIES (EQUIPMENT)The use of ACCESSORY equipment not complying with the equivalent safetyrequirements of this equipment may lead to a reduced level of safety of theresulting system. Consideration relating to the choice shall include: Use of theaccessory in the PATIENT VICINITY; and Evidence that the safety certification of theACCESSORY has been performed in accordance to the appropriate IEC 60601-1and/or IEC 60601-1-1 harmonized national standard.WARNING:DATA LOSS - Formatting the device’s internal flash drive erases all the data inmemory and returns the device to its factory settings.If possible, back up or record any data that you do not want to lose beforeperforming the following procedure.2109599-003 A MAC™ 7 Resting ECG Analysis System 11
Safety InformationWARNING:EQUIPMENT FAILURE AND HEALTH HAZARDS - Failure on the part of all responsibleindividuals, hospitals or institutions, employing the use of this system, toimplement the recommended maintenance schedule, may cause equipmentfailure and possible health hazards. The sole responsibility rests with theindividuals, hospitals, or institutions utilizing the system. The manufacturer doesnot, in any manner, assume the responsibility for performing the recommendedmaintenance schedule, unless an Equipment Maintenance Agreement exists.CAUTION:DISPOSAL HAZARDDisposable devices are intended for single use only. They should not be reused asperformance may degrade or contamination could occur.CAUTION:DISPOSAL HAZARD - At the end of its service life, the product described in thismanual, 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 itsrepresentatives.CAUTION:INTERCONNECTED DEVICES - When several items of medical equipment areinterconnected, summation of leakage current must meet the leakage current asper IEC 60601-1.Connect the device only to the GE approved supplies and accessories.CAUTION:ISOLATION FROM SUPPLY MAINSDo not position the device so that it is difficult to operate the disconnection of theAC power supply of the device.Supplies and AccessoriesThis section is in regard to the supplies and accessories you may purchase for yourproduct.You should use only supplies and accessories recommended by GE Healthcare. For alist of recommendations, refer to the supplies and accessories guide for this system.Contact GE Healthcare before using anything that is not recommended for thissystem.12 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Product and Packaging Information3Product and Packaging InformationHardware Label LocationsThe following illustrations and table describe the labels and their location on yourdevice and its packaging.2109599-003 A MAC™ 7 Resting ECG Analysis System 13
Product and Packaging Information14 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Product and Packaging InformationTable 3: Label Descriptions on the Device and PackagingItem Label Location Description1 Device AddressLabel and RatingPlateBack of thedeviceProvides regulatory and cautionary information. See"Device Address Label and Rating Plate" on page 17for an explanation of the label.2 Country-specificLabelBack of thedeviceContains registration information for China and LatinAmerica.3 Serial NumberLabelBack of thedeviceIdentifies this device. See "Serial Number Label" onpage 17 for a description of the label contents.4 Option CodeLabelBack of thedeviceUse the option codes to setup the purchased optionsin your system.5 Wireless Label Back of thedeviceDepending on the customer's wireless option, the labelwill differ:Default wireless option:FIPS wireless option:6 MAC AddressLabelBack of thedeviceIndicates the MAC address of the device.2109599-003 A MAC™ 7 Resting ECG Analysis System 15
Product and Packaging InformationItem Label Location Description7 Shipping Label On the shippingpackageIndicates the shipping address where the device isdelivered.8 RED Lable On the shippingpackageContains registration information of Radio EquipementDirective.9 EnvironmentalSymbolsThese symbols containing warning and cautionindicators are required for shipping. For a fulldescription of symbols, see "Symbol Descriptions" onpage 18.10 Battery ShippingLabelOn the shippingpackageFRAGILE—Lithium Ion batteries can cause fire ifdamaged.16 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Equipment Identification4Equipment IdentificationSerial Number LabelThe serial number label is in the following format:Table 4: Serial Number Label FormatItem Description1 Product Name2 Date of Manufacture in YYYY-MM-DD Format3 Country of Origin4 Device Serial Number5 UDI Barcode6 Product Part NumberDevice Address Label and Rating PlateThe device address label and rating plate is in the following format:2109599-003 A MAC™ 7 Resting ECG Analysis System 17
Equipment IdentificationTable 5: Device Address Label and Rating Plate FormatItem Description1 Product name2 Manufacturer name and address3 Electrical rating of the device4 SymbolsSee "Symbol Descriptions" on page 18 for a description of the symbols used on thislabel.Symbol DescriptionsThe following table describes symbols or icons that are on the device or its packaging.Any symbol on your device or packaging with markings in color indicates theremay be a danger, warning, or mandatory action. Any symbol on your device orpackaging that is in black and white provides additional information or may indicatea caution. Familiarity with these symbols assists in the proper use and disposal of theequipment.For equipment symbols not shown, refer to the original equipment manufacturer(OEM) manuals.Table 6: Symbols, Icons, and DescriptionsSymbol DescriptionCatalog or Orderable Part NumberIndicates the manufacturer’s catalog or part number.Serial NumberIndicates the manufacturer's serial number.18 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Equipment IdentificationSymbol DescriptionBatch Code or Lot NumberIndicates the manufacturer's batch code or lot number.Date of Manufacture (Year-Month-Date)Indicates the original manufacture date for this device.ManufacturerIndicates the name and address for the manufacturer of this device. It mayalso include the date it was manufactured.Rx OnlyUS Federal law restricts this device to sale by or on the order of a physician.12SLIndicates the device uses the Marquette™ 12SL ECG Analysis Program toanalyze and interpret ECG readings.IPxx IP Code (Ingress Protection Rating)Classifies and rates the degree of protection provided against the intrusionof solid objects (such as body parts like hands and fingers, dust, accidentalcontact), and liquids.The first numeral (x) represents the degree of protection against the ingressof solid objects.The second numeral (x) represents the degree of protection against theingress of liquids.For products with an IPxx rating, see the Classification of Medical Device inthis chapter for a description of that rating. Not all products have an IPxxrating.Regulatory Compliance Mark (RCM)Indicates compliance with electrical safety, EMC, EME andtelecommunications requirements, as applicable to the product.Required for Australia and New Zealand.Wireless CommunicationIndicates that that the equipment can be connected through wirelesscommunication.Waste Electrical and Electronic Equipment (WEEE)Indicates this equipment contains electrical or electronic componentsthat must not be disposed of as unsorted municipal waste but collectedseparately. Contact an authorized representative of the manufacturer forinformation concerning the decommissioning of your equipment.2109599-003 A MAC™ 7 Resting ECG Analysis System 19
Equipment IdentificationSymbol DescriptionFollow Instructions For UseRead and understand the operator's manual before using the device orproduct.As a mandatory action sign, this symbol is identified by a blue backgroundand white symbol.This Way UpIndicates the correct upright position of the package.Keep DryIndicates that you need to keep the container away from rain and othersources of moisture.Can Be RecycledIndicates you may recycle this material or device. Recycle or dispose of inaccordance with local, state, or country laws.Temperature LimitsIndicates the upper and lower temperature limits for the transportationand handling of this package. They are indicated next to the upper andlower horizontal lines.Humidity LimitsIndicates upper and lower humidity limits for the transportation andhandling of this package. They are indicated next to the upper and lowerhorizontal lines.Atmospheric LimitsIndicates the upper and lower barometric pressure limitations for thetransportation and handling of this package. They are indicated next to theupper and lower horizontal lines.Defibrillation-proof Type CF Applied PartIdentifies a defibrillation-proof type CF applied part on medical equipmentthat complies with IEC 60601–1.This device meets the requirements for protection against electric shock foran earth-free (floating) applied part (one intended for contact with patients)for cardiac application.No User– or Field-serviceable PartsDo not open or disassemble the device for any reason.Protective Earth (ground)Identifies the terminal of a protective earth (ground) electrode or anyterminal that is intended for connection to an external conductor forprotection against electric shock in case of a fault.20 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Equipment IdentificationSymbol DescriptionDo Not StackIndicates that you should not stack the container or place a load on thecontainer.CAUTION:ELECTRIC SHOCK - Indicates the presence of hazardous energy circuitsor electric shock hazards.To reduce the risk of electric shock hazards, do not open this enclosure.Refer servicing to qualified personnel.EquipotentialityConnect non-grounded peripheral devices to ensure equipotential.Environmental Friendly Use Period (EFUP)Per Chinese standard SJ/T11364–2014, indicates the number of years fromthe date of manufacture during which you can use the product before anyrestricted substances are likely to leak, causing a possible environmental orhealth hazard.NOTE:• If the device contains less than the maximum concentration ofrestricted substances, the symbol contains a lowercase e• This is also referred to as China RoHS.FragileIndicates the contents are fragile. Handle with care.CAUTION:SAFETY GROUND PRECAUTION - Pulling on the cable can cause thecord to deteriorate resulting in electrical problems.Remove the power cord from the mains source by grasping the plug.DO NOT pull on the cable.Contains <heavy metal chemical symbol>Indicates this equipment contains heavy metal and must not be disposedof as unsorted municipal waste but collected separately. The exampleshows Lithium Ion.Pushing Prohibited2109599-003 A MAC™ 7 Resting ECG Analysis System 21
Equipment IdentificationSerial Number FormatEach device has a serial number that uniquely identifies the device and providesimportant information about the device. The serial number format is shown in thefollowing illustration:Table 7: Serial Number FormatItem Name Description1 Product Code A three-character code that uniquely identifies the product line.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, 17 =2017 (and so on).3 Fiscal WeekManufacturedA two-digit code identifying the week the device was manufactured.Values range from 01 to 52. GE Healthcare's fiscal weekscorrespond to the calendar week. For example, 01 = the first week inJanuary.4 Product Sequence A four-digit number identifying the order in which this device wasmanufactured.Values range from 0001 to 9999.5 Manufacturing Site A one-letter code identifying the site where the device wasmanufactured.For example, F = Milwaukee, N = Freiburg, P = Bangalore, W = Wuxi,H = Helsinki, S = Mexico6 MiscellaneousCharacteristicA one-letter code identifying manufacturing status.For example, P = the device is a prototype, R = the device wasrefurbished, U = the device was upgraded to meet the specificationsof another product code, A = device is in production.Unique Device IdentifierMedical devices require a unique marking for identification—the Unique DeviceIdentifier (UDI). In the event that you need the UDI for this product, check the productlabel on the back of the device.22 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Electromagnetic Compatibility (EMC)5Electromagnetic Compatibility (EMC)Before installing or using the device or system, be aware of the proximity of knownradio frequency (RF) sources, such as the following:• Radio and TV stations• Portable and mobile RF communication devices (cell phones, two-way radios)• X-ray, CT, or MRI devicesThese devices are also possible sources of interference as they may emit higherlevels of electromagnetic radiation.WARNING:EQUIPMENT MALFUNCTIONUse of this equipment adjacent to or stacked with other equipment should beavoided because it could result in improper operation. If such use is necessary, thisequipment and the other equipment should be observed to verify that they areoperating normally.Portable RF communications equipment (including peripheralssuch as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cablesspecified by the manufacturer. Otherwise, degradation of the performance of thisequipment could result.WARNING:EQUIPMENT MALFUNCTION OR INTERFERENCEUse of this equipment adjacent to or stacked with other equipment should beavoided because it could result in improper operation. If such use is necessary, thisequipment and the other equipment should be observed to verify that they areoperating normally.WARNING:PATIENT SAFETY/EQUIPMENT FAILUREUse of accessories, transducers and cables other than those specified or providedby the manufacturer of this equipment could result in increased electromagneticemissions or decreased electromagnetic immunity of this equipment and result inimproper operation.2109599-003 A MAC™ 7 Resting ECG Analysis System 23
Electromagnetic Compatibility (EMC)Guidance and Manufacturer’s Declaration—Electromagnetic EmissionsThe system described in this document is intended for use in the following specifiedelectromagnetic environment. It is the responsibility of the customer or user to ensurethat this system is used in such an environment.Table 8: EMC Emissions TestEmissions Test Compliance Electromagnetic EnvironmentRF emissions (Radiated)EN 55011Group 1Class BRF emissions (Conducted)• EN 55011Group 1Class BThis device uses RF energyonly for its internal function.Therefore, its RF emissionsare very low and are not likelyto cause any interference innearby electronic equipment.Class B equipment issuitable for use in allestablishments, includingdomestic establishments andthose directly connected tothe public low-voltage powersupply network that suppliesbuildings used for domesticpurposes.Harmonic emissionsIEC 61000-3-2Class AVoltage fluctuations/FlickeremissionsIEC 61000-3-3CompliesGuidance and Manufacturer’s Declaration—Electromagnetic ImmunityThe system described in this document is intended for use in the following specifiedelectromagnetic environment. It is the responsibility of the customer or user to ensurethat this system is used in such an environment.24 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Electromagnetic Compatibility (EMC)Table 9: EMC Immunity TestImmunity Test EN60601 Test Level Compliance Level ElectromagneticEnvironment–GuidanceElectrostatic discharge(ESD)IEC 61000-4-2± 8 kV contact± 15 kV air± 8 kV contact± 15 kV airFloors should be wood,concrete, or ceramictile. If the floors arecovered with syntheticmaterial, the relativehumidity should be atleast 30%.Electrical FastTransient/burst (EFT)IEC 61000-4-4± 2 kV for power supplylines± 1 kV for input/outputlines± 2 kV for power supplylines± 1 kV for input/outputlinesMains power shouldbe that of a typicalcommercial or hospitalenvironment.SurgeIEC 61000-4-5± 1 kV line(s) to line(s)± 2 kV line(s) to earth± 1 kV line(s) to line(s)± 2 kV line(s) to earthMains power shouldbe that of a typicalcommercial or hospitalenvironment.Voltage dips, shortinterruptions, andvoltage variations onpower supply inputlinesIEC 61000-4-11< 5% Ut (> 95% dip inUt) for 0.5 cycles< 40% Ut (> 60% dip inUt) for 5 cycles< 70% Ut (> 30% dip inUt) for 25 cycles< 5% Ut (> 95% dip inUt) for 5 s< 5% Ut (> 95% dip inUt) for 0.5 cycles< 40% Ut (> 60% dip inUt) for 5 cycles< 70% Ut (> 30% dip inUt) for 25 cycles< 5% Ut (> 95% dip inUt) for 5 sMains power shouldbe that of a typicalcommercial or hospitalenvironment.Ut is the AC mainsvoltage prior toapplication of the testlevel.If the user requirescontinued systemoperation duringpower mainsinterruptions, it isrecommended thatthe system is poweredfrom an applicablyrated uninterruptiblepower supply or abattery.Power frequency(50/60 Hz) magneticfieldIEC 61000-4-830 A/m 30 A/m Power frequencymagnetic fieldsshould be at levelscharacteristic of atypical location in atypical commercial orhospital environment.2109599-003 A MAC™ 7 Resting ECG Analysis System 25
Electromagnetic Compatibility (EMC)Immunity Test EN60601 Test Level Compliance Level ElectromagneticEnvironment–GuidanceConducted RFIEC 61000-4-63 Vrms0.15 MHz to 80 MHz6 Vrms in ISM bandsbetween 0.15 MHz and80 MHz3 Vrms0.15 MHz to 80 MHz6 Vrms in ISM bandsbetween 0.15 MHz and80 MHzRecommendedseparation distance:d = 12√PRadiated RFIEC 61000-4-33 V/m at 80 to 2700MHz, AM Modulation9 to 28 V/m at 385to 6000 MHz, FM orDigital Modulation3 V/m at 80 to 2700MHz, AM Modulation9 to 28 V/m at 385to 6000 MHz, FM orDigital Modulationd = 1.2 √P 80 MHz to800 MHzd = 2.3 √P 800 MHz to2.5 GHzAt 80 MHz and 800MHz, the higherfrequency rangeapplies.Recommendedseparation distance:where P is themaximum outputpower rating ofthe transmitter inwatts (W) accordingto the transmittermanufacturer, and dis the recommendedseparation distance inmeters (m).Field strengths fromfixed RF transmitters,as determined by anelectromagnetic sitesurvey, should be lessthan the compliancelevel in each frequencyrange.Interference mayoccur in the vicinityof equipment markedwith the followingsymbol:26 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Electromagnetic Compatibility (EMC)Immunity Test EN60601 Test Level Compliance Level ElectromagneticEnvironment–GuidanceNOTE:• Do not use portable or mobile RF communications equipment closer to any part of thesystem, including the cables, than the recommended separation distance calculated for theequation applicable to the frequency of the transmitter.• 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,theoretically, be predicted with accuracy. To assess the electromagnetic environmentdue to fixed RF transmitters, consider conducting an electromagnetic site survey. If themeasured field strength in the location the system is used exceeds the applicable RFcompliance level listed in this table, observe the system to verify normal operation. Ifabnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the system.• At 80 MHz and 800 MHz, the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected bythe reflection from structures, objects, and people.Recommended Separation DistancesThe following table provides the recommended separation distances (in meters)between portable and mobile RF communication equipment and the systemdescribed in this manual, for equipment and systems that are not life-supporting.The system is intended for use in the electromagnetic environment in which radiatedRF disturbances are controlled. The customer or the user of the system can helpprevent electromagnetic interference by maintaining the following recommendedminimum distance between portable and mobile RF communications equipment(transmitters) and the system, according to the maximum output power of thecommunications equipment.Table 10: Recommended Separation DistancesSeparation Distance (meters) According to Frequency of Transmitter1150 kHz to 80 MHzd (meters) = 3.5/V1 x √ Pd (meters) for V1 = 3 Vrms80 MHz to 800 MHz2d = 3.5/E1 x √ Pd for E1 = 3 V/m800 MHz to 2.5 GHzd = 7/E1 x √ Pd for E1 = 3 V/mRatedMaximumOutputPower ofTransmitterin Watts (W)Meters Feet Meters Feet Meters Feet0.01 0.117 0.383 0.117 0.383 0.233 0.7660.1 0.369 1.210 0.369 1.210 0.738 2.4211 1.167 3.828 1.167 3.828 2.333 7.6552109599-003 A MAC™ 7 Resting ECG Analysis System 27
Electromagnetic Compatibility (EMC)Separation Distance (meters) According to Frequency of Transmitter1150 kHz to 80 MHzd (meters) = 3.5/V1 x √ Pd (meters) for V1 = 3 Vrms80 MHz to 800 MHz2d = 3.5/E1 x √ Pd for E1 = 3 V/m800 MHz to 2.5 GHzd = 7/E1 x √ Pd for E1 = 3 V/mRatedMaximumOutputPower ofTransmitterin Watts (W)Meters Feet Meters Feet Meters Feet10 3.689 12.104 3.689 12.104 7.379 24.208100 11.667 38.276 11.667 38.276 23.333 76.552NOTE:1 These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects, and people.2 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.For transmitters rated at a maximum output power not listed above, estimate the recommendedseparation distance d in meters (m) using the equitation applicable to the frequency of thetransmitter, where P is the maximum output power rating of the transmitter in watts (W) accordingto the transmitter manufacturer.28 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Wireless Regulations6Wireless RegulationsThe wireless and wired LAN functionality of the MAC 7 is used to retrieve ECG ordersand send ECG reports to an ECG Management System. In addition, the wirelessand wired LAN functionality can be used to interface to other hospital informationsystems to provide additional data to the care giver operating the electrocardiograph.These tasks are an adjunct to the device’s intended use of acquiring, analyzing,displaying and printing an electrocardiogram. Because the wireless and wiredLAN functionality is not required for the device to fulfill its intended use, networkperformance is not critical to the performance of the device. Furthermore, the MAC 7does not transmit any real-time data or alarm information over the network. NetworkQuality of Service (QoS) parameters such as reliability of data transmission, latency,transfer rate, error rate, and priority levels are not critical to the MAC 7 functionalityand are not specified.FCC ComplianceThis device complies with part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) This device may not cause harmful interference, and (2)this device must accept any interference received, including interference that maycause undesired operation.CAUTION:Changes or modifications to this unit not expressly approved by the partyresponsible for compliance could void the user's authority to operate theequipment.NOTE:This equipment has been tested and found to comply with the limits for a ClassB digital device, pursuant to part 15 of the FCC Rules. These limits are designedto provide reasonable protection against harmful interference in a residentialinstallation. This equipment generates, uses and can radiate radio frequencyenergy and, if not installed and used in accordance with the instructions, maycause harmful interference to radio communications. However, there is noguarantee that interference will not occur in a particular installation. If thisequipment does cause harmful interference to radio or television reception, which2109599-003 A MAC™ 7 Resting ECG Analysis System 29
Wireless Regulationscan be determined by turning the equipment off and on, the user is encouragedto try to correct the interference by one or more of the following measures:• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit different from that to whichthe receiver is connected.• Consult the dealer or an experienced radio/TV technician for help.Limited by local law regulations, version for North America does not have regionselection option.To satisfy FCC RF exposure requirements, a separation distance of 20 cm or moreshould be maintained between the antenna of this device and persons during deviceoperation.To ensure compliance, operations at closer than this distance is not recommended.IC ComplianceThis device contains licence-exempt transmitter(s)/receiver(s) that comply withInnovation, Science and Economic Development Canada’s licence-exempt RSS(s).Operation is subject to the following two conditions:1. This device may not cause interference.2. This device must accept any interference, including interference that may causeundesired operation of the device.L’émetteur/récepteur exempt de licence contenu dans le présent appareil estconforme aux CNR d’Innovation, Sciences et Développement économique Canadaapplicables aux appareils radio exempts de licence. L’exploitation est autorisée auxdeux conditions suivantes:1. L’appareil ne doit pas produire de brouillage;2. L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillageest susceptible d’en compromettre le fonctionnement.This equipment complies with radio frequency exposure limits set forth by theInnovation, Science and Economic Development Canada for an uncontrolledenvironment.This equipment should be installed and operated with a minimum distance of 20 cmbetween the device and the user or bystanders.This device must not be co-located or operating in conjunction with any otherantenna or transmitter.Cet équipement est conforme aux limites d'exposition aux radiofréquences définies parla Innovation, Sciences et Développement économique Canada pour un environnementnon contrôlé.30 MAC™ 7 Resting ECG Analysis System 2109599-003 A
Wireless RegulationsCet équipement doit être installé et utilisé avec un minimum de 20 cm de distanceentre le dispositif et l'utilisateur ou des tiers.Ce dispositif ne doit pas être utilisé à proximité d’une autre antenne ou d’un autreémetteur.The device for operation in the band 5150-5250 MHz is only for indoor use to reducethe potential for harmful interference to co-channel mobile satellite systems;les dispositifs fonctionnant dans la bande de 5 150 à 5 250 MHz sont réservésuniquement pour une utilisation à l'intérieur afin de réduire les risques de brouillagepréjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux;RED InformationThe MAC 7 embedded wireless module complies with CE RED 2014/53/EU.This product is restricted to indoor use.Frequency Range 2.4 GHz frequency bands: 2.4-2.483 GHz5 GHz frequency bands: 5.15-5.35 GHz, 5.47-5.725 GHzMaximum RF outputpower20 dBm2109599-003 A MAC™ 7 Resting ECG Analysis System 31
GE Medical SystemsInformation Technologies, Inc.8200 West Tower AvenueMilwaukee, WI 53223 USATel:+1 414 355 5000Tel: +1 800 558 7044 (US Only)www.gehealthcare.comGE Medical Systems Information Technologies, Inc., a General Electric Company, going to market as GE Healthcare.

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