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MUSE v9 Regulatory and Safety Manual_SM_2059568-016_B
Model 750 Temperature Management Unit Operator's Manual
18 pgs470.91 Kb0
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GE MUSE v9 Regulatory and Safety Manual_SM_2059568-016_B Model 750 Temperature Management Unit Operator's Manual

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Page 1
GEHealthcare
Familiarize yourself with this information before attempting to use this system. Keep this manual with your Operator Manual and equipment at all times, and periodically review it.
MUSE
TM
v9
CardiologyInformationSystems RegulatoryandSafetyGuide
2059568-016RevisionB
MUSEv9CardiologyInformationSystem English ©2015GeneralElectricCompany. AllRightsReserved.
Page 2
PublicationInformation
TheinformationinthismanualappliesonlytoMUSE
TM
v9CardiologyInformationSystem.Itdoesnotapplytoearlierproductversions.Due
tocontinuingproductinnovation,specicationsinthismanualaresubjecttochangewithoutnotice.
MUSE,MAC,andMarquettearetrademarksownedbyGEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectricCompanygoing tomarketasGEHealthcare.Allothertrademarkscontainedhereinarethepropertyoftheirrespectiveowners.
Thisproductcomplieswiththerequirementsconcerningmedicaldevicesfromthefollowingregulatorybodies.Formoreinformationabout compliance,refertotheRegulatoryandSafetyGuideforthisproduct.
Thedocumentpartnumberandrevisionareatthebottomofeachpage.Therevisionidentiesthedocument’supdatelevel.Therevision historyofthisdocumentissummarizedinthefollowingtable.
Revision
A
B
Date
8April2015InitialRelease
28July2015Commercialrelease.
Comments
ToaccessotherGEHealthcareDiagnosticCardiologydocuments,gototheCommonDocumentationLibrary(CDL),locatedat
www.gehealthcare.com/documents,andclickCardiology.
ToaccessOriginalEquipmentManufacturer(OEM)documents,gotothedevicemanufacturer'swebsite.
NOTE:
Allillustrationsinthisdocumentareprovidedasexamplesonly.Dependingonsystemconguration,screensinthedocumentmay differfromthescreensonyoursystem.
Allpatientnamesanddataarectitious.Anysimilaritytoactualpersonsiscoincidental.
Ifyourequireadditionalassistance,contactyourGEHealthcarerepresentative,orGEHealthcaresupportatoneofthefollowingnumbers:
•NorthAmerica:1-800-558-7044
•Europe:+497614543-0
•Asia:+862138777888
Thisdocumentisintendedasasupplementto,notasubstitutefor,thoroughproducttraining.Ifyouhavenotreceivedtrainingontheuseof thesystem,youshouldrequesttrainingassistancefromGEHealthcare.
Toseeavailabletraining,gototheGEHealthcaretrainingwebsite(www.gehealthcare.com/training).SelectEducation>Product Education-Technical>DiagnosticCardiology.
Formoreself-pacedcourseofferings,tools,andreferenceguidesyoumaynduseful,pleasevisittheGEHealthcareEducationStoreat
www.gehealthcare.com/educationstore.
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Contents
1RegulatoryInformation
2SafetyInformation
IndicationsforUse......................................................................................5
Contraindications.......................................................................................5
PrescriptionDeviceStatement...................................................................6
MUSESystemAccuracy...............................................................................6
ResponsibilityofthePurchaser/Customer.................................................6
ModemRequirements.................................................................................6
SafetyConventions.....................................................................................7
SafetyHazards............................................................................................7
SecurityUpdates.........................................................................................8
3ProductandPackagingInformation
SoftwareLabel..........................................................................................11
SymbolDescriptions.................................................................................12
4EquipmentIdentication
SerialNumberFormat...............................................................................15
UniqueDeviceIdentier(UDI)...................................................................16
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RegulatoryInformation

Familiarizeyourselfwiththisinformationbeforeattemptingtousethissystem. KeepthismanualwithyourOperatorManualandequipmentatalltimes,and periodicallyreviewit.
Thissectionprovidesinformationabouttheregulatorycomplianceofthissystem. Thesystemsoftwareisconsideredmedicalsoftware.Assuch,itwasdesignedand manufacturedtotheappropriatemedicalregulationsandcontrols.

IndicationsforUse

TheMUSE™CardiologyInformationSystemisintendedtostore,accessandmanage cardiovascularinformationonadultandpediatricpatients.Theinformationconsists ofmeasurements,text,anddigitizedwaveforms.TheMUSE™CardiologyInformation Systemprovidestheabilitytoreviewandeditelectrocardiographicprocedureson screen,throughtheuseofreviewing,measuring,andeditingtoolsincludingECGserial comparisonandinterpretive12-leadanalysis.TheMUSE™CardiologyInformation Systemisintendedtobeusedunderthedirectsupervisionofalicensedhealthcare practitioner,bytrainedoperatorsinahospitalorfacilityprovidingpatientcare.
1

Contraindications

WARNING:
CONTRAINDICATION:Thesystemisnotintendedforprimarymonitoring.
CAUTION:
CONTRAINDICATION:Thesystemisnotintendedforpediatricserialcomparison.
WARNING:
CONTRAINDICATION:Thesystemisnotintendedforreal-timepatientmonitoring.
WARNING:
CONTRAINDICATION:Thesystemisnotintendedforthetransferoftime-sensitive data.
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RegulatoryInformation

PrescriptionDeviceStatement

CAUTION:
UnitedStatesfederallawrestrictsthisdevicetosalebyorontheorderofa physician.

MUSESystemAccuracy

Accuracyofthesystemis100%datareproduction,dependentonzoomsettings,and resolutionofdisplayand/orprinterbeingused.

ResponsibilityofthePurchaser/Customer

Thecustomerisresponsibleforprovidingappropriatedesks,chairs,electricalwall outlets,networkconnections,andanalogphonelines,andforlocatinganyofthe systemcomponentsdescribedinthismanualincompliancewithalllocal,state,and nationalcodes.

ModemRequirements

Lackofdatasecuritymaycompromisepatientprivacy.GEHealthcarerecommends thatyoushouldtakeappropriatestepstosecuretheprivacyofcommunicationon yournetworkwhenusingthisproduct.
ModemssuppliedbyGEHealthcarearedesignedtocomplywithapplicablecountry requirements(suchasUSAFCC47CFR68,CEEUR&TTE1999/5/EC).Refertothe deviceforaregistrationnumberandringerequivalencenumber(REN).Themodem isdesignedforuseonstandarddevicetelephonelines.Connectiontotelephone company-providedcoinservice(centralofceimplementedsystems)isprohibited. Connectiontopartylinesserviceissubjecttostatetariffs.
Ananalogtelephonelineisrequired.AdigitalPBXlinedoesnotwork.Ifyouhaveany questionsaboutyourtelephoneline,suchashowmanypiecesofequipmentyoucan connecttoit,thetelephonecompanyprovidesthisinformationuponrequest.
Theregistrationnumberandringerequivalencenumber(REN)arelistedonthe equipmentlabel.Toassureproperservicefromyourtelephonecompany,connectno morethanveRENspertelephoneline.Insomecases,youmaynotbeabletouse veRENsonagivenline.
Ifanyofyourtelephoneequipmentisnotoperatingproperly,youshouldimmediately removeitfromyourtelephoneline,asitmaycauseharmtothetelephonenetwork.If thetelephonecompanynotesaproblem,theymaytemporarilydiscontinueservice. Whenpractical,theynotifyyouinadvanceofthisdisconnection.Ifadvancenotice isnotfeasible,youarenotiedassoonaspossible.Whenyouarenotied,youare giventheopportunitytocorrecttheproblemandyouareinformedofyourrighttole acomplaint.
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SafetyInformation

SafetyConventions

2
Thissectionprovidesinformationaboutthesafeuseofthissystem.
Disregardingthesafetyinformationprovidedinthismanualisconsideredabnormal useofthissystemandcouldresultininjury,dataloss,oravoidedwarranty.
AHazardisasourceofpotentialinjurytoaperson,property,orthesystem.
ThismanualusesthetermsDANGER,WARNING,CAUTION,andNOTICEtopointout hazardsandtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwith thefollowingdenitionsandtheirsignicance.
DenitionsofSafetyConventions
Safety Convention
DANGER
WARNING
CAUTION
NOTICE

SafetyHazards

Thefollowingsafetymessagesalertyoutopotentiallyhazardousconditionsthat couldariseduringthenormaluseofthisproductandrecommendstepsthatcanbe takentoavoidthoseconditions.Safetymessagespertainingtohazardousconditions
Denition
Indicatesanimminenthazard,which,ifnotavoided,willresultindeath orseriousinjury.
Indicatesapotentialhazardorunsafepractice,which,ifnotavoided, couldresultindeathorseriousinjury.
Indicatesapotentialhazardorunsafepractice,which,ifnotavoided, couldresultinmoderateorminorinjury.
Indicatesapotentialhazardorunsafepractice,which,ifnotavoided, couldresultinthelossordestructionofpropertyordata.
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SafetyInformation
thatmayariseduringspecicactionsmayalsobeprovidedduringthediscussionof thoseactionsinthisorothermanualsforthisproduct.
WARNING:
PATIENTSAFETY:Allcomputer-generatedtracingsshouldbeoverreadbya qualiedphysician.
CAUTION:
DATACORRUPTION:InstallationofsoftwarenotspeciedbyGEHealthcaremay causedamagetotheequipment,lossorcorruptionofdata.
DONOTloadanysoftwareotherthanthatspeciedbyGEHealthcareontothe system.
WARNING:
INCORRECTTREATMENT:IfarecordcontainingadefaultPID(forexample,
000000911)comesintotheMUSEsystemwithapatientname,ittriggersa mismatch.Whenyouopenthenameeld,thesystemreportdisplaysUnknown Patient,andtheReportNamedisplaysthepatient’sname(forexample,JohnDoe).
IfthereportdoesbelongtoJohnDoe,changethePIDnumbertoJohnDoe’s correctPID.
WARNING:
INCORRECTTREATMENT:FailuretohaveauniquePatientID(PID)inpatient demographicsmaycauseincorrectpatientdataassociatedwiththePID.
AlwaysassigntheproperPIDandnamebeforetransmissiontothesystem.Do notconrmpatientrecordscontainingdefaultPIDs.RefertotheMUSECardiology InformationSystemOperator’sManualforinformationonsettingupadefaultPID.
CAUTION:
LOSSOFDATA:Databasebackupistheresponsibilityofthecustomer.
GEMedicalSystemsInformationTechnologies,Inc.isnotresponsiblefordataloss ofanykindasaresultofcustomer'sfailuretobackupdata.

SecurityUpdates

TheGEHealthcareProductSecurityDatabaseidentieswhichsecuritypatches fromthird-partyvendorshavebeenapprovedforuseonGEHealthcareproducts. Thedatabasedoesnotcontaininformationaboutthird-partypatchesthatarenot relatedtosecurity.
NOTE:
Inordertoaccessthissite,youneedanSSOnumber.Ifyoudonothaveone,you canobtainoneduringtheloginprocess.
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Tondsecuritypatchesforyourproduct,dothefollowing:
1.BrowsetotheGEHealthcareProductSecurityDatabase:http://
prodsecdb.gehealthcare.com
TheGEHealthcareSingleSignOn(SSO)pageopens.
2.EnteryourSSOuserIDandpasswordandclickLogIn.
TheHomePageopens.
NOTE:
IfyoudonothaveanSSOaccount,clickSignUpNow!andfollow theinstructionstocompletetheregistrationforanaccount.Afterthe registrationiscompleted,theaccountisgeneratedandtheHomePage opens.
3.ClickSearchandselectProductPatchTable.
TheProduct–PatchMappingSearchResultpageopens,providingyoualist ofallthepatchesthatmatchthesearchcriteriaandtheirPatchAssessment Status.PatcheswithaPatchApprovedstatuswereveriedbyGEHealthcare andyoumaydownloadthemfromthethird-partyvendorandinstallthemon theidentiedproduct.
SafetyInformation
Formoreinformationaboutthepatch,clickonthelinkforthatpatchinPatch AssessmentDetails.
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SafetyInformation
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ProductandPackagingInformation

Thissectionidentiesthefollowing:
•Softwarelabelsandtheirlocations
•SymbolDescriptionspage12

SoftwareLabel

ThefollowingillustrationandtabledescribethelabelonyourCDorDVD.
3
DescriptionsoftheCD/DVDLabel
Item
1
2UDI
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Description
ProductName
UniqueDeviceIdenticationrequiredforallmedicaldevices.Itconsistsofthe softwareUDIplustheCD/DVDproductiondate.Itisrequiredwhenreportinga damagedordefectivedisk.
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ProductandPackagingInformation
DescriptionsoftheCD/DVDLabel(cont'd.)
Item
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Description
2DBarcode
SoftwareTitle
SoftwareVersion
VolumeNumber
PartNumber
Revision
DateofManufacture
GOST-RMark
CEMark
Legalmessage
PrescriptionNotice
CountryofOrigin
Manufacturer’sNameandAddress
CopyrightNotice

SymbolDescriptions

Thefollowingtabledescribessymbolsoriconsthatareonthedeviceoritspackaging.
Anysymbolonyourdeviceorpackagingwithmarkingsincolorindicatestheremay beadanger,warning,ormandatoryaction.Anysymbolonyourdeviceorpackaging thatisinblackandwhiteprovidesadditionalinformationormayindicateacaution. Familiaritywiththesesymbolsassistsintheuseanddisposaloftheequipment.
Forequipmentsymbolsnotshown,refertotheoriginalequipmentmanufacturer (OEM)manuals.
Symbol
Description
CatalogorOrderablePartNumber
Indicatesthemanufacturer'scatalogorpartnumber.
SerialNumber
Indicatesthemanufacturer'sserialnumber.
BatchCodeorLotNumber
Indicatesthemanufacturer'sbatchcodeorlotnumber.
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ProductandPackagingInformation
Symbol
Description
DateofManufacture(Year-Month)
Indicatestheoriginalmanufacturedateforthisdevice.
Manufacturer
Indicatesthenameandaddressforthemanufacturerofthisdevice. Itmayalsoincludethedateitwasmanufactured.
AuthorizedRepresentativeintheEuropeanCommunity
Indicatesthenameandaddressoftheauthorizedrepresentative intheEuropeanCommunityforthisdevice.
RxOnly
USFederallawrestrictsthisdevicetosalebyorontheorderofa physician.
ConsultInstructionsforUse
Consulttheoperatinginstructions.
FollowInstructionsForUse
Readandunderstandtheoperator'smanualbeforeusingthe deviceorproduct.
CAUTION:
CONSULTACCOMPANYINGDOCUMENTS Theremaybespecicwarningsorprecautionsassociatedwith thedevicethatarenototherwisefoundonthelabel.
Consulttheaccompanyingdocumentationformore informationaboutsafelyusingthisdevice.
CEMark
IndicatesthedeviceorproductconformswithapplicableEU (EuropeanUnion)directives.
PCT(GOST-R)Mark
IndicatesthedeviceorproductconformswithapplicableRussian Gosstandarttechnicalandsafetystandards.
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ProductandPackagingInformation
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EquipmentIdentication

SerialNumberFormat

Eachdevicehasaserialnumberthatuniquelyidentiesitandprovidesimportant information.Youneedtheproductcodeandtheentireserialnumberbeforeservicing orrequestingsupportforyourproduct.Theserialnumberformatisshowninthe followingillustration:
SerialNumberFormat
4
ItemName
1
2
3
4
5
6
Description
ProductCodeThree-lettercodethatuniquelyidentiestheproductline.
YearManufacturedTwo-digitcodeidentifyingtheyearthedevicewas
manufactured.Valuesrangefrom00to99 Forexample:00=2000,04=2004,05=2005(andsoon).
FiscalWeek Manufactured
ProductSequenceFour-digitnumberidentifyingtheorderinwhichthis
ManufacturingSiteOne-lettercodeidentifyingthesitewherethedevicewas
Miscellaneous Characteristic
Two-digitcodeidentifyingtheweekthedevicewas manufactured. Valuesrangefrom01to52.GEHealthcare'sscalweeks correspondtothecalendarweek.Forexample,01=rst weekinJanuary.
devicewasmanufactured.Valuesrangefrom0001to
9999.
manufactured.Forexample,F=Milwaukee,N=Freiburg, P=Bangalore,W=Wuxi,H=Helsinki.
One-lettercodeidentifyingmanufacturingstatus.For example,P=deviceisaprototype,R=devicewas refurbished,U=devicewasupgradedtomeetthe specicationsofanotherproductcode,A=deviceisin production.
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EquipmentIdentication
UniqueDeviceIdentier(UDI)
Medicaldevicesrequireauniquemarkingforidentication—theUniqueDevice Identier(UDI).IntheeventthatyouneedtoaccesstheUDIforthissoftwareproduct, onthemenubarselectHelp>About.
IftheUDIdoesnotdisplay,contactyourGEHealthcareservicerepresentative.
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Page 18
GEMedicalSystems InformationTechnologies,Inc. 8200WestTowerAvenue Milwaukee,WI53223USA Tel:+14143555000
+18005587044(USOnly)
Fax:+14143553790
GEMedicalSystems InformationTechnologiesGmbH MunzingerStraße5 79111FreiburgGermany Tel:+497614543-0 Fax:+497614543-233
AsiaHeadquarters
GEMedicalSystems InformationTechnologies,Inc. Asia;GE(China)Co.,Ltd. 1HuatuoRoad ZhangjiangHi-techParkPudong Shanghai,People'sRepublicofChina201203 Tel:+862138777888 Fax:+862138777451
GEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectricCompany,goingtomarketas GEHealthcare.
www.gehealthcare.com
0459
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