GE CARESCAPE ONE - CE Marking Application Year; Service Requirements

Systemintroduction
ThecharactersusedintheUDImarkingrepresentspecicidentiers.
Intheexampleabove:
Deviceidentier:
●(01)=GS1globaltradeitemnumber(GTIN)ofthedevice.
●1234567891234=Globaltradeitemnumber.
Productionidentiers:
●(21)=GS1applicationidentierfortheserialnumberofthedevice.
●SJN14241237HA=Serialnumber.
●(11)=GS1applicationidentierforthemanufacturingdateof
thedevice.
●150628=Manufacturingdate:year-month-day(YYMMDD).
Notethatforsomeproducttypestheproductionidentiercanhave
otherelementsinsteadoftheoneslistedabove:
●(10)=GS1applicationidentierforthebatchorlotnumber,
followedbythebatchorlotnumber.
●(17)=GS1applicationidentierfortheexpirationdateofthe
device,followedbytheexpirationdate.
CEmarkingapplicationyear
CEmarkingapplicationyear:2018
Servicerequirements
Followtheservicerequirementslistedbelow.
●Referservicingoftheequipmenttoqualiedservicepersonnelonly.Service
personnelservicingthisproductmusthaveanappropriatetechnicalqualication,
orequivalentworkexperience,andbefamiliarwiththeservicerequirements
describedinthismanualandinanyrelatedservicedocumentation.Servicetraining
fortheproductisrecommended.
●Anyunauthorizedattempttorepairequipmentunderwarrantyvoidsthatwarranty.
●Itistheuser'sresponsibilitytoreporttheneedforservicetoGEortooneoftheir
authorizedagents.
●Failureonthepartoftheresponsibleindividual,hospital,orinstitutionusingthis
equipmenttoimplementasatisfactorymaintenanceschedulemaycauseundue
equipmentfailureandpossiblehealthhazards.
●Regularmaintenance,irrespectiveofusage,isessentialtoensurethatthe
equipmentwillalwaysbefunctionalwhenrequired.
WARNING
Donotperformanyserviceactivitiesonthemonitorinthe
patientvicinitywhileapatientisconnectedtothemonitor.
CAUTION
DISPOSAL.Attheendofitsservicelife,theproductdescribed
inthismanual,aswellasitsaccessories,mustbedisposedof
incompliancewiththeguidelinesregulatingthedisposalof
eachproduct.Ifyouhaveanyquestionsconcerningdisposal
ofaproduct,pleasecontactGEoritsrepresentatives.
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CARESCAPEONE2094480-001
CARESCAPE ONE User Manual DRAFT 26 October 2017