Philips Expression MR400 - Intended Use; Compatibility

1‐2ImportantInformationExpressionMR400InstructionsforUse
Intended Use
ThisPhilipsproductisintendedtobeusedandoperatedonlyinaccordancewiththesafety
proceduresandoperatinginstructionsgiveninthisInstructionsforUseforthepurposesfor
whichitwasdesigned.Thepurposesforwhichtheproductisintendedisgivenbelow.However,
nothingstatedinthisInstructions
forUsereducesusers’responsibilitiesforsoundclinical
judgmentandbestclinicalprocedure.
TheExpressionMR400MRIPatientMonitoringSystemisintendedforusebyhealthcare
professionalstomonitorvitalsignsofpatientsundergoingMRIprocedures andtoprovidesignals
forthesynchronizationoftheMRIscanner.
Useandoperation
ofthisproductissubjecttothelawinthejurisdiction(s)inwhichtheproduct
isbeingused.Usersmustonly install,useandoperatetheproductinsuchwaysasdonotconflict
withapplicablelaws,orregulations,whichhavetheforceoflaw.Usesoftheproductfor
purposes
otherthanthoseintendedandexpresslystatedbythe manufacturer,aswellas
incorrectuseoroperation,mayrelievethemanufacturer(orhisagent)fromallorsome
responsibilityforresultantnon‐compliance,damageorinjury.
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
Compatibility
Theproductdescribedinthismanualshouldnotbeusedincombinationwithotherproductsor
componentsunlesssuchotherproductsorcomponentsareexpresslyrecognizedascompatible
byPhilipsMedicalSystems.[Alistofsuchproductsandco mponentsisavailablefromthe
manufacturer].Changesand/oradditionstotheproductshould
onlybecarriedoutbyPhilips
MedicalSystemsorbythirdpartiesexpresslyauthorizedbyPhilipsMedicalSystemstodoso.
Suchchangesand/oradditionsmustcomplywithallapplicablelawsandregulationsthathave
theforceoflawwithinthejurisdiction(s)concerned,andwithbestengineeringpractice.
Warning
WARNING
Changes and/or additions to the product that are carried out by persons without the
appropriate training and/or using unapproved spare parts may lead to the PMS warranty
being voided. As with all complex technical products, maintenance by persons not
appropriately qualified and/or using unapproved spare parts carries serious risks of damage
to the product and of personal injury.