1‐8ImportantInformationExpressionMR400InstructionsforUse
Electromagnetic Compatibility (EMC)
Thedeviceisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Giventhe
device’selectromagneticemissionsandimmunitycharacteristics,thecustomerorusershould
assurethatthedeviceisusedwithinsuchanenvironment.Thefollowinginformationis
mandatedbyIEC60601‐1‐2,theinternationalstandard fortheelectromagnetic
compatibility
(EMC)ofmedicalelectricalequipment.
Radios
INDUSTRYCANADASTATEMENT
ThisdevicecomplieswithIndustryCanadalicense‐exemptRSSstandard(s).Operationissubjectto
thefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevicemust
acceptanyinterference,includinginterferencethatmaycauseundesiredoperationofthedevice.
Leprésentappareilestconformeaux
CNRd'IndustrieCanadaapplicablesauxappareilsradio
exemptsdelicence.L'exploitationestautoriséeauxdeuxconditionssuivantes:(1)l'appareilne
doitpasproduiredebrouillage,et(2)l'utilisateur del'appareildoitacceptertoutbrouillage
radioélectriquesubi,mêmesilebrouillageestsusceptibled'encompromettrelefonctionnement.
FCCCOMPLIANCESTATEMENT
Changes or modifications not expressly approved could void your authority to use this equipment
Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowingtwo
conditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemustaccept
anyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.
FrequencyRange:2402–2482MHz
ModulationType:GFSK
WPUEIRP:
4.2dBm(peak)
wECGandwSpO2EIRP:0dBm(peak)
The use of accessories, transducers and cables other than those specified in the accessory list
accompanying this Instructions for Use (with the exception of transducers and cables sold by
Invivo (Royal Philips) for the equipment or system as replacement parts for internal
components) will result in increased emissions or decreased immunity of the equipment or
system.