Philips Expression MR400 - Equipment Classification (According to IEC 60601-1)

ExpressionMR400InstructionsforUseImportant Information1‐7
ELECTROMAGNETICCOMPATIBILITY(EMC)
ThisPhilipsproductcomplieswithrelevantinternationalandnationallawandstandardsonEMC
(electromagneticcompatibility)forthistypeofproductwhenusedasintended.Suchlawsand
standardsdefineboththepermissibleelectromagneticemissionlevelsfromproductand
its
requiredimmunitytoelectromagneticinterferencefromexternalsources.
OtherelectronicproductsexceedingthelimitsdefinedinsuchEMCstandardscould,under
unusualcircumstances,affecttheoperationoftheproduct.
•MedicalelectricalproductsneedsspecialprecautionsregardingEMC,andneedstobe
installedandputintoserviceaccordingtoEMC
informationprovidedinthisInstructionsfor
Use.
•Theuseofaccessoriesandcablesotherthanthosespecified,mayresultinincreased
emissionordecreasedimmunitylevels.
•Theproductshouldnotbeusedadjacenttoorstackedwithotherproductsandthatif
adjacentorstackeduseisnecessary,itshould
beobservedtoverifynormaloperation.
CAUTION
Portable and Mobile Phones
Portable and mobile RF communications can affect medical electrical equipment. Use caution
when using such communication devices within the specified range of medical electrical devices.
The Expression MR400 MRI Patient Monitoring System may be interfered with by other
equipment with CISPR emission requirements.
Equipment Classification (According to IEC 60601-1)
According to the type of protection against
electrical shock:
Class I equipment
According to the degree of protection against
electrical shock:
Type CF (defibrillator-proof) equipment
According to the degree of ingress protection: Rated IP21: Protected against access to
hazardous parts and the ingress of solid
foreign objects greater than 12.5mm (0.5
inch); and, protected against vertically
dripping liquid.
According to the methods of sterilization or
disinfection:
Non-sterilizable; use of liquid surface
disinfectants only
According to the mode of operation: Continuous operation
Equipment not suitable for use in the presence of flammable anesthetic mixture with air,
oxygen or nitrous oxide.