DeVilbiss iFill 535D - Devilbiss Guidance and Manufacturers Declaration

EN - 8
A-535D
DEVILBISS GUIDANCE AND MANUFACTURER’S DECLARATION
WARNING
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic
Compatibility [EMC] information provided in the accompanying documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
Theequipmentorsystemshouldnotbeusedadjacenttoorstackedwithotherequipmentandthatifadjacentorstackeduseisnecessary,theequipmentor
system should be observed to verifynormaloperationinthecongurationinwhichitwillbeused.
NOTE– The EMC tables and other guidelines provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the
Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without
disturbing other Equipment and Systems or non-medical electrical equipment.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Thisdeviceisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserofthisdeviceshouldassurethatitisusedinsuchan
environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions CISPR 11 Group 1
This device uses RF energy only for its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11 Class B
This device is suitable for use in all establishments including domestic and those directly connected
to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2 Class B
Voltageuctuations/icker
emissions
Complies
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Thisdeviceisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserofthisdeviceshouldassurethatitisusedinsuchan
environment.
Immunity Test IEC 60601 Test Level
Compliance
Level Electromagnetic Environment - Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
Complies
Floorsshouldbewood,concrete,orceramictile.Ifoorsarecoveredwith
synthetic material, the relative humidity should be at least 30%
Radiated RF IEC 61000-4-3 3 V/m 80MHz to 2.5GHz Complies
FieldstrengthsoutsidetheshieldedlocationfromxedRFtransmitters,as
determined by an electromagnetic site survey, should be less than 3 V/m.
Interference may occur in the vicinity of equipment marked with the following
symbol:
Conducted RF IEC 61000-4-6 3 Vrms 150kHz to 80MHz Complies
Electrical fast transient IEC 61000-
4-4
±2kV power line
±1kV I/O lines
Complies
Mains power quality should be that of a typical commercial or hospital
environment.
Surge IEC 61000-4-5
±1kV differential
±2kV common
Complies
Powerfrequencymagneticeld
IEC 61000-4-8
3 A/m Complies
Powerfrequencymagneticeldsshouldbeatlevelscharacteristicofatypical
location in a typical commercial or hospital environment.
Voltage dips, short interrupts and
voltage variations on power supply
input lines IEC 61000-4-11
>95% dip 0.5 cycle
60% dip 5 cycles
70% dip 25 cycles
95% dip 5 secs.
Complies
Mains power quality should be that of a typical commercial or hospital
environment. If the user of this device requires continued operation during
power mains interruptions, it is recommended that the device be powered from
an uninterruptible power supply or battery.