EN - 15SE-DV54-1
DEVILBISS GUIDANCE AND MANUFACTURER’S DECLARATION
WARNING
MedicalElectricalEquipmentneedsspecialprecautionsregardingElectromagneticCompatibility[EMC]andneeds
tobeinstalledandputintoserviceaccordingtotheEMCinformationprovidedintheaccompanyingdocuments.
PortableandMobileRFCommunicationsEquipmentcanaffectMedicalElectricalEquipment.
Theequipmentorsystemshouldnotbeusedadjacenttoorstackedwithotherequipmentandthatifadjacentor
stackeduseisnecessary,theequipmentorsystemshouldbeobservedtoverifynormaloperationinthe
congurationinwhichitwillbeused.
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 – Emissions All Equipment and
Systems
Thisdeviceisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomeroruserofthisdevice
should assure that it is used in such an environment.
EmissionsTest Compliance ElectromagneticEnforcement–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
Radiated and Conducted
Emissions
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.
Harmonics
IEC 61000-3-2
Class A
Flicker
IEC 61000-3-3
Complies
ImmunityTest IEC60601TestLevel ComplianceLevel ElectromagneticEnvironment-Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or ceramic
tile.Ifoorsaresynthetic,therelativehumidity
shouldbeatleast30%.
Electrical Fast
Transient/burst
IEC 61000-4-4
±2kV on AC Mains ±2kV on AC Mains
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
±1kV Differential
±2kV Common
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
>95%Dipfor
0.5 Cycle
60%Dipfor
5 Cycles
30%Dipfor
25 Cycles
>95%Dipfor
5 Seconds
>95%Dipfor
0.5 Cycle
60%Dipfor
5 Cycles
30%Dipfor
25 Cycles
>95%Dipfor
5 Seconds
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.