EN - 8
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 configuration 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 specified 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 fluctuations / flicker
emissions
Complies
guidance and manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified 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 floors 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 fixed 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 field
IEC 61000-4-8
3 A/m
Complies
Power frequency magnetic fields 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.
NE-525
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