Devilbiss Guidance And Manufacturer's Declaration; Guidance And Manufacturer's Declaration - Electromagnetic Emissions; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - DeVilbiss iFill 535I Manual De Uso

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
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker
emissions
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
Electrostatic discharge (ESD)
IEC 61000-4-2
Radiated RF IEC 61000-4-3
Conducted RF IEC 61000-4-6
Electrical fast transient IEC 61000-
4-4
Surge IEC 61000-4-5
Power frequency magnetic field
IEC 61000-4-8
Voltage dips, short interrupts and
voltage variations on power supply
input lines IEC 61000-4-11
EN - 8
Compliance
Group 1
Class B
Class B
Complies
IEC 60601 Test Level
±6kV contact
±8kV air
3 V/m 80MHz to 2.5GHz
3 Vrms 150kHz to 80MHz
±2kV power line
±1kV I/O lines
±1kV differential
±2kV common
3 A/m
>95% dip 0.5 cycle
60% dip 5 cycles
70% dip 25 cycles
95% dip 5 secs.
Electromagnetic Environment – Guidance
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.
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.
Compliance
Level Electromagnetic Environment ­ Guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with
Complies
synthetic material, the relative humidity should be at least 30%
Field strengths outside the shielded location from fixed RF transmitters, as
Complies
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:
Complies
Complies
Mains power quality should be that of a typical commercial or hospital
environment.
Complies
Power frequency magnetic fields should be at levels characteristic of a typical
Complies
location in a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital
environment. If the user of this device requires continued operation during
Complies
power mains interruptions, it is recommended that the device be powered from
an uninterruptible power supply or battery.
SE-535I