Guidance And Manufacturer's Declaration - DeVilbiss iGo Series Servicehandbuch

G U I D A N C E & M A N U FA C T U R E R ' S D E C L A R AT I O N
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 Class B
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
Compliance Electromagnetic Environment – Guidance
This device uses RF energy only for its internal function. Therefore, its RF
Group 1 emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
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.
Complies
Compliance
IEC 60601 Test Level Level
±6kV contact
Complies
±8kV air
3 V/m 80MHz to 2.7GHz Complies
3 Vrms 150kHz to
Complies
80MHz
±2kV power line
Complies
±1kV I/O lines
±1kV differential
Complies
±2kV common
3 A/m Complies
>95% dip 0.5 cycle
60% dip 5 cycles
Complies
70% dip 25 cycles
95% dip 5 secs.
Electromagnetic Environment - Guidance
Floors should be wood, concrete, or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30%
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:
Mains power quality should be that of a typical
commercial or hospital environment.
Power frequency magnetic fields should be at levels
characteristic of a typical 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 power mains
interruptions, it is recommended that the device be
powered from an uninterruptible power supply or battery.
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