Guidance And Manufacturer's Declaration - DeVilbiss Healthcare iGo 306CH Mode D'emploi

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 w th 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 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 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 - 6
Compliance Electromagnetic Environment – guidance
This device uses RF energy only for its internal function. Therefore, its RF emissions
Group 1 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
Class B directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Complies
IEC 60601 Test Compliance
Level Level
±6kV contact
Complies
±8kV air
3 V/m 80MHz to 2.5GHz Complies
3 Vrms 150kHz to 80MHz Complies
±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.
A-306CH