Devilbiss Guidance And Manufacturer's Declaration - DeVillbiss PULSEDOSE COMPACT Bedienungsanleitung

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 Group 1
RF Emissions CISPR 11 Class B
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
SE-1000
Compliance 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
N/A
domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domestic purposes.
N/A
IEC 60601 Test Compliance
Level Level
±6kV contact
Complies
±8kV air
3 V/m 80MHz to
Complies
2.5GHz
3 Vrms 150kHz
N/A
to 80MHz
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:
EN - 13