DeVilbiss Healthcare PULSEDOSE COMPACT PD1000 Guide De L'utilisateur page 13

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
Immunity Test
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
This device has been tested to and meets the EMC requirements of EN60601-1-2. Do not place the device
near other equipment or devices that create or attract electromagnetic fields. Examples of such equipment
are defibrillators, diathermy equipment, CB radios, microwave ovens, etc. Field strengths from fixed
transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should
be considered. If the measured field strength in the location in which the unit is used exceeds the applicable
RF compliance level above, the unit should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the unit.
A-1000
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
IEC 60601 Test Compliance
Level Level
±2kV power line
N/A
±1kV I/O lines
±1kV differential
N/A
±2kV common
3 A/m Complies
>95% dip 0.5
cycle
60% dip 5 cycles
N/A
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:
Electromagnetic Environment - Guidance
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.
EN - 13