Product Info

Safety Information
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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Guidance and manufacturer’s declaration – electromagnetic immunity
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in the electromagnetic
environment specied below. The customer or the user of the WaveWriter Alpha or WaveWriter Alpha Prime System
should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment
– guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact:
± 8 kV
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact:
± 8 kV
Floors should be wood, concrete
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Note: Applies to external devices.
Power frequency (50/60
Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic
elds should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment. Magnetic elds
from common appliances are not
expected to affect the device.
Guidance and manufacturer’s declaration – electromagnetic immunity
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in the electromagnetic
environment specied below. The customer or the user of the WaveWriter Alpha or WaveWriter Alpha Prime System
should assure that it is used in such an environment.
Immunity Test IEC 60601 -1-2
Test Level
Compliance
Level
Electromagnetic Environment - guidance
Conducted RF
IEC 61000-4-6
(ETS only)
3 Vrms
150 kHz to 80
MHz
3 Vrms
150 kHz to 80
MHz
6 Vrms in ISM
and amateur
radio bands
between 150 kHz
and 80 MHz
Professional healthcare facility environment and home
healthcare environment.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,7
GHz
10 V/m
80 MHz to
2,7 GHz
Professional healthcare facility environment and home
healthcare environment.
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey,
a
should
be less than the compliance level in each frequency
range. Interference may occur in the vicinity of
equipment marked with the symbol shown below: