Dräger DigiFlow Gebrauchsanweisung Seite 31

Electromagnetic immunity
The medical device is intended for use in an
electromagnetic environment as specified below.
The user must ensure that the medical device is
used in such an environment.
Immunity against
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Electrical fast transients/bursts
(IEC 61000-4-4)
Surge on AC mains lines/surges
(IEC 61000-4-5)
Power frequency magnetic field
(50/60 Hz) (IEC 61000-4-8)
Voltage dips and short interruptions on
AC mains input lines (IEC 61000-4-11)
Radiated radio frequency
(IEC 61000-4-3)
Conducted radio frequency
(IEC 61000-4-6)
* For P , insert the highest possible "equivalent isotropic radiated power" of the adjacent radio frequency transmitter. In the vicinity of equipment marked with the symbol
EIRP
can occur. Field strengths from fixed, portable, or mobile radio frequency transmitters at the location of the medical device should be less than 3 V/m in the frequency range from 150 kHz
to 2.5 GHz and less than 1 V/m above 2.5 GHz.
** ISM bands in this frequency range are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27,283 MHz; 40.66 MHz to 40.70 MHz.
Instructions for use DigiFlow
IEC 60601-1-2 Test level
Contact discharge: ±6 kV
Air discharge: ±8 kV
Power supply lines: ±2 kV
Longer input lines/output lines: ±1 kV
Common mode: ±2 kV
Differential mode: ±1 kV
3 A/m
Dip >95 %, 0.5 periods
Dip 60 %, 5 periods
Dip 30 %, 25 periods
Dip >95 %, 5 seconds
80 MHz to 2.5 GHz: 3 V/m
**
150 kHz to 80 MHz: 3 V
Compliance level Electromagnetic environment
(medical device)
±6 kV Floors should be wood, concrete, or ceramic tiles. If
floors are covered with synthetic material, the relative hu-
±8 kV
midity should be at least 30 %.
N/A N/A
N/A
N/A N/A
N/A
3 A/m Power frequency magnetic fields should be at levels
characteristic of a typical commercial or hospital environ-
ment.
N/A N/A
N/A
N/A
N/A
3 V/m Recommended minimum distance to portable and mobile
radio frequency transmitters with transmission power
P to the medical device including its lines:
EIRP
(1.84 m x √P
N/A N/A
*
)
EIRP
, interference
English
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