Electromagnetic Immunity - Dräger Tropic plus Instrucciones De Uso

Electromagnetic immunity

The medical device is intended for use in an electromagnetic envi-
ronment as specified below. The user must ensure that the medi-
cal 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 interrup-
tions on AC mains input lines
(IEC 61000-4-11)
Radiated radio frequency
(IEC 61000-4-3)
Conducted radio frequency
(IEC 61000-4-6)
1) For P insert the highest possible "equivalent isotropic radiated power" of the adjacent radio frequency transmitter. In the vicinity of equipment marked
EIRP,
with the symbol , interference 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.
2) 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 Tropic plus
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: 10 V/m
2)
150 kHz to 80 MHz: 3 V
Compliance level (medical
device)
±6 kV
±8 kV
±2 kV
±1 kV
±2 kV
±1 kV
3 A/m
–100 %
–60 %
–30 %
–100 %
3 V/m
3 V
3 V
English
Electromagnetic environ-
ment
Floors should be wood, con-
crete, or ceramic tiles. If floors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
Mains voltage quality should be
that of a typical commercial or
hospital environment.
Mains voltage quality should be
that of a typical commercial or
hospital environment.
Power frequency magnetic
fields should be at levels char-
acteristic of a typical commer-
cial or hospital environment.
Mains voltage quality should be
that of a typical commercial or
hospital environment. If the user
of the medical device requires
continued operation during
mains power supply interrup-
tions, it is recommended that
the medical device is powered
from an uninterruptible power
supply or a battery.
Recommended minimum dis-
tance to portable and mobile
radio frequency transmitters
with transmission power P
EIRP
to the medical device including
its lines:
1)
(1.84 m x ÷P )
EIRP
Recommended minimum dis-
tance to portable and mobile
radio frequency transmitters
with transmission power P
EIRP
to the medical device including
its lines:
1)
(1.84 m x ÷P )
EIRP
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