Specifications
304 Instructions for Use Apollo SW 4.5n
Part Number: 9053586, 3rd edition
Electromagnetic immunity
The medical device is intended for use in an electromag-
netic environment as specified below. The user must ensure
that the medical device is used in such an environment.
Immunity
against
IEC 60601-1-2 test level
Compliance level
(medical device)
Electromagnetic environment
Electrostatic discharge,
ESD
(IEC 61000-4-2)
Contact discharge: ±6 kV ±6 kV Floors should be wood, concrete or
ceramic tiles. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Air discharge: ±8 kV ±8 kV
Electrical fast transients
/ bursts
(IEC 61000-4-4)
Power supply lines: ±2 kV ±2 kV Mains voltage quality should be that of a
typical commercial or hospital
environment.
Longer input / output lines:
±1 kV
±1 kV
Surges on AC mains
lines
(IEC 61000-4-5)
Common mode: ±2 kV ±2 kV Mains voltage quality should be that of a
typical commercial or hospital
environment.
Differential mode: ±1 kV ±1 kV
Power frequency
magnetic field 50/60 Hz
(IEC 61000-4-8)
3 A/m 3 A/m No equipment with extraordinarily strong
power frequency magnetic fields (power
transformers, etc.) should be operated in
close vicinity to the medical device.
Voltage dips and short
interruptions on AC
mains input lines
(IEC 61000-4-11)
Dip >95 %, 0.5 periods >95 %, 0.5 per. Mains voltage quality should be that of a
typical commercial or hospital environ-
ment. If the medical device is to continue
operating during interruptions of the mains
power supply, it is recommended that the
medical device is powered from an uninter-
ruptible power supply or a battery.
Dip 60 %, 5 periods 60 %, 5 per.
Dip 30 %, 25 periods 30 %, 25 per.
Dip >95%, 5seconds >95%, 5sec.
Radiated RF
(IEC 61000-4-3)
80 MHz to 2.5 GHz:
10 V/m
10 V/m Recommended minimum distance to
portable and mobile radio frequency
transmitters with transmission power
P
EIRP to the medical device including its
lines:
(1.84 m x
√PEIRP/watt)
1)
(6.04 ft x √PEIRP/watt)
1)
RFcoupled into lines
(IEC 61000-4-6)
150 kHz to 80 MHz:
10 V inside ISM bands
10 V Recommended minimum distance to porta-
ble and mobile radio frequency transmitters
with transmission power P
EIRP to the med-
ical device including its lines:
(1.84 m x
√PEIRP/watt)
1)
(6.04 ft x √PEIRP/watt)
1)
)
150 kHz to 80 MHz:
3 V outside ISM bands
2)
3V
1) For PEIRP, insert the highest possible "equivalent isotropic radiated power" of the adjacent radio frequency transmitter. In the vicinity of
equipment marked 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.
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