Satelec Implant Center 2, User Manual

Page: 26 / 248

13. 2 ELECTROMAGNETIC IMMUNITY
I
MPLANT
C
ENTER
2 is intended for use in the electromagnetic environment specified in the table below. The user
and/or installer must ensure that the device is used in such an electromagnetic environment.
13. 3 ELECTROMAGNETIC IMMUNITY / RADIOFREQUENCY MOBILE EQUIPMENT
The I
MPLANT
C
ENTER
2 is intended for use in the electromagnetic environment specified in the table below. The
user and/or installer must ensure that the device is used in such an electromagnetic environment.
26
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2.
± 6KV contact
± 8KV air ± 6KV contact
± 8KV air
Floors must be wood, concrete, cement or tiled.
If floors are covered with synthetic material (carpet,
etc.), the relative humidity must be at least 30%.
Electrical fast
transients
IEC 61000-4-4.
± 2KV for power supply lines ± 2KV for power supply lines
Mains power quality should be that of a typical
commercial or hospital environment (hospital, clinic).
Surges
IEC 61000-4-5. ± 1KV differential mode
± 2KV common mode ± 1KV differential mode
± 2KV common mode Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
IEC 61000-4-11.
<5% U
T
(>95% dip in U
T
) for 0.5
cycles.
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 250 cycles
<5% U
T
(>95% dip in U
T
) for 0.5
cycles.
40% U
T
(60% dip in U
T
) for 5 cycles
70% U
T
(30% dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
) for 250
cycles
Mains power quality should be that of a typical
commercial or hospital environment.
If the use of the I
MPLANT
C
ENTER
2 requires continued
operation during power mains interruption, it is
recommended that the product be powered from a
separate power supply (UPS, etc.).
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile radiofrequency communications devices must not be used near the I
MPLANT
C
ENTER
2 (including its cables) at a distance less than that
recommended and calculated according to the frequency and power of the emitter.
Conducted disturbance,
radiofrequency fields.
IEC61000-4-6
3 V/m
150 KHz to 80 MHz
3 V/m
Recommended separation distance:
d = 1.2
Radiated
radiofrequency
electromagnetic field.
IEC61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2 80MHz to 800MHz.
d = 2.3 800MHz to 2.5GHz.
Where P is the maximum power rating of the emitter in watts (W)
according to the manufacturer's specifications and d is the
recommended minimum separation distance in meters (m).
The electromagnetic field strengths of fixed radiofrequency emitters, as determined by an electromagnetic environment measurement (a), must be less
than the compliance level in each frequency range (b).
Interference may occur near equipment marked with the symbol below: