Electromagnetic Immunity; Electromagnetic Immunity / Radiofrequency Mobile Equipment - Satelec Implant Center 2 User Manual

13. 2 ELECTROMAGNETIC IMMUNITY

I C 2 is intended for use in the electromagnetic environment specified in the table below. The user
MPLANT ENTER
and/or installer must ensure that the device is used in such an electromagnetic environment.
Immunity test
Electrostatic discharge
± 6KV contact
(ESD)
± 8KV air
IEC 61000-4-2.
Electrical fast
transients ± 2KV for power supply lines
IEC 61000-4-4.
Surges ± 1KV differential mode
IEC 61000-4-5. ± 2KV common mode
<5% U
cycles.
Voltage dips, short
interruptions and 40% U
voltage variations
IEC 61000-4-11. 70% U
<5% U

13. 3 ELECTROMAGNETIC IMMUNITY / RADIOFREQUENCY MOBILE EQUIPMENT

The I C 2 is intended for use in the electromagnetic environment specified in the table below. The
MPLANT ENTER
user and/or installer must ensure that the device is used in such an electromagnetic environment.
Immunity test
Portable and mobile radiofrequency communications devices must not be used near the I
Conducted disturbance,
radiofrequency fields.
IEC61000-4-6
Radiated
radiofrequency
electromagnetic field.
IEC61000-4-3
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:
26
IEC 60601 test level
(>95% dip in U ) for 0.5
T T
(60% dip in U ) for 5 cycles
T T
(30% dip in U ) for 25 cycles
T T
(>95% dip in U ) for 250 cycles
T T
IEC 60601 test level
recommended and calculated according to the frequency and power of the emitter.
3 V/m
150 KHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance level
± 6KV contact
± 8KV air
± 2KV for power supply lines
± 1KV differential mode
± 2KV common mode
<5% U (>95% dip in U ) for 0.5
T T
cycles.
40% U (60% dip in U ) for 5 cycles
T T
70% U (30% dip in U ) for 25 cycles
T T
<5% U (>95% dip in U ) for 250
T T
cycles
Compliance level
MPLANT
Recommended separation distance:
3 V/m
d = 1.2
d = 1.2
d = 2.3
3 V/m
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).
Electromagnetic environment - guidance
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%.
Mains power quality should be that of a typical
commercial or hospital environment (hospital, clinic).
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
If the use of the I C
MPLANT ENTER
operation during power mains interruption, it is
recommended that the product be powered from a
separate power supply (UPS, etc.).
Electromagnetic environment - guidance
C 2 (including its cables) at a distance less than that
ENTER
80MHz to 800MHz.
800MHz to 2.5GHz.
2 requires continued