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Guidance and manufacturer's declaration - electromagnetic immunity
The EndoDrive PLUS is intended for use in the electromagnetic environment specified below. The customer or the user of the EndoDrive PLUS should assure that it is
used in such an environment.
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
Immunity test
IEC60601 test level
Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC61000-4-2
Electrical fast transient/burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC61000-4-11
Power frequency (50/60Hz)
magnetic field
IEC61000-4-8
±(2,4) 6 kV contact
±(2,4) 8 kV air
±2kV for power supply lines
±1kV for input/output
±1kV line(s) to line(s)
±2kV line(s) to earth
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
3 A/m
Compliance level
±(2,4) 6 kV contact
±(2,4) 8 kV air
±2kV for power supply lines
±1kV for input/output
±1kV line(s) to line(s)
±2kV line(s) to earth
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
3 A/m
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30%.
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.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
EndoDrive PLUS requires continued operation during
power mains interruptions, it is recommended that the
EndoDrive PLUS be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
Guidance and manufacturer's declaration - electromagnetic immunity
The EndoDrive PLUS is intended for use in the electromagnetic environment specified below. The customer or the user of the EndoDrive PLUS should assure that it is
used in such an environment.
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobiles radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the EndoDrive PLUS is used exceeds the applicable RF
compliance level above, the EndoDrive PLUS should be observed to verity normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the EndoDrive PLUS.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Immunity test
IEC60601 test level
Electromagnetic environment - guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3Vrms
150 kHz to 80MHz
3V/m
80MHz to 2.5 GHz
Compliance level
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the EndoDrive PLUS, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 P
d = 1.2 P 80MHz to 800MHz
d = 2.3 P 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters as determined by an
electromagnetic site survey, should be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
