Maillefer Instruments
CH – 1338 Ballaigues
Switzerland
ZF1902109.X / 03/ 2009 –updated 03/2011
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The handpiece is intended for use in the electromagnetic environment specified below. The Customer or the user of
the handpiece should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –guidance
Electrostatic
discharge
(ESD) IEC 61000-
4-2
±6 kV contact
±8 kV air
±2, ±4, ±6KV
Contact
±2, ±4, ±8KV Air
Floors should be wood, concrete
or ceramic tile. If floors are covered with
synthetic material, the relative humidity should
be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1KV for input/
output lines
Not applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
Not applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on
power supply input
lines
IEC 61000-4-11
<5 % UT for 0,5
cycle
(>95 % dip in UT )
40 % UT for 5
cycles
(60 % dip in UT )
70 % UT or 25
cycles
(30 % dip in UT )
<5 % UT for 5 sec
(>95 % dip in UT )
Not applicable
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the handpiece requires continued operation
during power mains interruptions, it is
recommended that the handpiece be powered
from an uninterruptible power supply or a
battery.
The handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of
the handpiece should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
3 V
3 V/m
Portable and mobile RF communications equipment should
be used no closer to any part of the handpiece, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended sep aration distance
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,
a
should be less than the
compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, 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.
