Poldent Endostar, Instructions For Use Manual, Page: 36 / 40

35 Instructions for Use 2019-03-20
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below.
The customer or the user of this device 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
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
±2 kV, ±4 kV, ±6 kV, ±8
kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with syn-
thetic material, the relative
humidity should be at least
30%.
Electrical fast
transients/bursts
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power supply
lines
±1 kV for input/output
lines
Mains power quality should
be that of a typical com-
mercial or hospital environ-
ment.
Surge
*1
IEC 61000-4-5
AC/DC power
±0.5 kV, ±1 kV line(s) to
line(s)
±0.5 kV, ±1 kV, ±2 kV line(s)
to earth
Signal input/output
±2 kV line(s) to earth
AC/DC power
±0.5 kV, ±1 kV line(s) to
line(s)
±0.5 kV, ±1 kV, ±2 kV line(s)
to earth
Signal input/output
±2 kV line(s) to earth
Mains power quality should
be that of a typical com-
mercial or hospital environ-
ment.
Voltage dips, short
interruptions and
voltage variations on
power supply lines
*1
IEC 61000-4-11
dips
0%
U
T
: 0.5 cycle (at 0,
45, 90, 135, 180, 225,
270, 315°)
0%
U
T
: 1 cycle (at 0°)
70%
U
T
: 25/30 cycles (at
0°)
25 (50 Hz)/30 (60 Hz)
short interruptions
0%
U
T
: 250/300 cycles
250 (50 Hz)/300 (60
Hz)
dips
0%
U
T
: 0.5 cycle (at 0,
45, 90, 135, 180, 225,
270, 315°)
0%
U
T
: 1 cycle (at 0°)
70%
U
T
: 25/30 cycles (at
0°)
25 (50 Hz)/30 (60 Hz)
short interruptions
0%
U
T
: 250/300 cycles
250 (50 Hz)/300 (60
Hz)
Mains power quality should
be that of a typical commer-
cial or hospital environment.
If user of this device requires
continued operation during
power mains interruptions,
it is recommended that this
device be powered from an
uninterruptible power sup-
ply or a battery.
Power frequency
(50/60 Hz) mag-
netic field
IEC 61000-4-8
30 A/m (r.m.s.)
50 Hz or 60 Hz
30 A/m (r.m.s.)
50 Hz or 60 Hz
Power frequency magnetic
field should be at levels
characteristic of a typical
location in a typical com-
mercial or hospital environ-
ment.
NOTE 1:
U
T
is the a.c. mains voltage prior to application of the test level.
NOTE 2: r.m.s.: root mean square
Electromagnetic Disturbances (EMD)