Operation 2018-10-21
Page30
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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V
ISM
(c)
/ amateur radio
frequency band: 6 V
150 kHz to 80 MHz
10 V/m
80 MHz to 2.7 GHz
27 V/m
385 MHz
28 V/m
450 MHz
9 V/m
710, 745, 780 MHz
28 V/m
810, 870, 930, MHz
28 V/m
1720, 1845, 1970 MHz
28 V/m
2450 MHz
9 V/m
5240, 5500, 5785 MHz
3 V
ISM
(c)
/ amateur radio
frequency band: 6 V
150 kHz to 80 MHz
10 V/m
80 MHz to 2.7 GHz
27 V/m
385 MHz
28 V/m
450 MHz
9 V/m
710, 745, 780 MHz
28 V/m
810, 870, 930, MHz
28 V/m
1720, 1845, 1970 MHz
28 V/m
2450 MHz
9 V/m
5240, 5500, 5785 MHz
Portable and mobile RF communications
equipment should be used no closer to any
part of this device, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distances
d
=
1.2
√
P
150 kHz to 80 MHz
d
=
0.4
√
P
80 MHz to 800 MHz
d
=
0.7
√
P
800 MHz to 2.7 GHz
d
=
√
P
Portable wireless RF
communication
equipment
Where
P
is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer,
E
is the compliance level in V/m and
d
is
the recommended separation distance in
meters (m).
Field strengths from field 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.
(a)
Field strengths from fixed transmitters, such as base stations for ratio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated 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 this device is used exceeds the applicable RF compliance level above, this device should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting of relocating this device.
(b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
(c)
The ISM (Industrial, Scientific and Medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz
to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7
MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89
MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
Essential Performance
None
Cable List
No.
Interface(s):
Max. Cable Length, Shielding
Cable Classification
1.
AC Power Cable (TR-EX)
1.5 m, Un-shielded
AC Power Line
2.
DC Power Cable (TR-EX)
2.0 m, Un-shielded
DC Power Line
3.
Handpiece Cord (TR-EX)
1.5 m, Un-shielded
Signal Line (Patient-Coupled cable)
4.
Foot Pedal Cable (TR-EX)
1.9 m, Un-shielded
Signal Line
5.
Probe Cord (RCM-EX)
1.6 m, Un-shielded
Signal Line (Patient-Coupled cable)
6
E
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