17
7.
Electromagnetic Compatibility (EMC) Tables
All medical electronic devices must conform to the requirements of IEC 60601-1-2.
Precautions, adherences to the EMC guideline information provided in this manual and
verification of all medical devices in simultaneous operation are required to ensure the
electromagnetic compatibility and co-existence of all other medical devices.
n
Guidance and manufacturer’s declaration
–
electromagnetic immunity
The Dental Root Canal Orifices Detector is intended for use in the electromagnetic environment specified below.
The customer or the user of The Dental Root Canal Orifices Detector should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment
–
guidance
Radiated,
Radio
-
frequency,
electromagnetic field
IEC 61000
-
4
-
3:2010
80MHz
-
2.7GHz
3V/m
80%, 1kHz AM
3V/m,
9V/m,
27V/m, 28V/m
Portable and mobile RF communications equipment should be
used no closer to any part of
The Dental Root Canal Orifices
Detector
, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d =
1,2
d =
1,2
80 MHz to 800 MHz
d =
2,3
800 MHz to 2,5 GHz
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 meters (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:
Proximity fields from RF
wireless communications
equipment
IEC 61000
-
4
-
3:2010
PASS
Immunity to conducted
disturbances, induced by
radio
-
frequency fields
IEC 61000
-
4
-
6:2013
0.15
-
80MHz
3V, 6V
0.15
-
80MHz
3V, 6V
NOTE 1 Applicable Limits: For radiated emissions at frequencies up to 1GHz (Class A, Group 1/2) & up to 1GHz (Class B, Group
1/2)
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 mobile 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 Dental Root Canal Orifices Detector
is used exceeds the applicable RF
compliance level above,
The Dental Root Canal Orifices Detector
should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
The Dental Root
Canal Orifices Detector
.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration
–
electromagnetic immunity
The Dental Root Canal Orifices Detector
is intended for use in the electromagnetic environment specified below. The
customer or the user of
The Dental Root Canal Orifices Detector
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
–
guidance
