KaVo FS Ergo User And Installation Manual page 35

Flexible digital intraoral x-ray sensor
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Table 3: RF immunity of non-life-support equipment or system IEC 60601-1-2
Edition 4.0 2014-02
FS Ergo is suitable for use in the specified electromagnetic environment.
The purchaser or user of FS Ergo should assure that it is used in an
electromagnetic environment as described below:
Immunity
Test
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
*Field strengths from fixed transmitters, such as base stations for cellular telephones
and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast
cannot be estimated accurately. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be performed. If the
measured field strength exceeds the RF compliance level above, observe FS Ergo to
verify normal operation in each use location. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating FS Ergo.
Guidance for actions taken can be found from AAMI TIR 18:2010, Guidance on
electromagnetic compatibility of medical devices in healthcare facilities.
NOTICE! Precautions to take if the use location is near (e.g. less than 1,5 km
from) AM, FM or TV broadcast antennas.
**Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m.
The Recommended Separation Distances are listed in the next table.
NOTICE! These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects,
and people.
FS Ergo Sensor
IEC
Compliance
60601-1-2
Level
Test Level
3V 150kHz
3V 150kHz
to 80 MHz,
to 80 MHz,
6 V in ISM
6 V in ISM
and amateur
and amateur
radio bands
radio bands
between 0,15
between
MHz and 80
0,15 MHz
MHz according
and 80 MHz
to table
according
60601-1-2.
to table
Ed4. Table
60601-1-2.
5/8.
Ed4. Table
5/8.
10 V/m 80
10 V/m 80
MHz to 2,7
MHz to 2,7
GHz
GHz
Immunity
Immunity
to proximity
to proximity
fields from
fields from
RF wireless
RF wireless
communication
communication
equipment,
equipment,
levels
levels
according
according
to table
to table
60601-1-2
60601-1-2
ed4 table 9.
ed4 table 9.
Electromagnetic Environment
Portable and mobile RF communications
equipment are used no closer to any part
of the FS Ergo including cables, than
the recommended separation distance
calculated from the equation appropriate
for the frequency of the transmitter.
Recommended Separation Distance:
150kHz-80MHz
80MHz to 800 MHz
800 MHz to 2,7 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,* are
less than the compliance level in each
frequency range.**
Interference may occur in the vicinity
of equipment marked with the following
symbol:
7 Technical data
35

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