AcceleDent OPTIMA Mode D'emploi page 22

IMMUNITY Test IEC60601 Test
Level
Conducted RF IEC 6V Amateur
61000-4-6 0,15 MHz – 80 MHz
Enclosure
Radiated RF IEC
61000-4-3 10V/m
80% AM at 1 kHz
or risk frequency
80 MHz – 2700 MHz
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 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 AcceleDent Optima is
used exceeds the applicable RF compliance level above, the AcceleDent Optima should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating AcceleDent Optima.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
10.16 Material:
10.16.1. AcceleDent Optima is made of biocompatible materials. The
AcceleDent Optima Activator has been tested and verified to have less than
0.01% by mass of Latex proteins. The AcceleDent Optima Activator has been
tested and verified to have less than 0.01% by mass of DEHP.
Compliance Electromagnetic
Level Environment - Guidance
Portable and mobile RF communications
equipment should be used no
closer to any part of AcceleDent
Optima, including cables, than the
recommended
separation distance calculated from
the equation applicable to the
6 V frequency of the transmitter.
d=1.2√P
80 MHz to 800 MHz
d=2.3√P
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
Enclosure separation distance in meters (m).
10V/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:
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