Guidelines And Manufacturer's Statement - Electromagnetic Immunity - KaVo Key Laser III 1243 Instructions For Use Manual

Instructions for use KEY Laser III 1243
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2 Safety 2.5 Electromagnetic Transmissions
Immunity tests
Conducted HF distur‐
bances according to
IEC 61000-4-6
Radiated HF disturban‐
ces according to IEC
61000-4-3
2.5.3 Guidelines and manufacturer's statement - Electromagnetic im‐
munity
The KEY Laser 1243 is for use in an environment like the one cited below. The
operator of the KEY Laser 1243 must ensure that it is operated in such an environ‐
ment.
IEC 60601 test level
3 V
eff
150 kHz to 80 MHz
Outside ISM bands
a
3 V/m
80 MHz to 2.5 GHz
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not be applicable in every case. The spread of
electromagnetic waves is absorbed and reflected by buildings, objects and people.
The ISM frequency bands (for industrial, scientific and medical applications) bet‐
a
ween 150 kHz 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 conformance levels in the ISM frequency bands between 150 kHz and 80 MHz
b
and the frequency range of 80 MHz and 2.5 GHz are intended to reduce the pro‐
bability that mobile and portable communications equipment will produce distur‐
bances when they are unintentionally brought near the patient. For this reason, the
additional factor of 10/3 is used when calculating the recommended safe distances
within these frequency ranges.
The field strength of stationary transmitters such as base stations of mobile tele‐
c
phones and land mobile radio devices, amateur radio stations, AM and FM, radio
and television broadcasters cannot be theoretically predetermined. To determine
the electromagnetic environment of stationary transmitters, a study of the location
should be considered. When the measured field strength at the site where the KEY
Laser 1243 is used exceeds the above conformance level, the KEY Laser 1243
should be monitored to demonstrate proper function. When unusual performance
features are observed, additional measures may be necessary such as realigning
or moving the KEY Laser 1243.
Conformance level
3 V
eff
10 V/m
22/99
Electromagnetic environment - gui‐
delines
Portable and mobile radio devices
should not be used closer to the
KEY Laser 1243 (and its electrical
lines) than the recommenced safe
distance calculated using the equ‐
ation for the transmission frequen‐
cy.
Recommended safe distance:
d = 1.17
P
d = 0.35 for 80 MHz to 800 MHz
P
d = 0.70 for 800 MHz to 2.5 GHz
P
with P as the maximum rated power
of the transmitter in Watts (W) ac‐
cording to the transmitter manufac‐
turer, and d as the recommended
safe distance in meters (m).
The field strength of stationary ra‐
b
dio transmitters should be less than
the conformance level at all fre‐
quencies in an on-site check
Disturbances are possible close to
d
devices that have the following
symbol.
.
c