Coltene MicroMega Dual-move Instrucciones página 12

Rated power frequency
magnetic fi eld IEC
61000-4-8
Note: UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz
Immunity test IEC 60601
test level
Conducted RF - 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz
Radiated RF - 3 V/m
IEC 61000-4-3 80 MHz to
2.7 GHz
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 be absorption and
refl ection from structures, objects and people.
a Field strengths from fi xed 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 fi xed RF transmitters, an electromagnetic site survey
should be considered. If the measured fi eld strength in the location in which the Dual Move is used exceeds the
applicable RF compliance level above, the Dual Move should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting of relocating the Dual
Move.
** Over the frequency range 150 kHz to 80MHz, fi eld strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the medical device.
Nowadays, many RF wireless equipments have being used in various healthcare locations where medical equipment and/or systems are used. When they are
used in close proximity to medical equipment and/or systems, the medical equipment and/or systems' basic safety and essential performance may be
affected. The Dual Move has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2020. The
customer and/or user should help keep a minimum distance between RF wireless communications equipments and the Dual Move as recommended below.
Rated maximum output
power of transmitter
W
0.01
0.1
1
10
100
12
3 A/m 5OHz or 60Hz
Compliance Electromagnetic environment - guidance
level
3V Portable and mobile RF communications equipment should be used no closer to any part of
the medical device, including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2√
P
d=1.2√ 800 MHz ~ 800 MHz
P
d=2.3√ 800 MHz ~ 2.5 GHz
3.5 V/m P
Where is the maximum output power rating of the transmitter in watts (W) according to the
P
transmitter manufacturer and d is the recommended separation distance in meters (m). Field
strengths from fi xed RF transmitters, as determined by an electromagnetic site survey, should be
less than the compliance level in each frequency range.**
Interference may occur in the vicinity of equipment marked with the following symbol:
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d=1.2√
P
0.12
0.38
1.2
3.8
12
3 A/m 50Hz or 60Hz
Power frequency magnetic fi eld
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
80 MHz to 800 MHz
d=1.2√
P
0.12
0.38
1.2
3.8
12
800 MHz to 2.5 GHz
d=2.3√
P
0.23
0.73
2.3
7.3
23