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Idiomas disponibles
Electromagnetic immunity
Immunity test
IEC 60601 test level
Electrostatic discharge (ESD)
±6 kV contact
IEC 61000-4-2
±8 kV air
Electrical fast transients/bursts
±2 kV for power supply lines
IEC 61000-4-4
±1 kV for input/output lines
Surge
±1 kV line(s) to line(s)
IEC 61000-4-5
±2 kV line(s) to earth
Voltage dips, short interruptions
<5% UT (>95% dip in UT) for 0.5 cycle
and voltage variations on power
40% UT (60% dip in UT) for 5 cycles
supply lines
70% UT (30% dip in UT) for 25 cycles
IEC 61000-4-11
<5% UT (>95% dip in UT) for 5s
Power frequency (50/60 Hz)
3 A/m
magnetic field IEC 61000-4-8
U
is the AC mains voltage prior to application of the test level. EUT is the Unit Under Test
T
Immunity test IEC 60601
Compliance
Electromagnetic environment - guidance
test level
level
Conducted RF -
3 Vrms
3V
Portable and mobile RF communications equipment should be used no closer to any part of
IEC 61000-4-6
150 kHz to
the medical device, including cables, than the recommended separation distance calculated
80 MHz
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2√
d=1.2√
d=2.3√
Radiated RF -
3 V/m
3.5 V/m
Where
IEC 61000-4-3
80 MHz to
transmitter manufacturer and d is the recommended separation distance in meters (m). Field
2.5 GHz
strengths from fixed 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:
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
reflection from structures, objects and people.
a
Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field 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
10
Compliance level
Electromagnetic environment -
guidance
±2, 4, 6 kV contact
Floors should be in wood, concrete or
±2, 4, 8 kV air
ceramic tile. If covered by synthetic
material, the relative humidity should
be at least 30 %.
Not applicable
The test is applicable since the EUT
Not applicable
does not have AC/DC power plugs
and signal / interconnecting cable
longer than 3m.
Not applicable
The test is not applicable since the
Not applicable
EUT does not have AC power plug.
Not applicable
The test is not applicable since the
Not applicable
EUT does not have AC power plug.
Not applicable
Not applicable
3 A/m
Power frequency magnetic field
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
P
800 MHz ~ 800 MHz
P
800 MHz ~ 2.5 GHz
P
is the maximum output power rating of the transmitter in watts (W) according to the
P
performance is observed, additional measures may be necessary, such as reorienting of relocating the Dual
Move.
** Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the medical device.
The medical device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the medical device can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the medical device as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter (m)
power of transmitter
150 kHz to 80 MHz
W
d=1.2√
P
0.01
0.12
0.1
0.38
1
1.2
10
3.8
100
12
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: at 80 MHz and 800 MHz, the separation distance for 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.
17. Warranty
Inspections
and
repairs
must
only
be
Your product is an accurate medical device, produced under maximum quality and test conditions.
To ensure an individualized follow-up and traceability of your product, please complete the warranty
registration
on-line
on
www.micro-mega.com
activate the after-sales procedures for your device so that MICRO-MEGA can give you full satisfaction.
MICRO-MEGA guarantees the battery for one year, the motor handpiece and contra-angle for two years against any
hidden manufacturing defect, excluding faults due to improper use, inappropriate maintenance, accidental damage
(fall, impact, etc.), attempted intervention or repairs by personnel not approved by MICRO-MEGA, attempted product
modification.
18. Statement
Non-contractual pictures. MICRO-MEGA reserves the right to modify the characteristics of its product without prior notice.
Distributed by MICRO-MEGA
5-12, rue du Tunnel 25006
Besançon Cedex - France
Berwin Industry Ltd. 419,
Harborne Road, Edgbaston,
Birmingham, B153LB – UK
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d=1.2√
d=2.3√
P
P
0.12
0.23
0.38
0.73
1.2
2.3
3.8
7.3
12
23
carried
out
by
MICRO-MEGA
or
an
approved
website
within
10
days
of
your
purchase.
Manufactured by Changzhou Eighteeth Medical
Technology Co., Ltd
No. 99 Qingyang Road Xuejia County, Xinbei
District, Changzhou City, 213000, Jiangsu - China
Year of CE marking: 2017
partner.
This
will
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