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Guidance and manufacturer's declaration - electromagnetic immunity
The ENDO-MATE DT is intended for use in the electromagnetic environment specified below. The customer or the user of the ENDO-MATE DT should assure that it is
used in such an environment.
NOTE:
Ut is the a.c. mains voltage prior to application of the test level.
Immunity test
IEC60601 test level
Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC61000-4-2
Electrical fast transient/burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC61000-4-11
Power frequency (50/60Hz)
magnetic field
IEC61000-4-8
±(2,4) 6 kV contact
±(2,4) 8 kV air
±2kV for power supply lines
±1kV for input/output
±1kV line(s) to line(s)
±2kV line(s) to earth
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
3 A/m
Compliance level
±(2,4) 6 kV contact
±(2,4) 8 kV air
±2kV for power supply lines
±1kV for input/output
±1kV line(s) to line(s)
±2kV line(s) to earth
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
3 A/m
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Mains power quality should be that of a typical commercial
or hospital environment.
Mains power quality should be that of a typical commercial
or hospital environment.
Mains power quality should be that of a typical commercial
or hospital environment. If the user of the ENDO-MATE DT
requires continued operation during power mains
interruptions, it is recommended that the ENDO-MATE DT be
powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Guidance and manufacturer's declaration - electromagnetic immunity
The ENDO-MATE DT is intended for use in the electromagnetic environment specified below. The customer or the user of the ENDO-MATE DT should assure that it is
used in such an environment.
NOTE 1
At 80MHz and 800MHz, 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 mobiles 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 ENDO-MATE DT is used exceeds the applicable RF
compliance level above, the ENDO-MATE DT should be observed to verity normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the ENDO-MATE DT.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Immunity test
IEC60601 test level
Electromagnetic environment - guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3Vrms
150 kHz to 80MHz
3V/m
80MHz to 2.5 GHz
Compliance level
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used
no closer to any part of the ENDO-MATE DT, 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
P
80MHz to 800MHz
d
= 2.3
P
800MHz to 2.5GHz
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 metres (m).
Field 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:
Complies with
Maximum length
Cables and accessories
RF emissions, CISPR11,
Harmonic emissions,
Voltage fluctuations/ flicker emission
Electrostatic discharge (ESD)
Surge
Voltage dips, short interruptions and voltage variations on power supply input lines
Power frequency (50/60Hz) magnetic field
Conducted RF
Radiated RF
1.5 m
2.5 m
Plug side : 1.8m
Unit side : 1.8m
Motor Handpiece cord
Foot Controler cord
AC Adapter
Class B/ Group 1
IEC61000-3-2, Class A
IEC61000-3-3
IEC61000-4-2
IEC61000-4-5
IEC61000-4-11
IEC61000-4-8
IEC61000-4-6
IEC61000-4-3
150kHz to 80MHz
d
=1.2
P
Recommended separation distances between portable and mobile RF communications equipment and the ENDO-MATE DT
The ENDO-MATE DT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
ENDO-MATE DT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the ENDO-MATE DT as recommended below, according to the maximum output power of the communications equipment.
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.
Rated maximum output power of transmitter
W
800MHz to 2.5GHz
d
=2.3
P
80MHz to 800MHz
d
=1.2
P
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.
Separation distance according to frequency of transmitter
m
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
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