Emc Declaration - VISIOMED bewell connect MyScale Manual De Usuario

EMC DECLARATION

GUIDANCE AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC IMMUNITY
THE BW-SC2 IS INTENDED FOR USE IN THE ELECTROMAGNETIC ENVIRONMENT SPECIFIED BELOW. THE
CUSTOMER OR THE USER OF THE BW-SC2 SHOULD ENSURE THAT IT IS USED IN SUCH AN ENVIRONMENT.
Immunity test IEC 60601 test
level
Electrostatic ±6 kV contact
discharge (ESD) ±8 kV air
IEC 61000-4-2
Electrical fast ±2 kV for pow-
er supply lines
transient/burst
±1 kV for input/
IEC 61000-4-4
output lines
Surge ±1 kV differen-
tial mode
IEC 61000-4-5
±2 kV common
mode
Voltage dips, short <5 % Ur (>95
interruptions and % dip in Ur) for
voltage variations 0,5 cycles
on power supply
input lines
40 % Ur (60 %
dip in Ur) for 5
IEC 61000-4-11 cycles
70 % Ur (30 %
dip in Ur) for 25
cycles
<5 % Ur (>95
% dip in Ur) for
5 sec
Power frequency 3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
66 BewellConnect - BW-SC2 - User Manual - 112015
Compliance Electromagnetic environment –
level guidance
±6 kV contact Floors should be wood, concrete
or ceramic tile. If floors are covered
±8 kV air
with synthetic material, the relative
humidity should be at least 30 %.
±2 kV for pow- Mains power quality should be that
er supply lines of a typical commercial or hospital
environment.
±1 kV for input/
output lines
±1 kV differen- Mains power quality should be that
tial mode of a typical commercial or hospital
±2 kV common environment.
mode
<5 % Ur (>95 Mains power quality should be that
% dip in Ur) for of a typical commercial or hospital
0,5 cycles environment. If the user of the BW-
SC2 requires continued operation
during power mains interruptions,
40 % Ur (60 %
it is recommended that the BW-SC2
dip in Ur) for 5
be powered from an uninterruptible
cycles
power supply or a battery.
70 % Ur (30 %
dip in Ur) for 25
cycles
<5 % Ur (>95
% dip in Ur) for
5 sec
3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commer-
cial or hospital environment.
EMC data
Guidance and manufacturer's declaration - electromagnetic immunity - for
equipment and system that are not life-supporting. The model BW-SC2 is intended
for use in the electromagnetic environment specified below. The customer or the user
of the model BW-SC2 should assure that it is used in such an environment.
Immunity EN 60601 Compliance
test test level level
Portable and mobile RF communications equipment should
3 Vrms
Conducted be used no closer to any part of the Infared Thermometer type
150 kHz
RF EN N/A BW-SC2, including cables, than the recommended separation dis-
to 80
61000-4-6 tance calculated from the equation applicable to the frequency of
MHz
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
3 V/m
Radiated
watts (W) according to the transmitter manufacturer and d is the
80 MHz
RF EN 3 V/m
recommended separation distance in meters (m).
to 2.5
61000-4-3
Field strengths from fixed RF transmitters, as determined by an
GHz
electromagnetic site survey, should be less than the compliance
level in each frequency range. b Interference may occur in the vi-
cinity 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 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 consid-
ered. If the measured field strength in the location in which the BW-SC2 is used exceeds the
applicable RF compliance level above, the Medical BW-SC2 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be nec-
essary, such as reorienting or relocating the BW-SC2.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]
V/m.
BewellConnect - BW-SC2 - User Manual - 112015
Electromagnetic
environment - guidance
67