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Clevemed SleepView - Appendix A: Electromagnetic Immunity and Emissions; Electromagnetic Immunity Guidance

Clevemed SleepView
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SLEEPVIEW USER MANUAL
33
Appendix A: Electromagnetic Immunity and Emissions
Guidance and manufacturer’s declaration – electromagnetic immunity
The SleepView System is intended for use in the electromagnetic environment specified below. The customer or the user of the
SleepView System should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete, or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply lines
±1kV for input/output lines
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV line(s) to line(s)
±2kV line(s) to earth
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<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 s
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of the SleepView System requires continued
operation during power mains interruptions, it is
recommended that the SleepView System be powered
from an uninterruptible power supply or a battery.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the SleepView
system, 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 80 MHz to 800 MHz
𝑑 = 2.3 √𝑃 800 MHz to 2.3 GHz
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 meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,
a
should be less than
the compliance level in each frequency range.
b
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 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 considered. If the measured field strength in the
location in which the SleepView system is used exceeds the applicable RF compliance level above, the SleepView system should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the SleepView system.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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