Steiss UTS, User Manual

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10. EMC - Related Notification
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Manufacturer’s declaration – electromagnetic immunity
The Steiss™ Universal Therapy System (UTS) is intended for use in the electromagnetic environment (for home healthcare)
specified below. The customer or the user of the Steiss™ Universal Therapy System (UTS) should assure that is used in
such and environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnectic
environment - guidance (home healthcare and
professional healthcare environment).
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
3 Vrms:
0,15 MHz – 80
MHz
6 Vrms:
in ISM and
amateur
radio bands
between
0,15 MHz and
80 MHz
80 % AM at 1
kHz
10 V/m
80 MHz – 2,7
GHz
80 % AM at 1
kHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the Steiss™ Universal Therapy System
(UTS) , 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 = 1,2 √P 800 MHz to 2,5 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
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:
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.
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 M31 Handset (HS-BE), M31 Handset (HS-NBE) is
used exceeds the applicable RF compliance level above, the M31 Handset (HS-BE), M31 Handset (HS-NBE) should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the M31 Handset (HS-BE), M31 Handset (HS-NBE).
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
a)
b)