SpiroConnect Operators Manual
MedChip Solutions Ltd.
Page 26 of 31
001.105.GBR Issue 1.12
Emissions test
Compliance
Electromagnetic environment
– guidance
RF emissions
CISPR 11
Group 1
The SpiroConnect must emit electromagnetic energy in order to perform
its intended function. Nearby electronic equipment may be affected.
RF emissions
CISPR 11
Class B
The SpiroConnect is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-
voltage power supply networks that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-3
Not applicable
Voltage fluctuations/flicker
emissions
Not applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
The SpiroConnect is intended for use in the electromagnetic environment specified below. The customer or user of the
SpiroConnect 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
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV 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
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Not applicable
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not applicable
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
<5%
U
T
(>95%dip
in
U
T
for 0.5 cycle
40%
U
T
(60% dip
in
U
T
) for 5 cycles
70% (30% dip in
U
T
) for 25 cycles.
<5% (>95% dip in
U
T
) for 5 s
Not applicable
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.
NOTE
U
T
is the a.c. mains voltage prior to application of the test level
Guidance and manufacturer’s declaration – electromagnetic immunity
The SpiroConnect is intended for use in the electromagnetic environment specified below. The customer or user of the
SpiroConnect should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V rms
3 V/m
3 V rms
3 V/m
Portable and mobile RF communications equipment should be used no
closer to any part of the SpiroConnect, 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 2,5 GHz
where
P
is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacture and d is the recommended
separation distance in metres (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 SpiroConnect is used exceeds the applicable RF
compliance level above, the SpiroConnect should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the SpiroConnect.
