Monitored Therapeutics GoSpiro Spirometer - Electromagnetic Emissions Guidance; Intended Electromagnetic Environment; Electromagnetic Emissions Tests; RF Emissions Compliance (CISPR 11)

Monitored Therapeutics, Inc. © Copyright 2020 19 P/N 45-50035 Rev. K, 2020-10-21
20. ELECTROMAGNETIC COMPATIBILITY
Guidance and manufacturer’s declaration – electromagnetic emissions
The GoSpiro Spirometer is intended for use in the electromagnetic environment specified below.
The customer or the user of the GoSpiro Spirometer should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The GoSpiro Spirometer uses RF energy only for its internal function. Therefore, its
RF emissions are very low and not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The GoSpiro Spirometer 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 61000-3-2
Class B
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The GoSpiro is intended for use in the electromagnetic environment specified below. The customer or user of the
GoSpiro should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2:2014 (4
th
Edition) test level
Compliance level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
± 8 kV contact
± 2, 4, 8 and 15 kV air
± 8 kV contact
± 2,4, 8 and 15 kV air
The relative humidity should be at least 5 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply
lines
100 kHz PRR
± 2 kV for power supply
lines
100 kHz PRR
Main power quality should be that of a typical
home, commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to
earth
± 0.5 and 1 kV line(s) to
line(s)
± 0.5, 1 and 2 kV line(s) to
earth
Main power quality should be that of a typical
home, commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
0 % U
T
; 0,5 cycle, @ 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315°
0% U
T
; 1 cycle and 70%
UT; 25/30 cycles,@ 0°
0 % U
T
; 250/300 cycle
0 % U
T
; 0,5 cycle, @ 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315°
0% U
T
; 1 cycle and 70%
UT; 25/30 cycles,@ 0°
0 % U
T
; 250/300 cycle
Main power quality should be that of a typical
home, commercial or hospital environment.
If the user of the GoSpiro Spirometer requires
continuous ability to charge the GoSpiro during
power mains interruptions, it is recommended
that the charger be powered from an
uninterruptible power supply.
Power frequency
(50/60 Hz) Magnetic
field IEC 61000-4-8
30 A/m
30 A/m
Keep the GoSpiro away from sources of high
levels of power line magnetic fields (in excess of
30 A/m) to reduce the likelihood of interference.
NOTE U
T
is the AC mains voltage prior to application of the test level