SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
43 / 44
Guidance and manufacturer’s declaration – electromagnetic immunity
Spirohome
®
battery-operated spirometer devices are intended for use in the electromagnetic
environment specified below. Users of these devices should assure that it is used in such
environment.
Immunity test
standard
IEC 60601
test level
Compliance
level
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
NA
3 V/m 80 MHz
to 2.7 GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the Spirohome
®
devices
including cables, than the recommended
separation distance calculated from the
equation appropriate to the frequency of
the transmitter.
Recommend 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 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:
Spirohome
®
Personal User Manual Rev.00 Feb 2019 İnofab Sağlık Teknolojileri A.Ş.
ODTÜ Teknokent / Silikon Blok K:1 No:15-A Çankaya / Ankara / Turkiye
.io
43/44
