SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
41 / 44
Table 1: Emission table for IEC 60601-1-2
Guidance and manufacturer’s declaration – electromagnetic emissions
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
environments.
Emission Test
Compliance
Electromagnetic environment -
guidance
RF emissions CISPR 11
Group 1
The Spirohome
®
battery-operated
devices use RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions CISPR 11
Class B
The Spirohome
®
devices are
suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic
purposes.
Harmonic emissions IEC
61000-3-2
Not applicable
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Not applicable
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
41/44
