SPIROHOME
®
FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME
®
Revision Number
00
Revision Date
--
Page
9 / 44
The spirometry tests should only be performed by users who do not experience any shortness
of breath and are in good health for performing a lung function test. Test results of patients who
do not meet these conditions may not be reliable.
Failure to perform the specific breathing maneuver of a particular spirometry test correctly may
lead to inaccurate and/or unacceptable results. Refer to the Breathing Maneuvers section of this
user manual for more information.
Some medical conditions may pose a danger to you or affect the validity of spirometry
performance and results. These conditions include, but are not limited to, the following: acute
disorders (e.g. active lung infection), illness or condition that may cause serious consequences
if aggravated by forced expiration (e.g. dissecting / unstable aortic aneurysm, recent/current
pneumothorax, recent surgery including ophthalmic, thoracic, abdominal or cerebral aneurysms,
unstable angina), recent myocardial infarction (within one month), recent pulmonary embolism,
undiagnosed chest conditions (e.g. haemoptysis of unknown origin), nausea, vomiting, severe
respiratory distress, physical limitations or cognitive impairment or dementia.
If you have or
suspect having any of the conditions above, consult your healthcare professional before
using the
Spirohome
®
Personal
.
2.2 Signs and symbols
Please note the following signs and symbols provided for the safe use and storage of your
Spirohome
®
Personal.
Markings
Descriptions
“Manufacturer”
The name and the address of the manufacturer is adjacent to the symbol.
‘FCC ID’
Unique identifier given by the Federal Communications Commission
‘Rx Only’
Prescription-only device
Disposal in compliance with Waste Electrical and Electronic Equipment Directive
Temperature limit
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
9/44
