inofab SPIROHOME User manual

SPIROHOME® FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME®
Revision Number
00
Revision Date
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Page
1 / 44
SPIROHOME®
ULTRASONIC SPIROMETER
The document will be signed after revision.
FUNCTION
DATED
SIGNED
Prepared by
Regulatory Affairs
Deniz SARP
Reviewed by
Quality Assurance
Ahmet Gökdere
Approved by
CEO
Merthan Öztürk
REVISION RECORD
REVISION
NUMBER
DATE
COMMENTS
SIGNED
00
24.02.2019
Initial Issue
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  www.spirohome.io  1/44

SPIROHOME® FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME®
Revision Number
00
Revision Date
--
Page
2 / 44
Spirohome® Personal
User Manual
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  www.spirohome.io  2/44

SPIROHOME® FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME®
Revision Number
00
Revision Date
--
Page
3 / 44
1.Preface
1.1 Spirohome® Personal user manual version history
Version Number
Publication Date
Description
Rev.00
24.02.2019
Initial version for market launch
This revision of the Spirohome®Personal user manual applies to Spirohome®Personal devices
with a serial number between S011900001-S011900150.
Version histories of all Spirohome®user manuals can be found on the Spirohome®website
www.spirohome.io.
For any queries relating to the revision history of the user manual or product, please contact
your Spirohome® dealer or manufacturer.
1.2 Intended use of the Spirohome® Personal
The Spirohome®Personal is a prescription device for diagnostic spirometry testing of adult and
pediatric patients over the age of 5 who have been diagnosed with a chronic pulmonary disease
including, but not limited to, asthma, chronic obstructive pulmonary disease and cystic fibrosis. It
is to be operated in the home setting by competent adult patients or caregivers of
patients.
1.3 About this user manual
This user manual should be read by users of the device prior to operating the Spirohome®
Personal. Store this user manual in a clean and easily accessible place for future reference.
1.4 Legal Information
Contents of the user manual may be subject to change. Please refer to the Spirohome®website
for the latest version of user manuals. No part of this manual may be reproduced without the
written permission from Inofab.
© İnofab Sağlık Teknolojileri A.Ş, Ankara, Turkey. All rights reserved.
Spirohome® is a registered trademarks of İnofab Sağlık Teknolojileri A.Ş.
Spiroway® s a registered trademarks of İnofab Sağlık Teknolojileri A.Ş.
Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
1.5 Electromagnetic Compatibility
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  www.spirohome.io  3/44

SPIROHOME® FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME®
Revision Number
00
Revision Date
--
Page
4 / 44
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Changes or modifications made to this equipment not expressly approved by Inofab Sağlık
Teknolojileri A.Ş. may void the FCC authorization to operate this equipment.
1.6 Product Disposal
This product should not be discarded as regular household waste but as electronic waste
according to in accordance with local regulations and returned to a collection point of recycling
electric and electronic devices.
Used batteries should be disposed of in designated battery recycling containers in accordance
with local laws and regulations
1.7 Manufacturer Information
İnofab Sağlık Teknolojileri A.Ş
ODTÜ Teknokent Silikon Blok
K:1 NO:15-A Ankara/Turkey
Tel: +90 312 988 0308
www.spirohome.io
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  www.spirohome.io  4/44

SPIROHOME® FDA DOSSIER
Document No
SUS-FDAD
Publication Date
24.02.2019
USER MANUAL - PERSONAL
SPIROHOME®
Revision Number
00
Revision Date
--
Page
5 / 44
Table of Contents
1. Preface
1.1 Spirohome® Personal user manual version history
1.2 Intended use of the Spirohome® Personal
1.3 About this user manual
1.4 Legal Information
1.5 Electromagnetic interference
1.6 Product disposal
1.7 Manufacturer Information
2. Safety Information
2.1 Safety warnings and precautions
2.2 Restrictions on use and contraindications
2.2 Signs and symbols
3. About the Spirohome® Personal
3.1 Product description
3.2 The Spirohome® Personal System
3.3 Orderable accessories
4. Cybersecurity
4.1 About cybersecurity and your Spirohome® Personal
4.2 Passwords on the Spirohome® Personal platform
4.3 Software Updates
4.4 Data back-ups
4.5 Security breaches
4.6 Lost or stolen devices
5. Spirohome® Personal and smart device connectivity
5.1 Connectivity of the Spirohome® Personal platform
6. Operating the device
6.1 How to use the Spirohome® Personal: An overview
6.1 Operating environment
6.2 Setting up your Spirohome® Personal
6.3 Device indicators
6.4 Technical features of the Spirohome® Personal
6.5 Troubleshooting and error messages
7. Spirometry with your Spirohome® Personal
7.1 How to perform a spirometry test
7.2 Spirometry parameters
7.3 Types of breathing maneuvers
7.4 Understanding test quality
8. Maintenance and Cleaning of your Spirohome® Personal
8.1 Cleaning and disinfection of the device
Spirohome® Personal User Manual  Rev.00 Feb 2019  İnofab Sağlık Teknolojileri A.Ş.
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