Introduction; Intended Use; Usage Environment; Restrictions On Use - MIR Smart One Bedienungsanleitung

1. INTRODUCTION

1.1

Intended use

SMART ONE is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and
FEV1 (Forced Expiratory Volume in one second). The device is designed for adult and
paediatric subjects.
SMART ONE is indicated for monitoring asthma, COPD and other respiratory diseases.
1.1.1

Usage environment

SMART ONE is designed to be used in the home.
1.1.2

Restrictions on Use

Analysis of the test results alone will not be enough to diagnose your clinical condition – you
will need a medical examination which will take your clinical history into account as well as
any other tests recommended by the doctor.
Diagnosis and appropriate treatments are to be given only by a qualified doctor.
The device is intended for use by one person only. If more than one person wishes to use the
device, one user's measurements must not be attributed to another. If another person
intends to use the device permanently, the previous user data must be erased from the
memory and the new user's details data (date of birth, origin, weight, height, sex) must be
entered.
If you wish to use the device when it has already been used by another person, make sure to
disinfect the mouthpiece and turbine, as explained in the Maintenance section.
Rev 2.0 User Manual
Smart One
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