MIR SMARTONE - Device Functioning and Testing Procedures; PC Connection and Spirometry Testing; Spirometry Test Interpretation

SmartOne
Page 10 of 17
Rev.0.1
User manual
Humidity: MIN 10% RH; MAX 95%RH
Compliance with standards
Electrical Safety Standard IEC 60601-1
EMC Standard IEC 60601-1-2
Type of electrical protection
Class II
Grade of electrical protection
BF
Grade of protection against water
ingress
IPX0
Level of safety in the presence of
inflammable anaesthetic gas, oxygen
or nitrogen
Not suitable
Conditions of use
Device for continuous use
Essential performances (compliant
with EN 60601-1: 2007)
Accuracy in spirometry parameters measuring, compliant with standard ATS
2. FUNCTIONING OF THE Smart One
®
2.1 Connection to PC
WARNING
Before connecting Smart One
®
to a PC, the winspiroPro software must be installed on the PC in order to interface it with
the device.
To make the connection, performe a Bluetooth pairing between device and PC.
To control the proper connection between the device and the PC check that the led on the device is lit.
2.2 Using the Smart One
®
For correct use of the device and for setup of data required for the interpretation of the results (initial setup, turbine calibration,
patient data management, viewing previous data and interpretation of results) see the winspiroPro software manual.
2.3 Spirometry Testing
WARNING
The device must only be used by qualified personnel with complete knowledge of spirometry; this is important for the
correct execution of the tests, for the acceptability of measured parameters as well as for the correct interpretation of
results.
For correctly carrying out a spirometry test, it is strongly recommended to carefully follow the instructions as described below.
 Insert the mouthpiece supplied into the hollow part of the turbine by at least 0.5 cm.
 Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils.
 Hold Smart One
®
in one hand as you would a cell phone. The side with the ID label should be in the hand of the user.
 Insert the mouthpiece well into the mouth beyond the teeth, being carefully to ensure that air cannot escape from the sides of the
mouth.
 It is suggested to make testing in a standing position and during an expiration lean forward, in order to help the expiratory action
with a compression of the abdomen.
WARNING
Please note it is indispensable for an accurate spirometry that all air must be expired from lungs. It is important to stress
that the disposable mouthpiece and turbine must be changed at the end of each test.
After 6 seconds from the initial forced expiratory Smart One
®
emits a continuous beep,. This is useful to the doctor to understand
if the patient has reached the minimum expiry time pursuant to the requirements as set forth by the major international associations
of pneumology.
2.4 Spirometry test interpretation
The interpretation of these indices %, according to the ATS standards, generates a series of messages which correspond to possible
levels of obstruction or restriction plus one level of normal spirometry, as shown in the following table: