User's Manual

SmartOne
Page 8 of 17
Rev.0.1
User manual
The main features of this multipurpose Smart One® make it is easy to use and versatile.
Spirometry function
Smart One
®
calculates up to 30 functional respiratory parameters, as well as the parameter comparison after the administration of
a drug (PRE/POST) for a bronchodilator test or for a bronchial challenge test. A comparison of data is made between POST
(after-drug) and PRE (before drug administration). The Pre test data relates to percentage variations between the measured results
and the predicted values based on the anthropometric data inserted.
The flow and volume measurement sensor is a digital turbine, based on the infrared interruption principal, which ensures accuracy
in time as required from a professional device.
The special features of this kind of sensor are listed below:
 Accurate measurement even at very low flow rates (end of expiration)
 Not affected by gas humidity nor density
 Shockproof and unbreakable
 Inexpensive to replace.
The two versions of the turbine flow measurement sensors, used on Smart One
®
(single-patient disposable or reusable), ensure
high precision in measurements and have the great advantage of requiring no periodic calibration (however, the turbines can be
calibrated if required by the doctor).
REUSEABLE TURBINE
In order to maintain the characteristics of the turbines the following precautions must be closely observed:
 for the single-patient disposable turbine: they must always be substituted between patients.
 for the reusable turbine: always clean the turbine between patients, to ensure the maximum level of hygiene and safety for the
patient.
For a correct interpretation of a spirometry test, the measured values must be compared either to the so-called normal or
predicted values which are calculated from the anthropometric details of the patient or, alternatively, to the personal best values
from the clinical history of the subject.
The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects.
Smart One
®
is connected to a PC trough a USB port. Data measured by Smart One
®
are transferred to the PC in real-time. The
Windows “winspiroPro” software allows to view the spirometric test results (flow/volume curves, spirometry parameters) plus the
related subject detail.
The data measured by Smart One
®
and arranged by the software are available for interpretation by specialised personnel.
The software gives an interpretation of each spirometry test by assigning a “traffic light” code and by comparing the previous values
of the same subject or the reference values of the subject’s group. For further details see the online manual of the WinSpiroPro
Software.
Smart One
®
is able to make FVC and calculates an index of test acceptability (quality control) plus reproducibility of the
spirometry tests carried out. The automatic test interpretation follows the latest 11 level ATS (American Thoracic Society)
classification. Each test can be repeated as required. The best parameters are always available for review. The normal (predicted)
values can be selected from several normal “sets”. For example, within the European Union the majority of doctors use the ERS
(European Respiratory Society) predicted values. For the configuration of parameters and storing tests, see the online manual of the
WinSpiroPro Software.
1.6 Technical features
There follows a comprehensive description of the main features of the device.
1.6.1 Features of the spirometer