1.4.1 Identification label
The label shows:
Serial number of the device
Product name
Name and address of the manufacturer
Electrical safety symbol
Warning symbol for the WEEE Directive
Mark of conformity with the Medical Device Directive
1.4.2 Electrical safety symbol
In accordance with IEC 60601-1 this product and its component parts are of type BF and therefore protected against the hazards of direct and indirect contact with electricity.
1.4.3 Warning symbol for the WEEE Directive
This symbol is laid down in the 2002/96/EEC regarding the waste of electrical and electronic equipment (WEEE). At the end of its useful life this device must not be disposed of as normal domestic waste. Instead it must be delivered to a WEEE authorised collection centre.
As an alternative, the device may be returned without charge to the dealer or distributor, when it is replaced by another equivalent device.
Due to the construction materials used for the device, disposing it as a normal waste product could cause harm to the environment and/or health.
Failure to observe these regulations can lead to prosecution.
1.4.4 Mark of conformity with the Medical Device Directive
0476
This product is certified to conform to the Class IIa requirements of the 93/42/EEC Medical Devices Directive.
1.4.5 Warning symbol for the USB serial port
1.4.6 Warning symbol for the SpO2 port for oximetry
SpO2
1.4.7 (ESD) Electrostatic discharge sensitivity symbol
The (ESD) symbol required by the international standard EN 60601-1-2 is used in the vicinity of any connector which has not undergone electrostatic discharge testing.
1.5 Product description
MiniSpir is a spirometer and pulse oximeter, and is connected to a Personal Computer using a USB cable.
MINISPIR User manual Rev 1.1 pagina 8 di 22
The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart beat.
The main features of this multipurpose MiniSpir make it is easy to use and versatile.
Spirometry function
MiniSpir 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 MiniSpir (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 DISPOSABLE 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.
MiniSpir is connected to a PC trough a USB port. Data measured by MiniSpir 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 MiniSpir 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.
MiniSpir is able to make FVC, VC & IVC, MVV and breathing profile tests, 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.
Oximetry function (optional)
The oximetry sensor has two light emitting diodes (LEDs), one emits in the visible spectre and one infrared. Both lights then pass through the finger and are “read” by the receiver. As these lights pass through the finger, a proportion of the light is
MINISPIR User manual Rev 1.1 pagina 9 di 22
