MiniSpir
User manual
MINISPIR
User manual
Rev 1.9
page 5 of 18
1.2
Important safety warnings
MiniSpir
has been examined by an independent laboratory which has certified the conformity of the device to the Safety Standards
IEC 60601-1
and guarantees the EMC Requirements within the limits laid down in the Standard
IEC 60601-1-2
.
MiniSpir
is throughly tested during its production and therefore the product complies with the safety requirements and quality
standards laid down by the Council Directive 93/42/EEC for
MEDICAL DEVICES.
After removing the device from its packaging, check that there is no visible damage. In case of damage do not use the device and
return it to the manufacturer for replacement.
WARNING
The safety and the correct performance of the device can only be assured if the user of the device respects all of the
relevant safety rules and regulations.
The manufacturer cannot be held responsible for damage caused by the failure of the user to follow these instructions
correctly.
The device must be used according with the indications given by the manufacturer in the User Manual with particular
attention to § Intended Use utilizing only original spare parts and accessories. Use of non original parts such as the
turbine flow sensor and oximetry sensor or other accessories may cause errors in measurement and/or compromise the
correct functioning of the device, and is therefore not permitted.
In particular, the use of cables other than those specified by the manufacturer could cause increased emissions or lower
electromagnetic immunity fom the device and result in improper operation.
In the event of any incident or accident of any kind resulting from the use of the device, the user is required to inform
the manufacturer without delay, according with Directive 93/42/EEC on Medical Devices.
1.2.1
Danger of cross-contamination
Two different types of turbine sensors can be used with the device: one is single-patient disposable and one is reusable. A
mouthpiece is required in order to connect a subject to the spirometer.
In order to avoid exposing the subject to the hazard of cross-contamination, the reusable flow sensor must always be cleaned
before each spirometry test, and a new disposable mouthpiece must always be used for each subject. The use of an anti bacterial
filter is at the discretion of the doctor.
If a disposable turbine is used, then a new one must be used for each patient.
1.2.2
Turbine
Disposable turbine
If you are going to perform the spirometry test with a disposable turbine, it
is important to use a new turbine for every new patient. The characteristics,
accuracy and the hygiene of the disposable turbine can only be guaranteed
if it has been stored beforehand in its original sealed packaging.
The disposable turbine is made of plastic and its disposal after use should
adhere to the local authority guidelines / norms.
Reusable turbine
The correct funtioning of the re-usable turbine can only be guaranteed if it
has been cleaned in the correct manner and is free from foreign bodies
which could alter its movement. If the turbine has not been cleaned
sufficiently this could cause cross contamination from one patient to
another.
The cleaning of the turbine should be done following the guidelines in the
user manual.
The following informations are valid for both models of turbine.
Do not expose the turbine to a direct jet of water or air, and avoid contact with high temperature liquids.
Do not allow dust or foreign bodies to enter the turbine sensor, in order to avoid incorrect functioning and possible damage. The
presence of any impurities (such as hair, sputum, threads etc.) within the body of the turbine sensor may seriously compromise
the accuracy of the measurements.
Notes about calibration of reusable turbine
WARNING
The turbine flow sensor does not require calibration but needs only a regular cleaning. If a calibration must be made then
the following guidelines should be carefully noted.
Calibration can be made using a siring a calibration syringe ad making a FVC test.
In line with the publication "Standardised Lung Function Testing" of the European Respiratory Society (Vol 6,
Supplement 16, March 1993), the air expired from the mouth is at a temperature of circa 33/34 °C.
The expired flow and volume, to be converted to BTPS conditions (37 °C) must be increased by 2.6% - this is derived
from the BTPS factor of 1.026 at a temperature of 33°C, which represents a correction of 2.6%. In practice the BTPS factor
for the expired flow and volumes is therefore constant and equal to 1.026.