Spirodoc
cod. 980156
Rev 1.3
EN 7/67
E
N
GLI
S
H
SPIRODOC
is continuously checked during manufacturing and therefore the product
complies with the established security levels and quality standards laid down by the
Council Directive 93/42/EEC for MEDICAL DEVICES.
After removing the device from its packaging, check to see that there is no visible
damage. In case of damage do not use the device and return it to the manufacturer for
repair.
WARNING
The safety and the correct performance of the device can only be assured if
the user respects all of the relevant safety rules and regulations.
The manufacturer will not be held responsible for damage due to user
’s
neglect to correctly to follow these instructions.
The device must be used only and exclusively as a spirometer following the
indications given by the manufacturer with particular attention to the
paragraph on INTENDED USE, and 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.
The device should not be used beyond the declared life span. The life span is
strictly related to the life of the internal lithium battery pack. In normal
conditions the lifespan of the battery pack is estimated to be around 10
years. The device constantly monitors the state of charge of this battery and
a message informs the user when the battery is discharged.
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, this
procedure is laid down in Article.9 of the European Regulations No. 46/1997,
which implemented the EC Directive No. 93/42.
2.2.1
Danger of cross-contamination
Two different types of turbine sensors can be used with the device, one is reusable
and the other is single-patient disposable. A disposable mouthpiece is required in
order to connect a patient to the spirometer. In order to avoid exposing the patient to
the critical danger 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 patient. The use of an anti-bacterial filter is at the discretion of the
doctor. If a single-patient disposable turbine is used, then a new one must be used for
each patient.
2.2.2
Turbine
Disposable turbine
WARNING
If you are going to perform a spirometry test with a
disposable turbine it is important to use a new turbine
for each new patient. The features, accuracy and
hygiene of the disposable turbine can only be
guaranteed if it has been conserved beforehand in its
original sealed packaging.
