Spirolab
Rev.1.8
Page 8 of 60
1.2
Important safety warnings
Spirolab
devices have been examined by an independent laboratory that has certified their
conformity with EN 60601-1 safety standards and guaranteed that their electromagnetic
compatibility is within the limits laid out in EN
60601-1-2.
Spirolab
devices are subject to continuous checks during production and therefore comply
with the safety and quality standards laid down in Council Directive 93/42/EEC for
Medical Devices
.
Once the device has been removed from its packaging, examine it carefully to make sure
there are no signs of damage. In the event of any damage, do not use the device but return
it immediately to the manufacturer for possible replacement.
WARNING
Patient safety and device performance are only guaranteed if warnings and current
safety standards are complied with.
The manufacturer declines all responsibility for harm or damage caused by failure
to follow the instructions of use.
The product must be used as described in the User Manual, especially as regards §
Intended Use, and only original accessories as specified by the manufacturer are to
be used. The use or non-original turbine sensors, oximetry sensors or other
accessories might cause erroneous readings or compromise the correct functioning
of the device. For this reason, the use of such items is not permitted.
In particular, the use of cables other than those specified by the manufacturer could
cause increased emissions or lower electromagnetic immunity from the device and
result in improper operation.
Do not use the product if it has passed its shelf life. In normal working conditions,
this is equal to approximately 10 years.
The battery charge level is constantly monitored by the device itself. The device will
display a message warning the user if the battery is flat.
In the event of any incident arising from use of the device, we strongly advise the
user to inform his or her doctor, who will then complete the procedure laid down by
Article 9 of Legislative Decree No. 46/1997 implementing EC Directive No. 93/42.
1.2.1
Risk of cross contamination
So as to avoid any risk of cross contamination, it is imperative to use a single-use
mouthpiece for each individual patient.
The device may be used with two types of turbine sensors: a reusable one and a disposable
one.
Reusable turbine sensors must be cleaned before being used on a new patient. The use of
an anti-bacterial viral filter is left to the doctor's discretion.
The disposable turbine sensor must be replaced for each patient.
