Spirobank II
Rev.1.6
Page 5 of 35
User manual
1.1.4
Patient effect on the use of the device
A spirometry test should only be carried out when the patient is at rest and in good health, in suitable testing conditions. A spirometry
test requires the full
collaboration
of the patient since she/he must perform a complete forced expiration, in order to obtain a reliable
test result.
1.1.5
Limitations of use
–
Contraindications
An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the patient’s clin
ical condition. A
detailed clinical history of the patient is also required together with the results of any other test(s) suggested by a doctor.
Test comments, a test interpretation and suggested therapeutic treatment must be given by a doctor.
Any symptoms that the patient has at the time of the test must be carefully considered before a spirometry test is made. The user is
responsible to assess both the mental and the physical condition of the patient in order to perform a proper test, furthermore, in the
evaluation of test results, the user must also assess the degree of collaboration of each test carried out.
A spirometry test requires the full collaboration of the patient. The results depend on the person’s ability to inspire as mu
ch air as possible
and to expire all of the air as fast and for as long as possible. If these fundamental conditions are not respected then the results obtained
during spirometry testing will not be considered accurate, and therefore the test results are “not acceptable”.
The acceptability of a test is the responsibility of the doctor. Special attention should be given when testing elderly patients, children and
handicapped people.
The device should not be used if any conceivable or actual anomalies or malfunctions appear which may compromise the accuracy of
the results.
WARNING
When used as a pulse oximeter the Spirobank II has limited alarms, therefore the device requires frequent display observation
of SpO2 and pulse rate.
1.2
Important safety warnings
Spirobank II
has been examined by an independent laboratory which has certified the compliance of the device to the European
Safety Standards EN 60601-1 and guarantees the EMC Requirements within the limits laid down in the European Standard EN 60601-
1-2.
Spirobank II
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 ins
tructions.
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.
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.
The device should not be used beyond the declared life span.. In normal conditions the lifespan of the device 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.
1.2.1
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.
