User Manual

Spirodoc cod. 980156 Rev 1.3 EN 6/67
ENGLISH
WARNING
Exposure to unsuitable environmental conditions may cause the device to
malfunction, and to provide incorrect results.
2.1.4 Who can or must make the installation
The device requires installation by qualified personnel. The doctor will configure the
device before handing it over to the patient for homecare use.
2.1.5 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.
2.1.6 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 clinical 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 much air as possible and to expire all of the air as
fast and for as long as possible. If these fundamental conditions are not achieved the
results obtained during spirometry testing may not be considered accurate, and
“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 SPIRODOC has limited alarms, therefore
the device requires that the user frequently observe the SpO2 and pulse rate
on the display.
2.2 Important safety warnings
SPIRODOC 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.