MIR SPIRODOC Manual De Usuario página 53

1.1.6 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 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
people with disabilities. The device should not be used if any conceivable or actual anomalies or malfunctions appear which may
compromise the accuracy of the results.
Spirometry has relative contraindications:
Due to increased myocardial demand or changes in blood pressure
- Acute myocardial infarction within 1 week
- Systemic hypotension or severe hypertension
- Significant atrial/ventricular arrhythmia
- Uncompensated heart failure
- Uncontrolled pulmonary hypertension
- Acute pulmonary heart
- Clinically unstable pulmonary embolism
- History of syncope related to forced expiration/cough
Due to increased intracranial/intraocular pressure
- Cerebral aneurysm
- Brain surgery within 4 weeks
- Recent concussion with persistent symptoms
- Eye surgery within 1 week
Due to increased sinus and middle ear pressure
- Sinus or middle ear surgery or infection within 1 week
Due to increased intrathoracic and intraabdominal pressure
- Presence of pneumothorax
- Thoracic surgery within 4 weeks
- Abdominal surgery within 4 weeks
- Pregnancy beyond term
Due to infection control problems
- Active or suspected transmissible respiratory or systemic infection, including tuberculosis
- Physical conditions predisposing to transmission of infection, such as haemoptysis, significant secretions or oral lesions or oral
bleeding.
WARNING
When Spirodoc is used as a pulse oximeter with limited alarms setting, the SpO
to be checked frequently.
1.2 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.
Spirodoc is continuously checked during manufacturing and therefore the product complies with the established security levels and
quality standards laid down by by European Regulation (EU) 2017/745.
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 as described in this user manual 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.
SPIRODOC cod. 980156 Rev 4.2.1
and Pulse Rate shown on the display needs
2
EN 7/48
spirodoc
User manual