Spirodoc User Manual Code - MIR Spirodoc User Manual

1. INTRODUCTION
1.1 Intended use
The spirodoc spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of
a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single patient
device and can be used in any setting- home, factory, pharmacy, hospital or physician office.
1.1.1 User category
The spirodoc spirometer + oxymeter measures a series of parameters relating to human respiratory function.
The product is therefore intended for use by a doctor or by a paramedic under the supervision of a doctor.
1.1.2 Qualification and experience required
The correct use of the instrument, the interpretation of the test results plus the maintenance of the instrument, in
particular the disinfection (to avoid the risk of cross-infection), all require qualified personnel.
1.1.3 Operating environment
The operation of the instrument is foreseen within a doctor's office or within a hospital ward.
The instrument is not intended for use in an operating theatre or in the presence of inflammable liquids or detergents, nor
in the presence of inflammable anaesthetic gases or oxygen or nitrogen gases.
The instrument is not designed to be used in direct air currents (eg wind), sources of heat or cold, direct sun light or other
sources or light or energy, dust, sand or any other chemical substances.
The user is responsible to check the suitability of the environmental conditions both for the storage and for the use of the
instrument.
WARNING
If spirodoc is exposed to unsuitable environmental conditions, this could cause the device to malfunction and to
give incorrect results
1.1.4 Who must/can make the installation
The spirodoc requires installation by qualified personnel. It is the responsibility of the user of the instrument to make the
required operations.
1.1.5 Patient effect on the use of the instrument
A spirometry test should only be carried out when the patient is at rest and is in good health, and thus in a suitable
condition for the test. A spirometry test requires the collaboration of the patient, the patient must make a complete
forced expiration in order to have a meaningful test result.
1.1.6 Limitations of use – Contraindications
An analysis of the results of a spirometry test is not in 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 any other tests suggested by a doctor.
Test comments, a test interpretation and suggested courses of 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 capacity of the patient to make a correct test and the
user must also assess the degree of collaboration for each test carried out.
A correct spirometry test always requires full collaboration from the patient. The results obtained always depend upon the
patient making a complete inspiration and then a complete expiration of air at the maximum possible velocity. If these
conditions are not respected then the results obtained will not be reliable and therefore the results are "not medically
acceptable".
The acceptability of a test is the responsibility of the user. Special attention should be given to testing elderly patients,
children plus handicapped people.
The instrument should never be used when it is possible or probable that the validity of the results may be compromised
due to any such external factors.
1.2 Important safety warnings
spirodoc has been examined by an independent laboratory which has certified the conformity of the device to the
European Safety Standards IEC 60601-1 and guarantees the EMC Requirements within the limits laid down in the
European Standard IEC 60601-1-2
The spirodoc is continually controlled during its production and therefore the product confirms to the established
security levels and quality standards laid down by the Council Directive 93/42/CEE for MEDICAL DEVICES.
After removing the device from its package, control that there is no visibile damage present, pay particular attention to
any flaws or cracks in the plastic casing that may lead to exposure of electrical components.
WARNING
The safety and the correct performance of the unit can only be assured if the user of the instrument respects all
of the current safety rules and regulations.
The manufacturer accepts no responsibility for problems or damage caused by the failure of the user to follow
these instructions correctly. The instrument must be used as described in the User's Manual with particular

spirodoc user manual code 980165

Rev 4.5 page 4 of 27