Spirolab
Rev.1.8
Page 6 of 60
1.
INTRODUCTION
1.1
Intended use
The Spirolab
spirometer and pulse oximeter is intended to be used by a physician, by a
licensed healthcare professional or by a patient under the instruction of a physician or of
a licensed healthcare professional.
The device is intended to test lung function and can make:
•
for spirometry tests in adult and pediatric patients, excluding infants and neonates
•
for oximetry tests in people of all age.
It may be used in in hospital setting, physician's office, factory, pharmacy.
1.1.1
User type
The
spirolab
spirometer and oximeter (optional) provides information about a series of
parameters relating to human respiratory function.
Use of the device is usually "prescribed" by a doctor, who is responsible for analysing and
checking the results and the data gathered during the test period.
1.1.2
Ability and experience required
The technique for using and maintaining the device along with the ability to interpret the
results provided calls for a qualified health worker.
WARNING
MIR will not be held responsible for any harm or damage of any kind caused by
mistakes made by users failing to heed the warnings in this manual.
If a spirolab user is a person who is incapable of looking after him or herself, the
device must be used under the supervision and responsibility of the person who is
legally in charge of that person.
When the spirolab device is used as an oximeter, it is intended for spot checks.
1.1.3
Where the device is used
The
spirolab
device was designed for use in hospital setting, physician's office, factory,
pharmacy.
The product is not suitable for use in operating theatres or in the presence of flammable
liquids or detergents, or where there are anaesthetic gas mixtures that become flammable
in the presence of air, oxygen or nitrous oxide.
The product is not suitable for use where it may be exposed to air currents (e.g. the wind),
sources of heat or cold, direct sunlight or other sources of light or energy, dust, grit or
chemical substances.
