Spirodoc
cod. 980156
Rev 1.3
EN 5/67
E
N
GLI
S
H
2.1.1
User category
SPIRODOC
spir oximeter calculates a series of parameters relating to human
respiratory function.
Typically the doctor “prescribes” a spirometry test and is responsible for analysing and
checking the results obtained.
2.1.2
Ability and experience required
The correct use of the device, the interpretation of the results and the maintenance of
the device all require qualified personnel. In the event that the device is to be operated
by a patient, sufficient training must first be given to the patient by the doctor or by a
trained paramedic under the supervision of a doctor.
WARNING
The manufacturer cannot be held responsible for any damage caused by the
user of the device failing to follow instructions and warnings in this manual.
If the user of the device is a person considered to be cognitively impaired the
operation of the device must be made under the supervision and
responsibility of whoever is legally responsible to supervise this person.
WARNING
When used as a pulse-oximeter, the SPIRODOC is intended for spot-
checking, overnight sleep screening and/or continuous monitoring when
used by a trained healthcare professional.
2.1.3
Operating Environment
SPIRODOC
has been designed for use in the
doctor‟s office, in a hospital or directly by
the patient to continuously monitor her/his physical conditions during routine daily
activities. All information necessary for the proper use of the device in an
electromagnetic environment (as required by the EN 60601-1-2 Standard) is available
in Annex 3 of this manual.
Used at home, at work, at school or during physical activity, day after day the device
records data and functional respiratory parameters for weeks or even months, helping
the patient to better assess her/his own health.
The procedures for using the device at home are described according to the type of
test to be made; the display will show all instructions (messages, suggestions etc.)
step-by-step, which allows the patient to correctly perform tests and obtain correct
results, to be analysed by the doctor.
The device is not intended for use in an operating theatre nor in the presence of
inflammable liquids or detergents, nor in the presence of inflammable anaesthetic
gases (oxygen or nitrogen).
The device is not designed to be used in direct air drafts (e.g. wind), sources of heat or
cold, direct sunlight or other sources of light or energy, dust, sand or any chemical
substances.
The user and/or doctor is responsible for ensuring that the device is stored and used in
appropriate environmental
conditions;
in this regard reference is made to the
specifications described in paragraph 2.7.3 below.
