Introduction; Intended Use; User Category; Ability And Experience Required - MIR Spirodoc Bedienungsanleitung

1.

INTRODUCTION

1.1

Intended use

The Spirodoc spirometer and pulse oximeter is intended to be used by a
under the instruction of a physician or of a licensed healthcare professional.
The device is intended to test lung function and can make:
•
spirometry testing in adult and pediatric patients, excluding infants and neonates
•
oximetry testing in people of all ages.
It can be used in hospital setting, physician's office, factory, pharmacy and
1.1.1

User category

Spirodoc spirometer and 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.
1.1.2

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.
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 the person legally responsible to supervise the cognitively impaired person.
WARNING
When used as a pulse-oximeter, Spirodoc is intended to provide measurements for diagnostic purposes. The trained
healthcare professional can get to a diagnosis by means of spot-checking, overnight sleep screening, or prolonged
monitoring.
Monitoring shall be performed for the time necessary and when the patient health conditions are such as to not show, imply
or presume an immediate danger to the patient.
In fact, Spirodoc is not specifically intended to monitor vital physiological parameters and the nature of variations of those
parameters is such that it could result in immediate danger to the patient (for example, like intensive care monitors,
emergency monitors).
1.1.3

Operating Environment

Spirodoc has been designed for use
Used at home, day after day the device records data and functional respiratory parameters for weeks or even months, helping the doctor
to assess the health patient.
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.
WARNING
Exposure to unsuitable environmental conditions may cause the device to malfunction, and to provide incorrect results.
1.1.4

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.
1.1.5

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
collaboration
test requires the full
test result.
SPIRODOC
in hospital setting, physician's office, factory, pharmacy and
of the patient since she/he must perform a complete forced expiration, in order to obtain a reliable
cod. 980156
physician, by a licensed healthcare professional or by a patient
home.
home.
Rev 4.2.1
spirodoc
User manual
EN 6/48