Danger Of Cross-Contamination - MIR Spirodoc User Manual

attention to § Intended Use and only original spares and accessories as specified by the manufacturer may be
used. The use of a non-original turbine sensor of other parts could cause measurement errors and/or
compromise the correct functioning of the instrument, and is therefore not permitted. In the event of any kind of
accident arising from the use of the device, the patient must inform his doctor and the doctor must
communicate the full details (adverse event reporting), as instructed in article.9 of the European Directive CE
n.93/42 law, D.Lgs. n. 46/1997.
1.2.1

Danger of cross-contamination

The instrument uses a turbine sensor. A mouthpiece is required to connect a patient to the spirometer.
WARNING
In order to avoid exposing the patient to the critical danger of cross contamination, the turbine sensor must
always be disinfected before each spirometry test, and a new single use mouthpiece must be used for each new
patient.
1.2.2 The turbine
An incorrect or insufficient disinfection of the turbine could be a cause of infection for the patient.
A regular cleaning is strongly recommended. See the relevant paragraph within this manual for details of the correct
operation for disinfection.
Do not expose the turbine sensor to a direct jet of water or air nor allow it to come into contact with liquid at high
temperature.
Do not allow dust or foreign bodies to enter the turbine sensor, to avoid incorrect functioning and possible damage.
The presence of any impurities such as hairs, sputum, threads etc within the body of the turbine sensor may "brake" the
propellor and thus seriously compromise the accuracy of the measurements.
1.2.3 The mouthpiece
Any single-use mouthpieces included with the instrument are supplied only as a guide to the correct type and dimensions
of the mouthpiece required for this instrument, they are clean but not sterile. To purchase appropriate mouthpieces
(generally either paper or plastic, in any case single-use/disposable) we suggest that you contact your local distributor
who supplied the spirometer.
WARNING
The use of a mouthpiece made from an inappropriate material could modify the bio-compatibility and could
cause a malfunction of the instrument and thus incorrect test results.
The user is responsible to obtain the correct type of mouthpieces for the instrument. Those required are a standard type
with an outside diameter of 30mm, they are commonly used and in general easily procured.
1.2.4 The Pulse oxymetry sensor
Prolonged use and/or the patient's condition may require changing the sensor site periodically. Change sensor site and
check skin integrity, circulatory status, and correct alignment at least every 4 hours. Prolonged use may cause blisters,
skin deterioration and discomfort.
WARNING
Incorrectly applied sensors may cause inaccurate readings.
Using a damaged sensor may cause inaccurate readings, possibly resulting in patient injury or death. Inspect
each sensor before use.
If a sensor appears damaged, do not use it. Use another sensor or contact your authorized repair centre for help.
Using a damaged patient cable may cause inaccurate readings, possibly resulting in patient injury or death. Inspect the
patient cable. If the patient cable appears damaged, do not use it. Contact your authorized repair centre for help.
Use only MIR SpO2 sensors supplied with, or specifically intended for use with the spirodoc. Use of sensors not
intended for use with the spirodoc may cause inaccurate readings.
Oximetry measurements may be inaccurate in the presence of high ambient light. Shield the sensor area (with a surgical
towel, for example) if necessary.
WARNING
Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, patent blue
V (PBV), and fluorescein may adversely affect the accuracy of the oximetry reading.
Any condition that restricts blood flow, such as the use of a blood pressure cuff or a device for systemic
vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings.
Remove fingernail polish or false fingernails before applying oximetry sensors.
Fingernail polish or false fingernails may cause inaccurate SpO2 readings.
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