1.2.3 Mouthpiece
Any disposable mouthpieces included with the device are supplied only as a guide to the correct type and dimensions of the
mouthpiece required for this device, they are clean but not sterile. To purchase appropriate mouthpieces, generally either paper or
plastic but in any case mono-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 be the cause
of an incorrect functioning of the device and thus of incorrect test results, and create inconvenience to the patient.
The user is responsible for obtaining the correct type of mouthpieces for the device. Those required are a standard type with an
outside diameter of 30 mm, they are commonly used and in general easily procured.
To avoid contamination of the environment, caused by the disposal of used mouthpieces, the user must follow all of the
relevant local regulations in force.
1.2.4 Device
WARNING
The maintenance operations detailed in this manual must be carried out to the letter. If these instructions are not
followed this can cause measurement errors and/or an incorrect test interpretation.
Any modifications, adjustments, repairs or reconfiguration must be made by the manufacturer or by personnel authorised
by the manufacturer. In case of problems, never attempt to make a repair oneself. The set-up of configurable parameters
should only be made by qualified personnel. However, an incorrect set up of the parameters does not put the patient at
risk.
High-frequency emissions from “electronic” devices may interfere with the correct operation of the instrument. For this
reason, certain minimum clearances (a few metres) should be observed when high-frequency appliances such as a TV,
radio, portable phone, etc. and other electronic units are operated at the same time in the same room.
The instrument may give inaccurate readings if operated in the presence of strong electromagnetic sources or in the
presence of other medical devices such as echographies.
When connected to other devices to preserve the safety oft he system as required in the IEC 60601-1 standard, it is
necessary to use exclusively device compliants with the safety rules. So the PC or the printer which the Smart One® is
connected must be compliant with IEC 60601-1.
If the PC connected to Smart One
®
is used in the area containing the patient, it is necessary that the PC complies with
the EN 60601-1 Standard (ref. EN 60601-1-1 Standard).
For the disposal of the Smart One®, the accessories, plastic consumable materials (mouthpieces) plus the battery, use
only the appropriate containers or return all such parts to the seller of the instrument or to a recycling centre. All
applicable local regulations must be followed.
If any of these rules are not followed then MIR will decline all responsibility for any direct or indirect damages, however
caused.
1.3 Unforeseen errors
If any problems should arise with the device, a message indicating the nature of the problem will appear on the screen of the PC,
together with a warning “beep”.
Errors in measurement or in interpretation can also be caused by:
use by non-qualified or non-trained personnel, lacking ability or experience
user error
use of the instrument outside the guidelines described in this User's Manual
use of the instrument even when some operational anomalies are encountered
non-authorised servicing of the instrument.
1.4 Labels and symbols
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