I-Tech UT1032 User Manual page 4

The product has been assigned to class IIa, according to Annex IX, rule 9 of
the Directive 93/42/EEC (and further modifications/integrations) and bears
the mark
Compliance of the concerned product with the Directive 93/42/EEC has been
assessed and certified by the Notified Body:
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
Classification
From now on, for the sake of simplicity, in this user manual, reference will be
made to the device MIO-SONIC meaning the device model UT1032, name
MIO-SONIC.
The MIO-SONIC has the following classification:
•
class IIa (Directive 93/42/EEC, Annex IX, rule 9, 10 and further
amendments);
•
class II with BF type applied part (classification EN 60601-1);
•
unprotected device, IPX0 protection degree based on penetration of
liquids and dust. Degree of protection IPX7 is for the treatment head.
DEVICE NOT SUITABLE FOR USE WITH IMMERSION;
•
equipment and accessories not subject to sterilization;
•
equipment unsuitable for use in presence of a flammable anesthetic
mixture containing air, oxygen and nitrous oxide;
•
equipment suitable for continuous operation;
•
equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use:
Environmental intended use:
0197 – TÜV Rheinland LGA Products GmbH
Tilly straße 2 – 90431 Nürnberg, Germany
Certificate n°: HD 60147882 0001
Therapeutic
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