I.A.C.E.R. Srl
6
MNPG262-02
Classifications
In accordance with point 1.1 of Annex IX of DIRECTIVE 93/42/EEC
(and subsequent amendments), the LaMagneto is a type of device
designed for continuous use for less than 24 hours. According to point
1.4 of the same annex, the device relies on an electrical energy source,
therefore it is considered as an active medical device. With reference to
point 1.5 of the mentioned annex, the LaMagneto is an active
therapeutic device, as it is intended for the treatment of various types of
conditions. In accordance with Rule 9, paragraph 3 of Annex IX of
Directive 93/42/EEC, all active therapeutic devices intended for the
administration or exchange of energy are in Class IIa unless their
characteristics are such as to enable them to release energy to the
human body or exchange energy with the human body in a potentially
dangerous form, taking into account the nature, density and part where
the energy is applied, in which case they fall into class IIb. Considering
the fact that pulsed magnetic fields do not fall into the category of
ionising radiation, and that do not involve direct application of electric
current on the patient, it can be said that the energy exchanged by the
device with the human body is not at all dangerous.
Therefore, the devices of the LaMagneto line are active medical
devices belonging to class IIa. With regard to the second sentence of
Annex IX, "If several rules apply to the same device, based on the
performance specified for the device by the manufacturer, the strictest
rules resulting in the higher classification shall apply to the device of the
LaMagneto line. Therefore the classification is IIa.
The LaMagneto device assumes the following classifications:
•
Class II with type BF applied part (Classif. IEC EN 60601-1);
•
Device with IP21 degree of protection against the penetration of
solid objects, powders and liquids.
•
Device and accessories supplied non-sterile and not subject to
sterilisation;
•
Device not suitable for use in the presence of a flammable
anaesthetic mixture with air, with nitrous oxide, with any flammable
agent of any kind and in environments with a high concentration of
oxygen;
•
Device intended for continuous operation;
•
Device not suitable for external use.
