Gima SATURNO WALL, Руководство по эксплуатации

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MO003-GB 18/05/06
Operative Manual
Rev.0 Page 7 of 34
1.3 Classification and destination of use of the device
Classification according to a particular regulation (CEI EN 60601-2-41 regulation section 2)
Secondary scialytic lamp for surgery (treatment lamp):
single lamp in the patient zone that assures an
adequate illumination at the centre to illuminate the patient’s body locally. It is designed to be used in the
operating theatre, for treatments and diagnoses that can be interrupted without danger to the patient in the
case of lighting failure.
Classification of the medical devices in terms of the 93/42 EEC directive (attachment IX)
Short-term, active and not invasive medical device destined for local illumination of the patient. In terms
of the above, the device is considered as falling into class I, according to rule 1.
Classification according to a general regulation (CEI EN 60601-1 regulaton article 5)
•
On the basis of the type of protection against electrical danger: class I apparatus
•
On the basis of the type of protection against direct or indirect contact: type B apparatus
•
On the basis of protection against penetration of water: ordinary apparatus
•
On the basis of the level of safety of use in the presence of an inflammable anaesthetic mixture with
air or oxygen or hydrogen protoxide: apparatus considered not suitable for use with the above
described elements.
•
On the basis of the conditions of use: apparatus for continuous functioning.