Professional LED Light System for All of Surgery Application
9
4. Introduction
4.1 Intended use
Ÿ
Major Surgical Luminaire (L200) is intended to be used to provide visible illumination
of the surgical area or the patient during surgical operations, diagnosis and
treatment.
Ÿ
Classification under the provision of 93/42/EEC(MDD) : Class I
-
Major Surgical Luminaire (L200) is classified as a Class I device.
Ÿ
Classification under the provision of
FDA (U.S. Food and Drug Administration)
: Class II
-
Major Surgical Luminaire (L200) is classified as a Class II(exempt) device.
Ÿ
Form of protection against electric shock : Class I
-
Major Surgical Luminaire (L200) is classified as Class I
Ÿ
Degree of protection against flammability
-
Major Surgical Luminaire (L200) is classified as a device not suitable to be used in a
potentially flammable environment.
-
Do not use near flammable materials.
Ÿ
Method(s) of sterilization or disinfection recommended by the manufacturer
-
The SIDE HANDLE should be cleaned with cloths, and the MAIN HANDLE should be
sterilized with sterilizer regularly to prevent disinfection.
Ÿ
Mode of operation
-
Classification of Major Surgical Luminaire: continuous operation.
