DENTIS LUVIS L200 - 4 Introduction; Intended Use

Professional LED Light System for All of Surgery Application
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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.