1 General Information about the Device
1.3 Usage
1.3 Usage
1.3.1 Intended Use
This light source is intended for use in endoscopy systems for human medicine.
In combination with a light guide, endoscope, and camera, its purpose is to illumi-
nate the inside of the human body.
1.3.2 Indications
There are no medical indications associated with the use of the light source if sep-
arated from the endoscopic system.
The indications for an endoscopic application depend on the medical condition of
the patient and the individual risk/benefit analysis by the surgeon.
1.3.3 Contraindications
The use of the endoscopic light source and its accessories is contraindicated in all
cases where endoscopic procedures are contraindicated for any reason.
As is appropriate with any surgical procedure, consideration must be given to pa-
tient size and workspace volume when using the endoscopic light source.
Depending on the patient’s medical condition, contraindications may exist that rely
on the general condition of the patient or the specific disease pattern.
The decision to perform an endoscopic procedure rests with the responsible sur-
geon and should be made on the basis of an individual risk-benefit analysis.
1.4 Conformity
1.4.1 Standards and Directives
The device meets the requirements of the following applicable standards:
IEC 60601-1 Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment - Part 1-2:
Electromagnetic compatibility
1.4.2 Medical Device Classification
The product is a Class I medical device within the meaning of applicable EU
guidelines.
Instructions For Use | 13 - Mar - 2020 | Version: B Page 48 of 78
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