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.
In combination with a suitable light guide the device meets the BF classification
requirements for protection from electric shock according to IEC 60601-1 and is
approved for use in combination with applied parts. This approval does not in-
clude use of the device in combination with applied parts intended for direct con-
ductive contact with the heart.
Light guides that meet the requirements for applied parts classified as type BF
feature the adjacent symbol.
Light guides that meet the requirements for applied parts classified as type CF of-
fer an even higher level of protection. They feature the adjacent symbol.
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
There are no medical contraindications associated with use of the light source it-
self separate from the endoscopic system.
Depending on the medical condition of the patient, contraindications may exist in
respect to the patient’s general condition or specific disease pattern.
The decision to perform an endoscopic procedure remains with the responsible
surgeon 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
.
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Instructions For Use | 13 - Mar - 2020 | Version: H
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