Werbung
Verfügbare Sprachen
Verfügbare Sprachen
1.3
Usage
1.3.1
Intended Use
1.3.2
Indications
1.3.3
Contraindications
1.4
Conformity
1.4.1
Standards and Directives
1.4.2
Medical Device Classification
Instructions For Use | 7 - Feb - 2023 | Version: B
The application of a camera control unit in combination with the camera head and
endocoupler serves the visualization of the intracorporal surgical area during en-
doscopic diagnostic and surgical procedures. The camera control unit in combina-
tion with a camera head is only used for visualization and not for diagnosis. Refer
also to the intended use of the relevant additional components.
Minimally invasive surgical application.
Surgery, general endoscopic procedure.
The use of the camera components and its accessories is contraindicated if endo-
scopic procedures are contraindicated for any reason. As is appropriate with any
surgical procedure, consideration must be given to patient size and workspace
volume when using the camera components. Depending on the patient's disease,
there may exist contraindications 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 surgeon and should be made on the basis of an individ-
ual risk-benefit analysis.
The device consisting of controller and camera head 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
IEC 60601-2-18 Medical electrical equipment - Part 2-18:
Particular requirements for basic safety and essential performance of en-
doscopic equipment
The product is a Class I medical device within the meaning of applicable EU
guidelines.
1 General Information about the Device
1.3 Usage
Page 37 of 62
Werbung
