Comeg DUO Full HD Manual De Uso página 56

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Required information
2.5.2 Patient population restriction
The user is the only person who can decide whether or not to treat his/her patients.
2.5.3 Applied part(s)
The camera and light cable are deemed to be applied parts within the meaning of the IEC
60601-1 standard.
2.6 Basic safety and Essential Performance
2.6.1 Normal conditions of use
The normal usage conditions are as follows:
• Storage
• Installation
2.6.2 Essential performances
As stated in the applicable safety standard pertaining to electrical medical devices, the
manufacturer has determined that the medical devices do not manage any essential performance.
A lack of performance such as loss of image does not lead to unacceptable risk because the
intervention can continue either by changing the camera by another, or by looking directly
through the optics of the endoscope.
A degradation of performance such as an erroneous image does not entail an unacceptable risk
because the analysis of the image is left to the judgment of the practitioner, his experience and
his training. The device has only one role of aid to visualization, the intervention can continue
either by changing the camera by another, or by looking directly through the optics of the
endoscope.
A lack of performance as a loss of lighting does not lead to unacceptable risk because the
intervention can continue by changin the ligh soure or the logh guide by another one.
A degradation of performance such as loss of lighting does not lead to an unacceptable risk
because the intervention can continue by changin the ligh soure or the logh guide by another
one.
It is recommended to have a second camera or light source available in the operating theatre
so that action can be taken if the device fails to perform or if a deterioration in performance is
noticed.
As a highly skilled medical expert, the practitioner can immediately detect any problems at the
treatment area and react accordingly.
2.7 Lifetime
The lifetime of e device is 7 years (re-usable device)
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• Use
• Maintenance
• Disposal