Principle Of Operation; User Population - Comeg DUO Full HD Manuel D'utilisation

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Required information
is sent from the DUO Full HD control unit along the light cable and then to the endoscope,
providing local illumination of the examination site.
The camera head included in the DUO Full HD unit is designed to relay the image captured at the
examination site to a monitor via the control channel. It is designed for use by health practitioners
qualified in diagnostics and surgical endoscopy procedures. The practitioner can also control
the image settings using three buttons on the camera head: adjust the LED brightness, or zoom
in/out, correct the white balance, move from flexible to rigid mode and vice versa, and capture
photos, and use the "Freeze" function. The camera head is designed for connection to the DUO
Full HD control unit and to a rigid or flexible endoscope via a lens (endoscope and lens not
included). The camera head is equipped with a sterile protective cover (not included) for the
duration of the diagnostic/surgical procedure.
Any use outside of these areas constitutes improper use of the product and the
user will therefore be considered responsible for such use. The manufacturer does not accept
any liability in this case.

2.3 Principle of operation

The lens, light cable (both optional) and camera head are cleaned, disinfected and/or sterilized
in accordance with the manufacturer's user manual. The control unit is used outside the sterile
field, unlike the proximal end of the camera head and light cable.
A compatible lens is fitted to the DUO Full HD camera head and the light cable is equipped with
compatible adaptors at the two ends. The camera head and light cable are connected to the
DUO Full HD control unit.
The other end of the light cable and camera head are connected to the endoscope. It is
recommended to use a sterile, single-use protective cover over the camera head and its cable
for the duration of the procedure.
The diagnostic or surgical procedure may now be performed. The cavity is illuminated and video
camera images are displayed on the monitor screen. The images may be stored on a USB key
connected to the front of the DUO Full HD control unit.
2.4 User population recommendations

2.4.1 User population

This medical device is intended for use by a graduated, fit and qualified surgeon during
endoscopic exploration.
This device may also be used by an assistant or nurse under the supervision of the surgeon.
This device is suitable for use in a professional healthcare facility environment.
Users must know and comply with the rules of endoscopy practice in compliance with knowledge
acquired in the field and the key medical hygiene principles including cleaning, disinfection and
sterilisation of MDs.
The user must wear gloves.
The user is not the patient.
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