Required Information; Intended Purpose - Comeg DUO Full HD Manuel D'utilisation

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Required information

Note: following notice is only applicable for the United States of America.
United States Federal Law restricts the use of this medical device within its territory to health
professionals who are qualified, fit and certified, or to those under their control.
2.1 Contents
The DUO Full HD device is a digital endoscopic cameras and light source. The device comprises
the following medical devices:
• One control channel,
• One Full HD camera head,
• A C-mount lens with a focal length of 18mm or greater (optional),
• One light cable (optional)
And the following accessories:
• One USB key with the user manual,
• One EU or US power cord,
• One SDI video cable,
• Two light cable-device adaptors (Olympus and Storz fittings)
• Universal light cable adaptors, source end (Storz fitting) and endoscope end (Storz fitting)
(optional)
This device has been delivered to you in cardboard packaging to be retained for use if transporting
the device.
Note: Any other consumable or accessory not sold by Sopro will have its own manual. Please
refer to it before using the product.
Keep the packaging in case you need to transport the equipment at a later date.
For the United States and Canada, user the "hospital grade" power cord supplied. This must be
connected to a "hospital grade" mains socket.

2.2 Intended purpose

This device and accessories associated are intended to provide local illumination of the patient's
body and to capture images taken by health practitioners qualified in diagnostic procedures or
surgical endoscopy procedures (gynecology, laparoscopy, arthroscopy, ENT, urology or spinal
endoscopy).
The DUO Full HD control unit is a medical device combining a Full HD camera and LED light
source over a single control channel.
On the camera side, the DUO Full HD enables the user to relay images to a monitor and capture
photos via the camera head combined with the lens and endoscope.
On the LED light source side, the DUO Full HD has a maximum of 23,000 lux light source. Light
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