Device Description; Indications For Use; Contraindications; Safety Precautions When Using The Flexible Video-Uretero-Renoscope - Storz FLEX-XC Series Instruction Manual

Flexible video-uretero-renoscope
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General Information for the Safe Use of
the Flexible Video-Uretero-Renoscope

Device Description

The KARL STORZ Flexible Video-Uretero-Renoscope has a working length of 675 mm with an outer diameter of 2.9 mm.
The shaft consists of a working channel, 1.2 mm in diameter, that can be used for insertion of various flexible instruments.
The distal tip houses a CMOS imaging sensor for capturing images and videos. The handle encloses a LED light source,
deflection lever and control buttons.
The LED light source provides the illumination for visualization of the anatomy under examination. The deflection lever
deflects the distal tip 270 degrees in an UP/DOWN direction. The control buttons can be programmed to perform functions
such as white balance, Image Capture, zoom and to provide access to the setup menu.
The KARL STORZ Flexible Video-Uretero-Renoscope when used with compatible Camera Control Unit (CCU) and accesso-
ries from the KARL STORZ Flexible Ureteroscope System. There are three different system configurations possible. Please
refer to the system configuration matrix shown under Compatible Camera Control Units section of this instruction manual.
Please refer to the proper CCU manual for instructions on how to use the Camera Control Unit.
Videoscopes are applied parts which should only be used with supply units (camera control units) specified for this purpose
by KARL STORZ.

Indications for Use

The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can
be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeu-
tic procedures.

Contraindications

There are no known contraindications relating directly to the product. The Flexible Video-Uretero-Renoscope must not be
used if, in the opinion of a qualified physician, such an application would endanger the patient, or if the endoscopic method
as such is contraindicated.

Safety Precautions When Using the Flexible Video-Uretero-Renoscope

The Flexible Video-Uretero-Renoscope must be used according to the recognized medical rules and procedures of endos-
copy.
Note: The patient leakage current limit of the CF applied parts may be exceeded if CF applied parts (application on heart)
are used in combination with other BF applied parts.
In this case, the patient leakage current can be reduced by using only CF applied parts.
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