En - Instruction For Use; Intended Use; Product Description; Handling And Operation - G-flex 6 Manual Del Usario

EN - I
NSTRUCTION FOR USE

Intended Use

Cysto-Gastro-Sets are intended to be used to puncture pancreatic cysts or pseudo-
cysts endoscopically (via the transgastric or transduodenal wall) and to dilate the
opening to the cyst (6, 8.5 or 10Fr models) as an alternative to surgical or
percutaneous treatments. It is also indicated to dilate the access in the procedure of
Endoscopic ultrasonography-guided biliary drainage (EUS-BD).

Product Description

The device is made of an outer flexible teflon tube equipped with a metal tip at the
distal end and an HF connector in the proximal end (all models) images on page 3:
1. HF dilator
2. Guiding catheter
Handle
3. Luer-lock
4. Guide wire entry port
5. Dilator HF Connector
Advices before first application
Please read carefully and follow all safety operating instructions and warnings
before first application of the device.
A previous knowledge regarding handling and operation is required and essential.
Unpack the instrument carefully and examine the devices for any possibility of
damage. In case of any damage or missing items contact your distributor
immediately.
If the package present any damaged, the sterility of the device is not
guarantee.

Handling and Operation

Both parts of the device are supplied with HF connectors that need to be fixed to an
appropriate active cords.
It is recommended to use an echo-endoscope.
Cysto-Gastro-Sets require an endoscope´s working channel of at least 3.7
mm Ø for 10Fr Set, 3.2 mm Ø for the 8.5 Fr Set or 2.8 mm for the 6 Fr.
Use cut frequency only since the use or excess of coagulation frequency can
damage the product. Recommended frequency is between 80 and 120watts.
Procedure
After the size and position of the cyst or pseudo-cyst are determined by
endosonography, the device is inserted into the endoscope´s operating channel
over a guide wire (.025" or .035").
4