COOK Medical EchoTip Ultra Nadel zur Neurolyse des Plexuscoeliacus Gebrauchsanweisung Seite 6

PRECAUTIONS
Refer to package label for minimum channel size required for this device.
The needle must be retracted into the sheath and the thumbscrew on the safety ring
must be locked at the 0 cm mark to hold the needle in place prior to introduction,
advancement or withdrawal of the device. Failure to retract the needle may result in
damage to the endoscope.
Ensure the stylet is fully inserted when advancing the needle into the target site.
A thorough understanding of the technical principles, clinical applications and risks
associated with endoscopic ultrasound and celiac plexus neurolysis is necessary before using
this device. The use of prophylactic antibiotics is recommended for endoscopic ultrasound-
guided celiac plexus neurolysis. The use of general anesthesia may be needed in some cases.
Do not use this device for any purpose other than stated intended use.
Use of this device is restricted to a trained healthcare professional (Rx only).
INSTRUCTIONS FOR USE Illustrations
1. Identify the desired injection site by endoscopic ultrasound.
2. With the needle retracted into the sheath and the thumbscrew on the safety ring locked
at the 0 cm mark to hold the needle in place, introduce the ultrasound needle into the
accessory channel of the scope. Caution: If resistance is encountered on needle introduction,
reduce angulation of the scope until smooth passage is allowed.
3. Advance the device, in small increments, until the Luer lock fitting at the base of the
sliding sheath adjuster meets the Luer fitting on the accessory channel port.
4. Attach the device to the accessory channel port by rotating the device handle clockwise
until the fittings are connected.
5. Adjust the sheath to the desired position, ensuring that it is visible on the endoscopic
image, emerging from the working channel of the scope. To adjust length, loosen the
thumbscrew lock on the sliding sheath adjuster and slide until the preferred length is
attained. Note: The reference mark for the sheath length will appear in the sliding sheath
adjuster window (Fig. 1). Tighten the thumbscrew on the sliding sheath adjuster to maintain
the preferred sheath length.
6. While maintaining position of the scope, set the needle extension to the desired length by
loosening the thumbscrew on the safety ring, and advancing it until the desired reference
mark for needle advancement appears in the window of the safety ring (Fig. 2). Tighten the
thumbscrew to lock the safety ring in place. Note: The number in the safety lock ring window
indicates the extension of the needle in centimeters. Caution: During needle adjustment
or extension, ensure the device has been attached to the accessory channel of the scope.
Failure to attach the device prior to needle adjustment or extension may result in damage to
the scope.
7. Extend the needle, by advancing the needle handle of the device to the pre-positioned
safety ring, to the desired injection site. Caution: If excessive resistance is encountered on
needle advancement, retract the needle into the sheath with the thumbscrew locked at the
0 cm mark, reposition the scope and attempt needle advancement from another angle.
Failure to do so may result in needle breakage, device damage or malfunction.
8. Remove the stylet from the ultrasound needle by gently pulling back on the plastic
hub seated in the Luer fitting of the needle handle. Preserve the stylet for use if additional
neurolysing injections are required later.
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