COOK Medical EchoTip ProCore Instrucciones De Uso página 10

INSTRUCTIONS FOR USE
1. Identify the desired 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 endoscope. (See Fig. 6)
Caution: If resistance is encountered on needle introduction, reduce angulation
of 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 of the accessory channel
port.
4. Attach the device to the endoscopes 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 endoscopically
visible, confirming that the sheath has emerged from the working channel of
the scope.
6. While maintaining position of the endoscope, 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 the needle advancement
appears in the window of the safety ring. (See Fig. 7) 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 endoscope. Failure to attach the device prior to needle
adjustment or extension may result in damage to the endoscope.
7. Extend the needle, by advancing the needle handle of the device to the
pre-positioned safety ring, into the lesion. Caution: If excessive resistance is
encountered on needle advancement, retract the needle ino 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 device
damage or malfunction.
8. Standard vacuum syringe techniques may be applied for biopsy (see steps
9 – 11) or, if desired, other techniques that may or may not incorporate the use
of the stylet may be used.
9. Remove the stylet of the ultrasound needle by gently pulling back on the
plastic hub seated in the metal fitting of the needle handle. Preserve the stylet
for use if additional biopsy is desired later.
10. Attach the Luer lock fitting of the previously prepared syringe securely into
the fitting on the needle handle.
11. Turn the stopcock to the "open" position aligned with the syringe, allowing
the negative pressure in the syringe to facilitate biopsy. Move the needle handle
back and forth within the biopsy site. Note: Do not remove the needle from the
biopsy site during biopsy.
12. Upon completion of biopsy, if using a syringe, turn the stopcock to the
"closed" position, retract the needle completely into the sheath by pulling back
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