System Preparation - COOK Medical EchoTip Ultra Manual

SYSTEM PREPARATION

1. Examine syringe. It has two plunger locks that must be depressed to advance plunger. Tip of
syringe has a Luer lock fitting with a stopcock on the side port. Air can be exchanged when
stopcock is in "open" position, aligned with syringe. (See fig. 1)
2. Prepare syringe as follows:
a. With stopcock in "open" position, depress plunger locks and fully advance plunger
into syringe.
b. Turn stopcock 90° to "closed" position.
c. Pull plunger back until it is locked into place at desired setting, creating a suction.
d. Set prepared syringe aside until aspiration biopsy is desired.
3. Advance device into ultrasound endoscope to determine preferred sheath length. To adjust
length, loosen thumbscrew lock on sliding sheath adjuster and slide until preferred length
is attained. Note: Reference mark for sheath length will appear in sliding sheath adjuster
window. (See fig. 2) Tighten thumbscrew on sliding sheath adjuster to maintain preferred
sheath length.
INSTRUCTIONS FOR USE
1. Identify desired biopsy site by endoscopic ultrasound.
2. With needle retracted into sheath and safety ring locked at 0 cm mark, introduce ultrasound
needle into accessory channel of endoscope and advance device in small increments
until Luer lock fitting at base of sliding sheath adjuster meets fitting on accessory channel.
(See fig. 3)
3. Attach device to accessory channel port by rotating device handle until fittings
are connected.
4. With ultrasound endoscope and device straight, adjust needle to desired length by
loosening thumbscrew on safety ring, and advancing it until desired reference mark for
needle advancement appears in the window of safety ring. (See fig. 4) Tighten thumbscrew
to lock safety ring in place. Note: Number in safety lock ring window indicates extension of
needle in centimeters. Caution: During needle adjustment or extension, ensure device has
been attached to accessory channel. Failure to attach device prior to needle adjustment or
extension may result in damage to endoscope.
5. While maintaining position of ultrasound endoscope, extend needle by advancing needle
handle to pre-positioned safety ring.
Advance needle into lesion. Caution: When advancing needle, excessive force may result in
6.
unintended needle extension
7. Remove stylet from needle by gently pulling back on plastic hub seated in metal fitting of
needle handle. Preserve stylet for use if additional cell collection is desired.
8. Attach Luer lock fitting of previously prepared syringe securely onto metal fitting of handle.
9. Turn stopcock to "open" position aligned with syringe, allowing negative pressure in syringe
to aspirate cells. Gently move handle in small increments back and forth within biopsy site.
Note: Do not remove needle from biopsy site during cell collection.
10. Upon completion of cell collection, retract needle into sheath by pulling back on handle
shaft. Lock thumbscrew on safety ring at 0 cm mark.
11. Disconnect Luer lock fitting from accessory channel and withdraw entire device from
ultrasound endoscope.
12. Unlock thumbscrew on safety ring and extend needle. Exchange locking syringe for an
empty syringe and attach new syringe to Luer lock fitting on handle.
13. Push in plunger to expel aspirate specimen, then prepare per institutional guidelines.
14. Aspirate remaining can be recovered for examination by flushing device.
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