System Preparations - COOK Medical EchoTip Ultra Manual

WARNING
Not for use in the heart or vascular system .
PRECAUTIONS
When performing fine needle injection (FNI), ensure that injectable
material does not contact untargeted site .
When targeting multiple sites, replace device for each site .
Refer to package label for minimum channel size required for this device .
Needle must be retracted into sheath and thumbscrew on safety
ring must be locked to hold needle in place prior to introduction,
advancement or withdrawal of device . Failure to retract needle may
result in damage to endoscope .

SYSTEM PREPARATIONS

1. For FNI and/or Access, skip to step 4 .
2. For fine needle aspiration (FNA), 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)
3. 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 suction .
d. Set prepared syringe aside if aspiration biopsy is desired .
4. 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
Illustrations
1. Identify desired biopsy/injection site by endoscopic ultrasound .
2. Introduce ultrasound needle into accessory channel and advance
device in small increments until Luer lock fitting at base of sliding sheath
adjuster meets fitting on accessory channel . (See fig . 3)
2