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
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)
3. Attach device to endoscope 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 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 is 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.
6. Advance needle into lesion, intra- or extra-hepatic bile ducts, pancreatic duct,
cystic duct or gallbladder.
7. Remove stylet from needle by rotating stylet cap anti clockwise and gently
7