Boston Scientific Expect Slimline M00555500 Instrucciones De Uso página 6

After each procedure has been performed, follow instructions below for
removal of needle.
needle removal:
1. Retract the needle fully into the sheath using the device handle by sliding
the handle away from the echoendoscope until it stops moving. Secure the
needle using the needle adjustment lock prior to withdrawing the device
from the echoendoscope.
caution: Ensure that the needle is fully retracted into the sheath. Failure to secure
the needle could result in damage to the echoendoscope or injury to user.
2. Lower the elevator on the echoendoscope.
caution: Failure to lower the elevator prior to withdrawal may cause damage
to the device.
3. Detach the device from the echoendoscope by turning the luer connection
counterclockwise. Slowly and carefully remove the device from the
echoendoscope.
After device has been removed from endoscope, follow instructions below for
disposal of needle.
needle Disposal:
1. After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.
caution: Do not use the same device to perform multiple indications. Use of
the device for multiple indications has not been established.
specific Instructions per Indication:
Sampling of submucosal and extramural gastrointestinal lesions (fine needle
aspiration)
1. Prepare device, supplied syringe, and stopcock as previously noted. Rotate
the stopcock to the closed position, perpendicular to the syringe. Pull the
syringe plunger to the desired volume and use the locking fins and stop pin on
the syringe to secure the plunger in place. (Figures 1(c) and 1(d)).
caution: Methods of providing suction other than the supplied syringe are not
recommended with this device.
2. Connect the supplied syringe to the aspiration port (Figure 2 (f)) on the
device handle.
3. Turn the stopcock to the open position (parallel to the device handle) to
apply suction.
4. Maneuver the needle within the target site to maximize aspiration sample
collection while observing needle penetration on the ultrasound image.
5. After an adequate number of passes have been made with the needle,
close the stopcock by rotating until it is perpendicular to the syringe. This
will stop suction.
6. Remove needle from echoendoscope (Refer to steps above).
7. After the device has been removed from the echoendoscope, release the
needle adjustment lock and advance the device handle to extend the needle
out of the sheath.
Black (K) ∆E ≤5.0
8. Remove the syringe and stopcock from the aspiration port.
9. Open the stopcock on the syringe by rotating it to the position that is parallel
to the syringe. Pull the syringe plunger back to pull air into the syringe.
10. Reconnect the syringe to the aspiration port.
11. Push the syringe plunger forward to expel the aspiration sample from the needle.
note: The locking fins and stop pin (Figures 1(c) and 1(d)) will have to be
disengaged in order to pass air from the syringe.
caution: Take precautions to ensure that the aspiration sample does not spray
when it is expelled from the needle. The aspiration sample should be treated
as infectious material and could create an infection risk.
12. Prepare the aspiration sample per institutional protocol.
note: Multiple passes may be required to obtain an adequate aspiration sample.
13. If additional passes to the same target site are required, prepare the device
by flushing the needle and wiping the stylet with sterile water or saline.
Reinsert the stylet into the needle, examine the needle for damage, and
repeat instructions.
caution: Failure to flush the needle and wipe the stylet prior to reinserting
the stylet into the needle could make the stylet difficult to pass or result in
damage to the device.
14. Dispose of needle (Refer to steps above).
Delivery of injectable materials (fluids)
1. Prepare device and load the supplied syringe with fluid.
2. Connect the supplied syringe to the aspiration port (Figure 2(f)) on the
device handle.
3. Use the supplied syringe to inject desired quantity of fluid into the targeted
injection site.
4. Remove needle from echoendoscope (Refer to steps above).
5. Determine if additional fluid needs to be injected. If so, prepare the device by
flushing the needle with sterile water or saline, repeat instructions for delivery
of injectable materials (fluids).
6. Dispose of needle (Refer to steps above).
Delivery of fiducials (luer loading)
1. While preparing device per initial instructions and prior to turning the
endoscope elevator control knob to lower the elevator, follow manufacturer's
instructions to prepare the fiducial transfer device to load the fiducial.
2. Per the manufacturer's instructions, deliver the fiducial.
caution: Ensure the stylet is not inadvertently advanced prior to or during
needle insertion into the lesion. Advancing the stylet prior to or during needle
insertion into the lesion may result in premature deployment of the fiducial.
caution: Severe flexion of the endoscope may result in inability to deliver
the fiducial.
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