Directions For Use - Boston Scientific Expect Slimline M00555500 Instrucciones De Uso

2. Examine the syringe (Figure 1). The syringe barrel has one stop pin (Figure
1 (d)) and the syringe plunger has four locking fins (Figure 1(c)). The syringe
plunger can be maneuvered within the syringe barrel to lock and unlock the
syringe. To lock the syringe, pull back on the plunger until it aligns with the
desired suction volume (Figure 1(a)). Turn the plunger clockwise so that the
locking pin engages with the locking fins on the plunger (Figure 1(b)). Turn the
plunger counterclockwise to release.
note: The stopcock is required in order to maintain suction during the procedure.
caution: If the stopcock is not set properly, adequate suction may not be achieved.
product Use
figure 2.
2(a): Luer Attachment 2(d): Needle Adjustment Lock
2(b): Sheath Adjust Gauge 2(e): Needle Depth Gauge
2(c): Sheath Adjust Lock 2(f): Aspiration Port and Stylet Cap

Directions for Use

For additional instructions per indication, refer to specific instructions below.
preparation Instructions:
1. Remove the needle from the package and examine it for damage.
2. Confirm that the needle is fully retracted and that the needle adjustment lock
(Figure 2(d)) is secure in the zero position (Figure 2(e)).
3. Determine the appropriate sheath length relative to the length of the
echoendoscope. Use the sheath adjustment lock (Figure 2(c)) to set the
desired length of the sheath and lock it in place. Turn the sheath adjustment
lock clockwise to lock the sheath in place. The distal end of the sheath should
be visible on the endoscopic image.
note: The reference numbers and markings on the sheath adjust gauge
(Figure 2(b)) are intended as reference only.
4. Turn the endoscope elevator control knob to lower the elevator.
caution: Failure to lower the elevator prior to insertion may cause damage to
the device.
5. Introduce the catheter into the echoendoscope working channel. Slowly
advance the device through the working channel on the echoendoscope.
caution: If resistance is encountered, stop pushing and reposition the
catheter or the echoendoscope. Pushing too hard could cause damage to
the echoendoscope.
6. Continue to advance the device until it exits the echoendoscope and the
sheath is visible in the endoscopic image. Tighten the luer attachment (Figure
2(a)) by turning clockwise to attach the device to the working channel port of
the echoendoscope.
note: If it is necessary to adjust the sheath length, loosen the sheath adjustment
lock (Figure 2(c)) and reposition it to the appropriate reference point.
caution: Do not tighten the luer connection too tightly to the echoendoscope
as it may cause damage to the echoendoscope.
caution: Prior to advancing the needle, ensure that the device is securely
fastened to the echoendoscope and both the needle adjustment and
sheath adjustment locks are secure. Failure to do so could result in
damage to the echoendoscope.
caution: Insufflation performance may be diminished when device is attached
to the echoendoscope.
7. Verify the distance from the distal end of the sheath to the target site using the
ultrasound image.
8. Adjust the needle penetration depth to the desired position using the needle
adjustment lock (Figure 2(d)). To control the depth of needle penetration
to the target site, loosen the needle adjustment lock by turning the knob
counterclockwise. Align the needle adjustment lock with the appropriate
reference number on the device handle. Lock in place by turning the needle
adjustment lock clockwise.
note: The reference numbers on the needle depth gauge (Figure 2(e))
are intended as reference only. The reference numbers represent needle
extension (in centimeters) when the device is in a straight position.
9. Advance the needle by sliding the handle toward the echoendoscope in a
slow and controlled motion to penetrate the target site while observing the
ultrasound image.
note: If it is necessary to adjust the amount of needle penetration, loosen the
needle adjustment lock, reposition, and lock it to the appropriate reference point.
10. Remove the stylet (Figure 2(f)) from the aspiration port of the device by gently
loosening and pulling it from the device handle.
note: For delivery of fiducial via needle tip, stylet should be positioned per
fiducial manufacturer's instructions. Continue to instructions below for
delivery of fiducials (loading via needle tip).
note: The stylet can be coiled and clipped together using the clip mechanism
on the stylet cap (Figure 2(f)). The stylet should be retained for additional
needle passes during the same procedure.
caution: Failure to properly handle the stylet could result in damage to the device.
caution: The stylet tip is sharp. Take precautions to ensure that the stylet is
handled properly. After it has been removed from the needle, the stylet should
be treated as infectious material and could create an infection risk.
5
Black (K) ∆E ≤5.0