Entellus Medical XprES Instrucciones De Uso página 4

b. Begin with the Inflation Syringe plunger all the way in (Figure 2).
c. Then submerge tip in sterile saline solution.
d. Fill Inflation Syringe by slowly drawing plunger back to second click position
(all the way out) (Figure 4).
e. Attach an Extension Line to the filled Inflation Syringe.
f. Point the syringe tip towards the ceiling. Tap the Inflation Syringe until a large
bubble is visible beneath the orange piston.
g. While still pointing the syringe tip towards the ceiling, push the plunger all
the way in (Figure 2), to purge all air and fluid from the syringe.
h. Submerge the free end of the Extension Line in sterile saline solution. Slowly
draw plunger back to the first click position (Figure 3) to fill the syringe.
2. Prepare XprESS ENT Dilation System.
a. Remove the XprESS device from its sterile package.
b. Remove and discard the balloon protector.
c. Connect the free end of the prepped Extension Line to the XprESS balloon
inflation luer.
Note: Inspect the syringe barrel to ensure there is minimal air in the system. If excessive air remains in the
system, repeat prepping process.
d. Perform a test inflation of the system by depressing the plunger rod until the distal black seal on the orange
piston is aligned with the distal black mark of the Inflation Syringe (See Figure 5). If the seal and black
mark do not align, disconnect the Inflation Syringe and Extension Line and repeat the prepping process.
e. Pull the plunger rod back to the 2nd click to apply a vacuum to the balloon. Ensure there is no air introduced
into the system during deflation of the balloon. If a leak is detected and the source cannot be identified
and corrected, do not use the XprESS device, Extension Line, and Inflation Syringe. Use new devices to
complete the procedure.
f. If suction or irrigation is planned, connect the Extension Line to the proximal barbed fitting to add a flexible
connector for suction or irrigation.
Alignment between the Distal Seal and the
Distal Mark Corresponds to 12atm
Distal Seal
Figure 5: Alignment between Distal Seal and Distal Mark
Re-shaping the XprESS Device Suction Tip to Treat Multiple Spaces
− When treating multiple spaces, it is recommended to complete balloon dilation of the frontal or sphenoid sinuses
or Eustachian tubes prior to treatment of the maxillary sinuses.
− Frontal Sinuses: When treating the frontal recesses, a large radius curve similar to a frontal sinus seeker
(Figure 6) is recommended. This is the shape/curve provided in the package.
− Sphenoid Sinuses: When treating the sphenoid sinus ostia, a slight bend (Figure 7) is recommended.
Distal Mark
Orange Piston
− Eustachian Tubes: When treating the Eustachian tubes, a bend of approximately 45° at the 2 cm mark
(Figure 8) is recommended.
− Maxillary Sinuses: When treating the maxillary ostia/ethmoid infundibula, a bend of approximately 120 - 135°
(Figure 9) is recommended to gain access to the natural maxillary ostium. Use the included Bending Tool to
achieve this geometry.
Figure 6: Frontal Bend
Figure 8: Eustachian Tube Bend
− Small adjustments to the above bends may be considered to accommodate different patient anatomy.
Using Bending Tool
− The Bending Tool should be used to achieve the proper maxillary bend. The tool also provides a frontal and
sphenoid bend configuration if needed.
− Maxillary Bending with Bending Tool: Before shaping the maxillary bend, the device should be close to straight
as shown for a Sphenoid Bend. With the Bending Tool in one hand, position the ball tip into the ball holder in
the bending tool (Figure 10). Place a finger at about the 2 cm mark on the suction tip and use this finger to
form the Maxillary Bend (Figure 11).
Figure 10: Start Maxillary Bend
Patient Preparation
1. Patient preparation should be consistent with standard practice.
2. Anesthesia should be administered appropriately to allow patient tolerance.
System Operation
1. Locate the sinus structure or Eustachian tube orifice using one of the following confirmation methods:
a. Direct Visualization with or without Light Confirmation: Locate the treatment area using XprESS with or
without LED Light Fiber, Light Fiber, Light Seeker, a standard sinus ostium seeker, and/or guidewire with the
aid of an endoscope. Observe the location of the treatment area relative to the anatomical landmarks through
the endoscope. Remove the Light Seeker, sinus ostium seeker, or guidewire after locating treatment area.
Note: If using the PathAssist LED Light Fiber or Light Fiber, refer to the Instructions for Use (IFU) for
complete instructions.
b. CT Image Guidance: If further confirmation of the treatment area location is desired, CT image guidance
using the Fiagon Navigation System and GuideWire or GuideWire 0.6 with XprESS Pro may be used. The
Fiagon Navigation System and GuideWire 0.6 with XprESS LoProfile may also be used.
i. If using the GuideWire with XprESS Pro, attach the Tuohy Adapter to the XprESS proximal barbed fitting.
ii. Load the Fiagon GuideWire through the Tuohy Adapter and working lumen of XprESS until the tip of
GuideWire aligns with the tip of XprESS.
iii. Secure the GuideWire in place by tightening the Tuohy Adapter.
iv. If using GuideWire 0.6 with XprESS Pro or LoProfile, load the GuideWire 0.6 through the working lumen
of XprESS until the luer lock connector meets the proximal barbed fitting of XprESS.
v. Secure the luer lock connector on the proximal barbed fitting.
vi. Refer to Fiagon Navigation System Instructions for Use.
Note: Neither of the Fiagon GuideWires should be used with any XprESS device in the maxillary bend
configuration.
Note: Do not attach the XprESS device to other image guidance systems.
c. Fluoroscopy: If further confirmation of the treatment area is desired, fluoroscopy may be used. Take two
orthogonal views (AP and lateral). The XprESS device suction tip is stainless steel and is visible under
fluoroscopy. The balloon will be proximal to the tip of the device.
2. Under endoscopic visualization, track the XprESS device to the same treatment area identified above.
a. Position XprESS suction tip within the sinus ostia or within the cartilaginous portion of the Eustachian tube.
Notes: Reference marks are located 1 and 2 cm from the tip of the device.
The XprESS suction tip may be reshaped to aid in device positioning.
Use device as a suction tool to maintain a clear visual field during device positioning. Cover suction
vent with finger to allow suction.
3. Advance the balloon by fully advancing the balloon slide mechanism forward to position the balloon within
the sinus opening or Eustachian tube.
4. Prior to inflating balloon, discontinue the use of suction (remove finger from suction vent, disconnect suction
hose from device, or clamp suction hose) to decrease the risk of barotrauma.
5. Balloon dilation of the treatment site:
a. Slowly depress the Inflation Syringe plunger rod to inflate the balloon. The pressure should be increased
slowly (3-5 seconds) until the orange piston bottoms out (distal black seal of the piston reaches the distal
black mark on the Inflation Syringe – see Figure 5). If these do not align, deflate the balloon and remove
the XprESS device and perform a test inflation (as described in steps 2.d and 2.e of the System Preparation
section). Alignment of the distal mark and distal seal will ensure that 12 atm of pressure is reached.
Note: Do not use air or any gaseous medium to inflate the balloon.
b. Inflate the balloon until the desired result is achieved or until it reaches 12 atm.
Sinus Dilation: Inflate the balloon for up to 20 seconds (less than or equal to 20 seconds); observe that
the balloon is inflated endoscopically.
Eustachian Tube Dilation: Inflate the balloon for approximately 2 minutes by holding in the plunger rod;
observe that the balloon is inflated endoscopically.
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Figure 7: Sphenoid Bend
Figure 9: Maxillary Bend
Figure 11: Finish Maxillary Bend