Entellus Medical XprESS Mode D'emploi page 5

Bivirkninger
Mulige bivirkninger omfatter, men er ikke begrænset til, følgende:
•
Lækage af cerebrospinalvæske
•
Beskadigelse af orbitalvæggen eller andre øjenstrukturer
•
Vævsinfl ammation eller traume
Kompatibilitet
Enheden er kompatibel med XprESS-systemet til ØNH-dilatation (alle
sugespidsstørrelser)
Der henvises til vejledningen i brug af XprESS-systemet til ØNH-dilatation for
detaljerede oplysninger og anvisninger til brug af XprESS.
Brugsanvisning
BEMÆRK: Trin 1-3 er kun nødvendige, hvis LED Light Fiber er pakket
selvstændigt. Hvis LED Light Fiber er pakket sammen med XprESS-enheden,
gås til TRIN 4.
1. Tag LED Light Fiber ud af beskyttelsesemballagen.
2. Indfør fi beren i arbejdslumenen på XprESS-enheden (fi gur 2).
3. Tilkobl LED Light Fiber-indsatsen til låsefi ttingen på XprESS-enheden (fi gur 3).
Sørg for, at fi berens distale spids befi nder sig ud for XprESS-enhedens distale
ende (fi gur 4).
Figur 2 Figur 3
Specifi kationer
Enhed
Vægt
Fiberens nominelle arbejdslængde
Fiberens ydre diameter
Lyskilde (rød LED)
Aktiveringstid
Batteritype
Spændingskilde
Maksimal LED-udgangseffekt ved behandling
Funktionsmåde
Temperaturinterval for sikker funktion
Temperaturinterval til sikker opbevaring og transport
Relativt luftfugtighedsinterval for sikker drift, opbevaring og transport
Overholder sikkerhedsstandarderne for medicinsk udstyr:
Overholder EMC-standarden for medicinsk udstyr:
Figur 4
4. Form den indsatte XprESS-enhed til den bøjningskonfi guration, der ønskes
til den sinus, der skal behandles.
5. Aktiver LED Light Fiber ved at fjerne træktappen. Kontroller, at der sendes
lys gennem LED Light Fiber.
6. Under endoskopisk visualisering placeres XprESS-enheden på målstedet
for at belyse og gennemlyse de nasale strukturer og sinusstrukturerne.
- Projiceret lys kan forstærkes ved at føre spidsen af LED Light Fiber en
smule fremad distalt for XprESS-enheden.
7. Efter proceduren bortskaffes enheden i henhold til gældende nationale
og lokale bestemmelser og relevante miljømæssige sikkerhedsforskrifter.
Må ikke sendes til forbrænding, medmindre der er tale om et kontrolleret
forbrændingsanlæg.
Specifi kation
< 40 gram
27,6 cm
0,375 mm (0,015").
625 nm bølgelængde
Over 60 minutter
Lithium-mangandioxid, CR2, 3 Volt
Intern spændingskilde
1 W
Kontinuerlig
15-33 °C (59 - 91°F)
-10-50 °C (14-122 °F)
0-95 % relativ fugtighed
IEC 60601-1:2005; CAN/CSA-C22.2 nr. 60601-1-08
IEC 60601-1-2:2007, type BF anvendt del
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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 infl ation 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 infl ation 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 Infl ation Syringe (See Figure 5). If the seal and black mark
do not align, disconnect the Infl ation 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 defl ation of the
balloon. If a leak is detected and the source cannot be identifi ed and
corrected, do not use the XprESS device, Extension Line, and Infl ation
Syringe. Use new devices to complete the procedure.
f. If suction or irrigation is planned, connect the Extension Line to the
proximal barbed fi tting to add a fl exible connector for suction or irrigation.
Alignment between the Distal Seal and the
Distal Mark Corresponds to 12atm
Distal Seal Distal Mark
Orange Piston
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.
− 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 7: Sphenoid Bend
Figure 9: Maxillary 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 confi guration 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 fi nger at about the 2 cm mark on the suction
tip and use this fi nger to form the Maxillary Bend (Figure 11).
Figure 10: Figure 11:
Start Maxillary Bend Finish 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 orifi ce using one of the following
confi rmation methods:
a. Direct Visualization with or without Light Confi rmation: 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 confi rmation 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 LoProfi le may also
be used.
i. If using the GuideWire with XprESS Pro, attach the Tuohy Adapter to
the XprESS proximal barbed fi tting.
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 LoProfi le, load the
GuideWire 0.6 through the working lumen of XprESS until the luer
lock connector meets the proximal barbed fi tting of XprESS.
v. Secure the luer lock connector on the proximal barbed fi tting.
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 confi guration.
Note: Do not attach the XprESS device to other image guidance systems.
c. Fluoroscopy: If further confi rmation of the treatment area is desired,
fl uoroscopy may be used. Take two orthogonal views (AP and lateral).
The XprESS device suction tip is stainless steel and is visible under
fl uoroscopy. The balloon will be proximal to the tip of the device.
2. Under endoscopic visualization, track the XprESS device to the same
treatment area identifi ed 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 fi eld during
device positioning. Cover suction vent with fi nger 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 infl ating balloon, discontinue the use of suction (remove fi nger 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 Infl ation Syringe plunger rod to infl ate 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 Infl ation Syringe – see Figure 5). If these do not align, defl ate
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