Instructions For Use - Entellus Medical XprESS Mode D'emploi

Anbefalede separationsafstande mellem bærbart og mobilt RF-kommunikationsudstyr og LED Light Fiber
LED Light Fiber er tilsigtet anvendelse i elektromagnetisk miljø med kontrolleret RF-interferens. Kunden og brugeren af LED Light Fiber kan
hjælpe med at forebygge elektromagnetisk interferens ved at opretholde en minimumsafstand mellem bærbart og mobilt RF-kommunikationsudstyr
(sendere) og LED Light Fiber som anbefalet nedenfor, i forhold til den maksimale udgangseffekt på kommunikationsudstyret.
Senderens maks.
150 kHz til 80 MHz
udgangseffekt (Watt)
d =(1,2) (√P)
IR
0,01
(LED Light Fiber forsynes med strøm
0,1
fra internt batteri)
1
Test af immunitet over for
ledningsbårne forstyrrelser induceret
10
af RF-felter er ikke relevant, hvilket
medfører, at der ikke fi ndes nogen
100
data for separationsafstande i
intervallet fra 150 kHz til 80 MHz.
Tilstand ved levering
XprESS-systemet til ØNH-dilatation leveres sterilt og er kun beregnet til engangsbrug. Enheden må ikke resteriliseres og/eller genanvendes, da det kan medføre en
forringet ydelse og risiko for ukorrekt sterilisation og krydskontaminering. Åbnede eller beskadigede pakninger må ikke anvendes, da enhedens sterilitet og funktion
kan være påvirket.
Begrænset garanti
Der henvises til Entellus Medical, Inc. Standardbetingelser.
Symboler
Genbestillingsnr. Partinummer Modelnummer
STERILE
Sterilisering med
Må ikke genanvendes
Antal
ethylenoxidgas
Type BF
for del i berøring
med patient
Indeholder ikke naturlig gummilatex.
XprESS, Pathassist og Light Fiber er varemærker, der tilhører Entellus Medical.
Patent http://www.entellusmedical.com/patents
Separationsafstand i forhold til senderfrekvens (m)
80 MHz til 800 MHz 800 MHz til 2,5 GHz
d =(1,2) (√P) d =(2,3)(√P)
0,12
0,38
1,2
3,8
12
Producent Se vejledningen i brug
Autoriseret forhandler i EU
EO
Må kun anvendes
Anvendes inden
efter lægeordination
78

INSTRUCTIONS FOR USE

ALL INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD
BE CAREFULLY READ AND UNDERSTOOD BEFORE USE.
FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.
Caution – Federal (USA) law restricts this device
to sale by or on the order of a physician.
Indication for Use
To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years
0,23
and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12
years and older using a transnasal approach. The bony sinus outfl ow tracts
0,73
are remodeled by balloon displacement of adjacent bone and paranasal
2,3
sinus structures.
7,3
To dilate the cartilaginous portion of the Eustachian tube for treating
persistent Eustachian tube dysfunction in patients 18 years and older using
a transnasal approach.
23
Description
The XprESS ENT Dilation System is intended to remodel or recreate the sinus
outfl ow tract and dilate the Eustachian tube by transnasal balloon dilation. The
XprESS device combines features of a curved suction tip and an ostium seeker
with the tissue expansion effect of balloon dilation. The familiar features of this
device enable a physician to track the device into the sinuses and Eustachian
tubes using endoscopic visualization. Since the distal end of the device is
re-shapeable, one balloon can be modifi ed to work on multiple sinuses and
Eustachian tubes within the same patient.
0086 Figure 1 – XprESS ENT Dilation Device
CE-mærke
The XprESS device curved suction tip has an atraumatic ball tip. A suction
tube may be connected to the proximal barbed fi tting to provide active suction
by covering the suction vent. An Extension Line connected to a syringe may
be connected to the proximal barbed fi tting to provide irrigation. The device
was designed to prevent fl uid from exiting the suction vent during irrigation.
The XprESS ENT Dilation System is provided sterile and for single use only.
The XprESS ENT Dilation System includes the XprESS device, Infl ation Syringe,
Bending Tool, and an Extension Line. The XprESS LoProfi le and Ultra ENT
Dilation Systems also include the PathAssist LED Light Fiber. The XprESS
Pro ENT Dilation System also includes a Tuohy Adapter.
XprESS is available in the following suction tip sizes and balloon sizes. All
suction tips and balloon lengths are appropriate for treating all sinuses and
Eustachian tubes; selection is based on physician preference.
XprESS Pro
Standard Suction Tip LoProfi le Suction Tip
(2mm ball tip, 1mm ID, (1.75mm ball tip, 0.7mm ID,
1.5mm OD)
Balloon Diameter ×
Length (mm)
NA
NA
6 × 8
6 × 18
7 × 18
The XprESS ENT Dilation System has been tested to withstand multiple
infl ations and device tip manipulations in a surgical case.
Contraindications
•
None known
Warnings
•
Never advance or withdraw the XprESS device against any resistance. Do
not use excessive force or torque to advance the XprESS device or balloon/
slide assembly when positioned in any paranasal or nasopharynx space.
Such actions could lead to tissue trauma, bleeding, or device damage.
•
Do not use breached or damaged packages, since the sterility and functionality
of the device may be compromised.
•
The XprESS ENT Dilation System is provided sterile and intended for single
use only. Do not resterilize and/or reuse, as it may result in compromised
device performance and risk improper sterilization and cross-contamination.
•
Do not use the XprESS device in patients with known allergies to
barium sulfate.
•
Do not use XprESS to dilate Eustachian tubes in patients with a history of
patulous Eustachian tubes.
•
Due to the variability of anatomy, review appropriate radiographic imaging
(eg, a CT scan) prior to treatment. Do not use the XprESS device to treat a
hypoplastic/atelectatic maxillary sinus, atelectatic ethmoid infundibulum, or
patients with evidence of internal carotid artery dehiscence.
•
Due to the variability of sinus development in pediatric patients, review CT
scan to assess each sinus's development and appropriateness for balloon
dilation. Pneumatizaton may occur as early as 1-2 years of age and continues
to develop throughout childhood. Do not use XprESS in a sinus that is not
adequately developed.
•
Do not insert the XprESS device beyond the tubal isthmus of the Eustachian
tube, as this may increase the risk of bony fracture and injury to the internal
carotid artery.
•
Do not advance the LED Light Fiber beyond the distal tip of XprESS when
XprESS is placed in the Eustachian tube, as this may lead to tissue trauma.
•
Do not exceed the maximum recommended balloon infl ation pressure of
12 atm. Over-infl ation of the balloon can result in serious adverse events.
•
Do not use ionic or non-ionic fl uoroscopic contrast solution to infl ate the
balloon in patients with known allergies to contrast media.
•
If suction through the XprESS device lumen is used during the procedure,
temporarily discontinue suction (remove fi nger from suction vent, disconnect
suction hose from device, or clamp suction hose) at the time of balloon
infl ation. Suction can resume subsequent to balloon defl ation. Using the
XprESS device in suction mode while balloon is infl ated may result in
barometric trauma to tissue, which may lead to increased bleeding or damage
to the tympanic membrane.
•
Do not irrigate within the Eustachian tube, as this may damage the
tympanic membrane.
•
As in any upper airway procedure or sinus surgery, do not have patient use
CPAP until the physician has confi rmed that the tissue is adequately healed.
CPAP use prior to soft tissue healing may result in facial and/or neck swelling
due to subcutaneous emphysema.
•
Do not clean the XprESS device with anti-microbial agents as the compatibility
of the XprESS device with these agents has not been tested.
•
The XprESS device has been tested only with the Fiagon Navigation System.
Do not attach the XprESS device to other image guidance systems, as
use with other systems may result in inaccurate device positioning. Refer
to System Operation 1.b for instructions on how to connect XprESS to the
Fiagon system.
•
The XprESS device has been tested only with the Entellus Infl ation Syringe.
XprESS LoProfi le XprESS Ultra Do not use other infl ation devices with the XprESS device, as doing so may
result in serious patient injury.
Ultra Suction Tip
Precautions
(1.5mm ball tip, 0.5mm ID,
1.2mm OD) 1.0mm OD)
○ Store the XprESS device components in a cool and dry place. Never use
Balloon Diameter × Balloon Diameter ×
a device that is beyond its expiration date.
Length (mm) Length (mm)
○ Handle the XprESS device with care. Prior to use, and during the procedure,
5 × 8 5 × 8
inspect the packaging and components for bends, kinks, or other damage.
5 × 20 5 × 20
Discontinue the use of the XprESS device if it may have been damaged.
6 × 8 6 × 8
○ Select a balloon diameter that will result in expansion of the tissue post
6 × 20 6 × 20
dilation. Do not select a balloon diameter that is larger than the bony margins
7 × 20 NA
of the outfl ow tract as this may damage the balloon.
○ Pay special attention when advancing or withdrawing the balloon and slide
assembly. If resistance is encountered, use endoscopy or direct visualization
to help guide device out of the paranasal or nasopharynx space and then
attempt to alleviate the resistance. If the cause of resistance cannot be
determined, do not use the XprESS device.
○ Use direct endoscope visualization with or without PathAssist LED Light
Fiber or Light Fiber to ensure accurate placement of the balloon prior to
dilation. If balloon location cannot be verifi ed, image guidance or fl uoroscopy
can be used. If balloon location still cannot be verifi ed, the balloon should
not be infl ated.
○ Consider using self-limiting radiation exposure equipment when employing
fl uoroscopy to confi rm device placement. Ensure the equipment is calibrated
and maintained according to the equipment manufacturer's user manual.
3