Entellus Medical XprESS Mode D'emploi page 4

○ Use techniques for reducing fl uoroscopic exposure when using fl uoroscopy.
Examples are applying pulsed beam settings, increasing target-to-panel
distance, using posterior-anterior projection, and using appropriate lead
shield protection. Total fl uoroscopy time should be limited to 30 minutes.
○ When fl uoroscopy is used, especially in children, minimize radiation dose
to the lens of the eye and other proliferating tissues due to the potential for
cataract formation or injury to the surrounding tissue.
○ Do not advance or withdraw a guidewire through the XprESS Pro or LoProfi le
suction/irrigation lumen against resistance. This could lead to device damage.
○ Be aware that guidewires (including Fiagon GuideWires) do not track through
the XprESS Pro or LoProfi le when they are bent in the recommended
maxillary confi guration or through the XprESS Ultra in any confi guration.
Other methods can be used to obtain confi rmation of the treatment area,
such as use of the PathAssist Light Fiber, direct visualization of the XprESS
device with an aid of an endoscope, or fl uoroscopic imaging of the XprESS tip.
○ Use standard larger suction tubes for removal of thick secretions or other
materials. XprESS Pro has a 1 mm ID comparable to that of a 5F suction
tube. XprESS LoProfi le has a 0.7 mm ID comparable to that of a 4F suction
tube. XprESS Ultra has a 0.5 mm ID comparable to that of a 2.5F suction
tube. All are capable of removing blood and thin mucous.
○ Fully defl ate the balloon and retract the balloon slide assembly before
withdrawing the XprESS device from the paranasal or nasopharynx space.
○ Use only liquid contrast or saline solution for infl ation. Do not infl ate with air.
○ Consider using a new balloon if cross-contamination between sinuses or
Eustachian tubes is a concern.
Adverse Effects
Possible adverse effects include, but are not limited to, the following:
• Complication • Cavernous • Revision surgery
from anesthesia sinus syndrome • Tinnitus
• Damage to the • Damage to the • Damage to the
lamina papyracea lacrimal sac Eustachian tube
affecting tearing
• Damage of the • Patulous
orbital wall or other • Pneumocephalus
Eustachian tube
structures of the eye • Bruising and swelling • Permanent
• Cerebrospinal • Tissue infl ammation hearing loss
fl uid leak
• Fever and infection • Carotid artery damage
• Loss of vision
• Continued or • Tympanic
or diplopia
worsening symptoms membrane damage
(double vision)
• Pain
• Bleeding
Supplies
The following supplies are not provided with the XprESS ENT Dilation System
and should be available and prepped prior to use of the device.
− Appropriate endoscopes and compatible camera system
− ≥50 mL of sterile saline solution, sterile fl uoroscopic contrast solution, or
sterile water
− Needles and syringes as required for injections
− 20-30 mL syringe and Extension Line (if irrigation is to be performed)
− Suction system
− Other supplies or medication as established by laboratory protocol
− If the use of a sterile guidewire is desired (compatible with the XprESS Pro),
the recommended guidewire should be sterile and ≤0.035 inches in diameter
with a minimum length of 50 cm. Example of a guidewire that meets these
requirements is the Entellus Medical Sinus Guidewire.
− If desired, Entellus Medical PathAssist™ LED Light Fiber, Light Fiber™,
or Light Seeker
Optional Equipment
− Fiagon Navigation System and GuideWires (GuideWire and GuideWire
0.6 are compatible with XprESS Pro; GuideWire 0.6 is compatible with
XprESS LoProfi le)
− Fluoroscopy may be used in conjunction with the endoscope if desired.
− Refer to appropriate Instructions for Use and safety procedures when
preparing and using equipment.
Instructions for Use
System Preparation
1. Prepare the Infl ation Syringe and
Extension Line
a. Remove the Infl ation Syringe
and Extension Line from its
sterile package. Figure 2 - Plunger all the way in
Note the 3 referenced Infl ation
Syringe plunger positions:
Figure 3 - First Click position
Figure 4 - Second Click position
(all the way out)
b. Begin with the Infl ation Syringe plunger all the
way in (Figure 2).
c. Then submerge tip in sterile saline solution.
d. Fill Infl ation Syringe by slowly drawing plunger
back to second click position (all the way out)
(Figure 4).
e. Attach an Extension Line to the fi lled Infl ation
Syringe.
f. Point the syringe tip towards the ceiling. Tap
the Infl ation 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 fl uid from
the syringe.
h. Submerge the free end of the Extension Line
in sterile saline solution. Slowly draw plunger
back to the fi rst click position (Figure 3) to fi ll
the syringe.
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Elektromagnetisk kompatibilitet (EMC)
Elektrisk medicinsk udstyr kræver særlige forholdsregler, hvad angår EMC, og skal installeres og sættes i drift i henhold til EMC-forskrifterne i dette afsnit. Bærbart og
mobilt RF-kommunikationsudstyr kan påvirke elektrisk medicinsk udstyr.
Vejledning og producentens erklæring – Emissioner
LED Light Fiber er beregnet til brug i elektromagnetiske miljøer som angivet nedenfor.
Kunden eller brugeren af LED Light Fiber skal sikre, at den anvendes i et sådant miljø.
Emissionstest Overensstemmelse Elektromagnetisk miljø - Retningslinjer
RF-emissioner CISPR 11 Gruppe 1 LED Light Fiber anvender udelukkende RF-energi til sin interne funktion. Derfor er emissionen meget
svag og ikke tilbøjelig til at forårsage interferens med nærtstående elektrisk udstyr.
RF-emissioner CISPR 11 Klasse B LED Light Fiber kan anvendes i alle miljøer, også i hjemmet, og i bygninger, der er direkte tilsluttet
det offentlige lavspændingsforsyningsnet til beboelsesbygninger.
Harmoniske strømkilder IR
IEC 61000-3-2
Flimren IEC 61000-3-3 IR
Vejledning og producentens erklæring – Immunitet
LED Light Fiber er beregnet til brug i elektromagnetiske miljøer som angivet nedenfor.
Kunden eller brugeren af LED Light Fiber skal sikre, at den anvendes i et sådant miljø.
Immunitetstest EN/IEC 60601-testniveau Overensstemmelsesniveau Elektromagnetisk miljø - Retningslinjer
ESD EN/ ±6 kV kontakt,
±6 kV kontakt, ±8 kV luft
IEC 61000-4-2 ±8 kV luft
±2 kV netspænding,
EFT EN/IEC 61000-4-4
±1 kV ind-/udgange
Spændingsbølge EN/ ±1 kV differentiale, IR
IEC 61000-4-5 ±2 kV fælles
(LED Light Fiber
forsynes med strøm fra
>95 % dyk over 0,5 cyklus
internt batteri)
60 % dyk over 5 cyklusser
Spændingsdyk/-udfald
EN/IEC 61000-4-11 30 % dyk over 25 cyklusser
>95 % dyk over 5 sekunder
Spændingsfrekvens
50/60 Hz, magnetfelt 3 A/m 3 A/m
EN/IEC 61000-4-8
Vejledning og producentens erklæring – Immunitet
LED Light Fiber er beregnet til brug i elektromagnetiske miljøer som angivet nedenfor.
Kunden eller brugeren af LED Light Fiber skal sikre, at den anvendes i et sådant miljø.
Immunitetstest EN/IEC 60601-testniveau Overensstemmelsesniveau Elektromagnetisk miljø - Retningslinjer
Induceret RF 3 Vrms, 150 kHz til IR
80 MHz
EN/IEC 61000-4-6 (LED Light Fiber
forsynes med strøm fra
internt batteri)
RF-stråling 3 Vms, 80 MHz til 2,5 GHz 3 V/m (E1)
EN/IEC 61000-4-3
Gulvene skal være af træ, beton eller keramiske fl iser. Hvis gulvene har
syntetisk belægning, skal den relative fugtighed være mindst 30 %.
IR
Magnetfelter genereret af spændingsfrekvenser skal svare til, hvad der
er normalt for et typisk erhvervs- eller hospitalsmiljø.
Bærbart og mobilt RF-kommunikationsudstyr må ikke anvendes tættere på
LED Light Fiber end de beregnede afstande angivet nedenfor.
Anbefalet separationsafstand
d = 1,2√P 80 MHz til 800 MHz
d = 2,3√P 800 MHz til 2,5 GHz
Hvor P er den maksimale udgangseffekt af senderen i watt og d den
anbefalede separationsafstand i meter.
Feltstyrker fra faste sendere, som fastslået ved en elektromagnetisk
feltundersøgelse, skal være mindre end overensstemmelsesniveauet (E1).
Interferens kan forekomme i nærheden af udstyr, der indeholder en sender.
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