Entellus Medical XprES Instrucciones De Uso página 5

Note: Do not exceed 12 atm.
Warning: T o avoid barometric trauma to tissue, do not use device in suction mode (remove finger from
suction vent, disconnect suction hose from device, or clamp suction hose) while balloon is
inflated.
c. When using the 8 mm length balloon, multiple inflations may be needed in order to achieve the desired
result. Partially retract the balloon slide mechanism between inflations using the 5 mm handle reference
marks to ensure full length treatment. See Figure 12.
Figure 12: Handle Marks for 8mm Length Balloon
d. Deflate the balloon by retracting the Inflation Syringe plunger rod to the second click position and retracting
the XprESS balloon slide mechanism. Observe the results endoscopically.
e. Perform additional inflations if needed until desired result is achieved.
Note: T o irrigate the sinus, fill a 20-30 mL syringe with sterile saline. Connect the syringe to a flexible
Extension Line and purge air. Connect Extension Line to proximal barbed fitting and flush through
suction/irrigation lumen as desired. The suction vent does not need to be covered during irrigation.
1. Remove device from treatment site: When the sinus outflow tract or Eustachian tube has been adequately
dilated, deflate the balloon (by retracting the Inflation Syringe plunger rod to the stop position), retract the
XprESS balloon slide mechanism, and remove the XprESS device from the treatment site.
2. If necessary, clean up the ostium site by cutting or removing flaps of tissue, fragments of exposed bone, or
any other bone and mucosa that may obstruct or otherwise prevent ventilation and drainage of the sinus.
3. Repeat the same procedure to treat additional spaces if desired.
4. After completing the entire procedure, dispose of the devices and all waste products according to appropriate
environmental health safety guidelines.
How Supplied
The XprESS ENT Dilation System is provided sterile and is 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 breached or damaged packages, since the sterility and functionality of the device may be compromised.
Limited Warranty
Refer to Entellus Medical, Inc. Standard Terms and Conditions.
INSTRUCTIONS FOR USE
PathAssist™ LED Light Fiber™
Read all Instructions prior to use
Caution:
Federal (USA) law restricts this device to sale by or on the order of a physician.
Sterility: Provided Sterile, Ethylene Oxide (EO) Sterilization
Single Use: Disposable, For Single Patient Use Only, Do Not Resterilize and/or Reuse
Storage: Store in a cool, dry place. Do not expose to high temperatures above 50°C (122°F).
Indication For Use
To locate, illuminate within, and transilluminate across nasal and sinus structures.
Description
The PathAssist LED Light Fiber is a single use, disposable, flexible instrument that emits light from the distal end.
The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light
source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes.
It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").
Figure 1 LED Light Fiber
The LED Light Fiber is packaged alone or may also be packaged with XprESS (LoProfile or Ultra Suction Tips).
Contraindications
None known
Warnings
Specifications
Item
Weight
Nominal working length of fiber
Fiber outer diameter
Light source (red LED)
Activation time
Battery type
Power source
Maximum LED output power for treatment
Mode of operation
Safe operating ambient temperature range
Safe storage and transport temperature range
Safe operating, storage, & transport relative humidity range
Complies with medical safety standards:
Complies with medical EMC standard:
•
Do not use breached or damaged packages, since the sterility and functionality of the device may be compromised.
•
Single use only. Do not re-sterilize or re-use, as it may result in compromised device performance and risk
improper sterilization and cross contamination.
•
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 LED Light Fiber in a sinus that is not
adequately developed.
•
Never advance or withdraw the device against unknown resistances as this can cause tissue trauma or
device damage.
•
Do not rest the device on the patient during surgery while it is activated, as this could result in burns to the patient.
•
No modification of this device is allowed.
Precautions
○ Due to the variability of sinus anatomy, review radiographic imaging (CT scan) prior to the procedure.
○ Do not kink the LED Light Fiber as this may damage the device.
○ Be sure to pre-load the fiber into the XprESS device prior to shaping it into a maxillary bend configuration (i.e.,
approximately 135º bend) as the fiber will not load when XprESS is pre-shaped in a maxillary configuration.
○ Wait to activate the LED Light Fiber just prior to use as once activated the fiber will emit continuous light for
over 60 minutes. There is no on/off switch.
○ Do not stare directly at LED Light Fiber tip, or point it directly at anyone's eyes while illumination is active.
○ Do not use the device for external transillumination of maxillary sinus by applying the device to the hard palate,
as this use has not been tested.
○ Do not incinerate the device except for disposal in a controlled incinerator.
Adverse Effects
Possible adverse effects include, but are not limited to, the following:
•
Cerebrospinal fluid leak
•
Damage of the orbital wall or other structures of the eye
•
Tissue inflammation or trauma
Compatibility
The device is compatible with the XprESS ENT Dilation System (all suction tip sizes)
Please refer to the XprESS ENT Dilation System Instructions for Use for detailed information and instructions
on the use of XprESS.
Instructions for Use
NOTE: Steps 1-3 are only necessary if LED Light Fiber is packaged alone. If LED Light Fiber is packaged
with XprESS device, go to STEP 4.
1. Remove the LED Light Fiber from the protective packaging.
2. Load the fiber into the working lumen of XprESS (Figure 2).
3. Attach the LED Light Fiber housing to the barbed fitting of the XprESS device (Figure 3). Align the distal tip
of the fiber with the distal end of XprESS (Figure 4).
Figure 2
4. Shape loaded XprESS to desired bend configuration for targeted sinus.
5. Activate the LED Light Fiber by removing the pull tab. Confirm that light is being transmitted through the LED
Light Fiber.
6. Under endoscopic visualization, place the loaded XprESS device into the target location to illuminate within
and transilluminate across nasal and sinus structures.
- Projected illumination can be enhanced by slightly advancing tip of the LED Light Fiber distal from the
XprESS device.
7. After procedure, dispose of device according to Federal, state, and local regulations, and appropriate
environmental health safety guidelines. Do not incinerate except for disposal in a controlled incinerator.
Specification
< 40 grams
27.6cm
0.375mm (0.015").
625nm wavelength
Over 60 minutes
Lithium manganese dioxide, CR2, 3Volts
Internally powered
1 W
Continuous
15 - 33°C (59 - 91°F)
-10 - 50°C (14 - 122°F)
0 – 95% RH
IEC 60601-1:2005/AMD 1:2012; CAN/CSA-C22.2 No. 60601-1:2014
IEC 60601-1-2:2014; Type BF applied part
5
Figure 3
Figure 4