Medtronic NuVent 1830717FRT Bedienungsanleitung Seite 6

EN
Connecting the sinus seeker to the EM computer-assisted surgery system
8. Surgeon should use patient CT scan (hard copies or on Medtronic computer-assisted
surgery system) to determine the correct balloon size based on the bony margins of the
outflow tract.
9. Remove the tray from the sterile pouch.
10. Place the tray on the sterile preparation surface with the connector and connecting wire
on top.
11. Without separating trays, remove the connector and connecting wire from the top tray
(Figure 4).
12. Prior to use, examine the connector and cable for damage and deterioration. Do not use
product if damaged.
13. Insert the connector to the EM Computer-Assisted Surgery System and unwrap wire.
14. Remove the top tray.
Connecting the sinus seeker to the inflator
15. Grasp the sinus seeker handle in the recessed area indicated by the two arrows on the
tray and remove sinus seeker from the bottom tray (Figure 5).
16. Connect the extension tube to the luer fitting of the sinus seeker (Figure 6).
Checking the sinus seeker/EM computer-assisted surgery system recognition
17. Confirm that the fusion software displays the correct sinus seeker.
18. Prior to use, confirm accuracy of the sinus seeker by touching the tip of the sinus seeker
to several bony anatomical landmarks and observing the cross hairs on the monitor.
19. If accurate, proceed with navigation.
20. If accuracy is not acceptable, visually inspect the seeker. If the seeker is bent or
damaged, replace the sinus seeker and contact Medtronic Technical Services. If accuracy
is still not acceptable with a new seeker, re-register the patient.
For additional information about the Fusion software, refer to the Fusion ENT Pocket Guide
(9734349).
Dilating the sinus ostia
21. Hold seeker at the distal end of the handle (Figure 8). Do not use excessive force.
22. Insert the prepared sinus seeker into the desired anatomical location using an
endoscope and EM navigation. The probe description and balloon diameter will be
displayed on the Fusion software.
23. Confirm the proper positioning of the tip of the sinus seeker using EM navigation. The
cross hairs on the screen indicate the sinus seeker's tip.
24. Squeeze the inflator plunger into the inflator over the course of at least two seconds
until the inflator indicator protrudes (Figure 9). Hold inflation for up to five seconds. This
action inflates the balloon to approximately 10 atm (Figure 10). If the indicator does not
protrude, prime the inflator again.
25. Upon completion of up to two dilations per sinus ostium, deflate the balloon before
removing the sinus seeker from patient's anatomy by pulling back on the inflator handle
until it stops.
Note: Only remove the sinus seeker when the balloon is completely deflated.
26. Balloon may be wrapped with a gentle twisting motion to reduce its profile before re-
insertion (Figure 11).
27. Prime the inflator again when changing sinus seekers.
Sterilization
Discard the seeker, inflation device and extension tube after use in accordance with all
applicable regulations.
The NuVent EM Sinus Dilation System and the NuVent Inflator with Extension tube are
provided in a sterile condition and are single-use only. Do not reprocess, re-sterilize, or re-
use this device. Attempts to reprocess or re-sterilize the device may be ineffective and may
compromise its structural integrity. Any re-use creates a risk of contamination which could
result in patient injury, illness, or death.
International customer service
International customers should contact their local Medtronic Xomed office.
Note: When contacting Customer Services and Technical Support, please have the
appropriate product number, date of purchase, lot number, and nature of inquiry available.
Limited warranty
A. This LIMITED WARRANTY provides assurance for the customer who purchases a Medtronic
Xomed Product (hereinafter the "Product") that should the Product fail to function to
Medtronic Xomed's published specifications during the term of this LIMITED WARRANTY
(one year from the date of shipment for new Product, 90 days from date of shipment for
refurbished or used Product), Medtronic Xomed will either replace, repair, or issue a credit
(adjusted to reflect the age of the Product) for the Product or any portion thereof. This
LIMITED WARRANTY is extended only to the buyer purchasing the Product directly from
Medtronic Xomed or from its affiliate or its authorized distributor or representative.
B. To qualify for this LIMITED WARRANTY, the following conditions must be met:
(1)The Product must be used on or before its "Use By" or "Use Before" date, if applicable.
(2) The Product must be used in accordance with its labeling and may not be altered or
subjected to misuse, abuse, accident or improper handling.
(3)Medtronic Xomed must be notified in writing within thirty (30) days following discovery
of a defect.
6 NuVent EM Sinus Dilation System