Device Description; Contraindications - Medtronic NuVent 1830717FRT Bedienungsanleitung

EN
Indications for use
The NuVent EM Sinus Dilation System is intended for use in sinus procedures when surgical
navigation or image-guided surgery may be necessary to locate and move tissue, bone
or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and
sphenoid sinuses.
The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted
surgery system.
The Medtronic computer-assisted surgery system and its associated applications
are intended as an aid for precisely locating anatomical structures in either open or
percutaneous procedures. Their use is indicated for any medical condition in which the
use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical
structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized
landmarks of the anatomy.
The system and its associated applications should be used only as an adjunct for surgical
guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Device description

The NuVent EM Sinus Dilation System comprises sterile, single-use instruments that combine
electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects
of balloon dilation technology and an inflator. Each of the three types of sinus seekers
(frontal, maxillary and sphenoid) has a unique shape and angle that allows for entry into the
sinus outflow tract. The inflator consists of a plunger, barrel and extension tube.
Each sinus seeker is intended for use in conjunction with the Fusion software on a Medtronic
computer-assisted surgery system. Inside each sinus seeker is an EM tracker. The emitter on
the EM Computer-Assisted Surgery System generates a low-energy magnetic field to locate
the tracker mounted inside of the sinus seeker. The software displays the location of the
sinus seeker's tip within multiple patient image planes and other anatomic renderings. After
confirmation of placement, the sinus seeker's balloon can be inflated with saline solution by
using the inflator to expand the outflow of the targeted sinus.

Contraindications

None known.
Warnings
• The sinus seekers are fixed, rigid instruments that are not designed to bend. Do
not bend or alter the instrument, as navigational inaccuracy will occur.
• Do not open sterile barrier packages or containers until surgical use.
• Deflate balloon prior to removal from anatomy.
• Only use device in conjunction with an endoscope.
• Only use sterile saline as inflation solution.
• Do not reuse the seeker or inflator, as these are single patient use devices.
• Do not submerge the sinus seeker.
• Only use the sinus seeker in conjunction with Medtronic Inflator Part Number: 18INFKIT.
• Do not place metal objects in magnetic field.
• Do not use the sinus seeker to perforate thick bone.
• Use of the incorrect balloon size may cause damage to the sinus balloon and / or
surrounding anatomy.
• Use of an undersized sinus balloon may result in failure to properly treat the target
sinus.
• Prior to use, examine the product packaging for damage, deterioration, and expired
shelf life. Replace it with an unused system and contact Medtronic Technical Service.
• Only use device in conjunction with Medtronic computer-assisted surgery system.
• You must re-register the patient if you replace the EM ENT Patient Tracker during any
part of the procedure.
• Do not hold the seeker at the proximal end of the handle or apply excessive force to the
handle, as this may cause navigational inaccuracy. Refer to Figure 7.
Instruction for use
The NuVent EM Sinus Dilation System includes an inflator and a sinus seeker (Figure 1).
For proper operation, follow the proceeding instructions which cover inflator preparation,
priming, inflator/sinus seeker connection, and EM Computer-Assisted Surgery System.
Preparing the inflator
1. Inspect product packaging prior to use. Do not use product if packaging is damaged.
2. Remove the inflator tray from the sterile pouch and sterile tray.
3. Connect the extension tube to the Luer fitting of the inflator (Figure 2).
4. Fill sterile container with saline solution. Place the extension tube in the container.
Priming the inflator
5. With the inflator pointed up and the extension tube immersed in the saline solution,
prime the inflator by pulling and pushing on the inflator plunger, drawing saline
solution into and out of the inflator (Figure 3). Repeat at least five times to remove all air
bubbles from the extension tube and inflator.
6. Inspect the extension tube and inflator for air bubbles. If air bubbles are still present,
prime the inflator again. Repeat until air bubbles are no longer present in the inflator
and extension tube.
7. Remove the extension tube from the sterile saline solution and set the inflator aside
while preparing the sinus seeker.
NuVent EM Sinus Dilation System
EN
5