Stryker ClariFix Instrucciones De Uso página 4

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ClariFix Instructions For Use
NOTE: Because both sides of the balloon will freeze during treatment, user discretion is required
to ensure appropriateness of the treatment area, including hollow structures. Freeze penetration
is on average 1 mm for every 17 seconds up to a maximum depth of 6 mm (see Figure 2).
Variability in tissue thickness may impact penetration of the treatment; thinner tissues may
require shorter treatment times.
4. Visualize the target treatment area and apply anesthetic. When
placing the device in the nasal passageway, endoscopic guidance is
recommended.
5. Load a cryogen canister into the cryoprobe handle and puncture it by
screwing the cryogen canister all the way down, ensuring the threads
are fully tightened.
NOTE: If using ClariFix in a sterile field, use one of the sterile caps
to grasp the non-sterile cryogen canister and load it into the device.
Balloon Placement
1. Rotate the cannula to the desired position by turning the rotator until
the cannula locks into place.
2. Place the balloon on target tissue. When using for chronic rhinitis
symptoms, insert the balloon and cannula into the nasal cavity and
advance until the balloon is located on the target tissue over the
branches of the posterior nasal nerve.
3. Ensure the balloon is in firm contact with the target tissue.
Treatment
1. Depress the valve on/off button to open the valve and activate the flow of cryogen. Maintain the
cryoprobe position on the target tissue.
Depress the valve on/off button all the way to engage the valve
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lock switch, locking the valve open. To release, push the valve
lock switch up.
NOTE: During treatment, cryogen gas will exit from the bottom of the
cryoprobe handle from the exhaust ports as shown in Figure 4.
NOTE: Throughout treatment, the cryoprobe orientation should be
maintained within the range depicted in Figure 5 to ensure proper
flow of cryogen from the canister. The flow of cryogen from the
canister to the balloon during treatment may be reduced if the
cryoprobe is not oriented correctly, thus reducing freezing at the
balloon.
2. As nitrous oxide flows into the balloon, the flow of cryogen can be seen through the formation of
ice and the balloon surface changing from translucent to white. Ice crystals should be observed
on the balloon and distal end of the cannula, and the visible portion of the target tissue will turn
white.
3. Keep the valve open as long as treatment is desired, using Figure 2 to estimate the depth of the
treatment over time.
4. Depending on the length of treatment, it is normal for the balloon to adhere to the tissue.
5. Close the valve and stop treatment by pushing the valve lock switch up and releasing the on/off
button to stop the flow of nitrous oxide at any time. If the valve is not closed, the treatment will
continue for approximately 60 seconds until the canister is empty. When used for chronic rhinitis
symptoms, deliver approximately 30 to 60 seconds of treatment.
Figure 2: Freeze area is restricted to the
surrounding tissue in contact with the
balloon.
Figure 5: Orientation of the ClariFix
cryoprobe to ensure proper flow of cryogen
from the canister.
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Figure 3:
Cap & Canister loading
Figure 4:
Cryogen gas exits
from the exhaust
ports on the bottom
of the cryoprobe.