Safety Information; Storage Conditions; Directions For Use - Stryker ClariFix Gebrauchsanweisung

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ClariFix Instructions For Use
Infection
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Dry eyes, optical changes or orbital damage
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Frost-bite and/or cryolysis to surrounding area
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Delayed diagnosis due to change in pain perception or presentation on clinical or imaging
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assessment
For chronic rhinitis patients, transient increase in nasal congestion, dry nose and/or ear
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blockage/hearing loss
Continued or worsening symptoms
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Care should be exercised when treating thin tissue structures, as excessive freezing may cause
tissue damage.
Nosebleed is rare, but a potential side effect, and may be increased if the patient has a clotting
disorder, uncontrolled high blood pressure, or uses anticoagulants or blood thinners.

SAFETY INFORMATION

WARNINGS
This product is intended solely for use by medical professionals (physicians) trained in ENT
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procedures and navigating the nasal anatomy.
Carefully inspect the sterile package seal and device for any signs of damage prior to use. Do
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not use a device with a breached sterile seal as it could be contaminated. Do not use a damaged
device as it could malfunction.
DO NOT REUSE or RESTERILIZE. Reuse of the device may result in device malfunction. The
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device is intended for single patient use only.
After the cryogen canister is loaded, the cryoprobe is under high pressure.
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Any change to the construction of the device may cause a device malfunction leading to a
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potential injury to the user and/or the patient.
Never block the exhaust ports at the bottom of the cryoprobe handle.
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When replacing the cryogen canister, it is important to remove the cryogen canister slowly and
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to wait for at least one minute before loading another cryogen canister. This will allow the excess
nitrous oxide to completely vent from the handle and be released safely.
Do not discard pressurized cryogen canisters. Disposing of pressurized cryogen canisters could
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injure personnel if the canister is not emptied prior to incineration or other disposal methods. A
pressurized cryogen canister can explode at temperatures above 50° C (122° F).
The device is not intended for use in a Magnetic Resonance Environment.
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PRECAUTIONS
The cryogen canisters are provided non-sterile, attached to the bottom of the sterile cryoprobe
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tray. Use the sterile caps provided inside the tray with the cryoprobe to handle the non-sterile
cryogen canisters in a sterile field.
Always advance the ClariFix device under direct visualization. If desired, a rigid endoscope may
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be used to augment visualization in the nasal passageway.
Avoid moving the cryoprobe during treatment to ensure good contact with the target tissue is
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maintained and optimum treatment is achieved.
Allow the balloon to thaw before removing it from the target tissue to avoid unwanted tissue
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injury. Thawing is indicated by ice melting from the balloon and the distal tip of the cannula.
Minimal to no resistance should be felt when moving the balloon from tissue.
Keep orientation of the device within the range shown in Figure 5 to ensure proper nitrous oxide
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flow.
In accordance with the European REACH regulation and other environmental regulatory
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requirements, the ClariFix device contains internal brass components with lead.

STORAGE CONDITIONS

Store the device in a cool, dry place. Store the cryogen canisters in a controlled room temperature
environment that does not exceed 50
50° C (122° F).

DIRECTIONS FOR USE

Preparation
1. Remove the non-sterile cryogen canisters and place in a non-sterile/clean field.
2. Peel open the sterile packaging lid to remove the ClariFix cryoprobe & sterile caps. Place in the
sterile field, as appropriate.
3. Before beginning treatment, the target tissue should be thoroughly inspected to ensure
appropriateness for treatment. When applied to the target tissue, the balloon of the ClariFix
device freezes a circular area of tissue approximately 15-20 mm (0.6-0.8 inches) in diameter.
Freezing depth depends upon the time of treatment (i.e./ how long the valve is in the "open"
position).
° C. The cryogen canisters can explode at temperatures above
3