Product Description; Indications For Use; Potential Adverse Effects - Stryker ClariFix Instrucciones De Uso

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ClariFix Instructions For Use
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of a physician.

PRODUCT DESCRIPTION

The ClariFix device is a handheld cryotherapy device, which provides focal, controlled freezing to the
target tissue. A nitrous oxide canister is loaded into the cryoprobe as a source of cryogen. The balloon
is placed in contact with the target tissue, under direct visualization. The low profile semi-flexible
cannula allows the user to maintain visibility of the balloon and apply pressure to target tissue with the
cryoprobe to ensure contact throughout the treatment. Once the balloon is in the desired position, the
physician manually initiates the flow of cryogen using the valve on/off button and ablates unwanted
tissue. The nitrous oxide gas is contained within the cryoprobe and exits out of the exhaust ports at
the bottom of the handle.
The ClariFix device is designed for single patient use. The cryoprobe is provided sterile. The cryogen
canisters (10 mL) are provided non-sterile and contain enough cryogen for 60 seconds of treatment.
Sterile caps are provided to load and unload the cryogen canisters for use in a sterile field. The
cryoprobe and caps are sterilized using irradiation.
CONTENTS
The ClariFix device consists of:
1 Cryoprobe (provided sterile)
2 Caps (provided sterile)
2 Cryogen canisters (provided nonsterile)
NOTE: The ClariFix device, components and packaging are not made with natural rubber latex.

INDICATIONS FOR USE

US: The ClariFix device is intended to be used as a cryosurgical tool for the destruction of unwanted
tissue, including in adults with chronic rhinitis.
International: ClariFix is a cryotherapy device intended to be used for the ablation of tissue in the nasal
cavity in patients with chronic rhinitis symptoms.
CONTRAINDICATIONS
The ClariFix device is contraindicated in patients with the following conditions:
Cryoglobulinemia
•
Paroxysmal cold hemoglobinuria
•
Cold urticaria
•
Raynaud's disease
•
Open and/or infected wounds or other skin conditions at or near the target tissue
•
Patients with diabetes, sensitivity to cold, neuropathic disorders, bleeding disorders, or impaired
•
peripheral circulation in the area to be treated should be treated with caution

POTENTIAL ADVERSE EFFECTS

Patients may experience one or more of the following adverse effects related to cryotherapy and/or
local anesthesia. Adverse effects may be mild or transient in nature and self-resolving:
Bleeding
•
Crusting and/or tissue sloughing
•
Pain/discomfort and/or facial pain
•
Swelling
•
Intranasal scarring/nasal obstruction
•
Sensory alterations (numbness, tingling) in the face/mouth
•
Headache
•
Septal perforation
•
Vasovagal reaction
•
Figure 1: ClariFix Device
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