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Directions For Use

for individual patients - Directions For Use

For Individual Patients

If you were provided a unit by a dental professional, refreeze and reuse as directed.

If you purchased your unit online, follow the Instructions for Use on the package and the directions listed below.

for dental offices - Directions For Use

For Dental Offices

A box of 4- or 8- units will arrive at room temperature. Each mouthpiece is vacuum sealed and packaged individually with a cleaning brush, an insulated sleeve, and Instructions For Use. You can store unopened units at room temperature. Units should not be shared between patients. Before using Denta-Cool™ with a patient after a surgery, freeze the unit for at least 6 hours.

Indications

Denta-Cool™ mouthpiece is an intraoral cryotherapy device intended to help reduce swelling and discomfort.

Note: Unit will arrive double sealed; a vacuum sealed bag inside a resealable vacuum sealed bag. Save the resealable bag for future storage.

Composition

  1. The device is made of FDA medical grade silicone, filtered water, and saline.
  2. Center blue core (inside chamber) is filled with filtered water. Center core freezes solid in the freezer (standard freezer temperature 0 °F / – 18 °C).
  3. Outside chamber is filled with saline. Saline freezes solid at lower temperature than filtered water (approx. – 6 °F or lower). Therefore saline in the outside chamber remains liquid even if the device is stored in the freezer. This way the mouthpiece feels flexible when you place it in the mouth.

Instructions for Use

  1. Prior to first use, place unopened unit in the freezer for at least six (6) hours to freeze the center core.
  2. When center blue core is frozen solid, unit is ready for use.
  3. Remove unit from packaging and slide insulated sleeve over the base.
  4. Fit mouthpiece chamber into mouth and place your lips over the raised edge. (Figure 1)
  5. Unit has breathing tubes to allow normal breathing.
  6. Tilt head back while in use and squeeze the base/insulated sleeve every few minutes to keep cold water circulating inside.
  7. After your cryotherapy session, clean the device (following the cleaning instructions) and return to the freezer. Freeze unit until the center core freezes solid before reapplying (check every 30 minutes).

Note: Safe to apply directly to mouth surfaces. Don’t use cover or towel like you would with an external ice pack.
The unit may produce condensation and the insulated sleeve might become damp while in use.

Figure 1.
denta cool figure 1 - Directions For Use

Cleaning, Care and Reuse

  1. After use, remove the insulated sleeve and clean the mouthpiece with soap and hot water. Use the supplied cleaning brush to clean inside the breathing tubes with soap and hot water. Note: If you have non-intact skin, you can also use an antibacterial denture cleanser to clean the unit.
  2. After cleaning, allow the unit to dry and place back into the resealable bag. Store in the freezer between uses. The device must be refrozen within 24 hours after use and must always be stored in the freezer.
  3. The device is ready for use any time for up to 24 months if stored properly in the freezer.

Storage

Device can be stored at room temperature in unopened vacuum sealed packaging for up to 24 months.

Product Disposal

Device can be disposed of in ordinary municipal waste. Please adhere to the applicable local regulations for disposal.

WARNING: DO NOT USE IF UNIT IS LEAKING OR THE ENTIRE UNIT IS FROZEN SOLID. BITING ON THIS DEVICE MAY CAUSE IT TO FAIL FOR ITS INTENDED USE. DO NOT BOIL OR PUT IN THE DISHWASHER TO CLEAN THE DEVICE.

DO NOT USE if packaging is damaged.

PLEASE CONSULT WITH A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL REGARDING ANY MEDICAL OR HEALTH RELATED QUESTIONS OR CONCERNS YOU MAY HAVE PRIOR TO USE OF OUR PRODUCTS.

how to clean - Directions For Use

HOW TO CLEAN

After each use, clean the unit with soap and hot water. Use the supplied brush to clean inside the breathing tubes.

ATTENTION: If you have open sores (non-intact skin) inside your mouth, use an antibacterial denture cleanser with soap and hot water to clean the unit.

how to store - Directions For Use

HOW TO STORE

After use, clean the unit according to directions, dry and place it back inside the freezer bag.

Store the unit in the freezer. It is ready for use any time for up to one (1) year.

 
 

NOTE: Please be aware unit MUST be refrozen within 24 hours after use and stored back into the freezer.
Unused unit can be stored in unopened packaging at room temperature for up to one (1) year.
DO NOT USE IF THE UNIT IS LEAKING OR THE ENTIRE UNIT IS FROZEN SOLID.