DIRECTIONS FOR USE

  • The Zeroº Collar should be stored at room temperature and in a dry environment.

  • Remove the Zeroº Collar from the package.

  • Lay the Zeroº Collar flat on the ground or other hard surfaces with labeled side up.

  • With a closed fist, gently strike the Zeroº Collar at the 4 indicated spots top break open the water pouches and activate the cooling process.  If a water pouch does not break open, strike it again slightly harder.  Use of excessive force may cause the collar to leak.

  • Vigorously shake for 10 seconds to activate cooling.

  • Ensure that all 4 compartments are getting cold before applying the Zeroº Collar.

  •  Zeroº Collar is designed to be placed on neck with the two ends meeting at the front of the neck.  A 1.5″ gap between ends is acceptable.

  • The down arrow should be placed at the back of the neck.

  • Secure the Zeroº Collar snugly around the neck  with the included velcro strap.  Do not position the Zeroº Collar over the mouth or nose

  • Always monitor the patient after application of the collar to ensure that:

    1. The cold is not causing damage (frostbite or ice burn)

    2. Zeroº Collar is not too tight that it impairs breathing

    3. Zeroº Collar is not too tight to that it affects normal blood flow

  • Discontinue use if you develop an adverse reaction to the application of the Zeroº Collar.

  • Consult a physician if symptoms worsen or persist.

  • The Zeroº Collar is a single use device.  After use dispose of with household waste.

SAFETY INFORMATION

  • Activate the ZEROº Collar and check to make sure all compartments become cold. 

  • Do not use a shoe, hammer, or board or other tool to strike the ZEROº Collar.  Excessive force may cause leaks in the external pouch. If a leak occurs, discard the device immediately.

  • Do not attempt to activate the collar if it is already around a patients neck.

  • Always monitor the patient after placement of the ZEROº Collar to ensure that:

    1. The cold is not causing damage such as frostbite or ice burn.

    2. The ZEROº Collar is not too tight (that it affects normal blood circulation).

  • Store at room temperature prior to use. Allowable storage range is -18 to 50 degrees C  (0-120 degrees F).

  • The ZEROº Collar should be between 10 and 27 degrees C (50-80 degrees F) prior to activating

  • Do not refrigerate or freeze prior to use.

  • The ZEROº Collar is a single use device. Do not re-use. Do not simultaneously apply more than one collar to a patient.

  • The patient side (unlabeled side) of the Zeroº Collar should be dry and applied to dry skin.  If the device or neck is wet prior to application, rapid cooling may cause damage to skin.

  • CAUTION: To avoid skin or tissue damage a maximum safe period for application of 60 minutes is recommended.

  • The most effective duration of application of the ZEROº Collar appears to be 20 to 30 minutes or until the collar no longer provides significant cooling.

  • The ZEROº Collar should not be used without direct supervision of anyone who is mentally impaired or incapacitated.

  • The ZEROº Collar should not be used on infants.

  • Do not use the ZEROº Collar if it is leaking, torn, damaged, or punctured.

  • For external use only . Seek medical attention in case of an accidental exposure to the contents of the ZEROº Collar. In the event of contact with pack contents, wash affected area with soap and water.

  • If contents are ingested, consult a physician.

  • Keep away from open flame, harsh chemicals, or solvents.

  • Never attempt to use as a heat pack or re-heat in a microwave oven.

  • All directions are considered guidelines and not an attempt to define medical practice.

PUBLICATIONS

See below some of the latest research supporting mild hypothermia as a treatment for  concussions:

MATERIALS

This device may contain one or more of the following:

  • polyvinyl chloride (PVC) (CAS#: 9002:86-2)

  • polyester (CAS# 113669-97-9)

  • nylon (CAS#: 9012-28-6)

  • polyethelene(LDPE) (CAS#: 6484-52-2)

  • water (CAS#: 7732-18-4)

WARRANTY / REFUND  POLICY

The manufacturer warrants this product to be free from defects in workmanship and materials, under normal use and conditions, and based on the instructions provided, for a period of one (1) year from the original invoice date. All shipping and handling fees are to be paid by the customer. The manufacturer agrees, at its option, during the one (1) year warranty period, to repair any potential or actual defect in workmanship or materials, or to furnish a repaired or replacement product of equal value in exchange without charge (except for shipping and handling fees, which are to be paid by the customer). This warranty does not include (1) any condition not resulting from normal use and conditions, or any condition not based on instructions provided, (2) normal wear and tear, or wear and tear caused by the customer or other third parties, (3) any conditions resulting from use for which the product was not intended, (4) any condition resulting from incorrect or inadequate care by the customer or third parties, and (5) damage resulting from misuse, abuse, negligence, accidents or shipping damage, caused by the customer or third parties, which is the customer’s responsibility. For refunds/returns, please email TalusRandD@gmail.com or call 970.309.7148.

 

LIMITATION OF LIABILITY:

The customer understands and agrees that if Talus Research + Design, LLC  (the "manufacturer") should be found liable for any loss or damages due from a failure to perform any of its obligations or a failure of the equipment to properly operate, the manufacturer's liability shall be limited to a sum of five hundred dollars ($500) , and this liability shall be exclusive and shall apply if loss or damage, irrespective of cause or origin, results directly or indirectly to persons or property from performance or non-performance of any of the manufacturer's obligations or from negligence, active or otherwise, of the manufacturer, its employees or agents.

Zero Degree Collar will be registered as a Class 1 medical device with the FDA in 2021.

 
 
 
 

RAY PASCHAL, Founder & CEO
TalusRandD@gmail.com
970.309.7148 Mobile

16706 HWY 82 Carbondale, CO 81623

©2019 Talus Research + Design, LLC. Zero°Collar. All rights reserved.