Cryogenic Therapy has been long used as a modality to treat various medical applications/indications such as such; strains, sprains, contusions, headaches, minor bleeding and burns.
This study was performed by Annamalai Selva Kumar, PhD. of Memorial Sloan-Kettering Hospital to determine whether the InstaKool® Disposable Cold Packs were able to meet ANSI Standards on cold applications based on acceleration to meet a cold temperature, then remain at that temperature for 15 minutes without dropping below 20° F. InstaKool® meets the standard established by ANSI on both the Junior and Large sizes.
Samples of the cold packs were supplied to a clinical researcher, Dr. Selva Kumar, PhD, Research Microbiology Lab, Memorial Sloan Kettering Hospital, who performed the ANSI testing. The initial and long term effect was to ensure the length of time and expediency of cold to specific parameters set forth by ANSI.
ANSI Z308.1-2003; 188.8.131.52 Cold pack: Each cold pack shall be at least 4X% in. (10 X 12.5 cm) in size and shall reach a temperature between 20 – 40° F (-6 -4° C) within 10 seconds of activation. The cold pack must maintain a temperature between 20 – 40° F (-6 -4° C) for a period of at least 15 minutes. Cold packs shall activate under normal hand pressure and shall not leak under normal conditions of use.
Testing for both the Junior 5″ x 7.5″ and Large 6″ x 8.75″ sizes were tested and exceeded the ANSI recommendation by two (2) times. The kit size 5″ x 6″ exceeds the ANSI testing just over 20 minutes. All three sizes were able to reach the cold limits faster than 10 seconds.
Finally, non-perforated water bag testing was done to ensure the “release point” or “break point” under normal hand strength without leaking.
InstaKool® is designed to meet and exceed ANSI requirements. Due to the combination of ingredients, package geometry, material composition (non-perforated water bag) of the inner and outer pouches of the InstaKool® over time exceeds the standards set forth by American National Standard and the FDA for non-regulated medical devices.
Annamalai Selva Kumar, PhD.
Memorial Sloan-Kettering Hospital
(Data on File)
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