InstaKool® Disposable Cold Packs Passes Test of Cold Duration
CRYOGENIC TESTING
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; 5.2.1.6 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.
RESULTS
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.
Research Professor
Microbiology Laboratory
Memorial Sloan-Kettering Hospital
(Data on File)
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