W A R N I N G S A N D C A U T I O N S
1.
A licensed health care practitioner must select the length of use and frequency of use depending on
individual patients needs. DO NOT use this device if a prescription has not been provided to you or if
you do not understated the prescription as this may result in injury.
2. Follow all precautions necessary to avoid electrical shock, fire, burns, or other personal injury from
electrical power by using the device indoors, with dry hands, in a dry location. Keep all electrical
connections away from water. Extreme care must be taken when using any cold therapy system.
Any cold products may cause injuries, e.g. burns, blisters, frostbite, swelling, discoloration and skin or
tissue necrosis if improperly used or monitored.
3.
Patient skin condition checks must occur every 1~2 hours on a routine basis. Caution must be taken
by routinely monitoring the patient during use on children, elderly, incapacitated patients, severe
cardiovascular diseases, those with decreased skin sensitivity or circulation due to poor nutrition,
medications (e.g. beta blocker or epinephrine, narcotics), tobacco and alcohol use. If such monitoring
is to occur outside the presence of the licensed healthcare professional, he or she must ensure that
the patient or patient caretaker understands how such monitoring is to be conducted.
4. If redness, itching, numbness, burning, pain or tingling increases, or unusual reactions like blisters,
discoloration, swelling, welts, or other changes in skin appearance occur while using this product,
consult your medical professional immediately.
5. DANGER - Risk of explosion if used in the presence of flammable anesthetics or oxygen rich
environment.
6. To reduce the risk of electrical shock, do not disassemble unit. Return to manufacturer per Warranty.
7.
Do not allow fluid to come into contact with the power connection on lid.
8. Only use power supply provided with unit. Failure to follow instructions could damage the pump,
power supply or both.
9. The product is not suitable for use in contact with foods and beverage.
10. Dispose cooler and lid according to local, state and federal regulations.
11. Keep power cord, hose, small parts and packaging materials away from small children and animals.
These items pose a risk for suffocation or strangulation.
12. It could be unsafe to use accessories, detachable parts and materials, or interconnect to other
equipment not described in these instructions, or otherwise modify equipment.
13. Care must be taken when operating this device adjacent to other equipment. Potential
electromagnetic or other interferences could occur to this or other equipment. Try to minimize the
interference by not using other electronic equipment in conjunction with this device.
14. The power supply unit is the mains power disconnect. Do not position the equipment to make
access to the disconnect difficult.
15. It is recommended that at least 20 minutes of cessation should be encouraged between 2 hour long
cryotherapy sessions.
16. When applying the device wrap to the skin, apply a barrier (e.g. cloth or bandage) between the wrap
and your skin, and do not wrap it around the area tightly. No part of the wrap should touch the skin
for any period of time.
17. The treatment site should be kept dry. Check for moisture on the barrier between your skin and cold
pad. If moisture is present on the barrier, immediately discontinue use of this device.
18. Ensure to speak with your healthcare provider prior to use if you suffer from Buerger's disease, suffer
from a condition that may decrease your skin sensation, such as peripheral neuropathy, sciatica,
stroke or spinal cord injury, if you are taking medication that may negatively impact on peripheral
vascular circulation (e.g. beta adrenergic blockers and local epinephrine) or, if you have a history of
frostbite or adverse reactions to local cold application.
This device adheres to the following standards: IEC60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-1-11,
IEC62366.
WARNINGS AND CAUTIONS
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