• Follow local ordinances or regulations for proper disposal of device,
accessories, and packaging.
• CAUTION: Federal law requires this device to be sold by a physician
or by the order of a physician.
WARNING
Read the following treatment warning protocol instructions carefully
before operating the Cold Rush cold therapy system.
• The flow control knob should never be set at the maximum settings
(number "4" or "MAX") for more than 30 minutes.
• The Cold Rush pad should never be applied directly to the patient's
skin. Do not use the Cold Rush cold therapy system without first
applying an insulation barrier between the Cold Rush pad and the
patient's skin.
• Patients should never utilize cold therapy while they are asleep or
unable to check their skin every 1–2 hours unless specifically
instructed to do so by the prescribing health care provider.
• Patients must check their skin every 1–2 hours once steady flow of
water through the pad is achieved. Turn the flow control knob
counterclockwise to increase the temperature (warmer), and
clockwise to decrease the temperature (colder).
• When turning the unit on, turn the flow control knob clockwise to the
number "3" setting wait 10 minutes to allow the temperature to
stabilize before making any additional temperature adjustments.
• The following patients should ALWAYS turn the flow control knob
counterclockwise to the number "1" setting when using cold therapy
– Patients whose treatment area has been desensitized due to local
anesthesia or regional nerve blockers
– Patients taking prescribed medications that may negatively affect
peripheral vascular circulation, including beta adrenergic blockers
and local epinephrine use (such as in local anesthetics)
– Patients taking prescribed medications that negatively affect their
mental capacity or judgment
– Patients suffering from diabetes
– Patients who have recently undergone hand/wrist or foot/ankle
surgery
– Patients suffering from cognitive disabilities
– Young children and the elderly
• CAUTION: Contact your healthcare provider immediately and
discontinue the use of your Cold Rush Cold Therapy Unit if you
experience any adverse reaction to the treatment area such as:
increase in pain, burning, blistering, itching, increased swelling,
discoloration of the skin, increased redness, welts or any other
changes in the appearance of the skin.
• Make sure that the insulation barrier is dry.
• Care should be taken during prolonged use for children, diabetics,
incapacitated patients and those with decreased skin sensitivity or
poor circulation.
• A licensed healthcare practitioner must determine the correct
frequency and duration of treatment for each patient.
• If prescribed by a licensed healthcare practitioner for home use, the
healthcare practitioner must provide each patient with training for
appropriate use and proper application of the Cold Rush Cold Therapy
System.
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