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THIS DEVICE CAN BE COLD ENOUGH TO CAUSE SERIOUS INJURY. SERIOUS
ADVERSE REACTIONS AND SAFETY HAZARDS MAY OCCUR WHEN USING THIS
DEVICE.
INDICATIONS FOR USE
When to use the IceMan® CLEAR
& CLEAR
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The intended use of the IceMan® CLEAR
temporary reduction of swelling and pain after surgery or injury . This is a non-
sterile prescription device for single patient use to provide localized external
application of cold therapy . This device may not be used for any other purpose .
CONTRAINDICATIONS
When not to use the IceMan® CLEAR
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DO NOT use this device on patients with Raynaud's phenomenon or other
vasospastic conditions; Buerger's disease; cold allergy or hypersensitivity;
cryoglobulinemia; paroxysmal cold hemoglobinuria or other cold agglutinin
disorders; pheochromocytoma; sickle cell anemia or history of cold injury .
LIMITATIONS ON SPECIAL PATIENT POPULATIONS
Limit the use of the IceMan® CLEAR
Limit the use of this device with patients who are unresponsive, incapacitated,
have altered mental status or altered pain perception . Post-surgical patients
under sedation or on analgesics or anesthetics, as well as patients taking hypnotics,
anxiolytics, or antidepressants, must be monitored frequently during use of this
device . These patients may not be able to perceive pain, burning, numbness,
tingling or decreased sensation and may be susceptible to injury . Discontinue
cold therapy immediately at the first sign of cold injury .
+
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and IceMan® CLEAR
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+ is for the
& CLEAR
+
3
& CLEAR
+ with these patients
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