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Donjoy IceMan CLEAR3 - Indications for Use; When to use the IceMan; Operating Principle; Intended User Profile

Donjoy IceMan CLEAR3
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2
When to use the IceMan®
The intended use of the IceMan® CLEAR
, IceMan® CLASSIC, and
IceMan® CLASSIC
is for the 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.
INDICATIONS FOR USE
THIS DEVICE CAN BE COLD ENOUGH TO CAUSE SERIOUS INJURY.
SERIOUS ADVERSE REACTIONS AND SAFETY HAZARDS MAY OC-
CUR WHEN USING THIS DEVICE.
The intended user should be a licensed medical professional, the patient,
the patient’s caretaker, or a family member providing assistance. The
user should be able to:
· Read, understand and be physically capable to perform all the direc-
tions, warnings and cautions provided in the information for use.
INTENDED USER PROFILE
The DonJoy® IceMan® devices provide cold therapy by flowing cold wa-
ter, from an ice bath through an applied therapy pad.
OPERATING PRINCIPLE