Safety Precautions - Össur COLD RUSH Instrucciones De Uso

ENGLISH

SAFETY PRECAUTIONS

WARNING: The Cold Rush
seriously injure skin. Read the instructions which are located inside the
unit, the instructions for the pad, and the labels on the device carefully
before operating the Cold Rush cold therapy system.
INTENDED USE AND INDICATIONS
• Provides cold therapy
• Indications requiring the application of cold therapy to a joint or limb
such as post-surgical, trauma pain, and swelling
CONTRAINDICATIONS
The Cold Rush Compact Cold Therapy Device should not be used on
patients with the following conditions:
• History of cold-related injury or adverse reactions to cold therapy;
• Unconsciousness or incoherence due to general anesthesia, sedation
or coma;
• Impairment of circulation or potential impairment of healing in the
treatment area, including infection;
• Circulatory disease, including Reynaud's disease, Burger's disease,
peripheral vascular disease, vasospastic disorders, sickle cell anemia,
or hypercoagulable clotting disorders; or
• Polyneuropathy or other nerve damage
WARNING: RX ONLY.
The device should only be used with a prescription from a physician that
includes the following treatment information: (1) the duration of the
entire cold therapy protocol, (2) the length of individual cold therapy
sessions, as well as the length of breaks from cold therapy treatment, (3)
setting of flow control knob, (4) instructions about how to inspect the
skin, and (5) frequency of skin checks.
WARNING: SKIN INSPECTION AND ADVERSE REACTIONS.
The patient or his healthcare provider must check the skin at least every
1-2 hours during use of this device, regardless of whether the patient is
asleep or awake. The patient must discontinue the use of the Cold Rush
Cold Therapy Unit if he experiences 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.
WARNING: NO DIRECT CONTACT WITH SKIN:
INSULATION BARRIER REQUIRED (not included).
The Cold Rush Pad should never make direct contact with the skin. An
insulation barrier between the pad and the skin should be used at all
times without exception in accordance with instruction from the
physician so as to prevent the skin from becoming too cold. The Cold
Rush pad operating temperature is too cold to be placed directly on the
skin.
• Unit is not suitable for use in the presence of flammable anesthetic
mixture with air, oxygen or nitrous oxide.
• Follow local ordinances or regulations for proper disposal of device,
cold therapy system can be cold enough to
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