Product Description; Indications For Use; Intended Purpose - Össur COLD RUSH Instrucciones De Uso

PRODUCT DESCRIPTION

Cold Rush is a mechanical circulation cold therapy device. The device is
composed of a bucket holding a mixture of water and ice, a circulation
pump that forces the coolant through a closed-loop hydraulic circuit and
a cooling pad that is used to apply cold therapy to the region that is
being treated. The system operates on a 12-volt power which is supplied
via an external wall-mounted power supply.
LIST OF PARTS (Figure 1)
• Cold Rush Cold Therapy System
• Hose
• Couplings
• Flow Control Knob
• DC Connector
• 12V Power Supply
• Cold Rush Pad (Sold Separately)

INDICATIONS FOR USE

• 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 Cold Therapy device should not be used on patients with
the following conditions:
• Known hematological dyscrasias that predispose to thrombosis
(e. g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sickle cell
disease, serum cold agglutinins)
• Compromised local circulation (including arteriosclerosis, ischemia)
• Neurologic impairment (including paralysis or localized compromise
due to multiple surgical procedures or diabetes) in the affected
region, polyneuropathy, or other nerve damage causing decreased
skin sensitivity
• Cognition or communication impairments that prevent the user/
patient from giving accurate and timely feedback including
incapacitated patients with severe cardiovascular disease, anesthetic
skin, hypercoagulation disorders, poor circulation, extremities
sensitive to pain, extremely low blood pressure
• Raynaud's disease, phenomenon, or other vasospastic conditions
• Buerger's disease, significant vascular impairment
• Hypersensitivity to cold (cold urticaria) or history of cold related
injury (including chilblains or frostbite)
• Severe cardiovascular disease, anesthetic skin, hypercoagulation
disorders, poor circulation, extremities sensitive to pain, extremely
low blood pressure, incapacitation, decreased skin sensitivity, vein
ligation or recent skin grafts, or pheochromocytoma
• Localized unstable skin condition (e. g., dermatitis, vein ligation,
gangrene, or recent skin graft) in the affected region or potential
impairment of healing in the treatment area, including infection
• Tissues inflamed as a result of recent injury or exacerbation of
chronic inflammatory condition

INTENDED PURPOSE

The Cold Rush is a non-invasive device, intended for single patient use
and designed to reduce localized pain and swelling following surgical
procedures or trauma.
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