Breg Polar Care Wave Instrucciones De Uso página 3

INDICATIONS FOR USE
The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling,
and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed
healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
CONTRAINDICATIONS
The patient should NOT use the Polar Care Wave System if the patient is suspected of or observed to have
any of the following pre-existing conditions:
Cold and Compression Therapy:
• Significant vascular impairment in the
affected region (e.g., from prior frostbite,
arteriosclerosis, arterial insufficiency, diabetes,
vascular dysregulation, or other vascular
ischemic disease).
• Current clinical signs of inflammatory
phlebitis, venous ulcers, or cellulitis.
• Any significant risk factors or current clinical
signs of embolism (e.g., pulmonary embolus,
pulmonary edema, cerebral infarction, atrial
fibrillation, endocarditis, myocardial infarction,
or atheromatous embolic plaque).
Compression Therapy:
• Current clinical signs in the affected region
of significant peripheral edema (e.g., deep
vein thrombosis, chronic venous insufficiency,
acute compartment syndrome, systemic
venous hypertension, congestive heart failure,
cirrhosis/liver failure, renal failure).
• An acute, unstable (untreated) fracture in the
affected region.
• Any active local or systemic infection.
• Obtunded or with diabetes mellitus, multiple
sclerosis, poor circulation, spinal cord injuries,
and rheumatoid arthritis.
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• A condition in which increased venous or
lymphatic return is not desired in the affected
extremity (e.g., lymphedema after breast
cancer or other local carcinoma and/or
carcinoma metastasis in the affected extremity).
• Hypertension, cardiac failure, extreme low
blood pressure, or decompensated cardiac
insufficiency.
• Localized unstable skin condition (e.g.,
dermatitis, vein ligation, gangrene, or recent
skin graft) in the affected region.
• Had recent toe surgery in the affected region.
• Areas of skin breakdown or damage
(damaged or at-risk skin) producing uneven
heat conduction across the skin (e.g., open
wound, scar tissue, burn or skin graft). Any
open wound must be dressed prior to use of
the Polar Care Wave System.
• Presumptive evidence of congestive heart failure
• Pre-existing DVT condition
• Deep acute venal thrombosis
(Phlebothrombosis)
• Inflammatory phlebitis process
Contraindications continued through page 3.
CONTRAINDICATIONS
Compression Therapy (continued from page 2) :
• Episodes of pulmonary embolism
• Pulmonary edema
• Acute inflammation of the veins
(Thrombophlebitis)
• Decompensated cardiac insufficiency
• Arterial dysregulation
• Erysipelas
• Carcinoma and carcinoma metastasis in the
affected extremity
Cold Therapy:
• Known hematological dyscrasias that
predispose to thrombosis (e.g., paroxysmal
cold hemoglobinuria, cryoglobulinemia, sickle-
cell disease, serum cold agglutinins).
• Tissues inflamed as a result of recent injury or
exacerbation of chronic inflammatory condition.
• Compromised local circulation or neurologic
impairment (including paralysis or localized
compromise due to multiple surgical procedures
or diabetes) in the affected region.
• Cognition or communication impairments that
prevent them from giving accurate and timely
feedback.
• Raynaud's disease or cold hypersensitivity
(cold urticaria).
• Decompensated hypertonia in the affected
region.
• Raynaud's phenomenon or other vasospastic
conditions.
• Decompensated hypertonia
• Acute inflammatory skin diseases or infection
• Venous or arterial occlusive disease
• Medical situations where increased venous or
lymphatic return is undesirable
• Poor peripheral circulation
• Severe arteriosclerosis, or active infection
• Cold allergy
• Cold agglutinin disorders like paroxysmal cold
hemoglobinuria
• Buergers disease
• Chilblains
• Cryoglobulinemia
• Sickle cell anemia
• Diabetes
• Hypersensitivity to cold
• History of cold injury
• Severe cardiovascular disease, anesthetic
skin, hypercoagulation disorders, poor
circulation, extremities sensitive to pain,
extremely low blood pressure that are
incapacitated, decreased skin sensitivity,
vein ligation or recent skin grafts, or
pheochromocytoma.
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