FOR USE WITH
GAME READY GRPRO 2.1 SYSTEM
ABSOLUTE CONTRAINDICATIONS
Therapy in these situations should
not
be used
in patients.
Compression Therapy using the Game Ready
GRPro 2.1 System or any compression therapy
device should not be used in patients:
• Who are in the acute stages of inflammatory phlebitis in the affected region.
• Who have any current clinical signs suggestive of deep vein thrombosis in the
affected region.
• Who have significant arteriosclerosis or other vascular ischemic disease in the
affected region.
• Who have any significant risk factors or current clinical signs of embolism (e.g.
pulmonary embolus, cerebral infarction, atrial fibrillation, endocarditis, myocardial
infarction, or atheromatous embolic plaque).
• Who have a condition in which increased venous or lymphatic return is not desired
in the affected extremity (e.g., carcinoma).
• Who have decompensated hypertonia in the affected region.
Cryotherapy using the Game Ready GRPro 2.1 System or any cryotherapy
device should not be used in patients:
• Who have significant vascular impairment in the affected region (e.g., from prior
frostbite, diabetes, arteriosclerosis or ischemia).
• Who have known hematological dyscrasias which affect thrombosis (e.g.,
paroxysmal cold hemoglobinuria, cryoglobulinemia, sickle-cell disease, serum cold
agglutinins).
FOR USE WITH
GAME READY MED4 ELITE SYSTEM
ABSOLUTE CONTRAINDICATIONS
Therapy in these situations should
not
be used
in patients.
Cryotherapy (Cold Therapy) using the Med4
Elite or any cryotherapy therapy device
should not be used in patients:
• Who have significant vascular impairment in the
affected region (e.g., from prior frostbite, arteriosclerosis, arterial insufficiency,
diabetes, or other vascular ischemic disease).
• Who have known hematological dyscrasias that predispose to thrombosis (e.g.,
paroxysmal cold hemoglobinuria, cryoglobulinemia, sickle-cell disease, serum cold
agglutinins).
Thermotherapy (Heat Therapy) using the Med4 Elite or any heat
therapy device should not be used in patients:
• Who have current clinical signs in the affected region of significant peripheral
edema (e.g., deep vein thrombosis, chronic venous insufficiency, compartment
syndrome, systemic venous hypertension, heart failure, cirrhosis/liver failure, renal
failure).
• Who have significant vascular impairment in the affected region (e.g., from
prior frostbite, arteriosclerosis, arterial insufficiency, diabetes, or other vascular
ischemic disease).
RELATIVE CONTRAINDICATIONS
Therapy for these conditions should be used in patients only under the
supervision of a licensed healthcare practitioner.
Compression Therapy with the Game Ready GRPro 2.1 System should
be used only under the supervision of a licensed healthcare practitioner
in patients:
• Who have an open wound in the affected region (the wound must be dressed
prior to use of Game Ready).
• Who have an acute, unstable (untreated) fracture in the affected region.
• Who are children under 18 years old or patients who have cognitive disabilities or
communication barriers, whether temporary (due to medication) or permanent.
• Who have a cardiac insufficiency or congestive heart failure (with associated
edema in the extremities or lungs).
• Who have a localized unstable skin condition (e.g., dermatitis, vein ligation,
gangrene, or recent skin graft).
• Who have erysipelas or other active infection in the affected region.
Cryotherapy with the Game Ready GRPro 2.1 System should be used
only under the supervision of a licensed healthcare practitioner in
patients:
• Who have Raynaud’s disease or cold hypersensitivity (cold urticaria).
• Who have hypertension or extreme low blood pressure.
• Who have diabetes.
• Who have compromised local circulation or neurologic impairment (including
paralysis or localized compromise due to multiple surgical procedures) in the
affected region.
• Who have a localized unstable skin condition (e.g., dermatitis, vein ligation,
gangrene, or recent skin graft).
• Who have rheumatoid arthritis in the affected region.
• Who are children under 18 years old or patients who have cognitive disabilities or
communication barriers, whether temporary (due to medication) or permanent.
• Who have tissues inflamed as result of recent injury or exacerbation of chronic
inflammatory condition.
• Who have extremities with diffuse or focal impaired sensitivity to pain or
temperature that prevent the patient from giving accurate and timely feedback.
• Who have cognition or communication impairments that prevent them from giving
accurate and timely feedback.
• Who have an acute, unstable (untreated) fracture in the affected region.
• Who have 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).
• Who have (local) malignancy.
• Who have actively bleeding tissue or hemorrhagic conditions.
• Who have any active local or systemic infection.
• Who have recently radiated tissue or areas affected by heat-sensitive skin
diseases (e.g., eczema, psoriasis, vasculitis, dermatitis).
• Who are pregnant.
SUPERSEDED
