Game ready ATX HAND, Use Manual

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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).
• 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 (local) malignancy.
• 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 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.
Rapid Contrast Therapy with the Med4 Elite should not be used in
patients:
• All Cryotherapy and Thermotherapy Absolute contraindications apply to Rapid
Contrast Therapy.
Compression Therapy using the Med4 Elite or any compression therapy
device should not be used in patients:
• Who have current clinical signs in the affected region of peripheral edema (e.g.,
deep vein thrombosis, chronic venous insufficiency, compartment syndrome,
systemic venous hypertension, heart failure, cirrhosis/liver failure, renal failure)
• Who have current clinical signs of inflammatory phlebitis, venous ulcers, localized
wound infection or cellulitis
• 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 any significant risk factors or current clinical signs of embolism (e.g.
pulmonary embolus, cerebral infraction, atrial fibrillation, endocarditis, myocardial
infarction, or artheromatous embolic plaque).
• Who have 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).
RELATIVE CONTRAINDICATIONS
Therapy for these conditions should be used in patients only under the
supervision of a licensed healthcare practitioner.
Cryotherapy (Cold Therapy) with the Med4 Elite 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 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) 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 any active inflammatory condition in the affected region.
• Who have had recent toe surgery in the affected region.
Thermotherapy (Heat Therapy) with the Med4 Elite should be used
only under the supervision of a licensed healthcare practitioner in
patients:
• Who are obtunded or with diabetes mellitus, multiple sclerosis, poor circulation,
spinal cord injuries, and rheumatoid arthritis.
• Who have any active skin infection.
• Who have cardiac failure and/or hypertension.
• Who are children under 18 years old or patients who have cognitive disabilities or
communication barriers, whether temporary (due to medication) or permanent.
Rapid Contrast Therapy with the Med4 Elite should be used only under
the supervision of a licensed healthcare practitioner in patients:
• All Cryotherapy and Thermotherapy Relative Contraindications also apply to Rapid
Contrast Therapy.
Compression Therapy with the Med4 Elite 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 Med4 Elite).
• 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 localized unstable skin condition (e.g., dermatitis, vein ligation,
gangrene, or recent skin graft) in the affected region.
• Who have any active infection in the affected region.
• Who have had recent toe surgery in the affected region.
SUPERSEDED