G e N e R A l W A R N i N G S A N d c A u t i o N S
Improper placement or prolonged use of the Game Ready System could result in tissue
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damage.
During the course of therapy, patients should monitor the skin surrounding the treated
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region or the digits of the extremities of the treated limb for any burning, itching,
increased swelling, or pain. If any of these signs present, or any changes in skin
appearance occur (such as blisters, increased redness, discoloration, or other noticeable
skin changes), patients are advised to discontinue use and consult a physician.
Game Ready Wraps are not sterile; do not place directly against open wounds, sores,
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rashes, infections, or stitches. The Wrap may be applied over clothing or dressing.
Game Ready Wraps are available in multiple configurations but are not intended for
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all possible physiologic uses. For example, the Ankle Wrap is not designed for use on the
toes and the Back Wrap is not designed for use in the abdominal region.
Compression Therapy (vasopneumatic compression) with the Game Ready System
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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
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to use of Game Ready).
Who have an acute, unstable (untreated) fracture in the affected region.
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Who are children under 18 years old or patients who have cognitive disabilities or
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communication barriers, whether temporary (due to medication) or permanent.
Who have a cardiac insufficiency or congestive heart failure (with associated edema
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in the extremities or lungs).
Who have a localized skin condition (e.g., dermatitis, vein ligation, gangrene, skin
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graft) in the affected region.
Who have erysipelas or other active infection in the affected region.
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Cryotherapy with the Game Ready System should be used only under the supervision of
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a licensed healthcare practitioner in patients:
Who have Raynaud's disease or cold hypersensitivity (cold uticaria).
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Who have hypertension or extreme low blood pressure.
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Who have diabetes.
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Who have compromised local circulation or neurologic impairment (including
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paralysis or localized compromise due to multiple surgical procedures) in the
affected region.
Who have rheumatoid arthritis in the affected region.
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Who have a known and uncontrolled peptic ulcer since wraps confining and/or
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cooling the abdomen can cause increased gastrointestinal motility and gastric acid
secretion.
EN-14
WARNiNGS