EN-11
Compression Therapy (vasopneumatic compression) using the Game Ready 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 history or current clinical signs suggestive of deep vein thrombosis or
pulmonary embolus in the affected region (to be treated with this therapy).
•
Who have significant arteriosclerosis or other vascular ischemic disease in the affected region.
•
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 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).
C o n t r A i n d i C A t i o n S
Caution: United States Federal law restricts this device to sale by or on the order of
a licensed health care practitioner.
•
Follow the treatment recommendations of your health care practitioner for duration and
frequency of use for this device.
The Game Ready System combines cold and compression therapies. It 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.
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
WArninGS
•
Improper placement or prolonged use of the Game Ready System could result in tissue
damage.
•
During the course of therapy, patients should monitor the skin surrounding the treated
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,
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
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 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.
i n d i C A t i o n S F o r U S e