Game ready ATX COOLING VEST, Use Manual

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FOR USE WITH
GAME READY GRPRO 2.1 SYSTEM
ABSOLUTE CONTRAINDICATIONS
Compression Therapy using the Game Ready
GRPro 2.1 System or any compression thera-
py 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 cryother-
apy 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).
RELATIVE CONTRAINDICATIONS
Compression Therapy with the Game Ready GRPro 2.1 System should
be used only under the supervision of a licensed healthcare practi-
tioner 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.
IMPORTANT
Do not set the Game Ready System to high pressure or medium
pressure when using the Cooling Vest.
READ THIS COMPLETE USER
MANUAL AND GAME READY SYSTEM USER MANUAL INCLUDING
INDICATIONS, CONTRAINDICATIONS, CAUTIONS AND WARNINGS
BEFORE USING THIS PRODUCT!
WARNINGS
• Follow the recommendations of your health care practitioner regarding
the frequency and duration of use.
• 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.
NOTES
Apply wrap with a uniformly close and tight fit, ensuring there are no kinks
which may impede air or water flow.
CARE AND CLEANING
For daily care and to minimize formation of mildew, remove heat exchanger
from sleeve and wipe with dry towel to remove any condensation that may
form. Turn sleeve inside out and hang both the sleeve and heat exchanger
to release excess moisture. For multi-patient use, if needed, use Sterifab®
according to manufacturer’s instructions to minimize microbe transfer.
For extended care, carefully remove the heat exchanger from the sleeve
and turn the sleeve inside out. Hand or machine wash the sleeve in cold
water and mild detergent, or antibacterial soap. Hang to dry. Hand wash
the heat exchanger with warm water and mild detergent, do not machine
wash or place in a dryer. Hang to dry.
Warning: To comply with California Proposition 65, the following
warning has been included: This product contains chemicals
known to the State of California to cause cancer, birth defects or
other reproductive harm.
SUPERSEDED