Game Ready 500055 User Manual - page 5
C O N T R A I N D I C A T I O N S
• Compression Therapy (vasopneumatic compression) using Game Ready 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 risk factors for deep vein thrombosis or pulmonary embolus
(including prolonged bed rest) in the affected region (to be treated with this therapy)
- Who have a cardiac insufficiency or congestive heart failure (with associated edema in the
extremities or lungs)
- Who have significant arteriosclerosis or other vascular ischemic disease in the affected
region
- Who have a localized skin condition (eg, dermatitis, vein ligation, gangrene, skin graft) in
the affected region
- Who have a condition in which increased venous or lymphatic return is not desired in the
affected extremity (eg, carcinoma)
- Who have erysipelas or other active infection in the affected region
- Who have decompensated hypertonia in the affected region
• Cryotherapy using Game Ready or any cryotherapy device should
not
be used in patients:
- Who have significant vascular impairment in the affected region (eg, from prior frostbite,
diabetes, arteriosclerosis or ischemia)
- Who have acute paroxysmal cold hemoglobinuria or cryoglobulinemia
G E N E R A L W A R N I N G S A N D P R E C A U T I O N S
Thank you for choosing the Game Ready System. To assure you have the best experience
possible, please be sure to read the entire User’s Manual prior to use of the product.
Caution: Federal Law restricts this device to sale by or on the order of a licensed health
care practitioner.
WARNINGS
•
Improper placement or prolonged use of Game Ready could result in tissue damage such
as frostbite.
• During the course of Game Ready 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.
• The Game Ready Wrap is not sterile; do not place directly against open wounds, sores,
rashes, infections, or stitches. May be applied over clothing or dressing.
• 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 a 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
• Cryotherapy with the Game Ready System should be used
only under the supervision
of a
licensed healthcare practitioner in patients:
- Who have Raynaud’s disease or cold hypersensitivity (cold uticaria)
- 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 are children or who have cognitive disabilities or communication barriers
- Who have rheumatoid arthritis in the affected region
- Who have known and un-controlled peptic ulcer (if the affected region is the abdominal
region) since cold therapy applied to the abdomen can cause increased gastrointestinal
motility and gastric acid secretion
4