4 of 6
X
=
Absolute Contraindication
–
Therapy in these situations should
not
be used in patients:
R
=
Relative Contraindication
–
Therapy for these conditions should
be used only under the supervision
of a licensed healthcare practitioner
in patients:
THERAPY
MODE
Cryotherapy
Compression
Who are in the acute stages of inflammatory phlebitis in
the affected region.
X
Who have any current clinical signs suggestive of deep
vein thrombosis in the affected region.
X
Who have significant arteriosclerosis or other vascular
ischemic disease in the affected region.
X
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).
X
Who have a condition in which increased venous or
lymphatic return is not desired in the affected extremity
(e.g., carcinoma).
X
Who have decompensated hypertonia in the affected
region.
X
Who have an open wound in the affected region (the
wound must be dressed prior to use of Game Ready).
R
Who have an acute, unstable (untreated) fracture in the
affected region.
R
Who are children under 18 years old or patients who
have cognitive disabilities or communication barriers,
whether temporary (due to medication) or permanent.
R
R
Who have a cardiac insufficiency or congestive heart
failure (with associated edema in the extremities or
lungs).
R
Who have a localized unstable skin condition (e.g.,
dermatitis, vein ligation, gangrene, or recent skin graft)
in the affected region.
R
R
Who have erysipelas or other active infection in the
affected region.
R
Who have significant vascular impairment in the
affected region (e.g., from prior frostbite, diabetes,
arteriosclerosis or ischemia).
X
Who have known hematological dyscrasias which affect
thrombosis (e.g., paroxysmal cold hemoglobinuria,
cryoglobulinemia, sickle-cell disease, serum cold
agglutinins).
X
Who have Raynaud’s disease or cold hypersensitivity
(cold urticaria).
R
Who have hypertension or extreme low blood pressure.
R
Who have diabetes.
R
Who have compromised local circulation or neurologic
impairment (including paralysis or localized compromise
due to multiple surgical procedures) in the affected
region.
R
Who have rheumatoid arthritis in the affected region.
R
GRPRO 2.1 CONTRAINDICATIONS
GENERAL
IMPORTANT
READ THIS COMPLETE USE GUIDE AND GAME READY GRPRO 2.1 SYSTEM USER
MANUAL AND/OR MED4 ELITE SYSTEM USER MANUAL INCLUDING INDICATIONS,
CONTRAINDICATIONS, CAUTIONS AND WARNINGS BEFORE USING THIS
PRODUCT!
WARNINGS
1. Follow the recommendations of your health care practitioner regarding the
frequency and duration of use.
2. Improper placement or prolonged use of the Game Ready System or Med4 Elite
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.
3. 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. A layer between Wrap and skin is recommended for all patients.
4. 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.
5. To avoid potential damage to the Control Unit, do not use other manufacturers’
Wraps with the Control Unit.
6. Use extra caution during the immediate postoperative period, especially when
sedated or on any medication that could alter normal pain sensation. Check the skin
of the treated region frequently and use mid-to-higher (warmer) temperature range
settings or leave more time between treatments, if necessary.
7. Monitor the level of heat throughout treatment session. Caution should be used
with the Med4 Elite System or any thermotherapy (Heat Therapy) device generating
high intensity heat at 113°F or above. Check the skin of the treated region frequently
and use mid-to-lower (cooler) temperature range settings or leave more time between
treatments, if necessary.
8. The Med4 Elite System is not intended for use with numbing agents.
9. When using heat and rapid contrast therapy, skin should be protected in heat-
sensitive or high-risk patients, especially over regions with sensory deficits.
10. Heating of the gonads should be avoided.
11. Do not cover the toes with the Full Leg Boot.
AVERAGE LIFE EXPECTANCY
The life expectancy of Sleeves and Heat Exchangers will vary widely depending on
frequency of use. Please reference chart below to determine when to replace product.
Sleeve
Light Use (Personal) ......................................................12 months
Medium Use .................................................................6 months
Heavy Use (Clinic or training facility) ............................3 months
Heat Exchanger
Light Use (Personal) ......................................................24 months
Medium Use .................................................................18 months
Heavy Use (Clinic or training facility) ............................12 months
WARRANTY INFORMATION
Sleeve:
In case of manufacturer defect, Sleeve may be returned within 7 days of
purchase.
Heat Exchanger:
1 year from date of purchase. See warranty card included with
Heat Exchanger.