Game ready ATX User Manual

FULL LEG

FOR USE WITH

GAME READY

GRPRO® 2.1 SYSTEM

MED4 ELITE™ SYSTEM

SIZING SPECIFICATIONS

Size

M

(Medium)

L

(Large)

XL

(Extra Large)

Actual Wrap Length

(Adjustment ranges)

30–32” 27–33”

34.5–36.5” 33–37”

39–41” 37”+

Approximate

In-Seam

Anatomical
Orientation

All sizes
t left or
right leg

BEST PRACTICES

• Keep the Control Unit (GRPro 2.1) on a table to prevent drainage
from the Wrap.

• If you are using two Full Leg Boot wraps (one on each leg), we
recommend using the Med4 Elite or two GRPro 2.1 Control Units to
administer therapy. We do not suggest using the dual connector hose
with the GRPro 2.1.

• Never cover the toes when
applying the Full Leg Boot.

PRIMING THE WRAP

To prevent 04 errors at the beginning of therapy with the Full Leg Boot
when used with the GRPro 2.1 Control Unit, it is important to prime
(pre-fill) the Wrap before a therapy.

To prime the Wrap for use with the GRPro 2.1 Control Unit:

1. With the GRPro 2.1 Control Unit off, attach the Connector Hose to
the Control Unit and the Wrap.

2. Lay the Wrap open and flat next to the Control Unit (not on the
body).

3. Turn the System on and run a therapy with no compression. Pause
after 45 seconds.

4. Disconnect the Full Leg Boot from the Control Unit so water
remains in the Wrap. It is now ready for use.

BOOT

USE GUIDE

ENGLISH

WARNING

It is mandatory to fully read and understand your

System’s User Manual before using the device.

Failure to follow operating instructions could result in

serious injury.

IMPORTANT

Read complete indications, contraindications,

cautions, and warning before using this product.

Keep this document for future reference.

NOTE: If you are priming the Full Leg Boot for the first time

using the GRPro 2.1, you may encounter a 04 Error 60 seconds

after pressing play. If this occurs, power off the Control Unit by

pressing the power button. Power it back on, and repeat the

steps listed above.

After completing the previous steps, check the water level in the Control
Unit. If necessary, add more water. Be careful not to overfill the Control
Unit, and allow room for water to return from the Wrap after therapy. Check
the User Manual of your Control Unit for more information on adding water.

If you do not plan to use the Full Leg Boot within the next 24 - 48 hours,
allow the water to drain from the Wrap back into the Control Unit by
leaving it connected to the Control Unit for 2 to 3 minutes. This will
help prevent mildew from forming inside the Wrap and keep your Wrap
performing as expected.

NOTE: It is not necessary to prime the wrap for use with the

Med4 Elite Control Unit.

If water has been in the Wrap for more than one hour, we recommend
pre-cooling/pre-heating the Wrap prior to running a therapy on a patient.

See Pre-Cooling/Pre-Heating Your Wrap for instructions on how to pre-cool/
pre-heat the Full Leg Boot.

PRE-COOLING/PRE-HEATING YOUR WRAP

The Full Leg Boot is designed to deliver therapy over the entire leg and
foot (except the toes). During a therapy, a large amount of water is being
circulated through the Wrap. Pre-cooling/Pre-heating your Wrap will help to
deliver the best therapy possible. From time to time, you may see the actual
temperature deviate from the target temperature. This is normal.

PRE-COOLING YOUR WRAP WITH GRPRO 2.1

1. First, prime your Full Leg Boot. See Priming the Wrap.

2. With water in the Wrap, and
the water level of your Control Unit
at full, run a Cold Therapy with no
compression for 5 minutes.

This will allow the temperature of the
water in the Wrap to equalize with that
of the water in the GRPro 2.1 reservoir.

Run a therapy as desired. Refer to the
User Manual of your Control Unit.

PRE-COOLING YOUR WRAP WITH MED4 ELITE

1. Run a Cold Therapy with no compression for 2 to 3 minutes.

2. Once the actual reservoir temperature is within 2 - 3 °F (1 - 2 °C) of the
target temperature, the Wrap can be applied.

3. Stop the current therapy. Apply the Wrap.

ADJUSTING THE IN-SEAM LENGTH

The Full Leg Boot is designed to accommodate various in-seam lengths.
The Wrap comes ready to use with the standard length. If needed, you
may adjust the length to be either longer or shorter by following the steps
below.

TO LENGTHEN THE WRAP (LONGER IN-SEAM)

1. Detach the hook & loop of the boot section of the Wrap
so that the entire Wrap lays flat on the floor or table

2. Fold the boot section over so that the top edge aligns
with the lower marker (see icon at left). This will add
approximately 1” to the standard in-seam length.

Align top edge of boot
to this line to lengthen
the in-seam length.

Align top edge of boot
to this line to shorten
the in-seam length.

1

3. Secure the boot in place by folding the top piece of
hook & loop toward you as shown.

TO SHORTEN THE WRAP (SHORTER IN-SEAM)

1. Detach the hook & loop of the boot section of the Wrap
so that the entire Wrap lays flat on the floor or table.

2. Fold the boot section over so that the top edge aligns
with the upper marker (see icon at left). This will subtract
approximately 1” from the standard in-seam length.

3. Secure the boot in place by folding the top piece of
hook & loop toward you as shown.

4. Run a therapy as desired. Refer to the User Manual of your Control Unit.

PRE-HEATING YOUR WRAP WITH MED4 ELITE

1. Run a Heat therapy with No Compression for 2 to 3 minutes.

2. Once the actual reservoir temperature is within 2 - 3 °F (1 - 2 °C) of the
target temperature, the Wrap can be applied.

3. Stop the current therapy. Apply the Wrap.

4. Run a therapy as desired. Refer to the User Manual of your Control Unit.

NOTE: Never exceed the upper and lower markers when adjusting

the boot. The top edge should always be between the shortest and

longest in-seam markers.

2

The standard size
is shown in this
example.

Shortest

In-Seam

Standard

Shortest

Longest

3

Fold ap

over to

secure

boot in

place

Longest
In-Seam

2 of 6

FULL LEG BOOT WRAP APPLICATION

Application of the Full Leg Boot should always be performed with the assis­tance of a second person. To prevent injury, never attempt to apply the Wrap
to yourself.

Apply the Wrap with a uniformly close fit, ensuring there are no kinks which
may impede water flow. Ensure the connector hose is placed to prevent the
Wrap from folding or kinking at the hose inlet location of the Wrap.

NOTE: Always have the Wrap applied while either sitting or lying

down with your legs straight.

The Full Leg Boot may be applied to either the left or right leg.

Place the Full Leg Boot flat on the floor or on a

1

therapy table.

The Full Leg Boot ships with the boot section
already formed.

Place the affected

2

foot into the lower

section of the boot with

the heel in the

designated area.

Fold the wrap across the top of the foot and

3

secure on the opposite side of the foot.

NOTE: Never cover the toes when

applying the Full Leg Boot.

Fold the wrap around the ankle and secure on the

4

opposite side of the leg.

Fold the loop side across the top of the leg,

5

ensuring there are no wrinkles in the fabric and

that it’s tight against the leg.

Attach the Wrap to the Control Unit with the Connector Hose. There should be an audible “click”. To

7

disconnect, simply press the blue or gray button and remove the connector from the Wrap.

To remove the Wrap, unhook the leg portion first, then unhook the foot portion. Set the Wrap away

8

from the body.

Fold the hook side across the top of the leg in

6

the other direction, ensuring there are no

wrinkles in the fabric and that the wrap is tight against

the leg.

3 of 6

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 heat­sensitive 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)

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.

......................................................12 months

GRPRO 2.1 CONTRAINDICATIONS

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:

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.

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)
in the affected region.

Who have erysipelas or other active infection in the
affected region.

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).

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 rheumatoid arthritis in the affected region.

THERAPY

MODE

Compression

Cryotherapy

X

X

X

X

X

X

R

R

R R

R

R R

R

X

X

R

R

R

R

R

4 of 6

MED4 ELITE CONTRAINDICATIONS

X = Absolute Contraindication –

Therapy in these situations should not be used in patients who have:

R = Relative Contraindication –

Therapy for these conditions should be used only under the supervision of a
licensed healthcare practitioner in patients who have:

THERAPY MODE

Thermotherapy

Cryotherapy

Rapid Contrast

Compression

Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency,
acute compartment syndrome, systemic venous hypertension, congestive heart failure, cirrhosis/liver failure, renal failure).

Significant vascular impairment in the affected region (e.g., from prior frostbite, arteriosclerosis, arterial insufficiency, diabetes,
vascular dysregulation, or other vascular ischemic disease).

Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sickle-cell
disease, serum cold agglutinins).

Tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition.

Extremities with diffuse or focal impaired sensitivity to pain or temperature that prevent the patient from giving accurate and timely
feedback.

Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical
procedures) in the affected region.

Cognition or communication impairments that prevent them from giving accurate and timely feedback.

An acute, unstable (untreated) fracture in the affected region.

Local malignancy.

Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound,
scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Med4 Elite.

Actively bleeding tissue or hemorrhagic conditions.

Recently radiated tissues or areas affected by heat-sensitive skin diseases (e.g., eczema, psoriasis, vasculitis, dermatitis).

X X X X

X X X X

X R X

X R X

X R X

R R R R

X R X

X R X

X R X

X R R X

X X

X X

Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.

Any active local or systemic infection.

Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis.

A pregnancy.

Any significant risk factors or current clinical signs of embolism (e.g. pulmonary embolus, pulmonary edema, cerebral infraction, atrial
fibrillation, endocarditis, myocardial infarction, or artheromatous embolic plaque).

A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast
cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity).

Raynaud’s disease or cold hypersensitivity (cold urticaria).

Hypertension, Cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.

Children under 18 years old

Had recent toe surgery in the affected region.

Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis.

Decompensated hypertonia in the affected region.

R R R R

X X X

R X X X

X X

X X X

X X X

X X

R R X R

R R R R

R R R

R R X R

X X

5 of 6

ASSEMBLY

The Heat Exchanger (PNs 520921-03, 520922-03, 520923-03) fits inside the Sleeve

(PNs 510921, 510922, 510923) and comes as part of a pre-assembled Wrap (PNs

590921-03, 590922-03, 590923-03)

. If the Heat Exchanger is removed to launder
the Sleeve, or for any other reason, please use the following instructions to
re-insert the Heat Exchanger into the Sleeve.

Place the Sleeve on a

1

flat surface with logo
side up, and determine the
opening location.

Sleeve

Heat

Exchanger

Insert the Heat Exchanger into the

2

Sleeve with the blue side down (The
blue side of the Heat Exchanger should
touch the blue side of the Sleeve).

Be sure the Heat Exchanger is flat

3

inside the Sleeve with no folds or
creases. Zip up the Sleeve, if applicable.
After assembly, lay the blue side up and
ensure the Heat Exchanger is uniformly
laid out and smooth inside the Sleeve.

REMOVAL OF HEAT EXCHANGER

1. Disconnect the Connector Hose from the Wrap

2. Unzip the zipper

3. Gently remove the Heat Exchanger

CARE AND CLEANING

DAILY

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, or as needed, use Sterifab
according to manufacturer’s instructions to minimize microbe transfer.

EXTENDED CARE

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.

on the blue side of sleeve

STORAGE

Hang your Wrap on a wide hanger or lay flat. Do not fold or stack it, as this could kink
the fluid chamber and the Wrap will not work properly.

COOLSYSTEMS®, INC.
DBA Game Ready
1800 Sutter Street, Suite 500
Concord, CA 94520 USA

EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands

1.888.GAMEREADY +1.510.868.2100
www.gameready.com

© 2018 CoolSystems, Inc. All Rights Reserved

Game Ready Dual Action Wrap Use Guide

Full Leg Boot Wrap PN 705283 Rev B

CONTACT US

In the U.S. call Game Ready Customer Service at 1.888.426.3732 (+1.510.868.2100).
From outside of the U.S. please refer to www.gameready.com to find your local
distributor’s contact information.

A list of current patent(s) covering Game Ready technology can be found at:

www.gameready.com/patents.

Symbol for “assembled in” a specific country (XXXX).

Symbol for “made in” a specific country (XXXX).

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.

Wrap (PNs 590921-03, 590922-03, 590923-03) includes Sleeve (PNs 510921, 510922, 510923) &
Heat Exchanger (PNs 520921-03, 520922-03, 520923-03)

The Full Leg Boot Use Guide may be updated from time to time. The most current
version of the Use Guide can be found online in various languages at
www.gameready.com.

If you require a paper copy of this manual, contact Game Ready Customer Service at

1.888.426.3732. International customers contact your local distributor.

دليل المستخدم هذا متوفر بلغات عدة على الموقع الإلكتروني

Dieses Betriebshandbuch ist in verschiedenen Sprachen online unter

Este Manual del usuario está disponible en www.gameready.com en distintos idiomas

可前往在线获得本用户手册的多种语言版本

Denne brugervejledning kan 󰘰ndes online på forskellige sprog på

Deze Gebruikershandleiding is online beschikbaar in verschillende talen op

Tämä käyttöopas löytyy netistä eri kielillä: www.gameready.com

On peut trouver ce manuel de l’utilisateur dans plusieurs langues en ligne à

Μπορείτε να βρείτε αυτό το Εγχειρίδιο Χρήσης σε ηλεκτρονική μορφή σε διάφορες

www.gameready.com ניתן למצוא את המדריך הזה למשתמש בשפות שונות באתר

에 가시면 이 사용자 설명서를 온라인에서 다양한 언어로 찾아보실 수 있습니다.

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Este Manual do Usuário pode ser encontrado online em vários idiomas em

Данную инструкцию по применению, а также ее переводы на различные языки,

Denna användarhandbok 󰘰nns tillgänglig på olika språk på nätet via

Bu Kullanıcı Kılavuzu, değişik dillerde çevrimiçi olarak www.gameready.com

®

γλώσσες στη διεύθυνση: www.gameready.com

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へ行けば様々な言語でオンライン閲覧できます。

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