Game ready ATX User manual

FULL LEG
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.
FOR USE WITH
GAME READY
GRPRO®2.1 SYSTEM
MED4 ELITE™ SYSTEM
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.
SIZING SPECIFICATIONS
Size Actual Wrap Length
(Adjustment ranges)
Approximate
In-Seam
Anatomical
Orientation
M
(Medium) 30–32” 27–33”
All sizes
t left or
right leg
L
(Large) 34.5–36.5” 33–37”
XL
(Extra Large) 39–41” 37”+
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.

2 of 6
2
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.
ADJUSTINGTHE 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.
3. Secure the boot in place by folding the top piece of
hook & loop toward you as shown.
TO SHORTENTHE 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.
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.
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.
4. Run a therapy as desired. Refer to the User Manual of your Control Unit.
PRE-HEATINGYOUR 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.
Longest
In-Seam
Shortest
In-Seam
3
1
Shortest
Standard
Longest
The standard size
is shown in this
example.
Fold ap
over to
secure
boot in
place

3 of 6
FULL LEG BOOT WRAP APPLICATION
1Place the Full Leg Boot flat on the floor or on a
therapy table.
The Full Leg Boot ships with the boot section
already formed.
2Place the affected
foot into the lower
section of the boot with
the heel in the
designated area.
Application of the Full Leg Boot should always be performed with the assis-
tance 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.
4Fold the wrap around the ankle and secure on the
opposite side of the leg.
3Fold the wrap across the top of the foot and
secure on the opposite side of the foot.
NOTE: Never cover the toes when
applying the Full Leg Boot.
5Fold the loop side across the top of the leg,
ensuring there are no wrinkles in the fabric and
that it’s tight against the leg.
6Fold the hook side across the top of the leg in
the other direction, ensuring there are no
wrinkles in the fabric and that the wrap is tight against
the leg.
7Attach the Wrap to the Control Unit with the Connector Hose. There should be an audible “click”. To
disconnect, simply press the blue or gray button and remove the connector from the Wrap.
8To remove the Wrap, unhook the leg portion first, then unhook the foot portion. Set the Wrap away
from the body.
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.

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.

5 of 6
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
Compression
Rapid Contrast
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). XXXX
Significant vascular impairment in the affected region (e.g., from prior frostbite, arteriosclerosis, arterial insufficiency, diabetes,
vascular dysregulation, or other vascular ischemic disease). XXXX
Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sickle-cell
disease, serum cold agglutinins). XRX
Tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition. X R X
Extremities with diffuse or focal impaired sensitivity to pain or temperature that prevent the patient from giving accurate and timely
feedback. X R X
Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical
procedures) in the affected region. RRRR
Cognition or communication impairments that prevent them from giving accurate and timely feedback. X R X
An acute, unstable (untreated) fracture in the affected region. X R X
Local malignancy. X R X
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. X R R X
Actively bleeding tissue or hemorrhagic conditions. X X
Recently radiated tissues or areas affected by heat-sensitive skin diseases (e.g., eczema, psoriasis, vasculitis, dermatitis). X X
Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region. RRRR
Any active local or systemic infection. X X X
Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis. R X X X
A pregnancy. X X
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). XXX
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). XXX
Raynaud’s disease or cold hypersensitivity (cold urticaria). X X
Hypertension, Cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency. R R X R
Children under 18 years old RRRR
Had recent toe surgery in the affected region. RRR
Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis. R R X R
Decompensated hypertonia in the affected region. X X
MED4 ELITE CONTRAINDICATIONS

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®on the blue side of sleeve
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.
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.
© 2018 CoolSystems, Inc. All Rights Reserved
Game Ready Dual Action Wrap Use Guide
Full Leg Boot Wrap PN 705283 Rev B
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
EMERGO AUSTRALIA
201 Sussex Street
Darling Park, Tower II, Level 20
Sydney NSW 2000
Australia
COOLSYSTEMS®, INC.
DBA Game Ready®
1800 Sutter Street, Suite 500
Concord, CA 94520 USA
1.888.GAMEREADY +1.510.868.2100
www.gameready.com
REMOVAL OF HEAT EXCHANGER
1. Disconnect the Connector Hose from the Wrap
2. Unzip the zipper
3. Gently remove the Heat Exchanger
1Place the Sleeve on a
flat surface with logo
side up, and determine the
opening location.
2Insert the Heat Exchanger into the
Sleeve with the blue side down (The
blue side of the Heat Exchanger should
touch the blue side of the Sleeve).
3Be sure the Heat Exchanger is flat
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.
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.
Sleeve
Heat
Exchanger
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.
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Dieses Betriebshandbuch ist in verschiedenen Sprachen online unter
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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
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On peut trouver ce manuel de l’utilisateur dans plusieurs langues en ligne à
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Μπορείτε να βρείτε αυτό το Εγχειρίδιο Χρήσης σε ηλεκτρονική μορφή σε διάφορες
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Questo Manuale per l’utente è disponibile online in varie lingue su
www.gameready.com
本ユーザー・マニュアルは、www.gameready.com
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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에 가시면 이 사용자 설명서를 온라인에서 다양한 언어로 찾아보실 수 있습니다.
Niniejszą Instrukcję obsługi można znaleźć w internecie w różnych językach na stronie
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Este Manual do Usuário pode ser encontrado online em vários idiomas em
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Данную инструкцию по применению, а также ее переводы на различные языки,
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Denna användarhandbok 󰘰nns tillgänglig på olika språk på nätet via
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