GRPRO 2.1 Models 550550-xx Control Unit Users Manual Rev-N

Page 1

G R Pro 2.1 C O N T R O L U N I T

User’s Manual

MODEL NUMBERS

550550-03, 550550-03-RN, 550550-53

Page 2

This User’s Manual can be found online in various languages at

www.gameready.com

‫دليل المستخدم هذا متوفر بلغات عدة على الموقع اإللكتروني‬

www.gameready.com

Dieses Betriebshandbuch ist in verschiedenen Sprachen online unter

www.gameready.com verfügbar

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

www.gameready.com

Denne brugervejledning kan findes online på forskellige sprog på www.gameready.com

Deze Gebruikershandleiding is online beschikbaar in verschillende talen op

www.gameready.com

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

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

www.gameready.com

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

στη διεύθυνση: www.gameready.com

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

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。

www.gameready.com

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

Niniejszą Instrukcję obsługi można znaleźć w internecie w różnych językach na stronie

www.gameready.com

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

www.gameready.com

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

можно найти на веб-сайте www.gameready.com

Denna användarhandbok finns tillgänglig på olika språk på nätet via

www.gameready.com

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

adresinde bulunmaktadır

Page 4

INTRODUCTION TO GAME READY

Based in Concord, California, and founded in 1997, Game Ready® (CoolSystems, Inc.) is a

best-in-class sports medicine and orthopedic medical device that helps athletes and patients

recover from injury or orthopedic surgery.

The Game Ready System with ACCEL® Technology gives healthcare providers the power

to accelerate the body’s natural repair mechanisms, setting a new standard in injury and

post-op recovery.

Comprised of a control unit featuring proprietary ACCEL Technology (Active Compression

and Cold Exchange Loop) and a complete range of dual-action Wraps designed for each

body part, the revolutionary system uniquely integrates active compression and cold

therapies to accelerate natural healing.

Immediately after suffering a musculoskeletal injury, the body initiates a series of

physiological responses to defend surrounding tissues and begins to repair the damage. While

inflammation is a natural and necessary mechanism in this process, controlling it effectively

can actually allow the body to enter the later stages of healing faster. Until now, the RICE

(Rest-Ice-Compression-Elevation) principles have been used to passively control symptoms,

moderating pain and swelling. Going beyond static cold and compression applications,

Game Ready with ACCEL Technology proactively aids lymphatic function, encourages

cellular oxygen supply, and stimulates tissue repair.

REGISTER YOUR PRODUCT

Please complete your Warranty Registration within 30 days for both the GRPro® 2.1

Control Unit and the Wraps online at www.gameready.com. A Wrap registration card is

packaged with each Wrap. Further warranty information can be found in the Warranty

Section of this manual.

DON’T JUST TREAT SYMPTOMS, HELP ACCELERATE HEALING

We’d enjoy hearing from you. If you have questions, want to learn more, or wish to share

your experience with the Game Ready System, please call us at 1.888.426.3732, or email

us at info @ gameready.com.

1.888.GameReady (1.888.426.3732)

www.gameready.com

CAUTION: United States Federal law restricts this device to sale by or on the order of

a licensed healthcare practitioner.

WARNING: Follow the recommendations of your health care practitioner regarding the

frequency and duration of use. Improper placement or prolonged use of the GRPro 2.1

could result in tissue damage. Discontinue use immediately if you experience burning,

itching or increased pain and swelling. Monitor the skin receiving cold therapy

frequently and discontinue use if changes such as blisters, increased redness,

discoloration or welts occur.

IMPORTANT: READ COMPLETE INDICATIONS, CONTRAINDICATIONS,

CAUTIONS AND WARNINGS BEFORE USING THIS PRODUCT!

EN- 2

Page 5

DESCRIPTION OF THE GRPRO® 2.1 SYSTEM

The following items are included in your GRPro 2.1 System:

Power Cord

sure

Pres

Off

Low

Med

High

AC Adapter

User’s Manual

p

Wra

Avg. p.

Tem

55/13

50/10

45/7

40/5

ºF/ºC

p

Slee

Time

Run

Time

Bath

Ice p.

Tem

Connector

 ose

H

GRPro 2.1

Control Unit

with ACCEL®

Technology

®

Series

Heat Exchanger

A Wrap (comprised of an inner

ATX Series Heat Exchanger and

an outer Sleeve) must be attached

to the system to begin treatment.

Each Wrap is sold separately and

is not included in the system.

Wrap

(sold separately)

Sleeve

Volume

Power

Indicator

Pressure

Backlight

Pressure

Indicator

Actual

Temperature

Pressure

Off

Low

Med

High

Actual

Temperature

55/13

Power

50/10

Program

40/5

45/7

ºF/ºC

Play/

Pause

Sleep

Time

Run

Time

Temperature

Knob

Target

Temperature

C/F(Celsius/Fahrenheit)

Target

Temperature

Subtract Add

Time

Time

(Manual Mode)

Note: For assistance setting up, using or maintaining the system, or to report

unexpected operation or events, please contact Customer Service at 1.888.426.3732

(+1.510.868.2100), from outside of the U.S. please contact your local distributor.

EN-3

Page 6

Game Ready System as to electrical shock, fire and mechanical

hazards only in accordance with EN 60601-1:2006 + A1:2013, IEC

60601-1:2012, IEC 60601-1-6:2010(3rd Ed.) + A1:2013, IEC 60601-111:2010 and ANSI/AAMI ES60601-1:2005(R)2012.

Powered by Direct Current

Type BF Applied Parts

Warning: It is mandatory to fully read and understand the

Instructions for Use before using the device. Failure to follow

operating instructions could result in serious injury.

Attention: Consult Instructions for Use

Manufacturer

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

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

DETAILED INSTRUCTIONS FOR USE

Users are required to read this User’s Manual in full prior to using this device.

Do not use this device without your physician’s specific recommendations for the frequency

and duration of your treatments.

The most common recommendation is to use cold therapy at least 4 times a day, for approximately

30 minutes each time, with at least a 30-minute break between treatments.

While the temperature is adjustable, it is reported that the greatest benefit from cold therapy

is in the 40-60°F (4.5-15.5°C) temperature range.

Generally reported compression recommendations are for “None” to “Low” pressure

settings during the first 24-48 hours after surgery or injury, increasing to “Medium” or

“High” only if it is comfortable after the first 48 hours.

We recommend that “High” pressure is never applied if you are confined to bed.

EN- 4

Page 7

MODES OF OPERATION

Manual Mode: The system automatically starts in this mode, and allows the user to adjust

treatment time and pressure settings.

Program Mode: This mode allows the user to choose one of six treatment programs that

provide therapy for a set time then sleep (no treatment) for a set time, continuously, at a

specific pressure setting.

Drain Mode: Allows a user to connect a Hose with a special Hose Adapter (purchased

separately) to the unit, enter Drain Mode and have the unit empty the water out of the ice

box through the Hose. Drain Mode can be accessed by pressing the program key and

toggling through all six programs. To empty water in the system while in Drain Mode, press

the program key until you reach Drain Mode, attach the Hose Adapter to the Connector Hose,

place the Hose Adapter over a sink, and press the Play button. Drain Mode will run the

Control Unit’s fluid pump for up to six minutes (long enough to fully empty the ice box).

Drain Mode is indicated by the following icons:

BUTTONS

Power: Use this button to turn the Control Unit on and off.

Program: Use this button to select one of the available Programs or to return to

Manual Mode. See page 11 in this manual for more information on Programs.

Play/Pause: Use this button to start or pause a treatment.

Add Time: Use this button to add time in Manual Mode (does not work in Program

Mode). You can add up to 90 minutes. Treatment must be paused in order to add

or subtract time.

Subtract Time: Use this button to reduce time in Manual Mode (does not work in

Program Mode). You can subtract up to 90 minutes. Treatment must be paused in

order to add or subtract time.

Pressure Selection: Use this button to select one of four pressure settings: No

Pressure, Low Pressure (5-15 mmHg), Medium Pressure (5-50 mmHg), and High

Pressure (5-75 mmHg). Pressure selection is not available in Program Mode.

Treatment must be paused to change pressure settings.

Volume: Use this button to select the option of sound or no sound. Push to mute

sound. Alarms will still sound even with Volume off.

C/F Button: Use this button to select either Celsius or Fahrenheit on the

temperature display.

Backlight: Use this button to turn the backlight on or off.

EN-5

Page 8

ADJUSTING TEMPERATURE

To adjust the temperature being applied during treatment, simply turn the temperature

knob towards 3 snowflakes for the maximum amount of cold, or towards 1 snowflake for

the least amount of cold. Notice that as you adjust the knob, the “Target Temperature” on

the display will change. The system will automatically adjust to match the temperature you

have selected.

TIP: The maximum amount of cold is dictated by the amount of ice in the reservoir and

the setting of the temperature adjustment knob. You may need to stir or replenish the ice

to achieve coldest temperatures. Ice will melt faster in the acute phases of injury as the

Game Ready System is removing greater amounts of heat from the treatment site.

DISPLAY

Status bar:

Off (Mute)

On

Indicates selected mode.

Indicates unit is paused.

Indicates unit is running.

Other Icons:

Error

Sleep

Battery

Temperature:

Indicates an error. See troubleshooting

pages 24-26 for error codes.

Indicates sleep mode time.

Indicates remaining battery capacity.

Actual Temperature: Approximate

temperature of the water leaving the

Control Unit.

Target Temperature: Indicates the

target temperature setting. The Control

Unit will automatically match the Actual

Temperature and Target Temperature as

closely as possible.

EN- 6

Page 9

Displays the amount of run time

remaining.

Sleep time

count-down bars.

Run time count-down bars.

When the system

is running in

Program Mode:

Displays the amount of sleep time

remaining.

When the system

is running in

Manual Mode:

Displays the amount of run time

remaining.

When selecting a

program:

Displays pressure.

Pressure

Off

Low

Med

High

Actual

Temperature

55/13

50/10

45/7

40/5

ºF/ºC

Sleep

Time

Displays amount of

time unit will sleep.

Pressure:

Off

Low

Med

High

Off

Low

Med

High

Off

Low

Med

High

Off

Low

Med

High

Run

Time

Target

Temperature

Displays amount of

time unit will run.

EN-7

Page 10

OPERATING THE SYSTEM

To operate your GRPro 2.1 System, you need:

• Control Unit filled with ice and water as indicated by the fill line labels within the

reservoir. Optimal performance is achieved by first adding 1.5 liters of water, and then

filling the reservoir to the top with ice.

• Game Ready supplied power supply.

• Connector Hose.

• Wrap (includes a Heat Exchanger and Sleeve).

Notes:

• The Wrap is comprised of an inner Heat Exchanger and an outer Sleeve. The combination

of Sleeve and Heat Exchanger is referred to throughout this manual as a “Wrap.” To ensure

proper performance, be sure to use ATX Series Heat Exchangers.

• The Control Unit should be placed on a stable surface (such as the floor or a table) during

use.

• Note that using the system in an environment with a high ambient temperature may

affect its ability to provide adequate cooling, or may limit the ice life.

• If you will be using the system with a Game Ready optional battery pack (sold separately),

please consult the instructions for use that accompany that battery pack.

Warning:

• Your GRPro 2.1 Control Unit should be plugged into a grounded electrical outlet

prior to operation when using the FSP Power Supply. When using the Mega MDM030-A120-5396 power supply, a grounded electrical outlet is not required.

• Position the Control Unit to minimize the risk of tripping over the Control Unit, Connector

Hose, or power cord.

Precautions:

• Failure to properly follow the instructions of this manual and those of your medical

provider may interfere with or prevent delivery of appropriate therapy.

• To avoid risk of electrical shock unplug the Control Unit from the electrical outlet prior to

filling the Control Unit with ice and water.

1

EN- 8

Push the door release button to open the ice box door.

Page 11

2

Add water to fill-line indicated on label within the reservoir. DO NOT OVERFILL. Add

ice to top of reservoir.

3

Close the ice box door. Make sure you hear it click.

Click

4

Place the Control Unit in the location where you plan to use it. The Control Unit should

only be used in the upright orientation as shown. The Control Unit will leak if placed on

its side.

5

Connect the AC Adapter to the receptacle on the end panel of the Control Unit, then

plug the AC Adapter into an electrical outlet. The power indicator light (orange color)

on the Control Unit should illuminate. Press the power button.

The screen should

light up and the Control Unit should beep twice. The power indicator light should turn

from orange to green. If you

do not see these indicators,

refer to “Control Unit will not

turn on” on page 26 of the

Troubleshooting Guide in this

manual.

AC Adapter

Note: The Control Unit should

be turned on prior to attaching

a Wrap.

to electrical outlet

EN-9

Page 12

6

Connect the larger end of the

Connector Hose (with the red

button) to the Control Unit.

Make sure you hear it click.

To disconnect, simply press

the red button and remove

the connector from the

Control Unit.

Disconnect

Button

Connector Hose

7

to Wrap

Apply the selected Wrap (consult the Use Guide accompanying each Wrap for

application instructions). To ensure proper performance of the system, it is important

to use ATX Series Heat Exchangers in your Wrap.

Caution:

• The Wrap is not sterile. Do not place directly against open wounds, sores,

rashes, infections, or stitches. The Wrap may be applied over clothing or

dressing.

• To ensure best fit, be sure the Wrap is completely deflated prior to each

application.

8

Connect the smaller end of the Connector Hose (with a blue or gray button) to the

Wrap. Make sure you hear it click. To disconnect, simply press the blue or gray button

and remove the connector from the Wrap.

Click

Disconnect Button

If you have any problems with the set-up of your GRPro 2.1 System, 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 contact your local distributor.

Warnings:

• Follow the treatment recommendations of your health care practitioner

for the use of this device.

• Improper placement or prolonged use of the GRPro 2.1 could result in tissue

damage.

• READ COMPLETE INDICATIONS, CONTRAINDICATIONS, CAUTIONS AND

WARNINGS BEFORE USING THIS PRODUCT!

EN- 10

Page 13

9

Select the operating mode. You can choose either Manual Mode or

Program Mode. Manual Mode allows you to customize the time and

pressure settings. Program Mode allows you to select one of six

automated programs that provide treatment for a set time interval then “sleep” (providing

no treatment) for a set time, continuously, at a specific pressure setting (refer to list of

available programs below). The unit automatically starts in Manual Mode.

Manual Mode:

Set the time in five minute increments by pushing the +/- buttons.

Set the pressure by pushing the pressure button. You can select

from 4 pressure settings: No pressure, Low Pressure (5-15mmHg),

(Medium Pressure (5-50mmHg), High Pressure (5-75mmHg).

Program Mode:

Push the program button to enter Program Mode. In Program Mode,

the unit will operate continuously according to the selected program.

You will need to replenish ice and water as previously indicated in

step 2.

You can select from the following programs: (Push the Program

Button to scroll through the available programs.)

Program 1: 30 minutes on, 30 minutes sleep. No pressure.

Program 2: 30 minutes on, 30 minutes sleep. Low pressure.

Program 3: 30 minutes on, 30 minutes sleep. Medium pressure.

Program 4: 30 minutes on, 60 minutes sleep. No pressure.

Program 5: 30 minutes on, 60 minutes sleep. Low pressure.

Program 6: 30 minutes on, 60 minutes sleep. Medium pressure.

Program d: Drain Mode. Please refer to page 5 in this manual for

details.

10

11

Press play/pause button to start your Game Ready treatment with ACCEL

Technology. Press play/pause at any time to stop your treatment.

Set to your target temperature (displayed in the

Target Temperature window) by turning the knob.

For coldest therapy, turn the knob clockwise towards

three snowflakes. For warmer therapy, turn the knob

counter-clockwise towards one snowflake.

More

Cold

Less

Cold

12

Replenish ice and water levels as necessary, and indicated in Step 2, to maintain your

target temperature.

13

After use:

•

•

•

•

Unplug the AC Adapter and the Connector Hose from the Control Unit

Push the door release button to open the door

Carefully pour out the ice and water

Wipe off any excess water

EN-11

Page 14

STORAGE

When you are done using the system for the day:

• Unplug the AC Adapter and the Connector Hose from the Control Unit.

• Push the door release button to open the door.

• Carefully pour out the ice and water.

• Wipe off any excess water.

• Store the Control Unit with the lid fully open to allow the interior to dry and preserve

the reservoir seal. Store the Control Unit in the Carry Bag or in another safe location.

Remember that your GRPro 2.1 Control Unit is a valuable piece of equipment and should

be treated with great care, like a laptop computer.

System Storage Temperature: 33° - 120°F (1° - 50°C)

Relative Humidity: 10% - 95% non-condensing

Caution: Do not keep in extreme cold or hot temperatures (below 33°F or above 120°F

or below 1° or above 50°C). Do not leave in a hot or freezing car. Do not leave the Control

Unit in direct sunlight. The UV light may damage or discolor the Control Unit.

CLEANING

SYSTEM

If desired, the system (Control Unit, Hoses, and Wraps) can be flushed with a mixture of

isopropyl alcohol and water, and run on no compression (“off”). This should be followed by

running the Control Unit with clean water only on the no compression (“off”) setting.

CONTROL UNIT

The exterior of the Control Unit and the visible interior surfaces of the reservoir can be

cleaned with a soft cloth and one of the following cleaning agents:

•

•

•

•

•

•

Mild detergent

70% Isopropyl alcohol

Antifect® FF

Mikrozid® Sensitive Wipes

Quaternary ammonium (such as Virex® – typically only found in a clinical use setting)

Cavicide®

Procedure:

• Follow the manufacturer’s instructions and precautions for the cleaning agent you select.

• Apply the selected cleaner to a soft cloth and wipe down all surfaces of the Control Unit.

• Allow the Control Unit to dry thoroughly before storing it in the bag.

• The Control Unit should be cleaned as needed.

DO NOT USE:

• Phenolic-based disinfectants (such as Amphyl® – typically only found in a clinical use

setting).

• Any solvent-based cleaners on the Control Unit. Doing so will damage the plastics and

will void your warranty.

• Abrasive materials to clean the Control Unit. Doing so will damage the plastics and will

void your warranty.

Caution: The Control Unit is not a waterproof device. Do not apply a direct stream of any

liquid onto the Control Unit, submerge the Control Unit, or allow any liquid to pool on the

surface of the front panel of the Control Unit.

EN- 12

Page 15

CONNECTOR HOSE

The surface of the Connector Hose can be cleaned using a soft cloth and one of the

following:

• Mild detergent

• Steri-Fab®

• Antifect® FF

• Mikrozid® Sensitive Wipes

• 70% Isopropyl alcohol

• We do not recommend the use of quaternary ammonium (such as Virex®) or Cavicide.®

DO NOT USE:

• Phenolic-based disinfectants (such as Amphyl® – typically only found in a clinical use

setting).

• Any solvent based cleaners. Doing so will damage the plastics and will void your

warranty.

• Abrasive materials. Doing so will damage the plastics and will void your warranty.

• Any petroleum based lubricants. Doing so will damage the o-rings and will void your

warranty. If lubrication is required, the use of silicon spray is recommended.

WRAPS

Gently remove Heat Exchanger from the Sleeve. Hand wash the Sleeve in cold water,

using a mild detergent or antibacterial soap. Do not use fabric softener. Hang to dry.

If needed, the external surface of the Heat Exchanger may be cleaned by wiping down with

commercial non-bleach cleaning wipes or hand washed using a very small amount of mild

detergent or antibacterial soap. DO NOT MACHINE WASH.

Refer to the Wrap Use Guide accompanying individual Wraps for more information.

CARRY BAG

The Carry Bag should be cleaned using a soft cloth or brush and a mild detergent. Febreze®

or the equivalent can be used on the Bag if desired. If the Carry Bag has a biological material

on the surface, Steri-Fab® may be used to decontaminate those surfaces.

Be sure to test any product on a small portion of the Bag to ensure that it will not cause

damage.

Note: To operate the GRPro 2.1 System, you do not need to remove it from the Carry Bag.

Simply unzip the Bag’s main compartment and end panel. Fill the reservoir with ice and

water. Attach the Connector Hose and the AC Adapter to the end panel of the Control Unit

and plug the AC Adapter into an electrical outlet.

EN-13

Page 16

MAINTENANCE

The reservoir filter should be inspected, cleaned, and/or replaced as necessary.

1

Identify the filter within

the ice reservoir.

4

Rinse debris from the

filter and be sure there

are no obvious signs of

damage.

If you have questions

or would like to order

a new filter, 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 contact

your local distributor.

2

Using two fingers, grasp

and squeeze the two

protruding prongs.

3

Slide the filter out.

5

To replace the filter, or install

a new filter, first ensure

that the filter is oriented

properly with the plastic

tab facing up. If the filter is

not oriented properly, the

protruding tab will prevent

the filter from sliding back

into place.

6

You will feel and

hear the filter snap

back into place.

Other than maintaining the reservoir filter, no product service or modification should be

performed by the user. If your GRPro 2.1 System requires service, 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 contact your local distributor.

EN- 14

Page 17

ACCESSORIES

The GRPro 2.1 Control Unit can be used with any of the following accessories:

•

•

•

•

•

Any Game Ready Wrap using ATX Series Heat Exchangers (wraps made by any other

manufacturer CANNOT be used with this system)

Game Ready supplied FSP Group, Inc. Power Supply model FSP 030-RCAM and

Hospital Grade Power Cord or Mega MDM-030-A120-5396 power supply

Game Ready supplied Connector Hose

Game Ready Carry Bag

Game Ready Drain Mode Adapter

INDICATIONS FOR USE

Caution: United States Federal Law restricts this device to sale by or on the order of a

licensed health care practitioner.

• Follow the treatment recommendations of your health care practitioner for duration

and frequency of use for this device.

The GRPro 2.1 System combines cold and compression therapies. It is intended to treat

post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and

compression are indicated. It is intended to be used by or on the order of licensed healthcare

professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

CONTRAINDICATIONS

Important: Read the Wrap Use Guide for Wrap specific contraindications and warnings.

Compression Therapy using the Game Ready System 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 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 infraction, atrial fibrillation, endocarditis, myocardial

infarction, or artheromatous 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 System or any cryotherapy 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).

EN-15

Page 18

GENERAL WARNINGS AND CAUTIONS

WARNINGS

• Follow the treatment recommendations of your health care practitioner for duration and

frequency of use for this device.

• Improper placement or prolonged use of the Game Ready System could result in tissue

damage.

• 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.

• A layer of clothing between Wrap and skin is recommended for all patients.

• During the course of therapy, patients should monitor the skin of the treated region, the

surrounding area and the digits of the extremities of the treated limb (if applicable) for

any burning, itching, increased swelling, or pain. If any of these signs are 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 physiological 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.

Compression Therapy with the Game Ready System should be used only under the

supervision of a licensed healthcare practitioner 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) in the affected region.

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

• 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.

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.

EN- 16

Page 19

CAUTIONS

• To avoid the risk of electrical shock, do not remove any panels from the Control Unit.

Opening the case will void the Game Ready warranty. For all servicing and repair, 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 contact your local distributor.

• To avoid the risk of electrical shock, always turn off the system and disconnect the

power line cord from its electrical outlet when not in use or before adding or emptying

ice and water.

• Do not use any AC adapter other than that provided by Game Ready. Use of other

adapters may result in electrical shock and will void the Game Ready warranty.

• To avoid damage to your product, do not operate the system without any water in the

ice box.

• To avoid electrical shock, product malfunction or damage, never operate the system

with damaged power cords or Connector Hoses, or other mechanical damage, or if the

unit is otherwise not fully operational.

• To avoid potential damage to your product, do not pour hot water into the ice box. The

system is not designed to operate, and has not been tested, with hot water.

• Do not use anything but ice and water in the ice box.

• To avoid damage to your product, do not pick up the Control Unit by the lid. Carry the

Control Unit using the handle only.

• To avoid potential damage to your product, do not use other manufacturers’ wraps with

the Game Ready System.

• To avoid damage to your product, do not operate the Control Unit without a Connector

Hose attached.

• To avoid injury, be careful not to trip over the system’s power cords and Connector Hose.

• Monitor hose and cord placement when in use. Store hoses and cords when not in use

to avoid potential of strangulation.

• Keep the system, including hoses and cords, away from children and pets.

• Use caution when handling small parts to reduce any possibility of swallowing or

inhalation

• The GRPro 2.1 Control Unit is a technical medical device. To avoid damage to your

product, handle it with the same care as you would a laptop computer. Do not drop

it, kick it or otherwise abuse it unnecessarily. Such abuse will void all Game Ready

warranties. Do not place the AC Adapter or Battery Pack inside the ice box for storage or

transport.

• This symbol on the Control Unit or its packaging means that this product

must not be disposed of with your household waste. To learn where to drop

off your electrical and electronic waste, please contact your local city/

municipal waste disposal service office or contact Game Ready for

assistance.

• There are no special disposal requirements for the Wraps.

SPECIFICATIONS

Size: 16.25” length x 7.75” width x 9.25” height (413 x 197 x 235) mm, not including Carry Bag

Weight: 7.3 lb. empty, approximately 18 lb. full of ice and water

Pressure level: cycles from 5mm Hg up to 75mm Hg

AC power: 100-240 V~, 50-60 Hz, 1.6A

DC input: 12V/2.5 A

• The maximum operating temperature of the equipment is between 33.8-104ºF (1-40ºC).

• The maximum operating altitude of the equipment is 9,843 feet (3,000 meters).

• The expected service life of the Control Unit is 5 years. The expected service life of the

parts and accessories shipped with the Control Unit is 2 Years.

EN-17

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UL CLASSIFICATION

Protection against electric shock:

The GRPro 2.1 System is considered to be Class I (protective earth) when connected to

the FSP Group, Inc. model FSP 030-RCAM power supply and Class II when connected to

the Mega MDM-030-A120-5396 power supply.

The MDM-030-A120-5396 power supply is intended for home use. The FSP 030-RCAM

power supply is not intended for home use.

Protection against harmful ingress of water:

This product provides ordinary protection against ingress of water. When used with the

MDM-030-A120-5396 power supply the device is classified to an IP22 rating, which is a

protection against dripping water.

Pollution degree classification:

This product is classified as Pollution degree 2.

Degree of safety in the presence of flammable anesthetics or oxygen:

Not suitable for use in an oxygen enriched environment or in the presence of flammable

anesthetics.

Electromagnetic interference:

This equipment has been tested and found to comply with the limits for medical devices

in IEC 60601-1-2:2007 and IEC 60601-1-2:2014. These limits are designed to provide

reasonable protection against harmful interference in a typical medical installation.

This equipment generates, uses and can radiate radio frequency energy and, if not installed

and used in accordance with the instructions, may cause harmful interference to other

devices in the vicinity. However, there is no guarantee that interference will not occur in a

particular installation.

If this equipment does cause harmful interference to other devices, which can be

determined by turning the equipment off and on, the user is encouraged to try to correct

the interference by one or more of the following measures:

•

•

•

Reorient or relocate the receiving device.

Increase the separation between the equipment. Connect the equipment into an outlet

on a circuit different from that to which the other device(s) are connected.

Consult the manufacturer or field service technician for help.

The device is intended for use in orthopedic centers, therapy clinics, athletic training

facilities, hospitals, nursing facilities, medical centers, as well as in patient homes. The

device should not be used in an environment where the intensity of electromagnetic

disturbance is high.

In the event the device experiences a loss of performance or degradation due to

electromagnetic disturbance, the device is expected to continue to operate safely.

The device should not be used less than 30 cm (12 inches) away from any portable and

mobile RF communications equipment.

EN- 18

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ELECTROMAGNETIC COMPATIBILITY

Electromagnetic Compatibility Information According to IEC/EN 60601-1-2

Table 1 for Emissions

GUIDANCE AND MANUFACTURER’S DECLARATION –

ELECTROMAGNETIC EMISSIONS

The GRPro 2.1 is intended for use in the electromagnetic environment specified below. The

customer or the user of the GRPro 2.1 should assure that it is used in such an environment.

EMISSIONS TEST

RF emissions CISPR 11

COMPLIANCE

ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

Group 1

The GRPro 2.1 uses RF energy only for its

internal function. Therefore, its RF emissions

are very low and are not likely to cause any

interference in nearby electronic equipment.

The GRPro 2.1 is suitable for use in all

establishments, including domestic

establishments and those directly connected

to the public low-voltage power supply

network that supplies buildings used for

domestic purposes.

RF emissions CISPR 11

Class B

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

flicker emissions IEC

61000-3-3

Complies

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Page 22

Table 2 for Transient Electromagnetic Immunity

GUIDANCE AND MANUFACTURER’S DECLARATION –

ELECTROMAGNETIC IMMUNITY

The GRPro 2.1 is intended for use in the electromagnetic environment specified below. The

customer or the user of the GRPro 2.1 should assure that it is used in such an environment.

IMMUNITY TEST

IEC 60601 TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV for power

supply lines

± 1 kV for input/

output lines

± 2 kV for power

supply lines

± 1 kV for input/

output lines

Mains power quality should be that

of a typical commercial or hospital

environment.

Surge

IEC 61000-4-5

± 1 kV line(s) to

line(s)

± 2 kV line(s) to

earth

± 1 kV line(s) to

line(s)

± 2 kV line(s) to

earth

Mains power quality should be that

of a typical commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

<5% UT

(>95% dip in UT)

for 0.5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

<5% UT

(>95% dip in UT)

for 5 s

<5% UT

(>95% dip in UT)

for 0.5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

<5% UT

(>95% dip in UT)

for 5 s

Mains power quality should be that

of a typical commercial or hospital

environment. If the user of the GRPro

2.1 requires continued operation

during power mains interruptions, it is

recommended that the GRPro 2.1 be

powered from an uninterruptible power

supply or a battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical commercial

or hospital environment.

NOTE UT is the AC mains voltage prior to application of the test level.

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Page 23

Table 3 for RF Electromagnetic Immunity

GUIDANCE AND MANUFACTURER’S DECLARATION –

ELECTROMAGNETIC IMMUNITY

The GRPro 2.1 is intended for use in the electromagnetic environment specified below. The

customer or the user of the GRPro 2.1 should assure that it is used in such an environment.

IMMUNITY TEST

IEC 60601 TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

Portable and mobile RF communications

equipment should be used no closer to

any part of the GRPro 2.1, including cables,

than the recommended separation distance

calculated from the equation applicable to

the frequency of the transmitter.

Conducted RF

IEC 61000-4-6

3 Vrms

3Vrms

150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

3 V/m

3 V/m

80 MHz to 2.5 GHz

Recommended separation distance

d = 1.2 √P 80 MHz to 800 MHz

d = 1.2 √P 80 MHz to 800 MHz

d = 2.3 √P 800 MHz to 2.5 GHz

where P is the maximum output power

rating of the transmitter in watts (W)

according to the transmitter manufacturer

and d is the recommended separation

distance in meters (m).

Field strengths from fixed RF transmitters,

as determined by an electromagnetic

site survey,a should be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of

equipment marked with the following

symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast

cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to

fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field

strength in the location in which the GRPro 2.1 is used exceeds the applicable RF compliance level

above, the GRPro 2.1 should be observed to verify normal operation. If abnormal performance is

observed, additional measures may be necessary, such as re-orienting or relocating the GRPro 2.1.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

a

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Page 24

Table 4 for RF Immunity

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE

AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE GRPRO 2.1

The GRPro 2.1 is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the GRPro 2.1 can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile

RF communications equipment (transmitters) and the GRPro 2.1 as recommended below,

according to the maximum output power of the communications equipment.

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER

RATED MAXIMUM OUTPUT

POWER OF TRANSMITTER

150 KHZ TO 80 MHZ

80 MHZ TO 800 MHZ

800 MHZ TO 2.5 GHZ

W

d = 1.2 √P

d = 1.2 √P

d = 2.3 √P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in meters (m) can be estimated using the equation applicable to the frequency of the

transmitter, where P is the maximum output power rating of the transmitter in watts (W) according

to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

WARNINGS:

Medical Electrical Equipment needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided in the User’s

Manual.

Portable and mobile RF communications equipment can affect Medical Electrical

Equipment.

The GRPro 2.1 System has to be powered with the AC adapter FSP Group Inc. model

FSP 030-RCAM or Mega MDM-030-A120-5396 power supply in order to be compliant

with IEC/EN 60601-1-2 section 6.1 and 6.2.

The use of accessories, transducers and cables other than those specified and sold

by the manufacturer of the GRPro 2.1 System as replacement parts for internal

components may result in increased emissions or decreased immunity of the medical

electrical system.

The GRPro 2.1 System should not be used adjacent to or stacked with other equipment.

If adjacent or stacked use is necessary, the GRPro 2.1 System should be observed to

verify normal operation in the configuration in which it will be used.

EN- 22

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WARNING: The essential performance of the GRPro 2.1 System is:

Pneumatic Compresion Cycles:

• High: cyclic 5-75mm Hg

• Med: cyclic 5-50 mm Hg

• Low: cyclic 5-15 mm Hg

• NO Pressure: Wrap shall be vented to atmosphere

• Air Pressure Accuracy: ±10 mm Hg

The cooling temperature of the circulating ice water will be adjustable between

34°F (1°C) and 50°F (10°C) as long as the ice water in the ice box is supplied

with sufficient amount of ice.

• Water Temperature Accuracy: ±2 °F (±1.1 °C)

EN-23