English User Manual
Contents
1. TROUBLESHOOTING WHAT DOES WHAT CAN ERROR IT MEAN 1 DO Air Pressure Sensor The This is most likely to occur if you have J Control Unit has detected a restarted the System with an inflated Wrap A problem calibrating the air attached LI pressure circuit on start up Detach the Wrap pressing it flat to expel the air accumulated inside and try again Self Test Error Air Disconnect the Wrap from the Control Unit l1 Pump The Control Uni Turn the Control Unit off and on again gm has detected an electronic without a Wrap connected LI L problem in the air circuit on Reconnect the Wrap and resume treatment If the problem persists contact Customer Service start up Dry Pump The Control Unit Be sure you are using ATX Series Heat has detected a dry pump Exchangers In order to prevent possible Note that if you are using new Wraps damage to the fluid pump the water in the reservoir may have been the unit will stop therapy depleted and causing this error Make sure there is adequate water in the reservoir based on the fill line indicator label Refer to instructions for priming a Wrap below Verify that the ice box filter is not clogged refer to filter maintenance instructions on page 12 Make sure there are no kinks in the Wrap or Connector Hose Turn the Control Unit off and on again Disconnect and reconnect the hose from the Control Unit and the Wrap verifying2. for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for5s Mains power quality should be tha 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 Uris the AC mains voltage prior to application of the test level EN 18 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 Recommended separation distance Conducted RF 3 Vrms 3Vrms d 1 2 YP 80 MHz to 800
3. G Set the pressure by pushing the pressure button You can select Medium Pressure 5 50 mmHg High Pressure 5 75 mmHg 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 3 in this manual for details 10 D Press play pause button to start your Game Ready treatment with ACCEL Technology Press play pause at any time to stop your treatment a Set to your target temperature displayed in the 5 x Target Temperature window by turning the knob More Less For coldest therapy turn the knob clockwise towards vod colg three snowflakes For warmer therapy turn the knob a counterclockwise towards one snowflake a Replenish ice and water levels as necessary and indicated in Step 2 to maintain your target temperature EN 9 When you are done using t
4. he Control Unit and the Wrap verifying hat an audible click is heard at both connection points f that does not solve the problem turn the Control Unit off for 20 minutes to let the pump cool down before turning it on again o try again gt Low Flow Control Unit has detected something blocking the water flow Check all hose connections Make sure there is water in the ice box Verify that the ice box filter is not clogged Be sure you are using ATX Series Heat Exchangers Disconnect and reconnect Wrap from Connector Hose Make sure there are no kinks in the Wrap or Connector Hose Reapply the Wrap snugly making sure to follow all application instructions accompanying the Wrap Turn the Control Unit off and on again Disconnect and reconnect the hose from the Control Unit and the Wrap EN 22 WHAT DOES IT MEAN Self Test Error Fluid Circuit The Control Unit has detected an electronic problem in the fluid circuit on start up WHAT CAN I DO Turn off the Control Unit Turn the Control Unit back on and resume treatment If the problem persists contact Customer Service Temperature Calibration Error The Control Unit has detected a failure in the Temperature Control circuit or is being operated outside of the advised temperature range 33 120 degrees Fahrenheit Be sure you are operating and storing the System within the advised temperature ran
5. 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 f 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 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 Push the door release button to open the ice box door EN 6 Add water to fill line indicated on label within the reservoir DO NOT OVERFILL Add ice to top of reservoir Place the Control Unit in the location where you plan to use it The Control Unit should only be used in
6. button to select either Celsius or Fahrenheit on the temperature display DOO CO0 CO GO OO Backlight Use this button to turn the backlight on or off EN 3 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 Vol qp 9 x Manual ef i7 m Manual Lt gt Indicates selected mode Program Program Pause BE Pause ME Play p Play E Other Icons Error A Indicates an error See troubleshooting pages 21 23 for error codes ndicates unit is paused ndicates unit is running Sleep O Indicates sleep mode time Battery OU Indicates remaining battery capacity Temperature Actual Temperature Approximate temperature of the water leaving the Control Unit Target
7. that an audible click is heard at both connection points Prime the Wrap using the following steps Select No Pressure Attach the hose to the unit and the wrap Lay the Wrap open and flat next to or lower than the Control Unit not on the body Run the System for 2 minutes Prime the Control Unit using the following steps Disconnect the hose from the Control Unit Now look at the Wrap connection location on the Control Unit On the top valve push the white prong in so that it is flush with the metal connector Make sure you are not fully covering the opening in the prong Push start and water should squirt out of the valve Restart the System A A Over Pressure Indicates Turn the Control Unit off and back on i LL that the Control Unit has Make sure the Wrap is applied securely A wem exceeded the target air Do not make sudden movements during ti pressure treatments Rapid shifting in position may dem ee produce a quick change in pressure in the Wrap and cause this error EN 21 WHAT DOES IT MEAN Under Pressure The Control Unit can t reach its target maximum compression This often indicates that there is a leak in the pneumatic compression circuit either in the Connector Hose Wrap or Control Unit Or it may occur because the hook and loop fastener on your Wrap has worn out Make sure the Wrap is applied securely WHAT CAN
8. 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 n to fully empty the ice box Drain Mode is indicated by the following icons zZ 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 9 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
9. ED TO REPAIR OR REPLACEMENT AS SET FORTH ABOVE THESE REMEDIES ARE THE SOLE AND EXCLUSIVE REMEDIES FOR ANY BREACH OF WARRANTY COOLSYSTEMS IS NOT RESPONSIBLE FOR DIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR UNDER ANY OTHER LEGAL THEORY INCLUDING BUT NOT LIMITED TO LOST PROFITS DOWNTIME GOODWILL AND DAMAGE TO OR REPLACEMENT OF EQUIPMENT AND PROPERTY SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU THIS LIMITED WARRANTY GIVES YOU SPECIFIC RIGHTS AND YOU MAY ALSO HAVE OTHER RIGHTS THAT VARY FROM JURISDICTION TO JURISDICTION WARRANTY REGISTRATION The GRPro2 1 Control Unit comes with a 2 year warranty from date of purchase The Heat Exchanger Connector Hose AC Adapter and Power Cord come with a 1 year warranty In the case of a manufacturer s defect the wrap sleeve and sleeve accessories may be returned within 7 days of purchase REGISTRATION Please complete the Warranty Registration within 30 days for both the GRPro 2 1 Control Unit and the Wraps online at www gameready com You will need the following information to complete your Warranty Registration The Control Unit s model number REF and its serial number SN These numbers are located on the label on the bottom of the Control Unit Simply go to www gameready com visit the Product Registration page fill out the
10. GAME G2 READY GRPro 21 CONTROL UNIT User s Manual MODEL NUMBERS 550550 03 550550 03 RN 550550 53 This User s Manual is also available online in English French German Italian Japanese Spanish Portuguese Arabic Russian Dutch Hungarian and Turkish at www gameready com under Support DESCRIPTION OF THE GR PRO 2 1 SYSTEM The following items are included in your GRPro 2 1 System Power Cord Connector GRPro 2 1 Hose Control Unit with ACCEL Technology AT3 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 Pressure Indicator Power Pressure Backlight Indicator Actual Oo UN Temperature Power Ns Volume Clas Program Program I Temperature Pause Knob Play te Pause i s Sim Mme Temperature Target C F Celsius Fahrenheit Temperature Subtract Add Time Time Manual Mode TABLE OF CONTENTS Introduction to Game Ready 2 Detailed Instructions for Use 3 Modes of Operation 3 Buttons 3 Adjusting Temperature 4 Display 4 Operating the System 6 Storage 10 Cleaning 10 Maintenance 12 Accessories 13 Indications for Use 13 Contraindications 13 General W
11. I DO Try using a different Wrap and Hose to isolate which component may be producing the error For example an error which occurs with a Shoulder Wrap but not a Knee Wrap may indicate that the Shoulder Wrap is causing the error not the Control Unit If using a Dual Hose make sure you have wo Wraps attached Deflation Error The Control Unit has detected that the Wrap has not properly deflated Turn the Control Unit off f there is air left in the Wrap disconnect he Wrap from the Connector Hose and manually deflate the Wrap by applying pressure to it Reconnect the Hose to the Wrap and reapply the Wrap to the body Turn the Control Unit on and press play pause Make sure the Wrap is applied securely against the body f possible try using a different Wrap and Hose to isolate which component may be producing the error For example an error which occurs with a Shoulder Wrap but not a Knee Wrap may indicate that the Shoulder Wrap is causing the error not the Knee Wrap or Control Unit e Pump Performance Error The Control Unit has determined that the fluid pump may be working too hard This could be caused by ice or debris in the fluid circuit In order to prevent possible damage to the fluid pump the unit will stop therapy Turn the Control Unit off and back on again Reapply the Wrap making sure to follow all application instructions accompanying the Wrap Disconnect and reconnect the hose from
12. IONS 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 ine 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 no
13. MHz IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 2 YP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3VP 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 9 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 a 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 o
14. Temperature Indicates the target temperature setting The Control Unit will automatically match the Actual Temperature and Target Temperature as closely as possible on BB EN 4 When the System is running in Program Mode When the System Pressure Sleep time count down bars N Displays the amount of run time remaining Run time count down bars Displays the amount of sleep time remaining Play ME 0 Displays the amount of run time is running in 40 MA Manual Mode remaining When selecting a Displays pressure program Pressure off low Med High Actual r o u w Vw Temperature NC 55 13 J Volume cy 9 NAONNANA 50 10 Manual 5 s Program 4 5 Pase MM Mia Displays amount of time unit will sleep Off Low Med Target Temperature Sleep Time Run Time Displays amount of time unit will run Off Low Med High uw Ol Off Low Med High um Off Low Med High ue eo umi High EN 5 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
15. arnings and Cautions 14 Specifications 15 UL Classification 16 Electromagnetic Compatibility 17 Troubleshooting 21 Warranty 24 Warranty Registration 25 EN 1 INTRODUCTION TO GAME READY Based in Concord California and founded in 1998 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 Tec
16. cted to the FSP Group Inc model FSP 030 RCAM power supply Protection against harmful ingress of water This product provides ordinary protection against ingress of 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 Game Ready System as to electrical shock fire and mechanical hazards only in accordance with EN 60601 2006 CAN CSA C22 2 No 60601 1 2008 and ANSI AAMI ES60601 2005 C1 09 A2 10 Powered by Direct Current Type BF Applied Parts Attention Consult Instructions for Use o eee MADE IN Symbol for made in a specific country XXXX Symbol for assembled in a specific country XXXX Electromagnetic interference This equipment has been tested and found to comply with the limits for medical devices in IEC 60601 1 2 2001 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 b
17. e at 1 888 426 3732 1 510 868 2100 from outside of the U S please contact your local distributor ES RN Using two fingers grasp and squeeze the two protruding prongs Br 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 RN B Slide the filter out CQ BN You will feel and hear the filter snap back into place Other than maintaining the reservoir filter no product service 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 12 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 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 Fol
18. e 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 EN 16 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 flicker emissions IEC 61000 3 3 EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The GRPro 2 1uses 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 RF emissions CISPR 11 Class B The GRPro 2 1 is suitable for use in all Harmonieemission Class A establishments including domestic IEC 61000 3 2 establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic Voltage fluctuations Complies
19. equently and stirring the reservoir to break up large formations of ice if necessary Make sure here are no kinks in the Wrap or Connector Hose Reapply the Wrap making sure to follow all accompanying application instructions Finally if you still cannot achieve the coldest emperature desired adding more water han what is indicated by the reservoir fill line abels may also allow the Control Unit to reach colder temperatures To achieve this effect water may be added to the top of the ice level CAUTION By overfilling the reservoir as in the ast step the temperature control feature of the System will not work and the Control Unit will be administering therapy at full cold Consult he Warnings on page 14 to make sure you ake proper steps to minimize the risk of injury Need more help with a problem 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 23 WARRANTY MANUFACTURER S WARRANTY CoolSystems warrants that the GRPro 2 1 Control Unit if properly used will be free from defects in material and workmanship for a period of two 2 years after the date the GRPro 2 1 Control Unit was purchased If the GRPro 2 1 Control Unit which is the subject of this Limited Warranty malfunctions during the warranty period for reasons covered by this Limited Warranty CoolSystems at its options will REPAIR the GRPro 2 1 Control Un
20. form and submit your information EXTENDED WARRANTIES Extended Warranties are available for the GRPro 2 1 System For details and information 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 A list of current patent s covering Game Ready technology can be found at www gameready com patents EC REP EMERGO EUROPE Molenstraat 15 Th 0086 The Netherlands EN 25 GAME G2 READY wal CoolSystems Inc 1800 Sutter Street Suite 500 Concord CA 94520 USA 1 888 GameReady 1 888 426 3732 1 510 868 2100 www gameready com Game Ready Control Unit User s Manual PN 703995 Rev B 2014 CoolSystems Inc All rights reserved
21. ge of 33 120 degrees Fahrenheit Turn the Control Unit off Fill the Control Unit with ice and water per the label instructions inside the reservoir Turn the unit back on again and push Play Pause Repeat this process up to three times If the problem persists contact Customer Service Control Unit will not turn on Press the power button If no orange or green light is illuminated make sure the AC Adapter is plugged into a working electrical outlet and all connections are secure Test outlet with another electrical device Press the power button again If the Control Unit still will not turn on call Customer Service Control Unit won t reach Target Temperature or temperature is unstable The fillline labels within the reservoir indicate an ice water ratio that will assist the Control Unit in achieving the temperature you ve specified using the Temperature Knob If you have filled the Control Unit according to the fill line labels and are still unable to achieve your desired target temperature try the following steps f you are still unable to achieve WARMER emperatures be sure the Temperature Knob is turned to full warm use less ice and reduce he amount of water if necessary f you are still unable to achieve COLDER emperatures be sure the you are using ATX Series Heat Exchangers Confirm that the Temperature Knob is set to full cold and hat the reservoir is full of ice replenishing r
22. he 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 Storage Temperature Conditions 33 120 F 1 50 C Relative Humidity 1096 9596 non condensing Caution Do not keep in extreme cold or hot temperatures below 33 F or above 120 F or below 1 C 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 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 e 70 Isopropyl alcohol 100 Simple Green e 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 d
23. hnology 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 The Wrap registration card is packaged with the Heat Exchanger of each Wrap Further warranty information can be found in the Warranty Section of this manual DON T JUSTTREAT SYMPTOMS HELP ACCELERATE HEALING To learn more or to share your experience with the Game Ready System please call us at 1 888 426 3732 or email us at info gameready com We d enjoy hearing from you 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 ON PAGES 13 15 BEFORE USING THIS PRODUCT EN 2 DETAILED INSTRUCTIONS FOR USE Do not use this device wi
24. it OR REPLACE the GRPro 2 1 Control Unit with another GRPro 2 1 Control Unit THIS LIMITED WARRANTY AND ANY IMPLIED WARRANTIES THAT MAY EXIST UNDER STATE LAW APPLY ONLY TO THE ORIGINAL PURCHASER OF THE GR PRO 2 1 CONTROL UNIT AND ARE NON TRANSFERABLE Extent of Limited Warranty This limited warranty does not cover damages due to external causes including without limitation accident usage not in accordance with product instructions misuse neglect alteration or repair How to Obtain Warranty Service To obtain warranty 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 If you are not sure who the local distributor is call Game Ready Customer Service at 1 510 868 2100 and we will refer you to one You must have returned the Warranty Registration card to CoolSystems within thirty 30 days from the date of purchase to qualify for warranty service If you qualify for warranty service from CoolSystems you will be issued a Returned Material Authorization RMA number When you return the GRPro 2 1 Control Unit to CoolSystems you must write the RMA number on the outside of the package CoolSystems will not accept returned GRPro 2 1 Control Units without an RMA number on the package If you return the GRPro 2 1 Control Unit to CoolSystems you must assume the risk of damage or loss during shipping You must use the original packaging or the eq
25. low 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 wrap user manual 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 pa
26. ly deflated prior to each application 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 Disconnect Button If you have any problems with the set up of your G Game Ready Customer Service at 1 888 426 3732 of the U S please contact your local distributor Warnings Follow the treatment recommendations o for the use of this device RPro 2 1 System in the U S call 1 510 868 2100 from outside your health care practitioner Improper placement or prolonged use of the GRPro 2 1 could result in tissue damage For additional warnings and precautions p of this manual ease refer to pages 14 amp 15 EN 8 LI J 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 Select the operating mode You can choose either Manual Mode or Program Manual Mode Set the time in five minute increments by pushing the buttons from 4 pressure settings No pressure Low Pressure 5 15 mmHg
27. omagnetic 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 in order to be compliant with IEC EN 60601 1 2 section 6 1 and 6 2 EMC requirements 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 The essential performance of the GRPro 2 1 System is Compression Cycle High cyclic 5 75 mm Hg Med cyclic 5 50 mm Hg Low cyclic 5 15 mm Hg NO Pressure wrap shall be vented to atmosphere 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 EN 20
28. pression 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 e 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 EN 14 CAUT
29. purposes 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 COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE IEC 60601 TEST LEVEL Electrostatic discharge ESD IEC 61000 4 2 6 kV contact x 8 kV air x 6 kV contact x 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 3096 Electrical fast x 2 kV for power x 2 kV for power Mains power quality should be tha transient burst supply lines supply lines of a typical commercial or hospital IEC 61000 4 4 1 kV for input 1 kV for input environment output lines output lines Surge x 1 KV line s to x 1 KV line s to Mains power quality should be tha IEC 61000 4 5 line s line s of a typical commercial or hospital 2 kV line s to earth 2 kV line s to earth environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ut 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for5s 596 Ur gt 95 dip in Ur
30. rienting or relocating the GRPro 2 1 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m EN 19 Table 4 for RF Immunity RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE GR PRO 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 d 1 2 P FERIA d 2 3 VP 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 73 100 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 Electr
31. ry thoroughly before storing it in the bag The Control Unit should be cleaned as needed DO NOT USE e 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 10 CONNECTOR HOSE The surface of the Connector Hose can be cleaned using a soft cloth and one of the following Mild detergent Steri Fab e 70 Isopropyl alcohol We do not recommend the use of quaternary ammonium such as Virex or Cavicide DO NOT USE e 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 wa
32. t 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 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 x235 mm not including Carry Bag Weight 73 lb empty approximately 18 Ib full of ice and water Pressure level cycles from 5 mm Hg up to 75 mm 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 8 104 F 1 40 C The maximum operating altitude of the equipment is 8 000 feet 2 500 meters EN 15 UL CLASSIFICATION Protection against electric shock The GRPro 2 1 System is considered to be Class protective earth when conne
33. ter 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 a grounded electrical outlet EN 11 MAINTENANCE The reservoir filter should be inspected cleaned and or replaced as necessary P RS Identity the filter within the ice reservoir 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 Servic
34. the upright orientation as shown The Control Unit will leak if placed on its side Connect the AC Adapter to the receptacle on the end panel of the Control Unit then plug the AC Adapter into a grounded electrical outlet The power indicator light orange color on the Control Unit should illuminate Press the power button 6 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 23 of the Troubleshooting Guide in this manual Note The Control Unit should be turned on prior to attaching a Wrap AC Adapter to electrical outlet gt J EN 7 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 Connector Hose to Wrap gt 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 dressing rashes infections or stitches The Wrap may be applied over clothing or To ensure best fit be sure the Wrap is complete
35. thout 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 Be sure to read further safety warnings on pages 14 15 of this User s Manual MODES OF OPERATION Manual Mode The System autornatically 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
36. tients 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 13 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 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 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 Com
37. uivalent CoolSystems may require you to verify in writing that you are the original purchaser of the GRPro 2 1 Control Unit CoolSystems may elect to replace or repair the GRPro 2 1 Control Unit with either a new or reconditioned product The returned product shall become CoolSystems property upon receipt The replacement GRPro 2 1 Control Unit is warranted under this written warranty and is subject to the same limitations and exclusions for the remainder of the original warranty period THIS WARRANTY IS NOT TRANSFERABLE WARRANTY LIMITATIONS AND EXCLUSIONS THESE WARRANTIES REPLACE ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE COOLSYSTEMS MAKES NO EXPRESS WARRANTIES BEYOND THOSE STATED HERE COOLSYSTEMS DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES SO THIS LIMITATION MAY NOT APPLY TO YOU ALL EXPRESS AND IMPLIED WARRANTIES ARE LIMITED IN DURATION TO THE LIMITED WARRANTY PERIOD NO WARRANTIES APPLY AFTER THAT PERIOD SOME JURISDICTIONS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS SO THIS LIMITATION MAY NOT APPLY TO YOU EN 24 LIMITATIONS OF LIABILITY COOLSYSTEMS RESPONSIBILITY UNDER THIS OR ANY OTHER WARRANTY IMPLIED OR EXPRESS IS LIMIT
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