Game Ready 500055, 550350 User manual

CONTROL UNIT

User’s Manual

MODEL 500055

GAME READY CONTROL UNIT

MODEL 550350

PRE-PROGRAMMED CONTROL UNIT

THE GAME READY DIFFERENCE

Game Ready® was built upon the concept that the principles behind spacesuit technology could be used to develop an injury treatment system. As a designer for NASA and an inductee into the U.S. Space Foundation’s Hall of Fame, our founder helped pioneer the technology involved in controlling pressure and temperature within a flexible garment. In 1998, we began working with athletes, athletic trainers, doctors, and engineers to expand breakthrough discoveries into the realm of sports medicine.

INDICATIONS FOR USE

The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Please complete and return the Warranty Registration cards for both the Game Ready Control Unit and the Wraps. The Control Unit registration card is located behind the front cover of this manual, and the Wrap registration card is packaged with the heat exchanger of each Wrap. You may also go to www.gameready.com to register your product. You must register within 30 days from the date of purchase in order to receive warranty service.

Let us know what you think of our products. We’d love to hear from you.

Game Ready

CoolSystems Inc.

1201 Marina Village Pkwy. Ste. 200

Alameda, CA 94501

Phone number:

1.888.GameReady

1.888.426.3732

+1.510.868.2100

www.gameready.com

EN-1

TABLE OF CONTENTS

INDICATIONS FOR USE _______________________________________ 1

CONTRAINDICATIONS ________________________________________ 3

GENERAL WARNINGS AND PRECAUTIONS _____________________ 3

THE GAME READY SYSTEM

Your Game Ready System _____________________________ 6 Control Panel/Basic Controls ___________________________ 7 Priming a New Wrap __________________________________ 7 Control Unit Set Up ___________________________________ 8 Wearing the Wraps ___________________________________ 9

IMPORTANT USER GUIDELINES _______________________________ 10

GETTING STARTED __________________________________________ 11

ADJUSTING SYSTEM SETTINGS ______________________________ 13

OPERATING THE SYSTEM IN THE BAG ________________________ 14

POWERING THE SYSTEM ____________________________________ 14

CARE AND STORAGE

Cleaning, Storage and Transportation ___________________15 Cleaning and Replacing the Filter ______________________ 15 Wrap Care and Storage _______________________________ 16

TROUBLESHOOTING _________________________________________ 17

WARRANTY INFORMATION: CONTROL UNIT __________________ 20

PRODUCT SPECIFICATIONS __________________________________ 21

HOW TO CONTACT US ______________________________________ 21

EN-2

CONTRAINDICATIONS

• Compression Therapy (vasopneumatic compression) using Game Ready 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 history or risk factors for deep vein thrombosis or pulmonary embolus (including prolonged bed rest) in the affected region (to be treated with this therapy)

- Who have a cardiac insufficiency or congestive heart failure (with associated edema in the extremities or lungs)

- Who have significant arteriosclerosis or other vascular ischemic disease in the affected region

- Who have a localized skin condition (eg, dermatitis, vein ligation, gangrene, skin graft) in the affected region

- Who have a condition in which increased venous or lymphatic return is not desired in the affected extremity (eg, carcinoma)

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

- Who have decompensated hypertonia in the affected region

• Cryotherapy using Game Ready or any cryotherapy device should not be used in patients:

- Who have significant vascular impairment in the affected region (eg, from prior frostbite, diabetes, arteriosclerosis or ischemia)

- Who have acute paroxysmal cold hemoglobinuria or cryoglobulinemia

GENERAL WARNINGS AND PRECAUTIONS

Thank you for choosing the Game Ready System. To assure you have the best experience possible, please be sure to read the entire User’s Manual prior to use of the product.

Caution: Federal Law restricts this device to sale by or on the order of a licensed health care practitioner.

WARNINGS

• Improper placement or prolonged use of Game Ready could result in tissue damage such as frostbite.

• During the course of Game Ready therapy, patients should monitor the skin surrounding the treated region or the digits of the extremities of the treated limb for any burning, itching, increased swelling, or pain. If any of these signs present, or any changes in skin appearance occur (such as blisters, increased redness, discoloration, or other noticeable skin changes), patients are advised to discontinue use and consult a physician.

• The Game Ready Wrap is not sterile; do not place directly against open wounds, sores, rashes, infections, or stitches. May be applied over clothing or dressing.

• Compression Therapy (vasopneumatic compression) with the Game Ready System should be used only under the supervision of a licensed healthcare practitioner in patients:

- Who have a 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

• 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 uticaria)

- 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 are children or who have cognitive disabilities or communication barriers

- Who have rheumatoid arthritis in the affected region

- Who have known and un-controlled peptic ulcer (if the affected region is the abdominal region) since cold therapy applied to the abdomen can cause increased gastrointestinal motility and gastric acid secretion

EN-3

WARNINGS CONT.

• You should not operate a vehicle or heavy machinery while using the Game Ready System.

• To avoid the risk of electrical shock, do not remove any panels from the Control Unit. Refer all servicing and repair to Game Ready Customer Service at 1.888.426.3732. Opening the case will void the Game Ready warranty.

• Never operate the System with damaged power line cords or connector hoses.

• Always turn off the System and disconnect the power line cord from its electrical outlet when not in use or before adding ice and water.

• Do not use any adapter other than that provided by Game Ready. Use of other adapters may result in electrical shock and will void the Game Ready warranty.

• Be careful not to trip over the System’s power cords and connector hose.

• Be mindful of the power cords and connector hoses to avoid any risk of strangulation.

PRECAUTIONS

• Do not operate the System without any water in the ice box.

• Do not pour hot water into the ice box.

• Do not pick up the Control Unit by the lid. Carry using the handle only.

• Do not use any wraps designed by other manufacturers with the Game Ready System.

• The Game Ready Control Unit is a technical medical device. 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.

In addition to the precautions listed above, additional warnings and safety precautions are posted throughout this manual. Read and carefully follow these instructions prior to operating the System.

EN-4

UL SAFETY CLASSIFICATION INFORMATION

1. Protection against electric shock (5.1)

The Game Ready power supply (Ault Model MW128) provides Class I (grounded) equipment protection.

The Game Ready power supply (GlobTek Model GTM21097-5012) provides Class II (ungrounded) equipment protection.

2. Protection against harmful ingress of water (5.3)

This product provides ordinary protection against ingress of water.

3. Degree of safety in the presence of flammable anesthetics or oxygen (5.5)

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

4. Mode of operation (5.6)

The equipment operates under continuous operation and continuous operation with intermittent loading if operating the system continuously without a full load of ice. Users should allow the system to rest for at least 15 minutes between each 90-minute treatment.

5. Electromagnetic Interference:

This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2:1994. 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.

EN-5

Medical Equipment With respect to electrical shock, fire, and mechanical hazards only in accordance with UL 60601-1, CAN/CSA C22.2 No. 601.1 <61ZJ>

Type B Applied Parts

Attention: Consult accompanying documents before use

Manufacturer

Control Unit

Heat Exchanger

YOUR GAME READY SYSTEM

Sleeve

Carry Bag

(optional)

Connector

Hose

AC Adapter

User’s Manual

CONTROL UNIT ORIENTATIONS

Figure A: Upright

The Control Unit can sit upright (Fig. A) or on one side (Fig. B) to fit on a shelf.

Caution: Do not put the unit on the side where the control panel is upside down. This will cause the unit to leak water.

Note: 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.”

Figure B: Side

EN-6

+ 15 hidden pages