User Manual
84 Pages
Preview
Page 1
USER MANUAL
Model Number 650550
United States Federal Law restricts this device to sale by, or on the order of, a licensed health care practitioner.
The Med4 Elite User Manual may be updated from time to time. The most current version of the User Manual can be found online in various languages at www.gameready.com. If you require a paper copy of this manual, contact Game Ready Customer Service at 1.888.426.3732. International customers contact your local distributor. دليل المستخدم هذا متوفر بلغات عدة على الموقع 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
WELCOME TO MED4 ELITE
CONTENTS
Introduction to the Med4 Elite™
Compression-Only Therapy������������������������������������������������ 28
Indications for Use�����������������������������������������������������������������2
Pausing, Changing, and Stopping a Therapy���������������������� 30
Features ��������������������������������������������������������������������������������3
Powering Down������������������������������������������������������������������� 31
Compression Levels��������������������������������������������������������������3
Configuring Med4 Elite System Settings
Illustrations ����������������������������������������������������������������������������4
Personal Identification Number (PIN)����������������������������������32
Included Hardware and Documentation��������������������������������5
Changing the PIN�������������������������������������������������������������32
Definitions����������������������������������������������������������������������������� 6
Setting Defaults������������������������������������������������������������������ 33 Accessing System Settings��������������������������������������������� 36
Safety Med4 Elite Contraindications�������������������������������������������������7
Heat Settings�������������������������������������������������������������������37
General Warnings and Cautions������������������������������������������� 8
Cold Settings������������������������������������������������������������������� 40
System Warnings and Cautions�������������������������������������������� 9
Snooze Function... 43
Getting Started Setting Up����������������������������������������������������������������������������10 Filling the Reservoirs�����������������������������������������������������������10 Powering Up������������������������������������������������������������������������10 Setting the Language���������������������������������������������������������� 11 Changing Factory Settings��������������������������������������������������12 Personal Identification Number (PIN)����������������������������������12
Med4 Elite At A Glance User Interface Elements������������������������������������������������������13 Therapy Icons�����������������������������������������������������������������������14 System Settings Icons���������������������������������������������������������15
Using the Med4 Elite
Rapid Contrast Settings�������������������������������������������������� 44 Compression-Only Settings�������������������������������������������� 50 Resetting the Med4 Elite to Factory Settings���������������������52 Changing the Language������������������������������������������������������ 53 Working With Med4 Elite System Software and Information ������������������������������������� 54 Viewing System Information������������������������������������������� 54 Downloading Data����������������������������������������������������������� 55 Updating the System Software �������������������������������������� 56
Storing, Cleaning and Maintaining the Med4 Elite Storing��������������������������������������������������������������������������������� 58 Cleaning and Maintaining���������������������������������������������������� 59 Control Unit and Connector Hoses��������������������������������� 59
Setting the Temperature������������������������������������������������������16
Control Unit Reservoirs��������������������������������������������������� 59
Setting the Temperature Scale (°F / °C)�������������������������������16
Control Unit Filter������������������������������������������������������������ 60
Setting Up Therapy Sessions����������������������������������������������16
Wraps������������������������������������������������������������������������������ 60
Single Patient Therapy with One Wrap���������������������������� 17
Adding Distilled Water ��������������������������������������������������������61
Single Patient Therapy with Two Wraps��������������������������18
Water Reservoir Levels����������������������������������������������������61
Two Patient Therapy���������������������������������������������������������18
Transporting the Med4 Elite ������������������������������������������������62
Heat Therapy���������������������������������������������������������������������� 20
Moving Within the Facility�����������������������������������������������62
Cold Therapy������������������������������������������������������������������������22
Transporting In A Vehicle��������������������������������������������������62
Rapid Contrast Therapy�������������������������������������������������������24
Disposing ����������������������������������������������������������������������������62
EN-iv
Ta b l e o f C o ntent s
Troubleshooting the Med4 Elite Important Messages���������������������������������������������������������� 63 Alarms��������������������������������������������������������������������������������� 64 Error Codes������������������������������������������������������������������������� 68
Repairing the Med4 Elite�������������������������������������������� 68 Med4 Elite Product Specifications���������������������������� 69 Supplied Power Cord Specifications������������������������� 70 UL Classification���������������������������������������������������������� 72 Essential Performance������������������������������������������������ 73 Electromagnetic Compatibility���������������������������������� 73 Accessories and Replacement Parts Accessories������������������������������������������������������������������������� 76 Replacement Parts������������������������������������������������������������� 76
Warranty Manufacturer's Limited Warranty��������������������������������������� 76 How to Obtain Warranty Service������������������������������������ 76 Warranty Registration����������������������������������������������������������77 Warranty of Med4 Elite Accessories�����������������������������������77
Intellectual Property Trademarks, Trade Names, Copyrights and Patents �����������77 Software License�����������������������������������������������������������������77
Symbol Descriptions��������������������������������������������������� 78 Contact Game Ready��������������������������������������������������� 79
Ta b l e o f C o ntent s
EN-v
I N TRODUCT I O N TO T H E M E D 4 E L I T E ™
The advanced technology used in the Med4 Elite allows for treatment of two users simultaneously and utilizes the same anatomically
Based in Concord, California, and founded in 1997, Game Ready ® (CoolSystems®, Inc.) is a best-in-class medical technology company that helps patients and athletes recover from injury or orthopedic surgery. The first Game Ready System was launched in 2002 providing healthcare practitioners with a state-of-the-art medical device that combines cold with active compression. Building upon the breakthrough Game Ready technology, the Med4 Elite is a multi-modality recovery device for professional users. The system
designed Wraps as the Game Ready GRPro ® 2.1 System. The device is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. A list of current patent(s) covering Game Ready technology can be found at: www.gameready.com/patents.
INDICATIONS FOR USE
delivers iceless cold therapy, heat therapy, rapid contrast (alternating
The Med4 Elite™ combines cold, heat, contrast, and compression
heat and cold) therapy, and intermittent pneumatic compression therapy
therapies. It is intended to treat postsurgical and acute injuries to
providing healthcare practitioners with flexible treatment options for
reduce edema, swelling and pain for which cold and compression
different patients, procedures, injuries and stages of rehabilitation.
are indicated. It is intended to treat post traumatic and post surgical
Time-tested principles like RICE (Rest, Ice, Compression, Elevation) and heat therapy are taken to a new level with the use of the state-ofthe-art Med4 Elite System. Cumbersome contrast therapy workflows are improved with the more compact and convenient footprint. Rapid contrast therapy techniques are improved with targeted, body-part specific, dual-action Game Ready Wraps. Heat therapy treatments can be set, monitored and controlled with better accuracy and consistency than traditional methods.
EN-2
Introduction
medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
FEATURES The Med4 Elite offers four therapy options: Heat, Cold, Rapid Contrast and Compression-Only for one or two patients simultaneously. The features and available options that can be customized for each therapy session are shown in the table below.
Four Therapy Options
Temperature Levels
(up to 2 Patients)
Set Minimum and
Heat
Maximum, in °F or °C
Set Minimum and
Cold
Maximum, in °F or °C
Set Heat and Cold Minimum and Maximum,
Rapid Contrast
in °F or °C
-
Compression-Only
Compression Level*
Treatment Time
(Intermittent Pneumatic)
Set total therapy time
Set total therapy time
Low & None
-
Low, Medium-Low,
Snooze function, up to 6
Medium, High & None
cycles
Heat: Low & None
Start Rapid Contrast
Cold: Low, Medium-Low,
Therapy with either Heat
Medium, High & None
or Cold Therapy
Set Heat and Cold Cycle time and total therapy time
Other Features
Low, Medium-Low,
Set total therapy time
-
Medium, High
COMPRESSION LEVELS The Med4 Elite offers four compression levels for Compression-Only and Cold Therapy: Low, Medium-Low, Medium, and High, and one compression level for Heat Therapy: Low. Cold Therapy and Heat Therapy may also be administered with No compression.
No compression
Low
Medium-Low
Medium
High
(None)
(5–15 mmHg)
(5–30 mmHg)
(5–50 mmHg)
(5–75 mmHg)
Introduction
EN-3
ILLUSTRATIONS
On/Off Button
Reservoir Fill Cover
Touch Display Hose Hanger
Handles
Hose Holster Connector Hose
Air Vents
Front Cover
Four (4) Locking Casters
FRONT VIEW
WRAP
(Sold Separately) A Wrap (comprised of an inner ATX® Series Heat Exchanger and an outer Sleeve) must be attached to the Med4 Elite to begin treatment. Each Wrap is sold separately and is not included with the Med4 Elite. Use only Game Ready Wraps with the Med4 Elite. Using products other than those manufactured or provided by Game Ready with the Med4 Elite may void the warranty.
EN-4
Introduction
Fan
On/Off Power Switch
Power Cord Inlet
USB Port Drain Ports
Air Vents
Four (4) Locking Casters
BACK VIEW
INCLUDED HARDWARE AND DOCUMENTATION The following items are included with your system: 1 Med4 Elite Control Unit 1 Power Cord (~8 ft / 2.4 m) 2 Connector Hoses (attached to Control Unit) ATX® Series Heat Exchanger
2 Drain Hoses 1 User Manual
Sleeve
1 Quick Start 1 Quick Reference 1 Game Ready USB flash drive
Introduction
EN-5
DEFINITIONS
Administrator
The person(s) having the authority to determine and set default System Settings for the facility. Those parts of the Graphical User Interface that users press to configure and control functions of
Button
the Med4 Elite operating system.
Active Button
Inactive Button
Control Unit
A graphical button in the GUI that is currently selectable and will perform its intended function and/or purpose upon being pressed. Active buttons appear three dimensional and in full color. A graphical button in the GUI that is currently not selectable. Inactive buttons appear flat and grayed out. The complete Med4 Elite device, including the operating system, internal hardware, cover, connector hoses, etc... The means with which users interact with the Med4 Elite computer.
Graphical User Interface (GUI)
The GUI is composed of icons, buttons, images, and other treatment information. Users press buttons to configure therapy sessions and System Settings and to control therapy sessions. Once started, the GUI displays the progress of active therapy sessions. Med4 Elite GUI symbols that represent Med4 Elite patients, therapy modality levels, internal
Icon
conditions and alarms.
On/Off Button
The button located at the top of the touch screen that powers the computer up and powers it down.
On/Off Switch
The toggle switch on the back of the Control Unit that supplies power to the system.
Patient
The person receiving therapy via the Med4 Elite.
Personal Identification Number (PIN)
The numeric password that allows the administrator to access Med4 Elite System Settings.
Reservoir
One of two receptacles inside the Control Unit that store, heat, and cool the water.
Reset
To return the Med4 Elite computer to factory settings. The automated action that occurs after a user makes changes to System Settings: the Med4 Elite
Restart
computer powers down and when turned on again, will operate with the new settings. A Med4 Elite computer interface where users set Control Unit functions and monitor Control Unit
Screen
activity. For example, the Select Patient screen.
Session
A single treatment.
Snooze
The amount of time in which no treatment is provided during Cold Therapy.
System
Refers to the entire Med4 Elite Control Unit.
System Shut Down
Powering down the Med4 Elite computer and turning the On/Off switch off. The glass panel that displays the Med4 Elite Graphical User Interface and with which Med4 Elite
Touch Screen
users physically interact with the Control Unit’s computer by touching buttons that are displayed onscreen. The person operating the Med4 Elite.
User
EN-6
Introduction
SAFETY
IMPORTANT: READ COMPLETE INDICATIONS, CONTRAINDICATIONS, CAUTIONS AND WARNINGS BEFORE USING THIS PRODUCT Caution: United States Federal Law restricts this device to
WARNING: It is mandatory to fully read and understand the User Manual before using the device. Failure to follow operating instructions could result in serious injury.
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
ATTENTION: Consult User Manual.
device. A licensed health care professional should set up and supervise the use of this device for the patient.
MED4 ELITE CONTRAINDICATIONS THERAPY MODE X = Absolute Contraindication – Thermotherapy
Cryotherapy
Compression
Rapid Contrast
Therapy in these situations should not be used in patients who have:
Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, systemic venous hypertension, congestive heart failure, cirrhosis/liver failure, renal failure).
X
X
X
X
Significant vascular impairment in the affected region (e.g., from prior frostbite, arteriosclerosis, arterial insufficiency, diabetes, vascular dysregulation, or other vascular ischemic disease).
X
X
X
X
X
R
X
R = Relative Contraindication – Therapy for these conditions should be used only under the supervision of a licensed healthcare practitioner in patients who have:
Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sickle-cell disease, serum cold agglutinins). Tissues inflamed as result of recent injury or exacerbation of chronic inflammatory condition.
X
R
X
Extremities with diffuse or focal impaired sensitivity to pain or temperature that prevent the patient from giving accurate and timely feedback.
X
R
X
Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures) in the affected region.
R
R
Cognition or communication impairments that prevent them from giving accurate and timely feedback.
X
R
An acute, unstable (untreated) fracture in the affected region.
X
R
X
Local malignancy.
X
R
X
Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound, scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Med4 Elite.
X
R
X
Actively bleeding tissue or hemorrhagic conditions.
X
X
Recently radiated tissues or areas affected by heat-sensitive skin diseases (e.g., eczema, psoriasis, vasculitis, dermatitis).
X
X
Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
R
Any active local or systemic infection.
X
Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis.
R
R
R
X
S a f e t y a n d C o n t r a i n d i c at i o ns
R
R X
R
R
X
X
X
X
EN-7
THERAPY MODE X = Absolute Contraindication –
X
A pregnancy.
Rapid Contrast
Therapy for these conditions should be used only under the supervision of a licensed healthcare practitioner in patients who have:
Compression
R = Relative Contraindication –
Cryotherapy
Thermotherapy
Therapy in these situations should not be used in patients who have:
X
Any significant risk factors or current clinical signs of embolism (e.g. pulmonary embolus, pulmonary edema, cerebral infraction, atrial fibrillation, endocarditis, myocardial infarction, or artheromatous embolic plaque).
X
X
X
A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity).
X
X
X
Raynaud’s disease or cold hypersensitivity (cold urticaria).
X
X
Hypertension, Cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
R
R
X
R
Children under 18 years old
R
R
R
R
R
R
R
R
X
R
Had recent toe surgery in the affected region.
Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis.
Decompensated hypertonia in the affected region.
IMPORTANT: Refer to the most up-to-date Wrap Use Guide for Wrap specific contraindications and warnings, which can be found at www.gameready.com
GENERAL WARNINGS AND CAUTIONS • (General) Follow the treatment recommendations of your health care practitioner for duration and frequency of use for this device. • (General) Improper placement or prolonged use of the Med4 Elite could result in tissue damage. • (General) The Med4 Elite is not for use in a sterile environment. • (General) 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.
R
X
X
frequently and use mid-to-higher (warmer) temperature range settings or leave more time between treatments, if necessary. • (General) 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 excessive redness, blistering, signs of burning, light-headedness, generalized sweating (increased core temperature), 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. • Monitor the level of heat throughout treatment session. Caution should be used with the Med4 Elite System or any thermotherapy (Heat Therapy) device generating high intensity heat at 113°F or above. Check the skin of the treated region frequently and use mid-to-lower (cooler) temperature range settings or leave more time between treatments, if necessary. • Device not intended for use with numbing agents.
• (General) A layer of clothing between Wrap and skin is recommended for all patients. • (General) 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. • (General) 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
EN-8
S a f e t y a n d C o n t r a i n d i c at i o ns
• Heating of the gonads and developing fetus should be avoided. • When using heat and rapid contrast therapy, skin should be protected in heat- sensitive or high-risk patients, especially over regions with sensory deficits. • All Cryotherapy and Thermotherapy warnings and cautions also apply to Rapid Contrast Therapy. • Compression Therapy in combination with Heat Therapy should only be used at a level that provides better (or firm) contact with the skin, but does not compress the tissues.
• WARNING: Use Carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the Med4 Elite by children or incapacitated persons may be dangerous.
Measured Skin Temperatures
Maximum Temperature
Skin temperature measured as high as 111 °F (44 °C) when set to maximum Heat Reservoir set point
Minimum Temperature
Skin temperature measured as low as 44 °F (7 °C) when set to minimum Cold Reservoir set point
SYSTEM WARNINGS AND CAUTIONS • To avoid the risk of electrical shock, do not remove any panels from the Control Unit. Opening the Control Unit will void the Med4 Elite warranty. For all servicing and repair, in the U.S. call Game Ready Technical Support at 1.888.426.3732 (+1.510.868.2100); from outside of the U.S. please contact your local distributor.
• Device contains R-134a refrigerant, to be serviced by qualified technicians only. • The cooling system in your Med4 Elite contains R-134a, a refrigerant covered by the United States Environmental Protection Agency’s (EPA) disposal regulations and potentially other international environmental agencies. To avoid confusion and potential environmental damage, contact your local waste facility and inquire about disposal procedures for the Med4 Elite. • WARNING: To safely interact with the Med4 Elite touch screen, you must be standing within 1 foot (30 cm) directly in front of the device. • Use only Game Ready supplied Power Cord. See Supplied Power Cord Specifications for details. • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. •
This symbol on the Control Unit or its packaging means that this product must not be disposed of with household/consumer 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.
•
In order to prevent trip hazards, the connector hose(s) must be properly placed in the holster(s) when not in use. Wrap the Hose once around the Hose hanger and place the end into the holster as shown. Ensure the numbered Hose Connector corresponds with the number on the Hose hanger.
• 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. • WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • WARNING: No modification of this equipment is allowed. Any modification, or attempt at modification, could be hazardous and will void the Med4 Elite warranty. • Do not tip the Med4 Elite on its side. • To avoid potential damage to the Med4 Elite, do not use other manufacturers’ wraps with the Control Unit. • To avoid injury, be careful not to trip over the Control Unit’s power cords and Connector Hoses.
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,
• Keep the Med4 Elite, including hoses and cords, away from children and pets.
birth defects or other reproductive harm.
• Use caution when handling small parts to reduce any possibility of swallowing or inhalation. • The Med4 Elite Control Unit is a 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. Such abuse will void the Med4 Elite warranty. • Use only distilled water to fill device. • Perform routine cleaning and water disinfection per instructions. • Fill reservoirs with distilled water per instructions before supplying power to the device.
S a f e t y a n d C o n t r a i n d i c at i o ns
EN-9
G E TTI N G S TART E D
FILLING THE RESERVOIRS The Med4 Elite ships with the reservoirs empty. You will need to fill the reservoirs prior to use. Two gallons (eight liters) of distilled water are
SETTING UP
needed to completely fill the reservoirs.
The Med4 Elite arrives with a Quick Start located in the Accessory Kit box. Please read the instructions carefully before powering up and
IMPORTANT: Use distilled water only. DO NOT use deionized
operating the device.
water or tap water. Failure to use distilled water may void the warranty of the device.
Use the handles to move the Control Unit into place. The Control Unit should be set up: • within six feet of a power outlet with a dedicated electrical circuit or enough power to supply 1200 watts • with adequate access to the On/Off Switch on the back of the unit and with the power cord unobstructed • on level ground within the facility
1.
The reservoir opening is located below the touchscreen on the Control Unit. Open by pressing on the cover to release the latch and lift.
2.
Carefully pour distilled water into the reservoir opening.
3.
When finished filling the reservoirs, close the cover. Press
• indoors only
firmly to engage the latch.
• in a dry location • so that vents on all sides are unobstructed • free of trip hazards
IMPORTANT: The Med4 Elite should never be tipped on its side. Tipping of the control unit may cause damage to the compressor and may void the warranty.
Once the device is located in a suitable location, lock the casters in place by pressing down on all four caster locks until they click into the down and locked position.
POWERING UP Connections and Powering Up 1.
Attach the supplied power cord to the back of the Control Unit.
2.
Plug the power cord into the appropriate power outlet.
IMPORTANT: Place the power cord in a safe location to prevent tripping hazards or inadvertent disconnection.
3.
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G e t t i ng S ta r t e d
Turn on the power switch located on the back of the Control Unit.
SETTING THE LANGUAGE The first task you will be asked to complete with your Med4 Elite is to select and confirm a Language for the user interface. On the initial boot, the Select Language screen appears.
After you switch the power on, the On/Off button at the top of the touch screen illuminates in amber.
1.
Press the up or down arrows to scroll through the available languages.
2.
To select the default language setting, press the Confirm button.
The Confirm Language screen appears.
4.
Press the On/Off button to turn on the Med4 Elite. The On/Off button at the top of the touch screen will turn green.
3.
To confirm the default language setting, press the Confirm button.
4.
Restart to Apply Settings by pressing the
Confirm
button a second time. The Control Unit's computer powers down. 5.
Press the On/Off button located at the top of the touch screen to restart the computer.
The Med4 Elite operating system takes up to 60 seconds to load.
G e t t i ng S ta r t e d
EN-11
Upon powering the Control Unit back on, the Select Patient screen will appear. The Med4 Elite is now ready for use. Select a patient to begin setting up a therapy. See Using the Med4 Elite for further instruction.
CHANGING FACTORY SETTINGS The Med4 Elite ships with factory settings that define the default settings for therapy sessions. Settings include minimum, maximum and default heat and cold temperatures; minimum, maximum and default compression, minimum, maximum and default therapy session times, reservoir temperatures, interface language, and temperature scale. These settings determine the allowable temperature and compression ranges for therapy sessions, as well as the default settings you see when you start up the Control Unit. You can use the Med4 Elite with factory settings, or you can change these settings to meet the requirements of your facility at any time. To view the factory settings and the procedures to change the settings, refer to Configuring Med4 Elite System Settings.
IMPORTANT: If the Control Unit detects an insufficient amount of water in the reservoirs, you will not be allowed to continue until adding an adequate amount of water.
PERSONAL IDENTIFICATION NUMBER (PIN) The Med4 Elite is delivered with a factory default PIN. The factory default PIN is 1111. The PIN is necessary to access System Settings and to change default settings. You may change the PIN number in System Settings, refer to Configuring Med4 Elite System Settings. Please remember to keep your PIN secure and accessible.
IMPORTANT: If you lose or forget your PIN, call Game Ready Technical Support and request a Master PIN. This will allow you to access the System Settings to configure a new PIN. You can contact Game Ready Technical Support at 1.888.426.3732 (1.888.GameReady) and +1.510.868.2100. From outside the U.S., contact your local distributor.
It is important that you fill the reservoirs prior to turning on the Med4 Elite. If it is turned on without water, or with an insufficient amount of water, you will be prompted to add water before continuing. See Filling the Reservoirs for instruction. Once both reservoir levels reach at least 75%, the Select Patient screen will automatically appear, and the Med4 Elite is now ready for use.
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G e t t i ng S ta r t e d
M E D 4 E LIT E AT A G LA N C E
A
USER INTERFACE ELEMENTS A. Screen Title B. Access System Settings
G
D
C. Toggle Temperature Scale between °F and °C
H
D. Selected Patient
F
E
E. Available Therapies F. Switch Patient
I
G. Target Reservoir Temperature H. Decrease or Increase Target Temperature
C
B
J. Type of Therapy in Progress K. Total Time Remaining
I.
N
J
P
L. Stop Therapy M. Pause Therapy N. Compression Level
Actual Reservoir Temperature
K
O
O. Add Patient
Q
P. Actual Heat Reservoir Temperature Q. Actual Cold Reservoir Temperature
L
PATIENT OPTIONS
M
TITLES / SETTINGS
RESERVOIR OPTIONS
G r a p h i c a l U s e r In t e r fac e
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THERAPY ICONS The User Interface uses icons to control the Med4 Elite. Icon
Name Access System Settings Toggle between Fahrenheit (°F) and Celsius (°C) Heat Reservoir Level and Current Reservoir Temperature Cold Reservoir Level and Current Reservoir Temperature
Name Snooze Total Number of Cycles
Snooze Cycle Status
Heat Therapy
Adjust Heat Therapy Settings
Increase setting
Rapid Contrast Therapy
Decrease setting
Adjust Rapid Contrast Therapy Settings
Start Therapy
Set Beginning Therapy
Cancel
Rapid Contrast Therapy Heat Time
Pause Therapy
Rapid Contrast Therapy Cold Time
Stop Therapy
Rapid Contrast Therapy Total Time
Patient 1 Add
Compression-Only Therapy
Patient 1 Select
Adjust Compression-Only Therapy Settings
Patient 1 Switch
No compression (None)
Patient 2 Add
Low compression (5–15 mmHg)
Patient 2 Select
Medium-Low compression (5–30 mmHg)
Patient 2 Switch
Medium compression (5–50 mmHg)
Cold Therapy
High compression (5–75 mmHg)
Adjust Cold Therapy Settings
General Alarm
Toggle Snooze On
Attention: Consult User Manual
Toggle Snooze Off
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Icon
G r a p h i c a l U s e r In t e r fac e
SYSTEM SETTINGS ICONS The System Settings User Interface uses icons to control the default settings of the Med4 Elite. Icon
Name
Icon
Name
Access System Settings
Compression-Only Therapy Settings
Change Personal Identification Number (PIN)
Compression-Only Therapy Time Settings
Factory Reset
Cancel
Language Settings
Confirm
System Information
Return
Data Download
Start
Software Update
Exit to Save Settings (Restart Required)
Cold Therapy Settings
No compression (None)
Cold Therapy Time Settings
Low compression (5–15 mmHg)
Cold Therapy Compression Settings
Medium-Low compression (5–30 mmHg)
Cold Reservoir Temperature Settings
Medium compression (5–50 mmHg)
Snooze Settings
High compression (5–75 mmHg)
Enable Snooze
Disable Snooze
Heat Therapy Settings
Heat Therapy Time Settings
Heat Therapy Compression Settings
Heat Reservoir Temperature Settings
Rapid Contrast Therapy Settings
Rapid Contrast Time Settings
G r a p h i c a l U s e r In t e r fac e
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U SI N G TH E M E D 4 E LIT E
3.
Resume therapy for the first patient by pressing the Start button.
4.
Set up the second patient and press the Start button.
SETTING THE TEMPERATURE SCALE (°F / °C) The Med4 Elite enables you to view temperatures in either Fahrenheit (°F) or Celsius (°C). From any screen you can quickly switch between the two. For example, to set the temperature scale from the Select Patient screen:
SETTING THE TEMPERATURE • The Med4 Elite has two water reservoirs that are used to achieve the desired therapy temperature. One is used for Heat Therapy and one is used for Cold Therapy. Reservoir temperatures can be set from the Select Patient screen shown above. • It is recommended that reservoir temperatures are set for the most common therapy temperatures at the start of the work day. • Or the reservoir temperatures can be set in the Administrative Settings to default temperatures when the Med4 Elite is turned on. • If a therapy requires a change from the set reservoir temperature, the new reservoir temperature can be selected from the Select Patient screen prior to setting up the patient therapy. This allows the reservoirs time to reach desired temperatures prior to treatment.
1.
Press the temperature scale icon in the lower right corner of the screen.
The temperature scale switches. In this example, the scale switches from Fahrenheit to Celsius.
NOTE: See Safety > General Warnings and Cautions for expected maximum and minimum skin temperatures.
ADJUSTING RESERVOIR TEMPERATURE WHEN SHARED BETWEEN TWO PATIENTS The Med4 Elite reservoirs are shared between patients. When two patients are being treated with therapies that use the same reservoir, the therapy temperature will be the same for both patients.
SETTING UP THERAPY SESSIONS
When setting up a therapy for the second patient that uses the same
The Med4 Elite allows you to set up individual therapy sessions for up
reservoir as the first patient, the therapy temperature selection (+ or -)
to two patients at a time. Therapy modalities include:
buttons will be inactive. The reservoir temperature will remain at the temperature set for the first patient. If a different temperature is desired, all therapies must first be paused in order to adjust the reservoir
• Heat Therapy (Thermotherapy) with or without compression • Cold Therapy (Cryotherapy) with or without compression
temperature. Attempting to change the temperature while a therapy is in progress will display the Heat/Cold Reservoir in Use message.
• Rapid Contrast Therapy (rapidly alternates between Heat and Cold therapies) with or without compression
To change the reservoir temperature: 1.
Pause treatment on the first patient, and adjust the temperature.
2.
This adjusted temperature will be the same for both patients.
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Using the Med4 Elite
• Compression-Only Therapy (no water flow) You can pause, stop or change therapies at any time during treatment.