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Summary of Contents for Anodyne Therapy 120
- Page 1 Anodyne Therapy ® Consumer System Model 120 Important Safety Information and Instructions Read Entire Booklet Before Operating...
- Page 2 Anodyne® Therapy Systems received clearance from the US FDA in 1994 and are compliant to the ISO 13485 Inter- national Standard. Review this manual in its entirety prior to using this system and contact Anodyne Therapy, LLC at 1-800-521-6664 with any questions, comments or concerns.
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Page 3: Table Of Contents
TABLE OF CONTENTS Summary ....................4-5 General Warnings and Precautions............ 6-8 Purpose of Device (Indications for Use) ..........8 Device and Parts Description ..............9 Environmental Conditions Affecting Use ........... 9 Instructions for Use ................10-12 Treatment Guidelines ................ 13-16 Cleaning ......................17 Maintenance ....................18 Storage ......................18... -
Page 4: Summary
SUMMARY This summary is not intended to replace the complete user instructions. The entire manual should be read and understood before operating the Model 120. Warning and Cautions This device emits heat and may cause burns. Risk of burns is reduced in the following ways: •... - Page 5 SUMMARY Basic Operating Instructions: Components: Image of the Model 120 components are shown on page 9. Set Up: Place the Control Unit on the floor next to you. Plug the Therapy Pad cords into the Connectors on the front of the Control Unit.
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Page 6: General Warnings And Precautions
CONTRAINDICATIONS The Anodyne® Therapy System, Model 120 should not be used directly over or near the womb during pregnancy or directly over an active cancer lesion. The use of this device with these types of conditions are unknown. GENERAL WARNINGS AND PRECAUTIONS WARNING: Use carefully. - Page 7 • Do not use a portable electric generator as a power source as this may damage the electrical components of your device. • The Anodyne® Therapy System, Model 120 is an electronic device in which a portion of the electronics may be hazardous. As such, the device should be disposed of in an environmentally responsible manner.
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Page 8: Purpose Of Device (Indications For Use)
• Discontinue use if device materials cause skin irritation. PURPOSE OF THE DEVICE (INDICATIONS FOR USE) • The purpose of the Anodyne® Model 120 is for the temporary relief of pain, stiffness and muscle spasm and for temporarily increasing blood circulation. -
Page 9: Device And Parts Description
COMPONENTS The Anodyne® Therapy System, Model 120 consists of the Main Control Unit, Therapy Pads, Attachment Straps, Velcro Strips, and an optional Lower Extremity Treatment System. Also included is a carrying case, which is not pictured. Foot Leg Attachment Attachment... -
Page 10: Instructions For Use
SETTING UP YOUR SYSTEM Warning: If electrical wires are exposed, discontinue system use and call Anodyne Therapy, LLC at 1-800-521-6664 to arrange for service. Exposed wires may be unsafe and cause electrical shock. Step 1: Remove the device from the packaging and protective plastic bag. - Page 11 DO NOT STAND OR WALK ON THE FOOT STRAP. Step 5: Turn on your Model 120 by depressing the ON/OFF switch and begin your treatment following the times listed in the Instructions for Use on pages 12...
- Page 12 Step 2: Remove the Foot Strap by sliding your foot out of the Foot Strap. Step 3: Remove the Leg Attachment Strap by loosening the Velcro attachment. Step 4: Store the Anodyne Model 120 in a safe, dry and cool place away from children and pets until the next use.
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Page 13: Treatment Guidelines
TREATMENT GUIDELINES • Be sure you review all the Warnings and Precautions before using this system to prevent burns or electrical shocks. • You may treat an area up to three times per day, separated by at least four hours between treatments. •... - Page 14 TREATMENT GUIDELINES To temporarily increase circulation, decrease pain or muscle spams in the extremities Feet and Legs: - Place two Therapy Pads in the form of a “T” inside the Foot Strap. - Place one pad on each side of calf approximately where Pads should be placed symptoms begin using the inside the Foot Strap like...
- Page 15 TREATMENT GUIDELINES To temporarily relieve pain, muscle spasm or stiffness Place a minimum of two Therapy Pads directly over the painful area (i.e., knee, elbow, neck, back, etc.) If placement of Therapy Pads causes increased Therapy Pad pain, place pads right next (lateral) to the injured Placement site.
- Page 16 PAD PLACEMENT EXAMPLES The Therapy Pads can be arranged to fit any area of the body where the user is experiencing pain or would benefit from increased circulation. If there is an open wound in the treatment area, or if this system is being shared by more than one user;...
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Page 17: Cleaning
1. Cleaning is necessary only if the Therapy Pads become excessively soiled. 2. Unplug the Model 120 from the electrical outlet. 3. Lightly spray a clean cloth with a common household disinfectant spray and wipe the cloth over the entire surface of the Therapy Pads. -
Page 18: Maintenance
Unit and unplug the Power Supply from the electric outlet. STORAGE When not in use, store your Model 120 in a cool, dry area away from access by either children or pets. Storage in a wet or excessively damp location may cause corrosion of electrical components or wiring that may result in electrical shock or impair the proper function of the device. -
Page 19: Troubleshooting
Control Unit or • Have a friend or family member confirm Therapy Pads heat. get too hot • If problem persists, discontinue system use and call Anodyne Therapy, LLC at 1-800-521-6664 to arrange for service. -
Page 20: Declarations
DECLARATION - ELECTROMAGNETIC EMISSIONS The Anodyne® Therapy System, Model 120, is intended for use in the electromagnetic environment specified below. The user of this product should assure that it is used in such an environment. Electromagnetic Environment - Emissions Test... - Page 21 DECLARATION - ELECTROMAGNETIC IMMUNITY The Anodyne® Therapy System, Model 120, is intended for use in the electromagnetic environment specified below. The user of this product should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 Test...
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Page 22: Warranty And Return Policy
RETURNING A UNIT FOR REPAIR To send a unit to Anodyne Therapy, LLC for repair, you must first call 1-800-521-6664 and obtain a return authorization (RA). The following information must be supplied to Anodyne Therapy, LLC before an RA number can be issued: 1. -
Page 23: Index
INDEX Cleaning, 17 Contraindications, 6 Control Unit, 4-5, 9-10, 12, 18-19 Customer Service, 2, 6, 10, 13, 19 Device Disposal, 7 Pain Patches, 4, 6 Return Policy, 22 Single Use, 8 Straps, 9, 11-13, 16-17 Therapy Pad Placement, 5, 6, 8, 11-17 Therapy Pad Pressure, 4-6, 11-15 Topical Agents, 4, 6 Troubleshooting, 19... - Page 24 Oldsmar, FL 34677 Tel: 1-800-521-6664 Fax: 1-800-835-4581 Website: www.anodynetherapy.com ® Anodyne Therapy and MIRE are registered trademarks of Anodyne Therapy, LLC. US Patent No. 5,358,503 © 2021 Anodyne Therapy, LLC All Rights Reserved MR-03800 Rev. X – January 12, 2021...
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Questions and answers
I have a patient who has recently had a pacemaker has a donor kidney and significant swelling and pain in his feet. I was wondering is there any contraindications to using for light therapy on a patient with these conditions and he is also diabetic I have anodyne to treat patients in home. patient is complaining of 10 out of 10 pain and unable to stand or walk and participate with physical therapy. Even the seated exercises are hurting too much to do and I want to make sure there is no contraindications of using this modality on a patient With these diagnoses
The contraindications listed for the Anodyne® Therapy System, Model 120, specify that it should not be used directly over or near the womb during pregnancy or over an active cancer lesion. There is no mention of contraindications related to pacemakers, donor kidneys, significant swelling and pain in the feet, or diabetes. However, the general warnings indicate that the device should not be used over sensitive areas or in the presence of poor circulation, which may be relevant depending on the patient's condition. Consulting a healthcare provider is recommended before use.
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