User Guide and Operating Manual

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Deep Penetrating Infrared Light Therapy Panel System User Guide and Operating Manual Roscoe Medical, Inc. 21973 Commerce Parkway Strongsville, Ohio 44149 1.16.13 INCLUDES IMPORTANT SAFETY INFORMATION READ ALL INSTRUCTIONS BEFORE USING THE DEVICE SAVE THESE INSTRUCTIONS

Index Personal Notes Item Page Product Description 2 Indication for Use 2 Warnings 3 Cautions 4 Assembly Instructions 5 Cleaning Instructions 7 Instructions for Temporary Relief of Pain 8 Frequently Asked Questions 10 Disclaimer 12 Warning Symbols 12 Warranty 12 Personal Notes 13 _ 1 14

Personal Notes PRODUCT DESCRIPTION The NuVita Infrared Light Therapy System is a compact infrared lamp for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The lamps are contained in two separate panels on a desk stand. The panels are detachable for use individually or as a pair on the body. A Velcro strap is used to hold the panels to the body. The product has an automatic 17-minute timed cycle which may be repeated by activating the ON button. There are no user settings or adjustments. INDICATIONS FOR USE The NuVita Infrared Light Panel Therapy System is intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation. 13 2

WARNINGS 1. The NuVita Infrared Light Therapy System is an electrical device. To avoid electrical shock: a. Do not wash unit with water. b. Do not touch the plug or device with wet hands. c. Do not touch unit to wet skin. d. Do not use if cord or plug appears to be damaged. e. Do not use the unit if it has been dropped, damaged, left outdoors, or dropped into water. f. Do not pull, lift, or carry unit by the power cord. g. Do not use the cord as a handle, close a door on the cord, or pull the cord against sharp edges or corners. h. Do not use near heated surfaces. Velcro strap or the supplied stand. 4. Do not allow children to use this is not a toy. Do not leave small children unattended close to unit. 5. Not to be used by disabled, sleeping or unconscious persons. 6. Do not use the unit on an open wound, as heat may increase circulation and cause bleeding. 7. Do not use over thyroid gland (the neck area) if the user has been diagnosed with or suspects thyroid problems. No clinical data is available to support use for patients with thyroid gland problems. 8. Do not use with liniments, salves or ointments that contain heatproducing ingredients as a skin burn could result. 9. There are no user-serviceable parts inside the unit. Any attempt to open the unit will void the warranty and could lead to serious damage to the unit and/or personal injury to the operator. DISCLAIMER This product is not intended to diagnose, cure or prevent disease. Roscoe Medical makes no claims, representations or warranties regarding the ability of this product to cure health professional should be consulted with regard to any condition requiring medical attention. Attention - Consult Accompanying Documents Standby/On EQUIPMENT CLASSIFICATION WARNING SYMBOLS The operator must read, understand, and follow all instructions in the accompanying documents including all warnings, cautions, and precautions before using the medical device. This symbol indicates that the patient ap- This symbol indicates that the switch electronically cycles the DC power On and Off for part of the equipment. Note: To disconnect the power, unplug from electrical outlet. WARRANTY Roscoe Medical warrants that your product (NuVita Infrared Light Therapy System) will be free from defects in materials and workmanship for one year from the date of purchase by the original owner. This warranty covers the original purchaser only and is not assignable or transferable to another party. 3 12

FREQUENTLY ASKED QUESTIONS Question: Why can t I see some of the lights? They are all on. The LEDs that you cannot see are in the Infra-Red (IR) spectrum, which is not visible light to the human eye. Question: I have arthritis in my hands. Will I be able to use the system? The NuVita Infrared Light Therapy System is designed with the arthritis sufferer in mind and can easily be used on the stand for your hands for the temporary relief of pain. The device is also lightweight and easy to hold. Question: Why do I hear beeps? The system is made to beep every minute for seventeen minutes and then shut off, giving you an idea of how long you have been using the system. Question: I have used my system for a couple of days. Why am I still hurting? Keep in mind that this system is for temporary relief of pain for minor muscle, joint and arthritic discomfort; it is not a miracle drug or pain killer. The system is not intended to replace any current medication prescribed by your This may be a symptom of other conditions needing immediate attention. Question: Why doesn t the system get hot? Some people report that their system gets warm or they feel warmth in their skin, which is normal. The system is designed to emit a comfortable heat range of temperature. 1. Consult your doctor prior to using, especially if you: a. are pregnant, b. are taking drugs known to cause sensitivity of skin to light, c. have any suspicious or cancerous lesions,and/or d. recently had a steroid injection or use topical steroids. 2. Individuals using aspirin, ibuprofen and other similar drugs for pain or a symptoms and should stop using the NuVita Infrared Light Therapy System. 3. Read all instructions and safety precautions before using the NuVita Infrared Light Therapy System. 4. Do not use on infants. 5. If you experience discomfort or have a concern about its use, stop use immediately and contact your doctor. 6. Use indoors only. CAUTIONS 7. Use only the supplied power supply. 8. Turn off all controls before unplugging unit from the outlet. Unplug from outlet when not in use to void tripping hazards. 9. Do not unplug by pulling the cord. Grasp the plug itself, not the cord, when unplugging from an outlet. Question: Does it work through clothes? No. Question: Will it hurt my eyes? There are no studies showing any harmful effects to the eyes when using the system. Protective eye wear in not required. 11 4

ASSEMBLY INSTRUCTIONS 1. Unpack your NuVita Infrared Light Therapy System. Your box will include the following: 1. NuVita Infrared Light Panels (2 panels) 4. Panel Connector Wire 2. NuVita Infrared Light Stand (3 pieces) 5. Velcro Strap 3. Power Supply and Cords 6. User Guide and Operating Manual FREQUENTLY ASKED QUESTIONS Question: What will I notice during and after treatment? 1. You will feel an increase in warmth in the treated area(s). 2. Different sensations are possible with use of the system depending on the individual: 1. NuVita Infrared Light Panels (2 panels) 3. Power Supply & Cords Question: When will I feel better or see some positive results? You may feel better or experience positive results immediately. Other individuals may have to treat themselves over several days or weeks before noticing results. It is important to remember that we are all unique; various physical conditions can affect results. 2. NuVita Infrared Light Stand (3 pieces) Mounting Bracket 4. Panel Connector Wire 5. Velcro Strap Question: How often can I use the NuVita Infrared Light Therapy System? We recommend 2 (17 minutes each) treatments per day. Question: How does the NuVita Infrared Light Therapy System help with my everyday aches and pains? The NuVita Infrared Light Therapy System can be used for temporary relief of pain by emitting energy in the Near-IR spectrum. It is intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation. Column 6. Operating Manual Question: How close to the skin should I hold the NuVita ILT Panel? For best results the panel should be as close to the skin as possible but Center the panels on the main area of treatment for maximum effectiveness. Base 5 10

INSTRUCTIONS FOR TEMPORARY RELIEF OF PAIN ASSEMBLY INSTRUCTIONS (CONTINUED) Dual Panel Use With Stand: 1. Place both panels on stand. 2. Attach Panel Connector Wire between panels. 2. Assemble Stand (3 pieces). 3. Attach Power Supply to Panel. 4. Plug Power Supply into electrical outlet. 6. Place body part ( hands, arm, from LED panels. You will hear a beep and the lights will come on. You can only see the red LEDs; the others are in the infrared spectrum and can t be seen with the human eye. The unit will beep in one minute intervals for a total of seventeen minutes. 7. The unit will automatically turn off at the end of the 17 minute treatment cycle. Device takes 8 minutes to reach target temperature on skin. Total time for treatment is 17 minutes. Column (1) 3. Attach NuVita Infrared Light Panels to stand. The panels are different. The Master panel (A) has 2 plugs and a switch along the bottom edge. Align tabs and slide Master panel (A) onto right side of Mounting 8. To quit before treatment is over, Right Panel Master (A) Recommended Usage: We recommend 2 (17 minutes each) treatments per day. 9 6

4. Attach Panel Connector Wire between Panels. INSTRUCTIONS FOR TEMPORARY RELIEF OF PAIN 7 Panel Connector Wire 5. Attach Power Supply to Panel. Power Supply 6. Plug Power Supply into electrical outlet. 8. Device will automatically turn off in 17 minutes. TECHNICAL SPECIFICATIONS Power button (On/Off) Infrared Light Therapy System is NOT user serviceable. CLEANING INSTRUCTIONS Allow system to cool before applying rubbing alcohol. Dual Panel Use With Strap: 1. Remove both panels from stand and place or wrap around desired area. 2. Slip Velcro strap through openings on back of panel and fasten around body. 3. Press Power button and release. You will hear a beep and the lights will come on. You can only see the red LEDs; the others are in the infrared spectrum and can t be seen with the human eye. The unit will beep in one minute intervals for a total of seventeen minutes. 4. The unit will automatically turn off at the end of the 17 minute treatment cycle. Device takes 8 minutes to reach target temperature on skin. Total time for treatment is 17 minutes. 5. To quit before treatment is over, push Single Panel Use With Strap: 1. Unplug Panel Connector Wire from Master panel. 2. Slip Velcro strap through openings on back of the Master panel and fasten on desired area. 3. Press Power button and release. 4. The unit will automatically turn off at the end of the 17 minute treatment cycle. Device takes 8 minutes to reach target temperature on skin. Total time for treatment is 17 minutes. 5. To quit before treatment is over, push Recommended Usage: We recommend 2 (17 minutes each) treatments per day. 8