Medlight 630 Pro Near Infrared Light Therapy Device User Manual
Contents
1. MedicalDEVICES IMPROVING YOUR QUALITY OF LIFE Rte ELLID T F ececcccece F eeeccccosoce a cosccocoeose I eoccccssesce Seeceececeeo D seeceeese f A Pr ENLLI ITI ae i z247 nep trga es 630PRO Pain Therapy Device Instructions for Use Effective Pain Therapy for the Temporary Relief from Minor Pain To ensure the best results and long term satisfaction with your Medlight 630PRO we recommend that you read the following instructions carefully before use 2010 Medical Devices Inc Medlight 630PRO Operating Instructions and User s Guide Rev 5 1 May 13 2010 P N 1075 0042 MADE IN THE USA Intended Use Medlight 630PRO Pain Therapy Device is a hand held device used for the treatment of chronic pain emitting energy in the Near IR spectrum for the temporary relief of minor muscle and joint pain arthritis and muscle spasm relieving stiffness promoting relaxation of muscle tissue and to temporarily increase local blood circulation Contraindications There are no known contraindications for the use of the Medlight 630PRO Warnings e Keep the Medlight 630PRO out of reach of young children who are not able to read and understand the Warnings and Cautions listed below e Do not allow device to come in contact with water contact with water may cause electric shock 8 Do not use other Power Supplies or Car Adaptors with device Using other products may cause electrical shoc2. lights 1cm depth of lip on Medlight 630PRO device from the skin Prior to the start of the test subjects skin temperature ranged from 94 F to 97 F FDA requires devices that use thermal energy to provide pain relief must demonstrate the ability to generate temperatures of 40 42 C 1 04 107 6 F at the treatment site for a duration of 5 10 minutes Maintenance Clean the surface of the lens and body with a damp cloth only Do not use any type of solvent or other cleanser To protect the Medlight 630PRO mechanism store at room temperature in a dry place out of the reach of children and in the original packaging when not in use The MEDLIGHT contains no user serviceable parts Do not disassemble Problem Solution No red light emitted from the light source WAIT light is illuminated Device Wait until WAIT light goes off Overheating before resuming treatment Check to make sure the power supply is securely plugged into the MedLight 630 No red light emitted from No Power to Pro light source device Check to make sure the power supply is securely plugged into the wall outlet International Use The POWER SUPPLY included with the MEDLIGHT 630PRO is universal input 100 240 VAC 50 60 Hz and can be used anywhere in the world User needs to supply appropriate plug in adaptor O Product Life Cycle MEDLIGHT 630PRO product life cycle 100 000 treatment cycles End of device life cycle will be demonst
3. ic benefit In general Medical Devices Inc recommends two to three sessions spaced throughout the day However treatment may be repeated as often as needed Usage Tips For minor muscle pain and or spasm e Identify the location of pain and apply the device directly to area For joint pain and arthritis FRONT VIEW e Apply the device to the joint line Joint Line area where the two bones meet 7 Fig 1 A For hard to reach areas if Treated e A Flexible Velcro Holding Strap is included with the Medlight 630PRO to provide hands free operation during treatment Insert the device into the loop of the strap being careful not to SIDE VIEW cover fan vents Fig 2 and 3 Area Hold the LED light source over the treatment area and fasten the Velcro holding strap to comfortably and securely hold the device in place Fig 2 Fig 3 Operating Instructions Refer to page 3 b for illustrations 1 Plug the power supply into the Medlight 630PRO power supply connection and then into a wall outlet 2 To operate press the START button A Red light will be emitted from the light source If you desire to stop treatment before the 4 minute cycle is complete press the STOP button at any time 3 Hold the Medlight 630PRO over the area to be treated 4 The Medlight 630PRO has a built in spacer lip that will help you maintain the optimal distance from the treatment area If using the Medlight 630PRO on intact skin you may
4. k or device failure e Do not exceed three 3 treatment cycles per session Exceeding treatment cycles may cause excessive skin warming This may result in skin irritation or discomfort Cautions e Do not block device fan vents by placing device under clothing under or betweens any body part s or with Velcro Strap Blocking vent may cause device to overheat and turn off e Do not look directly at the light source The Medlight 630PRO emits high intensity light and prolonged exposure of your eyes directly to the light may cause discomfort Use of the supplied goggles is recommended during facial treatments to reduce the intensity of the light to your eyes e Do not allow the unit to come in contact with broken skin The device is not sterile and may cause infection If necessary cover the broken skin with a bandage hh C Contents of the Medlight 630PRO Medlight 630PRO Power Supply Power Supply Cord Car adapter Pain Therapy Device front back view Goggles Flexible Velcro Holding Strap A Medlight 630PRO Detail Fan Vent Light Source STARI STOP C MEDTLIGHT i an Top Label f Power Supply Connection Fan Vent T e Treatment Recommendations Medical Devices Inc recommends the use of three 4 minute treatment cycles per session During the first 4 minute treatment cycle your skin temperature will rise to a therapeutic level Continue two additional treatment cycles to achieve optimal therapeut
5. place the device directly on your skin If using the Medlight 630PRO over broken skin hold the device slightly above the skin so that it does not come in contact with the broken skin When using the device correctly you should feel a gentle warming of your skin 5 The Medlight 630PRO treatment cycle is 4 minutes Completion of the treatment cycle is indicated by an audible alarm 6 To achieve the desired pain relief two additional 4 minute treatments are recommended 7 After treatment is complete unplug the POWER SUPPLY CORD from the wall outlet Wait Light The Medlight 630PRO has an internal automatic temperature sensor that will turn the device off and illuminate the Wait Light to prevent the device from overheating When the device has cooled to an acceptable temperature the WAIT Light will turn off allowing the device to resume treatment Please refer to Cautions in Instructions for Use to help prevent overheating of device Clinical Performance Data MEDLIGHT 630PRO Time treatment cycle 4 min 1 8 min 2 12 min 3 Bicep skin temp F 103 9 106 0 107 8 Forearm skin temp F 104 1 106 9 108 0 Calf skin temp F 103 8 105 2 108 2 Note Data was collected from two subjects by performing three repetitive tests on three different body parts using a digital thermometer with an insulated cover attached to the skin of the subjects The Medlight 630PRO was placed directly onto the treatment site with the LED
6. pport issues including warranty returns and replacement parts please contact our Customer Support Department at Medical Devices Inc Customer Service Department 4600 140th Ave North Suite 200 Clearwater Florida 33 762 MedicalDEVICES IMPROVING YOUR QUALITY OF LIFE The MedLight 630 Pro was manufactured in the USA under license from Life Without Pain LLC All rights to the MedLight 630 Pro were acquired by Medical Devices Inc Medical Devices Inc will provide all product support and Warranty management for units sold by Medical Devices Inc or any of its authorized distributors or resellers PATENT PENDING _MADEINUSA _FDACLEARED activex forever IMPROVING OUTCOMES IMPROVING LIVES www ActiveForever com Yo ical DEVICES
7. rated by L E Ds no longer emitting light Environmental conditions for transport and storage Temperature range Relative humidity range within 40 C to 70 C within 10 to 75 Technical Specifications Treatment area 14 cm2 Wave length of light emitted 630 nm Joules per minute 12 Joules per 4 minute treatment cycle 48 Degree of protection against electric shock Type BF Applied Part Degree of protection against the ingress of water IPXO USE ONLY P N 1075 0030 AC Adapter Rating 100 240VAC 50 60 Hz 0 5 0 8A wit or P N 1075 0034 Car Adapter Rating 12 VDC Nominal MEDICAL EQUIPMENT HG WITH RESPECT TO ELECTRICAL SHOCK 0843 FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL IEC EN 60601 1 And CANCSA C22 2 No 601 1 Limited Warranty Medical Devices Inc MDI warrants the Medlight 630PRO device to be free from defects in workmanship and materials under normal use for a period of one 1 year from the date of purchase MDI s sole obligation under this warranty will be to repair or replace new or refurbished at its option the Medlight 630PRO Unit that proves to be defective during the warranty period The foregoing shall be the sole remedy under the warranty Except as set forth herein MDI makes no warranties either expressed or implied including the implied warranties of merchantability and fitness for a particular purpose No warranty is provided if any Medlight 630PRO Unit is modified
8. without the express written consent of MDI This warranty is not assignable and is applicable only to the Original purchaser The instructions contained in this manual in no way represent a guarantee for successful treatment SEEK MEDICAL ATTENTION IF PAIN PERSISTS DO NOT discontinue your regular medication without consulting your doctor The Medlight 630PRO Pain Therapy Device will not eliminate disease that Causes pain Replacement Parts Please use the part numbers below when ordering replacement parts Be sure to use only Medlight 630PRO parts Car Adapter 1075 0038 Goggles Warranty Replacement Procedure Below is the procedure for replacing your Medlight 630PRO unit due to defect in workmanship or materials within the one 1 year warranty period 1 The Medlight 630PRO device must be returned with copy of original purchase receipt and in original product packaging 2 Call Medical Devices Customer Service at 727 451 7160 The Customer service representative will provide you with a Return Merchandise Authorization RMA number and a return address 3 The return shipment must be prepaid and the RMA number must be displayed on the outside of the shipping container or the shipment will not be accepted by Medical Devices Inc Returns not in the original packaging will not be honored under the terms of this warranty Customer Service and Technical Support For all Customer Service and Technical Su
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