Meditech BioFlex 120 User Manual

Personal therapy system

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BIOFLEX 120
THE
A
Personal Therapy System
User Manual
Meditech International Inc.
CANADA
1

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Summary of Contents for Meditech BioFlex 120

  • Page 1 BIOFLEX 120 Personal Therapy System User Manual Meditech International Inc. CANADA...
  • Page 3 Meditech International Inc. Every precaution has been taken in the preparation of this publication. Meditech assumes no responsibility for errors or omissions. Neither is any liability assumed for damages resulting from the use of the information contained herein.
  • Page 4: Table Of Contents

    Table Of Contents Introduction Intended Use Important Information System Basics What’s In The Box Connecting The System Connecting The System Getting Started Planning Your Treatments Cleaning System Troubleshooting System Specifications Electromagnetic Compatibility (EMC) BioFlex Personal Parts List Notes...
  • Page 5: Introduction

    At Meditech International we view this system as a major advance in the immediate relief of pain and other symptoms. Pathologies are resolved – as a result of the initiation of a cascade of physiological activities that lead to the restoration of normal cell structure and function.
  • Page 6: Intended Use

    The BioFlex 120 is a medical device designed for the safe, easy and effective treatment of the following conditions: Soft Tissue &...
  • Page 7: Important Information

    • Use carefully. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the BioFlex 120 system by children/infants or incapacitated persons may be dangerous. Keep the system out of the reach of children.
  • Page 8: System Basics

    System Basics The BioFlex 120 is a high performance therapy system that is affordable, cost-effective and easy to use. The ergonomically designed Controller Unit is connected to a flexible Treatment Array in order to deliver a patented sequence of Red and Infrared light energy to injured or diseased tissue.
  • Page 9: What's In The Box

    What’s In The Box When you receive your BioFlex Personal System, check to determine that all of the parts shown below are included and undamaged. If parts are missing or damaged, contact BioFlex immediately at 1-844-770-0177 or customerservice@bioflexpersonal.com Note: System parts may appear different than displayed below. AC Adapter Power Cable Controller Unit...
  • Page 10: Connecting The System

    Connecting The System This is as easy as 1-2-3: 1. Connect the power cord, AC adapter and Controller as shown 2. Connect the Controller Unit to AC adapter...
  • Page 11: Connecting The System

    Connecting The System 3. Connect Treatment Array to Controller Unit, Squeezing the sides of the Treatment Array connector together to easily insert - and remove. Your fully connected system should look like the following figure below...
  • Page 12: Getting Started

    Getting Started Controller Unit Neck Face Shoulder Upper Back Elbow Lower Back Wrist Hand Knee Foot Ankle Treatment Stage Timer Power Stop Start/ Select Button Pause Stage Treatment Array Strap Anchor Points Treatment LEDs Power LED Top View of Treatment Array Bottom View of Treatment Array...
  • Page 13 (e.g., face, knee, etc.). When selected, the circle will turn blue. Step 4 The Treatment Stage of the BioFlex 120 automatically defaults to stage 1 (recommended for at least the first five treatments). Press the button again for stage 2 or 3, if needed.
  • Page 14: Planning Your Treatments

    Planning Your Treatments Treatment Area Light therapy is most effective when the Treatment Array is placed firmly over the dermis and directly over the focal point of the painful area. Identify the focus of the pain in the area being treated and apply the Array over that particular area.
  • Page 15 Stage There are 3 pre-programmed stages for each of the 12 treatments available on the Controller Unit. Each stage is meant for different stages of the healing process. Stage 1 provides the best results for most cases and should be used for as long as possible. Using stage 2 is only advisable if there is no improvement after 5-10 full treatments.
  • Page 16 Face Common Conditions TMJ Disorder Postherpetic Neuralgia Placements See Figures A and B for the location of the Treatment Array when treating jaw pain.
  • Page 17 Shoulder Common Conditions Ligament Injury Rotator Cuff Injuries Repetitive Stress Injury Muscle Strains Ligament & Tendon Tears Tendonitis “Frozen” Shoulder Contusions Arthritis (Degenerative & Rheumatoid) Placements See Figures A to C for the location of the Treatment Array when treating pain in a shoulder joint.
  • Page 18 Elbow Common Conditions Tennis Elbow Ligament & Tendon Tears Soft Tissue Injuries Tendonitis Arthritis (Degenerative & Rheumatoid) Contusions Placements See Figures A to C for the location of the Treatment Array when treating pain in an elbow joint.
  • Page 19 Wrist Common Conditions Carpal Tunnel Syndrome Reflex Sympathetic Dystrophy Soft Tissue Injuries Arthritis (Degenerative & Rheumatoid) Ligament & Tendon Tears Tendonitis Placements See Figures A and B for the location of the Treatment Array when treating pain in a wrist joint.
  • Page 20 Hand Common Conditions Soft Tissue Injuries Reflex Sympathetic Dystrophy Arthritis Tendonitis (Degenerative & Rheumatoid Ligament and Tendon Tears Contusions Placements See Figures A and B for the location of the Treatment Array when treating pain in the fingers.
  • Page 21 Foot Common Conditions: Arthritis Tendonitis (Degenerative & Rheumatoid) Plantar Fasciitis Ligament & Tendon Tears Tarsal Tunnel Syndrome Muscle Strains Soft Tissue Injuries Contusions Atypical Midfoot Fasciitis Reflex Sympathetic Dystrophy Placements See Figures A to C for the location of the Treatment Array when treating pain in a foot.
  • Page 22 Neck Common Conditions Tension Headaches Soft Tissue Injuries General Neck Pain Arthritis (Degenerative & Rheumatoid) Disc Herniation Fibromyalgia Placements See Figures A to D for the location of the Treatment Array when treating neck pain.
  • Page 23 Upper Back Common Conditions Muscular Back Pain Muscle Strains Fibromyalgia Vertebral Radiculopathy Chronic Spinal Problems Post Herpetic Neuralgia Herniated Disc Arthritis (Degenerative & Rheumatoid) Placements See Figures A and B for the location of the Treatment Array when treating pain in the upper back.
  • Page 24 Lower Back Common Conditions Arthritis Rotoscoliosis (Degenerative & Rheumatoid) Disc Herniation Scoliosis Muscular Back Pain Chronic Spinal Problems Fibromyalgia Placements See Figures A to D for the location of the Treatment Array when treating pain in the lower back.
  • Page 25 Common Conditions General Hip Pain Arthritis (Degenerative & Rheumatoid) Inflamed Tendons Tear of Labrum Placements See Figures A to C for the location of the Treatment Array when treating pain in a hip joint.
  • Page 26 Knee Common Conditions Ligament and Tendon Tears Tendonitis Arthritis Reflex Sympathetic Dystrophy (Degenerative & Rheumatoid) Muscle Strains Supra/Infrapatellar Tendonitis Contusions Placements See Figures A to C for the location of the Treatment Array when treating pain in the knee.
  • Page 27 Ankle Common Conditions Arthritis Muscle Strains (Degenerative & Rheumatoid) Tarsal Tunnel Syndrome Contusions Reflex Sympathetic Dystrophy Tendonitis Ligament and Tendon Tears Placements See Figures A to D for the location of the Treatment Array when treating pain in the ankle.
  • Page 28: Cleaning

    Cleaning Clean the Treatment Array after each treatment using an alcohol wipe, soft disinfectant or a soft damp cloth. Do not immerse or rinse the Treatment Array in water. Clean the Controller Unit using a soft damp or disinfectant cloth when needed. When dirty, wash the straps in a washing machine using the gentle cycle and allow to air dry.
  • Page 29: System Troubleshooting

    System Troubleshooting This section summarizes the most common problems you could encounter with the Personal system. If you are unable to solve the problem with the information below, contact BioFlex Service at 1-844-770-0177. Issue Possible Cause Solution Part or all of the System has been Check all power system becomes...
  • Page 30 Issue Possible Cause Solution No power or The power supply Plug the power supply display is blank. is not connected. into a wall outlet. Power is not Ensure the cable is turned on. plugged into the Controller Unit. The Unit will beep once the power is connected.
  • Page 31: System Specifications

    System Specifications Electrical Specifications Rated voltage 100-240V Rated frequency 50-60 Hz Operating Conditions Temperature +5°C to +40°C Relative humidity 15% to 93% (non-condensing) Atmospheric pressure 700hPa to 1,060hPa Storage Conditions Temperature / humidity -25°C without relative humidity control +70°C at a relative humidity up to 93%, non-condensing Classification (Sub-clause 6 of IEC 60601-1 and Clause 6 of IEC 60601-1:2005)
  • Page 32 Canadian Standards CAN/CSA C22.2 No. 60601.1, Third ed. - Medical Electrical Equipment - Part 1: General Requirements for Safety CAN/CSA C22.2 No. 601-1.M90 - Medical Electrical Equipment – Part 1: General Requirements for Safety Canadian and United States of America standards UL 60601-1, First ed.
  • Page 33 SHEET 1 OF 1 FINISH FILE: Y 14.5 M 120snLabel.pdf PROPRIETARY AND CONFIDENTIAL ONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF MEDITECH INTERNATIONAL INC. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF MEDITECH INTERNATIONAL INC IS PROHIBITED.
  • Page 34 Treatment Array Heat Warning It is normal for the Treatment Array surface to get warm after extended use. In the event that the Treatment Array gets hot, the system will pause until the temperature has dropped. The Treatment Array needs to be cooled for at least 15 minutes before it is CAUTION SURFACES MAY used again.
  • Page 35: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) This equipment complies with the European rules for EMC according to the safety standard IEC 60601-1-2. This device complies with EMC rules under test conditions that include use of system cables and connectors between system components. This Equipment requires special precaution regarding the EMC and must be installed and put into service according to the information provided in this manual.
  • Page 36: Bioflex Personal Parts List

    BioFlex Personal Parts List Components Part No. Controller Unit DW100.785 Personal 120 Treatment Array DW400.004 Carrying Case CT402.009 User Manual - Canada MN100.794 User Manual - USA MN421.000 Power Supply CT402.006 Power Cord CT100.171 Safety Glasses CT402.016...
  • Page 37: Notes

    Notes...
  • Page 38 Notes...
  • Page 39 Notes...
  • Page 40 415 Horner Ave Unit 12 Tf.1-844-770-0177 Toronto, ON, CAN info@bioflexpersonal.com M8W 4W3 www.bioflexpersonal.com A12233 ISO 13485 Meditech International Inc...

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