BIOFLEX 180 User Manual

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BIOFLEX 180

THE

A Personal Therapy System

User Manual

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Page 1 BIOFLEX 180 A Personal Therapy System User Manual...
Page 2 THE BIOFLEX 180 A Personal Therapy System Meditech International Inc. Copyright © 2016 Meditech International Inc. All rights reserved. No part of this publication may be reproduced, translated into another language, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior written consent of Meditech International Inc.
Page 3: Table Of Contents
Table Of Contents Introduction System Basics Planning Your Treatments Conditions Treated and Placement of Array What’s In The Box Connecting The System Initiating Therapy Application Of Treatment Important Information System Troubleshooting System Specifications Electromagnetic Compatibility (EMC) BioFlex Personal Parts List Notes...
Page 4: Introduction
Introduction The BioFlex 180, for the first time in the history of the application of light therapy, has the capacity to deliver automated, pre-programmed treatment protocols for an extensive number of medical conditions. The system can be easily applied at home, while travelling or otherwise engaged.
Page 5: System Basics
System Basics The BioFlex 180 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 therapy to injured or diseased tissue automatically.
Page 6: Planning Your Treatments
Planning Your Treatments Light therapy is most effective when the Treatment Array is placed firmly over the dermis and directly over the focal point of the pain. 60% of the treatment time, both Red and Infrared, should be devoted to that general region.
Page 7 Additional Instructions: Some of these steps have already been described but are repeated for confirmation. • 60% of the Red and Infrared treatment time prescribed for each condition should be devoted to the area where the pain and other symptoms are most severe. The remaining period of time should be applied more widely to the adjacent areas.
Page 8 Possible Reactions and Side Effects The dermis may become discolored, secondary to physiological changes. This condition is of minimal concern and should disappear subsequent to treatment. One can use the glasses provided for ocular protection, however they are not essential. It is generally good practice to wear them when treating the upper body regions or the facial area.
Page 9: Conditions Treated And Placement Of Array
More specialized conditions involving each of the areas for which protocols are provided will be described in the appropriate sections. (p.10-21) The BioFlex Personal is a medical device designed for safe, easy and effective temporary relief of minor muscle and joint pain, arthritis, muscle...
Page 10 Face Common Conditions Treated TMJ Pain Placements A and B direct the location of the Array when facial structures are involved. (Avoid placements close to eyes) Oblique Transverse...
Page 11 Shoulder Common Conditions Treated Joint Pain Muscle Pain Arthritis Tendonitis Soft Tissue Injuries Placements A to C direct the location of the Array when treating the shoulder joint. Superior Lateral Vertical...
Page 12 Elbow Common Conditions Treated Joint Pain Muscle Pain Tennis Elbow Arthritis Soft Tissue Injuries Tendonitis Placements A to D direct the location of the Array when treating the elbow joint. Either combination of placements are acceptable (i.e. A and B or C and D). Medial Lateral Posterior...
Page 13 Wrist Common Conditions Treated Joint Pain Tendonitis Soft Tissue Injuries Arthritis Placements A to D direct the location of the Array when treating the wrist joint. Placements A and B are preferable however in some instances C and D may be more appropriate. Dorsal Ventral (Palmar) Dorsal Longitudinal...
Page 14 Hand/Digits Common Conditions Treated Joint Pain Tendonitis Soft Tissue injuries Arthritis Placements A and B direct the location of the Array when treating the hands. The wrist and hand/digits may be treated separately or jointly depending on the dimensions of the area involved. In some situations C and D may be preferable.
Page 15 Foot Common Conditions Treated Arthritis Joint Pain Tendonitis Soft Tissue Injuries Muscle Pain Placements A to D direct the location of the Array when treating the foot. Place according to major area of pain. Dorsal Transverse Plantar Transverse (Forefoot) Plantar Longitudinal Dorsal Longitudinal (Mid-foot)
Page 16 Ankle Common Conditions Treated Arthritis Tendonitis Joint Pain Muscle Pain Soft Tissue Injuries Placements A to C direct the location of the Array when treating the ankle. Anterior Posterior Inferior...
Page 17 Cervical Spine (Neck) Common Conditions Treated Arthritis Tendonitis Joint Pain Muscle Pain Soft Tissue Injuries Placements A to D direct the location of the Array when treating the neck. Vertical Transverse Right Lateral Left Lateral...
Page 18 Thoracic Spine (Upper Back) Common Conditions Treated Soft Tissue Injuries Muscle Spasm Muscle Pain Placements A and B direct the location of the Array when treating the upper back. Schematic outlines indicate additional placements. Vertical 1 or 2 placements Transverse 1 or 2 placements...
Page 19 Lumbar Spine (Lower Back) Common Conditions Treated Soft Tissue Injuries Muscle Pain Muscle Spasm Placements A to D direct the location of the Array when treating the lower back. Schematic outlines indicate additional placements. Transverse Vertical Left Oblique Right Oblique (sciatic) (sciatic)
Page 20 Common Conditions Treated Arthritis Joint Pain Tendonitis Soft Tissue Injuries Muscle Pain Placements A to F direct the location of the Array when treating the hip joint. Treatment can be applied using transverse or vertical placements extending from the mid-line anteriorly to the mid-line posteriorly. Vertical approach may require 4 or 5 individual placements.
Page 21 Knee Common Conditions Treated Arthritis Tendonitis Joint Pain Muscle Pain Soft Tissue Injuries Placements A to F direct the location of the Array when treating the knee. It is important to treat the entire circumference of the joint, always devoting more time to the primary focus of symptoms.
Page 22: What's In The Box
What’s In The Box When you receive your BioFlex Personal System, check to make certain that all of the parts shown below are included and undamaged. If parts are missing or damaged, contact BioFlex at 1-844-770-0177 or customerservice@biofl expersonal.com AC Adapter...
Page 23: 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 24 3. Connect Treatment Array to Controller Unit, squeeze the sides of the Treatment Array connector fi rmly to insert easily - and squeeze again to remove. Your fully connected system should appear as demonstrated below.
Page 25: Initiating Therapy
Initiating Therapy Controller Unit Face Neck Upper Back Shoulder Elbow Lower Back Wrist Hand Knee Foot Ankle Treatment Stage Timer Power Stop Start/ Select Button Pause Stage Treatment Array Treatment Array Strap Anchor Points Treatment LEDs Power LED Top View of Treatment Array Bottom View of Treatment Array...
Page 26: Application Of Treatment
Step 4 The Treatment Stage of the BioFlex 180 automatically selects Stage 1 (recommended for at least the fi rst fi ve treatments or longer). Press the button again for Stage 1 - 4, as required.
Page 27: Important Information
• Use carefully. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the BioFlex 180 system by children/infants or incapacitated persons may be dangerous. Keep the system out of the reach of children.
Page 28: System Troubleshooting
System Troubleshooting This section summarizes the most common problems encountered with the Personal System. If you are unable to solve the problem with the information below, contact BioFlex Service at 1-844-770-0177. Problem Possible Cause Solution Part or all of the...
Page 29 E01 error. properly. the start/pause button on the Controller Unit to continue the treatment. If problem persists, contact BioFlex Service. System beeps The Treatment Array In the event that the and displays is hot (temperature Treatment Array gets too an E02 error.
Page 30: 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 31 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 32 REVISIONS ZONE REV. DESCRIPTION DATE APPROVED Oct 29 2015 Initial Release Warning Symbols and Labels Nov 27 2015 Add QR Code Details Controller Unit Consult User Manual Refer to the User Manual instructions. NOTES: Size: 1” x 0.5“(printable) or any size that will fit TYPE BF APPLIED PART legibly over a 5mm OD cable Material: Self laminating white/clear label...
Page 33 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 34: Electromagnetic Compatibility (Emc)
IEC 60601-1-2. Replace cables and connectors between components only with BioFlex approved cables and connectors. This system may cause radio interference or may disrupt the operation of nearby equipment.
Page 35: Bioflex Personal Parts List
BioFlex Personal Parts List Components Part No. Controller Unit DW100.785 Personal 180 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 36: Notes
Notes...
Page 37 Notes...
Page 38 Notes...
Page 39 Notes...
Page 40 415 Horner Ave Unit 12 Tf.1-844-770-0177 Toronto, ON, CAN info@bioﬂ expersonal.com M8W 4W3 www.bioﬂ expersonal.com A12233 ISO 13485 Meditech International Inc...

BIOFLEX 180 User Manual

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Summary of Contents for BIOFLEX 180

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