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User ManualMeditech International Inc.

USA

THE BIOFLEX 120A Personal Therapy System

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Meditech International Inc.

Copyright © 2015 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.

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.

All brand and product names mentioned are used for identification purposes only and are trademarks or registered trademarks of their respective holders.

Personal User Manual CAN (MN-421.000)

1st Edition December 2015

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Table Of Contents

Introduction 5

Intended Use 6

Important Information 7

System Basics 8

What’s In The Box 9

Connecting The System 10

Connecting The System 11

Getting Started 12

Planning Your Treatments 14

Cleaning 28

System Troubleshooting 29

System Specifications 31

Electromagnetic Compatibility (EMC) 35

BioFlex Personal Parts List 36

Notes 37

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IntroductionFor the first time in history Meditech International has produced an automated, pre-programmed light therapy device that can be applied at home, while travelling or while otherwise engaged.

This highly effective, sophisticated unit is a derivative product of the BioFlex Professional Laser Therapy Systems that have achieved a high level of distinction in medical clinics based on the resolution of many pathologies, often representing dramatic clinical outcomes.

Currently utilized in the field of Laser Medicine by health care professionals in over 50 countries worldwide, the technology is widely applicable in the treatment of musculoskeletal conditions, arthritis, sports and soft tissue injuries, etc., on a scalable basis.

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.

With the purchase of this unit, you hold the key to a non-invasive solution for many of your medical problems, at your fingertips.

The Man Behind The SystemBioFlex is a division of Meditech International Inc. a company founded by Fred Kahn, MD, in 1989. The company designs and manufacturers leading edge Laser Therapy Systems.

In 1993, Meditech opened its first clinic within a laboratory at Ryerson University which has evolved into two major Laser Rehabilitation Clinics currently active in Toronto. All products represent the synergy developed through the collaboration of clinicians, engineers and designers, innovating and improving the development of new technologies.

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Intended UsePrior to initiating treatment for any medical condition, it is advisable to be examined and have a diagnosis established by a qualified health care professional in order that more serious problems may be discovered and to determine if light therapy will be effective for your condition.

The BioFlex Personal is a medical device designed for safe easy and effective temporary relief of minor muscle and joint pain, arthritis, muscle spasm, stiffness and promoting muscle relaxation in the body.

ContraindicationsThe BioFlex 120 should not be used during the first trimester of pregnancy. In addition it should be avoided when photosensitive drugs are being utilized. For additional advise consult your physician.

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Important InformationIt is appropriate to read and understand this User Manual. Failure to follow the instructions noted may result in problems and void the product warranty. If you have any questions, call BioFlex at 1-844-770-0177.

• This device is to be utilized for the conditions listed in this manual.

• The device is to be used in a dry environment only and must be kept dry at all times.

• The system is not waterproof. Do not get it wet or rinse under water. Do not use while bathing.

• Do not use the system while operating a vehicle or machinery.

• Do not use the system as a passenger in a vehicle. The bright light may distract the driver.

• Do not exert excessive pressure or twist/bend the system parts. Keep the Treatment Array away from sharp objects as they may puncture it.

• Do not pull, kink or pinch the cables. Never tightly wrap cables around the Treatment Array.

• Do not drop the system.

• Do not open or modify any part of the system.

• Choking hazard: Do not wrap cords or straps around the neck.

• Do not cover the Treatment Array during treatment.

• Do not use the system to treat over the eyes. It is inappropriate to shine the light emanating from the Treatment Array into the eyes.

• Use the provided glasses if your eyes are sensitive to the bright light coming from the Treatment Array. Do not use the glasses for any purpose other than for treatment with the BioFlex 120 system.

• Do not leave the device unattended when it is running.

• 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.

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System BasicsThe 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.

Scientifically and clinically developed protocols have been pre-programmed for 12 anatomical regions. Simply select the desired area of treatment from the face of the Controller Unit to start treatment. Three Stages of protocols are available for each area. Initiate treatment at Stage 1 for at least the initial five treatments and increase to higher settings, only as required.

The Treatment Array’s soft, flexible material is easy to clean and readily adjusts to the contours of the area to which it is applied. For optimal results, apply the Array to the skin’s surface and if desired, hold in place with straps provided. Holding the system in place with a hand is also appropriate. Do not cover the Treatment Array throughout the course of therapy.

Each treatment is initiated by radiation of red light automatically followed by infrared radiation. The latter is not visible to the human eye. Once the treatment has been completed, it will be confirmed via a sound.

Need more information? Visit www.bioflexpersonal.com for step-by-step tutorial videos and customer support.

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What’s In The BoxWhen 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

Treatment Array

Safety Glasses

Retention Strap

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Connecting The SystemThis 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

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Connecting The System3. 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

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Power Button

Stop Start/Pause

Select Stage

Neck

Upper Back

Lower Back

Hip

Knee

Ankle

Treatment Stage

Strap Anchor Points

Treatment LEDs

Face

Shoulder

Elbow

Wrist

Hand

Foot

Timer

Top View of Treatment Array Bottom View of Treatment Array

Getting Started

Treatment Array

Power LED

Controller Unit

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Step 1Place the Treatment Array on the area to be treated. Keep it applied to the skin to ensure maximum transmission of light into the tissues. The Treatment Array may be held firmly in place either with the straps provided or manually.

Step 2Press the power button to turn the system on or off. You’ll hear an audible double beep and the power button will turn blue when it is turned on.

Step 3Press the circle on the Controller Unit that corresponds to the area of the body to be treated (e.g., face, knee, etc.). When selected, the circle will turn blue.

Step 4The 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.

Step 5Press the Start/Pause button to begin the treatment. There will be an audible beep and the countdown timer will begin. The length of each treatment varies depending on the area select-ed. For optimal results, run the treatment to completion (until the timer ends).

If you need to stop or pause your treatment for any reason, press the Start/Pause button. Pressing the Start/Pause button again will resume your treatment.

Step 6Press the Stop button once at any time to pause the treat-ment. Press Stop twice to cancel the treatment.

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Planning Your TreatmentsTreatment AreaLight 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. The treatment may be completed by applying to the opposing area in order to apply therapy from all perspectives applicable to the region.

There are 12 different treatment guidelines for each body area. The diagram below shows which page to refer to for each area.

Neck Pg.22

Upper Back Pg.23

Lower Back Pg.24

Hip Pg.25

Knee Pg.26

Ankle Pg.27

Face Pg.16

Shoulder Pg.17

Elbow Pg.18

Wrist Pg.19

Hand Pg.20

Foot Pg.21

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StageThere 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. Skipping from stage 1 to stage 2 may result in less pain relief. Stage 3 should only be used if stage 2 no longer provides any pain relief after 5-10 treatments.

FrequencyAcutely painful areas may be treated daily until the pain and other symptoms diminish.

Possible Reactions and Side EffectsDuring the course of treatment, the dermis may become erythematous, secondary to physiological effects. This condition is not harmful and will disappear following completion of treatment. Use the glasses provided throughout the course of treatment, however they are not essential.

End of TreatmentTreatments end automatically unless you press the Stop button prior to that occurrence. Clean the Treatment Array after each use (see page 28).

As your symptoms diminish you may reduce the frequency of treatments and in order to avoid recurrence, treat once or twice per week. For chronic pain, treat as required for maintenance purposes.

Should your pain not diminish after utilizing the three Stages provided for each area, it is appropriate to consult a physician.

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A

B

Face

Common Conditions TMJ Disorder Postherpetic Neuralgia

PlacementsSee Figures A and B for the location of the Treatment Array when treating jaw pain.

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Shoulder

Common Conditions Ligament InjuryRepetitive Stress InjuryLigament & Tendon Tears“Frozen” ShoulderArthritis (Degenerative & Rheumatoid)

Rotator Cuff InjuriesMuscle StrainsTendonitisContusions

PlacementsSee Figures A to C for the location of the Treatment Array when treating pain in a shoulder joint.

A

C

B

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Elbow

Common Conditions Tennis ElbowSoft Tissue InjuriesArthritis (Degenerative & Rheumatoid)

Ligament & Tendon TearsTendonitis

Contusions

PlacementsSee Figures A to C for the location of the Treatment Array when treating pain in an elbow joint.

A B

C

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A

B

Wrist

Common Conditions Carpal Tunnel SyndromeSoft Tissue InjuriesLigament & Tendon Tears

Reflex Sympathetic DystrophyArthritis (Degenerative & Rheumatoid)

Tendonitis

PlacementsSee Figures A and B for the location of the Treatment Array when treating pain in a wrist joint.

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Hand

Common Conditions Soft Tissue InjuriesArthritis (Degenerative & Rheumatoid

Ligament and Tendon Tears

Reflex Sympathetic DystrophyTendonitisContusions

PlacementsSee Figures A and B for the location of the Treatment Array when treating pain in the fingers.

A

B

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A B

C C

Foot

Common Conditions:Arthritis (Degenerative & Rheumatoid)

Plantar Fasciitis Tarsal Tunnel SyndromeSoft Tissue InjuriesAtypical Midfoot Fasciitis

TendonitisLigament & Tendon TearsMuscle Strains Contusions Reflex Sympathetic Dystrophy

PlacementsSee Figures A to C for the location of the Treatment Array when treating pain in a foot.

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Neck

Common Conditions Tension HeadachesGeneral Neck PainDisc Herniation

Soft Tissue InjuriesArthritis (Degenerative & Rheumatoid)

Fibromyalgia

PlacementsSee Figures A to D for the location of the Treatment Array when treating neck pain.

A B

C D

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Upper Back

Common Conditions Muscular Back PainFibromyalgiaChronic Spinal ProblemsHerniated Disc

Muscle StrainsVertebral RadiculopathyPost Herpetic Neuralgia

Arthritis (Degenerative & Rheumatoid)

PlacementsSee Figures A and B for the location of the Treatment Array when treating pain in the upper back.

A

B

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Lower Back

Common Conditions Arthritis (Degenerative & Rheumatoid)

Disc Herniation Muscular Back PainFibromyalgia

RotoscoliosisScoliosisChronic Spinal Problems

PlacementsSee Figures A to D for the location of the Treatment Array when treating pain in the lower back.

A B

C D

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Hip

Common Conditions General Hip PainInflamed Tendons

Arthritis (Degenerative & Rheumatoid)

Tear of Labrum PlacementsSee Figures A to C for the location of the Treatment Array when treating pain in a hip joint.

A

D

B

C

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Knee

Common Conditions Ligament and Tendon TearsArthritis(Degenerative & Rheumatoid)

Muscle StrainsContusions

TendonitisReflex Sympathetic DystrophySupra/Infrapatellar Tendonitis

PlacementsSee Figures A to C for the location of the Treatment Array when treating pain in the knee.

Knee

Common Conditions Ligament and Tendon TearsArthritis(Degenerative & Rheumatoid)

Muscle StrainsContusions

TendonitisReflex Sympathetic DystrophySupra/Infrapatellar Tendonitis

PlacementsSee Figures A to C for the location of the Treatment Array when treating pain in the knee.

A B

C D

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Ankle

Common Conditions Arthritis (Degenerative & Rheumatoid)

Tarsal Tunnel SyndromeReflex Sympathetic DystrophyLigament and Tendon Tears

Muscle StrainsContusionsTendonitis

PlacementsSee Figures A to D for the location of the Treatment Array when treating pain in the ankle.

A B

C D

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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.

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System TroubleshootingThis 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 SolutionPart or all of the system becomes damaged and does not work.

System has been dropped or damaged somehow.

Check all power connections. Make sure all cables are secure and properly connected.

Press the Power button on the Controller Unit. If it does not power on, contact BioFlex Service.

System has become wet.

Liquids from spills or excessive humidity.

Immediately unplug all system components from the electrical outlet. Contact BioFlex Service.

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Issue Possible Cause SolutionNo power or display is blank.

The power supply is not connected.

Power is not turned on.

Plug the power supply into a wall outlet.

Ensure the cable is plugged into the Controller Unit. The Unit will beep once the power is connected.

Press the Power button.System beeps and displays an E01 error.

The Treatment Array is not connected properly.

Unplug and re-plug the Treatment Array and press the start/pause button on the Controller Unit to continue the treatment. If problem persists, contact BioFlex Service.

System beeps and displays an E02 error.

The Treatment Array is hot (temperature exceeds 48°C) due to being covered or running too long.

In the event that the Treatment Array gets too hot, it will shut off until the temperature has dropped.

The Treatment Array needs to be cooled for at least 15 minutes before it is used again.

System beeps and displays an E03 error.

The Teatment Array cable may have been removed unexpectedly.

The temperature sensor has malfunctioned.

Make sure the cable is properly connected to the Controller.

If problem persists, contact BioFlex Service.

System beeps and displays an E04, E05, E06, E07, E08, E09, E10, E11 or E12 error.

The system has malfunctioned.

Record the error code and contact BioFlex Service for further assistance.

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System SpecificationsElectrical SpecificationsRated voltage 100-240V

Rated frequency 50-60 Hz

Operating ConditionsTemperature +5°C to +40°C

Relative humidity 15% to 93% (non-condensing)

Atmospheric pressure 700hPa to 1,060hPa

Storage ConditionsTemperature / 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)

CLASS I EQUIPMENT, according to the type of protection against electric shock

TYPE BF APPLIED PART, according to the degree of protection against electric shock;

NOT CLASSIFIED, according to the degree of protection against harmful ingress of water;

CONTINUOUS OPERATION, according to the mode of operation

NONE OF THE PARTS OF THE SYSTEM ARE STERILIZED

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Canadian StandardsCAN/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. - Medical Electrical Equipment - Part 1: General Requirements for Safety

International StandardsIEC/EN 60601-1, Second ed. - Medical Electrical Equipment -Part 1: General Requirements for Safety

ANSI/AAMI ES60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 - Medical Electrical Equipment - Part 1: General Requirements for Safety - 2. Collateral Standard: Electromagnetic Compatibility -Requirements and Tests

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Warning Symbols and Labels

Controller UnitConsult User ManualRefer to the User Manual instructions.

TYPE BF APPLIED PART This product is classified as a Type BF Applied Part, according to the degree of protection against electric shock.

Waste Electrical and Electronic Equipment DirectiveThis symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.Model and Serial Number LabelThis label shows the models and serial numbers (S/N) of your system’s components.

REVISIONS

ZONE REV. DESCRIPTION DATE APPROVED

THE INFORMATION CONTAINED 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.

SHEET 1 OF 1SCALE: 1:1 WEIGHT:

REVDWG. NO.ASIZE

DESCRIPTION:

Meditech International Inc.NAME DATE

Q.A.

MFG APPR.

ENG APPR.

CHECKED

DESIGNED

FINISH

MATERIAL

INTERPRET GEOMETRICTOLERANCING PER:

TOLERANCES:X mmX.X mmX.XX mmANGULAR: MACH BEND

5 4 3 2 1

SIGN.

FILE:

DIMENSIONS ARE IN mm

120snLabel.pdf

411 Horner Ave., Unit 1, Etobicoke, ON, Canada M8W4W3 Tel: (416) 251-1055 Fax: (416) 251-2446

PROPRIETARY AND CONFIDENTIAL

FIRST ANGLE PROJECTION

ANSI Y 14.5 M

MACHINING NOTES:ON HOLE & INT. THREAD LOCATION IS BREAK ALL SHARP EDGES 0.1 - 0.4 RAD. OR 45 CHAMFER

UNLESS OTHERWISE SPECIFIED:

NOTES:Size: 1” x 0.5“(printable) or any size that will fit legibly over a 5mm OD cableMaterial: Self laminating white/clear labelOutline is for reference onlyLabel must be UL recgonized, and ROHScomplient

Example s/n label (for reference ONLY)S/N

MFG code

Year

Month

05 10 524D-9420_ _ _ _ _ _ _ _ _ _ _ _

Job/S/N

S/N: 9420JOB: 0510524DMODEL: SLD+120

DW103.021 1

120 Serial Number Label

Oct 29 2015

R.Bramer

0

1 Add QR Code Details

Initial Release

Nov 27 2015

SLD1200510524D9420

QR System(string) to Print

Job/Serial Numbering System

Nov 27 2015

Serial Number System

05 10 524D-9420-I

S/NRegion

MFG CodeYearMonth

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Treatment Array

CAUTION SURFACES MAY GET HOT

Heat WarningIt 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 used again.

CLASS I LEDClass I LEDThis product uses LEDs that under normal use do not pose a danger to the eyes.General Warning Symbol

UL MarkThe UL mark is a registered trademark of the Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical and other specified hazards.

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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.

The use of accessories and cables other than those specified and sold by the manufacturer may result in increased emissions or decreased immunity of the equipment and may cause the system to be non-compliant with the requirements of 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. It may be necessary to take mitigation measures, such as reorienting or relocating the equipment or shielding the location.

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BioFlex Personal Parts List

Components Part No.

Controller Unit

Personal 120 Treatment Array

Carrying Case

User Manual - Canada

User Manual - USA

Power Supply

Power Cord

Safety Glasses

DW100.785

DW400.004

CT402.009

MN100.794

MN421.000

CT402.006

CT100.171

CT402.016

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Notes

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Notes

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Notes

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415 Horner Ave Unit 12Toronto, ON, CANM8W 4W3

A12233 ISO 13485Meditech International Inc

Tf.1-844-770-0177info@bioflexpersonal.comwww.bioflexpersonal.com