1
User Manual
Meditech International Inc.
CANADA
THE
BIOFLEX 120
A Personal Therapy System
2
3
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 identication
purposes only and are trademarks or registered trademarks of their
respective holders.
Personal User Manual CAN (MN-100.794)
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 Specications 31
Electromagnetic Compatibility (EMC) 35
BioFlex Personal Parts List 36
Notes 37
5
Introduction
For the rst 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 eective, 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 eld 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 ngertips.
The Man Behind The System
BioFlex 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 rst 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.
6
Intended Use
Prior to initiating treatment for any medical condition, it is advisable to
be examined and have a diagnosis established by a qualied health care
professional in order that more serious problems may be discovered and
to determine if light therapy will be eective for your condition.
The BioFlex 120 is a medical device designed for the safe, easy and eective
treatment of the following conditions:
Soft Tissue & Sports Injuries
Ligament & Tendon Tears
Muscle Strains
Tendonitis
Contusions
Repetitive Stress Injuries
Carpal Tunnel Syndrome
Rotator Cu Injuries
Tennis Elbow
Arthritic Conditions
Degenerative Osteoarthritis
Rheumatoid Arthritis
Vertebral Radiculopathy
Chronic Spinal Problems
General Problems
Herniated Disc
Fibromyalgia
TMJ Syndrome
Reex Sympathetic Dystrophy
Post Herpetic Neuralgia
Contraindications
The BioFlex 120 should not be used during the rst trimester of pregnancy.
In addition it should be avoided when photosensitive drugs are being
utilized. For additional advise consult your physician.
7
Important Information
It 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.
8
System Basics
The BioFlex 120 is a high performance therapy system that is aordable,
cost-eective and easy to use. The ergonomically designed Controller Unit
is connected to a exible Treatment Array in order to deliver a patented
sequence of Red and Infrared light energy to injured or diseased tissue.
Scientically 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 ve treatments and increase to higher settings, only
as required.
The Treatment Array’s soft, exible 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 conrmed via a sound.
Need more information? Visit www.bioexpersonal.com for step-by-step
tutorial videos and customer support.
9
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@bioexpersonal.com
Note: System parts may appear dierent than displayed below.
AC Adapter
Power Cable
Controller Unit
Treatment Array
Safety Glasses
Retention
Strap
10
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
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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 gure below
12
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 1
Place 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 rmly in
place either with the straps provided or manually.
Step 2
Press the power button to turn the system on or o. You’ll
hear an audible double beep and the power button will turn
blue when it is turned on.
Step 3
Press 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 4
The Treatment Stage of the BioFlex 120 automatically defaults
to stage 1 (recommended for at least the rst ve treatments).
Press the button again for stage 2 or 3, if needed.
Step 5
Press 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 selected. 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 6
Press the Stop button once at any time to pause the treatment. Press Stop twice to cancel the treatment.
14
Planning Your Treatments
Treatment Area
Light therapy is most eective when the Treatment Array is placed rmly
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 dierent 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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Stage
There are 3 pre-programmed stages for each of the 12 treatments
available on the Controller Unit. Each stage is meant for dierent 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.
Frequency
Acutely painful areas may be treated daily until the pain and other
symptoms diminish.
Possible Reactions and Side Eects
During the course of treatment, the dermis may become erythematous,
secondary to physiological eects. 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 Treatment
Treatments 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
Placements
See Figures A and B for the location of the Treatment Array when treating
jaw pain.
17
Shoulder
Common Conditions
Ligament Injury
Repetitive Stress Injury
Ligament & Tendon Tears
“Frozen” Shoulder
Arthritis (Degenerative & Rheumatoid)
Rotator Cu Injuries
Muscle Strains
Tendonitis
Contusions
Placements
See Figures A to C for the location of the Treatment Array when treating
pain in a shoulder joint.
A
C
B
18
Elbow
Common Conditions
Tennis Elbow
Soft Tissue Injuries
Arthritis (Degenerative & Rheumatoid)
Ligament & Tendon Tears
Tendonitis
Contusions
Placements
See 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 Syndrome
Soft Tissue Injuries
Ligament & Tendon Tears
Reex Sympathetic Dystrophy
Arthritis (Degenerative & Rheumatoid)
Tendonitis
Placements
See Figures A and B for the location of the Treatment Array when treating
pain in a wrist joint.
20
Hand
Common Conditions
Soft Tissue Injuries
Arthritis (Degenerative & Rheumatoid
Ligament and Tendon Tears
Reex Sympathetic Dystrophy
Tendonitis
Contusions
Placements
See Figures A and B for the location of the Treatment Array when treating
pain in the ngers.
A
B
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A B
C C
Foot
Common Conditions:
Arthritis (Degenerative & Rheumatoid)
Plantar Fasciitis
Tarsal Tunnel Syndrome
Soft Tissue Injuries
Atypical Midfoot Fasciitis
Tendonitis
Ligament & Tendon Tears
Muscle Strains
Contusions
Reex Sympathetic Dystrophy
Placements
See Figures A to C for the location of the Treatment Array when treating
pain in a foot.
22
Neck
Common Conditions
Tension Headaches
General Neck Pain
Disc Herniation
Soft Tissue Injuries
Arthritis (Degenerative & Rheumatoid)
Fibromyalgia
Placements
See 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 Pain
Fibromyalgia
Chronic Spinal Problems
Herniated Disc
Muscle Strains
Vertebral Radiculopathy
Post Herpetic Neuralgia
Arthritis (Degenerative & Rheumatoid)
Placements
See Figures A and B for the location of the Treatment Array when treating
pain in the upper back.
A
B
24
Lower Back
Common Conditions
Arthritis (Degenerative & Rheumatoid)
Disc Herniation
Muscular Back Pain
Fibromyalgia
Rotoscoliosis
Scoliosis
Chronic Spinal Problems
Placements
See Figures A to D for the location of the Treatment Array when treating
pain in the lower back.
A B
C D
25
Hip
Common Conditions
General Hip Pain
Inamed Tendons
Arthritis (Degenerative & Rheumatoid)
Tear of Labrum
Placements
See Figures A to C for the location of the Treatment Array when treating
pain in a hip joint.
A
D
B
C
26
Knee
Common Conditions
Ligament and Tendon Tears
Arthritis(Degenerative & Rheumatoid)
Muscle Strains
Contusions
Tendonitis
Reex Sympathetic Dystrophy
Supra/Infrapatellar Tendonitis
Placements
See Figures A to C for the location of the Treatment Array when treating
pain in the knee.
A B
C D
27
Ankle
Common Conditions
Arthritis (Degenerative & Rheumatoid)
Tarsal Tunnel Syndrome
Reex Sympathetic Dystrophy
Ligament and Tendon Tears
Muscle Strains
Contusions
Tendonitis
Placements
See 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.
29
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 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 Solution
No 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 o 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.
31
System Specifications
Electrical Specications
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
Classication
(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 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. - Medical Electrical Equipment - Part 1: General Requirements
for Safety
International Standards
IEC/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 Unit
Consult User Manual
Refer to the User Manual instructions.
TYPE BF APPLIED PART
This product is classied as a Type BF Applied
Part, according to the degree of protection
against electric shock.
Waste Electrical and Electronic
Equipment Directive
This 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 Label
This label shows the models and serial numbers
(S/N) of your system’s components.
REVISIONS
DESCRIPTION
DATE
APPROVED
NOTES:
Size: 1” x 0.5“(printable) or any size that will fit
legibly over a 5mm OD cable
Material:Self laminating white/clear label
Outline is forreference only
Label must be UL recgonized, and ROHS
complient
S/N: 942 0
J O B : 0510524 D
MODEL: SLD
+120
Oct 29 2015
Add QR Code Details
Initial Release
Nov 27 2015
Serial Number System
05 10 524D-9420-I
S/N
Region
MFG Code
Year
Month
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Treatment Array
CAUTION SURFACES MAY
GET HOT
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
used again.
CLASS I LED
Class I LED
This product uses LEDs that under normal use
do not pose a danger to the eyes.
General Warning Symbol
UL Mark
The UL mark is a registered trademark of the
Underwriters Laboratories Inc. with respect
to electric shock, re, mechanical and other
specied hazards.
35
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 specied 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.
36
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
37
Notes
38
Notes
39
Notes
40
415 Horner Ave Unit 12
Toronto, ON, CAN
M8W 4W3
A12233 ISO 13485
Meditech International Inc
Tf.1-844-770-0177
info@bioexpersonal.com
www.bioexpersonal.com
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