the bioflex 120 - Bioflex Personal

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the bioflex 120 - Bioflex Personal
THE
BIOFLEX 120
A Personal Therapy System
User Manual
Meditech International Inc.
USA
1
2
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
3
Table Of Contents
Introduction5
Intended Use6
Important Information7
System Basics8
What’s In The Box9
Connecting The System10
Connecting The System11
Getting Started12
Planning Your Treatments14
Cleaning 28
System Troubleshooting29
System Specifications31
Electromagnetic Compatibility (EMC)35
BioFlex Personal Parts List36
Notes37
4
Introduction
For 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 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 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.
5
Intended Use
Prior 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.
Contraindications
The 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.
6
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.
7
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.
Scientifically and clinically developed protocols have been preprogrammed 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.
8
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
[email protected]
Note: System parts may appear different than displayed below.
AC Adapter
Power Cable
Controller Unit
Retention
Strap
Treatment Array
Safety Glasses
9
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
10
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
11
Getting Started
Controller Unit
Face
Neck
Shoulder
Upper Back
Elbow
Lower Back
Wrist
Hip
Hand
Knee
Foot
Ankle
Timer
Treatment Stage
Power Stop Start/ Select
Button
Pause Stage
Treatment Array
Strap Anchor Points
Treatment
LEDs
Power LED
Top View of Treatment Array
12
Bottom View of Treatment Array
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 firmly in
place either with the straps provided or manually.
Step 2
Press 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 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 first five 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.
13
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. 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.
Face Pg.16
Neck Pg.22
Shoulder Pg.17
Upper Back Pg.23
Elbow Pg.18
Lower Back Pg.24
14
Wrist Pg.19
Hip Pg.25
Hand Pg.20
Knee Pg.26
Foot Pg.21
Ankle Pg.27
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. 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 Effects
During 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 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.
15
Face
Common Conditions
TMJ Disorder
Placements
Postherpetic Neuralgia
See Figures A and B for the location of the Treatment Array when treating
jaw pain.
A
B
16
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.
A
B
C
17
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.
A
C
18
B
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.
A
B
19
Hand
Common Conditions
Soft Tissue Injuries
Reflex Sympathetic Dystrophy
Arthritis (Degenerative & Rheumatoid
Tendonitis
Ligament and Tendon Tears
Contusions
Placements
See Figures A and B for the location of the Treatment Array when treating
pain in the fingers.
A
B
20
Foot
Common Conditions:
Arthritis (Degenerative & Rheumatoid)
Tendonitis
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.
A
B
C
C
21
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.
22
A
B
C
D
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.
A
B
23
Lower Back
Common Conditions
Arthritis (Degenerative & Rheumatoid)
Rotoscoliosis
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.
24
A
B
C
D
Hip
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.
A
B
C
D
25
Knee
Common Conditions
Ligament and Tendon Tears
Tendonitis
Arthritis(Degenerative & Rheumatoid)
Reflex Sympathetic Dystrophy
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.
26
A
B
C
D
Ankle
Common Conditions
Arthritis (Degenerative & Rheumatoid)
Muscle Strains
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.
A
B
C
D
27
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.
28
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.
29
Issue
No power or
display is blank.
Possible Cause
Solution
Power is not
turned on.
Ensure the cable is
plugged into the
Controller Unit. The
Unit will beep once the
power is connected.
The power supply
is not connected.
System beeps
and displays
an E01 error.
The Treatment Array
is not connected
properly.
System beeps
and displays
an E02 error.
The Treatment Array
is hot (temperature
exceeds 48°C) due
to being covered or
running too long.
System beeps
and displays
an E03 error.
System beeps
and displays
an E04, E05,
E06, E07, E08,
E09, E10, E11
or E12 error.
30
The Teatment Array
cable may have
been removed
unexpectedly.
The temperature
sensor has
malfunctioned.
The system has
malfunctioned.
Plug the power supply
into a wall outlet.
Press the Power button.
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.
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.
Make sure the cable
is properly connected
to the Controller.
If problem persists,
contact BioFlex Service.
Record the error code and
contact BioFlex Service
for further assistance.
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)
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
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. - 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
32
ONE
REVISIONS
REV.
0
1
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
legibly
a 5mmPART
OD cable
TYPE
BF over
APPLIED
Material:
Self
laminating
label
This product is classified as awhite/clear
Type BF Applied
Outline
is for reference
only of protection
Part,
according
to the degree
against
shock.
Labelelectric
must be
UL recgonized, and ROHS
complient
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
Example s/n label (for reference ONLY)
FIED:
m
ND
S/N: 942 0
JOB : 0510524 D
MODEL: SLD+120
This label shows the models and serial numbers
(S/N) of your system’s components.
Serial Number System
05 10 524D-9420-I
NAME
DESIGNED
R.Bramer
SIGN.
DATE
Nov 27 2015
CHECKED
ENG APPR.
Region
S/N
MFG Code
411 Horner Ave., Unit 1, Etobicoke,
ON, Canada M8W4W3
Year
Tel: (416) 251-1055 Fax: (416) 251-2446
Month
DESCRIPTION:
Meditech International Inc.
120 Serial Number Label
MFG APPR.
SIZE
Q.A.
MATERIAL
FIRST ANGLE PROJECTION
AMFER
A
DWG. NO.
SCALE: 1:1
FINISH
FILE:
Y 14.5 M
REV
1
DW103.021
WEIGHT:
SHEET 1 OF 1
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.
3
2
1
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.
GET HOT
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, fire, mechanical and other
specified hazards.
34
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.
35
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
36
Notes
37
Notes
38
Notes
39
415 Horner Ave Unit 12
Tf.1-844-770-0177
Toronto, ON, CAN
[email protected]
M8W 4W3
www.bioflexpersonal.com
A12233
ISO 13485
Meditech International Inc
40

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