BIOFLEX Therapist, Therapist Pro, Home Unit Operation Manual

01

Operation Manual

Therapist, Therapist Pro, Home Unit

THERAPIST

Therapist Operation

Manual

Safety, Installation and Operation

Instructions

Meditech International Inc.

II

Meditech International Inc.

411 Horner Ave. Unit 1
Toronto, Ontario
Canada M8W4W3

Meditech’s EU Authorized Representative:

EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague

The Netherlands
Phone: [phone]
Fax: [phone]

Disclaimer: Meditech International Inc. adheres to recommended
safety standards and proven treatment outcome methodologies. The
company has a comprehensive training program that health care
professionals must follow, in order to properly apply Low Intensity Laser
Therapy (LILT). Meditech International does not support the incorrect
application of LILT.

Copyright © 2014 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.

Published:
1

st

Edition March 2013

2

nd

Edition April 2014

3

rd

Edition October 2014

4

th

Edition March 2015

5

th

Edition June 2015

Therapist Operation Manual DOC 100.652

Email: [email protected]
Web: www.biolexlaser.com

[phone]
(888) 557

-4004

[phone]

Tel:

Fax:

III

Mission Statement

Meditech International Inc.
initiated research in

the

development of Low

Intensity

Laser Therapy

Systems in 1988.

The goal of the company has

been to engineer

devices

that are superior

to those in

existence and

scientifica

lly develop

accurate, effective

protocols

to treat a

variety

of medical

conditions in

the

musculo-

skeletal field.

These include sports injuries
repetitive motion syndrome
and the arthritides.

To date, we have surpassed our

initial goals and expectations
but each day advances our
horizons as the educational
process continues.

Our primary objectives are

to significantly improve/
cure the multiple pathologies
that we encounter in the
shortest possible period of
time. Guidelines to that end
consist of the elimination of
pharmaceuticals and pain and
the restoration of mobility
and quality of life.

IV

Important Safety Instructions

The following safety guidelines protect your system from potential
damage and ensure personal safety:

• The system can be used in any location in the world which
provides the following AC power ratings:

1. 115 volts (V)/60 hertz (Hz) in most of North and South
America and some Far Eastern countries such as Korea
and Taiwan using the MPU30A-1-1 AC adapter, or

2. 100V/50Hz in eastern Japan and 100V/60Hz in
Western Japan using the MPU30A-1-1 AC adapter, or

3. 230V/50Hz in most of Europe, the Middle East, and
the Far East using the MPU30A-1-1 AC adapter.

• AC adapters are available by contacting Meditech or your
local distributor.

• To help prevent electric shock, plug the Controller Unit (CU)
into properly grounded power sources. For best grounding,
plug into a receptacle marked “Hospital Grade.”

• Using extension cords with the system might affect its
performance

• All system cables should be periodically inspected for signs
of deterioration. If damaged, contact Meditech’s authorized
service centers to repair or replace the cable(s).

• Do not pull, kink or pinch the cables. All cables should be
loosely wound in a loop and they should never be tightly
wrapped around the Treatment Array.

• Never remove the ground pin of the AC power cord.

V

• Caution: Use of controls or adjustments or performance of
procedures other than those specified herein may result in
hazardous radiation exposure.

• Be sure nothing rests on your system’s cables and that the
cables are not located where they can be interfered with.

• Only properly trained personnel should use the system.

• Do not spill food or liquids on or in your system.

• Keep system away from radiators and other heat sources.

• If the system is not in use, you should protect it against
unqualified use by activating the key lock in the CU’s Main
Menu screen.

• To reduce the risk of electric shock, do not remove covers from
any part of the system. There are no serviceable parts inside.
Refer servicing to Meditech’s qualified service personnel.

• Wear safety glasses when using the LD-Series Treatment
Heads. Meditech recommends wearing safety glasses for all
Treatment Heads at all times.

• In case of emergency, press the RED “LASER STOP” button

• On the front of the CU to immediately stop the emission of
light radiation and to stop the treatment.

• The LD-Series Treatment Heads should only be used by
qualified personnel. The LD-Series Treatment Heads should
never be provided for patient use.

• The LD-Series Treatment Heads (lasers) should be protected
against unauthorized use by using the ‘System Lock’.

VI

• Some Treatment Arrays require cooling after

use. See the section “Treatment Array Cooling” in
the “LS-Series Treatment Arrays and SLD-Series
Treatment Arrays” section under “System
Features, Indicators and Controls” for information
about Treatment Array cooling.

• Care should be taken when operating the system

as external surfaces of the treatment heads,
controller and power adapter may become hot.

• Before treating, always disconnect the system

from any connection to a computer.

• The system should be installed and operated

according to CAN/ CSA-Z386: 2001 “Laser Safety in
Health Care Facilities.”

• Equipment should not be used adjacent to or

stacked with other equipment and that if
adjacent or stacked use is necessary, the
equipment should be observed to verify normal
operation in the configuration in which it will be
used.

• Equipment must not be disposed of as unsorted

municipal waste, but must be disposed of and
collected separately.

• Although Meditech has taken all reasonable

precautions to ensure system safety, it is also
the responsibility of the therapist to ensure their
personal safety.

• For Contraindications, please refer to the

Clinical User’s Manual.

VII

Rules on Laser Safety (LD-Series)

Lasers of the LD-Series Treatment Heads produce a very intense
beam of light that is potentially hazardous if the direct beam
or specular reflection is viewed by the unprotected eye. The
following precautions should be taken to avoid direct beam
viewing and diffraction. Read the provided “Laser Safety Guide”
from the Laser Institute of America prior to using the system.

• Make certain that your system is located and operated
in a controlled area when using the LD-Series Treatment
Heads. Remove all shiny objects from the area in which
you will be working. This includes rings, watches, metal
bands, tools, and glass. Reflections from the beam can
be nearly as intense as the beam itself.

• The entrances to the area should be posted with the
provided laser danger sign.

• Never look directly into the laser beam or stare
at its reflections. OCULAR DAMAGE CAN OCCUR.

• Never use magnifiers (such as binoculars or
telescopes) to look at the beam.

• Never point the laser at the eyes directly.

• If you are applying the laser to a region of the face,

please ensure that the patient is wearing the safety
eye shields which protect against possible exposure of
the eye to the laser beam.

• Never leave a laser unattended while it is turned on.

• Wear safety glasses! Every person within the enclosed

area must wear safety glasses or eye shields when using
the LD-Series Treatment Head.

• Specific labeling is required on all laser products. For
safety purposes, do not remove any of the labels.

VIII

Important Notice for the LD-Series

Treatment Heads

When applying the Treatment Head, ensure that the entire
nosecone tip (also called “body switch”) has complete contact
with the skin and is not applied at an angle. Failure to do so
will allow potentially harmful laser light to irradiate surrounding
areas.

Correct Application Incorrect Application

Figure 1 LD-Series Treatment Head Application

Safety Glasses Use

FAILURE TO FOLLOW THESE INSTRUCTION MAY

RESULT IN SERIOUS INJURY AND/OR BLINDNESS

READ ALL INSTRUCTIONS AND WARNINGS

BEFORE USING THE SYSTEM

• Never use the safety glasses (or eyewear) with other
manufacturer’s equipment.

• Never use other manufacturer’s safety glasses with the BioFlex
system.

IX

• Always avoid direct eye exposure to direct or reflected
laser light.

• Ensure that the safety glasses it securely at all times.

• Always check safety glasses before use to assure that

they have not become damaged. Exposure to or
contact with chemical vapors or liquids may also cause
surface cracks or other damage. Do not use if you observe
any type of damage to your eyewear and replace your
eyewear immediately.

• Always keep your safety glasses in the Therapist
carrying case when not in use.

• Never use the safety glasses for any purpose other
than for eye protection while using the system.

Cleaning Instructions

Between patient therapy sessions as indicated

• Wash in mild soap and water.

• Rinse in clean water.

• Air dry or pat dry with a clean, soft tissue.

DO NOT USE AMMONIA, ALKALINE CLEANERS,
ABRASIVE CLEANING COMPOUNDS OR

SOLVENTS

WHEN CLEANING SAFETY GLASSES.

CERTAIN SOLVENTS MAY LOWER THE IMPACT
RESISTANCE OF THE LENSES.

X

Safety Kit

The BioFlex Safety Kit consists of the following:

• Laser Safety Guide

• Laser Danger Sign

• Two pairs of safety glasses (one for the practitioner and one
for the patient)

Please read the Laser Safety Guide. Post the danger sign outside
the entrance to the room where the system is located. If

there is

more than one entrance into the room where the system is
located

, please contact Meditech to obtain additional signs

to

post in these areas.

XI

Table of Contents

Important Safety Instructions

Rules on Laser Safety

Safety Glasses Use

Safety Kit

Classification

Safety Standards

Electromagnetic Compatibility (EMC)

Explanation of Warning Symbols and Labels

Controller Unit (CU)

Classification Marks

LD-Series Treatment Head Labels

LS-Series Treatment Head Labels

SLD-Series Treatment Head Labels

DUO

+

Treatment Head Labels

Description of the Beam Delivery Systems

LS-Series Treatment Heads

LD-Series Treatment Heads

iv

vii

viii

x

13

14

15

16

16

16

17

21

25

25

27

27

27

XI

XII

System Features, Indicators and Controls

Controller Unit

LS-Series Treatment Arrays

Applying and Removing Treatment Heads

LS-Series

LD-Series

Operation

Environmental Conditions

Calibration

Cleaning

If the System Becomes Damaged

Guidelines for Proper Packaging

Error Messages

Specifications

Controller Unit

Treatment Heads

Glossary

System Parts List

29

29

34

37

38

39

41

54

55

56

57

58

59

63

63

64

66

67

13

Classification

The system is classified as a medical device. Furthermore, it is in
accordance to the 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 B 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.

14

Safety Standards

This product is classified as medical equipment and has been
tested to comply for the following standards:

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

• 21 CFR 1040 - Performance Standards for Light-Emitting
Products

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

• IEC 60601-2-22:2007 - Medical Electrical Equipment - Part

2: Particular Requirements for the Safety of Diagnostic and

Therapeutic Laser Equipment

• IEC 60825-1 - Safety of Laser Products - Part 1: Equipment
Classification, Requirements and User’s Guide

15

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
Meditech 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.

16

Explanation of Warning Symbols and Labels

This section explains the warning symbols and labels on the
CU and the Treatment Heads. Each Treatment Head has labels
which are located on both sides (underside and topside) of the
Treatment Head.

“Grounding reliability can only be achieved when the
equipment is connected to an equivalent receptacle marked
‘Hospital Grade’.”

Controller Unit (CU)

The CONSULT OPERATION MANUAL symbol.
Parts of the system are marked with this warning
symbol when it is necessary for the user to refer
to the instructions in the Operation Manual.

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

This symbol indicates that the waste of electrical
and electronic equipment must not be disposed
as unsorted municipal waste and must be
collected separately.

Classification Marks

The UL mark is a registered trademark of the
Underwriters Laboratories Inc. with respect
to electric shock, ire, mechanical and other
specified hazards only in accordance with CAN/
CSA C22.2 No. 601.1, CAN/CSA C22.2 No.

601.2.22 and UL 60601-1.

The CE mark is a registered trademark of the
European Community

17

LD- Series Treatment Head Labels

Figure 2 LD-I 75 Treatment Head Explanatory Label

Figure 3 LD-I 200 Treatment Head Explanatory Label

18

Figure 4 LD-R 100 Treatment Head Explanatory Label

“VISIBLE LASER RADIATION” or “INVISIBLE LASER RADIATION”

Laser (LIGHT AMPLIFICATION BY STIMULATED EMISSION OF
RADIATION) is a device which can be made to produce or amplify
electromagnetic radiation in the wavelength range from 180
nm to 1 mm primarily by the process of controlled stimulated
emission. For the LD-series Treatment Heads, the laser light is
radiated from the top of the Treatment Head nosecone tip (see
section “Description of the Beam Delivery System”).

“AVOID EXPOSURE TO BEAM”

Never look directly into the laser beam or stare at its bright
reflections which are radiated from the aperture of the
Treatment Head.

“CLASS 3B LASER PRODUCT”

This “CLASS 3B LASER PRODUCT” emits laser light at a wavelength
where direct beam viewing is hazardous. Avoid viewing diffuse
reflections.

19

For this “CLASS 3B LASER PRODUCT” eye protection is required
and the system has to be operated in an enclosed area where the
entrance should be posted with the provided laser warning sign.

Figure 5 LD-Series Treatment Head Laser Aperture Label

“LASER APERTURE”

This label shows the location of the aperture (LD-series Treatment
Head tip) through which the laser radiation is emitted. Please see

“Description of the Beam Delivery System”.

Figure 6 LD-Series Treatment Head Hazard Symbol

“YELLOW TRIANGLE”

This is a hazard label warning that the system emits hazardous
light. See “CLASS 3B LASER PRODUCT.”
This declaration is required by the U.S. Food and Drug
Administration (FDA) in accordance with the standard 21 CFR
1040 - Performance Standards for Light-Emitting Products.

“This product is in conformity with performance standards for
laser products under 21 CFR 1040, except with respect to those
characteristics authorized by Variance Number 98V0816/7
effective October 7, 1998.”

20

Figure 7 LD-Series Treatment Head Side Label Locations

Figure 8 LD-Series Treatment Head Bottom Label Locations

Date of Manufacture

Refer to the laser treatment head’s serial number label for the
date of manufacture. The format of the serial number is shown
below:

Figure 8a LD-Series Treatment Head Serial Number Format

21

LS-Series Treatment Head Labels

Figure 9 LS-R 250 Treatment Head top label

Figure 10 LS-R 250 Treatment Head bottom label

22

Figure 11 LS-I 500 Treatment Head top label

Figure 12 LS-I 500 Treatment Head bottom label

23

Figure 13 LS-R 750 Treatment Head top label

Figure 14 LS-R 750 Treatment Head bottom label

24

Figure 15 LS-I 1500 Treatment Head top label

Figure 16 LS-I 1500 Treatment Head bottom label

25

Figure 17a DUO+LS-B 3000 Treatment Head top label

Figure 17b DUO

+

LS-B 3000 Treatment Head bottom label. Refer to

Figure 6a for serial number format and date of manufacture

Figure 18 SLD Treatment Head Label

26

“CAUTION: SURFACE MAY BE HOT”

Although Meditech has taken every reasonable precaution to
ensure that the treatment arrays do not become too hot or
uncomfortable for the patient, they still may.

It is the responsibility of the administering practitioner to ensure
the PATIENT’S SAFETY. Prior to starting each treatment, the
patient should be warned that the treatment arrays may become
uncomfortable and that they should notify the administering
practitioner, if they do.

To prevent the treatment array from becoming too warm or
uncomfortable to the patient, it is recommended that the operator
should cool them after 20 minutes of use (e.g. one patient treated
for 20 minutes or four patients treated for 5 minutes each etc.)
by using Meditech’s fan for 2 minutes or 6 minutes at ambient
temperature (without a cooling fan). The above mentioned cooling
procedure applies to protocols with continuous wave mode of
operation at 100% power. With protocols using modulation mode
of operation and/or less power, treatment times can be longer
between cooling periods.

Use caution if very young children or pets are in the patient
environment. It is recommended that the operator should
prevent children from unintentionally touching the treatment
array surfaces because they may not be aware of potential
surface temperatures.

DO NOT cover the treatment arrays during the treatment
because the top surface removes excess heat into the surrounding
environment.

Date of Manufacture

Refer to the “Date:” field on the bottom label of the LS Series
treatment head for the date of manufacture.

27

Description of the Beam Delivery Systems

This section explains how the LS or laser light travels from its
origin to the environment for each Treatment Head.

LS-Series Treatment Heads

(Models: LS-R 250, LS-I 500, LS-R 750, LS-I 1500, SLD-R500,
SLD-I1000 and DUO

+

, DUO)

Light radiates from the LS-Series directly into the environment
(shown in figure below).

Figure 19 LS-Series Treatment Head Light Radiation

Figure 19a SLD-Series Treatment Head Light Radiation

28

LD-Series Treatment Heads

(Models: LD-R 100, LD-I 75, LD-I 200)

Light radiated from the laser diode located inside the Treatment
Head nosecone passes through an air gap. Then, it goes through
a nosecone window (laser aperture) into the environment as
shown in the figure below.

Figure 20 LD-Series Treatment Head Light Radiation

29

System Features, Indicators and Controls

Controller Unit

THERAPIST

EXIT

Figure 21 Front of CU

SELECT

30

To help prevent electric shock, plug the Controller Unit (CU) into
properly grounded power sources. For best grounding, plug into

a

receptacle marked “Hospital Grade.”

Screen

A back-lit liquid crystal display (LCD) provides the user with
information and instructions.

POWER / LASER STOP

• The system is turned on and off by using the POWER / LASER

STOP button on the front of the CU.

• Press once to turn on the system.

• Press POWER / LASER STOP for approximately 1 second to
shut off the system.

• Pressing POWER / LASER STOP during treatment will
immediately stop the treatment and the emission of light.

SELECT and EXIT

Follow the instructions on the bottom of the CU’s screen for when
to use SELECT and EXIT.

UP and DOWN

(Unlabeled Arrow Buttons)

Generally, UP and DOWN allow scrolling through menu items or
selecting values on the CU’s screen. Follow the instructions on
the bottom of the CU’s screen how to use the UP and DOWN
buttons.

31

Figure 22 Back of the CU

Date of Manufacture

Refer to the CU’s serial number label for the date of manufacture.
The format of the serial number is shown below:

32

Figure 22a Serial number format for CU

Stand

The stand can be pulled out to allow the CU to rest at an angle
for easy viewing of the screen.

If detached from the CU, the stand can be re-attached as shown
in the following figure.

Figure 23 Replacing the Stand

33

POWER

INPUT

Figure 24 Top of the CU

Treatment Head Port

(Marked with man symbol)

Any Treatment Head may be plugged into port. Plugs and sockets
are polarized; therefore they must be correctly orientated before
they can lock. Align the mark on the plug with the mark on the
socket.

Power Input

Input for the power adapter. Do not use any other adapter except
the one provided by Meditech or your local distributor. Use of
any other power sources will damage this unit.

USB

This port is used when it is required that the system be connected
with a computer.

DO NOT OPERATE THE UNIT WHILE CONNECTED

TO A COMPUTER.

USB

34

LS-Series & SLD-Series Treatment Arrays

Figure 25 LS Series

Figure 26 DUO Series

Figure 27 SLD Series

35

Treatment Array Cooling

For Models LS-R 250, LS-I 500, LS-R 750, LS-I 1500,
SLD-R 500, SLD-I 1000:

Although Meditech has taken every reasonable

precaution to ensure that the Treatment Heads do not
become too hot or uncomfortable for the patient, they
still may. It is the responsibility of the administering
practitioner to ensure the PATIENT’S SAFETY. Prior to
starting each treatment, the patient should be warned
that the Treatment Heads may become uncomfortable
and that they should

notify the administering

practitioner if they do.

To prevent the treatment arrays from becoming

too warm or uncomfortable to the patient, it is
recommended that the operator should cool them
after 20 minutes of use (e.g. one patient treated for
20 minutes or four patients treated for 5 minutes
each etc.) by using Meditech’s fan for 2 minutes or 6
minutes at ambient temperature (without a cooling
fan). The above mentioned cooling procedure
applies to protocols with continuous wave mode of

operation at 100% power. With protocols using

modulation mode of operation and/or less power,
treatment times can be longer between cooling
periods.

36

For Models DUO (LS-B 2250) and DUO+ (LS-B

3000):

Safety Features

(For Models LS-R 250, LS-R 750, LS-I 500, LS-I 1500)

The LS-Series Treatment Heads are equipped with an “ambient
light sensor” which will prevent the Head from starting if not
secured to the body. If the Treatment Head is not secure, an
error message (see section “Error Messages”) will be displayed
on the LCD. The operator may then proceed with discretion. The
ambient light sensor is designed to measure the amount of
ambient light present in the room prior to invoking a treatment.
If the Treatment Head is securely attached to the patient, the
amount of ambient light reaching the sensor will be minimal. If
the Treatment Head is not secure, the amount of ambient light
reaching the sensor will be significant. Therefore, the amount of
ambient light may vary in different locations.

To prevent the treatment arrays from becoming

too warm or uncomfortable to the patient, it is
recommended that

the operator should cool

them after 40 minutes o

f use (e.g. one

treatment that delivers 20 minutes of red light
followed by 20 minutes of infrared

light) by

using Meditech’s fan for 2 minutes or 6 minutes
at ambient temperature (without a cooling fan).
The above mentioned cooling procedure applies
to protocols with continuous wave mo

de of

operation at 100% power. With protocols using
modulation mode of operation

and/or less

power, treatment times can be longer between
cooling periods.

If the patient finds that Treatment Head is becoming too
warm or uncomfortable, STOP or PAUSE the

treatment, remove the Treatment Head and allow it to
cool until it is cool to the touch. Use CAUTION, if very
young children or pets are being treated. It is
recommended that the operator watch children for
unintentional contact of the Treatment Head surfaces
because they may not be aware of potential surface

temperatures.

37

Applying and Removing Treatment Heads

Method of Disconnecting the Treatment Head:

1. Place your thumb and forefinger around the ribbed connector
and exert moderate pressure of the digits against the CU.

2. At the same time, squeeze the connector.

3. Simultaneously, pull away from the CU to extract the cable.

Figure 28 Disconnecting Treatment Array

38

LS-Series and SLD-Series

The LS-Series Treatment Arrays may be secured directly to the
body using the attached straps.

When applying, place the Treatment Array over the area to be
treated and wrap the straps around the body part. Place the
Velcro from one strap over the Velcro portion of the other strap.

To remove, unlock the Velcro and remove the Treatment Array.

Figure 29 Applying the Treatment Arrays

39

Warnings for Using the Treatment Arrays:

• Do not twist

• Do not hyperextend

• Do not drop

• Do not tamper with diodes

Note: The Treatment Arrays must be secured to
allow air circulation around the top of the head. Do
not cover the heads while running treatments,
however you can use the Meditech approved
weight set.

LD-Series

Body Switch and Indicator

The LD-Series Treatment Heads are activated when the nosecone
tip contacts the skin. After selecting a treatment or continuing
to the next phase, wait until the indicators on the Treatment
Head turn green before applying the Head. Once the indicators
are green, apply the Treatment Head tip to the treatment area
and the treatment will begin (the indicators will turn amber).
Removal from the skin will cease treatment and the indicators
will return to green.

NOTE: When applying the Treatment Head, it is

important to ensure that the flat end makes full
contact with the skin.

Failure to do so might

expose bystanders to potentially dangerous laser

radiation. Refer to the pictures below for the

correct and incorrect application of the Treatment
Head.

A Treatment sleeve MUST always be used for

broken or compromised skin.

40

Correct Application Incorrect Application

Radiation ceases immediately when:

• Contact with the skin ceases.

• Pressing the “UP”, DOWN” or “SELECT” buttons.

• Pressing “LASER STOP” button.

The system is a stand-alone unit.

NOTE: After selecting a treatment or continuing
to the next phase, do NOT touch the tip of the
Treatment Head until the indicators on the head
turn green; otherwise the Treatment Head will not
work. If you do touch the tip before the indicators
turn green, you will have to stop and restart the
treatment to re-activate the Treatment Head.

DO NOT UNPLUG THE TREATMENT HEAD WHILE IT
IS ACTIVE.

DO NOT OPERATE THE UNIT WHILE CONNECTED TO
A COMPUTER.

41

Operation

The following pages show screen shots and describe how to use
the various functions of the BioFlex Therapist System:

Main Screen Menu

From the MAIN MENU you can select to run a treatment, customize a
treatment, adjust the settings of the unit and also lock the unit
from unauthorized use.

This is the main menu when
the system is operating.

Select “Run Treatment” from the

main menu.

Use the

UP/DOWN buttons to scroll to

the Anatomy you are treating
and press

SELECT

42

Scroll:
Select:
Exit:

Scroll:
Select:

Exit:

Scroll:
Select:
Exit:

UP/DOWN

SELECT

EXIT

UP/DOWN

SELECT

EXIT

1 of 9

LS-R750

6min

CW
N/A
N/A

100%

UP/DOWN

SELECT

EXIT

Use the UP/DOWN buttons to scroll to the
Pathology you want to treat and press

SELECT

Use the UP/DOWN buttons to scroll to
the Intensity you want to use and press

SELECT.

Press the

UP/DOWN buttons to view the

Treatment Information. Press the

UP/DOWN buttons to scroll through

the Stages of the Treatment.

Pathology

C-Spine

Intensity

Stage One

Run Treatment

43

LS Arrays

View:
Start:
Exit:

LS Arrays

LS Arrays

DBL CLICK

EXIT

LASER STOP

To start the treatment press SELECT

During this time the Controller performs a
treatment Head Check to test functionality of
the System.

The screen now asks you to place the
treatment head on the area to be treated.
Apply the Treatment Heads as described
in “Applying and Removing the Treatment
Heads” section. Put the safety glasses
provided with your system on and press

SELECT to start the treatment.

UP/DOWN

SELECT

EXIT

Run:
Cancel:
Stop

44

LS Arrays

Pause:
Pause:
Pause:

LS Arrays

PAUSED

DBL CLICK

EXIT

LASER STOP

LS Arrays

SELECT

EXIT

LASER STOP

This screen informs you of the current phase
and time remaining for current phase of the
protocol. The

LASER STOP button can be

pressed at any time during the treatment to
immediately stop the emission of radiation
and cease treatment.

Pressing either of the

UP/DOWN, EXIT or

SELECT buttons will pause the treatment.

To continue the treatment press SELECT. To
cancel treatment, press

EXIT and follow the

on-screen menu. To stop the treatment
press

LASER STOP.

The exit screen.

UP/DOWN

SELECT

EXIT

Run:
Cancel:
Stop:

No:
Exit:
Stop:

45

Step 1 of 3

TH

Time
WaveForm
Frequency

DutyCycle
Power
Run Treatment

Scroll:
Select:
Exit:

Step 1 of 3

TH50

Time
WaveForm
Frequency
DutyCycle
Power

Run Treatment

Scroll:
Select:
Exit:

Pressing SELECT while the step number is
highlighted allows scrolling through the
phases.

To set the Treatment Head (TH), Time,
Waveform, Frequency, Duty Cycle
and Power, highlight the parameter and
press SELECT. The highlighted area will
change (see below).

Customize a Treatment

This section instructs you on how to customize a protocol using
the Therapist CU.

UP/DOWN

SELECT

EXIT

UP/DOWN

SELECT

EXIT

6 min

Squa

5000

90%

100%

TH LS-R750

LS-R750

6 min

Squa

5000

90%

100%

46

Step 1 of 3

LS-R750

Time
WaveForm

Frequency
DutyCycle
Power
Run Treatment

scroll:
select:
exit:

Step 1of 3
TH

Time
WaveForm
Frequency
DutyCycle

Power
Run Treatment

Scroll:
Select:

Exit:

Customize

Step One

Scroll:
Select:
Exit:

To set the specific parameter use the UP/
DOWN buttons to scroll through the options.
When you have found the option you want
to use, press SELECT to initiate change.

To Run the protocol just created plug in
the appropriate head, scroll to Run
Treatment from any phase and press
SELECT.

Treatment will always start from step 1.

During this time the Controller performs a
Treatment Head Check to test functionality
of the System.

Run Treatment

UP/DOWN

SELECT

EXIT

LS-R750

6min

Squa

5000

90%

100%

UP/DOWN

SELECT

EXIT

UP/DOWN

SELECT

EXIT

6min

Squa

5000

90%

100%

TH

47

Customize

Step One

Scroll:
Select:

Exit:

Customize

Step One

Scroll:
Select:

Exit:

Customize

Step One

PAUSED

Scroll:
Select:
Exit:

The screen now asks you to place the
Treatment Head on the area to be treated.
Apply the Treatment Heads as described
in “Applying and Removing the Treatment
Heads” section. Place the safety glasses
provided with your system on and press
SELECT to initiate treatment.

This screen informs you of the current phase
and time remaining for current phase of the
protocol. The LASER STOP button can be
pressed at any time during the treatment to
immediately stop the emission of radiation
and cease treatment.

Pressing either of the UP/DOWN, EXIT or
SELECT buttons will pause the treatment.
To continue the treatment press SELECT. To
cancel treatment, press EXIT and follow the
on-screen menu. To stop the treatment
press LASER STOP.

UP/DOWN

SELECT

EXIT

UP/DOWN

SELECT

EXIT

UP/DOWN

SELECT

EXIT

48

Customize

Step One

SELECT

EXIT

LASER STOP

The exit screen.

No:
Exit:
Stop:

49

Settings

This section describes how to change the various settings.
The settings will be discussed in more detail in the following
illustrations.

Settings

Default Array

Scroll:
Select:
Exit:

System Info

This screen provides the Treatment Head
serial number, firmware version and the
Controller serial number and firmware
version. Press EXIT to go back to the
Settings menu.

Exit:

UP/DOWN

SELECT

EXIT

EXIT

Settings Main Screen

To select an item from the menu, scroll

through the options until the item is

highlighted and press SELECT.

System Info

50

Change:
Select:
Exit:

Adjust:
Select:
Exit:

Update:
Exit:

UP/DOWN

SELECT

EXIT

UP/DOWN

SELECT

EXIT

SELECT

EXIT

Beep Control

The Key Beep can be turned on or off. Key
Beep is the audible beep heard when a
button is pressed. This does not turn off the
beeps heard during treatment. Use the
UP/DOWN buttons to select either Key Beep
ON or Key Beep OFF and press
SELECT.

LCD Contrast

To adjust the contrast of the screen use the
UP/DOWN buttons to adjust the levels of
contrast to the desired level. Press
SELECT to accept or press EXIT to keep
current settings.

Update Firmware

This menu option is used to update the
Controller or Treatment Head firmware if a
new version has been released.

Beep Control

Key Beep ON

LCD Contrast

Update Firmware

51

Scroll:
Select:
Exit:

UP/DOWN

SELECT

EXIT

Lock Password

This option is used to change the Lock
Password. If you change the password write
it down and place it in a safe and secure
location.

Settings

Lock Password

52

System Lock

Settings

Locked

Unlock Unit

-

This screen is displayed when the system is
locked. You must enter a password to unlock
the unit.

To enter the password, use the UP/DOWN
buttons to scroll through the numbers 0-9.
When you have entered the correct number,
press SELECT. The cursor will move to the
next digit. Repeat until you have entered the
password and
Press SELECT.

The system lock is a software lock that password protects the
system from unauthorized use. You should lock the system
when it is not in use. The default lock password is 0000. If you
change the password, write it down and keep it in a safe place.
If you have lost your password contact Meditech or a Meditech
authorized service center for further assistance.

53

Other Screen Shots

You will see the followings screens when the wrong Treatment
Head is plugged into the Controller or if the Treatment Head
becomes unplugged during a treatment.

This screen is displayed when the correct
Treatment Head in not plugged in.

!

Run Treatment

This screen is displayed when the treatment
head is unplugged.

Press SELECT

to
continue with the treatment. Press EXIT to
cancel.

54

Environmental Conditions

The system is capable, while packed for transport or storage, of
being exposed for a period of up to 15 weeks within the following
ranges:

• An ambient temperature range of -20˚C to +70˚C (-4˚F to

+158˚F);

• A relative humidity range of 10% to 100% (non-condensing);

• An atmospheric pressure range of 500hPa to 1,060hPa.

• When the system is operated in accordance with the

instructions for use, the following conditions should not be

exceeded:

• An ambient temperature range of 0˚C to +40˚C (+32˚F to

+104˚F);

• A relative humidity range of 45% to 85% (non-condensing);

• An atmospheric pressure range of 700hPa to 1,060hPa.

55

Calibration

• Calibration of the system and/or its components can only
be performed at Meditech or at an authorized service
center.

• If any LD-Series Treatment Head indicates repeat
errors, it may need calibration.

• To maintain your arrays and to keep them working at
optimal performance, they should be calibrated
periodically, depending on use.

• The Controller Unit (CU) does not require calibration.

Note: Only Meditech authorized service personnel are able
to calibrate the system properly. Unauthorized changes
to the system may be subject to termination of the warranty
at Meditech’s discretion.

WARNING: No modification of this equipment is

allowed. If this equipment is modified, appropriate

inspection and testing must be conducted by

Meditech’s service personnel to ensure continued
safe use of the equipment.

56

Cleaning

• The CU may be cleaned using a damped soft cloth
or a soft disinfectant cloth.

• The arrays may be cleaned with alcohol wipes, a soft
disinfectant cloth, a soft damp cloth and/or alcohol/
cotton swab combinations.

• A soft bristle brush can be used to remove particles
from the LS Series Treatment Array.

• The LD Series Treatment heads may be cleaned with
alcohol wipes a soft disinfectant cloth, a soft damp
cloth and/or alcohol / cotton swab combinations.

• It is recommended that the treatment surface of the
Treatment Arrays be cleaned after each treatment.

• To keep the Treatment Arrays clean from
contaminates from open wounds, etc., use a clear
plastic bag (or plastic wrap) to prevent Treatment
Array contact with the disease area. Treatment
Array Sleeves (covers) can be purchased from
Meditech or a Meditech authorized distributor.

57

If the System Becomes Damaged

If part or all of the system is dropped or damaged, check to
determine if it still functions properly. To troubleshoot a system,
perform the following steps:

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

2. Turn on the CU. If the CU does not work, contact a Meditech
authorized service center for technical assistance.

Liquids from spills or excessive humidity can also damage your
system. If the system becomes wet, perform the following
steps:

1. Immediately unplug all system components from the electrical

outlet.

2. Contact a Meditech authorized service center for assistance.

58

Guidelines for Proper Packaging

In order to ship the system, please follow the guidelines
below for proper packaging:

• Use the original packaging that your system arrived in.

• OR use a box with sufficient room for adequate

cushioning material for all sides of the container.
Never exceed the maximum gross weight for the box
(which is usually printed on the bottom lap).

• Properly cushion the contents of your package by wrapping
each item separately. To prevent damage to the
contents, ensure that they are separated from the corners
and sides of the box. Various materials can be used for
cushioning and protection: i.e. air-encapsulated plastic
(bubble wrap), foam-in-place and/or corrugated dividers.
Use enough cushioning material to ensure that the
contents won’t move easily if the box is handled
improperly.

• Make sure to properly close the box. For best results,
use either pressure-sensitive plastic or water
activated paper tape with at least two inches (5cm) width.
Do not use masking tape, cellophane tape, string or paper
to seal the box.

59

Error Messages

An error message will be displayed on the CU’s screen whenever
there is a problem with the system. All Treatment Heads are
automatically tested prior to each use.

Error Messages

An error message will be displayed on the CU’s screen whenever

there is a problem with the system. All Treatment Heads are
automatically tested prior to each use.

• Should a fault occur within the Treatment Head, the user will be
informed with a “beep” and a message via the LCD.

• In some cases the operator may proceed with discretion.

• If your system requires service, please contact a Meditech

authorized service center.

60

59

Trouble Shooting Guide

MESSAGES VIA LCD

POSSIBLE

CAUSE

SOLUTION

NO POWER or
DISPLAY IS BLANK

Power supply not

connected.

Power not turned on.

Plug power supply into

hospital grade outlet.

Ensure cable is plugged
into the Controller Unit.

Press POWER button.

LOCKED

Press any key to enter

password to unlock.

System is LOCKED to

avoid unauthorized use.

Each stage of a
treatment specifies a

specific Treatment Head.

Plug in Treatment Head

Incorrect or no

Treatment Head
plugged in.

Identify and plug in
specified Treatment

Head.

61

MESSAGES VIA

LCD

POSSIBLE CAUSE

SOLUTION

Head warning

Refer to warning code

L07 in manual

Treatment Head may
be cold compared to
the room temperature
or needs calibration or

is malfunctioning.

All Treatment Heads are

tested prior to each use.

You can still continue to
treat using the Treatment

Head, but use caution.

If this error persists, stop
using the Treatment Head
and send in for service.

Head warning

Refer to warning code

L06, LD8 in manual

Treatment Head may
be hot or needs
calibration or is

malfunctioning.

All treatment heads are

tested prior to each use.
You can

still continue to

treat using the Treatment

Head,

but use extreme

caution.

Ensure that the Treatment

Head is cooled before
continuing in order to
prevent dermal skin

damage. Ask the patient to

inform you if the
Treatment Head
temperature becomes

uncomfor

table or too

warm.

If this error persists, stop
using the Treatment Head
and send in for service.

62

MESSAGES VIA
LCD

POSSIBLE
CAUSE

SOLUTION

Head error
Refer to error code
### in manual

Error codes: L01,

D01, D02, D03, L02,
L03, L04, L09

Treatment Head

may need calibration
or is malfunctioning.

Stop treating with the
Treatment Head.

Contact a Meditech

authorized service center

for further assistance.

Provide error code to the
service center.

Send Treatment Head in

for service.

Head warning

Refer to warning

code ### in manual
Warning codes: L05

Treatment Head

may need calibration
or is malfunctioning.

You may continue
treating with the

Treatment Head

If the problem persists

contact a Meditech
authorized service center

for further assistance.

Provide warning code to

the service center.

System failure
Refer to error code

### in manual

Controller Unit (CU)
or Treatment Head
may need calibration
or is malfunctioning.

Stop treating with the
system.

Contact a Meditech
authorized service center
for further assistance.
Provide error code to the
service center.

Send system in for
service.

Unit failure
Refer to error code
### in manual

Error codes: E01,
E02, E03, E10, E11

and E12

Controller Unit (CU)
is malfunctioning.

Stop treating with the
system.

Contact a Meditech
authorized service center
for further assistance.
Provide error code to the
service center.
Send CU in for service.

63

Specifications

Controller Unit

Function

Specifications

Mode of Operation

Waveform

Duration

Frequency Settings

Duty Cycle

Percent of Total Power

CW, Waveform

Sine, Square and Triangle

1-60 minutes (1 min resolution)

10-100Hz (10Hz resolution)

250, 500, 1000, 2500,

5000 & 10000Hz

10-90% (10% steps)

10-100% (10% steps)

Function

Specifications

Mode of Operation

Waveform

Duration

Frequency Settings

Duty Cycle

Percent of Total Power

CW, Waveform

Sine, Square and Triangle

0-3600 seconds (1 sec resolution)

10-10000Hz (1Hz resolution)

1-100% (1% steps)

1-100% (1% steps)

Table 1 Controller Unit (Customized Protocol)

Table 2 Controller Unit Specifications

64

PARAMETER

UNITS

LD-I 75

LD-I 200

LD-R100

LS-R750

LS-I

1500

Effective laser- LED

class

3B

3B

3B 1 1

Total optical power

mW

75

180

100

750

1500

Effective surface area

cm2

0.10

0.10

0.10

75

75

Power density

mW/cm2

750

1800

750

10

20

Number of devices

1 1 1 179

179

Medium

GaAlAs

GaAlAs

AlGaInP

GaAlAs

GaAlAs

Type

LD

LD

LD

SLD

SLD

Coherence

mm 1 1

N/A 0 0

Wavelength

nm

830

830

660

660

840

Spectral Width

nm

3.0

3.0

N/A

25.0

50.0

Divergence

Deg

9,30

9,30

10,17

8,8

25,25

Device power

mW

75.0

180.0

75.0

4.2

8.5

MPE

18.19W/m2

18.19W/m2

6.36 J/m2 -

Optical density

2.18

2.48

2.03 -

NOHD

cm

0.0

34.3

49.3 -

Table 3 Treatment Head Specifications

Treatment Heads

65

PARAMETER

UNITS

LS-R

250

LS-I

500

LS-B3000

SLD-

R50
0

SLD-

I-

1000

LS-B-2250

Effective laser-

LED class

1 1 1 1 1 1

Total optical

power

mW

250

500

1000(red)

2000(infrared)

500

1000

750(red)

1500 (infrared)

Effective

surface area

cm2

25

25

100

77

77

75

Power density

mW/cm2

10

20

10(red)
20 (infrared)

6.5

13.0

10(red)
20 (infrared)

Number of

devices

59

59

240

120

120

180

Medium

GaAlAs

GaAlAs

AlGaInP (red)

AlGaInP (infrared)

GaAl

As

GaAlAs

AlGaInP (red)

AlGaInP (infrared)

Type SLD

SLD

SLD

SLD

SLD

SLD

Coherence

mm 0 0 0 0 0 0

Wavelength

nm

660

840

660 (red)
840 (infrared)

660

840

660 (red)
840 (infrared)

Spectral Width

nm

25.0

50.0

36 (red)
80 (infrared)

25.0

50.0

36 (red)
80 (infrared)

Divergence

Deg

8,8

25,25

12,12 (red)
12,12 (infrared)

8,8

25,25

12,12 (red)
12,12 (infrared)

Device power

mW

4.2

8.5

4.2 (red)

8.5 (infrared)

4.2

8.5

4.2 (red)

8.5 (infrared)

MPE -

Optical density

W/cm2

-

NOHD

cm -

66

Glossary

LED Light Emitting Diode

SLD Super Luminous Diode

LCD Liquid Crystal Display

LD Laser Diode

CU Controller Unit

EMC Electromagnetic Compatibility

MPE Maximum Permissible Exposure

NOHD Nominal Ocular Hazard Distance

67

Material

Model

Controller Unit

CU

250 mW Red Large Surface Array Treatment Head

LS-R 250

500 mW Infrared Large Surface Array Treatment

Head

LS-I 500
750mW Red Large Surface Array Treatment Head

LS-R 750

1500mW Large Infrared Large Surface Array
Treatment Head

LS-I 1500

1000mW(red)/2000mW(infrared) Large Surface

Array

DUO+ (LS-B 3000)
750 mW(red)/1500mW(infrared) Large Surface

Array

DUO (LS-B 2250)
500mW Red Super Luminous Diode Array

SLD-R 500

1000mW Infrared Super Luminous Diode Array

SLD-I 1000

BioFlex Single Laser LD-I 200

LD-I 200
BioFlex Single Laser LD-I 75

LD-I 75

BioFlex Single Laser LD-R 100

LD-R 100

Carrying Case

BAGT

BioFlex Pro Operational Manual

DOC 100.683

Therapist Clinical Manual

DOC 100.853

Therapist Power supply adapter

CT 100.121

Therapist Power Cord

CT 100.649

Table Fan

CT 100.334
USB Cable

DW 100.650

Treatment Sleeves

CT 100.336

Safety Kit

CT 100.340

Laser safety Guide

Laser Danger Sign

Two Safety Glasses

System Parts List:

The items below might not all be supplied with the
system.

68

69

70

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Phone:[phone] Fax:[phone] Toll Free:[phone]

www.biofl exlaser.com info@biofl exlaser.com

copyright©2014 Meditech International Incorporated. ALL RIGHTS RESERVED

MT-ENG-MN-100652