Operation ManualBioFlex Professional System

BioFlex_Professional_Operation_Manual_Cover.indd 1 11/6/2014 4:39:58 PM

BIOFLEX PROFESSIONAL SYSTEM Operation Manual Safety, Installation and Operation Instructions DOC 100.683 Meditech International Inc. Revision History Edition Comments Date

1 Initial Release October 24 2005 2 Changes for IEC 60601-1 3rd edition March 11, 2013 3 *BETA VERSION* Changes to include the DUO+ LS-B 3000 Treatment Head September 6, 2013 4 Formal release with new DUO+ and software content October 2013 5 Updated with the changes to Practitioner software (version 5.3) September 26, 2014 6 Initial release with DUO LS-B 2250 Treatment Head October 10, 2014

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Meditech International Inc. 411 Horner Ave., Unit 1 Toronto, Ontario Canada M8W 4W3 Tel: (416) 251-1055 Fax: (416) 251-2446 Email: info@bioflexlaser.com Web: www.bioflexlaser.com 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 using the BioFlex Professional System, must follow, in order to properly conduct treatment strategies applying LILT. Meditech International does not support the incorrect application of LILT. Copyright © 2005, 2013, 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 herein are used for identification purposes only and are trademarks or registered trademarks of their respective holders.

Meditech’s EU Authorized Representative:

EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31.70.345.8570 Fax: +31.70.346.7299

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Mission Statement

Meditech’s mission is to develop and market high quality laser therapy systems for healthcare providers and to provide superior training and support to practitioners and therapists so that they may achieve the highest cure rates possible with our products. We believe it is our responsibility to promote the development of LILT and its acceptance by the medical community and the public as the standard modality for treating musclo-skeletal conditions and pain management. We believe the achievement of this goal is in the long-term interests of Meditech, the healthcare system and society.

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Table of Contents

SECTION 1: SAFETY _____________________________________________ 6

IMPORTANT SAFETY INSTRUCTIONS _______________________________ 7

RULES ON LASER SAFETY (LD-SERIES) ______________________________ 9

SAFETY GLASSES USE __________________________________________ 11

TREATMENT ARRAY COOLING ___________________________________ 12

ISOLATION TRANSFORMER SAFETY _______________________________ 12

SYSTEM OPERATION, INDICATORS AND CONTROLS __________________ 13

SAFETY STANDARDS ___________________________________________ 15

ELECTROMAGNETIC COMPATIBILITY (EMC) ________________________ 16

CLASSIFICATION ______________________________________________ 16

EXPLANATION OF WARNING SYMBOLS AND LABELS _________________ 17

SECTION 2: INSTALLATION ______________________________________ 32

INTRODUCTION ______________________________________________ 33

BIOFLEX TREATMENT HEAD HOLDER (THH) AND CABLE ALLEYS ________ 34

PRO FAN ASSEMBLY ___________________________________________ 36

LAYOUT OF THE BIOFLEX PROFESSIONAL SYSTEM ON THE STAND ______ 37

ISOLATION TRANSFORMER INSTALLATION _________________________ 38

POWER BAR INSTALLATION _____________________________________ 39

SYSTEM POWER CONFIGURATION (OUTSIDE THE EUROPEAN UNION) ___ 40

SYSTEM POWER CONFIGURATION (EUROPEAN UNION) ______________ 41

CONNECTING TOGETHER THE BIOFLEX PROFESSIONAL SYSTEM ________ 42

USING THE BIOFLEX PROFESSIONAL SYSTEM WITH A LAPTOP _________ 45

STANDALONE SET UP __________________________________________ 55

SECTION 3: OPERATION ________________________________________ 56

INDICATIONS FOR USE, TREATMENT GUIDELINES, PROTOCOLS & CONTRAINDICATIONS__________________________________________ 57

DESCRIPTION OF THE BEAM DELIVERY SYSTEM _____________________ 58

BIOFLEX PROFESSIONAL MODEL NUMBER SYSTEM __________________ 59

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BIOFLEX PROFESSIONAL CONNECTOR COLOUR SYSTEM ______________ 60

LOCATIONS AND ENVIRONMENTAL CONDITIONS ___________________ 61

DESCRIPTION OF SYSTEM FEATURES ______________________________ 62

APPLYING AND REMOVING OF TREATMENT HEADS _________________ 66

STANDALONE OPERATION ______________________________________ 68

REMOTE OPERATION __________________________________________ 71

QUICK START ________________________________________________ 71

PRESCRIPTION DETAILS ________________________________________ 90

CREATING CUSTOM TREATMENT PROTOCOLS ______________________ 94

TREATMENT CONTROL ________________________________________ 101

NETWORKING THE BIOFLEX PROFESSIONAL SYSTEM ________________ 105

CALIBRATION, MAINTENANCE AND SERVICE ______________________ 113

CLEANING __________________________________________________ 114

IF THE BIOFLEX PROFESSIONAL SYSTEM BECOMES DAMAGED ________ 115

GUIDELINES FOR PROPER PACKAGING ___________________________ 116

ERROR MESSAGES ___________________________________________ 117

SPECIFICATIONS _____________________________________________ 123

SYSTEM PARTS LIST __________________________________________ 126

GLOSSARY __________________________________________________ 127

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SECTION 1: SAFETY

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IMPORTANT SAFETY INSTRUCTIONS The BioFlex Professional System is to be used only by trained health care professionals as part of a comprehensive treatment plan. The following safety guidelines protect your BioFlex Professional System from potential damage and to ensure your own personal safety. For safety instructions for the computer system, please read the manual provided by the computer manufacturer.

• You can use your BioFlex Professional System in any location in the world which provides the following AC power ratings:

− 115 volts (V)/60 hertz (Hz) in most of North and South America and some Far

Eastern countries such as Korea and Taiwan, − 100 V/50 Hz in eastern Japan and 100 V/60 Hz in western Japan, or − 230 V/50 Hz in most of Europe, the Middle East, and the Far East.

However, be sure that your computer and attached devices are electrically rated to operate with the AC power available in your location. Supply cords are available by contacting Meditech International Inc. or your local distributor.

• To help prevent electric shock, plug the Main Controller Unit (MCU) power cable into

properly grounded power sources. For best grounding, plug into a receptacle marked “Hospital Grade.”

• All system cables should be periodically inspected for signs of deterioration. If damaged,

contact Meditech immediately to fix or replace the cable(s). • Never remove the ground pin of the AC power cord.

• Connect only items that have been specified as part of the system. Additional power bars

(or multiple socket-outlet) or extension cords shall not be connected to the system.

• 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 BioFlex Professional System’s cables and that the cables

are not located where they can be stepped on or tripped over. • Do not place food or liquids near or on the BioFlex Professional System. Do not spill

food or liquids on or in your system.

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• Keep your BioFlex Professional System away from radiators and heat sources. Also, do not block cooling vents. Avoid placing loose papers underneath your MCU and computer. Do not place your MCU or computer in a closed-in wall unit or on a bed, sofa, or rug.

• If the BioFlex Professional System is not in use, you should protect it against unqualified

use by removing the key from the key lock from the front of the MCU.

• If moving the cart with the assembled BioFlex Professional System, ensure that all components are positioned safely on the cart to prevent any parts from accidently falling. Do not run the cart over wires or cables. Do not move the cart over thresholds greater than 10mm.

• WARNING: No modification of this equipment is allowed.

• Care should be taken when operating the treatment heads as external surfaces may become hot.

• To reduce the risk of electric shock, do not remove the cover from any part of the system.

There are no serviceable parts inside. Refer servicing to Meditech qualified service personnel.

• The warranty of your BioFlex Professional System will be voided if the “System-Specific

Parameters” are changed by unauthorized persons in the BioFlex Practitioner software.

• Do not run any other applications on the computer system while running the BioFlex Practitioner software.

• Wear safety glasses when using the Treatment Heads of the LD-series (LD-R 100,

LD-I 75, and LD-I 200).

• In case of emergency, press the “Laser Stop” button on the front of the MCU to immediately stop the emission of light radiation and stop treatment.

• A plastic barrier/sleeve MUST always be used for broken or compromised skin.

• Connecting electrical equipment to the Power Bar effectively leads to creating a Medical Electrical System and the result can be a reduced level of safety (refer to IEC 60601-1).

• For Contraindications, please refer to the Clinical Users Manual

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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 a direct beam or specular reflection is viewed by the unprotected eye. The following precautions should be taken to avoid direct beam viewing and to control specular reflections. Read the provided “Laser Safety Guide” from the Laser Institute of America, before using the system.

• Make sure that your BioFlex Professional System is located and operated in a controlled area. The purpose of a controlled area is to confine laser hazards to a well-defined space that is under the control of the laser operator. An example of a controlled area would be a room with a closed door.

• Remove all shiny objects from the area where 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 controlled area should be posted with a provided laser warning sign. • Never look directly into the laser beam or stare at their bright reflections.

PERMANENT EYE DAMAGE COULD RESULT. • Never use magnifiers (such as binoculars or telescopes) to look at the beam. • Never point 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 Heads Specific labeling is required on all laser products. For your safety and that of others, do not remove any of the labels.

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Important Notice for the LD-Series Treatment Heads (LD-R 100, LD-I 75 & LD-I 200): For your own safety, ensure that the entire flat surface of the 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 the surrounding areas.

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SAFETY GLASSES USE

FAILURE TO FOLLOW THESE INSTRUCTIONS MAY RESULT IN SERIOUS INJURY AND/OR BLINDNESS

READ ALL INSTRUCTIONS AND WARNINGS BEFORE USING THE BIOFLEX

PROFESSIONAL SYSTEM • Never use the safety glasses (or eyewear) with other equipment. • Never use other manufacturer’s safety glasses with the system. • Always avoid direct eye exposure to direct or reflected laser light. • Ensure the eyewear fits securely at all times. • Always check your eyewear before use to assure that it has not become pitted, cracked,

crazed, scratched, discoloured or otherwise 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 eyewear in the protective casing provided when not in use. • Never use the safety glasses for any purpose other than for eye protection for the

BioFlex Professional System. Safety Glasses Cleaning Instructions Do not use ammonia, alkaline cleaners, abrasive cleaning compounds or solvents when cleaning the safety glasses. Certain solvents may lower the impact resistance of these lenses. 1. Wash in mild soap and water. 2. Rinse in clean water. 3. Air dry or pat dry with a clean, soft tissue.

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TREATMENT ARRAY COOLING

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. Use caution if very young children 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. For Models LS-R 250, LS-I 500, LS-R 750, LS-I 1500: 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. For Models DUO (LS-B 2250), DUO+ (LS-B 3000): 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 of 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 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.

ISOLATION TRANSFORMER SAFETY Refer to the “Isolation Transformer Installation” section for details.

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SYSTEM OPERATION, INDICATORS AND CONTROLS This section describes the system’s audible and visible warnings for the treatment heads. It also explains how to stop the system in an emergency situation. LS-Series Treatment Heads (Models LS-R 250, LS-R 750, LS-I 500, LS-I 1500, DUO (LS-B 2250), DUO+ (LS-B 3000)) After prescribing a treatment and pressing the “Enable” button in the BioFlex Practitioner software, the green indicator on the topside of the Treatment Head (labeled “Enabled”) turns on and the laser ready indicator beside the port in front of the MCU turns yellow. This indicates that the Treatment Head is ready to use. You can start the treatment after two seconds by double clicking the “Stop/Start” button on the Treatment Head. At the same time you hear an audible two-tone warning “beep” and the yellow “Active” indicator of the Treatment Head turns on, the treatment starts and light is radiated from the SLDs as shown in section “Description of the Beam Delivery System”. The laser ready indicator beside the port of the MCU flashes yellow. Never unplug the Treatment Head if the laser ready indicator beside the port of the MCU is yellow or flashes yellow. (For All LS Models) The light radiation stops immediately:

• after a single click of the Treatment Head’s “Stop/Start” button and at the same time you can hear a double “beep,”

• pressing the “Laser Stop” button in front of the MCU, • pressing the “End Treatment” button in the BioFlex Practitioner software, • pressing the “Pause” button in the BioFlex Practitioner software or • turning the key to the left in front of the MCU.

IN CASE OF AN EMERGENCY, PRESS THE RED PUSH-BUTTON, LABELED “LASER STOP” ON THE FRONT OF THE MCU. THIS STOPS THE EMISSION OF THE LIGHT RADIATION IMMEDIATELY. LD-Series Treatment Heads (Models LD-R 100, LD-I 75, LD-I 200) After prescribing a treatment and pressing the “Enable” button in the BioFlex Practitioner software, the indicator turns green on both sides of the Treatment Head and the laser ready indicator beside the port on the front of the MCU turns yellow. This indicates that the Treatment Head is ready to use. You can start the treatment after two seconds by pressing the entire flat surface of the Treatment Head nosecone tip (also called “body switch”) against the skin without an angle. After you hear an audible two-tone warning “beep” and the indicator of the Treatment Head turns yellow, the treatment starts and light is radiated from the laser diode as shown in

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section “Description of the Beam Delivery System”. The laser ready indicator beside the port of the MCU flashes yellow. NOTE: The LD-series Treatment Heads must not contact the skin until the Treatment Head indicator is green. Never unplug the Treatment Head if the laser ready indicator beside the port of the MCU is yellow or flashes yellow. The light radiation stops immediately,

• after removing the Treatment Head from the skin and at the same time you can hear a double “beep,”

• pressing the “Laser Stop” button in front of the MCU, • pressing the “End Treatment” button in the BioFlex Practitioner software, • pressing the “Pause” button in the BioFlex Practitioner software or • turning the key to the left in front of the MCU.

In case of an emergency, press the red push-button, labeled “Laser Stop,” on the front of the MCU. This stops the emission of the light radiation immediately.

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SAFETY STANDARDS This product is medical equipment and has been tested for compliance with 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

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ELECTROMAGNETIC COMPATIBILITY (EMC) Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and used according to the EMC information provided in the accompanying documents. This system is intended for use by healthcare professionals only. 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. Electrical equipment should not be used adjacent to or stacked with other electrical 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. 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 included use of system cables and connectors between system components. Replace only with Meditech approved cables and connectors.

CLASSIFICATION The BioFlex Professional System is classified as a medical device. Furthermore, in accordance to IEC 60601-1:

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

• TYPE B APPLIED PARTS, according to the degree of protection against electric shock;

• ORDINARY EQUIPMENT, according to the degree of protection against harmful ingress of water;

• CONTINUOUS OPERATION, according to the mode of operation; • NONE OF THE PARTS OR THE SYSTEM IS STERILIZED.

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EXPLANATION OF WARNING SYMBOLS AND LABELS This section explains the warning symbols and labels on the MCU and the Treatment Heads. Each Treatment Head has labels which are located on both sides (underside and topside) of the Treatment Head.

GENERAL SAFETY SYMBOLS

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.

The AC (Alternating Current) symbol is used to indicate the required nature of the line module input power.

The ON symbols are used to mark the “On” position of the instrument power switch.

The OFF symbols are used to mark the “Off” position of the instrument power switch.

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

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CLASSIFICATION MARKS

The UL mark is a registered trademark of the Underwriters Laboratories Inc. with respect to electric shock, fire, 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.

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LD- SERIES Treatment Head LABELS

Figure 2 LD-I 200 Treatment Head Explanatory Label

Figure 3 LD-R 100 Treatment Head Explanatory Label

Figure 1 LD-I 75 Treatment Head

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“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 UNINTENTIONAL EXPOSURE TO BEAM” Never look directly into the laser beam or stare at its bright reflections which is 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. 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 4 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” in subsection “LD-Series Treatment Heads.”

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Figure 5 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 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.” 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.Date of Manufacture Refer to the serial number label on the LD Series and DUO Series treatment heads for the date of manufacture. The format of the serial number is shown below:

Figure 6 LD-Series Treatment Head Serial Number Format

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Figure 7 LD-Series Treatment Head Side Label Locations

Figure 8 LD-Series Treatment Head Bottom Label Locations

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LS-SERIES TREATMENT HEAD (ARRAY) LABELS Figure 9 LS-R 250 Treatment Head top label

Figure 10 LS-R 250 Treatment Head bottom label

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Figure 11 LS-I 500 Treatment Head top label

Figure 12 LS-I 500 Treatment Head bottom label

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Figure 13 LS-R 750 Treatment Head top label

Figure 14 LS-R 750 Treatment Head bottom label

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Figure 15 LS-I 1500 Treatment Head top label

Figure 16 LS-I 1500 Treatment Head bottom label

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

Figure 18 DUO LS-B 2250 Treatment Head top label

Figure 19 DUO Series Treatment Head bottom label. Refer to figure 6 for serial number format and date of manufacturer “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.

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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. Use caution if very young children 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. For Models LS-R 250, LS-I 500, LS-R 750, LS-I 1500: 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. For Model DUO LS-B 2250, DUO+ LS-B 3000: 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 of 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 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.

“VISIBLE LED RADIATION” or “INVISIBLE LED RADIATION” The Treatment Heads use SLDs which are LEDs (LIGHT EMITTING DIODE) and are semiconductor devices to produce electromagnetic radiation by radiative recombination in the semiconductor in the wavelength range from 180 nm to 1 mm. The optical radiation is produced primarily by the process of spontaneous emission, although some stimulated emission may be present. For the LS-series Treatment Heads the light is radiated directly from the SLDs (see section “Description of the Beam Delivery System”). “AVOID UNINTENTIONAL EXPOSURE TO BEAM” Never look directly into the SLD beam or stare at its bright reflections which are directly radiated from the bottom of the Treatment Heads. “CLASS 1 LED PRODUCT”

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This “CLASS 1 LED PRODUCT” emits light at a wavelength that does not, under normal conditions, pose a hazard for your eyes. This is a hazard label warning that the Treatment Head emits potentially hazardous light. See

“CLASS 1 LED PRODUCT.” 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 instruction in the Operation Manual.

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

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MAIN CONTROLLER UNIT LABELS “DANGER Heads Emit Laser Radiation” The Treatment Heads of the LD-Series emits light at a wavelength where direct beam viewing is hazardous. See “CLASS 3B LASER PRODUCT.” Avoid viewing diffuse reflections. Eye protection is required and it has to be operated in an enclosed area where the entrance should be posted with the provided laser warning sign. The Treatment Heads of the LS-Series emits light at a wavelength that do not, under normal conditions, pose a hazard for your eyes. See “CLASS 1 LED PRODUCT.” “CAUTION Authorized Use Only” The BioFlex Professional System should be only operated by authorized personal

The TYPE B APPLIED PART symbol. This product is classified as a Type B Applied Part (see also “Classification”).

Figure 20 Front panel of MCU

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Figure 21 Rear panel of MCU

“FUSE: 5x20mm T 2A 250V” Replace the fuses only with the same type and rating (5x20mm T 2A 250V). The fuses may be accessed with a small screwdriver via the small recess located to the left of the fuse holder DANGER: Disconnect power before replacing fuse “Complies with 21 CFR 1040.10 and 1040.11” This is a certification required by the U.S. Food and Drug Administration (FDA) in accordance with the standard 21 CFR 1040 - Performance Standards for Light-Emitting Products. “Caution: Grounding reliability can be only achieved when equipment is connected to a receptacle marked ‘Hospital Grade’.” To help prevent electric shock, plug the MCU power cable into properly grounded power sources; ideally in a receptacle marked “Hospital Grade.” Date of Manufacture The date of manufacture for the MCU is contained in the MCU’s serial number. The highlighted portion shown below displays where the date of manufacture can be found (i.e. MM – month and YY – year). MCUMMYYXXX-XXX-XXX

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SECTION 2: INSTALLATION

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INTRODUCTION This chapter describes how to install the BioFlex Professional Low Intensity Laser Therapy System (BioFlex Professional System). If you purchased a cart, before you proceed, make sure to assemble the cart according to the cart manufacturer’s assembly instructions.

Attention: During cart assembly, substitute the screws for the vertical leg for both sides of the top shelf with the short screws supplied by Meditech (½” x 10/24 Button Socket Cap Screw).

Figure 22 Holder Shaft in a vertical leg

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BIOFLEX TREATMENT HEAD HOLDER (THH) AND CABLE ALLEYS The following supplied parts are used for the installation of the Treatment Head Holder (THH) and Cable Alleys onto the cart:

Figure 23 Screws. Use with appropriate Figure 24 Provided 1/8” allen key; Allen key 5/32” Allen key is provided by the cart manufacturer.

Figure 25 Cable Alley Figure 26 Velcro 1”×8” Tie and Combined

Velcro Ties

1. Choose a side of the cart in which the Treatment Head Holder Arm (THH-A) will be

placed (left or right side). It is recommended to place the Holder Arm on the opposite side where the patient will be located, so the movable THH is far away from the patient.

2. Remove the small end cap from the top of the cart’s vertical leg by inserting a small flat

head screwdriver into the slot at the bottom of the small end cap and lifting.

3. Insert the Holder Shaft (THH-S) into the open vertical leg with the notch half facing down and towards the inserted screw.

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4. Attach the Holder Plate (THH-P) to the bottom of the Holder Arm and secure it with three of the supplied short screws (½” x 10/24 Button Socket Cap Screw) as shown below in figure 25. Make sure that the texture surface (non-shiny) of the Holder Plate is facing upward and toward the Holder Arm.

Figure 23 Holder Shaft in a vertical leg 5. Slide the Holder Arm over the Holder 6. Shaft (the Holder Plate has to be in a horizontal position).

Figure 29 Cart with Holder Assembly Figure 30 Cart with cable alleys on the back vertical leg

7. Insert the removed small end cap (from step 2) into the end of the Holder Arm. 8. Attach the two Cable Alleys around the centered vertical leg on the back of the cart and

secure it with four long ¾” x 10/24 Self Threading Screws.

9. Once the system has been fully assembled, cables can be organized by threading the cables through the Cable Alleys and securing them with Velcro Ties.

Figure 27 Holder shaft in vertical leg

Figure 28 Holder arm with the holder plate

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10. If moving the cart with the assembled BioFlex Professional System ensure that all

components are positioned safely on the cart to prevent any parts from falling accidently.

PRO FAN ASSEMBLY 1. If the stand and arm are already assembled, remove the outside screw from the Treatment

Head Holder (THH-P). 2. Mount the Right Cover of the PRO FAN to the THH-P at the very end using the 1/8” hex

screw supplied with the THH-P Assembly. 3. Attach the PRO FAN’s Left Cover to the Right Cover using the 4 screws located inside

the PRO FAN housing. Use the screws to attach the cover to the fan housing. 4. Plug the PRO FAN’s AC adaptor into the fan assembly and into the isolation

transformer/power bar supplied by Meditech. 5. Attach the wire for the AC adapter to the stand using the provided Velcro straps.

Figure 31 Assembly of the Pro Fan

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LAYOUT OF THE BIOFLEX PROFESSIONAL SYSTEM ON THE STAND

Figure 32 Cart with Bioflex Professional System

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ISOLATION TRANSFORMER INSTALLATION The purpose of the isolation transformer is to protect the patient and operator from potentially unsafe conditions within the patient environment. An example of a potentially unsafe condition, where the patient might receive a shock, is if the clinic is not properly grounded and the patient comes into contact with both the treatment head and computer. When using the isolation transformer with the BioFlex Professional System, all system components (including the computer, laptop, monitor, MCU, Fan, etc.) shall be plugged into it. The following safety instructions must be followed when using the isolation transformer:

• Plug all system components into the isolation transformer. Do not connect any components to the wall outlet (besides the isolation transformer) as this could cause an electric shock to the patient and/or operator.

• Do not plug in any other devices not part of the BioFlex Professional System into the isolation transformer (i.e. non-system power bars or extension cords). Connecting other devices to the isolation transformer could cause an electric shock to the patient and/or operator.

• Only use the isolation transformer supplied by Meditech with the system. • The isolation transformer shall not be placed on the floor. If your system comes with a

cart, place the isolation transformer on the bottom shelf. • Read the instructions provided by the isolation transformer manufacturer.

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POWER BAR INSTALLATION The system’s computer must stay outside the patient environment (see figure below) when it is plugged into the power bar. This can be done by moving the entire system (including the MCU and Treatment Heads) outside the patient environment and only using the Treatment Heads inside the environment while treating. The following safety instructions must be followed when using the power bar:

• Do not plug the MCU into the power bar. It should be connected to the isolation transformer or a wall outlet

• Do not plug in any other devices not part of the BioFlex Professional System into the power bar. Connecting other devices to the power bar could cause an electric shock to the patient and/or operator.

• Only use the power bar supplied by Meditech with the system. • The power bar shall not be placed on the floor. • Additional power bars or extension cords shall not be connected to the system. • Read the instructions provided by the power bar manufacturer

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System Power Configuration (Outside the European Union)

Wall Outlet

Power Bar

Isolation Transformer

Shuttle Computer

MCU Monitor Fan Power Supply

Fan

Single Professional System Dual Professional System

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System Power Configuration (European Union)

Wall Outlet

Power Bar

Isolation Transformer

Shuttle Computer

MCU Monitor Fan Power Supply

Fan

Single Professional System Dual Professional System

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CONNECTING TOGETHER THE BIOFLEX PROFESSIONAL SYSTEM Refer to section “Power Bar and Isolation Transformer Installation” for instructions to connect power to the system’s devices. Note: Before proceeding, review the manuals provided with the computer, monitor, etc. For a single system:

• Connect the keyboard and mouse to the back of the computer. • Connect the monitor cable from the computer to the monitor. • If using a serial cable, connect the female end to a COM Port at the back of the computer

and the male end to the RS-232 port at the back of the MCU.

Figure 33 MCU RS-232 Port Figure 34 MCU RS-232 Port

Figure 35 COM Port on Computer Figure 36 COM Port on Computer

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• If using an USB-to-serial cable, install the drivers for the cable first. Connect the USB side of the cable to the computer and the 9-pin side to RS-232 Port at the back of the MCU.

For a dual system: The dual system configuration is two computers and two MCUs sharing one keyboard, mouse and monitor. The keyboard, mouse and monitor are shared between the 2 computers by using a KVM switch.

RS-232 Connector

USB Connector

VGA Connector

KVM Switch

KVM Button

Keyboard

Mouse

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Using a KVM switch:

• Do not initially connect the computers to the KVM switch. • Attach the monitor, keyboard, mouse and switch button (if supplied with the KVM

switch) to the KVM base. • Using one set of cables, attach the KVM switch to the first computer. • Power on the first computer and wait until the keyboard and mouse are operational. • Attach the second set of cables from the KVM switch to the second computer. • Click the switch button (if supplied with the KVM switch) or use the keyboard shortcut

keys (refer to the KVM instructions) to switch to the other computer. • Wait until the keyboard and mouse are operational for the second computer. • Connect the serial cables or USB-to-serial cables as described above for the single

system.

The dual system also includes one power bar and one isolation transformer. The extra power bar must be plugged into the isolation transformer. The two computers are placed on top of each other (laying down) on the bottom shelf, with the isolation transformer beside the computers and the power bar placed behind the isolation transformer and computers. All cables should then be run neatly through the cables alleys from bottom to top. The KVM switch box should rest neatly at the top of the cable alley so that keyboard, mouse, monitor, and KVM button can easily be managed. The keyboard and mouse should be on the second shelf and the two MCUs should be on the top shelf with the monitor sitting on top of the MCUs.

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Using the Bioflex Professional System with a Laptop A laptop connected to the system must be certified to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for Medical Electrical Equipment). An ‘USB to serial’ cable is used to connect a laptop to the MCU. A user who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC 60601-1. If necessary, contact your local representative for more information.

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SERIAL PORT SET UP AND USB-TO-SERIAL CABLE INSTALLATION (FOR OPERATING THE SYSTEM USING THE PRACTITIONER SOFTWARE) The BioFlex Professional System is pre-configured before it leaves the factory. If required, the USB-to-Serial cable and COM ports can be manually configured using the following directions. For BioFlex Practitioner version 5.2 and lower, the COM port interface to needs to be set to either COM1, COM2, COM3 or COM4. For BioFlex Practitioner version 5.2.1 and higher, the software can automatically detect the COM port, provided that the Serial Port (in the Config window) is set to “<auto>”, the USB-to-Serial driver software is installed, and the USB-to-Serial cable is plugged in to both computer and MCU. Windows XP

1. Install the USB-to-Serial cable driver software following the instructions provided with the cable.

2. Plug in USB-to-Serial cable to an USB port on your computer. If Windows prompts you for the driver. Select “No, not this time”, and click “Next”. Otherwise, skip to step 4.

3. On next screen, click “Next”. Windows will configure the driver for use.

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4. Click “Finish”.

5. Click “Start” and then right click “My Computer”. In the menu click “Properties”.

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6. Click on “Hardware” and then on “Device Manager”.

7. Click the + icon on left of “Ports (COM & LPT)”, and then double click “USB-to-Serial Comm Port”

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8. Click “Port Settings”, then “Advanced”.

11. Under COM Port number choose COM3, and click OK. If message “This COM name is being used by another device” shows up, click “Yes”.

12. Close all windows and repeat from step 2 for all remaining USB ports on computer.

13. Restart the computer.

Windows 7 1. Install the USB-to-Serial cable driver software following the instructions provided with the

cable.

2. Plug in the USB-to-Serial cable to an USB port on your computer.

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3. Click “Start” and then right click “Computer”. In the menu click “Manage”.

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4. Click on “Device Manager”, then click the triangle icon on left of “Ports (COM & LPT)”,

and then double click “USB-to-Serial Comm Port”. If you do not see the “USB-to-Serial Comm Port”, please wait approximately 1 minute to allow Windows detect and set up the device.

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5. Click “Port Settings”, then “Advanced”.

14. Under COM Port number choose COM3, and click OK. If message “This COM name is being used by another device” shows up, click “Yes”.

15. Close all windows and repeat from step 2 for all remaining USB ports on computer.

16. Restart the computer.

17. The computer is now ready for BioFlex Practitioner software.

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SOFTWARE INSTALLATION (OPERATING THE SYSTEM USING THE PRACTITIONER SOFTWARE) The BioFlex Professional System comes with BioFlex Practitioner software already installed on the computer. If required, the BioFlex Practitioner software can be installed onto a Windows XP or Windows 7 computer using the following directions. SOFTWARE REQUIREMENTS:

• Consult BioFlex® Practitioner release notes for the software and network requirements • The serial port and USB-to-serial cable or serial cable have been set up (see section:

SERIAL PORT SET UP AND USB-TO-SERIAL CABLE INSTALLATION)

Do not uninstall the previous version of the BioFlex® Practitioner software. If you do, you will need to manually copy patient files from the C:\Patients_backup

folder to C:\Bioflex32\Patients folder, change the Patient History Path, Backups, COM port and Colour Scheme. See configuration section for additional information on how to

make these changes.

1. If you have the Practitioner software on a USB stick/drive, insert it to a free USB port on computer, and skip to step 4.

2. If you have the Practitioner software installer on desktop of the computer, skip to step 7. 3. If you downloaded Practitioner software from Meditech’s web site, please skip to step 6. 4. Click Window’s Start button located on the lower left hand corner of the screen and

click Computer (Windows 7) or My Computer (Windows XP). 5. If you have inserted the USB stick/drive, double click the USB drive to open it. Usually it

is located under Devices with removable storage. Sometimes the USB drive may be located under the Hard Disk Drives.

6. Navigate to folder containing the BioFlex® Practitioner installer. BioFlex® Practitioner installer can be named as Bioflex32, Bioflex32us, Bioflex32int, or Bioflex32can.

7. Double-click the installer program to start the installation. 8. If a dialog box pops up and asks if you want to allow an “Unknown publisher to make

changes to your computer”, click Yes. 9. A window will open and display “Welcome to the Bioflex Practitioner Set Up Wizard”.

Click Next. 10. Read the license agreement and if you agree with the license, click I agree. 11. Select any additional treatment heads you would like to have installed (LD-I 75 laser

treatment head, LD-R 100). Unselect the treatment heads which you would not like to have installed ( DUO, DUO+ LD-I 200, LS-R 750, LS-I 1500).

12. Click Install and follow on-screen instructions. 13. Click Finish.

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14. The BioFlex Practitioner software is now installed on the computer. 15. Ensure that the MCU is plugged in, the serial cable or USB-to-Serial cable is attached to

the MCU and the computer and the MCU are turned on (power button is on the rear of the MCU).

16. In Windows desktop, double-click the BioFlex32 icon. 17. If a dialog box appears stating “Could not detect any active COM ports. Change the

COM port through Device Manager and/or plug in the USB-to-Serial cable. Would you like to retry the detection?”, plug in USB-to-Serial cable, wait 1 minute, and click “Yes”. If BioFlex Practitioner shows on screen, the installation is completed.

18. If a dialog box appears stating “selected COM port is either in use by another application or is not supported – Select another COM port”, press “OK”.

19. Press the “CONFIG” button on the top toolbar of the main screen. Under the “Serial Port” window, change the “Professional Unit:” from “<none>” to “<auto>” or “COM3”.

Note: The “<auto>” feature is available only to BioFlex® Practitioner version 5.2.1 and higher.

20. Press the “Accept” button and click “Yes” to the new dialog box to exit the BioFlex program.

21. Restart the BioFlex program. 22. If a dialog box appears stating “selected COM port is either in use by another application

or is not supported – Select another COM port”, press “OK” and change to another COM port choice. (Step 19)

23. BioFlex Practitioner is now configured to communicate with MCU.

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STANDALONE SET UP (OPERATING THE SYSTEM WITHOUT THE PRACTITIONER SOFTWARE) The BioFlex Professional System can be set up for portable use. In this configuration, the MCU is used without a computer. Note: Protocols must be downloaded into the MCU before it is used without the computer. Protocols can be downloaded to the MCU via the Practitioner software. Consult the Operation section for how to download treatments and use the MCU in Standalone configuration.

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3

SECTION 3: OPERATION

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INDICATIONS FOR USE, TREATMENT GUIDELINES, PROTOCOLS & CONTRAINDICATIONS Consult the CLINICAL USER’S MANUAL for the indications for use, treatment guidelines, protocols and contraindications.

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DESCRIPTION OF THE BEAM DELIVERY SYSTEM This section explains how the SLD or laser light travels from its origin to the environment for each Treatment Head of your BioFlex Professional System.

LS-SERIES TREATMENT HEADS (MODELS LS-R 250, LS-R 750, LS-I 500, LS-I 1500,DUO, DUO+) The light is radiated from the SLDs directly into the environment (shown in figure below).

LD-SERIES TREATMENT HEADS (MODELS LD-R 100, LD-I 75, LD-I 200) Laser light is radiated from the laser diode inside the treatment head, passes through the nosecone lens (laser aperture) and into the environment as shown in the figure below.

Figure 37 LS-Series Treatment Head

Figure 38 LD-Series Treatment Head

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BIOFLEX PROFESSIONAL MODEL NUMBER SYSTEM The model number consists of three parts: the first two characters represent the laser device type, the next character (after the dash) represents the light type, and the last characters represent the model number. Laser Device Type Laser Light Type Model Number LD = Laser diode R = Red (visible) LS = Large surface I = Infrared (invisible) B = Red and Infrared

Head ID

Device

Type

Power (mW)

Description

LD-R 100

laser diode

red

75

Point source head, 1 laser diode

LD-I 75

laser diode

infrared

75

Point source head, 1 laser diode

LD-I 200

laser diode

infrared

180

Point source head, 1 laser diode

LS-R 250

large surface

red

250

Small flex head, 60 SLDs

LS-I 500

large surface

infrared

500

Small flex head, 60 SLDs

LS-R 750

large surface

red

750

Large flex head, 180 SLDs

LS-I 1500

large surface

infrared

1500

Large flex head, 180 SLDs

LS-B 3000 large surface

red/ infrared

1000/ 2000

Large flex head, 240 SLDs

LS-B 2250 large surface

red/ infrared

750/ 1500

Large flex head, 180 SLDs

Table 1 Treatment Head identification table

LS I 1500

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BIOFLEX PROFESSIONAL CONNECTOR COLOUR SYSTEM In addition to the “BioFlex Professional Model Number System” each Treatment Head can be identified by the colour of the connector. For example, a black marked connector identifies the LD-I 75 Treatment Head.

• LD-R 100 red • LD-I 75 black • LD-I 200 white (may be black) • LS-R 250 yellow • LS-I 500 green • LS-R 750 orange • LS-I 1500 blue • DUO grey • DUO+ grey

Figure 39 Colored (black) metal connector of a LD-I 75 Treatment Head

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LOCATIONS AND ENVIRONMENTAL CONDITIONS

The BioFlex Professional System should be used indoors. The BioFlex Professional System is capable, while packed for transport or storage, of being exposed to environmental conditions within the following ranges: • An ambient temperature range of -20°C to +50°C (-4°F to +122°F); • A relative humidity range of 10% to 90% (non-condensing); • An atmospheric pressure range of 500 hPa to 1,060 hPa. When the BioFlex Professional System is operated according to the instructions for use, the following conditions should not to be exceeded: • An ambient temperature range of 0°C to +40°C (+32°F to +104°F) for legacy products; • An ambient temperature range of 0°C to +30°C (+32°F to +86°F) for the DUO+ (LS-B

3000); • A relative humidity range of 45% to 85% (non-condensing); • An atmospheric pressure range of 700 hPa to 1,060 hPa.

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DESCRIPTION OF SYSTEM FEATURES

FRONT PANEL

Ports Any Treatment Head may be plugged into any port. Plugs and sockets are polarized, therefore they must be correctly orientated before they will mate.

Data

• a numeric keypad is available to choose a preset treatment displayed on the LCD during “Standalone Operation”

• a continuous bi-directional knob is available to supply the system with data for various functions

Data Access

• cursor keys and an “ENTER” key are available to supply the system with data for various functions

Figure 40 Front panel of the MCU

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Treatment

• three keys are available (START, HOLD, LASER STOP) to implement a treatment

Mode

• two modes of operation (A, B) are available

Lock If the BioFlex Professional System is not in use, you should protect it against unqualified use by removing the key from the key lock from the front of the MCU.

• turn key to the right to enable operation • turn key to the left to “lock” the system • the key can be removed while in “lock” orientation

The system will not function without the key.

LCD

• a backlit liquid crystal display (LCD) consisting of 4 lines X 20 characters provides the user with information

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REAR PANEL

Figure 41 Rear panel of the MCU Note: Some symbols and labels may differ from the above figure. RS-232 Port

• The RS-232 port is intended to be connected to a computer that meets the IEC 60950-1 standard (or equivalent)

• A serial cable or an USB-to-Serial cable can be used to connect the MCU to the computer. An approved USB-to-Serial cable can be purchased from Meditech.

AC Power Module

Power Cord • Use a Meditech supplied power cord to connect the power module to an outlet.

For best grounding, plug into a receptacle marked “Hospital Grade.” Note: unit is equipped with a universal power supply (100-240 VAC 50-60 Hz)

IMPORTANT NOTICE: You must ensure the ground pin or any other pin of the power cord is not broken. Please replace any damaged power cords.

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Power Switch

• power to the unit is controlled with the power switch located directly over the power cord socket

• press I to turn on the MCU • press 0 to turn off the MCU

Feet The feet on the bottom of the MCU can be flipped out to tilt the front in a higher position.

LS-SERIES TREATMENT HEAD AMBIENT LIGHT SENSOR (LS-R 250, LS-I 500, LS-R 750, LS-I 1500) The LS-series Treatment Heads are equipped with an “ambient light sensor” which will warn the operator if the treatment head is not secured to the body. If the treatment head is not secure, a warning message (see section “Error Messages”) will be displayed on the LCD and/or the BioFlex Practitioner software screen. The operator can adjust the head for better contact and proceed with the treatment. The ambient light sensor is designed to warn the user that the treatment head is not properly secured to the patient’s body. This is achieved by measuring 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. Note that the amount of ambient light might vary in different clinical settings.

DUO (LS-B 2250), DUO+ (LS-B 3000), TREATMENT HEAD BI-COLOR LIGHT SOURCE The DUO series is capable of emitting red or infrared light. The system will automatically progress from a red to an infrared step without a pause for a single placement of the treatment head. The system will pause automatically between infrared and red steps to allow for repositioning of the treatment head. If desired, the user can override the automatic pause settings when customizing protocols in the software.

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SAFETY FEATURES LD-Series Treatment Heads The LD-series Treatment Heads are equipped with a “body switch” that will start the laser light only when the tip of the laser treatment head is in direct contact with the skin. The “body switch” was designed to help prevent direct ocular exposure to the laser light.

APPLYING AND REMOVING OF TREATMENT HEADS

LS-Series The LS- and DUO series treatment heads may be secured directly to the body with the attached Velcro Strap. This is done by feeding the strap through the end loop of the treatment head (see figure below) and then mating the Velcro. The Pod is used for removing or positioning the treatment head on the area to be treated. To put on or to remove a Treatment Head from the body, take the Pod with one hand and hold the loop with the other hand. Place the strap around the body part and thread the strap loosely through the loop at the top of the head. Then tighten the strap with the other hand. Make the connection between the Velcro hook and loop of the strap to secure the Head. IMPORTANT: Do not bend the DUO series treatment head beyond its normal curvature as this may break the treatment head.

Note: The LS and DUO series treatment heads must be secured allowing air circulation around the top of the head. It is not recommended to cover the heads while running treatments; however you can use the Meditech approved weight set

Pod SLD

Pod Pockets Loop

Figure 42 LS-Series Treatment Head

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LD-Series The LD-Series Treatment Head is equipped with a “body switch” that will start the laser light only when the tip is in direct contact with the skin without an angle. The head is removed by simply lifting the nosecone tip from the skin. Note: After enabling treatment or continuing from a previous step, wait until the indicators on

the treatment head turn green before applying the head or making contact with the tip or body switch.

For your own safety, ensure that the entire flat surface of the nosecone tip (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 the surrounding areas.

Figure 43 Application of the LD-Series Treatment Head

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STANDALONE OPERATION (OPERATING THE SYSTEM WITHOUT THE PRACTITIONER SOFTWARE) Follow the steps below to operate the BioFlex Professional system without a computer and Practitioner software. Note: Protocols must be downloaded to the MCU before it is used without the computer.

Protocols can be downloaded to the MCU via the Practitioner software. 1. Downloading Treatments/Protocols to the MCU Both Meditech’s default and/or customized protocols can be downloaded to the MCU. Forty different treatments (each treatment can have a different number of steps, but total steps for all treatments can not exceed ninety-nine) may be downloaded for standalone operation. To download protocols, on the Main Screen of the Practitioner software, click on “DOWNLOAD”. Click on “Add Treatment”. Select the desired treatment(s)/protocol(s) from the “Prescribe Treatment” window. The treatment(s) will show up as “Treatments selected for downloading”. Click “Download List” when complete. Explanation of the buttons in the Download window: Add Treatment: Add a new treatment to the list to be downloaded. When adding a treatment, if

an item in column “A” is selected without selecting items from columns “B” and “C”, all the treatments from columns “B” and “C” will be selected too. Likewise, if an item in the “B” column is selected without selecting an item from the “C” column, all of the prescriptions in the “C” column will be selected for download too. Click “Accept” to complete the addition.

Remove Treatment: Delete the selected treatment from the list. Help: Guide on using the “Download Treatments – Professional Unit” window. Download List: Download the current list of treatments to the MCU. Reject: Do not download: Close the window. Clear List: Clear the current list of treatments selected for download. 2. If Locked, Unlock System

If the MCU is locked, unlock the MCU by turning the key to the right. 3. Select Mode A to Run a Treatment

If not already so, place the MCU in MODE A (normal operation) by pressing A. 4. Select a Treatment Protocol

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The protocols downloaded to the MCU are displayed on the MCU’s LCD as PRESET protocols. Choose a preset protocol/treatment by one of the following options: 1) Data knob

• Turn knob clockwise to increment preset number • Turn knob counter-clockwise to decrement preset number

2) Cursor keys • Press arrow keys to increment or decrement preset numbers

3) Numeric keypad • Press two digits in sequence to select preset number • Presets range from 01 to 40

5. Begin Treatment

• Press START to enable treatment and to see which treatment head has to be plugged in (message on LCD will indicate that the head is not plugged in and there will be an audible beep).

• Plug in the appropriate treatment head. NOTE: Head may be plugged in at anytime and may remain connected as required.

• Wait for the laser ready indicator beside the port in front of the MCU to turn yellow and the green indicator on the topside of the head to turn on. The head is now ready to use.

• Start the treatment by double-clicking the “Stop/Start” red button on the treatment head (LS-series). You will hear an audible two-tone warning “beep” and the yellow “Active” indicator of the treatment head turns on. The laser ready indicator beside the port of the MCU flashes yellow. Light is being radiated from the SLDs at this point. The LCD will read ACTIVE.

6. During Treatment

• Treatment may be paused by pressing HOLD on the MCU. The LCD will now read PAUSE. To resume, double-click the “Stop/Start” button on the treatment head (LCD will now read ACTIVE). You can also pause the treatment by single-clicking the “Stop/Start” button while the LCD reads ACTIVE. To resume, double-click the “Stop/Start” button. NOTE: If the treatment contains multiple steps, each step can be paused and resumed.

• Before a step reaches completion: o If the next step of the treatment uses a different treatment head, that treatment head

should be plugged in before the previous step ends. The treatment head for the next step can be plugged into the extra MCU port at any time before the current step ends. (ie. You have a 5 step treatment. 2 LS-R 750’s followed by 2 LD-I 1500’s then ending with the LD-I 75. Before the second LS-R 750 treatment ends, the LS-I 1500 head should be plugged in. Also, the LD-I 75 head should be plugged in before the second LS-I 1500 step ends).

• After a step reaches completion: o The LCD will read PAUSE if the next step uses the same head (and the option to

pause after each step was selected in the BioFlex Practitioner software – see “Remote Operation”). The next step can be started by double-clicking the “Stop/Start” button.

o The next step will automatically begin if the option to pause after each step was not selected in the BioFlex Practitioner software and the same head is used.

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o If the next step uses a different head, the LCD will indicate a message saying the appropriate head is not plugged in. Insert head, wait for the laser ready indicator beside the port of the MCU to turn green and then double-click the “Stop/Start” button on the treatment head.

• Whenever the LCD reads ACTIVE (light is being radiated), the laser ready indicator beside the port on the MCU flashes yellow and the “Active” indicator of the treatment head turns on.

7. Ending the Treatment

• Once the treatment reaches completion, the MCU will sound an audible “beep” and the LCD will state that the final step is over (PAUSE will be displayed on LCD). NOTE: The last step can be continued even after the designated treatment time is over by double-clicking the “Stop/Start” button.

• To disable treatment press STOP on the MCU. NOTE: Always disable treatment upon completion.

8. Viewing Parameters

• To view the specific parameters of a preset, press MODE B followed by ENTER. Use cursor keys or data knob to view each parameter and associated value.

• Press MODE A twice to return to normal operation. • To view each parameter and associated value for a preset treatment with more than one step,

press MODE B and use cursor keys or the data knob to change the step. Press ENTER and use again the cursor keys or the data knob to view the specific parameters.

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REMOTE OPERATION (OPERATING THE SYSTEM USING THE PRACTITIONER SOFTWARE) The MCU may be operated remotely via the RS-232 port and the BioFlex Practitioner software user interface. When using the MCU remotely all front panel functions are disabled with the exception of PORTS, LOCK and LASER STOP. When in remote mode the LCD displays REMOTE.

QUICK START 1. Ensure that the MCU is plugged in, the serial cable or USB-to-Serial cable is attached to the

MCU and the computer and the MCU are turned on (power button is on the rear of the MCU). 2. In Windows desktop, double-click the BioFlex32 icon.

3. If a dialog box appears stating “Could not detect any active COM ports. Please either enable

COM port through Device Manager or plug in the USB-to-Serial cable. Would you like to retry the detection?”, plug in USB-to-Serial cable, wait 1 minute, and click “Yes”.

4. If a dialog box appears stating “selected COM port is either in use by another application or is not supported – Select another COM port”, refer to the installation section for information about proper configuration of the system.

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5. Click “Prescribe Treatment”. Treatments may be selected from the Meditech’s default

protocols, which are organized in three selection categories.

6. If you have selected DUO/ DUO+ array and the LS-R 750 and LS-I 1500 arrays during installation, you can choose which array or arrays your protocol will use.

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7. Click protocol in column A, then B, then C. After the column C selection is highlighted, click

on “Accept” to accept the treatment. See “Help” button for more details.

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8. Plug in the treatment head. Wait for indicator light beside the port in front of the MCU to turn

green. Click on “Enable” to activate the treatment selected.

9. Wait for the green indicator on the head to turn on. The head is now ready to use. Double click on the treatment head button (LS-series) or touch the nosecone tip on skin (LD-series) to start.

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10. Once the treatment head button is pressed twice (LS-series) or the nosecone tip is touched on

skin (LD-series), the treatment begins. The orange bar on the main screen, yellow light on the treatment head and flashing yellow light on the Main Controller Unit, notifies the user that the treatment is running.

• The treatment can be paused by pressing the PAUSE button on the Practitioner software or by pressing the “Stop/Start” button on the LS-series heads or by removing nosecone tip from skin for LD-series heads. To resume, double-click the “Stop/Start” button or press entire flat surface of the nosecone tip against the skin. NOTE: If the treatment contains multiple steps, each step can be paused and resumed.

• After a step reaches completion: o If the next step uses the same head, the treatment will pause. The next step can

be started by double-clicking the “Stop/Start” button (LS-series) or by pressing nosecone tip against the skin (LD-series).

o If the next step uses a different head, the software will indicate a message saying the appropriate head is not plugged in. Insert head, wait for the laser ready indicator beside the port of the MCU to turn green and then start the head.

11. If for some reason you need to shorten or lengthen the treatment by repeating or skipping a

step, you may do so by pressing “Go to next step”, or “Go to previous step”, respectively. These features are only available while paused at the beginning of a step.

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12. Users can customize the current running treatment by selecting “Customize Prescription”.

This feature is only available while paused at the beginning of a step. Note: You cannot customize completed/applied steps.

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13. The software will indicate when the treatment is complete and ask if the user wishes to extend

the treatment. The last step can be repeated any number of times by double-clicking the “Stop/Start” button on the head (LS-series) or by applying the nosecone tip against the skin (LD-series).

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14. The treatment can be stopped at any time by clicking on “End Treatment”. Another treatment

can then be selected.

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Over View of the Practitioner Software

MAIN SCREEN The main screen is divided into four sections:

Top Toolbar Patient Profile Prescription Details Treatment Control

Patient Profile

Prescription Details

Treatment Control

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TOP TOOLBAR There are four different buttons that make up this section of the main screen. The four buttons starting from top left to top right are: Exit, Download, Config and Help.

Exits the program.

Allows downloading of the treatments to the Professional unit for standalone operation. Click on “Add Treatment”. Select the treatment from the “Prescribe Treatment” window. The treatment will then be added to “Treatments selected for downloading”. Forty different treatments (each treatment can have a different number of steps not to exceed ninety-nine in total from all treatments) may be downloaded for standalone operation. Click “Download List” when complete.

Add Treatment: Add a new treatment to the list to be downloaded. Remove Treatment: Delete the selected treatment from the list. Help: Guide on using the “Download Treatments – Professional Unit” window. Download List: Download the current list of treatments to the Professional Unit. Reject – do not download: Close the window. Clear List: Clear the current list of treatments selected for download.

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When adding a treatment, columns “A”, “B” and “C” may be selected for a specific treatment. If only the “A” column is selected, all of the prescriptions in “B” and “C” columns will be selected for download. Likewise, if the “A” and “B” columns are selected, all of the prescriptions in the “C” column will be selected for download. Click “Accept” to complete the addition.

This Help button provides information with regard to the Main Screen, separated into three categories: Patient Profile, Prescription Details and Treatment Control. Click “Next page” to move forward and “Previous page” to move backward.

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The CONFIG button allows the user to set/change the seven configuration options for your system. The seven configuration options that may be set/adjusted are: Serial Port, Printer, Patient Log Comments, Mode, Clinical Trial Password, Patient File Backups and System Specific Parameters. The “Help” button provides information on these six separate parameters. Click on “Next page” to move forward and “Previous page” to move backward.

IMPORTANT: Do not adjust System-Specific Parameters unless notified by Meditech. Adjusting system-specific parameters may cause harm to the system. The “Serial Port” section displays which serial ports BioFlex will use to communicate with the Main Controller Unit. The “Patient File Backups” section allows for election of the times at which the user will be prompted to back up their patient file database. The software will only prompt the user to back up files once per day. The “Patient History Path” section contents the directory path to be used when accessing or saving patient data and customized treatments. The default path is C:\BIOFLEX32\PATIENTS\.

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The “System Specific Parameters”, “Professional Unit” window allows you to change some of the threshold values that are used by the Professional Unit. Please consult with Meditech technical staff before altering these parameters, as incorrect values may cause unpredictable results. Please Note: The Clear Controller Memory button will erase any treatments that are currently stored in the BioFlex Main Controller Unit. Unauthorized changes to the System Specific Parameters may be subject to the immediate termination of warranty (at Meditech’s discretion). The “Main Window” section allows for toggling of the placement clock display. The placement clock is a secondary clock which displays the amount of time remaining before a treatment head must be moved into another position. The “Customization Window” provides access to the advanced mode and DUO / DUO+ settings. If the “Enable advanced mode by default” option is selected then the treatment customization window will display all available treatment parameters. Please note that basic mode is enabled by default and is recommended for simplicity. The “Enable DUO+” option can be deselected to hide all DUO+ features. The “Colour Scheme” section allows for the user to select from two preset color schemes which help identify systems independently. The user may also create a custom colour scheme with the available palette. The “Total Daily Treatment Time” displays the time of all combined treatments per system per day. The clock resets at midnight.

The “About” section describes the software version details.

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PATIENT PROFILE The upper window displays information about the patient currently selected and allows the user to select, add, edit or delete patients, view patient histories or modify the factor that influences the treatment duration for the current patient.

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To add new patients click the “New…” button. The “Help” button will guide the user through the Patient Profile window. Below is the information provided on entering new patients and editing existing patients.

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An existing patient may be selected from a list of patients either by name or by code number. Once a name/code is highlighted, it will appear at the top of the list. It may be accepted by either pressing the "Accept" button, or by double-clicking the name/code. A highlighted patient may also be deleted from the records by pressing the "Delete patient" button. A confirmation must be acknowledged before the deletion occurs, as this will delete all details and history of the patient.

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The “Edit…” button appears on the main screen in the Patient Profile when an existing patient is selected. Click on “Edit” to change existing patient information.

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Click on the “History” button to view prescription and treatment records. If treatments were done with no patient selected, the software will still record the prescriptions and treatments. To view those prescriptions and treatments, clear the patient information, and then click on the “History” button. This feature is only available in BioFlex® Practitioner version 5.3 and higher. Note: To view the history for when no patient was selected on networked systems, please exit the BioFlex® Practitioner software on all slave computers, and then view the history on the master computer. If “Current treatment” is circled, only records corresponding to the selected prescription in the “Prescription Details” section will be viewable. For example, in the picture below, “A” is selected in the Prescription Details section and only “A” treatments are viewable in the “View Patient History” window. If “All treatments” is circled, “A”, “B” and “C” treatments are viewable. View treatment…: View the prescription details of the highlighted treatment. View comment…: View comments on the highlighted record (if available). Print history: Print a hardcopy of the patient’s history. Save protocol: Save the prescribed protocol to custom treatment list (if prescription or treatment is selected). Help: Guide on using the “View Patient History” window. Close: Close the window.

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Removes the current patient from the Patient Profile window.

Three factor categories exist: Age, Complexion, and Build. Each category has three possible choices for selection. Each category's selection represents a multiplier that is used to extend or reduce the duration of a prescribed treatment. Click “Help” button to learn more.

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PRESCRIPTION DETAILS The middle window allows you to select and define up to 3 prescriptions per patient. The following buttons apply only to the currently selected treatment (i.e. A, B or C).

Allows you to select a treatment protocol to run or customize. See sections “Prescribing Treatments” and “Creating Custom Treatment Protocols” for more information.

Allows the user to view the prescription details for the selected treatment. (i.e. Carpal Tunnel, High).

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PRESCRIBING TREATMENTS The A, B and C buttons are used to cycle through the three prescriptions. After selecting from the A, B and C columns, the six buttons to choose from are: “Accept”, “Reject”, “Customize”, “Help”, “Info” and “Head to Use”.

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After a selection is made from the third column, the treatment may be selected with the ACCEPT button, or by double-clicking it in the third column. If the treatment has a tutor file associated with it, the INFO button will be activated. If the treatment is from the user-created library, its name and/or tutor file may be edited or it may be deleted with an EDIT/DELETE button that will appear above the INFO button. After selecting a treatment, the treatment head can be changed using the "Head to Use" list. If a head change is made here, it will affect ALL steps in the treatment. To run a treatment on the Prescription Unit that was originally defined for the Professional Unit, simply change the head to a Prescription Unit model and the treatment will automatically be downloaded to the Prescription Unit after the ACCEPT button is pressed.

The “Reject” button will clear the main screen in order to prescribe another treatment. Click on the “Reject” to exit the “Prescribe Treatment” window.

Click on the “Help” button to learn how to use the Prescribe Treatment window.

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The Create Prescription window allows the user to view and customize protocols for treatment. Example: A: Upper Quadrant, B: Carpal Tunnel, C: High

Click on the “Help” button to learn more about the “Create Prescription” window.

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CREATING CUSTOM TREATMENT PROTOCOLS Note: This section is reserved for practitioners experienced with parameters of operation. Custom treatments can be set up for patients by following the directions below. The “Create Prescription” window (found by pressing buttons Prescribe Treatment Customize…) can be segmented into 7 sections. Each section can be modified. Once the practitioner is satisfied with the modifications, “Accept” should be clicked. The user will then be prompted with a “Create New Treatment” window. Here the user can choose to add the custom treatment to the list of treatments or just use for the current patient (not added to list). The creation of the custom treatment is now complete.

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SECTION 1. PRESCRIPTION DETAILS SECTION 2. STEP DETAILS SECTION 3. PARAMETERS OF OPERATION SECTION 4. WAVEFORM SECTION 5. MODE OF OPERATION SECTION 6. HEAD TYPE SECTION 7. NUMBER OF STEPS CONTROLS Click on the “Help” button to learn more details. Example: Upper Quadrant, Carpal Tunnel, High Create Prescription Window

Section 1

Section 2

Section 3

Section 6

Section 5

Section 4

Section 7

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If the prescription being viewed contains more than one step, an up/down scrollbar will appear to the right of the step number. Pressing this will cycle through the steps and allow viewing the parameters of each step. The "Step is optional" box is checked if the step currently being viewed is optional. Optional steps will be indicated on the main screen when the selected treatment is running. When using the DUO+/DUO, a pause selection box appears above the “Parameters of Operation”. If the box is checked, then the treatment will pause at the end of the step when running and will require a manual restart. Otherwise the treatment will continue to the next DUO+/DUO. This feature allows for the user to treat a given patient in one anatomical area with both red and infrared light before changing anatomical regions. If the next step uses a different head, the "automatic pause" will be checked. Please note: When creating a custom prescription that will use the DUO+/DUO, it is recommended that the user set the number of steps to 2 and create the red and infrared steps for the treatment, respectively. Once these steps have been created, the number of steps may be increased to the desired amount and the software will duplicate the first two steps. This allows for more rapid protocol creation.

Parameters of Operation

The lower left corner of the window contains operational parameters for the current step of the treatment being viewed:

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Average, peak, and percentage power, duration and spot size. Power density is equivalent to average power divided by area. Energy is the product of average power and duration. Energy density is the product of power density and duration. If the mode of operation is MODULATED, frequency and duty cycle parameters appear. If the mode of operation if PULSED, time on and time off parameters appear. If the mode of operation is CONTINUOUS WAVE, the Peak Power, Frequency and Duty Cycle parameter lines will disappear.

Waveform

To the lower right of the parameters of operation is the selection for the waveform when the mode of operation is modulated. There are three waveforms available: - Sine wave - Square wave - Triangle wave To aid in quickly determining which waveform is selected, the icon to the left of the selections will be different depending on which waveform is selected.

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Mode of Operation

To the right of the parameters of operation is the selection for the mode of operation. There are three modes available: - Continuous wave - Modulation - Pulsed To aid in quickly determining which mode is selected, the icon to the left of the selections will change depending on the mode selected. Depending on the current "Mode of Operation", some restrictions apply with regard to available frequencies and duty cycles. See the "Display Mode" help page for more details.

Display Mode

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The "Display Mode" allows you to select alternate ways in which to display Frequency and Duty Cycle parameters. NOTE: Modulation mode is restricted to duty cycle increments of 10% and frequencies in the range of 0.01 to 10,000 Hz. Pulsed mode provides 1 usec resolution in the range of 1-10,000 usec, thus duty cycle is not restricted and frequencies are available in the range from 50 Hz to 500,000 Hz (square wave only).

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The "Head type" box shows the head that is being used for the current step of the treatment by default and can be changed for a head switch.

Head Type

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TREATMENT CONTROL

The enable button will initiate treatment selected from the Prescription Details window on the main screen. Double-click on the treatment head to initiate treatment running.

To put the treatment on hold, click on the “Pause” button or press the button on the treatment head. To resume treatment, double-click on the button on the treatment head.

The “End Treatment” button stops the treatment running. Click on “End Treatment” to prescribe another treatment.

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PATIENT FILE BACKUP/RESTORE NOTE: For networked systems, you must close the software on all other computers before starting the backup or restore of the patient files on the master computer. (See networking section for additional details) To back up the patient files, select the CONFIG button on the top toolbar. There are three options for the Patient File Backups: None, Prompt on Exit and Auto-Prompt.

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NONE No backups will be performed. PROMPT ON EXIT NOTE: Before backing up any patient files, close the Practitioner software on any computers connected to the computer that the backup is being performed from The BioFlex Practitioner software prompts the user for backups on the first exiting of the program daily. Therefore, the program will not ask to perform a backup when the program is exited on the second, third and so forth time in the same day. The BioFlex Practitioner software will ask the user if they wish to back up the patient files when exiting the program. If the user wishes to perform a backup, the user may then click YES. The patient file will then be backed up in a .zip file that is named and saved at the user’s discretion. AUTO-PROMPT The user will only be prompted for a backup once per calendar day, and only if there is a change to the patient history file. RESTORING THE PATIENT FILE BACKUP WARNING: The patient restore procedure overwrites the existing patient files with the ones located in the backup. The patient files backup can be restored by following these instructions. Be sure BioFlex Practitioner software is not running when doing this. Windows XP

1. Using the mouse: left-click on Start. 2. Left-click on My Computer. 3. Navigate the folder that contains the backup file. 4. Double left-click on the backup file to open it. 5. Left-click on Extract all files. 6. Left-click on Next. 7. Using the keyboard: type C:\Bioflex32\Patients. 8. Using the mouse: left-click on Next. 9. When a message pops up asking user to confirm file replace, using the mouse left-click

on Yes to All. 10. Left-click on Show extracted files. 11. Left-click on Finish.

Windows Vista or 7 with Practitioner version 5.2.1 and lower 1. Using the mouse: left-click on Windows logo in the lower left corner of the screen.

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2. Left-click on Computer. 3. Navigate the folder that contains the backup file. 4. Double left-click on the backup file to open it. 5. Left-click on Extract all files. 6. Using the keyboard: type C:\Bioflex32\Patients. 7. Using the mouse: left-click on Show extracted files when complete. 8. Left-click on Extract. 9. When a message pops up asking user to confirm file replace, using the mouse left-click

on Do this for the next N conflicts. 10. Left click on Copy and Replace.

Windows Vista or 7 using Practitioner version 5.3 and higher 1. Start Practitioner software on the master computer. 2. Left-click ‘Config’ button on the top-right corner of the screen. 3. Left-click on ‘Restore from backup’ under ‘Patient File Backups’. 4. Left-click on Yes. 5. Navigate the folder that contains the backup file. 6. Left-click open. 7. Wait until the black window with quick scrolling text disappears from the screen.

The next time the BioFlex Practitioner software is started, the backup data will be accessible.

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NETWORKING THE BIOFLEX PROFESSIONAL SYSTEM For Windows 7 NOTE: ALL MOUSE CLICKS ARE SINGLE LEFT BUTTON CLICKS UNLESS OTHER MENTIONED

Master computer

Click Start

Click ‘Computer’, double click ‘local disk C’, double click ‘Bioflex32’ folder and do right click

on ‘Patients’ folder.

Click on ‘Sharing tab’. (Pic.1)

Pic.1 Folder Properties window

Click on ‘Advanced Sharing’ button. (Pic.2)

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Pic 2. Advanced Sharing Window

Check ‘Share this folder’ Checkbox and click on ‘permissions’ button.

Pic 3. Permissions Window

Make sure checkboxes are checked the same way as on the Pic 3.

Click ‘apply’, ‘Ok’ for all open windows.

Click Start

Click ‘Control Panel’

Find ‘Network and sharing center’ and click on it (Pic. 4) 106

Pic 4. Control Panel Window

Pic 5. Network and sharing center window

Click on ‘Change adapter settings’ on the left tab (pic. 5)

Click on ‘Local Area Connection’ icon, then do a right click and choose ‘properties’

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Pic 6. Network and sharing center window

Click on ‘Internet Protocol Version 4 (Pic. 6)

Pic.7 Internet protocol TCP/IP properties

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Select ‘Use the following IP address’ and enter IP address and subnet mask as on the Pic. 7 (e.g.

IP 192.168.0.2, Mask 255.255.255.0)

Click OK and then Close to confirm the change.

Slave computer

Click Start

Click ‘Control Panel’

Find ‘Network and sharing center’ and click on it (Pic. 8)

Pic 8. Control Panel Window

Pic 9. Network and sharing center window

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Click on ‘Change adapter settings’ on the left tab (pic. 9)

Click on ‘Local Area Connection’ icon, then do a right click and choose ‘properties’

Pic 10. Network and sharing center window

Click on ‘Internet Protocol Version 4 (Pic. 10)

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Pic.11 Internet protocol TCP/IP properties

Select ‘Use the following IP address’ and enter IP address and subnet mask as on the Pic. 11 - IP

192.168.0.3, Mask 255.255.255.0

Click OK and then Close to confirm the change.

Mapping the network folder ‘Patients’

Click on “Start” button. Click on “Computer”. Click “Map network drive” from the top of the

window.

Note the letter name in the ‘Drive’ window and in the ‘Folder’ widow enter the following string

‘\\192.168.0.2\Patients’ as shown on picture 12. Make sure ‘Reconnect at Logon’ Checkbox is

checked. Click ‘Finish’.

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Pic.12 Network Drive mapping window

In case of success you will see new window ‘Patients’ on the screen with information from

master computer.

Run Bioflex Practitioner Software. Click on ‘CONFIG’ button.

Change the path in ‘Patient History Path’ from C:\BIOFLEX32\PATIENTS\ to I:\, as on the

pic.13. Click ‘Accept’.

Click ‘Existing’ button. You should be able to see your patients’ records from the Master

computer.

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CALIBRATION, MAINTENANCE AND SERVICE WARNING : Do not modify this equipment without Meditech’s authorization. If the BioFlex Professional System gives repeated errors it might need calibration. Please contact Meditech or one of its authorized representatives for the calibration service. To ensure that the system runs at optimum performance, it is strongly recommended that the treatment heads are checked annually at a Meditech authorized service centre. Attention: Only Meditech authorized service personnel may calibrate or service the system. Unauthorized changes to the system may be subject to the immediate termination of warranty (at Meditech’s discretion). Unauthorized changes to the “System-Specific Parameters” (found in the BioFlex Practitioner software) will also cause the immediate termination of warranty (at Meditech’s discretion). To reduce the risk of electric shock, do not remove the cover from any part of the system. There are no serviceable parts inside. Refer servicing to a Meditech authorized service centre. All system cables should be periodically inspected for signs of deterioration. If damaged, contact a Meditech authorized service centre immediately to fix or replace the cable(s). On request, Meditech will make available circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist Meditech authorized service personnel to repair the system. Note: System modifications during the actual service life require evaluation to the requirements of IEC 60601-1.

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CLEANING Follow the instructions below to clean your system:

• The MCU may be cleaned using a damp soft cloth or a soft disinfectant cloth. • The LS-series Treatment Heads may be cleaned with alcohol wipes, a soft disinfectant

cloth, a soft damp cloth and/or alcohol – cotton swab combination. • A soft bristle brush can be used to remove particles off the LS-series Treatment Heads. • The LD-series Treatment Heads may be cleaned with alcohol wipes, a soft disinfectant

cloth, a soft damp cloth and/or alcohol - cotton swab combination. • It is recommended that the Treatment Heads be cleaned after each treatment. • To keep the Treatment Heads clean from contaminates due to open wounds, etc., use a

clear plastic barrier / sleeve to prevent Treatment Head contact to the compromised area. Plastic barriers / sleeves (covers) can be purchased from Meditech or a Meditech authorized distributor.

Note:

Do not spray or soak the treatment heads with disinfectants/cleaning solutions, or wrap them with disinfectant-soaked towels. Excessive disinfecting or cleaning solutions can penetrate the equipment housings and will likely cause corrosion of the electronic circuitry causing treatment head failure.

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IF THE BIOFLEX PROFESSIONAL SYSTEM BECOMES DAMAGED If part or all of BioFlex Professional System is dropped or damaged, check it to make sure it still functions properly. To troubleshoot a damaged BioFlex Professional System, perform the following steps:

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

2. Turn on all the components of the system. If the system does not work, contact Meditech

for technical assistance. Liquids from spills, splashes, and excessive humidity can also damage your BioFlex Professional System. If the system becomes wet, perform the following steps:

1. Immediately unplug all system components from the electrical outlet.

2. Contact Meditech authorized service center for assistance. Call toll free: 1-888-557-4004.

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GUIDELINES FOR PROPER PACKAGING If you have to ship the BioFlex Professional System, please follow the guidelines below for proper packaging: • Use a box with large enough room for adequate cushioning material for all sides of the

contents. Never exceed the maximum gross weight for the box (which is usually printed on the bottom flap).

• 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: 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 when you shake the box.

• 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 (5 cm) width. Do not use masking tape, cellophane tape, and string or paper over wrap to seal the box.

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ERROR MESSAGES

• All Treatment Heads are automatically tested prior to each use.

• Should a fault occur within the Treatment Head, the system will “beep” and a message will be shown on the LCD or the BioFlex Practitioner software user interface.

• For messages beginning with “Suspect Head Failure,” the operator should assess

the situation, if safe can proceed with the treatment. If the problem persists, Meditech should be contacted promptly.

• For messages beginning with “Head Failure” the system will prevent further

operation. Discontinue use of the particular Treatment Head and contact Meditech authorized service center.

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Messages via LCD Messages via Practitioner software user interface Description

DEFECTIVE RAM (Location)

− the internal memory is tested each time the unit is turned on

− if found defective, the unit must be serviced by Meditech

− specific address location is shown

SYSTEM LOCKED AUTHORIZED USE ONLY

System is LOCKED Please unlock the BioFlex unit or exit BioFlex Practitioner by clicking on the Exit button below EXIT

− the system may be unlocked via the key on the front panel of the MCU

− when locked, the system is inoperable

BioFlex Central Controller Unit is either locked or absent. Do you wish to continue? (BioFlex Central Controller Unit features will not be available) OK CANCEL

− the system may be unlocked via the key on the front panel of the MCU

− the MCU may not be turned ON − the MCU may not be connected to

the computer via the RS-232 cable − the BioFlex Practitioner software

may be set for the incorrect COM port, check CONFIG

− the computer may not be configured properly

− the MCU, connections and associated configuration must be in place prior to running the BioFlex Practitioner software

− the BioFlex Practitioner software will function without the presence of the MCU, however, the MCU specific functions will not be available

Could not detect any active COM ports. Please either enable COM port through Device Manager or plug in the USB-to-Serial cable. Would you like to retry the detection? YES NO

− USB-to-Serial cable may not be plugged in

− USB-to-Serial driver may not be installed

− COM and/or USB port may not be enabled. Enable through Device Manager

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Messages via LCD

Messages via Practitioner software user interface Description

HEAD NOT

HEAD MUST BE PLUGGED IN

− each step of a treatment specifies a specific Treatment Head

− any Treatment Head may be plugged into any MCU PORTS

− identify and plug in specified Treatment Head

WARNING: HEAD MAY NOT BE SECURE PROCEED WITH CAUTION?

WARNING: HEAD MAY NOT BE SECURE. PROCEED WITH DISCRETION? YES NO

− message is specific to LS series Treatment Heads − Treatment Head is tested prior to each use − The Treatment Head may not be securely attached

to the patient

− once alerted, the user may continue − contact Meditech if the error occurs on a regular

basis

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Messages via LCD Messages via Practitioner software user interface

Description

SUSPECT HEAD FAILURE (TOO COLD) IF PROBLEM PERSISTS CONTACT MEDITECH

SUSPECT HEAD FAILURE (TOO COLD). IF PROBLEM PERSISTS, CONTACT MEDITECH. PROCEED WITH DISCRETION? YES NO

− all Treatment Heads are tested prior to each use

− the Treatment Head may be too cold. Allow Treatment Head to warm to room temperature

− the SLD array or Laser Diode may be damaged

− the Treatment Head may require calibration

− once alerted, the user may continue

− contact Meditech if the error occurs on a regular basis

SUSPECT HEAD FAILURE (TOO HOT) IF PROBLEM PERSISTS CONTACT MEDITECH

SUSPECT HEAD FAILURE (TOO HOT). IF PROBLEM PERSISTS, CONTACT MEDITECH. PROCEED WITH DISCRETION? YES NO

− all Treatment Heads are tested prior to each use

− the Treatment Head may be too hot, cool Treatment Head

− the SLD array or Laser Diode may be damaged

− the Treatment Head may require calibration

− once alerted, after verifying that the temperature of the Treatment Head poses no danger to the patient, the user may continue with the treatment

− contact Meditech if the error occurs on a regular basis

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Messages via LCD Messages via Practitioner software user interface Description

SUSPECT HEAD FAILURE (MONITOR) IF PROBLEM PERSISTS CONTACT MEDITECH

SUSPECT HEAD FAILURE (MONITOR). IF PROBLEM PERSISTS, CONTACT MEDITECH. PROCEED WITH DISCRETION? YES NO

− all Treatment Heads are tested prior to each use

− the SLD array or Laser Diode may be damaged

− the Treatment Head may require calibration

− once alerted, the user may continue − contact Meditech for assessment

HEAD FAILURE (OVERLOAD) CONTACT MEDITECH DISCONTINUE USE

TREATMENT HEAD FAILURE (OVERLOAD) CONTACT MEDITECH DISCONTINUE USE OK

− message is specific to LD series Treatment Heads

− once alerted, DO NOT continue, STOP or END TREATMENT

− contact Meditech for assessment

HEAD FAILURE (+VOLTAGE) CONTACT MEDITECH DISCONTINUE USE

TREATMENT HEAD FAILURE (+VOLTAGE) CONTACT MEDITECH DISCONTINUE USE OK

− message is specific to LD series Treatment Heads

− once alerted, DO NOT continue, STOP or END TREATMENT

− contact Meditech for assessment

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Messages via LCD Messages via Practitioner software user interface Description

HEAD FAILURE (-VOLTAGE) CONTACT MEDITECH DISCONTINUE USE

TREATMENT HEAD FAILURE (-VOLTAGE) CONTACT MEDITECH DISCONTINUE USE OK

− message is specific to LD series Treatment Heads

− once alerted, DO NOT continue, STOP or END TREATMENT

− contact Meditech for assessment

HEAD FAILURE (INPUT) CONTACT MEDITECH DISCONTINUE USE

TREATMENT HEAD FAILURE (INPUT) CONTACT MEDITECH DISCONTINUE USE OK

− once alerted, DO NOT continue, STOP or END TREATMENT

− contact Meditech for assessment

HEAD FAILURE (OPTICAL) CONTACT MEDITECH DISCONTINUE USE

TREATMENT HEAD FAILURE (OPTICAL) CONTACT MEDITECH DISCONTINUE USE OK

− once alerted, DO NOT continue, STOP or END TREATMENT

− contact Meditech for assessment

HEAD FAILURE (POWER) CONTACT MEDITECH DISCONTINUE USE

TREATMENT HEAD FAILURE (POWER) CONTACT MEDITECH DISCONTINUE USE OK

− once alerted, DO NOT continue, STOP or END TREATMENT

− contact Meditech for assessment

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SPECIFICATIONS

MAIN CONTROLLER UNIT Function

Specification

Mode of operation

CW, Modulation, Pulsed

Waveform

sine, square, triangle

Percent of total power

0-100% (1% steps)

Duration

0-3600 seconds (60:00 minutes)

Frequency (modulation mode)

0.01-10,000 Hz (5 µs resolution)

Duty Cycle

10-90% (10% steps) (5 µs resolution)

Ton (pulsed mode)

1-10,000 µs (1 µs resolution)

Toff (pulsed mode)

1-10,000 µs (1 µs resolution)

Number of steps

1-24

Table 2 Main Controller Unit specifications

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TREATMENT HEADS LD Series Treatment Heads Parameter

Units

LD-R 100

LD-I 75

LD-I 200

Effective laser - LED class

3B

3B

3B

Total optical power

mW

75

75

180

Effective surface area

cm2

0.10

0.10

0.10

Power density

mW/cm2

750.0

750.0

1800.0

Source types

1

1

1

Number of devices

1

1

1

Medium

AlGalnP

GaAlAs

GaAlAs

Type

LD

LD

LD

Coherence

mm

Not Available

1

1

Wavelength

nm

660

830

830

Spectral width

nm

Not Available

3

3

Divergence

Deg

10,17

9,30

9,30

Device power

mW

75.0

75.0

180.0

Maximum Permissible Exposure (MPE)

6.36 J/m2

18.19 W/m2

18.19 W/m2

Optical Density (OD) 2.03 2.18 2.48 NOHD cm 49.3 0.0 34.3

Table 3 LD Series Treatment Heads Specifications

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LS Series Treatment Heads Parameter

Units

LS-R 250

LS-I 500

LS-R 750

LS-I 1500

LS-B 3000

LS-B 2250

Effective laser - LED class

1

1

1

1

1

1

Total optical power

mW

250

500

750

1500

1000 (red) 2000 (infrared)

750 (red) 1500 (infrared)

Effective surface area

cm2

25

25

75

75

100

75

Power density

mW/cm2

10.0

20.0

10.0

20.0

10.0 (red) 20.0 (infrared)

10.0 (red) 20.0 (infrared)

Source types

1

1

1

1

1

1

Number of devices

59

59

179

179

240

180

Medium

GaAlAs

GaAlAs

GaAlAs

GaAlAs

AlGaInP (red) AlGaAs (infrared)

AlGaInP (red) AlGaAs (infrared)

Type

SLD

SLD

SLD

SLD

SLD

SLD

Coherence

mm

0

0

0

0

0

0

Wavelength

nm

660

840

660

840

660 (red) 840 (infrared)

660 (red) 840 (infrared)

Spectral width

nm

25.0

50.0

25.0

50.0

36 (red) 80 (infrared)

36 (red) 80 (infrared)

Divergence

Deg

8,8

25,25

8,8

25,25

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

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

Device power

mW

4.2

8.5

4.2

8.5

4.2 (red) 8.5 (infrared)

4.2 (red) 8.5 (infrared)

Table 4 LS Series Treatment Heads Specifications

125

SYSTEM PARTS LIST Depending on the system configuration, your system will contain some/all of the following: Item Model Notes Main Controller Unit MCU 180mW Infrared Laser Diode Treatment Head

LD-I 200

75mW Infrared Laser Diode Treatment Head

LD-I 75

75mW Red Laser Diode Treatment Head

LD-R 100

250mW Red Large Surface Array Treatment Head

LS-R 250

500mW Infrared Large Surface Array Treatment Head

LS-I 500

750mW Red Large Surface Array Treatment Head

LS-R 750

1500mW Infrared Large Surface Array Treatment Head

LS-I 1500

750mW(red)/ 1500mW(infrared) Large Surface Array Treatment Head

DUO (LS-B 2250)

Note: Treatment Heat only Available in North America

1000mW(red)/2000mW(infrared) Large Surface Array Treatment Head

DUO+ (LS-B 3000)

Note: Treatment Head only available in North America

Treatment Head Holder

THH Holder Arm, Holder Shaft, Alan Key-1/8”, Screws- 10/24, Holder Plate

Computer

IEC 60950-1, Monitor, Keyboard, Mouse, Bioflex Logo Sticker

Pro Fan Kit

Pro Fan Power adaptor

Anthro Cart PCO3 Black (BK)

Anthro Cart Casters CT 100.675 (EU only) Safety Kit SAFEKIT • 2 pairs safety glasses

• Laser safety guide • Laser Danger Sign

User Manuals • Clinical User Manual • Operation Manual

Practitioner Software DSKPRAC Power Bar Cable Management Kit CMK Isolation Transformer Serial Cable Plastic Sleeves BioFlex Bag BAGBF Weight Set Long Extension Strap Eye Shields

126

GLOSSARY LED: Light Emitting Diode SLD: Super Luminous Diode (Very bright LED) LCD: Liquid Crystal Display LS: Large Surface LD: Laser Diode MCU: Main Controller Unit EMC: Electromagnetic Compatibility MPE: Maximum Permissible Exposure NOHD: Nominal Ocular Hazard Distance

127

415 Horner Ave. Toronto Ontario, M8W 4W3Phone:(416)251-1055 Fax:(416)251-2446 Toll Free:(888)557-4004

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

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