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BIOFLEX Therapist Operation Manual

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Operation Manual
Therapist, Therapist Pro, Home Unit
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Summary of Contents for BIOFLEX Therapist

  • Page 1 Operation Manual Therapist, Therapist Pro, Home Unit...
  • Page 2 THERAPIST Therapist Operation Manual Safety, Installation and Operation Instructions Meditech International Inc.
  • Page 3 All brand and product names mentioned are used for identification purposes only and are trademarks or registered trademarks of their respective holders. Published: Edition March 2013 Edition April 2014 Edition October 2014 Edition March 2015 Edition June 2015 Therapist Operation Manual DOC 100.652...
  • Page 4 Mission Statement Meditech International Inc. initiated research development Intensity Laser Therapy Systems in 1988. The goal of the company has be en enginee r de vice s that are superior to those in existence and scientifically develop accurate, effective protocols treat variety medical...

  • Page 5: Important Safety Instructions

    Important Safety Instructions The following safety guidelines protect your system from potential damage and ensure personal safety: • The system can be used in any location in the world which provides the following AC power ratings: 1. 115 volts (V)/60 hertz (Hz) in most of North and South America and some Far Eastern countries such as Korea and Taiwan using the MPU30A-1-1 AC adapter, or 2.
  • Page 6 • Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. • Be sure nothing rests on your system’s cables and that the cables are not located where they can be interfered with. •...
  • Page 7 • municipal waste, but must be disposed of and collected separately. Although Meditech has taken all reasonable • precautions to ensure system safety, it is also the responsibility of the therapist to ensure their personal safety. Contraindications, please refer •...
  • Page 8 Rules on Laser Safety (LD-Series) Lasers of the LD-Series Treatment Heads produce a very intense beam of light that is potentially hazardous if the direct beam or specular reflection is viewed by the unprotected eye. The following precautions should be taken to avoid direct beam viewing and diffraction.

  • Page 9: Safety Glasses Use

    RESULT IN SERIOUS INJURY AND/OR BLINDNESS READ ALL INSTRUCTIONS AND WARNINGS BEFORE USING THE SYSTEM • Never use the safety glasses (or eyewear) with other manufacturer’s equipment. • Never use other manufacturer’s safety glasses with the BioFlex system. VIII VIII...
  • Page 10 Do not use if you observe any type of damage to your eyewear and replace your eyewear immediately. Always keep your safety glasses in the Therapist • carrying case when not in use. Never use the safety glasses for any purpose other •...

  • Page 11: Safety Kit

    Safety Kit The BioFlex Safety Kit consists of the following: • Laser Safety Guide • Laser Danger Sign • Two pairs of safety glasses (one for the practitioner and one for the patient) Please read the Laser Safety Guide. Post the danger sign outside the entrance to the room where the system is located.

  • Page 12: Table Of Contents

    Table of Contents Important Safety Instructions Rules on Laser Safety Safety Glasses Use viii Safety Kit Classification Safety Standards Electromagnetic Compatibility (EMC) Explanation of Warning Symbols and Labels Controller Unit (CU) Classification Marks LD-Series Treatment Head Labels LS-Series Treatment Head Labels SLD-Series Treatment Head Labels Treatment Head Labels Description of the Beam Delivery Systems...
  • Page 13 System Features, Indicators and Controls Controller Unit LS-Series Treatment Arrays Applying and Removing Treatment Heads LS-Series LD-Series Operation Environmental Conditions Calibration Cleaning If the System Becomes Damaged Guidelines for Proper Packaging Error Messages Specifications Controller Unit Treatment Heads Glossary System Parts List...

  • Page 14: Classification

    Classification The system is classified as a medical device. Furthermore, it is in accordance to the Sub-clause 6 of IEC 60601-1 and Clause 6 of IEC 60601-1:2005: • CLASS I EQUIPMENT, according to the type of protection against electric shock; •...

  • Page 15: Safety Standards

    Safety Standards This product is classified as medical equipment and has been tested to comply for the following standards: Canadian standards • CAN/CSA C22.2 No. 60601.1, Third ed. - Medical Electrical Equipment - Part 1: General Requirements for Safety • CAN/CSA C22.2 No. 601-1.M90 - Medical Electrical Equipment –...

  • Page 16: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) This equipment complies with the European rules for EMC according to the safety standard IEC 60601-1-2. This device complies with EMC rules under test conditions that include use of system cables and connectors between system components. This Equipment requires special precaution regarding the EMC and must be installed and put into service according to the information provided in this manual.

  • Page 17: Explanation Of Warning Symbols And Labels

    Explanation of Warning Symbols and Labels This section explains the warning symbols and labels on the CU and the Treatment Heads. Each Treatment Head has labels which are located on both sides (underside and topside) of the Treatment Head. “Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked ‘Hospital Grade’.”...

  • Page 18: Ld-Series Treatment Head Labels

    LD- Series Treatment Head Labels Figure 2 LD-I 75 Treatment Head Explanatory Label Figure 3 LD-I 200 Treatment Head Explanatory Label...
  • Page 19 Figure 4 LD-R 100 Treatment Head Explanatory Label “VISIBLE LASER RADIATION” or “INVISIBLE LASER RADIATION” Laser (LIGHT AMPLIFICATION BY STIMULATED EMISSION OF RADIATION) is a device which can be made to produce or amplify electromagnetic radiation in the wavelength range from 180 nm to 1 mm primarily by the process of controlled stimulated emission.
  • Page 20 For this “CLASS 3B LASER PRODUCT” eye protection is required and the system has to be operated in an enclosed area where the entrance should be posted with the provided laser warning sign. Figure 5 LD-Series Treatment Head Laser Aperture Label “LASER APERTURE”...
  • Page 21 Figure 7 LD-Series Treatment Head Side Label Locations Figure 8 LD-Series Treatment Head Bottom Label Locations Date of Manufacture Refer to the laser treatment head’s serial number label for the date of manufacture. The format of the serial number is shown below: Figure 8a LD-Series Treatment Head Serial Number Format...

  • Page 22: Ls-Series Treatment Head Labels

    LS-Series Treatment Head Labels Figure 9 LS-R 250 Treatment Head top label Figure 10 LS-R 250 Treatment Head bottom label...
  • Page 23 Figure 11 LS-I 500 Treatment Head top label Figure 12 LS-I 500 Treatment Head bottom label...
  • Page 24 Figure 13 LS-R 750 Treatment Head top label Figure 14 LS-R 750 Treatment Head bottom label...
  • Page 25 Figure 15 LS-I 1500 Treatment Head top label Figure 16 LS-I 1500 Treatment Head bottom label...

  • Page 26: Sld-Series Treatment Head Labels

    Figure 17a DUO LS-B 3000 Treatment Head top label Figure 17b DUO LS-B 3000 Treatment Head bottom label. Refer to Figure 6a for serial number format and date of manufacture Figure 18 SLD Treatment Head Label...
  • Page 27 “CAUTION: SURFACE MAY BE HOT” Although Meditech has taken every reasonable precaution to ensure that the treatment arrays do not become too hot or uncomfortable for the patient, they still may. It is the responsibility of the administering practitioner to ensure the PATIENT’S SAFETY.

  • Page 28: Duo

    Description of the Beam Delivery Systems This section explains how the LS or laser light travels from its origin to the environment for each Treatment Head. LS-Series Treatment Heads (Models: LS-R 250, LS-I 500, LS-R 750, LS-I 1500, SLD-R500, SLD-I1000 and DUO , DUO) Light radiates from the LS-Series directly into the environment (shown in figure below).
  • Page 29 LD-Series Treatment Heads (Models: LD-R 100, LD-I 75, LD-I 200) Light radiated from the laser diode located inside the Treatment Head nosecone passes through an air gap. Then, it goes through a nosecone window (laser aperture) into the environment as shown in the figure below.

  • Page 30: System Features, Indicators And Controls

    System Features, Indicators and Controls Controller Unit THERAPIST EXIT SELECT Figure 21 Front of CU...
  • Page 31 To help prevent electric shock, plug the Controller Unit (CU) into properly grounded power sources. For best grounding, plug into a receptacle marked “Hospital Grade.” Screen A back-lit liquid crystal display (LCD) provides the user with information and instructions. POWER / LASER STOP •...
  • Page 32 Figure 22 Back of the CU Date of Manufacture Refer to the CU’s serial number label for the date of manufacture. The format of the serial number is shown below:...
  • Page 33 Figure 22a Serial number format for CU Stand The stand can be pulled out to allow the CU to rest at an angle for easy viewing of the screen. If detached from the CU, the stand can be re-attached as shown in the following figure.
  • Page 34 POWER INPUT Figure 24 Top of the CU Treatment Head Port (Marked with man symbol) Any Treatment Head may be plugged into port. Plugs and sockets are polarized; therefore they must be correctly orientated before they can lock. Align the mark on the plug with the mark on the socket.

  • Page 35: Ls-Series Treatment Arrays

    LS-Series & SLD-Series Treatment Arrays Figure 25 LS Series Figure 26 DUO Series Figure 27 SLD Series...
  • Page 36 Treatment Array Cooling Although Meditech taken every reasonable precaution to ensure that the Treatment Heads do not become too hot or uncomfortable for the patient, they still may. It is the responsibility of the administering practitioner to ensure the PATIENT’S SAFETY. Prior to starting each treatment, the patient should be warned that the Treatment Heads may become uncomfortable that...
  • Page 37 For Models DUO (LS-B 2250) and DUO+ (LS-B 3000): To prevent the treatment arrays from becoming too warm or uncomfortable to the patient, it is recommended that operator should cool them after minutes (e.g. 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).

  • Page 38: Applying And Removing Treatment Heads

    Applying and Removing Treatment Heads Method of Disconnecting the Treatment Head: 1. Place your thumb and forefinger around the ribbed connector and exert moderate pressure of the digits against the CU. 2. At the same time, squeeze the connector. 3. Simultaneously, pull away from the CU to extract the cable. Figure 28 Disconnecting Treatment Array...

  • Page 39: Ls-Series

    LS-Series and SLD-Series The LS-Series Treatment Arrays may be secured directly to the body using the attached straps. When applying, place the Treatment Array over the area to be treated and wrap the straps around the body part. Place the Velcro from one strap over the Velcro portion of the other strap.

  • Page 40: Ld-Series

    Warnings for Using the Treatment Arrays: • Do not twist • Do not hyperextend • Do not drop • Do not tamper with diodes Note: The Treatment Arrays must be secured to allow air circulation around the top of the head. Do not cover the heads while running treatments, however you can use the Meditech approved weight set.
  • Page 41 Correct Application Incorrect Application Radiation ceases immediately when: • Contact with the skin ceases. • Pressing the “UP”, DOWN” or “SELECT” buttons. • Pressing “LASER STOP” button. The system is a stand-alone unit. NOTE: After selecting a treatment or continuing to the next phase, do NOT touch the tip of the Treatment Head until the indicators on the head turn green;...

  • Page 42: Operation

    Operation The following pages show screen shots and describe how to use the various functions of the BioFlex Therapist System: Main Screen Menu From the MAIN MENU you can select to run a treatment, customize a treatment, adjust the settings of the unit and also lock the unit from unauthorized use.
  • Page 43 UP/DOWN Use the buttons to scroll to the Pathology Pathology you want to treat and press C-Spine SELECT Scroll: UP/DOWN Select: SELECT Exit: EXIT UP/DOWN Use the buttons to scroll to Intensity the Intensity you want to use and press Stage One SELECT Scroll:...
  • Page 44 SELECT To start the treatment press LS Arrays View: UP/DOWN Start: SELECT Exit: EXIT During this time the Controller performs a LS Arrays treatment Head Check to test functionality of the System. The screen now asks you to place the LS Arrays treatment head on the area to be treated.
  • Page 45 This screen informs you of the current phase LS Arrays and time remaining for current phase of the LASER STOP button can be protocol. The pressed at any time during the treatment to immediately stop the emission of radiation and cease treatment. Pause: UP/DOWN Pause:...
  • Page 46 Customize a Treatment This section instructs you on how to customize a protocol using the Therapist CU. Pressing SELECT while the step number is Step 1 of 3 highlighted allows scrolling through the LS-R750 phases. Time 6 min WaveForm Squa...
  • Page 47 To set the specific parameter use the UP/ Step 1 of 3 DOWN buttons to scroll through the options. LS-R750 When you have found the option you want 6min Time to use, press SELECT to initiate change. WaveForm Squa Frequency 5000 DutyCycle Power...
  • Page 48 The screen now asks you to place the Custom ize Treatment Head on the area to be treated. Apply the Treatment Heads as described Step One in “Applying and Removing the Treatment Heads” section. Place the safety glasses provided with your system on and press SELECT to initiate treatment.
  • Page 49 The exit screen. Customize S tep O ne SELECT Exit: EXIT Stop: LASER STOP...
  • Page 50 Settings This section describes how to change the various settings. The settings will be discussed in more detail in the following illustrations. Settings Main Screen Settings Default Array To select an item from the menu, scroll through the options until the item is highlighted and press SELECT.
  • Page 51 Beep Control Beep Control Key Beep ON The Key Beep can be turned on or off. Key Beep is the audible beep heard when a button is pressed. This does not turn off the beeps heard during treatment. Use the UP/DOWN buttons to select either Key Beep ON or Key Beep OFF and press SELECT.
  • Page 52 Lock Password Settings This option is used to change the Lock Password. If you change the password write it down and place it in a safe and secure location. Lock Password Scroll: UP/DOWN Select: SELECT Exit: EXIT...
  • Page 53 System Lock The system lock is a software lock that password protects the system from unauthorized use. You should lock the system when it is not in use. The default lock password is 0000. If you change the password, write it down and keep it in a safe place. If you have lost your password contact Meditech or a Meditech authorized service center for further assistance.
  • Page 54 Other Screen Shots You will see the followings screens when the wrong Treatment Head is plugged into the Controller or if the Treatment Head becomes unplugged during a treatment. This screen is displayed when the correct Treatment Head in not plugged in. This screen is displayed when the treatment Run Treatment head is unplugged.

  • Page 55: Environmental Conditions

    Environmental Conditions The system is capable, while packed for transport or storage, of being exposed for a period of up to 15 weeks within the following ranges: • An ambient temperature range of -20˚C to +70˚C (-4˚F to +158˚F); • A relative humidity range of 10% to 100% (non-condensing); •...

  • Page 56: Calibration

    Calibration Calibration of the system and/or its components can only • be performed at Meditech or at an authorized service center. If any LD-Series Treatment Head indicates repeat • errors, it may need calibration. To maintain your arrays and to keep them working at •...

  • Page 57: Cleaning

    Cleaning The CU may be cleaned using a damped soft cloth • or a soft disinfectant cloth. The arrays may be cleaned with alcohol wipes, a soft • disinfectant cloth, a soft damp cloth and/or alcohol/ cotton swab combinations. A soft bristle brush can be used to remove particles •...

  • Page 58: If The System Becomes Damaged

    If the System Becomes Damaged If part or all of the system is dropped or damaged, check to determine if it still functions properly. To troubleshoot a system, perform the following steps: 1. Check all power connections. Make sure all cables are secure and properly connected.

  • Page 59: Guidelines For Proper Packaging

    Guidelines for Proper Packaging In order to ship the system, please follow the guidelines below for proper packaging: Use the original packaging that your system arrived in. • OR use a box with sufficient room for adequate • cushioning material for all sides of the container. Never exceed the maximum gross weight for the box (which is usually printed on the bottom lap).

  • Page 60: Error Messages

    Error Messages An error message will be displayed on the CU’s screen whenever Error Messages there is a problem with the system. All Treatment Heads are automatically tested prior to each use. An error message will be displayed on the CU’s screen whenever Should a fault occur within the Treatment Head, the user will be •...
  • Page 61 Trouble Shooting Guide MESSAGES VIA LCD POSSIBLE SOLUTION CAUSE NO POWER or Power supply Plug power supply into DISPLAY IS BLANK connected. hospital grade outlet. Power not turned on. Ensure cable is plugged into the Controller Unit. Press POWER button. LOCKED System is LOCKED to Each...
  • Page 62 MESSAGES VIA POSSIBLE CAUSE SOLUTION Head warning Treatment Head All Treatment Heads are be cold compared to tested prior to each use. Refer to warning code the room temperature You can still continue to L07 in manual or needs calibration or treat using the Treatment is malfunctioning.
  • Page 63 MESSAGES VIA POSSIBLE SOLUTION CAUSE Head error Treatment Head Stop treating with the Refer to error code may need calibration Treatment Head. ### in manual or is malfunctioning. Contact Meditech Error codes: L01, D01, D02, D03, L02, authorized service center L03, L04, L09 further assistance.

  • Page 64: Specifications

    Specifications Controller Unit Function Specifications Mode of Operation CW, Waveform Waveform Sine, Square and Triangle Duration 1-60 minutes (1 min resolution) 10-100Hz (10Hz resolution) Frequency Settings 250, 500, 1000, 2500, 5000 & 10000Hz Duty Cycle 10-90% (10% steps) Percent of Total Power 10-100% (10% steps) Table 1 Controller Unit (Customized Protocol) Function...

  • Page 65: Treatment Heads

    Treatment Heads PARAMETER UNITS LD-I 75 LD-I 200 LD-R100 LS-R750 LS-I 1500 Effective laser- LED class Total optical power 1500 Effective surface area 0.10 0.10 0.10 Power density mW/cm 1800 Number of devices Medium GaAlAs GaAlAs AlGaInP GaAlAs GaAlAs Type Coherence Wavelength Spectral Width...
  • Page 66 SLD- LS-B-2250 PARAMETER UNITS LS-R LS-I LS-B3000 SLD- 1000 Effective laser- LED class Total optical 1000(red) 1000 750(red) power 2000(infrared) 1500 (infrared) Effective surface area Power density mW/cm 10(red) 13.0 10(red) 20 (infrared) 20 (infrared) Number of devices Medium GaAlAs GaAlAs AlGaInP (red) GaAl...

  • Page 67: Glossary

    Glossary Light Emitting Diode Super Luminous Diode Liquid Crystal Display Laser Diode Controller Unit Electromagnetic Compatibility Maximum Permissible Exposure NOHD Nominal Ocular Hazard Distance...

  • Page 68: System Parts List

    DUO (LS-B 2250) Array 500mW Red Super Luminous Diode Array SLD-R 500 1000mW Infrared Super Luminous Diode Array SLD-I 1000 BioFlex Single Laser LD-I 200 LD-I 200 BioFlex Single Laser LD-I 75 LD-I 75 BioFlex Single Laser LD-R 100 LD-R 100...
  • Page 71 415 Horner Ave. Toronto Ontario, M8W 4W3 Phone:(416)251-1055 Fax:(416)251-2446 Toll Free:(888)557-4004 www.biofl exlaser.com info@biofl exlaser.com copyright©2014 Meditech International Incorporated. ALL RIGHTS RESERVED MT-ENG-MN-100652...

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