BIOFLEX Home Unit Operation Manual Download Page 11

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Safety Kit

The BioFlex Safety Kit consists of the following:

• Laser Safety Guide

• Laser Danger Sign

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

for the patient)

Please read the Laser Safety Guide. Post the danger sign outside

the entrance to the room where the system is located. If there is

more than one entrance into the room where the system is

located, please contact Meditech to obtain additional signs to

post in these areas.

Summary of Contents for Home Unit

Page 1: ...01 Operation Manual Therapist Therapist Pro Home Unit...

Page 2: ...THERAPIST Therapist Operation Manual Safety Installation and Operation Instructions Meditech International Inc...

Page 3: ...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...

Page 4: ...nditions in the musculo skeletal field These include sports injuries repetitive motion syndrome and the arthritides To date we have surpassed our initial goals and expectations but each day advances o...

Page 5: ...t and the Far East using the MPU30A 1 1 AC adapter AC adapters are available by contacting Meditech or your local distributor To help prevent electric shock plug the Controller Unit CU into properly g...

Page 6: ...enu screen To reduce the risk of electric shock do not remove covers from any part of the system There are no serviceable parts inside Refer servicing to Meditech s qualified service personnel Wear sa...

Page 7: ...system should be installed and operated according to CAN CSA Z386 2001 Laser Safety in Health Care Facilities Equipment should not be used adjacent to or stacked with other equipment and that if adjac...

Page 8: ...Reflections from the beam can be nearly as intense as the beam itself The entrances to the area should be posted with the provided laser danger sign Never look directly into the laser beam or stare at...

Page 9: ...ly harmful laser light to irradiate surrounding areas Correct Application Incorrect Application Figure 1 LD Series Treatment Head Application Safety Glasses Use FAILURE TO FOLLOW THESE INSTRUCTION MAY...

Page 10: ...your eyewear and replace your eyewear immediately Always keep your safety glasses in the Therapist carrying case when not in use Never use the safety glasses for any purpose other than for eye protect...

Page 11: ...ses one for the practitioner and one for the patient Please read the Laser Safety Guide Post the danger sign outside the entrance to the room where the system is located If there is more than one entr...

Page 12: ...ity EMC Explanation of Warning Symbols and Labels Controller Unit CU Classification Marks LD Series Treatment Head Labels LS Series Treatment Head Labels SLD Series Treatment Head Labels DUO Treatment...

Page 13: ...emoving Treatment Heads LS Series LD Series Operation Environmental Conditions Calibration Cleaning If the System Becomes Damaged Guidelines for Proper Packaging Error Messages Specifications Controll...

Page 14: ...1 2005 CLASS I EQUIPMENT according to the type of protection against electric shock TYPE B APPLIED PART according to the degree of protection against electric shock NOT CLASSIFIED according to the deg...

Page 15: ...erformance 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 e...

Page 16: ...nformation provided in this manual The use of accessories and cables other than those specified and sold by the manufacturer may result in increased emissions or decreased immunity of the equipment an...

Page 17: ...y 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 ele...

Page 18: ...17 LD Series Treatment Head Labels Figure 2 LD I 75 Treatment Head Explanatory Label Figure 3 LD I 200 Treatment Head Explanatory Label 17...

Page 19: ...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 AVO...

Page 20: ...ase see Description of the Beam Delivery System Figure 6 LD Series Treatment Head Hazard Symbol YELLOW TRIANGLE This is a hazard label warning that the system emits hazardous light See CLASS 3B LASER...

Page 21: ...re 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 be...

Page 22: ...21 LS Series Treatment Head Labels Figure 9 LS R 250 Treatment Head top label Figure 10 LS R 250 Treatment Head bottom label 21...

Page 23: ...22 22 Figure 11 LS I 500 Treatment Head top label Figure 12 LS I 500 Treatment Head bottom label...

Page 24: ...23 Figure 13 LS R 750 Treatment Head top label Figure 14 LS R 750 Treatment Head bottom label 23...

Page 25: ...24 24 Figure 15 LS I 1500 Treatment Head top label Figure 16 LS I 1500 Treatment Head bottom label...

Page 26: ...igure 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 L...

Page 27: ...nts 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 conti...

Page 28: ...ironment 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 sh...

Page 29: ...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 figu...

Page 30: ...29 System Features Indicators and Controls Controller Unit THERAPIST EXIT Figure 21 Front of CU 29 SELECT...

Page 31: ...nt of the CU Press once to turn on the system Press POWER LASER STOP for approximately 1 second to shut off the system Pressing POWER LASER STOP during treatment will immediately stop the treatment an...

Page 32: ...31 Figure 22 Back of the CU Date of Manufacture Refer to the CU s serial number label for the date of manufacture The format of the serial number is shown below 31...

Page 33: ...mat 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 Fi...

Page 34: ...ore they can lock Align the mark on the plug with the mark on the socket Power Input Input for the power adapter Do not use any other adapter except the one provided by Meditech or your local distribu...

Page 35: ...34 LS Series SLD Series Treatment Arrays Figure 25 LS Series Figure 26 DUO Series Figure 27 SLD Series 34...

Page 36: ...table and that they should notify the administering practitioner if they do To prevent the treatment arrays from becoming too warm or uncomfortable to the patient it is recommended that the operator s...

Page 37: ...ocations 36 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 d...

Page 38: ...tment 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 fr...

Page 39: ...e 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 stra...

Page 40: ...xt phase wait until the indicators on the Treatment Head turn green before applying the Head Once the indicators are green apply the Treatment Head tip to the treatment area and the treatment will beg...

Page 41: ...ng a treatment or continuing to the next phase do NOT touch the tip of the Treatment Head until the indicators on the head turn green otherwise the Treatment Head will not work If you do touch the tip...

Page 42: ...reen Menu From the MAIN MENU you can select to run a treatment customize a treatment adjust the settings of the unit and also lock the unit from unauthorized use This is the main menu when the system...

Page 43: ...T Use the UP DOWN buttons to scroll to the Pathology you want to treat and press SELECT Use the UP DOWN buttons to scroll to the Intensity you want to use and press SELECT Press the UP DOWN buttons to...

Page 44: ...eatment Head Check to test functionality of the System The screen now asks you to place the treatment head on the area to be treated Apply the Treatment Heads as described in Applying and Removing the...

Page 45: ...ASER STOP button can be pressed at any time during the treatment to immediately stop the emission of radiation and cease treatment Pressing either of the UP DOWN EXIT or SELECT buttons will pause the...

Page 46: ...is highlighted allows scrolling through the phases To set the Treatment Head TH Time Waveform Frequency Duty Cycle and Power highlight the parameter and press SELECT The highlighted area will change s...

Page 47: ...through the options When you have found the option you want to use press SELECT to initiate change To Run the protocol just created plug in the appropriate head scroll to Run Treatment from any phase...

Page 48: ...press SELECT to initiate treatment This screen informs you of the current phase and time remaining for current phase of the protocol The LASER STOP button can be pressed at any time during the treatm...

Page 49: ...48 48 Customize Step One SELECT EXIT LASERSTOP The exit screen No Exit Stop...

Page 50: ...Scroll Select Exit System Info This screen provides the Treatment Head serial number firmware version and the Controller serial number and firmware version Press EXIT to go back to the Settings menu E...

Page 51: ...eatment Use the UP DOWN buttons to select either Key Beep ON or Key Beep OFF and press SELECT LCD Contrast To adjust the contrast of the screen use the UP DOWN buttons to adjust the levels of contrast...

Page 52: ...ll Select Exit UP DOWN SELECT EXIT Lock Password This option is used to change the Lock Password If you change the password write it down and place it in a safe and secure location 51 Settings Lock Pa...

Page 53: ...ress SELECT The cursor will move to the next digit Repeat until you have entered the password and Press SELECT The system lock is a software lock that password protects the system from unauthorized us...

Page 54: ...nto the Controller or if the Treatment Head becomes unplugged during a treatment This screen is displayed when the correct Treatment Head in not plugged in Run Treatment 53 This screen is displayed wh...

Page 55: ...C 4 F to 158 F A relative humidity range of 10 to 100 non condensing An atmospheric pressure range of 500hPa to 1 060hPa When the system is operated in accordance with the instructions for use the fol...

Page 56: ...ibrated periodically depending on use The Controller Unit CU does not require calibration Note Only Meditech authorized service personnel are able to calibrate the system properly Unauthorized changes...

Page 57: ...atment heads may be cleaned with alcohol wipes a soft disinfectant cloth a soft damp cloth and or alcohol cotton swab combinations It is recommended that the treatment surface of the Treatment Arrays...

Page 58: ...sure all cables are secure and properly connected 2 Turn on the CU If the CU does not work contact a Meditech authorized service center for technical assistance Liquids from spills or excessive humid...

Page 59: ...rapping each item separately To prevent damage to the contents ensure that they are separated from the corners and sides of the box Various materials can be used for cushioning and protection i e air...

Page 60: ...d with discretion If your system requires service please contact a Meditech authorized service center Error Messages An error message will be displayed on the CU s screen whenever there is a problem w...

Page 61: ...into hospital grade outlet Ensure cable is plugged into the Controller Unit Press POWER button LOCKED Press any key to enter password to unlock System is LOCKED to avoid unauthorized use Each stage o...

Page 62: ...tment Head and send in for service Head warning Refer to warning code L06 LD8 in manual Treatment Head may be hot or needs calibration or is malfunctioning All treatment heads are tested prior to each...

Page 63: ...Treatment Head If the problem persists contact a Meditech authorized service center for further assistance Provide warning code to the service center System failure Refer to error code in manual Cont...

Page 64: ...ion 10 100Hz 10Hz resolution 250 500 1000 2500 5000 10000Hz 10 90 10 steps 10 100 10 steps Function Specifications Mode of Operation Waveform Duration Frequency Settings Duty Cycle Percent of Total Po...

Page 65: ...10 20 Number of devices 1 1 1 179 179 Medium GaAlAs GaAlAs AlGaInP GaAlAs GaAlAs Type LD LD LD SLD SLD Coherence mm 1 1 N A 0 0 Wavelength nm 830 830 660 660 840 Spectral Width nm 3 0 3 0 N A 25 0 50...

Page 66: ...of devices 59 59 240 120 120 180 Medium GaAlAs GaAlAs AlGaInP red AlGaInP infrared GaAl As GaAlAs AlGaInP red AlGaInP infrared Type SLD SLD SLD SLD SLD SLD Coherence mm 0 0 0 0 0 0 Wavelength nm 660...

Page 67: ...D Light Emitting Diode SLD Super Luminous Diode LCD Liquid Crystal Display LD Laser Diode CU Controller Unit EMC Electromagnetic Compatibility MPE Maximum Permissible Exposure NOHD Nominal Ocular Haza...

Page 68: ...uper 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...

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Page 71: ...e Toronto Ontario M8W 4W3 Phone 416 251 1055 Fax 416 251 2446 Toll Free 888 557 4004 www bioflexlaser com info bioflexlaser com copyright 2014 Meditech International Incorporated ALL RIGHTS RESERVED M...

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