Richmar TheraTouch LX2 Operation Manual
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Richmar TheraTouch LX2 Operation Manual

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TheraTouch® LX2
OPERATION MANUAL

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Summary of Contents for Richmar TheraTouch LX2

  • Page 1 TheraTouch® LX2 OPERATION MANUAL...
  • Page 2 PRECAUTIONARY INSTRUCTIONS Declaration of Conformity: Richmar declares that the The precautionary instructions found TheraTouch® LX2 complies with in this section and throughout this following normative documents: manual are indicated by specific symbols. Understanding these symbols IEC60601-1, IEC60601-2-22, IEC60825-1 and their definitions before operating this equipment.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS WARRANTY ......................1 FOREWORD ......................2 PRODUCT DESCRIPTION ................2 PRECAUTIONARY INSTRUCTIONS ............3 INTENDED USE .....................4 PACKAGE CONTENTS..................5 INSTALLATION ......................6 APPLICATION INFORMATION...............6 TREATMENT TIPS ....................7 OPERATING INSTRUCTIONS .................7 DEVICE USER INTERFACE................9 MAINTENANCE ....................17 SPECIFICATIONS ....................19 PROTOCOL PARAMETERS ................21 APPENDIX ......................24 GLOSSARY OF SYMBOLS ................

  • Page 4: Warranty

    RA number will be transport to the service center. returned to the sender. Richmar will not be Accessories which are subject to responsible for damage due to improper normal wear and tear (Accessories packaging or shipment.

  • Page 5: Foreword

    WARNING by Richmar under a separate support TheraTouch LX2 is Rx ONLY and should agreement (if any), with the exception only be used under the supervision or by of death or personal injury caused by...

  • Page 6: Precautionary Instructions

    PRECAUTIONARY INSTRUCTIONS • In this section general Warnings and Use of controls or adjustments or Cautions are listed, that you should be performance of procedures other than aware of when using the LX2. Also, see those specified herein may result in warnings and cautions that are hazardous exposure to laser energy.

  • Page 7: Intended Use

    • Pregnancy: LLLT should not be administered over the low back, Expect the following effects on tissues abdomen or pelvic area during treated with TheraTouch LX2 laser therapy: pregnancy, • Increased local blood circulation • Neoplasms: you must not use laser •...

  • Page 8: Package Contents

    INTENDED USE • Frequency – Determines the number of Photosensitive patients, or those taking photosensitizing medications laser pulses delivered per second during a pulsed treatment and is measured in • Recent surgery or cryotherapy areas Hz. Depending on the frequency selected, and inflammation.

  • Page 9: Installation

    • label on the bottom of your device. At the end of the self test the device enters Do not connect the TheraTouch LX2 to the password interface and is ready for use. a power supply rated differently than DISCONNECTION FROM MAINS SUPPLY described above.

  • Page 10: Treatment Tips

    TREATMENT TIPS CONTACT PRE & POST TREATMENT For most effective results, the applicator Cold: If treating with cold therapy as part of should be in contact with the patient's skin the treatment regimen, apply cold therapy and may require multiple applications around prior to laser treatment as it reduces the the treatment area.
  • Page 11 OPERATING INSTRUCTIONS SHORTCUT BUTTONS ICON NAME DETAILS Stop Press this button to stop treatment immediately. Clinical Protocols Press this button to go directly to the clinical protocols when device is in standby. Favorites Press this button to enter stored favorites when device is in standby.

  • Page 12: Device User Interface

    DEVICE USER INTERFACE SOFTWARE SYMBOLS (CONTINUED) ICON NAME DETAILS B Indicator Detects applicator plugged into B port Wavelength/ Active Laser Applicator State Indication Power Frequency Frequency Indication (only in pulsed mode) Setting Start Button Press to activate applicator for treatment (does not start treatment) Treatment Time Treatment Time Indication...
  • Page 13 DEVICE USER INTERFACE CLINICAL PROTOCOLS HOME SCREEN The Home Screen includes the following functions: • Clinical Protocols • Favorites • Manual Operation • System Settings Press Clinical Protocols CLINICAL PROTOCOLS SCREEN For Treatment Information, such as specific parameters for each clinical indication, press the left side of the desired protocol.
  • Page 14 DEVICE USER INTERFACE CLINICAL PROTOCOLS CONTINUED Applicator Selection • Press and rotate the central controller dial to change from either a Single or Cluster applicator.* • If using an LX2 with both applicators, the device will recognize which applicator is plugged into each Connection Port.
  • Page 15 DEVICE USER INTERFACE SAVING FAVORITES You may only save Favorites prior to beginning a treatment, or after a treatment has ended TREATMENT SCREEN • To begin saving a Favorite from the Treatment Screen, press SAVE FAVORITE SCREEN • Enter the name of your Favorite, using the keyboard. Note: Per HIPPA Guidelines, you should not store favorites under a patient's name.
  • Page 16 DEVICE USER INTERFACE MANUAL OPERATION Manual Operation allows the user to select customizable parameters specific to the patient. HOME SCREEN • Press Manual Operation to navigate directly to the Treatment Screen. TREATMENT SCREEN To change a specific parameter, press the button on the screen and use the central controller dial to adjust to desired setting.
  • Page 17 DEVICE USER INTERFACE MANUAL OPERATION CONTINUED Dosage Selection • Touch the energy density area to highlight it orange. Then adjust the density by rotating the Central Controller Dial. • The energy density selected, will change the treatment time automatically. You cannot increase the treatment time without the device also changing the energy density level.
  • Page 18 DEVICE USER INTERFACE SYSTEM SETTINGS System Settings In this screen you can personalize some features on the device such as: • Language • LCD Brightness • Speaker Volume • End of Treatment Sound CHANGING THE PASSWORD System Settings • From the System Settings Menu, select Maintenance.
  • Page 19 DEVICE USER INTERFACE CHANGING THE PASSWORD CONTINUED • If the passwords match, the system will display it was successful. • If they do not match, an error code 708 will show that the passwords were inconsistent and you will have to reenter again. EMERGENCY SHUTOFF FOR FACTORY RESET •...

  • Page 20: Maintenance

    MAINTENANCE CLEANING & DISINFECTING • The device and associated accessories may not be sterilized using steam or When cleaning the device, keep in mind gas. the following: • Never clean the device with abrasives, • Press the Power On/Off button so that disinfectants, or solvents that could the device is off.
  • Page 21 All other technical maintenance is CALIBRATION restricted to authorized Richmar It is recommended to calibrate the laser maintenance personnel. source every 1 year. The device END OF LIFE...

  • Page 22: Specifications

    SPECIFICATIONS THERATOUCH LX2 Power Supply 100-240V AC 50/60Hz Maximum absorbed power Programmable treatment time Up to 4 minutes Mode of operation Continuous or pulsed Emission frequency 1Hz-10000Hz Pulsed mode Output channels LCD back-lit display Graphic 480 X 800 pixels TOUCH SCREEN...
  • Page 23 LASER APPLICATOR SPECIFICATIONS Below is an example parameter description when calculating the dosage for both the single and cluster applicators available for the TheraTouch LX2 Low Level Laser Therapy (LLLT) device. For both applicators, the standard deviation in measured quantities at the time of manufacturing is +/-20%.

  • Page 24: Protocol Parameters

    PROTOCOL PARAMETERS TREATMENT RECOMMENDATIONS 1. Before starting therapy, ensure patient and clinician put on protective eyewear. 2. Treatment area should be cleaned with alcohol. DO NOT using coupling agents on laser applicator. 3. Place the applicator directly on the skin with firm comfortable pressure and no tilting of the applicator head, for maximal energy.
  • Page 25 PROTOCOL PARAMETERS TREATMENT RECOMMENDATIONS 1. Before starting therapy, ensure patient and clinician put on protective eyewear. 2. Treatment area should be cleaned with alcohol. DO NOT using coupling agents on laser applicator. 3. Place the applicator directly on the skin with firm comfortable pressure and no tilting of the applicator head, for maximal energy.
  • Page 26 SPECIFICATIONS SAFETY AND PERFORMANCE • The medical devices should not be STANDARDS used adjacent to or stacked with other equipment. In case adjacent or stacked IEC 60601-1 : General requirements for use is necessary, the medical device the safety of electrical medical systems, should be observed to verify normal including Annex 1, national differences for operation in the configuration in which it...

  • Page 27: Appendix

    APPENDIX A - EMC TABLES TABLE 1: GUIDELINES AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC INTERFERENCE TheraTouch LX2 is intended for operation in an electromagnetic environment as indicated below. The customer or user of the LX2 device should ensure that it is operated in such an environment.
  • Page 28 APPENDIX A - EMC TABLES TABLE 2: GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY Guidance and manufacturer’s declaration — electromagnetic immunity The LX2 device is intended for use in the electromagnetic environment specified below. The customer or the user of the LX2 device should assure that it is used in such an environment.
  • Page 29 APPENDIX A - EMC TABLES TABLE 3: GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY Guidance and- manufacturer’s declaration. Electromagnetic immunity The LX2 device is intended for use in. the electromagneticenvironment specified below. The customer or the user of the LX2 should assure that it is used in such an environment. Immunity test IEC 60601 Compliance...
  • Page 30 APPENDIX A - EMC TABLES TABLE 4: RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND LX2 Recommended separation distances between portable and mobile RF communications equipment and the LX2 device The LX2 device device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 31: Glossary Of Symbols

    GLOSSARY OF SYMBOLS GLOSSARY OF GENERAL SYMBOLS 11.1 Glossary of General symbols 11.1 Glossary of General symbols 11.1 Glossary of General symbols 11.1 Glossary of General symbols ICON DETAILS Electrical devices are recyclable material and should not Electrical devices are recyclable material and should not Electrical devices are recyclable material and should not be disposed of with Electrical devices are recyclable material and should not be disposed of with household waste after their useful life!
  • Page 32 Manufactured for: Compass Health Brands Corp. Toll Free 1.888.549.4945 6753 Engle Road Middleburg Heights, OH 44130 richmarweb.com 3158.18.10.B ©2019 Compass Health Brands Corp.

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