Erchonia FX 635 Operation & Maintenance Manual
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Erchonia FX 635 Operation & Maintenance Manual

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Operation &
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Read this entire booklet before using your FX 635 Laser

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Summary of Contents for Erchonia FX 635

  • Page 1 Operation & Maintenance Manual Read this entire booklet before using your FX 635 Laser...
  • Page 2 READ THIS FIRST To ensure proper use, and to achieve your best results, it is important that you read and understand the instructions, warnings, precautions and safety information in this booklet before using your FX 635 laser for the first time.

  • Page 3: Table Of Contents

    PACKAGE CONTENTS ............................ 1 SYMBOLS USED ON THE EQUIPMENT....................... 2 SAFETY INFORMATION ..........................3 NOTIFICATION OF ADVERSE EVENTS ...................... 6 ERCHONIA LASER INDICATIONS FOR USE ....................6 TECHNICAL INFORMATION ......................... 6 SERVICE AND REPAIR ........................... 6 SECTION 2 PRODUCT OVERVIEW ........................7 NOMENCLATURE ............................
  • Page 4 MAINTENANCE AND CLEANING ......................41 FUSE REPLACEMENT ........................... 41 WARRANTY ..............................42 CONTACT US..............................43 LASER HEAD ASSEMBLY REMOVAL & INSTALLATION FOR SERVICE .......... 44 GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSIONS & IMMUNITY ..............................46 TECHNICAL SPECIFICATIONS ........................49...

  • Page 5: Section 1 General Information

    SECTION 1 GENERAL INFORMATION This Erchonia ® FX 635, model: HPS Operator’s Guide is designed to take you through set-up and proper use of your device. It will cover the Device Overview, Operation, Cautions, Warnings, Professional Use Instructions and Maintenance and Warranty Information.

  • Page 6: Symbols Used On The Equipment

    SYMBOLS USED ON THE EQUIPMENT Any or all of the following symbols may be used in this manual or on this equipment: SYMBOL DESCRIPTION Temperature Limitation Type B patient connection - applied parts that are generally not conductive and can be immediately released from the patient.

  • Page 7: Safety Information

     Cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord WARNINGS You must follow these Instructions for Use when using the FX 635 laser. Not following these instructions may result in serious injury.
  • Page 8 WARNINGS (Continued) Dispose of device in accordance with local and national regulations and codes. When spent and beyond repair or functional use, the device can be sent back to the manufacture for disposal. This ensures the proper separation and handling of all the internal parts and reduces any risk to the end user and the environment. Risk of explosion if used in the presence of flammable anesthetics.
  • Page 9 There are no user-serviceable parts inside the device except the fuses. If a malfunction occurs, discontinue use immediately and contact Erchonia® Corporation for repair service. Inspect electrical cord and associated connectors before each use. ONLY use the power cord supplied with the device.

  • Page 10: Notification Of Adverse Events

    Name of the person to contact RETURNING A DEVICE FOR SERVICE • Before sending a device to the Erchonia Service and Repair Department for repair, obtain a service order (SO) number from the service representative. • Pack the device and charger in the original containers (if available) or equivalent packaging. Be sure the assigned service order number appears on the package.

  • Page 11: Section 2 Product Overview

    SECTION 2 PRODUCT OVERVIEW NOMENCLATURE The Erchonia® FX 635 emits a 640 nanometer wavelength with a tolerance of ±10 nanometer, from each of the three specially created and patented electronic diodes. ® The Erchonia FX 635 laser is manufactured in accordance to the Good Manufacturing Procedures consistent with national regulatory agencies;...
  • Page 12 The device contains a hospital grade flexible detachable power cord. Plug the power cord into the Power Inlet Module [2] prior to plugging the other end into a wall socket. The power cord does not contain any operator-serviceable components. If the power cord needs replacement, contact an Erchonia Corporation representative. Fig. 3...
  • Page 13 The system uses two 2-amp fuses, which will only require replacement if there is an issue. NOTE: Two keys are included with the Erchonia® FX-635. (Brass with nickel plating). The device requires one (1) key to operate;...
  • Page 14 DEVICE HANDLE [5] The Device Handle gives the user the ability to move the device for proper positioning to patient for accurate treatment location as well as move the device for storage or relocate to a different room. When the device is moved you must unlock the Wheel Locks [6].
  • Page 15 It is designed to adjust by intentional force from the end user; allowing the user to change the angle for proper positioning to patient for accurate treatment distance. PROTECTIVE EYEWEAR [16] The Erchonia ® FX635 is classified by the FDA/IEC as a Class 2 laser device. This designation represents a current standard for use in order to ensure the safety of the patient.
  • Page 16 HEIGHT EXTENSION BLOCK W/ LOCKING KNOB [17] The Height Extension Block w/ Locking Knob is an accessory that allows the device to treat at a higher height. To install the Height Extension Block w/ Locking Knob onto the device, first unscrew and remove the locking knob from the extension block.

  • Page 17: Section 3 Setup & Operation

    SECTION 3 SETUP & OPERATION Now that you understand the basic features of the Erchonia® FX-635, it is important to understand how to use them when administering treatments. Below are the steps for setting the patient up for treatment. WHEEL LOCKS The device includes four antistatic wheels that enable ease for maneuverability.
  • Page 18 CAUTION: PINCH HAZARD Keep hands and fingers clear from areas indicated. 1) Adjust the Laser Head Assembly height for proper positioning to patient for accurate treatment Place patient in treatment position under the Laser Head Assembly. Grab the Laser Head Assembly Handle and raise or lower the Main Arm to the optimal height for treating patient.
  • Page 19 CAUTION - When adjusting the Laser Head Assembly angle follow instructions below, keeping your hands and fingers clear of pinch points. 2) Adjust the Laser Head Assembly angle for proper positioning to patient for accurate treatment. First, grasp the Laser Head Assembly Handle and pull up while pushing the Head Assembly Lever Lock back; continue to hold Head Assembly Lever Lock in the back position and hold the Laser Head Assembly Handle.
  • Page 20 3) Adjust the Laser Head Assembly arms and laser heads for proper positioning to patient for accurate treatment. Grab the Laser Head Assembly Handle and rotate the Laser Head Assembly left or right. Grab the Upper Laser Arms and move up or down, left or right. Grab the Lower Arms and rotate left or right, or move up or down. Grab the Left & Right Laser Heads and move up or down.

  • Page 21: Powering Up The Device

    To access the Quick Program and the Preset Protocols, touch the “Quick & Preset Protocols” icon. b. To access the User Protocols, touch the “User Protocols” icon. c. To access the Credit & Device Information Screen, touch the “Erchonia” icon.

  • Page 22: Preset Protocols

    PRESET PROTOCOLS There are 7 preset protocols implemented into the device software, preset for particular pain indications: Head and Cerebellum • Home Screen Neck • • Shoulder Elbow • Wrist/Hand • • Low Back Knee • Ankle/Foot • • Heel Post-Op •...
  • Page 23 4. To pause, touch the “PAUSE” icon. When the procedure is paused, you will observe the following: three red laser diodes and rotation turn off; • (Example) Low Back Screen the time remaining counter pauses; • the “PAUSE” icon will flash, displaying “RESUME”; •...

  • Page 24: User Protocols For Other Pain Indications

    USER PROTOCOLS FOR OTHER PAIN INDICATIONS Home Screen User Protocols allows the user to program up to 40 additional pain indications. Protocol programming consists of: the protocol name, the protocol laser frequency/Hz & the protocol treatment time. 1. To access the user protocols, touch the “User Protocols” icon located on the Home Screen.
  • Page 25 User Protocol Settings Screen 4. To program a protocol name, touch the “Protocol Name Entry” icon. The screen will change to the Protocol Name Entry Screen. 5. Enter the protocol name (up to 20 characters) and touch the “ENTER” icon. The screen will change back to the User Protocol Settings Screen. Protocol Name Entry Screen 6.
  • Page 26 13. To pause, touch the “PAUSE” icon. When the procedure is paused, you will observe the following: User Protocol Screen three red laser diodes and rotation turn off; • the time remaining counter pauses; • the “PAUSE” icon will flash, displaying “RESUME”; •...

  • Page 27: Quick Program For Other Pain Indications

    QUICK PROGRAM FOR OTHER PAIN INDICATIONS Home Screen Quick Program allows the user to program an additional pain indication. Protocol programming consist of: the protocol laser frequency/Hz & the protocol treatment time. 1. To access the quick program, touch the “Quick & Preset Protocols” icon located on the Home Screen.
  • Page 28 Quick Program Settings Screen 4. To program a frequency/Hz, touch one of the “Hz ENTRY” icons. The screen will change to the Numeric Keypad Screen. Protocol Name Entry Screen 5. Enter the Hz (1 – 100,000) for Hz1 and touch the “ENTER” icon. Note: The screen will not change as Hz2 still needs to be entered.
  • Page 29 Quick Program Screen 10. Touch “START” icon to begin the non-invasive procedure. Once you start the procedure you will observe the following: three visible red laser diodes turn on rotating clockwise; • • the time remaining window starts counting down; the “START”...

  • Page 30: Credit & Device Information Screen

    Information Screen allow you to view the amount of remaining credits on the device at any time. To ensure that your device is operational at all times, contact Erchonia’s Sales Support before the credits remaining reaches 0. Once the credits remaining reaches 0, the device will no longer operate.

  • Page 31: To Add Credits

    4. Touch the “Unlock Code” icon. The screen will change to the Numeric Keypad Screen. (Example) Proper Code Entered 5. Enter the 8 digit unlock code given to you by the Erchonia representative then touch the “ENTER” icon. The screen will change back to the Credit & Device Information Screen.

  • Page 32: Labels

    LABELS The device is manufactured in accordance to the Good Manufacturing Procedures set forth by the FDA, ISO Standards (International) and CE (Certified European) standards and testing results per Article 9, the device is a Class I Shock Protection and a Class II Medical device. Each of these governing agencies requires specific labeling. All required labels affixed according to the relevant codes.
  • Page 33 The following diagram shows the location of the pinch point labels. On the opposite side of arm there are pinch point labels in the same location. When transporting the device (example: from one room to another) ensure that the main arm is collapsed into the device and take caution to ensure the device does not tip.
  • Page 34 The following diagram shows each of the laser diodes (3) have a label affixed that show the direction of the laser beam output and the additional locations of the pinch point labels. Note: Reference “Main Arm” in “Product Overview” section for further detail of pinch points and un-collapsing the main arm.

  • Page 35: Section 4 Professional Use Instructions

    This section defines instructions for the application of the laser energy and established protocols. The Erchonia Laser device is intended for use by health care professionals as an adjunct use for the temporary relief of pain. The treatment protocols that are hardcoded into the device has been developed in conjunction with Medical Doctors, Erchonia Corporation Researchers and IRB advisors.

  • Page 36: Low Back Protocol

    3. The Erchonia Laser is activated. 4. The laser diodes laze each of these 3 areas for 20 minutes simultaneously. 5. The patient rises and leaves the procedure administration room.

  • Page 37: Neck Protocol

    3. The Erchonia Laser is activated. 4. The laser diodes laze each of these 3 areas for 10 minutes simultaneously. 5. The patient rises and leaves the procedure administration room.

  • Page 38: Elbow Protocol

    (anconeus) c. the right laser on the lateral epicondyle 3. The Erchonia Laser is activated. 4. The laser diodes laze each of these 3 areas for 10 minutes simultaneously. 5. The patient rises and leaves the procedure administration room.

  • Page 39: Ankle/Foot Protocol

    (dorsal aspect); c. the right laser on the lateral ankle 3. The Erchonia Laser is activated. 4. The laser diodes laze each of these 3 areas for 10 minutes simultaneously.

  • Page 40: User Protocols

    3. The administrator positions one, two or all three of the laser lights between 3 and 4 inches away from, but directed toward, area of pain. 4. The Erchonia Laser is activated. 5. The laser diodes laze each of these 3 areas for 1-20 minutes simultaneously.

  • Page 41: Clinical Trial Summaries

    CLINICAL TRIAL SUMMARIES NECK AND SHOULDER PAIN This pivotal study was a prospective, multi-center (3 U.S. sites), randomized, double-blinded, placebo-controlled multi- arm study of 100 subjects, of which 50 were randomized to the active treatment group and 50 were randomized to the control (placebo) group.
  • Page 42 POST-OPERATIVE PAIN FOLLOWING LIPOSUCTION This pivotal study was a prospective, multi-center (3 U.S. sites), randomized, double-blinded, placebo-controlled multi- arm study of 70 subjects, of which 36 were randomized to the active treatment group and 34 were randomized to the control (placebo) group. The device was administered to each treatment area pre-surgery, separately, for 12 minutes per area.
  • Page 43 HEEL PAIN FROM PLANTAR FASCIITIS This pivotal study was a prospective, multi-center (2 U.S. sites), randomized, double-blinded, placebo-controlled multi- arm study of 69 subjects, of which 37 were randomized to the active treatment group and 32 were randomized to the control (placebo) group.
  • Page 44 LOW BACK PAIN This pivotal study was a prospective, multi-center (3 U.S. sites), randomized, double-blinded, placebo-controlled multi- arm study of 58 subjects, of which all 29 were randomized to the active treatment group and 29 were randomized to the control (placebo) group. The device was administered across the lower back region for twenty minutes per treatment: two treatments per week, each three of four days apart, across a consecutive four-week period, for a total of eight treatments.

  • Page 45: Section 5 Maintenance & Warranty Information

    MAINTENANCE AND CLEANING DEVICE MAINTENANCE ® The Erchonia Laser, if used according to the instructions contained within this manual, will operate efficiently for years. To ensure proper care, it is advisable for the end user to perform: 1. Regular visual inspections to ensure there is no external damage other than normal wear and tear. Inspect all cords for signs of excessive wear (cuts in insulation or fraying).

  • Page 46: Warranty

    Exposure to the elements o Ingress of liquid o Exposure to excessive electromagnetic frequency PRODUCT CHANGES Erchonia Corporation reserves the right to make changes and improvements to its products without incurring any obligation to incorporate such improvements in products previously sold.

  • Page 47: Contact Us

    CONTACT US Questions? If for any reason you are dissatisfied with this product, warranty concerns or questions regarding proper operation, please contact our Erchonia® Customer Care representative for assistance. Contact us at: Erchonia Customer Care Phone: 1-321-473-1251 Email: info@erchonia.com Or visit erchonia.com Copyright ©...

  • Page 48: Laser Head Assembly Removal & Installation For Service

    DO NOT remove the Laser Head Assembly unless authorized by the Erchonia Service Department. The Laser Head Assembly can be removed from the device for service with authorization from the Erchonia Service Department. Follow the steps below in order to remove the laser head assembly from the device.
  • Page 49 DO NOT install the Laser Head Assembly unless authorized by the Erchonia Service Department. The Laser Head Assembly can be installed onto the device for service with authorization from the Erchonia Service Department. Follow the steps below in order to install the laser head assembly onto the device.

  • Page 50: Guidance And Manufacturer's Declaration-Electromagnetic Emissions & Immunity

    EMC information provided in this document. Portable and mobile RF communications equipment can affect the medical electrical equipment. ® This declaration currently applies to the Erchonia [HPS] device. GUIDANCE AND MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSIONS The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
  • Page 51 GUIDANCE AND MANUFACTURER’S DECLARATION-ELETROMAGNETIC IMMUNITY The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment. Immunity test IEC60601-1-2 test level Compliance level Electromagnetic environment-guidance Electrostatic...
  • Page 52 assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the [HPS] is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.

  • Page 53: Technical Specifications

    EMC 2014/30/EU LVD 2014/35/EU IEC 60601-1-2 EMC IEC 60601-1 Safety IEC 60825-1 – Laser Safety CB Certified Specifications Trade Name: Erchonia FX 635 ® Device Model Number: HPS Weight: 81.6lbs / 37kg • Height: 62 in / 157.48 cm (Fully Extended) •...
  • Page 54 Learn more about Erchonia lasers erchonia.com | 1-321-473-1251 US March 2022 OM-HPS2-C Rev 03...

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