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Erchonia EVRL - User Manual

Erchonia EVRL
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ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE
ERCHONIA® EVRL™
PROPER USE REFERENCE GUIDE
Prescription Home Use Device
Prescription Home Use / Non-invasive Laser
Read this entire guide before using your EVRL
device

Questions and Answers

Summary

Getting Started: Read This First

Safety and Support Information

Important safety warnings and contact details for Erchonia customer care and support.

General Information About EVRL

Guide Navigation Instructions

Guidance on navigating and understanding the structure and content of the reference manual.

EVRL Device Definition and Use

Defines the Erchonia EVRL device and its primary indication for use in treating foot pain.

Target Users for EVRL Device

Specifies the target demographic and medical requirements for using the EVRL device.

EVRL Package Contents

Included Device Components

Lists all items provided with the Erchonia EVRL device, including the handheld unit and accessories.

EVRL Equipment Symbols

Symbol Meanings and Hazards

Explains various symbols found on the EVRL device and in the manual, detailing their meaning and associated risks.

Document Conventions and Terms

Understanding Manual Conventions

Defines the conventions used in the manual, including bold text for controls and explanations of warning/caution statements.

EVRL Device Safety Precautions

General Usage Cautions

Lists important precautions to prevent damage to the device or injury, such as avoiding sharp objects on the screen.

Critical EVRL Safety Warnings

Mandatory Safety Alerts and Restrictions

Details critical warnings regarding device use, including contraindications, environmental hazards, and electrical safety.

EVRL Device Component Overview

EVRL Machine Diagram and Parts

Provides a visual diagram and list of all parts of the EVRL device, including the power button, screen, and laser mount.

EVRL Device Labels and Compliance

Understanding Device Labeling

Explains the compliance label and serial number placement on the EVRL device, referencing manufacturing standards.

EVRL Therapy Risks and Benefits

Potential Risks and Side Effects

Outlines the known or anticipated risks associated with EVRL laser use, primarily focusing on potential eyesight damage.

EVRL Therapeutic Benefits

Briefly mentions the benefits of EVRL therapy, referencing clinical trial results that will be listed elsewhere.

EVRL Protective Eyewear

Essential Safety Glasses Usage

Details why protective eyewear is crucial for EVRL use, explaining the Class 2 laser hazard and the function of the provided safety glasses.

EVRL Device Operation Guide

Powering On the EVRL Device

Step-by-step instructions on how to turn on the EVRL device, including button press duration and indicator lights.

EVRL Interface Navigation

EVRL Touchscreen Interaction

Describes the interactive touch screen as both a display and input panel for operating the device.

Device Access: Passcode and Mode Selection

Guides users through entering the passcode and selecting the appropriate treatment mode via the touchscreen interface.

EVRL Treatment Initiation

Selecting Neuropathy Treatment Mode

Instructs users on how to navigate to and select the 'Neuropathy' mode for treatment.

Treatment Screen Controls: Start, Pause, Stop

Explains the functions of the Start, Pause, and Stop buttons on the treatment screen for managing therapy sessions.

EVRL Treatment Protocol Details

EVRL Treatment Schedule and Duration

Outlines the recommended treatment plan, including the total number of treatments and their distribution over three weeks.

Step-by-Step Treatment Administration

Provides a detailed, step-by-step guide on how to perform a single EVRL treatment session, including device positioning and duration.

Completing EVRL Treatments

End of Treatment Procedures

Explains what happens when a treatment session ends automatically and how to repeat for the other foot.

Proper EVRL Device Power Off

Provides instructions on how to properly shut down the EVRL device after use, including the prompt for powering down.

EVRL Battery Management

Understanding Battery Status

Describes the device's battery life and how the battery indicator on the screen displays charge status.

EVRL Device Recharging Guide

Offers detailed instructions for connecting the charger base and power supply to recharge the device, including indicators.

EVRL Maintenance and Support

Technical Documentation for Repairs

Explains how technical documentation for repairs is provided by Erchonia and its conditions.

Service, Repair, and Return Process

Details how to contact the Erchonia Service and Repair Department, information needed, and how to return a device for service.

EVRL Routine Maintenance

Regular Maintenance Tasks

Lists regular maintenance activities for the EVRL device, including visual inspections and cleaning frequency.

Cleaning EVRL Device Surfaces

Provides specific instructions on how to clean the external surfaces and touch screen of the EVRL device safely.

EVRL Optics, Warranty, and Troubleshooting

Cleaning EVRL Optics and Glasses

Specifies the correct method for cleaning the laser optics and safety glasses to maintain performance.

EVRL Limited Warranty Details

Outlines the two-year limited warranty for the EVRL device, including what is covered and what is excluded.

Overview

The Erchonia® EVRL™ is a prescription home-use, non-invasive laser device designed for adjunctive use in providing temporary relief of diabetic peripheral neuropathy foot pain in previously diagnosed individuals aged 18 years or older. This device utilizes patented and clinically proven low-level laser technology to promote local blood flow in the foot, activating repair mechanisms and producing anti-inflammatory properties to reduce nerve irritation and inflammation, thereby providing pain relief.

Usage Features:

The EVRL™ device is straightforward to operate, with a user-friendly touchscreen interface. To power on the device, the user presses and holds the Power Button (labeled as item #1 in the diagram) for 3 seconds until the "POWER ON" light illuminates green. After powering on, a loading screen will display for 30-45 seconds before the device is ready for use.

The touchscreen serves as both a display for information and an input panel for operating the device. Users should exercise caution not to use sharp objects like pencil points or ballpoint pens on the touchscreen, as this may cause damage. Abrasives, including paper towels, should also be avoided when cleaning the screen.

To begin a treatment, the user first enters a passcode (the factory set code is "1234") on the "Passcode Screen" and then presses the "SIGN IN" icon. From the "Function Screen," the user selects the "Mode Select" icon (ITEM #2). On the subsequent "Mode Select Screen," the "User Protocol Mode" icon (ITEM #3) is chosen. Finally, on the "User Protocol Mode Screen," the "Neuropathy" icon (ITEM #4) is pressed to access the "Neuropathy Treatment Screen."

Before starting treatment, it is crucial to put on the provided laser safety goggles to protect the eyes from laser light energy. The EVRL™ is classified by the FDA/IEC as a Class 2 laser device, indicating a chronic viewing hazard if the laser beam is pointed directly into the eye for an extended period. Therefore, proper use of the safety glasses is mandatory. Users should also remove any shoes and socks before treatment.

Once on the "Neuropathy Treatment Screen," the "START" icon initiates the EVRL™ treatment. The device is preprogrammed to treat for a total of 5 minutes. The treatment time display will count down automatically, and the lasers will power off when the display reaches 0:00. During the 5-minute session, the EVRL™ device should be held stationary at a distance of approximately 3 to 6 inches from the skin surface, aiming over the top of the foot with the laser beams emitting lengthwise in the same direction as the foot. The laser lights are designed to cover the top of the ankle to the end of the toes.

The treatment protocol requires administering 42 treatments over 3 weeks, meaning 2 treatments per day for 3 consecutive weeks. Each treatment session involves a 5-minute application to each foot. After the 5-minute treatment on one foot, steps 4-7 of the protocol are repeated for the opposite foot. Once both feet have been treated, the session is complete, and the safety glasses can be removed.

The "Neuropathy Treatment Screen" also includes "PAUSE" and "STOP" icons. The "PAUSE" icon allows the user to temporarily halt the treatment during a session and resume it later by pressing "PAUSE" again. The "STOP" icon will completely reset the treatment time if pressed.

To power off the device, the user presses and releases the Power Button (ITEM #1) from any screen. This action prompts the "Power Down Device Screen," where the "Power Down Device" icon is touched. The "Powering Down Screen" will then display until the device properly shuts down.

Maintenance Features:

Proper maintenance ensures the EVRL™ laser operates efficiently for years. Users are advised to perform routine visual inspections and cleaning.

Routine User Maintenance:

  • Clean the external surfaces of the device: Weekly, or as needed, using a cloth dampened with a non-caustic cleaning solution such as mild soap and water, isopropyl alcohol, or a "hospital-grade" disinfectant. The device should then be dried with a clean cloth or allowed to air dry. It is crucial not to permit any foreign materials or liquids to enter the device, as this can cause damage, malfunction, electrical shock, fire, or personal injury. To protect against spilled or splashed liquids, the device should be unplugged from the power supply and thoroughly dried before operation.
  • Clean the touch screen display: Weekly, or as needed, by applying an alcohol-based cleaner to a soft cloth. Cleaning agents should not be sprayed or poured directly onto the device or touchscreen to avoid damaging the console, touchscreen, and system electronics.
  • Clean laser optics: Weekly, or as needed, using only lens paper or a lens cloth. Abrasive materials could cause laser light beam fragmentation, reducing treatment effectiveness.
  • Clean Laser glasses: Between each patient use, using only mild soap.

General Maintenance and Inspection:

  • Regular visual inspections: Check for any external damage beyond normal wear and tear. Inspect the Touch Screen for cracks or malfunctions. If any concerns are identified, the manufacturer should be contacted.
  • Performance changes: If a change in device performance is noticed while it is ON, contact the manufacturer.
  • Internal components: Internal components do not require user maintenance. If an issue arises that alters performance, the device must be sent to the manufacturer for service.
  • Charger Base and Power Supply: Inspect the Charger Base and Power Supply for signs of damage (e.g., cuts in insulation or fraying). Replace if damaged.

Recharging the Battery:

The EVRL™ device, when fully charged, can operate continuously for approximately 4 to 5 hours, depending on usage. A battery indicator on the touchscreen displays the charge status. When the battery meters show a low charge, the device needs to be recharged immediately. To recharge:

  1. Plug the Power Supply Connector into the Charger Base Connector Port.
  2. Connect the detachable Power Supply Cord into the Power Supply, then insert the Power Supply cord into a 110-220V electric outlet. The charger base power light will illuminate and remain lit if connected correctly.
  3. Place the laser device onto the Charger Base with the touchscreen facing up and lasers facing away from the Charger Base LED lights. The docked light on the charger base will turn ON if the device is docked correctly.
  4. For a full charge, leave the laser device on the charger base for at least 2.5 hours continuously. While charging, the docked light on the Charger Base will flash ON and OFF. The battery indicator meter on the touchscreen will show the charge status, displaying full bars when fully charged.
  5. Docking the laser device between uses is recommended, and shorter charging periods are possible.

The battery is an internal, non-accessible unit and can only be replaced by the manufacturer. The EVRL™ contains a unique battery system designed for consistent power delivery and portability. The internal battery is sealed by the vendor and encased within the device housing. The external power supply used with the charger base is an IEC 60601 3rd Ed. certified unit. If the power supply is lost or damaged, a replacement can be purchased from Erchonia Corporation. A warning is issued regarding the battery: mistreatment (disassembly, heating above 100°C (212°F), or incineration) may present a risk of fire or chemical burn. The manufacturer should be contacted for battery replacement, as using another battery may pose a risk of fire or explosion.

Troubleshooting:

A troubleshooting guide is provided to help resolve common issues:

  • Device does not power on: Possible cause is that it may not be charged. To resolve, recharge the device for 2.5 hours by placing it in the inductive charger base.
  • Charge base indicator lights do not come on when device is docked: Possible cause is that the device may be placed incorrectly in the charge base or the power supply is not plugged in correctly. To resolve, place the device in the charger base with the touchscreen facing up and the laser heads in the opposite end of the charger base indicator lights.
  • Device is not responding: Possible cause is that the internal computer may need to be reset. To resolve, hold the ON/OFF button down until the device powers off, then restart it.

For any difficulties operating the device after reviewing the guide, or for service and repair inquiries, customers can contact Erchonia Customer Care. When requesting service, provide the device serial number, a description of the problem, and contact information. For returning a device for service, an SO (service order) number must be obtained from the service representative, and the device should be packed in its original or equivalent packaging with the SO number clearly marked on the package.

Erchonia EVRL Specifications

General IconGeneral
Laser ClassClass 2
Laser TypeLow-Level Laser
FDA ClearanceYes
Power SourceAC Adapter
Laser Wavelength635nm
Laser Power5mW
ModulationContinuous Wave
Output Power10 mW
Treatment DurationVaries depending on protocol

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