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Summary of Contents for Erchonia EVRL
- Page 1 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...
- Page 2 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 EVRL™ for the first time. This symbol appears next to information about possible safety risks.
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Page 3: Table Of Contents
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE TABLE OF CONTENTS SECTION 1 General Information SECTION 3 EVRL™ Operation Powering on device How to Use this Reference Guide What is EVRL™ device EVRL™ Touchscreen Who is the EVRL™ Intended for? Package Contents... -
Page 4: Section 1 General Information
HOW TO USE THIS REFERENCE GUIDE This reference guide is designed to take you through the proper use of your ERCHONIA® EVRL™ device. It will cover the Device Basics, Treatment Protocol, Cautions and Warnings. It is important that you read and understand all of the information contained in this reference guide before doing any treatments with the EVRL™... -
Page 5: Package Contents
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE PACKAGE CONTENTS The EVRL™ is shipped in a carrying case containing the following items: - (1) EVRL™ Handheld device (no assembly required) - (1) Laser Safety Goggles - (1) Charger Base - (1) Charger Base Power Supply Connector When you receive the shipment, carefully inspect the container for damage. -
Page 6: Symbols Used On Equipment
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE SYMBOLS USED ON THE EQUIPMENT Any or all of the following symbols may be used in this reference guide or on the equipment: SYMBOL DESCRIPTION Temperature Limitation Conformité Européenne - Complies with EMC 2004/108/EC and LVD 2006/95/EC. -
Page 7: Conventions
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE CONVENTIONS This reference guide uses the following conventions: Within the text, the names and labels for buttons appear in boldface type (for example, “Press the Start button or press the Stop button”). Warning - alerts you about a situation which, if not avoided, could Warning result in death or serious injury. -
Page 8: Caution
There are no user-serviceable parts inside the device. If a malfunction occurs, discontinue use immediately and contact Erchonia Corporation for repair service. DO NOT permit any foreign materials or liquids to enter the device. Take care to prevent any foreign materials including, but not limited to, inflammables, water, and metallic objects from entering the device. -
Page 9: Warning
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE WARNING Read all instructions for operation before using the device. DO NOT use if you are pregnant or think you may be pregnant. DO NOT use if you are being treated for any cancerous growths on or around your feet DO NOT use if you have open wounds (sores, cuts, ulcers, etc.) around your feet. -
Page 10: Section 2 Evrl™ Overview
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE Section 2: EVRL™ DEVICE OVERVIEW DIAGRAM OF MACHINE 1. Power Button (ON/OFF) 2. Laser ON Light 3. Power ON Light 4. Touch Screen 5. Pivoting Laser Mount 6. Laser Diodes Covered Micro USB (For Manufacturer Use Only) Note: No Assembly is required, device is shipped ready for use. - Page 11 ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE LABELS The device is manufactured in accordance to the Good Manufacturing Practices set forth by the FDA, ISO Standards (International) and CE (Conformité Européenne or European Conformity) standards and testing results per Article 9. The device is a Class I Shock Protection and a Class II Medical device.
- Page 12 RISK AND BENFITS The EVRL™ works by using a patented and clinically proven low-level laser technology. The EVRL™ laser lights promote local blood flow in the foot to activate repair mechanisms and produce anti-inflammatory properties to reduce nerve irritation and inflammation in the foot to provide pain relief.
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Page 13: Protective Eyewear
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE PROTECTIVE EYEWEAR o EVRL™ is classified by the FDA/IEC as a Class 2 laser device. This represents a current standard for use in order to ensure the safety of the patient. o A Class 2 laser is determined to have a chronic viewing hazard. -
Page 14: Section 3 Evrl™ Operation
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE EVRL™ OPERATION Powering ON the device To power on the EVRL™ device press and hold the Power Button (item #1) for 3 seconds until the “POWER ON” light illuminates green light. ITEM #1 Once the device is powered ON, the loading screen will display for 30-45 seconds. - Page 15 ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE Password Screen STEP #1 “Passcode Screen” Enter the passcode “1234” (factory set code), then press the “SIGN IN” icon. Function Screen STEP #2 “Function Screen” “Mode Select” icon “Settings” icon: Not used in this clinical trial.
- Page 16 “Neuropathy Treatment Screen” Neuropathy Treatment Screen The following functions are available on this screen: “START” icon will begin the EVRL™ treatment. “PAUSE” If for any reason you need to pause the treatment during a session, press the “PAUSE” icon. To resume with procedure, press the “PAUSE” icon again.
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Page 17: Treatment Protocol
7. Hold the EVRL™ at distance of approximately 3 to 6 inches from the skin surface throughout the entire 5-minute treatment. During the treatment hold the laser stationary (no sweeping motion necessity). -
Page 18: Powering Off Device
Fig 1. Treatment Fig 2. Treatment Close Up The Erchonia® EVRL™ treatment will run for 5 continuous minutes and will stop once treatment time is at 0:00. Once the “Time Remaining” display reaches 0:00 the treatment is complete, the laser lights and the laser indicator light will turn off. -
Page 19: Recharging The Battery
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE RECHARGING THE BATTERY The Erchonia® EVRL™, fully charged will operate continuously for approx. 4 to 5 hours depending upon use. The device has a battery indicator on the touch screens which informs you of the status of the battery charge. -
Page 20: Section 4 Maintenance & Warranty
Technical Information Technical documentation required by the customer, in case of necessary reparations, will be provided by Erchonia in the US and our EU agent, internationally. These documents will be supplied once the manufacturer makes the determination that the requested documents do not constitute a disclosure of proprietary or patent protected information and are a part of the filed and documented technical file. -
Page 21: Maintenance And Cleaning
ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE MAINTENANCE & WARRANTY INFORMATION MAINTENANCE The Erchonia® EVRL™ 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. -
Page 22: Laser Optics Cleaning
WARRANTY LIMITED WARRANTY The Erchonia® EVRL™ device is warranted to be free from defect in material and workmanship for a period of TWO YEARS from the date of purchase. For your device to be processed through the Service and Repair Department efficiently, contact the department prior to submitting your product. - Page 23 ERCHONIA® EVRL™ PROPER USE REFERENCE GUIDE Congratulations on completing the Erchonia® EVRL™ Proper Use Reference Guide. You are now ready to use the Erchonia® EVRL™ Page 20...
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