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Valeda Light Delivery System User Manual

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User Manual
Light Delivery System

Table of Contents

Questions and Answers:

Valeda Light Delivery System Specifications

General IconGeneral
BrandValeda
ModelLight Delivery System
CategoryMedical Equipment
LanguageEnglish

Summary

Indications for Use

Introduction

Valeda Light Delivery System Description

Valeda Light Delivery System Operation

Disposables

Details the disposable protective barriers for the Valeda system.

Valeda LumiKey

Description of the Valeda LumiKey, a USB storage drive for treatment credits.

Valeda Dust Cover

Information about the Valeda Dust Cover for system protection.

Labelling Symbols

Contraindications for Use

Important Safety Instructions

Warnings

Information relating to potential dangers when using Valeda.

Cautions

Important information to prevent possible harm when using Valeda.

Precautions

Information alerting the operator to exercise special care for safe and effective use.

Information

Useful information related to the operation of Valeda.

Clinical Data

Information related to the clinical safety and efficacy of Valeda.

Installation

Overview

Valeda is intended for use in a controlled room environment at ambient temperature and humidity.

Box Contents

Lists the items included in the Valeda shipping box.

Valeda Setup

Instructions for setting up the Valeda system for patient and operator use.

Operating Instructions

System setup

Steps to set up the Valeda system, including verification and power on.

Patient preparation

Steps for preparing the patient for treatment, including barrier placement and alignment.

Beam alignment procedure

Procedure for aligning the light beam with the patient's eye using the joystick.

Treatment procedure

Details the four phases of the treatment procedure and patient instructions.

Cleaning and storage

Instructions for cleaning and storing the Valeda system after use.

Treatment Pause

Treatment Cancelation

Valeda Treatment Credits

Valeda Will Not Operate Without Treatment Credits

Explains that Valeda requires treatment credits purchased from LumiThera.

Grace Period Treatment Credits

Information on using and enabling grace period treatment credits.

Valeda Settings

Language

Instructions on how to change the system language.

Cleaning

Disposal

Maintenance

CAUTION – Do not attempt to disassemble the system.

Important caution against disassembling the system due to no user-serviceable parts.

Troubleshooting

Record fault message

Instruction to record any system fault messages displayed on the screen.

Reboot system

Suggestion to reboot the system to potentially resolve issues and allow treatment.

Contact LumiThera

Instruction to contact LumiThera for assistance with system faults.

Troubleshooting Guide for Errors and Alarms

Technical Specifications

Glossary

Guidance and Manufacturer's Declarations

Electromagnetic Emissions for All Equipment and Systems

Guidance on electromagnetic emissions and compliance for the Valeda system.

Electromagnetic Immunity for All Equipment and Systems

Electromagnetic Immunity for Equipment and Systems That Are Not Life-Supporting

Radiated RF Immunity

Information on radiated RF immunity and recommended separation distances.