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Sirona SIROLaser Advance User Manual

Sirona SIROLaser Advance
170 pages
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Table of Contents

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Sirona SIROLaser Advance Specifications

General IconGeneral
BrandSirona
ModelSIROLaser Advance
CategoryMedical Equipment
LanguageEnglish

Summary

General Information

Dear Customer

Welcome message and overview of the SIROLaser Advance device.

Contact Data

Contact details for customer service and manufacturer.

General Information on Operating Instructions

Importance of reading instructions and observing safety information.

Intended Use

Details the applications and intended use of the SIROLaser Advance laser device.

Formats and Symbols Used

Explains the meaning of symbols and character formats used in the manual.

Safety Information

Identification of Danger Levels

Explains the meaning of WARNING, CAUTION, and NOTICE highlights.

Standards and Regulations

Lists standards and regulations the SIROLaser Advance complies with.

Operating Personnel

Specifies the qualification and knowledge required for operating personnel.

Physical Working Principle

Explains how the SIROLaser Advance generates and uses laser radiation.

Laser Radiation Hazards

Details laser safety precautions, including eye protection and emergency stop.

Nominal Ocular Hazard Distance

Specifies the NOHD from the optical fiber's distal end.

Laser Protective Goggles

Instructions for using and checking laser protective goggles.

Optical Fiber and Single-Use Tip

Guidance on handling optical fibers, connection sockets, and single-use tips.

Contamination

Warns about cross-contamination and precautions for handling tissue particles.

Installation

Guidelines for installing the SIROLaser Advance, including location and electrical requirements.

Modifications

Emphasizes authorized maintenance, repair, and use of original parts/accessories.

Cellular Phones

Warns about potential interference from mobile RF devices.

System Description

System Overview

Provides a labeled diagram of the SIROLaser Advance control unit and handpiece.

Laser Operation Modes

Explains continuous wave, chopped mode, and peak-pulse mode operations.

Symbols and Abbreviations

Lists and explains various symbols and abbreviations used in the manual.

Technical Data

Details general specifications and SIROLaser Advance specific technical data.

Installation

Scope of Supply

Lists all components included in the SIROLaser Advance package.

Spare Parts

Lists available spare parts with their order numbers.

Labels

Information on applying language-specific labels to the laser unit.

Initial Start-up – Procedure for Proper Assembly

Detailed steps for the initial setup and assembly of the SIROLaser Advance.

Operation

Start the Device for the First Time

Initial steps for powering on and starting the SIROLaser Advance.

Switch on Power

Detailed steps for switching on the SIROLaser Advance and initial setup.

Self Test

Describes the automatic self-test procedure upon booting the device.

Enter Pin Code

Explains how to enter the user pin code for security and access.

Main Home Screen

Overview of the main home screen and its submenus.

Switching Off the Laser Device

Steps for safely switching off the SIROLaser Advance.

Indications, Contraindications, and Medical Precautions

Indications

Outlines the advantages and recommended use of the SIROLaser Advance.

List of Preset Indications

Details preset treatment indications with parameters like power, mode, frequency.

Further Non-Preset Indications

Lists additional indications that can be defined individually.

Examples of Treatment Risk

Identifies potential risks in different treatment areas and countermeasures.

Contraindications

Discusses general medical conditions that may contraindicate laser use.

Cleaning, Disinfection, and Sterilization

Cleaning

Instructions for cleaning the optical fiber, handpiece sleeve, and fibercutter.

Disinfection

Guidance on disinfecting the device and its parts using approved disinfectants.

Sterilization

Specifies sterilization requirements for optical fibers and handpiece sleeves.

Cleaning the Control Unit

How to clean the control unit using a dry or damp cloth.

Maintenance and Service

Safety Checks

Lists safety checks to be performed by a qualified service engineer.

Maintenance

Recommended periodic maintenance actions for the SIROLaser Advance.

Troubleshooting of Simple Defects

Provides steps to diagnose and resolve common malfunctions.

Technical Support, Repair and Testing

Information on obtaining technical support and arranging for repairs.

Replacing the Rechargeable Battery of the Control Unit

Step-by-step guide for replacing the rechargeable battery.

Replacing the Batteries of the Wireless Foot Control

Instructions for replacing the AAA batteries in the wireless foot control.

Replacement of Parts Subject to Wear and Tear

Identifies parts subject to wear and tear and recommended replacement intervals.

Electromagnetic Compatibility

Electromagnetic Emission

Details the RF emissions and compliance for the unit's operation.

Interference Immunity

Lists immunity tests and compliance levels for electromagnetic interference.

Working Clearances

Recommended minimum distances for RF communication devices to prevent interference.

Disposal

Batteries

Instructions for proper disposal of batteries.

Accessories

Guidance on disposing of accessories like fibers and tips.

Appendix

Appendix A – Certification

States compliance with Council Directive 93/42/EEC concerning medical devices.

Appendix B – Label Positions

Shows the locations of labels on the SIROLaser Advance unit.

Appendix C – Safety Circuit (Interlock)

Provides a circuit diagram and explanation for the safety interlock system.

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