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ROCAMED SIRIUS - User Manual

ROCAMED SIRIUS
68 pages
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Thulium Fiber Laser
User Manual
DGM001519.01
Rev. data 19/10/2021

Table of Contents

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Summary

1 General Information

1.1 Introduction

Overview of the Sirius Thulium Fiber Laser system, its wavelength, and surgical applications.

1.2 Purpose of the Manual

Explains the essential information for installation, operation, and maintenance of the Sirius device.

1.3 Safety Instructions

Instructions to prevent injuries, damage, and faults, distinguishing between WARNING and CAUTION symbols.

1.4 Symbols and Abbreviations

Explains symbols and abbreviations used throughout the manual for clarity and understanding.

1.5 Manufacturer

Identifies the manufacturer (Quanta System) and distributor (Rocamed) of the Sirius laser device.

1.6 Combinations

Recommends using Rocamed-distributed fibers and warns about potential risks of incorrect product combinations.

2 Laser Safety

2.1 General Safety

General safety rules and precautions for operating the Sirius laser device safely and effectively.

2.3 System Safety Features

Details built-in safety features like footswitch control, circuit breaker, and interlocks for safe operation.

2.6 Eye and Skin Exposure

Explains the risks of laser exposure to eyes and skin and outlines necessary protective measures.

2.8 Fire Hazard

Discusses potential fire hazards associated with laser treatment and outlines necessary precautions.

2.9 Emission of Plume

Addresses concerns about biological plume generated by laser and recommends using a smoke evacuator.

2.13 Labelling Plan

Illustrates various labels on the device and their meanings for identification and safety.

Device Front View Labels

Details the labels and components visible on the front panel of the laser device.

Device Rear View and Footswitch Labels

Identifies labels and components on the rear panel and the footswitch.

3 Device Description

3.1 Introduction

Introduces the Sirius Laser System, its wavelength, maximum power, and fiber optic delivery system.

3.2 General Description of the Device

Provides an overview of the device and its main parts, including a labeled diagram.

3.3 Electrical Control

Explains the electrical controls including mains switch, key switch, and emergency push button.

3.4 Accessories

Lists optional accessories associated with the device and refers to Chapter 11 for details.

4 System Installation

4.1 Device Installation

Outlines requirements and procedures for installing the laser device safely and correctly.

4.6 Installation Procedure

Provides a step-by-step guide for installing the device, including checks and user training.

4.6.2 Remote Interlock Connection

Explains the connection of the remote interlock for safety, preventing emission when doors are open.

5 Instructions for Use

5.1 Start-up Procedure

Guides users through the initial steps to power on the Sirius device safely.

5.2 Operating Instructions

Provides instructions on how to operate the Sirius device using its main display screen.

5.2.1 Main Screen

Details the layout and functions of the main display screen interface for device operation.

5.3 Settings

Outlines the available settings including aiming beam, brightness, sound, language, and device info.

5.4 Laser Emission

Guides users on how to start laser emission after setting working parameters.

5.5 Error and Warning Description

Lists and describes errors and warnings displayed on the control panel for troubleshooting.

5.6 Shutdown Procedure and Protection Against Unauthorized Use

Provides steps for safely shutting down the device and preventing unauthorized access.

6 Clinical Application

6.1 Intended Use

Specifies who the Sirius laser is intended for and its approved surgical applications.

6.2 Treatment Parameters and Instructions

Discusses parameters and provides instructions for using the Sirius laser for various treatments.

6.2.1 Treatment Parameters and Instructions for Endoscopic Procedures

Details parameters and techniques for endoscopic procedures in urology and other specialties.

6.2.2 Treatment Parameters and Instructions for Open Surgery & Laparoscopic Procedures

Details parameters and techniques for open surgery and laparoscopic procedures.

6.3 General Laser Warnings

Lists general warnings and precautions applicable to all surgical specialties using the laser.

6.5 General Laser Complications

Discusses potential complications and adverse reactions that may occur from laser surgery.

6.6 Contraindications for Laser Surgery

Lists general contraindications for using the laser system based on patient conditions.

7 Maintenance, Cleaning and Sterilization

7.1 Device Cleaning

Provides instructions for cleaning the laser device surfaces safely and effectively.

7.2 Laser Maintenance and Technical Check

Recommends regular check-ups by qualified technicians for optimal safety and performance.

7.5 Optical Fiber Maintenance

Covers fiber sterilization, usage instructions, and maintenance for proper functioning.

7.6 Blast Shield Replacement

Guides on checking and replacing the blast shield if it shows signs of damage.

8 Troubleshooting

9 Customer Service

9.1 Manufacturer Warranty and Responsibility

Defines manufacturer warranty terms, coverage, and responsibilities for the Sirius system.

9.2 Repairs and Modifications of the Device

Outlines procedures for authorized repairs and prohibits unauthorized modifications.

9.3 Service Department Contacts

Provides contact information for Rocamed's service department for assistance.

10 Technical Specifications

10.1 General Specifications

Lists general specifications of the Sirius laser device, including classification, dimensions, and weight.

10.2 Laser Source Specifications

Details laser source specifications like type, wavelength, maximum power, and pulse energy.

11 Accessories

12 Appendix A: RMA Request

13 Appendix B: EMC Tables

14 Appendix C: Logbook

ROCAMED SIRIUS Specifications

General IconGeneral
BrandROCAMED
ModelSIRIUS
CategoryMeasuring Instruments
LanguageEnglish