ROCAMED SIRIUS - 14 Appendix C: Logbook

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DGM001519.01 UM Sirius CE/ROTW

ƉƉĞŶĚŝǆ>ŽŐďŽŽŬ

Diario / Logbook

Data

Date

# Colpi

# Shots

Operazioni Eseguite

Operations Done

Firma

Signature

Collaudo Finale / Final Test

Main Page

Table of Contents4
General Information7
Introduction7
Purpose of the Manual7
Safety Instructions7
Symbols and Abbreviations8
Manufacturer10
Combinations10
Laser Safety11
General Safety11
Classification11
System Safety Features11
Training of the Medical Staff11
Working Area12
Eye and Skin Exposure12
Nominal Ocular Hazard Distance13
Environmental Conditions13
Electrical Connection Requirements14
Temperature and Humidity14
Minimum Space Requirements14
Fire Hazard14
Emission of Plume14
Emission of Toxic Gas or Vapor15
Safety Features for the Electromagnetic Compatibility (Emc)15
Warning and Instructions for the Device Disposal15
Labelling Plan15
Front View17
Rear View18
Footswitch18
Device Description19
Introduction19
General Description of the Device19
Electrical Control20
Mains Switch20
Key Switch20
Emergency Red Push Button20
Frontal Button ON/OFF21
Equipotential Connector21
Accessories21
Optical Fiber21
System Installation22
Device Installation22
Transportation22
Packaging22
Inspection22
Labelling Check22
Installation Procedure23
Mains Connection24
Remote Interlock Connection24
Footswitch Connections25
Optical Fiber Connection25
Optical Fiber Check25
Instructions for Use26
Start-Up Procedure26
Operating Instructions27
Main Screen27
Settings31
Brightness31
Sound32
Language32
Database34
Laser Emission35
RFID Fiber Connection35
Ready / Standby35
Ready Mode36
Emission36
Laser Parameters37
Error and Warning Description37
Shutdown Procedure and Protection against Unauthorized Use39
Mains Disconnection39
Clinical Application40
Intended Use40
Treatment Parameters and Instructions42
Treatment Parameters and Instructions for Endoscopic Procedures42
Treatment Parameters and Instructions for Open Surgery & Laparoscopic Procedures45
General Laser Warnings46
General Laser Precautions48
Urology Precautions and Warnings48
Precautions and Warnings in Other Medical Specialties48
General Laser Complications49
Complications for Urology50
Complications in Other Medical Specialties50
Contraindications for Laser Surgery51
Specific Precautions and Contraindications51
Maintenance, Cleaning and Sterilization54
Device Cleaning54
Laser Maintenance and Technical Check54
Safety Labelling Check54
Check of the Line Cable54
Optical Fiber Maintenance54
Fiber Management (Application Cycles)55
Check the Optical Fiber before Operation55
Use, Cleaning, Disinfection, Sterilization of Optical Fibers55
Blast Shield Replacement55
Troubleshooting57
Customer Service59
Manufacturer Warranty and Responsibility59
Repairs and Modifications of the Device59
Service Department Contacts60
Reporting of Serious Incidents60
Technical Specifications61
General Specifications61
Laser Source Specifications62

ROCAMED SIRIUS - 14 Appendix C: Logbook

Table of Contents