SCHWIND Amaris 500E - Protective Measures of the Manufacturer; Conformity with Safety Standards

USER MANUAL (Instruction for Use) SW 6.1
Safety
Version 6.1.6 dated 2020-01-31 EN Page 23 of 201
2.4.2 Protective Measures of the Manufacturer
The necessity for personal protection measures of the user against dangerous effects from the
AMARIS laser are reduced to a minimum through various measures undertaken by SCHWIND
eye-tech-solutions during the manufacturing process of the excimer laser system.
The most important measures are:
Technical design of the excimer laser with integrated safety features, such as:
 Enclosure of the beam.
 Guard against accompanying radiation.
 Mounting of control equipment and control features on the laser housing so that
switching on and operating the equipment can be carried out without danger of the laser
beam exceeding radiation units.
 An EMERGENCY STOP SWITCH „Laser Stop“ for immediate stopping the laser (refer to
chapter 6.6 Control Panel of the Excimer Laser).
 Posting of appropriate warning signs on the equipment against visible and invisible laser
radiation (refer to chapter 2.9 Device Labelling).
 Appropriate warning references in the laser software which appear on the screen during
laser operation.
Organizational Measures, such as:
 Classification of the AMARIS laser (refer to chapter 4.5 Laser Classification).
 Training courses for user personnel (refer to chapter 2.4.1 Training of User and Operating
Personnel).
 Start-up of the AMARIS laser through SCHWIND service technicians (refer to chapter 5.5
Initial Installation / Start-Up).
 Maintenance and service (regular TSC controls) (refer to chapter 10.6 Technical Security
Check (TSC).
 Support of the operator and user by the service department of SCHWIND eye-tech-
solutions (refer to GENERAL INFORMATION – Technical Assistance);
 Warranty for the laser systems.
 Providing of equipment documentation as listed in chapter 1.4 Scope of Documentation
 Scope of Documentation with safety notes in the User Manual.
 Conformity with the Safety Standards (refer to chapter 2.4.3 Conformity with Safety
Standards).
2.4.3 Conformity with Safety Standards
Laser Safety
The SCHWIND AMARIS excimer laser, as a medical laser device, corresponds with the safety
requirements of IEC 60601-2-22, "Standard for Medical Lasers" and IEC 60825-1 ”General
Standard for Laser Safety".