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SCHWIND Amaris 1050RS User Manual

SCHWIND Amaris 1050RS
201 pages
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SCHWIND eye-tech-solutions GmbH Mainparkstrasse 6-10 · 63801 Kleinostheim GERMANY
0483
USER MANUAL (Instruction for Use) TREAT
Original version
Excimer Laser

Table of Contents

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SCHWIND Amaris 1050RS Specifications

General IconGeneral
Wavelength193 nm
Pulse Frequency/Repetition Rate1050 Hz
Aperture SizeVariable
Treatment Speed1.3 seconds per diopter
Spot Size0.54 mm
Ablation TimeDependent on correction
Eye Tracker6-dimensional eye tracking system
FluenceVariable
Treatment TimeDependent on correction
ApplicationsRefractive surgery, LASIK, PRK
Laser TypeExcimer laser
Pulse EnergyVariable
Pulse DurationVariable

Summary

General Information

System Identification Data

Details about the product name, device description, class, and manufacturer.

Symbols for Warnings, Precautionary Measures and Notes

Explanation of symbols used in the manual for warnings, cautions, and notes.

Liability of the Manufacturer

Manufacturer's disclaimer regarding product use, negligence, and unauthorized modifications.

Warranty Information

Details on the warranty period, coverage, and exclusions for the AMARIS system.

Safety Precautions and Procedures

General Safety Notes

General instructions for proper and safe operation of the SCHWIND AMARIS.

Regulations for Medical Devices

Overview of applicable medical device regulations and directives for safe use.

Restrictions of Use and Safety Precautions

Measures to reduce risks associated with laser radiation and other hazards.

Operator's Responsibility

Key responsibilities of the operator for ensuring patient and device safety.

Dangers Resulting from Laser Operation

Potential hazards associated with laser operation, including radiation and gas exposure.

Electrical Safety - Connection of Devices to External Plugs

Guidelines for safe connection of external devices to the AMARIS laser.

Device Labelling

Explanation of identification labels, symbols, and connection terminal labels.

Introduction to SCHWIND AMARIS

Intended Use

Description of the AMARIS excimer laser's medical applications in refractive surgery.

Contraindications and Side Effects

Lists absolute and relative contraindications and potential side effects of laser surgery.

Residual Risks

Identifies potential risks associated with treatments using AMARIS lasers.

Device and System Description

System Overview

Lists the main components of the SCHWIND AMARIS excimer laser system.

System Description

Details the design and operational features of the AMARIS 750S/1050RS and 500E models.

Laser Classification

Details the classifications of the excimer, aiming, cross, and OCP lasers used.

Microscope and Illumination

Description of the operating microscope and its illumination system.

Particle Aspiration System

Function and maintenance of the system for removing surgical particles.

Plume Evacuation System

Details on the system for debris removal and plume evacuation during surgery.

Optional Features

Overview of optional components like Video System, Printer, and Eye Tracking.

Installation Procedures

General Installation Notes

Important safety and procedural notes for installing the AMARIS laser system.

Room and Installation Requirements

Guidelines for environmental conditions, room setup, and door specifications.

Device and Room Dimensions

Diagrams and measurements for device placement and room requirements.

Environmental Conditions

Specifies required air, temperature, and humidity conditions for operation and storage.

System Software Requirements

Details on software compatibility and installation requirements for AMARIS and CAM.

Shipping and Handling

Information on scope of delivery, packing, transport configurations, and damages.

Initial Installation / Start-Up

Procedures for system setup, connection, and user training by authorized personnel.

Device Control and Operation

General Operation Notes

Basic guidelines for operating the AMARIS excimer laser safely.

Control System Overview

Description of the device's control system including keyboard, touch pad, and monitor.

Emergency Stop Switch

Location and operation of the emergency stop button for immediate system shutdown.

Switching the Device ON and OFF

Step-by-step instructions for powering the AMARIS system on and off.

UPS - Mains Failure or Power Breakdown

Procedures for handling power loss and UPS operation.

Control Panel Functions

Explanation of the controls on the excimer laser's panel, including magnification and laser controls.

Operating the Microscope

Instructions for adjusting magnification, focus, and eyepieces of the operating microscope.

Software Managed Operation

Guide to user login, password input, and main menu navigation.

Service Procedures and Functions

Functions Menu Options

Overview of available functions like TAM, Settings, User Accounts, and Credit Code.

Registration and User Accounts

Procedure for creating, managing, and deleting user accounts.

Settings Menu Configuration

Adjustments for treatment printout, units, OCP, and display settings.

Credit System Management

Details on managing treatment credits, importing files, and viewing credit overviews.

Treatment Assistant Manager (TAM)

Tool for standardizing surgical procedures and pre-setting treatment steps.

Software Update Procedure

Instructions for performing system software updates using provided files.

Fluence Measurement and Testing

Procedures for calibrating the system using fluence measurement and detector connection.

Drift Test Procedure

Steps for performing a drift test to compensate for optical system drifts.

Gas Exchange - Excimer Laser

Procedure for changing the excimer laser gas supply and troubleshooting gas issues.

Export Log File and Treatment Data

How to copy and forward system log files and treatment data for analysis.

Printout and Video Export

Options for printing, exporting, or displaying treatment PDFs and videos.

Treatment Printout Details

Information on the content and format of treatment printouts.

Treatment Selection and Planning

General Treatment Selection

Overview of selecting new, imported, or recovered treatments from the main menu.

Planning SCHWIND CAM Treatments

Guide to planning new treatments using SCHWIND CAM software modules.

Performing SCHWIND CAM Treatments

Steps for executing a planned treatment via the AMARIS software.

Recovery Function for Aborted Treatments

Procedure for recovering and continuing treatments that were previously aborted.

Eye Tracking System Operation

Explanation of the eye tracking system for compensating eye movements during ablation.

Online Coherence Pachymetry (OCP)

Functionality for measuring corneal thickness during treatment.

Timer Functionality

Using the timer as a tool for specific applications during treatment steps.

Cleaning and Maintenance Procedures

General Cleaning and Maintenance Notes

Essential safety warnings and precautions for cleaning and maintaining the device.

Cleaning of Non-Sterile Parts

Manual cleaning procedures for various AMARIS components.

Cleaning of Excimer Laser Housing

Specific instructions for cleaning the laser unit's external housing.

Cleaning of the Patient Bed

Guidelines for cleaning the patient bed, including safety warnings.

Cleaning of Microscope and Optical Components

Procedures for cleaning the operating microscope and related optical parts.

Cleaning of the Laser Beam Aperture Area

Instructions for cleaning the aperture area and eye tracking components.

Reprocessing of Re-sterilisable Parts

Information on sterilizing specific parts like pens and microscope caps.

System Maintenance and Troubleshooting

General Maintenance Notes

User limitations and safety protocols for maintenance tasks.

Troubleshooting Operating Microscope Issues

Common issues with the microscope and their remedies.

Maintenance of the Particle Aspiration System

Procedure for replacing the particle aspiration system nozzle.

Maintenance of the Plume Evacuation System

Guidelines for replacing the plume evacuation system nozzle.

Technical Security Check (TSC)

Information on mandatory annual technical safety inspections.

Components and Consumables List

List of optional components and consumables with article numbers.

Product Life Expectancy and Service Life

Details on expected service life and wear part availability.

Disposal Guidelines

Instructions for proper disposal of the laser device and its components.

Technical Data Specifications

Appendices and Technical References

Backup Batteries Information

Details on backup batteries used in Panel PCs and embedded PCs.

Nomogram Definition and Age Factors

Explanation of nomogram files and age-based profile adjustments.

Electrical Safety Parts

List of electrical safety components and their specifications inside the AMARIS.

EMC Guidance and Manufacturer’s Declaration

Information on electromagnetic compatibility and interference guidelines.

Essential Performance Standards

Essential performance criteria and protective measures against EM disturbances.

List of Replaceable Cables and Components

Table of cables and components affecting EMC compliance.

Manufacturer Support and Contact Information

Related product manuals