SCHWIND Amaris 1050RS User manual

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

USER MANUAL (Instruction for Use)
General Information
Version 6.1.6 dated 2020-01-31 EN Page 2 of 201
Dear Customer
Thank you very much for purchasing this medical product and the confidence you have in our
company. You have decided on a sophisticated product, which was manufactured and tested
under strict quality criteria.
Construction and production fully complies with regulations and requirements which apply to
medical products.
Compliance with all effective standards and laws is clearly visible by the CE symbol, which is
displayed on the identification label. The CE Symbol stands for conformity with current laws and
consequently for security and confidence.
0483
Constant research and development may cause changes in design and scope of supply.
Therefore, in individual cases, the figures in this manual might deviate from the delivered
product.
If you have any questions or desire further information about your equipment, please do not
hesitate to contact us via phone, fax or e-mail. Our team of specialists will be glad to help you.
Our address, phone and fax numbers, as well as the e-mail address can be found at the beginning
of this manual in chapter GENERAL INFORMATION.
Sincerely,
SCHWIND eye-tech-solutions GmbH
IMPORTANT NOTE
Until February 2017, the SCHWIND AMARIS (and likewise all other products
mentioned herein) has been placed on the market under the company name
“SCHWIND eye-tech-solutions GmbH & Co.KG” (with identical address).

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Content
Dear Customer ......................................................................................................................2
Content 3
List of Figures......................................................................................................................10
List of Tables .......................................................................................................................13
1 GENERAL INFORMATION...............................................................................14
1.1 System Identification Data ........................................................................14
1.2 Symbols for Warnings, Precautionary Measures and Notes ..................15
1.3 Notes on the User Manual .........................................................................15
1.4 Scope of Documentation ...........................................................................16
1.5 Declaration of Manufacturer......................................................................16
1.6 Liability of the Manufacturer .....................................................................17
1.7 Warranty......................................................................................................18
1.8 License Agreement.....................................................................................19
1.9 Copyright.....................................................................................................19
1.10 Trademarks .................................................................................................19
2 SAFETY ............................................................................................................20
2.1 General Safety Notes .................................................................................20
2.2 Regulations for Medical Devices ...............................................................20
2.3 Restrictions of Use and Safety Precautions .............................................21
2.4 Manufacturer’s Responsibility...................................................................22
2.4.1 Training of User and Operating Personnel ..........................................................22
2.4.2 Protective Measures of the Manufacturer............................................................23
2.4.3 Conformity with Safety Standards.......................................................................23
2.5 Operator’s Responsibility...........................................................................25
2.5.1 Patient Safety ........................................................................................................25
2.5.2 Device Safety.........................................................................................................26
2.5.3 Electrical Safety.....................................................................................................26
2.5.4 Patient Bed Interlock .............................................................................................27
2.5.5 Laser Warning Lamp and Door Interlock .............................................................27
2.5.6 Protective Glasses .................................................................................................28

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2.5.7 Protective Clothing................................................................................................28
2.5.8 Data and Virus Protection .....................................................................................29
2.5.9 Data Input ..............................................................................................................29
2.5.10 Protection from Data Loss ....................................................................................29
2.5.11 Protection from Unauthorized Use.......................................................................30
2.6 Dangers Resulting from Laser Operation .................................................30
2.6.1 Laser Radiation......................................................................................................30
2.6.2 Mirrored Reflection ...............................................................................................31
2.6.3 Ablation Products..................................................................................................31
2.6.4 Working Gas ..........................................................................................................32
2.6.5 Topic Ozone...........................................................................................................32
2.7 Electrical Safety - Connection of Devices to External Plugs ...................33
2.8 In Case of Emergency .................................................................................35
2.9 Device Labelling..........................................................................................36
2.9.1 Identification Label of the Device .........................................................................36
2.9.2 Connection Terminal Label of the Device ............................................................37
2.9.3 Mains Input Label of the Device ...........................................................................40
2.9.4 Laser Warning Labels............................................................................................40
3 INTRODUCTION ..............................................................................................42
3.1 Intended Use ...............................................................................................42
3.2 Disclaimer SCHWIND AMARIS Excimer Laser (initial model).................42
3.3 Contraindications and Side Effects ...........................................................43
3.3.1 Absolute Contraindications for Refractive Photo Ablation .................................43
3.3.2 Relative Contraindications....................................................................................43
3.3.3 Direct Side Effects (caused by the laser surgery) ................................................44
3.3.4 Indirect Side Effects (caused by the complete surgery)......................................45
3.3.5 Residual Risks........................................................................................................45
3.3.6 Biocompatibility of Touchable Parts ....................................................................46
4 DEVICE / SYSTEM DESCRIPTION..................................................................47
4.1 General Notes .............................................................................................47
4.2 The Product .................................................................................................47
4.3 System Overview........................................................................................47

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4.4 System Description ....................................................................................49
4.5 Laser Classification.....................................................................................51
4.5.1 Excimer Laser ........................................................................................................52
4.5.2 Aiming Laser and Cross Laser..............................................................................52
4.5.3 OCP Laser ..............................................................................................................52
4.6 Laser Description ........................................................................................53
4.6.1 The Main Principle of the Excimer Laser .............................................................53
4.6.2 Positioning Slit Lights ...........................................................................................53
4.6.3 Fixation LED...........................................................................................................53
4.6.4 Aiming Laser .........................................................................................................53
4.7 Gas Supply ..................................................................................................54
4.8 The Optical System ....................................................................................55
4.9 Microscope and Illumination .....................................................................56
4.9.1 Major Components ...............................................................................................56
4.9.2 Magnification Changer 5 Step ..............................................................................56
4.9.3 Microscope Binocular Tube..................................................................................57
4.10 Particle Aspiration System ........................................................................57
4.10.1 Description.............................................................................................................57
4.10.2 Replacing the Partical Aspiration Nozzles............................................................58
4.10.3 Package Labelling of the Partical Aspiration Nozzle............................................58
4.11 Plume Evacuation System .........................................................................59
4.11.1 Description.............................................................................................................59
Plume Evacuation System - INTERNAL version................................................................ 59
Plume Evacuation System - EXTERNAL version............................................................... 60
4.11.2 Replacing the Plume Evacuation Nozzle..............................................................61
4.11.3 Package Labelling of the Plume Evacuation Nozzle ............................................61
4.11.4 Labelling - Plume Evacuator .................................................................................61
4.12 Patient Bed ..................................................................................................62
4.13 Foot Switch .................................................................................................63
4.14 Optional Features .......................................................................................63
4.14.1 Video System ........................................................................................................63
4.14.2 Printer ....................................................................................................................64
4.14.3 Slit Lamp of the Excimer Laser.............................................................................64

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4.14.4 Online Coherence Pachymetry (OCP) ..................................................................66
4.14.5 6D-/7D-Eye Tracking..............................................................................................66
4.14.6 Cross Laser Module ..............................................................................................66
4.14.7 CXL-365 Vario (cross linking)................................................................................68
4.14.8 Uninterruptable Power Supply (UPS) ..................................................................69
4.14.9 Plume Evacuation System - External ...................................................................70
4.14.10 Video Extender HDMI............................................................................................70
4.15 Approved System Combinations and Optional Accessories / Features 71
5 INSTALLATION................................................................................................73
5.1 General Installation Notes .........................................................................73
5.2 Room and Installation Requirements .......................................................74
5.2.1 General Requirements ..........................................................................................74
5.2.2 Device and Room Dimensions .............................................................................75
5.2.3 Arrangement of the AMARIS Laser Feet..............................................................83
5.2.4 Environmental Conditions ....................................................................................84
5.2.5 Installation Requirements.....................................................................................85
5.3 System Software Requirements ...............................................................86
5.3.1 SCHWIND CAM Software .....................................................................................86
5.4 Shipping ......................................................................................................87
5.4.1 Scope of Delivery ..................................................................................................87
5.4.2 Packing of the Shipping Units ..............................................................................87
5.4.3 Transport Configuration SCHWIND AMARIS / AMARIS 750S / AMARIS 1050RS
88
5.4.4 Transport Configuration SCHWIND AMARIS 500E .............................................89
5.4.5 Unpacking and Checking the Delivery .................................................................90
5.4.6 Transportation Damages ......................................................................................90
5.5 Initial Installation / Start-Up......................................................................91
5.6 Relocation of the Excimer Laser System ..................................................91
6 DEVICE CONTROL AND OPERATION ............................................................92
6.1 General Operation Notes ...........................................................................92
6.2 Control System ...........................................................................................93
6.2.1 Keyboard with Card Reader, Touch Pad and Re-sterilisable Pen .......................94
6.2.2 USB Connectors ....................................................................................................95

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6.3 Emergency Stop Switch.............................................................................95
6.4 Switch ON the Device ................................................................................96
6.4.1 Main Switch...........................................................................................................96
6.4.2 Key Switch.............................................................................................................96
6.4.3 Switch OFF the Device ..........................................................................................97
6.4.4 Disconnection from the Electronic Circuit ...........................................................98
6.5 UPS - Mains Failure or Power Breakdown ...............................................98
6.6 Control Panel of the Excimer Laser ...........................................................99
6.7 Matrix Display ...........................................................................................100
6.8 Operating of the Microscope ...................................................................101
6.9 Microscope Crosshair ...............................................................................102
6.10 Positioning Slits........................................................................................103
6.12 Software Managed Operation of the Excimer Laser .............................104
6.12.1 User Login ...........................................................................................................104
6.12.2 Password Input....................................................................................................104
6.12.3 Main Menu...........................................................................................................105
6.12.4 Movement of the Swivel Laser Arm – AMARIS / AMARIS 750S / AMARIS 1050RS
106
6.12.5 Troubleshooting..................................................................................................107
7 SERVICE PROCEDURES AND FUNCTIONS.................................................108
7.1 Functions Menu ........................................................................................108
7.2 Registration / User Accounts...................................................................109
7.3 Settings Menu...........................................................................................111
7.4 Credit System............................................................................................113
7.5 Treatment Assistant Manager.................................................................118
7.5.1 Editing the List of Surgical Steps .......................................................................119
7.6 Software Update.......................................................................................120
7.7 Fluence Measurement ..............................................................................121
7.7.1 General ................................................................................................................121
7.7.2 Connection of the Fluence Detector ...................................................................121
7.7.3 Performing a Fluence Test..................................................................................122
7.7.4 Automatic Pre-set Energy Adjustment...............................................................127

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7.7.5 Troubleshooting – Fluence Test .........................................................................128
7.8 Drift Test....................................................................................................129
7.9 Gas Exchange - Excimer Laser.................................................................131
7.9.1 Performing of a Gas Change ..............................................................................131
7.10 Export of Log File and Treatment Data...................................................134
7.10.1 Export to External Data Analysis Software........................................................135
7.11 Printout and Video (Export of Treatment PDF and Video)....................136
7.12 Treatment Printout...................................................................................139
8 TREATMENT SELECTION .............................................................................140
8.1 General ......................................................................................................140
8.2 Planning SCHWIND CAM Treatments.....................................................141
8.2.1 Planning of new Treatments...............................................................................141
8.2.2 Import of SCHWIND CAM Treatments...............................................................141
8.3 Performing SCHWIND CAM Treatments ................................................146
8.4 Recovery Function ....................................................................................149
8.5 Eye Tracking..............................................................................................150
8.5.1 Eye Tracking Coordinates Orientation ...............................................................154
8.5.2 Eye Tracking Quality ...........................................................................................155
8.5.3 Static Cyclotorsion Control.................................................................................157
8.5.4 Dynamic Cyclotorsion Correction.......................................................................162
8.5.5 6D Eye Tracking...................................................................................................163
8.5.6 7D Eye Tracking (Latency Free Tracking) ...........................................................165
8.6 Online Coherence Pachymetry (OCP)......................................................166
8.7 Timer..........................................................................................................168
9 CLEANING AND MAINTENANCE.................................................................170
9.1 General Notes ...........................................................................................170
9.2 Cleaning of Non-Sterile Parts ..................................................................172
9.2.1 Cleaning of Excimer Laser Housing ...................................................................173
9.2.2 Cleaning of the Patient Bed ................................................................................173
9.2.3 Cleaning of Touch Screen and Keyboard with Touch Pad, Control Panel, Control
Elements ..............................................................................................................174
9.2.4 Cleaning of the Operating Microscope ..............................................................175

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9.2.5 Cleaning of the Fluence Detector .......................................................................175
9.2.6 Cleaning of the Laser Beam Aperture Area .......................................................176
9.2.7 Cleaning of the Nozzles of Particle Aspiration and Plume Evacuation systems
177
9.3 Reprocessing of Re-sterilisable Parts, Components ..............................177
10 MAINTENANCE .............................................................................................178
10.1 General Notes ...........................................................................................178
10.2 Troubleshooting and Remedies of Operating Microscope ...................179
10.3 Maintenance of the Particle Aspiration System.....................................179
10.4 Maintenance of the Plume Evacuation System .....................................182
10.5 Changing of the ArF Premix Gas Bottle or Helium Gas Bottle .............183
10.6 Technical Security Check (TSC)...............................................................183
10.7 Components and Consumables...............................................................184
10.8 Product Life Expectancy and Expected Service Life ..............................185
10.9 Disposal .....................................................................................................186
11 TECHNICAL DATA .........................................................................................187
12 APPENDIXES .................................................................................................190
12.1 Backup Batteries.......................................................................................190
12.2 Nomogram ................................................................................................190
12.2.1 Customized Ablations .........................................................................................192
12.2.2 Surface and Stromal Treatments .......................................................................192
12.3 Electrical Safety Parts Inside the SCHWIND AMARIS ...........................193
12.4 EMC Guidance and Manufacturer’s Declaration ....................................194
12.4.1 Electromagnetic Interference..............................................................................194
12.4.2 Essential Performance ........................................................................................199
12.4.3 List of Replaceable Cables and Components.....................................................200
13 MANUFACTURER / TECHNICAL ASSISTANCE / APPLICATION SUPPORT
........................................................................................................................201

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List of Figures
Figure 2-1: Accessible beam area (example AMARIS 750S) ........................................................... 31
Figure 2-2: Samples of printer connection ........................................................................................ 33
Figure 2-3: Identification labels AMARIS 750S / 1050RS ................................................................. 36
Figure 2-4: Identification label AMARIS 500E ................................................................................... 36
Figure 2-6: Position of ”Connection Terminal” label AMARIS 750S/1050RS ................................ 38
Figure 2-7: Label “Connection Terminal AMARIS 500E”................................................................. 38
Figure 2-8: Mains input label AMARIS............................................................................................... 40
Figure 2-9: Laser data labels............................................................................................................... 41
Figure 4-1: View of AMARIS 750S / AMARIS 1050RS / AMARIS excimer laser with patient bed 48
Figure 4-2: View of AMARIS 500E excimer laser with patient bed ................................................. 49
Figure 4-3: LED illumination ............................................................................................................... 56
Figure 4-4: Components of the operation microscope (example AMARIS 750S) ......................... 57
Figure 4-5: Particle Aspiration System .............................................................................................. 57
Figure 4-6: Type lable for packaging of partical aspiration nozzles, colour blue, 6 pcs................ 58
Figure 4-7 Single-channel nozzle for the plume evacuation system .............................................. 60
Figure 4-8: External Evacuation unit with filter and tubing mounted to the nozzle ...................... 60
Figure 4-9: Type label for packaging of plume evacuation nozzle - internal version .................... 61
Figure 4-10: Type label for optional plume evacuation system - external version ....................... 61
Figure 4-11: Excimer laser slit lamp................................................................................................... 64
Figure 4-12: Apertures for the slit lamp (sample)............................................................................. 65
Figure 4-13: Exchange of aperture modules ..................................................................................... 65
Figure 4-14: Cross laser projected on patient’s head ....................................................................... 67
Figure 4-15: Cross laser ON/OFF button ............................................................................................ 67
Figure 4-16: CXL-365 vario.................................................................................................................. 68
Figure 4-17: SCHWIND CXL-365 vario in treatment position .......................................................... 69
Figure 4-18: Overview AMARIS Video Extender connection........................................................... 70
Figure 4-19: HDMI female connector at the main supply connector plate..................................... 70
Figure 5-1: AMARIS / AMARIS 750S/ AMARIS 1050RS with swivelling patient bed - front view 75
Figure 5-2: AMARIS / AMARIS 750S/AMARIS 1050RS with swivelling patient bed - side view .. 75
Figure 5-3: AMARIS / AMARIS 750S / AMARIS 1050RS with swivelling patient bed– standard
position.................................................................................................................................. 76
Figure 5-4: AMARIS / AMARIS 750S / AMARIS 1050RS with swivelling patient bed - 30° position
............................................................................................................................................... 77
Figure 5-5: AMARIS / AMARIS 750S / AMARIS 1050RS with swivelling patient bed – 90° position
............................................................................................................................................... 78
Figure 5-6: AMARIS 500E – front view............................................................................................... 79
Figure 5-7: AMARIS 500E – side view ................................................................................................ 79
Figure 5-8: AMARIS 500E with swivelling patient bed – standard position ................................... 80
Figure 5-9: AMARIS 500E with swivelling patient bed - 30° position ............................................. 81
Figure 5-10: AMARIS 500E with swivelling patient bed 90° position ............................................ 82
Figure 5-11: Arrangement of AMARIS / AMARIS 750S / AMARIS 1050RS feet ............................. 83
Figure 5-12: Arrangement of AMARIS 500E feet .............................................................................. 83
Figure 5-13: Truck dimensions ........................................................................................................... 87