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

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Figure 5-14: Transport configuration of AMARIS / AMARIS 750S / AMARIS 1050RS................... 88
Figure 5-15: Transport configuration of AMARIS 500E.................................................................... 89
Figure 6-1: AMARIS / AMARIS 750S/ AMARIS 1050RS with key switch and emergency stop .... 93
Figure 6-2: AMARIS 500E with key switch and emergency stop .................................................... 94
Figure 6-3: Keyboard with touch pad, two re-sterilisable pens and card reader........................... 94
Figure 6-4: Panel PC ONYX – USB ..................................................................................................... 95
Figure 6-5: Label for laser stop........................................................................................................... 95
Figure 6-6: Main switch ....................................................................................................................... 96
Figure 6-7: Key switch ......................................................................................................................... 96
Figure 6-8: Key switch positions ........................................................................................................ 97
Figure 6-9: Control panel of the excimer laser.................................................................................. 99
Figure 6-10: Components of the operation microscope (example AMARIS 750S) ..................... 101
Figure 6-11: Microscope crosshair ................................................................................................... 102
Figure 6-12: Height adjustment of the excimer laser ..................................................................... 103
Figure 6-13: User Login menu .......................................................................................................... 104
Figure 6-14: Main menu .................................................................................................................... 105
Figure 6-15: Swivel laser arm window ............................................................................................ 106
Figure 7-1: Functions menu .............................................................................................................. 108
Figure 7-2: User Account Management (Admin User)................................................................... 109
Figure 7-3: Creation of new users .................................................................................................... 110
Figure 7-4: User Account Management (standard user)............................................................... 110
Figure 7-5: Settings menu of the AMARIS Application Software ................................................. 111
Figure 7-6: Credit code overview ..................................................................................................... 113
Figure 7-7: Import of a new credit file.............................................................................................. 114
Figure 7-8: Credit code overview ..................................................................................................... 115
Figure 7-9: Credit system settings in the Settings Menu ............................................................... 116
Figure 7-10: Message because of decreasing time of credit activation........................................ 117
Figure 7-11: Message because of decreasing number of available credits ................................. 117
Figure 7-12: Treatment Assistant Manager ..................................................................................... 118
Figure 7-13: Edit step dialog ............................................................................................................. 119
Figure 7-14: Software update ........................................................................................................... 120
Figure 7-15: Connection of the fluence detector at AMARIS / AMARIS 750S/1050RS and AMARIS
500E ..................................................................................................................................... 121
Figure 7-16: Holder for the fluence detector ................................................................................... 122
Figure 7-17: Fluence detector with HS-foil – holder ....................................................................... 122
Figure 7-18 : Fluence detector cleaning message .......................................................................... 124
Figure 7-19: Start Screen of the fluence test ................................................................................... 125
Figure 7-20: Fluence test successfully completed .......................................................................... 126
Figure 7-21: Fluence result message/borderline pre-set energy................................................... 127
Figure 7-22: Start of the Drift Test Measurement ........................................................................... 129
Figure 7-23: Confirmation message ‘Drift Test’ .............................................................................. 130
Figure 7-24: Start of a gas change ................................................................................................... 132
Figure 7-25: Gas change in progress ............................................................................................... 132
Figure 7-26: Gas change successful................................................................................................. 133
Figure 7-27: No gas exchange needed ............................................................................................ 133

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Figure 7-28: Export log files.............................................................................................................. 134
Figure 7-29: Export to external data analysis software.................................................................. 135
Figure 7-30: Printout and video ........................................................................................................ 136
Figure 7-31: Selecting a specific day for printout ........................................................................... 137
Figure 7-32: Printing all treatment PDF from a specific day .......................................................... 137
Figure 7-33: Treatment video............................................................................................................ 138
Figure 7-34: Treatment printout ORK page 1 and 2........................................................................ 139
Figure 8-1: Main menu AMARIS....................................................................................................... 140
Figure 8-2: Project file loading settings SCHWIND CAM ............................................................... 142
Figure 8-3: Selection of SCHWIND CAM import file (folder) ......................................................... 143
Figure 8-4: Summary page ............................................................................................................... 144
Figure 8-5: Question to start with which eye first........................................................................... 145
Figure 8-6: AMARIS treatment screen ............................................................................................. 146
Figure 8-7: Surgery comment........................................................................................................... 148
Figure 8-8: Recovery menu ............................................................................................................... 150
Figure 8-9: Arrangement of the coordinate system for the eye tracker ....................................... 151
Figure 8-10: Pupil is not in hot zone................................................................................................. 152
Figure 8-11: Message “Pupil not found”......................................................................................... 153
Figure 8-12: Eye tracking orientation ............................................................................................... 154
Figure 8-13: Infrared LEDs for eye tracking system........................................................................ 155
Figure 8-14: Good eye tracking contrast.......................................................................................... 156
Figure 8-15: Poor eye tracking contrast ........................................................................................... 157
Figure 8-16: Static Cyclotorsional Correction.................................................................................. 158
Figure 8-17: Result – Static Cyclotorsional Correction ................................................................... 159
Figure 8-18: SCC result bigger 5° ..................................................................................................... 160
Figure 8-19: Result – Static Cyclotorsional Correction ................................................................... 161
Figure 8-20: Result – Dynamic Cyclotorsional Correction.............................................................. 163
Figure 8-21: Z-Tracking slider ........................................................................................................... 164
Figure 8-22: Treatment screen with 6D Tracking (exemplary illustration) ................................... 164
Figure 8-23: Online Coherence Pachymeter.................................................................................... 166
Figure 8-24: Online OCP setting in the Settings menu................................................................... 167
Figure 8-25: Timer function............................................................................................................... 169
Figure 9-1: Parts, components and units of AMARIS to be manually cleaned ............................ 172
Figure 9-2: 6D tracking projector (exemplary illustration) ............................................................. 176
Figure 10-1: Replacing a double-channel nozzle ............................................................................ 179
Figure 10-2: Reminder for exchange of nozzle for particle aspiration system............................. 180
Figure 10-3: Entering the serial number of the new particle aspiration filter .............................. 181
Figure 10-4: Changing the nozzle ..................................................................................................... 181
Figure 10-5: Replacing a single-channel nozzle .............................................................................. 182

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List of Tables
Table 1: MAXIMAL LOAD AT POWER OUTLET X1 .......................................................................... 34
Table 2: ELECTROMAGNETIC EMISSIONS ..................................................................................... 195
Table 3: ELECTROMAGNETIC IMMUNITY (1) ................................................................................. 196
Table 4: ELECTROMAGNETIC IMMUNITY (2) ................................................................................. 197
Table 5: ESSENTIAL PERFORMANCE ACCORDING TO IEC 60601-1-2 (2014) clause 5.2.1.1 b). 199
Table 6: REPLACEABLE CABLES AND COMPONENTS.................................................................. 200

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1 GENERAL INFORMATION
1.1 System Identification Data
Product name: SCHWIND AMARIS 1050RS
SCHWIND AMARIS 750S
SCHWIND AMARIS 500E
SCHWIND AMARIS
Device description: Ophthalmologic laser equipment for corneal tissue ablation,
refractive surgery (refer to chapter 3.1 Intended Use).
Medical device class: IIb
Laser classification: 4
Software version: 6.1
Serial number: Refer to identification label of the device(s).
CE labelling: 0483
Approved device combination: Refer to chapter 4.15
System requirements: Refer to chapter 5.2
Manufacturer: SCHWIND eye-tech-solutions GmbH
Mainparkstrasse 6-10
63801 Kleinostheim, GERMANY
Delivery: SCHWIND eye-tech-solutions GmbH
or authorized distributor
Current document status: Version 6.1.6 dated 2020-01-31 EN

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1.2 Symbols for Warnings, Precautionary Measures and Notes
The following conventions are used in this manual:
WARNING!
This symbol advises the user of serious danger for the patient and the user.
CAUTION
The symbol informs the user that particular care is required for safe and
efficient operation of the system.
IMPORTANT NOTE
This symbol provides the user with useful or additional information.
1.3 Notes on the User Manual
The purpose of the user manual is to familiarize the operator(s) of the SCHWIND AMARIS lasers
with the design, operating principle, transport, installation, set-up, safe operation, safety notes
and the care and maintenance of the medical laser device.
IMPORTANT NOTE
The AMARIS User Manual contains the relevant information for the excimer laser
device and the application software only!
Read this User Manual carefully and consider all instructions, as well as safety
and warning notes before starting operation of the SCHWIND AMARIS.
However the AMARIS User Manual does not contain all information necessary
for the safe and effective operation of the SCHWIND AMARIS as a system
combination with the patient bed, the necessary software(s) and/or optional
features!
Therefore consider the accompanying documents:
oUser Manual SCHWIND Patient Bed
oUser Manuals SCHWIND CAM and modules: ORK-CAM and Comparison,
PresbyMAX, PTK-CAM
oReprocessing Instruction for re-sterilisable SCHWIND Products
oInstruction for Use “Getting Started” SCHWIND CXL-365 vario and
manufacturers User Manual (option)
Please keep the User Manual(s) and all related documents close to the medical
device. Allow any user access to the User Manual(s) at all times, store it readily
available.

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IMPORTANT NOTE
An electronic copy of this user manual can be found embedded in the software.
Choose <Help> within AMARIS Application software for User Manual access.
IMPORTANT NOTE
If you have any questions regarding any matters, contact an authorized local
SCHWIND representative or SCHWIND eye-tech-solutions directly for advice.
Refer to chapter 13 Manufacturer / Technical Assistance / Application Support.
IMPORTANT NOTE
The present English manual contains the ORIGINAL INSTRUCTIONS, which are
legally binding. Translations of these must bear the words “Translation of the
Original Instructions”.
1.4 Scope of Documentation
The scope of documentation of the SCHWIND AMARIS includes the “Product Accompanying
Documentation “SCHWIND MEDICAL PRODUCTS”; art.no. 202160x-01 (EN), 202160x-02 (DE),
consisting of:
Medical Apparatus Book “SCHWIND MEDICAL PRODUCTS”
CD-ROM/DVD with “SCHWIND Product Documentation” No. 16316xx, current version,
including the AMARIS User Manual and the relevant manuals as listed in chapter 1.3.
1.5 Declaration of Manufacturer
The SCHWIND AMARIS excimer lasers have been developed according to the applicable
requirements of the European Medical Device Directive 93/42/EEC, as amended (and hence also
according to its German equivalent Medical Device Law MPG 1). The manufacturer SCHWIND
eye-tech-solutions GmbH has been authorized by the notified body “mdc” (listed at the European
Commission with number 0483) to develop, produce and inspect medical devices for
ophthalmologic purposes and to market and service them.
Conformity of the device with the Directive and MPG is ensured only under the following
preconditions:
Delivery is accomplished by SCHWIND eye-tech-solutions or a distributor authorized by
SCHWIND eye-tech-solutions.
All service and maintenance work is performed only by personnel who are authorized by
SCHWIND eye-tech-solutions.
Accessories, consumables and disposables are only authorized and approved by SCHWIND
or an authorized independent testing authority confirm a completely safe operation and
interaction
_1) MPG – Medizin-Produkte-Gesetz is the German Medical Device Regulation

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IMPORTANT NOTE
The Declarations of Conformity for SCHWIND AMARIS excimer laser can be found
on the CD-ROM/DVD No. 163160x SCHWIND Product Documentation.
1.6 Liability of the Manufacturer
SCHWIND eye-tech-solutions does not assume any liability for:
Injuries to persons, unless caused by gross negligence of the manufacturer.
Damages of properties.
Damages / destruction of equipment or software.
Data loss.
Financial, legal, commercial and productivity-related disadvantages for the
company and the personal user.
Or for the following courses of action:
Lack of reading this manual completely and carefully before starting operations with
the SCHWIND AMARIS.
Using the AMARIS Application software on computers not officially approved by
SCHWIND eye-tech-solutions.
Lack of understanding the instructions provided in the user documentation, and the
explanations provided by SCHWIND’s application specialists (otherwise contact
SCHWIND’s application specialists for further details).
Lack of observation of any other instructions and safety requirements provided by
the user information of compatible devices and accessories for ensuring
compatibility and safe operation of the combination between devices.
Use of any compatible device or accessory without having received adequate
inspections and calibrations for proper use and measurement.
Insufficient training of the user, which can give rise to human errors when using the
device with the consequent risk of injury to the patient.
Use of the equipment by not suitably trained personnel.
Use of this device for purposes different than its intended use or for its use outside
the environment of an ophthalmic surgery.
Any attempt to alter, modify or manipulate the product in a way not stipulated in the
User Manual of SCHWIND eye-tech-solutions.
Use of the AMARIS Application software or any of its components in different
applications.
Manipulation, alterations or damages to the software or to the device by technicians
not authorized by SCHWIND eye-tech-solutions or other third parties.
Non-observance of the operating notes, warning symbols and safety instructions in
this manual.
Operational error of user.
Computer virus.
Excessive force.

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Power failure, voltage fluctuations, electromagnetic interference.
Inappropriate storage of the data medium (e.g. humidity or temperature influences)
Erroneous deletion of data by the user.
Negligence by the user.
1.7 Warranty
IMPORTANT NOTE
The duration of the warranty period for the SCHWIND AMARIS excimer laser
system is 12 months.
1. The warranty period begins with the first start-up of the device after signing of the delivery
note by the client.
2. Warranty includes all defects of the device caused by defective parts or manufacturing
faults. Malfunctions that are not caused by improper use are repaired under warranty.
Damage caused by abuse or improper use is not repaired under warranty.
3. The legal warranty applies only to parts that are replaced or repaired by SCHWIND eye-
tech-solutions.
4. Damages or malfunctions have to be reported to SCHWIND eye-tech-solutions or to the
representative immediately.
5. The damaged parts have to be sent back to SCHWIND eye-tech-solutions. When returning
defective parts, please use the original packing or coordinate alternate packing with
SCHWIND eye-tech-solutions.
6. Deficiencies that arise from:
Non-standard or extraordinary use.
Repairs without original parts.
Incorrect treatment of the device.
Inspections, services, device modifications or any form of manipulation of the system
performed by unauthorized personnel will void the guarantee and will relieve
SCHWIND eye-tech-solutions from any responsibility.
7. SCHWIND grants no other warranty, either express or implied, concerning the above-
mentioned parts and their documentation. Any implied warranties of merchantability and
fitness for the particular purpose are disclaimed.
8. SCHWIND shall not be liable for incidental, consequential, indirect, or special damages of
any kind, loss of information or data, or other financial loss arising from or in connection
with the sale or use of the product, whether based in contract, tort (including negligence)
or any other theory.
9. The above-mentioned exclusion of liability is void if the cause of damage is based on intent
or gross negligence. Furthermore, it does not apply to damage due to lack of warranted
quality and claims under product liability.
10. Product improvement initiatives based on technological development are not grounds for
free-of-charge system upgrades.

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11. The General Conditions for Sale, Delivery and Payment of SCHWIND eye-tech-solutions are
generally to be considered.
Consider also General Warranty Regulations of SCHWIND eye-tech-solutions GmbH.
1.8 License Agreement
The license agreements realized between the licensee and SCHWIND eye-tech-solutions GmbH
are binding.
1.9 Copyright
Copyright © 2007-2020 SCHWIND eye-tech-solutions GmbH, Kleinostheim
All rights reserved.
1.10 Trademarks
All names of other companies and their products mentioned in this manual could be trademarks
or registered trademarks.
Quoting of product names is for information only and does not represent any trade mark misuse.
SCHWIND eye-tech-solutions is not liable for the performance or the use of these products.

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2 SAFETY
2.1 General Safety Notes
The instructions given in this chapter are to be considered for proper and safe operation of the
SCHWIND AMARIS.
The medical device was designed and manufactured in compliance with applicable legal
standards and further technical specifications. It is a state-of-the-art product and offers a high
level of safety.
This level of safety can only be maintained in practical use of the system when all required
measures are taken. It is the obligation of every system user to plan and supervise the
performance of these measures.
You will find relevant information in chapter 2.4 Manufacturer’s Responsibility and in chapter 2.5
Operator’s Responsibility.
IMPORTANT NOTE
Observe all safety regulations, notes and precautions in this User Manual to
ensure that the device is operated only in accordance with generally accepted
rules of technology and the relevant regulations for medical devices (refer to
chapter 2.2 Regulations for Medical Devices.
Observe any other instructions and requirements provided by the user
documentation of the different medical devices (especially concerning the
operation of the patient bed) to ensure compatibility and safe operation of the
combination between devices.
For safety recommendations regarding electromagnetic compatibility (EMC)
and restrictions on the use of radio frequency (RF) equipment such as cellular
phones, refer to chapter 12.4. EMC Guidance and Manufacturer’s Declaration.
This is meant for the safety of the patients, for your own safety and for the
protection of the product from damage.
2.2 Regulations for Medical Devices
IMPORTANT NOTE
For safe use of the SCHWIND medical device the operator must consider the
applicable, normative regulations and directives.
The most important of these are:
1. Council Directives concerning Medical Devices MDD 93/42/EEC, as amended
(Regulation valid for EEC countries; please consider the valid national regulations)
2. European Directive 2012/19/EEC (waste electrical and electronic equipment – WEEE)
(Regulation valid for EEC countries; please consider the valid national regulations)