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SCHWIND Amaris 500E Eye Laser Machine Manuals
Manuals and User Guides for SCHWIND Amaris 500E Eye Laser Machine. We have
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SCHWIND Amaris 500E Eye Laser Machine manual available for free PDF download: User Manual
SCHWIND Amaris 500E User Manual (201 pages)
Excimer Laser
Brand:
SCHWIND
| Category:
Measuring Instruments
| Size: 9 MB
Table of Contents
Dear Customer
2
Table of Contents
3
Content
3
List of Figures
10
List of Tables
13
1 General Information
14
System Identification Data
14
Symbols for Warnings, Precautionary Measures and Notes
15
Notes on the User Manual
15
Scope of Documentation
16
Declaration of Manufacturer
16
Liability of the Manufacturer
17
Warranty
18
License Agreement
19
Copyright
19
Trademarks
19
2 Safety
20
General Safety Notes
20
Regulations for Medical Devices
20
Restrictions of Use and Safety Precautions
21
Manufacturer's Responsibility
22
Training of User and Operating Personnel
22
Protective Measures of the Manufacturer
23
Conformity with Safety Standards
23
Operator's Responsibility
25
Patient Safety
25
Device Safety
26
Electrical Safety
26
Patient Bed Interlock
27
Laser Warning Lamp and Door Interlock
27
Protective Glasses
28
Protective Clothing
28
Data and Virus Protection
29
Data Input
29
Protection from Data Loss
29
Protection from Unauthorized Use
30
Dangers Resulting from Laser Operation
30
Laser Radiation
30
Mirrored Reflection
31
Ablation Products
31
Figure 2-1: Accessible Beam Area (Example AMARIS 750S)
31
Working Gas
32
Topic Ozone
32
Electrical Safety - Connection of Devices to External Plugs
33
Figure 2-2: Samples of Printer Connection
33
Table 1: MAXIMAL LOAD at POWER OUTLET X1
34
In Case of Emergency
35
Device Labelling
36
Identification Label of the Device
36
Figure 2-3: Identification Labels AMARIS 750S / 1050RS
36
Figure 2-4: Identification Label AMARIS 500E
36
Connection Terminal Label of the Device
37
Figure 2-6: Position of "Connection Terminal" Label AMARIS 750S/1050RS
38
Figure 2-7: Label "Connection Terminal AMARIS 500E
38
Mains Input Label of the Device
40
Laser Warning Labels
40
Figure 2-8: Mains Input Label AMARIS
40
Figure 2-9: Laser Data Labels
41
3 Introduction
42
Intended Use
42
Disclaimer SCHWIND AMARIS Excimer Laser (Initial Model)
42
Contraindications and Side Effects
43
Absolute Contraindications for Refractive Photo Ablation
43
Relative Contraindications
43
Direct Side Effects (Caused by the Laser Surgery)
44
Indirect Side Effects (Caused by the Complete Surgery)
45
Residual Risks
45
Biocompatibility of Touchable Parts
46
4 Device / System Description
47
General Notes
47
The Product
47
System Overview
47
Figure 4-1: View of AMARIS 750S / AMARIS 1050RS / AMARIS Excimer Laser with Patient Bed
48
System Description
49
Figure 4-2: View of AMARIS 500E Excimer Laser with Patient Bed
49
Laser Classification
51
Excimer Laser
52
Aiming Laser and Cross Laser
52
OCP Laser
52
Laser Description
53
The Main Principle of the Excimer Laser
53
Positioning Slit Lights
53
Fixation LED
53
Aiming Laser
53
Gas Supply
54
The Optical System
55
Microscope and Illumination
56
Major Components
56
Magnification Changer 5 Step
56
Figure 4-3: LED Illumination
56
Microscope Binocular Tube
57
Particle Aspiration System
57
Description
57
Figure 4-4: Components of the Operation Microscope (Example AMARIS 750S)
57
Figure 4-5: Particle Aspiration System
57
Replacing the Partical Aspiration Nozzles
58
Package Labelling of the Partical Aspiration Nozzle
58
Figure 4-6: Type Lable for Packaging of Partical Aspiration Nozzles, Colour Blue, 6 Pcs
58
Plume Evacuation System
59
Description
59
Plume Evacuation System - INTERNAL Version
59
Plume Evacuation System - EXTERNAL Version
60
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
Replacing the Plume Evacuation Nozzle
61
Package Labelling of the Plume Evacuation Nozzle
61
Labelling - Plume Evacuator
61
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
Patient Bed
62
Foot Switch
63
Optional Features
63
Video System
63
Printer
64
Slit Lamp of the Excimer Laser
64
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
Online Coherence Pachymetry (OCP)
66
7D-Eye Tracking
66
Cross Laser Module
66
Figure 4-14: Cross Laser Projected on Patient's Head
67
Figure 4-15: Cross Laser ON/OFF Button
67
Vario (Cross Linking)
68
Figure 4-16: CXL-365 Vario
68
Uninterruptable Power Supply (UPS)
69
Figure 4-17: SCHWIND CXL-365 Vario in Treatment Position
69
Plume Evacuation System - External
70
Video Extender HDMI
70
Figure 4-18: Overview AMARIS Video Extender Connection
70
Figure 4-19: HDMI Female Connector at the Main Supply Connector Plate
70
Approved System Combinations and Optional Accessories / Features
71
5 Installation
73
General Installation Notes
73
Room and Installation Requirements
74
General Requirements
74
Device and Room Dimensions
75
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
Arrangement of the AMARIS Laser Feet
83
Figure 5-11: Arrangement of AMARIS / AMARIS 750S / AMARIS 1050RS Feet
83
Figure 5-12: Arrangement of AMARIS 500E Feet
83
Environmental Conditions
84
Installation Requirements
85
System Software Requirements
86
SCHWIND CAM Software
86
Shipping
87
Scope of Delivery
87
Packing of the Shipping Units
87
Figure 5-13: Truck Dimensions
87
Transport Configuration SCHWIND AMARIS / AMARIS 750S / AMARIS 1050RS
88
Figure 5-14: Transport Configuration of AMARIS / AMARIS 750S / AMARIS 1050RS
88
Transport Configuration SCHWIND AMARIS 500E
89
Figure 5-15: Transport Configuration of AMARIS 500E
89
Unpacking and Checking the Delivery
90
Transportation Damages
90
Initial Installation / Start-Up
91
Relocation of the Excimer Laser System
91
6 Device Control and Operation
92
General Operation Notes
92
Control System
93
Figure 6-1: AMARIS / AMARIS 750S/ AMARIS 1050RS with Key Switch and Emergency Stop
93
Keyboard with Card Reader, Touch Pad and Re-Sterilisable Pen
94
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
USB Connectors
95
Emergency Stop Switch
95
Figure 6-4: Panel PC ONYX - USB
95
Figure 6-5: Label for Laser Stop
95
Switch on the Device
96
Main Switch
96
Key Switch
96
Figure 6-6: Main Switch
96
Figure 6-7: Key Switch
96
Switch off the Device
97
Figure 6-8: Key Switch Positions
97
Disconnection from the Electronic Circuit
98
UPS - Mains Failure or Power Breakdown
98
Control Panel of the Excimer Laser
99
Figure 6-9: Control Panel of the Excimer Laser
99
Matrix Display
100
Operating of the Microscope
101
Figure 6-10: Components of the Operation Microscope (Example AMARIS 750S)
101
Microscope Crosshair
102
Figure 6-11: Microscope Crosshair
102
Positioning Slits
103
Figure 6-12: Height Adjustment of the Excimer Laser
103
Software Managed Operation of the Excimer Laser
104
User Login
104
Password Input
104
Figure 6-13: User Login Menu
104
Main Menu
105
Figure 6-14: Main Menu
105
Movement of the Swivel Laser Arm - AMARIS / AMARIS 750S / AMARIS 1050RS
106
Figure 6-15: Swivel Laser Arm Window
106
Troubleshooting
107
7 Service Procedures and Functions
108
Functions Menu
108
Figure 7-1: Functions Menu
108
Registration / User Accounts
109
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
Settings Menu
111
Figure 7-5: Settings Menu of the AMARIS Application Software
111
Credit System
113
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
Treatment Assistant Manager
118
Figure 7-12: Treatment Assistant Manager
118
Editing the List of Surgical Steps
119
Figure 7-13: Edit Step Dialog
119
Software Update
120
Figure 7-14: Software Update
120
Fluence Measurement
121
General
121
Connection of the Fluence Detector
121
Figure 7-15: Connection of the Fluence Detector at AMARIS / AMARIS 750S/1050RS and AMARIS 500E
121
Performing a Fluence Test
122
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
Automatic Pre-Set Energy Adjustment
127
Figure 7-21: Fluence Result Message/Borderline Pre-Set Energy
127
Troubleshooting - Fluence Test
128
Drift Test
129
Figure 7-22: Start of the Drift Test Measurement
129
Figure 7-23: Confirmation Message 'Drift Test
130
Gas Exchange - Excimer Laser
131
Performing of a Gas Change
131
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
Export of Log File and Treatment Data
134
Figure 7-28: Export Log Files
134
Export to External Data Analysis Software
135
Figure 7-29: Export to External Data Analysis Software
135
Printout and Video (Export of Treatment PDF and Video)
136
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
Treatment Printout
139
Figure 7-34: Treatment Printout ORK Page 1 and 2
139
8 Treatment Selection
140
General
140
Figure 8-1: Main Menu AMARIS
140
Planning SCHWIND CAM Treatments
141
Planning of New Treatments
141
Import of SCHWIND CAM Treatments
141
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
Performing SCHWIND CAM Treatments
146
Figure 8-6: AMARIS Treatment Screen
146
Figure 8-7: Surgery Comment
148
Recovery Function
149
Eye Tracking
150
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
Eye Tracking Coordinates Orientation
154
Figure 8-12: Eye Tracking Orientation
154
Eye Tracking Quality
155
Figure 8-13: Infrared Leds for Eye Tracking System
155
Figure 8-14: Good Eye Tracking Contrast
156
Static Cyclotorsion Control
157
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
Dynamic Cyclotorsion Correction
162
Eye Tracking
163
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
Eye Tracking (Latency Free Tracking)
165
Online Coherence Pachymetry (OCP)
166
Figure 8-23: Online Coherence Pachymeter
166
Figure 8-24: Online OCP Setting in the Settings Menu
167
Timer
168
Figure 8-25: Timer Function
169
9 Cleaning and Maintenance
170
General Notes
170
Cleaning of Non-Sterile Parts
172
Figure 9-1: Parts, Components and Units of AMARIS to be Manually Cleaned
172
Cleaning of Excimer Laser Housing
173
Cleaning of the Patient Bed
173
Cleaning of Touch Screen and Keyboard with Touch Pad, Control Panel, Control Elements
174
Cleaning of the Operating Microscope
175
Cleaning of the Fluence Detector
175
Cleaning of the Laser Beam Aperture Area
176
Figure 9-2: 6D Tracking Projector (Exemplary Illustration)
176
Cleaning of the Nozzles of Particle Aspiration and Plume Evacuation Systems
177
Reprocessing of Re-Sterilisable Parts, Components
177
10 Maintenance
178
General Notes
178
Troubleshooting and Remedies of Operating Microscope
179
Maintenance of the Particle Aspiration System
179
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
Maintenance of the Plume Evacuation System
182
Figure 10-5: Replacing a Single-Channel Nozzle
182
Changing of the Arf Premix Gas Bottle or Helium Gas Bottle
183
Technical Security Check (TSC)
183
Components and Consumables
184
Product Life Expectancy and Expected Service Life
185
Disposal
186
11 Technical Data
187
12 Appendixes
190
Backup Batteries
190
Nomogram
190
Customized Ablations
192
Surface and Stromal Treatments
192
Electrical Safety Parts Inside the SCHWIND AMARIS
193
EMC Guidance and Manufacturer's Declaration
194
Electromagnetic Interference
194
Table 2: ELECTROMAGNETIC EMISSIONS
195
Table 3: ELECTROMAGNETIC IMMUNITY (1)
196
Table 4: ELECTROMAGNETIC IMMUNITY (2)
197
Essential Performance
199
Table 5: ESSENTIAL PERFORMANCE ACCORDING to IEC 60601-1-2 (2014) Clause 5.2.1.1 B)
199
List of Replaceable Cables and Components
200
Table 6: REPLACEABLE CABLES and COMPONENTS
200
13 Manufacturer / Technical Assistance / Application Support
201
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