USER MANUAL (Instruction for Use) SW 2.9
General Information
Version 2.9.7 dated 2020-12-23 Page 4 of 75
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2.9 In Case of Emergency ........................................................................................................ 19
2.10 Labelling .............................................................................................................................. 20
2.10.1 Labelling Pendular Device .............................................................................................. 20
2.10.2 Labelling Disposable Blades - Packaging Option A ..................................................... 20
2.10.3 Labelling Disposable Blades – Packaging Option B ..................................................... 22
2.10.4 Type Label of the Disposable Tubings .......................................................................... 24
2.11 Explanation of Graphic Symbols used in the Labels ...................................................... 27
3 INTRODUCTION ............................................................................................... 30
3.1 Intended Use ...................................................................................................................... 30
3.2 Side-Effects ......................................................................................................................... 30
3.3 Contraindications for LASIK.............................................................................................. 31
4 DEVICE / SYSTEM DESCRIPTION .................................................................. 32
4.1 System Overview ............................................................................................................... 32
4.2 Principle of Cutting ............................................................................................................ 32
4.3 Product Features and Components ................................................................................. 33
4.3.1 Cutting Head .................................................................................................................... 33
4.3.2 Disposable Blades ........................................................................................................... 34
4.3.3 Suction Ring .................................................................................................................... 35
4.3.4 Drive Motor ...................................................................................................................... 36
4.3.5 Pendulum Axis ................................................................................................................ 36
4.3.6 Tonometer ....................................................................................................................... 36
4.3.7 Console – Control Unit .................................................................................................... 36
4.3.8 Foot Pedal ........................................................................................................................ 38
4.3.9 Monitoring Software ....................................................................................................... 39
4.3.10 List of Applied Parts ........................................................................................................ 39
4.4 Intended Accessory ............................................................................................................ 39
4.4.1 Disposable Tubing .......................................................................................................... 39
4.4.2 Lid Speculum ................................................................................................................... 40
4.5 Approved System Combinations ..................................................................................... 41
5 INSTALLATION ................................................................................................ 42
5.1 General Notes ..................................................................................................................... 42
5.2 System Requirements ....................................................................................................... 43
5.3 Shipping .............................................................................................................................. 43
5.3.1 Scope of Delivery ............................................................................................................ 43
5.3.2 Packing of the Shipping Units ........................................................................................ 43
5.3.3 Unpacking and Checking the Delivery .......................................................................... 44
5.3.4 Transportation Damages ................................................................................................ 45