SCHWIND Amaris 500E - Page 4

USER MANUAL (Instruction for Use) SW 6.1
General Information
Version 6.1.6 dated 2020-01-31 EN Page 4 of 201
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