USER MANUAL (Instruction for Use) SW 2.9
General Information
Version 2.9.7 dated 2020-12-23 Page 3 of 75
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Table of Contents
Dear Customer ................................................................................................................................. 2
Table of Contents ............................................................................................................................. 3
List of Figures ................................................................................................................................... 6
1 GENERAL INFORMATION .................................................................................7
1.1 System Identification Data.................................................................................................. 7
1.2 Symbols for Warnings, Precautionary Measures and Notes ........................................... 8
1.3 Notes on the User Manual .................................................................................................. 8
1.4 Scope of Documentation ..................................................................................................... 9
1.5 Declaration of Manufacturer according to the European MDD 93/42/EWG for
Microkeratome Carriazo-Pendular ..................................................................................... 9
1.6 Liability of the Manufacturer ............................................................................................ 10
1.7 Warranty ............................................................................................................................. 11
1.7.1 Limited Warranty of Parts and Items ............................................................................. 11
1.7.2 Limitation of Warranty and Liability - General ............................................................. 11
1.7.3 Exclusion of Warranty and Liability ............................................................................... 11
1.7.4 Exclusive Warranties....................................................................................................... 12
1.8 License Agreement ............................................................................................................ 12
1.9 Copyright ............................................................................................................................ 12
1.10 Trademarks ......................................................................................................................... 12
2 SAFETY ............................................................................................................. 13
2.1 General Notes ..................................................................................................................... 13
2.2 Regulations for Medical Devices ...................................................................................... 13
2.3 Restrictions of Use and Safety Precautions .................................................................... 14
2.4 Data and Virus Protection ................................................................................................. 14
2.5 Manufacturer’s Responsibility .......................................................................................... 14
2.5.1 Training of User’s and Operating Personnel ................................................................ 15
2.5.2 Instruction and Training ................................................................................................. 15
2.5.3 Protective Measures of the Manufacturer .................................................................... 16
2.5.4 Conformity with Safety Standards ................................................................................ 16
2.5.4.1 Electrical Safety, Mechanical Safety, Functional Safety ................................. 16
2.5.4.2 Electromagnetic Compatibility (EMC) ............................................................... 16
2.6 Operator’s Responsibility .................................................................................................. 17
2.6.1 Patient and Personal Safety ........................................................................................... 17
2.6.2 Device Safety ................................................................................................................... 18
2.6.3 Electrical Safety ............................................................................................................... 18
2.7 Dangers Resulting from Device Operation ...................................................................... 19
2.8 Protection from Unauthorized Use .................................................................................. 19
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