natus Dantec Keypoint G4, Руководство пользователя и сервисное руководство, Страница: 6 / 61

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Table of Contents
Contact Information ................................................................................................................................................ 2
Glossary of Symbols ................................................................................................................................................ 3
Table of Contents .................................................................................................................................................... 6
General Information ............................................................................................................................................... 9
User Guide .......................................................................................................................................................... 9
Intended Use ...................................................................................................................................................... 9
System Overview ................................................................................................................................................ 9
Clinical Performance ........................................................................................................................................... 9
Clinical Benefits .................................................................................................................................................. 9
Medical Conditions ............................................................................................................................................. 9
Intended Users ................................................................................................................................................... 9
Patient Population and Target Group ............................................................................................................... 10
Residual Risks and Side Effects ......................................................................................................................... 10
General and Network Security Measures ......................................................................................................... 10
General Security Policies .............................................................................................................................. 10
Networked Environments ............................................................................................................................ 10
Windows Systems Secure Access ................................................................................................................. 10
Data Confidentiality ..................................................................................................................................... 10
Data Protection ............................................................................................................................................ 10
Protective and Equipment Classification .......................................................................................................... 10
Accuracy of Controls ......................................................................................................................................... 10
Ancillary Accessories ......................................................................................................................................... 11
Safety, Warnings and Precautions ........................................................................................................................ 12
Contraindications ............................................................................................................................................. 12
Warnings........................................................................................................................................................... 12
Cautions ............................................................................................................................................................ 13
Safety Requirements ........................................................................................................................................ 14
Classification ..................................................................................................................................................... 14
Excerpt from the IEC 60601-1 Standard ........................................................................................................... 15
Source Voltage .................................................................................................................................................. 15
Stimulation Electrodes: Maximum Current Density ......................................................................................... 15
Stimulation Pulse Terminology ......................................................................................................................... 16
Accuracy of Controls ......................................................................................................................................... 16
System Hardware .................................................................................................................................................... 17
Workstation ...................................................................................................................................................... 17
Cable Connection Overview ............................................................................................................................. 18
Cable Connections ............................................................................................................................................ 18
Connection Panel .............................................................................................................................................. 19
Isolation Transformer ....................................................................................................................................... 19