Optopol SOCT Copernicus - Table of Contents

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SOCT User Manual Version 10.0 rev. A
1 DESCRIPTION OF THE DEVICE ............................................................................................. 13
INTENDED USE ...................................................................................................................... 13
INTENDED USER .................................................................................................................... 14
THE MINIMUM KNOWLEDGE ............................................................................................ 14
EDUCATION NEEDED FOR OPERATING THE TOMOGRAPH.......................................................... 14
OPERATING SKILLS ......................................................................................................... 14
OCCUPATIONAL SKILLS ..................................................................................................... 15
JOB REQUIREMENTS FOR THE USER .................................................................................... 15
PLACES OF USE ..................................................................................................................... 15
PATIENT POPULATION ............................................................................................................. 15
PROPER INSTRUMENT USE ....................................................................................................... 15
CONTRAINDICATION ............................................................................................................... 16
INSTRUCTION MANUAL AVAILABILITY ................................................................................. 16
INSTRUCTION MANUAL APPLICABILITY ............................................................................... 16
DISPOSAL ..................................................................................................................... 17
PROTECTIVE MEASURES FOR IT SYSTEMS ................................................................................... 17
CYBERSECURITY FUNCTIONS .................................................................................................... 17
SYSTEM OVERVIEW ........................................................................................................ 17
AUTHENTICATION OF USERS ............................................................................................. 18
AUTO-LOGOFF .............................................................................................................. 18
ENSURE TRUSTED CONTENT ............................................................................................. 18
CYBERSECURITY EVENT .................................................................................................... 18
RECOVER ...................................................................................................................... 18
OTHER IMPLEMENTED MECHANISMS .................................................................................. 19
2 TECHNICAL DATA ................................................................................................................ 20
TECHNICAL DATA REVO NX 130 / REVO NX ............................................................................. 20
SOCT COPERNICUS REVO/ SOCT COPERNICUS / REVO 60/REVO 80 ........................................ 21
TECHNICAL DATA REVO FC .................................................................................................... 22
DEVICE CLASSIFICATION .......................................................................................................... 23
MINIMUM COMPUTER SYSTEM REQUIREMENTS ........................................................................... 23
CAPTURE STATION .......................................................................................................... 23
REVIEW STATION ............................................................................................................ 24
3 SAFETY .............................................................................................................................. 25
SAFETY INFORMATION ............................................................................................................ 25
PRODUCT LABEL ................................................................................................................... 26
SAFETY STANDARDS ............................................................................................................... 28
WARNINGS .......................................................................................................................... 30
CAUTIONS ........................................................................................................................... 34
GENERAL NOTES ................................................................................................................... 36
NOTES ON USE ..................................................................................................................... 38