Abbott OPTIS 1014933 - Table of Contents

Contents
Symbols .............................................................................................................................................................................. 1
OPTIS™ Integrated Next Imaging System .................................................................................................................................. 5
Safety Information ................................................................................................................................................................. 6
Patient Safety ................................................................................................................................................................................... 6
Operator Safety ................................................................................................................................................................................. 8
Avoiding Electrical Hazards.................................................................................................................................................................. 9
Electromagnetic Interference ............................................................................................................................................................. 12
Safety Functions Built Into the OPTIS Integrated Next ............................................................................................................................. 12
Indications for Use ............................................................................................................................................................. 13
Contraindications ............................................................................................................................................................... 13
Complications .................................................................................................................................................................... 14
Warnings and Precautions ................................................................................................................................................... 14
Warnings ........................................................................................................................................................................................ 14
Warnings (OCT) .............................................................................................................................................................................. 14
Precautions (OCT) .......................................................................................................................................................................... 15
Warnings and Precautions (Fractional Flow Reserve [FFR], Resting Full-Cycle Ratio [RFR]) .......................................................................... 16
Connecting to External Equipment / Accessories ................................................................................................................................... 16
Mechanical Enclosure ...................................................................................................................................................................... 17
Electrical ........................................................................................................................................................................................ 17
Electronic Interference ...................................................................................................................................................................... 18
Aortic Reference Pressure ................................................................................................................................................................. 18
Defibrillation .................................................................................................................................................................................... 18
System Security .............................................................................................................................................................................. 18
System Overview ............................................................................................................................................................... 19
System Features.............................................................................................................................................................................. 19
System Components......................................................................................................................................................................... 20
System Setup .................................................................................................................................................................... 25
Positioning the System ...................................................................................................................................................................... 25
Connecting the System ..................................................................................................................................................................... 27
Powering On ................................................................................................................................................................................... 27
Shutting Down ................................................................................................................................................................................. 28
Cleaning and Maintenance .................................................................................................................................................. 29
Cleaning ........................................................................................................................................................................................ 29
Maintenance ................................................................................................................................................................................... 30
Infection Control .............................................................................................................................................................................. 35
User Troubleshooting ....................................................................................................................................................................... 36
System Disposal .............................................................................................................................................................................. 37
System Specifications ......................................................................................................................................................... 38
System - Safety and Regulatory .......................................................................................................................................................... 38
System - Electrical and Physical ......................................................................................................................................................... 39
Imaging Specifications ...................................................................................................................................................................... 40
Physiology Specifications .................................................................................................................................................................. 40
Electromagnetic Emissions ................................................................................................................................................................ 41
Electromagnetic Immunity .................................................................................................................................................................. 41
Recommended Separation Distances .................................................................................................................................................. 43
FCC Statement................................................................................................................................................................................ 44
Essential Performance ...................................................................................................................................................................... 44
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release