Opsens OptoMonitor 3 Instrucciones De Uso página 2

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INTRODUCTION ..................................................................................................................................... 8

Indications for Use ............................................................................................................................ 9

Intended user ........................................................................................................................ 9

Intended environment .......................................................................................................... 9

Contraindications .............................................................................................................................. 9

Safety ................................................................................................................................................ 9

Warnings ............................................................................................................................... 9

Cautions .............................................................................................................................. 10

Precautions ......................................................................................................................... 11

Notes ................................................................................................................................... 11

Storage and Handling ...................................................................................................................... 12

Symbols ........................................................................................................................................... 13

Cybersecurity .................................................................................................................................. 14

COMPLIANCE WITH REGULATORY REQUIREMENTS ........................................................................... 16

Compliance with Standards and Directives .................................................................................... 16

RF Compliance ................................................................................................................................. 20

United States ....................................................................................................................... 20

Canada ................................................................................................................................ 20

Japan ................................................................................................................................... 21

Essential performance .................................................................................................................... 21

Deviation from the standards ......................................................................................................... 21

OVERVIEW OF THE OPTOMONITOR 3 SYSTEM ................................................................................... 22

OptoMonitor 3 Optical Unit (OpM3-OU) ........................................................................................ 23

Cathlab Interface Cables ................................................................................................................. 24

AUX In (AUX Interface Cable) .............................................................................................. 24

Aortic In (AO Transducer Interface Cable) .......................................................................... 24

Aortic Out (Pressure Output Interface Cable) ..................................................................... 24

Distal Out (Pressure Output Interface Cable) ..................................................................... 24

OptoMonitor 3 Display Unit (OpM3-DU) ........................................................................................ 24

Overview of the DU ............................................................................................................. 25

OptoMonitor 3 Handle Unit (OpM3-HU) ........................................................................................ 26

Accessories ...................................................................................................................................... 26

OptoWire Pressure Guidewire (not supplied) .................................................................... 26

Aortic transducer (supplied by others) ............................................................................... 27

Audio and LED Indicators ................................................................................................................ 27

Audio Indicators .................................................................................................................. 27

Color Indicators ................................................................................................................... 28

Graphical User Interface ................................................................................................................. 30

Main Menu Screen Functions ......................................................................................................... 32

LBL-2008-41-v5 OptoMonitor 3 IFU_es Rev 2021-08

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