Table Of Contents - Abbott Ultiri 1015082 Operation Manual

Contents
Symbols Glossary ......................................................................................................................................................................................................1
Labeling ......................................................................................................................................................................................................................4
Ultiri™ Measurement System ...................................................................................................................................................................................5
Safety Information ......................................................................................................................................................................................................6
Patient and Operator Safety ......................................................................................................................................................................................................... 6
Avoiding Electrical Hazards........................................................................................................................................................................................................... 7
Wireless Communication ............................................................................................................................................................................................................... 9
Electromagnetic Interference ...................................................................................................................................................................................................... 11
Summary of Safety and Clinical Performance ........................................................................................................................................................................... 11
Indications for Use .................................................................................................................................................................................................. 12
Contraindications .................................................................................................................................................................................................... 12
Clinical Benefits ...................................................................................................................................................................................................... 12
Potential Adverse Events ....................................................................................................................................................................................... 13
Reporting Adverse Events ...................................................................................................................................................................................... 13
Warnings, Precautions, and Limitations ................................................................................................................................................................ 14
Warnings ....................................................................................................................................................................................................................................... 14
Precautions................................................................................................................................................................................................................................... 16
Limitations ..................................................................................................................................................................................................................................... 17
System Overview .................................................................................................................................................................................................... 18
System Components .................................................................................................................................................................................................................... 19
Wi-Box AO Transmitter ................................................................................................................................................................................................................ 19
Tableside Controller (TSC) ......................................................................................................................................................................................................... 20
Setting Up the System ........................................................................................................................................................................................... 21
Attaching and Removing the TSC (Table Rail).......................................................................................................................................................................... 21
Mounting ....................................................................................................................................................................................................................................... 22
Making Connections .................................................................................................................................................................................................................... 23
Powering On ................................................................................................................................................................................................................................. 24
Shutting Down .............................................................................................................................................................................................................................. 24
Unmounting .................................................................................................................................................................................................................................. 24
Cleaning and Maintenance .................................................................................................................................................................................... 25
Cleaning ........................................................................................................................................................................................................................................ 25
Maintenance ................................................................................................................................................................................................................................. 26
Infection Control ........................................................................................................................................................................................................................... 26
Troubleshooting............................................................................................................................................................................................................................ 27
System Disposal........................................................................................................................................................................................................................... 27
Specifications .......................................................................................................................................................................................................... 28
Safety and Regulatory ................................................................................................................................................................................................................. 28
Electromagnetic Compatibility (EMC)......................................................................................................................................................................................... 29
Environmental Standards ............................................................................................................................................................................................................ 29
Electrical and Physical ................................................................................................................................................................................................................ 30
Radio ............................................................................................................................................................................................................................................. 31
Electromagnetic Emissions ......................................................................................................................................................................................................... 31
Electromagnetic Immunity ........................................................................................................................................................................................................... 32
Recommended Separation Distances ........................................................................................................................................................................................ 34
Interfaces ...................................................................................................................................................................................................................................... 35
FCC Statement............................................................................................................................................................................................................................. 37
Essential Performance................................................................................................................................................................................................................. 37