State: Released Date: 2019.03.06 22:30 GMT QUANTIEN™ Measurement System Diagnostic Computer C12787 Instructions for Use State: Released Date: 2019.03.06 22:30 GMT CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies. Pat. http://patents.sjm.com © 2019 St. Jude Medical, LLC. All Rights Reserved. State: Released Date: 2019.03.06 22:30 GMT Contents QUANTIEN™ Measurement System .......................................................................... 1 Introduction to the Instructions for Use (IFU) ............................................................. 1 Highlights Used ................................................................................................................. 1 Product Description ................................................................................................... 2 Introduction ...................................................................................................................... 2 Intended Use .................................................................................................................... 3 Indications for Use ............................................................................................................ 3 Contraindications ............................................................................................................... 3 Users ................................................................................................................................ 3 Product Interface and Symbols .......................................................................................... 3 Symbols Used on Product, Packaging, and IFU .................................................................. 5 Remote Control Symbols and Functions .............................................................................. 7 Additional Devices and Accessories .................................................................................... 7 General Warnings, Precautions, and Safety Information ....................................................... 8 Graphical User Interface .................................................................................................. 10 Indicator Lights and Sounds ............................................................................................. 12 Basic Setup Using Wi-Box™ AO Transmitter (Wireless AO Source) ........................... 12 Install Wi-Box™ AO Transmitter ....................................................................................... 13 Unpack QUANTIEN™ Measurement System .................................................................... 13 Mount QUANTIEN™ Main Unit in the Cath Lab ................................................................ 14 Room Configuration ......................................................................................................... 16 Measure FFR or RFR .............................................................................................. 17 Warnings and Precautions ............................................................................................... 17 Live Window .................................................................................................................... 18 FFR/RFR Measurement Procedure ................................................................................... 19 Review Recordings .................................................................................................. 25 Review Window ............................................................................................................... 25 Study Summary ............................................................................................................... 26 Review Recording ............................................................................................................ 26 Export Data ..................................................................................................................... 28 Review Archived Studies ......................................................................................... 30 Archive Window............................................................................................................... 30 Export and Delete Files in Archive .................................................................................... 31 Settings ................................................................................................................... 32 System Settings Overview ................................................................................................. 32 Room Setup .................................................................................................................... 32 Regional Settings ............................................................................................................. 35 User Settings ................................................................................................................... 35 Security Settings .............................................................................................................. 36 Connections .................................................................................................................... 37 Network Configuration ..................................................................................................... 41 Display Settings ............................................................................................................... 44 Service ............................................................................................................................ 46 Demo Mode .................................................................................................................... 46 Troubleshooting ...................................................................................................... 47 On Screen Messages ....................................................................................................... 47 i State: Released Date: 2019.03.06 22:30 GMT Tracing EM Interference ...................................................................................................53 Troubleshooting Tables .................................................................................................... 55 Maintenance ........................................................................................................... 67 Remote Control Battery .................................................................................................... 67 System Backup Battery .................................................................................................... 68 Disposal ..........................................................................................................................68 Cleaning ..........................................................................................................................68 Preventative Maintenance Schedule .................................................................................68 Leakage Current Measurement .........................................................................................69 Testing PW IN .................................................................................................................70 Testing PW OUT and Associated Monitor Channel ............................................................. 71 Testing AUX IN 1 and Associated Monitor Channel ............................................................ 72 Testing AUX IN 2 and Associated Monitor Channel ............................................................ 73 Testing AUX OUT 1 & 2 and Associated Monitor Channel .................................................. 73 Test Probes .....................................................................................................................74 Leakage Adapters ............................................................................................................75 Service or Repair .............................................................................................................75 Technical Specifications .......................................................................................... 75 Pressure Measurement .................................................................................................... 75 Electrical Specifications .................................................................................................... 75 Specifications Interfaces...................................................................................................75 Dimensions .....................................................................................................................77 Environmental Conditions ................................................................................................. 77 Isolation Diagram .............................................................................................................78 File Formats ....................................................................................................................79 Compliance with Regulatory Requirements .............................................................