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ILUMIEN™ PCI Optimization System How to Use in FFR and OCT Procedures ILUMIEN™ – System Overview FFR and OCT C7 DragonflyTM OCT Catheter ILUMIEN™ Console OCT Wireless FFR PressureWireTM AerisTM Cath lab Recording System Wi-Box™ AO Transducer Adapter Cable 2 Monitor Cable ILUMIEN™ – Console Overview Physician’s Side Operator’s Side Physician’s Monitor Operator’s Monitor DOC Keyboard Hibernate/ wake-up button Removable Tray Connector Panel Mouse CD/DVD Drive Service Access Panel Chart Holder Fan Filter Main Power Switch Wheel Locks 3 Main Power Cord Connector System Components Component Item No ILUMIEN™ Console 900-700-00 Wi-Box™ C12783 (One for each room) Adapter and Monitor Cables 4 126XX and 129XX (Item number depends on hemodynamic system) Quick Setup Solution for ILUMIEN™ and RadiAnalyzer™ ILUMIEN™ FFR + OCT RadiAnalyzerTM Xpress RadiAnalyzerTM Cathlab Recording System Wi-Box™ AO Transducer Adapter Cable 5 Monitor Cable ILUMIEN™ PCI Optimization System Installation of the ILUMIEN™ PCI Optimization System ILUMIEN™ Installation Installation Overview 1. Install Wi-Box™ in all cath lab rooms where ILUMIEN™ or other St. Jude Medical FFR equipment will be used 2. Link ILUMIEN™ to each Wi-Box™ individually IMPORTANT To simplify identification of each Wi-Box™, it is advisable to power off all Wi-Boxes by disconnecting them from the cath lab recording system until they are being linked with ILUMIEN™. 7 Wi-Box™ Installation 1. Mount Wi-Box™ on cath lab table floor column Remove the protective cover on the adhesive surface on the back of Wi-Box™ 8 Attach Wi-Box™ by pushing it firmly toward the surface with the connectors facing down Wi-Box™ Installation 2. Connect with AO transducer and hemodynamic recording system Adapter cable AO transducer 9 Recording System AO transducer cable ILUMIEN PCI Optimization System Link Wi-Box™ Wireless Solution with ILUMIEN™ System (Before First FFR Procedure) Link Wi-Box™ with ILUMIEN™ The Wi-Box in each room is the source of AO pressure PressureWire Aeris enables ILUMIEN to measure and calculate FFR Each Wi-Box in all rooms must be linked to a unique room setup profile on the ILUMIEN console It is important to make sure that the correct Wi-Box is linked to the correct room If a Wi-Box is moved to another room, the room profile on the ILUMIEN console must be updated with the new room IMPORTANT To simplify identification of each Wi-Box™, it is advisable to power off all Wi-Boxes by disconnecting them from the cath lab recording system until they are being linked with ILUMIEN™. 11 Link Wi-Box™ with ILUMIEN™ 1. Check Wi-Box™ and turn ON ILUMIEN™ Wait for “Ready” light on Wi-Box™ Hibernate/Wake-up button on upper right of keyboard NOTE: If the system is in hibernate mode, the power indicator light on the monitors will be amber. Main switch next to power cable 12 Link Wi-Box™ with ILUMIEN™ 2. Create Test Patient 13 Link Wi-Box™ with ILUMIEN™ 3. Link Wi-Box™ with a room profile on ILUMIEN™ a) Verify that Wi-Box™ on screen has an identical serial number as Wi-Box™ physically installed in the current room b) Identify room by name and number 14 Link Wi-Box™ with ILUMIEN™ 4. Repeat 1-3 for all rooms a) Use the previously entered test patient when setting up all rooms b) Delete the test patient when done 15 ILUMIEN™ PCI Optimization System Starting a Case Turning ON the System – Power Switches Hibernate/Wake-up button on upper right of keyboard NOTE: If the system is in hibernate mode, the power indicator light on the monitors will be amber. Main Switch next to power cable 17 Starting Up 18 Select Patient or Add New Patient 19 Import from Database 20 Add New Patient 21 Rx Only Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. ILUMIEN, PressureWire, RadiAnalyzer, Dragonfly, C7-XR, GOLDEN IMAGE, the color Gold, LIGHTLAB, Wi-Box, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2011 St. Jude Medical, Inc. All rights reserved IPN 1681-11 22