Wi-Box™ Cath Lab Installation and FAQ December 2011

Wi-Box Ordering Specifics Wi-Box C12783 Wi-Box Power Supply Kit C12785 Cables: Adapter cable (x1) 126XX Monitor cable (x1) 129XX Xpress to Wi-Box cable C12784 Refer to CVD product catalogue for a complete listing of recording systems and adapter/monitor cables (126XX and 129XX series are the same as for current RadiAnalyzer™ Xpress) Top Recording Systems Adapter cables Monitor cables Siemens Sensis 10 pin 12601 12901 Siemens Sensis 7 pin 12649 12901+12849 GE Mac-Lab™ 12618 12918 Philips Xper or Witt series 4/5 12648 12948 Philips Xper Flex Cardio 12616 12916 Philips (Schwarzer) 12660 12960 McKesson/Merge/Picasso Cables V1 12651 12951 McKesson/Merge/Picasso Cables V2 12664 12964 2

Installation General The Wi-Box is permanently installed underneath the cath lab table on a vertical, flat surface with the connectors facing down to avoid fluid contamination and bending of cable connectors Make sure to clean the underlying mounting surface with alcohol before attaching the Wi-Box Make sure the connecting cables are not strained when the cath lab table is moved – test moving the table to its extreme positions after installation Install one Wi-Box in each room where ILUMIEN™ PCI Optimization System, RadiAnalyzer Xpress or any other compatible St. Jude Medical FFR/OCT system may be used to measure FFR Connecting cables (adapter and monitor cables) are ordered according to the specific hemodynamic recording system in each room

Make sure to clean the surface with alcohol before attaching 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 Attach Wi-Box by pushing it firmly toward the surface with the connectors facing down Make sure to clean the surface with alcohol before attaching Wi-Box

Installation 2. Connect to AO transducer and hemodynamic recording system Connect the AO transducer cable to the Adapter cable (Art No: 126XX) Connect the adapter cable to the AO IN connector on the Wi-Box Use the Monitor cable (Art No: 129XX) to connect AO OUT to a free pressure channel on the hemodynamic recording system AO pressure may be zeroed per standard cath lab procedure on the hemodynamic recording system Adapter cable AO transducer cable AO transducer Recording System

Installation 3. Perform function control Verify that the AO transducer is connected to AO IN Verify that AO OUT is connected to a pressure channel on the recording system Zero the pressure channel on the hemodynamic recording system Check if the green “READY” light on the Wi-Box is lit YES: Wi-Box is powered by the hemodynamic recording system and is ready for use NO: The red “NOT READY” light is lit The power from the hemodynamic recording system is too low, Wi-Box requires a power supply to function (sold separately) NO: Neither the READY nor NOT READY lights are lit There is an error with either the Wi-Box or with the cables, replace Wi-Box and cables

Order Number for Wi-Box PSU Kit: C12785 Installation 4. If required, connect the Wi-Box power supply Note: If the Wi-Box requires a power supply, it is not possible to use Wi-Box with RadiAnalyzer Xpress Connect the power supply instrument plug to the “XPRESS/PSU” socket on the Wi-Box Connect the power supply to mains Verify that the white and green indicators are lit If the red “NOT READY” light is still lit, an internal error has occurred and the unit must be replaced Order Number for Wi-Box PSU Kit: C12785

Link Wi-Box with ILUMIEN System (Before first FFR procedure)

Link Wi-Box with ILUMIEN The Wi-Boxes in each room are the source of AO pressure AO pressure and PressureWire™ Aeris™ enable ILUMIEN to measure pressures 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. Important Notice regarding linking Wi-Box with ILUMIEN The Wi-Boxes in each room are the source of AO pressure PressureWire Aeris enables ILUMIEN to measure and calculate FFR Before starting to use the ILUMIEN console, each Wi-Box in all rooms must be linked to a unique room setup profile on the ILUMIEN console. Every Wi-Box has a serial number (S/N) of 8 digits. This is the Wi-Box’s ”identity Number.” The first time you install a Wi-Box, you connect the serial number to a room (cath lab) and can then name that room (1, 2, 3... or blue, green, etc.). By selecting which room the console is placed in at the beginning of an FFR procedure, the ILUMIEN console can then automatically connect to the correct Wi-Box and AO source for that room. It is important to make sure that the correct Wi-Box is linked to the correct room setup profile on the ILUMIEN console. If a Wi-Box is moved to another room, the room profile on the ILUMIEN console must be updated with the new room.

Link Wi-Box with ILUMIEN 1. Check Wi-Box and Turn on ILUMIEN Verify “Ready” light on Wi-Box Turn on ILUMIEN system 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. STEP 1- Check Wi-Box and Turn on ILUMIEN Wheel in the ILUMIEN console to the cath lab room with Wi-Box. Make sure that the Wi-Box is connected to the hemodynamic recording system and that the recording system is powered – indicated by the Ready Light on the Wi-Box. Plug in and turn on the ILUMIEN console. Main switch next to power cable

Link Wi-Box with ILUMIEN 2. Create Test Patient STEP 2- Create Test Patient Select “Add new patient” Enter a Test Patient ID, First and Last name – any ID and Name is OK Click on “New FFR Recording” Note: If a test patient already exists in the system, this can be chosen as well.

Link Wi-Box with ILUMIEN 3. Link Wi-Box with a room profile on ILUMIEN Verify that the Wi-Box on screen has an identical serial number as the Wi-Box physically installed in the current room Identify room by name and number STEP 3- Link Wi-Box with a room profile on ILUMIEN On the screen, all Wi-Boxes within radio range of ILUMIEN should now appear as buttons with the name “Unknown” and a unique serial number Verify that the Wi-Box on screen has an identical serial number as the Wi-Box physically installed in the current room Click on the Wi-Box button on screen and identify room by name and number, then click OK The Wi-Box button should now change name to the room name and number you entered

Link Wi-Box with ILUMIEN 4. Repeat 1-3 for all rooms and Wi-Boxes Use the previously entered test patient when setting up all rooms Delete the test patient when done ILUMIEN

Starting an FFR Case with Wi-Box™ Solution and RadiAnalyzer™ Xpress

FFR Procedure with Wi-Box and RadiAnalyzer Xpress Roll in RadiAnalyzer Xpress and connect to Wi-Box Roll in and turn on RadiAnalyzer Xpress Connect the RadiAnalyzer Xpress Wi-Box cable between AO IN on RadiAnalyzer and XPRESS/PSU on Wi-Box Note: To enable PressureWire reading on the recording system, a cable may be connected between PW OUT on RadiAnalyzer Xpress to the recording system. It is recommended to omit this cable for mobile RadiAnalyzer Xpress usage in order to simplify FFR workflow. Adapter cable Recording System AO transducer cable RadiAnalyzer Xpress AO IN AO transducer

FFR Procedure with Wi-Box and RadiAnalyzer Xpress Zero AO on RadiAnalyzer Xpress Select CAL AO(Pa) and press ENTER Open AO transducer to air and press ENTER Note: If the Auto Setup sequence is activated, the first step (Zero cathlab) must be skipped by pressing ENTER on the remote control

FFR Procedure with Wi-Box and RadiAnalyzer Xpress Cal PressureWire Select CAL WIRE(Pd) and press ENTER Flush the PressureWire packaging coil, place flat and press ENTER Note: If the Auto Setup sequence is activated, the first step (Zero cathlab) must be skipped by pressing ENTER on the remote control

FFR Procedure with Wi-Box and RadiAnalyzer Xpress Equalize and record FFR (Same procedure as without Wi-Box) Advance PressureWire until its pressure sensor is placed at the opening of the guide catheter Flush catheter from contrast and make sure to close all valves, remove wire introducer Equalize AO and PressureWire pressures using the Equalize function on the RadiAnalyzer Xpress Advance PressureWire to region of interest Induce hyperemia per standard cath lab protocol Press Rec to record pressure, press stop to review recording and FFR Refer to instructions of use for RadiAnalyzer Xpress for full FFR or CFR procedure instructions.

Using Wi-Box and RadiAnalyzer Xpress with the Auto Setup Sequence Press ENTER to skip first step and continue Open AO transducer to air and press ENTER Flush the PressureWire packaging coil, place flat and press ENTER Note: If PW OUT on the RadiAnalyzer Xpress is connected to the cath lab recording system, the first step is necessary to balance RadiAnalyzer Xpress PW OUT with PW IN on hemodynamic recording system

Miscellaneous Re-Zero AO pressure transducer If the AO pressure transducer needs to be re-zeroed during the case, both the AO IN on RadiAnalyzer Xpress and the AO pressure channel on the hemodynamic recording system need to be zeroed: Open AO transducer to air Zero AO on RadiAnalyzer Xpress Zero AO on hemodynamic recording system Note: The order of steps 2 and 3 is not important.

Wi-Box FAQ For use with ILUMIEN and RadiAnalyzer Xpress

Wi-Box FAQ Q: Since the Wi-Box is permanently placed between the AO transducer and the hemodynamic recording system, is there a risk for erroneous readings, inaccuracy or time delay? Answer: The Wi-Box is an electrical circuit “listening” to the pressure from the connected AO transducer and transmitting the pressure via radio to a receiver. Electrically, the AO transducer is still directly hardwired to the hemodynamic recording system through the Wi-Box. The Wi-Box does not change the accuracy of the pressure read by the hemodynamic recording system. There is no time delay through the Wi-Box; if one pressure is passing through the Wi-Box and one is directly connected to the recording system, there is no difference in time delay between the two pressure readings.   22

Wi-Box FAQ Q: Since the Wi-Box is permanently placed between the AO transducer and the hemodynamic recording system, is there a risk for AO failure during normal cath lab operation – not involving ILUMIEN or RadiAnalyzer Xpress? Answer: The Wi-Box is designed with a direct, hardwired connection between the AO transducer and the hemodynamic recording system. Even in the unlikely event that the software or electronics in the device would fail, the AO pressure is still passed straight through the device to the recording system. Pressure is still passed through the Wi-Box, even without power supply. If for any reason the user wishes to disconnect the Wi-Box, simply unplug the AO transducer cable from the adapter cable and plug it straight into the hemodynamic recording system, bypassing the Wi-Box. 23

Wi-Box FAQ Q: With the Wi-Box between the AO transducer and the hemodynamic recording system, how does the lab zero the AO pressure during a case that does not involve FFR? Answer: The AO pressure is zeroed exactly as it is without the Wi-Box – by opening the AO transducer valve to air and zeroing the corresponding pressure channel on the hemodynamic recording system 24

FAQ Wi-Box Q: On some recording systems, an arbitrary pressure value can be seen on-screen when the AO transducer is disconnected from the Wi-Box – why? Answer: Some hemodynamic recording systems automatically detect when an AO transducer is disconnected. This enables the system to stop displaying pressure when the AO transducer is disconnected after a case, between patients. With the Wi-Box always connected to the pressure port, the hemodynamic recording system may not detect when the AO transducer is disconnected and will keep displaying pressure coming in from the Wi-Box. Without an AO transducer connected, the pressure reading from the open-ended connector will be an arbitrary, random, pressure value. This phenomenon does not affect the pressure reading when there is an AO transducer (with a patient) connected; the problem is limited to possible confusion when seeing an arbitrary pressure value on the screen between cases. If, for any reason, the user wishes to disconnect the Wi-Box, they can simply unplug the AO transducer cable from the adapter cable and plug it straight into the hemodynamic recording system, bypassing the Wi-Box.   25

Wi-Box FAQ Q: Can the Wi-Box transmit AO pressure to ILUMIEN at the same time it is connected to a RadiAnalyzer Xpress? Answer: Yes, Wi-Box is capable of simultaneously providing AO pressure to ILUMIEN and RadiAnalyzer Xpress if they are used in the same room at the same time. However, if a power supply unit is required to operate the Wi-Box, it is not possible to also connect to a RadiAnalyzer Xpress, since the power supply unit uses the same port. 26

Wi-Box FAQ Q: Why is a power supply sometimes required and sometimes not? Answer: The Wi-Box is designed to work using only the excitation voltage provided by the invasive pressure port on the hemodynamic recording system, without the need for an additional power supply. Some combinations of recording systems and AO transducers may limit the available power to the Wi-Box; if this occurs the NOT READY light on the Wi-Box will light up after the AO transducer is connected. In this case, an additional Power Supply unit is required to power the Wi-Box. Electrical power requirements Power Input: 2.4 to 8 VDC For 2.4 to 4 VDC, use Wi-Box External Power Supply Electrical requirements AO transducer: Input impedance >270 Ohm For complete technical specifications, refer to the Wi-Box IFU. 27

Wi-Box FAQ Q: What troubleshooting steps should be performed if the AO pressure is not identical on the ILUMIEN/RadiAnalyzer Xpress and the hemodynamic recording system? Answer: Open the AO transducer to air Zero AO pressure on ILUMIEN or RadiAnalyzer Xpress Zero pressure on hemodynamic recording system Close AO transducer to air to resume pressure reading 28

Wi-Box FAQ Q: How does the Wi-Box connect with ACIST or similar contrast injectors with a built in AO transducer? Answer: The Wi-Box always connects between the AO transducer and the cath lab recording system If there is a ACIST device, Wi-Box connects between its AO transducer and the hemodynamic recording system ACIST with AO transducer Hemodynamic Recording system Wi-Box Adapter Cable Monitor Cable 29

Secure Radio Technology PressureWire Aeris and Wi-Box utilize advanced radio technology to ensure a stable and secure communication with ILUMIEN/Xpress and to avoid disturbing other systems. Transmitters (Aeris and Wi-Box) and Receivers (inside ILUMIEN) lock to each other using unique identification codes stored in the transmitters The Receiver stores the last connected transmitter in its memory In the event of power failure, the Receivers resume communication automatically The system utilizes “Frequency-Hopping Spread Spectrum” technology (FHSS) and changes transmitting frequency randomly at 400 times/s The technology minimizes the risk of interference with, or disturbance from, other systems in the cath lab Very low radio power further reduces risk of interfering with other systems PressureWire USB Receiver PressureWire Aeris Transmitter 400 hops/s 79 channels AO USB Receiver Wi-Box Transmitter 30

Radio Technology FAQ Q: Can the radio signal be disturbed by mobile phones, Wi-Fi networks, X-ray, etc? Answer: No. PressureWire Aeris and Wi-Box utilize an advanced radio technology called "frequency hopping" where the information is sent several times using multiple radio frequencies. The system changes radio frequency 400 times per second, which means that even if there are several interfering radio sources, the signal will reach the receiver on other frequencies Extensive, real-life cath lab testing has been performed without interruption of radio communication 31

Radio Technology FAQ Q: Can PressureWire Aeris or Wi-Box cause disturbances to other cath lab systems? Answer: PressureWire Aeris and Wi-Box are designed to interfere as little as possible with other radio devices The transmitted radio power is very low - max 1 mW (0.001) and average 70 μW (0.000070), which is 1000 to 10.000 times lower than the power from a normal cellular phone The frequency-hopping technique further reduces the risk by transmitting on each frequency for only a very short time The lead enclosure in cath labs reduces the amount of radio power emitted from inside the cath lab. PressureWire Aeris and Wi-Box have passed all radio acceptance tests by US FCC and EU R&TTE. 32

Radio Technology FAQ Q: Can several pairs of PressureWire Aeris/Wi-Box and ILUMIEN/Receivers be used at the same time in the same environment? Answer: Yes. At the start of a procedure, PressureWire Aeris and Wi-Box lock to ILUMIEN using a built-in unique identifier code ILUMIEN can only receive pressure from one connected PressureWire Aeris and one Wi-Box regardless of any other devices used in the same environment The frequency-hopping scheme is random, which means that several pairs of PressureWire Aeris, Wi-Boxes and ILUMIEN systems can communicate in the same environment without disturbing each other 33

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. PressureWire Aeris, Wi-Box and RadiAnalyzer are designed, developed and manufactured by St. Jude Medical Systems AB. ILUMIEN, PressureWire, Aeris, RadiAnalyzer, Wi-Box, LightLab, 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. Mac-Lab is a registered or unregistered trademark or service mark of GE Healthcare. ©2011 St. Jude Medical, Inc. All rights reserved IPN 1830-11