QUANTIEN™ Measurement System Diagnostic Computer

State: Released Date: 2019.03.06 22:30 GMT

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

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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 ...... 79 Compliance with Standards and Directives ...... 79 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ...... 80 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ...... 81 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and QUANTIEN™ System ...... 83 Warranty Disclaimer ...... 84 Australian Warranty ...... 84

State: Released Date: 2019.03.06 22:30 GMT

QUANTIEN™ Measurement System Introduction to the Instructions for Use (IFU) This IFU contains both the instructions for use for the operator and technical information including installation and maintenance instructions. This IFU describes the handling of the QUANTIEN™ measurement system. For operation of the QUANTIEN measurement system, other devices need to be connected. Consult the IFU for each of these devices for details on handling and safety information. NOTE: Pictures are shown for example only. Highlights Used Bold font is used in the IFU to identify the names of buttons, menus, and windows, and is also used for some subheadings. Warnings, cautions and notes are used in the following way: WARNING: The personal safety of the patient or user may be involved. Disregarding this information could result in injury. CAUTION: These instructions point out special service procedures or precautions that you must follow to avoid damaging the device. Note: This provides information you might find especially useful or information that facilitates maintenance or clarifies important instructions. The following abbreviations and terms are used in this IFU:

Table 1. Abbreviations used in this IFU

Abbreviatio Description n AO Aortic Pressure Cath lab Catheterization laboratory CF Cardiac Floating PCI Percutaneous Coronary Intervention FFR Fractional Flow Reserve (Pd/Pa, measured at maximum hyperemia) HRS Hemodynamic recording system (Hemodynamic recording system) IFU Instruction for Use Pa Proximal Pressure Pd Distal Pressure PW PressureWire™ guidewire RFR Resting Full-cycle Ratio Study As used in this IFU a study consists of all FFR measurement recordings for one patient on the same occasion/procedure

State: Released Date: 2019.03.06 22:30 GMT

Product Description Introduction

Figure 1. QUANTIEN™ Main Unit with Table Stand and Remote Control

The QUANTIEN™ measurement system is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), and data from ECG. Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure (Pd) to aortic pressure (Pa), measured during hyperemia. It provides the maximal blood flow in the presence of a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical situation that the stenosis was not present. Pd/Pa at rest is the ratio of distal coronary arterial pressure to aortic pressure measured at resting conditions. Resting Full-cycle Ratio (RFR) is the ratio of Pd to Pa at a point in the cardiac cycle where the Pd/Pa ratio is minimal. RFR is designed to be used at rest and, in contrast to Pd/Pa at rest, is a sub-cycle metric. These physiological parameters are measured when the QUANTIEN™ measurement system is used with the manufacturer’s distal intracoronary pressure transducer and a proximal aortic pressure transducer. The physician may use the FFR, Pd/Pa at rest and RFR parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. Information on screen can also be transferred to an external HRS or to an external video monitor. Recorded procedures can be viewed on a PC for post-procedural review and analysis with application specific viewing software installed, such as RadiView™ software. Additional functions let you import a patient work list from the hospital DICOM1‡ system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

1 DICOM is a registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information.

State: Released Date: 2019.03.06 22:30 GMT

Intended Use The QUANTIEN™ measurement system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices. Indications for Use The QUANTIEN™ measurement system is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. The QUANTIEN measurement system is intended for use in the catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. Contraindications The device has no patient alarm functions. Do not use it for cardiac monitoring. Users Normal operation: The QUANTIEN™ measurement system should be handled by or supervised by a physician with training in catheterization laboratory procedures. Preventative maintenance: Hospital technician Installation: Hospital technician/IT personnel, St. Jude Medical sales representative/technician. Product Interface and Symbols The QUANTIEN™ measurement system includes a main unit with a touch screen user interface and several input/output ports, a remote control, a power cable and an ethernet patch cable with isolator.

State: Released Date: 2019.03.06 22:30 GMT

Figure 2. QUANTIEN™ Interface

Table 2. QUANTIEN™ Interface and Port Symbols

No. Symbol or marking Explanation 1 N/A QUANTIEN™ main unit 2 N/A Display – touch screen 3 N/A Power cable with power supply unit 4 N/A Indicator light, power supply 5 N/A Patch cable and isolation box 6 PressureWire™ IN PressureWire IN on PressureWire interface – Pd signal from PressureWire guidewire (white sleeve). Connection to applied part. 7 AUX IN 1 AO signal from cath lab recording system (yellow sleeve) 8 AUX IN 2 ECG signal from HRS (black sleeve) 9 AUX OUT 1 Pa, Pd or reference signal output (grey sleeve) 10 AUX OUT 2 Pa, Pd or reference signal output (grey sleeve) 11 N/A Heat sink and connection block for mounting bracket (VESA standard 75 x 75 mm and 100 x 100 mm)

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Table 2. QUANTIEN™ Interface and Port Symbols

No. Symbol or marking Explanation 12 PressureWire™ OUT PressureWire OUT on PressureWire interface – Pd signal to external monitor (green sleeve). Connection to applied part. 13 DVI-I output – video display/monitor

14 USB port – Memory stick, data export, software upgrade

15 Ethernet – network connection

16 On/Off switch

17 N/A Remote control 18 N/A Slot for storing remote control Symbols Used on Product, Packaging, and IFU The following symbols may be found on the product or product label: Symbol Description Follow instructions for use. (Symbol appears blue on product labeling.)

Affixed to this device in accordance with European Council Directives 2002/96/EC and 2006/66/EC. These directives call for separate collection and disposal of electrical and electronic equipment. Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. Intertek Safety Agency Certification Mark

Canada 310 This device complies with RSS-310 of Industry Canada. Operation is subject to the condition that this device does not cause harmful interference. Caution

Defibrillation-proof Type CF equipment

Manufacturer

State: Released Date: 2019.03.06 22:30 GMT

The following symbols may be found on the product or product label: Symbol Description Catalog number

Serial number

Lot Number

Consult instructions for use

Follow instructions for use on this website

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Quantity

Date of Manufacture

Keep dry

Temperature limitations

Humidity limitation

European conformity, affixed according to the relevant provisions of MD directives 93/42/EEC and 2011/65/EU, and RE directive 2014/53/EU Annex II. Hereby, St. Jude Medical declares that this device complies with the essential requirements and other relevant provisions of these directives.

The full text of the European Union RE directive 2014/53/EU declaration of conformity is available at the following internet address: www.sjmglobal.com/euconformity. Diagnostic Computer

Medical equipment

Finished good

Authorized Representative in the European Community

State: Released Date: 2019.03.06 22:30 GMT

The following symbols may be found on the product or product label: Symbol Description Do not use if package is damaged

Software version

Software upgrade kit

Instructions for use

Australian Sponsor Remote Control Symbols and Functions The remote control can be used instead of the touch screen to perform FFR/RFR measurements, and for navigation/selections in other windows (limited function). The remote control signal is indicated by a white indicator flash at the top, right corner of the open window.

Figure 3. Remote Control

1. Arrows: Move right/left (up/down), select a specific menu button/value or move the cursor in the Review window. A selected menu button or value is always highlighted. 2. OK/Enter: Confirm the selection of a menu button or function, or confirm entered values. 3. AO: Open the Pa drop-down menu in Live window, allow zero of the AO pressure. 4. PW: Open the Pd drop-down menu in Live window, allow zero of the PressureWire™ guidewire. 5. Live: Main function key, start/stop/recording, go directly to Live window. 6. EQUALIZE: Equalize AO and Pd pressures. 7. MARKER: Add marker during recording. 8. EDIT: Open Annotation dialogue box in the Review window.

Additional Devices and Accessories Devices and accessories that are required or optional for use with the QUANTIEN™ measurement system are listed in the tables below. Only these products are permitted to be used with the QUANTIEN measurement system. All are ordered separately, either from St. Jude Medical or from other manufacturers.

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Table 3. Devices and Accessories Manufactured by St. Jude Medical

Device Comments Mounting bracket Required. Several models available. Wall mount, desktop stand, bedside pole bracket and pole bracket. PressureWire™ guidewire Required. Use the PressureWire™ Aeris™ guidewire or PressureWire™ X wireless guidewire for wireless connection. Use the PressureWire™ Certus™ guidewire or PressureWire™ X cable connection guidewire for connection by cable. Wi-Box™ AO transmitter Required for wireless configuration. Interface for wireless transmission and cables of AO pressure to the QUANTIEN™ measurement system. Adapter and monitor cables are required for connection to HRS. RadiView™ software Optional. Software for installation on a PC. Allows for post-procedural reviewing and analysis of FFR measurements. AUX IN/ECG cables Optional. For transmission of AO pressure and ECG signals to the QUANTIEN measurement system from the HRS, specific cables for each system. PressureWire Out cable Optional. For transmission of distal pressure from the QUANTIEN measurement system to the HRS, cables specific for each system. Service kit Used when testing leakage current and PW IN/OUT on the QUANTIEN measurement system. Also used for testing AO IN/OUT on the Wi-Box AO™ transmitter. AUX Out cable Optional. For export of Pa or Pd analog signal to an external measuring instrument.

Table 4. Devices and Accessories from Other Suppliers

Device Comments Aortic pressure (AO) Required. Transducer shall comply with the standard for invasive transducer blood pressure transducers, ANSI/AAMI BP22-1994. DVI-I cable Optional. Video cable to display QUANTIEN™ screen on a cath lab monitor or external video monitor (e.g., conference room). Ethernet cable Optional. Network cable. QUANTIEN measurement system network connection (RJ45). Mounting bracket If other than St. Jude Medical standard bracket is used, it must comply with VESA standard 75x75 mm or 100x100 mm. USB memory stick Only a port-powered USB memory stick is allowed. General Warnings, Precautions, and Safety Information Warnings . No modification of this equipment is allowed. . Do not open or remove access covers on the QUANTIEN™ measurement system unless specifically instructed by St. Jude Medical technical support to do so. . External equipment intended for connection to signal input, signal output or other

State: Released Date: 2019.03.06 22:30 GMT

connectors, shall comply with relevant IEC standard (e.g., IEC 60601 series for medical electrical equipment). In addition, all such combinations of systems shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. Any person who connects external equipment to signal output, or other connectors, has formed a system and is therefore responsible for compliance of the system with these requirements. If in doubt, contact a qualified technician, or alternatively, a St. Jude Medical representative or technical support. . Do not use the QUANTIEN measurement system if it has been dropped or in any other way exposed to mechanical or electrical damage. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data. Contact St. Jude Medical representative or technical support for further instructions. . Do not use the QUANTIEN measurement system if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with). . High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ guidewire and the QUANTIEN measurement system. . Do not use the QUANTIEN measurement system if liquid is suspected to have penetrated the enclosure or the power supply unit. This can cause the user or patient to be exposed to electric shock. Contact St. Jude Medical representative or technical support for further instructions. . Do not sterilize the QUANTIEN measurement system or any of its parts. Do not use this system or any of its parts if it has been sterilized. . The QUANTIEN measurement system contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced. . Do not leave the QUANTIEN measurement system unattended when logged in as a Site Administrator. . To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access controlled environment. Cautions . The QUANTIEN™ measurement system is Type CF equipment and protected against the effects of a discharge of a defibrillator. PressureWire™ guidewire readings may be affected by defibrillation. After defibrillation restart procedure, i.e. re-zero and re-equalize PressureWire guidewire. . If it is necessary to install the QUANTIEN measurement system adjacent to other equipment, this system should be observed to verify normal operation. If abnormal performance is observed, it is necessary to increase distance between equipment. Notes . The QUANTIEN™ measurement system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the QUANTIEN measurement system. See Guidance and manufacturer’s declaration - electromagnetic immunity (page 81). . Please refer to Tracing EM interference (page 53) for support in identifying possible sources of EM interference.

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. The reception of data from wireless sources (either the PressureWire™ Aeris™ guidewire or PressureWire™ X wireless and the Wi-Box™ AO transmitter) may be disturbed by other equipment even if that equipment complies with CISPR emission requirements. . To avoid environmental damage and/or personal injury, handling and disposal of batteries and electronic equipment shall be done in accordance with applicable local, state and federal laws and regulations. . ECG display is not intended for cardiac diagnostics. Functional Safety During use according to this IFU, the QUANTIEN™ measurement system will maintain following essential performance: . Accuracy of measurements . Accuracy of signal outputs . Integrity of recorded data Graphical User Interface All user interactions are performed directly on the touch screen or by using the remote control (limited options). Surgical gloves or plastic cover protection do not affect the touch screen functionality. The graphical interface is dynamic and will change appearance depending on the selected menu, measurement mode, or current state of the instrument. To change the user interface language, see Regional Settings (page 17). For explanation of symbols, see the table below Buttons and symbols commonly used in the graphical interface. Other symbols are explained when they occur in the IFU.

Table 5. Buttons and Symbols Commonly Used in the Graphical Interface

Symbol Explanation

Setup menu/window

Accept /Select/Indicator for OK (blue checkmark)

Cancel/Indicator for fail (red cross)

Delete (blue symbol)

Refresh form (blue symbol)

Search function (blue symbol)

Scroll buttons. Grey indicates "end of list" and blue that there are more posts.

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Figure 4. Display Menu (Illustrates the Layout of and Common Functions in the Graphical User Interface)

Table 6. Description of Display Menu

1 Information bar Display depends on the current menu (e.g. patient, selected room, time, etc.). 2 Move back to next higher menu 3 Name of the open menu (currently selected) 4 Menu Tree 5 Main Menu bar (Setup) Installation and setup Patient Enter New Patient Live Real-time FFR measurement Review Review recordings on active patient Archive Recording archive 6 Live main function button. Go direct to Live window, Start/Stop recording or other functions depending on active window. NOTE: Some features may not be available for all users. Refer to User Settings for more information. (page 35)

State: Released Date: 2019.03.06 22:30 GMT

Indicator Lights and Sounds

Table 7. Indicator Lights and Sounds

Power status light Placement: On the power supply unit Green light when connected to power Remote control Placement: In the top section of the open window, to the left of the indicator Abbott Medical logo A white indicator flashes when a signal is received from the remote control Start-up indicator A signal (beep) will be heard a few seconds after switching on the unit, indicating that the system is booting up PressureWire™ A signal (beep) will be heard when PressureWire guidewire signal is guidewire connection connected to QUANTIEN™ measurement system indicator Basic Setup Using Wi-Box™ AO Transmitter (Wireless AO Source) An FFR or RFR procedure requires a proximal pressure (Pa) signal from an AO transducer and a distal pressure (Pd) signal from a PressureWire™ guidewire. This chapter describes the basic configuration of the QUANTIEN™ measurement system where a wireless AO source (Wi-Box™ AO transmitter) and either a wireless PressureWire™ guidewire or cable connected PressureWire™ guidewire are used. See figure below.

Figure 5. QUANTIEN™ Measurement System Basic Setup

State: Released Date: 2019.03.06 22:30 GMT

Table 8. Required Components for Basic Setup

1 A wireless PressureWire™ guidewire (See Additional Devices and Accessories for more information) 2 A QUANTIEN™ measurement system 3 A cable connected PressureWire guidewire (See Additional Devices and Accessories for more information) 4 An aortic pressure transducer 5 An adapter cable, to connect the AO transducer with the Wi-Box™ AO transmitter. Specific cable for each HRS 6 A Wi-Box™ AO transmitter 7 The HRS Install Wi-Box™ AO Transmitter The basic wireless setup requires installation of the Wi-Box™ AO transmitter (ordered separately from St. Jude Medical). The Wi-Box AO transmitter is permanently mounted underneath the cath lab table, one in each room where the QUANTIEN™ measurement system will be used. The AO pressure transducer signal is connected to the Wi-Box AO transmitter and then passed through unaffected to the HRS. The Wi-Box AO transmitter transmits the AO pressure wirelessly to the QUANTIEN measurement system or other St. Jude Medical™ FFR measurement systems. NOTE: Reference the IFU for the Wi-Box AO transmitter for complete installation instructions and safety information. Unpack QUANTIEN™ Measurement System Unpack the box with the QUANTIEN™ measurement system and check that the following components have been supplied: . One QUANTIEN™ main unit with power supply unit . One remote control . Four mains cables, see table below . One ethernet patch cable with isolator . The QUANTIEN measurement system IFU

Table 9. Identification of Mains Cables

United States Rated Voltage: 125 V Rated Current: 7 A

United Kingdom Rated Voltage: 250 V Rated Current: 2.5 A

Europe (excluding UK) Rated Voltage: 250 V Rated Current: 2.5 A

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Table 9. Identification of Mains Cables

Australia Rated Voltage: 250 V Rated Current: 2.5 A

NOTE: If a cable needs to be replaced the cord set shall fulfill applicable regulations. If in doubt please contact St. Jude Medical. CAUTION: For markets other than those specified in the table above, make sure the chosen cord set fulfills applicable regulations. To be able to mount and install the QUANTIEN main unit, a mounting bracket is required. Use brackets supplied separately from St. Jude Medical or use an existing bracket compatible with standard VESA 75 x 75 mm or 100 x 100 mm. Refer to the Placement Options table for possible mounting solutions. Before proceeding with installation, check that all parts are undamaged. Mount QUANTIEN™ Main Unit in the Cath Lab WARNING: . Make sure the equipment is securely mounted. If the equipment is not securely attached, it may fall over causing possible patient or operator injury and damage to the system. . Do not use the QUANTIEN™ measurement system if it has been dropped or in any other way exposed to mechanical or electrical damage. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data. Contact St. Jude Medical representatives or technical support for further instructions. . Do not use the QUANTIEN measurement system if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with). . To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access controlled environment. CAUTION: Make sure a power cable with a connector suitable for the mains power outlet is used. Verify that the chosen cord set fulfills applicable ratings and regulations. St. Jude Medical recommends the QUANTIEN measurement system is installed in a secure, access controlled environment. If the QUANTIEN measurement system is not permanently mounted, it should be stored in a secured, access controlled location. The design of the QUANTIEN measurement system allows flexible placement either inside or outside the patient environment with fast and easy setup regardless of position. The placement in the cath lab will impact which devices, wireless or wired, can be connected. Benefits and limitations for different placement are summarized in the table below.

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Table 10. Placement Options

Options Benefits Limitations Desktop − No equipment on bed rail − Sterile operator limited to remote − Easy access to network/video control – limited functionality connectors − Limited to wireless PressureWire™ Non-sterile nurse can operate guidewire − Display on cath lab monitor Wall − No equipment on bed rail or − Sterile operator limited to remote table surfaces control – limited functionality − Easy access to network/video − Limited to wireless PressureWire connectors guidewire − Non-sterile nurse can operate − Display on cath lab monitor Bedside − Close to operator − Instrument on bed rail − Sterile operator can control all − Limited access to network/video features connectors − Allow use of both wireless and cable connected PressureWire guidewire − Display on cath lab monitor Mobile − One instrument for multiple − Longer set up time (mounted on rooms – cost effective − Floor interference IV-pole) − Allows use of both wireless − Limited access to network/video and cable connected connectors PressureWire guidewire 1. Attach the mounting bracket to the back of the QUANTIEN main unit following the instructions provided with the bracket.

2. Mount the QUANTIEN main unit in the desired place in the cath lab. Do not tilt the main unit backward more than a maximum of 45º from the vertical line. Do not mount the main unit tilted forward to prevent risk of ingress of liquids, such as IV-infusion etc. WARNING: Do not use QUANTIEN measurement system if it has been exposed to liquids when NOT mounted according to above. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data. Contact St. Jude Medical representative or technical support for further instructions. If a table top stand is used, the table should be horizontal. Ensure that the mounting is secure and that the position of the QUANTIEN main unit is stable. 3. Connect the mains cable from the mains power connector on the power supply unit to a mains power outlet. Connect in such way that the mains cable can be easily removed from the wall power outlet. For identification of correct mains cable, see the table, Identification of mains cables. NOTE: The equipment conforms to specifications when operated in a temperature range of +15°C to +35°C and relative humidity range of 30% to 75% and in an atmospheric pressure range of 525 mmHg to 795 mmHg.

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Powering On and Shutting Down Powering On Check that the mains cable is connected to the power supply unit and to the mains power outlet. Press the power switch on the bottom panel to start the QUANTIEN™ measurement system. The screen will remain dark for a few seconds before a startup beep indicates that the system is booting up. When the status check is OK, indicated by blue checkmarks, the User Login window appears. Enter your credentials to log into the system. See User Settings for more information (page 35). WARNING: Do not leave the QUANTIEN measurement system unattended while logged in as a Site Administrator. NOTE: If you do not have credentials to log into the system, you can log in as "guest". After login, the Select Room window appears. If a room configuration is set as default then the first screen will be the Patient menu. Select Skip to move to the (Setup) menu where any menu can be selected. At interruption of supply mains for less than 5 minutes an ongoing examination can be continued seamlessly provided that both Pa and Pd have been zeroed before power was lost. After power recovery you will be asked if the previous examination shall be continued. If you select to continue, the examination will continue. Otherwise the system will perform a normal start up. If supply mains is interrupted for more than 5 minutes, the QUANTIEN measurement system will always perform a normal start up. Shutting Down Press the switch on the bottom panel to OFF to shut down. CAUTION: The power switch will shut down the QUANTIEN™ measurement system but there is still power in the mains cable and power supply unit. To fully disconnect from mains power, remove the mains power plug from the wall socket. Room Configuration After logging into the QUANTIEN™ measurement system, the Select Room window should open (alternatively select the (Setup) Menu, choose Select Room to open the Room window). In the Select Room window a button for each transmitting Wi-Box™ AO transmitter within radio range of the QUANTIEN measurement system is displayed. On each button the identification number of the transmitting Wi-Box AO transmitter is displayed. NOTE: All Wi-Box AO transmitters transmitting in the vicinity of the QUANTIEN measurement system will be displayed. Check that the correct Wi-Box unit is linked to the correct room when you configure each room; each Wi-Box unit has the corresponding identification number printed on the front.

1. To link a Wi-Box AO transmitter to a room, press first the Edit button, and then the Room button with the identification number of the correct Wi-Box AO transmitter. NOTE: The Edit button is not available to all users. Refer to User Settings for more information. (page 35)

2. Press the Name field and enter the Room name (maximum 8 characters). 3. Select Use as default if the QUANTIEN measurement system is placed permanently and this room should automatically be selected at startup.

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4. Press the Accept button to save room settings. For detailed information on Room settings, see Room Setup (page 32). Regional Settings To set language, time zone, date and time go to (Setup) Menu, press System, press Regional. See Regional Settings (page 17) for details. Measure FFR or RFR Warnings and Precautions WARNING: . Do not use the QUANTIEN™ measurement system if it has been dropped, or in any other way exposed to mechanical or electrical damage, or if liquids are suspected to have penetrated the casing or the power supply unit. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data. Contact St. Jude Medical representative or technical support for further instructions. . Do not use the QUANTIEN measurement system if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with). . The operator should not touch QUANTIEN measurement system non-CF connectors (or other non-medical equipment) and the patient or patient leads at the same time. Conductive connection may cause leakage currents to induce ventricular fibrillation. CAUTION: The QUANTIEN measurement system is Type CF equipment and protected against the effects of a discharge of a defibrillator. PressureWire™ guidewire readings may be affected by defibrillation. Recalibrate PressureWire guidewire after defibrillation. After defibrillation restart procedure, i.e. re-zero and re-equalize PressureWire guidewire.

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Live Window

Figure 6. Live Window (Default after Preparation Setup)

Table 11. Explanation of Live Window Interface

1 Information bar (name, patient #, Room ID, system time). 2 Mode selection dropdown menu: . FFR - Fractional Flow Reserve (Default) . RFR - Resting Full-cycle Ratio 3 Heart rate 4 Main graph: Pa, Pd phasic and average pressure traces. Optional ECG signal trace import would appear in the top area of the graph. 5 Trend graph or FFR/RFR graph 6 Pa button: Pa average/systolic/diastolic values; touch for drop-down menu. 7 Pd button: Pd average/systolic/diastolic values; touch for drop-down menu. 8 Equalize touch for drop-down menu. 9 Index value 10 Study summary: Summary list of all measurements in study.

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Table 11. Explanation of Live Window Interface

11 Main function button NOTE: Appearance/function changes depending on current mode. . Zero Pa to zero the AO transducer during preparation step 1. . Connect to connect the PressureWire™ guidewire during preparation step 2. . Equalize to equalize the Pd and Pa during preparation step 3. . Record to start recording during an FFR procedure . Pullback to start recording during a RFR procedure . Stop to end a recording of an FFR or RFR procedure . Cancel to end a snapshot recordings . Live to return to the live window during review or settings menus 12 NOTE: Appearance/function changes depending on current mode. Prep button – returns to the preparation procedure while there is no current recording Mark button – Inserts marker in the recording/pullback only. 13 Vessel selection menu - touch for drop-down menu. 14 Menu bar – move to other menus/windows. NOTE:

. The menu bar is grayed out during procedure recordings. . Some buttons may not be available for all users. Refer to User Settings for more information. (page 35) Depending on the step in the procedure additional buttons/fields may appear AO source not available or not selected (red frame).

Time equalize function failed or is turned off and may affect the accuracy of the calculated index (yellow)

Color Coding Red represents the Pa measurement on the screen. However, a red frame around any of the boxes on the right indicates an error. See Troubleshooting for more information (page 47). Green lines on the graph represent Pd measurements. Yellow lines on the graph represent Pd/Pa or FFR measurements. However, a yellow frame around any of the boxes on the right indicates an error. See Troubleshooting for more information (page 47). Blue lines on the graph represent RFR measurements. During setup the Pd and Pa buttons display status information, the colors of the frame indicate status changes. Red frame indicates connection/signal lost, yellow frame indicates that setup is needed and green frame flashes during connection/zeroing etc. FFR/RFR Measurement Procedure NOTE: Reference the IFU for the PressureWire™ guidewire for complete instructions

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on the FFR/RFR procedure. Overview of a measurement procedure: 1. Start system, log into system and select room 2. Select or create new patient 3. Zero the aortic pressure transducer 4. Connect the PressureWire guidewire 5. Equalize Pa and Pd pressures 6. Select recording mode 7. Perform an FFR recording or an RFR pullback 8. Review and annotate measurement recording 9. Export Data

Start System and Select Room Preparations Observe normal sterile procedures if the equipment is used within the sterile zone. This includes covering the QUANTIEN™ measurement system in sterile plastic and keeping the remote control in a sterile plastic bag. Please refer to Cleaning (page 68) for further instructions on cleaning of the QUANTIEN measurement system. Start System and Select Room Ensure that the QUANTIEN™ measurement system is connected to mains socket and turn on the device, the Select Room screen will be displayed after logging into the system. Select the room to be used by touching the corresponding Room button. NOTE: If the room has been set as default this screen will not be displayed. For detailed instructions, refer to Room Setup (page 32). Select or Create New Patient After room selection the Patient window is displayed. There are three optional ways to create or select a patient for the new study: 1. Create new patient: Touch + New Patient and enter the patient information manually. NOTE: You must create a new patient when logged in as a Guest. See User Settings for more information (page 35).

2. Create New Study for existing patient: Open the Archive window, choose an existing patient entry and choose New Study.

3. Select patient from DICOM Worklist: Select a patient entry and choose New Study. For detailed information on DICOM settings and worklist query, see Network Configuration (page 41). After patient selection the Live window will be displayed. Verify measurement settings, see Display Settings (page 44). CAUTION: An insensitive or overly sensitive averaging of pressure may result in an

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incorrect value; see Display Settings (page 44).

Zero the Aortic Pressure Transducer The preparation screens can be used to guide you through the procedure set up. If the guide is used, follow the instructions on screen. Activating/deactivating the guide is done in the (Setup) Menu, Display menu, Other. 1. Place the AO transducer at heart level. 2. Open the AO transducer manifold to air. 3. Press the Zero Pa button. When the text on the Pa-button changes to Zero OK close the transducer manifold (open to patient).

Figure 7. Zeroing the Pa

Connect the PressureWire™ Guidewire 1. Unpack PressureWire™ guidewire using regular sterile routine. Leave the PressureWire guidewire in the packaging coil. Place the packaging coil flat on the table.

Figure 8. Preparing the PressureWire™ Guidewire

1. Flush the packaging coil with saline solution through the luer connector. 2. Continue with either a wireless or cable connected PressureWire guidewire - A PressureWire™ wireless guidewire: Press the Pd button in the drop-down menu; press Connect (or in the FFR guide press

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Connect Wireless). Turn on the PressureWire™ transmitter. The transmitter will connect to the QUANTIEN™ measurement system and zero PressureWire guidewire.

Figure 9. Turn on the PressureWire™ Guidewire

Alternatively: - A PressureWire™ cable-connected guidewire: Insert the PressureWire cable connector into PressureWire IN. The PressureWire guidewire is automatically zeroed. NOTE: Refer to Additional Devices and Accessories for the compatible PressureWire guidewires. (page 7)

Equalize Pa and Pd Pressures 1. Insert the PressureWire™ guidewire in the guiding catheter and advance it until the sensor element of the PressureWire guidewire is just outside the tip of the guiding catheter.

Figure 10. Advance PressureWire™ Guidewire

2. Make sure the AO transducer is positioned at the same height as the patient’s heart. Press Equalize, and again press Equalize on the drop down button (or using preparation screens for guidance, press Equalize once in the guide area). When equalization is completed: Pa and Pd buttons should display identical values; the Pd/Pa value should be 1.00.

Recording Mode Select the recording mode from the recording mode dropdown menu.

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Figure 11. Select Recording Mode

Table 12. Study Options by Recording Mode

Recording Type Snapshot Type FFR Record Pd/Pa RFR Pullback RFR

FFR Recording The system is now ready to measure FFR. 1. Advance the PressureWire™ guidewire distal of the lesion. 2. Use standard cath lab techniques to induce maximum hyperemia. 3. Press Record on the main function button to start recording. 4. Record until a steady state maximum hyperemic condition is reached, or until the hyperemic effect starts to decrease.

5. To place a marker in the recording at any time, press the Mark button. 6. Press the Stop button (main function button). The recording is automatically saved and the Review window is opened.

RFR Pullback The system is now ready to measure RFR. 1. Advance the PressureWire™ guidewire distal of the lesion. 2. Press Pullback on the main function button to start recording. 3. Record the region of interest. 4. To place a marker in the recording at any time, press the Mark button. NOTE: When there is a decrease in the RFR value during a pullback raw data will not be displayed. A different color in the graph will indicate the previous highest recorded value.

5. Press the Stop button (main function button). The recording is automatically saved and the Review window is opened.

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Snapshot Recordings 1. Advance the PressureWire™ guidewire to the desired location. 2. Press the camera icon in the RFR or FFR measurement box.

Figure 12. Location of Camera Icon

The measurement window will change to a status bar to count the next five heartbeats. NOTE: The cancel button is active to exit the snapshot progress.

Figure 13. Status Bar

After the snapshot recording, the recording is automatically saved, and the review window is opened.

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Review Recordings Review Window

Figure 14. Review Window

Functions not described in the table below are found in the section, Live Window (page 18).

Table 13. Review Window

1 Primary cursor (yellow for FFR and blue for RFR): Indicates the position where the pressure values and index value are taken from. Hold cursor to select and move. Tap the label to change type or remove. 2 Optional secondary cursor (white): location of a mark placed during recording or review. 3 Index value box: Indicates the index value at the cursor position. 4 Study Summary button: Summary list of recordings in study. Press to open Study list (… indicates additional recordings). . Yellow for FFR recordings . Blue for RFR pullbacks 5 Main function button: Return to Live window 6 Annotation bar: Open Annotation window 7 Recording number indicator (in Review mode) with time field (recording starting time) 8 Review tools bar: Return. Cursor will move back to the last saved lowest value for the currently select cursor. Cursor position is saved when leaving to a new menu.

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Table 13. Review Window

Zoom in

Zoom out

Cursor button selected: the arrow button moves the cursor to the left. Cursor button unselected: the arrow button moves the graph to the left.

Toggle between moving the Cursor and moving the entire timeline.

Cursor button selected: the arrow button moves the cursor to the right. Cursor button unselected: the arrow button moves the graph to the right.

Add Secondary Cursor button

Export button. Export recording. Only visible in Study list.

Delete button. Delete recording. Only visible in Study list.

Study Summary

Figure 15. Study Summary Box

1. Time stamp 2. Type of study 3. Index value 4. Vessel

NOTE: PBK indicates a RFR pullback recording. Review Recording The Review window displays the recording with a primary cursor line (colored) indicating the index value. An additional secondary cursor in white can be added. The primary cursor is automatically set to the recording cycle minima upon entering Review mode. For generic recordings, the default cursor type is FFR. For snapshot recordings, the default cursor type will correspond with the index of the snapshot recording.

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CAUTION: The system may place the cursors at the wrong location (value) due to artifacts in Pa or Pd pressure. The responsible physician should confirm that the point selected by the system is a valid point for the selected index. NOTE: When there is a decrease in the RFR value during a pullback raw data will not be displayed. A different color in the graph will indicate the previous highest recorded value. Adjustments: . Review the recording and place the index cursor by moving the cursor with a finger or the arrow buttons. If necessary, reposition the cursor at a new position to calculate a new index value. The recording will be updated with the adjusted index value. . Add an additional secondary cursor to view an additional index at another point in the recording. Annotations: . Annotations are entered via the Annotation button. Select the annotation for Vessel, Step and Drug from the respective lists. A free text comment can also be added. Use the Accept button to save entries. Review other recordings in study: . All recordings in a study are listed on the Study Summary button with procedure time, the index of primary cursor, and a shortened version of the added annotations. The primary cursor is displayed on top. . Touch the Study Summary button to expand a list of all the recordings in the study. Select the recording of interest for review, delete or export it using the Delete or Export buttons, see Export Data (page 28). . Press the Live button to return to the Live window to perform a new measurement for the same patient or select a new patient to start a new study. RFR-FFR Hybrid Method Result Interpretation The following gray zone and the criteria for determining positive (ischemia causing), negative (non-ischemia causing) is used for RFR result interpretation: . RFR < 0.86: Positive (ischemia causing) . 0.86 ≤ RFR ≤ 0.93: Gray zone, decision will be based on FFR - FFR ≤ 0.8: Positive (ischemia causing) - FFR > 0.8: Negative (non-ischemia causing) . RFR > 0.93: Negative (non-ischemia causing) Summary of RFR Validation Study The RFR hybrid approach studied in coronary arteries demonstrated 93.6% diagnostic accuracy, 91.3% percent positive agreement, 95.8% percent negative agreement, 95.2% positive predictive value (PPV), and 92.3% negative predictive value (NPV) when compared to FFR using a cut-off of 0.80. The RFR hybrid approach spared 55.5% of the lesions and 50.8% of the patients from the use of hyperemic agents. The result showed comparable diagnostic accuracy, percent positive agreement, percent negative agreement, PPV, and NPV values between RFR-FFR and iFR-FFR hybrid approaches.

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Table 14. Summary of RFR Validation Result

RFR-FFR iFR2-FFR Diagnostic Accuracy 93.6% (469/501) 92.2% (462/501) [91.1%, 95.6%] [89.5%, 94.4%] Percent Positive Agreement 91.3% (219/240) 88.8% (213/240) [86.9%, 94.5%] [84.1%, 92.5%] Percent Negative Agreement 95.8% (250/261) 95.4% (249/261) [92.6%, 97.9%] [92.1%, 97.6%] PPV 95.2% (219/230) 94.7% (213/225) [91.6%, 97.6%] [90.9%, 97.2%] NPV 92.3% (250/271) 90.2% (249/276) [88.4%, 95.1%] [86.1%, 93.5%] Diagnostic Accuracy Outside the Grey Zone 88.5% (246/278) 86.8% (256/295) [84.1%, 92.0%] [82.4%, 90.4%] Lesions free from Hyperemic Agents 55.5% (278/501) 58.9% (295/501) [51.0%, 59.9%] [54.4%, 63.2%] Patients free from Hyperemic Agents 50.8% (219/431) 54.3% (234/431) [46.0%, 55.6%] [49.5%, 59.1%] Export Data NOTE: Patient information will not be encrypted. Data export is managed from the Review window or from the Archive window. In the Review window, use the Study Summary button to open the list of recordings. Select the recording of interest and press the Export button. The Export dialogue window will appear (see figure below). Using the Export button in the Archive window will also open the same window. Grayed out box if export method not accessible.

2 iFR was computed using the algorithm described in Van't Veer M, Pijls NHJ, Hennigan B, Watkins S, Ali ZA, De Bruyne B, et al. Comparison of Different Diastolic Resting Indexes to iFR: Are They All Equal? J Am Coll Cardiol. 2017;70(25):3088-96.

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Figure 16. Export Menu

Select destination: 1. Network Path. Requires network connection and setup 2. USB Memory. Requires memory stick inserted in USB port WARNING: Any USB memory stick used must be port powered if connected to the QUANTIEN™ measurement system in the patient's vicinity or it may compromise electrical isolation and cause patient injury. It is not allowed to electrically connect the USB device to other devices.

3. DICOM Archive. Requires network connection and DICOM setup Select format: 4. Internal. QUANTIEN measurement system internal raw data format. Compatible with RadiView™ PC software (requires activated compatibility mode).

5. Spreadsheet. Raw data in tab delimited text file (.txt). Compatible with standard spreadsheet software such as MS Excel3‡.

6. Picture. The QUANTIEN screen as standard picture (.PNG). 7. Export All Recordings in Study. Check this box to export all recordings in study to the selected destination and in the selected format. Select the Accept button to export. Select the Cancel button to leave the dialogue box without exporting. The QUANTIEN measurement system can be configured to automatically export data after a recording has been reviewed.

3 Excel is a trademark of Microsoft Corporation.

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NOTE: . To use the Network and DICOM alternatives these need to be configured, see Network Configuration (page 41). . A copy of the recording will remain in the system memory after export. To remove a recording it must be deleted. Review Archived Studies NOTE: Reviewing archived studies is unavailable when signed in as a Guest. Structure of the archive: The recordings in the archive are filed under different studies. A study consists of all recordings for the same patient on one occasion. If new recordings are made for that patient at a later date a new study will be created. An unnamed default patient without recordings will automatically be deleted at instrument restart. Archive Window The Archive window has two appearances: List of Studies and List of Study Recordings. The List of Studies window is shown in the upper half of the figure below. The list can be sorted by any heading; the heading marked with an arrow is the one currently used. Select the View button for the study of interest. The View button will be visible when a patient row is selected. The window will open a list of all recordings in that study.

Figure 17. Patient List in Archive Window (with a patient selected)

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Table 15. Archive window buttons/symbols

Buttons/Symbols Name/Explanation

Edit: Edit patient name, ID, date of birth and gender.

View: Display List of Recordings for the selected study.

Storage Space: Displays remaining memory. Press to open Storage Space window (see Export and Delete Files in Archive (page 31)). Free-up Storage Space: Free up storage space by deleting old recordings, (see Free-up Storage Space (page 31)).

Left Arrow: Return to List of Studies.

Right Arrow: Open recording in Review window.

Search: Open search dialogue. Set parameters and press Accept button to initiate search.

New Study: Create new study with current Patient.

Export of recording OK.

Export of recording FAIL (Red).

Local file has been updated after the file was exported (Yellow).

Export and Delete Files in Archive Open recording for review: Press Right Arrow button Delete recording: Press Delete button (bin) Export recording: Press Export button (see Export Data (page 28)) Use the New Study button to start a new study for the current patient. Free-up Storage Space The QUANTIEN™ measurement system is not intended for long-term archiving. The Storage Space box in the archive window displays remaining storage space as a percent of total memory. The system is equipped with an internal memory of approximately 800 MB. To keep the system response time short it is recommended to export and/or delete old recordings continuously. After 500 saved recordings the system will display "Removing unused studies will shorten loading time." Free-up System Memory 1. Press Storage Space in the Archive window. 2. Press Free-up Storage Space to quickly free up storage space by deleting 20% of the

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storage space, starting with the oldest recordings. It is best not to free-up storage space until prompted by the system. NOTE: There is about 800 MB of storage and every time Free-up Storage Space is used, 20% of that will be erased. How many recordings that will be deleted depends on the length of the recordings. Settings System Settings Overview Select room window – see Room Setup (page 32) (Setup) Menu: System menu – see Regional Settings (page 17), Connections (page 37), and Network Configuration (page 41) Display menu – see Display Settings (page 44) Service menu – see Service (page 46)

Table 16. System Settings Menus and Submenus

Display System Service − Sweep speed − Info − Barometer compensation − ECG − Network − Upgrade/Save Setup changes − Pressure − DICOM − Calibrate screen − Trend graph − Export − Export log files − Brightness − Regional − Time equalize − Video output − Security − Other − Other Room Setup The QUANTIEN™ measurement system handles different room configurations in the Select Room window. This window is displayed immediately at startup or is reached through the (Setup) Menu. When a room has been selected the Patient window is automatically displayed. To leave the Select Room window and open Setup without selecting a room, press Skip. If a room configuration has been selected as default the Select Room window will not be displayed at startup.

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Select Room Window

Figure 18. Select Room Window

The figure above shows an example of a Select Room window with seven different rooms.

Table 17. Explanation of buttons and symbols in the Select Room Menu

1 Select Room menu 2 Edit Room 3 Add Room 4 Skip Room setup "Room A" Identification name of the room (or Not Set) "Wi-Box" + number The Wi-Box™ AO transmitter within radio range of the QUANTIEN™ measurement system+ ID number of Wi-Box device AUX IN 1 Room configured for AO pressure via cable A Wi-Box AO transmitter transmitting (blue symbol). The number of blue lines indicates the signal quality. No radio contact with a Wi-Box AO transmitter (red cross)

Room lock; Room set as default

Start Demo Mode. Activate demo mode

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Add/Delete Room At initial setup: . The window will be empty if no Wi-Box™ AO transmitter is within radio range. Touch + Add to add and configure a new room. . If one or more Wi-Box AO transmitters are turned on and within radio range, the QUANTIEN™ measurement system will display a room button for each Wi-Box AO transmitter with the identification number of the Wi-Box device. Push Edit and then the Room button to configure one room at a time. . If no powered Wi-Box AO transmitter is present or within radio range, a new room will have to be setup manually.

Figure 19. Room Button Menu

1. Name for Room 2. Use as Default

Add/Edit Room: . Touch Name field and type a room name (maximum 8 characters). . Confirm that the Wi-Box AO transmitter identification number matches the number printed on the Wi-Box unit in the current room. . Touch the AO button to select cabled analog input AO source. Refer to Connect AO Via Analog Input AUX IN 1 (page 38), for configuration of analog input as source for AO pressure. Optional: Select the AUX button to configure analog input/output channels: In 2 Import ECG signal (see Connect ECG Via Analog Input AUX IN 2 (page 40)). Out 1 and Out 2 Export Pd, Pa or Reference signal (see Configure Analog Output Ports AUX OUT 1 & 2 (page 40)). . Select Use as Default to make a room setup default at system startup. When one room is set as default the Select Room window will be bypassed at start up and the Patient window will be displayed directly. This setting is preferred when the QUANTIEN measurement system is permanently installed in a room. If the QUANTIEN measurement system is intended for mobile use, configure all rooms where it

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will be used as described above. A maximum of twelve rooms can be configured. The system is then ready to be used for an FFR measurement procedure. Regional Settings Set User Interface Language The user interface language is changed in (Setup), System, Regional menu. Select the Language version from the available options. Save settings with the Set Language button. The QUANTIEN™ measurement system must be restarted after each setting in order for the change to take effect. Set Time Zone/Date Time zone, Date and time are set in (Setup), System, Regional menu: . Set correct Time zone. Save settings with the Set button. . Set correct Date and select format. Save settings with the Set button. . Set correct Time and select format. Save settings with the Set button. The QUANTIEN™ measurement system will restart after each operation in order for the changes to take effect. If only the format is changed no restart is required. NOTE: A correct time zone, time and date are important since all recordings are labeled using current time and date. This is especially important if setup includes communication with DICOM.

User Settings The QUANTIEN™ measurement system has four types of Users who can access the system: 1. Site administrator (Site Admin for short) The site administrators can: a. Add, remove, promote, or demote users. See User Administration for more information. (page 36) b. Change all user passwords c. Perform procedures 2. User Users can change their own passwords and perform procedures. 3. Guest Guest users are the most restricted: a. The main screen will only allow you to select room and logout. b. The System Setup screen will only display Institution and Equipment. c. Cannot edit any room setting. d. Cannot access the DICOM server. e. Cannot search or refresh the Patient menu. f. Can only view studies that were created in the current session in the Archive menu. g. Can only export studies from the current session.

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4. Service Service users are able to perform maintenance procedures. User Administration NOTE:

. Only a Site Admin user can make changes to user profiles. . Contact St. Jude Medical service if the site admin has forgotten their password. To add a user: 1. Select Users from the Setup menu. 2. Touch the Add User button. 3. Enter the user's name. 4. Set the user's initial password. To delete a user: 1. Select Users from the Setup menu. 2. Select the User from the User screen. 3. Touch the Delete User button. To promote a user to Site Admin: 1. Select Users from the Setup menu. 2. Select the User from the User screen. 3. Touch the Promote User button. To demote a Site Admin to a user: 1. Select Users from the Setup menu. 2. Select the User from the User screen. 3. Touch the Demote User button. To change a user's password: 1. Select Users from the Setup menu. 2. Select the User from the User screen. 3. Touch the Change Password button. 4. Enter the initial password for the User. To unlock a user: 1. Select Users from the Setup menu. 2. Select the User from the User screen. 3. Touch the Unlock User button. Security Settings Only the Administrator can make changes to the following security settings:

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NOTE: St. Jude Medical has preloaded the QUANTIEN™ measurement system with the recommended values for the security settings. . Password policy - Enforce password history - Maximum password age (days) - Minimum password length (characters) - Password must meet complexity requirements NOTE: Passwords should be at least 7 characters and contain 3 of the following:

. A lowercase character . An uppercase character . A number . A symbol or special character . Account lockout policy - Account lockout threshold - Account lockout duration (minutes) . Inactivity timeout - Timeout period (minutes) Connections Installation - Warnings and Precautions Warnings . External equipment intended for connection to the QUANTIEN™ measurement system shall comply with relevant IEC standard (e.g., IEC 60601 series for medical electrical equipment). In addition, all such combinations of systems shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. Any person who connects external equipment to signal output, or other connectors, has formed a system and is therefore responsible for compliance of the system with these requirements. If in doubt, contact a qualified technician, or alternatively, a St. Jude Medical representative/technical support. . No modification of this equipment is allowed. . Do not open or remove access covers on the QUANTIEN measurement system unless specifically instructed by St. Jude Medical technical support to do so. . The AUX inputs/outputs are isolated with one means of operator protection (MOOP); see the Isolation Diagram (page 78). External equipment which is connected to these inputs/outputs must provide isolation against leakage current. The user is responsible for compliance with the requirements of standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. Cautions . Do not connect patient applied parts to AUX IN/OUT analog ports. . Output sensitivity changes should be performed by a qualified technician. Incorrect settings may result in discrepancies between monitor system and QUANTIEN™ measurement

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system values. The numbers referenced in each section are those used in the figure in section, Product Interface and Symbols (page 3); consult this figure to locate the different ports. Each section ends with information on where the software settings for each connection are made. Connect AO Via Analog Input AUX IN 1 Connection: The AO signal may be imported to the QUANTIEN™ measurement system from a HRS. Connect an AUX IN cable between an analog output port on the recording system and AUX IN 1 (Product Interface and Symbols (page 3)) on the QUANTIEN main unit. The cable used must be compatible with the specific HRS. Setup: Setup is performed in: Select Room, New Room / Edit Room, AO: AUX 1, Zero and Calibrate. Before an FFR measurement is performed the AO signal must be zeroed and calibrated. After selecting the AO button and selecting AUX 1 in the list of AO sources (see figure below), you will be prompted to Zero and Calibrate the AO input signal.

Figure 20. AO Button Menu

1. Zero and Calibrate 2. Zero Status 3. Calibration Status 4. Nominal Sensitivity - Select Nominal Sensitivity, a value between 50–200 (specific for each recording system)

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- Press Zero and Calibrate – the Dialogue box in the figure below opens. - Make sure that the AO pressure channel on the cath lab HRS is zeroed. - Press the Zero button in the left column. The AO signal is now zeroed.

Figure 21. Zero and Calibrate AO

1. Zero Status 2. Zero Offset 3. Active menu: Zero and Calibrate 4. Nominal Sensitivity 5. Calibration Status 6. Calibration Value 7. Reference Level Default Calibration: . If the sensitivity of the analog output port on the HRS is fixed at 100 mmHg/V the nominal sensitivity can be used. Check the checkbox Use Nominal Sensitivity. Custom Calibration: . For all other system setup or if there is uncertainty regarding the nominal sensitivity, an arbitrary reference level from the HRS may be used to calibrate the AO pressure input port. . Enter the reference level used from the HRS in the field Reference Level (mmHg) and press the Calibrate button. The system is now calibrated and ready to receive AO pressure from the HRS. The calibration factor and date are saved for future reference.

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Connect ECG Via Analog Input AUX IN 2 An ECG signal may be imported from the HRS and displayed in the Live window on the QUANTIEN™ measurement system. Connection: Connect an AUX IN (ECG) cable between an analog ECG output port on the HRS and AUX IN 2 (Product Interface and Symbols (page 3)) on the back of the QUANTIEN main unit. The cable used must be compatible with the specific HRS. Setup: Setup ECG in: Select Room, New Room / Edit Room, AUX IN 2 ECG Configuration: . Scale button. Select ECG scale. . Select Display Trace checkbox to display ECG signal. . Select Baseline Filter checkbox to enable high pass filter for baseline drift removal. Connect PressureWire™ Output to Recording System WARNING: The PressureWire™ OUT output provides isolation according to defibrillation proof type CF (see figure Isolation Diagram (page 78)). External equipment which is connected to this output must provide isolation against leakage current. The user is responsible for compliance with the requirements of standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3§16, ME SYSTEMS. Connection: To display Pd pressure on a HRS connect a monitor cable from PressureWire OUT (Product Interface and Symbols (page 3)) to a free input port on the HRS. Configuration: To ensure equal pressure readings on the HRS and the QUANTIEN™ measurement system, the associated input port must be zeroed. Zero the associated input port after PressureWire™ guidewire has been zeroed on the QUANTIEN measurement system and before inserting PressureWire guidewire into the patient, or by using the static 0 mmHg reference output setting in (Setup) Menu, System, Other, PW Reference out. Settings: . Pd – Distal pressure from wireless or cable connected PressureWire guidewire . 0 mmHg – static 0 mmHg reference pressure . 100 mmHg – static 100 mmHg reference pressure Configure Analog Output Ports AUX OUT 1 & 2 Connection: AUX OUT 1 and AUX OUT 2 (Product Interface and Symbols (page 3)) are analog output ports enabling connection of external measurement devices using an AUX out cable. Configuration: Select Room, New Room / Edit Room, AUX OUT 1 or 2 Settings: . Pd – Distal pressure from wireless or cable connected PressureWire™ guidewire . Pa – Proximal pressure from AO transducer . Reference voltage levels: 0V; 1.0V; 1.5V

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Connect Video Out to External Monitor WARNING: The DVI-I output is not isolated. External equipment which is connected to this output must provide isolation against leakage current. The user is responsible for compliance with the requirements of standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. The DVI-I (Integrated) video output port enables the QUANTIEN™ screen to be displayed on an existing cath lab monitor or external slave monitors. Screen resolution of QUANTIEN main unit: 1280x800. Connection: Connect the video port on the receiving monitor/equipment to the DVI-I port (Product Interface and Symbols (page 3)) on the bottom panel of the QUANTIEN main unit using a standard video cable. NOTE: The QUANTIEN measurement system will automatically detect the external monitor's resolution.

Export Recordings to USB Memory Stick . Connect a regular USB memory stick to the USB port (Product Interface and Symbols (page 3)). . Use the Export button in either the Review or Archive window to export data to the USB device, see Export Data (page 28). WARNING: Any USB memory stick used must be port powered if connected to the QUANTIEN™ measurement system in the patient´s vicinity or it may compromise electrical isolation and cause patient injury. It is not allowed to electrically connect the USB device to other devices.

Network Configuration Configure General Network Settings WARNING: The ethernet patch cable with isolation box must be used to assure proper isolation as the ethernet outlet is not isolated. The short patch cable shall be positioned between the isolation box and the main unit. The user is responsible for compliance with the requirements of standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. CAUTION: Direct connection to a non-secure network, like the internet, may interfere with correct operation and/or result in inappropriate access to patient information. Furthermore, it should be noted that reconfiguring a used network may lead to inability to import patient as well as export examination data, ultimately leading to a risk of loss of patient and examination data. To avoid this problem St. Jude Medical recommends verifying network settings in the system setup after each change. NOTE: Please note that St. Jude Medical makes no representation of warranty that use of the QUANTIEN™ measurement system complies with applicable privacy, security and confidentiality laws, but encourages you to assess your own risk as you use, disclose, control, process or transfer patient health information with this system.

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Overview: Connecting the QUANTIEN measurement system to a network will allow data export for remote review or archiving, communication with a DICOM server for import of a DICOM worklist and screen image export to DICOM compatible archives. Connection: 1. Connect the ethernet patch cable with isolation interface, provided with the QUANTIEN measurement system, to the ethernet port (Product Interface and Symbols (page 3)).

2. Connect a standard network (RJ45) cable between a hospital network port and the isolation interface. Configuration: Setup, System, Network Required information: . Hostname: Manually enter a local name for QUANTIEN measurement system . IP Address: Option to enter manually or to obtain automatically . Subnet Mask . Gateway . Primary DNS Server Press Apply to apply network settings. Configure Data Export Enter (Setup) Menu, System, Export Network Path Configure the network path to which the QUANTIEN™ measurement system will export data, either manually or automatically. Requires a functional network connection. Annotation: //"server name"/"folder X"/"folder Y". If backslash (\) is used instead of slash (/), the system will automatically change them. . Export path: Network pathway . User name: Network user name with read/write access rights . Password: Network user password Press the Verify button to verify that the connection is working. Export to Compatibility Mode Data can be exported in a format that is compatible with RadiView™ software version 2.2 and earlier. For versions later than 2.2, the checkbox can be deselected to allow more information to be displayed in RadiView software. Auto Export Activate/de-activate automatic data export. Select to which destination and in which format the QUANTIEN™ measurement system will save recordings as soon as they are completed after review. Destinations: . Network Path: Export data to the configured network path . DICOM Archive: Export data to the configured DICOM Archive

State: Released Date: 2019.03.06 22:30 GMT

Formats: . Internal, QUANTIEN measurement system internal raw data format. Compatible with RadiView™ PC software (requires activated compatibility mode). . Spreadsheet, raw data in tab delineated text file (.txt). Compatible with standard spreadsheet software such as MS Excel4‡. . Picture, QUANTIEN measurement system screen as standard picture (.PNG). Manual Export Set default settings for the manual export menu in Review or Archive windows. Configure DICOM Worklist Refer to the full DICOM Conformance Statement for the QUANTIEN™ measurement system at sjmprofessional.com for more information on the DICOM protocol used.

Table 18. DICOM abbreviations

Abbreviation Explanation SCU Server Class User AE Application Entity Local AE title Local name for QUANTIEN™ measurement system Remote AE title Remote AE server name

Configure Worklist Server (SCU) Enter (Setup) Menu, System, DICOM, Worklist SCU Setting made here configures the network settings of the QUANTIEN™ measurement system, enabling it to access the DICOM worklist from the remote host. NOTE: Time and time zone have to be correct set for retrieval of worklist from DICOM server. All network and DICOM settings are case sensitive. The following information is required: . Local AE Title (Name of the QUANTIEN measurement system. Might have to be registered on the local network) . Remote AE Title (DICOM server) . Remote Host (Hostname/IP Address) . Remote Port Number . Scheduled Procedure Station Name . Scheduled Procedure Station AE Title . Modality: Select either XA or OT Modality Press the Verify button to apply settings and verify that the connection works. Configure DICOM Worklist Query Enter (Setup) Menu, System, DICOM, Worklist Query Setting made here configures the DICOM Worklist Query and how the results are filtered and displayed on the QUANTIEN™ measurement system.

4 Excel is a trademark of Microsoft Corporation.

State: Released Date: 2019.03.06 22:30 GMT

The following settings are required: Date limitation options - Procedures Scheduled for Today - Procedures in the Range: - Enter number of Days Before Today´s Date - Enter number of Days After Today´s Date - Do Not Consider Date Scheduling options - Procedures Schedule for Modality (the Modality selected earlier is displayed for information) - Procedures Scheduled for AE Title (the AE Title entered earlier is displayed for information) - Procedures Scheduled for Station Name (the Station Name entered earlier is displayed for information) Maximum Retrieved Procedures - Enter value to set maximum number of retrieved procedures.

Configure Export to DICOM Archive Enter (Setup) Menu, System, DICOM, Export Settings made here configures export to a DICOM Archive. The following information is required: . Local AE Title . Remote AE Title . Remote Host (Hostname/IP Address) . Remote Port Number . Modality: Select either XA or OT Modality Press the Verify button to apply settings and verify that the connection works. Institution Name: If required a specific Institution name can be configured in (Setup) Menu, System, Info, Institution. The Institution name will be included in the file information when exporting to DICOM. Display Settings Unless otherwise indicated, settings are entered in (Setup) Menu, Display menu. Sweep Speed Change screen update rate and the level of detail visible to the user. A high sweep speed is suitable when a detailed picture of the tracings is required. A low sweep speed is suitable when displaying slow changes, for instance during intravenous infusion and pressure pullback. NOTE:

. Due to the lower update rate at slow and medium sweep speed, some information may not be fully displayed.

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. The slow sweep is used during RFR pullback regardless of user setting. Options: . Slow (40 seconds/screen) . Medium (20 seconds/screen) . Fast (10 seconds/screen) ECG (AUX IN 2) ECG Configuration . Scale. Select the desired ECG scale. . Select the Display Trace checkbox to display ECG signal in Live Window. . Select the Baseline Filter checkbox to enable high pass filter for baseline drift removal. Pressure . Average: Number of heart beats included in pressure averaging filter. Select 1, 2, 3, 4, 8 or 12 beats. Factory setting: 3 heart beats. Choosing a high number of heartbeats will make the pressure averaging slower and less sensitive to artifacts, but may also result in insensitive averaging which is noticeable when there is a short hyperemic plateau. Choosing a low number of heartbeats makes the pressure averaging faster and more sensitive to pressure changes, which is desirable when using a short hyperemic plateau, but it may also result in an averaging overly sensitive to arrhythmia and pressure disturbances. CAUTION: An insensitive or overly sensitive averaging of pressure may result in an incorrect FFR value. . Scale: Pressure waveform vertical scale. Select -20-80; 0-100; 0-150; 0-200; 0-200, -80-320 mmHg. Factory setting: 0-150 mmHg. . Display Max/Min in Review: Enable indicators for minimum and maximum diastolic/systolic pressure indicators in Review mode. Trend Graph . Display Trend Graph: Turn on/off the lower Trend Graph window . Pd/Pa Scale: Change the scale of the Pd/Pa graph Brightness Increase or decrease screen brightness. Select 20, 40, 60, 80 or 100%. Factory setting is 60%. Other Settings . FFR Set Up Guide: Turn on/off FFR procedure step-by-step guide . Hide Patient Information: Hide patient information on screen. Useful during live case broadcasting. . Max Rec Length (settings in (Setup) Menu, System, Other): - Maximum recording time. If a recording passes max recording time the recording will automatically stop. - "No Limit" - Recording will proceed until the internal memory is full. If the recording is longer than 30 minutes it will be saved in sections, each 30 minutes long. - A warning message will be displayed when the available memory is low.

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. Quick Rec Length (settings in (Setup) Menu, System, Other): 1, 3, or 6 beats. The recording will stop after the selected number of beats and automatically enter Review mode. Service NOTE: The service menu is only available for Service and Site Admin users. PW Sample Loss: Sample loss (%) in the radio transmission when using a PressureWire™ wireless guidewire. A high number may indicate a problem with the radio transmission from the wireless PressureWire™ guidewire. 0 = no radio packages lost AO Sample Loss: Sample loss (%) in the radio transmission when using the Wi-Box™ AO transmitter. A high number may indicate a problem with the radio transmission from the Wi- Box™ unit. 0 = no radio packages lost Barometer compensation: Activate/De-activate Barometric pressure compensation. Default value is ON. Setting will return to default ON when the instrument is restarted. Calibrate Screen If there is a problem with the precision of the touch screen it can be re-calibrated. 1. Touch the Calibrate screen button; this will open a window with a grid. 2. A circle will appear in the corner at the junction of two lines, touch inside the circle and keep finger in place until the circle is filled completely and a beep sounds.

3. A circle will appear at the next junction, touch inside the circle and wait for the sound signal. 4. Continue touching inside each circle that appears in the same way. 5. When no more circles appear the screen is recalibrated and the calibration window will close after a short delay.

Time Equalize Turn time equalization on/off. When activated, the Pa and Pd curve will be time synchronized at equalization. NOTE:

. Turning off the time equalization function may affect the accuracy of the measured index.

. Time equalization is always on for RFR pullback regardless of user setting.

Save Setup Changes (only displayed in demo mode) This will save any system setup changes made in demo mode. Otherwise the system will discard any changes when exiting demo mode. Access the QUANTIEN™ measurement system hardware and software version information in (Setup) Menu, System, Info, Equipment. Demo Mode Select Start Demo Mode from the Select Room window. Press the button in the top, left corner. In demo mode, the top bar will be marked DEMO with a yellow background color in all windows. To exit demo mode, return to the Select Room window and use the same button, now marked Exit Demo Mode.

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When demo mode is activated a pre-recorded sequence of pressure tracings including a hyperemic event is replayed on the screen allowing you to perform the steps of an FFR measurement procedure. Any system setup changes made in demo mode will be discarded when the QUANTIEN™ measurement system is turned off or if you are exiting demo mode to normal mode. The settings can be saved in the Service menu, select Save setup changes. Troubleshooting On Screen Messages The tables below list on screen messages. Messages that are self-explanatory and information of minor importance are not included. Letter in first column indicates type of message. E = Error W= Warning I= Information Message tables: . System on-screen messages (page 47) . AO Source — Wi-Box™ AO transmitter (page 50) . AO Source — AUX IN (page 51) . PW Source — PressureWire™ Wireless guidewire (page 51) . PW Source — PressureWire™ Cable-Connection guidewire (page 52)

Table 19. System on-screen messages

Typ Current Message Reason Action Cancel OK e E "Failed to connect to Request (or Check N/A Acknowledges DICOM peer" query) for settings message and DICOM worklist Check closes window failed, i.e., no network response from connection remote host Check remote host I "There were more patients Query to remote Redefine N/A Acknowledges matching the worklist host contains query message and query available. Use a more records closes window more specific query" than will be displayed W "Patient has When an edited Select Discards Confirms edits studies associated that are patient has Cancel or OK edits and and closes write protected, they will write protected closes window not be updated" studies window

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Table 19. System on-screen messages

Typ Current Message Reason Action Cancel OK e W "Patient has When trying to Select No delete Confirm delete several studies associated, delete a patient Cancel or OK and close and close mark the ones you wish to who has more window window delete in the list below" than one study in the archive I "Export failed" Export failed Check N/A Confirm settings for export jobs. Check network connection Check USB W "Register new patient?" Changing the Select Continue Yes: Switches PressureWire™ Cancel, Yes with the to Patient guidewire for an or No current Screen active patient PressureWire No: Changes guidewire. the Close PressureWire window guidewire but keeps the current patient W "A patient is registered? Entering demo Select Cancel Continue to Do you wish to proceed mode with an Cancel or OK operation enter demo anyway?" active patient and close mode, close window window E "Failed to load recording Header file is Contact N/A Acknowledges header. File is missing or missing or St. Jude message and corrupt." corrupt, e.g. Medical closes window with checksum error. E "Failed to load recording Data file is Contact N/A Acknowledges data. File might be missing or St. Jude message and corrupt." corrupt, e.g. Medical closes window with checksum error. E "Failed to load recording Data file is Contact N/A Acknowledges data. Unable to locate missing or St. Jude message and data file." corrupt, e.g. Medical closes window with checksum error.

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Table 19. System on-screen messages

Typ Current Message Reason Action Cancel OK e E "Network update failed. Failed to write Contact N/A Confirm and Failed to save network network St. Jude close window settings to file system" settings to the Medical appropriate file. File is missing or corrupt. E "Network update failed. Failed to read Contact N/A Confirm and Failed to retrieve network network St. Jude close window settings." settings from Medical the appropriate file. File is missing or corrupt. E "Network update failed. Network not Check N/A Confirm and Failed to connect to available or network close window network with new settings" network settings settings not Check correct. network connection I "No response on echo Failed to verify Check N/A Confirm and request" settings for settings close window DICOM SCU I "No response on echo Failed to verify Check N/A Confirm and request" settings for settings close window DICOM export I "Failed to write image to Export to Check N/A Confirm and DICOM peer" DICOM archive settings close window failed I "Could not connect to Failed to verify Check N/A Confirm network path" settings for settings for network path. network Settings Check incomplete or settings for missing network path Check network connection

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Table 19. System on-screen messages

Typ Current Message Reason Action Cancel OK e I "Failed to access to Failed to use Check N/A Confirm network path" settings for settings for network path. network Settings Check incomplete or settings for missing or no network path network Check connection. network connection E "Hardware initialization One or several Select N/A Continue failed. Contact your local of the hardware "Override" or startup St. Jude Medical modules for turn off (button text representative" PW, AO or AUX system "Override") initialized with error at startup E "The application failed to Upgrade failed Turn off the N/A N/A upgrade one or several instrument devices. The instrument Contact will not function until an St. Jude upgrade process has been Medical completed. Switch the instrument off and on again to retry." E "The main application Main Turn off the N/A N/A binary has an invalid Application instrument checksum. It has been corrupt Contact damaged or corrupted. St. Jude Please reinstall the Medical system" E "System settings was not System setting Contact N/A Confirm loaded properly, file is files damaged St. Jude missing or corrupt. All or missing. Medical settings have been reverted to default values."

Table 20. AO Source — Wi-Box™ AO Transmitter

Type Current Message Event Action (on Pa button)

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Table 20. AO Source — Wi-Box™ AO Transmitter

Type Current Message Event Action (on Pa button) E No communication with Turn Wi-Box unit on (Red frame) the Wi-Box™ AO Remove reason for transmitter interruption/breakage of (Signal Lost) communication Select a room with a working Wi-Box unit E Faulty signal/data from Restart Wi-Box unit (Red frame) Wi-Box AO transmitter Restart System Contact St. Jude Medical (Wi-Box Error) E AO USB missing Restart System (Red frame) AO USB reports error Contact St. Jude Medical

(Pa Interface Error) E Pressure transducer not Prepare for zeroing (Red frame) open to air when zeroing Zero Zeroing offset out of (Pa Zero failed) range

Table 21. AO Source — AUX IN

Type Current Message Event Action (on Pa button) E AUX missing Restart System (Red frame) AUX reports error Contact St. Jude Medical (Pa Interface Error) E Pressure transducer Prepare for zeroing (Red frame) not open to air when Zero zeroing (Pa Zero Failed) Zeroing offset out of range

Table 22. PW Source — PressureWire™ Wireless Guidewires

Type Current Message Event Action (on Pd button)

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Table 22. PW Source — PressureWire™ Wireless Guidewires

Type Current Message Event Action (on Pd button) W Automatic zeroing after Ensure the (Yellow frame) successful mate failed PressureWire™ guidewire is correctly prepared (Pd Not Zeroed) Try to connect again W The PressureWire Replace the (Yellow frame) transmitter is running PressureWire low on battery guidewire E The system cannot Ensure that the (Red frame) connect to the PressureWire PressureWire transmitter is turned guidewire on at the appropriate (Pd Connect failed) time Ensure that it is not too far away from the system E Communication with Turn the PressureWire (Red frame) the PressureWire guidewire on guidewire Remove reason for broken/interrupted (Pd Signal Lost) interruption/breakage The PressureWire of communication wireless guidewire turned off E The PressureWire Restart System (Red frame) interface missing Contact St. Jude The PressureWire Medical (Pd Interface Error) interface reports error E The PressureWire Ensure the (Red frame) guidewire not PressureWire positioned correctly guidewire is correctly (e.g., inserted in the prepared and (Pd Zero Failed) blood flow) when positioned zeroing Try to zero again

Table 23. PW Source — PressureWire™ Cable-Connection Guidewire

Type Current Message Event Action (on Pd button)

State: Released Date: 2019.03.06 22:30 GMT

Table 23. PW Source — PressureWire™ Cable-Connection Guidewire

Type Current Message Event Action (on Pd button) W Automatic zeroing after Ensure the (Yellow frame) inserting connector PressureWire™ cable- failed connection guidewire is correctly prepared (Pd Not Zeroed) Try to connect again E Sensor has been Reconnect the sensor (Red frame) disconnected from the QUANTIEN™ measurement system (Pd Sensor Disconnected) E The actual wire has Reattach the wire to (Red frame) been disconnected the proximal cable from the proximal cable (Pd Wire Disconnected) E The PressureWire Replace wire (Red frame) cable-connection guidewire is reporting error (Pd Sensor Error) E Cable connecting the Plug in cable (Red frame) PressureWire interface Contact St. Jude to the QUANTIEN Medical main unit missing or (Pd Interface Error) disconnected E The PressureWire Ensure the (Red frame) cable-connection PressureWire cable- guidewire not connection guidewire positioned correctly is correctly prepared (Pd Zero Failed) (e.g., inserted in the and positioned blood flow) Try to zero again Tracing EM Interference The QUANTIEN™ measurement system uses digital signal processing techniques that operate in the radio frequency (RF) energy range. The system is therefore susceptible to interference generated by other RF energy sources such as medical devices, information technology products, or radio/television transmission towers. Tracing the source of radiated interference can be difficult. In accordance with the standards identified in these Instructions for Use, no interference was observed. However, the trained user must determine if an artifact caused by radiated interference will negatively impact signal quality and the subsequent study results. To help identify the source of electromagnetic interference, ask the following questions: . Is the interference intermittent or constant?

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. Is the interference present if the QUANTIEN measurement system is moved to a different location in the facility? Moving cables or other medical equipment away from the system can reduce electromagnetic interference. Please answer these questions before contacting your service representative. The answers will help a service representative determine if the problem is in the system or in the imaging environment.

State: Released Date: 2019.03.06 22:30 GMT

Troubleshooting Tables Contact St. Jude Medical for correct replacement parts and/or further instructions.

Table 24. General function

Erroneous Possible cause Check Normal function Corrective action function No sign of system The main switch The main switch ON Turn the main functioning is not turned ON switch ON Broken or The power cable Properly Contact St. Jude disconnected connected to a Medical power cable powered outlet and power supply unit Internal failure N/A N/A Contact St. Jude Medical The system stops Internal failure N/A N/A Contact St. Jude during the boot Medical sequence before any text is displayed The system stops Internal failure N/A N/A Contact St. Jude during the boot Medical sequence before HW checks are made The system stops Failure in Cable connection Cable without Contact St. Jude and indicates HW connection to the to the damage and Medical error in PW PressureWire™ PressureWire connected interface unit interface Unit correctly Internal failure in N/A N/A Contact St. Jude the PressureWire Medical interface unit The system stops Internal failure N/A N/A Contact St. Jude and indicates HW Medical error in AO or AUX Erroneous date Internal system N/A Date and time is Set date and and clock battery depleted saved between time. Leave information sessions QUANTIEN™ measurement system on for 90h to fully recharge the battery Date and time is Internal system N/A Date and time is Contact St. Jude not saved after battery saved between Medical recharge malfunction sessions

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Table 25. Remote control function

Erroneous Possible cause Check Normal Corrective action function function No or intermittent Low battery N/A N/A Replace the functioning of the batteries, see remote control Remote Control Battery (page 67) Defect remote Check functioning The system Replace the control unit with another responds remote control unit remote control normally unit Internal failure in N/A N/A Contact St. Jude main unit Medical Ambient light Switch off The system Decrease ambient interference ambient light. responds light intensity or Check functioning normally switch to another ambient light source

Table 26. Pressure signal on QUANTIEN™ measurement system when acquired via Wi-Box AO transmitter

Erroneous Possible cause Check Normal function Corrective action function Wi-Box™ AO Wi-Box unit not Check LED’s of Refer to IFU for Refer to IFU for transmitter not powered on or Wi-Box AO the Wi-Box AO the Wi-Box AO possible to select internal failure in transmitter transmitter transmitter for a room Wi-Box unit Internal failure of Check HW status AO status OK Contact St. Jude AO part in of AO after-self Medical QUANTIEN™ test at power on main unit of QUANTIEN main unit Unable to zero Pa Varying pressure Check that AO AO transducer Open AO pressure transducer manifold is transducer manifold is opened to air manifold to air opened to air Too high or too Check that AO AO transducer is Reposition AO low pressure from transducer is placed level with transducer AO transducer placed on correct patient level Disturbance to Pa Check Pa No variation in Pa Check according pressure signal pressure signal pressure signal. to "Abnormal or for variations absent pressure reading of Pa pressure"

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Table 26. Pressure signal on QUANTIEN™ measurement system when acquired via Wi-Box AO transmitter

Erroneous Possible cause Check Normal function Corrective action function Abnormal or Bad contact in Stress the actual The pressure Replace any absent pressure some of the connection reading will broken cables reading of Pa connectors on mechanically remain correct pressure transducer, interface or monitor cable The Wi-Box AO Check LED’s of Refer to IFU for Refer to IFU for transmitter not Wi-Box unit the Wi-Box AO the Wi-Box AO powered on or transmitter transmitter internal failure in Wi-Box unit Internal failure of Check HW status AO status OK Contact St. Jude AO part in the of AO after self- Medical QUANTIEN test at power on measurement of the QUANTIEN system measurement system Transducer not Connections of Properly Correct the failing connected monitor cable, connected connection properly to the interface cable Wi-Box AO and transducer transmitter Defective Functioning of Normal Replace the transducer or transducer and transducer transducer or transducer transducer function transducer interface cable interface cable interface cable with a HRS Incompatible Specification of Refer to IFU for Choose a transducer the transducer the Wi-Box AO transducer transmitter compatible with the Wi-Box AO transmitter Wrong type of Monitor cable HRS listed for the Replace with a monitor cable compatibility with actual monitor correct monitor the present HRS cable cable Defective monitor Visually check the Strain relief intact, Replace the cable monitor cable no other damage monitor cable

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Table 27. Pressure signal on QUANTIEN™ measurement system when acquired via AUX IN function

Erroneous Possible cause Check Normal function Corrective action function Unable to zero Varying pressure Refer to IFU for Stable pressure Refer to IFU for AUX AO source signal output from HRS on how to signal the HRS on how HRS check pressure to correct output signal pressure output signal Too high or too Refer to IFU for Pressure signal Refer to IFU for low pressure HRS on how to close to zero the HRS on how signal output from check pressure to correct HRS output signal pressure output signal Unable to Varying pressure Refer to IFU for Stable pressure Refer to IFU for calibrate AUX AO signal output from HRS on how to signal the HRS on how source HRS check pressure to correct output signal pressure output signal Too high or too Refer to IFU for Pressure signal Refer to IFU for low pressure HRS on how to close to selected the HRS on how signal output from check pressure calibration level to correct HRS output signal pressure output signal Mismatch Compare selected Pressure signal Select correct between selected calibration level close to selected calibration level calibration level and applied calibration level and applied pressure signal pressure signal from HRS from HRS Unable to zero Pa Varying pressure Check that AO AO transducer Open AO pressure transducer manifold is transducer manifold is opened to air manifold to air opened to air Too high or too Check that AO AO transducer is Reposition AO low pressure from transducer is placed leveled transducer AO transducer placed on correct with patient level Disturbance to Pa Check Pa No variation in Pa Check according pressure signal pressure signal pressure signal to "Abnormal or for variations absent pressure reading of Pa pressure" Abnormal or Bad contact in Stress the actual The Pa pressure Replace the absent pressure AUX IN cable connection signal will remain broken cable reading of Pa connectors mechanically correct pressure Defective AUX IN Visually check the Strain relief intact, Replace the cable cable no other damage broken cable

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Table 27. Pressure signal on QUANTIEN™ measurement system when acquired via AUX IN function

Erroneous Possible cause Check Normal function Corrective action function Internal failure of Check HW status AUX status OK Contact St. Jude AUX part in main of AUX after self- Medical unit test at power on of main unit Wrong type of AUX IN cable HRS listed for the Replace with a AUX IN cable compatibility with actual AUX IN correct AUX IN the present HRS cable cable Abnormal Pressure signal in Normal pressure Refer to IFU for pressure signal HRS signal the HRS on how measured in HRS to correct errors in measured pressure signal Abnormal Refer to IFU for Normal pressure Refer to IFU for pressure signal the HRS on how signal the HRS on how output from HRS to check pressure to correct output signal pressure output signal

Table 28. Distal pressure signal on QUANTIEN™ measurement system when acquired via PW IN

Erroneous Possible cause Check Normal function Corrective function action Connection of Defective See IFU for the N/A N/A sensor fail or PressureWire™ PressureWire unable to zero Pd guidewire guidewire for pressure additional information Failure in PW Unit Test PW IN Test of PW IN Contact St. Jude according to passed without Medical Testing PW IN failure (page 70) Movement of the See Preparations N/A Follow the PressureWire for use in the instructions for guidewire causes PressureWire preparations disturbance to the guidewire IFU signal when connecting or zeroing The PressureWire Position of the The Extract the guidewire is PressureWire PressureWire PressureWire inserted in patient guidewire guidewire is guidewire from outside of patient patient

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Table 28. Distal pressure signal on QUANTIEN™ measurement system when acquired via PW IN

Erroneous Possible cause Check Normal function Corrective function action The PressureWire Connections of the Properly Correct the guidewire not proximal connected failing correctly connector and the connection connected. E.g., PressureWire connector not dry, interface unit connector not fully connector inserted or connector damaged Abnormal or Defective See IFU for the N/A N/A absent pressure PressureWire PressureWire reading of Pd guidewire guidewire for pressure additional information Failure in PW unit Test PW IN Test of PW IN Contact St. Jude according to passed without Medical Testing PW IN failure (page 70) The PressureWire Connections of the Properly Correct the guidewire not proximal connected failing correctly connector and PW connection connected. E.g., interface unit connector not dry, connector connector not fully inserted or connector damaged

Table 29. Distal pressure signal on QUANTIEN™ measurement system when acquired via wireless PressureWire™ guidewire

Erroneous Possible cause Check Normal function Corrective action function Connection of Defective LED on the LED lights up Use another wireless PressureWire wireless when the wireless wireless PressureWire™ guidewire PressureWire PressureWire PressureWire guidewire fails guidewire guidewire guidewire switched on

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Table 29. Distal pressure signal on QUANTIEN™ measurement system when acquired via wireless PressureWire™ guidewire

Erroneous Possible cause Check Normal function Corrective action function The wireless N/A The Wireless Switch on at the PressureWire PressureWire appropriate time guidewire is guidewire should switched on too be switched on late after connect within 30 seconds command after connect command The wireless Move the wireless Connection Limit distance PressureWire PressureWire successful from the wireless guidewire is too guidewire closer PressureWire far away to the guidewire to the QUANTIEN™ QUANTIEN measurement measurement system system Failure in PW Test with another Connection Contact St. Jude interface unit wireless successful Medical PressureWire guidewire Movement of the See Preparations N/A Follow the PressureWire for use in the instruction for guidewire causes PressureWire preparations disturbance to the guidewire IFU signal when connecting The PressureWire Position of the The PressureWire Remove the guidewire is PressureWire guidewire is PressureWire inserted in patient guidewire outside of patient guidewire from patient Unable to zero Pd Movement of the See Preparations N/A Follow the pressure PressureWire for use in the instruction for guidewire causes PressureWire preparations disturbance on guidewire IFU the signal when zeroing The PressureWire Position of the The PressureWire Remove the guidewire is PressureWire guidewire is PressureWire inserted in patient guidewire outside of patient guidewire from patient Zeroing value out Zeroing value Zeroing value Re-initialize the of range < 30 mmHg wireless PressureWire guidewire i.e. switch it off and on again

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Table 29. Distal pressure signal on QUANTIEN™ measurement system when acquired via wireless PressureWire™ guidewire

Erroneous Possible cause Check Normal function Corrective action function Signal from the Defective LED on the LED is lit Use another wireless PressureWire wireless wireless PressureWire guidewire PressureWire PressureWire guidewire lost guidewire guidewire The wireless Move the wireless Signal available Limit distance PressureWire PressureWire from the wireless guidewire is too guidewire closer PressureWire far away to the QUANTIEN guidewire to the measurement QUANTIEN system measurement system The wireless LED on the LED is lit Switch on the PressureWire wireless wireless guidewire is PressureWire PressureWire switched off guidewire guidewire Abnormal or Defective See IFU for the N/A N/A absent pressure PressureWire PressureWire reading of Pd guidewire guidewire for pressure additional information. Failure in the Test with another Pressure reading Contact St. Jude PressureWire wireless of Pd pressure Medical interface unit PressureWire successful guidewire

Table 30. ECG signal on QUANTIEN™ measurement system

Erroneous Possible cause Check Normal function Corrective action function Abnormal or Bad contact in Stress the actual The ECG signal Replace the absent ECG signal cable connectors connection will remain broken cable mechanically correct Defective AUX IN Visually check the Strain relief intact, Replace the cable cable no other damage broken cable Defective ECG Conduct a signal ECG signal source Contact signal from HRS performance test OK manufacturer of on the HRS the HRS Internal failure of Check HW status AUX status OK Contact St. Jude AUX part in main of AUX after self Medical unit test at power on of main unit

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Table 30. ECG signal on QUANTIEN™ measurement system

Erroneous Possible cause Check Normal function Corrective action function Wrong type of AUX IN cable HRS listed on the Replace with a AUX IN cable compatibility with actual AUX IN correct AUX IN the present HRS cable cable

Table 31. Pressure signal on the HRS via PressureWire™ OUT

Erroneous Possible cause Check Normal function Corrective action function Unable to zero, or PW OUT not Connection of Properly Correct the failing abnormal or properly monitor cable connected connection absent PW OUT connected to pressure signal HRS input on the HRS Bad contact in Stress the actual The pressure Replace the cable connectors connection signal on the HRS broken cable mechanically will remain correct Wrong type of Monitor cable HRS listed on the Replace with a monitor cable compatibility with actual monitor correct monitor the present HRS cable cable Defective monitor Visually check the Strain relief intact, Replace the cable monitor cable no other damage monitor cable Defective PW Test PW OUT Test of PW OUT Contact St. Jude OUT according to passed without Medical Testing PW Out failure (page 71) Defective HRS Test PW OUT Test of PW OUT Contact input channel according to passed without manufacturer of Testing PW Out failure the HRS (page 71) PW OUT not Configuration of PW OUT Edit and correct configured PW OUT in configured PW OUT correctly System Menu correctly configuration in System Menu

Table 32. Pressure signal on the HRS via AUX OUT

Erroneous Possible cause Check Normal function Corrective action function Abnormal or AUX OUT not Connection of Properly Correct the failing absent pressure properly AUX cable connected connection signal on the HRS connected to HRS input

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Table 32. Pressure signal on the HRS via AUX OUT

Erroneous Possible cause Check Normal function Corrective action function Bad contact in Stress the actual The pressure Replace the cable connectors connection signal on the HRS broken cable mechanically will remain correct AUX OUT cable AUX OUT cable AUX OUT cable is Replace with a not compatible compatibility with compatible with correct AUX OUT with HRS the present HRS HRS cable Defective AUX Visually check the Strain relief intact, Replace the AUX OUT cable monitor cable no other damage OUT cable Defective AUX Test AUX OUT Test of AUX OUT Contact St. Jude OUT according to passed without Medical Testing AUX OUT failure 1 & 2 (page 73) Defective HRS Test AUX OUT Test of AUX OUT Contact input channel according to passed without manufacturer of Testing AUX OUT failure the HRS 1 & 2 (page 73) AUX OUT not Configuration of AUX OUT Edit Room Setup configured AUX OUT in configured and correct AUX correctly Room Setup correctly OUT configuration

Table 33. DICOM worklist function

Erroneous Possible cause Check Normal function Corrective action function No worklist Network error Network cables Cables connected Exchange broken received and components and network network cables components and components functional Error in network Network N/A Correct network configuration configuration in configuration in System menu System menu DICOM host error Status of DICOM DICOM host is Correct error in host functional DICOM host DICOM worklist Run verify Verify successful Correct DICOM configured function in worklist incorrectly DICOM Worklist configuration setup in System menu

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Table 33. DICOM worklist function

Erroneous Possible cause Check Normal function Corrective action function Patient not found Patient not Check that Patient is Correct in worklist registered in patient is registered in registration In DICOM host registered in DICOM host DICOM host DICOM host Patient list filter Worklist query Worklist query is Correct worklist incorrect set up to include query desired patient Too many N/A N/A Apply worklist patients in query filter worklist

Table 34. Export function

Erroneous Possible cause Check Normal function Corrective action function Network path Network error Network cables Cables connected Exchange broken export fail and components and network network cables components and components functional Error in network Network N/A Correct network configuration configuration in configuration System menu Error in network Network path N/A Correct network path system menu path (Export) File server error Status of file File server is Correct error in server functional file server USB memory No USB stick USB memory USB memory Insert USB export fail inserted stick stick fully inserted memory stick Error in USB Test with another USB export Replace faulty memory stick USB memory successful USB memory stick stick USB memory Available space N/A Remove files from stick full on USB memory USB memory stick stick or replace with another USB memory stick DICOM archive Network error Network cables Cables connected Exchange broken export fail and components and network network cables components and components functional

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Table 34. Export function

Erroneous Possible cause Check Normal function Corrective action function Error in network Network N/A Correct network configuration configuration in configuration in System menu System menu DICOM export Run verify Verify successful Correct DICOM configured function in Export incorrectly DICOM Export configuration setup in System menu No export at end Auto export not Auto export N/A Correct auto of recording configured configuration in export system menu configuration (Export) Not possible to Exported file Compatibility N/A Set flag for export open exported format not mode setting in in compatibility files in RadiView compatible with System Menu mode software all versions of (Export) RadiView software

Table 35. External display function

Erroneous Possible cause Check Normal function Corrective action function Disturbances or Video OUT (DVI-I) Connection of DVI QUANTIEN Correct the failing no QUANTIEN™ not properly cable. Stress the display viewed on connection or display viewed on connected to actual connection external monitor replace broken external monitor external monitor mechanically cable input or bad contact in cable connectors Wrong cable Compatibility of N/A Replace with a cables and correct cable adapters and/or adapter according to Specifications Interfaces (page 75) Defective cable Visually check the Strain relief intact, Replace the cable monitor cable no other damage Defective DVI-I Test with another QUANTIEN Contact St. Jude port external monitor display viewed on Medical external monitor

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Table 35. External display function

Erroneous Possible cause Check Normal function Corrective action function Defective external Test with another QUANTIEN Replace the monitor external monitor display viewed on external monitor external monitor External monitor Monitor input N/A Replace the not compatible supports signal external monitor with DVI-I signal properties from the according to QUANTIEN Specifications measurement Interfaces (page system 75).

Table 36. Other functions

Erroneous Possible cause Check Normal function Corrective action function Equalize fail Signal error or not Status of Pa and Pa and Pd zeroed Correct errors zeroed Pd or Pa Pd and functional and/or perform zeroing of Pa and Pd Too large Difference Difference Reposition AO difference between average between average transducer and between Pa and of Pa and Pd of Pa and Pd is perform a re- Pd less than zeroing of Pa 30 mmHg Re-zeroing of Pd N/A N/A Re-initialize the has been wireless performed when PressureWire using the wireless guidewire by PressureWire™ turning it off and guidewire then on again Recording ends Recording time Max recording N/A Set appropriate without being limited in setup length in System max recording stopped by user menu (Other) length Memory full Storage space in Storage space is Free-up storage Archive available space Maintenance Remote Control Battery Tools needed: . Phillips screwdriver . New batteries, 2 x AAA (LR03, 1.5V)

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To change batteries proceed as follows: 1. Remove the screws at the back of the remote control. 2. Open the case and remove the plastic holder and remove the batteries. CAUTION: Be careful with the circuit board.

3. Replace the batteries with new ones. Make sure the polarity is correct. Polarity markings are located at the bottom of the casing. CAUTION: Do not reverse the poles. Replace the plastic holder and close the case. Secure it with the screw. System Backup Battery The internal system backup battery is recharged by leaving the QUANTIEN™ measurement system turned on. The battery is not intended to be replaced. Disposal NOTE: To avoid environmental damage and/or personal injury, handling and disposal of batteries and electronic equipment shall be done in accordance with applicable local, state and federal laws and regulations. Cleaning CAUTION: Do not immerse in liquid: Do not use the QUANTIEN™ measurement system if it has been immersed in liquid.

1. Turn OFF the unit and disconnect the mains power cable. 2. After each patient, clean the exterior with a moist tissue, using regular cleaning agents, or if necessary, alcohol, and wipe dry.

3. Reconnect the main power cable. 4. Press ON/OFF switch to ON. WARNING: . Make sure that every part of the unit is dry before reconnecting to the power supply. . Do not use the QUANTIEN measurement system if liquid is suspected to have penetrated the enclosure or the power supply unit. This can cause the user or patient to be exposed to electric shock. Contact St. Jude Medical representatives or technical support for further instructions. Preventative Maintenance Schedule It is recommended that the scheduled preventative maintenance of the QUANTIEN™ measurement system should be performed with an interval not exceeding 12 months. The list below shows the operations needed to ensure the electrical safety and measurement accuracy of the QUANTIEN measurement system. These operations are preferably performed in the order according to the list below. Instructions for performing these operations are found in the instructions in the remainder of this chapter. The measurements should always be carried out by a qualified technician. Ageing of cabling and multi-use pressure transducers can affect performance of measurements. It

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is recommended to check measurement accuracy together with transducer at regular intervals and if suspicious measurements are noted.

Table 37. Preventative Maintenance Table

1 Leakage current measurement Ensure that the components related to electrical safety of QUANTIEN™ measurement system are within their specifications. 2 Testing the PW IN Ensure that the PW IN is functioning properly and has measurement accuracy in accordance with the specification. 3 Testing the PW OUT Ensure that the PW OUT is functioning properly and has measurement accuracy in accordance with the specification. Leakage Current Measurement Tools needed: . Service kit . An adequate instrument for leakage current measurements according to IEC 60601-1 . Service report form, can be downloaded from sjmprofessional.com Preparation: Connect the leakage current adapters to their respective connector on the QUANTIEN™ measurement system. Turn on the QUANTIEN measurement system before starting this control. To perform leakage current measurements proceed as follows: 1. Connect the applicable leakage current adapters to the leakage current instrument for each test that will be performed. The figure below depicts which isolations are tested.

2. Perform the leakage current measurements listed in the table below. Note the leakage current reading in the Service report form.

3. Check that there is no major deviation in the readings compared to previous measurements and that the readings are within the limits in the table below.

Figure 22. Simplified Isolation Diagram for Leakage Current Test

1. Mains 2. Metal accessible parts 3. PW IN (CF applied part) 4. PW OUT (CF applied part)

An additional screw is included in the service kit to easier access the metal accessible parts by

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fastening it into one of the screw holes on the DVI port. NOTE: Do not try to connect to metal accessible parts by clamping on to the metal surface of the heat sink, it is anodized.

Table 38. Leakage current measurements and limits

Measurement Port (Condition) Upper limit (µA)5 Enclosure leakage current Enclosure (NC) 100 Enclosure leakage current Enclosure (NCRM) 100 Enclosure leakage current Enclosure (OS) 500 Enclosure leakage current Enclosure (OSRM) 500 Patient leakage current PW IN (NC) 10 Patient leakage current PW IN (NCRM) 10 Patient leakage current PW IN (OS) 50 Patient leakage current PW IN (OSRM) 50 Patient leakage current PW OUT (NC) 10 Patient leakage current PW OUT (NCRM) 10 Patient leakage current PW OUT (OS) 50 Patient leakage current PW OUT (OSRM) 50 Mains on applied part PW IN (MA) 50 Mains on applied part PW IN (MARM) 50 Mains on applied part PW OUT (MA) 50 Mains on applied part PW OUT (MARM) 50

NC= Normal Condition NCRM= Normal Condition, Reversed Mains OS= Open mains Source OSRM= Open mains Source, Reversed Mains MA= Mains on Applied Part MARM= Mains on Applied Part, Reversed Mains Testing PW IN Tools needed . PW control probe . Service report form, can be downloaded from sjmprofessional.com Preparation . Switch on QUANTIEN™ measurement system at least 10 minutes before starting this test. To test the PressureWire™ IN, proceed as follows: 1. Restart QUANTIEN measurement system by switching the main switch OFF. Wait for 5 seconds and switch ON again. Verify that passed self-test is indicated.

2. Select the applicable room.

5 Upper limit according to IEC 60601-1.

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3. Select patient, for example, default patient. 4. Connect the green PW control probe to QUANTIEN PW IN. 5. Check that zeroing of Pd is successful and that 0 mmHg is displayed as Pd numerical value and curve. In case the zeroing results in an unstable zero or non-zero value, a second attempt may be necessary.

6. Press the buttons on the PW control probe according to the table below. Take a reading after the average Pd value has been stabilized, which can take approximately 5 – 10 sec. Check the reading against the stated limits and note the results in the service report.

7. Disconnect the PW control probe from QUANTIEN measurement system. 8. If errors are found, please contact St. Jude Medical.

Table 39. Upper and lower limits of PW IN readings

PW P (mmHg) Lower limit (mmHg) Upper limit (mmHg) -25 (Black button) -27 -23 0 -1 1 295 (Red button) 293 297

Testing PW OUT and Associated Monitor Channel Tools needed . Monitor cable for PW OUT . HRS . Service report form, can be downloaded from sjmprofessional.com Preparation . Switch on QUANTIEN™ measurement system at least 10 minutes before starting this test. . Connect the monitor cable from PW OUT to the associated Pd input channel on the HRS. To test the PW OUT, proceed as follows: 1. Restart QUANTIEN measurement system by switching OFF the main switch. Wait for 5 seconds and switch ON again. Verify that passed self-test is indicated.

2. Select the applicable room. 3. Enter setup menu/window. 4. Select "System". 5. Select "Other". 6. Select "PW Reference Out". 7. Set 0 mmHg as output signal on QUANTIEN measurement system. 8. Zero the associated Pd channel on the HRS. 9. Set 100 mmHg as the output signal on QUANTIEN measurement system. 10. Read the Pd value on the associated Pd channel on the HRS including the mean value. Record the mean value in the service report and check that it is between 98 and

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102 mmHg.

11. Set Pd as the output signal on QUANTIEN measurement system. NOTE: Limits for HRS readings do not include tolerances for possible deviations in the HRS calibration. Therefore, if any failing measurement is observed the HRS input channel should be checked; see the HRS Service Manual (or equivalent). Testing AUX IN 1 and Associated Monitor Channel Tools needed . AUX IN 1 cable . HRS . Service report form, can be downloaded from sjmprofessional.com Preparation . Switch on QUANTIEN™ measurement system at least 10 minutes before starting this test. . Connect the AUX IN 1 cable from the HRS to AUX IN 1. To test the AUX IN 1, proceed as follows: 1. Restart QUANTIEN™ measurement system by switching the main switch OFF. Wait for 5 seconds and switch ON again. Verify that passed self-test is indicated.

2. Select the applicable room and check that the room is configured for use of AUX IN 1 as AO source.

3. Select patient, for example, default patient. 4. Apply 0 mmHg signal from the HRS, e.g., by applying 0 mmHg pressure from a pressure simulator to the HRS and perform a zeroing in the HRS.

5. Perform a zeroing of Pa in QUANTIEN measurement system. 6. Check that zeroing of Pa is successful and that 0 mmHg is displayed as Pa numerical value and curve. In case the zeroing results in an unstable zero or non-zero value, a second attempt may be necessary.

7. Apply reference a signal from the HRS according to the limits in the table below, or by applying pressure from a pressure simulator to the HRS. Take a reading after average Pa value has been stabilized, which can take approximately 5 – 10 sec. Check the reading against the stated limits and note the results in the service report.

8. If errors are found, perform a new calibration as described in Measure FFR or RFR (page 17).

Table 40. Test limits for AUX IN 1 testing

Pa (mmHg) Limit (mmHg) Low (-25 to -10 mmHg) ±1% Zero (0 mmHg) ±1 mmHg High (200-300 mmHg) ±1% NOTE: The above limits do not include tolerances for possible deviations in the HRS outputs. Therefore, if any failing measurement is observed the HRS output channel should be checked; see the HRS Service Manual (or equivalent).

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Testing AUX IN 2 and Associated Monitor Channel Tools needed . AUX IN 2 cable . HRS . Service report form, can be downloaded from sjmprofessional.com Preparation . Switch on QUANTIEN™ measurement system at least 10 minutes before starting this test. . Connect the AUX IN 2 cable from the HRS to AUX IN 2. To test the AUX IN 2, proceed as follows: 1. Restart QUANTIEN measurement system by switching the main switch OFF. Wait for 5 seconds and switch ON again. Verify that passed self-test is indicated.

2. Select the applicable room and check that the room is configured for use of ECG via AUX IN2.

3. Select patient, e.g., default patient. 4. Apply an ECG signal from the HRS, e.g., by using a patient simulator with the HRS. 5. Check that the signal displayed in QUANTIEN measurement system corresponds with the signal in the HRS. Possibly adjust the ECG display scale to make an assessment of the amplitude. Note the result of the test in the service report. Testing AUX OUT 1 & 2 and Associated Monitor Channel Tools needed . AUX OUT cable . A measuring device, like a multimeter. . Service report form, can be downloaded from sjmprofessional.com Preparation . Switch on QUANTIEN™ measurement system at least 10 minutes before starting this test. . Connect the AUX OUT cable from AUX OUT 1 to a measuring device. To test the AUX OUT, proceed as follows: 1. Restart QUANTIEN measurement system by switching the main switch OFF. Wait for 5 seconds and switch ON again. Verify that passed self-test is indicated.

2. Select to edit the applicable room. 3. Select "AUX". 4. Select "OUT 1". 5. Select "Reference". 6. Set 0.0 V as the output signal on QUANTIEN measurement system. 7. Read the value on the measuring device. If necessary convert the reading value to the corresponding input voltage. Record the converted value in the service report and check that it is between –50mV and +50mV.

8. Set 1.0 V as the output signal on QUANTIEN measurement system. 9. Read the value on the measuring device. If necessary convert the reading value to the

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corresponding input voltage. Record the converted value in the service report. Check the value, subtracted with the value read for 0.0 V reference signal, is between 0.95 and 1.05 V. 10. Set "Off" as the output reference signal on QUANTIEN measurement system. 11. Connect the AUX OUT cable from AUX OUT 2 to a measuring device. 12. Select "OUT 1". 13. Select "AUX". 14. Select "OUT 2". 15. Repeat steps 5 to 9. NOTE: Limits for readings do not include tolerances for possible deviations in the measuring device. Therefore, if any failing measurement is observed, the measuring device should be checked. Test Probes Introduction The PW control probe is a tool for accuracy control of the PressureWire™ input on the QUANTIEN™ main unit. The green PW control probe simulates a PressureWire™ sensor. Environmental Conditions

Table 41. Operating Conditions

Operating, temperature: 15°C to 30°C (59°F to 86°F) max 1°C temperature change during calibration control. Operating, relative humidity: 30-75% Transport and storage, temperature: -40°C to + 70°C Transport and storage, relative 10% to 100% humidity: Cleaning: Clean the control probes with a moist tissue, using a mild detergent. Do not use alcohol-based solutions.

Table 42. Specifications PW Control Probe

Pressure levels -25 mmHg (Black button) 0 mmHg (No button) 295 mmHg (Red button) Accuracy: <0.33 mmHg When using the control probe for accuracy control, the probe must be at the normal temperature for at least 30 minutes before use. The PW control probe has been designed with only passive components and molded plastic in order to achieve maximum robustness. Therefore, the control probe does not need to be calibrated. If any control point measurement fails during regular maintenance, please return the QUANTIEN measurement system together with the control probe used.

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Leakage Adapters Leakage adapters to test patient connections, PW IN/OUT, are included in service kit. The leakage adapters are made for easy connection between the QUANTIEN™ measurement system and external equipment during measurement of leakage currents. The input leakage adapters contain resistors protecting the sensitive components inside the QUANTIEN measurement system during the leakage measurement. Service or Repair Preventative maintenance can be performed by a qualified hospital technician; however, service or repair of the QUANTIEN™ measurement system must only be performed by personnel authorized by St. Jude Medical. Contact St. Jude Medical if the QUANTIEN measurement system requires service, repair or if there is reason to believe the system's security could be compromised. Technical Specifications Pressure Measurement

Table 43. Pressure Measurement

Pressure range -30 to 300 mmHg Accuracy: PressureWire™ ± 1 mmHg plus ± 1% of reading (over the pressure range guidewire6 -30 to 50 mmHg) ± 3% of reading (over the range 50 to 300 mmHg) AUX IN 1 (AO) ± 1 mmHg or 0.5%, whichever is greater Frequency response 0-25 Hz Resolution ≤ 0.2 mmHg Electrical Specifications

Table 44. Electrical specifications

Mains classification Class II Isolation, See Isolation Diagram (page 78) Operating voltage 100-240 V, 50-60 Hz Rated current 0.2 A (230 VAC), 0.35 A (110 VAC) Rated Power Consumption 20 W Specifications Interfaces PW IN Proprietary PressureWire™ interface Isolation: IEC 60601-1 Type CF Defibrillation protected PW OUT According to ANSI/AAMI BP22:1994 Excitation voltage: 2.4 to 8 Volt DC

6 The accuracy is given for the combination of the QUANTIEN™ measurement system and PressureWire™ systems.

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Isolation: IEC 60601-1 Type CF Defibrillation protected AUX IN 1 (AO) Differential analog input Scale factor: Selectable between 50 mmHg/V and 200 mmHg/V Electrical range: ± 10 V (Depending on selected scale factor the measurement range can be less) Isolation: IEC 60601-1 Basic isolation AUX IN 2 (ECG) Differential analog input Scale factor: 1 mV / V Electrical range: ± 10 V Isolation: IEC 60601-1 Basic isolation AUX OUT 1 & 2 Analog output Signal source: Selectable Pa or Pd. Scale factor: 1 V/100 mmHg Max load: 10 kOhm/100 nF Isolation: IEC 60601-1 Basic isolation USB Version: 2.0, supports Hi-speed communication Connector: Type A, Receptacle Ethernet 10/100 Mbit/s Connector: RJ45 DVI Screen resolution of QUANTIEN™ main unit: 1280x800 Output resolutions (DVI out): Auto Frequency: 60 Hz Connector: DVI-I (Integrated - digital and analog) . Connect with a standard VGA cable and DVI to VGA adapter (analog signal) . Connect with a DVI to VGA cable (analog signal) . Connect with a DVI-D cable (digital signal) . Connect with a DVI to HDMI cable (digital signal) Mains Connector in Power Supply Unit Connector: Standard inlet IEC 320-C8 Wireless Transmission Frequency range: 2.4000-2.4835 GHz (ISM-band) Type: Frequency Hopping Spread Spectrum PressureWire™ wireless guidewire and Wi-Box™ radio transmitter specification see IFU for PressureWire wireless guidewire and Wi-Box™ AO transmitter. Mounting VESA 75x75 mm and 100x100 mm

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Dimensions

Table 45. Dimensions

Height 260 mm (10.2 in) Depth 100 mm (3.9 in) Width 375 mm (14.8 in) Weight 4.8 kg (10.6 lbs) Environmental Conditions

Table 46. Environmental conditions

Operating, temperature 15°C to 35°C (59°F to 95°F) Operating, relative humidity 30% - 75% Operating, ambient 525-795 mmHg (700-1060 mbar) pressure Transport and storage, -20°C to +70°C (-4°F to +158°F) temperature Transport and storage, 10% - 95% relative humidity Transport and storage, 375-795 mmHg (500-1060 mbar) ambient pressure

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Isolation Diagram

Figure 23. Isolation Diagram

1. Certified PSU 2. Main Unit 3. Plastic Enclosures 4. Touch Screen Display 5. Metal Enclosure

Table 47. Isolation Data

Isolation Insulation Type Maximum Working Voltage [V] A 1 MOP 240 VAC B 2 MOOP Uw C 1 MOOP 240 VAC + 12 VDC D 2 MOOP 12 VDC

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Table 47. Isolation Data

Isolation Insulation Type Maximum Working Voltage [V] E1,E2,E3 1 MOPP 240 VAC + 5 VDC E1 2 MOPP 5 VDC F 2 MOOP 5 VDC MOP = Means of Protection MOOP = Means Of Operator Protection MOPP = Means Of Patient Protection File Formats

Table 48. Default spreadsheet file format

Text format: ASCII Data Rate: 100Hz Separation: TAB Data Columns: 8 (Time, Pa, Pa mean, Pd, Pd mean, Pd/Pa, Heart rate, ECG)

Table 49. Units

Time: seconds (decimal point) Pa: mmHg (decimal point) Pa mean: mmHg (decimal point) Pd: mmHg (decimal point) Pd mean: mmHg (decimal point) Pd/Pa: N/A (decimal point) Heart rate: bpm ECG: mV DICOM See DICOM Conformance Statement at sjmprofessional.com Compliance with Regulatory Requirements Compliance with Standards and Directives St. Jude Medical hereby declares that the QUANTIEN™ measurement system is in compliance with the essential requirements and other relevant provisions of the Medical Device Directive (EC Directive 93/42/EEC), RE directive 2014/53/EU Annex II, and Quality System Regulation (US). A copy of the Full Declaration of Conformity can be obtained by contacting the EU Representative. QUANTIEN measurement system electrical safety classifications: . Class II equipment; the type of protection against electric shock.

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. Type CF equipment; the degree of protection against electrical shock as indicated by the following symbol:

. Continuous operation according to the mode of operation. The QUANTIEN measurement system complies with the following standards: . IEC 60068-2-1 . IEC 60068-2-2 . IEC 60068-2-30 . 60601-series Ed. 2, the following: - IEC 60601-1 - IEC 60601-1-1 - EC 60601-1-2 - IEC 60601-1-4 - IEC 60601-1-6 - IEC 60601-2-34 - UL 60601–1 - CAN/CSA C22.2 No.601.1–M90 . 60601-series Ed. 3, the following: - IEC 60601-1 - IEC 60601-1-2 - IEC 60601-1-6 - IEC 60601-1-9 - IEC 60601-2-34 - ANSI/AAMI ES60601-1:2005 - CAN/CSA-C22.2 No.60601-1:08 . IEC 62304 . IEC 62366 . ANSI/AAMI BP 22 . ASTM D4169 . ISO 15223-1 . EN 1041 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The QUANTIEN™ measurement system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment.

Table 50. Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

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Emission Test Complianc Electromagnetic Environment e RF emissions Group 1 The QUANTIEN™ measurement system uses RF energy CISPR 11 only for its internal functioning. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class A CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage Complies The QUANTIEN measurement system is suitable for use fluctuations/flicker in all establishments other than domestic and those emissions directly connected with the public low-voltage power IEC 61000-3-3 supply network that supplies buildings for domestic purposes. aGuidance and Manufacturer’s Declaration - Electromagnetic Immunity The QUANTIEN™ measurement system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment.

Table 51. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 Complianc Electromagnetic Environment - Test Level e Level Guidance Electrostatic discharge ±6 kV contact Complies Floors should be wood, concrete (ESD)7 ±8 kV air or ceramic tile. If floors are IEC 61000-4-2 covered with synthetic material, the relative humidity should be at least 30%. Electrical fast ±2 kV for power supply Complies Mains power quality should be transient/burst lines that of a typical commercial or IEC 61000-4-4 ±1 kV for input/ output hospital environment. lines Surge ±1 kV differential mode Complies Mains power quality should be IEC 61000-4-5 ±2 kV common mode that of a typical commercial or hospital environment. Voltage dips, short <5% UT (>95% dip in Complies Mains power quality should be interruptions and UT) for 0,5 cycle that of a typical commercial or voltage variations to 40% UT (60% dip in hospital environment. If the user power supply input UT) for 5 cycles of the QUANTIEN measurement lines 70% UT (30% dip in system requires continued operation during power mains IEC 61000-4-11 UT) for 25 cycles interruptions, it is recommended <5% UT (>95% dip in that the system be powered from UT) for 5 sec an uninterruptible power supply

7 PressureWire™ guidewire is ESD sensitive and non-compliant with 6kV.

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Table 51. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 Complianc Electromagnetic Environment - Test Level e Level Guidance or battery. Power frequency 3 A/m Complies Power frequency magnetic fields (50/60 Hz) magnetic should be at levels characteristic field of a typical location in a typical commercial or hospital IEC 61000-4-8 environment. Portable and mobile RF communication equipment should be used no closer to any part of the QUANTIEN measurement system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF 3 Vrms 150 kHz 3V d = 1.17 √ P IEC 61000-4-6 to 80 MHz Radiated RF 3 V/m 80 MHz 3 V/m d = 1.17 √ P 80 MHz IEC 61000-4-3 to 2.5 GHz to 800 MHz d = 2.33 √ P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey*, should be less than the compliance level in each frequency range.8 Interference may occur in the vicinity of equipment marked with the following symbol:

8 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 51. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 Complianc Electromagnetic Environment - Test Level e Level Guidance

*Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.

NOTE:

. At 80 MHz and 800 MHz, the higher frequency range applies. . These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

. UT is the a.c. mains voltage prior to application of the test level. Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and QUANTIEN™ System The QUANTIEN™ measurement system is intended for use in the electromagnetic environment where radiated RF disturbances are controlled. The customer or the user of this system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment. Rated Separation Distance to Frequency of Transmitter (m) maximum output power 150 kHz to 80 MHz d = 80 MHz to 800 MHz d 800 MHz to 2.5 GHz d of transmitter 1.17√P = 1.17√P = .233√P (W) 0.01 0.12 0.12 0.23 0.10 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE:

. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

. These guidelines may not apply in all situations. Electromagnetic propagation is

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affected by absorption and reflection from structures, objects and people. Warranty Disclaimer Although the QUANTIEN™ measurement system, hereafter referred to as "product", has been manufactured under carefully controlled conditions, St. Jude Medical (SJM), has no control over the conditions under which the product is used. SJM, therefore disclaims all warranties, both expressed and implied, with respect to the product, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. SJM shall not be liable to any person or entity for any medical expenses or any direct, incidental or consequential damages caused by any use, defect, failure or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort or otherwise. No person has any authority to bind SJM to any representation or warranty with respect to the product. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict with applicable law by court of competent jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Disclaimer of Warranty did not contain the particular part or term held to be invalid. Australian Warranty This warranty is given by St. Jude Medical (SJM). To make inquiries regarding this warranty, use the contact information for either the manufacturer or Australian Sponsor located on the back cover. Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure. The benefits to you given by this warranty are in addition to your other rights and remedies under the Australian Consumer Law. SJM warrants to the buyer that the goods, for a period equal to the validated shelf life of the goods (the "Warranty Period"), shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer's instructions for use and shall be free from defects in materials and workmanship. Unless otherwise obligated by law or mandatory consumer guarantees, under this warranty SJM will, at its option, replace or repair the goods at its factory, if the buyer, at the buyer's expense, returns the goods within the Warranty Period to SJM to the address below and after SJM confirms that the goods are defective. St. Jude Medical Attn: Postmarket Surveillance Return Number One St. Jude Medical Drive St. Paul MN, 55117 USA Tel.: (651) 756-2000 To the maximum extent permitted by law, if a mandatory term is implied by law or a mandatory consumer guarantee applies to the goods, and the goods are not of a kind ordinarily acquired for personal, domestic or household use or consumption, SJM’s liability for the breach of the term or guarantee is limited to, at SJM’s option, either replacement or repair of the goods or payment of

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the costs of replacing or repairing the goods. EXCEPT FOR MANDATORY TERMS IMPLIED BY LAW, MANDATORY CONSUMER GUARANTEES, OR AS EXPRESSLY PROVIDED IN THIS WARRANTY, ST. JUDE MEDICAL DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. See the Terms and Conditions of Sale for further information.

State: Released Date: 2019.03.06 22:30 GMT

State: Released Date: 2019.03.06 22:30 GMT State: Released Date: 2019.03.06 22:30 GMT

St. Jude Medical St. Jude Medical Australia Pty. Limited St. Jude Medical Coordination Center BVBA 17 Orion Road One St. Jude Medical Drive The Corporate Village Lane Cove NSW 2066 St. Paul, MN 55117-9913 USA Da Vincilaan 11 Box F1 Australia +1 855 478 5833 1935 Zaventem +1 651 756 5833 Belgium +32 2 774 68 11

sjm.com

2019-02 ARTEN600064528 A