QUANTIEN™ Measurement System

QUANTIEN™ Measurement System Diagnostic Computer

C12787

Instructions for Use

State: Released Date: 2019.03.06 22:30 GMT

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

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.

Pat. http://patents.sjm.com

© 2019 St. Jude Medical, LLC. All Rights Reserved.


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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


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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

Abbreviation

Description

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


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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.


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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.


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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.

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DVI-I output – video display/monitor

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USB port – Memory stick, data export, software upgrade

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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


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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


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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 and cables

Required for wireless configuration. Interface for wireless transmission 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) transducer

Required. Transducer shall comply with the standard for invasive 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


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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)


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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 indicator

Placement: In the top section of the open window, to the left of the 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™ guidewire connection indicator

A signal (beep) will be heard when PressureWire guidewire signal is connected to QUANTIEN™ measurement system

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


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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.


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 − Easy access to network/video

connectors Non-sterile nurse can operate

− Display on cath lab monitor

− Sterile operator limited to remote control – limited functionality

− Limited to wireless PressureWire™ guidewire

Wall − No equipment on bed rail or table surfaces

− Easy access to network/video connectors

− Non-sterile nurse can operate


− Sterile operator limited to remote control – limited functionality

− Limited to wireless PressureWire guidewire

Bedside − Close to operator − Sterile operator can control all

features − Allow use of both wireless and

cable connected PressureWire guidewire


− Instrument on bed rail − Limited access to network/video

connectors

Mobile (mounted on IV-pole)

− One instrument for multiple rooms – cost effective

− Allows use of both wireless and cable connected PressureWire guidewire

− Longer set up time − Floor interference − Limited access to network/video

connectors

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.


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) [91.1%, 95.6%]

92.2% (462/501) [89.5%, 94.4%]

Percent Positive Agreement 91.3% (219/240) [86.9%, 94.5%]

88.8% (213/240) [84.1%, 92.5%]

Percent Negative Agreement 95.8% (250/261) [92.6%, 97.9%]

95.4% (249/261) [92.1%, 97.6%]

PPV 95.2% (219/230) [91.6%, 97.6%]

94.7% (213/225) [90.9%, 97.2%]

NPV 92.3% (250/271) [88.4%, 95.1%]

90.2% (249/276) [86.1%, 93.5%]

Diagnostic Accuracy Outside the Grey Zone 88.5% (246/278) [84.1%, 92.0%]

86.8% (256/295) [82.4%, 90.4%]

Lesions free from Hyperemic Agents 55.5% (278/501) [51.0%, 59.9%]

58.9% (295/501) [54.4%, 63.2%]

Patients free from Hyperemic Agents 50.8% (219/431) [46.0%, 55.6%]

54.3% (234/431) [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

− ECG

− Pressure

− Trend graph − Brightness

− Video output

− Other

− Info

− Network

− DICOM

− Export − Regional

− Security

− Other

− Barometer compensation

− Upgrade/Save Setup changes

− Calibrate screen

− Export log files − Time equalize

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:


2. Select the User from the User screen.

3. Touch the Delete User button.

To promote a user to Site Admin:



3. Touch the Promote User button.

To demote a Site Admin to a user:



3. Touch the Demote User button.

To change a user's password:



3. Touch the Change Password button.

4. Enter the initial password for the User.

To unlock a user:



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


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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.


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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

Type

Current Message Reason Action Cancel OK

E "Failed to connect to DICOM peer"

Request (or query) for DICOM worklist failed, i.e., no response from remote host

Check settings Check network connection Check remote host

N/A Acknowledges message and closes window

I "There were more patients matching the worklist query available. Use a more specific query"

Query to remote host contains more records than will be displayed

Redefine query


W "Patient <Last, First> has studies associated that are write protected, they will not be updated"

When an edited patient has write protected studies

Select Cancel or OK

Discards edits and closes window

Confirms edits and closes window


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Type


W "Patient <Last, First> has several studies associated, mark the ones you wish to delete in the list below"

When trying to delete a patient who has more than one study in the archive

Select Cancel or OK

No delete and close window

Confirm delete and close window

I "Export failed" Export failed Check settings for export jobs. Check network connection Check USB

N/A Confirm

W "Register new patient?" Changing the PressureWire™ guidewire for an active patient

Select Cancel, Yes or No

Continue with the current PressureWire guidewire. Close window

Yes: Switches to Patient Screen No: Changes the PressureWire guidewire but keeps the current patient

W "A patient is registered? Do you wish to proceed anyway?"

Entering demo mode with an active patient

Select Cancel or OK

Cancel operation and close window

Continue to enter demo mode, close window

E "Failed to load recording header. File is missing or corrupt."

Header file is missing or corrupt, e.g. with checksum error.

Contact St. Jude Medical


E "Failed to load recording data. File might be corrupt."

Data file is missing or corrupt, e.g. with checksum error.



E "Failed to load recording data. Unable to locate data file."

Data file is missing or corrupt, e.g. with checksum error.




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Type


E "Network update failed. Failed to save network settings to file system"

Failed to write network settings to the appropriate file. File is missing or corrupt.


N/A Confirm and close window

E "Network update failed. Failed to retrieve network settings."

Failed to read network settings from the appropriate file. File is missing or corrupt.



E "Network update failed. Failed to connect to network with new settings"

Network not available or network settings not correct.

Check network settings Check network connection


I "No response on echo request"

Failed to verify settings for DICOM SCU

Check settings


I "No response on echo request"

Failed to verify settings for DICOM export

Check settings


I "Failed to write image to DICOM peer"

Export to DICOM archive failed

Check settings


I "Could not connect to network path"

Failed to verify settings for network path. Settings incomplete or missing

Check settings for network Check settings for network path Check network connection

N/A Confirm


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Type


I "Failed to access to network path"

Failed to use settings for network path. Settings incomplete or missing or no network connection.

Check settings for network Check settings for network path Check network connection

N/A Confirm

E "Hardware initialization failed. Contact your local St. Jude Medical representative"

One or several of the hardware modules for PW, AO or AUX initialized with error at startup

Select "Override" or turn off system

N/A Continue startup (button text "Override")

E "The application failed to upgrade one or several devices. The instrument will not function until an upgrade process has been completed. Switch the instrument off and on again to retry."

Upgrade failed Turn off the instrument Contact St. Jude Medical

N/A N/A

E "The main application binary has an invalid checksum. It has been damaged or corrupted. Please reinstall the system"

Main Application corrupt

Turn off the instrument Contact St. Jude Medical

N/A N/A

E "System settings was not loaded properly, file is missing or corrupt. All settings have been reverted to default values."

System setting files damaged or missing.


N/A Confirm

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

Type Current Message (on Pa button)

Event Action


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


Event Action

E (Red frame)

(Signal Lost)

No communication with the Wi-Box™ AO transmitter

Turn Wi-Box unit on Remove reason for interruption/breakage of communication Select a room with a working Wi-Box unit

E (Red frame)

(Wi-Box Error)

Faulty signal/data from Wi-Box AO transmitter

Restart Wi-Box unit Restart System Contact St. Jude Medical

E (Red frame)

(Pa Interface Error)

AO USB missing AO USB reports error

Restart System Contact St. Jude Medical

E (Red frame)

(Pa Zero failed)

Pressure transducer not open to air when zeroing Zeroing offset out of range

Prepare for zeroing Zero

Table 21. AO Source — AUX IN


Event Action

E (Red frame)

(Pa Interface Error)

AUX missing AUX reports error


E (Red frame)

(Pa Zero Failed)

Pressure transducer not open to air when zeroing Zeroing offset out of range

Prepare for zeroing Zero

Table 22. PW Source — PressureWire™ Wireless Guidewires

Type Current Message (on Pd button)

Event Action


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Table 22. PW Source — PressureWire™ Wireless Guidewires


Event Action

W (Yellow frame)

(Pd Not Zeroed)

Automatic zeroing after successful mate failed

Ensure the PressureWire™ guidewire is correctly prepared Try to connect again

W (Yellow frame)

The PressureWire transmitter is running low on battery

Replace the PressureWire guidewire

E (Red frame)

(Pd Connect failed)

The system cannot connect to the PressureWire guidewire

Ensure that the PressureWire transmitter is turned on at the appropriate time Ensure that it is not too far away from the system

E (Red frame)

(Pd Signal Lost)

Communication with the PressureWire guidewire broken/interrupted The PressureWire wireless guidewire turned off

Turn the PressureWire guidewire on Remove reason for interruption/breakage of communication

E (Red frame)

(Pd Interface Error)

The PressureWire interface missing The PressureWire interface reports error


E (Red frame)

(Pd Zero Failed)

The PressureWire guidewire not positioned correctly (e.g., inserted in the blood flow) when zeroing

Ensure the PressureWire guidewire is correctly prepared and positioned Try to zero again

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


Event Action


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


Event Action

W (Yellow frame)

(Pd Not Zeroed)

Automatic zeroing after inserting connector failed

Ensure the PressureWire™ cable-connection guidewire is correctly prepared Try to connect again

E (Red frame)

(Pd Sensor Disconnected)

Sensor has been disconnected from the QUANTIEN™ measurement system

Reconnect the sensor

E (Red frame)

(Pd Wire Disconnected)

The actual wire has been disconnected from the proximal cable

Reattach the wire to the proximal cable

E (Red frame)

(Pd Sensor Error)

The PressureWire cable-connection guidewire is reporting error

Replace wire

E (Red frame)

(Pd Interface Error)

Cable connecting the PressureWire interface to the QUANTIEN main unit missing or disconnected

Plug in cable Contact St. Jude Medical

E (Red frame)

(Pd Zero Failed)

The PressureWire cable-connection guidewire not positioned correctly (e.g., inserted in the blood flow)

Ensure the PressureWire cable-connection guidewire is correctly prepared and positioned 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.


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

Table 24. General function

Erroneous function

Possible cause Check Normal function Corrective action

No sign of system functioning

The main switch is not turned ON

The main switch ON Turn the main switch ON

Broken or disconnected power cable

The power cable Properly connected to a powered outlet and power supply unit


Internal failure N/A N/A Contact St. Jude Medical

The system stops during the boot sequence before any text is displayed


The system stops during the boot sequence before HW checks are made


The system stops and indicates HW error in PW

Failure in connection to the PressureWire™ interface unit

Cable connection to the PressureWire interface Unit

Cable without damage and connected correctly


Internal failure in the PressureWire interface unit

N/A N/A Contact St. Jude Medical

The system stops and indicates HW error in AO or AUX


Erroneous date and clock information

Internal system battery depleted

N/A Date and time is saved between sessions

Set date and time. Leave QUANTIEN™ measurement system on for 90h to fully recharge the battery

Date and time is not saved after recharge

Internal system battery malfunction

N/A Date and time is saved between sessions



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Table 25. Remote control function

Erroneous function

Possible cause Check Normal function

Corrective action

No or intermittent functioning of the remote control

Low battery N/A N/A Replace the batteries, see Remote Control Battery (page 67)

Defect remote control unit

Check functioning with another remote control unit

The system responds normally

Replace the remote control unit

Internal failure in main unit

N/A N/A Contact St. Jude Medical

Ambient light interference

Switch off ambient light. Check functioning

The system responds normally

Decrease ambient light intensity or switch to another ambient light source

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

Erroneous function


Wi-Box™ AO transmitter not possible to select for a room

Wi-Box unit not powered on or internal failure in Wi-Box unit

Check LED’s of Wi-Box AO transmitter

Refer to IFU for the Wi-Box AO transmitter


Internal failure of AO part in QUANTIEN™ main unit

Check HW status of AO after-self test at power on of QUANTIEN main unit

AO status OK Contact St. Jude Medical

Unable to zero Pa pressure

Varying pressure Check that AO transducer manifold is opened to air

AO transducer manifold is opened to air

Open AO transducer manifold to air

Too high or too low pressure from AO transducer

Check that AO transducer is placed on correct level

AO transducer is placed level with patient

Reposition AO transducer

Disturbance to Pa pressure signal

Check Pa pressure signal for variations

No variation in Pa pressure signal.

Check according to "Abnormal or 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 function


Abnormal or absent pressure reading of Pa pressure

Bad contact in some of the connectors on transducer, interface or monitor cable

Stress the actual connection mechanically

The pressure reading will remain correct

Replace any broken cables

The Wi-Box AO transmitter not powered on or internal failure in Wi-Box unit

Check LED’s of Wi-Box unit



Internal failure of AO part in the QUANTIEN measurement system

Check HW status of AO after self-test at power on of the QUANTIEN measurement system

AO status OK Contact St. Jude Medical

Transducer not connected properly to the Wi-Box AO transmitter

Connections of monitor cable, interface cable and transducer

Properly connected

Correct the failing connection

Defective transducer or transducer interface cable

Functioning of transducer and transducer interface cable with a HRS

Normal transducer function

Replace the transducer or transducer interface cable

Incompatible transducer

Specification of the transducer


Choose a transducer compatible with the Wi-Box AO transmitter

Wrong type of monitor cable

Monitor cable compatibility with the present HRS

HRS listed for the actual monitor cable

Replace with a correct monitor cable

Defective monitor cable

Visually check the monitor cable

Strain relief intact, no other damage

Replace the monitor cable


58

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

Erroneous function


Unable to zero AUX AO source

Varying pressure signal output from HRS

Refer to IFU for HRS on how to check pressure output signal

Stable pressure signal

Refer to IFU for the HRS on how to correct pressure output signal

Too high or too low pressure signal output from HRS


Pressure signal close to zero


Unable to calibrate AUX AO source

Varying pressure signal output from HRS


Stable pressure signal


Too high or too low pressure signal output from HRS


Pressure signal close to selected calibration level


Mismatch between selected calibration level and applied pressure signal from HRS

Compare selected calibration level and applied pressure signal from HRS

Pressure signal close to selected calibration level

Select correct calibration level

Unable to zero Pa pressure

Varying pressure Check that AO transducer manifold is opened to air

AO transducer manifold is opened to air

Open AO transducer manifold to air

Too high or too low pressure from AO transducer

Check that AO transducer is placed on correct level

AO transducer is placed leveled with patient

Reposition AO transducer

Disturbance to Pa pressure signal

Check Pa pressure signal for variations

No variation in Pa pressure signal

Check according to "Abnormal or absent pressure reading of Pa pressure"

Abnormal or absent pressure reading of Pa pressure

Bad contact in AUX IN cable connectors


The Pa pressure signal will remain correct

Replace the broken cable

Defective AUX IN cable

Visually check the cable




59

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

Erroneous function


Internal failure of AUX part in main unit

Check HW status of AUX after self-test at power on of main unit

AUX status OK Contact St. Jude Medical

Wrong type of AUX IN cable

AUX IN cable compatibility with the present HRS

HRS listed for the actual AUX IN cable

Replace with a correct AUX IN cable

Abnormal pressure signal measured in HRS

Pressure signal in HRS

Normal pressure signal

Refer to IFU for the HRS on how to correct errors in measured pressure signal

Abnormal pressure signal output from HRS

Refer to IFU for the HRS on how to check pressure output signal

Normal pressure signal


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

Erroneous function


Connection of sensor fail or unable to zero Pd pressure

Defective PressureWire™ guidewire

See IFU for the PressureWire guidewire for additional information

N/A N/A

Failure in PW Unit Test PW IN according to Testing PW IN (page 70)

Test of PW IN passed without failure


Movement of the PressureWire guidewire causes disturbance to the signal when connecting or zeroing

See Preparations for use in the PressureWire guidewire IFU

N/A Follow the instructions for preparations

The PressureWire guidewire is inserted in patient

Position of the PressureWire guidewire

The PressureWire guidewire is outside of patient

Extract the PressureWire guidewire from patient


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

Erroneous function


The PressureWire guidewire not correctly connected. E.g., connector not dry, connector not fully inserted or connector damaged

Connections of the proximal connector and the PressureWire interface unit connector

Properly connected


Abnormal or absent pressure reading of Pd pressure

Defective PressureWire guidewire

See IFU for the PressureWire guidewire for additional information

N/A N/A

Failure in PW unit Test PW IN according to Testing PW IN (page 70)

Test of PW IN passed without failure


The PressureWire guidewire not correctly connected. E.g., connector not dry, connector not fully inserted or connector damaged

Connections of the proximal connector and PW interface unit connector

Properly connected


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

Erroneous function


Connection of wireless PressureWire™ guidewire fails


LED on the wireless PressureWire guidewire

LED lights up when the wireless PressureWire guidewire switched on

Use another wireless PressureWire guidewire


61


Erroneous function


The wireless PressureWire guidewire is switched on too late after connect command

N/A The Wireless PressureWire guidewire should be switched on within 30 seconds after connect command

Switch on at the appropriate time

The wireless PressureWire guidewire is too far away

Move the wireless PressureWire guidewire closer to the QUANTIEN™ measurement system

Connection successful

Limit distance from the wireless PressureWire guidewire to the QUANTIEN measurement system

Failure in PW interface unit

Test with another wireless PressureWire guidewire

Connection successful


Movement of the PressureWire guidewire causes disturbance to the signal when connecting


N/A Follow the instruction for preparations




Remove the PressureWire guidewire from patient

Unable to zero Pd pressure

Movement of the PressureWire guidewire causes disturbance on the signal when zeroing


N/A Follow the instruction for preparations




Remove the PressureWire guidewire from patient

Zeroing value out of range

Zeroing value Zeroing value < 30 mmHg

Re-initialize the wireless PressureWire guidewire i.e. switch it off and on again


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Erroneous function


Signal from the wireless PressureWire guidewire lost



LED is lit Use another wireless PressureWire guidewire

The wireless PressureWire guidewire is too far away

Move the wireless PressureWire guidewire closer to the QUANTIEN measurement system

Signal available Limit distance from the wireless PressureWire guidewire to the QUANTIEN measurement system

The wireless PressureWire guidewire is switched off


LED is lit Switch on the wireless PressureWire guidewire

Abnormal or absent pressure reading of Pd pressure


See IFU for the PressureWire guidewire for additional information.

N/A N/A

Failure in the PressureWire interface unit

Test with another wireless PressureWire guidewire

Pressure reading of Pd pressure successful


Table 30. ECG signal on QUANTIEN™ measurement system

Erroneous function


Abnormal or absent ECG signal

Bad contact in cable connectors


The ECG signal will remain correct


Defective AUX IN cable

Visually check the cable



Defective ECG signal from HRS

Conduct a signal performance test on the HRS

ECG signal source OK

Contact manufacturer of the HRS

Internal failure of AUX part in main unit

Check HW status of AUX after self test at power on of main unit

AUX status OK Contact St. Jude Medical


63

Table 30. ECG signal on QUANTIEN™ measurement system

Erroneous function


Wrong type of AUX IN cable

AUX IN cable compatibility with the present HRS

HRS listed on the actual AUX IN cable

Replace with a correct AUX IN cable

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

Erroneous function


Unable to zero, or abnormal or absent PW OUT pressure signal on the HRS

PW OUT not properly connected to HRS input

Connection of monitor cable

Properly connected




The pressure signal on the HRS will remain correct


Wrong type of monitor cable

Monitor cable compatibility with the present HRS

HRS listed on the actual monitor cable

Replace with a correct monitor cable

Defective monitor cable



Replace the monitor cable

Defective PW OUT

Test PW OUT according to Testing PW Out (page 71)

Test of PW OUT passed without failure


Defective HRS input channel

Test PW OUT according to Testing PW Out (page 71)

Test of PW OUT passed without failure


PW OUT not configured correctly

Configuration of PW OUT in System Menu

PW OUT configured correctly

Edit and correct PW OUT configuration in System Menu

Table 32. Pressure signal on the HRS via AUX OUT

Erroneous function


Abnormal or absent pressure signal on the HRS

AUX OUT not properly connected to HRS input

Connection of AUX cable

Properly connected



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Table 32. Pressure signal on the HRS via AUX OUT

Erroneous function




The pressure signal on the HRS will remain correct


AUX OUT cable not compatible with HRS

AUX OUT cable compatibility with the present HRS

AUX OUT cable is compatible with HRS

Replace with a correct AUX OUT cable

Defective AUX OUT cable



Replace the AUX OUT cable

Defective AUX OUT

Test AUX OUT according to Testing AUX OUT 1 & 2 (page 73)

Test of AUX OUT passed without failure


Defective HRS input channel

Test AUX OUT according to Testing AUX OUT 1 & 2 (page 73)

Test of AUX OUT passed without failure


AUX OUT not configured correctly

Configuration of AUX OUT in Room Setup

AUX OUT configured correctly

Edit Room Setup and correct AUX OUT configuration

Table 33. DICOM worklist function

Erroneous function


No worklist received

Network error Network cables and components

Cables connected and network components functional

Exchange broken network cables and components

Error in network configuration

Network configuration in System menu

N/A Correct network configuration in System menu

DICOM host error Status of DICOM host

DICOM host is functional

Correct error in DICOM host

DICOM worklist configured incorrectly

Run verify function in DICOM Worklist setup in System menu

Verify successful Correct DICOM worklist configuration


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Table 33. DICOM worklist function

Erroneous function


Patient not found in worklist

Patient not registered in DICOM host

Check that patient is registered in DICOM host

Patient is registered in DICOM host

Correct registration In DICOM host

Patient list filter incorrect

Worklist query Worklist query is set up to include desired patient

Correct worklist query

Too many patients in worklist

N/A N/A Apply worklist query filter

Table 34. Export function

Erroneous function


Network path export fail






N/A Correct network configuration

Error in network path

Network path system menu (Export)

N/A Correct network path

File server error Status of file server

File server is functional

Correct error in file server

USB memory export fail

No USB stick inserted

USB memory stick

USB memory stick fully inserted

Insert USB memory stick

Error in USB memory stick

Test with another USB memory stick

USB export successful

Replace faulty USB memory stick

USB memory stick full

Available space on USB memory stick

N/A Remove files from USB memory stick or replace with another USB memory stick

DICOM archive export fail





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Table 34. Export function

Erroneous function




N/A Correct network configuration in System menu

DICOM export configured incorrectly

Run verify function in DICOM Export setup in System menu

Verify successful Correct DICOM Export configuration

No export at end of recording

Auto export not configured

Auto export configuration in system menu (Export)

N/A Correct auto export configuration

Not possible to open exported files in RadiView software

Exported file format not compatible with all versions of RadiView software

Compatibility mode setting in System Menu (Export)

N/A Set flag for export in compatibility mode

Table 35. External display function

Erroneous function


Disturbances or no QUANTIEN™ display viewed on external monitor

Video OUT (DVI-I) not properly connected to external monitor input or bad contact in cable connectors

Connection of DVI cable. Stress the actual connection mechanically

QUANTIEN display viewed on external monitor

Correct the failing connection or replace broken cable

Wrong cable Compatibility of cables and adapters according to Specifications Interfaces (page 75)

N/A Replace with a correct cable and/or adapter

Defective cable Visually check the monitor cable


Replace the cable

Defective DVI-I port

Test with another external monitor




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Table 35. External display function

Erroneous function


Defective external monitor

Test with another external monitor


Replace the external monitor

External monitor not compatible with DVI-I signal from the QUANTIEN measurement system

Monitor input supports signal properties according to Specifications Interfaces (page 75).

N/A Replace the external monitor

Table 36. Other functions

Erroneous function


Equalize fail Signal error or not zeroed Pd or Pa

Status of Pa and Pd

Pa and Pd zeroed and functional

Correct errors and/or perform zeroing of Pa and Pd

Too large difference between Pa and Pd

Difference between average of Pa and Pd

Difference between average of Pa and Pd is less than 30 mmHg

Reposition AO transducer and perform a re-zeroing of Pa

Re-zeroing of Pd has been performed when using the wireless PressureWire™ guidewire

N/A N/A Re-initialize the wireless PressureWire guidewire by turning it off and then on again

Recording ends without being stopped by user

Recording time limited in setup

Max recording length in System menu (Other)

N/A Set appropriate max recording length

Memory full Storage space in Archive

Storage space is available

Free-up storage 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


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



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



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



Connect the AUX IN 2 cable from the HRS to AUX IN 2.

To test the AUX IN 2, proceed as follows:


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.



Connect the AUX OUT cable from AUX OUT 1 to a measuring device.

To test the AUX OUT, proceed as follows:


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


74

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 humidity:

10% to 100%

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™ guidewire6

± 1 mmHg plus ± 1% of reading (over the pressure range -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


AUX OUT 1 & 2

Analog output

Signal source: Selectable Pa or Pd.

Scale factor: 1 V/100 mmHg

Max load: 10 kOhm/100 nF


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 pressure

525-795 mmHg (700-1060 mbar)

Transport and storage, temperature

-20°C to +70°C (-4°F to +158°F)

Transport and storage, relative humidity

10% - 95%

Transport and storage, ambient pressure

375-795 mmHg (500-1060 mbar)


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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.


80

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 Compliance

Electromagnetic Environment

RF emissions CISPR 11

Group 1 The QUANTIEN™ measurement system uses RF energy 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 CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies The QUANTIEN measurement system is suitable for use in all establishments other than domestic and those directly connected with the public low-voltage power 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 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic discharge (ESD)7 IEC 61000-4-2

±6 kV contact ±8 kV air

Complies Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/ output lines

Complies Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

Complies Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations to power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

Complies Mains power quality should be that of a typical commercial or hospital environment. If the user of the QUANTIEN measurement system requires continued operation during power mains interruptions, it is recommended that the system be powered from an uninterruptible power supply

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


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Compliance Level


or battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m Complies Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital 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 IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V d = 1.17 √ P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m d = 1.17 √ P 80 MHz 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.


83



Compliance Level


*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 maximum output power of transmitter (W)

Separation Distance to Frequency of Transmitter (m)

150 kHz to 80 MHz d = 1.17√P

80 MHz to 800 MHz d = 1.17√P

800 MHz to 2.5 GHz d = .233√P

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


84

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.


St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117-9913 USA +1 855 478 5833 +1 651 756 5833

St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11

St. Jude Medical Australia Pty. Limited 17 Orion Road Lane Cove NSW 2066 Australia

sjm.com

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QUANTIEN™ Measurement System

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