Volcano FFR Option Operators Manual sw ver level 3.3.X Oct 2014

Complies with the Council Directive 93/42/EEC. Volcano system products meet TUV’s safety requirements. Standards tested to: Tmark: IEC 60601-1: 1988+A1+A2 IEC 60601-1-1:2000 IEC 60601-1-4:2000 IEC 60601-2-34:2000 IEC 60601-2-37:2001+A1+A2 IEC 60601-1:2005 IEC 60601-2-37:2007 cTUVus: UL 60601-1:2003 (R4.06) CAN/CSA-C22.2 NO. 601.1-M90 Attention: Read Operator’s Manual and Instructions For Use prior to using this device. Please contact your local Volcano representative for translated versions. This device contains mercury; dispose according to state/local laws. Do not dispose of this device or its components. Improper disposal may be harmful to the environment and human health. Dispose device per local electronic waste regulations. The LoMap device is a TYPE CF EQUIPMENT, DEFIBRILLATION PROOF, the degree of protection against electrical shock as indicated by this symbol.

Manufactured by: Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 USA Phone: 916.638.8008 Phone: 800.228.4728 (USA and Canada) Fax: 916.638.8112 www.volcanocorp.com

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Authorized European Representative: Volcano Europe BVBA/SPRL Excelsiorlaan 41 B-1930 Zaventem, Belgium Phone: +32.2.679.1076 Fax: +32.2.679.1079 © 2013 Volcano Corporation. All rights reserved. No part of this manual may be reproduced in any form without the written permission of Volcano Corporation. Revision Date: May 2013

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Table of Contents WARRANTY ... 6 LIMITED W ARRANTY ... 6

PATENTS AND TRADEMARKS ... 7 PATENTS ... 7 TRADEMARKS ... 7

WARNINGS AND PRECAUTIONS ... 8 FOR USE ONLY BY TRAINED MEDICAL PERSONNEL... 8 READ AND REVIEW MANUAL BEFORE OPERATION ... 8

CONTACT INFORMATION ... 10 OVERVIEW ... 11 DEVICE DESCRIPTION ... 11 INTENDED USE ... 11 CLINICAL APPLICATIONS ... 11 CONTRAINDICATIONS ... 11 POSSIBLE ADVERSE REACTIONS ... 11 INSTALLATION ... 11 DISPLAYING THE SOFTWARE VERSION ... 12 ® ACTIVATION OF THE IFR FEATURE ... 12 W IRES ... 12

PREPARING FOR A CASE ... 13 CONNECTING THE LOMAP DEVICE (IF NECESSARY) ... 13 TURN SYSTEM POWER ON... 13 ENTER PATIENT DATA AND SELECT THE FFR MODE ... 13 VERIFY CONNECTIONS... 14 SETTINGS ... 15 SYSTEM SETTINGS ... 15 ECG GAIN ... 15 ECG SCALE ... 15 ECG TRACE... 15 DICOM MODALITY ... 15 GRADIENT MODE ... 15 DEMO MODE ... 16 LANGUAGE... 16 REGIONAL SETTINGS ... 16 CATH LAB ID ... 17 DRIVE LETTERS ... 18 SHUTDOWN ... 18 RESTART ... 18 PRESSURE SETTINGS ... 18 AORTIC INPUT ... 18 VENOUS INPUT (NOT APPLICABLE TO IFR) ... 19 DISTAL INPUT ... 19 MAP PERIOD ... 19 CARDIAC CYCLE DETECTION (NOT APPLICABLE TO IFR)... 19 CALCULATION MODE (NOT APPLICABLE TO IFR) ... 20 AORTIC PRESSURE CALIBRATION ... 20

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BALANCING THE AORTIC PRESSURE (IF NECESSARY) ... 22

PERFORMING A CASE ... 23 ENTER PATIENT INFORMATION (OPTIONAL) ... 23 PREPARING THE PIM-FFR FOR USE ... 23 CONNECT THE PRESSURE W IRE ... 24 ACQUIRE FFR PRESSURE MEASUREMENTS... 25 RELOCATING THE FFR BOOKMARK ... 30 ACQUIRE IFR PRESSURE MEASUREMENTS ... 31 ANNOTATING RUNS AND SAVING SCREENSHOTS ... 35 SAVING SCREENSHOTS ... 36 SYSTEM CONTROLLER BUTTONS... 37

REVIEWING A RUN ... 38 ENDING A CASE ... 39 ARCHIVING A CASE ... 40 RETRIEVING A CASE ... 43 CLEANING AND DISINFECTING THE FFR OPTION SYSTEM ... 45 VOLCANO-FFR SYSTEM TECHNICAL SPECIFICATIONS ... 46 PRESSURE MEASUREMENT ACCURACY (DISTAL AND AORTIC) ... 46 LOMAP MODEL 809485-001 INSTRUMENT SPECIFICATIONS ... 46 MAINTENANCE ... 46 INSTRUMENT CLASSIFICATION ... 46 POWER REQUIREMENTS ... 47 ACCESSORIES AND REPLACEMENT PARTS ... 47 SAFETY ... 47 ENVIRONMENTAL ... 47 DISPOSAL... 47 INSTRUMENT CLASSIFICATION ... 47

TROUBLESHOOTING ... 48 COMMON ISSUES... 48 NORMALIZATION ... 48 ARTIFACTS LEADING TO INVALID LOCATION OF FFR ... 48 MESSAGE ALERTS ... 50 ARCHIVING MESSAGES ... 53 IFR MESSAGES ... 55 ACCESSORIES AND REPLACEMENT PARTS ... 56

STANDARDS AND REGULATIONS ... 57

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Warranty NOTICE: Manufacturer’s Specifications and Policies Subject to Change. Volcano Corporation reserves the right to make changes in the products described in this manual in order to improve design or performance. Reproduction or distribution of any portion of this manual without the prior written consent of Volcano Corporation is prohibited.

Limited Warranty Subject to the conditions and limitations on liability stated herein, Volcano Corporation (“Volcano”) warrants that the Volcano PIM-FFR (the “System”) as so delivered shall materially conform to Volcano’s then current specifications for the System, for a period of one year from the date of delivery. ANY LIABILITY OF VOLCANO WITH RESPECT TO THE SYSTEM OR THE PERFORMANCE THEREOF UNDER ANY WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY WILL BE LIMITED EXCLUSIVELY TO SYSTEM REPAIR, REPLACEMENT OR, IF REPLACEMENT IS INADEQUATE AS A REMEDY OR, IN THE OPINION OF VOLCANO, IMPRACTICAL, TO REFUND OF THE PRICE PAID FOR THE SYSTEM. EXCEPT FOR THE FOREGOING, THE SYSTEM IS PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF FITNESS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. FURTHER, VOLCANO DOES NOT WARRANT, GUARANTEE, OR MAKE ANY REPRESENTATIONS REGARDING THE USE, OR THE RESULTS OF THE USE, OF THE SYSTEM OR WRITTEN MATERIALS IN TERMS OF CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE. Buyer understands that Volcano is not responsible for and will have no liability for any items or any services provided by any persons other than Volcano. Volcano shall have no liability for delays or failures beyond its reasonable control. Additionally, this warranty does not apply if:  The System is operated in other than a manner prescribed by Volcano Corporation in the Operator’s Manual, and/or supplements.  The System is operated in a manner that is not in conformance with purchase specifications and specifications contained in the Operator’s Manual, and/or supplements.  The System is not maintained in accordance with procedures in the Operator’s Manual, and/or supplements.  The System is repaired, altered, or modified in any way by other than Volcano Corporation authorized personnel, or without Volcano Corporation authorization. Contact Volcano Corporation Field Service for instructions and issuance of a Return Material Authorization if claims under this warranty become necessary and if the System or components of the System are to be returned. The System or components will not be accepted for warranty purposes unless the return has been authorized by Volcano Corporation. System parts or components repaired or replaced under warranty bear the same warranty expiration date as the original equipment. Consumable parts (data disks, batteries, among others) are warranted only against defects in materials and workmanship. System parts purchased outside the original warranty period are warranted for a period of 90 days, subject to all of the restrictions contained in this Limited Warranty. Use of unauthorized replacement parts may void the warranty. In all cases, Volcano Corporation will be the sole judge as to what constitutes warrantable damage.

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Patents and Trademarks Patents This product, and the use thereof, may be covered by one or more of the following U.S. and international patents: 5257629

6049958

6899682

EP 0707453

5271404

6080109

6962567

EP 0750883

5368037

6106476

6976965

EP 0828164

5453575

6110314

7097620

EP 0871043

5590659

6123673

7134994

GB 2246632

5601082

6165128

7215802

GB 2287375

5603327

6200268

7226417

GB 2301892

5715827

6213950

7359554

JP 3188470

5779644

6238347

AU 776527

JP 3194582

5857974

6254542

DE 69213463.8

JP 3344422

5921931

6283920

DE 60038382.2

JP 3619845

5935072

6283921

DE P69516444.9

JP 3732854

5938615

6381350

EP 0596974

JP 3831743

5993393

6618916

EP 0611291

RE 40608

6036650

6663570

EP 0637937

6041662

6776763

EP 0671221

Other U.S. and international patents are pending.

Trademarks Volcano, the Volcano logo, s5i®, iFR®, Smartwire®, PrimeWire®, PrimeWire PRESTIGE®, and PrimeWire Prestige® PLUS are registered trademarks of Volcano Corporation in the United States and other countries. s5™ is a trademark of Volcano Corporation in the United States and other countries. TM

Instant Wave-Free Ratio and other countries.

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is a trademark of Volcano Corporation in the United States

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Warnings and Precautions WARNINGS ARE USED TO INDICATE THE POSSIBILITY OF SEVERE PERSONAL INJURY. FOLLOW THE INSTRUCTION OR PROCEDURE CORRECTLY TO AVOID INJURY TO THE OPERATOR, PATIENT, OR OTHER PERSONNEL. THE WARNINGS ARE IDENTIFIED BY THE EXCLAMATION SYMBOL. CAUTIONS ARE USED TO INDICATE THE POSSIBILITY OF DAMAGE TO THE EQUIPMENT. FOLLOW THE INSTRUCTION OR PROCEDURE CORRECTLY TO AVOID DAMAGE TO THE EQUIPMENT.

For use only by trained medical personnel CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN (OR PROPERLY LICENSED PRACTITIONER)

Read and review manual before operation Carefully read and review the entire Volcano System Operator’s Manuals. Refer to the section “Warnings and Precautions”. Volcano Corporation makes no warranty, representation or condition of any kind, expressed or implied (including any warranty of merchantability, suitability or fitness for a particular purpose) respecting the misuse of the system, software or catheter. Volcano Corporation, assumes no responsibility or liability for incidental or consequential damages which may result from re-use or misuse of the system, software or catheter. NOTE: Please refer to the Volcano system operator’s manuals for detailed information about the operation of the Volcano system. Pay careful attention to all Cautions and Warnings.

WARNING: This device is not intended for use with high frequency electrosurgical units.

WARNING: Unauthorized modification of any Volcano system device may result in hazard or harm such as shock to patient, user, or both.

WARNING: Before connecting to any device, refer to the Volcano system operator’s manuals.

WARNING: This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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CAUTION: This product is not for use with any equipment other than what has been approved by Volcano Corporation. Use of any other equipment will require testing per IEC 60601-1-1. CAUTION: The PIM-FFR is at risk to damage from contrast fluid or saline entering the wire connector port. This may cause irregular or permanent loss of contact with the pressure wire. The PIM-FFR is particularly vulnerable to these liquids when mounted below contrast and fluid bags. These fluid containers may leak during procedures. The following steps should be taken to prevent PIM-FFR damage: ∙ Locate the PIM-FFR away from leaking fluid bags ∙ Hang PIM-FFR on IV pole at same height (or higher), isolated from leaky fluid bags ∙ Protect or cover the PIM-FFR with a Non-Sterile Cover (Model FFRCVR) to prevent fluids from entering the wire connector port, except when the PIM-FFR is distributed with the Fluid Protection Cable. ∙ Ensure fluid bags do not leak during procedures.

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Contact Information United States: Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 USA Phone: 916.638.8008 Phone: 800.228.4728 (USA and Canada) Fax: 916.638.8112 www.volcanocorp.com Authorized European Representative: Volcano Europe BVBA/SPRL Excelsiorlaan 41 B-1930 Zaventem, Belgium Phone: +32.2.679.1076 Fax: +32.2.679.1079

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Overview This manual is intended to provide information specific to the Volcano FFR option for use on the Volcano system. Please refer to Volcano’s system operator’s manual for information regarding the system and its functionality.

Device Description The Volcano-FFR option is a measurement modality for the Volcano system that provides the capability to make fractional flow reserve (FFR) and Instant Wave-Free Ratio™ ® ® (iFR ) measurements. This option consists of an FFR/iFR specific patient interface module (PIM-FFR) which can be connected to the Volcano system. This PIM-FFR is compatible with all Volcano pressure measurement guide wires (purchased separately).

Intended Use The Volcano-FFR option on the Volcano system measures intravascular blood pressure in all blood vessels, including the coronary and peripheral vasculature, during diagnostic and/or interventional procedures. The Volcano FFR option on the Volcano system should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures. NOTE: See the label provided with the Volcano Corporation functional measurement guide wire for specific indications, contraindications, and possible adverse reactions.

Clinical Applications    

Measure intravascular blood pressure Assess the success of interventional procedures with pre- and post-treatment hemodynamic evaluation Provide additional diagnostic information as an adjunct to or in combination with interventional therapies such as balloon angioplasty or atherectomy Measure blood pressure in the coronary and peripheral vasculature

Contraindications Use of the Volcano system is contraindicated wherever tissue or organ damage is a reasonable probability. The Volcano system is not intended for fetal use.

Possible Adverse Reactions The use of the Volcano Corporation’s guide wires (or any percutaneous intravascular catheter) could result in adverse reactions, including, but not limited to: arterial dissection or occlusion; arterial perforation; embolus or spasm; myocardial infarction; serious arrhythmias; abrupt closure of peripheral vessels.

Installation To ensure proper operation and warranty coverage, the Volcano system must be installed and tested by following the Device Installation and Operational Qualification that accompanies each device.

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Displaying the Software Version To display the Software Version, select the Volcano Logo in the top left corner of the screen. A window will display the IVUS/System version and the FFR version. All references in this manual are based on the IVUS/System version number.

Activation of the iFR® Feature The iFR feature must be activated and enabled by a Volcano Representative. In the deactivated state, the iFR tab is not visible on the screen. In the activated and disabled state, the iFR tab is visible on the screen next to the FFR tab, but data cannot be acquired (although existing cases can still be reviewed). In the activated and enabled state, the iFR tab is visible and fully functional.

Wires SmartWire® II

Models 6600, 6600J, 6603, 6603J, 6613, 6613J

PrimeWire®

Models 7900, 7900J, 7903, 7903J, 7913, 7913J

PrimeWire PRESTIGE®

Models 8185, 8185J, 8300, 8300J

PrimeWire Prestige® PLUS

Models 9185, 9185J, 9300, 9300J

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Preparing for a Case Connecting the LoMap Device (If Necessary) The LoMap instrument (model 809485-001) is an aortic transducer low level to high level amplifier. If the cath lab hemodynamic monitoring system does not provide a high level (nominal 1V/100 mmHg) output, then the LoMap device can be used to convert the low level signal (5 µV/V/1 mmHg) from the pressure transducer to a high level signal that the Volcano-FFR system can process. The LoMap device passes through the signals between the low level transducer and the hemodynamic monitoring system. The LoMap’s output signals are only intended for connection to the system’s high level input. The input signals are only intended to connect to certain hemodynamic systems and aortic transducers approved by Volcano Corporation, see the LoMap package insert for details. Note: The LED on the LoMap device blinks for 4 seconds on power up to indicate the unit is working. The LED is synchronous to a 100 mmHg square wave on the High Level BNC output to test the connection to the system. The LED remains on after the power up test is complete. Note: Prior to initial use, the aortic pressure signal on the Volcano-FFR system should be calibrated with the LoMap device connected to a pressure transducer to ensure accuracy of the measurement. See the Aortic Pressure Calibration section of this manual.

Installation: The Volcano LoMap device should only be installed by a qualified

Volcano representative. In the event the system needs to be relocated or modified, please contact Volcano Technical Support.

To ensure proper operation and warranty coverage, the LoMap instrument must be installed and tested by following the Device Installation and Operational Qualification that accompanies each device.

Turn System Power On Power on the Volcano system if it is not already on. Refer to the Volcano system operator’s manuals for additional instructions on IVUS system setup.

Enter Patient Data and Select the FFR mode When the system is in IVUS mode, enter the Patient Data in the appropriate fields. Then, choose the “Select Mode” button at the bottom left of the screen and choose the FFR modality shown in the figure below. The system will then switch to the FFR interface and initialize the hardware.

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NOTE: The patient information will be transferred from the IVUS modality to the FFR modality. When the patient information is entered on the IVUS side, the user has the capability to switch between FFR/IVUS modes and return to the FFR mode without renormalizing or re-zeroing the wire.

Figure 1.

Select Mode Button

Verify Connections Verify that the FFR patient interface module (PIM-FFR), the aortic input, and the ECG (optional for FFR but required for iFR) are properly connected to the system. An ECG input is required for making iFR measurements. If an iFR measurement is attempted without an ECG connection, an error message will appear on the screen stating “No ECG R-waves detected – and ECG signal is required for iFR analysis”.

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Settings Select the Settings tab then the System tab in the second row. The monitor will display the screen shown below. The information entered on this screen will immediately change and be saved upon entry.

Figure 2.

System Settings Screen

System Settings ECG Gain Adjust the ECG gain by selecting Low or High. A High setting increases the amplitude of the ECG waveform during data acquisition.

ECG Scale Adjust the ECG scale displayed during data acquisition by selecting scale values 1-6. Smaller scale settings will increase the amplitude of the ECG waveform.

ECG Trace Turn on and off the display of the ECG waveform.

DICOM Modality Select the preferred DICOM format by which images will be sent to the picture archiving and communication system (PACS) server.

Gradient Mode Set Gradient Mode to On to allow pressure measurements to be recorded without having to perform normalization. Gradient measurements are useful if there is no aortic and distal pressure to normalize. Gradient Mode will reset to Off when a new patient is started. Gradient Mode is not available with iFR.

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Demo Mode Select the Demo Mode key or the arrow next to it to toggle between Off and Pressure. The demo mode allows the user to view artificial data for demonstration or educational purposes when not operating the Volcano-FFR system with a patient or viewing a recalled study file. The chart background and system status stripe on the bottom of the screen will display the “Demo Mode On” message when this feature is enabled. When starting a demo study (after going Live), the first time normalization process requires that there be at least five cardiac cycles in the display buffer before the Normalize button can be selected. The Demo Mode will start initially showing a time shift between the Pa and Pd waveforms, which will be corrected by the normalization process. The misalignment can be recreated by exiting and reentering Demo Mode.

Language The Volcano-FFR system offers a choice of thirteen languages: Dansk (Danish), Nederlands (Dutch), English, Suomi (Finish), Français (French ), Deutsch (German), Magyar (Hungarian), Italiano (Italian), Norsk (Norse), Polski (Polish), Português (Portuguese), Español (Spanish), and Svenska (Swedish). When the button in the Language box is selected, the screen shown in the figure below will be displayed. Scroll through the list to select the desired language option, then press Select. Each time the language is changed, the Volcano-FFR system displays the message “Please wait during translation.” NOTE: The message will be in the same language that is selected.

Figure 3.

Select Language Screen

Regional Settings When Regional Settings is selected, the screen shown below is displayed. The list displays the date, time, and numbering conventions for each region’s style. To change the setting, select the desired format and press OK.

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Figure 4.

Regional Settings Screen

Cath Lab ID Because several cath labs may share the Volcano-FFR system and because each of those labs may connect different equipment to the Volcano-FFR system inputs, the system software allows each lab to have a specific configuration. The first time the Volcano-FFR system is used in the catheterization laboratory with aortic input from the physio monitor, it is important to check that the physio monitor aortic output conforms to industry standards. When the physio monitor is zeroed, the Volcano-FFR system aortic pressure (Pa) should read zero and when the physio monitor is set to output 100 mmHg, the Volcano-FFR system Pa should read 100 mmHg. If both of these conditions are true, then the physio monitor is appropriately calibrated. Otherwise, the Volcano-FFR system must be calibrated following the Aortic Pressure Calibration procedure with the calibration being stored under an appropriately named Cath Lab ID. If the physio monitor pressure output is not zero on the Volcano-FFR system when zero on the physio monitor, then the Zero Pa button in the Options dialog or in the Settings | Pressure screen must be used to balance the Volcano-FFR system Pa reading at the beginning of each case. To use the Cath Lab ID feature, create a unique identifying name for the cath lab and enter it into the Cath Lab ID data field. Then connect the appropriate inputs, which may include ECG and Aortic. Each of these inputs must be calibrated to the equipment to which it is connected; the local Volcano representative or service engineer will perform the calibration by following the Aortic Pressure Calibration procedure below.Calibration should be repeated whenever there is a change in the hemosystem (hardware or software) that could affect the aortic pressure output or there is a change or maintenance to the Volcano system. This process must be repeated for each cath lab room. Be sure to select the correct Cath Lab ID at the beginning of each procedure to ensure that the specific lab input and output calibrations are recalled. Select the Cath Lab by using the red arrow keys to scroll through the options. NOTE: The current Cath Lab ID is indicated on the Patient tab.

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Drive Letters Before using any particular memory stick device for the first time with the Save Frame feature, use this control to verify the correct drive letter has been specified for the device. The writable portion of most memory sticks will be designated as drive G on the system. However, some devices will utilize drive H. This applies only to models 400-0100.02, 807300-001 and 807400-001. Other systems are not capable of using memory sticks.

Shutdown Selecting the Shutdown button (and answering Yes to the confirming prompt) will shut down and power off the system.

Restart Selecting the Restart button (and answering Yes to the confirming prompt) will cause the system to reboot.

Pressure Settings Select the Settings tab on the bottom of the screen and then select the Pressure tab in the second row. A screen resembling the one shown below will be displayed. (The Gradient default displays Off in Calculation Mode.)

Figure 5.

Pressure Settings Screen

Aortic Input The figure above shows that the source of the aortic pressure signal is from the Physio Monitor (high-level input). The Aortic Input has a Zero Pa button. The user may need to perform a zero adjust if there is an offset between the monitor input and the Volcano-FFR system reading. If necessary, select the Zero Pa button when the physiology monitor is outputting a 0 mmHg signal so that the Volcano-FFR system aortic input also reads 0 mmHg. The Zero Pa button is also available in the Options menu on the FFR screen.

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Venous Input (not applicable to iFR) This preset can be used to adjust the assumed venous pressure by selecting the up or down arrow key next to the box that displays the assumed value. The assumed venous pressure can be set from 0 to 50 mmHg, in 1 mmHg increments. Changing the venous pressure will also change the calculated FFR value. When venous input preset is set with a value greater than zero, the mean venous pressure (Pv) is displayed on the FFR screen. To remove the Pv value on the FFR screen, set the venous input preset value to 0 mmHg. When loading archived cases recorded with system software versions prior to 3.2.1, the Pv may be adjusted after the case is loaded (based on the Pv recorded in the case log). The displayed FFR will not change based on the adjust Pv, but the Pd/Pa display will be updated.

Distal Input The patient interface module performs an auto zero reference of the pressure guide wire when it is attached to the cable connector. The guide wire must be outside the patient’s body when the system performs this auto zero. If an offset occurs prior to inserting the guide wire into the patient’s body, it can be removed by touching the Zero Pd button on the Pressure Setup screen. This sets the pressure display and output voltages to the zero calibration level.

MAP Period The user may select the number of heartbeats over which the system will calculate and display the distal and proximal Mean Arterial Pressures (MAP). Select the Up or Down arrow keys to display the desired number. The range is 1 to 5 beats, with the default being 1 beat. MAP values are not used to calculate iFR. A change to the MAP Period will only change the display of the MAP values in the iFR screen, which are not used to calculate the iFR value.

Cardiac Cycle Detection (not applicable to iFR) The user may select how the Volcano-FFR system will detect the cardiac cycle (R-Wave or Peak Pressure). If R-wave is selected, an ECG input must be connected. Instead of the R-Wave, Peak Pressure can be chosen, which means that the Volcano-FFR system will detect the cardiac cycle as the time from one peak to the next peak on the distal pressure (Pd) waveform. The distal pressure waveform is used to eliminate potential errors in peak detection occurring from aortic pressure channel artifacts such as flushing or manifold valve manipulation. In the absence of a detected cardiac cycle, the software assumes a cardiac period of 2 seconds (30 bpm). If the R-wave option has been selected but an ECG input was not connected, the Volcano-FFR system will base its cardiac-cycle-dependent calculations on a default time window of two seconds since it cannot trigger off of the R-wave. The system will notify the user that the ECG input is not connected with the message “No ECG R-Waves Detected”.

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NOTE: If an ECG input is not used, choose Peak Pressure for detecting the cardiac cycle. NOTE: Since switching the cardiac cycle detection method may in some instances change the length of a cardiac cycle slightly, the pressure mean calculations may in turn be modified. It is recommended that the user only change the cardiac cycle detection method before starting the FFR procedure or before loading an archived case recorded with system software versions prior to version 3.2.1.

Calculation Mode (not applicable to iFR) The Volcano-FFR system is capable of calculating the difference between the aortic and distal pressures and displaying that value on the screen during data acquisition and/or while reviewing a study after the procedure has been completed. The user can choose to display the proximal to distal pressure gradient value on the FFR screen by turning on this setting. The user has the option of displaying either the mean or peak to peak gradient. When this button displays the legend “Mean” the gradient calculated is the difference in the mean proximal to distal pressures, or MAP, values. When the button legend is “Peak” the gradient calculated is the difference between the maximum proximal and maximum distal pressures in a cardiac cycle. The gradient is calculated once each cycle and shown in the FFR screen during the subsequent cycle with a “Pa-Pd(m)” or “Pa-Pd(p)” label. When the gradient display is set to Off, Pa-Pd value is not shown.

Aortic Pressure Calibration Note: Please contact the local Volcano representative for assistance in calibrating the aortic pressure to the Volcano-FFR System. Prior to initial use, the aortic pressure signal on the Volcano-FFR system should be checked to confirm reading accuracy. To calibrate the system, perform the following steps: 1. Select the appropriate Cath Lab ID in the Settings Menu dialog below. Text can be entered in the dialog box if desired.

Figure 6.

Cath Lab ID Button

2. Enter Service Mode under the Service tab (which requires password). 3. Select “Aortic High Level” for Input Calibration.

Figure 7.

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Aortic High Level Button

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