EnSite Contact Force 2.0 Module - St. Jude Medical/media/manuals/product... · Configure the EnSite™ Contact Force Module EnSite™ Contact Force Module Instructions for Use ARTEN100141622

© Copyright 2015St. Jude Medical

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 services marks of St. Jude Medical, Inc. and its related companies. © 2015 St. Jude Medical, Inc. All Rights Reserved.

1

EnSite™ Contact Force Module INSTRUCTIONS FOR USE

INTERNATIONAL EDITION

Software Version 2.0

ARTEN100141622 A

2015-12

St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN55117-9913 USA+1 855 478 5833+1 651 756 5833sjm.com

St. Jude MedicalCoordination Center BVBAThe Corporate Village Da Vincilaan 11 Box F11935 ZaventemBelgium+32 2 774 68 11

Australian Sponsor:St. Jude Medical Australia Pty Limited17 Orion Rd.,Lane Cove NSW 2066AUSTRALIA+61 (02) 9936 1200

2 EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Symbol Description

Consult Instructions for Use

Caution

Dispose of hardware in accordance with local law

Keep dry

Do not use if package is damaged

Lot Number

Catalog Number

Manufacturer

Date of Manufacture

Package contains 1 item.

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

Software Upgrade Kit

For Use With

Software

Software Upgrade Kit

Authorized representative in the European community

Notified body CE mark

Symbol Description

3

Table of Contents

EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5System Connection Diagram . . . . . . . . . . . . . . . . . . . . . . . . 5

Indications for use. . . . . . . . . . . . . . . . . . . . . . . . . . 5

Important Safety Information . . . . . . . . . . . . . . . . . 5Operator Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Connecting the Systems. . . . . . . . . . . . . . . . . . . . . 6TactiSys™ Quartz Unit Setup . . . . . . . . . . . . . . . . . . . . . . . 6Hardware Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Configure the EnSite™ Contact Force Module. . . . 7Configure from Inside a Study . . . . . . . . . . . . . . . . . . . . . . 7Enter the TactiSys™ Quartz Unit Serial Number. . . . . . . . . . 7

Connect to the TactiSys™ Quartz Unit. . . . . . . . . . 9Connection Icon States . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Connection Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

EnSite™ Contact Force Module User Interface . . 10Map Display Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 10A. Force values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Illustration of forces . . . . . . . . . . . . . . . . . . . . . . . . . 12Graphical representation. . . . . . . . . . . . . . . . . . . . . . 12

B. LSI™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12C. FTI™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12D. Reset Force-Reset FTI™/LSI™ . . . . . . . . . . . . . . . . . . . 13E. Graphical Representation of Force. . . . . . . . . . . . . . . . . 13

Metric Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Resize Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Ball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Concentric circles . . . . . . . . . . . . . . . . . . . . . . . . . . 14

F. Blue Arrow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14G. Stability Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Average Contact Force . . . . . . . . . . . . . . . . . . . . . . . 15Constant Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Stable Contact Force . . . . . . . . . . . . . . . . . . . . . . . . 15

H. EnSite™ Contact Force Module Settings . . . . . . . . . . . . 16I. Tip Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16J. Information Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16K. Force History Window . . . . . . . . . . . . . . . . . . . . . . . . . 16L. Indicator of RF Application. . . . . . . . . . . . . . . . . . . . . . 17M. Force Scale Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17N. Resize arrow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17O. Tick Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17P. Instantaneous Contact Force Waveform . . . . . . . . . . . . . 17Q. Average Contact Force Waveform . . . . . . . . . . . . . . . . . 17

Display Settings Menu . . . . . . . . . . . . . . . . . . . . . 18

Stability Settings Menu . . . . . . . . . . . . . . . . . . . . . 19

AutoMap Settings Menu . . . . . . . . . . . . . . . . . . . . 20

Ablation Detection Threshold Setting . . . . . . . . . . 21

Preset Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Save a Preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Load a Preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Manage Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Rename the Preset and Physician Name . . . . . . . . . . 24Add notes to the preset . . . . . . . . . . . . . . . . . . . . . . 24Delete the preset . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Start an EnSite™ Contact Force Module Procedure 25

To start the procedure: . . . . . . . . . . . . . . . . . . . . . . . . . . 25Resetting the Force Values to Baseline . . . . . . . . . . . . . . . 26

When to check for baseline contact force . . . . . . . . . . 26Ablation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Ablation phases. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26How to Reset the FTI™/LSI™ Value . . . . . . . . . . . . . 27Results of manual reset FTI/LSI: . . . . . . . . . . . . . . . . 27

Replace a Compatible Catheter . . . . . . . . . . . . . . 27

Export the EnSite™ Contact Force Report . . . . . . 27

4 EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

This Page Intentionally Left Blank

Introduction 5EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Introduction

System description

The EnSite™ Contact Force Module is a software entitlement feature within the EnSite™ Cardiac Mapping System, which operates with the TactiSys™ Quartz Unit, compatible catheter, and compatible RF generator. The EnSite™ Contact Force Module’s main feature is to display the contact force of compatible ablation catheters.

NOTE: Refer to the EnSite™ Cardiac Mapping System Instructions for Use, the TactiSys™ Quartz Unit Equipment User Manual, the compatible catheter’s Instructions for Use, and the compatible RF generator’s Instructions for Use for complete operating instructions on those components.

System Connection Diagram

The following illustration shows how the EnSite™ Cardiac Mapping System and the TactiSys™ Quartz Unit are interconnected:

Figure 1. The EnSite™ Cardiac Mapping System and the TactiSys™ Quartz Unit Interconnections

Indications for use

When used with the TactiSys™ Quartz Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

Important Safety Information

WARNING: A Warning indicates that there is a risk of injury to the patient or user.

CAUTION: A Caution refers to a condition that may lead to damage or malfunction of the equipment.

NOTE: A Note provides additional information.

Operator Requirements

The EnSite™ Contact Force Module must be operated by, or under the supervision of, an electrophysiologist trained in the operation of the EnSite™ Contact Force Module and supported by other qualified personnel trained in the field of cardiac electrophysiology (EP). It must be used in conjunction with other equipment required for electrophysiology studies such as suggested by the Heart Rhythm Society1.

TactiSys™ Quartz Unit

CompatibleCatheter

EnSite™ Cardiac Mapping

System

Compatible RF Generator

6

Connecting the Systems


Connecting the Systems

TactiSys™ Quartz Unit Setup

NOTE: Refer to the TactiSys™ Quartz Unit User Manual for instructions on setting up the TactiSys™ Quartz Unit.

Hardware Connections

The EnSite™ Cardiac Mapping System and TactiSys™ Quartz Unit Setup Diagram:

NOTE: The Ethernet switch allows users to use multiple modules that require Ethernet connections in conjunction with the EnSite™ Cardiac Mapping System.

1. Heart Rhythm. 2007 Jun;4(6):816-61. Epub 2007 Apr 30. HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Personnel, Policy, Procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation.Developed in partnership with the European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia Scoiety (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic Surgeons (STS), and the Heart Rhythm Society. Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ.Erratum in Heart Rhythm. 2009 Jan;6(1):148.

Ethernet Isolators

Ethernet cable

Ethernet Switch

Figure 2. Connections from the EnSite™ Cardiac Mapping System Display Workstation with Ethernet Switch to the TactiSys™ Quartz Unit

EnSite™Cardiac Mapping SystemTactiSys™ Quartz hardware

Serial Number

Ethernet cable to the TactiSys™ Quartz hardware

Configure the EnSite™ Contact Force Module 7EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Configure the EnSite™ Contact Force Module

NOTE: These instructions describe how to configure the EnSite™ Contact Force Module to communicate with the TactiSys™ Quartz Unit. If the EnSite™ Contact Force Module has already been configured for use with the TactiSys™ Quartz Unit, you can proceed to “Connect to the TactiSys™ Quartz Unit” on page 9.

Configure from Inside a Study

NOTE: A study must be running in order to configure the TactiSys™ Quartz Unit

1. Begin a study, if one is not currently running.

2. Click the EnSite™ Contact Force Module Connection icon at the bottom-right area of the screen, or right-click on the icon and select Configure, or access the About screen from the Help menu.

3. Click the TactiSys™ Quartz tab, if not already showing.

4. Proceed to “Enter the TactiSys™ Quartz Unit Serial Number” on page 7.

Enter the TactiSys™ Quartz Unit Serial Number

Figure 3. The TactiSys™ Quartz tab.

1. From the TactiSys™ Quartz tab, click the “+” button and enter the serial number of the TactiSys™ Quartz Unit into the Serial Numbers field.

NOTE: The serial number is on the right-rear of the TactiSys™ Quartz Unit (see Figure 2 on page 6).

2. Press Enter.

8

Configure the EnSite™ Contact Force Module


NOTE: You can enter multiple serial numbers if there is more than one TactiSys™ Quartz Unit to connect to. You can store serial numbers and switch to different TactiSys™ Quartz Units, but you can only connect to one Unit at a time.

Click the “+” button to add a serial number, or the “-” button to delete a highlighted serial number from the list.

Connect to the TactiSys™ Quartz Unit 9EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Connect to the TactiSys™ Quartz Unit

1. Click the EnSite™ Contact Force Module Connection icon at the bottom-right area of the screen or add a catheter from the Catheter Catalog (see the EnSite™ Cardiac Mapping System Instructions for Use).

2. The EnSite™ Contact Force Module searches for the TactiSys™ Quartz hardware, displaying a message with the serial number of the Unit it is trying to connect to. The Connection icon is yellow during this time and turns green when the connection is made.

Connection Icon States

The EnSite™ Contact Force Module Connection icon, located in the lower-right corner of the EnSite™ Cardiac Mapping System screen, changes state according to the connection status. When the icon turns green, a connection has been established:

Connection Error

NOTE: If the “Connection not configured” message displays after attempting to establish a connection, the EnSite™ Contact Force Module is not properly configured to communicate with the TactiSys™ Quartz Unit:

Figure 4. “Connection not configured” message

1. Click Yes to configure the EnSite™ Contact Force Module.

2. You will be brought to the TactiSys™ Quartz tab in the About screen. Proceed to “Enter the TactiSys™ Quartz Unit Serial Number” on page 7 and complete the configuration procedure.

Table 1. Connection Icon States

State Icon

Disconnected

Searching for a connection

Connection established

10

EnSite™ Contact Force Module User Interface



Map Display Overview

The EnSite™ Contact Force Module user interface shows the measurements of the contact force sensor in the compatible catheter.

Figure 5. The EnSite™ Contact Force Module User Interface

Item Description

A

Total Force value (average)

NOTE: The TF number represents the average, not instantaneous, force. The ball indicator (E) represents instantaneous force. These two indicators may not always be synchronized.

Lateral component force value

Axial component force value

B

Lesion Index

A

G

BC

JK

M

M

L

E

H

D

N

FI

O

P

Q

EnSite™ Contact Force Module User Interface 11EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

A. Force values

Overview

The force values on the procedure screen show the total force, as well as its lateral and axial components as measured by the catheter. All force values are expressed in grams (g).

C

Force-Time Integral

D The Reset Force and Reset FTI™/LSI™ (during ablation) buttons.

■ Reset FTI™/LSI™ is available during ablation

■ Reset Force is available when ablation is off

NOTE: The button normally displays in a realtime case (this screen sample was captured during a review case). See the Metric Display with button at right.

E Graphical representation of the total force and the localization contact (ball) -- see the above graphic in “D”

NOTE: The TF number represents the average, not instantaneous, force. The ball indicator (E) represents instantaneous force. These two indicators may not always be synchronized.

F Blue Arrow: Determines the 0° reference for the angle θ, which represents the direction of the lateral force on the catheter with respect to its steering plane. The angle value increases in the clockwise direction. See “F. Blue Arrow” on page 14.

G Stability indicator (see “G. Stability Indicator ” on page 15”)

Average Contact Force

Constant Contact

Stable Contact Force

H EnSite™ Contact Force Module Settings Menu Button (Display, Stability, and Preset settings).

I Tip Indicator: Tip lengthens with increased axial force, flares out with increased lateral force.

NOTE: This is not the actual catheter tip -- it is a graphical representation of force and does not indicate location.

J Information field (messages display above and within the Force History Window)

K Force History Window: graph of the force exercised during the preceding 15 seconds (sweep)NOTE: Right-click in the window for a menu with additional formatting options.

L Indicator of RF application (red fill)

M Force scale lines, indicating upper and lower thresholds

N Resize arrow: Click the arrow to resize the Force History Window.

O One-second tick marks.

P Instantaneous Contact Force Waveform (select unfiltered checkbox “P” to display)

Q Average Contact Force Waveform (select filtered checkbox “Q” to display)

Item Description

12



NOTE: The color of the Total Force value changes depending on the color change thresholds selected in the Display Settings menu on page 18 (Upper Threshold and Lower Threshold, and indicated by the Force Scale Lines (M)). If Color Change is turned on (Display Settings Menu, page 18), these items are green between the upper and lower thresholds, and amber outside these thresholds.

Illustration of forces

The following diagram illustrates the method used to calculate and display contact forces on the user interface:

Figure 6. Illustration of Forces

Graphical representation

The total force is displayed as a ball in the graphical force representation as shown in “E. Graphical Representation of Force” on page 13.

B. LSI™

The LSI (Lesion Index) is a diagnostic parameter that provides feedback on the development of an ablation lesion over time. LSI is based on the contact force, RF current, and ablation duration.

The calculation of the LSI is automatically triggered when ablation current is detected.

The LSI field will display a progression of dots for the first six seconds of ablation delivery or after an FTI™/LSI™ reset. After six seconds have elapsed, a numerical value will display.

LSI can be activated or deactivated in the Display LSI/FTI pulldown (see “Display Settings Menu” on page 18).

C. FTI™

The FTI on the procedure screen shows the real-time value of the Force-Time Integral (FTI). The calculation of the FTI is automatically triggered when ablation current is detected, and indicates the value of force integrated over ablation time, expressed in units of gram seconds (gs).

FTI can be activated or deactivated in the Display LSI/FTI pulldown (see “Display Settings Menu” on page 18).


D. Reset Force-Reset FTI™/LSI™

Pressing the “Reset FTI/LSI” button during RF application resets the FTI™ and LSI™ values to zero. When “Reset Force” is pressed, the total force display is reset to zero (see “Resetting the Force Values to Baseline” on page 26).

E. Graphical Representation of Force

Metric Display

The illustration shows the components of graphical force representation:

Resize Control

Click and drag the control (1) to make the inner and outer concentric circles larger or smaller.

Ball

The ball (2) represents the instantaneous force applied on the catheter tip.

NOTE: The ball indicator (2) represents instantaneous force. The TF number represents the average, not instantaneous, force. These two indicators may not always be synchronized.

■ Ball size: The size of the ball represents the total force magnitude.

■ Ball color: The color of the ball changes depending on the color change thresholds selected in the Display Settings menu on page 18 (Upper Threshold and Lower Threshold, and indicated by the Force Scale Lines). If Color Change is turned on (Display Settings Menu, page 18), the ball is green between the upper and lower thresholds, amber above the high threshold, and gray below the lower threshold. These thresholds are defined in the Color Change settings of the “Display Settings Menu” on page 18.

Item Description

1 Resize Control

2 Ball

3 Inner concentric circle

4 Outer concentric circle

5 Blue Arrow

6 Reset FTI/LSI button (available during ablation)

7 Reset Force Button (available when ablation is off)

2

3

46

Figure 7. Metric Display during ablation.

1

5 7

14



Concentric circles

The following table explains which angle the circles represent:

NOTE: The angle α (alpha) approximates the angle between axial catheter direction and cardiac tissue surface based on the cross product of axial and lateral force components (see Figure 8).

F. Blue Arrow

The blue arrow below the graphical force representation determines the 0° reference for the angle θ. The angle value increases in the clockwise direction.

What is the angle θ?

■ The angle θ represents the direction of the lateral force on the catheter with respect to its steering plane (see Figure 9).

Examples:

■ Force applied at an angle of 180° means that the force is on the steering axis and will tend to decrease the steering radius, e.g. increase deflection (deflect).

■ Force applied at an angle of 0° will tend to increase the steering radius, e. g. decrease deflection (straighten).

Determining the angle θ

■ It is possible to estimate the angle θ by looking at the marks on the outer circle. The marks represent steps of 90 degrees.

If the center of the ball is ... Then the angle α is ...

In the center 90 °

On the inner circle 60 °

On the outer circle 0 °

In between two of the above positions A value between the angles indicated by these positions

Figure 8. Angle α (alpha)

Figure 9. Angle θ (theta)


G. Stability Indicator

The stability indicator is an optional feature that summarizes the catheter stability. If activated in Settings, it displays continuously when a compatible catheter is connected.

Three independent parameters assess average force, constant contact and stable force. Each parameter is calculated based on most recent contact force history and can be activated individually or in combination. If an element has not been selected it will not display.

The indicator displays green when user-defined conditions are met and amber when not. The sensitivity of each parameter can be adjusted in Stability Settings Menu (see “Stability Settings Menu” on page 19).

Average Contact Force

The parameter Average Contact Force provides feedback on the trend of total contact force. The parameter will be:

■ Green when the average contact force is above the threshold defined in the “Stability Settings Menu” on page 19.

■ Amber when the contact force is below the aforementioned threshold.

Constant Contact

The parameter Constant Contact provides feedback on the degree of intermittent contact. The parameter will be:

■ Green when the force is generally constant (total force is maintained above the value selected in the “Stability Settings Menu” on page 19), with little or no intermittent contact.

■ Amber when intermittent contact causes longer periods with little or no force.

Stable Contact Force

The parameter Stable Contact Force provides feedback on the degree of contact force variation over time. This parameter will be:

■ Green when force variation (user-defined, in grams) over the prescribed number of seconds (also user-defined) is low (e.g. stable catheter position with or without respiration impact).

■ Amber when contact force variation exceeds the thresholds defined in the “Stability Settings Menu” on page 19 (e.g. catheter loses contact suddenly or there is a significant force variation due to respiration).

Figure 10. Example with all Stability Indicators Displaying.

16



H. EnSite™ Contact Force Module Settings

Access the Metric display settings menus:

■ “Display Settings Menu” on page 18

■ “Stability Settings Menu” on page 19

■ “Preset Settings” on page 22

I. Tip Indicator

Axial and Lateral force indicator: Tip lengthens with increased axial force, flares out with increased lateral force, and forms a cone indicating axial and lateral force being applied.

NOTE: The color of the Tip Indicator changes depending on the color change thresholds selected in the Display Settings menu on page 18 (Upper Threshold and Lower Threshold, and indicated by the Force Scale Lines (M)). If Color Change is turned on (Display Settings Menu, page 18), the Tip Indicator is green between the upper and lower thresholds, amber above the high threshold, and gray below the lower threshold. These thresholds are defined in the Color Change settings of the “Display Settings Menu” on page 18.

Figure 11. Tip Indicator illustrations

J. Information Field

The area above and within the Force History Graph is used to display messages during the use of the EnSite™ Contact Force Module. When the Contact Force History Graph is not displayed, messages display at the bottom of the map display.

K. Force History Window

The Contact Force History window is a graphical representation of the total contact force over the user-defined period. The scale of the force history can be adjusted in the Display Settings menu (see “Display Settings Menu” on page 18).

NOTE: Right-click in the window for a menu with additional formatting options:

Selection Description

Force Wave Display or hide the force wave

Sweep Mode Turn on sweep mode wave display

Narrow Wave Size Narrows the width of the Force History Window

Force Wave Time Duration of the wave display

Indicating primarily axial force applied.

Indicating primarily lateral force applied.

Indicating a combination of axial and lateral force applied.


L. Indicator of RF Application

The application of RF during ablation is detected automatically and is indicated by red fill within the Contact Force History Graph.

The value of FTI™ and/or LSI™ will be calculated during the application of RF (if FTI and/or LSI is selected in the “Display Settings Menu” on page 18).

M. Force Scale Lines

The force scale threshold lines use color to indicate the user-defined range of desired total contact force. The display can be customized in the Display Settings menu’s Upper Threshold and Lower Threshold settings to accommodate patient specific variations that are normally encountered during the procedure (see “Display Settings Menu” on page 18).

By default, the color change is Off and the force scale is gray. If color change is selected ON, the force scale is green inside the threshold lines and amber outside.

N. Resize arrow

The resize arrow allows you to change the height of the Force History Window. Click the arrow to resize.

O. Tick Marks

Tick marks indicating one-second intervals of the force graph sweep.

P. Instantaneous Contact Force Waveform

Displays the Contact Force in real-time (not averaged), and corresponds to the magnitude of the localization contact ball (see item (E) in the Metric Display). Select the indicated unfiltered checkbox “P” to display.

Q. Average Contact Force Waveform

Displays the averaged Contact Force and corresponds to the Total Force value (A) shown in the Metric Display. Select the indicated filtered checkbox “Q” to display.

18

Display Settings Menu


Display Settings Menu

■ To access the Display Settings menu, click the Settings button on the toolbar:

Item Description

Options

(default value

underlined)

Metrics Display or hide the Metrics force information (see “E. Graphical Representation of Force” on page 13).

Selected

Contact Force Display or hide the Total Force value (see Figure 5 on page 10).

Selected

Reset Display or Hide the Reset Force/Reset FTI™/LSI™ button on the Metrics display (see “D. Reset Force-Reset FTI™/LSI™” on page 13).

Selected

Lateral Force Display or hide the Lateral force value (see Figure 5 on page 10).

Selected

Axial Force Display or hide the Axial force value (see Figure 5 on page 10).

Selected

LSI™ Display or hide the Lesion Index value during ablation (see Figure 5 on page 10).

Selected

FTI™ Display or hide the Force-Time Integral value during ablation (see Figure 5 on page 10).

Selected

Wave Display or hide the Force History Window (see Figure 5 on page 10).

Selected

Scale Force Axis

Change the scale of the force axis in the Force History Window (see Figure 5 on page 10).

80g

Range 30g to 150g

Scale Time Axis

Change the scale of the time axis in the Force History Window (see Figure 5 on page 10).

15s

Range 10s to 30s

Color Change Changes the color of the graphical force representation (“ball”) and the force scale depending on the force.

On

Off

Upper Threshold

If Color change is selected, indicates the upper threshold for color change.

50g

Range 30g to 150g

Lower Threshold

If Color change is selected, indicates the lower threshold for color change.

10g

Range 5g to 30g

Tip Indicator Selects an Average or Instantaneous representation of force in the Tip Indicator, or turn the indicator Off.

NOTE: This feature is different from the EnGuide Proximity Indicator and can be used in addition to it. See the EnSite™ Cardiac Mapping System IFU for details.

Average

Instantaneous

Off

Figure 12. Display Settings Menu

Stability Settings Menu 19EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Stability Settings Menu

■ To access the Stability Settings menu, click the Settings button on the toolbar, then click the Stability tab from the menu:

NOTE: When the stability indicator is first switched On in Settings, the operational parameters must be configured before the stability indicator can be used.

WARNING: Do not rely solely on the stability indicator information during ablation.

Item Description

Options

(default value

underlined)

Stability Indicator

Displays or hides the stability indicators On

Off

Average Force Threshold

Minimum average force to be considered as acceptable. Provides feedback on the trend of total contact force. Icon is green when the average contact force is above the threshold, amber when below.

On

Off

5g, 7.5g, 10g, 14g, 20g

Constant Force Threshold

Minimum force to be considered for contact versus no contact. Provides feedback on the degree of intermittent contact. Icon is green when the force is generally constant (total force is maintained above the selected value), amber when intermittent contact causes longer periods with little or no force.

On

Off

1g, 2g, 3g, 4g, 5g

Stability Calculation Period

Time interval over which the stability of the force is analyzed

On

Off

1s, 2s, 3s, 4s, 5s

Stability Force Variability

Provides feedback on the degree of contact force variation over time. Icon is green when force variation (in grams) over the selected number of seconds is low (e.g. stable catheter position with or without respiration impact).

Icon is amber when contact force variation exceeds the defined thresholds (e.g. catheter loses contact suddenly or there is a significant force variation due to respiration).

On

Off

2.5g, 5g, 7.5g, 10g, 15g

Figure 13. Stability Settings Menu

20

AutoMap Settings Menu


AutoMap Settings Menu

■ To access the AutoMap settings menu, click the gear icon next to the Start AutoMap button at the lower-left corner of the screen.

AutoMap Settings define the minimum criteria that must be met for a mapping point to be automatically collected. Select the box next to each criteria you want to use for automatic point collection.

Item Description

Score Threshold

Full or any combination of the 12 Surface Leads. Only collect mapping points if the 12-Lead Surface Morphology is XX% similar or higher compared to the original template beat 12-Lead Surface Morphology. The user has the ability to set the Score Threshold from 0 to 100%.

■ By default the Score Threshold is enabled and is set to 90%.

Cycle Length Tolerance

Only collect mapping points if the intracardiac measured (CS, HIS, other) Cycle Length is within +/- XX ms of original template beat Cycle Length. User has the ability to set the Cycle Length Tolerance from +/- 0 to 150 ms.

■ Default the Cycle Length Tolerance is enabled and is set to +/- 20 ms.

Speed Limit

Only collect mapping points if the mapping catheter is moving less than XX.X mms/s. User has the ability to set the Speed Limit from 0.1 to 75 mm/s.

■ Default the Speed Limit is enabled and is set to 10.0 mm/s.

Distance Threshold

Only collect mapping points if the 3D position of the roving catheter electrode is X.X mm or more from the previously collected mapping point from that electrode. User has the ability to set the Distance Threshold from 0.1 to 10 mm.

■ Default Distance Threshold is enabled but the default value is set to 1.0 mm.

SNR Threshold

Only collect mapping points if the Signal-To-Noise Ratio on the roving catheter signal is X.X or higher. User has the ability to set the SNR Threshold from 1 to 50.

■ Default the SNR Threshold is enabled and is set at 5.0.

Force (Contact Force Range)

This criteria can only be used if the EnSite™ Contact Force Module is installed and the physician is mapping with a TactiCath™ catheter. Only collect mapping points if the Average Contact Force (as measured by a TactiCath™ Contact Force Catheter) is at least X grams and less than Y grams. User has the ability to set the Lower Threshold from 0 to 30 grams. User has the ability to set the Upper Threshold from 30 grams to 150 grams.

■ Default the Contact Force Threshold is not enabled but the default lower threshold is 10 grams and the default upper threshold is 50 grams.

Enhanced Noise Rejection

Only collect mapping points if the roving catheter signal does not have certain types of noise (Signals with saturations, electrode-to-electrode contact, open electrode noise, signals with degraded conditions such as no location or dropped data). Only uncheck for pace mapping. User has the ability to set the Enhanced Noise Reduction on or off.

■ Default the Enhanced Noise Reduction is enabled.

Figure 14. AutoMap Settings Menu

Ablation Detection Threshold Setting 21EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Ablation Detection Threshold Setting

■ To access the Ablation Detection Settings field on the TactiSys™ Hardware Configuration screen, select the About screen from

the Help menu or right-click the Connection icon at the bottom-right of the screen.

NOTE: You can also access this screen from the About selection of the Help menu either inside or outside of a study.

■ The TactiSys™ Quartz tab of the About screen displays:

Figure 15. The TactiSys™ Quartz tab of the About screen

■ Select the desired setting and click the Close button to dismiss the screen.

Item Description

Options

(default value

underlined)

Ablation Detection Threshold

Sets the threshold at which the ablation current is detected. If ablation current is not detected when ablating, select the “Low” value in the drop down menu.

Low

High

22

Preset Settings


Preset Settings

Once you have the Display and Stability settings configured, you can save the configuration in a preset for later use. When you load the preset, the settings are configured as they were saved.

Save a Preset

1. Click the Settings button on the toolbar to access the Display menu.

2. Click the Preset button on the menu and select Save Preset:

■ The Save Preset dialog box displays.

3. Type the name of the preset and click OK.

■ The preset is saved under the name and is available for loading from the Preset button.

Preset Settings 23EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Load a Preset

When you load a preset, the Display, Stability, and System settings are configured as they were saved in the preset. Once you have at least one preset saved, the preset names display when you click the Preset icon.

NOTE: The preset Nominal, which returns the settings to default, has been predefined.

■ Click the preset name you want to load.

■ The settings are configured as saved in the preset.

Manage Presets

1. Click the Settings button on the toolbar to access the Display menu.

2. Click the Preset button on the Display menu.

3. Click Manage Presets.

24

Preset Settings


Rename the Preset and Physician Name

Select the preset, click Rename, and type in the desired text box. The changes are saved when you click Close.

Add notes to the preset

Select the preset and type in the Notes text box. The changes are saved when you click Close.

Delete the preset

Select the preset and click Delete.

Figure 16. Manage Presets Menu

Start an EnSite™ Contact Force Module Procedure 25EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

Start an EnSite™ Contact Force Module Procedure

NOTE: This basic startup procedure enables force measurements and display only. Without using EnSite™ EnSite™ Surface Electrode Kit patches or validation, the EnSite™ Cardiac Mapping System will not display electrograms and the Tip Indicator will not be displayed.

NOTE: To conduct a full cardiac mapping study, follow the procedures in the Setup chapter in the EnSite™ Cardiac Mapping System Instructions for Use.

NOTE: The message “Please reset baseline” is displayed until the reset is performed.

NOTE: If an invalid catheter is connected, one of the following messages can display: “Contact Force Catheter type not compatible” or “Contact Force Catheter is intended for single use only”.

NOTE: If a damaged catheter is connected, one of the following messages can display: “No Contact Force information available. Check catheter optical connection” or “No Contact Force catheter connected. Check catheter connection. Contact SJM Technical Support if problem persists” or “Contact Force catheter memory failure. Check electrical connection. Contact SJM Technical Support”.

WARNING: Baseline drift of the force output may occur during the procedure. Operator should verify baseline integrity periodically during use. To check for baseline drift, position the catheter tip in a free-floating position away from the heart wall. In case of significant baseline drift (e.g. >5 g), a reset to zero should be applied by clicking the Reset Force button on the EnSite™ Contact Force Module screen (when not ablating).

NOTE: The force measurement is for information only and should not replace standard handling precautions.

To start the procedure:

1. Establish a connection with the TactiSys™ Quartz Unit if not already connected (see “Connect to the TactiSys™ Quartz Unit” on page 9).

2. Begin an EnSite™ NavX™ Navigation and Visualization Technology procedure.

NOTE: If not already done, connect a compatible catheter as described in the TactiSys™ Quartz Equipment User Manual.

3. Enable the Wave and the Metrics settings in the Display Settings menu (see “Display Settings Menu” on page 18).

4. Position the catheter in a free-floating (non-contact) position inside the heart to prepare for a manual baseline reset.

WARNING: Make sure that the catheter is in a free-floating (non-contact) position before manually resetting the baseline. Contact can be identified by periodic changes (“bumps”) on the force graph or generally an uneven force graph (see Figure 17).

Figure 17. Catheter in a non-contact position

WARNING: When the catheter is in a free-floating position, the force value will not be around zero if baseline drift has occurred. Resetting to zero while the catheter is in contact may cause differences between the value shown on the screen and the actual force applied to the tissue.

26

Start an EnSite™ Contact Force Module Procedure


NOTE: The baseline cannot be reset during and 3 seconds after an ablation.

5. Click the Reset Force button on the Metric Display:

Figure 18. Reset Force button on the Metric Display

6. After performing a manual Reset Force:

■ The force displayed is reset to zero.

■ The message “Baseline reset applied” displays.

Resetting the Force Values to Baseline

When to check for baseline contact force

Baseline operation should be checked regularly and if necessary reset to zero, especially under the following circumstances:

■ After the first insertion of the catheter into the body.

■ After reinsertion into the patient’s body after retraction through a sheath.

■ When the message “Please check baseline” displays.

Figure 19. “Please check baseline” message.

NOTE: The “Please check baseline” message displays when high forces have been applied onto the force sensor (> 66g lateral or > 200g total force) or when the system has detected a potential baseline drift.

Ablation

Ablation phases

The TactiSys™ Quartz Unit automatically detects RF energy and indicates the initiation of ablation with red fill within the Contact Force History Graph. When ablation energy is detected, the relevant FTI™ or LSI™ for the specific ablation is continuously calculated and displayed.

Replace a Compatible Catheter 27EnSite™ Contact Force Module Instructions for UseARTEN100141622 A

NOTE: The FTI™ or LSI™ information is most relevant when a point-by-point technique is used as the value displayed is normally calculated over the entire duration of RF application. In cases where the user maintains RF application while moving the catheter to an adjacent position, resetting FTI™/LSI™ allows for calculation of a new FTI or LSI with no RF interruption. Resetting FTI/LSI can be used at any time during an RF ablation (e.g. when a new catheter position is reached).

How to Reset the FTI™/LSI™ Value

■ During an ablation, press the Reset FTI/LSI button on the Metric display:

Figure 20. Reset FTI™/LSI™ button on the Metric display

Results of manual reset FTI/LSI:

■ FTI and LSI during ablation are reset to zero.

■ The message "FTI/LSI reset applied." displays.

WARNING: When ablating on the posterior wall, all information available in the electrophysiology laboratory should be taken into consideration by the operator to determine the amount of RF energy delivered in order to avoid esophageal damage. The operator should not rely solely on LSI or FTI parameters during ablation on the posterior wall.

Replace a Compatible Catheter

NOTE: To replace the catheter currently connected to the TactiSys™ Quartz hardware, refer to the TactiSys™ Quartz Hardware User Manual for complete instructions.

Export the EnSite™ Contact Force Report

EnSite Contact Force reports are exported with the study, when you archive a study to CD/DVD, USB device, or network drive. Refer to the Archiving Studies section of the EnSite™ Cardiac Mapping System Instructions for Use.

28

Export the EnSite™ Contact Force Report


Documents

EnSite Contact Force 2.0 Module - St. Jude Medical/media/manuals/product... · Configure the EnSite™ Contact Force Module EnSite™ Contact Force Module Instructions for Use ARTEN100141622