1
EnSite™ Contact Force Module
INSTRUCTIONS FOR USE
INTERNATIONAL EDITION
Software Version 2.0
© Copyright 2015
St. Jude Medical
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subsidiaries. ST. JUDE MEDICAL and the nine-squares
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Medical, Inc. All Rights Reserved.
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AUSTRALIA
+61 (02) 9936 1200
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2015-12
EnSite™ Contact Force Module Instructions for Use
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Consult Instructions for Use
Caution
Dispose of hardware in accordance with
local law
Keep dry
Do not use if package is damaged
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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
Software Upgrade Kit
For Use With
Software
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Description
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EnSite™ Contact Force Module Instructions for Use
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Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Stability Settings Menu . . . . . . . . . . . . . . . . . . . . . 19
System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
System Connection Diagram . . . . . . . . . . . . . . . . . . . . . . . . 5
AutoMap Settings Menu . . . . . . . . . . . . . . . . . . . . 20
Indications for use. . . . . . . . . . . . . . . . . . . . . . . . . . 5
Ablation Detection Threshold Setting . . . . . . . . . . 21
Important Safety Information . . . . . . . . . . . . . . . . . 5
Preset Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Operator Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Systems. . . . . . . . . . . . . . . . . . . . . 6
TactiSys™ Quartz Unit Setup . . . . . . . . . . . . . . . . . . . . . . . 6
Hardware Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Configure the EnSite™ Contact Force Module. . . . 7
Configure from Inside a Study . . . . . . . . . . . . . . . . . . . . . . 7
Enter the TactiSys™ Quartz Unit Serial Number. . . . . . . . . . 7
Connect to the TactiSys™ Quartz Unit. . . . . . . . . . 9
Connection Icon States . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Connection Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
EnSite™ Contact Force Module User Interface . . 10
Map Display Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
A. Force values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Illustration of forces . . . . . . . . . . . . . . . . . . . . . . . . . 12
Graphical representation . . . . . . . . . . . . . . . . . . . . . . 12
B. LSI™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
C. FTI™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
D. Reset Force-Reset FTI™/LSI™ . . . . . . . . . . . . . . . . . . . 13
E. Graphical Representation of Force. . . . . . . . . . . . . . . . . 13
Metric Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Resize Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Ball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Concentric circles . . . . . . . . . . . . . . . . . . . . . . . . . . 14
F. Blue Arrow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
G. Stability Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Average Contact Force . . . . . . . . . . . . . . . . . . . . . . . 15
Constant Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Stable Contact Force . . . . . . . . . . . . . . . . . . . . . . . . 15
H. EnSite™ Contact Force Module Settings . . . . . . . . . . . . 16
I. Tip Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
J. Information Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
K. Force History Window . . . . . . . . . . . . . . . . . . . . . . . . . 16
L. Indicator of RF Application. . . . . . . . . . . . . . . . . . . . . . 17
M. Force Scale Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
N. Resize arrow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
O. Tick Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
P. Instantaneous Contact Force Waveform . . . . . . . . . . . . . 17
Q. Average Contact Force Waveform . . . . . . . . . . . . . . . . . 17
Display Settings Menu . . . . . . . . . . . . . . . . . . . . . 18
Save a Preset . . . . . . . . . . . . . . . . . . . . . . .
Load a Preset . . . . . . . . . . . . . . . . . . . . . . .
Manage Presets . . . . . . . . . . . . . . . . . . . . .
Rename the Preset and Physician Name
Add notes to the preset . . . . . . . . . . . .
Delete the preset . . . . . . . . . . . . . . . . .
.......
.......
.......
.......
.......
.......
...
...
...
...
...
...
22
23
23
24
24
24
Start an EnSite™ Contact Force Module Procedure
25
To start the procedure: . . . . . . . . . . . . . . . . . . .
Resetting the Force Values to Baseline . . . . . . . .
When to check for baseline contact force . . .
Ablation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ablation phases. . . . . . . . . . . . . . . . . . . . .
How to Reset the FTI™/LSI™ Value . . . . . .
Results of manual reset FTI/LSI: . . . . . . . . .
....
....
....
....
....
....
....
...
...
...
...
...
...
...
25
26
26
26
26
27
27
Replace a Compatible Catheter . . . . . . . . . . . . . . 27
Export the EnSite™ Contact Force Report . . . . . . 27
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EnSite™ Contact Force Module Instructions for Use
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EnSite™ Contact Force Module Instructions for Use
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Introduction
5
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:
Compatible RF
Generator
EnSite™
Cardiac Mapping
System
TactiSys™
Quartz Unit
Compatible
Catheter
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.
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EnSite™ Contact Force Module Instructions for Use
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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.
Ethernet Switch
EnSite™
Cardiac Mapping
System
TactiSys™ Quartz hardware
Serial Number
Ethernet cable
Ethernet Isolators
Ethernet cable to the TactiSys™ Quartz
hardware
Figure 2. Connections from the EnSite™ Cardiac Mapping System Display Workstation
with Ethernet Switch to the TactiSys™ Quartz Unit
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.
EnSite™ Contact Force Module Instructions for Use
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Configure the EnSite™ Contact Force Module
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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.
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NOTE:
Configure the EnSite™ Contact Force Module
EnSite™ Contact Force Module Instructions for Use
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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.
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Connect to the TactiSys™ Quartz Unit
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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:
Table 1. Connection Icon States
State
Icon
Disconnected
Searching for a connection
Connection 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.
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EnSite™ Contact Force Module Instructions for Use
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EnSite™ Contact Force Module User Interface
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.
A
B
C
D
G
I
E
F
H
J
K
N
L
M
O
M
P
Q
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
EnSite™ Contact Force Module Instructions for Use
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Item
EnSite™ Contact Force Module User Interface
11
Description
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:
E
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.
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)
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).
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EnSite™ Contact Force Module User Interface
NOTE:
EnSite™ Contact Force Module Instructions for Use
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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).
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EnSite™ Contact Force Module User Interface
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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:
Item
1
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)
3
2
4
5
6
7
Figure 7. Metric Display during ablation.
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.
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EnSite™ Contact Force Module User Interface
Concentric circles
The following table explains which angle the circles represent:
Then the angle α is ...
If the center of the ball 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
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.
Figure 8. Angle α (alpha)
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.
Figure 9. Angle θ (theta)
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EnSite™ Contact Force Module User Interface
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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).
Figure 10. Example with all Stability Indicators Displaying.
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).
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EnSite™ Contact Force Module User Interface
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.
Indicating primarily
axial force applied.
Indicating primarily
lateral force applied.
Indicating a combination
of axial and lateral force
applied.
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
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EnSite™ Contact Force Module User Interface
17
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.
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Display Settings Menu
Display Settings Menu
■
To access the Display Settings menu, click the Settings
Item
Metrics
button on the toolbar:
Options
(default value
underlined)
Description
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
Selected
FTI™/LSI™ button on the Metrics display (see
“D. Reset Force-Reset FTI™/LSI™” on page 13).
Lateral Force
Display or hide the Lateral force value (see
Figure 5 on page 10).
Selected
Figure 12. Display Settings Menu
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
Selected
Scale Force
Axis
Display or hide the Force History Window (see
Figure 5 on page 10).
Change the scale of the force axis in the Force
History Window (see Figure 5 on page 10).
Scale Time
Axis
Change the scale of the time axis in the Force
History Window (see Figure 5 on page 10).
Color Change
Upper
Threshold
Changes the color of the graphical force
representation (“ball”) and the force scale
depending on the force.
If Color change is selected, indicates the upper
threshold for color change.
Lower
Threshold
If Color change is selected, indicates the lower
threshold for color change.
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.
80g
Range 30g to 150g
15s
Range 10s to 30s
On
Off
50g
Range 30g to 150g
10g
Range 5g to 30g
Average
Instantaneous
Off
EnSite™ Contact Force Module Instructions for Use
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Stability Settings Menu
19
Stability Settings Menu
■
To access the Stability Settings menu, click the Settings
NOTE:
button on the toolbar, then click the Stability tab from the menu:
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
Options
(default value
underlined)
Description
Stability
Indicator
Displays or hides the stability indicators
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
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
Time interval over which the stability of the
force is analyzed
On
Constant
Force
Threshold
Stability
Calculation
Period
On
Off
Off
5g, 7.5g, 10g, 14g,
20g
Off
1g, 2g, 3g, 4g, 5g
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
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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.
Figure 14. AutoMap Settings Menu
Item
Score
Threshold
Description
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%.
■
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.
■
Speed
Limit
Default the SNR Threshold is enabled and is set at 5.0.
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.
■
Enhanced
Noise
Rejection
Default Distance Threshold is enabled but the default value is set to 1.0 mm.
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.
■
Force
(Contact
Force
Range)
Default the Speed Limit is enabled and is set to 10.0 mm/s.
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.
■
SNR
Threshold
Default the Cycle Length Tolerance is enabled and is set to +/- 20 ms.
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.
■
Distance
Threshold
By default the Score Threshold is enabled and is set to 90%.
Default the Contact Force Threshold is not enabled but the default lower threshold is 10 grams and
the default upper threshold is 50 grams.
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.
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A
Ablation Detection Threshold Setting
21
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
NOTE:
■
at the bottom-right of the screen.
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
Item
Ablation
Detection
Threshold
■
Description
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.
Select the desired setting and click the Close button to dismiss the screen.
Options
(default value
underlined)
Low
High
22
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A
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.
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A
Preset Settings
23
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
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A
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
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A
Start an EnSite™ Contact Force Module Procedure
25
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:
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A
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.
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A
NOTE:
Replace a Compatible Catheter
27
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
EnSite™ Contact Force Module Instructions for Use
ARTEN100141622 A