1

EnSite™ AutoMap Module INSTRUCTIONS FOR USE

Software Version 1.0

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ARTEN100151704 Rev. A
2016-10
 EnSite™ AutoMap Module Instructions for Use
2 ARTEN100151704 Rev. A

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EnSite™ AutoMap Module Instructions for Use
ARTEN100151704 Rev. A Introduction 3

Introduction

Module description
The EnSite™ AutoMap Module is a software entitlement feature within the EnSite™ Cardiac Mapping System. The AutoMap Module
automates the point collection process, based on the user-defined settings. As the catheter is moved, points are collected when the user-
defined settings are met.

NOTE: Refer to the EnSite™ Cardiac Mapping System Instructions for Use for complete operating instructions and Regulatory
considerations.

Indications for use

Refer to the EnSite™ Cardiac Mapping System Instructions for Use for Indications for Use.

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™ AutoMap Module must be operated by, or under the supervision of, an electrophysiologist trained in the operation of the
EnSite™ Cardiac Mapping System with the EnSite™ AutoMap 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.

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™ AutoMap Module Instructions for Use
4 EnSite™ AutoMap Module Overview ARTEN100151704 Rev. A

EnSite™ AutoMap Module Overview

Continuous Mapping Features

Figure 1. Mapping Screen

Item Feature Description

1 Start AutoMap/Stop AutoMap button: Click to begin automatic

mapping point collection — click again to stop automatic mapping point
collection.
Stop All button: Stops automatic mapping point collection AND stops
anatomic model point collection. This is relevant when AutoMap is
being used with the OneMap™ feature.
■ The AutoMap control is only available in the Mapping Workflow.
■ The user can also start/stop the AutoMap feature by using shift+F11
key.
2 The software allows users to Display/Hide the AutoMap Settings by
clicking on the gear button.
■ The software allows users to Pin/Unpin the AutoMap Settings menu
by clicking the pin button.
EnSite™ AutoMap Module Instructions for Use
ARTEN100151704 Rev. A EnSite™ AutoMap Module Overview 5

Item Feature Description

3 AutoMap Settings 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.
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 150 grams. User has the
ability to set the Upper Threshold from 0 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.
 EnSite™ AutoMap Module Instructions for Use
6 EnSite™ AutoMap Module Overview ARTEN100151704 Rev. A

Item Feature Description

4 When mapping points are collected a flash occurs at the active roving
catheter, mapping electrodes that met all of the point collection criteria.
■ The flash at electrodes indicators may be disabled by unchecking
the Flash New Points box.

5 Click the Meter icon on the Tool Pallet to access the Meter Displays
menu.
The Point Collection Status defaults to disabled. It can be turned on by
checking the box within the Meter Displays menu.
Once the Point Collection Status is enabled, it can be disabled within
the Meter Displays menu or by right clicking the mouse on top of the
point collection status box and clearing the checkmark.
EnSite™ AutoMap Module Instructions for Use
ARTEN100151704 Rev. A EnSite™ AutoMap Module Overview 7

Item Feature Description

6 Point Collection Status The individual point collection status icons flash red when the
respective user-defined settings are not met. When one or more of
these icons is red, mapping points will not be collected.
In the example to the left, mapping points would not be collected
because the current beat Cycle Length is outside the Cycle Length of
interest, thus the Cycle Length icon is red.
The entire mapping Point Collection Status box flashes white when a
point is collected.
When a particular point collection criteria is not enabled, the point
collection status icon for that criteria will be displayed gray.
NOTE: The Noise Icon includes SNR and Enhanced Noise Rejection if
both are enabled.
NOTE: For Speed Limit, Distance Threshold, and Noise criteria; the
particular criteria must be unmet for all roving electrodes being
collected in order for the icon to turn red. As an example, the SNR
would have to be beneath the threshold for every roving electrode
being collected in order for the icon to turn red.
7 Selected Point Data Box Displays the Score, Cycle Length, Contact Force (if the EnSite™
Contact Force Module is installed and if the physician is using a
TactiCath™ Catheter to map), and LAT for the current beat or the
selected mapping point.
 EnSite™ AutoMap Module Instructions for Use
8 EnSite™ AutoMap Module Overview ARTEN100151704 Rev. A

Item Feature Description

8 Independent Scoring Interval The Independent Scoring Interval defines the portion of the template
mapping point’s 12-lead surface morphology that is used to compare
with the current beat’s 12-lead surface morphology to determine the
Score of correlation between the two.
If the independent scoring interval is not enabled (the checkbox is not
selected), then the 12-lead surface morphology match score will be
determined using the entire portion of the roving activation interval.
Select the checkbox for Show Scoring Interval Lines so that the two,
red Independent Scoring Interval lines are displayed and can be
adjusted to contain the relevant portion of the signal.

9 TurboMap Use the TurboMap speed to play back through a recording at 10x’s
real-time speed. This may be useful for creating a secondary map from
the original mapping dataset.
EnSite™ AutoMap Module Instructions for Use
ARTEN100151704 Rev. A The EnSite™ AutoMap Module Workflow 9

Item Feature Description

10 Sort The EnSite™ AutoMap Module license enables users to additionally

sort mapping points by Surface Lead Morphology Match Score and by
Signal-To-Noise Ratio.

The EnSite™ AutoMap Module Workflow

1. Set up Mapping settings as usual (refer to the EnSite™ Cardiac Mapping System Instructions for Use for information).
2. Manually Freeze/Save the first point.
3. Set up the AutoMap Settings point collection criteria as described above.
4. Click the Start AutoMap button and start collecting mapping points.
5. Click the Stop AutoMap button to stop collecting mapping points.

Score Map

A Score Map is a map type that plots the surface lead morphology match score associated with each mapping point collected compared
to the originally collected template beat surface lead morphology. The physician may want to use this feature during pace mapping
where it may be useful to plot the 90%-100% morphology match scores in the area of interest.

The user may also sort the points list by score from highest score surface
lead morphology match compared to the template beat to lowest score
surface lead morphology match compared to the template beat. When the
user clicks on the mapping point, they will be able to view the current
mapping point surface lead morphology on top of the template beat
surface lead morphology trace. This may be useful to determine which
surface lead(s) are different from the template beat.

It is possible to adjust the map scale to only display the 90-100% matches
on the map.

The Score Map can also be used during automated mapping to allow users
to automatically collect only those points with morphology match scores
that are XX% similar or higher compared to the template beat and
automatically reject those points that are not XX% similar or higher
compared to the original template beat.
 EnSite™ AutoMap Module Instructions for Use
10 Automatic Recorded Segments when the EnSite™ AutoMap Feature is ARTEN100151704 Rev. A

Automatic Recorded Segments when the EnSite™ AutoMap Feature is

Activated

When Start AutoMap is activated, the software automatically records the data from 10 seconds before the EnSite™ AutoMap feature
was activated and continues recording as long as the EnSite™ AutoMap feature is active.

TurboMap

Once original mapping has occurred, the user may change mapping criteria and play back through the original dataset
at TurboMap speed to generate a new map at 10x’s real-time speed. This is called the TurboMap feature. As an
example, if the original mapping time was 10 minutes, the user can generate a second map in only 1 additional
minute. This same concept could be employed for map3, map4, etc. This may be useful if the physician is mapping
Sinus Rhythm and intermittent, multiple PVC or VT morphology beats are occurring. This may also be useful if the
physician is trying to map multiple, distinct Cycle Length atrial tachycardias.

Number of Mapping Points per Map and number of Maps per Study

There is no limit to the number of mapping points that may be collected per map. The number of mapping points in the map is listed
on the screen.

There is no limit to the number of maps that may be collected per study.

Catheters for Use with Automated Mapping with the EnSite™ AutoMap
Module

Automated mapping with the EnSite™ AutoMap Module does not require a specific or special EP catheter. Physicians may take
advantage of automated mapping with the EnSite™ AutoMap Module with conventional EP catheters with any number of electrodes.
Physicians may take advantage of automatically including/excluding mapping points based on average contact force when the
EnSite™ Contact Force Module is installed and when the physician is using a TactiCath™ Contact Force Catheter to map.
EnSite™ AutoMap Module Instructions for Use
ARTEN100151704 Rev. A Example 1 (atrial mapping with multiple distinct cycle length atrial tachy- 11

Example 1 (atrial mapping with multiple distinct cycle length atrial

tachycardias)

In the atrial chambers, physicians may want to automatically collect mapping points as long as the intracardiac (CS, HIS, etc) measured
Cycle Length is within +/- XX ms of the original template beat (first point saved into the map). In the example below the physician
simultaneously and automatically built the right atrial anatomy and atrial tachycardia LAT timing and voltage maps in the right atrium
by:
1. Collecting anatomic modeling points with the OneMap™ feature (this allows mapping points and anatomic modeling points to
be collected simultaneously).
2. Saving the first atrial tachycardia (Cycle Length 1) beat into the map, ensuring that the Roving Activation Interval does not
include a ventricular complex.
3. Checking the "Cycle Length Tolerance" box and setting it to +/- 20 ms.
4. Checking the "Score Threshold" box and setting it to 50 (this may eliminate roving catheter points polluted with far field
ventricular activity).
5. Clicking "Start AutoMap".

6. If a secondary atrial tachycardia (Cycle Length 2) was intermittently occurring during original mapping, the user can save one of
those points into a new map, pulling up the primary AutoMap mapping segment, setting the AutoMap Settings for the secondary
map, and clicking TurboMap speed to generate this new map with the TurboMap feature.
 EnSite™ AutoMap Module Instructions for Use
12 Example 2 (ventricular mapping with multiple distinct surface lead ARTEN100151704 Rev. A

Example 2 (ventricular mapping with multiple distinct surface lead

morphologies)

In the ventricular chambers physicians may want to automatically collect mapping points as long as the surface lead morphology is
XX% similar to the template beat (first point saved into the map). For example the physician can simultaneously and automatically
build the left ventricle anatomy and Sinus Rhythm voltage/timing maps in the left ventricle by:
1. Collecting anatomic modeling points with the OneMap™ feature (this allows mapping points and anatomic modeling points to
be collected simultaneously).
2. Saving the first Sinus Rhythm beat into the map.
3. Checking the "Score Threshold" box and setting it to 90.
4. Clicking "Start AutoMap".

NOTE: When the surface lead morphology is not 90% similar to the template Sinus Rhythm 12-lead Surface Morphology, the
red box turns red indicating that mapping points were not collected because the Surface Lead Morphology Match Score
was outside the morphology of interest. This feature can be used to automatically reject ectopy as the ectopy would not
be 90% similar to the template beat.

In some instances secondary arrhythmias may intermittently occur during primary map collection. If this occurs, the physician could
use the TurboMap feature to create a map with points only associated with that secondary intermittent arrhythmia by:
1. Record a segment when the secondary arrhythmia occurred during primary map collection.
2. Saving a mapping point of the secondary arrhythmia into a new map.
3. Pulling up the AutoMap Mapping Segment of the original map
4. Clicking Start AutoMap
5. Selecting TurboMap speed to play back through the original dataset at 10x’s real-time speed
6. Selecting Play on the segment

NOTE: When the surface lead morphology is not 90% similar to the secondary arrhythmia template beat morphology, the red
box turns red indicating that mapping points were not collected because the Surface Lead Morphology Match Score was
outside the morphology of interest.

This same concept could be applied to other secondary arrhythmias that occurred during the original map creation.
EnSite™ AutoMap Module Instructions for Use
ARTEN100151704 Rev. A Example 3 (pace mapping using Score Map) 13

Example 3 (pace mapping using Score Map)

In a Pace map, it is possible to automatically collect mapping points at any surface lead morphology as long, as the pacing impulse
has been captured.
1. Collecting anatomic modeling points with the OneMap™ feature allows mapping points and anatomic modeling points to be
collected simultaneously.
2. Mapping detection settings (Figure 2).

Figure 2. AutoMap Detection Settings for Pace Mapping

a. Ref – Multiple ECG (Use full 12-lead for scoring and timing)
b. Roving – Pacing catheter (pacing pair only). Example, D-2 if pacing from D-2.
3. AutoMap Threshold settings (Figure 3).

Figure 3. AutoMap Threshold Settings for Pace Mapping Using Score Map
a. Default map setting for Speed (10 mm/sec) and Signal to Noise (5.0).
b. Score Threshold set to 0.
c. CL Tolerance threshold OFF.
d. Distance threshold OFF.
e. Enhanced Noise Rejection OFF.
4. Freeze a beat of interest.
5. Set the Reference Offset to the onset of the QRS.
6. Set the Independent Scoring Interval to the QRS duration (onset to terminal).
 EnSite™ AutoMap Module Instructions for Use
14 Example 3 (pace mapping using Score Map) ARTEN100151704 Rev. A

7. Set the Roving Activation Interval (RAI) so the pacing spike is included and the RAI is less than or equal to pacing cycle length
(approximately 80%-90% or -20ms to -30ms).
8. Save the beat of interest.
9. Click “Start AutoMap.”
10. Once points are collected, click the Stop AutoMap button. Review the mapping points and sort by LAT. Make sure that the
Points filter (that hides unused points) is not selected. Delete any points with LAT values that are greater than 0ms. These points
are non-capture pacing beats (Figure 4).

Figure 4. Points filter off, sort by LAT, delete all points with a positive LAT
11. Sort the mapping points by Score.
12. Set the mapping color bar so the color range is 90-100 (%)

NOTE: Do not change the reference offset after saving the first beat when using Score Map. Changing of the reference offset
after the first beat may lead to an incorrect mapping display.
EnSite™ AutoMap Module Instructions for Use
ARTEN100151704 Rev. A Automatic Non-Cardiac Triggered Maps 15

Automatic Non-Cardiac Triggered Maps

AutoMap can be used for creating non-cardiac triggered maps as well. AutoMap is started the same way as cardiac-triggered maps.

NOTE: AutoMap Score Threshold and CL Tolerance are unavailable for Non-Cardiac Triggered maps.

Figure 5. Automatic Non-Cardiac Triggered Map

1. Start a new map.
2. Change to non-cardiac triggered map and set up mapping parameters, including AutoMap settings.
3. Save the first point manually by clicking freeze and save.
4. Click the Start AutoMap button to start acquiring points.
5. Click Stop AutoMap when done acquiring points.

Stable Distance Indicator

When the Point Collection Status is shown, the speed limit indicator is replaced with the Stable Distance indicator. The Stable Distance
indicator shows the stability of the catheter in the form of a pie graph. The longer the catheter is stable, the more slices of the pie are
colored green. The pie graph is full when all the mapping electrodes haven't moved more than the Stable Distance millimeters for the
time period specified by the Segment Length control. When the AutoMap Stable Distance Threshold is enabled, the system will not
acquire a point until the pie is all green. This prevents the system from acquiring a point when the catheter has moved part-way through
the acquisition period.

NOTE: The Stable Distance indicator is only applicable to non-cardiac triggered maps.
 EnSite™ AutoMap Module Instructions for Use
16 Automatic Non-Cardiac Triggered Maps ARTEN100151704 Rev. A