EnSite Precision™ Cardiac INSTRUCTIONS USE Mapping … - Precision V2.0 (E).pdf · ELDI Field Upgrade Kit EnSiteTM ArrayTM Catheter cable connector EnSiteTM VelocityTM Cardiac Mapping

1

EnSite Precision™ Cardiac

Mapping System

Model EE3000

INSTRUCTIONS FOR USE

U.S. EDITION

Software Version 2.0

© 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.

This software includes a custom version of the AVW Toolkit:

Copyright (c) 1995-2015 Biomedical Imaging Resource, Mayo Clinic/Foundation.

This software includes the DST Digital Segmentation Tool:

Copyright (c) 2004-2015 Biomedical Imaging Resource, Mayo Clinic/Foundation.

Valleylab is a trademark of Covidien AG.

DICOM is a trademark of National Electrical Manufacturers Association

CIDEX and CIDEX OPA are trademarks of Johnson & Johnson Corporation.

SANI-CLOTH is a trademark of Professional Disposables International, Inc.

ARTEN100141614 Rev. A2015-12

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 Zaventem Belgium+32 2 774 68 11www.sjm.com

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

WARNING: The use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.

2 EnSite Precision™ Cardiac Mapping System Instructions for UseARTEN100141614 Rev. A

Symbol Description

21” Monitor

24” Monitor

Ablation Cable Kit, EPT

Ablation Cable Kit, IBI, T9

Ablation Cable Kit, Stockert

Ablation Cable Kit, JLL

Ablation catheter cable connector

Ablation catheter cable connector

ACT

AC Power

Adapter Assembly, ECG/NavX

Amplifier Network Connection

Amp and Chassis

Amplifier

Amplifier Accessory Kit

Amplifier and Display Workstation

Amplifier Cart

Amplifier Kit

Bedrail Mount Kit

Authorized representative in the European community

Auxiliary Reference Cable Connector

21” Monitor

24” Monitor

Amp and Chassis

Amplifier

Amplifier Accessory Kit

Amplifier Cart

Amplifier Kit

Cable Accessory Kit

Cable from RecordConnect to EnSiteTM Amplifier

Cable to Bard-Clearsign recording system

Cable to Bard-Stamp recording system

Cable to GE-Cardiolab recording system

Cable to St. Jude Medical EP-Workmate recording system

Cardiac Mapping System

Catalog Number

Catheter

Catheter Catalog Installation

Catheter Impedance Checker

CIM Certificate

Catheter Input Module (for the recording system in use)

Catheter Input Module Cable Connector




Catheter Interface Module cable connection for catheter inputs 1-56

Symbol Description

CIM

3EnSite Precision™ Cardiac Mapping System Instructions for UseARTEN100141614 Rev. A

Catheter Interface Module cable connection for catheter inputs 57-120

Caution

Warning

Class II equipment

Consult Instructions for Use

Contents

Data Module Connector

Data Network Connection

Date of Manufacture

Defibrillator-proof Type BF applied part

Defibrillator-proof Type CF Applied Part

Dispersive Patch Cable Connector




Symbol Description

Display Workstation

Display Workstation Kit

Dispose of hardware in accordance with local law

Do not reuse

Do not use if package is damaged

DWS Hard Disk Drive

DWS Kit

ECG cable connector

ECG or RecordConnect ECG Cable Connector

ECG Surface Electrode

ELDI Field Upgrade Kit

EnSiteTM ArrayTM Catheter cable connector

EnSiteTM VelocityTM Cardiac Mapping System Amplifier

Equipotential Cable

Equipotential jack

Symbol Description

ELDI Field Upgrade Kit

EnSite VelocityTM Amplifier

Equipotential Cable


ETL Listed Conforms toUL STD 60601-1 IEC STD 60601-1-1Certified toCAN/CSA STD C22.2 NO. 601.1ETL Listed Conforms toAAMI ES 60601-1 Certified toCSA G 22,2 NO. 60601-1

European Customer Service

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

EXP

Field

Field Frame Bracket

Field Frame Cable

Follow Instructions For Use

For Use With

Fragile

Fragile

Fuse

GenConnect

GenConnect Cable Connector, to EnSiteTM Amplifier

Hardware

HN

Hospital Network Connection

Symbol Description

European Customer Service

Humidity Limitation

Includes

Input Voltage, Input Frequency andReplacement fuse information

Interface between Biosense Webster - Stockert ablation generator and the EnSiteTM Amplifier

Interface between diagnostic catheters and the EnSiteTM Amplifier

Interface between EnSite™ NavX™ Navigation and Visualization Technology patches / system reference and the EnSiteTM Amplifier

Interface between EnSite Precision™ Cardiac Mapping System EnSiteTM

ArrayTM catheter / data module and the EnSiteTM Amplifier

Interface between EPT ablation generator and the EnSiteTM Amplifier

Interface between manufacturer-specific generators and the EnSiteTM Amplifier

Interface between manufacturer-specific recording systems and the EnSiteTM Amplifier

Interface between Medtronic Atakr ablation generator and the EnSiteTM Amplifier

Interface between Siemens-Sensis recording system and the EnSiteTM Amplifier

Interface between SJM-T Series (formerly IBI-T Series) ablation generator and the EnSiteTM Amplifier

International Power Kit

International Rail Clamp

Keep Dry

Symbol Description

Intl Power Kit

Intl Rail Clamp


Keep Dry

Kit

Kit, CoHesion 3D Visualization Module

Kit, WetLab

Laptop Review Station

Link

Local Monitor Connection

Lot number

Made in U.S.A.

Patient Reference Sensor

Field Frame

EnSite Precision™ Field Frame Patient Orientation

Manufactured By

Model Number

Module

Monitor Arm

Mounting Kit

Multi-electrode Diagnostic Catheter

Non Sterile

Link

Symbol Description

Laptop Review Station

Made in U.S.A.

MODEL

Monitor Arm

Multi-electrode Diagnostic Catheter

Not for direct patient contact

Notified Body CE Mark

On ArrayLink™ cable: ArrayLink™ cable connectororCathLink™, or RecordConnect catheter channels 65 to 128 cable connector

On ArrayLink™ cable: ArrayLink™ Data Module cable connector

On carton: Transport/storage temperature limitation

On carton: Transport/storage temperature limitation

On CathLink™ or RecordConnect cable: CathLink™ or RecordConnect catheter channels 1 to 64 cable connector

On the EnSiteTM Amplifier: ArrayLink Data Module cable connector

On the EnSiteTM Amplifier: ArrayLink, CathLink, or RecordConnect catheter channels 65 to 128 cable connector

On the EnSiteTM Amplifier: CathLink or RecordConnect catheter channels 1 to 64 cable connector

On the EnSiteTM Amplifier: ECG or RecordConnect ECG cable connector

On the EnSiteTM Amplifier: Fiber optic Cable Connector

On the EnSiteTM Amplifier: GenConnect cable connector

On the EnSiteTM Amplifier: NavLink™ Module cable connector

On GenConnect: GenConnect cable connector

Symbol Description

-25 C

+55 C


On NavLink™ Module: NavLink™ Module cable connector

Operating Temperature

Power Plug

Power Switch

Printed Circuit Assembly

Printer

Port 1

Port 2

Port 3

Port 4

Power

Atmospheric Pressure Limits

Quantity

RecordConnect

Recorder Interconnect Kit, EPMED V5.0

Remote Monitor Connection

Remote Monitor Stand

Research Switch

Symbol Description

+18 C

+27 C

Printer

Remote Monitor Stand

Research Workstation

RF Filter

RF Filter Trap for Stockert

Serial Number

Small Surface Electrode Kit

Software

Software Installation

Software Upgrade Kit

Standby Power

Status

Sterilized Using Ethylene Oxide

Surface Electrode Kit

System Reference Patch Connector

Training Media

Universal RecordConnect

US Customer Service

US Power Kit

US Rail Clamp

Use By Date

Utility Upgrade Kit

Symbol Description

Small Surface Electrode Kit

Software Upgrade Kit

STERILE EO

Surface Electrode Kit

US Customer Service

US Power Kit

US Rail Clamp


Weight

Workstation

Workstation Accessory Kit

Workstation Cart

Symbol Description

Workstation

Workstation Accessory Kit

Workstation Cart


Introduction

Indications for Use

The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ Precision System interfaces to either the MediGuide™ Guided Medical Positioning System or the EnSite Precision Module to combine and display magnetic processed patient positioning and orientation mapping information.

■ When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in theright atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

OR

■ When used with an EnSite™ NavX™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended todisplay the position of conventional electrophysiology (EP) catheters in the heart.

System Description

The EnSite Precision™ Cardiac Mapping System (Figure 1 on page 13) is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional and sensor enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient’s own cardiac chamber.

Figure 1. The EnSite™ Amplifier and Cart (left), DWS and Cart (right).


Key System Features

Catheter Catalog – Catheter-specific information, including catheter diameter, tip electrode size, body electrode size, type, and interelectrode spacing, can be saved to a searchable catalog.

Clipping Plane . The clipping plane helps to increase the understanding and relationship of the model to other related features while reducing visualization obstructions.

Contact Mapping. Maps can be created from conventional EP catheters. Maps can display various information, including: activation timing, peak-to-peak voltage, peak-negative voltage, or complex fractionated electrograms.

■ MultiPoint Mapping Technology – Map points can be added from the active electrode, all electrodes on a specified catheter, or allelectrodes in use.

■ Low -V ID – An adjustable Low Voltage Identification (Low -V ID) option allows low-voltage potentials to appear in gray insteadof affecting the color pattern. Low - V ID is available for Local Activation Time (LAT) isochronal maps and Complex FractionatedElectrogram (CFE) maps.

Data Storage and Export Capabilities. During an EP study, the monitors display the data and that data can be stored on the DWS hard drive. Once the study is complete, a prompt is displayed to remind the user to back up the study data.

■ Patient records are stored in a database searchable by patient name, patient weight, physician name, date, diagnosis, and studytype.

■ Records are copied to CD/DVD, USB, and network drive.

■ Still images, animations, and study data can be exported to a CD/DVD, USB, and network drive, which can then be displayed andreviewed using a non-EnSite Precision™ Cardiac Mapping System computer.

■ The study images can be printed using a color printer.

DEMRI – Delayed Enhancement Magnetic Resonance Imaging.

DIF Map – Digital Image Fusion Map.

Digital Image Fusion (DIF). Digital images processed by segmentation tools such as the EnSite™ Verismo™ Segmentation Tool can be imported into the EnSite Precision™ Cardiac Mapping System for display.

EnGuide Stability Monitor – The EnSite Precision™ Cardiac Mapping System has the ability to check for unexpected changes in sensor enabled EnGuide locations. Sensor enabled catheter required.

Field Scaling. – Field Scaling can be configured to automatically scale model, map, and EnGuide catheter locations and facilitates distance measurements. Two Field Scaling options are available:

■ EnSite™ NavX™ Navigation and Visualization Technology (NavX): Known interelectrode spacing used to create the model isused to adjust the dimensions of the navigation field.

■ EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ (NavX SE): Known offsets between the positionand orientation of sensor(s) and electrodes on St Jude Medical Sensor Enabled catheters are used to adjust the dimensions of thenavigation field.

First Deflection – Searches for the first spot in the signal (from left to right) where the signal deviates from baseline by at least the sensitivity amount

Fractionation Map – Displays the area of the map where there are clusters of Fractionation and is useful in identifying noisy points or points that require more attention.Indicates the number of CFE detections.

Image and Animation Export (Offline Review only). Several options allow images and animations to be captured from the system:

■ Image sequences can be exported as either a series of JPEGs or as an mpeg (.mpg) movie.


Last Deflection – Searches for the last spot in the signal (the first spot when scanning from right to left to right) where the signal deviates from baseline by at least the sensitivity amount.

Metal Distortion Meter – Displays the magnitude of the largest metal distortion deviation, indicating possible interference of the magnetic field due to the proximity of a metal object.

Models of Cardiac Chambers. The EnSite Precision™ Cardiac Mapping System can generate a model of one or more of the patient’s cardiac chambers by tracking conventional EP catheter electrodes at various locations on the surface of the endocardium.

Noncontact Mapping. (EnSite™ Array™ Catheter studies only) When the EnSite Precision™ Cardiac Mapping System is used along with the EnSite™ Array™ Multi-Electrode Catheter, the system can collect, store, and display more than 3000 intracardiac electrograms. Several tools are available to facilitate interpretation:

■ AutoFocus Color Controls allow the system to automatically adjust the color levels of isopotential maps to quickly and clearlyidentify activation patterns.

■ Isopotential Mapping displays voltages sensed by the EnSite™ Array™ Catheter as three-dimensional maps, which use color torepresent a range of electrical potentials across the surface of the heart chamber’s endocardium. These maps contain the electricalpotentials at thousands of sites on the endocardial surface. As dynamic cardiac signals are viewed in the waveform display, thesame information is animated in the display of the isopotential map.

■ Single-Beat Isochronal Maps of activation time can be projected onto the surface of the anatomic model in review mode.

■ Substrate Mapping (SM) Tool allows voltage patterns from noncontact mapping to be displayed as maps and labeled on the map.

■ Virtual Waveforms are based on simulated electrodes placed on the map display.

Non-fluoroscopic Catheter Navigation. The EnGuide navigation system allows 3D navigation of conventional EP catheters.

Notebook. The notebook allows recorded data and study information to be filed and annotated for future access.

■ Bookmarks can be added to the Notebook to allow the system to return to a specific time in review mode.

■ Events can be added to the Notebook to mark specific times in a study, such as the time of a drug administration.

OneMap. This feature is used to simultaneously create a cardiac chamber model and a contact map.

Point Count Map – Provides a method to visualize areas of high map point density versus low map point density.

Presets. Presets store setting preferences for catheters, models, maps, and layouts.

Propagation Maps. This feature facilitates the playing back of the activation sequence of recorded reentrant maps.

■ Provides controls to turn this feature on/off and features to control the playing through the activation sequence.

■ Loops over the cycle length.

■ Export of propagation sequences are available only in Offline Review.

Reentrant Maps. These maps facilitate the mapping of reentrant arrhythmias and are displayed in a manner similar to activation maps.

Respiration Compensation. (EnSite Precision™ and EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies only.) Respiration Compensation can be configured to dynamically adjust to the motion artifact from patient respiration during an EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ study. Respiration Compensation can also be manually recomputed during a study.

■ Respiration Meter – A respiration meter displays the relative level of patient respiration in the map display, based on EnSite™NavX™ Navigation and Visualization Technology, Sensor Enabled™ transthoracic impedance. The range is based on the lowestand highest impedance values sampled during Respiration Compensation collection.

■ Respiration Rejection – If a patient’s respiration exceeds the set limits of the respiration levels collected during Data Collection,the system will stop collecting points and stop placing labels and lesions at the Active EnGuide.

RF Filtering. Hardware filters provide cleaner signals during RF ablation.


Saturation Recovery. Saturation Recovery allows the system to quickly recover signals following defibrillation or RF energy ablation. Rapid system recovery allows assessment of post-defibrillation or post-ablation complexes.

Score Map – Provides a method to visualize areas of map points matching the morphology of the selected ECG signal.

Screen Views. The interface can be configured to display different types of information. Various options are available to display waveforms, one or two maps, and split screen.

Sheath Filter – Determines if an electrode is within the sheath (Sheathed) or outside the sheath (Unsheathed).

Signal Recording and Display. The EnSite Precision™ Cardiac Mapping System is designed to collect, record, and display surface ECG and intracardiac electrogram signals provided by ECG electrodes, conventional EP catheters, other EP laboratory equipment, and the EnSite™ Array™ Catheter.

Sort Options – The user can sort the collected map points by the following criteria:

■ Order of Collection

■ LAT

■ Peak to Peak

■ Peak Negative

■ CFE Mean

■ CFE Std. Dev.

■ Fractionation

■ Annotation

■ Cycle Length

■ Point Count

■ Point Status

■ Wave Name

■ Force

Sparkle Map – Live activation map overlaid on the voltage map for easy visualization of voltage pathways on a single map.

Stabilize ABL – The Stabilize ABL feature adjusts the location of the distal electrode, based on the properties of the catheter.

Tape Measures. Tape measures allow measurement between points on the anatomic model of the endocardial surface.Tools to Provide Map Orientation. Several tools are available to enhance map orientation.

TurboMap – Once original mapping has occurred, the user may change mapping criteria and play back through the original dataset at maximum speed to generate a new map at 10x’s real-time speed. As an example, if the original mapping time were 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.

Waveform Traces. The EnSite Precision™ Cardiac Mapping System has capabilities similar to traditional EP recording systems, including the ability to collect, store, and display surface ECG and intracardiac electrograms as waveform traces.


System Components

The EnSite Precision™ Cardiac Mapping System is comprised of two subsystems: the EnSite™ Amplifier and the Display Workstation (DWS).

EnSite™ Amplifier

The EnSite™ Amplifier subsystem consists of the EnSite™ Amplifier, NavLink™ Module, ArrayLink™ Module, CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect. The devices accept signals from electrodes attached to the patient and pass these signals to the EnSite™ Amplifier. The EnSite™ Amplifier converts these signals to a digital format and sends them to the DWS for processing.

EnSite™ Amplifier. Accepts signals from the NavLink™ Module, the ArrayLink™ Module, the CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the DWS for processing. The Amplifier is connected to the DWS through a fiber-optic cable.

EnSite Precision™ Module, Sensor Enabled™. Consists of the EnSite Precision™ Link, Sensor Enabled™, the EnSite Precision™ Field Frame, and two (2) Patient Reference Sensors.

NavLink™ Module. Connects the EnSite™ surface electrodes and the system reference surface electrode to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode.

ArrayLink™ Module. Connects the EnSite™ Array™ catheter to the EnSite™ Amplifier.

CathLink™ Module. Connects diagnostic catheters to the EnSite™ Amplifier.

SJM ECG cable. Connects standard ECG electrodes to the EnSite™ Amplifier.

RecordConnect. Connects a recording system to the EnSite™ Amplifier without the need for jumpers. A different RecordConnect model is required for each make of recording system.

GenConnect. Connects the ablation catheter and dispersive surface electrodes to the EnSite™ Amplifier. It isolates the EnSite Precision™ Cardiac Mapping System location signal from being loaded by the ablation generator, thereby eliminating the need for separate dispersive electrode filters. A different GenConnect model is required for each make of ablation generator.

NOTE: GenConnect is not necessary when using the Ampere™ Generator.

Display Workstation (DWS)

The DWS consists of the workstation (computer), monitors, medical grade isolation transformer, video extender, media converter, and Ethernet switch .

Workstation. The workstation contains the system software displaying data from the EnSite™ Amplifier. Attached to the workstation are a keyboard and mouse for user input.

Monitors. Monitors are used to display patient information. One monitor is placed near the workstation and keyboard for system operation, and an optional second monitor can be placed near the patient table for use by the physician. The monitors display identical information from the same source.

Medical Grade Isolation Transformer. All system components on the DWS cart are connected to line power through the isolation transformer. Only components of the DWS should be connected to this isolation transformer.

Video Extender. This device splits the video signal so that the same information appears on both of the EnSite Precision™ Cardiac Mapping System monitors.


Media Converter. The Media Converter converts optical signals to digital signals. It connects to the hardware via a Fiber Optic Cable and connects to the DWS via an Ethernet cable and a USB cable, which is used for power only.

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

Components Not Included

The following components are required for EP studies but are not included with the EnSite Precision™ Cardiac Mapping System.

EnSite™ Array™ Catheter. This noncontact multi-electrode catheter collects cardiac electrical information.

Conventional and Sensor Enabled EP Catheters . These catheters are introduced into the cardiac chamber of interest and placed in contact with the chamber wall.

■

Surface Electrodes – Six surface electrodes are used for the EnSite™ Cardiac Mapping System.

Patient Reference Sensor Patches – Two patches are used to place the two Patient Reference Sensors (PRS) that are used with the EnSite Precision™ Cardiac Mapping System.

ECG Electrodes. These industry-standard surface electrodes are placed in a standard 12-lead configuration.

System Reference Surface Electrode. A system reference surface electrode is required for all EnSite™ ArrayLink™ Module and EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies. This surface electrode should be suitable for defibrillation or electrosurgery, such as the Valleylab™ Single Use Patient Return Electrodes (see below).

Figure 2. Valleylab™ Single Use Patient Return Electrode

A system reference surface electrode is included in the EnSite Precision™ Surface Electrode Kit.

Printer. An optional printer is available for printing images and waveforms.

Remote Monitor. The Remote Monitor can be purchased separately. This monitor is typically used in the Patient area of the lab, where the DWS may only be available in the control room.


EnSite™ Cardiac Mapping System Diagram

Typical EnSite Precision™ Cardiac Mapping System Lab Setup

Figure 3. EnSite Precision™ System Setup.

Table 1.

Figure 3. EnSite Precision™ System Setup.

1 Remote Monitor Stand 7 EnSite Precision™ Link, Sensor Enabled™, CathLink™ Module, NavLink™ Module

2 Monitor Boom (Patient Monitors) 8 Field Frame cable to the EnSite Precision™ Link, Sensor Enabled™, routed under the patient table

3 EnSite™ Amplifier 9 Patient Table

4 Fiber Optic Cables 10 Workstation

5 C Arm 11 Monitor

6 EnSite Precision™ Field Frame and bracket 12 Keyboard and Mouse


Signal and Power Connections

EnSite Precision™ Display WorkStation (DWS) Connections

Figure 4. Signal and power connections for an EnSite Precision™ Cardiac Mapping System configuration.


Warnings and Cautions

WARNING: A warning contains information for avoiding hazards that represent a significant hazard to the patient or operator. Warnings are also used for hazards that could significantly harm the EnSite Precision™ Cardiac Mapping System.

CAUTION: A caution contains information for avoiding hazards to the system components or improper system performance.

Operator Requirements. The EnSite Precision™ Cardiac Mapping System must be operated by, or under the supervision of, an electrophysiologist trained in the operation of the EnSite Precision™ Cardiac Mapping System and supported by other qualified personnel trained in the field of cardiac EP. It must be used in conjunction with other equipment required for electrophysiology studies such as suggested by the North American Society of Pacing and Electrophysiology1 (a.k.a. Heart Rhythm Society) and the American Heart Association2.

Support Equipment. The EnSite Precision™ Cardiac Mapping System is not intended for use as a primary ECG monitor. During EnSite Precision™ Cardiac Mapping System studies, an ECG monitor that conforms to safety requirements defined in IEC 60601, designated as the primary ECG monitor, must be present.

Connections to non-EnSite Precision™ Cardiac Mapping System equipment. Observe the following:

CAUTION: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices) may create a location shift.

■ Do not modify or make any additional connections to the EnSite Precision™ Cardiac Mapping System, other than those described in this manual.

■ Do not connect the system to multiple portable socket outlets or extension cords.

Patient Safety. Observe the following:

WARNING: For patient safety, any connections that directly connect the patient to the EnSite Precision™ Cardiac Mapping System must be routed through the appropriate module: EnSite Precision™ Link,Sensor Enabled™ NavLink, EnSite Precision™ Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect.

WARNING: When using the EnSite Precision™ Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.

CAUTION: The EnSite™ Array™ Catheter is intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.

CAUTION: The EnSite Precision™ Surface Electrode Kit, Sensor Enabled™ is intended for single use only. Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.

■ Do not touch non-medical equipment and the patient at the same time.

Damaged Cables. Between studies, inspect cables for insulation or connector damage. Replace damaged cables immediately.

Validating the EnSite™ Array™ Catheter. Always have the EnSite™ Array™ Catheter inserted into the patient before validating the catheter in the software.

Validating EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™. Before validating EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ make sure that all connections have been made between the EnSite™ Amplifier and DWS. Ensure that the EnSite™ NavLink™ Module is connected to the EnSite™ Amplifier and that all EnSite Precision™ surface electrodes have been connected as described. In particular, make sure that the left leg surface electrode is connected to the EnSite™ NavLink™ Module.

1. Waldo, AL, et. al, “NASPE Policy Statement: The Minimally Appropriate Electrophysiologic Study for the Initial Assessment of Patients with Documented Sustained Monomorphic Ventricular Tachycardia,” PACE, v. 8, pp 918-922, 1985.

2. Gettes, LS, et. al., “AHA Committee Report: Personnel and Equipment Required for Electrophysiologic Testing,” Circulation, v. 69, pp 1219A-1221A, 1984.


External Stimulation. When using stimulus inputs on multiple EP systems, use care not to deliver stimulus through multiple paths.

Software Warning Messages. Caution: Always respond to warning messages as soon as possible. Failure to do so may cause an inability to record data or to communicate properly with the EnSite™ Amplifier.

Navigation. Adhere to the following to ensure accurate navigation:

CAUTION: Make all connections between systems before validating EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™. Adding or removing connections after validation may affect navigation quality. Additionally, all patient connections to ancillary equipment (e.g. external defibrillators) should be made prior to validation. Connections between systems refers only to SJM-supplied or approved devices.

CAUTION: When the EnSite™ Amplifier is turned off, it can affect ECG signals viewed on the recording system. When the EnSite™ Amplifier is turned off and a recording system is in use, it is recommended that the cables to the EnSite™ Cardiac Mapping System be disconnected from the EnSite™ Amplifier.

WARNING: Do not use Stabilize ABL in situations where the proximal electrodes on the ablation catheter may be covered by a sheath.

CAUTION: (EnSite™ Array™ Catheter studies) If the EnSite™ Array™ Catheter is repositioned or unintentionally moved, a new model must be created. If a new EnSite™ Array™ Catheter is introduced, a new study must be started.

■ For EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies, a new study must be started if any ofthe EnSite Precision™ surface electrodes are repositioned.

■ EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies intending to use Field Scaling must nothave electrodes in a sheath during point collection.

NOTE: Using location information from non-functional electrodes may yield unexpected Field Scaling results. This cannot be reversed. However, the use of Field scaling is optional and can be unapplied if unexpected results are seen.

■ Check for and disable non-functional electrodes or electrodes in a sheath before creating a model. Collecting points from non-functioning electrodes or electrodes in a sheath can result in unexpected field scaling results. See “Field Scaling”.

Noncontact Mapping. Use appropriate techniques when interpreting data from noncontact maps:

CAUTION: When placing bipolar virtual electrodes near the poles of the map, select latitudinal orientations. Failure to do so may cause the electrograms to be computed improperly, resulting in inaccurate traces.

CAUTION: If the high pass filter is set to low frequencies (< 2Hz), signals may be subject to low-frequency baseline drift.

CAUTION: In the caliper measurements for noncontact isochronal maps and Substrate Mapping, do not use portions of the waveform display that have purple waveforms.

CAUTION: If the EP catheter electrode is not in contact with the endocardium, the comparison between the EnGuide virtual electrogram and the EP catheter electrode may not accurately reflect the relationship between these signals.

CAUTION: Do not disconnect the Array Module from the EnSite™ ArrayLink™ Module or the EnSite™ ArrayLink™ Module from the EnSite™ Amplifier during a study.

Shutting Down the Workstation. To shut down the workstation, always follow the instructions in “Ending a Study”.

WARNING: If the workstation is powered off by the user, rather than shutdown by the operating system, data on the hard drive may become corrupted and the EnSite Precision™ Cardiac Mapping System may cease to be operational.

Removable CD/DVD Handling. CD/DVDs must be handled with care. Do not allow CD/DVDs to fall onto a hard surface. Do not place paper labels on the CD/DVD, write directly on the CD/DVD.

Surface Electrodes and Patient Reference Sensor (PRS) Patches. Use care in applying and removing surface electrodes (ECG, system reference, EnSite Precision™ surface electrodes) and PRS patches:


CAUTION: Ensure that surface electrodes, Patient Reference Sensors, and associated connectors do not contact one another, electrical ground, or metallic objects.

CAUTION: Do not attempt to connect the system reference surface electrode for the EnSite Precision™ Cardiac Mapping System to other equipment, such as ablation systems.

CAUTION: The system reference surface electrode must be the first patient electrode connected to the EnSite™ Amplifier at the beginning of a study, and the last patient electrode to be disconnected at the end of the study.

CAUTION: When removing the system reference surface electrode from the patient’s abdomen, disconnect the patch from the patient before disconnecting its jack from the EnSite™ NavLink™ Module.

CAUTION: Do not warm the ECG surface electrodes before they are positioned on the patient.

CAUTION: Do not warm the EnSite Precision™ surface electrodes before they are positioned on the patient.

CAUTION: Do not warm the system reference surface electrode before it is positioned on the patient.

WARNING: Do not use surface electrodes if the package seal is broken, the conductive adhesive is dry, or the “use by” date has passed.

WARNING: Before applying the EnSite Precision™ surface electrodes, ensure that the application sites are hair-free, clean, and dry. Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.

WARNING: Before applying the System Reference surface electrode, ensure that the application site is hair-free, clean, and dry. Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.

Liquids . System components are susceptible to damage from liquids. Keep liquids away from this equipment.

Sterilization and Cleaning. Keep this in mind:

CAUTION: Do not clean the system components with disinfectants that contain surfactants.

CAUTION: Do not clean system components with bleach.

CAUTION: Do not apply cleaners while the system is warm to the touch.

CAUTION: Do not sterilize system components.

CAUTION: Do not sterilize EnSite Precision™ Cardiac Mapping System interconnect cables.

CAUTION: Do not immerse system components in liquid.

CAUTION: Do not operate the EnSite Precision™ Field Frame within 10 m of another operating Field Frame.

CAUTION: Do not place the EnSite Precision™ Field Frame cable inside the measurement volume or wrap it around the Field Frame, as it may create a magnetic interference.

CAUTION: Do not coil the EnSite Precision™ Field Frame cable. The cable carries enough electric current that a magnetic field will be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame's magnetic field.

CAUTION: Do not place the EnSite Precision™ Link, Sensor Enabled™ within 1 m of the EnSite Precision™ Field Frame.

CAUTION: Do not place tool cables within 30 mm of the EnSite Precision™ Field Frame cable. If placed this close-particularly if the cables are parallel to each other-the tool cable may become subject to electromagnetic interference.

CAUTION: Do not use the EnSite Precision™ Cardiac Mapping System in the presence of other magnetic fields.

CAUTION: Do not drop the EnSite Precision™ Field Frame or subject it to impact. Physical damage to the Field Frame may alter the Field Frame's factory calibration.


CAUTION: Do not disconnect the EnSite Precision™ Field Frame from the system while tracking. Disconnecting the Field Frame while in tracking mode may result in sparks being generated.

CAUTION: Do not expose or immerse the EnSite Precision™ system to liquids, or allow fluid to enter the equipment in any way. Exposing the EnSite Precision™ system to liquids may result in equipment damage, produce a fire or shock hazard, and result in possible personal injury.

CAUTION: Disconnect power to the EnSite Precision™ system before cleaning it.

CAUTION: Do not use aerosol sprays near the equipment as these sprays can damage circuitry.

CAUTION: Do not autoclave any Precision system component. Autoclaving may damage the system.

CAUTION: Do not leave cable connectors where they can be damaged, particularly on the floor, where they can easily be stepped on and damaged.

CAUTION: Pull connections apart by gripping the connector. Do not pull them apart by tugging on the cable as this can damage the connecting cable. Never force a connection or a disconnection.

Hardware Disposal. The EnSite Precision™ Cardiac Mapping System contains electronic printed circuit board assemblies that may contain lead-based solder. Disposal of the equipment must be in accordance with local laws.


Best Practices and Recommendations

Operating Environment. Ensure that the following requirements are maintained:

■ To protect the privacy and security of sensitive information, including protected health information (PHI), the system should belocated in a secured environment.

■ All system connections are in place, securely fastened, and functional.

■ Proper grounding and patient isolation standards are maintained.

■ Cables from catheters connected directly to the patient are placed to avoid inadvertent damage or unintentional movement.

■ Proper support equipment (e.g., defibrillation unit, ECG monitor, etc.) is on site for immediate response to patient distress.

■ Proper ventilation is present. The system components are not suitable for use in the presence of flammable gases, includingflammable anesthetic mixtures. Do not block the vents on the rear of the EnSite Precision™ Link, Sensor Enabled™ with drapesor other materials.

NOTE: Refer to “Technical Specifications” for specific environmental electromagnetic specifications and recommendations.

NOTE: Activate security settings, individual user logins, and passwords per the Administrators Guide For the EnSite™ Cardiac Mapping System.

Power Sources. Adhere to the following requirements for power sources:

■ Use properly grounded power outlets with appropriate circuit breaker ratings:

– Workstation and monitors: at least 8.0A at 110V , at least 4.0A at 230V .

– EnSite™ Amplifier: at least 4.0A at 110V , at least 2.0A at 230V .

■ The EnSite™ Amplifier should be turned on and allowed to run for at least 30 minutes before beginning a study.

Compatible Components. The EnSite Precision™ Cardiac Mapping System has been tested to meet the safety requirements of IEC 60601-1. Use of components other than those specified by St. Jude Medical cannot be guaranteed to perform as intended. These components have been tested to meet safety requirements:

■ EnSite Precision™ Display WorkStation (DWS)

■ EnSite™ Amplifier

■ Hospital grade power cord

■ RecordConnect

■ GenConnect

■ CathLink™ Module

■ ArrayLink™ Module

■ NavLink™ Module

■ SJM ECG Cable

■ EnSite™ Array™ Catheter

■ Fiber optic cable

■ EnSite Precision™ Module, Sensor Enabled™

■ EnSite Precision™ Surface Electrode Kit

21EnSite Precision™ Cardiac Mapping System Instructions for UseARTEN100141615 Rev.A

State: Released Date: 2016.01.12 15:46 GMT

Technical Specifications

Specifications

Table 1. EnSite™ Amplifier Specifications

Safety

Classification Class IIAmplifier 100014514

Leakage Conforms with IEC 60601-1

Defibrillator Protection

Conforms to IEC 60601-2-27Type CF, Type BFDefibrillator-proof applied parts

Isolation > 4000 volts; > 5000 volts surge

Protection against the ingress of water

IPX0

Input from patient

ECG 12 lead

Catheter 2 mm patient-safe jacks

EnSite™ Array™

Custom assembly

EnSite™ NavX™ Navigation and Visualization Technology Electrodes

Custom assembly

Recording System

Custom assembly

Input from other equipment

Ablation generator

Custom assemblies

Table 2. Signal Processing Specifications

Sampling rate 2kHz nominal

Resolution 24 bits

Gain accuracy ± 2%

Input signal DC offset

± 1500 mV

Input amplitude accuracy

Absolute 10%; channel to channel 5%

EnGuide signal 8.138 kHz signal to up to four EP catheter electrodes

Table 3. Display Workstation (DWS) Specifications

Workstation Multi core CPU PC, PCI Express graphics, and DVD/CD writer

Display monitor Refer to the product literature provided with the monitor for connector characteristics.

Table 4. EnSite™ Precision™ Link, Sensor Enabled™ Specifications

Safety

Classification Class II

Leakage Conforms to IEC 60601-1

Defibrillator Protection

Conforms to IEC 60601-1Type CF, Type BFDefibrillator-proof applied parts

Isolation Conforms to IEC 60601-1

Protection against the ingress of water

IPX1

Table 5. Software Specifications

Operating system

Linux

22 EnSite Precision™ Cardiac Mapping System Instructions for UseARTEN100141615 Rev.A


Mapping system

St. Jude Medical proprietary software

Table 6. AC/MAINS Power Input Specifications

Input voltage 100, 110/120, 220/240 V 50/60 Hz

Power inputs (nominal)

DWS components

450 W maximum

EnSite™ Amplifier

400 W maximum

Mode of operation

Continuous

Table 7. Environmental Conditions

Operating +18 to +27 °C to 90% relative humidity, non-condensing

Transport/storage

-25 to +55 °C to 90% relative humidity, non-condensing

EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit –Storage Conditions

-10°C to 40°C

EnSite™ Module Hardware Operating

• Temperature: +18°C to +27°C;• Relative Humidity: 30% to 75% (non-

condensing);• Altitude: up to 3000 m.

EnSite™ Module Hardware Storage

• Temperature: -10°C to +50°C;• Relative Humidity: 20% to 90% (non-

condensing);• Altitude: up to 5574 m.

Table 8. System Component Physical Characteristics (Models Z600 [DWS5] & Z600 [DWS5.1])

Component Dimension in cm (nominal)

Weight in kg (lb)

EnSite™ Amplifier 49 H, 46 W, 51 D 31 (68)

EnSite™ Amplifier cart

94 H, 62 W, 58 D 42 (92)

EnSite Precision™ Cardiac Mapping System Workstation computer

17.45” (442.9mm) H6.75” (171.45mm) W18.3” (464.8mm) D

15 (33)

EnSite Precision™ Cardiac Mapping System Workstation cart

86 H, 63 W, 83 D 41 (90)

Table 3. Software Specifications

EnSite Precision™ Link, Sensor Enabled™

9.9 H, 30.0 W, 21.8 L 5.6 lbs

EnSite Precision™ Field Frame

6.9 H, 55.5 W, 46.0 L 9.9 lbs

EnSite Precision™ Field Frame Bracket

13.8 H, 61.0 W, 53.9 L 4.1 lbs

Table 9. Standards of Compliance

Conforms to ANSI/AAMI STD ES60601-1, IEC STDS 60601-1-1, 60601-1-4 & 60601-1-6Certified to CAN/CSA STD C22.2 NO. 60601-1

Conforms to UL STD 60601-1Certified to CAN/CSA STD C22.2 NO. 601.1

All configurations shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system and is, therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical services department or your local representative.

Table 8. System Component Physical Characteristics (Models Z600 [DWS5] & Z600 [DWS5.1])



Electromagnetic Emissions – Declaration

Table 10. Electromagnetic Emissions Declaration

Declaration – Electromagnetic Emissions

The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the EnSite™ Amplifier / Workstation should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissionsCISPR 11

Group 1 The EnSite™ Amplifier / Workstation uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any

interference in nearby electronic equipment.

RF emissionsCISPR 11

Class A The EnSite™ Amplifier / Workstation is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply

network that supplies buildings used for domestic purposes.

Harmonic emissionsIEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissionsIEC 61000-3-3

Not applicable



Table 11. Electromagnetic Immunity Declaration I

Declaration – Electromagnetic Immunity


Immunity Test IEC 60601Test Level

Compliance Level Electromagnetic Environment –Guidance

Electrostatic discharge (ESD)IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material the relative

humidity should be at least 30%.

Electrical fasttransient/burstIEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV

±1 kV

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

SurgeIEC 61000-4-5

±1 kV differential mode±2 kV common mode

±1 kV

±2 kV

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

Voltage dips, short interruptions and voltage

variations on power supply input lines.

IEC 61000-4-11

<5% UT

>95% dip in UT

for 0.5 cycle

40% UT

60% dip in UT

for 5 cycles

70% UT

30% dip in UT

for 25 cycles

<5% UT

>95% dip in UT

for 5 sec

>95% dip in VNOM for 0.5 line cycle

60% dip in VNOM for 5 line cycles

30% dip in VNOMfor 25 line cycles

>95% of VNOMfor 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of

the EnSite™ Amplifier / Workstation requires continued operation during power mains

interruptions, it is recommended that the EnSite™ Amplifier / Workstation be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)

magnetic fieldIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical

commercial or hospital environment.

Note UT is the a.c. mains voltage prior to application of the test level.



Table 12. Electromagnetic Immunity Declaration II

Declaration – Electromagnetic Immunity


Immunity Test IEC 60601Test Level

ComplianceLevel

Electromagnetic Environment – Guidance

Conducted RFIEC 61000-4-6

Radiated RFIEC 61000-4-3

3 Vrms150kHz to 80 MHz

3 V/m80 MHz to 2.5 GHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the EnSite™ Amplifier / Workstation, including cables, than the recommended

separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation

distance in meters (m)

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EnSite™ Amplifier / Workstation is used exceeds the applicable RF compliance level above, the EnSite™ Amplifier / Workstation should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the EnSite™ Amplifier / Workstation.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m.

V1 3=

E1 3=

d3.5V1------- P=

d3.5E1------- P=

d7

E1------- P=



Table 13. Separation Distances

Recommended separation distances betweenportable and mobile RF communications equipment and the

EnSite™ Amplifier / Workstation

The EnSite™ Amplifier / Workstation are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EnSite™ Amplifier / Workstation can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the EnSite™ Amplifier / Workstation as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitterm

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 .117 .117 .233

.10 .369 .369 .737

1 1.167 1.167 2.33

10 3.69 3.69 7.37

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

d3.5V1------- P= d

3.5E1------- P= d

7E1------- P=

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