CAE CathLabVR Simulator User manual

User Guide

Front Matter
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PN: 905K400652
END USER LICENSE AGREEMENT
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The software you are about to access is provided to you pursuant to the purchase of the Product by
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reproduced by the Licensee.

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2. License
2.1 In consideration of Licensee’s agreement and compliance with the terms and conditions
contained in the HEPGTC and in this License, CAE grants to Licensee a personal, non-exclusive, non-
transferable license to use the Software and Data exclusively with the Product, and with the device on
which this License appears.
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that any Authorized Users:
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only CAE shall have the right to alter, maintain, enhance or otherwise modify the Software.
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or derive the source code related thereto;
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e. not use the Product without the key, if provided with the Product, or attempt to develop
or develop any means or technology which would enable Licensee to bypass the use of
the key to operate the Product;
f. prevent anyone other than Authorized Users from accessing or using the Product;
g. not incorporate the Product, in whole or in part, to any product or service that Licensee
would make available to a third party, on a commercial basis or not.
2.4 Notwithstanding anything else contained in this License, in no event shall Licensee use the
Product and/or Confidential Information to enable, support, or otherwise aid Licensee or a third
party to develop any product, software or service competitive with any of CAE’s products.
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usage of the Product to verify Licensee’s compliance with this Agreement, as well as to control access
to the Software through use of license administration software.
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exclusive property of CAE. Licensee shall not modify such Work in any way whatsoever and shall not
remove or alter any CAE notices. However, Licensee is permitted to produce and reproduce such
Work only for non-commercial educational purposes.

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3. Consent to Use of Collection Data and Feedback
3.1 Licensee agrees that CAE may collect and use technical data and related information, times
(“Collection Data”), including but not limited to technical information about your Product that is
gathered periodically to facilitate the provision of Software updates, Product support and other
services related to your Product such as Software feature usage and run times. Such Collected Data
shall be anonymous, and shall not personally identify any individual users. In the event that Licensee
wishes to opt-out of permitting CAE from having access to Collected Data, Licensee must inform CAE
of this requirement..
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suggestions, data, information or feedback (“Feedback”) on the Product.
3.3 Licensee acknowledges and agrees that such Feedback and Collected Data may be freely used by
CAE, at its sole discretion, for the design, development, improvement, marketing and
commercialization of its products and services, without any restrictions based on confidentiality or
intellectual property rights.
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remain in effect until terminated as provided hereafter.
4.2 This License terminates immediately upon termination of the HEPGTC.
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use the Software otherwise than as authorized herein, or (d) is otherwise in breach of its obligations
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comply with any other terms and conditions of this Agreement and such failure is not cured within
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disclosure and limited to the purpose requested, with prior notice to CAE to permit it to seek an
appropriate remedy to prevent the disclosure, or alternatively to agree to the terms of such
disclosure.

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5.2 The obligations of confidentiality, use and non-disclosure referred to in this Section 5 shall not
apply to information which: (i) is or becomes publicly available through no fault of Licensee; (ii) was
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obtained by Licensee in good faith and on a non-confidential basis and without a use restriction from
a third party who lawfully obtained and disclosed such information. However, Confidential
Information does not come within the foregoing exceptions merely because features of it may be
found separately or within a general disclosure in the public domain.
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action, legal or otherwise, to the extent necessary to cause anyone having access to the Confidential
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than reasonable care). Licensee shall be responsible and indemnify, defend and hold harmless CAE
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a breach.
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7.1 THE SOLE WARRANTIES PROVIDED BY CAE ARE LIMITED TO THE WARRANTIES PROVIDED IN THE
HEPGTC. ANY WARRANTIES PROVIDED ARE PERSONAL AND NOT TRANSFERABLE.
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8.1 CAE’S LIABILITY SHALL IN NO CIRCUMSTANCES EXCEED THE LIMITATION OF LIABILITY INDICATED
IN THE HEPGTC.
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BUSINESS, OR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OF
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NO EVENT WILL CAE’S LIABILITY TO LICENSEE FOR ANY CLAIM, WHETHER IN CONTRACT, TORT OR ANY
OTHER THEORY OF LIABILITY, EXCEED THE PURCHASE PRICE OF THE PRODUCT PAID BY LICENSEE.

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9. Third-Party Software
9.1 The Software may come bundled or otherwise be distributed with open source or other third
party software, which is subject to the terms and conditions of the specific license under which it is
distributed. OPEN SOURCE SOFTWARE IS PROVIDED BY CAE "AS IS" WITHOUT ANY WARRANTY,
EXPRESS, IMPLIED, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTY OF
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CLAIMS ARISING OUT OF OR IN CONNECTION WITH OPEN SOURCE SOFTWARE, DELL SHALL HAVE NO
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DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT
LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE
OF OPEN SOURCE SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
10. Administrative Positions
10.1 Applicable Law and Jurisdiction: This License shall be governed by, subject to, and interpreted
according to the laws of the State of Florida, U. S. A., without regard to its conflict of law rules. In all
cases, the Parties expressly exclude and waive the application of the United Nations Convention on
Commercial Agreements for the International Sale of Goods (1980) (Vienna Sales Convention) as
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or seek dismissal of the action on the basis of forum non-conveniens. EACH PARTY HERETO
IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL
RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS
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10.2 United States Government Licensee: If Licensee is the United States Government (“U.S.
Government”) or a unit or agency of the U.S. Government, the Software and Data are deemed to be
“commercial computer software” and “commercial computer software documentation”, respectively,
pursuant to DFAR Section 227.7202 and FAR Section 12.212 b) as applicable. Any use, modification,
reproduction, release, performance, display, or disclosure of the Software and/or Data by the U. S.
Government, or any of its units or agencies shall be governed solely by the terms of this License and
the HEPGTC. Any technical data provided by CAE with the Product that is not covered by the above
provisions is deemed to be "technical data-commercial items" pursuant to DFAR Section
252.227.7015(a).
10.3 Export Controls: Licensee acknowledges that the laws and regulations of the United States may
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the Software. Licensee agrees that it will not export or re-export Software of, or containing items of,
United States origin, in any form, without the appropriate United States and foreign governmental
licenses.

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10.4 Excluded Data: Licensee acknowledges that Software provided under this License are not
designed with security and access management for the processing and/or storage of the following
categories of data: (1) data that is classified and or used on the U.S. Munitions list, including software
and technical data; (2) articles, services and related technical data designated as defense articles and
defense services; (3) ITAR (International Traffic in Arms Regulations) related data; and (4) other
personally identifiable information that is subject to heightened security requirements as a result of
Licensee's internal policies or practices or by law (collectively referred to as “Excluded Data”).
Licensee hereby agrees that Licensee is solely responsible for reviewing its data that will be provided
to CAE (or to which CAE will have access) to ensure that it does not contain Excluded Data.
10.5 No Waiver: No omission or delay by either party at any time to enforce a right or remedy
reserved to it or to require performance of any of the terms of this License at the times designated,
shall be a waiver of such right or remedy to which the party is entitled, nor shall it in any way affect
the right of the party to subsequently enforce such provisions.
10.6 Modification: No provision of this License shall be deemed waived, amended or modified by
either party unless the waiver, amendment or modification is in writing and signed by each of the
parties to this License.
10.7 Severity: If any one or more of the provisions of this License is for any reason held invalid, illegal
or unenforceable, the remaining provisions of this Agreement will be unimpaired.
End of End User License Agreement

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SYSTEM SPECIFICATIONS
Note: For upgrade instructions and Embedtek computer Specifications, refer to Appendix C.
Device
Dimensions 69.5” W x 9.8” D x 8.9” H
176.5cm W x 24.9cm D x 22.7cm H
Weight 45 lbs (20.9 kg)
Electrical 24 V DC, 3A (72W max)
Environmental
Conditions
Operating temperature: 50° to 90° F (10° to 32° C)
Relative Humidity: 20 to 80%
Storage Conditions Non-Operating temperature: -40° to -149° F (-40° to 65° C)
Relative Humidity: 20 to 80%
Cart
Dimensions 95.6” W x 60.6” D x 71.6” H
2429cm W x 154cm D x 181.9cm H
Weight 250 lbs (113 kg)
Computer (HP Z620)
Dimensions 17.5” H x 6.75” W x 18.3” D
44.45cm H x 17.15cm W x 46.48cm D
Weight 49.9 lbs (22.6kg)
Electrical 100 to 240 VAC
Environmen-
tal Condi-
tions
Operating temperature: 40° to 95° F (5° to 35° C)
Relative humidity: 8 to 85%
Storage Conditions Non-operating temperature: -40° to -140° F (-40° to 60° C)
Relative humidity: 8 to 90%

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CAECathLabVR
CAUTIONS AND WARNINGS
Please read and understand these cautions and warnings before you begin using the simulator.
• Keep all electronic equipment free from high humidity or liquids
• Avoid weighing down the equipment with any tools or accessories not relevant to the
immediately exercise
• Do not operate your equipment with any covers removed
• Do not use your equipment in a wet environment. Protect equipment for liquid intrusion
• Do not put any object on top of the bottom platform. Movement of the lift mechanism
can cause crush hazard, resulting in possible bodily injuries and damaged equipment.
• Do not jam the motor lift mechanism onto an object. This is a misuse and subjects the
motor to burn out. It can also result in possible bodily injuries and damaged equipment.
• Tip-over hazard: Do not move your equipment without fully lowering the lift mechanism.
Failure to do so can result in possible bodily injury and damaged equipment.
• Improper or prolonged keyboard use may results in injury
• Viewing a monitor screen for extended period of time may result in eye strain
• Ensure that the equipment relies on circuit protection in the building supple
• Install equipment near an electric socket. Ensure cables do not represent a hazard

Table of Contents
1
End User License Agreement For CAE Products .................................... i
System Specifications ............................................................................. vii
Cautions and Warnings ......................................................................... viii
Introduction............................................................................................... 1
Contained in this User Guide .......................................................................2
Equipment Overview ................................................................................ 3
CathLabVR Simulator ....................................................................................4
Anatomy Plate................................................................................................4
CathLabVR Computer....................................................................................4
CathLabVR Cart ..............................................................................................5
Monitor Pole...................................................................................................5
Extension Tray................................................................................................5
CathLabVR Shelf.............................................................................................5
Control Box.....................................................................................................5
Keyboard and Mouse....................................................................................5
Monitors .........................................................................................................6
Monitor Power Cable ....................................................................................6
Monitor DVI Cables........................................................................................6
Foot Pedals .....................................................................................................6
Accessories .....................................................................................................6
Embolic Protection Tool Kit ..........................................................................7
CRDM Tool Kit ................................................................................................7
Vascular Tool Kit....................................................................................... 8
Before Using the Simulator ..........................................................................8
Using the Simulator .................................................................................. 9
Starting the Software ..................................................................................10
Interface Overview.................................................................................12
Selecting a Simulation.................................................................................15
Reviewing the Didactic Content............................................................18
Training Objectives......................................................................................19
Running a Simulation..................................................................................24

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2
Using the Simulation Tips .....................................................................27
Selecting a Tool ......................................................................................28
Inserting a Tool.......................................................................................30
Removing a Tool.....................................................................................32
Using the Pedals.....................................................................................33
Calibrating the Measurement Feature ................................................35
Using the Control Box............................................................................36
Using the Contrast Syringe ...................................................................37
Using the Physio Feature ......................................................................39
Using the Roadmapping Feature .........................................................40
Customizing a Wire or Stylet.................................................................41
Fixating an Active-Fixation Lead...........................................................43
Using the Venogram Balloon................................................................44
Using the Balloon Inflation Feature .....................................................45
Using the Embolic Protection Devices.................................................47
Using the Adjunct Therapy Feature .....................................................48
Using the Analyzer Function .................................................................49
Accessing the Cine Gallery ....................................................................50
Accessing the Stills Gallery....................................................................51
Ending a Simulation.....................................................................................51
Viewing Results ............................................................................................52
Viewing Personal Data...........................................................................53
Viewing Usage Summaries .........................................................................54
Viewing Reports ...........................................................................................55
Printing Data from the Simulator ..............................................................58
Printing Data to a Network Printer ......................................................58
Printing Data to a PDF File ....................................................................60
Modifying Language Preferences ..............................................................62
Adjusting the Volume..................................................................................63
Hiding the Available Tasks Panel ...............................................................63
Exiting the Software ....................................................................................64
Frequently Asked Questions..................................................................65

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Software Questions.....................................................................................65
Module Instruments and Required Equipment.......................................72
Cardiac Rhythm Disease Management (CRDM) .................................72
Cardiac Surgery ......................................................................................72
Percutaneous Coronary Interventions (PCI) .......................................73
Percutaneous Peripheral Interventions (PPI) .....................................74
Appendix B - Keyboard Shortcuts.........................................................75
Introduction.............................................................................................76
Contained in this User Guide .....................................................................77
Appendix C - ............................................................................................79
Upgrade Instructions and Embedtek Computer Specifications........79
Medtronic CathLab VR™ Upgrade instructions........................................79

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Introduction
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INTRODUCTION
This CathLabVRTM Simulator User Guide provides information about setting up the simulator,
navigating the user interface, and maintaining the system.
The CathLabVR System allows physicians, nurses and technicians to practice endovascular diagnostic
and intervention procedures in a highly realistic, reproducible and safe training environment.
Trainees can navigate realistically modified endovascular tools through a virtual anatomy based on
actual patient data. 3-D graphics, auditory and state-of-the-art haptic feedback enhance the virtual
reality.
IMPORTANT: The CathLabVR Simulator is a training tool. The simulator is not intended to diagnose
the condition of a live human being or identify a life-threatening situation. The CathVR Simulator is
one of a series of didactic tools that can be used to improve training for endovascular diagnostic and
intervention procedures. This simulator is not intended to replace any courses or hands-on sessions
with live subjects, but should be implemented as part of a blended learning solution.
The CathLabVR Simulator

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Contained in this User Guide
This User Guide has been designed for quick access to information on how to use and maintain the
CathLabVR Simulator. Please be sure to read and follow the Cautions and Warnings on the pages
preceding the Table of Contents. This is for the safety of users as well as for the protection of the
simulator.
The Equipment Overview outlines the items that come standard with the purchase of a CathLabVR
base unit.
The Using the Simulator section provides instructions on the use of the various tools and hardware
features integrated into the simulated experience. This section also includes information on how the
simulator and software components work and the functionality that each supports. Various surgical
procedures are explained, along with how these procedures isolate critically important learning
objectives.
The Frequently Asked Questions section addresses some of the more common troubleshooting
concerns.
The Module Descriptions appendix outlines the specific tools and accessories that should be used
in each of the procedures for the CathLabVR.
The Keyboard Shortcuts appendix describes the shortcut keys and their functions for the
CathLabVR.

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EQUIPMENT OVERVIEW
The CathLabVRTM Simulator comes standard with the necessary equipment and accessories for using
the base unit.
Note: As you would with any shipment, check the inventory against the packing invoice to verify that
all components have been received.
Standard Equipment
CathLabVR Simulator
Anatomy Plate
CathLabVR Computer
CathLabVR Cart
Monitor Pole
Extension Tray
Shelf
Control Box
Keyboard and Mouse
Monitors (2)
Monitor Power Cable
DVI Monitor Cables (2)
Dual Foot Pedals
Accessories

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CathLabVR Simulator
The CathLabVR simulator is one of the main hardware components for the CathLabVR unit. All
accessories for the endovascular modules are connected or inserted into the simulator to display the
tool on-screen during a procedure. The carriages inside the simulator correspond with the specific
tools for each individual procedure and require proper care to ensure the product remains in good
working condition.
The CathLabVR Simulator
Anatomy Plate
The CathLabVR anatomy plate is a flesh-tone plastic covering that hooks onto the CathLabVR manikin
and serves as the insertion point for the catheter and wire accessories.
The Anatomy Plate
CathLabVR Computer
The CathLabVR computer is a desktop workstation. The workstation runs on a Windows platform and
supports communication between the CathLabVR software and the CathLabVR manikin.

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CathLabVR Cart
The CathLabVR cart is the structure upon which the CathLabVR manikin, computer and shelves is
secured. The monitor pole is attached to the back of the cart and the computer is stored inside the
cart. The manikin, shelf and trays attach to the top of the cart.
Monitor Pole
The monitor pole attaches to the cart structure and contains a monitor arm for mounting the two flat
screen monitors.
Extension Tray
The extension tray attaches to the main cart structure and serves as a resting place for accessories
prior to use or insertion.
CathLabVR Shelf
The CathLabVR contains a shelf upon which the Control Box is placed.
Control Box
The control box connects to the computer and controls the C-Arm movements, table movements,
zoom and x-ray shutters.
The Control Box
Keyboard and Mouse
The keyboard and mouse connect to the computer and allow users to navigate through the software
and enter information as necessary.
The Zoom
button
The C-Arm
joystick
The Crop
Horizontal
toggle
The Home
button
The Table
joystick
The Crop
Vertical
toggle
The Table Up
button
The Table
Down button

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Monitors
The CathLabVR comes standard with two flat screen monitors. This dual monitor setup allows users
to view their progress and different functions during the simulation with efficiency and accuracy.
Monitor Power Cable
The CathLabVR contains one monitor power cable with two female receptors, each connecting to a
separate monitor.
Monitor DVI Cables
The CathLabVR includes two monitor DVI cables which connect the monitors to the computer.
Foot Pedals
The dual foot pedals connect directly to the back of the manikin and serve as a necessary tool for
completing most simulations on the CathLabVR. The Cine (pronounced “sin-nee”) pedal captures
video clips of actions being performed during a procedure. The Fluro pedal controls the distribution
of x-ray from the C-Arm during a procedure.
Note: In all procedures of the CRDM module, the Fluoro feature is activated by the RIGHT pedal and
the Cine feature is activated by the LEFT pedal.
The Foot Pedals
Accessories
The CathLabVR base unit comes with three tool kits of accessories: the Embolic Protection Tool Kit,
Vascular Tool Kit and the CRDM Tool Kit. The accessories are provided for use in the different learning
modules.

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Embolic Protection Tool Kit
The Embolic Protection Tool Kit contains the following accessories:
• Filter Basket EPD Handle
• Occlusive Ballon EPD Handle
• Self-expanding Stent Handle
• 0.014” Guardwire wire
• Embolectomy aspiration catheter
• Syringe
CRDM Tool Kit
The CRDM Tool Kit contains the following accessories:
• Accessory handles for deflectable catheters (2)
• Guidewire steering handle (torque tool)
• Deflectable (guide) catheters
• 0.035” Diagnostic guidewire
• 0.016” Nitinol guidewire
• Cook introducer valve
• Left heart module, hybrid lead 2187
• 0.016” gray stylet
• Left heart module hyrbid lead 4193
• 55cm Attain (green) catheter
• Modified Attain 6215 venogram balloon catheter
• Venogram balloon syringe
• Inner deflectable catheter
• Left heart module, hybrid lead 4194
• Attain II (outer and inner) subselecting catheters
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