perc mentor manual v2.03 2-2003

Computer ized Tra in ing Simulator for Percutaneous Aceess Punctur ing

Users Manual For the combined PERC Mentor™ & URO Mentor™ simulator

V e r s i o n 2 . 0 3 , F e b r u a r y , 2 0 0 3

Computer Assisted Endoscopy

© Copyright Simbionix 2002. All rights reserved.

The copyright and proprietary rights in the guide belong to Simbionix. It is strictly forbidden to copy, duplicate, sell, lend or otherwise use this guide in any way, shape or form without the prior consent of Simbionix.

This product is based on software developed by Simbionix.

Redistribution and use in source and binary forms are permitted, provided that the above copyright notice and this paragraph are duplicated in all such forms and that any documentation, advertising materials and other materials related to such distribution and use, acknowledge that the software was developed by Simbionix.

THIS SOFTWARE IS PROVIDED “AS IS” AND WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTIBILITY AND FITNESS FOR A PARTICULAR PURPOSE.

All other trademarks used in this document are the property of their respective owners.

Page ii Simbionix PERC Mentor

Contents

Contents................................................................................................................. iii

Simbionix Liability Statement ...............................................................................v

Safety Precautions ............................................................................................... vii

Preface: Introduction to the Simbionix PERC Mentor™ & URO Mentor™ combined simulator ..............................................................................................11

Introduction ..........................................................................................................11

Getting to know the simulator platform .............................................................11 Interchangeable cartridges ..................................................................................12 Changing cartridges ............................................................................................13 Cartridge label ....................................................................................................13 Connecting needles.............................................................................................14

Training and practice opportunities ...................................................................14 Practice Hall .......................................................................................................14 Training program................................................................................................14 Free Training ......................................................................................................15

Chapter 1: PCN Basic Tasks................................................................................17

Practice on basic tasks..........................................................................................17 Tool selection .....................................................................................................20 On-screen instructions in basic tasks ..................................................................21 On screen control panels.....................................................................................22 Additional on-screen information.......................................................................25

Chapter 2: PCN Cases..........................................................................................27 Change patient position ......................................................................................27

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Contents

Practice on virtual patient cases ..........................................................................27 Selecting a case...................................................................................................28 Performing the procedure ...................................................................................29

Index ......................................................................................................................33

Page iv Simbionix PERC Mentor

Simbionix Liability Statement

Simbionix Ltd. ("Simbionix") hereby represents and warrants with regard to the simulator (the "Product") and the software incorporated therein (the "Program") as follows:

Intellectual Property: All intellectual property rights in the Product, the Program, this user manual, and all other written and/or electronic materials that relate to the Product, including any revisions, corrections, modifications, enhancements and/or upgrades thereto (“Documentation”), are Simbionix’s property protected under patents, patent applications, copyright laws and intellectual property treaties. All rights, titles, and interests in and to the Product, the Program, the Documentation and associated property rights (including, without limitation, copyrights, trade secrets, trademarks, etc.), evidenced by or embodied in and/or attached/connected/related to the Product, the Program and the Documentation (including, without limitation, the code), are and shall remain with Simbionix.

Disclaimer: This Product is intended to facilitate training in endoscopy medical procedures. The information and data contained in the Product, the Program, and the Documentation should not be considered complete and should not be used as a substitute for any other method of training and medical education. The Product may only be used for the purpose of simulation and instruction. Nothing contained in the Product, the Program, and the Documentation is intended to be used for medical diagnosis. Information and method of treatment obtained by the use of this Product is not exhaustive and does not cover all diseases, physical condition and method of treatment. The Program is based on general data of the human body; however, it does not represent, and should not be relied upon to represent the characters of any specific human organ.

The Product may only be used by you for the training of medical procedures through the simulation of such procedures. Any other use of the Product is expressly prohibited and any such prohibited action shall automatically terminate the license to use the product.

Simbionix does not warrant that the functions contained in the Product will meet user requirements or that the operation of the Product will be uninterrupted or error free. The entire risk as to the quality and performance of the Product is with the user.

Page v .

Simbionix Liability Statement

Limitation of Liability: Simbionix’s cumulative liability to the user, or any other party for any loss or damages resulting from any claims, demands, or actions arising out of or relating to the Product, shall not exceed the price paid to Simbionix for the Product.

UNDER NO CIRCUMSTANCES AND UNDER NO LEGAL THEORY, TORT, CONTRACT, OR OTHERWISE, SHALL SIMBIONIX OR ITS SUPPLIERS OR RESELLERS OR AGENTS BE LIABLE TO THE USER OR ANY OTHER PERSON FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY TYPE INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF GOODWILL, BUSINESS INTERRUPTION, COMPUTER FAILURE OR MALFUNCTION, LOSS OF BUSINESS PROFITS, LOSS OF BUSINESS INFORMATION, DAMAGES FOR PERSONAL INJURY, INCLUDING ANY KIND OF INJURY RESULTING FROM MEDICAL NEGLIGENCE, OR ANY AND ALL OTHER COMMERCIAL DAMAGES OR LOSSES. IN NO EVENT WILL SIMBIONIX BE LIABLE FOR ANY DAMAGES IN EXCESS OF THE AMOUNT SIMBIONIX RECEIVED FOR THE SIMULATOR, EVEN IF SIMBIONIX MAY HAVE BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGES, OR FOR ANY CLAIM BY ANY OTHER PARTY. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, AS SUCH, THIS LIMITATION AND EXCLUSION MAY NOT APPLY WITH REGARD TO THE LICENSE TO USE THE PRODUCT.

Page vi Simbionix PERC Mentor

Safety Precautions

Before using the PERC Mentor™ simulator, please read these Safety Precautions to ensure the proper use of the equipment. The items for attention displayed here contain important notes to prevent injury to the operator and damage to the equipment.

Two symbols are used to indicate specific types of warnings:

A warning that indicates a prohibition.

A general warning that emphasizes essential information about something that must be done.

The following safety precautions must be adhered to when assembling and using the PERC Mentor™ simulator unit. Failure to follow these precautions could result in the removal of warranty, and may cause irreversible damage to the simulator or injury to operators.

Read all the instructions and precautions fully before attempting to assemble or use the PERC Mentor™.

Follow all warnings and instructions marked on the PERC Mentor™ simulator.

DO NOT use the needles, tools or any other component for anything but the PERC Mentor™. The SIMBIONIX needles and tools are intended for use in simulated medical procedures only.

Use extreme caution when handling the needles! These needles are sharp and may cause injury. In addition, improper usage or dropping of the needle may cause bending and damage to the needle. After use, place the needle back in its storage tube.

When the needles or tools are not in use, make sure that they are placed in their specific locations on the simulator, or stored back in their boxes.

Page vii .

Safety Precautions

Unplug the PERC Mentor™ when you know an electrical storm is approaching. Lightning can pass through the electrical wiring and damage any device connected to it.

Before cleaning, unplug the PERC Mentor™ from the wall outlet, and use a dry cloth, without liquid or aerosol cleaners.

Do not use the PERC Mentor™ near water.

Place the PERC Mentor™ on stable ground only.

To protect the PERC Mentor™ from over heating, the opening on the back of the platform should not be covered or blocked.

The PERC Mentor™ should not be placed near a radiator or heat register.

The PERC Mentor™ should be placed in a room with a temperature range of between 5 and 30 degrees centigrade only. Proper ventilation is crucial.

The PERC Mentor™ should be operated only from the voltage indicated on the marking label; otherwise it may cause a fire or electric shock. If you are not sure of the type of power supply, consult Simbionix support.

Do not allow anything to rest on the power cord.

Do not position the PERC Mentor™ where a cord could be damaged by a person standing on it, or pulling it out accidentally.

Do not overload wall outlets and extension cords, as this could cause a fire or electrical shock.

Never spill liquid of any kind on the simulator.

To reduce the risk of electric shock or voiding of the warranty, do not disassemble or try to repair the PERC Mentor™. Opening or removing parts of the simulator, may cause irreversible damage.

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The PERC Mentor™ must not be modified. Otherwise it may cause a fire, electric shock, a malfunction or irreparable damage.

Avoid placing or dropping anything on the PERC Mentor™. It may cause a malfunction or irreparable damage.

Do not lean on the simulator!

Power must be disconnected when removing cables from the PERC Mentor™. Failure to do this may cause electric shock or injury, a malfunction or irreparable damage.

Handle the computer with caution. Do not attempt to disconnect any wires in the absence of a technician.

Unplug the PERC Mentor™ from the wall outlet and contact Simbionix support under the following conditions:

When any cord, especially the power supply cord, is damaged or frayed.

If liquid has been spilled into the PERC Mentor.

If something has been dropped on the PERC Mentor.

Page ix

Preface:

Introduction to the Simbionix PERC Mentor & URO

Mentor combined simulator

Introduction The PERC MentorTM is an interactive computer assisted medical training simulator designed to provide hands-on training in the field of percutaneous access puncturing done under real-time fluoroscopy. It is designed to meet the needs of specialists in the fields of radiology and urology.

This User’s Manual provides the necessary instructions for working with the PERC Mentor add-on simulator in combination with your URO MentorTM simulator. After installation of the PERC Mentor add-on simulator, the user interface of the URO Mentor will serve the entire combined simulator.

Getting to know the simulator platform Below are drawings of the PERC Mentor simulator as an add-on to the URO Mentor simulator and the interchangeable cartridges that simulate the patient’s back and flank.

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Preface: Introduction to the Simbionix PERC Mentor & URO Mentor combined simulator

Scope & Tool holder

Needle & guide wire storage tubes

Working channels

URO MENTOR PERC MENTOR

Interchangeable cartridge Connector socket for foot pedals and needle cable

Figure 1: Platform of the Combined URO Mentor/PERC Mentor Simulator

INTERCHANGEABLE CARTRIDGES

The puncture pad used for needle puncturing is part of an interchangeable cartridge which simulates a variety of patients. Cartridge 1 for normal weight patients simulates the left kidney while cartridge 2 for obese patients simulates the right kidney.

The puncture pad simulates the virtual patient’s skin and underlying tissues and ribs.

Simbionix PERC Mentor

30° angle Needle cable grip

Pin

B. PERC cartridge oblique position A. PERC cartridge in prone position

Figure 2: Interchangeable Cartridges

CHANGING CARTRIDGES

How to change a cartridge:

1. Grasp the pin on the front of the PCN mannequin and pull out. While the pin is held out, slip your fingers under either the upper or lower edge of the cartridge and pull the cartridge up and out of its carriage.

2. Carefully insert the desired cartridge into the carriage while holding the pin out. Release the pin when the cartridge is in place. Now press the cartridge forward to hear it click into place.

CARTRIDGE LABEL

At the top of the cartridge is a label that gives the cartridge number and patient positioning. The drawing on the label shows a figure lying in the proper direction and position for examination of the appropriate kidney (cartridge 1 – prone left kidney, cartridge 2 –prone right kidney).

Figure 3: Cartridge Labels

Preface: Introduction to the Simbionix PERC Mentor & URO Mentor combined simulator

CONNECTING NEEDLES

The PERC MENTOR includes 2 needles, one 15 cm in length and the other 20 cm in length. These 2 physical needles simulate all of the possible needles of different gauges that may be used in the simulated procedures. In order to make a needle ready for use it must be connected to the needle cable, which is plugged into the socket on the lower part of the simulator platform. (See Figure 1, page 12)

The needle cable passes through a small piece of tubing about ¾ of the way towards the needle. This tubing should be placed in the Needle cable grip (see Figure 2, page 13) after connecting the needle cable.

How to connect a needle to the needle cable:

1. Make sure that the needle cable is plugged into its socket.

2. Take the desired needle and screw it into the fitting at the end of the needle cable.

3. To exchange needles, unscrew the needle from the cable and replace it with the second needle. This changes the needle length. (To change the needle gauge see Tool selection, page 20.)

When using the needles in any procedure, be it Basic Tasks or virtual patient cases, hold the needle by its handle. Prior to puncturing the patient’s skin, take care not to apply pressure on the needle which may cause it to appear on the simulation screen as though it is already inside the patient’s body.

Training and practice opportunities

PRACTICE HALL

The Practice Hall mode on your combined simulator now also provides basic tasks for percutaneous access puncturing. Select and use the PERC Mentor basic tasks in the same fashion that you use those for the URO Mentor.

TRAINING PROGRAM

With the combined PERC Mentor & URO Mentor simulator, a training program may now contain basic tasks and cases from both areas. Select the desired cases and tasks from the entire library of modules available on your combined simulator.


FREE TRAINING

In the Free Training mode you may select any of the virtual patient cases available in the modules on your combined simulator and perform the procedure. You may save your performances in your trainee file.

Chapter 1:

PCN Basic Tasks

Practice on basic tasks This module contains 6 sets of basic tasks for recognition and identification of PCN anatomies and practice in the use of fluoroscopic imaging, C-arm control and manipulation of PCN needles and tools. The module is found by selecting Practice Hall from the main menu (see Begin Work on the Simulator, page 21, in the URO Mentor Users Manual)

You can view the description of each task by placing the cursor over one of the tasks icons (by touching the screen or using the mouse). The description will appear in the lower left corner of the screen.

How to select from the basic tasks:

1. From the main screen of the Practice Hall (see Figure 12: Practice Hall, page 25 in the URO Mentor Users Manual), press on one of the PCN Basic Tasks icons to select it.

A screen will open with written instructions.

2. Read the instructions carefully and then press Start.

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Chapter 1: PCN Basic Tasks

Figure 4: Basic Task Instructions

The PCN Basic Tasks set will load for a number of seconds, and then a screen such as the following will open from which you can start work on the tasks.

Figure 5: Opening Screen in Basic Tasks


Practice on basic tasks

The default needle that is automatically selected is the 15 cm, 18 g needle.

How to begin the tasks:

1. Press OK to close the window.

2. Check to ensure that cartridge 1 is in place. If not, insert it in the cartridge carriage (see Changing cartridges, page 13).

3. Check to see that the 15 cm needle is attached to the needle cable (see Connecting needles, page 14).

4. Press on or click with the mouse on the needle icon on the left side of the screen in order to select an alternative needle.

A menu will open that enables selection of the desired needle length, and from there a submenu will open that enables the selection of the desired needle gauge.

5. Select the desired needle. (See Figure 6: Needle selection menus below)

6. Press on the fluoro pedal or the X-ray button to see the fluoroscopic view.

7. Use the needle to accomplish the exercises set out for you in the basic task you have chosen.

At any time during your practice session you may pause work on the task by pressing on the file icon to the left of the C-arm in order to open the full task file and read the instructions. Closing the file will resume the task.

Figure 6: Needle selection menus


TOOL SELECTION

During the procedure you may find it necessary to use tools, in addition to the needle, such as guide wires or catheters. Tools must be selected from the tools icon menu on the left side of the screen prior to beginning to use them in a procedure.

How to select from the tools menu:

Tools menu

Case file

Figure 7: Tools Icon Menu

1. Press on or click with your left mouse button on the icon from the tools menu on the left side of your screen. A window containing the available choices for that type of tool will open (see example of guide wires below).

2. Select the desired tool from the window menu.

3. Insert the tool into one of the working channels on the PERC MENTOR (see Figure 1 page 12).

In a number of the Basic Tasks the only tool enabled is the needle.



Figure 8: Guide Wire Selection Window

ON-SCREEN INSTRUCTIONS IN BASIC TASKS

In the Basic Tasks you can view on-screen a short summary of the instructions for the specific task you are working on at the moment. A Tasks button for this purpose is located at the top center of the screen.

Figure 9: Open On-screen Instructions for Basic Tasks


How to open on-screen instructions in Basic Tasks:

Press the Tasks button at the top left of the screen and a small window will open containing the instructions (see Figure 9 above). To close the window, press Close.

ON SCREEN CONTROL PANELS

Three on-screen control panels are available during practice on the basic tasks. The first of these is found to the right of the C-arm image and contains the C-arm controls. With these control buttons you can move the fluoroscope arm to obtain the desired fluoroscopic image.

Image Control Panel

C-arm controls

Lower control panel

Figure 10: Control Panels

How to manipulate the C-Arm:

Press on the arrow buttons in the C-Arm Control Panel to manipulate the fluoroscope arm.

Moves the c-arm cranially or caudally



Moves the c-arm forwards and backwards or side to side

Moves the c-arm towards the physician or away from the physician

Returns the c-arm to its default position

The lower control panel (see Figure 10 page 22) contains a number of buttons the operation of which are described below.

Figure 11: Lower Control Panel

How to use the lower control panel:

Press the button in order to:

Open a window providing information on the tools chosen.

To simulate injection of contrast agent through the needle. The accumulated amount of agent injected is indicated beneath the button.

To simulate injection of contrast agent through a ureteral catheter inserted cystopically. The amount of agent injected is indicated beneath the button.

Aspirates fluid through the needle to enable determination of needle location.

The syringe, , will color according to aspirated fluid: yellow indicates urine, red indicates blood and no


change in color indicates no fluid aspirated. The accumulated amount of urine aspirated will be indicated beneath the syringe.

To simulate suspension of ventilation for a period of up to 10 seconds. Before the 10 seconds have lapsed, ventilation can be restarted by pressing the ventilation button again.

A set of buttons on the right side of the screen serve as an image control panel.

How to use the image control panel:

Press on the Image Control button at the top right hand side of the screen to open the image control panel.

Figure 12

The following image control panel will open: Press to close the image control panel

Rotates the image

Flips the image horizontally

Flips the image vertically

Zoom in for image enlargement

Zoom out to reduce overall image size



Displays negative of X-ray image

Toggle between the fluoro image and the 3D image

Return to original settings

ADDITIONAL ON-SCREEN INFORMATION

At the top of the monitor screen information on the selected needle and time statistics are available. (See below)

Info on needle Time statistics

Figure 13: On-screen Information

How to exit Basic Tasks:

1. You may exit the Basic Tasks at any time before or on completion of the task by pressing on the Finish button at the bottom left corner of the screen (see Figure 10, page 22).

2. A window will open asking if you want to save your performance.


Figure 14: Save Performance

3. Select Yes to save the performance in your trainee file and close the task, or No to close without saving the performance. Select Cancel to return to the task.


Chapter 2:

PCN Cases

CHANGE PATIENT POSITION

The simulator default position for PCN procedures is with the patient lying prone. This position can be changed to prone oblique (a 30° tilt) to achieve appropriate access.

How to change patient position to prone oblique:

1. Make sure that the needle is in its storage tube.

2. Pull the pin out on the front of the mannequin to allow the cartridge to move (see Figure 2, page 13).

3. While holding the pin out push the upper part of the cartridge down in its carriage.

4. Release the pin and check that the cartridge is locked in the tilted position. You should be able to feel it click into position.

5. To return patient to the prone position pull the mannequin pin out while pushing on the cartridge handle at the bottom of the cartridge to rotate it back to the original position in its carriage.

Practice on virtual patient cases Virtual patient cases are found under Free Training on the main menu of the simulator or as part of your instructor assigned training program in your trainee file (see Trainee file in URO Mentor manual).

The screen imaging default for virtual patient cases is the fluoroscopic view. The patient default position is prone.

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Chapter 2: PCN Cases SELECTING A CASE

How to begin work on a virtual patient:

1. If you know which type of patient (normal or obese) you will be working on, place the required cartridge in its place (see Changing cartridges, page 13).

The cartridge may be changed at any time prior to actually starting work on the case.

2. In the case selection window use the small arrow buttons on the right side to scroll up or down to view all possible case modules that are active on your simulator.

3. Move the cursor over the desired case. At the bottom of the window the case number and description will appear.

Figure 15: Case selection of PCN modules

4. Press on the desired case or click on it using your left mouse button. The patient’s file will open with the Patient History tab on top.


Practice on virtual patient cases 5. Select the other tabs at the top of the patient file to review lab test results and imaging results.

Figure 16: Patient File - Imaging Results

6. If you have not done so already, change the cartridge to suit your patient type, normal – cartridge 1 or obese – cartridge 2.

7. Press on Start at the bottom right corner of the patient file. The case will begin to load. Loading takes several seconds.

PERFORMING THE PROCEDURE

The default image on the simulator monitor during virtual patient case procedures is the fluoroscopic image. You have the option to toggle the fluoro image to view the procedure in the 3D image view (see the Image Control Panel, page 22).

Chapter 2: PCN Cases

Figure 17: Virtual Patient Procedure in 3D Image View

How to use the C-arm for PCN procedures:

Select the appropriate control arrows in the center of the screen to move the C-arm cranially or caudally, forward towards the patients head or back away from the head or right or left or to rotate the arm towards the physician or away from him (see page 22). Pressing on Reset will return the C-arm to its original position.

How to capture a fluoroscopic image:

1. Select the method for injecting contrast agent (either Antegrade or Retrograde) from the lower control panel on the right side of the screen (see On screen control panels, page 22). Each press on the button will inject 2cc or 5cc of contrast agent depending upon the method chosen.

2. Press on the Fluoro foot pedal or the X-ray button on the lower left side of the screen to achieve an X-ray image. Continuous pressure on the button or pedal will produce a continuous X-ray image. A beeping sound will indicate that X-ray is in use.

How to review the patient file during a procedure:

1. Press or click on the patient file icon on the left side of the screen (see Figure 7, page 20) in order to pause the procedure and review the results.


Practice on virtual patient cases 2. To return to the procedure, press on Close at the bottom of the patient file. The file will close and the procedure will be active.

Index antegrade, 23 aspiration, 23 basic tasks, 17

exit, 25 Basic tasks

select, 17 start, 19 C-arm control panel, 22

cartridges, 12 changing cartridges, 13 connecting needles, 14 control panels, 22 fluoroscopic image

capture, 30 Free Training, 15 image control panel, 24 interchangeable cartridges, 12 lower control panel, 23 needle selection, 19 oblique, 27 On-line instructions

basic tasks, 21 patient file, 30 patient position

oblique, 27 performing procedures, 29 platform, 11 Practice Hall, 14 retrograde, 23 Safety Precautions, vii select a case, 27 tool selection, 20 Tutorials, 14 URO Mentor, 11 ventilation, 24 virtual patient, 27

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perc mentor manual v2.03 2-2003

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