Insightec Exablate 4000 Manuale utente

PUB41005213 Rev 1.0

Exablate 4000

Checklists Handbook

For Type 1.1 Systems

SW version 7.33 Running on GE MRIs

WARNING:

This document constitutes a shortened reference manual. It does not

replace the Operator Manual. Adhere to all warnings and precautions as

detailed in the Exablate 4000 type 1.0 & 1.1 SW 7. 33 Operator Manual

For Technical Support contact INSIGHTEC at +1-866-674-3874 (US Number)

PUB41005213 Rev 1.0

Exablate Model 4000, Type 1.1 Transcranial MR guided focused ultrasound system (“Exablate Neuro”, Software

Version 7.33), processing software, and its related documentation are the confidential proprietary property of

INSIGHTEC. Only licensees of INSIGHTEC (“INSIGHTEC”) have the right to use the information contained herein. Only

licensees specifically granted copy and/or transfer rights have the right to copy and/or transfer this information. Any

unauthorized use, disclosure, assignment, transfer or reproduction of this confidential information will be prosecuted

to the full extent of the law.

INSIGHTEC shall not be liable nor obliged in any manner in respect to any bodily injury and/or property damage arising

from the use of this software if such use is not in strict compliance with the instructions and safety precautions

contained in the relevant operating manuals, including all supplements thereto, in all product labels and according to

the terms of warranty and sale of this software, nor if any changes unauthorized by INSIGHTEC are made to the

software contained herein.

User-provided programs or protocols are not validated nor warranted by INSIGHTEC. The use of data obtained with

such user provided software or protocols are the sole responsibility of the user.

Users should be aware of the risk of transmission of computer viruses by exchanging files and CDs.

Trademarks of third-party proprietors are the sole property of those proprietors.

Specifications are subject to change without notice and following applicable regulation and laws.

One or more parts of the product may incorporate or be distributed with open source software. Refer to the Copyright

Notice button in the Utilities Screen.

This document is the property of INSIGHTEC Ltd, and contains proprietary and confidential information of INSIGHTEC

Ltd. A nondisclosure agreement between the recipient and INSIGHTEC Ltd. has been executed prior to receipt of this

document. This document is loaned on the express conditions that ne it nor the information contained the

information contained therein shall be disclosed to others without the express consent of INSIGHTEC Ltd. In addition,

the document shall be returned to INSIGHTEC Ltd. upon request with no copies made.

For Technical Support contact INSIGHTEC at +1-866-674-3874 (US Number)

INSIGHTEC website: http://www.insightec.com/

REVISION INFORMATION

This is the Revision 1 release of the Exablate 4000 Type 1.1 Handbook for SW version 7.33, applicable GE MR

systems. Please contact Insightec Marketing Support to determine if this is the most current release.

Each chapter of this manual has a chapter revision level and date at the bottom. This indicates the release level &

date for the individual chapters. Note that when the manual is updated, not all of the chapters are necessarily

updated, so some chapters may have a revision level earlier than the release revision level.

The cover page and this page are all Revision 1.0 with the corresponding chapters of the manual:

Chapter #

Chapter Name

Chapter Revision,

Date

# of Pages

in Chapter

Chapter 1

System Setup Checklist

1.0, 04/21

Chapter 2

Preparation and DQA Checklist

1.0, 04/21

Chapter 3

Treatment Checklist

1.0, 04/21

Chapter 4

Cleaning Procedure Checklist

1.0, 04/21

Chapter 5

TG Calibration Checklist

1.0, 04/21

* - Including blank back pages

PUB41005213 Rev 1.0 Exablate 4000 Type 1.1 SW v7.33 –Checklists Handbook (GE)

TG-CALIB.

CLEAN

TREAT

PREPARE

SET - UP

System Set Up Checklist

NOTE:

The water system will reach its optimal operating conditions within 30 minutes. Take

this into consideration and turn on the system as early as possible before the

treatment, to avoid downtime when the patient arrives.

NOTE:

Multiple flows exist for System setup, consult the flowcharts on the bottom of this

Checklist and select the option most suitable to your workflow and preferences.

If turning on the System prior to connecting the Helmet System cables to the Front

End Unit, press the Operator Stop Sonication Button to re-initialize connections.

Confirm that the MR console was rebooted at the beginning of the day. If not, reboot it.

Connecting the Helmet System Cables to the Front End Unit

Unlock the Storage and Transfer Cart (STC) wheels, and position it near the Front End Unit (FE)

Connect the Water Cable and the two, uniquely labeled, Quick Coupler Cables to the Front End

CAUTION:

Verify that each Quick Coupler connector is connected to its intended labeled

position. The connectors must be gently aligned into place before locking.

Ensure that the water cable is fully coupled, as indicated by a ‘Click’ sound.

System Power On

Turn on the System by pressing the green Power On switch located on the operator’s console.

The Begin Logon notice will appear.

Remove all external media drives and/or CD’s from the console computer.

Press ”Ctrl+Alt+Delete” to access the logon information dialog box.

(Note: Windows® login parameters are case sensitive)

Select "Brain Mid-Frequency" from the application selection screen.

The Exablate disclaimer popup window will open; click “OK”to continue.

Preparing the Water System

Unload the Water Reservoir from The Water Reservoir Compartment in the Front End Unit and

disconnect it via the Quick Release Cable.

Fill the Reservoir up to the marking, Connect and return it to its designated compartment

Use fresh Reverse Osmosis water for DQA and cleaning, Type 2 medical grade water for treatments

Set the water system to “Preparation” either from the Workstation “Utilities” menu ( ) or from

the Water System Control Touchscreen

Degassing will start. The status of the Water System and Dissolved Oxygen (DO) levels [in PPM]) are

indicated on the status bar on the bottom of the Workstation screen and the screen in the FE Unit.

NOTE:

You may proceed with System Set Up while water preparation is ongoing, Degassing

will proceed (unless manually halted) until the operator fills the Transducer

PUB41005213 Rev 1.0 Exablate 4000 Type 1.1 SW v7.33 –Checklists Handbook (GE)

TG-CALIB.

CLEAN

TREAT

PREPARE

SET - UP

Preparing the MR Table

Bring the MR cradle all the way out of the MRI bore

Remove any imaging coils or MRI Baseplates currently connected to the MRI Table

Place the Exablate MR Baseplate on the MR Table and ensure it is fully coupled

Positioning the Helmet System on the MR Table

Unlock the STC's wheels and roll it towards the MR Table while releasing the cables

Place the STC perpendicularly to the MR Table, so that the markings are aligned

Lock the STC’s wheels in place

Release and lower the Coupling Bridge. Ensure full connection between Coupling bridge and MR table.

CAUTION:

To avoid damage to the system components, ensure there is a clear path between the

Helmet System and its designated position on the MR Adapter Baseplate.

Place your hands on the Auxiliary and Main Handles. While pressing the “Transducer Release Button”,

slowly and firmly slide the Helmet System into place. A ‘Clicking’ sound denotes full coupling.

Lower the Main Lock to secure the Helmet System in place

Connect Tracking and Head coil Connector/s to the MRI Table

Connect the Patient Stop Sonication Button cord to the socket on the MRI Table.

Place and\or align Landmark Labels

Unlock the STC wheels and roll it away from the MR table. it will not be needed until after the treatment

Verify System is Ready for Treatment

Confirm that the System and MR status fields are “Ready” on Workstation screen, and the green System

Power Indicator on the operator console is illuminated.

With GE SW version DV26 and up you may need to press the 'External Host' button on the

MR WS and select 'ExAblate' from the drop down menu in order to enable communications.

WARNING:

Visually inspect the Exablate System to:

●Verify the integrity of the Transducer, Front End and MR Table

●Confirm that the connectors are properly fastened

●Confirm that the Exablate MR Baseplate and Helmet System are properly docked

Failure to follow these instructions may result in improper system function.

System Setup Flow Option Charts

CONNECT TO

FRONT END

TURN ON

SYSTEM

PREPARE

WATER

MOUNT HS

ON MR

TABLE

READY

TURN ON

SYSTEM

PREPARE

WATER

MOUNT HS

ON MR TABLE

CONNECT TO

FRONT END

CONNECT TO

FRONT END

MOUNT HS

ON MR

TABLE

PRESS AND

RELEASE

PHYSICIAN STOP

SONICATION

BUTTON

READY

MOUNT HS

ON MR

TABLE

CONNECT TO

FRONT END

TURN ON

SYSTEM

PREPARE

WATER

READY

PUB41005213 Rev 1.0 Exablate 4000 Type 1.1 SW v7.33 –Checklists Handbook (GE)

SET - UP

TG-CALIB.

CLEAN

TREAT

PREPARE

Preparation Checklist

System Set-Up for DQA

Perform one of the System Setup flow options as defined by the System Set Up Checklist

Ensure the Transducer is located in "Home Position", according to label on Positioner

Affix the Patient Membrane intended for the treatment into the DQA Holder Setup

Place a DQA Phantom into DQA Holder Setup, and lock it onto the Helmet System and Transducer

Plug the Head Coil into its dedicated connector (if applicable)

Make sure the transducer’s Air Release Valve is open. Fill transducer with water until slightly convex

Close Air Release Valve. Release excess air from pipes via the Red Excess Air Release button

Perform short mandatory fill to replace lost water. Ensure no leaks. Begin water Circulation

DQA Procedure

On MR scanner console: Register patient

In MR room: Set Landmark and Advance Cradle to scan position

Start a New Treatment from the main menu of the Exablate application software

On MR scanner console: Prescribe and run a 3-Plane Localizer scan

On MR scanner console: Prescribe and run 3 orientations of DQA planning images (Sag, Ax and Cor)

Run Automatic Transducer Tracking scan

On 3T MR: skip TG calibration (select "Cancel")

Perform an MRI central frequency scan (optional)

Open the Image Retrieval Dialog , select and upload the three DQA planning series

Ensure the Transducer Focal Point is located at the center of the DQA phantom

If required: Reposition the transducer & Re-Run a Transducer Tracking scan

Set the Treatment Protocol to Brain-DQA

Press Stop Sonication Button and proceed to Treatment Stage

Set Treatment level to Treat High

NOTE: In the DQA procedure, there is NO need to use CT images or run Movement Detection scans

Sonicate the predefined set of 5 spots using the parameters outlined in the following table

Press Continue to proceed to the next sonication

Use the next sonication button to switch between the predefined spots.

Review results and Adjust Spot Location if it is not in place (>1.5mm from target)

Repeat sonications as needed (after adjust, if images are with artifacts, unclear thermal rise etc.)

Spot #

Orientation

Frequency

Direction

Power

Duration

Goal [Expected Temperature]

Spot Confirmation

Axial

20 W

13 Sec

Geometric alignment

Spot is clearly visible, aligned in RL

Sagittal

20 W

13 Sec

Geometric alignment

Spot is clearly visible, aligned in SI

Axial

30 W

13 Sec

Geometric alignment

Temperature increase

Spot is clearly visible, aligned in AP

Axial

30 W

13 Sec

Steering verification

Steered focus to the correct side

Axial

250W

3 Sec

Cavitation Control

Confirm Active Power Modulation

Quit the treatment and return to entrance screen, drain water from transducer. Set to Degassing

Unplug and dry the Patient Membrane, and stow the DQA Phantom holder setup away

Set the Transducer as Superiorly as possible. Return DQA Phantom to package, mark number of uses.

Prepare table for patient arrival: mattresses (cover with blankets), cushions, warm blankets, etc.

PUB41005213 Rev 1.0 Exablate 4000 Type 1.1 SW v7.33 –Checklists Handbook (GE)

SET - UP

TG-CALIB.

CLEAN

TREAT

PREPARE

Pre-Treatment Preparations

Make sure all necessary INSIGHTEC accessories are available –For one treatment procedure:

Ensure availability of a CT scan (mandatory) and pre-treatment MR (optional)

Prepare Pre-Treatment Plan (with or without pre-treatment MR images)

Perform Daily Quality Assurance (DQA) as outlined in this document

Ensure water system is in active degassing mode, transducer is positioned as superiorly as possible.

Patient Preparation

Confirm patient is shaved and the scalp is cleaned with alcohol.

Ensure IV line is in place

Fit the patient with Compression Stockings [recommended]

Select the appropriate frontal bar (nominal or small) based on the patient's head dimensions

If using the headframe based on INTEGRA UCHRA (Legacy), an optional frontal bar is available

Affix the Head Frame, as inferiorly as possible above the eyebrows

Place the Patient Membrane on the patient’s head, as low as possible, in the right orientation:

Membrane without coil: screw\clasp side down (towards patient's feet)

Membrane with coil: coil connectors towards the patient's feet and neck

Note: If using a single use Membrane it may require cutting to fit the patient

Patient Positioning

Ensure the transducer is placed in the "Home" position (as defined by label on HS)

Bring the patient into the MR suite. Assist patient on Table

Attach Frame to Baseplate and Membrane to Transducer

Plug the Head Coil into its dedicated connector (if applicable)

Fit earplugs and Mirrored Glasses (optional), Cover patient with warming Blankets

Restrain patient’s feet and body with straps and use patient Leg holder if needed

Equip patient with Stop Sonication button

Move Transducer to estimated clinical position. Ensure clearance between patient and Transducer

Fill transducer with water until slightly convex (via Water Control Screen or Remote Controller)

Close Air Release Valve. Release excess air from pipes via the Red Excess Air Release button

Fill additional water to replace lost water. Ensure no leaks. Begin Treatment Circulation

Minimize membrane air folds within transducer’s pass zone

Ensure cables are free to move and advance cradle to scan position

The patient and the Exablate system are now ready for treatment…

INSIGHTEC PATIENT AND TREATMENT ACCESSORIES

DQA Phantom

DQA Holder Setup

Patient Membrane

Assembled Head Frame

Front Bar for Small Heads

Head Frame Positioning Straps

x2 Head Ring Wrench

x4 Disposable Head Frame Screws

x4 Protective Frame Pin Caps

PATIENT MANAGEMENT

Surgical Marker

Razor/shaving tools

Warming Blankets

Ear Plugs

IV Line

Compression Stockings

Blood Pressure/pulse Oxy

Pin Site Anesthesia

PUB41005213 Rev 1.0 Exablate 4000 Type 1.1 SW v7.33 –Checklists Handbook (GE)

PREPARE

SET - UP

TG-CALIB.

CLEAN

TREAT

Treatment Checklist –Planning Stage

on MR scanner console: Register Patient, In MR Room: Set Landmark-center according to labels

on MR scanner console: Prescribe and run a 3-Plane Localizer scan

Run Automatic Transducer Tracking scan

On 3T DV26 (or higher) only: choose to perform or skip TG calibration (See TG-CALIB. Checklist)

Perform an MRI central frequency scan

Select an appropriate Treatment Protocol

Load Pre-Plan if available. Otherwise load CT scan (Pre-op MR is optional)

on MR scanner console: Plan the first orientation\volumetric series on the MR Console

Select 2D or Volumetric scan protocols, according to imaging preference

Take care to place your mid-slice along the AC-PC Plane

Up to 150 Axial\Sagittal\Coronal slices (Non-Volumetric)

Scan Prepared Series (Note: The Step last edited will be the one scanned)

Wait for automatic Movement Detection Reference images acquisition to finish

Choose an image acquisition method and proceed accordingly:

Reformat Mode

Locate and place the AC and PC

Define the Mid-Line

(Parallel to anatomical midline)

Turn Reformat Mode ON

Press to create volume

Fine-tune orientations.

press to create series

Scan by AC-PC

Locate and place the AC and PC

Define the Mid-Line

(Parallel to anatomical midline)

Scan remaining orientations

User may perform targeting during scans

Alternative Method: acquire images via scan prepared series or from Archive

If No Movement Detection Images have been acquired, press to acquire

Run Auto-Registration

adjust manually (If necessary) until satisfactory registration is obtained

Determine target by measurements

→

OR by manual input of AC-PC\RAS coordinates

Check distance between transducer focus and target

If necessary, adjust transducer location and re-run Transducer Tracking scan

If not already part of pre-plan, press the Auto-Sinus & calcification Marking tool

Review the CT images to evaluate sinus and calcification markings

If necessary, add markings using the Polygonal and Spherical NPR tools

Use the Interpolate tool to auto-draw Polygons between marked slices

Mark Membrane Folds on Axial MR series with the Polygonal NPR and Interpolate tools

Confirm Water Temperature<19oCand PPM Level<2.0 (displayed on lower left corner of screen)

Instruct Patient to press Stop Sonication Button. proceed to Treatment Stage

PUB41005213 Rev 1.0 Exablate 4000 Type 1.1 SW v7.33 –Checklists Handbook (GE)

PREPARE

SET - UP

TG-CALIB.

CLEAN

TREAT

Treatment Checklist –Treatment Stage

Verify spot is on target location and Locked

Press to display Transducer Element Map. Press and confirm:

!# Elements ON > 700

!Skull Area > 200cm2

!Skull Score > 0.4 (or according to regional labeling)

Prior to Applying Sonication

Set Sonication Power, Duration and Time

Extension

Set Scan Orientation, Frequency Direction

Confirm Water Temperature<19oC

Confirm PPM Level<2.0

After Every Sonication

Verify spot alignment

Check for Heating outside of treatment area

Update Peak Temperature if necessary

If Background Temperature is inconsistent,

enable Background Elimination

Sonicate and check location of spot along phase direction, keeping sub-lesional target temp.

Verify alignment for every direction. See table for reference:

Sonications #

Validating

Orientations (frequency directions)

Result

Axial(AP) OR Coronal(SI)

Confirmed R\L

Sagittal(SI) OR Axial(RL)

Confirmed A\P

Coronal(RL) OR Sagittal(AP)

Confirmed S\I

If spot is misaligned, use the Geo-Adjust Tool to pinpoint the center of the spot

!Continue to next level only after spot is clearly visible and aligned along ALL orientations

Proceed to verify stage. Accumulated adjustments [mm]: RL: ______ AP: ______ SI: ______.

Gradually increase energies by 10%-25% until reaching temperature of ~50oC

Evaluate Patient before proceeding to “Treat Low”

Gradually increase energies by 10%-25% until achieving effect & permanent lesioning temperatures

If necessary, adjust Target Location

Post-Treatment Procedures

Open the Air Release Valve on top of the Transducer and Drain the water from the Transducer.

Disconnect Head Coil (if applicable), Release and handle the Membrane as defined at the end of the

Cleaning Procedure Checklist, move transducer as superiorly as possible.

Release Head Frame from the Baseplate, take the patient off the Table and Remove the Head frame.

Transfer Helmet System to the Cart. Perform the cleaning as defined by Cleaning Procedure Checklist,

or further detailed in the Cleaning and Disinfection Chapter of the Operator Manual.

After the Cleaning, drain Transducer, discard drained water, and Shut Down System.

Check availability of DQA Phantom and Patient Membrane for next treatment.

PUB41005213Rev 1.0 Exablate 4000 Type 1.0 SW v7.33 –Checklists Handbook

TREAT

PREPARE

SET - UP

B1-CALIB.

CLEAN

Cleaning Procedure Checklist

The Exablate Cleaning Procedure Requires:

•Water Tank Disinfectant - 50 ml Sodium Hypochlorite (CAS # 7681-52-9) 4.00% - 4.99%

•Cleaning & Disinfection Wipes - containing 0.2 - 0.4% of benzalkonium chloride (CAS # 8001-54-5)

Water System Cleaning Procedure

Wipe the patient membrane with dedicated cleaning & Disinfection wipes and allow to dry

Ensure Transducer is empty and all water used during the procedure has been discarded of

Fill the Water System Reservoir (Tank) with ~13 liters of fresh Reverse Osmosis water

Pour Water Tank Disinfectant in the Tank and re-connect it

On the Water System home screen (Figure 1A), press the “Clean” option

The system will switch to Clean Mode (Figure 1B)

(Note: If not at home screen, press the “Home” button )

Fig. 1A: Water System Touchscreen “Home” Menu Fig. 2B: Water System “Clean” Menu – on Hold

Press “Start” button to start the cleaning operation (Figure 2A). A countdown timer on the

WS status bar and water system screen displays the remaining cleaning time of the Tank

Fig. 2A: “Tank Cleaning in Progress” Screen Fig. 2B:–“Cleaning Tank Completed” Screen

Mount Patient Membrane on the DQA holder setup (without a DQA phantom)

Attach the DQA holder setup to the HS and seal the Transducer

A “Cleaning Tank Completed” message (Figure 2B) will appear when the timer reaches zero. The system

is now ready for stage two of the cleaning cycle –Transducer cleaning.

Verify that the Transducer is connected to the water system connector at the Front-End

Fill the Transducer by pressing the “Fill” button on the Screen or on the Water System Remote

Controller. Close the Valve once the Transducer is full.

(Tip: bringing the Transducer to an inferior position reduces the required volume for filling the

Transducer interface, shortening fill and drain times for the transducer cleaning procedure)

Start the “Cleaning Transducer” timer by pressing the “Start” button on the Screen

(Figure 3A) or on the Water System Remote Controller

PUB41005213Rev 1.0 Exablate 4000 Type 1.0 SW v7.33 –Checklists Handbook

TREAT

PREPARE

SET - UP

B1-CALIB.

CLEAN

Fig. 3A: “Cleaning Transducer in Progress” Screen Fig. 3B:“Cleaning Transducer Complete” Screen

When timer is over, the Transducer cleaning is completed (Figure 3B)

Set the Release Valve to air

Drain the water from the Transducer by pressing the “Drain” button on the Screen or on the Water

System Remote Controller

Dispose the water from the Water Tank according to the site and/or local regulations.

Leave the Tank open to air (without the cap)

Replace the phantom holder interface membrane with the protective transducer cover

Turn off the Exablate® Workstation if no more treatments are scheduled for the day

Patient Membrane and DQA Phantom Gel Handling

It is recommended to wear personal protective equipment (i.e. gloves) when handling the accessories.

Multi Use Accessories

WARNING:

Multi-Use Patient Membranes (with/without coil) and DQA Phantom are intended

for limited re-use of up to 5 treatments

Before and after each cleaning cycle , wipe DQA Phantom and the Patient Membrane (inc. coil)

thoroughly with cleaning & disinfection wipes. Pay extra care to the internal edges of the Membrane.

Store the Patient Membrane and DQA Phantom in their original packaging. Mark number of uses.

Discard of membranes, DQA Phantom and their storage box (according to the local/site procedures)

after their fifth use or in case of any visual signs of damage.

Single Use (Legacy) Accessories

Discard of membrane and DQA Phantom Gel and their storage boxes following the conclusion of a

treatment (according to the local/site procedures).

Wiping the Transducer

Before and after each cleaning cycle, clean the internal surface of the Transducer with the cleaning &

disinfection wipes

Do not apply force on the Transducer surface

Following treatment, place the protective cover to cover the Transducer surface

WARNING:

Failing to comply with Patient Membrane and DQA Phantom Gel Handling

instructions may result in reduced imaging quality, water leakage, cross-

contamination, burns, electrocution risk and false/unreliable DQA results

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