RFI 33 - Cryoblation.pdf

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VISUAL-ICE MRI CRYOABLATION SYSTEM

Created for VA Palo Alto September 13, 2022

OVERVIEW

1. Project Background and Description

Procurement of the Visual-ICE MRI Cryoablation System

• Cryoablation is a process that uses extreme cold to destroy or damage tissue

• Treatment delivered by the Cryoablation System and Needles are based on the Joule-Thomson effect in which compressed gases change temperature when the gas expands to a lower pressure

• The Cryoablation Systems controls the gas delivered from cylinders of compressed gas and circulated through closed tip cryoablation needles creating the freezing and thawing

• Each Visual-ICE MRI Cryoablation System cabling is custom designed to your specific facility

• Pre-install is outlined in steps below and must be completed prior to build of the custom system

• Post install- testing and training will be carried out

2. Pre-Installation Scope

There are 5 main steps that need to occur prior to shipping and installation of the Visual-ICE MRI Cryoablation System to make sure the suite is ready to accept the Visual-ICE Cryoablation System.

Group meeting to understand floor plan and layout

Purchase order is received for capital acquisition

On-site meeting to finalize location for junction boxes and measure for cable lengths (see appendix A)

Facility signs off on document containing measurements and floor plan

Facility build-out of blank plate (filter plate)

3. Facility Build Out Requirements

Accessible outlet in control room within 6 feet of the suggested console location during cases

• ELECTRICAL SPECIFICATIONS

• Input Voltage: 100 to 240 VAC, single phase

• Input Frequency: 50-60Hz

• VA Rating: 450 VA

• IP Rating: IP10

• Fuse Rating: T 5.0A

VHAPALGargM Text Box

ATTACHMENT D

Penetration (Filter) Plate hole to be cut, threaded, and installed by customer facility/contractor – (if drywall cavity is required, i.e. - not able to utilize existing MRI penetration panel for pass through, a filter plate frame (wall frame that will accept Visual-ICE system filter plate to be mounted with threaded mounting holes matching filter plate penetration to accept filter plate, blank plate and template is provided during site visit

• Footprint of plate: 8 in x 6 in

• Note: about 12” of clearance is needed from the front of the Penetration Panel to allow space for gas, electrical and fiber optics connections and 2-3 in at top and sides for clearance and connections

2 1/2in-3in holes in wall for junction box cable conduit runs at each junction box location above or below junction box

• Will be determined at site visit

Tank storage location mounts if applicable, (some sites have tanks brought in on carts for cases and do not keep them in control room)

• Based on feedback from the pre-call gas will be brought in on carts at this facility

If Visual-ICE MRI cabling to Visual-ICE MRI from junction box will remain in place, facility should install cable hooks (this method ensures cable connections at junction box remain fastened. Same can hold true for MRI suite if applicable.

• Based on feedback on the pre-call this system will be stored when not in use

4. Delivery of System

The system will ship in 3 containers and will ship via freight company

1 crate- Mobile Connection Panel

1 crate- Console

1 box- with cabling, junction boxes, penetration panel with connections

5. Installation

Installation is performed by a Boston Scientific Field Engineer that has been trained and has experience in installing into a MR Suite. Installation and testing will take approximately 4-6 hours.

Facilities individuals on site during installation:

Physicist or Technician to perform a pre-scan using phantom once all hospital facility/contractor pre-work has been completed (a post scan will be required after installation of Visual-ICE MRI system to verify no artifact present)

Facilities representative, in case of questions

During installation, a tank of Helium and Argon gas should also be present for testing (see gas requirements below)

6. Gas Requirements

Gas is required during testing at time install and for all procedures.

Both Argon and Helium gas is required with the use of the Visual-ICE MRI Cryoablation System

7. High-Level Timeline/Schedule

Timeline for a custom-built Visual-ICE MRI system is 20 weeks. This timeline starts following facility sign-off site plan.

NEXT STEPS

Next steps to proceed with this project:

Activity Responsible Party Date

Boston Scientific to receive PO VA Palo Alto

Site visit by Boston Scientific Field Engineer

BSC to coordinate with Facility

Site Visit- the following individuals should be present from the facility during site visit:

MR Tech

All parties

Boston Scientific will provide blank plate

Physician

Physicist

Facilities during this visit

Sign-off of site plan created by Boston Scientific

VA Palo Alto

Start custom cable build and system build

Up to 20 weeks

Boston Scientific

VA Palo Alto to complete build out and placement of blank plate

VA Palo Alto

Facility and Boston Scientific check-in

2 weeks prior to shipping

Both parties

Shipping of Visual-ICE MRI Cryoablation System

Boston Scientific

Schedule and complete installation

Installation can be performed after hours if needed to avoid scheduling conflicts during the day

Both parties

Appendix A

Garg, Mohit

From: Reilly, Jennifer <Jennifer.Reilly@bsci.com>

Sent: Thursday, September 22, 2022 9:01 AM

To: Garg, Mohit; Kerkvliet, Julie

Subject: [EXTERNAL] Re: MRI Overview and Specifications

Hello Mohit, I hope this finds you well. Just wanted to let you know we had a conference call on Tuesday confirming the cryoablation system price increase in 2023. If we get the PO in before January 1, 2023 we can lock in your price. Like

Julie mentioned, just because we have a PO# doesn’t mean we need to install right away. We just want to ensure you get the best price.

Thank you, Jen

Jen Reilly

Interventional Oncology Consultant

(559) 801-5652 jennifer.reilly@bsci.com

From: Garg, Mohit <Mohit.Garg@va.gov>

Sent: Wednesday, September 14, 2022 10:52:54 AM

To: Kerkvliet, Julie <Julie.Kerkvliet@bsci.com>

Cc: Reilly, Jennifer <Jennifer.Reilly@bsci.com>

Subject: {External} RE: MRI Overview and Specifications

Thank you very much for the clear and concise scope of work document!

From: Kerkvliet, Julie <Julie.Kerkvliet@bsci.com>

Sent: Wednesday, September 14, 2022 4:56 AM

To: Garg, Mohit <Mohit.Garg@va.gov>

Cc: Reilly, Jennifer <Jennifer.Reilly@bsci.com>

Subject: [EXTERNAL] RE: MRI Overview and Specifications

Thank you for your well wishes, it will be a long road, but all will be good.

Please see the attached scope and please let me know if you have questions.

I did ask another facility the time and costs it took to do the build out of the panel at there site and they responded the following, “…once we knew where we wanted the plate to be placed and verified nothing was in the wall it took labor about 2 hours to complete. I do not have exact costs for this plate construction as we had other work being performed at the same time.” I can keep digging if you need costs estimates.

All the best, Julie

VHAPALGargM Highlight If we get the PO in before January 1, 2023 we can lock in your price.

MRI Components and Specifications

For planning purposes: The facility will need a 6in x 8in space available in the penetration panel.

Mobile Connection Panel (MCP)

• MR compatible- sits next to the scanner

• This is what the MR compatible needles will connect to in order to perform the treatment

• From the back of the MCP will be a Harness (3 connected cables) this will connect to the Junction Box in the room

• No electrical plug in is required

Harness

This is MR compatible and this is a connection for gas, electrical and fiber optics to flow

• from the MCP in the MR room to the Junction Box and

• from the Console in the Control Room to the Control Room Junction Box

Junction Box

There are 2 Junction Boxes one that sits on a wall mounted in the MR Room and one that is in the Control Room

• Location of these will be decided during BSC site visit- these will be strategically placed

• Junction Boxes will be installed by a BSC Technical Service Rep during full install of the system

• Extending from the Junction Boxes out the front will be the opposite end of the Harness Connection

• From the top or bottom of the box another set of cables will be attached- this will flow thru a 3in hole and connect to the penetration panel.

o The 3in hole will be drilled on site during install

Penetration Panel

This is the main connection for all connections. This space will need to be identified in current panel or a new panel will need to be created. This panel work is all done by the facility.

• Upon receipt of a PO a blank panel will be provided to prep the space for install

• During install from a BSC Technical Services Rep he will remove the blank panel and install the working

Penetration Panel

• Panel space needed- 6in tall x 8in wide

• Physicist and team will run measurement testing both pre and post install

Console

Is not MR compatible- sits in the Control Room

• Requires a basic electrical connection

• Input Voltage: 100 to 240 VAC, single phase

• Input Frequency: 50-60Hz

• VA Rating: 450 VA

• IP Rating: IP10

• Fuse Rating: T 5.0A

• The front of the Console will connect to the Harness

• The back of the Console will connect to Argon and Helium gas lines which will then run to tanks (see below for specifications)

Gas

Argon and Helium High Pressured Gas is required to run the needles

• Gas will be needed for every case and depending on treatment multiple tanks will be required

Best, Jen Reilly

Interventional Oncology Consultant

C: (559) 801-5652

E: jennifer.reilly@bsci.com

Boston Scientific https://www.bostonscientific.com/en-US/Home.html