EXHIBIT S - Varian Edge Radiosurgery product Planning Guide.pdf

EDGE RADIOSURGERY

PRODUCT PLANNING GUIDE

PPG-HT-EDGE-B OCTOBER 2023

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EDGE

MANUFACTURER Varian Medical Systems 3100 Hansen Way, Bldg. 4A Palo Alto, CA 94304-1030, U.S.A.

https://www.varian.com

For more information not included in this publication, contact one of the following Varian Regional Planning Departments:

Central, North, and South America: planning.ams@varian.com

Asia Pacific, Australia, India, and China: planning.apac@varian.com

Europe, Middle East, and Africa: planning.emea@varian.com

AUTHORIZED

REPRESENTATIVE

IN THE E.U.

Varian Medical Systems Nederland B.V.

Kokermolen 2 3994 DH Houten The Netherlands

CONVENTIONS All dimension units are shown as Metric (primary) followed by Imperial (secondary).

Metric [Imperial] – The default is cm [inches] unless otherwise noted. Tolerances are given where critical, otherwise, general tolerances from ISO 4463-1: 1989 should be used. The metric to imperial construction dimension conversions may vary due to industry standards.

All listed component weights are within a ±5% tolerance, not including system cabling or coolant, if applicable.

LIMITATION OF

LIABILITY

Information in this document is subject to change without notice and does not represent a commitment on the part of Varian Medical Systems, Inc. Varian Equipment CAD files can be provided, upon request, as a courtesy and are to be used for informational and layout purposes only. It is the responsibility of the architect and/or engineer of record to verify that all information used in their site-specific design complies with any applicable local, regional, or national ordinances, regulations, and/or laws and to ensure the completeness and constructability of the project drawings. Varian Medical Systems, Inc., its agents, and/or any subsidiaries shall not be liable for errors or omissions contained in this document or for incidental or consequential damages in connection with the furnishing or use of this material.

PUBLICATION

INFORMATION

Information in this publication is subject to change without notice and does not represent a commitment on the part of Varian. Varian is not liable for errors contained in this publication or for incidental or consequential damages in connection with the furnishing or use of this material.

The original publication is in English.

TRADEMARK

INFORMATION

Varian products referenced herein are either registered trademarks or trademarks of Varian Medical Systems in the U.S. and/or other countries. The names of other companies and products mentioned herein may be the trademarks of their respective owners. Any rights not expressly granted herein are reserved.

https://www.varian.com/ mailto:planning.ams@varian.com mailto:planning.apac@varian.com mailto:planning.emea@varian.com

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EXECUTIVE SUMMARY

Intended Audience

The intended audiences of this PPG are any Varian external customers or their representatives.

Purpose This document is designed to assist customers and their representatives in understanding the minimum requirements to enable a Varian EDGE to be installed. This document is a reference for the machine and site planning and does not cover specific site conditions that may require additional detailed design or safety solutions.

The information herein will be useful to project managers, architectural and site planners, construction engineers, contractors’ trade personnel, and others. Good site preparation and coordination between Varian and the customer’s representative are essential for smooth and efficient machine installation.

It is important to finalize the detailed design of the site configuration before construction is started. Once the site is completed, it will be difficult, and costly to make revisions.

Document Structure This document has four main sections:

Product Overview - System pictures, identification of deliverables, shielding, and references.

Varian System - Varian delivered parts, size, weight, and limitations.

Customer Requirements - Room sizes, utility, and environmental requirements in trade sections.

Project Management - Contractor tasks, durations, and responsibilities.

Project Planning

Once an order is placed, Varian will assign an Installation Project Manager (PM) to assist the customer and their representatives with the installation of the EDGE system. Refer to 4 Project Management for more information.

Typical Lead-times and Durations The times below may vary, confirm with Varian PM Minimum lead-time from Customer order – ~ 8 months (+ 1-month shipment for non-US orders) Cable lengths required – 6 weeks before delivery (+ 1-month shipment for non-US orders) Third-party products (Power Conditioner, Chiller, Lasers, etc.) – 12 weeks BaseFrame installation – 2 days Concrete cure time before machine installation – 4 weeks recommended.

Standard Installation (including rig and acceptance) – 4 - 5 weeks SuperFast Installation (including rig and acceptance) – 2 weeks Accelerator Commissioning - approximately 6 weeks, may vary.

Table 4-1 shows the detailed process and responsibilities for each major project milestone.

Site Readiness

The room must be clinically ready, meeting all the requirements within the PPG. All services and utilities must be available with the final finishes completed. The [1] Varian Accelerator Pre-Installation Checklist is used to measure compliance. Any tasks that are NOT completed must be approved by the Varian PM before the machine can be delivered. The Varian engineer must have exclusive possession of the treatment area during machine installation.

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REVISION HISTORY

REV DATE DESCRIPTION OF CHANGE AUTHOR

A October

• Initial Release DKU

B October

• Page 2 - reformatted

• Page 3 - Updated the Lead Times and Durations

• Table 1-1, Renamed E13 to Main Disconnect Panel

• Table 1-1, Removed E19 Printer

• New Section, 1.2 Compatibility

• 1.3, Updated the reference documents

• Figure 2-1, Added hand pendant to couch

• 2.2, Added to Note levelness verification and protection template

• New Section, 2.4 In-Room Monitors

• New Section, 2.5 USB Hub & Service Keyboard and Mouse

• New Section, 2.7 Respiratory Gating System

• 2.8, Revised the monitor space requirement

• Table 2-8, Added cable F4, network cable

• Table 2-8, Removed cable Route O”

• Table 2-10, Revised the IRM and Optical Imager mounting bracket and post weights

• Table 2-10, Revised the Speaker weight

• 2.10.4, Added CCTV camera input power specification

• 2.10.5, Reformatted the Ceiling Mounting Plates and Post section, moved some details to 3.1.5

• Figure 2-20, Updated image

• 2.11, Renamed to Main Disconnect Panel

• 2.11, Added bullet: optional 24V power for CCTV cameras

• 3, Consolidated customer responsibility Notices

• 3.1.1, Added Warning: The BaseFrame is the main structural component

• 3.1.1, Updated bullets:

• Added rebar minimum depth

• Updated Concrete finish level around the isocenter

• Added concrete backfill details

• Figure 3-1, Updated image, floor radius, and section details

• Table 3-1, Added Outer Trim Ring and Stand Mounting Pads

• 3.1.3, Added Warning on Code Compliance

• New Section, 3.1.4.1 Live View Camera

• New Section, 3.1.4.2 Motion View CCTV

• New Section, 3.1.4.3, Speakers

• New Section, 3.1.4.4, Laser plates

• Figure 3-6, Added tolerance for Optical Imager Post

• Figure 3-7, Revised clearance height requirement

• Figure 3-8, Revised clearance height requirement

• Figure 3-8, Added vertical camera tolerance

• New Figure 3-9, SGC Optical Imager

• 3.1.5, Added note for installation with IDENTIFY

• 3.2, Added bullet, Console cabinet located in a radiation-free environment

• Figure 3-10, Added Console Cabinet clearance height

• New Section 3.2.1, Console Floor Positioning Bracket

• Table 3-3, Added note about In-Rush Current

• Table 3-3, Removed Max. Fault Current specification

DKU

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• 3.3.2, Added note about third-party “Power Conditioning Equipment”

• 3.3.3, Added a note about the R.E.D. Box kit

• Figure 3-13, Revised the MV On and MV Off light colors

• New Table 3-6, RJB Customer Terminal Sizes

• 3.3.4.1, Added to note about the RJB neutral bar

• 3.3.5.2, Added IEC 60309 specifications

• 3.3.5.2, Removed outlet for printer

• New Figure 3-14, IEC 60309 Outlet

• 3.3.6, Added to Warning, equipment must be connected to Mains with protective earth

• 3.3.6, Revised component ground size to 4mm2 [12 AWG]

• 3.3.7, Added dedicated conduits or ducts

• 3.3.7, Added All conduits shall be smooth-walled

• 3.3.7, Added Verify all penetrations with the Physicist of Record

• Figure 3-16, Revised image

• 3.3.7, New Notice on conduit termination and total cable length

• Table 3-7, Revised maximum run length for cable runs B, C, & D

• Table 3-7, Added new cable run F4 and Removed cable run O

• New Section 3.3.7.1, additional containment requirements

• 3.3.8, Added maximum depth for zone A

• 3.3.8, Added minimum area for excess cable storage

• Figure 3-17, Added zone dimensions

• Table 3-8, Revised to provide minimum duct and pull box sizes

• 3.3.10.3, Added (1) N.O. and (1) N.C. contact

• 3.3.11, Updated the RJ-45 wiring pattern requirement

• Table 3-10

• Revised the flow range

• Revised the incoming coolant Celsius temperature

• Revised the Pressure Drop

• Figure 3-18, Replaced Facility Chilled Water Graph

• New Table 3-12, Added Altitude limit

• 3.4, Removed Optical Imager allowable temperature shift

• 3.8, Added IEC standard for Acoustic Energy

• New Table 3-16, Acoustic Levels

• 4.3, Responsibilities - Added customer acceptance

• 4.6, Responsibilities - Added pull Varian system cables

• 4.6, Responsibilities - Added load test for ceiling hook anchorage

• 4.6, Customer Supplied Resources - Added provide a dumpster

• New Appendix Table 1, Environmental Storage Conditions

• Appendix Table 2, Added BaseFrame, Couch, Couch PRS, Turntable, and Couch Top

• Removed "connected” Stand and Gantry rigging configuration

• Appendix A 2.1, Revised Gantry Rig Weight

• Appendix Figure 1, Updated image

• New Appendix Figure 3, Minimum Door Opening

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TABLE OF CONTENTS

1 Overview

Shielding Compatibility References

2 Varian System Dimensions Stand, Gantry, and Couch BaseFrame Modulator In-Room Monitors (IRM) USB Hub & Service Keyboard and Mouse Console Cabinet Respiratory Gating System (optional) Control Console Cables

Pre-Installation Kit (PIK) Main Disconnect Panel (MDP), Sales Option

3 Customer Requirements Treatment Room Control Area Electrical Plumbing Environmental Specifications Vibration Finishes Acoustic Fire Protection

4 Project Management Responsibilities Objectives BaseFrame Installation MDP and RJB Pre-Installation Kit (PIK) Delivery and RIG Radiation and Safety

Appendix A Shipping and Rigging Information 1 Crate Weights and Sizes 2 Rigging Information

Standard Configuration

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1 OVERVIEW

The Varian EDGE is specifically designed to deliver both radiotherapy and radiosurgery. A sophisticated and highly intelligent technology, this breakthrough system unlocks the ability to do tailored ground-breaking treatments with unprecedented ease, versatility, and speed. The EDGE system brings together state-of-the-art, real-time imaging with the ability to deliver higher doses with high precision. Because of this intelligent design, physicians can treat more complex cases and more patients. As sophisticated as it is, the EDGE system has been developed for ease of use. Designed with an emphasis on efficiency, the EDGE system is easy for a technician or a clinician to learn and operate.

Figure 1-1 EDGE Stand, Gantry, and Couch

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Figure 1-2 EDGE System Components (sample layout)

Table 1-1 EDGE System Components

E01 Stand & Gantry E11 Speaker (x2)

E02 Treatment Couch E12 USB Hub & Service Keyboard

E03 Modulator Cabinet E13 Main Disconnect Panel (opt. check SO)

E04 BaseFrame (Varian OEM) E14 Console Cabinet

E05 Relay Junction Box E15 IEC 60309 Power Outlet (opt. check SO)

E06 Positioning Laser (x4, opt. check SO) E16 System Monitors (x2, Treat and Image)

E07 In-Room Monitor Set (Dual Screen) E17 Control Console, Keyboard, and Mouse

E08 Patient Microphone E18 CCTV Monitor (x2)

E09 CCTV Camera (x2) E19 n/a

E10 Live View Camera E20 Optical Imaging Camera (opt. check SO)

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SHIELDING

WARNING

Varian Medical Systems shall have no approval or other responsibility for any matter affecting or related to the adequacy of the radiation protection walls and barriers or related safety devices. All radiation shielding designs must meet the codes and regulations of all Authorities Having Jurisdiction (AHJ) and must be approved by the Customer’s or Facility’s Physicist of Record and shall be the sole responsibility of the Customer/Facility. The hours of operation, patient workload, accelerator energy, and shielding materials should all be taken into consideration when calculating shielding requirements. Severe injury or death can result from improper radiation shielding.

• Consideration should be taken when locating linear accelerator equipment in the proximity of Magnetic Resonance Imaging (MRI) units or other magnetic field-generating equipment.

• The EDGE Accelerator and associated video monitors should be located outside of the 100 μT (1 Gauss) magnetic field.

COMPATIBILITY

NOTICE

All finishes and equipment in the treatment room should be suitable for an ionizing radiation environment.

Review the [2] TrueBeam Customer Release Notes for third-party device compatibility.

REFERENCES

The following reference/support documents are available from Varian Site Planning or the Varian PM.

[1] Varian Accelerator Pre-Installation Checklist [2] TrueBeam Customer Release Note (CRN) [3] MICAP Network Configuration Guide

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2 VARIAN SYSTEM DIMENSIONS

STAND, GANTRY, AND COUCH

The Stand, Gantry, and Couch are the main functional components of the machine that the users and patients will have contact with. Isocenter is the primary reference point for Varian equipment in the treatment room.

Figure 2-1 EDGE Stand, Gantry, and Couch (Side and Front View)

Figure 2-2 Couch Radius, Primary Beam Angle, and Source to Isocenter Distance

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Table 2-1 Treatment System Weights

Description Kg Lb Stand and Gantry 8507 18754 Couch and Couch Top 627 1382 Turntable Assembly 391 862 Total System excluding BaseFrame 9525 20998

BASEFRAME

The BaseFrame is the main structural component of the EDGE accelerator. It is installed into a recessed equipment pit below the finished floor level and is secured to avoid movement during final concrete placement.

Non-seismic anchors are provided and installed at the red dots indicated in the plan view. See 3.1.1 and 4.3 for more information.

Figure 2-3 BaseFrame (Plan and Side View)

For Varian machine replacements, the existing BaseFrame may be able to be reused pending a levelness verification test. During renovation construction, the use of a BaseFrame protection template is recommended. Contact Varian Site Planning or Varian PM for more information.

Table 2-2 BaseFrame Weight

BaseFrame 757 1669

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MODULATOR

The Modulator is the power supply cabinet to the EDGE system. The Modulator cabinet may be located either in the treatment room or remotely. Ventilation, acoustics, service provisions, and cable length must be considered in the final placement. See 3.1.3 for the required clearances.

Figure 2-4 Modulator (Front and Side View)

Table 2-3 Modulator Weight

Modulator 900 1985

An optional Moving Modulator Kit is available that permits the Modulator Cabinet to be installed in areas that cannot meet the required service clearance area, as shown in Figure 3-4. This kit positions one side of the Modulator Cabinet closer to the wall during clinical use while allowing it to be rolled away from the wall for service. This kit can be ordered from the Varian PM. There is a requirement for a service pit below the modulator to manage the interconnection power cables. Contact Varian Site Planning or Varian PM for more information.

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IN-ROOM MONITORS (IRM)

Two IRM displays are included as part of the standard EDGE equipment package. See 3.1.5 for location details.

Figure 2-5 In-Room Monitor

Table 2-4 IRM Weight

IRM 13.6 30

An additional set of IRM displays can be purchased as an option. Verify the quantity on the final sales order or with the Varian PM.

USB HUB & SERVICE KEYBOARD AND MOUSE

The USB Hub is used to support the wireless service keyboard and mouse and other optional devices in the treatment room.

Figure 2-6 USB Hub

Figure 2-7 Service Keyboard & Mouse

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CONSOLE CABINET

The Console Cabinet houses rack-mounted computers and imaging equipment required to run the system and user interface. It is powered by the Main Disconnect Panel. See Table 3-3 and 3.3.5.2 Control Area for details on the specific electrical requirements for the cabinet.

Figure 2-8 Console Cabinet (Front and Side View)

Table 2-5 Console Cabinet Weight

Console Cabinet 290 640

RESPIRATORY GATING SYSTEM (OPTIONAL)

An optional optical imaging system used to manage patient respiration motion during treatment delivery and imaging may be included with the equipment. There are two types Basic or Advanced, confirm the final equipment with the final sales order.

2.7.1 BASIC RESPIRATORY MOTION MANAGEMENT SYSTEM

Monoscopic Optical Imager – “Single Gating Camera” (SGC)

Table 2-6 SGC Optical Imager Weight

SGC Optical Imager 1.05 2.3

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Figure 2-9 SGC Optical Imager (Plan, Side, & Front View)

2.7.2 ADVANCED RESPIRATORY MANAGEMENT SYSTEM

Stereoscopic “Dual” Optical Imager – Includes a marker block kit for tracking patient respiration motion.

Table 2-7 Dual Optical Imager Weight

Dual Optical Imager 1.7 3.75

Figure 2-10 Dual Optical Imager (Plan, Side, & Front View)

Figure 2-11 Marker Block

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CONTROL CONSOLE

The Control Console is used to operate the EDGE. The components consist of:

• (1) Control Console, commonly referred to as the “Dedicated Keyboard”

• (2) System Monitors (Treat and Image)

• (2) CCTV Monitors

• (1) Standard Keyboard and Mouse (wired)

Figure 2-12 Control Console Layout

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CABLES

This section shows you the point-to-point connection and the maximum cable length available for the Varian-supplied system cables. Refer to Table 3-7 for maximum containment lengths.

Table 2-8 EDGE System Cables

Cable Route

Maximum Cable

Length # of

Cables Start Finish

A 30m [100’] 12

E01 - Stand

E03 - Modulator

B 45m [150’] 18 E14 - Console Cabinet

C 45m [150’] 7 E17 – Control Console

D 45m [150’] 1 E14 - Console Cabinet E20 - Optical Imaging Camera

E 30m [100’] 2 (up to x4)

E14 - Console Cabinet

E07 - In-Room Monitor

F1 15m [50’] 3 E16 - System Monitors

F2 15m [50’] 6 E17 – Control Console

F3 15m [50’] 2 E18 - CCTV Monitor

F4 15m [50’] 1 Network Jack (by Customer)

G 15m [50’] 1 E13 - MDP

H 45m [150’] 1 E13 - MDP E03 - Modulator

I 45m [150’] 2 E05 - RJB E01 - Stand

J 45m [150’] 2 E08 - Microphone E17 - Control Console

K 38m [125'] 1 E14 - Console Cabinet E10 - Live View Camera

L 45m [150’] 2 E11 - Speaker E17 - Control Console

M 45m [150’] 2 (up to x6) E09 - CCTV Camera E18 - CCTV Monitor

N 45m [150’] 1 E14 - Console Cabinet E12 - USB Hub

Table 2-9 Customer Specified Cables

P as required 4

E13 - MDP

E03 - Modulator

Q as required 3 E15 - IEC Outlet

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PRE-INSTALLATION KIT (PIK)

The PIK consists of Varian-provided mounting brackets, plates, posts, and electrical components. This kit is ordered and shipped to the site by the Varian PM for the customer to install before the EDGE delivery. The Varian-supplied components must be installed per local code and regulations using Customer-provided and sized mounting hardware engineered to support a combined maximum load as shown in Table 2-10.

Table 2-10 Pre-Installation Kit Weights

Bracket Weight Supporting Weight Description Kg Lb Kg Lb Floor Positioning Bracket 22 49 See Table 2-5 Relay Junction Box N/A 11 24 Laser Mounting Plates 1 2.2 ≤ 2.6 ≤ 5.7 CCTV Camera Mounts 1 2.2 2 4.5 IRM Ceiling Mounting Post (max.) 12 26.5 27.2 60 Optical Imager Ceiling Mounting Post (max.) 12 26.5 See Table 2-6 or Table 2-7 Live View Camera Post 0.5 1 3.2 7 Speakers N/A 0.8 1.75

2.10.1 FLOOR POSITIONING BRACKET

The floor positioning bracket allows for the proper positioning of the Console Cabinet. Refer to 3.2.1 for installation clearance requirements.

Figure 2-13 Console Cabinet Floor Positioning Bracket

2.10.2 RELAY JUNCTION BOX (RJB)

The RJB is a factory-assembled and tested control panel that provides a central interface connection point between the EDGE Accelerator and the treatment room main room lights, system status warning lights, patient positioning lasers, door interlocks, and remote emergency-off push buttons. Refer to

3.3.4 Relay Junction Box (RJB) for more information.

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• The door hinges are on the left side of the RJB.

Figure 2-14 Relay Junction Box (Front and Side View)

2.10.3 LASER MOUNTING PLATES

The patient is aligned to the accelerator's isocenter with positioning lasers. The lasers are powered and controlled by a common circuit that is connected to the RJB.

• Four steel Laser Mounting Plates are provided, refer to 3.1.4.4 Laser Mounting Plates.

Lasers are not a standard part of the EDGE system but may be supplied by Varian as part of the equipment order. Contact Varian Sales or Varian Site Planning for more information on available options.

Figure 2-15 Laser Mounting Plate

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2.10.4 MOTIONVIEW CCTV CAMERAS

A Closed-Circuit Television (CCTV) system is required for safe operation. It is critical to patient safety that the therapist always maintain visual contact with the patient. Refer to Figure 3-5 and Section 4.5 for more information.

• A two-camera MotionView CCTV camera system is standard with EDGE.

• Additional two-camera MotionView CCTV camera systems may be purchased as an option, up to a maximum of 6 cameras.

• Each CCTV camera has a dedicated monitor in the console area, see 2.8 Control Console.

• 18 to 30 VAC, 50/60 Hz (24 VAC, 0.875 A, nominal)

Figure 2-16 CCTV Camera Mounts (Plan, Front, and Side Views)

2.10.5 CEILING MOUNTING PLATES & POSTS

Aluminum ceiling mounting plates, configurable posts, and mounting brackets are provided as part of the PIK for installing the In-Room Monitors (IRMs) and the Dual Optical Imager or the SGC Optical Imager. Refer to 3.1.5 for installation locations and heights.

Figure 2-17 Ceiling Mounting Plate and Post Section

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Figure 2-18 Ceiling Mounting Post (minimum and maximum configuration lengths)

The posts are configurable in approximately 15cm [6"] increments from the minimum to the maximum shown above. See for installation positioning.

2.10.6 LIVE VIEW CAMERA MOUNT

The Live View (LV) Camera enables monitoring of the EDGE and the patient. The system provides proximity information while the machine is moving to help prevent injury to the patient, refer to Figure 3-5 for the installation location.

Figure 2-19 Live View Camera Wall Mount (Plan and Side View)

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2.10.7 SPEAKERS AND MICROPHONE

Two speakers and two microphones are a standard part of the EDGE system that provides intercom and audio services in the treatment room, operated by the Control Console.

• The microphones are Varian-installed

• The speakers are Customer-installed

• Refer to Figure 3-5 for the installation location

Figure 2-20 Microphone and Speaker (Side and Front Elevations)

MAIN DISCONNECT PANEL (MDP), SALES OPTION

The MDP is the main power distribution point to the EDGE system. The MDP includes safety features to properly control power to the system and depending on the model, may offer additional safety circuits.

• Provides a single point of connection for the site’s 3-phase power to the EDGE System

• Splits the Mains power into two independent switchable power outputs, refer to 3.3.1 Power Requirements

• To the Modulator Cabinet

• To the Control Cabinet, via an IEC 60309 outlet provided with the MDP

• Provides for various system safety features:

• Overcurrent protection for the outputs

• Mains Incoming Power Switch (non-emergency)

• Lock Out/Tag Out capabilities for maintenance safety

• Emergency Disconnect Button

• System Start

• Option to provide 24V power for up to 6 CCTV cameras

The MDP and the IEC 60309 outlet are not a standard part of the EDGE system but can be supplied by Varian as part of the equipment order.

If the MDP is not part of the equipment sales order, then it can be ordered directly from the manufacturer. Contact Varian Site Planning or Varian PM for more information.

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3 CUSTOMER REQUIREMENTS

It is the Customer’s responsibility:

To determine the quantity, size, and type of mounting hardware required to adequately and seismically anchor the Varian-provided components to the floor, walls, and ceiling.

To ensure that the site-specific design documents for the Varian system, to be installed, comply with all applicable local, regional, and national codes and regulations.

Compliance must address but is not limited to proper egress, adequate separation of services, and required clearances for equipment with hazardous voltages.

The customer is responsible for the safety of the equipment layout in the Control Area and Treatment Room, particularly with the ceiling and wall-mounted equipment.

TREATMENT ROOM

3.1.1 BASEFRAME PIT

The BaseFrame is supplied with mounting hardware that is NOT suitable for sites subject to seismic activity. It is the responsibility of the customer to provide a qualified structural engineer to determine the quantity, size, and type of mounting hardware required for seismically anchoring the Varian-provided components to the pit floor. Contact Varian Site Planning or Varian PM for more information.

The BaseFrame is the main structural component of the medical device.

Any modification, alteration, or damage is strictly prohibited and will result in the BaseFrame having to be replaced at considerable expense and time.

• The pit floor shall be designed by a qualified structural engineer capable of carrying the total weight of the fully assembled accelerator, see Table 2-1 and Table 2-2.

• Structural rebar must be a minimum of 7.5cm [3”] below the pit floor level.

• The BaseFrame pit depth shall not vary more than 6mm [1/4"].

• The concrete finished floor must be level within ±3mm [±1/8”] for a 183cm [6’-0”] radius about the isocenter, see the yellow shaded area shown in Figure 3-1

• All exposed concrete shall be suitably sealed before the BaseFrame Installation.

• Cable and chilled water line access must be considered before backfilling the pit with concrete.

• The backfill concrete in the pit around the BaseFrame must be leveled to the Outer Ring (D) and the Stand Mounting Pads (F). This should be performed the same day as the BaseFrame installation so levelness can be verified by Varian and signed off by the Customer.

• Refer to 3.4.2 Cooling Line Access for details on the chilled water connection point.

• Contact the Varian PM and refer to 4.3 BaseFrame Installation, for a detailed explanation of the installation procedure.

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Figure 3-1 Minimum BaseFrame Pit Dimensions

Table 3-1 BaseFrame Pit Key

A Structural Concrete (by Customer) F Stand Mounting Pads, BaseFrame

B Backfill Concrete (by Customer) G Foam Backer (by Varian)

C BaseFrame (by Varian) H Finished Flooring (by Customer)

D Outer Ring, BaseFrame I Chilled Water Supply and Return

Isolation Valves (by Customer) E Turntable Trim Ring, BaseFrame

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3.1.2 STAND, GANTRY, AND COUCH CLEARANCES

3.1.2.1 MINIMUM FLOOR-LEVEL CLEARANCES

The area highlighted in Figure 3-2 shows the operational and service clearances required for the EDGE Stand, Gantry, and Couch.

Figure 3-2 Minimum Room Clearances

CAUTION

The maximum couch arc allows complete rotation of the Couch Top at full retraction. Obstructions inside the minimum required couch arc can result in injury to patients and medical personnel as well as equipment damage.

• Refer to Figure 2-2 for the minimum and maximum couch arc radii

Obstructions between the minimum required couch arc and the maximum couch arc may be considered provided they are reviewed and approved by Varian and the Customer. In specific situations, such as dynamic stereotactic treatments, a larger area may be required.

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3.1.2.2 OVERHEAD CLEARANCES

The area highlighted in Figure 3-3 shows the overhead installation, operational, and service clearances required for the EDGE Stand, Gantry, and ceiling-mounted components.

Figure 3-3 Minimum Overhead Clearances

• Provide 274cm [9'-0"] minimum clearance from the finished floor to the finished ceiling.

• Additional clearance height will be required for the ceiling laser that is mounted directly above the isocenter.

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3.1.3 MODULATOR CABINET CLEARANCES

The operational, cabling, and minimum service clearances required for the Modulator area are highlighted in Figure 3-4. Refer to 2.3 Modulator and 3.3.8 Cable Access for more information.

NOTICE Do not locate the Modulator in the accelerator’s primary beam path, refer to

Figure 2-2.

Figure 3-4 Modulator Minimum Service Clearances

It is the customer’s responsibility to ensure that all electrical safety clearances around the Modulator comply with local, regional, and national codes and regulations.

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3.1.4 SAGITTAL WALL COMPONENT LOCATIONS

NOTICE Provide structural support as required, refer to Table 2-10 for component weights.

Figure 3-5 Treatment Room Sagittal Wall Elevation

3.1.4.1 LIVE VIEW CAMERA

• The LV camera is Varian-installed, refer to 2.10.6 for component details.

• The LV wall mounting post is Customer-installed.

• Wall mount the LV camera post on either side of the isocenter, refer to Table 3-2 for the installation area for the LV camera (E10).

• Provide cable access within 15cm [6”] of the LV mounting post.

Table 3-2 Live View Camera Post Installation Area

Distance from Isocenter to Sagittal Wall

Dimension "A" from The Sagittal Plane

Dimension "B" from Finished Floor

260 - 300cm [8'-6" - 9'-10"]

50 - 100cm [1'-8" - 3'-3"]

200 - 220cm [6'-6" - 7'-3"]

300 - 350cm [9'-10" - 11'-6"]

50 - 100cm [1'-8" - 3'-3"]

210 - 240cm [7'-0" - 7'-10"]

350 - 400cm [11'-6" - 13'-2"]

50 - 150cm [1'-8" - 4'-11"]

220 - 250cm [7'-2" - 8'-2"]

400 - 610cm [13'-2" - 20'-0"]

50 - 150cm [1'-8" - 4'-11"]

230 - 270cm [7'-6" - 8'-10"]

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3.1.4.2 MOTIONVIEW CCTV CAMERAS

NOTICE Do not locate the secondary or CCTV cameras in the accelerator’s primary beam path, refer to Figure 2-2.

The MotionView CCTV camera housing is wall-mounted by the customer. The CCTV cameras are Varian-installed, refer to 2.10.4 for component details.

• The primary MotionView CCTV (E09) two-camera system location shown in Figure 3-5 is MANDATORY for patient safety.

• If additional MotionView CCTV camera systems are purchased, the installation location is Customer preference (not shown).

• Provide cable access for the CCTV camera through the Varian-provided wall-mount housing.

3.1.4.3 SPEAKERS AND MICROPHONES

• Wall mount the Speakers (E11) towards the front of the treatment room outside the primary beam path. The installation location is Customer preference, refer to 2.10.7 for component details.

• Provide cable access within 15cm [6”] of the Speaker.

• The primary Microphone (E08) will be Varian-installed on the LV camera.

• Refer to 3.1.4.1 for cable access.

• The secondary microphone will be Varian-installed on the false ceiling typically near the ceiling-mounted IRMs using the 25mm [1”] T-bar clip post (not shown), see Figure 2-20.

3.1.4.4 LASER MOUNTING PLATES

The mounting structure must be vibration-free and accessible for service.

DO NOT mount to wood, gypsum board, light gauge steel framing, or suspended ceiling grid.

• Refer to 2.10.3 for component details.

• The sagittal Laser Mounting Plate (E06) installation height is variable, 230cm [7’-6”] is the recommended height to avoid any obstructions with the laser alignment beam, see Figure 3-5.

Consult with the laser manufacturer and customer on the desired elevation.

• Install the side Laser Mounting Plates at 130cm [4’-3”] above the finished floor (not shown).

• Install the ceiling Laser Mounting Plate directly above the isocenter, the mounting plate may be installed parallel or perpendicular to the sagittal plane.

The Sagittal Laser plate may be installed vertically, as shown in Figure 3-5, or horizontally, depending on the laser model. The mounting plate has two isocenter alignment holes for installation flexibility. Contact the Varian PM or laser manufacturer on installation orientation options.

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3.1.5 IRM AND OPTICAL IMAGER

• The IRMs (E07) in Figure 3-6, may be located on either side of the isocenter, typically on the opposite side of the maze entrance, refer to 2.10.5 and 4.5 for more information.

• The Optical Imager is located along the longitudinal axis line of the couch.

The mounting structure must be vibration-free and accessible for service.

DO NOT mount to wood, gypsum board, light gauge steel framing, or suspended ceiling grid.

Orient the plate's long centerline parallel with the longitudinal axis line of the couch.

DO NOT locate the IRMs inside or within 60cm [24”] of the primary beam path, refer to Figure 2-2.

WARNING The customer must maintain a minimum clearance of at least 203cm [6'-8"] between the floor and ceiling-mounted equipment.

Figure 3-6 Treatment Room Ceiling Mounted Components (Plan)

The IRMs may be wall-mounted. Contact Varian Site Planning or Varian PM for more information.

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Figure 3-7 IRM Mounting Height

Figure 3-8 "Dual" Optical Imager Mounting Height Figure 3-9 "SGC" Optical Imager Mounting Height

• “A” – refer to Figure 2-18 Ceiling Mounting Post (minimum and maximum configuration lengths)

213cm [7’-0”] is the recommended mounting height to the bottom of the post.

For installations with IDENTIFY refer to PPG-ID for the post height requirements.

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CONTROL AREA

Figure 3-10 is a generic layout, component positioning may vary per site-specific conditions, consult with the Customer on the desired layout, and if any additional space is required.

• Refer to Table 2-9 for maximum cable lengths from the Console Cabinet to the desktop components.

• The Console Cabinet must be located in a radiation-free environment.

Figure 3-10 Generic Control Console Layout

If additional MotionView CCTV camera systems are on the final sales order, provide additional space at the Control Console for the extra CCTV monitors.

3.2.1 CONSOLE FLOOR POSITIONING BRACKET

CAUTION The Floor Positioning Bracket must be installed. Locking pins prevent the

Console Cabinet from tipping over or rolling unintentionally.

• The attachment hardware is Customer-provided.

• (8) - 12.7mm [1/2”] diameter mounting holes.

Figure 3-11 Console Cabinet Service Clearances

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ELECTRICAL

3.3.1 POWER REQUIREMENTS

The Mains power to the EDGE MDP must be provided from a private branch circuit (for example, sourced from a dedicated transformer). Utilities such as room lighting, receptacles, or other equipment must be powered from a separate source.

Table 3-3 System Power Requirements

Input Voltage 200VAC, 208VAC, 240VAC, 380VAC, 400VAC, 415VAC, or 480VAC (nominal)

System Current 100A @ 400V 50Hz or 80A @ 480V 60Hz

Console Current 20A @ 200-230V (50/60Hz), 1-phase, neutral, and ground

Line Voltage Regulation

±5%. This is the maximum allowable steady-state deviation from the nominal value selected. Sinusoidal with less than 5% total harmonic distortion.

Maximum Phase Voltage Imbalance

3% of the nominal value. This is the maximum difference between any 2-phase voltages when operating at full load (Beam-On).

Input Frequency 50 or 60 Hz ±1 Hz.

Electrical Loads 7kVA in Stand-By state, 48kVA in Beam-On state. (Including console, 3kVA)

Long-Time Load 48kVA (Including console, 3kVA)

In-Rush Current At power on, and in various operational modes there is a momentary surge which is approximately 3 – 4 times the normal operational requirements. Contact Varian Site Planning for more information.

Power Factor Equal to or greater than 90%, inductive load.

The line-current waveform is non-sinusoidal.

Source Impedance 2.5% maximum For 45kVA: 208VAC = 24.0 mOhm; 400VAC = 88.8 mOhm For 48kVA: 208VAC = 22.5 mOhm; 400VAC = 83.3 mOhm

Mandatory Grounding

See 3.3.6 Dedicated Ground/Protective Earth Requirements

3.3.2 POWER CONDITIONING REQUIREMENTS

The equipment is sensitive to line voltage variations and source impedance. A complete survey of the electrical supply should be conducted before the equipment installation and a copy of this survey should be sent to the Varian PM for the equipment file. Isolation transformers and/or power conditioners are required where the electrical power requirements specified in Table 3-3 cannot be met.

Transients lasting no more than a few cycles will not cause harm if limited to the specified steady-state line voltage regulation. Transient suppression is required where larger, long-lasting, or frequent transients occur as these can cause interruption of operation and/or equipment damage.

For sites that intend to use third-party “Power Conditioning Equipment”, contact Varian Site Planning for more information.

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3.3.3 MAIN DISCONNECT PANEL (MDP)

• The Customer wiring:

• Input to the MDP (E13) – Line-to-line, 5-wire (3-phase, neutral, and ground)

• Output to the Modulator (E03) – Line-to-line, 4-wire (3-phase and ground)

• Wall mount the MDP at a standing height from the finished floor.

• The MDP must be visible from and within 3m [10'-0"] of the Console Cabinet.

If the MDP cannot be located near the Console Cabinet contact the Varian Planning Department for more information about using the Remote Emergency Disconnect (R.E.D.) Box kit.

Customer-provided wiring

Varian-provided cables

Figure 3-12 Generic MDP Panel Components

Table 3-4 Generic MDP Components

A Circuit Breaker 1 B Circuit Breaker 2 C K1 Contact D Transformer (optional per A input voltage) E Circuit Breaker 3 F K3 Contact G Transformer H Start Button I Emergency Disconnect Button

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3.3.4 RELAY JUNCTION BOX (RJB)

NOTICE Do not locate the RJB in the primary beam path.

• Wall mount the RJB in the treatment room at a standing height from the finished floor for service accessibility.

• The RJB may be surface-mounted or semi-recessed, up to a maximum of 12cm [4 3/4”].

3.3.4.1 RJB CUSTOMER CONNECTIONS

Figure 3-13 RJB Customer Connections

Table 3-6 RJB Customer Terminal Wire Range

Description Metric Imperial Customer Input Terminals 0.75 to 10mm2 18 to 6 AWG

Table 3-5 RJB Connections

Device Power Notes

A Main Room Lights 100 – 277 VAC (50/60Hz), 20A maximum 3.3.9 Room Lighting

B Warning Lights 100 – 250 VAC (50/60Hz), 10A maximum 3.3.10.1 Warning Lights

C Lasers Power Outlet 100 – 250 VAC (50/60Hz), 10A maximum 3.3.5.1 Treatment Room

D DC Door Interlock 24 VDC, provided by the RJB

3.3.10.2 Door Interlock Switches

E AC Door Interlock 120 VAC, provided by the RJB

F EMO, “safety loop”, Normally Closed

24 VDC, provided by the RJB

3.3.10.3 Emergency Off

G EMO, “sensor loop”, Normally Open

24 VDC, provided by the RJB

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Additional 24 VDC system interlocks are available in the RJB. Contact Varian Site Planning or Varian PM for more information.

The Customer-supplied neutral wires may be terminated on the RJB neutral bar or by other means as per local electrical codes. The RJB neutral bar is provided for convenience.

3.3.5 POWER OUTLETS

3.3.5.1 TREATMENT ROOM

• (1) Standard power outlet within 92cm [3’-0”] of each Laser (E06), wired to the RJB (E05)

• (1) Standard power outlet, within 122cm [4’-0”] of each IRM (E07)

• (1) Standard power outlet within 30cm [1’-0”] of each CCTV camera (E09)

• Optionally the CCTV cameras can be powered by a Customer-provided 24VAC source

• (1) Standard power outlet for the USB Hub (E12)

The 1-phase power to some accessory items can be provided by the MDP, depending on the design and functionality of the MDP. Contact Varian Site Planning or Varian PM for more information.

3.3.5.2 CONTROL AREA

NOTICE Do not install the IEC outlet directly behind the Console Cabinet. Locate on either side of the Console Cabinet, refer to Figure 3-10.

• (1) IEC 60309 outlet (E15) located on either side of the Console Cabinet

• 2-pole, 3-wire, 6-hour position, blue

• 30A, 250VAC - North American rated

• 32A, 220 – 250VAC - European rated

Figure 3-14 IEC 60309 Outlet (Front View)

• Provide additional power outlets for convenience as required by the Customer.

The System Monitors and CCTV Monitors are powered from the Console Cabinet.

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3.3.6 DEDICATED GROUND/PROTECTIVE EARTH REQUIREMENTS

The customer-provided G/PE conductor for the Mains power supply must meet or exceed code requirements and be equal in size to the supply/power conductors but, no smaller than 16mm2 [6 AWG].

To avoid the risk of electric shock, this equipment must be connected to a supply Mains with protective earth. Do not ground to water supply piping.

The EDGE accelerator requires two Ground/Protective Earth (G/PE) circuits. The first circuit is part of the main power supply and provides grounding for the EDGE Accelerator’s major system components. Varian provides and installs the internal grounding cable between the Stand/Gantry, Modulator, Couch, and Console Cabinet. The Customer provides the ground from the MDP (E13) to the Modulator (E03) in Figure 3-15 as per 3.3.3 Main Disconnect Panel (MDP).

The second G/PE circuit is for the wall- and ceiling-mounted EDGE accessory components that are located at or below 250cm [8’-2 1/2"] from the finished floor.

The Contractor shall install a single G/PE conductor, 4mm2 [12 AWG] minimum, from each of the components in Figure 3-15 to the facility’s main ground. This grounding system provides compliance with IEC 60101 and -01. This G/PE conductor can be combined with the cable runs outlined in 3.3.7 Cable Containment.

Figure 3-15 Ground/Earthing Conductor Layout

• RJB (E05)

• LV Camera and Microphone (E10)

• IRM Post (E07)

• Optical Imaging Camera Post (E20)

• Laser Mounting Plates (E06)

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3.3.7 CABLE CONTAINMENT

The customer is responsible for ensuring that the cable installation meets applicable local codes and requirements. This might affect the choice of cable routes, number of conduits/ducts, specifications of Mains power and data cables, and the choice of installation locations of system components.

The customer shall provide dedicated conduits or raceway ducts for the Varian system cables.

System cables are not plenum-rated.

System cables shall not be permanently installed through a walking path.

• All conduits shall be smooth-walled.

• All conduits that are routed underground shall be dry and watertight.

• Terminate conduits with insulating bushings or similar means to protect cables from abrasion.

• Conduit bends shall have a radius no less than 6 times the conduit’s diameter.

• There shall be no more than three 90-degree bends per conduit (or equivalent).

• Verify all room penetrations with the Physicist of Record.

• Reference Table 2-8 EDGE System Cables for maximum cable lengths.

• The cable route must be shorter than the maximum cable length. Allow for 3m [10’-0”] of excess cable at each end for connection and service, unless otherwise noted.

Figure 3-16 Cable Containment Identification

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Do not terminate conduits behind the Console Cabinet (E14).

Include the distance from the conduit termination location to the back of the Console Cabinet or the Desktop components, indicated by the * or ** in Figure 3-16, as part of the total run length.

Table 3-7 EDGE Containment Specifications

Cable Route

Minimum Conduit Size Ø

Conduit Quantity

Maximum Run

Length Start Finish

A

100mm [4”]

3 24m [80’]

E01 - Stand

E03 - Modulator

B 3 39m [130’] E14 - Console Cabinet

C 1 39m [130’] E17 - Control Console

D 75mm [3”] 1 39m [130’] E14 - Console Cabinet E20 - Optical Imaging Camera

E 50mm [2”]

(up to x2) 24m [80’]

E14 - Console Cabinet

E07 - In-Room Monitor

F1 n/a n/a

12m [40] E16 - System Monitors

F2 12m [40] E17 - Control Console

F3 12m [40] E18 - CCTV Monitor

F4 12m [40] Network Jack (by Customer)

G

50mm [2”]

1 11m [36’] E13 - MDP

H 1 41m [135’] E13 - MDP E03 - Modulator

I 2 41m [135’] E05 - RJB E01 - Stand

J 32mm [1.25”]

1 42m [140] E17 - Control Console E08 - Microphone

K 1 35m [115’] E14 - Console Cabinet E10 - Live View Camera

L

25mm [1”]

2 42m [140] E17 - Control Console E11 - Speaker

M 2 (up to x6) 42m [140] E09 - CCTV Camera E18 - CCTV Monitor

N 1 42m [140] E14 - Console Cabinet E12 - USB Hub

P Customer Specified

1 41m [135’]

E13 - MDP

E03 - Modulator

Q 1 per site E15 - IEC Outlet

Larger conduits may be used to group cables to optimize the cable runs between the control area and treatment room before separating them to their final locations. Contact Varian Site Planning for more information on these options.

Cable Runs F1, F2, F3, and F4 may be bundled together and run below the countertop. A wire management system is recommended for aesthetics and to provide cable protection.

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3.3.7.1 ADDITIONAL CONTAINMENT REQUIREMENTS

The following Customer-provided safety components require a containment path to the RJB, not shown in Figure 3-16.

• Lasers

• Warning Lights

• Door Interlock Switches

• Emergency-Off Buttons

Consult with the Customer on the requirements for an Experimental Access (Physics Q/A) Port.

3.3.8 CABLE ACCESS

Cable access zones to the BaseFrame and Modulator are indicated in Figure 3-17, refer to Figure 3-1 for BaseFrame pit depth.

• Zone A is accessible from below the pit slab or from the rear through Zone B.

• The maximum depth for zone A is 61cm [24”] below the finished floor level.

• Conduits below the BaseFrame must be a minimum of 45cm [18”] below the finished floor level.

• Zone B is centered on the BaseFrame.

• The minimum width for zone B is shown below and must be coordinated with the chilled water access in Figure 3-20.

• Zone C is accessible from below the Modulator, refer to Figure 3-4 for Modulator clearances.

• Provide a minimum of 0.07m3 [2.5 ft3] storage for excess cable in Zone C

Figure 3-17 BaseFrame and Modulator Cable Access

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Table 3-8 Modulator Zone C

Cx Cy C Depth

Duct 30 – 45cm [12” – 18”] 150cm + [5’-0” +] 15cm [6”]

Pull Box 45cm [18”] 60cm [24”] 25 – 30cm [10” – 12”]

NOTICE If the isocenter to the rear wall is less than 335cm [11’-0”] contact Varian

Site Planning when using Zone B for cable access.

3.3.9 ROOM LIGHTING

Main room lights are used for general illumination and room maintenance. Typically, the main room lights are controlled (on/off) from the treatment couch during patient setup through voltage-free contacts located in the RJB, refer to Figure 3-13.

Setup lights are normally dimmable fixtures that allow the intensity to be adjusted by the therapists while aligning the patient to the laser lights. The setup lights are typically located above and to either side of the treatment couch. Their control is independent of the equipment.

Room lighting can be configured in multiple ways as defined by the customer's requirements.

Contact Varian Site Planning for more information.

3.3.10 EMERGENCY AND SAFETY DEVICES

To meet safety regulations, the following customer-provided safety device systems must be installed per the customer's Radiation Safety Officer and to comply with regional regulatory agency requirements.

3.3.10.1 WARNING LIGHTS

System warning lights are required inside and outside the treatment room to indicate beam-on/beam-off conditions. They may be required to blink when the beam is on. Colored (usually red) lights must be placed such that one is visible from any point in the treatment room. There are five individual warning light circuits available in the RJB, refer to Figure 3-13.

• Provide an individual warning light for each circuit.

• Incandescent lamp load, 60W maximum, each circuit.

• 5A maximum, resistive load, including any short-duration switching transients.

• LED fixtures are acceptable, the inrush current for all fixtures must be less than the rating above.

• Fluorescent fixtures are not allowed.

• Combination signs with superimposed lettering are not allowed.

If a greater load is required, these circuits can be used to control separate, customer-provided relays.

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Table 3-9 Warning Lights

Beam READY Illuminates to show the MV system has no open interlocks and is ready to treat.

Beam ON Illuminates during MV beam treatment (mandatory).

Beam OFF Illuminates when the accelerator is not in a radiation-generating state.

Generator ON Illuminated to show the KV system is ready to image the patient.

X-Ray ON Illuminates during KV imaging, mandatory for accelerators with On-Board Imaging.

To comply with IEC 60601-2-1: 2009 +A1:2014 aural indicator requirements (Clause # 201.10.1.2.101.10) the customer shall provide and install a suitable aural indicator in parallel with any warning lights connected to the

RJB.

3.3.10.2 DOOR INTERLOCK SWITCHES

Door interlock switches are mandatory for all installations to ensure the treatment room door is closed during accelerator operation. Provide two independent safety switches, a primary and a secondary switch. The primary and secondary switches must be in the same state (both open or both closed) within 5 seconds of actuating, refer to Figure 3-13 for connection details to the RJB.

• Primary – 120VAC, 500mA (typical load), normally open contact

• Secondary – 24VDC, 1mA (typical load), normally open contact

For double-entry doors, each door panel requires a set of interlock switches. The primary and the secondary switches on each door panel must be wired in series to the RJB, separate from each other.

For secondary neutron doors, a 24VDC switch should be independently wired to the neutron door inputs in the RJB.

3.3.10.3 EMERGENCY OFF BUTTONS

The Emergency-Off (EMO) button removes the Mains power from the Accelerator and Modulator while still allowing power to the Console Cabinet UPS. EMO buttons are built into the Accelerator Stand (x2), Couch (x2), Control Console (x1), and Modulator (x3).

Additional Customer-provided EMO buttons are typically required in the treatment room. Consult with the hospital’s Radiation Safety Officer to verify the site requirements.

• Two-pole, (1) normally open and (1) normally closed contacts, “dry”, manual…