Halcyon DDR.pdf

HALCYON

PRODUCT PLANNING GUIDE

P1029751 OCTOBER 2018

HALCYON

P/N : P1029751-02

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Halcyon

Introduction to the Varian Product Planning Guide (PPG) (Adobe© Acrobat .PDF format)

Language of Origin The origin of this publication is of English-language, the English version should always be considered the master.

Conventions Dimensions and Tolerances Units are shown as SI units first in the format – Metric [Imperial] - cm [inches], Tolerances are given where critical otherwise general tolerances from ISO 4463-1: 1989 should be used. All dimensions, unless stated, are from finished surfaces.

Digital Drawing Files AutoCAD DWG files for all sections within this document are available from your Varian Regional Planner. These files contain details that can be useful for incorporating into the Architect’s contract documents.

Varian Medical Systems Planning Group, Site Services 660 N. McCarthy Blvd., Milpitas, CA 95035 Phone: (800) 278-2747 or (408) 232-4231 https://www.varian.com

Americas:

Email: planning.ams@varian.com Asia Pacific, Australia and China:

Email: planning.apac@varian.com

Europe, Middle East, India and Africa:

Email: planning.emea@varian.com

Limitation of Liability Information in this document 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 document or for incidental or consequential damages in connection with the furnishing or use of this material. This document contains proprietary information protected by copyright. No part of this document may be reproduced, translated, or transmitted without the express written permission of Varian Medical Systems, Inc.

Trademarks Halcyon, TrueBeam® and VitalBeam™ are trademarks or registered trademarks of Varian Medical Systems, Inc. these and/or other Varian Medical Systems Inc.’s products referenced herein are either trademarks or registered 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.

Release History (For detailed of changes and revisions please see release notes)

© 2018 Varian Medical Systems, Inc.

All rights reserved.

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

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MANAGEMENT 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 to understand the minimum requirements to enable a Varian Halcyon 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 here in 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 is essential for a 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 a Hardware Installation Project Manager (PM) to assist the customer and their representatives with the installation of the Halcyon system.

All pre-installation dates for Varian deliverables and milestones are scheduled by the Varian PM, based on an agreement between the customer and the Varian PM and communications with Varian Planning and Sales. The Varian PM will communicate regularly with the customer throughout all phases of the project. In addition, the Varian PM typically performs site visits to help answer questions during the construction progress.

Site visits are commonly held for the Initial Site Meeting/Project Kick-off and the Pre-Installation Inspection to show construction completion. This final visit typically occurs 10-14 days prior to the rig date to verify 100% completion as defined by the Varian Accelerator Pre-Installation Checklist [2].

Typical Lead-times and Durations Min. lead-time from Customer order – 3 months + 1-month Shipment (for non-US orders)

Third-party products (Power Conditioner, Chiller, etc.) - 10 weeks Standard machine installation including acceptance (Total) – 12 Days

• Equipment Delivery and Rig-In – 1 days

• Machine Cabling and Power up – 4 days

• Initial Beam on and Acceptance Preparation – 3 days

• SW installation – 1 day

• System Verification Summary (SVS) – 1 day

• Acceptance – 1 day

• Clean-Up, Finalize Paperwork – 1 day

Commissioning – 1 to 2 days (Customer's discretion)

Section 4 of this guide contains 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 Varian Accelerator Pre-Installation Checklist [2] is used to measure compliance. Any tasks that are NOT complete 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 NAME

A Sept 2018 Initial release D. Kuntz, D. Grossmith, B Oct 2018 Metric dimension correction DK

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TABLE OF CONTENTS

1 Overview

Shielding References Glossary and AbBreviations

2 Varian System Dimensions Gantry and Couch Console Cabinet Console Floor Bracket Console and Monitors Pre-Instalation Kit (PIK) Accessories Kit

CCTV

Cables

3 Customer Requirements Spacial Electrical Plumbing Environmental Specifications Vibration Acoustic Finishes

4 Project Management Responsibilities Objectives MDP and RJB Delivery and RIG Customer Acceptance and Safety

Appendix A Shipping and Rigging Information

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1 OVERVIEW

Varian Medical Systems designed the Halcyon linear accelerator so that modern 21st century radiotherapy treatment techniques could be offered in a way that greatly streamlines the treatment delivery process and clinical operations.

Utilizing advanced technology that was developed and pioneered on this treatment delivery platform, the Halcyon system represents a complete reformulation of the linear accelerator concept around operational efficiency for the clinic with a focus on the patient experience. The clinical operator is guided through the workflow by the user interface so that a given patient can be treated in a reproducible manner during every therapy session.

In order to effectively treat lesions throughout the entire body with high clinical quality, the foundational treatment capability of the Halcyon system is built upon image-guided intensity modulated radiotherapy.

Thus the imaging and beam modulation properties of the Halcyon system are differentiated from that of a typical C-arm linear accelerator.

The system is integrated with the Eclipse® treatment planning system and ARIA® oncology information system software environments to support a range of Halcyon clinical operational roles in a variety of network configurations ranging from a stand-alone multi-purpose linac in a single vault clinic all the way to a dedicated role, such as an image-guided RapidArc® specialty machine within a fleet of linacs in a large-hospital network.

Figure 1-1 Halcyon Gantry and Couch

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Figure 1-2 Identification of Varian Components

The Halcyon system is design to fit into very small rooms with a design that can have direct entry, via a suitably shielded door, or as above into an existing room with a maze entry. The above drawing is for component identification and the room outline is for information only.

Table 1-1 Halcyon Components

Halcyon Component and ID’s

Y01

Stand & Gantry Y03 Console Cabinet

In-Room Monitor Set (integrated) Y04 System Monitors (x2, Image and Data)

Positioning Laser (integrated) Y05 Control Console

Speaker (integrated) Y06 USB Keyboard and Mouse

Patient Microphone (integrated) Y07 Main Disconnect Panel, MDP

Y02 Treatment Couch Y08 IEC 60309 Power Outlet

Live View Camera (integrated) Y09 Relay Junction Box, RJB

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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 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 the shielding materials should all be taken into consideration when calculating shielding requirements. Severe injury or death can result from improper radiation shielding.

For more detailed information contact the planning department or sales.

Consideration should be taken of the proximity to Magnetic Resonance Imaging (MRI) units or other magnetic field generating equipment. According to MRI manufacturers, linear accelerators and simulators should be located outside of the 100 μT (1 Gauss) magnetic field created by the MRI. A map of the magnetic field emanating from the MRI unit can be obtained from the manufacturer of the MRI unit.

REFERENCES

These support reference document and other more detailed documents are available from site planning or via your Varian PM.

[1] SD – AL – Shielding Information

[2] Varian Accelerator Pre-Installation Checklist

[3] SD - Mains Isolation Transformer for 380VAC sites

[4] SD – AL – Seismic Information

GLOSSARY AND ABBREVIATIONS

For more detailed information see http://patient.varian.com/us/glossary http://patient.varian.com/us/glossary

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2 VARIAN SYSTEM DIMENSIONS

GANTRY AND COUCH

The Halcyon system is a self-contained single unit. Patient positioning and user interface devices are integrated into the stand and gantry covers.

Figure 2-1 System Dimensions

Table 2-1 System Weights

Description Kg Lb Total System 4914 10834 Gantry and Covers 4530 9987 Couch 384 847

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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’s powered from the Main Disconnect Panel (MDP). See Figure 3-9 Generic Power Distribution and Table 3-2 System Power Requirements for details of the specific requirements and electrical connection required for the cabinet.

Figure 2-2 Console Cabinet Dimensions

Table 2-2 Console Cabinet Weight

Console Cabinet 330 726

CONSOLE FLOOR BRACKET

Varian provides a floor positioning bracket plate that must be attached to the floor under the Console Cabinet. This provides stops and locking pins to prevent the cabinet moving unintentionally.

Figure 2-3 Console Cabinet Floor Mount Bracket

Table 2-3 Floor Mount Bracket Weight

Console Bracket 23.4 52

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CONSOLE AND MONITORS

User interface components mounted on a desk in the control room.

• (2) 23" Monitors, standard

• Console dedicated keyboard

• USB keyboard and mouse, wired

Figure 2-4 Console Desk Layout

PRE-INSTALATION KIT (PIK)

The PIK consists of a Varian-provided Main Disconnect Panel and Relay Junction Box (MDP and RJB).

These components are typically ordered and shipped to site by the Varian PM for the customer to install prior to the Halcyon delivery. The Varian-supplied components must be installed in accordance with local code/regulations using Customer-provided and appropriately-sized mounting hardware engineered to support a combined maximum load as shown below.

2.5.1 MDP

The Halcyon Mains Disconnect Panel (MDP) is a Varian-provided custom panel that serves as the main power disconnect between the Halcyon system and the facility power source. This panel provides overcurrent protection and a panel mounted Emergency System Disconnect push-button providing immediate shut down of the entire system, complying with the NEC disconnect requirements. The standardized designs provide the customer, specifier, and installer several advantages by combining a variety of individual components into a single, pre-engineered, factory tested panel. The MDP panel is ETL recognized for compliance with approvals required by the NEC Articles 100 and 110-3.

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

• Splits the mains power into two independent switchable power outputs.

A 3-phase delta power output to the Halcyon Stand, which matches the incoming 3-phase voltage phase-to-phase (380–480VAC).

A single-phase power output to the Control Console in the range of 208–240VAC.

• Provides for various system safety features:

Overcurrent protection for the outputs Disconnect (non-emergency) Emergency Disconnect System Start

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Figure 2-5 Main Disconnect Panel (MDP)

Table 2-4 MDP Weight

MDP 82 180

2.5.2 RJB

The Varian-provided Relay Junction Box provides an interface with the Halcyon Accelerator via a factory assembled and tested control panel designed to provide a convenient, organized, central connection point for the system status warning lights, and door interlock switches, and remote emergency off push buttons. The panel includes wiring diagrams to enable it to be used as a central junction and control point simplifying the connection of the various systems. Multiple terminals are dedicated for connecting these devices. The Relay Junction Box is designed for wall mounting.

Figure 2-6 Relay Junction Box (RJB)

Table 2-5 RJB Weight

Relay Junction Box (RJB) 22.5 50

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ACCESSORIES KIT

The Halcyon system is supplied with a Phantoms Kit for physics QA testing. There are two versions of the Phantoms Kit – A Non-U.S. configuration which includes a Drum Phantom, Las Vegas Phantom, and Wire Phantom. The U.S. configuration includes the phantoms mentioned above plus one additional unit, the Phantom DVT VN 6/3/6cm. Provide adequate casework to store the phantoms when not being used.

Table 2-6 Phantom Dimensions and Weights

Description Width mm [in.]

Length mm [in.]

Height mm [in.] Kg Lb

Drum Phantom 552 [21.75"] 335 [13.25"] 245 [9.75"] 3 6.6 Las Vegas Phantom 140 [5.5"] 140 [5.5"] 25 [1"] 1.1 2.4 Wire Phantom 0.5 [0.2"] 100 [4"] - 0.006 0.2oz

Phantom DVT VN 6/3/6 (select configurations only) 160 [6.3"] 162 [6.5"] 170 [6.75"] 3.9 8.6

Figure 2-7 Drum Phantom

Figure 2-8 Las Vegas Phantom

Figure 2-9 Wire Phantom

Figure 2-10 Phantom DVT VN 6/3/6cm

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CCTV

A single “Live View” camera is included and mounted on the treatment couch. The Live View camera allows the therapist to maintain visual contact with the patient during treatment.

Figure 2-11 Couch Mounted Live View Camera

Additional CCTV cameras may be necessary to provide visual coverage in the treatment room for patient and personnel safety. Check with the Customer for CCTV camera requirements.

Varian offers a two-camera CCTV System as an optional purchase. Contact your Regional Sales Manager for more information.

• The CCTV housing is Customer-installed, mounts to a standard single gang electrical box.

• The CCTV camera is Varian-installed.

Figure 2-12 Optional CCTV Camera Mounts (Plan, Front and Side Views)

CAUTION Do not locate the CCTV camera in the primary beam path.

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CABLES

This section provides the point to point connection and the maximum cable length available for the Varian-supplied system cables. Refer to 3.2.11 cable containment for maximum containment lengths.

When calculating the containment length, required service loops should always be considered.

Table 2-7 Halcyon System Cables

Cable Id

Standard Cable

Length

Extended Cable

Length # of

Cables Start Finish

A 33m [108’] 46m [150'] 17

Y03 – Console Cabinet Y01 – Stand/Gantry

B 33m [108’] 46m [150'] 1

C 15m [49’] n/a 1 Y07 – MDP

D 62m [203’] n/a 1 Y01 – Stand/Gantry

Y07 – MDP

E 34m [111’] 46m [150'] 2 Y09 – RJB

F 15m [49’] n/a 10

Y03 – Console Cabinet

Y05 – Console DKB

G 3m [10'] n/a 1 Y08 – IEC Outlet

H 10m [32'] n/a 1 Network Outlet (by Customer)

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3 CUSTOMER REQUIREMENTS

SPACIAL

• The ideal ceiling height clearance is 274 [9'-0"] above finished floor.

• The minimums shown below DO NOT include Local Electrical or Regulatory Workspace clearance requirements.

Figure 3-1 Ideal Minimum Room Clearances

Contact your Varian Regional Planner for placement options that do not meet these minimum requirements.

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3.1.1 TREATMENT ROOM FLOOR AND PIT

The Treatment Room Floor Pit provides the required clearance needed for the rotating gantry and is the pathway that allows the electrical cables and cooling lines access to the Halcyon Stand.

All exposed concrete shall be suitably sealed before the Halcyon Installation.

Pit depth shall not vary more than 6mm [1/4"].

The finished floor shall be level to within ±3mm [1/8”] total of 6mm [1/4”] over a 160cm [5’-3”] radius as shown below.

When renovating an existing Varian accelerator, it is acceptable to use the existing BaseFrame pit with a width of 168 [5'-6"]. However, a 5 [2"], 45-degree chamfer must be cut along the top edge, on each side of the pit to allow clearance for the gantry rotation.

Figure 3-2 Treatment Floor Pit – Plan View

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Figure 3-3 Treatment Floor Pit – Section

3.1.2 FLOOR LOAD

WARNING

The Halcyon system 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 floor, walls and ceiling. For more detailed information contact your Varian PM or planning department.

The concrete slab below the Stand Base Pad (B) and Stand Leveling Foot (C) shall be no less than 30 [12"] thick. In addition, the area below the equipment mounting brackets shall be clear of rebar, conduits, water lines, voids, and other sub-floor structures that could interfere with equipment anchorage to a depth of 12 [5"] at the Stand Bracket (D) and 8 [3"] at the Couch Bracket (E) for the Non-Seismic, Varian-provided anchors.

Table 3-1 Stand and Couch Floor Loads

Description kN Lbf

A Couch Foot Pad, (3) Ø2.5 [1"], combined 4.2 945 B Stand Base Pad, Ø9 [3 9/16"] 17.1 3845 C Stand Leveling Foot, Ø6 [2 3/8"] 7.8 1754 D Stand Mounting Bracket n/a n/a E Couch Mounting Bracket n/a n/a

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Figure 3-4 Stand and Couch Floor Loads – Plan

Figure 3-5 Stand and Couch Floor Loads – Section

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3.1.3 PIT CABLE ACCESS DETAILS

The electrical cables must enter the left front or left rear face of the Floor Pit (E) while the cooling supply and return lines must enter the right rear face of the Floor Pit (W) within the designated area to avoid the rotating gantry. Figure 3-6 shows the maximum size for the three access areas.

Figure 3-6 Treatment Room Floor Pit Cable Access

3.1.4 SERVICE REQUIREMENTS

The Console Floor Bracket allows for proper positioning of the Console Cabinet and protects the cables from damage. Non-seismic anchors are provided to mount the bracket to the concrete floor to a depth of 8 [3"].

Figure 3-7 Console Cabinet Service Requirements

It is acceptable to install the floor bracket over finished flooring, if the flooring is equal to or less than 6mm [1/4”].

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3.1.5 CONTROL AREA LAYOUT

Typical setup shown below. Component positioning may vary per site specific conditions, consult with the Customer on desired layout and for additional space required.

Figure 3-8 Generic Control Console Layout

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ELECTRICAL

3.2.1 POWER REQUIREMENTS

Table 3-2 System Power Requirements

Input Voltage 400Y/231VAC to 480Y/277VAC (3-phase, neutral and ground [Parity-Sized]) 380VAC (requires an isolation transformer, output to 440Y/254V)

System Load 16 kVA @ 400-480V 50/60Hz (3-phase and ground, supplied from the MDP)

Console Load 2 kVA @ 208-230V 50/60Hz (1-phase, neutral and ground, supplied from the MDP)

Line Voltage Regulation

±10% maximum. This is the maximum allowable steady-state deviation from 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 ±3 Hz

Electrical Loads 3 kVA in Stand-By, 5 kVA Ready, 18kVA in Beam-On state. (Including console, 2 kVA)

Long-Time Load 18 kVA (Including console, 2 kVA)

Power Factor Equal to or greater than 75%, inductive load. The line-current waveform is non-sinusoidal

Source Impedance 135 mΩ @ 400Y/231V 145 mΩ @ 415Y/240V 163 mΩ @ 440Y/254V 194 mΩ @ 480Y/277V

Mandatory Grounding See 3.2.10 Dedicated Earthing\Ground Requirements

3.2.1.1 SOURCE IMPEDANCE

Maximum source impedance requirements for the 3-phases (and neutral) are shown Table 3-2 System Power Requirements for the 5 input voltage configurations. Lower voltages result in higher currents; therefore, the maximum impedance varies by voltage. Based on a worst-case power of 8 kVA per phase, a 2.5% maximum loss, and a low (-10%) input voltage.

The line currents are not balanced, with two phases supplying 5 kVA each, and one supplying 8 kVA (18 kVA total).

The maximum impedance includes any customer-provided impedances:

• A distribution transformer

• Field-connected wiring in the 3-phase path into the MDP

• Field-connected wiring in the 3-phase path from the MDP to the Halcyon Stand PDU.

For a given phase, the contributions of each of the above should be added together, and the sum should be less than the maximum Impedance.

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3.2.2 POWER DISTRIBUTION

Below is a typical layout of the power distribution.

Color key - Customer Supplied Purchasable Options Varian Supplied_

Figure 3-9 Generic Power Distribution

Ensure that all customer provided rough-in conductors includes a 4 meter [13'-0"] connection tail left coiled in the treatment room floor pit.

CAUTION

The mains power to the Halcyon 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.

CAUTION 400-480V Sites: Input to the MDP must be from a grounded WYE source

(400Y/231V to 480Y/277).

3.2.3 FIELD CONNECTED WIRE SIZES

3-phase wires should be sized to meet:

• Overall maximum source impedance requirements.

• Input and output circuit breaker ratings of the MDP are based on local regulations.

• Use Copper Conductors Only

• Ground and neutral wires should be in parity with the respective wires for each phase.

• Wires must be rated for 600V, with a temperature range of 90°C dry/75°C wet, minimum.

• Wires routing from MDP to the Stand/Gantry PDU (3~phase and ground) must be rated for wet locations and must route in a separately from other wires.

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Table 3-3 MDP Wire Size Ranges

MDP Input Terminals (CB1) 3~Phase, N, & G/PE

MDP Output Terminals (K1) 3~Phase & G/PE

MDP Output Terminals (K2) 1~Phase, N, & G/PE

0 AWG to 8 AWG 0 AWG to 8 AWG 10 AWG to 12 AWG

Table 3-4 RJB Wire Size Ranges

RJB Input Terminals

6 AWG to 18 AWG

Customer neutral connections may be terminated on the RJB neutral bar or by other means, per local electrical codes. The neutral bar is provided for convenience.

3.2.4 ISOLATION TRANSFORMER

An Isolation Transformer is required for sites with 380V input. In select countries where 380V is standard, the Isolation Transformer will be Varian-Provided. Please contact the Varian PM for more information. Refer to [3] SD - Mains Isolation Transformer for 380VAC sites.

3.2.5 POWER CONDITIONING REQUIREMENTS

The equipment is sensitive to line voltage variations and source impedance. A complete survey of the electrical supply should be conducted prior to the equipment installation and a copy of this survey should be sent to the regional Installation Project Manager for the equipment file. Isolation transformers and/or power conditioners are required where the electrical power requirements specified herein cannot be met.

Caution should be taken when powering the Halcyon from the same distribution source as elevators, HVAC equipment, and other phase-controlled loads, because of potential adverse effects on the operation of the x-ray equipment. The supply voltage waveform should be practically sinusoidal with less than 5% total harmonic distortion. Signals from devices that use the power line as a means of distribution can be the source of problems. Efforts should be taken to minimize such effects.

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, longer lasting or frequent transients occur as these can cause interruption of operation and/or equipment damage.

If an isolation transformer and/or power conditioner is installed, verify the output breaker size on this equipment and size the wiring accordingly before connecting to the Halcyon Mains Disconnect Panel (MDP).

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3.2.6 HALCYON MAINS DISCONNECT PANEL (MDP)

Mounting

• Locate the MDP panel in sight and within 3 meters [10'-0"] of the Halcyon Console Cabinet.

• The panel may be surface or semi-recessed mounted. For semi-recessed installations 20 [8"] of enclosure may be recessed in wall.

Conduit Access

• Conduits may enter or exit from top, bottom, or sides. Recommended location is incoming at the top and outgoing at the bottom. Rear conduits are not possible.

• A conduit punch is recommended for knockouts. The MDP sub-panel shall be removed during this process to avoid damage or debris contamination.

Labeling

• The panel should be conspicuously identified as “Mains Disconnect for Accelerator” per NEC.

This statement may vary per country/region. Consult the appropriate governing body.

• Adhere the Varian-provided self-adhesive “ARC FLASH” label to the front cover of the MDP (U.S.

installations only).

Figure 3-10 Generic Components within the MDP

3.2.7 POWER OUTLETS

Treatment Room

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

Control Area

• (1) IEC 60309, Blue, 230V 50/60Hz, 16A, 2-pole, 3-wire, grounding receptacle, Varian-provided, contractor-installed, powered from the MDP.

Locate to either side of the Console Cabinet, see Figure 3-7 Generic Control Console

Layout The line, neutral, and ground wires from MDP shall be 4 – 6mm2 [12 – 10 AWG] Rated for 300V minimum, with a minimum temperature rating of 90°C dry.

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

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Figure 3-11 Console Cabinet Connector - IEC 60309 Outlet

3.2.8 RELAY JUNCTION BOX (RJB)

The RJB is wall-mounted so access can be obtained at standing level from the finished floor. It is recommended that the RJB be located out of direct view and, in some instances, may be enclosed with casework. Verify that the location and clearances comply with local codes. Alternately, the RJB can be wall-mounted above the acoustical tile ceiling. Service access to the RJB must be maintained;

therefore, DO NOT locate the RJB directly above the Halcyon accelerator or any treatment room casework. The RJB may be surface-mounted or semi-recessed 10 [4"] of enclosure may be recessed in wall for semi-recessed installations.

WARNING Install the RJB at standing height from finished floor for service access.

3.2.9 DEDICATED EARTHING\GROUND REQUIREMENTS

The Halcyon Accelerator requires a Ground/Protective Earth (G/PE) circuit, as shown in Figure 3-12 Ground/Earthing Conductor Diagram. This circuit is part of the main power supply and provides grounding for the Halcyon Accelerator’s Gantry/Stand and the Console Cabinet. The minimum size of the copper wire ground conductor shall be equal in size (Parity-Sized) with the supply conductors.

Ground conductors shall be installed from the Stand to the Halcyon MDP and from the MDP to the facility’s main ground through the Hospital Grid System.

Ground/Earthing conductor must meet or exceed local code requirements and be equal in size (Parity-Sized) to the supply/power conductors, but no smaller than 16 mm2 [6 AWG].

Do not use water supply piping for ground. The equipment is sensitive to electrolysis from water pipe grounding.

• Provide one G/PE conductor from the incoming mains power to the MDP.

• Provide one G/PE conductor from the MDP to the Stand PDU.

• Provide one 6 mm2 [10 AWG] G/PE conductor from the MDP to the Halcyon Console Cabinet.

This cable shall be 15 meters [50'-0"] in length and be terminated with a 6mm ring lug.

Provide a 3 meter [9'-0"] minimum "service loop" at the rear of the Console Cabinet.

• Provide one G/PE conductor from the main ground source to the RJB and terminate with a 6mm ring lug.

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An optional 6 mm2 [10 AWG] G/PE conductor can be connected from the MDP (ground bar TBG3) to ground the Control Equipment Pull Box (if present).

Figure 3-12 Ground/Earthing Conductor Diagram

3.2.10 CABLE CONTAINMENT

The customer is responsible for permissibility of the installation at site with respect to applicable local or regional standards. This might affect the choice of cable routes, number of conduits, specifications of mains power and data cables, and the choice of installation locations of system components.

The customer must be aware that fire protection engineering aspects (plenum rating) may be affected when installing cables and system components.

• Ensure all components are placed so that the shortest cable length is sufficient.

• All conduits run underground shall be dry and watertight. Therefore, all PVC pipes must be glued together, and metal conduits must be properly sealed.

• All conduits must be terminated with insulating bushings or similar means to protect cables from abrasion.

• Provide adequate clearance for typical conduit radius of six times the diameter.

• Conduit bends shall not exceed 270 degrees per cable run.

• Route all room penetrations as perpendicular to the isocenter as possible to avoid radiation scatter.

Verify all room penetrations with the Physicist of Record.

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Figure 3-13 Containment Identification

Table 3-5 Minimum Recommended Containment Sizes

Cable Id

Maximum Length

Minimum Size Ø Quantity Start Finish

A 38m [125'] 100mm [4”] 1

Y03 – Console Cabinet Y01 – Stand/Gantry

B 38m [125']

50mm [2”]

C 11m [36'] 1 Y07 – MDP

D 57m [187'] 1 Y01 – Stand/Gantry

Y07 – MDP

E 41m [135'] 1 Y09 – RJB

F n/a n/a n/a

Y03 – Console Cabinet

Y05 – Console DKB

G n/a n/a Y08 – IEC Outlet

H n/a n/a Network Jack (by Customer)

The above information is the minimum size required to contain the cables and provide separation requirements for functional operation. Other containment options are acceptable to achieve these system interconnections in existing or new installations, the planning department can offer more information on these options.

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Table 3-6 Customer Specified Containment Sizes

I n/a Per Code (32 mm min.) 1

Y07 – MDP

Y01 – Stand/Gantry

J n/a Per Code 1 Y08 – IEC Outlet

Install the Varian-provided 3 meter [10'-0"] long, 32mm diameter, flexible metal conduit in the treatment room floor pit to the conduit containing the 3-phase and ground wires from the MDP to the Stand/Gantry PDU (Power Distribution Unit).

Other customer required containment considerations:

• Door Interlocks

• Warning Lights

• Emergency Off

• Experimental Access (Physics Q/A Port)

3.2.11 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 agencies requirements.

A – Emergency Off Switches B – Door Switches C – Warning Lights power in D – Warning Lights

Figure 3-14 Interconnection Wiring Diagram – Safety and Warning Devices

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3.2.11.1 EMERGENCY OFF SWITCHES

Emergency-Off (EMO) switches remove power from the accelerator. There are EMO switches built into the accelerator Stand (x2), Couch (x2), and Console (x1). Additional, Customer-provided, EMO switches may be required in the treatment room. Verify all requirements with regional regulatory agencies.

Provide an Allen-Bradley 800T-FX6AV or equivalent, two-pole, dry contact type with manual reset.

Each switch shall be wired in series to two separate parallel circuits. Both contacts shall be normally closed (NC). Locate switches to avoid inadvertent contact, such as by gurneys or carts.

3.2.11.2 DOOR INTERLOCK SWITCHES

Two safety door interlock switches are required for all installations. Provide two door switches, a 48VDC (primary) and 24VDC (secondary). The switches must open/close within 500ms of each other to avoid system faults. They are normally open type switches and are used to ensure the room doors are closed during Halcyon operation. Verify with the door manufacturer the type of switches supplied with the door or provide compatible type. These door switches should be connected to the Primary and Secondary Door Interlock inputs in the RJB. The switches must be capable of switching up to 80V, 500mA. The primary door circuit is 48V/250mA (nominal), and the secondary 24V/1mA (nominal).

If a second vault door is present, a second set of (primary and secondary) door interlock switches may be installed. If installed, they must be wired in series with the main door interlock switches and must also open/close within 500ms of each other to avoid system faults.

3.2.11.3 WARNING LIGHTS

System warning lights are customer-provided fixtures that are required in the treatment room, and/or over the door, and/or at eye level adjacent to the door 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 a Halcyon room. They are usually located adjacent to the emergency-off switches. Verify local requirements with regional regulatory agencies.

Each of the three Warning Light circuits has a maximum incandescent lamp load of 60 watts. If a greater load is required, these circuits can be used to control separate, customer-provided relays.

Alternately, LED fixtures can be substituted. Fluorescent fixtures are not approved.

Table 3-7 Warning Lights

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

Beam “ON” Light Illuminates during treatment beam (MV), mandatory. Minimum, one light located above the treatment room entry door.

Beam “OFF” Light Illuminates when the accelerator is not in a radiation-generating state, this is not a mandatory warning light.

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

X-Ray “ON” Illuminates during imaging beam (KV), mandatory for accelerators with On-Board Imaging. Minimum, one light located above the treatment room entry door.

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3.2.11.4 OPTIONAL SAFETY DEVICES

The following optional safety devices are Customer-provided and installed.

Last Man Out (LMO) An LMO switch may be installed at the customer’s discretion or if required by regional regulatory code. Provide a switch that will control the primary and secondary door interlock switch signals to the RJB.

• The primary and secondary door interlock signal at the RJB shall remain open until the LMO is pressed and the treatment room door is closed, in that order.

• Closing the treatment room door alone without pressing the LMO switch first shall not result in the treatment room door circuits being closed at the RJB.

• Each time the treatment room door is opened, the circuit controlling the treatment room door signals shall reset to the open states.

• Timeouts and audible warnings shall be implemented as required by the LMO manufacturer.

Light Curtain Optional sensing method to interlock the beam if it is activated.

Emergency Disconnect This is a single switch, mounted in the control area, regardless of machine mode, when activated it removed all power from the machine.

3.2.12 NETWORK

• (1) Network outlet next to the Console Cabinet (Y01) required, (3) additional outlets (recommended for printers and additional customer supplied computers).

• Cat 5e cable (minimum), CAT 6 (recommended).

• Bandwidth 100Mbps, full duplex 100BASE-T (minimum), 1Gbit/s or higher (recommended).

• The RJ-45 jack must meet TIA/EIA-568-A wiring pattern.

• Varian recommends isolating the Oncology domain from the Enterprise Network.

• The Console Cabinet (Y01) requires a static IP address.

• Refer to Varian network configuration guide - MICAP, contact Varian PM for document details.

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.

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PLUMBING

Table 3-8 Coolant Requirements and Water Heat Loads

Ideal Coolant Flow 18° C. at 12 LPM [65° F. at 3.2 GPM]

Flow Range 7 - 23 LPM [2 - 6 GPM]

Incoming Coolant Temperature Range 10 – 25° C [50 - 77° F]

Glycol Content of Coolant Not to exceed 50%

Minimum Operational Heat Load (required, 24 hours) 1kW (3,414 Btu/Hr

Normal Treatment Cycle Coolant Heat Load 2.2 kW (7,511 Btu/Hr)

Maximum Coolant Heat Load (Beam-ON) 7 kW (23,900 Btu/Hr)

Pressure Drop 2.2 kg/cm2 [32 PSI] (under maximum heat load conditions)

Maximum Inlet Pressure 7 Bar [100 PSI]

Average Water Temperature Rise during all states (w/closed bypass valve). 16° C [27° F]

Typical incoming coolant temperature range, if lower temperatures are used, a psychrometric chart must be consulted to determine the dew point in the facility. If the inlet temperature is below this dew point condensation could form resulting in equipment damage.

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3.3.1 CHILLED WATER

The cooling water requirement can be satisfied with a Closed-Loop system (Dedicated Chiller Unit or Central Plant Chilled Water) or a One-Pass system (Domestic "City" Water).

• Chilled water supply must not exceed 7 Bar [100 PSI], controlled by a regulator (A)

• Terminate piping with isolation valves (C) and a 25 mm [1"] FNPT (D).

• An optional machine bypass valve (G) may be installed.

• Provide a minimum of one flow meter (B) on supply or return line to monitor flow rate.

• Copper piping is recommended, a filter/strainer should be installed for dissimilar metals.

• Piping should not run directly above the accelerator.

• A Varian-provided, Contractor-installed flexible hose kit is used to connect the piping to the accelerator.

• A bypass valve is located inside the system stand (E). this valve is open for Closed-Loop systems and closed for One-Pass systems.

• A modulating control valve (F) is located inside the system stand (E) maintains an internal coolant loop temperature of 30°C [86°F]

Customer Responsibility Varian Responsibility

Figure 3-15 Cooling Schematic

If a Closed-Loop system is designed with domestic water backup, it is recommended to provide a means to notify the user that the accelerator bypass valve should be closed in the event emergency backup One-Pass system is used.

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3.3.2 FLOOR PIT COOLING LINE ACCESS

• Extend two 2.5 [1"] cooling lines into the Treatment Room Floor Pit and terminate with a 1"

FNPT bushing and plug, refer to Figure 3-17 Cooling Line Access Plan

• Install shut-off valves for the chilled water supply and return lines on the rear wall behind the Stand, refer Figure 3-18 Cooling Line Access Section

Figure 3-16 Cooling Line Access Plan

Figure 3-17 Cooling Line Access Section

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3.3.3 COOLING WATER QUALITY

External cooling water can be supplied from a centralized plant or Closed-Loop system this is the preferred solution. The option of a One-Pass (city water) can be integrated using bypass values as a backup only. The design could also be a combination of methods to provide greater resilience and redundancy to the final solution, this detail design would be the responsibility of the local contractor.

Table 3-9 Minimum Coolant Water Quality

Base Quality Clean clear, non-turbid, waterac. It should be treated with inhibitor in a Closed-Loop systemb

Values for One-Pass (city water) cooling shown in ( )

Value Units

Pathogens, Coliform Bacteria Nil cfu/ml

Heterotrophic Plate Count (HPC) <100 (<100) cfu/ml

Acidity 7.5 – 10 (7.0 – 9.0) pH

Electrical Conductivity >2000d (>250) µS/cm

Total Dissolved Solids >1300d (>160) Mg/L

Total Chlorides as Cl >150 (>50) Mg/L

Total Hardness as CaCO2 >150e (>75e) Mg/L

a. City water is intended solely as a backup supply and is not recommended for permanent use as the external coolant source.

b. Facility Water is preferred for permanent use as the external coolant source.

c. Experience has shown that some local potable water supplies have caused excessive corrosion and frequent replacement of the internal heat exchanger.

d. Facility Water has higher conductivity and total dissolved solids limits because added corrosion inhibitors would raise these control measures. In a small percentage of systems, the conductivity could be lower based on the type of corrosion inhibitor used.

e. For systems where, soft water or purified water is used for makeup, lower total hardness is acceptable if there is sufficient corrosion inhibitor in the system.

When glycol is added to external facility water, propylene glycol is preferred (due to its better environmental safety record compared to other glycols) at a strength not to exceed 50% by volume (v/v).

External water (from city or facility) will require secondary disinfection (i.e., in addition to any bleach/chlorine/chloramine reserve present) to avoid biofilm formation in the Accelerator's heat exchanger. Seek advice from a water treatment professional.

The water coolant specification in this section does not apply to the Accelerator's internal coolant water loop. Contact the Varian Help Desk at 1-(888)-Varian5 (827-4265) for information.

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ENVIRONMENTAL SPECIFICATIONS

• Ambient temperature range - 16° to 27°C [60° to 80°F].

• Humidity range - 30% to 75% Relative Humidity, Non-condensing.

• Maximum altitude – 2000 m [6562 ft]

3.4.1 VENTILATION

Accelerators will produce detectable levels of ozone under certain conditions. Four to six air changes per hour are normally required to maintain undetectable levels, normal ventilation typically accomplishes this. Fresh-air should be used as part of the design. Provide positive air pressure in the vault to assist in holding swing-type doors closed.

Table 3-10 Gantry Stand Heat Load

Treatment Room – Stand/Gantry (Y01) Halcyon Condition kW BTU/Hr During Beam-On State 6.0 20,487 During all other states 1.0 3,413

Table 3-11 Console Cabinet Heat Load

Control Room Description kW BTU/Hr Control Console Cabinet (Y03) 1.1 3,770 Optional ARIA workstation and monitor 0.5 1,707

VIBRATION

The Halcyon system is immune to vibration, but consideration should be given to selected locations where local equipment could causes excessive vibration. Most installations are at or below grade so vibration is normally not an issue. Equipment locations that should be considered in the overall design;

large compressors or generators, elevators, and train lines. The total allowable patient-field position error is specified as 0.1mm (100 micron) zero-to-peak. Contact your Varian Regional Site Planner for more information on assessing site-specific situations.

ACOUSTIC

There are no recognized acoustical standards for therapy rooms. Varian has encountered no acoustical problems when the Modulator is located in the treatment room. The patients are in the room for a very short time and observations indicate that some seem reassured by the changing sound levels as the machine goes through its cycles.

Table 3-12 Acoustic Levels

Location Condition dBA

Console Cabinet Control Console Cabinet @ 1m 53 Isocenter Beam-On State 49

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FINISHES

3.7.1 FLOORING

The Halcyon system contains electronic components that are sensitive to electrostatic discharge (ESD).

Vinyl composite tile (VCT) or vinyl sheet goods (VSG) flooring in the treatment room and control area must be considered “static dissipative” as outlined in EOS/ESD S7.1 and ANSI/ESD S20.20 or equivalent.

• Resistance in the range of 1M - 1000M Ohms [10e6 - 10e9] Carpet can make gurney movement difficult. In addition, liquids and stains on carpeting can be difficult to clean, thereby posing an infection control risk. However, if carpet is selected, the electrostatic propensity must not exceed a 2.0 kV rating at 20% relative humidity when measured as outlined by the methods in AATCC-134 or equivalent.

Whatever flooring type is selected, consideration must be given to the infection control regimen, to ensure that the static dissipative properties remain intact over time. It is recommended that the final floor covering be installed before the equipment delivered, refer to Section 4.4.

DO NOT install flooring in the hatched areas to either side of the floor pit. The Stand and Couch Mounting Brackets must be installed directly on the concrete, for accuracy the couch bracket cutout will be performed during installation.

Figure 3-18 Flooring Voids at Stand

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3.7.2 CEILING

There is no finished ceiling type specification. However, experience has shown the benefit of a 60 x 120 [24” x 48”] or 60 x 60 [24” x 24”] lay-in acoustical ceiling tile. Among its benefits are easy access to above ceiling structures/systems and cables, low repair and modification cost, acoustical attenuation, and the aesthetic benefits of modern ceiling grids and tiles.

3.7.3 ACCESSORIES

It's recommended that custom cabinetry be built to store accessories for the accelerator and patient immobilization devices. Due to differences in treatment practices, the exact quantity and types of accessories varies with each site, refer to your Varian PM and verify requirements and storage preferences with the Customer.

3.7.4 FIRE PROTECTION

Sprinklers inside the treatment room are discouraged. Their discharge or inadvertent leakage into the couch pit or into the Stand generate expensive repairs with extended shut-downs. Some jurisdictions allow substitution of Type I construction for fire protection. Detectors are strongly recommended and normally adequate if a type “C” fire extinguisher is available in the treatment room. Heat detectors or photo-electric smoke detectors are preferred because ionization-type detectors can, under certain circumstances, give false alarms. If fire sprinklers are required by local authorities, sprinkler heads should not be located above the equipment. A system, valved and controlled by the smoke detector (dry pre-action) can be incorporated so that sprinklers are wet only upon specific need. Semi- or fully recessed, high-temperature heads are recommended in wet systems. The safety of non-ambulatory patients should be reviewed if a chemical system is considered. Verify all regional regulatory code

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4 PROJECT MANAGEMENT

RESPONSIBILITIES

All pre-installation dates and considerations are individually scheduled by the Varian Project Manager, based on agreement between the customer and project manager and communications with Varian Planning and Sales. The Project Manager will engage the customer with regular communications throughout all phases of the project. In addition, the Project Manager typically performs site visits to help answer questions and observe construction progress. Site visits are commonly held for the Initial Site Meeting/Project Kick-off and the Construction Completion/Pre-Installation Final Inspection. This final visit typically occurs 7 - 10 days prior to the RIG date to verify 100% completion as defined by the Halcyon Final Checklist.

= Critical STOP/GO Inspections = Varian Install dates to suit customer program = Work by others

Table 4-1 Typical Project Schedule (Estimated)

Task (Estimated weeks) 1 … 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 …

Place machine order X Design/Construction (varies) MCB and RJB delivered & fitted Pre-Installation Inspection Machine delivery (weekend) Machine RIG (weekend) System Installation Machine acceptance

OBJECTIVES

The items listed below must be completed before the Final Inspection from Varian can be performed and the equipment released for delivery. Varian’s installation timeline is based off all these items being completed as a minimum at this Inspection. A complete “Varian Accelerator Pre-Installation checklist” can be provided by the Varian PM.

• Varian work area is finished to a clinical standard, dust free with no other trades having access.

The area shall be isolated from any other construction area with a solid barrier.

• The customer has applied for obtained and signed all licenses and approvals required for this installation.

• A clear rig path exists – ensure all clearances and load bearing from the unloading/staging area to the vault meet the minimum requirements.

• High speed internet access, live hospital network with record and verify system available.

• MICAP survey has been completed and submitted.

• Permanent power is live and in-place. All electrical requirements are completed including, conduits, wiring, circuit breakers and power conditioners.

• Chilled water supply at the accelerator, tested and fully operational.

• All safety related items are installed and connected.

• Treatment and control room HVAC system is tested and fully operational.

• Flooring and casework has been completed or prepared as previously agreed.

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MDP AND RJB

Sub Project No. 1 This document’s…