36C24619B0021-0004007.pdf

INSTALLATION

DATA

PACKAGE

Section Four General Information and VariSource™ ,GammaMed Equipment Information

"VariSource and GammaMed" are trade names for Varian high dose rate remote afterloaders.

English Version

June 2003

Introduction to the Varian Installation Data Package (IDP)

April 2002 inside cover.doc

Printed Installation Data Package or Digital Installation Data Package (Adobe© Acrobat .PDF format)

The Varian Installation Data Package (IDP) consists of several sections. Each section contains detailed information about Varian equipment as listed below:

Section 1 Clinac 2000C/R, 2100C(/D), 2300C/D, 21EX, 23EX Equipment Information and General Information Section 2 Clinac 600C(/D), 4EX, 6EX Equipment Information and General Information Section 3 Acuity Simulator Equipment Information and General Information Section 4 VariSource Equipment Information and General Information Section 5 Treatment Planning -VARiS and Eclipse System Equipment Information and General Information Section 7 Silhouette Edition Clinac Equipment Information and General Information

To obtain a printed copy of any of the Varian IDP's, contact the Varian Planning Department at the address below.

Digital Drawing Files

Available from the *Varian Web Page are Autocad .DWG and .DXF files for all sections of the IDP. These IBM PC-compatible files contain the Printed IDP details that are most useful for incorporation into the Architect's contract documents.

A Printed Installation Data Package or Digital Installation Data Package are required to use the Digital Drawing files.

Included in each self un-archiving file is the complete keynote database saved as a comma-delimited ASCII text file that can be inserted into most word processors, spreadsheets and databases. Each detail, as designated by a letter in the lower left corner, is saved in a separate file for easy insertion into the Architect's documents. A CAD file name can be found in the lower right corner of each detail. These files are provided by Varian to simplify the design and drafting process and must be modified by the Architect and Engineers to satisfy all site-specific conditions and regional regulations.

* Download Autocad DWG and DXF files from: http://www.varian.com/onc/ -support -architectural support

Limitation of Liability Every effort has been made to keep these files consistent with the documents in the IDP. These disks and files are provided "as is" without warranty of any kind, either express or implied. The Architects and Engineers of Record to reflect any and all site-specific conditions and regional regulatory agency requirements shall modify these files. Varian shall not be liable for the accuracy or completeness of the files on these disks, any documents that include portions of them or any damages, direct, indirect, incidental or consequential, including damages for any lost profits or project delays that result from the use of the files included herein.

Contact the Varian Planning Department if you have questions.

Varian Medical Systems Planning Department 3100 Hansen Way, M/S E-165 Palo Alto CA 94304-1038 Phone (800) 278-2747 (650) 424-5945 Fax (650) 424-6252

E-mail - planning@varian.com

*Download Autocad DWG and DXF files from: http://www.varian.com/support -architectural support

Installation Data Package Section Four

June 2003 1102292 Page 4.01

Varian VariSource™, GammaMed High Dose Rate Remote Afterloader Equipment Information

Doc # Page #

Table of Contents ..................................................................................................................................... 1102292........................4.01

Section Notes ............................................................................................................................................ 1101802........................4.02

General Information

Introduction to the Installation Data Package (IDP) ............................................................................ 1100501........................0.01

Terminology for Accelerator, Simulator and Remote Afterloader..................................................... 1100503........................0.02

Typical Design and Installation Timeline.............................................................................................. 1102372........................0.03

Typical Department Plan.............................................................................................................................862455........................0.04

Drawings

Typical Room Shielding Tables...............................................................................................................1102294 .......................4.21

Typical Room Isometric.............................................................................................................................1102295 .......................4.22

Typical Room Configuration.....................................................................................................................1102284 .......................4.23

Typical Control Equipment Casework....................................................................................................1102283 .......................4.24

Typical Closed Circuit Television (CCTV) System ...............................................................................1102286 .......................4.25

Cable Access Diagram .............................................................................................................................1102398 .......................4.26

Typical Lighting, Safety and Service Details ..........................................................................................1102297 .......................4.27

Interconnection Wiring Diagram ..............................................................................................................1102290 .......................4.28

Pre-Installation Checklist..........................................................................................................................1102371 .......................4.29

Shipping List................................................................................................................................................1102373 .......................4.30

Varian-Supplied Component Information Table...................................................................................1102399 .......................4.31

Index

Page Index

"VariSource and GammaMed" are trade names for Varian high dose rate remote afterloaders.

Section Four Notes

June 2003 1101802 Page 4.02.1

Information and Support

This is not the complete Installation Data Package (IDP).

This section describes only information on specific equipment facility requirements for Varian VariSource, GammaMed. Refer to the "General Information" section for an overview of the IDP and glossary of accelerator terminology. For more information, contact your nearest regional support office or Varian's main Planning Department at:

Varian Oncology Systems Marketing Planning Department 3100 Hansen Way, M/S E-165 Palo Alto, CA 94304-1038

(800) 278-2747

(650) 424-5945

(650) 424-6252 Fax http://www.varian.com/support

Equipment Options and Additional Services

To simplify the design process, we suggest that the Architect and Customer determine, as early as possible, all optional equipment configurations ordered or planned for the future. Any Varian-provided third-party vendor items or services should also be discussed.

Equipment

VariSource 200 System .............................(yes/no) VariSource 200T System...........................(yes/no) GammaMed Plus........................................(yes/no) GammaMed Plus 3/24...............................(yes/no)

GammaMed Trolley....................................(yes/no)

Optional Items/Services

CCTV System ..............................................(yes/no) Intercom System .........................................(yes/no) Radiation Monitor…………………………(yes/no) Radiation Safety Accessory Kit ................(yes/no)

IDP Distribution

All participants in the process of designing a VariSource, GammaMed facility should be generally familiar with the entire IDP. As the central project manager, the Architect should control the distribution of all IDP materials. Below is an outline of the drawings in this section to which various parties should pay particular attention on a typical project:

• Physicist - Pages 4.22 and 4.24.

• Architect - This entire section.

• Electrical Engineer - Pages 4.25, 4.26, 4.27, 4.28, 4.29, 4.30 and the Varian-Supplied Component Information Table.

• Mechanical Engineer - Pages 4.25, 4.31 and the Varian-Supplied Component Information Table.

• Structural Engineer - Pages 4.25, 4.29 and the Varian-Supplied Component Information Table.

• Contractor - To insure that accurate, project-specific information is used for construction, the Contractor should obtain all information from the Architect's construction documents.

Typical Duties of the Parties

To help assure a trouble-free project, good communications between the Customer, Architect and Contractor, and a clear agreement with the assignment of responsibilities involved in the construction or remodeling of the VariSource, GammaMed room, we suggest inclusion of the following material in the appropriate sections of the Architectural Specification. Refer to the Customer/Varian Terms and Conditions of Sale and the Customer Purchase Order for a complete description of project-specific responsibilities.

The Customer shall:

• Provide source license and documentation pursuant to Euratom Council Regulation No. 1493/93 authorizing shipment of radioactive substances between member states where applicable.

• Provide As -Built Documentation (existing facility).

• Provide supervision and temporary services/facilities.

• Verify that the Varian Pre-Installation Checklist is completed.

• Provide equipment and material storage during construction.

• Verify Installation of VariSource, GammaMed Pre-

Installation Kit.

• Provide unloading space.

The Architect shall:

• Provide complete Architectural & Engineering

Construction Documents for review.

• Provide Construction Documents.

• Provide Construction Regulatory Agency approval.

• Monitor conformance of the construction to the

Construction Documents.

• Provide As -built documentation.

The Contractor shall:

• Provide structural alterations as required.

• Provide casework, cabinetry, doors or other millwork.

• Provide shielding and shielded door.

• Provide mechanical/electrical systems as required for room occupancy, including plumbing, fire protection systems, HVAC, lighting and power distribution.

• Provide and connect electrical utilities, as required for the VariSource, GammaMed operation, to an interface point.

• Provide CCTV, Radiation Monitor, Intercom and Equipment Selector Switch as selected by Customer.

• Provide periodic and final cleanup.

• Remove Varian shipping crates.

• Pull Varian interconnect cables, and mount Varian supplied enclosures.

• Provide and pull network cables, where required.

Section Four Notes

June 2003 1101802 Page 4.02.2

• Maintain VariSource, GammaMed room and control equipment area in a dust free and vandal-proof condition during VariSource, GammaMed assembly and run-up.

Varian shall:

• Provide VariSource, GammaMed equipment.

• Provide the VariSource, GammaMed Pre-Installation

Kit.

• Provide planning assistance.

• Provide Construction Document review.

• Provide periodic on-site inspection of work by others.

• Provide assembly and run-up.

Regulatory Requirements

• As stated in the Terms and Conditions of Sale, the Customer is responsible for obtaining all permits and for meeting all requirements relating to applicable state and local codes, registrations, regulations and ordinances affecting the Varian equipment.

• The radiation control regulations in several regions prohibit Varian from delivering equipment until the Customer can provide evidence of meeting certain requirements. Varian is often required to verify that Customers located in these regions have either licensed or registered their equipment and/or registered their facility before a machine can be delivered, installed, or released for clinical use.

Customers should obtain their license or file their registration in a timely manner to avoid delivery and installation delays which can occur if these requirements have not been met.

• Varian must also verify that Customers located in certain regions have had their facility plan review approved by the regional radiation control agency before the delivery of equipment can be authorized.

Customers are encouraged to submit their plan review to the appropriate agency early enough for Varian to verify compliance with these requirements well in advance of a scheduled delivery date.

• Questions about regulatory requirements should be directed to your regional radiation control agency.

Documentary evidence of compliance with the above requirements or questions should be addressed to the Varian Regulatory Affairs Department.

Varian Medical Systems 3140 Hansen Way Palo Alto, Calif. 94304

Radiation Regulatory - (650) 424-6662 Regulatory Compliance - (650) 424-6398

• In accordance with Occupational Safety and Health

Administration (OSHA) regulations, Varian provides with each Clinac, Acuity, VariSource or GammaMed a Material Safety Data Sheet (MSDS) packet which identifies hazardous substances used in these machines. If you require an advance copy of the MSDS packet for your machine, please contact your regional District Sales Manager or the Varian Safety Administrator at the following address:

Varian Safety Administrator Oncology Systems 911 Hansen Way Palo Alto, CA 94304

Introduction to the Installation Data Package (IDP) General Information

February 2003 1100501 Page 0.01.1

Information and Support

The purpose of the IDP is to aid Customers, Architects, Engineers and Contractors in their understanding of Varian equipment requirements and facility design issues.

The IDP consists of equipment sections as listed below:

Section 1- Clinac 2000C/R, 2100C/D, 2300C/D,21EX,23EX

Section 2- Clinac 600C(/D),6EX,4EX Section 3- Acuity Simulator Section 4- VariSource, GammaMed Section 5- Treatment Planning VARiS and Eclipse Section 7- Silhouette Edition Clinac

For more information, contact your nearest regional support office or Varian's main Planning Department at:

Varian Medical Systems Planning Department 3100 Hansen Way, M/S E-165 Palo Alto, CA 94304-1038

(800) 278-2747

(650) 424-5945

(650) 424-6252 Fax http://www.varian.com/support

Digital IDP

Available from the *Varian Web Page are Autocad .DWG and .DXF files for all sections of the IDP. These IBM PC-compatible files contain the Printed IDP details that are most useful for incorporation into the Architect's contract documents. A Printed Installation Data Package or Digital Installation Data Package are required to use the Digital Drawing files.

Included in each self un-archiving file is the complete keynote database saved as a comma-delimited ASCII text file that can be inserted into most word processors, spreadsheets and databases. Each detail, as designated by a letter in the lower left corner, is saved in a separate file for easy insertion into the Architect's documents. A CAD file name can be found in the lower right corner of each detail. These files are provided by Varian to simplify the design and drafting process and must be modified by the Architect and Engineers to satisfy all site-specific conditions and regional regulations.

* Download Autocad DWG and DXF files from:

http://www.varian.com/ support

Keynotes

The drawings in the following section utilize keynotes to describe all non-graphic information. To simplify their use, these keynotes have been organized into the following general categories:

General Notes

10 General Notes

Layout Notes

20 General Layout Notes 21 Equipment Layout / Clearances 22 Rigging 23 Dimension Descriptions 24 Installation Notes

Finish Notes

30 Finishes 31 Control Equipment Casework 32 Room Storage Casework

Structural/Anchorage Notes

40 Base Frame Installation / Anchorage 41 Component Anchorage Brackets 42 Laser Positioning Light Mounting

Mechanical Notes

50 General Mechanical Notes 51 Plumbing 52 Coolant System 53 Ventilation 54 Compressed Air System 55 Fire Protection

Electrical Notes

60 General Electrical Specifications 61 Laser Positioning Lights 62 Room Lighting 63 Safety Device Systems 64 Cable Access Runs 65 Pull / Junction Boxes 66 Circuit Breakers / UVRs 67 Communications 68 Misc Electrical Components 69 Power Receptacles / Switches

Shielding Notes

70 Radiation Shielding 71 Other Shielding

Room Description Notes

80 Room Labels / Descriptions

Varian Component Dimensions, Weights and Other Information

Information regarding Varian-supplied components, such as weights, dimensions, wattage and decibel output levels, is located on the Varian-Supplied Component Information Table at the end of this section.

The Planning Department provides:

Standard and Supplemental Data

Installation Data Package (IDP) - This package contains equipment and facility information required by the Customer, as well as the Customer's Architect, Engineers and Contractor. The IDP outlines the facility requirements to insure the quick and efficient installation of Varian equipment. All information provided in the IDP shall be processed by the Customer's Design Professionals for

February 2003 1100501 Page 0.01.2 local regulatory agency and site-specific facility requirements. This information must then be incorporated into the Construction Documents. Since Varian equipment does not require modification to suit specific sites and all facility requirements are defined in the IDP, Varian does not provide shop drawings.

The Planning Department provides:

Supplemental Information - There are many supplemental documents available from the Planning Department's web page www.varian.com/support.

Typical documents available include:

• AutoCAD drawing files.

• Sample Seismic Calculations - These are available on request for all Clinac and Acuity models. These studies analyzes the forces acting on the equipment's base frame connection to the floor.

• Specialized shielding documents.

• Third Party specification documents.

Site-specific Support

All site-specific documents supplied by Varian are provided to aid the Customer during the facility design and construction document preparation processes. These documents are intended to supplement the IDP with site-specific recommendations only. They do not provide additional engineering information and are not construction documents. All information provided in the IDP shall be processed by the Customer's Design Professionals for local regulatory agency and site-specific facility requirements. This information must then be incorporated into the Construction Documents. Since Varian equipment does not require modification to suit specific sites and all facility requirements are defined in the IDP, Varian does not provide shop drawings.

Preliminary Department Plan Review – The planning Department will require a preliminary plan of the proposed department. Upon receiving the plan we will comment on the following: Circulation paths, rig paths, special relationships, control area size and configuration, accelerator and or simulator room size and configuration.

Upon request Varian can supply to our Customer or the Customer’s Design Professionals examples of various department floor plans ranging in size and configuration including one or multiple vault layouts.

Proposal Drawing - This drawing shows the equipment in the proposed room in both plan and cross-section. It includes a shielding analysis of the equipment room with the proposed equipment. Any recommended additions to existing shielding are shown. It also includes recommendations for a schematic console layout, cabinets, sinks and support equipment as well as references to the appropriate sections of the IDP for these items. Where there are required site-specific variances to the information in the IDP (usually on existing facilities), additional information may be shown on this drawing. The

Planning Department requires a dimensioned floor plan (or an extracted DWG or DXF CAD file of the specific area) room section, existing or proposed shielding layout and existing utility information.

Site Visit by Planning - In special circumstances, a Planning Department or other Varian representative will visit the site to review the facility or to consult with the Customer, Architect, and Engineers.

Construction Document Review - The Review of the Customer's construction documentation is usually Planning Department's final contact with the project. In this review the architectural and engineering documents are checked to determine that the required additions or modifications to the facility are appropriate for Varian equipment. Varian checks only for those items that affect the operation of our equipment. Varian does not check for compliance with various regulatory agency requirements.

The review is made to the extent that the submitted plans allow. This does not include verification of the adequacy of radiation shielding, which must be approved by the facility's Physicist of Record. The review does not constitute nor imply approval of either the architectural or engineering documents. Varian expressly denies any responsibility for the accuracy or adequacy of the construction documents prepared by the Customer's design consultants.

North American Architectural Planning Support

To obtain further Architectural support or information contact:

Western Region - Main Office Varian Medical Systems Planning Department 3100 Hansen Way, M/S E-165 Palo Alto, CA 94304-1129

(800) 278-2747

(650) 424-5945

(650) 424-6252 Fax http://www.varian.com/support

Central Region Varian Medical Systems Planning Department 403 International Parkway, Suite 503 Richardson, TX 75081

(972) 238-1855

(972) 644-2681 Fax

Northern Region Varian Medical Systems Planning Department 2397 Hawthorne Drive Yorktown Heights, NY 10598

(914) 243-2953

(914) 243-2953 Fax

February 2003 1100501 Page 0.01.3

Southern Region Varian Medical Systems Planning Department 2250 Newmarket Parkway, Suite 120 Marietta, GA 30067

(770) 955-1367

(770) 955-6936 Fax

International Support http://www.varian.com/support

Education Department

For information regarding Varian training courses, contact the location below:

Education Department Varian Medical Systems 596 Alder Drive Milpitas, CA 95035

(408) 321-9400

(408) 321-4445 Fax

PLANNING REGIONS

North American Regional Installation Coordination Offices

An Installation Project Manager inspects the on-site conditions and construction preparations. The Project Manager also supervises critical construction phases, such as base frame installation and final connections. All Planning Department correspondence will identify the Installation Project Manager for the project site. The regional office locations are listed below:

Northern Region Regional Installation Project Manager Varian Medical Systems Service 200 East Howard Street, Suite 202 Des Plaines, IL 60018

(847) 296-0660

(847) 296-8316 Fax

Southern Region Regional Installation Project Manager Varian Medical Systems Service 2250 Newmarket Parkway, Suite 120 Marietta, GA 30067

(770) 955-1775 (770)984-6249 Fax

North American Regional Sales Offices

The Varian Sales Manager is most familiar with the specific equipment order information. To verify equipment ordered, including specific options to be provided, contact either the Customer or the District Sales Manager. The regional office locations are listed below:

February 2003

Atlanta, Georgia Varian Medical Systems 2250 Newmarket Parkway, Suite 120 Marietta, GA 30067

(770) 955-1367

(770) 984-6249 Fax

Chicago, Illinois Varian Medical Systems 200 East Howard Street, Suite 202 Des Plaines, IL 60018

(847) 296-5533

(847) 296-0043 Fax

New Jersey Varian Medical Systems 100 Walnut Avenue Clark, NJ 07066

(732) 381-5300

(732) 381-1060 Fax

Southern California Varian Medical Systems 650 East Parkridge Suite 109 Corona, CA 92879

(909) 280-4401

(909) 280-4300 Fax

Terminology for Accelerator, Simulator and Remote Afterloader General Information

June 2003 1100503 Page 0.02.1

Acuity® - Varian trade name for its simulator. The simulator is used to assist with treatment planning for determining the method and position to use during actual treatment.

Arc Therapy - A form of radiation therapy in which the radiation beam is continuously directed toward the isocenter as the linear accelerator Gantry is rotated in an arc.

Attenuation - The reduction of intensity upon passage of radiation through a medium caused by absorption and scattering.

Backpointer Laser - A linear accelerator accessory, usually mounted to the Gantry, used to identify the central axis of the radiation beam.

Base Frame/Plate - Varian-supplied assembly that anchors the

Stand/Gantry and the Couch, to the building structure.

Beamstopper - Optional fixed or retractable attachment for the

Clinac designed to attenuate the primary beam. A Clinac equipped with a Beamstopper does not require primary beam shielding. Rooms for Clinacs equipped with a Beamstopper can be designed for leakage/scatter (Secondary) radiation shielding only. When the Gantry is rotated to certain positions, the Beamstopper may interfere with movements of the couch. The presence of a Beamstopper may preclude the addition of some accessory options. Consult with the Regional Varian District Sales Manager regarding accessory restrictions.

Blocks and Block Trays - Accessories used to shape the treatment field. Blocks are custom made for each patient and are supported by the Block Tray at the Clinac Collimator. 40 to 100 Block Trays may be in use daily.

Breakdown - The manner in which a Clinac is disassembled for shipment. Three-piece breakdown leaves the Stand and Gantry connected. A four-piece breakdown separates the Stand and Gantry, and is used to shorten the space required for passage into the treatment room. The four-piece breakdown involves extra cost.

CCTV - A closed-circuit television is used for observing patients from the control console. The system can be color or black-and-white and consists of one or two cameras and one or two monitors. Verify quantity of cameras required with regional regulatory agencies. The primary camera will normally include an auto-focus and low -light level lens with power zoom. It will be mounted on a bracket incorporating pan-tilt features. The control console must include remote controls for the zoom and pan-tilt.

Circuit Breaker - A device designed to open the circuit automatically at a predetermined over current without damage to itself or the protected device it serves.

Clinac® - Varian trade name for a range of Linear Accelerator models used in cancer treatment and stereotactic radiosurgery. Low Energy (600C, 4EX, 6EX and 600SR) models have different facility requirements from Dual Energy (2100C/D, 2300C/D, 21EX, 23EX) models. Re-built Clinacs (4R, 6XR and 18R) have similar characteristics to the in-production models.

Collimator - A movable, radiation-limiting device, located in the head of the Gantry, used to define the radiation field.

Computerized Tomography (CT) - Technique for making computer-generated images of a predetermined plane section of a patient's body by rotating an x-ray tube around a patient.

Cone - See Electron Applicator.

Control Equipment Casework - Casework designed to accommodate Varian control equipment and workstations.

The Control Equipment Casework is located outside the Clinac or VariSource, GammaMed room and usually located behind a wall within the Acuity room. The control equipment is used for setting mechanical and treatment parameters.

Couch - The assembly used to support the patient during treatment or simulation. It can move vertically, longitudinally and transversely to position the patient treatment field at Isocenter. The minimum travel radius must be free of obstructions. Its maximum travel radius defines the maximum distance from isocenter throughout its travel range that the Couch can operate. As the couch is seldom used in all orientations, the maximum travel radius can have obstructions without detriment, but it is recommended that the Customer and Varian's Planning Department be consulted.

Door Interlock - A switch that enables a fail-safe safety circuit linked to the Clinac , VariSource, GammaMed or Acuity when the door to the room is closed. The door must be closed before radiation treatment or simulation can proceed. If the door is opened during treatment or simulation, the beam is turned off.

Dynamic Wedge - An accessory used to generate a wedge-shaped isodose contour, analogous to physical wedges, by moving one of the Collimators during the course of an x-ray treatment.

Dynamic Compensation - A superset of the Dynamic Wedge where one or more mechanical axes move during the course of an x-ray treatment to conform the dose distribution to the treatment volume. This technique can affect the room barrier shielding design.

Electron Applicator - An accessory, often called a "cone" that is mounted to the Clinac or Acuity Collimator that defines the treatment field for electron therapy. These are required for the Dual Energy Clinacs and are optional with the Acuitys .

There are five, and one additional optional, units per set. They measure approximately 1'-0"x1'-0"x1'-4" (300x300x400) and weigh up to 20 lbs. (9kg) each. Their storage requires special design attention when it is incorporated into the treatment and Simulator room cabinetry.

June 2003 1100503 Page 0.02.2

Electron Radiation - A Primary Beam of radiation generated by the Clinac for treatment. Low energy Clinacs have no electron mode, while dual energy Clinacs have several selectable electron energies. Electron Radiation is less penetrating than Photon Radiation, and is used less often than Photon Radiation.

Electronic Cart Assembly - The VariSource Transportable

200t system comprises the VariSource Remote Afterloader (VRA) and Electronic Cart Assembly (ECA). The ECA houses the VariSource, GammaMed Control Console and Treatment Planning System plus peripherals and storage for accessories. The ECA and VRA form a single articulated vehicle facilitating transport and installation once at the designated site. This ECA is connected via Varian supplied cables to the Wall Box and the grounded duplex electrical power receptacle located in the control console area.

Emergency-Off Switch - A "mushroom" button used to disable the Clinac , VariSource, GammaMed or Acuity. The switch must have a manual reset feature. Emergency-Off switches are provided at equipment Stand, Couch, and Modulator Cabinet. Additional switches must be provided to disable the Clinac without entering the Primary Beam and in accordance with local regulations.

Experimental Access Conduit - The installation of an experimental access (physics) conduit between the interior of a Clinac or VariSource, GammaMed treatment room and an accessible point outside the treatment room, may be requested by the Customer. It is used periodically with a Water Phantom/Beam Scanner System in Clinac treatment rooms. The conduit should be oriented as perpendicular to the isocenter as possible.

Eyebolt - A bolt with a looped head used to suspend the

Couch during maintenance. Three are recommended for new construction and are located over the Isocenter.

Retrofitting eyebolts to existing concrete structures is not recommended.

Final Field Defining Aperture (FFDA) - An accessory that is fabricated to shape a patient's electron beam treatment field.

It installs into the Electron Applicator during patient set-up.

Fluoroscopy - Real-time imaging by means of a fluoroscope, which is a device used for viewing patients during simulations. Fluoroscopic capability is a standard feature of the Acuity.

Freight - Refers typically to the shipment of Varian equipment, beginning with the pick-up at the factory and ending freight-on-board (FOB) at the facility. See also Rigging.

GammaMed – See VariSource

Gantry - Rotating part of the Stand/Gantry assembly. The

Clinac Gantry contains the accelerator guide, bending magnet (Dual Energy Clinacs) and Collimator. The Acuity Gantry contains the x-ray tube.

In-Room Monitor - Display that describes the status of the equipment setup and patient parameters. The staff uses this monitor in the treatment room as they set up the patient. It is important to locate the monitor such that viewing the monitor during the Setup process shall not distract the therapist from the patient. Consult with the Customer regarding monitor location preference. The In-Room monitor should not be located in any x-ray primary beam.

Intercom - Two-way electronic communication device used to monitor the patient audibly in the treatment room from the control console during treatment. The intercom is important for dialog between the therapist setting the patient up and the radiation equipment operator, and to monitor the patient when the therapist is out of the treatment room. The intercom should have duplexing and be voice-activated or continuous-on in the room and push-to-talk at the control console. When the Acuity and its console are in two adjacent areas with no door between, an intercom may not be needed.

Isocenter - The point in three-dimensional space about which the Gantry, Collimator and Couch turntable rotate in common. This point is the central reference for all calibrations and critical shielding dimensions. It is a guide for positioning the Base Frame pit, Lasers, Couch, Clinac /Acuity and the patient during treatment procedures.

Junction Box - A conduit body that is used to access and terminate conductors or house an electrical device. For purposes of Clinac and Acuity requirements, the Varian-supplied cables are pulled and housed in conduits terminated at Pull Boxes, while the lighting control relays are housed in a junction box.

Laser Positioning Lights - Laser devices used to position the patient on the couch for treatment or simulation. Four lasers are used in the treatment room. Their light beams intersect at the isocenter. The side and overhead lasers throw both vertical and horizontal beam planes that create a crosshair.

The sagittal laser is located ahead of the Couch and at least seven feet above the floor and throws only a vertical beam plane. Rigid installation of the lasers is critical. A back pointer laser, which is mounted on the Gantry counterweight or beamstopper, may be ordered with the equipment. The back pointer laser, along with the wall-mounted lasers, creates an intersection of light defining the radiation exit axis.

Last Man Out - See Search/Evict.

Maze - A treatment room entrance hallway designed to reduce radiation levels, particularly neutrons, at the entrance door.

The length of and occupancy beyond the maze affects the amount of shielding required in and around the door.

Modulator Cabinet - Power control unit for all Dual Energy

Clinacs. The Modulator is located in the cabinet behind the machine. Cable length should be considered relative to the console.

June 2003 1100503 Page 0.02.3

Multileaf Collimator (MLC) - Collimator system designed to define the silhouette of a beam of radiation. This optional system, only available for the 600C, 2100C, 2100C/D and 2300C/D Clinacs, reduces the need for blocks and block trays. The effect of the MLC system on the architectural requirements is limited to an increase in the control console requirements.

Network - A system of interconnected computers. A computer network usually links two or more personal computers (Workstations) to a centralized storage device (File Server).

Networks provide users at different locations with the capability to share software, information and peripheral devices, such as printers. See VARiS.

Neutron Radiation - A particle form of Secondary Radiation produced by high (>= 10 MV) energy photons incident on high atomic number materials such as steel and lead.

Occupancy - The purpose or activity for which a space is used with regard to an occupant's length of stay while radioactivity is present. The values used for determining requirements in Varian documents are: 0% for no occupancy within a 60 foot (18,300) radius from the radiation source; 10% for exterior areas; 25% for service or circulation areas; 50% for treatment, exam and waiting areas; 100% for control, office or areas of unknown occupancies.

Pendant - Hand-held remote control unit attached to the Couch that is used to position and adjust the Couch, Gantry and Collimator for patient treatment. The Pendant also houses controls for room lights and Laser Positioning Lights.

Photon Radiation - A Primary Beam of low (< 10 MV) or high (>= 10 MV) energy penetrating x-ray radiation generated by the Clinac for treatment. Low energy Clinacs have a single x-ray energy of less than 10 MV, while dual energy Clinacs have one similar low energy, and one high energy x-ray energy of 10 MV or greater. The term "Photon Radiation" also refers to the x-ray leakage radiation and scatter radiation that is either emitted from the Clinac or scattered from the shielding barriers, respectively.

Physicist of Record - The physicist with the responsibility for assessing parameters and limits associated with the Clinac or VariSource, GammaMed. With regard to facility shielding, the Physicist of Record is responsible for designing the treatment room radiation shield barriers and confirming they meet applicable regulatory requirements. The facility design is based on regulatory requirements of the regulatory body tasked with oversight of Radiation Producing Devices in the Region, and recommendations of the National Council of Radiation Protection and Measurement (NCRP). Confirmation of the shielding adequacy is assessed with a radiation survey performed by a qualified physicist, which may or may not be the Physicist of Record. The Physicist of Record will correspond with the Region's Department of Health Services (or equivalent) regarding the design and results of the radiation survey.

PortalVision (PV) - Real-time imaging system for monitoring and verification of treatment field and shielding blocks in relation to anatomical landmarks. The effect of PortalVision on the architectural requirements is limited to an increase in the control console requirement.

Power Panel - An assembly of circuit protection and control devices.

Primary Beam Radiation - The emission or propagation of photons or electrons along the main axis or direction of the generating equipment (see Photon Radiation and Electron Radiation). Clinacs generate a 28-degree primary radiation beam cone from a source in the Gantry (measured one meter back from isocenter). Acuity generates a 39-degree primary radiation beam cone from a source in the Gantry (measured one meter back from isocenter). Shielding for the primary beam must consider the 360-degree rotation of the Gantry and should extend at least one-foot (300) beyond the beam cone.

Pull Box - A conduit body that is used only to access conductors. The distinction is made to simplify the NEC or other regulatory agency requirements for placement and construction of these structures. The Control Console , Base Frame, and Modulator boxes are Pull Boxes, as no termination of conductors is made in them.

Radiation monitor/detector - Device that senses radiation and issues a warning when the radiation level exceeds the preset standards. Some jurisdictions require them in accelerator rooms as a precautionary measure.

Radiosurgery - A method of treatment that uses a single, high dose of radiation to alter the tissue to cause necrosis or fibrosis. This procedure uses Gantry, and sometimes Couch, movement during the treatment to minimize exposure to surrounding tissue.

Radiotherapy - A method of treatment using multiple, small radiation doses to gradually shrink and kill malignant tumor cells.

Relay - Automatic electromagnetic or electromechanical device that responds to a small current by activating switches in an electric circuit. Lasers and room lights are connected through relays to the switches in the Pendant and on the Couch.

Rigging - Positioning of the Base Frame and the Clinac , VariSource, GammaMed or Acuity components into the treatment room. The Base Frame is rigged prior to the rest of the equipment. A rigging company is usually hired by the Customer to off-load these items from the truck and to move them through the facility into the treatment room. The Customer's architect and structural engineers must review the entire rig route for adequate clearances and structural support. The work can include temporary demolition and shoring. Final equipment positioning is part of the rigging contract. See also Freight, and Breakdown.

June 2003 1100503 Page 0.02.4

Safety and Monitoring Devices - Special equipment required to assure that the technical and service personnel are not exposed to radiation. These items are Emergency-Off Switch, Radiation Monitor/Detector, and Warning Light. (See definitions.) Other monitoring equipment is used to observe and position the patient during treatment. These items are CCTV, Intercom , Laser Positioning Lights , and View Window . (See definitions.)

Search/Evict - A procedure, usually involving some form of electro-mechanical interlock to the equipment, which provides added assurance that only the patient is in the room during treatment. (Also called "Last man out" procedure.)

Secondary Radiation - The emission or propagation of neutrons and/or photons as a result of bouncing or reflecting in various directions. Its sources are leakage from the equipment head and scatter from the room surfaces.

(see Electron Radiation, Neutron Radiation and Photon Radiation above)

Simulator - Radiotherapy equipment, such as the Varian

Acuity, that uses radiographic and fluoroscopic imaging to duplicate the beam geometry of medical linear accelerators as a means to localize the treatment field.

Stand - Fixed part of the Stand/Gantry assembly containing the

Klystron, power converters, cooling water heat exchanger, microwave generator and other elements of the linear accelerator and similar components of the Acuity.

Start Button - An override connected to the Emergency-Off circuit and to a separate, interim power source, which allows interim power to close the UVR circuit until Clinac power is available.

Stereotaxis (n), Stereotactic (adj) - The principle of locating a point in three dimensional space, within the brain, with a high degree of accuracy, by using an external reference coordinate system or plane.

T-switch - A device used to switch the In-Room Monitor presentation between the Control Console display (C-Series only) and the VARiS display.

Total Body Irradiation (TBI) - A technique during which a large-field x-ray or electron beam is used to treat the entire patient's body. Due to the increased field size, a distance of 10 to 20 feet (3 to 6 meters) is required from the isocenter to the wall on one side of treatment rooms designed to accommodate the procedure.

Under Voltage Release (UVR) - Safety feature that trips the breaker when an under-voltage condition occurs. Used in conjunction with Clinac and Acuity emergency off circuits to trip the main circuit breaker power to the equipment.

VARiS - An advanced information platform designed to unify the clinical and administrative aspects of radiation oncology. This Varian product consists primarily of software that will run on Customer or Varian-supplied computer hardware.

The effect of VARiS system on the architectural requirements is limited to an increase in the control console size requirement. The Clinac and Acuity Workstations can be linked by the Network Fileserver to form a local area Network. Editing Workstations are optional stations located away from the Clinacs and/or Acuity consoles.

See also Network.

VariSource - Varian’s high dose rate remote afterloader delivers high radiation doses to patients by way of a radioactive source wire that is extended through catheters into body cavities.

View Window - Patient monitoring opening in the wall between the Control Equipment Casework and the Acuity room spanned with leaded glass. Low energy accelerators occasionally have view windows but this is not recommended.

Warning Light - A light (usually red) that indicates "beam-on" condition. A light for "ready" mode may be required also.

Water Phantom/Beam Scanner System - A clear tank, part of a set of components, used to simulate a human body on the treatment couch to determine an accurate radiation output and dose distributions of a linear accelerator. The water phantom, which measures up to 2'-0" x 2'-0" x 2'-0" (600 x 600 x 600), is used by the therapists and physicists. It needs to be filled with water before use and the water needs to be siphoned off after use. Water supply, drain, and water-resistant storage space for the tank should be provided within the treatment room.

Regulatory Agencies

Contractor

Varian - Installation Coordination

Varian - Clinical Support

Architect/Engineer

Varian - District Sales Manager

Varian - Planning Department

Customer

A Typical Site Preparation Process

Varian - Customer Support

A B DC HGFE NMLKJI

Not For Constructionm e d i c a l s y s t e m s V A R A N

20.03 0.03

Typical Site Preparation Process Clinac / Acuity / VariSource/GammaMed VARiS / Eclipse

1102372

10 - General Notes

The Typical Site Preparation Process diagram is provided to assist the Customer in the early project planning stages. This diagram can be labeled or modified to reflect a project's specific schedule.

10.627

These items apply only to Clinac and Acuity projects.

10.628

The Customer is responsible for coordinating program requirements with the intended equipment users and the Architect. The Customer should review with the Architect the specific equipment and options ordered as well as any future considerations. All physics design, testing and acceptance coordination is the responsibility of the Customer.

10.629

The Varian District Sales Manager is the primary Customer contact during pre-sale activities.

10.630

The Varian Planning Department provides Customer site preparation support from pre-sale to the start of construction. Site specific drawings, site review, technical phone support and document review are services available to the Customer and the Customer's design representatives.

10.631

The Installation Coordinator becomes the Customer's primary contact from the start of construction to the start of the equipment installation. The Installation Coordinator's responsibilities include the coordination of equipment delivery and installation, technical phone support, shipping notice distribution, verification of pre-installation checklist items and scheduling of product training.

10.632

The Varian Customer Support representatives provide warranty and service support.

10.633

The Architect and Architectural Engineers provide design, documentation and construction administration services to the Customer. The Architect should be the Customer's primary representative for the distribution of Varian provided information during the entire design and construction phases. The Architect should send periodic construction document sets to the Planning Department for review prior to the construction bidding process.

10.634

The Building Contractor is the Customer's representative for construction services.

10.635

Submittals to the required Regulatory Agencies is the responsibility of the Customer. Varian does not check submitted documents for compliance with regional building codes or other regulatory requirements.

10.636

The Clinical Support Department provides on-site instruction (both basic and advanced) on Varian products. Customized capability offerings provide implementation and organizational assistance for new technology and system development.

10.659

70 - Radiation Shielding

Prior to source distribution, Varian is required to verify that Customers have a license to possess and use the source with the high dose rate remote afterloader. Prior to recieving a source, Customers shall provide Varian with a current copy of their license indicating the maximum activity allowed for use.

70.574

Typical Site Preparation Process Clinac/Acuity/VariSource/GammaMed/VARiS/Eclipse

0.03.1 0.03.1page:doc. #:revision:

© Varian Medical Systems 2001

All rights reserved.

Not For Construction

Refer to the Varian Components Chart at the end of this section.

[000]

:page 1102372201Feb03 planning dept.

A Typical Department Plan

Not For Constructionm e d i c a l s y s t e m s V A R A N

30.04 0.04

Typical Department Plan Clinac / Acuity / VariSource/GammaMed / VARiS / Eclipse

862455

The VariSource Transportable 200t system comprises the VariSource Remote Afterloader (VRA) and Electronic Cart Assembly (ECA). The ECA houses the VariSource Treatment Control Console And Treatment Planning System plus peripherals and storage for accessories. The ECA and the VRA form a single articulated vehicle facilitating transport and installation once at the designated site. This ECA is connected via Varian supplied cables to the Varian Wall Box and the grounded duplex electrical power receptacle located in the control console area.

The GammaMed Transportable system comprises the GammaMedplus Remote Afterloader (GRA) and the GammaMedtrolley (Trolley). The trolley houses the GammaMed Control Console and Treatment Planning system plus peripherals and storage for accessories.

The Trolley and GRA form a unified vehicle facilitating transport and installation once at the designated site. This Trolley is connected via Varian supplied cables to the Junction Box and the grounded duplex electrical power receptacle in the control console area.

10.654

67 - Communications

A dedicated analog modem phone line is required at the location of the VARiS System Administrator Workstation.

67.178

80 - Room Labels / Descriptions

VARiS Workstations may be located throughout the department and are linked via a network.

80.298

A secondary entrance is usually provided for use by staff and for ambulance patient access.

80.299

Treatment planning…