MOBETRON 1000 Facilities Requirement and Planning Guide

Drawing Number: 20623-1 Rev. F 01/07

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DOCUMENT CHANGE HISTORY

REV.
A B C D E

CHANGE DESCRIPTION Original Release Not Released Misc. Updates Extensive Updates Inserted New Section 5, Incorporated IORT1000J Converted to Framemaker Format Corrected Storage Power Added Crate Drawings

DATE 07/99

PAGES

02/00 5/24/01 10/23/03

Throughout Throughout 5,25, Figs 1, 2, 3, 4, 5, 6, 8, 9, 10 All 13, 27 - 32

1/03/07

This document contains proprietary information which shall not be reproduced, transferred to other documents, disclosed to others, used to manufacture, or for any other purpose in whole or in part without prior written permission of Intraop Medical Corporation.

For further information, please contact: INTRAOP Medical Corporation 570 Del Rey Avenue Sunnyvale, CA 94085 www.intraopmedical.com Authorized Representatives and Distributors: Tel. (408) 636-1020 Fax (408) 636-0022

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Drawing Number: 20623-1 Rev. F 01/07

Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) Physical dimensions of the Mobetron components and support cabinets b) Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c) System Cooling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . d) Floor Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e) Required free space during treatment . . . . . . . . . . . . . . . . . . . . . . . . f) Storage Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . g) The Modulator Cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h) The Operators Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2) Radiation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1) Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2) Calculations and Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3) Added Radiation Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . 4) Operating Room Evacuation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3) Facility Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) Operating Room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b) Storage Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c) Service Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . d) Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4) Site preparation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) Corridors and Doorways . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b) Floors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c) Operating Rooms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5) Facilities Staff and Equipment Requirements . . . . . . . . . . . . . . . . . . . . . . . . 6) Logistics: (A typical treatment sequence, step by step) . . . . . . . . . . . . . . . . 7) Treatment Unit Weight Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8) External Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9) QA Dose Chamber Cap Modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10) How the Mobetron is Packaged . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11) Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figures: Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. Fig. 1 Treatment Unit Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Treatment Unit Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Treatment Unit Top View, Gantry Rotation and Head Tilt Extremes 4 Treatment Unit Top View, Storage Position . . . . . . . . . . . . . . . . . 5 Modulator Cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Operators Control Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Treatment Unit during Transport . . . . . . . . . . . . . . . . . . . . . . . . 8 OR Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 System Components and Interconnections . . . . . . . . . . . . . . . . . 10 Operating Room Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Treatment Unit Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 QA System on Treatment Unit . . . . . . . . . . . . . . . . . . . . . . . . 13 Treatment Unit Weight Distribution . . . . . . . . . . . . . . . . . . . . . 14 External Connections for Interlocks and Warning Lights . . . . . . . 15 Dose Chamber Cap Modification . . . . . . . . . . . . . . . . . . . . . . . 16 Mobetron Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 7 8 9 10 11 14 16 17 18 22 22 23 24 26 28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5 5 5 5 5 6 9 10 11 12 12 12 12 12 13 13 13 14 14 15 15 15 15 19 21 23 24 25 27 31

Drawing Number: 20623-1 Rev. F 01/07

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Preface
The Mobetron Facilities Requirements and Planning Guide provides information for hospitals who are planning the installation of a Mobetron for use in an Intraoperative Radiation Therapy (IORT) program. The information is most useful for those individuals who are directly responsible for project planning, performing facilities modifications, installation coordination and commissioning of the Mobetron. Persons who generally need this information would include, but not be limited to; IORT Program Director Radiation Oncology Physicist Radiation Oncology Chief Therapist Radiation Safety Office Operating Room Head Nurse Facilities Engineering Bio-Med Services (electronic systems maintenance) Purchasing Planning for a Mobetron installation is a coordinated effort between Intraop Medical (or its distributor), and the various departments within the hospital. If at all possible, a hospital Project Manager should be assigned to oversee and coordinate these activities. This can be one person early on, then transition to different individuals as the planning process continues. Preliminary planning should begin before the purchase is made, and detailed facilities planning three to four months before scheduled delivery. A period of one to two months should be anticipated to complete all of the installation, acceptance testing, beam commissioning and room commissioning that will be required. Most hospitals have used four to six weeks of staff training before their first Mobetron IORT treatment. Visits to and communication with other Mobetron facilities can be helpful and is recommended. Intraop Medical and your local distributor are pleased that you are considering or have decided upon the Mobetron to fill your IORT program needs. Please do not hesitate to contact us with your questions concerning facilities planning or any other item that will make the installation of your Mobetron an enjoyable experience. One of our installation coordination representatives will visit you approximately six weeks prior to shipment of the Mobetron to finalize the delivery details.

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Drawing Number: 20623-1 Rev. F 01/07

1) Overview
The MOBETRON System is a portable linear accelerator for electron therapy. Easily transportable, the MOBETRON can be used in existing Operating Rooms, (O.R.)providing a maximum in flexibility and utilization. The room to be used for initial trials should be chosen in advance of delivery, and should provide easy access for acceptance procedures. System setup and Acceptance Tests require beam production for extended periods. These initial trials must be conducted in a shielded or isolated area. Operating Rooms should be analyzed to determine suitability for MOBETRON use. Complete system specifications are provided in the accompanying documents. A summary of features and parameters that will be needed for planning a Mobetron capable facility follow.

a) Physical dimensions of the Mobetron components and support cabinets:

Treatment Unit, in storage, Standard and (Motorized) configuration 99 (102) X 43 X 78, [251 (260) X 109 X 198 cm] (FIG. 4) Modulator Cabinet size and shape (FIG. 5) Control Console size and shape (FIG. 6) 28 X 36 X 77 [71 X 91 X 195 cm]

24 X 25 X 49 [61 X 63 X 125 cm]

Interconnection Details: (FIG. 9) Interconnection Layout (Also see Dwg. # M205321) Support Equipment Cart and Sterile Equipment Cart Supplied by User

b) Power Requirements (Select Voltage Configuration at time of order

Voltage Input: 200 / 208 / 240 / 380 / 400 / 415 / 480 / VAC +/- 5%, 50 / 60 Hz 3 phase delta, 4 wire (3 phase + safety ground) 6 kVA Service 15 Amps maximum per phase at 200 VAC (lower current at higher voltages) 3.5 kVA constant load, 4.2 kVA during beam production (2-4 min. / patient) Storage Power: 100 - 230 VAC

c) System Cooling
Heat Exchange to Air, 3.5 kW constant, 4.2 kw peak (2-4 min. / patient)

d) Floor Loading See (Fig. 13)

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 1 Treatment Unit Side View, Standard Transport

e) Required free space during treatment:

The MOBETRON has the ranges of motion as shown in figures 1, 2 and 3. During the application of Electron Beam Therapy, the MOBETRON treatment head may be positioned to the extremes shown by the outlines. Note: If the O.R. ceilings are lower than the 115 (293 cm) shown, it is possible to restrict the vertical travel of the Treatment Head to avoid collision. The minimum practical ceiling height for full Mobetron use in an OR is 285 cm.

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Drawing Number: 20623-1 Rev. F 01/07

Fig 2 Treatment Unit Front View In order to provide the full rotational range for clinical treatment, the Mobetron center line should not be located less than 63 (160 cm) from an O.R. wall. However, radiation protection requirements could increase this distance to 350 cm.

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 3 Treatment Unit Top View, Gantry Rotation and Head Tilt Extremes Position the Mobetron so as to avoid collision with OR equipment. The MOBETRON and the Modulator Cabinet will occupy a larger area in the OR than many other types of moveable equipment. Finding the space for the unit is not enough planning to make the installation a success. The location must be decided with due regard to overhead clearances, patient positioning, surgery workflow and OR traffic patterns. The Modulator Cabinet should be placed such that the cables to the Treatment Unit and the power outlet do not present a hazard or inconvenience. In some cases, the Modulator Cabinet can be in an adjacent room. These locations must be determined with the cooperation of the Operating Room personnel.

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Drawing Number: 20623-1 Rev. F 01/07

Motorized Version

Manual Version Fig. 4 Treatment Unit Top View, Storage Position

f) Storage Area:
In storage the Mobetron, the Modulator Cabinet, the Console and a support cart will occupy approximately 4.5 square meters (48 square feet). The Mobetron requires a standard wall power outlet in the storage location to continuously operate vacuum pumps. Note that while storage cabinets for Applicators and Accessories may be located in other hospital locations, the cart holding the cables and other operational items should be either near the Mobetron or in the control of the Mobetron Team.

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 5 Modulator Cabinet

The Modulator Cabinet:

The Modulator Cabinet contains the electronic sub-systems which power and control the MOBETRON. The Modulator Cabinet can be positioned up to 25 feet, (7.6 meters)* from the Treatment Unit. Electrical power for the Mobetron is connected by power cable from the Modulator Cabinet to the three phase wall outlet. *Other cable lengths may be specified when the MOBETRON is ordered. Add five feet (Approx. 1.5 meters) to the length ordered to include the distance from the floor to the cabinet connections.

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Drawing Number: 20623-1 Rev. F 01/07

Fig. 6 Operators Control Console. Side Dimension includes brake pedal

The Operators Console:

The Operators Console is connected to the Modulator Cabinet by an interconnect cable. Used to set the parameters for each treatment, the Operators Control Console is easily positioned for use. The maximum possible distance to the Modulator Cabinet is 45 feet (13.7 meters).* The Operators Console can be moved into position for use at the time of the treatment, but must remain connected to the Modulator Cabinet while stowed out of the way during surgery. The depth dimension shown here includes wheel lock tabs fully forward. *Other cable lengths may be specified when the MOBETRON is ordered. Add five feet (Approx. 1.5 meters) to the length ordered to include the distance from the floor to the cabinet connections.

Drawing Number: 20623-1 Rev. F 01/07

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2) Radiation Safety
1) Planning
Safe use of the MOBETRON requires careful radiation safety planning. Each location where there will be beam produced must be designated, surveyed and rated for total dose delivered over a defined length of time.

2) Calculations and Surveys

Each location where the MOBETRON will produce beam needs to be surveyed to determine stray radiation rates at critical locations adjacent to, above and below the Mobetron. Predictions of the stray radiation levels to be measured can make this process easier. However, due to the complex nature and large variations in building design, construction materials and techniques, accurate calculated stray radiation predictions for adjacent areas are at best approximations. Intraop Document Number IORT4001, provides information useful in these calculations. Contact the distributor for this document. Using the information generated in the calculations and surveys, occupancy factors for adjoining rooms and corridors and on the floors above and below for each room and location proposed for MOBETRON operation can be determined by the Radiation Safety Office. This information will be used to determine a Level of Use plan for use that will ensure the safety of the occupants of areas adjoining the MOBETRON rooms by limiting the beam to be produced in that location over a given number of days. Level of Use should be determined such that adherence to the Level of Use plan for each area where the MOBETRON will be used will keep total periodic accumulated dose to occupants of adjacent areas below legal or recommended levels. Examples of Level of Use plans at existing MOBETRON facilities based upon direct measurements and occupancy factors are available upon request.

3) Added Radiation Safety Precautions:

In situations where restricting the total beam produced by a MOBETRON does not render surrounding areas safe, other mitigation measures, such as controlling access during treatment, can be implemented. Inside the Operating Room, portable shields may be used to create areas of lower stray radiation as needed. Portable shields can also be positioned to reduce the stray radiation level outside a wall.

4) Operating Room Evacuation:

During the approximately two minutes that treatment is being applied, operating room staff will vacate the Operating Room or retreat to an area protected by portable shields within the O.R. Remote monitoring of anethstesia readouts by TV or other means to allow complete room evacuation is usually preferred.

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Drawing Number: 20623-1 Rev. F 01/07

3) Facility Requirements:
In this section, a method of analysis for proposed MOBETRON use areas will be outlined. Several rooms should be chosen and rated prior to delivery and testing of the system. The first choice of Operating Rooms is always the largest. Department of Surgery OR allocation and scheduling practices will influence OR choices.

a) Operating Room
1) Operating Room Blueprints and Survey Layout the space occupied in the Operating Room by the MOBETRON during active use and in the standby position. The Operating Table will be moved to the MOBETRON to apply treatment. During surgery, there will be carts, tables, equipment racks, IV poles and other portable equipment in close proximity to and associated with the Operating Table. Allow space for moving these items when setting up the radiation treatment. See (FIG. 10) Typical OR Layout 2) Cable Routing and Power point locations: Potential interference with OR activities must be considered along with MOBETRON motions when choosing the position of the MOBETRON in the OR. Ideal cable routes will be along the base of the Operating Room walls, without crossing any doorways. Cable distances given herein include allowances for typical vertical runs to the connections. For further information, see Section 4. 3) Standard Cable Lengths: The Modulator Cabinet must be within 25 feet (7.6 m) of the Treatment Module. The Control Console operating location must be within 45 feet (13.7 m) of the Modulator Cabinet. The Control Console may be moved into an out-of-the-way location closer to the Modulator Cabinet to protect the cable while waiting for use. A three phase AC, 4 wire, electrical power outlet must be available within 45 feet (13.7 m) of the Modulator Cabinet location. 4) Other System Positioning Considerations When considering equipment locations, be aware of any cabinets, power panels or other permanent fixtures with which the system could interfere. 5) Flammable Anesthetics The MOBETRON is not to be used in a flammable atmosphere.

b) Storage Area
1) Storage Space Required An area convenient to the Operating Rooms, approximately 43 square feet (4 square meters), to store the three units of the MOBETRON System plus two Equipment carts will be needed. The Mobetron requires AC power from a conventional wall outlet (110 - 240 VAC, 50 / 60 Hz) to maintain accelerator vacuum during storage. (The appropriate voltage must be selected inside the system before connection is made.)

c) Service Area
If facility space permits, a Service Area away from the OR will provide a space in which tests and repairs may be performed without disrupting the OR schedule.

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The Service Area will need to have: 1) Adequate space for disassembly of Mobetron subsystems. 2) Three phase power outlet matching the OR power outlets. 3) Ventilation to dissipate 4.2 kw. 4) Optional but useful, a Radiation Safety survey and Level of Use plan to allow beam production.

d) Transport
1) Moving the Treatment Unit The Mobetron can be easily moved through hallways and doors by two people. One will serve as a guide, advising the person moving the system as to clearances, clearing obstructions and opening doors. Bridge plates will be required to roll the MOBETRON into and out of elevators and over floor mounted access panels. Note: The MOBETRON should never be moved along any inclines by hand.

Fig. 7 Treatment Unit during Transport 2) Moving the other MOBETRON components The Modulator and Control Console can each be moved by one person. Cabinets and Carts carrying cables and instruments used during daily activities are normally handled by one person.

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Drawing Number: 20623-1 Rev. F 01/07

4) Site preparation requirements

a) Corridors and Doorways:
The distance from a doorway to an opposite wall will dictate the size of the opening needed to allow the MOBETRON to pass. When there is eight feet (254 cm) of clearance in front of the doorway, a width of at least 48 inches (122 cm) will be needed to allow the MOBETRON to pass. If the clearance is nine feet (274 cm), there will be room enough to turn the MOBETRON for a direct approach to a 44-inch (112 cm) doorway. Inside an OR, similar considerations in doorway approaches apply. Check each proposed room for immovable obstructions on the walls, floor and ceiling. Some of these obstructions will not appear on the floor plans.

b) Floors:
Floor surfaces should not be carpeted. If carpets are unavoidable, metal or plywood plates must be used to protect the carpeting from damage. Check for metal plates covering access openings, and for any other areas where the floor may not have its full strength. Hidden cable trays, floor located power outlets (sometimes found in patient waiting areas) and other spots where the floor surface may not be fully supported for any reason must be identified. Plans must be in place to avoid damaging either the facility or the MOBETRON before the system is transported over these areas.

c) Operating Rooms:
All rooms considered for MOBETRON treatments must have a minimum ceiling height of 115 inches (2.93 m). Other room dimensions must take into account the Mobetron footprint and range of motion. See (FIG. 1 - 3) Motions Other considerations will include, but are not limited to: See (FIG. 8) OR Layout Operating Table positioning (during surgery and during Mobetron treatment). Anethstesia equipment clearance and transport. The location of substerile waiting areas for scrubbed staff and the location of immovable obstructions. A three-phase electrical power outlet must be located within 45 feet (13.7 m) of the proposed locations of the Modulator cabinet. The Modulator to Treatment cable allows a range of about 25 feet (7.6 m) from the Modulator for positioning flexibility. The Control Console cable allows a range of about 45 feet (13.7 m) from the Modulator Cabinet for positioning flexibility. The Control Console location for treatment use must be in a location shielded from stray electron radiation. If any cables must pass through doorways, special care must be taken to protect the cables from damage. This can take the form of removable doorstops, cable passage openings, or other schemes. In many areas, openings into Operating Rooms are strictly prohibited. Check local regulations concerning any such opening. The cable connectors on interconnect cables require a four-inch diameter cable pass opening. The cable connector diameter for the main interconnect (the largest cable) is two and one half inches.

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Fig. 8 OR Layout When planning a room for MOBETRON use, consider occupancy factors for surrounding areas as carefully as cable routing and setup positions. The system is calibrated with a single cable length. Multiple room layouts or plans involving cables permanently installed must use this length as a standard.

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Drawing Number: 20623-1 Rev. F 01/07

MAIN POWER

MODULATOR

EXT. INDICATORS

EXT. INTLK INTERCONNECT CABLES TREATMENT UNIT

EXT. INTLK

CONTROL CONSOLE

Fig. 9 System Components and Interconnections External interlocks such as door switches or stray radiation monitor contacts may be connected to the Mobetron at either the Modulator Cabinet or the Operators Control Console. Beam On and Ready lamp controls can be connected at the Treatment Unit interconnect panel. Reference (Fig 14), External Connections.

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 10 Operating Room Layout Treatment Module: Allow space for full range of MOBETRON motion. Also allow space for the patient IV poles, anethstesia hoses, lead wires and other ancillary equipment that will be moved along with the patient and OR Table to the MOBETRON at the time of treatment. Treatment Module Re-Positioning: Some ORs will not be usable with the Treatment Module standing in the treatment position awaiting use. Some ORs will be better utilized by having the system standing along a wall, ready to be pivoted into the treatment position at the time of use, then pivoted back for the completion of surgery. This solution requires that the Mobetron be stored in the OR, as the pivot wheels are not aligned for transport. Another RePositioning solution is to bring the Treatment Module forward from an out of the way staged position into a treatment position. This can be done with the Treatment Module in its standard or Motorized configuration. Modulator Cabinet: Position this unit such that the cables to the Treatment Unit and the Power Connection do not introduce a tripping hazard. Operators Control Console: During beam operation the Control Console must be in a radiation shielded area. Possible locations are the scrub room (or other sub-sterile room) or a hallway. While waiting for treatment setup to begin it can be moved inside the OR, and placed such that the cable presents no tripping hazard.

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Drawing Number: 20623-1 Rev. F 01/07

5) Facilities Staff and Equipment Requirements:

During the approximately two week Installation process, the facility should be ready to assist the installation engineer with: Traffic management as needed for the delivery of the equipment Power connections and safety interlock connections in the Test area Power and interlock connections in the Treatment area Radiation Protection survey in the Test area Radiation Protection survey in the Treatment area Radiation equipment calibration instruments for preliminary testing before acceptance testing. (Beam Scanner, Dose meter) Radiation equipment calibration instruments and physics staff for the approximately five days of acceptance testing, and through the system commissioning process Modified QA Dose Chamber Cap (See section 8) After installation and before the first treatment, an In-Service training day will be held in the OR for the staff of both the Radiation Oncology and Surgical Oncology teams. When the system is commissioned and ready for use, the facility will assign the following tasks to appropriate personnel: Transport, setup and QA tests before the OR is set up for surgery OR liaison to arrange the notification of Radiation Oncology personnel in time for their timely arrival, and for other notifications as needed Accounting for all items used by the Radiation Team Positioning of the Treatment Applicator Operation of the system, Alignment and Docking Calculation of the delivered amount of radiation Teardown and transport to storage after the case is completed For times when maintenance or repairs are required, the facility will assign the following tasks to appropriate personnel: Arrange access to the system appropriate for the work to be done, usually in an OR or in a test area Accompany the service engineer during all service work for safety reasons Provide access to tools and equipment that the service engineer may not carry All persons working with the Mobetron should be trained in Radiation Oncology procedures and radiation safety measures. Radiation Oncology personnel should also be trained in OR procedures.

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Drawing Number: 20623-1 Rev. F 01/07

6) Logistics: (A typical treatment sequence, step by step)

a) Before surgery is begun, the Mobetron is moved into the OR.
See (Fig. 11), Treatment Unit Transport Moving the Mobetron into the Operating Room, assembling the system for use, warm up and QA testing can be done in about sixty to ninety minutes. Moving the Mobetron into the Operating Room the night before a morning treatment will reduce the time required that morning by thirty to forty five minutes. The Mobetron may completely occupy the hallways while being moved. Planning for the surgical day must take this into account.

b) Assembly, warm up and QA testing are performed.

See (Fig. 12), QA SYSTEM on Treatment Unit The shortest setup times include abbreviated calibration checks. The Clinical Physicist in charge of the Mobetron may choose to not require that seldom used energies be checked each treatment day.

c) After the warm up and QA tests are done, the Control Console can be moved into an out-of-the-way location.
The Control Console cable must remain connected until after the treatment. Be sure that this cable will be out of the way.

d) After the treatment is finished, the Mobetron can be returned to the transport configuration and shut down.
Cables can be removed and stored, and if the room setup permits, large components can be moved aside. Moving the Mobetron out of the Operating Room before the surgery is completed is not always practical.

e) When the surgery is completed, the Mobetron can be moved to the storage area or to another Operating Room.
Operating Room scheduling plays an important role. A second treatment may be administered in the same Operating Room by moving a patient to the Mobetron from another Operating Room, or by scheduling two or more short procedures for the same day, resulting in a tremendous time saving.

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 11 Treatment Unit Transport

Fig. 12 QA System on Treatment Unit

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7) Treatment Unit Weight Distribution

In use: The weight on each wheel or pad is influenced by the Gantry Rotation and Treatment Head Tilt positions: The maximum weight at each of the pads and wheels is 1050 lbs. In storage: The weight on each rear pad is 945 lbs. The weight on each front wheel is 490 lbs. The Wheel and Pad dimensions are: Front Wheels: 6 in. (15 cm) Dia. Rear Pads: 11 in. (28 cm) Length 2 in. (5 cm) Width 3.5 in. (9 cm) Width

34"

REAR PADS

54"

FRONT WHEELS

39"

Fig. 13 Treatment Unit Weight Distribution

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8)

External Connections

External Connection points are provided to allow external warning devices and interlocks to be used with the MOBETRON. The three plugs required to make connections to the MOBETRON are supplied with the equipment. Design, fabrication and installation of the devices is the responsibility of the user. Warning Light or Audible Alarm controls can be driven by the User Warning System connection located on the Treatment Unit connector panel. The relay shown closes contact when the MOBETRON is ready for Beam production. An interlock system, such as a door switch, stray radiation monitor or patient monitor can be connected to either or both of the External Interlock connectors, located on the connector panels of the Operators Console and the Modulator Cabinet. Breaking the connection will stop or prevent Beam production.

MOBETRON Treatment Unit Connection Panel USER MAINS POWER USER WARNING SYSTEM 2A, 250V MAX

A B C D G
ITT Cannon OAB106E20-15S-B

Power Cordage #16 awg minimum

MOBETRON Operators Console Connection Panel

Shielded 2 wire signal cable

A B C
ITT Cannon CA3106E24-28S-B

+24 VDC External Interlock #1

MOBETRON Modulator Connection Panel

Shielded 2 wire signal cable ITT Cannon CA3106E18-8P-B

A B G

+24 VDC External Interlock #2

Fig. 14 External Connections for Interlocks and Warning Lights

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Drawing Number: 20623-1 Rev. F 01/07

9) QA Dose Chamber Cap Modification

The daily QA system supplied with the MOBETRON employs a plastic phantom attached to a rigidly mounted applicator. (See Fig. 12) A selection of phantom inserts included with the system is used to position a dose chamber at depths appropriate to the energies produced. The inserts are drilled to accept a Farmer type dose chamber in a specially modified protective cap. The plastic protective cap, supplied with most Farmer chambers, is optimized for use as buildup for 60Co. To accommodate the shallow depths of the lowest MOBETRON energy and to fit the QA system inserts, the standard cap must be modified as per the drawing on the next page, B5660-1. The user is responsible for providing the Farmer chamber to be used with the QA system and for the modification of its cap. This item is required for Acceptance Testing.

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 15 Modify one dosimeter chamber cap using this drawing for reference. To be used with the QA System supplied with the equipment. (Farmer type Cobalt Buildup Cap shown.)

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Drawing Number: 20623-1 Rev. F 01/07

10) How the Mobetron is Packaged

The Mobetron arrives packed in several crates. Two are large, containing the Treatment Unit and the Modulator. These must be handled by a Forklift, or by use of a Crane and carefully positioned straps. A heavy equipment moving team will be required for handling these crates, and for removing the items therein. Other crates, containing various accessories and auxiliary components, are of a more easily handled size. These may be moved using a pallet jack or other standard loading dock tools. The following figures illustrate the packaging used.

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 16a Treatment Unit and Console

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Drawing Number: 20623-1 Rev. F 01/07

Fig. 16b Modulator Cabinet

Drawing Number: 20623-1 Rev. F 01/07

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Fig. 16c Accessories and auxiliary components

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Drawing Number: 20623-1 Rev. F 01/07

11) Summary
With adequate planning, the Mobetron can be used in a wide variety of Operating Rooms. Radiation Safety plays a key role in room planning. The Hospital will need to arrange that certain floor spaces and areas be reserved for Mobetron storage and service. Logistics and safety planning will be key factors in the success of a Mobetron site. For further information concerning site planning, user training programs or other questions regarding the MOBETRON, please contact your local distributor or Intraop Medical Corporation.

Drawing Number: 20623-1 Rev. F 01/07

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Drawing Number: 20623-1 Rev. F 01/07