REF # DOC #80XXX-00. STANDARD IMAGING, INC Deming Way Middleton, WI TEL TEL FAX

Transcription

1 REF STANDARD IMAGING, INC Deming Way Middleton, WI TEL TEL FAX Aug / Standard Imaging, Inc. DOC #80XXX-00 #

2 General Precautions WARNING: Follow manufacturer s recommended safety procedures for radioactive sources. Warnings and Cautions alert users to dangerous conditions that can occur if instructions in the manual are not obeyed. Warnings are conditions that can cause injury to the operator, while Cautions can cause damage to the equipment. CAUTION: Do not drop or mishandle the phantom. CAUTION: Refer all servicing to qualified individuals. CAUTION: Proper use of this device depends on careful reading of all instructions and labels. i

3 Table of Contents PAGE i General Precautions 1 Overview 2 General Operation 6 Maintenance 6 Parts 6 Features and Specifications 9 Service Policy 9 Customer Responsibility 10 Warranty 3120 Deming Way MIDDLETON, WI USA Overview The MIMI (Multiple Imaging Modality Isocentricity) Phantom is designed for daily or weekly quality assurance of the geometric accuracy of the isocenter described by several systems included on many modern linear accelerators: the positioning lasers, the kv imaging system, the MV treatment beam and in the case of the Varian FramelessArray, the optical guidance system. The MIMI phantom can also be utilized to test the shifts prescribed by the treatment console automate registration tool. The MIMI phantom is constructed of acetal copolymer with 5 bone equivalent black PVC rods which traverse the entire phantom at differing angles and one solid aluminum oxide 6.4mm diameter ball embedded at the center of the phantom. There are also 6-1mm diameter stainless steel ball bearings embedded into the surface of the phantom on 5 of the six faces which aid in alignment. Laser alignment lines are included for easy positioning along with L (left), R (right), A (anterior), P (posterior), F (foot), and H (head) indicator letters machined into the faces of phantom in correctly oriented locations to ensure consistent phantom orientation and interpretation both when placing on the couch and when viewing digital radiographs. For Varian FramelessArray systems appropriate mounting holes are located on the top of the phantom for placement and securing of the FramelessArray localizer which features the four infrared reflecting markers used for optical guidance. 1

4 General Operation Pre-test preparation 1. The MIMI phantom is placed on the CT couch. Align the phantom utilizing the positioning lasers on the CT machine and the laser alignment markings on the phantom. An axial CT scan of the phantom is acquired. High quality reference images are essential and should be saved for repeated use. It is recommended that the reference images be updated periodically to check for changes in the isocenter described by the CT scanner and treatment planning system (TPS) For Varian Systems with the FramelessArray system: Attach the FramelessArray localizer to the MIMI phantom before performing the reference image scan. 2. The reference images are imported into the TPS and a simple plan is generated where the bone-equivalent rods and the aluminum oxide ball are contoured and the center of the phantom is aligned to the isocenter described by the TPS. Digitally reconstructed radiographs (DRR) are created for the anterior/posterior (A/P) and right lateral (R. Lat) projections of the phantom. kv imaging and CBCT setup fields are setup in the TPS or the record and verify system. For Varian Systems with the FramelessArray system: The plan is transferred to the optical guidance control computer and the fiducials are registered. 2

5 General Operation continued Procedure for daily or weekly QA 1. Laser Alignment - The MIMI phantom is placed on the couch and aligned to the room lasers. a. Varian Frameless Array - The phantom is placed on the couch with the localizer attached. Utilizing the optical guidance control computer the phantom is aligned to isocenter. A check of the phantom position can then be compared to the in-room lasers to verify that the congruence of the optical guidance system isocenter with that of the laser positioning system. 2. MV Alignment - A/P and R. Lat images of the phantom are then obtained with the MV electronic portal imaging device (EPID). Visual inspection of the images can reveal angular misalignment of the phantom. The bone equivalent rods are positioned so that the 2D projection image of a correctly aligned phantom will show the rods intersecting at 45º angles. If this visualization is not correct an inspection of the phantom placement should be performed and corrected if necessary before proceeding. 3

6 General Operation continued Utilizing the treatment console registration software perform a 2D/2D match registration of the acquired images with the DRR images from the TPS. Verify that the shifts required are within tolerances set by your facility. This step verifies that the laser positioning system (and the FramelessArray system) isocenter coincides with the treatment beam isocenter. 3. kv system Alignment a. 2D - Acquire A/P and R. Lat images with the kv imaging system. Utilizing the treatment console registration software perform a 2D/2D match registration of the acquired images with the DRR images from the TPS. Verify that the shifts required are within tolerances set by your facility. b. 3D Acquire a full CBCT image set of the phantom with the kv imaging system. Utilizing the treatment console registration software perform a 3D/3D match of the acquired images with the original CT set from the TPS. Verify that the shifts required are within tolerances set by your facility. This step verifies that the kv imaging systems isocenter coincides with the treatment beam isocenter and through previous tests the isocenter described by the laser positioning system (and the FramelessArray system) 4

7 General Operation continued Procedure for testing prescribed couch shifts There are six 1mm diameter stainless steel ball bearings embedded into the surface of the phantom on 5 of the six faces. One of the ball bearings is offset with corresponding alignment marks on each face. 1. Setup the phantom with either the A/P and/or Lateral face(s) of the phantom aligned with the offset ball bearing. 2. Acquire either MV and kv A/P and R. Lateral images and utilizing the treatment console registration software perform a 2D/2D match of each set of images with the DRR images created by the TPS. Verify that the shifts prescribed by the registration software match the shifts that were purposely made on the phantom. 3. Acquire a CBCT image set and utilizing the treatment console registration software perform a 3D/3D match. Verify that the shifts prescribed by the registration software match the shifts that were purposely made on the phantom. 4. If your system features an auto-adjusting couch, have the system make the corrections to place the phantom in the correct isocentric position. Check to make sure the phantom is now aligned to isocenter either by visual inspection or by obtaining new alignment images and performing either a 2D/2D or 3D/3D match. This will test the system's ability to correctly apply shifts. 5

8 Maintenance Exterior cleaning of the device can be done with a soft brush and a cloth. Gently brush all surfaces to remove dirt and dust. Remove any remaining dirt with a cloth slightly dampened with a solution of mild detergent and water or a liquid disinfecting agent. Calibration is not required. There are no serviceable parts on the MIMI Phantom. If assistance is desired in the proper disposal of this product (including accessories and components), after its useful life, please return to Standard Imaging. Parts REF Description MIMI (Multiple Imaging Modality Isocentricity) Phantom Features and Specifications Phantom Dimensions Height cm (5.52 in.) Width cm (5.52 in.) Length cm (5.52 in.) Weight 6.1 lbs, 2.8 kg Materials Acetal copolymer for main phantom, PVC rods (bone equivalent) (6) Ø 1mm stainless steal balls embedded into the surface of the phantom (1) Ø 6.4mm aluminum oxide ball embedded at the center of the phantom Standards 93/42/EEC 6

9 Features and Specifications continued 7

10 Notes 8

11 Service Policy Customer Responsibility If service, including recalibration, is required, please contact Standard Imaging s Customer Service department by phone or prior to shipping the product. Standard Imaging s Customer Service and Technical Service staff will attempt to address the product issue via phone or . If unable to address the issue, a return material authorization (RMA) number will be issued. With the RMA number, the product can be returned to Standard Imaging. It is the responsibility of the customer to properly package, insure and ship the product, with the RMA number clearly identified on the outside of the package. The customer must immediately file a claim with their carrier for any shipping damage or lost shipments. Return shipping and insurance is to be pre-paid or billed to the customer, and the customer may request a specific shipper. Items found to be out of warranty are subject to a minimum service fee of 1 hour labor (excluding recalibrations) for diagnostic efforts and require a purchase order (PO) before service is performed. With concurrence from customer, the product may be replaced if it is unserviceable or if the required service is cost prohibitive. Products incurring service charges may be held for payment. Standard Imaging does not provide loaner products. See the Standard Imaging Warranty and Customer Responsibility for additional information. Serialization Information Standard Imaging products that are serialized contain coded logic in the serial number which indicates the product, day and year of manufacture, and a sequential unit number for identification: A YY DDD X A YY DDD X Unique product ID Last two digits of the year (e.g = 99, 2000 = 00) Day of the year (1< DDD < 365) Unique unit ID Number (1 < X < 9) This product and its components will perform properly and reliably only when operated and maintained in accordance with the instructions contained in this manual and accompanying labels. A defective device should not be used. Parts which may be broken or missing or are clearly worn, distorted or contaminated should be replaced immediately with genuine replacement parts manufactured by or made available from Standard Imaging Inc. CAUTION: Federal law in the U.S.A. and Canadian law restrict the sale, distribution, or use of this product to, by, or on the order of a licensed medical practitioner. The use of this product should be restricted to the supervision of a qualified medical physicist. Measurement of high activity radioactive sources is potentially hazardous and should be performed by qualified personnel. WARNING: Proper use of this device depends on careful reading of all instructions and labels. WARNING: Where applicable, Standard Imaging products are designed to be used with the versions of common radiation delivery devices, treatment planning systems and other products or systems used in the delivery of ionizing radiation, available at the time the Standard Imaging product is released. Standard Imaging does not assume responsibility, liability and/or warrant against, problems with the use, reliability, safety or effectiveness that arise due to the evolution, updates or changes to these products or systems in the future. It is the responsibility of the customer or user to determine if the Standard Imaging product can be properly used with these products or systems. Should repair or replacement of this product become necessary after the warranty period, the customer should seek advice from Standard Imaging Inc. prior to such repair or replacement. If this product is in need of repair, it should not be used until all repairs have been made and the product is functioning properly and ready for use. After repair, the product may need to be calibrated. The owner of this product has sole responsibility for any malfunction resulting from abuse, improper use or maintenance, or repair by anyone other than Standard Imaging Inc. The information in this manual is subject to change without notice. No part of this manual may be copied or reproduced in any form or by any means without prior written consent of Standard Imaging Inc. 9

12 Warranty Standard Imaging, Inc. sells this product under the warranty herein set forth. The warranty is extended only to the buyer purchasing the product directly from Standard Imaging, Inc. or as a new product from an authorized dealer or distributor of Standard Imaging, Inc. For a period provided in the table below from the date of original delivery to the purchaser or a distributor, this Standard Imaging, Inc. product, provided in the table is warranted against functional defects in design, materials and workmanship, provided it is properly operated under conditions of normal use, and that repairs and replacements are made in accordance herewith. The foregoing warranty shall not apply to normal wear and tear, or if the product has been altered, disassembled or repaired other than by Standard Imaging, Inc. or if the product has been subject to abuse, misuse, negligence or accident. Product Standard Imaging Ionization Chambers Standard Imaging Well Chambers Standard Imaging Electrometers Standard Imaging BeamChecker Products Standard Imaging Software Products All Other Standard Imaging Products Standard Imaging Custom Products Standard Imaging Remanufactured Products Standard Imaging Custom Select Products Consumables Serviced Product Resale Products ADCL Product Calibration Warranty Period 2 years 2 years 5 years 2 years 1 year 1 year 1 year 180 days 90 days 90 days 90 days As defined by the Original Equipment Manufacturer 0-90 days = 100% of ADCL Calibration Costs days = 75% of ADCL Calibration Costs days = 50% of ADCL Calibration Costs days = 25% of ADCL Calibration Costs (days from date of shipment to customer) Standard Imaging s sole and exclusive obligation and the purchaser s sole and exclusive remedy under the above warranties are, at Standard Imaging s option, limited to repairing, replacing free of charge or revising labeling and manual content on, a product: (1) which contains a defect covered by the above warranties; (2) which are reported to Standard Imaging, Inc. not later than seven (7) days after the expiration date of the warranty period in the table; (3) which are returned to Standard Imaging, Inc. promptly after discovery of the defect; and (4) which are found to be defective upon examination by Standard Imaging Inc. Transportation related charges, (including, but not limited to shipping, customs, tariffs, taxes, and brokerage fees) to Standard Imaging are the buyer s responsibility. This warranty extends to every part of the product except consumables (fuses, batteries, or glass breakage). Standard Imaging, Inc. shall not be otherwise liable for any damages, including but not limited to, incidental damages, consequential damages, or special damages. Repaired or replaced products are warranted for the balance of the original warranty period, or at least 90 days. This warranty is in lieu of all other warranties, express or implied, whether statutory or otherwise, including any implied warranty of fitness for a particular purpose. In no event shall Standard Imaging, Inc. be liable for any incidental or consequential damages resulting from the use, misuse or abuse of the product or caused by any defect, failure or malfunction of the product, whether a claim of such damages is based upon the warranty, contract, negligence, or otherwise. This warranty represents the current standard warranty of Standard Imaging, Inc. Please refer to the labeling or instruction manual of your Standard Imaging, Inc. product or the Standard Imaging, Inc. web page for any warranty conditions unique to the product. 10