SPECIFICATION CT SIMULATOR FOR BLACK LION HOSPITAL, ADDIS ABEBA, ETHIOPIA

Transcription

1 SPECIFICATION CT SIMULATOR FOR BLACK LION HOSPITAL, ADDIS ABEBA, ETHIOPIA 1. Scope This specification describes the requirements for the supply, delivery, installation, and acceptance testing of a CT Simulator for advanced simulation in planning conventional 3-D CRT and IMRT treatments at the Radiotherapy Department, Black Lion Hospital, AddisAbeba, Ethiopia. The supply of the CT Simulator should be done after the review of the hospital layout room by the contractor to ensure compliance to specifications. The delivery of this equipment is related to the IAEA-TC project ETH6015 Expanding Radiotherapy and Nuclear Medicine Services for the Diagnosis, Curative and Palliative Treatment of Cancer Patients and the Efficient Diagnosis and Treatment of Other Diseases. 2. Applicable Documents The following documents shall be applicable for this Specification to the extent specified hereinafter: - International Electrotechnical Commission, Medical Electrical Equipment, Part 1: General requirements for Safety, Rep. IEC 601-1, IEC, Geneva (1988) - International Electrotechnical Commission, Medical Electrical Equipment, Part 2-29: Particular requirements for the safety of radiotherapy simulators, Rep. IEC , IEC, Geneva (1999) - International Electrotechnical Commission, Radiotherapy simulators: Guidelines for functional performance characteristics, Rep. IEC 61170, IEC, Geneva (1993) - International Electrotechnical Commission, Medical Electrical Equipment: Requirements for the safety of radiotherapy treatment planning systems, Rep. IEC 62083, IEC, Geneva (2000) - Setting up a Radiotherapy Programme: Clinical, Medical Physics, Radiation Protection and Safety Aspects, IAEA, Vienna (2008) ( Page 1 of 7

2 - Radiation Protection andsafety of Radiation Sources:International BasicSafety Standards, IAEA, Vienna (2014) ( - Quality Assurance Programme for Computed Tomography: Diagnostic and Therapy Applications IAEA Human Health Series 19, Vienna (2012) ( Programme-for-Computed-Tomography-Diagnostic-and-Therapy-Applications) - All the applicable International Atomic Energy Agency Safety Standards. In the event of conflict between the documents listed above and the content of this Specification, the content of this Specification shall take precedence to the extent of the conflict. 3. Definitions, Acronyms, and Abbreviations The following definitions, acronyms, and abbreviations shall apply throughout this Specification unless defined otherwise hereinafter: Site: will mean the Radiotherapy Department, Black Lion Hospital, AddisAbeba, Ethiopia. System: will mean the entire CT Simulator to be provided under the Contract including all units, unless mentioned separately BSS: International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, IAEA, Vienna (1996) CCTV: closed circuit television system cm:centimetre CT: computed tomography SPR:scan projection radiograph 4. Requirements 4.1. Functional and Performance Requirements The System shall meet the following functional and performance requirements: Page 2 of 7

3 The simulator shall be a CT scanner for radiotherapy treatment simulation The CT scanner shall have a carbon fibre flat table-top with indexing facilities (for all kinds of immobilization system used in radiotherapy) identical to that of linear accelerators and/or cobalt teletherapy units at the Site The CT scanner shall have conventional in-built lasers or light beams, which indicate the coincidence of the centre of rotation and scan position An external radiotherapy laser system shallbe incorporated to provide reference marks on patient skin or on any immobilization device. It is desirable for the external lasers to have easy alignment adjustability and to have positional stability with time The entire CT Simulation system must be interconnected (all the workstations, any laser systems, printers etc.) and the CT scanner shall be capable of being networked with all radiotherapy treatment planning systems at the Site to allow transfer of CT data sets to the treatment planning systems in DICOM format Technical Requirements The System shall meet the following technical requirements: CT Scanner: The CT scanner shall be a whole body spiral, multi-slice (minimum 6 slices per rotation) CT scanner; Gantry: A gantry aperture of at least 80 cm. Scan field of view of at least 50 cm. Extended field of view of minimum 70 cm for radiotherapy planning should be available. The positioning indicators in the gantry must have a positioning accuracy of ± 1 mm or better; Couch:The couch top material must be carbon fibre, flat bed type, with minimum dimensions of 235 cm x 40 cm, having horizontal moving range of 170 cm or more. The speed of horizontal movement must be variable with a maximum speed of at least 100 mm per second. The accuracy (reproducibility) of the table top must be better than ± 0.25 mm. The scannable range should be at least 120 cm. It must be able to take a maximum weight of 180 kg or more without any change in stated performance specifications (such as the positioning accuracy) X-ray System: High frequency X-ray generator with power rating of at least 50 kw. kvp should be in the range of 80 kv to 140 kv. The ma range from 30 ma to 400 ma, with step size of 5 ma or better. Peak anode heat dissipation rate of at least 800 khu / min or better. The X-ray tube should have dual focal spots. Please state the size of the focal spots; Detectors: The detector system should be a high performance, low noise, high data density, active response data acquisition system. The detectors should be solid state. The detector system should be free from repeated calibrations. There should be multiple rows of 650 or more detectors for taking a minimum of 6 slices at a time; Scan parameters: Slice thickness should be at least sub-millimetre. Scan time of 0.6 second or less for full 360 degree rotation. Retrospective reconstruction should be possible on raw data files with change in Page 3 of 7

4 parameters such as FOV. Starting with a cold tube, the maximum helical scan distance using a 3 mm imaged slice thickness and a pitch of 1.5 should be 1500 mm or more. The following scanning modes should be possible: SPR, axial, and spiral. The SPR length should be more than 1500 mm long and the width must be at least 500 mm. It must be possible to obtain the SPR from AP or PA or left to right or right to left directions. The ability of the system to reproduce the scanning protocol from the SPR should be ± 3 mm or better. The accuracy of distance measurements in the SPR (taken at isocenter distance) must be better than twice the pixel dimension. Different selection of pitch should be possible, from 0.5 to 3 in 0.1 increments. State the pitch available. State the single run coverage and the table scannable range. Intra-plan delay of 5 sec or more should be possible. The system must have automatic ma control software that automatically adjusts ma for patient size, adjusts ma along the z-axis, and modulates ma during rotation; Image Quality: The reconstruction matrix must be 256 x 256 or higher. Simultaneous scanning and reconstruction should be possible. It should be possible to do: Simultaneous scanning & routine analysis, Simultaneous scanning & archiving and / or hard copying and Simultaneous scanning and transfer to second console / workstation. High contrast spatial resolution: at least 15 lp/cm maximum at 0% modulation transfer function (MTF). Low contrast detectability: 5 mm or 0.3% using adequate phantom on 10 mm slice thickness. The CT number accuracy must be better than 0 ± 4 HU for water and ± 5 HU for air; Computer System for the CT scanner: A high end main computer system must be provided. There must be two monitors at the console and they must be 19" or more TFT flat screen LCD monitors. One of these will be used for acquisition and the other will be used for review and processing. The hard disk capacity of the main computer system should be at least 100 GB or more. In the hard disk meant for image storage, the number of uncompressed 512 x 512 images that can be stored should be at least 200,000 or more. The maximum possible hard disk capacity must be provided. For archiving, DVD writer should be provided for providing copies of individual studies. All necessary hardware and consumables (DVD / DAT cartridges) to be specified and provided. The CT-Simulator system should be fully DICOM complaint. The DICOM should support the following: DICOM 3.0 Print service class as a user, DICOM 3.0 Storage class as a user, DICOM 3.0 Storage class as a provider, DICOM 3.0 Send / Receive, DICOM 3.0 Query / Retrieve service class as a user, and DICOM 3.0 Query / Retrieve service class as a provider. DICOM compliance statement should be provided; Audio:A bi-directional speaker communication must be provided between the operator and the patient; Quality control equipment: Necessary phantoms to check the image quality and calibration of the CT scanner should be provided. A phantom should also be provided to check the accuracy of the position of the external radiotherapy lasers; and Page 4 of 7

5 External Radiotherapy Laser System: An external radiotherapy laser system for patient alignment, marking and isocentre localisation shall be provided. The external laser system should including a moveable sagittal laser and fixed or moveable lateral lasers. It is desirable for the external lasers to have easy alignment adjustability and to have positional stability with time. Laser projection should also be at least 50 cm long at the patient plane. Red lasers are preferred Essential accessories to be included with the System UPS: On line UPS with MF batteries for the backup of the entire system for at least thirty minutes; LASER Camera: A dry laser camera is to be provided; Lead Glass: 120cm x 150cm (control consol s window is 110cm x 120 cm ) or more with lead equivalent; Dose computation & display: The system should display CTDIw and DLP Optional CT simulation software CT (virtual) simulation software is a package that may be available with some CT scanners and is used as an interface between the CT scanner and the radiotherapy treatment planning software. The most important features of the virtual simulator are fast CT scanning and reconstruction of transverse slices, fast reconstruction of any section, automatic skin outlining, automatic lung/bone outlining, semi-automatic outlining of critical structures/vital organs, user friendly target outlining (accurate interpolation/ease of editing) and volumetric growing of margins using a true 3D volume growing algorithm. 5. Marking The System shall have all safety markings in English language. 6. Packing The System, for the shipment by air to the End-User, shall be packed in accordance with international standards that are applicable for the shipment by air of this kind of equipment. 7. Quality Requirements 7.1. The System shall be manufactured, shipped and installed in accordance with the Contractor s ISO quality assurance system or an equivalent quality assurance system The Contractor shall document the compliance with this quality assurance system. Page 5 of 7

6 8. Testing and Acceptance The System, prior to shipment, shall be tested for conformance of the System with manufacturer s performance specifications and the minimum requirements specified herein. The System, after installation, shall be tested by the Contractor together with the End-User to demonstrate that the performance meets the manufacturer s performance specifications and the minimum requirements specified herein as determined by the IAEA and the End-User. The results of the testing of the System shall be documented by the Contractor in an acceptance protocol that shall be signed by the End-User. 9. Installation and Training The Contractor shall install the System at the Radiotherapy Department, Black Lion Hospital, AddisAbeba, Ethiopia. The Contractor shall provide up to one week training for up to three staff of the End-User in the operation and maintenance of the System at the End-User s location immediately after the installation of the System. 10. Deliverable Data Items The Contractor shall provide two complete sets of operation and servicing manuals and technical drawings in the English language. 11. Warranty The CT Simulator and all components shall be covered by standard warranty offered by the contractor including parts and labour, starting as of the date of successful on-site acceptance, as per Section 8 above. Warranty shall also cover hardware and software, including further upgrades and updates. Warranty shall include all necessary spare parts, shipment to site, cost of replacement (work, personnel etc.) and disposal of faulty parts. 12. Maintenance The Contract price includes full maintenance services during warranty period. Full maintenance services during the warranty period shall include: - preventative maintenance - on-call interventions - any software update/upgrade for the System that will be become available - all necessary replacement and spare parts Page 6 of 7

7 As part of the On-Site acceptance, the Contractor shall provide to the local engineer and to the hospital medical physicist a plan for preventative maintenance and the name and contacts of a service representative/office for on-call maintenance intervention. Intervention time shall be clearly defined and shall comply with the uptime requirements defined in section 13 below. 13. Uptime and Penalties The Contractor guarantees that the CT Simulator will have an up-time of at least 97% (excluding outages for maintenance or causes external to the System). Uptime is calculated on a basis of 250 operating days per year (weekly working days). Should the down time exceed 2 working days cumulative on a six months basis (i.e. summing up the hours), then the warranty and/or maintenance (as applicable) will be extended for a corresponding period. The records of downtime of the CT Simulator will be kept by a representative of Radiotherapy Department, Black Lion Hospital, Addis Abeba, Ethiopia at the Site. The Contractor shall have the right to request copies of such records. Page 7 of 7