SPECIFICATION. SPECT/CT Gamma Camera System

Transcription

1 1. Scope SPECIFICATION SPECT/CT Gamma Camera System This specification describes the requirements for a dual-head SPECT/CT Gamma camera and work station solution (hereinafter referred as the System ), to be installed at the University Hospital of West Indies in Kingston, Jamaica (hereinafter referred as the End-User ) in the framework of the Technical Cooperation project JAM6012 (Re-Establishing Nuclear Medicine Capacity). The System will be located in a hospital setting and will be used for standard SPECT/CT and CT imaging as follows: SPECT for: a full range of nuclear medicine techniques using static, dynamic, WB, SPECT and ECG gated methodologies for orthopaedic, cardiology, neurology and oncological referrals; and Paediatric imaging. CT for: Diagnostic spiral CT for SPECT attenuation correction, localisation and full diagnostic, including ultra-low dose techniques and calcium scoring. 2. Applicable Documents The following documents shall be applicable for this Specification to the extent specified hereinafter: 2.1. NEMA NU Performance Measurements of Gamma Cameras ( and%20scope%20nema%20nu% pdf); 2.2. IAEA Human Health Series No. 6 - Quality Assurance for SPECT Systems ( SPECT-Systems); 2.3. IAEA Human Health Series No Quality Assurance Programme for Computed Tomography: Diagnostic and Therapy Applications ( Computed- Tomography-Diagnostic-and-Therapy-Applications). 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: ADC Analog to Digital Converter CFOV Central Field of View COR Centre of Rotation CT Computed Tomography CT-AC Computed Tomography Attenuation Correction 1

2 4. Requirements DICOM Digital imaging and communications in medicine ECG Electrocardiogram FBP Filtered Back Projection FWHM Full Width at Half Maximum HIS Hospital information NEMA National electrical manufacturer s association PACS Picture Archiving and Communication System PMT Photomultiplier Tube QC Quality Control RIS Radiology information SPECT - Single Photon Emission Computed Tomography SPR Scan Projection Radiograph UFOV Useful Field of View UPS Uninterruptible power supply WB Whole Body FAT Factory Acceptance Test SAT On site Acceptance Test 4.1. Functional and Performance Requirements The System shall meet the following functional and performance requirements: Ultra-fast cardiac acquisition with hardware and software to reduce patient dose and exam time to up to 4 minutes (The Contractor shall describe their technique in the proposal) Be capable of combining a variable angle and variable geometry dual-head SPECT gamma camera with diagnostic CT scanner; Be capable to obtain independently SPECT and CT images or both in combination (SPECT/CT); Be capable to perform non-uniform attenuation correction using CT attenuation maps acquired in the same, for cardiac and general SPECT imaging; Include at least two (2) processing/viewing stations; Be fully compatible with the End-User s currently available PACS/DICOM ; Have high resolution, parallel hole, pinhole, low, medium and high energy collimators and include Collimator cart/trays.; Have ECG trigger capabilities and be able to acquire all general SPECT, planar, static, dynamic acquisitions and CT; Include a full software package of diagnostic software; Include all software packages to allow for fastest acquisition for cardiac SPECT and SPECT/CT both gated and non-gated; Software shall have programmability and support to allow user defined programs to be developed, example: MPE capability and utilize pt. data; The acquisition protocols shall support all identified processing programs; Have adequate connection and compatibility to color and film printer; Allow fusion with PET, MR and/or CT data from external PACS access. 2

3 4.2. Technical requirements The System shall meet the following technical requirements and include: Detectors: Two rectangular detectors with NaI(Tl) scintillation crystals; Detector crystal thickness of 3/8 in (9.5 mm); UFOV of (38 to 39)cm x (51 to 53) cm; At least 55 high quantum efficiency PMT per each head, characterized by energy resolution, magnetic shielding and long- term stability, with 1 ADC/PMT; The System shall be able to image at energies between kev, including the possibility to acquire the data in multiple energy windows, both centred on photopeak and offset; Detectors shall be adequately shielded; At least one of the two detectors shall allow for caudal/cephalic tilt Collimators: One set of Low Energy (Tc-99m) High Resolution collimators One set of Medium Energy (In-111, Ga-67, Lu-177) General Purpose collimators One set of High Energy (I-131) General Purpose collimators One Pinhole collimator with 4mm and 6mm apertures Cart (or carts) for all collimators Gantry: The gantry shall support variable angle configurability of the detectors including 90 and 180 ; Patient part diameter/aperture of at least 70 cm; Gantry-mounted persistence display screen to assist in patient positioning; The System must incorporate the ability to acquire contoured and uncontoured WB imaging, and circular and elliptical (contoured) SPECT acquisition; Remote hand control for heads and table movement Patient table: The patient table shall be composed of a low attenuation pallet and a soft mattress; The patient table shall have motorized vertical motion activated from the hand control; Maximum patient load shall be at least 180 kg; Whole body scan length shall be at least 200 cm; Patient table shall allow examination of seated and standing patients and patients on wheelchairs; Minimum patient table height shall be 55cm for easy loading/ unloading of patients; Rear bed patient pallet support for minimizing of deflection; Pediatric pallet and immobilization kit for paediatric patients; 3

4 Touch screen flat panel monitor for patient positioning display, and display of different acquisition parameters (time, count rate and also information about detector and patient table position; Integrated ECG in patient table Safety features: Emergency stop buttons on gantry and patient table; Patient contact sensors (touch plates) mounted on each collimator Gantry linked to the patient table and with necessary sensors to recognize the patient table position at all times to prevent accidental collisions Acquisition workstation: Independent acquisition workstation to be placed in the control room, with hardware and software for SPECT and CT acquisition, quality controls and display LCD monitor of at least 19 in Acquisition of a wide spectrum of studies shall be possible, including: Planar static Planar dynamic WB SPECT ECG gated planar and SPECT SPECT/CT CT scanner: The CT must be integrated, spiral, fully diagnostic, multi-slice, with minimum 2 slices; The System must provide CT data collection in support of both SPECT/CT fusion for multi-modality imaging and validated CT- AC SPECT; D CT dose modulation; The possibility of sub 1 mm slice thicknesses in Axial Mode; The minimum CT slice thickness during spiral acquisition mode shall be < 1 mm; Patient part diameter/aperture of at least 70 cm; FOV of at least 50 cm; Maximum voltage of at least 130kV; Tube current in range ma; Maximum SPR length of at least 160 cm; SPR scanning projections: anterior-posterior (AP), posterior- anterior (PA), lateral (LAT); Time of one rotation during spiral scanning, maximum 1 s; The System shall be capable of automatically matching the CT slice thickness to the SPECT slice thickness for accurate image fusion and attenuation correction Processing workstation: The processing workstation for NM and CT images must be of the latest technology, with adequate storage capacity and be separated from the acquisition workstation; 4

5 Full DICOM 3.0 compatibility (send/receive, print, archiving, query/retrieve, work list) with RIS/HIS and PACS connectivity to the currently available at the End-User location; CD-DVD RW drive with ability to archive data to CD and DVD in DICOM Part10 format; LCD color monitor, min. 24 and 1920x1200 resolution; Adequate connection and compatibility to color and film printer (such as CODONICS); Shall allow fusion with PET, MR and/or CT data from external PACS access Software: Clinical processing software and comprehensive protocols for a wide spectrum of static, dynamic, WB, SPECT and ECG gated SPECT studies, including: Static renal imaging Dynamic renal imaging (renogram) Myocardial perfusion imaging Gated cardiac blood pool imaging (MUGA) Cardiac first pass imaging Cerebral perfusion imaging Lung ventilation and perfusion imaging Parathyroid imaging Gastric emptying Esophageal imaging Emory tollbox or 4DM SPECT Condensed dynamic images Ability to register CT images to: correct for motion between SPECT and CT imaging (particularly for cardiac applications); and to facilitate the use of CT images taken in different scanning sessions; FBP and Iterative reconstruction incorporating validated algorithms for measured and calculated attenuation correction, scatter correction, and compensation for detector response; Ability to correct for the presence of metal prosthesis in CT attenuation correction; Ability to correct for the presence of i.v. contrast in CT attenuation correction; Software needed for QC and calibrations of the, including: Energy calibration (peaking) PMT tuning Uniformity COR Accuracy of co-registration of SPECT and CT images Daily QC/calibration of CT Ancillary equipment: ECG trigger; A means of support for the patient s shoulders and arms such as is used for myocardial SPECT; Low-attenuation removable head support for brain SPECT permitting 5

6 immobilization of the head; Equipment and phantoms needed to perform manufacturer's defined quality control tests and calibrations, such as: Energy calibration (peaking) PMT tuning Uniformity COR Accuracy of co-registration of SPECT and CT images Daily QC/calibration Phantom for CT Color laser printer (at least 2400 dpi resolution) with network connection; UPS shall be included to protect the System from voltage surges and rapid voltage changes. It shall also provide support for adequate time to allow for proper shut-down of the System (at least 5 minutes in standby mode) NEMA performance parameters: Intrinsic flood field uniformity with 20% energy window and 20kcps for Tc- 99m UFOV Integral<= 3.8% UFOV Differential <= 2.8% Intrinsic energy resolution (FWHM) at 140 kev:<10%; Intrinsic spatial resolution (FWHM) with 20% energy window and 20kcps for Tc-99m; UFOV<4.1 mm; CFOV<3.8 mm Count rate at 20% count loss: > 300 kcps; For CT: High contrast spatial resolution better than14 lp/cm; Image Uniformity: ±10 HU for head and body; HU/CT number accuracy better: 0 ± 5 HU for water and 0 ± 10 HU for other materials. The System shall be of the current newest version, state of the art and not be obsolete within five (5) years of its installation. The Contractor shall be responsible for upgrading the System otherwise. 4.3 Optional Requirements 5. Marking At the option of the IAEA, the Contractor shall also supply and deliver the following: Jaszczak SPECT Phantom; Four quadrant bar phantom; Rectangular Co-57 flood source with activity of at least 555 MBq on the day of delivery to the hospital. The active dimensions of the flood source shall be adequate for the detectors size; Fully- or semi-automatic collimator exchange ; Ability to perform CT iterative reconstruction. The System shall have all safety markings in English language. 6

7 6. Packing The System, for the shipment by air/surface to the End-User, shall be packed in accordance with international standards that are applicable for the shipment by air/surface 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 or an equivalent quality assurance The Contractor shall document the compliance with this quality assurance. 8. Testing and Acceptance 8.1. Factory Acceptance Test (FAT) The System, prior to shipment, shall be tested for conformance of the System with manufacturer s performance specifications and the minimum requirements specified herein On site Acceptance Test (SAT) 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 Document that shall be signed by the End-User. 9. Installation and Training 9.1 The Contractor shall install the System at the End-User location. The Contractor shall be responsible for installation and commissioning of the System, including the costs of floor repair, in case of damage, at the installation site. The End-User will provide the enabling works and services specified in the Contractor s planning documentation to points of connection within one (1) meter of the location specified in the Contractor s Final Site Specific Drawings. The Contractor shall be responsible for any costs to be incurred due to additions to/deviations from the requirements specified in the Final Site Specific Drawings. 9.2 The Contractor shall provide one (1) week on-site training to up to five (5) staff of the End- User in the use of the System. The Contractor shall also provide factory training for one (1) in-house biomedical engineer, employed by the End-User, for the purpose of maintaining and quality control of the System to service level 2. Such training shall be equal to the training provided to the Contractor s /manufacturing company s own service staff. The Contractor shall provide, as its preference, site visit for up to two (2) End- User staff to an institution with identical System that has been in clinical operations for at least six (6) months (and preferably more than one (1) year). 10. Deliverable Data Items The Contractor shall provide two (2) complete sets of Operation and Servicing Manuals and Technical Drawings in hard copies and one (1) in electronic version in the English language. The Contractor shall provide Final Site Specific Drawings no later than four (4) calendar weeks 7

8 after the signature of the Contract. 11. Maintenance and Spare Parts Maintenance The Contractor shall also provide on-site full maintenance services for one (1) year during the warranty period, for the proper functioning of the System. Full maintenance services shall include: - preventative maintenance - on-call interventions - any software update/upgrade for the System that will become available - all necessary replacement and spare parts, if not covered under warranty At the End-User request, the Contractor shall provide up to five (5) additional years of maintenance services following the initial one (1) year full warranty referred to above. The End-User shall be responsible for the costs associated with such additional years of maintenance services. 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. The Contractor shall ensure that a suitable qualified person shall be on- Site within fortyeight (48) hours following an unexpected breakdown and shall solve the problem within the next twenty-four (24) hours during the warranty period Spare parts Upon installation, an initial set of essential spare parts for one (1) year during the warranty period shall be provided by the Contractor to be stored at the End-User s site. A list of available spare parts and prices shall subsequently be provided to the End-User and updated as necessary. 8