SPECIFICATION DIGITAL MAMMOGRAPHY UNIT AND ASSOCIATED SERVICES

Transcription

1 1 Digital Mammography Unit 1. Scope SPECIFICATION DIGITAL MAMMOGRAPHY UNIT AND ASSOCIATED SERVICES This specification describes the requirements for a digital mammography equipment and associated services (hereinafter referred as the System ) to be installed at the Georgian National Screening Center (hereinafter referred as the End-User ) for support of the screening program which has been implemented since 2008 and provided free breast cancer examination services for Georgian citizens. 2. Applicable Documents The following documents shall be applicable for this Specification to the extent specified hereinafter: 2.1. International Electrotechnical Commission, Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots, IEC ed4.0 ( ) International Electrotechnical Commission, High-voltage cable plug and socket connections for medical X-ray equipment, IEC ed2.0 ( ) International Electrotechnical Commission, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. IEC ed2.1 Consol. with am1 ( ) 2.4. International Electrotechnical Commission, Medical electrical equipment - Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices, IEC ed3.0 ( ) 2.5. International Electrotechnical Commission, Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis, IEC ed3.0 ( ) 2.6. IEC ed3.0 ( ) 2.7. International Electrotechnical Commission, Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids, IEC ed3.0 ( ) 2.8. International Electrotechnical Commission, Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography, IEC ed1.0 ( ) 2.9. International Electrotechnical Commission, Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography, IEC ed1.0 ( ) International Atomic Energy Agency Safety Standards, General Safety Requirements Part 3 (GSR Part 3), Radiation Protection and Safety of radiation sources: International Basic Safety Standards, Vienna (2014) International Atomic Energy Agency, Human Health Series 17, Quality Assurance Programme for Digital Mammography, IAEA, Vienna (2011) International Atomic Energy Agency, Human Health Series 2, Quality Assurance Programme for Screen-Film Mammography, IAEA, Vienna (2009) pub.iaea.org/books/iaeabooks/7991/quality-assurance-programme-for-screen-film- Mammography Page 1 of 1

2 2.13. All other applicable International Electrotechnical Commission Standards and 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. 3. Definitions, Acronyms, and Abbreviations The following definitions, acronyms, and abbreviations shall apply throughout this Specification unless defined otherwise hereinafter: BSS: International Atomic Energy Agency Safety Standards, General Safety Requirements Part 3 No. GSR Part 3, Radiation Protection and Safety of radiation sources: International Basic Safety Standards, IAEA, Vienna (2014). 4. Requirements 4.1. Functional and Performance Requirements The Contractor shall provide a complete package consisting of: - Digital mammography system, - Image processing and diagnosis workstation, - associated safety equipment Technical Requirements The System shall meet as a minimum the following technical requirements: Digital mammography system with: X ray generator X ray tube Acquisition Workstation/Operation Console Digital detector Image processing and diagnosis workstation Various software Uninterruptible Power Supply (UPS) Item/component Requirement # General characteristics State of the art digital mammography system Advanced high-end digital mammography machine which allows fast, low-dose, high-quality imaging of the breast Certification ISO and CE certification 2 1 Page 2 of 2

3 Power 5.0 kw 3 Tube voltage range (minimum) kvp (max. 1kVp step) 4 X ray generator Tube load range At least mas 5 Automatic Exposure Control (AEC) Manual and automated selection of kvp, mas, filter 6 Exposure time range At least 30ms - 2s 7 Anode material Materials shall be such to allow for low 8 dose/high penetration spectra, even for thick or Filter material dense breast. 9 X ray tube Focal spots 2 (approx. 0.3mm and 0.1mm) Both manual and automated selection of the focal spot shall be available. 10 Anode heat capacity At least HU 11 General Operator controls A separate workstation for image positioning and patient demographic data is required. Both detector and generator controls integrated in the same console Exposure parameters setting Both manual and fully automatic 14 Computer system System of latest technology (processor generation/type/speed, RAM, hard disc, storage systems, etc) 15 Acquisition workstation (AWS) Storage Capacity Minimum 5000 patients, both projections, both breasts Monitor High resolution flat panel min. 3 MP Time between sequential acquisitions Time between actual acquisition and preview on the AWS < 30 s 18 < 15 s 19 Patient dose display and record Dose index shall be displayed for each exposure and recorded 20 Page 3 of 3

4 DICOM functionality and connectivity Image processing DICOM 3.0 Print Service Class User DICOM 3.0 Storage Service Class User DICOM 3.0 Storage Commitment Class DICOM 3.0 Worklist Service Class User DICOM 3.0 Query/Retrieve DICOM 3.0 MPPS Image analysis tools shall be available (e.g. mean, standard deviation, a region of interest (ROI) tool with adjustable size and shape) Ability to perform repeat/reject analyses 23 Additional capabilities Special processing for implants 24 Ability to add comments to an image 25 Hand/foot switches Radiation protection barrier dimensions Radiation protection barrier thickness Double hand switch for the exposure and double foot switch for breast compression/ arm movements shall be available Adequate dimensions to protect the operator. Dimensions shall be provided Adequate thickness to protect the operator. Lead equivalence (mmpb) shall be provided Collimators Fully Automated Adjustment for different paddles, sizes and magnification 29 Movements Motorized vertical and rotating movement 30 Arm locking system Electromechanical brakes or equivalent 31 Arm moving system Motorized 32 Control buttons for vertical and rotational movement On both sides of C-arm 33 Gantry / tube head Focal spot to image detector distance (SID) > 65 cm 34 Patient face shield Patient face shield for 2D imaging. 35 Breast compression Manual and automated breast compression. Max. force for automated: 150 N and 200 N. Emergency release. Automatic decompression after exposure. 36 Digital numerical both sides indicator For C-arm rotation angle and compression force 37 Memorizable MLO angle Page 4 of 4 C-arm shall be able to stop automatically at contra lateral angle 38

5 Scatter rejection Antiscatter grid (or equivalent technology) 39 Magnification views At least one magnification view. Magnification ratio shall be provided 40 Antiscatter grid removal Automatic, motorized for magnification views 41 Shifting paddle Available 42 Screening breast paddles 18x24cm and 24x30cm 43 Paddles Small breast, spot and magnification paddles shall be included 44 Detector type State of the art technology direct conversion flat panel detector (a-se or similar) 45 Effective field size At least equivalent to 24x29 cm 46 Digital detector Pixel size < 100 µm 47 Image depth At least 12 bit 48 System resolution > 7 lp/mm 49 Workstation System of the latest technology workstation class hardware (processor generation/ type/speed, RAM, hard disc, storage systems, etc) 50 Image processing and diagnosis workstation Monitors Two (2) diagnostic mammography approved monitors of at least 5MP and 21inch, with automated self-calibration Display Graphic Card Hi End Medical Grade 52 Storage Capacity At least 1,5TB Workstation capabilities Mouse, Keypad Display of multiple images and priors for comparison purposes. Multi-modality viewer capability for display of ultra sound, x-ray, digital mammography, MRI, PET, CT on a third colour monitor. Dedicated keypad for mammography, common keypad, mouse Page 5 of 5

6 Software Dedicated breast imaging software with at least the following functions: magnifying, zooming, panning, windowing, brightness adjustment, contrast adjustment, distance measurement, histogram display, contrast enhancement, shall be provided. 56 Software and interconnectivity Display Capabilities Interconnectivity One-on-one image display: One pixel on detector corresponding to one pixel on monitor. Full DICOM 3.0 compatible: DICOM 3.0 Print Service Class User DICOM 3.0 Storage Service Class User DICOM 3.0 Query/Retrieve Media export/import Automated transfer of the image acquisition parameters (kilovolts (kv), milliampereseconds (mas), target and filter material, breast thickness, compression force, projection, L/R) for each exposure into the DICOM header Capability to export unprocessed and processed DICOM images Quality assurance phantoms/software Phantoms Phantoms and meters for the quality control and calibration of the various components (mammography, medical displays) of the systems shall be provided. 59 Power supply UPS Dedicated online UPS (for all workstations and accessories) shall be provided for a minimum backup time of 30 minutes Compliance to applicable international safety standards The Contractor shall provide evidence of compliance to international safety standards, mandatory requirement. 6. Marking The System shall have all safety markings in English. Page 6 of 6

7 7. 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. 8. Quality Requirements 8.1. 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. 9. Testing and Acceptance 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. The results of the testing of the System shall be documented by the Contractor in a Factory Acceptance Test Report to be provided to the IAEA before shipment to the End-User location. On site Acceptance Test (SAT) The System, after installation, shall be tested by the Contractor together with the End-User s medical physicist 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. A minimum of six (6) weeks prior to installation, the Contractor shall notify the IAEA, which retains the right to depute an IAEA representative to be present at the SAT. 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 s medical physicist and the Contractor s representative. This document shall be dated and accepted as the start of the System s warranty period. A copy of the Acceptance Document shall be sent to the IAEA. 10. Site preparation and readiness Notwithstanding any authorisation given by IAEA, the Contractor shall visit, inspect and ascertain that all necessary conditions are met at the End-User location before starting installation. Any comments, suggestion and additional requirements (structural, electrical) necessary for the installation of the system, shall be made at least four (4) weeks before the scheduled installation. The completion date of the Site preparation will be communicated by the IAEA to the Contractor in due time to start the installation. Page 7 of 7

8 11. Installation No installation activities shall be initiated unless authorised by the IAEA. Provided that the Site is ready and IAEA has given proper authorisation, the Contractor, in agreement with the End-User, shall install the System at the End-User location. The Contractor shall provide for this purpose all necessary tools and staff. 12. Training The Contractor shall provide at least three (3) days training for up to four (4) staff of the End- User in the operation and application of the System and its components at the End-User location immediately after the installation has been completed. The training shall be held in the English language. The Contractor shall provide personnel and tools as necessary for a proper training. 13. Deliverable Data Items The Contractor shall provide, before the start of the on-site training, two (2) complete sets of Operation and Servicing Manuals and Technical Drawings as necessary to perform maintenance/repair, in hard copies and one (1) in electronic version in the English language (and if available, in the local language). 14. 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 the Contractor shall provide, at the request of the End-User, up to five (5) additional years of maintenance services, following the initial one (1) year full warranty, including parts and labour costs. The related costs shall be borne by the End-User. 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 define in paragraph 15 below. The Contractor shall provide evidence of the capability to adequately provide technical support for the System in the future, in a timely manner, stating the network of official representatives in the Country and/or in the Region Spare parts Page 8 of 8

9 Upon installation, an initial set of essential spare parts shall be provided to be stored at the Site. A list of available spare parts and prices shall subsequently be provided and updated as necessary. 15. Uptime and penalties The Contractor guarantees that the System will have an up-time of at least 98% (excluding outages for maintenance or causes external to the System). Uptime is calculated on a basis of two hundred fifty (250) operating days per year (weekly working days). Should the down time exceed two (2) working days cumulative on a six (6) 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 System will be kept by a representative of the End-User at the Site. The Contractor shall have the right to request copies of such records. Page 9 of 9