PAGE 1 OF 18 PROPOSAL 2013 COUNTRY OF ORIGIN CATEGORY / SPEC STATUS QTY MODEL EQUIPMENT NAME LOCAL SUPPLIER MANUFACTURE R PRICE PER UNIT TOTAL PRICE

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1 SUPPLY, INSTALLATION, TESTING AND COMMISSIONING OF SINGLE PLANE FLAT DETECTOR ANGIOGRAPHY SYSTEM FOR KUALA TERENGGANU SPECIALIST HOSPITAL AT LOT 3963, JALAN SULTAN MAHMUD, KAMPUNG BATU BURUK, MUKIM BATU BURUK, KUALA TERENGGANU CATEGORY / SPEC STATUS EQUIPMENT NAME QTY MODEL MANUFACTURE R PROPOSAL 2013 COUNTRY OF ORIGIN LOCAL SUPPLIER PRICE PER UNIT TOTAL PRICE GROUP EQUIPMENT - ELECTRICAL RELATED Y SINGLE PLANE FLAT DETECTOR ANGIOGRAPHY SYSTEM 1 PAGE 1 OF 18

2 ITEM DESCRIPTION: MANUFACTURER: MODEL/BRAND: COUNTRY OF ORIGIN: S/N. Description of Function 1 2 Application This document is the technical and performance specifications for the supply, testing and commissioning of a Single Plane Flat Detector Angiography System that shall be compatible with all diagnostic and therapeutic intervention of cardiac imaging as well as providing an excellent image quality at lowest patient dose. Main Features 2.1 State of the art, ceiling mounted angiography system high resolution single plane Flat Detector Technology 2.2 Capable of real-time Digital Angiography (DA) and Digital Subtraction Angiography (DSA) acquisition. 2.3 High frame speed acquisition of up to 30fps 2.4 Capable of road mapping with zoom, freeze-frame 2.5 Capable of fluoro grabbing of fluoroscopic image for documentation 2.6 Interventional tool to improve visualization of stent placement before and after deployment during fluoroscopy in real time 2.7 Interventional tool to provide real time navigational guidance during the guidewires and devices advancement through the vasculature during percutaneous coronary interventions 2.8 Clinically validated cardiac and vascular programs. 2.9 Unlimited patients access from all sides for various techniques and procedures Integrated safety devices. Page 2 of 18

3 3 Technical Specifications 3.1 Generator It shall be multipulse, microprocessor control and high power generators with high frequency converter Power rating of at least: a. 100 kw at 80 kv, 1000 ma b. 100 kw at 100 kv, 1000mA c. 100 kw at 125 kv, 800mA Radiographic kv range: a. Lower limit shall not exceed 40kV b. Upper limit shall not be less than 125kV Radiographic ma range: a. Lower limit shall not exceed 10 ma b. Upper limit shall not exceed than 1000 ma Exposure timer range: a. Lower limit shall not exceed 1.0 ms b. Upper limit shall not be less than 3 seconds Fluoroscopic kv range: a. Lower limit shall not exceed 40 kv b. Upper limit shall not be less than 125 kv Fluoroscopic ma range: a. Lower limit shall not exceed 0.3 ma b. Upper limit shall not be less than 30 ma Pulse fluoroscopy rate: Shall be variable up to 30 pulses / second. Please list selectable pulse rates. Foot switched shall be provided Page 3 of 18

4 3.2 X-Ray Tube Type a. Anode Rotation system Min two focus spot system a. Small focus shall be approximately 0.5 mm b. Large focus shall be approximately 0.8 mm Power a. Small focus - power output at least 45 kw b. Large focus - power output at least 85 kw Anode heat storage capacity of at least 2.3 MHU Anode cooling rate of at least 900 khu/min Cu pre-filtration is used in all cardiac acquisition and DA/ DSA acquisition program. (Define the Cu thickness used) 3.3 C-Arm Type Ceiling mounted C-arm a. For emergency parking, the stand shall be able to be parked away from the patient table manually and by motorized movement allowing ample space for patient access round the table LAO/RAO rotation speed with at least 15 degrees/s motorised without restriction. a. With stand at head end: at least 120 /120 LAO/RAO b. With stand at 90 left/ right position: at least 45 /45 LAO/RAO c. C-arm rotation speed: Not less than 25 /sec with efficient and accurate collision detection system incorporated to ensure staff, patient and equipment safety. Able to sense actual patient size and adapts rotation speed accordingly for comfort and safety Page 4 of 18

5 C-arm angulation (Cranial/ Caudal) a. With stand at head end: at least 45 /45 Cranial/ Caudal b. With stand at 90 left/ right position: 120 cranial, 120 caudal c. C-arm rotation speed: Not less than 18 /sec with efficient and accurate collision detection system incorporated to ensure staff, patient and equipment safety. Able to sense actual patient size and adapts rotation speed accordingly for comfort and safety. Focus to FD distance (SID) as follows: a. Lower limit shall not exceed 90 cm b. Upper limit shall not be less than 120cm c. Shall allow motorized and manual SID movement Focus spot to iso-centre: Should not be more than 80cm Iso-centre to floor: Should not exceed 110cm C-ARM depth Not less than or equal to 105 cm Non-contact Anti-collision Safety mechanism shall be available Parking during emergency: One-touch button function for emergency parking of C-Arm Automatic positioning memories a. C-arm console b. Personalized to active user and procedure. Number of pre-program stand position of at least up to 50 different positions can be stored c. Programmable parameters: Rotation, angulation, SID and detector d. Roadmap driven positioning: Able to automatically position the stand to the position of the parameter setting of the roadmap image selected e. Selection of the APC program shall be quick and easy from the patient table side Page 5 of 18

6 3.4 Table Type Floor-mounted radio translucent floating top. It shall be able to cover full head to toe examination without repositioning the patient Table Top Length: Shall not be less than 300cm Table-top height: Shall be adjustable a. Lowest height: not more or equal to 75cm b. maximum height: not less or equal to 100cm Table-top width : At least 50 cm Transverse slide: At least +/- 17cm Longitudinal slide : At least 120 cm Table Top Pivot Movement: at least 270 with locking positions Supports weight up to 200kg plus additional 100kg for CPR with the table top in fully extended working position away from the table base Tableside control shall be detachable to position at any of the 3 sides of the table. Page 6 of 18

7 3.5 Flat Detector Type High quality state-of-art detector technology with Csl techology Detector size: Not less than 20 x 20cm Detector Pixel Size: Not more than 190µm Detector bit depth: Not more than 184µm Image Matrix : At least 1024 x 1024 at 14bits depth Detector quantum efficiency Not Less than 75% Detector spatial resolution Not less than 2.7 lp / mm 3.6 Image Display Examination room: Monitor Size and Quantity: At least 4 unit x 19 medical grade LCD monitors (for live, reference, hemodynamic and interventional tools display) Image Matrix: At least 1280 x 1024 On screen display at the examination room monitor to provide at least information on stand rotation, angulations, display of system messages, X-ray tube load status, selected fluoroscopy mode and selected detector field of view. Monitor Carriage: Flexible positioning at any sides of the table with motorized height adjustable at any position in the exam room. Column at least 330 rotating column Page 7 of 18

8 Control room: Two (1) 19" Monochrome TFT-LCD patient data management & image review and processing. Monitor Size: At least 19 Image Matrix: At least 1280 x 1024 At least TWO (2) TFT LCD Monitors for live hemodynamic and charting display (Refer to appendix 6.4) Monitor Size: At least Digital Imaging System Digital Angiography (DA), Digital Subtraction Angiography (DSA) capability and pulsed fluoroscopic acquisition capabilities High resolution imaging Capable of acquiring up to least 1024 x 1024 matrix. Acquisition Frame Rate: With variable frame rate of not less than 0.5fps 30fps Pulsed Fluoroscopy Frame Rate: With variable pulse rates of 7.5, 15, 30fps Fluoroscopy mode of at least three (3) selections at the table side of different preprogrammed dose rate and copper pre-filtration combinations for optimal balanced between dose and image quality Storage of a fluoroscopic run of at least 20 sec shall be possible and reviewable in cine loop DSA functions shall include the following: Real-time subtraction at all frame rates for fluoroscopy mode and acquisition mode Subtracted fluoro capability - roadmaping Page 8 of 18

9 Mask selection Land marking All the above functions must be easily selectable and operable inside the examination room from the table side Image Storage disc capacity: Not less than 100,000 images of 1024x1024 matrix, min 12 bits depth 3.8 Controls and user interface Tableside controls for all geometry, imaging parameters, procedure controls and processing functionality. An flexable control unit for image review, freeze, selection of roadmaps and image store shall be available. Patient management, acquisition and data management shall be controlled from one keyboard and mouse and supports workflow process of scheduling, preparation, acquisition, review and archiving. Image review and other post processing: (i) Shall be able to provide the following functions at the operator console as well as in the examination room: Variable view speed Forward / reverse Cine loop functions Window width and window level functions Image inversion Select roadmap image Pan / zoom enhancement Examinations overview of up to 16 images Individual images or runs can be selected for archive Free text annotation Background digital subtraction Land marking Pixel shift Re-marking Page 9 of 18

10 (ii) Quantitative Evaluation Software for coronary and vascular studies at control console a. Shall be clinically validated b. Automatic & manual vessel analysis, stenosis ratio measurement must be available at both the exam room and the control room. c. Automatic calibration shall be available d. Single click operation of quantitative coronary analysis at tableside is preferred (iii) Infra-red handheld remote controls for image review, freeze, selection of roadmaps and image store shall be available 2 units DICOM Print compatible and must be readily to DICOM print through network printers; as well as connectable, transfer and receive images from the existing PACS system DICOM 3 compatible and DICOM conformance statement shall be provided and included cost of connection with PACS system. 4 Advanced Interventional Tool Application Packages 4.1 Real-time enhanced visualization of coronary stent for pre and post-deployment: Shall provide a real time live visualization technology to improve stent deliverability and better stent definition and provide clear, enhance visibility to the vessel wall for post dilation and apposition of stents placement in pre- and post- deployment of peripheral procedures. Shall be able to view the enhanced stent in clear relationship to the vessel walls. Page 10 of 18

11 The enhanced stent image should be displayed in the examination room 19 inch monitor side-by-side to live x-ray images and reference images The enhanced stent image should be in fluoroscopic real-time and does not require post-processing. The manipulation and storing of the enhanced stent image shall be controllable at the tableside 4.2 Live Coronary guidance and road mapping Fusion of live fluoroscopy and angiogram image into a single adaptive roadmap image for the live coronary navigation The Live navigation shall provide immediate feedback on the position of the device and its relationship to the anatomy to guide navigation Automatic creation and storage of a dynamic roadmap from each acquired coronary angiogram and one roadmap per projection is stored Automatic overlay of the dynamic roadmap on live fluoroscopy without any image post processing needed Automatic guidance to reach projections for which a roadmap is available The live navigational image snapshots or movies can be archived to any DICOM compatible PACS 4.3 Quantitative Vascular and Coronary Analysis Automation contour detection of the coronary artery of interest and analysis of it dimension 7 DICOM COMPATABILITY 7.1 The system must be DICOM 3 compatible, ready physically with necessary hardware and software Following to be made available: DICOM Modality Work List SCU DICOM Modality Performed Procedure Step SCP Page 11 of 18

12 7.1.4 DICOM Storage Commitment SCU DICOM Print SCU DICOM Query and Retrieve System must be ready equipped with the necessary hardware for link to the dry DICOM laser printing without additional cost for interfacing 7.2 DICOM Conformance Statement shall be submitted 7.3 DICOM CD RECORDING Integrated review workstation (1 unit) allowing DICOM recording on CD or DVD for selected images or entire examination 7.4 The integrated workstation shall become as an offline review workstation as well 8. Essential Accessories 8.1 Mattress, tear resistant. 8.2 Carbon fibre translucent catheterisation arm set, bidder to specify. 8.3 Intravenous drip stand attachment at the table. 8.5 Patient resistant straps and restrainer boards, adult and children. 8.6 Patient transferring board (Pat Slide). 8.7 Ceiling suspended counter-balanced examination light suitable for cardiovascular procedures - daylight character with light density of 60,000 Lux. Complete with sterilisable handgrip for focusing & positioning, mobile and allows movement with ceiling rails. Automatic on-off switch to be in-corporated into the foot switch. 8.8 Ceiling suspended (with rails) lead shield - balance adjustable swing-arm for radiation protection of the head and neck region with flexible lead glass of complete with frame with 0.5mm Pb eq. protection. 8.9 Tableside lead shield - shall be able easily pivot to parking and working position with 0.5 mm Pb eq Light-weighted non-lead wrap around apron, double-sided of 0.35 mm Pb eq. protection.(2 Unit Size L, 1 unit size M) 8.11 Light-weighted non-lead vest and skirt lead gowns 0.35 mm Pb eq protection. (2 unit of size L and 1 unit size of M) 8.12 Lead apron hanger (5-in-1) Light-weighted non-lead thyroid shield 0.5 mm Pb eq. protection. (5 unit) 8.14 Panoramic lead spectacles 0.5 mm Pb eq. (5 Unit) 9. Power Requirements Page 12 of 18

13 V 50 Hz. 9.2 Shall have provisions for a separate battery / batteries for Uninterrupted Power Supply (UPS) and must be in line A least 30 minutes with screening time Angiography System and the examination light of 60,000 lux. 10. Training Shall install appropriate wiring for the above. On-site training shall be provided on the proper operation and application of the equipment. It shall be carried out by a qualified application specialist who is well versed with the model of equipment offered The duration of training shall be for a minimum of 15 working days in three (3) sessions. (i) (ii) (iii) The training shall be spread out over three visits Notwithstanding the above, further training shall be provided until such time that the end-users are well versed with the use of the equipment Staff training for the radiologist and radiographers shall be provided via 3 sessions: 10.3 a. 1st session during commissioning - 10 days b. 2nd session 3 months after commissiong - 5 days c. 3rd session 6 months after commissioning - 5 days The training shall include the operation, trouble-shooting, planned preventive maintenance and on diagnostic software of the machine concerned. 11 Site Works, Preparation and Installation 11.1 The sitting of the system shall be in a building to be located as indicated in the drawings attached The general requirements for site works and preparation shall be as outlined in the accompanying document which shall be in conjunction with and is in addition to the technical specifications of the equipment. The bidder shall be required to list all details of site works and preparation and provide costing breakdown. Page 13 of 18

14 12 Standard & Safety The performance of the unit shall confirm to IEC standards and all protection regulations in force for equipment generating ionizing radiation. It shall be tropicalised, licensed in Malaysia and meet the requirements of the Atomic Energy Licensing Act 1984 and its subsidiary regulations. 13 Maintenance & Services 13.1 The bidder shall state and provide details of the factory of manufacturer's recommended preventive maintenance schedule and cost of service contract for five (5) years post warranty The following shall be submitted: Comprehensive maintenance and services inclusive of parts and consumable. All components must be original and factory made Non Comprehensive maintenance service excluding parts and consumable. All components must be original and factory made Bidder shall give warranty that spare parts are available for at least 10 years Bidder shall provide all software upgrades free of charge Warranty: All equipment supplied shall be guaranteed for a minimum period of 24 calendar months following satisfactory installation, commissioning and handing over The bidder shall state and provide details of general and specific guarantees The bidder shall guarantee the availability of spare parts for a period of ten (10) years after satisfactory handing over for the equipment Software delivered shall be upgraded and maintained in current status at no additional cost to the hospital during the one (2) years warranty period and any subsequent maintenance period The bidder shall guarantee the ability to maintain all software supplies. Including any future upgrades or corrections to the software for a minimum period of eight (8) years after the completion of the support period Guarantee up time shall be 98% per 24 hours per 365 days. On site service for emergency calls: 1 hour Service personnel: Bidder to summit a list of service engineers and maintenance work force. Page 14 of 18

15 14 Service & Operator Manuals Two (2) complete sets of manuals on the operation and shall be supplied by the bidder The instruction shall cover the main as well as any associated equipment The instruction shall include essential details, drawings and sketches of the equipment installation, operation and maintenance techniques, mention of specific materials where utilized and include schedules of recommended lubricants, etc All manuals shall be in the National or English Language. 15 Other Requirements 15.1 Full information & supporting documents: Relevant information on the particular model of equipment offered shall be stated The bidder shall validate and substantiate all information provided in the offer either through original catalogues or other literature Model of equipment: The year the model of equipment offered was 1st introduced / produced shall be stated and record of sales shall be provided Scope of work: The work / supply covers but shall not be limited to the supply, delivery, installation, testing, commissioning and handing over the approved working order and maintenance thereafter for the period stated in the technical specifications It shall cover such minor works as are necessary for the proper carrying out of the installation and operation of the system, whether or not such works are specifically stated in the specifications and drawings The bidder shall offer all accessories essential for the equipment to be fully operational. These shall include computer software where applicable The equipment shall include any special tools or appliances required for the normal handling and maintenance of the equipment Local support & representation: Page 15 of 18

16 Local technical expertise available for the maintenance and repair of the particular model of equipment offered shall be listed showing names, identity cards numbers and proof of employment All components must be new, original and factory made All the installation must fullfill with all licensing requirement of MOH, AELB and/ or any other related authorities Renovation works shall be carry out and comply with requirements by CKAPS and/ or any other related authorities in terms of clinical, material, patient and staff flow Page 16 of 18

17 List Of Angiography System Accessories 1 Two-way hands free intercom system (should be from the same manufacturer - to avoid echos) i. 2 microphones + 1 Speaker (Control Room) ii. 1 microphone+ 1 Speaker (Examination Room) iii. 1 Amplifier 2 Single head High Pressure Contrast Injector for angio system with interfaced to the system provided - one (1) unit prefebably Nemoto or equivalent 3 Uninterrupted Power Supply (UPS) with at least 30 minutes for main system to enable fluoroscopy capabilities must be installed. It should have low noise emittance. 4 Accessory cabinet for ICL consumable. 5 External DAP meter for biplane 6 HEMODYNAMIC - ONE (1) UNIT i Hemodynamic Recording System - Maclab or equivalent. ii Able to monitor all required Haemodynamics parameters in a cath lab. Shall operate on Window platform with open architecture, multitasking and shall be able to network to Hospital backbones. iii A slave monitor in examination room of at least 18 LCD monitor shall be included. iv Shall have comprehensive Haemodynamic Analysis Software. v Shall have editable Coronary Tree and Vascular tree annotations with Standard Cardiac and Peripheral Templates linked to clinical database. vi Shall have Paediatric Congenital Heart Diagrams vii Shall have Time and Amplitude calipers viii Shall have Full disclosure for recording and storing all waveform data for post case review and analysis. Shall be of International AHA Configuration Shall be able to perform paperless charting Shall have variable sampling length and user defined between 5 and 120 seconds. Shall be able to perform electronic signatures. Bi-directional demographic data entry User customisable menu and report templates Image still frames can be placed in the procedure report Shall be able to generate the clinical report in pdf format and print on a standard A4 Laser Printer with both black & white and colour print of at least 17 ppm printing speed and resolution of 600 x 600 dpi. Complete with input tray of carrying not less than 250 sheets. The system shall be interfaced with hospital RIS, PACS / CIS and especially EP system. Vendor shall provide all essential hardware and software to ensure smooth integration without additional cost incurred.

18 7 Single Chamber Temporary Pacemaker Generator (user friendly) - Medtronics Model 5391 or equivalent 8 lntravascular Ultrasound (IVUS) for coronary artery imaging with 3rd party software for IVUS image analysis and reporting - One (1) unit Preferably Boston Opticross IVUS or equivalent. 9 Fluid Management Pendant - preferably Maquet Moduevo Slimline or equivalent 9A Able to support at least 12 electrical plug points. The following are required: i. Eight (8) UPS ii. Four (4) Essential supply 9B Able to support at least 10 medical gas outlets. The following are required: a. Two (2) oxygen outlets b. One (1) vacuum outlet c. One (1) nitrous outlet d. One (1) AGSS (Anaesthetic gas scavenging system) outlet e. One (1) compressed air outlet f. 2 Data points/ connection provided g. Attached stainless steel drip stand provided 10 ADDITIONAL ACCESSORIES i Long (- 92 cm length) stainless steel trolleys (without raised edge) - Four (4) units