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Tender For The Purchase Of Medical Equipments And Software Under Hub And Spokes Model - Software,Third Party Items (Including Civil Works And Other),Biplanar Dsa Unit - 1 System configuration a. Biplane Digital Flat Panel Cath Lab b. Patient Positioning X-Ray Table c. X-ray system complete with Generator, Flat panel detector, X-Ray tube & control for Biplane system d. TV monitors - at least 50" diagonal LCD- TFT monitor e. Additional 19-inch backup monitors in the DSA suite. f. Image Processing Unit and Image Data Storage. Image viewing unit that is independent of the console where live fluro is displayed for reviewing prior scans g. Control Console and Display Unit for C-Arm h. On-Line UPS System (Backup Time at Least 20 min) i. Lead Aprons, Thyroid Guards & Lead Spectacles j. The system should operate on a three-phase 400v ± 10%, 50hz mains power supply and have automatic voltage compensation and protection against power surges 2 C arm/Gantry a. The system should have two gantries: one floor mounted and one ceiling suspended providing full body coverage without repositioning the patient. The lateral plane should have motorized longitudinal C-arm movement. b. The display should include C-arm position in all axes, table height, and the side of the imaging system and required table side controls, touch screen for table side operations. c. All movements of the gantries should be controlled by the joystick / switch buttons on the table side as well as from the console room. d. The system should have adequate collision protection for the safety of the patient. e. Both gantries should have fast speed for angulations and positioning. Specify the rotation speed of the frontal plane in degree/sec. For all positions and lateral plane should have a speed of at least 8 degree/sec. f. Gantry angulations in both planes frontal and lateral should be freely user selectable to satisfy clinical imaging needs. The LAO/RAO range shall be at least ±90 degrees or above and CRA/CAU shall be at least ± 45 degrees or above. g. Both the gantries should have an automatic positioning storage and recall capability dependent on the reference image being selected and possibility to select reference image depending on the gantry position. It should have auto stops in isocenter in various positions like park position, Neuro, cardiac or peripheral positions. Positions that can be called: Frontal, lateral, SID, shutters, wedges, magnification. h. It should be possible to pre-program the gantries for multiple examination positions. Please mention the number of customized pre-programmes that can be configured. 3 Patient Table: (with table accessories) a. The table should have motorized / Floating longitudinal and horizontal and motorized vertical travel. The table should have motorized longitudinal movement b. The table should be contoured for all neuro interventional procedures i.e. head cage / head rest c. It should have full range of applications without restriction on position during CPR. d. If the facility has automatic bolus chase for peripheral angiography. Please mention e. The table is preferred to have a Trendelenburg tilt and side to side tilt facility, as an optionIt should be possible to lock the table in any position f. It should be possible to swivel the table (specify degrees) g. The tabletop shall have length of 300 cm, width 45 cm h. The table should support weight of minimum 150 kg excluding accessories. i. Patient stabilizing or fixing accessories should be provided specially for unconscious and agitated patients j. System should have foot switch (preferably wireless) for releasing fluoroscopy, acquisition and table breaks. k. Table side control for 3D acquisition and display of processed 3D images back to the examination room. l. The longitudinal movement of the tabletop shall be at least 100 cm and the transverse movement shall be not less than 15 cm. m. Table height shall be electrically adjusted in the range of 75 cm to 100cm above floor level 4 X-Ray Generator : a. Advanced technology generator should be provided having multi-pulse/high frequency for constant output. Delay time between lateral and frontal plane x-ray exposure when they work simultaneously should be mentioned. b. Waveform of the ramp-up,down to be specified be described. c. Output should be 100 KW or more. d. Radiography KVP range should be in the range of 40 KV – 125 KV or more. e. Fluoroscopy mode range 60 - 120 KVp f. Output at 100 KV should be 1000 MA or more. g. It should have automatic exposure control device for radiographic fluoroscopy and angiography mode. h. It should have digital display of kVP&mAs. i. Anatomical programming radiography should be possible. j. It should have over loading protection. k. It should have the facility for pulsed fluoroscopy at variable rates for reducing the x-ray dose to the patient during intervention procedure. Digital pulsed fluoroscopy at variable pulse frequencies (1 to 30f/s) shall be made available 5 X-Ray Tubes: a. Both planes should be provided with rotating anode high speed tubes and should have minimum two focal spots. It should allow for high power of heat dissipation and should provide 80 KW output in any one of the planes. b. Tube should be having a latest available technology for cutting the unnecessary radiation to patient, operator and staff, please specify the same. Secondary grid switch to be provided as standard. A. The focal spots should have at least the following sizes and specifications. B. Small focal spot -size 0.5mm or less; at least 15kw C. Large focal spot -1.0 mm or less;at least 65kw for extended runs D. Effective / Actual Anode heat storage capacity should be equal or more than 3.3 MHUandhaving liquid bearing technology or metal lubricant or specify the alternative cooling method available. E. The system should have adequate cooling facility for the x-ray tubes for uninterrupted performance during procedure for at least 6 hours continuously. F. Specify the technology available for radiation exposure reduction G. Anode heat cooling rate should be specified in W/min Leakage radiation shall conform to international standards. Filtration and leakage radiationdose shall be indicated in the bid. 6 Collimator: a. Atleast One collimator for each plane is to be provided. b. The collimator should have facility for automatic copper pre-filtration for reducing the x-ray dose. c. The collimator leaf should have IRIS / rectangular type arrangement. d. The collimator should have the facility for the dose measurement chamber to display the skin dose on the monitors in the lab. e. The system should have positioning of collimator blades without radiation. f. It should be possible to create, print and exported to PACS the DICOM based dose report of the patient. g. The system must have latest software / hardware packages for radiation safety of operator and patient. 7 Flat Panel Detector a. Dynamic flat detector system with high spatial resolution and minimum of14 bit contrast resolution. b. Specify the Detective Quantum Efficiency in both the planes c. Size of the frontal plane detector should be 45 cms diagonally and minimum 39cms diagonally in the lateral planes. d. It should provide multiple formats/fields withmultiple possible sizes with minimum of five formats. e. Specify the Spatial resolution in Lp/millimeter for both the planes. f. Both frontal and lateral plane flat detectors should have comparable panel size, fields of view, spatial resolution, detector pixel size. Both frontal and lateral plane flat detectors. should have comparable panel size (size of the detectors as mentioned in the point 7C), fields of view, spatial resolution, detector pixel. g. Detector pixels shall be not more than 200 microns for the frontal and lateral planes.. h. Specify the Image matrix in both the planes. i. Image viewing system/viewing/control consoles. 8 MONITORS in suite a. State of the art Medical grade monitor of Minimum of 50” inch size display for simultaneous viewing of minimum 6 images (at least live, reference, 3D rotational angio and unsubtracted image) should be provided. b. Two 19 inch medical grade LCD/TFT monitors should also be provided in the examination room with facilities to display line /reference/ 3DRA image as and when required for back up purpose (parallel to examination room display). 9 Monitor in CONSOLE ROOM a. 19 inch medical grade LCD/TFT monitors should also be provided in the console room with facilities to display line /reference/ 3DRA image for both planes (4number) b. Console Monitor for patient registration. c. Monitor for patient physiological parameters d. For each monitors following specifications should be mentioned - Display technology type (LCD, LED,IPSetc), Length, breadth and diagonal size of the viewing area, display format (4x3 or 16:9 or 16:10), native resolution, refresh rate, total megapixel, viewing angle, brightness in Cd/m2, Contrast ratio, Ingress Protection standard. e. Optional – facility for remote viewing of live images. 10 Physiological monitor in examination with the requisite computer system for BP, Pulse, Temp., Respiratory rate, NIBP, IBP, SpO2 measurement, display and analysis. 11 Digital Imaging System and essential softwares: a. The system should have latest image processing software to have excellent quality at lower dose. b. Road mapping facility (Real time 3D/4D/blank road map) should be available with possibility of superimposing of fluoroscopy image on reference image. Facilities for unlimited subtracted high resolution fluoroscopy should be available. c. Automatic pixel shifting facility during road mapping be made available. d. Facility to display subtracted and native images simultaneously alongside the reference image in the examination room e. Last image hold or reference image toggling with fluoroscopy should be available. f. Saving and capture of last fluoro image. g. Bolus chase software if available should be provided. h. Facility to use the reference image as a roadmap by super imposing of fluoro image on the reference image shall also be provided. i. DICOM compatibility and PACS connectivity shall exist. Transferring capability of all the patient images on a CD/ DVD/USB shall be provided. j. It should have the capability to acquire and post process images in 2K matrix at least in one plane with a speed of 6 frames or more per second on-line subtraction (please specify). k. Incorporation of Artificial Intelligence powered enhancement is desirable. l. Storage capacity of 1,00,000 images in 1024 x 1024 matrixes. m. Post processing software facilities with real time edge enhancement, positive/negative image display windowing, electronic shuttering, roaming, image reversal, zooming and magnifying with text and annotation junctions should be available both on main console and work station. n. Motion Freeze equivalent to improve scan quality by correcting respiratory movements. o. Digital subtraction angiography software of automatic pixel shift enhancement for iodine contrast should be possible. 12 3D Rotational Angiography a. 3D Rotational data acquisition with an output of cross sectional CT like images (FDCT / CBCT). Multiplanar reconstruction possibility and VRT type images should be possible. These CT like images should be available in control room as well as examination room monitors. b. Live 3D-roadmapping should allow overlay of real-time 2D fluoro images, CT images (Acquired in Cath) on the 3D vessel image for live visualization of the guide wire, catheter and coils c. Roadmap Should be able to select the Procedures like Navigation, Coil, stent, Glue, Particle to visualize different materials. d. Acquisition Digital rotation angiography at a speed of minimum 30°/sec or more shall be available in 1k matrix or more e. Scheme for 3D RA to be specified- Thresholding vs Subtraction or other equivalent technology. f. Image reconstruction and rendering time delay after acquisition to be specified g. Facility for post processing of the images from the angiosuite should be available h. Save at least 5 preset working positions and autoalign the C arms should be possible in each patient. i. 3D Road-mapping where C arm movement and dynamic changes in the 3D RA change in position should be synchronous. 13 3D CT imaging a. High contrast 3D cone-beam CT imaging should be provided as standard b. Fully automated and state-of-the-art metal artifact correction of the highest capacity to be provided c. Cross modality data fusion, registration and overlay should be possible to integrate vessel information in surrounding soft tissue information d. Image reconstruction should be fast & automatic. Typical image reconstruction & display time to be specified. e. CT windowing option to visualize soft tissue shall be available (This should be possible from the data on the 3D RA also). The CT 3D volume should be viewable and should have capability of post processing (set slice thickness, distance & angle measurements etc.) in control room and examination room as well. f. Provision for FDCT / 2D-DSA perfusion studies software for brain and body (qualitative and quantitative analysis) g. Provision for FDCT / 2D-DSA perfusion studies software for brain and body (qualitative or quantitative analysis or equivalent technology). h. It should be possible to have CT like imaging with collateral filling to see the lesion with ischemic stroke patients for immediate care with intra-venous injections. i. CT images for visualization of device/stent and flow diverters and for feeder vessels in area of tumor j. Possibility of aneurysm flow studies with quantitative or qualitative abilities or 4DRA AVM applications or equivalent technology. k. Feasibility of needle guidance procedures with laser guidance and detector support for the procedures like guided biopsies and vertebroplasties. 14 Image storage and archival a. It should have minimum image storage capacity of 1,00,000 images in the 1024 x 1024/10 bit. (please specify the maximum storage capacity available with the system with minimum image quality of 1024 x 1024 / 10 bit resolution). b. Direct digital archival on compact disk (CD _ DVD-recordable) in latest DICOM format. c. The system should be fully DICOM ready and fully compliant for connection to PACS system. d. A network attached storage (NAS) device with 100 TB storage connected with imaging and PACS system for data retrieval and storage It should be possible to pull back the data from server to main machine / workstation / console whenever required for viewing, post processing, reconstructions, and quantitative analysis. Storage server should be IHE compliant. 15 Workstation a. Post processing software facilities with real time edge enhancement, re-masking, peak opacification, image inversion, anatomical background display, windowing, electronic shuttering, roaming, zooming and magnifying with text and annotation functions should be provided. All essential post-processing functions should be possible from tableside consoles and from the control room. b. All options related to 3D (MIP, SSD, VRT, slicing, measurement tool, volumetry etc.) shall be available. c. Assisting software for planning and guiding tool for AVM, aneurysm flow diversion, stenting or similar to be quoted d. The system should be provided with image fusion software and shall have facility to import images of CT or MRI data for 3D fusion with automatic alignment of two data sets based on similar structures in the data sets, landmark based registration with convenient landmark editor for point-based registration using anatomical landmarks. It should be possible for side by side visualization of both data sets with correlated pointer and 2D alpha-blending in monochrome or pseudo- colour with adjustable balance between the two superimposed data sets. e. Dedicated protocols for visualization of stents/ flow divertors /intra saccular devices f. Software for advanced automated vascular analysis and quantification including stenosis quantification, virtual stenting, aneurysm analysis and catheter tip shaping with auto-calibration. g. Live and integrated needle guidance for interventional procedures such as vessel puncture, vertebroplasty, kyphoplasty, biopsies, drainages, or radiofrequency ablations etc. h. Independent connectivity to the PACS. i. Vendor neutral ability to view DICOM images of other modalities and vendors with basic image operations. j. A dedicated workstation for 3D reconstruction shall be provided with at least 128GB main memory for 3D reconstruction while allowing the main system for continuation of intervention procedure after 3D acquisition. k. The complete digital system along with workstation should be networked and connected to a DICOM compatible laser camera. Provision should be made for the live display of the monitors to the remote location especially during workshops. 16 Essential accessories: The following essential accessories to be provided with the unit:- On line UPS for the complete system, accessories including both tubes to enable acquisition for both planes with 30 min. back up at full load. One pressure injector of reputed make along with 100 disposable syringes sets (Medrad) Ceiling suspended radiation protection system and table side protection system. Focused ceiling mounted light with a handle for positioning the light. Ultra light-weight lead gowns as per the following specifications: 10 Nos. - Complete front & back protection, flexible insert with Velcro closure and built in shoulder relief pads. - Wall & stand hangers. It should have lead equivalent of 0.5 mm. It should be double sided type lead apron. (10 skirt and jacket type). It should be light in weight. Thyroid Guard in– 10 Nos &Gonadal shield- 6 (3 for adults & 3 for children) Lead spectacles – 05 Nos. Lead protected viewing glass (Size: 200cm X 100cm). Head support -2 Neuro mattresses – 1 Set of arm supports with adjustable cath arm support.- 4 Multiarmed drip stand mounted and adjustable on the table - 4 Patient straps.-4 Infusion pumps – 2 17. Portable / integrated vascular ultrasound unit a. The unit should be state of the art latest digital colour Doppler for abdominal, transcranial, vascular, applications and should be US FDA or European CE or BIS certified. b. Monitor Display screen should be flicker free and at least 14” in size with high resolution color LCD/LED. c. The system should process a dynamic range of at least 170 db. d. The scanning depth should be 30 cms or more. e. Imaging Modes: 2D, M-Mode, pulse wave Doppler, continuous wave Doppler, colour flow imaging, power Doppler. f. Tissue harmonic imaging should be available on at least one probe and system should have both online as well as off line zoom facility. g. For pulsed Doppler imaging, the machine should have provision for automatic real time calculations and display of at least six user selectable parameters like peak systolic velocity, end diastolic velocity, mean diastolic velocity, time average mean velocity, volume flow measurements, pulsatility index, resistive index etc. h. System should be small, compact, laptop size, ultraportable unit. i. It should have USB ports – slots for direct transfer of images to PC. j. Battery back-up of atleast 60 minutes for portable ultrasound unit. k. Indigenous trolley with mobile cart-light weight should be provided with slots for transducer and jelly bottle holder. l. Price of each probe should be quoted separately also. m. Should operate on 220 V 50Hz AC. n. The unit should have the following probes for each machine(price of each probe should be quoted separately): 1. Convex probe 2-6MHz(+ 1 MHz). 2. Linear array probe 5-11 MHz (+ 2 MHz). 3. TCD probe - 1-5MHz o. System should be capable of attaching 2 Probes at a time. It should support switching among 2 p. transducers at the touch of button on main keyboard. 18 WARRANTY a. The whole equipment including X-Ray tubeswith all accessories (such as portable ultrasound including probes, UPS, AC, pressure injector, and all third party items etc) supplied with the unit should have warranty for a period of 3 years from the date of handing over the fully functional unit. The vendor should take care of day to day running of UPS, AC etc. b. POST WARRANTY COMPREHENSIVE MAINTENANCE CONTRACT (CMC) FOR NEXT 7 YEARS c. The CMC should include whole equipment with all accessories supplied with the unit including X ray tube + labour + spares (portable ultrasound including probes, UPS, AC, pressure injector, and all third party items etc) and maintenance for another 7 yrs. d. The future software updates should be provided in the offered machine, as and when launched by the company without any additional cost for a period of 10 years(during warranty & CMC) after handing over of the system. 19 PENALTY CLAUSE: As per DME, Bengaluru Norms. 20 SPECIAL TERMS AND CONDITIONS a. Point wise technical compliance report supported by the technical catalogue/ specifications must be submitted in all truthfulness and shall be essence of the technical bid. b. The technical queries will only be entertained before the last date of prebid. The company has to give an undertaking for the same. c. The vendors have to provide the list of installation of the quoted / near similar models of d. machines installed in India /Abroad. e. The vendors have to provide the location of the nearest service center to ensure prompt repair / maintenance of the machine. f. Vendors are expected to visit the department of Radiology, KIMS, HUBLI and take inputs regarding the site of installation and other details after discussing with Department of Radiology, Engineering Section, KIMS, HUBLI. 21 Certifications a. The quoted model should be AERB approved. In case of first installation of quoted model in India, NOC from AERB for import must be submitted and the balance payment will only be released after AERB type approval of the quoted model is provided by the vendor. The offered unit and its installation must confirm to AERB guidelines and certification from AERB should be provided by the supplier. b. Offered model should be US FDA or European CE or BIS approved. Copy of certifications should be submitted with bid. c. In case of any safety modification/ recall , by any authority, Company should undertake to provide the same update,without any additional cost, in line with international installed base of the unit. 22 Training: On-site training of all faculty members & radiographers by application specialist for 4 weeks at time of installation. Requirements of Department of Anaesthesia for DSA facility: a. Air pipe line for both DSA 1 and 2. b. UPS backup for Anaesthesia equipment- workstation, monitor etc 23 Specification for Advanced Multipara-monitor 1) Monitor should have capability to display standard 8 waveforms and upgradable to upto 14 Waveforms and upto 22 parameter numerics box on single display. 2) A separated slave secondary display monitor similar to primary monitor, able to support configuration of the parameter settings. 3) Dedicated software and parameters to monitor physiological parameters of patient’s in DSA. 4) Capability to connect Keyboard, Mouse, Remote Control, Touchscreen 5) Each monitor should have Standard parameters: 3/5/12 Ld ECG, 3 Leads Resp, 2 Temp, 2 Invasive Pressures, NIBP, SpO2, EtCO2, monitoring levels of anaesthetic gases. 6) Specific Parameters required on the same monitor: AoA (Adequacy of Anaesthesia) & Neuromuscular Transmission (NMT), Spirometry, 4 channel EEG, 4 Invasive Pressure monitoring. 7) Minimum 19 inch Medical Grade High Resolution TFT LCD with Touch screen on primary display. 8) Preferably combination of single control knob & active hot keys. 9) Should be able to perform Multi-lead (upto 4) arrhythmia analysis at the bedside 10) Shall be able to perform (automatic and manual) & display True diagnostic quality 12 lead. 11) ECG analysis at the bedside with complete measurement and interpretation. 12) Shall be able to perform/ review continuous on-line ST analysis upto 12 leads 13) Should have capability to perform realtime QT Analysis at the bedside. 14) Should be able to store 100 snapshots at bedside and upto 6 waveforms, 72hr Trend @ 20 sec resolution. 15) Should be able to detect and review Lethal Arrhythmias as well as other ventricular and Atrial Fibrillation as standard. 16) Shall be able to measure and display SpO2 - Low Perfusion, Motion Tolerant Spo2 technology. 17) Shall have colour coding for different pressure waveforms. 18) Should be able to perform manual and Automatic Non invasive Blood Pressure measurements 19) Should be able to set alarm limits for all the measured Parameters using single function 20) Should have Audio and Visual alarms with alarm light on display. 21) Should be able to use on Adult, Paediatric and Neonates. Software should be provided standard for all the monitors 22) The monitor should be equipped with support for local area network 23) Facility to integrate into the available anaesthesia information network/ electronic medical record. 24) Able be view other patients on the network from the bedside without the need of a central station. 25) Acquisition device should have the capability to rezero the pressure transducers without the need to go the bedside. 26) Acquisition device should have the defib/IABP sync port Acquistion standard 27) Shall have capability to superimpose baseline and current ECG complexes 28) Should have ability to save/restore configurations over network 29) Should have the capability to remotely service the monitor in the event of breakdown 30) Should have Systolic Pressure Variation (SPV) and Pulse Pressure Variation (PPV) monitoring capability which helps clinician in guiding fluid management 31) Should be European CE & US FDA certificated 32) Should have all electrical wires, sockets etc required for function of monitor 33) Each monitor should have a) Anaesthetic agent & Gas monitoring b) ECG, NIBP, IBP (2), SpO2, Temperature (2) 34) Capable of monitoring other parameters 35) WARRANTY---1 YEAR with 9 years CMC after warranty Spares required for each unit: a) COMPATIBLE Temperature probes for adult 3 NOS, paediatric 3 NOS b) ECG cables with lead – 4 NOS c) PAEDIATRIC SPO2 PROBES-2 PROBES, ADULT SPO2 PROBES--8 PROBES d) SPO2 CABLES-5 NOS e) EXTRA LARGE ADULT BP CUFF – 4 NOs f) ADULT BP CUFF-(25-35 CMS)- 6 NOS g) CHILD BP CUFF (18-26CMS)- 4 NOS h) PAEDIATRIC BP CUFF- 2 nos i) Others required j) Compatible Entropy module 1 nos with 2cable (and 50 sensors) k) COMPATIBLE BIS module 1nos with 2cable (and 50 sensors) l) COMPATIBLE NEUROMUSCULAR MONITOR (NMT)---1NO; with cable m) Compatible EEG module 1NOS with 2cable and electrodes n) Desirable - capability of integrating with cerebral oximetry 24 L1 shall be decided based on 1. Cost of the equipment with equipment accessories with one year warranty. 2. CMC cost for next nine years.
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