Equipment Specifications for FLAT PANEL DIGITAL (Digital Cardiac Cath-Lab Single/Mono Plane with Intra Vascular Ultra Sound)

Transcription

1 Equipment Specifications for FLAT PANEL DIGITAL (Digital Cardiac Cath-Lab Single/Mono Plane with Intra Vascular Ultra Sound) UNSPSC Code: ECRI Code: 1. Description of Function 1.1 Cardiac Catheterization is required to do angiography of blocked vessels in the heart. Flat panel is the latest in digital X-Ray imaging technology. 2. Operational Requirements 2.1 Flat Panel Single Plane Cardiovascular Catheterization Laboratory system with Digital Subtraction Angiography With a Floor/Ceiling mounted arm stand and digital imaging X- Ray System for Cardiovascular Diagnostic and Interventional Procedures. 2.2 System should be complete with pressure injector, Homodynamic & Electrophysiological Study Recorder With Programmed Extra stimulus Stimulator and Radio-Frequency Ablation Generator and advanced integrated IVUS 3. Technical Specifications 3.1 GANTRY Floor/Ceiling Mounted Gantry rotation/angulations: LAO/RAO At least 100/100. Cranial/Caudal ± 45 degrees. Speed of Rotation: Cranial/Caudal: 10deg/sec or higher. LAO/RAO: 10 deg/sec or higher. Non-contact sensing mechanism. Real Time Patient sensing or Mechanical and Electromechanical covers with patient zone. Whole body head to toe coverage without repositioning patient. 3.2 Facility for rotational angiography 3.3 PATIENT SUPPORT TABLE Floating/Floor mounted with carbon fiber tabletop with easy patient transport capability 3.4 X-RAY GENERATOR should be of latest technology with high frequency type with at least 100 kw X-RAY TUBE Focus: Dual Anode Heat: 1.5 MHU or higher Capacity. Maximum heat dissipation capacity of at least 1500 Oiled or water-cooled to ensure continuous operation Latest generation tube, fluoroscopic power shall be at least 3000 watts for noiseless operation to support long-term interventional procedures & for better visibility in obese and deep angulations. 3.5 Image Acquisition System

2 1. Flat Detector of current generation, Good detector high spatial resolution acquisition and display in Matrix of at least 1024x Flat Panel detector system with excellent spatial and contrast resolution. 3. Frame rates selectable from 7-30 frames per seconds. 3.6 Monitors: TFT Monitors 18 inch or higher in exam room Additional monitor for patient database. CD workstation monitor Cath-Recorder Slave Monitor With high resolution matrix 1024 x 1024 Total at least 5 TFT Monitors 3.7 DIGITAL FLUOROSCOPY 8 Bit or higher. Flouro grab and replay facility 3.8 DIGITAL ACQUISITION & DIGITAL PROCESSING Acquisitions 1024 X 1024, True On Line Digital Subtraction Angiography: 1024x1024 with all post processing facility 3.9 Image processing system 1. Series exposures with frame rates of 30/15/10/7.5 fps 2. Pulsed fluoroscopy standard. 3. Applications for maximized radiation protection 4. DICOM 3 ready for patient data acquisition, documentation and archiving 3.10 COMMUNICATION AND ARCHIVING Review /Archiving & Networking. DICOM based CD recording for dynamic recording on CD. CDs to have DICOM software embedded for instant review in any PC. Ability to record DSA runs in CD. Standard line rate Video Output: Image storage capacity of at least 50,000 images at 1024x1024 matrix and Cath Lab should be supplied with state of the art QCA & LVA. Ability to generate single DVD incorporating multiple patient studies capable of review in any PC 3.11 Automated Motorized High Speed and Pressure Injection System HEMODYNAMIC AND ELECTROPHYSIOLOGIC STUDY RECORDER WITH PROGRAMMED EXTRA STIMULUS DELIVERING SYSTEM AND RADIO-FREQUENCY ABLATION GENERATOR Cardiac catheterization Electrophysiological & hemodynamic recorder with 4 invasive pressure recording. Simultaneously, 12 Lead ECG with two monitors in examination room and one monitor in Control room full remote operation. Full hemodynamic analysis and laser printer with full EP Recording and Analyzing System with Programmable Extra Stimulus Delivering Apparatus and Radio-Frequency Ablation System. Minimum 24 Intracardiac inputs 3.13 HEMOXIMETER Hemoximeter for measuring Hb and oxygen saturation during cardiac catheterization complete with all accessories like rinse solution, calibration solution etc for at least 1 year.

3 3.14 Latest generation integrated intra vascular ultrasound which is useable and interfacable with all IVUS catheters available in the market for coronary, peripheral and carotid IVUS studies with recording & DICOM facility and with at least 10 IVUS catheters provided free of cost and all controlling consoles of IVUS machine should be mounted on the Cath Table and also in the monitoring room. 4. System Configuration Accessories, spares and consumables 4.1 Main Unit C-Arm with Gantry, X-RAY generator and Tube and integrated Flat panel detector Automated Motorized High Speed Injection System Examination Light LEAD glass size- 200 X 100 cm 4.5 Digital Storage and Achieving system with DICOM CD RECORDER WITH 100 STARTER CDS Hemoximeter ACT machine and cartridges/tubes Flat Panel integrated. 4.9 Haemodynamic and Electrophysiologic Study Recorder with programmed extra stimulus delivering system and RF Ablation generator -01 set 4.10 Patient Table TFT Monitor Protective apron of at least 0.50 mm lead equivalent Protective gonad shield at least 0.35 mm lead equivalent Thyroid collars Lead Eye glasses Radiation protection device for the operator at the table and for legs below the table 4.17 Advanced two way communication system in cath lab and monitoring room

4 5 Environmental factors 5.1 The unit shall be capable of operating continuously in ambient temperature of 10 0 C C and relative humidity of 15-90% 5.2 The unit shall be capable of being stored continuously in ambient temperature of 0 50 deg C and relative humidity of 15-90% 5.3 Shall meet IEC : 2001(Or Equivalent BIS) General Requirements of Safety for Electromagnetic Compatibility The chosen supplier would be asked to undertake a turnkey Project wherein necessary civil work modifications like False Ceiling, Wall Tiling, Anti Static Flooring and finishing works would be provided by them under the supervision of the support staff e.g. CPWD (Civil). 2. The supplier would also provide the Scrub area and the Catheter wash area. 3. The supplier also would provide the necessary furniture like tables, computer chairs, cupboards, catheter hang wall mounts etc Appropriate Air-conditioning would be provided by the supplier and maintained throughout the Warranty period of the cath-lab. 2. The entire Cath-Lab including the Air Conditioning should be connected to the Generator of the hospital. 5.6 Proper shielding should have to be done by the supplier to minimize radiation leakage as per AERB and BARC regulations. 6 Power Supply 6.1 Power input to be VAC(Single Phase), / V (3 Phase)/ 50Hz as appropriate fitted with Indian plug 6.2 Reset table over current breaker shall be fitted for protection 6.3 Suitable Servo controlled Stabilizer/CVT for the entire cath lab. 6.4 Online UPS of suitable rating conforming to shall be supplied for the entire cath lab system including X-ray generation with a minimum power back up of 30 minutes. 6.5 The Power requirements involve laying a 125 KVA Cable from the substation to the Cath-Lab and making a Bus-Bar and a Power Distribution Board and this would be done by the supplier as a turn key project under the supervision of the support staffs e.g. PWD (Elect) 7 Standards, Safety and Training 7.1 Should be FDA or CE approved product 7.2 Electrical safety conforms to standards for electrical safety IEC General Requirements

5 7.3 Manufacturer should have ISO certification for quality standards. 7.4 Shall comply with AERB and BARC guidelines. 8 Documentation 8.1 User manual in English 8.2 Service manual in English 8.3 List of important spare parts and accessories with their part number and costing 8.4 Certificate of Calibration and inspection from the factory 8.5 Log book with instructions for daily, weekly, monthly and quarterly maintenance checklist. The job description of the hospital technician and company service engineer should be clearly spelt out. 8.6 List of Equipments available for providing calibration and routine maintenance support as per manufacturer documentation in service / technical manual. 8.7 User List and performance certificate of at least 5 cath labs installation in the past five years from government institutions should be submitted along with the techno commercial bid.