RequiredExperience with Government
RequiredAnnual Turnover
RequiredCertificate (Requested in ATC)
RequiredOEM Authorization Certificate Bid to RA enabled No C ARM FLUOROSCOPE X RAY MACHINE ( 1 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Standards Conformity to Certifications CDSCO/AERB European CE
RequiredUS FDA
RequiredCE European and US FDA
RequiredCDSCO/AERB Certification Number and Date - * Type test approval from AERB required Yes * 1/6 Type test certificate date and number - * Conformity to Safety Standards IEC 60601-2-54 or BIS equivalent * Performance Parameters Purpose C arms fluoroscopes are used in a variety of general surgical
Requiredcardiac
Requiredand neurological applications
Requiredincluding aneurysm repair
Requiredpacemaker implantation
Requiredhip replacement
Requiredfracture reduction
Requiredforeign-body location
Requiredneedle biopsy
Requiredcatheter placement
Requiredpain management
Requiredper- cutaneous lithotripsy
Requiredand brachytherapy * UMDNS Name and Code 1. Fluoroscopic Units
RequiredPortable - 18-434 2. Radio graphic/Fluoroscopic Units
RequiredMobile - 11-758 3. Radio graphic/Fluoroscopic Units
RequiredExtremity - 18-435 * The System should be microprocessor controlled
Requiredcompact and mobile offering excellent Image details Yes * Type of Mechanical Motion of C Arm Motorized Motorized
RequiredManual Horizontal movement Of C Arm in mm 200 * Vertical Movement Of C Arm in mm 450 * Angulation Movement of C Arm in degrees ± 180 ± 120
Required± 180
Required± 190
Required± 200 Radius (Immersion Depth)of C arm in mm 630 * Source to Image Distance in mm 950-1000 900-950
Required950-1000
Required1000-1050 Arc Orbital Movement of C Arm At least +90° - 30° At least +90° - 25°
RequiredAt least +90° - 30°
RequiredAt least +90° - 40°
RequiredAt least +90° - 50° 2/6 Total width of C Arm in mm( Free space of C arm) 761 * Panning Movement of C Arm ( Swivel movement) ±12.5º ±10º
Required±12º
Required±12.5º Safety Feature available for C Arm Movement a. Locks for all the movements. b. Control Stand foot lock. c. Steering wheel for easy steering & movement * Range of Frequency of X ray Generator in khz 31-40 20-30
Required31-40
Required41-50
Required51-60
Required61-80
Required81-90
Required91-100
RequiredMore than 100 Generator Power output in Kw 3.5 2
Required2.5
Required3.5
Required5
Required10 Fluoroscopy Range in kvp 40-110 40-110
Required40-120
Required40-130
Required40-100 Fluoroscopy mA range
Requiredmaximum in mA 0.2 to 7 0.2 to 7
Required0.2 to 13
Required0.2 to 17
Required0.2 to 20
Required0.2 to 30 Dual focus Rotating Anode X-Ray Tube of focal spot 0.6mm² (small) & 1.5mm² (large) 0.3mm² (small) & 0.6mm² (large)
Required0.6mm² (small) & 1mm² (large)
Required0.6mm² (small) & 1.5mm² (large) Anode heat storage capacity with tolerance ±10% 40KHU 40KHU
Required50 KHU
Required100 KHU
Required500 KHU Modes Available Continuous fluoro
RequiredPulsed Fluoro
RequiredRadiographic Mode * Pulses per sec 1 to 5 1 to 5
Required1 to 10
Required1 to 15
Required1 to 25
Required1 to 30 Mode selection for Kv and mA Automatic Automatic
RequiredManual Type of Image Intensifier 9 " triple Field 9 " Dual Field
Required9 " triple Field
Required12 " Triple Field Number of Monitors provided on intensifier system 2 (One for LIH and one for memory display ) 2 (One for LIH and one for memory display )
RequiredSingle monitor with dual image display
RequiredSingle monitor with dual image display touch screen Type of monitor to be provided with intensifier system LCD LCD
RequiredLED
RequiredTFT 3/6 Size of Monitors in inch 17-20 17-20
Required21-24
Required25-30
Required30-32 Type of Collimator controlled Both Fixed Collimation Slot & Motorized IRIS Fixed Collimation Slot
RequiredMotorized IRIS
RequiredBoth Fixed Collimation Slot & Motorized IRIS Type of Camera CMOS Camera CCD Camera
RequiredCMOS Camera Camera Resolution in pixels 1K x 1K 0.5K x 0.5K
Required1K x 1K
Required2K x 2K Acquisition of Camera 10 bits 10 bits
Required14 bits
Required16 bits Contrast ratio of intensifier unit 10:1 to 30:1 * Image storage capacity in images Above 100000 20000 to 50000
Required50000 to 100000
RequiredAbove 100000 Image reversal Yes * Zoom function available 3x 2x
Required3x
Required5x Monitor with trolley Yes * Sterile covers for C- Arm/X-Ray tube/Image Intensifier Yes * DICOM Compatibility Yes Yes
RequiredNo The system should be ready to connect with HIS/PACS Yes Yes
RequiredNo Data transfer Both USB and CD?DVD CD/DVD
RequiredUSB
RequiredBoth USB and CD?DVD Lead Aprons - Full body and Skirt type (0.5pb) 4 number each * No of Thyroid shield and Gonald Shield 4 number each * Radiation/Fuoro Exposure delivery Switch Hand Switch and Foot Switch * Display of mA
RequiredKV and other safety features on C - arm Console Yes * Radiography through Cassette with holder Yes Yes
RequiredNo Size of Cassette holder provided (for radiographic mode) in inch x inch 10 x 12 14 x 17
Required12 x 12
Required10 x 12
Required8 x 10
RequiredNot provided 4/6 Patient demographic detail entry facility Yes * Upgradable option to digital substration of angigraphy and peripheral angiography No Yes
RequiredNo "Automatic image parameter selection with capability of switching on to manual selection" Yes * Operating temperature & humidity 0 to 25 deg C and relative humidity of 15-90% * Type of Power Supply Single phase
Required220- 240 Vac
Required50Hz-16 Amps Socket * UPS Availability External Built in
RequiredExternal UPS backup time in minutes 15 15
Required30
Required45 Servo Stabilizer supplied Yes Yes
RequiredNo Rating of Servo Stabilizer 5 KVA 5 KVA
RequiredNot provided User/Technical/Mainten ance manuals to be supplied in English in hard and soft copy Yes * Installation
RequiredDemonstration and training to be provided at consignee end Yes * The Principal Manufacturer Must Have Direct Presence/approved service center In India Yes * Warranty in Years 5 * QA
RequiredQC and other tests as per NABH shall be carried out by OEM or authorized agency of OEM Yes * Reports Confirmity to Manufacturing Standards ISO 13485 ISO 13485
RequiredICMED 13485
RequiredBoth ISO and ICMED Certification number and date - * 5/6 Copies of all calibration and test reports and certifications to be submitted at the time of Supply of Machine Yes * * Bold specifications are the golden parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.
