C ARM FLUOROSCOPE X RAY MACHINE

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Description

Standards

Conformity to CertificationsEuropean CE
Certification Number and DateIN18/05832 & 17/11/2018
Type test approval from AERB requiredYes
Type test certificate date and numberMH-26762-MF-XRE-001
Conformity to Safety StandardsIEC 60601-2-54 or BIS equivalent

Performance Parameters

PurposeC arms fluoroscopes are used in a variety of general surgical, cardiac, and neurological applications, including aneurysm repair, pacemaker implantation, hip replacement, fracture reduction, foreign-body location, needle biopsy, catheter placement, pain management, per-cutaneous lithotripsy, and brachytherapy
UMDNS Name and Code1. Fluoroscopic Units, Portable – 18-434 2. Radio graphic/Fluoroscopic Units, Mobile – 11-758 3. Radio graphic/Fluoroscopic Units, Extremity – 18-435
The System should be microprocessor controlled, compact and mobile offering excellent Image detailsYes
Type of Mechanical Motion of C ArmMotorized
Horizontal movement Of C Arm in mm240
Vertical Movement Of C Arm in mm450
Angulation Movement of C Arm in degrees± 120
Radius (Immersion Depth)of C arm in mm610
Source to Image Distance in mm900-950
Arc Orbital Movement of C ArmAt least +90° – 25°
Total width of C Arm in mm( Free space of C arm)850
Panning Movement of C Arm ( Swivel movement)±10º
Safety Feature available for C Arm Movementa. 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 khz20-30
Generator Power output in Kw2
Fluoroscopy Range in kvp40-110
Fluoroscopy mA range, maximum in mA0.2 to 7
Dual focus Rotating Anode X-Ray Tube of focal spot0.3mm² (small) & 0.6mm² (large)
Anode heat storage capacity with tolerance ±10%40KHU
Modes AvailableContinuous fluoro, Pulsed Fluoro, Radiographic Mode
Pulses per sec1 to 5
Mode selection for Kv and mAAutomatic
Type of Image Intensifier9 ” Dual Field
Number of Monitors provided on intensifier system2 (One for LIH and one for memory display )
Type of monitor to be provided with intensifier systemLCD
Size of Monitors in inch17-20
Type of Collimator controlledFixed Collimation Slot
Type of CameraCCD Camera
Camera Resolution in pixels1K x 1K
Acquisition of Camera10 bits
Contrast ratio of intensifier unit10:1 to 30:1
Image storage capacity in images20000 to 50000
Image reversalYes
Zoom function available2x
Monitor with trolleyYes
Sterile covers for C-Arm/X-Ray tube/ Image IntensifierYes
DICOM CompatibilityYes
The system should be ready to connect with HIS/ PACSYes
Data transferCD/DVD
Lead Aprons – Full body and Skirt type(0.5pb) 4 number each
No of Thyroid shield and Gonald Shield4 number each
Radiation/Fuoro Exposure delivery SwitchHand Switch and Foot Switch
Display of mA, KV and other safety features on C – arm ConsoleYes
Radiography through Cassette with holderYes
Size of Cassette holder provided (for radiographic mode) in inch x inch14 x 17
Patient demographic detail entry facilityYes
Upgradable option to digital substration of angigraphy and peripheral angiographyYes
“Automatic image parameter selection with capability of switching on to manual selection”Yes
Operating temperature & humidity0 to 25 deg C and relative humidity of 15-90%
Type of Power SupplySingle phase, 220- 240 Vac, 50Hz-16 Amps Socket
UPS AvailabilityBuilt in
UPS backup time in minutes15
Servo Stabilizer suppliedYes
Rating of Servo Stabilizer5 KVA
User/Technical/Maintenance manuals to be supplied in English in hard and soft copyYes
Installation, Demonstration and training to be provided at consignee endYes
The Principal Manufacturer Must Have Direct Presence/approved service center In IndiaYes
Warranty in Years5
QA, QC and other tests as per NABH shall be carried out by OEM or authorized agency of OEMYes

Reports

Confirmity to Manufacturing StandardsISO 13485
Certification number and dateIN18/05832 & 17/11/2018
Copies of all calibration and test reports and certifications to be submitted at the time of Supply of MachineYes

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