C ARM FLUOROSCOPE X RAY MACHINE

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Description

Standards

Conformity to Certifications European CE
Certification Number and Date IN18/05832 & 17/11/2018
Type test approval from AERB required Yes
Type test certificate date and number MH-26762-MF-XRE-001
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, 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 Code 1. 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 details Yes
Type of Mechanical Motion of C Arm Motorized
Horizontal movement Of C Arm in mm 240
Vertical Movement Of C Arm in mm 450
Angulation Movement of C Arm in degrees ± 120
Radius (Immersion Depth)of C arm in mm 610
Source to Image Distance in mm 900-950
Arc Orbital Movement of C Arm At 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 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 20-30
Generator Power output in Kw 2
Fluoroscopy Range in kvp 40-110
Fluoroscopy mA range, maximum in mA 0.2 to 7
Dual focus Rotating Anode X-Ray Tube of focal spot 0.3mm² (small) & 0.6mm² (large)
Anode heat storage capacity with tolerance ±10% 40KHU
Modes Available Continuous fluoro, Pulsed Fluoro, Radiographic Mode
Pulses per sec 1 to 5
Mode selection for Kv and mA Automatic
Type of Image Intensifier 9 ” Dual Field
Number of Monitors provided on intensifier system 2 (One for LIH and one for memory display )
Type of monitor to be provided with intensifier system LCD
Size of Monitors in inch 17-20
Type of Collimator controlled Fixed Collimation Slot
Type of Camera CCD Camera
Camera Resolution in pixels 1K x 1K
Acquisition of Camera 10 bits
Contrast ratio of intensifier unit 10:1 to 30:1
Image storage capacity in images 20000 to 50000
Image reversal Yes
Zoom function available 2x
Monitor with trolley Yes
Sterile covers for C-Arm/X-Ray tube/ Image Intensifier Yes
DICOM Compatibility Yes
The system should be ready to connect with HIS/ PACS Yes
Data transfer 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, KV and other safety features on C – arm Console Yes
Radiography through Cassette with holder Yes
Size of Cassette holder provided (for radiographic mode) in inch x inch 14 x 17
Patient demographic detail entry facility Yes
Upgradable option to digital substration of angigraphy and peripheral angiography Yes
“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, 220- 240 Vac, 50Hz-16 Amps Socket
UPS Availability Built in
UPS backup time in minutes 15
Servo Stabilizer supplied Yes
Rating of Servo Stabilizer 5 KVA
User/Technical/Maintenance manuals to be supplied in English in hard and soft copy Yes
Installation, Demonstration 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, QC 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
Certification number and date IN18/05832 & 17/11/2018
Copies of all calibration and test reports and certifications to be submitted at the time of Supply of Machine Yes

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