Description
“Standards
Conformity to Certification CDSCO/AERB
Certification number and date ICMED/000013 dated 17/10/2018
Type test approval from AREB required Yes
AREB approval certificate number of Particular Model 18-TA-264248 dated 14/03/2018
Confirmity to manufacturing standards Both ISO 13485 and ICMED 13485
Conformity to safety standards IEC 60601-2-54 or BIS equivalents
Performance Parameters
Purpose For Radiography examination
Type of Frequency generator High frequency generator
Frequency generator output in kW 82
KVP range in KV 40 -150
Current output 800 mA or more at 100 kV
Provision of Anatomical programming radiography Yes
Over loading protection Yes
X-ray tube positioning Floor Mount Tube stand
X ray tube should be high speed rotating anode and must have dual focus Yes
Tube rotation in degree 120
Size of large focal spot in mm Upto 1.5 mm
Size of small focal spot in mm Upto 0.1 mm
Anode Rotation Speed (minimal) per minute 2800
Permanent Filtration 0.9 mm Al / 75 kV
Anode heat storage capacity (min) 300 kHU or more
Heat dissipation rate 670
Automatic exposure control device provided Yes
Maximum Exposure time in milli second 4 to 6
Digital display for KVP & mAs provided Yes
Range of tube movements in vertical planes in cm 150
Range of tube movements in longitudinal in cm 150
Range of tube movements in lateral planes in cm 150
Electromagnetic brakes with fully counter balanced mechanism for tube movement Yes
Facility to display tube angulation Yes
Centering devices to be provided Yes
Maximum source to image distance (SID) in vertical position 150
Maximum source to image distance (SID) in horizontal position 100
Collimeter rotation in degree ?180
Multileaf collimator having halogen lamp/bright light source, with auto shut off provision of the light, should be available Yes
Minimum intensity of light field lamp ?150 lux
Full coverage size at a 100 cm SID(collimeter size) with ? 5 percent tolerances 430 x 430
Type of table provided Floating table top
Table top material with low attenuation and scratch resistant surface Melamine
Table Length in mm with ? 1 percent tolerances 2200
Table Width in mm with ? 1 percent tolerances 800
Table Height in mm with ? 1 percent tolerances 760
System should have longitudinal and horizontal table top movements Yes
Table should have provision for lateral imaging, without patient movement No
Range of movements for the table Transverse movements of + 10cm or more & Longitudinal movements+ 40 cm with electromagnetic brakes
Facilities of height adjustments No
Maximum Patient weight supported by table in kg 300
Foot switches for adjusting longitudinal/side to side movements, locking, and light adjustment Yes
Movable Grid with grid ratio 10:1 or more
Anti-collision and safety devices provided No
Counterbalanced, adjustable height, wall and floor mounted, vertical Bucky Yes
SID range of radiographic application including chest radiography in mm 1000 to 1800
Provision of doing chest radiography without grid Yes
Power supply Three Phase AC ( 380-440 V,50/60 Hz)
Thyroid shields supplied 4
Gonad sheet Male supplied 2
Gonad sheet Female supplied 2
Wall mounted stand for radiation protection aprons supplied Yes
Lead glass window Supplied Yes
Footsteps for the table supplied Yes
Lateral cassette holder provided No
Number of installations of the X- ray machines in Central /State/PSU Govt Hospitals (Hint: Seller should furnish a performance certificate of the device to the buyer incase demanded after placement of order) 0
OEM and Re-seller (if supplier is re-seller shall ensure uninterrupted availability of all spares for 10 years) Yes
Availabilty of toll free facility for technical support maintened by OEM or authorized agencies Yes
Demonstration of equipment and training to be provided after completing supplies before acceptance Yes
User/Technical/Maintenance manuals to be supplied in English in hard and soft copy Yes
Comprehensive Warranty in years 5
Additional Parameters
Patient fixing belts and compression device (for performing excretory urography, etc) Yes
Voltage stabilizer servo controlled in kVA 85
Lead lining for doors Yes
Light weight ?zero lead? radiation protection aprons provided Yes
Lead Aprons – Full body and Skirt type (each) 2 each (0.5pb)
Reports
The Principal Manufacturer must have direct Presence/approved service center In India Yes
Copies of reports and certifications to be furnished to buyer on demand at time of supplies Yes
QA, QC and other tests as per NABH shall be carried out by OEM or authorized agency of OEM Yes
Copies of all calibration and test reports to be submitted at the time of Supply of Machine Yes”
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