Medical and technical requirements
Digital X-ray surgical apparatus of C-arc type (code according to EHS DK 021:2015 - 33110000-4 - Visualization equipment for the needs of medicine, dentistry, and veterinary medicine (code according to NK 024:2019 - 37646 General purpose mobile X-ray fluoroscopic system, digital))
№ з/п |
Name of the characteristic | Value or requirement for compliance with the characteristics |
1 |
General requirements |
|
1.1 |
The C-arm X-ray unit shall be digital | Conformity |
1.1 |
The mobile X-ray diagnostic fluoroscopic system of C-arm type shall be digital and intended for fluoroscopy and radiography | Conformity |
1.2 |
Main areas of clinical application: orthopedics, traumatology, general surgery, vascular surgery | Conformity |
2 |
Characteristics of the C-arch | |
2.1 |
C-arch depth not less than 700 mm | Conformity |
2.2 |
C-arch free zone not less than 800 mm | Conformity |
2.3 |
The range of orbital rotation of the C-arch is not less than 130° | Conformity |
2.4 |
The range of rotation of the C-arm in the horizontal plane is not less than ± 190° | Conformity |
2.5 |
The range of rotation of the C-arch relative to the vertical plane (left / right) is not less than ± 12 ° | Conformity |
2.6 |
The range of motorized vertical movement of the C-arm is not less than 400 mm | Conformity |
2.7 |
The range of horizontal movement of the C-arm is not less than 200 mm | Conformity |
2.8 |
Focal length not less than 1000 mm | Conformity |
2.9 |
Availability of wheels with brakes | Conformity |
2.10 |
Availability of laser localization device on the detector | Conformity |
3 |
Characteristics of the X-ray generator | |
3.1 |
The maximum frequency of the generator, not less than 44 kHz | Conformity |
3.2 |
The maximum power/voltage of the X-ray generator is not less than 2.3 kW | Conformity |
3.3 |
Modes of operation to be supported by the system: - pulsed fluoroscopy mode; - radiography or digital imaging mode (single digital exposure) |
Conformity |
3.4 |
The upper limit of the voltage range is not lower than 110 kV | Conformity |
3.5 |
The upper limit of the current range in the pulse fluoroscopy mode is not less than 24mA | Conformity |
3.6 |
The upper limit of the current range in the mode of radiography or digital image (single digital exposure) is not lower than 24mA | Conformity |
3.7 |
Frame rate not less than 30 frames per second | Conformity |
4 |
Characteristics of the X-ray tube | |
4.1 |
The maximum voltage on the tube is not less than 110 kV | Conformity |
4.2 |
Presence of at least 2 focal spots | Conformity |
4.3 |
The size of the large focal spot is not more than 1.0 mm | Conformity |
4.4 |
The size of the small focal spot is not more than 0.6 mm | Conformity |
4.5 |
The angle of inclination of the anode is not more than 12° | Conformity |
4.6 |
The heat capacity of the anode is not less than 75 kJ | Conformity |
4.7 |
Heat dissipation by the monoblock is not less than 4 500 TO/min | Conformity |
4.8 |
The physical heat capacity of the monoblock is not less than 800 kJ | Conformity |
4.9 |
Availability of a dosimeter with an ionization chamber (as part of a set/kit or integrated into the dosimeter software) | Conformity |
5 |
Digital flat panel detector | |
5.1 |
Availability of a digital flat panel detector | Conformity |
5.2 |
Matrix size not less than 1004x1004 | Conformity |
5.3 |
The maximum field size is not less than 200x200 mm | Conformity |
5.4 |
Pixel size not more than 210 microns | Conformity |
5.5 |
At least 3 formats of the working field | Conformity |
5.6 |
Availability of a protective radiation scattering grille | Conformity |
5.7 |
Digitization depth is not less than 16 bits | Conformity |
5.8 |
The determined quantum efficiency is not less than 80% | Conformity |
6 |
Characteristics of the image processing station | |
6.1 |
Ability to save images with a maximum resolution of at least 1024x1024 or 1Kx1K | Conformity |
6.2 |
The maximum volume of stored images is not less than 300,000 images | Conformity |
6.3 |
Brightness and contrast adjustment | Conformity |
6.4 |
Image inversion | Conformity |
6.5 |
Electronic image rotation | Conformity |
6.6 |
Ability to import images into the DICOM system | Conformity |
6.7 |
Monitor(s) on a cart or console with parameters: - Two monitors with at least 19 inches of diagonal - Viewing angle, not less than 178° - Resolution not less than 1280 x 1024 pixels - Maximum illumination 700 cd/cm2 |
Conformity |
7 |
Auxiliary equipment | |
7.1 |
Availability of an uninterruptible power supply to protect the digital C-arch system | Conformity |
(с) 2024