Two mobile x-ray machines

Опис на набавката

1 General characteristics
1.1 A system where all components are physically integrated with an S-arm, with a separate workstation
1.2 SID minimum 107 cm
1.3 Orbital rotation minimum 160 0
1.4 Angular rotation in the minimum range +/-210 0
1.5 Height adjustment up/down of the S-arm minimum 45cm, motorized
1.6 Horizontal displacement of only the S-bow front/back minimum 20 cm
1.7 The maximum time for fluoroscopic recording is not limited
1.8 Removing the grid for pediatric applications
1.9 Free space (distance) between the collimator and the detector at least 80 cm for correct positioning of the bow during orthopedic procedures
1.10 Leg pieces
1.11 Power supply: 220-230V, 50/60Hz
1.12 Automatic Dose Control
1.13 Device for measuring delivered dose (DAP meter), with minimum options:
1.13.1 Measurement of the patient's accumulated dose
1.13.2 Calculation of the accumulated rate of kerma
1.13.3 Air Kerma Rate Calculation
1.13.4 Recording of total fluoroscopy time
1.13.5 Accumulated dose in one study and in other previous studies of the same patient
1.14 User manual installed in the system and can be displayed on a monitor if necessary
2 Operator control panel
2.1 Panel in the form of a color touch-sensitive monitor
2.2 Minimum diagonal of the monitor 12.5"
2.3 Minimum resolution of the monitor 1920x1080 points
2.4 Monitor rotation in a minimum range of 270 0
2.5 Management of all system functions through the monitor
3 Generator
3.1 Maximum power should not be less than 5kW
3.2 The maximum voltage should not be less than 120kV
3.3 Maximum current during pulse fluoroscopy should not be less than 40mA
3.4 Maximum current during radiography should not be less than 100mA
4 X-ray tube
4.1 With rotating anode
4.2 Minimum 2 foci, small focus not larger than 0.3mm, large focus not larger than 0.6mm
4.3 Heat capacity of anode not less than 310 kHU
4.4 The maximum anode cooling should not be less than 60kHU/min
5 Collimator
5.1 Motorized filter drive
5.2 Minimum of 3 different filters
5.3 Laser and grating
5.4 Positioning laser from both sides, detector side and x-ray tube side
5.5 Grid made of aluminum or equivalent material with the same characteristics
5.6 Removal of the grid without the use of tools for pediatric procedures
6 Digital flat detector
6.1 Integrated into the S arch
6.2 Type of detector: Amorphous silicon or equivalent
6.3 Pixel size maximum 160 μm
6.4 A/D conversion minimum 16bit
6.5 Active area of ​​the detector minimum 207mm x 207mm
6.6 Resolution minimum 1340 x 1340 points
6.7 Maximum frame rate not less than 25 frames/second
7 Workstation
7.1 To have at least 2 monitors
7.2 Minimum diagonal of the monitor 21.5”, touch sensitive
7.3 Minimum resolution of the monitor 1920x1080 points
7.4 Monitor contrast minimum 5000:1
7.5 The total rotation of the monitor should not be less than 360 0
7.6 Adjusting the height of the monitor in a minimum range of 25cm
8 System acquisition and management
8.1 Easy patient registration in an emergency
8.2 Patient positioning instructions integrated into the system
8.3 Image processing that allows performing measurements, rotations, annotations, horizontal and vertical inversion, grayscale inversion, zooming, magnification, electronic collimation, printing
8.4 View images in full screen
8.5 Radiation dose control applied to a patient with
overdose warning
8.6 Tool to control the elimination or reduction of artifacts.
8.7 Tools to reduce image noise.
8.8 Image Optimization Control Tools
8.9 Last Image Retention
8.10 Minimum System Memory 500GB SSD
8.11 Modes of Acquisition
8.11.1 Pulsed fluoroscopy
8.11.2 Reduced-dose pulsed fluoroscopy
8.11.3 Pulsed DSA fluoroscopy
8.11.4 Reduced dose digital radiography

Опис на набавката

1 Provides complete protection around the entire body
2 Front side protection level equivalent to a minimum of 0.50mm lead
3 Backside protection level equivalent to a minimum of 0.25mm lead
4 Full front folding
5 Elastic belt across the waist to reduce the weight of the clothes on the shoulders
6 Adjusting the height of the elastic waist belt
7 Shoulder pads
8 Provides a reduction in radiation exposure from:
8.1 99% at X-ray tube voltage of 50KV or better
8.2 99% at X-ray tube voltage of 70KV or better
8.3 97% at X-ray tube voltage of 90KV or better
8.4 95% at X-ray tube voltage of 110KV or better
8.5 92% at X-ray tube voltage of 150KV or better
9 Drikers for fixing protection for thyroid and sternum
10 Shielding for thyroid and sternum, shielding equivalent to minimum 0.50mm lead, standard size, drickers for fixing protective apron
11 In accordance with the standards:
11.1 IEC 61331-1:2014 (Protective devices against diagnostic medical X-ray radiation - Part 1: Determination of attenuation properties of materials)
11.2 IEC 61331-3:2014 (Protective devices against diagnostic medical X-ray radiation - Part 3: Protective clothing, goggles and patient shields)
Sizes:
Set S size (100cm) for persons with a height of 160-170 cm – 1 piece
Set M size (110cm) for people with a height of 170-180 cm - 1 piece
Set L size (120cm) for people with a height of 175-190 cm - 3 pieces
Set XL size (130cm) for people with a height of 185-195 cm - 3 pieces

Опис на набавката

11 General characteristics
1.1 Digital mobile device on wheels intended for radiographic images
1.2 Rotating telescopic carrier of X-ray tube/monoblock
1.3 Rotation of telescopic carrier of X-ray tube minimum +/-90 degrees
1.4 Rotation of the monoblock around the transverse axis at least 150 degrees
1.5 Rotation of the monobloc around the sagittal axis minimum +/- 180 degrees
1.6 Maximum distance of the focus of the pipe to the floor minimum 2150 mm
1.7 Maximum height of the device during transport maximum 151 cm
1.8 Maximum width of the device 70 cm
1.9 Maximum length of the device during transport maximum 150 cm
1.10 Manual exposure switch
2 Generator
2.1 Maximum output power not less than 30kW
2.2 Frequency minimum 40 kHz
2.3 Thermal capacity of monobloc minimum 800kHU
2.4 Setting of kV in min. range from 40 – 125 kV in 1 kV steps
2.5 Exposure time in the minimum range of 0.001 - 2 seconds
3 Detector
3.1 A-si sensor or equivalent
3.2 Wireless data transfer to control panel
3.3 Spot size maximum 140 µm
3.4 Field size minimum 360x430cm
3.5 Size of active area minimum 358x430mm
3.6 Resolution of active area minimum 2560 x 3070 points
3.7 Depth of acquisition minimum 16 bit
3.8 Spatial resolution minimum 3.5 lp/mm
3.9 Operating time with two batteries minimum 15 hours
3.10 Degree of protection against ingress of dust and liquid at least IP67
3.11 Possibility of partial loading of at least 200 kg
3.12 Maximum load on the detector minimum 400kg
3.13 Weight with one battery maximum 3 kg
3.14 Battery charger and two batteries
4 X-ray tube
4.1 Tube with rotating anode
4.2 Anode rotation speed minimum 3000 revolutions
4.3 Minimum 2 focuses
4.4 Focus size minimum 0.6mm, maximum 1.3mm
4.5 Heat capacity of anode minimum 105 kHU
5 Collimator
5.1 Collimator with rotation min. +/- 120 degrees
5.2 Built-in LED lighting
5.3 Additional filtration with a minimum of three different filters, combin.
5.4 Rotation minimum +/-120 degrees
5.5 Meter for SID measurement
6 Acquisition and management system
6.1 Control panel with a minimum 19" touch-sensitive monitor
6.2 Adjusting the tilt of the monitor at least 40 degrees
6.3 Patient Registration and Data Administration System
6.4 Artifact minimization and image quality optimization
6.5 Automatic darkening of the area outside the diagnostic area
6.6 Removal of Sequential Patterns Caused by an Anti-Scatter Network
6.7 Adding data for measured distance and angles, markers, predefined text messages to an image
6.8 Two-dimensional image processing, both for frequency and density (or gray levels)

Список и краток опис на правилата и критериумите

In compliance with the Law on Medicines and Medical Devices, the economic operator shall present a valid Decision for registration in the Republic of North Macedonia's Register of Medical Devices as evidence that the offered medical device is registered there.
The Law on Medicines and Medical Devices requires the economic operator importing unregistered medical devices to submit a document allowing importation (approval for interventional importation) or a certificate issued by MALMED certifying that, should they be chosen in the procedure, they will be granted an import permit.

Список и краток опис на правилата и критериумите

- Document for registered activity as proof that it had been registered as a natural person or legal entity to perform the activity related to the subject of the contract for public procurement; or proof that it belongs to a suitable association pursuant to the regulations of the country where it has been registered.
– Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.