Search Results
Found 1 results
510(k) Data Aggregation
(219 days)
The Geelin500A/Geelin500M is a mobile digital X-ray C-Arm diagnostic system, which Is Intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The Geelin500A/Geelin500M permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.
The Dual-Mode Mobile C-Arm is divided into two models: Geelin500A and Geelin500M.
Both models comprise:
- X-ray generator (consisting of monoblock head, inverter, and collimator)
- X-ray imaging device (including digital image detector, image display, Touch Screen, and industrial computer)
- C-Arm retractable rack
- Accessories (consist of battery, movement control handle, exposure footswitch, and laser)
- Software: Digital image processing software CMXPS-500, software release version V1.0.0.
Differences between Geelin500A and Geelin500M:
- Base plate: The chassis of the Geelin500M is equipped with swivel casters and requires manual pushing to move the equipment. The chassis of the Geelin500A is equipped with an electric motor, allowing movement of the equipment using the movement control handle.
- SID (Source-to-Image Distance): Geelin500A has a variable SID (range: 0-250mm). Geelin500M has an invariable SID.
- Distance from the X-ray tube focus to the image intensifier (lateral view): The C-arm of Geelin500A is equipped with a retractable digital image detector mechanism, allowing for a variable SID from the tube focus to the detector plane (AP/LAT 1050 mm, variable (range 0-250mm)). For Geelin500M, SID is AP 1050mm /LAT 1200mm, invariable.
The Dual-Mode Mobile C-Arm is an X-ray device with dual-plane (A-vertical direction and B-horizontal direction) imaging function. Its main components are configured as follows:
- Two E-40R HF/IMD XR05 combined X-ray generators (40kHz, using rotating anode X-ray tubes, suitable for fluoroscopy and digital radiography) produced by IMD CHINA CO.,LTD. Small focus: 0.3mm, nominal anode input power: 0.6kW; Large focus: 0.6mm, nominal anode input power: 5kW.
- Two E-9040-5HF inverters produced by IMD CHINA CO.,LTD.
- Two PaxScan2121DXV flat panel detectors produced by Varian Medical Systems.
- The C-arm installs the two sets of X-ray systems on a 3/4 circular arc arm on the mechanical structure, and the ray directions of the two sets of systems are perpendicular to each other, showing an orthogonal relationship.
- The ray control system of C-arm is composed of single chip microcomputer and configuration touch screen. The signals from the combined X-ray generator and inverter are converted into signals that can be received and processed by the single chip microcomputer through the exposure control board. At the same time, the AD\DA module of the microcontroller provides filament preheating signals and kV setting signals for the ray generator and the inverter, and receives feedback signals from the inverter and the filament board.
- The exposure program is controlled by the relevant program in the microcontroller. After stepping on the foot brake exposure pedal, the foot brake signal will enter the single-chip microcomputer program, and the single-chip microcomputer will determine whether the ray system (flat panel detector state, inverter state and filament state, etc.) is abnormal (error or warning) in real time. Under the normal condition of the system and the inverter without abnormality, the single-chip microcomputer will continue to delay 0.8 seconds to give the exposure command signal to the inverter. After receiving the exposure command signal, the inverter immediately executes the exposure command and excites the X-ray generator to release X-rays. At the same time, the inverter will monitor the kV feedback signal in real time. When the feedback signal is abnormal or the inverter is abnormal, the inverter will immediately transmit the signal to the single chip microcomputer, and the relevant error information will be realized on the touch screen, and the exposure command will be immediately forced to end. The filament board will also monitor the filament status in real time. When the filament board is abnormal or the filament current preheating is abnormal, the filament board will immediately transmit the signal to the microcontroller, and the relevant error information will be realized on the touch screen, and the exposure will be forced to end immediately.
- The image generated by exposure is transmitted to the image processing workstation through the flat panel detector, and the workstation displays the image on the display screen after proper image processing.
N/A
Ask a specific question about this device
Page 1 of 1