FDA CE Portable Digital X-Ray Imaging System Mobile Machine Unit

Description

pasting
Dental Portable X Ray Machine LK-C27
Warning: After turning on the machine, wait for 1 minute, the vo
ltage can be stabilized before normal use；After each photo, you have to wait 30 seconds before you can take a normal photo。
Fetures:
1.This portable dental X-ray unit is high frequency machine.
2.The body is small, light weight and nearly no radiation.
3.It has excellent image quality, portable storage, save more space.
4.It uses high frequency and DC international power supply.
5.All of the components installed in the central PC board concentrated. Shock,set-up, electron tubes, all of them are insulation vacuum, sealed stereotype protection.
6.There are also manual buttons installed on the surface of shell, as well as batteries and charges7.This unit mainly suitable for oral pre-treatment for learning internal organizational structure, root depth and so on, is indispensable in daily life clinic equipment, especially for dental implant surgery.
8. It also can connect with sensor, is great convenience.
9.  The battery is durable, it can take about 5 hundred images after fully charged.
10. It can be connected with intra-oral digital X-ray imaging system.
Technical Parameter:
Tube voltage: 60KV
Tube current: 1mA
Exposure time: 0.1--2.0s
Frequency: 30KHz
Rate power: 60VA
Distance from skin to cone: 130mm
Tube focus: 0.3mm*0.3mm
Battery: DC14.8V  6400mAh
Charger input voltage: AC100V-240V±10%
Output voltage: DC16.8V
Ambient temperature: 5
℃
~40
℃
Relative temperature: <75%RH
Net weight: 2.5KG
Gross weight: 3.5KG
Size(mm): 138*165*185
Package size(mm): 220*240*275
Packing List:
Main body 1pc
Charger   1pc
User manual 1pc
User manual 1pc
_______________________________________________________________________
BLX-（5）8Plus
Product introduction:
This model combines the advantages of similar products found at home and abroad; it eliminates the shortcomings of the on-frequency X-ray machine (high current intensity and excess amounts of scrap x-rays).Using a Toshiba 0.3 micro-focus tube.The tube voltage frequency of this machine is 30 KHz，and the tube current is 1 MA. The radiation scope is at an angle of 24 degrees， located within a distance of 1.2 meters ahead. This is an innovative Chinese design named the "Green X-ray Machine."
Warning: After turning on the machine, wait for 1 minute, the vo
ltage can be stabilized before normal use；After each photo, you have to wait 30 seconds before you can take a normal photo。
TECHNICAL SPECIFICATIONS：
Tube Voltage
60kV
Tube Current
1mA
Time Exposure
1~~9s
High pressure generator
30kHz DC
Rated Power
60w
Focal Spot To Skin Distance
>20CM
Focus Spot Size
0.3mm(TOSHIBA)
Charger Input Voltage
AC110V～220V
Supply Frequency
50Hz±1%
Radiation Leakage
<20ugy/h
Battery
24V DC 8000MA
Weight
4.3KG
Dimensions
37 cm×31 cm×28cm (L×W×H)
Reference of the Angles ：
'
Tooth
Upper
Lower
1-2
42
-15
3
45
-18
4-5
30
-10
6-8
28
-5
Reference of the time of exposure：
Tooth
Adult
Child
Central & Lateral
0.8-1.2
0.8-1.0
Cuspid & 1st Bicuspid
1.2-1.4
1.0- 1.2
Upper 5，6
1.6-1.8
1.4-1.6
Upper 7，8
3.0-3.5
2.8-3.3.
Lower 5，6
1.8-2.0.
1.6-1.8
Lower 7，8
2.0-2.5
1.8-2.3
Packing List:
Main machine   1pcs
Power line      1pcs
User manual     1pcs
_________________________________________________________________________________
X-Ray
BLX-5
Features:
1.
)
The tube voltage frequency of this machine is 30 KHz, and the tube current is 0.2 MA. The radiation scope is at an angle of 24 degrees, located within a distance of 1.2 meters ahead.
2.
)
Toshiba 0.3mm x 0.3mm micro-focus tube
3.
)
No protective operation room is needed when installing the complete machine
4.
)
Flexible adjustment of position and angle of handpiece
5.
)
Compact in volume, light in weight, convenient for carrying
6.
)
Time is adjustable, high contrast of picture, imaging in focus
7.
)
There are vacuum components and high-pressure parts inside of the machine, so for your safety and the maintenance of the machine
8.
)
The tube head is equipped with excellent radiation-shield protection (except the radial mouth, and tests have shown that the radial index is zero. Safety is guaranteed.
9.
)
Non-film inspection and storage can be realized when corresponding to a sensor
Specifications
Voltage: 110v±10% and 220V±10%
Power: 24V 8000MA
Charger: 220V/110V, 50Hz
Tube current: 0.1mA
Rating: 60W
Frequency: 30 KHz
Exposure time: 1-9 seconds optional
Leak radiation: < 20μgy/h(12lb)
Focus Skin Distance: >20cm
Tube voltage: 60KV
Relative Humidity(RH) < 80%
Storage conditions: 5-40 degrees Celsius, relative Humidity
Net weight: 5.5 kg
Dimension: 47 x 42 x 19 cm
Content:
Main Unit x 1
Dental Film Position x 1
Charger x 1
English Manual x 1
Warranty Card x 1
Operation of the Main Unit
1. Upon receiving, open the box and check the product for possible damage during shipping.
2. Make sure the fittings on the encasement list are packaged within the box.
3. Connect the six-core cable (of the Main Unit) to the joint of the ball head and tighten the screw
4. After the Main Unit and ball head are perfectly fit together, plug in the international standard electrical source, grounding is strongly recommended.
5. Turn on the Power; the pilot lamp will be light up.During this time, the digital tube of the main unit will show the fore setting time. Now the equipment is in standby mode.
6. Setting the time (Skip to next step if unneeded) Use the "SET", "+", and" -" buttons to reset the time as follows: press SET, the pilot lamp above is illuminated, the machine is now in the time setting mode→then press "+" and" -" to set the time needed (time range is 0.5-9seconds); press set again when the time is adjusted the light lamp is off. The equipment is now in standby mode.
7. Put the Tooth film plumb behind the tooth which is going to be taken picture, and be as close as possible (the smooth side stick to the tooth)
8. Keep the ball head plumb to the tooth projection position; Have the ball head, tooth, and tooth film steadily mutually plumb.
9. After positioning, use theEXP on the main Unit, the remote controller, or the button on the touch head tube to take pictures. The three methods have the same effect. (Notice: gently press)
10. After exposure to the tube, release the start button again (available in three ways) in case of an emergency to stop shooting and return to standby status. (At this point there was no output ray, so the dental films can be used again).
Repeat step 6 to reset the picturing time.To repeat the picturing process, please repeat steps 7 to 9.
11. Turn the power of the main unit off when the work is finished, press POWER, making sure the pilot lamp is off. Don't keep the main unit long in standby mode.
Points for Attention
1.
Make sure the angle of film, tooth, and ball head are properly aligned when taking a picture. Keep them steady until the last step of picturing; making sure that there is no change in any of their positions.
2.
Remember to turn the power offwhen work is done.
3.
Change the battery if the remote controller loses its functioning or if the remote's distance is shorted.
4.
After turning the power on, wait one minute before taking pictures, this allows the ray to provide a steady output.
5.
The equipment switches into protection mode automatically when the voltage is incorrect. If this occurs,  it will not be able to carry out the normal work of filming.
6.
When taking pictures, the EXP button could stop the objection and then the machine goes back to the preparation mode.
7.
Use high quality tooth film and developing liquid to make clear pictures.
8. Handle the ball head gently while in use, so as not to damage the delicate component.
9.
Do not pull hard on the cable which connects the ball head to the main unit.
10.
The cable connecting the ball head to the main unit cannot bear the weight of the ball head, so do not raise the ball head by holding the cable, it will cause damage.
11.
We usually set the time between 3-8 seconds when taking pictures, but the actual time of ray output is 0.2-0.5 seconds.
12.
If a situation occurs,  preventing the machine from taking regular pictures,  contact the seller to solve the problem instead of trying to service the product yourself.
13.
Keep the tooth film and the liquid in a proper place and use them within the shelf-life period.
While, because the liquid is not allowed to ship by carrier normal, so we take it out before ship, look forward to your understanding.
14.
Development of films should be performed at temperatures ranging between 23-25 degrees Celsius to ensure the image quality.
15.
Other requests accordance with the scope of the technical parameters.
16.
Please read the manual carefully before using.
FDA Statement
The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, you can bid on this item only if you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item.
Seller name:dr.baistra
City,State:SHENZHEN,China
Telephone number:0755-32870423
On Nov-10-20 at 18:45:11 PST, seller added the following information:
On Nov-10-20 at 18:45:12 PST, seller added the following information:
Device Classification Name
System, X-Ray, Mobile
510(K) Number
K200976
Device Name
SR-8230, SR-8230S Portable X-Ray Unit
Regulation Number
892.172
Classification Product Code
IZL
Date Received
4/13/2020
Decision Date
6/10/2020
Decision
Substantially Equivalent (SESE)
Regulation Medical Specialty
Radiology
510k Review Panel
Radiology
Summary
Summary
Type
Traditional
Reviewed By Third Party
No
Combination Product
No