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AT - 301
Manual
Before attempting to connect or operate this product, please read these instructions completely!
Version：1.00
Contents
1. AT ECO AT-30 1 General Introduction..........................................................................................1
1.1 Functional Components........................................................................................................ 1
1.11 AT-301 sensor............................................................................................................... 1
1.12 Control Box.................................................................................................................2
1.2 Technic al Specifications........................................................................................................3
1.3 Sharing the Sensor Between Rooms..................................................................................... 3
1.4 Using the different Positioning Systems..............................................................................3
2. Imaging Software General Introduction........................................................................................ .4
2.1 Computer System Requirements...........................................................................................4
2.2 Imaging Software..................................................................................................................4
3. Driver Installation.......................................................................................................................... .5
4. Software Installation...................................................................................................................... .7
5. Register Key..................................................................................................................................11
6. Install Calibration File...................................................................................................................12
6.1 Install to Atecotech.........................................................................................................12
7. Software Operation......................................................................................................................13
8. Acquiring an Image.......................................................................................................................20
8.1 Preparing the AT- 301 sensor................................................................................................ 20
8.2 Preparing for Acquisition.................................................................................................... 20
8.3 Launching the X-Ray.......................................................................................................... 21
9.Ateco Image..................................................................................................................................22
10. Troubleshooting Images..............................................................................................................33
11 Maintenance................................................................................................................................. 36
11.1 Visual Inspection............................................................................................................... 36
11.2 Periodic Maintenance........................................................................................................36
11.3 Cable Care........................................................................................................................36
11.4 Damaged or Non-Functioning Sensor..............................................................................36
12. Warranty...................................................................................................................................... 37
13. Notice.......................................................................................................................................... 37
13.1 Indication of Use............................................................................................................... 37
13.2 Brief Introduction of this Manual..................................................................................... 37
13.3 Manufacturer..................................................................................................................... 37
13.4 Packinglist......................................................................................................................... 37
13.5 Symbols.............................................................................................................................38
14. Safety issue..................................................................................................................................39
14.1 Check Sensor and controller before using them...............................................................39
14.2 Protect Sensor from Potential ESD Damage.................................................................... 39
14.3 Do Not Touch Exposed Connectors on Non-Medical Equipment and the Patient at the
Same Time.................................................................................................................................39
14.4 Ensure Proper System and PC Workstation Installation and Operation...........................39
14.5 Safety Classifications........................................................................................................40
14.6 Conditions required in operation, transportation, and storage......................................... 40
14.6.1 Operating conditions..............................................................................................40
14.6.2 Transport and Storage conditions.......................................................................... 40
15. Was te Electrical and Electronic Equipment................................................................................41
15.1 Background....................................................................................................................... 41
15.2 WEEE Marking.................................................................................................................41
15.3 Reporting........................................................................................................................... 41
15.4 WEEE from Users other than Private Households........................................................... 42
15.5 Information for Reuse Centers, Treatment and Recycling Facilities............................... 42
15.6 Warning and Safety Instructions....................................................................................... 42
15.7 Hygiene and Disinfection Instruction............................................................................... 43
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1. ATECO AT-301 General Introduction
Dental digital x-ray imaging system is consisted of sensor, image controller, image
capture system and connection cable (USB port) , connected with PC or notebook via
USB cable. The power of controller and sensor is supplied by USB port, require no
battery or power charge system. The whole equipment need to work together with
imaging software.
1.1 Functional Components
1.11 AT-301 sensor
The sensor and control box is connected already, please check the light on control box,
before taking x-ray image. The power indicator on the control box displays yellow
light and working indicator flash green light.
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The sensor active surface is flat including the size 1 and size 2.
Size1, universal sensor---Use for regular procedures, both for children and adult .
Size2 sensor---Use for bitewings procedures.
The sensor non-reactive to X-Rays surface, contains the cable attachment.
Figure 2 AT-301Sensor
1 Sensor non-reactive to X-Rays surface
2 Sensor active surface
1.12 Control Box
The sensor control box contains all the electronics of the sensor. The two LED light
shows whether the sensor is workable.
Figure 3
1.2 Technical Specifications
Sensor: APS CMOS sensor
External dimension (mm) :44×32() ; 40×26(AT-301)
Sensor Active Area : 36×27() ; 30×22.5(AT-301)
Sensor Thickness : 6mm
Dynamic Range : 0~4,096
Power : 5V±0.5V
Image Transfer :USB2.0
Cable Length :.≥ 3m
1.3 Sharing the Sensor Between Rooms
You can share the sensor between several rooms to provide access for several dentist
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based on ATE CO Server software. The computer must have the AT ECO Dentist
dental imaging software, and ATECO Server must installed in one computer.
To share the sensor between several computers, move it from room to room. When
you connect the sensor to a USB 2.0 port on the computer, the sensor is recognized
automatically and is operational.
To share data between rooms, you can connect them to remote data---ATECO Server
database. The AT ECO Dentist dental imaging software needs only to access a shared
database on the same computer or on a remote computer, which means AT ECO Server
database.
1.4 Using the different Positioning Systems
There are two ways to position the sensor in the patient mouth to get an classic
radiology. You may spend some time to adapt due to the rigidity of the sensor.
One method is angular bisector technique, the other method is paralleling technique. It
is just the way to position sensor, which can be chosen by practitioner’s experience.
X-Ray Generator Compatibility
Normally, the sensor is compatible with all generators which meets the present
standard of intraoral radiology. Yo u can use a high frequency or conventional
generator. To achieve gaining better images, the generator must operate with a voltage
of 65 to 70kV.
1.5 Attentions
1 As a precision devices, avoid flop,pulling and long-time disinfectant soak
2.Put disposable plastic jackets before used, avoid cross infection and allergy
3.No bite, for fear that the sensor or the jacket been broken
4.Caution for epileptic or psychopath
5.Learn the user manual carefully before use
6.User should be the professional dental or technician
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2. Imaging Software General Introduction
2.1 Computer System Requirements
Processor: Intel 1.2GHz chip or above;
Memory: Above 1G ;
Hard disk: Above 40G;
Interface: USB 2.0;
Display: Resolution 1024 × 758 (15") or above
Operating System: Windows XP
The computer connected to system shall be in accordance with IEC 60950-1:6005.
2.2 Imaging Software
The Ateco AT-301 dental imaging system operates with the following software:
Atecotech
Atecotech Server for sharing information between workstations.
Atecotech Software is a user-friendly working interface that was designed and
developed specifically for radiological diagnosis. It is the common imaging platform
for all our digital systems for dentistry.
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3. Driver Installation
1. Insert the CD into CD-ROM or DVD drive ， browse CD then double click on the
icon to continue. It will show
2. Click , it will show
3. Click , it will show
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4. lick , it will show
5. Cl
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ick , the driver is installed.
Then connect the sensor to computer via USB cable, the computer will recognize it, and will show
it is ready to use.
4. Software Installation
Double-click on the My Computer icon on your desktop, then open the CD-ROM
drive by double clicking.
1. Click the button on the interface of the CD or double-click the icon in
the CD, and then it shows:
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2. Choose the required language.
3. Click on the button ,
4. The default destination folder is “D: /Atecotech”. If you want to change the route,
please click on the button of to select the folder you want.
Then click on , and then it shows
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5. Click on , then it shows. There are two selections for creating the icon,
please make the selection according to your needs click , then it shows:
6. Click on the button , then it shows:
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7. Click on the following window will be shown:
8. When the installation is finished, the following window will be show:
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9. Then click on the button , the whole installation was completed and the
software will be launched automatically, and there will be a shortcut on the
desktop.
5. Install Calibration File
Install To Atecotech
Provided with every sensor is a disk containing the sensor calibration file. Each
calibration file is unique to the sensor it was shipped with and the file must be
installed on every computer systems before using that sensor. Every calibration file is
consisted of 3 files , copy these 3 files from the CD and then paste into software
installed destination folder , the default destination folder is
D
:\Atecotech\Sensor
.And then the calibration files installation is finished .
Copy the 3 files under “Calibration file” in CD and paste them into the correct
installation path file folder, then it’s finished.
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6. Register Key
30 days later since the date of software installation, the software will ask for register.
Double click on the target frame, register key windows will come.
Please remember to register the software within 30 days of installation.
Click on Help in menu bar then select Register .
Input the information in the frame, and then click on Send Registration button, in
normal situation, there will be a auto-run email jumping out.
If your computer have no email support server, you may meet the following notice.
Please click on OK and then click on the button of Export Req file .
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7. Software Operation
User interface
Double click on the icon to launch the software, the Atecotech window will
be shown:
Example Screen:
1.System menu of the program windows
2.Menu bar
3.Tool bar
4.Patient account list
5.Teeth chart
6.Target frame
7. Image information
Menu Bar
Each item contains a drop-down menu, and some of function can be achieved directly
from the icon in toolbar
Change language
Click on Tools(T) on the menu bar and select Option.
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Click on Display, then select the your target language.
In Recent history part, there are two options, it arranges the order of First name and
Last, this depends on countries custom .
Please click on OK, it will show
Click OK, the software will be restarted automatically and switch to be the language
you selected.
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Toolbar
Each button contains a icon and will show a short message to explain corresponding
function by moving the mouse pointer to the icon.
Establish Patient account
1. Click the icon in the toolbar or select new patient in file of menu bar
Then it will show
Input patient information ,select picture series and you can also input study comments
in the frame and then click on OK . The new patient account has been created .
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Target frame (18 pcs)
If the first one is full (Maximum 20 images for each account )
Click on for creating another account under the same patient.
For establishing a account for another patient , please select “ new patient ” in this
windows
A new patient case has been created successfully.
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Delete patient account
Please select the patient case that you want to delete it will show the following notice
window
Click on “Yes”, and this patient will be deleted.
Search a patient case
Click on this icon, and input the patient information, the target patient patient will be
showed.
Input basic information of patient and click on search button to find a detailed patient
account.
Please attention that the software only display 30 pcs recent patients case , all others
will be hiden inside , so it need search tool if the patient case was not display in
patient Data area .
Edit basic information of patient
Click on this icon, and the Patient Info window will be show:
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If there is something wrong with the basic information of the patient, it could be
modified here.
Tile
Pave several pictures together (the maximum quantity is 6).
Keep on pressing the “ctrl” on the keyboard for selecting several pictures at the same
time, then click on this icon, and the pictures selected will be tiled.
Press “ESC” to exit.
Play
Click on this icon to view the image one by one.
The default time is 3 seconds and it could be changed depend on your requirement.
Press “ESC” to exit.
Edit Image
Select a image then click on this icon to open “ ATECO Image” windows, and you
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can also open it with double-click on the image. More information refers to 9.3.
Delete Image
Select the image you want to delete then click on this icon. The following windows
will show
Choose “yes” or “no” to delete the image or not.
Export Image
Select a captured image then click on this icon to export this image.
Copy & Paste
Right click on the image, there will be a pull-down menu.
Select copy and then choose a empty target frame right click and select paste, this
image will be paste into another frame.
Refresh images
Click this icon to refresh the images, or
Right click on any image, and then select Refresh images.
Print Image
Note: To achieve this function, please be sure that the computer has been connected to
a printer.
Print one image: left-click on that target frame and then click on print icon in the tool
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bar directly.
Print more images: Keep on pressing the “ctrl” on the keyboard and then left click on
the target frames to select several frames at the same time, then click on this icon to
print these selected images.
* Before use the hardware, please chick the equipment icon first:
The icon is for Intraoral Camera or Film Reader.
The icon is for Intraoral X-ray Sensor.
8. Acquiring an Image
To acquire an image with the AT-301sensor, follow the instructions in the presented
order.
8.1 Preparing the AT-301sensor
To prepare the AT-301sensor, follow these steps:
Select an appropriate positioner for the region of interest and the sensor size.
Cover with a disposable hygienic sleeves specifically designed for each sensor size.
Notice: To prevent cross-contamination, use a new hygienic sleeve for each new patient.
8.2 Preparing for Acquisition
To prepare for acquisition, follow these steps:
1 Open software, establishing the patient account
2 Click to access the capture interface, or double click the blank frame .
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3 Select the x-ray timing according to the region of interest and the patient type
(follow the user instructions of your x-ray generator).
4 Insert the sensor holding it horizontally in the patients mouth. Positioning in the
patient’s mouth depends on region of interest.
5 Approach the x-ray generator tube head to the patient.
6 Align the x-ray tube head with the patient’s tooth and the sensor and make sure that
the tube head is not shaking.
8.3 Launching the X-Ray
To launch the x-ray, follow these steps:
1. Ask the patient to remain still
2. Position yourself either 2 meters behind the x-ray generator or outside the door.
3. Keep visual contact with the patient during the x-ray generator.
4. Trigger the x-ray with the remote control of the x-ray generator.
The image appears in the capture windows of the capture interface.
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The image has been captured and the information frame return back to green color.
It’s ready to capture another image, without closing the window.
As soon as the image was captured it will be saved into software.
5. Check the image quality. If not satisfactory, redo the x-ray.
6. If satisfactory, remove the generator tube head.
7. Remove the AT-301sensor from patient’s mouth. Remove the hygienic sensor
protection.
Notice: DO NOT pull the sensor by its cable when you remove the hygienic protection.
Note: First of all, please confirm that you have installed the calibration files, more
information refers to chapter 9.
Connect the sensor to the controller then connect it to computer
The power indicator light will shine, and then the working indicator light will flash
green light.
Using disposable sheath
Please place the sensor on the holder and cover the sensor with disposable sheath,
then place the sensor into patient’s mouth with flat side facing the X-Ray tube.
Double click on the target frame again, the capture windows will show:
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The capture windows will come and appear flash green light (default setting) .
The sensor ID # of the sensor you are using is shown directly on the title.
And it will remind you if the calibration file hasn’t been installed in the
meanwhile.
Active the x-ray source.
After activate the x-ray source , the sensor will detect the x-ray automatically and it
will show .
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The green flash frame will change to be yellow color , it means that the sensor has
detected the x-ray successfully .And around two seconds later , the image will be
captured as below show .
Advanced Settings
If you find out that some images need do some imaging process to enhance the image
quality, you can use Advanced Settings
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And you can slide these buttons one the left to adjust to what you expect on the right
side, and next time you will take the image just exactly you want to enhance without
any other action.
**However, we will recommend you keep the default figures in normal cases.**
** To optimize the final image processing quality, please adjust the window level first
and save to a new picture, then using processing function buttons on this saved new
picture. **
The image has been captured and the information frame return back to green
color .It’s ready to capture another image ,without closing the window .
As soon as the image was captured it will be saved into software .
For taking another x-ray image, please repeat this procedure.
! Important: When the device is not in use, please disconnect it form USB port to
avoid over heat.
! Important: The disposable sheath is for single use; please change it for every patient.
! Important: The disposable sheath shall conform to ISO 10993.
9.2.8. Working Sketch map
（1） （2） （3） （4）
Descriptions:
(1) x-ray source
(2) Tooth
(3) Digital x-ray sensor
(4) Connect to computer via USB cable
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The icon is for Panoramic Machine.
ATE COImage(Enhance image)
9. Ateco Image
For enhancing the original image quality please double click the target frame with
image or click on the button of to come into AT E C OImage.
ATE CO Image Toolbar
To apply the function, click on corresponding button.
Apply this tool for come back to original image at one time .
.
Undo: Used to withdraw the previous operation Redo: Used to
repeat previous operation.
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Choose the display mode you prefer.
This function is used to view the image from different angle .
Click this button,there’s a small window for choosing the magnifier
parameter you prefer.
This function was set for making a mark on the image the pinot out the tooth problem
and for better communication between patient and dentist.
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Click on this Drawing icon, then keep on left pressing of mouse, then move the
pointer on the picture, the red line will appear following the mouse pointer .
Click on this icon, the following windows will show
Left Click on two points that you want to know the distance. And left frame will show
the distance, and this is only for reference, not accurate.
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And if you calibrate the image taken from other brand sensor or intraoral camera, you
will need calibrate first.
Color Adjust
Color adjusted by moving the slider either to left or right depending on your needs.
Bright/Contrast
Brightness and contrast could be adjusted also by moving the slider to left the to
decrease the brightness/contrast, move the slider to right to increase.
Desoft
To remove useless soft tissue and adjust gamma value to improve the image quality
for those unsatisfied pictures:
Before After
Image process
There are eight feature buttons listed in this section, to achieve its function just by
clicking on corresponding button.
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Inverts the gray shades of the image-negative images appear as positive, and positive
images as negative.
Before Negative After Negative
Click on the colorize button, you’ll notice the significant color contrast between
different elements of the image.Because some differences can be easier to distinguish
in color,colorizing provides antother means to identify potential problems areas
during examnations.
Before Colorize After Colorize
This function can optimize your image.
Before Embossment After Embossment
Show better structures and improve underexpose or overexpose images’ quality.
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Before Normalize After Normalize
Removes fixed pattern noise from an image.
Before Denoise After Denoise
Make the images smoother
Before Soft After Soft
Simulation Diagosis
In order dentist have a better dental practice and more easy to dignose for particular dentition.
Saprodontia,Root Canal, Periodontal, Crown and Diagosis,four different enhanced image make
easier to check.
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And With one button of Dignosis, you will see four different enhanced image.
By Pressing this button the edited image will be saved automatically. And it
will give the following notice.
Click on (Y), the edited image will be saved into software automatically.
10. Troubleshooting Images
Troubleshooting images using the troubleshooting table below. If the problem persists,
or if it is not outlined below, contact your representative.
Notice: If the malfunction persist or more serious conditions occur, contact your
representative.
Table 1
Malfunction
Possible Cause & Action
No images is displayed after triggering
the x-rays.
Make sure the capture window is open,
Check the connection of the sensor on the
USB2.0 port.
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The image is pale, too light
The exposure time is too short; increase
it.
The generator voltage is too low; have
the generator checked.
The generator is too far from the patient
with respect to the selected dose.
Check the monitor setting (contrast and
brightness) and ensure there are no
reflections on the screen.
The image is too dark.
The exposure time is too high; lower it.
Check the monitor setting (contrast and
brightness) and ensure there are no
reflections on the screen.
The image is blurred.
Patient moved during exposure.
Generator head was not stable
Use an image filter.
The image is white.
Active face of sensor was not exposed to
x-rays.
X-Ray dose is insufficient.
Sensor is not connected, or is
improperly connected.
Ensure the generator is producing
x-rays; have it checked by a certified
technician.
There is white lines on the image
Make sure install the calibration files.
11. Maintenance
11.1 Visual Inspection
Like all electrical equipment, the product requires not only correct use, but also visual
inspection prior to operation, and routine checks at regular intervals. These
precautions will help ensure that the product operates accurately, safely, and
efficiently.
Before operating the system, users shall check it for any signs of physical damage or
defect. If detected, contact your local distributor of this product for further
instructions.
11.2 Periodic Maintenance
Periodic maintenance is performed as needed, but at least once a month. It consists of
various checks performed by the operator or by a qualified service technician.
Check that the labels are intact, readable, and adhere well to the surfaces on
which they are positioned
Check that all of the cables are undamaged
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Check that there is no external damage to the product which could compromise
its ability to operate safely
Check the installation, then do the step 1, 2 and 5 of operation and check that the
indicator lights and indicator area in software are in normal.
11.3 Cable Care
Improper coiling of a sensor's cable is the most common cause of the sensor failure.
The following instruction is important to be followed for preventing cable damage.
Grasp the connector not the sensor cable when disconnecting the sensor from
USB control box. Pull it gently.
Once unpacked, never coil the sensor cable, repeated coiling may cause kinks and
irreversible damage.
Store the sensor in its holder when it's not in use.
Don't let the cable hang on or near the floor where can become tangled.
Don't tangle the cable during use.
Note: The length is actual only when it was calibrated. If not, the value is just for
reference.
11.4 Damaged or Non-Functioning Sensor
In the event of obvious physical damage to the Sensor or in the event that the sensor
can’t work properly, customers shall discontinue use of the Sensor, and contact their
local distributor of the products to substitute another Sensor if available.
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12 .Warranty
The Ateco Technology Company guarantees for a period of essential 18 months
for the sensors products starting from the date of the delivery , that the
aforementioned product does not contain any defects neither in the materials used nor
in the manufacturing process. This guarantee is only applicable where the product is
correctly used and maintained.
Only damage affecting the products themselves will be taken into account.
The customer shall on no account have a claim for compensation of damage that does
not affect the product as such. This exclusion of liability shall not apply insofar as
mandatory law provides otherwise.
This warranty does not cover damages and faults caused by accident, incorrect
or excessive repetitive use, negligence or general wear and tear due to normal
everyday use.
Ateco Technology Ltd. cannot therefore be held responsible for any consequences
resulting from the non-application of the instructions contained in the installation and
user manuals, namely bodily harm, profit loss, loss of production, data loss, financial
loss or any other direct or consequential damage.
If, however, the product is proven to be defective or faulty in materials or
manufacture, the responsibility of Ateco Technology Ltd. will be limited to the repair
of the aforementioned product at Ateco Technology Ltd. ‘s premises or, at Ateco
Technology Ltd. discretion, its replacement. Regardless of the solution chosen by
Ateco Technology Ltd., the customer must return the faulty product at his own
expense. Other than cost incurred for repair, cost of spare parts and labor, Ateco
Technology Ltd. will only take on the cost of return to the delivery address initially
communicated by the client.
Ateco Technology Ltd. shall be given the opportunity to examine any alleged defect.
Customers are not entitled to withhold payment of invoices or make deductions
on account of products claimed to be defective.
Due to the continuous development of its products, Ateco Technology Ltd. reserves
the right to amend at any time and without justification or obligation to notify those
concerned the manual and products mentioned therein.
Given that our products are guaranteed in their original packaging at the point when
they leave the place of manufacture, Ateco Technology Ltd. cannot be held liable for
any damages caused during transportation.
Consumable spares, software and accessories are excluded under this warranty.
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13. Notice
13.1 Indication of Use
The Digital dental X-ray imaging system is intended to generate intraoral x-ray
image ,require to working with x-ray source and imaging software in dental clinic for
dentist and orthodontists.
13.2 Brief Introduction of this Manual
This manual consist of the safety issue, AT-301 brief introduction, software
introduction, how to use sensor and the warranty policy.
13.3 Manufacturer
Manual Name: Digital Dental X-Ray Imaging System Manual
Revision Number: 01
Print Date: December, 2015
The Brand names and logos reproduced in this manual are copyright.
ATEC O is a trademark of ATECO used under license.
The system shall be in accordance with IEC60601-1-1. The person connect the
product to the host computer shall insure its compliance.
13.4 Packinglist
1. Manual 1pc
2. CD 1pc
3. X-Ray Sensor with controller 1pc
4. Holder 1pc
5. Sleeves 1 bag
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13.5 Symbols
Marking and Labeling Symbols
Symbol
Description
Caution , refer to accompanying documentation
Class-Ⅱ Device
Type BF applied part
Manufacture’s serial number
MANUFACTURE
Manufacture’s name and address
FRAGILE
Contents of the transport package are fragile therefore it
shall be handled with care
THIS WAY UP
Indicates correct upright position of the transport package.
KEEP AWAY FROM RAIN
Transport package shall be kept away from rain.
Antiroll
Max and Min. temperature
Indicates that in the European Union, at the end of product
life this device must be disposed of in accordance with the
requirements of the Waste Electrical and Electronic
Equipment (WEEE) directive 6002/96/EC
Conforms to European Union Medical Devices Directive
(MDD) 93/42/EEC
Label Location
The following Figure indicates the label locations of The AT-301 and Systems.
Figure 1 AT-301 and Label Locations
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14. Safety issue
14.1 Check Sensor and controller before using them
Before each usage, check the outer surface of the Sensor and controller for any signs
of physical damage or defect. Sensor and controller surfaces should have a smooth
finish, with no evidence of chipping or damage. If detected, contact your local
distributor of this product for further instructions.
14.2 Protect Sensor from Potential ESD Damage
Like other electronic devices, Sensor is susceptible to electrostatic discharge (ESD),
particularly when the device is used in or around carpeted areas or low humidity
environments. During cable replacement, when Sensor contacts are exposed, it is
especially important to protect the device from potential ESD damage. Touching a
metal surface prior to replacing the cable will reduce the risk of damaging Sensor
components by accidental static discharge. The use of anti-static floor mats or floor
treatments (for example Staticide 6005/6002) will also help eliminate static build-up
in your office.
14.3 Do Not Touch Exposed Connectors on
Non-Medical Equipment and the Patient at the Same
Time
When the Sensor and controller are in use, avoid touching exposed connectors on
non-medical electrical equipment and the patient at the same time. The human body is
capable of conducting electrical current and may cause a shock hazard to patients if
appropriate safety practices are not observed.
14.4 Ensure Proper System and PC Workstation
Installation and Operation
The Sensor and controller have been determined to be in accordance with
international safety standards and are deemed suitable for use within the patient area,
which extends from the patient for a distance of 5 ft (1.5m). To comply with these
standards, do not operate non-medical equipment (such as a PC workstation) inside
the patient area. Outside the patient area, the presence of approved non-medical grade
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equipment and Listed / Approved / IEC 60950-1 certified Information Technology
Equipment (ITE) computer equipment is acceptable. The host computer (PC
workstation) should be CE-approved and conform to the Low
Voltage [73/23/EC] and EMC Directive [89/336/ERC]. The system shall be in
accordance with IEC60601-1-1. The person connect the product
to the host computer shall insure its compliance. Also, to help ensure optimal
performance, ensure that all software programs residing on the workstation are
virus-free and have been adequately tested so they will not impact imaging
applications after installation. Any questions please contact your local distributor
14.5 Safety Classifications
Safety Type: Class-Ⅱ BF
Power: DC5V Maximum 600MA.Rate of Work: Max 1W
Degree of protection against ingress of water: IPX7
Non AP equipment, non APG equipment
Mode of operation: Continuous operation
14.6 Conditions required in operation, transportation,
and storage
14.6.1 Operating conditions
Environment Temperature : +10℃～+40℃
Environment relative humidity : ≤95%；
Air pressure : 860hPa～1060hPa；
14.6.2 Transport and Storage conditions
Environment Temperature: -25℃~+60℃;
Environment relative humidity : 10%~93%;
Air pressure : 860hPa~1060hPa;
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15. Waste Electrical and Electronic
Equipment
15.1 Background
The European Union’s Waste Electrical and Electronic Equipment (WEEE) Directive
(6002/96/EC) has been implemented in member states as of August 13, 6005. This
directive, which seeks to reduce the waste of electrical and electronic equipment
through re-use, recycling, and recovery, imposes several requirements on producers.
ATECO Medical and its Dealers are committed to complying with the Directive.
15.2 WEEE Marking
All ATECO products subject to the WEEE Directive and shipped after August 13,
6005 will be compliant with the WEEE marking requirements. These products will be
identified with the “crossed-out wheeled bin” WEEE symbol shown below, as defined
in European Standard EN 50419, and in accordance with WEEE Directive
6002/96/EC.
This “crossed-out wheeled bin” symbol on the product or on its
packaging indicates that this product must not be disposed of with other
unsorted municipal waste. Instead, it is user’s responsibility to dispose of EE waste
equipment by handing it over to a designated collection point for the reuse or
recycling of waste electrical and electronic equipment. The separate collection and
reuse or recycling of Electrical & Electronic waste equipment will help to conserve
natural resources and ensure that it is recycled in a manner that protects the
environment and human health. For more information about where you can drop off
your waste equipment for recycling, please contact your local officials.
15.3 Reporting
According to the WEEE Directive, ATECO Medical or its Dealers will ensure that
information needed to calculate the financial obligations with respect to EEE products
will be provided as required.
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15.4 WEEE from Users other than Private Households
According to the WEEE Directive, ATECO Medical or its Dealers will fulfill its
obligations for the management of WEEE from users other than private households.
Furthermore, as required by the WEEE Directive, in order to enable the date upon
which the equipment was put on the market to be determined unequivocally, a mark
on the equipment will be placed to specify that the equipment was put on the market
after August 13, 6005.
15.5 Information for Reuse Centers, Treatment and
Recycling Facilities
After August 13, 6005, and as required by the WEEE Directive, ATECO Medical or
its Dealers will provide reuse, treatment, and recycling information for each type of
new EEE put on the market within one year of the date in which the equipment is put
on the market.
Information will include the different EEE components and materials as well as the
location of substances in these items. The information will be provided as a printed
document or in electronic media (on CD-ROM or by web download, for example)
15.6 Warning and Safety Instructions
For Device:
Read and comprehend this Safety Instruction before using the HDR500/600 Systems.
The operation and maintenance of this device must be taken charge by you.This device only
can be operated by the legally qualified persons.If necessary, have a authorized qualified
technician carry out inspection and maintenance operations.
This device must be installed in a X-ray room that complies with current installation
standards. From this location, Any visual or audio communication with the patient must be
maintained by you and the Acquisition interface module during exposure.
X-ray equipment is hazardous to patients and the operator if you do not comply with the
exposure safety factors and operating instructions.
This device must not be allowed to be operated if there is the threat of an earthquake. After
an earthquake, ensure that the device is operating satisfactorily before using it again. Failure
to observe patients to hazards.
DO NOT place any objects within the field of operation of the device.
Connect this equipment ONLY to a mains power supply with protective ground to avoid any
risk of electric shock.
Disposing of the device or its components must be executed by a qualified service technician.
Never be allowed to modify the device.
This device is never allowed to be applied in conjunction with oxygen-rich environments.
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Nor intended for apply with flammable anesthetics or flammable agents.Using accessories
other than those specified in this document with the exception of those sold by ATEC O
Health may result in a lower level of security for the entire system.
For Computer:
DO NOT place the computer and the peripheral equipment connected toit in the immediate
vicinity of the patient in the unit. Leave at least 1.5m distance between the patient and the
unit. The computer and the peripheral equipment must conform to the IEC60950 standard.
Read your computer installation guide for details of the data processing system and screen.
Ensure the proper ventilation with leaving a sufficient amount of clear space around the CPU.
In order to acquire maximum image quality and visual comfort, direct light reflections from
internal or external lighting should be avoided when position the screen.
15.7 Hygiene and Disinfection Instruction
DO NOT place the sensor in an autoclave environment as which could cause serious damage
to the sensor.
Never immerse the RVG sensor in any solution.
The sensor head should be disinfected after each patient.
Do not apply chemical autoclave for the toothbrush holders and avoid direct contact with the
metallic part of the autoclave.
To prevent from cross-contamination , apply a new hygienic barrier for each new patient
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