Catalogue

Preface------------------------------------------------------------------------------------------------3
1 Production introduction-------------------------------------------------------------------------3
2 Product installation and function description----------------------------------------------5
3 Operation instructions--------------------------------------------------------------------------16
4 Notes----------------------------------------------------------------------------------------------63
5 Trouble shooting---------------------------------------------------------------------------------64
6 Cleaning, disinfection and sterilization-----------------------------------------------------64
7 Storage, maintenance and transportation-------------------------------------------------65
8 Environment protection------------------------------------------------------------------------66
9 After-sales service------------------------------------------------------------------------------67
10 Electromagnetic compatibility--------------------------------------------------------------68
11 Symbol instruction-----------------------------------------------------------------------------77
12 Statement----------------------------------------------------------------------------------------78
Preface
Thank you for purchasing the digital intraoral X-ray imaging system produced
by Guilin Woodpecker Medical Instrument Co., Ltd. Woodpecker is a high-tech
enterprise researching, developing, producing and selling dental products. It owns
a sound quality control system. To ensure that you use the equipment correctly
and safely, please read the full text of the instruction manual carefully before use.

1 Production introduction
1.1 Product introduction
The digital intraoral X-ray imaging system is applicable for oral two-
dimensional image photographing, case diagnosis, and information management.
Features:
a) Ultra-high image resolution can provide doctors with clearer diagnostic
images.
b) High-quality user interface makes photographing and reading easier.
c) User-friendly design makes the photographing process more comfortable.
1.2 Model
i-Sensor H1
1.3 Configuration
Equipment configuration is detailed in packing list.

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1.4 Structure and Components
This equipment is composed of X-ray sensor, USB transmission cable,
disposable protective sheath, sensor bracket, image management software
system and other parts.
1.5 Scope of application
It is mainly applicable for oral two-dimensional image photographing, case
diagnosis and information management.
1.6 Contraindications
Pregnant women and young children should be cautious to use the equipment.
1.7 Device safety classification
1.7.1 Type of operation mode: Intermittent operation
1.7.2 Type of protection against electric shock: Class Ⅰ equipment
1.7.3 Degree of protection against electric shock: BF type applied part
1.7.4 Degree of protection against harmful ingress of water: IP67
1.7.5 Degree of safety application in the presence of a flammable anesthetic
mixture with air, oxygen, or nitrous oxide: Equipment cannot be used in the
presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
1.8 Primary technical parameters
1.8.1 Power adapter input: 5V/USB interface
1.8.2 Effective area: 20*30mm
1.8.3 Pixel matrix size 1000*1500

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 1.8.4 Pixel size 20μm
1.8.5 Effective resolution ＞ 8lp/mm
1.8.6 Specifications: 38.5*25*4.5mm
1.8.7 Weight: 118g
1.9 Operation environment
1.9.1 Environment temperature: 5℃～ 40℃
1.9.2 Relative humidity: 30% ～ 75%
1.9.3 Atmospheric pressure：70kPa ～ 106kPa

2 Product installation and function description

2.1 Schematic diagram of the whole machine

Figure 1 X-ray sensor

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2.2 Installation of accessories
2.2.1 configuration requirements
It is a must to first ensure that the computer and its peripheral devices do
not cause any restrictions that may cause personal safety when using the digital
intraoral X-ray imaging system. The computer system must also meet the following
configuration requirements:
Windows®: Minimum configuration Maximum configuration
Operating
Windows® XP Pro SP3 Windows® 7 Pro SP1
system
Processor Intel® Pentium IV – 1.3 GHz Intel® Core 2
Memory 512 MB 2 GB or above
Hard disk 250 GB 320 GB or above
USB port 2 high-speed USB 2.0 ports 4 high-speed USB 2.0 ports
32 Mb memory graphics card, Nvidia chip graphics card or ATI
Display board
compatible with DirectX 9 discrete graphics card
USB chip Intel or NEC® / RENESAS® Intel or NEC® / RENESAS®
Display
1024 x 768 1280 x 1024 or above
resolution

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 X-ray generator compatibility
Digital intraoral X-ray imaging system is compatible with dental X-ray machines
that comply with regulatory standards on the current market.
2.2.2 Software installation
a) Double-click to run the "Ai-Dental setup.exe" installation program.

Figure 2
b) After the installation program starts, click the "Browse" button to select the
installation path. After the path is selected, click the "Next" button, as shown in
Figure 3:

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 Figure 3
c) Select the component. The user selects the corresponding component as
needed, and then click the "Next" button, as shown in Figure 4:

8
 Figure 4
d) Choose whether to create a shortcut. The user selects the corresponding
items as needed and clicks the "Next" button after completion, as shown in Figure
5:

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 Figure 5
e) According to the user's choice, the installation program displays the
component to be installed and the shortcut to be added. The user can click "Back"
to modify or click "Next" to install, as shown in Figure 6:

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 Figure 6
f) After clicking the "Install" button, the program starts to install. The user can
wait for the installation to complete, as shown in Figure 7:

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 Figure 7
g) The Driver Installation Interface as shown in Figure 8 ,click “next step”, the
Driver Installation is finished.

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Figure 8

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 Figure 9
h) After the database is installed, the installation completion interface is
displayed. Click "Finish" to exit the installation program, and the software is
successfully installed.

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 Figure 10
2.2.4 Installation of support frame
The sensor support frame is fixed on a flat wall by two screws. When the
sensor is idle, secure it on the support frame, as shown in the following figure:

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 Figure 14

3 Operation instructions
3.1 Brief description of photographing steps
3.1.1 First, turn on the PC with the image software system installed and start
the image processing software.
3.1.2 Start the matching X-ray generator and set photographing parameters.
3.1.3 Put the protective sheath on the sensor and place the sensor in the
patient's mouth parallel to the long axis of the teeth, so that the effective surface of
the sensor is close to the teeth.

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 3.1.4 Move the generator to the patient's head. Ensure that the generator cone
is perpendicular to the position of the sensor. Press the generator switch.
3.1.5 After exposure, the imaging software downloads the X-ray image to the
screen for display.
3.2 Use of sensor protective sheath
In order to ensure the maximum health and safety of the patient, the sensor
must be used with a disposable sensor protective sheath. Pay attention to the
following points during operation:
1. Wear gloves to place the sensor protective sheath.
2. Replace the sensor protective sheath every time finishing photographing.
3. Place the sensor protective sheath in a dry and clean place.
4. The used sensor protective sheath should be disposed of together with
other organisms and potentially infectious waste.
5. It is better to use the sensor protective sheath specially designed for digital
intraoral X-ray imaging system.
6. When the sensor protection device is damaged while the patient is Being
examined or if the sensor is contaminated due to the removal of the protective
sheath, the sensor and the front 40cm cable must be thoroughly disinfected.
3.3 Software operation instructions
3.3.1 Login interface
Login interface

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 Figure 15
① The Name box cannot be empty to log in.
② At most 3 recently logged-in users can appear in the login area, sorted from
left to right in descending order of time.

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③ Choose "Automatic Login" to automatically log in after booting the software.
④ Click the "Login" button to log in.
Login cancel interface

Figure 16

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 ① Picture scrolling. Each picture is an advertisement. Clicking on the image
will open the local default browser to enter the ad details page.
② Login cancellation and status display page, click “Cancel” to return to the
login page. If you don't click, you will directly enter the main program after about
3s.
3.3.2 Main interface & patient module

Figure 17
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 Click the buttons in box 1 to select different interfaces: patient interface,
diagnosis interface, report interface and setting interface.
3.3.2.1 Patient interface
Patient toolbar
(1) The buttons in box 2, from left to right, are New Patient, Delete Patient, and
Modify Patient.
(2) Click "New Patient" to open the new patient window, as shown in Figure
18. Click the "Add" button to add patients after filling in information. Click "Cancel"
button to cancel adding patients and clicking the "X" button will prompt the user to
add/cancel adding patients. The avatar can be changed by clicking “change face”
and items with "*" in the basic information are required.

21
 Figure 18
(3) Click "Delete Patient" to open the delete patient window, as shown in
Figure 19. Select the "Yes" button to delete the patient, and select the "No" button
to cancel the deletion.
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 Figure 19
(4) Click "Modify Patient" to open the modify patient window, as shown in
Figure 20.

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 Figure 20
Patient information interface
(1) The patient information display area, as shown in box 3, has avatar, name,
age, and gender. Click “More Detail” and Figure 21 pops up to display more
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patient information. At this time, patient information cannot be edited.

Figure 21
(2) Patient search interface
General search: Enter keywords and click "search" to query patients.
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 Advanced search: Click "+" to open the advanced search function. Figure
22 appears below the box 4. Select the conditions in the figure to perform the
advanced search. Clicking again will cancel the advanced search and enter the
general search function.

Figure 22
(3) The patient list, as shown in box 5, will be updated after the user clicks
search. There are 5 items in the patient list, which are name, age, gender, new
date and last visit date. Click on the header to sort the patients by this field. By
default, the patient list is sorted in descending order of the most recent visit time.
3.3.2.2 Image preview interface
Click “Preview” in box 6 to enter the image preview interface.
Image filtering
This interface provides 5 kinds of image filtering: date, image source, image
analysis, tooth profile filtering, and all images
(1) Date filtering. Set the start time of the date and filter the image creation
time. The filtered images are displayed in the image list, as box 8.
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 (2) Image source filtering. There are 5 methods: All Images, i-Scan, Sensor,
TWAIN, and File Import. Selecting “All Images” means displaying all images
under the condition of the image source, and the other four are image acquisition
methods.
(3) Image analysis filtering. All Images, No Analysis, Excellent, Acceptable,
Unacceptable, respectively indicate that all images are displayed under the
conditions of image analysis, the image is not analyzed, very good, acceptable,
and unacceptable.
(4) Tooth profile filtering. All Images, Toothless, Tooth profile, respectively
indicate that all images are displayed under the conditions of tooth profile filtering,
no tooth allocation, and tooth allocation. Select “Tooth profile” and Figure 23 will
be displayed. Click the tooth profile to filter the image tooth profile. Click on an
image of the teeth and it will be displayed in the image list.

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 Figure 23
(5) All images. Set the filter conditions except the date to “All Image”. Set the
start date to the first date in the image and the due date to the current date, and all
images will be displayed in the image list.
Image list
The image list is shown in box 8. The right button of each image has 4
functions--print, export, delete and image information.
(1) Print function. Call the available printer to print the image.

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 (2) Export function. Export the image to a local disk for user convenience.
(3) Delete function. If you are not satisfied with the image, you can choose to
delete the image. If you want to restore the data within 30 days after deletion, you
can contact Guilin Woodpecker Medical Equipment Co., Ltd.
(4) Image information. Figure 24 pops up after clicking it.

Figure 24
The image type, tooth position, and X-ray voltage, current, exposure time, and

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dose area product can be set on the image information interface. Users can also
analyze images, write instructions and comments in the instruction and comment
input boxes, and set the satisfaction of the analysis results. Below the image
information, there is basic image information. When the user makes changes to
the information interface, the “Save” button and the “Discard Changes” button are
available. Click “Save” to save the information data to the server, click “Discard
Changes” to restore to the initial state.
3.3.2.3 Image acquisition interface
Click "Acquisition" in box 6, and the image acquisition interface will be
displayed, as shown in Figure 25.

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 Figure 25
Box 1: The i-Scan\Sensor\Twain\File Import at the top are the four ways to
acquire images, and the two drop-down boxes in the middle are the two buttons at
the bottom. When the acquisition method other than "File Import" is selected, the
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two buttons respectively display "Ready": start the device; "Save": save the image.
When the "File Import" acquisition method is selected, the first button displays
"Import". Click the first button, and a dialog box for image selection will pop up and
the image can be selected, as shown in Figure 26.

Figure 26
After the image is acquired, the acquired image will be displayed in box 4.
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The currently selected image will be displayed in box 3 for the user to view more
conveniently, as shown in Figure 27.

Figure 27
Box 2: Set the basic parameters of the digital intraoral X-ray imaging system.
Select the image in box 4. Set basic parameters for the selected image,
including tooth allocation, image type, voltage, current, exposure time, and dose
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area product. If the currently selected image acquisition method is "File Import",
the acquisition time can be set in box 4.
3.3.3 Diagnosis interface

Figure 28

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 Box 1:
Undo: After image processing, the undo function can be used, and the
last state will be restored after use.
Forward: Use the forward function to restore the state before last after
canceling.
Delete: Delete the currently selected image.

Export: Export image.

View image information: View the image information of the current image.

Select/add/delete image processing state: Click the "Add" button to save the
current image processing state and display it in the drop-down box. Select the

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state in the drop-down box to switch, and click the "Delete" button to delete the
currently selected image processing state (The final state, original state and initial
state cannot be deleted).
Box 2:
Click the preview image on the right to automatically display the original image.
When there are multiple images, the frame of the currently selected image turns
red.
Information display: Display image information.

Image deletion: Delete the image.

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 Figure 29
Box 3:
Maximize: the effect of clicking “Maximize” is shown in the following
figure:

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 Figure 30
Then click again:

38
 Figure 31
Close: Cancel the display of the current image (not delete).

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Box 4: Image processing tools

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 “Display: Display window”

“Zoom”
Adapt to the window: According to the size of the display window, zoom
the original image.
Zoom to 100%: Do not zoom the original image for display.

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 The original image is zoomed by selecting the drop-down box on the upper
right. The scroll bar below is also a zoom of the original image, and the maximum
is not more than 4 times.
“Rotate/Flip”
Rotate 90° counterclockwise

Rotate 90° clockwise

Flip left and right

Flip upside down

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“Image Correction”

Image brightness adjustment

Image contrast adjustment

Image gamma adjustment

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“Measuring”

Linear measurement

Angle measurement
Delete linear/angle measurement
Unit rotation
Whether to display the coordinate system

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“View”

Flashing light

Magnifier
“Enhance”

Pseudocolor

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 Reversion
“sharpening”

Relief operation

Silhouette enhancement
“Histogram”

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 Preview filtering

Filter the preview by selecting the conditions in the drop-down box.

Click the right button in the box 5 to display the filter window, such as the date
range window, photographing type window, etc. below.

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The black box on the left shows the filter icon and the drop-down box rotates.

i-Scan
Sensor
Twain
File Import

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 Image processing shortcut
The six buttons are some of the six image processing functions in box 4, which
are set in the setting interface.

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 3.3.4 Report interface

Figure 32
Quick access toolbar
As shown in box 1, the button functions from left to right:
New report, new page, delete page, horizontal fit, vertical fit, print preview,
print, set, export to PDF, open report, save report.
(1) New report. If there is an edited report page, a pop-up window will ask

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whether to save it. Click “Yes” to automatically save the current report to the server
and the new report page will cover the current report simultaneously. Click “No”,
the new report will cover the report page.
(2) New page. When the user needs to add more report pages, he can click
“New page”, and then one report page will be automatically added to the last page
of the current report.
(3) Delete page. The user can choose to delete the current page.
(4) Horizontal fit and vertical fit are based on width and height respectively, and
the report page is zoomed in and out in equal proportion.
(5) Print preview and print are printing functions.
(6) Setting. Set the report page. See 3.3.5.5 report page settings for details.
(7) Export PDF can export the current report to local disk for user's
convenience.
(8) Open the report, the system obtains the report saved to the server by the
current patient from the server, as shown in Figure 33. The obtained report is
searched in descending order of the newly created time.

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 Figure 33
(9) Save the report. Save the current report to the server, as shown in Figure
34. The “Name” field cannot be empty, and the current system time is named
"year, month, day-hour, minute, second" by default. Comments can be input in the
“Comment”. Click “Save” to save and click “Cancel” to cancel saving.

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 Figure 34
Image preview area
As is shown in Figure 35

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 Figure 35
Report page
A patient has multiple reports, and a report has multiple pages. The report
page is shown in Figure 37.
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 Figure 36
(1) Box 1: Clinic icon/text, patient information, report creation time, loaded by
default, not editable
(2) Box 2: image box. The right button has the functions of property, deletion
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and reversal. The property window is shown in Figure 37. The deletion function
clears the information of the image box. The image frame contains image and
image basic information (voltage, current, dose area product, image source, tooth
shape, acquisition time).

Figure 37
(3) Box 3: text box. The right button of the text box has property and delete
functions, as shown in Figure 38. “Delete” is to clear the text.

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 Figure 38
Text Size
Text Alignment
Text Color
Box Line Type
Box Line
Box Background
(4) Clinic information: clinic name, attending doctor, clinic address, clinic phone
number, not editable, automatic loading
Page switching
As shown in Figure 39: previous page, current/total pages, next page
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 Figure 39
Report page setting
As is shown in Figure 40

Figure 40
(1) Box 1: Image information is displayed at the position of the image:
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 Display image information on image
Displayed image information below image
Hide image information
(2) Box 2: Header:
Date, patient information, clinic icon
(3) Box 3: Footer:
Attending doctor, name of clinic, clinic address, phone number
3.3.5 Setting interface
Basic setting interface
(1) Set the system language. After switching the system language, the restart
will take effect.
(2) Select image save path
(3) Select data backup path
(4) Set the tooth profile. There are 3 tooth profiles: FDI, UNS and Palmer. 3
kinds of teeth with the same tooth profile have different names.

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 Figure 41
Clinic management
Clinic management is mainly for setting the clinic information. After the
interface is switched, the system will automatically save the clinic information. The
clinic logo has two forms (text and icon). After setting the clinic information, click
on the report interface to update the clinic information in the report interface.

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 Figure 42
Image processing
Image processing management is mainly to set the image processing shortcut
tools of diagnosis interface. You must select and only select six image processing
shortcuts. After setting, click the diagnosis interface, and the tools of the quick
access toolbar will be updated. The effect is shown in Figure 43.

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 Figure 43
IP setting
Enter “IP address” in the IP address input box. Click “Test Connection” to
connect the test. If the connection to the server is successful, "OK, Successful
connection" is displayed; if the connection fails, “Connection failed, please enter
correct IP address” is displayed. The effect is shown in Figure 44.

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 Figure44

4 Notes
4.1 Notes for sensor use
4.1.1 Be sure to place the sensor carefully.
4.1.2 Be sure to use a disinfectant wipe to clean the sensor.
4.1.3 Be sure to place the sensor on the holder.
4.1.4 Do not ask the patient to bite the sensor and connecting cable.
4.1.5 Do not put the sensor in water.
4.1.6 If a malfunction occurs, do not open the sensor.
4.1.7 Our company is a professional manufacturer of medical devices. The
maintenance, repair and modification of the product must be carried out by our
company or our authorized distributors. We are responsible for the safety of
maintenance, repair and modification only when they are replaced by the original
accessories of our company and operated according to the instruction manual.

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5 Trouble shooting
Fault Possible cause Solution
1. USB driver is not installed.
1. Reinstall the USB driver
2. USB driver is incorrectly
The software 2. Reinstall the USB driver
installed.
interface shows the 3. Re-plug the USB port
3. The USB port is not inserted
connection timeout 4. Contact the local
correctly.
distributor
4. The USB cable is damaged.
If the above methods can not eliminate the fault, please contact the distributor
to return the device to the manufacturer for handling. Do not try to open the casing
of this device and repair it yourself.

6 Cleaning, disinfection and sterilization

6.1 Cleaning and disinfection of x-ray sensor and USB cable
To further eliminate the latent danger of cross infection, in addition to using
disposable protective sheath, the sensor and the front 40cm cable should be
cleaned and disinfected before each patient is replaced for photographing. The
recommended disinfectant for cleaning and decontamination is 70% is opropanol.
It’s recommended to use a cloth sprayed with aldehyde-free disinfectant to wipe
and disinfect the surface.
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6.2 Unavailable cleaning and disinfection methods
a) Do not use hard tools to clean for avoiding abrasion.
b) The following disinfectants are forbidden: trichloroethylene, dichloroethylene,
ammonium hydrochloride, chlorinated hydrocarbons and aromatic hydrocarbons,
dichloroethane, methylene chloride and methyl ketone.
c) Do not spray the disinfectant directly on the X-ray sensor.

7 Storage, maintenance and transportation

7.1 Storage
7.1.1 This device should be handled with care, away from the source of the
earthquake, and should be installed or stored in a cool, dry and ventilated place.
7.1.2 Do not mix it with toxic, corrosive, flammable and explosive materials
during storage.
7.1.3 The product should be stored in an environment with a relative humidity
of 10%~93%, an atmospheric pressure of 70kPa~106kP, and a temperature of
-20℃ ~ +55℃ .
7.2 Calibration
In some European countries-especially Germany-current laws require the
quality of sensors to be checked through specially designed test cards (once
a month). Even when used in other countries that do not require this type of
calibration, it is recommended to perform this type of calibration regularly (once a
65
month) to ensure that the product can still be used for diagnostic purposes. The
calibration process is as follows:
Step 1: Connect the sensor and start the image management software.
Step 2: Place the test phantom in the field of view of the sensor.
Step 3: Set the matching X-ray generator parameters (60KV, 50mAs) and take
exposure photographing.
Step 4: Confirm whether the resolution is not less than 8lp/mm.
7.3 Transportation
7.3.1 During transportation, excessive impact and vibration should be
prevented. Handle it with care and avoid inversion.
7.3.2 It should not be mixed with dangerous goods during transportation.
7.3.3 Avoid sunlight, rain or snow during transportation.

8 Environment protection
The product does not contain any harmful ingredients. It can be processed or
destroyed in accordance with the relevant local regulations.
Part Toxic and harmful substances or elements
names (Pb) (Hg) (Cd) (Cr6+) (PBB) (PBDE)
X-ray
○ ○ ○ ○ ○ ○
sensor

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USB cable ○ ○ ○ ○ ○ ○
○: Indicates that the content of the toxic substance in all homogeneous materials
of the component is below the limit requirement in SJ/T-11363-2006 Limit
Requirements for Toxic and Hazardous Substances in Electronic Information
Products.
×: Indicates that the content of the toxic substance in at least a certain
homogeneous material of the part exceeds the limit requirement of SJ/T-11363-
2006.
(This product complies with EU RoHS environmental protection requirements.
At present, there is no mature technology in the world that can replace or reduce
the lead content in electronic ceramics, optical glass, steel and copper alloys.)
According to the Administrative Measures on the Restriction of the Use of
Hazardous Substances in Electrical and Electronic Products, the Regulations on
the Management of Recycling and Disposal of Waste Electrical and Electronic
Products and related standards, please observe the safety and use precautions
of the products and recycle or discard the products in accordance with local laws
and regulations after use.

9 After-sales service
Since the date of sale, if the device fails to work normally due to quality

67
problems, our company will be responsible for the maintenance with the warranty
card. Please refer to the warranty card for the warranty period and scope. This
product does not contain self-maintained parts, and the maintenance of this device
should be carried out by designated professionals or special repair shops.

10 Electromagnetic compatibility
For this device, special precautions regarding electromagnetic compatibility
(EMC) must be taken. The installation and use must be in accordance with the
electromagnetic compatibility information specified in this manual. Portable and
mobile radio frequency communication equipment may affect this device.
The following cables must be used to meet electromagnetic emission and anti-
interference requirements:
Name Cable length Whether to block Remark
USB cable 2m No EUT
The equipment or system should not be used close to or stacked with other
equipment. If must be used in this way, it should be observed to verify that it can
operate normally under the configuration used.
10.1 Guidance and manufacturer's declaration-electromagnetic emission
Guidance and manufacturer's declaration-electromagnetic emission

68
Digital intraoral X-ray imaging system is intended for use in the electromagnetic
environment specified below. The customer or the user should assure that it is
used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emission Group 1 Digital intraoral X-ray imaging system uses RF
GB 4824 energy only for its internal function. Therefore,
its RF emissions are very low and are not likely
to cause any interference to nearby electronic
equipment.
RF emission Class 1 Digital intraoral X-ray imaging system is suitable
GB 4824 for used in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic Not Power is less than 75W
emission conformable
GB17625.1

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Voltage Conformable
fluctuation/
Flicker
emission
GB17625.2
10.2 Guidance and manufacturer's declaration-electromagnetic immunity
Guidance and manufacturer's declaration-electromagnetic immunity
Digital intraoral X-ray imaging system is intended for use in the electromagnetic
environment specified below. The customer or the user should assure that it is
used in such an environment.
Immunity Test level Compliance Electromagnetic
test level environment - guidance
Electrostatic ±6kV contact ±6kV contact Floors should be wood, concrete
discharge discharge discharge or ceramic tile. If floors are covered
GB/T17626. ±8kV air ±8kV air with synthetic material, the relative
discharge discharge humidity should be at least 30 %.

70
Electrical ±2kV for power ±2kV for power Mains power quality
fast supply lines supply lines should be that of a
Transient ±1kV for Not applicable typical commercial or hospital
burst handpiece environment.
GB/T lines
17626.4
Surge ±1kV line to ±1kV line to Mains power quality
GB/T line line should be that of a
17626.5 ±2kV line to Not applicable typical commercial or hospital
earth environment.

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GB/T <5 % UT 5 % UT (>95% Mains power quality
17626.11 (>95% dip in dip in UT) for should be that of a
UT) for 0.5 0.5 cycle typical commercial or hospital
Voltage cycle environment. If the user of digital
dips, short <40 % UT (60% intraoral X-ray imaging system
interruptions <40 % UT dip in UT) for 5 requires continued operation
and voltage (60% dip cycles during power mains interruptions,
variations on in UT) for 5 it is
power cycles 70 % UT (30% recommended that the scanner be
supply dip in UT) for powered from an un interruptible
input lines 25 cycles power supply or a battery.
GB/T 70 % UT (30%
17626.11 dip in UT) for <5 % UT (>95%
25 cycles dip in UT) for
5s
<5 % UT
(>95% dip in
UT) for 5s

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Power 3A/m 3A/m (50Hz) The power frequency magnetic
frequency field should have the level
magnetic characteristics of that in a
field typical commercial or hospital
(50/60Hz) environment.
GB/T
17626.8
[NOTE: UT is the AC mains voltage prior to application of the test level.]
10.3 Guidance and manufacturer's declaration-electromagnetic immunity
Guidance and manufacturer's declaration-electromagnetic immunity
Digital intraoral X-ray imaging system is intended for use in the electromagnetic
environment specified below. The customer or the user should assure that it is
used in such an environment.
Immunity test Test level Compliance Electromagnetic
level environment - guidance

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Conducted 3Vrms 3Vrms Portable and mobile RF communication
RF GB/ 150kHz~ 3V/m equipment should
be used no closer to any part of the digital
T17626.6 80MHz
intraoral X-ray imaging system, including
3V/m cables, than the recommended
Radiated RF 80MHz~ separation distance calculated
GB/T17626. 2.5GHz from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Here the “P” is the maximum output rated
power of the transmitter provided by the
transmitter manufacturer, in watts (W). “d” is the
recommended separation distance, in meters (m).
The field strength of the fixed RF transmitter “b” is
determined by surveying the electromagnetic field
“a”, and “b” should be lower than the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbols.

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NOTE1: At 80 MHz end 800 MHz, the formula of higher frequency range is
applied.
NOTE 2: These guidelines may not be suitable for all situations. Electromagnetic
propagation is affected by the absorption and emission of buildings, objects and
human bodies.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/ cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment of fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field
strength in the location in which the digital intraoral X-ray imaging system is used
exceeds the applicable RF compliance level above, the imaging system should
be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the
digital intraoral X-ray imaging system.
b. In the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3V/m.
10.4 Recommended separation distances between portable and mobile RF
communication equipment and the digital intraoral X-ray imaging system

75
Recommended separation distances between portable and mobile RF
communication equipment and the digital intraoral X-ray imaging system
The digital intraoral X-ray imaging system is intended for use in electromagnetic
environment in which radiated RF disturbances is controlled. The customer or
the user of the imaging system can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the digital intraoral X-ray imaging
system as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum Separation distance according to frequency of transmitter/m
output power 150kHz~80MHz 80MHz~800MHz 800MHz~2.5GHz
of transmitter
/W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

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For the rated maximum output power of transmitters not listed in the above table,
the recommended separation distance “d”, in meters (m), can be determined
by the formula in the corresponding transmitter frequency column. Here “P” is
the maximum output rated power of the transmitter provided by the transmitter
manufacturer, in watts (W).
NOTE1: At 80 MHz end 800 MHz, the formula of higher frequency range is
applied.
NOTE 2: These guidelines may not be suitable for all situations. Electromagnetic
propagation is affected by the absorption and emission of buildings, objects and
human bodies.
Notes:
Without the explicit consent of Guilin Woodpecker Medical Equipment
Co., Ltd., unauthorized changes or modifications to the equipment may cause
electromagnetic compatibility problems of this equipment or other equipment.

11 Symbol instruction
Manufacturer Serial number

Type BF applied part Follow instructions for use

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 Date of manufacture Non-reusable

Handle with care Keep dry

Recovery Temperature limitation

Atmospheric pressure for
Humidity limitation
storage

Products comply with WEEE directive

12 Statement
All rights of modifying the equipment design, product technology or
accessories, manual and packaging content at any time are reserved to the
manufacturer without further notice.
(Please refer to the product packaging label for the production date, the
service life: 5 years).

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ZMN-SM-309 V1.0-200908