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Q/HD 14.73-08-SM V1.1

 Preface
Dear users:

Thank you for using Handy Medical’s Digital Dental X-Ray Imaging System
HDR-500/600 and the trust to Handy Medical’s products. We will provide our best
to ensure the satisfaction when you using the Digital Dental X-Ray Imaging
System HDR-500/600 .

The Digital Dental X-Ray Imaging System HDR-500/600 is operated through the
software HandyDentist. HandyDentist is designed to take full advantage of
HDR-500/600 . To get the best imaging and processing quality, the combine
between HDR-500/600 and HandyDentist is necessary.

To ensure your safety and effective use of the Digital Dental X-Ray Imaging
System HDR-500/600 , please read the manual carefully before use.

Handy Medical remind: Any copy of the contents in this manual is not allowed without the
permission of Handy.
Remark: For undated references, the latest edition of the referenced document (including any
amendments) applies.
 Content
1. Notice........................................................................................................................................1

1.1 Indication of Use........................................................................................................ 1

1.2 Brief Introduction of this Manual............................................................................... 1

1.3 Manufacturer.............................................................................................................. 1

1.4.Packing....................................................................................................................... 1

1.5 Symbols......................................................................................................................1

2. Safety issue............................................................................................................................... 2

2.1 Check Sensor and controller before using them......................................................... 2

2.2 Protect Sensor from Potential ESD Damage...............................................................2

2.3 Do Not Touch Exposed Connectors on Non-Medical Equipment and the Patient at

the Same Time.................................................................................................................. 2

2.4 Ensure Proper System and PC Workstation Installation and Operation...................... 2

2.5 Safety Classifications................................................................................................. 2

2.6 Conditions required in operation, transportation, and storage.................................... 2

3. Waste Electrical and Electronic Equipment...............................................................................3

3.1 Background................................................................................................................ 3

3.2 WEEE Marking.......................................................................................................... 3

3.3 Reporting....................................................................................................................3

3.4 WEEE from Users other than Private Households......................................................3

3.5 Information for Reuse Centers, Treatment and Recycling Facilities...........................3

3.6 Warning and Safety Instructions................................................................................. 3

3.7 Hygiene and claaned Instruction.................................................................................4

4. Handy Sensor General Introduction.......................................................................................... 4

4.1 Product Composition.................................................................................................. 4

4.2 HDR Sensor ............................................................................................................4

4.3 Technical Specifications............................................................................................. 5

 4.4 Sharing the Sensor Between Rooms ......................................................................... 5

4.5 Using the different Positioning Systems Attentions....................................................5

4.6 Attentions................................................................................................................... 6

5. Imaging Software General Introduction.................................................................................... 6

5.1 Computer System Requirements................................................................................ 6

5.2 Imaging Software....................................................................................................... 6

6. Working Sketch......................................................................................................................... 7

7. Driver Installation..................................................................................................................... 8

8. Software Installation................................................................................................................. 9

9. Registry & Activation..............................................................................................................10

10 Calibration File Installation....................................................................................................12

11 Software Operation.................................................................................................................13

12 Image Acquisition.................................................................................................................. 21

12.1 HDR sensor Preparation......................................................................................... 21

12.2 Image Acquisition Preparation................................................................................21

12.3 X-Ray Emission......................................................................................................21

13.Cleaning and maintenance......................................................................................................23

14. Maintenance.......................................................................................................................... 23

14.1. Visual Inspection................................................................................................... 23

14.2. Periodic Maintenance............................................................................................ 24

14.3. Cable Care............................................................................................................. 24

14.4. Damaged or Non-Functioning Sensor....................................................................24

15. Warranty................................................................................................................................24

16.Adjust exposure x-ray dose. ................................................................................................. 25

17.Troubleshooting..................................................................................................................... 25
Annex A. EMC table.
1. Notice
1.1 Indication Use
The Digital Dental X-ray Imaging System is intended to be used and operated by professionals
like dentists, radiographers or other specific staffs in hospitals or dental clinics to make use of
the converted signals as shown by x-ray images in the computer for reading, storing or
transferring for daily dental practice uses.
1.2 Brief Introduction of this Manual
This manual consist of the safety issue, HDR-500/600 brief introduction, software introduction,
how to use sensor and the warranty policy.
1.3 Manufacturer
Manual Name: Digital Dental X-Ray Imaging System Manual
Revision Number: 1.1
Print Date: July, 2020
The Brand names and logos reproduced in this manual are copyright.
Handy is a trademark of Handy used under license.
The system shall be in accordance with IEC60601-1. The person connect the product to the host
computer shall insure its compliance.

0123

Manufacturer

Shanghai Handy Medical Equipment Co., Ltd

Floor 2, Building No.11, Lane 177, Fulian Er Road, Baoshan District, Shanghai
201906, P. R. China
European Representative:
Shanghai International Holding Corp.GmBH
1.4.Packing
1. Digital Dental X-Ray Imaging System 1pc
2. USB Flash Disk 1pc
3. Manual 1pc
4. Holder 1pc
5. Warranty and Quality Control Card 1pc
1.5 Symbols
Marking and Labeling Symbols

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Label Location
The following Figure indicates the label locations of The HDR-500/600 Systems.
Figure 1 HDR-500/600 Label Locations

2. Safety issue
2.1 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.
2.2 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.
2.3 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.
2.4 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 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
2.5 Safety Classifications
Safety Type: BF
Power: DC5V Maximum 200MA.Rate of Work: Max 1W
Degree of protection against water resistance: IPX7 (Only applicable for the sensor head part.)
Non AP equipment, non APG equipment
Mode of operation: Continuous operation
2.6 Conditions required in operation, transportation, and storage
2.6.1 Operating conditions
Environment Temperature : +10℃～+40℃
Environment relative humidity : ≤93%；
Air pressure : 860hPa～1060hPa；
2.6.2 Transport and Storage conditions
Environment Temperature: -25℃~+60℃;
Environment relative humidity : 10%~93%;

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Air pressure : 860hPa~1060hPa;
3. Waste Electrical and Electronic Equipment
3.1 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. Handy Medical and its Dealers are
committed to complying with the Directive.
3.2 WEEE Marking
All Handy 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.
3.3 Reporting
According to the WEEE Directive, Handy Medical or its Dealers will ensure that information
needed to calculate the financial obligations with respect to EEE products will be provided as
required.
3.4 WEEE from Users other than Private Households
According to the WEEE Directive, Handy 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.
3.5 Information for Reuse Centers, Treatment and Recycling Facilities
After August 13, 6005, and as required by the WEEE Directive, Handy 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 USB flash disk or by web download, for example)
3.6 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.

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 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. 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 Handy 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.
3.7 Hygiene and cleaned 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
4. Handy Sensor General Introduction
4.1 Product Composition
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.
NOTICE: The computer and other peripheral devices like monitor, printer, etc. are
equipped by the user own self. For the suggested computer configuration, please refer to
5.1 Computer System Requirements.
4.2 HDR sensor

HDR-500/600
The sensor active surface is flat including the size 1 and size 2.

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 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 HDR Sensor

1 Sensor non-reactive to X-Rays surface

2 Sensor active surface
4.3 Technical Specifications

Model HDR-500 HDR-600

Sensor APS CMOS APS CMOS

External dimension (mm) 39×28.5 44.5×33.0

Sensor Active Area(mm) 30×22.5 36×27

Sensor Thickness 6mm 6mm

Grey Value 0~4,096 0~4,096

Power 5V±0.5V 5V±0.5V

Image Transfer USB2.0 USB2.0

Cable Length ≥ 3m ≥ 3m

4.4 Sharing the Sensor Between Rooms under proper installation and operation
The sensor could be used under net version through HandyServer software and accessed by
several dentists in different rooms as a working station . In this case, the HandyServer needs to
be installed in one computer which is as the database and other computers in different rooms
could access the data by remote.
Attentions: The HDR sensor and control box conform to the international safety standards and
are regarded to be applicable to be used in patient available area, namely, within 1.5m distance.
Within the patient available area, the (computer) devices used should be qualified as a medical
device and is compliant with GB9706.1(IEC 60601-1), YY0505(IEC 60601-1-1) standards;
outside the patient available area, the (computer) devices used other than a medical device
should be compliant with GB4943(IEC 60950); the whole working station configurations should
be compliant with GB9706.15(IEC 60601-1-2) standards and be verified by qualified station
staffs. In order to ensure the device’s normal performances, all programs used in the working
station should be without virus and under verification .
4.5 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.

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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. You can use a high frequency or conventional generator. To achieve gaining
better images, the generator must operate with a voltage of 65 to 70kV.
4.6 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
5. Imaging Software General Introduction
5.1 Computer System Requirements

Items Minimum configuration

PC processor Intel 1.5GHz chip or above

Memory Above 4G

Above 40G
Hard disk
(1GB for software installation,40GB for software operation)

Video card 256MB RAM

Resolution 1024 × 768 (15") or above
Display
32-bit color mode
At least 2 available USB2.0 ports/USB3.0 ports
Interface (If used desktop computer, 2 available USB ports must be have at the
back of compute)

Operating System Windows XP/Win7/Win10（32bit&64bit）

USB flash disk / Mobile disk

Backup medium (using mobile disk to avoid loss of patient data,some case like PC disk
is corrupt/full,PC is attacked by virus,etc.)
NOTICE:
 The computer and other peripheral devices like monitor, printer, etc. are equipped
by the user own self.
 The requirement form above is the suggested minimum configuration for the
computer and the product performance might be affected if those above are not
reached.
5.2 Imaging Software
The Handy HDR-500/600 dental imaging system operates with the following software:
 HandyDentist V3
 HandyServer for sharing information between workstations.
HandyDentist 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.
5.3 Network Security
Relevant electronic data in the software can be exchanged with multiple computers via LAN.

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Connect the computer to the local area network (router/switch) with an ethernet cable.
If necessary, consult a network administrator to establish a local area network.
The computer can automatically obtain an IP address (DHCP) or set it manually (static IP).

Notice ：

Set up a computer to act as a database server on the network;

Make sure that the software installed on the computer is used to view the images.
When any other computer is in use, the computer installed the server must be kept on.
Network requirements

TCP/IP protocol
Network connection setting
Gigabit Ethernet cable

anti-virus software
Security software
firewall

Attention ：

If the user of the network are disconnected from the network during the image

transmission process, the images could not be saved to the server. In this case, repair the

network, and after the network connection is normal, perform image transmission again.

6. Working Sketch
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

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indicator flash green light.
Working Sketch map

HDR-500/600

7. Driver Installation
We provide a USB flash disk together with the sensor in package. Please plug the USB flash
disk into your computer to start installation.
7.1.Open the USB flash disk and find the Driver icon HDR Sensor Driver 2.x.x.x(xxxxxxxxxx)
(The Driver name might change with update version, please refer to the actual using name)
7.2. Double click Driver icon, chose the language you’d like

7.3. Click

7.4. Click

7.5. Click to complete installation, then connect sensor to computer via USB wire,

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the sensor will be detected, and green blinking in shooting window shows it is ready to work.
You can check its right drive name in Device Manager.

8. Software Installation
8.1 HandyDentist
1 Find HandyDentist software icon HandyDentist_3.xx.xx(xxxxxxxxxx) (The Driver name
might change with update version, please refer to the actual using name)
2. Double click to launch install-shield wizard

Chose the ‘client’, then chose the language you’d like

3. Click ,select its installation path you want

4. Click , chose the below two options as needed

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5.Click → to continuing,after that,click to complete
HandyDentist software installation

8.2 HandyServer
When users need sharing the sensor between rooms, please follow up below installation and
operation
Software Installation(The server version is optional. The server version needs to be purchased
separately. please contact with your local deal to purchase.)
1. Find HandyDentist software icon HandyDentist_3.xx.xx(xxxxxxxxxx) (The Driver name
might change with update version, please refer to the actual using name)
2. Double click to launch install-shield wizard

Chose the ‘server’, then chose the language you’d like

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3. Click → → → to continuing, after that, click
to complete Handyserver software installation

4. Settings

Click ，select ‘Tools’ - ‘Options’ – ‘Database’

（Remark：Refer to 11 Software Operation）

Input the IP address in ‘Server IP’ according to that of HandyServer software（For example：
192.168.56.1）
Or input the Hostname in ‘Server Hostname’ according to that of HandyServer software（ For
example：DESKTOP-V9UV9V4）

9. Registry & Activation

9.1 HandyDentist Software Registration
After 30 days since the date of software installed, the trial version will be stopped, and ask for
an activation code, as well the registration window will be showed automatically for your side to
proceed with register.
If the registration window disappear, please follow the below steps:
1)Run the software, click button in menu bar, and select ;

2)Fill in the blank of the user information: Company/Email/Address/Phone,in which the

Company and Email information is required;

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3)Click button after the user information is be finished, save it on your
computer desktop, a file suffixed with ‘.req’ will be generated, then send this request file to your
local distributor or directly to our after-sales support:[email protected];.

4)We will reply you an activation file suffixed with ‘.act’ ,to activate your software by import
this file into registration window directly (No need to open this file);

5)Click button to import the activation file you received;

6)Successful registration information will appear to remind you your software has been
activated;

9.2 HandyServer Registration

After 30 days since the date of software installed, the trial version will be stopped, and ask for
an activation code, it will show as below:

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Please follow the below steps:

1)Run the software ,click button;

2)Fill in the blank of the user information: Company/Email/Address/Phone,in which the

Company and Email information is required;

3)Click button after the user information is be finished, save it on your

computer desktop, a file suffixed with ‘HandyServer.req’ will be generated, then send this
request file to your local distributor or directly to our after-sales
support:[email protected];.

4)We will reply you an activation file suffixed with ‘.act’, to activate your software by import
this file into registration window directly (No need to open this file);

5)Click button to import the activation file you received;

6)Successful registration information will appear to remind you your software has been
activated;

10 Calibration File Installation

10.1 On-line Automatic Installation
If the calibration file hasn’t been installed yet, a prompt box will pop up showing the calibration
file is being installed automatically at the first time of bring up the shooting window in
HandyDentist Software. This procedure is trying to connect to network to search its calibration
file and install the file automatically.

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10.2 Manual Installation
If the on-line automatic installation fails, the prompt box will disappear.
Meanwhile, an alarm message display in title bar to remind the absence of calibration file, that
means need to be installed manually.

Click ‘Calibrations’ button to bring up the interface for manual installation.

Choose ‘Install from file’ option, manually search for its calibration file saved on USB flash disk
packed together with the sensor.

Click ‘Calibrations’ button to bring up the interface for manual installation.

Choose ‘Install from file’ option, manually search for its calibration file saved on USB flash disk
packed together with the sensor.

The alarm message will be removed after calibration file installed successfully

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11 Software Operation
User interface

Double click the icon to run the software

Default name: Admin

Password: empty(on need put-in any character, click ‘Login’ directly)
Then you can click the ‘Menu bar’ - ‘Tools’ - ‘Options’ - ‘General’ to modify

Example Screen:

1.System menu of the program windows

2.Menu bar

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3.Tool bar
4.Recent Cases list
5.Teeth chart
6.Target frame
7.Image information
Menu Bar

Each option contains a drop-down menu that for you directly to chose certain functions.
Language Choice
Click Tools(T) button on the menu bar and select Option(O).

Click Display button, select the language you’d like

Click , it will show

Click ,the software will be restarted automatically and switch to the selected
language.
Toolbar

Each icon displayed on Toolbar can achieve corresponding function by clicked directly.
Put your mouse pointer on the icon, its function description will appear.

Establish patient record

Click this icon directly in toolbar or select “new patient” in the drop-down menu by click
“Operation” button in menu bar
It will show

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Select “New Patient” option to create a new patient record, fill in the patient information, select
picture series you’d like, also it’s available to write study comments in the bottom blank, then
click ‘OK’ button.

Target frame (18 pcs)

Take 18 pcs as an example, if this account is full (Maximum 20 images),please click ‘New
Patient’ icon, but no need to tick “New Patient” option as the below picture showing, keep the
same patient information, just create another new target frame for the patient.

Delete patient record

Please select the patient that you want to delete, click this button, it will show the following

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notification window

Chose “Yes” button, this patient will be deleted

Search a patient case

Click this icon to search registered patient by use its ID, last name or first name. An accurate
searching is based on the examination date.
Double click the target patient, ‘Searching’ window will be closed automatically, and back to
home screen, this patient will display and be chosen in the ‘Recent Cases List’ area.

Please note that only 200 patients will be displayed in the ‘Recent Cases List’ area, so this
search tool is needed when the patient you are looking for is not shown.

Edit basic information of patient

Click this icon, and the Patient Info window will be showed:

Modify patient information here when needed.

Tile
Pave several pictures together
Press and hold down “Ctrl” key, left-click to select several pictures at the same time (the
maximum quantity is 6), then release “Ctrl” key, and click this icon to tile those pictures.

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Press the “ESC” key to exit

Play
Click this icon to view image one by one
The default time is 3 seconds and can be changed depend on your requirement
Press “ESC” key to exit.

Edit Image
Select an image then click this icon to bring up “ Handy Image” window, which can also be
opened by double-click the image. For more information, please refers to below Handy Image
(Enhance image)

Delete Image
Select an image you want to delete then click this icon.The below window will be showed

Click “Yes” or “No” button to delete the image or not

File import
Directly click this icon to manually import an image from your mobile memory disk into the
patient record

Export image
Select an image then click this icon to export & save in your mobile memory disk

Copy & Paste

Right click an image, select ‘Copy’ in drop-down menu, then paste into a null target frame
choose

Refresh images
Click this icon to refresh images, or choose ‘Refresh’ option in drop-down menu by right click
any image
Print Image
Note: To achieve this function, please ensure that the computer has been connected to a printer.

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Print one image: Left-click to select a target frame,then choose this icon directly
Print more images: Press and hold down “Ctrl” key,left-click to select several pictures at the
same time,then choose this icon

Before using, please choose the correct icon first :

This icon is for Intraoral Camera or Film Reader.

This icon is for Intraoral X-ray Sensor.

This icon is to make other third-party hardwares which have Twain function compatible
to this software.

HandyImage(Enhance image)

For enhance original image quality, please double click the image or directly click button
to bring up HandyImage window

All of these feature buttons are use to change the attributes not the image itself.
All of these tools could be divided into six parts
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.

To enhance the contrast on the image

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 Before contrast After contrast

Before Sharpen After sharpen

Inverts the gray shades of the image-negative images appear as positive, and positive images as
negative.

Before Negative After Negative

click 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.

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 Before Embossment After Embossment

Show better structures and improve underexpose or overexpose images’ quality.

Before Normalize After Normalize

Removes fixed pattern noise from an image.

Before Denoise After Denoise

Make the images smoother

Before Soft After Soft

Simulation Diagnosis
In order dentist have a better dental practice and more easy to diagnose for particular dentition.
Saprodontia, Root Canal, Periodontal, Crown and Diagnosis, 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.

Handy Image Window Toolbar

Reload: Click to bring back original image.

Undo: Click to withdraw the previous operation.

Redo: Click to repeat previous operation.

Partition:Click to choose the display mode you want,drag a image from left list into
black square for comparison.

Relocation:Click to rotate image.

Magnifier:Click to zoom up part of the image.

Draw:Click to mark the image and double click to delete the mark then back to original
image.

Scale:Click to do measurement.

Save:click save a edited image.

12 Image Acquisition
To acquire an image with HDR sensor, please follow the instructions in order.
12.1 HDR sensor Preparation
1)Prepare a suitable locator.
2)Cover the sensor head with a disposable hygienic sleeve.
3)Connect the sensor to your computer,the power light will be on after normal connection,the
working light will flicker after 2 seconds.

23
 Notice: To prevent cross-infection, please use a new hygienic sleeve for each patient
12.2 Image Acquisition Preparation
1)Run software, establish the patient record.

2)Click directly or select ‘HDR USB Series’ in drop-down menu by right-click a null
frame,to bring up the shooting window.
On the second use,simply double-click a null frame to quickly bring up the shooing window.

The sensor ID will display properly in the title bar,and remind you the state of calibration file
installation.

3)Set exposure time according to tooth position (refer to the instructions of your x-ray generator)
4)Put the sensor horizontally in the patient's mouth(you can use a locator to fix the sensor)
5)Bring the x-ray generator tube head close to the patient
6)Align the x-ray tube head with the patient’s tooth and the sensor, make sure the tube head is
not shaking
12.3 X-Ray Emission
Before emit x-ray, please note the following:
1)Keep your patient from moving
2)Stay 2 meters distance away from the generator, or stay in the safe protection zone
3)Leave your attention to your patient while take shooting
4)Emit x-ray by using remote control
The image appears while green color convert to yellow, and can be saved automatically in
software, then the color return back to green for a new image acquisition, no need to restart the
shooting window

5)Check the image quality, shoot again if not satisfied.

6)Move away the generator if the shooting finished.
7)Take out the HDR sensor from patient’s mouth and take down the used hygienic sleeve.

Notice: DO NOT pull the sensor cable to remove the used hygienic sleeve

Advanced Settings

24
If you find out that some images need do some imaging process to enhance the image quality,
you can use Advanced Settings

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 LED
indicator be over heated.
! Important: The disposable sheath is for single use only; please change it for every patient and
dispose the used ones under local health authorities guidance on medical disposable products.
! Important: The disposable sheath used shall conform to ISO10993 biocompatibility
requirements, i.e. no cytotoxic, delayed type hypersensitivity, irritation or endothelial reaction.

25
Working Sketch map

（1） （2） （3） （4） （5）

Descriptions:
(1) x-ray source
(2) Tooth
(3) Digital x-ray sensor
(4) Connect to computer via USB cable
(5) Show the image in software
13. Cleaning and maintenance
The product can’t be dipped in liquids, and the disinfectants and cleaning agents should
not be used. The product shall be used with disposable sheet to achieve the disinfectant purpose
(Handy Company do not provider disposable sheets, please use the disposable sheets which are
compliant with ISO10993 biocompatibility requirements). Periodically clean the outside of the
sensor by soft cloth with a small quantity of alcohol. The disinfection and cleaning preparations
could damage the CMOS-sensor. The usage of disinfection and cleaning preparations is
considered to be a breach of the guidelines for intended use. The manufacturer cannot be held
liable for any damage resulting from incorrect usage. The operator will be held liable and bears
all risks.
• Do not put sensor in an autoclave.
• Do not put the sensor in an ultrasonic bath for cleaning and disinfecting.
• Remove coarse dirt before cleaned using a soft, lint-free cloth or wipe.
14. Maintenance
14.1. 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.
14.2. 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 thesurfaces on which they are
positioned
• Check that all of the cables are undamaged
• 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

26
lights and indicator area in software are in normal.
14.3. 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.
• 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.
14.4. 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.
Notice：
Inside the product,there is a PTC current limiter. The parameter is as below:
Vmax:6V, Ih:2A, Imax:100A, Isc:100A, 85℃, Class C3

15. Warranty
We guarantee that the product functions correctly and that there are no faults in the material or
workmanship for duration of 24 months starting from the release date and according to the
following conditions:
Following a reasonable complaint relating to defects or short delivery, we will provide a
replacement or perform repairs. Our factory reserves the right to perform repairs.
Claims of any other nature, damages in particular, are excluded. In case of default and gross
negligence or intent, the latter only applies if there are no compelling legal provisions opposing
it.
We shall not be liable for defects or their consequences if they are likely to be a direct result of
actions or modifications by a customer or third party.
The expectant lifetime of the product is 4 years under normal operating conditions. Calculation
method as below:
Lifetime(The calculation is based on the
The number of exposures
average 10,000 times shooting per year)
40000 4 years

16.Adjust exposure x-ray dose

As with conventional radiological devices,exposure time is depend on the performance of
generator,shape of patients and the target tooth.
The recommended x-ray generator exposure time for your reference in below table,re-set a
special parameter according to your practical experience to make the radiograph more clear.
. Tooth Position Recommended Exposure Time(Unit:s)
Adult with #1 or #2
Upper incisor/canine 0.18
Upper premolar 0.24
Upper molar 0.35~0.45
Lower incisor/canine 0.12
Lower premolar 0.18
Lower molar 0.24

17.Troubleshooting

27
 Fault Solution
Try another USB port and re-install the
Computer can’t recognize the sensor
driver program
Re-set the required x-ray parameters.Try to
No response after x-ray emission plug into the back USB port of computer
case, and re-install the driver program
‘HDR USB Series’ option disappear or
there is no response when double-click a Close all anti-virus program and rein-stall
null frame to intent to bring up shooting software and driver
window
Please refer to chapter 10 ‘Calibration File
Warning “Lack of calibration file”
Installation’
Try to reduce or increase x-ray dose and
Image is too dark or white
exposure time
Software stop working and remind you Please refer to chapter 9 ‘Registry &
it’s not registered Activation’
Lack of calibration file,please refer to
Vertical white line on image
chapter 10 ‘Calibration File Installation’

NOTICE:If any problem occurs during operation, please refer to the above
troubleshooting table first. If the problem persists, please contact the after-sales team for
support.

28
Annex A. EMC table
The following tables provide HDR compliance information to electromagnetic compatibility (EMC) and electromagnetic
immunity (EMI) standards. To ensure conformance, the customer or user must use the HDR in environments that are
consistent with these standards. USB cables used with HDR Interfaces must also comply with the same standards.
Table 1. Guidance and Manufacturer's Declaration - Electromagnetic Emissions
PLEASE NOTE: HDR is intended for use in the electromagnetic environment specified below. The customer or user of HDR
must ensure that it is used in such an environment.

Emissions Test Compliance Guidance

HDR uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions
Group 1
CISPR11

The Class A equipment is a equpment suitalbe for use in all

establishments other than domestic and those dirctly
RF emissions Class A connected to a low voltage power supply network which
CISPR11 supplies buildings used for domestic purposes.

Harmonic emissions N/A

IEC 61000-3-2

Voltage
fluctuations/flicker
N/A
emissions
EN 61000-3-3

Table 2. Guidance and Manufacturer's Declaration - Electromagnetic Immunity

PLEASE NOTE: HDR is intended for use in the electromagnetic environment specified below. The customer or user of HDR
must ensure that it is used in such an environment.

Immunity Test EN 60601 Test Level Compliance level Electromagnetic envirnment

Guidance

Floors should be wood, concrete or

Electrostatic discharge
±8 kV contact ±8 kV contact ceramic tile. If floors are covered
(ESD)
±15 kV air ±15 kV air with synthetic material, the relative
EN 61000-4-2
humidity should be at least 30%.

Electrical fast ±2 kV for power Mains power quality should be that

transient/burst supply lines N/A of a typical commercial or hospital
EN 610004-4 environment.

Mains power quality should be that

Surge ± 1 kV differential mode
N/A of a typical commercial or hospital
EN 61000-4-5
environment.
Voltage dips, short 0 % UT ; 0.5 cycle Mains power quality should be that
interruptions and voltage At 0°,45°,90°,135°, of a typical commercial or hospital
variations on power supply 180°,225°,270°and 315° environment. If the user of HDR
input lines requires continued operation during
EN 61000-4-11 0 % UT; 1 cycle and power mains interruptions, it is
recommended that the HDR be
70 % UT; 25/30 cycles N/A powered from an uninterruptible
Single phase: at 0° power supply or a battery.

0 % UT; 250/300 cycle

29
Power frequency (50/60 30A/m 30A/m Power frequency magnetic fields
Hz) magnetic field should be at levels characteristic
EN 61000-4-8 of a typical location in a typical
commercial or hospital
environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.

Table 3：Electromagnetic Immunity 2

Guidance and manufacturer’s declaration - Electromagnetic immunity
The Equipemnt is intended for use in the electromagnetic environment specified below .The customer or the user of the
Equipemnt should assure that it is used in such an enviroment

Conducted RF 3 V rms 3V Portable and mobile RF

EN 61000-4-6 communication equipment should
150 kHz to 80 MHz be used no closer to any part of
6 V in ISM bands HDR, including its cables, than
between 0,15 MHz and the recommended separation
80 MHz distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance:

Radiated RF 10 V/m 10 V/m

EN 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7
GHz for 80 MHz
to 800 MHz

for 800 MHz

to 2.5 GHz
Where P is the maximum output
rating of the transmitter in watts
(W) according to the transmitter
manufacturer and d is the
recommended separation in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
a
electromagnetic site survey,
should be less than the
compliance level in each
b
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people

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 due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the HDR is used exceeds the applicable RF compliance
above, HDR should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the HDR.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m

30
Table 4. Recommended Separation Distance between Portable and Mobile RF Communications Equipment and HDR
PLEASE NOTE: HDR is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or user of HDR can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and HDR as recommended below, according to
the maximum output power of the communications equipment.

Rated maximum output power of Separation distance according to the frequency of the transmitter (m)

the transmitter (W) 150 kHz to 800 MHz 800 MHz to 2.7 GHz
80Mhz to 800Mhz

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

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection

from structures, objects, and people

31
SHANGHAI HANDY MEDICAL EQUIPMENT CO.,LTD

ADD:Floor 2, Building No.11, Lane 177, Fulian Er Road,

Baoshan District, Shanghai 201906, P. R. China

TEL: 0086-21-56766108 FAX:0086-21-56766308

After Sales Service: Skype: handysupports E-Mail: [email protected]

Website: www.handydental.cn

European Representative: Shanghai International Holding Corp.GmBH

ADD: Eiffestrasse 80, 20537 Hamburg, Germany