Hamamatsu Photonics C10819 Series User manual

i
Digital radiography system, dental
C10819 Series
Read this instruction manual carefully before
using this product.
Attempting to operate this product by methods
different from those described in this instruction
manual may cause serious accidents.
Keep this instruction manual near the product
for easy reference when needed.
Instruction Manual
COPYRIGHT© HAMAMATSU PHOTONICS K.K.
Version 1.01
Document Number : K46-B60035
Document Revision : 1.02 18.Sep.2009
0120

1
Digital radiography system, dental C10819 Series
Hamamatsu Photonics K. K.
Precautions when using (safe and secure) Electronic Medical Equipment
1. User must read the manual and learn how to use.
Or please use it under the supervision of user who
knows usage.
2. Take care of the following while installing the equip-
ment. Install in a dry place.
(1) Keep in a place where there are no adverse
effects due to atmosphere containing pres-
sure, heat, humidity, air passage, direct sun-
light, dust, salt content or sulfur content.
(2) Take care of the safety status such as the
angle of inclination, vibrations, shocks (includ-
ing handling time), etc.
(3) Do not use in places where chemicals are
stored or where there is generation of gases.
3. Take care of the following before using the equip-
ment.
(1) Confirm that the equipment is running properly
by checking the switch position, display cate-
gory etc.
(2) Confirm that all the cables are correctly and
safely connected.
(3) Take sufficient precautions since using the
equipment widely would risk in errors in the
precise measurements and might create dan-
gers.
(4) Recheck the external circuits that are directly
connected to the patients.
4. Take care of the following while using the equipment.
(1) Do not exceed the necessary time for mea-
surement.
(2) Constantly monitor that there are no abnor-
malities in the entire equipment and to the
patients.
(3) In case any abnormalities are detected in the
equipment or the patient, take appropriate
measures such as stopping the operation of
the equipment while the patient is in a safe
state.
5. Take care of the following after using the equipment.
(1) Shut-off after returning the operational
switches to the original positions as before
according to the determined procedures.
(2) When removing the cords, do so without
applying unreasonable extra strength.
(3) Take care of the following incase storage is
necessary.
I. Store in a dry place.
II. Store in places where there are no adverse
effects due to atmosphere containing pres-
sure, heat, humidity, air passage, direct
sunlight, dust, salt or sulfur.
III. Do not store in places where chemicals are
stored or where there is generation of
gases.
(4) Align and arrange after cleaning the accesso-
ries, cords, etc.
(5) Always clean the equipment so that there are
no breakdowns when using it again.
6. In case of a breakdown, do not fiddle on your own
discretion,
perform the appropriate display and entrust the
repairing to a technician.
7. Do not modify the equipment.
8. Maintenance check
Always check the equipment and the parts.
When using equipment that has not been used for a
while, confirm that the equipment is operating nor-
mally and safely before reuse it.
9. Others
(1) Operate properly in accordance with the
Instruction Manual.

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Digital radiography system, dental C10819 Series
For Safe Usage
In order to use this Product safely, always read the Instruction Manual before using the product.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in
minor or moderate injury.
It may also be used to alert against unsafe practices.
This symbol means "follow to operating instructions".
Type B Equipment
Legal manufacturer for EU-market
Authorized repersentative in the European Community
CE marking for conformity of 2007/42/EC
0120 — Notified Body No.
SGS United Kingdom Limited
Serial number
CLASSII Equipment
EC REP
0120

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Digital radiography system, dental C10819 Series
Table of contents
1. Overview ............................................................................................................................. 4
2. Purpose and Conditions of Use .......................................................................................... 5
2.1 Purpose of Use .......................................................................................................... 5
2.2 Precautions when using in combination with other Equipments ................................ 5
2.3 Safety ......................................................................................................................... 5
2.4 Labeling ..................................................................................................................... 6
2.5 Other Precautions ...................................................................................................... 7
2.6 Environmental Conditions .......................................................................................... 9
2.7 Power ......................................................................................................................... 9
3. Accessories ....................................................................................................................... 10
4. Description of the External appearance and Various parts ............................................... 11
4.1 Sensor Unit .............................................................................................................. 11
4.2 Main Unit .................................................................................................................. 12
5. Setup ................................................................................................................................. 13
5.1 System Configuration ............................................................................................... 13
5.2 Equipment Connection ............................................................................................. 14
5.3 Driver Installation ..................................................................................................... 15
5.4 Installation of Application software ........................................................................... 21
6. Product Specifications ...................................................................................................... 22
6.1 Specifications ........................................................................................................... 22
6.2 Functions ................................................................................................................. 23
6.3 Data Acquisition Timing Chart ................................................................................. 25
6.4 Dimensions .............................................................................................................. 26
7. Maintenance ..................................................................................................................... 29
7.1 Repair ......................................................................................................................29
7.2 Maintenance (Service life) ....................................................................................... 29
7.3 Cleaning ................................................................................................................... 29
8. Warranty ........................................................................................................................... 30
Appendix-A .............................................................................................................................. 31
Terminology ...................................................................................................................... 31
Appendix-B .............................................................................................................................. 32
Troubleshooting (FAQ) ..................................................................................................... 32

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Digital radiography system, dental C10819 Series
1
Overview
The "Digital radiography system, dental (GMDN code 18053) C10819 series" is an
equipment developed for Intra-oral Radiography.This product consists of a sensor unit
and a main unit. Control and Data transmission can be performed between this product
and PC (Personal Computer) via USB (compliant with USB2.0). Also, since the power
supply of this product is provided by the USB port of the PC, an external power source
is not required. Furthermore, Application software that operates in Windows2000/XP is
included in this product thus it can be operated on a PC right away.
Moreover, Dynamic Link Library (DLL) is also included in the Application software of this
product and the software can be developed.
Sensor Unit
The sensor unit consists of a X-ray scintillator and CCD.
In this product series, the following are the series products according to the type of
the Sensor connected.
• C10819-01 : Main unit + "S10810" (sensor unit)
• C10819-02 : Main unit + "S10811" (sensor unit)
Main Unit
This product/main unit is loaded with various types of Digital Signal Processing Cir-
cuits starting with 12bitADC. This product is also loaded with Sub-array binning
(2X2) function, Gain adjustment function and Offset adjustment function in order to
reduce the image data size and the transmission time.
This product is user-friendly and has these 4 operational modes ("Suspend", "Idle/
Sleep", "Standby", "Data Transfer"). Also, each of the operational modes is sepa-
rated by different displays of main unit LED.
Special Features
• USB Bus powered power supply to the main unit (External power source is not
required).
• 2 types of Industrially Standard Image Sizes (Size1 and Size2) are available.
• High-resolution and Low-cost type are also available.
• Supports AC/DC type X-ray source.
• Acquire digital images on the PC with this product and its exclusive software
only.
• Speedy Data transmission via USB2.0.
• Display of the Operational Modes by LED.
Compliant Standard
This product is designed and manufactured according to the following specifica-
tions.
• IEC60601-1 :2005
• IEC60601-1-2 :2007

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Digital radiography system, dental C10819 Series
2
Purpose and Conditions of Use
2.1 Purpose of Use
This product is intra-oral X-ray imaging unit for Dental Radiography.
The intended purpose of use of the equipment
For intra-oral Radiography (Diagnosis of the Tooth, tissue about the root of a tooth)
Contraindication and Prohibition
Continuous use of the Sensor Cover
*The Sensor Cover is to be used only once.
2.2 Precautions when using in combination with other Equipments
Connected Equipments
Contact the Maker or the Distributor for "Doubts and Queries" related to connection
with equipments other than those mentioned above.
2.3 Safety
Classification with respect to the Protection System/Degree of Protection against elec-
tric shock
Caution
When determining the diagnosis and the treatment of a patient, do
not rely on the data of this product alone and determine in combi-
nation with other clinical indications or data, etc.
Caution
The Equipments (Computer, etc.) used for connecting with this
product must conform to IEC60950-1 and ensure safe voltage iso-
lation.
Please connect the attached USB cable directly to the universal
serial bus port of PC used. (Please do not use the hub.)
While using AC cable of PC, use 3 terminal pin ( with ground ).
If it is not possible then use ground of pc itself.
Protection System against Electric shock ClassII
Degree of Protection against Electric shock B Type
Caution
Do not remove the cover of the sensor unit or the main unit. Dan-
ger of Damage and Electrocution.

Purpose and Conditions of Use
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Digital radiography system, dental C10819 Series
Precautions against Penetration of Liquids
Do not allow any penetration into the main unit.
Precautions against Combustible Environment
Do not use in Combustible Environment (Combustible Gases, High-density Oxygen,
etc.)
2.4 Labeling
The CE mark is a mark which is attached to satisfy the standard of EU member nation.
Sensor unit
The upper surface of sensor unit connector.
Main unit
Base of the main unit.
Caution
Do not allow any penetration of Liquids into the main unit.
Danger of causing main unit malfunctions.
Caution
Do not use in Combustible Environment (Combustible Gases,
High-density Oxygen, etc.)
Risks of causing Fire/Blast.
S10810 S10811

Purpose and Conditions of Use
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Digital radiography system, dental C10819 Series
2.5 Other Precautions
Handling Precautions
Caution
Maintenance and Repair to be performed only by the Maker or by
technicians authorized by the Maker.
Caution
• Do not twist, bend or cut the cables. Can cause damages.
• Connect or disconnect the cables only according to the proce-
dures described in this document. Can cause damages to the
internal circuits.
• Use the cable properly. Excessive tension applied to the cables
can cause malfunctions.
• The cable is fixed on the sensor unit, do not pull. Can cause
damages.
• Do not keep anything on the cable.
• Since the cable is deteriorated by humidity, do not allow any
source of humidity such as damp cloth or spray etc.
• Always use the included USB cables.
• The sensor unit might get damaged due to Static electricity. Do
not touch the Connector pins.
• When the sensor unit is not connected to the main unit, cover
the connectors and keep the pins safe.
• Do not keep anything on the Sensor.
• Do not apply any pressure to the sensor unit. The sensor unit
can get damaged due to the pressure applied (Haemostatic for-
ceps or holders, etc.).
• Do not subject the sensor unit to shocks (Dropping, collision,
etc.).
• Do not apply any substances / fluids.
• Do not sterilize by heating or autoclave.
• During the use, protect the sensor unit by covering it with Sili-
con sleeve or Plastic cover to avoid various infections among
the patients. Silicon sleeve is recommended for acquiring multi-
ple images with respect to a single patient.
• Do not take it apart or perform modifications under any circum-
stances. Can cause malfunctions.

Purpose and Conditions of Use
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Digital radiography system, dental C10819 Series
Regarding disposal
Regarding software
Caution
• Do not subject to excessive shocks (Dropping, collision, etc.).
Can cause Damages or Malfunctions.
• Do not keep anything on the main unit.
• Do not immerse in water, disinfectants or any other chemicals.
Can cause damages or malfunctions.
• Avoid sudden changes in the voltage or irregular current fluctu-
ations. Use of Surge protector (protection against thunder or
excessive voltage) and uninterrupted power supply (UPS) is
recommended including for the Computer system.
• In case of clicking pictures by this product, follow precautions
similar to the precautions for clicking pictures heretofore or
click by the same procedure.
• The person clicking the pictures (Doctor or Technician) must
follow the correct Radiation Hygiene Procedures.
• Please study the method of use of this product before using.
• Please check and confirm that the case, cable etc. are in good
conditions each day before start working.
• Please lightly wipe cloth to 70% isopropyl alcohol and clean it
everyday.
• If ground is not done, and power breakdown or short circuit
occurs then there can be a chance of get shocked.
• If disposable cover is not used, then there can be a chance of
serious injury to health.
Caution
When disposing this product or its consumables (switching of the
Sensor after its endurance time has elapsed, cover, etc.), follow
the local regulations and the recycling procedures related to the
disposal and recycling of electric equipments and components.
Caution
• Please do not start two or more software at the same time when
you use the application.

Purpose and Conditions of Use
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Digital radiography system, dental C10819 Series
2.6 Environmental Conditions
2.7 Power
USB bus powered (Consumption current: 350mA max)
Ambient temperature 0 ºC to 40 ºC (During operation)
Relative humidity Below 70% (During operation)
Caution
Do not store or operate in the following places.
• Places with sharp temperature changes.
• Places with direct sunlight.
• Near heating appliances.
• Near things generating high-intensity magnetism or radio
waves.
• Places with vibrations.
• Places touching corrosive gases (Chlorine, fluorine, etc.)
• Places with dust.

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Digital radiography system, dental C10819 Series
3
Accessories
Sensor Unit................. 1
Main Unit .................... 1
USB Cable.................. 1
Package Insert............ 1
CD .............................. 1
Software Installer
• Driver software for controlling C10819 Signal processing unit
(for Windows 2000/XP)
• Library software for controlling C10819 Signal processing
unit (for Windows 2000/XP)
• Application software for Data measurement (for Windows
2000/XP)
• Various Instruction Manuals
• C10819 Series Instruction Manual
• C10819 Series Application Software Instruction Manual
• DCamLibM.DLL Manual
• DCamImg.DLL Manual

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Digital radiography system, dental C10819 Series
4
Description of the External appearance and Various parts
4.1 Sensor Unit
Sensor
Analog video signal depending on the X-ray radiation intensity and a timing signal
(H-CMOS Logic level signal) that is in synchronization with the X-ray radiation dura-
tion is output through the Connector.
36pin MDR Connector
This is a high-density 36pin MDR for connecting with the main unit. The Bias volt-
age and various Clock signals are provided by the main unit through the connector.
Also, Analog video signal depending on the X-ray radiation intensity and a timing
signal (H-CMOS logic level signal) that is in synchronization with the X-ray radiation
duration is input from the Sensor.
Sensor
Connector (MDR 36pin)
Sensor cable
From the left
S10810
S10811

Description of the External appearance and Various parts
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Digital radiography system, dental C10819 Series
4.2 Main Unit
Sensor Connector
This is a High-density 36pin MDR connector for connecting with the sensor unit
(S10810, S10811).
USB Connector
This is connector for connecting with the PC; Industry-standard USB connectors are
used. The interface is in accordance with USB2.0 specifications. Through this inter-
face, various setups are performed and the X-ray image data that is converted into
digital signals is also transmitted.
Status Display LED
It is a LED which displays the current operational mode of the main unit. The rela-
tion between the display and operational mode are as follows. These are all dis-
played by green.
Refer to "6.2 Functions" and "Operational mode", for details of the various modes.
LED Display Operational Mode
Lights out Suspend Mode
Fast frequency blinking Idle/Sleep Mode
Light on Standby Mode
Low frequency blinking Data Transfer Mode
SENSOR
STATUS
Sensor Connector (MDR 36pin)
Status Display LED
USB Connector

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Digital radiography system, dental C10819 Series
5
Setup
5.1 System Configuration
PC is necessary for using this product.
Following are the recommended specifications.
CPU Intel®Pentium®4 Above 2.6GHz
Intel®Pentium®M Above 1.4GHz
RAM Above 512MB
HDD Above 3MB
However, it is the required space at the time of software installation
and may change depending on the usage status.
CD-ROM Drive Used at the time of software installation.
I/F USB2.0 × 1
Display XGA above (1024 × 768)
OS Microsoft®Windows®2000(SP4 or later)/XP(SP1 or later)

Setup
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Digital radiography system, dental C10819 Series
5.2 Equipment Connection
Connect each of the equipment by referring to the following procedure.
1. Connect the "36pin MDR connector" of the sensor unit to the "SENSOR connector"
of the main unit.
2. Connect "B connector" of the USB cable to the "USB connector" of the main unit.
3. Connect the "A connector" of the USB cable to the "USB port" of the PC.
1
23

Setup
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Digital radiography system, dental C10819 Series
5.3 Driver Installation
In order to make this product usable on a PC, installation of software called "Device
Driver" is necessary.
The installation method of this software varies slightly depending on the OS.
Install the "Device Driver" by referring to the following installation methods based on the
OS.
For Windows2000®
1. When PC is started after the completion of "5.2 Equipment connection", the screen
of the detection of "New hardware" is displayed and "Found New Hardware Wizard"
appears and then click "Next".

Setup
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Digital radiography system, dental C10819 Series
2. In the "Install Hardware Device Drivers" window, confirm that "HPK C10819"is dis-
played in "This wizard will complete the installation for this device", click the radio
button for "Search for a suitable driver for my device (recommended)" and then click
"Next".
3. In the "Locate Driver Files" window, insert the CD in the CD-ROM drive, select the
check box of "CD-ROM drives" and click "Next".

Setup
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Digital radiography system, dental C10819 Series
4. In the "Driver Files Search Results" window, verify that "HPK C10819" and "usb-
camif.inf" is shown in the location of the driver, then click "Next".
5. After the necessary files are copied, confirm the "Completing the Found New Hard-
ware Wizard" and "HAMAMATSU USB Camera Module" screens and then click
"Finish". With this the driver installation is complete.

Setup
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Digital radiography system, dental C10819 Series
6. After the installation is complete, right-click on "My computer" and select "Proper-
ties". The "system properties" will be displayed, refer the "Device Manager" in the
"Hardware" tab and confirm that "HAMAMATSU USB Camera Module" is displayed.

Setup
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Digital radiography system, dental C10819 Series
For WindowsXP®
1. When PC is started after the completion of "5.2 Equipment connection "Found New
Hardware Wizard" is started, confirm that "HPK C10819" is displayed, click the radio
button for "Install from a list or specific location (Advanced)" and click "Next".
2. In the "Please choose your search and installation options" window, click the radio
button for "Search for the best driver in these locations", select the checkbox for
"Search removable media (floppy, CD-ROM...)" and click "Next".