Dexcowin iRayD3 User manual

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Manual Version: V2020.7

TABLE OF CONTENTS
1IRAYD3(DX3000) ......................................................................... 5
1.1 NOTICE............................................................................................... 5
1.2 INTRODUCTION ..................................................................................... 6
1.2.1 Intended use......................................................................................................7
1.2.2 Contraindication ................................................................................................7
1.3 SYMBOLS USED IN THIS MANUAL ............................................................. 8
1.4 SYMBOLS MARKED ON DX3000 .............................................................. 9
1.5 SYMBOLS MARKED ON THE PACKAGING OF DX3000 ................................. 10
1.6 LABELING LOCATION ............................................................................ 11
1.6.1 Outside ............................................................................................................11
1.6.2 Inside: X-ray tube assembly ............................................................................11
2WARNING AND INSTRUCTIONS............................................ 12
2.1 SYMBOLS AND DETAILS......................................................................... 12
2.2 WARNING FOR USE.............................................................................. 12
2.2.1 Warning for product use.................................................................................12
2.2.2 Warnings for battery use ................................................................................13
2.2.3 Caution for product inspection.......................................................................13
2.3 WARNINGS FOR STORAGE ..................................................................... 14
3CAUTION AND INSTRUCTIONS ............................................. 15
3.1 SYMBOLS AND DETAILS......................................................................... 15
3.2 CAUTION AND INSTRUCTIONS................................................................ 15
3.2.1 Caution for product storage ...........................................................................15
3.2.2 Caution for product use..................................................................................15
3.3 CAUTION OF OTHER MATTERS................................................................ 16

4ITEMS TO CHECK ...................................................................... 17
4.1 SYMBOL AND DETAIL ........................................................................... 17
4.2 ITEMS TO CHECK ................................................................................. 17
5PRODUCT FEATURES ................................................................ 18
5.1 OUTLINE............................................................................................ 18
5.2 PRODUCT FEATURES ............................................................................ 18
5.2.1 Features ...........................................................................................................18
5.3 PRODUCT SPECIFICATIONS..................................................................... 19
5.3.1 Device main body ...........................................................................................19
5.3.2 Battery Pack.....................................................................................................19
5.3.3 Battery pack charging adapter........................................................................20
5.3.4 Battery charging cradle ...................................................................................20
6PRODUCT COMPOSITION ....................................................... 21
6.1 OUTLINE............................................................................................ 21
6.2 PRODUCT COMPOSITION....................................................................... 21
6.3 PRODUCT EXPLANATION....................................................................... 23
6.3.1 Main body name .............................................................................................23
6.3.2 UI screen composition and functions .............................................................24
6.3.3 Each part of the buttons and functions..........................................................26
6.3.4 Name for each part on battery pack and charging devices ..........................29
7HOW TO USE ............................................................................. 32
7.1 POWER ON/OFF................................................................................. 32
7.2 X-RAY EXPOSURE POSITIONING............................................................. 33
7.2.1 Patient’s positioning........................................................................................33
7.2.2 Film or intraoral sensor positioning................................................................34
7.2.3 DX3000 positioning.........................................................................................35

7.3 X-RAY EXPOSURE ............................................................................... 35
7.3.1 X-RAY exposure sequence ..............................................................................35
7.3.2 X-RAY Exposure time set ................................................................................37
7.4 ENVIRONMENT SETUP........................................................................... 40
7.4.1 Environment setup screen...............................................................................40
7.4.2 Environment setup list.....................................................................................40
7.5 WIRED REMOTE CONTROLLER ................................................................ 42
7.5.1 Wired remote controller usage.......................................................................42
7.6 BACK SCATTERED SHIELD....................................................................... 43
7.6.1 Mounting back scattered shield with Main body...........................................43
7.6.2 Performance of back scattered shield ............................................................44
7.7 BATTERY ............................................................................................ 45
7.7.1 Mounting battery inside Main body...............................................................45
7.7.2 Battery level and charging ..............................................................................46
7.8 APPLICATION SPECIFICATION.................................................................. 50
7.8.1 Intended medical indication............................................................................50
7.8.2 Intended patient population...........................................................................50
7.8.3 Intended user profile.......................................................................................51
8MAINTENANCE AND STORAGE METHOD ........................... 52
8.1 MAINTENANCE AND STORAGE ............................................................... 52
8.2 CLEANING PROCEDURE ......................................................................... 53
8.2.1 Check for Product storage ..............................................................................53
8.3 STORAGE METHOD............................................................................... 53
8.3.1 Check for Product storage ..............................................................................53
8.3.2 Charging adaptor and cradle storage.............................................................54
8.4 PRODUCT TRANSPORTATION,STORAGE CONDITIONS AND CONDITIONS OF USE 54
8.4.1 Transportation and storage conditions ..........................................................54
8.4.2 Optimal conditions of use...............................................................................54

8.5 MAINTENANCE SCHEDULE..................................................................... 55
8.5.1 On-going Check ..............................................................................................55
8.5.2 Annual User Check ..........................................................................................56
8.5.3 Annual Calibration...........................................................................................57
8.5.4 Maintenance Log Sheet ..................................................................................58
9INSPECTION ITEMS BEFORE REPAIR REQUEST................... 59
9.1 CHECK ITEMS BEFORE REQUESTING INSPECTION ......................................... 59
9.2 TROUBLESHOOTING ............................................................................. 61
10 PRODUCT SPECIFICATION AND PRODUCT WARRANTY .. 62
10.1 PRODUCT SPECIFICATION...................................................................... 62
10.2 PRODUCT WARRANTY........................................................................... 63
11 IRAY D3(DX3000)TECHNICAL DOCUMENT.......................... 64
11.1 HIGH VOLTAGE GENERATOR................................................................... 64
11.1.1 X-RAY Tube: D-081B .......................................................................................64
11.2 ELECTROMAGNETIC COMPATIBILITY ......................................................... 66
11.2.1 Electromagnetic Interference ..........................................................................68
11.3 RADIATION PROTECTION ...................................................................... 69
11.4 NOMINAL RADIATION OUTPUT ............................................................... 69
11.5 DOSE AREA PRODUCT........................................................................... 71
11.6 LEAKAGE RADIATION............................................................................ 73
11.6.1 Measurement in 1[m] from focal spot............................................................73
11.6.2 Measurement in 1[cm] from case surface ......................................................74
11.7 STRAY RADIATION ............................................................................... 77
11.7.1 Set the significant zone of occupancy............................................................77
11.7.2 Test method and result of stray radiation......................................................78
11.7.3 Stay radiation with back scattered shield application....................................81

1iRayD3(DX3000)
1.1 Notice
DX3000 is a Portable Handheld Dental X-RAY System.
This is a diagnostic device that has been developed to not only take radiographs
analogically, using a conventional film, but also be used in Dental Digital
Radiograph (DDR) using digital sensor as well.
This manual contains instructions, procedures, technical drawings and
description for DX3000. Do not operate this device until you have read and
reviewed this accompanying user manual completely.
DX3000 is a trademark registered by Dexcowin Co., Ltd in Korea and other
countries.
For further information not covered in this manual and any incidents concerning
the device, please report it to the manufacturer at:
DEXCOWIN CO., LTD.
Email: [email protected]
Phone: [phone]
Fax: [phone]
Model: DX3000
Version: 2020.7
Country: EU (EN)
Initial Date: 07-30-2005
Rev. Date: 12-15-2021

1.2 Introduction
Thank you for purchasing the portable X-ray system of DEXCOWIN. DX3000 has been
so developed as to not only take radiographs in analog way using conventional film,
but also be used in Dental Digital Radiograph, DDR using digital sensor as well. Please
use following requirement for application.
Please follow product use instructions in using this product.
CAUTION
For proper usage and safety purposes, please ensure that only legally qualified
person (Doctor, Medical Treatment Radiological Technologist, Medical
Treatment X-RAY Technologist) can use this product after fully familiarize with
contents of user manual.
PRODUCT USAGE
This product is a medical device, and it should only be used as digital X-ray
radiography device for X-ray radiography at corresponding hospitals.
TYPE B Applied Part
Type B Applied Part provide the lowest degree of patient protection of all the
types of applied part and are not suitable for direct cardiac application.
WARNING
This X-ray unit may be dangerous to patient and operator unless safe exposure
factors, operating instructions and maintenance schedules are observed.

1.2.1 Intended use
DX3000 is intended to be used for producing diagnostic dental radiographs for
treatment of disease of the teeth. It consists of a battery-operated, compact size,
battery charging adapter and battery charging cradle. Its function is to acquire
dental x-ray image by using conventional film or digital sensors. It is used by
dentists or qualified and authorized physicians in hospitals.
It is used by dentists or qualified and authorized physicians in hospitals.
1.2.2 Contraindication
The DX3000 are contraindicated for use on patients who known to be or possibly
pregnant.

1.3 Symbols used in this Manual
SYMBOL
NAME
DETAIL
Radiation
warning
“Radiation Warning”sign explains details of
possible user radiation hazard.
Warning
"Warning" sign explains details of possible user
damage, death or physical damage.
Caution
"Caution" sign explains details of possible body
damage due to incorrect use of product.
Check
"Check" sign explains details of necessarily items
that users should follow in product installation,
oepration, and maintenance.

1.4 Symbols marked on DX3000
SYMBOL
NAME
DESCRIPTION / FUNCTION
Electrical protection
Insulated patient application(Type B).
Radiation warning
This symbol indicates radiation hazard.
Warning
This symbol indicates hazard.
Consult
accompanying
documents
This symbol advises the reader to consult the
accompanying documents.
Manufacturer
information
This symbol is followed by the name and
address of the device manufacturer.
Manufacture date
This symbol is followed by the device
manufacture date in the form YYYY-MM.
Serial number
This symbol is followed by the device serial
number.
Representatives
information
The manufacturer’s EU representative
information shows with this symbol.
CE Mark
This symbol indicates CE certification

Separate collection
for electrical and
electronic equipment
Indicates the need for separate collection for
electrical and electronic equipment in
compliance with the Waste Electrical and
Electronic Equipment (WEEE) Directive. This
symbol indicates that electrical and electronic
equipment wastes must not be disposed as
unsorted municipal waste and must be collected
separately. Please contact the manufacturer or
an authorized disposal company to
decommission your equipment according to
local regulations
1.5 Symbols marked on the packaging of DX3000
SYMBOL
NAME
DESCRIPTION / FUNCTION
Keep away from rain
This symbol means that transport package shall
be kept away from rain.
Fragile
This symbol means that contents of the
transport package are fragile therefore it shall
be handled with care.
This way up
This symbol means that indicates correct upright
position of the transport package.

1.6 Labeling location
1.6.1 Outside
1.6.2 Inside: X-ray tube assembly
Figure 1.1 Labeling on X-ray tube assembly

2Warning and instructions
2.1 Symbols and details
"Warning" sign explains details of possible user damage, death or physical
damage.
“Warning”means potential danger, in order to avoid serious personal injury
or death.
2.2 Warning for use
2.2.1 Warning for product use
Do not modify the device without authorization of the manufacturer.
Please ensure not to exceed X-RAY exposure dose required for image diagnosis.
Do not modify the device without authorization of the manufacturer.
When using device, if radiation exposure safety regulations and operation related
guidelines are not followed, both patients and operators can be at risk.
Only legally qualified personnel can operate this device.
Please use this device only for designated purpose.
When using this device, if any abnormalities are found with the patients, please
stop using the device, and ensure the safety of patients.
Please do not randomly alter the device while using.

While using, if you suspect of breakdowns such as oil leakage, please turn off
power immediately, and contact the closest customer support center.
Make sure fire extinguisher is onsite for fire emergency.
When patients with a pacemaker are in radiograph successively, could result in
malfunction of the pacemaker.
2.2.2 Warnings for battery use
If non-standard batteries are used, there is danger of battery explosion.
Avoid strong shocks to batteries and avoid penetration to batteries with sharp
objects.
If batteries are kept under high temperature, there is danger of battery explosion.
Do not make batteries wet or let batteries exposed in water or liquids.
Keep and store batteries away from children and pets.
Please do not put metallic substance to battery terminals or disassemble as it may
cause explosion.
Please do not let charge terminals come into contact with metallic substance.
2.2.3 Caution for product inspection
Do not touch product, charger, and power plug with wet hands, otherwise, there is
danger of getting electrical shocks.
During cleaning process of product, do not use wet wiping clothes, or spray. Also,
please only do cleaning after separating batteries from device.

2.3 Warnings for storage
Moisture, salinity, dust, and etc. can affect the performance of device, therefore, do not
store device in places with such conditions.
Do not store product in places with frequent temperature changes or direct sunlight for
long period of time. Under the circumstance of too low or high temperature, high
voltage generator’s cooling and insulating oil could be shrunk or swollen or frozen or
overheat and it may cause critical damages to the device functions.
Do not store product together with explosive gas or chemicals.
Do not leave battery pack connected with charger during storage. When battery keeps
being discharged or charged too long, it may shorten battery lifespan or cause danger
of explosion.
The device must be stored in protection case. When being damaged physically at
unsafe place, it may cause critical damages to the device functions.
Do not place the device on high shelf or any narrow place. It may cause harm to user
or damage to itself by falling down.
Do not store the device at trunk of car or at cargo van of truck which delivers negative
impact while moving. In case of storing it in those places, please make sure the
protection is kept very tightly.

3Caution and instructions
3.1 Symbols and details
"Caution" sign explains details of possible body damage due to incorrect use
of product.
3.2 Caution and instructions
3.2.1 Caution for product storage
Moisture, salinity, dust, and etc. can affect the performance of device, therefore, do
not store device in places with such conditions.
Do not store product in places with frequent temperature changes or direct
sunlight for long period of time.
Do not store product together with explosive gas or chemicals.
Do not leave battery pack connected with charger during storage.
3.2.2 Caution for product use
Please maintain regular temperature and moisture level for normal operation.
During using or transporting the device, please be careful to avoid severe shocks or
vibration.

Please wear apron protected with lead or equivalent radiation protection gear.
Please do not put in dusty, dirty, or tilted place while using.
Do not pull out connection cable of battery pack cradle and charger unreasonably
since it can become cause of breakdown.
3.3 Caution of other matters
In case of device breakdown, mark properly and be sure to leave it to designated
professional at A/S center.
Do not let patients touch the device randomly, and keep it away from patients' hands.
When dropping the device, do not turn it on and detach battery and raise an inquiry
to seller or manufacturer for checking.
When discarding product,
Indicate the need for separate collection for electrical and electronic
equipment in compliance with the Waste Electrical and Electronic Equipment
(WEEE) Directive. This symbol indicates that electrical and electronic
equipment wastes must not be disposed as unsorted municipal waste and
must be collected separately. Please contact the manufacturer or an
authorized disposal company to decommission your equipment according to
local regulations
Warning: If any serious incident in relation to the device, Please contact by fax
or e-mail to European representative or Dexcowin CO., LTD. or the local
authority.

4Items to check
4.1 Symbol and Detail
"Check"sign explains details of items that must be followed for product installation,
operation, and maintenance.
4.2 Items to Check
Please check battery pack and device condition, and confirm device operates
accurately before using.
Please ensure to double check the part that directly makes contact with patients.
Please use device with designated sequence.
Please use device at stable place with good ventilation.
Check display lamp of remaining battery power, and if remaining battery power is not
sufficient, please recharge the battery.
Please use exclusive charger only when charging battery pack.
Be sure not to let metallic products and other foreign substance touch battery pack
terminal, and keep it clean by using dry clothes.
Be sure to use device and parts after receiving regular inspection.

5Product Features
5.1 Outline
In Chapter 5, features and specifications of this device are explained for safe use.
5.2 Product Features
5.2.1 Features
○
1Medical Device Name: Portable X-RAY System
○
2Model Name: DX3000
○
3Product Name: iRay D3
○
4Display: 2.35”LCD (Resolution: 128 x 64)
- Exposure time setup by adult and child
- Remaining of battery
- Exposure time setup by part of the teeth
○
5Function for user
- Initial exposure time setting
- Maximum exposure time setting
- Exposure time unit setting
- Single wired remote controller operation and selection of exposure button use
- Automatic power disconnecting time setup
○
6Detachable battery application and extra battery supply as default.

5.3 Product specifications
5.3.1 Device main body
○
1Device Name: Portable X-RAY System
○
2Tube voltage: 60 [kV] (Fixed)
○
3Tube current: 2 [mA] (Fixed)
○
4X-RAY tube focal spot size: 0.8 [mm]
○
5Power consumption: 240 [VA]
○
6Cooling method: OIL Cooling Method
○
7Total Filtration: Over 2.3 [mmAl] (inherent filtration: 0.8 [mmAl])
○
8Target Angle: 20˚
○
9Time setting function: 0.05 –1.35 [sec]
○
10 Distance to target: Distance between target and Focal Spot > 10 [cm]
○
11 Main body size: 139(D) x 164.3(W) x 65(H) [mm]
○
12 Main body weight: 2.3 [kg] (exclusion battery), 2.43 [kg] (Inclusion battery)
5.3.2 Battery Pack
Model name: PF435060HP-4S
Cell material: Lithium Polymer
Charging condition
-Charging current: 1.0 [A]