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