ImageWorks IRayD3 Manuale utente

USER Manual

TABLE OF CONTENTS

1IRAYD3(DX3000) ......................................................................... 6

1.1 INTRODUCTION ..................................................................................... 6

1.1.1 Intended use......................................................................................................7

1.1.2 Contraindication ................................................................................................7

1.2 SYMBOLS USED IN THIS MANUAL ............................................................. 8

1.3 SYMBOLS MARKED ON IRAYD3................................................................ 9

1.4 SYMBOLS MARKED ON THE PACKAGING OF IRAYD3................................... 10

1.5 LABELING LOCATION ............................................................................ 11

1.5.1 Outside ............................................................................................................11

1.5.2 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 ..................................................................... 13

3CAUTION AND INSTRUCTIONS ............................................. 14

3.1SYMBOLS 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

USER Manual

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..................................................................... 18

5.3.1 Device main body ...........................................................................................18

5.3.2 Battery Pack.....................................................................................................19

5.3.3 Battery pack charging adapter........................................................................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 ..........................28

7HOW TO USE ............................................................................. 30

7.1 POWER ON/OFF ................................................................................. 30

7.2 X-RAY EXPOSURE POSITIONING ............................................................. 31

7.2.1 object’s positioning .........................................................................................31

7.2.2 Film or intraoral sensor positioning................................................................32

7.2.3 iRayD3 positioning ..........................................................................................32

USER Manual

7.3 X-RAY EXPOSURE ............................................................................... 33

7.3.1 X-RAY exposure sequence ..............................................................................33

7.3.2 X-RAY Exposure time set ................................................................................34

7.4 ENVIRONMENT SETUP........................................................................... 36

7.4.1 Environment setup screen...............................................................................36

7.4.2 Environment setup list.....................................................................................36

7.5 WIRED REMOTE CONTROLLER ................................................................ 38

7.5.1 Wired remote controller usage.......................................................................38

7.6 BACK SCATTERED SHIELD....................................................................... 39

7.6.1 Mounting back scattered shield with Main body...........................................39

7.6.2 Performance of back scattered shield ............................................................40

7.7 BATTERY ............................................................................................ 42

7.7.1 Mounting battery inside Main body...............................................................42

7.8 BATTERY LEVEL AND CHARGING.............................................................. 43

7.9 APPLICATION SPECIFICATION.................................................................. 47

7.9.1 Intended medical indication............................................................................47

7.9.2 Intended object animal ...................................................................................47

7.9.3 Intended user profile.......................................................................................47

8MAINTENANCE AND STORAGE METHOD ........................... 49

8.1 MAINTENANCE AND STORAGE ............................................................... 49

8.2 CLEANING PROCEDURE ......................................................................... 50

8.2.1 Check for Product storage ..............................................................................50

8.3 STORAGE METHOD............................................................................... 50

8.3.1 Check for Product storage ..............................................................................50

8.3.2 Charging adaptor store...................................................................................51

8.4 PRODUCT TRANSPORTATION,STORAGE CONDITIONS AND CONDITIONS OF USE 51

8.4.1 Transportation and storage conditions ..........................................................51

8.4.2 Optimal conditions of use...............................................................................51

USER Manual

8.5 MAINTENANCE SCHEDULE..................................................................... 52

8.5.1 On-going Check ..............................................................................................52

8.5.2 Annual User Check ..........................................................................................53

8.5.3Annual Calibration...........................................................................................54

8.5.4 Maintenance Log Sheet ..................................................................................55

9INSPECTION ITEMS BEFORE REPAIR REQUEST................... 56

9.1 CHECK ITEMS BEFORE REQUESTING INSPECTION ......................................... 56

9.2 TROUBLESHOOTING ............................................................................. 58

10 PRODUCT SPECIFICATION AND PRODUCT WARRANTY .. 59

10.1 PRODUCT SPECIFICATION...................................................................... 59

10.2 PRODUCT WARRANTY .......................................................................... 60

11 IRAYD3(DX3000)TECHNICAL DOCUMENT ........................... 61

11.1 HIGH VOLTAGE GENERATOR................................................................... 61

11.1.1 X-RAY Tube: D-081B .......................................................................................61

11.2 ELECTROMAGNETIC COMPATIBILITY ......................................................... 63

11.2.1 Electromagnetic Interference ..........................................................................65

11.3 RADIATION PROTECTION ...................................................................... 66

11.4 NOMINAL RADIATION OUTPUT ............................................................... 66

11.5 DOSE AREA PRODUCT........................................................................... 68

11.6 LEAKAGE RADIATION............................................................................ 70

11.6.1 Measurement in 1[m] from focal spot............................................................70

11.6.2 Measurement in 1[cm] from case surface ......................................................71

11.7 STRAY RADIATION ............................................................................... 73

11.7.1 Set the significant zone of occupancy............................................................74

11.7.2 Test method and result of stray radiation......................................................75

11.7.3 Stay radiation with back scattered shield application....................................78

USER Manual

MANUAL VERSION 4V10203_A

Revision date: 2019. 03. 01

Commented [U1]: Rev3

4V10203_A [2019. 03. 01]

- 전원 버튼 Silicon cap 적용

- 라벨 및제품 크기 변경

USER Manual

1iRayD3(DX3000)

1.1 Introduction

Thank you for purchasing the portable X-ray system of DEXCOWIN. iRayD3 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 object 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 object and operator unless safe exposure

factors, operating instructions and maintenance schedules are observed.

USER Manual

1.1.1 Intended use

iRayD3 is intended to be used for producing diagnostic dental radiographs for

treatment of disease of the animal teeth. It consists of a battery-operated, compact

size, battery charging adapter. 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.

1.1.2 Contraindication

The iRayD3 are contraindicated for use on objects who known to be or possibly

pregnant.

USER Manual

1.2 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.

USER Manual

1.3 Symbols marked on iRayD3

SYMBOL NAME DESCRIPTION / FUNCTION

Electrical protection Insulated object 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.

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

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