Dexcowin iRayA6s User manual

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TABLE OF CONTENTS
1iRayA6s ........................................................................................................5
1.1 INTRODUCTION ..................................................................................... 5
1.1.1 Indication for use ..............................................................................................5
1.1.2 Prescription-use statement ...............................................................................6
1.1.3 Contraindication ................................................................................................6
1.2 SYMBOLS USED IN THIS MANUAL .............................................................. 7
1.3 SYMBOLS MARKED ON iRayA6s ............................................................. 8
1.4 SYMBOLS MARKED ON THE PACKAGING OF iRayA6s................................... 9
2WARNING AND INSTRUCTIONS...........................................................10
2.1 SYMBOLS AND DETAILS ......................................................................... 10
2.2 WARNING FOR USE.............................................................................. 10
2.2.1 Warning for product use.................................................................................10
2.2.2 Warnings for battery use ................................................................................11
2.2.3 Caution for product inspection.......................................................................11
2.3 WARNINGS FOR STORAGE ..................................................................... 12
3CAUTION AND INSTRUCTIONS.............................................................13
3.1 SYMBOLS AND DETAILS ......................................................................... 13
3.2 CAUTION AND INSTRUCTIONS ................................................................ 13
3.2.1 Caution for product storage ...........................................................................13
3.2.2 Caution for product use..................................................................................13
3.3CAUTION OF OTHER MATTERS ................................................................ 14
4ITEMS TO CHECK .....................................................................................15
4.1 SYMBOL AND DETAIL ........................................................................... 15
4.2 ITEMS TO CHECK ................................................................................. 15

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5PRODUCT FEATURES ...............................................................................16
5.1 OUTLINE............................................................................................ 16
5.2 PRODUCT FEATURES............................................................................. 16
5.2.1 Features ...........................................................................................................16
5.3 PRODUCT SPECIFICATIONS ..................................................................... 17
5.3.1 Device main body ...........................................................................................17
5.3.2 Battery Pack.....................................................................................................17
5.3.3 Battery pack charging adapter........................................................................18
6PRODUCT COMPOSITION ......................................................................19
6.1 OUTLINE............................................................................................ 19
6.2 PRODUCT COMPOSITION....................................................................... 19
6.3 PRODUCT EXPLANATION ....................................................................... 21
6.3.1 Description of main body ...............................................................................21
6.3.2 Radiation field name .......................................................................................22
6.3.3 GUI screen composition and functions...........................................................23
7HOW TO USE ............................................................................................24
7.1 POWER ON/OFF ................................................................................. 24
7.2 X-RAY RADIOGRAPHY........................................................................... 26
7.2.1 X-RAY exposure intensity setting ....................................................................26
7.2.2 X-RAY tube curren setting...............................................................................27
7.2.3 X-RAY exposure time setting ..........................................................................28
7.2.4 Memory setting function ................................................................................29
7.2.5 X-RAY exposure ...............................................................................................31
7.2.6 Relation between X-ray generating time........................................................35
7.3 ENVIRONMENT SETTING........................................................................ 37
7.3.1 Environment setting panel ..............................................................................37
7.4 WIRED REMOTE CONTROLLER................................................................. 38

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7.4.1 Wired remote control usage ...........................................................................38
7.5 BATTERY ............................................................................................ 39
7.5.1 Mounting battery on Main body....................................................................39
7.5.2 Battery level and charging ..............................................................................40
7.6 SSD CAGE ......................................................................................... 44
7.6.1 SSD cage .........................................................................................................44
7.6.2 How to assemble.............................................................................................45
8MAINTENANCE AND STORAGE METHOD AND REPAIR...................46
8.1 MAINTENANCE AND STORAGE................................................................ 46
8.2 STORAGE METHOD............................................................................... 46
8.2.1 Check for product storage ..............................................................................46
8.2.2 Charger adaptor storage.................................................................................47
8.3 MAINTENANCE SCHEDULE..................................................................... 48
8.3.1 On-going Maintenance ...................................................................................48
8.3.2 Annual User Check........................................................................................49
8.3.3 Annual (Optional) Calibration .........................................................................50
8.3.4 Maintenance Log Sheets.................................................................................52
8.4 REPAIR .............................................................................................. 53
9INSPECTION ITEMS BEFORE REPAIR REQUEST ..................................54
9.1 CONFIRM ITEMS BEFORE REQUESTING INSPECTION..................................... 54
10 PRODUCT SPECIFICATION AND PRODUCT WARRANTY ..................56
10.1 PRODUCT SPECIFICATION ...................................................................... 56
10.2 PRODUCT WARRANTY .......................................................................... 57
11 iRayA6s(ADX6000s) TECHNICAL DOCUMENT ....................................58
11.1 HIGH VOLTAGE GENERATOR................................................................... 58
11.1.1 X-RAY Tube: D-0813B ......................................................................................58

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11.2 ELECTROMAGNETIC COMPATIBILITY .......................................................... 61
11.3 PRODUCT TRANSPORTATION,STORAGE CONDITIONS AND CONDITIONS OF USE 62
11.3.1 Transportation and storage conditions...........................................................62
11.3.2 Optimal conditions of use...............................................................................62
11.4 LABEL................................................................................................ 62
11.4.1 Product label ...................................................................................................62
11.4.2 High Voltage Tank (X-ray generator) label .....................................................63
11.4.3 Warning label ..................................................................................................63
11.5 RADIATION PROTECTION ....................................................................... 64
11.6 TECHNIQUE CHART .............................................................................. 66
11.6.1 Adult technique chart .....................................................................................66
11.6.2 Pediatric technique chart ................................................................................76
11.6.3 Dose value chart..............................................................................................86
11.6.4 Dose area product chart .................................................................................93
11.7 LEAKAGE RADIATION .......................................................................... 101
11.7.1 Measurement in 1[m] from focal spot..........................................................101
11.7.2 Measurement in 1[cm] from case surface ....................................................102
11.8 STRAYED RADIATION .......................................................................... 105
11.8.1 Set the significant zone of occupancy..........................................................105
11.8.2 Test method and result of stray radiation ....................................................106

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1iRayA6s
1.1 Introduction
Thank you for choosing Dexcowin's Portable X-RAY device, iRayA6s (Model Name:
ADX6000s) digital X-RAY device (Digital Radiography System). iRayA6s is diagnosis
device that can be used on pediatric and adult patients, this device is designed for
taking diagnostic X-rays of extremities.
iRayA6s has different strong, user friendly features as follows.
A 4.3-inch touch pad TFT-LCD screen
The Graphic User Interface (GUI) is designed intuitive for easy operation.
We recommend that you should read this manual carefully prior to using the device.
To keep the usage guideline helps the user and also the patient reduce potential risk
during usage.
1.1.1 Indication for use
The iRayA6s (ADX6000s) is handheld and portable general purpose X-ray system.
The device uses a variable tube current with voltage from 50-80kVp and, therefore,
is limited to taking diagnostic x-rays of extremities.
This device is not intended for mammography.
It is intended to be used by a qualified and trained clinician on both adult and
pediatric patients.
WARNING
The iRayA6s (ADX6000s) is not intended to replace a radiographic system with
a wide range of tube current and voltage (kVp), which may be required for full
optimization of image quality and radiation exposure for different expose types.

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1.1.2 Prescription-use statement
 Caution : Federal law restricts this device to sale by or on the order of a physician
or other properly licensed health care professionals. Device is for prescription use
only.
1.1.3 Contraindication
The iRayA6s should not be used on patients that are pregnant or could possibly be
pregnant.
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 Portable X-RAY
radiograph device for X-ray radiography.
WARNING
This X-
ray unit may be dangerous to patient and operator unless safe exposure
factors, operating instructions and maintenance schedules are observed.

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1.2 Symbols used in this manual
SYMBOL NAME DETAIL
Radiation
warning
“Radiation Warning” sign explains details of possible
user radiation hazard.
Warning "Warning" alerts the operator that
failure to follow the
procedure could cause bodily injury or death..
Caution
"Caution"
alerts the operator that failure to folow the
procedure could cause damage to the equipment of
cause loss of data.
Check
"Check" sign explains
the items that you should
comply with upon installation, operation, repair and
maintenance of the product.

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1.3 Symbols marked on iRayA6s

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1.4 Symbols marked on the packaging of iRayA6s
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 withcare.
This way up This symbol means that indicates correct upright
position of the transport package.