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.

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2Warning and instructions
2.1 Symbols and details
"Warning" sign explains details of possible user damage, death or physical
damage.
2.2 Warning for use
2.2.1 Warning for product use
Do not exceed X-RAY exposure dose required for image diagnosis.
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 to ensure the safety of your patients.
Do not randomly alter the device while using.
WARNING
This X-ray unit must be operated by trained personnel in a controlled setting.

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If you suspect any malfunctions such as oil leakage, please turn off power
immediately, and contact the closest customer support center.
2.2.2 Warnings for battery use
If non-standard batteries are used, there will be a danger of product breakdown.
Avoid strong shocks to batteries and avoid puncturing batteries with sharp objects.
If batteries are kept under high temperature, there is danger of battery damage.
Do not allow batteries to get wet or place in water.
Keep and store batteries away from children and pets.
Please do not disassemble as it may cause the battery damage.
2.2.3 Caution for product inspection
Do not touch product, charger, and power plug with wet hands, to avoid danger of
electrical shocks.
During cleaning process first remove the battery from the device. Use only a dry
cloth to clean the device.

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2.3 Warnings for storage
Do not store device in a damp, dusty or corrosive environment, such conditions will
cause damage to this device.
Do not store device with frequent temperature changes or direct sunlight for long
periods of time.
Do not store device with explosive gas or chemicals.
Do not leave battery pack connected with charger during storage.
Do not leave battery pack connected with main device.
The iRayA6s must be kept in a secure location (such as a locked cabinet) when not in
use in order to prevent unauthorized access.
When finished with the iRayA6s for the day, detach the extermal battery and lock it
away in a separate location to prevent unauthorized use. This practice serves as a
security method for your device.
Another security method is the automatic power shut off feature. The iRayA6s
automatically shuts off if not in use after set time. The operator must press the power
button for one second, then the device turns on and you hear a beeping sound (the
operating system boots up), then the manufacturer’s logo shows up on the device to
let you know it is ready for operation.

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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
Do not store device in a damp, dusty or corrosive environment, such conditions will
cause damage to this device.
Do not store device with frequent temperature changes or direct sunlight for long
periods of time.
Do not store product together with explosive gas or chemicals.
Do not leave battery pack connected with device or charger during storage.
3.2.2 Caution for product use
Pay attention to operating temperature (10-30°C) and humidity (30-60%) level for
normal operation.
When transporting the device, be careful to avoid severe shocks or vibration.
Wear lead apron or equivalent radiation protection gear.
Do not use device in dusty, dirty, or corrosive environment.

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Do not pull cable from battery pack cradle and charger unreasonably since it could
cause failure of the device.

Caution: Federal law restricts this device to sale by or on the order of a licensed
healthcare professional.
3.3 Caution of other matters
In case of device malfunctions, contact your designated A/S center and you will be
given directions for return.
This device should not be handled by any patients. Make sure it is never left
unattended in the patient’s area.
When discarding product,
This symbol indicates the need for separate collection for electrical and
electronic equipment in compliance with the Waste Electrical and Electronic
Equipment (WEEE) Directive. This also 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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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
Check the battery and device to confirm device operates accurately before using.
Check area of device that may come in direct contact with patients.
Be sure to use the device in proper sequence of operation.
Use device in a stable environment with proper ventilation.
Make sure the battery is properly charged, and if remaining battery power is not
sufficient, please recharge the batter y.
The supplied charger is to be used exclusively with this device. Do not use this
charger for any other device.
Make sure the device does not come into contact with metal objects or that other
foreign substances touch battery pack terminal. Keep battery clean by using a dry
cloth.
Be sure to inspect device and parts on a routine basis.

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5Product Features
5.1 Outline
In Chapter 5, features and specifications of this device are explained for safe operation.
5.2 Product Features
5.2.1 Features
①Medical Device Name: Portable X-RAY Radiography Device
②Model Name: ADX6000s
③Product Name: iRayA6s
④Display: 4.3”Touch Panel TFT-LCD
⑤Software: Self manufactured, UI and handling possible
⑥Exposure: Within 0.05 ~ 1.5 second range, exposure possible by 0.01 second
increment
⑦Battery: Use rechargeable 5Cell high capacity battery pack

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5.3 Product specifications
5.3.1 Device main body
①Item name: Portable X-RAY radiograph device
②Grade: Class Ⅱb (MDD 93/42/EEC as amended by 2007/47/EC)
③Tube voltage: 50 – 80 kV (variable)
④Tube current: 1 – 5 mA (variable)
⑤X-ray tube focal spot size: 0.8mm
⑥Voltage Consumption: 420W Max.
⑦Cooling method: Oil Cooling Method
⑧Total filtering: Over 2.5mm Al
(Inherent filtration: 1.0mm Al, fixed type added filter: 1.5mm aluminum)
⑨Target Angle: 16˚
⑩Time setting function: 0.05 - 1.5[sec.]
⑪Main body size: 322(L)x158(W)x178(H)
⑫Main body weight (including battery): 3.6kg
5.3.2 Battery Pack
Model name: LIP1902A
Cell material quality: Lithium Polymer
Charging condition
• Charging current: 1.0A

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• Charging voltage: 21VDC
• Temperature range: 0 - 40℃
Usage condition
• Maximum current: 63A
• Output voltage: DC 18.5V
• Temperature range: -20 - 60℃
5.3.3 Battery pack charging adapter
Model name: JBL702A211000002FJ
Input voltage: 100 - 240VAC, 50/60Hz, 0.5A
Output voltage: DC 21V
Output current: 1.0A

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6Product composition
6.1 Outline
In chapter 6, product parts are explained. Please read through this manual to
familiarize yourself with the device before using.
6.2 Product composition
iRayA6s contents listed below.
Main body: 1EA
Battery pack: 2EA
Battery charger: 1EA
Battery cradle: 1EA
Charger power cord: 1EA
Wired remote controller: 1EA
User Manual: 1EA
Storage case: 1EA
product warranty: 1EA
SSD cage: 1EA