Dexcowin iRay D3 User manual

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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 IRAY D3............................................................... 9
1.4 SYMBOLS MARKED ON THE PACKAGING OF IRAY D3 .................................. 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
2.3WARNINGS 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

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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 External Battery Pack& Embedded 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 UIscreen composition and functions............................................................................... 24
6.3.3 Each part of the buttons and functions......................................................................... 26
6.3.4 Name for each part on external 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 iRay D3 positioning................................................................................................................. 35

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7.3 X-RAY EXPOSURE ............................................................................... 35
7.3.1 X-RAY exposure sequence ................................................................................................... 35
7.3.2 X-RAYExposure 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 Embedded battery type ........................................................................................................ 45
45
7.7.2 Connect the External Battery on the Main body ....................................................... 46
7.7.3 Battery level................................................................................................................................ 47
7.7.4 Battery charging ....................................................................................................................... 48
7.8 NECK STRAP ....................................................................................... 52
7.8.1 How to use Neck strap.......................................................................................................... 52
7.9 APPLICATION SPECIFICATION.................................................................. 53
7.9.1 Intended medical indication................................................................................................ 53
7.9.2Intended patient population............................................................................................... 54
7.9.3 Intended user profile.............................................................................................................. 54
8MAINTENANCE AND STORAGE METHOD ........................... 55
8.1 MAINTENANCE AND STORAGE ............................................................... 55
8.2 CLEANING PROCEDURE ......................................................................... 56
8.2.1 Check for Product storage................................................................................................... 56
8.3 STORAGE METHOD............................................................................... 57
8.3.1 Check for Product storage................................................................................................... 57

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8.3.2 Charging adaptorstorage...................................................................................................... 57
8.4 PRODUCT TRANSPORTATION,STORAGE CONDITIONS AND CONDITIONS OF USE 57
8.4.1 Transportation and storage conditions.......................................................................... 57
8.4.2 Optimal conditions of use.................................................................................................... 58
8.5 MAINTENANCE SCHEDULE..................................................................... 58
8.5.1 On-going Check ....................................................................................................................... 58
8.5.2 Annual User Check .................................................................................................................. 59
8.5.3 Annual Calibration ................................................................................................................... 60
8.5.4 Maintenance Log Sheet ........................................................................................................ 61
9INSPECTION ITEMS BEFORE REPAIR REQUEST................... 62
9.1 CHECK ITEMS BEFORE REQUESTING INSPECTION ......................................... 62
9.2 TROUBLESHOOTING ............................................................................. 64
10 PRODUCTSPECIFICATION AND PRODUCT WARRANTY.... 65
10.1 PRODUCT SPECIFICATION ...................................................................... 65
10.2 PRODUCT WARRANTY .......................................................................... 66
11 IRAY D3(DX3000)TECHNICAL DOCUMENT.......................... 67
11.1 HIGH VOLTAGE GENERATOR................................................................... 67
11.1.1 X-RAY Tube: D-081B............................................................................................................... 67
11.2 ELECTROMAGNETIC COMPATIBILITY ......................................................... 69
11.2.1 Electromagnetic Interference .............................................................................................. 71
11.3 RADIATION PROTECTION ...................................................................... 72
11.4 NOMINAL RADIATION OUTPUT ............................................................... 72
11.5 DOSE AREA PRODUCT........................................................................... 74
11.6 LEAKAGE RADIATION............................................................................ 76
11.6.1 Measurement in 1[m] from focal spot............................................................................ 76
11.6.2 Measurement in 1[cm] from case surface..................................................................... 77

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11.7 STRAY RADIATION ............................................................................... 80
11.7.1 Set the significant zone of occupancy............................................................................ 80
11.7.2 Test method and result of stray radiation .................................................................... 81
11.7.3 Stay radiation with back scattered shield application ............................................. 84
MANUAL VERSION 3.20171-A
Revision date: 2019.03.01

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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 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.

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1.1.1 Intended use
iRayD3 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.
1.1.2 Contraindication
The iRayD3 are contraindicated for use on patients who known to be or possibly
pregnant.

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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" 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 productinstallation,
oepration, and maintenance.

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1.3 Symbols marked on iRayD3
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.
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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1.4 Symbols marked on the packaging of iRayD3
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
thetransportpackage arefragile thereforeit shall
behandled withcare.
This way up This symbol means that indicates correct upright
position of the transport package.

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1.5 Labeling location
1.5.1 Outside
1.5.2 Inside: X-ray tube assembly
Figure1.1 Labeling on X-ray tube assembly

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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 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
powerimmediately, and contact the closest customer support center.
Make sure fire extinguisher is onsite for fire emergency.

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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 exposedin 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.
Do not connect an external battery to the device while the device is turned on.
If you want to use the external battery, make sure that the device is turned off and
connect the external battery for use.
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.

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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 the device connected to charging adaptor 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.

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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
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.

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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

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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
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.

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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
○
1E
AMedical Device Name: Portable X-RAY System
A○
2E
AModel Name: DX3000
A○
3E
AProduct Name: iRay D3
A○
4E
ADisplay: 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
A○
5E
AFunction 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
A○
6E
AEmbedded battery application and external battery supply as default.

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5.3 Product specifications
5.3.1 Device main body
A○
1E
ADevice Name: Portable X-RAY System
A○
2E
ATube voltage: 65 [kV] (Fixed)
A○
3E
ATube current: 1.7 [mA] (Fixed)
A○
4E
AX-RAY tube focal spot size: 0.8 [mm]
A○
5E
APower consumption: 220 [VA]
A○
6E
ACooling method: OIL Cooling Method
A○
7E
ATotal Filtration: Over 2.3 [mmAl] (inherent filtration: 0.8 [mmAl])
A○
8E
ATarget Angle: 20˚
A○
9E
ATime setting function: 0.05–1.35[sec]
A○
10E
ADistance to target: Distance between target and Focal Spot > 20 [cm] (8 [inch])
A○
11E
AMain body size: 139(W)x164.3(D)x65(H) [mm] (Exclude cone)
A○
12E
AMain body weight: 2.4 [kg] (Inclusion battery)
5.3.2 External Battery Pack& Embedded Battery Pack
Model name: PF435060HP-4S
Cell material: Lithium Polymer
Charging condition
-Charging current: 1.0 [A]