USER Manual TABLE OF CONTENTS IRAYD3(DX3000) ................. 6 NTRODUCTION ..................6 1.1.1 Intended use ...................... 7 1.1.2 Contraindication ....................7 YMBOLS USED IN THIS ANUAL ............. 8 D3 ..............9 YMBOLS MARKED ON I D3 ........10 YMBOLS MARKED ON THE PACKAGING OF I ABELING LOCATION ................
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Name for each part on battery pack and charging devices ......28 6.3.4 HOW TO USE ................30 OWER ................. 30 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...
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10.1 P RODUCT PECIFICATION ..............59 10.2 P RODUCT ARRANTY ................60 11 IRAYD3(DX3000)TECHNICAL DOCUMENT ......61 11.1 H IGH VOLTAGE GENERATOR ..............61 11.1.1 X-RAY Tube: D-081B ..................61 11.2 E LECTROMAGNETIC COMPATIBILITY ............63 11.2.1 Electromagnetic Interference ................65 11.3 R...
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USER Manual MANUAL VERSION 4V10203_A Commented [U1]: Rev3 Revision date: 2019. 03. 01 4V10203_A [2019. 03. 01] - 전원 버튼 Silicon cap 적용 - 라벨 및 제품 크기 변경...
1 iRayD3(DX3000) 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.
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 Symbols used in this Manual SYMBOL NAME DETAIL Radiation “Radiation Warning” sign explains details of warning possible user radiation hazard. "Warning" sign explains details of possible user Warning damage, death or physical damage. "Caution" sign explains details of possible body Caution damage due to incorrect use of product.
USER Manual 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 This symbol advises the reader to consult the accompanying accompanying documents.
USER Manual Symbols marked on the packaging of iRayD3 SYMBOL NAME DESCRIPTION / FUNCTION This symbol means that transport package shall Keep away from rain be kept away from rain. This symbol means that contents of the Fragile transport package are fragile therefore it shall be handled with care.
USER Manual 2 Warning and instructions Symbols and details "Warning" sign explains details of possible user damage, death or physical damage. 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.
USER Manual Make sure fire extinguisher is onsite for fire emergency. When objects 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.
USER Manual 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.
USER Manual Symbols and details "Caution" sign explains details of possible body damage due to incorrect use of product. 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.
USER Manual 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 objects touch the device randomly, and keep it away from objects hands. ...
USER Manual 4 Items to check Symbol and Detail "Check" sign explains details of items that must be followed for product installation, operation, and maintenance Items to Check Please check battery pack and device condition, and confirm device operates accurately ...
○ Medical Device Name: Portable X-RAY System ○ Model Name: DX3000 ○ Product Name: iRayD3 ○ Display: : 2.35”LCD (Resolution: 128 x 64) - Exposure time setup - Remaining of battery - Exposure time setup by part of the animal teeth ○...
In chapter 6, product parts and each part are explained. Please be familiar with this manual before start of use of device. Product composition iRayD3 consists of items below. Main body: 1EA External Battery pack: 2EA Battery charging adapter: 1EA ...
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USER Manual Main body Battery pack Battery charging adapter Storage case Neck strap Power cord (sold separately) (sold separately) User Manual CD / Product Wired remote controller Back scattered shield warranty (sold separately) (sold separately) Figure 6.1 Product Composition...
USER Manual Product Explanation 6.3.1 Main body name Commented [U3]: 4V10203_A [2019. 03. 01] - Silicon cap 이미지 적용 Each part name of main body is as following. 2.35” LCD screen Time setting button Power button Product Label Hand strap Battery connector X-RAY exposure Power button silicon cap...
USER Manual 6.3.2 UI screen composition and functions ○ Name for each part on main control screen Status Status of Battery Dog image Exposure setting time Cat image Exposure Button Status (Dual, Left, Right, Remote) Figure 6.3 Name for each part on main control screen Dog image and Cat image: Indicates X-ray exposure target is animal.
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USER Manual ○ Name for each part on environment Setting screen Setting value MENU change method change method Automatic power disconnection setting Brightness setting Exposure interval time Battery level UI version Total exposure counts Figure 6.4 Name for each part on environment setting screen MENU change method: Indicates change of menu location when pressing ‘▼’...
USER Manual 6.3.3 Each part of the buttons and functions ○ Each part of top side buttons and functions Commented [U4]: 4V10203_A [2019. 03. 01] - Silicon cap 이미지 적용 Power button Time setting button Figure 6.6 Name for each part on top side buttons Power button: It is used to turn on/off the device and as combination button to ...
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USER Manual ○ Front side exposure button and function Right exposure button Left exposure button Figure 6.7 Front side exposure button Both buttons work when ‘DUAL BTN’ appears on Control Main screen. While one button is pressed for X-ray exposure, the other button doesn't work until the current X-ray exposure is finished.
USER Manual 6.3.4 Name for each part on battery pack and charging devices ○ Name for each part on battery pack Output terminal Battery label Battery state LED Charge terminal Figure 6.8 Name for each part on battery pack ○ N ame for each part on charging adaptor Charging adaptor label...
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USER Manual Charge source jack: Provides DC output power from adaptor Output indicating lamp: Indicates present output status. AC input connector: Connect with AC input of power cord. Charging adapter label: Indicates model name and input/output condition, certification, serial numbers.
USER Manual 7 How to use Power On/Off Insert enclosed battery to the right direction after opening battery cover at the bottom of main body. When pressing power button on the top of main body for 1 second, green light appears with buzzer sound around button and display is on with manufacturer’s logo as Figure 7.1.
1 minute at minimum to 10 minutes at maximum. CHECK The power button of iRayD3 will not work when pressing with other buttons. Please press just power button to turn on and turn off the device. X-RAY exposure positioning 7.2.1 object’s positioning...
USER Manual 7.2.2 Film or intraoral sensor positioning X-ray generated by iRayD3 can be detected by various detectors such as film, intraoral sensor (digital), PSP and viewed. Place film or sensor on the animal teeth and hold it with finger not to be moved.
USER Manual X-RAY exposure 7.3.1 X-RAY exposure sequence iRayD3’s X-ray exposure sequence is as below. Please set up the location of user and object at the best for shooting before exposure. ○ Set up the exposure time according to recommendation for target animal teeth or user’s experience and preference...
It could cause image distortion or decline of image quality. 7.3.2 X-RAY Exposure time set iRayD3’s x-ray exposure strength is fixed 60kV, 2mA and changeable by exposure time set. iRayD3’s x-ray exposure time set is adjustable from 0.05 to 1.35 seconds. ...
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USER Manual Radiation exposure is a concern in all animal of all ages, however, small animals are more sensitive to radiation exposure. Radiation risk is higher in small animals as they have more rapidly dividing cells than big animals. The small animals object, the more sensitive they are.
USER Manual Environment setup 7.4.1 Environment setup screen After turning on device, keep pressing the power button and ‘▲’ button at the same time then the screen is switched to environment setting screen as Figure 7.3. Figure 7.3 Environment setup screen ...
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USER Manual by 1minute. Brightness Setting up OLED display brightness level is available. The default level set is 250 and it is adjustable from 10 to 250 by 5 levels. Exp Interval It indicates the interval of current exposure time. ...
Wired remote controller operation is the same as exposure button function located on main body handle. If iRayD3 is mounted on stand that can be purchased separately, it is used for X-RAY exposure where user can be protected from X-RAY.
Insert the provided rubber ring into the hole of inside the back scattered shield. (Back scattered shield is already assembled with rubber ring) Equip iRayD3 with a back scattered shield at the front of cone. The shield must be ...
USER Manual Figure 7.5 Mounting back scattered shield with cone 7.6.2 Performance of back scattered shield Figure 7.6 indicates the scattering radiation area which is changed by the use of back scattered shield. Back scatter shield limits scattering radiation area to subject’s area and reduces ...
USER Manual Battery 7.7.1 Mounting battery inside Main body Check if iRayD3 device power is OFF. Please check the As shown in Figure 7.7 to displayed circle part. Figure 7.7 Battery cover separation Then insert the battery charging terminal into the product terminals to connect the power.
USER Manual Battery level and charging iRayD3’s battery is a high output power and is designed to charge separately from main body for safety purpose. Battery charging period can be notified through buzzer sound, OLED screen, low battery indicating lamp and at power turning on.
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USER Manual Figure 7.9 OLED screen when low battery Battery charger consists of charging adapter. Connect charger adapter DC plug to charging jack of battery pack. Use bundled AC power line to connect charger adapter, and connect to AC power code. AC power voltage range and frequency is 100 - 220V AC / 50 - 60Hz.
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USER Manual Figure 7.10 charger adapter and AC code ① Charge state ② Full charge state Figure 7.11 Battery pack status Caution Use only Dexcowin's adapter and cord originally packaged with the device to prevent damage to battery or accident. Otherwise, the warranty will be avoided or product liability by a manufacturer will be exempted.
USER Manual Application specification 7.9.1 Intended medical indication The ‘Potable Dental X-RAY System’ (Model Name: DX3000, Product Name: iRayD3) is indicated for use only by trained and qualified dentists or dental technician for animal subjects for taking diagnostic intraoral dental X-RAY using conventional film or digital sensors.
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USER Manual Table 7-4. Intended user profile CONSIDERATIONS REQUIREMENT DESCRIPTION Dentist Dental technician Minimum Education Radiologic Technologist or person who has a license equal to it. Maximum Every user has knowledge in risk from X-ray exposure. Minimum Every user understands the regulatory information of ICRP. Knowledge Every user can set the exposure conditions Maximum...
USER Manual 8 Maintenance and storage method Maintenance and storage Device or battery pack in safe place so people other than qualified personnel are being able to have access. X-RAY radiation field that contacts object directly should be maintained cleanly by wiping often with rubbing alcohol soaked wiping clothes.
USER Manual Cleaning procedure Clean the external surface using a damp cloth and non oil-based detergent and disinfect it using a non-aggressive medical detergent. The spacer cone may be cleaned with cotton wool soaked with surgical alcohol. CAUTION Turn off the device before carrying out cleaning operations. Do not spray products directly on the device.
USER Manual 8.3.2 Charging adaptor store Take caution not to have foreign substance at battery pack terminal, and wipe gently using cotton rod and soft clothes before storing. While not using the product, store after gently wiping. Take caution for battery pack (charger) not to contact with metallic substance (Coin, Key, Clip, and etc.).
8.5.1 On-going Check Periodically review Section ‘1.1.1 Intended use’ for use and product labeling in order to verify understanding of indications for use for the iRayD3. Section 2 Warning and instructions. Section 3 Caution and instructions. Section 4 Items to Check.
USER Manual 8.5.2 Annual User Check Users should review the following material yearly, and be sure to record their results in the Maintenance Log Sheets located in Section 8.5.3. ① Power button verification: If you press the power button for 1 second, a beep will sound to signal that the machine has powered on.
USER Manual 8.5.3 Annual Calibration The iRayD3 is factory calibrated and tested prior to release and there are no adjustment options. However, the optional checks listed below may be performed by a qualified technician as desired. Set up a calibrated Performance Meter (such as the Piranha554) according to manufacturer’s specifications to detect and report the following: X-ray Tube Voltage,...
USER Manual 8.5.4 Maintenance Log Sheet Table 8-2. Maintenance Log Sheet Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Maintenance Test Date Date Date Date Date Date /Initial /Initial /Initial /Initial /Initial /Initial 1. Power button 2.
USER Manual 9 Inspection items before repair request Check items before requesting inspection If abnormality is found in product, confirm following items before inspection request. SYMPTOM STEPS TO TAKE After turning on Confirm battery is mounted correctly and replace with power, both sound or charged battery.
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USER Manual SYMPTOM STEPS TO TAKE Check battery remaining, and replace with charged Low battery sign is battery pack. displayed on OLED Confirm if battery pack cover is closed and if it is screen open, check battery connection and close it by pushing cover all the way.
USER Manual Troubleshooting PROBLEM CAUSE SOLUTION No battery pack. Insert battery pack. Nothing lights up Low battery. Charge the battery. Generator is preparing an Wait for ready to X-ray exposure exposure. (about 5 seconds). Connect with wired remote No X-ray emission control or change “Exp Key “Remote”...
USER Manual 10 Product specification and product warranty 10.1 Product Specification CLASSIFICATION DETAILS Product name Portable X-RAY System Input power Use the external Battery B-type application Cone Waterproof Rating IPX0 (General Equipment) Mode of operation Discontinuous operation Tube voltage 60 [kV] (Fixed) Tube current 2 [mA] (Fixed) Focal spot size...
USER Manual 10.2 Product Warranty Dexcowin offers a manufacturer warranty for all products by One year from the purchase date or installation date. This product is manufactured under strict quality assurance standard and inspection process. If breakdown occurs during warranty period under normal usage, free repair service will be provided.
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Table 11-1. Electromagnetic emission The iRayD3 is intended for use in electromagnetic environment specified below. The customer or the user of the iRayD3 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance The iRayD3 uses RF energy only for its internal function.
USER Manual 11.3 Radiation Protection iRayD3 is IEC60601-1-3, IEC60601-2-28, IEC60601-2-65 from regulatory limits on radiation safety and protection compliant. X-RAY operator must protect him/herself with a lead apron or wall. Must provide a object protecting materials, such as a lead apron while operating.
USER Manual 11.5 Dose area product Dose area product [mGy x ㎠]= nominal radiation output [mGy] x 26.4 [㎠] Exposed surface (A) - Standard cone: 58 [mm] Diameter (Round) - A = π x r = 3.14 x (29 [mm]) = 26.4 [㎠] Table 11-6.
USER Manual 11.6 Leakage Radiation 11.6.1 Measurement in 1[m] from focal spot The following is leakage radiation at 1[m] from focal spot. Unit: [mR/h, (mGy/h)] ○ Right ○ Rear-right ○ Front-right Horizontal direction ○ ○ Rear-left ○ Front-left ○...
11.6.2 Measurement in 1[cm] from case surface The leakage radiation measured at 1 cm from surface of iRayD3 was operated at 13 different points and the locations are as Figure 11.5 and the results are as Table 11- ...
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USER Manual ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Figure 11.5 Measurement points in 1[cm] from case surface Table11-9. Leakage radiation at 1[cm] from case surface...
USER Manual 11.7.1 Set the significant zone of occupancy Personal protection equipment such as lead apron must be worn when shooting x- ray in the significant zone of occupancy as Figure 11.6. 200[cm] 60[cm] 60[cm] Figure 11.6 Significant zone of occupancy...
USER Manual 11.7.2 Test method and result of stray radiation The device and environment setup for measurement of stray radiation is Figure 11.7. After all setups, measure the stray radiation in the significant zone of occupancy. Considering use environment of device, set up distance between Focal spot and water equivalent phantom as 10cm and 15cm and measure.
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USER Manual Table 11-10. Stray radiation at 20[cm] from focal spot POINT A POINT B POINT C POINT D POINT E POINT F 0 cm 0.648 0.651 0.679 0.679 1.054 1.042 20 cm 1.029 0.729 1.025 0.848 0.759 0.814 40 cm 1.010 1.562 1.741...
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USER Manual The measurement results of stray radiation at 25cm from Focal spot are as Table 11-11. Table 11-11. Stray radiation at 25[cm] from focal spot POINT A POINT B POINT C POINT D POINT E POINT F 0 cm 0.968 0.714 0.684...
USER Manual 11.7.3 Stay radiation with back scattered shield application Attach back scattered shield as Figure 11.10 and measure stray radiation. Considering use environment of device, set up distance between Focal spot and water equivalent phantom as 10cm and 15cm and measure. The measuring points in the significant zone of occupancy are every 10cm point from ...
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USER Manual Table 11-12. Stray radiation at 20[cm] from focal spot with back scattered shield POINT A POINT B POINT C POINT D POINT E POINT F 0 cm 0.374 0.393 0.41 0.446 0.314 0.364 20 cm 0.577 0.581 0.637 0.351 0.418 0.324...
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USER Manual The measurement results of stray radiation at 25cm from Focal spot are as Table 11-13. Table 11-13. Stray radiation at 25[cm] from focal spot with back scattered shield POINT A POINT B POINT C POINT D POINT E POINT F 0 cm 0.323...
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