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Maxray DX3000 User Manual

Convenience portable x-ray
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  • Page 2: Table Of Contents

    USER Manual TABLE OF CONTENTS 1 DX-3000 ..............5 ..................5 NTRODUCTION .............. 6 YMBOLS USED IN THIS ANUAL ..............7 ABEL AND MARKING YMBOLS ..................8 EVICE LABELING 2 WARNINGS AND INSTRUCTIONS ....... 9 ................9 YMBOLS AND DETAILS ................
  • Page 3 USER Manual 5 PRODUCT FEATURES ........... 15 ..................... 15 UTLINE ................15 RODUCT EATURES 5.2.1 Features ......................15 ..............16 RODUCT SPECIFICATIONS 5.3.1 Device main body ................... 16 5.3.2 Battery Pack ..................... 16 5.3.3 Battery pack charging adapter ................ 17 5.3.4 Battery charging cradle ...................
  • Page 4 USER Manual ................35 NVIRONMENT SETUP 7.4.1 Environment setup screen ................35 7.4.2 Environment setup list ..................36 .................. 38 UNCTION SETUP 7.5.1 Function setup screen ..................38 7.5.2 Function setup list ................... 38 ..............41 IRED REMOTE CONTROLLER 7.6.1 Wired remote controller usage ...............
  • Page 5 USER Manual 10 PRODUCT SPECIFICATION AND QUALITY ASSURANCE ..............53 10.1 P ............... 53 RODUCT PECIFICATION 10.2 Q ................54 UALITY ASSURANCE 11 DX-3000 TECHNICAL DOCUMENT ..... 55 11.1 H ..............55 IGH VOLTAGE GENERATOR 11.1.1 X-ray Tube : Toshiba D-081B ................. 55 11.2 E ............

  • Page 6: Dx-3000

    USER Manual 1 DX-3000 Introduction Thank you for purchasing the portable X-ray system from Iridium Dental. DX-3000 has been developed to not only take radiographs in an analog fashion using conventional film, but also to be used in Dental Digital Radiography (DDR) using a digital sensor.

  • Page 7: Symbols Used In This Manual

    USER Manual Symbols used in this Manual SYMBOL NAME DETAIL Radiation The “Radiation Warning” sign explains details about possible radiation hazards and the potential warning for injury or death with improper use. The "Warning" sign explains details about improper Warning use which may cause physical damage to the product.

  • Page 8: Label And Marking Symbols

    USER Manual Lables and markings: Symbols SYMBOL NAME DESCRIPTION / FUNCTION Electrical protection Insulated patient application (Type B). Radiation warning This symbol indicates radiation hazards. Warning This symbol indicates general hazards. Consult This symbol advises the reader to consult the accompanying accompanying documents.

  • Page 9: Device Labeling

    USER Manual Device labeling...

  • Page 10: Warnings And Instructions

    USER Manual 2 Warnings and instructions Symbols and details The "Warning" sign explains details about improper use which may cause physical damage to the product. Warnings for use 2.2.1 Warnings for product use  Ensure that the radiation exposure limit required for image diagnosis is not exceeded. ...

  • Page 11: Warnings For Battery Use

    USER Manual 2.2.2 Warnings for battery use  Use only the provided designated battery!  Do not expose the battery to strong electrical currents, and keep it away from sharp objects.  If the battery is kept under high temperature, it may explode. ...
  • Page 12 USER Manual cooling and insulating oil could shrink, swell, freeze, or overheat, causing critical damage to device functions.  Do not store product with explosive gas or chemicals.  Do not leave the battery pack connected to the charger during storage.

  • Page 13: Caution And Instructions

    USER Manual 3 Caution and instructions Symbols and details The "Caution" sign explains details about improper use which may cause bodily harm to the user. Caution and instructions 3.2.1 Caution for product storage  Moisture, salinity, dust, etc. can affect the performance of device. Do not store the device in places where such conditions may be present.

  • Page 14: Caution Of Other Matters

    USER Manual Caution for other matters  In the event that the device breaks down, mark it as such and send it to a designated professional at the A/S center.  Do not let patients touch the device. Do not leave it unsupervised. ...

  • Page 15: Items To Check

    USER Manual 4 Items to check Symbol and Detail The "Check" sign explains instructions that users must follow for product installation, operation, and maintenance. Items to Check  Check the condition of the device and battery pack before using. Confirm the that the device is operating properly.

  • Page 16: Product Features

    USER Manual 5 Product Features Outline In Chapter 5, the features and specifications of this device are explained for safe usage. Product Features 5.2.1 Features > Medical Device Name: Portable X-ray System > Model Name: DX-3000 > Display: 2.5” LCD (Resolution: 128 x 64) - Adult and child mode - Film and digital mode - Remaining battery life...

  • Page 17: Product Specifications

    USER Manual - Continuation of LCD backlight time setup > Removable and rechargeable battery supply. Product specifications 5.3.1 Device main body > Device Name: Portable X-ray System > Tube voltage: 65 kV (Fixed) > Tube current: 2.5 mA (Fixed) > X-ray tube focal spot size: 0.8 mm >...

  • Page 18: Battery Pack Charging Adapter

    USER Manual  Cell material: Lithium Polymer  Charging conditions - Charging current: 1.0 [A] - Charging voltage: DC 16.8 [V] - Temperature range: 0 – 40 [℃]  Usage conditions - Maximum output current: 26 [A] - Output voltage: DC 15 [V] - Temperature range: -20 –...

  • Page 19: Product Composition

    USER Manual 6 Product composition Outline In Chapter 6, specific product parts are explained. Be familiar with the entire manual before using the device. Product composition The DX-3000 consists of the items below.  Main body: 1 ea  Battery pack: 2 ea ...
  • Page 20 USER Manual Main body Battery charging adapter Battery Battery charging cradle Power cord Storage case User Manual CD / Wired remote controller Backscatter shield Product warranty (sold separately) Figure 6.1 Product Composition...

  • Page 21: Product Explanation

    USER Manual Product Explanation 6.3.1 Main body parts The parts of the main body are labeled as follows: 2.35” Graphic LCD Time setting button Power button Label Hand strap X-ray exposure indicating light Remote control Low battery indicating light connector X-ray exposure button X-ray field...

  • Page 22: Ui Screen Composition And Functions

    USER Manual 6.3.2 User interface (UI) screen composition and functions ○ Main control screen Status Adult tooth Status of Battery Adult image Exposure setting time Child image Remote mode icon Child tooth Film / digital mode icon Time setting unit Figure 6.3 Main control screen Adult image and adult tooth: Indicates recommended adult tooth by time setting.
  • Page 23 USER Manual ○ Environment Settings screen To change the value To change the MENU of individual settings. Film/digital mode setting Automatic shutoff setting Backlight time setting UI version Battery level Total exposure counts Figure 6.4 Environment settings screen MENU change: Indicates the menu options, which can be navigated by ...
  • Page 24 USER Manual Total exposure counts: Indicates the number of x-ray exposures that have  occurred. UI version: Indicates the current UI version number.  ○ Function Setting Screen Exposure button enable / disable setting Max exposure time setting Exposure start time setting Exposure time unit setting Factory Defaults Figure 6.5 Function setting screen...

  • Page 25: Buttons And Functions

    USER Manual 6.3.3 Buttons and functions ○ Top side buttons and functions Time setting button Power button Figure 6.6 Top side buttons and functions Power button: Used to turn on/off the device and as combination button to  enter the environment setup or function setup menus. Time setting button: ...
  • Page 26 USER Manual ○ Front side exposure button and function Figure 6.7 Front side exposure button  If ‘Dual’ is selected on the ‘exposure button enable/disable’ function setup display, pressing and holding the exposure button will cause the X-ray exposure.  The X-ray exposure is accompanied by a tone while the button is engaged.

  • Page 27: Battery Pack And Charging Devices

    USER Manual 6.3.4 Battery pack and charging device parts ○ Battery pack parts Battery pack label Output terminal (+) Output terminal (-) Figure 6.8 Battery pack parts Battery pack label: Indicates the battery model name, manufacturer's address  and serial numbers, as well as providing certain precautions. Output terminal (+,-): Provides power when the battery pack is inserted into the ...
  • Page 28 USER Manual Charge indication light: Indicates the status of battery charge using three  different colors (red - charging; green - fully charged; yellow - charging error) Charging terminals: Connect the output terminals of the battery pack to the  charging terminals of the charging cradle to charge the battery.
  • Page 29 USER Manual Output indicating light: Indicates present output status.  AC input connector: Connect with the AC input of the power cord.  Charging adapter label: Indicates model name and input/output condition,  certification, serial numbers. AC power cord: Connect to an external AC power source. ...

  • Page 30: How To Use

    USER Manual 7 How to use Power On/Off After opening the battery cover at the bottom of the main body, insert the  battery pack, ensuring that it is inserted in the proper orientation. Hold down the power button on top of the main body for 1 second. A green light ...

  • Page 31: X-Ray Exposure Positioning

    USER Manual Figure 7.2 main control display CHECK The DX-3000 has an automatic shutoff function in order to reduce battery consumption. The automatic shutoff time is set for three minutes after the device has not been used. The automatic shutoff time can be adjusted by the user in the settings menu from 1 minute to 10 minutes, in 1 minute intervals.

  • Page 32: Film Or Intraoral Sensor Positioning

    USER Manual 7.2.2 Film or intraoral receptor positioning X-rays generated by the DX-3000 can be detected by various receptors such as  film, intra-oral sensors (digital), PSP and viewed screens. Place the film or sensor on the teeth and make sure it does not move. ...

  • Page 33: Dx-3000 Positioning

    USER Manual 7.2.3 DX-3000 positioning The distance between the end of the cone and the patient must be within  at least 20cm (8 inch) from the X-ray focal spot.  The target teeth must be positioned at the center of the cone in order to cover the whole tooth structure.
  • Page 34 USER Manual After pressing the exposure button, a tone warns that X-ray exposure has  begun, and X-ray exposure continues with a corresponding tone. X-rays are only generated during the period of the consecutive tone and while the button is held. While X-rays are generated, the ‘READY’...

  • Page 35: Setting X-Ray Exposure Time

    USER Manual 7.3.2 Setting X-ray Exposure time The DX-3000’s X-ray exposure factors are fixed at 60 kV, 2.0 mA and is  changeable only by exposure time. The DX-3000’s X-ray exposure time is adjustable from 0.02 to 2.5 seconds.  ...

  • Page 36: Environment Setup

    USER Manual CAUTION Exposure time settings by teeth type can vary according to the sensor type and film, distance to patient, and the image preference. Please refer to the settings as recommendations only. Environment setup 7.4.1 Environment setup screen After turning on the device, press the power button and the ▲ button at the ...

  • Page 37: Environment Setup List

    USER Manual 7.4.2 Environment setup list MODE  Once you choose Film or Digital mode, the relevant teeth images for each  exposure sector are applied. Press the ▲ button to select ‘MODE’ and press the ▼ button to choose ‘Film’ ...
  • Page 38 USER Manual Backlight  The LCD display backlight time is adjustable.  The default time is set to 1 second and it is adjustable from 1 second to  10 seconds, by 1 second intervals.  Battery life remaining is indicated on the display. ...

  • Page 39: Function Setup

    USER Manual Function setup 7.5.1 Function setup screen  After turning on the device, press the power button and the ▼ button at the same time for a second to reach the function setup display (see Figure 7.6). Figure 7.6 Function setup screen Press the ▼...
  • Page 40 USER Manual  Press the ▼ button to select ‘Expkey Set’ and the ▲ button to choose ‘Dual’ (exposure button enabled) or ‘Remote’ (exposure button disabled/ remote control use only). When selecting 'Remote', 'R' will appear on the main control display and will ...
  • Page 41 USER Manual ExpUnit Time   Changes the time modification unit for exposure time. It is adjustable from 0.01 seconds to 0.1 seconds, by 0.01 second intervals. Press the ▼ button to select ‘ExpUnit Time’ and press the ▲ button to adjust ...

  • Page 42: Wired Remote Controller

    USER Manual Wired remote controller 7.6.1 Wired remote control usage Wired remote control jack Wired remote control connector Figure 7.9 Wired remote control connection Connect the wired remote control connector to the wired remote control  jack on the front face of the DX-3000. The remote control jack has to be connected completely inside the connector for proper operation.

  • Page 43: Battery

    USER Manual If the button is pressed after the exposure range has been adjusted, X-ray  exposure will occur. The wired remote control only performs X-ray exposure. Other settings and  operations must be manipulated through the LCD screen on the device. Battery 7.7.1 Mounting the battery inside the main body...

  • Page 44: Battery Level And Charging

    USER Manual arrow from the side of the main body, with the battery label face-down (see Figure 7.11). The battery should fit into the slot's grooves smoothly. Close the battery cover. The cover will connect with the main body and make a ...
  • Page 45 USER Manual When battery replacement is necessary, the battery level on the LCD display  indicates ‘LOW’ and a ‘LOW’ battery image appears on the upper right part of the main control display. The batter y replacement - indicating li g h t on t h e upper part of main body will be yellow, as well.
  • Page 46 USER Manual Figure 7.13 LCD screen after battery dies  The battery charger consists of a charging adapter and a charging cradle (Figure 7.14).  Connect the charger adapter DC plug to the charging jack on the back side of the charging cradle.
  • Page 47 USER Manual Figure 7.14 Battery cradle and charger adapter ① Connect the charger DC plug to the back side ② Fit the battery intro the cradle of the jack on the battery in the direction shown here cradle. ③ Charging begins after the battery is in place Figure 7.15 Connecting the battery into the cradle...

  • Page 48: Maintenance And Storage

    USER Manual 8 Maintenance and storage Maintenance  Keep the device and battery pack in a safe place where only qualified personnel have access.  The collimating cone that comes into direct contact with the patient should be cleaned by gently wiping with a clean cloth and rubbing alcohol. ...

  • Page 49: Storage

    USER Manual Storage 8.2.1 Checks for Product storage  Avoid places with high humidity or direct sunlight. Avoid place with lots of dirt and dust, as well as sloped surfaces.   Do not store in extremely high or low temperatures. ...

  • Page 50: Optimal Conditions Of Use

    USER Manual 8.3.2 Optimal conditions of use 1. Temperature: 10 ~ 30 ℃ 2. Relative humidity: 30 ~ 60 % 3. Atmospheric pressure: 900 ~ 1060 Hpa Items to check 8.4.1 Frequent inspection items When turning powering on the product, confirm that the power-on sound is heard ...

  • Page 51: Inspection Items Before Repair

    USER Manual 9 Inspection items before repair request Check items before requesting inspection If an abnormality is found with the product, confirm the following items before requesting inspection. Symptom Steps to take After powering on,  Confirm that the battery is inserted correctly or tone is not heard and replace it with a charged battery.
  • Page 52 USER Manual Symptom Steps to take  Check remaining battery life, and replace it with a Low battery sign is charged battery pack, if needed. displayed on the  Check the battery connection and be certain that LCD screen the battery pack cover is closed. ...

  • Page 53: Troubleshooting

    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 X-ray exposure to be exposure. Displays “WAIT”. ready (about 10 seconds). Connect the wired remote control or change “Expkey Set”...

  • Page 54: Product Specification And Quality Assurance

    USER Manual Product Specification and Quality Assurance 10.1 Product Specification Classification Details Portable X-ray System Product name Use the internal power supply (Battery) Input power Cone B-type application IPX0 (General Equipment) Waterproof rating Continuous operation Mode of operation 60 kV (Fixed) Tube voltage 2.0 mA (Fixed) Tube current...

  • Page 55: Quality Assurance

    USER Manual 10.2 Quality assurance Product Quality Assurance Certificate Medical DX-3000 Portable X-ray System Type name device name Manufacturing Manufacture number date Customer Contact name information Customer Address Warranty Place of 1 year after purchase purchase Period E-mail Purchase date This product is manufactured under a strict quality assurance standard and inspection process.

  • Page 56: Dx-3000 Technical Document

    USER Manual 11 DX-3000 Technical Document 11.1 High voltage generator 11.1.1 X-ray Tube : D-081B 1. Manufacturer: TOSHIBA(Japan) 2. Electrical Characteristics  Operating Tube Voltage ………………………………………………………………….60 kV  Focal Spot ……………………………………………………………………………..………0.8 mm  Input Power (at 1.0s) ……………………………………………………………………..600 W 3. Mechanical Characteristics Dimensions ...
  • Page 57 USER Manual  Target angle …………………………………………………………………………20 Degrees  Target material …………………...……………………………………………Tungsten  Inherent Filtration ………………………At least 0.8 mmAl equivalent at 50kV  Anode Thermal Characteristics Figure 11.2 Anode Heating/Cooling curve 4. Absolute Maximum and Minimum Ratings  Maximum Tube Voltage ……………………………………………………….………..65 kV ...

  • Page 58: Electromagnetic Compatibility

    USER Manual Figure 11.3 Maximum tube current curve by exposure time 11.2 Electromagnetic compatibility The DX-3000 has been tested and found to comply with the limits for medical devices in IEC/EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference with other devices in the vicinity.

  • Page 59: Radiation Protection

    USER Manual 11.3 Radiation Protection The DX-3000 is compliant with the regulatory limits on radiation safety and protection as defined in IEC60601-1-3, IEC60601-2-28, and IEC60601-2-65.  The device operator must protect him/herself with a lead apron or separating wall. The patient must be provided protective materials such as a lead apron and thyroid ...

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