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Dexcowin cocoon DX-7017 User Manual

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  • Page 2 More Safe More Convenient More Durable COCOON (Model: DX-7017) User Manual...

  • Page 3: Table Of Contents

    Table of Contents Table of Contents ............................3 1 General Information ............................. 4 1.1 Notice ..............................5 1.2 Manufacturer & User Obligations ......................5 1.3 Symbols ............................... 7 1.4 Standards & Classifications ........................11 Safety Precautions ............................. 13 2.1 Radiation Safety ..........................14 2.2 dis Safety .............................

  • Page 4: General Information

    General Information 1.1 Notice 1.2 Manufacturer & User Obligations 1.3 Symbols 1.4 Standards & Classifications COCOON (Model: DX-7017) User Manual...

  • Page 5: Notice

    COCOON complies with the MDD 93/42/EEC as amended by 2007/47/EC. Refer to the Certificate of Conformance accompanying your device for verification. COCOON is a trademark registered by Dexcowin Co., Ltd in Korea and other countries. For further information not covered in this manual and any incidents concerning the device, please report it to the manufacturer at: DEXCOWIN CO., LTD.
  • Page 6 1.2 Manufacturer & User Obligations 1.2.1 Manufacturer’s Liability The manufacturer of this device assumes responsibility for the safe and regular operation of this device when: • The approved replacement parts are used. • All maintenance and repairs are performed by an authorized distributor/ manufacturer.

  • Page 7: Symbols

    1.3 Symbols The following symbols are used throughout this manual. The symbols descriptions, as well as other necessary information, are listed below. NOTE: Make sure to observe all safety and warning information based on their assigned symbols. Symbols used in this manual RADIATION Indicates a possible danger to users HAZARD...
  • Page 8 Symbols used on the device ELECTRICAL Indicates Insulated patient PROTECTION application (Type B). RADIATION Indicates a radiation hazard. HAZARD CAUTION Indicates a hazard. REFER TO Refer to the user manual and other DOCUMENTS accompanying documents. MANUFACTURER’S Indicates the name and address of INFORMATION the manufacturer.
  • Page 9 1.3.1 Label Locations 1. Generator(Inside) Label 2. Safety Label 3. Main Label COCOON (Model: DX-7017) User Manual...
  • Page 10 4. Adapter Label 5. Charging Cradle Label COCOON (Model: DX-7017) User Manual...

  • Page 11: Standards & Classifications

    1.4 Standards & Classifications COCOON is designed and manufactured to meet the following standards: ◆ ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (EN ISO 13485:2016) ◆ ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) ◆...
  • Page 12 ◆ 21 CFR Subchapter J ◆ Classifications The CE symbol granted this equipment The FDA symbol granted this equipment complies with the European Directive for complies with the applicable standards for Medical Devices 93/42/EEC as amended by Medical Devices under the 21CFR 2007/47/EC as a class IIb device.

  • Page 13: Safety Precautions

    Safety Precautions 2.1 Radiation Safety 2.2 Cleaning Safety 2.3 Storage & Transportation 2.4 General Warnings/Checks/Cautions COCOON (Model: DX-7017) User Manual...

  • Page 14: Radiation Safety

    2.1 Radiation Safety ➢ This X-ray unit could be dangerous to patients and operators unless safe exposure factors, operating instructions, and maintenance schedules are observed. ➢ A pregnant, or soon-to-be pregnant woman, and children must be advised before they are exposed to radiation. ➢...

  • Page 15: Dis Safety

    ➢ Do not use any liquid, wet cloth, or spray to clean this device. CAUTION ➢ The warranty will be void, and Dexcowin will be exempt from any product liability in the case the device is exposed to any liquids.

  • Page 16: Storage & Transportation

    2.3 Storage & Transportation ➢ To prevent unauthorized use, COCOON must be stored securely when not in use. WARNING ➢ The device must be stored in a safe place with access by qualified persons only. ➢ The X-ray section that is in direct contact with the patient should be cleaned with surface disinfectant frequently.

  • Page 17: General Warnings/Checks/Cautions

    ➢ If any serious accident occurs while operating the device, please contact the manufacturer (Dexcowin CO., LTD) by fax, e-mail, or contact the local authorities. ➢ The device must be stored in a protective case. Critical damage to the device may occur if placed in an unsafe area.
  • Page 18 Do not let the device get wet or be exposed to liquids ➢ ➢ Do not store the product in places with frequent temperature changes or direct sunlight for extended periods. In extreme temperatures, the high voltage generator's cooling and insulating oil can shrink, swell, freeze, or overheat, causing critical damage to the device and its ability to function.

  • Page 19: Getting Started

    Getting Started 3.1 Intended Use/Prohibited Use 3.2 Product Composition 3.3 Features & Specifications 3.4 Device Parts COCOON (Model: DX-7017) User Manual...

  • Page 20: Intended Use/Prohibited Use

    3.1 Intended use/ Prohibited Use COCOON is intended for use only by trained or qualified dentists and dental technicians for adult and pediatric patients. The device is designed for taking diagnostic intraoral dental X- rays using conventional film or digital sensors. It’s intended for use in a hospital/ clinical environment.

  • Page 21: Product Composition

    Product Composition Preliminary Checks ➢ Make sure that the serial number on the warranty matches the device and carrying case’s serial number. ➢ Inspect for damage; the lead lining must cover the entire interior surface. ➢ The trigger button should freely move in when pushed and out when released.

  • Page 22: Features & Specifications

    3.3 Features & Specifications COCOON is a portable X-ray device, used to treat and diagnose dental diseases, that is durable, safe, and convenient to use. Available features for users:  Exposure time automatically sets itself depending on the patient and tooth type ...
  • Page 23 Model Name DX-7017 X-RAY tube focal spot 0.4 mm (0.0157 inch) size Protection type B type Grade for electrical shock Waterproof rating IPX0 Mode of operation Discontinuous operation Cooling method Oil cooling method Total filtration More than 2.3mmAl (inherent filtration: 1.0 mmAl) Input power DC 14.8 V Target angle...

  • Page 24: Device Parts

    3.4 Equipment Part View Main Body FRONT BACK LEFT Item Description Power Button Power on/off button OLED Screen Display screen Neck Strap Ring Ring used to connect the neck strap to the device External Battery Where the external battery is connected terminal connector Back Scatter Shield A shield that blocks off back scattered radiation...
  • Page 25 OLED Display Screen Item Description Sensor Type Can select the sensor type Can select the type of patient receiving Patient Type diagnosis and treatment Can select the type of tooth being exposed to Tooth Type radiation Control Panel Selects parameters and changes its settings Indicates whether the X-ray is ready to emit radiation or not Exposure Light...
  • Page 26 Charger Item Description Output Indicator Lamp Displays whether the battery is fully charged or not Power Charging Jack Supplies DC output power from the adapter Lists the model’s name, input/output conditions, Charger Adapter Label certification, serial number, etc. AC Input Connector Connects the AC input of the power cord AC Power Cord Connects external AC power...
  • Page 27 Battery Charging Cradle Item Description Connects the output terminal of the battery pack to Charging Terminals the charging terminals of the charging cradle to charge the battery. Status of whether COCOON is finished charging or Charging Indicating not is indicated on the cradle using two different Lamp colors: red—charging, green—charging complete DC Input Connector...

  • Page 28: Operation

    Operation 4.1 Switching on the Device 4.2 Operating the Control Panel 4.3 Positioning 4.4 Battery Usage 4.5 Settings Menu 4.6 Exposure 4.7 User Guide COCOON (Model: DX-7017) User Manual...
  • Page 29 4.1 Powering Up ① Turn on the device by following the steps below: Control Panel Power Button Exposure Light ② After pressing the power button located at the top of the main body for one second, a green light should appear around the button. The device will then say, “power on.” The display screen will turn on and display the manufacturer’s logo.

  • Page 30: Operating The Control Panel

    4.2 Operating the Control Panel In the main menu screen, the detector type, patient type, tooth type, and exposure time can be adjusted. Each setting is adjustable by using the control panel. A. To select either an adult or child patient, push the ◀ ▶ keys on the control panel to go to the setting and then the ▲...

  • Page 31: Positioning

    4.3 Positioning In-order to achieve a high quality dental radiograph, take care to follow the radiograph processes below: Patient Positioning ◆ Place the patient in bilateral symmetry to the chair. ◆ Make sure the patient’s head remains still. ◆ It is recommended to position COCOON about 15~30˚ from the patient, but the degree and position can be adjusted according to the user’s convenience.
  • Page 32 Positioning COCOON ◆ The distance between the end of the cone and the patient must be within at least 18cm (7 inches) from the focal spot (X-ray focus point). ◆ The tooth being exposed to radiation (target tooth) should be located at the center of the cone to obtain a full image of the tooth.

  • Page 33: Battery Usage

    4.4 Battery Usage There are two types of batteries used for COCOON. Non-Removable Internal Battery This battery type is not detachable. It is embedded and not removable from the main body. Turn on the power to check that the device is operating properly. If any problem occurs during troubleshooting, see section 5.2 External Battery...
  • Page 34 ➢ A low battery level will be indicated by a buzzer sound, a warning pop-up on the screen, change of color on the indication lamp, or a battery warning sound when the power is turned on. ➢ The battery level is displayed on the upper right side of the main menu screen.
  • Page 35 Non-Removable Battery I. Connect the AC power cord to the charger. II. Connect the DC output connector to the cradle, and then insert the handle of the main body into the cradle. NOTE Both the battery charging cradle and DC adapter’s LED indicator turns red when the battery is charging.
  • Page 36 I. When the battery is fully charged, the DC adapter’s LED indicator will turn green. CAUTION Use only Dexcowin’s adapter and cord originally packaged with the device to prevent battery damage or failure. Use of the incorrect battery adapter or power supply will void the warranty and the manufacturer will be exempt from any liability.

  • Page 37: Settings Menu

    ➢ After the battery is fully charged, press and release the power button. The OLED display should illuminate, accompanied by a single audible signal. ➢ Check the battery level on the upper right side of the main menu screen. ➢ When the battery level is low, a warning noise and a low battery indicator lamp on the OLED window will be displayed.
  • Page 38 Sound effect This setting changes what sound COCOON makes. You can choose between a buzzer or speaker sound by touching the ▲▼ keys and select the desired option by touching the ▶ key. [*]Sign indicates which option is selected. Quick User Guide A brief description of the product is played for about three minutes after touching the ▶...

  • Page 39: Exposure

    Powering the Device Off To turn off COCOON, press the POWER button for one second. (COCOON will turn off automatically if not used for about 5 minutes.) 4.6 Exposure CAUTION The operator must tell the patient not to move when the device is in use. COCOON’S radiation exposure procedure is described below.
  • Page 40 only emitted when the buzzer sound emits. After radiation is emitted, the “READY” sign on the main menu screen will change to 'EXPOSURE.' The X-ray indicating light on the device will change from green to yellow. Before Exposure During Exposure During radiation exposure, the back scatter shield limits radiation exposed to the patient.
  • Page 41 X-ray Exposure Time Parameter COCOON's X-ray exposure strength is 70 [kV], 1.7[mA], 0.05-1.0 [s]. Its exposure time ranges anywhere between 0.05–1.0 [s]. Please refer to the table below to adjust the parameter for each teeth type. Classification Teeth types and exposure time Teeth 0.10 ~ 0.20 ~...

  • Page 42: User Guide

    4.7 User Guide 1. Press the power button for three seconds. The OLED display should illuminate, accompanied by a “power on” sound. 2. On the main menu screen, the user can select a setting using the ◀/▶ keys on the control panel.
  • Page 43 4. Check the safety lock position before operating the X-ray. Then press the trigger button. 5. Press the ◀ ▶ keys simultaneously for three seconds to activate/deactivate safety mode. 6. The position of the film, intraoral sensor, or PSP and COCOON’S cone should be parallel (as shown in section 4.3).

  • Page 44: Troubleshooting

    Troubleshooting 5.1 Inspection Checklist 5.2 Troubleshooting 5.3 Maintenance Schedule COCOON (Model: DX-7017) User Manual...

  • Page 45: Inspection Checklist

    5.1 Inspection Checklist If an abnormality is found in the device, confirm the following items before requesting to repair the device. Steps to Take If the Device Malfunctions Symptom Steps to Take After powering on the device, the OLED screen does not ➢...

  • Page 46: Troubleshooting

    5.2 Troubleshooting Problem Cause Solution Connect the device to a Nothing lights up The battery level is low charger. The generator is preparing to Wait about five seconds until emit radiation, so there is no the X-ray emits radiation No X-ray emission display on the screen.

  • Page 47: Maintenance Schedule

    5.3 Maintenance Schedule ◆ Periodically review Section 3.1 Intended use / Prohibition for Use and product labeling to verify instructions for COCOON. ◆ Users should regularly familiarize themselves with Section 2.4 General Warnings/checks/Cautions in the instructions. ◆ When a malfunction occurs, please refer to section 5.1 to inspect the item. Please contact the manufacturer/distributor immediately if the product seems to have any abnormalities.
  • Page 48 Compare results with the factory parameters indicated in the chart below. ◆ For results outside these parameters, discontinue use and contact DEXCOWIN. ◆ This device should be calibrated once a year. Acceptable ranges for the calibration...

  • Page 49: Equipment Specifications

    Equipment Specifications 6.1 Technical Specifications 6.2 X-ray Tube Characteristics & Specifications 51 6.3 EMC Data 6.4 Product Warranty COCOON (Model: DX-7017) User Manual...

  • Page 50: Technical Specifications

    6.1 Technical Specifications Item Description COCOON Dimension(mm) 308.8(L) x 304.95(H) x ø 152.8 Weight(kg) 2.17 Main Body Model name DXG-7017 Input voltage DC 14.8V High Voltage Max output power 105 W Generator Rating 70kV, 1.7mA Focal spot 0.4 mm (0.0157 inch) Target angle 12.5˚...

  • Page 51: X-Ray Tube Characteristics & Specifications

    6.2 X-ray Tube Characteristics & Specifications Specifications X-ray Tube model name D-041 Manufacturer TOSHIBA(JAPAN) Operating Tube Voltage 70kV X-ray Tube Focal Spot Nominal Anode Input Power (at 1.0s) See rating chart Constant Potential High-Voltage Generator 430W Anode Angle 12.5 degree Material Tungsten Inherent Filtration...
  • Page 52 3. Emission & Filament characteristics COCOON (Model: DX-7017) User Manual...

  • Page 53: Emc Data

    6.3 EMC Data ➢ Other cables and accessories may negatively affect EMC performance. ➢ Use of other accessories may result in non-compliance. ➢ COCOON should not be used in conjunction with other devices. If it is necessary to use in conjunction with other devices, make sure it is operating properly.
  • Page 54 Electromagnetic Emission COCOON is intended for use in the electromagnetic environment specified below. The customer or the user of the COCOON should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance COCOON uses RF energy only for its internal RF emissions –...
  • Page 55 Electromagnetic Susceptibility Field Contents Frequency range Field strength Modulation Frequency step Radiation field 3 [V/m] AM 80 [%] 80 ~ 2500 [MHz] 1 [%] / 3 step 10 [V/m] 1 [kHz] sine wave Axis of Test frequency Field level(EMF) Duration orientation Magnetic field...

  • Page 56: Product Warranty

    Warranty Period of purchase E-mail Purchase Date ◆ Dexcowin offers a manufacturer warranty to all products for one year from the date of purchase or installation date. ◆ This product is manufactured under strict quality assurance standards and inspection processes.
  • Page 57 #901~905, 25, Gasan digital 1-ro, Geumcheon-gu, Seoul, 08594, Korea Tel: +82 2 3402 5500 Fax: +82 2 3402 5539 Website: www.dexcowin.com Email: info@dexcowin.com COCOON (Model: DX-7017) User Manual...

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