Dexcowin COCOON DX-7020 User Manual Download Page 11 | Manualshive

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(Model: DX-7020) User Manual

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1.4 Standards & Classifications

DX-7020 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)

◆

EN 60601-1:2006 Medical electrical equipment

–

General requirements for basic safety and

essential performance (IEC 60601-1:2005/AMD1: 2012)

◆

IEC 60601-1:2012, Medical electrical equipment

–

General requirements for basic safety and

essential performance

◆

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests

[Rev1]

◆

EN 60601-1-3:2008/A11:2016, Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential performance - Collateral Standard: Radiation
protection in diagnostic X- ray equipment

◆

IEC 60601-1-6:2010/AMD1:2013 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral Standard: Usability

◆

IEC 60601-2-28:2010

◆

IEC 60601-2-65:2012+AMD1:2017, Medical electrical equipment - Part 2-65: Particular
requirements for the basic safety and essential performance of dental intra-oral X-ray
equipment.

◆

IEC 62366-1:2015 Medical devices-part1: Application of usability engineering to medical
devices.

◆

IEC62304: 2015 Medical device software

–

software life cycle processes.

◆

ISO 14155-1:2010 Clinical investigation of medical devices for human subjects

◆

EN ISO 15223-1:2016, Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General requirements

◆

EN1041:2008 Information supplied by the manufacturer of medical devices

◆

ISO 10993-1:2009 Biological evaluation of medical devices- Part1 : Evaluation and within a
risk management process

◆

ISO 17050-1:2010 Conformity assessment-

supplier’s declaration of conformity –

part 1:

General requirements.

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Summary of Contents for COCOON DX-7020

Page 1: ...USER MANUAL Model DX 7020 Manual Version 1820 8 ...

Page 2: ... Model DX 7020 User Manual 2 More Safe More Convenient More Durable ...

Page 3: ...ed use Prohibited Use 20 3 2 Product Composition 21 3 3 Features Specifications 22 3 4 Device Parts 24 4 Operation 28 4 1 Switching on the Device 29 4 2 Operating the Control Panel 30 4 3 Positioning 31 4 4 Battery Usage 33 4 5 Settings Menu 38 4 6 Exposure 40 4 7 User Guide 43 4 8 Handle Replacement 45 5 Troubleshooting 47 5 1 Inspection Checklist 48 5 2 Troubleshooting 49 5 3 Maintenance Schedul...

Page 4: ... Model DX 7020 User Manual 4 1 General Information 1 1 Notice 5 1 2 Manufacturer User Obligations 6 1 3 Symbols 7 1 4 Standards Classifications 11 ...

Page 5: ...drawings and descriptions for the DX 7020 Do not operate this device until you have read and reviewed this accompanying user manual completely DX 7020 complies with the MDD 93 42 EEC as amended by 2007 47 EC Refer to the Certificate of Conformance accompanying your device for verification DX 7020 is a trademark registered by Dexcowin Co Ltd in Korea and other countries For further information not ...

Page 6: ...y unit could be dangerous to patients and operators unless safe exposure factors operating instructions and maintenance schedules are observed 1 2 2 User Obligations The user must perform periodic tests at regular intervals to ensure safety These tests must be performed and follow country and local X ray safety regulations The user must perform regular inspection and maintenance of the mechanical ...

Page 7: ...on WARNING Indicates details of possible user damage or physical damage CAUTION Indicates that injury may occur if the product is used incorrectly CHECK Indicates the necessary items that users should follow during product installation operation and maintenance Symbols Used on DX 7020 s Packaging KEEP DRY Indicates that the transported package should be kept away from rain or damp areas FRAGILE In...

Page 8: ...ce s serial number REPRESENTATIVE ADDRESS This symbol represents the manufacturer s EU representative s information WASTE ELECTRICAL ELECTRONIC EQUIPEMENT WEEE This symbol Indicates the need for a separate collection of electrical and electronic equipment in compliance with the Waste Electrical and Electronic Equipment WEEE Directive This symbol indicates that electrical and electronic equipment w...

Page 9: ... Model DX 7020 User Manual 9 1 3 1 Label Locations 1 Generator Label located inside 2 Charging Cradle Label 3 4 2 5 ...

Page 10: ... Model DX 7020 User Manual 10 3 Adapter Label 4 Main Label ...

Page 11: ...tial performance Collateral Standard Radiation protection in diagnostic X ray equipment IEC 60601 1 6 2010 AMD1 2013 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral Standard Usability IEC 60601 2 28 2010 IEC 60601 2 65 2012 AMD1 2017 Medical electrical equipment Part 2 65 Particular requirements for the basic safety and essential per...

Page 12: ...ion against electric shock Class II equipment Type B REFERENCES Patent No Korea 1023431200000 1007993140000 1009411250000 1014040040000 United States of America 11185300 The CE symbol grants this equipment complies with the European Directive for Medical Devices 93 42 EEC as amended by 2007 47 EC as a class IIb device ...

Page 13: ... Model DX 7020 User Manual 13 2 Safety Precautions 2 1 Radiation Safety 14 2 2 Cleaning Safety 15 2 3 Storage Transportation 16 2 4 General Warnings Checks Cautions 17 ...

Page 14: ...e to natural background radiation for Additional lifetime risk of cancer from examination DENTAL Dental X ray 0 005mSv 1day Negligible Reference site http www radiologyinfo org en safety index cfm pg sfty_xray Diagnostic Reference Levels in Pediatrics for standard five year old patients expressed in entrance surface dose per image for single views Diagnostic Reference Level in Pediatrics CHECK Rad...

Page 15: ...re cleaning Do not clean the battery charger while it is plugged into an outlet This device is not waterproof IPX0 Do not use any liquid wet cloth or spray to clean this device The warranty will be void and Dexcowin will be exempt from any product liability in the case the device is exposed to any liquids WARNING ...

Page 16: ...gular testing and repairs should be performed by designated repair service centers only Avoid the following conditions when storing and using the device Locations with lots of moisture Locations with direct sunlight Locations with lots of dust Locations with high humidity Locations with no ventilation Locations with excessive salt Locations with explosive chemical substances or gases CHECK Avoid l...

Page 17: ...not let liquids near the device power supply or plug 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 CAUTION The device must be stored in a protective case Critical damage to the device may occur if placed in an unsafe area Do not place the device on a high shelf or any narrow unsafe place If t...

Page 18: ... freeze or overheat causing critical damage to the device and its ability to function If the device fails to operate properly label each part properly and inform the designated personnel at the repair service center of the issue s at hand Patients should not touch the device If they do so it will be at their own risk After the device has been dropped do not attempt to turn it on Detach the power s...

Page 19: ... Model DX 7020 User Manual 19 3 Getting Started 3 1 Intended Use Prohibited Use 20 3 2 Product Composition 21 3 3 Features Specifications 22 3 4 Device Parts 24 ...

Page 20: ...r Requirements Education A licensed dentist or dental assistant radiologist and graduates with a relevant bachelor s degree national qualifications Knowledge The operator must understand How to treat and diagnose dental diseases How the device functions How to connect install and operate the device Language The operator must understand The English manual Experience The operator must understand How...

Page 21: ... 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 The device should be smooth and free of scratches damages or nicks ...

Page 22: ...intervals Trigger makes the DX 7020 convenient and easy to use Automatic power off feature Designed for user wrist protection Specifications CHARGER Model name BPL910S16F01 Input AC 100 240 V 50 60 Hz 0 5 A Output voltage DC 16 8V Output current 1 0A BATTERY CHARGING CRADLE Model name Cradle Charging voltage DC 16 8V Charging current 1 0A Discharge voltage at the time of battery connection Varies ...

Page 23: ...ration 1 0 mmAl Input power DC 14 8 V Target angle 12 5 Distance to target Distance between target and focal spot 20 cm Main body weight 2 35 kg including back scatter shield Operating temperature 10 40 50 104 Operating humidity 30 75 RH non condensing Atmosphere pressure condition of use 700 1060 hPa Battery type Embedded inside of the main body and not a removable battery type kV fixed 70kV mA f...

Page 24: ...ry is connected 5 Back Scatter Shield A shield that blocks off back scattered radiation 6 Exposure Field Limits the X ray exposure field 7 Trigger Button used to emit radiation 8 Safety Lock Locks the trigger when the device is not in use 9 Handle Helps to hold the device firmly when using the device 10 DC Input Connector Receives power from the charging adapter 11 Input Indicator Lamp Displays th...

Page 25: ...lects parameters and changes its settings 5 Exposure Light Indicates whether the X ray is ready to emit radiation or not Ready Green Emitting Radiation Yellow 6 Battery Status Indicates the current battery level 7 Safety Mode Indicates whether safety mode is on or not 8 Exposure Status Indicator Indicates whether the X ray is ready to emit radiation 9 Selected Setting Indicator Indicates which set...

Page 26: ...ery is fully charged or not 2 Power Charging Jack Supplies DC output power from the adapter 3 Charger Adapter Label Lists the model s name input output conditions certification serial number etc 4 AC Input Connector Connects the AC input of the power cord 5 AC Power Cord Connects external AC power 1 5 4 3 2 ...

Page 27: ...g Lamp Status of whether COCOON is finished charging or not is indicated on the cradle using two different colors red charging green charging complete 3 DC Input Connector Receives charging power from the charging adapter External Battery NO Item Description 1 Output Terminal Jack Supplies DC output power from the external battery 2 Battery Label Lists the model s name input output conditions cert...

Page 28: ...0 User Manual 28 4 Operation 4 1 Switching on the Device 29 4 2 Operating the Control Panel 30 4 3 Positioning 31 4 4 Battery Usage 33 4 5 Settings Menu 38 4 6 Exposure 40 4 7 User Guide 43 4 8 Handle Replacement 45 ...

Page 29: ...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 When the logo disappears the main X ray menu screen will display Sensor Type Patient Type Tooth Type Exposure Time Indicator Battery Status Indicator Safety Mode Indicator Selected Setting Indicator CHECK Fully charge the DX 7020 battery Press the POWER ...

Page 30: ...n Depending on the type of tooth selected the exposure time will change accordingly C Touch the keys to enter the exposure time setting and touch the keys to change the exposure time When the exposure time is changed the tooth type changes accordingly When the device is powered off and then turned back on the most recent settings that were set are displayed D Press the keys simultaneously for thre...

Page 31: ...Positioning the Intra oral Sensor or Film X rays generated by the DX 7020 can be detected by various sensors such as film intraoral sensor digital and PSP phosphor plates Place film or a sensor behind the teeth and hold it with a finger or positioning device to keep the film or sensor from not moving In the case of using film or PSP make sure it s not bent or twisted to avoid distortion of the ima...

Page 32: ...t 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 Press the trigger button to emit radiation when the intraoral sensor and the center of the DX 7020 s cone are placed parallel to the teeth When holding the device it is recommended to grip the handle with one hand and place the other hand on the underside of the trigg...

Page 33: ...e Turn on the device to check if it is operating properly If any problem occurs during troubleshooting see section 5 2 External Battery This battery is an external back up battery It connects to the terminal on the main body at the rear of the machine just behind the main control panel Turn on the device to check if it is operating properly If any problem occurs during troubleshooting see section ...

Page 34: ... between 0 15 please charge the battery If the device is used without charging the battery after the LOW battery indicator is displayed a warning message will pop up on the screen for a few seconds and the device will automatically power itself off Charging the Battery NOTE The battery is tested and fully charged before it is shipped to the factory However the battery should be fully charged befor...

Page 35: ...andle of the main body into the cradle III When the battery is fully charged the battery charging cradle light or the input indicator lamp and DC adapter s LED indicator will turn green NOTE Both the battery charging cradle and DC adapter s LED indicator turns red when the battery is charging Make sure that the external back up battery is not attached when charging the internal battery ...

Page 36: ...cord to the DC adapter II Connect the external battery to the connector gender and then to the DC output connector When the power is connected the DC adapter s LED indicator will turn red III When the battery is fully charged the DC adapter s LED indicator will turn green ...

Page 37: ...cturer will be exempt from any liability CHECK 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 If the battery level ...

Page 38: ...ey To go back to the previous setting screen press the key Power Save time This indicates that the device turns off automatically if not used for the time set The time can be adjusted by using the keys Sound Effect This setting changes what sound the DX 7020 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 ...

Page 39: ...tes after touching the key Firmware Version This shows the current firmware version that is being used Speaker Volume Adjust the speaker volume by touching the keys Powering the Device Off To turn off DX 7020 press the POWER button for one second DX 7020 will turn off automatically if not used for about 5 minutes ...

Page 40: ...ce the film digital intraoral sensor or PSP tightly inside the target tooth 3 Point the main body of the device toward the target tooth and make sure the main body is parallel to the film intraoral sensor or PSP Then press the trigger button 4 When pressing the trigger An audible sound is produced and is followed by a buzzer sound Radiation is only emitted when the buzzer sound emits After radiati...

Page 41: ... goes off while the trigger is being pressed but will stop when the trigger is released DMS method Dead Man Switch CAUTION Emergency shut off Press and hold the power button until the unit shuts off during emergencies CAUTION WATCHDOG DX 7020 is equipped with a safety device that automatically shuts down the product when a dose exceeding the maximum irradiation time of the product is detected to a...

Page 42: ...ENSOR Adult 0 10 0 20 0 20 0 30 0 30 0 40 0 40 Child 0 05 0 15 0 15 0 25 0 25 0 35 0 35 PSP Adult 0 20 0 30 0 30 0 40 0 40 0 50 0 50 Child 0 15 0 25 0 25 0 35 0 35 0 45 0 45 FILM F speed or greater Adult 0 30 0 40 0 40 0 50 0 50 0 60 0 60 Child 0 25 0 35 0 35 0 45 0 45 0 55 0 55 CAUTION Exposure time set depending on tooth type can vary by sensor type whether film is being used distance to patient...

Page 43: ...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 3 The user can change each setting s values by using the keys ...

Page 44: ...P and DX 7020 s cone should be parallel as shown in section 4 3 The tooth being exposed to radiation should be located at the center of the cone This is to get a whole image of the tooth 7 Check the X ray image If the image is distorted try operating the device again by following the guidelines above If there are no issues with the device press the power button for one second to turn off the devic...

Page 45: ...repare the DX 7020 The product must be turned off Separate both parts of the product Slide the switch to the left to remove the handle Prepare the handle for replacement Disassemble by sliding the handle upwards Do not push too hard or the connector may break Insert the handle into the main body ...

Page 46: ... to finish connecting the handle to the body Slide the lock button to the right to secure the handle Check if the device is operating properly What to Look Out for After Replacing the Handle 1 Check if the power turns on 2 Check if the device can emit radiation 3 Check if the battery charges ...

Page 47: ... Model DX 7020 User Manual 47 5 Troubleshooting 5 1 Inspection Checklist 48 5 2 Troubleshooting 49 5 3 Maintenance Schedule 50 ...

Page 48: ...e is no exposure sound when the X ray emits radiation Check the status of the OLED display It should be on Radiation is emitted when the exposure message is displayed on the main menu screen Others DC adapter is not working Check that the DC adapter is connected to the AC power cord Check that the AC power cord is connected correctly to the AC power outlet The Correct input voltage of this device ...

Page 49: ...cian X ray emission works but the image is too bright or completely white Receptor defective Call a qualified service technician The patient is positioned incorrectly Adjust the position of the patient according to the user manual Exposure time is too short Increase the exposure time Device defective Call a qualified service technician X ray emission works but the image is too dark Receptor defect...

Page 50: ...to record the results in the Maintenance Log Sheets located at the bottom of this Section Power button functionality verification Press and hold the power button for one second A power on sound will emit indicating that the device has powered on While the device is on press and hold the power button for one second to turn off the device Please check that the device has indeed turned off Confirm th...

Page 51: ...r to the test detector check exposures using the test detector 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 Test description Acceptance limits Exposure Time ms 50ms 100ms 300ms 500ms 1000ms kVp Accuracy 70kV 10 64 7...

Page 52: ... Model DX 7020 User Manual 52 6 Equipment Specifications 6 1 Technical Specifications 53 6 2 X ray Tube Characteristics Specifications 54 6 3 EMC Data 56 6 4 Product Warranty 59 ...

Page 53: ...fications Item Description High Voltage Generator Model name DXG 7020 Input voltage DC 14 8V Max output power 140 W Rating 70kV 2 0mA X ray Tube D 041 Focal spot 0 4 mm Target angle 12 5 Inherent filtration At least 1 0mmAl Operating tube voltage 70kV ...

Page 54: ...e Voltage 70kV X ray Tube Focal Spot 0 4 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 At least 1 0 mm AL X ray Coverage φ70 mm at SSD 200 mm Anode Heat Content 4300 J Maximum Radiographic Exposure Time 1 2 s Characteristics 1 Tube characteristics ...

Page 55: ... Model DX 7020 User Manual 55 2 Maximum ratings chart 3 Emission Filament characteristics ...

Page 56: ...tallation Mobile RF communications equipment can affect medical devices This device generates uses and can radiate radio frequency energy If not installed and used by following the instructions listed in this manual it may cause harm to other devices in its vicinity However there is no guarantee that interference will not occur during a particular installation Whether this device causes harm to ot...

Page 57: ... 10m dbuv m Margin dbu v Value 1000 H V 2 0 30 1 32 1 37 4 9 Emission test Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 DX 7020 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment RF emissions CISPR11 Class B The DX 7020 is suitable for all establishments in...

Page 58: ...Field Contents Radiation field Frequency range Field strength Modulation Frequency step 80 2500 MHz 3 V m 10 V m AM 80 1 kHz sine wave 1 3 step Magnetic field Test frequency Field level EMF Duration Axis of orientation 50 Hz 3 A m 60 seconds each axis X Y Z axis ...

Page 59: ... recommend replacing the battery every year or at least every two years Failure to do this will result in excessive heat or damage to the internal components of the DX 7020 Failure by the customer to replace the battery during the recommended time interval will exempt Dexcowin from any product liability for any accidents caused by battery failure Failure to use the correct supplied battery adapter...

Page 60: ... Model DX 7020 User Manual 60 LOCATIONS Korea HQ 901 905 25 Gasan digital 1 ro Geumcheon gu Seoul 08594 South Korea Tel 82 2 3402 5500 Fax 82 2 3402 5539 ...

Page 61: ... Model DX 7020 User Manual 61 901 905 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 ...

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