Dexcowin COCOON DX-7020 User manual

USER MANUAL
Model: DX-7020
Manual Version: 1820.8

(Model: DX-7020) User Manual
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More Safe
More Convenient
More Durable

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Table of Contents........................................................................................................................................3
1 General Information.....................................................................................................................................4
1.1 Notice...................................................................................................................................................5
1.2 Manufacturer & User Obligations.........................................................................................................6
1.3 Symbols ................................................................................................................................................7
1.4 Standards & Classifications..................................................................................................................11
2 Safety Precautions ..................................................................................................................................... 13
2.1 Radiation Safety .................................................................................................................................. 14
2.2 Cleaning Safety ................................................................................................................................... 15
2.3 Storage & Transportation ................................................................................................................... 16
2.4 General Warnings/Checks/Cautions.................................................................................................. 17
3 Getting Started .......................................................................................................................................... 19
3.1 Intended 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 Schedule........................................................................................................................50
6 Equipment Specifications ...........................................................................................................................52
6.1 Technical Specifications......................................................................................................................53
6.2 X-ray Tube .........................................................................................................................................54
6.3 EMC Data............................................................................................................................................56
6.4 Product Warranty ...............................................................................................................................59
Table of Contents

(Model: DX-7020) User Manual
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1 General Information
1.1 Notice 5
1.2 Manufacturer & User Obligations 6
1.3 Symbols 7
1.4 Standards & Classifications 11

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1.1 Notice
The DX-7020 is a portable, handheld dental X-ray device.
This is a diagnostic device that can be used on pediatric and adult patients. It’s designed for
taking diagnostic intraoral dental X-rays using conventional film (F-speed or greater film),
PSP (Phosphor plates), or digital sensors. This device is indicated for use by only trained and
qualified dentists or dental technicians.
This manual contains instructions, procedures, technical 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 covered in this manual and any incidents concerning the device,
please report it to the manufacturer at:
DEXCOWIN CO., LTD.
Email: [email protected]
Phone: [phone]
Fax: [phone]
Version: 1820.8
Model: DX-7020
Country: EU (EN)
Initial Date: 03-10-2017
Rev. Date: 11-03-2022

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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:
▪Approved replacement parts are used.
▪Maintenance and repairs are performed by an authorized distributor/ manufacturer.
▪This equipment is used correctly according to the user manual.
▪Equipment damage or malfunction is not the result of an error on the part of the user.
RADIATION HAZARD
This X-ray 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 and electrical
components of this equipment to ensure safe and consistent operation (IEC 60601-1).
The owner of this equipment must follow the safety precautions and troubleshooting outlined
in this manual.
CAUTION
Please do not operate this device before reading the manual and its
related materials.

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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
HAZARD
Indicates a possible danger to users
due to exposure to radiation.
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
Indicates that the contents of the
transported package can be damaged
and should be handled with care.
THIS SIDE UP
Indicates which side of the
transported package should face
upward.

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Symbols used on the device
ELECTRICAL
PROTECTION
Indicates Insulated patient
application (Type B).
RADIATION
HAZARD
Indicates a radiation hazard.
CAUTION
Indicates a hazard.
REFER TO
DOCUMENTS
Refer to the user manual and other
accompanying documents.
MANUFACTURER’S
INFORMATION
Indicates the name and address of
the manufacturer.
DATE OF
MANUFACTURE
Indicates the device’s manufacture
date in the form MM-YYYY.
SERIAL NUMBER
This symbol houses the device’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
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
CE
CERTIFICATION
This symbol indicates the CE
notified Body.

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1.3.1 Label Locations
1. Generator Label (located inside)
2. Charging Cradle Label
3
4
2
5

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3. Adapter Label
4. Main Label

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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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Classifications
Protection against the ingress of water: Ordinary Equipment (IPX0)
Protection 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.

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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

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2.1 Radiation Safety
RADIATION
HAZARD
➢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.
➢X-ray operators must pay attention to the status of patients in
case of emergency.
➢X-ray operators must stop operating the device if a problem is
detected.
Diagnostic Reference Level
CHECK
Procedure
Approx.
effective
radiation dose
Comparable 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
Radiograph
Standard dose for each 5year old patient
[Unit: mSv]
Dental:
Orthopantomogram
0.014
Dental: Intraoral
0.008
Reference sites:
https://www.westmetrokidsdental.com/digital-dental-x-rays-and-your-
child/
http://www.imagegently.org/Procedures/Digital-Radiography
http://www.fda.gov/Radiation-
EmittingProducts/RadiationEmittingProductsandProcedures/MedicalIm
aging/ucm298899.htm

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2.2 Cleaning Safety
CAUTION
➢Power off or remove the power supply from the base before
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

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2.3 Storage & Transportation
WARNING
➢To prevent unauthorized use, DX-7020 must be stored securely
when not in use.
CAUTION
➢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.
➢Do not use the device close to heaters and heating devices.
➢Do not disassemble. If the seal attached to the product is damaged
or removed, repair services may not be covered under warranty.
➢Regular 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 locations with high humidity or direct sunlight when
storing the device.
➢Avoid locations with lots of dust, slope, and dirt when storing
the device.
➢Transportation and storage conditions:
-Transportation and storage temperature: -25 ~ 40 ℃(-13 ~
104℉)
-Transportation and storage humidity: 10 ~ 95 %
-Transportation and storage atmosphere pressure: 500 ~
1060hPa

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2.4 General Warnings/Checks/Cautions
WARNING
➢Do not modify the device without authorization from the
manufacturer.
➢When using the device, if radiation exposure safety regulations
and operation-related guidelines are not followed, both patients
and operators can be at risk.
➢Only an authorized skilled technician or person can operate this
device.
➢Please use this device only for its designated purposes.
➢When using this device, if any problems are detected, please
stop using the device to ensure the safety of the patient.
➢Please do not modify or alter the device during operation.
➢Make sure a fire extinguisher is on-site in case a fire-related
emergency occurs.
➢Patients with pacemakers may have their pacemakers
malfunction when being exposed to radiation.
➢To avoid electrical shock, do 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 the device falls, it may harm the user or damage the
device.
➢Do not store the device in a vehicle or any place where it could be
easily stolen or improperly used. If the device must be stored in
those locations, take precautions to ensure it is stored safely.
➢Please be sure not to exceed the required exposure time for image
diagnosis.
➢Handle the device with care; do not use sharp objects or severely
damage the device. Follow the instructions carefully and use the
device for recommended applications only.
➢Use the device only in the environments recommended, which
take into account temperature, humidity, and pressure.

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CHECK
➢Read the user manual before operating the device for proper
usage.
➢Double-check parts of the device that comes in direct contact
with patients.
➢Use the device with a designated sequence with minimum
exposure to get quality diagnostic images.
➢Use the device at a clean location with good ventilation.
➢Clean the device with a dry cloth. Do not expose the device to any
liquids.
➢Regularly inspect the device to see if it is operating properly.
➢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.
➢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 supply and inform the service center.
➢When discarding the device, since the device is an electrical and
electronic product, it must be collected separately and be
discarded in compliance with the Waste Electrical and Electronic
Equipment (WEEE) Directive. This symbol indicates that
electrical and electronic equipment wastes must not be disposed
of 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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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

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3.1 Intended Use/ Prohibited Use
DX-7020 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.
Prospective User 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 diagnostic medical radiation devices affect treatment and
diagnosis of dental diseases
How radiation emitting diagnostic devices operate
The contents of the user manual.