the portable handheld dental x-ray system (product name:...

1

The Portable Handheld Dental X-RAY System (Product Name: COCOON) is indicated for

use only by trained and qualified dentists or dental technicians. This is a diagnosis device

that can be used on pediatric and adult patients, designed for taking diagnostic intraoral

dental X-rays using conventional film, PSP (Phosphor plates) or digital sensors. It is

powered by DC adapter or Internal or External battery for a hand-held use.

1. Do not operate this device until you read and review the

accompanying this user manual completely.

2. See the Certificate of Conformance accompanying your device. COCOON also

complies with DHHS Radiation Performance Standard, 21CFR Subchapter J.

3. COCOON is a trademark registered by Dexcowin Co., Ltd in Korea and other

countries. All right reserved.

2

Symbols used in this Manual

SYMBOL NAME DETAIL

Radiation warning “Radiation Warning” sign explains details of possible

user radiation hazard.

Warning "Warning" sign explains details of possible user

damage, death or physical damage.

Caution "Caution" sign explains details of possible body

damage due to incorrect use of the product.

Check

"Check" sign explains details of necessary items that

users should follow in product installation, operation,

and maintenance.

Symbols marked on the packaging of COCOON

SYMBOL NAME DESCRIPTION / FUNCTION

Keep away from rain This symbol means that transport package shall

be kept away from the rain.

Fragile

This symbol means that contents of the

transport package are fragile therefore it shall

be handled with care.

This way up This symbol means that indicates the correct

upright position of the transport package.

3

Symbols marked on COCOON

SYMBOL NAME DESCRIPTION / FUNCTION

Electrical protection Insulated patient application(Type B).

Radiation warning This symbol indicates radiation hazard.

Warning This symbol indicates a hazard.

Consult

accompanying documents

This symbol advises the reader to consult the

accompanying documents.

Manufacturer information

This symbol is followed by the name and

address of the device manufacturer.

Manufacture date

This symbol is followed by the device

manufacture date in the form YYYY-MM.

Serial number This symbol is followed by the device serial

number.

Representatives

information The manufacturer’s EU representative

information shows with this symbol.

Separate collection of electrical and

electronic equipment

Indicates the need for separate collection for

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

4

TABLE OF CONTENTS

TABLE OF CONTENTS ................................................................................................................ 4

1 GETTING STARTED ........................................................................................................... 7

1.1 INTENDED USE/ PROHIBITION OF USE ............................................................................................................. 7

1.2 UNPACK AND CHECK COCOON ..................................................................................................................... 7

1.2.1 Product composition .................................................................................................................................................... 7

1.2.2 Preliminary Checks ......................................................................................................................................................11

1.3 PRODUCT FEATURES .......................................................................................................................................... 12

1.3.1 Features ............................................................................................................................................................................12

1.4 PRODUCT SPECIFICATIONS ............................................................................................................................... 13

1.4.1 Device main body .......................................................................................................................................................13

1.4.2 Charger specification .................................................................................................................................................14

1.4.3 Battery charging cradle .............................................................................................................................................14

1.4.4 Each part name of main body...............................................................................................................................15

1.4.5 DC adaptor & cord .....................................................................................................................................................17

1.4.6 Battery charging cradle (Applicable only to Model: DX-7017) ..............................................................18

1.4.7 External Battery (Applicable only to Model: DX-7020) ..............................................................................18

1.5 CHARGING THE BATTERY .................................................................................................................................. 19

2 SAFETY PRECAUTIONS ..................................................................................................21

2.1 RADIATION SAFETY ............................................................................................................................................ 21

2.2 CLEANING ............................................................................................................................................................ 25

2.3 SECURITY, STORAGE, AND TRANSPORTATION .............................................................................................. 26

2.3.1 Storage .............................................................................................................................................................................26

2.3.2 Check for Product storage ......................................................................................................................................27

2.3.3 Transportation and Storage conditions ............................................................................................................27

3 WARNING / CAUTION AND INSTRUCTIONS ...........................................................27

3.1 WARNING AND INSTRUCTIONS ....................................................................................................................... 27

3.1.1 Warning for product use .........................................................................................................................................27

3.1.2 Warnings for Product inspection .........................................................................................................................27

5

3.2 CAUTION AND INSTRUCTIONS ......................................................................................................................... 28

3.2.1 Caution for product use ...........................................................................................................................................28

3.2.2 Caution for storage.....................................................................................................................................................28

3.2.3 Caution for other matters ........................................................................................................................................29

4 ITEMS TO CHECK ............................................................................................................29

4.1 ITEMS TO CHECK ................................................................................................................................................ 29

5 SETUP AND CHECK ........................................................................................................30

5.1 THE BACK SCATTERED SHIELD ......................................................................................................................... 30

5.1.1 Performance of back scattered shield ...............................................................................................................30

5.2 NOT REMOVABLE BATTERY (APPLICABLE ONLY TO MODEL: DX-7017) ................................................. 31

5.3 EXTERNAL BATTERY (APPLICABLE ONLY TO MODEL: DX-7020) .............................................................. 31

5.4 CHECKING FOR POWER AND BATTERY CHARGE STATE .............................................................................. 32

5.5 BASIC FUNCTION CHECKS ................................................................................................................................ 32

6 OPERATION ......................................................................................................................33

6.1 POWERING UP .................................................................................................................................................... 33

6.2 CHECKING THE BATTERY CHARGE ................................................................................................................... 34

6.3 POWERING OFF .................................................................................................................................................. 35

6.4 EXPOSURE TECHNIQUES ................................................................................................................................... 35

6.4.1 Patient's positioning ...................................................................................................................................................35

6.4.2 Film or intraoral sensor positioning ...................................................................................................................35

6.4.3 COCOON positioning ................................................................................................................................................36

6.5 CONTROL OF COCOON ................................................................................................................................. 37

6.5.1 Main control screen composition ........................................................................................................................37

6.5.2 Main control screen....................................................................................................................................................37

6.5.3 Setting the Exposure Time ......................................................................................................................................39

6.5.4 X-RAY exposure ............................................................................................................................................................39

6.5.5 X-RAY parameter set..................................................................................................................................................41

6.5.6 Screen setting ................................................................................................................................................................42

7 QUICK USER GUIDE ........................................................................................................43

8 INSPECTION ITEMS BEFORE REPAIR REQUEST ........................................................46

8.1 CHECK ITEMS BEFORE REQUESTING INSPECTION .......................................................................................... 46

6

8.2 TROUBLESHOOTING ........................................................................................................................................... 47

8.3 MAINTENANCE SCHEDULE ................................................................................................................................ 48

8.3.1 On-going check ............................................................................................................................................................48

8.3.2 Annual User Check ......................................................................................................................................................48

8.3.3 Annual Calibration .......................................................................................................................................................50

8.3.4 Maintenance Log Sheet ............................................................................................................................................51

9 TECHNICAL DESCRIPTION ............................................................................................52

9.1 BASIC TECHNICAL SPECIFICATIONS ................................................................................................................. 52

9.2 HIGH VOLTAGE GENERATOR ............................................................................................................................ 53

9.2.1 X-ray Tube Specifications and Characteristics ...............................................................................................53

9.3 EMC DATA ......................................................................................................................................................... 55

9.3.1 Electromagnetic interference .................................................................................................................................56

MANUAL VERSION 1.1

Revision date: October/2017 File number: IFU-07

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1 Getting Started

1.1 Intended Use/ Prohibition of use

COCOON is designed for experienced dentists and dental technicians to use for both

adult and pediatric patients to produce diagnostic X-ray images.

COCOON is prohibited for use on patients who known to be or possibly pregnant.

1.2 Unpack and Check COCOON

1.2.1 Product composition

COCOON consists of the item below.

DX-7017

Main body: 1EA

Battery(Lithium Polymer Battery) is embedded inside of main body not removable

DC adapter & Power cord: 1SET

Battery charging cradle: 1EA

User Manual (include product warranty certificate): 1EA

Back Scattered shield: 1EA

Wired remote control switch (Optional): 1EA

Neck strap: 1EA

8

Main body

Battery charging cradle

DC adaptor & Power cord

Neck strap

Back scattered shield

User Manual & Warranty

Certificate

Wired remote controller

(Optional)

Figure 1.1 Product Compositions (DX-7017)

9

DX-7020

Main body: 1EA

External Lithium Polymer Battery: 1 EA

Cradle

Battery charging DC adapter & Power cord: 1SET

User Manual (include product warranty certificate): 1EA

Back Scattered shield: 1EA

Wired remote controller (Optional): 1EA

Neck strap: 1EA

PSU (Power Supply Unit) to the wall (Optional): 1EA

10

Figure 2.2 Product Compositions (DX-7020)

Main body

External Lithium Polymer

Battery Cradle

Neck strap

DC adaptor & Power cord Back scattered shield

User Manual & Warranty

Certificate

Wired remote controller

(Optional)

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1.2.2 Preliminary Checks

Item Check

Device Labels As shown in Figure 1.2 below, make sure that the label is

attached to the device in place.

Other Labels Make sure that the serial number on the Warranty matches the

device serial number and the device carrying case serial

number.

Collimator cone Inspect for damage. The lead lining must cover the entire

interior surface.

Trigger switch Should move freely in when depressed and out when released.

Control panel Should be smooth and free of scratches, damage or nicks

Label-Outside (applicable to both Model: DX-7017, DX-7020)

○1 E

A Model: DX-7017 A○2 E

A Model: DX-7020

Figure 1.2 labeling on Main Body

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Inside: X-ray tube assembly

1.3 Product Features

1.3.1 Features

Medical Device Name: Portable Handheld X-RAY System

Product Name: COCOON

Model Name: DX-7017, DX-7020

Display: 3.12” OLED (Resolution: 256 x 64)

Function for user

- Exposure time setup in accordance with adult and child or type of the teeth

- OLED screen brightness control function

- Intuitive Graphic User Interface

- Radiation Exposure Interval Setting Function

- Trigger use

- Automatic Shut Down

Designed for user's wrist protection

Figure 1.3 Labeling on X-ray tube assembly

○1 Model: DX-7017 ○2 Model: DX-7020

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1.4 Product specifications

1.4.1 Device main body

COCOON Main Body

Model Name DX-7017 DX-7020

X-RAY tube focal spot size 0.4 mm

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 14.8 VDC

Target Angle 12.5˚

Distance to target Distance between target and Focal Spot > 20 cm (8 inches)

Main body weight 2.3 kg (Exclusion Back scattered shield)

Operating temperature 10 - 40℃

Operating humidity 30-75% RH, non-condensing

Atmosphere pressure

condition of use 700 ~ 1060 hPa

Battery Type Embedded inside of main body, not

removable battery type External battery type

kV (fixed) 70kV 70kV

mA (fixed) 1.7mA 2.0mA

Power consumption 350 W 350 W

Exposure time 0.05~1.0sec 0.05~1.0sec

Exposure time setting

interval 0.01 sec 0.01 sec

COCOON LEFT COCOON BACK COCOON TOP COCOON FRONT

Figure 1.4 COCOON drawing

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1.4.2 Charger specification

Model name: BPL910S16F01

Input: AC 100-240[V], 50/60 [Hz], 0.5 [A]

Output Voltage: DC 16.8 [V]

Output Current: 1.0 [A]

1.4.3 Battery charging cradle

Model name:

Charging voltage: DC 16.8 [V]

Charging current: 1.0 [A]

Discharging voltage (at the time of battery connection): vary depending on

discharging condition

Discharging current (at the time of battery connection): vary depending on

discharging condition

Size: 270(L) x 132(W) x 195(H)

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X-ray field

Power On/Off Button

Trigger

Safety lock

Exposure lamp

256 x 64 pixel OLED screen

Swing able strap hook ring

X-ray mode control

Handle

1.4.4 Each part name of the main body

Each part name of the main body is as follows.

A○1 E

A DX-7017

Figure 1.5 Each part name of main body (DX-7017)


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X-ray mode control

X-ray field

A○2 E

A DX-7020

Figure 1.6 Each part name of main body (DX-7020)


Swingable strap hook ring

Power On/Off Button

256 x 64 pixel OLED screen

Exposure lamp

Trigger

Safety lock

Handle

Output jack connector

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1.4.5 DC adaptor & cord

The part name of the charger is as shown in Figure 1.6.

Inside: X-ray tube assembly

Charging power jack: supplies DC output power from the adapter.

Output indicator lamp: displays the current output status.

AC input connector: connects the AC input of the power cord.

Charging adapter label: lists the model name, input/output conditions, certification, serial

number, and so on.

AC power cord: connects external AC power.

Figure 1.7 Part name of DC adaptor part

(top)

AC power cord

(BOTTOM)

Label

AC POWER SOCKET

Charging power jack

Output indicator lamp

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Charging terminals

DC input connector

Charge indicating lamp

1.4.6 Battery charging cradle (Applicable only to Model: DX-7017)

① The name for each part on charging cradle

Charge indicating lamp: Indicates each status of charging or charge completion by

different colors.(red: charging, green: charge completion, yellow: charge error)

Charging terminals: connect the output terminal of the battery pack to charging terminals

of charging cradle and charge the battery.

Battery pack holder: prevents the battery pack from being dispatched when connecting the

battery pack to charging cradle.

DC input connector: receives charging power from charging adaptor

1.4.7 External Battery (Applicable only to Model: DX-7020)

Charge terminal: connect charging power jack of DC adaptor to charge terminal of the

external battery. Then the external battery is charged.

Output terminal jack: supplies DC output power from the external battery. It's length over

than 14.5 inches.

Battery pack holder

Figure 1.8 The part name of charging cradle

Output terminal jack

Battery label

Battery state LED

Charge terminal

Figure 1.9 The part name of external battery

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③ When charging is finished, battery

charging cradle's and DC adapter's LED

indicator turns on green.

Battery label: lists the model name, input/output conditions, certification, serial number, and

so on.

Battery state LED: indicates each status of charging or charge completion by different colors

(red: charging, green: charge completion)

1.5 Charging the Battery NOTE: The battery is tested and fully charged for shipping at the factory. However, the battery is to

be fully charged prior to initial use to prevent function damage of battery or discharged to lower

level in the case unused stored for a long time period such as three(3) months.

DX-7017

① Connect the AC power cord to the AC socket on the charger.

② Connect the DC output connector to the cradle.

③ Put handle of the main body to the cradle.

④ Connect the AC power cord to a power outlet rated AC 100-240[V], 50-60[HZ].

⑤ Battery charging cradle's and DC adapter's LED indicator turns on the red when

power is connected.

⑥ When charging is finished, Battery charging cradle's and DC adapter's LED indicator

turns on the green.

② Connect the DC output connector to the cradle

then put handle of the main body to the cradle.

Figure 1.10 Charging the battery (DX-7017 IN)

① Connect the AC power cord to

the charger.

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③ When charging is finished, External

battery's and DC adapter's LED indicator

turns on green.

DX-7020

A○1E

A Connect the AC power cord to the AC socket on the DC adapter

A○2E

A Connect the DC output connector to the External battery

③ Connect the AC power cord to a power outlet rated AC 100-240[V], 50-60[HZ]

④ External battery's and DC adapter's LED indicator turns on the red when power is

connected

⑤ When charging is finished, External battery's and DC adapter's LED indicator turns

on the green

① Connect the AC power cord to

the DC adapter.

② Connect the DC output connector to

the external battery. When power is

connect DC adapter's and External

battery's LED indicator turns on red.

Figure 1.11 Charging the battery (DX-7020 EX)

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2 Safety Precautions

2.1 Radiation Safety

X-ray equipment for Dental Intra-oral radiography DX-7020 and DX-7017 complies

with 21CFR Subchapter J, IEC60601-1-3, IEC60601-2-28, IEC60601-2-65, which

these are regulations on radiation safety and protection.

X-ray operator must be placed behind main body's backscattered shield.

Do not expose the x-ray if anyone else is in the same room unless it is necessary

that the patient be accompanied by another person. If necessary that be

accompanied by another person, that person must then stay out of the direct beam

and wear protective clothing (e.g., lead apron).

X-RAY operator must pay attention to the status of a patient in case of emergency.

X-RAY operator must stop operating if the disorder is detected.

A pregnant or expect to become pregnant woman and child must be advised prior

to X-RAY operation.

Diagnostic Reference Level

Following are comparisons of effective radiation dose with background radiation

exposure for several radiological procedures.

WARNING This X-ray unit could be dangerous to the patients or the operators unless

safe exposure factors, operating instructions and maintenance schedule are

observed.

22

Table 2-1. Diagnostic Reference Level

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

Table 2-2. Diagnostic Reference Level in Pediatrics

Diagnostic in Pediatrics

Reference site: http://www.imagegently.org/Procedures/Digital-Radiography

http://www.fda.gov/Radiation-EmittingProducts/

RadiationEmittingProductsandProcedures/MedicalImaging/ucm29

8899.htm

Principles of Radiation Protection

The FDA recommends that imaging professionals follow two principles of radiation protection

of patients developed by the International Commission on Radiological Protection.

For this procedure

* Approximate Effective Radiation

Does

Comparable to Natural Background Radiation Period of

** Additional Lifetime risk of Cancer from

Examination

BONE

Radiography (X-ray)-Spine 1.5 [mSv] 6 [months] Very Low

Radiography (X-ray)-Extremity 0.001 [mSv] 3 [hours] Negligible

DENTAL

Intraoral X-ray 0.005 [mSv] 1 [day] Negligible

Radiograph 5-year old patient, Reference Dose Entrance Surface Dose

per SINGLE VIEW. [Unit: μGy]

Skull AP 1500

Skull LAT 1000

http://www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray

http://www.imagegently.org/Procedures/Digital-Radiography

http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm

23

1. Justification: The imaging procedure should be judged to do more good than harm to the

individual patient. Therefore, all examinations using ionizing radiation should be performed

only when necessary to answer a medical question, treat a disease, or guide a procedure. The

clinical indication and patient medical history should be carefully considered before referring a

patient for any x-ray examination.

2. Optimization: X-ray examinations should use techniques that are adjusted to administer the

lowest radiation dose that yields an image quality adequate for diagnosis or intervention (i.e.,

radiation doses should be "As Low as Reasonably Achievable"(ALARA)). The equipment used

should be designed for pediatric use; the technique factors used should be chosen based on

the clinical indication, patient size, and anatomical area scanned; and the equipment should be

properly maintained and tested.

How Much Radiation is a Child Exposed to during Dental Radiography?

Every day we are exposed to small amounts of radiation from our environment. This radiation

comes from outer space, the ground, building materials, air, and water. This is called natural

background radiation. The amount of this radiation to which we are exposed depends upon

where we live. For example, those who live in higher elevations (such as Denver, Colorado) are

exposed to more radiation from outer space than people who live at sea level. To minimize the

amount of radiation used to create a dental image, the settings on the X-ray device should be

adjusted depending upon the child’s size. The millisievert (mSv) is a measure of effective

radiation dose to the body. One way of assessing the dental radiation risks is to compare the

radiation doses that result from dental images with estimates of equivalent amounts of natural

background radiation

Table 2-3 Comparison of Radiation effective Dose from various dental and

Medical image procedures to natural background radiation

Estimated effective dose Equivalent Amount of Background Radiation

Natural back ground

radiation 3 mSv/yr

1 Panoramic X-ray Up to 0.02 mSv Up to 3 days

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What are the Risks to a Child from Radiation from Dental Radiography?

There is no conclusive evidence that radiation from dental diagnostic x-rays causes cancer.

However, major national and international organizations responsible for evaluating radiation

risks agree that we should act as if even low doses of radiation may potentially cause harm

and should always try to minimize radiation exposure. This is particularly important in children

as they are at an approximately 3 to 5 times higher radiation-induced cancer mortality risk

than adults. This is because their developing tissues are inherently more radiosensitive and

because they have more remaining years of life during which a radiation-induced cancer could

develop.

It is estimated that approximately 1 in 1,000 individuals will develop cancer from an exposure

of 10 mSv. Therefore a relative radiation level (RRL) can be provided when considering the risk

for a single x-ray exposure or a course of treatment involving multiple images.

Table 2-4 Relative radiation level (RRL) designations for children and adults

Despite several limitations of estimating radiation dose risk, comparison of the radiation

Effective Dose from various dental Imaging Procedures (Table 2-3) to the RRL (Table 2-4)

shows that for children all dental radiographic procedures have minimal risk.

4 bitewing X-rays Up to .005 mSv Up to 0.6 day

Cephalometric X-ray Up to .006 mSv Up to 1 day

Chest X-ray (single view) Up to 0.01mSv 1 day

Chest X-ray (2 view) Up to 0.1 mSv 10 days

Relative Radiation level Effective Dose Estimate Range (mSv)

Adult Child

None 0 0

Minimal <.1 <.03

Low .1-1 .03-.3

Medium 1-10 .3-3.0

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How can Radiation Risk to a Child be minimized?

The Image Gently Campaign provides guidance to dental practitioners to minimize radiation

exposure to children. These involve numerous strategies and include:

• Only perform imaging when there is a clear medical or dental benefit to the child.

• Use the lowest amount of radiation for adequate imaging based on the size of the child.

• Only take images on the indicated area and always using the thyroid collar

• Avoid multiple unnecessary images.

• Use alternative diagnostic studies (such as ultrasound or MRI), if possible.

If no abnormality is detected with a dental image does this mean the image was

unnecessary?

Dental x-ray images should be considered only after a thorough clinical examination of the

child. Dental images are taken either to confirm a clinical suspicion of a certain condition or to

eliminate it from further consideration. In the latter case the dental image does not provide a

positive result but is of value in that it may avoid additional tests or procedures.

Encourage dentist/ dental technician

• Select x rays for individual's needs, not merely as a routine

• Use the fastest image receptor possible: E- or F-speed film or digital sensors

• Always use thyroid collars

• Child-size the exposure time

2.2 Cleaning

Power off or separate power supply before cleaning.

Before cleaning the battery charger, make sure that the battery charger is unplugged.

Clean the external surface using a damp cloth and non-oil based detergent and non-

aggressive medical detergent. The spacer cone may be cleaned with cotton wool

soaked with surgical alcohol.

26

2.3 Security, Storage, and Transportation

To prevent unauthorized use, COCOON should be stored securely when not in use.

If you have finished using COCOON, keep it in a separate place to prevent

unauthorized use.

2.3.1 Storage

Store the device in a safe place for access by a qualified person.

The X-RAY section that is in direct contact with the patient should be cleaned with

rubbing alcohol frequently.

Do not use near heaters or heating devices.

Please keep in storage after use.

Do not randomly convert. If SEAL attached to the product is damaged, A/S is not

provided free of charge.

Use device and parts safely after performing regular check-up at designated A/S

center only.

Avoid following places for storage and use of device.

- Place with lots of moisture

- Place with direct sunlight

- Place with lots of dust

- Place with high humidity

- Place with no ventilation

- Place with lots of saltiness

- Place with chemical substance or explosive gas

CAUTION Turn off the device before carrying out cleaning operations.

Do not spray products directly on the device. Apply the product on a clean

cloth.

27

2.3.2 Check for Product storage

Avoid place with high humidity or direct sunlight when storing.

Avoid place with lots of dust, slope, and dirt when storing.

Do not store in place with extreme temperatures.

2.3.3 Transportation and Storage conditions

Transportation and storage temperature: -25 ~ 60 ℃

Transportation and storage humidity: 10 ~ 95 %

Transportation and storage atmosphere pressure: 500 ~ 1060hPa

3 Warning / Caution and instructions

3.1 Warning and instructions

3.1.1 Warning for product use

Do not modify the device without the authorization of the manufacturer.

When using Device, if radiation exposure safety regulations and operation related

guidelines are not followed, both patients and operators can be at risk.

Only authorized skilled technician or person can operate this device.

Please use this device only for a designated purpose.

When using this device, if any abnormalities are found with the patients, please

stop using the device, and ensure the safety of patients.

Please do not randomly alter the device while using.

Make sure fire extinguisher is onsite in case of fire-related emergencies.

Patients with pacemakers may experience a malfunction.

3.1.2 Warnings for Product inspection

28

Do not touch the product, power supply, or plug with wet hands to avoid electrical

shock.

When cleaning the product, please separate the device from a power outlet and

clean it with dry clothes.

3.2 Caution and instructions

3.2.1 Caution for product use

Please ensure not to exceed X-RAY exposure required for image diagnosis.

Handle the device with care; do not use a sharp object or cause a severe impact on

the device. Follow the instruction carefully and use for recommended applications.

Use only at the recommended temperature, humidity and pressure.

Do not let the device get wet or be exposed to liquids.

3.2.2 Caution for storage

Moisture, salinity, dust and etc. can affect the performance of device. Do not store

device in places with such conditions.

Do not store 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 could be shrunk, swollen, frozen, or overheat

causing critical damages to device function.

Do not store product together with explosive gas or chemicals.

The device must be stored in protection case. When being damaged physically at

the unsafe place, it may cause critical damages to device function.

Do not place the device on a high shelf or any narrow place. If the device falls, it

may be damaged or harm the user.

29

Do not store the device in the trunk of a car or at cargo van of the vehicle. If the

device must be stored in those locations, ensure it is tightly secured.

3.2.3 Caution for other matters

In case of device breakdown, mark properly and leave it to designated professional

at A/S center

Do not let patients touch the device at their own risk.

If the device is dropped, do not turn it on. Detach power supply and.

When discarding product,

Indicate the need for separate collection for electrical and electronic

product 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

4 Items to check

4.1 Items to Check

Read user manual before operating the device for proper usage.

Double check the part of the device that directly contacts patients.

Use device with the designated sequence.

Use device at a stable location with good ventilation.

Clean the device with a dry cloth. Do not wet the device.

Regularly inspect device for malfunctions.

30

5 Setup and Check

5.1 The Backscatter shield

5.1.1 Performance of backscatter shield

Figure 5.1 indicates the scattering radiation area which is changed using back

scatter shield.

The back scattered shield limits scattering radiation area to the intended target.

Patient

Scattering radiation area Scattering

Radiation Area

Back Scatter Shield

Scattering radiation area

without back scattered shield

Scattering radiation area

with back scattered shield

Patient

Figure 5.1 Comparison of Scattering Radiation Areas, with and without use of

Back Scattered Shield

Patient Patient Patient

31

5.2 Not removable battery (Applicable only to Model: DX-7017)

COOCON’s (Model: DX-7017) battery type is not removable battery.

The battery is embedded and not removable from the main body.

Turn on the power to check that the device is working properly.

If it occurred troubleshooting, see section 7.1.

5.3 External Battery (Applicable only to Model: DX-7020)

COCOON’S (Model: DX-7020) battery type is the external battery.

Connect the external battery output terminal to main body's external terminal

connector.

Turn on the power to check that the device is working properly.

If it occurred troubleshooting, see section 7.1.

Figure 5.2 Not removable battery type

Figure 5.3 External battery type

32

5.4 Checking for Power and Battery Charge State

① After fully charging the battery, press and release the POWER button. The OLED display

should illuminate, accompanied by a single audible signal.

② Check the battery level indication and remaining battery level on the upper right of the

main screen.

③ As the battery is low, it would be warned by a buzzer, low battery indicator lamp on

OLED window or warning sound.

④ If battery level gets low, It needs to be charged before use.

5.5 Basic Function Checks

COCOON is calibrated at the factory and tested prior to shipping out. There are no adjustment

options.

① ON/OFF button: Fully charge the COCOON battery. Press the POWER button to check the ON

and OFF button status.

② Increase/Decrease touch panel (Up and Down Arrows): With the device on, press the Increase

and Decrease touch panel to check that

the exposure time displayed on the OLED

display changes appropriately.

③ Automatic Shut-Off: Press the power button to turn the device on and wait for about 3 minutes

until it turns off automatically if it is not in use.

33

Power On/Off button

Selection panel

Direction panel: up/down/left/right

6 Operation

6.1 Powering up

Name for each button on top side of COCOON is shown in figure 6.1

.

After pressing the power button on the top of the main body for 2 seconds, a green

light should appear around the button, along with buzzer sound. The display should

turn on with manufacturer's logo as pictured in Figure 6.2.

Figure 6.2 Manufacturer logo

After logo disappears, Main(X-ray) control screen will be displayed.

Figure 6.1 Name for Each part on top side button and panels

Exposure lamp

34

6.2 Checking the battery charge Low battery will be indicated by a buzzer sound, OLED screen, Low battery indication

lamp and battery warning sound when power is on.

When the battery is replaced during operation, the battery level of the OLED screen

indicates 'LOW' and low battery image is displayed on the upper right of the main

control screen. Also, the battery replacement indicator lamp on the top of the device

flashes amber(Applicable only to Model: DX7020 EX)

The battery level displays on the upper right side of the main control screen are shown

in Figure 6.3. When the battery level is between 0 ~ 15%, please charge the battery.

If the device is used without charging the battery even after the 'LOW' battery indicator is

displayed, the battery warning massage shown in Figure 6.4 appears on the OLED screen for a

few seconds and then the device is forcibly turned off.

Figure 6.4 OLED screen Indicating Low Battery

Figure 6.3 Battery level indication

35

6.3 Powering off

TO turn off COCOON, press down the POWER button for two seconds. (COCOON will turn off

automatically if not used for about 3 minutes.)

6.4 Exposure Techniques

6.4.1 Patient's positioning

Place patient as bilateral symmetry to the chair.

Make sure patient's head is fixed.

It is recommended to set exposure position about 15~30 ˚ from patient's position,

but the degree and position can be adjusted according to the user's convenience.

However, the patient should not move while exposed.

6.4.2 Film or intraoral sensor positioning

X-rays generated by COCOON can be detected by various detectors such as film,

the intraoral sensor (digital) and PSP(Phosphor plates).

Place film or sensor on the teeth and hold it with a finger not to be moved.

In case of use of film or PSP, make sure it's not bent or twisted to avoid the

distortion of the image.

The detector should be placed at the center of focal spot parallel as Figure 6.9.

CHECK Before operator exposes X-ray, position of film or intraoral sensor or PSP

and COCOON should be parallel. If the angle is deviated, the image can be

Figure 6.5 POWER BUTTON

36

Target tooth

Detector

COCOON cone

6.4.3 COCOON positioning

The distance between the end of the cone and the patient must be within 20cm (8

inches) at least from Focal Spot (X-ray focus point).

The target tooth should be located at the center of the cone in order to get a

whole shape of target tooth.

Operate exposure so that the intraoral detector and COOCON'S cone are parallel

and teeth at the center of cone

Figure 6.6 Film or Intraoral sensor positioning

37

6.5 Control of COCOON

6.5.1 Main control screen composition

○1E

A Main(X-ray) control screen

Figure 6.7 Name for each part on Main(X-ray) control screen

Detector type : Indicates the type of used detector.

Selecting adult or child: Patient type can be selected as adult or child.

Status: Indicates the current operating state of the device.

Status of Battery: Indicates the current state of the battery.

Tooth type: Indicates the type of tooth.

Exposure time: Indicates X-ray exposure time.

Indicate selected parameter: Indicates selected parameter among the Detector type,

Patient Type, Tooth Type and Exposure Time parameters.

6.5.2 Main control screen

At main control screen, Detector type, Patient type, Tooth type, the Exposure time

can be adjusted.

Each parameter is adjustable using the touch panel on the main body as shown in

Figure 6.8.

Detector type Exposure Time

Status Status of Battery Selecting Adult or Child

Indicates Selected Parameter

Tooth Type

38

To select the 'Adult' or 'Child' mode, touch the ◀ ▶ touch panel to activate the

parameter and touch the ▲ ▼ touch panel to change the type.

Touch the ◀ ▶ touch panel to activate the exposure time parameter and touch

the ▲ ▼ touch panel to change the exposure time. When the exposure time is

changed, the type of tooth is changed that corresponds to the changed exposure

time.

Touch the ◀ ▶ touch panel to activate the tooth type parameter and touch ▲ ▼

touch panel to change the tooth type. When the tooth type is changed, the

exposure time is changed that corresponds to the changed tooth type.

Figure 6.9 Screen when selecting 'Child' and 'Adult' mode

Figure 6.8 Control screen on the main body

39

6.5.3 Setting the Exposure Time

When power is turned off, the most recent setting for exposure time is stored in memory and

redisplays when power is turned on again.

To change exposure time setting touch the ▲ ▼(increase/ decrease) touch panel.

6.5.4 X-RAY exposure

The position of exposure trigger and safety lock is as shown in Figure 6.10.

When X-ray exposes, the user must keep pressed the exposure trigger.

COCOON's X-ray exposure procedure is described below. Please set up the location

of user and patient at the best for shooting before exposure X-ray.

①Set up the exposure time according to a recommendation for target tooth or

user's experience and preference.

②Place film or digital intraoral sensor or PSP tightly inside the target tooth.

③Place main body to the target tooth and at parallel with film or intraoral

sensor or PSP. Then press X-ray trigger.

Exposure trigger

Safety lock

CAUTION X-ray is generated while x-ray exposure trigger is pressed only. If the

exposure trigger is released while exposure buzzer sounds, exposure stops

immediately.

Figure 6.10 Exposure trigger and Safety catch of COCOON

40

④Keep pressing the trigger until the exposure is finished and place the main

body in a safe place.

⑤Check images from film or sensor or PSP after shooting.

When pressing the trigger, a melody plays to signal the x-ray exposure warning

sound, which is followed by a consecutive buzzer sound. X-ray is only generated

during the period of consecutive buzzer sound.

When X-ray is generated, the 'READY' signal on upper main control screen changes

to 'EXPOSURE'. The X-ray indicating lamp of the main body is changed from green

to yellow.

When the X-ray exposure is finished, the 'EXPOSURE' signal disappear from the

upper main control screen and 'WAITING' signal is displayed. Thereafter the 'READY'

signal returns. When the 'READY' signal returns, the yellow exposure lamp will

return to green.

Exposing of X-ray is only during buzzer sound while the trigger is being pressed,

and exposure will stop when the trigger is released.(DMS method - Dead Man

Switch)

Figure 6.11 Before, during, and After Exposure screen

CAUTION Parameter set by teeth types can vary by sensor type and film, distance to

patient, image preference. Please refer to it as recommendation only.

41

6.5.5 X-RAY parameter set

COCOON's X-ray exposure strength is 70 [kV], 2[mA] or 1.7[mA], 0.05 - 1.5 [s] and

changeable by exposure time.

Exposure time can be adjusted between 0.05 - 0.1 [s]

Please refer to Table 6-1 below to adjust parameter for each tooth type.

Table 6-1. Time set table by tooth

Classification Teeth types and exposure time

Age

Adult - -

Child

- -

Distance between

cone and skin

(18cm)

SENSOR 0.05 ~

0.10

0.10 ~

0.15

0.15 ~

0.20

0.20 ~

0.25

0.25 ~

0.30

0.30 ~

0.35

0.35 ~

0.40

0.40

~

FILM 0.15 ~

0.25

0.25 ~

0.35

0.45 ~

0.55

0.60 ~

0.70

0.70 ~

0.80

0.80 ~

0.90

0.90 ~

1.00

1.00

~

1.10

Distance between

cone and skin

(20cm)

SENSOR 0.10 ~

0.15

0.20 ~

0.25

0.25 ~

0.30

0.35 ~

0.40

0.40 ~

0.45

0.50 ~

0.55

0.65 ~

0.70

0.75

~

FILM 0.25 ~

0.35

0.35 ~

0.45

0.55 ~

0.65

0.70 ~

0.80

0.80 ~

0.90

0.90 ~

1.00

1.00 ~

1.10

1.10

~

CHECK Exposure time set will be saved automatically when the device turns off

and the last setting will stay until a new setting is attempted after the

device turns back on.

42

6.5.6 Screen setting

Touch ▲ ▼ panels together to move to the screen setting. The current menu is

displayed as the location of the cursor. The name of each part of the screen is shown

in Figure 6.12.

Use the 'Select' panel to select the menu with the cursor in front.

Touch ◀ ▶ panels to change the parameter.

Power save time: Indicates that device turns off automatically if not used for a few

minutes.

Software version: Indicates the currently applied software version.

Explanation of products: A brief description of the product is played for about 3

minutes

Sound effect: Guide the function and status to voice.

Audio guidance

Voice Description

Power save time

F/W version

Figure 6.12 Setting screen

43

7 Quick user guide

① Press power button over 1 second. Then the OLED display should illuminate, accompanied

by a single audible signal.

② When Main control screen display, the operator can select parameter, which operator

want changing setting value, by ◀/▶ direction touch panel.

44

③ Operator select parameter which operator want to change setting value, then change

the setting value by ▲/▼ direction touch panel.

④ Check the safety lock position before exposing the x-ray. Then press exposure trigger.

45

⑤ Position of film or intraoral sensor or PSP and COCOON's cone should be parallel. And

the target tooth should be located at the center of the cone in order to get a whole

shape of target tooth.

⑥ Check the X-ray image. If the image is an abnormality, try the above procedure again.

If there is no abnormality, press power button over 1 second in order to turn off the

device.

⑦ After use COCOON, please keep in a safe place.

46

8 Inspection items before repair request

8.1 Check items before requesting inspection

If abnormality is found in product, confirm following items before inspection request

Table 8-1. Steps to take for device malfunctions

SYMPTOM STEPS TO TAKE

Pow

er d

efec

t

After turning on

power, both sound or

OLED screen is not

turned on

Check that the battery is charged.

OLED screen is not

displaying after 'power

on' sound is heard

Check 'Screen brightness' in screen setting. The

darkest level is 1 and brightness level is 10.

Device turns off

automatically while in

use

Check that the battery is charged.

Exposu

re d

efec

t

Exposure sound is not

heard when X-RAY is

exposure

Check if OLED display is main control screen status. X-

ray is exposed with main control screen only.

SYMPTOM STEPS TO TAKE

47

Oth

ers

DC adaptor is not

working

Check that the DC adaptor is connected to the AC

power cord.

Check that the AC power cord is connected correctly

to AC power outlet. Correct input voltage of this

device is AC 100-240V, 50/60[Hz]

When DC adaptor is connected correctly to the power

outlet, LED light at an upper main part of the device

lights up green.

If the device does not operate despite successful

connection, disconnect it from the power outlet and

contact an authorized service center.

8.2 Troubleshooting

Table 8-2. Troubleshooting

PROBLEM CAUSE SOLUTION

Nothing lights up The battery is low. Connect the battery charger

No X-ray emission

The generator is preparing an exposure. No display on the screen.

Wait for ready to X-ray exposure (about 30 seconds)

Button or trigger defective. Call a qualified service technician.

X-ray emission works, but exposure is too light or completely white

Receptor defective. Call a qualified service technician.

Exposure is positioned incorrectly.

Adjust the position of the exposure 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

Receptor defective. Change the receptor or compare with another receptor.

48

exposure is too dark Exposure time is too long. Decrease the exposure time.

Device defective Call a qualified service technician.

8.3 Maintenance schedule

Periodically review Section '1.1 Intended use / Prohibition for Use' for use and

product labeling to verify instructions for COCOON.

The user should regularly familiarize themselves with Section 3 Warning / Caution

and, Section 4 Items to Check instructions.

When a malfunction occurs, please refer to section 7 to inspect the item. Please

contact the manufacturer/dealer immediately if the product seems to have

abnormalities.

8.3.1 On-going check

When turning on product power, confirm if 'power on' sound plays, and the normal

initial screen is displayed.

Exposure time setting is changed by using direction touch panel, confirm if time is

changed normally.

When X-ray exposure, confirm if buzzer sound plays and exposure indicating

lamp turns to yellow

After device power on, check that the LED light is on and that the device is

operating properly.

8.3.2 Annual User Check

The user should review the following material yearly, and be sure to record their

results in the Maintenance Log Sheets located in Section 7.3.4.

Power button verification: If you press the power button for 1 second, a beep

will sound to signal that the machine has powered on. While the machine is on,

49

press the power button for 1 second to shut the machine down. Please check

that the machine has indeed turned off.

Confirm that the status on the Main Control screen is 'Ready' and that it blinks

when the 'select' panel is touched.

Dead-man button verification: Set the exposure time to maximum seconds.

Then use the exposure trigger to start the X-ray exposure. Before the exposure

time reaches maximum seconds, release the trigger. Check that the X-ray

exposure is terminated.

Setting verification: Under the setting screen, check that the appropriate

settings have been saved.

DC adaptor verification: Connect the DC adaptor to AC source, and make sure

that the LED light signaling turns on.

50

8.3.3 Annual Calibration

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,

Exposure Time, and Dose.

Measurement Method: Final performance measurements are made using a

Piranha554. Exposure time is measured from the moment X-rays are detected until

they are no longer detected, which means 90% crossing setting is selected with no

timmer delays. Linearity is calculated per IEC60601-2-7, 50.102.2a

Enable the COCOON and, with the collimator perpendicular to the test detector,

check exposures into by using the test detector. Compare results with the factory

release parameters indicated in the chart below.

For results outside these parameters, discontinue use and contact DEXCOWIN.

The user should be calibration every year.

Table 8-3 Test Acceptance Ranges

Test

Description

Acceptance

limits

Exposure Time (mSec)

50ms 100ms 300ms 500mS 1000ms

kVp

Accuracy 70kV ±10%

64 ~

77kV

64 ~

77kV

64 ~

77kV

64 ~

77kV

64 ~

77kV

Timer

Accuracy

Set point

±10%

45 ~

55ms

90 ~

110ms

270 ~

330ms

450 ~

550ms

900 ~

1100ms

51

8.3.4 Maintenance Log Sheet

Table 8-4. Maintenance Log Sheet

Maintenance Test

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6

Date /Initial

Date /Initial

Date /Initial

Date /Initial

Date /Initial

Date /Initial

1. Power button

2. Exposure sequence

3. Remote button

4. Deadman button

5. Setting

6. DC adaptor

7. Calibration

52

9 Technical Description

9.1 Basic Technical specifications

COCOON Main Body

Product Type Portable Handheld X-RAY System

Protection type B type

Grade for electrical shock

Waterproof rating IPX0

Mode of operation Discontinuous operation

Cooling method Oil cooling method

X-ray field 58 [mm] Round

Total filtration More than 2.3mmAl

Input voltage 14.8 VDC

Model Name DX-7017 DX-7020

kV (fixed) 70kV 70kV

mA (fixed) 1.7mA 2.0mA

Power consumption 350 VA 350 VA

Exposure time 0.05~1.0sec 0.05~1.0sec

High voltage Generator

Model name DXG-7015 DXG-7018

Input voltage 14.8VDC

Max Output power 105 W 126 W

Rating 70kV, 1.5mA 70kV, 1.8mA

X-ray tube D-401

Focal spot 0.4 mm

Target Angle 12.5˚

Inherent Filtration At least 1.0mmAl

Operating tube voltage 70kV

53

9.2 High voltage generator

9.2.1 X-ray Tube Specifications and Characteristics

X-ray tube model name D-041

Manufacturer TOSHIBA(JAPAN)

Operating Tube 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 mmAl

X-ray Coverage φ70 mm at SID 200 mm

Anode Heat Content 4300 J

Maximum Radiographic Exposure Time 3.2 s

Figure 9.1 Toshiba D-041 X-ray tube outline drawing

54

Figure 9.2 Maximum rating charts

Figure 9.3 Emission & Filament characteristics

55

9.3 EMC Data

COCOON has been tested 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.

Mobile RF communications equipment can effect medical devices.

This equipment generates, uses and can radiate radio frequency energy and, if not

installed and used in accordance with the instructions, may cause harmful interference

to other devices in the vicinity. However, there is no guarantee that interference will

not occur in a particular installation. If this equipment does cause harmful interference

to other devices, which can be determined by turning the equipment off and on, the

user is encouraged to try to correct the interference by one or more of the following

measures.

Reorient or relocate the receiving device.

Increase the separation between the equipment.

Consult the manufacturer or field service technician for help.

WARNING Other cables and accessories may negatively affect EMC performance.

Use of other accessories may result in non-compliance.

COCOON should not be used adjacent to or stacked with other equipment.

If adjacent or stacked use is necessary, COCOON should be observed to

verify normal operation.

56

Table 9-1. Electromagnetic emission

9.3.1 Electromagnetic interference

Radiated emission (electric field): 30 ~ 1000[MHz].

Min. limit margin: 4.9dB at 1000[MHz].

Table 9-2. Radiated emission data

TEST FREQUENCY

[MHz]

ATENNA POL. [H/V]

READING LEVEL [dBuV]

CORRECTION (AF+CL) [dB/m]

EMISSION LEVEL

LIMIT(10m) [dBuV/m]

MARGIN [dBu/V]

Value 1000 H/V- <2.0 30.1 <32.1 37 >4.9

The COCOON is intended for use in electromagnetic environment specified below. The

customer or the user of the COCOON should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment - guidance

RF emissions – CISPR11 Group 1

The COCOON uses RF energy only for its

internal function. Therefore, its RF emissions

are very low and are not likely to cause any

interference with nearby electronic equipment.

RF emissions- CISPR11 Class B The COCOON is suitable for use in all

establishments, including domestic establish-

ments and those directly connected to the

public low voltage power supply network that

supplies buildings used for domestic

purposes.

Harmonic emissions IEC

61000-3-2 Class A

Voltage

fluctuations/flicker

emissions IEC6100-3-3

Complies

57

Table 9-3. Electromagnetic Susceptibility

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

58

9.4 Nominal radiation output

Table 9-4. Dose measured at extremity of 20 cm (8 inch) cone (0 ~ 0.48 sec)

t[sec] D[mGy] t[sec] D[mGy] t[sec] D[mGy] t[sec] D[mGy] t[sec] D[mGy]

0.00 0.00 0.05 0.17 0.06 0.21 0.07 0.24 0.08 0.28

0.09 0.31 0.10 0.35 0.11 0.38 0.12 0.42 0.13 0.46

0.14 0.49 0.15 0.53 0.16 0.57 0.17 0.60 0.18 0.64

0.19 0.67 0.20 0.72 0.21 0.76 0.22 0.79 0.23 0.83

0.24 0.86 0.25 0.90 0.26 0.94 0.27 0.98 0.28 1.01

0.29 1.05 0.30 1.08 0.31 1.12 0.32 1.16 0.33 1.19

0.34 1.23 0.35 1.27 0.36 1.30 0.37 1.34 0.38 1.37

0.39 1.41 0.40 1.45 0.41 1.48 0.42 1.52 0.43 1.55

0.44 1.59 0.45 1.63 0.46 1.66 0.47 1.70 0.48 1.73

Unit: [mGy] ± 20%

Table 9-5. Dose measured at extremity of 20 cm (8 inch) cone (0.49 ~ 1.50 sec)

t[sec] D[mGy] t[sec] D[mGy] t[sec] D[mGy] t[sec] D[mGy] t[sec] D[mGy]

0.49 1.77 0.50 1.81 0.51 1.85 0.52 1.88 0.53 1.92

0.54 1.95 0.55 1.99 0.56 2.03 0.57 2.06 0.58 2.10

0.59 2.13 0.60 2.17 0.61 2.20 0.62 2.24 0.63 2.28

0.64 2.31 0.65 2.35 0.66 2.38 0.67 2.42 0.68 2.45

0.69 2.48 0.70 2.52 0.71 2.55 0.72 2.59 0.73 2.62

0.74 2.66 0.75 2.69 0.76 2.73 0.77 2.76 0.78 2.80

0.79 2.84 0.80 2.87 0.81 2.91 0.82 2.94 0.83 2.97

0.84 3.01 0.85 3.04 0.86 3.07 0.87 3.11 0.88 3.14

0.89 3.18 0.90 3.22 0.91 3.25 0.92 3.28 0.93 3.31

0.94 3.35 0.95 3.38 0.96 3.41 0.97 3.45 0.98 3.49

0.99 3.52 1.00 3.55 1.01 3.60 1.02 3.64 1.03 3.68

59

1.04 3.72 1.05 3.75 1.06 3.79 1.07 3.82 1.08 3.87

1.09 3.90 1.10 3.93 1.11 3.97 1.12 4.00 1.13 4.03

1.14 4.07 1.15 4.10 1.16 4.14 1.17 4.17 1.18 4.20

1.19 4.23 1.20 4.26 1.21 4.29 1.22 4.33 1.23 4.37

1.24 4.40 1.25 4.44 1.26 4.48 1.27 4.51 1.28 4.54

1.29 4.58 1.30 4.61 1.31 4.64 1.32 4.67 1.33 4.70

1.34 4.73 1.35 4.76 1.36 4.80 1.37 4.83 1.38 4.87

1.39 4.90 1.40 4.93 1.41 4.96 1.42 5.00 1.43 5.03

1.44 5.07 1.45 5.10 1.46 5.13 1.47 5.16 1.48 5.19

1.49 5.22 1.50 5.25

Unit: [mGy] ± 20%

Test Condition(Voltage): DC 15 [V]

Test Condition(Room temperature): 25 [℃]

9.5 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 r2= 3.14 x (29 [mm])2 = 26.4 [㎠]

60

Table 9-6. Dose area product (0 ~ 0.83 sec)

t[sec] DAP t[sec] DAP t[sec] DAP t[sec] DAP t[sec] DAP

0.00 0.00 0.05 4.43 0.06 5.41 0.07 6.36 0.08 7.31

0.09 8.26 0.10 9.21 0.11 10.13 0.12 11.09 0.13 12.05

0.14 13.02 0.15 13.96 0.16 14.92 0.17 15.88 0.18 16.81

0.19 17.81 0.20 19.00 0.21 20.01 0.22 20.92 0.23 21.85

0.24 22.80 0.25 23.81 0.26 24.78 0.27 25.75 0.28 26.69

0.29 27.66 0.30 28.62 0.31 29.59 0.32 30.53 0.33 31.50

0.34 32.49 0.35 33.44 0.36 34.39 0.37 35.35 0.38 36.28

0.39 37.24 0.40 38.22 0.41 39.17 0.42 40.10 0.43 41.03

0.44 42.03 0.45 42.97 0.46 43.87 0.47 44.90 0.48 45.80

0.49 46.76 0.50 47.69 0.51 48.77 0.52 49.72 0.53 50.68

0.54 51.62 0.55 52.56 0.56 53.52 0.57 54.43 0.58 55.36

0.59 56.32 0.60 57.25 0.61 58.18 0.62 59.11 0.63 60.08

0.64 60.98 0.65 61.93 0.66 62.86 0.67 63.79 0.68 64.68

0.69 65.61 0.70 66.49 0.71 67.29 0.72 68.33 0.73 69.25

0.74 70.15 0.75 71.12 0.76 72.13 0.77 72.99 0.78 73.91

0.79 74.95 0.80 75.80 0.81 76.75 0.82 77.66 0.83 78.52

Unit: [mGy] x㎠

Table 9-7. Dose area product (0.84 ~ 1.50 sec)

t[sec] DAP t[sec] DAP t[sec] DAP t[sec] DAP t[sec] DAP

0.84 79.37 0.85 80.26 0.86 81.14 0.87 82.11 0.88 82.99

0.89 84.01 0.90 84,93 0.91 85.78 0.92 86.66 0.93 87.50

0.94 88.39 0.95 89.32 0.96 90.17 0.97 91.05 0.98 92.05

0.99 92.91 1.00 93.84 1.01 94.93 1.02 96.04 1.03 97.16

61

1.04 98.21 1.05 99.06 1.06 100.03 1.07 100.98 1.08 102.12

1.09 103.05 1.10 103.86 1.11 104.75 1.12 105.59 1.13 106.49

1.14 107.39 1.15 108.15 1.16 109.23 1.17 110.02 1.18 110.90

1.19 111.78 1.20 112.55 1.21 113.31 1.22 114.23 1.23 115.42

1.24 116.30 1.25 117.15 1.26 118.28 1.27 119.10 1.28 119.91

1.29 120.83 1.30 121.73 1.31 122.48 1.32 123.40 1.33 124.11

1.34 124.89 1.35 125.74 1.36 126.72 1.37 127.51 1.38 128.57

1.39 129.36 1.40 130.15 1.41 130.94 1.42 132.00 1.43 132.79

1.44 133.85 1.45 134.64 1.46 135.43 1.47 136.22 1.48 137.02

1.49 137.81 1.50 138.60

Unit: [mGy] x㎠

62

9.6 Stray Radiation

9.6.1 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 9.4.

60[cm]

60[cm]

200[cm]

63

Figure 9.4 Significant zone of occupancy

9.6.2 Test method and result of stray radiation

The device and environment setup for measurement of stray radiation is Figure 9.5.

After all setups, measure the stray radiation in the significant zone of occupancy.

Considering use environment of the device, set up the distance between Focal spot

and water equivalent phantom as 20cm and 25cm and measure.

The measuring points in the significant zone of occupancy are every 10cm point

from 0cm to 200cm and the measuring point at each height is as red circles in

Figure 9.5.

Exposure time for each measurement is 1sec.

200[cm]

60[cm]

100[cm]

20 or 25[cm] 15[cm]

25[cm]

60[cm]

Focal spot Water equivalent

phantom

Measurement points

Significant zones of occupancy


60[cm]

64

Figure 9.5 Test method of stray radiation

The measurement results of stray radiation at 20cm from Focal spot are as Table 9-8.

Table 9-8. 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 1.784 1.272 0.986

60 cm 2.564 2.536 2.36 1.712 1.452 2.048

80 cm 3.972 3.956 3.008 1.604 1.538 1.455

100 cm 5.256 5.032 3.059 1.408 1.075 1.608

120 cm 5.012 2.964 2.808 1.461 1.166 1.266

140 cm 2.364 3.712 3.104 1.512 1.528 1.107

160 cm 1.146 1.872 1.316 2.612 1.444 1.568

180 cm 3.044 1.084 2.124 1.134 1.604 1.111

200 cm 2.636 1.035 0.814 1.191 1.504 1.027

Unit: [mR/h]

ND: Not Detected

0

1

2

3

4

5

6

7

8

9

10

0cm 20cm 40cm 60cm 80cm 100cm 120cm 140cm 160cm 180cm 200cm

A

B

C

D

E

F

65

0

1

2

3

4

5

6

7

8

9

10


A

B

C

D

E

F

Figure 9.6 Graph of stray radiation at 20[cm] from focal spot

The measurement results of stray radiation at 25cm from Focal spot are as Table 9-9.

Table 9-9. Stray radiation at 25[cm] from focal spot


0 cm 0.968 0.714 0.684 0.863 1.212 1.428

20 cm 1.668 2.076 3.108 1.284 1.452 1.332

40 cm 2.868 2.868 3.300 3.000 2.652 2.436

60 cm 3.972 5.808 3.924 3.708 4.332 3.588

80 cm 5.400 6.612 3.876 1.716 0.511 1.404

100 cm 6.708 4.056 0.087 1.572 0.086 0.648

120 cm 7.824 6.348 4.728 2.196 0.853 1.392

140 cm 4.596 5.580 0.766 3.276 1.668 1.500

160 cm 6.192 4.080 4.020 1.872 1.908 2.376

180 cm 4.860 3.972 3.948 2.268 3.168 3.108

200 cm 4.740 2.724 4.524 1.728 2.508 1.584

Unit: [mR/h]

ND: Not Detected

66

Figure 9.7 Graph of stray radiation at 25[cm] from focal spot

9.6.3 Stay radiation with backscattered shield application

Attach back scattered shield as Figure 9.8 and measure stray radiation.

Considering use environment of the device, set up the distance between Focal spot

and water equivalent phantom as 20cm and 25cm and measure.

The measuring points in the significant zone of occupancy are every 10cm point

from 0cm to 200cm and the measuring point at each height is as red circles in

Figure 9.8.

Exposure time for each measurement is 1sec.

200[cm]

100[cm]

20 or 25[cm] 15[cm]

25[cm]

60[cm] Focal spot

Water equivalent phantom

Measurement points





67

Figure 9.8 Test method of stray radiation with backscattered shield

The measurement results of stray radiation at 20cm from Focal spot are for Table 9-10.

Table 9-10. Stray radiation at 20[cm] from focal spot with backscattered shield


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

40 cm 0.754 0.754 1.037 0.378 0.434 0.321

60 cm 1.636 1.192 1.183 0.478 0.393 0.452

80 cm 3.956 4.032 1.059 0.692 0.403 0.608

100 cm 3.508 3.476 0.732 0.471 0.627 0.351

120 cm 1.432 2.152 0.692 0.373 0.423 0.076

140 cm 1.684 1.031 0.651 0.031 0.381 0.096

160 cm 0.455 0.429 0.785 0.065 0.386 0.388

180 cm 1.568 0.91 1.628 0.332 0.342 0.392

200 cm 1.721 0.878 0.706 0.351 0.442 0.596

Unit: [mR/h]

ND: Not Detected

0

1

2

3

4

5

6

7

8

9

10


A

B

C

D

E

F

60[cm] 60[cm]

68

0

1

2

3

4

5

6

7

8

9

10


A

B

C

D

E

F

Figure 9.9 Graph of stray radiation at 20[cm] from focal spot with backscattered shield

The measurement results of stray radiation at 25cm from Focal spot are for Table 9-11.

Table 9-11. Stray radiation at 25[cm] from focal spot with backscattered shield


0 cm 0.323 0.932 1.266 1.553 1.616 1.280

20 cm 1.319 1.265 2.203 1.637 1.925 1.481

40 cm 2.254 2.350 2.923 1.566 1.406 1.272

60 cm 3.086 4.946 2.734 0.958 0.759 0.963

80 cm 5.132 5.342 1.075 0.493 0.381 0.463

100 cm 4.656 4.178 0.098 0.974 0.974 0.302

120 cm 6.150 5.566 0.563 0.837 0.251 0.438

140 cm 4.121 4.452 1.824 1.037 0.311 0.439

160 cm 5.643 3.036 1.500 0.709 0.592 0.648

180 cm 3.622 3.816 1.572 1.968 1.356 2.148

200 cm 2.276 2.534 2.772 1.142 1.368 1.027

Unit: [mR/h]

ND: Not Detected

69

Figure 9.10 Graph of stray radiation at 25[cm] from focal spot with backscattered shield

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or email to our company.

Dexcowin Co., LTD

#905, 2, Gasan digital 1-ro, Geumcheon-gu Seoul, Korea

Product Warranty

Medical device name

Portable Handheld X-RAY System Type name COCOON

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date

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Contact information

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Place of purchase

Warranty Period

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This product is manufactured under strict quality assurance standard and inspection

process.

If a breakdown occurs during warranty period under normal usage, free repair service

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If breakdowns are due to incorrect usage or negligence, there will be charges for repair

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If you have other questions or product related inquiries, please contact Dexcowin

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