Papaya Manual ENG[1]

Genoray makes the invisible visible ! www.genoray.com

The specification above can be changed to improve performance.

Dental X-ray Imaging System GDP-1CManual

This Product is Medical Equipment.

Jaime Rousseau

Texto escrito a máquina

]

Copyright© 2012

2013 / 5 / 31

Document Ver. 0.1

GDP-1 & GDP-1C

Table of Contents

2 PAPAYA PLUS User manual

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Introducion `k Manual ...................................................................................................................................................................................... 4

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@cudqsdmbh`r `msdr cdk trn .............................................................................................................................................................................. 7

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Rdftqhc`c cd Q`ch`bh¶m.................................................................................................................................................................................... 10

1. GDP-1C Introducion ................................................................................................................................................................................. 11

1.1 Intended Use .................................................................................................................................................................................. 11

1.2 Caracteristicas ................................................................................................................................................................................ 11

1.3 System Basic Specification ...................................................................................................................................................... 12

1.4 Equipment Composition ........................................................................................................................................................... 13

1.5 Accessories ...................................................................................................................................................................................... 14

1.6 Patient Apply Part ........................................................................................................................................................................ 15

1.7 On / Off Switch ............................................................................................................................................................................. 16

1.8 Hand Switch .................................................................................................................................................................................... 17

1.9 Emergency Stop Switch ............................................................................................................................................................. 18

1.10 Equipment’s Control Button ................................................................................................................................................... 19

1.11 Laser Control Knob...................................................................................................................................................................... 20

1.12 Changing Detector ...................................................................................................................................................................... 21

1.13 Device status LED ......................................................................................................................................................................... 22

2. OP (Operation panel) .............................................................................................................................................................................. 23

2.1 OP Structure.................................................................................................................................................................................... 23

2.2 X-ray Exposure Mode ................................................................................................................................................................ 25

2.2.1 Panorama program ......................................................................................................................................................... 25

2.2.2 Cephalo Program ............................................................................................................................................................. 29

2.3 Choose Patient Size ..................................................................................................................................................................... 31

2.4 Exposure Speed and Change of Image Quality ............................................................................................................ 31

2.5 Selection of Jaw shape .............................................................................................................................................................. 31

2.6 X-ray exposure condition change........................................................................................................................................ 32

2.7 Order list ........................................................................................................................................................................................... 32

2.8 Device condition display screen ........................................................................................................................................... 34

2.9 Option setting ................................................................................................................................................................................ 35

2.9.1 General .................................................................................................................................................................................. 36

2.9.2 DB Server ............................................................................................................................................................................. 37

2.9.3 DB Server ............................................................................................................................................................................. 38

2.9.4 Version .................................................................................................................................................................................. 39

Table of contents

PAPAYA PLUS User manual 3

3. Image acquisition ...................................................................................................................................................................................... 40

3.1 Registration of patients and orders. .................................................................................................................................. 40

3.1.1 Registration with Triana software. ...................................................................................................................................... 40

3.1.2 Registration with OP software. ............................................................................................................................................. 41

3.2 Panorama mode Set position of patient .......................................................................................................................... 42

3.3 TMJ mode patient position set ............................................................................................................................................. 46

3.4 Sinus mode patient position set .......................................................................................................................................... 51

3.5 Cephalo mode patient position set .................................................................................................................................... 56

3.6 Image taking ................................................................................................................................................................................... 58

3.7 Image Control ................................................................................................................................................................................ 60

3.8 TWAIN INTERFACE ....................................................................................................................................................................... 61

3.9 OP Additional Function .............................................................................................................................................................. 61

3.9.1 Sending to DICOM Server........................................................................................................................................... 62

3.9.2 Burning CD ......................................................................................................................................................................... 62

3.9.3 Register addition order ................................................................................................................................................. 63

3.9.4 Opening of patient's folder ......................................................................................................................................... 63

4. Cleaning .......................................................................................................................................................................................................... 65

5. Handling of waste ..................................................................................................................................................................................... 65

6. Message .......................................................................................................................................................................................................... 66

6.1 Error message ................................................................................................................................................................................ 66

6.2 Condition message ...................................................................................................................................................................... 68

7. Technical Data ............................................................................................................................................................................................. 69

7.1 Classification ................................................................................................................................................................................... 69

7.2 Power Requirements ................................................................................................................................................................... 69

7.3 Complied Standards .................................................................................................................................................................... 69

7.4 X-ray source assembly ............................................................................................................................................................... 70

7.5 Beam Limiting Device ................................................................................................................................................................ 70

7.6 Detector ............................................................................................................................................................................................ 71

7.7 Dimensions and Weights ......................................................................................................................................................... 72

7.8 Movement ........................................................................................................................................................................................ 73

7.9 Other Information ........................................................................................................................................................................ 73

7.10 X-ray Tube ........................................................................................................................................................................................ 74

7.10.1 OPX – 105 (CEI) ................................................................................................................................................................... 74

7.10.2 D-054SB (Toshiba) ............................................................................................................................................................. 76

8. Labeling .......................................................................................................................................................................................................... 78

8.1 GDP-1 ................................................................................................................................................................................................. 78

8.2 GDP-1C .............................................................................................................................................................................................. 79

Appendix 1. ........................................................................................................................................................................................................... 82

Introduction of Manual


Introduction of Manual

GENORAY’s GDP-1C is digital panoramic X-ray system. This manual is designed for your safe use and

operation of GDP-1C. When using GDP-1C, use .

The potential risk always exists when using X-ray products and electric medical equipments. All users should

be aware of the methods of use, solutions in emergency conditions and other safety articles provided in this

manual.

The user must acknowledge the appropriate ways to protect oneself from the potential danger that could

occur at any time, and be aware of the condition of the product that can cause danger.

The manufacturer, assembler, and the importer hold responsibility upon the performance of safety, trust

and the article below.

- Guarantees the installation of the eligible professional, calibration, and repair.

GENORAY Co., Ltd is continuously developing the products. The manual or composition of the package

might change without notice

Tel : +82-31-737-8020 FAX : +82-31-737-8018

E-mail : [email protected]

Address : #512 Byucksan Technopia 434-6, Sangdaewon 1-Dong, Jungwon-Gu,

Seongnam-City, Gyeonggi-Do, Korea

Certificate of Warranty


Certificate of Warranty

Range and terms for warranty

GENORAY guarantee this product without any expense for the mal-function or disorder occurred under

standard transportation and operation within 1 year from installation. Defect on its appearance is out of the

range of warranty.

Requirements on After service call

When the malfunction or disorder appeared, stop operating and check again the related article of the “User’s

Manual.” Before your calling, please put off this equipment and check for the Model Name, serial No. and

purchasing date. GENORAY Co., Ltd. is not responsible for indirect harm. GENORAY Co., Ltd. cannot warrant

for defect or harm after warranty period.

Electrical Safety


Symbols used in product

Symbol description Symbol description

X-Ray Source Assembly,

X-ray radiation

Manufacturer, Address

Caution

Manufacturing Date

Refer to User’s Manual

Product serial number

Type b applied part

WEEE Mark

AC (Exchange)

Laser

This symbol is information about the special matters that require attention while using this

software.

This symbol is warning the situation or environments which might bring danger to the patients

or users.

Warning before Use


Warning before Use

This machine can be dangerous for all users if the safe exposure condition and appropriate using

method are not attended.

This machine can only operated by authorized user.

This machine need to operate after studying of manual.

Random modification on machine is prohibited.

There is prohibition of installing different composite parts unless they are supplied by manufacturer.

Do not connect equipment’s power source with multi-adaptor or extension cord. This can cause defect or

become cause of mal-function.

Do not operate machine when the machine is defect or malfunctioning. Please contact engineer or

service center for help.

Do not use provided PC for unintended purpose. There is probability some problem could happen on

transferring images and reconstructing if the PC uses for unintended purpose.

Electrical Safety


Electrical Safety

The electric circuit of this product uses the electric current which can cause death due to severe

injury or electric shock. To avoid this kind of danger, do not remove any of the covering part.

To avoid failure and the danger that might cause serious injury or electric shock to users and patients, please

acknowledge the safety procedures listed below.

Before cleaning the product, always turn off the power and separate the power cord, and clean the

product with lightly wet cotton or sponge.

Never let anyone remove the cover except for the professional technician of GENORAY.

Do not place food on any part of the product. They might get into the electric circuit and get into

contact with electrical matters

The product is not waterproof to water, soap or liquid substances. If the liquid contacts the

product, it may cause fire or electric shock. If the liquid was in the product by accident, do not

touch the power cord connecting to the power, and wait until the liquid is completely dry.

The user should follow the safety guideline provided below.

Turn off the power and separate the power cable from the socket.

Stay far away from the place where the product has been installed.

Ask for help around you.

Use the fire extinguisher authorized only for the electric fire.

Abnormal use of fire extinguisher could be dangerous and cause fire or electric shock. To avoid

this kind of danger, check to see if the product can be used where the product has been

installed, and always use the authorized product.

PAPAYA Equipment Introduction


Before use this product, please check below.

Before connecting the power, check to see of the power supplying line is appropriate to this product.

Check the power and connect the power cable of this product to its power socket.

Check the categories mentioned above in case of power input of all accessory (the signal input/output

including accessory).

For reducing the risk of electrical shock, and when connecting to power, there needs protecting

ground connection.

Place this product away from other X-ray products, power generating equipment and

broadcasting stations. If the product is sharing the power with other electric devices, abnormal

image might occur.

The protection level of PAPAYA Plus is the 1st grade equipment or type-B equipment. This

product does not prevent the invasion of liquid substances.



Radiation Safety

This product has to follow designated country’s radiation law.

This product needs X-ray room. Except the patient, no one can enter X-ray room unless they are patient.

While taking exposure, clear space between patient and equipment need to be maintained.

For this product’s safe operation, it needs to be installed at appropriate location with permission of

owner. Also, user needs to guarantee about whether equipment will be used at place where owner has

chosen.

This product’s owner is, while using this equipment, all users need to be guaranteed about wearing X-ray

protection device.

When exposure of X-ray, operator needs to stay away from equipment more than 2 meters.

For this product, users need to wear TLD badge, and check dosage exposure regularly.

When the pregnant woman or young child need to take exposure and need to consult with specialist

before.

If you do not follow written rules in this manual, there can be risk for operator and patient.



1. GDP-1C Equipment Introduction

1.1 Intended Use

Digital Panoramic & Cephalometric X-ray System, GDP-1C is used for taking image of anteroposterior’s

panoramic view, head’s cephalo view. This equipment is only used for doctor, dentist, and radiologist.

1.2 Equipment’s Characteristics

This equipment is used for diagnosing of teeth, chin, and head. This equipment is producing and is

controlling X-ray, and composed of X-ray generator, X-ray control part, and X-ray support part. The basic

concept of acquiring image is to produce high voltage between X-ray tube’s both positive and negative, and

exposure X-ray to subject, and transmitted X-ray to exposure at sensor and acquire the image.

X-ray Generator High Frequency, Fixed Type Tube,

60 ~ 90kV, 4 ~ 12mA

Focal Spot Size 0.5mm

Image Detector CdTe flat panel

FOV Panorama: 4.8mm x 150mm

Ceph: 4.8mm x 240mm

Image Acquisition / Angle

(Standard panoramic) 210°

Scan Time / Exposure Time Panorama: 17sec(max), Cephalo: 17sec(max)

Patient Position Standing

Reconstruction Type Fan beam

Reconstruction Time Less than 30 seconds

Weight 110 kg ± 5kg (Basic), 140 kg ± 5kg (Cephalo)

Main body 1010 x 1055 x 2312 mm (Basic)

1010 x 1775.4 x 2312 mm (Cephalo)



1.3 System Basic Specification

[ System Connection Image ]

PC is used for acquiring and displaying image, and for image processing.

GDP-1C

PC Hand Switch

Ethernet



1.4 Equipment Composition

This machine has panoramic only model of GDP-1 and has added cephalo exposure that is

GDP-1C. Each model’s composition or exterior, please refer to below pictures.

[ GDP-1 ] [ GDP-1C ]

No. description No. description

1 BASE 7 Patient supporting area

2 Fixed column 8 X-ray control equipment

3 Driving Unit 9 Cephalo Arm

4 Rotating Unit 10 On/off switch

5 X-ray source assembly 11 Hand Switch (Exposure button, Emergency

stop switch)

6 Detector (Panorama, Cephalo using for

both, detachable structure)

12 Emergency stop switch

13 Device status LED

3 9

1

2

5

4

7

8

9

10

11

12

6

13



1.5 Accessories

Patient’s condition or according to exposure mode, chin rest can be changeable.

[Standard Exposure] [For No Teeth Patient] [SINUS & TMJ mode]

Chin rest change method

For appropriate exposure mode, insert correct chin rest to designated hole.

Must use spare part that is provided by manufacturer. If you damage machine when using

different spare part, and then the manufacturer does not have responsibility of fault.



1.6 Patient Apply Part

After exposure, sanitize patient apply part.

Cephalo part

Panorama part

Ear rod

Nasal

positional

Temple support

Bite

Chin rest

Patient handle



1.7 On / Off Switch

Equipment’s on/off switch is like on picture, it is located at equipment’s below part. If turning on

equipment’s switch, and the equipment’s LED has light and displays equipment’s waiting condition.

ON OFF



1.8 Hand Switch

Hand switch is made with magnet and can be hung

on wall. At hand switch, as seen on picture right,

there is X-ray exposure switch and emergency stop

switch, they are two functions together. While

emergency switch is used when equipment is

malfunctioning or it can harm patient. At moment,

equipment will stop.

Exposure switch need to be pushed continuously while is to exposure patient’s diagnostic image.

If during exposure, switch is not pushed and machine’s movement is stopped instantly and at

OP, advisor word will be displayed.

X-ray exposure

switch

Emergency stop switch



1.9 Emergency Stop Switch

Emergency stop switch is located at above picture. When emergency situation happens and push button and

equipment’s driving unit or X-ray source assembly’s power supply stops and machine will stop.

When pushing emergency stop switch, turning switch to clockwise to unwind and machine will

operate normally.



1.10 Equipment’s Control Button

Equipment is controlled by equipment’s control button and controls equipment’s movement or controls laser.

Each button’s function is as below.

Controlling equipment’s height. ‘LIFT DOWN’ button moves equipment

downward and ‘LIFT UP’ button moves equipment upward.

Using when user wants to change the detector.

Turn on/off equipment’s laser. When pushing once, laser turns on and pushing

one more time and laser turns off. Laser will turn off after time. It will turn off

automatically.

Using when equipment’s gentry is moved forward and backward. By using

laser, use to decide patient’s exposure location. ‘FORWARD’ button used for

moving gentry to user and ‘BACKWARD’ button used for moving genty,

opposite side to user.



1.11 Laser Control Knob

This equipment, as shown above picture, has laser control know. Before to exposure, when controlling

patient’s position, using laser control knob to adjust to Frankfort line.

Laser Control Knob



1.12 Changing Detector

This equipment is according to exposure mode, detector needs to move.

Detector Detachable Method

A. Pushing detector handle area’s

switch.

B. While pushing switch, pull

detector downward.

C. By disassembling hook part

and pushing detector upward

and detector will fall out.

Following above change method and doing reverse way and detector will be attached.

When to exposure Cephalo

Detector’s Location

When to exposure Panorama

Detector’s Location

OP (Operation Panel)


1.13 Device status LED

LED Color description

Blue Rotating side is at rotation

Yellow while X-ray exposure

Green When X-ray exposure, ready

White Completion of X-ray exposure

Red While taking exposure, error occurs or pushing

emergency switch



2. OP (Operation panel)

2.1 OP Structure

Manual’s used picture can differ from real program’s version.

Patient or uneducated person must not operate OP. Please be aware.

[ Operation Panel Program / Main Screen ]

2

3

4

5 6

7 8

10

11

12

9 1



No. Subject description

1 Exposure Time Display

Screen Displaying current time.

2 Patient’s Information

Display Screen Displaying patient’s information who wait for current exposure.

3 Exposure Mode Choose

Button Choosing equipment’s exposure mode.

4 Exposure Program Choose

Button Choosing equipment’s exposure mode by exposure program.

5 Patient’s Size Choose

Button Choosing according to patient’s size by pre-set value.

6 Image Quality Choose

Button Deciding exposure image’s quality.

7 Exposure Condition Display

and Change Part Controlling equipment’s exposure condition manually.

8 Equipment Movement

Button Part

Deciding exposure condition and preparation completion and

opinion.

9 Equipment display Display equipment’s condition

10 Jaw shape selection button Choosing patient jaw shape and size

11 Order list button Managing patient information and order list

12 Exposure Program Display Displaying selected exposure program

ease before take an exposure, always look equipment’s display and check whether equipment can

take an exposure. About equipment’s condition, please refer to 2.6.



2.2 X-ray Exposure Mode

GDP-1 is supporting various types of X-ray exposure mode. At 2.2.1 of Operation Panel Program, at main

screen, by pushing wanted x-ray exposure mode and push x-ray button and be able to choose program.

2.2.1 Panorama program

Exposure Mode Mode Type Program

Panorama mode

Standard Panoramic

Standard panoramic has standard panorama’s image field of view and

Taking exposure.

Orthogonal Panoramic

Orthogonal Panoramic is comparison to Standard panoramic

program that takes x-ray exposure with x-ray beam’s angle as 90° of

penetration to chin, and produce field of view. At standard

panoramic image, teeth is overlapping and effect is decreasing, but

exposure area’s opposite side’s shadow of teeth and chin and add an

effect.




Bitewing Panoramic

Bitewing Panoramic program works at panoramic image and take

exposure of bitewing area and take exposure of trajectory of patient.

In basic, Bitewing Panoramic is orthogonal panoramic and take

exposure with same angle.

TMJ mode

TMJ lateral

TMJ lateral exposure has function of trajectory and side of

temporomandibular joint. Taking exposure of both sides of

temporomandibular joint and comparing, patient opens mouth and

the patient closes mouth to distinguish temporomandibular joint

exposure.

TMJ PA

TMJ PA takes exposure of temporomandibular joint’s PA direction

and take exposure with trajectory direction. Both sides of

temporomandibular joint can take exposure and using as patient

opening mouth and closing mouth.




Double Lateral-PA

Lateral – PA program takes exposure of temporomandibular joints’

PA and Lateral direction alternately. Both sides of

temporomandibular joint can take exposure and using as patient

opening mouth and closing mouth.

Sinus mode

Sinus Midsagittal

Sinus midsagittal exposure enables to take exposure of maxillary

sinus and use it. The image’s focus is on midsagittal surface.

Sinus lateral

Sinus lateral exposure is like Sinus midsagittal, at maxillary sinus,

take a exposure at maxillary sinus’ trajectory. From midsagittal

surface’s standard, now focus surface can be toward left or right

side.




Sinus PA

Sinus PA takes an exposure at PA’s direction of maxillary sinus.



2.2.2 Cephalo Program


Cephalo mode

Cephalo lateral

Cephalo lateral exposure has at patient’s side, and X-ray beam’s

penetration of direction.

Cephalo AP

Cephalo AP exposure is that at toward AP’s direction, X-ray

penetrate and taking exposure of skull.

Cephalo PA

Cephalo PA exposure is that at toward PA’s direction, X-ray penetrate

and taking exposure of skull.




Water’s view

Water's view is when the patient is at with Frankfort line and wit

h detector surface, and taking exposure with 45 degree angle slo

pe and is exposuring area of head.

SMV(Submento vertex)

SMV takes exposure of according to patient’s Frankfort line and the

surface of detector is leveled with horizon and put patient in this

position to take exposure.

Carpus

Carpus takes exposure of wrist. In order to do Carpus exposure,

using carpus exposure wrist panel and install it and take exposure.



2.3 Choose Patient Size At all exposure program, according to patient’s size and can choose appropriate patient’s size.

Among 4 different size, can choose one size, and according to choice of size of patient, each exposure

program has saved X-ray exposure condition with trajectory. At each exposure program, X-ray exposure

condition is set up differently.

2.4 Exposure Speed and Change of Image Quality

At each exposure program, you can choose different image quality. The image quality can choose between

Normal, Fast, HD(High Definition). They are total of 3 types and can choose one.

Fast image has lower image quality and HD has longer image processing time but image.

2.5 Selection of Jaw shape

You can choose different jaw shape and size of patients. There are 9 options by following 3 jaw shape (Sharp,

Normal, Square) and 3 jaw size (Small, Average, Large).

Normal Fast HD ( High Definition)

Normal Sharp Square

Small

Average

Large



2.6 X-ray exposure condition change

X-ray condition can be changed by clicking the left or right arrow button of kVp & mA condition value on

the x-ray condition display screen like the below image. kVp can be changed 1kVp per 1 click and mA can be

changed 0.5mA per 1 click. The exposure time can’t be changed.

The exposure condition value is chosen automatically when choosing patient size & exposure

program. If you’d like to change the exposure condition by yourself, you can do like above.

2.7 Order list

1

4

5

2 3



Click the order list button, refer to 2.1, then the order list management window will be appeared. Functions of

each part are described in below table.

No. Subject description

1 Order status filter

Displaying patients’ information of registered order by following

selected filtration option.

Ready: Displaying order information be in ready and wait status.

All: Displaying all order information.

Done: Displaying order information exposure is finished.

2 Worklist Loading patients’ information from worklist server.

3 Search Searching order information.

4 Order information window Displaying registered order information. Time, status, ID, name and

exposure program information are displayed.

5 Order management button

Managing order.

Register: Executing order registration window.

Select: Selecting registered order of order list for taking image.

Modify: Modifying registered order information.

Delete: Deleting registered order information.

Close: Closing order list and returning to main screen of OP.

This below picture shows a window appears when you click ‘Register’ button, user can input patient information

and select exposure program with this window.



2.8 Device condition display screen

Device condition display screen shows the current condition of device.

Condition Description

It shows the connection of device & PC. When the device is connected with

PC, it turns orange color.

It shows the temperature of X-ray generating part of device. If the X-ray

generating part is overheated, it turns red color. In this case, please don’t

exposures X-ray until the temperature becomes normal.

Green: normal, Orange: caution, Red: warning.

It shows the connection condition of the device sensor to the panorama or

cephalo position. “P” turns violet when the sensor is connected to panorama

position. And “C” turns green when the sensor is connected to panorama

position.

Image acquisition


2.9 Option setting

PAPAYA OP program needs to set

No. Name Explanation

1 General Display composition or user's convenience need to be set

2 DB Server Material composition or data management need to be set.

3 DICOM Outside compatibility or DICOM function need to be set

4 Version Machine or program version need to be displayed

Image acqusition


2.9.1 General

Name Explanation

Language Setting language

Font Setting Font

DAP Setting DAP output measurement

Data Format Setting data format.

Clinic Name Save by inputting Clinic Name

Volume control Controlling machine's sound

Multi Focus

Setting Multi Focus using or not using

Number Setting multi focus' pages

(3,5 page setting is abled)

Step Setting space between images

All save Saving images that is processed with Multi focus

Auto Process

Automatically setting processing / no processing

Send DICOM After taking exposure, automatically send with DICOM

format

Test Operation Setting for exposure test.

R-Mark Setting exposure images' position mark's printing out / not printing out

Use Cephalo Adding cephalo mode function (*Option)

Save Raw images Setting Raw image's setting (If checking and taking up a lot of hard disk

Image acquisition


2.9.2 DB Server

Name Explanation

SQL Server Information Server Name Setting Order DB's usage path

Triana Server Name Setting DB path at Triana

Data folder Information

Temp Image At PAPAYA OP, setting saved image path

Triana Image At Triana, by managing image, making im

age saving path

Parameter Setting parameter path

Trouble shoot When problem happens, pushing button to solve problem.

Image acqusition


2.9.3 DB Server

Name Explanation

Linkage Setting about interface about compatibility

Equipment Information Inputting machine's information for DICOM usage

Storage Server Setting DICOM Storage server

MWL Server Setting Work list server

DICOM Printer Setting DICOM Printer

System Log When pushing test button and printing out processing result

Image acquisition


2.9.4 Version

Name Explanation

PAPAYA OP Displaying program version at PAPAYA OP

PAPAYA Bridge Displaying program version of PAPAYA Bridge

PAPAYA REC Displaying version of PAPAYA REC program

M/B Displaying Papaya's main board version

sound Displaying PAPAYA sound controller

LIFT Displaying PAPAYA LIFT version

Sensor Serial num Displaying sensor serial number

Image acqusition


3. Image acquisition

3.1 Registration of patients and orders.

3.1.1 Registration with Triana software.

Please refer the Triana manual provided with device for more details.

Please follow the process below after running Triana software to operate OP for the device operation.

Patient registration

Click the patient registration button after

running Triana.

Put patient information in

patient registration window.

Click the patient registration

after done.

A. OP operation

[ Panorama ]

[ Cephalo ]

Choose the device among device selection tap once the patient

registration is done.

Papaya is a panoramic device so you can choose panorama. If the case

of the device including cephalo function, you can choose one between

panorama & cephalo.

Order information will be registered when you click the acquisition

button.

Image acquisition


3.1.2 Registration with OP software.

Execute order registration input window; Refer

to 2.7, Press register button positioned at

bottom-left of order list.

Input patient information and select exposure

program to the window. Order information will

be registered when you click the register button.

Then you can see the registered order

information in the order list.

Image acqusition


3.2 Panorama mode Set position of patient

Panorama takes panorama images of upper/lower jaw.

1. Set detector on the exposure position.

Please refer 1.12 about how to install the detector.

[ For regular teeth ] [For patient without teeth]

2. [ For regular teeth ] Set chin-rest & bite on the

device.

The patient who doesn’t have teeth or hard to bite

the bite should install & use the chin-rest for

patient without teeth.

In case of using a chin-rest [For regular teeth],

cover it with clean cover. Remove clean cover used

and don’t use again.

Refer 1.5 about how to install the chin-rest.

Image acquisition


Please let the patient remove eye glasses, hearing aid, false/artificial teeth, hair pin, other

accessories and metal etc. before taking X-ray images. If not, the shadow or reflected images

can be seen. Please remove the cloths wearing around the neck such as scarf, muffler, necktie

for the safety.

3. Operate OP by clicking panorama exposure button after registering a patient according to 3.1

4. When you click “Confirm” button after setting panorama mode & exposure condition on operating OP,

“Confirm” button turns “Ready” button, and then patient position arrange window comes out.

You can’t change the X-ray condition after clicking ‘Confirm’ button. X-ray condition & exposure

change is possible on start screen by ‘Back’ button.

Image acqusition


5. After being the patient positioned, set height on patient’s height by using 1.9 device set button.

6. Cover bite with clean cover, let the patient put their chin on

chin-rest and bite the bite.

If patient can’t raise their neck, set the height of device by using device set button.

7. When the position of patient is correct, lead patient to

grab a handle.

8. Set the position of patient by pressing laser button ( ) of device set button while the patient bites

the bite correctly.

Laser is consists of 3, you should let the patient be positioned for all 3 lasers correctly to get a

good quality of image

9. When the laser is turned on, set midsagittal laser to midsagittal of

patient by moving patient’s head.

Image acquisition


10. Set Frankfort laser to Frankfort of patient by controlling angle of

patient’s head.

If the position of laser is not correct, set the height of laser by

moving Frankfort laser control knob.

Frankfort plane is the straight line connecting upper part of an

earhole & lower part of eyes.

11. Finally move the position of laser by using ‘FORWARD’ &

‘BACKWARD’ button on patient control button to be canine laser

positioned on dogtooth of patient.

Laser is turned off automatically after few minutes or if the exposure starts.

12. Check whether the position of 3 lasers is correct after

positioning the patient by using Temple support. If it is

not correct, be the patient positioned correctly.

Image acqusition


3.3 TMJ mode patient position set

TMJ mode takes the image of lower teeth on TMJ part.

1. Set detector on panorama position.

Refer 1.12 on how to install detector

[ For TMJ mode ]

2. the chin-rest [for TMJ mode]



can be seen. Please remove the cloths wearing around the neck such as scarf, muffler, neck tie

for the safety.

Image acquisition


3. Operate OP by clicking panorama exposure button after registering patient according to 3.1

4. Set TMJ mode & exposure condition on operating OP and click “Confirm” on right-low side, then

“Confirm” button turns to “Ready” button, patient position control screen comes out.



Image acqusition


5. Set the height by using 1.9 device control button after being the patient positioned.

6. Let the patient lean on the chin-rest like the

image left.

Let the patient be positioned according to open/close the mouth.


7. When the position of patient is correct, lead the

patient grab the handle.

8. Set the position of patient by pressing laser button ( ) of device set button while the patient

stands on correctly.



9. When the laser is turned on, set midsagittal laser to midsagittal

of patient by moving patient’s head.

Image acquisition



patient’s head.





In the case of the exposure program is set to PA mode, move the

Frankfort laser to the TMJ PA laser marked position and adjust patient’s

head angle to position the TMJ is on to the laser line.



positioned on TMJ of patient.

‘FORWARD’ button moves to user’s direction but ‘BACKWARD’

button moves to opposite direction of user’s.


Image acqusition





Image acquisition


3.4 Sinus mode patient position set

TMJ mode takes the image of lower teeth on TMJ part.

1. Set detector on panorama position.


[ for Sinus mode ]

2. Install the chin-rest for [Sinus mode] on device.



can be seen. Please remove the cloths wearing around the neck such as scarf, muffler, neck tie

for the safety.

Image acqusition


3. Operate OP by clicking panorama exposure button after registering patient according to 3.1

4. Set Sinus mode & exposure condition on operating OP and click “Confirm” on right-low side, then

“Confirm” button turns to “Ready” button, patient position control screen comes out.



Image acquisition



6. Let the patient lean on the chin-rest like the

image left.

Let the patient be positioned according to open/close the mouth.


7. When the position of patient is correct, lead the

patient grab the handle.

8. Set the position of patient by pressing laser button ( ) of device set button while the patient stands

on correctly.



Image acqusition


9. When the laser is turned on, set midsagittal laser to midsagittal of

patient by moving patient’s head.


patient’s head.







positioned on Sinus of patient.

‘FORWARD’ button moves to user’s direction but ‘BACKWARD’

button moves to opposite direction of user’s.


Image acquisition





Image acqusition


3.5 Cephalo mode patient position set

1. Set detector on cephalo position.




can be seen. Please remove the cloths wearing around the neck such as scarf, muffler, and

necktie for the safety.

2. Operate OP by clicking cephalo exposure button after registering patient according to 3.1

3. Set mode & exposure condition on operating OP and click “Confirm” on right-low side, then “Confirm”

button turns to “Ready” button, patient position control screen comes out.

Image acquisition





5. Let the patient positioned according to exposure program after being Ear rod positioned to ear hole of

the patient.

6. Set the position of patient by pressing laser button ( ) of device set button while the patient bites

the bite correctly.

7. Laser enters horizontally. Control the angle of laser & patient’s Frankfort according to exposure program.

Frankfort plane is the straight line connecting upper part of an earhole &

lower part of eyes.

Image acqusition


3.6 Image taking

After finishing the fixing the position of patient, press ‘Ready’

button of right-low part of OP after informing the patient not to

move. After the message for taking a X-ray image from OP, the

exposure starts when pressing X-ray shot switch.

Users should exposure from the position safe from X-ray.

Please keep pressing the switch during exposure. If the users take their hands off from shot

switch, the exposure is stopped and then, the error message comes out about the abnormal

shut down.

Focus on patient & condition of device during exposure. If the emergency situation is occurred,

take the hands off right away and then press emergency switch

Image acquisition


When the exposure starts, OP shows X-ray warning message & the image taking, and final image comes out

again after the complete.

Image acqusition


3.7 Image Control

After image exposure finishes and on screen, image is displayed and before push "save" button and

can do image control

Drag mouse's left button Move image within window (Up/down/left/right)

Drag mouse's right button Control Brightness

Drag mouse's both left and right View enlarge or minimize

Double click mouse's left button Re-size image with size of window

Double click mouse's right button initialize image to before control brightness

Move mouse wheel to up or downView if images are many and previous or next i

mage

Image acquisition


3.8 TWAIN INTERFACE

If user's program supports Twain interface, and by using TWAIN data source in which is named,

"PAPAYA" (TWAIN Version 2.1) and can send image to user's program. Sending methods are

supported with Native Mode Transfer and Buffered Memoray Mode Transfer.

The image acquisition by using PAPAYA data source is following.

1. Connect TWAIN session by choosing "PAPAYA" among TWIN data source whithin user's program

2. At user's program, the command of Acquire and send this command, and progress on OP's full

screen mode.

3. From contents of 3.2 to 3.6, depending upon exposure mode and choose exposure mode and

control patient position, and then try exposure of X-ray.

4. After exposure steps are finished normally and click "save" button and send user's program called,

"PAPAYA."

5. After sending is completed, and OP screen is closed automatically and ends with TWAIN session.

TWAIN data source can send image according to usage of Multi Focus that enables to send

more than 1 page. If on user's program and try to receive 1 page of image, and un-check the

check mark on content of 2.9.1's at general option tab and un-check All Save's checkbox.

3.9 OP Additional Function

OP enables burning CD, sending to DICOM server, registering

additional command, opening of patient date folder. Burning CD

and sending of DICOM server function is able for patient who

completed taking exposure. On order list window, clicking

mouse's right button and by choosing patient and pop-up menu

appears for choosing additional function.

Image acqusition


3.9.1 Sending to DICOM Server

At pop-up menu, by choosing send, and this function allows to pre-set to send image to DICOM

server. The DICOM server information is written on 2.9.3 and on DICOM option tab's lower left side

and set on Storage Server. By pushing "Insert Item" button, and input information window appears

and input AETitle, IP, Port, and Timeout and push "Insert" button. At Storage Server's Preset list, and

choose server in which will be sent and finish job by pushing "Save" button.

3.9.2 Burning CD

After taking exposured image and save them by using CD-ROM like media storage device or hard disk.

On pop-up menu, choose "Save to CD" and progress CD burning window.

For media storage device, choosing right side at device list and save image. Checking by Total Space

Used and Free Space and click "Burning" button. After burning is completed and finish and click

"Close" button.

When saving at hard disk or USB, by pushing button and choose save path and process burning.

With image, image viewer of CDSee is also saved.

Media device is connected, but device list doesn't appear and can't choose device, and push "Refresh"

button for updating the device list

On same path inside of CDSee folder, progress CDSee.exe and view saved image.

Image acquisition


3.9.3 Register addition order

Additional order function is that on previous ordered list, and patient need additonal exposure and

doesn't input basic personal information. Then choose exposure program and do registration for order.

If you choose additional order, and have chosen patient's basic information is updated and progress

with registration ordered window. By choosing exposure program, and click "Register" button, and the

order is added on ordered list.

3.9.4 Opening of patient's folder

When choosing opening of folder, search window is opened by starting from where the images are in

saved folder.

Image acqusition


Use condition

Please avoid these conditions for the operation/storing of this device.

Exposure to humidity

Exposure to

Exposure to dust

Exposure to high humidity

Exposure to condition where has problem with ventilation

Exposure to salty air.

Exposure to chemical / harmful gas.

Please avoid use the product the place where has strong vibration or over heat or humidity.

Condition of movement & Storing

Temperature : -20°C ~ 60°C

Relative humidity: 5% ~ 95% RH (But, No dew condensation)

Air pressure : 500 ~ 1100 hPa

Condition of movement when using

Temperature: 15°C ~ 30°C

Relative humidity : 5% ~ 75% RH (But, No dew condensation.)

Message


4. Cleaning

You can clean Bite piece, patient support table, chin rest & patient handle by high pressure sterilization up to

135℃ or cotton/gauze with alcohol.

You can patient handle with cotton/gauze with alcohol.

Please clean softly OP panel or other parts with wet soft cloth.

Clean the device after turning off the power.

Don’t spray liquid type of cleaning product directly to the device.

5. Handling of waste

It is regular custom to follow the law of each country when handling of waste including devices. Please

follow the regulations of each country.

Message


6. Message

6.1 Error message

Please refer the solutions below when the messages like below come out on OP.

If, below methods do not solve problems and please contact manufacturer

1 Error message kV Low Occurred

Temporary Solution

Please turn off machine and turn on.

2 Error message kV High Occurred

Temporary Solution


3 Error message mA Low Occurred

Temporary Solution


4 Error message mA High Occurred

Temporary Solution


5 Error message OCP

Temporary Solution


6 Error message EPIP

Temporary Solution


7 Error message Tank Overheat (SW)

Temporary Solution

Turning off machine for one hour and use again

8 Error message Tank Overheat (sensor)

Temporary Solution

Turning off machine for one hour and use again

9

Error message Exposure button was released

Temporary Solution

If user press off button by mistake, and after 10 seconds, error message disappear and

processing again

10

Error message Interrupt by something to rotate gantry

Temporary Solution

If user touched rotating part while rotation, after 10 seconds, and error message

disappear and use again

11

Error message Please, recheck laser alignment

Temporary Solution

If Canine Laser is located at back of ear, and after 10 seconds and error message

disappeared and use again.

Message


Please contact to manufacturer when the error messages like below.

No. Error message

1 Gantry rotating overload

2 Y-axis moving overload

3 Ceph detector moving overload

4 Ceph collimator moving overload

5 Collimator moving overload

6 No program at FPGA

7 Exposure program was wrong.

Message


6.2 Condition message

No. Message 설 명

1 Scanning.. Taking a image during rotating

2 Processing Making a quality of image better.

Reorganizing the image for diagnosis.

3 Testing Testing the rotating part.

4 Make by Ready Heating a X-ray tube.

5 Press the switch Exposure X-ray pressing the switch.

6 Returning... Returning the rotating part to starting point.

7 Emergency Pressing emergency button.

8 Technical Mode Setting OP system from PC.

Technical Data

69 User manual

7. Technical Data

7.1 Classification

Electrical classification Class I, Type B

7.2 Power Requirements

Input Power Supply 220 V~

Power Supply Frequency 50/60 Hz

Capacity of Power Supply 2.2 kVA

You are recommended to use AC power to avoid crash of power requirements for other

devices.

7.3 Complied Standards

- IEC/EN 60601-1 - IEC/EN 60601-1-2

- IEC/EN 60601-1-3 - IEC/EN 60601-2-7

- IEC/EN 60601-2-28 - IEC/EN 60601-2-32

Technical Data


7.4 X-ray source assembly

kV range 60~90 kV

mA range 4~12 mA

Exposure time range PANORAMA: max 17sec

CEPH: max 17sec

Total filtration

Inherent Filtration : 0.5 mmAl (OPX-105)

Inherent Filtration : 0.8 mmAl (D-054SB)

Added Filtration : 2mmAl

Total filtration : 2.5mmAl (OPX-105)

2.8mmAl (D-054SB)

Superheated Temperature 50 ℃

7.5 Beam Limiting Device

Material Aluminum + 3.0 mm Pb

Form Rectangle

Technical Data


7.6 Detector

XID-C15DP (Only for Panorama)

Part Items Specifications

Sensor Chip

Sensor Material CdTe, 750 um

Pixel Size (um) 100

Active Area (mm) 150 mm x 4.8 mm

Dynamic Range (dB) ≥ 72dB

DQE(70kV,0lp,mm) ≥ 0.8

MTF(2lp,mm) ≥ 0.8

Electronics

Power Supply Requirement Digital +5 V/1 A, Analog +5 V/1 A

Command I/O 3 TTL trigger

Data I/O GigE

Frame Rate (fps) 200 fps

Data Bits Per Pixel 12 bit

Mechanical

Dimension

Size (mm) 73W*168H*21.05D

Weight (g) 340

XID-C24DC (For Panorama and Cephalo)

Part Items Specifications

Sensor Chip

Sensor Material CdTe, 750 um

Pixel Size (um) 100

Active Area (mm) 240 mm x 4.8 mm

Dynamic Range (dB) ≥ 72dB

DQE(70kV,0lp,mm) ≥ 0.8

MTF(2lp,mm) ≥ 0.8

Electronics

Power Supply Requirement Digital +5 V/1 A, Analog +5 V/1 A

Command I/O 3 TTL trigger

Data I/O GigE

Frame Rate (fps) Pano: 200 fps, Ceph: 125 fps

Data Bits Per Pixel 12 bit

Mechanical

Dimension

Size (mm) 73W*255H*21.7D

Weight (g) 505 g

Technical Data


7.7 Dimensions and Weights

GDP-1

치 수 1040 x 1155 x 2317 mm

중 량 110 kg ± 5%

GDP-1C

치 수 1040 x 1775 x 2317 mm

중 량 140 kg ± 5%

Technical Data


7.8 Movement

Up/Down Movement Movement (Distance) : 700 mm

Speed : 16.7 mm/s

Right/left Movement Movement (Distance) : 170 mm

Speed : 6.8 mm/s

Rotating Angle 220 °

7.9 Other Information

Maximum No. of Exposure (Per an hour) 10 times

X-ray Exposure method Continuous

SID Panorama : 480 mm

Cephalo: 1650 mm

SSD Panorama : 248 mm

Cephalo : 1359 mm

Maximum tube current at maximum tube

voltage 12 mA

Maximum tube voltage at maximum tube

current 90 kV

Tube current and voltage at maximum

power output 90 kV, 12 mA

Minimum mAs 36 mAs

Over current Release Fuse 15A

Ground connection B type Ground

Technical Data


7.10 X-ray Tube

7.10.1 OPX – 105 (CEI)

Type Stationary

Focal Spot 0.5 mm

Target Angle 5 °

Target Material Tungsten

Inherent Filtration 0.5 mmAl

Cooling Method Oil cooling

Nominal Anode Input Energy at 0.1S(DC) 2000 W

Nominal Voltage 110 kV

Thermal Characteristics

Anode Heat Storage Capacity 30 kJ

Maximum Anode Cooling rate 200 W

X-Ray tube characteristic curve

(1) Maximum Rating Charts (Absolute maximum rating charts)

Technical Data


(2) Emission Characteristics

(3) Anode Thermal Characteristics

(4) OPX/105 size (Unit:mm)

Technical Data


7.10.2 D-054SB (Toshiba)

Type Stationary

Focal Spot 0.5 mm

Target Angle 5 °

Target Material Tungsten

Inherent Filtration 0.8 mmAl

Cooling Method Oil cooling

Nominal Anode Input Energy at 0.1S(DC) 1750 W

Nominal Voltage 110 kV

Thermal Characteristics

Anode Heat Storage Capacity 35 kJ

Maximum Anode Cooling rate 250 W

X-Ray tube characteristic curve

(1) Maximum Rating Charts (Absolute maximum rating charts)

Technical Data


(2) Emission Characteristics (3) Anode Thermal Characteristics

(4) D-054SB size (Unit: mm)

Labeling


8. Labeling

8.1 GDP-1

• Hand S/W

• X-ray tube • Beam limiting device • Generator

• Rotating Arm • Laser

• Manufacturer Label • X-ray Support

• Digital Sensor

Labeling


8.2 GDP-1C

• Hand S/W

• X-ray tube

• Beam limiting device • Generator • Rotating Arm • Laser

• Manufacturer Label • X-ray Support

• Digital Sensor

• Detector

Labeling


[Manufacturer label]

- GDP-1

- GDP-1C

Labeling


Maintenance


Appendix 1.

MAINTENANCE

The user needs to check that all safe related the equipment operation before using it.

Routine maintenance

- Machine and parts should be maintained by basic condition.

- Machine and parts should be checked by routine maintenance.

Regular maintenance

- Check list every 1 year

Accuracy of X-ray tube voltage

Accuracy of X-ray tube current

Exposure dose of patient

Maintenance for long break

If the machine is not used for 6 months, the machine should be inspected by manufacturer.

- Check list

Accuracy of X-ray tube voltage

Accuracy of X-ray tube current

Exposure dose of patient

It must be used by a trained professional. This machine is maintained by GENORAY America.

Test method

- Accuracy of X-ray tube voltage

Test instrument: X-ray multi meter

Test method: Measure the tube voltage value and compare setting voltage with measured voltage.

Test limit: The error of the values of the X-ray tube voltage shall be not greater than 10%

- Accuracy of X-ray tube current

Test instrument: Oscilloscope

Test method: Measure the tube current value and compare setting current with measured current.

Test limit: The error of the values of the X-ray tube current shall be not greater than 20%

Maintenance


- Exposure dose of patient

Test instrument: X-Ray multi-meter

Test method: Measured dosimetry.

Test limit: less than 7 mGy (Panorama), 3 mGy (skull AP/PA), 1.5 mGy (skull lateral)

If maintenance parameter is over the limit, some part is changed or repaired in manufacturer’s

judgment.

INSPECTION

PERIOD INSPECTION ITEM INSPECTOR

RESULT

1 2 3 4 5 Remarks

EVERY DAY

On / Off Switch

User

Up/Down, Right/Left buttons

Exposure Hand Switch

Patient Registration

Image Save and Load

EVERY WEEK Temperature & Humidity

Emergency Button

EVERY 1YEARS

Tube Voltage Accuracy Test

Manufacturer

Tube Current Accuracy Test

Exposure Dose to the patient

WHEN THE

MACHINE HAS

NOT BEING

USED FOR 6

MONTH

Tube Voltage Accuracy Test

Tube Current Accuracy Test

Exposure Dose to the patient


GENORAY Co., Ltd.

#512 Byucksan Technopia 434-6 Sangdaewon 1-Dong Jungwon-Gu Seongnam-City Gyeonggi-

Do Korea, 462-716

TEL : +82-31-737-8020 FAX : +82-31-737-8018

www.genoray.com

GENORAY America Inc.

1073 N. Batavia St. Orange, CA 92867 Tel: +1-855-436-6729 Fax : +1-714-786-8919

Obelis s.a.

Boulevard Général Wahis 53, 1030 Brussels, BELGIUM

Tel: +32-2-7325954 Fax: +32-2-7326003

The original version of PAPAYA is being written in Korean

Papaya Manual ENG[1]

Documents

Transcript of Papaya Manual ENG[1]