Papaya Manual ENG[1]

Genoray makes the invisible visible !

www.genoray.com

Dental X-ray Imaging System GDP-1C

ManualEFM6TVBSJP

This Product is Medical Equipment.

The specification above can be changed to improve performance.

]

GDP-1 & GDP-1C

Copyright© 2012 2013 / 5 / 31 Document Ver. 0.1

Table of Contents

TablCFG%QPtenKFQs Introducion CN Manual ...................................................................................................................................................................................... 4 CertificaFQ FG)CTCPVsC ......................................................................................................................................................................................5 SsmbolQU usCFQUGPGN productQ.................................................................................................................................................................. 6 #FXGTVGPEKCUCPVGUFGNWUQ.............................................................................................................................................................................. 7 5GIWTKFCF'NoEVTKEC............................................................................................................................................................................................... 8 5GIWTKFCFFG4CFKCEKxP.................................................................................................................................................................................... 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.

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

PAPAYA PLUS User manual

Table of contents 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

7.

6.1

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

6.2

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

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


3

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: +82-31-737-801 8

E - mai l: g en ora y@g eno ra y. com Address:

#512

Byucksan

Techn opia

434-6,

Sangdaewon

1-Dong,

Jungwon -Gu,

S eongnam-Cit y, Gyeongg i-Do, Ko rea

4


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.


5

Electrical Safety

Symbols used in product

Symbol

description X-Ray Source Assembly, X-ray radiation

Symbol

description

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.

6


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.


7

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.

8


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.


9

PAPAYA Equipment Introduction

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.

10



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 Image Acquisition / Angle (Standard panoramic)

Panorama: 4.8mm x 150mm Ceph: 4.8mm x 240mm 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)

11


1.3 System Basic Specification

GDP-1C

Hand Switch

PC

Ethernet

[ System Connection Image ]

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

12



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.

9

3

9

4 6

13 10 5 7 8 11

2

12

1

[ GDP-1 ] No.

[ GDP-1C ] 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

Detector (Panorama, Cephalo using for

12

Emergency stop switch

both, detachable structure)

13

Device status LED

6


Hand Switch (Exposure button, Emergency stop switch)

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.

14



1.6 Patient Apply Part

Cephalo part

Panorama part

Bite

Chin

rest

Temple support

Nasal positional

Patient

handle

Ear rod

After exposure, sanitize patient apply part.


15


1.7 On / Off Switch

OFF

ON

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.

16



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

emergency

switch

two functions together. is

used

when

While

equipment

X-ray

exposure

switch

is

malfunctioning or it can harm patient. At moment, equipment will stop.

Emergency stop switch

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.


17


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.

18



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.


19


1.11

Laser Control Knob

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.

20



1.12 Changing Detector This equipment is according to exposure mode, detector needs to move. When to exposure Panorama Detector’s Location

When to exposure Cephalo Detector’s Location

 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.


21

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

22

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.

9

1

11

2 3

4

12

5

6

10

7

8

[ Operation Panel Program / Main Screen ]


23


No. 1 2 3 4 5 6 7 8

Subject Exposure

Time

description Display

Screen Patient’s

Information

Display Screen Exposure

Mode

Choose

Button Exposure Program Choose Button Patient’s

Size

Choose

Quality

Choose

Button Image Button Exposure Condition Display and Change Part Equipment

Movement

Displaying current time. Displaying patient’s information who wait for current exposure. Choosing equipment’s exposure mode. Choosing equipment’s exposure mode by exposure program. Choosing according to patient’s size by pre-set value. Deciding exposure image’s quality. Controlling equipment’s exposure condition manually. Deciding

exposure

condition

and

preparation

Button Part

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

completion

and

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.

24



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.

2.2.1Panorama program Exposure Mode

Mode Type Program Standard Panoramic Standard panoramic has standard panorama’s image field of view and Taking exposure.

Panorama mode 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.


25


Exposure Mode

Mode Type Program  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 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 mode

 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.

26



Exposure Mode

Mode Type Program  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 Midsagittal Sinus midsagittal exposure enables to take exposure of maxillary sinus and use it. The image’s focus is on midsagittal surface.

Sinus mode

 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.


27


Exposure Mode

Mode Type Program  Sinus PA Sinus PA takes an exposure at PA’s direction of maxillary sinus.

28


OP (Operation Panel) 2.2.2Cephalo Program Exposure Mode

Mode Type Program 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 mode

Cephalo PA Cephalo PA exposure is that at toward PA’s direction, X-ray penetrate and taking exposure of skull.


29


Exposure Mode

Mode Type Program  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.

30



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.

Normal

Fast

HD ( High Definition)

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

2.5 Selection of Jaw shape Sharp

Normal Square

Small

Average Large

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).


31


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 2

1

3

4

5

32


OP (Operation Panel) 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 Displaying patients’ information of registered order by following selected filtration option.

1

Order status filter

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. Managing order. Register: Executing order registration window.

5

Order management button

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.


33


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.

34


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


35

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 Setting Multi Focus using or not using

Multi Focus

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

Automatically setting processing / no processing Auto Process

36

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 SQL Server Information

Data folder Information

Explanation Server Name

Setting Order DB's usage path

Triana Server Name

Setting DB path at Triana

Temp Image

At PAPAYA OP, setting saved image path

Triana Image Parameter

Trouble shoot


At Triana, by managing image, making im age saving path Setting parameter path

When problem happens, pushing button to solve problem.

37

Image acqusition 2.9.3 DB Server

Name

38

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


39

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

patient Click

information

registration

the

patient

in

window.

registration

after done.

A. OP operation [ Panorama ]

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

[ Cephalo ]

of the device including cephalo function, you can choose one between panorama & cephalo. Order information will be registered when you click the acquisition button.

40


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.


41

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.

2. [ For regular teeth ] Set chin-rest & bite on the device. The patient who doesn’t have teeth or hard to bite [ For regular teeth ]

[For patient without teeth]

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.

42


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.


43

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.

44


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.


45

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

2. the chin-rest [for TMJ mode]

[ For TMJ mode ]

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, neck tie for the safety.

46


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.



47

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.


) of device set button while the patient

stands on 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


48


Image acquisition



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.

11. Finally move the position of laser by using ‘FORWARD’ & ‘BACKWARD’ button on patient control button to be canine laser positioned on TMJ of patient. ‘FORWARD’ button moves to user’s direction but ‘BACKWARD’ button moves to opposite direction of user’s.



49

Image acqusition


50


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.


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

[ for Sinus mode ]

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, neck tie for the safety.


51

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.


52


Image acquisition 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.


) of device set button while the patient stands

on 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


53

Image acqusition




11. Finally move the position of laser by using ‘FORWARD’ & ‘BACKWARD’ button on patient control button to be canine laser positioned on Sinus of patient. ‘FORWARD’ button moves to user’s direction but ‘BACKWARD’ button moves to opposite direction of user’s.


54


Image acquisition



55

Image acqusition

3.5 Cephalo mode patient position set

1. Set detector on cephalo position.


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, 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.

56


Image acquisition


4. Set the height by using 1.10 device control button after being the patient positioned. 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.



57

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

58


Image acquisition When the exposure starts, OP shows X-ray warning message & the image taking, and final image comes out again after the complete.


59

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 down

60

View 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.


61

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.

62


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.


63

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.)

64


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.


65

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 Temporary Solution Error message

2

Temporary Solution Error message

3


4


5


6


7


8


9


10


11

66

Temporary Solution

kV Low Occurred Please turn off machine and turn on. kV High Occurred Please turn off machine and turn on. mA Low Occurred Please turn off machine and turn on. mA High Occurred Please turn off machine and turn on. OCP Please turn off machine and turn on. EPIP Please turn off machine and turn on. Tank Overheat (SW) Turning off machine for one hour and use again Tank Overheat (sensor) Turning off machine for one hour and use again Exposure button was released If user press off button by mistake, and after 10 seconds, error message disappear and processing again Interrupt by something to rotate gantry If user touched rotating part while rotation, after 10 seconds, and error message disappear and use again Please, recheck laser alignment 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.


67

Message

6.2 Condition message No.

68

Message

설 명

1

Scanning..

Taking a image during rotating

2

Processing

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.

Making a quality of image better. Reorganizing the image for diagnosis.


Technical Data

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

69

- 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

User manual

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 Inherent Filtration : 0.5 mmAl (OPX-105) Inherent Filtration : 0.8 mmAl (D-054SB)

Total filtration

Added Filtration : 2mmAl Total filtration : 2.5mmAl (OPX-105) 2.8mmAl (D-054SB)

Superheated Temperature

50 ℃

7.5 Beam Limiting Device

70

Material

Aluminum + 3.0 mm Pb

Form

Rectangle


Technical Data

7.6 Detector  XID-C15DP (Only for Panorama) Items

Specifications

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

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

Size (mm)

73W*168H*21.05D

Dimension

Weight (g)

340

Part

Sensor Chip

Electronics

 XID-C24DC (For Panorama and Cephalo) Items

Specifications

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

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

Size (mm)

73W*255H*21.7D

Dimension

Weight (g)

505 g

Part

Sensor Chip

Electronics


71

Technical Data

7.7 Dimensions and Weights  GDP-1 치

수

1040 x 1155 x 2317 mm

중

량

110 kg ± 5%

 GDP-1C

72

치

수

1040 x 1775 x 2317 mm

중

량

140 kg ± 5%


Technical Data

7.8 Movement

Up/Down Movement

Right/left Movement

Rotating Angle

Movement (Distance) : 700 mm Speed : 16.7 mm/s Movement (Distance) : 170 mm Speed : 6.8 mm/s 220 °

7.9 Other Information Maximum No. of Exposure (Per an hour)

10 times

X-ray Exposure method

Continuous

SID

SSD Maximum tube current at maximum tube voltage Maximum tube voltage at maximum tube current Tube current and voltage at maximum power output

Panorama : 480 mm Cephalo: 1650 mm Panorama : 248 mm Cephalo : 1359 mm 12 mA 90 kV 90 kV, 12 mA

Minimum mAs

36 mAs

Over current Release

Fuse 15A

Ground connection

B type Ground


73

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)

74


Technical Data (2) Emission Characteristics

(3) Anode Thermal Characteristics

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


75

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)

76


Technical Data

(2) Emission Characteristics

(3) Anode Thermal Characteristics

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


77

Labeling

8. Labeling 8.1 GDP-1

• Digital Sensor

• X-ray tube • Beam limiting device • Generator • Rotating Arm • Hand S/W

• Laser

• Manufacturer Label • X-ray Support

78


Labeling

8.2 GDP-1C

• Digital Sensor

• X-ray tube • Beam limiting device • Detector

• Generator • Rotating Arm • Laser

• Hand S/W

• Manufacturer Label • X-ray Support


79

Labeling [Manufacturer label]

- GDP-1

- GDP-1C

80


Labeling


81

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%

82


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

INSPECTION ITEM

PERIOD

INSPECTOR

RESULT 1

2

3

4

5

Remarks

On / Off Switch Up/Down, Right/Left buttons EVERY DAY

Exposure Hand Switch Patient Registration

User

Image Save and Load Temperature & Humidity EVERY WEEK Emergency Button Tube Voltage Accuracy Test EVERY 1YEARS

Tube Current Accuracy Test Exposure Dose to the patient

WHEN THE MACHINE HAS NOT BEING USED FOR 6 MONTH

Manufacturer Tube Voltage Accuracy Test Tube Current Accuracy Test Exposure Dose to the patient


83

GENORAY Co., Ltd. #512 Byucksan Technopia 434-6 Sangdaewon 1-Dong Jungwon-Gu Seongnam-City GyeonggiDo 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

84


Papaya Manual ENG[1]

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