GENORAY PAPAYA User manual

DENTAL X-ray Imaging System
&
User's Manual
2017.09.13 Document Ver.1.2
Copyrightⓒ2015 by GENORAY Co.,Ltd. All Rights Reserved

Contents
PAPAYA User’s Manual (ver 1.2) 1 / 99
Contents
1. Introduction of Product................................................................................................................ 6
1.1 Introduction of Product............................................................................................................................................................................................ 6
1.2 Warning before use.................................................................................................................................................................................................... 7
1.3 Electrical safety............................................................................................................................................................................................................. 8
1.4 Radiation Safety.........................................................................................................................................................................................................10
1.5 Overheat equipment................................................................................................................................................................................................11
1.6 Use condition..............................................................................................................................................................................................................12
1.7 Treatment of waste...................................................................................................................................................................................................12
2. PAPAYA Composition................................................................................................................... 13
2.1 Structure and appellation ......................................................................................................................................................................................13
2.2 Accessories...................................................................................................................................................................................................................14
2.2.1 Chin rest.............................................................................................................................................................................................................14
2.2.2 Chinrest change method ............................................................................................................................................................................14
2.3 On / Off Switch ..........................................................................................................................................................................................................15
2.4. Exposure switch.........................................................................................................................................................................................................16
2.4.1 Hand switch......................................................................................................................................................................................................16
2.5 Device status LED......................................................................................................................................................................................................17
2.6 EMERGENCY SWITCH ..............................................................................................................................................................................................18
2.7 Equipment’s Control Button .................................................................................................................................................................................19
2.7.1 CUST mode Control button ......................................................................................................................................................................20
2.8 2nd Equipment control Button ...........................................................................................................................................................................21
2.9 Lase control knob .....................................................................................................................................................................................................22
2.10 Position of detector ...............................................................................................................................................................................................23
2.10.1 Detector Install & remove.......................................................................................................................................................................23
2.11 Device status LED ...................................................................................................................................................................................................24
2.12 Patient supporting part........................................................................................................................................................................................25
3. OP (Operation panel) .................................................................................................................. 26
3.1 OP structure.................................................................................................................................................................................................................26
3.2 X-ray Exposure Mode..............................................................................................................................................................................................27
3.2.1 Panoramic..........................................................................................................................................................................................................28
3.2.2 Cephalo ..............................................................................................................................................................................................................31
3.2.3 CUST (Option) .................................................................................................................................................................................................33
3.3 Patient size...................................................................................................................................................................................................................35
3.4 Exposure Speed and Change of Image Quality...........................................................................................................................................35
3.5 X-ray exposure condition setting.......................................................................................................................................................................35
3.6 Device condition display screen .........................................................................................................................................................................36
3.7 Selection of Jaw shape ...........................................................................................................................................................................................36
3.8 Order list .......................................................................................................................................................................................................................37

Contents
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3.8.1. Order registration .........................................................................................................................................................................................38
3.9 Option setting ............................................................................................................................................................................................................39
3.9.1 General ...............................................................................................................................................................................................................40
3.9.2 DB Server...........................................................................................................................................................................................................41
3.9.3 DICOM................................................................................................................................................................................................................42
4. Image acquisition......................................................................................................................... 43
4.1 Image acquisition......................................................................................................................................................................................................43
4.1.1 Triana software................................................................................................................................................................................................43
4.2.2 OP execution....................................................................................................................................................................................................45
4.2 Panoramic mode positioning of the patient.................................................................................................................................................46
4.3 TMJ mode patient positioning set ....................................................................................................................................................................50
4.4 Sinus mode patient positioning set..................................................................................................................................................................54
4.5 Cephalo mode position of patient ....................................................................................................................................................................58
4.6 CUST mode position of patient (Option) .......................................................................................................................................................60
4.7 Image taking ...............................................................................................................................................................................................................66
4.8 Condition message...................................................................................................................................................................................................69
4.9 Image Control.............................................................................................................................................................................................................70
4.10 TWAIN interface ......................................................................................................................................................................................................71
4.11 OP additional function .........................................................................................................................................................................................72
4.11.1 Sending to DICOM server .......................................................................................................................................................................72
4.11.2 Burning CD.....................................................................................................................................................................................................72
4.11.3 Register addition order.............................................................................................................................................................................73
4.11.4 Opening of patient’s folder.....................................................................................................................................................................73
5. Precautions after using, Methods of storage and maintain .............................................. 74
5.1 Cleaning and Method .............................................................................................................................................................................................74
5.2 Storage...........................................................................................................................................................................................................................74
5.3 Maintain ........................................................................................................................................................................................................................74
6. Product contents.......................................................................................................................... 75
6.1 Classification and complied standards ............................................................................................................................................................75
6.1.1 Classification.....................................................................................................................................................................................................75
6.1.2 Complied standards......................................................................................................................................................................................75
6.2 Power and other information ..............................................................................................................................................................................76
6.3 Specifications of main part...................................................................................................................................................................................77
6.3.1 X-ray source assembly.................................................................................................................................................................................77
6.3.2 X-ray tube .........................................................................................................................................................................................................78
6.3.3 Detetor................................................................................................................................................................................................................82
6.4 Dimensions and Weights.......................................................................................................................................................................................84
6.5 Labeling.........................................................................................................................................................................................................................85
6.5.1 Manufacturer label ........................................................................................................................................................................................86
6.5.2 Manufacture label..........................................................................................................................................................................................88

Contents
PAPAYA User’s Manual (ver 1.2) 3 / 99
Appendix 1. Error message & temporary countermeasure .................................................... 89
Appendix 2. Maintenance............................................................................................................... 96
Appendix 3. X-ray exposure table & DAP(Dose area product) ............................................. 97

About this manual
4 / 99 PAPAYA User’s Manual (ver 1.2)
This manual contains a general description and other information about the use PAPAYA, PAPAYA PLUS.
Please read this manual thoroughly for safe and effective use of the equipment.
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.
Symbols used in Manual
This manual includes instructions and warnings.
Please check carefully what has been symbol displayed below.
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.
Federal law restricts this device to sale by or on the order of physicians and dentists.
(Only U.S.A)

About this manual
PAPAYA User’s Manual (ver 1.2) 5 / 99
Symbols used in product
Symbol Description Location
AC (Exchange)
Ground Boards
OFF On/Off switch
ON On/Off switch
X-Ray Source Assembly, X-ray Exposure Label
Warning: dangerous voltage GENERATOR
WEEE Mark Label
Laser Equipment
Please refer to the user manual Label
Name of manufacturer, address Label
Manufacturing date Label
Authorized representative in the European
community Label
Product serial number Label
The CE symbol indicates that this product complies
with the European Directive for Medical Devices
93/42/ EEC as amended by 2007/47/EC as a class
IIb device.
Label

1. Introduction of Product
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1. Introduction of Product
1.1 Introduction of Product
PAPAYA Plus is a digital extraoral source X-ray system intended to produce panoramic and cephalometric(option)
images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The
system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by
exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both
panoramic and cephalometric images.
PAPAYA is able to be capable of shooting panoramic image and PAPAYA PLUS is able to be
capable of shooting cephalometric and panoramic image.
Features of PAPAYA Plus
Dental Arch selection function of a variety of patients
Choice of image quality and shooting speed
Setting function of the best X-Ray irradiation conditions for each patient
Minimize the exposure dose of the patient in control of the sectional X-Ray exposure
Shooting various modes for a complete analysis of the TMJ
Use of Tomography shooting function is possible with the addition of software and hardware
upgrade. (Optional)

1. Introduction of Product
PAPAYA User’s Manual (ver 1.2) 7 / 99
1.2 Warning before use
The user is responsible for the maintenance and operation of the device. Please refer to
“appendix .2 Maintance”
The electric circuit of this product uses the electric current which can cause death due to
severe injury or electric shock. Please read how to use that is provided in this manual,
such as the remedy of emergency, safety notes.
 This machine need to operate after studying of manual.
 Never let anyone remove the cover
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 and do not adjust the machine.
It requires patient to remove the metal product the patient is wearing before shooting,
such as hearing aids, dentures, dentures, hairpins, and other accessories. If you take a
picture with the object as described above, there may be reflection or shadow image is
displayed on the image. For your safety, scarf, scarves, ties, etc., it is recommended that
you remove it.
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.
Do not modify this equipment without authorization of the manufacturer.

1. Introduction of Product
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1.3 Electrical safety
Before using 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).
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth
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.
For reducing the risk of electrical shock, and when connecting to power, there needs protecting ground
connection.
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.

1. Introduction of Product
PAPAYA User’s Manual (ver 1.2) 9 / 99
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.
Turn off the power and unplugged when you are not using the machine.
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.
Please acknowledge how to use the fire extinguisher for precaution.
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.
This product generates the electromagnetic energy. If the product is affected by electromagnetic interference,
turn off the power and change the location of the product.
In this case, It should be connected to another socket. If you need help, please contact our service center.

1. Introduction of Product
10 / 99 PAPAYA User’s Manual (ver 1.2)
1.4 Radiation Safety
Must comply with all radiation laws and regulations with the local jurisdiction.
When taking exposures, the x-ray room of the floor, wall material and radiation protection must be strengthened.
When taking exposures, operators and service personnel must protect themselves from radiation.
Protect the patient from scattered radiation by placing a protective lead apron over the patient.
When taking an X-ray exposure of a child or pregnant woman, consult a doctor.
Always comply with recommended X-ray dose when taking an X-ray exposure of a child.
Before taking an exposure, ask any female patient of childbearing age whether she might be pregnant.
All patients must be provided with a shielded apron for gonad protection .
Avoid unnecessary exposure, use suitable collimation fit according to body type of child.
Avoid additional exposures by unnecessary movement of a child, must be accompanied by an adult.
Precautions for the patient is a using pacemaker, artificial heart,
Malfunction can occur when taking a pulsed X-ray exposure continuasly.
Avoid exposure directly to the part of the pacemaker and ariticicial heart. Always use the lowest possible x-ray
dose.
The unit may be dangerous to the user and the patient, if the safety regulations and standard procedures in
this manual ignored.

1. Introduction of Product
PAPAYA User’s Manual (ver 1.2) 11 / 99
1.5 Overheat equipment
Overheating of the high voltage generator, a warning is displayed below.
10℃ ~ 54℃ Green => X-RAY exposure possible.
Upper than 55℃ Red => X-RAY exposure impossible
(high voltage generator is overheated)
When the high-voltage generator is overheated, please turn off the equipment. It has to have a cooling time of
2-3 hours. After then turn on the power, please make sure that it is ready for exposure.
There is a possibility that when you use continuously without cooling time of the product, damage
occurs in the X-ray tube, please use it to protect the Cooling Time After exposuring.

1. Introduction of Product
12 / 99 PAPAYA User’s Manual (ver 1.2)
1.6 Use condition
1) Condition of movement & Storing
- Temperature : -20°C ~ 60°C
- Relative humidity: 5% ~ 95% RH (But, No dew condensation)
- Air pressure : 500 ~ 1100 hPa
2) Condition of movement when using
- Temperature: 15°C ~ 30°C
- Relative humidity : 5% ~ 75% RH (But, No dew condensation.)
3) 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.
1.7 Treatment 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
1) X-ray tube : Industrial waste disposal facility
2) Metal Frame : Recycle
3) Plastic : Recycle
4) PCB & Boards : Industrial waste disposal facility.

2. PAPAYA Composition
PAPAYA User’s Manual (ver 1.2) 13 / 99
2. PAPAYA Composition
2.1 Structure and appellation
This machine has panoramic only model of PAPAYA and has added cephalo exposure that is PAPAYA
Plus. Each model’s composition or exterior, please refer to below pictures.
1) Fixed column 8) On/off Switch
2) Driving Unit 9) Hand Switch
3) Gantry Unit 10) Emergency stop switch
4) X-ray source assembly 11) Device status LED
5) Detector 12) Cephalomatric Arm (PAPAYA Plus)
6) Patient supporting area 13) Cephalomatric Unit (PAPAYA Plus)
7) Equipment’s control button 14) 2nd Equipment’s control button (PAPAYA PLUS)

2. PAPAYA Composition
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2.2 Accessories
2.2.1 Chin rest
Patient’s condition or according to exposure mode, chin rest can be changeable.
[Standard Exposure][For No Teeth Patient]
[ SINUS & TMJ mode Mode ] [CUST mode ]
2.2.2 Chinrest 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.

2. PAPAYA Composition
PAPAYA User’s Manual (ver 1.2) 15 / 99
2.3 On / Off Switch
On/Off switch is located at eqipment’s below part.
If turning on equipment’s switch, and the equipment’s LED has light and displays equipment’s waiting condition.
It needs to have warming up time for using this machine.
If there is a false indication on the main screen or indicator, because it may give a risk to user and patient,
please contact our service center immediately.

2. PAPAYA Composition
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2.4. Exposure switch
2.4.1 Hand switch
Hand switch can be hung on the wall. It has a X-ray exposure switch and a emergency stop switch. While
emergency switch is used when equipment is malfunctioning or it can harm patient.
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.

2. PAPAYA Composition
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2.5 Device status LED
LED will light various color depending on equipment’s status.
It is on the equipment and hand switch hanger.
LED Color description
Blue Rotating side is at rotation
Yellow while X-ray exposure
Green When X-ray exposure, ready
Red While taking exposure, error occurs or pushing emergency switch

2. PAPAYA Composition
18 / 99 PAPAYA User’s Manual (ver 1.2)
2.6 EMERGENCY SWITCH
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.
- Emergency stop switch is located at above picture.
- Pushing emergency button can let machine stop.
- Device will be restarted by turning in the direction of the arrow.
This button should be use for emergency situation.

2. PAPAYA Composition
PAPAYA User’s Manual (ver 1.2) 19 / 99
2.7 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.
Do not adjust the machine during operation.
Controlling equipment’s height
LIFT DOWN
LIFT UP
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 : moving gentry to user.
BACKWARD : moving genty, opposite side to user..