Vatech PaX-i3D Smart, PHT-30LFO User Manual

Download

Postal Code: 445-170

13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea

(PHT-30LFO)

User Manual Version 1.2.0

English

"i" stands for 'innovation', one of the core values of VATECH, which aims to expand accessibility of medical solutions to more people.

Notice

Thank you for purchasing the PaX-i3D Smart extra-oral imaging system.

The PaX-i3D Smart is an advanced digital dental diagnostic system that incorporates PANO, CEPH, and CBCT imaging capabilities into a single system.

This manual describes how to operate the PaX-i3D Smart system. It is recommended that you thoroughly familiarize yourself with this manual in order to make the most effective use of this equipment.

Observe all cautions, safety messages and warnings which appear in this manual.

Due to a constant technological improvement, the manual may not contain the most updated information, subjecting to change without prior notice to the persons concerned. For further information not covered in this manual, please contact us at:

English

VATECH Co., Ltd.

Phone: +82-1588-9510

E-mail: gcs@vatech.co.kr

This document is originally written in English.

The PaX-i3D Smart is referred to as Equipment in this manual.

Manual Name: PaX-i3D Smart (Model: PHT- 30LFO) User Manual

Version: 1.2.0

Publication Date: 2015-2

PaX-i3D Smart

v I

Table of Contents

1. General Information .............................................................................2

1.1 Manufacturer’s Liability .........................................................................................2

1.2 Owner and Operator’s Obligations ........................................................................ 2

1.3 Conventions in this Manual ................................................................................... 3

1.4 Marks and Symbols ..............................................................................................4

2. Warnings and Precautions ..................................................................6

2.1 General Safety Precautions ...................................................................................6

2.2 Electricity-related Safety Precautions ....................................................................9

2.3 Radiation Safety ................................................................................................. 11

2.4 Warnings ............................................................................................................ 12

3. Imaging System Overview ................................................................. 18

3.1 Introduction ........................................................................................................ 18

3.2 Imaging System Configuration ............................................................................ 21

3.3 Equipment Overview ........................................................................................... 23

4. Imaging Software Overview ..............................................................32

4.1 PC Specifications ............................................................................................... 32

4.2 EasyDent / EzDent-i .......................................................................................... 34

4.3 Console Software ............................................................................................... 35

5. Getting Started ..................................................................................42

5.1 Turning On Equipment ........................................................................................ 42

5.2 Running the Image Viewer .................................................................................. 44

5.3 Initiating the Console Software ............................................................................50

6. Acquiring PANO images ....................................................................54

6.1 Setting Exposure Parameters ............................................................................59

6.2 Patient Positioning .............................................................................................. 63

6.3 X-ray Exposure ................................................................................................... 77

6.4 Finishing Scan .................................................................................................... 78

6.5 Confirming Image ............................................................................................... 78

PaX-i3D Smart

vi I

Table of Contents

7. Acquiring CEPH images ...................................................................80

7.1 Setting Exposure Parameters .............................................................................82

7.2 Patient Positioning .............................................................................................. 85

7.3 X-ray Exposure ................................................................................................... 95

7.4 Finishing Scan .................................................................................................... 96

7.5 Confirming Image ............................................................................................... 96

8. Acquiring CT Images ...........................................................................98

8.1 Setting Exposure Parameters .............................................................................98

8.2 Patient Positioning ............................................................................................ 101

8.3 X-ray Exposure ................................................................................................. 106

8.4 Finishing Scan .................................................................................................. 108

8.5 Confirming Image ............................................................................................. 108

9. Troubleshooting ............................................................................... 110

10. Cleaning and Maintenance .............................................................. 114

10.1 Cleaning ........................................................................................................... 114

10.2 Maintenance ....................................................................................................115

English

11. Disposing of the Unit ....................................................................... 118

12. Technical Specifications .................................................................120

12.1 Mechanical Specifications ................................................................................120

12.2 Technical Specifications ................................................................................... 125

12.3 Electrical Specifications .................................................................................... 129

12.4 Environmental Specifications ............................................................................129

13. Appendices ......................................................................................132

13.1 Recommended X-ray Exposure Table ...............................................................132

13.2 X-ray Dose Data ............................................................................................... 135

13.3 Electromagnetic Compatibility (EMC) Information .............................................139

13.4 Acquiring image for the pediatric dental patient ................................................. 142

13.5 Abbreviations ..................................................................................................145

PaX-i3D Smart

vii I

General Information

1.1 Manufacturer’s Liability .....................2

1.2 Owner and Operator’s Obligations ....2

1.3 Conventions in this Manual ...............3

1.4 Marks and Symbols ..........................4

1. General Information

1.1

Manufacturer’s Liability

The manufacturers and/or retailers of this equipment assume responsibility for the safe and normal operation of this product only when:

● The equipment has been installed by a VATECH authorized technician.

● The equipment has been installed in accordance with all of the cautions and conditions for installation.

● Genuine VATECH approved equipment and components have been used at all times.

● All maintenance and repairs have been performed by a VATECH authorized agent.

● The equipment has been used normally in accordance with the user’s manual.

● The equipment damage or malfunction is not the result of an error on the part of the owner or operator.

1.2

Owner and Operator’s Obligations

● The owner of this equipment shall perform constancy tests at regular intervals in order to ensure patient and operator safety. These tests must be performed in accordance with local X-ray safety regulations.

● The owner of this equipment shall perform regular inspection and maintenance of the mechanical and electrical components in this equipment to ensure safe and consistent operation (IEC 60601-1). The owner of this equipment shall ensure inspection and cleaning works are performed in accordance with the maintenance schedule outlined in Chapter 8 Cleaning and Maintenance.

PaX-i3D Smart

2 I

1. General Information

1.3

Conventions in this Manual

The following symbols are used throughout this manual. Make sure that you fully understand each symbol and follow the instructions which accompany it.

To prevent personal injury and/or damage to the equipment, please observe all warnings and safety information included in this document.

Indicates information that should be followed with

WARNING

CAUTION

X-ray

IMPORTANT

the utmost care. Failure to comply with a warning may result in severe damage to the equipment or physical injury to the operator and/or patient.

Indicates a situation that demands prompt and careful action, a specific remedy, or emergency attention.

Indicates a possible danger of exposure to radiation.

Indicates a situation or action that could potentially cause problems to the equipment and/or its operation.

English

NOTE

SINGLE USE

Emphasizes important information or provide useful tips and hints.

Indicates a component which must be replaced for each new patient.

PaX-i3D Smart

3 I

1. General Information

1.4

Marks and Symbols

Symbols Description Location

Alternate current -

Attention: consult accompanying documents Label

Dangerous voltage Power board

Protective earth (Ground) Power board

Off (power: disconnect from the main switch) Main switch

On (power: connect to the main switc Main switch

IEC60601-1 Degree of Protection from Electric Shock TYPE B Equipment

Label

CLASS 1 LASER PRODUCT

Radiation hazard Label

EC representative 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.

UL mark: UL 60601-1 / CAN/CSA C22.2 No.601.1 3ZY1

Address where the equipment was manufactured Label

This symbol indicates that electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately

This symbol warns ESD hazard.

This symbol indicates that this equipment is classified as a CLASS 1 LASER PRODUCT in accordance with IEC 60825-1 ED.1 regulations.

Date of manufacture Label

Refer to Instruction manual Label

Label

MCU board/Board package

Label

PaX-i3D Smart

4 I

Warnings and

Precautions

2.1 General Safety Precautions ...............6

2.2 Electricity-related Safety Precautions 9

2.3 Radiation Safety ..............................11

2.4 Warnings .........................................12

2. Warnings and Precautions

Be sure to strictly observe all warnings and safety instructions included in this manual.

2.1

General Safety Precautions

Operator qualifications

❚

This equipment may only be operated by personnel fully trained in its operation.

● To operate this equipment, all operators must:

— have read and understood the user’s manual — be familiar with the fundamental structure and functions of this equipment — be able to recognize irregularities in the operation of this equipment and implement

appropriate measures to remedy such irregularities.

General safety precautions

❚

● Follow the instructions specified in this manual to ensure the safety of both the patient and the operator.

● The operator must maintain visual contact with the patient at all times during imaging.

● Do not open or remove the cover panels on this equipment. Always have a trained and authorized service technician carry out inspection and maintenance of this equipment.

● Do not place foreign objects on this equipment at any time.

● Do not place any objects within this equipment’s field of operation.

● Do not push or pull the equipment. If equipment overbalances, resulting in the risk of physical injuries or property damage.

● Operators must ask the patient to remain still until the equipment arm has stopped moving and the reset motion is complete.

PaX-i3D Smart

6 I

2. Warnings and Precautions

● Observe all local fire regulations. Always keep a fire extinguisher near the equipment.

● The operator of this equipment must be familiar with this equipment’s emergency protocols.

● Ensure that this equipment is kept away from water, moisture, or foreign substances at all times.

● If this product is exposed to water, moisture, or a foreign substance, immediately turn off all power to the equipment and contact your VATECH technical support representative.

● Immediately cease all operation of this equipment if there are signs of oil leakage and contact you VATECH technical support representative.

Ventilation

❚

● Do not obstruct the equipment’s ventilation for air opening. Improper ventilation could result in the equipment overheating due to a lack of air circulation.

● Do not spray any type of liquid or aerosol on this equipment as this may penetrate the system and damage the electrical and mechanical components inside.

English

● Always leave a sufficient amount of space around the PC to allow for proper ventilation.

Hygiene

❚

Always disconnect the equipment from the power outlet when cleaning the surfaces of the equipment.

● All removable patient support components (bite block, chin support, temple supports) can be cleaned using alcohol-based cleaning solutions.

● Patient support handles can be cleaned using alcohol-based cleaning solutions.

● Other surfaces of the equipment can be cleaned using a soft cloth dampened with a mild cleaning solution.

PaX-i3D Smart

7 I

2. Warnings and Precautions

● New hygiene cover must be provided for each new patient to prevent the transmission of communicable disease.

Do not use aerosol or spray cleaning agents directly on the surface of the equipment.

Condensation

❚

● Extreme fluctuations in temperature may cause condensation to develop inside the equipment. Do not turn on the equipment until it has reached room temperature.

Cooling

❚

● Allow the proper amount of cool down time (for the X-ray tube to cool down) to elapse between each image acquisition.

— Mode of operation: Continuous operation with intermittent loading. — Exposure time: Max. 18 s / Resting time: 5 min. — Column operation time: 1 min / Resting time: 9 min

● If the temperature inside the tube head reaches 60 °C, X-ray exposure will cease and an error message will be displayed. Normal X-ray capabilities will resume after the generator reaches 58 °C (136.4 °F).

● If the fan (optional) is installed, it operates automatically when the temperature surrounding the tube head reaches the pre-defined level: 40 °C (104 °F). The set point temperature is configurable.

Turning the equipment on / adjusting the height of the

❚

equipment

● Do not position the patient in the equipment while it is initiating as the patient could be injured if the equipment malfunctions.

● Ensure that the patient is kept clear of the mechanism while adjusting the height of the equipment.

PaX-i3D Smart

8 I

2. Warnings and Precautions

Emergency stop

❚

● If a problem occurs during image acquisition, press the red emergency stop button to immediately stop all moving parts and cut off all power to the equipment.

Trouble-free operation

❚

● Never use this equipment in an environment that is susceptible to explosion.

● Always operate the equipment within a temperature range of 10 °C to 35 °C (50 °F to 95 °F) for the safe operation. Image quality may deteriorate if the equipment is operated outside of this range.

● Always allow the equipment sufficient time to warm up (while switched on) if it has been exposed to temperatures of below 10 °C (50 °F).

● Only perform X-rays of patients if system is in full working order.

● Always ensure that equipment movement is not obstructed by the patient’s clothing, medical device (such as a wheelchair), or the patient themselves.

● Do not leave the patient unattended around the equipment.

● Remove all radio-controlled devices, mobile phones, etc. from the X-ray room prior to image acquisition as these objects may cause the equipment to malfunction.

English

Modifying the equipment

❚

● Modifying the equipment in any way which may affect the safety of the operator, patient or other persons is prohibited by law.

● No part of this equipment is serviceable by the user. All maintenance and repair of this equipment must be performed by a qualified service technician.

● This product may only be operated with original VATECH accessories or third-party accessories expressly approved by VATECH.

2.2

Electricity-related Safety Precautions

● Check the status of the power source, PC and cables prior to operating the equipment.

● Ensure that the on/off switch is set to off when the equipment is not in use.

● Always disconnect the power supply before cleaning the equipment.

● Always keep electrical cords away from hot appliances or radiators.

PaX-i3D Smart

9 I

2. Warnings and Precautions

● DO NOT place the PC or peripheral equipment connected to the PC in the immediate vicinity of the patient.

● The equipment and PC should be connected to a common protective earth.

● Never overload the equipment’s circuit by sharing it with too many appliances.

● Use the same power circuit for the PC and the equipment.

Combining this equipment with other devices

❚

● Do not connect this equipment to devices which are not part of the system.

● Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO) or extension cord.

Electromagnetic compatibility

❚

● This equipment complies with IEC standard 60601-1-2.

Medical electrical equipment is subject to special EMC preventive measures. It must be installed and operated as specified in the Installation Requirements document.

If high-voltage systems, radio link systems or MRI systems are located within 5 m of the unit, please observe the specifications stated in the installation requirements.

Portable and mobile RF communications equipment may interfere with medical electrical equipment. Therefore, the use of mobile wireless phones in medical offices or hospital environments must be prohibited.

For more details, refer to the document Electromagnetic Compatibility Information.

Please also observe the ESD (ESD: Electro-Static Discharge) protective measures described below.

Static Discharge

❚

● Connector pins or sockets bearing ESD warning labels must not be touched or interconnected without observing ESD protective measures.

Electrostatic discharge (ESD)

PaX-i3D Smart

10 I

2. Warnings and Precautions

ESD protective measures include

❚

● Procedures for preventing electrostatic charge build-up (e.g. air conditioning, air moistening, conductive floor coverings and non-synthetic clothing)

● Discharge the electrostatic charges of your own body on the frame of the UNIT, the protective ground wire or large metallic objects.

● Use the wrist band for grounding.

2.3

Radiation Safety

English

Since rules and regulations concerning radiation safety differ between countries, it is the responsibility of the owner and/or operator of this equipment to comply with all applicable rules and regulations concerning radiation safety and protection in their area.

● The operator must remain outside a shielded room during X-ray exposure in order to protect himself/herself from radiation.

● The patient must wear a lead apron with neck and thyroid protection during X-ray exposure.

● Children and pregnant women must consult with a doctor before X-ray exposure.

● This equipment must be housed inside an X-ray shielded room.

● During imaging; the operator must maintain visual contact with the patient from outside the shielded area.

● The operator should continuously check the status of the patient and the equipment during imaging.

PaX-i3D Smart

11 I

2. Warnings and Precautions

● The operator must immediately stop imaging if the equipment malfunctions.

● The operator should be at least 2 m (6 feet) away from the equipment during imaging.

As a manufacturer of radiology equipment that conforms to stringent protection standards around the world, we guarantee the maximum degree of protection against radiation hazards for our equipment.

2.4

Warnings

The following warning statements should be obeyed with the utmost care. Failure to follow these warnings may cause severe damage to the equipment or physical injuries to the patient and/or operator.

X-ray equipment is hazardous to patient and the operator if proper exposure safety measures and/or operating instructions are not observed.

It is important to read this user manual carefully and strictly abide by all warnings and cautions stated within it.

● 3D image should not be used for screening examinations. Each exam must be justified by demonstrating that the benefits outweigh the risk.

● Where it is likely that evaluation of soft tissues will be required as part of the patient’s radiological assessment, conventional medical CT or MR should be used instead of dental cone beam imaging.

PaX-i3D Smart

12 I

2. Warnings and Precautions

● PaX-i3D Smart system, like other medical equipment, uses high-frequency electrical signals that can interfere with implantable devices such as pacemakers and implantable cardioverter-defibrillators(ICDs). If the patient has such an implantable device, you should be aware of any interference in its operation and immediately power off the Dental X-ray system.

● PaX-i3D Smart system is designed to withstand the effects of defibrillation. However, when possible, disconnect the Dental X-ray systems during defibrillation since a malfunction of the safety controls could otherwise result in electrical burns for the patient.

Federal law restricts this device to sale by or on the order of dentist or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device.

Lasers

❚

English

● The system incorporates Class 1 laser products. The light localizers used in this product are intended for correct patient positioning and must not be used for any other purpose.

● For maximum safety, advise the patient not to look directly at the laser beam.

● While adjusting the patient, ensure that the laser beam is not directed at the patient’s eyes.

Risk of eye injury!

Do not use this equipment with any other laser sources and do not make any changes to the settings or processes that are described in these operating instructions.

PaX-i3D Smart

13 I

2. Warnings and Precautions

Cleaning

❚

● Never expose this equipment to liquids, mists or sprays. Exposing this equipment to liquids may cause an electrical shock or otherwise damage the system.

● Do not use spray cleaners on this equipment, as this could cause a fire.

During Operation

❚

● Never use this equipment in an environment that is susceptible to explosion.

● Do not place flammable materials near this equipment.

● Do not operate the PC while the equipment is performing an operation. Failure to comply with this instruction may result in system malfunction.

● Immediately stop imaging if the equipment malfunctions in any way.

● If a problem occurs during imaging, press the red emergency stop button to immediately stop all moving parts and cut off all power to the equipment’s electrical components.

● Never touch the patient while also touching the SIP/SOP connectors.

● The medical electrical equipment or medical electrical system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the medical electrical equipment or medical electrical system should be observed to verify normal operation in the configuration in which it will be used.

● The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the VATECH of the medical electrical equipment or medical electrical system as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of EQUIPMENT or SYSTEM.

In case of electrical fire

❚

● Use only fire extinguishers designed for electrical fires to extinguish fires on this equipment.

Liquid extinguishers, such as those which use water, could damage the equipment and/or cause injury.

● Unplug the equipment’s power cable before extinguishing any fire.

PaX-i3D Smart

14 I

2. Warnings and Precautions

Installation

❚

● In order to avoid improperly balanced equipment, install the device on a flat surface to maintain stability.

● If the equipment is not stable, property damage and/or personal injury may occur.

● Do not push or pull the equipment.

● Equipment should only be installed by an authorized technician, complying with proper installation procedures.

Security Capabilities

❚

● It is recommended to install and operate EasyDent/EzDent-i SW within secure operating environment that allows only authorized users to access and the system network is equipped with Window firewall built-in Windows system, windows Defender antispyware tools and other commonly used 3rd party security tools and application systems.

● The latest updates for anti-virus software and a firewall is recommended.

● The software can be updated by the manufacturer only. Unauthorized software update through a third party, not the manufacturer, is strictly prohibited. For cyber security issues related to the software and medical devices, please contact the manufacturer.

English

PaX-i3D Smart

15 I

Imaging System

Overview

3.1 Introduction ...........................18

3.2 Imaging System Configuration ..

..............................................21

3.3 Equipment Overview .............23

3. Imaging System Overview

3.1

Introduction

PaX-i3D Smart is an advanced digital dental diagnostic system that incorporates

Panoramic (PANO), Cephalometric (CEPH), and CBCT imaging capabilities into a single system.

3.1.1

Intended Use

PaX-i3D Smart(PHT-30LFO) is a computed tomography x-ray system intended to

produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.

3.1.2

System Components

3.1.3

● PaX-i3D Smart digital x-ray equipment

● PC system

● Imagaing Software

● EasyDent / EzDent-i: 2D viewer and patient management software

● Ez3D plus / Ez3D-i: 3D viewer and image analysis software

Features

● Low dose Imaging

● 3D Pan and Real 2D image acquisition by single scan

● 3D Viewer: 3D imaging supports precision analysis and diagnosis

● Supports the international digital imaging standard DICOM

PaX-i3D Smart

18 I

3. Imaging System Overview

3.1.3

PaX-i3D Smart Options

Model Item Sensor

PANO+CBCT PANO/CT Xmaru1404CF

PANO+CBCT +CEPH

3.1.5

Standards and Regulations

Standards

❚

PaX-i3D Smart was designed and developed to comply with the following international standards and regulations.

PANO/CT Xmaru1404CF

CEPH Xmaru2301CF

PANO/CT Xmaru1404CF

CEPH 910SGA

PANO/CT Xmaru1404CF

CEPH 1210SGA

English

IEC/EN 60601-1(3rd), UL 60601-1(1st), IEC/EN 60601-1-3, IEC 60601-2-63

21 CFR 1020.30, 31, 33

NEMA Standard publication PS 3.1-3.18, 2008

This is Class11b equipment and received the CE mark for regulations compliance in accordance with the revised Medical Devices Directive 93/42 EEC.

This equipment received the UL certification mark in accordance with UL 60601-1/CAN/CSA C22.2 No.601.1 regulations.

PaX-i3D Smart

19 I

3. Imaging System Overview

Classification (IEC60601-1 6.1)

❚

● Degree of protection against the ingress of water: Ordinary Equipment: IPX0

● Degree of protection against electric shock: Class 1 equipment, Type B Applied Parts

PaX-i3D Smart

20 I

3. Imaging System Overview

3.2

Imaging System Configuration

PaX-i3D Smart

Exposure switch

SIGNAL INPUT

WARNING SYSTEM BOX

LAMP INPUT LAMP OUTPUT

Warning system panel

Warning lamp

(Optional)

Door interlock

Fiber Optice Cable 10m(32.8'): SCAN CEPH(Optional)

iber

Ethernet Cable(CAT5e): OneShot CEPH(Optional)

thern

iber

Fiber Optic Cable 10m(32.8'): PANO, CT

PC w/ imaging and

image viewer programs

English

PaX-i3D Smart

21 I

3. Imaging System Overview

PC Signal Input / Output

❚









No. Parts

1 3D Viewer License Key

2 Video out

3 Fiber optic cable in / out x 2 (PANO/CT, CEPH)

4 Ethernet cable(CAT5e) for OneShot CEPH(optional)

PaX-i3D Smart

22 I

3. Imaging System Overview

3.3

-



Equipment Overview

Scan CEPH

 



Oneshot CEPH



English













-

 



PaX-i3D Smart

23 I



3. Imaging System Overview

No. Name Function

CEPH imaging sensor (optional)

X-ray Sensor

(CEPH)

2 Nasal Positioner

3 Ear Rod Secure the patient’s head during CEPH imaging.

− 1-1. One shot Type

− 1-2. Scan Type

− Positions the patient during CEPH imaging.

− The ruler for use to compensate the acquired image that is different from actual size.

Secondary

Collimator

5 Vertical Frame

6 Rotating Unit

Enclosed

Component Storage

8 X-ray Tube The vacuum tube where the x-ray is produced.

9 Emergency Switch

Vertical Frame

Up/Down Switch (optional)

11 Base (optional) Balances the equipment and maintains its safety.

Limits the X-ray irradiation field for CEPH scanning.

Holds the Rotating Unit.

Use the Vertical Frame Up/Down switch.

Rotates around the patient's head as image is being acquired.

Movement depends on the scan mode.

Place where bite blocks, integrated chin rests and the other components are stored.

Powers off the equipment when there is a problem during operation.

Adjusts the height of the vertical frame.

12 Stationary Column A fixed column.

Operates the horizontal beam, opens/closes temple

13 Control Panel

supports, and adjusts the height of the vertical frame and prepares for operation when the Ready button is pressed.

PaX-i3D Smart

24 I

3. Imaging System Overview

No. Name Function

14 Chin Rest A place to rest the chin.

15 Temple Supports Patient head support: Use in PANO and CBCT modes.

English

X-ray Sensor

(PANO/CT)

17 LED Lamp

PANO / CBCT Sensor

Indicates the emission status while the x-ray is in operation.

- Green: Ready

- Orange: X-ray ON

PaX-i3D Smart

25 I

3. Imaging System Overview

3.3.1

Control Panel

   

No. Button Description

Vertical Frame Up/

Down button

Horizontal Beam

Control button

Temple Support

OPEN/CLOSE button

READY/ RETURN

button

Adjusts the vertical frame by moving vertically.

Positions the horizontal beam in PANO mode.

Adjusts the temple supports to position the patient.

When pressed, prepares for operation after positioning the patient and configuring the environment settings.

Initializes the positioning of the rotating unit.

PaX-i3D Smart

26 I

3. Imaging System Overview

3.3.2

Emergency Stop Switch

During operation, the following emergency situations may occur:

● X-ray emission continues after the exposure switch has been released

● Injury to the patient or damage to the equipment

● Other emergency situations

If a problem occurs during image acquisition, press the red Emergency Stop Switch to immediately stop the moving parts and cut off all power to the equipment’s electrical components. To reset the Emergency Stop Switch, turn it clockwise until it pops up.

English

PaX-i3D Smart

27 I

3. Imaging System Overview

3.3.3

Exposure Switch

The exposure switch allows the operator to control image acquisition from outside of the X-ray room.

Press and hold the exposure switch down until acquisition is complete. Premature release of the exposure switch will abort image acquisition.

Pressing the exposure switch activates the orange indicator light to indicate that the X-ray is being emitted.

Exposure Switch

X-ray Exposure LED

● Green: Standby (X-ray Off)

● Orange: Run (X-Ray On)

The exposure switch is detachable. Ensure the exposure switch cable is not pulled out from the unit accidentally during operation.

PaX-i3D Smart

28 I

3. Imaging System Overview

3.3.4

Enclosed Component

The enclosed components can be disassembled and cleaned. All enclosed components that are used to support the patient(bite block, chin rest and temple supports) should be cleaned with ethanol and wiped with clean towels.

Components Name and Function

Bite Block

Temple Supports (1 set)

Integrated Chin Rest: TMJ, Sinus

Ear Rod (1 set)

English

Panorama Cover

300 pcs

Nasal Positioner Cover (for CEPH)

Carpus Plate

Integrated Chin Rest Sanitary Vinyl Covers (disposable): Bite Block

Protractor (1 set): Use to position the body in CEPH mode.

PaX-i3D Smart

29 I

Imaging Software

Overview

4.1 PC Specifications ..................32

4.2 EasyDent / EzDent-i .............34

4.3 Console Software ..................35

4. Imaging Software Overview

Three programs come with this equipment to acquire, process, and view the image:

● EasyDent / EzDent-i: 2D viewer, analysis, and patient management

● Ez3D plus / Ez3D-i: 3D Viewer and analysis

● Console software: PANO / CEPH / CBCT

4.1

PC Specifications

● The PC system plays an important role in image processing and verification. Configure the PC environment to meet the following specifications. If the PC specifications are not met, the image quality may be low.

● Do not place patients near the equipment and PC.

Item HP LENOVO

CPU

RAM 16GB DDR3-1600 ECC RAM 16GB DDR3-1600 ECC RAM

Hard disk drive 1TB SATA 1st HDD 1TB SATA 1st HDD

Graphics board

Ethernet interface

Serial Port (RS232) HP Serial Port Adapter Kit 1 (On Board)

Power supply ≥ 600 Watts (90 % Efficiency) ≥ 610 Watts (85 % efficient)

Slots

Intel Xeon E5-1607 3GHz 1600 4C or Faster

NVIDIA Geforce GTX970 D5 4GB or greater

Broadcom 5761 Gigabit Ethernet

2 PCI Express Gen3 x 16 slots 1 PCI Express Gen3 x 8 slot 1 PCI Express Gen2 x 8 slot 1 PCI Express Gen2 x 4 slot 1 PCI slot

Intel Xeon E5-1607 3GHz 1066 or Faster

NVIDIA Geforce GTX970 D5 4GB or greater

Intel 82579 Gigabit Ethernet

2 PCI Express Gen3 x 16 slot 1 PCI Express Gen3 x 16 slot

(x4 Electrical) 1 PCI Express Gen2 x 4 slot 1 PCI slot

PaX-i3D Smart

32 I

4. Imaging Software Overview

Item HP LENOVO

English

CD/DVD drive

Monitor

Operating system

Recommended system

DVD-ROM, DVD+/-RW, BluRay

19” 1280 x 1024 screen resolution

Windows 7 Professional 64-Bit

Z420 S30

DVD-ROM DVD R/W, Blu-Ray R/W

19” 1280 x 1024 screen resolution

Windows 7 Professional 64-Bit

PaX-i3D Smart

33 I

4. Imaging Software Overview

4.2

EasyDent / EzDent-i

EasyDent / EzDent-i is dental imaging software from Vatech Co. Ltd that manages

patient images so you can make faster, more accurate diagnoses. The console software and 3D Viewer are linked with EasyDent / EzDent-i making it convenient for the user to use and process necessary images. Various functions can be used so that acquired images can be processed quickly and conveniently from the console software.

Please refer to 5.3 Creating New Patient and 5.4 Retrieving Patient Information and EasyDent / EzDent-i User manual for more information.

Security Capabilities

● The latest updates for anti-virus software and a firewall is recommended.

PaX-i3D Smart

34 I

4. Imaging Software Overview

4.3

Console Software

Use the console software to configure the imaging environment according to the mode.

● To improve program functions, the console software may change without notice.

The main screen of the Console Software consists of the following. Each one of the different modes will be described later.

  





English

 





 



PaX-i3D Smart

35 I







4. Imaging Software Overview

No. Function Description

1 Imaging Mode Display

This displays the current imaging mode.

● Indicates that the Magic PAN is supported in the PANO imaging modality.

● Is displayed only for the Standard mode, with the Magic PAN enabled.

Scanning Status and

Image Preview Window

3 Patient Information

4 Imaging Guide Window

Scan Time and DAP

Display Window

Tube Voltage and

Current Adjustment

This shows image acquisition progression in realtime.

This displays information about the selected patient.

This displays various text instructions for the operator to follow.

Upon clicking CONFIRM, the scan time and estimated DAP value is displayed in this window.

If the patient is selected in EasyDent / EzDent-i, the default kVp/mA according to the patient’s information (gender/age) is displayed. This tool adjusts the kVp and mA values or control the power of the X-ray in order to improve image quality. If necessary, adjust the kVp and mA values manually using the arrows.

For the tube voltage and its correspondence with the current patient, refer to Appendix >

13.1 Recommended X-ray Exposure Table.

PaX-i3D Smart

36 I

4. Imaging Software Overview

No. Function Description

English

This displays the current patient’s gender as entered in EasyDent / EzDent-i’s patient information. If necessary, gender can be manually selected.

7 Patient Gender

8 X-ray intensity

Age Group / Gender VATECH’s Standard

Child ≤12

Man

Adult

Woman

This tool selects X-ray intensity.

Depending on the circumference of the patient’s head, X-ray intensity may be classified as Hard, Normal, or Soft :

Soft ≤ Normal ≤ Hard

Age

Average head

Group

circumference

Child 53±3 cm

Adult 56±3 cm

Range

(cm)

> 53±3 Hard

53±3 Normal

53±3 < Soft

> 56±3 Hard

56±3 Normal

56±3 < Soft

≥13

Classification

of head

circumference

PaX-i3D Smart

37 I

4. Imaging Software Overview

No. Function Description

Phantom Capture

This function is used when the Phantom Jig is being used to acquire images.

Image acquisition using the Phantom Jig:

1. Click Phantom Capture Icon.

2. Select the Modality, followed by OK.

3. Check the parameters displayed in the main GUI window. If correct, click the ‘Confirm’ button.

4. Align the Phantom Jig, and click the ‘Ready’ button.

5. Press and hold down the exposure switch.

Manual Image

Reconstruction

Laser Beam On / Off

Button

Settings

Exit

14 Imaging Mode

If automatic reconstruction of the image fails, use this function to reconstruct the image manually. Select Modality and click Search Reconstruction.

Use this icon to turn the laser beam on or off for patient positioning. This button is enabled when the CONFIRM button is clicked after the imaging environmental parameters are configured.

This Control Panel displays and sets various equipment-related parameters, including language, automatic save, DAP display unit, etc.

This button exits the capturing program.

This selects an imaging mode – PANO, CEPH or CBCT.

PaX-i3D Smart

38 I

4. Imaging Software Overview

No. Function Description

English

After confirming all settings required for scanning, press CONFIRM to apply the settings.

15 CONFIRM

16 READY

When you click CONFIRM, the scan time and estimated DAP (Dose Area Product) value will be shown on the main display for the exposure you are going to take.

This button is used when all aspects of preparation have done for image acquisition (including parameter settings and patient positioning)

PaX-i3D Smart

39 I

Getting Started

5.1 Turning On Equipment ..........42

5.2 Running the Image Viewer ....44

5.3 Initiating the Console Software .

..............................................50

5. Getting Started

5.1

Turning On Equipment

● Do not place the patient close to the equipment is on. Doing so may cause injury to the body and damage to equipment.

● Do not turn on the PC while the equipment is in operation. Doing so may cause an error.

● Excessive temperature changes may cause condensation to form on the equipment. When room temperature is reached, turn on the equipment.

● Equipment rebooting: After turning it off, the equipment may be turned on again after 20 seconds.

● Warm-up the equipment for at least 5 minutes before the operation. For the best image quality, it is recommended that equipment be warmed-up for 30 minutes or more.

If the equipment has not been used for a long time, please leave enough time to warm-up the equipment. It extends the life of the x-ray tube.

The imaging system mainly consists of the imaging equipment and the PC.

Before turning on the equipment, please confirm the equipment and PC correctly installed.

PaX-i3D Smart

42 I

5. Getting Started

1. Turn on the PC.

2. Press the switch that is located under the handle frame to turn on the equipment.

OFF (O) ON ( I )

ON ( I )

3. Confirm the green LED light at the top of the equipment is on.

4. Plug the license key for the 3D viewer into the PC.

English

PaX-i3D Smart

43 I

License Key

5. Getting Started

5.2

Running the Image Viewer

EasyDent / EzDent-i is a basic imaging platform for all VATECH’s dental X-ray equipments. The Imaging Program is interfaced with EasyDent / EzDent-i. On your desktop, double-click EasyDent / EzDent-i icon. The EasyDent / EzDent-i main window will be displayed.

For further details on this subject, refer to the EasyDent / EzDent-i user manual.

Security Capabilities

● The latest updates for anti-virus software and a firewall is recommended.

For PHT-30LFO dental computed tomography X-ray system, both 3D Viewer(Ez3D plus/Ez3D-i) and console software are being accessed through 2D Viewer(EasyDent/EzDent-i) SW. 3D Viewer and console software do not have image storage capability of its own and both programs will not be able to patient information.

PaX-i3D Smart

44 I

5. Getting Started

5.2.1

Creating a New Patient Record

To create a new patient record, follow the procedure outline below:

EasyDent

❚

A. Click the Patient icon on the upper left corner of the EasyDent’s main GUI window.

English

PaX-i3D Smart

45 I

5. Getting Started

B. The following dialog box will open.

C. Enter the required patient information. Chart Number, First Name, and Last Name are required fields which must be filled in. All other fields are optional, but it is recommended that they be filled in.

D. Click Add to save the patient record.

EzDent-i

❚

A. Click the Add Patient icon from main GUI window.

B. Enter the required patient information. The Chart Number, E-Mail address, First Name, and Last Name are required fields which must be filled in. (The chart number fills in automatically.)

C. Click Add to save the patient record.

PaX-i3D Smart

46 I

5. Getting Started

Limit Access to Trusted Users Only

English

● EzDent software requires each operator to set up a unique user ID and password to prevent any unauthorized access to patients’ confidential information.

● User ID and password can be assigned to give permission to register, add, delete and modify patient information and diagnostic images. The application of User ID and password authentication assures the accountability that the prescribed access process is being done by an authorized user.

● According each operator’s privilege level, the login enables the user to search, register, modify and delete the patient information or diagnostic images. Different search criteria suggest availability of the patient information being sought.

− Search by ID: Search by ID is possible if the patient id is known.

− Search by Name: Search by the name of the patient is possible.

− Search by age and gender can be used to divide the search result further, for patients with the same name.

● The user’s Login/Logout time and work duration can be traced via log data.

PaX-i3D Smart

47 I

5. Getting Started

5.2.2

Retrieving Patient Records

EasyDent

❚

You can search through the patient database using a patient’s chart number, their first name, or their last name.

A. On the Patient information pane, double-click the Chart No., First name, or Last name of the patient and the virtual keyboard will pop up.

Double-click

B. Enter the Chart No., First name, or Last name of the patient by clicking the mouse on the virtual key board and click the Enter (The physical keyboard can be used to do the same job).

C. Patient information can be displayed on the Patient information pane and Patient List.

PaX-i3D Smart

48 I

5. Getting Started

EzDent-i

❚

A. Enter the name or chart number of the patient to be searched on the Search pane and then click the Search button. The information on the patient that fits the search condition appears.

Enter

Double-click the Keyboard icon to display the virtual keyboard. You may search patient information using the virtual keyboard.

English

B. Double-click the patient information to see more details about the patient as shown below.

Double-click

PaX-i3D Smart

49 I

5. Getting Started

5.3

Initiating the Console Software

For a new patient, first register the patient information.

EasyDent

❚

A. First, click the patient information in the patient list, and click the Dental CT icon (

) in the upper left corner of the EasyDent’s main window to open the imaging

program.

B. The following imaging program window opens. The sole purpose of this window is to control equipment settings and acquire images.

PaX-i3D Smart

50 I

5. Getting Started

EzDent-i

❚

A. Search and select the patient to be captured.

B. Click Acquisition and the imaging mode (CT, Panorama, or Cephalo).

C. The main screen for the selected mode appears. (See 4.3 Imaging Software Overview). From the main screen, you can configure the imaging parameter settings prior to acquiring an image.

English

Please proceed to the next chapter.

Refer to chapters 6 - 8 for information regarding image acquisition.

51 I

PaX-i3D Smart

Acquiring PANO images

6.1 Setting Exposure Parameters ..

..............................................59

6.2 Patient Positioning ................63

6.3 X-ray Exposure ......................77

6.4 Finishing Scan .......................78

6.5 Confirming Image ..................78

6. Acquiring PANO images

To acquire PANO Images, first 5. Getting Started must be completed. If

5. Getting Started is not completed, you must go back to the 5. Getting Started and

finish the step first.

PANO Examination Program

Examination Arch Selection Examination Program

Standard

Right

Front

PANO

EXAMINATION

SPECIAL

EXAMINATION

Narrow, Normal,

Wide, Child ,

Orthogonal

Left

Bitewing*

Bitewing Incisor*

Bitewing Right*

Bitewing Left*

TMJ LAT Open

TMJ LAT Close

TMJ PA Open

TMJ PA Close

Sinus LAT

Sinus PA

* Bitewing examinations are available only when Orthogonal Arch is selected.

PaX-i3D Smart

54 I

6. Acquiring PANO images

Arch Selection

Examination Program Image

Narrow (Standard): Panoramic image of V-shaped palatal arches (small number of adult females)

Normal (Standard): Panoramic image of normal adult palatal arches

English

Wide (Standard): Panoramic image of square-shaped palatal arches (some number of adult males)

PaX-i3D Smart

55 I

6. Acquiring PANO images

Examination Program Image

Child (Standard): Panoramic image of child palatal arches, 40% less x-ray dose than in Normal mode.

Bitewing: Imaging from targeted areas of palatal arches; less x-ray dose than in Standard mode.

PaX-i3D Smart

56 I

6. Acquiring PANO images

SPECIAL EXAMINATION

Examination Program Image

Orthogonal (Standard): Panoramic image where the x-ray angle enters vertically in between the teeth so overlapping images are minimized.

TMJ LAT Open / Close: The acquired image focused on the lateral TMJ area.

English

TMJ PA Open / Close: The acquired image focused on the posterior-anterior TMJ area.

PaX-i3D Smart

57 I

6. Acquiring PANO images

Examination Program Image

Sinus LAT: The acquired image focused on the lateral Maxillary Sinus area.

Sinus PA: The acquired image focused on the posterior-anterior Maxillary Sinus area.



PaX-i3D Smart

58 I

6. Acquiring PANO images

6.1

Setting Exposure Parameters

Perform the following procedures to select the capture parameters for the specific patient and capture mode. Please refer to 4.3 Console Software for more information.













English



Without Magic PAN With Magic PAN

1. Click the PANO button.

2. Select a PANO option.

Mode Description

Normal This is the normal type.

Reconstruct an image with optimized focus (autofocus) from the

Magic PAN

(Optional)

entire panorama to acquire high quality images so any errors caused by issues with the patient's position and tooth trajectory will be minimized.

PaX-i3D Smart

59 I



6. Acquiring PANO images

3. (Optional) Select an Image option.

Mode Description

HD High Definition, High Resolution

Low Dose Normal Image

You can select an image option only when you have purchased Magic PAN option. Default image option is HD.

4. Select Arch Selection.

Arch Selection Description

Narrow

Panoramic image of V-shaped palatal arches (small number of adult females)

Normal Panoramic image of normal adult palatal arches

Wide

Child

Panoramic image of square-shaped palatal arches (some number of adult males)

Panoramic image of child palatal arches, 40% less x-ray dose than in Normal mode.

Panoramic image where the x-ray angle enters vertically in between the teeth so overlapping images are minimized.

Orthogonal

5. Select an Examination Program.

If Orthogonal Arch is selected, four bitewing examinations(bitewing, bitewing incisor, bitewing right, bitewing left) are activated

PaX-i3D Smart

60 I

6. Acquiring PANO images

English



6. The gender of the patient is selected automatically. When necessary, it can be selected manually.

7. Select x-ray intensity.

Depending on the circumference of the patient’s head, X-ray intensity may be classified as Hard, Normal, or Soft :

Soft ≤ Normal ≤ Hard

Age

Group

Child 53±3 cm

Adult 56±3 cm

Average head

circumference



Range (cm)

> 53±3 Hard

53±3 Normal

53±3 < Soft

> 56±3 Hard

56±3 Normal

56±3 < Soft

Classification of head



circumference

8. The values of tube voltage and current are configured automatically according to the patient's gender and x-ray intensity. Click the arrow button to zoom in. The dose is adjustable by ±1 kVp and ±0.1 mA respectively.

9. Once the configuration has been completed, click the CONFIRM button.

PaX-i3D Smart

61 I

6. Acquiring PANO images

When you click CONFIRM button:

● The READY button will begin blinking to show that it has been activated.

● The Rotating unit will move to its initial scanning position.

● Three laser beams will be activated to make patient positioning easier.

● The Scan Time and DAP values will be shown on the Imaging Status Window.

10. Guide the patient to the equipment.

PaX-i3D Smart

62 I

6. Acquiring PANO images

6.2

Patient Positioning

English

● Have patients, especially pregnant women and children, wear a lead apron to protect them from residual radiation.

● Be careful not to direct the laser beam into the patient's eyes. Doing so can result in a permanent loss of vision.

● Correct posture reduces the shadow cast by the patient's cervical spine and allows for clear image acquisition.

● Metal implants or bridges may reduce the quality of the images.

● If the laser beam is not correctly positioned, distortion, where the image may be enlarged or reduced, or ghost shadows may occur and lower the image quality so please be careful.

In general, images are acquired when the patient is standing. In special cases, a chair without a backrest (stool) may be used. Do not obstruct the laser beam or the operation of the equipment with the chair.

Getting prepared

1. Ask the patient to remove all the metal objects (glasses, earrings, hair pins, braces,

false teeth). Metal objects may induce ghost images and lower the image quality.

2. Ask the patient to wear a lead apron to protect them from residual radiation.

3. Use the Vertical Frame Up/Down button or switch option to adjust the equipment

to match the height of the patient.

PaX-i3D Smart

63 I

6. Acquiring PANO images

6.2.1

Pano Standard Mode

Patient Positioning

1. Insert the bite block into the chin rest then cover with a sanitary vinyl cover.

Sanitary Vinyl Cover

Bite Block

Bite Block Lock/Unlock Knob

The sanitary vinyl cover is for single use only. It should be replaced after each patient. Be sure to use the approved vinyl cover.

Clean the chin rest and bite block with ethanol and wipe with a dry towel before the next patient.

2. Use the Temple Support Open/Close button on the control panel to widen the temple supports.

3. Guide the patient to the inside of the equipment.

4. Use the Vertical Frame Up/Down button or switch option to adjust the height of

the equipment so the patient's chin reaches the chin rest.

PaX-i3D Smart

64 I

6. Acquiring PANO images

5. Guide the patient to stand in the center of the equipment and direct them to remain in the position outlined below.

● Two hands: Hold the handles of the equipment tightly.

● Chest: Press against the equipment.

● Two feet: Keep both feet close to the inside of the base.

● Shoulders: Keep your shoulders relaxed and balanced.

● Cervical Spine: Straighten your body and stand still.

6. Direct the patient to correctly bite into the bite block groove with their front teeth.

7. Turn the knob to fix the bite block in place.

8. Direct the patient to maintain the posture as described below.

● Mouth: Close your mouth.

● Tongue: Touch the roof of your mouth.

● Two eyes: Close your eyes.

Mid-sagittal plane

laser beam

Frankfurt plane laser

beam

Canine laser beam

English

Edentulous Patient Positioning

1. Remove the bite block from the chin rest.

2. Use the Temple Support Open/Close button on the control panel to widen the

temple supports.

PaX-i3D Smart

65 I

6. Acquiring PANO images

3. Guide the patient to the inside of the equipment.

4. Use the Vertical Frame Up/Down button or switch option to adjust the height of the

equipment so the patient's chin reaches the chin rest.

5. Guide the patient to stand in the center of the equipment and direct them to remain in the position outlined below.

● Two hands: Hold the handles of the equipment tightly.

● Chest: Press against the equipment.

● Two feet: Keep both feet close to the inside of the base.

● Shoulders: Keep your shoulders relaxed and balanced.

● Cervical Spine: Straighten your body and stand still.

6. Direct the patient to maintain the posture as described below.

● Mouth: Close your mouth.

● Tongue: Touch the roof of your mouth.

● Two eyes: Close your eyes.

PaX-i3D Smart

66 I

6. Acquiring PANO images

Correct posture reduces the shadow cast by the patient's cervical spine and allows for clear image acquisition.

During image acquisition, direct the patient to maintain the posture as described below.

● Two hands: Hold the handles of the equipment tightly.

● Chest: Press against the equipment.

● Two feet: Keep both feet close to the inside of the base.

● Shoulders: Keep your shoulders relaxed and balanced.

● Cervical Spine: Straighten your body and stand still.

● Mouth: Bite the bite block and close your mouth.

● Tongue: Touch the roof of your mouth.

● Two eyes: Close your eyes.

Ask the patient to maintain their position and to not move until the image acquisition is completed.

English

Laser Beam Positioning

Be careful not to shine the laser beam directly into the person's eyes.

Doing so may result in vision loss.

If the laser beam is not correctly positioned, distortion, where the image may be enlarged or reduced, or ghost shadows may occur and lower the image quality. Be sure to align the laser beam properly.

1. Align the vertical beam with the center of the face. (To prevent horizontal expansion of the image)

PaX-i3D Smart

67 I

6. Acquiring PANO images

2. Align the horizontal beam in a straight line with the Frankfurt line on the patient's face. Use the Horizontal Beam button on the control panel to position it. Check to see that the horizontal beam aligns with the patient's face horizontally.

Mid-sagittal plane

laser beam

Frankfurt plane laser

beam

Canine laser beam

Frankfurt plane laser

beam UP button

Frankfurt plane laser

beam DOWN button

3. Direct the patient to smile and align the canine teeth beam with the center of the canines. Use the Canine Teeth Beam level to adjust the position of the beam.

Canine laser

Canine

Teeth Beam

beam lever

Finishing Patient Positioning

1. After checking the positions of the patient and the laser beam, click the Temple Support Open/Close button on the control panel to prevent the patient's head

from moving.

2. Click the READY button. The x-ray exposure has not started yet.

3. Now go to 6.3 X-ray Exposure to begin operation.

PaX-i3D Smart

68 I

6. Acquiring PANO images

6.2.2

TMJ Open Mode

Acquire the TMJ Close image after the TMJ Open image has been acquired.

Steps for TMJ Mode

TMJ Open positioning > Align Laser Beam > X-ray Exposure > TMJ Close positioning > Align Laser Beam > X-ray Exposure

Clean the chin rest and bite block with ethanol and wipe with a dry towel before the next patient.

TMJ Open Positioning

1. Insert the integrated chin rest into the equipment.

English

Chin support

Lock / release knob for

bite block

Clean the chin rest with ethanol and wipe with a dry towel before the next patient.

2. Use Temple Support Open/Close button on the control panel to widen temple supports.

3. Guide the patient to the inside of the equipment.

PaX-i3D Smart

69 I

6. Acquiring PANO images

4. Use the Vertical Frame Up/Down button or switch option to adjust the height of the equipment so the patient's chin reaches the chin rest.

5. Guide the patient to stand in the center of the equipment and direct them to remain in the position outlined below.

● Two hands: Hold the handles of the equipment tightly.

● Chest: Press against the equipment.

● Two feet: Keep both feet close to the inside of the base.

● Shoulders: Keep your shoulders relaxed and balanced.

● Cervical Spine: Straighten your body and stand still.

6. Lower the integrated chin rest to the bottom and turn the knob to fix it.

7. Guide the patient to press the base of their nose (acanthion point) against the chin

rest and tilt their head forward about -5˚. At this point, make sure the patient's jaw does not to touch the equipment.

If the jaw touches the equipment it is difficult to maintain the proper position to get good images.

Be careful the patient does not to touch the equipment with their jaw.

8. Direct the patient to maintain the posture as described below.

● Mouth: After swallowing once, open your mouth as wide as possible.

● Tongue: Touch the roof of your mouth.

● Two eyes: Close your eyes.

● As shown in the picture, the support unit of the integrated chin rest should touch the patient's acanthion point.

● Ask the patient to maintain their position until the operation is completed.

PaX-i3D Smart

70 I

6. Acquiring PANO images

Laser Beam Positioning

Be careful not to shine the laser beam directly into the person's eyes.

Doing so may result in vision loss.

1. Align the vertical beam with the center of the face. (To prevent horizontal expansion of the image)

2. Align the horizontal beam in a straight line with the Frankfort line on the patient's face. Use the Horizontal Beam button on the control panel to position it. Check to see that the horizontal beam aligns with the patient's face horizontally.

3. Align the Canine Teeth Beam with the center of the patient's canines. Use the Canine Teeth Beam level to adjust the position of the beam.

English

Mid-sagittal plane

laser beam

Frankfurt plane laser

beam

Canine Teeth Beam

PaX-i3D Smart

71 I

Canine laser

beam lever

6. Acquiring PANO images

Finishing Patient Positioning

1. After checking the positions of the patient and the laser beam, click the Temple Support Open/Close button on the control panel to prevent the patient's head

from moving.

2. Click the READY button. The x-ray exposure has not started yet.

3. Now go to 6.3 X-ray Exposure to begin operation.

6.2.3

TMJ Close Mode

Acquire the TMJ Close image after the TMJ Open image has been acquired.

Steps for TMJ Mode

TMJ Open positioning > Align Laser Beam > X-ray Exposure > TMJ Close positioning > Align Laser Beam > X-ray Exposure

Correct posture reduces the shadow cast by the patient's cervical spine and allows for clear image acquisition.

TMJ Close Positioning

1. After TMJ Open image is acquired, a "Do you want to take the TMJ Close image

continuously?" message is displayed. Press the Confirm button to begin TMJ Close Mode.

2. Lower the integrated chin rest to the bottom and turn the knob to fix it.

3. Guide the patient to press the base of their nose (acanthion point) against the chin

rest and tilt their head forward about -5˚. At this point, make sure the patient's jaw does not to touch the equipment.

PaX-i3D Smart

72 I

6. Acquiring PANO images

If the jaw touches the equipment it is difficult to maintain the proper position to get good images.

Be careful the patient does not to touch the equipment with their jaw.

4. Direct the patient to maintain the posture as described below.

● Mouth: After swallowing once, open your mouth as wide as possible.

● Tongue: Touch the roof of your mouth.

● Two eyes: Close your eyes.

English

● As shown in the picture, the support unit of the integrated chin rest should touch the patient's acanthion point.

● Ask the patient to maintain their position until the operation is completed.

Laser Beam Positioning

This is the same as for TMJ Open mode.

Finishing Patient Positioning

This is the same as for TMJ Open mode.

PaX-i3D Smart

73 I

6. Acquiring PANO images

6.2.4

Sinus Mode

Patient Positioning

1. Insert the integrated chin rest into the equipment.

Clean the chin rest with ethanol and wipe with a dry towel before the next patient.

2. Use Temple Support Open/Close button on the control panel to widen temple supports.

3. Guide the patient to the inside of the equipment.

4. Use the Vertical Frame Up/Down button or switch option to adjust the height of

the equipment so the patient's chin reaches chin rest.

5. Guide the patient to stand in the center of the equipment and direct them to remain in the position outlined below.

● Two hands: Hold the handles of the equipment tightly.

● Chest: Press against the equipment.

● Two feet: Keep both feet close to the inside of the base.

● Shoulders: Keep your shoulders relaxed and balanced.

● Cervical Spine: Straighten your body and stand still.

6. After adjusting the integrated chin rest, turn the knob to fix the chin rest.

PaX-i3D Smart

74 I

6. Acquiring PANO images

7. Position the integrated chin rest so it rests directly under the patient's lower lip.

8. Direct the patient to maintain the posture as described below.

● Head: Tilt the head back 10˚ - 15˚.

● Mouth: Close your mouth.

● Tongue: Touch the roof of your mouth.

● Two eyes: Close your eyes.

Ask the patient to maintain their position until the operation is completed.

English

PaX-i3D Smart

75 I

6. Acquiring PANO images

Laser Beam Positioning

Be careful not to shine the laser beam directly into the person's eyes.

Doing so may result in vision loss.

1. Align the vertical beam with the center of the face. (To prevent horizontal expansion of the image)

2. Tilt the patient's head back 10˚ - 15˚ then align the horizontal beam with tip of the nose. Use the Horizontal Beam button on the control panel to position it.

3. Align the Canine Teeth Beam with the center of the patient's canines. Use the Canine Teeth Beam level to adjust the position of the beam.

Finishing Patient Positioning

1. After checking the positions of the patient and the laser beam, click the Temple Support Open/Close button on the control panel to prevent the patient's head

from moving.

2. Click the READY button. The x-ray exposure has not started yet.

3. Now go to 6.3 X-ray Exposure to begin operation.

PaX-i3D Smart

76 I

6. Acquiring PANO images

6.3

X-ray Exposure

After the aligning the laser beam, the x-ray scan can begin.

The user must comply with the laws of the country regarding the usage of the medical equipment.

Direct the patient to close their eyes during operation.

To acquire optimized images, direct the patient to hold their breath and to not swallow. Also, direct them to not move.

1. Direct the patient to close their eyes.

2. Close the door when leaving the x-ray room. Observe the patient during operation

and check the imaging status.

3. Begin acquisition by pressing the exposure switch. Continue to press the exposure switch until the image has been acquired.

English

Orange: X-ray On

4. Release the exposure switch when “Image capturing is completed” message appears on the screen.

PaX-i3D Smart

77 I

6. Acquiring PANO images

During x-ray exposure, the status appears as follows.

● The exposure switch LED light is orange.

● The exposure switch LED light on top of the equipment is orange.

● An alert will sound to indicate that x-ray emission is currently underway.

● In the console software, the x-ray On in yellow changes.

6.4

Finishing Scan

1. Open the temple supports and guide the patient out of the equipment.

2. Remove the hygiene cover from the bite block.

3. Press

6.5

Confirming Image

Acquired images can be reconstructed and converted to DICOM format.

The exported images can be confirmed in EasyDent / EzDent-i.

1. The images are transferred to EasyDent / EzDent-i automatically.

2. The images are automatically saved if automatic save is configured in the basic settings. If automatic save is not configured in the basic settings, click the Save to DB button to save the images.

3. Double-click the image to confirm in the Patient list.

(Return) button to bring the Rotating Unit back to its initial position.

Please refer to the EasyDent / EzDent-i User manual for more information.

PaX-i3D Smart

78 I

Acquiring CEPH images

7.1 Setting Exposure Parameters ...

..............................................82

7.2 Patient Positioning ................85

7.3 X-ray Exposure ......................95

7.4 Finishing Scan .......................96

7.5 Confirming Image ..................96

7. Acquiring CEPH images

To acquire images, 5. Getting Started should be completed first. If 5. Getting Started is not completed, return to that section and finish the step first.

CEPH Imaging Software

❚

Examination Image Description

● The radiation is directed from the posterior of the skull to the anterior.

● Use to examine cranial diseases, trauma and congenital malformations.

● Used to assess the growth of lateral side of the face. It is also useful to examine the ramus mandibulae, the posterior region of the third largest

molar in the lower jaw, and the side wall of the maxillary sinus, and the frontal sinus, antrum ethmoidale, olfactory pits and optic disc pits.

Lateral

● Measure the angles formed by the connecting lines between the cranial measurement points to further assess the growth of the facial region. It is widely used in Orthodontics and Oral and Maxillofacial Surgery.

● Study craniofacial disease, trauma and congenital malformation and examine the soft tissue in the otorhinolaryngological area, sinus and hard palate.

● Measure the angles formed by the connecting lines between the cranial measurement points to further assess the growth of the facial region. It's widely used in Orthodontics and Oral and Maxillofacial Surgery.

PaX-i3D Smart

80 I

7. Acquiring CEPH images

Examination Image Description

Use to study the base of the skull, horizontal angulation of the mandibular condylar axis, sphenoidal sinus,

SMV

Waters View

curvature of the lower jaw, side wall of the maxillary sinus, and zygomatic arch fractures. Also useful to study the inner and outer alar plates and holes at base of the skull.

Use to study the frontal sinus, antrum ethmoidale, optic disc pit, frontozygomatic suture, nasal cavity, coronoid process between the upper jaw and zygomatic arch.

English

CARPUS

81 I

Use to assess hand bone age and compare with changes in the skull.

PaX-i3D Smart

7. Acquiring CEPH images

7.1

Setting Exposure Parameters

Perform the following procedures to select the capture parameters for the specific patient and capture mode. Please refer to 4.3 Console Software for the more information.

Steps for Configuring Imaging Conditions

❚





ex) SC Sensor(Xmaru2301CF) ex) OP Sensor(1210SGA)

1. Click the CEPH button.

2. Select the examination program under Ceph Examination

3. (For One-shot CEPH only) Do the selections that follow.

— FOV Size: Select the FOV size.

FOV Details Model

Large

: 12x10 (inches) : 30.48x25.40 (cm)

Full size OP(1210SGA)



PaX-i3D Smart

82 I

7. Acquiring CEPH images

FOV Details Model

English

Medium

: 9x10 (inches) : 22.86x25.40 (cm)

Small

: 8x8 (inches) : 20.32x20.32 (cm)

— Exposure Time: Scan time can be adjusted by resolution of 0.1 sec in the range of

0.7 sec to 1.2 sec.

4. The gender of the patient is selected automatically. When necessary, it can be selected directly.

5. Select x-ray intensity.

Region of the no interest of the rear part of the head is eliminated to minimize the X-ray exposure area.

For Child OP(1210SGA)





OP(1210SGA) / OS(910SGA)

/ OS(910SGA)



Depending on the circumference of the patient’s head, X-ray intensity may be classified as Hard, Normal, or Soft :

Soft ≤ Normal ≤ Hard

Age

Group

Child 53±3 cm

Adult 56±3 cm

Average head

circumference

PaX-i3D Smart

83 I

Range (cm)

> 53±3 Hard

53±3 Normal

53±3 < Soft

> 56±3 Hard

56±3 Normal

56±3 < Soft

Classification of head

circumference

7. Acquiring CEPH images

6. The values of tube voltage and current are configured automatically according to the patient's gender and x-ray intensity. Click the arrow button to zoom in. The dose is adjustable by ±1 kVp and ±0.1 mA respectively.

7. Once the configuration has been completed, click the CONFIRM button.

When you click CONFIRM button:

● The READY button will begin blinking to show that it has been activated.

● The Scan Time and DAP values will be shown on the Imaging Status Window.

8. Guide the patient to the equipment.

PaX-i3D Smart

84 I

7. Acquiring CEPH images

7.2

Patient Positioning

English

● Have patients, especially pregnant women and children, wear a lead apron to protect them from residual radiation.

● Be careful not to direct the laser beam into the patient's eyes. Doing so can result in a permanent loss of vision.

● Metal implants or bridges may reduce the quality of the images.

● If the laser beam is not correctly positioned, distortion, where the image may be enlarged or reduced, or ghost shadows may occur and lower the image quality so please be careful.

● Ensure that the nasal positioner left unfolded, before adjusting the ear rods in the proper direction.

Correct positioning is an important factor in capturing the best possible image.

Although the illustrations and explanations on patient’s posture and device usage are based on the OS / OP models (one shot-type sensor), those for the SC (scan type) model should be the same.

PaX-i3D Smart

85 I

7. Acquiring CEPH images

Getting Prepared

❚

1. Ask the patient to remove all the metal objects (glasses, earrings, hair pins, braces, false teeth). Metal objects may induce ghost images and lower the image quality.

2. Ask the patient to wear a lead apron to protect them from residual radiation.

3. Use the Vertical Frame Up/Down button or switch option to adjust the equipment

to match the height of the patient.

7.2.1

Lateral / Full Lateral Mode

Full Lateral mode is available for SCAN CEPH model only.

1. Leave enough space between the ear rods.

Ear Rod

Use the Porion position reference indicator that appears in the acquired image to easily

Porion position reference indicator

2. Guide the patient to the CEPH unit.

3. Direct the patient to relax their neck and shoulders and stand upright.

confirm the location of Porion.

PaX-i3D Smart

86 I

7. Acquiring CEPH images

4. Use the Vertical Frame Up/Down button or switch option to adjust the height of the CEPH Unit to approximately match the height of the patient.

5. During operation, properly align the ear rods with the patient's ears so their head does not move.

After adjusting the height of the column, align the ear rods and nasal positioner with the patient.

English

6. Align horizontally so the patient's Frankfort line is parallel with the floor.

7. Direct the patient to swallow first before closing their mouth and to remain in their

current position until image acquisition is complete.

8. Click the READY button. The x-ray exposure has not started yet.

9. Now go to 7.3 X-ray Exposure to begin operation.

PaX-i3D Smart

87 I

7. Acquiring CEPH images

7.2.2

Frontal (PA) mode

1. Rotate the ear rods 90° clockwise from their initial position as shown in the figure

Nasal Positioner

Ear Rod

Porion position

reference indicator

2. Fold the nasal positioner up. The nasal positioner is not used in Frontal mode.

3. Guide the patient to the CEPH unit.

4. Ask the patient to stand upright facing the sensor. Make sure that the patient’s

Use the Porion position reference indicator that appears in the acquired image to easily confirm the location of Porion.

shoulders are level and that his/her neck is relaxed.

PaX-i3D Smart

88 I

7. Acquiring CEPH images

5. Use the Vertical Frame Up/Down button or switch option to adjust the height of the CEPH Unit to approximately match the height of the patient.

6. During operation, properly align the ear rods with the patient's ears so their head does not move.

After adjusting the height of the column, align the ear rods and nasal positioner with the patient.

7. Align horizontally so the patient's Frankfort line is parallel with the floor.

English

8. Direct the patient to swallow first before closing their mouth and to remain in their current position until image acquisition is complete.

9. Click the READY button. The x-ray exposure has not started yet.

10. Now go to 7.3 X-ray Exposure to begin operation.

PaX-i3D Smart

89 I

7. Acquiring CEPH images

7.2.3

SMV Mode

1. Rotate the ear rods 90° clockwise from their initial position as shown in the figure.

Nasal Positioner

Ear Rod

Porion position

reference indicator

2. Fold the nasal positioner up. The nasal positioner is not used in Frontal mode.

3. Guide the patient to the CEPH unit.

4. Guide the patient to face the X-ray tube and stand upright.

Use the Porion position reference indicator that appears in the acquired image to easily confirm the location of Porion.

PaX-i3D Smart

90 I

7. Acquiring CEPH images

5. Use the Vertical Frame Up/Down button or switch (option) to adjust the height of the CEPH Unit to match the height of the patient.

6. During operation, properly align the ear rods with the patient's ears so their head does not move.

After adjusting the height of the column, align the ear rods and nasal positioner with the patient.

7. Carefully tilt the patient's head back and adjust so their Frankfort line is parallel with the floor.

8. Direct the patient to swallow first before closing their mouth and to remain in their current position until image acquisition is complete.

Frankfurt plane

English

9. Click the READY button. The x-ray exposure has not started yet.

10. Now go to 7.3 X-ray Exposure to begin operation.

PaX-i3D Smart

91 I

7. Acquiring CEPH images

7.2.4

Waters View Mode

1. Rotate the ear rods 90° clockwise from their initial position as shown in the figure.

Nasal Positioner

Ear Rod

Porion position

reference indicator

2. Fold the nasal positioner up. The nasal positioner is not used in Frontal mode.

3. Guide the patient to the CEPH unit.

4. Ask the patient to stand upright facing the sensor. Make sure that the patient’s

5. Use the Vertical Frame Up/Down button or switch option to adjust the height of

6. During operation, properly align the ear rods with the patient's ears so their head

Use the Porion position reference indicator that appears in the acquired image to easily confirm the location of Porion.

shoulders are level and that his/her neck is relaxed.

the CEPH Unit to approximately match the height of the patient.

does not move.

After adjusting the height of the column, align the ear rods and nasal positioner with the patient.

PaX-i3D Smart

92 I

7. Acquiring CEPH images

7. Direct the patient to swallow and close their mouth, and guide the patient's head back 30˚ - 40˚. Direct the patient to remain in the current position until image acquisition is complete.

30-40

8. Click the READY button. The x-ray exposure has not started yet.

9. Now go to 7.3 X-ray Exposure to begin operation.

7.2.5

CARPUS Mode

Installing the Carpus Plate

❚

English

1. Align the end of the nasal positioner to the carpus plate groove so it is attached to the nasal positioner.

Locking bolt

Nasal positioner

Fixed bolt

Notch

CARPUS Plate

PaX-i3D Smart

93 I

Vatech PaX-i3D Smart, PHT-30LFO User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1. General Information

Manufacturer’s Liability

Owner and Operator’s Obligations

Conventions in this Manual

Marks and Symbols

2. Warnings and Precautions

General Safety Precautions

Electricity-related Safety Precautions

Radiation Safety

Warnings

3. Imaging System Overview

Introduction

Imaging System Configuration

Equipment Overview

4. Imaging Software Overview

PC Specifications

EasyDent / EzDent-i

Console Software

5. Getting Started

Turning On Equipment

Running the Image Viewer

Initiating the Console Software

6. Acquiring PANO images

Setting Exposure Parameters

Patient Positioning

X-ray Exposure

Finishing Scan

Confirming Image

7. Acquiring CEPH images

Setting Exposure Parameters

Patient Positioning