PaX I3d

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The manual provides guidance on safely operating the PaX-i3D dental imaging system

The main components include the X-ray source, detector, positioning accessories, and software

The examination modes available are PANO, CEPH, and CBCT modes

User Manual

Model : PHT-6500
Version : 1.44

ENGLISH

Full Version

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Table of Contents

Table of Contents

1
General Information........................................ 10
1.1
Notice................................................................................... 10
1.2
Manufacturer's Liability......................................................... 11
1.3
Owner and Operator's Obligations....................................... 11
1.4
Conventions in this Manual.................................................. 12

2
Warnings and Precautions............................. 14
2.1
General Safety Precautions.................................................. 14
2.2
Electricity-related Safety Precautions................................... 17
2.3
Radiation Safety .................................................................. 19
2.4
Warnings.............................................................................. 19

3
PaX-i3D Imaging System Overview............... 24
3.1
Introduction........................................................................... 24
3.1.1
System Components.............................................................24
3.1.2
Features.................................................................................24
3.1.3
The PaX-i3D Options.............................................................25
3.1.4
Standards and Regulations...................................................26

3.2
Imaging System Structure.................................................... 27
3.3
General View of the PaX-i3D................................................ 29
3.3.1
Laser Beams .........................................................................31
3.3.2
The Exposure Switch.............................................................31
3.3.3
Emergency Stop Switch.........................................................32
3.3.4
Components and Positioning Accessories............................33

3.4
Examination Programs and Exposure Time......................... 34
3.4.1
PANO Mode...........................................................................34
3.4.2
CEPH Mode...........................................................................36
3.4.3
CBCT Mode...........................................................................36

3.5
Marks and Symbols.............................................................. 38

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Table of Contents

4
Software Overview.......................................... 42
4.1
PC System Requirements (Recommended)........................ 42
4.2
EasyDent.............................................................................. 43
4.3
Imaging Software Overview.................................................. 44
4.3.1
PANO Mode...........................................................................49
4.3.2
CEPH Mode...........................................................................52
4.3.3
CBCT Mode...........................................................................54

5
Getting Started................................................ 58
5.1
Turning on the PaX-i3D........................................................ 58
5.2
Running the Image Viewer – EasyDent................................ 59
5.2.1
Creating a New Patient Record.............................................60
5.2.2
Retrieving Patient Records....................................................62

5.3
Initiating the Imaging Program.............................................. 63

6
Acquiring PANO Images................................. 66
PANO Imaging Program................................. 66
6.1
6.2
Setting Exposure Parameters........................ 71
6.3
Positioning the Patient................................... 74
6.3.1
PANO Standard.....................................................................75
6.3.2
TMJ Open .............................................................................79
6.3.3
TMJ Close..............................................................................82
6.3.4
Sinus......................................................................................83

6.4
Initiating X-Ray Exposure..................................................... 86

7
Acquiring CEPH Images................................. 90
7.1
Setting the Exposure Parameters......................................... 90
7.2
Positioning the Patient.......................................................... 94
7.2.1
Lateral (Full Lateral)...............................................................95
7.2.2
Frontal (PA)...........................................................................97

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Table of Contents

7.2.3
SMV.......................................................................................99
7.2.4
Waters View.........................................................................100
7.2.5
CARPUS..............................................................................101

7.3
Initiating X-Ray Exposure................................................... 103

8
Acquiring CT Images.................................... 108
8.1
Setting the Exposure Parameters....................................... 108
8.2
Positioning the Patient........................................................ 112
8.3
Acquiring a SCOUT image................................................. 117
8.3.1
Starting imaging with the SCOUT feature............................118
8.3.2
SCOUT Viewer....................................................................120
8.4
Initiating X-Ray Exposure....................................................121

9
Troubleshooting............................................ 126

10
Cleaning and Maintenance........................... 128
10.1
Cleaning............................................................................. 128
10.2
Maintenance....................................................................... 129

11
Disposing of the Unit.................................... 132

12
Technical Specifications.............................. 134
12.1
Mechanical Specifications.................................................. 134
12.2
X-Ray Generator................................................................ 137
12.3
Electrical Specifications...................................................... 142
12.4
Environmental Specifications............................................. 142

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Table of Contents

Appendices
1 Recommended X-Ray Exposure Table........ 144
1.1
PANO................................................................................. 144
1.2
CEPH.................................................................................. 144
1.3
CBCT.................................................................................. 145

2
X-Ray Dose Data............................................ 146
2.1
DAP Table.......................................................................... 146
2.2
CTDI (CT Dose Index)........................................................ 147
2.3
X-Ray Scatter Dose ........................................................... 148

3. 
Electromagnetic Compatibility (EMC)
Information .................................................... 150

4. 
Acquiring image for the pediatric dental
patient............................................................. 154
4.1
Age group: classification table............................................ 154
4.2
Positioning the pediatric dental patient............................... 154
4.3
Setting exposure values to the age group.......................... 155
4.4 
The references pertinent to the potential risks for
the pediatric patients......................................................... 155

5
Abbreviations................................................ 158

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1
General Information

1.1
Notice................................................................................... 10
1.2
Manufacturer's Liability......................................................... 11
1.3
Owner and Operator's Obligations....................................... 11
1.4
Conventions in this Manual.................................................. 12

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1 General Information

1
General Information

1.1
Notice

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

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


PANO, CEPH, and 3D CT imaging capabilities into a single system.

The user manual is a part of the product. This manual describes how to operate
the PaX-i3D 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.

The QR code linked to video file about image capture for the PANO Standard
and CEPH Lateral is provided in the manual. The smart phone and pad which
have the QR code reader application program can be used to watch video.

Due to a constant technological improvement, this 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:

VATECH Co., Ltd.

Phone: +82-1588-9510

E-mail: [email protected]

This document is originally written in English.

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

Manual Name: PaX-i3D (Model: PHT- 6500) User Manual

Version: 1.44

Publication Date: 2018-05

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1 General Information

1.2
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.

1.3
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 10 Cleaning and Maintenance.

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1 General Information

1.4
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.

Indicates information that should be followed


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

Indicates a situation that demands prompt


CAUTION and careful action, a specific remedy, or
CAUTION emergency attention.

Indicates a possible danger of exposure to


X-Ray
radiation.
X-RAY
Indicates a situation or action that could
IMPORTANT potentially cause problems to the equipment
IMPORTANT and/or its operation.

Emphasizes important information or provide


NOTE
useful tips and hints.
NOTE

Indicates a component which must be replaced


SINGLE USE
for each new patient.

To prevent personal injury and / or damage to the equipment, please observe


all warnings and safety information included in this document.

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2
Warnings and Precautions

2.1
General Safety Precautions.................................................. 14
2.2
Electricity-related Safety Precautions................................... 17
2.3
Radiation Safety................................................................... 19
2.4
Warnings.............................................................................. 19

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2 Warnings and Precautions

2
Warnings and Precautions
Be sure to strictly observe all warnings and safety
WARNING 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.

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

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2 Warnings and Precautions

■■ 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.

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

Hygiene

Always disconnect the equipment from the power outlet


CAUTION when disinfecting 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.

■■ Disinfect the components (bite block, temple supports etc.) of the equipment
that come into contact with the patient or the operator after each exposure.

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2 Warnings and Precautions

■■ The user should apply single use disposable barrier membranes to the bite
block and all other patient contacting surfaces, and these barriers must be
removed and replaced with unused barriers for each patient.

■■ 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

IMPORTANT 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. 24 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
be cease and an error message will be displayed. Normal X-Ray capabilities
will resume after the generator reaches 58 °C (136.4 ℉).

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.

Emergency stop

■■ If a problem occurs during image acquisition, press the red emergency


stop switch to immediately stop all moving parts and cut off all power to the
equipment.

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2 Warnings and Precautions

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 ℉ to 95 ℉) 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 ℉).

■■ 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.

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.

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2 Warnings and Precautions

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

■■ 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.

■■ In normal condition, the enclosure leakage current from or between parts of


the system within the patient environment shall not exceed 0.1 mmA. If the
value exceeds the limit, it should be provided common protective earth.

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

■■ The PaX-i3D X-Ray unit 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.

ElectroStatic Discharge

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

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2 Warnings and Precautions

2.3
Radiation Safety

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
WARNING
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.

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

As a manufacturer of radiology equipment that conforms


to stringent protection standards around the world, we
WARNING 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.

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2 Warnings and Precautions

X-Ray equipment is hazardous to patient and the operator


if proper exposure safety measures and/or operating
instructions are not observed.
WARNING
It is important to read this user manual carefully and
strictly abide by all warnings and cautions stated within it.

-- PaX-i3D 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.
WARNING

-- PaX-i3D 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.

Lasers

■■ 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


CAUTION
and do not make any changes to the settings or processes
that are described in these operating instructions.

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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 switch
located on top of the handle frame 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.

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.

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.
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3
PaX-i3D
Imaging System Overview

3.1
Introduction........................................................................... 24
3.1.1
System Components.............................................................24
3.1.2
Features.................................................................................24
3.1.3
The PaX-i3D Options.............................................................25
3.1.4
Standards and Regulations...................................................26

3.2
Imaging System Structure.................................................... 27
3.3
General View of the PaX-i3D................................................ 29
3.3.1
Laser Beams .........................................................................31
3.3.2
The Exposure Switch.............................................................31
3.3.3
Emergency Stop Switch.........................................................32
3.3.4
Components and Positioning Accessories............................33

3.4
Examination Programs and Exposure Time......................... 34
3.4.1
PANO Mode...........................................................................34
3.4.2
CEPH Mode...........................................................................36
3.4.3
CBCT Mode...........................................................................36

3.5
Marks and Symbols.............................................................. 38

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3 PaX-i3D Imaging System Overview

3
PaX-i3D Imaging System Overview

3.1
Introduction

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


Panoramic (PANO), Cephalometric (CEPH), and 3D CT imaging capabilities
into a single system.

The PaX-i3D system uses the advanced sensors to produce the higher quality
of image in 2D and 3D of the head region, including the dental / maxillofacial
regions, for planning and diagnostics.

The PaX-i3D may only be used by dentists, X-Ray technicians and other
professionals who are licensed to perform X-Rays by the law of the region
in which it is being used (The PaX-i3D may be used for ENT (Ear, Nose and
Throat) examination in countries requiring the CE marking).

3.1.1
System Components
■■ PaX-i3D digital X-Ray equipment
■■ PC
■■ EasyDent: 2D viewer and patient management software
■■ Imaging software
■■ Ez3D plus: 3D viewer

3.1.2
Features

■■ A 3-in-1 imaging solution: PANO, CEPH and CBCT imaging combined in


single equipment.

■■ Improved image processing algorithms:


-- Magic PAN: A high quality image reconstructed from the optimal auto-focused
images in each segment throughout the panoramic region to correct the improper
patient positioning and rotating unit’s trajectory.

-- Metal Artifact Reduction: Metal artifacts are minimized to improve image


quality.

■■ Multi-FOV (Field Of View): FOV is selected according based on the most


suitable ROI.

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3 PaX-i3D Imaging System Overview

■■ Provides an auto-switching between 2 sensors for the PANO and CBCT


imaging, without the intervention of the operator.

■■ CAN (Controlled Area Network) is employed to provide reliability and


dependability.

■■ 3D Viewer Ez3D plus: Enables 3D images to be analyzed accurately,


leading to greater diagnostic precision.

■■ DICOM file support: The standard file format for medical applications.

3.1.3
The PaX-i3D Options

The following options are all based on the PaX-i3D.

Item Description Remark

PaX-i3D PANO + CBCT 2 in 1

PANO + CBCT + CEPH


PaX-i3D SC 3 in 1
(scan type)
PANO + CBCT + CEPH
PaX-i3D OP Premium 3 in 1
(one shot type)

Item Description FOV Sensor

Multi FOV (mm)


Xmaru1215CF-
120 x 90 M PANO and CBCT 120 x 90, 80 x 80,
Plus
80 x 50, 50 x 50

Multi FOV (mm)


80 X 80 M PANO and CBCT 80 x 80, 80 x 50, Xmaru0712CF
50 x 50

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3 PaX-i3D Imaging System Overview

3.1.4
Standards and Regulations

Standards:

The PaX-i3D is designed and manufactured to meet the following standards:

IEC/EN/UL 60601-1, IEC/EN 60601-1-1, IEC/EN 60601-1-2,

IEC/EN 60601-1-3, IEC/EN 60601-2-7, IEC/EN 60601-2-28,

IEC/EN 60601-2-32, IEC/EN 60601-2-44, ISO 9001, ISO 13485

NEMA standard publication PS 3.1-3.18, 2008

X-Ray source assembly [HDG-07B10T2] IEC 60601-2-28 (1993)

The CE symbol grants this equipment compliance with the European


Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a
class IIb device.

This equipment received the CSA certification mark in accordance with


CAN/CSA C22.2 No.601.1 regulations.

Classifications (IEC60601-1 6.1):

Protection against the ingress of water: Ordinary Equipment: IPX0

Protection against electric shock: Class 1 equipment, Type B Applied Parts

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3 PaX-i3D Imaging System Overview

3.2
Imaging System Structure

PaX-i 3D
UP/DOWN switch
(Optional)

Ethernet Cable: CAT5 (Optional: OneShot CEPH)


Fiber Optic Cable 10 m(32.8’)
Exposure switch

1
SIGNAL INPUT

WARNING SYSTEM BOX

LAMP INPUT LAMP OUTPUT

RS232 serial
Warning system panel cable 10 m(32.8’)

PC w/ imaging and
Warning lamp Door interlock image viewer programs

(Optional)

1. Signal input / output on PC

A. RS-232 in / out

B B. Ez3D plus Licence Key


C C. Keyboard input

D D. Mouse input
E E. Video out

F F. Ethernet cable: CAT5 (OneShot CEPH)

G G. Fiber optic cable in / out


G. (PANO / CT / Scan CEPH)

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3 PaX-i3D Imaging System Overview

2. Signal input / output at the column up / down switch (optional)

ATECH

External equipment intended for connection to signal


input, signal output or other connectors, shall comply with
relevant IEC Standard (e.g., IEC60950 for IT equipment and
IEC60601-1series for medical electrical equipment).

In addition, all such combination-system-shall comply with


NOTE the standard IEC60601-1 and/or IEC60601-1-1 harmonized
national standard or the combination.

If in doubt, contact a qualified technician or your local


VATECH representative.

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3.3
General View of the PaX-i3D

SCAN TYPE (Optional)


10
11
1 5
2 6
3 7 12
4

8 13
ONE SHOT TYPE (Optional)
14

COLUMN RETURN SELECT CHINREST

ⴗ ⴘ ⴙ ⴚ ⴛ

15

Item Details
CEPH imaging sensor (optional).
X-RAY SENSOR
1 -- Scan Type
(CEPH)
-- One shot Type
-- Positions the patient during CEPH imaging.
NASAL
2 -- The ruler for use to compensate the acquired
POSITIONER
image that is different from actual size.
Secures the patient’s head during CEPH
3 EAR RODS
imaging.

SECONDARY Limits the X-Ray irradiation field for CEPH


4
COLLIMATOR scanning.

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3 PaX-i3D Imaging System Overview

Item Details

Sensors: used for CT and PANO imaging.


This module consists of two different sensors
X-RAY SENSOR that perform different functions (CT and PANO).
5
(PANO / CT) When you select a scanning mode, the sensor
will be switched automatically (CT ↔ PANO,
and vice versa).
TEMPLE Supports the patient’s temples during PANO
6
SUPPORT scan.

7 CHINREST Supports the patient’s chin during imaging.

TELESCOPIC Moves the column up or down for patient


8
COLUMN positioning.
STATIONARY
9 The portion of the column fixed to the base.
COLUMN
Indicates current exposure activity.
10 LED LAMP Green: Ready
Orange: X-Ray On
Rotates around the patient’s head during
11 ROTATING UNIT
exposure (depending on the imaging mode).

12 X-RAY TUBE The source of X-Ray emission.

Held firmly by the patient during imaging to


13 HANDLE FRAME
stabilize his / her position.

① COLUMN When COLUMN selected, the LED light is on.

Enables the rotating unit to return to an initial


② RETURN
position for the next exposure.

③ UP / DOWN Moves the Column / Chinrest up / down.


Mode selection: COLUMN, CHINREST w/ LED
14
on.
④ SELECT -- Works only for the CT mode. When touched,
the LED is ON on the CHINREST.
-- Disabled in PANO and CEPH modes.
When CHINREST selected, the LED light is on
⑤ CHINREST
-- Fine adjustment in the CT mode.

15 BASE Used to balance and stabilize the equipment.

The structural overview of the PaX-i3D may differ


depending on the model. For more information, refer to
NOTE section 3.1.3 The PaX-i3D Options.

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3 PaX-i3D Imaging System Overview

3.3.1
Laser Beams

2 3

1
4
5

COLUMN RETURN SELECT CHINREST

1. Frankfurt laser beam (Front): PANO 4. CT horizontal laser beam (Lateral: Upper):
2. Mid-sagittal plane laser beam (Front): 4. Large FOV
2. PANO / CT 5. CT horizontal laser beam (Lateral: Lower):
3. Canine laser beam (Lateral): PANO 5. Small FOV
6. CT vertical laser beam (Lateral)

3.3.2
The Exposure Switch

Exposure Indicator light The exposure switch allows the operator


Green: Ready to control image acquisition from outside
Orange: Exposure
of the X-Ray room. Press and hold the
exposure switch down until acquisition is
complete.
Premature release of the exposure switch
Exposure Button
will abort image acquisition. Pressing the
exposure switch activates the orange
indicator light to indicate that the X-Ray is
being emitted.

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3.3.3
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.

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3.3.4
Components and Positioning Accessories

The following accessories can be disinfected after they have been separated
from the equipment. Disinfect all accessories which come into direct contact
with the patient, such as the bite block, chin support or temple supports, using
an alcohol-based solution and allow them to dry before use.

Accessories Order No.

Chin support w/ bite block: M0400419 /


Normal M0400145

Chin support: Edentulous M0400421

Chin support: TMJ M0400422

Chin support: Sinus M0400420

M0400835 : L
Temple supports
M0400836 : R

Carpus plate M0100074

Hygiene cover for bite block Panorama Cover

(single use) 300 pcs

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3.4
Examination Programs and Exposure Time

The PaX-i3D has been designed to carry out the following radiological
examinations:

-- PANO

-- CBCT

-- CEPH

3.4.1
PANO Mode

PANO Type:

Version Mode Option


Basic PANO examination / Special examination
Magic PAN PANO examination: Standard optional

Magic PAN: A high quality image reconstructed from the


optimal auto-focused images throughout the panoramic
region to correct the improper patient positioning and
NOTE
rotating unit’s trajectory.

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Exposure Time (Max. 20.2 s)

Scan Time (s)


Examination Arch Selection Examination Mode
HD Normal
Standard 13.5 10.1
Right 6.7 5.1
Narrow
Front 11.1 8.4
Left 6.7 5.1
Standard 13.5 10.1
Right 6.7 5.1
Normal
Front 11.1 8.4
Left 6.7 5.1
Standard 13.5 10.1
Right 6.7 5.1
Wide
Front 11.1 8.4
PANO Left 6.7 5.1
Examination Standard 11.5 8.6
Right 5.7 4.3
Child
Front 9.2 6.9
Left 5.7 4.3
Standard 13.5 10.1
Right 9.6 7.2
Front 2.5 1.9
Left 4.8 3.6
Orthogonal
Bitewing 4.8 3.6
Bitewing Incisor 2.5 1.9
Bitewing Right 4.8 3.6
Bitewing Left 4.8 3.6
TMJ LAT Open
6.1 4.6
TMJ LAT Close
Special TMJ PA Open
7.0 5.3
Examination TMJ PA Close
Sinus LAT 6.0 4.5
Sinus PA 10.3 7.7

- : Indicates that the examination supports Magic


PAN .
NOTE
- Maximum exposure time deviation: ± 10 % (IEC 60601-2-7)

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3.4.2
CEPH Mode

Scan Type Sensor (optional)

Examination Modes Scan Time (s) - Default


Lateral / PA / SMV / Waters View / Carpus 12.9
Full Lateral 16.9

One shot Type Sensor (optional)

Examination Modes Scan Time (s) - Default


Lateral 0.9
PA / SMV / Waters View / Carpus 1.2

Exposure time can be adjusted by resolution of 0.1 s in the


range of 0.7 s to 1.2 s (One shot type only).
NOTE

3.4.3
CBCT Mode

FOV & Examination Positioning

Horizontal Position
FOV Size (mm) Vertical Position
Right Center Left
Mx. O
Occl. X
50 x 50 specific tooth selection
Mn. O
TMJ X
Mx. O O O
Occl. O O O
80 x 50 / 80 x 80
Mn. O O O
TMJ O X O
Mx. X O X
Occl. X O X
120 x 90
Mn. X O X
TMJ X X X

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Image Reconstruction

Image reconstruction time varies depending on computer specifications and / or


working conditions. The Xmaru series stand for the individual sensor.

* MAR: Metal Artifact Reduction

[Xmaru1215CF- plus sensor]

Reconstruction Time (s)


Voxel STANDARD HIGH File Size
FOV (mm) (Scan Time: 15 s) (Scan Time: 24 s)
Size (MB)
*MAR *MAR *MAR *MAR
Skip Apply Skip Apply
0.120 22 67 39 98 138
50 x 50
0.200 19 52 32 78 30
0.200 24 68 37 105 76.5
80 x 50
0.300 19 61 32 92 21.8
0.200 32 110 54 168 122
80 x 80
0.300 27 96 43 148 35
0.200 44 169 71 274 310
120 x 90
0.300 34 125 57 182 91.5

The test condition: LENOVO Workstation E30: Intel Xeon E3-1230 3.20Ghz
CPU, 4GB RAM, NVIDIA Quadro 600 VGA Card.

[Xmaru0712CF sensor]

Reconstruction Time (s)


Voxel STANDARD HIGH File Size
FOV (mm) (Scan Time: 15 s) (Scan Time: 24 s)
Size (MB)
*MAR *MAR *MAR *MAR
Skip Apply Skip Apply
0.120 31 72 44 102 137
50 x 50
0.200 23 55 39 84 29
0.200 30 66 46 110 75.6
80 x 50
0.300 23 56 38 89 21.2
0.200 40 103 55 132 122
80 x 80
0.300 31 80 48 126 35

The test condition: HP Workstation Z400: Intel Xeon w3550 @ 3.07 GHz
CPU, 3 GB RAM, NVIDIA Quadro 600 VGA Card.

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3.5
Marks and Symbols

Symbols Description Location


Alternate current
Attention: consult accompanying
Label
documents

Dangerous voltage Power board

Protective earth (Ground) Power board

Off (power: disconnect from the main


Main switch
switch)

On (power: connect to the main switch) Main switch

TYPE B Equipment Label

Radiation hazard Label

EC representative Label

The CE symbol indicates that this


product complies with the European
Directive for Medical Devices 93/42/ Label
EEC as amended by 2007/47/EC as a
class IIb device.

CSA mark
Label
No.266436

Address where the equipment was


Label
manufactured
This symbol indicates that electrical
and electronic equipment must not
be disposed of as unsorted municipal Label
waste and must be collected
separately.
MCU board/
This symbol warns ESD hazard.
Board package
This symbol indicates that this
equipment is classified as a CLASS 1
Label
LASER PRODUCT in accordance with
IEC 60825-1 ED.1 regulations.

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Symbols Description Location


Caution: Federal law restricts this
device to sale by or on the order of a Label
licensed healthcare practitioner.
Indicates that the user needs to refer
Label
to the Instruction Manual.

Indicates the date of manufacture. Label

Indicates the manufacturer's serial


number so that the specific equipment Label
can be identified.

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3.5.1
Label Locations

The label is attached to the right side of the equipment and it consists of 5 parts
as below.

No. Item

1 Main Label

CAUTION Label
2
- X-ray / Attention: X-ray on when equipment in operation.

3 X-RAY GENERATOR Label

4 CLASS 1 LASER PRODUCT Label

Manufacturer Label
5
- The date of manufacture / Serial Number

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4
Software Overview

4.1
PC System Requirements (Recommended)........................ 42
4.2
EasyDent.............................................................................. 43
4.3
Imaging Software Overview.................................................. 44
4.3.1
PANO Mode...........................................................................49
4.3.2
CEPH Mode...........................................................................52
4.3.3
CBCT Mode...........................................................................54

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4 Software Overview

4
Software Overview
2 programs come with this equipment to acquire, process, and view the image:
■■ EasyDent: 2D viewer, analysis, and patient management
■■ Imaging software: PANO / CEPH / CBCT

4.1
PC System Requirements (Recommended)

-- The PC system plays a large role in processing and


viewing quality images. Image quality may be diminished
if the PC specifications are not met. Please adhere to the
requirements specified in the following table.
--
-- If necessary, upgrade your PC’s system configuration to
NOTE
meet the following specifications.
--
-- DO NOT place the PC or peripheral equipment connected
to the PC in the immediate vicinity of the patient.

Item Specifications
CPU E5-1607v4 4C 3.1GHz 2133 10MB
Chipset Intel® C612
RAM 1x4GB DDR4-2400 Registered RAM
HDD 500GB SATA 7200 rpm
Graphics board NVIDIA Quadro K620 2GB
Integrated Intel I218LM PCIe GbE Controller Intel
Ethernet Interface
Ethernet I210-T1 PCIe NIC (Option)

Serial Port (RS232) HP Serial Port Adapter Kit (Option)

Power Supply ≥ 700 Watts (90% efficient)


2 PCI Express Gen3 x16 slot
1 PCI Express Gen3 x 8 Slot
Slots 1 PCI Express Gen2 x 4 Slot
1 PCI Express Gen2 x 1 Slot
1 PCI 32bit/33MHz
CD/DVD drive DVD Writer 5.25"
Windows 7 Professional 64-bit (available through
Operating System
downgrade rights from Windows 10 Pro)
Recommended
HP Z440
System

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4 Software Overview

Item HP LENOVO

1 PCI Express Gen3 x8 Slot


1 PCI Express Gen3 x16 Slot
2 PCI Express Gen3 x16 slot
1 PCI Express Gen2 x16 Slot
Slots 1 PCI Express Gen2 x8 Slot
1 PCI Express Gen2 x1 Slot
1 PCI Express Gen2 x4 Slot
1 PCI Slot 1 PCI Slot
DVD-ROM, DVD+/-RW, DVD-ROM DVD R/W, Blu-
CD/DVD drive
Blu-Ray Ray R/W
19” 1280 x 1024 screen 19” 1280 x 1024 screen
Monitor
resolution resolution
Operating Windows 7 Professional Windows 7 Professional
system 64-Bit OS 64-Bit OS
Recommended
Z420 P300
system

4.2
EasyDent

As the basic imaging platform for all VATECH dental X-Ray equipment,
EasyDent is designed to be easy to use. Both the Imaging Program and the
3D Viewer are interfaced with EasyDent. Images acquired by the Imaging
Program are imported directly into EasyDent, where analysis and diagnosis
can be performed quickly and easily.

EasyDent has the following key features:

■■ 2D viewer, image analysis and patient information management

■■ Extra oral/intraoral image management

■■ 3D image management

The screenshot below is of EasyDent’s initial GUI window.

For details about patient search, refer to sections 5.2.1 Creating a new patient
record and 5.2.2 Retrieving patient records.

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4.3
Imaging Software Overview

Imaging parameters can be set using the imaging program. The following
screenshot shows the main interface in PANO mode.

For details concerning PANO, CEPH, and CBCT imaging, refer to sections 4.3.1
- 4.3.3.

I J K L M

A
N

D
E

F
P

G H O

A. Imaging Mode Display

This displays the current imaging mode.

-- Indicates that the Magic PAN is supported in the PANO


imaging modality.
NOTE
-- Is displayed only for the ‘Standard’ mode, with the Magic
PAN enabled.

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B. Scanning Status and Image Preview Window

This shows image acquisition progression in real- time.

C. Patient Information

This displays information about the selected patient.

D. Imaging Guide Window

This displays various text instructions for the operator to follow.

E. Scan Time and DAP Display Window

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

F. Tube Voltage and Current Adjustment

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.

Adjustable resolution:
-- Tube voltage: ± 1 kVp
NOTE -- Tube current: ± 1 mA(PANO, CEPH), ± 0.1 mA(CT)

For the tube voltage and its correspondence with the


current patient, refer to Appendix 1: Recommended X-Ray
NOTE Exposure Table.

G. Patient Gender

This displays the current patient’s gender as entered in EasyDent’s patient


information. If necessary, gender can be manually selected.

Age Group / Gender VATECH’s Standard


Child ≤ 12
Man
Adult ≥ 13
Woman

H. X-ray intensity

This tool select X-ray intensity.

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Depending on the circumference of the patient’s head,


X-ray intensity may be classified as Hard, Normal, or Soft :

Soft ≤ Normal ≤ Hard

Classification
Average head Range
Age Group of head
circumference (cm)
circumference
> 53±3 Hard
NOTE
Child 53±3 cm 53±3 Normal
53±3 < Soft
> 56±3 Hard
Adult 56±3 cm 56±3 Normal
56±3 < Soft

I. 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.
NOTE
If correct, click the ‘Confirm’ button.
4. Align the Phantom Jig, and click the ‘Ready’ button.
5. Press and hold down the exposure switch.

J. Manual Image Reconstruction

If automatic reconstruction of the image fails, use this function to reconstruct


the image manually. Select Modality and click Search Reconstruction.

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4 Software Overview

K. Laser Beam On / Off Button

Use this icon to turn the laser beam on or off for patient positioning.

L. Setting

This Control Panel displays and sets various equipment-related parameters,


including language, automatic save, DAP display unit, etc. Settings are
classified into two groups: operator and installer.

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4 Software Overview

M. Exit

This button exits the capturing program.

N. Imaging Mode

This toggles the imaging mode.

Refer to section 4.3.1 ~ 4.3.3 for the details regarding PANO, CEPH and CBCT
imaging modes.

O. Confirm

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

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.
NOTE

P. Ready

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

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4.3.1
PANO Mode

A. PANO TYPE
One of two modes (Magic PAN or Normal)
can be selected for PANO imaging.

A Magic PAN (optional): a feature to acquire


the sharper image. When enabled, the

B symbol appears on the upper right for


the imaging modes which incorporate this
feature.
C

B. Image Quality

One of three modes (UHD, HD or Normal) can be selected for PANO imaging.

■■ HD: Image with higher resolution than Normal Mode

■■ Normal: Normal image

Setting the default mode in the PANO:

The most frequently used mode among the HD and Normal


can be configured as the default, which requires the
authority.

To change the default mode,


NOTE

1. Ask the engineer in your region for the mode change.

2. Re-run the imaging program after setting up the related


parameters.

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4 Software Overview

The default mode, if any, specified in a specific country


CAUTION can't be changed for the user's intent.

C. Arch Selection

Select the patient’s arch type: Narrow, Normal, Wide, Child, and Orthogonal.

Orthogonal: Enables the image to be acquired with overlapping regions of the


teeth minimized.

D. PANO Examination

Acquire the image for a specific ROI in panoramic mode.

Mode Region of Interest: PANO Image

Standard Imaging standard images

Right Imaging lateral right

Front Imaging frontal area

Left Imaging lateral left

The following table summarizes the sub-modes for orthogonal imaging.

Orthogonal mode: Acquires an image that minimizes overlapping regions of


teeth.

Sub-mode Region of Interest: Orthogonal

Standard Imaging PANO Standard image

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Sub-mode Region of Interest: Orthogonal

Right Imaging PANO lateral right

Front Imaging PANO frontal area

Left Imaging PANO lateral left

Bitewing Left / Right

Bitewing Incisor Incisor region

Bitewing
imaging

Bitewing Right Right region

Bitewing Left Left region

Special Examination

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Mode Details

Takes a side view image of the TMJ


TMJ LAT Open
with the mouth open.

Takes a side view image of the TMJ


TMJ LAT Close
with the mouth closed.

Takes a posterior/anterior
TMJ PA Open image of the TMJ with optional
the mouth open.
Takes a posterior/anterior
TMJ PA Close image of the TMJ with optional
the mouth closed.

Takes a side view image


Sinus LAT optional
of the sinus.

Takes a posterior-anterior image of


Sinus PA
the sinus.

4.3.2
CEPH Mode
Depending on the sensor type employed, one of the three kinds of imaging
program comes with the equipment for the CEPH mode examination.

1210SGA sensor 0910SGA sensor Xmaru2301CF sensor


(one shot type) (one shot type) (scan type)

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4 Software Overview

A. CEPH Examination

Mode Details

Lateral / Takes a lateral view image either partially


Full Lateral or fully

PA Takes a posterior-anterior image

SMV Takes a SMV(Sub-Mento Vertical) image

Waters
Takes a Waters View image
View

CARPUS Takes a CARPUS image

B. FOV Selection

The Multi FOV is supported for the equipment with the OS (one shot) CEPH
sensor (optional).

FOV Details
12 x 10 (inches)
Full size
30.48x25.40 (cm)
9 x 10 (inches) Region of the no interest of the rear part of the head is
22.86x25.40 (cm) eliminated to minimize the X-Ray exposure area.
8 x 8 (inches)
Child
20.32x20.32 (cm)

C. Exposure Time

One shot Type Sensor (optional)

Examination Modes Scan Time (s) - Default


Lateral 0.9

PA / SMV / Waters View / Carpus 1.2

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4 Software Overview

Exposure time can be adjusted by resolution of 0.1 s in the


range of 0.7 s to 1.2 s (One shot type only).
NOTE

Scan Type Sensor (optional)

Examination Modes Scan Time (s) - Default


Lateral / PA / SMV / Waters View / Carpus 12.9

Full Lateral 16.9

4.3.3
CBCT Mode

A A

B Xmaru0712CF Sensor

Xmaru1215CF Plus sensor

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4 Software Overview

A. FOV Size

This selects the FOV (Field Of View) size.

The FOV size is decided by the attached CT sensor


NOTE (optional).

B. Vertical Position

This selects the vertical imaging region: Mandible, Occlusion, Maxillary or


TMJ.

C. Horizontal Position

This selects the horizontal imaging region: Right, Center, or Left.

D. Image Quality

This selects the image acquisition speed: High (24 s) or Standard (15 s).

-- High: Higher quality image acquisition mode than


‘Standard’ mode.
NOTE
-- Standard: Fast scan mode with low X-Ray dose.

E. Voxel Size

High / Standard

FOV (mm) Mode Voxel Size (mm)


120 x 90 Standard 0.200
80 x 80
80 x 50 Application 0.300
Standard 0.120
50 x 50
Application 0.200

F. Metal Artifact Reduction

This function is used to reduce the artificial effect generated by patients with
metallic materials in their dental region and improve image quality. When Metal
Artifact Reduction is selected, the time required to reconstruct an image is
doubled.

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4 Software Overview

Setting the default mode in the CBCT:

The most frequently used mode under the Image Quality,


Voxel Size, Metal Artifact Reduction can be configured as
the default, which requires the authority to change.

NOTE To change the default mode,

1. Ask the engineer in your region for the mode change.


2. Re-run the imaging program after setting up the related
parameters.

The default mode, if any, specified in a specific country


CAUTION can't be changed for the user's intent.

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5
Getting Started

5.1
Turning on the PaX-i3D........................................................ 58
5.2
Running the Image Viewer – EasyDent................................ 59
5.2.1
Creating a New Patient Record.............................................61
5.2.2
Retrieving Patient Records....................................................62

5.3
Initiating the Imaging Program.............................................. 63

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5 Getting Started

5
Getting Started

5.1
Turning on the PaX-i3D

To turn on the system, follow the steps below:

A. Before turning the equipment on, check whether the system is correctly
connected and installed (check the connection status between the equipment
and the PC).

B. Turn the ON / OFF switch underneath the handle frame to the ON position.

OFF

ON
ATECH

C. Check whether the LED lamp on


Green: ON
top of the equipment is illuminated. If it
is illuminated, the equipment is ready
for image acquisition.

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5 Getting Started

D. Insert the license key for Ez3D plus


into the USB port on the back of PC.
The license key for Ez3D plus must
be attached to view or analyze the 3D
images.

License key for Ez3D plus

-- If it has not been used for a long time, allow at least


an hour before the first exposure since turning on the
IMPORTANT equipment.

-- Condensation could form inside the equipment if it is


a different temperature than the surrounding room.
Only turn on the equipment once it has reached room
temperature.
-- Wait at least 20 seconds after the equipment has been
CAUTION
turned off to turn it back on.
-- Allow the equipment to warm up for at least 5 minutes
before acquiring images or preferably more than 30
minutes for image quality.

Do not position the patient in the unit while it is initiating.


WARNING The patient could be injured if the equipment malfunctions.

5.2
Running the Image Viewer – EasyDent

EasyDent is a basic imaging platform for all VATECH’s dental X-Ray


equipments. Both the Imaging Program and 3D Viewer are interfaced with
EasyDent.

On your desktop, double-click EasyDent or click Start→All


Programs→EasyDent.

The EasyDent main window will be displayed.

Go to the section 5.2.1 ~5.2.2 to create or open an existing patient record.

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5 Getting Started

For detailed guide to using this software, please refer to


the EasyDent user manual.
NOTE

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5 Getting Started

5.2.1 Creating a New Patient Record

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

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

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.

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5 Getting Started

5.2.2 Retrieving Patient Records

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.

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5 Getting Started

5.3
Initiating the Imaging Program

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.

Please proceed to the next chapter.

Refer to chapters 6-8 for information regarding image


acquisition.
NOTE

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6
Acquiring PANO Images

6.1
PANO Imaging Program....................................................... 66
6.2
Setting Exposure Parameters............................................... 71
6.3
Positioning the Patient.......................................................... 74
6.3.1
PANO Standard (QR Code)...................................................75
6.3.2
TMJ Open .............................................................................79
6.3.3
TMJ Close..............................................................................82
6.3.4
Sinus......................................................................................83

6.4
Initiating X-Ray Exposure..................................................... 86

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6 Acquiring PANO Images

6
Acquiring PANO Images
This chapter requires the preparatory steps in Chapter 5 to have already been
completed. If you have not completed these steps, please return to Chapter 5
and complete the process outlined there before proceeding with this chapter.

6.1
PANO Imaging Program

EXAMINATION
EXAMINATION ARCH SELECTION
PROGRAM
Standard ①
Right
Narrow
Front
Left
Standard ②
Right
Normal
Front
Left
Standard ③
Right
Wide
Front
PANO Left
EXAMINATION Standard ④
Right
Child
Front
Left
Standard ⑤
Right
Front
Left

Orthogonal
Bitewing
Bitewing Incisor
Bitewing Right
Bitewing Left
TMJ LAT Open ⑦
TMJ LAT Close
SPECIAL TMJ PA Open ⑧
-
EXAMINATION TMJ PA Close
Sinus LAT ⑨
Sinus PA ⑩

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6 Acquiring PANO Images

① Narrow_Standard
A panoramic imaging mode for the patients with the V-shaped
arch trajectory (typically for some females).

② Normal_Standard
A panoramic imaging mode for the adult patients with the
normal arch trajectories.

③ Wide_Standard
A panoramic imaging mode for the patients with the square-
shaped arch trajectory (typically for some males).

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6 Acquiring PANO Images

④ Child_Standard
A panoramic imaging mode for the child arch trajectory, in
which case the X-Ray exposure is 40% less than that in
Normal mode.

⑤ Orthogonal_Standard
A panoramic imaging mode to minimize the overlapped
region of the teeth from the X-Ray exposure which is beamed
perpendicularly between teeth.

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6 Acquiring PANO Images

⑥ Orthogonal_Bitewing
A panoramic imaging mode to acquire an image only for the
region of interest through the orthogonal trajectory: Pros: less
X-Ray exposure than the Normal mode. Cons: TMJ and parts
of an image of the maxillary sinus are not acquired.

X-Ray ON X-Ray ON

X-Ray ON

⑦ TMJ LAT Open / Close


An imaging mode to acquire a lateral image of the TMJ, in
which the X-Ray beam is directed on the lateral TMJ region:
TMJ (Open and Close).

⑧ TMJ PA Open / Close


An imaging mode to acquire a TMJ image, in which the X-Ray
beam is directed on the frontal TMJ, with the patient's mouth
open fully and close (Open and Close).

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6 Acquiring PANO Images

⑨ Sinus LAT
A special imaging mode to acquire a Sinus image, in which
X-Ray beam is directed on the lateral region of the maxillary
sinus.

⑩ Sinus PA
A special imaging mode to acquire a Sinus image, in which
X-Ray beam is directed on the frontal region of the maxillary
sinus.

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6 Acquiring PANO Images

6.2
Setting Exposure Parameters

Perform the following procedures to select the capture parameters for the
specific patient and capture mode. For more details, refer to 4.3.1 PANO Mode.

A. Choose an imaging mode under


Imaging Mode.

B. Select the mode under PANO Type: Normal or Magic PAN.

Mode Details
Normal Normal image.

Magic PAN Image with ultra-high resolution optional

C. Select the image quality for the image.

Mode Details

Image with higher resolution than Normal


HD
Takes longer scan time than the Normal

Normal Normal image

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6 Acquiring PANO Images

D. Select the patient’s arch type under


Arch Selection. By default, Normal is
selected.
Orthogonal: This mode enables
overlapping regions of teeth to be
Click minimized when acquiring images in the
ROI. If orthogonal arch is selected, its
sub-modes are activated.

These sub-modes
activated

E. Select the ROI for panoramic image acquisition under PANO Examination.

F. The patient’s gender will be


automatically selected according to the
patient information registered in EasyDent.
Nevertheless, ensure that this information
is correct.

Age Group VATECH’s Standard

Child ≤ 12

Man
Adult ≥ 13
Woman

G. Select X-ray intensity.

X-ray intensity (Hard, Normal, Soft) is according to the


operator's decision.
NOTE
Soft≤Normal≤Hard

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6 Acquiring PANO Images

H. A default value for the tube voltage (kVp)


and current (mA) will be displayed based
on the gender and X-ray intensity.

If necessary, further adjustments can be made using the arrows to the right of
each number.

Adjustable resolution:

-- Tube voltage: ± 1 kVp


NOTE
-- Tube current: ± 1 mA

I. Click the Confirm button for these


parameters to take effect.

Please wait for a moment, while the rotating unit moves to


its initial scanning position.
NOTE

When you click the 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.

■■ The chin support will adjust itself according to the mode selected.

■■ Three laser beams, Mid-sagittal plane, Frankfurt plane and Canine, will be
activated to facilitate patient positioning. These beams will disappear after
20 minutes or if the Ready button is clicked.

The laser beam On / Off button ( ) is located in the


upper right side of the window.
NOTE

■■ The scan time and estimated DAP (Dose


Area Product) values will be shown on the
main display for the selected exposure.

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6 Acquiring PANO Images

J. Guide the patient to the equipment. Position the patient within the
equipment. For further information about patient positioning, refer to section 6.3
Positioning the Patient.

6.3
Positioning the Patient

Before Positioning the Patient

■■ Ask the patient to remove all jewelry and metallic objects, such as earrings,
hair pins, spectacles, dentures, and orthodontic appliances. These items
may cause shadow images which could obscure diagnosis.

■■ It is strongly recommended that the patient wear a lead apron for protection
against any possible scatter radiation.

■■ Adjust the column height to the patient’s height using the up / down button
or switch (optional).

UP

DOWN

Light on
COLUMN RETURN SELECT CHINREST

Column Up / Down
Up / Down buttons
switch (optional)

The SELECT button is disabled in PANO and CEPH modes.


NOTE

In general, imaging is performed with the patient in an


upright position.

However, a stool may be used for imaging patients with


NOTE special circumstances. If a stool is used, ensure that the
beams and movement of unit are not obstructed by the
stool

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6 Acquiring PANO Images

Correct positioning is an important factor in capturing the


best possible image. Proper positioning will reduce the
NOTE appearance of the cervical spine in the image.

Be careful not to project the laser beams directly into the


patient’s eyes as this could severely damage the patient’s
WARNING
vision.

6.3.1
PANO Standard

Positioning the patient

A. Insert the normal chin support and bite


block into the chin support receptacle on
the equipment.
Hygiene cover

B. Place a hygienic cover over the bite


block.
*To link to the video Bite block
manual: scan the
QR code with smart
phone or pad.

Chin support: Normal * For patients who lack teeth, use the
edentulous chin support. Refer to section
3.3.3 Components and Positioning
Accessories.

The hygiene cover for the bite block is intended for single
use only. Always replace the hygiene cover for each new
WARNING
patient.

Disinfect the chin support and bite block using an alcohol-


based cleaning solution and wipe away all residue with dry
CAUTION
cloth.

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6 Acquiring PANO Images

C. Loosen the Temple Supports by turning


the Temple Support Wheel.

Temple support wheel

D. Guide the patient — facing the chin support — to the equipment.

E. Adjust the height of the column using the column up / down button until the
patient’s chin rests comfortably on the chin support.

F. Ask the patient to:

■■ Stand upright

■■ Firmly grip the handle

■■ Lean his/her chest lightly against the


equipment

■■ Position his/her feet slightly forward and


open stance

G. Ensure that the patient’s shoulders


remain level and that his/her neck is
relaxed. The cervical spine should be
straight and upright.

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6 Acquiring PANO Images

H. Have the patient bite the bite block


along its grooves using his/her upper and
lower incisors (for edentulous patients, use
the edentulous chin support).

I. Have the patient

■■ Close his/her lips around the bite block

■■ Keep his/her tongue pressed against


his/her palate

■■ Close his/her eyes


Ask the patient to remain still until
scanning is completed.

To acquire the best image possible, ask the patient not to:

CAUTION -- Breathe or swallow saliva during image acquisition


-- Move during image acquisition

Aligning the Laser Beams

Clicking on the Confirm button after setting the parameters


for imaging will activate the three laser beams (Mid-sagittal
plane, Frankfurt plane and Canine) to facilitate patient
alignment. The beams will disappear after 20 minutes or if
NOTE the ‘Ready’ button is clicked.

To turn the laser beams On or Off, click the icon on


the imaging GUI.

Be careful not to project the laser beams directly into the


patient’s eyes as this could severely damage the patient’s
WARNING
vision.

A. Mid-sagittal plane laser beam: Position the Mid-sagittal plane laser beam
on the center of the patient’s face to prevent magnifications of the left or right
side in the final image.

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6 Acquiring PANO Images

B. Frankfurt plane laser beam: Position the patient’s head so that the
Frankfurt plane is aligned with the Frankfurt plane laser beam.

* The Frankfurt plane is the plane which joins the infra-orbital point to the
superior border of the external auditory meatus.

Mid-sagittal plane
laser beam

Frankfurt plane laser


beam

Canine laser beam

Frankfurt plane laser beam lever

C. Canine laser beam: Have the patient smile to properly position the canine
laser beam on the center of the patient’s canine tooth. Rotate the thumb wheel,
located under the patient support rest, forward or backward to properly align the
beam.

Canine laser beam

Canine laser beam lever

Completing Patient Positioning

A. After confirming patient positioning and beam alignment, adjust the temple
supports to fit snugly on both sides of the patient’s head using the temple
support wheel. The temple support wheel is located at the front of the patient
support rest.

B. Click the Ready button on the GUI after the patient has been properly
positioned. No X-Ray will be emitted at this point. The rotating unit will then
move into position for imaging.

C. Proceed to section 6.4 Initiating X-Ray Exposure.

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6 Acquiring PANO Images

6.3.2
TMJ Open

There are two TMJ sub modes: TMJ Open and TMJ Close. Scan a TMJ Open
image first and then scan a TMJ Close image. To prepare and position the
patient, follow the process outlined below.

-- Correct positioning is an important factor for image


capturing. Proper positioning will reduce the appearance
of the cervical spine in the reconstructed image.
IMPORTANT
--
-- For a child with a large head circumference, Man/Woman
mode may be selected instead of Child.

Positioning the patient

A. Insert the TMJ chin support.

CAUTION

Disinfect the chin support using an


alcohol-based cleaning solution and
wipe away all residues with dry cloth
before proceeding any further.

B. Loosen the Temple Supports by


turning the Temple Support Wheel at the
rare of the patient support table.

Temple support wheel

C. Guide the patient —facing the chin support — to the equipment.

D. Adjust the height of the equipment using the column up/down button until the
patient’s chin is resting on the chin support. Ensure that the chin is in contact
with the chin support.

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6 Acquiring PANO Images

E. Ask the patient to:

■■ Stand upright

■■ Firmly grip the handle

■■ Lean his/her chest lightly against the equipment

■■ Position his/her feet slightly forward.

F. For TMJ Open imaging, have the


patient:
Patient position with
chin support ■■ Open his/her mouth as wide as possible

■■ Keep his/her tongue positioned towards


the palate

■■ Breathe through his/her nose

■■ Close his/her eyes.


Be careful the chin not to touch any part of
the equipment.
The top of the TMJ support and the patient’s acanthion point must remain in contact
at all times during exposure.

G. Ensure that the patient’s shoulders remain level and that his/her neck is
relaxed. The cervical spine should be straight and upright.

H. Ask the patient to remain still until scanning is complete.

To acquire the best image possible, ask the patient not to:

CAUTION -- Breathe or swallow saliva during image acquisition


-- Move during image acquisition

Aligning the Laser Beams

Clicking on the Confirm button after setting the parameters


for imaging will activate the three laser beams (Mid-sagittal
plane, Frankfurt plane and Canine) to facilitate patient
alignment. The beams will disappear after 20 minutes or if
NOTE the ‘Ready’ button is clicked.

To turn the laser beams On or Off, click the icon on


the imaging GUI.

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6 Acquiring PANO Images

Be careful not to project the laser beams directly into the


patient’s eyes as this could severely damage the patient’s
WARNING
vision.

A. Mid-sagittal plane laser beam: Position the Mid-sagittal plane laser beam
at the center of the patient’s face to prevent magnifications of the left or right
side in the final image.

B. Frankfurt plane laser beam: Position


the patient’s head so that the Frankfurt
Mid-sagittal plane
plane is aligned with the Frankfurt plane
laser beam
laser beam.
Frankfurt plane laser
beam For proper positioning, adjust the way

Canine laser beam in which the patient’s head is tilted by


adjusting the height of the column using
the column up / down switch.
* The Frankfurt plane is a plane which
joins the infra-orbital point to the superior
border of the external auditory meatus.

C. Canine laser beam: Position the canine laser beam to the left corner of the
patient’s lips. Rotate the thumb wheel, located under the patient support rest,
forward or backward to properly align the laser.

Adjusting lever for the


Frankfurt plane laser

Adjusting lever for the canine laser

Completing Patient Positioning

A. After confirming patient positioning and beam alignment, adjust the temple
supports to fit snugly on both sides of the patient’s head using the temple
support wheel. The temple support wheel is located at the front of the patient
support rest.

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6 Acquiring PANO Images

B. Click the Ready button on the GUI after the patient has been properly
positioned. No X-Ray will be emitted at this point. The rotating unit will then
move into position for imaging.

C. Proceed to section 6.4 Initiating X-Ray Exposure.

6.3.3
TMJ Close

Scan a TMJ Open image first and then scan a TMJ Close
image. Guide the patient to close his / her lips for TMJ
Close imaging while maintaining the same position used
for TMJ Open imaging.
NOTE
The positions are the same for both modes, except for the
position of the lips.

A. Shortly after TMJ Open imaging has been completed, you will receive the
following message: “Do you want to take the TMJ Close image continuously?”
Press the OK button to capture a TMJ Close image.

B. For TMJ Close imaging, Have the


patient:

■■ Close his/her mouth

Acanthion Point ■■ Keep his/her tongue pressed against


his/her palate

■■ Close his/her eyes

The top of the TMJ support must remain in


contact with the patient’s acanthion point
during exposure.

Ask the patient to remain still until scanning is complete.

C. The laser beams should be aligned in the same way as for TMJ Open
imaging.

D. Proceed to section 6.4 Initiating X-Ray Exposure.

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6 Acquiring PANO Images

6.3.4
Sinus

Positioning the Patient

A. Insert the chin support (Sinus) into the


receptacle on the equipment.

CAUTION

Disinfect the chin support using an


alcohol-based cleaning solution and
wipe away all residues with a dry
cloth before proceeding any further.

B. Loosen the Temple Supports by


turning the Temple Support Wheel at the
rear of the patient support table.

C. Guide the patient —facing the chin


Temple support wheel
support — to the equipment. Have the
patient stand upright in the center of the
equipment.

D. Adjust the height of the equipment


using the column up / down button until
Light on COLUMN RETURN SELECT CHINREST
the patient’s chin rests comfortably on the
chin support.

Up / Down buttons

E. Ask the patient to:

■■ Stand upright

■■ Firmly grip the handle

■■ Lean his/her chest lightly against the equipment

■■ Position his/her feet slightly forward.

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6 Acquiring PANO Images

F. Ask the patient to press his/her lips


against the chin support.

G. Ensure that the patient’s shoulders


remain level and that his/her neck is
relaxed. The cervical spine should be
straight and upright.

H. Have the patient:

■■ Tilt his/her head back by 10-15°

■■ Close his/her mouth

■■ Keep his/her tongue pressed against


his/her palate

■■ Close his/her eyes

Ask the patient to remain still until


scanning is completed.

To acquire the best image possible, ask the patient not to:

CAUTION -- Breathe or swallow saliva during image acquisition


-- Move during image acquisition

Aligning the Laser Beams

Clicking on the Confirm button after setting the parameters


for imaging will activate the three laser beams (Mid-sagittal
plane, Frankfurt plane and Canine) to facilitate patient
alignment.

NOTE
The beams will disappear after 20 minutes or if the Ready
button is clicked. To turn the laser beams On or Off, click
the icon on the imaging GUI.

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6 Acquiring PANO Images

Be careful not to project the laser beams directly into the


patient’s eyes as this could severely damage the patient’s
WARNING
vision.

A. Mid-sagittal plane laser beam:


Frankfurt plane laser Position the Mid-sagittal plane laser
beam beam at the center of the patient’s face to
prevent magnifications of the left or right
Mid-sagittal plane
side in the final image.
laser beam

Canine laser beam


B. Frankfurt plane laser beam: The
Frankfurt plane laser beam should go from
the top of the ear to the tip of the nose
when the patient’s head is tilted back 10 –
15 °.

You may adjust the Frankfurt plane laser beam by manually adjusting the
Frankfurt plane laser beam lever.

C. Canine laser beam: Have the patient


smile to properly position the canine laser
beam on the center of the patient’s canine
tooth.
Rotate the thumb wheel, located under the
Adjusting lever for the
patient support rest, forward or backward
canine laser
to properly align the beam.

Completing Patient Positioning

A. After confirming patient positioning and beam alignment, adjust the temple
supports to fit snugly on both sides of the patient’s head using the temple
support wheel. The temple support wheel is located at the front of the patient
support rest.

B. Click the Ready button on the PC after the patient has been properly
positioned. At this point, X-Ray will not be emitted. The rotating unit will move to
position for imaging.

C. Proceed to section 6.4 Initiating X-Ray Exposure.

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6.4
Initiating X-Ray Exposure

The X-Ray exposure method and its sequences are the same for PANO
Standard and PANO Special modes. The example used in this manual is the
PANO Standard mode.

To emit the X-Ray, perform the following procedure.

If a problem occurs during image acquisition, press the


red emergency stop switch to immediately stop all moving
parts and cut off all power to the equipment’s electrical
components. You may then safely release the patient from
the equipment.

To reset this switch, turn it clockwise until it pops up.

WARNING

-- Do not operate the PC during exposure. Failure to


comply with this instruction may cause the system to
malfunction.
--
WARNING
-- The operator shall observe the X-Ray safety regulations
applicable to their area at all times during the operation
of this equipment.

If an emergency occurs during image acquisition, release


CAUTION the exposure switch to cease X-Ray emission.

A. Leave the X-Ray room and close the door. The operator must visually
monitor the patient at all times during image acquisition.

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6 Acquiring PANO Images

B. Press and hold down the exposure switch until image acquisition is
complete.

During X-Ray irradiation, ensure that


Exposure indicator
-- The LED lamp on top of the equipment
light turns orange
Orange: Exposure turns orange to indicate X-Ray emission.

-- The warning lamp outside the X-Ray


room turns on.

-- The announcement mode of either beep


or music is initiated, depending on the
set-up.

-- The radiation symbol on the upper left


X-Ray ON
corner of GUI turns yellow to indicate
X-Rays are being emitted.

C. The image appears in real time on the imaging GUI.

Ex) Magic PAN

Two images are obtained, with each in the Magic PAN and Normal respectively.
You would click either button to compare them with each other.

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6 Acquiring PANO Images

The buttons:

Normal

Magic PAN

D. Click the Save button to save the image.

E. The captured image will be automatically transferred to EasyDent. Clicking


the patient’s name in the patient list after imaging will refresh the image list for
that patient. The patient’s most recent image will appear on the far left of the
image window, as shown below.

Double-click an image to enlarge it for viewing or to check the quality of the


image.

After Image Acquisition

After acquiring the image, complete the following steps:

■■ Loosen the temple supports to release the patient.

■■ Remove the hygiene cover from the bite block (for standard PANO mode
only).

■■ Press RETURN to bring the Rotating Unit back to its initial position.

COLUMN RETURN SELECT CHINREST

RETURN button

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7
Acquiring CEPH Images

7.1
Setting the Exposure Parameters......................................... 90
7.2
Positioning the Patient.......................................................... 94
7.2.1
Lateral (Full Lateral) (QR Code)............................................95
7.2.2
Frontal (PA)...........................................................................97
7.2.3
SMV.......................................................................................99
7.2.4
Waters View.........................................................................100
7.2.5
CARPUS..............................................................................101

7.3
Initiating X-Ray Exposure................................................... 103

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7 Acquiring CEPH Images

7
Acquiring CEPH Images
This chapter requires all of the preparatory steps outlined in Chapter 5 to have
already been completed. If these steps have not been completed, return to
Chapter 5 and complete the setup processes outlined there before proceeding
to the processes outlined in this chapter.

7.1
Setting the Exposure Parameters

Perform the following procedures to set the exposure parameters for the
specific patient and capture mode (for more details about CEPH imaging, refer
to section 4.3.2 CEPH Mode).

Depending on the sensor type employed, one of three kinds of imaging S/W
comes with the equipment for the CEPH mode examination.

A
B

1210 SGA 0910 SGA Xmaru2301CF


(one shot type sensor) (one shot type sensor) (scan type sensor)

The Multi FOV is supported for the equipment with the one
shot type sensor.
NOTE

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7 Acquiring CEPH Images

A. Click the CEPH button.

B. Select the scanning mode under CEPH Examination. – Lateral, Full


Lateral, PA, SMV, Waters View, Carpus.

C. Select the FOV size for the specific imaging mode.

Model: OP / OS (one shot type sensor)

FOV Details
12 x 10 Full size

Region of the no interest of the rear part of the head is


9 x 10
eliminated to minimize the X-Ray exposure area.

8x8 Child

D. Exposure time

One shot type sensor (optional)

Examination Modes Scan Time (s) - Default

Lateral 0.9

PA / SMV / Waters View / Carpus 1.2

Exposure time can be adjusted by resolution of 0.1 s in the


range of 0.7 s to 1.2 s.
NOTE

Scan type sensor (optional)

Examination Modes Scan Time (s) - Default

Lateral / / PA / SMV / Waters View / Carpus 12.9

Full Lateral 16.9

For information regarding to the exposure time of each


CEPH imaging mode, refer to the section 4.3.2 CEPH mode.
NOTE

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7 Acquiring CEPH Images

E. The gender and age of the patient


is automatically selected according to
EasyDent’s patient information. Nevertheless,
ensure that this information is correct.

Age Group VATECH’s Standard


Child ≤ 12
Man
Adult ≥ 13
Woman

A Child is defined as a person who is younger than 12


years old. If child is selected, the image size and exposure
NOTE dose are automatically reduced.

F. Select X-ray intensity.

X-ray intensity (Hard, Normal, Soft) is according to the


operator's decision.
NOTE
Soft≤Normal≤Hard

G. Default values for the tube voltage (kVp)


and current (mA) will be displayed based
on the patient’s gender and X-ray intensity.
If necessary, you may manually adjust these values using the arrows to the right
of each value.

Adjustable resolution:

-- Tube voltage: ± 1 kVp


NOTE
-- Tube current: ± 1 mA

H. Click Confirm to accept the


parameters.

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7 Acquiring CEPH Images

When you click Confirm button:

■■ The Ready button will begin blinking to show that it is activate. This means
that the equipment is ready for X-Ray exposure.

■■ The CEPH sensor and the 2nd collimator enter positioning mode.

■■ The scan time and estimated DAP (Dose


Area Product) value are shown on the
main display for the intended exposure.

I. Guide the patient to the equipment. Position the patient. Refer to section 7.2
Positioning the Patient.

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7 Acquiring CEPH Images

7.2
Positioning the Patient

Follow the procedure below to prepare and position the patient for CEPH imaging.

Before Positioning the Patient

■■ Ask the patient to remove all jewelry and metallic objects, such as earrings,
hair pins, spectacles, dentures, and orthodontic appliances. These items
may cause shadow images that could impede diagnosis.

■■ It is strongly recommended that the patient wear a lead apron for protection
against any possible scatter radiation.

■■ Adjust the column height to the patient’s height using the up / down button
or switch (optional).

UP

DOWN

Light on
COLUMN RETURN SELECT CHINREST

Column Up / Down
Up / Down buttons
switch (optional)

The SELECT button is disabled in PANO and CEPH modes.


NOTE

Correct positioning is an important factor in capturing the


best possible image.
NOTE

Ensure that the nasal positioner left unfolded, before


CAUTION adjusting the ear rods in the proper direction.

Ensure that the patient is clear of all moving parts while


WARNING adjusting the height of the equipment.

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7 Acquiring CEPH Images

7.2.1
Lateral (Full Lateral)

The order and manner to take an image are equivalent for


the Lateral and Full Lateral modes, except for the exposure
area in which the full lateral covers the patient head 60 mm
NOTE
wider than the lateral.

Follow the procedure below to position the patient.


*To link to the video
A. Widen the distance between the two
manual: scan the
ear rods.
QR code with smart
phone or pad.

Porion position
reference indicator

Ear rods

Porion position reference indicator enables the operator to


easily identify the position of the porion on the image.
NOTE

B. Guide the patient to the CEPH unit.

C. Ask the patient to stand upright.


Make sure that the patient’s shoulders are
level and that their neck is relaxed.

D. Adjust the height of the unit to suit the


patient by pressing the column up / down
button or switch (optional).

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7 Acquiring CEPH Images

After adjusting the height of the column to suit the patient,


fit the ear rods along the patient’s ear canals and adjust the
CAUTION
nasal positioner.

E. The ear rods should fit properly along the patient’s ear canals. The patient’s
Frankfurt Plane should be parallel to the floor.

F. Position the nasal positioner on the patient’s Nasion point. The height of
nasal positioner can be adjusted.

G. Ask the patient to swallow saliva


and remain still until X-Ray exposure is
complete.

Frankfurt plane

H. Click the Ready button after the patient has been properly positioned. No
X-Ray will be emitted at this point. The CEPH sensor and the 2nd collimator will
enter positioning mode.

I. Proceed to section 7.3 Initiating X-Ray Exposure.

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7 Acquiring CEPH Images

7.2.2
Frontal (PA)

Follow the procedure below to correctly position the patient.

A. Turn the ear rods 90° clockwise from


their initial position as shown in the
illustration.
Nasal Poaitioner

Porion position B. Widen the distance between the two


reference indicator ear rods.

Porion position reference indicator enables the operator to


easily identify the position of the porion on the image.
NOTE

C. The nasal positioner should be flipped


to the side and upward to prevent it from
obstructing the image acquisition.

D. Guide the patient to the CEPH unit.

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7 Acquiring CEPH Images

E. Adjust the height of the unit to suit the


patient by pressing the column up / down
button or switch (optional).

After adjusting the column to the patient’s height, fit the


CAUTION ear rods along the patient’s ear canals.

F. The ear rods should fit properly along


the patient’s ear canals. The patient’s
Frankfurt Plane should be parallel to the
floor.

Frankfurt plane

G. Ask the patient to swallow saliva and remain still with his/her mouth closed
until X-Ray exposure is complete.

H. Click the Ready button after the patient has been positioned.

I. Proceed to section 7.3 Initiating X-Ray Exposure.

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7 Acquiring CEPH Images

7.2.3
SMV

Follow the procedure below to prepare and position the patient.

A. Widen the distance between the two


ear rods.

Nasal positioner B. The nasal positioner should be flipped


to the side and up to prevent it from
obstructing the image acquisition.

C. Guide the patient to the CEPH unit.

D. Adjust the height of the unit to suit the


patient by pressing the column up / down
button or switch (optional).

After adjusting the column to the patient’s height, fit the


CAUTION ear rods along the patient’s ear canals.

E. Place the ear rods along the patient’s ear canals. Make sure that the ear
rods are comfortably, yet firmly in place.

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7 Acquiring CEPH Images

F. Gently tilt the patient’s head back until


his/her Frankfurt plane is perpendicular to
the floor, as shown below.

G. Click the Ready button after the patient has been properly positioned. No
X-Ray will be emitted at this point. The CEPH sensor and the 2nd collimator will
enter positioning mode.

H Proceed to section 7.3 Initiating X-Ray Exposure.

7.2.4
Waters View

Follow the procedure below to prepare and position the patient for Waters View
mode image acquisition.

A. Widen the distance between the two


Nasal positioner ear rods.

B. The nasal positioner should be flipped


to the side and up to prevent it from
obstructing the image acquisition.

C. Guide the patient to the CEPH unit.

D. Ask the patient to stand upright facing the sensor.

Make sure that the patient’s shoulders are level and that his/her neck is relaxed.

E. Adjust the height of the unit to suit the patient by pressing the column up /
down button or switch (optional).

After adjusting the column to the patient’s height, fit the


CAUTION ear rods along the patient’s ear canals.

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7 Acquiring CEPH Images

F. Place the ear rods along the patient’s ear canals. Make sure that the ear
rods are comfortably, yet firmly, in place.

G. Ask the patient to swallow saliva and tilt


his/her neck back 35° - 40°, with the mouth
closed, until X-Ray exposure is complete.

30-40

H. Click the Ready button after the patient has been properly positioned. No
X-Ray will be emitted at this point. The CEPH sensor and the 2nd collimator will
enter positioning mode.

I. Proceed to section 7.3 Initiating X-Ray Exposure.

7.2.5
CARPUS

Attaching the CARPUS plate

A. Match the notch on the CARPUS plate


Locking bolt to the end of nasal positioner.

Nasal positioner

Fixed bolt

Ruler
Notch

CARPUS Plate

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7 Acquiring CEPH Images

B. Slide the CARPUS plate onto the nasal


positioner.

C. Slide the locking bolt on the CARPUS


plate towards the nasal positioner and turn
it to secure the CARPUS plate in place.

D. Ensure that the CARPUS plate is firmly


in place.

Positioning the Patient

A. Ask the patient to put his/her right hand


flat on the CARPUS plate. It is important to
ensure that the patient does not bend his/
her fingers.

B. Have the patient close their eyes and


remain still until scanning is complete.

Ask the patient not to block the ruler on the nasal


positioner by his / her fingers. It could deteriorate image
CAUTION
quality.

C. Click the Ready button after the patient has been properly positioned. No
X-Ray will be emitted at this point.

D. Proceed to section 7.3 Initiating X-Ray exposure.

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7 Acquiring CEPH Images

7.3
Initiating X-Ray Exposure

The X-Ray exposure method and process is the same for all CEPH modes.
The example and images below are taken from an X-Ray performed in CEPH
Lateral mode.

If a problem occurs during image acquisition, press the


red emergency stop switch to immediately stop all moving
parts and cut off the power to the equipment’s electrical
components. You may then proceed to release the patient
safely from the equipment.

To reset the emergency switch, turn it clockwise until it


pops up.

WARNING

-- Do not operate the PC during exposure. Failure to


comply with this instruction may cause the system to
malfunction.
WARNING -- The operator shall observe the X-Ray safety regulations
applicable to their area at all times during the operation
of this equipment.

If an emergency occurs during image acquisition, release


CAUTION the exposure switch to cease X-Ray emission.

A. Leave the X-Ray room and close the door. The operator must maintain
visual contact with the patient at all times during image acquisition.

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7 Acquiring CEPH Images

B. Press and hold down exposure switch until the image is acquired.

During X-Ray irradiation, ensure that:


Exposure indicator
light turns orange -- The LED lamp on top of the equipment
Orange: Exposure turns orange to indicate X-Ray emission.

-- The warning lamp outside the X-Ray


room turns on.

-- The announcement mode of either beep


or music is initiated, depending on the
set-up.

Yellow: X-Ray ON -- The radiation symbol on the upper left


corner of GUI turns yellow to indicate
X-Rays are being emitted.

The image appears in real time on the imaging GUI.

C. Click the Save button to save the acquired image. If automatic save has
been selected as a default setting, the image will be saved automatically.

D. The captured image will be automatically transferred to EasyDent. Clicking


the patient’s name in the patient list after imaging will refresh the image list for
that patient. The patient’s most recent image will appear on the far left of the
thumbnail image pane.

E. Double-click on the image to enlarge it for viewing or to check its quality.

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7 Acquiring CEPH Images

Sample images: with one shot type sensor

PA: Posterior – Anterior

FOV 12 x 10 (inches) FOV 9 x 10 (inches)


30.48x25.40 (cm) 22.86x25.40 (cm)

Lateral

Full Lateral : FOV 12 x 10 (inches) Lateral : FOV 9 x 10 (inches)


30.48x25.40 (cm) 22.86x25.40 (cm)

FOV 8 x 8 (inches) Carpus


20.32x20.32 (cm)

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7 Acquiring CEPH Images

After Image Acquisition

After acquiring the image, complete the following steps:

■■ Fold away the nasal positioner.

■■ Loosen the ear rod supports and remove them from the patient’s ears.

■■ Release the patient.

■■ Press RETURN to bring the Rotating Unit back to its initial position.

COLUMN RETURN SELECT CHINREST

RETURN button

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8
Acquiring CT Images

8.1
Setting the Exposure Parameters....................................... 108
8.2
Positioning the Patient........................................................ 112
8.3
Acquiring a SCOUT image................................................. 117
8.3.1
Starting imaging with the SCOUT feature............................118
8.3.2
SCOUT Viewer....................................................................120

8.4
Initiating X-Ray Exposure................................................... 121

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8 Acquiring CT Images

8
Acquiring CT Images
This chapter requires all preparatory steps outlined in Chapter 5 to have
already been completed. If you have not completed these steps, return to
Chapter 5 and complete the process described there before performing the
tasks outlined in this chapter.

8.1
Setting the Exposure Parameters

Perform the following procedures to set capture parameters for the specific
patient and capture mode (For more details, refer to section 4.3.3 CBCT
Mode).

Xmaru0712CF sensor

Xmaru1215CF Plus sensor

The FOV size is determined by the CT sensor attached on


the equipment.
NOTE

A. Click the CBCT button. The rotating unit will move to position for CT
scanning.

B. Select the FOV size for the CT.

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8 Acquiring CT Images

C. Select the ROI to be captured under VERTICAL POSITION and


HORIZONTAL POSITION.

Once you have selected an FOV size and ROI (Region of Interest) to capture,
the area of the selected FOV and position of ROI will be viewed on the
guidance image as shown below. For the FOV 50 X 50, you may select a
specific tooth position to be captured on the full arch guidance image.

The following shows a few examples about guidance image.

Mode FOV (mm) ROI

120 X 90 Mn - Center

80 X 80 Mn - Center

80 X 50 Mn - Right

Mn / Left Central
50 X 50
Incisor

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8 Acquiring CT Images

D. Select the image acquisition speed


D
under High (24 s) or Standard (15 s).

High: Higher quality image acquisition mode than Standard


mode.
NOTE

E. Select either Standard or Application mode for the voxel resolution.

F. If Metal Artifact Reduction is necessary, click Apply under Metal Artifact


Reduction. Metal Artifact Reduction reduces the appearance of metal in imaging.
This function is most effective when there are fewer than 3 metal artifacts.

The MAR (Metal Artifact Reduction) function doubles image


reconstruction time.
NOTE

I G H

G. Gender selection will be made automatically according to the patient


information registered in EasyDent. Nevertheless, ensure that this information
is correct.

Age Group VATECH’s Standard


Child ≤ 12
Man
Adult ≥ 13
Woman

H. Select the patient’s bone density type.

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8 Acquiring CT Images

Bone density (Hard, Normal, or Soft) is determined based


on the circumference of the patient’s head.
NOTE
Soft≤Normal≤Hard

I. A default tube voltage (kVp) and current (mA) value will be displayed based
on the patient’s gender and bone density. If necessary, you can perform
manual adjustments by clicking the arrows to the right of each number.

Adjustable resolution:
-- Tube voltage: ± 1 kVp
NOTE -- Tube current: ± 0.1 mA

J. Click Confirm to accept these


parameters.

Please wait for a moment, while the rotating unit moves to


its initial scanning position.
NOTE

When you click Confirm button:

■■ The Confirm button turns to the SCOUT


and then the Ready button is enabled
and flashes

This means that the equipment is ready for X-Ray exposure.

SCOUT capture is featured in FOV size 80 X 50 and 50 X 50.

In case of abnormal patient’s arch, the chinrest height


adjustment through the SCOUT feature enables the user to
acquire better image. When the SCOUT image needs to be
acquired, position the patient first, followed by clicking the
NOTE
SCOUT button.

For details about imaging in the SCOUT mode, refer to the


section 8.3 Acquiring a Scout image.

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

■■ The chin support will adjust itself according to the mode selected.

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8 Acquiring CT Images

■■ Three laser beams (CT horizontal (X), Mid-sagittal (Y) and CT vertical (Z))
will activate to facilitate patient alignment. These beams will disappear after
20 minutes or if the Ready button is clicked.

The laser beams On / Off button are on the upper right of


the GUI:
NOTE

■■ The scan time and estimated DAP (Dose


Area Product) value are shown on the
main display for the intended exposure.

K. Guide the patient to the equipment. Position the patient. Refer to section 8.2
Positioning the Patient.

8.2 Positioning the Patient


Follow the procedure outlined below to properly position the patient for CT
scanning.

Before Positioning the Patient

■■ Ask the patient to remove all jewelry and metallic objects, such as earrings,
hair pins, spectacles, dentures, and orthodontic appliances. These items
can cause shadow images which could obstruct diagnosis.

■■ It is strongly recommended that the patient wear a lead apron to protect


against scatter radiation.

■■ Adjust the column height to the patient’s height using the up / down button
or switch (optional).

UP

DOWN

Light on
COLUMN RETURN SELECT CHINREST

Column Up / Down
Up / Down buttons
switch (optional)

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In general, imaging is performed with the patient in an


upright position. However, a stool may be used for imaging
patients with special circumstances. If a stool is used,
NOTE ensure that the beams and movement of unit are not
obstructed by the stool.

Correct positioning is an important factor in capturing the


best possible image. Proper positioning will reduce the
NOTE appearance of the cervical spine in the image.

Be careful not to project the laser beams directly into the


patient’s eyes as this could severely damage the patient’s
WARNING
vision.

Positioning the Patient

A. Insert the normal chin support and bite


block into the chin support receptacle on
Hygiene cover the equipment.
B. Place a hygienic cover over the bite
block.

Bite block

* For patients who lack teeth, use the


Chin support: Normal edentulous chin support. Refer to section
3.3.3 Components and Positioning
Accessories.

The hygiene cover for the bite block is intended for single
use only. Always replace the hygiene cover for each new
WARNING
patient.

Disinfect the chin support and bite block using an alcohol-


based cleaning solution and wipe away all residue with dry
CAUTION
cloth before each new patient.

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8 Acquiring CT Images

C. Loosen the temple supports by turning


the Temple Support Wheel at the rear of
the patient support table.

Temple support wheel

D. Guide the patient —facing the chin support — to the equipment.

E. Adjust the height of the column using the column up / down button or switch
(optional) until the patient’s chin rests comfortably on the Chinrest.

F. Ask the patient to:

■■ Stand upright

■■ Firmly grip the handles on both sides of


the unit

■■ Lean his/her chest lightly against the


equipment

■■ Position his/her feet slightly forward

Ensure that the patient’s shoulders remain


level and that his/her neck is relaxed.
The cervical spine should be straight and
upright.

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G. Have the patient:

■■ Bite the bite block along its grooves


using his/her upper and lower incisors

■■ Close his/her lips

■■ Keep his/her tongue pressed against


his/her palate

■■ Close his/her eyes

The patient’s occlusion line should be


parallel to the floor.
Ask the patient to remain still until
scanning is complete.

To acquire the best image possible, ask the patient not to:

-- Breathe or swallow saliva during image acquisition


NOTE
-- Move during image acquisition

Aligning the Laser Beams

Three laser beams - CT horizontal (X), Mid-sagittal (Y)


and CT vertical (Z) - will be activated to facilitate patient
positioning. The beams will disappear after 20 minutes or if
the Ready button is clicked.
NOTE
To turn the laser beams on or off, click the icon on the
imaging GUI.

Be careful not to project the laser beams directly into the


patient’s eyes as this could severely damage the patient’s
WARNING
vision.

The 3D CT image centers the FOV on the intersection of the three laser beams
(CT horizontal (X), Mid-sagittal (Y) and CT vertical (Z)).

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Mid-sagittal plane
laser beam (Y)

CT horizontal laser
beam (X)

CT vertical laser
beam (Z)

(FOV 80 X 50)

A. CT horizontal laser beam (X): Position the CT horizontal laser beam at


the center of the FOV area. If necessary, the CT horizontal laser beam can
be manually adjusted by pressing the Chinrest up / down button to make fine
adjustments (①→ ②→ ③).

1. Touch the SELECT button to switch


COLUMN RETURN SELECT CHINREST
the mode (COLUMN → CHINREST).
2. Ensure that the CHINREST LED light
is On.
③ ① ②
3. Touch the Up / Down buttons.

B. Mid-sagittal plane laser beam (Y): Position the Mid-sagittal plane laser
beam at the center of the FOV area.

C. CT vertical laser beam (Z): Position the CT vertical laser beam at the
center of FOV from the patient’s lateral.

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8 Acquiring CT Images

Completing Patient Positioning

A. After confirming patient positioning and beam alignment, adjust the temple
supports to fit snugly on both sides of the patient’s head using the temple
support wheel. The temple support wheel is located at the front of the patient
support rest.

B. Click the Ready button on the GUI after


the patient has been properly positioned.
No X-Ray will be emitted at this point. The
rotating unit will then move to position for
imaging.

If, for the FOV size of 80 x 50 and 50 x 50, the SCOUT image is to be acquired,
click the SCOUT button.

SCOUT capture is featured in FOV size 80 x 50 and 50 X 50.

In case of abnormal patient’s arch, the chinrest height


adjustment through the SCOUT feature enables the user
NOTE to acquire better image. For details about imaging in the
SCOUT mode, refer to the ‘section 8.3 Acquiring a Scout
image’.

C. Proceed to section 8.4 Initiating X-Ray Exposure.

But if the SCOUT feature is selected, move to the following section 8.3
Acquiring a SCOUT image, and then the section 8.4 Initiating X-Ray
Exposure.

8.3 Acquiring a SCOUT image


In general, the imaging trajectory is predefined along the normal arch shape.
In case of abnormal patient’s arch, the chinrest height adjustment through the
SCOUT feature enables the user to acquire better image.

The SCOUT feature is incorporated in the CT imaging mode


with the FOV 80 x 50 and 50 X 50.

NOTE The procedures for the SCOUT image acquisition are the
same for both FOVs.

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8 Acquiring CT Images

8.3.1 Starting imaging with the SCOUT feature

SCOUT Imaging Flow Chart

The patient
Start positioned

Parameters set SCOUT image NO


preferred ?
YES
[ CONFIRM ]
button clicked [ SCOUT ] [ READY ]
button clicked button clicked

Imaging CT image acquired


in the SCOUT mode

The end
The patient cleared
from the equipment

Chinrest height
readjusted

Imaging and Coordinate compensation

The parameter setting for exposure and patient positioning are the same as
those described in the section 8.1 and 8.2. For the SCOUT feature-specific
imaging, do take the steps in the following manner.

A. When the parameter setting and patient position are done, click the SCOUT
button.

B. Press and hold down the exposure switch to acquire the SCOUT image.

C. Guide the patient out of the equipment.

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8 Acquiring CT Images

Always perform the chinrest coordinate adjustment after


the patient is cleared from the equipment.

Failure to do so could result in the physical injury, due to


WARNING the vertical movement of chinrest to new position reflected
after the ‘CONFIRM’ button on the SCOUT Viewer is
clicked.

D. Once the imaging has been completed, the resulting image with the SCOUT
feature appears.

For details about the SCOUT Viewer, refer to the section


8.3.2 SCOUT viewer.
NOTE

The green-colored horizontal line appears on the SCOUT image, when the left
button of the mouse is clicked at the point which you want to move to the center
of the image (Ex: 50 x 50).

[Maxillary is compensated] [The teeth root of Mandible is


compensated]

To adjust the image contrast for making the compensating


point distinct, you may adjust the black and white level
NOTE with the Adjust control on the right of image.

<Ex) White level: 50→306>

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8 Acquiring CT Images

<Ex) Black level: 50→306>

To adjust the image contrast for making the compensating


point distinct, you may adjust the black and white level
NOTE with the Adjust control on the right of image.

E. Upon clicking the CONFIRM button, the SCOUT view screen closed, and the
chinrest moves to newly compensated position vertically.

F. Guide the patient into the equipment again and position the patient.

G. Click the READY button from the GUI.

H. Press and hold down the exposure switch to acquire the CT image: refer to
the section 8.4 Initiating X-Ray Exposure.

If the acquired image is unsatisfactory, you may repeat the


steps above with a different coordinate.
NOTE

8.3.2
SCOUT Viewer
B

C D

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8 Acquiring CT Images

A. Raw View Window:

-- Displays the acquired image and the guideline.

-- The green-colored horizontal line appears when the mouse clicked at the
point to be moved to on the image.

B. Adjust

-- White: make the current white level whiter.

-- Black: make the current dark level darker.

C. Initialize : When clicked, returns to the initial state of the completion of the
SCOUT imaging.

D. CONFIRM : When clicked, the SCOUT view screen closed and the chinrest
moves to newly compensated position vertically.

8.4
Initiating X-Ray Exposure

Perform the following process to acquire an image in CT mode.

If a problem occurs during image acquisition, press the


red emergency stop switch to immediately stop all moving
parts and cut off all power to the equipment’s electrical
components. You may then safely release the patient from
the equipment.

To reset this switch, turn it clockwise until it pops up.

WARNING

Do not operate the PC during exposure. Failure to


comply with this instruction may cause the system to
WARNING
malfunction.

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8 Acquiring CT Images

The operator shall observe the X-Ray safety regulations


applicable to their area at all times during the operation of
WARNING
this equipment.

A. Leave the X-Ray room and close the door. The operator must visually
monitor the patient at all times during image acquisition.

B. Press and hold down the exposure switch until image acquisition is
complete.

During X-Ray irradiation, ensure that

■■ The LED lamp on top of the equipment


Exposure indicator
turns orange to indicate X-Ray emission.
light turns orange
Orange: Exposure ■■ The warning lamp outside the X-Ray
room turns on.

■■ The announcement mode of either beep


or music is initiated, depending on the
set-up.

■■ The radiation symbol on the upper left


corner of GUI turns yellow to indicate
X-Rays are being emitted.
Yellow: X-Ray ON

The image appears in real time on the imaging GUI.

If an emergency occurs during image acquisition, release


CAUTION the exposure switch to cease X-Ray emission.

C. The captured image is automatically reconstructed and converted into a


DICOM file. Click the Save button to store the file in the patient database (If
automatic save is selected in the program settings, the image will be saved
automatically).

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8 Acquiring CT Images

If automatic image reconstruction fails, the image must


be reconstructed manually by clicking the reconstruction
button ( ) in the upper right corner of the screen.

Select modality and click Search → Reconstruction.

NOTE

Once acquisition is complete, the image is automatically transferred to


EasyDent.

D. Clicking the patient’s name in EasyDent’s patient list will refresh the image
list for that patient. The patient’s most recent image will appear on the far left of
the thumbnail image pane, as shown below.

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8 Acquiring CT Images

E. Double-click the CT image on the thumbnail to open Ez3D plus, the system’s
3D viewing program. Ez3D plus facilitates prompt analysis and diagnosis of the
patient’s 3D image.

After Image Acquisition

Perform the following tasks after acquiring a CT image:

■■ Loosen the temple supports and release the patient.

■■ Remove the hygiene barrier from the bite block.

■■ Press RETURN to bring the rotating unit back to its initial position.

COLUMN RETURN SELECT CHINREST

RETURN button

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9
Troubleshooting

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9 Troubleshooting

9
Troubleshooting
If a problem occurs while operating this equipment, perform the corresponding
troubleshooting measure outlined in the table below. If the problem persists,
please contact our customer support staffs.

- If the device is not moving


Cause Solution
Power failure Check the equipment’s power supply.
Wait until the equipment has initialized and then try
Initialization status
again.
Control PC Check the connection status of Serial Port (RS232)
connection failure which connects the PC to the equipment.

- If the exposure switch is not functioning


Cause Solution
Check whether it is ready for capturing at the imaging
Ready status
program.

- If imaging cannot be performed


Cause Solution
Wait until the equipment has initialized and then
Initialization status try again. If this problem persists, restart the
equipment.

- If the laser beam has shut off and patient alignment cannot be
performed
Cause Solution
The time allotted for
Press the laser beam button to turn on the lasers
patient alignment
and then carry out patient alignment.
has expired

Do not allow any liquids in the vicinity of the machine as


moisture may cause extensive damage to this equipment’s
CAUTION
electrical components.

If a problem occurs during image acquisition, press the


red emergency stop switch located on the handle frame
to immediately stop all moving parts and cut off all power
WARNING
to the equipment’s electrical components. You may then
safely release the patient from the equipment.

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10
Cleaning and Maintenance

10.1
Cleaning............................................................................. 128
10.2
Maintenance....................................................................... 129

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10 Cleaning and Maintenance

10
Cleaning and Maintenance
Always turn off the power to the equipment and disconnect
WARNING it from the power outlet before cleaning.

10.1
Cleaning

■■ Thoroughly clean areas of the equipment which come into contact with the
patient, such as the handle frame, chin support and bite block.

■■ Do not use spray cleaners or solvents as they could enter the equipment
and damage to the electrical components or cause a fire.

■■ Do not use abrasive liquids such as acetone, gas, or oil, which could
corrode the surface of the equipment.

■■ Do not use cleaning products which contain silicon as they could potentially
damage the equipment’s electrical components.

The following table summarizes the standard cleaning procedures to be


performed by the operator.

Accessories Cleaning Process

Clean the bite blocks using an alcohol-based


Bite block disinfectant and dry thoroughly with a soft dry
cloth, before each patient is X-Rayed.

Clean the temple support using an alcohol-based


Temple support disinfectant and dry thoroughly with a soft dry
cloth before each patient is X-Rayed.

Clean the chin support using an alcohol-based


Chin support
disinfectant before each patient is X-Rayed.

All components that


Clean components using an alcohol-based
come into contact with
disinfectant before each patient is X-Rayed.
the patient or operator

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10 Cleaning and Maintenance

Accessories Cleaning Process

Computer and Follow the manufacturers’ instructions found in


peripherals the accompanying manuals.

Wipe the unit with a dry cloth at the end of each


day.
Outer covers of
equipment Do not use cleaning agents in
aerosol or spray form directly on the
CAUTION
surface of the equipment.

10.2
Maintenance

VATECH requires periodic constancy tests to ensure image quality and the
safety for the patient and operator.

Only VATECH authorized technicians can perform inspection and service of


this equipment. For the technical assistance, contact VATECH service center or
your local VATECH representative.

Regular Maintenance

There are no user serviceable parts inside this equipment.


If servicing is required, please contact the VATECH service
NOTE center or your local VATECH representative.

-- Always turn off the equipment before performing any


maintenance.
-- Never remove equipment covers. There are no repairable
parts inside.
-- The only part that can be replaced by the user is the
WARNING
input fuses, which must comply with the manufacturer’s
specification.
-- In order to safeguard against fire, only replace fuses with
fuses of the same type and range.

■■ Do not use force to unplug cables.

■■ Do not expose the equipment or components in an area which is susceptible


to water or humidity.

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10 Cleaning and Maintenance

■■ Do not expose the equipment in an area which subject to temperature


extremes, poor ventilation, direct sun light, dust, salt, etc.

■■ Keep all detachable components well organized and clean.

■■ Make sure that the equipment is well grounded.

■■ Never try to modify this equipment, including the wires or cables. Modifying
this equipment may damage it beyond repair.

Maintenance Task Checklist

Maintenance
Maintenance Tasks
period
Before operation, ensure that the equipment is clean and
ready for use. Make sure that all parts which come into Daily
contact with the patient have been disinfected and cleaned.
After using the equipment, make sure that the main power
Daily
switch has been turned off.
Ensure that the equipment is firmly plugged into a dedicated
Daily
power source.
Ensure that the plug and power cord are not hot.. Daily

Confirm that the orange (exposure) indicator lamp turns


on when the exposure switch is pressed. Ensure that the
Daily
orange (exposure) indicator light remains on for the entire
duration of the exposure.
Ensure that the power cable is not kinked, broken, exposed
Weekly
and that it is free of all other defects.
Confirm that activating the emergency stop switch ceases
the unit’s operation. Pressing the emergency stop switch Weekly
should stop all equipment movements and X-Ray emission.
Ensure that all visible labels are intact and legible. Monthly
Check for possible wear or damage to the exposure switch
Monthly
cable.
Confirm that the audio message is audible throughout the
Monthly
duration of the exposure.

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11
Disposing of the Unit

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11 Disposing of the Unit

11
Disposing of the Unit
In order to reduce environmental contamination, this equipment is designed
to be as safe as possible to use and dispose of. Many components of this
equipment, except for some like X-Ray tube, are environment-friendly and can
be recycled.

All parts and components which contain hazardous materials must be disposed
in accordance with disposal regulations (IEC 60601-1 6.8.2 j).

Hazardous
Waste waste;
Part Material Recyclable Disposal Needs
Site Separate
Collection
Aluminum
Frame and covers ●
and plastics
Motors ●
Circuit boards ●
Copper ●
Cables and
Steel ●
transformer
Oil ●
Wood ●
Packing Cardboard ●
Paper ●
X-Ray tube ●
Sensor head Return the sensor head to VATECH
Other parts ●

Please observe all regulations relevant to the disposal of


waste in your country.
NOTE

This dental equipment shall not be disposed of as domestic


WARNING garbage materials.

Please clean, disinfect and sterilize the equipment before

IMPORTANT dissembling it and disposing of its parts.

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12
Technical Specifications

12.1
Mechanical Specifications.................................................. 134
12.2
X-Ray Generator................................................................ 137
12.3
Electrical Specifications...................................................... 142
12.4
Environmental Specifications............................................. 142

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12 Technical Specifications

12
Technical Specifications

12.1
Mechanical Specifications

Image Magnification

Mode FDD (mm) FOD (mm) ODD (mm) Magnification

PANO 585.9 439.7 146.2 1.33 constant

CEPH 1,745 1,524 221 1.14 constant

CT 642.3 409.7 232.6 1.56 constant


FDD : Focal Spot to Detector Distance
FOD : Focal Spot to Object Distance
ODD : Object to Detector Distance (ODD = FDD - FOD)
Magnification = FDD / FOD

Dimension

Without Cephalometric Unit [Unit: mm (Inches)]

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12 Technical Specifications

With Cephalometric Unit - Scan Type

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12 Technical Specifications

With Cephalometric Unit- One Shot Type

2,345 mm, represents the total height of the equipment with


the column extended fully.
NOTE

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12 Technical Specifications

Item Description
Without CEPH 120 (264.5 ibs)
unit With base: 167 (368.2 ibs)
Weight (kg)
150 (331 ibs)
With CEPH unit
With base: 197 (434.3 ibs)
Total Height (mm) Max. 2,340 (92.13 in.)

Vertical column movement (mm) Max. 700 (Max. 27.56 in.)

Without 1,115 (L) x 1,290(W) x 2,340 (H) mm


CEPH unit 43.9 (L) x 50.8 (W) x 92.13(H) inch

Length x Width With CEPH unit 1,930 (L) x 1,290 (W) x 2,340 (H) mm
x Height (mm) (Scan Type) 76 (L) x 50.8 (W) x 92.13(H) inch.

With CEPH unit 1,930 (L) x 1,290 (W) x 2,340 (H) mm


(One shot Type) 76 (L) x 50.8 (W) x 92.13 (H) inch.

Type of installation Base Stand / Wall Mount

* Column Height Limiting Function: Max. 2,340 - Min. 1,625 (Adjustable in 10 mm)

12.2
X-Ray Generator

X-Ray Generator

Item Description

Model HDG-07B10T2
Rated output power 0.9 kW
Type 40 kHz Inverter Type

Normal/ kVp 50 - 90 kV
High voltage Pulse mA 4 - 10 mA
generator
Automatically controlled / Protect
Cooling
≥ 60 ℃
Total filtration 2.8 mm Al eq. (IEC60522)
Manufacturer TOSHIBA
Model D- 052SB (Stationary Anode type)
X-Ray tube
Focal spot size 0.5 mm (IEC60336)
Target angle 5°

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12 Technical Specifications

Item Description

Target material Tungsten

Inherent Filtration At least 0.8 mm Al eq. at 50 kV

X- ray Coverage 95 x 380 mm at SID 550 mm


X-Ray Tube
Anode Heat Content 35 kJ

1: 60 or more (Exposure time :


Duty Cycle interval time)

XXXX
Size XXX XX XX XX XX XXXX
(mm)
S/N
Inverter F/W Weekly Yearly
Model Tube serial
ver. ver. code code

Maximum Rating Charts


DC (Center Grounded)

Constant potential high-voltage generator


Nominal Focus Spot Value: 0.5
25

80kV 70kV
60kV

20 90kV 50kV
TUBE CURRENT [mA]

100kV

15

10

5
1 2 3 5 7 10 20

EXPOSURE TIME [s]

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12 Technical Specifications

Emission & Filament Characteristics

Constant potential high-voltage generator


Nominal Focus Spot Value: 0.5

25 6

80kV

20 5
100kV

FILAMENT VOLTAGE [V]


TUBE CURRENT [mA]

15 Ef 4

10 3

5 50kV 2

0 1
2.9 3.0 3.1 3.2 3.3 3.4 3.5
FILAMENT CURRENT [A]

Anode Thermal Characteristics

35
W
5
31
30 W
225
175 W
25
HEAT STORAGE (kJ)

20

15

10

COOLING
5
HEATING
0
0 2 4 6 8 10
TIME (min)

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12 Technical Specifications

Indication of focal spot

FOCAL SPOT

X-Ray tube assembly heating / cooling curve

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12 Technical Specifications

Detector Specifications

Description
Item
PANO CEPH (optional)
Model Xmaru1501CF Xmaru2301CF 1210SGA
Amorphous silicon TFT
Detector type CMOS photodiode array
with scintillator
Pixel size (㎛) 100 100 127
Active area
6 x 150.4 5.9 x 230.4 264 x 325
(mm)
Frame rate 300 fps 200 fps 240 fph
A/D (bits) 14
Sensor size
175.4 x 86 x 21.6 251.2 x 69 x 27.1 402 x 364 x 32
(mm)

Description
Item
CT (optional)
Model Xmaru1215CF Plus Xmaru0712CF
Detector type CMOS photodiode array
140 (Single operation)
Pixel size (㎛) 140
280 (2 x 2 binning)
Active area (mm) 143.36 x 117.6 71.68 x 117.46
30 (Single operation)
Frame rate (fps) 30
50 (2 x 2 binning)
A/D (bits) 14
Sensor size (mm) 212.5 x 150 x 24.7 213.2 x 159 x 24.8

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12 Technical Specifications

12.3
Electrical Specifications

Item Description

AC 100 ~ 120 / 200 ~ 240 V

-- AC 100 V (Japan)
-- AC 110 V (Taiwan)
Power supply voltage -- AC 120 V (USA / Canada)
-- AC 220 V (China)
-- AC 110 V / 230 V (European Union
or the rest countries)
-- AC 240 V (Australia)

Frequency 50 / 60 Hz (Single)

Power rating Max.2.2 kVA

■■ The input line voltage depends on the local electrical distribution system.

■■ Allowable input voltage fluctuation requirement: ±10 %.

12.4
Environmental Specifications

Item Description

Temperature 10 ~ 35 ℃

During operating Relative humidity 30 ~ 75 %

Atmospheric pressure 860 ~ 1060 hPa

Temperature -10 ~ 50 ℃

10 ~ 75 %
Transport and storage Relative humidity
non condensing

Atmospheric pressure 860 ~ 1060 hPa

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Appendices

1
Recommended X-Ray Exposure Table........ 144
1.1
PANO.................................................................................. 144
1.2
CEPH.................................................................................. 144
1.3
CBCT.................................................................................. 145

2
X-Ray Dose Data............................................ 146
2.1
DAP Table........................................................................... 146
2.2
CTDI................................................................................... 147
2.3
X-Ray Scatter Dose ........................................................... 148

3. 
Electromagnetic Compatibility (EMC)
Information .................................................... 150

4. 
Acquiring image for the pediatric dental
patient............................................................. 154
4.1
Age group: classification table............................................ 154
4.2
Positioning the pediatric dental patient............................... 154
4.3
Setting exposure values to the age group.......................... 155
4.4 
The references pertinent to the potential risks for
the pediatric patients......................................................... 155

5
Abbreviations................................................ 158

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Appendices

1 Recommended X-Ray Exposure Table

1.1
PANO

Gender / Figure Hard (kVp / mA) Normal (kVp / mA) Soft (kVp / mA)
Man 76 / 10 75 / 10 74 / 10

Woman 75 / 10 74 / 10 73 / 10

Child 68 / 8.0 67 / 8.0 66 / 8.0

1.2
CEPH

Lateral

Gender /
Hard (kVp / mA) Normal (kVp / mA) Soft (kVp / mA)
Figure
Sensor
One shot Scan One shot Scan One shot Scan
Type

Man 90 / 10 86 / 10 90 / 10 85 / 10 89 / 10 84 / 10

Woman 90 / 10 85 / 10 90 / 10 84 / 10 89 / 10 83 / 10

Child 86 / 10 81 / 10 85 / 10 80 / 10 85 / 10 80 / 9

PA / SMV / Waters View

Gender /
Hard (kVp / mA) Normal (kVp / mA) Soft (kVp / mA)
Figure
Sensor
One shot Scan One shot Scan One shot Scan
Type
Man 90 / 10 88 / 10 90 / 10 87 / 10 89 / 10 86 / 10

Woman 90 / 10 87 / 10 90 / 10 86 / 10 89 / 10 85 / 10

Child 86 / 10 83 / 10 85 / 10 82 / 10 84 / 10 81 / 10

Carpus

Normal (kVp /
Gender / Figure Hard (kVp / mA) Soft (kVp / mA)
mA)
Man / Woman / Child 60 / 6.0 60 / 5.0 60 / 4.0

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Appendices

1.3
CBCT

Xmaru0712CF (optional)

Gender / Figure Hard (kVp / mA) Normal (kVp / mA) Soft (kVp / mA)

Man 90 / 5.3 89 / 5.3 88 / 5.3

Woman 90 / 5.0 89 / 5.0 88 / 5.0

Child 86 / 5.0 85 / 5.0 84 / 5.0

Xmaru1215CF plus (optional)

Gender / Figure Hard (kVp / mA) Normal (kVp / mA) Soft (kVp / mA)

Man 90 / 5.5 89 / 5.5 88 / 5.5

Woman 90 / 5.2 89 / 5.2 88 / 5.2

Child 86 / 5.2 85 / 5.2 84 / 5.2

-- Maximally allowed tube voltage / current: kVp ± 10 % /


mA ± 20 % according to IEC60601-2-7.
--
-- Due to image optimization performed prior to shipping,
NOTE
equipment data may differ slightly from those specified
in the table.

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Appendices

2
X-Ray Dose Data
The X-Ray dose data is extracted from the X-Ray Dose Test Report for the
PaX-i3D. X-Ray Dose Test Report for the PaX-i3D maintains dosemetric
evaluation of VATECH dental diagnostic system meets all requirements
specified in the IEC Collateral Standard. To limit unnecessary exposure to the
patient, operator or other staff, the PaX-i3D is designed to comply with IEC
60601-1-3 Part 1 General Requirements for Safety.

Test Condition
Brand Name (Model) PaX-i3D (PHT-6500)
PANO: Xmaru1501CF
Sensor CEPH: Xmaru2301CF
CT: Xmaru1215CF Plus
X-Ray generator HDG-07B10T2

2.1
DAP Table

Test Equipment
Instrument Manufacturer Model S/N
Dose Meter Piranha 255 CB2-06090029

Mode Tested: PANO HD / Normal / Standard 13.5 s


mA 4 6 8
kVp [mGy] [mGyㆍcm2] [mGy] [mGyㆍcm2] [mGy] [mGyㆍcm2]

60 3.48 25.1 5.00 36.0 6.49 46.7


70 4.48 32.3 6.54 47.1 8.32 59.9
80 5.93 42.7 8.54 61.5 10.61 76.4
90 7.27 52.3 10.46 75.3 13.02 93.7

Mode Tested: CEPH PA, 12.9 s


mA 4 6 8
kVp [mGy] [mGyㆍcm2] [mGy] [mGyㆍcm2] [mGy] [mGyㆍcm2]

60 0.27 3.2 0.39 4.7 0.50 6.1


70 0.36 4.4 0.53 6.4 0.71 8.6
80 0.47 5.7 0.69 8.4 0.92 11.1
90 0.59 7.1 0.86 10.4 1.15 13.9

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Appendices

Mode Tested: CT Adult FOV 120 x 90, 15 s


mA 4 6 8

kVp [mGy] [mGyㆍcm2] [mGy] [mGyㆍcm2] [mGy] [mGyㆍcm2]

60 1.18 196.7 1.79 296.8 2.42 401.7


70 1.79 297.5 2.75 456.5 3.63 602.3
80 2.49 414.0 3.87 643.2 5.05 838.5
90 3.28 544.6 5.08 844.0 6.64 1102.1

2.2
CTDI (CT Dose Index)

Testing Equipment

Instrument Manufacturer Model S/N

Dose Meter Unfors XI Base Unit 163288

Test Phantom

PMMA
Radcal 20CT6 16 cm
Head Phantom

Test Condition: FOV 120 x 90, 15 s, 90 kVp


CTDI100 [mGy]
[mA]
4 6 8
Location
Center 292 450 600
0° 268 414 556
90° 240 399 534
180° 316 482 643
270° 272 418 556

Testing Conditions: FOV 80 x 80, 15 s, 90 kVp


CTDIW [mGy] DLP [mGyㆍcm]
[mA]
4 6 8
Category
CTDIW 2.89 4.49 6.00
DLP 24.53 38.20 51.00

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Appendices

2.3
X-Ray Scatter Dose

Test Equipment Information

Manufacturer Model S/N

Dose Meter Victoreen 660 101114 / 101377

PANO Mode

Test Condition

Mode Tested PANO UHD

Distance from focal point [m] 1

Applied Tube Voltage Peak [kVp] 90

Applied Tube Current [mA] 10

Mode PANO UHD, 20.2 s [mR / hr]

1m 1.5 m 2m
Direction [°] (3.3 ft) (4.9 ft) (6.6 ft)

0 54.5 28.9 19.8

45 98.7 38.2 20.2

90 97.6 35.2 19.3

135 93.7 35.7 22.8

180 93.7 38.3 21.9

225 81.6 41.2 19.8

270 61.7 27.9 8.2

315 54.2 29.0 19.2

CT Mode

Test Condition

Tested Mode FOV 120 x 90, 15 s

Distance from focal point [m] 1

Applied Tube Voltage Peak [kVp] 90

Applied Tube Current [mA] 10

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Appendices

Mode FOV 120 x 90, 15 s [mR/hr]

1m 1.5 m 2m
Direction [°] (3.3 ft) (4.9 ft) (6.6 ft)

0 38.9 26.6 17.0

45 268 110 72.5

90 204 105 97.4

135 321 137 99.9

180 277 97.9 76.1

225 412 96.6 84.3

270 290 118 102

315 304 176 93.5

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Appendices

3. 
Electromagnetic Compatibility
(EMC) Information
Guidance and manufacturer’s declaration - electromagnetic emissions.

The model PaX-i3D(PHT-6500) is intended for use in the electromagnetic


environment specified below. The customer or the user of the model PaX-
i3D(PHT-6500) should assure that it is used in such an environment.

Electromagnetic environment -
Emissions test Compliance
guidance

The model PaX-i3D(PHT-6500)


uses RF energy only for its
RF emissions internal function. Therefore, its RF
Group 1
CISPR 11 emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.

Class A (The The model PaX-i3D(PHT-6500)


model PaX- must be used only in a shielded
RF emissions i3D(PHT-6500) location with a minimum RF
CISPR 11 in combination shielding effectiveness and, for
with the shielded each cable that exits the shielded
location) location, a minimum RF filter
attenuation of 20 dB from 30
Harmonic
MHz to 230 MHz, 20 dB from 230
emissions IEC Not applicable
MHz to 1 GHz. The model PaX-
61000-3-2
i3D(PHT-6500) , when installed in
such a shielded location, is suitable
for use in all establishments other
Voltage
than domestic, and may be used in
fluctuations
domestic establishments and those
/ flicker Not applicable
directly connected to the public
emissions IEC
low-voltage power supply network
61000-3-3
that supplies buildings used for
domestic purposes.

NOTE) It is essential that the actual RF shielding effectiveness and filter


attenuation of the shielded location be verified to ensure that they meet or
exceed the specified minimum values.

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Appendices

Guidance and manufacturer’s declaration - electromagnetic immunity

The model PaX-i3D(PHT-6500) is intended for use in the electromagnetic


environment specified below. The customer or the user of the model PaX-
i3D(PHT-6500) should assure that it is used in such an environment.

Emissions Compliance Electromagnetic


Compliance
test level environment -guidance

Floors should be wood,


Electrostatic
concrete or ceramic tile.
discharge ± 6 k V ± 6 k V
If floors are covered with
(ESD) Contact ±8 Contact ±8
synthetic material, the
IEC 61000- kV air kV air
relative humidity should be
4-2
at least 30 %.

Electrical
±2 kV for ±2 kV for
f a s t Mains power quality
power supply power supply
transient/ should be that of a typical
lines ±1 kV lines ±1 kV
burst commercial or hospital
for input/ for input/
IEC 61000- environment.
output lines output lines
4-4

±1 kV line(s) ±1 kV line(s) Mains power quality


Surge
to line(s) ±2 to line(s) ±2 should be that of a typical
IEC 61000-
kV line(s) to kV line(s) to commercial or hospital
4-5
earth earth environment.

< 5 % UT < 5 % UT
Mains power quality
(> 95 % dip (> 95 % dip
should be that of a
in UT) for in UT) for
Voltage typical commercial or
0.5cycle 40 0.5cycle 40
dips, short hospital environment.
% U T (60 % % U T (60 %
interruptions If the user of the model
dip in UT ) dip in UT )
and voltage PaX-i3D(PHT-6500)
for 5 cycle, for 5 cycle,
variations image intensifier requires
6 cycle 70 6 cycle 70
on power continued operation during
% U T (30 % % U T (30 %
supply input power mains interruptions,
dip in UT) for dip in UT) for
lines it is recommended that the
25 cycle, 30 25 cycle, 30
IEC 61000- model PaX-i3D(PHT-6500)
cycle <5 % cycle <5 %
4-11 be powered from an
U T (< 95 % U T (< 95 %
uninterruptible power
dip in UT ) for dip in UT ) for
supply.
5s 5s

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Appendices

P o w e r 3 A/m 3 A/m Power frequency magnetic


frequency fields should be at levels
(50/60 Hz) characteristic of a typical
magnetic location in a typical
field commercial or hospital
IEC 61000- environment.
4-8

NOTE) UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration - electromagnetic immunity

The model PaX-i3D(PHT-6500) is intended for use in the electromagnetic


environment specified below. The customer or the user of the model PaX-
i3D(PHT-6500) should assure that it is used in such an electromagnetic
environment

Immunity IEC 60601 Compliance Electromagnetic


test test level level environment - guidance

The model PaX-


i3D(PHT-6500) must be
used only in a shielded
location with a minimum
RF shielding effectiveness
and, for each cable that
exits the shielded location,
a minimum RF filter
Conducted
3 V r m s 3 Vrms 150 attenuation of 20 dB from
R F I E C
150 kHz to kHz to 80 30 MHz to 230 MHz, 20 dB
61000-4-6
80MHz 3 V MHz 3 V / m from 230 MHz to 1 GHz.
Radiated RF
/ m 80 MHz 80 MHz to Field strengths outside
IEC 61000-
to 2.5GHz 2.5 GHz the shielded location from
4-3
fixed RF transmitters,
as determined by an
electromagnetic site survey,
should be less than 3 V /
m.a Interference may occur
in the vicinity of equipment
marked with the following
symbol:

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Appendices

NOTE 1) These guidelines may not apply in all situations. Electromagnetic


propagation is affected by absorption and reflection from structures, objects
and people.
NOTE 2) It is essential that the actual shielding effectiveness and filter
attenuation of the shielded location be verified to assure that they meet the
minimum specification.

a Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength outside the shielded location in which the model
PaX-i3D(PHT-6500) is used exceeds 3V/m, the model PaX-i3D(PHT-6500)
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as relocating the
model PaX-i3D(PHT-6500) or using a shielded location with a higher RF
shielding effectiveness and filter attenuation.

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Appendices

4. 
A cquiring image for the pediatric
dental patient

4.1
Age group: classification table

Ages are classified loosely into the following correspondence between FDA
definition and one used in this manual.

Age Group FDA VATECH’s Standard

Infant 1 month to 2 years


Child
Child/Children 2 ~ 12 years of age

Adolescent 12 ~16 years of age

Other 16 ~ 21 years of age Adult

Adult > 21 years of age

The weak The weak: >60 years of age

4.2
Positioning the pediatric dental patient

Use a cotton roll to fill in missing primary teeth or partially erupted permanent
teeth. Adapt adult recommendation for direction of laser light beam guide for use
with primary teeth. Observe laser light beam guide on both the right and left sides.

1. Use laser light beam guide to locate mid sagittal plane. Direct patient focus to mirror
reflection. Affix decal to mirror to aid patient in maintaining the correct position throughout
exposure.

2. Move chinrest into a position that is slightly higher than the patient’s chin height before
requesting that the patient place chin onto the rest. Direct the patient to assume a position
that resembles the erect stance of a soldier.

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Appendices

3. Direct the patient to stick out the chest while dropping the chin down. While
holding the unit handles for stability, direct the patient to take a half step in
toward the vertical column of the X-Ray device into a position that feels as if
he/she is slightly leaning backward.

4. Direct the patient to the lips closed around the bite block during the
exposure.

5. Direct the patient to swallow and note the flat position of the tongue.
Request that the patient suck in the cheeks, pushing the tongue into the
correct flat position against the palate and maintain this position throughout
the exposure.

4.3
Setting exposure values to the age group

For more information about this topic, refer to the Appendices 13.1 Recommended
X-Ray Exposure Table.

4.4 
The references pertinent to the potential risks
for the pediatric patients
1. I. ESPELID, I. MEJÀRE, K. WEERHEIJM: EAPD guidelines for use of
radiographs in children, P40-48. European Journal of Pediatric Dentistry
1/2003

Guidelines in dental radiology are designed to avoid unnecessary


exposure to X-radiation and to identify individuals who may benefit from
a radiographic examination. Every prescription of radiographs should be
based on an evaluation of the individual patient benefit. Due to the relatively
high frequency of caries among 5 year old children it is recommended to
consider dental radiography for each child even without any visible caries
or restorations. Furthermore, radiography should be considered at 8-9
years of age and then at 12-14, that is 1-2 years after eruption of premolars
and second molars. Additional bitewing controls should be based on an
overall assessment of the caries activity/risk. The high-risk patient should
be examined radiographically annually, while a 2-3 years interval should be
considered when caries activity/risk is low. Routine survey by radiographs,
except for caries, has not been shown to provide sufficient information to
be justified considering the balance between cost (radiation and resources)
and benefit.

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Appendices

2. MICHAEL L. TAYLOR, B.SC. TOMAS KRON, PH.D., AND RICK D.


FRANICH, PH.D.: ASSESSMENT OF OUT-OF-FIELD DOSES IN
RADIOTHERAPY OF BRAIN LESIONS IN CHILDREN, Int. J. Radiation
Oncology Biol. Phys., Vol. -, No. -, pp. 1–7, 2010

To characterize the out-of-field doses in pediatric radiotherapy and to


identify simple methods by which out-of-field dose might be minimized, with
a view to reducing the risk of secondary cancers

Out-of-field doses to pediatric patients can be minimized by using simple


treatment options, such as using the single-energy mode linear accelerator
rather than the multimode, orienting the couch and collimator such that the
patient lies along the x-plane and avoiding fields directed along the trunk of
the body

3. C. THEODORAKOU, K. HORNER, K. HOWARD, A. WALKER: Pediatric


organ and effective doses in dental cone beam computed tomography

Dental CBCT has been associated with higher radiation risk to the patients
compared to conventional dental X-Ray imaging. Several studies have
investigated the radiation doses involved in dental CBCT for adults but
none has looked into pediatric doses. This study estimates the organ and
effective doses to two pediatric tissue-equivalent phantoms using thermo
luminescent dosimeters for three dental CBCT units and six imaging
protocols. The doses to the thyroid, salivary glands and brain ranged from
0.068mSv to 1.131mSv, 0.708mSv to 2.009mSv and 0.031mSv to 1.584mSv
respectively. The skin and red bone marrow have received much lower
doses than the other three organs. The effective doses ranged from 0.022
mSv to 0.081 mSv. The effective doses calculated in this study were much
higher than these of panoramic X-Ray imaging but lower than conventional
CT

4. CHIYO YAMAUCHI-KAWAURA & KEISUKE FUJII & TAKAHIKO


AOYAMA & SHUJI KOYAMA & MASATO YAMAUCHI: Radiation dose
evaluation in head and neck MDCT examinations with a 6-year-old child
anthropomorphic phantom, Pediatr Radiol (2010) 40:1206–1214 DOI
10.1007/s00247-009-1495-z

Background: CT examinations of the head and neck are the most


commonly performed CT studies in children, raising concern about radiation
dose and their risks to children.

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Appendices

Objective: The purpose of this study was to clarify radiation dose levels
for children of 6 years of age undergoing head and neck multi-detector CT
(MDCT) examinations.

Materials and methods: Radiation doses were measured with small-sized


silicon-photodiode dosimeters that were implanted at various tissue and
organ positions within a standard 6-year-old anthropomorphic phantom.
Organ and effective doses of brain CT were evaluated for 19 protocols in
nine hospitals on various (2–320 detector rows) MDCT scanners.

Results: The maximum value of mean organ dose in brain CT was 34.3
mGy for brain. Maximum values of mean doses for the radiosensitive lens
and thyroid were 32.7 mGy for lens in brain CT and 17.2 mGy for thyroid in
neck CT. seventy-fifth percentile of effective dose distribution in brain CT
was approximately the same as the diagnostic reference level (DRL) in the
2003 UK survey.

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Appendices

5
Abbreviations
AC Alternating Current

AF Auto-Focusing

AMPT Adaptive layer Mode Panoramic Tomography

CAN Controlled Area Network

CBCT Cone-Beam Computed Tomography

CMOS Complementary Metal-Oxide-Semiconductor

CT Computed Tomography

DAP Dose Area Product

DC Direct Current

DICOM Digital Imaging and Communications in Medicine

EMC Electromagnetic Compatibility

ENT Ear, Nose and Throat

ESD ElectroStatic Discharge

EUT Equipment Under Test

FDD Focal spot to Detector Distance

FOD Focal spot to Object distance

FOV Field of View

FPD Flat Panel Detector

IEC International Electro technical Commission

ISO International Standards Organization

LCD Liquid Crystal Display

LED Light-Emitting Diode

MAR Metal Artifact Reduction

MPSO Multiple Portable Socket-Outlet

ODD Object to detector distance

PA Posterior/Anterior

RF Radio Frequency

ROI Region of Interest

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Appendices

SID Source to Image receptor Distance

SIP Signal Input Part

SOP Signal Output Part

SMV Submento-Vertical

TMJ Temporomandibular Joint

UHD Ultra High Definition

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Copyright by © 2018 VATECH

All rights reserved.


The documentation, brand name and logo used in this manual are
copyrighted.
No part of this manual may be reproduced, transmitted, or transcribed
without the expressed written permission of the manufacturer.
We reserve the right to make any alterations which may be required due
to technical improvement. For the most current information, contact your
VATECH representative.

Manufactured by VATECH Co., Ltd.

Tel: +82-1588-9510
Email: [email protected]
Website: www.vatech.co.kr

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


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

The CE symbol grants this product compliance to the


European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class II b device.

EC Representative; Vatech Dental Manufacturing Ltd.


Suite 3, Ground Floor, Chancery House, St. Nicholas Way,
Sutton, SM1 1JB UK

Tel: +44-0208-652-1900, +44-0208-643-7109


Fax: +44-0208-652-1909

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Postal Code: 18449
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea
www.vatech.co.kr

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