2018 Vatech

Download as pdf or txt
Download as pdf or txt
You are on page 1of 168

PaX-I Insight / PaX-I Plus (Model: PCH-30CS)

User Manual (1.31 version)


English
Notice

Notice
Thank you for purchasing the PaX-i Plus / PaX-i Insight (Model: PCH-30CS) extra-
oral imaging system.

PCH-30CS is an advanced digital diagnostic system that incorporates PANO, CEPH


(Optional) and 3D PHOTO (Optional) imaging capabilities into a single system. PCH-
30CS is classified into two types – PaX-i Plus and PaX-i Insight - according to the
availability of Insight PAN function.

Module Option details


PaX-i Plus NP PANO only
PaX-i Insight NP PANO only
PaX-i Plus NC PANO + CEPH
PaX-i Insight NC PANO + CEPH

This manual describes how to operate the PCH-30CS system and covers differences
of the specifications between PaX-i Plus and PaX-i Insight. It is recommended that
you thoroughly familiarize yourself with this manual to make the most effective use of
this equipment.

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

Due to constant technological improvement, the manual may not contain the most
updated information and is subject 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.

PCH-30CS is referred to as “equipment” in this manual.

Manual Name: PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual

Document Name: VDH-UM-070

Version: 1.31

Publication Date: 2018-03

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual v


Notice

Left blank intentionally

vi PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


Table of Contents

Table of Contents
Notice................................................................................................................. v

Table of Contents ............................................................................................. vii

1. Introduction ........................................................................................ 1

1.1 Overview ......................................................................................... 1


1.2 Indications for Use ........................................................................... 1
1.3 Intended Purposes ........................................................................... 1
1.4 Intended User Profiles ...................................................................... 2

2. General Information ............................................................................ 3

2.1 Manufacturer's Liability ..................................................................... 3


2.2 Owner and Operator's Obligations ..................................................... 3
2.3 Conventions in this Manual ............................................................... 4
2.4 Marks and Symbols .......................................................................... 5

3. Warnings and Precautions ................................................................... 9

3.1 General Safety Guidelines ................................................................. 9


3.2 Electricity-related Safety Precautions ............................................... 13
3.3 Radiation Safety ............................................................................. 15
3.4 Warnings ....................................................................................... 16

4. Imaging System Overview ................................................................ 19

4.1 System Components ....................................................................... 19


4.2 Features ........................................................................................ 19
4.3 Standards and Regulations ............................................................. 20
4.4 Operating Principles ....................................................................... 20
4.5 Imaging System Configuration ........................................................ 21
4.6 Equipment Overview ..................................................................... 23

5. Imaging Software Overview .............................................................. 29

5.1 PC Specifications (Recommended) .................................................. 29


5.2 EzDent-i / EasyDent ....................................................................... 31
5.3 Console Software ........................................................................... 32

6. Getting Started .................................................................................. 36

6.1 Turning on the Equipment .............................................................. 36


6.2 Running the Image Viewer (EzDent-i / EasyDent)............................. 37
6.3 Initiating the Console Software ....................................................... 42

7. Acquiring PANO Images .................................................................... 44

7.1 PANO Imaging Program Overview ................................................... 44

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual vii


Table of Contents

7.2 Configuring Exposure Parameters.................................................... 49


7.3 Patient Positioning .......................................................................... 54
7.4 X-ray Exposure ............................................................................... 69
7.5 Finishing the Scan .......................................................................... 70
7.6 Checking the Captured Images ....................................................... 70

8. Acquiring CEPH Images (Optional) ................................................... 72

8.1 CEPH Imaging Program Overview.................................................... 72


8.2 Configuring Exposure Parameters.................................................... 74
8.3 Patient Positioning .......................................................................... 77
8.4 X-ray Exposure ............................................................................... 87
8.5 Finishing the Scan .......................................................................... 88
8.6 Checking the Captured Images ....................................................... 88

9. Acquiring 3D PHOTO Images (Optional) ........................................... 90

9.1 3D PHOTO Imaging Program Overview ............................................ 90


9.2 Taking 3D PHOTOs ......................................................................... 91
9.3 Checking 3D PHOTOs ..................................................................... 97

10. Troubleshooting ................................................................................ 98

10.1 Troubleshooting ............................................................................. 98


10.2 Error Codes ................................................................................... 99

11. Cleaning and Maintenance .............................................................. 102

11.1 Cleaning .......................................................................................102


11.2 Maintenance .................................................................................103

12. Disposing of the Equipment ............................................................ 104

13. Technical Specifications .................................................................. 106

13.1 Mechanical Specifications ..............................................................106


13.2 Technical Specifications .................................................................108
13.3 Electrical Specifications .................................................................115
13.4 Environmental Specifications .........................................................116

14. Appendices ...................................................................................... 118

14.1 Recommended X-ray Exposure Tables.............................................118


14.2 X-ray Dose Data ............................................................................125
14.3 Electromagnetic Compatibility (EMC) Information ............................138
14.4 Hand-wrist Image Evaluation References ........................................143
14.5 Acquiring Images for Pediatric Dental Patients ................................147
14.6 Abbreviations ................................................................................157

viii PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


1. Introduction
0Table of Contents

1. Introduction

ENGLISH
1.1 Overview
PaX-i Plus / PaX-i Insight (Model: PCH-30CS) is an advanced 3-in-1 digital X-ray
imaging system that incorporates PANO, CEPH (Optional) and 3D PHOTO (Optional)
imaging capabilities into a single system and acquires 2D diagnostic image data in
conventional panoramic and cephalometric modes.

1.2 Indications for Use

PCH-30CS is intended to produce panoramic or cephalometric digital x-ray images. It


provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and
pediatric patients. The system also utilizes carpal images for orthodontic treatment.
The device is to be operated by physicians, dentists, and x-ray technicians.

1.3 Intended Purposes

- Determination of the extent of lesions, tumors, cysts, etc., which cannot be fully
visualized on plain films
- Diagnosis of foreign bodies or displaced roots involving the maxillary sinus
- Diagnosis of bone diseases, cysts, etc., affecting the temporomandibular joints
- Identifying the relationship of the inferior dental canal to a tooth/lesion that is to be
removed
- Diagnosis of un-erupted teeth impacted teeth and odontomas
- Diagnosis of root resorption of teeth
- Instant diagnosis of CRS (chronic rhinosinusitis)
- Assessment of fractures on maxilla, mandible, condylar neck and fractures of teeth
where plain film imaging is equivocal

- Detailed verification of images in depth direction (PaX-i Insight only)

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 1


1. Introduction

1.4 Intended User Profiles

Considerations Requirement Description


▪ Licensed dentists or dental hygienists, radiologists
Education and graduates of relevant bachelor’s degree
(national qualifications)
▪ Understanding of the treatment and diagnosis of
dental disease
Knowledge ▪ Understanding the terms and guidance of
hardware and software of a diagnostic medical
radiation device and recognizing device
connection, installation, operating conditions
▪ Understanding how to use manuals (English /
Language Korean)
understanding Or
▪ Understanding other language provided
▪ Understanding of the objectives and effects of the
diagnosis and treatment of dental disease using
diagnostic medical radiation devices
Experience
▪ Understanding of the normal operation of
diagnostic medical radiation equipment
▪ Understanding of the contents of the User Manual

The dental X-ray equipment should be used by qualified personnel


(dentists, dental hygienists, radiologists) only.

2 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


2. General Information
0Table of Contents

2. General Information

ENGLISH
2.1 Manufacturer's Liability

The manufacturers and/or retailers of this X-ray 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 the cautions and
conditions required for installation.

▪ The genuine VATECH approved equipment and components have been used
always.

▪ All maintenance and repairs have been performed by a VATECH-authorized


agent.

▪ The equipment has been used normally in accordance with the User Manual.

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

2.2 Owner and Operator's Obligations

▪ The owner of this equipment shall perform constancy tests at regular intervals 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 work is performed in
accordance with the maintenance schedule outlined in Chapter 11. Cleaning and
Maintenance.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 3


2. General Information

2.3 Conventions in this Manual

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

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

Indicates information that should be followed with


the utmost care. Failure to comply with a warning
WARNING
may result in severe damage to the equipment or
physical injury to the operator and/or patient.
Indicates a situation that demands prompt and
CAUTION careful action, a specific remedy, or emergency
attention.

Indicates a situation or action that could


IMPORTANT potentially cause problems to the equipment
and/or its operation.

Emphasizes important information or provides


NOTE
useful tips and hints.

Indicates a possible danger from exposure to


RADIATION
radiation.

Indicates a component which must be replaced


SINGLE USE
for each new patient.

ESD Indicates that an item is susceptible to damage


susceptibility from electrostatic discharges.

4 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


2. General Information
0Table of Contents

2.4 Marks and Symbols

ENGLISH
Symbols Description Location

Power board /
Dangerous voltage Inverter board /
Monoblock

Protective earth (Ground) Column

Off (power: disconnected to the Main Power


Main Power Switch) Switch

On (power: connected to the Main Power


Main Power Switch) Switch

Alternate current Label

Type B Applied Equipment


(IEC 60601-1: Degree of
protection against leakage Label
current and/or electric shock:
Class 1 equipment)

Radiation hazard Label

Indicates the authorized


representative in the European Label
Community.

The CE symbol indicates that


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

CSA mark
Label
No.266436

Caution: Federal law restricts


this device to sale by or on the
order of a licensed healthcare
Label
practitioner.

Addresses where the


equipment was manufactured.
Label

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 5


2. General Information

Symbols Description Location


Indicates that electrical and
electronic equipment must not
be disposed of as unsorted Label
municipal waste and must be
collected separately.

MCU board /
Warns ESD hazard.
Board package

Indicates that this equipment is


classified as a CLASS 1
LASER PRODUCT in Label
accordance with IEC 60825-1
ED.2 regulations.

Indicates that the user needs to


refer to the Instruction Label
Manual.

Indicates the date of


manufacture.
Label

Indicates the manufacturer's


serial number so that the
specific equipment can be
Label
identified.

6 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


2. General Information
0Table of Contents

2.4.1 Label Locations

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

No. Item

1 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) Main Label

CAUTION Label
2
- X-ray / Attention: X-ray on when equipment in operation.
X-RAY GENERATOR Label
3
: 1.0 kW Generator

4 CLASS 1 LASER PRODUCT Label

Manufacturer Label
5
- The date of manufacture / Serial Number / Weight of the equipment

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 7


2. General Information

Left blank intentionally

8 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


3. Warnings and Precautions
0Table of Contents

3. Warnings and Precautions

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

This x-ray unit may be dangerous to patients and operators unless


safe exposure factors, operating instructions, and maintenance
schedules are observed.

3.1 General Safety Guidelines

Operator qualifications

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

▪ To operate this equipment, the operator must:

- Have read and understood the User Manual.

- Be familiar with the fundamental structure and functions of this equipment.

- Can recognize the irregular 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 vocal/visual contact with the patient always during
imaging.

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

▪ Do not place any heavy objects on this equipment at any time.

▪ Do not place any objects within this equipment’s field of operation. It may cause
property damage.

▪ Do not push or pull the equipment. Overbalances of the equipment may cause
the risk of physical injuries or property damage.

▪ The operator must instruct the patient to remain still until the equipment arm has
stopped moving and the reset motion is completed.

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

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 9


3. 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 always.

▪ If this product is exposed to water, moisture, or a foreign substance, immediately


turn off the main power of the equipment and contact your VATECH technical
support representative.

▪ If there are signs of oil leakage, immediately cease all operations of this
equipment and contact your VATECH technical support representative.

▪ External equipment intended for connection to signal input, signal output or other
connectors, shall comply with relevant IEC Standard (e.g., IEC 60950 for IT
equipment and IEC 60601-1series for medical electrical equipment).

▪ In addition, all such combination-system-shall comply with the standard IEC


60601-1 and/or IEC 60601-1-1 harmonized national standard or the combination.
If, in doubt, contact qualified technician or your local representative.

▪ Any person or organization who installs external door interlock switch is


responsible for ensuring that it has radiation indicator or equivalent alarm system
to show the state of a current.

Ventilation

▪ Do not close the equipment’s ventilation slots in any cases. Obstruction of


ventilation could result in the equipment overheating due to a lack of air
circulation.

▪ Do not spray any type of liquid or disinfectant on this equipment. Penetration of


these substances may damage the electrical and mechanical components inside.
Use a soft cloth to disinfect the ventilation slots.

▪ Always leave enough space around the PC to allow for proper ventilation.

Hygiene

▪ Always disconnect the equipment from the power outlet when


disinfecting the surfaces of the equipment.
▪ Never expose this equipment to liquids, mists or sprays. Exposing
this equipment to liquids may cause an electric shock or otherwise
damage the system.
▪ Do not use spray cleaners on the equipment, as this could cause a
fire.

10 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


3. Warnings and Precautions
0Table of Contents

▪ All removable patient support components (the Bite, the Chinrest, the Temple
Supports and the Ear Rods) can be cleaned using alcohol-based cleaning

ENGLISH
solutions.

▪ Clean the Support Handles by using alcohol-based cleaning solutions before


taking photos of next patient.

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

▪ A new Sanitary Vinyl Cover must be provided for each new patient to prevent the
transmission of communicable disease.

If the Sanitary Vinyl Covers go out of stock, please contact the


customer service or purchase additional ones (ISO10993-1) that has
proven to be bio-compatible.

Condensation

▪ Extreme fluctuation 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)
before the acquisition of next image.

- Mode of operation: Continuous operation with intermittent loading - Needs


waiting time (at least 60 times the exposure time) before the next exposure
begins

- Column operation time: Max. 2 min. On / 18 min. Off (Ratio 1:9)

▪ If the temperature inside the tube head reaches 60 °C (140 °F), X-ray exposure
will cease, and an error message will be displayed. Normal X-ray capabilities will
resume after the generator reaches 58 °C (136.4 °F).

▪ If the fan (optional) is installed, it operates automatically when the temperature


surrounding the tube head reaches the pre-defined level: 40 °C (104 °F). The
setpoint temperature is configurable.

Turning the equipment on / Adjusting the height of the equipment

▪ Do not position the patient near 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 equipment while adjusting its height.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 11


3. Warnings and Precautions

Emergency stops

▪ 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. (Emergency Stop Switch is located at the bottom of the Vertical
Frame. Turn the switch in the direction of the arrow to reboot the equipment.)

Trouble-free operation

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

▪ Always operate the equipment within a temperature range of 10 °C to 35 °C


(50 °F to 95 °F) for the safe operation. Image quality may deteriorate if the
equipment is operated outside of this range.

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

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

▪ Always ensure that equipment movement is not obstructed by the patient’s


clothing, a 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,
patients or other persons is prohibited by law.

▪ No part of this equipment is serviceable by the operator. All maintenance and


repair of this equipment must be performed by a VATECH qualified service
technician.

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

12 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


3. Warnings and Precautions
0Table of Contents

3.2 Electricity-related Safety Precautions

ENGLISH
To avoid the risk of electric shock, this equipment must only be
connected to supply mains with protective earth.

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

▪ Ensure that Main Power Switch is set to off when the equipment is not in use.

▪ Always disconnect the power supply before cleaning the equipment.

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

▪ DO NOT place the PC or peripheral equipment connected to the PC in the


immediate vicinity of the patient.

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

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

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

Combining this equipment with other devices

▪ Do not connect this equipment to devices which are not designated as a part of
the system.

▪ Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO) or


extension cord which is not provided with the equipment.

Electromagnetic compatibility

▪ This X-ray equipment complies with IEC standard 60601-1-2.

▪ Medical electrical equipment is subject to special Electromagnetic Compatibility


(EMC) preventive measures. It must be installed and operated as specified in
EMC information.

▪ 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 Radio Frequency (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 14.3 Electromagnetic Compatibility (EMC)


Information.

▪ Please also observe the Electro-Static Discharge (ESD) protective measures


described.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 13


3. Warnings and Precautions

Static Discharge

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

Electrostatic discharge (ESD)

ESD protective measures include

▪ Procedures for preventing electrostatic charge build-up (e.g. temperature control,


humidification, conductive floor coverings and non-synthetic clothing)

▪ Electrostatic discharge of your own body with the frame of the equipment, the
protective ground wire or large metallic objects

▪ Use of the wristband for grounding

14 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


3. Warnings and Precautions
0Table of Contents

3.3 Radiation Safety

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

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

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

▪ During imaging; the operator must maintain vocal/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 should be at least 2 m (6 feet) away from the equipment during
imaging.

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

▪ 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.

As a manufacturer of radiology equipment that conforms to stringent


protection standards around the world, we guarantee the maximum
degree of protection against radiation hazards for our equipment.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 15


3. Warnings and Precautions

3.4 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 the operator.

▪ X-ray equipment is hazardous to patient and the operator if proper


exposure safety measures and/or operating instructions are not
observed.
▪ It is important to read this User Manual carefully and strictly abide
by all warnings and cautions stated within it.

▪ Where it is likely that evaluation of soft tissues will be required as


part of the patient’s radiological assessment, conventional medical
CT or MR should be used instead of dental cone beam imaging.

▪ PCH-30CS system, like other medical equipment’s, 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.
▪ PCH-30CS system is designed to withstand the effects of
defibrillation. However, when possible, disconnect the Dental X-ray
system during defibrillation since a malfunction of the safety
controls could otherwise result in electrical burns for the patient.

Federal law restricts this device to sale by or on the order of dentist or


with the descriptive designation of any other practitioner licensed by
the law of the State in which he practices using or order the use of the
device.

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.

▪ Wavelength: 650 nm, Radiant power: Max. 0.39 mW

Risk of eye injury!


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

16 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


3. Warnings and Precautions
0Table of Contents

Cleaning

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

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

During the 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 to
immediately stop all moving parts and cut off all power to the equipment’s
electrical components.

▪ Never touch the patient while he or she is touching the SIP/SOP connectors.

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

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

In case of an 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 physical injury.

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

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 17


3. Warnings and Precautions

Installation

▪ 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.

For further details on installation, refer to the PaX-i Plus / PaX-i


Insight (Model: PCH-30CS) Installation Manual.

Security Capabilities

▪ It is recommended to install and operate EzDent-i / EasyDent SW within a


secure operating environment that allows only authorized users to access and a
system network equipped with Windows built-in firewall, Windows Defender
antispyware tools and other commonly used 3rd party security tools and
application systems.

▪ The latest updates for anti-virus software and a firewall are recommended.

▪ The software can be updated by the manufacturer only. Unauthorized software


update through a third party, not the manufacturer, is strictly prohibited. For
cybersecurity issues related to the software and medical devices, please contact
the manufacturer.

18 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


4. Imaging System Overview
0Table of Contents

4. Imaging System Overview

ENGLISH
4.1 System Components

▪ PaX-i Plus / PaX-i Insight (Model: PCH-30CS) X-ray equipment

▪ PC system

▪ Console Software: PANO, CEPH (Optional) and 3D PHOTO (Optional)

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

4.2 Features

▪ The multi-imaging solution for Accurate Diagnostics

▪ Conventional 2D (PANO and CEPH (Optional)) image acquisition in high quality

- PANO: Optionally implemented improved multi-image acquisition technology


that reconstructs the panoramic image into multiple images with different
focal planes at one take.

- CEPH: Minimized motion artifact through short scan time

▪ DICOM (Digital Imaging Communication in Medicine) format supported

▪ 3D PHOTO acquisition with a 3D photo camera (Optional)

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 19


4. Imaging System Overview

4.3 Standards and Regulations

Standards

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) is designed and developed to comply
with the following international standards and regulations:

▪ IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63

▪ CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1-3:09, CAN/CSA-


C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-2-63:15, CAN/CSA-IEC
62366:15

▪ ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, A2:2010 / (R)2012


(Consolidated text - edition 3.1)

▪ 21 CFR 1020.30, 31, 33

▪ NEMA Standard publication PS 3.1-3.18, 2008

This is Class IIb equipment and obtained CE marking in


April 2007 for regulations compliance in accordance with
the revised European Union’s MDD (Medical Devices
Directive) 93/42 EEC.

This equipment received the CSA certification mark in


accordance with CAN/CSA C22.2 No.601.1 regulations.

Classifications (IEC 60601-1 6.1)

▪ The degree of protection against water ingress: Ordinary Equipment: IPX0

▪ The degree of protection against electric shock: Class 1 equipment, Type B


Applied Parts: Temple Supports, Chinrests, and Bites.

4.4 Operating Principles

X-ray is emitted when a high voltage is supplied to X-ray tube assembly which frees
electrons from the cathode.
They hit anode to produce X-ray. The machine acquires images by emitting X-ray
continuously and rotates on the human tooth at different angles.
Images are acquired, computed and recompiled to reproduce 2D images.

20 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


4. Imaging System Overview
0Table of Contents

4.5 Imaging System Configuration

ENGLISH
Input / Output for PC

No. Item
USB Camera input (USB 3.0 Cable)

1 To avoid any connection problem, it is highly recommended to


install a USB 3.0 PCI card for USB 3.0 cables.

2 3D viewer License Key

3 Video output
4 Fiber optic cable (Data in / out)

Signal Input & Output for Column UP/DOWN Switch


PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 21
4. Imaging System Overview

The equipment connected to the signal input, signal output or other


connectors must comply with the relevant IEC standards (e.g.,
IEC60950 for IT equipment and IEC60601-1 series for medical
electrical equipment).
In addition, all such combination systems must comply with
IEC60601-1 and/or relevant combination standards. If in doubt,
contact a qualified technician or your local VATECH representative.

22 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


4. Imaging System Overview
0Table of Contents

4.6 Equipment Overview

ENGLISH
No. Item Description
X-ray Detector
1 for CEPH Xmaru2602CF for CEPH imaging sensor
(Optional)

− Positions the patient during CEPH imaging.


2 Nasal Positioner − The ruler used for reference in an acquired image
that is different from the actual size
3 Ear Rods Secure the patient’s head during CEPH imaging.
Emergency Stop Immediately stops the moving parts and cuts off all
4
Switch power to the equipment’s electrical components.
5 D-Sub Connector The input signal port for Column UP/DOWN Switch
6 Main Power Switch Turns on / off the main power of the equipment.
Horizontal Beam
7 Aligns the Horizontal Beam in PANO mode.
Lever
Held firmly by the patient during imaging to stabilize his /
8 Handle Frame
her position.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 23


4. Imaging System Overview

No. Item Description


Column
9 UP/DOWN Switch Adjusts the height of the Vertical Frame.
(optional)
Moves by the Column UP/DOWN button or switch for
10 Telescopic Column
patient positioning.
11 Stationary Column Supports whole part of the equipment.
12 Base (Optional) Balances the equipment and maintains its safety.
3D PHOTO camera
13 Camera for taking 3D PHOTO
(Optional)
Holds the Rotating Unit.
14 Vertical Frame
Can be controlled by Column UP/DOWN switch.
15 X-ray Generator The vacuum tube where the X-ray is produced.
Rotates around the patient's head while the image is
being acquired.
16 Rotating Unit
(Its movement is different according to the scan
mode.)
Displays the status of X-ray exposure.
17 LED Lamp - Green: Standby
- Yellow: In operation

X-ray Detector for ▪ PaX-i Plus: Xmaru1501CF-PLUS


18
PANO ▪ PaX-i Insight: Xmaru1404CF-PLUS
Supports patient’s head by holding the temples.
19 Temple Supports
Used in the PANO mode.
20 Chinrest The place to rest the chin.
Canine Teeth Beam
21 Aligns the Canine Teeth Beam in PANO mode.
Lever
Temple Supports
22 OPEN/CLOSE Adjusts the Temple Supports for patient positioning.
Wheel
Operates the Laser Beam and adjusts the height of
the Vertical Frame. (For the details, refer to 4.6.1
Control Panel.)
23 Control Panel

24 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


4. Imaging System Overview
0Table of Contents

4.6.1 Control Panel

ENGLISH
No. Item Description

Column UP/DOWN Moves the Vertical Frame up or down.


1
button (For adjusting the height of the Chinrest)

Laser Beam
2 Turns the Laser Beam on / off.
ON/OFF button

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 25


4. Imaging System Overview

4.6.2 Emergency Stop Switch

During operation, the following emergency situations may occur:

▪ X-ray emission even after the Exposure Switch has been released

▪ Physical 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 restart the equipment, turn the Emergency Stop Switch clockwise
until it pops up.

The Emergency Stop Switch is located at the bottom of the Vertical Frame.

26 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


4. Imaging System Overview
0Table of Contents

4.6.3 Exposure Switch

ENGLISH
The Exposure Switch allows the operator to control image acquisition from outside of
the X-ray room.

Press and hold the Exposure Switch down until acquisition is completed. Premature
release of the Exposure Switch will abort image acquisition.

Pressing the Exposure Switch activates the LED indicator to turn yellow. This color
indicates that the X-ray is being emitted.

▪ The Exposure Switch is detachable. Ensure the Exposure


Switch cable is not detached from the unit accidentally during the
operation.
▪ Keep vocal/visual contact with the patient during exposure. If any
problem occurs during exposure, release the Exposure Switch
immediately.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 27


4. Imaging System Overview

4.6.4 Enclosed Components

The enclosed components can be disassembled and cleaned. All enclosed


components that are used to support the patient (the Bite, the Chinrest, the Ear Rods
and the Temple Supports) should be cleaned with ethanol and wiped with clean towels.

Components Name and Function Materials

Normal Bite
PC (Polycarbonate)
: For PANO

Special Bite A
: For PANO TMJ and Sinus PC (Polycarbonate)
modes
Special Bite B
: For PANO edentulous PC (Polycarbonate)
patients

Normal Chinrest ABS (Acrylonitrile


butadiene styrene)
: For Normal Bite copolymer

Special Chinrest ABS (Acrylonitrile


: For Special Bite A and butadiene styrene)
Special Bite B copolymer

Temple Supports (1 set) PC (Polycarbonate)

Ear Rods (1 set) Silicone


Nasal Positioner Cover
Silicone
: For CEPH

Carpus Plate PC (Polycarbonate)

Sanitary Vinyl Covers


(disposable) for the Bite
LDPE (Low-density
polyethylene)

Protractor (1 set)
: For positioning the patient’s PC (Polycarbonate)
body in CEPH mode.

28 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


5. Imaging Software Overview
0Table of Contents

5. Imaging Software Overview

ENGLISH
Three programs are included in this equipment to acquire, process, and view the
image:

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

▪ Console software: PANO, CEPH (Optional) and 3D PHOTO (Optional)

5.1 PC Specifications (Recommended)

▪ The PC system plays an important role in image processing and


verification. Configure the PC environment to meet the following
specifications. If the PC specifications are not met, the image
quality can be lower.
▪ Do not place patients near the equipment and PC.

 PaX-i Plus

Item Specifications

CPU Intel Core i3-7100 3.9GHz 3MB cache, 2cores


Chipset Intel Q270
RAM 2X4GB DDR4-2400 DIMM NECC UNB
Hard disk drive 500GB SATA 7200 rpm
Graphics board Integrated Intel HD 630 Graphics
Ethernet interface Integrated Intel I219LM Gigabit Network
Intel Ethernet I210-T1 PCIe x1 Gb NIC (Option)
Serial Port (RS232) 1 (Onboard)

Power supply ≥ 400 Watts (93% Efficiency)

Slots 2 PCI Express x 1 Slot


2 PCI Express x 16 Slot
CD/DVD drive DVDRW
Operating system Windows 10 Professional 64 bit
Windows 7 Professional 64 bit
(available through downgrade rights from
Windows 10 Pro)

▪ If a grabber card needed to install, plug it into the x4 express slot.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 29


5. Imaging Software Overview

 PaX-i Insight

Item Specifications

CPU Intel Court i5-6500 3.2 2133 4C CPU


Chipset Intel C236 Chipset
RAM 16GB DDR4-2133 nECC (2x8GB) Unbuffered RAM
Hard disk drive 1TB SATA 7200 rpm
Graphic board NVIDIA GTX 1050Ti
Ethernet interface Integrated Intel I219LM PCIe GbE Controller
Serial Port (RS232) 3rd Serial 1 Port PCI-Express card
(NEXT-SL601 PCIe)
Power supply 400W (92% efficiency)

Slots 1 PCIe Gen3 x16 slots

1 PCIe Gen3 x4 slot /x16 connectors


1 PCIe Gen3 x4 slot/x4 connectors
1 PCIe Gen3 x1 slot
1 legacy PCI expansion slot (M6Q20AV)
CD/DVD drive DVDRW
Operating system Windows 10 Professional 64 bit
Windows 7 Professional 64 bit
(available through downgrade rights from Windows
10 Pro)

In Windows 10, disable Windows Defender When Windows


Defender is not enabled, Windows 10 is not protected from
malware and virus.

30 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


5. Imaging Software Overview
0Table of Contents

5.2 EzDent-i / EasyDent

ENGLISH
EzDent-i / EasyDent is imaging software from VATECH Co., Ltd. that manages
patient images to make faster and more accurate diagnoses. EzDent-i / EasyDent
linked with the console software, makes it convenient for the operator to use and
process necessary images. Various functions enable the acquired images to be
processed quickly and conveniently from the console software.

Please note that EzDent-i supports both PaX-i Plus and PaX-i Insight
while EasyDent supports PaX-i Plus only.

Please refer to 5.2.1 Creating a New Patient Record and 5.2.2


Retrieving Patient Records and EzDent-i / EasyDent User Manual
for more information.

Security Capabilities
▪ It is recommended to install and operate EzDent-i / EasyDent SW
within a secure operating environment that allows only authorized
users to access and a system network equipped with Windows
built-in firewall, Windows Defender antispyware tools and other
commonly used 3rd party security tools and application systems.
▪ The latest updates for anti-virus software and a firewall are
recommended.
▪ The software can be updated by the manufacturer only.
Unauthorized software update through a third party, not the
manufacturer, is strictly prohibited. For cybersecurity issues
related to the software and medical devices, please contact the
manufacturer.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 31


5. Imaging Software Overview

5.3 Console Software

Use the Console Software to configure the imaging environment according to the
mode.

▪ You can set the imaging parameters on the Console Software


running on the PC. They are synchronized and display the same
environmental settings.)
▪ To improve program functions, the Console Software may change
without notice

The Main Screen of the Console Software consists as follows. Each imaging mode will
be described later.

No. Item Description


Version
1 Displays the Console Software version.
Information
Displays and sets various equipment-related parameters,
2 Settings button
including language, automatic save, DAP display unit, etc.
3 EXIT button Exits the console software.
The radiation mark turns yellow and “X-RAY” changes to
4 X-ray indicator
“X-RAY ON”.

32 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


5. Imaging Software Overview
0Table of Contents

No. Item Description

ENGLISH
Imaging Mode
5 Displays the current imaging mode.
Display
Switches to the Rotation Test mode to check if any part of
the patient’s body reach to the surface of the equipment
before the actual exposure.
To change to the Rotation test mode,
1. Align the patient to the equipment. (For the details,
refer to the “Positioning the Patient” section of each
modality chapter.)
2. Select a modality.
3. Click CONFIRM button.
4. Click Rotation Test button. Then, the button is
changed to OFF state and icon.
Rotation Test
6
button

 To start rotation test, press BEAM ON/OFF


button on the Control Panel.

To finish the test mode, click Rotation Test button or


READY button.

This function is applied to PANO and CBCT


modalities only.

This function is used to acquire Phantom images.

Image acquisition using the Phantom Jig:


1. Click Phantom button.
7 Phantom button 2. Select the Modality and click Capture button.
3. Check the parameters displayed in the main
GUI window and align the Phantom Jig, and
then click the READY button.
4. Press and hold down the Exposure Switch.

Reconstructs the image manually when automatic image


Manual reconstruction fails:
8 Reconstruction Select a Modality after clicking this button. > Click Search
button button. > Select an image to reconstruct. > Click
Reconstruction button.

Laser Beam Turns the Laser Beam on or off for patient positioning.
9 Enabled when CONFIRM button is clicked after the
ON/OFF button imaging conditions are configured.

10 Patient Displays information on the selected patient.


Information
PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 33
5. Imaging Software Overview

No. Item Description


window
Scanning Status
Shows image acquisition progression and displays preview
11 and Image
of the images acquired.
Preview window
Modality Returns to Modality Selection (PANO and CEPH
12
Selection button (Optional)) screen.
Imaging
parameters Selects the imaging parameters for each mode: PANO and
13
configuration CEPH (Optional)
panel
DAP, Scan Time
Displays estimated DAP (Dose Area Product), scan time
and Exposure
14 and exposure time after exposure parameter settings are
Time Display
completed.
window
Guide Message
15 Displays various text instructions for the operator.
window
If the patient is selected in EzDent-i / EasyDent, the
default kVp / mA according to the patient’s information
(gender/age) is displayed. This tool adjusts the kVp and
mA values and controls the power of the X-ray to improve
Tube Voltage and image quality. If necessary, adjust the kVp and mA values
16 Current manually using the arrows.
Adjustment
For the tube voltage and its correspondence
with the selected patient, refer to 13.1
Recommended X-ray Exposure Table.

Displays the current patient’s gender/age group as entered


in EzDent-i / EasyDent’s patient information fields. If
necessary, gender/ age group can be manually selected.
Patient’s
17
gender/age group

Selects X-ray intensity.

Depending on the circumference of the patient’s


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

34 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


5. Imaging Software Overview
0Table of Contents

No. Item Description

ENGLISH
Applies the selected settings and moves to the next step.
(Exposure parameter setting and patient positioning >
Ready for exposure)

When you click CONFIRM button, estimated


CONFIRM / DAP (Dose Area Product), scan time and
19
READY button exposure time will be displayed DAP, Scan
Time and Exposure Time Display window.

Activated when you click CONFIRM button after the patient


positioning is completed. Click the button when all aspects
of preparation are completed for image acquisition.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 35


6. Getting Started

6. Getting Started
6.1 Turning on the Equipment
▪ Do not place the patient close to the equipment when it’s being
turned on. Doing so may cause physical injury to the patient and
damage to the equipment.
▪ Do not operate the PC while the equipment is in operation. Doing
so may cause an error in the equipment.

▪ Extreme fluctuation of temperature may cause condensation inside


the equipment. Do not switch on the equipment until it has reached
normal room temperature.
▪ Rebooting the equipment: After turning it off, wait for approx. 20
seconds before turning it on again.
▪ Warm-up the equipment for at least 5 minutes before the operation.
For the best image quality, it is recommended to have a warm-up
phase for more than 30 minutes.

If the equipment has not been used for a long time, please let it have
enough time to be warmed up. It extends the life of the X-ray tube.

1. The imaging system mainly consists of the imaging equipment and the PC.
2. Before turning on the equipment, please confirm that the equipment and PC have been
installed correctly.
3. Turn on the PC.
4. Press the Main Power Switch that is located at the bottom of the Vertical Frame to
turn on the equipment.

Main Power Switch isolates its circuits electrically from the supply
mains on all poles simultaneously.

5. Make sure that the green LED light at the top of the equipment is on.

36 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


6. Getting Started
0Table of Contents

6.2 Running the Image Viewer (EzDent-i / EasyDent)

ENGLISH
The Imaging Program is interfaced with EzDent-i / EasyDent and the user can
analyze the image acquired from the Console Software easily and rapidly. On your
desktop, double-click EzDent-i / EasyDent icon. The EzDent-i / EasyDent main
window will be displayed.

Please note that EzDent-i supports both PaX-i Plus and PaX-i Insight
while EasyDent supports PaX-i Plus only.

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


User Manual.

Security Capabilities
▪ It is recommended to install and operate EzDent-i / EasyDent
SW within a secure operating environment that allows only
authorized users to access and a system network equipped with
Windows built-in firewall, Windows Defender antispyware tools
and other commonly used 3rd party security tools and application
systems.
▪ The latest updates for anti-virus software and a firewall are
recommended.
▪ The software can be updated by the manufacturer only.
Unauthorized software update through a third party, not the
manufacturer, is strictly prohibited. For cybersecurity issues
related to the software and medical devices, please contact the
manufacturer.

For PCH-30CS dental computed tomography X-ray system, the


Console Software is being accessed through 2D viewer (EzDent-i /
EasyDent) SW. The Console Software does not have image storage
capacity of their own and both programs will not be able to keep
patient information.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 37


6. Getting Started

6.2.1 Creating a New Patient Record


To create a new patient record, follow the procedure outlined below:
EzDent-i
1. Click the PATIENT tab and click the Add Patient icon from the main GUI window.

2. Enter the required patient information. Chart Number, E-Mail address, First Name,
and Last Name are required fields which must be filled in. (The Chart Number is filled
in automatically.)
3. Click Add button to save the patient record.

38 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


6. Getting Started
0Table of Contents

EasyDent

ENGLISH
1. Click the Patient icon in the upper left corner of the EasyDent’s main GUI window.

2. 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 are filled in.

3. Click Add button to save the patient record.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 39


6. Getting Started

6.2.2 Retrieving Patient Records


You can search through the patient database using a patient’s Chart Number, First
Name, or Last Name.
EzDent-i
1. Enter the Name or Chart Number of the patient to be searched on the Patient Search
panel and then click the Search button. The information on the patient that fits the
search condition appears.

Double-click the Keyboard icon to display the virtual keyboard. You


may search patient information using the virtual keyboard.

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

40 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


6. Getting Started

EasyDent

1. 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.

2. Enter the Chart No., First name, or Last name of the patient by clicking the mouse on
the virtual keyboard and click Enter key. (The physical keyboard can be used to do the
same job)
3. Patient information can be displayed in the Patient Information panel and Patient
List.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 41


6. Getting Started

6.3 Initiating the Console Software

For a new patient, the patient information needs to be registered first.

EzDent-i
1. Search and select the patient to be captured.

2. Click ACQUISITION tab and select the imaging mode (CT, Panorama, or Cephalo).

3. The Main Screen for the selected mode appears. From the Main Screen, you can
configure the imaging parameter settings prior to acquiring an image.

Refer to the following chapters (7 & 8) for the more information on the
image acquisition.

42 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


6. Getting Started

EasyDent

1. First, click the patient information in the Patient List, and click an imaging modality
button to select on the upper left corner.

2. The Main Screen for the selected mode appears. From the Main Screen, you can
configure the imaging parameter settings prior to acquiring an image.

Refer to the following chapters (7 & 8) for the more information on the
image acquisition.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 43


7. Acquiring PANO Images

7. Acquiring PANO Images


7.1 PANO Imaging Program Overview
 Result Images

It provides conventional 2D panoramic images.

 Image Acquisition Method

It reconstructs U-shaped arch data to a single 2D image utilizing multiple images taken
with the X-ray beam scanning specific oral & maxillofacial regions at different angles.

 Available PANO Options

Mode Description
Normal Ordinary panoramic image acquisition option.
Auto Focusing Multi-image acquisition option that reconstructs the
(Optional) panoramic image as multiple focal images.
Multi-image acquisition option that reconstructs the
panoramic image into multiple focal images in depth
regions.
Insight PAN
Its main purpose is to diagnose depth regions,
which cannot be confirmed with ordinary panoramic
images.

 Examination Programs

It is classified as below based on the ROI (Region of Interest).

Examination
Arch Selection ROI Example
Type

Standard

Right
Narrow
Normal
PANO
Wide
Examination
Child
Orthogonal Front

Left

44 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

Examination
Arch Selection ROI Example
Type

Bitewing*

Bitewing Incisor*
(Optional)

Orthogonal

Bitewing Right*

Bitewing Left*

TMJ LAT Open

TMJ LAT Close

TMJ PA Open
(Optional)
SPECIAL
N/A
Examination
TMJ PA Close
(Optional)

Sinus LAT
(Optional)

Sinus PA

* Bitewing imaging mode is activated only when Orthogonal is selected in Arch Selection.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 45


7. Acquiring PANO Images

 Main Imaging Programs

Examination Arch
ROI Description & Sample Image
Type Selection
A panoramic imaging mode for
patients with a V-shaped arch
trajectory.
(Typically for some females)

Narrow Standard

A panoramic imaging mode for adult


patients with a normal arch
trajectory.

Normal Standard

PANO
Examination

A panoramic imaging mode for the


patients with a square-shaped arch
trajectory. (Typically for some males)

Wide Standard

A panoramic imaging mode for child


trajectory.
(Less X-ray exposure than the
Normal mode by approximately more
Child Standard than 40%)

46 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

Examination Arch
ROI Description & Sample Image
Type Selection

A panoramic imaging mode to


minimize the overlapped region of
the teeth from the X-ray exposure
which is beamed perpendicularly
between teeth.

Standard

A panoramic imaging mode to


acquire an image only for the region
of interest through the orthogonal
Orthogonal trajectory.
(Pros: less X-ray exposure than the
Normal mode. / Cons: TMJ and
some parts of the maxillary sinus
cannot be acquired.)

Bitewing**
(Bitewing
Incisor mode is
Optional)

An imaging mode to acquire a lateral


image of the TMJ, in which the X-ray
SPECIAL TMJ LAT
N/A beam is directed on the lateral TMJ
Examination Open / Close
region.
(TMJ Open and Close)

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 47


7. Acquiring PANO Images

Examination Arch
ROI Description & Sample Image
Type Selection

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.
TMJ PA
Open / Close
(Optional)

A special imaging mode to acquire a


Sinus image, in which X-ray beam is
directed on the lateral region of the
maxillary sinus.
Sinus LAT
(Optional)

A special imaging mode to acquire a


Sinus image, in which X-ray beam is
directed on the frontal region of the
maxillary sinus.
Sinus PA

** Bitewing imaging mode is activated only when Orthogonal is selected in Arch Selection.

48 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

7.2 Configuring Exposure Parameters


To acquire PANO Images, 6. Getting Started must be completed first. If not, you must
return to the 6. Getting Started and finish the step first.

You can set the imaging parameters on the Console Software running
on the PC. They are synchronized and display the same environmental
settings.

1. Click PANO button in the Modality Option of the Main Screen.

“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 49


7. Acquiring PANO Images

2. Select a Pano Option.

PaX-i Plus

PaX-i Insight

Mode Description
Normal (Default) - Provides a normal panoramic image.

Auto Focusing - Selectively provides specific multiple panoramic images


(Optional) having different focal planes.

Insight PAN - Provides multiple panoramic images having different focal


(FOR PaX-i Insight planes along with a normal panoramic image together.
Only) - Enables detailed verification of images in depth direction.

3. Select an Image Option.

Mode Description
UHD (Optional) Ultra High Definition image
HD (Default) High Definition image
Normal Normal quality image

When “Insight PAN” is selected with PaX-i Insight, Image Options


are disabled.

50 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

4. Make an Arch Selection.

Arch Selection Description


Panoramic image of V-shaped palatal arches (small number
Narrow
of adult females)
Normal Panoramic image of normal adult palatal arches
Panoramic image of square-shaped palatal arches (some
Wide
number of adult males)
Panoramic image of child palatal arches, approximately more
Child
than 40% less X-ray dose than in Normal mode.
Panoramic image where the x-ray angle enters vertically in
between the teeth so overlapping images are minimized.
If Orthogonal Arch is selected, Bitewing
Orthogonal
examinations (Bitewing, Bitewing Incisor
(Optional), Bitewing Right, Bitewing Left) are
activated.

5. Select an Examination Program in the Pano Examination or Special Examination panel.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 51


7. Acquiring PANO Images

▪ To activate Bitewing examination options - Bitewing, Bitewing


Incisor (Optional), Bitewing Right, Bitewing Left, select Orthogonal
Arch in the Arch Selection panel.

▪ When a Special Examination option is clicked, “PANO Examination”


panel is disabled. If you want to select a PANO Examination option,
please conduct Arch selection again.
▪ For more information about Examination Program, refer to 7.1
PANO Imaging Program Overview.

6. The Gender / Age group of the patient is selected automatically based on the patient
information. If necessary, you can select the option manually.

7. Select X-ray intensity.

Depending on the circumference of the patient’s head, X-ray intensity


may be classified as Hard, Normal, or Soft:
Soft ≤ Normal ≤ Hard

52 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

8. The values of tube voltage and current are configured automatically according to the
patient's gender/age group and X-ray intensity. Click the UP/DOWN arrow to adjust
kVp and mA. The dose is adjustable by ±1 kVp and ±1 mA respectively.

9. Click CONFIRM button when exposure parameter setting is completed.

When you click CONFIRM button,


▪ The Rotating Unit will move to its scanning position.
▪ The READY button will be activated. (This means that the
equipment is ready for X-ray exposure.)
▪ Three Laser Beams (Vertical Beam, Horizontal Beam, and Canine
Teeth Beam) will be activated.
- The Laser Beams are turned off automatically after 20 minutes or
when the READY button is clicked.
▪ The DAP (Dose Area Product), Scan Time and Exposure Time will
be displayed below Patient Information window.

10. Guide the patient to the equipment.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 53


7. Acquiring PANO Images

7.3 Patient Positioning

▪ Have patience (especially pregnant women and children) wear a


lead apron to protect themselves from residual radiation.
▪ Be careful not to shine the laser beam directly into the person's
eyes. Doing so may result in vision loss.

▪ Correct posture reduces the shadow cast by the patient's cervical


spine and allows clear image acquisition.
▪ Metal implants or bridges may reduce the quality of the images.
▪ Be sure to adjust laser beam correctly. Otherwise, the quality of
images can be lower due to ghost images or expansion/reduction
of the images.

Getting prepared

1. Let the patient remove all the metal objects (glasses, earrings, hair pins, braces, false
teeth, etc.). Metal objects may induce ghost images and lower the image quality.
2. Have the patient wear a lead apron to protect themselves from residual radiation.
3. Use the Column UP/DOWN button or switch option to adjust the equipment to match
the height of the patient.
4. Press the Rotation test button in the Console program and check that the equipment
touches a part of the patient while the equipment is running.

▪ 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, ensure that the beams
and movement of the unit are not obstructed by the stool.

54 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

7.3.1 PANO Examination Mode (Standard / Right / Left / Front /


Orthogonal)

Normal Patient Positioning


1. Insert the Normal Bite into the Normal Chinrest and cover it with a Sanitary Vinyl Cover.

▪ The Sanitary Vinyl Cover is for single use only. It should be replaced
for each patient. Be sure to use the approved vinyl cover.

▪ Clean the Chinrest and the Bite with ethanol and wipe with a dry
towel before the next patient.

2. Loosen the Temple Supports OPEN/CLOSE Wheel under the control panel to widen
the Temple Supports.

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


4. Use the Column UP/DOWN button or switch option to adjust the height of the
equipment so that the patient's chin reaches the Chinrest.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 55


7. Acquiring PANO Images

5. Guide the patient to stand in the center of the equipment and direct them to remain in
the position outlined below.
 Hold the handles tightly.
 Press the chest against the equipment.
 Keep both feet close to the inside of the base.
 Keep both shoulders parallel.
 Straighten the Cervical Spine and stand still.
6. Let the patient bite the Bite along its grooves with his/her front teeth.

7. Let the patient maintain the posture as follows:


 Close the mouth.
 Place the tongue on the roof of the mouth.
 Close the eyes.

To acquire the best image possible, ask the patient not to:
- Breathe or swallow saliva during image acquisition
- Move during image acquisition

56 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

Edentulous Patient Positioning


1. Remove the Normal Chinrest and insert the Special Chinrest into the equipment.
2. Insert the Special Bite B into the Special Chinrest.

Clean the Chinrest and the Bite with ethanol and wipe with a dry towel
before the next patient.

3. Loosen the Temple Supports OPEN/CLOSE Wheel under the control panel to widen
the Temple Supports.

4. Guide the patient to the equipment.


5. Use the Column UP/DOWN button or switch option to adjust the height of the
equipment so that the patient's chin reaches the Chinrest.

6. Guide the patient to stand in the center of the equipment and direct them to remain in
the position outlined below.
 Hold the handles tightly.
 Press the chest against the equipment.
 Keep both feet close to the inside of the base.
 Keep both shoulders parallel.
 Straighten the Cervical Spine and stand still.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 57


7. Acquiring PANO Images

7. Let the patient maintain the posture as follows:


 Close the mouth.
 Place the tongue on the roof of the mouth.
 Close the eyes.

58 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

Laser Beam Aligning

Be careful not to shine the laser beam directly into the person's eyes.
Doing so may result in vision loss.

If the laser beam is not correctly positioned, there may be distortion,


causing the image to be enlarged or reduced, or ghost shadows may
occur and lower the image quality. Be sure to align the laser beam
properly.

▪ Three Laser Beams (Vertical Beam, Horizontal Beam, and Canine


Teeth Beam) will be activated when CONFIRM button is clicked.
- The Laser Beams are turned off automatically after 20 minutes or
when the READY button is clicked.)

▪ To turn the Laser beams on/off manually, click the icon on the

Control Panel of the Handle Frame or the icon on the


Console Software.

1. The Vertical Beam is fixed. Align the center of the patient’s face (Mid-sagittal Line) with
the Vertical Beam. (It’s to prevent horizontal expansion of the image)
2. Align the Horizontal Beam in a straight line to the Frankfurt Line on the patient's face.
Use the Horizontal Beam lever on the column (left side of the Control Panel) to
position it. Make sure that the Horizontal Beam is aligned to the patient's face
horizontally.

3. Direct the patient to smile and align the Canine Teeth Beam to the center of the
canines. Use the Canine Teeth Beam Lever (left side of the Control Panel) to adjust
the position of the beam.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 59


7. Acquiring PANO Images

Finishing Patient Positioning


1. After checking the positions of the patient and the laser beam, tighten the Temple
Supports OPEN/CLOSE Wheel under the control panel to prevent the patient's head
from moving.

2. Click the READY button on the Console Software. The X-ray exposure has not started
yet.

Make sure that the Temple Supports are in closed position before
clicking the READY button.

3. Now go to 7.4 X-ray Exposure to start the exposure.

60 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

7.3.2 SPECIAL Examination Mode (TMJ / Sinus)

<TMJ Open Mode (LAT / PA)>

The TMJ Close image can be acquired after the TMJ Open image is acquired.

Steps for TMJ Mode


Patient positioning for TMJ Open > Laser Beam Aligning > X-ray
Exposure > Patient positioning for TMJ Close > Laser Beam Aligning > X-
ray Exposure

Patient Positioning
1. Remove the Normal Chinrest and insert the Special Chinrest into the equipment.
2. Insert the Special Bite A into the Special Chinrest

Clean the Chinrest and the Bite with ethanol and wipe with a dry towel
before the next patient.

3. Loosen the Temple Supports OPEN/CLOSE Wheel under the control panel to widen
the Temple Supports.

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

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 61


7. Acquiring PANO Images

5. Use the Column UP/DOWN button or switch option to adjust the height of the
equipment so that the patient's chin reaches the Chinrest.

6. Guide the patient to stand in the center of the equipment and direct them to remain in
the position outlined below.
 Hold the handles tightly.
 Press the chest against the equipment.
 Keep both feet close to the inside of the base.
 Keep both shoulders parallel.
 Straighten the Cervical Spine and stand still.
7. Guide the patient to press the base of the nose (acanthion point) against the Chinrest
and tilt the head forward about 5˚. At this point, make sure the patient's jaw does not
touch the equipment.

▪ If the jaw touches the equipment it is difficult to maintain the proper


position to get good images.
▪ Be careful the patient does not to touch the equipment with his/her
jaw.

8. Let the patient maintain the posture as follows:


 Open the mouth.
 Place the tongue on the roof of the mouth.
 Close the eyes.

▪ As shown in the picture, the support unit of the integrated Chinrest


should touch the patient's acanthion point.
▪ Ask the patient to maintain his/her position until the operation is
completed.

62 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

Laser Beam Aligning

Be careful not to shine the laser beam directly into the person's eyes.
Doing so may result in vision loss.

If the laser beam is not correctly positioned there may be distortion,


causing the image to be enlarged or reduced, or ghost shadows may
occur and lower the image quality. Be sure to align the laser beam
properly.

▪ Three Laser Beams (Vertical Beam, Horizontal Beam, and Canine


Teeth Beam) will be activated when CONFIRM button is clicked.
- The Laser Beams are turned off automatically after 20 minutes or
when the READY button is clicked.)

▪ To turn the Laser beams on/off manually, click the icon on the

Control Panel of the Handle Frame or the icon on the


Console Software.

1. The Vertical Beam is fixed. Align the center of the patient’s face (Mid-sagittal Line) with
the Vertical Beam. (It’s to prevent horizontal expansion of the image)
2. Align the Horizontal Beam in a straight line to the Frankfurt Line on the patient's face.
Use the Horizontal Beam lever on the column (left side of the Control Panel) to
position it. Make sure that the Horizontal Beam is aligned to the patient's face
horizontally.

Finishing Patient Positioning


1. After checking the positions of the patient and the laser beam, tighten the Temple
Supports OPEN/CLOSE Wheel under the control panel to prevent the patient's head
from moving.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 63


7. Acquiring PANO Images

2. Click the READY button on the Console Software. The X-ray exposure has not started
yet.

Make sure that the Temple Supports are in closed position before
clicking the READY button.

3. Now go to 7.4 X-ray Exposure to start the exposure.

64 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

<TMJ Close Mode (LAT / PA)>


The TMJ Close image can be acquired after the TMJ Open image is acquired.

Steps for TMJ Mode


Patient positioning for TMJ Open > Laser Beam Aligning > X-ray
Exposure > Patient positioning for TMJ Close > Laser Beam Aligning > X-
ray Exposure

Patient Positioning
1. "Do you want to capture a TMJ Close image?" message will appear when the TMJ
Open mode is completed. Press/Click OK button to begin TMJ Close mode.

2. Guide the patient to the equipment.


3. Guide the patient to place the base of his/her nose (acanthion point) against the
Chinrest and bend the head forward about 5˚.
4. Let the patient maintain the posture as follows:
 Close the mouth.
 Place the tongue on the roof of the mouth.
 Close the eyes.

▪ As shown in the picture, the support unit of the integrated Chinrest


should touch the patient's acanthion point.
▪ Let the patient maintain his/her position until the operation is
completed.

.
Laser Beam Aligning
This is the same as the one for TMJ Open mode.

Finishing Patient Positioning


This is the same as the one for TMJ Open mode.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 65


7. Acquiring PANO Images

<Sinus Mode (LAT / PA)>


Patient Positioning
1. Remove the Normal Chinrest and insert the Special Chinrest into the equipment.
2. Insert the Special Bite A into the Special Chinrest

Clean the Chinrest and the Bite with ethanol and wipe with a dry towel
before the next patient.

3. Loosen the Temple Supports OPEN/CLOSE Wheel under the control panel to widen
the Temple Supports.

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


5. Use the Column UP/DOWN button or switch option to adjust the height of the
equipment so that the patient's chin reaches the Chinrest.

6. Guide the patient to stand in the center of the equipment and direct them to remain in
the position outlined below.
 Hold the handles tightly.
 Press the chest against the equipment.
 Keep both feet close to the inside of the base.
 Keep both shoulders parallel.
 Straighten the Cervical Spine and stand still.

66 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

7. Guide the patient to press the base of the nose (acanthion point) against the Chinrest
and tilt the head forward about 5˚. At this point, make sure the patient's jaw does not
touch the equipment.

▪ If the jaw touches the equipment it is difficult to maintain the proper


position to get good images.
▪ Be careful the patient does not to touch the equipment with his/her
jaw.

8. Let the patient maintain the posture as follows:


 Close the mouth.
 Place the tongue on the roof of the mouth.
 Close the eyes.

▪ As shown in the picture, the support unit of the integrated Chinrest


should touch the patient's acanthion point.
▪ Ask the patient to maintain his/her position until the operation is
completed.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 67


7. Acquiring PANO Images

Laser Beam Aligning

Be careful not to shine the laser beam directly into the person's eyes.
Doing so may result in vision loss.

If the laser beam is not correctly positioned, there may be distortion,


causing the image to be enlarged or reduced, or ghost shadows may
occur and lower the image quality. Be sure to align the Laser Beam
properly.

1. The Vertical Beam is fixed. Align the center of the patient’s face (Mid-sagittal Line) with
the Vertical Beam. (It’s to prevent horizontal expansion of the image)
2. Align the Horizontal Beam in a straight line to the Frankfurt Line on the patient's face.
Use the Horizontal Beam lever on the column (left side of the Control Panel) to
position it. Make sure that the Horizontal Beam is aligned to the patient's face
horizontally.

Finishing Patient Positioning


1. After checking the positions of the patient and the laser beam, tighten the Temple
Supports OPEN/CLOSE Wheel under the control panel to prevent the patient's head
from moving.

2. Click the READY button on the Console Software. The X-ray exposure has not started
yet.

Make sure that the Temple Supports are in closed position before
clicking the READY button.

3. Now go to 7.4 X-ray Exposure to start the exposure.

68 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

7.4 X-ray Exposure

▪ If an emergency occurs during image acquisition, release the


Exposure Switch to cease X-ray emission.
▪ The operator shall observe the X-ray safety regulations applicable
to his/her area always during the operation of this equipment.

▪ The operator must keep vocal/visual contact with the patient


always during image acquisition process.
▪ Do not operate the PC during exposure. Doing so may cause the
system to malfunction.

▪ Let the patient close the eyes during the operation.


▪ To acquire optimized images, instruct the patient to hold his/her
breath and not to swallow. Also, don’t let the patient move until the
Temple Supports are open.

1. Get out of the X-ray room and close the door.


2. Press and hold down the Exposure Switch until image acquisition is completed.

The image appears on the screen.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 69


7. Acquiring PANO Images

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


▪ The X-ray Exposure Indicator of the Exposure Switch and the LED
light on the top of the equipment turn yellow.
▪ An alert sound comes out to indicate that X-ray emission is
currently underway.
▪ On Console Software, the radiation mark turns yellow and “X-RAY”
changes to “X-RAY ON”.

3. Release the Exposure Switch when “Image capturing is completed” message


appears on the screen.

7.5 Finishing the Scan

1. Open the Temple Supports and guide the patient out of the equipment.
4. For Normal Bite, remove the Sanitary Vinyl Cover from the Bite.
5. Press READY button on the Console Software to bring the Rotating Unit back to its
initial position.

7.6 Checking the Captured Images

Acquired images can be reconstructed and converted to DICOM format.

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

▪ Refer to the EzDent-i / EasyDent User Manual for more


information.
▪ Please note that EzDent-i supports both PaX-i Plus and PaX-i
Insight while EasyDent supports PaX-i Plus only.

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


2. The images are automatically saved if automatic save option is configured as default. If
it is not configured as default, click Save button to save the images.
3. To check the image, double-click the one on the Patient List.

70 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


7. Acquiring PANO Images

Left blank intentionally

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 71


8. Acquiring CEPH Images (Optional)

8. Acquiring CEPH Images (Optional)


8.1 CEPH Imaging Program Overview
 Result Images

It provides conventional 2D cephalometric images.

 Image Acquisition Method

It acquires multiple images by scanning the specific oral & maxilocial regions with the
linear movement of the narrow detector and reconstructs them to a single 2D image
through computer calculations.

 Examination Programs

It is classified as below based on the ROI (Region of Interest).

Examination
Description Position
Area

▪ Used to study craniofacial disease, trauma,


and congenital malformation and examine
the soft tissue in the otorhinolaryngological
area, the sinus, and the hard palate.
Lateral / ▪ Measures the angles formed by the <Lateral>
Full Lateral connecting lines between the cranial
measurement points to further assess the
growth of the facial region. It's widely used in
Orthodontics and Oral and Maxillofacial
Surgery.
<Full Lateral>

▪ The radiation is directed from the posterior of


the skull to the anterior.
▪ Used to examine cranial diseases, trauma,
and congenital malformations.
▪ Used to assess the growth of lateral side of
the face. It is also used to examine the
ramus mandibulae, the posterior region of
the third largest molar in the lower jaw, the
PA sidewall of the maxillary sinus, the frontal
sinus, antrum ethmoidale, olfactory pits and
optic disc pits.
▪ Measures the angles formed by the <PA>
connecting lines between the cranial
measurement points to further assess the
growth of the facial region. It is widely used
in Orthodontics and Oral and Maxillofacial
Surgery.

72 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

Examination
Description Position
Area
▪ Used to study the base of the skull,
horizontal angulation of the mandibular
condylar axis, the sphenoid sinus, the
curvature of the lower jaw, the side wall of
SMV
the maxillary sinus, and zygomatic arch
fractures. Also used to study the inner and
outer alar plates and holes at the base of the
skull. <SMV>

▪ Used to study the frontal sinus, the antrum


ethmoidale, the optic disc pit, the
Waters’ view frontozygomatic suture, the nasal cavity, the
coronoid process between the upper jaw and
the zygomatic arch.

<Waters’ view>

▪ Used to assess hand bone age to compare


Carpus
the changes in the skull.

<Carpus>

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 73


8. Acquiring CEPH Images (Optional)

8.2 Configuring Exposure Parameters

To acquire CEPH images, 6. Getting Started must be completed first.

You can set the imaging parameters on the Console Software running
on the PC. They are synchronized and display the same environmental
settings.

1. Click CEPH button on the Main Screen.

74 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.

2. Select an Image Option.

Mode Description
Normal Normal quality image
Fast (Default) Low dose image

3. Select an examination program in the CEPH Examination panel.

4. The Gender / Age group of the patient is selected automatically based on the patient
information. If necessary, you can select the option manually.

5. Select X-ray intensity.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 75


8. Acquiring CEPH Images (Optional)

Depending on the circumference of the patient’s head, X-ray intensity


may be classified as Hard, Normal, or Soft:
Soft ≤ Normal ≤ Hard

6. The values of tube voltage and current are configured automatically according to the
patient's gender/age group and X-ray intensity. Click the UP/DOWN arrow to adjust
kVp and mA. The dose is adjustable by ±1 kVp and ±1 mA respectively.

7. Click CONFIRM button when exposure parameter setting is completed.

When you click CONFIRM button,


▪ The READY button will be activated. (This means that the equipment
is ready for X-ray exposure.)
▪ The DAP (Dose Area Product), Scan Time and Exposure Time will
be displayed below Patient Information window.

8. Guide the patient to the equipment.

76 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

8.3 Patient Positioning

▪ Have patience (especially pregnant women and children) wear a


lead apron to protect themselves from residual radiation.
▪ Be careful not to shine the laser beam directly into the person's
eyes. Doing so may result in vision loss.

Ensure that the Nasal Positioner is left unfolded, before adjusting the
Ear Rods in the proper direction.

▪ Correct posture reduces the shadow cast by the patient's cervical


spine and allows clear image acquisition.
▪ Metal implants or bridges may reduce the quality of the images.

Getting prepared

1. Let the patient remove all the metal objects (glasses, earrings, hair pins, braces, false
teeth, etc.). Metal objects may induce ghost images and lower the image quality.
2. Have the patient wear a lead apron to protect themselves from residual radiation.
3. Use the Column UP/DOWN button or switch option to adjust the equipment to match
the height of the patient.

▪ 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, ensure that the beams
and movement of the unit are not obstructed by the stool.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 77


8. Acquiring CEPH Images (Optional)

8.3.1 Lateral / Full Lateral Mode

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

Patient Positioning
1. Turn the Nasal Positioner to the Lateral mode Positioning Marker as shown below.

2. Leave enough space between the Ear Rods.

Use the Porion Position Reference Indicator that appears in the acquired
image to easily confirm the location of Porion.

3. Guide the patient to the CEPH unit.


4. Direct the patient to relax his/her neck and shoulders and stand upright.
5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH
unit to approximately match the height of the patient.

After adjusting the height of the column, align the Ear Rods and Nasal
Positioner to the patient.

78 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

6. Align the Ear Rods to the patient’s ears properly so that the head does not move
during the operation. And align the Nasal Positioner to the patient’s nation by adjusting
its height.

7. Align horizontally so the patient's Frankfurt Line is parallel to the floor.

8. Direct the patient to swallow first before closing the mouth and to remain in his/her
current position until image acquisition is completed.
9. Click the READY button on Console Software. No X-ray will be emitted at this point.
10. Now go to 8.4 X-ray Exposure to start the exposure.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 79


8. Acquiring CEPH Images (Optional)

8.3.2 PA Mode

Patient Positioning
1. Turn the Nasal Positioner to the PA / Waters’ view / Carpus mode Positioning Marker
as shown below.

2. Fold the Nasal Positioner up. The Nasal Positioner is not used in PA mode.
3. Guide the patient to the CEPH unit.
4. Ask the patient to stand upright facing the sensor. Make sure that the patient’s
shoulders are level and that his/her neck is relaxed.

80 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH
unit to approximately match the height of the patient.

After adjusting the height of the column, align the Ear Rods to the
patient.

6. During the operation, properly align the Ear Rods to the patient's ears so his/her head
does not move.
7. Align horizontally so the patient's Frankfurt Line is parallel to the floor.

8. Direct the patient to swallow first before closing his/her mouth and to remain in his/her
current position until image acquisition is completed.
9. Click the READY button on Console Software. No X-ray will be emitted at this point.
10. Now go to 8.4 X-ray Exposure to start the exposure.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 81


8. Acquiring CEPH Images (Optional)

8.3.3 SMV Mode

Patient Positioning
1. Turn the Nasal Positioner to the SMV mode Positioning Marker as shown below.

2. Fold the Nasal Positioner up. The Nasal Positioner is not used in SMV mode.
3. Guide the patient to the CEPH unit.
4. Guide the patient to face the X-ray tube and stand upright.

82 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH
unit to approximately match the height of the patient.

After adjusting the height of the column, align the Ear Rods to the
patient.

6. During the operation, properly align the Ear Rods to the patient's ears so his/her head
does not move.
7. Carefully tilt the patient's head back and adjust so his/her Frankfurt Line is vertical with
the floor.
8. Direct the patient to swallow first before closing his/her mouth and to remain in his/her
current position until image acquisition is completed.

9. Click the READY button on Console Software. No X-ray will be emitted at this point.
10. Now go to 8.4 X-ray Exposure to start the exposure.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 83


8. Acquiring CEPH Images (Optional)

8.3.4 Waters’ view Mode

Patient Positioning
1. Turn the Nasal Positioner to the PA / Waters’ view / Carpus mode Positioning Marker
as shown below.

2. Fold the Nasal Positioner up. The Nasal Positioner is not used in Waters’ view mode.
3. Guide the patient to the CEPH unit.
4. Ask the patient to stand upright facing the sensor. Make sure that the patient’s
shoulders are level and that his/her neck is relaxed.
5. Use the Column UP/DOWN button or switch option to adjust the height of the CEPH
unit to approximately match the height of the patient.

After adjusting the height of the column, align the Ear Rods to the
patient.

6. During the operation, properly align the Ear Rods to the patient's ears so his/her head
does not move.
7. Direct the patient to swallow first before closing his/her mouth, and guide the patient to
bend the head backward 30˚ - 40˚. Direct the patient to remain in the current position
until image acquisition is completed.

8. Click the READY button on Console Software. No X-ray will be emitted at this point.
9. Now go to 8.4 X-ray Exposure to start the exposure.

84 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

8.3.5 Carpus Mode

For Carpus Mode, install the Carpus Plate first before positioning the patient.

Installing the Carpus Plate

1. Turn the Nasal Positioner to the PA / Waters’ view / Carpus mode Positioning Marker
as shown below.

2. Fold the Nasal Positioner up. The Nasal Positioner is not used in Carpus mode.
3. Fit the two ends of the Carpus Plate into the two holes of the CEPH unit as below.

4. Confirm that the Carpus Plate is safely mounted.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 85


8. Acquiring CEPH Images (Optional)

Patient Positioning

1. Let the patient put his/her right hand splayed on the Carpus Plate as shown below.
Make sure that the patient does not bend his/her fingers.

2. Ask the patient to close his/her eyes and stand still until the image acquisition is
completed.
3. Click the READY button on Console Software. No X-ray will be emitted at this point.
4. Now go to 8.4 X-ray Exposure to start the exposure.

86 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

8.4 X-ray Exposure

▪ If an emergency occurs during image acquisition, release the


Exposure Switch to cease X-ray emission.
▪ The operator shall observe the X-ray safety regulations applicable
to his/her area always during the operation of this equipment.

▪ The operator must keep vocal/visual contact with the patient


always during image acquisition process.
▪ Do not operate the PC during exposure. Doing so may cause the
system to malfunction.

▪ Let the patient close the eyes during the operation.


▪ To acquire optimized images, instruct the patient to hold his/her
breath and not to swallow.

1. Get out of the X-ray room and close the door.


2. Press and hold down the Exposure Switch until image acquisition is completed.

The image appears on the screen.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 87


8. Acquiring CEPH Images (Optional)

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


▪ The X-ray Exposure Indicator of the Exposure Switch and the LED
light on the top of the equipment turn yellow.
▪ An alert sound comes out to indicate that X-ray emission is
currently underway.
▪ On Console Software, the radiation mark turns yellow and “X-RAY”
changes to “X-RAY ON”.

3. Release the Exposure Switch when “Image capturing is completed” message


appears on the screen.

8.5 Finishing the Scan

1. Leave enough space between the Ear Rods.


2. Fold the Nasal Positioner up in case it’s unfolded.
3. Guide the patient out of the equipment.

8.6 Checking the Captured Images

Acquired images can be reconstructed and converted to DICOM format.

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

▪ Refer to the EzDent-i / EasyDent User Manual for more


information.
▪ Please note that EzDent-i supports both PaX-i Plus and PaX-i
Insight while EasyDent supports PaX-i Plus only.

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


2. The images are automatically saved if automatic save option is configured as default. If
it is not configured as default, click Save button to save the images.
3. To check the image, double-click the one on the Patient List.

88 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


8. Acquiring CEPH Images (Optional)

Left blank intentionally

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 89


9. Acquiring 3D PHOTO Images (Optional)

9. Acquiring 3D PHOTO Images (Optional)


9.1 3D PHOTO Imaging Program Overview
 Result Images

It provides 3D PHOTO images

 Image Acquisition Module

A separate Intel Sense SDK module utilizing a 3D PHOTO camera is used.

 Scan Area

It covers the surface of the face.

 Available Programs

It is classified as below.

Mode Description
Captures both 3D PHOTO images and CEPH Lateral
3D PHOTO + Lateral
images.

3D PHOTO Captures 3D PHOTO images only.

3D PHOTO images themselves have no diagnostic purposes. But they


can be used for consultation or reference purposes such as before-
surgery simulation by mapping them on CEPH images in the same
position.

90 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


9. Acquiring 3D PHOTO Images (Optional)

9.2 Taking 3D PHOTOs


To acquire 3D PHOTO Images, 6. Getting Started must be completed first.

You can set the imaging parameters on Console Software running on


the PC. Touch Screen and Console Software are synchronized and
display the same environmental settings.

9.2.1 3D PHOTO + Lateral Mode

1. Click 3D PHOTO button on the Main Screen.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 91


9. Acquiring 3D PHOTO Images (Optional)

“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.

2. Select 3D PHOTO+Lateral mode.

The steps from No. 3 to No. 7 listed below are for parameter settings
for CEPH (Lateral mode) image acquisition.

3. The Gender / Age group of the patient is selected automatically based on the patient
information. If necessary, you can select the option manually.

4. Select X-ray intensity.

Depending on the circumference of the patient’s head, X-ray intensity may be


classified as Hard, Normal, or Soft:
Soft ≤ Normal ≤ Hard

92 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


9. Acquiring 3D PHOTO Images (Optional)

5. The values of tube voltage and current are configured automatically according to the
patient's gender/age group and X-ray intensity. Click the UP/DOWN arrow to adjust
kVp and mA. The dose is adjustable by ±1 kVp and ±1 mA respectively.

6. Click CONFIRM button when exposure parameter setting is completed.

When you click CONFIRM button,


▪ The 3D PHOTO Camera and the Rotating Unit will move to its initial
scanning position.
▪ The DAP, Scan Time and Exposure Time will be displayed below
Patient Information window.

7. Guide the patient to the equipment and conduct patient positioning for CEPH Lateral.
(Conduct the steps from No.1 to No.8 on 8.3.1 Lateral / Full Lateral Mode.)

In “3D PHOTO + Lateral” mode, you don’t need to click the READY
button after patient positioning is completed.

8. After completing patient positioning, fold the Nasal Positioner up.


9. Guide the patient to remain in a comfortable posture and look toward.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 93


9. Acquiring 3D PHOTO Images (Optional)

10. You can see the patient through the Image Preview Window or Touch Screen.
 Make sure that the horizontal lines displayed on the screen are parallel to the
patient’s nasal base.
 If necessary, click or press LED lamp UP/DOWN button to adjust the brightness
to have proper lighting for the photograph.

11. Click 3D Scan button when ready.

▪ When you click the 3D Scan button, the 3D PHOTO Camera will
rotate the patient’s head and take the photos.
▪ Guide the patient not to follow the movement of the 3D PHOTO
Camera while taking 3D PHOTOs. The patient needs to stay looking
forward to the image acquisition is completed.

12. After completing 3D PHOTO acquisition, go to 8.4 X-ray Exposure to start the
exposure for CEPH image acquisition.

94 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


9. Acquiring 3D PHOTO Images (Optional)

9.2.2 3D PHOTO Mode

1. Click 3D PHOTO button on the Main Screen.

“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 95


9. Acquiring 3D PHOTO Images (Optional)

2. Select 3D PHOTO mode.

3. Guide the patient to stand in the center of the CEPH unit and direct him/ her to remain
in a comfortable posture and look toward the 3D PHOTO camera.
4. After completing patient positioning, fold the Nasal Positioner up.
5. Guide the patient to remain in a comfortable posture and look toward.
6. You can see the patient through the Image Preview Window or Touch Screen.
 Make sure that the horizontal lines displayed on the screen are parallel to the
patient’s nasal base.
 If necessary, click or press LED lamp UP/DOWN button to adjust the brightness
to have proper lighting for the photograph.

7. Click 3D Scan button when ready.

▪ When you click the 3D Scan button, the 3D PHOTO Camera will
rotate the patient’s head and take the photos.
▪ Guide the patient not to follow the movement of the 3D PHOTO
Camera while taking 3D PHOTOs. The patient needs to stay looking
forward to the image acquisition is completed.

8. Guide the patient out of the equipment.

96 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


9. Acquiring 3D PHOTO Images (Optional)

9.3 Checking 3D PHOTOs

1. The images are transferred to EzDent-i / EasyDent automatically when the image
capturing is completed.
2. Double-click the image to confirm the Patient List.
3. You can check the captured image (.OBJ file) with a 3rd party 3D PHOTO viewer after
exporting the image from EzDent-i / EasyDent.

▪ Use a 3rd party 3D Photo Viewer.


▪ Refer to the EzDent-i / EasyDent and 3rd party 3D PHOTO
viewer User Manual for more information.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 97


10. Troubleshooting

10. Troubleshooting
10.1 Troubleshooting
If a problem occurs while operating the equipment, perform the corresponding
troubleshooting measures outlined in the table below. If the problem persists, please
contact our customer support staff.

If the equipment is not working

Cause Actions to be taken


Failure of power supply Check the equipment’s power supply.
Initialization status Wait until the equipment has been initialized and then
try again.
Failure of the Control Check the connection status of Communication Port
PC's connection (Optic) which connects the PC to the equipment.

If the Exposure Switch is not functioning

Cause Actions to be taken


Failure of readiness Check whether the Console Software is ready for
imaging.

If imaging cannot be performed

Cause Actions to be taken


Failure of initialization Wait until the equipment is initialized and then try again.
If this problem persists, restart the equipment.

If the Laser Beam has shut off and patient positioning cannot be performed

Cause Actions to be taken


Expiration of the time Press the Laser Beam button to turn on the Laser
allotted for patient Beam.
positioning

98 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


10. Troubleshooting

10.2 Error Codes


In instances of abnormal operation, error messages will be displayed with error codes
on the Console Software and Control Panel. If a problem persists, please request
assistance from the customer support information services.

Error Code Description


H001 Error occurs when the tube state is not Ready.
- Check the inverter board and such for CAN communication
cable connections.
H002 Error occurs by disconnection of the cables for the monoblock
and the inverter board.
- Check the cables to the inverter and the monotank.
H003 Error occurs by overcurrent of the inverter (upon X-ray
emission).
- Check the input power (DC 300 V) of the inverter board.
- After replacing the inverter board, check for error after X-ray
emission. If the same error occurs, replace the monotank.
H008 Error occurs when the temperature of the monoblock is greater
than or equal to the set value. When the temperature is less than
or equal to the set value of -2 °C, the error is cleared.
- Check the temperature of the monotank.
- When the temperature of the monotank is greater than or equal
to 55 °C, do not emit X-rays and cool down the monotank before
use.
H009 Error occurs when the inverter current has a problem during
emission of X-rays (greater than or equal to the X-ray irradiation
current by +1 A under the current EP and IP).
- Check the input power (DC 300 V) of the inverter board.
H010 Error occurs when the Exposure Switch is "Off" after the
exposure On command is sent.
- Check the connection to the X-ray switch on the inverter.
- Check for CAN communication status.
- If there is any communication failure, replace the inverter
board.
H011 Error occurs when exposure Off command is not received within
0.5 seconds after the Exposure Switch is changed to Off during
X-ray emission.
- Check the connection to the X-ray switch on the inverter.
- Check for CAN communication status.
- If there is any communication failure, replace the inverter
board.
H012 Error occurs when the kV feedback is less than or equal to the
set value by more than or equal to 20 kV during X-ray emission.
(kV feedback ≤ set value - 20) The number "3" appears on the
inverter board.
- Check the input power (DC 300 V) of the inverter board.
- Check that the input power (DC 300 V) is changed to less than
PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 99
10. Troubleshooting

Error Code Description


or equal to 200 V upon X-ray emission. (In case of less than or
equal to 200 V, replace the power source.)
- After replacing the inverter board, check for error after X-ray
emission. If the same error occurs, replace the monotank.
H013 Error occurs when the kV feedback is greater than or equal to
the set value by more than or equal to 20 kV during X-ray
emission (kV feedback ≥ set value + 20). The number "4"
appears on the inverter board.
- After emitting X-rays again, check whether the same error
occurs.
- Check the input power (DC 300 V) of the inverter board.
- Check that the input power (DC 300 V) is changed to less than
200 V upon X-ray emission. (In case of less than 200 V, replace
the power source.)
- After replacing the inverter board, check for error after X-ray
emission. If the same error occurs, replace the monotank.
H014 Error occurs when the mA feedback is less than or equal to the
50 % of the set value during X-ray emission (mA feedback ≤ set
value x 0.5). The number "6" appears on the inverter board.
- After emitting X-rays again, check whether the same error
occurs.
- Check the input power (DC 300 V) of the inverter board.
- After replacing the inverter board, check for error after X-ray
emission. If the same error occurs, replace the monotank.
H015 Error occurs when the mA feedback is greater than or equal to
the 150 % of the set value during X-ray emission (mA feedback
≥ set value x 1.5). The number "6" appears on the inverter
board.
- After emitting X-rays again, check whether the same error
occurs.
- Check the input power (DC 300 V) of the inverter board.
- After replacing the inverter board, check for error after X-ray
emission. If the same error occurs, replace the monotank.
H020 Error occurs during movement from the P-axis motor's origin
position.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H021 Error occurs during movement from the rotator-axis motor's
origin position.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H026 Error occurs during movement of the Cephalo secondary
collimator motor's origin position.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H027 Error occurs during movement from the Cephalo sensor motor's
origin position.

100 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


10. Troubleshooting

Error Code Description


- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H036 Error occurs during movement from the 1-axis collimator's
left/right origin position.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H037 Error occurs during the generator tilting motion.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H038 Error occurs during the temple support motor's motion.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H039 Error occurs during the movement from the X-axis motor's origin
position.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H040 Error occurs during the movement from the Y-axis motor's origin
position.
- Check the connection lines for motor and origin sensor. If any
problem, replace the motor or sensor.
H060 Error occurs when the Exposure Switch has been pressed when
the equipment is turned on.
- Check the connection to the Exposure Switch and perform
Reset the equipment.
H102 Error occurs when there is no response to CAN communication.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 101


11. Cleaning and Maintenance

11. Cleaning and Maintenance

The equipment must be installed and maintained on a flat surface.

11.1 Cleaning

Always turn off the power to the equipment and disconnect it from the
power outlet before cleaning.

▪ Thoroughly clean the areas of the equipment that come in direct contact with the
patient, such as the Chinrest and the Bite.

▪ Do not use spray cleaners or solvents as they could flow into the equipment and
damage the electrical components or cause a fire.

▪ Do not use abrasive liquids such as acetone, gas, or oil, which may cause
corrosion on the surface of the equipment.

▪ Do not use any cleaning products which contain silicon. They could potentially
damage the equipment’s electrical components.

The following table summarizes the standard cleaning procedures to be performed by


the operator.

Components Cleaning Process


Bite
Clean with ethanol and gently wipe with a dry
(Normal Bite, Special Bite A, towel before the next patient.
and Special Bite B)
Temple Supports Clean with ethanol and gently wipe with a dry
towel before the next patient.
Chinrest Clean with ethanol and gently wipe with a dry
towel before the next patient.
Computer and peripherals Follow the manufacturers’ instructions found in the
accompanying manuals.
Outer covers of equipment Wipe the unit with a dry cloth at the end of each
day.

Do not use cleaning agents in aerosol or spray form directly on the


surface of the equipment.

102 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


11. Cleaning and Maintenance

11.2 Maintenance
VATECH requires periodic constancy tests to ensure image quality and the safety of
the patient and the operator.

Only VATECH-authorized technicians can perform inspection and service for the
equipment. For technical assistance, contact VATECH service center or your local
VATECH representative.

11.2.1 Maintenance Task Checklist

Tasks Period
Before the operation, ensure that the equipment is clean and ready for
use. Make sure that all parts that come in direct contact with the patient Daily
have been cleaned thoroughly.
After using the equipment, make sure that the Main Power Switch has
Daily
been turned off.
Ensure that the equipment is firmly plugged into a dedicated power
Daily
source.
Ensure that the plug and the power cord are not heated abnormally. Daily
Confirm that the LED indicator turns yellow when the Exposure Switch
is pressed. Ensure that the LED indicator remains yellow for the entire Daily
duration of the exposure.
Ensure that the power cable is not kinked, broken, exposed and free of
Daily
all other defects.
Confirm that activating the Emergency Stop Switch ceases the unit’s
operation. Pressing the Emergency Stop Switch should stop all Weekly
movement of the equipment and X-ray emission.
Ensure that all visible labels are intact and legible. Weekly
Check for possible damages to the Exposure Switch cable. Monthly
Confirm that the audio message is audible throughout the duration of
Monthly
the exposure.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 103


12. Disposing of the Equipment

12. Disposing of the Equipment


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 the X-ray tube, are environment-friendly and can be recycled.

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

Hazardous
To the special waste; Needs
Parts Materials Recyclable
disposal site Separate
Collection
Frame and Aluminum

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 ●

This dental equipment shall not be disposed of as domestic garbage


materials.

Clean / Disinfect / Sterilize the equipment before disassembling it and


disposing of its parts.

Observe all regulations relevant to the disposal of waste in your


country.

104 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


12. Disposing of the Equipment

Left blank intentionally

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 105


13. Technical Specifications

13. Technical Specifications


13.1 Mechanical Specifications

13.1.1 Dimensions (unit = mm)

With CEPH Unit Without CEPH Unit

106 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


13. Technical Specifications

Item Description

Without CEPH 95 kg (209.4 lbs. – without Base)


unit 135 kg (297.6 lbs. – with Base)
Weight
120 kg (264.5 lbs. - without Base)
With CEPH unit
160 kg (352.7 lbs. - with Base)
Without Base Max. 2272 mm
Total Height
With Base Max. 2300 mm
990 mm (L) x 1200 mm (W) x 2272 mm
Without CEPH (H) (without Base)
Dimensions during unit 990 mm (L) x 1200 mm (W) x 2300 mm
operation (H) (with Base)
(Length x Width x 1910 mm (L) x 1200 mm (W) x 2272 mm
Height) (H) (without Base)
With CEPH unit
1910 mm (L) x 1200 mm (W) x 2300 mm
(H) (with Base)
Rotating Unit Vertical Movement Max. 700mm
Base Stand / Wall Mount
Installation type
(Default: Wall Mount type)
Main Box, CEPH Box (Optional), Base
Packing Box Organization
Box (Optional)

13.1.2 Image Magnification

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

PANO 490.3 375.5 114.6 1 : 1.3

CEPH 1745 1524 221 1 : 1.14

▪ FDD: Focal Spot to Detector Distance


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

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 107


13. Technical Specifications

13.2 Technical Specifications


13.2.1 X-ray Generator Specifications
Specifications

Item Description
Model DG-07D21T2
Rated output power 1.0 kW
Inverter model
INV-21
name
Type Inverter

Normal/ kVp 60 kV ~ 99 kV (1 kV increment)


Generator Pulse mA 4 mA ~ 10 mA (1 mA increment)

Air Cooling / Protect ≥ 60℃


Cooling 1:60 or more (Exposure time: interval
time)

Total filtration Min. 2.5 mm Al


Added filtration 1.5 mm Al (Fixed)
Manufacturer Toshiba
Model D-052SB (Stationary Anode type)
Focal spot size 0.5 mm x 0.5 mm (IEC 60336)
Target Angle 5 degrees
Tube Inherent Filtration At least 0.8 mm Al equivalent at 50 kV
X-ray Coverage 95 mm x 380 mm at SID 550 mm
Anode Heat
35 kJ
Content
1:60 or more
Duty Cycle
(Exposure time: Interval time)

108 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


13. Technical Specifications

Test Condition

Mode Tube Voltage (kVp) Tube Current (mA) Exposure Time (s)

60 ~ 99 4 ~ 10 20.2

60 ~ 99 4 ~ 10 17.2

60 ~ 99 4 ~ 10 16.7

60 ~ 99 4 ~ 10 14.5

60 ~ 99 4 ~ 10 13.8

60 ~ 99 4 ~ 10 13.5

60 ~ 99 4 ~ 10 11.5

60 ~ 99 4 ~ 10 11.2

60 ~ 99 4 ~ 10 11.1

60 ~ 99 4 ~ 10 10.3

60 ~ 99 4 ~ 10 10.1

60 ~ 99 4 ~ 10 9.7

60 ~ 99 4 ~ 10 9.2

PANO 60 ~ 99 4 ~ 10 8.6

60 ~ 99 4 ~ 10 8.4

60 ~ 99 4 ~ 10 7.3

60 ~ 99 4 ~ 10 7.2

60 ~ 99 4 ~ 10 6.8

60 ~ 99 4 ~ 10 6.7

60 ~ 99 4 ~ 10 6.2

60 ~ 99 4 ~ 10 6.1

60 ~ 99 4 ~ 10 6.0

60 ~ 99 4 ~ 10 5.9

60 ~ 99 4 ~ 10 5.7

60 ~ 99 4 ~ 10 5.2

60 ~ 99 4 ~ 10 5.1

60 ~ 99 4 ~ 10 5.0

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 109


13. Technical Specifications

Mode Tube Voltage (kVp) Tube Current (mA) Exposure Time (s)

60 ~ 99 4 ~ 10 4.9

60 ~ 99 4 ~ 10 4.8

60 ~ 99 4 ~ 10 4.3

60 ~ 99 4 ~ 10 3.7

60 ~ 99 4 ~ 10 3.6

60 ~ 99 4 ~ 10 3.1

60 ~ 99 4 ~ 10 2.6

60 ~ 99 4 ~ 10 2.5

60 ~ 99 4 ~ 10 1.8

60 ~ 99 4 ~ 10 1.3

60 ~ 99 4 ~ 10 1.9

60 ~ 99 4 ~ 10 2.4

CEPH 60 ~ 99 4 ~ 10 3.9

60 ~ 99 4 ~ 10 4.9

60 ~ 99 4 ~ 10 5.4

110 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


13. Technical Specifications

❚❚ Maximum Rating Charts

❚❚ Emission & Filament Characteristics

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 111


13. Technical Specifications

❚❚ Anode Thermal Characteristics

❚❚ X-ray Tube Assembly Heating / Cooling Curve

112 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


13. Technical Specifications

13.2.2 Detector Specifications

ENGLISH
 PaX-i Plus

Description
Item
PANO CEPH
Model Xmaru1501CF-PLUS Xmaru2602CF

Detector Type CMOS photodiode array

Pixel size 100 m @ Full Resolution 200 m @ 2X2 Binning

Active area 151.2 mm x 6.0 mm 259.2 mm x 15.6 mm

Frame Rate ~ 287 Hz @ Full Resolution ~ 330 Hz @ 2x2 binning

Analogue-Digital
14 bits
Conversion

Operating Condition 10 ~ 35 ℃ (Temperature) / 10 ~ 75 % (Humidity)

Storage Condition -10 ~ 60 ℃ (Temperature) / 10 ~ 75 % (Humidity)

174 (W) x 79 (L) x 30.2 (H) 279 (W) x 110 (L) x 20 (H)
Sensor size
mm mm

Sensor Weight 0.45 Kg 1.3 Kg

Converter Csl:Ti

Energy Range 50 - 120 kVp

Readout Charge amplifier array

Video Output Optic

> 55 % @ 1 lp/mm > 35 % @ 1 lp/mm


MTF
> 13 % @ 2.5 lp/mm > 5% @ 2.5 lp/mm

DQE > 70 % @ 0 lp/mm > 60 % @ 0 lp/mm

Dynamic Range ≥ 70dB ≥ 70dB

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 113


13. Technical Specifications

 PaX-i Insight

Description
Item
PANO CEPH
Model Xmaru1404CF-PLUS Xmaru2602CF

Detector Type CMOS photodiode array

Pixel size 198 m @ 4X4 Binning 200 m @ 2X2 Binning


Active area 135.8 mm x 36.4 mm 259.2 mm x 15.6 mm

Frame Rate ~ 308 Hz @ 4x4 binning ~ 330 Hz @ 2x2 binning

Analogue-Digital
14 bits
Conversion

Operating condition 10 ~ 35 ℃ (Temperature) / 10 ~ 75 % (Humidity)

Storage condition -10 ~ 60 ℃ (Temperature) / 10 ~ 75 % (Humidity)


230 (W) x 160 (L) x 26 (H) 279 (W) x 110 (L) x 20 (H)
Sensor size
mm mm
Sensor weight 1.5Kg 1.3Kg

Converter Csl:Ti

Energy Range 50 – 120 kVp

Readout Charge amplifier array

Video Output Optic

> 45% @ 1 lp/mm >35% @1 lp/mm


MTF
> 8% @ 2.5lp/mm >5% @ 2.5 lp/mm

DQE > 60% @ ~0lp/mm > 60% @ ~0lp/mm

Dynamic Range > 80dB ≥70dB

114 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


13. Technical Specifications

13.3 Electrical Specifications

ENGLISH
Item Description
Power supply voltage 100 - 240 V ~
Frequency 50 / 60 Hz
Power rating 1.3 kVA
Tube Voltage (kVp) ± 10 %
Accuracy Tube Current (mA) ± 20 %
Exposure Time (s) ± (5 % + 50 ms)

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

▪ Allowable input voltage fluctuation requirement: ±10 %.

▪ Mode of operation: Continuous operation with intermittent loading - Needs waiting


time (at least 60 times the exposure time) before next exposure begins.

▪ Column operation time: Max. 2 min. On / 18 min. Off (Ratio 1:9)

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 115


13. Technical Specifications

▪ To assure line voltage quality, a separate 3-core grounded power


cable connected directly to central distribution panel with an over-
current circuit breaker rated for 20A must be used.
▪ Maximally allowed deviation of the tube voltage / tube current /
exposure time:
Tube Voltage (kVp) ± 10 % / Tube Current (mA) ± 20 % / Exposure
Time (s) ± (5 % + 50 ms) according to IEC 60601-2-63.
▪ The mains resistance should not exceed 0.045 ohms at 100 V and
0.19 ohm at 240 V.

13.4 Environmental Specifications

Item Description
Temperature 10 ~ 35 ℃

During Operation Relative humidity 30 ~ 75 %

Atmospheric pressure 860 ~ 1060 hPa

Temperature -10 ~ 60 ℃
During Transport
Relative humidity 10 ~ 75 %
and Storage
Atmospheric pressure 860 ~ 1060 hPa

116 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


13. Technical Specifications

Left blank intentionally

ENGLISH

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 117


14. Appendices

14. Appendices
14.1 Recommended X-ray Exposure Tables
14.1.1 PANO Mode
Exposure Condition

 PANO Option > Normal

Tube Tube
Gender / X-ray
Mode Image Option Voltage Current
Age group Intensity
(kVp) (mA)

Hard 74 9

Man Normal 73 9

Soft 72 9

Hard 73 9
UHD (Optional) /
Woman Normal 72 9
HD
Soft 71 9

Hard 68 9

Child Normal 67 9

PANO Soft 66 9

Examination Hard 74 7

Man Normal 73 7

Soft 72 7

Hard 73 7

Normal Woman Normal 72 7

Soft 71 7

Hard 68 7

Child Normal 67 7

Soft 66 7

Hard 74 9
SPECIAL
N/A Man Normal 73 9
Examination
Soft 72 9

118 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

Tube Tube
Gender / X-ray

ENGLISH
Mode Image Option Voltage Current
Age group Intensity
(kVp) (mA)

Hard 73 9

Woman Normal 72 9

Soft 71 9

Hard 68 9

Child Normal 67 9

Soft 66 9

 PANO Option > Auto Focusing (Optional)

Tube Tube
Gender / X-ray
Mode Image Option Voltage Current
Age group Intensity
(kVp) (mA)

Hard 74 9

Man Normal 73 9

Soft 72 9

Hard 73 9
UHD (Optional) /
Woman Normal 72 9
HD
Soft 71 9

Hard 68 9

Child Normal 67 9
PANO
Soft 66 9
Examination
Hard 74 7

Man Normal 73 7

Soft 72 7

Hard 73 7
Normal
Woman Normal 72 7

Soft 71 7

Hard 68 7
Child
Normal 67 7

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 119


14. Appendices

Tube Tube
Gender / X-ray
Mode Image Option Voltage Current
Age group Intensity
(kVp) (mA)

Soft 66 7

▪ Auto Focusing is not available for SPECIAL Examination programs.

 PANO Option > Insight PAN (PaX-i Insight only)

Tube Tube
Gender / X-ray
Mode Image Option Voltage Current
Age group Intensity
(kVp) (mA)

Hard 71 5

Man Normal 70 5

Soft 69 5
PANO
Hard 71 5
Examination /
N/A Woman Normal 70 5
SPECIAL
Soft 69 5
Examination
Hard 68 5

Child Normal 67 5

Soft 66 5

120 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

Scan Time / Exposure Time

ENGLISH
 PANO Examination

Image Option

UHD (Optional) HD Normal


Arch Examination
Scan Exposure Scan Exposure Scan Exposure
Type Mode
Time Time Time Time Time Time

(s) (s) (s) (s) (s) (s)

Standard 21.0 20.2 14.0 13.5 10.4 10.1

Right 21.0 10.1 14.0 6.7 10.4 5.0


Narrow
Front 21.0 16.7 14.0 11.2 10.4 8.4

Left 21.0 10.1 14.0 6.7 10.4 5.0

Standard 21.0 20.2 14.0 13.5 10.4 10.1

Right 21.0 10.1 14.0 6.7 10.4 5.0


Normal
Front 21.0 16.7 14.0 11.2 10.4 8.4

Left 21.0 10.1 14.0 6.7 10.4 5.0

Standard 21.0 20.2 14.0 13.5 10.4 10.1

Right 21.0 10.1 14.0 6.7 10.4 5.0


Wide
Front 21.0 16.7 14.0 11.2 10.4 8.4

Left 21.0 10.1 14.0 6.7 10.4 5.0

Standard 18.1 17.2 12.1 11.5 8.9 8.6

Right 18.1 8.6 12.1 5.7 8.9 4.3


Child
Front 18.1 13.8 12.1 9.2 8.9 6.8

Left 18.1 8.6 12.1 5.7 8.9 4.3

Standard 21.0 20.2 14.0 13.5 10.4 10.1

Right 21.0 10.1 14.0 6.7 10.4 5.0

Front 21.0 16.7 14.0 11.2 10.4 8.4


Ortho
Left 21.0 10.1 14.0 6.7 10.4 5.0
gonal
Bitewing 21.0 14.5 14.0 9.7 10.4 7.3

Bitewing
21.0 3.7 14.0 2.5 10.4 1.8
Incisor

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 121


14. Appendices

Image Option

UHD (Optional) HD Normal


Arch Examination
Scan Exposure Scan Exposure Scan Exposure
Type Mode
Time Time Time Time Time Time

(s) (s) (s) (s) (s) (s)

(Optional)

Bitewing Right 21.0 7.3 14.0 4.8 10.4 3.6

Bitewing Left 21.0 7.3 14.0 4.8 10.4 3.6

▪ For Insight PAN mode, only “Normal” is applied to Image Options.

▪ Scan Time: The actual time that the equipment shoots the patient except for the
initial acceleration and late deceleration stages.

▪ Exposure Time: The actual time that the patient is exposed to the X-ray emission.

 SPECIAL Examination

Examination Mode Scan Time (s) Exposure Time (s)

TMJ LAT Open / TMJ LAT Close 14.0 6.2

TMJ PA Open (Optional) / TMJ PA Close (Optional) 13.0 10.1

Sinus LAT (Optional) 6.5 5.9

Sinus PA 10.9 10.3

▪ Scan Time: The actual time that the equipment shoots the patient except for the
initial acceleration and late deceleration stages.

▪ Exposure Time: The actual time that the patient is exposed to the X-ray emission.

122 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

14.1.2 CEPH Mode

ENGLISH
Exposure Condition

Tube Tube
Examination Image Gender / Age X-ray
Voltage Current
Program Option group Intensity
(kVp) (mA)

Hard 92 10.0

Man Normal 90 10.0

Lateral Soft 88 10.0

Full Lateral Hard 90 10.0


Normal /
PA Woman Normal 88 10.0
Fast
SMV Soft 86 10.0

Waters’ view Hard 88 10.0

Child Normal 86 10.0

Soft 84 10.0

Hard 90 6.0

Man Normal 88 6.0

Soft 86 6.0

Hard 88 6.0
Normal /
Carpus Woman Normal 86 6.0
Fast
Soft 84 6.0

Hard 86 6.0

Child Normal 84 6.0

Soft 82 6.0

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 123


14. Appendices

Scan Time / Exposure Time

Image Option

Normal Fast
Examination Program
Scan Time Exposure Time Scan Time Exposure Time

(s) (s) (s) (s)

Lateral 3.9 3.9 1.9 1.9

Full Lateral 5.4 5.4 3.9 3.9

PA 4.9 4.9 2.4 2.4

SMV 4.9 4.9 2.4 2.4

Waters’ view 4.9 4.9 2.4 2.4

Carpus 4.9 4.9 2.4 2.4

▪ Scan Time: The actual time that the equipment shoots the patient except for the
initial acceleration and late deceleration stages.

▪ Exposure Time: The actual time that the patient is exposed to the X-ray emission.

124 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

14.2 X-ray Dose Data

ENGLISH
14.2.1 DAP (Dose Area Product)
The X-ray dose data is extracted from the X-ray Dose Test Report for PaX-i Plus /
PaX-i Insight (Model: PCH-30CS).

X-ray Dose Test Report for the PCH-30CS maintains dosimetry evaluation that the
VATECH dental diagnostic system meets all requirements specified in the IEC
Collateral Standard. To limit unnecessary exposure to the patient, operator or other
staff, PCH-30CS is designed to comply with IEC 60601-1-3 Part 1 General
Requirements for Safety.

Test Hardware

Brand Name (Model) PaX-i Plus / PaX-i Insight (Model: PCH-30CS)

<PaX-i Plus>
PANO: Xmaru1501CF-PLUS
CEPH: Xmaru2602CF
Sensor Type
<PaX-i Insight>
PANO: Xmaru1404CF-PLUS
CEPH: Xmaru2602CF

X-ray Generator DG-07D21T2

Tube D-052SB

DAP (Dose Area Product) is a quantity used in assessing the radiation risk from
diagnostic X-ray examination procedures. It is defined as the absorbed dose multiplied
by the area irradiated, expressed in gray square centimeters (mGy·cm2). Despite the
limitation, DAP is the best way to predict effective dose value and currently the most
convenient method for patient doses monitoring.

▪ PHE (Public Health England) recommends that any national reference dose that
achievable dose (DAP) value of 250 [mGy·cm2] for a clinical protocol for a
standard male patient.

Standard

National Deviations Terminology Permissive Range


PANO: ≤ 93 mGy·cm2 (Adult) / 67 mGy·cm2
DAP
(Child)
PHE (GBR) (Pano and
CEPH: ≤ 40 mGy·cm² (Adult, Lateral) / 25
CEPH)
mGy·cm² (Child, Lateral)
All dose values must be within ± 20 % of the
AERB (IND) Dose
SPECIFIED values

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 125


14. Appendices

DAP (Dose Area Product) Calculation

When you need more information on DAP measurement procedures or


test results for the equipment, please contact VATECH service center
or your local VATECH representative and get assistance from
VATECH-authorized technicians

Measurement Overview

Results
 PaX-i Plus

<PANO>

Gender Tube Tube


PANO Image Arch DAP
/ Age Voltage Current
Option Option Selection (mGy·cm2)
group (kVp) (mA)

Adult 73 9 220
UHD Normal
Child 67 9 127

Adult 73 9 148
Normal HD Normal
Child 67 9 85

Adult 73 7 88
Normal Normal
Child 67 7 49

126 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

<CEPH>

ENGLISH
Tube Tube
CEPH Image Gender / Age DAP
Voltage Current
Examination Option group (mGy·cm2)
(kVp) (mA)

Adult 90 10 23
Normal
Child 86 10 21
Lateral
Adult 90 10 13
Fast
Child 86 10 12

 PaX-i Insight

<PANO>

Gender Tube Tube


PANO Image Arch DAP
/ Age Voltage Current
Option Option Selection (mGy·cm2)
group (kVp) (mA)

Adult 73 9 204
UHD Normal
Child 67 9 127

Adult 73 9 138
Normal HD Normal
Child 67 9 85

Adult 73 7 81
Normal Normal
Child 67 7 50

Insight Adult 70 5 374


Normal Normal
PAN Child 67 5 245

<CEPH>

Tube Tube
CEPH Image Gender / Age DAP
Voltage Current
Examination Option group (mGy·cm2)
(kVp) (mA)

Adult 90 10 23
Normal
Child 86 10 21
Lateral
Adult 90 10 13
Fast
Child 86 10 12

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 127


14. Appendices

14.2.2 Leakage Dose

X-ray Leakage Dose Test is performed to protect patients against excessive and
unnecessary radiation that is not purposed, and this document evaluates leakage dose
amount based on following standard defined by IEC regulation and has been
performed by covering each collimator region in use.

Standard

National Deviation Terminology Permissive Range


International Standard limits leakage at 1M from the source to
Leakage
IEC 60601-1-3 1.0 mGy in 1hr

Measurement Overview

128 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

 PaX-i Plus

ENGLISH
Test Condition

Test Mode Tube Voltage (kVp) Tube Current (mA)

PANO Adult / Normal 99 10

PANO Child / Normal 99 10

CEPH 99 10

Results
Direction PANO Adult / Normal PANO Child / Normal
CEPH [mGy/hr]
[°] [mGy/hr] [mGy/hr]

0 0.044 0.035 0.053

45 0.035 0.053 0.026

90 0.096 0.096 0.114

100 0.079 0.079 0.096

110 0.088 0.088 0.096

120 0.202 0.272 0.254

130 0.105 0.114 0.123

140 0.105 0.105 0.114

150 0.114 0.105 0.114

160 0.114 0.114 0.114

170 0.123 0.132 0.132

180 0.158 0.167 0.167

190 0.184 0.175 0.184

200 0.360 0.272 0.342

210 0.325 0.333 0.316

220 0.263 0.281 0.263

230 0.228 0.237 0.211

240 0.307 0.289 0.281

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 129


14. Appendices

Direction PANO Adult / Normal PANO Child / Normal


CEPH [mGy/hr]
[°] [mGy/hr] [mGy/hr]

250 0.228 0.219 0.211

260 0.228 0.272 0.325

270 0.421 0.439 0.456

315 0.158 0.096 0.114

340 0.430 0.132 0.140

 PaX-i Insight

Test Condition

Test Mode Tube Voltage (kVp) Tube Current (mA)

PANO Adult / Normal 99 10

PANO Child / Normal 99 10

PANO Adult / Insight PAN 99 10

PANO Child / Insight PAN 99 10

CEPH 99 10

Results
PANO Adult PANO Child
PANO Adult PANO Child
Direction / Insight / Insight CEPH
/ Normal / Normal
[°] PAN PAN [mGy/hr]
[mGy/hr] [mGy/hr]
[mGy/hr] [mGy/hr]

0 0.026 0.096 0.035 0.026 0.018

45 0.053 0.018 0.035 0.026 0.018

90 0.088 0.096 0.088 0.079 0.096

100 0.088 0.096 0.088 0.088 0.088

110 0.211 0.246 0.219 0.158 0.140

120 0.123 0.132 0.114 0.123 0.114

130 0.114 0.132 0.114 0.105 0.105

140 0.114 0.114 0.105 0.114 0.105

130 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

PANO Adult PANO Child


PANO Adult PANO Child
Direction / Insight / Insight CEPH

ENGLISH
/ Normal / Normal
[°] PAN PAN [mGy/hr]
[mGy/hr] [mGy/hr]
[mGy/hr] [mGy/hr]

150 0.132 0.123 0.123 0.123 0.123

160 0.132 0.149 0.140 0.149 0.140

170 0.158 0.167 0.158 0.167 0.149

180 0.175 0.263 0.237 0.219 0.219

190 0.351 0.342 0.333 0.351 0.333

200 0.298 0.316 0.289 0.298 0.298

210 0.219 0.237 0.211 0.237 0.219

220 0.184 0.202 0.184 0.184 0.184

230 0.228 0.254 0.184 0.193 0.219

240 0.175 0.193 0.158 0.167 0.167

250 0.219 0.272 0.219 0.237 0.228

260 0.237 0.237 0.211 0.219 0.219

270 0.325 0.316 0.281 0.298 0.289

315 0.123 0.219 0.088 0.079 0.079

340 0.228 0.088 0.123 0.158 0.263

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 131


14. Appendices

14.2.3 Scattered Dose

X-ray Scattered Dose data with respect to varied angle and distance is examined for
recommendations about appropriate radiation level insignificant zones of occupancy
and the effectiveness of protective shielding facility around the patient’s position. This
information states the identity and intended position of the tested phantom and
scattered dosimetry evaluation under the defined scope and test circumstances to
ensure magnitude of risks to the operator and staffs, during both accident situation and
routine work.

Measurement Overview

132 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

 PaX-i Plus

ENGLISH
Test Condition

Test Mode Tube Voltage (kVp) Tube Current (mA) Exposure Time (s)
PANO Adult
99 10 20.2
(UHD) / Normal
PANO Adult
99 10 13.5
(HD) / Normal

Results

 PANO Adult (UHD) / Normal

Direction [°] 1 m [mGy/hr] 1.5 m [mGy/hr] 2 m [mGy/hr]

0 1.158 0.518 0.289


45 0.939 0.421 0.237
90 0.518 0.237 0.132
135 0.561 0.254 0.140
180 0.474 0.211 0.123
225 0.588 0.263 0.149
270 0.868 0.386 0.219
315 1.772 0.789 0.447

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 133


14. Appendices

 PANO Adult (HD) / Normal

Direction [°] 1 m [mGy/hr] 1.5 m [mGy/hr] 2 m [mGy/hr]

0 0.789 0.351 0.193


45 0.825 0.368 0.202
90 0.614 0.272 0.149
135 0.623 0.272 0.158
180 0.509 0.228 0.123
225 0.500 0.219 0.123
270 0.728 0.325 0.184
315 1.421 0.632 0.351

134 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

 PaX-i Insight

ENGLISH
Test Condition

Test mode Tube Voltage (kVp) Tube Current (mA) Exposure Time (s)
PANO Adult
99 10 20.2
(UHD) / Normal
PANO Adult (HD) /
99 10 13.5
Normal
PANO Adult
(Normal) / Insight 99 10 10.1.
PAN

Results

 PANO Adult (UHD) / Normal

Direction [°] 1 m [mGy/hr] 1.5 m [mGy/hr] 2 m [mGy/hr]

0 0.649 0.289 0.158

45 0.596 0.263 0.149

90 0.421 0.184 0.105

135 0.579 0.254 0.140

180 0.456 0.202 0.114

225 0.518 0.228 0.132

270 0.737 0.325 0.184

315 1.333 0.588 0.333

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 135


14. Appendices

 PANO Adult (HD) / Normal

Direction [°] 1 m [mGy/hr] 1.5 m [mGy/hr] 2 m [mGy/hr]

0 0.649 0.289 0.158


45 0.614 0.272 0.149
90 0.412 0.184 0.105
135 0.596 0.263 0.149
180 0.509 0.228 0.123
225 0.544 0.237 0.132
270 0.711 0.316 0.175
315 1.298 0.579 0.325

136 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

 PANO Adult (Normal) / Insight PAN

ENGLISH
Direction [°] 1 m [mGy/hr] 1.5 m [mGy/hr] 2 m [mGy/hr]

0 5.623 2.491 1.395

45 3.553 1.570 0.886

90 2.377 1.053 0.588

135 2.965 1.316 0.737

180 2.254 1.000 0.561

225 2.351 1.044 0.588

270 2.228 0.982 0.553

315 5.868 2.596 1.456

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 137


14. Appendices

14.3 Electromagnetic Compatibility (EMC) Information

Guidance and manufacturer’s declaration - electromagnetic emissions

The PCH-30CS is intended for use in the electromagnetic environment specified as


below. The customer or the user of the PCH-30CS should assure that it is used in
such an environment.
Electromagnetic
Immunity test Compliance environment
- Guidance
The PCH-30CS uses RF
energy only for its internal
function. Therefore, its RF
RF emissions CISPR 11 Group 1 emissions are very low and
are not likely to cause any
interference in nearby
electronic equipment.

RF emissions CISPR 11 Class A The PCH-30CS is suitable for


use in all establishments other
Harmonic emissions IEC than domestic and may be
Class A used in domestic
61000-3-2
establishments and those
directly connected to the
public low-voltage power
supply network that supplies
buildings used for domestic
purposes, provided the
following warning is heeded:
Warning: This
equipment/system is intended
Voltage fluctuations / flicker for use by healthcare
Complies professionals only. This
emissions IEC 61000-3-3
equipment/ system may
cause radio interference or
may disrupt the operation of
nearby equipment. It may be
necessary to take mitigation
measures, such as re-
orienting or relocating the
PCH-30CS or shielding the
location.
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.

138 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

Guidance and manufacturer’s declaration - electromagnetic immunity

ENGLISH
The PCH-30CS is intended for use in the electromagnetic environment specified
below. The customer or the user of the PCH-30CS should assure that it is used in
such an environment.

IEC 60601-1-2 Electromagnetic


Immunity Compliance
environment -
test Test level level
Guidance
Electrostatic ±6 kV Contact ±6 kV Contact Floors should be wood,
discharge ±8 kV air ±8 kV air concrete, or ceramic tile.
(ESD) IEC If floors are covered with
61000-4-2 synthetic material, the
relative humidity should
be at least 30%.
Electrical fast ±2 kV for power ±2 kV for power Main power quality
transient/burst supply lines supply lines should be that of a
IEC 61000-4- ±1 kV for ±1 kV for typical commercial or
4 input/output lines input/output lines hospital environment.

Surge IEC ±1 kV line(s) to ±1 kV line(s) to Main power quality


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

Voltage dips, < 5 % Uт < 5 % Uт Main power quality


short (> 95 % dip in Uт) (> 95 % dip in should be that of a
interruptions for 0.5cycle Uт) for 0.5cycle typical commercial or
and voltage 40 % Uт hospital environment. If
variations on 40 % Uт (60 % dip the user of the PCH-
power supply in Uт ) for 5 cycles, (60 % dip in Uт ) 30CS image intensifier
input lines 6 cycles for 5 cycles requires continued
IEC 61000-4- 70 % Uт (30 % dip 70 % Uт operation during main
11 in Uт) for 25 (30 % dip in Uт) power interruptions, it is
cycles, 30 cycles for 25 cycles recommended that the
<5 % Uт PCH-30CS image
<5 % Uт
intensifier be powered
(< 95 % dip in Uт ) (< 95 % dip in from an uninterruptible
for 5 s Uт) for 5 s power supply or a
battery.
Power 3 A/m 3 A/m Power frequency
frequency magnetic fields should
(50/60 Hz) be at levels
magnetic field characteristic of a typical
IEC 61000-4- location in a typical
8 commercial or hospital
environment.

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

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 139


14. Appendices

Guidance and manufacturer’s declaration - electromagnetic immunity

The PCH-30CS is intended for use in the electromagnetic environment specified


below. The customer or the user of the PCH-30CS should assure that it is used in
such an environment.
IEC 60601-
1-2 Compliance Electromagnetic environment -
Immunity test
level Guidance
Test level
Portable and mobile RF
communications equipment
should be used no closer to any
part of the PCH-30CS, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.

Recommended separation
distance:

Conducted RF 3 Vrms
150 kHz to V1=3Vrms
IEC 61000-4-6
80MHz

3 V/m Where P is the maximum output


Radiated RF
80 MHz to E1=3V/m power rating of the transmitter in
IEC 61000-4-3 2.5GHz watts(W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters(m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a
should be less than the
compliance level in each
frequency range. b
Interference may occur near the
equipment marked with the
following symbol:

NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.


NOTE 2) These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects, and
people.

140 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

a Field strength from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM

ENGLISH
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 in
the location where the PCH-30CS is used exceeds the applicable RF compliance
level above, the PCH-30CS should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the PCH-30CS.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than

[V1] V/m.

Recommended separation distances between portable and mobile RF


communications equipment and the PCH-30CS

This is intended for use in an electromagnetic environment in which radiated RF


disturbances are controlled. The customer or the user of the PCH-30CS can help
Prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the PCH-
30CS as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to the frequency of transmitter [m]
IEC 60601-1-2
Frequency of 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
Transmitter

Equation

V1=3Vrms E1=3V/m E1=3V/m


The rated
maximum output
power of the Separation Separation Separation
transmitter Distance (meters) Distance (meters) Distance (meters)
[W]

0.01 0.116 0.1166 0.2333

0.1 0.368 0.3687 0.7378

1 1.166 1.1660 2.3333

10 3.687 3.6872 7.3785

100 11.660 11.6600 23.333


For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where p is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 141


14. Appendices

NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency
range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects, and
people.
a. Field strength 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 in
the location in which the PCH-30CS is used exceeds the applicable RF compliance
level above, the PCH-30CS should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the PCH-30CS.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than
[V1] V/m.

Immunity and Compliance Level

IEC 60601-1-2 Actual Immunity Compliance


Immunity test
Test level Level Level

Conducted RF 3Vrms
3Vrms 3Vrms
IEC 61000-4-6 150kHz to 80MHz

Radiated RF 3Vrms
3V/m 3V/m
IEC 61000-4-3 80MHz to 2.5GHz

142 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

14.4 Hand-wrist Image Evaluation References

ENGLISH
Radiographic Evaluation of Skeletal Maturation. A clinically oriented method
based on hand-wrist films.

Fishman LS. 1982

The system of Skeletal Maturation Assessment (SMA)

The System uses only four stages of bone maturation, all found at six anatomical sites
located on the thumb, third finger, fifth finger, and radius, as seen Fig.1. Eleven
discrete adolescent skeletal maturational indicators (SMI’s), covering the entire period
of adolescent development, are found on these six sites (Fig.1 orange circles).

[Fig1. The site of skeletal maturity indicators]

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 143


14. Appendices

Skeletal Maturity Indicators (SMI)

A system of skeletal maturation assessment based on four stages of bone maturation


at six anatomical sites in the hand wrist.

[Fig2. Radiographic identification of skeletal maturity indicators]

A. The width of epiphysis as wide as diaphysis

1. Third finger – a Proximal phalanx

2. Third finger – a middle phalanx

3. Fifth finger – a middle phalanx

B. Ossification

1. Adductor sesamoid of thumb

C. Capping of epiphysis

1. Third finger – a distal phalanx

2. Third finger – a middle phalanx

3. Fifth finger – a middle phalanx

144 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

D. Fusion

ENGLISH
1. Third finger – a distal phalanx

2. Third finger – a Proximal phalanx

3. Third finger – a middle phalanx

4. Radius

Eleven Skeletal maturity indicators (SMIs)

The System uses only four stages of bone maturation, all found at six anatomical sites
located on the thumb, third finger, fifth finger, and radius, as seen Fig.1. Eleven
discrete adolescent skeletal maturational indicators (SMI’s), covering the entire period
of adolescent development, are found on these six sites (Fig.1 orange circles).

[Fig3. Eleven Skeletal maturity indicators (SMIs)]

A systematic observational scheme such as that shown in the figure above can further
facilitate SMI evaluation. With this approach, key stages are checked first, rather than
looking for maturity indicators in numerical order. A useful step is to determine if the
adductor sesamoid of the thumb can be seen (orange circle). If not, then the applicable
SMI will be one of those associated with early epiphyseal widening rather than capping.
If the sesamoid is visible, then either the sesamoid or an SMI based on capping or
fusion will be applicable.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 145


14. Appendices

146 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

14.5 Acquiring Images for Pediatric Dental Patients

ENGLISH
14.5.1 Age Group: Classification Table

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

Age Group FDA’s standard VATECH’s Standard

Infant 1 month to 2 years N/A

Child 2 ~ 12 years of age Child

Adolescent 12 ~16 years of age

Other 16 ~ 21 years of age Adult

Adult > 21 years of age

14.5.2 Positioning the Pediatric Dental Patients

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

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

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 close lips 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 sucks in the cheeks, pushing the tongue into the correct flat position against the
palate and maintain this position throughout the exposure.

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 147


14. Appendices

<How to product error-free radiographic images for the pediatric patient>

(http://www.dimensionsofdentalhygiene.com/print.aspx?id=3612)

- By Evelyn M. Thomson, BSDH, MS

Panoramic radiographs are often recommended for assessing growth and


development of the pediatric patient and for evaluation of developing third molars
during adolescence.1-3 While the panoramic technique seems relatively straightforward,
producing a diagnostic quality image of the pediatric patient requires a mastery of
technical skill.4 Modern panoramic x-ray equipment is designed for ease of use, yet
studies continue to demonstrate a high incidence of errors.5-7 Positioning errors may
occur at an even higher rate in pediatric panoramic radiographs.7 The goal of the
dental hygienist is to maximize the use of panoramic imagery in the assessment of the
pediatric patient while minimizing the occurrence of retakes that result from the
radiographic error.

Producing A Quality Panoramic Image

A quality panoramic radiograph should image all the teeth, erupted and unerupted, in
both the maxillary and mandibular arches from condyle to condyle in the horizontal
dimension, and from the superior third of the orbit in the superior region to the inferior
border of the mandible in the inferior region.8,9 The arches should appear straight or
slightly U-shaped with the occlusal plane parallel to the horizontal edges of the film
(Figure 1). The anterior teeth must not be magnified or diminished in size and
overlapping of adjacent posterior teeth should be kept to a minimum.

The most important component in producing a diagnostically acceptable panoramic


image is the patient positioning. All panoramic x-ray machines have guidelines to
assist with positioning the dental arches within the three dimensions of the focal trough,

148 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

an area where the anatomical structures will be imaged in relative clarity. Most

ENGLISH
panoramic x-ray machines have a bite block to indicate the correct anterior-posterior
position or how far forward or back the patient should be positioned, side positioner
guides for determining the correct lateral alignment, and a chin rest to correctly locate
the superior-inferior dimension or how far up or down the chin should be positioned.4,10
Panoramic x-ray machines are available with a mirror and laser light beam guide that
shines on the patient's face to illustrate various anatomical planes (Figure 2).
Incorrectly positioning the patient in any of these three dimensions will produce unique
and distinct radiographic image errors (Table 1).

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 149


14. Appendices

Anterior-Posterior Positioning Error

When the arches are positioned incorrectly in the anterior-posterior direction, distortion
or ghosting of the anterior anatomy occurs. Unerupted teeth in the anterior region may
not be imaged on the radiograph if positioned outside of the focal trough. It is
important to note that an error of only 3 mm to 4 mm in either direction will result in a
significantly compromised image.11 When the arches are positioned too far anterior,
the anterior teeth will appear narrow and diminished in size. The vertebrae of the
spinal column may be superimposed over the condyles at the edges of the film and,
depending on the size of the child, may be superimposed over the rami of the
mandible blocking a clear view of the posterior teeth (Figure 3). When the arches are
positioned too far posteriorly, the anterior teeth will appear broad or widened. If the
position is excessively posterior, anterior teeth may be completely blurred from the
image and the condyles may be cut off from the edges of the film.

To avoid these imaging errors, the anterior teeth must occlude edge-to-edge onto the
designated area of the bite block. Achieving this position is easily compromised during
exfoliation of primary teeth, making precise occlusion difficult when one tooth or
multiple teeth are missing or partially erupted. A cotton roll may be attached to the bite
block to fill in the space created by the missing tooth or teeth. Additionally, an
adjustment may be necessary when using a laser light beam guide. The
manufacturer's instructions for directing the laser light beam at a predetermined tooth
or interproximal space usually apply to adult patients. These instructions may need to
be modified for the pediatric patient with primary or mixed dentition.

150 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

Lateral Left-Right Positioning Error

ENGLISH
When the arches are positioned incorrectly in the lateral left-right dimension, the
posterior teeth on one side will appear broad or widened, while the teeth on the other
side will appear narrowed or diminished in width and severely overlapped (Figure 4).
This image distortion is like that which occurs with an incorrect anterior-posterior
position. When the arches are rotated or tilted, the posterior teeth on one side move
out of the focal trough to a position further away (back) from the image receptor, while
the opposite side simultaneously moves closer (forward) to the image receptor.
Depending on the severity of rotation or tilting, the inferior border of the mandible will
appear distorted and the condyles and rami will appear asymmetrical.

To avoid imaging errors that result from incorrect lateral positioning, the midsagittal
plane must be positioned perpendicular to the floor. Most panoramic x-ray machines
have a head positioner and/or laser light beam guide, along with a mirror, to assist in
determining the correct lateral head position. The pediatric patient may need additional
instructions to maintain the correct position throughout the exposure.

Movement of the tube head during exposure may pique the pediatric patient's curiosity,
causing the head to rotate as the eyes follow the movement of the tube head. A
vertical line decal affixed to the mirror can serve as a visual aid and a focus point. An
eye-catching sticker, such as those purchased from a craft store, can be adhered to
the mirror in a position that aligns with the midsagittal plane. The patient can be
directed to position the head so that the sticker appears at the tip of the nose and to
maintain focus on this reflection throughout the exposure. Pediatric patients may find
looking at themselves in the mirror entertaining and a fun way to participate in the
process.9

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 151


14. Appendices

Superior-Inferior (Up-Down) Positioning Error

Positioning the dental arches within the superior-inferior (up-down) dimension of the
focal trough can be difficult to achieve, especially with children whose smaller size
reduces the distance between the shoulders and the inferior border of the chin. When
the arches are positioned incorrectly in the superior-inferior direction, the image
exhibits multiple distortions, including increased overlapping in the premolar regions.
When the arches are positioned too far up or down, the teeth will simultaneously move
into a position that is too far back or too far forward, respectively, out of the focal
trough.11

Positioning the arches too far superiorly produces a characteristic "frown" or flat,
downward- turned appearance to the occlusal plane (Figure 5). The condyles flare out
and off the edges of the image and the palate appears as a widened, thick, dense
radiopacity. This positioning error results in a widened appearance of the palate and
obliterates the apical regions of the maxillary teeth, compromising the images of the
unerupted developing dentition. As the maxillary arch tips upward, the anterior teeth tilt
backward producing the same widened appearance that results from an incorrect
anterior-posterior position. Positioning the arches too far inferior produces a
characteristic "smile" appearance or upward curve of the occlusal plane, with the
condyles tilting inward toward the center of the image (Figure 6). Depending on the
severity of the downward position, the vertebrae may also curve inward and appear
superimposed over the condyles, and the hyoid bone may be superimposed over the
mandible blocking a clear view of the erupted and unerupted mandibular teeth.

152 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

ENGLISH
Correct positioning of the arches in the superior-inferior dimension requires that the
patient stands with erect posture while tucking the chin in and down slightly, a direction
that both adults and pediatric patients often find difficult to follow without specific
guidance. The result is often a slumped position with the patient hunching the neck
and shoulders over to place the chin on the chin rest. The vertebrae collapse causing
attenuation of the x-ray beam that produces a triangular radiopacity superimposed
over the mandible, and if severe, over the maxillary anterior regions as well.

Depending on the manufacturer, panoramic x-ray machines direct the operator to


position the Frankfort or the canthomeatal plane parallel to the floor, or the ala-tragus
line 5° down toward the floor. This is achieved by raising or lowering the chin rest so
that the appropriate landmark lines up with indicators on the machine (Figure 2). The
patient should be directed to stand in front of the panoramic x-ray machine allowing
the operator to place the chin rest into a position that is slightly higher than the
patient's chin. The patient is then requested to move into the overhead assembly of
the machine and remain standing tall. If further adjustment is needed, it is usually to a
lowered chin position. Once the patient's chin is resting on the chin rest, it is easier to
move to a lower position than to a higher one. To assist with placing the chin on the
chin rest while maintaining an erect posture, the pediatric patient can be directed to
stand like a soldier. Most children are familiar with the straight back, chest forward
tucked chin position demonstrated by military persons, and can readily mimic this
stance.

Further Recommendations

Prior to beginning the exposure, the patient should be directed to close the lips around
the bite block and to place the tongue against the palate. Leaving the lips open will
create a soft tissue shadow across the teeth that that can be mistaken for caries.7
Leaving the tongue at rest during the exposure allows the radiation to easily penetrate
the empty space of the oral cavity between the dorsal surface of the tongue and the

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 153


14. Appendices

palate, producing a radiolucent shadow that diminishes the diagnostic quality of the
radiograph (Figure 3).

"Filling in" this space with the soft tissue of the tongue can increase the quality of the
image by diminishing this radiolucent shadow. When directed to place the tongue on
the roof of the mouth, the pediatric patient is likely to press only the tip of the tongue
against the palate. While an adult patient can usually understand what is required
when directed to swallow and note the position of the tongue, a child may be directed
to suck in the cheeks, which results in pushing the tongue into a position flat against
the palate.7

Conclusion

In addition to these guidelines for producing error-free radiographic images for the
pediatric patient, panoramic machines should be evaluated periodically for accuracy.
Changes may occur over time to the focal trough that interferes with the diagnostic
quality of the machine.6 If a decrease in image quality is noted despite following
accurate patient positioning steps, the panoramic x-ray machine should be inspected,
and the focal trough recalibrated. The dental hygienist who is skilled in understanding
panoramic equipment operation and pediatric patient management is more likely to
produce radiographic images that result in higher diagnostic yields.

References

1. Public Health Service, Food and Drug Administration, American Dental Association Council on
Dental Benefits Program, Council on Dental Practice, Council on Scientific Affairs. The Selection
of Patients for Dental Radiographic Examinations. Washington, DC: United States Department of
Health and Human Services; 1987 (revised 2005):1-23.
2. Pinkham PS, Casamassimo, Fields HW, McTigue DJ, Nowak AJ. Pediatric Dentistry Infancy
through Adolescence. 4th ed. St. Louis: Elsevier Saunders; 2005:677.
3. Thomson EM. Panoramic radiographs and the pediatric patient. Dimensions of Dental Hygiene.
2008;6(2):26-29.
4. Rushton VE, Rout J. Panoramic Radiology. London: Quintessence Publishing Co Ltd; 2006:17,
84-85.
5. Kullman L, Joseph B. Quality of digital panoramic radiography in a newly established dental
school. Swedish Dent Journal. 2006; 30: 165-170.
6. Akarslan ZZ, Erten H, Güngör K, et al. Common errors on panoramic radiographs taken in a
dental school. J Contemp Dent Pract. 2003;4:24-34.
7. Rushton VE, Horner K, Worthington HV. The quality of panoramic radiographs in a sample of
general dental practices. Br Dent J. 1999; 26: 630-633.

154 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

8. White SC, Heslop EW, Hollender LG, Mosier KM, Ruprecht A, Shrout MK. Parameters of
radiologic care: an official report of the American Academy of Oral and Maxillofacial Radiology.

ENGLISH
Oral Surg Oral Med Oral Pathol. 2001;91:498-511.
9. McDonald RE, Avery DR, Dean JA. Dentistry for the Child and Adolescent. 8th ed. St. Louis:
Elsevier Mosby; 2000:71-72.
10. Johnson ON, Thomson EM. Essentials of Dental Radiography for Dental Assistants and
Hygienists. 8th ed. Upper Saddle River, NJ: Prentice-Hall 2007:388-397.
11. Sherman N, Horrell BM, Singer, S. High-quality panoramic radiographs. Tips and tricks.
Dentistry Today. 2003;22(1):70-73.

14.5.3 Setting Exposure Values to the Age Group

For more information about this topic, refer to the Appendices 15.1 Recommended X-
Ray Exposure Table.

14.5.4 The References Pertinent to the Potential Risks for the Pediatric
Patients

1) Literature

▪ I. ESPELID, I. MEJÀ RE, K. WEERHEIJM:

EAPD guidelines for use of radiographs in children, P40-48. European Journal of


Pediatric Dentistry 1/2003 Guidelines in dental radiology is 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 the 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. A 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.

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


PH.D.:

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 155


14. Appendices

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

2) Website

For additional information on pediatric X-ray imaging, please refer to the websites
below.

▪ http://www.fda.gov/radiation-
emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm29
8899.htm

▪ http://www.imagegently.org/

156 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


14. Appendices

14.6 Abbreviations

ENGLISH
AC Alternating Current

AF Auto-Focusing

AMPT Adaptive layer Mode Panoramic Tomography

CAN Controlled Area Network

CMOS Complementary Metal-Oxide -Semiconductor

DAP Dose Area Product

DC Direct Current

DICOM Digital Imaging and Communications in Medicine

EMC Electromagnetic Compatibility

ESD Electrostatic Discharge

EUT Equipment Under Test

FDD Focal spot to Detector Distance

FOD Focal spot to Object Distance

FPD Flat Panel Detector

IEC International Electro technical Commission

ISO International Standards Organization

LED Light-Emitting Diode

MPSO Multiple Portable Socket-Outlet

ODD Object to Detector Distance

PA Posterior / Anterior

RF Radio Frequency

ROI Region of Interest

SID Source to Image Receptor Distance

SIP Signal Input Part

SOP Signal Output Part

SMV Submento-Vertical

TMJ Temporomandibular Joint

UHD Ultra High Definition

PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual 157


14. Appendices

158 PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual


Copyright by © 2018 VATECH Co., Ltd.

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.

Tel: (+82) 1588-9510

Email: [email protected]

Website: www.vatech.co.kr

Headquarters: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea

Factory: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, 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 IIb 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

You might also like