2018 Vatech
2018 Vatech
2018 Vatech
Notice
Thank you for purchasing the PaX-i Plus / PaX-i Insight (Model: PCH-30CS) extra-
oral imaging system.
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:
Phone: +82-1588-9510
E-mail: [email protected]
Manual Name: PaX-i Plus / PaX-i Insight (Model: PCH-30CS) User Manual
Version: 1.31
Table of Contents
Notice................................................................................................................. v
1. Introduction ........................................................................................ 1
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.
- 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
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 in accordance with all the cautions and
conditions required for installation.
▪ The genuine VATECH approved equipment and components have been used
always.
▪ 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.
▪ 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.
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.
ENGLISH
Symbols Description Location
Power board /
Dangerous voltage Inverter board /
Monoblock
CSA mark
Label
No.266436
MCU board /
Warns ESD hazard.
Board package
ENGLISH
The label is attached to the right side of the equipment and it consists of 5 parts as
below.
No. Item
CAUTION Label
2
- X-ray / Attention: X-ray on when equipment in operation.
X-RAY GENERATOR Label
3
: 1.0 kW Generator
Manufacturer Label
5
- The date of manufacture / Serial Number / Weight of the equipment
ENGLISH
Be sure to strictly observe all warnings and safety instructions included
in this manual.
Operator qualifications
This equipment may only be operated by personnel fully trained in its operation.
▪ 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 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.
▪ 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 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).
Ventilation
▪ Always leave enough space around the PC to allow for proper ventilation.
Hygiene
▪ 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.
▪ 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.
Condensation
Cooling
▪ Allow the proper amount of cool down time (for the X-ray tube to cool down)
before the acquisition of next image.
▪ 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).
▪ 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.
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
▪ 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).
▪ 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 in any way which may affect the safety of the operator,
patients or other persons is prohibited by law.
▪ This product may only be operated with original VATECH accessories or third-
party accessories expressly approved by VATECH.
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.
▪ Never overload the equipment’s circuit by sharing it with too many appliances.
▪ Use the same power circuit for the PC and the equipment.
▪ Do not connect this equipment to devices which are not designated as a part of
the system.
Electromagnetic compatibility
▪ 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.
Static Discharge
▪ Connector pins or sockets bearing ESD warning labels must not be touched or
interconnected without observing ESD protective measures.
▪ Electrostatic discharge of your own body with the frame of the equipment, the
protective ground wire or large metallic objects
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.
▪ 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 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.
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.
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.
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.
▪ 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.
▪ 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.
Installation
▪ If the equipment is not stable, property damage and/or personal injury may occur.
Security Capabilities
▪ The latest updates for anti-virus software and a firewall are recommended.
ENGLISH
4.1 System Components
▪ PC system
4.2 Features
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
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.
ENGLISH
Input / Output for PC
No. Item
USB Camera input (USB 3.0 Cable)
3 Video output
4 Fiber optic cable (Data in / out)
ENGLISH
No. Item Description
X-ray Detector
1 for CEPH Xmaru2602CF for CEPH imaging sensor
(Optional)
ENGLISH
No. Item Description
Laser Beam
2 Turns the Laser Beam on / off.
ON/OFF button
▪ X-ray emission even after the Exposure Switch has been released
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.
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.
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
Protractor (1 set)
: For positioning the patient’s PC (Polycarbonate)
body in CEPH mode.
ENGLISH
Three programs are included in this equipment to acquire, process, and view the
image:
PaX-i Plus
Item Specifications
PaX-i Insight
Item Specifications
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.
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.
Use the Console Software to configure the imaging environment according to the
mode.
The Main Screen of the Console Software consists as follows. Each imaging mode will
be described later.
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
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.
ENGLISH
Applies the selected settings and moves to the next step.
(Exposure parameter setting and patient positioning >
Ready for exposure)
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.
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.
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.
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.
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.
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.
2. Double-click the patient information to see more details about the patient as shown
below.
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.
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.
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.
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.
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
Examination
Arch Selection ROI Example
Type
Standard
Right
Narrow
Normal
PANO
Wide
Examination
Child
Orthogonal Front
Left
Examination
Arch Selection ROI Example
Type
Bitewing*
Bitewing Incisor*
(Optional)
Orthogonal
Bitewing Right*
Bitewing Left*
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.
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
Normal Standard
PANO
Examination
Wide Standard
Examination Arch
ROI Description & Sample Image
Type Selection
Standard
Bitewing**
(Bitewing
Incisor mode is
Optional)
Examination Arch
ROI Description & Sample Image
Type Selection
** Bitewing imaging mode is activated only when Orthogonal is selected in Arch Selection.
You can set the imaging parameters on the Console Software running
on the PC. They are synchronized and display the same environmental
settings.
“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.
PaX-i Plus
PaX-i Insight
Mode Description
Normal (Default) - Provides a normal panoramic image.
Mode Description
UHD (Optional) Ultra High Definition image
HD (Default) High Definition image
Normal Normal quality image
6. The Gender / Age group of the patient is selected automatically based on the patient
information. If necessary, you can select the option manually.
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.
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.
▪ 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.
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.
To acquire the best image possible, ask the patient not to:
- Breathe or swallow saliva during image acquisition
- Move during image acquisition
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.
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.
Be careful not to shine the laser beam directly into the person's eyes.
Doing so may result in vision loss.
▪ To turn the Laser beams on/off manually, click the icon on the
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.
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.
The TMJ Close image can be acquired after the TMJ Open image is acquired.
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.
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.
Be careful not to shine the laser beam directly into the person's eyes.
Doing so may result in vision loss.
▪ To turn the Laser beams on/off manually, click the icon on the
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.
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.
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.
.
Laser Beam Aligning
This is the same as the one for TMJ Open mode.
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.
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.
Be careful not to shine the laser beam directly into the person's eyes.
Doing so may result in vision loss.
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.
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.
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.
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
Examination
Description Position
Area
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>
<Waters’ view>
<Carpus>
You can set the imaging parameters on the Console Software running
on the PC. They are synchronized and display the same environmental
settings.
“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.
Mode Description
Normal Normal quality image
Fast (Default) Low dose image
4. The Gender / Age group of the patient is selected automatically based on the patient
information. If necessary, you can select the option manually.
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.
Ensure that the Nasal Positioner is left unfolded, before adjusting the
Ear Rods in the proper direction.
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.
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.
Use the Porion Position Reference Indicator that appears in the acquired
image to easily confirm the location of Porion.
After adjusting the height of the column, align the Ear Rods and Nasal
Positioner to the patient.
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.
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.
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.
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.
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.
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.
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.
For Carpus Mode, install the Carpus Plate first before positioning the patient.
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.
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.
Scan Area
Available Programs
It is classified as below.
Mode Description
Captures both 3D PHOTO images and CEPH Lateral
3D PHOTO + Lateral
images.
“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.
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.
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.
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.
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.
▪ 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.
“CEPH” and “3D PHOTO” buttons exist only when each imaging
program is included in the equipment.
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.
▪ 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.
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.
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 Laser Beam has shut off and patient positioning cannot be performed
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.
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.
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.
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 ●
Item Description
Item Description
Model DG-07D21T2
Rated output power 1.0 kW
Inverter model
INV-21
name
Type Inverter
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
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
ENGLISH
PaX-i Plus
Description
Item
PANO CEPH
Model Xmaru1501CF-PLUS Xmaru2602CF
Analogue-Digital
14 bits
Conversion
174 (W) x 79 (L) x 30.2 (H) 279 (W) x 110 (L) x 20 (H)
Sensor size
mm mm
Converter Csl:Ti
PaX-i Insight
Description
Item
PANO CEPH
Model Xmaru1404CF-PLUS Xmaru2602CF
Analogue-Digital
14 bits
Conversion
Converter Csl:Ti
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.
Item Description
Temperature 10 ~ 35 ℃
Temperature -10 ~ 60 ℃
During Transport
Relative humidity 10 ~ 75 %
and Storage
Atmospheric pressure 860 ~ 1060 hPa
ENGLISH
14. Appendices
14.1 Recommended X-ray Exposure Tables
14.1.1 PANO Mode
Exposure Condition
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
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
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
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
Tube Tube
Gender / X-ray
Mode Image Option Voltage Current
Age group Intensity
(kVp) (mA)
Soft 66 7
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
ENGLISH
PANO Examination
Image Option
Bitewing
21.0 3.7 14.0 2.5 10.4 1.8
Incisor
Image Option
(Optional)
▪ 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
▪ 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.
ENGLISH
Exposure Condition
Tube Tube
Examination Image Gender / Age X-ray
Voltage Current
Program Option group Intensity
(kVp) (mA)
Hard 92 10.0
Soft 84 10.0
Hard 90 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
Soft 82 6.0
Image Option
Normal Fast
Examination Program
Scan Time Exposure Time Scan Time Exposure Time
▪ 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.
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
<PaX-i Plus>
PANO: Xmaru1501CF-PLUS
CEPH: Xmaru2602CF
Sensor Type
<PaX-i Insight>
PANO: Xmaru1404CF-PLUS
CEPH: Xmaru2602CF
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
Measurement Overview
Results
PaX-i Plus
<PANO>
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
<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>
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
<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
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
Measurement Overview
PaX-i Plus
ENGLISH
Test Condition
CEPH 99 10
Results
Direction PANO Adult / Normal PANO Child / Normal
CEPH [mGy/hr]
[°] [mGy/hr] [mGy/hr]
PaX-i Insight
Test Condition
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]
ENGLISH
/ Normal / Normal
[°] PAN PAN [mGy/hr]
[mGy/hr] [mGy/hr]
[mGy/hr] [mGy/hr]
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
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
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
ENGLISH
Direction [°] 1 m [mGy/hr] 1.5 m [mGy/hr] 2 m [mGy/hr]
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.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
Recommended separation
distance:
Conducted RF 3 Vrms
150 kHz to V1=3Vrms
IEC 61000-4-6
80MHz
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.
Equation
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.
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
ENGLISH
Radiographic Evaluation of Skeletal Maturation. A clinically oriented method
based on hand-wrist films.
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).
B. Ossification
C. Capping of epiphysis
D. Fusion
ENGLISH
1. Third finger – a distal phalanx
4. Radius
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).
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.
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.
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.
(http://www.dimensionsofdentalhygiene.com/print.aspx?id=3612)
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.
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).
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.
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
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.
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.
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
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.
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.
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
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/
14.6 Abbreviations
ENGLISH
AC Alternating Current
AF Auto-Focusing
DC Direct Current
PA Posterior / Anterior
RF Radio Frequency
SMV Submento-Vertical
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