Vatech Premium PAX-i3D User manual

PCT-90LH User Manual 3

PCT-90LH User Manual v
Notice
Thank you for purchasing the PaX-i3D Green Premium™ (Model: PCT-90LH) extra-
oral imaging system.
PaX-i3D Green Premium™ is an advanced digital X-ray imaging system that
incorporates PANO, i-CEPH (Optional), 3D CT (Dental / ENT) and 3D PHOTO
(Optional) imaging capabilities into a single system for Dental and ENT(Ear, Nose and
Throat) diagnostics.
PaX-i3D Green Premium™ may be used by dentists, X-ray technicians and other
professionals who are licensed to perform X-rays by the law of the region in which it is
being used.
This manual describes how to operate the PaX-i3D Green Premium™ system. It is
recommended that you thoroughly familiarize yourself with this manual in order to
make the most effective use of this equipment.
Observe all cautions, safety messages and warnings which appear in this manual.
Due to 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: [phone]
E-mail: [e-mail]
This document is originally written in English.
The PaX-i3D Green Premium™ is referred to as “equipment” in this manual.
Manual Name: PaX-i3D Green Premium™ (Model: PCT-90LH) User Manual
Version: 1.2
Publication Date: 2016-12

vi PaX-i3D Green Premium™ User Manual
Table of Contents
Notice ................................................................................................................ v
Table of Contents ............................................................................................. vi
1. Introduction ........................................................................................ 1
1.1 Overview ......................................................................................... 1
1.2 Indications for use ........................................................................... 1
1.3 Intended purposes ........................................................................... 1
1.4 Intended User Profile........................................................................ 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 Imaging System Configuration ........................................................ 21
4.5 Equipment Overview ...................................................................... 23
5. Imaging Software Overview ............................................................. 39
5.1 PC Specifications (Recommended)................................................... 40
5.2 EzDent-i ........................................................................................ 41
5.3 Console Software ........................................................................... 42
6. Getting Started.................................................................................. 47
6.1 Turning on the Equipment .............................................................. 47
6.2 Running the Image Viewer (EzDent-i).............................................. 48
6.3 Initiating the Console Software ....................................................... 51
7. Acquiring PANO Images .................................................................... 53
7.1 PANO Imaging Program Overview ................................................... 53
7.2 Configuring Exposure Parameters.................................................... 58

PCT-90LH User Manual vii
7.3 Getting Prepared for Patient Positioning........................................... 62
7.4 Patient Positioning.......................................................................... 64
7.5 X-ray Exposure............................................................................... 78
7.6 Checking the captured image.......................................................... 80
8. Acquiring i-CEPH Images (Optional) .................................................81
8.1 i-CEPH Imaging Program Overview.................................................. 81
8.2 Configuring Exposure Parameters.................................................... 83
8.3 Getting Prepared for Patient Positioning........................................... 86
8.4 Patient Positioning.......................................................................... 88
8.5 X-ray Exposure............................................................................... 93
8.6 Checking the captured image.......................................................... 95
9. Acquiring Dental CT Images ..............................................................97
9.1 Dental CT Imaging Program Overview ............................................. 97
9.2 Configuring Exposure Parameters.................................................... 99
9.3 Getting Prepared for Patient Positioning......................................... 105
9.4 Patient Positioning........................................................................ 107
9.5 X-ray Exposure............................................................................. 113
9.6 Checking the captured image........................................................ 115
10. Acquiring ENT CT Images ................................................................117
10.1 ENT CT Imaging Program Overview............................................... 117
10.2 Configuring Exposure Parameters.................................................. 119
10.3 Getting Prepared for Patient Positioning......................................... 124
10.4 Patient Positioning........................................................................ 126
10.5 X-ray Exposure............................................................................. 132
10.6 Checking the captured image........................................................ 134
11. Acquiring 3D PHOTOs (Optional).....................................................135
11.1 3D PHOTO Imaging Program Overview.......................................... 135
11.2 Taking 3D PHOTOs ....................................................................... 136
11.3 Checking 3D PHOTOs ................................................................... 139
12. Troubleshooting ..............................................................................141
13. Cleaning and Maintenance ..............................................................143
13.1 Cleaning ...................................................................................... 143
13.2 Maintenance ................................................................................ 144
14. Disposing of the Equipment.............................................................147
15. Technical Specifications ..................................................................149
15.1 Mechanical Specifications.............................................................. 149
15.2 Technical Specifications ................................................................ 151
15.3 Electrical Specifications................................................................. 158

viii PaX-i3D Green Premium™ User Manual
15.4 Environmental Specifications..........................................................159
16. Appendices ...................................................................................... 161
16.1 Recommended X-ray Exposure Table ..............................................161
16.2 X-ray Dose Data............................................................................166
16.3 Electromagnetic Compatibility (EMC) Information ............................175
16.4 Hand-wrist Image Evaluation References ........................................180
16.5 Acquiring Images for Pediatric Dental Patients ................................184
16.6 Abbreviations................................................................................195

1. Introduction
PCT-90LH User Manual 1
ENGLISH
1. Introduction
1.1 Overview
PaX-i3D Green Premium™ (Model: PCT-90LH) is an advanced 4 in 1 digital X-ray
imaging system that incorporates PANO, i-CEPH (Optional), 3D CT (Dental / ENT) and
3D PHOTO (Optional) imaging capabilities into a single system for Dental and ENT
(Ear, Nose and Throat) diagnostics.
PaX-i3D Green Premium™a digital radiographic imaging system, acquires and
processes multi FOV diagnostic images for dentists and ENT specialists. Specifically
designed for dental and ENT radiography, PaX-i3D Green Premium™ is a complete
digital X-ray system equipped with imaging viewers, X-ray generator and a dedicated
SSXI detector.
The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT
detector is used to capture 3D radiographic images of head, neck and craniofacial
anatomy for ENT, oral surgery, implant and orthodontic treatment. PaX-i3D Green
Premium™ can also acquire 2D diagnostic image data in panoramic and
cephalometric mode.
1.2 Indications for use
PaX-i3D Green Premium™ (Model: PCT-90LH) is intended to produce panoramic,
cephalometric or 3D digital x-ray images.
It provides diagnostic details of the dento-maxillofacial, ENT, sinus and TMJ for adult
and pediatric patients.
The system also utilizes carpal images for orthodontic treatment. The device is to be
operated by healthcare professionals.
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
- Assessment of fractures on facial bones, mandible, condylar neck, orbital floor and
fractures of teeth where plain film imaging is equivocal
- Visualization of 3D anatomy of the alveolar clefts
- Diagnosis of un-erupted teeth, impacted teeth and odontomas
- Diagnosis of root resorption of teeth
- Assessment of cleft palate

1. Introduction
2 PaX-i3D Green Premium™ User Manual
- Planning any craniofacial surgery where 3D models of the jaw/facial skeleton/skull
are required
- Diagnosis of most malformations and dysplasia, traumatic lesions and thin osseous
labyrinthine wall erosion or dehiscence through CBCT inner ear imaging
- Visualization of eustachian tube obstruction
- Reconstruction of position, malformations and fractures of nasal and facial bones and
paranasal sinuses as 3D pictures for operational planning and patient education
- Air-mucosa-bone contrast for detailed study of air cavity anatomy and ventilation
- Instant diagnosis of CRS (chronic rhinosinusitis)
- Examinations of the airways for measuring the volume and dimensions of air
passages
1.4 Intended User Profile
Considerations Requirement Description
Education
Licensed dentists or dental hygienists, radiologists
and graduates of relevant bachelor’s degree
(national qualifications)
Knowledge
Understanding of the treatment and diagnosis of
dental disease
Understanding the terms and guidance of
hardware and software of a diagnostic medical
radiation device and recognizing device
connection, installation, operating conditions
Language
understanding
Understanding how to use manuals (English /
Korean) Or
Understanding other language provided
Experience
Understanding of the objectives and effects of the
diagnosis and treatment of dental disease using
diagnostic medical radiation devices
Understanding of the normal operation of
diagnostic medical radiation equipment
Understanding of the contents of the User Manual
The dental X-ray CT should be used by qualified personnel (dentists,
dental hygienists or radiologists) only.

2. General Information
PCT-90LH User Manual 3
ENGLISH
2. General Information
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 VAT ECH-authorized technician.
The equipment has been installed in accordance with all of the cautions and
conditions required for installation.
The genuine VATEC H approved equipment and components have been used at
all times.
All maintenance and repairs have been performed by a VATE CH -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 in
order to ensure patient and operator safety. These tests must be performed in
accordance with local X-ray safety regulations.
The owner of this equipment shall perform regular inspection and maintenance of
the mechanical and electrical components in this equipment to ensure safe and
consistent operation (IEC 60601-1).
The owner of this equipment shall ensure inspection and cleaning work are performed
in accordance with the maintenance schedule outlined in Chapter 13. Cleaning and
Maintenance.

2. General Information
4 PaX-i3D Green Premium™ User Manual
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.
WARNING
Indicates information that should be followed with
the utmost care. Failure to comply with a warning
may result in severe damage to the equipment or
physical injury to the operator and/or patient.
CAUTION
Indicates a situation that demands prompt and
careful action, a specific remedy, or emergency
attention.
IMPORTANT
Indicates a situation or action that could
potentially cause problems to the equipment
and/or its operation.
NOTE Emphasizes important information or provides
useful tips and hints.
RADIATION Indicates a possible danger from exposure to
radiation.
SINGLE USE Indicates a component which must be replaced
for each new patient.
ESD
susceptibility
Indicates that an item is susceptible to damage
from electrostatic discharges.

2. General Information
PCT-90LH User Manual 5
ENGLISH
2.4 Marks and Symbols
Symbols Description Location
Dangerous voltage Power
board
Warns ESD hazard.
MCU
board /
Board
package
Protective earth (Ground) Column
Off (power: disconnected to the Main
Power Switch)
Main
Power
Switch
On (power: connected to the Main
Power Switch)
Main
Power
Switch
Alternate current Label
Type B Applied Equipment
(IEC 60601-1: Degree of protection
against leakage current and/or electric
shock: Class 1 equipment)
Label
Radiation hazard Label
Indicates the authorized representative
in the European Community. Label
The CE symbol indicates that this
product complies with the European
Directive for Medical Devices
93/42/EEC as amended by 2007/47/EC
as a class IIb device.
Label
UL mark : UL 60601-1 / CAN / CSA
C22.2 No.601.1 Label
Addresses where the equipment was
manufactured. Label

2. General Information
6 PaX-i3D Green Premium™ User Manual
Symbols Description Location
Indicates that electrical and electronic
equipment must not be disposed of as
unsorted municipal waste and must be
collected separately.
Label
Indicates that this equipment is
classified as a CLASS 1 LASER
PRODUCT in accordance with IEC
60825-1 ED.2 regulations.
Label
Indicates the date when the equipment
was manufactured.. Label
Indicates that the user needs to refer to
the Instruction Manual.Label

2. General Information
PCT-90LH User Manual 7
ENGLISH
2.4.1 Label Locations
No. Item
1PaX-i3D Green Premium™ (Model: PCT-90LH) Main Label
2
X-ray GENERATOR Label
- This part has two types according to the X-ray Tube model implemented.
* Type 1: Superior tube (SXR-130-15-0.5)
* Type 2: C.E.I tube (OX/115-05)
3CLASS 1 LASER PRODUCT Label

2. General Information
8 PaX-i3D Green Premium™ User Manual
No. Item
4X-ray CAUTION Label
- X-ray / Attention: X-ray on when equipment in operation.
5
Wheelchair Height Limit CAUTION Label
- In case a wheelchair must be used, the overall height of the wheelchai
r
must not exceed the designated line.

3. Warnings and Precautions
PCT-90LH User Manual 9
ENGLISH
3. Warnings and Precautions
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:
-has read and understood the User Manual.
-be familiar with the fundamental structure and functions of this equipment.
-be able to recognize 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 at all times
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.

3. Warnings and Precautions
10 PaX-i3D Green Premium™ User Manual
Observe all local fire regulations. Always keep a fire extinguisher near the
equipment.
The operator of this equipment must be familiar with this equipment’s emergency
protocols.
Ensure that this equipment is kept away from water, moisture, or foreign
substances at all times.
If this product is exposed to water, moisture, or a foreign substance, immediately
turn off main power of the equipment and contact your VATE CH technical support
representative.
If there are signs of oil leakage, immediately cease all operations of this
equipment and contact your VATE CH 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 a sufficient amount of space around the PC to allow for proper
ventilation.

3. Warnings and Precautions
PCT-90LH User Manual 11
ENGLISH
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.
All removable patient support components (the Bite Block, the Chinrest, the
Headrest) can be cleaned using alcohol-based cleaning solutions.
Clean the Support Handles by using alcohol-based cleaning solutions before
taking photos of next patient.
Other surfaces of the equipment, including the Touch Screen, can be cleaned
using a soft cloth dampened with a mild cleaning solution.
New hygiene cover must be provided for each new patient to prevent the
transmission of communicable disease.
Do not use aerosol or spray cleaning agents directly on the surface of
the equipment.
Condensation
Extreme 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 acquisition of next image.
-Mode of operation: Continuous operation with intermittent loading
-Exposure time: Max. 18 s / Resting time: 10 min.
-Column operation time: 1 min / Resting time: 9 min.
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).

3. Warnings and Precautions
12 PaX-i3D Green Premium™ User Manual
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.
Emergency stop
If a problem occurs during image acquisition, press the red Emergency Stop
Switch to immediately stop all moving parts and cut off all power to the
equipment. (Emergency Stop Switch is located under the Handle 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 system is in full working order.
Always ensure that equipment movement is not obstructed by the patient’s
clothing, medical device (such as a wheelchair), or the patient themselves.
Do not leave the patient unattended around the equipment.
Remove all radio-controlled devices, mobile phones, etc. from the X-ray room
prior to image acquisition as these objects may cause the equipment to
malfunction.
Modifying the equipment
Modifying the equipment in any way which may affects 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.

3. Warnings and Precautions
PCT-90LH User Manual 13
ENGLISH
3.2 Electricity-related Safety Precautions
To avoid 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 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 15.3 Electromagnetic Compatibility (EMC)
Information.
Please also observe the Electro-Static Discharge (ESD) protective measures
described.

3. Warnings and Precautions
14 PaX-i3D Green Premium™ User Manual
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 wrist band for grounding