Postal Code: 445-170
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea
(PHT-30LFO)
User Manual Version 1.2.0
English
"i" stands for 'innovation', one of the
core values of VATECH, which aims
to expand accessibility of medical
solutions to more people.
Notice
Thank you for purchasing the PaX-i3D Smart extra-oral imaging system.
The PaX-i3D Smart is an advanced digital dental diagnostic system that incorporates PANO,
CEPH, and CBCT imaging capabilities into a single system.
This manual describes how to operate the PaX-i3D Smart system. It is recommended that
you thoroughly familiarize yourself with this manual in order to make the most effective use of
this equipment.
Observe all cautions, safety messages and warnings which appear in this manual.
Due to a constant technological improvement, the manual may not contain the most updated
information, subjecting to change without prior notice to the persons concerned. For further
information not covered in this manual, please contact us at:
English
VATECH Co., Ltd.
Phone: +82-1588-9510
E-mail: gcs@vatech.co.kr
This document is originally written in English.
The PaX-i3D Smart is referred to as Equipment in this manual.
Manual Name: PaX-i3D Smart (Model: PHT- 30LFO) User Manual
Version: 1.2.0
Publication Date: 2015-2
PaX-i3D Smart
v I
Table of Contents
1. General Information .............................................................................2
1.1 Manufacturer’s Liability .........................................................................................2
1.2 Owner and Operator’s Obligations ........................................................................ 2
1.3 Conventions in this Manual ................................................................................... 3
1.4 Marks and Symbols ..............................................................................................4
2. Warnings and Precautions ..................................................................6
2.1 General Safety Precautions ...................................................................................6
2.2 Electricity-related Safety Precautions ....................................................................9
2.3 Radiation Safety ................................................................................................. 11
2.4 Warnings ............................................................................................................ 12
3. Imaging System Overview ................................................................. 18
3.1 Introduction ........................................................................................................ 18
3.2 Imaging System Configuration ............................................................................ 21
3.3 Equipment Overview ........................................................................................... 23
4. Imaging Software Overview ..............................................................32
4.1 PC Specifications ............................................................................................... 32
4.2 EasyDent / EzDent-i .......................................................................................... 34
4.3 Console Software ............................................................................................... 35
5. Getting Started ..................................................................................42
5.1 Turning On Equipment ........................................................................................ 42
5.2 Running the Image Viewer .................................................................................. 44
5.3 Initiating the Console Software ............................................................................50
6. Acquiring PANO images ....................................................................54
6.1 Setting Exposure Parameters ............................................................................59
6.2 Patient Positioning .............................................................................................. 63
6.3 X-ray Exposure ................................................................................................... 77
6.4 Finishing Scan .................................................................................................... 78
6.5 Confirming Image ............................................................................................... 78
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Table of Contents
7. Acquiring CEPH images ...................................................................80
7.1 Setting Exposure Parameters .............................................................................82
7.2 Patient Positioning .............................................................................................. 85
7.3 X-ray Exposure ................................................................................................... 95
7.4 Finishing Scan .................................................................................................... 96
7.5 Confirming Image ............................................................................................... 96
8. Acquiring CT Images ...........................................................................98
8.1 Setting Exposure Parameters .............................................................................98
8.2 Patient Positioning ............................................................................................ 101
8.3 X-ray Exposure ................................................................................................. 106
8.4 Finishing Scan .................................................................................................. 108
8.5 Confirming Image ............................................................................................. 108
9. Troubleshooting ............................................................................... 110
10. Cleaning and Maintenance .............................................................. 114
10.1 Cleaning ........................................................................................................... 114
10.2 Maintenance ....................................................................................................115
English
11. Disposing of the Unit ....................................................................... 118
12. Technical Specifications .................................................................120
12.1 Mechanical Specifications ................................................................................120
12.2 Technical Specifications ................................................................................... 125
12.3 Electrical Specifications .................................................................................... 129
12.4 Environmental Specifications ............................................................................129
13. Appendices ......................................................................................132
13.1 Recommended X-ray Exposure Table ...............................................................132
13.2 X-ray Dose Data ............................................................................................... 135
13.3 Electromagnetic Compatibility (EMC) Information .............................................139
13.4 Acquiring image for the pediatric dental patient ................................................. 142
13.5 Abbreviations ..................................................................................................145
PaX-i3D Smart
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1
General Information
1.1 Manufacturer’s Liability .....................2
1.2 Owner and Operator’s Obligations ....2
1.3 Conventions in this Manual ...............3
1.4 Marks and Symbols ..........................4
1. General Information
1.1
Manufacturer’s Liability
The manufacturers and/or retailers of this equipment assume responsibility for the safe
and normal operation of this product only when:
● The equipment has been installed by a VATECH authorized technician.
● The equipment has been installed in accordance with all of the cautions and
conditions for installation.
● Genuine VATECH approved equipment and components have been used at all
times.
● All maintenance and repairs have been performed by a VATECH authorized agent.
● The equipment has been used normally in accordance with the user’s manual.
● The equipment damage or malfunction is not the result of an error on the part of the
owner or operator.
1.2
Owner and Operator’s Obligations
● The owner of this equipment shall perform constancy tests at regular intervals in
order to ensure patient and operator safety. These tests must be performed in
accordance with local X-ray safety regulations.
● The owner of this equipment shall perform regular inspection and maintenance of
the mechanical and electrical components in this equipment to ensure safe and
consistent operation (IEC 60601-1). The owner of this equipment shall ensure
inspection and cleaning works are performed in accordance with the maintenance
schedule outlined in Chapter 8 Cleaning and Maintenance.
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1. General Information
1.3
Conventions in this Manual
The following symbols are used throughout this manual. Make sure that you fully
understand each symbol and follow the instructions which accompany it.
To prevent personal injury and/or damage to the equipment, please observe all warnings
and safety information included in this document.
Indicates information that should be followed with
WARNING
CAUTION
X-ray
IMPORTANT
the utmost care. Failure to comply with a warning
may result in severe damage to the equipment or
physical injury to the operator and/or patient.
Indicates a situation that demands prompt and
careful action, a specific remedy, or emergency
attention.
Indicates a possible danger of exposure to
radiation.
Indicates a situation or action that could potentially
cause problems to the equipment and/or its
operation.
English
NOTE
SINGLE USE
Emphasizes important information or provide
useful tips and hints.
Indicates a component which must be replaced for
each new patient.
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1. General Information
1.4
Marks and Symbols
Symbols Description Location
Alternate current -
Attention: consult accompanying documents Label
Dangerous voltage Power board
Protective earth (Ground) Power board
Off (power: disconnect from the main switch) Main switch
On (power: connect to the main switc Main switch
IEC60601-1
Degree of Protection from Electric Shock
TYPE B Equipment
Label
CLASS 1 LASER PRODUCT
Radiation hazard Label
EC representative Label
The CE symbol indicates that this product complies with
the European Directive for Medical Devices 93/42/EEC
as amended by 2007/47/EC as a class IIb device.
UL mark: UL 60601-1 / CAN/CSA
C22.2 No.601.1 3ZY1
Address where the equipment was manufactured Label
This symbol indicates that electrical and electronic
equipment must not be disposed of as unsorted
municipal waste and must be collected separately
This symbol warns ESD hazard.
This symbol indicates that this equipment is classified as
a CLASS 1 LASER PRODUCT in accordance with IEC
60825-1 ED.1 regulations.
Date of manufacture Label
Refer to Instruction manual Label
Label
Label
Label
MCU board/Board
package
Label
PaX-i3D Smart
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Warnings and
2
Precautions
2.1 General Safety Precautions ...............6
2.2 Electricity-related Safety Precautions 9
2.3 Radiation Safety ..............................11
2.4 Warnings .........................................12
2. Warnings and Precautions
Be sure to strictly observe all warnings and safety instructions included
in this manual.
2.1
General Safety Precautions
Operator qualifications
❚
This equipment may only be operated by personnel fully trained in its operation.
● To operate this equipment, all operators must:
— have read and understood the user’s manual
— be familiar with the fundamental structure and functions of this equipment
— be able to recognize irregularities in the operation of this equipment and implement
appropriate measures to remedy such irregularities.
General safety precautions
❚
● Follow the instructions specified in this manual to ensure the safety of both the
patient and the operator.
● The operator must maintain visual contact with the patient at all times during
imaging.
● Do not open or remove the cover panels on this equipment. Always have a trained
and authorized service technician carry out inspection and maintenance of this
equipment.
● Do not place foreign objects on this equipment at any time.
● Do not place any objects within this equipment’s field of operation.
● Do not push or pull the equipment. If equipment overbalances, resulting in the risk of
physical injuries or property damage.
● Operators must ask the patient to remain still until the equipment arm has stopped
moving and the reset motion is complete.
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2. Warnings and Precautions
● Observe all local fire regulations. Always keep a fire extinguisher near the equipment.
● The operator of this equipment must be familiar with this equipment’s emergency
protocols.
● Ensure that this equipment is kept away from water, moisture, or foreign substances
at all times.
● If this product is exposed to water, moisture, or a foreign substance, immediately
turn off all power to the equipment and contact your VATECH technical support
representative.
● Immediately cease all operation of this equipment if there are signs of oil leakage and
contact you VATECH technical support representative.
Ventilation
❚
● Do not obstruct the equipment’s ventilation for air opening. Improper ventilation
could result in the equipment overheating due to a lack of air circulation.
● Do not spray any type of liquid or aerosol on this equipment as this may penetrate
the system and damage the electrical and mechanical components inside.
English
● Always leave a sufficient amount of space around the PC to allow for proper
ventilation.
Hygiene
❚
Always disconnect the equipment from the power outlet when cleaning
the surfaces of the equipment.
● All removable patient support components (bite block, chin support, temple
supports) can be cleaned using alcohol-based cleaning solutions.
● Patient support handles can be cleaned using alcohol-based cleaning solutions.
● Other surfaces of the equipment can be cleaned using a soft cloth dampened with a
mild cleaning solution.
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2. Warnings and Precautions
● New hygiene cover must be provided for each new patient to prevent the
transmission of communicable disease.
Do not use aerosol or spray cleaning agents directly on the surface of the
equipment.
Condensation
❚
● Extreme fluctuations in temperature may cause condensation to develop inside the
equipment. Do not turn on the equipment until it has reached room temperature.
Cooling
❚
● Allow the proper amount of cool down time (for the X-ray tube to cool down) to
elapse between each image acquisition.
— Mode of operation: Continuous operation with intermittent loading.
— Exposure time: Max. 18 s / Resting time: 5 min.
— Column operation time: 1 min / Resting time: 9 min
● If the temperature inside the tube head reaches 60 °C, X-ray exposure will cease
and an error message will be displayed. Normal X-ray capabilities will resume after
the generator reaches 58 °C (136.4 °F).
● If the fan (optional) is installed, it operates automatically when the temperature
surrounding the tube head reaches the pre-defined level: 40 °C (104 °F). The set
point temperature is configurable.
Turning the equipment on / adjusting the height of the
❚
equipment
● Do not position the patient in the equipment while it is initiating as the patient could
be injured if the equipment malfunctions.
● Ensure that the patient is kept clear of the mechanism while adjusting the height of
the equipment.
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2. Warnings and Precautions
Emergency stop
❚
● If a problem occurs during image acquisition, press the red emergency stop button
to immediately stop all moving parts and cut off all power to the equipment.
Trouble-free operation
❚
● Never use this equipment in an environment that is susceptible to explosion.
● Always operate the equipment within a temperature range of 10 °C to 35 °C (50 °F
to 95 °F) for the safe operation. Image quality may deteriorate if the equipment is
operated outside of this range.
● Always allow the equipment sufficient time to warm up (while switched on) if it has
been exposed to temperatures of below 10 °C (50 °F).
● Only perform X-rays of patients if system is in full working order.
● Always ensure that equipment movement is not obstructed by the patient’s clothing,
medical device (such as a wheelchair), or the patient themselves.
● Do not leave the patient unattended around the equipment.
● Remove all radio-controlled devices, mobile phones, etc. from the X-ray room prior
to image acquisition as these objects may cause the equipment to malfunction.
English
Modifying the equipment
❚
● Modifying the equipment in any way which may affect the safety of the operator,
patient or other persons is prohibited by law.
● No part of this equipment is serviceable by the user. All maintenance and repair of
this equipment must be performed by a qualified service technician.
● This product may only be operated with original VATECH accessories or third-party
accessories expressly approved by VATECH.
2.2
Electricity-related Safety Precautions
● Check the status of the power source, PC and cables prior to operating the
equipment.
● Ensure that the on/off switch is set to off when the equipment is not in use.
● Always disconnect the power supply before cleaning the equipment.
● Always keep electrical cords away from hot appliances or radiators.
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2. Warnings and Precautions
● DO NOT place the PC or peripheral equipment connected to the PC in the
immediate vicinity of the patient.
● The equipment and PC should be connected to a common protective earth.
● Never overload the equipment’s circuit by sharing it with too many appliances.
● Use the same power circuit for the PC and the equipment.
Combining this equipment with other devices
❚
● Do not connect this equipment to devices which are not part of the system.
● Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO) or
extension cord.
Electromagnetic compatibility
❚
● This equipment complies with IEC standard 60601-1-2.
Medical electrical equipment is subject to special EMC preventive measures. It must be installed
and operated as specified in the Installation Requirements document.
If high-voltage systems, radio link systems or MRI systems are located within 5 m of the unit,
please observe the specifications stated in the installation requirements.
Portable and mobile RF communications equipment may interfere with medical electrical
equipment. Therefore, the use of mobile wireless phones in medical offices or hospital
environments must be prohibited.
For more details, refer to the document Electromagnetic Compatibility Information.
Please also observe the ESD (ESD: Electro-Static Discharge) protective measures described
below.
Static Discharge
❚
● Connector pins or sockets bearing ESD warning labels must not be touched or
interconnected without observing ESD protective measures.
Electrostatic discharge (ESD)
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2. Warnings and Precautions
ESD protective measures include
❚
● Procedures for preventing electrostatic charge build-up (e.g. air conditioning, air
moistening, conductive floor coverings and non-synthetic clothing)
● Discharge the electrostatic charges of your own body on the frame of the UNIT, the
protective ground wire or large metallic objects.
● Use the wrist band for grounding.
2.3
Radiation Safety
English
Since rules and regulations concerning radiation safety differ between
countries, it is the responsibility of the owner and/or operator of this equipment
to comply with all applicable rules and regulations concerning radiation safety
and protection in their area.
● The operator must remain outside a shielded room during X-ray exposure in order to
protect himself/herself from radiation.
● The patient must wear a lead apron with neck and thyroid protection during X-ray
exposure.
● Children and pregnant women must consult with a doctor before X-ray exposure.
● This equipment must be housed inside an X-ray shielded room.
● During imaging; the operator must maintain visual contact with the patient from
outside the shielded area.
● The operator should continuously check the status of the patient and the equipment
during imaging.
PaX-i3D Smart
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2. Warnings and Precautions
● The operator must immediately stop imaging if the equipment malfunctions.
● The operator should be at least 2 m (6 feet) away from the equipment during
imaging.
As a manufacturer of radiology equipment that conforms to stringent protection
standards around the world, we guarantee the maximum degree of protection
against radiation hazards for our equipment.
2.4
Warnings
The following warning statements should be obeyed with the utmost care. Failure to
follow these warnings may cause severe damage to the equipment or physical injuries to
the patient and/or operator.
X-ray equipment is hazardous to patient and the operator if proper exposure
safety measures and/or operating instructions are not observed.
It is important to read this user manual carefully and strictly abide by all
warnings and cautions stated within it.
● 3D image should not be used for screening examinations. Each exam must
be justified by demonstrating that the benefits outweigh the risk.
● Where it is likely that evaluation of soft tissues will be required as part of the
patient’s radiological assessment, conventional medical CT or MR should be
used instead of dental cone beam imaging.
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2. Warnings and Precautions
● PaX-i3D Smart system, like other medical equipment, uses high-frequency
electrical signals that can interfere with implantable devices such as
pacemakers and implantable cardioverter-defibrillators(ICDs). If the patient
has such an implantable device, you should be aware of any interference in
its operation and immediately power off the Dental X-ray system.
● PaX-i3D Smart system is designed to withstand the effects of defibrillation.
However, when possible, disconnect the Dental X-ray systems during
defibrillation since a malfunction of the safety controls could otherwise result
in electrical burns for the patient.
Federal law restricts this device to sale by or on the order of dentist or with the
descriptive designation of any other practitioner licensed by the law of the State
in which he practices to use or order the use of the device.
Lasers
❚
English
● The system incorporates Class 1 laser products. The light localizers used in this
product are intended for correct patient positioning and must not be used for any
other purpose.
● For maximum safety, advise the patient not to look directly at the laser beam.
● While adjusting the patient, ensure that the laser beam is not directed at the patient’s
eyes.
Risk of eye injury!
Do not use this equipment with any other laser sources and do not
make any changes to the settings or processes that are described in
these operating instructions.
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2. Warnings and Precautions
Cleaning
❚
● Never expose this equipment to liquids, mists or sprays. Exposing this equipment to
liquids may cause an electrical shock or otherwise damage the system.
● Do not use spray cleaners on this equipment, as this could cause a fire.
During Operation
❚
● Never use this equipment in an environment that is susceptible to explosion.
● Do not place flammable materials near this equipment.
● Do not operate the PC while the equipment is performing an operation. Failure to
comply with this instruction may result in system malfunction.
● Immediately stop imaging if the equipment malfunctions in any way.
● If a problem occurs during imaging, press the red emergency stop button to
immediately stop all moving parts and cut off all power to the equipment’s electrical
components.
● Never touch the patient while also touching the SIP/SOP connectors.
● The medical electrical equipment or medical electrical system should not be used
adjacent to or stacked with other equipment and that if adjacent or stacked use is
necessary, the medical electrical equipment or medical electrical system should be
observed to verify normal operation in the configuration in which it will be used.
● The use of accessories, transducers and cables other than those specified, with
the exception of transducers and cables sold by the VATECH of the medical
electrical equipment or medical electrical system as replacement parts for internal
components, may result in increased EMISSIONS or decreased IMMUNITY of
EQUIPMENT or SYSTEM.
In case of electrical fire
❚
● Use only fire extinguishers designed for electrical fires to extinguish fires on this
equipment.
Liquid extinguishers, such as those which use water, could damage the equipment and/or
cause injury.
● Unplug the equipment’s power cable before extinguishing any fire.
PaX-i3D Smart
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2. Warnings and Precautions
Installation
❚
● In order to avoid improperly balanced equipment, install the device on a flat surface
to maintain stability.
● If the equipment is not stable, property damage and/or personal injury may occur.
● Do not push or pull the equipment.
● Equipment should only be installed by an authorized technician, complying with
proper installation procedures.
Security Capabilities
❚
● It is recommended to install and operate EasyDent/EzDent-i SW within secure
operating environment that allows only authorized users to access and the system
network is equipped with Window firewall built-in Windows system, windows
Defender antispyware tools and other commonly used 3rd party security tools and
application systems.
● The latest updates for anti-virus software and a firewall is recommended.
● The software can be updated by the manufacturer only. Unauthorized software
update through a third party, not the manufacturer, is strictly prohibited. For cyber
security issues related to the software and medical devices, please contact the
manufacturer.
English
PaX-i3D Smart
15 I
Imaging System
3
Overview
3.1 Introduction ...........................18
3.2 Imaging System Configuration ..
..............................................21
3.3 Equipment Overview .............23
3. Imaging System Overview
3.1
Introduction
PaX-i3D Smart is an advanced digital dental diagnostic system that incorporates
Panoramic (PANO), Cephalometric (CEPH), and CBCT imaging capabilities into a single
system.
3.1.1
Intended Use
PaX-i3D Smart(PHT-30LFO) is a computed tomography x-ray system intended to
produce panoramic, cephalometric or cross-sectional images of the oral anatomy on
a real time basis by computer reconstruction of x-ray image data from the same axial
plane taken at different angles. It provides diagnostic details of the anatomic structures
by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise
treatment planning in adult and pediatric dentistry . The device is operated and used by
physicians, dentists, and x-ray technicians.
3.1.2
System Components
3.1.3
● PaX-i3D Smart digital x-ray equipment
● PC system
● Imagaing Software
● EasyDent / EzDent-i: 2D viewer and patient management software
● Ez3D plus / Ez3D-i: 3D viewer and image analysis software
Features
● Low dose Imaging
● 3D Pan and Real 2D image acquisition by single scan
● 3D Viewer: 3D imaging supports precision analysis and diagnosis
● Supports the international digital imaging standard DICOM
PaX-i3D Smart
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3. Imaging System Overview
3.1.3
PaX-i3D Smart Options
Model Item Sensor
SP
PANO+CBCT PANO/CT Xmaru1404CF
SC
PANO+CBCT +CEPH
OS
PANO+CBCT +CEPH
OP
PANO+CBCT +CEPH
3.1.5
Standards and Regulations
Standards
❚
PaX-i3D Smart was designed and developed to comply with the following international
standards and regulations.
PANO/CT Xmaru1404CF
CEPH Xmaru2301CF
PANO/CT Xmaru1404CF
CEPH 910SGA
PANO/CT Xmaru1404CF
CEPH 1210SGA
English
IEC/EN 60601-1(3rd), UL 60601-1(1st), IEC/EN 60601-1-3, IEC 60601-2-63
21 CFR 1020.30, 31, 33
NEMA Standard publication PS 3.1-3.18, 2008
This is Class11b equipment and received the CE mark for
regulations compliance in accordance with the revised Medical
Devices Directive 93/42 EEC.
This equipment received the UL certification mark in accordance
with UL 60601-1/CAN/CSA C22.2 No.601.1 regulations.
PaX-i3D Smart
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3. Imaging System Overview
Classification (IEC60601-1 6.1)
❚
● Degree of protection against the ingress of water: Ordinary Equipment: IPX0
● Degree of protection against electric shock: Class 1 equipment, Type B Applied
Parts
PaX-i3D Smart
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3. Imaging System Overview
F
O
E
e
F
O
3.2
Imaging System Configuration
PaX-i3D Smart
Exposure switch
SIGNAL INPUT
WARNING SYSTEM BOX
LAMP INPUT LAMP OUTPUT
Warning system panel
Warning lamp
(Optional)
Door interlock
Fiber Optice Cable 10m(32.8'): SCAN CEPH(Optional)
iber
Ethernet Cable(CAT5e): OneShot CEPH(Optional)
thern
iber
Fiber Optic Cable 10m(32.8'): PANO, CT
PC w/ imaging and
image viewer programs
English
PaX-i3D Smart
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3. Imaging System Overview
PC Signal Input / Output
❚
No. Parts
1 3D Viewer License Key
2 Video out
3 Fiber optic cable in / out x 2 (PANO/CT, CEPH)
4 Ethernet cable(CAT5e) for OneShot CEPH(optional)
PaX-i3D Smart
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3. Imaging System Overview
3.3
-
Equipment Overview
Scan CEPH
Oneshot CEPH
English
-
PaX-i3D Smart
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