Vatech PaX-i3D Smart User manual

(PHT-30LFO)
HARDWARE and SOFTWARE
English
Installation Manual Version 1.0.0

Pax-i3D Smart(PHT-30LFO) Installation Manual
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Notice to the Installers
Notice
This manual covers the installation procedures for the PaX-i3D Smart dental X-Ray unit. An installation
manual and user manual are shipped with each hardware unit.
Brand name: PaX-i3D Smart (Model: PHT-30LFO)
Manufactured by : VATECH Co., Ltd.
In this manual, Equipment refers to the PaX-i3D Smart.
In abberviated forms, C T, CEPH and PANO denote Computed Tomography, Cephalometric and
Panoramic, respectively. They are interchangeably used.
The “Optional” in this manual means that the function or features are left to customer’s or user’s choice
Thorough review of this manual is recommended before installation to ensure proper installation of this
equipment. The PaX-i3D Smart is in steady improvement. The information contained in this manual
may be subject to change without notice, justication or notication of the persons concerned.
All brand names and logos used in this manual are copyrighted.
For further information not covered in this manual or in the accompanying documentation, please
contact us with any method listed below:
Telephone: [phone]
E-Mail: [email protected]
Website: http://www.vatech.co.kr
Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea

Pax-i3D Smart(PHT-30LFO) Installation Manual 05
Notice to the Installers
Important Notes
Moisture could be built up on the equipment from a sudden temperature change
inside and outside the installation room. Allow at least an hour before turning
ON the equipment to avoid condensation.
1. In order to avoid improperly balanced equipment, install the device on a at
surface to maintain stability.
2. If the equipment is not stable, property damage and/or personal injury may
occur.
3. Do not push or pull the equipment.
4. Equipment should only be installed by an authorized technician, complying
with proper installation procedures.
Failure to read and understand the information provided in this manual may
result in physical injury, damage to the equipment or equipment failure. Please
read each CHAPTER in its entirety and understand the information therein
before attempting any of the installation procedures.

Pax-i3D Smart(PHT-30LFO) Installation Manual
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Notice to the Installers
Conventions Used in this Guide
The following symbols are used throughout this manual to emphasize information or indicate a
potential risk to the equipment or user. Make sure that you fully understand each symbol and obey the
instructions which appear to the right of the symbol.
Notes help you optimize system performance. Carefully read each note to ensure
that the equipment is used to its full potential.
Cautions indicate a situation that demands prompt but careful action, remedy or
emergency attention.
Warnings indicate information that should be followed with the utmost precision.
Failure to comply with warnings may result in severe damage to the equipment and/
or physical injuries to the patient or operator.
Radiation symbols indicate a possible danger from exposure to radiation.
Important symbols indicate a compulsory action or instruction.
ESD susceptibility symbols indicate that an item is susceptible to damage from
electrostatic discharges.

Pax-i3D Smart(PHT-30LFO) Installation Manual 07
Notice to the Installers
Never touch or hold the sensor or tube head areas while moving, installing
or operating the equipment.
Sensor
Tube head
Handle frame

Pax-i3D Smart(PHT-30LFO) Installation Manual
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Notice to the Installers
Do not step on the base unit while installing or operating the equipment.
Do not use the electrical power drill during installation unless it is allowed
to do so.
Recommended holding area during transportation(OK)
Four installers are required to install the equipment safely.

Pax-i3D Smart(PHT-30LFO) Installation Manual 09
Notice to the Installers
Locations of the Power and Emergency Switches
EMERGENCY SWITCH
ON/OFF SWITCH

Pax-i3D Smart(PHT-30LFO) Installation Manual
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Notice to the Installers
Cautions
1. It is critical that installers read and understand the installation instructions
fully before installation.
2. The installer must confirm that the system is installed according to
the instructions provided by this manual and perform the appropriate
procedures therein.
3. If the equipment has been stored at temperatures of below 10℃(50℉)
for more than a couple of hours, allow the equipment to reach room
temperature before applying mains voltage.
4. Installation and related work must only be performed by people authorized
by VATECH.
5. Do not connect any items or equipment to this system which are not part of
the system: IEC60601-1-1 (3rd edition: 2005).
6. Any equipment not approved by VATECH must comply with the applicable
standards: IEC 60950-1 (2nd edition: 2005) for IT equipment (Ex: PC) and
IEC 60601-1 (3rd edition: 2005) for medical electrical equipment.
7. All operators of this equipment are responsible for ensuring that the
requirements outlined in IEC 60601-1-1 (3rd edition: 2005): Safety
Requirements for Medical Electrical Equipment are fully met to ensure the
safety of patients, operators and the environment.
8. Never touch sensitive areas such as sensors during installation. These
areas are indicated at the applicable stages during the installation
procedures.
9. Use of wireless phones may interfere with the operation of this equipment.
10. Use an ESD (electrostatic sensitive device) wrist band during installation
and connect it to a ground wire.
11. Touch a ground point to discharge static electricity before handling PCB
boards.

Pax-i3D Smart(PHT-30LFO) Installation Manual 11
Notice to the Installers
Installation Site
1. The PC monitor, emergency cut off switch and X-Ray exposure switch
should be installed in the vicinity of the operator so that he or she can
manage them simultaneously in an emergency.
2. Proper shielding of the room is essential: Since these requirements vary
depending on the country, it is the installer’s responsibilities to verify that
all applicable radiation safety requirements are met.
3. This equipment should not be installed in the immediate vicinity of other
devices.
4. Do not install the equipment in an area that is exposed to strong
electromagnetic elds.
5. Do not install this system in an area where there is the risk of an explosion.
6. The electrical installation of this system shall comply with all local code
requirements for electro-medical systems: IEC 60364-7-710:2002.
7. It is strongly recommended that a UPS be installed at the same time as the
equipment.
8. The equipment, PC, and all peripheral devices must be well grounded
Warnings Regarding X-Ray Radiation
1. Failure to install this equipment in an approved location may be dangerous
to the patient and operator.
2. Stationary radiation shielding must be installed to protect the operator from
radiation.
3. The X-Ray system may cause injury to the patient if improperly used. Obey
all federal and municipal standards regarding radiation safety.
4. When exposing the patient to the X-Ray, the operator must be behind a
protective wall or take other protective actions. The operator should remain
at least 2 m (7 feet) away from the X-Ray when pressing the exposure
switch and observe the patient and capture-progression.
5. Operators must provide protective clothing to the patient before X-Ray
capturing. Pregnant women must consult with a doctor prior to being
exposed to an X-Ray.

Pax-i3D Smart(PHT-30LFO) Installation Manual
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Notice to the Installers
This equipment complies with the following standards:
IEC60601-1-1:2005 Standard Safety Requirements for Medical Electrical
Equipment
IEC 60601-1-2:2005 Electromagnetic Interference
IEC 60601-1-3:2005 Radiation Protection
IEC 60601-1:2005 Standards for Medical Electrical Equipment
IEC 60950-1: 2nd edition:2005 Standards for Information Technology
Equipment
IEC60601-2-7 and IEC60601-2-28: X-Ray Tube Heads
IEC60364-7-710: 2002: Local Code Requirements for Electro-medical System
Installation
1. IEC 60601-1-1:2005 regulation shall be met to their full extent for the
safety of the patients, operators and the environment—when any
person assemble or modify a medical electrical system by combing it
with other equipmentt.
2. Any equipment not provided by VATECH can be connected when the
following standards are complied with: IEC 60950-1 and IEC 60601-1
3. The electrical installation shall comply with local code requirements for
electro-medical systems: IEC 60364-7-710: 2002.

Pax-i3D Smart(PHT-30LFO) Installation Manual 13
Table of Contents
TABLE OF CONTENTS
1 Introduction ........................................................................................ 15
1.1 Manufacturer’s Liability....................................................................................................16
1.2 Customer’s Responsibility ...............................................................................................16
1.3 Marks & Symbols.............................................................................................................17
1.4 Standards and Regulations ............................................................................................18
2 Choosing an Installation Site............................................................ 19
2.1 Room Requirements .......................................................................................................20
2.2 Specications for Electrical Installation ..........................................................................23
2.3 Electrical Requirements ..................................................................................................23
2.4 Temperature and Humidity ..............................................................................................25
2.5 Exposure Switch Installation Options ..............................................................................25
2.6 Installation Versions.........................................................................................................27
2.7 Installing the Warning Lamp and Door Interlock Switch ..................................................28
2.8 Installing the Emergency Stop Switch .............................................................................28
3 Before Installing the System............................................................. 29
3.1 Required Tools.................................................................................................................30
3.2 Checking the ShockWatch and TiltWatch Indicators .......................................................32
3.3 Unpacking the Boxes.......................................................................................................33
3.4 Checking the Parts ..........................................................................................................41
4 Installing the Equipment: Floor Standing (Optional)...................... 47
4.1 Assembling the Base and Main Units..............................................................................48
4.2 Installing the CEPH Unit (Optional) .................................................................................51
4.3 Connecting the Cables to the Equipment........................................................................54
4.4 Installing the Wall and Column Brackets .........................................................................55
4.5 Fixing the base (Optional) ...............................................................................................59
4.6 Removing the Transportation Safety Bolts ......................................................................62
4.7 Leveling the Equipment...................................................................................................64
4.8 Tightening the Bolts rmly ..............................................................................................66
5 Completing Miscellaneous Works.................................................... 67
5.1 Assembling Various Covers.............................................................................................68
5.2 Assembling Temple and Chin Supports...........................................................................70
5.3 Installing the Switch Holders ...........................................................................................71

Pax-i3D Smart(PHT-30LFO) Installation Manual
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Table of Contents
6 Setting up PC...................................................................................... 73
6.1 Direct Connection Diagram .............................................................................................74
6.2 The Recommended PC Requirements............................................................................75
6.3 Installing the Internal Peripherals ....................................................................................78
6.4 Connecting the Cables to PC ..........................................................................................80
7 Setting up PC's Environment Variables ........................................... 83
7.1 Before Beginning ............................................................................................................84
7.2 Checking PC BIOS Settings ...........................................................................................84
7.3 Turning the rewall off ....................................................................................................85
7.4 Setting up the Power Mangement Options .....................................................................87
7.5 Turning off the User Account Control...............................................................................89
7.6 Setting Folder exclusions with Anti-virus Software .........................................................91
8 Installing Software ............................................................................. 93
8.1 Before Beginning.............................................................................................................94
8.2 Software Installation Flow...............................................................................................95
8.3 Installing Image Viewer Program ....................................................................................95
8.4 Installing the installShield ................................................................................................96
8.5 Setting up the User-specic Information........................................................................106
8.5.1 When EasyDent4 is installed ..............................................................................106
8.5.2 When EzDent -i is installed .................................................................................113
8.5.3 Conguring the parameters ................................................................................116
8.6 Setting Up the IP Address for the OS CEPH Sensor (Optional)....................................123
9 Acquiring a Test Image .................................................................... 127
9.1 Aligning the collimator ...................................................................................................128
9.1.1 PANO collimator Alignment.................................................................................128
9.1.2 CBCT collimator Alignment .................................................................................132
9.2 Acquiring the test image................................................................................................136
10 Technical Specications.................................................................. 137
Appendix........................................................................................... 143
A. Installing the Warning Lamp and Door Interlock Switch.....................................................144
B. Installing the Emergency Switch ........................................................................................147
C. Limiting the Column Height................................................................................................148
D. Connecting the Third-party Exposure Switch(Optional).....................................................152
E. Checking PC BIOS Settings...............................................................................................153
F. Installation checklist............................................................................................................154

Introduction
1.1 Manufacturer’s Liability ...................................................16
1.2 Customer’s Responsibility ............................................... 16
1.3 Marks & Symbols ............................................................ 17
1.4 Standards and Regulations ............................................ 18
1

Pax-i3D Smart(PHT-30LFO) Installation Manual
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1 Introduction
1.1 Manufacturer’s Liability
As the manufacturer, VATECH assumes liability for the safe and reliable installation and operation of
this equipment only when:
●Equipment installation, including software installation, was carried out by an authorized agent in
accordance with this installation manual.
● Electrical installation was carried out in accordance with the appropriate requirements specied
in IEC-60363.
●Genuine original or approved replacement parts are used.
●Maintenance/repair service has been performed by a qualified technician(s) from one of our
authorized agents.
●The equipment has been used under normal condition in accordance with the user's manual.
●PC Software has been properly used in accordance with the manufacturer’s installation
instructions and user manuals.
1.2 Customer’s Responsibility
Site planning and preparation are the responsibility of the customer. The following points should be
considered fundamentally important to all customers of this product:
●Install all required materials prior to delivery of the system.
● Complete the oor, ceiling and walls of the room before installing the equipment.
●Install proper sized junction boxes, with covers, at the necessary locations.
●Install a mains power with the proper voltage output and an adequate kVA rating.
● Install the circuit breaker specied by this manual.
●Provide the installer(s) with the current dimensions of the room including the hall way and entry
door sizes.
●The customer must have an electrician install more than two power outlets in the room.

Pax-i3D Smart(PHT-30LFO) Installation Manual 17
1 Introduction
1.3 Marks & 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 switch) Main switch
TYPE B Equipment Label
Radiation hazard Label
EC REP EC representative Manual
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
This equipmentis UL-marked according to UL60601-1 and
CAN/CSA C22.2 No. 601.1 Label
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.
Label
This symbol warns the user to take precautions when
dealing with electronic components which are sensitive to
static charges
MCU board
packaging
This symbol indicates that this equipment is classied as
a CLASS 1 LASER PRODUCT in accordance with IEC
60825-1 ED.1 regulations.
Label

Pax-i3D Smart(PHT-30LFO) Installation Manual
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1 Introduction
1.4 Standards and Regulations
A. Standards
This X-Ray equipment complies with the following standards:
IEC/EN/UL 60601-1, IEC/EN 60601-1-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-7,
IEC/EN 60601-2-28, IEC/EN 60601-2-32, IEC/EN 60601-2-44, ISO 9001, ISO 13485
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.
B. Classication: (IEC60601-1 6.1)
Protection against the ingress of water: IEC60529 edition 2.1
Ordinary Equipment: IPX0
Protection against electric shock:
Class Ⅰequipment, Type B Applied Parts

Choosing an Installation Site
2.1 Room Requirements ......................................................20
2.2 Specifications for Electrical Installation ........................... 23
2.3 Electrical Requirements ................................................. 23
2.4 Temperature and Humidity .............................................25
2.5 Exposure Switch Installation Options .............................. 25
2.6 Installation Versions ........................................................27
2.7 Installing the Warning Lamp and Door Interlock Switch ... 28
2.8 Installing the Emergency Stop Switch ............................. 28
2

Pax-i3D Smart(PHT-30LFO) Installation Manual
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2 Choosing an Installation Site
2.1 Room Requirements
1. The location of this equipment should allow for high visibility of the
patient by the operator and the operator should be as near to the
patient as possible.
2. This equipment should not be installed on thick carpets for stability
reasons.
3. Anti-static oor materials should be used around the equipment.
4. The PC monitor, emergency cut off switch and X-Ray exposure switch
should be installed in the vicinity of the operator so that he or she can
manage them simultaneously in case of emergency.
Ø1020(40.2)
2500/98.4”
2500/98.4”
1482(58.3)
1914(75.4)
1165(45.9)
1321(52) 470(18.5)
With Cephalometric unit (optional): 2,500mm x 2,500mm/98.4" x 98.4" or wider