Vatech PaX-i Plus User manual

Notice
PaX-i Plus / Insight Installation Manual i
Notice
This manual covers the installation procedures for the PaX-i Plus / Insight dental X-
ray unit. The Installation Manual and the User Manual are shipped with each hardware
unit.
Brand name: PaX-i Plus / Insight (Model: PCH-30CS)
Manufactured by: VATECH Co., Ltd.
In this manual, “equipment” refers to the PaX-i Plus / Insight.
In abbreviated forms, CEPH and PANO denote Cephalometric image and Panoramic
image, respectively.
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-i Plus / Insight is in steady improvement. The
information contained in this manual may be subject to change without notice,
justification or notification of the persons concerned.
VATECH Co., Ltd. (manufacturer) reserves intellectual property rights (IPR) for this
manual and the equipment described herein. This IPR is protected by related laws and
reproduction of this manual, in part or in full, is prohibited without the prior written
consent of the Manufacturer.
This Equipment is covered by one or more of the patents and published patent
applications including US8634515, US9117301, US9486174, KR1032963,
KR1021847, KR1389841, KR1664166, EP2851004, US2017027536,
KR20170063689.
Windows 10, NVIDIA, etc. are 3rd parties’ prominent or registered trademarks
protected by related laws and these trademarks are used in this manual just only for
explanation.
For further information not covered in this manual or in the accompanying
documentations, please contact us with any methods listed below:
Telephone: [phone] / E-Mail: [e-mail]
Website: http://www.vatech.co.kr
Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do,Korea
• Manual Name: PaX-i Plus / Insight (Model: PCH-30CS) Installation Manual
• Version: 1.0
• Publication Date: 2017-06
The QR code linked to video file about the installation is provided in the cover of this
manual. The smart phone and pad which have the QR code reader application
program can be used to watch video.

Important Notes
ii PaX-i Plus / Insight Installation Manual
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.
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
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.

Table of Contents
PaX-i Plus / Insight Installation Manual iii
Table of Contents
Notice..................................................................................................................i
Important Notes ................................................................................................ii
Table of Contents..............................................................................................iii
1. Introduction ........................................................................................1
1.1 Manufacturer's Liability.....................................................................1
1.2 Customer’s Responsibility..................................................................1
1.3 Conventions in this Manual ...............................................................2
1.4 Marks and Symbols ..........................................................................8
1.5 Standards and Regulations ............................................................. 10
2. Choosing an Installation Site ............................................................11
2.1 Room Requirements....................................................................... 11
2.2 Specifications for Electrical Installation ............................................ 15
2.3 Electrical Requirement.................................................................... 15
2.4 Environmental Specifications........................................................... 17
2.5 Exposure Switch Installation Options............................................... 18
2.6 Installation Versions ....................................................................... 20
2.7Installing the Warning Lamp and Door Interlock Switch.................... 22
2.8 Installing the Emergency Stop Switch.............................................. 22
3. Before Installing the System.............................................................23
3.1 Required Tools............................................................................... 23
3.2 Checking the ShockWatch and TiltWatch Indicators.......................... 25
3.3 Unpacking Boxes............................................................................ 26
3.4 Checking the Parts ......................................................................... 33
4. Installing the Equipment: Base Stand (Optional)..............................39
4.1 Unloading the Base and Main Unit................................................... 39
4.2 Assembling the Base with the Column Unit ...................................... 42
4.3 Removing the Transportation Handle............................................... 45
4.4 Installing the Wall and Column Brackets .......................................... 46
4.5 Removing the Transportation Safety Bolts........................................ 51
4.6 Installing the CEPH Unit (Optional).................................................. 52
4.7 Fixing the Base (Optional) .............................................................. 55
4.8 Connecting the Cables to the Equipment. ........................................ 58
4.9 Leveling the Equipment .................................................................. 60
4.10 Tightening the Bolts ....................................................................... 63
5. Installing the Equipment: Wall Mount...............................................65

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iv PaX-i Plus / Insight Installation Manual
5.1 Installing the Equipmet................................................................... 65
5.2 Removing the Transportation Handle).............................................. 70
5.3 Installing the Wall and Column Brackets.......................................... 70
5.4 Removing the Transportation Safety Bolts........................................ 70
5.5 Installing the CEPH Unit (Optional).................................................. 70
5.6 Connecting the Cables to the Equipment ......................................... 70
5.7 Leveling the Equipment.................................................................. 71
5.9 Tightening the Bolts....................................................................... 74
6. Completing Miscellaneous Works......................................................75
6.1 Assembling Base Cover (Optional)................................................... 75
6.2 Assembling the Temple Supports and the Chinrest ........................... 77
6.3 Installing the Switch Holders........................................................... 78
7. Setting up PC.....................................................................................79
7.1 Direct Connection Diagram ............................................................. 79
7.2 The Recommended PC Requirements .............................................. 80
7.3 Installing the Internal Peripherals.................................................... 83
7.4 Connecting the Cables to PC........................................................... 85
8. Setting up PC’s Environment Variables............................................. 87
8.1 Before Beginning............................................................................ 87
8.2 Turning off the Firewall................................................................... 89
8.3 Setting up the Power Mangement Options ....................................... 90
8.4 Turning off the User Account Control............................................... 92
8.5 Setting Folder Exclusions with Anti-virus Software............................ 93
9. Installing Software ...........................................................................95
9.1 Before Beginning............................................................................ 95
9.2 Software Installation Flow............................................................... 96
9.3 Installing Image Viewer Program .................................................... 96
9.4 Installing the InstallPakage............................................................. 97
9.5 Setting up the User-specific Information.........................................106
10. Technical Specifications..................................................................119
10.1 Mechanical Specifications...............................................................119
10.2 Electrical Specifications..................................................................121
10.3 Environmental Specifications..........................................................122
Appendix A .................................................................................................... 123
A. Installing the Warning Lamp and Door Interlock Switch...................123
B. Installing the Emergency Stop Switch.............................................126
C. Limiting the Column Height............................................................127
D. Connecting the 3rd party Exposure Switch (Optional) .......................131

Table of Contents
PaX-i Plus / Insight Installation Manual v
E. Checking PC BIOS Settings ........................................................... 132
F. Installation Checklist .................................................................... 133

Table of Contents
vi PaX-i Plus / Insight Installation Manual

1. Introduction
PaX-i Plus / Insight Installation Manual 1
1. Introduction
1.1 Manufacturer's Liability
As the manufacturer, VATECH assumes liability for the safe and reliable installation
and operation ofthis equipment onlywhen:
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 specified 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 beconsidered fundamentally important to all customers of thisproduct:
Install all required materials prior to delivery of the system.
Complete the floor, 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 specified 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.

1. Introduction
2 PaX-i Plus / Insight Installation Manual
1.3 Conventions in this Manual
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 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.
ESD
susceptibility Indicates that an item is susceptible to damage
from electrostatic discharges.

1. Introduction
PaX-i Plus / Insight Installation Manual 3
Never touch or hold the Sensor or Tube Head areas while moving,
installing or operating the equipment.
Do not use the electrical power drill during installation unless it is
allowed to do so.
Do not use the electrical power drill during installation unless it is
allowed to do so.

1. Introduction
4 PaX-i Plus / Insight Installation Manual
Recommended holding area during transportation is as below.
Three installers are required to install the equipment safely.
The Main Power Switch and Emergency Stop Switch are located
under the bottom of the Vertical Frame as below.

1. Introduction
PaX-i Plus / Insight Installation Manual 5
Cautions
It is critical that installers read and understand the installation
instructions fully before installation.
The installer must confirm that the system is installed
according to the instructions provided by this manual and
perform the appropriate procedures therein.
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.
Installation and related work must only be performed by
people authorized by VATECH.
Do not connect any items or equipment to this system which
are not part of the system: IEC60601-1-1 (3rd edition: 2005).
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.
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.
Never touch sensitive areas such as sensors during
installation. These areas are indicated at the applicable stages
during the installation procedures.
Use of wireless phones may interfere with the operation of this
equipment.
Use an ESD (electrostatic sensitive device) wrist band during
installation and connect it to a ground wire.
Touch a ground point to discharge static electricity before
handling PCB boards.

1. Introduction
6 PaX-i Plus / Insight Installation Manual
Installation Site
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.
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.
This equipment should not be installed in the immediate vicinity
of other devices.
Do not install the equipment in an area that is exposed to
strong electromagnetic fields.
Do not install this system in an area where there is the risk of
an explosion.
The electrical installation of this system shall comply with all
local code requirements for electro-medical systems: IEC
60364-7-710:2002.
It is strongly recommended that a UPS be installed at the same
time as the equipment.
The equipment, PC, and all peripheral devices must be well
grounded.
Warnings Regarding X-ray Radiation
Failure to install this equipment in an approved location may be
dangerous to the patient and operator.
Stationary radiation shielding must be installed to protect the
operator from radiation.
The X-ray system may cause injury to the patient if improperly
used. Obey all federal and municipal standards regarding
radiation safety.
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.
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.

1. Introduction
PaX-i Plus / Insight Installation Manual 7
This equipment complies with the followingstandards.
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
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 equipment.
Any equipment not provided by VATECH can be connected
when the following standards are complied with: IEC 60950-1
and IEC 60601-1
The electrical installation shall comply with local code
requirements for electro-medical systems: IEC 60364-7-710:
2002.

1. Introduction
8 PaX-i Plus / Insight Installation Manual
1.4 Marks and Symbols
Symbols Description Location
Dangerous voltage Power board / Inverter board /
Monoblock
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
CSA mark
No.266436 Label
Caution: Federal law restricts
this device to sale by or on the
order of a licensed healthcare
practitioner. Label

1. Introduction
PaX-i Plus / Insight Installation Manual 9
Symbols Description Location
Addresses where the
equipment was manufactured. Label
Indicates that electrical and
electronic equipment must not
be disposed of as unsorted
municipal waste and must be
collected separately.
Label
Warns ESD hazard. MCU board /
Board package
Indicates that this equipment is
classified as a CLASS 1
LASER PRODUCT in
accordance with IEC 60825-1
ED.2 regulations.
Label
Indicates that the user needs to
refer to the Instruction
Manual. Label
Indicates the date of
manufacture. Label
Indicates the manufacturer's
serial number so that the
specific equipment can be
identified. Label

1. Introduction
10 PaX-i Plus / Insight Installation Manual
1.5 Standards and Regulations
Standards
PaX-i Plus / Insight (Model: PCH-30CS) is designed and developed to comply with
the following international standards and regulations:
IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63
CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1-3:09, CAN/CSA-
C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-2-63:15, CAN/CSA-IEC
62366:15
ANSI/AAMI ES60601-1:2005 / (R)2012, ANDA1:2012, A2:2010 / (R)2012
(Consolidated text - edition 3.1)
21 CFR 1020.30, 31, 33
NEMA Standard publication PS 3.1-3.18, 2008
This is Class IIb equipment and obtained CE marking in
April, 2007 for regulations compliance in accordance with
the revised European Union’s MDD (Medical Devices
Directive) 93/42 EEC.
This equipment received the CSA certification mark in
accordance with CAN/CSA C22.2 No.601.1 regulations.
Classifications (IEC 60601-1 6.1)
Degree of protection against water ingress: Ordinary Equipment: IPX0
Degree of protection against electric shock: Class 1 equipment, Type B Applied
Parts: Temple Supports, Chinrests and Bites.