Vatech A9 User manual

Notice
2 vatech A9 (Model name: PHT-30CSS) User Manual

Notice
vatech A9 (Model name: PHT-30CSS) User Manual 3
English
Notice
Thank you for purchasing the vatech A9 (Model name: PHT-30CSS) extra-oral
imaging system.
vatech A9 (Model name: PHT-30CSS) is one of the manufacturer’s product series for
aiding dental professionals in providing excellent care in a safe environment that
promotes healing.
vatech A9 (Model name: PHT-30CSS) is an advanced digital diagnostic system that
incorporates PANO, CEPH (Optional), CBCT imaging capabilities into a single system.
This manual describes how to operate the vatech A9 (Model name: PHT-30CSS)
system. It is recommended that you thoroughly familiarize yourself with this manual to
make the most effective use of this equipment.
Observe all cautions, safety messages, and warnings 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: [email protected]
This document is originally written in English.
vatech A9 (Model name: PHT-30CSS) is referred to as “equipment” in this manual.
Manual Name: vatech A9 (Model name: PHT-30CSS) User Manual
Version: 1.05
Publication Date: 2021-10
Document Number: VDH-UM-098

Notice
4 vatech A9 (Model name: PHT-30CSS) User Manual
Left blank intentionally

Table of Contents
vatech A9 (Model name: PHT-30CSS) User Manual 5
English
Table of Contents
Notice 3
1. Introduction 9
1.1 Overview ......................................................................................................... 9
1.2 Indications for Use ................................................................................................. 9
1.3 Intended Purposes ............................................................................................... 10
1.4 Intended User Profiles ..........................................................................................11
2. General Information 13
2.1 Manufacturer's Liability ....................................................................................... 13
2.2 Owner and Operator's Obligations ..................................................................... 13
2.3 Conventions in this Manual................................................................................. 14
2.4 Marks and Symbols.............................................................................................. 15
3. Warnings and Precautions 19
3.1 General Safety Guidelines ................................................................................... 19
3.2 Electricity-related Safety Precautions ................................................................ 23
3.3 Radiation Safety ................................................................................................... 25
3.4 Warnings ....................................................................................................... 26
4. Imaging System Overview 29
4.1 System Components............................................................................................ 29
4.2 Features ....................................................................................................... 29
4.3 Imaging System Options ..................................................................................... 29
4.4 Standards and Regulations ................................................................................. 30
4.5 Operating Principles ............................................................................................ 30
4.6 Imaging System Configuration ........................................................................... 31
4.7 Equipment Overview ............................................................................................ 32

Table of Contents
6 vatech A9 (Model name: PHT-30CSS) User Manual
5. Imaging Software Overview 39
5.1 PC Specifications (Recommended) .................................................................... 39
5.2 EzDent-i ....................................................................................................... 40
5.3 Console Software.................................................................................................. 41
6. Getting Started 45
6.1 Turning on the Equipment ................................................................................... 45
6.2 Running the Image Viewer (EzDent-i) ................................................................. 46
6.3 Initiating the Console Software ........................................................................... 48
7. Acquiring PANO Images 49
7.1 PANO Imaging Program Overview ...................................................................... 49
7.2 Configuring Exposure Parameters...................................................................... 56
7.3 Patient Positioning ............................................................................................... 60
7.4 X-ray Exposure...................................................................................................... 75
7.5 Finishing the Scan ................................................................................................ 76
7.6 Checking the Captured Images ........................................................................... 76
8. Acquiring CEPH Images (Optional) 77
8.1 CEPH Imaging Program Overview ...................................................................... 77
8.2 Configuring Exposure Parameters...................................................................... 80
8.3 Patient Positioning ............................................................................................... 83
8.4 X-ray Exposure...................................................................................................... 95
8.5 Finishing the Scan ................................................................................................ 95
8.6 Checking the Captured Images ........................................................................... 96

Table of Contents
vatech A9 (Model name: PHT-30CSS) User Manual 7
English
9. Acquiring CBCT Images 97
9.1 CBCT Imaging Program Overview ...................................................................... 97
9.2 Configuring Exposure Parameters ..................................................................... 98
9.3 Configuring the third molar teeth exposure parameters (optional)............... 102
9.4 Patient Positioning ............................................................................................. 105
9.5 X-ray Exposure ....................................................................................................114
9.6 Finishing the Scan...............................................................................................115
9.7 Checking the Captured Images..........................................................................115
9.8 Image Comparison according to Patient Position – Incorrect Posture .........116
10. Troubleshooting 119
10.1 Troubleshooting ................................................................................................119
10.2 Error Codes ..................................................................................................... 120
11. Cleaning and Disinfection 125
11.1 Cleaning ..................................................................................................... 125
11.2 Disinfection ..................................................................................................... 126
12. Maintenance 127
12.1 Regular Maintenance ....................................................................................... 127
12.2 Maintenance Task Checklist............................................................................ 128
12.3 QA Test ..................................................................................................... 129
12.4 QA Test Procedure ........................................................................................... 131
13. Disposing of the Equipment 141
14. Technical Specifications 143
14.1 Mechanical Specifications............................................................................... 143
14.2 Technical Specifications.................................................................................. 147
14.3 Electrical Specifications .................................................................................. 152
14.4 Environmental Specifications ......................................................................... 153

Table of Contents
8 vatech A9 (Model name: PHT-30CSS) User Manual
15. Appendices 155
15.1 Recommended X-ray Exposure Tables........................................................... 155
15.2 X-ray Dose Data ................................................................................................ 162
15.3 Electromagnetic Compatibility (EMC) Information ........................................ 175
15.4 Acquiring Images for Pediatric Dental Patients............................................. 178
15.5 Degree of cervical ghost occurrence according to Forward head posture
..................................................................................................... 189
15.6 Abbreviations .................................................................................................... 192

1. Introduction
vatech A9 (Model name: PHT-30CSS) User Manual 9
English
1. Introduction
1.1 Overview
vatech A9 (Model name: PHT-30CSS) is an advanced 3-in-1 digital X-ray imaging
system that incorporates PANO, CEPH (Optional), and CBCT scan imaging
capabilities into a single system.
vatech A9 (Model name: PHT-30CSS), a digital radiography imaging system,
exposure an X-ray to a sitting patient and acquires and processes diagnostic images
for dentists.
Designed explicitly for dental radiography, vatech A9 (Model name: PHT-30CSS) is a
complete digital X-ray system equipped with imaging viewers, an 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 the head, neck, oral surgery,
implant, and orthodontic treatment.
1.2 Indications for Use
vatech A9 (Model name: PHT-30CSS) is intended to produce panoramic, cone beam
computed tomography or cephalometric digital x-ray images. It provides diagnostic
details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The
system also utilizes carpal images for orthodontic treatment. The equipment is to be
operated by healthcare professionals.

1. Introduction
10 vatech A9 (Model name: PHT-30CSS) User Manual
1.3 Intended Purposes
• Determination of the extent of lesions, tumors, cysts, etc., which cannot be fully
visualized on plain films.
• Identifying the relationship of the inferior dental canal to a tooth/lesion that is to be
removed.
• Visualization of 3D anatomy of the alveolar clefts.
• Diagnosis of un-erupted teeth, third molar teeth, and odontomas.
• Diagnosis of third molar teeth is only available in some Asian countries and
Mexico.
• Diagnosis of root resorption of teeth.
• Assessment of cleft palate.
• Assessment of complex root canal anatomy.
• Diagnosis of periapical pathology.
• Diagnosis of vertical root fracture.
• Assessment of fractures on maxilla, mandible, and fractures of teeth where plain
film imaging is equivocal.
• Reconstruction of position, malformations, and fractures of maxilla & mandible
bones and nasal bone as 3D pictures for operational planning and patient
education.

1. Introduction
vatech A9 (Model name: PHT-30CSS) User Manual 11
English
1.4 Intended User Profiles
Considerations Requirement Description
Education
Licensed dentists or dental hygienists, radiologists, and
graduates of relevant bachelor’s degree (national
qualifications)
Knowledge
Understanding the treatment and diagnosis of dental
disease
Understanding the terms and guidance of hardware and
software of diagnostic medical radiation equipment and
recognizing equipment connection, installation, operating
conditions
Language
understanding
Understanding how to use manuals (English/Korean) or
Understanding other languages provided
Experience
Understanding the objectives and effects of the diagnosis
and treatment of dental disease using diagnostic medical
radiation equipment
Understanding of the normal operation of diagnostic
medical radiation equipment
Understanding the contents of the User Manual
Qualified personnel should use X-ray CBCT (dentists, dental
hygienists, or radiologists only).

1. Introduction
12 vatech A9 (Model name: PHT-30CSS) User Manual
Left blank intentionally

2. General Information
vatech A9 (Model name: PHT-30CSS) User Manual 13
English
2. General Information
2.1 Manufacturer's Liability
The manufacturers and retailers of this X-ray equipment assume responsibility for the
safe and healthy operation of this product only when:
A VATECH-authorized technician has installed the equipment.
The equipment has been installed by all the cautions and conditions required for
installation.
The good VATECH approved equipment and components have always been
used.
A VATECH-authorized agent has performed all maintenance and repairs.
The User Manual has typically used the equipment.
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 to
ensure patient and operator safety. Local X-ray safety regulations must perform
these tests.
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(Disinfection)
work is performed by the maintenance schedule outlined in 11. Cleaning and
Disinfection and 12. Maintenance.

2. General Information
14 vatech A9 (Model name: PHT-30CSS) 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 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 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 its operation.
NOTICE Emphasizes essential information or
provides useful tips and hints.
RADIATION Indicates a possible danger from radiation
exposure.
SINGLE USE Indicates a component that must be
replaced for each new patient.
ESD
susceptibility
Indicates that an item is susceptible to
damage from electrostatic discharges.

2. General Information
vatech A9 (Model name: PHT-30CSS) User Manual 15
English
2.4 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
This indicates Type B Applied Equipment
(IEC 60601-1: Degree of protection against
leakage current and electric shock: Class 1
equipment)
Label
This indicates radiation hazard Label
This 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
This indicates UL mark No. E476672 Label
Caution: Federal law restricts this equipment
to sale by or on the order of a licensed
healthcare practitioner.
Label
This indicates addresses where the
equipment was manufactured. Label
This indicates that electrical and electronic
equipment must not be disposed of as
unsorted municipal waste and must be
collected separately.
Label

2. General Information
16 vatech A9 (Model name: PHT-30CSS) User Manual
Description Location
This indicates warns ESD hazard. MCU board
/Board package
This indicates that this equipment is
classified as a CLASS 1 LASER PRODUCT
by IEC 60825-1 ED. 2 regulations.
Label
This indicates that the user needs to refer to
the User Manual. Label
This indicates the date of manufacture. Label
This indicates the manufacturer's serial
number so that the specific equipment can
be identified.
Label

2. General Information
vatech A9 (Model name: PHT-30CSS) User Manual 17
English
2.4.1 Label Locations
The label is attached on the right side of the equipment, and it consists of 5 parts as
below.
No. Item
1 Main Label
2 CAUTION Label
- X-ray / Attention: X-ray on when equipment in operation.
3 X-RAY GENERATOR Label
: 1.0 kW Generator
4 CLASS 1 LASER PRODUCT Label
5 Manufacturer Label
: The date of manufacture / Serial Number of the equipment

2. General Information
18 vatech A9 (Model name: PHT-30CSS) User Manual
Left blank intentionally

3. Warnings and Precautions
vatech A9 (Model name: PHT-30CSS) User Manual 19
English
3. Warnings and Precautions
Be sure to 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 trained in its operation.
To operate this equipment, the operator must:
-Read and understood the User Manual.
-Be familiar with the fundamental structure and functions of this equipment.
-Be able to recognize the intermittent 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 always maintain vocal/visual contact with the patient during
imaging.
Do not open or remove the cover panels on this equipment. Always have a
trained and authorized service technician to conduct 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.
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.

3. Warnings and Precautions
20 vatech A9 (Model name: PHT-30CSS) User Manual
Ensure that this equipment is kept away from water, moisture, or foreign
substances always.
If this product is exposed to water, moisture, or a foreign substance, immediately
turn off the main power of the equipment and contact your VATECH technical
support representative.
If there are signs of oil leakage, immediately cease all operations of this
equipment and contact your VATECH technical support representative.
External equipment intended for connection to signal input, signal output, or other
connectors, shall comply with relevant IEC Standard (e.g., IEC 60950 for IT
equipment and IEC 60601-1 series for medical electrical equipment).
Also, all such combination-system-shall comply with the standard IEC 60601-1,
and IEC 60601-1-1 harmonized national standard or the combination. If, in doubt,
contact a qualified technician or your local representative.
Any person or organization that installs an external door interlock switch is
responsible for ensuring that it has a radiation indicator or equivalent alarm
system to show the state of the current.
Ventilation
Do not close the equipment’s ventilation slots in any case. The obstruction of
ventilation could result in the equipment overheating due to a lack of air
circulation.
Do not spray any liquid or disinfectant on this equipment. The penetration of these
substances may damage the electrical and mechanical components inside. Use a
soft cloth to disinfect the ventilation slots.
Always leave enough space around the PC to allow for proper ventilation.
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 movable patient support components (the Bite, the Chinrest, and the Ear
Rods) can be cleaned using a non-alcohol based, non-corrosive cleaning solution
Clean the Support Handles by using a non-alcohol-based, non-corrosive cleaning
solution before taking photos of the next patient.
Other surfaces of the equipment, including the Control Panel, can be cleaned
using a soft cloth dampened with a mild cleaning solution.