Vatech PAX-I User Manual

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User Manual

Model : PCH-2500 Version : 2.72

• English

Full version

"i" stands for 'innovation', one of the

core values of VATECH, which aims to

expand accessibility of medical solutions

to more people.

PaX-i (PCH-2500) User Manual

Table of Contents

1.1

1.2

1.3

1.4

2.1

2.2

2.3

2.4

3.1

 3.1.1

 3.1.2

General Information ....................................... 08

Notice .................................................................................. 08

Manufacturer's Liability ........................................................ 09

Owner and Operator's Obligations ...................................... 09

Conventions in this Manual ................................................. 10

Warnings and Precautions ............................ 12

General Safety Precautions ................................................. 12

Electricity-related Safety Precautions .................................. 16

Radiation Safety .................................................................. 17

Warnings ............................................................................. 18

PaX-i Imaging System Overview ................... 22

Introduction .......................................................................... 22

System Components.............................................................22

Features ................................................................................22

 3.1.3

 3.1.4

3.2

3.3

 3.3.1

 3.3.2

 3.3.3

 3.3.4

3.4

 3.4.1

 3.4.2

3.5

 3.5.1

The PaX-i Options.................................................................23

Standards and Regulations...................................................23

Imaging System Structure ................................................... 24

General View of the PaX-i ................................................... 27

Laser Beams .........................................................................29

The Exposure Switch ............................................................29

Emergency Stop Button ........................................................30

Components and Positioning Accessories ...........................31

Examination Programs and Exposure Time ........................ 32

PANO Mode ..........................................................................32

CEPH Mode ..........................................................................34

Marks and Symbols ............................................................. 34

Label Locations .....................................................................36

PaX-i (PCH-2500) User Manual

Table of Contents

4.1

4.2

4.3

 4.3.1

 4.3.2

5.1

5.2

 5.2.1

 5.2.2

5.3

6.1

Software Overview ......................................... 40

PC System Requirements (Recommended) ....................... 40

EasyDent ............................................................................. 41

Imaging Software Overview ................................................. 42

PANO Mode ..........................................................................47

CEPH Mode ..........................................................................51

Getting Started ............................................... 54

Turning on the PaX-i ............................................................ 54

Running the Image Viewer – EasyDent ............................... 55

Creating a New Patient Record ............................................55

Retrieving Patient Records ...................................................56

Initiating the Imaging Program ............................................. 57

Acquiring PANO Images ................................ 60

PANO Imaging Program ...................................................... 60

6.2

6.3

 6.3.1

 6.3.2

 6.3.3

 6.3.4

6.4

7.1

7.2

 7.2.1

 7.2.2

 7.2.3

 7.2.5

Setting Exposure Parameters .............................................. 65

Positioning the Patient ......................................................... 68

Pano Standard Mode ............................................................69

TMJ Open Mode ...................................................................73

TMJ Close Mode ...................................................................76

Sinus Mode ...........................................................................77

Initiating X-Ray Exposure .................................................... 80

Acquiring CEPH Images ................................ 86

Setting the Exposure Parameters ........................................ 86

Positioning the Patient ......................................................... 89

Lateral Mode .........................................................................90

Frontal Mode (PA).................................................................92

SMV Mode ............................................................................94

Waters View Mode ................................................................95

7.2.4

CARPUS Mode .....................................................................96

7.3

Initiating X-Ray Exposure .................................................... 98

PaX-i (PCH-2500) User Manual

Table of Contents

9.1

9.2

10.

11.

11.1

11.2

11.3

11.4

Appendices

Troubleshooting ........................................... 102

Cleaning and Maintenance .......................... 104

Cleaning ............................................................................ 104

Maintenance ...................................................................... 105

Disposing of the Unit ................................... 106

Technical Specications ............................. 110

Mechanical Specications ................................................. 110

Technical Specications .................................................... 113

Electrical Specications ..................................................... 117

Environmental Specications ............................................ 120

Recommended X-Ray Exposure Table ............. 120

2.1

2.2

2.3

X-Ray Dose Data ........................................... 122

DAP Table ......................................................................... 122

X-ray Leakage Dose .......................................................... 123

X-Ray Scatter Dose ........................................................... 125

Electromagnetic Compatibility (EMC)

Information ................................................... 126

Acquiring image for the pediatric dental

patient ............................................................ 130

4.1

4.2

4.3

4.4

Age group: classication table ........................................... 130

Positioning the pediatric dental patient .............................. 130

Setting exposure values to the age group ......................... 131

The references pertinent to the potential risks for the pediatric

patients .............................................................................. 131

Abbreviations ............................................... 134

General Information

1.1

1.2

1.3

1.4

Notice .................................................................................. 08

Manufacturer's Liability ........................................................ 09

Owner and Operator's Obligations ...................................... 09

Conventions in this Manual ................................................. 10

PaX-i (PCH-2500) User Manual

1. General Information

 1.1

General Information

Notice

Thank you for purchasing the

PaX-i

The

a panoramic and Cephalometric (optional) imaging capabilities into a single

system.

This manual describes how to operate the

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.

The QR code linked to video le about image capture for the

CEPH Lateral

and

have the QR code reader application program can be used to watch the video.

PaX-i

is an advanced digital dental diagnostic system that incorporates

is provided in the manual. The smartphone and pad which

extra-oral imaging system.

PaX-i

system. It is recommended

PANO Standard

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

VATECH Co., Ltd.

Phone: +82-1588-9510

E-mail: gcs@vatech.co.kr

This document is originally written in English.

The PaX-i is referred to as Equipment in this manual.

Manual Name: PaX-i

Version: 2.72

Publication Date: 2018-05

(PCH-2500) User Manual

PaX-i (PCH-2500) User Manual

1. General Information

 1.2

Manufacturer's Liability

The manufacturers and/or retailers of this equipment assume responsibility for

the safe and normal operation of this product

■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.

only when:

 1.3

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

Cleaning and Maintenance.

Chapter 9:

PaX-i (PCH-2500) User Manual

1. General Information

 1.4

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 the utmost care. Failure to comply with a

WARNING

CAUTION

X-RAY

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.

IMPORTANT

NOTE

SINGLE USE

Indicates a situation or action that could

potentially cause problems to the equipment

and/or its operation.

Emphasizes important information or provide

useful tips and hints.

Indicates a component which must be replaced

for each new patient.

Warnings and Precautions

2.1

2.2

2.3

2.4

General Safety Precautions ................................................. 12

Electricity-related Safety Precautions .................................. 16

Radiation Safety .................................................................. 17

Warnings ............................................................................. 18

PaX-i (PCH-2500) User Manual

2. Warnings and Precautions

 2.1

Warnings and Precautions

WARNING

General Safety Precautions

Operator qualications

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.

Be sure to strictly observe all warnings and safety

instructions included in this manual.

General safety precautions

■Follow the instructions specied 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 to 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 eld 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.

PaX-i (PCH-2500) User Manual

2. Warnings and Precautions

CAUTION

■Observe all local re regulations. Always keep a re 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.

■Always leave a sufcient amount of 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.

■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, including the Touchscreen, can be

cleaned using a soft cloth dampened with a mild cleaning solution.

PaX-i (PCH-2500) User Manual

2. Warnings and Precautions

■Disinfect the components (bite block, temple supports etc.) of the equipment

■New hygiene cover must be provided for each new patient to prevent the

IMPORTANT

Condensation

■Extreme fluctuations in temperature may cause condensation to develop

that come into contact with the patient or the operator after each exposure.

transmission of communicable disease.

Do not use aerosol or spray cleaning agents directly on the

surface of the equipment.

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. 20.2 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 ℉).

■ If the fan (optional) is installed, it operates automatically when the

temperature surrounding the tube head reaches the pre-dened level: 40 ℃

(104 ℉). The setpoint temperature is congurable.

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.

PaX-i (PCH-2500) User Manual

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 ℉ to 95 ℉) for the safe operation. Image quality may deteriorate if the

equipment is operated outside of this range.

■ Always allow the equipment sufcient time to warm up (while switched on) if

it has been exposed to temperatures of below 10 °C (50 ℉).

■ Only perform X-rays of patients if the system is in full working order.

■ Always ensure that equipment movement is not obstructed by the patient’s

clothing, a medical device (such as a wheelchair), or the patient themselves.

■ Do not leave the patient unattended around the equipment.

■ Remove all radio-controlled devices, mobile phones, etc. from the X-Ray

room prior to image acquisition as these objects may cause the equipment

to malfunction.

Modifying the equipment

■Modifying the equipment in any way which may 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.

PaX-i (PCH-2500) User Manual

2. Warnings and Precautions

 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.

■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

■The PaX-i X-Ray unit complies with IEC standard 60601-1-2.

■Medical electrical equipment is subject to special EMC preventive

measures. It must be installed and operated as specied in the

Requirements

■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 ofces or hospital environments must be prohibited.

document.

Installation

PaX-i (PCH-2500) User Manual

2. Warnings and Precautions

 2.3

For more details, refer to the document

Information.

Electromagnetic Compatibility

Electro-Static Discharge

Connector pins or sockets bearing ESD warning labels must not be touched or

interconnected without observing ESD protective measures.

Radiation Safety

Since rules and regulations concerning radiation safety

differ between countries, it is the responsibility of the

WARNING

■The operator must remain outside a shielded room during X-Ray exposure

in order to protect himself/herself from radiation.

owner and/or operator of this equipment to comply with

all applicable rules and regulations concerning radiation

safety and protection in their area.

■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.

■The operator must immediately stop imaging if the equipment malfunctions.

As a manufacturer of radiology equipment that conforms

to stringent protection standards around the world, we

WARNING

guarantee the maximum degree of protection against

radiation hazards for our equipment.

PaX-i (PCH-2500) User Manual

2. Warnings and Precautions

 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.

WARNING

It is important to read this user manual carefully and

strictly abide by all warnings and cautions stated within it.

- PaX-i 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

WARNING

immediately power off the Dental X-ray system.

- PaX-i 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.

Lasers

■The system incorporates Class 1 laser products. The light localizers used

■For maximum safety, advise the patient not to look directly at the laser

■While adjusting the patient, ensure that the laser beam is not directed at the

■Equipment to liquids may cause an electrical shock or otherwise damage

■Do not use spray cleaners on this equipment, as this could cause a re.

in this product are intended for correct patient positioning and must not be

used for any other purpose.

beam.

patient’s eyes.

the system.

PaX-i (PCH-2500) User Manual

2. Warnings and Precautions

CAUTION

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.

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 re.

During Operation

■Never use this equipment in an environment that is susceptible to explosion.

■Do not place ammable materials near this equipment.

■Do not operate the PC or Touchscreen 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

located on top of the handle frame 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.

In case of an electrical re

■Use only re extinguishers designed for electrical res to extinguish res 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 re.

Installation

■In order to avoid improperly balanced equipment, install the device on a at

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.

PaX-i Imaging System Overview