Vatech EzRay Air VEX-P300 User manual

User Manual
Model : VEX-P300
Version : 1.48
Full Version
English
Postal Code: 18449
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea
www.vatech.com
User manual

Notice
EzRay Air Portable (Model: VEX-P300) User Manual v
Notice
The EzRay Air Portable (Model: VEX-P300) is a portable dental X-ray system.
This manual contains descriptions, operational instructions, imaging procedures for the
EzRay Air Portable (Model: VEX-P300) dental X-ray system. It is recommended that
you thoroughly familiarize yourself with this manual to make the most effective use of
this device. Observe all cautions, safety messages, and warnings that appear in this
manual.
Always keep this manual with the device and review the operating procedures and
safety instructions if needed.
The illustrations/photos of the device in this manual are only for illustration purposes.
The actual device may differ.
Due to continuous technological improvements, the manual may not contain the most
updated information. For further information not covered in this manual, please contact
us at:
VATECH Co., Ltd.
Phone: [phone]
E-mail: [e-mail]
This document is originally written in English.
The EzRay Air Portable is referred to as a device in this manual.
Manual Name: EzRay Air Portable (Model: VEX-P300) User Manual
Document number: VDH-UM-067
Version: 1.48
Publication Date: 2020-09
The EzRay Air Portable (Model: VEX-P300) unit is intended
to be used by a certified professional, exclusively for
dental radiography.

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vi EzRay Air Portable (Model: VEX-P300) User Manual
This page is intentionally left blank.

Notice
EzRay Air Portable (Model: VEX-P300) User Manual vii
Table of Contents
Notice v
Table of Contents vii
1. General and Regulatory Information 1
1.1 Manufacturer's Liability ....................................................................................1
1.2 Owner and Operator's Obligations...................................................................1
1.3 Conventions Used in this Manual.....................................................................2
1.4 Marks and Symbols.........................................................................................3
1.5 Standards and Regulations..............................................................................6
2. Safety Instructions 7
2.1 General Safety Guidelines...............................................................................7
2.2 Warnings and Safety Instructions.....................................................................8
3. System Overview 11
3.1 Indications for Use......................................................................................... 11
3.2 Principles of Operation...................................................................................11
3.3 Intended User Profile..................................................................................... 11
3.4 Components..................................................................................................12
3.5 Features ........................................................................................................13
3.6 General View of the Device............................................................................14
4. Operation 19
4.1 Power On/Off.................................................................................................19
4.2 Enter Password .............................................................................................20
4.3 Operation Mode.............................................................................................21
4.4 Positioning.....................................................................................................23
4.5 Exposure .......................................................................................................32
4.6 Using the Battery...........................................................................................34
5. Service Mode 43
5.1 Overview .......................................................................................................43
5.2 Changing System Parameters .......................................................................44

Notice
viii EzRay Air Portable (Model: VEX-P300) User Manual
5.3 Service Mode Menu.......................................................................................47
6. Troubleshooting 59
7. Cleaning and Maintenance 63
7.1 Cleaning ........................................................................................................63
7.2 Maintenance..................................................................................................64
8. Disposing of the Unit 67
9. Device Specifications 69
9.1 Mechanical Specifications..............................................................................69
9.2 Technical Specifications.................................................................................70
9.3 Electrical Specifications .................................................................................74
9.4 Environmental Specifications.........................................................................74
10. Appendix 75
10.1 Combining the Holder and the devices using a tripod.....................................75
10.2 Using the Rotating Rectangular Cover...........................................................77
10.3 Tables of Exposure Times (Default)................................................................79
10.4 X-ray Dose Data ............................................................................................83
10.5 Electromagnetic Compatibility (EMC) Information ..........................................92
10.6 Abbreviations.................................................................................................95

1. General and Regulatory Information
EzRay Air Portable (Model: VEX-P300) User Manual 1
ENGLISH
1. General and Regulatory Information
1.1 Manufacturer's Liability
The manufacturers and retailers of this device assume responsibility for the safe and
normal operation only when:
Always using genuine VATECH approved devices and parts.
Performing all maintenance and repairs at a VATECH authorized distributor.
Using this device properly following the user manual.
The device damage or malfunction is not the result of an error on the owner or
operator.
Disclaimer:
EzRay Air Portable (Model: VEX-P300) is sold with the
understanding that the user assumes sole responsibility for radiation
safety (as well as any state, provincial, or local regulatory compliance)
and that VATECH, its agents or representatives, do not accept
responsibility for:
1) any injury or danger to personnel from X-ray exposure,
2) image over/underexposure due to poor operating techniques or
procedures,
3) device which has been damaged, modified, or tampered with in
any way.
1.2 Owner and Operator's Obligations
This device owner must perform constancy tests at regular intervals to ensure
patient and operator safety. Local X-ray safety regulations must perform these
tests.
This device owner must perform regular inspection and maintenance of the
mechanical and electrical components to ensure safe and consistent operation
(IEC 60601-1).
This device owner must ensure inspection and cleaning work is performed by the
maintenance schedule outlined in Chapter 7 Cleaning and Maintenance.
DO NOT operate this device until reading this manual and
reviewed the related materials.

1. General and Regulatory Information
2 EzRay Air Portable (Model: VEX-P300) User Manual
1.3 Conventions Used in this Manual
The following symbols are used throughout this manual. Make sure that fully
understand each symbol and follow the instructions which accompany it.
Please observe all warnings and safety information included in this document to
prevent personal injury and damage to the device.
Indicates a potentially hazardous situation and improper
handling may result in:
•Serious bodily injury (User or veterinary patient)
•Substantial property damage
Indicates a potentially hazardous situation and improper
handling may result in:
•Light injury
•Property damage
Indicates a potentially harmful situation, and improper
handling may result in:
•Property damage
Indicates a usage and other valuable information.
Indicates a possible danger from radiation exposure.

1. General and Regulatory Information
EzRay Air Portable (Model: VEX-P300) User Manual 3
ENGLISH
1.4 Marks and Symbols
The following table describes the purpose and location of safety symbols and other
valuable information provided on the device.
Mark/Symbol Description Location
Alternate current Battery Charger Label
Direct current Main Label
Attention:
Consult accompanying documents Main Label
Dangerous voltage Powerboard, X-ray Generator,
Generator Label
Off (power: disconnect from the
main switch)
Battery bay
access door
(outside)
On (power: connect to the main
switch)
Battery bay
access door
(outside)
IEC60601-
1
Degree of Protection from Electric
Shock TYPE B Equipment Main Label
Radiation hazard Generator Label
Authorized European
Representative address Main Label
The CE symbol indicates that this
device complies with the European
Directive for Medical Devices
93/42/EEC as amended by
2007/47/EC as a class IIb device.
Main Label
UL mark No. E476672 Main Label

1. General and Regulatory Information
4 EzRay Air Portable (Model: VEX-P300) User Manual
Caution: Federal law restricts this
device to sale by or about a
licensed healthcare practitioner. Main Label
Manufacturer’s name and address Main Label,
Generator Label
Date of manufacture Main Label,
Generator Label
This symbol indicates that electrical
and electronic devices must not be
disposed of as unsorted municipal
waste and must be collected
separately.
Main Label
ESD susceptibility symbols indicate
that an item is susceptible to
damage from electrostatic
discharges.
Board
package
Refer to the User Manual. Main Label
Using a Torx wrench, unscrew the
battery bay access door. Main Label
Lift the door after the removal of the
screw. Main Label
This symbol indicates the direction
of cover attachment/detachment. Cone’s upper
part

1. General and Regulatory Information
EzRay Air Portable (Model: VEX-P300) User Manual 5
ENGLISH
1.4.1 Label Locations
1. Generator Label
2. Main Label
3. UDI Label
The labels' design and contents may be different in some
countries based on local regulations and standards.
1
2
3

1. General and Regulatory Information
6 EzRay Air Portable (Model: VEX-P300) User Manual
1.5 Standards and Regulations
Standards:
The device is designed and manufactured to meet the following standards:
MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012),
CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-3 (2008), IEC 60601-2-
65(2012)
ISO 13485
21 CFR 1020.30 & 1020.31
This is Class IIb equipment and obtained CE marking in
April 2007 for regulation compliance by the revised
European Union’s MDD (Medical Devices Directive)
93/42 EEC.
This equipment received the UL certification mark in
accordance with ANSI/AAMI, CAN/CSA-C22.2 No.
60601-1 regulations.
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment (IPX0)
Protection against electric shock: Class II equipment,
Type B Applied Parts: Backscatter Shield, Round Cover, Rectangular Cover, Rotating
Rectangular Cover

2. Safety Instructions
EzRay Air Portable (Model: VEX-P300) User Manual 7
ENGLISH
2. Safety Instructions
2.1 General Safety Guidelines
This device is designed and manufactured to ensure the
most significant safety of operation. Operate and maintain
it in strict compliance with the safety precautions and
operating instructions contained in this manual.
Only a legally qualified person, i.e., a radiographer,
diagnostic radiographers, medical radiation technologists,
or healthcare professionals who specialize in imaging
medical for the diagnosis and treatment of pathology, can
operate this equipment in a controlled environment.
Observe all local fire regulations.Always keep a fire
extinguisher near the device.
The device must be installed, maintained, and serviced by
qualified service personnel according to the procedures
and preventive maintenance schedules. Users can perform
an only battery replacement.
Ensure that the on/off switch is set to off when the device is
not in use.
Always disconnect the power supply before cleaning the
device.
DO NOT keep the device or its parts in a humid place or a
liquid substance.
Avoid placing the device near chemical storage and gas-
filled storage facilities.
The backscatter shield protects users from backscatter
radiation that they might be exposed to during X-ray
exposure. Operating the device with the backscatter shield
allows the users to be exposed to less radiation than when
operating without. For details on the scattering data of the
device configured both with and without the backscatter
shield, please review 10.4.3 Scattered Dose.
Wireless communication equipment is used no closer than
30 cm (12 inches) to any part of the EzRay Air
Portable(Model: VEX-P300), including cables specified by
VATECH.
This device is shipped with the backscatter shield attached
(firmly fixed), so users can not replace the backscatter shield.
If it is damaged or defective, contact your Service
Representative for replacement.
Mode of operation: Non-continuous operation with cyclic
loading—This device needs a rest time of at least 60 times
the exposure time before starting the next exposure.

2. Safety Instructions
8 EzRay Air Portable (Model: VEX-P300) User Manual
2.2 Warnings and Safety Instructions
This X-ray unit may be dangerous to patients and
operators unless safe exposure factors, operating
instructions, and maintenance schedules are observed.
It is essential to read this user manual carefully and strictly
abide by all warnings and cautions stated.
To avoid the risk of electric shock, this device must only be
connected to the supply main with protective earth.
Since rules and regulations concerning radiation safety
differ between countries, it is the responsibility of the owner
and operator of this device to comply with all applicable
rules and regulations concerning radiation safety and
protection in their area.
DO NOT open or remove the cover panels on this device.
Never expose this device to liquids, mists, or sprays.
Exposing this device to liquids may cause an electrical
shock or otherwise damage the system.
DO NOT use spray cleaners on this device, as this could
cause a fire.
Never use this device in an environment that is susceptible
to explosion.
DO NOT place flammable materials near this device.
Never touch the patient while also touching the SIP/SOP
connectors.
The medical electrical device is subject to special EMC
preventive measures. For more details, refer to 10.5
Electromagnetic Compatibility (EMC) Information.
Patients and operators are encouraged to wear leaded
protective lead-lined aprons unless other Radiation
Protection Protocols are applied locally.
Children and pregnant women must consult with a doctor
before X-ray exposure.
Never try to modify this device, including the wires or
cables. Modifying this device may damage it beyond repair.
Serious dangers may occur from electromagnetic
interference (i.e., noise) between other devices in the area
during specific examinations or medical treatment.
Battery chargers must be in an accessible area where they
can be easily unplugged from the power source.

2. Safety Instructions
EzRay Air Portable (Model: VEX-P300) User Manual 9
ENGLISH
Battery Use
Make sure to charge the battery in the external
environment from the patient.
Make sure to use the battery only provided or approved by
VATECH. If non-standard or damaged batteries are used,
there is a risk of fire and explosion.
Make sure to use the battery charger only provided or
approved by VATECH. Using an unauthorized charger may
result in battery damage.
DO NOT expose batteries to heat or fire. Avoid storage in
direct sunlight.
DO NOT short-circuit, crush, puncture, mutilate, or
disassemble the battery.
DO NOT store batteries haphazardly in a box or drawer
where they may short-circuit each other or be short-
circuited by other metal objects.
Observe the plus (+) and minus (-) marks on the battery
and device and ensure correct use.
DO NOT subject batteries to mechanical shock.
In a cell leaking event, do not allow the liquid to meet the
skin or eyes. If the contact has been made, wash the
affected area with copious amounts of water, and seek
medical advice.
Keep the battery away from children and pets.
DO NOT make the battery wet or let it be in the water.
Keep batteries clean and dry.
Seek medical advice immediately if a battery has been
swallowed.
Make sure to turn off the device before replacing the
battery.
DO NOT remove a battery from its original packaging until
required for use.
DO NOT dispose of batteries with ordinary trash. Turn in
discharged batteries to local supply or discard or recycle
batteries according to your local government regulations.
DO NOT leave a battery on a prolonged charge when not
in use.
If the device has not been used for long periods, it is
recommended to charge the battery before use.
After extended periods of storage, it may be necessary to
charge and discharge the cells or batteries several times to
obtain maximum performance.

2. Safety Instructions
10 EzRay Air Portable (Model: VEX-P300) User Manual
If the device not in use has been turned on for long periods,
the battery may be fully discharged.
- Depending upon the battery discharge status, it takes
about 1 day for charging the battery. If the device is not
turned on after charging the battery for about 1 day, it
indicates that the battery has been fully discharged.
Contact your Service Representative for battery
replacement.
- DO NOT charge a fully discharged battery, as this may
cause fire or explosion. Be sure to replace the battery
(provided by VATECH).
Users can replace batteries.
When charging the battery, the exposure function is locked.
Be sure to turn off the device when not in use. This helps
to ensure the life of the battery.
Be sure to charge the battery frequently. This helps to
ensure the life of the battery.
Radiation Safety
When using the device, it is recommended that all users
comply with the following radiation safety guidelines for the
users and the patients' safety.
All users and patients should wear a protective device,
such as a lead apron, thyroid collar, etc.
This device should be operated in an area that is more than
6 feet away from other personnel, such as assistants or
other patients. If they should stay closer than 6 feet, it is
recommended that they wear a lead apron, thyroid collar,
or stay behind a lead shield.
Pregnant women should not be exposed to X-rays unless it
is strictly necessary.
All users should comply with the Radiation Protection
Policies established by the government.
When selecting a Position Indicating Device, it should be
considered if the PID can be used with the backscatter
shield attached at the cone's outer end for most operator
protection.

3. System Overview
EzRay Air Portable (Model: VEX-P300) User Manual 11
ENGLISH
3. System Overview
The device, a portable dental X-ray system, operates on 21.6 Vdc supplied by a
rechargeable Li-ion battery pack. The portable X-ray system is an X-ray generating
device designed for dental examination (teeth and jaw). The portable X-ray system is
composed of an X-ray generating part with an X-ray tube including a device controller,
a power controller, a user interface, a beam limiting part, a backscatter shield, and an
optional Remote Exposure Switch. The device is designed to diagnose teeth and jaw
through X-ray exposure using intra-oral image receptors.
3.1 Indications for Use
EzRay Air Portable (Model: VEX-P300) is an extraoral diagnostic dental X-ray source
to produce X-ray images using intraoral image receptors. It is indicated for use by a
dentist or a dental technician for both adult and pediatric patients.
3.2 Principles of Operation
X-rays are emitted when a high voltage is supplied to the X-ray tube assembly, which
frees electrons from the cathode. They hit anode to produce X-rays. The device
acquires images by emitting X-rays continuously on the human tooth.
3.3 Intended User Profile
Considerations Requirement Description
Education A licensed dentist or dental hygiene, radiologist, and graduates of relevant bachelor’s degree (national
qualifications)
Knowledge
The operator must have understood:
treatment and diagnosis of dental disease
terms and guidance of diagnostic medical radiation devices
device connection, installation, and operating conditions.
Language
understanding
The operator must have understood:
the English or Korean manuals (or other languages
provided).
Experience
The operator must have understood:
objectives and effects of treatment and diagnosis of dental
disease using diagnostic medical radiation devices
normal operation of diagnostic medical radiation devices
the contents of the user manual.

3. System Overview
12 EzRay Air Portable (Model: VEX-P300) User Manual
3.4 Components
No. Item Standard Option Qty.
1 Main Body (included the Backscatter Shield
and the Round Cover) ●1
2 Hand/Neck Strap ●1
3 Rectangular Cover (4x3) ●1
4 power cord ●1
5 Battery Charger ●1
6 User Manual ●1
7 Cradle ●1
8 Rectangular Cover (2x3) ●1
9 Rotating Rectangular Cover (4x3) ●1
10 Rotating Rectangular Cover (2x3) ●1
11 Remote Exposure Switch ●* 1
12 Base Holder ●* 1
13 Tripod ●* 1
**Read the notice on the next page for the options with the symbol (*)