Vatech EzRay Air VEX-P300 User manual

User Manual
Model : VEX-P300
Version : 1.30
For the United Kingdom region
English
Postal Code: 18449
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea
www.vatech.co.kr
User manual

Notice
EzRay Air (Model: VEX-P300) User Manual v
Notice
The VEX-P300 is a portable dental X-ray system.
This manual contains descriptions, operational instructions, imaging procedures for the
VEX-P300 dental X-ray system. It is recommended that thoroughly familiarize yourself
with this manual in order to make the most effective use of this equipment. Observe all
cautions, safety messages and warnings that appear in this manual.
Keep this manual with the equipment at all times and review the operating procedures
and safety instructions if needed.
The illustrations/photos of the equipment in this manual are only for illustration
purposes. The actual equipment 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: [email protected]
This document is originally written in English.
The VEX-P300 is referred to as Equipment in this manual.
Manual Name: EzRay Air (Model: VEX-P300) User Manual
Document number: VDH-UM-067
Version: 1.30
Publication Date: 2018-03

Notice
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Table of Contents
EzRay Air (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 .............................................................. 7
2. Safety Instructions ..............................................................................9
2.1 General Safety Guidelines ................................................................ 9
2.2 Warnings and Safety Instructions .................................................... 10
3. System Overview...............................................................................13
3.1 Indications for Use ......................................................................... 13
3.2 Principles of Operation ................................................................... 13
3.3 Intended User Profile ..................................................................... 13
3.4 Components.................................................................................. 14
3.5 Features........................................................................................ 14
3.6 General View of the Equipment....................................................... 15
4. Operation...........................................................................................19
4.1 Power On/Off................................................................................. 19
4.2 Operation Mode............................................................................. 21
4.3 Positioning .................................................................................... 23
4.4 Exposure....................................................................................... 35
4.5 Using the Battery ........................................................................... 37
5. Service Mode .....................................................................................45
5.1 Overview....................................................................................... 45
5.2 Changing System Parameters ........................................................ 46
5.3 Service Mode Menu ....................................................................... 49
6. Troubleshooting ................................................................................60
7. Cleaning and Maintenance ................................................................62
7.1 Cleaning........................................................................................ 62
7.2 Maintenance.................................................................................. 63
8. Disposing of the Unit .........................................................................66
9. Equipment Specifications ..................................................................68

Table of Contents
viii EzRay Air (Model: VEX-P300) User Manual
9.1 Mechanical Specifications .............................................................. 68
9.2 Technical Specifications ................................................................. 69
9.3 Electrical Specifications.................................................................. 74
9.4 Environmental Specifications .......................................................... 74
10. Appendix ........................................................................................... 76
10.1 Tables of Exposure Times (Default)................................................. 76
10.2 X-ray Dose Data ............................................................................ 77
10.3 Electromagnetic Compatibility (EMC) Information............................. 87
10.4 Abbreviations ................................................................................ 91

1. General and Regulatory Information
EzRay Air (Model: VEX-P300) User Manual 1
ENGLISH
1. General and Regulatory Information
1.1 Manufacturer's Liability
The manufacturers and/or retailers of this equipment assume responsibility for the safe
and normal operation of this equipment only when:
▪Always use genuine VATECH approved equipment and parts.
▪Perform all maintenance and repairs at a VATECH authorized distributor.
▪Using this equipment properly according to the user manual.
▪The equipment damage or malfunction is not the result of an error on the part of
the owner or operator.
Disclaimer:
EzRay Air 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) equipment which has been damaged, modified, or tampered with
in any way.
1.2 Owner and Operator's Obligations
▪The owner of this equipment must perform constancy tests at regular intervals
Eto ensure patient and operator safety. These tests must be performed in
accordance with local X-ray safety regulations.
▪The owner of this equipment must 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 must ensure inspection and cleaning work is
performed in accordance with the maintenance schedule outlined in Chapter 7
Cleaning and Maintenance.
DO NOT operate this equipment until reading this manual and reviewed
the related materials.

1. General and Regulatory Information
2 EzRay Air (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.
To prevent personal injury and/or damage to the equipment, please observe all
warnings and safety information included in this document.
WARNING
Indicates that a specific hazard is known to exist
which through inappropriate conditions or actions
may cause:
Severe personal injury (to the operator and/or
patient)
Substantial property damage.
RADIATION
HAZARD
Indicates a possible danger from exposure to
radiation.
CAUTION
Indicates that a potential hazard may exist which
through inappropriate conditions or actions will or
can cause:
Minor injury
Property damage.
IMPORTANT
Indicates that a potential problem may exist which
through inappropriate conditions or actions can
cause:
Property damage.
NOTE
Indicates precautions or recommendations that
should be used in the operation of the system,
specifically:
Using this Manual
Notes to emphasize or clarify a point.

1. General and Regulatory Information
EzRay Air (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
important information provided on the equipment.
Mark/Symbol
Description
Location
Alternate current
Battery
Charger Label
Direct current
Main Label
Attention:
Consult accompanying documents
Main Label
Dangerous voltage
Power board,
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
equipment complies with the European
Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb
device.
Main Label
CSA mark
No.266436
Main Label

1. General and Regulatory Information
4 EzRay Air (Model: VEX-P300) User Manual
Mark/Symbol
Description
Location
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 equipment 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 removal of the screw.
Main Label
Battery replacement procedure
Battery bay
access door
(inside)
This symbol indicates the direction of cover
attachment/detachment.
Cone’s upper
part

1. General and Regulatory Information
EzRay Air (Model: VEX-P300) User Manual 5
ENGLISH
1.4.1 Label Locations
1. Generator Label
2. Main Label
1
2
4
3
3

1. General and Regulatory Information
6 EzRay Air (Model: VEX-P300) User Manual
3. UDI Label
The labels in this manual are only for illustration purposes. Actual labels
may differ.

1. General and Regulatory Information
EzRay Air (Model: VEX-P300) User Manual 7
ENGLISH
1.5 Standards and Regulations
Standards:
The VEX-P300 is designed and manufactured to meet the following standards:
▪IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-65
▪X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY VEX-P300
IEC 60601-2-65:2012
▪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. 60601-2-65:15,
CAN/CSA-IEC 62366:14
▪ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, C1:2009 / (R)2012 AND
A2:2010 / (R)2012 (Consolidated text - edition 3.1)
▪ISO 13485
▪21 CFR 1020.30 & 1020.31
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment (IPX0)
Protection against electric shock: Class I equipment, Type B Applied Parts: Conehead
The CE symbol grants this equipment complies with the
European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb device.

1. General and Regulatory Information
8 EzRay Air (Model: VEX-P300) User Manual
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2. Safety Instructions
EzRay Air (Model: VEX-P300) User Manual 9
ENGLISH
2. Safety Instructions
2.1 General Safety Guidelines
This equipment is designed and manufactured to ensure the greatest
safety of operation. Operate and maintain it in strict compliance with
the safety precautions and operating instructions contained in this
manual.
This equipment must be operated only by legally qualified persons.
Observe all local fire regulations. Always keep a fire extinguisher
near the equipment.
The equipment must be installed, maintained, and serviced by
qualified service personnel according to the procedures and
preventive maintenance schedules. Only battery replacement can be
performed by users.
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.
DO NOT keep the equipment or its parts in a humid place or a liquid
substance.
Avoid placing the equipment near chemical storage and gas-filled
storage facilities.
The backscatter shield protects users from backscatter radiation that
they might be exposed during X-ray exposure. Operating the
equipment with the backscatter shield allows the users to be
exposed to less radiation compared to when operating without. For
details on the scatter data of the device configured both with and
without the backscatter shield, please review ‘10.2.3 Scattered
Dose’.
This equipment is shipped with the backscatter shield attached (firmly
fixed), so the backscatter shield cannot be replaced by users. If it is
damaged or defective, contact your Service Representative for
replacement.
Mode of operation: Continuous operation with intermittent loading—This
equipment needs a rest time of at least 30 times the exposure time
before starting the next exposure.

2. Safety Instructions
10 EzRay Air (Model: VEX-P300) User Manual
2.2 Warnings and Safety Instructions
This X-ray unit may be dangerous to patient and operator unless
safe exposure factors, operating instructions, and maintenance
schedules are observed.
It is important to read this user manual carefully and strictly abide by
all warnings and cautions stated within it.
To avoid the risk of electric shock, this equipment must only be
connected to a supply main with protective earth.
Since rules and regulations concerning radiation safety differ
between countries, it is the responsibility of the owner and/or
operator of this equipment 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 equipment.
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 fire.
Never use this equipment in an environment that is susceptible to
explosion.
DO NOT place flammable materials near this equipment.
Never touch the patient while also touching the SIP/SOP
connectors.
Medical electrical equipment is subject to special EMC preventive
measures. For more details, refer to ‘10.3 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 equipment, including the wires or cables.
Modifying this equipment may damage it beyond repair.
Serious dangers may occur from electromagnetic interference (i.e.
noise) between other equipment in the area during specific
examinations or medical treatment.
Battery chargers must be located in the accessible area where they
can be easily unplugged from the power source.

2. Safety Instructions
EzRay Air (Model: VEX-P300) User Manual 11
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
equipment and ensure correct use.
DO NOT subject batteries to mechanical shock.
In the event of a cell leaking, do not allow the liquid to come in
contact with 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 prolonged charge when not in use.
If the equipment has not been used for long periods of time, 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.
If the equipment not in use has been turned on for long periods of time,
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

2. Safety Instructions
12 EzRay Air (Model: VEX-P300) User Manual
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).
Batteries can be replaced by users.
When charging the battery, the exposure function is locked.
Be sure to turn off the equipment 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
This equipment must be operated only by properly trained, fully
qualified personnel in a controlled environment.
When using the equipment, it is recommended that all users comply
with the following radiation safety guidelines for the safety of the
users and the patients.
All users and patients should wear protective equipment, such as a
lead apron, thyroid collar, etc.
This equipment should be operated in the 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
outer end of the cone for most operator protection.