Vatech EzRay Air Wall User manual

English
User Manual
Model: VEX-S300W
Version: 1.38
Full version

Notice
EzRay Air Wall (VEX-S300W) User Manual v
Notice
The EzRay Air Wall (VEX-S300W) is an intra-oral dental X-ray system.
This manual contains descriptions, operating instructions, imaging procedures for the
EzRay Air Wall (VEX-S300W) dental X-ray system. It is recommended that you
thoroughly familiarize yourself with this manual to make the most effective use of this
equipment. Read and understand all cautions, safety messages, and warnings in this
manual.
Always keep this manual with the equipment 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:
Phone: [phone]
E-mail: [email protected]
This document is originally written in English.
The EzRay Air Wall (VEX-S300W) is referred to as Equipment or System in this
manual.
Manual Name: EzRay Air Wall (Model: VEX-S300W) User Manual
Document Number: VDH-UM-071
Version: 1.38
Publication Date: 2021-07

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EzRay Air Wall (VEX-S300W) User Manual vii
Contents
Notice v
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 Equipment .........................................................14
4. Operation 19
4.1 Power On/Off ....................................................................................19
4.2 Sleep Mode ........................................................................................20
4.3 Operation Mode .................................................................................21
4.4 Positioning.........................................................................................26
4.5 Exposure............................................................................................34
5. Troubleshooting 39
6. User Maintenance 41
7. Cleaning and Disinfection 43
7.1 Cleaning.............................................................................................44
7.2 Disinfection .......................................................................................44

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viii EzRay Air Wall (VEX-S300W) User Manual
8. Disposing of the Unit 45
9. Product Specifications 47
9.1 Mechanical Specifications ................................................................. 47
9.2 Technical Specifications .................................................................... 52
9.3 Electrical Specifications .................................................................... 55
9.4 Environmental Specifications............................................................ 56
Appendix 57

1. General and Regulatory Information
EzRay Air Wall (VEX-S300W) User Manual 1
ENGLISH
1. General and Regulatory Information
1.1 Manufacturer's Liability
The manufacturers and retailers of this equipment assume responsibility for the safe
and normal operation of this product only when:
Genuine VATECH approved equipment and components have always been used.
A VATECH authorized agent has performed all maintenance and repairs.
The equipment has been used normally following the user's manual.
The equipment damage or malfunction is not the result of an error on the part of
the owner or operator.
1.2 Owner and Operator's Obligations
The owner of this equipment shall perform constancy tests at regular intervals to
ensure patient and operator safety. These tests must be performed following local
X-ray safety regulations.
The owner of this equipment shall perform regular inspection and maintenance of
the mechanical and electrical components of this equipment to ensure safe and
consistent operation (IEC 60601-1).
The owner of this equipment shall ensure inspection and cleaning work is
performed following the maintenance schedule outlined in Chapter 6 User
Maintenance.

1. General and Regulatory Information
2 EzRay Air Wall (VEX-S300W) User Manual
1.3 Conventions Used in this Manual
The following symbols are used throughout this manual. Make sure that you fully
understand each symbol and follow the instructions which go with it.
To prevent personal injury and damage to the equipment, please see 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 patient)
Substantial property damage.
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 Wall (VEX-S300W) 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 equipment.
Mark/Symbol Description Location
Alternate current Main Label
Attention: consult accompanying
documents Main Label
Dangerous voltage
Powerboard,
X-ray
Generator,
Generator Label
Protective earth (Ground) Power Box
Base
Off (power: disconnected to the Main
Power Switch)
Main Power
Switch
On (power: connected to the Main Power
Switch)
Main Power
Switch
IEC60601-1
The degree of Protection from Electric
Shock
TYPE B Equipment
Main Label
Radiation hazard Main Label
,
Generator Label
Authorized European Representative
name and address Main 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.
Main Label
UL mark No. E476672 Main Label

1. General and Regulatory Information
4 EzRay Air Wall (VEX-S300W) User Manual
Mark/Symbol Description Location
Prescription Requirement label
Caution: Federal law restricts this
device to sale by or on the order of a
licensed healthcare practitioner.
Main Label
Manufacturer’s name and address Main Label,
Generator Label
Date of manufacture
Generator
Label,
Manufacture
Label
Serial Number
Generator
Label,
Manufacture
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
This symbol indicates the direction of
cover attachment/detachment.
Cone’s upper
part

1. General and Regulatory Information
EzRay Air Wall (VEX-S300W) User Manual 5
ENGLISH
1.4.1 Label Locations
1. UDI Label
2. Main Label
3. Generator and manufacture Label
The labels in this manual are only for illustration purposes.
Actual labels may differ.
The Canadian warning label (See below) is attached only to
products sold in Canada.
2
1
2
3

1. General and Regulatory Information
6 EzRay Air Wall (VEX-S300W) User Manual
1.5 Standards and Regulations
Standards:
The EzRay Air Wall (VEX-S300W) is designed and manufactured to meet the following
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)
21 CFR 1020.30 & 1020.31
ISO 13485
This is Class IIb equipment and obtained CE marking in April
2007 for regulations 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 I equipment, Type B Applied Parts: Conehead

2. Safety Instructions
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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.
Legally qualified persons must only operate this equipment.
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.
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 near a liquid
substance.
Avoid placing the equipment near chemical storage and gas-filled storage
facilities.

2. Safety Instructions
8 EzRay Air Wall (VEX-S300W) 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 essential 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 supply mains with protective earth.
Since rules and regulations concerning radiation safety differ
between countries, it is the responsibility of the owner and
operator of this equipment to comply with all applicable rules
and regulations concerning radiation safety and protection in
their area.
Never expose this equipment to liquids, mists or sprays. Exposing this equipment
to liquids may cause an electrical shock or otherwise damage the system.
Never use this equipment in an environment that is susceptible to explode.
Never touch the patient while also touching the SIP/SOP connectors.
Never try to modify this equipment, including the wires or cables. Modifying this
equipment may damage it beyond repair.
DO NOT open or remove the cover panels on this equipment.
DO NOT use spray cleaners on this equipment, as this could cause a fire.
DO NOT place flammable materials near this equipment.
The medical electrical equipment is subject to special EMC preventive measures.
For more details, refer to Section A.3 Electromagnetic Compatibility (EMC)
Information.
We recommend that the patient and the operator wear protective lead-lined
aprons unless other Radiation Protection Protocols apply locally.
Children and pregnant women must consult with a doctor before X-ray exposure.
Serious dangers may occur from electromagnetic interference (i.e., Noise)
between other equipment in the area during specific examinations or medical
treatment.

2. Safety Instructions
EzRay Air Wall (VEX-S300W) User Manual 9
ENGLISH
Radiation Safety
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.
This equipment should be operated by a trained and qualified dentist or a dental
technician in a controlled environment.
All users and patients should wear protective equipment, such as a lead apron,
thyroid collar, etc.
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.
Any person or organization that installs an external Door Interlock Switch is
responsible for ensuring that the Switch has a radiation indicator or an equivalent
alarm system to show the state of the current.
This equipment should be operated at least 2 m away from the operator when
operated in or outside of the room. For details on the Scattered Dose data, please
see ‘Scattered Dose’ on page 64 in the Appendix.

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3. System Overview
EzRay Air Wall (VEX-S300W) User Manual 11
ENGLISH
3. System Overview
The EzRay Air Wall (VEX-S300W)is an intra-oral dental X-ray system intended for
intra-oral imaging. It consists of an X-ray generator, an X-ray controller, a beam limiting
device, an operation panel, and a mechanical arm. The X-ray controller allows for
accurate exposure control, and the adjustable mechanical arm allows for easy
positioning. The system can be used with an imaging system.
3.1 Indications for Use
The EzRay Air Wall (VEX-S300W)is an intra-oral dental X-ray system (extra-oral X-
ray source system) intended for use by a trained and qualified dentist or dental
technician for both adult and pediatric subjects for producing diagnostic dental
radiographs for treatment of diseases of the teeth, jaw, and other oral structures using
intra-oral image receptors.
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 the anode to produce X-rays. The
equipment 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.