Vatech EzRay Air W User manual

Notice
EzRay Air W (Model: VEX-S300W) User Manual v
Notice
The VEX-S300W is an intra-oral dental X-ray system.
This manual contains descriptions, operational instructions, imaging procedures for the
VEX-S300W dental X-ray system. It is recommended that you thoroughly familiarize
yourself with this manual in order to make the most effective use of this equipment.
Read and understand all cautions, safety messages and warnings in this manual.
Keep this manual with the equipment at all times, and review the operation procedures
and safety instructions if needed.
The illustrations/photos of the equipment in this manual are only for illustration
purposes. 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: [e-mail]
This document is originally written in English.
The VEX-S300W is referred to as Equipment or System in this manual.
Manual Name: EzRay Air W (Model: VEX-S300W) User Manual
Version: 1.0
Publication Date: 2016-10

Notice
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Table of Contents
EzRay Air W (Model: VEX-S300W) 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 ........................................................................................ 12
3.6 General View of the Equipment ....................................................... 13
4. Operation...........................................................................................19
4.1 Power On/Off................................................................................. 19
4.2 Operation Mode ............................................................................. 20
4.3 Positioning ..................................................................................... 25
4.4 Exposure ....................................................................................... 36
5. Troubleshooting ................................................................................41
6. User Maintenance..............................................................................43
7. Disposing of the Unit .........................................................................45
8. Product Specifications .......................................................................47
8.1 Mechanical Specifications ............................................................... 47
8.2 Technical Specifications .................................................................. 52
8.3 Electrical Specifications................................................................... 56
8.4 Environmental Specifications........................................................... 57
Appendix........................................................................................................ A-1
A.1 Tables of Exposure Times (Default)………………………………………………A-1
A.2 X-ray Dose Data…………………………………………………………………………A-3
A.3 Electromagnetic Compatibility (EMC) Information…………………………A-13
A.4 Abbreviations…………………………………………………………………………. A-16

Table of Contents
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1. General and Regulatory Information
EzRay Air W (Model: VEX-S300W) 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 product only when:
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.
1.2 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 work is
performed in accordance with the maintenance schedule outlined in Chapter 6
User Maintenance.

1. General and Regulatory Information
2 EzRay Air W (Model: 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 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.
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 W (Model: VEX-S300W) 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 Main Label
Attention: consult accompanying
documents Main Label
Dangerous voltage
Power board,
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
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
CSA mark
No.266436 Main Label

1. General and Regulatory Information
4 EzRay Air W (Model: 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 Main Label,
Generator Label
Serial Number 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
This symbol indicates the direction of
cover attachment/detachment.
Cone’s upper
part

1. General and Regulatory Information
EzRay Air W (Model: VEX-S300W) User Manual 5
ENGLISH
1.4.1 Label Locations
1. UDI Label
2. Main Label
3. Generator Label
The labels in this manual are only for illustration purposes. Actual
labels may differ.
2
1
2
3

1. General and Regulatory Information
6 EzRay Air W (Model: VEX-S300W) User Manual
1.5 Standards and Regulations
Standards:
The VEX-S300W is designed and manufactured to meet the following standards:
IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65,
IEC 62366
X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY VEX-S300W
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
The CE symbol grants this equipment compliance with the
European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb device.
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: Cone head

2. Safety Instructions
EzRay Air W (Model: VEX-S300W) User Manual 7
ENGLISH
2. Safety Instructions
2.1 General Safety Guidelines
Mode of operation: Continuous operation with intermittent loading—This
equipment needs a rest time of at least 60 times the exposure time before starting
the next exposure.
This equipment is designed and manufactured to ensure maximum safety of
operation. Operate and maintain it in strict compliance with the safety precautions
and operating instructions contained in this manual.
This equipment must only be operated 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.
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.
Don’t 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 W (Model: 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 important to read this user manual carefully and strictly abide by all
warnings and cautions stated within it.
To avoid risk of electric shock, this equipment must only be connected
to a supply mains 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 Section A.3 Electromagnetic Compatibility (EMC)
Information.
Never try to modify this equipment, including the wires or cables. Modifying this
equipment may damage it beyond repair.
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 W (Model: VEX-S300W) User Manual 9
ENGLISH
Radiation Safety
When using the equipment, it is recommended that all users comply
with the following radiation safety guidance 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 who 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 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 A-9 in Appendix.

2. Safety Instructions
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3. System Overview
EzRay Air W (Model: VEX-S300W) User Manual 11
ENGLISH
3. System Overview
The VEX-S300W is an intra-oral dental X-ray system intended for intra-oral imaging. It
consists of X-ray generator, X-ray controller, beam limiting device, operation panel and
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 W (Model: 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 high voltage is supplied to the X-ray tube assembly which
frees electrons from cathode. They hit anode to produce X-rays. The equipment
acquires images by emitting X-rays continuously on human tooth.
3.3 Intended User Profile
Considerations Requirement Description
Education
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 W (Model: VEX-S300W) User Manual
3.4 Components
No. Item Standard Option Qt y.
1 Power Box Assembly ●1
2 Scissor Arm Assembly ●1
3 X-ray Generator Assembly ●1
4 User Manual ●1
5 Installation Manual ●1
6 Round Cover ●1
7 Remote Exposure Switch*●●1
8 Remote Exposure Switch
(Doorbell type) ●1
9
Remote Exposure Switch Cable
(Doorbell type) ●1
10 Door Interlock Cable ●1
11 AC Power Cable ●1
12 Rectangular Cover (2x3) ●1
13 Rectangular Cover (4x3) ●1
14 Double Stud ●1
15 Horizontal Arm
Assembly
450 mm ●1
16 Horizontal Arm
Assembly
600 mm ●1
17 Horizontal Arm
Assembly
900 mm ●1
* The standard Remote Exposure Switch can be additionally provided as an
optional item if needed. For details on the Remote Exposure Switch and Power Cable
Connections, please see ‘Section 4.4.1’ on page 37 and 38.
3.5 Features
The VEX-S300W is an intra-oral dental X-ray system that offers safety, reliability, and
greater functionality:
Ergonomic design and shape for safety and comfort of patients
Easy-to-use Control Panel that provides a straightforward process
Full-swivel revolution in all directions
Tube head revolves freely around the sphere
Compact, lightweight components