Vatech EzRay Premium VEX-S100W User manual

Full version
User manual
Model: VEX-S100W
Version: 1.35
• English
Postal code: 18449
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea
www.vatech.co.kr
User manual

Notice
EzRay Premium User Manual v
Notice
The EzRay Premium is an advanced digital dental diagnostic system.
This manual contains descriptions, operational instructions, imaging procedures for the
EzRay Premium Dental X-Ray system. It is recommended that you thoroughly
familiarize yourself with this manual to make the most effective use of this equipment.
Observe all cautions, safety messages and warnings that appear in this manual.
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 EzRay Premium is referred to as Equipment in this manual.
Manual Name: EzRay Premium (Model: VEX-S100W) User Manual
Document number: VDH-UM-056
Version: 1.35
Publication Date: 2020-08

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EzRay Premium 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 in this Manual .................................................................2
1.4 Marks and Symbols..............................................................................3
1.5 Standards and Regulations..................................................................4
2. Safety Instructions 7
2.1 General Safety Guidelines ...................................................................7
2.2 Warnings and Safety Instructions.......................................................7
3. The System Overview 9
3.1 Indication for Use................................................................................9
3.2 Features...............................................................................................9
3.3 General View of the Equipment.........................................................10
3.4 Control Panel.....................................................................................12
4. Preparations for Exposure 17
4.1 Turning the Equipment On ................................................................17
4.2 Selecting the Cone Type....................................................................18
5. Using the System 19
5.1 Exposure Parameters ........................................................................19
5.2 Positioning.........................................................................................20
5.3 Exposure............................................................................................25
5.4 Tables of Exposure Times (Default) ..................................................26
5.5 X-Ray Generation Limit .....................................................................27
6. Emergency Measures 29

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viii EzRay Premium User Manual
7. Cleaning and Disinfection 33
7.1 Cleaning ............................................................................................ 34
7.2 Disinfection .......................................................................................34
8. Maintenance 35
8.1 Maintenance......................................................................................35
9. Service 37
10. Disposing of the Unit 39
11. Technical Specifications 41
11.1 Mechanical Specifications ................................................................. 41
11.2 Technical Specifications....................................................................43
11.3 Electrical Specifications ....................................................................46
11.4 Environmental Specifications............................................................46
12. X-Ray Dose Data 47
12.1 X-Ray Dose Table ..............................................................................47
12.2 Leakage Dose Test Report.................................................................48
13. Electromagnetic Compatibility (EMC) Information 51

1. General and Regulatory Information
EzRay Premium 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:
The equipment has been installed by a VATECH authorized technician.
The equipment has been installed in accordance with all the cautions and
conditions required for installation.
Genuine VATECH approved equipment and components have been used always.
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 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 7 Cleaning and
Maintenance.

1. General and Regulatory Information
2 EzRay Premium User Manual
1.3 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.
WARNING
Indicates information that should be followed with
the utmost care. Failure to comply with a warning
may result in severe damage to the equipment or
physical injury to the operator and/or patient.
CAUTION Indicates a situation that demands prompt and careful action, a specific remedy, or emergency
attention.
IMPORTANT Indicates a situation or action that could potentially cause problems to the equipment and/or its
operation.
NOTE Emphasizes valuable information or provides useful
tips and hints.

1. General and Regulatory Information
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1.4 Marks and Symbols
Symbols Description Location
Alternate current
Attention: consult accompanying documents Label
Dangerous voltage Power board
Protective earth (Ground) Power board
Off (power: disconnect from the main switch) Main switch
On (power: connect to the main switch) Main switch
IEC60601-1
The degree of Protection from Electric Shock
TYPE B Equipment Label
Radiation hazard Label
EC representative 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.
Label
CSA mark
No.266436 Label
Address where the equipment was
manufactured Label

1. General and Regulatory Information
4 EzRay Premium User Manual
Symbols Description Location
This symbol indicates that electrical and
electronic equipment must not be disposed
of as unsorted municipal waste and must be
collected separately.
Label
ESD susceptibility symbols indicate that an
item is susceptible to damage from
electrostatic discharges.
Board
package
This symbol indicates that this equipment is
classified as a CLASS 1 LASER PRODUCT
in accordance with IEC 60825-1 ED.1
regulations.
Label
Date of manufacture Label
Refer to the Instruction manual Label
Caution:
Federal law restricts this device to sale by or
on the order of a licensed healthcare
practitioner.
Label
Indicates the manufacturer's serial number
so that the specific equipment can be
identified. Label
1.5 Standards and Regulations
Standards:
The EzRay Premium is designed and manufactured to meet the following standards:
IEC/EN/UL 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3,
IEC/EN 60601-2-7, IEC/EN 60601-2-28, IEC/EN 60601-2-32,
ISO 9001, ISO 13485
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
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Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment: IPX0.
Protection against electric shock: Class I equipment, Type BApplied Parts.

1. General and Regulatory Information
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2. Safety Instructions
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2. Safety Instructions
2.1 General Safety Guidelines
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.
Install this Equipment in an x-ray room that complies with current installation
standards. You must be able to maintain visual or audio communication with the
patient from this location.
Observe all local fire regulations. Always keep a fire extinguisher near the
equipment.
There are no user-serviceable parts in this equipment. The equipment must be
installed, maintained, and serviced by qualified service personnel according to
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.
2.2 Warnings and Safety Instructions
X-Ray equipment is hazardous to the patient and the operator if proper
exposure safety measures and/or operating instructions are not
observed.
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.
The room where your radiology equipment is to be installed must
comply with all official regulations applicable for the protection against
radiation. You must install your radiology equipment in a room
protected against x-ray emission.
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.

2. Safety Instructions
8 EzRay Premium User Manual
Do not place flammable materials near this equipment.
Never touch the patient while also touching the SIP/SOP connectors.
Do not connect this equipment to a Multiple Portable Socket-Outlet (MPSO) or
extension cord.
The EzRay Premium X-Ray equipment complies with IEC standard 60601-1-2.
Medical electrical equipment is subject to special EMC preventive measures. It
must be installed and operated as specified in the Installation Requirements
document. For more details, refer to Chapter 12 Electromagnetic Compatibility
Information.
Never try to modify this equipment, including the wires or cables. Modifying this
equipment may damage it beyond repair.
The operator must remain 6 ft. (2 m) away from the focal spot and the X-ray
beam always for safety.
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.

3. The System Overview
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3. The System Overview
EzRay Premium is an intraoral source dental X-ray system intended for intraoral
imaging. It consists of an X-ray generator, X-ray controller, beam limiting device, an
operation panel, and a mechanical arm. The X-ray controller allows for accurate
exposure control, and an adjustable mechanical arm allows for easy positioning. The
system can be used either with conventional film or a digital imaging system.
3.1 Indication for Use
The EzRay Premium(VEX-S100W) is an extraoral source of X-rays, intended to be
used for producing diagnostic dental radiographs for treatment of disease of the teeth,
jaw and oral structures.
3.2 Features
The EzRay Premium is intra-oral X-ray imaging equipment that offers safety, reliability,
and greater functionality:
Full-swivel revolution in all directions
Tube head revolves freely around the sphere
Reduced radiation dosage
Compact, lightweight components
A selection of film or digital sensors
Ergonomic design and shape for the safety and comfort of patients
The easy-to-use control panel that provides a straightforward process

3. The System Overview
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3.3 General View of the Equipment
3
4
6
7
1
2
5
8
No. Item Description
1 Cone
(Collimator) Varied sizes adapted to films and digital sensors.
2 Tube Head Generates high–frequency X-rays
3, 4 Articulating Arm Extends the arm
5 Horizontal Arm 3 length options: 450 mm, 600 mm, 900 mm
6 On / Off switch Turns the equipment ON/OFF
7 Control Panel
Controls and manages the system; Anatomical
selection, receptor type and digital display of
parameters (kV, mA, Exposure Time).
For more details, refer to “3.4 Control Panel”.
8 LED Lamp Indicates current exposure activity.
Green: Ready, Orange: X-Ray ON
Do not hang lead aprons on the arm.

3. The System Overview
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Available Option Items
Arm’s length available: 450 mm, 600 mm, or 900 mm.
Conehead (Collimator): 6 types;
Shape Length
(from the focal spot to edge of the cone) Diameter
Round 200 mm default 60 ± 2(mm)
300 mm optional 60 ± 2(mm)
Rectangular
- optional FOV: 2 X 3(cm)
FOV: 3 X 4(cm)
- optional FOV: 2 X 3(cm)
FOV: 3 X 4(cm)
Separate exposure switch (If the control panel is installed to the wall framework)
Exposure Indicator light
Green:Ready
Orange: X-Ray On
Exposure Button

3. The System Overview
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3.4 Control Panel
24
6
79 8
1
3
5
No. Description
1 Exposure Button
2 X-Ray Emission Indicator
3 LCD (kV, mA, Time, Error Code, DAP)
4 Power Status Indicator
5 Parameter Adjustment Button
6 Save Button
7 Tooth Selector
8 Adult / Child Selector
9 Receptor Selector