(EzRay - 100U - 57A - En) User Guide

Notice
Notice
The EzRay is an advanced digital dental diagnostic system.
This manual contains descriptions, operational instructions, imaging procedures for the
EzRay 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.
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: +82-1588-9510
E-mail: gcs@vatech.co.kr
This document is originally written in English.
The EzRay is referred to as Equipment in this manual.
Manual Name: EzRay (Model: VEX-S100W) User Manual
Version: 1.0.0
Publication Date: 2013-9
Copyright © 2013 by VATECH
All rights reserved.

The documentation, brand name, and logo used in this manual are copyrighted. No
part of this manual may be reproduced, transmitted, or transcribed without the
expressed written permission of the manufacturer. We reserve the right to make any
alterations which may be required due to technical improvement.
Manufactured by VATECH Co., Ltd.

Headquarters: 23-4, Seogu-dong, Hwaseoung-si, Gyeonggi-do, Korea
Factory: 23-4, Seogu-dong, Hwaseoung-si, Gyeonggi-do, Korea
EzRay User Manual v

Notice
Left blank intentionally
vi EzRay User Manual

Table of Contents
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 .............................................................................. 5
2.1 General Safety Guidelines ................................................................. 5

2.2 Warnings and Safety Instructions ...................................................... 5
3. The System Overview .......................................................................... 7
3.1 Indication for Use ............................................................................. 7

3.2 Features .......................................................................................... 7
3.3 General View of the Equipment ......................................................... 8
3.4 Control Panel ................................................................................. 10
4. Preparations for Exposure ................................................................. 15
4.1 Turning the Equipment On .............................................................. 15

4.2 Selecting the Cone Type ................................................................. 16
5. Using the System ............................................................................... 17
5.1 Exposure Parameters ...................................................................... 17

5.2 Positioning ..................................................................................... 18
5.3 Exposure ....................................................................................... 23
5.4 Tables of Exposure Times (Default) ................................................. 24
5.5 X-Ray Generation Limit ................................................................... 25
6. Emergency Measures ......................................................................... 27
7. Cleaning and Maintenance ................................................................ 31
8. Service ............................................................................................... 33
9. Disposing of the Unit ......................................................................... 35
10. Technical Specifications .................................................................... 37
10.1 Mechanical Specifications ............................................................... 37

10.2 Technical Specifications .................................................................. 39
10.3 Electrical Specifications................................................................... 45
10.4 Environmental Specifications........................................................... 45
EzRay User Manual vii

Table of Contents
11. X-Ray Dose Data ............................................................................... 47
11.1 X-Ray Dose Table ........................................................................... 47

11.2 Leakage Dose Test Report .............................................................. 48
12. Electromagnetic Compatibility (EMC) Information ........................... 51
viii EzRay User Manual

1. General and Regulatory Information
ENGLISH
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 of the cautions and
conditions required for installation.
 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 7 Cleaning and
Maintenance.
EzRay User Manual 1

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.
Indicates information that should be followed with the

utmost care. Failure to comply with a warning may
WARNING
result in severe damage to the equipment or physical
injury to the operator and/or patient.
Indicates a situation that demands prompt and

CAUTION careful action, a specific remedy, or emergency
attention.
Indicates a situation or action that could potentially

IMPORTANT cause problems to the equipment and/or its
operation.
Emphasizes important information or provides useful

NOTE
tips and hints.
2 EzRay User Manual

1.4 Marks and Symbols
ENGLISH
Symbols Description
Alternate current
Attention: consult accompanying documents
Protective earth (Ground)
Off (power: disconnect from the main switch)
On (power: connect to the main switch)
TYPE B Equipment
Radiation hazard
EC representative
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.
UL mark : UL 60601-1 / CAN/CSA

C22.2 No.601.1
Address where the equipment was manufactured
This symbol indicates that electrical and electronic

equipment must not be disposed of as unsorted
municipal waste and must be collected separately.
EzRay User Manual 3

1.5 Standards and Regulations
Standards:
The EzRay 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 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.
4 EzRay User Manual

2. Safety Instructions
ENGLISH
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.
EzRay User Manual 5

 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 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 at all times 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.
6 EzRay User Manual

3. The System Overview
ENGLISH
EzRay is an intraoral source dental X-ray system intended for intraoral 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 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 is an intraoral source of X-rays, intended to be used for producing

diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral
structures.
3.2 Features
The EzRay 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
 Easy-to-use control panel that provides a straightforward process
EzRay User Manual 7

3.3 General View of the Equipment
3
4
8
1
6
No. Item Description

Cone
1 Different sizes adapted to films and digital sensors.
(Collimator)
2 Tube Head Generates high–frequency X-rays
3, 4 Articulating Arm Extends the arm
5 Horizontal Arm 3 arm lengths (optional): 450 mm, 600 mm, 900 mm
6 On / Off switch Turns the equipment ON/OFF
Controls and manages the system; Anatomical
selection, receptor type and digital display of
7 Control Panel parameters (kV, mA, Exposure Time).
For more details, refer to “3.4 Control Panel”.
Indicates current exposure activity.
8 LED Lamp
Green: Ready, Orange: X-Ray ON
Do not hang lead aprons on the arm.
8 EzRay User Manual

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

Green: Ready
Orange: X-Ray On
EzRay User Manual 9

3.4 Control Panel
2
4
9 8 7 6
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
10 EzRay User Manual

1. Exposure button
ENGLISH
When you take an exposure you must press and hold down the exposure button for
the duration of the exposure.
2. X-Ray emission indicator
Ready: turns green (1.5 sec)
X-Ray On: turns orange
Refer to the section 5.4 Tables of Exposure Time.
COOLING TIME:
The equipment requires a cooling time equal to 15 times the exposure
time before taking another image. The cooling time is displayed on the
LCD. You can use the Exposure button only after the cooling time has
passed.
3. LCD (Liquid Cristal Display)
Displays the exposure conditions (tube voltage, tube current, exposure time, and DAP)
based on the environmental options (e.g. patient type, tooth).
 kV: Tube voltage
 mA: Tube current
 Sec: Exposure time
 DAP: Dose Area Product
4. Power status indicator
If power is ON, the light turns green
EzRay User Manual 11

5. Parameter Adjustment Key
The preprogrammed settings (tube voltage/current and exposure time) can be

changed by the user. For manual adjustment, refer to “5.5 X-ray Generation Limits”.
Icon Meaning
Parameter Adjustment key: kV → mA → sec in a cycle.
Up / Down for the kV, mA, and sec.

Adjustable range allowed:
Tube voltage (kV) 60 - 70 (Default), 50 - 70 (Optional),
Tube current (mA) 4.0 - 7.0
Exposure time (sec) 0.04 - 2
Resolution(Tube voltage/current/exposure time): 1 kV/1.0 mA /

0.01 sec
6. Save Button
Select the exposure conditions and hold down the Save button for two seconds to
save changed settings. Use this when you need to change the default exposure
conditions, such as kV, mA, or sec.
7. Tooth Selector
Icon Meaning
Premolar
Incisor
Molar
Bitewing

8. Adult / Child selector
ENGLISH
Icon Meaning
Adult
Child
9. Receptor selector
Icon Meaning
Film
Digital


4. Preparations for Exposure
ENGLISH
4.1 Turning the Equipment On
Turn ON the equipment. The following displays light up:
 Power status indicator
 Anatomical selector
 Adult or Child selector
 Receptor selector
 Displays the exposure parameters: kV, mA and exposure time

4.2 Selecting the Cone Type
Select the cone type to be used in the exposure. Use of the optional long cone is
recommended in order to keep the patient’s absorbed dose as low as possible.
Assembling the Cone: Long 30 cm (12″) Cone
The long cone is attached into position by pushing it into the short cone and rotating it
so that the guide lines on the short cone and long cone line up.
①
②
In position: guide lines line up
Assembling the Cone: Rectangular Collimator
The rectangular collimator can be attached to the short (200 mm) or long (300 mm)
cone.
The rectangular collimator is attached into position by pushing it into the cone and
rotating it so that the guide lines on the cone and the rectangular collimator line up.
In position: guide lines line up
Cone Labels : 2 x 3, 3 x 4

5. Using the System
5. Using the System
ENGLISH
5.1 Exposure Parameters
1. Select the receptor type: Film or Digital sensor. The indicator light of the selected
projection will turn on.
2. Select the type of patient: Adult or Child. The indicator light of the selected projection
will turn on.
3. Select the tooth where an image is to be taken. The indicator light of the selected
projection will turn on.
The preprogrammed time, kV, and mA values appear on the LCD display. It may be
necessary to increase or decrease the kV and mA, or time from the preset values for
one exposure.
To do so:
a. Press the parameter adjustment key ( ).
b. Increase or decrease the values by using the up or down button ( ).
c. Press any other button (Tooth, Film, or Patient Type) to return the display to the
preset values. For manual adjustment, refer to the section 5.5 X- ray Generation
Limit.
X-ray generation limit value is determined in units of kV x mA

based on the exposure time.
If the parameter you set exceeds the safety limit, the “Over Value”
message is displayed on the top left of the LCD. Unless this
message is cleared, you cannot perform irradiation.
You can change the default values by performing steps ①~②
and pressing the Save ( ) button. If you want to reset to the

factory-default settings, contact the service center.

5. Using the System
5.2 Positioning
Positioning the Patient
To obtain high-quality intraoral radiography with maximum details, take extra care in all
steps of the radiography process: positioning the patient, the x-ray generator, and the
imaging system; exposing the film or the intra oral sensor; and processing the film.
The long cone (optional) can be attached into the short cone.
Refer to section “4.2 Selecting the Cone Type”.
1. Guide the patient to the equipment.

2. Place a protective lead apron over the patient’s chest.
3. Have the patient sit on the chair with the sagittal plane vertical.
 For radiography of the upper maxillary, the Frankfort plane must be horizontal.
 For radiography of the lower maxillary, the occlusal plane must be horizontal.
4. Place the EzRay’s cone on the area you want to take an image.
For further information about the patient positioning and beam angle for each mode,
refer to following Positioning Instructions.
During patient positioning or X-ray exposure, avoid touching the

patients skin with the EzRay’s cone.

5. Using the System
Positioning Instructions
ENGLISH
Paralleling technique: the film or sensor is placed in a film holder which is used to align
the film parallel to the long axis of the teeth.
1. Film or Sensor
2. Long axis of the tooth
Bisected angle technique: the patient holds the film or sensor in place with his / her
finger. The X-ray beam is directed perpendicularly towards an imaginary line, which
bisects the angle between the film plane and the long axis of the tooth.
1. Film or Sensor
2. Long axis of the tooth
Position the tube head to the patient using the accepted standard positioning
procedures.
Here are the specific angulations and directions for the tube head in order to take the
best images possible of a particular tooth (Ex: Bisected angle technique).
Position the receptor carefully not to damage the soft tissue of the
patient’s intra-oral area.

5. Using the System
 Maxillary Incisor
X-Ray beam is directed downward at 45°.
 Mandibular Incisor
X-Ray beam is directed upward at 25°.
Teeth Angle of inclination
Incisor Maxilla +45˚
Incisor Mandible -25˚

5. Using the System
 Maxillary Molar and Premolar
ENGLISH
X-Ray beam is directed downward at 30°.
 Mandibular Molar and Premolar
X-Ray beam is directed upward at 5°.
Molar and Premolar Maxilla +30˚
Molar and Premolar Mandible -5˚

5. Using the System
 Bitewing
For a bitewing exposure, the patient closes their teeth during exposure on the
film’s tab or on the film / sensor holder.
X-ray beam is directed downward at 5° ~ 8°.
Bitewing exposure +5˚~ +8˚
Positioning the Imaging Receptor
Using the EzRay Intra-oral X-ray system, you may create an X-ray image on one of
three different types of imaging receptors:
 Conventional dental films
 Digital sensors, such as VATECH’s EzSensor
 Phosphor plate
Placing the receptor properly is important. Check your dental radiography text for
information about the proper placement of the imaging receptor. Improperly positioning
the film or sensor results in errors on the radiograph, such as distorted teeth and roots,
elongation, magnification, and/or overlapping contacts.
The paralleling technique generally reduces the risk of such errors. However, if you
improperly position the receptor, angulation errors can occur (angulation of the
receptor to the tooth itself).
If the exit pattern of the beam is not aligned with the imaging receptor, then part of the
radiograph will not be exposed to radiation and the final radiograph will have some
clear (unexposed) areas.

5. Using the System
5.3 Exposure
ENGLISH
The operator must instruct the patient to refrain from moving during the
entire exposure.
1. Ask the patient not to move.

2. Move as far away from the X-ray tube as the length of the cable from the control panel
permits. The distance must be at least 2 m (6.6 ft) from the X-ray tube.
3. Press the exposure button or the separate exposure switch for the duration of the
exposure.
While X-Ray is being exposed,
 The X-ray emission indicator lights up and an audible sound is produced.
 Keep pressing until the X-ray emission light goes out and the audible sound stops.
Ready: Green (1.5 s)

X-Ray on: Orange
The DAP value is displayed on the LCD if it is set to be displayed.
Hold the exposure button or switch at least as long as the acoustic

signal can be heard. Otherwise the exposure will be faulty and there
will be an error message in the display.
Wait for at least 15 times the exposure time to cool down the tube
temperature before taking another image.
Notice that the LED on the X-ray emission indicator blinks while the
tube is cooling down.

5. Using the System
5.4 Tables of Exposure Times (Default)
The following exposure time tables were established with a unit equipped with a cone
that corresponds to a focus-to-skin distance of 20 cm (8 inches) and 30 cm (12 inches)
respectively.
Standard: Option:
Cone 20 cm Cone 30 cm
Receptor
Adult (8 inches) (12 inches)
kV mA sec kV mA sec
Incisor 60 7 0.08 70 6 0.13
Premolar 60 7 0.12 70 6 0.18

FILM
Molar 60 7 0.17 70 6 0.25
Bitewing 60 7 0.18 70 6 0.27
Incisor 60 7 0.07 70 6 0.11
Premolar 60 7 0.10 70 6 0.16

SENSOR
Molar 60 7 0.13 70 6 0.20
Bitewing 60 7 0.14 70 6 0.21
Standard: Option:
Cone 20 cm Cone 30 cm
Receptor
(8 inches) (12 inches)
Child
kV mA sec kV mA sec
Incisor 60 7 0.05 70 6 0.08
Premolar 60 7 0.07 70 6 0.11

FILM
Molar 60 7 0.11 70 6 0.14
Bitewing 60 7 0.11 70 6 0.14
Incisor 60 7 0.04 70 6 0.07
Premolar 60 7 0.06 70 6 0.10

SENSOR
Molar 60 7 0.08 70 6 0.13
Bitewing 60 7 0.09 70 6 0.14

5. Using the System
5.5 X-Ray Generation Limit
ENGLISH
Tube Voltage, Tube Current, and Exposure Time value cannot be set
to the maximum value simultaneously.
If the parameter you set exceeds the safety limit, the “Over Value”
message is displayed on the top left of the LCD. Unless this message
is cleared, you cannot perform irradiation.
Tube Voltage (kV) Tube Current (mA) Exposure Time (sec)

50 ~ 56 7 0.04 ~ 2.0
50 ~ 65 4~6 0.04 ~ 2.0
61 ~ 70 7 Not available
66 ~ 70 4~5 0.04 ~ 2.0
57 7 0.04 ~ 1.7
58 7 0.04 ~ 1.3
59 7 0.04 ~ 1.0
60 7 0.04 ~ 0.5
66 6 0.04 ~ 1.8
67 6 0.04 ~ 1.5
68 6 0.04 ~ 1.2
69 6 0.04 ~ 0.9
70 6 0.04 ~ 0.5
Adjustable step: 1 kV, 1 mA, 0.01 sec

5. Using the System

6. Emergency Measures
ENGLISH
In instances of abnormal operation, error messages will be displayed on the LCD
panel. If a problem persists, please request assistance from the customer support
information services.
Error Messages
Error Code Cause Actions to be taken

Turn off the power and check the
connection between the panel board
The connection between and the inverter board.
E01 the panel board and the
inverter board is bad. If the connection is normal but the
error still occurs, contact the service
center.
Recycle the power of the equipment
The connection between
by turning it off and on. If the error
E02 the mono-tank block and
still occurs, contact the service
the inverter board is bad.
center.
The current flows above
the maximum current
E03 allowed when the inverter "
is activated (when you
perform the irradiation).
Turn off the equipment, let the mono-
The mono-tank block
tank block cool down sufficiently and
E08 temperature exceeds the
turn on the equipment again (error
error limit (50 degrees).
limit: 50 degrees).
Recycle the power of the equipment
The high voltage current is
by turning it off and on. If the error
E09 abnormal during X-ray
still occurs, contact the service
irradiation.
center.
The error is reset after 10 seconds.
The X-ray On command After the reset, you can perform the
E10
was not recognized. irradiation. If the error continues,
contact the service center.
The X-ray Off command
was not issued within 0.5 Turn off the equipment and check if
seconds after irradiation the exposure switch is connected
E11 (after the exposure switch properly. If the switch is connected
was turned off). That is, the properly but the error still occurs,
X-ray Off command was contact the service center.
not recognized.
The kV feedback is lower Recycle the power of the equipment
than the set value by more by turning it off and on. If the error
E12
than – 20 kV during X-ray still occurs, contact the service
irradiation. center.

Error Code Cause Actions to be taken

The kV feedback is higher
than the set value by more
E13 "
than + 20 kV during X-ray
irradiation.
The mA feedback is lower
E14 "
than 50 % during X-ray
irradiation.
The mA feedback is higher
E15 "
than 50 % during X-ray
irradiation.
Check if the exposure switch is
already pressed when you turned on
the equipment.
The exposure switch is
Once the switch is released, the
E60 already pressed when you
equipment functions properly.
turned on the equipment.
If the exposure switch is released but
the equipment does not function
properly, contact the service center.
The error is reset after 10 seconds.
The exposure switch is After the reset, you can perform the
E61 released earlier than the irradiation.
time specified on the LCD. If the error continues, contact the
service center.

Troubleshooting
ENGLISH
Problem Cause Solution
Equipment is
Connect the equipment
Nothing lights up disconnected
Circuit breaker is tripped Reset the Circuit breaker
Control unit is
Control unit does not light Connect the control unit
disconnected
up
Control unit is defective Call a qualified technician
Check if the power plug is
Equipment does not turn
Power failure plugged properly into the
on
power socket
Wait for the COOLING
Generator is cooling
message to disappear
Exposure button is Call a qualified service
No X-ray emission defective technician
Check if exposure switch
Exposure switch failure is properly connected to
the equipment
Wrong receptor type is
Change the receptor type
being used
Generator is positioned Adjust the position of the
X-ray emission works, but incorrectly generator
exposure is too light or
completely white Increase the exposure
Exposure time is too short
time
Receptor is facing the
Reposition the receptor
wrong way
Wrong receptor type is
Change the receptor type
X-ray emission works, but being used
exposure is too dark Decrease the exposure
Exposure time is too long
time


7. Cleaning and Maintenance
ENGLISH
 The equipment surfaces can be cleaned with a soft cloth damped in an alcohol-
based, non-corrosive cleaning solution.
 Sterilization and disinfection should be performed thoroughly for items that have
been in frequent contact with patients and operators.
 If necessary, wipe off surfaces with disinfectant.
 The film holder can be autoclaved up to 145 ˚C or cleaned with alcohol-based

solutions.
When cleaning the surfaces, always disconnect the equipment

from mains.
Do not allow liquids to drop into the equipment.
Do not use spray cleaner or disinfectant directly onto the
equipment, as this could cause a fire.
 Do not use force to unplug cables.
 Don’t keep the equipment or its parts in a humid place or near a liquid substance.
 Avoid placing the equipment in an area that has some degree of slope, vibration,
or shock.
 Avoid placing the equipment near chemical storage and gas-filled storage
facilities.
Maintenance Task Checklist
Tasks Period
Sterilize all components that come into contact with the patient
Daily
and operator with an alcohol-based solution.
Wipe the outer covers of the equipment with a dry cloth at the
end of each day’s operation.
Do not use detergents or solvents to clean the Daily
outer covers of the equipment.
Ensure sure that the main power switch has been turned off
Daily
after using the equipment.
Ensure that the equipment is firmly plugged into a dedicated
Daily
power source.
Ensure there are no oil leaks. Daily
Ensure the wall framework is securely attached to the wall. Daily
Ensure that the plug and power cord are not hot. Daily

Tasks Period
Ensure the power supply cable is in good condition. Daily
Ensure the audible signal is audible and the x-ray emission
Daily
light is visible when you make an exposure.
Ensure that the orange (exposure) indicator light turns on when
Daily
the exposure switch is pressed.
Ensure that the power cable is not kinked, broken, exposed
Weekly
and that it is free of all other defects.
Ensure that all visible labels are intact and legible. Monthly
Ensure that the equipment is well grounded. Monthly
Ensure there is no wear or damage to the exposure switch
Monthly
cable.
Always turn off the equipment before performing any maintenance.

8. Service
8. Service
ENGLISH
VATECH requires periodic constancy tests to ensure image quality and the safety for
the patient and operator. Only VATECH authorized technicians can perform inspection
and service of this equipment. For the technical assistance, contact VATECH service
center or your local VATECH representative.

8. Service

9. Disposing of the Unit
ENGLISH
In order to reduce environmental contamination, this equipment is designed to be as
safe as possible to use and dispose of. Many components of this equipment are
environment-friendly and can be recycled.
All parts and components that contain hazardous materials must be disposed of in
accordance with disposal regulations. (IEC 60601-1 6.8.2 j)
Hazardous waste;
Waste
Part Material Recyclable Needs Separate
Disposal Site
Collection
Frame and Aluminum and
●
covers plastics
Power
●
Boards
Copper ●
Cables and
Steel ●
transformer
Oil ●
Polystyrene ●
Packing Cardboard ●
Paper ●
X-ray tube ●
Other parts ●
Please observe all regulations relevant to the disposal of waste in your

country.


10. Technical Specifications
ENGLISH
10.1 Mechanical Specifications
Dimensions: Wall-mounted Type

Horizontal arm (optional) Note 1 Note 4
450 mm (17.7”) 713 mm(28”) 2,003 mm(78.9”)
600 mm (23.6”) 863 mm(34”) 2,153 mm(84.8”)
900 mm (35.4”) 1,163 mm(45.8”) 2,453 mm(96.6”)
Item Description
Total 31.5 kg (69.4 Ib)
Tube Head 4.7 kg (10.4 Ib)
Weight Scissor arm 16.8 kg (37.0 lb)
Horizontal arm 4.0kg ( 8.8 lb)
Control Unit(With power

6.0kg (13.2 Ib)
box)
Round L=200 mm 60
Round L=300 mm 60
Beam limiting
Cone (Collimator) Rectangular L=200 mm FOV (cm) 2 x 3, 3 x 4
size
Rectangular L=300 mm FOV (cm) 2 x 3, 3 x 4
L = From the focal spot to edge of cone
SSD Standard cone 200 mm (8 inch)

(Source to Skin
Distance) Long cone 300 mm (12 inch)
Wall-mount for single stud

Type of installation
Wall-mount for 16”center stud installation unit mount

10.2 Technical Specifications
ENGLISH
X-Ray Generator: Type A (Toshiba)
Item Description
Model DG-10A05T3
Generator size Mono-tank : 140 x150 x 70
2.72 kg (Inverter: 0.92 / Monotank:
Weight
1.8)
Rated output power Max. 0.5 kW
Tube Voltage (kV) 50 - 70
Tube Current (mA) 4.0 – 7.0
sec 0.04 ~ 2
Kv Accuracy 5%
mA Accuracy 5%
High Voltage
Generator Automatically controlled / Protect ≥
Cooling 50℃
Air Cooling: Optional
Inherent Filtration At least 1.0 mm Al
Added Filtration 1.0 mm Al
Total Filtration Min 2.0 mm Al
Manufacturer Toshiba
Model D-041SB (Stationary Anode Type)
Focal spot size 0.4 mm (IEC60336)
X-ray Tube Target Angle 12.5 °
X- ray Coverage 70 mm at SID 200 mm
1:60 or more
Duty Cycle
(Exposure time: interval time)


ENGLISH
 Technique factors that constitute the maximum line current condition: 70 kV
/ 6 mA at 100 V~
 Maximum deviation of peak tube potential from indicated value: ± 10 %
 Maximum deviation of tube current from indicated value: ± 10 %
 Maximum deviation of exposure time from indicated value: ± 10 %
 The nominal X-ray voltage together with the highest X-ray tube current
obtainable from the high-voltage generator when operated at its nominal X-
ray tube voltage: 70 kV, 6 mA
 The highest X-ray tube current together with the highest X-ray tube voltage
obtainable from the high-voltage generator when operated at its highest X-
ray tube current: 6 mA, 70 kV
 The X-ray tube voltage and X-ray tube current which result in the highest
electric output power: 16.8 W (70 kV, 6 mA at 0.04 s of loading time) (P= 6 x
70000 x 0.04)
 The nominal electric power for a load time of 0.1s and at the nominal X-ray
tube voltage : 70kV, 6 mA – 42 W
 Nominal anode input power of the X-ray tube : 430 W
 Maximum anode heat content of the X-ray tube: 4.3 kJ
 Maximum anode Heat dissipation rate: 100 W

 Target material of the X-ray tube : Tungsten
 Target angle with respect to the reference axis : 12.5 ˚
 Values of loading factors concerning leakage radiation: 70 kV, 6 mA
 The lowest current time product or the combinations of loading factors

resulting in the lowest current time product : 50 kV, 4 mA, 0.04 s of loading
time
 Values of loading factors concerning leakage radiation : 70 kV, 6 mA
 Tolerances of the focal spot on the reference axis
X = ± 0.4 mm (sideways), Y = ± 0.4 mm (in depth), Z = ± 0.4 mm (in height)
 Reference axis to which the target angle and the focal spot characteristics
of the X-Ray tube refer

X-Ray Generator: Type B (C.E.I)
ENGLISH
Item Description
Model DG-10A05C3
Generator size, weight Monotank : 140 x150 x 70 / 2.5 kg
Rated output power MaX. 0.5 KW
Tube Voltage (kV) 50 ~ 70
Tube Current (mA) 4~7
Automatically controlled / Protect ≥ 50℃

Cooling
Air Cooling: Optional
Inherent Filtration 0.5 mm Al
Added Filtration 1.5 mm Al
Total Filtration Min 2.0 mm Al
Manufacturer C.E.I.
Model OX/70-4C (Stationary Anode Type)
Focal spot size 0.4 mm (IEC60336)
X-ray Tube
Target Angle 16 °
X- ray Coverage _
Duty Cycle _
Maximum Rating Charts

Emission and Filament Characteristics
Anode Thermal Characteristics

10.3 Electrical Specifications
ENGLISH
Item Description
Power supply voltage - AC 100 - 240 V
Frequency 50 / 60 Hz (Single phase)
Power rating Max.1.2 kVA
 The input line voltage depends on the local electrical distribution system.
 Allowable input voltage fluctuation requirement: ± 10 %.
10.4 Environmental Specifications
Item Description
Temperature 10 ~ 35
During operating Relative humidity 30 ~ 75 %
Atmospheric pressure 860 ~ 1060 hPa
Temperature -10 ~ +60

Transport and storage Relative humidity 10 ~ 75 % non-condensing
Atmospheric pressure 860 ~ 1060 hPa


11. X-Ray Dose Data
11. X-Ray Dose Data
ENGLISH
The X-ray dose data is extracted from the X-Ray Dose Test Report for the EzRay. The
X-ray doses of EzRay in the test report were measured in accordance with the IEC
collateral standards. EzRay was designed in accordance with Part 1. General
Requirements for Safety, IEC 60601-1-3.
Test Condition
Brand Name (Model) EzRay (VEX-S100W)
Tube type Toshiba D-041SB
Loading Factor 60 kV, 6.0 mA
Tube type / Inverter type DG-10AT3 / INV11
11.1 X-Ray Dose Table
Test Equipment
Instrument Manufacturer Model S/N
Dose Meter Piranha 255 CB2-08050121
Dose Table
t (s) Dose (mGy) t (s) Dose (mGy)
0.04 0.05 0.50 0.59
0.05 0.07 0.55 0.70
0.08 0.10 0.60 0.76
0.10 0.13 0.70 0.89
0.15 0.19 0.80 1.01
0.20 0.25 0.90 1.15
0.25 0.31 1.00 1.29
0.30 0.38 1.50 1.93
0.45 0.57 2.00 2.57

11. X-Ray Dose Data
11.2 Leakage Dose Test Report
Test Equipment Information
Instrument Manufacturer Model S/N
Dose Meter Victoreen 660 101114 / 101377
Test Condition
Distance from focal point [m] 1
Applied Tube Voltage Peak [kVp] 70
Applied Tube Current [mA] 6.0
Applied Exposure time [s] 0.5
Basic Cone [mR/hr]

Direction [°]
Transverse Longitudinal
0 0.2 6.9
45 1.6 4.5
90 5.5 6.1
135 1.2 6.4
180 0.4 10.8
225 1.2 6.4
270 6.2 7.0
315 8.0 5.8

11. X-Ray Dose Data
The tested area on the plane of radiation is defined within a radius at a distance of 1 m
from the focal spot.
ENGLISH
[Measurement Points (Transverse / Longitudinal)]
Beam Direction
[Measurement Values (Transverse)]

11. X-Ray Dose Data
[Measurement Values (Longitudinal)]

12. Electromagnetic Compatibility (EMC) Information
12. Electromagnetic Compatibility (EMC)
ENGLISH
Information
Guidance and manufacturer’s declaration - electromagnetic emissions.
The EzRay is intended for use in the electromagnetic environment specified below.
The customer or the user of the EzRay should assure that it is used in such an
environment.
Electromagnetic
Emissions test Compliance
environment - guidance
The EzRay uses RF energy
only for its internal function.
Therefore, its RF emissions
RF emissions CISPR 11 Group 1
are very low and are not likely
to cause any interference in
nearby electronic equipment.
Class A (The The EzRay must be used only
EzRay in in a shielded location with a
RF emissions CISPR 11 combination with minimum RF shielding
the shielded effectiveness and, for each
location) cable that exits in the shielded
area, a minimum RF filter
Harmonic emissions IEC attenuation of 20 dB from 30
Not applicable
61000-3-2 MHz to 230 MHz, 20 dB from
230 MHz to 1 GHz is
recommended. The EzRay,
when installed in such a
shielded location, is suitable
for use in all establishments
Voltage fluctuations / flicker and may be used in domestic
Not applicable establishments and those
emissions IEC 61000-3-3
directly connected to the
public low-voltage power
supply network that supplies
buildings used for domestic
purposes.
NOTE) It is essential that the actual RF shielding effectiveness and filter attenuation
of the shielded location be verified to ensure that they meet or exceed the specified
minimum values.

Guidance and manufacturer’s declaration - electromagnetic immunity
environment.
Immunity IEC 60601 Test Compliance Electromagnetic
test level level environment -guidance
Electrostatic ±6 kV Contact ±8 ±6 kV Contact ±8 Floors should be wood,
discharge kV air kV air concrete or ceramic tile.
(ESD) IEC If floors are covered with
61000-4-2 synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Main power quality
transient/burst supply lines ±1 kV supply lines ±1 should be that of a
IEC 61000-4- for input/output kV for typical commercial or
4 lines input/output lines hospital environment.
Surge IEC ±1 kV line(s) to ±1 kV line(s) to Main power quality

61000-4-5 line(s) ±2 kV line(s) ±2 kV should be that of a
line(s) to earth line(s) to earth typical commercial or
hospital environment.
Voltage dips, < 5 % Uт (> 95 % < 5 % Uт (> 95 % Main power quality
short dip in Uт) for dip in Uт) for should be that of a
interruptions 0.5cycle 40 % Uт 0.5cycle 40 % Uт typical commercial or
and voltage (60 % dip in Uт ) (60 % dip in Uт ) hospital environment. If
variations on for 5 cycle, 6 cycle for 5 cycle, 6 the user of the EzRay
power supply 70 % Uт (30 % dip cycle 70 % Uт image intensifier
input lines in Uт) for 25 cycle, (30 % dip in Uт) requires continued
IEC 61000-4- 30 cycle <5 % Uт for 25 cycle, 30 operation during power
11 (< 95 % dip in Uт ) cycle <5 % Uт (< mains interruptions, it is
for 5 s 95 % dip in Uт ) recommended that the
for 5 s EzRay be powered from
an uninterruptible power
supply.
Power 3 A/m 3 A/m Power frequency
frequency magnetic fields should
(50/60 Hz) be at levels
magnetic field characteristic of a typical
IEC 61000-4- location in a typical
8 commercial or hospital
environment.
NOTE Uт is the a.c. mains voltage prior to application of the test level.

ENGLISH
environment.
IEC 60601 Compliance Electromagnetic
Immunity test
Test level level environment -guidance
Electrostatic ±6 kV Contact ±6 kV Contact Floors should be wood,
discharge ±8 kV air ±8 kV air concrete or ceramic tile. If
(ESD) IEC floors are covered with
61000-4-2 synthetic material, the
relative humidity should be
at least 30 %.
Electrical fast ±2 kV for ±2 kV for power Main power quality should
transient/burst power supply supply lines ±1 be that of a typical
IEC 61000-4-4 lines ±1 kV for kV for commercial or hospital
input/output input/output lines environment.
lines
Surge IEC ±1 kV line(s) to ±1 kV line(s) to Main power quality should
61000-4-5 line(s) ±2 kV line(s) ±2 kV be that of a typical
line(s) to earth line(s) to earth commercial or hospital
environment.
Voltage dips, < 5 % Uт (> < 5 % Uт (> Main power quality should
short 95 % dip in Uт) 95 % dip in Uт) be that of a typical
interruptions for 0.5cycle for 0.5cycle commercial or hospital
and voltage 40 % Uт (60 % 40 % Uт (60 % environment. If the user of
variations on dip in Uт ) for 5 dip in Uт ) for 5 the EzRay image
power supply cycle, 6 cycle cycle, 6 cycle intensifier requires
input lines IEC 70 % Uт (30 % 70 % Uт (30 % continued operation during
61000-4-11 dip in Uт) for dip in Uт) for 25 power mains interruptions,
25 cycle, 30 cycle, 30 cycle it is recommended that the
cycle <5 % Uт <5 % Uт (< 95 % EzRay be powered from
(< 95 % dip in dip in Uт ) for 5 s an uninterruptible power
Uт ) for 5 s supply.
Power 3 A/m 3 A/m Power frequency magnetic
frequency fields should be at levels
(50/60 Hz) characteristic of a typical
magnetic field location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE Uт is the a.c. mains voltage prior to application of the test level.

electromagnetic environment.
Immunity IEC 60601 Compliance Electromagnetic environment -
test test level level guidance
Conducted 3 Vrms 150 3 Vrms 150 The EzRay must be used only in
RF IEC kHz to kHz to 80MHz a shielded location with a
61000-4-6 80MHz 3 V / 3 V / m 80 minimum RF shielding
Radiated RF m 80 MHz to MHz to effectiveness and, for each cable
IEC 61000-4- 2.5GHz 2.5GHz that exits the shielded location, a
3 minimum RF filter attenuation of
20 dB from 30 MHz to 230 MHz,
20 dB from 230 MHz to 1 GHz.
Field strengths outside the
shielded location from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than 3 V / m.a
Interference may occur in the
vicinity of equipment marked with
the following symbol:
NOTE 1) These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation
of the shielded location be verified to assure that they meet the minimum
specification.
Field strength from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength
outside the shielded location in which the EzRay is used exceeds 3V/m, the EzRay
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as relocating the EzRay or
using a shielded location with a higher RF shielding effectiveness and filter
attenuation.

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Notice

This document is originally written in English.

The EzRay is referred to as Equipment in this manual.

Manual Name: EzRay (Model: VEX-S100W) User Manual

Publication Date: 2013-9

Copyright © 2013 by VATECH

All rights reserved.

Manufactured by VATECH Co., Ltd.

EzRay User Manual v

Left blank intentionally

vi EzRay User Manual

Table of Contents ............................................................................................. vii

1. General and Regulatory Information................................................... 1

1.1 Manufacturer's Liability ..................................................................... 1

2. Safety Instructions .............................................................................. 5

2.1 General Safety Guidelines ................................................................. 5

3. The System Overview .......................................................................... 7

3.1 Indication for Use ............................................................................. 7

4. Preparations for Exposure ................................................................. 15

4.1 Turning the Equipment On .............................................................. 15

5. Using the System ............................................................................... 17

5.1 Exposure Parameters ...................................................................... 17

6. Emergency Measures ......................................................................... 27

7. Cleaning and Maintenance ................................................................ 31

9. Disposing of the Unit ......................................................................... 35

10. Technical Specifications .................................................................... 37

10.1 Mechanical Specifications ............................................................... 37

EzRay User Manual vii

11. X-Ray Dose Data ............................................................................... 47

11.1 X-Ray Dose Table ........................................................................... 47

12. Electromagnetic Compatibility (EMC) Information ........................... 51

viii EzRay User Manual

1. General and Regulatory Information

 The equipment has been installed by a VATECH authorized technician.

 All maintenance and repairs have been performed by a VATECH authorized

1.2 Owner and Operator's Obligations

EzRay User Manual 1

1.3 Conventions in this Manual

Indicates information that should be followed with the

Indicates a situation that demands prompt and

Indicates a situation or action that could potentially

Emphasizes important information or provides useful

2 EzRay User Manual

1.4 Marks and Symbols

Attention: consult accompanying documents

Protective earth (Ground)

Off (power: disconnect from the main switch)

On (power: connect to the main switch)

The CE symbol indicates that this product complies

UL mark : UL 60601-1 / CAN/CSA

Address where the equipment was manufactured

This symbol indicates that electrical and electronic

EzRay User Manual 3

1.5 Standards and Regulations

The EzRay 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 compliance with

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.

4 EzRay User Manual