User manual
User Manual
Model : VEX-P300
Version : 1.30
English
Postal Code: 18449
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea
www.vatech.co.kr
For the United Kingdom region
Notice
EzRay Air (Model: VEX-P300) User Manual v
Notice
The VEX-P300 is a portable dental X-ray system.
This manual contains descriptions, operational instructions, imaging procedures for the
VEX-P300 dental X-ray system. It is recommended that thoroughly familiarize yourself
with this manual in order to make the most effective use of this equipment. Observe all
cautions, safety messages and warnings that appear in this manual.
Keep this manual with the equipment at all times and review the operating procedures
and safety instructions if needed.
The illustrations/photos of the equipment in this manual are only for illustration
purposes. The actual equipment may differ.
Due to continuous technological improvements, the manual may not contain the most
updated information. For further information not covered in this manual, please contact
us at:
VATECH Co., Ltd.
Phone: (+82) 1588 9510
E-mail: gcs@vatech.co.kr
This document is originally written in English.
The VEX-P300 is referred to as Equipment in this manual.
Manual Name: EzRay Air (Model: VEX-P300) User Manual
Document number: VDH-UM-067
Version: 1.30
Publication Date: 2018-03
Notice
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Table of Contents
EzRay Air (Model: VEX-P300) User Manual vii
Table
of Contents
Notice ................................................................................................................. v
Table
of Contents ............................................................................................. vii
1. General and Regulatory Information................................................... 1
1.1 Manufacturer's Liability ..................................................................... 1
1.2 Owner and Operator's Obligations .................................................... 1
1.3 Conventions Used in this Manual ...................................................... 2
1.4 Marks and Symbols ......................................................................... 3
1.5 Standards and Regulations .............................................................. 7
2. Safety Instructions .............................................................................. 9
2.1 General Safety Guidelines ................................................................ 9
2.2 Warnings and Safety Instructions .................................................... 10
3. System Overview ............................................................................... 13
3.1 Indications for Use ......................................................................... 13
3.2 Principles of Operation ................................................................... 13
3.3 Intended User Profile ..................................................................... 13
3.4 Components .................................................................................. 14
3.5 Features ........................................................................................ 14
3.6 General View of the Equipment ....................................................... 15
4. Operation ........................................................................................... 19
4.1 Power On/Off ................................................................................. 19
4.2 Operation Mode ............................................................................. 21
4.3 Positioning .................................................................................... 23
4.4 Exposure ....................................................................................... 35
4.5 Using the Battery ........................................................................... 37
5. Service Mode ..................................................................................... 45
5.1 Overview ....................................................................................... 45
5.2 Changing System Parameters ........................................................ 46
5.3 Service Mode Menu ....................................................................... 49
6. Troubleshooting ................................................................................ 60
7. Cleaning and Maintenance ................................................................ 62
7.1 Cleaning ........................................................................................ 62
7.2 Maintenance .................................................................................. 63
8. Disposing of the Unit ......................................................................... 66
9. Equipment Specifications .................................................................. 68
Table of Contents
viii EzRay Air (Model: VEX-P300) User Manual
9.1 Mechanical Specifications .............................................................. 68
9.2 Technical Specifications ................................................................. 69
9.3 Electrical Specifications .................................................................. 74
9.4 Environmental Specifications .......................................................... 74
10. Appendix ........................................................................................... 76
10.1 Tables of Exposure Times (Default) ................................................. 76
10.2 X-ray Dose Data ............................................................................ 77
10.3 Electromagnetic Compatibility (EMC) Information ............................. 87
10.4 Abbreviations ................................................................................ 91
1. General and Regulatory Information
EzRay Air (Model: VEX-P300) User Manual 1
ENGLISH
1. General and Regulatory Information
1.1 Manufacturer's Liability
The manufacturers and/or retailers of this equipment assume responsibility for the safe
and normal operation of this equipment only when:
▪ Always use genuine VATECH approved equipment and parts.
▪ Perform all maintenance and repairs at a VATECH authorized distributor.
▪ Using this equipment properly according to the user manual.
▪ The equipment damage or malfunction is not the result of an error on the part of
the owner or operator.
Disclaimer:
EzRay Air is sold with the understanding that the user assumes sole
responsibility for radiation safety (as well as any state, provincial, or
local regulatory compliance) and that VATECH, its agents or
representatives, do not accept responsibility for:
1) any injury or danger to personnel from X-ray exposure,
2) image over/underexposure due to poor operating techniques or
procedures,
3) equipment which has been damaged, modified, or tampered with
in any way.
1.2 Owner and Operator's Obligations
▪ The owner of this equipment must perform constancy tests at regular intervals
Eto ensure patient and operator safety. These tests must be performed in
accordance with local X-ray safety regulations.
▪ The owner of this equipment must perform regular inspection and maintenance of
the mechanical and electrical components in this equipment to ensure safe and
consistent operation (IEC 60601-1).
▪ The owner of this equipment must ensure inspection and cleaning work is
performed in accordance with the maintenance schedule outlined in Chapter 7
Cleaning and Maintenance.
DO NOT operate this equipment until reading this manual and reviewed
the related materials.
1. General and Regulatory Information
2 EzRay Air (Model: VEX-P300) User Manual
1.3 Conventions Used in this Manual
The following symbols are used throughout this manual. Make sure that fully
understand each symbol and follow the instructions which accompany it.
To prevent personal injury and/or damage to the equipment, please observe all
warnings and safety information included in this document.
WARNING
Indicates that a specific hazard is known to exist
which through inappropriate conditions or actions
may cause:
Severe personal injury (to the operator and/or
patient)
Substantial property damage.
RADIATION
HAZARD
Indicates a possible danger from exposure to
radiation.
CAUTION
Indicates that a potential hazard may exist which
through inappropriate conditions or actions will or
can cause:
Minor injury
Property damage.
IMPORTANT
Indicates that a potential problem may exist which
through inappropriate conditions or actions can
cause:
Property damage.
NOTE
Indicates precautions or recommendations that
should be used in the operation of the system,
specifically:
Using this Manual
Notes to emphasize or clarify a point.
1. General and Regulatory Information
EzRay Air (Model: VEX-P300) User Manual 3
ENGLISH
1.4 Marks and Symbols
The following table describes the purpose and location of safety symbols and other
important information provided on the equipment.
Mark/Symbol
Description
Location
Alternate current
Battery
Charger Label
Direct current
Main Label
Attention:
Consult accompanying documents
Main Label
Dangerous voltage
Power board,
X-ray
Generator,
Generator
Label
Off (power: disconnect from the main
switch)
Battery bay
access door
(outside)
On (power: connect to the main switch)
Battery bay
access door
(outside)
IEC60601-1
Degree of Protection from Electric Shock
TYPE B Equipment
Main Label
Radiation hazard
Generator
Label
Authorized European Representative
address
Main Label
The CE symbol indicates that this
equipment complies with the European
Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb
device.
Main Label
CSA mark
No.266436
Main Label
1. General and Regulatory Information
4 EzRay Air (Model: VEX-P300) User Manual
Mark/Symbol
Description
Location
Caution: Federal law restricts this device to
sale by or about a licensed healthcare
practitioner.
Main Label
Manufacturer’s name and address
Main Label,
Generator
Label
Date of manufacture
Main Label,
Generator
Label
This symbol indicates that electrical and
electronic equipment must not be disposed
of as unsorted municipal waste and must
be collected separately.
Main Label
ESD susceptibility symbols indicate that an
item is susceptible to damage from
electrostatic discharges.
Board
package
Refer to the User Manual.
Main Label
Using a Torx wrench, unscrew the battery
bay access door.
Main Label
Lift the door after removal of the screw.
Main Label
Battery replacement procedure
Battery bay
access door
(inside)
This symbol indicates the direction of cover
attachment/detachment.
Cone’s upper
part
1. General and Regulatory Information
EzRay Air (Model: VEX-P300) User Manual 5
ENGLISH
1.4.1 Label Locations
1. Generator Label
2. Main Label
1
2
4
3
1. General and Regulatory Information
6 EzRay Air (Model: VEX-P300) User Manual
3. UDI Label
The labels in this manual are only for illustration purposes. Actual labels
may differ.
1. General and Regulatory Information
EzRay Air (Model: VEX-P300) User Manual 7
ENGLISH
1.5 Standards and Regulations
Standards:
The VEX-P300 is designed and manufactured to meet the following standards:
▪ IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-65
▪ X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY VEX-P300
IEC 60601-2-65:2012
▪ CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1-3:09,
CAN/CSA-C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-2-65:15,
CAN/CSA-IEC 62366:14
▪ ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, C1:2009 / (R)2012 AND
A2:2010 / (R)2012 (Consolidated text - edition 3.1)
▪ ISO 13485
▪ 21 CFR 1020.30 & 1020.31
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment (IPX0)
Protection against electric shock: Class I equipment, Type B Applied Parts: Conehead
The CE symbol grants this equipment complies with the
European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb device.
1. General and Regulatory Information
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2. Safety Instructions
EzRay Air (Model: VEX-P300) User Manual 9
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2. Safety Instructions
2.1 General Safety Guidelines
This equipment is designed and manufactured to ensure the greatest
safety of operation. Operate and maintain it in strict compliance with
the safety precautions and operating instructions contained in this
manual.
This equipment must be operated only by legally qualified persons.
Observe all local fire regulations. Always keep a fire extinguisher
near the equipment.
The equipment must be installed, maintained, and serviced by
qualified service personnel according to the procedures and
preventive maintenance schedules. Only battery replacement can be
performed by users.
Ensure that the on/off switch is set to off when the equipment is not
in use.
Always disconnect the power supply before cleaning the equipment.
DO NOT keep the equipment or its parts in a humid place or a liquid
substance.
Avoid placing the equipment near chemical storage and gas-filled
storage facilities.
The backscatter shield protects users from backscatter radiation that
they might be exposed during X-ray exposure. Operating the
equipment with the backscatter shield allows the users to be
exposed to less radiation compared to when operating without. For
details on the scatter data of the device configured both with and
without the backscatter shield, please review ‘10.2.3 Scattered
Dose’.
This equipment is shipped with the backscatter shield attached (firmly
fixed), so the backscatter shield cannot be replaced by users. If it is
damaged or defective, contact your Service Representative for
replacement.
Mode of operation: Continuous operation with intermittent loading—This
equipment needs a rest time of at least 30 times the exposure time
before starting the next exposure.
2. Safety Instructions
10 EzRay Air (Model: VEX-P300) User Manual
2.2 Warnings and Safety Instructions
This X-ray unit may be dangerous to patient and operator unless
safe exposure factors, operating instructions, and maintenance
schedules are observed.
It is important to read this user manual carefully and strictly abide by
all warnings and cautions stated within it.
To avoid the risk of electric shock, this equipment must only be
connected to a supply main with protective earth.
Since rules and regulations concerning radiation safety differ
between countries, it is the responsibility of the owner and/or
operator of this equipment to comply with all applicable rules and
regulations concerning radiation safety and protection in their area.
DO NOT open or remove the cover panels on this equipment.
Never expose this equipment to liquids, mists or sprays. Exposing
this equipment to liquids may cause an electrical shock or otherwise
damage the system.
DO NOT use spray cleaners on this equipment, as this could cause
a fire.
Never use this equipment in an environment that is susceptible to
explosion.
DO NOT place flammable materials near this equipment.
Never touch the patient while also touching the SIP/SOP
connectors.
Medical electrical equipment is subject to special EMC preventive
measures. For more details, refer to ‘10.3 Electromagnetic
Compatibility (EMC) Information’.
Patients and operators are encouraged to wear leaded protective
lead-lined aprons unless other Radiation Protection Protocols are
applied locally.
Children and pregnant women must consult with a doctor before X-
ray exposure.
Never try to modify this equipment, including the wires or cables.
Modifying this equipment may damage it beyond repair.
Serious dangers may occur from electromagnetic interference (i.e.
noise) between other equipment in the area during specific
examinations or medical treatment.
Battery chargers must be located in the accessible area where they
can be easily unplugged from the power source.
2. Safety Instructions
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ENGLISH
Battery Use
Make sure to charge the battery in the external environment from
the patient.
Make sure to use the battery only provided or approved by
VATECH. If non-standard or damaged batteries are used, there is a
risk of fire and explosion.
Make sure to use the battery charger only provided or approved by
VATECH. Using an unauthorized charger may result in battery
damage.
DO NOT expose batteries to heat or fire. Avoid storage in direct
sunlight.
DO NOT short-circuit, crush, puncture, mutilate, or disassemble the
battery.
DO NOT store batteries haphazardly in a box or drawer where they
may short-circuit each other or be short-circuited by other metal
objects.
Observe the plus (+) and minus (-) marks on the battery and
equipment and ensure correct use.
DO NOT subject batteries to mechanical shock.
In the event of a cell leaking, do not allow the liquid to come in
contact with the skin or eyes. If the contact has been made, wash
the affected area with copious amounts of water and seek medical
advice.
Keep the battery away from children and pets.
DO NOT make the battery wet or let it be in the water. Keep
batteries clean and dry.
Seek medical advice immediately if a battery has been swallowed.
Make sure to turn off the device before replacing the battery.
DO NOT remove a battery from its original packaging until required
for use.
DO NOT dispose of batteries with ordinary trash. Turn in discharged
batteries to local supply or discard or recycle batteries according to
your local government regulations.
DO NOT leave a battery on prolonged charge when not in use.
If the equipment has not been used for long periods of time, it is
recommended to charge the battery before use.
After extended periods of storage, it may be necessary to charge
and discharge the cells or batteries several times to obtain
maximum performance.
If the equipment not in use has been turned on for long periods of time,
the battery may be fully discharged.
- Depending upon the battery discharge status, it takes about 1 day
for charging the battery. If the device is not turned on after charging
2. Safety Instructions
12 EzRay Air (Model: VEX-P300) User Manual
the battery for about 1 day, it indicates that the battery has been fully
discharged. Contact your Service Representative for battery
replacement.
- DO NOT charge a fully discharged battery, as this may cause fire
or explosion. Be sure to replace the battery (provided by VATECH).
Batteries can be replaced by users.
When charging the battery, the exposure function is locked.
Be sure to turn off the equipment when not in use. This helps to
ensure the life of the battery.
Be sure to charge the battery frequently. This helps to ensure the life
of the battery.
Radiation Safety
This equipment must be operated only by properly trained, fully
qualified personnel in a controlled environment.
When using the equipment, it is recommended that all users comply
with the following radiation safety guidelines for the safety of the
users and the patients.
All users and patients should wear protective equipment, such as a
lead apron, thyroid collar, etc.
This equipment should be operated in the area that is more than 6
feet away from other personnel, such as assistants or other patients.
If they should stay closer than 6 feet, it is recommended that they
wear a lead apron, thyroid collar, or stay behind a lead shield.
Pregnant women should not be exposed to X-rays unless it is strictly
necessary.
All users should comply with the Radiation Protection Policies
established by the government.
When selecting a Position Indicating Device, it should be considered
if the PID can be used with the backscatter shield attached at the
outer end of the cone for most operator protection.
3. System Overview
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ENGLISH
3. System Overview
The VEX-P300, a portable dental X-ray system, operates on 22.2 V d.c. supplied by a
rechargeable Li-ion polymer battery pack. The portable X-ray system is an X-ray
generating device which is mainly designed for dental examination (teeth and jaw).
The portable X-ray system is composed of an X-ray generating part with an X-ray tube
including a device controller, a power controller, a user interface, a beam limiting part,
a backscatter shield, and an optional Remote Exposure Switch. The VEX-P300 is
designed to diagnose teeth and jaw through X-ray exposure using intra-oral image
receptors.
3.1 Indications for Use
The VEX-P300 is a portable dental X-ray 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 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.
3. System Overview
14 EzRay Air (Model: VEX-P300) User Manual
3.4 Components
No.
Item
Standard
Option
Qty.
1
VEX-P300 Main Body
● 1
2
Battery Charger (power cord
included)
● 1
3
User Manual
● 1
4
Backscatter Shield
● 1
5
Round Cover
● 1
6
Cradle
● 1
7
Rectangular Cover (2x3)
● 1 8 Rectangular Cover (4x3)
● 1
9
Remote Exposure Switch
● 1
10
Base Holder
● 1
11
Hand/Neck Strap
● 1
3.5 Features
The VEX-P300 is an intra-oral portable X-ray system that offers safety, reliability, and
greater functionality:
▪ Lightweight and ergonomic design
▪ The convenience of cordless design by using battery-pack
▪ Micro-computer and a specialized circuit that monitors and precisely regulates the
exposure technique factors (kV, mA, and exposure time)
▪ Pre-programmed exposure time makes the operation fast and easy.
3. System Overview
EzRay Air (Model: VEX-P300) User Manual 15
ENGLISH
3.6 General View of the Equipment
Main Body
No.
Item
Description
1
Backscatter Shield
Shields from the backscattering radiation.
2
X-ray Beam Limiting
Device
Limits the X-ray exposure area.
Default type: Round Cone + Round Cover (FOV: Ø 6
cm)
3
X-ray Exposure
Button
Press the button for X-ray exposure.
4
Handle
Grip the handle securely when using the system.
5
Power Button
Power On/Off button
6
Battery
Rechargeable Lithium-ion battery
7
Adaptor Connector
Connect the charging adaptor.
8
Remote X-ray
Exposure Switch Port
Connect the X-ray exposure cable switch.
Or can be used as a service port
9
Strap Loop
Connect the strap.
10
Control Panel
Display for the X-ray exposure settings and
operation conditions
3. System Overview
16 EzRay Air (Model: VEX-P300) User Manual
No.
Item
Description
11
X-ray Generator
Includes the X-ray tube and the high-voltage
generator.
3. System Overview
EzRay Air (Model: VEX-P300) User Manual 17
ENGLISH
Control Panel
No.
Item
Description
1
Tube
Voltage/Current
Indicator
Indicates the tube voltage and tube
current of the system.
2
Angle/Time
Display
Displays the X-ray exposure time, error
code, cooling time and exposure angle.
3
Adult/Child
Selection
Indicates a patient type (adult or child).
4
Remaining
Battery
Indicator
Indicates remaining battery level.
Battery
Charging
Indicator
1) Indicates the battery charger is
connected to the device.
2) Indicates the battery needs to be
charged when it flickers.
5 SET Button
Resets the X-ray exposure angle.
6 Speaker
Sound alarm for the X-ray exposure
7
Tooth Type
Selection
Selects the tooth type.
1 2 3 4 5 6 7 8 9
10
3. System Overview
18 EzRay Air (Model: VEX-P300) User Manual
No.
Item
Description
8
X-ray Exposure
Indicator
Indicates the X-ray exposure status.
(Green: Ready / Yellow: X-ray On)
9 Jog Dial
Turn the jog dial left (-) or right (+) to
select an X-ray exposure setting, press
the jog dial to confirm the operating
setting.
10 AUTO Button
Available only in countries allowing auto
mode use.
This button is not available in the United
Kingdom. When this button is pressed,
only "NA" is displayed in the display.
Available Option Items
No.
Figure
Option name
1
Rectangular Cover 2x3 (3x2)
FOV: 2x3 cm, 3x2 cm
(This cover can be used as both
2x3 and 3x2.)
2 Remote Exposure Switch
3
Base Holder*
* In case a tripod is used with the Base Holder, refer to the specifications below.
Fixing bolt size: 3/8 inch
Maximum supportable weight: about 5 kg
Minimum height: > 130 cm
More than 3 columns are required.
When using a tripod with 3 columns, make sure to have space of at least 1 min width on
the bottom.
4. Operation
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4. Operation
4.1 Power On/Off
1. Turn on the system referring to the following figure.
2. The following displays and indicators light up:
▪ Current Angle/Time display
▪ Tooth type selection display
▪ Adult/Child selection display
▪ Remaining battery indicator
▪ X-ray exposure indicator
3. Make sure that at least one battery indicator light comes on.
Battery level 1
ON
OFF
4. Operation
20 EzRay Air (Model: VEX-P300) User Manual
When the battery indicator has one flickering light, charge the battery immediately by
using the battery charger.
For more information, refer to ‘4.5 Remote Exposure Switch
The Remote Exposure Switch allows the operator to control image acquisition from
outside of the X-ray room.
Press and hold the Remote Exposure Switch until the acquisition is
completed. Premature release of the Remote Exposure Switch will abort
image acquisition.
Pressing the Remote Exposure Switch activates the X-ray Exposure
Indicator to turn yellow. This color indicates that the X-ray is being emitted.
The Remote Exposure Switch is detachable. Ensure that the
Remote Exposure Switch cable is not detached out from the unit
accidentally during the operation.
Keep vocal/visual contact with the patient during exposure. If any
problem occurs during exposure, release the Remote Exposure
Switch immediately.
Using the Battery
4. Operation
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ENGLISH
4.2 Operation Mode
This system can be operated in Manual Mode.
Manual Mode
1. When the tooth type selection area flickers, turn the jog dial to select the tooth
type. To see the Control Panel before and after selection, refer to the figures
below.
Before tooth type selection After tooth type selection
Tooth Type
Symbol
Type
Incisor
Canine
Molar/Premolar
Bitewing
4. Operation
22 EzRay Air (Model: VEX-P300) User Manual
2. After tooth type selection, a patient type should be selected. When the Adult/Child
selection area flickers, turn the jog dial to select the patient type. To see the
Control Panel after selection, refer to the figure below.
After patient type selection
Patient Type
Symbol
Type
Adult
Child
After the tooth type and patient type are selected, the exposure time is
automatically displayed.
3. When changing the exposure time, turn the jog dial to adjust the exposure time
from 0.05 to 0.5 s. (increments: 0.01 s)
When pressing the jog dial after adjusting the exposure time in Manual
Mode, the exposure time is returned to the default setting.
To save the exposure time as default in Manual Mode, press and hold
the jog dial for about 3 seconds.
4. Operation
EzRay Air (Model: VEX-P300) User Manual 23
ENGLISH
4.3 Positioning
Positioning the Patient
To obtain high-quality intra-oral radiography with maximum details, take extra care in
all steps of the radiography process: positioning the patient and the X-ray imaging
system; exposing the intra-oral sensor.
1. Place a protective lead apron on the patient’s chest.
2. 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.
Frankfort plane
Occlusal plane
4. Operation
24 EzRay Air (Model: VEX-P300) User Manual
3. Place the tube head cone in the area want to take an image.
When holding the device, it is recommended to grip the handle by one hand and
place the other on the underside of the Exposure Button and the cone as shown
in the following figure.
Depending on the imaging angles, exposure times vary. Since it is
necessary to keep the patient with low X-ray doses and the user in the
protected area, have the patient’s head slightly tilted, and raise or
lower the chin if needed. Please refer to ‘2.2 Warnings and Safety
Instructions’.
For further information about the patient positioning and beam angle for each mode,
refer to the following Positioning Instructions.
4. Operation
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ENGLISH
Positioning Instructions
Paralleling technique: The sensor is placed in a holder which is used to align the
sensor parallel to the long axis of the teeth.
Bisected angle technique: The patient holds the sensor in place with his/her finger.
The X-ray beam is directed perpendicularly towards an imaginary line, which bisects
the angle between the sensor plane and the long axis of the tooth.
Position the tube head to the patient using the accepted standard positioning
procedures.
1. Sensor
2. Long axis of the tooth
1. Sensor
2. Long axis of the tooth
4. Operation
26 EzRay Air (Model: VEX-P300) User Manual
Here are the specific angulations and directions for the tube head in order to take the
best images of a particular tooth (i.e. Bisected angle technique).
Position the receptor carefully not to damage the soft tissue of the
patient’s intra-oral area.
▪ Maxillary Incisor
The x-ray beam is directed downward at 45°.
Teeth
Angle of inclination
Incisor
Maxilla
+45˚
4. Operation
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ENGLISH
▪ Mandibular Incisor
The x-ray beam is directed upward at 25°.
Teeth
Angle of inclination
Incisor
Mandible
-25˚
4. Operation
28 EzRay Air (Model: VEX-P300) User Manual
▪ Maxillary Canine
The x-ray beam is directed downward at 45°.
Teeth
Angle of inclination
Canine
Maxilla
+45˚
4. Operation
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ENGLISH
▪ Mandibular Canine
The x-ray beam is directed upward at 20°.
Teeth
Angle of inclination
Canine
Mandible
-20˚
4. Operation
30 EzRay Air (Model: VEX-P300) User Manual
▪ Maxillary Molar and Premolar
The x-ray beam is directed downward at 30°.
Teeth
Angle of inclination
Molar and Premolar
Maxilla
+30˚
4. Operation
EzRay Air (Model: VEX-P300) User Manual 31
ENGLISH
▪ Mandibular Molar and Premolar
The x-ray beam is directed upward at 5°.
Teeth
Angle of inclination
Molar and Premolar
Mandible
-5˚
4. Operation
32 EzRay Air (Model: VEX-P300) User Manual
▪ Bitewing
For a bitewing exposure, the patient closes their teeth during exposure on the
sensor holder.
The x-ray beam is directed downward at 5° ~ 8°.
Teeth
Angle of inclination
Bitewing exposure
+5˚~ +8˚
4. Operation
EzRay Air (Model: VEX-P300) User Manual 33
ENGLISH
Positioning the Imaging Sensor
To ensure image quality, the digital imaging sensor must be positioned properly (for
information about the proper placement of the imaging sensor, please refer to
‘Positioning Instructions’ on page 25.
▪ Failure to position the imaging sensor properly can result in errors on the
radiograph, such as distorted teeth and roots, elongation, magnification, and
overlapping contacts.
The paralleling technique generally reduces the risk of such errors, but
if position the sensor improperly, angulation errors may occur
(angulation of the sensor to the tooth itself).
▪ Failure to align the imaging sensor with the exit pattern of the X-ray beam can
result in cone-cuts on the radiograph. The cone-cuts are clear areas that are
shown on the radiograph when part of the radiograph is not exposed to radiation.
Please refer to the following figure as an example of cone-cuts.
The following figure indicates how the cone-cut occurred by showing the position of the
imaging sensor and the radiation area.
Cone-cut
Cone-cut
Position of the sensor
Radiation area
4. Operation
34 EzRay Air (Model: VEX-P300) User Manual
To ensure proper alignment between the imaging sensor and the X-ray beam, it is
recommended to use a PID (Position Indicating Device) as shown in the following
figure.
When using the PID, the exit pattern of the X-ray device should be aligned
perpendicular to the target receptor as shown in the following figure.
Once the PID is properly aligned, instruct the patient not to move.
PID
4. Operation
EzRay Air (Model: VEX-P300) User Manual 35
ENGLISH
4.4 Exposure
The operator MUST instruct the patient to refrain from moving during
the entire exposure.
1. Instruct the patient not to move.
2. Press the Exposure Button for exposure duration.
3. While X-ray is being exposed,
▪ The X-ray Exposure Indicator lights up and an audible sound is produced.
▪ Keep pressing until the X-ray Exposure Indicator light goes out and the
audible sound stops.
Green: Ready
Yellow: X-ray On
Hold the Exposure Button or switch as long as the acoustic signal can
be heard. Otherwise, the exposure will be faulty and there will be an
error message on the Control Panel.
4. Operation
36 EzRay Air (Model: VEX-P300) User Manual
4.4.1 Remote Exposure Switch
The Remote Exposure Switch allows the operator to control image acquisition from
outside of the X-ray room.
Press and hold the Remote Exposure Switch until the acquisition is completed.
Premature release of the Remote Exposure Switch will abort image acquisition.
Pressing the Remote Exposure Switch activates the X-ray Exposure Indicator to turn
yellow. This color indicates that the X-ray is being emitted.
The Remote Exposure Switch is detachable. Ensure that the
Remote Exposure Switch cable is not detached out from the unit
accidentally during the operation.
Keep vocal/visual contact with the patient during exposure. If any
problem occurs during exposure, release the Remote Exposure
Switch immediately.
4. Operation
EzRay Air (Model: VEX-P300) User Manual 37
ENGLISH
4.5 Using the Battery
Battery level indicator with a residual quantity is shown on the left side
of the Control Panel. When the battery indicator has one flickering light
(level 1), charge the battery immediately. Refer to the battery levels as
shown below.
Level 3 Level 2 Level 1
If the battery is not charged for about an hour, the battery voltage
becomes low. At this level, all displays are turned off except for the
error code A.10 as shown in the following figure, so exposure cannot
be performed. After the device is connected to the battery charger, and
the battery level becomes ‘Level 1’, all functions are returned to
normal operation.
4. Operation
38 EzRay Air (Model: VEX-P300) User Manual
System Status depending on Battery Levels
Item
System Status
Battery
Level 3, 2
Battery Level 1
Low Battery
When
turning on
the system
Operation
Normal
Normal
Normal
Not operated
Battery
Level
Indicator
Normal
Normal
Flickers
Not displayed
Battery
Charging
Indicator
Not
displayed
Not
displayed
Flickers
Not displayed
Control
Panel
Brightness
Normal
Normal
Dark
Normal
(Error code A.10
is only
displayed)
When
operating
the system
Operation
Normal
Normal
Normal
Not operated
Battery
Level
Indicator
Normal
Normal
Flickers
Not displayed
Battery
Charging
Indicator
Not
displayed
Not
displayed
Flickers
Not displayed
Control
Panel
Brightness
Normal
Normal
Normal
Normal
(Error code A.10
is only
displayed)
Make sure to charge the battery if the Battery Charging Indicator flickers
(or the error code A.10 is displayed). If the device has been turned on
for long periods of time with the error code A.10, the battery may be
discharged.
DO NOT charge a fully discharged battery, as this may cause fire or
explosion. Be sure to replace the battery (provided by VATECH).
When the device is connected to the battery charger, the Battery
Charging Indicator is displayed at all times except that the battery is
fully discharged.
4. Operation
EzRay Air (Model: VEX-P300) User Manual 39
ENGLISH
Charging the Battery
1. Connect the battery charger to the battery charger connector as shown in the
following figure.
2. When the battery charger is connected, the battery charging LED indicator light
comes on. Charge the battery until all the three LED indicators are filled up.
Usually, it takes about 3 hours to fully charge the battery after a
complete discharge.
3. When the battery charge is completed, remove the battery charger from the
device.
It is not able to perform an exposure while the battery charger is
connected to the device.
Battery Use Cycle
The battery is a consumable part. It is expected to degrade gradually, so it should be
recharged more frequently. When the battery duration decreases to half or less than
half compared to when the battery was new, contact your Service Representative to
get a new battery.
To check how to replace the battery, see ‘Battery Replacement’ on page 40.
4. Operation
40 EzRay Air (Model: VEX-P300) User Manual
Battery Replacement
Batteries can be replaced by users.
To replace the battery, contact your Service Representative to get a
battery kit (including a new battery and a Torx wrench).
1. Manpower
One person, 3 minutes
2. Tools required
Torx wrench (size: T20)
3. Removal Procedure
1) Using a Torx wrench, unscrew the battery bay access door.
2) Lift the door and remove the battery.
4. Operation
EzRay Air (Model: VEX-P300) User Manual 41
ENGLISH
3) Disconnect the battery cable from the device by pressing the battery cable
connector as shown in the following figure.
DO NOT pull excessively on the battery cable.
4) Install the new battery in the reverse order of removal.
Press and disconnect the battery
cable connector
Battery cable connector
After disconnecting the battery cable
4. Operation
42 EzRay Air (Model: VEX-P300) User Manual
Sleep Mode
To reduce battery consumption, the Sleep Mode is started when the system is not in
use for one minute. (To see how to change the default waiting time for the Sleep Mode,
see ‘Waiting Time Setting for the Sleep Mode’ on page 53.)
1. When the Sleep Mode is started, the Control Panel becomes dark as shown in
the following figure (right).
Brightness: Normal Brightness: Dark
2. To return to normal operation, move the system or press any button (except for
the X-ray Exposure Button).
3. When not using the system, turn off the system to reduce battery consumption.
4. Operation
EzRay Air (Model: VEX-P300) User Manual 43
ENGLISH
Power Off Mode
If the system (not in use) has been turned on for 30 minutes since the Sleep Mode was
started, the Power Off Mode is started.
1. ‘Off’ is flickering on the Control Panel. When need to be notified by an alarm when
the Power Off Mode is started, change the setting referring to ‘Buzzer On/Off’ on
page 56.
2. To return to normal operation, move the system or press any button (except for
the X-ray Exposure Button).
3. When not using the system, turn off the system to reduce battery consumption.
If Password is enabled, must enter Password when switching from
Power Off Mode to Normal Mode.
4. Operation
44 EzRay Air (Model: VEX-P300) User Manual
Power Save Mode
If the system (not in use) has been turned on for 4 hours since the Power Off Mode
was started, the Power Save Mode is started.
1. All displays are turned off on the Control Panel.
2. To return to normal operation in the Power Save Mode, MUST turn off the system
and turn it back on.
5. Service Mode
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5. Service Mode
5.1 Overview
In the Service Mode, the following settings are able to check and changed.
▪ Factory Default Settings (See ‘5.3.1 Factory Default Settings’ on page 49.)
▪ Exposure Time Settings (for each patient and tooth type) (See ‘5.3.2 Exposure
Time Settings (for each patient and tooth type)‘ on page 50.)
▪ User Default Settings (for each patient and tooth type) (See ‘5.3.3 User Default
Settings (for each patient and tooth type)’ on page 51.)
▪ Password Mode On/Off (See ‘5.3.4 Password Mode On/Off’ on page 52.)
▪ Angle Increments Setting (See ‘1.1.1 ’ on page 53.)
▪ Waiting Time Setting for the Sleep Mode (See ‘5.3.5 Waiting Time Setting for the
Sleep Mode’ on page 53.)
▪ Waiting Time Setting for the Power Off Mode (See ‘5.3.6 Waiting Time Setting for
the Power Off Mode’ on page 54.)
▪ Waiting Time Setting for the Power Save Mode (See ‘5.3.7 Waiting Time Setting
for the Power Save Mode’ on page 55.)
▪ Buzzer On/Off (See ‘5.3.8 Buzzer On/Off’ on page 56.)
▪ Power Off Mode On/Off (See ‘5.3.9 Power Off Mode On/Off’ on page 58.)
▪ Password Setting (See ‘5.3.10 Password Setting’ on page 59.)
5. Service Mode
46 EzRay Air (Model: VEX-P300) User Manual
5.2 Changing System Parameters
To change system parameters:
1. Press and hold the SET button and jog dial at the same time (for about 3
seconds).
5. Service Mode
EzRay Air (Model: VEX-P300) User Manual 47
ENGLISH
2. Enter the 3 digits numeric password using the jog dial. (default password: 000)
3. Press the jog dial to enter the next digit then press and hold the jog dial.
5. Service Mode
48 EzRay Air (Model: VEX-P300) User Manual
4. After entering the password is completed, the Service Mode is started as shown
in the following figure.
5. There are a total of 10 modes. To select the first mode, press AUTO button as
shown on the left, then the Service Mode number n.01 is displayed on the Control
Panel as shown on the right.
6. Turn the jog dial to select the Service Mode number that has information to
change. To see the functions of each Service Mode menu, refer to ‘5.3 Service
Mode Menu’ on page 49.
7. To save the changes, press and hold the jog dial for about 3 seconds.
8. After saving the changes, press and hold the SET button and jog dial at the
same time (for about 3 seconds) to return to radiography.
5. Service Mode
EzRay Air (Model: VEX-P300) User Manual 49
ENGLISH
5.3 Service Mode Menu
Perform the Service Modes described in this section referring to ‘5.2 Changing System
Parameters’ on page 46.
5.3.1 Factory Default Settings
Perform this mode to restore the system to the factory default settings (it initializes all
the parameters except for n.24).
Service
Mode No.
Item
n.01
Factory default settings
To restore the system to the factory default settings,
1. Select n.01 by pressing the jog dial, then “YES” is displayed on the Control
Panel. It restores the system to the factory default.
2. Save the setting, and check if the system is restored to the factory default.
5. Service Mode
50 EzRay Air (Model: VEX-P300) User Manual
5.3.2 Exposure Time Settings (for each patient and tooth type)
Perform each mode to set the exposure time for each patient and tooth type referring
to the table below.
Service
Mode No.
Item
n.02
Adult Incisor
n.03
Adult Canine
n.04
Adult Molar/ Premolar
n.05
Adult Bitewing
n.06
Child Incisor
n.07
Child Canine
n.08
Child Molar/ Premolar
n.09
Child Bitewing
To set the exposure time for a specific patient and tooth type as described above,
1. Select the Service Mode number according to the patient and tooth type to take
an image. (i.e. n.06 for Child Incisor)
2. After entering the mode, turn the jog dial to adjust the exposure time.
3. Save the exposure time, and check if it has been correctly saved.
5. Service Mode
EzRay Air (Model: VEX-P300) User Manual 51
ENGLISH
5.3.3 User Default Settings (for each patient and tooth type)
Perform each mode to set the default settings for a specific patient and a tooth type
referring to the table below.
Service
Mode No.
Item
n.10
Adult
n.11
Child
n.12
Incisor
n.13
Canine
n.14
Molar/Premolar
n.15
Bitewing
To set the default setting for a specific patient type and a tooth type,
1. Select the Service Mode number between n.10 (Adult) and n.11 (Child) for a
specific patient type, and from n.12 to n.15 for a tooth type. For instance, When
select n.10 by pressing the jog dial to set the patient type ‘adult’ as default, then
“YES” is displayed on the Control Panel.
2. Save the setting, and check if the patient type ‘adult’ has been saved as default.
3. When performing other settings, follow the same procedure.
5. Service Mode
52 EzRay Air (Model: VEX-P300) User Manual
5.3.4 Password Mode On/Off
Perform this mode to turn on/off the password mode.
Service
Mode No.
Item
n.16
Password On
n.17
Password Off
To turn on the password mode,
1. Select n.16 by pressing the jog dial, then “YES” is displayed on the Control
Panel.
2. Save the setting, and check if the system requires a password when turning on
the system.
To turn off the password mode, select n.17 and follow the same procedure as
described above.
5. Service Mode
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ENGLISH
5.3.5 Waiting Time Setting for the Sleep Mode
Perform this mode to set up the waiting time that takes before the Sleep Mode is
started. (default: 1 minute)
Service
Mode No.
Item
n.19
Waiting time setting for the Sleep Mode
To change the waiting time for the Sleep Mode,
1. Select n.19 by pressing the jog dial, then the default time “001” (1 minute) is
displayed on the Control Panel as shown in the following figure (right).
2. The waiting time can be modified from 1 to 999 minutes.
Turn the jog dial to set the time, and save the setting.
3. Check if it has been correctly saved.
5. Service Mode
54 EzRay Air (Model: VEX-P300) User Manual
5.3.6 Waiting Time Setting for the Power Off Mode
Perform this mode to set up the waiting time for the Power Off Mode. (default: 30
minutes)
Service
Mode No.
Item
n.20
Waiting time setting for the Power Off Mode
To change the waiting time for the Power Off Mode,
1. Select n.20 by pressing the jog dial, then the default time “030” (30 minutes) is
displayed on the Control Panel as shown in the following figure (right).
2. The waiting time can be modified from 1 to 999 minutes.
Turn the jog dial to set the time, and save the setting.
3. Check if it has been correctly saved.
5. Service Mode
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ENGLISH
5.3.7 Waiting Time Setting for the Power Save Mode
Perform this mode to set up the waiting time for the Power Save Mode. (default: 4
hours)
Service
Mode No.
Item
n.21
Waiting time setting for the Power Save Mode
To change the waiting time for the Power Save Mode,
1. Select n.21 by pressing the jog dial, then the default time “240” (240 minutes) is
displayed on the Control Panel as shown in the following figure (right).
2. The waiting time can be modified from 1 to 999 minutes.
Turn the jog dial to set the time, and save the setting.
3. Check if it has been correctly saved.
5. Service Mode
56 EzRay Air (Model: VEX-P300) User Manual
5.3.8 Buzzer On/Off
Perform this mode to turn On/Off the buzzer. In case of ‘buzzer On’, there are three
options: battery level 1 (flickering) warning only, Power Off Mode warning only, or both.
(For details about battery levels, see ‘4.4.14.5Remote Exposure Switch
The Remote Exposure Switch allows the operator to control image acquisition from
outside of the X-ray room.
Press and hold the Remote Exposure Switch until the acquisition is completed.
Premature release of the Remote Exposure Switch will abort image acquisition.
Pressing the Remote Exposure Switch activates the X-ray Exposure Indicator to turn
yellow. This color indicates that the X-ray is being emitted.
The Remote Exposure Switch is detachable. Ensure that the
Remote Exposure Switch cable is not detached out from the unit
accidentally during the operation.
Keep vocal/visual contact with the patient during exposure. If any
problem occurs during exposure, release the Remote Exposure
Switch immediately.
5. Service Mode
EzRay Air (Model: VEX-P300) User Manual 57
ENGLISH
Using the Battery’ on page 37.)
Service
Mode No.
Item
n.22
Buzzer On/Off
To change the buzzer On/Off setting,
1. Select n.22 by pressing the jog dial, then the default setting “000” (buzzer Off) is
displayed on the Control Panel as shown in the following figure (right).
2. Turn the jog dial to select an option out of the four options as described below.
“000” = Buzzer Off (default)
“001” = Buzzer On for battery level 1 (flickering) warning only
“002” = Buzzer On for Power Off Mode warning only
“003” = Buzzer On for both
3. Save the setting, and check if it has been correctly saved.
5. Service Mode
58 EzRay Air (Model: VEX-P300) User Manual
5.3.9 Power Off Mode On/Off
Perform this mode to turn on/off the Power Off Mode.
Service
Mode No.
Item
n.23
Power Off Mode On/Off
To change the Power Off Mode On/Off setting,
1. Select n.23 by pressing the jog dial, then the default setting “001” is displayed on
the Control Panel. (“001” = On, “000” = Off)
2. To turn off the Power Off Mode, change the setting from “001” to “000” by
turning the jog dial.
3. Save the setting, and check if it has been correctly saved.
4. To turn on the Power Off Mode again, follow the same procedure as described
above.
5. Service Mode
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5.3.10 Password Setting
Perform this mode to change the password.
Service
Mode No.
Item
n.24
Password setting
To change the password,
1. Select n.24 by pressing the jog dial, then the default password “000” is displayed
on the Control Panel as shown in the following figure (right).
2. When the first digit flashes, turn the jog dial to change the password and then
save it by pressing the jog dial.
3. Follow the same procedure for the next two digits.
4. Check if the new password has been correctly saved.
6. Troubleshooting
60 EzRay Air (Model: VEX-P300) User Manual
6. Troubleshooting
In instances of abnormal operation, error messages will be displayed on the Control
Panel. If a problem persists, please request assistance from the customer support
information services.
Alarm/Error Messages
A.0X: A problem occurred, and the system performs the correction
automatically. This alarm clears after the correction is completed.
E.0X: An error occurred. Turn the power off, and then turn it back on. If
the error persists, contact your Service Representative.
Error Code
Check Parameter
Description
E.02
X-ray Generator
Error related to X-ray exposure is not possible to
exposure X-ray in the state while "E.02", "E.03",
"E.04", "E.05" where power is maintained.
After X-ray exposure related error occurs, when
the equipment is turned off and turned on, X-ray
exposure is normally performed.
E.03
E.04
E.05
A.06
X-ray Generator
Appears when the system needs cooling time
due to continuous operation. This alarm clears
when the system temperature goes down to
normal.
A.07
System
Appears when the Remote Exposure Switch has
been held down. Release the switch.
A.08
User
Appears when the exposure button has been
pressed and released before the X-ray exposure
finished with the default exposure time. Press
and hold the exposure button for the duration of
the exposure time.
A.09
Battery
Appears when the battery voltage is higher than
the reference value. Check the battery.
A.10
Appears when the battery voltage is lower than
the reference value during X-ray exposure.
Charge the battery.
A.11
Appears when the battery is being charged.
Operate the system after disconnecting the
battery charger from the system.
E.12
Appears when battery level is below the
reference value while X-ray exposure.
6. Troubleshooting
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ENGLISH
Troubleshooting
Problem
Cause
Solution
Equipment is not
turned on.
The power switch is not
turned on properly.
Turn the equipment power switch
off and turn it back on.
Battery discharged
Recheck after charging the battery
with a charger.
Battery cable is not
properly connected.
Contact your Service
Representative.
Defective battery
Contact your Service
Representative.
Control Panel is
not turned on.
Defective main board
Contact your Service
Representative.
Internal cable
disconnected
Contact your Service
Representative.
No X-ray emission
The generator is cooling.
Wait for the cooling time (refer to
‘Duty Cycle’ on page 70).
Defective Remote
Exposure Switch
Contact your Service
Representative.
Internal cable
disconnected
Contact your Service
Representative.
Defective generator
Contact your Service
Representative.
Tube lifecycle termination
Contact your Service
Representative.
X-ray emission
works, but
exposure is too
light or
completely white.
Equipment has been
positioned incorrectly.
Adjust the position of the
equipment.
Exposure time is too
long.
Decrease the exposure time.
The receptor is facing the
wrong way.
Reposition the receptor.
X-ray emission
works, but
exposure is too
dark.
Exposure time is too
short.
Increase the exposure time.
7. Cleaning and Maintenance
62 EzRay Air (Model: VEX-P300) User Manual
7. Cleaning and Maintenance
7.1 Cleaning
Before cleaning the equipment, make sure to turn off the equipment.
The equipment surfaces can be cleaned with a soft cloth damped in an alcohol-
based, non-corrosive cleaning solution. If necessary, wipe off surfaces with
disinfectant.
If necessary, wipe off surfaces with disinfectant.
When cleaning the surfaces, make sure that the equipment is not
connected to the battery charger.
DO NOT expose the equipment to any liquids.
DO NOT use spray cleaner or disinfectant directly into the equipment
as this could cause a fire.
The soft cloth should be damp, but not dripping wet.
The cloths or wipes cannot be re-used.
7. Cleaning and Maintenance
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7.2 Maintenance
VATECH requires periodic constancy tests to ensure image quality and the safety of
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.
Cautions and Notes
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.
When the equipment is not in use for a long time, fully charge the
battery and remove it from the device before storage.
It is recommended that charge the battery every six months during
storage.
7. Cleaning and Maintenance
64 EzRay Air (Model: VEX-P300) User Manual
7.2.1 Maintenance Task Checklist
Always turn off the equipment before performing any maintenance.
Tasks
Period
Before the operation, ensure that the equipment is clean and
ready for use.
Daily
After using the equipment, make sure that the equipment has
been turned off.
Daily
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
outer covers of the equipment.
Daily
Ensure that the signal is audible and the X-ray emission light is
visible when making an exposure.
Daily
Ensure that the yellow (exposure) indicator light turns on when
the Exposure Button is pressed.
Daily
Ensure that the battery charging LED indicator comes on when
charging the battery.
Daily
Ensure that the battery level indicator displays at least two
levels (Battery Level 2). For more information on the battery
levels, see ‘4.5 Using the Battery’ on page 37.
Daily
Ensure that all visible labels are intact and legible.
Monthly
If any defects are found, do not operate the equipment since it has to
be handled by a qualified person. Contact your Service Representative.
7. Cleaning and Maintenance
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8. Disposing of the Unit
66 EzRay Air (Model: VEX-P300) User Manual
8. Disposing of the Unit
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)
Part
Material
Recyclable
Waste
Disposal
Site
Hazardous waste;
Needs Separate
Collection
Covers
Plastics ●
Boards ●
Cables and
transformer
Copper ●
Packing
Polystyrene
●
Cardboard
●
Paper ●
X-ray tube ●
Battery ●
Other parts
●
Observe all regulations relevant to the disposal of waste in your
country.
This symbol on the equipment and/or accompanying documents
means that used electrical and electronic equipment (WEEE) should
not be mixed with general household waste.
For professional users in the European Union:
When discarding electrical and electronic equipment (EEE), please
contact your dealer or supplier for further information.
For disposal in countries outside of the European Union:
This symbol is only valid in the European Union (EU). When discarding
this equipment, please contact your local authorities or dealer and ask
for the correct disposal method.
8. Disposing of the Unit
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9. Equipment Specifications
68 EzRay Air (Model: VEX-P300) User Manual
9. Equipment Specifications
9.1 Mechanical Specifications
Dimensions
Item
Description
Main Body
Dimension (mm)
280(L) x 296(H) x ø 165
Weight (kg)
1.8 (± 10 %)
X-ray Beam
Limiting
Device
X-ray Beam
Area (mm)
Round Type
FOV: < ø 60
Rectangular Type
FOV: 20 x 30, 40 x 30
SSD(Source to Skin Distance) (mm)
200
9. Equipment Specifications
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9.2 Technical Specifications
X-ray Generator
Item
Description
High Voltage
Generator
(Assembly)
Model
DG-S0101V1
Rated output power
Max. 0.2 kW
Duty Cycle
1:30 or more
(Exposure time: Interval time)
Cooling Protection
Thermistor ≥ 60 °C
Inherent Filtration
1.8 mm Al / 65 kV
Total Filtration
Min. 1.5 mm Al
Type
Inverter Type
Tube Voltage
55-65 kV
Tube Current
1.0-3.0 mA
X-ray Tube
Manufacturer
VATECH Co., Ltd.
Model
V1-650304 (Stationary Anode type)
Focal spot size
0.4 mm (IEC 60336)
Anode heat contents
0.8 kJ
Maximum Anode Heat
Dissipation
200 W
Target Material
Tungsten
Target Angle
12.5°
Inherent Filtration
Min. 1.5 mm Al
X-ray Coverage
70 mm at SID 200 mm
Tube Voltage
Max. 65 kV
Tube Current
Max. 3.0 mA
9. Equipment Specifications
70 EzRay Air (Model: VEX-P300) User Manual
X-ray Tube Characteristics
1) Maximum rating chart
2) Emission characteristics
9. Equipment Specifications
EzRay Air (Model: VEX-P300) User Manual 71
ENGLISH
3) Heating and cooling curves of the X-ray tube
4) Heating and cooling curves of X-ray tube housing assembly
9. Equipment Specifications
72 EzRay Air (Model: VEX-P300) User Manual
5) Tube Dimensions [mm]
9. Equipment Specifications
EzRay Air (Model: VEX-P300) User Manual 73
ENGLISH
Battery
Battery - HPL603163-6S1P
Item
Description
Type
Rechargeable Li-ion Polymer
Nominal Capacity
900 mAh
Nominal Voltage
22.2 V d.c.
Charging Voltage
25.2 V d.c. (4.2 V d.c./Cell)
Discharge Voltage
18-25.2 V d.c.
Make sure to use the battery only provided or approved by VATECH.
Using an unauthorized battery may result in serious injury and
equipment damage. For details on using the battery, see ‘Battery Use’
on page 9.
The battery is consumable, so periodic replacement (every 6 months) is
recommended. (Battery warranty period: 6 months)
Battery Charger
Item
Description
Model
JBL7451251700002FJ
(Lithium-ion 6 Cells Battery charger)
Manufacturer
BRIDGEPOWER CORP
Rating
Input: 100-240 V~, 50-60 Hz, 1.0 A
Output: 25.2 V d.c., 1.7 A
Frequency
50-60 Hz
Standard
IEC 60950-1 (UL)
Power Cord
250 V, 10 A
Make sure to use the battery charger only provided or approved by
VATECH. Using an unauthorized charger may result in serious injury
and equipment damage. For details on using the battery charger, see
‘Battery Use’ on page 9.
▪ Power Supply is specified as a part of ME EQUIPMENT.
▪ Power plugs may have various specifications for each country.
9. Equipment Specifications
74 EzRay Air (Model: VEX-P300) User Manual
9.3 Electrical Specifications
Item
Description
Tube Voltage
65 kV fixed (± 5 %)
Tube Current
2.5 mA (± 10 %)
Exposure Time
0.05-0.5 s (± 2 %)
Rated Voltage
22.2 V d.c.
The system will be available with a fixed tube voltage specification
based on the user selection.
Maximum exposures on a full charge: about 300 times at 65 kV, 2.5 mA,
0.2 s
9.4 Environmental Specifications
Item
Description
During operating
Temperature
10 ~ 35 ℃
Relative humidity
30 ~ 75 %
Atmospheric pressure
860 ~ 1060 hPa
Transport and storage
Temperature
-10 ~ 60 ℃
Relative humidity
10 ~ 75 % non-condensing
Atmospheric pressure
860 ~ 1060 hPa
Failure to follow the specifications above can result in serious injury and
equipment damage.
9. Equipment Specifications
EzRay Air (Model: VEX-P300) User Manual 75
ENGLISH
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10. Appendix
76 EzRay Air (Model: VEX-P300) User Manual
10. Appendix
10.1 Tables of Exposure Times (Default)
The following exposure timetables were established with a unit equipped with a cone
that corresponds to a focus-to-skin distance of 200 mm (8 inches) respectively.
Patient
Teeth
Angle of
inclination
SSD: 200 mm (8 inches)
kV
mA
s
Adult
Incisor
Maxilla: +45˚
Mandible: -25˚
65
2.5
0.16
Canine
Maxilla: +45˚
Mandible: -20˚
65
2.5
0.19
Molar/
Premolar
Maxilla: +30˚
Mandible: -5˚
65
2.5
0.21
Bitewing
+5˚~ +8˚
65
2.5
0.23
Child
Incisor
Maxilla: +45˚
Mandible: -25˚
65
2.5
0.13
Canine
Maxilla: +45˚
Mandible: -20˚
65
2.5
0.16
Molar/
Premolar
Maxilla: +30˚
Mandible: -5˚
65
2.5
0.18
Bitewing
+5˚~ +8˚
65
2.5
0.20
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 77
ENGLISH
10.2 X-ray Dose Data
The X-ray dose data is extracted from the X-ray Dose Test Report for the VEX-P300.
The X-ray doses of the VEX-P300 in the test report were measured in accordance with
the IEC collateral standards. The VEX-P300 was designed in accordance with Part 1.
General Requirements for Safety, IEC 60601-1-3.
Test Condition
Model Name
VEX-P300
Tube Model Name
V1-650304
Generator Model Name
DG-S0101V1 (Inverter type)
Loading Factor
65 kV, 2.5 mA
10.2.1 X-ray Dose Table
Test Equipment
Instrument
Manufacturer
Model
S/N
Dose Meter
Piranha
255
CB2-0750141
Dose Table (65 kVp, 2.5 mA, FOV: Ø 6 cm, SSD 200 mm, at Al 6 mm)
t (s)
Dose (μGy)
0.05
50.9
0.08
91.2
0.1
117.9
0.15
185.1
0.2
252.1
0.25
319.2
0.3
386.2
0.45
587.4
0.5
654.4
10. Appendix
78 EzRay Air (Model: VEX-P300) User Manual
10.2.2 Leakage Dose
Scope
IEC 60601-2-65 203.12.4
Requirements
In the LOADING STATE, the AIR KERMA due to LEAKAGE RADIATION from X-RAY
SOURCE ASSEMBLIES, 1 m from the FOCAL SPOT, average over an area of 100
cm2 of which no principal linear dimension exceeds 20 cm, when operated at the
NOMINAL X-RAY TUBE VOLTAGE under condition of LOADING corresponding to the
reference LOADING conditions, shall not exceed 0.2 mGy in one hour.
Leakage Dose
Permissive Range
65 kVp, 2.5 mA, 0.5 s (Max. Exposure Condition)
At Focal Spot to Distance 1 m
1 : 30 Duty Cycle
< 0.2 mGy/h
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 79
ENGLISH
Results
The following exposure timetables were established with a unit equipped with a cone
that corresponds to a focus-to-skin distance of 200 mm (8 inches) respectively. When
the leakage doses have been measured with each cover type (default, rectangular
2x3, and rectangular 4x3), all the results have been ND (Not Detected).
The raw data about the results are shown in the table below.
The result (Horizontal Plane)
Direction
Default type
Rectangular 2x3
Rectangular 4x3
[mGy/h]
[mGy/h]
[mGy/h]
0°
ND
ND
ND
20°
ND
ND
ND
45°
ND
ND
ND
65°
ND
ND
ND
90°
ND
ND
ND
110°
ND
ND
ND
135°
ND
ND
ND
155°
ND
ND
ND
180°
ND
ND
ND
200°
ND
ND
ND
225°
ND
ND
ND
245°
ND
ND
ND
270°
ND
ND
ND
290°
ND
ND
ND
315°
ND
ND
ND
335°
ND
ND
ND
10. Appendix
80 EzRay Air (Model: VEX-P300) User Manual
The result (Vertical Plane)
Direction
Default type
Rectangular 2x3
Rectangular 4x3
[mGy/h]
[mGy/h]
[mGy/h]
0°
ND
ND
ND
20°
ND
ND
ND
45°
ND
ND
ND
65°
ND
ND
ND
90°
ND
ND
ND
110°
ND
ND
ND
135°
ND
ND
ND
155°
ND
ND
ND
180°
ND
ND
ND
200°
ND
ND
ND
225°
ND
ND
ND
245°
ND
ND
ND
270°
ND
ND
ND
290°
ND
ND
ND
315°
ND
ND
ND
335°
ND
ND
ND
▪ ND: Not Detected. The detection limit is 0.00001 mGy per exposure.
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 81
ENGLISH
10.2.3 Scattered Dose
Scope
IEC 60601-2-65 203.13
Requirements
ME EQUIPMENT shall be provided with means to optionally allow actuation of the
EXPOSURE from a PROTECTED AREA after installation.
Relevant instructions shall be given in the ACCOMPANYING DOCUMENTS.
Results
The following exposure timetables were established with a unit equipped with a cone
that corresponds to a focus-to-skin distance of 200 mm (8 inches) respectively.
Method 1
PMMA Phantom aligned to 280 mm away from Focal Spot
(with Position Indicating Device)
Max. Exposure Condition
Measure point: 500 mm from PMMA Phantom
Direction [°]
Result (Horizontal Plane) [μR]
Without Shield
With Shield
0°
69.3
76.2
20°
25.8
30.2
45°
27.6
28.6
65°
14.3
19.2
90°
27.9
33.6
110°
45.2
19.7
135°
43.7
13.6
155°
12.2
3.8
180°
2.8
1.4
200°
10.8
3.4
225°
42.7
13.2
245°
32.3
17.4
270°
36.2
25.6
290°
19.3
21.8
10. Appendix
82 EzRay Air (Model: VEX-P300) User Manual
Direction [°]
Result (Horizontal Plane) [μR]
Without Shield
Without Shield
315°
19.3
24.4
335°
32.7
28.5
Direction [°]
Result (Vertical Plane) [μR]
Without Shield
With Shield
0°
42.5
55.3
20°
39.0
30.7
45°
27.5
36.3
65°
35.5
41.8
90°
70.5
74.4
110°
34.0
38.0
135°
22.5
27.2
155°
30.8
34.1
180°
42.5
45.4
200°
63.1
25.3
225°
33.2
7.7
245°
16.7
2.9
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 83
ENGLISH
Direction [°]
Result (Vertical Plane) [μR]
Without Shield
With Shield
270°
1.7
0.8
290°
14.6
2.2
315°
33.2
12.6
335°
63.1
32.7
10. Appendix
84 EzRay Air (Model: VEX-P300) User Manual
Method 2
PMMA Phantom aligned to 280 mm away from Focal Spot
(with Position Indicating Device)
Max. Exposure Condition
Measure point: 1.0, 1.5, 2.0 m from PMMA Phantom
Direction [°]
Result (Horizontal Plane) [μR]
1.0 m
1.5 m
2.0 m
0°
45.7
28.6
11.4
20°
16.6
10.4
4.2
45°
17.2
10.7
4.3
65°
10.5
6.6
2.6
90°
18.5
11.6
4.6
110°
11.8
7.4
3.0
135°
8.2
5.1
2.0
155°
2.1
1.3
0.5
180°
0.8
0.5
0.2
200°
2.0
1.3
0.5
225°
7.2
4.5
1.8
245°
10.4
6.5
2.6
270°
14.1
8.8
3.5
290°
13.1
8.2
3.3
315°
13.4
8.4
3.4
335°
17.1
10.7
4.3
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 85
ENGLISH
Direction [°]
Result (Horizontal Plane) [μR]
1.0 m
1.5 m
2.0 m
Direction [°]
Result (Vertical Plane) [μR]
1.0 m
1.5 m
2.0 m
0°
33.2
20.7
8.3
20°
16.9
10.6
4.2
45°
21.8
13.6
5.4
65°
23.0
14.4
5.7
90°
40.9
25.6
10.2
110°
22.8
14.2
5.7
135°
16.3
10.2
4.1
155°
18.8
11.7
4.7
180°
27.2
17.0
6.8
200°
15.2
9.5
3.8
225°
4.2
2.6
1.1
245°
1.7
1.1
0.4
270°
0.4
0.3
0.1
290°
1.3
0.8
0.3
10. Appendix
86 EzRay Air (Model: VEX-P300) User Manual
Direction [°]
Result (Vertical Plane) [μR]
2.0 m
1.5 m
2.0 m
315°
6.9
4.3
1.7
335°
19.6
12.2
4.9
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 87
ENGLISH
10.3 Electromagnetic Compatibility (EMC) Information
Guidance and manufacturer’s declaration - electromagnetic emissions
The VEX-P300 is intended for use in the electromagnetic environment specified below. The
customer or the user of the VEX-P300 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment -
guidance
RF emissions CISPR 11
Group 1
The VEX-P300 uses RF energy only
for its internal function. Therefore, its
RF emissions are very low and are
not likely to cause any interference in
nearby electronic equipment.
RF emissions CISPR 11
Class A
The VEX-P300 is suitable for use in
all establishments other than
domestic and may be used in
domestic establishments and those
directly connected to the public lowvoltage power supply network that
supplies buildings used for domestic
purposes, Provided the following
warming is heeded:
Warning: This VEX-P300 is intended
for use by healthcare professionals
only. This equipment/system may
cause radio interference or may
disrupt the operation of nearby
equipment. It may be necessary to
take mitigation measures, such as reorienting or relocating the VEX-P300
or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
10. Appendix
88 EzRay Air (Model: VEX-P300) User Manual
Guidance and manufacturer’s declaration - electromagnetic immunity
The VEX-P300 is intended for use in the electromagnetic environment specified below. The
customer or the user of the VEX-P300 should assure that it is used in such an environment.
Immunity test
IEC 60601 Test
level
Compliance
level
Electromagnetic
environment -guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV Contact
±8 kV air
±6 kV Contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Main power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Main power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5 % Uт (> 95 %
dip in Uт) for
0.5cycle
40 % Uт (60 %
dip in Uт ) for 5
cycle, 6 cycle
70 % Uт (30 %
dip in Uт) for 25
cycle, 30 cycle
<5 % Uт (< 95 %
dip in Uт ) for 5 s
< 5 % Uт (> 95 %
dip in Uт) for
0.5cycle
40 % Uт (60 %
dip in Uт ) for 5
cycle, 6 cycle
70 % Uт (30 %
dip in Uт) for 25
cycle, 30 cycle
<5 % Uт (< 95 %
dip in Uт ) for 5 s
Main power quality should
be that of a typical
commercial or hospital
environment. If the user of
the VEX-P300 image
intensifier requires
continued operation
during power mains
interruptions, it is
recommended that the
VEX-P300 image
intensifier is powered from
an uninterruptible power
supply.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.
NOTE) Uт is the a.c. mains voltage prior to application of the test level.
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 89
ENGLISH
Guidance and manufacturer’s declaration - electromagnetic immunity
The VEX-P300 is intended for use in the electromagnetic environment specified below. The
customer or the user of the VEX-P300 should assure that it is used in such an
electromagnetic environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80MHz
3 V/m
80 MHz to
2.5 GHz
3 Vrms
3 V/m
Portable mobile RF
communications equipment
should be used no closer to any
part of the VEX-P300, including
cables, then the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a
should be less than the
compliance level in each
frequency range.
b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
NOTE 1) At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
10. Appendix
90 EzRay Air (Model: VEX-P300) User Manual
a
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 VEX-P300 is used exceeds the applicable RF compliance
level above, the VEX-P300 should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the VEXP300.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the VEX-P300
This is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the VEX-P300 can help Prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the VEX-P300 as recommended
below, according to the maximum output power of the communications equipment.
The rated
maximum
output power
of the
transmitter
[W]
Separation distance according to the frequency of transmitter [m]
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73 1 1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
10. Appendix
EzRay Air (Model: VEX-P300) User Manual 91
ENGLISH
10.4 Abbreviations
Acronym
Name
AL
Aluminum
EMC
Electromagnetic Compatibility
ESD
Electrostatic Discharge
FOV
Field of View
IEC
International Electro technical Commission
ISO
International Standards Organization
LED
Light-Emitting Diode
ME
Medical Electrical
PMMA
Poly Methyl Meth Acrylate
RF
Radio Frequency
SID
Source to Image receptor Distance
SIP
Signal Input Part
SOP
Signal Output Part
SSD
Source to Skin Distance
10. Appendix
92 EzRay Air (Model: VEX-P300) User Manual
Copyright by © 2017 VATECH Co., Ltd.
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.
VATECH and EzRay have registered trademarks in the United States and other countries, and
EzRay Air is a trademark of VATECH Co., Ltd. worldwide.
Reserved the right to make any alterations which may be required due to technical
improvement. For the most current information, contact your VATECH representative.
Manufactured by VATECH Co., Ltd.
Tel: (+82) 1588 9510
Email: gcs@vatech.co.kr
Website: www.vatech.co.kr
Head Quarters Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea
Factory Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea
The CE symbol grants this equipment compliance to the European
Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as
a class IIb device.
Authorized EU Representative: Vatech Dental Manufacturing Ltd. Suite
3, Ground Floor, Chancery House, St. Nicholas Way, Sutton, SM1 1JB
UK
Tel: (+44) 0208 652 1900, (+44) 0208 643 7109 Fax:
(+44) 0208 652 1909
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