Vatech EzRay Chair User manual

Notice
EzRay Chair (VEX-S300C) User Manual i
Notice
The EzRay Chair (VEX-S300C) is an intra-oral dental X-ray system.
This manual contains descriptions, operational instructions, imaging procedures for the
EzRay Chair (VEX-S300C) dental X-ray system. It is recommended that you
thoroughly familiarize yourself with this manual to make the most effective use of this
equipment. Read and understand all cautions, safety messages and warnings in this
manual.
Keep this manual with the equipment always and review the operating procedures and
safety instructions if needed.
The illustrations/photos of the equipment in this manual are only for illustration
purposes. The actual equipment may differ.
Due to continuous technological improvements, the manual may not contain the most
updated information. For further information not covered in this manual, please contact
us at:
Phone: [phone]
E-mail: [email protected]
This document is originally written in English.
The EzRay Chair (VEX-S300C) is referred to as Equipment or System in this
manual.
Manual Name: EzRay Chair (VEX-S300C) User Manual
Document number: VDH-UM-076
Version: 1.43
Publication Date: 2020-08

Notice
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Table of Contents
EzRay Chair (VEX-S300C) User Manual iii
Table of Contents
Notice ................................................................................................................ i
Table of Contents ...........................................................................................iii
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 ................................................................................................15
3.6 General View of the Equipment.............................................................16
4. Operation............................................................................................. 21
4.1 Power On/Off ........................................................................................21
4.2 Operation Mode ....................................................................................22
4.3 Positioning.............................................................................................27
4.4 Exposure ...............................................................................................32
5. Troubleshooting .................................................................................37
6. User Maintenance...............................................................................39
7. Cleaning and Disinfection .................................................................41
7.1 Cleaning ................................................................................................42
7.2 Disinfection............................................................................................42
8. Disposing of the Unit .........................................................................43
9. Product Specifications ...................................................................... 45
9.1 Mechanical Specifications .....................................................................45
9.2 Technical Specifications ........................................................................50
9.3 Electrical Specifications ........................................................................53
9.4 Environmental Specifications ................................................................54

Table of Contents
iv EzRay Chair (VEX-S300C) User Manual
Appendix ........................................................................................................55
A.1 Using the rotating rectangular cover ..................................................... 55
A.2 Tables of Exposure Times (Default) ...................................................... 57
A.3 X-ray Dose Data ................................................................................... 58
A.4 Electromagnetic Compatibility (EMC) Information ................................ 68
A.5 Abbreviations ........................................................................................ 71

1. General and Regulatory Information
EzRay Chair (VEX-S300C) User Manual 1
ENGLISH
1. General and Regulatory Information
1.1 Manufacturer's Liability
The manufacturers and retailers of this equipment assume responsibility for the safe
and healthy operation of this product only when:
Genuine VATECH approved equipment and components have always been used.
A VATECH authorized agent has performed all maintenance and repairs.
The equipment has been used generally by the user's manual.
The equipment damage or malfunction is not the result of an error on the part of
the owner or operator.
1.2 Owner and Operator's Obligations
The owner of this equipment shall perform constancy tests at regular intervals to
ensure patient and operator safety. These tests must be performed by 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 by the maintenance schedule outlined in Chapter 6 User
Maintenance.

1. General and Regulatory Information
2 EzRay Chair (VEX-S300C) User Manual
1.3 Conventions Used in this Manual
The following symbols are used throughout this manual. Make sure that you fully
understand each symbol and follow the instructions which accompany it.
To prevent personal injury and damage to the equipment, please observe all warnings
and safety information included in this document.
Indicates a potentially hazardous situation and improper
handling may result in:
Serious bodily injury (User or veterinary patient)
Substantial property damage
Indicates a potentially hazardous situation and improper
handling may result in:
Light injury
Property damage
Indicates a potentially harmful situation, and improper
handling may result in:
Property damage
Indicates a usage and other valuable information.

1. General and Regulatory Information
EzRay Chair (VEX-S300C) User Manual 3
ENGLISH
1.4 Marks and Symbols
The following table describes the purpose and location of safety symbols and other
valuable information provided on the equipment.
Mark/Symbol Description Location
Alternate current Main Label
Attention: consult accompanying
documents Main Label
Dangerous voltage
Power board,
X-ray
Generator,
Generator Label
Protective earth (Ground) Power Box
Base
Off (power: disconnected to the Main
Power Switch)
Main Power
Switch
On (power: connected to the Main Power
Switch)
Main Power
Switch
IEC60601-1
The degree of Protection from Electric
Shock
TYPE B Equipment
Main Label
Radiation hazard Main Label
,
Generator Label
Authorized European Representative
name and address Main Label
The CE symbol indicates that this product
complies with the European Directive for
Medical Devices 93/42/EEC as amended
by 2007/47/EC as a class IIb device.
Main Label
CSA mark
No.266436 Main Label

1. General and Regulatory Information
4 EzRay Chair (VEX-S300C) User Manual
Mark/Symbol Description Location
Prescription Requirement label
Caution: Federal law restricts this
device to sale by or on the order of a
licensed healthcare practitioner.
Main Label
Manufacturer’s name and address Main Label,
Generator Label
Date of manufacture Generator Label
Serial Number Generator Label
This symbol indicates that electrical and
electronic equipment should not be
treated as unsorted municipal waste and
must be collected separately.
Main Label
ESD susceptibility symbols indicate that
an item is susceptible to damage from
electrostatic discharges.
Board package
Refer to the User Manual. Main Label
This symbol indicates the direction of
cover attachment/detachment.
Cone’s upper
part

1. General and Regulatory Information
EzRay Chair (VEX-S300C) User Manual 5
ENGLISH
1.4.1 Label Locations
1. UDI Label
2. Main Label
2
1
2
3

1. General and Regulatory Information
6 EzRay Chair (VEX-S300C) User Manual
3. Generator Label
The labels in this manual are only for illustration purposes.
Actual labels may differ.

1. General and Regulatory Information
EzRay Chair (VEX-S300C) User Manual 7
ENGLISH
1.5 Standards and Regulations
Standards:
The EzRay Chair (VEX-S300C)is designed and manufactured to meet the following
standards:
IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-
65, IEC 62366
X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY VEX-S300C
IEC 60601-2-65:2012
CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1-3:09, CAN/CSA-
C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-2-65:15, CAN/CSA-IEC
62366:14
ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, C1:2009 / (R)2012 AND
A2:2010 / (R)2012 (Consolidated text - edition 3.1)
ISO 13485
21 CFR 1020.30 & 1020.31
The CE symbol grants this equipment compliance with the
European Directive for Medical Devices 93/42/EEC as
amended by 2007/47/EC as a class IIb device.
Classifications (IEC60601-1 6.1):
Protection against the ingress of water: Ordinary Equipment (IPX0)
Protection against electric shock: Class I equipment, Type B Applied Parts: Conehead

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2. Safety Instructions
EzRay Chair (VEX-S300C) User Manual 9
ENGLISH
2. Safety Instructions
2.1 General Safety Guidelines
Mode of operation: Continuous operation with cyclic loading—This equipment
needs a rest time of at least 60 times the exposure time before starting the next
exposure.
This equipment is designed and manufactured to ensure maximum safety of
operation. Operate and maintain it in strict compliance with the safety precautions
and operating instructions contained in this manual.
This equipment must only be operated by legally qualified persons.
Observe all local fire regulations. Always keep a fire extinguisher near the
equipment.
The equipment must be installed, maintained, and serviced by qualified service
personnel according to the procedures and preventive maintenance schedules.
Ensure that the on/off switch is set to off when the equipment is not in use.
Always disconnect the power supply before cleaning the equipment.
Don’t keep the equipment or its parts in a humid place or near a liquid substance.
Avoid placing the equipment near chemical storage and gas-filled storage
facilities.

2. Safety Instructions
10 EzRay Chair (VEX-S300C) User Manual
2.2 Warnings and Safety Instructions
This X-ray unit may be dangerous to patient and operator
unless safe exposure factors, operating instructions, and
maintenance schedules are observed.
It is essential to read this user manual carefully and strictly
abide by all warnings and cautions stated within it.
To avoid the risk of electric shock, this equipment must only
be connected to a supply main with protective earth.
Since rules and regulations concerning radiation safety differ
between countries, it is the responsibility of the owner and
operator of this equipment to comply with all applicable rules
and regulations concerning radiation safety and protection in
their area.
DO NOT open or remove the cover panels on this equipment.
DO NOT use spray cleaners on this equipment, as this could cause a fire.
DO NOT place flammable materials near this equipment.
Never expose this equipment to liquids, mists or sprays. Exposing this equipment
to liquids may cause an electrical shock or otherwise damage the system.
Never use this equipment in an environment that is susceptible to explosion.
Never touch the patient while also touching the SIP/SOP connectors.
Medical electrical equipment is subject to special EMC preventive measures. For
more details, refer to Section 1.A.4 Electromagnetic Compatibility (EMC)
Information.
Never try to modify this equipment, including the wires or cables. Modifying this
equipment may damage it beyond repair.
We recommend for 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.
Grave dangers may occur from electromagnetic interference (i.e., noise) between
other equipment in the area during specific examinations or medical treatment.

2. Safety Instructions
EzRay Chair (VEX-S300C) User Manual 11
ENGLISH
Radiation Safety
When using the equipment, it is recommended for all users
comply with the following radiation safety guidelines for the
safety of the users and the patients.
This equipment should be operated by a trained and qualified dentist or a dental
technician in a controlled environment.
All users and patients should wear protective equipment, such as a lead apron,
thyroid collar, et cetera.
Pregnant women should not be exposed to X-rays unless it is strictly necessary.
All users should comply with the Radiation Protection Policies established by the
government.
Any person or organization who installs an external Door Interlock Switch is
responsible for ensuring that the Switch has a radiation indicator or an equivalent
alarm system to show the state of current.
This equipment should be operated at least 2 m away from the operator when
operated in or outside of the room. For details on the Scattered Dose data, please
see ‘Scattered Dose’ on page 64 in Appendix.

2. Safety Instructions
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