EzRay Air Portable Model VEX-P300 User Manual Ver 1.48 Sept 2020

Notice

This page is intentionally left blank.

vi

EzRay Air Portable (Model: VEX-P300) User Manual

Notice

Table of Contents Notice

v

Table of Contents

vii

1.

1

2.

3.

4.

5.

General and Regulatory Information 1.1

Manufacturer's Liability ... 1

1.2

Owner and Operator's Obligations ... 1

1.3

Conventions Used in this Manual ... 2

1.4

Marks and Symbols ... 3

1.5

Standards and Regulations ... 6

Safety Instructions

7

2.1

General Safety Guidelines ... 7

2.2

Warnings and Safety Instructions ... 8

System Overview

11

3.1

Indications for Use ... 11

3.2

Principles of Operation... 11

3.3

Intended User Profile ... 11

3.4

Components ... 12

3.5

Features ... 13

3.6

General View of the Device... 14

Operation

19

4.1

Power On/Off ... 19

4.2

Enter Password ... 20

4.3

Operation Mode ... 21

4.4

Positioning ... 23

4.5

Exposure ... 32

4.6

Using the Battery ... 34

Service Mode

43

5.1

Overview ... 43

5.2

Changing System Parameters ... 44

EzRay Air Portable (Model: VEX-P300) User Manual

vii

Notice

5.3

Service Mode Menu ... 47

6.

Troubleshooting

59

7.

Cleaning and Maintenance

63

7.1

Cleaning ... 63

7.2

Maintenance ... 64

8.

Disposing of the Unit

67

9.

Device Specifications

69

10.

viii

9.1

Mechanical Specifications ... 69

9.2

Technical Specifications ... 70

9.3

Electrical Specifications ... 74

9.4

Environmental Specifications ... 74

Appendix

75

10.1

Combining the Holder and the devices using a tripod ... 75

10.2

Using the Rotating Rectangular Cover ... 77

10.3

Tables of Exposure Times (Default) ... 79

10.4

X-ray Dose Data ... 83

10.5

Electromagnetic Compatibility (EMC) Information ... 92

10.6

Abbreviations ... 95

EzRay Air Portable (Model: VEX-P300) User Manual

1. General and Regulatory Information

General and Regulatory Information

1.1

Manufacturer's Liability

ENGLISH

1.

The manufacturers and retailers of this device assume responsibility for the safe and normal operation only when: 

Always using genuine VATECH approved devices and parts.



Performing all maintenance and repairs at a VATECH authorized distributor.



Using this device properly following the user manual.



The device damage or malfunction is not the result of an error on the owner or operator. Disclaimer: EzRay Air Portable (Model: VEX-P300) 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) device which has been damaged, modified, or tampered with in any way.

1.2

Owner and Operator's Obligations 

This device owner must perform constancy tests at regular intervals to ensure patient and operator safety. Local X-ray safety regulations must perform these tests.



This device owner must perform regular inspection and maintenance of the mechanical and electrical components to ensure safe and consistent operation (IEC 60601-1).



This device owner must ensure inspection and cleaning work is performed by the maintenance schedule outlined in Chapter 7 Cleaning and Maintenance. DO NOT operate this device until reading this manual and reviewed the related materials.

EzRay Air Portable (Model: VEX-P300) User Manual

1

1. General and Regulatory Information

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. Please observe all warnings and safety information included in this document to prevent personal injury and damage to the device. 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. Indicates a possible danger from radiation exposure.

2

EzRay Air Portable (Model: VEX-P300) User Manual

1. General and Regulatory Information

Marks and Symbols

ENGLISH

1.4

The following table describes the purpose and location of safety symbols and other valuable information provided on the device. Mark/Symbol

Description

Location

Alternate current

Battery Charger Label

Direct current

Main Label

Attention: Consult accompanying documents

Main Label

Dangerous voltage

Powerboard, 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 device complies with the European Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a class IIb device.

Main Label

UL mark No. E476672

Main Label

EzRay Air Portable (Model: VEX-P300) User Manual

3

1. General and Regulatory Information

4

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 devices 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 the removal of the screw.

Main Label

This symbol indicates the direction of cover attachment/detachment.

Cone’s upper part

EzRay Air Portable (Model: VEX-P300) User Manual

1. General and Regulatory Information

Label Locations

ENGLISH

1.4.1

1

2 1.

Generator Label

2.

Main Label

3.

UDI Label

3

The labels' design and contents may be different in some countries based on local regulations and standards.

EzRay Air Portable (Model: VEX-P300) User Manual

5

1. General and Regulatory Information

1.5

Standards and Regulations Standards: The device is designed and manufactured to meet the following standards: 

MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-3 (2008), IEC 60601-265(2012)



ISO 13485



21 CFR 1020.30 & 1020.31 This is Class IIb equipment and obtained CE marking in April 2007 for regulation compliance by the revised European Union’s MDD (Medical Devices Directive) 93/42 EEC. This equipment received the UL certification mark in accordance with ANSI/AAMI, CAN/CSA-C22.2 No. 60601-1 regulations.

Classifications (IEC60601-1 6.1): Protection against the ingress of water: Ordinary Equipment (IPX0) Protection against electric shock: Class II equipment, Type B Applied Parts: Backscatter Shield, Round Cover, Rectangular Cover, Rotating Rectangular Cover

6

EzRay Air Portable (Model: VEX-P300) User Manual

2. Safety Instructions

Safety Instructions

2.1

General Safety Guidelines 



















ENGLISH

2.

This device is designed and manufactured to ensure the most significant safety of operation. Operate and maintain it in strict compliance with the safety precautions and operating instructions contained in this manual. Only a legally qualified person, i.e., a radiographer, diagnostic radiographers, medical radiation technologists, or healthcare professionals who specialize in imaging medical for the diagnosis and treatment of pathology, can operate this equipment in a controlled environment. Observe all local fire regulations. Always keep a fire extinguisher near the device. The device must be installed, maintained, and serviced by qualified service personnel according to the procedures and preventive maintenance schedules. Users can perform an only battery replacement. Ensure that the on/off switch is set to off when the device is not in use. Always disconnect the power supply before cleaning the device. DO NOT keep the device or its parts in a humid place or a liquid substance. Avoid placing the device near chemical storage and gasfilled storage facilities. The backscatter shield protects users from backscatter radiation that they might be exposed to during X-ray exposure. Operating the device with the backscatter shield allows the users to be exposed to less radiation than when operating without. For details on the scattering data of the device configured both with and without the backscatter shield, please review 10.4.3 Scattered Dose. Wireless communication equipment is used no closer than 30 cm (12 inches) to any part of the EzRay Air Portable(Model: VEX-P300), including cables specified by VATECH.

This device is shipped with the backscatter shield attached (firmly fixed), so users can not replace the backscatter shield. If it is damaged or defective, contact your Service Representative for replacement. Mode of operation: Non-continuous operation with cyclic loading-This device needs a rest time of at least 60 times the exposure time before starting the next exposure.

EzRay Air Portable (Model: VEX-P300) User Manual

7

2. Safety Instructions

2.2

Warnings and Safety Instructions This X-ray unit may be dangerous to patients and operators 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.  To avoid the risk of electric shock, this device must only be connected to the 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 device 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 device.  Never expose this device to liquids, mists, or sprays. Exposing this device to liquids may cause an electrical shock or otherwise damage the system.  DO NOT use spray cleaners on this device, as this could cause a fire.  Never use this device in an environment that is susceptible to explosion.  DO NOT place flammable materials near this device.  Never touch the patient while also touching the SIP/SOP connectors. The medical electrical device is subject to special EMC preventive measures. For more details, refer to 10.5 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 device, including the wires or cables. Modifying this device may damage it beyond repair. Serious dangers may occur from electromagnetic interference (i.e., noise) between other devices in the area during specific examinations or medical treatment.

Battery chargers must be in an accessible area where they can be easily unplugged from the power source.

8

EzRay Air Portable (Model: VEX-P300) User Manual

2. Safety Instructions















 

 



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 shortcircuited by other metal objects. Observe the plus (+) and minus (-) marks on the battery and device and ensure correct use. DO NOT subject batteries to mechanical shock. In a cell leaking event, do not allow the liquid to meet 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 a prolonged charge when not in use. If the device has not been used for long periods, 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.

EzRay Air Portable (Model: VEX-P300) User Manual

9

ENGLISH

Battery Use

2. Safety Instructions

If the device not in use has been turned on for long periods, 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 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).   



Users can replace batteries. When charging the battery, the exposure function is locked. Be sure to turn off the device 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 

When using the device, it is recommended that all users comply with the following radiation safety guidelines for the users and the patients' safety.



All users and patients should wear a protective device, such as a lead apron, thyroid collar, etc. This device should be operated in an 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 cone's outer end for most operator protection.









10

EzRay Air Portable (Model: VEX-P300) User Manual

3. System Overview

System Overview The device, a portable dental X-ray system, operates on 21.6 Vdc supplied by a rechargeable Li-ion battery pack. The portable X-ray system is an X-ray generating device 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 device is designed to diagnose teeth and jaw through X-ray exposure using intra-oral image receptors.

3.1

Indications for Use EzRay Air Portable (Model: VEX-P300) is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dentist or a dental technician for both adult and pediatric patients.

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 device 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.

EzRay Air Portable (Model: VEX-P300) User Manual

11

ENGLISH

3.

3. System Overview

3.4

Components

No.

Item

Standard

Option

Qty.

1

Main Body (included the Backscatter Shield and the Round Cover)

●

1

2

Hand/Neck Strap

●

1

3

Rectangular Cover (4x3)

●

1

4

power cord

●

1

5

Battery Charger

●

1

6

User Manual

●

1

7

Cradle

●

1

8

Rectangular Cover (2x3)

●

1

9

Rotating Rectangular Cover (4x3)

●

1

10

Rotating Rectangular Cover (2x3)

●

1

11

Remote Exposure Switch

●*

1

12

Base Holder

●*

1

13

Tripod

●*

1

**Read the notice on the next page for the options with the symbol (*)

12

EzRay Air Portable (Model: VEX-P300) User Manual

3. System Overview

3.5

ENGLISH

The remote exposure switch, base holder, and tripod are provided with EzRay Air Portable (Model: VEX-P300) for users in the countries where a hand-held X-ray device is prohibited in the clinic. For more information, please contact a VATECH representative in your area.

Features The device 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.



A selection of phosphor plates or digital sensors

EzRay Air Portable (Model: VEX-P300) User Manual

13

3. System Overview

3.6

General View of the Device Main Body

14

No.

Item

Description

1

Backscatter Shield

2

X-ray Beam Limiting Device

3

X-ray Exposure Button

4

Handle

5

Power 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. Alternatively, it 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

11

X-ray Generator

Includes the X-ray tube and the high-voltage generator.

Shields from the backscattering radiation. Limits the X-ray exposure area. Default type: Round Cone + Round Cover (FOV: Ø 6 cm)

Press the button for X-ray exposure. Grip the handle securely when using the system. Power On/Off button

EzRay Air Portable (Model: VEX-P300) User Manual

3. System Overview

ENGLISH

Control panel

1 2 3

7

4

8 9

5

10

6

No.

Item

Description

1

Tube Voltage/Current Indicator

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).

Remaining Battery Indicator

Indicates remaining battery level.

Battery Charging Indicator

1) Indicates that 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.

Indicates the tube voltage and tube current of the system.

4

EzRay Air Portable (Model: VEX-P300) User Manual

15

3. System Overview

8

9

10

16

X-ray Exposure Indicator

Indicates the X-ray exposure status. (Green: Ready / Yellow: X-ray On)

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.

AUTO Button

Available only in countries that allow the auto mode for use. The mode is not available in the United Kingdom, the United States, and some countries. (Consult the sales representative in your country for details) In these countries, only “NA” is displayed on the panel when this button is pressed.

EzRay Air Portable (Model: VEX-P300) User Manual