Innolux Yushan series User manual

Yushan Series

X-Ray Flat Panel Detector

Operation Manual

INNOLUX Corporation

Radiologist or any other practitioners licensed

adequate knowledge of the operation prior using the

Flat Panel Detector.

This Operation

Manual should be studied and understood before proceeding

to op

erate the equipment on patients; it describes deta

the INNOLUX Yushan X

when operating it.

After reading this manual, store it nearby the

Panel Detector

so that you can see it whenever necessary

"Caution: Fede

ral Law restricts this device to sale by or

radiologist or any other practitioners licensed by the law of the state in which

that person practices to use or order the use of the device.

_____________________________________________________________

Caution

This Operation

Manual contains confidential and proprietary information of the

Manufacturer.

Before using the device, please check local regulations. If any local legislation

violated, use cannot be authorized.

If additional training or material for training is needed, please directly

our official dealer or INNOLUX Representative.

_____________________________________________________________

Trademarks

Company names

described in this manual are the trademarks or registered

trademarks of INNOLUX Corporation or their respective holders.

Windows is the registered trademark of US Microsoft Corporation in the U.S.A.

and other countries.

INNOLUX Corporatio

Document Number: YS

Version: A1

Issued date: 2018/09/1

-Ray Products

Radiologist or any other practitioners licensed

should ensure that they have

adequate knowledge of the operation prior using the

INNOLUX

Manual should be studied and understood before proceeding

erate the equipment on patients; it describes deta

ils

on how to operate

the INNOLUX Yushan X

-Ray Flat Panel Detector

and cautions to be observed

After reading this manual, store it nearby the

INNOLUX Yushan X

so that you can see it whenever necessary

ral Law restricts this device to sale by or

the order of a

radiologist or any other practitioners licensed by the law of the state in which

that person practices to use or order the use of the device.

_____________________________________________________________

Manual contains confidential and proprietary information of the

Before using the device, please check local regulations. If any local legislation

violated, use cannot be authorized.

If additional training or material for training is needed, please directly

our official dealer or INNOLUX Representative.

_____________________________________________________________

described in this manual are the trademarks or registered

trademarks of INNOLUX Corporation or their respective holders.

Windows is the registered trademark of US Microsoft Corporation in the U.S.A.

INNOLUX Corporatio

OM-01

should ensure that they have

ushan X-Ray

Manual should be studied and understood before proceeding

on how to operate

and cautions to be observed

INNOLUX Yushan X

-Ray Flat

the order of a

radiologist or any other practitioners licensed by the law of the state in which

_____________________________________________________________

Manual contains confidential and proprietary information of the

Before using the device, please check local regulations. If any local legislation

If additional training or material for training is needed, please directly

contact

_____________________________________________________________

described in this manual are the trademarks or registered

trademarks of INNOLUX Corporation or their respective holders.

Windows is the registered trademark of US Microsoft Corporation in the U.S.A.

Table of Content

Chapter 1 Introduction ............................................................................................. 6

1.1 Product Introduction ............................................................................ 7

1.2 Product Series ....................................................................................... 7

1.3 Product Intended Use .......................................................................... 7

1.4 Product Significant Performance Characteristics ....................... 7

1.5 Product Intended Patient Population ..............................................

1.6 Product Intended Part of the body or type of tissue applied to

or interacted with ..............................................................................................

1.7 Product Intended user profile ............................................................ 9

1.8 Product Intended conditions of use ................................................ 9

1.9 Product Features ................................................................................. 10

1.10 Clinical Guide ....................................................................................... 10

Chapter 2 Safety and Regulatory ........................................................................ 11

2.1 Compliance Standards and Classification ........................................ 11

2.1.1 Compliance Standards ................................................................ 11

2.1.2 Classification.................................................................................. 12

2.2 Contraindications ..................................................................................... 12

2.3 Power Supply Hazard .............................................................................. 12

2.4 Electric Shock Hazard ............................................................................. 12

2.5 Abnormalities Hazard .............................................................................. 14

2.6 Installation Precautions .......................................................................... 14

2.7 Connection Instructions ......................................................................... 15

2.8 External Network Connection ............................................................... 15

2.9 System Isolation Instructions ............................................................... 16

2.10 Software Precautions ............................................................................ 17

2.11 Disinfection Instructions ...................................................................... 17

2.12 Charging the Battery Pack ................................................................... 1

2.13 Battery Pack Instructions .................................................................... 19

2.14 Other Precautions .................................................................................. 22

2.15 Disposal of Waste .................................................................................. 24

2.16 Product Labels ........................................................................................ 24

2.16.1 Identification Label ..................................................................... 25

2.16.2 Battery Polarity Label ................................................................ 25

2.16.3 Battery Label ................................................................................ 26

2.16.4 Packing Carton Label ................................................................ 26

2.16.5 Adapter Specification Label ..................................................... 26

2.16.6 Safety Symbols ........................................................................... 27

3.1 How to Connect FPD ............................................................................... 2

3.2 Unit Names and the Functions ............................................................. 29

3.2.1 Flat Panel Detector ....................................................................... 29

3.2.2 Accessories .................................................................................... 30

3.3 LED indicators ........................................................................................... 33

Chapter 4 Basic Operation ................................................................................... 34

4.1 Preparing the Flat Panel Detector ........................................................ 34

4.1.1 Type of Flat Panel Detector ........................................................ 34

4.1.2 Number of the Connectable Flat Panel Detector .................. 34

4.1.3 Connecting/Disconnecting the Flat Panel Detector ............ 34

4.1.4 Charging the Battery Pack for the Flat Panel Detector ....... 35

4.1.5 Installing/Removing the Battery Pack for the Flat Panel

Detector ..................................................................................................... 35

4.1.6 LED Indicator to show battery capacity .................................. 36

4.2 Detector Connection................................................................................ 37

4.2.1 Wire connection ............................................................................ 37

4.2.2 Wireless connection ..................................................................... 3

4.2.3 AP mode connection .................................................................... 39

4.3 Starting Up and Shutting Down the Yushan FPD ............................ 41

4.3.1 Starting Up the Yushan ............................................................... 41

4.3.2 Overview of User Interface ......................................................... 41

4.3.3 Search and connect FPD ............................................................ 42

4.3.4 Enter the operation and select the mode ............................... 44

4.3.5 Performing an Exposure and Image Acquistion .................. 45

4.3.6 Download image from FPD ......................................................... 4

4.3.7 Shutting Down the Yushan ......................................................... 49

4.4 Correction procedure .............................................................................. 50

4.4.1 Collect images ............................................................................... 50

4.4.2 Correction process ....................................................................... 51

4.4.3 Storage of calibration data ......................................................... 53

5.1 Daily User Inspection and Maintenance ............................................. 54

5.1.1 Periodical Inspection ................................................................... 54

Chapter 6 Troubleshooting .................................................................................. 55

Appendix A Specifications of FPD ..................................................................... 56

A.1 Specifications ........................................................................................... 56

A.1.1 Reduced Equivalent ..................................................................... 56

A.1.2 Power Supply Conditions when Using Back-up Cable ...... 56

A.1.3 Power Supply to Battery Charger ............................................ 57

A.1.4 Power Consumption and Battery Specification ................... 57

A.1.5 Environmental Conditions ......................................................... 57

A.1.6 Image Performance ...................................................................... 59

A.1.7 Radio Waves .................................................................................. 60

A.1.8 Reliability and Lifetime ............................................................... 60

Appendix B Electromagnetic Compatibility (EMC) ........................................ 62

B.1 Yushan FPD ............................................................................................... 62

B.2 Further Information for IEC 60601-1-2 (EN 60601-1-2) ................... 63

Appendix C Radio Frequency (RF) Compliance Information ...................... 64

Chapter 1

This manual is intended to provide the operator with an overview of the

operation and safety requirements for the

Detector. This manual is not intended to provide instructions on actual

treatment procedures and it is expected that users should have official

radiologist or any other practitioners

Manufacturer and Di

stribution organization assume no liability thro

of the device.

All care has been taken in the preparation and checking of this manual

however there is no guarantee provided that all information is correct. The

information provided in this manua

Only CE or FDA approved or authorized

device

. The Manufacturer and Distribution organization shall not be held liable

or responsible for damages or injury caused as a result of

accessories.

Installation may only be conducted by authorized service

personal.

Some maintenance and service work

authorized service agents and only those procedures outlined in the operator

and service manual are all

person will void all warranties. No circuit diagrams or component part lists are

be provided for this device

provided in this manual then please conta

distributor in writing with your reasons for wanting them and then a copy of the

service manual may be provided. Before using the

Flat Panel Detector,

the operator should read this manual carefully and

particular attention to the sections of Safety, Operation and Maintenance.

________________________________________

Caution

INNOLUX Corporation shall not be liable for malfunctions and damages

resulting from use under

conditions for this product such as power supply, installation environment, etc.

contained in this manual.

INNOLUX Corporation shall not be liable for malfunctions and damages

resulting from natural disaste

etc.

_____________________________________________________________

-Ray Products

Chapter 1

Introduction

This manual is intended to provide the operator with an overview of the

operation and safety requirements for the

INNOLUX Yushan X-

Ray Flat Panel

Detector. This manual is not intended to provide instructions on actual

treatment procedures and it is expected that users should have official

radiologist or any other practitioners

license prior to using the

stribution organization assume no liability thro

All care has been taken in the preparation and checking of this manual

however there is no guarantee provided that all information is correct. The

information provided in this manua

l is subject to change without notice.

Only CE or FDA approved or authorized

accessories may be used in this

. The Manufacturer and Distribution organization shall not be held liable

or responsible for damages or injury caused as a result of

using no

Installation may only be conducted by authorized service

Some maintenance and service work

also

must be carried out by

authorized service agents and only those procedures outlined in the operator

and service manual are all

owed. Any service work carried out by unauthorized

person will void all warranties. No circuit diagrams or component part lists are

be provided for this device

. If you require technical documentation that is not

provided in this manual then please conta

ct the manufacturer or your local

distributor in writing with your reasons for wanting them and then a copy of the

service manual may be provided. Before using the

INNOLUX

Yushan X

the operator should read this manual carefully and

particular attention to the sections of Safety, Operation and Maintenance.

________________________________________

____________________

INNOLUX Corporation shall not be liable for malfunctions and damages

resulting from use under

environment conditions outside the range of using

conditions for this product such as power supply, installation environment, etc.

contained in this manual.

INNOLUX Corporation shall not be liable for malfunctions and damages

resulting from natural disaste

rs such as fires, earthquakes, floods, lightning,

_____________________________________________________________

This manual is intended to provide the operator with an overview of the

Ray Flat Panel

Detector. This manual is not intended to provide instructions on actual

treatment procedures and it is expected that users should have official

license prior to using the

device. The

stribution organization assume no liability thro

ugh the use

All care has been taken in the preparation and checking of this manual

however there is no guarantee provided that all information is correct. The

l is subject to change without notice.

accessories may be used in this

. The Manufacturer and Distribution organization shall not be held liable

using no

n-approved

Installation may only be conducted by authorized service

must be carried out by

authorized service agents and only those procedures outlined in the operator

owed. Any service work carried out by unauthorized

person will void all warranties. No circuit diagrams or component part lists are

. If you require technical documentation that is not

ct the manufacturer or your local

distributor in writing with your reasons for wanting them and then a copy of the

Yushan X

-Ray

the operator should read this manual carefully and

pay

particular attention to the sections of Safety, Operation and Maintenance.

____________________

INNOLUX Corporation shall not be liable for malfunctions and damages

environment conditions outside the range of using

conditions for this product such as power supply, installation environment, etc.

INNOLUX Corporation shall not be liable for malfunctions and damages

rs such as fires, earthquakes, floods, lightning,

_____________________________________________________________

1.1 Product Introduction

INNOLUX Yushan X-Ray Flat Panel Detector is an X-ray image acquisition

device that is based on flat-panel. This device should be integrated with an

operating PC and an X-ray generator. It can do to utilize as digitalizing X-ray

images and transfer for radiography diagnostic. Each X ray photon will be

converted to electronic signal by scintillator and the sensor array. Electronic

signal in the pixel will be readout by driver IC and then become an image

before send to PC.

1.2 Product Series

Model Description

Yushan V14C Glass version 14”x 17” FPD with CsI

Yushan V14G Glass version 14”x 17” FPD with GOS

1.3 Product Intended Use

The Wireless/Wired INNOLUX Yushan X-Ray Flat Panel Detector is intended

to capture for display radiographic images of human anatomy. It is intended for

use in general projection radiographic applications including pediatric and

neonatal exams wherever conventional film/screen or CR systems may be

used. The INNOLUX Yushan X-Ray Flat Panel Detector is not intended for

mammography, fluoroscopy, tomography, and angiography applications.

INNOLUX Yushan series provide either raw X ray image or corrected image

for system integrator to do further image process.

1.4 Product Significant Performance

Characteristics

Items Characteristics

Image resolution 2500x3052

Data 16 bit data

MTF (Modulation transfer

function) (Typical)

CsI 0.69 @ 1 lp/mm

0.39 @ 2 lp/mm

0.22 @ 3 lp/mm

GOS 0.52 @ 1 lp/mm

0.23 @ 2 lp/mm

0.11 @ 3 lp/mm

DQE (Detector quantum

efficiency) (Typical)

CsI

0.51 @ 0 lp/mm

0.48 @ 1 lp/mm

0.39 @ 2 lp/mm

0.29 @ 3 lp/mm

GOS

0.31 @ 0 lp/mm

0.27 @ 1 lp/mm

0.16 @ 2 lp/mm

0.09 @ 3 lp/mm

Maximum linear dose (Typical) 88 uGy

Sensitivity (Typical) CsI 574 lsb/uGy

GOS 592 lsb/uGy

Dark noise (Typical) CsI 4.5 LSB

GOS 7.9 LSB

Lag <0.5% after 1 minute

1.5 Product Intended Patient Population

Considerations Requirement Description

Age -Not restricted

Height -Not restricted

Weight

-The uniform load of the device is 300kg

-The local load on 4 cm diameter of the

device is 120kg.

*Note: Please evaluate the patient’s

condition before using.

Health -Not restricted

Nationality -Multiple

Sex -Not restricted

1.6 Product Intended Part of the body or type of

tissue applied to or interacted with

-Measurement site: body

-Condition: Intact or wound skin

1.7 Product Intended user profile

Considerations Requirement Description

Education Minimum -Graduate of radiology college

Maximum -No maximum

Knowledge Minimum

-Read and understand 'westernized

Arabic' numerals when written in Arial

font

-Can distinguish of human body

-Understands hygiene

Maximum -No maximum

Language

Understanding

Minimum -Local language

Maximum -Understand the operation manual that

is writing in English

Experience Minimum -Physician or legally certified operator

Maximum -No maximum

_____________________________________________________________

Note

Patient should not operate the device by its own, in case result in malfunction

of the equipment.

_____________________________________________________________

1.8 Product Intended conditions of use

Considerations

Condition

Environment including

hygienic requirements

-Non-sterile

-Multiple patient use

-Less than ten minute contact

-Indoor use only

-Ambient luminance range: 100 to 1500 lx

-Viewing angle: normal to the display ±20°

Frequency of use -Reusable

-1day: 200 shot

Location -In hospital environment

Mobility -Portable ME equipment to be used on a

patient

1.9 Product Features

-140 micron pixel pitch

-Wide image

-16-bit dynamic range output

-Exposure times up to 3.0 seconds

-Wireless communication mode or wired communication mode is available.

When used in wireless communication mode, an access point and battery

pack (optional) are required.

1.10 Clinical Guide

Users may require to attend the traning courses held by INNOLUX before

using. A complete training should consist of the following elements:

-All safety precautions for practitioners and patients when using the device.

-A review of published clinical literature should be conducted to understand

the indications and effects of the X-Ray Flat Panel Detector.

_____________________________________________________________

Note

It is strongly recommended for INNOLUX Yushan practitioners to attend

organized meetings, workshops, seminars, and conferences on use of X-Ray

Flat Panel Detector.

_____________________________________________________________

Chapter 2 Safety and Regulatory

This INNOLUX Yushan X-Ray Flat Panel Detector has been designed and

tested to function in a safe and correct when used as indicated in this manual.

Do not use this device before reading and completely understand this

Operation Manual. Always observe precautions for safety and only operates

the device in a qualified room that provides protection.

2.1 Compliance Standards and

Classification

2.1.1 Compliance Standards

-FDA Standards 21 CFR 1020.31 for ionizing radiation emitting products

-FDA Standards 21 CFR 892.1680 for stationary x-ray system

-European Medical Devices Directive (93/42/EEC)

-EN ISO 13485:2016

-EN ISO 14971:2012

-EN 60601-1: 2006+A1: 2013+A12: 2014

-ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012

and A2:2010/(R)2012

-CAN/CSA C22.2 No. 60601-1:14

-EN 60601-1-2:2015

-IEC 62304:2006/Amd 1:2015

-EN 60601-1-6: 2010/A1:2015

-EN 62366-1: 2015

-EN ISO 10993-1:2009/AC:2010

-EN ISO 10993-5:2009

-ISO 10993-10:2010

-EN 1041:2008

-EN ISO 15223-1:2016

-RED Directive (2014/53/EU)

-RoHS Directive (2011/65/EU)

-REACH Directive (EC/1907/2006)

WEEE Directive (2012/19/EU)

2.1.2

Classification

Type of protection against electrical shock: Class I Equipment

Degree of protection a

Degree of protection against harmful ingress of water: IPX6

rating does not indicate

tested for compliance with, any other IPX_ ratings.

Degree of safety of application in the presence of a flammable anesthetics

mixture with air or with oxygen or nitrous oxide: Equipment not suitable for

e in the presence of a flammable anesthetics mixture with air or with

oxygen or nitrous oxide.

2.2 Contraindications

No contraindications present.

2.3 Power Supply Hazard

_____________________________________________________________

Warning

The power

supply to the Yushan is AC 100 to 240V.

To avoid electric shocks, users should always take the following precautions:

Do not open any covers when it is not necessary.

Install the equipment in a location where it will not be exposed to water.

-Check that the

equipment is securely earthed.

Check that all of the cables are completely and securely connected.

Keep the control cabinet out of reach of patients.

_____________________________________________________________

2.4

Electric S

_________________

____________________________________________

Warning

-Ray Products

Classification

Type of protection against electrical shock: Class I Equipment

Degree of protection a

gainst electrical shock: Type B

Equipment

Degree of protection against harmful ingress of water: IPX6

rating does not indicate

compliance with, and the detectors have not been

tested for compliance with, any other IPX_ ratings.

)

Degree of safety of application in the presence of a flammable anesthetics

mixture with air or with oxygen or nitrous oxide: Equipment not suitable for

e in the presence of a flammable anesthetics mixture with air or with

oxygen or nitrous oxide.

2.2 Contraindications

No contraindications present.

2.3 Power Supply Hazard

_____________________________________________________________

supply to the Yushan is AC 100 to 240V.

To avoid electric shocks, users should always take the following precautions:

Do not open any covers when it is not necessary.

Install the equipment in a location where it will not be exposed to water.

equipment is securely earthed.

Check that all of the cables are completely and securely connected.

Keep the control cabinet out of reach of patients.

_____________________________________________________________

Electric S

hock Hazard

____________________________________________

Type of protection against electrical shock: Class I Equipment

Equipment

Degree of protection against harmful ingress of water: IPX6

(An IPX6