Innolux 000001 User Manual

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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

Manual should be studied and understood before proceeding

erate the equipment on patients; it describes deta

the INNOLUX Yushan X

After reading this manual, store it nearby the

so that you can see it whenever necessary

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.

_____________________________________________________________

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

should ensure that they have

on how to operate

and cautions to be observed

INNOLUX Yushan X

the order of a

Flat Panel Detector. This Operation

to op

when operating it.

Panel Detector "Caution: Fede

Caution

This Operation

-Ray Flat Panel Detector

INNOLUX

ils

ushan X-Ray

-Ray Flat

Manufacturer.

Trademarks

Company names

contact

Document Number: YS

OM-01 Version: A1 Issued date: 2018/09/1

-Ray Products

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 .............................................. 8

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

or interacted with .............................................................................................. 8

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 ................................................................... 18

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 ............................................................................... 28

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 ..................................................................... 38

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 ......................................................... 48

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

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

Only CE or FDA approved or authorized

. The Manufacturer and Distribution organization shall not be held liable

or responsible for damages or injury caused as a result of

Installation may only be conducted by authorized service

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

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

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

_____________________________________________________________

Ray Flat Panel

license prior to using the

l is subject to change without notice.

accessories may be used in this

using no

must be carried out by

owed. Any service work carried out by unauthorized

. If you require technical documentation that is not

ct the manufacturer or your local

Yushan X

____________________

environment conditions outside the range of using

rs such as fires, earthquakes, floods, lightning,

Introduction

INNOLUX Yushan X-

device. The Manufacturer and Di of the device.

device

accessories. personal.

ugh the use

also

n-approved

Flat Panel Detector,

Caution

etc.

INNOLUX

-Ray Products

-Ray pay

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

0.69 @ 1 lp/mm

MTF (Modulation transfer function) (Typical)

CsI

GOS

0.39 @ 2 lp/mm

0.22 @ 3 lp/mm

0.52 @ 1 lp/mm

0.23 @ 2 lp/mm

0.11 @ 3 lp/mm

0.51 @ 0 lp/mm

CsI

DQE (Detector quantum efficiency) (Typical)

GOS

Maximum linear dose (Typical) 88 uGy

CsI 574 lsb/uGy

Sensitivity (Typical)

GOS 592 lsb/uGy

CsI 4.5 LSB

Dark noise (Typical)

GOS 7.9 LSB

Lag <0.5% after 1 minute

0.48 @ 1 lp/mm

0.39 @ 2 lp/mm

0.29 @ 3 lp/mm

0.31 @ 0 lp/mm

0.27 @ 1 lp/mm

0.16 @ 2 lp/mm

0.09 @ 3 lp/mm

1.5 Product Intended Patient Population

Considerations Requirement Description

1.6

Age

Height

Weight

Health

Nationality

Sex

Product Intended Part of the body or type of

- Not restricted

- The uniform load of the device is 300kg

- The local load on 4 cm diameter of the

*Note: Please evaluate the patient’s condition before using.

- Not restricted

- Multiple

- Not restricted

tissue applied to or interacted with

- Measurement site: body

- Condition: Intact or wound skin

device is 120kg.

1.7 Product Intended user profile

Considerations Requirement Description

Minimum

- Graduate of radiology college

Education

Maximum

- No maximum

- Read and understand 'westernized

Arabic' numerals when written in Arial

Minimum

font

Knowledge

- Can distinguish of human body

- Understands hygiene

Maximum

Minimum

- No maximum

- Local language

Language

- Understand the operation manual that

Understanding

Maximum

is writing in English

Minimum

- Physician or legally certified operator

Experience

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

Environment including hygienic requirements

- Non-sterile

- Multiple patient use

Condition

- 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 Mobility

- In hospital environment

- 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)

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

_____________________________________________________________

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

____________________________________________

Equipment

compliance with, and the detectors have not been

2.1.2

gainst electrical shock: Type B

)

(An IPX6

Warning

The power

- Check that the

2.4

hock Hazard

_________________

Warning

-Ray Products

Observe the following precautions when using the cables:

- Do not touch the plug and connector with wet hands. Otherwise, electric

shock may result causing death or severe injury.

- Hold the plug or connector when removing the cable.

- Pulling the cable or carrying by holding it may damage the cable, causing

fire or electric shock.

- Do not damage or remodel the cable.

- Do not place a heavy object on the cable or lay it under the flat panel

detector. Do not step on, pull, forcibly bend, or bundle the cable.

Otherwise, fire or electric shock may result.

- Do not use the flat panel detector for the

radiographic examination stand if its cable

becomes overloaded. Otherwise, the cable may

be damaged, causing fire or electric shock.

- Do not touch the back-up cable connector of

Yushan, otherwise it may result in electric shock

or malfunction of the equipment. Do not use the equipment in a location where metal particles could come into

the equipment. This may cause an electric shock. Do not disassemble or remodel the equipment. Otherwise, fire or electric

shock may result. Keep away from the parts inside the product, which may cause electric shock. If you touch them accidentally, death or severe injury may result.

Do not hit or drop the equipment or subject it to severe shock. Otherwise, the equipment may be damaged. If the damaged equipment is used, fire or electric shock may result.

Do not use the flat panel detector to lift up patient. In addition, do not apply strong pressure onto the

flat panel detector. If applied, the flat panel detector deforms and the waterproof function may be invalid.

Have the patient take a fixed posture and do not let the patient touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction of the equipment.

Do not use the flat panel detector without the battery packs. If the battery

packs are not attached, an electric shock may result.

the optional parts and accessories

Failure to use the optional parts and accessories recommended by us may

result in damage to the equipment and/or electric shock and injury.

Keep the equipment away from patient’s body fluids, chemical

Otherwise, it may be damaged, causing fire or electric shock. If necessary,

protect the flat panel detector by covering it with a disposable bag.

_____________________________________________________________

2.5 Abnormalities Hazard

_____________________________________________________________

If any of the following occurs, immediately turn off the power of each unit,

unplug the power cable from the outlet, and then contact our official dealer or

INNOLUX Representative.

hen smoke, strange odor, or abnormal sound is present.

● When a foreign object (such as a metal object) or liquid enters the product.

● When the equipment is dropped or hit and is damaged.

_____________________________________________________________

Installation Precautions

_____________________________________________________________

Do not install the equipment in a locatio

Where the temperature changes sharply.

Close to heat sources such as a heater.

the equipment may be exposed to water due to water leakage or

Where corrosive gas may be generated.

Where there is excessive dust.

Where the equipment is subject to frequent or excessive vibration/shock.

Where the equipment is exposed to direct

provided by innolux.

n with the following conditions:

Make sure to use

Warning

s, water, etc.

● W

2.6

Cautions

- Where

ingress.

sunlight.

-Ray Products

Use the equipment on a flat place. If the equipment falls, it may cause damage

to the equipment or personal injury.

When you move the equipment, place it in the cassette storage box of a mobile

ray unit or hold it by hand to prevent it from fal

the equipment, place it horizontally.

For veterinary or mobile applications, contact our official dealer or INNOLUX

When the devices are used outdoors in wireless communication mode, contact

aler or INNOLUX Representative.

Do not place any object in a place where removal of the power cable is

To ensure optimal image quality, it is recommended that you do not use the flat

near devices (motor, transformer, switching supply, etc.) that

generate electromagnetic noise.

To ensure optimal image quality, it is recommended that you do not place the

back

nsformer, switching supply, etc.) that generate electromagnetic

_____________________________________________________________

2.7 Connection Instructions

_____________________________________________________________

sure that the devices to be connected to the equipment are authorized

Yushan

_____________________________________________________________

External Network Connection

_____________________________________________________________

ling. If the cart is used to move

cable, etc.) of the equipment near devices

access point or DR system.

X-

Representative.

our official de

prevented.

panel detector

cables (power cable, (motor, tra noise and their cables.

-up

Warning

Make for connection.

Connect the panel unit

only to the

2.8

-Ray Products

When a setting of the network to which the equipment is connected has been

check that the change does not affect the system operation and take

setting change may include the following:

Change of connection destination

Removal of devices

Upgrade of devices

After connecting this system to the network with other systems, confirm that

the other systems are not af

such as network separation.

Make sure to use the optional parts, accessories and networks recommended

by us. Failure to use the optional parts, accessories and networks

recommended by us may resu

Connect to the Ethernet Network of 100BASE

the IEEE standard 802.3. Do not connect telephone lines to LAN connector.

type straight LAN cables of 4

higher are appropriate for connection to this connector.

_____________________________________________________________

System Isolation Instructions

_____________________________________________________________

ensure complete system isolation, never install any unauthorized

accessories or other such items.

When it is necessary to install authorized accessories or optional items,

fected. If they are affected, take countermeasures

lt in damage to the equipment and/or electric

T prescribed in

tegory 5 cable (CAT 5E) or

Caution

changed, measures if necessary.

The

- Addition of devices

- Update of devices

Warning

shock and injury.

Only UTP-

2.9

Warning

-TX or 10BASE-

-pair Ca

-Ray Products

contact our official dealer or INNOLUX Representative.

Keep equipment other than tho

appropriate system isolation.

In normal use, have a patient take a proper positioning for exposure. The

operator should operate the system in a place where safety from radiation is

ensured. The operator sho

the patient is in the exposure area and the operating area of the system

_____________________________________________________________

Software Precautions

_____________________________________________________________

Do not install additional software to the system. Do not uninstall any of the

preinstalled in the system. The system is preinstalled with the

appropriate software. If other so

uninstalled, various operational errors may result.

Source Software Contained in This Product

This product contains third party’s software that is made available as open

source software or free softwa

This software is provided “as is” with no warranty of any kind as to its

merchantability or fitness for any particular purpose.

If you would like to receive such source codes, please contact INNOLUX

dealer or the service representatives at the agency

purchased this product. (Please be noted that any inquiries concerning

the contents of source codes should be directed to original licensors of

open source software.)

_____________________________________________________________

ction Instructions

_____________________________________________________________

Do not use the following disinfectants or sterilize

se used for patients out of their reach to ensure

uld also make sure before exposure that no one but

ftware is installed or if the existing software is

from which you

rs at the time of disinfection,

2.10

Caution

software

Open-

re.

2.11 Disinfe

Warning

-Ray Products

performance and safety of the equipment cannot be

Chloric disinfectant which is strongly corrosive to metals and rubber parts.

Disinfectant whose uses on metals, plastics, and coating are forbidden

instructions supplied with the disinfectant.

Formalin gas and disinfectant sprays that may

Ultraviolet sterilizers

Disinfectant ethanol is recommended for disinfection. Carefully read the

instructions and cautions supplied with the disinfectant before use.

For details on the disinfectant, contact a INNOLUX dealer or th

representatives at the agency from which you purchased the disinfectant.

is not disinfected, it may lead secondary infection.

Be sure to disinfect with ethanol after use.

detector

_____________________________________________________________

Charging the Battery Pack

_____________________________________________________________

battery only by the back

battery is installed on Yushan flat panel detector or u

by INNOLUX Corporation.

instruction manual for the battery charger.

not charge the battery pack near fire or under strong sunsh

mechanisms are activated by a high temperature, the batter

cannot be charged. Also,

attery pack may be

reactions may occur inside the

overheat, emit smoke, explode or ignite.

get inside the equipment.

with ethanol for disinfection, etc. for each patient

up cable provided by INNOLUX when

se the battery charger

For details on operations, refer to the

ine. If the built

in protection mechanisms are damaged,

extremely high current and voltage, and

battery pack, causing it to

which the quality, assured.

according to the

Caution

If flat panel detector

Clean the flat panel

e service

to prevent infection.

2.12

Caution

Charging

provided

Do protection

the b

-in

y pack

if the built-

charged with

abnormal chemical

-Ray Products

To charge the battery pack, be sure to use the designated

the charging conditions specified by INNOLUX Corporation. If

battery pack is charged in

an specified, remodeled battery

ercharged or charg

chemical reactions may occur inside the batter

emit smoke, explode or ignite.

Immediately stop charging the battery pack, if charging is not completed within

time. Otherwise, the battery pack may overheat, emit smoke,

Do not use the flat panel

Do not use a faulty or broken battery charger or AC adapter.

_____________________________________________________________

Battery Pack Instructions

_____________________________________________________________

Battery pack requires regular checkup and replacement. Battery capacity

after a period of time.

If this equipment is not in use for while, store it with the battery pack removed.

removing the battery pack may cause malfunction.

used with the flat panel detector

Charge the battery pack only with the designated battery charger. If the battery

charged under the charging conditions (voltage, current and charging

from those specified by INNOLUX Corporation, the battery

smoke, ignite,

Store the battery pack in a cool and dark place. Recharge the stored battery

six months or every year. Otherwise a decrease in battery capacity

result.

battery charger and

other conditions (temperature or voltage/current

charger, etc.), the battery pack may

and abnormal

y pack, causing it to overheat,

. Do not use them in other

to observe

higher th be ov

the specified explode or ignite.

2.13

the

ed with extremely high current,

detector near the power cable.

Warning

begins to warm

Not

Caution

The battery pack is combinations.

pack is method) different pack may emit

pack every or other problems may

explode or leak fluid.

-Ray Products

Do not leave the removed battery pack in the car or other places exposed to high temperature. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid.

Use or store the battery pack only in the environmental conditions specified by INNOLUX. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid.

When disposing of the battery pack, consult our official dealer or INNOLUX Representative.

Do not disassemble or remodel the battery pack. The battery pack is equipped with built-in safety and protection mechanisms. If they are damaged, the battery pack may overheat, emit smoke, explode or ignite.

Be careful not to drop the battery pack. The patient may be injured. Do not touch the terminal of the battery pack directly. There is a risk of electric

shock. Do not connect the positive (+) and negative (-) terminals with a wire or any

metal object. Do not carry or store the battery pack together with metal objects such as

necklaces or hairpins. Otherwise, the battery pack may short-circuit and overcurrent may flow, causing the battery pack to overheat, emit smoke, explode or ignite. Metal objects such as necklaces or hairpins may also become hot.

Do not throw the battery pack into fire or expose it to excessive heat. Otherwise, its insulator may melt, its gas release vent or safety mechanisms may be damaged, and/or its electrolyte may catch fire, causing the battery pack to overheat, emit smoke, explode or ignite.

Do not use or leave the battery pack in a place where it is exposed to high temperature (60C or higher), such as fire or a heater. If the resin separator is damaged due to heat, the battery pack may short-circuit, causing it to overheat, emit smoke, explode or ignite.

Do not immerse the battery pack in water or seawater, and do not allow it to become wet. If the built-in protection mechanisms are damaged, the battery

pack may overheat, emit smoke, explode or ignite. Do not pierce the battery pack with a nail, hit it with a hammer, or step on it.

Otherwise, the battery pack may be damaged or deformed and short-circuit, causing it to overheat, emit smoke, explode or ignite.

Do not subject the battery pack to strong impact or throw it. If the built-in protection mechanisms are damaged, the battery pack may be charged with extremely high current and voltage, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.

Do not use an apparently damaged or deformed battery pack. Otherwise, the battery pack may overheat, emit smoke, explode or ignite.

Do not solder the battery pack directly. Otherwise, its insulator may melt, or its gas release vent or safety mechanisms may be damaged, causing the battery pack to overheat, emit smoke, explode or ignite.

Do not reverse the positive (+) and negative (-) terminals. Otherwise, the battery pack may be reverse-charged during charging. As a result, abnormal chemical reactions may occur inside the battery pack, or extremely high current may flow during discharging, causing it to overheat, emit smoke, explode or ignite.

The battery pack has a predetermined polarity. If you cannot connect the battery pack to the battery charger or other equipment, do not connect the battery pack forcefully. Make sure that the terminals are correctly oriented. If the battery pack is connected in reverse, it will be reverse-charged, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite.

Do not connect the battery pack to an electrical outlet or cigarette lighter socket in a car. Overcurrent may flow to the battery pack due to high voltage applied, causing the battery pack to overheat, emit smoke, explode or ignite.

Do not use the battery pack for equipment other than those specified. Otherwise, the guaranteed performance will be reduced and/or the service life will be shortened. Depending on the equipment to which the battery pack is connected, extremely high current may flow, causing the battery pack to be damaged, overheat, emit smoke, explode or ignite.

If the electrolyte leaked from the battery pack enters the eyes, do not rub them.

Wash the eyes immediately with

doctor. Otherwise, eye injury may result.

Do not use the battery pack in combination with a primary battery such as a dry

battery or other battery of a different capacity, type and/or brand. Otherwise,

ry pack may be overcharged during charging, and abnormal chemical

reactions may occur inside the battery pack, causing it to overheat, emit

smoke, explode or ignite.

Do not put the battery pack in a microwave oven or high

battery pack may be rapidly heated or damaged, causing it to

overheat, emit smoke, explode or ignite.

If the battery pack leaks or emits an unusual odor, remove it from fire

Otherwise, the leaked electrolyte may catch fire, causing the

y pack to overheat, emit smoke, explode or ignite.

If you notice an unusual odor, heat, discoloration, deformation or any other

abnormality during use, charging or storage, remove the battery pack from the

equipment or battery charger, and stop using it. O

may overheat, emit smoke,

Do not use the battery pack exposed to a strong magnetic field of an MRI

o not use the battery pack immersed in liquid.

Keep the battery away from fire. Avoid the action of

to disassemble the battery pack.

Use the designated chargers to charge the battery pack. Risk of explosion if

battery replaced by an incorrect type.

Dispose of used batteries according to the instructions.

____________________

Precautions

_____________________________________________________________

No modification of this equipment is allowed.

clean water such as tap water, and consult a

pressure container.

therwise, the battery pack

short circuit. Never attempt

_________________________________________

the batte

Otherwise, the

immediately.

batter

system, etc. D

exploder ignite.

2.14 Other

Warning

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Because this equipment is not explosion

explosive gases near the equipment.

Do not hit or drop the equipment. Otherwise, injury or damage to images, etc.

Be sure to inspect the system periodically.

To assure optimum performance of the equipment, it is necessary to

systematically perform maintenance and inspection. For information on

maintenance and inspection, contact our official dealer or INNOLUX

Do not perform maintenance and inspection while the equipment is used for a

ere the equipment is installed is responsible for its use and

maintenance. In addition, this equipment should not be used by persons other

than doctors or suitably trained staff.

Be careful not to expose the flat p

Although the flat panel

the prevention of water intrusion in the flat panel

is splashed with water, wipe off moisture and ensure that the flat

letely dry before use.

As the cables of the equipment are long, be careful not to entangle the cables

during use. Also, be careful not to trip over the cables. Falls could result in

Follow the specified procedure when turning off the equipment. Ot

flat panel detector could be damaged by thermal shock.

External equipment intended for connection to signal inputs, signal outputs or

other connectors shall comply with the relevant product standard e.g. IEC

1 or IEC 62368

Medical Electrical Equipment. In addition, all such combinations

shall comply with the safety requirements stated in the

general standard IEC 60601

complying with the leakage current requirements in IEC 60601

proof, do not use combustible and

ray without a subject.

conforms to IPX6, no warranty is given as to

. If the flat panel

ment and the IEC 60601

1, edition 3, clause 16. Any equipment not

1 shall be kept

Caution

may result.

Representative.

patient. The institution wh

detector panel detector is comp

injury.

60950-

anel detector to X-

detector

-1 for IT-equip

detector

herwise, the

-series for

Electrical Systems –

-Ray Products

– Medical

outside the patient environment i.e. at least 1.5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents.

Any person who connects external equipment to signal inputs, signal outputs or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative. _____________________________________________________________

2.15 Disposal of Waste

It is illegal to place the device in the trash. Please contact the qualified local recycling provides before disposing the device, The disposal procedure should comply with local law.

2.16 Product Labels

The information of each label can be found in this section and the corresponding location are also presented as the following figure. The following labels are adhered to the INNOLUX Yushan X-Ray Flat Panel Detector.

2.16.1 Identification Label

Yushan V14C

Yushan V14G

2.16.2 Battery Polarity Label

2.16.3 Battery Label

2.16.4 Packing Carton Label

2.16.5 Adapter Specification Label

2.16.6 Safety Symbols

The following safety symbols are used in the labels or on its body.

o C

Yushan FPD can be operated either in wireless connection mode or wired

connection mode. When using wired mode, back

provide the link from FPD to network switch hub or to PC.

up cable to the adapter provid

to operate or charging its battery. If the ad

_____________________________________________________________

up cable

it may result in electric shock or

_____________________________________________________________

onfiguration

up cable is necessary to

User can also

ed by INNOLUX to give the power

not connected, FPD will be

when in wireless mode

malfunction of the equipment

Chapter 3

3.1 How t

connect back-

System C

onnect FPD

apter is

Caution

Do not touch the back-

otherwise

connector of Yushan

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3.2 Unit Names and the Functions

3.2.1 Flat Panel Detector

Unit names and the functions of the Yushan FPD are described below.

Back

up cable

⎓

3.2.2 Accessories

Description: A cable which one side connects the flat panel detector and the

other side spilt into two cable, one is RJ45 connector to connect with ethernet port, and the other side is DC Jack 5.5x2.5 to connect with the output of AC/DC adapter. Cable length: 2.5m

Adapter

Description: Medical grade AC/DC adapter which is used to provide power

either to detector or use to charge the battery installed on FPD.

- Input : 100-250V ~ 1.5-0.75A 50-60Hz

- Output : 24V

2.5A

- Length : 1.5M

Battery (Optional)

Description: Rechargable Li-Ion battery designed for Yushan FPD.

- Capacity: 4212 mAh

- Rating voltage: 11.4V, TYP:4212mAh/48Wh

- Weight: ~260g

- UL certified Safety

Power Cord

Description: Connection between AC inlet and adapter input.

- PLUG : 6A/250V, CONNECTOR: 10A/250V

- Length : 3M

- PLUG : 10A/125V, CONNECTOR: 10A/125V

- Length : 2.5M

_____________________________________________________________

Note:

Every accessory can’t be sale or used as an independent product, which is not compatible with other devices. Therefore, every provided accessory is identified to have not received prior 510(k) clearance.

Do not use parts or accessories which are not certified by INNOLUX Corporation or not approved by CE or FDA. _____________________________________________________________

3.3 LED indicators

4 LED indicator are on the side of Yushan series FPD.

The behavior and the relations to the FPD status are described in the table below.

Chapter 4 Basic Operation

4.1 Preparing the Flat Panel Detector

This section describes how to prepare the flat panel detector.

4.1.1 Type of Flat Panel Detector

Yushan V14C, Yushan V14G

4.1.2 Number of the Connectable Flat Panel Detector

Up to 5 panels can connect to system at the same time.

4.1.3 Connecting/Disconnecting the Flat Panel Detector

_____________________________________________________________

Charging the Battery Pack for the Flat Panel

Use the battery charger recommended by INNOLUX Corporation.

to the instruction manual for the battery charger.

Installing/Removing the Battery Pack for the Flat

Follow the procedure below to install/remove the bat

When installing/removing the battery pack, place the flat panel

Do not remove the battery pack until a processed image appears in the

window of the image processing unit after the exposure.

Do not place the connector

on a hard surface such as

the edge of a bed.

tery pack for the flat panel

Do not raise the flat panel

sensor by

connector

Caution

4.1.4 Detector

on operations, refer

4.1.5 Panel Detector

Make sure that the connector does not protrude from the edge of a bed.

holding only the

For details

detector. detector on a flat place.

-Ray Products

Remove the battery pack

Step Slide the arrow switch toward right side and hold it.

Step Pick up the edge of battery by finger, then lift it.

Install the battery pack

Step Following the picture and install the battery.

Step Push the battery pack and make sure the battery is tightly installed.

4.1.6 LED Indicator to show battery capacity

By short press LED at any time, even when power is off. LED will show current remaining capacity. If the main battery is not exist, it will show the second battery capacity by flashing light.

4.2 Detector Connection

Yushan detector can be connected to system either by wireless or by wire cable.Yushan FPD use Dynamic Host Configuration Protocol (DHCP) to assign IP address automatically.

4.2.1 Wire connection

The default address of Yushan is 192.168.11.100. User need to set the computer to the same domain as Yushan. First, open the IPV4 of computer's local network management interface, and change the IP address to

192.168.11.1 and subnet mask to 255.255.255.0.

After connection established, open Cmd.exe and enter ‘ping 192.168.11.100’ then press enter to check the network. If success, there is a reply from FPD as below.

4.2.2 Wireless connection

SDK command is used to setup SSID and password of wireless access point. This setup to FPD need to be done first before wireless connection.

Users can set client mode parameters through the software interface. Choose wireless in configuration interface.

Choose the “Client”.

Set the SSID and pass phrase of AP to be connected to the product.

4.2.3 AP mode connection

Users can set AP mode parameters through the software interface. Choose wireless in configuration interface.

Choose the “AP”.

Set the SSID and pass phrase of product.

User needs to set the computer to the same domain as Yushan (Wifi). First, open the IPV4 of computer's local network management interface, and change the IP address to 192.168.11.1 and subnet mask to 255.255. 255.0.

4.3 Starting Up and Shutting Down the Yushan FPD

This section explains how to start up and shut down the Yushan.

4.3.1 Starting Up the Yushan

Press the power button for more than 2 second to start the FPD.

1. Make sure that the power LED light in green.

2. Wait Status LED stop flashing

3. Wait Link LED light in green

4. Wait Status LED light in green (ready for exposure)

4.3.2 Overview of User Interface

- Discover: The area is used to list all FPD those are discovered and

reachable.

- Operations: The tool bar contains different exposure mode.

Message: The area is

Diagnosis: The area lists several diagnostic messages of FPD that is

currently connected.

Image List: The area lists the images created by exposure operations.

Search and connect FPD

all reachable FPDs

Expand the selected entry of the list, and select connection by Ethernet or Wifi.

Then click 2 to connect the specified FPD. Note: Please make sure the IP of

Host PC and the selected connection is in the same local area network.

used to display important message to users.

4.3.3

Click 1 to discover

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4.3.3.1 Wireless connection

Expand the selected entry of the list, and select connection by Ethernet. Then click 2 to connect the specified FPD. Note: Please make sure the host PC is

connected to the specified AP.

After establishing the connection, you can check the diagnosis field on the right to confirm the information of Yushan products. The message appears to indicate a successful connection.

After connection is established, you can use 3 to disconnect the FPD. Note: Connecting to other FPD disconnect the currently connected FPD automatically

.4 Enter the operation and select the mode

Enter operation mode / Exit operation mode:

The FPD must enter operation mode before take

After FPD enters operations mode, user can perform several exposure mode.

or dark

4.3

exposure

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image.

4.3.5 Performing an Exposure and Image Acquistion

When performing an exposure, make sure that the STATUS LED light in green and not flashing. Otherwise image may loss.

4.3.5.1 AED one shot mode

- After selecting the AED one shot mode, press Start.

- When FPD is in AED one shot mode, it returns to operation mode after

each X-Ray exposure is detected. User can use Stop to exit AED one

shot mode before X-Ray exposure is detected.

- If the X-Ray exposure is successfully detected by FPD, the newly created

image is listed in the Image List area. This utility application will try to

download the image to local storage, and the file name is the image key.

- If the working directory is not specified, the images will be saved in the

folder as the utility.

4.3.5.2 Software sync mode (Emulation of two-stage exposure button)

- This group only serves as emulation of two-stage exposure button, and

verifies the API functionality.

- After selecting the Software sync mode, press Start.

- When performing an exposure, make sure that the STATUS LED light in

green and not flashing.

4.3.5.3 AED repeat mode

- After selecting the AED repeat mode, press Start.

- When FPD is in AED repeat mode, it stays in AED repeat mode after

each X-Ray exposure is detected. User can use Stop to exit AED repeat

mode.

- The utility doesn’t not download the exposure image after each exposure,

it only updates the information of the newly created exposure image in the

Image List area.

The steps of downloading exposure images are

AED repeat

Use the Get Image List to update the Image List (Optional)

Select the image and click Download Raw button

a. Exit the b. c.

mode

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4.3.5.4 Other Operations

- Discharge: Discharge panel.

- Acquisition: Discharge panel and acquire image immediately.

- Reset operation mode: If errors occur in the exposure workflow, user must

use this button to reset.

4.3.6 Download image from FPD

- Auto download The software has an automatic download function, as long as the automatic download is checked, the image can be automatically downloaded in modes other than AED repeat mode.

- Image ready

The image data is first stored in the DDR SDRAM and then transferred to the PC. When the status of image has been show “ready”, it means the images is already stored in the DDR SDRAM.

- Image download OK

When the status of image has been show “OK”, it means the images is already stored in the PC.

- Archive after continuous image taking If the automatic download function is not checked, the image will be stored in the DDR SDRAM. First, press (3) to list all the information of the image, and then press the arrow of (1) to output the original image to the PC. In addition, if there is an image with offset set at the beginning of the exposure, press the (2) arrow to output the offset image to the PC.

4.3.7 Shutting Down the Yushan

Press the power button for more than 2 second to shut down the FPD.

4.4 Correction procedure

4.4.1 Collect images

When the program is executed, the corrected images are collected in sequence. First, 16 dark images were collected, then the X-ray energy was set to 20 uGy and the X ray window and offset window were both set to 200 ms and collected 16 times. The LSB average of the light image is obtained. It needs to fall within the range of 15,000 to 20,000. According to the above image, the offset map (D) and the gain map (G) are calculated. And use the following algorithm to correct for raw images.

C = corrected image

R = raw image

F = flat field image

D = dark field or dark frame

m = image-averaged value of (F-D)

G = Gain =

4.4.2 Correction process

First get 16 dark images and 16 light images, sort and store the images in the same folder, and create another folder named "calib".And store the image to be corrected in the same folder and fill in the name of the folder. Click “ Noise ”: The “mode” represents the level of noise. The “ ()” represents the number of pixels.

Click “Gen Map”: Will output the map to be calculated

Click “Correction” The Detector has been successfully corrected if a “correction of all raw images is complete” appears in the windows as seen in the figure.

4.4.3 Storage of calibration data

calibration data can be stored inside Yushan. Users can update or

get calibration data for the product.

After selecting the class of the map, click “File to send”. Click on the file to be

updated to the inside of the product.

complete

_____________________________________________________________

These actions are carried out by Authorized Personnels not End Users.

_____________________________________________________________

10 sets of

Click “Set” and

Caution

the update.

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Maintenance

.1 Daily User Inspection and

Maintenance

During maintenance and inspection, strictly observe precautions contained in

Chapter 2 Safety and Regulatory

.1.1 Periodical Inspection

emove any dirt or dust accumulated in each part of the

equipment using a vacuum cleaner or air duster, clean each part

with a slightly moistened soft cloth and then wipe off any moisture

See “3.2 Unit Names and the Functions”.

Authorized Personnel

There are no parts/components that needed to be replaced by Innolux or any

_____________________________________________________________

Be sure to turn off the power before

Ensure sufficient space when cleaning the equipment on a table, etc

_____________________________________________________________

Daily Inspection and

” in this manual for you to use the

cleaning each part of the device.

Chapter

“ under best conditions.

device

End User

Every

with a dry cloth.

authorized personnel.

Caution

Three Months

-Ray Products

Chapter 6 Troubleshooting

- In case of smoke, fire, abnormal high temperature, remove battery and

power supply and turn off detector imediately.

- In case of yellow error LED on, it may trigger the impact. Please read the

manual to release the status and restart the power; if the yellow light

cannot be removed, contact INNOLUX service engineer or local

representative

- In case of abnormal image, calibrate detector by standard method.

Contact INNOLUX service engineer or local representative if error is not

removed by calibration.

- Other technical issue, contact INNOLUX service engineer or local

representative.

- When Yushan cannot be turned on, please check if the battery has power

or if the DC power supply is connected.

- When the software shows that the network can't connect, please confirm

the signal of Yushan first. If it is wireless network, the third light needs to

be solid green to indicate that it has been connected. If the green light

flashes, it means that Yushan is not connected. At this time, please check

the network settings of the environment and the computer, and have

successfully connected.

Appendix A Specifications of FPD

A.1 Specifications

Specifications of the Yushan are shown below.

A.1.1 Reduced Equivalent

Peak reduced equivalent on the front panel of the flat panel detector: 0.57 mmAl

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

The DC power supply to Yushan FPD is delivered with its AC/DC adapter.

Item Min Typ. Max unit

Input Voltage Range 80 264 VAC Nominal Input Frequency Input Frequency

50 60 hz

47 63 hz Range Output voltage 24 VDC Output current 2.5 A Input connector (AC inlet) Output connector type DC JACK 5525

Standard IEC

62320-C14

A.1.3 Power Supply to Battery Charger

A 2-slot battery charger is provided along with the Yushan V14C/V14G. The battery charger is delivered with its AC/DC adapter which is the same as

A.1.2.

A.1.4 Power Consumption and Battery Specification

Item Specification (typical) Unit

Power (Operating) 16 W Power (Stand-by) 10 W Battery voltage 11.4 V Battery capacity 4212 mAh Battery operating time in stand-by mode Battery operating time in Operating mode Charging time (by cable) 4 hours

6 hours

4 hours

A.1.5 Environmental Conditions

A.1.5.1 Storage and Transport

Item Min Max

Temperature Humidity1 10% 90% Pressure2 700mBar 1060mBar

Battery storage temperature3

- note1: Non-condensing

- note2: 700mBar is equivalant to 3000m in altitude

-10°C 50°C

- note3: Less than 1 month at 50°C

A.1.5.2 Functional Operating

Within the range of functional operating conditions, the Yushan V14C, Yushan V14G are safe and functional.

Functional means that the detector is able to deliver an image, whereas the image quality and electro-optical performances are not guaranteed. It also

means that, except if mentioned explicitly, any perturbation occurring within

conditions are reversible and not existing anymore when the detector is

turned back within the performance operating conditions.

Weight (local load on 4 cm

200 Hz / 3

Drop height (the reversibility

not

guaranteed for this item)

.3 Performance

Performance is guaranteed in the

Distance to calibration

Weight (local load on 4 cm

200 Hz / 3

V14C

performance

after a drop test of following

_____________________________________________________________

80%

1060mBar

300 kg

120 kg

2 g

70 cm

80%

1060mBar

+12

300 kg

120 kg

2 g

70 cm

those

Item

Temperature Humidity Pressure Weight (uniform load)

diameter) Vibrations (10 axis )

to full performance is

A.1.5

Item

Min Typ.

5°C 25°C 15% 700mBar 1013mBar

Operating

operating range below.

Min. Typ.

Max

°C

Max.

Temperature Humidity Pressure

temperature Weight (uniform load)

diameter disc) Vibrations (10 axis ) Drop (The Yushanremains at full

height)

15°C 25°C 15% 700mBar 1013mBar

-12°C 0°C

°C

Caution

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When the flat panel detector is used in high temperature condition for long period of time, it may cause image artifacts and/or failure of the device. _____________________________________________________________

A.1.6 Image Performance

Each flat panel detector complies with IEC 62220-1 (MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES) as a general X-ray radiography equipment.

To ensure optimal image quality, it is recommended that you do not use the flat panel detector near devices (motor, transformer, switching supply, etc.) that generate electromagnetic noise.

V14C (CsI Version) Performance at RQA5

Item Min Typ. Max unit

MTF @ 1 lp / mm 0.62 0.69 0.76 MTF @ 2 lp / mm 0.35 0.39 0.43 MTF @ 3 lp / mm 0.18 0.22 0.26 DQE @ 0 lp / mm 0.45 0.51 0.56 DQE @ 1 lp / mm 0.43 0.48 0.53 DQE @ 2 lp / mm 0.35 0.39 0.44 DQE @ 3 lp / mm 0.23 0.29 0.35 Sensitivity @2uGy 488 574 660 LSB/uGy Dark noise 4.5 6 LSB Maximun linear dose 75 88 101 uGy Maximun clipping dose

100 120 140 uGy

V14G (GOS Version) Performance at RQA5

Item Min Typ. Max unit

MTF @ 1 lp / mm 0.47 0.52 0.57 MTF @ 2 lp / mm 0.20 0.23 0.26 MTF @ 3 lp / mm 0.06 0.11 0.16 DQE @ 0 lp / mm 0.27 0.31 0.35 DQE @ 1 lp / mm 0.23 0.27 0.31 DQE @ 2 lp / mm 0.11 0.16 0.21

DQE @ 3 lp / mm 0.04 0.09 0.14 Sensitivity @2uGy 503 592 681 LSB/uGy Dark noise 7.9 10 LSB Maximun linear dose 75 88 101 uGy Maximun clipping

100 120 140 uGy

dose

A.1.7 Radio Waves

Wireless specifications for the flat panel detector and the access point are as follows.

Item Specification

Wireless specification IEEE802.11 ac / a/g/n

Transmit frequency 5.2, 5.3, 5.6, 2.4 GHz

Antenna 2

Date rate 866Mbps (802.11ac)

Authentication WPA/WPA2-PSK

AP mode Work only in 2.4Ghz

- Note: Use of 2.4GHz: ch11 for N.America, ch13 for Europe (ETSI)

- Transmit frequencies available vary, depending on the country.

- Radio waves available outdoors vary, depending on the country where the

system is used.

- When the Yushan and any other wireless equipment are operating on the same frequency channel in a hospital, it may take time to show an image on the image processing unit monitor.

This equipment uses wireless LAN (WLAN) radios for transferring images. The WLAN power levels and antenna configurations have been tested and certified compliant through specific absorption rate (SAR) limit set by FCC testing with separations as small as 0 cm between the panel antennas and human tissue.

A.1.8 Reliability and Lifetime

Item Specification unit

X-ray hardness 100 Gy

Expect service life 10 years

A.2 External View and Weight

Item Width Length (mm) Height (mm) Weight (Kg)

Yushan V14C 460 383 15 2.7 Yushan V14G 460 383 15 2.7

Appendix B Electromagnetic

Compatibility

B.1 Yushan FPD

This equipment has been tested and found to comply with the limits for medical

devices to the IEC 60601

These limits are designed to provide reasonable protection against harmful

interference in a typical

This equipment generates, uses and can radiate radio frequency energy and, if

not installed and used in accordance with the instructions, may cause harmful

interference to other devices in the vicinity.

However, there is no guarantee

If this equipment does cause harmful interference to other devices, which can

be determined by tuning the equipment off and on, the user is encouraged to

try to correct the interference by one

Reorient or relocate the receiving device.

Increase the separation between the equipment.

Connect the equipment into an outlet on a circuit different from that to

which the other device(s) are connected.

nnot be solved with the above measures, stop using this

equipment and consult the manufacturer, our official dealer or INNOLUX

Representative for help.

_____________________________________________________________

Do not place devices generating

If a device(s) other than those specified is connected, predetermined EMC

performance can not be guaranteed.

_____________________________________________________________

that interference will not occur in a particular

or more of the following measures:

electromagnetic wave near this equipment.

(EMC)

-1-2:2014/EN 60601-1-2:2015.

medical installation.

installation.

If the problem ca

Warning

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

1. Medical electrical equipment needs special precautions regarding EMC and

needs to be installed and put into service according to the EMC information provided in the accompanying documents.

2. Portable and mobile RF communications equipment can affect medical

electrical equipment.

3. Information regarding the cable affecting EMC is as follows.

Name Connection Maximum

length

Network cable

Power cord From adaptor to AC

4. The use of accessories, transducers and cables other than those specified,

with the exception of transducers and cables sold by INNOLUX Corporation as replacement parts for internal components, may result in increased emissions or decreased immunity of the Yushan.

5. The Yushan should not be used adjacent to or stacked with other

equipment. If adjacent or stacked use is necessary, the Yushan FPD should be observed

Extend Back-up cable to PC or network switch.

outlet

20m Cat 5e or more

Use a hospital grade power cord

General specification

UTP type and straight cable

to verify normal operation in the configuration in which it will be used.

6. Basic performance of the equipment and the system

After image data are acquired from the flat panel detector, offset data correction is performed by flat pane detector and then the image is send to DR system via wireless connection or wired connection.

7. Test items (Tables 1 to 4)

Waiting for EMC report.

Appendix C Radio Frequency (RF) Compliance Information

Federal Communications Commission (FCC) Statement

You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on a circuit different from that to

which the receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

1) this device may not cause harmful interference and

2) this device must accept any interference received, including interference

that may cause undesired operation of the device.

FCC RF Radiation Exposure Statement:

1. This Transmitter must not be co-located or operating in conjunction with any

other antenna or transmitter.

2. This equipment complies with RF radiation exposure limits set forth for an

uncontrolled environment. This equipment should be installed and operated

with a minimum distance of 0 cm between the radiator and your body.

Innolux 000001 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual