000001 Flat Panel Detector Users Manual

Company: InnoCare Optoelectronics Corp

FCC ID: 2AS4N000001

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Yushan Yushan Series X-Ray Flat Panel Dete ay Flat Panel Detector tor Operation Operation Manual Corp. InnoCare Optoelectronics Corp InnoCare Optoelectronics InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 1 Radiologist or any other practitioners licensed Radiologist or any other practitioners licensed should ensure that they have should ensure that they have adequate knowledge of the operation prior using the Yushan X-Ray Flat Panel adequate knowledge of the operation prior using the Ray Flat Panel Detector. This Operation Manual should be studied and understood before proceeding Manual should be studied and understood before proceeding Manual should be studied and understood before proceeding erate the equipment on patients; it describes details on how to operate to operate the equipment on patients; it describes deta on how to operate the Yushan X-Ray Flat Panel Detector Ray Flat Panel Detector and cautions to be observed when and cautions to be observed when operating it. After reading this manual, store it nearby the Detector so that you can see it whenever necessary so that you can see it whenever necessary. nual, store it nearby the Yushan X-Ray Flat Panel Ray Flat Panel Federal Law restricts this device to sale by or on the order of a

"Caution: Federal 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 radiologist or any other practitioners licensed by the law of the state in whi radiologist or any other practitioners licensed by the law of the state in whi that person practices to use or order the use of the device. that person practices to use or order the use of the device."

_____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution This Operation Manual contains confidential and proprietary information of the Manual contains confidential and proprietary information of the Manual contains confidential and proprietary information of the Manufacturer. Before using the device, please check local regulations. If any local legislation Before using the device, p lease check local regulations. If any local legislation is violated, use cannot be authorized. is violated, use cannot be authorized. If additional training or material for training is needed, please directly If additional training or material for training is needed, please directly If additional training or material for training is needed, please directly contact our official dealer or InnoCare _____________________________________________________________ ______________________________ _______________________________ nnoCare Representative. Trademarks Company names described in this manual are the trademarks or registered Company names described in this manual are the trademarks or registered Company names described in this manual are the trademarks or registered trademarks of InnoCare Optoelectronics Corp. InnoCare Optoelectronics Corp. or their respective holders. or their respective holders. Windows is the registered trademark of US Microsoft Corporation i Windows is the registered trademark of US Microsoft Corporation i Windows is the registered trademark of US Microsoft Corporation in the U.S.A. and other countries. Copyright 2019 InnoCare Optoelectronics Corp InnoCare Optoelectronics Corporation. All rights reserved. All rights reserved. Document Number: YS-

-OM-01 Version: A4 Issued date: 2019/08/23 23 InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 2 Table of Content Chapter 1 Introduction ............................................................................................. 6 Product Introduction ............................................................................ 7 1.1 Product Series ....................................................................................... 7 1.2 Product Indications for Use ............................................................... 7 1.3 Product Significant Performance Characteristics ....................... 7 1.4 Product Intended Patient Population .............................................. 8 1.5 Product Intended Part of the body or type of tissue applied to 1.6 or interacted with .............................................................................................. 8 Product Intended user profile ............................................................ 9 1.7 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 Warnings for Pediatric Use.................................................................. 22 2.15 Other Precautions .................................................................................. 23 2.16 Disposal of Waste .................................................................................. 24 2.17 Product Labels ........................................................................................ 24 2.17.1 Identification Label ..................................................................... 25 2.17.2 Battery Polarity Label ................................................................ 26 2.17.3 Battery Label ................................................................................ 27 2.17.4 Packing Carton Label ................................................................ 27 InnoCare Optoelectronics Corporaon :-Ray Products 3 2.17.5 Adapter Specification Label ..................................................... 27 2.17.6 Safety Symbols ........................................................................... 28 3.1 How to Connect FPD ............................................................................... 29 3.2 Unit Names and the Functions ............................................................. 30 3.2.1 Flat Panel Detector ....................................................................... 30 3.2.2 Accessories .................................................................................... 31 3.3 LED indicators ........................................................................................... 34 Chapter 4 Basic Operation ................................................................................... 35 4.1 Preparing the Flat Panel Detector ........................................................ 35 4.1.1 Type of Flat Panel Detector ........................................................ 35 4.1.2 Number of the Connectable Flat Panel Detector .................. 35 4.1.3 Connecting/Disconnecting the Flat Panel Detector ............ 35 4.1.4 Charging the Battery Pack for the Flat Panel Detector ....... 36 4.1.5 Installing/Removing the Battery Pack for the Flat Panel Detector ..................................................................................................... 36 4.1.6 LED Indicator to show battery capacity .................................. 37 4.2 Detector Connection................................................................................ 38 4.2.1 Wire connection ............................................................................ 38 4.2.2 Wireless connection ..................................................................... 39 4.2.3 AP mode connection .................................................................... 40 4.3 Starting Up and Shutting Down the Yushan FPD ............................ 43 4.3.1 Starting Up the Yushan ............................................................... 43 4.3.2 Overview of User Interface ......................................................... 44 4.3.3 Search and connect FPD ............................................................ 45 4.3.4 Enter the operation and select the mode ............................... 46 4.3.5 Performing an Exposure and Image Acquistion .................. 47 4.3.6 Download image from FPD ......................................................... 51 4.3.7 Shutting Down the Yushan ......................................................... 52 4.4 Guidelines for Pediatric Applications............................................ 53 4.5 Correction procedure .............................................................................. 55 4.5.1 Collect images ............................................................................... 55 4.5.2 Correction process ....................................................................... 56 4.5.3 Storage of calibration data ......................................................... 58 4.5.4 Standard Configuration ......................................................... 59 5.1 Daily User Inspection and Maintenance ............................................. 61 5.1.1 Periodical Inspection ................................................................... 61 Chapter 6 Troubleshooting .................................................................................. 62 Appendix A Specifications of FPD ..................................................................... 63 InnoCare Optoelectronics Corporaon :-Ray Products 4 A.1 Specifications ........................................................................................... 63 A.1.1 Reduced Equivalent ..................................................................... 63 A.1.2 Power Supply Conditions when Using Back-up Cable ...... 63 A.1.3 Power Supply to Battery Charger ............................................ 64 A.1.4 Power Consumption and Battery Specification ................... 64 A.1.5 Environmental Conditions ......................................................... 64 A.1.6 Image Performance ...................................................................... 66 A.1.7 Radio Waves .................................................................................. 68 A.1.8 Reliability and Lifetime ............................................................... 68 Appendix B Electromagnetic Compatibility (EMC) ........................................ 70 B.1 Yushan FPD ............................................................................................... 70 B.2 Further Information for IEC 60601-1-2 (EN 60601-1-2) ................... 71 Appendix C Radio Frequency (RF) Compliance Information ...................... 78 InnoCare Optoelectronics Corporaon :-Ray Products 5 Chapter 1 Chapter 1 Introduction This manual is intended to provide the operator with an overview of the This manual is intended to provide the operator with an overview of the This manual is intended to provide the operator with an overview of the operation and safety requirements for the operation and safety requirements for the Yushan X-Ray Flat Panel Detector. Ray Flat Panel Detector. This manual is not intended to provide instructions on actual treatment s not intended to provide instructions on actual treatment s not intended to provide instructions on actual treatment procedures and it is expected that users should have official procedures and it is expected that users should have official radiologist or any radiologist or any license prior to using the device. The Manufacturer and other practitioners license prior to using the

. The Manufacturer and Distribution organization assume no liability through the use of the device Distribution organization assume no liab ugh the use of the device. All care has been taken in the preparation and checking of this manual All care has been taken in the preparation and checking of this manual 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 however there is no guarantee provided that all information is correct. The however there is no guarantee provided that all information is correct. The information provided in this manual is subject to change without notice. information provided in this manual is subject to change without notice. information provided in this manual is subject to change without notice. Only CE or FDA approved or authorized Only CE or FDA approved or authorized accessories may be used in this accessories may be used in this device. The Manufacturer and Distribution organization shall not be held liable

. The Manufacturer and Distribution organization shall not be held liable

. The Manufacturer and Distribution organization shall not be held liable or responsible for damages or injury caused as a result of or responsible for damages or injury caused as a result of using non using non-approved Installation may only be conducted by authorized service accessories. Installation m ay only be conducted by authorized service Some maintenance and service work also must be carried out by personal. Some maintenance and service work must be carried out by authorized service agents and only those procedures outlined in the operator authorized service agents and only those procedures outlined in the operator authorized service agents and only those procedures outlined in the operator and service manual are allowed. Any service work carried out by and service manual are allowed. Any service work carried out by and service manual are allowed. Any service work carried out by unauthorized person will void all warranties. No circuit diagrams or component part lists are person will void all warranties. No circuit diagrams or component part lists are person will void all warranties. No circuit diagrams or component part lists are to be provided for this device be provided for this device. If you require technical documentation that is not

. If you require technical documentation that is not provided in this manual then please contact the manufacturer or your local provided in this manual then please contact the manufacturer or your local provided in this manual then please contact the manufacturer or your local distributor in writing with your reasons for wanting them and then a copy of the ributor in writing with your reasons for wanting them and then a copy of the ributor in writing with your reasons for wanting them and then a copy of the service manual may be provided. Before using the Yushan X-Ray Flat Panel service manual may be provided. Before using the Ray Flat Panel Detector, the operator should read this manual carefully and pay particular the operator should read this manual carefully and pay particular the operator should read this manual carefully and pay particular attention to the sections of Safety, Operation and Maintenance. attention to the sections of S ________________________________________ ____________________________________________________________ _____________________ Caution InnoCare Optoelectronics Corp. InnoCare Optoelectronics Corp. shall not be liable for malfunctions and shall not be liable for malfunctions and damages resulting from use under environment conditions outside the range of damages resulting from use under environment conditions outside the range of damages resulting from use under environment conditions outside the range of installation using conditions sing conditions sing conditions installation installation environment, etc. contained in this manual. environment, etc. contained in this manual. this product such as power supply, this product such as power supply, this product such as power supply, for for for InnoCare Optoelectronics Corp. InnoCare Optoelectronics Corp. shall not be liable for malfunctions and shall not be liable for malfunctions and damages resulting from natural disasters such as fires, earthquakes, flo damages resulting from natural disasters such as fires, earthquakes, flo damages resulting from natural disasters such as fires, earthquakes, floods, lightning, etc. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 6 1.1 Product Introduction 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 Yushan V14G Yushan V17C Yushan V17G Glass version 14x 17 FPD with CsI Glass version 14x 17 FPD with GOS Glass version 17x 17 FPD with CsI Glass version 17x 17 FPD with GOS 1.3 Product Indications for Use The Wireless/Wired 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 wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. 1.4 Product Significant Performance Characteristics Items Characteristics Image resolution(V14C/V14G) Image resolution (V17C/V17G) Data MTF (Modulation transfer function) (Typical) CsI GOS 2500x3052 3072x3072 16 bit data 0.69 @ 1 lp/mm 0.39 @ 2 lp/mm 0.22 @ 3 lp/mm 0.52 @ 1 lp/mm InnoCare Optoelectronics Corporaon :-Ray Products 7 DQE (Detector quantum efficiency) (Typical) Maximum linear dose (Typical) Sensitivity (Typical) Dark noise (Typical) Lag 0.23 @ 2 lp/mm 0.11 @ 3 lp/mm 0.51 @ 0.5 lp/mm 0.48 @ 1 lp/mm 0.39 @ 2 lp/mm 0.29 @ 3 lp/mm 0.31 @ 0.5 lp/mm 0.27 @ 1 lp/mm 0.16 @ 2 lp/mm 0.09 @ 3 lp/mm 88 uGy 574 lsb/uGy 592 lsb/uGy 4.5 LSB 7.9 LSB

<0.5% after 1 minute CsI GOS CsI GOS CsI GOS 1.5 Product Intended Patient Population Considerations Age Height Weight Health Nationality Sex Requirement Description

- Not restricted

The uniform load of the device is 300kg The local load on 4 cm diameter of the device is 120kg.

*Note: Please evaluate the patients condition before using.

- Not restricted

- Multiple

- 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 InnoCare Optoelectronics Corporaon :-Ray Products 8 1.7 Product Intended user profile Considerations Education Minimum Maximum Knowledge Minimum Maximum Minimum Language Understanding Maximum Experience Minimum Maximum Requirement Description

- Graduate of radiology college

- No maximum

- Read and understand 'westernized Arabic' numerals when written in Arial font

- Can distinguish of human body

- Understands hygiene

- No maximum

- Understand the operation manual that Local language is writing in English Physician or legally certified operator

- 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 Frequency of use Location Mobility Condition

- 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

- Reusable

1day: 200 shot In hospital environment Portable ME equipment to be used on a patient InnoCare Optoelectronics Corporaon :-Ray Products 9 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 InnoCare 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 Yushan practitioners to attend organized meetings, workshops, seminars, and conferences on use of X-Ray Flat Panel Detector. _____________________________________________________________ InnoCare Optoelectronics Corporaon :-Ray Products 10 Chapter 2 Safety and Regulatory This 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 FCC part15 European Medical Devices Directive (93/42/EEC) EN ISO 13485:2016 EN ISO 14971:2012 EN 60601-1: 2006+A1: 2013 ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 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

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

- RED Directive (2014/53/EU)

- RoHS Directive (2011/65/EU) InnoCare Optoelectronics Corporaon :-Ray Products 11 2.1.2 Classification Classification Type of protection against electrical shock: Class I Equipment

Type of protection against electrical shock: Class I Equipment Type of protection against electrical shock: Class I Equipment Degree of protection against electrical shock: Type B Equipment

- Degree of protection a pment

- Degree of protection against harmful ingress of water: IPX6 Degree of protection against harmful ingress of water: IPX6 Degree of protection against harmful ingress of water: IPX6 (An IPX6 rating does not indicate compliance with, and the detectors have not been rating does not indicate compliance with, and the detectors have not been rating does not indicate compliance with, and the detectors have not been tested for compliance with, any other IPX_ ratings. tested for compliance with, any other IPX_ ratings.) Degree of safety of application in the presence of a flammable anesthetics

- Degree of safety of application in the presence of a f lammable anesthetics mixture with air or with oxygen or nitrous oxide: Equipment not suitable for mixture with air or with oxygen or nitrous oxide: Equipment not suitable for mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetics mixture with air or with use in the presence of a flammable anesthetics mixture with air or with use in the presence of a flammable anesthetics mixture with air or with oxygen or nitrous oxide. oxygen or nitrous oxide. 2.2 Contraindications 2.2 Contraindications No contraindications present. No contraindications present. 2.3 Power Supply Hazard Supply Hazard _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning The power supply to the Yushan is AC 100 to 240V. The power supply to the Yushan is AC 100 to 240V. To avoid electric shocks, users should always take the following precautions:

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

- Do not open any covers when it is not nec Do not open any covers when it is not necessary. Install the equipment in a location where it will not be exposed to water.

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

- Check that the equipment is securely earthed. Check that the equipment is securely earthed.

- Check that all of the cables are completely and securely connected. Check that all of the cables are completely and securely connected. Check that all of the cables are completely and securely connected. Keep the control cabinet out of reach of patients.

Keep the control cabinet out of reach of patients. _____________________________________________________________ _____________________________________________________ _____________________________________________________ Electric Shock Hazard 2.4 Electric S _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 12 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 its cable becomes overloaded. Otherwise, the cable may be damaged, causing fire or electric shock. if

- 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 13 InnoCare Optoelectronics Corporaon :-Ray Products packs are not attached, an electric shock may result. are not attached, an electric shock may result. Make sure to use the optional parts and accessories Make sure to use the optional parts and accessories provided by InnoCare provided by InnoCare. Failure to use the optional parts and accessories recommended by us may Failure to use the optional parts and accessories recommended by us may Failure to use the optional parts and accessories recommended by us may result in damage to the equipment and/or electric shock and injury. result in damage to the equipment and/or electric shock and in jury. Keep the equipment away from patients body fluids, chemicals, water, etc. Keep the equipment away from patients body fluids, chemicals, water, etc. Keep the equipment away from patients body fluids, chemicals, water, etc. Otherwise, it may be damaged, causing fire or electric shock. If necessary, Otherwise, it may be damaged, causing fire or electric shock. If necessary, Otherwise, it may be damaged, causing fire or electric shock. If necessary, protect the flat panel detector by covering it with a disposable bag. protect the flat panel detector by covering it with a disposable bag. protect the flat panel detector by covering it with a disposable bag. _____________________________________________________________ _____________________________ ________________________________ 2.5 Abnormalities Hazard 2.5 Abnormalities Hazard _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning If any of the following occurs, immediately turn off the power of each unit, If any of the following occurs, immediately turn off the power of each unit, If any of the following occurs, immediately turn off the power of each unit, unplug the power cable from the outlet, and then unplug the power cable from the outlet, and then contact our official dealer or t our official dealer or InnoCare Representative. Representative.

- When smoke, strange odor, or abnormal sound is present. When smoke, strange odor, or abnormal sound is present. When a foreign object (such as a metal object) or liquid enters the

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

- When the equipment is dropped or hit and is damaged. When the equipment is dropped or hit and is damaged. _____________________________________________________________ _______________________________________________ _______________________________________________ 2.6 Installation Precautions 2.6 Installation Precautions _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Cautions Do not install the equipment in a location with the following conditions:

Do not install the equipment in a locatio n with the following conditions:

Where the temperature changes sharply.

- Where the temperature changes sh

- Close to heat sources such as a heater. Close to heat sources such as a heater.

- Where the equipment may be exposed to water due to water leakage or Where the equipment may be exposed to water due to water leakage or Where the equipment may be exposed to water due to water leakage or ingress.

- Where corrosive gas may be generated. Where corrosive gas may be generated.

- Where there is excessive dust. Where there is excessive dust. Where the equipment is subject to frequent or excessive vibrati

- Where the equipment is subject to frequent or excessive vibrati Where the equipment is subject to frequent or excessive vibration/shock. InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 14

- Where the equipment is exposed to direct sunlight. Where the equipment is exposed to direct sunlight. Use the equipment on a flat place. If the equipment falls, it may cause damage Use the equipment on a flat place. If the equipment falls, it may cause damage Use the equipment on a flat place. If the equipment falls, it may cause damage to the equipment or personal injury. to the equipment or personal injury. When you move the equipment, place it in the cassette storage box of a mobile When you move the equipment, place it in the cassette storage box of a mobile When you move the equipment, place it in the cassette storage box of a mobile X-ray unit or hold it by hand to prevent it from falling. If the cart is used to move ray unit or hold it by hand to prevent it from falling. If the cart is used to move ray unit or hold it by hand to prevent it from falling. If the cart is used to move the equipment, place it horizontally. the equipment, place it horizontally. For veterinary or mobile applications, contac For veterinary or mobile applications, contact our official dealer or I Representative. t our official dealer or InnoCare When the devices are used outdoors in wireless communication mode, contac When the devices are used outdoors in wireless communication mode, contact our official dealer or InnoCare nnoCare Representative. Do not place any object in a place where removal of the power cable is Do not place any object in a place where removal of the power cable is Do not place any object in a place where removal of the power cable is prevented. To ensure optimal image quality, it is recommended that you do not use the flat To ensure optimal image quality, it is recommended that you do not use the flat 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 near devices (motor, transformer, switching supply, etc.) that near devices (motor, transformer, switching supply, etc.) that generate electromagnetic noise. generate electromagnetic noise. To ensure optimal image quality, it is recommended that you do not place the To ensure optimal image quality, it is recommended that you do not place the To ensure optimal image quality, it is recommended that you do not place the cables (power cable, back back-up cable, etc.) of the equipment near devices cable, etc.) of the equipment near devices

(motor, transformer, switching supply, etc.) that generate electromagnetic

, transformer, switching supply, etc.) that generate electromagnetic

, transformer, switching supply, etc.) that generate electromagnetic noise and their cables. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.7 Connection Instructions 2.7 Connection Instructions _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning Make sure that the devices to be connected to the equipment are authorized ake sure that the devices to be connected to the equipment are authorized ake sure that the devices to be connected to the equipment are authorized for connection. Connect the panel unit Yushan _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Yushan only to the access point or DR system. access point or DR system. 2.8 External Network Connection External Network Connection External Network Connection _____________________________________________________________ __________________________________________________________ __________________________________________________________ InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 15 Caution When a setting of the network to which the equipment is connected has been When a setting of the network to which the equipment is connected has been When a setting of the network to which the equipment is connected has been changed, check that the change does not affect the system operation and take check that the change does not affect the system operation and take check that the change does not affect the system operation and take measures if necessary. The setting change may include the following:

change may include the following:

- Change of connection destination Change of connection destination Addition of devices

- Removal of devices Removal of devices

- Update of devices

- Upgrade of devices Upgrade of devices After connecting this system to the network with other systems, confirm that After connecting this system to the network with other systems, confirm that After connecting this system to the network with other systems, confirm that the other systems are not affected. the other systems are not affected. If they are affected, take countermeasures If they are affected, take countermeasures such as network separation. such as network separation. Warning Make sure to use the optional parts, accessories and networks recommended Make sure to use the optional parts, accessories and networks recommended Make sure to use the optional parts, accessories and networks recommended by us. Failure by us. Failure by us. Failure the optional parts, accessories and networks the optional parts, accessories and networks the optional parts, accessories and networks recommended by us may result in damage to the equipment and/or electric recommended by us may result in da mage to the equipment and/or electric shock and injury. to use to use to use Connect to the Ethernet Network of 100BASE Connect to the Ethernet Network of 100BASE-TX or 10BASE-T prescribed in T prescribed in the IEEE standard 802.3. Do not connect telephone lines to LAN connector. the IEEE standard 802.3. Do not connect telephone lines to LAN connector. the IEEE standard 802.3. Do not connect telephone lines to LAN connector. Only UTP-type straight LAN cables of 4 type straight LAN cables of 4-pair Category 5 cable (CAT 5E) or cable (CAT 5E) or higher are appropriate for connection to this connector. Compliant with FCC higher are appropriate for connection to this connector. Compliant with FCC part15. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.9 System Isolation Instructions System Isolation Instructions System Isolation Instructions _________________________________________________________ _________________________________________________________ _____________________________________________________________ Warning To ensure complete system To ensure complete system To ensure complete system accessories or other such items. accessories or other such items. isolation, never isolation, never isolation, never install any unauthorized install any unauthorized install any unauthorized InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 16 When it is necessary to install authorized accessories or optional items, When it is necessary to install authorized accessories or optional items, When it is necessary to install authorized accessories or optional items, contact our official dealer or I t our official dealer or InnoCare Representative. Keep equipment other than those used for patients out of their reach to ensure ment other than those used for patients out of their reach to ensure ment other than those used for patients out of their reach to ensure appropriate system isolation. appropriate system isolation. In normal use, have a patient take a proper positioning for exposure. The In normal use, have a patient take a proper positioning for exposure. The 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 operator should operate the system in a place where safety from radiation is operator should operate the system in a place where safety from radiation is ensured. The operator should also make sure before exposure that no one but d. The operator should also make sure before exposure that no one but d. The operator should also make sure before exposure that no one but the patient is in the exposure area and the operating area of the system the patient is in the exposure area and the operating area of the system the patient is in the exposure area and the operating area of the system. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.10 Software Precautions Software Precautions _____________________________________________________________ ________________________ _____________________________________ Caution Do not install additional software to the system. Do not uninstall any of the Do not install additional software to the system. Do not uninstall any of the Do not install additional software to the system. Do not uninstall any of the software preinstalled in the system. The system is preinstalled with the preinstalled in the system. The system is preinstalled with the preinstalled in the system. The system is preinstalled with the appropriate software. If other software is installed or i appropriate software. If other software is installed or if the existing software is f the existing software is uninstalled, various operational errors may result. uninstalled, various operational errors may result.

Open-Source Software Contained in This Product Source Software Contained in This Product

This product contains third partys software that is made available as open This product contains third partys software that is made available as open This product contains third partys software that is made available as open source software or free software. source software or free software. This software is provided as is with no warranty of any kind as to its This software is pro vided as is with no warranty of any kind as to its merchantability or fitness for any particular purpose. merchantability or fitness for any particular purpose. If you would like to receive such sour If you would like to receive such source codes, please contact I ce codes, please contact InnoCare dealer or the service representatives at the agency from which you dealer or the service representatives at the agency from which you dealer or the service representatives at the agency from which you purchased this product. (Please be noted that any inquiries concerning this product. (Please be noted that any inquiries concerning this product. (Please be noted that any inquiries concerning the contents of source codes should be directed to original licensors of the contents of source codes should be directed to original licensors of the contents of source codes should be directed to original licensors of open source software.) open source software.) _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.11 Disinfection Instructions Disinfection Instructions _____________________________________________________________ ________________________________________________________ ________________________________________________________ Warning InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 17 e the following disinfectants at the time of disinfection, which the at the time of disinfection, which the Do not use the following disinfectants quality, performance and safety of the equipment cannot be assured. performance and safety of the equipment cannot be assured. performance and safety of the equipment cannot be assured.

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

- Disinfectant whose uses on metals, plastics, and coating are forbidden Disinfectant whose uses on metals, plastics, and coating are forbidden Disinfectant whose uses on metals, plastics, and coating are forbidden according to the instructions supplied with the disinfectant. instructions supplied with the disinfectant. Formalin gas and disinfectant sprays that may get inside the equipment. Formalin gas and disinfectant sprays that may get inside the equipment. Formalin gas and disinfectant sprays that may get inside the equipment.

- Ultraviolet sterilizers lizers. Disinfectant ethanol is recommended for disinfection. Carefully read the Disinfectant ethanol is recommended for disinfection. Carefully read the Disinfectant ethanol is recommended for disinfection. Carefully read the instructions and cautions supplied with the disinfectant before use. instructions and cautions supplied with the disinfectant before use. instructions and cautions supplied with the disinfectant before use. For details on the disinfectant, contact a I representatives at the agency from which you purchased the disinfectant. representatives at the agency fr om which you purchased the disinfectant. disinfectant, contact a InnoCare dealer or the service dealer or the service Caution If flat panel detector is not disinfected, it may lead secondary infection. is not disinfected, it may lead secondary infection. is not disinfected, it may lead secondary infection. Be sure to disinfect with ethanol after use. Be sure to disinfect with ethanol after use. Clean the flat panel detector to prevent infection. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ detector with ethanol for disinfection, etc. for each patient with ethanol for disinfection, etc. for each patient 2.12 Charging the Battery Pack Charging the Battery Pack _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution nnoCare when battery se the battery charger provided InnoCare Optoelectronics Corp.. For details on operations, refer to the For details on operations, refer to the Charging battery only by the back Charging battery only by the back-up cable provided by InnoCare is installed on Yushan flat panel detector or u is installed on Yushan flat panel detector or use the battery charger by InnoCare Optoelectronics Corp. instruction manual for the battery charger. instruction manual for the battery charger. ine. If the built-in Do not charge the battery pack near fire or under s Do not charge the battery pack near fire or under strong sunshine. If the built mechanisms are activated by a high temperature, the batter mechanisms are activated by a high temperature, the battery pack protection mechanisms are activated by a high temperature, the batter cannot be charged. Also, if the built-in protection mechanisms are damaged, cannot be charged. Also, in protection mechanisms are damaged, extremely high current and voltage, and the battery pack may be charged with reactions may occur inside the battery pack, causing it to abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit smoke, explode or ignite. overheat, emit smoke, explode or ignite. attery pack may be charged with extremely high current and voltage, InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 18 To charge the battery pack, be sure to use the designated To charge the battery pack, be sure to use the designated battery charger and battery charger and the charging conditions specified by InnoCare Optoelectronics to observe the charging conditions specified by e Optoelectronics the battery pack is charged in other conditions (temperature or Corp.. If the battery pack is charged in other conditions (temperature or voltage/current higher than specified, remodeled battery charger, etc.), the voltage/current higher th charger, etc.), the ed with extremely high current, and battery pack may be overcharged or charg battery pack may be overcharged or charged with extremely high current, emical reactions may occur inside the battery pack, causing it to abnormal chemical reactions may occur inside the batter y pack, causing it to overheat, emit smoke, explode or ignite. emit smoke, explode or ignite. Immediately stop charging the battery pack, if charging is not completed within Immediately stop charging the battery pack, if charging is not completed within Immediately stop charging the battery pack, if charging is not completed within time. Otherwise, the battery pack may overheat, emit sm the specified time. Otherwise, the battery pack may overheat, emit sm time. Otherwise, the battery pack may overheat, emit smoke, explode or ignite. Do not use the flat panel Do not use the flat panel detector near the power cable. Do not use a faulty or broken battery charger or AC adapter. Do not use a faulty or broken battery charger or AC adapter. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.13 Battery Pack Instructions Battery Pack Instructions _____________________________________________________________ _____________________ ________________________________________ Warning Battery pack requires regular checkup and replacement. Battery capacity Battery pack requires regular checkup and replacement. Battery capacity Battery pack requires regular checkup and replacement. Battery capacity begins to warm after a period of time. after a period of time. If this equipment is not in use for while, store it with the battery pack removed. If this equipment is not in use for while, store it with the battery pack removed. If this equipment is not in use for while, store it with the battery pack removed. Not removing the battery pack may cause malfunction. g the battery pack may cause malfunction. Caution The battery pack is used with the flat panel detector combinations. used with the flat panel detector. Do not use them in other

. Do not use them in other Charge the battery pack only with the designated battery charger. If the battery Charge the battery pack only with the designated battery charger. If the battery Charge the battery pack only with the designated battery charger. If the battery charged under the charging conditions (voltage, current and charging pack is charged under the cha rging conditions (voltage, current and charging method) different from those specified by InnoCare Optoelectronics Corp., the battery pack may emit smoke, ignite, battery pack may emit smoke, ignite, explode or leak fluid. from those specified by InnoCare Optoelectronics Corp. Store the battery pack in a cool and dark place. Recharge the stored b Store the battery pack in a cool and dark place. Recharge the stored b Store the battery pack in a cool and dark place. Recharge the stored battery pack every six months or every year. Otherwise a decrease in battery capacity six months or every year. Otherwise a decrease in battery capacity six months or every year. Otherwise a decrease in battery capacity or other problems may result. result. InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 19 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 InnoCare. 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 InnoCare 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 InnoCare Optoelectronics Corporaon :-Ray Products 20 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. 21 InnoCare Optoelectronics Corporaon :-Ray Products Wash the eyes immediately with clean water such as tap water, and consult a Wash the eyes immediately with clean water such as tap water, and consult a Wash the eyes immediately with clean water such as tap water, and consult a doctor. Otherwise, eye injury may result. doctor. Otherwise, eye injury may result. Do not use the battery pack Do not use the battery pack in combination with a primary battery such as a dry in combination with a primary battery such as a dry battery or other battery of a different capacity, type and/or brand. Otherwise, battery or other battery of a different capacity, type and/or brand. Otherwise, battery or other battery of a different capacity, type and/or brand. Otherwise, the battery pack may be overcharged during charging, and abnormal chemical the battery pack may be overcharged during charging, and abnormal chemical the battery pack may be overcharged during charging, and abnormal chemical reactions may occur inside the battery pack, caus reactions may occur inside the battery pack, causing it to overheat, emit ing it to overheat, emit smoke, explode or ignite. smoke, explode or ignite. Do not put the battery pack in a microwave oven or high Do not put the battery pack in a microwave oven or high-pressure container. pressure container. Otherwise, the battery pack may be rapidly heated or damaged, causing it to Otherwise, the battery pack may be rapidly heated or damaged, causing it to Otherwise, the battery pack may be rapidly heated or damaged, causing it to overheat, emit smoke, explode or ignite. overheat, emit smoke, explode or ignite. If the battery pack leaks or emits an unusual odor, remove it from fire ry pack leaks or emits an unusual odor, remove it from fire ry pack leaks or emits an unusual odor, remove it from fire immediately. Otherwise, the leaked electrolyte may catch fire, causing the Otherwise, the leaked electrolyte may catch fire, causing the Otherwise, the leaked electrolyte may catch fire, causing the battery pack to overheat, emit smoke, explode or ignite. battery pack to overheat, emit smoke, explode or ignite. If you notice an unusual odor, heat, discoloration, deformation If you notice an unusual odor, heat, discoloration, deformation If you notice an unusual odor, heat, discoloration, deformation or any other abnormality during use, charging or storage, remove the battery pack from the abnormality during use, charging or storage, remove the battery pack from the abnormality during use, charging or storage, remove the battery pack from the equipment or battery charger, and stop using it. Otherwise, the battery pack equipment or battery charger, and stop using it. Otherwise, the battery pack equipment or battery charger, and stop using it. Otherwise, the battery pack may overheat, emit smoke, may overheat, emit smoke, exploder ignite. Do not use the battery pack exposed to a strong magnetic field of an MRI Do not use the battery pack exposed to a stro ng magnetic field of an MRI system, etc. Do not use the battery pack immersed in liquid. o not use the battery pack immersed in liquid. Keep the battery away from fire. Avoid the action of short circuit. Never attempt Keep the battery away from fire. Avoid the action of short circuit. Never attempt Keep the battery away from fire. Avoid the action of short circuit. Never attempt to disassemble the battery pack. to disassemble the battery pack. Use the designated chargers to charge the battery pack. Risk of explosion if Use the designated chargers to charge the battery pa ck. Risk of explosion if battery replaced by an incorrect type. battery replaced by an incorrect type. Dispose of used batteries according to the instructions. Dispose of used batteries according to the instructions. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.14 Warnings for Pediatric Use Warnings for Pediatric Use _____________________________________________________________ _________________________________________ ____________________ Warning If the exposure conditions for average-size adults are applied to children, it If the exposure conditions for average size adults are applied to children, it may cause excessive radiation exposure. excessive radiation exposure. InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 22 Studies show that children are more radiosensitive than adults (i.e. children Studies show that children are more radiosensitive than adults (i.e. children Studies show that children are more radiosensitive than adults (i.e. children are at higher risk of develo same dose of ionizing radiation). Accordingly, in pediatric use, special attention radiation). Accordingly, in pediatric use, special attention radiation). Accordingly, in pediatric use, special attention needs to be paid to avoid needs to be paid to avoid unnecessary exposure. risk of developing cancer compared to adults exposed to the ping cancer compared to adults exposed to the Based on the clinical application, pathological conditions of the patient, pati Based on the clinical application, pathological conditions of the patient, pati Based on the clinical application, pathological conditions of the patient, patient size, and anatomical imaging region, adjust the exposure conditions to use the anatomical imaging region, adjust the exposure conditions to use the anatomical imaging region, adjust the exposure conditions to use the minimum amount of radiation necessary to obtain appropriate medical images. radiation necessary to obtain appropriate medical images. radiation necessary to obtain appropriate medical images. For system operation, if children cannot be exposed at an appropriate dose f children cannot be exposed at an appropriate dose f children cannot be exposed at an appropriate dose with the AEC, do not use the AEC. se the AEC. Adjust the exposure conditions to minimize the X-ray exposure time to avoid Adjust the exposure conditions to minimize the X ray exposure time to avoid repeated exposure due to body movement. exposure due to body movement. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.15 Other Precautions Precautions _____________________________________________________________ ___________________________________________ __________________ Warning No modification of this equipment is allowed. No modification of this equipment is allowed. Because this equipment is not explosion-proof, do not use combustible and Because this equipment is not explosion proof, do not use combustible and explosive gases near the equipment. explosive gases near the equipment. Caution Do not hit or drop the equipment. Otherwise, injury or damage to images, etc. Do not hit or drop the equipment. Otherwise, injury or damage to images, etc. may result. Be sure to inspect the system periodically. Be sure to inspect the system periodically. To assure optimum performance of the equipment, it is necessary to To assure optimum performance of the equipment, it is necessary to To assure optimum performance of the equipment, it is necessary to systematically perform maintenance and inspection. For information on systematically perform maintenance and inspection. For information on systematically perform maintenance and inspection. For information on maintenance and maintenance and InnoCare Representative. inspection, contact our official dealer or inspection, contact our offici al dealer or Do not perform maintenance and inspection while the equipment is used for a Do not perform maintenance and inspection while the equipment is used for a Do not perform maintenance and inspection while the equipment is used for a patient. The institution where the equipment is installed is responsible for its use and The institution where the equipment is installed is responsible for its use and The institution where the equipment is installed is responsible for its use and 23 InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 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 panel detector to X-ray without a subject. Although the flat panel detector conforms to IPX6, no warranty is given as to the prevention of water intrusion in the flat panel detector. If the flat panel detector is splashed with water, wipe off moisture and ensure that the flat panel detector is completely 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 injury. Follow the specified procedure when turning off the equipment. Otherwise, the 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 60950-1 or IEC 62368-1 for IT-equipment and the IEC 60601-series for Medical Electrical Equipment. In addition, all such combinations Medical Electrical Systems shall comply with the safety requirements stated in the general standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept 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. _____________________________________________________________ 2.16 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. 2.17 Product Labels InnoCare Optoelectronics Corporaon :-Ray Products 24 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 Yushan X-Ray Flat Panel Detector. 2.17.1 Identification Label Yushan V14C Yushan V14G InnoCare Optoelectronics Corporaon :-Ray Products 25 Yushan V17C Yushan V17G 2.17.2 Battery Polarity Label InnoCare Optoelectronics Corporaon :-Ray Products 26 2.17.3 Battery Label 2.17.4 Packing Carton Label 2.17.5 Adapter Specification Label InnoCare Optoelectronics Corporaon :-Ray Products 27 2.17.6 Safety Symbols The following safety symbols are used in the labels or on its body. InnoCare Optoelectronics Corporaon :-Ray Products 28 Chapter 3 3.1 How to C o Connect FPD System Configuration onfiguration Yushan FPD can be operated either in wireless connection mode or wired FPD can be operated either in wireless connection mode or wired FPD can be operated either in wireless connection mode or wired connection mode. When using wired mode, back connection mode. When using wired mode, back-up cable is necessary to up cable is necessary to provide the link from FPD to network switch hub or to PC. User can also provide the link from FPD to network switch hub or to PC. User can also connect back-up cable to up cable to the adapter provided by InnoCare to give the power to give the power to operate or charging its battery. If the adapter is not connected, FPD will be to operate or charging its battery. If the ad not connected, FPD will be powered by its own battery. powered by its own battery. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution Do not touch the back-up cable connector otherwise it may result in electric shock or up cable connector of Yushan when in wireless mode when in wireless mode, it may result in electric shock or malfunction of the equipment malfunction of the equipment. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 29 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. 1. Applied part 2. LED indicator 3. Power button 4. Back-up cable connector 5. Battery pack InnoCare Optoelectronics Corporaon :-Ray Products 30 3.2.2 Accessories Back-up cable 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 Input : 100-250V ~ 1.5-0.75A 50-60Hz Description: Medical grade AC/DC adapter which is used to provide power either to detector or use to charge the battery installed on FPD.

- Output : 24V 2.5A

Length : 1.5M The adapter must in accordance with IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012. InnoCare Optoelectronics Corporaon :-Ray Products 31 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 (must in accordance with IEC 62133:2012) InnoCare Optoelectronics Corporaon :-Ray Products 32 Power Cord Description: Connection between AC inlet and adapter input. EU US

PLUG : 6A/250V, CONNECTOR: 10A/250V Length : 3M

PLUG : 10A/125V, CONNECTOR: 10A/125V Length : 2.5M _____________________________________________________________ Note:

Every provided accessory is identified to have not received prior 510(k) clearance. Do not use parts or accessories which are not certified by InnoCare Optoelectronics Corp. or not approved by CE or FDA. _____________________________________________________________ InnoCare Optoelectronics Corporaon :-Ray Products 33 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. InnoCare Optoelectronics Corporaon :-Ray Products 34 4 Basic Operation Chapter 4 Basic O

.1 Preparing the Flat Panel Detector 4.1 Preparing the Flat Panel Detector

.1 Preparing the Flat Panel Detector This section describes how to prepare the f This section describes how to prepare the flat panel detector. 4.1.1 Type of Flat Panel Detector

.1.1 Type of Flat Panel Detector Yushan V14C, Yushan V14G V14G, Yushan V17C, Yushan V17G Detector

.1.2 Number of the Connectable Flat Panel Detector 4.1.2 Number of the Connectable Flat Panel Up to 5 panels can connect to system at the same time. Up to 5 panels can connect to system at the same time. 4.1.3 Connecting/Disconnecting the Flat Pane

.1.3 Connecting/Disconnecting the Flat Pane

.1.3 Connecting/Disconnecting the Flat Panel Detector Do not place the connector on floor. Do not place the connector on floor. Make sure that the latches on both sides are Make sure that the latches on both sides are properly engaged when connecting the properly engaged when connecting the connector. If the connector is inserted If the connector is inserted incompletely, the power incompletely, the power may turn off. InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 35 _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution Do not place the c Do not place the connector on a hard surface such as on a hard surface such as the edge of a bed. the edge of a bed. Make sure that the connector does not protrude from the edge of a bed. Do not raise the flat panel Do not raise the flat panel sensor by holding only the sensor by holding only the connector connector. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 4.1.4 Charging the Battery Pack for the Flat Panel Charging the Battery Pack for the Flat Panel Charging the Battery Pack for the Flat Panel Detector Use the battery charger recommended by Use the battery charger recommended by InnoCare Optoelectronics Corp. details on operations, refer to the instruction manual for the battery charger. details on operations, refer to the instruction manual for the battery charger. details on operations, refer to the instruction manual for the battery charger. oCare Optoelectronics Corp.. For 4.1.5 Installing/Removing the Battery Pack for the Flat Installing/Removing the Battery Pack for the Flat Installing/Removing the Battery Pack for the Flat Panel Detector Follow the procedure below to install/remove the bat Follow the procedure below to install/remove the battery pack for the fl tery pack for the flat panel detector. When installing/removing the battery pack, place the flat panel When installing/removing the battery pack, place the flat panel When installing/removing the battery pack, place the flat panel detector on a flat place. Do not remove the battery pack until a processed image appears in the Do not remove the battery pack until a processed image appears in the Do not remove the battery pack until a processed image appears in the window of the image processing unit after the exposure. window of the image processing unit after the exposure. InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 36 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. InnoCare Optoelectronics Corporaon :-Ray Products 37 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. InnoCare Optoelectronics Corporaon :-Ray Products 38 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.

(Note: SDK is enclosed in the packaging) Users can set client mode parameters through the software interface. Choose wireless in configuration interface. Choose the Client. InnoCare Optoelectronics Corporaon :-Ray Products 39 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. InnoCare Optoelectronics Corporaon :-Ray Products 40 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. InnoCare Optoelectronics Corporaon :-Ray Products 41 InnoCare Optoelectronics Corporaon :-Ray Products 42 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 1. Press the power button for more than 2 second to start the FPD. 2. Make sure that the power LED light in green. 3. Power LED will still light in green. Wait status LED stop flashing. 4. Wait Status LED light in green (ready for exposure) InnoCare Optoelectronics Corporaon :-Ray Products 43 4.3.2 Overview of User Interface

Operation o Enter Operation: Make FPD enter operation state. User can choose exposure mode after FPD is in operation state. o Exit Operation: Make FPD exit operation state. o Set FPD time: Synchronize the time between PC and RTC of FPD.

Mode o Start: Make FPD operate in selected exposure mode. o Stop: Make FPD stop selected exposure mode and return to Idle in operation state. o Reset: Reset the image module (Clear some alert flag). o Mode: Choose exposure mode (AED repeat / AED one shot / Soft Sync /

Acquisition / Discharge). o Auto Download: Download the image to PC after the exposure. o Dont Save to eMMC:

The image is saved in the non-volatile storage of FPD.

The image is only stored in buffer of FPD and will be overwritten by subsequent exposure image. o Corrected Image: Download the corrected image of AED mode. (App ignores this parameter if FPD is not operated in AED mode) o User Key: A number for user key generation. The number increases by 1 after each exposure.

Exposure Configuration (Please refer to AED / Acquisition section for more detail) o Offset:

Taking offset image depends on exposure mode Offset After Exposure (OAX): AED Offset Before Exposure (OBX): Acquisition

Do not take offset image o Clear1: Discharge before take OBX of Acquisition mode. o Delay OBX: If this option is checked, there will be an x-ray window delay between discharge and OBX. Otherwise the OBX is acquired immediately after Clear1. o Clear2: Discharge before take exposure image. o X-Ray Window (ms): X-Ray window in milliseconds. [2.5ms~3s]

o Offset Window (ms): Offset window in milliseconds. [2.5ms~3s]

InnoCare Optoelectronics Corporaon :-Ray Products 44 4.3.3 Search and connect FPD Search and connect FPD Click 1 to discover all reachable FPDs Click 1 to discover all reachable FPDs Expand the selected entry of the list, and select connection by Ethernet or Wifi. Expand the selected entry of the list, and select connection by Ethernet or Wifi. 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 Then click 2 to connect the specified FPD. Note: Please make sure the IP of 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. selected connection is in the same local area network. selected connection is in the same local area network. 4.3.3.1 Wireless connection

.3.1 Wireless connection Expand the selected entry of the list, and select connection by Ethernet. Then Expand the selected entry of the list, and select connection by Ethernet. Then 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 to connect the specified FPD. Note: Please make sure the host PC is to connect the specified FPD. Note: Please make sure the host PC is connected to the specified AP. specified AP. InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 45 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 the currently connected FPD automatically to other FPD disconnect 4.3.4 Enter the operation and select the mode After connecting to FPD, switch to Operation tab InnoCare Optoelectronics Corporaon :-Ray Products 46 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. After selecting the AED one shot mode, press Start. 4.3.5.1 AED one shot mode

- 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) InnoCare Optoelectronics Corporaon :-Ray Products 47

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 doesnt not download the exposure image after each exposure, it only updates the information of the newly created exposure image in the Image List area. 48 InnoCare Optoelectronics Corporaon :-Ray Products 4.3.5.4 Other Operations

- Discharge: Discharge panel.

- Reset operation mode: If errors occur in the exposure workflow, user must Acquisition: Discharge panel and acquire image immediately. use this button to reset. InnoCare Optoelectronics Corporaon :-Ray Products 49

InnoCare Optoelectronics Corporaon :-Ray Products 50 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 51 InnoCare Optoelectronics Corporaon :-Ray Products 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. InnoCare Optoelectronics Corporaon :-Ray Products 52 4.4 Guidelines for Pediatric Applications typically conducts radiologists(Government-certified) usability InnoCare studies that compare Yushan detector models to the marketed devices. Participate radiologists have demonstrated that the images acquired using the Yushan detectors are deemed to be of diagnostic capability. Additionally, please review the following scientific literatures regarding pediatric

(https://www.ncbi.nlm.nih.gov/pubmed/29064378) and neonates

(https://www.ncbi.nlm.nih.gov/pubmed/23086629). The verification of Yushan detectors are using even lower energy or x-ray voltages to acquire the image, which prove the safety and effectiveness for pediatric and neonates applications. Please refer to the following paragraphs for detailed explaination. the physical this study has evaluated image quality For pediatric, characteristics of five detectors (2 for CR and 3 for FPD) for paediatric applications, using the IEC RQA5 energy. The results show a clear evolution in detector performance for both the CR and FPD detectors, with physical image quality continuing to improve. In this artical, the DQE was evaluated at the normal operating detector air kerma (DAK) level, defined at 2.5 Gy for all detectors. The performance of MTF and DQE for Yushan detectors were all tested and verified at the level of 2.0 Gy, and the test results shows highly sensitivity for image quality. For neonates, in this study, they investigated the digital characteristics of the digital mobile X-ray imaging system equipped with a new FPD for different tube voltages, and showed that it has an excellent linearity of the digital characteristics and constant contrast characteristics for tube voltages in the range of 50-110 kV. The system can be used for significantly reducing the ESD to neonatal patients (examined by chest X-ray in the NICU) as well as the X-ray system operator exposure more effectively than is available with conventional systems. The physical characterization of the Yushan detectors were obtained with the standard beam conditions RQA5 (in accordance with IEC 61267:1994) with the x-ray tube voltage 70kV. Furthermore, please review the following link and reduce pediatric technique factors accordingly: http://www.imagegently.org As a general rule, next recommendations shall be observed in pediatrics:

X-Ray Generator must have short exposures times. InnoCare Optoelectronics Corporaon :-Ray Products 53 For system operation, C must be used carefully, preferably use manual technique setting, applying lower doses. If possible, use high kVp techniques.

Positioning the pediatric patient: Pediatric patients are not as likely as adults to understand the need to remain still during the procedure. Therefore it makes sense to provide aids to maintaining stable positioning. It is strongly recommended the use of immobilizing devices such as bean bags and restraint systems (foam wedges, adhesive tapes, etc.) to avoid the need of repeating exposures due to the movement of the pediatric patients. Whenever possible use techniques based on the lowest exposure times. Shielding: We recommend you provide extra shielding of radiosensitive organs or tissues such as eyes, gonads and thyroid glands. Applying a correct collimation will help to protect the patient against excessive radiation as well. Please regarding pediatric radiosensitivity: GROSSMAN, Herman. Radiation Protection in Diagnostic Radiography of Children. Pediatric Radiology, Vol. 51, (No. 1): 141--144, January, 1973: http://pediatrics.aappublications.org/cgi/reprint/51/1/141. following scientific literature review the Technique factors: You should take steps to reduce technique factors to the lowest possible levels consistent with good image acquisition. For example if your adult abdomen settings are: 70--85 kVp, 200--400 mA, 15--80 mAs, consider starting at 65--75 kVp, 100--160 mA, 2.5--10 mAs for a pediatric patient. Whenever possible use high kVp techniques and large SID

(Source Image Distance). Summary:

Use the lowest amount of radiation for adequate imaging based on size Image only when there is a clear medical benefit. Image only the indicated area. of the child (reducing tube output -- kVp and mAs). Try to use always short exposure times, large SID values and immobilizing devices. Avoid multiple scans and use alternative diagnostic studies (such as ultrasound or MRI) when possible. InnoCare Optoelectronics Corporaon :-Ray Products 54 4.5 Correction procedure Correction procedure _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Cautions This procedure should only be done by _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ service engineer. only be done by suitably-trained service engineer. Cautions If the exposure for the corrected images are collected by wrong exposure If the exposure for the corrected images are collected by wrong exposure If the exposure for the corrected images are collected by wrong exposure setting, for example, (A). Over-exposure than or under-exposure (B). Foreign setting, for example, (A). Over exposure (B). Foreign object is put on the surface (C) collimator of Xray tube is not open to the full object is put on the surface (C) collimator of Xray tube is not open to the full object is put on the surface (C) collimator of Xray tube is not open to the full field of FPD. It may lead to image artifact. t may lead to image artifact. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Cautions Do not expose to any X-

_____________________________________________________________ _____________________________________________________________ _____________________________________________________________

-ray during dark image collection. 4.5.1 Collect images

.1 Collect images When the program is executed, the corrected images are collected in When the program is executed, the corrected images are collected in When the program is executed, the corrected images are collected in sequence. First, 16 dark images were collected, then the X sequence. First, 16 dark images were collected, then the X-ray ener ray energy was set to 20 uGy and the X ray window and offset window were both set to 200 ms to 20 uGy and the X ray window and offset window were both set to 200 ms 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 and collected 16 times. The LSB average of the light image is obtained. It 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 needs to fall within the range of 15,000 to 20,000. According to the above 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

(D) and the gain map (G) are calculated. And use the

(D) and the gain map (G) are calculated. And use the following algorithm to correct for raw images. following algorithm to correct for raw images.

- C = corrected image C = corrected image

- R = raw image

- F = flat field image

- D = dark field or dark frame D = dark field or dark frame

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

- G = Gain =

InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 55 4.5.2 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. InnoCare Optoelectronics Corporaon :-Ray Products 56 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. InnoCare Optoelectronics Corporaon :-Ray Products 57 4.5.3 Storage of calibration data

.3 Storage of calibration data 10 sets of calibration data can be stored inside Yushan. Users can update or 10 sets of calibration data can be stored inside Yushan. Users can update or 10 sets of calibration data can be stored inside Yushan. Users can update or get calibration data for the product. get calibration data for the product. After selecting the class of the map, click File to send. Click on After selecting the class of the map, click File to send. Click on After selecting the class of the map, click File to send. Click on the file to be updated to the inside of the product. updated to the inside of the product. Click Set and complete the update. complete the update. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution These actions are carried out by Authorized Personnels not End Users. These actions are carried out by Authorized Personnels not End Users. These actions are carried out by Authorized Personnels not End Users. _____________________________________________________________ ______________________________________________ ______________________________________________ InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 58 4.5.4 Standard Configuration A. Other Essential System Components necessary to perform Digital Radiography

Yushan (Supporting SDK Interface) can be used in combination with the image processing unit provided by System Integrator.

The X-ray equipment is composed of X-ray high voltage generator and X-ray console, etc. The hand switch is connected with the console for the exposure. At first, when making an exposure, press the Prep switch only of the hand switch. After confirming that the X-ray equipment is ready System Integrator of X-rays, press the Exp. switch of the hand switch.

The Access Point is required system, when Yushan is used in wireless communication mode. B. A standard configuration of this device is as below.

Yushan (Supporting SDK Interface):

Flat panel sensor : Yushan V14C / V14G / V17C / V17G The control software is installed and used in a Windows PC (the image processing unit) prepared by the System Integrator. This variation provides images, which diagnostic image process is not implemented, to the image processing unit. An X-ray automatic detection function is used for Yushan V14C / V14G / V17C

/ V17G. This function could detect a start timing of an X-ray exposure using readout signals in the detector. After detecting the start timing of the X-ray exposure, the detector starts collecting of X-ray signals and image readout. InnoCare Optoelectronics Corporaon :-Ray Products 59 C. System overview

Transfer image data generated by Yushan to the memory within Host PC

Generate an image file and information file.

Yushan only provides raw file to system vendors. InnoCare Optoelectronics Corporaon :-Ray Products 60 5 Daily Inspection and Daily Inspection and Chapter 5 Maintenance Maintenance 5.1 Daily User Inspection and

.1 Daily User Inspection and Maintenance Maintenance During maintenance and inspection, strictly observe precautions contained in During maintenance and inspection, strictly observe precautions contained in During maintenance and inspection, strictly observe precautions contained in Chapter 2 Safety and Regulatory Chapter 2 Safety and Regulatory in this manual for you to use the is manual for you to use the device under best conditions. 1.1 Periodical Inspection 5.1.1 Periodical Inspection End User Remove any dirt or dust accumulated in each part of the emove any dirt or dust accumulated in each part of the emove any dirt or dust accumulated in each part of the equipment using a vacuum cleaner or air duster, clean each part equipment using a vacuum cleaner or air duster, clean each part equipment using a vacuum cleaner or air duster, clean each part with a slightly moistened soft cloth an with a slightly moistened soft cloth and then wipe off any moisture d then wipe off any moisture with a dry cloth. Every Three Months See 3.2 Unit Names and the Functions. See 3.2 Unit Names and the Functions. Authorized Personnel Authorized Personnel There are no parts/components that There are no parts/components that needed to be replaced by InnoCare any authorized personnel ersonnel. _____________________________________________________________ ____________________________ _________________________________ needed to be replaced by InnoCare or Caution Be sure to turn off the power before cleaning each part of the device. Be sure to turn off the power before cleaning each part of the device. Be sure to turn off the power before cleaning each part of the device. Ensure sufficient space when cleaning the equipment on a table, etc Ensure sufficient space when cleaning the equipment on a table, etc Ensure sufficient space when cleaning the equipment on a table, etc. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 61 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 local representative InnoCare service engineer or In case of abnormal image, calibrate detector by standard method. Contact InnoCare service engineer or local representative if error is not removed by calibration.

- Other technical issue, contact InnoCare 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. InnoCare Optoelectronics Corporaon :-Ray Products 62 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 Input Voltage Range Nominal Input Frequency Input Frequency Range Output voltage Output current Input connector (AC inlet) Output connector type Min 80 50 Typ. 47 24 Standard IEC 62320-C14 DC JACK 5525 Max 264 60 63 2.5 unit VAC hz hz VDC A InnoCare Optoelectronics Corporaon :-Ray Products 63 A.1.3 Power Supply to Battery Charger A 2-slot battery V14C/V14G/V17C/V17G. charger is provided along with the Yushan 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) Power (Stand-by) Battery voltage Battery capacity Battery operating time in stand-by mode Battery operating time in Operating mode Charging time (by cable) 16 10 11.4 4212 6 4 4 W W V mAh hours hours hours A.1.5 Environmental Conditions A.1.5.1 Storage and Transport Item Temperature Humidity1 Pressure2 Battery storage temperature3 note1: Non-condensing Min

-10C 10%

700mBar

-10C Max 50C 90%

1060mBar 50C note2: 700mBar is equivalant to 3000m in altitude note3: Less than 1 month at 50C

A.1.5.2 Functional Operating the Within V14C/V14G/V17C/V17G are safe and functional. range of functional operating conditions, the Yushan Functional means that the detector is able to deliver an image, whereas the 64 InnoCare Optoelectronics Corporaon :-Ray Products image quality and electro-optical performances are not guaranteed. It also means that, except if mentioned explicitly, any perturbation occurring within those conditions are reversible and not existing anymore when the detector is turned back within the performance operating conditions. Item Temperature Humidity Pressure Weight (uniform load) Weight (local load on 4 cm diameter) Vibrations (10 -200 Hz / 3 axis ) Drop height (the reversibility to full performance is not guaranteed for this item) Min 5C 15%

700mBar A.1.5.3 Performance Operating Typ. 25C 1013mBar Max 35C 80%

1060mBar 300 kg 120 kg 2 g 70 cm Performance is guaranteed in the operating range below. Typ. Item Min. 15C 15%

700mBar

-12C 25C 1013mBar 0C Temperature Humidity Pressure Distance to calibration temperature Weight (uniform load) Weight (local load on 4 cm diameter disc) Vibrations (10 -200 Hz / 3 axis ) Drop (The Yushan V14C/V14G/V17C/V17G remains at full performance after a drop test of following height) Max. 30C 80%

1060mBar

+12C 300 kg 120 kg 2 g 70 cm _____________________________________________________________ InnoCare Optoelectronics Corporaon :-Ray Products 65 Caution When the flat panel detector period of time, it may cause image artifacts and/or failure of the device. period of time, it may cause image artifacts and/or failure of the device. period of time, it may cause image artifacts and/or failure of the device. _______________ _____________________________________________________________ ______________________________________________ detector is used in high temperature condition for long is used in high temperature condition for long A.1.6 Image Performance Image Performance The testing measurement procedure of MTF and DQE is complies with IEC The testing measurement procedure of MTF and DQE is complies with IEC 1 (MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF 62220-1 (MEDICAL ELECTRICAL EQUIPMENT CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES RAY IMAGING DEVICES) as a general X-ray radiography ray radiography equipment. To ensure optimal image quality, it is recom mal image quality, it is recommended that you do not use the flat mended that you do not use the flat panel detector near devices (motor, transformer, switching supply, etc.) that devices (motor, transformer, switching supply, etc.) that devices (motor, transformer, switching supply, etc.) that generate electromagnetic noise. generate electromagnetic noise. V14C/V17C (CsI Version)

(CsI Version) Performance at *RQA5 RQA5 Item Min Typ. Max unit MTF @ 1 lp / mm MTF @ 2 lp / mm MTF @ 3 lp / mm DQE @ 0.5 lp / mm DQE @ 1 lp / mm DQE @ 2 lp / mm DQE @ 3 lp / mm Sensitivity @2uGy Dark noise Maximun linear dose Maximun clipping dose Energy range Max. resolution 0.62 0.31 0.15 0.42 0.40 0.31 0.20 488 75 100 40 0.69 0.39 0.22 0.51 0.48 0.39 0.29 574 4.5 88 120 0.76 0.47 0.28 0.60 0.55 0.47 0.37 660 6 101 140 150 3.57 LSB/uGy LSB uGy uGy KVp lp/mm V14C/V17C (CsI Version)

(CsI Version) Life Time Performance at Performance at

*RQA5 InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 66 Item Min Typ. Max unit MTF @ 1 lp / mm MTF @ 2 lp / mm MTF @ 3 lp / mm DQE @ 0.5 lp / mm DQE @ 1 lp / mm DQE @ 2 lp / mm DQE @ 3 lp / mm 0.55 0.27 0.13 0.38 0.36 0.29 0.19 0.69 0.39 0.22 0.51 0.48 0.39 0.29 V14G/V17G (GOS Version) Performance at *RQA5 Item Min Typ. Max 0.46 0.18 0.08 0.25 0.23 0.13 0.07 503 MTF @ 1 lp / mm MTF @ 2 lp / mm MTF @ 3 lp / mm DQE @ 0.5 lp / mm DQE @ 1 lp / mm DQE @ 2 lp / mm DQE @ 3 lp / mm Sensitivity @2uGy Dark noise Maximun linear dose 75 Maximun clipping dose Energy range Max. resolution 40 100 0.52 0.23 0.11 0.31 0.27 0.16 0.09 592 7.9 88 120 0.57 0.28 0.14 0.37 0.32 0.20 0.12 681 10 101 140 150 3.57 unit LSB/uGy LSB uGy uGy KVp lp/mm V14G/V17G (GOS Version) Life Time Performance at

*RQA5 Item Min Typ. Max unit MTF @ 1 lp / mm MTF @ 2 lp / mm MTF @ 3 lp / mm DQE @ 0.5 lp / mm DQE @ 1 lp / mm DQE @ 2 lp / mm 0.44 0.17 0.07 0.23 0.22 0.12 0.52 0.23 0.11 0.31 0.27 0.16 InnoCare Optoelectronics Corporaon :-Ray Products 67 DQE @ 3 lp / mm 0.06 0.09

*The above specifications have been verified by INX; The physical characterization of the systems was obtained with the standard beam conditions RQA5 (in accordance with IEC 61267:1994). A.1.7 Radio Waves Wireless specifications for the flat panel detector and the access point are as follows. Item Wireless specification Transmit frequency Antenna Date rate Authentication AP mode Specification IEEE802.11 ac / a/g/n 5.2, 5.3, 5.6, 2.4 GHz 2 866Mbps (802.11ac) WPA/WPA2-PSK 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 X-ray hardness Expect service life 100 10 unit Gy years InnoCare Optoelectronics Corporaon :-Ray Products 68 A.2 External View and Weight Item Yushan V14C Yushan V14G Yushan V17C Yushan V17G Width 460 460 460 460 Yushan V14 series Length (mm) Height (mm) Weight (Kg) 383 383 460 460 15 15 15 15 2.7 2.7 3.1 3.2 Yushan V17 series InnoCare Optoelectronics Corporaon :-Ray Products 69 Appendix B Electromagnetic Appendix B Electromagnetic Appendix B Electromagnetic Compatibility (EMC) Compatibility (EMC) B.1 Yushan FPD B.1 Yushan FPD This equipment has been tested and found to comply with the limits for medical This equipment has been tested and found to comply with the limits for medical This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601 devices to the IEC 60601-1-2:2014/EN 60601-1-2:2015. These limits are designed to provide reasonable protection against harmful These limits are designed to provide re asonable protection against harmful interference in a typical medical installation. interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if This equipment generates, uses and can radiate radio frequency energy and, if This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful not installed and used in accordance with the instructions, may cause harmful not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular However, there is no guarantee that interference will not occur in a particular However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can If this equipment does cause harmful interference to other devices, which can If this equipment does cause harmful interference to other devices, which can be determined by tuning the equipment off and on, the be determined by tuning the equipment off and on, the user is encouraged to user is encouraged to try to correct the interference by one or more of the following measures:

try to correct the interference by one or more of the following measures:

- Reorient or relocate the receiving device. Reorient or relocate the receiving device.

Increase the separation between the equipment. Increase the separation between the equipment. Connect the equipment into an outlet on a circuit different from that

- Connect the equipment into an outlet on a circuit different from that Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. which the other device(s) are connected. If the problem cannot be solved with the above measures, stop using this If the problem cannot be solved with the above measures, stop using this If the problem cannot be solved with the above measures, stop using this

, our official dealer or InnoCare equipment and consult the manufacturer equipment and consult the manufacturer, our official dealer or I Representative for help. Representative for help. _____________________________________________________________ _________________________________________ ____________________ Warning Do not place devices generating electromagnetic wave near this equipment. Do not place devices generating electromagnetic wave near this equipment. Do not place devices generating electromagnetic wave near this equipment. If a device(s) other than those specified is connected, predetermined EMC If a device(s) other than those specified is connected, predetermined EMC If a device(s) other than those specified is connected, predetermined EMC performance can not be guaranteed. performance can not be guaranteed. ___________________ _____________________________________________________________ __________________________________________ 70 InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products B.2 Further Information for IEC B.2 Further Information for IEC 60601-1-2 (EN 60601 _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2 (EN 60601-1-2) Caution This equipment is not intended for use in residential environments and may not This equipment is not intended for use in residential environments and may not This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments. provide adequate protection to radio reception in such environments. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 1. Medical electrical equipment needs special precautions regarding EMC and 1. Medical electrical equipment needs special precautions regarding EMC and 1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information needs to be installed and put into service according to the EMC information needs to be installed and put into service according to the EMC information provided in the accompanying documents. rovided in the accompanying documents. 2. Portable and mobile RF communications equipment can affect medical 2. Portable and mobile RF communications equipment can affect medical 2. Portable and mobile RF communications equipment can affect medical electrical equipment. 3. Information regarding the cable affecting EMC is as follows. 3. Information regarding the cable affecting EMC is as follows. Name Connection Connection General specification General specification Network cable Extend Back Extend Back-up cable to PC or cable to PC or network switch. network switch. From adaptor to AC Use a hospital grade power cord Use a hospital grade power cord outlet Cat 5e or more Cat 5e or more UTP type and straight UTP type and straight cable Power cord From adaptor to AC Maximum length 20m 4. The use of accessories, transducers and cables other than those specified, 4. The use of accessories, transducers and cables other than those specified, 4. The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by e exception of transducers and cables sold by InnoCare Optoelectronics InnoCare Optoelectronics Corp. as replacement parts for internal components, may result in increased as replacement parts for internal components, may result in increased as replacement parts for internal components, may result in increased emissions or decreased immunity of the Yushan. emissions or decreased immunity of the Yushan. d not be used adjacent to or stacked with o 5. The Yushan should not be used adjacent to or stacked with o d not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Yushan FPD should be observed If adjacent or stacked use is necessary, the Yushan FPD should be observed If adjacent or stacked use is necessary, the Yushan FPD should be observed to verify normal operation in the configuration in which it will be used. to verify normal operation in the configuration in which it will be used. to verify normal operation in the configuration in which it will be used. 6. Basic performance of the equipment and the system 6. Basic performance of the equipment and the system InnoCare Optoelectronics Care Optoelectronics Corporaon :-Ray Products Ray Products 71 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 Manufacturers declaration-electromagnetic emissions The Yushan V14C, Yushan V14G is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Yushan V14C, Yushan V14G should assure that it is used in such an environment. Emission test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class A Harmonic emissions IEC 61000-3-2 Voltage fluctuations

/flicker emissions IEC 61000-3-3 Not applicable Compliance Electromagnetic environment-guidance

(for professional healthcare environment) The Yushan V14C, Yushan V14G uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Yushan V14C, Yushan V14G is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Manufacturers declaration-electromagnetic immunity The Yushan V14C, Yushan V14G is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Yushan V14C, Yushan V14G should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance InnoCare Optoelectronics Corporaon :-Ray Products

(for professional 72 Electrostatic discharge(ESD) IEC 61000-4-2 Contact:8 kV Air2 kV,4 kV,8 kV,15 kV Contact:8 kV Air2 kV,4 kV,8 kV,15 kV Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

+ 2kV for power supply lines

+ 1kV for input/output lines

+ 0.5kV, +1kV line(s) to line(s)

+ 0.5kV, +1kV,+ 2kV line(s) to earth Voltage dips:

0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles Voltage interruptions:

0 % UT; 250/300 cycle

+ 2kV for power supply lines

+ 1kV for input/output lines

+ 0.5kV, +1kV line(s) to line(s)

+ 0.5kV, +1kV,+ 2kV line(s) to earth Voltage dips:

0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25 cycles Voltage interruptions:

0 % UT; 250 cycle 30 A/m 50 Hz or 60 Hz 30 A/m 50 Hz Power frequency(50, 60 Hz) magnetic field IEC 61000-4-8 healthcare environment) Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Mains power quality should be that of a typical professional healthcare environment. Mains power quality should be that of a typical professional healthcare environment. Mains power quality should be that of a typical professional healthcare environment. If the user of the Yushan V14C, Yushan V14G requires continued operation during power mains interruptions, it is recommended that the Yushan V14C, Yushan V14G be powered from an uninterruptible power supply or a battery. The Yushan V14C, Yushan V14G power frequency magnetic fields should be at levels characteristic of a typical location in a typical professional healthcare InnoCare Optoelectronics Corporaon :-Ray Products 73 environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Manufacturers declaration-electromagnetic immunity The Yushan V14C, Yushan V14G is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Yushan V14C, Yushan V14G should assure that it is used in such and environment. Immunity test Electromagnetic IEC 60601 test Compliance level level environment-guidance (for Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms:

0,15 MHz 80 MHz 6 Vrms:

in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz 3 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz 3 Vrms:

0,15 MHz 80 MHz 6 Vrms:

in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz e) 3 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz professional healthcare environment) Portable and mobile RF communications equipment should be used no closer to any part of the Yushan V14C, Yushan V14G including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

d = 1,2 P d = 1,2 P 80MHz to 800 MHz d = 2,3 P 800MHz to 2,7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Interference may occur in the vicinity of equipment marked with the following symbol:

74 InnoCare Optoelectronics Corporaon :-Ray Products NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Recommended separation distance between portable and mobile RF communications equipment and the Yushan V14C, Yushan V14G The Yushan V14C, Yushan V14G is intended for use in an electromagnetic environment (for professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the Yushan V14C, Yushan V14G can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the Yushan V14C, Yushan V14G as recommended below, according to the maximum output power of the communications equipment. Rated maximum output Separation distance according to frequency of transmitter power of transmitter m W 150 kHz to 80 80 MHz to 800 800 MHz to 2,7 GHz 0,01 0,1 1 10 100 MHz d =1,2P MHz d =1,2P d =2,3P 0,12 0,38 1,2 3,8 12 0,12 0,38 1,2 3,8 12 0,23 0,73 2,3 7,3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. InnoCare Optoelectronics Corporaon :-Ray Products 75 Manufacturers declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The Yushan V14C, Yushan V14G is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Yushan V14C, Yushan V14G should assure that it is used in such an environment. Test frequency

(MHz) Band a)

(MHz) Service a) Modulation b) Maximum power

(W) Distance

(m) IMMUNITY TEST LEVEL

(V/m) Compliance LEVEL

(V/m)

(for professional healthcare) 385 380 390 TETRA 400 430 470 GMRS 460, FRS 460 704 787 LTE Band 13, 17 Pulse modulation b)18 Hz FM c)5 kHz deviation 1 kHz sine Pulse modulation b) 217 Hz 1,8 0,3 2 0,3 27 28 0,2 0,3 9 800 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation b) 18 Hz 2 0,3 28 450 710 745 780 810 870 930 27 28 9 28 InnoCare Optoelectronics Corporaon :-Ray Products 76 1 720 1 845 1 700 1 990 GSM 1800; CDMA 1900; GSM 1900;

Pulse modulation b) DECT; LTE Band 1, 3, 217 Hz 1 970 4, 25; UMTS 2 450 2 400 2 570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 2 0,3 28 2 0,3 28 5 240 5 500 5 100 5 800 WLAN 802.11 a/n 5 785 Pulse modulation b) 217 Hz 0,2 0,3 9 28 28 9 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. InnoCare Optoelectronics Corporaon :-Ray Products 77 Appendix C Radio Frequency (RF) Compliance Information 1. For U.S.A. and Canada Federal Communications Commission (FCC) Statement You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the users 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.

- Connect the equipment into an outlet on a circuit different from that to Increase the separation between the equipment and receiver. 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 InnoCare Optoelectronics Corporaon :-Ray Products 78 uncontrolled environment. This equipment should be installed and operated with a minimum distance of 0 cm between the radiator and your body. 2. For European Union and EEA-EFTA Requirements in AT/BE/BG/CZ/DK/EE/FR/DE/IS/IE/IT/EL/ES/CY/LV/LI/LT/LU/

HU/MT/NL/NO/PL/PT/RO/SI/SK/TR/FI/SE/CH/UK/HR. 5150MHz~5350MHz is for indoor use only. SAR is measured with the device at 0 mm to the body, while transmitting at the highest certified output power level in all frequency bands of the device. The maximum SAR value is 1.7 W/kg (head/body) averaged over 10 gram of tissue. This equipment should be installed and operated with a minimum distance of 0 cm between the radiator and your body Note:

Member State abbreviation as below:

Belgium (BE), Bulgaria (BG), Czech Republic (CZ), Denmark (DK), Germany

(DE), Estonia (EE), Ireland (IE), Greece (EL), Spain (ES), France (FR), Croatia

(HR), Italy (IT), Cyprus (CY), Latvia (LV), Lithuania (LT), Luxembourg (LU), Hungary (HU), Malta (MT), Netherlands (NL), Austria (AT), Poland (PL), Portugal (PT), Romania (RO), Slovenia (SI), Slovakia (SK), Finland (FI), Sweden (SE) and United Kingdom (UK). EEA-EFTA abbreviation as below:

Iceland (IS), Norway (NO), Liechtenstein (LI), Switzerland (CH). InnoCare Optoelectronics Corporaon :-Ray Products 79 InnoCare Optoelectronics Corporaon :-Ray Products 80 InnoCare Optoelectronics Corporaon :-Ray Products 81

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This product uses the FCC Data API but is not endorsed or certified by the FCC