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1 2 3 4 5 6 | External Photos | February 01 2019 / February 07 2019 | ||||||
1 2 3 4 5 6 | Cover Letter(s) | February 01 2019 / March 01 2019 | ||||||
1 2 3 4 5 6 | Cover Letter(s) | February 01 2019 / March 01 2019 | ||||||
1 2 3 4 5 6 | Test Report | February 01 2019 / March 01 2019 |
1 2 3 4 5 6 | User manual | Users Manual | 2.32 MiB |
Yushan Series X-Ray Flat Panel Detector Operation Manual INNOLUX Corporation 17: +HFH= :-R=y PHducts 1 Radiologist or any other practitioners licensed Radiologist or any other practitioners licensed should ensure that they have should ensure that they have Yushan X-Ray adequate knowledge of the operation prior using the adequate knowledge of the operation prior using the INNOLUX Y 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 INNOLUX Yushan X the INNOLUX Yushan X-Ray Flat Panel Detector and cautions to be observed and cautions to be observed when operating it. After reading this manual, store it nearby the After reading this manual, store it nearby the INNOLUX Yushan X Panel Detector so that you can see it whenever necessary so that you can see it whenever necessary. INNOLUX Yushan X-Ray Flat
"Caution: Federal Law restricts this device to sale by or ral Law restricts this device to sale by or on the order of a 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 which radiologist or any other practitioners licensed by the law of the state in which that person practices to use or order the use of the device. 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, please check local regulations. If any local legislation Before using the device, please check local regulations. If any local legislation is violated, use cannot be authorized. 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 INNOLUX Representative. our official dealer or INNOLUX Representative. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Trademarks Company names described in this manual are the trademarks or registered described in this manual are the trademarks or registered described in this manual are the trademarks or registered trademarks of INNOLUX Corporation or their respective holders. trademarks of INNOLUX Corporation or their respective holders. trademarks of INNOLUX Corporation or their respective holders. Windows is the registered trademark of US Microsoft Corporation in the U.S.A. Windows is the registered trademark of US Microsoft Corporation in the U.S.A. Windows is the registered trademark of US Microsoft Corporation in the U.S.A. and other countries. Copyright 2013 INNOLUX Corporatio INNOLUX Corporation. All rights reserved. Document Number: YS-
-OM-01 Version: A1 Issued date: 2018/09/18 8 17: +HFH= :
17: +HFH= :-R=y PHducts 2 Table of Content Chapter 1 Introduction ............................................................................................. 6 Product Introduction ............................................................................ 7 1.1 Product Series ....................................................................................... 7 1.2 Product Intended 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 Other Precautions .................................................................................. 22 2.15 Disposal of Waste .................................................................................. 24 2.16 Product Labels ........................................................................................ 24 2.16.1 Identification Label ..................................................................... 25 2.16.2 Battery Polarity Label ................................................................ 25 2.16.3 Battery Label ................................................................................ 26 2.16.4 Packing Carton Label ................................................................ 26 2.16.5 Adapter Specification Label ..................................................... 26 17: +HFH= :-R=y PHducts 3 2.16.6 Safety Symbols ........................................................................... 27 3.1 How to Connect FPD ............................................................................... 28 3.2 Unit Names and the Functions ............................................................. 29 3.2.1 Flat Panel Detector ....................................................................... 29 3.2.2 Accessories .................................................................................... 30 3.3 LED indicators ........................................................................................... 33 Chapter 4 Basic Operation ................................................................................... 34 4.1 Preparing the Flat Panel Detector ........................................................ 34 4.1.1 Type of Flat Panel Detector ........................................................ 34 4.1.2 Number of the Connectable Flat Panel Detector .................. 34 4.1.3 Connecting/Disconnecting the Flat Panel Detector ............ 34 4.1.4 Charging the Battery Pack for the Flat Panel Detector ....... 35 4.1.5 Installing/Removing the Battery Pack for the Flat Panel Detector ..................................................................................................... 35 4.1.6 LED Indicator to show battery capacity .................................. 36 4.2 Detector Connection................................................................................ 37 4.2.1 Wire connection ............................................................................ 37 4.2.2 Wireless connection ..................................................................... 38 4.2.3 AP mode connection .................................................................... 39 4.3 Starting Up and Shutting Down the Yushan FPD ............................ 41 4.3.1 Starting Up the Yushan ............................................................... 41 4.3.2 Overview of User Interface ......................................................... 41 4.3.3 Search and connect FPD ............................................................ 42 4.3.4 Enter the operation and select the mode ............................... 44 4.3.5 Performing an Exposure and Image Acquistion .................. 45 4.3.6 Download image from FPD ......................................................... 48 4.3.7 Shutting Down the Yushan ......................................................... 49 4.4 Correction procedure .............................................................................. 50 4.4.1 Collect images ............................................................................... 50 4.4.2 Correction process ....................................................................... 51 4.4.3 Storage of calibration data ......................................................... 53 5.1 Daily User Inspection and Maintenance ............................................. 54 5.1.1 Periodical Inspection ................................................................... 54 Chapter 6 Troubleshooting .................................................................................. 55 Appendix A Specifications of FPD ..................................................................... 56 A.1 Specifications ........................................................................................... 56 A.1.1 Reduced Equivalent ..................................................................... 56 A.1.2 Power Supply Conditions when Using Back-up Cable ...... 56 17: +HFH= :-R=y PHducts 4 A.1.3 Power Supply to Battery Charger ............................................ 57 A.1.4 Power Consumption and Battery Specification ................... 57 A.1.5 Environmental Conditions ......................................................... 57 A.1.6 Image Performance ...................................................................... 59 A.1.7 Radio Waves .................................................................................. 60 A.1.8 Reliability and Lifetime ............................................................... 60 Appendix B Electromagnetic Compatibility (EMC) ........................................ 62 B.1 Yushan FPD ............................................................................................... 62 B.2 Further Information for IEC 60601-1-2 (EN 60601-1-2) ................... 63 Appendix C Radio Frequency (RF) Compliance Information ...................... 64 17: +HFH= :-R=y PHducts 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 INNOLUX Yushan X-Ray Flat Panel Ray Flat Panel Detector. This manual is not intended to provide instructions on actual Detector. This manual is not intended to provide instructions on actual Detector. This manual is not intended to provide instructions on actual treatment procedures and it is expected that users should have official treatment procedures and it is expected that users should have official treatment procedures and it is expected that users should have official license prior to using the device. The radiologist or any other practitioners radiologist or any other practitioners license prior to using the stribution organization assume no liability thro Manufacturer and Distribution organization assume no liability thro stribution organization assume no liability through 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 manua l 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 using non-approved or responsible for damages or injury caused as a result of or responsible for damages or injury caused as a result of using no accessories. Installation may only be conducted by authorized service Installation may only be conducted by authorized service Installation may only be conducted by authorized service personal. Some maintenance and service work Some maintenance and service work also must be carried out by 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 all and service manual are allowed. Any service work carried out by unauthorized owed. 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 conta provided in this manual then please contact the manufacturer or your local ct the manufacturer or your local distributor in writing with your reasons for wanting them and then a copy of the distributor in writing with your reasons for wanting them and then a copy of the distributor in writing with your reasons for wanting them and then a copy of the service manual may be provided. Before using the service manual may be provided. Before using the INNOLUX Yushan X Yushan X-Ray the operator should read this manual carefully and Flat Panel Detector, the operator should read this manual carefully and the operator should read this manual carefully and pay particular attention to the sections of Safety, Operation and Maintenance. particular attention to the sections of Safety, Operation and Maintenance. particular attention to the sections of Safety, Operation and Maintenance. ________________________________________ ____________________________________________________________ _____________________ Caution INNOLUX Corporation shall not be liable for malfunctions and damages INNOLUX Corporation shall not be liable for malfunctions and damages INNOLUX Corporation shall not be liable for malfunctions and damages resulting from use under resulting from use under environment conditions outside the range of using environment conditions outside the range of using conditions for this product such as power supply, installation environment, etc. conditions for this product such as power supply, installation environment, etc. conditions for this product such as power supply, installation environment, etc. contained in this manual. contained in this manual. INNOLUX Corporation shall not be liable for malfunctions and damages INNOLUX Corporation shall not be liable for malfunctions and damages INNOLUX Corporation shall not be liable for malfunctions and damages resulting from natural disaste resulting from natural disasters such as fires, earthquakes, floods, lightning, rs such as fires, earthquakes, floods, lightning, etc. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 17: +HFH= :
17: +HFH= :-R=y PHducts 6 1.1 Product Introduction INNOLUX Yushan X-Ray Flat Panel Detector is an X-ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and an X-ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic. Each X ray photon will be converted to electronic signal by scintillator and the sensor array. Electronic signal in the pixel will be readout by driver IC and then become an image before send to PC. 1.2 Product Series Model Yushan V14C Yushan V14G Description Glass version 14x 17 FPD with CsI Glass version 14x 17 FPD with GOS 1.3 Product Intended Use The Wireless/Wired INNOLUX Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. INNOLUX Yushan series provide either raw X ray image or corrected image for system integrator to do further image process. 1.4 Product Significant Performance Characteristics Items Characteristics Image resolution Data MTF (Modulation transfer function) (Typical) 2500x3052 16 bit data 0.69 @ 1 lp/mm 0.39 @ 2 lp/mm 0.22 @ 3 lp/mm 0.52 @ 1 lp/mm 0.23 @ 2 lp/mm CsI GOS 17: +HFH= :-R=y PHducts 7 0.11 @ 3 lp/mm 0.51 @ 0 lp/mm 0.48 @ 1 lp/mm 0.39 @ 2 lp/mm 0.29 @ 3 lp/mm 0.31 @ 0 lp/mm 0.27 @ 1 lp/mm 0.16 @ 2 lp/mm 0.09 @ 3 lp/mm 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 DQE (Detector quantum efficiency) (Typical) Maximum linear dose (Typical) Sensitivity (Typical) Dark noise (Typical) Lag 1.5 Product Intended Patient Population Considerations Age Height Weight Health Nationality Sex Requirement Description
- Not restricted
- Not restricted
-
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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 17: +HFH= :-R=y PHducts 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
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- 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
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Less than ten minute contact Indoor use only Ambient luminance range: 100 to 1500 lx Viewing angle: normal to the display 20
- Reusable
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-
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1day: 200 shot In hospital environment Portable ME equipment to be used on a patient 17: +HFH= :-R=y PHducts 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 INNOLUX before using. A complete training should consist of the following elements:
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All safety precautions for practitioners and patients when using the device. A review of published clinical literature should be conducted to understand the indications and effects of the X-Ray Flat Panel Detector. _____________________________________________________________ Note It is strongly recommended for INNOLUX Yushan practitioners to attend organized meetings, workshops, seminars, and conferences on use of X-Ray Flat Panel Detector. _____________________________________________________________ 17: +HFH= :-R=y PHducts 10 Chapter 2 Safety and Regulatory This INNOLUX Yushan X-Ray Flat Panel Detector has been designed and tested to function in a safe and correct when used as indicated in this manual. Do not use this device before reading and completely understand this Operation Manual. Always observe precautions for safety and only operates the device in a qualified room that provides protection. 2.1 Compliance Standards and Classification 2.1.1 Compliance Standards
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FDA Standards 21 CFR 1020.31 for ionizing radiation emitting products FDA Standards 21 CFR 892.1680 for stationary x-ray system European Medical Devices Directive (93/42/EEC) EN ISO 13485:2016 EN ISO 14971:2012 EN 60601-1: 2006+A1: 2013+A12: 2014 ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 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
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- RED Directive (2014/53/EU)
- RoHS Directive (2011/65/EU)
- REACH Directive (EC/1907/2006)
- WEEE Directive (2012/19/EU) 17: +HFH= :-R=y PHducts 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 Equipment
- 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 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 flammable anesthetics Degree of safety of application in the presence of a flammable anesthetics mixture with air or with oxygen or nitrous oxide: Equipment not suitable for 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 e in the presence of a flammable anesthetics mixture with air or with e 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 2.3 Power Supply Hazard _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning The power supply to the Yushan is AC 100 to 240V. 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:
To avoid electric shocks, users should always take the following precautions:
- Do not open any covers when it is not necessary. 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. 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.
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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 17: +HFH= :
17: +HFH= :-R=y PHducts 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 17: +HFH= :-R=y PHducts packs are not attached, an electric shock may result. packs are not attached, an electric shock may result. Make sure to use the optional parts and accessories the optional parts and accessories provided by innolux. provided by innolux. 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 injury. result in damage to the equipment and/or electric shock and injury. Keep the equipment away from patients body fluids, chemical Keep the equipment away from patients body fluids, chemical 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 contact our official dealer or unplug the power cable from the outlet, and then contact our official dealer or unplug the power cable from the outlet, and then contact our official dealer or INNOLUX Representative. INNOLUX Representative.
When smoke, strange odor, or abnormal sound is present. hen smoke, strange odor, or abnormal sound is present.
When a foreign object (such as a metal object) or liquid enters the product. When a foreign object (such as a metal object) or liquid enters the product. 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 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 sharply.
- 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 the equipment may be exposed to water due to water leakage or 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 vibration/shock. Where the equipment is subject to frequent or excessive vibration/shock. Where the equipment is subject to frequent or excessive vibration/shock. Where the equipment is exposed to direct sunlight.
- Where the equipment is exposed to direct 17: +HFH= :
17: +HFH= :-R=y PHducts 14 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 ray unit or hold it by hand to prevent it from falling. If the cart is used to move X-ray unit or hold it by hand to prevent it from fal ling. If the cart is used to move the equipment, place it horizontally. the equipment, place it horizontally. For veterinary or mobile applications, contact our official dealer or INNOLUX For veterinary or mobile applications, contact our official dealer or INNOLUX For veterinary or mobile applications, contact our official dealer or INNOLUX Representative. When the devices are used outdoors in wireless communication mode, contact When the devices are used outdoors in wireless communication mode, contact When the devices are used outdoors in wireless communication mode, contact our official dealer or INNOLUX Representative. aler or INNOLUX 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 nsformer, switching supply, etc.) that generate electromagnetic nsformer, 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 sure that the devices to be connected to the equipment are authorized 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 _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 17: +HFH= :
17: +HFH= :-R=y PHducts 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:
setting change may include the following:
- Change of connection destination Change of connection destination Addition of devices
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- 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 af the other systems are not affected. If they are affected, take countermeasures fected. 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 resu lt in damage 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 tegory 5 cable (CAT 5E) or higher are appropriate for connection to this connector. higher are appropriate for connection to this connector. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 2.9 System Isolation Instructions System Isolation Instructions System Isolation Instructions _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning To ensure complete system ensure complete system 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 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, 17: +HFH= :
17: +HFH= :-R=y PHducts 16 contact our official dealer or INNOLUX Representative. contact our official dealer or INNOLUX Representative. Keep equipment other than those used for patients out of their reach to ensure Keep equipment other than tho se 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 sho ensured. The operator should also make sure before exposure that no one but uld 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 if the existing software is appropriate software. If other so ftware is installed or if the existing software is uninstalled, various operational errors may result. uninstalled, various operational errors may result.
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Open-Source Software Contained in This Product Source Software Contained in This Product
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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 softwa source software or free software. This software is provided as is with no warranty of any kind as to its This software is provided as is with no warranty of any kind as to its This software is provided 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 source codes, please contact INNOLUX If you would like to receive such source codes, please contact INNOLUX If you would like to receive such source codes, please contact INNOLUX dealer or the service representatives at the agency dealer or the service representatives at the agency from which you from which you purchased this product. (Please be noted that any inquiries concerning purchased this product. (Please be noted that any inquiries concerning purchased 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 ction Instructions _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning Do not use the following disinfectants or sterilizers at the time of disinfection, Do not use the following disinfectants or sterilize rs at the time of disinfection, 17 17: +HFH= :
17: +HFH= :-R=y PHducts which the quality, performance and safety of the equipment cannot be performance and safety of the equipment cannot be performance and safety of the equipment cannot be assured.
- Chloric disinfectant which is strongly corrosive to metals and rubber parts. Chloric disinfectant which is strongly corrosive to metals and rubber parts. Chloric disinfectant which is strongly corrosive 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.
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Formalin gas and disinfectant sprays that may get inside the equipment.
- Ultraviolet sterilizers Ultraviolet sterilizers. 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 INNOLUX dealer or th For details on the disinfectant, contact a INNOLUX dealer or th For details on the disinfectant, contact a INNOLUX dealer or the service representatives at the agency from which you purchased the disinfectant. representatives at the agency from which you purchased the disinfectant. representatives at the agency from which you purchased the disinfectant. 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 battery only by the back-up cable provided by INNOLUX when Charging battery only by the back up cable provided by INNOLUX when battery is installed on Yushan flat panel detector or use the battery charger battery is installed on Yushan flat panel detector or u se the battery charger provided by INNOLUX Corporation. by INNOLUX Corporation. For details on operations, refer to the For details on operations, refer to the instruction manual for the battery charger. instruction manual for the battery charger. not charge the battery pack near fire or under strong sunshine. If the built ine. If the built-in Do not charge the battery pack near fire or under strong sunsh 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, attery pack may be charged with extremely high current and voltage, and the battery pack may be extremely high current and voltage, and abnormal chemical reactions may occur inside the reactions may occur inside the battery pack, causing it to battery pack, causing it to overheat, emit smoke, explode or ignite. overheat, emit smoke, explode or ignite. 17: +HFH= :
17: +HFH= :-R=y PHducts 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 INNOLUX Corporation. If the charging conditions specified by INNOLUX Corporation. If the to observe the charging conditions specified by INNOLUX Corporation. If battery pack is charged in other conditions (temperature or voltage/current battery pack is charged in other conditions (temperature or voltage/current higher than specified, remodeled battery an specified, remodeled battery charger, etc.), the battery pack may charger, etc.), the battery pack may ercharged or charged with extremely high current, and abnormal be overcharged or charg and abnormal chemical reactions may occur inside the batter chemical reactions may occur inside the battery pack, causing it to overheat, 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 the specified time. Otherwise, the battery pack may overheat, emit smoke, time. Otherwise, the battery pack may overheat, emit smoke, 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. removing 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 pack is charged under the charging conditions (voltage, current and charging charged under the charging conditions (voltage, current and charging charged under the charging conditions (voltage, current and charging method) different from those specified by INNOLUX Corporation, the battery from those specified by INNOLUX Corporation, the battery from those specified by INNOLUX Corporation, the battery pack may emit smoke, ignite, smoke, ignite, explode or leak fluid. Store the battery pack in a cool and dark place. Recharge the stored battery Store the battery pack in a cool and dark place. Recharge the stored battery 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. 17: +HFH= :
17: +HFH= :-R=y PHducts 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 INNOLUX. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid. When disposing of the battery pack, consult our official dealer or INNOLUX Representative. Do not disassemble or remodel the battery pack. The battery pack is equipped with built-in safety and protection mechanisms. If they are damaged, the battery pack may overheat, emit smoke, explode or ignite. Be careful not to drop the battery pack. The patient may be injured. Do not touch the terminal of the battery pack directly. There is a risk of electric shock. Do not connect the positive (+) and negative (-) terminals with a wire or any metal object. Do not carry or store the battery pack together with metal objects such as necklaces or hairpins. Otherwise, the battery pack may short-circuit and overcurrent may flow, causing the battery pack to overheat, emit smoke, explode or ignite. Metal objects such as necklaces or hairpins may also become hot. Do not throw the battery pack into fire or expose it to excessive heat. Otherwise, its insulator may melt, its gas release vent or safety mechanisms may be damaged, and/or its electrolyte may catch fire, causing the battery pack to overheat, emit smoke, explode or ignite. Do not use or leave the battery pack in a place where it is exposed to high temperature (60C or higher), such as fire or a heater. If the resin separator is damaged due to heat, the battery pack may short-circuit, causing it to overheat, emit smoke, explode or ignite. Do not immerse the battery pack in water or seawater, and do not allow it to become wet. If the built-in protection mechanisms are damaged, the battery 17: +HFH= :-R=y PHducts 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 17: +HFH= :-R=y PHducts 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 in combination with a primary battery such as a dry Do not use the battery pack in combination with a primary battery such as a dry Do not use the battery pack in combination with a primary battery such as a dry battery or other battery of a different capacity, type and/or brand. Otherwise, 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 ry pack may be overcharged during charging, and abnormal chemical ry pack may be overcharged during charging, and abnormal chemical reactions may occur inside the battery pack, causing it to overheat, emit reactions may occur inside the battery pack, causing it to overheat, emit reactions may occur inside the battery pack, causing 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 battery pack may be rapidly heated or damaged, causing it to 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 If the battery pack leaks or emits an unusual odor, remove it from fire If the battery 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. y pack to overheat, emit smoke, explode or ignite. If you notice an unusual odor, heat, discoloration, deformation or any other If you notice an unusual odor, heat, discoloration, deformation or any other 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. O therwise, 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 strong magnetic field of an MRI Do not use the battery pack exposed to a strong 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 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 pack. Risk of explosion if Use the designated chargers to charge the battery pack. 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 Other Precautions Precautions _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Warning No modification of this equipment is allowed. No modification of this equipment is allowed. 17: +HFH= :
17: +HFH= :-R=y PHducts 22 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. 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 maintenance and INNOLUX INNOLUX INNOLUX Representative. inspection, contact our official dealer or inspection, contact our official dealer or inspection, contact our official 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 ere the equipment is installed is responsible for its use and ere the equipment is installed is responsible for its use and maintenance. In addition, this equipment should not be used by persons other maintenance. In addition, this equipment should not be used by persons other maintenance. In addition, this equipment should not be used by persons other than doctors or suitably trained staff. than doctors or suitably trained staff. Be careful not to expose the flat panel detector to X-ray without a subject. Be careful not to expose the flat p ray without a subject. Although the flat panel detector conforms to IPX6, no warranty is given as to Although the flat panel conforms to IPX6, no warranty is given as to the prevention of water intrusion in the flat panel the prevention of water intrusion in the flat panel detector. If the flat panel
. If the flat panel detector is splashed with water, wipe off moisture and ensure that the flat is splashed with water, wipe off moisture and ensure that the flat is splashed with water, wipe off moisture and ensure that the flat panel detector is completely dry before use. letely dry before use. As the cables of the equipment are long, be careful not to entangle the cables As the cables of the equipment are long, be careful not to entangle the cables 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 during use. Also, be careful not to trip over the cables. Falls could result in 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. Ot Follow the specified procedure when turning off the equipment. Ot Follow the specified procedure when turning off the equipment. Otherwise, the flat panel detector could be damaged by thermal shock. flat panel detector could be damaged by thermal shock. External equipment intended for connection to signal inputs, signal outputs or External equipment intended for connection to signal inputs, signal outputs or External equipment intended for connection to signal inputs, signal outputs or other connectors shall comply with the relevant product standard e.g. IEC other connectors shall comply with the relevant product standard e.g. IEC other connectors shall comply with the relevant product standard e.g. IEC 60950-1 or IEC 62368 ment and the IEC 60601-series for 1 or IEC 62368-1 for IT-equipment and the IEC 60601 Medical Electrical Equipment. In addition, all such combinations Medical Electrical Equipment. In addition, all such combinations Medical Medical Electrical Equipment. In addition, all such combinations Electrical Systems shall comply with the safety requirements stated in the shall comply with the safety requirements stated in the shall comply with the safety requirements stated in the general standard IEC 60601-1, edition 3, clause 16. Any equipment not general standard IEC 60601 1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601 complying with the leakage current requirements in IEC 60601-1 shall be kept 1 shall be kept 23 17: +HFH= :
17: +HFH= :-R=y PHducts outside the patient environment i.e. at least 1.5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents. Any person who connects external equipment to signal inputs, signal outputs or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative. _____________________________________________________________ 2.15 Disposal of Waste It is illegal to place the device in the trash. Please contact the qualified local recycling provides before disposing the device, The disposal procedure should comply with local law. 2.16 Product Labels The information of each label can be found in this section and the corresponding location are also presented as the following figure. The following labels are adhered to the INNOLUX Yushan X-Ray Flat Panel Detector. 17: +HFH= :-R=y PHducts 24 2.16.1 Identification Label Yushan V14C Yushan V14G 2.16.2 Battery Polarity Label 17: +HFH= :-R=y PHducts 25 2.16.3 Battery Label 2.16.4 Packing Carton Label 2.16.5 Adapter Specification Label 17: +HFH= :-R=y PHducts 26 2.16.6 Safety Symbols The following safety symbols are used in the labels or on its body. 27 17: +HFH= :-R=y PHducts Chapter 3 3.1 How to C System Configuration onfiguration o Connect FPD Yushan FPD can be operated either in wireless connection mode or wired Yushan FPD can be operated either in wireless connection mode or wired Yushan 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 up cable to the adapter provided by INNOLUX to give the power connect back-up cable to the adapter provid ed by INNOLUX to give the power to operate or charging its battery. If the ad to operate or charging its battery. If the adapter is not connected, FPD will be not connected, FPD will be powered by its own battery. powered by its own battery. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution Do not touch the back-up cable 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. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 17: +HFH= :
17: +HFH= :-R=y PHducts 28 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. 17: +HFH= :-R=y PHducts 29 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 Description: Medical grade AC/DC adapter which is used to provide power either to detector or use to charge the battery installed on FPD.
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- Output : 24V 2.5A
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Input : 100-250V ~ 1.5-0.75A 50-60Hz Length : 1.5M 17: +HFH= :-R=y PHducts 30 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 17: +HFH= :-R=y PHducts 31 Power Cord Description: Connection between AC inlet and adapter input. EU US
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PLUG : 6A/250V, CONNECTOR: 10A/250V Length : 3M
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PLUG : 10A/125V, CONNECTOR: 10A/125V Length : 2.5M _____________________________________________________________ Note:
Every accessory cant be sale or used as an independent product, which is not compatible with other devices. Therefore, every provided accessory is identified to have not received prior 510(k) clearance. Do not use parts or accessories which are not certified by INNOLUX Corporation or not approved by CE or FDA. _____________________________________________________________ 17: +HFH= :-R=y PHducts 32 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. 17: +HFH= :-R=y PHducts 33 Chapter 4 Basic Operation 4.1 Preparing the Flat Panel Detector This section describes how to prepare the flat panel detector. 4.1.1 Type of Flat Panel Detector Yushan V14C, Yushan V14G 4.1.2 Number of the Connectable Flat Panel Detector Up to 5 panels can connect to system at the same time. 4.1.3 Connecting/Disconnecting the Flat Panel Detector 17: +HFH= :-R=y PHducts 34 _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution Do not place the connector 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 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 INNOLUX Corporation. Use the battery charger recommended by INNOLUX Corporation. Use the battery charger recommended by INNOLUX Corporation. For details on operations, refer to the instruction manual for the battery charger. to the instruction manual for the battery charger. to the instruction manual for the battery charger. 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 flat panel 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. 17: +HFH= :
17: +HFH= :-R=y PHducts 35 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. 17: +HFH= :-R=y PHducts 36 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. 17: +HFH= :-R=y PHducts 37 4.2.2 Wireless connection SDK command is used to setup SSID and password of wireless access point. This setup to FPD need to be done first before wireless connection. Users can set client mode parameters through the software interface. Choose wireless in configuration interface. Choose the Client. Set the SSID and pass phrase of AP to be connected to the product. 17: +HFH= :-R=y PHducts 38 4.2.3 AP mode connection Users can set AP mode parameters through the software interface. Choose wireless in configuration interface. Choose the AP. 17: +HFH= :-R=y PHducts 39 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. 17: +HFH= :-R=y PHducts 40 4.3 Starting Up and Shutting Down the Yushan FPD This section explains how to start up and shut down the Yushan. 4.3.1 Starting Up the Yushan Press the power button for more than 2 second to start the FPD. 1. Make sure that the power LED light in green. 2. Wait Status LED stop flashing 3. Wait Link LED light in green 4. Wait Status LED light in green (ready for exposure) 4.3.2 Overview of User Interface
- Discover: The area is used to list all FPD those are discovered and reachable.
- Operations: The tool bar contains different exposure mode. 17: +HFH= :-R=y PHducts 41 Message: The area is used to display important message to users.
- Message: The area is used to display important message to users.
- Diagnosis: The area lists several diagnostic messages of FPD that is Diagnosis: The area lists several diagnostic messages of FPD that is Diagnosis: The area lists several diagnostic messages of FPD that is currently connected. currently connected. Image List: The area lists the images created by exposure operations. Image List: The area lists the images created by exposure operations. Image List: The area lists the images created by exposure operations.
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4.3.3 Search and connect FPD Search and connect FPD Click 1 to discover all reachable FPDs 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. Host PC and the selected connection is in the same local area network. Host PC and the selected connection is in the same local area network. 17: +HFH= :
17: +HFH= :-R=y PHducts 42 4.3.3.1 Wireless connection Expand the selected entry of the list, and select connection by Ethernet. Then click 2 to connect the specified FPD. Note: Please make sure the host PC is connected to the specified AP. After establishing the connection, you can check the diagnosis field on the right to confirm the information of Yushan products. The message appears to indicate a successful connection. After connection is established, you can use 3 to disconnect the FPD. Note:
Connecting the currently connected FPD automatically to other FPD disconnect 17: +HFH= :-R=y PHducts 43 4.3.4 Enter the operation and select the mode
.4 Enter the operation and select the mode
.4 Enter the operation and select the mode Enter operation mode / Exit operation mode:
Enter operation mode / Exit operation mode:
The FPD must enter operation mode before take or dark image. The FPD must enter operation mode before take exposure or dark After FPD enters operations mode, user can perform several exposure mode. After FPD enters operations mode, user can perform several exposure mode. After FPD enters operations mode, user can perform several exposure mode. 17: +HFH= :
17: +HFH= :-R=y PHducts 44 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.
-
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17: +HFH= :-R=y PHducts 45 4.3.5.2 Software sync mode (Emulation of two-stage exposure button)
-
This group only serves as emulation of two-stage exposure button, and verifies the API functionality. After selecting the Software sync mode, press Start.
-
- When performing an exposure, make sure that the STATUS LED light in green and not flashing. 4.3.5.3 AED repeat mode After selecting the AED repeat mode, press Start.
-
- When FPD is in AED repeat mode, it stays in AED repeat mode after
-
each X-Ray exposure is detected. User can use Stop to exit AED repeat mode. The utility 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. 17: +HFH= :-R=y PHducts 46 The steps of downloading exposure images are The steps of downloading exposure images are AED repeat mode a. Exit the AED repeat b. Use the Get Image List to update the Image List (Optional) Use the Get Image List to update the Image List (Optional) Use the Get Image List to update the Image List (Optional) Select the image and click Download Raw button c. Select the image and click Download Raw button 17: +HFH= :
17: +HFH= :-R=y PHducts 47 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. 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 17: +HFH= :-R=y PHducts 48 The image data is first stored in the DDR SDRAM and then transferred to the PC. When the status of image has been show ready, it means the images is already stored in the DDR SDRAM.
-
Image download OK When the status of image has been show OK, it means the images is already stored in the PC.
- Archive after continuous image taking If the automatic download function is not checked, the image will be stored in the DDR SDRAM. First, press (3) to list all the information of the image, and then press the arrow of (1) to output the original image to the PC. In addition, if there is an image with offset set at the beginning of the exposure, press the (2) arrow to output the offset image to the PC. 4.3.7 Shutting Down the Yushan Press the power button for more than 2 second to shut down the FPD. 17: +HFH= :-R=y PHducts 49 4.4 Correction procedure 4.4.1 Collect images When the program is executed, the corrected images are collected in sequence. First, 16 dark images were collected, then the X-ray energy was set to 20 uGy and the X ray window and offset window were both set to 200 ms and collected 16 times. The LSB average of the light image is obtained. It needs to fall within the range of 15,000 to 20,000. According to the above image, the offset map (D) and the gain map (G) are calculated. And use the following algorithm to correct for raw images.
- C = corrected image
- R = raw image
- F = flat field image
- D = dark field or dark frame
- m = image-averaged value of (F-D)
- G = Gain =
17: +HFH= :-R=y PHducts 50 4.4.2 Correction process First get 16 dark images and 16 light images, sort and store the images in the same folder, and create another folder named "calib".And store the image to be corrected in the same folder and fill in the name of the folder. Click Noise : The mode represents the level of noise. The () represents the number of pixels. 17: +HFH= :-R=y PHducts 51 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. 17: +HFH= :-R=y PHducts 52 4.4.3 Storage of calibration data 4.4.3 Storage of calibration data 10 sets of calibration data can be stored inside Yushan. Users can update or calibration data can be stored inside Yushan. Users can update or 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 the file to be After selecting the class of the map, click File to send. Click on the file to be 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 =d complete 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. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 17: +HFH= :
17: +HFH= :-R=y PHducts 53 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 in this manual for you to use the device Chapter 2 Safety and Regulatory Chapter 2 Safety and Regulatory in this manual for you to use the 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 and then wipe off any moisture with a slightly moistened soft cloth and then wipe off any moisture with a slightly moistened soft cloth and 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 needed to be replaced by Innolux or any There are no parts/components that needed to be replaced by Innolux or any There are no parts/components that needed to be replaced by Innolux or any authorized personnel. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 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. 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. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 17: +HFH= :
17: +HFH= :-R=y PHducts 54 Chapter 6 Troubleshooting
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In case of smoke, fire, abnormal high temperature, remove battery and power supply and turn off detector imediately. In case of yellow error LED on, it may trigger the impact. Please read the manual to release the status and restart the power; if the yellow light cannot be removed, contact INNOLUX service engineer or local representative In case of abnormal image, calibrate detector by standard method. Contact INNOLUX service engineer or local representative if error is not removed by calibration.
- Other technical issue, contact INNOLUX service engineer or local representative.
- When Yushan cannot be turned on, please check if the battery has power or if the DC power supply is connected.
- When the software shows that the network can't connect, please confirm the signal of Yushan first. If it is wireless network, the third light needs to be solid green to indicate that it has been connected. If the green light flashes, it means that Yushan is not connected. At this time, please check the network settings of the environment and the computer, and have successfully connected. 17: +HFH= :-R=y PHducts 55 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 17: +HFH= :-R=y PHducts 56 A.1.3 Power Supply to Battery Charger A 2-slot battery charger is provided along with the Yushan V14C/V14G. The battery charger is delivered with its AC/DC adapter which is the same as A.1.2. A.1.4 Power Consumption and Battery Specification Item Specification (typical) Unit Power (Operating) 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 Within the range of functional operating conditions, the Yushan V14C, Yushan V14G are safe and functional. Functional means that the detector is able to deliver an image, whereas the image quality and electro-optical performances are not guaranteed. It also 57 17: +HFH= :-R=y PHducts means that, except if mentioned explicitly, any perturbation occurring within means that, except if mentioned explicitly, any perturbation occurring within means that, except if mentioned explicitly, any perturbation occurring within those conditions are reversible and not existing anymore when the detector is conditions are reversible and not existing anymore when the detector is conditions are reversible and not existing anymore when the detector is turned back within the performance operating conditions. turned back within the performance operating conditions. Item Temperature Humidity Pressure Weight (uniform load) Weight (local load on 4 cm Weight (local load on 4 cm diameter) Vibrations (10 -200 Hz / 3 200 Hz / 3 axis ) Drop height (the reversibility Drop height (the reversibility to full performance is not not guaranteed for this item) guaranteed for this item) Min 5C 15%
700mBar A.1.5.3 Performance
.3 Performance Operating Typ. 25C 1013mBar Max 35C 35 80%
80%
1060mBar 1060mBar 300 kg 300 kg 120 kg 120 kg 2 g 2 g 70 cm 70 cm Performance is guaranteed in the Performance is guaranteed in the operating range below. Typ. Item Min. Temperature Humidity Pressure Distance to calibration Distance to calibration temperature Weight (uniform load) Weight (local load on 4 cm Weight (local load on 4 cm diameter disc) Vibrations (10 -200 Hz / 3 200 Hz / 3 axis ) Drop (The Yushan-V14C V14C/G remains at full performance performance after a drop test of following after a drop test of following height) 15C 15%
700mBar
-12C 25C 1013mBar 0C Max. 30C 30 80%
80%
1060mBar 1060mBar
+12C
+12 300 kg 300 kg 120 kg 120 kg 2 g 2 g 70 cm 70 cm _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ Caution 17: +HFH= :
17: +HFH= :-R=y PHducts 58 When the flat panel detector is used in high temperature condition for long period of time, it may cause image artifacts and/or failure of the device. _____________________________________________________________ A.1.6 Image Performance Each flat panel detector complies with IEC 62220-1 (MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES) as a general X-ray radiography equipment. To ensure optimal image quality, it is recommended that you do not use the flat panel detector near devices (motor, transformer, switching supply, etc.) that generate electromagnetic noise. V14C (CsI Version) Performance at RQA5 Item Min Typ. Max unit 0.62 0.35 0.18 0.45 0.43 0.35 0.23 488 MTF @ 1 lp / mm MTF @ 2 lp / mm MTF @ 3 lp / mm DQE @ 0 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 100 0.69 0.39 0.22 0.51 0.48 0.39 0.29 574 4.5 88 120 0.76 0.43 0.26 0.56 0.53 0.44 0.35 660 6 101 140 LSB/uGy LSB uGy uGy V14G (GOS Version) Performance at RQA5 Item Min Typ. Max unit MTF @ 1 lp / mm MTF @ 2 lp / mm MTF @ 3 lp / mm DQE @ 0 lp / mm DQE @ 1 lp / mm DQE @ 2 lp / mm 0.47 0.20 0.06 0.27 0.23 0.11 0.52 0.23 0.11 0.31 0.27 0.16 0.57 0.26 0.16 0.35 0.31 0.21 17: +HFH= :-R=y PHducts 59 0.04 503 DQE @ 3 lp / mm Sensitivity @2uGy Dark noise Maximun linear dose 75 Maximun clipping dose 100 0.09 592 7.9 88 120 0.14 681 10 101 140 LSB/uGy LSB uGy uGy 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.
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A.1.8 Reliability and Lifetime Item Specification X-ray hardness Expect service life 100 10 unit Gy years 17: +HFH= :-R=y PHducts 60 A.2 External View and Weight Item Yushan V14C Yushan V14G Width 460 460 Length (mm) Height (mm) Weight (Kg) 383 383 15 15 2.7 2.7 17: +HFH= :-R=y PHducts 61 Appendix B Electromagnetic Appendix B Electromagnetic Appendix B Electromagnetic Compatibility 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 reasonable protection against harmful These limits are designed to provide reasonable protection against harmful interference in a typical 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. interference to 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 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 user is encouraged to be determined by tuning the equipment off and on, the user is encouraged to be determined by tuning the equipment off and on, the 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 to
- Connect the equipment into an outlet on a circuit different from that to 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 nnot be solved with the above measures, stop using this nnot be solved with the above measures, stop using this equipment and consult the manufacturer, our official dealer or INNOLUX equipment and consult the manufacturer, our official dealer or INNOLUX equipment and consult the manufacturer, our official dealer or INNOLUX 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. 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. _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ 17: +HFH= :
17: +HFH= :-R=y PHducts 62 Maximum length 20m B.2 Further Information for IEC 60601-1-2 (EN 60601-1-2) 1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. 2. Portable and mobile RF communications equipment can affect medical electrical equipment. 3. Information regarding the cable affecting EMC is as follows. Name Connection General specification Network cable Extend Back-up cable to PC or network switch. Cat 5e or more UTP type and straight cable Power cord From adaptor to AC Use a hospital grade power cord outlet 4. The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by INNOLUX Corporation as replacement parts for internal components, may result in increased emissions or decreased immunity of the Yushan. 5. The Yushan should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Yushan FPD should be observed to verify normal operation in the configuration in which it will be used. 6. Basic performance of the equipment and the system After image data are acquired from the flat panel detector, offset data correction is performed by flat pane detector and then the image is send to DR system via wireless connection or wired connection. 7. Test items (Tables 1 to 4) Waiting for EMC report. 17: +HFH= :-R=y PHducts 63 Appendix C Radio Frequency (RF) Compliance Information Federal Communications Commission (FCC) Statement You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the 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 uncontrolled environment. This equipment should be installed and operated 17: +HFH= :-R=y PHducts 64 with a minimum distance of 0 cm between the radiator and your body. 65 17: +HFH= :-R=y PHducts
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-02-21 | 2412 ~ 2472 | DTS - Digital Transmission System | Class II permissive change or modification of presently authorized equipment |
2 | 5290 ~ 5290 | NII - Unlicensed National Information Infrastructure TX | ||
3 | 2019-01-03 | 2412 ~ 2472 | DTS - Digital Transmission System | Change in identification of presently authorized equipment. Original FCC ID: PD98265NG Grant Date: 06/03/2016 |
4 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter | ||
5 | 5775 ~ 5775 | NII - Unlicensed National Information Infrastructure TX | ||
6 | JBP - Part 15 Class B Computing Device Peripheral |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 4 5 6 | Effective |
2019-02-21
|
||||
1 2 3 4 5 6 |
2019-01-03
|
|||||
1 2 3 4 5 6 | Applicant's complete, legal business name |
Innolux Corporation
|
||||
1 2 3 4 5 6 | FCC Registration Number (FRN) |
0027721067
|
||||
1 2 3 4 5 6 | Physical Address |
No. 160, Kesyue Rd. Jhunan Science Park
|
||||
1 2 3 4 5 6 |
Miaoli County, N/A 350
|
|||||
1 2 3 4 5 6 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 2 3 4 5 6 | TCB Application Email Address |
c******@telefication.com
|
||||
1 2 3 4 5 6 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
1 2 3 4 5 6 |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
|||||
app s | FCC ID | |||||
1 2 3 4 5 6 | Grantee Code |
2AQPW
|
||||
1 2 3 4 5 6 | Equipment Product Code |
000001
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 4 5 6 | Name |
J****** C****
|
||||
1 2 3 4 5 6 | Title |
Engineer
|
||||
1 2 3 4 5 6 | Telephone Number |
886-6********
|
||||
1 2 3 4 5 6 | Fax Number |
886-6********
|
||||
1 2 3 4 5 6 |
j******@innolux.com
|
|||||
app s | Technical Contact | |||||
1 2 3 4 5 6 | Firm Name |
SGS Taiwan Ltd
|
||||
1 2 3 4 5 6 |
SGS Taiwan Ltd.
|
|||||
1 2 3 4 5 6 | Name |
J******** C********
|
||||
1 2 3 4 5 6 | Physical Address |
134, Wu Kung Road, WuKu Industrial Zone
|
||||
1 2 3 4 5 6 |
Taiwan
|
|||||
1 2 3 4 5 6 | Telephone Number |
886 2********
|
||||
1 2 3 4 5 6 |
88622******** Extension:
|
|||||
1 2 3 4 5 6 | Fax Number |
886 2********
|
||||
1 2 3 4 5 6 |
88622********
|
|||||
1 2 3 4 5 6 |
j******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 2 3 4 5 6 | Firm Name |
SGS Taiwan Ltd
|
||||
1 2 3 4 5 6 |
SGS Taiwan Ltd.
|
|||||
1 2 3 4 5 6 | Name |
J******** C******
|
||||
1 2 3 4 5 6 | Physical Address |
134, Wu Kung Road, WuKu Industrial Zone
|
||||
1 2 3 4 5 6 |
Taiwan
|
|||||
1 2 3 4 5 6 | Telephone Number |
886 2********
|
||||
1 2 3 4 5 6 |
88622******** Extension:
|
|||||
1 2 3 4 5 6 | Fax Number |
886 2********
|
||||
1 2 3 4 5 6 |
88622********
|
|||||
1 2 3 4 5 6 |
j******@sgs.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 3 4 5 6 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
1 2 3 4 5 6 | Yes | |||||
1 2 3 4 5 6 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 4 5 6 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 08/19/2019 | ||||
1 2 3 4 5 6 | 07/02/2019 | |||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 3 4 5 6 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 4 5 6 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 3 4 5 6 | NII - Unlicensed National Information Infrastructure TX | |||||
1 2 3 4 5 6 | DSS - Part 15 Spread Spectrum Transmitter | |||||
1 2 3 4 5 6 | JBP - Part 15 Class B Computing Device Peripheral | |||||
1 2 3 4 5 6 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Flat Panel Detector | ||||
1 2 3 4 5 6 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 4 5 6 | Modular Equipment Type | Single Modular Approval | ||||
1 2 3 4 5 6 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 3 4 5 6 | Change in identification of presently authorized equipment. Original FCC ID: PD98265NG Grant Date: 06/03/2016 | |||||
1 2 3 4 5 6 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 3 4 5 6 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 3 4 5 6 | Grant Comments | C2PC: Integrating the module into a new portable host ( Model : Yushan V14C, Yushan V14G, Yushan F14C & Yushan F14G). The highest reported SAR values for Head, Body and Simultaneous SAR are 1.36 W/kg, 1.43 W/kg and 1.43 W/kg respectively. Change in identification of presently authorized equipment : Original FCC ID: PD98265NG, Grant Date: 06/03/2016. Power Output listed is conducted. Modular Approval. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Grantee must provide installation and operating instructions for complying with FCC multi-transmitter product procedures. This module is approved in mobile/portable configurations. Only those antenna(s) tested with the device or similar antenna(s) with equal or lesser gain may be used with this transmitter. Grantee must coordinate with OEM integrator to determine applicable host configurations to ensure RF exposure compliance, including simultaneous transmission SAR requirements according to published KDB 616217 Supplement documentation. When all conditions of this filing cannot be met installation of this device into specific final products may require the submission of a permissive change application, containing appropriate data demonstrating compliance, or a new application. OEM/Host integrator must be provided with antenna installation instructions and transmitter operating conditions to satisfy RF exposure compliance. Device is a client only device enabled for 2.4 GHz band operations and also has 20MHz, 40MHz and 80MHz bandwidth modes as described in this filing. OEM/Host integrator is responsible for complying with the instructions and requirements for each transmitter they choose to integrate into a host product. The highest reported SAR values are Body and Simultaneous SAR are 0.46W/kg and 0.91W/kg respectively. | ||||
1 2 3 4 5 6 | C2PC: Integrating the module into a new portable host ( Model : Yushan V14C, Yushan V14G, Yushan F14C & Yushan F14G). The highest reported SAR values for Head, Body and Simultaneous SAR are 1.35 W/kg, 1.21 W/kg and 1.43 W/kg respectively. Change in identification of presently authorized equipment : Original FCC ID: PD98265NG, Grant Date: 06/03/2016. Power Output listed is conducted. Modular Approval. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Grantee must provide installation and operating instructions for complying with FCC multi-transmitter product procedures. This module is approved in mobile/portable configurations. Only those antenna(s) tested with the device or similar antenna(s) with equal or lesser gain may be used with this transmitter. Grantee must coordinate with OEM integrator to determine applicable host configurations to ensure RF exposure compliance, including simultaneous transmission SAR requirements according to published KDB 616217 supplement documentation. When all conditions of this filing cannot be met installation of this device into specific final products may require the submission of a permissive change application, containing appropriate data demonstrating compliance, or a new application. Device is a client only device enabled for 5GHz band operations and also has 20MHz, 40MHz and 80MHz bandwidth modes as described in this filing. OEM/Host integrator must be provided with antenna installation instructions and transmitter operating conditions to satisfy RF exposure compliance. OEM/Host integrator is responsible for complying with the instructions and requirements for each transmitter they choose to integrate into a host product. The highest reported Body and Simultaneous SAR values are 0.75W/kg and 1.44W/kg respectively. | |||||
1 2 3 4 5 6 | Change in identification of presently authorized equipment : Original FCC ID: PD98265NG, Grant Date: 06/03/2016. Power Output listed is conducted. Modular Approval. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Grantee must provide installation and operating instructions for complying with FCC multi-transmitter product procedures. This module is approved in mobile/portable configurations. Only those antenna(s) tested with the device or similar antenna(s) with equal or lesser gain may be used with this transmitter. Grantee must coordinate with OEM integrator to determine applicable host configurations to ensure RF exposure compliance, including simultaneous transmission SAR requirements according to published KDB 616217 Supplement documentation. When all conditions of this filing cannot be met installation of this device into specific final products may require the submission of a permissive change application, containing appropriate data demonstrating compliance, or a new application. OEM/Host integrator must be provided with antenna installation instructions and transmitter operating conditions to satisfy RF exposure compliance. Device is a client only device enabled for 2.4 GHz band operations and also has 20MHz, 40MHz and 80MHz bandwidth modes as described in this filing. OEM/Host integrator is responsible for complying with the instructions and requirements for each transmitter they choose to integrate into a host product. The highest reported SAR values are Body and Simultaneous SAR are 0.46W/kg and 0.91W/kg respectively. | |||||
1 2 3 4 5 6 | Change in identification of presently authorized equipment : Original FCC ID: PD98265NG, Grant Date: 06/03/2016. Power Output listed is conducted. Modular Approval filing. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Grantee must provide installation and operating instructions for complying with FCC multi-transmitter product procedures. Only those antenna(s) tested with the device or similar antenna(s) with equal or lesser gain may be used with this transmitter. End-users and installers must be provided with transmitter operating conditions for satisfying RF exposure compliance. The highest reported Body and Simultaneous SAR values are 0.05W/kg and 0.78W/kg respectively. | |||||
1 2 3 4 5 6 | Change in identification of presently authorized equipment : Original FCC ID: PD98265NG, Grant Date: 06/03/2016. Power Output listed is conducted. Modular Approval. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Grantee must provide installation and operating instructions for complying with FCC multi-transmitter product procedures. This module is approved in mobile/portable configurations. Only those antenna(s) tested with the device or similar antenna(s) with equal or lesser gain may be used with this transmitter. Grantee must coordinate with OEM integrator to determine applicable host configurations to ensure RF exposure compliance, including simultaneous transmission SAR requirements according to published KDB 616217 supplement documentation. When all conditions of this filing cannot be met installation of this device into specific final products may require the submission of a permissive change application, containing appropriate data demonstrating compliance, or a new application. Device is a client only device enabled for 5GHz band operations and also has 20MHz, 40MHz and 80MHz bandwidth modes as described in this filing. OEM/Host integrator must be provided with antenna installation instructions and transmitter operating conditions to satisfy RF exposure compliance. OEM/Host integrator is responsible for complying with the instructions and requirements for each transmitter they choose to integrate into a host product. The highest reported Body and Simultaneous SAR values are 0.75W/kg and 1.44W/kg respectively. | |||||
1 2 3 4 5 6 | Change in identification of presently authorized equipment : Original FCC ID: PD98265NG, Grant Date: 06/03/2016. | |||||
1 2 3 4 5 6 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 4 5 6 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 3 4 5 6 | Firm Name |
SGS Taiwan Ltd. Electronics & Communication Lab
|
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1 2 3 4 5 6 | Name |
R******** W******
|
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1 2 3 4 5 6 | Telephone Number |
+886-******** Extension:
|
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1 2 3 4 5 6 | Fax Number |
+886-********
|
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1 2 3 4 5 6 |
r******@sgs.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC MO | 2412 | 2472 | 1 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15C | CC MO | 2422 | 2462 | 0.494 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15E | 38 CC MO | 5180 | 5240 | 0.161 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15E | 38 CC MO | 5190 | 5230 | 0.153 | |||||||||||||||||||||||||||||||||||
2 | 3 | 15E | 38 CC MO | 5210 | 5210 | 0.021 | |||||||||||||||||||||||||||||||||||
2 | 4 | 15E | 38 CC MO ND | 5260 | 5320 | 0.159 | |||||||||||||||||||||||||||||||||||
2 | 5 | 15E | 38 CC MO ND | 5270 | 5310 | 0.166 | |||||||||||||||||||||||||||||||||||
2 | 6 | 15E | 38 CC MO ND | 5290 | 5290 | 0.027 | |||||||||||||||||||||||||||||||||||
2 | 7 | 15E | 38 CC MO ND | 5500 | 5700 | 0.108 | |||||||||||||||||||||||||||||||||||
2 | 8 | 15E | 38 CC MO ND | 5510 | 5670 | 0.119 | |||||||||||||||||||||||||||||||||||
2 | 9 | 15E | 38 CC MO ND | 5710 | 5710 | 0.215 | |||||||||||||||||||||||||||||||||||
2 | 1 | 15E | 38 CC MO ND | 5720 | 5720 | 0.133 | |||||||||||||||||||||||||||||||||||
2 | 11 | 15E | 38 CC MO ND | 5530 | 5690 | 0.107 | |||||||||||||||||||||||||||||||||||
2 | 12 | 15E | 38 CC MO | 5745 | 5825 | 0.227 | |||||||||||||||||||||||||||||||||||
2 | 13 | 15E | 38 CC MO | 5755 | 5795 | 0.227 | |||||||||||||||||||||||||||||||||||
2 | 14 | 15E | 38 CC MO | 5775 | 5775 | 0.092 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15C | CC | 2402 | 2480 | 0.008 | |||||||||||||||||||||||||||||||||||
3 | 2 | 15C | CC MO | 2412 | 2472 | 1 | |||||||||||||||||||||||||||||||||||
3 | 3 | 15C | CC MO | 2422 | 2462 | 0.494 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
4 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0160000 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
5 | 1 | 15E | 38 CC MO | 5180 | 5240 | 0.161 | |||||||||||||||||||||||||||||||||||
5 | 2 | 15E | 38 CC MO | 5190 | 5230 | 0.153 | |||||||||||||||||||||||||||||||||||
5 | 3 | 15E | 38 CC MO | 5210 | 5210 | 0.021 | |||||||||||||||||||||||||||||||||||
5 | 4 | 15E | 38 CC MO ND | 5260 | 5320 | 0.159 | |||||||||||||||||||||||||||||||||||
5 | 5 | 15E | 38 CC MO ND | 5270 | 5310 | 0.166 | |||||||||||||||||||||||||||||||||||
5 | 6 | 15E | 38 CC MO ND | 5290 | 5290 | 0.027 | |||||||||||||||||||||||||||||||||||
5 | 7 | 15E | 38 CC MO ND | 5500 | 5700 | 0.108 | |||||||||||||||||||||||||||||||||||
5 | 8 | 15E | 38 CC MO ND | 5510 | 5670 | 0.119 | |||||||||||||||||||||||||||||||||||
5 | 9 | 15E | 38 CC MO ND | 5710 | 5710 | 0.215 | |||||||||||||||||||||||||||||||||||
5 | 1 | 15E | 38 CC MO ND | 5720 | 5720 | 0.133 | |||||||||||||||||||||||||||||||||||
5 | 11 | 15E | 38 CC MO ND | 5530 | 5690 | 0.107 | |||||||||||||||||||||||||||||||||||
5 | 12 | 15E | 38 CC MO | 5745 | 5825 | 0.227 | |||||||||||||||||||||||||||||||||||
5 | 13 | 15E | 38 CC MO | 5755 | 5795 | 0.227 | |||||||||||||||||||||||||||||||||||
5 | 14 | 15E | 38 CC MO | 5775 | 5775 | 0.092 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
6 | 1 | 15B |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC