Yushan Series X-Ray ay Flat Panel Detector Dete tor Operation Manual InnoCare Optoelectronics Corp.
Radiologist or any other practitioners licensed should ensure that they have adequate knowledge of the operation prior using the Yushan X-Ray Ray Flat Panel Detector. This Operation Manual should be studied and understood before proceeding to operate erate the equipment on patients; it describes details deta on how to operate the Yushan X-Ray Ray Flat Panel Detector and cautions to be observed when operating it.
Table of Content Chapter 1 Introduction............................................................................................. 6 1.1 1.2 1.3 1.4 Product Introduction ............................................................................ 7 Product Series ....................................................................................... 7 Product Indications for Use ............................................................... 7 Product Significant Performance Characteristics .............
2.17.5 Adapter Specification Label..................................................... 27 2.17.6 Safety Symbols ........................................................................... 28 3.1 How to Connect FPD ............................................................................... 29 3.2 Unit Names and the Functions ............................................................. 30 3.2.1 Flat Panel Detector ....................................................................... 30 3.2.
A.1 Specifications ........................................................................................... 63 A.1.1 Reduced Equivalent..................................................................... 63 A.1.2 Power Supply Conditions when Using Back-up Cable ...... 63 A.1.3 Power Supply to Battery Charger ............................................ 64 A.1.4 Power Consumption and Battery Specification ................... 64 A.1.5 Environmental Conditions ..............................................
Chapter 1 Introduction This manual is intended to provide the operator with an overview of the operation and safety requirements for the Yushan X-Ray Ray Flat Panel Detector. This manual iss not intended to provide instructions on actual treatment procedures and it is expected that users should have official radiologist or any other practitioners license prior to using the device.. The Manufacturer and Distribution organization assume no liability liab through ugh the use of the device.
1.1 Product Introduction Yushan X-Ray Flat Panel Detector is an X-ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and an X-ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic. Each X ray photon will be converted to electronic signal by scintillator and the sensor array. Electronic signal in the pixel will be readout by driver IC and then become an image before send to PC. 1.
0.23 @ 2 lp/mm 0.11 @ 3 lp/mm CsI 0.51 @ 0.5 lp/mm 0.48 @ 1 lp/mm 0.39 @ 2 lp/mm 0.29 @ 3 lp/mm DQE (Detector quantum efficiency) (Typical) GOS 0.31 @ 0.5 lp/mm 0.27 @ 1 lp/mm 0.16 @ 2 lp/mm 0.09 @ 3 lp/mm Maximum linear dose (Typical) 88 uGy Sensitivity (Typical) Dark noise (Typical) CsI 574 lsb/uGy GOS 592 lsb/uGy CsI 4.5 LSB GOS 7.9 LSB Lag <0.5% after 1 minute 1.
1.
1.9 Product Features - 140 micron pixel pitch - Wide image - 16-bit dynamic range output - Exposure times up to 3.0 seconds - Wireless communication mode or wired communication mode is available. When used in wireless communication mode, an access point and battery pack (optional) are required. 1.10 Clinical Guide Users may require to attend the traning courses held by InnoCare before using.
Chapter 2 Safety and Regulatory This Yushan X-Ray Flat Panel Detector has been designed and tested to function in a safe and correct when used as indicated in this manual. Do not use this device before reading and completely understand this Operation Manual. Always observe precautions for safety and only operates the device in a qualified room that provides protection. 2.1 Compliance Standards and Classification 2.1.1 Compliance Standards - FDA Standards 21 CFR 1020.
2.1.2 Classification - Type of protection against electrical shock: Class I Equipment Degree of protection against a electrical shock: Type B Equipment pment Degree of protection against harmful ingress of water: IPX6 (An IPX6 rating does not indicate compliance with, and the detectors have not been tested for compliance with, any other IPX_ ratings.) ratings.
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.
packs are not attached, an electric shock may result. Make sure to use the optional parts and accessories provided by InnoCare. InnoCare Failure to use the optional parts and accessories recommended by us may result in damage to the equipment and/or electric shock and injury. injury. Keep the equipment away from patient’s body fluids, chemicals, water, etc. Otherwise, it may be damaged, causing fire or electric shock. If necessary, protect the flat panel detector by covering it with a disposable bag.
- Where the equipment is exposed to direct sunlight. Use the equipment on a flat place. If the equipment falls, it may cause damage to the equipment or personal injury. When you move the equipment, place it in the cassette storage box of a mobile X-ray ray unit or hold it by hand to prevent it from falling. If the cart is used to move the equipment, place it horizontally. For veterinary or mobile applications, contact contact our official dealer or InnoCare I Representative.
Caution 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 measures if necessary. The setting change may include the following: - Change of connection destination Addition of devices Removal of devices - Update of devices Upgrade of devices After connecting this system to the network with other systems, confirm that the other systems are not affected.
When it is necessary to install authorized accessories or optional items, contactt our official dealer or InnoCare I Representative. Keep equipment ment other than those used for patients out of their reach to ensure appropriate system isolation. In normal use, have a patient take a proper positioning for exposure. The operator should operate the system in a place where safety from radiation is ensured. d.
Do not use e the following disinfectants at the time of disinfection, which the quality, performance and safety of the equipment cannot be assured. - Chloric disinfectant which is strongly corrosive corrosive to metals and rubber parts. Disinfectant whose uses on metals, plastics, and coating are forbidden according to the instructions supplied with the disinfectant. - Formalin gas and disinfectant sprays that may get inside the equipment. - Ultraviolet sterilizers lizers.
To charge the battery pack, be sure to use the designated battery charger and to observe the charging conditions specified by InnoCare e Optoelectronics Corp.. If the battery pack is charged in other conditions (temperature or voltage/current higher than th specified, remodeled battery charger, etc.
Do not leave the removed battery pack in the car or other places exposed to high temperature. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid. Use or store the battery pack only in the environmental conditions specified by InnoCare. If the battery pack is used or stored in a place where it is exposed to high temperature, the battery pack may emit smoke, ignite, explode or leak fluid.
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.
Wash the eyes immediately with clean water such as tap water, and consult a doctor. Otherwise, eye injury may result. Do not use the battery pack in combination with a primary battery such as a dry battery or other battery of a different capacity, type and/or brand. Otherwise, the battery pack may be overcharged during charging, and abnormal chemical reactions may occur inside the battery pack, causing causing it to overheat, emit smoke, explode or ignite.
Studies show that children are more radiosensitive than adults (i.e. children are at higher risk of developing developing cancer compared to adults exposed to the same dose of ionizing radiation). Accordingly, in pediatric use, special attention needs to be paid to avoid unnecessary exposure.
maintenance. In addition, this equipment should not be used by persons other than doctors or suitably trained staff. Be careful not to expose the flat panel detector to X-ray without a subject. Although the flat panel detector conforms to IPX6, no warranty is given as to the prevention of water intrusion in the flat panel detector. If the flat panel detector is splashed with water, wipe off moisture and ensure that the flat panel detector is completely dry before use.
The information of each label can be found in this section and the corresponding location are also presented as the following figure. The following labels are adhered to the Yushan X-Ray Flat Panel Detector. 2.17.
Yushan V17C Yushan V17G 2.17.
2.17.3 Battery Label 2.17.4 Packing Carton Label 2.17.
2.17.6 Safety Symbols The following safety symbols are used in the labels or on its body.
Chapter 3 System Configuration onfiguration 3.1 How to o Connect C FPD Yushan FPD can be operated either in wireless connection mode or wired connection mode. When using wired mode, back-up back up cable is necessary to provide the link from FPD to network switch hub or to PC. User can also connect back-up up cable to the adapter provided by InnoCare to give the power to operate or charging its battery. If the adapter ad is not connected, FPD will be powered by its own battery.
3.2 Unit Names and the Functions 3.2.1 Flat Panel Detector Unit names and the functions of the Yushan FPD are described below. 1. Applied part 2. LED indicator 3. Power button 4. Back-up cable connector 5.
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. Input : 100-250V ~ 1.5-0.75A 50-60Hz Output : 24V ⎓ 2.
Battery (Optional) Description: Rechargable Li-Ion battery designed for Yushan FPD. - Capacity: 4212 mAh - Rating voltage: 11.
Power Cord Description: Connection between AC inlet and adapter input. EU - PLUG : 6A/250V, CONNECTOR: 10A/250V - Length : 3M - PLUG : 10A/125V, CONNECTOR: 10A/125V Length : 2.5M US _____________________________________________________________ Note: Every provided accessory is identified to have not received prior 510(k) clearance. Do not use parts or accessories which are not certified by InnoCare Optoelectronics Corp. or not approved by CE or FDA.
3.3 LED indicators 4 LED indicator are on the side of Yushan series FPD. The behavior and the relations to the FPD status are described in the table below.
Chapter 4 Basic Operation O 4.1 .1 Preparing the Flat Panel Detector This section describes how to prepare the flat f panel detector. 4.1.1 .1.1 Type of Flat Panel Detector Yushan V14C, Yushan V14G, V14G Yushan V17C, Yushan V17G 4.1.2 .1.2 Number of the Connectable Flat Panel Detector Up to 5 panels can connect to system at the same time. 4.1.3 .1.3 Connecting/Disconnecting the Flat Panel Pane Detector Do not place the connector on floor.
_____________________________________________________________ Caution Do not place the connector c on a hard surface such as 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 sensor by holding only the connector connector. _____________________________________________________________ 4.1.4 Charging the Battery Pack for the Flat Panel Detector Use the battery charger recommended by InnoCare oCare Optoelectronics Corp.. Corp.
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 Step Following the picture and install the battery. 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.
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.
4.2.2 Wireless connection SDK command is used to setup SSID and password of wireless access point. This setup to FPD need to be done first before wireless connection. (Note: SDK is enclosed in the packaging) Users can set client mode parameters through the software interface. Choose wireless in configuration interface. Choose the “Client”.
Set the SSID and pass phrase of AP to be connected to the product. 4.2.3 AP mode connection Users can set AP mode parameters through the software interface. Choose wireless in configuration interface.
Choose the “AP”. Set the SSID and pass phrase of product. User needs to set the computer to the same domain as Yushan (Wifi). First, open the IPV4 of computer's local network management interface, and change the IP address to 192.168.11.1 and subnet mask to 255.255. 255.0.
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4.3 Starting Up and Shutting Down the Yushan FPD This section explains how to start up and shut down the Yushan. 4.3.1 Starting Up the Yushan 1. Press the power button for more than 2 second to start the FPD. 2. Make sure that the power LED light in green. 3. Power LED will still light in green. Wait status LED stop flashing. 4.
4.3.2 Overview of User Interface Operation o Enter Operation: Make FPD enter operation state. User can choose exposure mode after FPD is in operation state. o Exit Operation: Make FPD exit operation state. o Set FPD time: Synchronize the time between PC and RTC of FPD. Mode o Start: Make FPD operate in selected exposure mode. o Stop: Make FPD stop selected exposure mode and return to Idle in operation state. o Reset: Reset the image module (Clear some alert flag).
4.3.3 Search and connect FPD Click 1 to discover all reachable FPDs Expand the selected entry of the list, and select connection by Ethernet or Wifi. Then click 2 to connect the specified FPD. Note: Please make sure the IP of Host PC and the selected connection is in the same local area network. 4.3.3.1 .3.1 Wireless connection Expand the selected entry of the list, and select connection by Ethernet. Then click 2 to connect the specified FPD.
After establishing the connection, you can check the diagnosis field on the right to confirm the information of Yushan products. The message appears to indicate a successful connection. After connection is established, you can use 3 to disconnect the FPD. Note: Connecting to other FPD disconnect the currently connected FPD automatically 4.3.
4.3.5 Performing an Exposure and Image Acquistion When performing an exposure, make sure that the STATUS LED light in green and not flashing. Otherwise image may loss. 4.3.5.1 AED one shot mode - - - After selecting the AED one shot mode, press Start. When FPD is in AED one shot mode, it returns to operation mode after each X-Ray exposure is detected. User can use Stop to exit AED one shot mode before X-Ray exposure is detected.
- 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.
4.3.5.4 Other Operations - Discharge: Discharge panel. Acquisition: Discharge panel and acquire image immediately. Reset operation mode: If errors occur in the exposure workflow, user must use this button to reset.
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4.3.6 Download image from FPD Auto download The software has an automatic download function, as long as the automatic download is checked, the image can be automatically downloaded in modes other than AED repeat mode. - Image ready The image data is first stored in the DDR SDRAM and then transferred to the PC. When the status of image has been show “ready”, it means the images is already stored in the DDR SDRAM.
the DDR SDRAM. First, press (3) to list all the information of the image, and then press the arrow of (1) to output the original image to the PC. In addition, if there is an image with offset set at the beginning of the exposure, press the (2) arrow to output the offset image to the PC. 4.3.7 Shutting Down the Yushan Press the power button for more than 2 second to shut down the FPD.
4.4 Guidelines for Pediatric Applications InnoCare typically conducts radiologists(Government-certified) usability studies that compare Yushan detector models to the marketed devices. Participate radiologists have demonstrated that the images acquired using the Yushan detectors are deemed to be of diagnostic capability. Additionally, please review the following scientific literatures regarding pediatric (https://www.ncbi.nlm.nih.gov/pubmed/29064378) and neonates (https://www.ncbi.nlm.nih.
For system operation, ΑΕC must be used carefully, preferably use manual technique setting, applying lower doses. If possible, use high kVp techniques. Positioning the pediatric patient: Pediatric patients are not as likely as adults to understand the need to remain still during the procedure. Therefore it makes sense to provide aids to maintaining stable positioning. It is strongly recommended the use of immobilizing devices such as bean bags and restraint systems (foam wedges, adhesive tapes, etc.
4.5 Correction procedure _____________________________________________________________ Cautions This procedure should only be done by suitably-trained service engineer. _____________________________________________________________ Cautions If the exposure for the corrected images are collected by wrong exposure setting, for example, (A). Over-exposure Over than or under-exposure exposure (B). Foreign object is put on the surface (C) collimator of Xray tube is not open to the full field of FPD.
4.5.2 Correction process First get 16 dark images and 16 light images, sort and store the images in the same folder, and create another folder named "calib".And store the image to be corrected in the same folder and fill in the name of the folder. Click “ Noise ”: The “mode” represents the level of noise. The “ ()” represents the number of pixels.
Click “Gen Map”: Will output the map to be calculated Click “Correction” The Detector has been successfully corrected if a “correction of all raw images is complete” appears in the windows as seen in the figure.
4.5.3 .3 Storage of calibration data 10 sets of calibration data can be stored inside Yushan. Users can update or get calibration data for the product. After selecting the class of the map, click “File to send”. Click on the file to be updated to the inside of the product. Click “Set” and complete the update. _____________________________________________________________ Caution These actions are carried out by Authorized Personnels not End Users.
4.5.4 Standard Configuration A. Other Essential System Components necessary to perform Digital Radiography Yushan (Supporting SDK Interface) can be used in combination with the image processing unit provided by System Integrator. The X-ray equipment is composed of X-ray high voltage generator and X-ray console, etc. The hand switch is connected with the console for the exposure. At first, when making an exposure, press the Prep switch only of the hand switch.
C. System overview Transfer image data generated by Yushan to the memory within Host PC Generate an image file and information file. Yushan only provides raw file to system vendors.
Chapter 5 Daily Inspection and Maintenance 5.1 .1 Daily User Inspection and Maintenance During maintenance and inspection, strictly observe precautions contained in “Chapter Chapter 2 Safety and Regulatory” Regulatory in this is manual for you to use the device under best conditions. 5.1.1 .1.
Chapter 6 Troubleshooting - In case of smoke, fire, abnormal high temperature, remove battery and power supply and turn off detector imediately. - In case of yellow error LED on, it may trigger the impact. Please read the manual to release the status and restart the power; if the yellow light cannot be removed, contact InnoCare service engineer or local representative - In case of abnormal image, calibrate detector by standard method.
Appendix A Specifications of FPD A.1 Specifications Specifications of the Yushan are shown below. A.1.1 Reduced Equivalent Peak reduced equivalent on the front panel of the flat panel detector: 0.57 mmAl A.1.2 Power Supply Conditions when Using Back-up Cable The DC power supply to Yushan FPD is delivered with its AC/DC adapter. Item Min Input Voltage Range Max unit 80 264 VAC Nominal Input Frequency 50 60 hz Input Frequency Range 47 63 hz Output voltage Typ. 24 Output current VDC 2.
A.1.3 Power Supply to Battery Charger A 2-slot battery charger V14C/V14G/V17C/V17G. is provided along with the Yushan The battery charger is delivered with its AC/DC adapter which is the same as A.1.2. A.1.4 Power Consumption and Battery Specification Item Specification (typical) Unit Power (Operating) 16 W Power (Stand-by) 10 W Battery voltage 11.
image quality and electro-optical performances are not guaranteed. It also means that, except if mentioned explicitly, any perturbation occurring within those conditions are reversible and not existing anymore when the detector is turned back within the performance operating conditions. Item Min Temperature 5°C Humidity 15% Pressure 700mBar Typ.
Caution 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.
Item Min Typ. MTF @ 1 lp / mm 0.55 0.69 MTF @ 2 lp / mm 0.27 0.39 MTF @ 3 lp / mm 0.13 0.22 DQE @ 0.5 lp / mm 0.38 0.51 DQE @ 1 lp / mm 0.36 0.48 DQE @ 2 lp / mm 0.29 0.39 DQE @ 3 lp / mm 0.19 0.29 Max unit V14G/V17G (GOS Version) Performance at *RQA5 Item Min Typ. Max unit MTF @ 1 lp / mm 0.46 0.52 0.57 MTF @ 2 lp / mm 0.18 0.23 0.28 MTF @ 3 lp / mm 0.08 0.11 0.14 DQE @ 0.5 lp / mm 0.25 0.31 0.37 DQE @ 1 lp / mm 0.23 0.27 0.32 DQE @ 2 lp / mm 0.13 0.
DQE @ 3 lp / mm 0.06 0.09 *The above specifications have been verified by INX; The physical characterization of the systems was obtained with the standard beam conditions RQA5 (in accordance with IEC 61267:1994). A.1.7 Radio Waves Wireless specifications for the flat panel detector and the access point are as follows. Item Specification Wireless specification IEEE802.11 ac / a/g/n Transmit frequency 5.2, 5.3, 5.6, 2.4 GHz Antenna 2 Date rate 866Mbps (802.
A.2 External View and Weight Item Width Length (mm) Height (mm) Weight (Kg) Yushan V14C 460 383 15 2.7 Yushan V14G 460 383 15 2.7 Yushan V17C 460 460 15 3.1 Yushan V17G 460 460 15 3.
Appendix B Electromagnetic Compatibility (EMC) B.1 Yushan FPD This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2014/EN 60601 60601-1-2:2015. These limits are designed to provide reasonable reasonable protection against harmful interference in a typical medical installation.
B.2 Further Information for IEC 60601-1-2 2 (EN 60601-1-2) 60601 _____________________________________________________________ Caution This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments. _____________________________________________________________ 1.
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 Manufacturer’s declaration-electromagnetic emissions The Yushan V14C, Yushan V14G is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Yushan V14C, Yushan V14G should assure that it is used in such an environment.
healthcare environment) Electrostatic Contact:±8 kV Contact:±8 kV Floors should be wood, discharge(ESD) Air±2 kV,±4 kV,±8 Air±2 kV,±4 kV,±8 concrete or ceramic tile.
environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Manufacturer’s declaration-electromagnetic immunity The Yushan V14C, Yushan V14G is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Yushan V14C, Yushan V14G should assure that it is used in such and environment.
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Recommended separation distance between portable and mobile RF communications equipment and the Yushan V14C, Yushan V14G The Yushan V14C, Yushan V14G is intended for use in an electromagnetic environment (for professional healthcare) in which radiated RF disturbances are controlled.
Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The Yushan V14C, Yushan V14G is intended for use in the electromagnetic environment (for professional healthcare) specified below. The customer or the user of the Yushan V14C, Yushan V14G should assure that it is used in such an environment.
GSM 1800; CDMA 1 720 1 845 1 700 – 1 990 1 970 1900; GSM 1900; Pulse modulation b) DECT; LTE Band 1, 3, 217 Hz 0,3 28 28 2 0,3 28 28 0,2 0,3 9 9 4, 25; UMTS Bluetooth, WLAN, 2 450 2 2 400 – 2 570 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 5 240 5 500 5 100 – 5 800 WLAN 802.
Appendix C Radio Frequency (RF) Compliance Information 1. For U.S.A. and Canada Federal Communications Commission (FCC) Statement You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules.
uncontrolled environment. This equipment should be installed and operated with a minimum distance of 0 cm between the radiator and your body. 2. For European Union and EEA-EFTA Requirements in AT/BE/BG/CZ/DK/EE/FR/DE/IS/IE/IT/EL/ES/CY/LV/LI/LT/LU/ HU/MT/NL/NO/PL/PT/RO/SI/SK/TR/FI/SE/CH/UK/HR. 5150MHz~5350MHz is for indoor use only. SAR is measured with the device at 0 mm to the body, while transmitting at the highest certified output power level in all frequency bands of the device.
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