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1 2 | Test Report | |||||||
1 2 | External Photos | / July 09 2014 | ||||||
1 2 | Internal Photos | / July 09 2014 | ||||||
1 2 | ID Label/Location Info | |||||||
1 2 | Test Report | |||||||
1 2 | RF Exposure Info | |||||||
1 2 | Test Report | |||||||
1 2 | Test Setup Photos | / July 09 2014 | ||||||
1 2 | Test Setup Photos | / July 09 2014 | ||||||
1 2 | Parts List/Tune Up Info | |||||||
1 2 | RF Exposure Info |
1 2 | Users Manual | Users Manual | 5.16 MiB | / July 09 2014 |
Version 1 Date: 2014-03-24 1417WGC User / Installation Manual R-USM-020 1 Copyright 2014, Rayence Co. Ltd. All pages of this document contain proprietary and confidential information of Rayence Corporation and are intended for exclusive use by Rayence Corporation personnel or customers. Copying, disclosure to others or other use the express written authorization from Rayence Corporation. Please report any violations of requirement to Rayence Corporation. is prohibited without R-USM-020 2 Attention For improvement of product performance, supplementation, or follow-up of information; the contents of this manual are subject to change without separate prior notice. Please note that our company has neither responsibility for any accidents nor obligation to do free repair service for any damage of the equipment due to user's mistake, which resulted from failure to follow the contents in this manual. Make sure to be familiar with the safety precautions and usage procedures. Also note that the product may slightly differ from the contents of this manual depending on specification. The following marks are used for the effective use of the product in this manual. Attention, consult accompanying documents. This is used to emphasize essential information. Be sure to read this information to avoid incorrect operation. This indicates hazardous situation which, if not heeded, may result in minor or moderate injury to you or others, or may result in machine damage. This indicates a potentially hazardous situation which, if not heeded, could result in death or serious injury to you or others. Federal Law restricts this device to sale by or the order of a radiologist or any other practitioners licensed by the law of the state in which that person practices to use or order the use of the device. R-USM-020 3 Contents 4. 1. Introduction ................................................................................. 6
(1) Overview .................................................................................... 6
(2) Intended use .............................................................................. 6
(3) Product features ........................................................................ 7
(4) Product components ................................................................. 8
(5) Components Description ........................................................ 11
(6) Warning .................................................................................... 14
(7) Caution ................................................................................... 16 2. Notes for Using the Detector ..................................................... 19
(1) Preparing ................................................................................. 19
(2) Handling................................................................................... 21
(3) Before Exposure ...................................................................... 22
(4) During Exposure ..................................................................... 22
(5) Limit of Load ............................................................................ 23
(6) Disinfection and Cleaning ....................................................... 24
(7) Others ...................................................................................... 24 3. Technical Features .................................................................... 25
(1) Mechanical Features ............................................................... 25
(2) Electrical Features .................................................................. 25
(3) Environmental requirement .................................................... 29
(4) PC Requirements .................................................................... 29 Installation ................................................................................. 30
(1) Program setup ......................................................................... 30
(2) Connection (Manual Trigger) .................................................. 31
(3) Connection (Auto Trigger) ...................................................... 39
(5) IP set up ................................................................................... 44
(6) Using FPD_Manager (IP, SSID Change / Upgrade FW) .......... 45 5. Calibration ................................................................................. 51
(1) General Principle ..................................................................... 51
(2) Calibration ............................................................................... 53 Image Acquisition Test .............................................................. 58
(1) Get Image ................................................................................. 58
(2) View Images ............................................................................. 59
(3) Get Recent Frame .................................................................... 64 7. Operation ................................................................................... 65
(1) Recommend............................................................................. 65
(2) Switching power on / off ......................................................... 65
(3) Storage .................................................................................... 65 8. Safety Information ..................................................................... 66
(1) Safety standard ....................................................................... 66
(2) Electromagnetic Compatibility Information ........................... 68 9. Radio Frequency compliance .................................................... 73 FCC Notice (U.S.A) .................................................................. 73
(1)
(2) IC Notice (CANADA) ................................................................ 75
(3) R&TTE Notice (European Union) ............................................ 76 10. Maintenance .............................................................................. 77 6. R-USM-020 4
(1) Maintenance ............................................................................ 77
(2) Cleaning ................................................................................... 77
(3) Inspection ................................................................................ 78
(4) Disposal or Recycling ............................................................. 79
(5) Marking and labeling symbols ................................................ 80 Appendix ........................................................................................... 82 R-USM-020 5 1. Introduction
(1) Overview The 1417WGC is a wireless digital X-ray flat panel detector that can generate images of any part of the body. The wireless LAN((IEEE 802.11a/g/n) communication feature improves the operability, and high-speed processing. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images.
(2) Intended use Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography. intended is It R-USM-020 6
(3) Product features Wi-Fi (802.11a/g/n) Based on a-Si TFT active matrix Compact (15.4mm thickness) and light weight (Typ. 3kg) Limiting Resolution : 3.9 lp/mm 14/16-bit digital output Easy integration R-USM-020 7
(4) Product components Medical Image Processing Unit Photo Item Part Name Quantity Detector RD1417WGC 1 Battery pack RB37WHA 2 Battery charger RC120WA 1 Charger adapter PMP120-13-3 1 AGI RA001A Power box supply RP003A 1 1 8 R-USM-020 Cables Item Part Name Length Quantity Link cable 7m 1 P-
Interface cable USB cable(A to B) VRH017A 8m 1 VRH078A 1.8m 1 LAN cable VRH027A 10m 1 AC Power cord VRH018A/019A 1.8m 2 Installation CD o Manual o Detector Library R-USM-020 9 Option o Additional Battery o Trigger cable R-USM-020 10
(5) Components Description The detector is designed to capture radiographic images. Captured images are transmitted to PC using the wireless/wired connection.
(1) Detector 1. Wireless antennas The module adopts the latest 802.11n Dual-Band technology
(2.4Ghz and 5Ghz). The transmitter of the module is powered by host equipment(Detector). The antennas are 2 printed-dipole antennas.
*Wireless module information:
The SparkLAN WPEA-121N 802.11 a/b/g/n half mini PCI-e module is implemented. It supports 2T2R (2 transmit 2 receive) MIMO technology, which delivers throughput up to 300Mbps. 1417WGC in the RF module does not use DFS band.
*RF module (FCC ID: PPD-AR5BHB116) 2. Battery unlock-lever : This is an unlock-lever to remove battery. 3. Power button : Power on / Power off switch. 4. LED indicator: The LED indicates the state of detector. i. Green on : Power on. ii. Blue blinking : Wireless Connection. iii. Orange on : Low battery. 5. Link cable connector : This is a connector for wire communication and power supplying. Connect the detector to the power supply using Link cable. 6. Reset button : This is a button for factory reset. R-USM-020 11
(2) Battery & Charger 1. Battery : Lithium ion battery. The number of times being acquired image is 960 images(@ cycle time : 15s). The batteries are rechargeable The charging time = 3 hours. 2. Charger : Two port cradle type. 3. LED indicator :
i. Orange on : charging ii. Green on : Charging is completed.
(3) AGI 1. Trigger connector: This is a connector for synchronization between detector and generator. Connect the AGI to the generator using P-interface cable or trigger cable 2. USB connector: This is a connector for communication between AGI and PC. Connect the AGI to the PC using USB cable. R-USM-020 12
(4) Power supply box 1. Power plug connector: Connect with AC power supply cord 2. LAN connector : Ethernet port for transmitting the image/command between detector and PC 3. Link cable connector: Power connector for detector operating 4. LED indicator: Four LEDs to display the status Changeable part: Fuse T3.15 AL 250V R-USM-020 13 Make sure to observe the following right
(6) Warning Environment of Use and Storage Follow the specified process of operational instructions written in this manual for the safety of the users and patients. Does not use or store the instrument near any flammable chemicals such as thinner, benzene, etc. Also, this instrument is not a category AP or APG equipment. If chemicals are spilled or evaporate, it may result in fire or electric shock through contact with electric parts instruments. Also, some disinfectants are flammable. Be sure to take care when using them. inside the Connection Do not connect the instrument with anything other than specified. Otherwise, it may result in fire or electric shock. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Wireless connection SSID & PSK value should match to Routers setting. (Refer to the Ch.4.(2)). If these values are not matched with Detector and Router, the connection is not allowed for security. Avoid using co-channel or adjacent-channel with other wireless devices for high quality wireless performance. Handling Always be sure to keep checking the condition of the system and the patient to ensure they are normal during the use of the instrument. If any problem is found, take appropriate measures, such as stopping the operation of the instrument, as required. R-USM-020 14 Never disassemble or modify the product as it may result in fire or electric shock. Also, since the instrument incorporates parts that may cause electric shocks and other hazardous parts, touching them may cause death or serious injury. Do not hit or drop the instrument. The instrument may be damaged if it receives a strong jolt, which may result in fire or electric shock if the instrument is used without being repaired. When Problem Occurs Should any of the following occur, immediately turn OFF the power of each instruments, unplug the power supply cord from the AC outlet, and contact Rayence representative or distributor. When there is smoke, odd smell or abnormal sound. When liquid has been spilled into the instrument or a metal object has entered through an opening. When the instrument has been dropped and it is damaged. Maintenance and Inspection For safety reasons, be sure to turn OFF the power of each instrument when the inspections indicated in this manual are going to be performed. Otherwise, it may result in electric shock. When the instrument is going to be cleaned, be sure to turn OFF the power of each instrument, and unplug the power supply cord from the AC outlet. The instrument must be repaired by a qualified engineer only. If it is not repaired properly, it may cause fire, electric shock, or accident. R-USM-020 15
(7) Caution Environment of Use and Storage Do not install the instrument in a location with the conditions listed below. Otherwise, it may result in failure or malfunction, cause fire or injury. Close to facilities where water is used. Where it will be exposed to direct sunlight. Close to air-conditioner or ventilation equipment. Close to heat source such as a heater. Make sure to observe the following right. Prone to vibration. Insecure place. Dusty environment. Saline or sulfurous environment. High temperature or humidity. Freezing or condensation. Do not place the storage case in a location with the conditions listed below. Where the cable of the sensor unit will be strongly pulled when the sensor unit is put into the case, otherwise, the cable may be damaged, resulting in fire or electric shock. Where someone might get their foot caught in the cable of the sensor unit. Otherwise they could trip over, resulting in injury Non-medical equipment such as the battery charger, access point cannot be used in patients vicinity. R-USM-020 16 Handling Do not spill liquid or chemicals onto the instrument or, in cases where the patient is injured, allow it to become wet with blood or other body fluids, as doing so may result in fire or electric shock. In such situation, protect the instrument with disposable covering as necessary. Wipe the CFRP plate of the sensor unit with ethanol or glutaraldehyde solution to disinfect it each time a different patient uses the instrument, in order to prevent infection. Turn off the power of each instrument for safety when they are not going to be used. This device is contraindicated in pregnant woman. Maintenance and Inspection For safety reasons, be sure to inspect the instrument before using it. In addition, carry out a regular inspection at least once a year. Modifications Any changes or modifications in construction of this device which are not expressly approved by for compliance could void the user's authority to operate the equipment. the party responsible Battery Do not let the detector or battery come in contact with liquids. Liquids can get into the detectors circuits, leading to corrosion. Even when the detector appears to be dry and appears to operate normally, the circuitry could slowly corrode and pose a safety hazard. If the detector and/or battery get wet, have them checked by your service provider or contact Rayence, even if they appear to be working properly. R-USM-020 17 Do not place your battery in or near a heat source. Excessive heating can damage the detector or the battery and could cause the detector or the battery to explode. Do not dry a wet or damp battery with an appliance or heat source such as a microwave oven, hair dryer, iron, or radiator. Do not dispose of the detector or the battery in a fire. The detector or the battery may explode when overheated. Never use any charger or battery that is damaged in any way. Important! Use only Rayence-approved batteries, and recharge your battery only with Rayence-approved chargers which are specifically designed for your detector. Use of a non-Rayence-approved battery or charger may present a risk of fire, explosion, leakage, or other hazard. Rayence's warranty does not cover damage to the detector caused by non-Rayence-approved batteries and/or chargers Misuse or use of incompatible batteries and charging devices could result in damage to the equipment and a possible risk of fire, explosion, or leakage, leading to serious injuries, damages to your detector, or other serious hazard. Check the battery status frequently to avoid battery empty. (Refer to the Ch.3.(2) Electrical Features) When the low battery LED of detector is turned on, change the battery or charge the battery using cable R-USM-020 18 2. Notes for Using the Detector
(1) Preparing Fully charge the battery pack. Charge the battery on the day of examination or on the previous day. Battery slowly discharges even of not in use. The battery pack may have expired if it discharges immediately after being fully charged. You can purchase an optional battery pack to replace an exhausted one. Be sure to fully charge the battery before use. The battery charger, RC120WA is designed for the dedicated battery pack. When the detector will not be used for some time, remove the battery pack. Attach the battery pack. Align the claw on the battery pack and the groove on the battery bay. Insert the battery pack fully. Push down the battery pack and cover.
<Insert battery>
R-USM-020 19
<Remove battery>
R-USM-020 20
(2) Handling Handle the instrument carefully, as it may be damaged if something is hit against it, dropped, or receives a strong jolt. R-USM-020 21
(3) Before Exposure Be sure to check the equipment daily and confirm that it works properly. in cold areas will cause Sudden heating of condensation to form on the instrument. In this case, wait until condensation disappears before performing exposure. room the Room temp. 70 / 21 is recommended. If the instrument is used with condensation formed on it, problems may occur in the quality of the instrument. When an air-
conditioner is going to be used, be sure to raise/lower the temperature gradually so that a difference in temperature in the room and in the instrument does not occur, to prevent forming of condensation.
(4) During Exposure Do not use the detector near devices generating a strong magnetic field. Doing so may produce image noise or artifacts. Do not apply excessive weight to the sensor unit. Otherwise, the sensor may be damaged. R-USM-020 22
(5) Limit of Load Uniform load: 150 kg over the whole area of sensor window. Local load: 100 kg on an area 40 mm in diameter. Be sure to use the sensor unit on a flat place so it will not bend. Otherwise, the sensor may be damaged. R-USM-020 23
(6) Disinfection and Cleaning Do not spray the detector directly with disinfectants or detergents. Do not use anything other than neutral detergent for cleaning the cover of the instrument. Otherwise, the coating will be corroded.
(7) Others Be sure to reconnect the cables to the proper connectors. Otherwise, the instrument may malfunction or may be damaged. R-USM-020 24 3. Technical Features
(1) Mechanical Features 460 x 384 x 15.4 mm Size Weight Encapsulation Material Carbon fiber plate with 1.8 mm thickness Window Material Carbon fiber plate with 1.8 mm thickness 3 kg
(2) Electrical Features Detector Sensor Type Amorphous Silicon with TFT (Single Panel) X-ray Converter Gd2O2S:Tb Total Pixel Number 3328 2816 pixels Total Pixel Area 422.7 x 357.6 mm Effective Pixel Number 3268 2756 pixels Effective Pixel Area 415.0 x 350.0 mm Pixel Pitch 127 m Limiting Resolution Energy Range A/D Conversion Preview Time Max. 3.9 lp/mm 40 - 150 kV 14/16 bits
< 2.0 sec (wired)
< 5.0 sec (wireless) Data Interface
- Wireless Wi-Fi (802.11a/g/n)
- Wired Gigabit Ethernet Power consumtion Typ. 15W (Max. 30W) Under RQA5 condition (70kVp, 21mmAl) Preview time is not included post-processing time R-USM-020 25 Power Supply Size Weight Input Output Battery Size Weight Input Output Charging time Capacity The number of times being acquired image 188 x 92 x 41.5 mm 0.46kg 110~220VAC (50/60Hz) Typ. 24VDC (Max 1.9A) 263.2 x 127.8 x 6 mm Typ. 0.3 kg 12.5 VDC 11.1 VDC Typ. 3 hours Typ. 3400 mAh 960 images (@cycle time = 15s) The Battery level can be displayed on the LED status of battery. If the battery level goes down under 25%, please charge the battery Display Battery level 75~100 %
50~75 %
25~50 %
0~25 %
200 x 100 x 150 mm Typ. 0.85 kg 20 VDC 12.5 VDC Charger Size Weight Input Output R-USM-020 26 Adapter Size Weight Input Output 160 x 76 x 43.7mm (cable length: 1.28m) Typ. 0.73 kg 100~240 VAC, 47~63 Hz, 1.4~0.6A 20 VDC, Max 6.0A R-USM-020 27 Wireless Spec Standard Peak Rate Frequency Bandwidth MIMO 802.11a/g/n compliance Without DFS (5.25GH to 5.35GHz and 5.47 to 5.725) Band 300Mbps 2.4 GHz / 5 GHz 20MHz/40MHz 2x2 Recommended Maximum operable distance : 10m
(From the Access Point) 5150~5250 MHz band is restricted to indoor operations only. (for FCC) 5150~5250 MHz band is restricted to indoor operations only. (for CE) 5150~5250 MHz is indoor use only. (for Japan) R-USM-020 28
(3) Environmental requirement Item Min. Typ. Max. Unit Note Temperature
(Storage) Temperature
(Operation) Humidity
(Storage) Humidity
(Operation) Vibrations
(Wrapping condition)
-10 5 10 30 50 40 80 75
H.R.
H.R. 2G
(8G) 10-150Hz, 10Sweeps, 1min/Octave, XYZ axis Regularly changed parts : Battery (warranty 6 months)
(4) PC Requirements Processor: At least Intel Pentium IV HT with 2.8GHz, Intel Core Duo / Core 2 or comparable AMD Dual Core processor At least 3GB of RAM requirement (4GB for 32 BITS OS and 8GB for 64 BITS OS recommended) At least 500GB for application and archiving. Recommended 500GB for applications and secondary drive of 1TB for image archiving.. Dual 10/100/1000 network card system required. One for network (Internet) and one for the DR Panel communication Graphics card / monitor: Resolution of at least 1,600 x 900 for desktop and 1366 x 768 for laptop. For diagnostics purpose we recommend 1920 x 1080 resolution (2 mega pixels) monitor Microsoft Windows 7 32BIT/64BIT No antivirus except for Microsoft Security Essentials. R-USM-020 29 4. Installation Portable Imaging processing unit must be installed in a way that enables the user to achieve optimal use The Detector is composed of sensitive electronic parts and components. It is recommended to use the product in a clean place and to exercise caution to ensure that it is not affected by dust or liquids. It is recommended to Use a dry and soft cloth to clean the detector housing.
(1) Program setup Detectors IP : Wireless - 2.2.2.100 Wired 2.2.2.101 Detectors number of ADC : 0 Detectors size of image : 3328x2816 Figure 1: Setup R-USM-020 30
(2) Connection (Manual Trigger) Power Connection A. Connect the battery pack or power cable to the equipment.
* In wired mode, the frame ground is necessary. B. Connect the USB cable from your PC to AGI. Be sure to sure only the dedicated battery pack, RB37WH for 1417WGC. Wireless Communication R-USM-020 31 A. AP Router(Line sharer) setting
- SSID : Griffon
- Internal network
- IP address : 2.2.2.1
- Subnet mask : 255.255.255.0
- Dynamic IP allocation range : 2.2.2.2~2.2.2.254
- Pre-Shared Key(Password) : project302
- Authentication methods : WPAPSK or WPA2PSK
- Password methods : TKIP/AES
- AP IP : 2.2.2.1
- Channel (Frequency)
- Avoid crowded channel
(Using wireless detector under crowded channel result in low performance)
- If available, Use Auto-Channel Selection function of router to find optimal channel B. Reception Indicator Link LED flickering Blink Speed : Slow Low link quality Fast High link quality C. Checking Link Quality & Battery Remain R-USM-020 32
- After wireless connection is established, perform Get Bright in Calibration tap.
- Check the value named Wireless Signal in black log screen. Wireless Signal = Link Quality (Max. 100)
- Check the value named Battery Remain in black log screen. Battery Remain = Battery Remain(Max. 100) The value Wireless Signal will be displayed here R-USM-020 33 Software Setting Figure 2: Davinci Setting R-USM-020 34 Trigger Connection A. Connect the P-interface cable or trigger cable to the generator X-ray Generator Connection A. Mode 1 : P-interface cable mode Connect the P-interface cable between the AGI box and X-ray generator. Make assurance doubly sure SIGNAL RATING before connection. Operating description R-USM-020 35 Exposure Time(*clk) 4999999 is designate to 0.5sec The window time can be changed. Refer to the following pictures R-USM-020 36 Make assurance doubly sure SIGNAL RATING before connection. B. Mode 2 : Trigger cable mode Connect the Trigger cable between the X-ray enable connector of AGI with X-ray generator. AGI Figure 8: <2nd example> wiring for the interface between portable generator & detector Connection description Signal New Label Old Label Color Input / Output READY IN 12V~24VDC R.E.C. +12-24V READY IN Ready Input Signal Red Black READY DONE READY DONE COM Table 3 : Connection description READY DONE Exposure Output SW1 Green Exposure Output SW2 Blue Input Input Output Output R-USM-020 37 Operating description Figure 3 : Timing chart t1: It will be occurred when exposure switch is pushed completely after. t2: Window time of detector is varying 0 sec ~ 5 sec. which can be control by S/W. (Editing parameter: Exposure Time Refer to the NOTE) Expose relay switch ON time (Window Time) and X-ray exposure time must be same. t2 time can be control by S/W The window time can be changed. Refer to the following pictures Exposure Time(*clk) 4999999 is designate to 0.5sec R-USM-020 38
(3) Connection (Auto Trigger) Power Connection A. Connect the battery pack or power cable to the equipment.
* In wired mode, the frame ground is necessary. Be sure to sure only the dedicated battery pack, RB37WH for 1417WGC. R-USM-020 39 Wireless Communication A. AP Router(Line sharer) setting
- SSID : Griffon
- Internal network
- IP address : 2.2.2.1
- Subnet mask : 255.255.255.0
- Dynamic IP allocation range : 2.2.2.2~2.2.2.254
- Pre-Shared Key(Password) : project302
- Authentication methods : WPAPSK or WPA2PSK
- Password methods : TKIP/AES
- AP IP : 2.2.2.1
- Channel (Frequency)
- Avoid crowded channel
(Using wireless detector under crowded channel result in low performance)
- If available, Use Auto-Channel Selection function of router to find optimal channel B. Reception Indicator Link LED flickering Blink Speed : Slow Low link quality Fast High link quality R-USM-020 40 C. Checking Link Quality & Battery Remain
- After wireless connection is established, perform Get Bright in Calibration tap.
- Check the value named Wireless Signal in black log screen. Wireless Signal = Link Quality (Max. 100)
- Check the value named Battery Remain in black log screen. Battery Remain = Battery Remain(Max. 100) The value Wireless Signal will be displayed here R-USM-020 41 Software Setting Figure 4: Davinci Setting R-USM-020 42 Important Note In AUTO TRIGGER MODE, the trigger will be forced not to acquire images when detector senses vibration or shock. In READY mode, Detector will automatically switch to WAIT mode when detector senses vibration or shock, so that user wont acquire images in WAIT mode although X-ray exposure applies. WAIT mode switches back to READY mode after 2-3 seconds. If you dont want to use ANTI-SHOCK FUNCTION, please click OPTION 1c IF you dont use ANTI-SHOCK FUNCTION, you are able to get images regardless detector senses vibration or shock. However, you should keep in mind there is also a possibility images can be acquired by vibration or shock without X-ray exposure. R-USM-020 43
(5) IP set up
[My Network Places] [Properties] [Local Area Connection]
[Properties] [Internet Protocol (TCP/IP)]
[Use the following IP address]
IP address: Obtain an IP address automatically IP address : Obtain an IP address automatically R-USM-020 44
(6) Using FPD_Manager (IP, SSID Change / Upgrade FW) Change IP Address of Detector A. Turn on Detector and connect to PC
(wired connection is recommended) B. After detector boot up, Launch FPD_Manager.exe R-USM-020 45 C. Check the IP Change and type current IP address as below D. Type IP address to set R-USM-020 46 E. Click Start Setting button F. Restart detector(Turn Off then On) Change SSID and PSK(Pre-Shared Key) A. Turn on Detector and connect to PC
(wired connection is recommended) B. After detector boot up, Launch FPD_Manager.exe R-USM-020 47 C. Check the SSID change and write current IP address as below D. Type SSID and PSK to set R-USM-020 48 E. Click Start Setting button F. Restart detector(Turn Off then On) Upgrade Firmware A. Turn on Detector and connect to PC
(wired connection is recommended) B. After detector boot up, Launch FPD_Manager.exe R-USM-020 49 C. Check the SSID change and write current IP address as below D. Select firmware or FPGA file by click select button. Click Start Setting button E. Restart detector(Turn Off then On) R-USM-020 50 5. Calibration X-ray detector should be used at stable state within driving temperature range. Acquire the X-ray images after power on and 5 minutes warming up to obtain high quality images.
(1) General Principle Notation Calibration can be done by image acquisition S/W. The gain-
offset correction (under calibration) will be done with one dark, at least one bright and object frame. Parameter Description Offset Bright Object Gain Dark image, acquired image without X-ray exposure Acquired image with X-ray exposure Bright image with object, will be calibrated Gain of imaging system, offset subtracted image Offset correction Offset subtract Gain correction Compensate gain variance of pixel R-USM-020 51 The calibration range of bright is can be select by which exposure level is maximum level that user want to use. If the maximum level of user want to use is 6500 in this case the level is contained in Bright point of 3(refer Table 5 : Median value). The meaning is you dont have to make bright point for 4(In this case, it will be does not working if you get image on higher level than maximum bright point.) Bright Calibration Point To gain correction, bright frame and dark frame should be acquired. The dark frame is needed only one frame. The bright frame is recommended to be acquired more than 2 different levels of median values of bright frames. The X-ray source condition will be recommended the tube energy level of 70kVp with variable tube current and exposure time. To acquire at least 2 frames at same condition will be recommended. The median values of bright frames are below.
(Additional 21mm Al filter is recommended for calibration) Point Median Value [LSB 1 500 ~
1000 Table 5 : Median value 2 2900 ~
3400 3 6200~
6700 4 9500 ~
10000 The Purpose of Bright Calibration The center of the non calibrated image is brighter than the edge due to hill effect of X-ray exposure. Generally, the intensity of X-
ray flux at center region of exposed area is higher than surroundings due to the X-ray expose like cone shape. A calibration process is used to compensate for this effect. Generally, called it Flat Field Correction(Bright calibration). 52 R-USM-020
(2) Calibration Describe the calibration step by step. 1st Step Click on the Get Dark button. The acquired dark frame dark.raw will be generated in the \cal\ folder. Figure 5: Get dark R-USM-020 53 Click button [Get Bright]. It will produce frame with name %CAL%
xNNNNNA.raw, where NNNNN is median pixels value within current image borders after offset calibration
(cut frame edges are never used during calibration). Suffix A (it also could be B,C etc) avoids casual coincidence of file names. 2nd Step Push Get Bright button at different four of X-ray condition. The X-ray condition should be set or tested before, same as the level of 1.2. Push Get Bright button at least 2 times at same condition, and is the offset subtracted bright (gain) generated which of filename is xNNNNNA.raw(Refer to NOTE) then Figure 6: Get bright. R-USM-020 54 3rd step After 2nd step, the Generate button will be activated. Click the button Generate, and then calibration point will be generated which of file name is A # of point_ median value of generated point like file of bright frame. The acquired bright frames within tolerance value which is variance of median level of acquired bright frames will be averaged and generated to a calibration point. The tolerance value can be edited. After making calibration point the Generate button will be disabling. Figure 7: Generate R-USM-020 55 4th step After 3rd step, Change Bad Pixels Removal Tab, Click the button Generate Auto BPM, and then Defect Map will be generated which of file name is BPM.raw at the \cal\ folder. Figure 8: Bad pixels removal R-USM-020 56 5th step For additional Defect correction, if BPMM.raw is existed at the install CD, copy to the \cal\ folder. 6th step On Acquisition Tab. Check the box Offset Calibration, Gain Calibration, Bad Pix Map for activate to each calibration and Bad Pixels Removal. Otherwise, it will does not working when going to pre-processing . Figure 9: Application of calibration R-USM-020 57 6. Image Acquisition Test
(1) Get Image On Acquisition tab, click the Get Image button to get image. After click the button, you can see pop-up window, which is display window time and process of acquiring image. 58 R-USM-020
(2) View Images Frame- and image-files have extension raw and contain pixel data in signed 16-bits little-endian format. One could view those files in Photoshop or another image editor. R-USM-020 59 Common controls and displayed statistics Pixel_Min minimum pixel value in frame- or image- data Pixel_Max maximum pixel value Pixel_Black if a pixel Pixel_Black then it is displayed as black (RGB 0, 0, 0) Pixel_White if a pixel Pixel_Black then it is displayed as black (RGB 255, 255, 255) R-USM-020 60 Histograms presentation Relative Histogram Scale [H]=1000 means that that the distance depicted as H on the drawing matches 1% of total number of pixels. Respectively [H]=100 means that H matches 0.1% of pixels and [H]=500 means that H matches 0.5% of pixels. R-USM-020 61 Marker type S Displays local surround of selected location Marker type R Display profile chart of a row. R-USM-020 62 Marker type C Display profile chart of a column. R-USM-020 63
(3) Get Recent Frame If the image is not transferred to the PC after exposure because of connection fail (wire or wireless). You can get a recent frame again. R-USM-020 64 7. Operation
(1) Recommend X-ray detector should be used at stable state within driving temperature range. Acquire the X-ray images after power on and 5 minutes warming up to obtain high quality images. The calibration should be performed every 6 months
(2) Switching power on / off All connection should be done, before turn on the power. Press the power button by more than 3 sec, when power on/off. The green light of the LED indicator on the detector is on, the detector power is on. The blue light of the LED indicator on the detector is blinking, the detector is getting prepared to work and initialize. After power off, separate the battery.
(3) Storage Store the sensor unit in clean and dry place. Ensure that storage place should be not affected by dust or liquids. R-USM-020 65 8. Safety Information Do not touch signal input, signal output or other connectors, and the patient simultaneously. External equipment intended for connection to signal input, signal output or other connectors, shall comply with relevant IEC Standard.
(1) Safety standard This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2:1994. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generate, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, 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 device. Increase the separation between the equipment. Connect the equipment into an outlet on a circuit different from that to which the other devices are connected. Consult the manufacturer or field service technician for help
(e.g., IEC 60950-1 for IT equipment and IEC 60601-1 series for medical electrical equipment.) In addition, all such combination system shall comply with the standard IEC 60601-1 and/or IEC 60601-1 harmonized national standard or the combination. If, in doubt, contact qualified technician or your local representative. R-USM-020 66 Type of protection against electric shock: Class I equipment Classification according to the degree of protection against ingress of water as detailed in the current edition of IEC 529:
IPX0, ordinary equipment This equipment is not suitable for use in the presence of flammable anesthetic s or oxygen. Mode of operation: continuous operation R-USM-020 67
(2) Electromagnetic Compatibility Information Guidance and manufacturers declaration - electromagnetic emissions The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity Test RF Emissions CISPR 11 Compliance Group 1 Electromagnetic Environment - Guidance The EUT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A The EUT is suitable for use in ail establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000-3-2 Complies Voltage fluctuations/
Flicker emissions IEC 61000-3-3 Complies The EUT is suitable for use in ail establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes The EUT is suitable for use in ail establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes R-USM-020 68 Guidance and manufacturers declaration - electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60Hz) magnetic field IEC 61000-4-8 IEC 60601-1-2 Test level 6kV Contact 8kV air Compliance level 6kV Contact 8kV air 2kV for power supply lines 1kV for input/output lines 2kV for power supply lines 1kV for input/output lines 1kV differential 1kV differential 2kV common 2kV common mode mode mode mode
<5% U
(>95% dip in U) for 0.5 cycle 40% U
(60% dip in U ) for 5 cycle 70% U
(30% dip in U) for 25 cycle
<5% U
(<95% dip in U ) for 5 s
<5% U
(>95% dip in U) for 0.5 cycle 40% U
(60% dip in U ) for 5 cycle 70% U
(30% dip in U) for 25 cycle
<5% U
(<95% dip in U ) for 5 s 3 A/m 3 A/m Electromagnetic environment -
guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the EUT image intensifier requires continued operation during power mains interruptions, it is recommended that the EUT image intensifier be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE U is the a.c. mains voltage prior to application of the test level. R-USM-020 69 Guidance and manufacturers declaration - electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Electromagnetic environment - guidance Immunity test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601-1-2 test level 3 Vrms 150 kHz to 80MHz 3 V/m 80 MHz to 2.5GHz Compliance level V1=3Vrms E1=3V/m Portable and mobile RF communications equipment should be used no closer to any part of the EUT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance :
d d d 5.3 V 1 5.3 E 1 7 E 1 P P 80MHz to 800MHz P 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol :
NOTE 1) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EUT. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m. R-USM-020 70 Recommended separation distances between portable and mobile RF communications equipment and the EUT There is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EUT can help Prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the EUT as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter [m]
IEC 60601-1-2 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz d P d P d P 5.3 V 1 V1=3Vrms
(meters) 0.116 0.368 1.166 3.687 11.660 5.3 E 1 E1=3V/m
(meters) 0.1166 0.3687 1.1660 3.6872 11.6600 7 E 1 E1=3V/m
(meters) 0.2333 0.7378 2.3333 7.3785 23.333 Separation Distance Separation Distance Separation Distance Frequency of Transmitter Equation Rated maximum output power of transmitter
[W]
0.01 0.1 1 10 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1) At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EUT. b Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m. Name Link cable P-interface cable USB cable (A to B) AC power cord (220V) Notes Provided with wiring unit. Provided with X-ray interface unit. Provided with AGI unit. Provided with charger unit. Length Shield Type Shielded 6 m Non-shielded 8 m Non-shielded 1.8 m 1.8 m Shielded R-USM-020 71 Immunity and Compliance Level Immunity test IEC 60601-1-2 Test Level Actual Immunity Level Compliance Level Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3Vrms 150kHz to 80MHz 3Vrms 80MHz to 2.5GHz 3Vrms 3V/m 3Vrms 3V/m Guidance and manufacturers declaration - electromagnetic immunity The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an electromagnetic environment. Immunity test Electromagnetic environment - guidance IEC 60601-1-2 Compliance Conducted RF IEC 61000-4-6 Test level 3 Vrms 150kHz to 80MHz level 3 Vrms 150 kHz to 80MHz Radiated RF IEC 61000-4-3 3V/m 80MHz to 2.5GHz 3V/m 80MHz to 2.5GHz The EUT must be used only in a shielded location with a minimum RH shielding effectiveness nad, for each cable that enters the shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location. Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m.a Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength outside the shielded location in which the EUT is used exceeds 3V/m, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation. R-USM-020 72 9. Radio Frequency compliance
(1) FCC Notice (U.S.A) Test standards
- 47CFR Part 15.107 (b) / 47CFR Part 15.109 (g) Class A.
- FCC Part 15 C Section 15.247, Operation within the bands 902928 MHz, 24002483.5 MHz, and 57255850 MHz
- FCC Part 15 C Section 15.407, Operation within the bands 902928 MHz, 24002483.5 MHz, and 57255850 MHz FCC ID: QIIRY1417W 5.15- 5.25 GHz band is restricted to indoor operations only. Host device of the approved module shall be marked with the following item:
Contains Transmitter Module FCC ID: PPD-AR5BHB116 Compliance with FCC requirement 15.407(c) Data transmission is always initiated by software, which is the passed down through the MAC, through the digital and analog baseband, and finally to the RF chip. Several special packets are initiated by the MAC. These are the only ways the digital baseband portion will turn on the RF transmitter, which it then turns off at the end of the packet. Therefore, the transmitter will be on only while one of the aforementioned packets is being this device automatically discontinues transmission in case of either absence of information to transmit or operational failure. In other words, transmitted. 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. R-USM-020 73 FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. When installing it in a mobile equipment This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65. This equipment has very low levels of RF energy that it deemed to comply without maximum permissive exposure evaluation (MPE). But it is desirable that it should be installed and operated keeping the radiator at least 20cm or more away from persons body (excluding extremities: hands, wrists, feet and ankles). When you use the detector with wire mode, the wireless function is automatically off. R-USM-020 74
(2) IC Notice (CANADA) Test standards
- ICES-003 Issue 4
- IC RSS-210 Issue 7, Operation within the bands 902928MHz, 24002483.5 MHz, and 57255850 MHz
- IC RSS-210 Issue 7, Operation within the bands 902928 MHz, 24002483.5 MHz, and 57255850 MHz IC: 10742A-1417W This Class A digital apparatus complies with Canadian ICES-003 Host device of the approved module shall be marked with the following item:
Contains Transmitter Module Radio Certification No. : 4104A-AR5BHB116 This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le present appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisee aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioelectrique subi, meme si le brouillage est susceptible d'en compromettre le fonctionnement. R-USM-020 75
(3) R&TTE Notice (European Union) Test standards
- EN 62311
- ETSI EN 301 489-1
- ETSI EN 301 489-17
- ETSI EN 300 328
- ETSI EN 301 893 R-USM-020 76 10. Maintenance For safety reasons, be sure to turn OFF the power of the detector when the following inspections are going to be performed. Otherwise, it may result in electric shock.
(1) Maintenance Maintenance of the detector should be done by an authorized service provider If the Detector Panel is defective, the detector will be returned as is to the manufacturer for repair Clean the equipment with a dry soft cloth, or a soft cloth lightly moistened with mild detergent solution. Do not use any type of solvent, such as benzene This equipment and accessories are to be disposed of safely after the life span of them and national regulation must be observed. For safety reasons, be sure to inspect the instrument before using it. In addition, carry out a regular inspection at least once a year. Arrange the detector and power supply link cable to prevent the damage of the cables rubber tube. For example, do not press the cable under the legs of the table or the people. This equipment must only be connected to a supply mains with protective earth.
(2) Cleaning Cover When the instrument is going to be cleaned, be sure to turn OFF the power of each instrument, and unplug the power cable from the AC outlet. Otherwise, fire or electric shock may result. Clean the cover by the left warning box, if it is dirty. CFRP of Detector Wipe the CFRP plate of the sensor unit with ethanol or glutaraldehyde solution to disinfect it each time a different patient uses the instrument, in order to prevent infection. If you are using disinfectant other than those specified above, or you are mixing another disinfectant with ethanol, please also consult a specialist, because they may harm the CFRP plate. R-USM-020 77
(3) Inspection In order to ensure that the instrument is used safely and normally, please be sure to inspect the instrument before use. If any problem is found during the inspection, please take measures indicated in this chapter. If problem still cannot be corrected, please contact Rayence representative or distributor. It is recommended that a record of the inspection be kept by making copies of the check lists in this section, or making a separate check list. Inspection chart Inspection User Vendor Cycle Check that cables are not damaged or cover of cables is not torn Check that the plugs and locks of connectors are not loose Check that the cover or parts are not damaged and not loose Check the LED indicator Check the bad pixel map Check the performance of the instrument performing exposures using a phantom or a resolution chart by O O O O O O Daily Daily Daily Daily Half year Yearly R-USM-020 78
(4) Disposal or Recycling Follow local governing ordinances and recycling plans regarding the disposal or recycling of device components. Disposal of old Electrical & Electronic Equipment
(Application in the European Union and other European countries with separate collection system.) This symbol indicates that this product shall not be treated as household waste. Instead, it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment. By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this product. For more detailed information about recycling this product, please refer to local governing ordinances and recycling plans. R-USM-020 79
(5) Marking and labeling symbols Symbols Meaning Caution : Attention, see instructions for use Alternate current Protective earth (Ground) Off (power : disconnect from the main switch) On (power : connect to the main switch) Warning Caution Note Manufacturer Date of manufacture Serial number TYPE B Equipment R-USM-020 80
: Waste Electrical and Electronic WEEE Equipment Authorized representative Community in the European CE symbol grants the product compliance to the European Directive for Medical Devices 93/42/EEC as a class b device and 1999/5/EC. Authorized by Notified Body SGS
(code no.:0120) of British Recognized Component Mark for Canada and the United States non-ionizing radiation For KOREA Korea Certification For JAPAN Product Safety of Electrical Appliance & Materials For JAPAN Telecom Engineering Center (TELEC) :
Technical Regulations Conformity Certification 81 R-USM-020 Appendix Dimension
[unit : mm]
R-USM-020 82 Rayence Co., Ltd. 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea www.rayence.com Rayence Co., Ltd. 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea www.rayence.com R-USM-020 83
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2014-07-24 | 5190 ~ 5230 | NII - Unlicensed National Information Infrastructure TX | Original Equipment |
2 | 5755 ~ 5795 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2014-07-24
|
||||
1 2 | Applicant's complete, legal business name |
Rayence Co., Ltd.
|
||||
1 2 | FCC Registration Number (FRN) |
0022096333
|
||||
1 2 | Physical Address |
14, Samsung 1-ro 1-gil
|
||||
1 2 |
Hwaseong-si, Gyeonggi-do, N/A 18449
|
|||||
1 2 |
South Korea
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
T******@TIMCOENGR.COM
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
QII
|
||||
1 2 | Equipment Product Code |
RY1417W
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
N******** H******
|
||||
1 2 | Title |
Assistant Manager
|
||||
1 2 | Telephone Number |
+82-3********
|
||||
1 2 | Fax Number |
+82-3********
|
||||
1 2 |
n******@rayence.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | 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 | 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 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 09/07/2014 | ||||
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 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | NII - Unlicensed National Information Infrastructure TX | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Medical Image Processing Unit | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | 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 | Grant Comments | Power listed is conducted. This device has 20 and 40MHz bandwidth modes. Operations in the band 5.15-5.25GHz are restricted to indoor use only. SAR compliance for portable use conditions has been evaluated as described in this filing. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter. The highest reported SAR values for head, and body-worn conditions are 0.37W/kg, and 0.34W/kg, respectively. | ||||
1 2 | Power listed is conducted. This device has 20 and 40MHz bandwidth modes. SAR compliance for portable use conditions has been evaluated as described in this filing. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter. The highest reported SAR values for head, and body-worn conditions are 0.30W/kg, and 0.21W/kg, respectively. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | 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 | Firm Name |
KES Co., Ltd
|
||||
1 2 | Name |
I**** R****
|
||||
1 2 | Telephone Number |
82-31********
|
||||
1 2 | Fax Number |
82-31********
|
||||
1 2 |
k******@kes.co.kr
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15E | CC MO | 5180 | 5240 | 0.044 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15E | CC MO | 5190 | 5230 | 0.049 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC MO | 2412 | 2462 | 0.524 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15C | CC MO | 2422 | 2452 | 0.295 | |||||||||||||||||||||||||||||||||||
2 | 3 | 15C | CC MO | 5745 | 5825 | 0.238 | |||||||||||||||||||||||||||||||||||
2 | 4 | 15C | CC MO | 5755 | 5795 | 0.222 |
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