Release Version 1.0.
© Copyright 2012, 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 is prohibited without the express written authorization from Rayence Corporation. Please report any violations of requirement to Rayence Corporation.
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.
Contents Introduction ........................................................................................ 1 Intended use ...................................................................................... 1 Product features ................................................................................ 2 Product components ......................................................................... 3 Components Description................................................................... 5 Warning ..
Introduction Overview The 1417WCA 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. Intended use For U.S.A.
Product features Wi-Fi (802.11a/g/n) Based on a-Si TFT active matrix Compact (15.9mm thickness) and light weight (Typ. 3.6kg) Limiting Resolution : 3.
Product components Photo Medical Image Processing Unit Item Part Name Quantity Detector SD1417WCA 1 Handle - 1 Battery pack RB37WH 2 Battery charger RC120W 1 Charger adapter PMP120-13-3 1 AGI RA001A 1 3 R-M-014-130312
Cables Item Part Name Length Quantity Link cable VRH076A 6m 1 PInterface cable VRH017A 8m 1 USB cable(A to VRH078A B) 1.8m 1 AC Power VRH018A/019A cord 1.
Components Description The detector is designed to capture radiographic images. Captured images are transmitted to PC using the wireless/wired connection. 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. 1417WCA (FCC ID: QIIRY1417WCA) in the RF module (FCC ID: PPD-AR5BHB116) does not use DFS band. The module adopts the latest 802.11n Dual-Band technology (2.4Ghz and 5Ghz).
4. Link cable connector : This is a connector for Wire communication and power supplying. Connect the detector to PC and SMPS(not provided) using Link cable. 5. CFRP(Carbon Fiber Reinforced Plastic) : The part of the patient’s body to which an image is to be taken should be placed against this plate. 6. Power button : Power on / Power off switch. 7. Shock sensor : Detector has built-in 4 Shock sensors. It detects and records impact and mishandling of fragile 8.
(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.. 2. USB connector: This is a connector for communication between AGI and PC. Connect the AGI to the PC using USB cable.
Warning Make sure to observe the following right 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 inside the instruments.
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.
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. Prone to vibration. Insecure place. Dusty environment. Saline or sulfurous environment.
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.
Marking and labeling symbols Symbols Meaning Caution : “Attention, see instructions for use” Manufacturer Date of manufacture Serial number WEEE : Waste Electrical and Electronic Equipment Authorized representative in the European Community CE symbol grants the product compliance to the European Directive for Medical Devices 93/42/EEC as a class Ⅱa device. Authorized by Notified Body SGS (code no.
Labels Detector label Battery label 13 R-M-014-130312
Notes for Using the Detector 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, RC120W is designed for the dedicated battery pack.
Handling Handle the instrument carefully, as it may be damaged if something is hit against it, dropped, or receives a strong jolt. Handle Assembly ※ Insert the handle always in the same direction.
Please confirm lever position. When the handle is locked, the lever should be same position with the right picture. Insert the handle in the same direction If the handle is not locked, the detector can be dropped.
Before Exposure Be sure to check the equipment daily and confirm that it works properly. Sudden heating of the room in cold areas will cause condensation to form on the instrument. In this case, wait until condensation disappears before performing exposure. If the instrument is used with condensation formed on it, problems may occur in the quality of the instrument.
Sleep Mode/Wake up Do not change parameters except “Control e” Control “e” parameter : sleep time - 0 : disabled (default) - 1 : 1 sec - 2 : 2 sec … 600 : 600 sec If you set sleep time, the detector goes to the sleep mode after “N” sec after acquiring image If you want to wake up the detector, Press the power button(less than 1 second) 18 R-M-014-130312
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. 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. Others Be sure to reconnect the cables to the proper connectors. Otherwise, the instrument may malfunction or may be damaged.
Technical Features Mechanical Features Size 450 x 417 x 15.9 mm Weight 3.6 kg (not incl. Handle) Encapsulation Material Mg Window Material Carbon fiber plate with 1.2 mm thickness Electrical Features Detector Sensor Type Amorphous Silicon with TFT (Single Panel) X-ray Converter CsI:Tl Total Pixel Number 2816 × 3328 pixels Active Pixel Area 35.8 cm × 42.3 cm Active Pixel Number 2270 × 3280 pixels Pixel Pitch 127 μm Limiting Resolution Max. 3.
Battery Size 232.5 x 132.8 x 7 mm Weight Typ. 0.3 kg Input 12.5 VDC Output 11.1 VDC Charging time Typ. 2.5 hours Capacity Typ. 3400 mAh The number of times being acquired image 600 images The Battery level can be displayed on the LED status of battery. If the battery level goes down under 25%, please charge the battery Battery level Display 75~100 % 50~75 % 25~50 % 0~25 % Charger Size 267.5 x 100 x 77 mm Weight Typ. 0.86 kg Input 20 VDC Output 11.1 VDC Adapter Size 160 x 76 x 43.
Wireless Spec Standard 802.11a/g/n compliance Peak Rate 300Mbps Frequency 2.4 GHz / 5 GHz Bandwidth 20MHz/40MHz MIMO 2x2 ※ Recommended Maximum operable distance : 7m (From the Access Point) ※ 5.15~5.25 GHz band is restricted to indoor operations only. (for FCC) 5.15~5.350 GHz band is restricted to indoor operations only. (for CE) 5.15~5.350 GHz is indoor use only.
Environmental requirement Storage condition Item Min. Temperature Typ. Max. Unit -20 55 ℃ Humidity 10 80 Pressure 70 106 Note % H.R. kPa 16ms, Shocks (Wrapping condition) 10G 1000times, in (25G) 6directions, non-Driving 10-150Hz, Vibrations (Wrapping condition) 2G 10Sweeps, (10G) 1min/Octave, XYZ axis Operation condition Item Min. Temperature Typ. Max. Unit 5 35 ℃ Humidity 30 75 Pressure 70 106 Note % H.R.
PC Requirements Processor : At least Intel Pentium IV HT with 2.
Installation The Detector is composed of sensitive electronic parts and Portable Imaging processing unit must be installed in a way that enables the user to achieve optimal use 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.
Connection Power Connection A. Connect the battery pack or power cable to the equipment. B. Connect the USB cable from your PC to AGI. ※ Be sure to sure only the dedicated battery pack, RB37WH for 1417WCA. 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.
B. Reception Indicator Link LED flickering Blink Speed : Slow – Low link quality Fast – High link quality C. Checking Link Quality - 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.
Trigger Connection A. Connect the P-interface cable to the generator X-ray Generator Connection Make assurance doubly sure SIGNAL RATING before connection. Connect the P-interface cable between the AGI box and X-ray generator. A.
The window time can be changed.
Exposure Time(*clk) 1333333 is designate to 0.
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 32 R-M-014-130312
Using Web 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 web-browser (Optimized for Chrome/Internet Explorer) C. Connect to “http://[Detector’s IP]“ D.
E. Click “SUBMIT” 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 web-browser (Optimized for Chrome/Internet Explorer) C. Connect to “http://[Detector’s IP]“ D.
E. Type Pre-Shared Key to set (Password) (This value should match to Router’s setting Default:project302 ) F. Click “SUBMIT” G. Restart detector(Turn Off then On) Upgrade Firmware A.
B. After detector boot up, Launch web-browser (Optimized for Chrome/Internet Explorer) C. Connect to “http://[Detector’s IP]“ D. Select firmware file by click “Choose File” button. (Released file is named ‘fw_ppc’) E. Click ‘Upload File’ button F. Click ‘Flash Write’ button G.
Calibration General Principle 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. Notation Calibration can be done by image acquisition S/W. The gainoffset correction (under calibration) will be done with one dark, at least one bright and object frame.
Bright Calibration Point 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 ‘20000’ in this case the level is contained in Bright point of ‘4’(refer ‘Table 5 : Median value’). The meaning is you don’t have to make bright point for ‘5’ and ‘6’(In this case, it will be does not working if you get image on higher level than maximum bright point.
Calibration Describe the calibration step by step. 1st Step Move to “Calibration” tap, and push “Get Dark” button. Acquire dark frame, the “dark.raw” will be generated at “\cal\” folder.
Click button [Get Bright]. It will produce frame with name %CAL% xNNNNNA.raw, where NNNNN is median pixel’s 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 six of X-ray condition. The Xray condition should be set or tested before, same as the level of ‘1.2’.
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.
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.
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”, and “Bad Pix Map” for activate to each calibration and Bad Pixels Removal. Otherwise, it will does not working when going to pre-processing .
Image Acquisition Test Program setup To acquire images, run _vadav.lnk program. Please set the following figures Detector’s IP : 2.2.2.
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.
View Images Frame- and image-files have extension “raw” and contain pixel data in signed 14-bits little-endian format. One could view those files in Photoshop or another image editor.
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) 47 R-M-014-130312
Histogram’s presentation Relative Histogram Scale [H]=1000 means 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.
Marker type “S” Displays local surround of selected location Marker type “R” Display profile chart of a row.
Marker type “C” Display profile chart of a column.
Operation 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. 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.
Information Safety standard 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. 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.
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.
Electromagnetic Compatibility Information Guidance and manufacturer’s 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.
Guidance and manufacturer’s 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.
Guidance and manufacturer’s 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.
Recommended separation distances communications equipment and the EUT between portable and mobile RF 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.
Immunity and Compliance Level Immunity test IEC 60601-1-2 Test Level Actual Immunity Level Compliance Level Conducted RF IEC 61000-4-6 3Vrms 150kHz to 80MHz 3Vrms 3Vrms Radiated RF IEC 61000-4-3 3Vrms 80MHz to 2.5GHz 3V/m 3V/m Guidance and manufacturer’s 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.
Radio Frequency compliance FCC/IC Notice (U.S.A and CANADA) FCC Part 15 Subpart C §15.247 and IC RSS-210 Issue 7 FCC Part 15 Subpart E §15.407 and IC RSS-210 Issue 7 FCC ID: QIIRY1417WCA 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.
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 person’s body (excluding extremities: hands, wrists, feet and ankles). When you use the detector with wire mode, the wireless function is automatically off.
Maintenance 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.
Inspection 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. 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.
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.
Appendix Dimension [unit : mm] 64 R-M-014-130312
Medical Image Processing Unit 1417WCA Rayence Co., Ltd. 14, Samsung 1ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea www.rayence.
