Rayence RY1012WA Medical Image Processing Unit User Manual

Rayence Co., Ltd. Medical Image Processing Unit Users Manual

Contents

Users Manual

         1012WCA User manual
                          ©  Copyright 2013, 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. 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.       This is used to emphasize essential information. Be sure to read this information to avoid incorrect operation.   This indicates a potentially hazardous situation which, if not heeded, could result in death or serious injury to you or others.   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. 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.
       Contents 1. Introduction .................................................................................... 1 (1) Overview ........................................................................................ 1 (2) Intended use .................................................................................. 1 (3) Product features ........................................................................... 2 (4) Product components .................................................................... 3 (5) Components Description ............................................................. 5 (6) Warning ........................................................................................ 10 (7) Caution ........................................................................................ 12 2. Notes for Using the Detector ...................................................... 15 (1) Preparing ..................................................................................... 15 (2) Handling ...................................................................................... 16 (3) Handle Assembly ........................................................................ 16 (4) Before Exposure ......................................................................... 17 (5) During Exposure ......................................................................... 18 (6) Limit of Load ............................................................................... 19 (7) Disinfection and Cleaning ......................................................... 20 (8) Others .......................................................................................... 20 3. Technical Features ...................................................................... 21 (1) Mechanical Features .................................................................. 21 (2) Electrical Features ...................................................................... 21 (3) Environmental requirement ....................................................... 24 (4) PC Requirements ........................................................................ 24 4. Installation ................................................................................... 25 (1) Program setup ............................................................................ 25 (2) Connection (Manual Trigger) ..................................................... 26 (3) Connection (Auto Trigger) ......................................................... 34 (5) IP set up ....................................................................................... 39 (6) Using FPD_Manager (IP, SSID Change / Upgrade FW) ........... 40 5. Calibration .................................................................................... 49 (1) General Principle ........................................................................ 49 (2) Calibration (Manual mode) ........................................................ 51 (3) Calibration (Auto mode) ............................................................. 57 6. Image Acquisition Test ................................................................ 62 (1) Get Image .................................................................................... 62 (2) View Images ................................................................................ 63 (3) Get Recent Frame ....................................................................... 68 7. Operation ...................................................................................... 69 (1) Recommend ................................................................................ 69 (2) Switching power on / off ............................................................ 69 (3) Storage ........................................................................................ 69 8. Safety Information ....................................................................... 70 (1) Safety standard ........................................................................... 70 (2) Electromagnetic Compatibility Information ............................. 72 9. Radio Frequency compliance ...................................................... 77 (1) FCC Notice (U.S.A) ..................................................................... 77 (2) IC Notice (CANADA) ................................................................... 79 (3) R&TTE Notice (European Union) .............................................. 80
       10. Maintenance ................................................................................. 81 (1) Maintenance ................................................................................ 81 (2) Cleaning ....................................................................................... 81 (3) Inspection .................................................................................... 82 (4) Disposal or Recycling ................................................................ 83 (5) Marking and labeling symbols .................................................. 84 Appendix .............................................................................................. 86
1  1. Introduction  (1) Overview The 1012WCA 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.  It  is  intended  to  replace  film  or  screen  based radiographic  systems  in  all  general  purpose  diagnostic procedures. Not to be used for mammography.
2  (3) Product features                Wi-Fi (802.11a/g/n)   Based on  a-Si TFT active matrix   Compact and light weight    Limiting Resolution    14/16-bit digital output   Easy integration
3  (4) Product components   Medical Image Processing Unit Photo Item Quantity  Detector 1 Handle 1       Battery pack 2 Battery charger 1        Charger adapter 1     AGI 1
4     Cables  Item Length Quantity       Link cable 7m 1  P-Interface cable 8m 1    USB cable(A  to B) 1.8m 1  LAN cable 10m 1     AC  Power cord 1.8m 2      Trigger cable 3m 1    Installation CD o  Manual o  Detector Library
5  (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.  Link Cable Connector : Use for charging battery while detector is in use(Connect between detector and power supply)  2.  LED indicator: Indicating the state of detector.
6  3.  Power & Mode Sleep Button    4.  Handle unlock-lever : This is an unlock-lever to remove handle.  5.  Handle  :  Hold  this  handle  when  carrying  the  sensor  unit.  It  is removable. (Horizon/Vertical)  6.  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.   7.  Shock  sensor  :  Detector  has  built-in 2 Shock sensors. It detects and records impact and mishandling of fragile  8.  Battery unlock-lever : This is an unlock-lever to remove battery.  9.  Battery : Lithium ion battery.
7  (2) Battery & Charger           1.  Battery : Rechargeable Lithium Ion battery(Charging Time-3 hrs) ※ In the diagram above, the box shows where the remaining battery percentage is displayed.  2.  Battery Charger : Two port cradle type.  3.  LED indicator : Displays battery charging status
8   ※Wireless Module and Wireless Antenna  Wireless antennas: The module adopts the latest 802.11n Dual-Band technology. DUT does not support simultaneous transmission. The transmitter of the module is powered by host equipment (Detector). The antennas are 2 printed-dipole and correlated antennas. Does not support beamforming.   ※Wireless module: The end product will use the in original certified transmitter module and will keep the original authorization condition except the change in antenna of the module during the final end product assembly.     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 transmitted. In other words, this device automatically discontinues transmission in case of either absence of information to transmit or operational failure. 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. FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s 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 person’s body (excluding extremities: hands, wrists, feet and ankles). When you use the detector with wire mode, the wireless function is automatically off. ※5150~5250 MHz band is restricted to indoor operations only.
9  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.  Operations to just the specific band(s) : limited device Software program. User cannot enable the other bands, because PC set up should be necessary. (details for user manual_Ch.3 Installation and Calibration)
10   (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  inside  the  instruments.  Also,  some disinfectants  are  flammable.  Be  sure  to  take  care  when  using them. 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 Router’s 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.                                  Make sure                  to observe the following right
11  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.
12  (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.   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 patient’s vicinity.
13  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  the  party  responsible  for compliance  could  void  the  user's  authority  to  operate  the equipment. Battery Do  not  let  the  detector  or  battery  come  in  contact  with liquids.  Liquids  can  get  into  the  detector’s  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.
14  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
15  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,  RC120W  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. Slide the lock lever toward (lock) side and lock it.
16  (2) Handling          Handle  the  instrument  carefully,  as  it  may  be  damaged  if something is hit against it, dropped, or receives a strong jolt.  (3) Handle Assembly            ※ Insert the handle always in the same direction. A B
17    Handle Assembly Type 1                    Handle Assembly Type 2  (4) 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.    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 Insert the handle in the same direction A                                  If the  handle is  not locked, the detector can be dropped. Please confirm lever position. When the handle is locked, the lever should be same position with the right picture.
18  room and in the instrument does not occur, to prevent forming of condensation.  (5) 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.
19  (6) 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.
20    Be sure to use the sensor unit on a flat place so it will not bend. Otherwise, the sensor may be damaged.  (7) 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.  (8) Others Be  sure  to  reconnect  the  cables  to  the  proper  connectors. Otherwise, the instrument may malfunction or may be damaged.
21  3. Technical Features (1) Mechanical Features Size 395 x 337 x 18 mm Weight 2.7 kg (not incl. Handle) Encapsulation Material Mg Window Material Carbon fiber plate with 1.5mm thickness  (2) Electrical Features Detector Sensor Type Amorphous Silicon with TFT (Single Panel) X-ray Converter CsI:Tl Total Pixel Number 2560 × 2048 pixels Total Pixel Area 325 x 260 mm Effective Pixel Number 2520 × 2008 pixels Effective Pixel Area 320 x 255 mm Pixel Pitch 127 μm Limiting Resolution Max. 3.9 lp/mm Energy Range 40 - 150 kV A/D Conversion 14/16 bits Preview Time < 2.0 sec (wired) < 5.0 sec (wireless) Data Interface - Wireless - Wired  Wi-Fi (802.11a/g/n) Gigabit Ethernet   Under RQA5 condition (70kVp, 21mmAl)   Preview time is not included post-processing time  Battery Size 232.2 x 130.9 x 7 mm Weight Typ. 0.3 kg Input 12.6 VDC Output 11.1 VDC Charging time Typ. 2.5 hours
22  Capacity Typ. 3400 mAh The number of times being acquired image 1060 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 %  Charger Size 267.5 x 100 x 77 mm Weight Typ. 0.7 kg Input 20 VDC Output 12.6 VDC  Adapter Size 160 x 76 x 43.7mm (cable length: 1.28m) Weight Typ. 0.8 kg  Input 100~240 VAC, 47~63 Hz, 1.4~0.6A Output 20 VDC, Max 6.0A
23  Wireless Spec Standard 802.11a/g/n compliance Without DFS (5.25GH to 5.35GHz and 5.47 to 5.725) Band Peak Rate 300Mbps Frequency 2.4 GHz / 5 GHz Bandwidth 20MHz/40MHz MIMO 2x2   ※  Maximum  wireless  signal  rate  derived  from  IEEE  standard  specifications. Actual  data  throughput  will  Network  conditions  and  environmental  factors, including volume of network traffic, building materials and construction, and network overhead, lower actual data throughput rate. ※Recommended Maximum operable distance : 10m (From the Access Point)  ※Wireless Module and Wireless Antenna ※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: 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.1012WCA  in  the  RF module does not use DFS band.
24  (3) Environmental requirement Item Min. Typ. Max. Unit Note Temperature (Storage) -10  50 ℃  Temperature (Operation) 5  40 ℃  Humidity (Storage) 10  80 % H.R.  Humidity (Operation) 30  75 % H.R.  Vibrations (Wrapping condition)  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.
25  4. Installation  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    Detector’s IP : Wireless - 2.2.2.100  Wired – 2.2.2.101   Detector’s size of image : 2560x2048   Figure 1: Setup                    Portable                  Imaging                 processing unit must be installed in a way that enables the user to achieve optimal use
26  (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. *  When  you  use  the  detector  with  wired  mode,  the  WLAN function is automatically off. B. Connect the USB cable from your PC to AGI. ※ Be sure to sure only the dedicated battery pack, RB37WH for 1012WCA.
27       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
28       C. Checking Link Quality & Battery Remain - After wireless connection is established, perform ‘Get Image’ in ‘Calibration & Acquisition’ 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
29       Software Setting (manual trigger)     Figure 2: Davinci Setting
30       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.        Operating description  Make assurance doubly sure   SIGNAL RATING before connection.
31         The window time can be changed. Refer to the following pictures                    Exposure                 Time                 500msec is designate to 0.5sec
32       B. Mode 2 : Trigger cable mode Connect the Trigger cable between the X-ray enable connector of AGI with X-ray generator.         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 Red Input READY IN Ready Input Signal Black Input READY DONE READY DONE Exposure Output SW1 Green Output READY DONE COM Exposure Output SW2 Blue Output Table 3 : Connection description    Make assurance doubly sure   SIGNAL RATING before connection. AGI Box
33       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                 500msec  is designate to 0.5sec
34       (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 1012WCA.
35       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
36       C. Checking Link Quality & Battery Remain - After wireless connection is established, perform ‘Get Image’ in ‘Calibration & Acquisition’ 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
37       Software Setting (Auto trigger)     Figure 4: Davinci Setting
38       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 won’t acquire images in WAIT mode although X-ray exposure applies. WAIT mode switches back to READY mode after 2-3 seconds. If you don’t want to use ANTI-SHOCK FUNCTION, please click OPTION  IF you don’t 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.
39       (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
40        (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
41       C. Check the “IP Change” and  type current IP address as below  D. Type IP address to set
42       E. Click “Start Setting” button  F. Click “예 (Y) ” button  G. Click “확인” button  H. Restart detector(Turn Off then On)
43       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
44       C. Check the “SSID change” and write current IP address as below  D. Type SSID and PSK to set
45       E. Click “Start Setting” button  I. Click “예 (Y) ” button  F. Click “확인” button  G. Restart detector(Turn Off then On)
46       Upgrade Firmware A. Turn on Detector and connect to PC (wired connection is recommended) B. After detector boot up, Launch FPD_Manager.exe
47       C. Check the “SSID change” and write current IP address as below  D. Select firmware or FPGA file by click “select” button .
48       E. Click “Start Setting” button  F. Click “예 (Y) ” button  G. Click “확인” button  H. Restart detector(Turn Off then On)
49       5. Calibration  (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 Dark image, acquired image without X-ray exposure Bright Acquired image with X-ray exposure Object Bright image with object, will be calibrated Gain Gain of imaging system, offset subtracted image Offset correction Offset subtract Gain correction Compensate gain variance of pixel                 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.
50       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)    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).   Point 1 2 3 4 Median Value [LSB 500 ~ 1000 2900 ~ 3400 6200~ 6700 9500 ~ 10000 Table 5 : Median value                 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 don’t 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.)
51       (2) Calibration (Manual mode) Describe the calibration step by step. 1st Step A. Push “Calibration” button  B. Push “Manual Mode” button
52       C. Click on the “Calibration” button. The acquired dark frame “dark.raw” will be generated in the “\cal\” folder.   Figure 1: Get dark
53       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  then  the  offset  subtracted  bright  (gain)  is generated which of filename is “xNNNNNA.raw(Refer to NOTE)  Figure 2: Get bright.                    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.
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.  Figure  3: Generate   After making calibration point the “Generate” button will be disabling.
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  4: Bad pixels removal
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 5: Application of calibration
57       (3) Calibration (Auto mode) Describe the calibration step by step. 1st Step A. Push “Calibration” button  Figure 1: Calibration
58       B. Click “Start” button to acquire a dark frame then “dark.raw” will be generated in the “\cal\” folder.   Figure 2: Auto calibration start C. When after the dark frame is acquired the pop up will be comes up as ‘figure 3’   Figure 3: Bright acquisition
59       D.   When ‘Bright acquiring bright frame’ is shown, Exposure X-ray to create  Bright points as RED box on ‘Figure 4’ Suitability of the acquired bright frames are shown at the message box as ‘figure 5’, please check the message box for each steps. If calibration is successful, the pop up will appeared as ‘figure 6’  Figure 4: Bright median value    bright point made by average value of 4 bright frames in same condition, therefore, 16frames will be needed to make 4 bright points
60        Figure 5 Bright acquisition message     Figure 6  Calibration complete
61       2nd step For additional Defect correction, if  “BPMM.raw” is existed at the install CD, copy to the “\cal\” folder. 3rd 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 7: Application of calibration
62       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.
63       (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.
64       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)
65       Histogram’s 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.
66       Marker type “S” Displays local surround of selected location  Marker type “R” Display profile chart of a row.
67       Marker type “C” Display profile chart of a column.
68       (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.  .
69       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.
70       8. Safety Information  (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.                    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.
71         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
72       (2) 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  Compliance    Electromagnetic Environment - Guidance  RF Emissions  CISPR 11  Group 1  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 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  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
73       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.  Immunity test  IEC 60601-1-2  Test level  Compliance level Electromagnetic environment -guidance  Electrostatic discharge (ESD) IEC 61000-4-2 ±6kV Contact ±8kV air ±6kV Contact ±8kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.  Electrical fast transient/burst IEC 61000-4-4 ±2kV for power supply lines ± 1kV for input/output lines ±2kV for power supply lines ± 1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment.  Surge IEC 61000-4-5 ±1kV differential mode ±2kV common mode ±1kV differential mode ±2kV common mode Mains power quality should be that of a typical commercial or hospital environment.  Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% Uт  (>95% dip in Uт)  for 0.5 cycle  40% Uт  (60% dip in Uт )  for 5 cycle  70% Uт  (30% dip in Uт)  for 25 cycle  <5% Uт  (<95% dip in Uт ) for 5 s  <5% Uт  (>95% dip in Uт)  for 0.5 cycle  40% Uт  (60% dip in Uт )  for 5 cycle  70% Uт  (30% dip in Uт)  for 25 cycle  <5% Uт  (<95% dip in Uт ) for 5 s  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 (50/60Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.  NOTE Uт is the a.c. mains voltage prior to application of the test level.
74       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.   Immunity test  IEC 60601-1-2  test level  Compliance  level  Electromagnetic environment - guidance        Conducted RF  IEC 61000-4-6    Radiated RF  IEC 61000-4-3         3 Vrms  150 kHz to 80MHz   3 V/m  80  MHz  to 2.5GHz          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 : PVd15.3 PEd15.3 80MHz to 800MHz PEd17 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.
75        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 Frequency of Transmitter  Equation   Rated maximum output power of transmitter [W] 150kHz to 80MHz   PVd15.3   V1=3Vrms  Separation Distance (meters) 80MHz to 800MHz   PEd15.3   E1=3V/m  Separation Distance (meters) 800MHz to 2.5GHz  PEd17   E1=3V/m  Separation Distance (meters) 0.01  0.116  0.1166  0.2333  0.1  0.368  0.3687  0.7378 1  1.166  1.1660  2.3333 10  3.687  3.6872  7.3785 100  11.660  11.6600  23.333 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 Shield Type Length Notes Link cable Shielded 6 m Provided with wiring unit. P-interface cable Non-shielded 8 m Provided with X-ray interface unit. USB cable (A to B) Non-shielded 1.8 m Provided with AGI unit. AC power cord (220V) Shielded 1.8 m Provided with charger unit.
76          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.  Immunity test IEC 60601-1-2 Test level Compliance level Electromagnetic environment - guidance Conducted RF IEC 61000-4-6     Radiated RF IEC 61000-4-3 3 Vrms 150kHz to 80MHz    3V/m 80MHz to 2.5GHz 3 Vrms 150 kHz to 80MHz    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.
77       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    902–928 MHz, 2400–2483.5 MHz, and 5725–5850 MHz - FCC Part 15 C Section 15.407, Operation within the bands    902–928 MHz, 2400–2483.5 MHz, and 5725–5850 MHz   FCC ID: QIIRY1012WCA 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:  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  transmitted.  In  other  words,  this  device  automatically discontinues  transmission  in  case  of  either  absence  of  information  to transmit or operational failure. 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.
78       FCC CAUTION Changes  or  modifications  not  expressly  approved  by  the  party responsible for compliance could void the user’s 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 person’s body (excluding extremities: hands, wrists, feet and ankles).   When  you  use  the  detector  with  wire  mode,  the  wireless  function  is automatically off.
79       (2) IC Notice (CANADA)  Test standards - ICES-003 Issue 4 - IC RSS-210 Issue 7, Operation within the bands    902–928MHz, 2400–2483.5 MHz, and 5725–5850 MHz - IC RSS-210 Issue 7, Operation within the bands 902–928 MHz,   2400–2483.5 MHz, and 5725–5850 MHz   IC: 10742A-1012WCA This Class A digital apparatus complies with Canadian ICES-003  Host device of the approved module shall be marked with the following item:  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.
80       (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
81       10. Maintenance (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 cable’s 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 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.                  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.                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.
82       (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 O  Daily Check  that  the  plugs  and  locks of connectors are not loose O  Daily Check  that  the  cover  or  parts are not damaged and not loose O  Daily Check the LED indicator O  Daily Check the bad pixel map  O Half year Check  the  performance  of  the instrument  by  performing exposures using a phantom or a resolution chart  O Yearly
83       (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.
84       (5) Marking and labeling symbols Symbols Meaning  Refer to instruction manual/ booklet  Alternate current  Protective earth (Ground)  Off (power : disconnect from the main switch)  On (power : connect to the main switch)  Warning  Caution  Read carefully  Manufacturer  Date of manufacture  Serial number
85        non-ionizing radiation   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.:0120) of British  Recognized  Component  Mark  for  Canada  and the United States  CE symbol for wireless  For KOREA Korea Certification  For JAPAN Product Safety of Electrical Appliance & Materials  For JAPAN Telecom Engineering Center (TELEC) : Technical Regulations Conformity Certification
86       Appendix Dimension                 [unit : mm]
87         Rayence Co., Ltd. 14, Samsung 1-ro 1-gil,  Hwaseong-si, Gyeonggi-do, Korea www.rayence.com

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