KTR Radisen PEDRA-1417M User Manual
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KTR Radisen PEDRA-1417M User Manual

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Doc. Name: PEDRA User's Manual/Doc. No.: PEDRA-1417M-UM
Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)
PEDRA-1417M Detector (Wired & Wireless)
"More than just Digital"
Page 1 of 81

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  • Page 1 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) User’s Manual PEDRA-1417M Detector (Wired & Wireless) Before using this equipment, be sure to read this user’s manual thoroughly. Keep this user manual where it is easily accessible. “More than just Digital”...
  • Page 2 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) To customers Thank you for purchasing a PEDRA detector. This User Manual explains how to use the detector, X-ray interface unit, and other peripheral equipment. Before using this product, be sure to read this manual thoroughly in order to utilize it more effectively.
  • Page 3 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Note on installation Request your sales representative or distributor to install this product. Notes on disposal of this product Disposal of this product in an unlawful manner may have a negative impact on human health and the environment.

  • Page 4: Table Of Contents

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Content Safety and Regulatory...............................7 Safety Notices ...................................7 Regulatory ...................................7 Safety Information..............................8 Safety precautions ..............................8 Symbols and detail of marking ........................ 12 Notes for using the equipment........................ 12 Introduction................................
  • Page 5 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Turn on the detector............................36 Detector status list ................... 36 Turn on the Battery Charger........................37 Detector Operation S/W Setting (PEDRA-DMS) ................. 38 Installation................................38 PEDRA Detector Manager ...........................
  • Page 6 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Appendix.3 Specifications ............................61 PEDRA-1417M Specifications ........................61 PEDRA-17F Dimensional diagram ......................62 PEDRA-PCON ..............................63 Battery Pack ................................ 64 Battery Charger ..............................65 Appendix.4 Label and Symbols..........................66 Detector.................................

  • Page 7: Safety And Regulatory

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Safety and Regulatory Safety Notices The following safety notices are used to emphasize certain safety instructions. Follow the safety instructions in this manual along with warnings and cautions symbols. Ignoring such warnings or cautions while handling the product may results in serious injury or accident.

  • Page 8: Safety Information

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 1 Safety Information Safety precautions This product is designed and manufactured to ensure maximum safety of operation and to meet all the safety requirements applicable to electronic medical equipment. Follow these safeguards and properly use the equipment to prevent injury or damage to any equipment or data.
  • Page 9 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)  Do not connect a multiple portable socket-outlet or extension cord to the system. Doing so may result in a fire or electric shock. Warning Handling ...
  • Page 10 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Warning Installation and environment of use  Before authorizing any person to operate the system, verify that the person has read and fully un- derstood the User Manual. The owner should make certain that only properly trained and fully qualified personnel are authorized to operate the equipment.
  • Page 11 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)  Do not spill liquid or chemicals onto the detector. In cases where the patient is injured, do not allow it to come in contact with blood or other body fluids. Doing so may result in a fire or electric shock.

  • Page 12: Symbols And Detail Of Marking

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Symbols and detail of marking Symbol Description Direct Current Alternating Current This mark indicates that this equipment must be handled with care. Do not jolt or apply excessive load to the equipment. General warning sign Attention, consult accompanying documents Read and understand all instructions and warning labels in the product documen-...
  • Page 13 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) When using the device, take the following precautions. Otherwise, problems may occur and the device may not function correctly. Image Backup To avoid missing images which might result in the patient being exposed to additional doses of ra- diation, it is important to backup images by filming or using a CD or DVD option.
  • Page 14 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)  After using the detector and its peripheral device for examination, wipe the patient contact surfaces of the detector and peripheral device (attached handle included), by disinfectants such as IPA and ethanol to prevent infection.
  • Page 15 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)  The device is mainly for use in X-ray exposure rooms and hospital wards. To use it in other places, consult our sales representative or a distributor. ...
  • Page 16 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Detector & Power Supply for wireless communication) Do not expose this device to high temperatures and/or high humidity. Malfunctions may occur.   When not in use, keep the detector, handle unit, and grid in a designated location or in a location where they are safe and cannot fall down.
  • Page 17 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) “More than just Digital” Page 17 of 81...

  • Page 18: Introduction

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2 Introduction PEDRA 1417M detector is a digital X-ray flat panel detector which has 35 ㎝ x 43 ㎝ imaging area and com- municates with wired and wifi communication feature, Giga-bit Ethernet communication method through connecting a tether cable and wifi router.

  • Page 19: Detector Description

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2.3 Detector Description The detector is designed to capture radiographic images. Captured images are transmitted to the viewer computer through a wired and wireless con- nection.
  • Page 20 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) C. Tether port: Allows the detector to communicate with the Power Supply via tether cabling (Gigabit Ethernet)1000 BASE-T). D. Wifi Antenna E. Battery Connector (1) Battery connection parts (2) AP mode On/Off button: User can select AP mode or Wifi (or tether) mode.

  • Page 21: Power & Control Box (Pedra-Pcon) Description

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2.4 Power & Control Box (PEDRA-PCON) Description PEDRA-PCON is connected in between PEDRA detector and work station computer. This device supplies DC power to PEDRA detector, and receives orders from the computer. And it transmits digital images from PEDRA detector to the station.
  • Page 22 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) (5) X-ray SYNC port: READY/EXPOSURE out port Operation: When an event occurs in normal open condition, RDY_OUT/EXP_OUT and RDY_COM/EXP_COM are closed. (6) Status lamps: PCON Power LED: Power on LED (Blue) b.

  • Page 23: Battery Charger (Pedra-Bc001) Description

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2.5 Battery Charger (PEDRA-BC001) Description (1) Power input port: Supplies electric power by connecting a power adapter to the battery charger. (2) Power LED: Indicates the power status On / Off (3) Charging Status LED: Indicates charging status of a battery pack.

  • Page 24: Components

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2.7 Components PEDRA consists of Detector, PEDRA-PCON, Generator SYNC, Tether Cables and some accessories. PEDRA-17F PEDRA-PCON AC/DC Adapter Tether Cable AC Power Cable (230V & 120V) LAN Cable Generator SYNC Cable (Option) “More than just Digital”...
  • Page 25 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Battery Charger Battery Adapter Battery AC Power Cable (230V & 120V) 1) Standard Part: Item Product Name PEDRA-1417M (scintillator: CsI (TI)): 3.0kg Detector (GdOS): 3.20kg Power &...

  • Page 26: Workstation (Recommended)

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2) Optional Part Item Product Name Hand Switch SYNC cable Hand Switch Handle Portable used Handle Manual Mode use USB Cable Caution The use of accessories and cables other than those specified, with the exception of PEDRA accessories and cables sold by Manufacturer.

  • Page 27: Grid (Recommended Not Included)

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2.9 Grid (Recommended not included) Item Description 100 /130/150/180 cm Size 384mm x 460mm x 1.5mm Ratio 10 : 1 Frequency 200 Line/inch Inter spacer “More than just Digital”...

  • Page 28: Detector Installation

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3 Detector Installation PEDRA_1417M detector is properly adjusted at installation by a service engineer. If you encounter any problems during normal operation or daily inspections, consult your sales representative or distrib- utor.
  • Page 29 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Make sure that the battery pack is securely attached. The remaining battery charge can be checked on the monitor of viewer.  You can use the detector while charging the battery by connecting tether interface. Charging Source Charging Time Charging (quantity)
  • Page 30 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) When the detector is not to be used for some time, remove the battery pack. Otherwise, over discharge may occur resulting in the shortened battery life. You can purchase an optional battery pack to replace an exhausted one.

  • Page 31: Connection

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.2 Connection 3.2.1 Tether Connection The PEDRA 1417M detector and Power box are connected with the tether cable. PEDRA 1417M detector has a tether interface cable. With the wiring connector, it is possible to switch from a wireless configuration to a wired configuration (see the figure).

  • Page 32: Wireless Connection

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.2.2 Wireless Connection Wireless Connection mode is the wireless connection method that connecting the detector with wifi router as the center wirelessly. The PEDRA 1417M detector and Router are connected wirelessly. In this case, Router and Detector operate as AP (Access Point) and Station respectively.

  • Page 33: Detector Ap Connection

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.2.3 Detector AP Connection Detector AP mode is the wireless connection method that connecting the PC (Workstation) with the detector as the center wirelessly. The PEDRA 1417M detector and PC are connected wirelessly. In this case, the detector and the PC operate as AP (Access Point) and STATION respectively.

  • Page 34: Pedra-Pcon Connection

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.3 PEDRA-PCON Connection 1) To transmit image data and generator signal using a tether cable, connect the one end of the tether cable to the PEDRA-PCON and the other to the detector. 2) Connect the one end of the LAN cable to the PEDRA-PCON, and the other to the LAN Card Connector of workstation assigned for the Data Transfer.
  • Page 35 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Lamp type [only for wired connection] PCON Power X-ray Exposure Detector Power Color Blue Orange Green PCON Power ON b. X-ray ready & Shot Detector Power ON PCON Power OFF Lights on X: Lights off “More than just Digital”...

  • Page 36: Turn On The Detector

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.4 Turn on the detector Detector status list : Press the power button of the detector for 1.0 second, then the green LED is activated. And detector of Green LED is activated after 40 seconds of blinking every 0.5 seconds.

  • Page 37: Turn On The Battery Charger

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.5 Turn on the Battery Charger 1) Connector for Power adapter is positioned on left side of charger. Description Power lamp Function DC Input power (Blue) 15Vdc 4A(Max) Status LED (Green) Charging is on going...

  • Page 38: Detector Operation S/W Setting (Pedra-Dms)

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 4 Detector Operation S/W Setting (PEDRA-DMS) Allow the detector for at least 30 minutes to warm up before use for maximum performance. Otherwise, it may result in faulty images until warm up has oc- curred.
  • Page 39 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) (1) Path setting User can set work folder. “More than just Digital” Page 39 of 81...
  • Page 40 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Calibration, image, log folders are automatically created in the set work folder. Calibration files are saved in the calibration folder. (dark, bright, BPM) The exposured image is saved in the image folder. Logs are saved in the log folder.
  • Page 41 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) ○ 2 Detector Parameter - Detector resolution & bit - Use AED or Manual mde (image can be acquired to Hand Switch connection with PEDRA-PCON) - image rotate by CW +90 - Detector advanced setting (do not set in normal user) : Get Detector parameter from Detector...
  • Page 42 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) - Sets effective area of an image. (3) Detector status check User can check dectector status (detector temp., wifi strength, battery level) : User can check Detector status : User can check Detector log : User can check Detector status check data (4) Get image for calibration...
  • Page 43 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) ○ 1 Image list - saved image list from dark & bright files ○ 2 Selected Dark files - Dark files, selected from the dark files acquired by the user for calibration. User can select up to five for calibration.
  • Page 44 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) ○ 1 Load BPM & Save BPM - Load the BPM file that needs to be modified, or save the modified file. ○ 2 image tools - User can adjust zoom ○...

  • Page 45: Calibration Procedure

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) (7) Log & Image view User can check the PEDRACalib’s log. (Click once more to disappear.) : User can check the dark or bright image. (Click once more to disappear.) : Exit the PEDRACalib.
  • Page 46 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Step 0. Connect detector Input detector IP & port then Connect. Step 1. Selection of AED mode: For more detail information, refer to AED mode configuration, chapter, 5.2. Step 2.
  • Page 47 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Step 3. After Step3, Click the “ ” button The X-ray condition should be set or tested beforehand, Click the “Get Bright” (The acquired Bright frame “Bright_ image resolution_bit_bright value.raw”...
  • Page 48 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Step 5. Getting raw image: Select the AED or Manual mode and shoot the X-ray using the “Hand switch or shoot button on the X-ray Generator. The way of the image acquiring is referenced to AED or Manual mode operating, chapter 5.2 and 5.3.

  • Page 49: Operation

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 5 Operation 5.1 Wireless Standard Configuration and Operation Generally, the PEDRA detector is used in a wireless configuration as illustrated below: Wireless communication is established between the PEDRA detector and Router. The PEDRA detector is compliant with IEEE 802.11 a/b/g/n (2.4 ㎓...

  • Page 50: Aed Mode Configuration And Operation In Wired Mode

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 5.2 AED Mode Configuration and Operation in wired mode AED mode is available for acquiring images without any connection to the X-ray generator with an X-ray SYNC cable The way of image acquiring is as follows;...

  • Page 51: Manual Mode Configuration And Operation In Wired Mode

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 5.3 Manual Mode Configuration and Operation in wired mode Hand switch is connected with the PEDRA-PCON to communicate with the PC via USB cable. Manual Mode is option to shoot the X-ray with Hand switch.

  • Page 52: Detector Ap Configuration And Operation

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 5.4 Detector AP Configuration and Operation Generally, the detector AP mode is used in a wireless configuration as illustrated below: Wireless communication is established between the PEDRA detector and PC. The PEDRA detector is compliant with IEEE 802.11 a/b/g/n (2.4 ㎓...

  • Page 53: Troubleshooting

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 6 Troubleshooting 6.1 General When you encounter problems or error messages while using this equipment, search the table below for the problem or error messages and try the solutions. If the problem persists, turn off the detector and consult your sales representative or a distributor.

  • Page 54: Maintenance

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 7 Maintenance In order to ensure that the device is used safely and normally, be sure to inspect the device before use. If any problem is found during the inspection and cannot be corrected, please contact your sales rep- resentative or a distributor.

  • Page 55: Function Test

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)  Function test Item Period Description Power consumption Daily Confirm that the power operation of detector is normal. Check the monitoring in order to minimize the characteristic Temperature Daily changes of Flat panel caused by external temperature...

  • Page 56: Information

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 8 Information 8.1 Service information Product lifetime The estimated product lifetime may be up to five (3) years under appropriate regular inspection and maintenance. Regular inspection and maintenance In order to ensure the safety of patients, operating personnel and third parties, and to maintain the performance and reliability of the equipment, be sure to perform regular inspection at least once a year.

  • Page 57: Warranty

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 8.2 Warranty Radisen warrants that this product will be free from defects in materials and workmanship for a period of two (2) years from the date of delivery. If any such product proves defective during this warranty period, Radisen at its option, either will repair the defective product without charge for parts and labor, or will provide a replacement in exchange for the defective product.

  • Page 58: Revision History

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Revision History Revision Date Descriptions 2020.07.25 Initial Release “More than just Digital” Page 58 of 81...

  • Page 59: Annex.1 Generator Interface

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex.1 Generator Interface X-ray SYNC Connect the X-ray SYNC cable to the PEDRA-PCON, 6pin SYNC and the X-ray generator. Tether Cable Pin assignment Tether Cable is female connector to connect between Detector and PEDRA-PCON. “More than just Digital”...

  • Page 60: Appendix.2 Detector Ip Setting

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Appendix.2 Detector IP setting 1. Default IP address wired or wireless configuration if the connection is unstable or setting value information is not clear when you intend to change it. Wire Mode Wireless HUB Mode Wireless Access point Mode...

  • Page 61: Appendix.3 Specifications

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Appendix.3 Specifications 1. PEDRA-1417M Specifications Model & Parameters PEDRA-1417MG PEDRA-1417MC Scintillator S:Tb CsI:Tl (Direct) Sensor Pixel size 140um, a-Si TFT active matrix with PIN diode Pixel Matrix 2500 x 3052 Effective Area...

  • Page 62: Pedra-17F Dimensional Diagram

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2. PEDRA-17F Dimensional diagram Unit: mm “More than just Digital” Page 62 of 81...

  • Page 63: Pedra-Pcon

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3. PEDRA-PCON Item Description Input: 100-240VAC~, 47~63Hz, 1.62-0.72 A AC/DC Adapter Output: DC+15V /4.2A (max) Gigabit Ethernet Ports –1EA USB port - 1EA Cabling Ports X-ray SYNC - 1EA HAND switch –...

  • Page 64: Battery Pack

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 4. Battery Pack This dedicated battery pack is necessary for PEDRA wireless detector. Item Description Model PEDRA-BT001 Type Lithium Polymer Rated Power Supply Output: DC +7.58V Capacity 4000㎃h Number of Cell...

  • Page 65: Battery Charger

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 5. Battery Charger Item Description Model PEDRA-BACH001 Charging 1 battery packs Charging Time 2.5 hours Input: 100-240V~, 50/60Hz, 1.5 A Rated Power Supply Output: DC 15V, 4.0A Dimension (W ×H ×D) 250.0 ㎜×120.0 ㎜×161.5 ㎜...

  • Page 66: Appendix.4 Label And Symbols

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Appendix.4 Label and Symbols PEDRA detector and other components have labels and markings on them. Their contents and locations are indicated below. 1. Detector “More than just Digital” Page 66 of 81...

  • Page 67: Power & Control Box (Pedra-Pcon)

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2. Power & Control Box (PEDRA-PCON) “More than just Digital” Page 67 of 81...

  • Page 68: Battery Charger

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3. Battery Charger 4. Battery Pack “More than just Digital” Page 68 of 81...

  • Page 69: Shipment Label

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 5. Shipment Label  Out box “More than just Digital” Page 69 of 81...

  • Page 70: Annex . 5 Regulatory Information

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex . 5 Regulatory Information 1. Medical equipment safety standards  Medical Equipment Classification Class Ⅰ equipment Type of protection against electrical shock Internally Powered Degree of protection against electrical shock Type B applied parts Degree of protection against ingress of water...
  • Page 71 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)  European Union MDD (93/42/EEC) Medical Device Directive EN ISO 13485:2012+AC:2012 Medical devices –Quality Management systems –Requirements for regulatory purposes EN 60601-1: 2006 Medical electrical equipment-Part1: General requirements for safety IEC 60601-1-2: 2007(ed.3) Medical electrical equipment-Part 1-2: Collateral standard:...

  • Page 72: Annex .6 Serial Number (S/N) Composition

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex .6 Serial Number (S/N) composition The serial numbers for each product and accessory are composed as follows; Product Model Code Sensor Type Secret Place Year Month (Fixed)
  • Page 73 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Composition of serial number for each item Item Serial No. PEDRA-1417FG (GdOS, Fixed Type Detector) M0GFAAH1001 PEDRA-1417FC (CsI, Fixed Type Detector) M0CFAAH1001 PEDRA-1417MC (CsI, Mobile Type Detector) M0CMAAH1001 PEDRA-1417MG (GdOS, Mobile Type Detector) M0GMAAH1001...

  • Page 74: Annex .7 Guidance And Manufacturer's Declaration For Emc

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex .7 Guidance and Manufacturer’s Declaration for EMC This device has been tested for EMI/EMC compliance, but interference can still occur in an elec- tromagnetically noisy location. Attempt to maintain a suitable distance between electrical devices to prevent malfunction.
  • Page 75 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Electromagnetic Immunity The PEDRA is intended for use in the electromagnetic environment specified below. The customer or user of this device should assure that it is used in such an environment. Basic EMC Operating Test lev-...
  • Page 76 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) turbances In- Stand by 240 V,50 Hz duced by 240 V, 60 Hz 6 V in ISM bands RF fields Between 0.15 MHz SIP/SOP and 80 MHz 80% AM at 1 kHz Power Frequency Operating...

  • Page 77: Annex. 8 X-Ray Condition (Referenced)

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex. 8 X-ray condition (Referenced) X-ray Energy Range: 40kVp ~ 150kVp Below exposure conditions were set by CPI generator, CMP200 DR for customer to reference. Large group Middle group...

  • Page 78: Annex. 9 Wireless Communication Specification

    Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex. 9 Wireless Communication Specification Wireless LAN Specification Item Description Wireless Standard IEEE802.11ac/a/b/g/n Frequency Range 2.412GHz~2.484GHz, 5.150MHz~5.850MHz 802.11b: 11Mbps / 802.11a/g: 54Mbps / 802.11n: MCS0~7/ 802.11ac: Data Rate MCS0~9 Bluetooth: 1Mbps, 2Mbps and up to 3Mbps EDR WiFi : 802.11b: DSSS (DBPSK, DQPSK, CCK) 802.11a/g: OFDM (BPSK,...
  • Page 79 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Network IP Address : 192.168.0.11 Port : 5050 WNetwork SSID : PEDRADXD-5G Key : 12345678 AP On/Off : Off Frequency : 5GHz SSID : PEDRA-AP-5G Key : 12345678 Security : WPA2-PSK Detector Parameter...
  • Page 80 Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex. 11 FCC-Related information and explanation Installation Procedure FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. RF Exposure SAR statement RF exposure compliance The available scientific evidence does not show that any health problems are associated with using...
  • Page 81 RadiSen Radisen Co., Ltd. 14F Gongduk B/D, 11, Saechang-ro, Mapo-gu, Seoul, 04168, Republic of Korea Tel. +82-70-7525-2147 Website: http://www.radisentech.com European representative: KTR Europe GmbH. Mergenthalerallee 77, Eschborn, Hessen, 65760, Germany Tel: +49(0)6196-887170 Fax: +49(0)6196-8871728 E-mail: ktreurope@ktreurope.de “More than just Digital”...

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