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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)

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Summary of Contents for Radisen PEDRA-1417M

Page 1: ...anual 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 tho...

Page 2: ...age or loss arising from a fire earthquake any action or accident by a third party any intentional or negligent action by users any trial usage or other usage under abnormal conditions 2 Roentgenograp...

Page 3: ...collection point e g on an authorized one for one basis when you buy a new similar product or to an authorized collection site for recycling electrical and electronic equipment EEE Improper handling o...

Page 4: ...12 2 Introduction 18 2 1 Features 18 2 2 Intended use 18 2 3 Detector Description 19 2 4 Power Control Box PEDRA PCON Description 21 2 5 Battery Charger PEDRA BC001 Description 23 2 6 Battery PEDRA B...

Page 5: ...Wireless Standard Configuration and Operation 49 5 2 AED Mode Configuration and Operation in wired mode 50 5 3 Manual Mode Configuration and Operation in wired mode 51 5 4 Detector AP Configuration a...

Page 6: ...5 Battery Charger 65 Appendix 4 Label and Symbols 66 1 Detector 66 2 Power Control Box PEDRA PCON 67 3 Battery Charger 68 4 Battery Pack 68 5 Shipment Label 69 Annex 5 Regulatory Information 70 1 Med...

Page 7: ...may results in serious injury or accident It is important for you to read and under stand the contents of this manual before attempting to use the product Warning This notice is used to indicate a po...

Page 8: ...ric shock Always be alert when operating this device If a malfunction occurs do not use this device until qualified personnel correct the problems The product should be installed maintained and servic...

Page 9: ...ult in electric shock or malfunction of the device When a problem occurs Should any of the following occur immediately turn OFF the power to each piece of device unplug the power cord from the AC outl...

Page 10: ...ng so may result in failure or malfunction device falling fire or injury Close to facilities where water is used Where it will be exposed to direct sunlight Close to the air outlet of an air condition...

Page 11: ...able covering as necessary Turn OFF the power to each piece of equipment for safety when not being used Do not submerge the device in water The internal image sensor may be damaged if the equipment is...

Page 12: ...reference This mark indicates that this is a Type B Applied Part according to UL 60601 1 and EN 60601 1 Indicates the temperature limits to which the medical device can be safely exposed This mark ind...

Page 13: ...ner may have negative effects on human health and the environment When disposing of this product therefore be absolutely sure to follow the procedure which is in conformity with the laws and regulatio...

Page 14: ...nclude orders a Full Cervical Thoracic and Lumbar Spine series The pediatric radi ologist should contact the ordering physician and decide which study is best for the pediatric patient The technologis...

Page 15: ...age Ship 500 to 1060 hPa Humidity Operation 20 to 75 RH Storage Ship 10 to 95 RH Temperature Operation 10 to 40 C Storage Ship 15 to 55 C Contact duration by operator 10 s t 1 min Operator Accessible...

Page 16: ...ower supply voltage variations Doing so may prevent normal operation of this equipment and peripherals Patient Population Age Infant to geriatric For purposes of this user manual we are defining pedia...

Page 17: ...More than just Digital Page 17 of 81 Doc Name PEDRA User s Manual Doc No PEDRA 1417M UM Initiate date 2020 07 25 Revision date 2020 10 15 Rev 1...

Page 18: ...1 Features The shape of the detector which is identical to that of a conventional film cassette complying with ISO4090 enables digital radiography in the existing analog radiography configuration The...

Page 19: ...images Captured images are transmitted to the viewer computer through a wired and wireless con nection A POWER button Controls the detector power on off B Status indicators a Power LED Indicates powe...

Page 20: ...ision 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 connecti...

Page 21: ...eceives orders from the computer And it transmits digital images from PEDRA detector to the station 1 External power socket AC DC Adopter MPU 64 DC 15V 4 2A INPUT 2 Tether cable port Operation a Detec...

Page 22: ...eration When an event occurs in normal open condition RDY_OUT EXP_OUT and RDY_COM EXP_COM are closed 6 Status lamps a PCON Power LED Power on LED Blue b Exposure LED Generator X ray exposure LED Orang...

Page 23: ...tric 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 4 Battery insertion Inse...

Page 24: ...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 Adap...

Page 25: ...120V 1 Standard Part Item Product Name Detector PEDRA 1417M scintillator CsI TI 3 0kg GdOS 3 20kg Power Control Box PEDRA PCON 0 50kg Battery Charger PEDRA BACH001 0 39kg Battery PEDRA BT001 0 25kg PE...

Page 26: ...ll combinations of device must be compliance with IEC 60601 1 system requirements Any person who connects additional device to the signal input or signal output ports configures a medical system and i...

Page 27: ...EDRA 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 SID 100 130 150 180 cm Size 384mm x 460mm x 1 5mm Ra...

Page 28: ...ive or distrib utor 3 1 Preparations 1 Charge Attach the battery pack Charge the battery on the day of examination or on the previous day Be sure to use only the dedicated battery pack for PEDRA Detec...

Page 29: ...ng the battery by connecting tether interface Charging Source Charging quantity Charging Time Charger 1 battery pack 4hrs Tether Interface 1 battery pack 10hrs How to detach the battery pack Turn off...

Page 30: ...17M 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 b...

Page 31: ...h the wiring connector it is possible to switch from a wireless configuration to a wired configuration see the figure Wired config uration is suitable when the detector is set in a bucky stand and tab...

Page 32: ...Access Point and Station respectively Router Power box and PC are connected with the LAN cable The PEDRA 1417M Wireless detector is compliant with IEEE 802 11a b g n 2 4 5 The available fre quency ban...

Page 33: ...ed wirelessly In this case the detector and the PC operate as AP Access Point and STATION respectively Since Powera box is not used for configuring the detector AP mode you can only use the AED mode w...

Page 34: ...EDRA PCON and the other to the LAN Card Connector of workstation assigned for the Data Transfer 3 4pin SYNC cable connects hand switch and the PEDRA PCON It transmits signals to control the signal fro...

Page 35: ...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 a PCON Power ON O X X b X ray ready Sho...

Page 36: ...linking every 0 5 seconds Lamp type Wired Connection Lamp Active Color Blue Green Orange a Power ON O X X b Network Connection Wired mode X O O blinking c Shooting signal of X ray X O O d Wifi Connect...

Page 37: ...ector for Power adapter is positioned on left side of charger No Description Power lamp Function 1 DC Input power Blue O 15Vdc 4A Max 2 Status LED Green O Charging is on going 3 Done LED Orange 100 O...

Page 38: ...ation computer 1 PedraCalib ZIP file in the PEDRA CD needs to copy in the directory of PEDRA and release the ZIP file 2 PEDRA exe PEDRA_MODULE DLL file is activated in the PEDRA folder 3 After install...

Page 39: ...More than just Digital Page 39 of 81 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...

Page 40: ...osured image is saved in the image folder Logs are saved in the log folder 2 Detector information IP address Port are displayed User can detector set when you click 1 Network Info IP Addr input detect...

Page 41: ...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 De...

Page 42: ...ctor status User can check Detector log User can check Detector status check data 4 Get image for calibration Get a dark image for offset calibration Get a Bright image for gain calibration When you c...

Page 43: ...es 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 3 Selected Bright files Bright files selected from the...

Page 44: ...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 3 clear bad pixel User can add or delete defect pixel Auto or manually for c...

Page 45: ...PEDRACalib 4 3 Calibration Procedure For calibration implementing Manual or AED mode needs to be selected to acquire the secure image dark and bright To calibrate image the five bright images are nee...

Page 46: ...etector IP port then Connect Step 1 Selection of AED mode For more detail information refer to AED mode configuration chapter 5 2 Step 2 Click the button to start acquire Dark Image from the detector...

Page 47: ...ired Bright frame Bright_ image resolution_bit_bright value raw will be generated in the selected folder Bright value LSB is descrived on the table 1 and then it will be acquired 5 different level of...

Page 48: ...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...

Page 49: ...ector 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: ...llow operating environmental requirements Temp 10 40 If you use AED Mode out of operating environmental requirements unwanted image can be acquired without X ray image acquiring Do not hit or drop the...

Page 51: ...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 Manual mode is a wired connection with te...

Page 52: ...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 5 The avai...

Page 53: ...its representatives are not responsible for the detector repair regardless of remaining warranty For more detailed information refer to Warranty p 58 6 2 Detector Symptom Cause Remedy Power Blue LED...

Page 54: ...attempting the following Otherwise an electric shock may result Cable 1 Ensure that cables are not damaged and cable jackets are not torn 2 Ensure that the power cord plugs are securely connected to...

Page 55: ...to get image de signed with optimal specifications Linearity Quarterly Evaluate the distinct characteristics of detector through the amount of radiation coming into Flat Panel Detector reso lution and...

Page 56: ...e adjustments or replace consumables There may be cases where overhaul is recommended depending on the conditions Contact your sales representative or distributor for regular inspections or maintenanc...

Page 57: ...rranty period and make suitable ar rangements for the performance of service Customer shall be responsible for packaging and shipping the defective product to the service center designated by Radisen...

Page 58: ...just Digital Page 58 of 81 Doc Name PEDRA User s Manual Doc No PEDRA 1417M UM Initiate date 2020 07 25 Revision date 2020 10 15 Rev 1 9 Revision History Revision Date Descriptions 0 0 2020 07 25 Initi...

Page 59: ...UM Initiate date 2020 07 25 Revision date 2020 10 15 Rev 1 Annex 1 Generator Interface 1 X ray SYNC Connect the X ray SYNC cable to the PEDRA PCON 6pin SYNC and the X ray generator 2 Tether Cable Pin...

Page 60: ...nge it Wire Mode Wireless HUB Mode Wireless Access point Mode PC 192 168 0 55 Subnet Mask 255 255 255 0 255 255 255 0 PEDRA 192 168 0 11 192 168 0 11 11 11 11 1 2 Change of network setting Network inf...

Page 61: ...tage Range 40 150 Kvp X ray Generator Inter face Line Trigger Manual Auto Trigger AED Mode Shot Mode Single Multi MTF 70 at 0 5lp mm GdOS 77 at 0 5lp mm CsI DQE 20 at 1lp mm GdOS 57 at 1lp mm CsI Imag...

Page 62: ...More than just Digital Page 62 of 81 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...

Page 63: ...2020 07 25 Revision date 2020 10 15 Rev 1 3 PEDRA PCON Item Description AC DC Adapter Input 100 240VAC 47 63Hz 1 62 0 72 A Output DC 15V 4 2A max Cabling Ports Gigabit Ethernet Ports 1EA USB port 1EA...

Page 64: ...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...

Page 65: ...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 Rated Power Supply Input 100 240V 50 60Hz 1 5 A O...

Page 66: ...A 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 co...

Page 67: ...More than just Digital Page 67 of 81 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...

Page 68: ...More than just Digital Page 68 of 81 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...

Page 69: ...More than just Digital Page 69 of 81 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...

Page 70: ...nesthetics NOT suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Product Safety Standards U S A and Canada IEC 60601 1 ed 2 am1 am2 co1 Medica...

Page 71: ...ces 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 equipm...

Page 72: ...1 M 0 A H 0 0 1 Model Code Series Components Rev Year Month Serial number 1 Range of serial number 001 to 999 2 How to apply revision number Apply from 1 0 according to a change of design sequentiall...

Page 73: ...rial 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 1417...

Page 74: ...ectronic equipment RF Emissions CISPR 11 Class A The EUT is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that...

Page 75: ...0 65 Tmax 0 5 dmax 4 dc 3 3 Electrostatic Discharge Im munity EN 61000 4 2 2009 IEC 61000 4 2 2008 Operating Stand by Enclosure 120 V 60 Hz 220 V 60 Hz 230 V 50 Hz 8 kV Contact 2 4 8 15 kV Air Radiate...

Page 76: ...ity EN 61000 4 8 2010 IEC 61000 4 8 2009 Operating Stand by Enclosure 120 V 60 Hz 220 V 60 Hz 230 V 50 Hz 30 A m 50 Hz 60 Hz Voltage dips EN 61000 4 11 2004 IEC 61000 4 11 2004 Operating Stand by AC M...

Page 77: ...Sternum Lat 100 80 32 200 8 Pelvic Pelvis Pelvis AP 100 75 20 200 9 Hip Hip AP 100 75 25 200 10 Upper limb1 Hand Hand PA 100 45 3 100 11 Hand Oblique 100 45 3 100 12 Hand Lat 100 50 3 100 13 Finger Fi...

Page 78: ...OFDM BPSK QPSK 16 QAM 64 QAM 802 11n OFDM BPSK QPSK 16 QAM 64 QAM 802 11ac OFDM BPSK QPSK 16 QAM 64 QAM 256 QAM Bluetooth GFSK 4 DQPSK 8DPSK Transmission Power Max 16dBm Security WEP WPA WPA2 Antenna...

Page 79: ...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 AP On Off Off Frequency 5GHz SSID PEDRA AP 5G Key 12345678 Security WPA2 P...

Page 80: ...th for an uncontrolled equipment and meets the FCC radio frequency RF Exposure Guidelines in Supplement FCC Statement Federal Communication Commission Interference Statement This equipment has been te...

Page 81: ...e Federal Communications Commission This equipment should be installed and operated with minimum distance 0mm between the radiator your body This device and its antenna s must not be co located or ope...

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