FCC ID: 2AXRZPEDRA-1417M Digital Flat Panel X-ray Detector

Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Users Manual PEDRA-1417M Detector (Wired & Wireless) Before using this equipment, be sure to read this users manual thoroughly. Keep this user manual where it is easily accessible. More than just Digital Page 1 of 81 Doc. Name: PEDRA Users 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. Important information on usage and management of the equipment 1 Only a physician or a legally certified operator should use this product. 2 The equipment should be maintained in a safe and operable condition by maintenance personnel. 3 Use only computers and image display monitors complying with IEC 60601-1 or IEC 60950-1. For details, consult your sales representative or a distributor. 4 Use only the dedicated cables. Do not use any cables other than those supplied with this product. 5. professional health care environment. Disclaimer 1. In no event shall Radisen be liable for damage 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. Roentgenography, image processing, image reading, and image data storage must be performed in accordance with the laws of the country or region in which the product is being used. The user is responsible for maintaining the privacy of image data. 3. In no event shall Radisen be liable for personal physical harm or property damage that is sustained when the instructions are not followed or the product is misused. 4. It is the responsibility of the attending physicians to provide medical care services. Radisen will not be liable for faulty diagnoses. 5. In no event shall Radisen be liable for direct or indirect consequential damages arising from the use or unavailability of this product Radisen shall not be liable for loss of image data for any reason. 6. In no event shall Radisen be liable for any damage arising from moving, alteration, inspection or repair by a person other than authorized service engineers. 7. Specifications, composition, and appearance of this product may change without prior notice. More than just Digital Page 2 of 81 Doc. Name: PEDRA Users 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. When disposing this product, therefore, be absolutely sure to follow the procedure which is in conformity with the laws and regulations applicable in your area. European Union (and EEA*) only This symbol indicates that this product is not to be disposed with your household waste, according to the WEEE Directive (2002/96/EC) and your national law. This product should be handed over to a designated 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 of this type of waste could have a negative impact on the environment and human heath due to potentially hazardous substances that are generally associated with EEE. At the same time, your cooperation in the correct disposal of this product will contribute to the effective usage of natural resources. For more information on where you can drop off your waste equipment for recycling, please contact your local city office, waste authority, approved WEEE scheme, or your household waste disposal service.

*EEA: Norway, Iceland, and Liechtenstein The Radisen name and Radisen logo are registered as trademarks of Radisen. Trademarks RadiSen Copyright All rights reserved. Under copyright laws, this manual may not be reproduced, in whole or in part, without the written permission of Radisen. More than just Digital Page 3 of 81 Doc. Name: PEDRA Users 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 1 Safety Information..................................................................................................................................................8 1.1 Safety precautions ..............................................................................................................................................8 1.2 Symbols and detail of marking ................................................................................................................ 12 1.3 Notes for using the equipment................................................................................................................ 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-BT001) Description ...................................................................................................... 23 2.7 Components ........................................................................................................................................................ 24 2.8 Workstation (Recommended).................................................................................................................... 26 2.9 Grid (Recommended not included) ...................................................................................................... 27 3 Detector Installation ........................................................................................................................................... 28 3.1 Preparations ........................................................................................................................................................ 28 1. Charge /Attach the battery pack ........................................................... 28 3.2 Connection ........................................................................................................................................................... 31 3.2.1 Tether Connection............................................................................... 31 3.2.2 Wireless Connection ........................................................................... 32 3.2.3 Detector AP Connection .................................................................... 33 3.3 PEDRA-PCON Connection............................................................................................................................ 34 More than just Digital Page 4 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.4 Turn on the detector...................................................................................................................................... 36 1. Detector status list ................................................................................... 36 3.5 Turn on the Battery Charger...................................................................................................................... 37 4 Detector Operation S/W Setting (PEDRA-DMS) ................................................................................. 38 4.1 Installation............................................................................................................................................................ 38 4.2 PEDRA Detector Manager ........................................................................................................................... 38 4.3 Calibration Procedure .................................................................................................................................... 45 5 Operation .................................................................................................................................................................. 49 5.1 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 and Operation ........................................................................................ 52 6 Troubleshooting .................................................................................................................................................... 53 6.1 General ................................................................................................................................................................... 53 6.2 Detector................................................................................................................................................................. 53 6.3 Power& Control Box (PEDRA-PCON).................................................................................................... 53 6.4 Battery Charger ................................................................................................................................................. 53 7 Maintenance............................................................................................................................................................ 54 Daily inspection ......................................................................................................................................................... 54 Function test ............................................................................................................................................................... 55 8 Information .............................................................................................................................................................. 56 8.1 Service information ......................................................................................................................................... 56 8.2 Warranty................................................................................................................................................................ 57 9 Revision History .................................................................................................................................................... 58 Annex.1 Generator Interface....................................................................................................................................... 59 1. 2. X-ray SYNC........................................................................................................................................................... 59 Tether Cable Pin assignment ..................................................................................................................... 59 Appendix.2 Detector IP setting................................................................................................................................. 60 More than just Digital Page 5 of 81 Doc. Name: PEDRA Users 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................................................................................................................................................................. 66 Power & Control Box (PEDRA-PCON) .................................................................................................. 67 Battery Charger ................................................................................................................................................. 68 Battery Pack ........................................................................................................................................................ 68 Shipment Label.................................................................................................................................................. 69 1. 2. 3. 4. 5. 1. 2. 3. 4. 5. Annex . 5 Regulatory Information........................................................................................................................... 70 1. Medical equipment safety standards.................................................................................................... 70 Annex .6 Serial Number (S/N) composition ...................................................................................................... 72 Annex .7 Guidance and Manufacturers Declaration for EMC ................................................................. 74 Annex. 8 X-ray condition (Referenced) ................................................................................................................ 77 Annex. 9 Wireless Communication Specification............................................................................................ 78 Annex. 9 Default value of detector initialization ............................................................................................ 78 More than just Digital Page 6 of 81 Doc. Name: PEDRA Users 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. It is important for you to read and under-

stand the contents of this manual before attempting to use the product. Warning Caution Caution This notice is used to indicate a potentially hazardous situation which may cause death, severe personal injury or substantial property damage if the instructions are ignored. This notice is used to indicate a potentially hazardous situation which may cause minor personal injury or substantial property damage if the instructions are ignored. Regulatory Federal law restricts this device to sale by or on the order of a physician. More than just Digital Page 7 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 1 Safety Information 1.1 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. Warning Installation and environment of use Do not use or store the device near flammable chemicals such as alcohol, thinner, benzene, etc. If chemicals are spilled or evaporate, it may result in a fire or electric shock through contact with electric parts inside the device. Also, some disinfectants are flammable. Be sure to take care when using them. Do not connect the device with anything other than specified. Doing so may result in fire or electric 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 serviced according to manufacturer maintenance procedures and by manufacturer personnel or other qualified maintenance personnel approved in writing by manufacturer. Operation and maintenance should be done in strict compliance with the operation instructions contained in the manual. The system, in whole or in part, cannot be modified in any way without written approval from manufacturer. Adapter Do not operate the device using any type of adapter other than the one indicated on the rating label. Otherwise, it may result in a fire or electric shock. Do not handle the product with wet hands. You may experience an electric shock that could result in death or serious injury. Do not place a heavy object such as medical device on cables and cords, and do not pull, bend, bundle, or step on them. Doing so may damage their sheath. If you alter them, it may damage the cords which could result in a fire or electric shock. More than just Digital Page 8 of 81 Doc. Name: PEDRA Users 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. Handling Warning Never disassemble or modify the device. Doing so may result in a fire or electric shock. Also, since the device incorporates parts that may cause an electric shock as well as other hazardous parts, touching them may cause death or serious injury. Do not place anything on top of the device. The object may fall and cause an injury. Also, if metal objects such as needles or clips fall into the device, or if liquid is spilled, it may result in a fire or electric shock. Do not hit or drop the device. The device may be damaged if it receives a strong jolt. if the device is used without being repaired this may result in a fire or electric shock. Have the patient take a fixed posture and do not let him or her touch parts unnecessarily. If the patient touches connectors or switches, it may result 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 outlet, and contact our sales representative or distributor. When there is smoke, an odd smell or abnormal sound. When liquid has been spilled into the device or a metal object has entered through an opening When the device has been dropped and is damaged Maintenance and inspection When the device is going to be cleaned, be sure to turn OFF the power of each equipment and unplug the power cord from the AC outlet. Never use alcohol, benzene, thinner, or any other flammable cleaning agent. Otherwise, it may result in a fire or electric shock. Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug, its periphery, and AC outlet with a dry cloth. If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the plug will attract moisture, and this could cause insulation failure that could result in a fire. For safety reasons, be sure to turn OFF the power to each piece of device when the inspections in-

dicated in this manual are going to be performed. Otherwise, electric shocks may occur. More than just Digital Page 9 of 81 Doc. Name: PEDRA Users 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. An authorized operators list should be main-

tained. the authorized operators. It is important that this User Manual be kept at hand, studied carefully, and reviewed periodically by Do not install the equipment in any of the locations listed below. Doing 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-conditioner or ventilation device Close to a heat source such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment Where there is freezing or condensation In areas prone to vibration On an incline or in an unstable area Where temperature or humidity is higher than the operating temperature Because the device cable is long, take care that cables do not become tangled during use. Also, be careful not to get your feet caught in the cable. tripping over the cable. Otherwise, it may cause a malfunction of the device or injury to the user from Non-medical equipment such as the Power supply cannot be used in patients vicinity. Warning Handling More than just Digital Page 10 of 81 Doc. Name: PEDRA Users 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. In such a situation, protect the device with a disposable 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 hit, dropped, or receives a strong jolt. Also, do not place excessive weight on the detector.

<Load Limit>

Uniform load: 150kg over the whole area Local load: 100kg on an area 40 of the detector surface in diameter B e s u r e to use the detector on a flat surface so it will not bend. Otherwise, the internal image sensor may be damaged. Be sure to securely hold the detector while using it in upright positions. More than just Digital Page 11 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 1.2 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-

tation before using the equipment. Keep manual for future reference. This mark indicates that this is a Type B Applied Part according to UL 60601-1 and EN 60601-1. exposed. Indicates the temperature limits to which the medical device can be safely This mark indicates that the equipment must be collected separately under the Directive on Waste Electrical and Electronic Equipment 2002/96/EC (WEEE) in the European Union. (For European Union) Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC,93/42/EEC and98/79/EC. Indicates the date when the medical device was manufactured. Indicates the Authorized representative in the European Community. This mark shows compliance of the essential requirement and other relevant provi-

sions of Directive 93/42/EEC. 1.3 Notes for using the equipment More than just Digital Page 12 of 81 Doc. Name: PEDRA Users 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. This should be done as a routine operation for every patient. If the hard disk of your workstation is about to be full, the operator should backup images and delete them to make storage (memory) space on the hard disk for new information (patient). The PEDRA-DMS (Detector Managing Software) has the technician mode and this mode should be operated by the personnel who are qualified by the manufacturer User Limitations Disposal Disposal of this product in an unlawful manner 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 regulations applicable in your area. Before exposure Be sure to check the device daily and confirm that it works properly. Sudden heating of the room in cold areas will cause condensation to form on the equipment. In this case, wait until the condensation evaporates before performing an exposure. If the equipment is used while condensation is formed in it, problems may occur in the quality of captured images. When an air-conditioner is used, be sure to raise/lower the temperature gradually so that a difference between the temperature in the room and in the equipment does not occur, which prevent con-

densation. During exposure noise or artifacts. Cleaning and Disinfection This device is not protected (sealed) against liquids such as blood and medicine in the operating room. If necessary, wrap the equipment in a disposable cover when using. Do not use the detector near devices generating a strong magnetic field. Doing so may produce image More than just Digital Page 13 of 81 Doc. Name: PEDRA Users 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. For details on how to sterilize, consult a specialist. Use a dry cloth slightly damped with such disinfectants to wipe the surface of the detector and its peripheral equipment. Do not spray the detector directly with disinfectants or detergents. Do not clean the detector with substances containing organic solvents such as alcohol, benzene, thinner, or other chemicals. Otherwise, it may result in an unwanted fire or electrical shock or structural weakening of Do not use an abrasive brush, scraper, or acid/alkaline cleaner when cleaning the detector and other the detector. equipment. Do not clean the detector with its power on. Pediatric Application Every request should be reviewed by a pediatric radiologist prior to beginning the examination to ensure that an appropriate study is being performed. If the technologist notices an unusual request, he or she must contact a pediatric radiologist. Examples, include 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 technologist should use a proper technique considering the patients size to decrease the radiation dose when he or she acquires diagnostic images. ALL pediatric patients shall be shielded for their X-ray examinations, except for when the shield will obscure the region of interest, as in a pelvic or SI joint X-ray for trauma or arthritis, or when it is physically or clinically unreasonable to shield the patient. For routine Hip X-Rays, ALL male children shall have their scrotum shielded using the small gonadal shield while females may not be shielded because doing so would obscure the hips. To minimize motion in infants and young children, swaddle the infant. Use distraction tools to improve cooperation and projectors with child-friendly themes, music, toys with flashing lights or music, child- friendly images on the ceiling or walls, singing, counting, and a parent reading and talking to the child through the console all can help reduce anxiety and comfort the child. A scoliosis series will consist of a single frontal standing view of the spine. No lateral view or supine view is needed, unless specifically asked for by the Orthopedist or Radiologist. If the females breasts can be shielded without obscuring the spine, breast shields should be used. Operating/storage environment More than just Digital Page 14 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Vac Hz hPa hPa

% RH

% RH C C 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. Be sure to use and store this equipment under the conditions described below:

Parameter Value Units AC/DC Adapter setting

(when supplying from the output source of Adapter) Frequency

+/-10% of rated voltage 50/60 Factor Voltage Pressure Operation 700 to 1060 Storage/Ship 500 to 1060 Environmental Humidity Temperature Operation 20 to 75 Storage/Ship 10 to 95 Operation 10 to 40 Storage/Ship

-15 to 55 10 s t < 1 min Contact duration by operator Contact duration by Patient Material Group Pollution Degree Max. working condition Detector & Power Supply for wired communication) Max. working condition

(Digital X-ray Flat Panel Operator Accessible Part Enclosure of Power Supply and X-ray Detector Patient Accessible Part Enclosure of X-ray Detector (PC Film) 1 min t < 10 min IIb 2 Overvoltage Category II(When supplying from Power Supply)

(Digital X-ray Flat Panel Continuous operated with fully charged battery and cycles for image capture and transmission from Detector to PC Continuous cycles for image capture and transmission from Detector to PC More than just Digital Page 15 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Detector & Power Supply for wireless communication) they are safe and cannot fall down. Others 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 Do not use this device in combination with peripherals such as defibrillators or large electric motors as these may cause power-supply noise or power 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 pediatric subpopulations as shown below. Pediatric Subpopulation Approximate Age Range newborn birth to 1 month of age infant child 1 month to 2 years of age 2 to 12 years of age adolescent 12-21 years of age Adult patient, Body type (age 22 or above) index) table. Body type is divided considering the patient height and weight which are shown as below BMI (body mass BMI Weight Status Below 18.5 Underweight 18.5 24.9 Normal 25.0 29.9 Overweight 30.0 and Above Obese Health: Patients requiring an X-ray may have conditions ranging from mild trauma to chronic, life threatening illnesses. More than just Digital Page 16 of 81 Doc. Name: PEDRA Users 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 Doc. Name: PEDRA Users 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. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network. 2.1 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 new sensor with 143 m of pixel pitch and CsI (Cesium Iodide) / GdOS (Gadolinium Oxysulfide)used for the scintillator produces high-resolution digital images within the effective imaging area (CsI: 350 x 430

) with low doses of X-rays. Depending on the operating conditions at each site, the wiring unit (optional) enables the equipment to be used through expansion to a wired connection. Wireless LAN communication (IEEE 802.11 a/b/g/n) includes thin detector that is easy to handle. At the time of installation, set a specific channel in the double frequency band of 2.4 /5 before using the LAN. Note that the available frequency band for this standard varies depending on the local radio laws, regulations, and system requirements. 2.2 Intended use The PEDRA 1417M 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 system in all general-purpose diagnostic procedures. It is not to be used for mammography. More than just Digital Page 18 of 81 Doc. Name: PEDRA Users 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. A. POWER button: Controls the detector power on/off B. Status indicators a. Power LED: Indicates power on/off status

(Blue). b. Network LED: Network Connection status of wired mode (Green) c. Exposure status : Shooting signal of dark and X-ray (Yellow) d. Wifi LED: Wireless status of AP mode

(Green) e. Battery LED: Battery power (Green) More than just Digital Page 19 of 81 Doc. Name: PEDRA Users 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).

(1) Battery connection parts

(2) AP mode On/Off button: User can select AP mode or Wifi (or tether) mode.

(3) SD card Slot : saved images storage D. Wifi Antenna E. Battery Connector E More than just Digital Page 20 of 81 Doc. Name: PEDRA Users 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.

(1) External power socket: AC/DC Adopter [MPU-64], DC +15V / 4.2A INPUT

(2) Tether cable port:

Operation: a. Detector power supply b. Control signal input section c. Network signal communication

(3) LAN port: 10/100/1000 BASED-T Data communication port

(4) Hand switch SYNC port: READY/EXPOSURE in port Operation: When the EXP_IN / RDY_IN of initial state for 5V is connected Pin No.2(GND), signals of RDY_IN, EXP_IN is transmitted to the detector. More than just Digital Page 21 of 81 Doc. Name: PEDRA Users 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:

a. PCON Power LED: Power on LED (Blue) b. Exposure LED: Generator X-ray exposure LED (Orange) / at DMS and Manual Mode activated c. Detector Power LED: Power on LED (Green)

(7) Detector Power On/Off switch

(8) USB connector:

Operation: a. Supply power to N-GENSYNC b. Data Communication with PC More than just Digital Page 22 of 81 Doc. Name: PEDRA Users 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.

(4) Battery insertion: Insertion part for battery charging 2.6 Battery (PEDRA-BT001) Description

(1) Model: PEDRA-BT001

(2) Type: Lithium-ion

(3) Rating: DC 11.1V. 4.0Ah

(4) Operation time: 4hr.

(5) Cycle time: max 250 times (Fully charged/Discharged completely, 1cycle) More than just Digital Page 23 of 81 Doc. Name: PEDRA Users 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 24 of 81 Doc. Name: PEDRA Users 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 Detector Product Name 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 PEDRA CD PEDRA-DMS (Detector Manager Software) User Manual AC/DC Adapter (2m) AC/DC Adapter for Battery Charger (2m) Accessories Generator SYNC Cable (15m) Tether Cable (7.5~10m) LAN Cable (15m, Direct, 1000BASE-T, CAT 5E) More than just Digital Page 25 of 81 Doc. Name: PEDRA Users 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. as replacement parts for internal components, may result in increased radiation emissions or decreased stability of the equipment. Accessory device connected to the analog and digital interfaces must be certified according to the respective IEC standards. All 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 is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1. If in doubt, consultmanufacturer technical support representative. 2.8 Workstation (Recommended) Operating System Windows 8, 10, 64 bit SP1 (Professional Edition or higher) Intel Core i5 2600 or higher (or compatible CPU) Specification Item CPU Memory Hard Disk LAN Card 4GB or higher 1TB or higher Gigabit (Detector only) Intel? PRO 1000 Series

(Gigabit LAN Card for network interface) Min. Requirements: 1Gbps, Jumbo Frames: 9K Receive Descriptors: 2K (higher than 1024) This is not dedicated to DICOM Monitor 1024 X 768 or higher Optical Disc Drive CD or DVD R/W More than just Digital Page 26 of 81 Doc. Name: PEDRA Users 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 SID Size Ratio Frequency Inter spacer Description 100 /130/150/180 cm 384mm x 460mm x 1.5mm 200 Line/inch 10 : 1 AL More than just Digital Page 27 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 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-

3 Detector Installation 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 Detector. How to attach the battery pack Align the claw on the battery pack and the groove on the battery bay .Make sure that the claws on the battery pack are aligned with the groove on the battery compartment. Slide the battery pack into the battery compartment of the detector. Push down the battery pack. Slide the battery lock lever until it clicks into place. More than just Digital Page 28 of 81 Doc. Name: PEDRA Users 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 (quantity) Charging Time Charger 1 battery pack Tether Interface 1 battery pack 4hrs 10hrs How to detach the battery pack Turn off the detector Press and hold the POWER button. (approx. 1.0 seconds) All the LED lamps are off. Remove the battery pack While holding down the battery pack, slide the lock levers as shown below (unlock) (1), put your fingers on the battery pack edge that lifts up, and then pull the edge to remove the battery pack (2). More than just Digital Page 29 of 81 Doc. Name: PEDRA Users 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. More than just Digital Page 30 of 81 Doc. Name: PEDRA Users 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). Wired config-

uration is suitable when the detector is set in a bucky stand and table in place of a film cassette. In this configuration, for the reason that data communication and power supply are made via a cable, users do not have to be concerned about the remaining battery power and wireless communication failure. This reduces the time and labor involved in charging and replacing the battery. More than just Digital Page 31 of 81 Doc. Name: PEDRA Users 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. 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 band may vary depending on local radio laws and system requirements. Consult your local dealer for the frequency available in your area.

- Use of multiple WLAN devices within the same frequency band may interfere with each wireless communication and cause a decline in transmission speed.

-. Do not cover or block the wireless module of the detector. Otherwise, the trans-

mission speed or operable distance may be reduced. More than just Digital Page 32 of 81 Doc. Name: PEDRA Users 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. Since Powera box is not used for configuring the detector AP mode, you can only use the AED mode without a wired connection. (Cannot use the Line Trigger mode.) This mode can be used when mobility and portability are needed. When configuring the detector AP mode, be sure to check the specifications of wireless module installed in the PC. The wireless communication performance can be different depending on the specifications of the wireless module. More than just Digital Page 33 of 81 Doc. Name: PEDRA Users 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. 3) 4pin SYNC cable connects hand switch and the PEDRA-PCON. It transmits signals to control the signal from generator. It is particularly designed for manual mode. 4) Connect the one end of the generator SYNC cable, 6pin to the PEDRA-PCON, and the other to the port of the X-ray generator. 5) Detector Power On/Off switch 6) USB 2.0 cable connects work station computer and the PEDRA-PCON, transmits signals to control the signal from generator. It is particularly designed for manual mode. More than just Digital Page 34 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) a b c Lamp type [only for wired connection]

PCON Power X-ray Exposure Detector Power Color Blue Orange Green a. PCON Power ON b. X-ray ready & Shot c. Detector Power ON PCON Power OFF O: Lights on X: Lights off O O O X X O X X X O O X More than just Digital Page 35 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3.4 Turn on the detector 1. 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. Lamp type [Wired Connection]

Lamp Blue Green Color a. Power ON b. Network Connection [Wired mode]

c. Shooting signal of X-ray d. Wifi Connection [Wireless mode]

e. Battery Power status Power OFF O: Lights on X: Lights off Color a. Power ON b. Network Connection [Wired mode]

c. Shooting singal of X-ray d. Wifi Connection [Wireless mode]

e. Battery Power status Power OFF O X X X X X O X X X X X Lamp type [Wireless Connection]

Lamp Blue Green X O O X X X X X X O O X Active Orange O [blinking]

Active Orange O [blinking]

X O X X X X X X X X More than just Digital Page 36 of 81 Doc. Name: PEDRA Users 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. 1 2 3 4 5 6 7 No. Description Power lamp Function DC Input power (Blue) 15Vdc 4A(Max) Status LED (Green) Charging is on going Done LED (Orange) 100%

Charging done LED1 (Green) 20%

LED2 (Green) 40%

LED3 (Green) 60%

LED4 (Green) 80%

When charging, LED On When charging, LED On When charging, LED On When charging, LED On O O O O O O O 1 2 3 4 5 6 7 More than just Digital Page 37 of 81 Doc. Name: PEDRA Users 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. 4.1 Installation 1. 2. ZIP file. It needs to Copy PedraCalib folder from the PEDRA CD to the workstation computer. PedraCalib.ZIP file in the PEDRA CD needs to copy in the directory of PEDRA, and release the PEDRA.exe, PEDRA_MODULE.DLL file is activated in the PEDRA folder. 3. After installation the acquired clinical image files are stored as PEDRA__date_number of frame.raw at the same folder, as well as bellow files.

- Dark.raw, bright.raw, bpm.raw files are also activated for image calibration.

The log file of PEDRA detector for operating is stored at the log.ini file. 4.2 PEDRA Detector Manager operation of PEDRA Series. The set-up of PEDRA Detector Manager Software (hereinafter PedraCalib) Manager is necessary for the More than just Digital Page 38 of 81 Doc. Name: PEDRA Users 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 Doc. Name: PEDRA Users 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.

(2) Detector information IP address & Port are displayed. User can detector set when you click 1 Network Info

- IP Addr : input detector IP address

- Port : input detector Port Port settings. port settings.

: If user use a wired detector, user can automatically call up the default IP and

: If user use a wifi detector, user can automatically call up the default IP and

: User can Connect detector.

: If the detector is connected, it can be disconnected. More than just Digital Page 40 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 2 Detector Parameter

- Detector resolution & bit

- image rotate by CW +90

- Use AED or Manual mde (image can be acquired to Hand Switch connection with PEDRA-PCON)

- Detector advanced setting (do not set in normal user)

: Get Detector parameter from Detector

: Send Detector parameter to detector 3 Calibration Prameter

- Calibration advanced setting (do not set in normal user) 4 Clipping More than just Digital Page 41 of 81 Doc. Name: PEDRA Users 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

: Get a dark image for offset calibration.

: Get a Bright image for gain calibration. When you click the button detector ready for get X-ray image

: Get a raw image for image check.

: Call the last raw image.

: Cancel calibration.

(5) RUN Calibration

- A calibration file (BPM) is created using the saved dark and bright files.

- if user need to add bad pixel or line, user can clear.

: user can make calibration. More than just Digital Page 42 of 81 Doc. Name: PEDRA Users 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 calibration. 3 Selected Bright files for calibration.

- Dark files, selected from the dark files acquired by the user for calibration. User can select up to five for

- Bright files, selected from the bright files acquired by the user for calibration. User can select up to five After select dark & bright files, user can make BPM file when click Run.

: User can delete bad pixel or line. More than just Digital Page 43 of 81 Doc. Name: PEDRA Users 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.

- User can add or delete defect pixel Auto or manually for calibration. 2 image tools

- User can adjust zoom 3 clear bad pixel 4 bad pixel location

- User can check bad pixel location.

(6) Refresh & Delete file

: Refresh the list

: Delete the selected dark or bright files More than just Digital Page 44 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) User can check the PEDRACalibs log. (Click once more to disappear.)

: User can check the dark or bright image. (Click once more to disappear.)

(7) Log & Image view

bright.

: Exit the PEDRACalib. 4.3 Calibration Procedure For calibration implementing, Manual or AED mode needs to be selected to acquire the secure image, dark and To calibrate image, the five bright images are needed at five different levels of median values to be adjusted the KVP. The values of bright image is as below for the five images. Point Offset 1 2 3 4 5 Bright Val-

ue[LSB]

Offset Pixel value Offset +

(14000~16000) Offset +

(24000~26000) Offset +

(34000~36000) Offset +

(44000~46000) Offset +

(54000~56000) Table 1: Bright value More than just Digital Page 45 of 81 Doc. Name: PEDRA Users 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. Click the button to start acquire Dark Image from the detector. The Dark Image will save as Dark_image resolution_bit_YYYYMMDD_HHMMSS.raw (The acquired dark frame will be generated in the selected folder.) Dark image will be acquired 5 images. More than just Digital Page 46 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 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 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 bright images. Step 3. Step 4. After Step3, Click the button Select the desired Dark file and 5 Bright files each, and click . If you want to cancel the selection, select the file and click . When the selection of dark and bright files is completed, click RUN to create the BPM file. More than just Digital Page 47 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Step 5. on the X-ray Generator. Getting raw image: Select the AED or Manual mode and shoot the X-ray using the Hand switch or shoot button The way of the image acquiring is referenced to AED or Manual mode operating, chapter 5.2 and 5.3. More than just Digital Page 48 of 81 Doc. Name: PEDRA Users 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 / 5 ). The available frequency band may vary depending on local radio laws and system requirements. Consult your distributor for the frequency available in your area. Appendix.2 is showing the method how to set up the default IP address. More than just Digital Page 49 of 81 Doc. Name: PEDRA Users 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;

1) Selection of AED mode 2) Shoot the X-ray using hand switch of X-ray generator. Make sure to follow 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 equipment. Unwanted images may be acquired in the AED Mode if it receives strong jolt. If you use a Grid under general imaging condition (Dose) or image a thick object in the AED Mode, the efficiency of X-ray transformation may be reduced about 0% ~ 2%

compared to the Manual Mode according to the thickness of the target. If you image a thick object in the AED Mode with low X-ray tube voltage, an image may not be acquired or horizontal line noise may occur. More than just Digital Page 50 of 81 Doc. Name: PEDRA Users 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. Manual mode is a wired connection with tether cable and USB cable to communicate with PC via LAN cable. The way of image acquiring is follows, 1) Selection of Manual mode 2) Shoot the X-ray using hand switch (Option part) of PEDRA-PCON. More than just Digital Page 51 of 81 Doc. Name: PEDRA Users 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 / 5 ). The available frequency band may vary depending on local radio laws and system requirements. Consult your distributor for the frequency available in your area. Appendix.2 is showing the method how to set up the default IP address. More than just Digital Page 52 of 81 Doc. Name: PEDRA Users 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. Please refer to the details of the problem or error messages. Troubleshooting must be performed by a technician who is trained by Radisen or an organization certified by Radisen. If an unqualified person performs troubleshooting on the system resulting in damaging the detector, software or hardware, then Radisen or 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 does not The communication circuit is not and power switch of detector is turned on. light up secured. If it still does not work, replace the de-

Check if tether cable is securely plugged tector. Network (Green) LED does The network communication is not light up not secured Check if LAN cable is securely plugged 6.3 Power& Control Box (PEDRA-PCON) Symptom Cause Remedy Power (Blue) LED does not The communication circuit is not Check if Adapter is securely plugged in. If light up secured. it still does not work, replace the PCON 6.4 Battery Charger Symptom Cause Remedy Power (Blue) LED does not The communication circuit is not light up secured. Check if Adapter is securely plugged in. If it still does not work, replace the Charger or check its Adapter. More than just Digital Page 53 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 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-

7 Maintenance resentative or a distributor. Daily inspection For safety reasons, be sure to turn OFF the power to each piece of device before attempting the following. Otherwise, an electric shock may result. 1) Ensure that cables are not damaged and cable jackets are not torn. 2) Ensure that the power cord plugs are securely connected to both the device AC inlet and the AC 1) Ensure that there are no loose screws or breaks. 2) Ensure that there is no dust or foreign matter on the detector surface and connectors. Federal law restricts this device to be dealt or operated by a physician or medical Use a dry cloth to clean surfaces of the device. Do not use detergents or organic solvents to clean the Do not use abrasive brush, scraper, or acid/alkaline cleaner when cleaning your Cable outlet. Detector Cleaning device. assistant. product. More than just Digital Page 54 of 81 Doc. Name: PEDRA Users 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. Temperature Daily changes of Flat panel caused by external temperature Check the monitoring in order to minimize the characteristic changes. Hard disk space Daily consecutive shootings. Check if the hard disk is enough to save images and allow the Resolution Monthly Confirm the resolution of the detector. Image Acquisition Time Monthly Linearity Quarterly DQE Quarterly MTF Quarterly Calibration Annually Confirm the acquisition of time required to get image de-

signed with optimal specifications. Evaluate the distinct characteristics of detector through the amount of radiation coming into Flat Panel Detector, reso-

lution and contrast of images/projections, and the unification of noises of projection. Evaluate the distinct characteristics of detector through the amount of radiation coming into Flat Panel Detector, reso-

lution and contrast of images/projections, and the unification of noises of projection. Evaluate the distinct characteristics of detector through the amount of radiation coming into Flat Panel Detector, reso-

lution and contrast of images/projections, and the unification of noises of projection. Compensates defect pixels and calibrates pixel gain using the installed X-ray generator and X-ray tube. More than just Digital Page 55 of 81 Doc. Name: PEDRA Users 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 maintenance. Regular inspection and maintenance The estimated product lifetime may be up to five (3) years under appropriate regular inspection and 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. If necessary, clean up the equipment, make 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 maintenance. Repair If a problem cannot be solved even after taking the measures indicated in Troubleshooting and contact your sales representative or a distributor for repairs. Please refer to the name label and provide the following information:

Product name:

Serial number:

PEDRA Wireless Detector 11-digit number indicated on the name label Description of problem:

In as much detail as possible Replacement parts support Performance parts (parts required to maintain the functioning of the product) of this product will be stocked for seven years after discontinuance of production, to allow for repair. More than just Digital Page 56 of 81 Doc. Name: PEDRA Users 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. In order to obtain service under this warranty, Customer must notify of the defect before the expiration of the warranty 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 with shipping charges prepaid. This warranty shall not apply to any defect, failure, or damage caused by improper or inadequate maintenance and care. Radisen shall not be obligated to furnish service under this warranty to repair damage resulting from attempts by personnel other than Radisen or its representatives to install, repair, or service this product, to repair damage resulting from improper use or connection to in-

compatible equipment or power source; or to service a product that has been modified or integrated with other products when the effect of such modification or integration increases the time or difficulty of servicing the product. More than just Digital Page 57 of 81 Doc. Name: PEDRA Users 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 Initial Release More than just Digital Page 58 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-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 assignment Tether Cable is female connector to connect between Detector and PEDRA-PCON. More than just Digital Page 59 of 81 Doc. Name: PEDRA Users 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 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 information can be changed using USB memory stick as follow. 1) Change Network information of the network.ini Text file. 2) Store changed network information to the USB memory stick. 3) Insert USB memory stick to the PEDRA detector. 4) Network information changed automatically. If there is # in front of the text, it will be deactivated More than just Digital Page 60 of 81 Doc. Name: PEDRA Users 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 Sensor Pixel size 140um, a-Si TFT active matrix with PIN diode GD2O2S:Tb CsI:Tl (Direct) Pixel Matrix 2500 x 3052 Effective Area 350.0 x 427.0 mm Image mance perfor-

Spatial Resolution 3.4 lp/mm ADC Resolution 16 bits Grayscale 65536 grayscales x-ray voltage Range 40 ~ 150 Kvp X-ray Generator Inter-

Line Trigger(Manual)/ Auto Trigger(AED Mode) Shot Mode Single / Multi

>70% at 0.5lp/mm (GdOS)

>77% at 0.5lp/mm (CsI)

>20% at 1lp/mm (GdOS)

>57% at 1lp/mm (CsI) face MTF DQE Image Acquisition Time 2.5 sec Mechanical Weight GD2O2S:Tb / 3.10 Kg CsI / 3.20 kg Dimensions Meet ISO4090 for 35x43 (14x17) cassette size Communications Wired Giga Ethernet (1000BaseT)

(384x460x15mm) Wireless IEEE802.11n/2.4 or 5Gbps Sync. Out Port 2 port / TTL(0~5.0V) Operation Software Window 7,8,10

(Console S/W) Support for 32/64bits Windows Power/

Environment Wired Wireless DC +15V Max. 1 Pack(Battery/12.6V/ 3.5 hour) Environment T(10~+40)/H(20 ~ 75%)/P(70~106KPa)

* Specifications are subject to change without prior notification More than just Digital Page 61 of 81 Doc. Name: PEDRA Users 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 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 3. PEDRA-PCON AC/DC Adapter Cabling Ports Item Description Input: 100-240VAC~, 47~63Hz, 1.62-0.72 A Output: DC+15V /4.2A (max) Gigabit Ethernet Ports 1EA USB port - 1EA X-ray SYNC - 1EA HAND switch 1EA Dimensions (W H D) 200 115 36.2 Weight 0.50 Dimensional diagram Unit: mm More than just Digital Page 63 of 81 Doc. Name: PEDRA Users 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 PEDRA-BT001 Lithium Polymer Model Type Life Weight Rated Power Supply Output: DC +7.58V Capacity Number of Cell 4000h 3S1P (3 Series 1 Parallel) Dimension (W H D) 219 166.5 8.0 0.30kg Approx. 500 times (charge/discharge 1cycle) More than just Digital Page 64 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 5. Battery Charger Model Charging Charging Time Rated Power Supply Dimension (W H D) Weight Item Description PEDRA-BACH001 1 battery packs 2.5 hours Input: 100-240V~, 50/60Hz, 1.5 A Output: DC 15V, 4.0A 250.0 120.0 161.5 0.6 Dimensional diagram (Battery Charger) More than just Digital Page 65 of 81 Doc. Name: PEDRA Users 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 Doc. Name: PEDRA Users 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 Doc. Name: PEDRA Users 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 Doc. Name: PEDRA Users 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 Doc. Name: PEDRA Users 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 Type of protection against electrical shock Class equipment Internally Powered Degree of protection against electrical shock Type B applied parts Degree of protection against ingress of water IPXO Mode of operation Continuous operation Flammable anesthetics anesthetic mixture with air or with oxygen or nitrous NOT suitable for use in the presence of a flammable Product Safety Standards U.S.A and Canada UL 60601-1(ed.1) IEC 60601-1(ed.2 am1+am2+ co1) Medical electrical equipment-Part1: General requirements for CSA-C22.2 No. 601-1-M90(R2006)

(R2006) Medical electrical equipment Part1: General re-

quirements for safety (adopted amendment 2:1995 to IEC IEC 60601-1-2: 2007(ed.3) Medical electrical equipment-Part 1-2: Collateral standard:

Electromagnetic compatibility IEC 62304:2006-Ed.1.0 EN ISO 14971:2012 Medical device software-software life cycle processes Medical Device-Application of risk management to medical oxide safety 601-1:1990) devices More than just Digital Page 70 of 81 Doc. Name: PEDRA Users 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 EN 60601-1: 2006 Medical electrical equipment-Part1: General requirements for regulatory purposes for safety IEC 60601-1-2: 2007(ed.3) Medical electrical equipment-Part 1-2: Collateral standard:

IEC 62304:2006 EN ISO 14971: 2012 Electromagnetic compatibility-Requirements and tests Medical device software-Software life cycle processes Medical device Application of risk management to medical devices More than just Digital Page 71 of 81 Doc. Name: PEDRA Users 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 Accessory M 0 G F A A H 0 0 1 Model Code Sensor Type Secret

(Fixed) Type Code Code Rev Year Month Serial number 1 Place Code PC/CH/BT 1 M H 0 0 1 Model Code Series Components Month Serial number 0 Rev A Year 1. Range of serial number 001 to 999. 2. How to apply revision number

: Apply from1.0 according to a change of design sequentially. 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 A B C D E F G H 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 A B C D E F G H I I J J K K L L 3. Initials per year 4. Secret code 5. Initial per month 1 A 2 B 3 C 4 D 5 E 6 F 7 G 8 H 9 I 10 J 11 K 12 L 6. Sensor type : C CsI G GdOS 7. Type code : M Mobile F Fixed 8. Place code : 1 Republic of Korea 2 Outside the Republic of Korea More than just Digital Page 72 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) 9. Composition of serial number for each item Item Serial No. PEDRA-1417FG (GdOS, Fixed Type Detector) PEDRA-1417FC (CsI, Fixed Type Detector) M0GFAAH1001 M0CFAAH1001 PEDRA-1417MC (CsI, Mobile Type Detector) M0CMAAH1001 PEDRA-1417MG (GdOS, Mobile Type Detector) M0GMAAH1001 PEDRA-PCON (Power Supply & Control Box) PEDRA-BACH001 (Battery Charger) PEDRA-BT001 (Battery Pack) PC1M0AH001 CH1M0AH001 BT1M0AH001 More than just Digital Page 73 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Annex .7 Guidance and Manufacturers 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. Electromagnetic Emissions RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/

Flicker emissions Complies IEC 61000-3-3 The Equipment Under Test (EUT) is intended for use in the electromagnetic environment specified below. The customer or user of the EUT should assure that it is used in such an environment. Immunity Test Compliance Electromagnetic Environment Guidance The EUT uses RF energy only for its internal function. Therefore, Group 1 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The EUT is suitable for use in all establishments other than Class A domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the PEDRA-1417M, in-

cluding cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and

(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user hospitals might need to take mitigation measures, such as relocating or re-orienting the equipment. More than just Digital Page 74 of 81 Doc. Name: PEDRA Users 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. Phenomenon standard or test Port tested Test Voltage Basic EMC method Operating mode Test lev-

el/requirement disturbance CISPR11:2015 Operating AC Mains 220 V, 60 Hz Group1, Class A 120 V, 60 Hz 230 V,50 Hz 120 V, 60 Hz 230 V,50 Hz Mains terminal voltage Radiated dis-

turbance Flicker Emission Electrostatic Discharge Im-

munity EN

+A2:2010 Immunity to EN CISPR11:2015 Operating Enclosure 220 V, 60 Hz Group1, Class A Harmonic Cur-

EN 61000-3-2:2014 rent Emission IEC 61000-3-2:2014 Voltage change, Voltage fluctua-

EN 61000-3-3:2013 tions and IEC 61000-3-3:2013 Operating Stand by Operating AC Mains 230 V,50 Hz Class A AC Mains 230 V,50 Hz Tmax:0.5 EN 61000-4-2:2009 IEC 61000-4-2:2008 Operating 120 V, 60 Hz Enclosure 220 V, 60 Hz Stand by 230 V,50 Hz Radiated RF 61000-4-3:2006+A2:

Operating 120 V, 60 Hz 3 V/m Electromagnetic 2010 Enclosure 220 V, 60 Hz 80 MHz-2.7 GHz Field Immunity IEC 61000-4-3:2006 Stand by 230 V,50 Hz 80% AM at 1 kHz Proximity Fields 61000-4-3:2006+A2:

Operating 120 V, 60 Hz Table 9 in from RF wireless 2010 Enclosure 220 V, 60 Hz IEC 60601-1-2:

Communications IEC 61000-4-3:2006 Stand by 230 V,50 Hz 2014 Equipment

+A2:2010 Electrical Fast Transient/Burst Immunity EN 61000-4-4:2012 IEC 61000-4-4:2012 Operating AC Mains 120 V, 60 Hz Stand by SIP/SOP 230 V,50 Hz 220 V, 60 Hz Pst: 1 Plt: 0.65 dmax: 4%

dc: 3.3%

8 kV/Contact 2, 4, 8, 15 kV/Air 2 kV, 100 kHz repetition frequency 1 kV, 100 kHz repetition frequency Line to Line 0.5 kV, 1 kV kV Surge Immunity EN 61000-4-5:2014 IEC 61000-4-5:2014 Operating 120 V, 60 Hz AC Mains 220 V, 60 Hz Line to Ground Stand by 230 V,50 Hz 0.5 kV, 1 kV, 2 Immunity to EN 61000-4-6:2014 Operating 100 V, 50 Hz 3 V AC Mains Conducted Dis-

IEC 61000-4-6:2013 100 V, 60 Hz 0.15-80 MHz More than just Digital Page 75 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) turbances In-

duced by RF fields Stand by 240 V,50 Hz 240 V, 60 Hz 6 V in ISM bands SIP/SOP Power Frequency Magnetic Field Immunity EN 61000-4-8:2010 IEC 61000-4-8:2009 Operating 120 V, 60 Hz Enclosure 220 V, 60 Hz Stand by 230 V,50 Hz Voltage dips IEC 61000-4-11:

AC Mains 0 % UT; 1 cycle EN 61000-4-11:2004 Operating 2004 Stand by Between 0.15 MHz and 80 MHz 80% AM at 1 kHz 30 A/m 50 Hz & 60 Hz 0 % UT: 0.5 cycle At 0, 45, 90, 135, 180, 225, 270 and 100 V, 50 Hz 100 V, 60 Hz 240 V,50 Hz 240 V, 60 Hz 315 and 70 % UT; 25/30 cycles Single phase: at 0 100 V, 50 Hz 100 V, 60 Hz 0 % UT; 250/300 240 V,50 Hz cycle 240 V, 60 Hz Voltage interrup-

tions EN 61000-4-11:2004 Operating IEC 61000-4-11:

AC Mains 2004 Stand by More than just Digital Page 76 of 81 Doc. Name: PEDRA Users 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. No. group Middle group Small group SID(Cm) kVp mAs Large Chest Pelvic Upper limb1 Upper limb2 Lower imb2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Head Skull Nasal Bone Nasal bone Lat Sternum Sternum Lat Skull PA Skull Lat SkullTown's Chest PA Rib AP Pelvis AP Hip AP Hand PA Hand Oblique Hand Lat Finger AP Finger Lat Wrist PA Wrist Lat Forearm AP Forearm Lat Elbow AP Elbow Lat Humerus AP HumerusLat Foot AP Foot Lat Ankle AP Ankle Lat Knee Lat 100 100 100 100 180 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 Chest Rib Pelvis Hip Hand Finger Wrist Forearm Elbow Humerus Clavicle Foot Ankle Shoulder Shoulder AP Clavicle AP Clavicle Tangen-

Lower Knee 125 70 70 74 48 66 80 75 75 45 45 50 45 45 48 50 50 50 50 50 55 55 55 55 58 48 52 55 55 55 mA 200 200 200 100 320 320 200 200 200 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 20 20 25 4 3 20 32 20 25 3 3 3 3 3 3 3 3 4 4 4 4 4 5 5 5 3 4 4 4 4 More than just Digital Page 77 of 81 Doc. Name: PEDRA Users 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 Wireless Standard Frequency Range Data Rate Description IEEE802.11ac/a/b/g/n 2.412GHz~2.484GHz, 5.150MHz~5.850MHz 802.11b: 11Mbps / 802.11a/g: 54Mbps / 802.11n: MCS0~7/ 802.11ac:

MCS0~9 Bluetooth: 1Mbps, 2Mbps and up to 3Mbps EDR WiFi : 802.11b: DSSS (DBPSK, DQPSK, CCK) 802.11a/g: OFDM (BPSK, Modulation QAM, 64-QAM) 802.11n: OFDM (BPSK, QPSK, 16-QAM, 64-QAM) QPSK, 16 802.11ac:

OFDM (BPSK, QPSK, 16-QAM, 64-QAM, 256-QAM) Bluetooth: GFSK, /4 DQPSK, 8DPSK Transmission Power Max. 16dBm Security Antenna WEP, WPA, WPA2 Triple Band Antennas (Detector: internal) Setting Parameters Wireless LAN Setting Parameter Item Description AP ON/OFF Frequency Country Only a wired communication is available to operate for power supply. ON: Turns on Access Point function. The detector can use Detector AP Mode. OFF: Turns off the Access Point function. 2.4: Uses 2.4frequency band 5 : Uses 5 frequency band KR, US, EU Serviceable channels are limited according to the countries you set. Annex. 10 Default value of detector initialization More than just Digital Page 78 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) Network Port : 5050 IP Address : 192.168.0.11 WNetwork SSID : PEDRADXD-5G Key : 12345678 AP AP On/Off : Off Frequency : 5GHz SSID : PEDRA-AP-5G Key : 12345678 Security : WPA2-PSK Detector Parameter Exposure mode : Auto Imaging mode : Portrait Image windows time : 500ms Sleep mode : off More than just Digital Page 79 of 81 Doc. Name: PEDRA Users 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 users 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 low power wireless devices. There is no proof, however, that these low power wireless devices are absolutely safe. Low power wireless devices emit low levels radio frequency energy (RF) in the microwave range while being used. Whereas high levels of RF can produce health effects (by heating tissue), exposure of low-level RF that does not produce heating effects causes no known adverse health effects. Many studies of low-level RF exposures have not found any biological effects. Some studies have suggested that some biological effects might occur, but such findings have not been confirmed by additional research. This device has been tested and found to comply with FCC/IC radiation exposure limits set forth 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 tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. FCC Caution: Any changes or modifications not expressly approved by the party responsible for 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. For product available in the USA/Canada market, only channel 1~11 can be operated. Selection of other channels is not possible. This device is going to be operated in 5.15~5.25GHz frequency range, it is restricted in indoor environment only. More than just Digital Page 80 of 81 Doc. Name: PEDRA Users Manual/Doc. No.: PEDRA-1417M-UM Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1) IMPORTANT NOTE:

FCC Radiation Exposure Statement:

This device meets FCC limits for exposure to radio waves. It is designed not to exceed the limits for exposure to radio waves (radio frequency electromagnetic field) adopted by the 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 operation in conjunction with any other antenna or transmitter. RadiSen Radisen Co., Ltd. Tel. +82-70-7525-2147 Website: http://www.radisentech.com 14F Gongduk B/D, 11, Saechang-ro, Mapo-gu, Seoul, 04168, Republic of Korea 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 Page 81 of 81

The FCC ID shall be permanently affixed in the rear side of the equipment Label photo FCC ID: 2AXRZPEDRA-1417M Page 1 of 1

Ad Hoc Mode and Wi-Fi direct Function Declaration RADISEN CO., LTD, declare that the EUT (Model Name: PEDRA-1417MC) doesnt have Ad Hoc Function and Wi-Fi direct on non-US frequencies and/or on DFS frequencies. In non-

associated mode, that software and associated drives will not initiate any transmission on DFS frequencies. This includes transmissions for beacon ad-hoc peer-to-peer modes. Date: 2020-10-13 FCC ID : 2AXRZPEDRA-1417M To whom it may concern:

We, DATE 13 Day of October 2020 Sincerely, Signature Name: YoungTae Choi Title: RA Manager Company: RADISEN CO., LTD

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road, Columbia, MD 21046 Date: 2020-10-13 RE: Request of confidentiality for FCC ID: 2AXRZPEDRA-1417M To Whom It May Concern:

Pursuant to Sections 0.457 and 0.459 of the Commissions Rules (CFR 47), and Sectio 552 (b)

(4) of the Freedom of Information Act, RADISEN CO., LTD Hereby requests confidentiality and treatment of certain information accompanying this application. The materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of to the Applicant and provide unjustified benefits to its competitors. these matters might be harmful We are also hereby request Short-Term Confidentiality for 180 day after the grant as outlined in Public Notice DA 04-1705. This provision will give RADISEN CO., LTD temporary confidentiality of commercially sensitive information prior to product release. The requested Permanent and Short-Term Confidential exhibits are listed as follows:

PERMANENT AND SHORT-TERM CONFIDENTIAL LIST Exhibit Description PERMANENT SHORT-TERM 1 2 3 4 5 6 7 8 Block Diagram Operational Description Schematics Parts List External Photos Internal Photos Test-Setup Photos Users Manual The Applicant understands that pursuant to Rule 0.457, disclosure of this application and all accompanying documentations, where applicable, will not be made public before the date of the Grant for this application. Sincerely, DATE 2020-10-13 Signature Name: YoungTae Choi Title: RA Manager Company: RADISEN CO., LTD

14F Gongduk B/D, 11, Saechang-ro, Mapo-gu, Seoul, 04168,Republic of Korea RADISEN CO., LTD Federal Communications Commission Authorization and Evaluation Division 1435 Oakland Mills Road Columbia, MD 21046 Date: October 15, 2020 Regarding FCC Application (FCC ID: 2AXRZPEDRA-1417M) This is a description of similarities and differences between the versions of the X-ray Detectors. Variant models are identical to basic model except for Scintillator type. Product Name Digital Flat Panel X-ray Detector Digital Flat Panel X-ray Detector Basic Model Variant model Model Name PEDRA-1417MC Dimension (mm) 384 x 460 x 15 PEDRA-1417MG DET14-MCD1 DET14-MGD1 384 x 460 x 15 TFT Type TFT amorphous Silicon Scintillator type CsI:Tl (Direct) TFT amorphous Silicon CsI:Tl (Direct) GD2O2S:Tb If you need any other information or have any comment, please free to contact me. Signature Name: YoungTae Choi Title: RA Manager

DATE TIMCO ENGINEERING Inc. 849 N.W. State Road 45 P.O. Box 370 Newberry, Florida 32669 Attn: Director of Certification Authority to Act as Agent On our behalf, I appoint Young-Jin, Lee of KES Co.,Ltd. (3701, 40, Simin-daero 365beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14057, Korea) to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the Federal Communications Commissions regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by TIMCO ENGINEERING Inc, still resides with RADISEN CO., LTD (14F Gongduk B/D, 11, Saechang-ro, Mapo-gu, Seoul, 04168,Republic of Korea). I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Dated this 13 Day of October 2020 Agency agreement expiration date:

13, October 2021 By: YoungTae Choi Signature Printed Title: Regulating Affaires Responsible On behalf of :

RADISEN CO., LTD Telephone:

+82-31-8084-9762

RADISEN CO., LTD 14F Gongduk B/D, 11, Saechang-ro, Mapo-gu, Seoul, 04168,Republic of Korea Federal Communications Commission Authorization and Evaluation Division 1435 Oakland Mills Road Columbia, MD 21046 Date: 13 Day of October 2020 Regarding FCC Application (FCC ID: 2AXRZPEDRA-1417M) We, RADISEN CO., LTD, declare that the device does not support channel 12 ~ 13 in 2.4 GHz band. The firmware setting is not accessible by end users and/or unauthorized 3rd parties. Signature:

Name: YoungTae Choi Title: RA Manager Company: RADISEN CO., LTD s