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Related Manuals for Trixell pixium EZ3
Summary of Contents for Trixell pixium EZ3
- Page 1 Document Identification 1 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 pixium EZ3 In te gra t ion Ma nu a l a nd Ge nera l C aut ions...
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Page 2: Document History
Document Identification 2 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 DOCUMENT HISTORY DOORS Version Date Author Description Baseline November - draft 1 O. Chastel Initial version , 2021 Update information for display October 10 - draft 2 O. -
Page 3: Table Of Contents
Document Identification 3 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 CONTENTS Document History .............................. 2 Contents ................................3 List of Tables ..............................6 List of Figures ..............................7 PRESENTATION ............................8 1.1. INTRODUCTION ..........................8 1.2. GENERAL DESCRIPTION ........................ - Page 4 APPENDIX A: PIXIUM DETECTOR IDENTIFICATION LABELS ............. 39 9.1. Definition of symbols ........................39 9.2. Labels .............................. 40 9.2.1. Labels non CE marked by Trixell ..................... 40 10. APPENDIX B: PIXIUM DETECTOR SUMMARY SHEET ................ 42 10.1. IMAGE GEOMETRY ........................42 10.2. ELECTRO-OPTICAL PERFORMANCES ..................42 10.3.
- Page 5 Document Identification 5 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 11.2.3. Electromagnetic immunity ......................47 11.3. IEC 60601-1-3 standard ........................51 11.4. IEC 60601-2-54 standard ........................ 52 11.5. IEC 60825-1 standard ........................52 11.6. ISO 10993 standard ......................... 52 11.7.
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Page 6: List Of Tables
Document Identification 6 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 LIST OF TABLES Table 1: Reference documents ........................10 Table 2: Acronyms ............................11 Table 3: Connector pin-out for connector unit ....................13 Table 4: Power supply connector pin-out ......................14 Table 5: RJ45 connector pin-out ........................ -
Page 7: List Of Figures
Figure 6: Backup cable connector ........................15 Figure 7: Battery EZ X connection ........................16 Figure 8: Insulation diagram for pixium EZ3 with Cable EZ3 ................17 Figure 9: Insulation diagram for pixium EZ3 with CPT ..................18 Figure 10: Display ............................26 Figure 11: Spatial relationship ......................... -
Page 8: Presentation
EZ3 detector. This manual is intended to help integrators in the installation of a pixium EZ3 detector and its first operation. The figures and data given in this manual shall be considered as indicative and are not contractual. Consult TRIXELL for additional information. -
Page 9: Delivery
one battery charger (Charger EZ X), accompanying documentation. Note that each customer may have a specific configuration for delivery. The standard pixium EZ3 delivery does not include in particular: an external power supply (part of the customer System), an Ethernet insulator, IDENTIFICATION 1.5. -
Page 10: Reference Documents
UL : Combined UL/CSA certification (C-UL) label CSA : Combined UL/CSA certification (C-UL) label System integrator is in charge of CE labeling for the overall equipment. However, TRIXELL provides a compliance certificate for essential requirements relative to 2017/745/EEC regulation. -
Page 11: Definition, Acronyms, Abreviation
Institute of Electrical and Electronics Engineers International Standard Organization Industrial, Scientific and Medical Light Emitting Diode OFDM Orthogonal Frequency-Division Multiplexing Radio Frequency SIRN Software Integration Release Note To Be Defined TDLP Trixell Detector Link Protocol Wireless Power Transfer Table 2: Acronyms... -
Page 12: Installation
Constraints: pixium EZ3 is qualified to be exposed to variations of accelerations refer to Appendix B environmental conditions section. The detector can’t be used with non-natural variations of pressure. Tightness: pixium EZ3 has a degree of protection against ingress of water of IP 67 according to IEC 60529. -
Page 13: Connectics
Document Identification 13 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 CONNECTICS 2.2.2. Connector unit 2.2.2.1. Figure 3: Backup cable connector Pin number Signal GND_SHIELD GND_SHIELD GND_SHIELD TXRXP_B TXRXM_A P12V P12V TXRXM_B TXRXP_A GND_SHIELD GND_SHIELD GND_SHIELD GND_SHIELD GND_SHIELD TXRXP_C TXRXM_D... -
Page 14: Cable Ez3: Tdlp Link
Document Identification 14 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 Figure 4: Power supply connector Pin number Signal P12V Table 4: Power supply connector pin-out - CAUTION - Power supply polarity inversion or out of range power supply (including a missing power supply) may harm the detector. -
Page 15: Cable Ez3: Detector Connector
Document Identification 15 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 Pin number Signal TXRXP_A TXRXM_A TXRXP_B TXRXP_C TXRXM_C TXRXM_B TXRXP_D TXRXM_D Table 5: RJ45 connector pin-out Cable EZ3: Detector connector 2.2.2.4. A connector is accessible on the left side of the detector housing, in order to connect a cable from the System. The purpose is to recharge the battery when discharged and to allow going on with image acquisition. -
Page 16: Battery Ez X: Cpt Connector
GND_SHIELD GND_SHIELD Table 6: Connector pin-out for backup cable Note that Cable EZ is compatible with pixium EZ3. Nevertheless, the data rate will be reduced to 100Mb/s. Battery EZ X: CPT connector 2.2.2.5. The connection to the pixium EZ3 through the battery’s CPT are as follow:... -
Page 17: Insulation Diagram
INSULATION DIAGRAM 2.2.3. Protective earth 2.2.3.1. pixium EZ3 and Charger EZ X do not contain any PE. Safe design: The system-earthing diagram must be in accordance with document [EIS] (galvanic separation of electrical circuits) and recalled hereafter. - CAUTION - Connector and cable shields must not be used as protective earth connection. -
Page 18: Table 8: Insulation Safety Distances
Detector unit Main board Carbon enclosure System + 12 V SAPM 240V Detector supply unit Protective earth Figure 9: Insulation diagram for pixium EZ3 with CPT Reference Creepage Location Protection Air clearance Test voltage voltage distance 8 mm 5 mm... -
Page 19: X-Ray Generator Connection
X-Ray source: The emission of the ionizing radiation is controlled by the system manufacturer. pixium EZ3 is not approved to control the emitted X-ray dose. If the pixium EZ3 is used as a "sub-assembly" in an X-ray dose loop, the corresponding risk management has to be done at the radiological system level. -
Page 20: Detector Settings
PROTECTION AGAINST MECHANICAL DAMAGE IN BUCKY TRAY 2.2.9. pixium EZ3 is compatible with ISO 4090 film cassette standard. In order to avoid damage of the plastic detector cover in standard bucky trays, TRIXELL recommends to protect with thin tape (like kapton) any sharp... -
Page 21: First Operation
Document Identification 21 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 FIRST OPERATION SWITCH ON 3.1. There is no switch to be activated to start operating the detector, provided the battery is connected and charged, or an external power (cable, CPT or WPT) is used. While switched on (during boot sequence), status LED (refer to §3.3.1) is blinking slow in orange colour. -
Page 22: Detector Status Led
Document Identification 22 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 DETECTOR STATUS LED 3.3.1. Symbol: LED color / status Meaning OPERATING state and ONLINE OFFLINE LISTEN state OFF state ERROR state DOWNLOAD state Buffer full (not enough space for one acquisition in 1x1 mode) in case storage is enabled Switch on Start of boot (after wake-up) :... -
Page 23: Table 10: Detector Status
Document Identification 23 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 LED color / status Meaning When the detector has finished boot sequence, it arrives in error or operating state (see above) Switch off (going to OFF state) when requested by message or by time-out then red flash light on the 3 LEDs then OFF... -
Page 24: Wifi Led
Document Identification 24 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 WIFI LED 3.3.2. Symbol: LED color / status Meaning Wi-Fi available (detector connected to an Access Point) Wi-Fi not used (Wi-Fi switched off by software) Wi-Fi not ready (detector not connected to an Access Point) Table 11: Wifi status In Listen, Download, Error states, same behaviour as in Operating state. -
Page 25: Battery Led
Document Identification 25 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 BATTERY LED 3.3.3. Symbol: LED color / status Meaning Battery capacity between 100% and Low_level_trigger_2 Battery capacity between Low_level_trigger_2 and Low_level_trigger_1 Battery capacity below Low_level_trigger_1 No battery Table 12: Battery status The battery LED follows the previous rules independently of the cable voltage. -
Page 26: Display
Code Type Document Version SIF-F-003 63121445 DISPLAY 3.3.4. pixium EZ3 equipped with full connector unit owns a LCD display on the edge of the detector used for provide information to the end user: Figure 10: Display Symbol: Indicators Meaning Gives a visual indication of the remaining battery level and if the battery is being charged. - Page 27 The table mode is given in a separate document called SIRN provided to system integrator with each software version. Please refer to the SIRN before integrating a new software. - CAUTION - Modes that are not described in the SIRN are TRIXELL reserved.
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Page 28: Spatial Relationship
Document Identification 28 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 SPATIAL RELATIONSHIP 3.5.2. The relationship between the physical detectors and the corresopnding images issued from an acquisition are as follow: Bottom Bottom Bottom Mapix side Mapix side x (image) x (image) y (image) -
Page 29: Cautions And Recommendations
Radiological System. Biocompatibility: The sensitive side of pixium EZ3 is designed to be safe in case of short-term contact with damaged skin (less than 24 hours). Nevertheless, if such case occurs, the FE will be preferably wrapped with sterile plastic bag. -
Page 30: Conditions Of Acceptability From Sharms
[COA_RMS_0220]: The detector shall only be used during medical examination, except if a specific use case is agreed between TRIXELL and a system integrator. [COA_RMS_0230]: To system integrator: To prevent overheat, TRIXELL recommends to the system integrator to manage internal temperature in order to prevent overheat, by reading temperature through software or by a validated mean. -
Page 31: Cybersecurity
(i.e.: changing the battery) CYBERSECURITY 4.2. Pixium detector was developed taking into account Cyber Security constraints. The methodology for Trixell risk analysis is based on EBIOS and is compliant to ISO27K5. Note: Pixium EZ 3 detectors exists in two different SW versions: ... -
Page 32: Cables And Connectors
The system integrator must take care with the kind of cables used to connect the pixium to the system : TRIXELL recommends using a shielded power supply cable. The shielding must be properly connected to the dedicated connector metallic body in order to insure a good electrical connection. The EMC conformity of the detector was checked with 360°... -
Page 33: Warm-Up Time From A Cold Start
For maintenance please refer to system integrator maintenance manual. SOFTWARE USE INFORMATIONS 4.9. When detector is powered on, the system must check the result of the pixium EZ3 internal self-tests. During operation, TRIXELL recommends the system to check: the header of every image sent by the detector, ... -
Page 34: Troubleshooting
“Not Available” status, please contact Trixell field service. If detector is not operational after reboot, Trixell recommends to retrieve error buffer through software command to get more information about last error. To do this, a communication link with system is mandatory... -
Page 35: Cleaning And Disinfections Instructions
Document Identification 35 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 CLEANING AND DISINFECTIONS INSTRUCTIONS The detector housing can be cleaned using a sweet towel, with respect to ESD safety conditions. Note that the detector has a degree of protection against ingress of water of IP 67 according to IEC 60529. The sterilization, disinfecting, and cleaning conditions are defined by the customer in the context of the System use. - Page 36 Document Identification 36 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 #F19 PDI Sani-Cloth Super #F20 PDI Sani-Cloth Bleach #F21 Clorox Bleach germicidal wipes #F22 Diversey - sealed air Accel Five TB Wipes Battery EZ X is considered as a part of the Front End, so same list of liquids applies.
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Page 37: Eco-Design
BATTERY 7.2.1. The end user must be clearly informed that battery packs Battery EZ X used in pixium EZ3 contain hazardous substances for the environment and must take all preventive actions to manage the battery end of life (recycling plan). -
Page 38: Manufacturer
Document Identification 38 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 MANUFACTURER pixium EZ3 is manufactured by: TRIXELL 460, rue du Pommarin 38430 Moirans FRANCE Phone : (+33)-4-76-57-41-00 Fax :(+33)-4-76-57-40-48 Contact your local representative for additional information. -
Page 39: Appendix A: Pixium Detector Identification Labels
Document Identification 39 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 APPENDIX A: PIXIUM DETECTOR IDENTIFICATION LABELS DEFINITION OF SYMBOLS 9.1. Symbol Signification Caution, consult accompanying documents Consult accompanying documents Direct current RF equipment Applied part Maximum allowed weight Degree of protection provided by enclosure Detector status Battery charge status... -
Page 40: Labels
Date of manufacture Serial number Catalog number Table 15: Labels LABELS 9.2. LABELS NON CE MARKED BY TRIXELL 9.2.1. The labels presented below are not contractual and done for information Figure 12: Identification label Figure 13: pixium 2430 EZ3 main label... -
Page 41: Figure 14: Pixium 3543 Ez3 Main Label
Document Identification 41 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 Figure 14: pixium 3543 EZ3 main label Figure 15: pixium 4343 EZ3 main label Note that empty zone is reserved for RF certificate ID... -
Page 42: Appendix B: Pixium Detector Summary Sheet
Document Identification 42 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 APPENDIX B: PIXIUM DETECTOR SUMMARY SHEET 10.1. IMAGE GEOMETRY Transmitted image size: Specification Product Description Value Unit [PTS-REQ-0740] 2430 Width: 2336 PTS_transmitted_im 3543 Width: 3520 4343 Width: 4320 [PTS-REQ-0750]... -
Page 43: Mechanical Interface
Document Identification 43 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 Input current on connector unit: Specification Product Description Value Unit [EIS-REQ-0040] Typical and maximum sustained current in EIS_pwr_input_curr mode 1, gain 4, image readout. ent_A [EIS-REQ-0070] Maximum peak current (at power ON or EIS_pwr_input_inru during image acquisition) shall be lower than:... -
Page 44: Humidity
Document Identification 44 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 Specification Product Description Value Unit [PTS-REQ-1640] The functional and performance operating 1000 1100 mbar PTS_pressure_rang conditions for air pressure are: e_operational [PTS-REQ-1650] The reference restrictions for distance to mbar PTS_dist_calib_pre calibration conditions for air pressure are:... -
Page 45: Appendix D: Standards
63121445 APPENDIX D: STANDARDS It is important to refer to the relevant checklist to analyze the answer made by TRIXELL to the various clauses of the standards. 11.1. IEC 60601-1 ED 3.2 / ANSI AAMI 60601-1 / CAN/CSA C22.2 N°60601-1 STANDARDS The detector is compliant with following standards. -
Page 46: Iec 60601-1-2 Standard
EZ3 is intended to be used in both domestic and professional healthcare facility environment (see IEC 60601-1-11 for definition). The customer or the user of the pixium EZ3 should assure that it is used in the corresponding electromagnetic environment specified below. -
Page 47: Electromagnetic Immunity
EZ3 is intended to be used in both domestic and professional healthcare facility environment (see IEC 60601-1-11 for definition). The customer or the user of the pixium EZ3 should assure that it is used in the corresponding electromagnetic environment specified below. - Page 48 Document Identification 48 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 Immunity test IEC 60601-1-2 ed 4.1 Compliance level Electromagnetic environment - test level Guidance Spot frequencies in Spot frequencies in Recommended separation accordance with IEC accordance with IEC distance: 60601-1-2 table 9 60601-1-2 table 9 with...
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Page 49: Table 18: Emc Immunity Guideline
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If abnormal performance is observed, additional measures may be necessary, such as relocating pixium EZ3 or using a shielded location with a higher RF shielding effectiveness and filter attenuation. - Page 50 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 pixium EZ3, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”...
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Page 51: Iec 60601-1-3 Standard
System manufacturer, if compliance is demanded at marking and documents system level. Marking on the outside of the equipment or parts of equipment 5.1.1 General TRIXELL 5.1.2 Marking requirements in System manufacturer, if compliance is demanded at subclauses system level. Accompanying documents 5.2.1... -
Page 52: Iec 60601-2-54 Standard
Table 21: IEC 60825-1 guideline 11.6. ISO 10993 STANDARD pixium EZ3 complies with ISO 10993-1. The sensitive side is suitable to be in contact with skin, mucosal membrane and breached or compromised surface for a limited period (< 24 hours). -
Page 53: Fda Cfr21 §I - Part 1020
Not applicable 1020.20 Cold-cathode gas discharge Not applicable 1020.30 Diagnostic X-ray systems and their major components a) Applicability TRIXELL b) Definitions TRIXELL c) Manufacturer’s responsibility System manufacturer, if compliance is demanded at system level. d) Assembler’s responsibility System manufacturer, if compliance is demanded at system level. -
Page 54: Table 23: Fda Guideline
Document number Code Type Document Version SIF-F-003 63121445 Clause Title Compliance ensured by o) Battery charge indicator TRIXELL p) [Reserved] q) Modification of certified System manufacturer, if compliance is demanded at diagnostic X-ray components and system level. systems 1020.31 Radiographic equipment System manufacturer, if compliance is demanded at system level. -
Page 55: Rf Certificates
It is the responsibility to system integrator and/or hospital maintenance staff to properly configure the embedded WiFi module with respect to the country where pixium EZ3 detector is installed. Note that the WiFi functionalities can only be used in the countries listed hereafter. For other countries, pixium EZ3 family detectors must be used in wired configuration and the WiFi modules switched off. - Page 56 Hierbij verklaart TRIXELL dat het toestel pixium EZ3 in overeenstemming is met de essentiële eisen en de andere relevante bepalingen van richtlijn 2014/53/UE. Bij deze verklaart TRIXELL dat deze pixium EZ3 voldoet aan de essentiële eisen en aan de overige relevante bepalingen van Richtlijn 2014/53/UE.
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Page 57: Fcc Rules (U.s.a.)
Document Identification 57 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 EU type examination certificate: RED_771 FCC RULES (U.S.A.) 11.9.2. 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. -
Page 58: Hong-Kong
à l’intérieur afin de réduire les risques de brouillage préjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux. IC: 7392A-EZ3NFC contains IC: 7392A-NFB265AXIBT HONG-KONG 11.9.4. There is no specific RF certificate for pixium EZ3 since it is already certified for Europe and United States... -
Page 59: Cmiit (China)
11.9.6. For countries not listed here before, the system integrator must disable the RF functionalities (see appropriate command in document [SIS]). In such configuration, pixium EZ3 is compliant with CISPR11 class B limits and can be considered as non-radio product. -
Page 60: Appendix E: Rf Communication
SIF-F-003 63121445 APPENDIX E: RF COMMUNICATION Since pixium EZ3 can be used without any cable, it exchanges data (as commands, synchronization images…) thanks to radio frequency modules which are able to operate in the ranges 2.412GHz…2.484GHz, 5.180GHz…5.320GHz, 5.500GHz…5.700GHz and 5.725GHz…5.825GHz. -
Page 61: Eirp
Document Identification 61 / 61 doors://zvedoors01:36681/?version=2&prodID=0&view=00000002&urn=urn:telelogic::1-4875b3e076430ad2-M-00006a87 Document number Code Type Document Version SIF-F-003 63121445 12.3. EIRP Measured EIRP (according to EN 300 328 v2.2.2 and EN 301 893 v2.1.1) are provided in [EUM]. END OF DOCUMENT...
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