Protec 7021-8-9571 Instructions For Use Manual Download Page 1

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PROTEC GmbH & Co. KG

In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Telephone: +49 (0) 7062/92 55-0 E-Mail: [email protected]

Version: 4.0

Issued: 2022-01-20

Subject to alterations

Polydoros RFX

High-voltage generator with Mini Console

Model/ID: 7021-8-9571

7021-8-9671
7021-8-9871

Manufactured by Siemens Healthcare GmbH

Material number: 11011021; 11011590

Instructions for use

Ident. Nr. 5021-0-1002

Summary of Contents for 7021-8-9571

Page 1: ...Mail protec protec med com Version 4 0 Issued 2022 01 20 Subject to alterations Polydoros RFX High voltage generator with Mini Console Model ID 7021 8 9571 7021 8 9671 7021 8 9871 Manufactured by Siem...

Page 2: ...r other use is prohibited without the express written authorization of PROTEC s law department Report any violations of this requirement to PROTEC GmbH Co KG 2021 PROTEC GmbH Co KG Oberstenfeld These...

Page 3: ...Information 11 1 1 2 1 Purpose of this Document 11 1 1 2 2 Text Layout 11 1 1 2 3 Illustrations 12 1 1 2 4 Value Statement 13 1 1 3 Acronyms and Abbreviations 13 1 1 4 Laws Standards and Regulations...

Page 4: ...g Label for Logistic Numbers 36 1 2 9 6 Description of the Product Packing Label for Shippable Configuration Elements 37 1 2 9 6 1 High voltage generator 37 1 2 9 6 2 Mini Console 38 1 2 9 7 Label Pos...

Page 5: ...58 2 4 1 Transport and Storage Conditions 58 2 4 1 1 High voltage generator 58 2 4 1 2 Mini Console 58 2 4 2 Operating Conditions 58 2 4 2 1 High voltage generator 58 2 4 2 2 Mini Console 58 2 5 Clas...

Page 6: ...d 17 Chapter 1 2 3 2 Installation Hazards Improper lifting box changed 18 Chapter 1 2 3 3 Operating Hazards Accessible voltages box changed 19 Chapter 1 2 3 3 Operating Hazards Wrong power supply cord...

Page 7: ...3 Safety Instructions first sentence updated 17 Chapter 1 2 3 1 Unpacking Hazards Improper unpacking changed from Notice to Warning 32 Chapter 1 2 9 1 High voltage generator typing errors corrected 4...

Page 8: ...he radiographic parameters are to be set by the system via the digital interface The intended medical and patient application must be determined and described by the system manufacturer 1 1 1 1 High v...

Page 9: ...ry HV generators are integral components of diagnostic X ray systems They are used to regulate incoming voltage and current to provide an X ray tube assembly with the power needed to produce an X ray...

Page 10: ...from newborn to geriatric The patient population might need to be restricted on system level as result of the integration of the HV generator into a diagnostic X ray system by the system integrator 1...

Page 11: ...2 Text Layout Note NOTE Example of a Note A note emphasizes important information without there being any direct danger and helps you to operate the product properly and to avoid errors It also provi...

Page 12: ...or 60 V DC Radio frequency Warning of non ionizing radiation Hot surfaces Warning of hot surfaces Type B applied part Power ON button Power OFF button Radiation LED Exposure button 1 1 2 3 Illustratio...

Page 13: ...trostatic Discharge EU European Union FTT Fault Tolerance Time GCB Generator Control Board HV High Voltage HVT High Voltage Tank IEC International Electrotechnical Commission INV Inverter LED Light Em...

Page 14: ...20 Performance standard for ionizing radiation emitting products USA 21 CFR Part 820 Quality System Regulation USA International Electrotechnical Commission IEC the following standards are considered...

Page 15: ...ment to medical devices 21 CFR Part 1020 Performance standard for ionizing radiation emitting products USA 21 CFR Part 820 Quality System Regulation USA International Electrotechnical Commission IEC t...

Page 16: ...t accept responsibility for the safety features and for the reliability and performance of the equipment as the manufacturer assembler installer or importer if installation readjustments or repairs ar...

Page 17: ...orm this kind of work 1 2 3 Safety lnstructions The generator and the Mini Console may only be operated in compliance with all safety instructions in this document The system owner is responsible for...

Page 18: ...nstallation of protective earth may cause serious physical injury or death The protective earth connection shall be tested after the installation of the generator 1 2 3 3 Operating Hazards WARNING Acc...

Page 19: ...ge from generator line input After switch off all components of the generator and the XTA are still powered After disconnect from mains behind fuses F1 F3 all components of the generator and the XTA a...

Page 20: ...Polydoros RFX Instructions for use 5021 0 1002 20 von 64 NOTICE Wrong power supply cords When setting up the generator Only use power supply cords that meet the specifications...

Page 21: ...ning the console use only a water damp cloth Dry it with a soft cotton cloth Remove any contamination such as contrast medium stains immediately Avoid scratches and shocks Remove drops of water immedi...

Page 22: ...ntennas should be used no closer than 30 cm 12 inches to any part of the Polydoros RFX or connected components including cables specified by the manufacturer Otherwise degradation of the performance o...

Page 23: ...ss B The Polydoros RFX is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domest...

Page 24: ...ronment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle at 0 45 90 135 180 225 270 and 315 Not applicable for products with 3 phase AC...

Page 25: ...AM 150 kHz to 80 MHz ISM frequencies 3 Vrms 150 kHz to 80 MHz ISM frequencies Radiated RF EM fields IEC 61000 4 3 3 V m 1 kHz 80 AM 80 MHz to 2 7 GHz 3 V m see next table NOTE These guidelines may not...

Page 26: ...430 470 GMRS 460 FRS 480 FM 5 kHz deviation 1 kHz sine 28 710 745 780 704 787 LTE Band 13 17 Pulse modulation 217 Hz 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse mod...

Page 27: ...o the IEC 60601 1 complies with the requirements of the valid version of the IEC 60601 standard series and the relevant national deviations to this standard If in doubt consult your technical service...

Page 28: ...n the Mini Console according to initial settings Checks during Exposure Perform a visual inspection of the indicators and control lights on the Mini Console Check the indicator for radiation It may li...

Page 29: ...erator Label Meaning Identification label Polydoros RFX Identification label H T Logistic material number label Polydoros RFX Low Power Logistic material number label Polydoros RFX High Power Identifi...

Page 30: ...ber High Power Product packing label Shippable configuration elements High power upgrade Product packing label Shippable configuration elements AMC Caution Risk of electric shock when panel is removed...

Page 31: ...abel Meaning Revision status label Revision status AMC Connection label Transport and storage environmental conditions Mechanically sensitive tighten EPRC label Order of assembly Maximum load Warning...

Page 32: ...mechanical hazards only in accordance with ANSI AAMI ES60601 1 2005 AMD 1 2012 CAN CSA C22 2 No 60601 1 2014 IEC 60601 1 3 2013 CSA CAN CSA C22 2 No 60601 1 3 09 2014 AMD1 2015 IEC 60601 1 6 2013 CAN...

Page 33: ...5021 0 1002 33 von 64 1 2 9 2 Mini Console Label Meaning Identification label Revision label Radiation emission warning label EPRC label Packaging label Transport and storage environmental conditions...

Page 34: ...Identification Label 1 2 9 3 1 High voltage generator 1 Product name 2 Global trade identification number 3 Model number 4 Country of origin code 5 Serial number 6 Identifier of selected system compon...

Page 35: ...ni Console 1 Product name 2 Global trade identification number 3 Model number 4 Country of origin code 5 Serial number 6 Legal manufacturer 1 2 9 4 Description of the Logistic Material Number Label 1...

Page 36: ...021 0 1002 36 von 64 1 2 9 5 Description of the Product Packing Label for Logistic Numbers 1 Product name 2 Usage 3 Global trade identification number 4 Model number 5 Country of origin code 6 Legal m...

Page 37: ...on of the Product Packing Label for Shippable Configuration Elements 1 2 9 6 1 High voltage generator 1 Product name 2 Global trade identification number 3 Model number 4 Country of origin code 5 Seri...

Page 38: ...for use 5021 0 1002 38 von 64 1 2 9 6 2 Mini Console 1 Product name 2 Global trade identification number 3 Model number 4 Country of origin code 5 Serial number 6 Revision number 7 Legal manufacturer...

Page 39: ...1 Location of the Labels on the Polydoros RFX 1 Identification label Polydoros RFX 2 Identification label logistic numbers 3 Shippable configuration elements high power 4 EPRC 5 UL 6 Dangerous Voltage...

Page 40: ...ructions for use 5021 0 1002 40 von 64 1 Identification labels logistic numbers high power revision status RFX 2 Electric shock waiting time 3 Fuse replacement 4 Electrical connection 5 Disconnection...

Page 41: ...64 1 2 9 7 2 Location of the Labels on the High voltage Tank 1 Service part identification 2 Identification label 3 Revision status 4 Safety waiting time 5 Order of assembly 6 Mechanically tighten 7...

Page 42: ...Polydoros RFX Instructions for use 5021 0 1002 42 von 64 1 2 9 7 3 Location of the Labels on the AMC Box 1 Identification label AMC 2 Revision status AMC 3 Identification label AMC box...

Page 43: ...21 U S Code of Federal Regulations 1020 30 j the control panels of X ray systems brought into U S interstate commerce shall bear the following warning statement legible and accessible to view Warning...

Page 44: ...ured Disposal as domestic or industrial waste is forbidden In the interest of complying with legal requirements concerning the environmental compatibility of our products protection of natural resourc...

Page 45: ...hase PE N not needed 50 60 Hz 3 Hz 400V 440V 480 V 2 1 2 Internal Line Resistance Line voltage Maximum internal line resistance1 55 kW 65 kW 80 kW 380 V 0 15 0 15 0 10 400V 0 17 0 17 0 11 440V 0 20 0...

Page 46: ...urrent time product 0 5 mAs to 800 mAs 55 65 kW 0 5 mAs to 1000 mAs 80 kW Tolerances kV accuracy mA accuracy ms accuracy mAs accuracy IEC 60601 2 54 5 5 0 1 mA 10 1 ms 10 0 2 mAs X ray techniques oper...

Page 47: ...5 kV 440 mA 520 mA 640 mA 150 kV 366 mA 433 mA 533 mA 1 For large focus and 100 ms exposure time Maximum applicable values for the XTA may differ Output power1 800 mA 100 kV 100 ms 80 kW 650 mA 100 kV...

Page 48: ...red on safety feature in duplicate 2 LEDs Exposure button Releasing X ray 2 stages pre main contact Radiation LED yellow Lights up if radiation is triggered Radiation buzzer The buzzer drive signal is...

Page 49: ...fferent slide in module configurations Low Power configuration High Power configuration 1 Mains rectifier and capacitor MRC_1 MRC_1 2 Resonant circuit extension RCE_2 RCE_1 3 Inverter lNV_1 lNV_1 4 In...

Page 50: ...mm1 Height 602 mm 374 mm Depth2 442 mm 442 mm Weight Generator 78kg 78kg 1 External cooling fan not considered 2 Mains inlet not included With consideration of the mains inlet the depth is 496 mm Min...

Page 51: ...Polydoros RFX Instructions for use 5021 0 1002 51 von 64 2 2 4 Control and Display Elements 1 Power LED green 2 Power ON button 3 Power OFF button 4 Radiation LED yellow 5 Exposure button...

Page 52: ...5 Interfaces of the Mini Console Interface Type 1 Generator X1 HD D Sub DE 15 male 2 Hand switch X2 RJ 10 4P4C NOTE The X1 cable supplied with the Mini Console must be used to connect the generator Th...

Page 53: ...Polydoros RFX Instructions for use 5021 0 1002 53 von 64 2 3 Dimensional Drawings 2 3 1 Mini Console Dimensions...

Page 54: ...Polydoros RFX Instructions for use 5021 0 1002 54 von 64 2 3 2 Mounting Hole Dimensions...

Page 55: ...structions for use 5021 0 1002 55 von 64 2 3 3 Vertical Design Dimensions of the generator cabinet vertical design Dimensions of the generator cabinet vertical design top view 1 Mains inlet 2 Air outl...

Page 56: ...ns for use 5021 0 1002 56 von 64 2 3 4 Horizontal Design Dimensions of the generator cabinet horizontal design Dimensions of the generator cabinet horizontal design top view 1 External cooling fan 2 A...

Page 57: ...up the generator It is not allowed to close or cover up the ventilation slots The bending radius of the used mains supply lines shall be considered e g min 185 mm for 5 x 35 mm2 For the horizontal ge...

Page 58: ...condensation Admissible barometric pressure 700 hPa to 1060 hPa 2 4 2 Operating Conditions 2 4 2 1 High voltage generator NOTE The Polydoros RFX must not be operated below an ambient temperature of 1...

Page 59: ...ertificated Transport class IEC 60721 3 2 2M4 Overvoltage category IEC 60601 1 ll 2500 Vpeak Material group Comparative tracking index CTI EN60601 1 2006 lll b 100 CTI 175 Pollution degree IEC 60601 1...

Page 60: ...4 3 Console Operation 3 1 Switching On Off the Generator Press the ON button the generator is switched on Press the OFF button the generator is switched off NOTE The power on status of the generator i...

Page 61: ...s the exposure button down to the first pressure point and hold it approx 1 sec The rotating anode is accelerated to nominal speed The required filament current is set NOTE After warming up the filame...

Page 62: ...or Control 4 2 Parameters of the Software X ray Generator Control The user can activate different patient anatomies with these buttons child thin normal and thick The following functions can be used i...

Page 63: ...kV mA ms Focus small Focus large Measurement chamber left Measurement chamber middle Measurement chamber right Tube energy low Tube energy normal Density Increase parameter Increases a parameter e g k...

Page 64: ...elftest not allowed Reset error and restart generator 0x222 546 The door contact is open during selftest 0x225 549 The requested tube current is too high Check exposure settings 0x226 550 The requeste...

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