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PRS 500 F

User Manual

5067-0-8002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

30 von 39

6.1.1

Guidelines and Manufacturers declaration – electromagnetic interference (non-life
supporting device)

The radiographic system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the radiographic system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitter) and the radiographic system.

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Summary of Contents for 7067-9-8050L

Page 1: ...d Germany Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 2 0 Issued 2019 07 31 Subject to alterations PRS 500 F Basic diagnostic X ray system Model ID 7067 9 8050L User Manual Ident...

Page 2: ...uthorization of PROTEC s law department Report any violations of this requirement to PROTEC GmbH Co KG 2019 PROTEC GmbH Co KG Oberstenfeld These accompanying documents were created and distributed by...

Page 3: ...sion Hazards 16 2 1 6 Explosion protection 16 2 1 7 Radiation protection 16 2 1 8 Ventilation 16 2 1 9 Interaction with external devices 16 2 1 10 Electromagnetic Environment and the influence of devi...

Page 4: ...ic Calibration only for PROVARIO HF 24 4 11 Exposure automatic 25 5 Safety and Maintenance 26 5 1 Introduction 26 5 2 Cleaning and disinfection 26 5 2 1 Cleaning 26 5 2 2 Disinfection 26 5 3 Check up...

Page 5: ...PRS 500 F User Manual 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 5 von 39 8 1 Symbols 35 8 2 Identification label 36 8 3 Labels 37 8 4 Position symbols and labels 38...

Page 6: ...equipment subsequent to the date of manufacture will be addressed in service updates distributed to the PROTEC Technical Service Organization Document Effectivity Revision No Date List of effective p...

Page 7: ...ng may result in serious or fatal bodily injuries to the operator or those in the area Radiation Warning WARING The component of the equipment described within this Document is part of a system for th...

Page 8: ...e current state of the art residual risk will remain in clinical use These are displayed in the following user manual by application limitations contraindications warnings and precautions The installa...

Page 9: ...ng Collimator Optional components Anti scatter Grid 3 field measuring chamber Dose area product meter system and Different direct X ray systems RAPIXX Serial consisting of DR detector Interface Box an...

Page 10: ...ed for use within rooms with a ceiling height of at least 2 3 meters Wide range of application Small wall distance allows good space utilization Control elements within the command arm well placed and...

Page 11: ...an X ray examination may be For the diagnosis of a bone fracture or bony injuries of the skeletal system or pathological changes of hard tissues To control the bone setting For the diagnosis of luxati...

Page 12: ...e requirements of the European Community Medical Device Directive 93 42 EEC from 06 14 1993 including all current revision standards The declaration of conformity is available directly from PROTEC PRO...

Page 13: ...re described within the user manual must be made with the aid of The technical description for the system by the PROTEC GmbH Co KG customer service department or a PROTEC GmbH Co KG authorized service...

Page 14: ...console and on the swivel arm or wall column there are further descriptions for the symbols in the corresponding manual The lawfully requirements for building regulations for radiographic systems hav...

Page 15: ...wer the connected X ray generator must be shut off 2 1 2 Operating of the radiographic system When having troubles with operating the radiographic system PRS 500 F immediately call the Service of PROT...

Page 16: ...distance from a dot shaped radiation source Double the distance dose triple the distance 1 9 dose Keep the exposure time as short as possible The dosage is directly correlated with the exposure time A...

Page 17: ...or stacked devices should be avoided since it can cause an improper operating mode If there is no other possibility than this the PRS 500 F and other devices should be studied to make sure they work p...

Page 18: ...t of X ray assembly 2 Brake release horizontal movement of X ray system tube support floor stand 3 Brake release movement of X ray tube assembly around the horizontal support arm axis 4 Brake release...

Page 19: ...mbly around the horizontal support arm axis 4 Brake release vertical movement of X ray tube arm and horizontal movement of X ray system tube support floor stand 5 Brake release vertical movement of X...

Page 20: ...he Bucky unit Pos 6 Filter control for selection of additional filtration Pos 7 Collimator adjustment control allows for manual opening and closing of collimator shutter longitudinally to table top Po...

Page 21: ...ke release vertical movement Bucky 2 Switch on light field indicator of collimator Detailed information please find in the enclosed User Manual of the PROVERT 3 8 Control elements and device displays...

Page 22: ...e size of the cassette corresponding detent 13 cm 18 cm 24 cm 30 cm 35 cm 40 cm or 43 cm push the cartridge to the cassette positioner Push the cassette clamps against the cassette and rotate the latc...

Page 23: ...itudinal movement brake of the column by pressing button 2 figure control handle and adjust the source to image receptor distance SID which will be used for the exposure Notice the focus area of the s...

Page 24: ...NAXX 2 4 10 Function of the PRS 500 F 4 10 1 Switching On Off the PRS 500 F Switching on the PRS 500 F happens via the control panel of the Generator The Generator supplies every system component with...

Page 25: ...ual of the generator 4 11 Exposure automatic If the PROS 500 E is operated with an exposure automatic the functionality can be checked like this Place a Phantom or any other weakening object in the ra...

Page 26: ...of the radiographic system PRS 500 F or to the coating of the individual components Clean the outer surfaces of the unit and all painted components using a damp towel and a mild light alkaline cleani...

Page 27: ...oper or omitted maintenance Prior to operation creation of X ray images the operator must ensure that all Safety related mechanisms indicators and or switches described within the user manual are full...

Page 28: ...ication part Optional accessory Patient extending handle optional mounted at the verticalX ray system image receptor stand Part get handled like an application part Patient handle optional mounted at...

Page 29: ...ly with a protective conductor 6 1 Electromagnetic Compatibility EMC after EN 60601 1 2 CAUTION The radiographic system PRS 500 F is as a medical electrical electric device subject to particular preca...

Page 30: ...e non life supporting device The radiographic system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the radiographic...

Page 31: ...PRS 500 F User Manual 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 31 von 39 7 Technical Data 7 1 Dimensions PATIENT PATIENT PATIENT OP...

Page 32: ...User Manual 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 32 von 39 OP Operator 7 2 X ray system table PROGNOST F Table top dimension L x B 2260 mm x 755 mm standard O...

Page 33: ...Technical Description of the Bucky Grid entity 7 4 X ray system tube support floor stand Focal spot vertical travel horizontal X ray beam 294 1882 5mm Focal spot vertical film distance standard PROGN...

Page 34: ...kV and a first half value layer thickness HVLT of 2 7mm Al The cover vertical wall stand is defined as application part The aluminium attenuation equivalent of the cover vertical X ray system image r...

Page 35: ...e This way up Attention consult accompanying documents Refer to user manual CE Mark Manufacturer Trade name Order number Serial number Date of manufacture Classification according to EN 60601 1 Type B...

Page 36: ...devices Do not exceed the maximum indicated weight Do not exceed the maximum indicated weight Horizontal movement of the X ray tube stand Vertical movement of the X ray tube arm Rotation of the X ray...

Page 37: ...weight distributed load for the tabletop Composite fibre tabletop Maximum allowable Patient weight distributed load for the tabletop Carbon tabletop Labels on top of the tabletop and or tubearm Cautio...

Page 38: ...PRS 500 F User Manual 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 38 von 39 8 4 Position symbols and labels Identification label Identification label...

Page 39: ...Dorfwiesen 14 71720 Oberstenfeld Germany 39 von 39 Abbreviations mm Millimetres cm Centimetres lb Pound kg Kilogram C Degree Celsius hPa Hectopascal DIN German Industry Standard EN European Standard C...

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