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Protec 7069-9-8050L Скачать руководство пользователя страница 30

PRS 500 E

User Manual

5069-0-8002

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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Содержание 7069-9-8050L

Страница 1: ...ld Germany Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 2 0 Issued 2019 08 27 Subject to alterations PRS 500 E Basic diagnostic X ray system Model ID 7069 9 8050L User Manual Ident Nr 5069 0 8002 PRS 500 E in analogue base configuration ...

Страница 2: ...authorization 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 the documentation department Comments and questions about the documentation please contact PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Deutschland Phone 49 7062 92 55 0 Fax 49 7062 92 5...

Страница 3: ...ision 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 devices 17 3 Control elements and device displays 18 3 1 Control elements and device displays PROGNOST E 18 3 2 Control elements and device displays PROGNOST SH 18 3 2 1 Operating unit PROGNOST SH Standa...

Страница 4: ...0 2 Dosimetric 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 and maintenance 27 5 3 1 Daily Controls prior to or during the unit operation 27 5 3 2 Regular controls 27 5 3 3 Only original spare parts are to be used in situations requiring component ...

Страница 5: ...User Manual 5069 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 5 von 39 8 1 Symbols 35 8 2 Identification label 37 8 3 Labels 37 8 4 Position symbols and labels 38 8 5 Abbreviations 39 ...

Страница 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 pages Comments 1 0 2019 05 14 all New created replaces document 5089 0 0002_V5 2 0 2019 08 27 Cap 1 2 6 1 1 7 1 8 1 8 2 8 4 GMDN terms updated Changed optional accessories and images dimension EMC table...

Страница 7: ...ing 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 the intended generation of X rays for medical diagnosis X rays generate a potential risk for both patients and operators For this reason the application of X rays for a given medical purpose must aim a...

Страница 8: ...he 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 installation and service of equipment described herein is to be performed by authorized qualified PROTEC GmbH Co KG Customers Assemblers and other Customers not employed by nor directly affiliated with PROTE...

Страница 9: ...ly with housing Collimator Optional components Anti scatter grid 3 field measuring chamber Dose area product meter system and Different DR detector systems RAPIXX sets consisting of DR detector Interface Box and Software Optional Accessories The PRS 500 E can be equipment or customized with the following accessories Patient extending handle Compression band Mattress Short hand grip Short hand grip...

Страница 10: ...ling free column stand intended 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 easy to activate Reproducible positioning of the X ray tube assembly positions resulting from rotation around the axis of the carrying arm through angle indicator Vertica...

Страница 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 luxations and ligament ruptures of the locomotor system For the diagnosis of degenerative inflammatory traumatic and tumorous diseases and changes of the locomotor system For diagnostic of malformations an...

Страница 12: ...he 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 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Telephone 49 0 7062 92 55 0 Fax 49 0 7062 92 55 60 E Mail protec protec med com Internet www protec med com ...

Страница 13: ...are 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 technician NOTE Every delivered manual has to be read and the safety notes have to be observed NOTE After installation the commissioning have to be recorded with the PROTEC acceptance protocol NOTE ...

Страница 14: ...g 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 have to be fulfilled The radiographic system has to be checked according to the local law and also accepted by the responsible office CAUTION If the wrong SID is in use for exposures personal injuries f...

Страница 15: ...ower 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 E immediately call the Service of PROTEC or an authorized service and stop the using of the system 2 1 3 Operating type The PRS 500 E is not designated for continuous use Duty Cycle S3 15 maximum continuous operation of 1 5 minutes 2 1 4...

Страница 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 half exposure time results in a radiation dose half that of a full exposure This is especially pertinent with fluoroscopy as X ray images have predetermined mAs Utilize shielding and protective clot...

Страница 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 E and other devices should be studied to make sure they work proper NOTE The characteristics of this device as determined by emissions allow its use in the industrial sector and in animal clinics CISPR Class A When used in residential areas for which Class B is...

Страница 18: ...nt 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 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 ray tube arm and horizontal movement of X ray system tube s...

Страница 19: ...embly 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 ray tube arm and horizontal movement of X ray system tube support floor stand 6 Brake release movement of X ray tube assembly around the horizontal support arm axis 7 Brake release vertical movement ...

Страница 20: ...the 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 Pos 8 Scales indicate the opening of collimator shutters longitudinally to table top Pos 9 Collimator light switch turns on collimator light Pos 10 Measuring tape Detailed information please find in th...

Страница 21: ...rake 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 of RAPIXX system Detailed information please find in the enclosed User Manual of the RAPIXX system 3 9 Control elements and device displays of CONAXX 2 Detailed information please find in the enclos...

Страница 22: ...or by engaging the cassette positioner in the 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 latch into the locked position Push the cassette tray fully into the Bucky unit 4 1 1 4 Adjusting the focus film distance FFD Set the X ray unit with a tape mea...

Страница 23: ...f the source to image receptor distance SID Release the longitudinal 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 scanning unit Bucky and Grid entity Those settings have to be done with the measuring tape inside the collimator or with the markings on the ...

Страница 24: ... Detailed information please find in the enclosed User Manual 4 9 Operation Software Detailed information please find in the enclosed installation and User Manual CONAXX 2 4 10 Function of the PRS 500 E 4 10 1 Switching On Off the PRS 500 E Switching on the PRS 500 E happens via the control panel of the Generator The Generator supplies every system component with power On the Generator and the con...

Страница 25: ...ened in the Service program Menu Settings Setup kV Control Dosimetric Calibration VENUS 50R detailed information please find in the enclosed User Manual 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 radiation way Choose a measuring chamber and expose I...

Страница 26: ...e of the radiographic system PRS 500 E 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 cleaning agent e g RBS Neutral T Dry the components off following cleaning Chrome components should be cleaned by being wiped down with a dry woolen cloth 5 2 2 Disinfection Disinfection must be performed ...

Страница 27: ...roper 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 fully functional and that the unit is overall operationally ready See Technical Description off the system and off all integral components Only original spare parts are to be used in situations requiring...

Страница 28: ...lication part Optional accessory Patient extending handle optional mounted at the vertical X ray system image receptor stand Part get handled like an application part Patient handle optional mounted at the X ray system table Part get handled like an application part Compression Band optional Part get handled like an application part Mattress optional Part get handled like an application part 5 3 8...

Страница 29: ... supply with a protective conductor 6 1 Electromagnetic Compatibility EMC after EN 60601 1 2 CAUTION The radiographic system PRS 500 E is as a medical electrical electric device subject to particular precautionary measures in regard to EMC and is required to be installed and prepared for initial use as described within the accompanying documents CAUTION Mobile HF Communication devices shouldn t be...

Страница 30: ...ce 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 ...

Страница 31: ...PRS 500 E User Manual 5069 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 ...

Страница 32: ...E User Manual 5069 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 E Table top dimension L x B 2260 mm x 755 mm standard OP PATIENT ...

Страница 33: ...tor Detailed information please find in the enclosed User Manual Technical Description of the Bucky Grid entity 7 4 X ray tube column Focal spot vertical travel horizontal X ray beam 294 1882 5mm Focal spot vertical film distance standard PROGNOST E max 1364 5mm Focal spot vertical table top distance standard PROGNOST E max 1297 5mm Rotation X ray tube assembly around horizontal support arm 180 de...

Страница 34: ...m Al according 21CFR 1020 30 n with 100 kV and a first half value layer thickness HVLT of 2 7mm Al The cover vertical X ray system image receptor stand is defined as application part The aluminium attenuation equivalent of the cover vertical X ray system image receptor stand is typically 0 4 and 0 5 Al mm according to EN 60601 1 3 Tested at 100 kV with a first half value layer thickness HVLT of 3 ...

Страница 35: ...re 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 www protec med com download With this symbol we point out that Usage instructions of the corresponding product is on out Homepage Notes on disposal WEEE Waste of Electrical and Electronic Equipment ...

Страница 36: ...aximum indicated weight Tabletop movements for exposure Longitudinal movement of the tabletop Transverse movement of the tabletop Table height adjustment table up Table height adjustment table down Release tabletop brakes Horizontal movement of the X ray system tube support floor stand Vertical movement of the X ray tube arm Rotation of the X ray tube assembly Horizontal movement of the X ray syst...

Страница 37: ... 50 kW 8 3 Labels Labels on the side of the tabletop Carbon tabletop Composite fibre tabletop 200cm Composite fibre tabletop 226cm Labels on top of the tabletop Maximum allowable Patient 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 tube arm ...

Страница 38: ...t he hands and fingers while moving the tabletop table and or X ray tube assembly unit Labels on the X ray system tube support floor stand and column X ray system image receptor stand Product label Label on the front plate x ray system table Company label 8 4 Position symbols and labels Identification label Identification label At both ends of the rail ...

Страница 39: ...orfwiesen 14 71720 Oberstenfeld Germany 39 von 39 8 5 Abbreviations mm Millimetres cm Centimetres lb Pound kg Kilogram C Degree Celsius hPa Hectopascal DIN German Industry Standard EN European Standard CE CE Mark Hz Hertz ED Duty cycle A Ampere SN Serial number ...

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