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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: 2020-01-30

Subject to alterations

PRS 500 B

Basic diagnostic x-ray system

Model/ID: 7014-9-0000L

User Manual

Ident. Nr. 5014-0-0002

Содержание 7014-9-0000L

Страница 1: ...14 71720 Oberstenfeld Germany Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 4 0 Issued 2020 01 30 Subject to alterations PRS 500 B Basic diagnostic x ray system Model ID 7014 9 000...

Страница 2: ...authorization of PROTEC s law department Report any violations of this requirement to PROTEC GmbH Co KG 2018 PROTEC GmbH Co KG Oberstenfeld These accompanying documents were created and distributed b...

Страница 3: ...n protection 15 2 1 7 Ventilation 15 2 1 8 Interaction with external devices 15 2 1 9 Electromagnetic Environment and the influence of devices 16 3 Control elements and device displays 17 3 1 Control...

Страница 4: ...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 M...

Страница 5: ...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 14 02 2018...

Страница 6: ...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...

Страница 7: ...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...

Страница 8: ...tomized with the following components Horizontal height adjustable patient positioning table with floating tabletop and integrated column stand with control arm Bucky with cassette tray or detector gr...

Страница 9: ...ent Reliable construction Lateral rails of the tabletop prepared to accept a number of table accessories Prepared for the installation of a Bucky with anti scatter grid and 3 field measuring chamber i...

Страница 10: ...RS 500 system must be suitable to answer the diagnostic question and no other more suitable alternative method is available Accordingly it is also described by the International Atomic Energy Agency I...

Страница 11: ...rofessional who are trained in accordance with the corresponding national regulations in the use of diagnostic X Ray equipment and its proper certified use in connection with other medical products ob...

Страница 12: ...t 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 serv...

Страница 13: ...he operating 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 X ray system...

Страница 14: ...n order to disconnect the PRS 500 B from the power the connected X Ray generator must be shut off 2 1 2 Operating of the radiographic system When having troubles with operating the X ray system PRS 50...

Страница 15: ...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 t...

Страница 16: ...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 B and other devices should be studied to make sure they work p...

Страница 17: ...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 swit...

Страница 18: ...transversely within the cassette tray Rotate its latch counter clockwise to unlock it Open the cassette clamps far enough to insert a cassette of the desired size At table bucky insert the cassette w...

Страница 19: ...ress the collimator light switch button 9 figure collimator to turn on the collimator light and view the opening of the collimator shutters in both axes relatives to the cassette and object size Place...

Страница 20: ...720 Oberstenfeld Germany 20 from 41 2 Step Press the foot pedal on the tube column wagon to rotate the whole tube column to the left or right side 3 Step Turn the tube head in direction of the lateral...

Страница 21: ...n the alignment it is not possible to move the tube back down In this case the whole tube column must be pushed beside the table and the tube must be moved down again 4 1 2 Operation at vertical wall...

Страница 22: ...light radiation field By using button 4 figure control handle the button of the brake for adjusting the height will be released Set the collimator to the requested height and align it to the Bucky by...

Страница 23: ...lowing procedure Set Generator Large focal spot 200mA 40mAs Take 8 exposures starting at 50 kV and increment the kV steps of 10 kV up to 120 kV Exposure every 30 seconds otherwise tube may arc See Use...

Страница 24: ...ned to 0 to avoid accidently turning movements and damages of the tube head 1 Press the OFF button appr 2 seconds on the control console The LED ring around the button lights up and shows the turning...

Страница 25: ...r via the Service program into the field DAP test count value x 120 300 1 The current measured test value is displayed in the field DAP measured value x 2 after switching on the Generator For this the...

Страница 26: ...e outer surface of the unit 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...

Страница 27: ...d 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 a...

Страница 28: ...Detector Applied part Housing parts PROGNOST B Part get handled like an applied part Optional accessory Patient extending handle optional mounted at the vertical wall stand Part get handled like an a...

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

Страница 30: ...onic emissions EN 61000 3 2 Class A Voltage fluctuation flicker Emission EN 61000 3 3 Complies The radiographic system PRS 500 B is intended for use in the electromagnetic environment specified below...

Страница 31: ...aration distance in meters m Field strengths for fixed RF transmitter as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may...

Страница 32: ...ications equipment Rated maximum output power of the transmitter W Separation distance according to frequency of transmitter m 150kHz to 80MHz P d 2 1 80MHz to 800MHz P d 2 1 800MHz to 2 5GHz P d 3 2...

Страница 33: ...PRS 500 B User Manual 5014 0 0002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 33 from 41 7 Technical Data 7 1 Dimensions OP Operator PATIENT PATIENT PATIENT OP...

Страница 34: ...mm The Bucky Grid entity and the measure chambers are connected to the generator Detailed information please find in the enclosed User Manual Technical Description of the Bucky Grid entity 7 4 X ray c...

Страница 35: ...ypically 0 6 mm Al und 0 8mm Al according 21CFR 1020 30 n with 100 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...

Страница 36: ...Limitation temperature Limitation humidity Keep dry Fragile Handle with care Do not stack Do not tilt Protect from light This way up Caution Observe accompanying documents Refer to user manual CE Mar...

Страница 37: ...able height adjustment table down Release tabletop brakes Manufacturer Date of manufacture Serial number Order number This symbol indicates that the waste of electrical and electronic equipment must n...

Страница 38: ...Caution Possible pinch crushing hazard fort he hands and fingers while moving the tabletop table and or X Ray tube assembly unit Label on the X ray tube cover left and right side Caution Possible col...

Страница 39: ...putting your hand or fingers under the tabletop as the tabletop is moving Label on the EC Box High voltage to be opened by authorized personnel only Label on the EC Box and the cover X ray column floo...

Страница 40: ...r Manual 5014 0 0002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 40 from 41 8 4 Position symbols and labels The identification label can be found on the side of the table near th...

Страница 41: ...orfwiesen 14 71720 Oberstenfeld Germany 41 from 41 8 5 Abbreviations mm Millimeter cm Centimeter lb Pound kg Kilogram C Degree Celsius hPa Hectopascal DIN German Industry Standard EN European Standard...

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