Protec 7067-9-8050 Instructions For Use Manual Download Page 12 | Manualshive

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Protec 7067-9-8050 Instructions For Use Manual Download Page 12

PRS 500 F

Instructions for use

5067-0-8002

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

12 von 41

1.7

Conformity

This product is in conformity with the 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: [email protected]

Internet:

www.protec-med.com

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Summary of Contents for 7067-9-8050

Page 1: ...rmany Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 5 0 Issued 2020 11 12 Subject to alterations PRS 500 F Basic diagnostic X ray system Model ID 7067 9 8050 Instructions for use Id...

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: ...osion 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...

Page 4: ...metric Calibration only for PROVARIO HF 26 4 11 Exposure automatic 27 5 Safety and Maintenance 28 5 1 Introduction 28 5 2 Cleaning and disinfection 28 5 2 1 Cleaning 28 5 2 2 Disinfection 28 5 3 Check...

Page 5: ...00 F Instructions for use 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 5 von 41 8 1 Symbols 37 8 2 Identification label 38 8 3 Labels 39 8 4 Position symbols and label...

Page 6: ...TEC Technical Service Organization Document Effectivity Revision No Date List of effective pages Comments 1 0 2019 05 14 all New created replaces document 5087 0 0002 2 0 2019 07 31 Cap 1 2 1 7 6 1 1...

Page 7: ...egoing 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 fo...

Page 8: ...o the 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 inst...

Page 9: ...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 and Software Software CONAXX 2 Optio...

Page 10: ...ithin 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 act...

Page 11: ...for 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 lu...

Page 12: ...h the 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...

Page 13: ...hat 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 se...

Page 14: ...ating 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 system...

Page 15: ...e power 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...

Page 16: ...the 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 ti...

Page 17: ...ces 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 wo...

Page 18: ...release for vertical movement of X ray tube arm and horizontal movement of X ray floor stand 5 Brake release for vertical movement of X ray tube arm and horizontal movement of X ray floor stand 6 Brak...

Page 19: ...al support arm axis 7 Brake release for vertical movement of X ray tube arm 8 Option Brake release for transversal movement of X ray tube arm 230mm 9 Option Status LED orange if LED is on X ray tube a...

Page 20: ...t be operated downwards Hold the foot lever in this position and turn the X ray tube carrier a little in the desired direction For further rotation the foot lever does not have to be operated anymore...

Page 21: ...th 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 to...

Page 22: ...1 Brake 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 disp...

Page 23: ...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...

Page 24: ...ator operator console control panel select the desired X ray equipment Bucky table without Bucky unit by selecting the corresponding X ray equipment exposure technique switch Press the desired Anatomi...

Page 25: ...llimator By using button 9 figure Collimator the light beam will be activated to control the vent of the collimator to the used cassette With the adjuster 1 and 7 figure Collimator set the lamellas of...

Page 26: ...nerator Switch on the X ray generator button POW1 Switch of the X ray generator button POW2 ATTENTION Specially for the TOUCH option The system is only switched off when the touch display is completel...

Page 27: ...ed documentation 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 obj...

Page 28: ...rface 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 c...

Page 29: ...for damages incurred by the user or third parties if such damages are the result of improper or omitted maintenance Prior to operation creation of X Ray images the operator must ensure that all Safet...

Page 30: ...application 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 mounte...

Page 31: ...tage 380V AC 400V AC 220V AC 380V AC 400V AC 220V AC 230V AC Phase 3PH N PE 1phase 3PH N PE 1phase Power frequency 50 60Hz 50 60Hz 50 60 Hz 50 60 Hz Electrical resistance per phase 0 15 0 17 0 5 0 27...

Page 32: ...500 F Disregarding this can cause a decrease in the performance features of the device CAUTION The X ray generator integrated into the radiographic system PRS 500 F sends out electromagnetic waves du...

Page 33: ...PRS 500 F Instructions for use 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 33 von 41 7 Technical Data 7 1 Dimensions PATIENT PATIENT PATIENT OP...

Page 34: ...PRS 500 F Instructions for use 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 34 von 41 OP Operator OP PATIENT...

Page 35: ...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 system tube support floor stand Focal spot vertica...

Page 36: ...and typically 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 alu...

Page 37: ...This way up Caution note warning notice and safety instructions Refer to user manual CE Mark Manufacturer Trade name Order number Serial number Date of manufacture Classification according to EN 6060...

Page 38: ...tive 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...

Page 39: ...ent 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 Ca...

Page 40: ...PRS 500 F Instructions for use 5067 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 40 von 41 8 4 Position symbols and labels Identification label Identification label...

Page 41: ...den Dorfwiesen 14 71720 Oberstenfeld Germany 41 von 41 Abbreviations mm Millimetres cm Centimetres lb Pound kg Kilogram C Degree Celsius hPa Hectopascal DIN German Industry Standard EN European Stand...

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