Protec 7066-9-8050 Instructions For Use Manual Download Page 35

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PRS 500 X

Instructions for use

5066-0-8002

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

35 von 40

7.6

Environmental

7.6.1

Environmental conditions during operation

Ambient Temperature

+ 10°C to + 40°C

Relative humidity

30% to 75% (non-condensing)

Atmospheric pressure

700 hPa to 1060hPa

7.6.2

Environmental Conditions for Shipping and Storage

Ambient Temperature

- 10°C to + 70°C

Relative humidity

10% to 95% (non-condensing)

Atmospheric pressure

500 hPa to 1060hPa

Summary of Contents for 7066-9-8050

Page 1: ...ermany 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 X Basic diagnostic X ray system Model ID 7066 9 8050 Instructions for use Ident Nr 5066 0 8002 PRS 500 X in analogue base configuration ...

Page 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...

Page 3: ...5 2 1 8 Ventilation 15 2 1 9 Interaction with external devices 15 2 1 10 Electromagnetic Environment and the influence of devices 16 3 Control elements and device displays 17 3 1 Control elements and device displays PROGNOST SH 17 3 1 1 Operating unit PROGNOST SH Standard Fehler Textmarke nicht definiert 3 1 2 Operating unit PROGNOST SH TOUCH Fehler Textmarke nicht definiert 3 2 Control elements a...

Page 4: ...troduction 27 5 2 Cleaning and disinfection 27 5 2 1 Cleaning 27 5 2 2 Disinfection 27 5 3 Check up and maintenance 28 5 3 1 Daily Controls prior to or during the unit operation 28 5 3 2 Regular controls 28 5 3 3 Only original spare parts are to be used in situations requiring component replacement Maintenance 28 5 3 4 Warranty 28 5 3 5 Product life time 28 5 3 6 Further Information 28 5 3 7 Appli...

Page 5: ...EC Technical Service Organization Document Effectivity Revision No Date List of effective pages Comments 1 0 2019 05 14 all New created replaces document 5061 0 0002_V4 2 0 2019 07 31 Cap 1 2 6 1 1 7 1 8 1 8 2 8 4 GMDN terms updated Changed optional accessories and images dimension EMC tables removed Symbols added Identification label updated 3 0 2020 06 19 Cap 1 2 2 1 1 3 1 3 1 7 2 Telescopic arm...

Page 6: ...regoing 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 a...

Page 7: ...to 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 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 P...

Page 8: ... tube assembly with housing 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 and Software Software CONAXX 2 Optional Accessories The PRS 500 X can be equipment or customized with the following accessories Patient extending handle Compression band Strain ...

Page 9: ... 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 Vertical range of travel of the focus height from 29 4 cm up to 188 2 cm during horizontal beam projection Electromagnetic brakes for the longitudinal movement of the column stand the vertical movements of the carrying a...

Page 10: ... 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 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 malformation...

Page 11: ...th 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 protec protec med com Internet www protec med com ...

Page 12: ...that 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 ...

Page 13: ...erating 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 inju...

Page 14: ...he 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 X 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 X is not designated for continuous use Duty Cycle S3 15 maximum continuous operation of 1 5 minutes 2...

Page 15: ... 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...

Page 16: ...ices 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 X 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 ...

Page 17: ...ment 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 Brake release for movement of X ray tube assembly around the horizontal 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 arm...

Page 18: ...tal 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 arm is not engaged 10 Option Status LED red if LED on X ray flor stand is not engaged WARNING If the red LED on the right membrane keypad lights up the X ray tube carrier is not engaged In this state ...

Page 19: ...st 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 The detent in the new position centers itself WARNING There is an increased risk of injury if the X ray tube carrier is not engaged Detailed information please find in the accompanying User Manual PR...

Page 20: ...ith 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 i...

Page 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 7 Control elements and device displays of RAPIXX system Detailed information please find in the enclosed User Manual of the RAPIXX system 3 8 Control elements and device displays of CONAXX 2 Detailed information please find in the enclos...

Page 22: ... 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 measure at the collimator or the display ...

Page 23: ...ole 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 Anatomically Programmed Radiography APR witch or manually select the desired exposure factors Start the exposure by pressing the switches for exposure preparation and exposure release not included at the standard delivery 4 1...

Page 24: ...ble brake for the collimator 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 the Collimator to the size of the used cassette The settings will be done on the scale 2 and 8 figure Collimator to the according cassette source to image receptor distance SID So...

Page 25: ...n 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 completely shut down A system restart is only possible after the touch display has been shut down completely Otherwise the touch display will not start 4 9 2 Dosimetric Calibration only for PROVARIO HF The Generator is running a self test at switching ...

Page 26: ...sed documentation of the generator 4 10 Exposure automatic If the PRS 500 X 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 If this happens properly the measured value will be displayed If something is not running properly an Error message will be shown Repeat ...

Page 27: ...urface of the radiographic system PRS 500 X 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 perfo...

Page 28: ...e 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 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...

Page 29: ...age receptor stand Applied part Detector Applied part Optional accessory Patient extending handle optional mounted at the X ray system image receptor stand Part get handled like an application part Compression Band optional Part get handled like an application part 5 3 8 Disposal The X ray system PRS 500 X contains different plastics oils and heavy metal At disposal of exchange parts or the whole ...

Page 30: ... 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 Ω 0 17 Ω 0 5Ω 0 27 Ω 0 29 Ω 0 5Ω Fuse 63A 16A 63A 16A List Power supply generator Type generator CMP 200 DR 50 CMP 200 DR 60 CMP 200 DR 80 Output Power 50kW 65kW 80kW Power supply voltage 400 480 V AC only Phase 3PH N PE Power...

Page 31: ...the marked parts and cables of the PRS 500 X 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 X sends out electromagnetic waves during operation which could cause interference with other devices For EMC guidelines and manufacturers declaration for the generator according to EN 60601 1 2 see ...

Page 32: ...PRS 500 X Instructions for use 5066 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 32 von 40 7 Technical Data 7 1 Dimensions PATIENT PATIENT OP ...

Page 33: ...PRS 500 X Instructions for use 5066 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 33 von 40 OP Operator OP PATIENT ...

Page 34: ...y The attenuation factor must be determined at the final inspection at the customer The variables like X ray tube Collimator etc have influence to the factor The attenuation value of the components can be read out of the accompanying documents of the component The attenuation value has to be determined at the technical specifications If the limits can t be kept please inform PROTEC immediately If ...

Page 35: ...al 7 6 1 Environmental conditions during operation Ambient Temperature 10 C to 40 C Relative humidity 30 to 75 non condensing Atmospheric pressure 700 hPa to 1060hPa 7 6 2 Environmental Conditions for Shipping and Storage Ambient Temperature 10 C to 70 C Relative humidity 10 to 95 non condensing Atmospheric pressure 500 hPa to 1060hPa ...

Page 36: ...e 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 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 ...

Page 37: ...face Attention Electrostatic sensitive devices 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 system tube support floor stand and vertical movement of the X ray tube assembly 8 2 Identification label Exemplary for PRS 500 X with X ray generator 50 kW ...

Page 38: ...71720 Oberstenfeld Germany 38 von 40 8 3 Labels Labels on tube arm Caution Possible pinch crushing hazard fort he hands and fingers while moving the 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 ...

Page 39: ...X Instructions for use 5066 0 8002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 39 von 40 8 4 Position symbols and labels Identification label Identification label At both ends of the rail ...

Page 40: ...fwiesen 14 71720 Oberstenfeld Germany 40 von 40 8 5 Abbreviations 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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