Protec 7014-9-0000 Instructions For Use Manual Download | Manualshive

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NOTE

All sheets of this document contain proprietary and confidential information of
PROTEC GmbH & Co. KG and is intended for exclusive use by current PROTEC GmbH
& Co. KG customers. Copying, disclosure to other or other use is prohibited without
the express written 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 by the documentation department.

Comments and questions about the documentation, please contact:

PROTEC GmbH & Co. KG

In den Dorfwiesen 14 | 71720 Oberstenfeld

Germany

Phone:

(+ 49) 7062 – 92 55 0

Fax: (+ 49) 7062 – 92 55 60

E-Mail: [email protected]

Internet: www.protec-med.com

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Summary of Contents for 7014-9-0000

Page 1: ... 71720 Oberstenfeld Germany 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 B Basic diagnostic x ray system Model ID 7014 9 0000 Instructions for use Ident Nr 5014 0 0002 ...

Page 2: ...n 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 by the documentation department Comments and questions about the documentation please contact PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany Phone 49 7062 92 55 0 Fax 49 7062 92 55 ...

Page 3: ...on 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 elements and device displays Basic X ray system table 17 3 2 Control elements and device displays collimator 17 3 3 Control elements and device displays of X ray tube 17 3 4 Control elements and devi...

Page 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 Maintenance 27 5 3 4 Warranty 27 5 3 5 Product life time 27 5 3 6 Further Information 27 5 3 7 Applied Parts and parts which get handled like an application part 28 5 3 8 Disposal 28 6 Electrical data...

Page 5: ...re 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 all Original issue 2 0 08 06 2018 6 9 10 19 20 Radiation warning Detector size customized switching on off the system displayed SID 3 0 10 10 2018 New component Venus 50R 1phase 4 0 30 01 2020 20 22 25 Anti collision ...

Page 6: ...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...

Page 7: ...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...

Page 8: ...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 grid unit 3 field measuring chamber Vertical Bucky Wall stand X Ray Generator X Ray tube assembly with housing Anti scatter Grid Collimator Optional components Dose area product meter system and Different direc...

Page 9: ...ient 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 intended for the use with automatic exposure control Useable for variable cassette detector sizes Formats from 13 cm x 18 cm 5 x 7 to 43 cm x 43 cm 17 x 17 depending on analog or digital use Column st...

Page 10: ...PRS 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 IAEA in the document Radiation Protection and Safety of Radiation Sources International Basic Safety Standards Requirement 37 Justification of medical exposures It also refers to the need to consider ...

Page 11: ...professional 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 objects and accessories Suitable users could include the following Radiologist radiology assistants radiology technicians doctors and other medically trained personnel 1 7 Conformity This product is in...

Page 12: ...at 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 NO...

Page 13: ...the 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 systems have to be fulfilled The X ray 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 for...

Page 14: ...In 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 500 B immediately call the Service of PROTEC or an authorized service and stop the using of the system 2 1 2 1 Operating type The PRS 500 B is not designate for continuous use 2 1 3 Operating personnel...

Page 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 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 clothing The protect...

Page 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 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...

Page 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 switch turns on collimator light Pos 10 Measuring tape Detailed information please find in the enclosed User Manual collimator 3 3 Control elements and device displays of X ray tube Detailed information ...

Page 18: ...e 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 with its transverse centerline aligned with the notch in the cassette clamps 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...

Page 19: ...Press 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 object on cassette Adjust the light field with the adjuster 1 and 7 figure Collimator onto the size of the used cassette So the radiation field will be limited to the size of the cassette At the X r...

Page 20: ...1720 Oberstenfeld Germany 20 from 42 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 detector holder 4 Step Push the tube column to the lateral detector holder ...

Page 21: ...in 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 stand 4 1 2 1 Anti collision sensor The anti collision sensor is an infrared sensor It isn t sensitive to dark subjects but very sensitive to bright surfaces It is only suitable for detecting and ant...

Page 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 using the light beam localizer 4 figure control handle Release Button 4 figure control handle to activate the height adjustable brake for the collimator By using button 9 figure Collimator the light ...

Page 23: ...llowing 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 User Manual of the generator and CONAXX 2 User Manual 5 3 Detailed information please find in the enclosed User Manual of the X ray tube 4 2 Operation X ray generator Detailed information please find in...

Page 24: ...rned 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 off state of the system After a few seconds the power of the electronic is turned off and the system is ready to be switched off NOTE To perform a regular shutdown of the Touch PC it is necessary tha...

Page 25: ...he 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 function read from gen 3 has to be executed Modest differences in the measures test value can be caused by air pressure fluctuations or wrong installed measure chambers This window can by opened in the Serv...

Page 26: ...he 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 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 in accorda...

Page 27: ...ed 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 component rep...

Page 28: ...t 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 applied part Mattress optional Part get handled like an applied part 5 3 8 Disposal The X ray system PRS 500 B contains different plastics and oils At disposal of exchange parts or the whole system th...

Page 29: ... 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 frequen...

Page 30: ...delines and Manufacturers declaration electromagnetic interference non life supporting device The radiographic system PRS 500 B is intended for use in the electromagnetic environment specified below The customer or the user of the radiographic system should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment RF emissions CISPR 11 Group 1 This radiogr...

Page 31: ... voltage variations on power supply input lines EN 61000 4 11 5 UT for 0 5 cycle 95 dip in UT 40 UT for 5 cycles 60 dip in UT 70 UT for 25 cycles 30 dip in UT 5 UT for 5 s 95 dip in UT EN 60601 1 2 Test level Mains power quality should be that of a typical commercial or hospital environment If the user of the radiographic system requires continued operation during power mains interruptions it is r...

Page 32: ...d exceeds field strength V m observe the radiographic system to verify normal operation If abnormal performance is observed additional measures may be necessary such as relocating the radiographic system or using a shielded location with a higher RF shielding effectiveness and filter attenuation b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m The radiographic...

Page 33: ...0 Oberstenfeld Germany 33 from 42 Note 1 at 80MHz and 800MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ...

Page 34: ...PRS 500 B User Manual 5014 0 0002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 34 from 42 7 Technical Data 7 1 Dimensions OP Operator PATIENT PATIENT PATIENT OP ...

Page 35: ... 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 column Focal spot vertical travel horizontal X ray beam 350 1800 mm Focal spot vertical film distance max 1295 mm Focal spot vertical table top distance max 1225 mm Angulation X ray tube assembly Arou...

Page 36: ...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 aluminium attenuation equivalent of the cover vertical wall stand is typically 0 95 and 1 Al mm according to EN 60601 1 3 Tested at 100 kV with a first half value layer thickness HVLT of 3 7 mm Al 7 6 1 Prote...

Page 37: ...ation temperature Limitation humidity Keep dry Fragile Handle with care Do not stack Do not tilt Protect from light This way up Caution note warning notice and safety instructions Refer to user manual CE Mark Classification according to EN 60601 1 Type B Caution Collision hazard for head standing people prohibited Caution pinch crushing hazard for hands and fingers Caution Warning high voltage War...

Page 38: ...Table 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 not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer or an authorized waste management company for information c...

Page 39: ...d 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 collision hazard for head and other body part while moving the Tube assembly or tube column stand Labels on the front of Thorax Bucky housing Maximum allowable weight Labels on the table top Maximal Max...

Page 40: ... 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 floor rails Non professional authorized personnel can not disassemble the housing Label on the X ray tube cover Warning X rays Label on the front plate x ray system table Company lable Labels on the X ra...

Page 41: ...er Manual 5014 0 0002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 41 from 42 8 4 Position symbols and labels The identification label can be found on the side of the table near the bottom rear ...

Page 42: ...Dorfwiesen 14 71720 Oberstenfeld Germany 42 from 42 8 5 Abbreviations mm Millimeter cm Centimeter 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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