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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: 5.0 

Issued: 2022-04-26 

Subject to alterations

 

 

 

 

 
 

 

PROGNOST B 

 

Diagnostic X-ray system mechanics 

 
 

Model/ID: 7014-9-0001 

Basic UDI-DI: 426050264X012ZG 

                     

 
 

Instructions for use 

 

ID No. 5014-0-1002 

 
 

 

Содержание 7014-9-0001

Страница 1: ...eld Germany Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 5 0 Issued 2022 04 26 Subject to alterations PROGNOST B Diagnostic X ray system mechanics Model ID 7014 9 0001 Basic UDI DI 426050264X012ZG Instructions for use ID No 5014 0 1002 ...

Страница 2: ...bited without the express written consent of PROTEC s law department Knowledge of violations of these regulations must be reported immediately to PROTEC GmbH Co KG 2022 PROTEC GmbH Co KG Oberstenfeld 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 protec protec med com ...

Страница 3: ...ts for operation 13 2 1 2 Device Operation 13 2 1 2 1 Operating Type 13 2 1 3 Operating Personnel 13 2 1 4 Crushing and Collision Hazard 14 2 1 5 Explosion Protection 14 2 1 6 Interaction with Other Devices 14 2 1 7 Electromagnetic Environment and Influencing of Devices 14 3 Control Elements and Displays 16 3 1 Main Switch of the PROGNOST B 16 3 2 Emergency Stop Switches of the PROGNOST B 16 3 2 1...

Страница 4: ...4 Wall Stand 32 4 3 5 Patient extending handle 33 4 4 Function of the PROGNOST B 34 4 4 1 Switching the PROGNOST B on 34 4 4 2 Switching the PROGNOST B off 34 5 Safety and Maintenance 35 5 1 Introduction 35 5 2 Reusability 35 5 3 Cleaning and Disinfection 35 5 3 1 Cleaning 35 5 3 2 Disinfection 35 5 4 Inspection and Maintenance 36 5 4 1 Daily Monitoring before and during the Examination Operation ...

Страница 5: ...NOST B Instructions for use 5014 0 1002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 5 of 49 8 1 Symbols 44 8 2 Type Label 45 8 3 Labels 46 8 4 Positions of the Signs and Labels 48 8 5 Abbreviations 49 ...

Страница 6: ...ent subsequent to the date of manufacture will be addressed in service updates distributed to the PROTEC Technical Service Organisation Revision Date Updated pages Comments Author 1 0 14 02 2018 n a First edition 2 0 15 08 2018 7 8 9 11 15 16 17 20 23 24 26 27 28 30 31 32 40 41 42 45 Editorial revision 3 0 2020 11 25 Front page Chap 1 2 1 Chap 1 3 3 Chap 1 4 Product description revised 4 0 2021 05...

Страница 7: ...ose in the area NOTE The user of these accompanying documents is required to carefully read through and carefully consider the instructions warnings and cautions contained therein before starting operation Even if you have already operated similar systems changes in the design production and functional routine of the system described here may have been made which have a significant influence on th...

Страница 8: ...Ray tube assembly X Ray tube collimator and control panel with integrated controls The 360 rotatability of the complete X ray tube column ensures maximum application flexibility Ideal for immobile patients who for example need to be X rayed directly in the hospital bed without repositioning The vertical Bucky wall stand can be delivered in two versions Either mounted on the left or right side of t...

Страница 9: ...luence the EMC conditions Network cable take note of the max cable length in the system documents Wi Fi router Only use devices approved by PROTEC 1 2 2 Hardware and Network System Requirements As a stand alone product the PROGNOST B has an integrated Touch Display therefore it should be ensured that the country specific requirements for data protection and IT security are met 1 2 3 Installation N...

Страница 10: ... use with automatic exposure control Variable cassette detector sizes can be used Formats from 13 cm x 18 cm up to 43 cm x 43 cm Ceiling free tube column stand suitable for rooms with a ceiling height of at least 2 50 meters Maximum application flexibility due to 360 rotatability of the entire X ray tube column Control elements within the control panel easy to reach and easy to activate Reproducib...

Страница 11: ...o function to diagnose treat and or monitor medical conditions 1 8 Indications and Contraindications As standalone products X ray system mechanics have no intended main effect in or at the human body Therefore considered in isolation no indications or contraindications can be shown for them 1 9 Intended User Group As a component of a diagnostic X ray system PROGNOST B is intended exclusively for u...

Страница 12: ...safety instructions contained therein must be carefully read and adhered to NOTE After the initial installation the commissioning must be recorded with the PROTEC acceptance protocol FB 04 07A4 NOTE The PROGNOST B may only be commissioned if all safety measures for operator protection have been met and checked These protective measures can include door contact designated area dosimeter protective ...

Страница 13: ...cal description of the X ray generator To reduce the risk of electric shock the system must be connected to a supply network with protective earthing The system does not have an on off switch It is switched on or off directly by switching on the X ray generator or by the switch on the Power Box In order to separate any electrical voltage from the X ray system the connected X ray generator or the P...

Страница 14: ... Devices Interactions with other devices are not known 2 1 7 Electromagnetic Environment and Influencing of Devices CAUTION The use of other accessories other converters and other cables than those specified by PROTEC or provided in the documentation of the component manufacturer can result in increased electromagnetic interference or reduced electromagnetic immunity of the device and lead to defe...

Страница 15: ...ial areas and in hospitals CISPR 11 class A When used in residential areas for which class B is usually required by CISPR 11 this device may not provide adequate protection for radio services The user may need to take remedial measures such as relocating or realigning the device The PROGNOST B is intended for use in an environment in professional health care facilities e g clinics surgery centres ...

Страница 16: ...T B has the following emergency stop switches which can be used to bring the device to an immediate standstill and disconnect it from the power supply The PROGNOST B has a total of five positions of the emergency stop switches following figures with X ray components 3 2 1 X ray System Table Emergency Stop Switch The emergency stop switch is located on the left side of the X ray system table A Swit...

Страница 17: ... of 49 3 2 2 Tube Stand Emergency Stop Switch The emergency stop switch is located behind the Touch PC on top of the X ray tube 3 2 3 Wall Stand Emergency Stop Switch The emergency stop switch is located on the backside of the wall stand 3 2 4 EC Box emergency stop switch The emergency stop switch is located on top of the EC Box ...

Страница 18: ...ay side room which is intended for X ray personnel The emergency stop switch is located on top of the console CAUTION Even if the emergency stop switch has been activated parts of the PROGNOST B may still be connected to the power Only by switching off or disconnecting the EC Box the PROGNOST B is completely disconnected from the power supply 3 3 Control Elements and Display of PROGNOST B 3 3 1 Co...

Страница 19: ... the handle around the control unit with both hands the electromagnetic brake or motor can be released or activated by pressing the corresponding button on the control unit with the thumb Once released the X ray tube unit can be moved to the desired position 3 3 2 Touchscreen NOTE Different symbols in the PROTEC CONAXX Touch2 software for stationary basic diagnostic X The orientation of the displa...

Страница 20: ...1 The X ray system table will move to the height of 650 mm standard setting above the floor 2 The X ray tube assembly moves automatically to the default SID of 1 m standard setting 3 The Bucky below the table top automatically moves horizontally to center itself with the X ray tube assembly The position is reached and Autotracking is activated If the tube assembly is not within the movement range ...

Страница 21: ...ons Pos 2 Height adjustment The table table top moves upwards Pos 3 Height adjustment The table table top moves downwards Pos 4 Release for table top brakes The floating table top can be moved in all directions NOTE All functions operated through activation of the foot switches can only be activated be stepped twice and held to activate the function As soon as the pedal is released the function mo...

Страница 22: ...ette tray of the Bucky when the X ray tube assembly is positioned Pull out the cassette tray by its handle from the bucky unit until it hits the forward stop Turn the latch for opening closing the clamping device for lateral fixation of the detector counter clockwise Open the clamps far enough to insert a detector of the desired size Insert the detector with its centreline aligned with the notch i...

Страница 23: ...witch to turn on the collimator light and view the opening of the collimator shutter in both axes relative to the detector size Place the object on the detector Use the adjusters to set the collimator shutters to the size of the detector being used The setting is made using the scale on the collimator for the corresponding focus to film distance SID This limits the light beam field to the detector...

Страница 24: ...en Dorfwiesen 14 71720 Oberstenfeld Germany 24 of 49 3 Step Turn the tube head in direction of the lateral detector holder 4 Step Push the tube column to the lateral detector holder 5 Step Adjust the height of the tube arm or of the table that the light field is aligned to the panel ...

Страница 25: ... on the wall stand horizontal central beam By pressing the button for rotation on the tube head the brake for the rotation will be released Turn the X ray unit to the wall stand Set the Bucky Grid Entity on the wall stand to the height for the patient 4 2 2 3 Adjustment of the source to image receptor distance SID NOTE The display shows the correct SID only when making orthogonal exposures on tabl...

Страница 26: ...wall stand on the console of the generator Set the desired organ program or the exposure data and initiate the exposure by pressing the operating elements for exposure preparation exposure triggering 4 3 Operation of the PROGNOST B 4 3 1 Autotracking 4 3 1 1 Autotracking Wall Stand First make sure the X ray tube unit is turned to the Bucky wall stand If the Bucky wall stand Autotracking function i...

Страница 27: ...orizontally along the ground rail to the desired position at first Subsequently the under table Bucky moves automatically in the horizontal direction according to the focus of the X ray tube unit If the table Bucky cannot follow the X ray tube unit because of the tracking range a message appears 4 3 1 4 X ray System Table Autotracking oblique 1 Rotate the tube assembly to the desired angle Autotra...

Страница 28: ...e rotation of the Tube Column Stand 4 Control Panel with Touch Screen Press and hold the tube upward movement button or tube downward movement button The tube assembly will move up or down along the tube column automatically Release the button to stop the movement The X ray tube assembly can be moved up or down at any angle If the system is in table Autotracking mode the height of the tube assembl...

Страница 29: ...valid anymore The safety protection distance can be set in the calibration menu The rotation of the tube assembly at the vertical plane along the horizontal axis is operated manually Press and hold the rotation button or and pull the handle to rotate the tube assembly along the horizontal axis by hand The tube rotates within the range of 180 0 180 The angle of rotation is displayed on the touch sc...

Страница 30: ... 71720 Oberstenfeld Germany 30 of 49 Step the pedal on the base of the tube column stand to release the locking device Pull the handle of the control panel to rotate the tube column along the vertical axis by hand When the tube column stand reaches 0 90 or 180 the locking device engages itself Pedal ...

Страница 31: ...earmost position Step and hold one floating pedal two times double click to release all table top brakes Move the floating table top horizontally or vertically by hand Release the pedal to lock the table top CAUTION Crushing danger around the edges of the table top and pinching hazard below the table top While horizontal movement of the table top it is possible for extremities to become trapped be...

Страница 32: ...screen Automatic Mode Press and hold the buttons for wall stand Bucky upward movement or wall stand Bucky downward movement The wall stand Bucky will move automatically upward or downward along the wall stand column Release the button to stop the movement Control buttons Patient grip Patient extending handle Handle for operator Button to switch on collimator light Activation of Autotracking wall s...

Страница 33: ...erting the patient extending handle into which the handle can be inserted at a 0 or 90 angle NOTE When positioning the patient in front of the wall stand column the operator should instruct the patient to use the patient extending handle WARNING If the Bucky is lowered with an inserted patient extending handle at a 90 angle it could hit the patient on the head If the Bucky height is adjusted for l...

Страница 34: ...B off CAUTION Before switching off the PROGNOST B ensure that the tube head is turned to 0 to avoid accidently turning movements 1 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 NOTE To perform a regular shutdown of the Touch PC it requires an operator ...

Страница 35: ...ion NOTE Caution Possible material changes WARNING Make sure that no liquid enters the interior of the housing during cleaning and disinfection in order to prevent electrical short circuits and or corrosion 5 3 1 Cleaning The cleaning of the PROGNOST B is very easy due to the very good quality surface coating This is usually only done with a dry cloth Do not use corrosive dissolving or abrasive cl...

Страница 36: ...ird parties it is necessary that all checks regarding operational safety and or functionality of the device are performed regularly every 12 months by the PROTEC customer service department or a service provider authorized by PROTEC All components within the PROGNOST B which may pose a risk due to wear and tear must be inspected and if necessary replaced every 12 Months by the PROTEC service depar...

Страница 37: ... is at your own risk 5 4 6 Further Information Detailed information to the individual chapters and for a safe operation transport or storage can be found in the Technical Description of the PROGNOST B 5 4 7 Applied Parts and Parts Considered as Applied Parts Part Definition Applied part or part that is treated like an applied part but is not defined as an applied part Table top Applied part Cover ...

Страница 38: ...or use in the electromagnetic environment specified below The customer or the Operator of the radiographic system should assure that it is used in such an environment Measurement interference Compliance Electromagnetic Environment RF emissions CISPR 11 Group 1 The X ray component uses RF energy exclusively for its internal function As a result its RF emissions are very low and it is unlikely that ...

Страница 39: ...at the supply frequency 50 60 Hz EN 61000 4 8 30 A m 50 60 Hz 30 A m 50 60 Hz Magnetic fields at the mains frequency should correspond to the typical values found in a business and hospital environment Voltage dips short interruptions and fluctuations in the supply voltage EN 61000 4 11 5 UT 95 dip in UT for cycle 5 UT 95 dip in UT for 1 cycle 70 UT 30 dip in UT for 25 30 cycles 5 UT 95 dip in UT ...

Страница 40: ...450 430 470 GMRS 460 FRS 480 FM 5 kHz Deviation 1 kHz Sine 28 710 745 780 704 787 LTE Band 13 17 Pulse modulation 217 Hz 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 28 1720 1845 1970 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 28 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse mo...

Страница 41: ...4 26 PROGNOST B Instructions for use 5014 0 1002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 41 of 49 7 7 1 Dimensions OP Operator CABLE FIXATION WALL STAND COLUMN PATIENT PATIENT PATIENT OP ...

Страница 42: ...able top from the mid position 425 mm Table Bucky Longitudinal movement 500 mm The table top brakes are electromechanically released 7 1 2 Tube Column Stand Vertical focus range of travel horizontal beam projection 350 1800 mm Vertical focus Table distance Standard max 1225 mm Rotation of the X Ray tube assembly around carrying arm axis 180 Detents at 90 0 90 180 Vertical travel carrying arm 1450 ...

Страница 43: ...half value layer thickness of 3 6 mm Al The Bucky cover of the image receptor stand is defined as application part The aluminum attenuation equivalent of the wall stand Bucky cover 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 of 3 6 mm Al 7 2 1 Protection Type and Protection Class The PROGNOST B corresponds to protection class 1 a...

Страница 44: ...n observe accompanying documents Refer to Instructions for use CE marking Manufacturer Medical Device Order reference Serial number Unique Device Identification Production date Classification according to EN 60601 1 type B applied part Caution pinch crushing hazard for hands and fingers Warning high voltage www protec med com download This symbol indicates the need to observe the instructions for ...

Страница 45: ...EEE Waste of Electrical and Electronic Equipment the decommissioning of your equipment Protective earthing Climbing forbidden Do not exceed the maximum indicated weight Do not exceed the maximum indicated weight Do not walk Emergency stop switch label Table height adjustment table up Table height adjustment table down Release table top brakes 8 2 Type Label ...

Страница 46: ... tipping load Labels on the side of the tabletop tube column stand and wall column stand 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 Label on the fron...

Страница 47: ...n the floor rails Label on the tabletop No 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 tube column and wall stand Non professional authorized personnel cannot disassemble the housing Label on the X ray tube cover Warning X ray radiation Label on the front plate of the X ray ...

Страница 48: ...NOST B Instructions for use 5014 0 1002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 48 of 49 8 4 Positions of the Signs and Labels The type label can be found on the backside of the X ray system table ...

Страница 49: ... Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 49 of 49 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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