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Protec PROGNOST C, Инструкция по эксплуатации

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V5.0_2021-11-24 

PROGNOST C

 

Instructions for use 

5073-0-0002 

 

 

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

11 von 31 

 

2

 

Safety Instructions 

NOTE 

Contains information that must be observed during operation. 

xxx 

 

CAUTION! 

Contains information which, if not observed, can cause property 
damage. 

xxx 

 

WARNING! 

Contains information which, if not followed, can cause personal 
injury. 

xxx 

 

WARNING! 

Warning of radioactive substances or ionizing radiation. Contains 
information which, if not observed, can cause personal injury. 

xxx 

 
Settings and calibrations that are not described in these instructions for use must be carried out using 
the technical description of the device by PROTEC

 

service department or a service company authorized 

by them. 
 

NOTE 

All instructions supplied with the PROGNOST C must be observed and the 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 C 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 clothing, etc. 

 

CAUTION! 

The instructions for use contain all the information relevant to safety in order 
to generally put the PROGNOST C into operation. The device may only be 
operated by appropriately trained and trained personnel. In this context, 
operation is ensured by clear symbols on the control elements. All further 
information and instructions can be found on the supplied data carrier (USB, 
CD or DVD). This information applies in its entirety as an appendix to these 
instructions for use and must be observed. 

 
 
 

Содержание PROGNOST C

Страница 1: ...ld Germany Telephone 49 0 7062 92 55 0 E Mail protec protec med com Version 5 0 Issued 2021 11 24 Subject to alterations PROGNOST C Diagnostic X ray system mechanics Model ID 7073 9 000X Basis UDI DI 426050264X013ZJ Instructions for use Ident No 5073 0 0002 ...

Страница 2: ...n authorization of PROTEC s law department Report any violations of this requirement to PROTEC GmbH Co KG 2021 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 ...

Страница 3: ...rating Type 12 2 1 3 Operating Personnel 12 2 1 4 Crushing and Collision Hazard 12 2 1 5 Explosion Protection 13 2 1 6 Interaction with Other Devices 13 2 1 7 Electromagnetic Environment and Influencing of Devices 13 3 Control Elements and Displays 14 3 1 Main Switch of the PROGNOST C 14 3 2 Emergency Stop Switch of the PROGNOST C 14 3 3 Floor guided tube column stand 14 3 4 Patient positioning ta...

Страница 4: ... Operation 20 5 4 2 Regular Monitoring 20 5 4 2 1 Quality control by the user 20 5 4 3 Maintenance 20 5 4 4 Warranty 21 5 4 5 Product Service Life 21 5 4 6 Further Information 21 5 4 7 Applied Parts and Parts Considered as Applied Parts 21 5 4 8 Disposal 21 6 Electrical data 22 6 1 Electromagnetic Compatibility EMC according to EN 60601 1 2 22 6 1 1 Guidelines and Manufacturers Declaration Electro...

Страница 5: ...attress Compatible components mattress at characteristic table added symbols and labels cleaning mattress added to technical data table 3 0 2021 03 11 7 8 18 19 20 21 23 24 25 26 27 X ray mattress description compatible components note X ray mattress at characteristic table cleaning disinfection lifetime applied parts symbols and labels chapter power supply connection X ray mattress changed at tec...

Страница 6: ...ose in the area To the User 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 inf...

Страница 7: ...ed on the ground behind the table All movements of the column stand are smooth and locked by electromagnetic brakes The weight balanced support arm is prepared for the installation of an X ray tube assembly X ray tube collimator and control panel with integrated controls 1 2 1 Models PROGNOST C 7073 9 0001 Wall stand left PROGNOST C 7073 9 0002 Wall stand right Optional Accessories The PROGNOST C ...

Страница 8: ...cteristics 1 3 1 Patient positioning table Floating table top Table top colour white Electromagnetic table top brake for effortless patient positioning A low optimized distance between the table top surface and the film detector surface Large adjustment range of the table top for position of the patient Reliable construction Prepared for the installation of a Bucky with anti scatter grid and 3 fie...

Страница 9: ...ion of conventional two dimensional X ray images for creation or specification of findings as a basis for treatment decisions 1 6 Patient Target Group s The intended patient group includes all people for whom a justifying indication for a medical X ray has been given by a physician with the necessary expertise in radiation protection There are no general or fundamental restrictions on the patient ...

Страница 10: ... requirements of Regulation EU 2017 745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices including all applicable corrigenda The declaration of conformity is available upon request from PROTEC 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 Internet www protec med com ...

Страница 11: ...supplied with the PROGNOST C must be observed and the 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 C may only be commissioned if all safety measures for operator protection have been met and checked These protective measures can incl...

Страница 12: ...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 Power Box must be switched off 2 1 2 Device Operation In case of a malfunction do not use the...

Страница 13: ...ead to defective operation CAUTION The use of the PROGNOST C immediately next to other devices or with other devices in a stacked form should be avoided as this could result in defective operation If use in the manner described above is nevertheless necessary the PROGNOST C and the other devices should be observed to ensure that they are working properly NOTE The properties of this device determin...

Страница 14: ...device to an immediate standstill and disconnect it from the power supply 3 3 Floor guided tube column stand Longitudinal movement tube column Brake for the longitudinal horizontal movement of the tube column Tube head up down Brake for the height positioning vertical movement of the tube head Tube Rotation Brake for the tube head rotation around the carrying axis Free movement sensor beneath the ...

Страница 15: ...pplied with power that they switch off and the table top can be moved It must be ensured that no objects are continuously laying in the light barrier and permanently trigger it otherwise the brakes are supplied with continuous current and could get damaged 3 5 Vertical Bucky Wall Stand Brake for the vertical movement of the wall stand Bucky Up down release button Light barrier to release the table...

Страница 16: ... assembly in the longitudinal direction along the radiographic X ray table until the Bucky Grid Entity snaps into the safety coupling 4 2 3 3 Inserting a cassette into the cassette tray A film cassette may be placed into the cassette tray after the X ray tube assembly is positioned Pull out the cassette tray by its handle from the Bucky Grid Entity unit until it hits the forward stop Rotate the la...

Страница 17: ...djustment of image receptor distance SID Release brake of the tube column by pressing button Longitudinal movement tube column and adjust the source to image receptor distance SID which will be used for the exposure Notice the focus area of the scanning unit Bucky and Grid Entity Those settings must be done with the measuring tape inside the collimator or with the markings on the upper guidance of...

Страница 18: ...Oberstenfeld Germany 18 von 31 When the generator or Power Box is turned on at the power button a self test runs on the generator and control panel After successful completion of the self test the parameters are displayed NOTE The mechanics for basic diagnostic X ray systems PROGNOST C must be switched on ...

Страница 19: ... a service company authorized by them immediately 5 3 Cleaning and Disinfection 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 C is very easy due to the very good quality surface coating This is usual...

Страница 20: ...ages dents scratches cracks etc Check the movement of the components table top X ray column wall stand 5 4 3 Maintenance The required maintenance must be carried out by PROTEC service department or a service company authorized by them in order to ensure the safe and reliable functionality of the device The maintenance intervals depend on the frequency of use The required specifications can be foun...

Страница 21: ... 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 C 5 4 7 Applied Parts and Parts Considered as Applied Parts Part Definition as applied part or parts which get handled like an application part but not defined as applied part Table top Applied part Cover image receptor floor s...

Страница 22: ... to special precautionary measures regarding EMC and must be installed and commissioned in accordance with the EMC information contained in the accompanying documents CAUTION Portable RF communication devices radio devices should not be used closer than 30 cm 12 inches to the marked parts and cables of the PROGNOST C Failure to observe can lead to a reduction in the performance characteristics of ...

Страница 23: ...t output lines 2 kV for power supply lines 1 kV for input output lines The quality of the supply voltage should correspond to that of a typical business or hospital environment Surges EN 61000 4 5 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV The quality of the supply voltage should be that of a typical commercial or hospital environment Magnetic field at the supply frequency 50 60 Hz EN 61000 4 8 30 A m 50 6...

Страница 24: ... Immunity Testing Level in V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 27 450 430 470 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...

Страница 25: ...C Instructions for use 5073 0 0002 PROTEC GmbH Co KG In den Dorfwiesen 14 71720 Oberstenfeld Germany 25 von 31 7 Technical Data 7 1 Dimensions Room plan version 1 operation of the system PATIENT PATIENT PATIENT PATIENT OP OP OP ...

Страница 26: ...able top NOTE The device requires a room size of at least 4250mm so that it can be fully operated in the room It should be noted that the table top can only be removed from the side of the table To mount or remove the table top the room must either have a size of at least 6000mm or it is necessary to move components to have more space available PATIENT PATIENT OP OP PATIENT OP PATIENT ...

Страница 27: ...mid position 500 mm The brakes of the table top are used electro mechanic 7 3 Bucky unit Longitudinal travel 280 mm Table top film distance 75 mm The Bucky unit and the measure chambers are connected to the generator 7 4 X ray stem tube support floor stand Focal spot vertical travel horizontal X ray beam 400 mm 1765 mm Focal spot vertical film distance max 1150 mm Rotation X ray tube assembly arou...

Страница 28: ... first half value layer thickness of 2 7mm Al The vertical wall stand Bucky cover is defined as an application part The aluminium attenuation equivalent of the cover vertical wall stand is typically 0 5 and 0 6 Al mm according to EN 60601 1 3 Tested at 100 kV with a first half value layer thickness of 3 7 mm Al 7 6 1 Protection Art and Protection Class The PROGNOST C corresponds to protection clas...

Страница 29: ...imit Humidity limit Keep dry Fragile handle with care This way up Attention observe accompanying documents Refer to Instructions for use CE marking Classification according to EN 60601 1 type B applied part Caution pinch crushing hazard for hands and fingers Do not exceed the maximum indicated weight Do not exceed the maximum indicated weight Manufacturer Medical Device Order reference Serial numb...

Страница 30: ...ns for use This is provided in an electronic format eIFU on our website Disposal instructions WEEE Waste of Electrical and Electronic Equipment Protective earthing 8 2 Type label 8 3 Labels Labels on the side of the table top Maximum safe working load radiographic table Label on the table top and tube support floor stand Caution Watch out for possible crushing hazards to fingers or hands while mov...

Страница 31: ...14 71720 Oberstenfeld Germany 31 von 31 8 4 Position of the signs and labels 8 5 Abbreviations mm Millimetre cm Centimetre 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 Type label ...

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