Protec PROGNOST C Instructions For Use Manual

Protec PROGNOST C Instructions For Use Manual

Diagnostic x-ray system mechanics
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PROGNOST C
Diagnostic X-ray system mechanics
Model/ID: 7073-9-000X
Basis-UDI-DI: 426050264X013ZJ
Instructions for use
Ident. No. 5073-0-0002
Version: 4.0
PROTEC GmbH & Co. KG
Issued: 2021-05-26
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Subject to alterations
Telephone: +49 (0) 7062/92 55-0 E-Mail: protec@protec-med.com

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Summary of Contents for Protec PROGNOST C

  • Page 1 Diagnostic X-ray system mechanics Model/ID: 7073-9-000X Basis-UDI-DI: 426050264X013ZJ Instructions for use Ident. No. 5073-0-0002 Version: 4.0 PROTEC GmbH & Co. KG Issued: 2021-05-26 In den Dorfwiesen 14, 71720 Oberstenfeld, Germany Subject to alterations Telephone: +49 (0) 7062/92 55-0 E-Mail: protec@protec-med.com...
  • Page 2 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.
  • Page 3: Table Of Contents

    Adjusting the light resp. X-ray field ........................16 4.2.3.6 Exposure preparation / exposure release ....................16 4.2.3.7 Overtable exposures ..............................16 4.2.4 Operation at vertical wall stand..........................16 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 von 30...
  • Page 4 Description of symbols, labels and abbreviations ............27 Symbols ....................................... 27 Type label ......................................28 Labels ........................................28 Position symbols and labels ..............................29 Abbreviations ....................................30 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 4 von 30...
  • Page 5: Document Effectivity

    X-ray mattress changed at technical data table, note attenuation equivalent V3.0 transferred to new layout 2021-05-26 (MDR) PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 5 von 30...
  • Page 6: General Notes

    PROTEC GmbH & Co. KG. Assembly personnel and other persons who are not employees of the technical service department of PROTEC GmbH & Co. KG are requested to contact the local branch of PROTEC GmbH & Co. KG before assembly or service work is started.
  • Page 7: Product Description

    Prior to working with the X-ray systems mechanics PROGNOST C, it is required that the user read the safety notes as well as the chapter regarding operation.
  • Page 8: Installation

    +/-135°. • Integrated safety connector for automatically centring the X-ray tube assembly and the Bucky in the longitudinal direction. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 8 von 30...
  • Page 9: Vertical Bucky Wall Stand

    (17” x 17”), depending on analogue or digital use. Intended Use The X-ray system mechanics PROGNOST C is designated as a component to be used for the assembly of a diagnostic X-ray system for various routine applications in planar X-ray imaging in human medicine.
  • Page 10: Safety Instructions

    Adjustments and calibrations 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.
  • Page 11: General Safety Notice

    X-ray mattress! 2.1.2 Operating of the radiographic system When having troubles with operating of the PROGNOST C, immediately call the Service of PROTEC or an authorized service and stop the using of the PROGNOST C. 2.1.3...
  • Page 12: Pinching And Collision Hazards

    The user may need to take remedial measures such as relocating or realigning the device. The PROGNOST C is intended for use in an environment in professional health care facilities (e.g., clinics, surgery centres, physiology practices ...) PROTEC GmbH &...
  • Page 13: Control Elements And Device Displays

    When operator wants to rotate the tube, it can be rotated manually while holding this button. All Free Zone It will allow to move the tube horizontally on the rail and up/down except the tube rotation. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 13 von 30...
  • Page 14: Radiographic Table

    For vertical movement of Bucky, it is available to move either up or down the Bucky manually while holding the UP/DOWN button as the figure Detailed information please find in the enclosed User Manual of the PROGNOST C. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany...
  • Page 15: Handling

    (13 cm, 18 cm, 24 cm, 30 cm, 35 cm, 40 cm or 43 cm), push the cartridge to the cassette positioner. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 15 von 30...
  • Page 16: Adjusting The Focus-Film Distance (Sid)

    Adjustment of the light-/ radiation field • By using the button “Tube UP/DOWN” the button of the brake for adjusting the height will be released. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 16 von 30...
  • Page 17: Exposure Preparation/ Release

    The Mechanics for basic diagnostic X-ray systems must be switched on! The PROGNOST C starts automatically when the system is switched on and is not started separately. The PROGNOST C switches off automatically when the system is switched off and is not switched off separately.
  • Page 18: Safety And Maintenance

    (see also chapter 4.1). The PROGNOST C must no longer be used with patients if it shows signs of wear (e.g., metal abrasion, wear of insulations) or dangerous technical defects (e.g., torn cable, bent parts) or if the resulting image quality (e.g., artifacts in the image) is insufficient.
  • Page 19: Inspection And Maintenance

    Technical Description in chapter 3 Maintenance and Safety Inspection. In the event that the planned maintenance is not carried out, PROTEC GmbH & Co. KG assumes no liability for damage to the user or third parties, if damage results from inadequate or not carried out maintenance.
  • Page 20: Warranty

    5.4.5 Product Service Life The PROGNOST C is designed for a service life of 7 years when used in accordance with the specifications and regular maintenance by PROTEC service department or a service company authorized by them. After the product has reached the end of its service life, further use is at your own risk.
  • Page 21: Electrical Data

    Input current 2,5 A It is intended that the central power supply of the PROGNOST C is always be connected to an supplied X-ray generator or power box using a hard-wired connection. Select a connection that consider the electrical specifications of the PROGNOST C like in the table above.
  • Page 22 (>95 % dip in UT) for 5/6s for 5/6s 3 V/m Conducted 1 kHz 80% AM disturbances 3 V/m induced by RF fields 150 kHz bis 80 EN 61000-4-6 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 22 von 30...
  • Page 23 2450 2400 – 2570 b/g/n, 217 Hz RFID 2450, LTE Band 7 5240 Pulse modulation: 5500 5100 - 5800 WLAN, 802.11 a/n 217 Hz 5785 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 23 von 30...
  • Page 24: Technical Data

    V4.0_2021-05-26 PROGNOST C Instructions for use 5073-0-0002 Technical Data Dimensions PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 24 von 30...
  • Page 25: X-Ray System Table

    ± 135° Tube stand longitudinal travel: 1265 mm Vertical X-ray system image receptor stand Column height: 1870 mm Vertical shift film center: 400mm - 1765mm PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 25 von 30...
  • Page 26: Attenuation Equivalent

    EN 60601-1-3. Tested at 100 kV with a first half-value layer thickness (HVLT) of 3.7 mm Al. 7.6.1 Protection Art and Protection Class The PROGNOST C is consistent with a protection class 1 device and contains applicable parts Type B (according to EN 60601-1). Environmental 7.7.1...
  • Page 27: Description Of Symbols, Labels And Abbreviations

    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 number Unique Device Identification PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 27 von 30...
  • Page 28: Type Label

    Caution: Possible pinch-/crushing hazard fort he hands and fingers while moving the table top, table and or X-Ray tube assembly unit. Maximum safe working load radiographic table (without X-ray mattress) PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 28 von 30...
  • Page 29: Position Symbols And Labels

    Position symbols and labels Type label Label of the X-ray mattress The label is located on the underside of the X-ray mattress. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 29 von 30...
  • Page 30: Abbreviations

    PROGNOST C Instructions for use 5073-0-0002 Abbreviations Millimetre Centimetre Pound Kilogram °C Degree -Celsius Hectopascal German Industry Standard European Standard CE-Mark Hertz Duty cycle Ampere Serial number PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 30 von 30...

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7073-9-00017073-9-0002

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