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PROGNOST F
Basic diagnostic X-ray system table,
non-powered
Model/ID: 7041-5-87xx
Basic UDI-DI: 426050264X008ZR
Instructions for use
Ident. Nr. 5041-0-8002
Version: 7.0
PROTEC GmbH & Co. KG
Issued: 2024-04-08
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 F 7041-5-87 Series
- Page 1 Basic diagnostic X-ray system table, non-powered Model/ID: 7041-5-87xx Basic UDI-DI: 426050264X008ZR Instructions for use Ident. Nr. 5041-0-8002 Version: 7.0 PROTEC GmbH & Co. KG Issued: 2024-04-08 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 others or other use is prohibited without the express written consent of PROTEC´s law department.
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Page 3: Table Of Contents
Cleaning and Disinfection ................................ 16 5.3.1 Cleaning ....................................16 5.3.2 Disinfection ................................... 16 Inspection and Maintenance ..............................16 5.4.1 Daily Monitoring before and during the Examination Operation............17 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 von 25... - Page 4 Description of Symbols, Labels and Abbreviations ............. 22 Symbols ....................................... 22 Type Label ......................................23 Labels ........................................23 Positions of the Sings and Labels............................24 Abbreviations ....................................25 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 4 von 25...
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Page 5: Revision Status
Front page Model ID revised V4.0 transferred to new layout 2021-05-26 (MDR) 2022-12-07 Chap. 1.2.1 Optional Accessories corrected Positioning of the tabletop 2024-04-08 Chap 4.2.1 optimised PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 5 von 25... -
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: Device Description
Hardware and Network System Requirements As a stand-alone product, the PROGNOST F has no hardware or network connection and therefore no hardware or network requirements. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 7 von 25... -
Page 8: Installation
1.2.3 Installation NOTE The installation of the PROGNOST F must be performed by PROTEC service department or a service company authorized by them. For more information, please see separate “Installation manual PROGNOST F.” Contact information of persons qualified to perform installations are available upon request at: PROTEC GmbH &... -
Page 9: Clinical Benefit
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 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 9 von 25... -
Page 10: Safety Instructions
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. -
Page 11: General Safety Instructions
PROGNOST F Instructions for use 5041-0-8002 General Safety Instructions 2.1.1 Device Operation In case of a malfunction, do not use the PROGNOST F anymore and notify PROTEC service department or a service company authorized by them. 2.1.2 Operating Personnel NOTE Only trained and authorized personnel are allowed to work on the PROGNOST F. -
Page 12: Control Elements And Displays
The tabletop can be better shifted with the short handles. CAUTION! Before ascending and descending of the patient, move the tabletop to the front position. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 12 von 25... -
Page 13: Compression Band (Optional)
(4) or by setting the cassette positioner to the corresponding cassette size. The movement range of the Bucky is 545 mm. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 13 von 25... -
Page 14: Handling
Slide the Bucky cassette drawer to the other side. o Position the tabletop as centred as possible (back/front). o The patient should ascend and descend in the middle of the tabletop (green arrow). PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 14 von 25... -
Page 15: Function Of The Prognost F
Function of the PROGNOST F 4.3.1 Switching the PROGNOST F on and off The PROGNOST F does not have a separate on and off switch. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 15 von 25... -
Page 16: Safety And Maintenance
(e.g., bent parts) or if the resulting image quality (e.g., artifacts in the image) is insufficient. In this case, please contact PROTEC service department or a service company authorized by them immediately. Cleaning and Disinfection... -
Page 17: Daily Monitoring Before And During The Examination Operation
12 Months by the PROTEC service department or a PROTEC authorized service provider. In the case that the intended safety-related checks are not carried out, PROTEC GmbH & Co. KG accepts no liability for damage to the operator and third parties if and insofar as damage results from insufficient or non-performed checks. -
Page 18: Applied Parts And Parts Considered As Applied Parts
Please contact your contractual partner or service company or commission a company specialized in disposing the respective components. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 18 von 25... -
Page 19: Power Supply
V7.0_2024-04-08 PROGNOST F Instructions for use 5041-0-8002 Power Supply NOTE The PROGNOST F does not require a power supply. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 19 von 25... -
Page 20: Technical Data
V7.0_2024-04-08 PROGNOST F Instructions for use 5041-0-8002 Technical Data Dimensions PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 20 von 25... -
Page 21: Attenuation Equivalent
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 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 21 von 25... -
Page 22: Description Of Symbols, Labels And Abbreviations
Refer to Instructions for use CE marking Manufacturer Medical Device Order reference Serial number Unique Device Identification Production date Caution: pinch-/crushing hazard for hands and fingers PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 22 von 25... -
Page 23: Type Label
Do not exceed the maximum indicated weight Type Label Labels Labels on the front side of the different tabletops Carbon fibre tabletop Composite fibre tabletop 200cm Composite fibre tabletop 226cm PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 23 von 25... -
Page 24: Positions Of The Sings And Labels
(Composite fibre tabletop). Maximum allowed patient weight (distributed load) for the tabletop (Carbon tabletop). Label on the front plate Company label Positions of the Sings and Labels PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 24 von 25... -
Page 25: Abbreviations
Hectopascal German Industry Standard European Standard CE-Mark Hertz Duty cycle Ampere Serial number V AC Volt (alternating current) V DC Volt (direct current) inch Inches PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 25 von 25...
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