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PROGNOST XS
Basic diagnostic X-ray system table,
non-powered
Model/ID: 7034-0-0000
Basic-UDI-DI: 426050264X023ZM
Instructions for use
Ident. No. 5034-0-0002
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 XS
- Page 1 Basic diagnostic X-ray system table, non-powered Model/ID: 7034-0-0000 Basic-UDI-DI: 426050264X023ZM Instructions for use Ident. No. 5034-0-0002 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 NOTE This document contains 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. Knowledge of violations of these regulations must be reported immediately to PROTEC GmbH &...
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Page 3: Table Of Contents
Control Elements and Device Displays ................12 Main switch of the PROGNOST XS ............................12 Emergency stop switch of the PROGNOST XS ......................12 Control elements and displays of the PROGNOST XS ..................... 12 Brake rolls ....................................12 Handling ..........................13 Requirements before and during Operation ........................ - Page 4 V4.0_2021-05-26 PROGNOST XS 5034-0-0002 Instructions for use Warranty ....................................19 Product life .................................... 19 Parts with direct patient contact ..........................19 Disposal notes ..................................19 Power supply ........................20 Technical Data ........................21 Dimensions ......................................21 Attenuation Equivalent ................................21 Protection Type and Protection Class ........................
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Page 5: Revision Status
The information contained in this document conforms to the configuration of the equipment as of the date of manufacture. Revisions to the equipment subsequent to the date of manufacture will be addressed in service updates distributed of the PROTEC GmbH & Co. KG Technical Service Organisation. Revision Status Revision... -
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
The instructions for use describes the performance characteristics and operational aspects, required for efficient and effective use of the PROGNOST XS. Prior to working with the PROGNOST XS, the operator is required to read through the instructions for use, especially the safety notes as well as the chapter regarding operation. -
Page 8: Performance Characteristics
Large radiolucent working area Intended Use The PROGNOST XS mobile X-ray system table is intended to be used as a component of a diagnostic X- ray system for patient positioning for various routine applications in planar X-ray imaging in human medicine. -
Page 9: 1.10 Conformity
This product complies with the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th 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 Telephone: +49 (0) 7062 –... -
Page 10: Safety Instructions
After the initial installation, the commissioning must be recorded with the PROTEC acceptance protocol FB-04-07A4. NOTE The commissioning of the PROGNOST XS can only be done if all safety notes and operator security measures have been met. These operator safety measures can be: door contact, marked area, dosimeter, safety clothing …... -
Page 11: General Safety Instructions
Instructions for use General Safety Instructions Operating of device In the event of malfunctions, the PROGNOST XS must no longer be used and the PROTEC customer service department or a service department authorized by PROTEC must be notified. Operating Personnel... -
Page 12: Control Elements And Device Displays
The PROGNOST XS does not have a main switch, as it is a non-active medical device. Emergency stop switch of the PROGNOST XS The PROGNOST XS does not have an emergency stop switch, as it is a non-active medical device. Control elements and displays of the PROGNOST XS 1. -
Page 13: Handling
(see chapter 5.3). Operation of PROGNOST XS Exposures with the PROGNOST XS Following procedure must be observed to prevent collisions with the PROGNOST XS, the image receiver or other furniture. • X-ray device, e.g. swivel arm system, to the 0 degree position •... -
Page 14: Function Of The Prognost Xs
V4.0_2021-05-26 PROGNOST XS 5034-0-0002 Instructions for use Function of the PROGNOST XS Switching the PROGNOST XS ON and OFF The PROGNOST XS does not have a main switch, as it is a non-active medical device. 14 of 25... -
Page 15: Safety And Maintenance
(see also Chapter 4.1). The PROGNOST XS must no longer be used with patients if it shows signs of attrition (e.g., metal abrasion, abrasion of insulations) or dangerous technical defects (e.g., torn cable, bent parts) or if the resulting image quality (e.g., artefacts in the image) is insufficient. -
Page 16: Daily Monitoring Before And During The Examination Operation
In the case that the scheduled checks are not carried out, PROTEC GmbH & Co. KG will not be liable for damage to the user and third parties if and insofar as damage results from insufficient or non- performed checks. - Page 17 5034-0-0002 Instructions for use PROTEC Dealer: Service Technician Name: Service Technician No.: Customer: Customer No.: Place of Installation: PROGNOST XS No.: 7034-0-0000 Serial Number: Annually for Every 5 years for systems with systems with less less than 100 than 100...
- Page 18 V4.0_2021-05-26 PROGNOST XS 5034-0-0002 Instructions for use Final Report: No safety or function-relevant problems detected Next maintenance in 6 / 12 / ____ months Remarks, notes: ………………………………………………………………………………………………….………… ………………………………………………………………………………………………….………… ………………………………………………………………………………………………….………… Inspector: ………………………….………… Date: …………………… Signature: ………………………………………...
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Page 19: Warranty
Warranty service may only be performed by trained specialists. Product life The PROGNOST XS is designed to have a product life of 10 years when used in accordance with the specifications and is regularly maintained by PROTEC customer service or an authorized service provider. -
Page 20: Power Supply
V4.0_2021-05-26 PROGNOST XS 5034-0-0002 Instructions for use Power supply NOTE The PROGNOST XS does not require power supply. 20 of 25... -
Page 21: Technical Data
The brakes of the wheels are mechanically operated. Attenuation Equivalent WARNING! The PROGNOST XS attenuation factor must be considered during the acceptance test. The aluminium attenuation equivalent of the table top is typically 0, 7 and <0, 8mm Al according to EN 60601-1-3 at 100 kV with a first half-value layer thickness of 3, 7mm Al and typically 0, 6mm Al and <0,8mm Al according 21CFR §... -
Page 22: Protection Type And Protection Class
PROGNOST XS 5034-0-0002 Instructions for use Protection Type and Protection Class The PROGNOST XS does not comply with any protection class and does not contain any applied parts. Environmental Conditions Environmental conditions during operation Ambient Temperature + 10°C to + 40°C... -
Page 23: Description Of Symbols, Labels And Abbreviations
V4.0_2021-05-26 PROGNOST XS 5034-0-0002 Instructions for use Description of Symbols, Labels and Abbreviations Symbols Air pressure limit Temperature limit Humidity limit Keep dry Fragile, Handle with care This way up Attention, observe warnings and precautions Refer to the manual CE marking... -
Page 24: Identification Label
V4.0_2021-05-26 PROGNOST XS 5034-0-0002 Instructions for use This symbol indicates the need to consult the operating instructions. This is provided in an electronic format (eIFU) on our website. www.protec-med.com/download Disposal instructions; WEEE , Waste of Electrical and Electronic Equipment Protective earth... -
Page 25: Position Of The Symbols And Labels
V4.0_2021-05-26 PROGNOST XS 5034-0-0002 Instructions for use Labels on the lower table top frame Caution: Watch out for possible crushing hazards to fingers or hands during movements of the table or X-ray unit Position of the Symbols and Labels Abbreviations...
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