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PROGNOST B
Diagnostic X-ray system mechanics
Model/ID: 7014-9-0001
Basic UDI-DI: 426050264X012ZG
Instructions for use
ID No. 5014-0-1002
Version: 5.0
PROTEC GmbH & Co. KG
Issued: 2022-04-26
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 B
- Page 1 Diagnostic X-ray system mechanics Model/ID: 7014-9-0001 Basic UDI-DI: 426050264X012ZG Instructions for use ID No. 5014-0-1002 Version: 5.0 PROTEC GmbH & Co. KG Issued: 2022-04-26 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 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
4.2.1.2 Setting the X-ray unit to the centre of Bucky or Grid Entity ............. 22 4.2.1.3 Inserting a detector into the cassette tray ....................22 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 of 49... - Page 4 Environmental Conditions ............................... 43 7.3.1 Environmental Conditions during Operation ....................43 7.3.2 Environmental Conditions for Shipping and Storage ................43 Description of Symbols, Labels and Abbreviations ............. 44 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 4 of 49...
- Page 5 PROGNOST B Instructions for use 5014-0-1002 Symbols ....................................... 44 Type Label ......................................45 Labels ........................................46 Positions of the Signs and Labels............................48 Abbreviations ....................................49 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 5 of 49...
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Page 6: Revision Status
31, 32, 40, 41, 42, 45 Front page, Chap.1.2.1, Product description 2020-11-25 Chap. 1.3.3, Chap.1.4 revised V3.0 transferred to 2021-05-25 new layout (MDR) 2022-04-26 41, 42 Figure changed PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 6 of 49... -
Page 7: 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 8: Device Description
The instructions for use describe the performance characteristics and operation required for efficient and effective use of the PROGNOST B. Before you work with the PROGNOST B, the complete instructions for use must be read, especially the Safety Instructions and the chapter Handling. -
Page 9: Hardware And Network System Requirements
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... -
Page 10: Floor Loading Capacity
43 cm • Suitable for a Bucky or Grid Entity (analogue and digital) 1.3.3 Product components The PROGNOST B is a diagnostic X-ray system mechanics and consisting of the following essential system components: • A stationary, height-adjustable X-ray system table, •... -
Page 11: Intended Use
Therefore, considered in isolation, no indications or contraindications can be shown for them. Intended User Group As a component of a diagnostic X-ray system, PROGNOST B is intended exclusively for use by professional users who are trained in the operation of diagnostic X-ray systems in accordance with the... -
Page 12: 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 13: General Safety Instructions
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 PROGNOST B anymore and notify PROTEC service department or a service company authorized by them. 2.1.2.1 Operating Type The PROGNOST B is not designated for continuous operation. -
Page 14: Crushing And Collision Hazard
Crushing and Collision Hazard WARNING! It must be ensured that when operating the moving parts of PROGNOST B, no persons or objects are in the obvious danger area of the device. If not observed, it can result in personal injury or damage to the PROGNOST B or other objects. - Page 15 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, physiology practices ...).
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Page 16: Control Elements And Displays
The PROGNOST 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). -
Page 17: Tube 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. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 17 of 49... -
Page 18: Emergency Stop Switch Mini Console
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. Control Elements and Display of PROGNOST B 3.3.1... -
Page 19: Touchscreen
If the angle of the X-ray tube assembly is not ±90°, rotate the unit to this position and move the tube column, if needed, in direction wall stand. The symbol must be pressed to activate Autotracking wall stand. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 19 of 49... - Page 20 The configuration menu many only be operated by PROTEC trained or authorized personnel. Improper changing of settings can lead to malfunctions or endanger patients, operators and third parties. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 20 of 49...
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Page 21: Footswitch
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/movement will immediately stop. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 21 of 49... -
Page 22: Handling
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 size used. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 22 of 49... -
Page 23: Exposure Preparation / Exposure Release
1. Step: Move the tube down beside the table • 2. Step: Press the foot pedal on the tube column wagon to rotate the whole tube column to the left or right side PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 23 of 49... - Page 24 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 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 24 of 49...
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Page 25: Operation At Vertical Wall Stand
Set the X-ray unit to the desired height and align the X-ray tube unit with the Bucky using the centering light of the light sensing device. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 25 of 49... -
Page 26: Exposure Preparation/ Exposure Release
2. The X-ray tube assembly will move up or down automatically, to align tube focus with the wall stand Bucky. If the X-ray tube unit cannot follow the wall stand Bucky because of the angle or the tracking tracking PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 26 of 49... -
Page 27: X-Ray System Table Autotracking
2. The table Bucky moves automatically in horizontal direction to center with the X-ray tube unit. If the X-ray tube unit cannot follow the table Bucky because of the angle or the tracking range, PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 27 of 49... -
Page 28: Tube Column Stand
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 assembly adjusts to the height of the table. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 28 of 49... - Page 29 For exposures on the wall stand Bucky, two stop position can be set in the calibration menu (default values are set to 1.15m and 1.5m). PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 29 of 49...
- Page 30 When the tube column stand reaches 0°, ±90° or 180°, the locking device engages itself. Pedal PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 30 of 49...
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Page 31: X-Ray System Table
Release the table top brakes and move the table top and patient to the position required for the exposure. Lock the table top by releasing the foot pedal. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 31 of 49... -
Page 32: Wall Stand
[ ]. The wall stand Bucky will move automatically upward or downward along the wall stand column. Release the button to stop the movement. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 32 of 49... -
Page 33: Patient Extending Handle
The patient extending handle is only suitable for weightless patient positioning and not as a handle for load support. Move the X-ray unit to the required position before positioning the patient. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 33 of 49... -
Page 34: Function Of The Prognost B
Function of the PROGNOST B 4.4.1 Switching the PROGNOST B on The PROGNOST B is switched on via control panel of the EC-Box. All components are supplied with power via the EC-Box. (1) Switch on the main switch of the X-ray room (2) Switch on the operation PC if applicable. -
Page 35: Safety And Maintenance
(see also chapter 4.1). The PROGNOST B 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 36: Inspection And Maintenance
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 department or a PROTEC authorized service provider. -
Page 37: Warranty
5.4.5 Product Service Life The PROGNOST B is designed for a service life of 10 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 38: Power Supply
Portable RF communication devices (radio devices) should not be used closer than 30 cm (12 in) to the marked parts and cables of the PROGNOST B. Failure to observe can lead to a reduction in the performance characteristics of the device. - Page 39 80 MHz to 2.7 GHz NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structure, objects and people. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 39 of 49...
- Page 40 Pulse modulation: 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 40 of 49...
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Page 41: Technical Data
V5.0_2022-04-26 PROGNOST B Instructions for use 5014-0-1002 Dimensions PATIENT PATIENT *OP - Operator PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 41 of 49... -
Page 42: X-Ray System Table
Longitudinal range of travel column stand: 2200 mm 7.1.3 Wall Stand Column Wall stand Bucky vertical travel range: 350 1800 mm 7.1.4 Weight Without patient: ca. 780 kg PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 42 of 49... -
Page 43: Attenuation Equivalent
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 and contains applied parts type B (according to EN 60601-1). Environmental Conditions 7.3.1... -
Page 44: Description Of Symbols, Labels And Abbreviations
Warning high voltage This symbol indicates the need to observe the instructions for use. This is provided in an electronic format (eIFU) on our website. www.protec-med.com/download PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 44 of 49... -
Page 45: Type Label
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 Type Label PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 45 of 49... -
Page 46: Labels
Caution: Possible collision hazard for head and other body part while moving the Tube assembly or tube column stand. Label on the front of Thorax Bucky housing Maximum allowable weight PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 46 of 49... - Page 47 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 system table Manufacturer Label PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 47 of 49...
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Page 48: Positions Of The Signs And Labels
PROGNOST B Instructions for use 5014-0-1002 Positions of the Signs and Labels The type label can be found on the backside of the X-ray system table. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 48 of 49... -
Page 49: Abbreviations
PROGNOST B Instructions for use 5014-0-1002 Abbreviations Millimeter Centimeter 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 49 of 49...
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