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PROGNOST XP, XPE & XPE-Akku
Basic diagnostic X-ray system table,
PROTEC GmbH & Co. KG
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Telephone: +49 (0) 7062/92 55-0 E-Mail: protec@protec-med.com
non-powered or powered
Model/ID: 7036-0-17xx
Basic UDI-DI: 426050264X009ZT
Model/ID: 7037-x-17xx
Basic UDI-DI: 426050264X011ZE
Model/ID: 7038-9-17xx
Basic UDI-DI: 426050264X024ZP
Instructions for use
ID No. 5038-0-0002
*Figure PROGNOST XPE-Akku
Version: 1.0
Issued: 2021-05-17
Subject to alterations
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Table of Contents
Related Manuals for Protec PROGNOST XP
Summary of Contents for Protec PROGNOST XP
- Page 1 Model/ID: 7038-9-17xx Basic UDI-DI: 426050264X024ZP Instructions for use ID No. 5038-0-0002 *Figure PROGNOST XPE-Akku Version: 1.0 PROTEC GmbH & Co. KG Issued: 2021-05-17 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
3.2.1 Emergency Stop Switch PROGNOST XP ......................16 3.2.2 Emergency Stop Switch PROGNOST XPE & PROGNOST XPE-Akku ............ 16 Control Elements and Displays of the PROGNOST XP-series ................16 3.3.1 Control Elements and Displays PROGNOST XP ....................16 3.3.1.1 Brake Rollers ................................... 17 3.3.1.2... - Page 4 Charging Cycle and Meaning of the Charging Control LED ............30 Functions of the PROGNOST XP-Series ..........................30 4.3.1 Switching the PROGNOST XP device on and off ................... 30 Safety and Maintenance ....................31 Introduction ...................................... 31 Reusability ......................................31 Cleaning and Disinfection ................................
- Page 5 8.3.3 Labels PROGNOST XPE-Akku ............................46 Positions of the Signs and Labels............................48 8.4.1 Positions of the Signs and Labels PROGNOST XP ..................48 8.4.2 Positions of the Signs and Labels PROGNOST XPE ..................49 8.4.3 Positions of the Signs and Labels PROGNOST XPE-Akku ................50 Abbreviations ....................................
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Page 6: Revision Status
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 NOTE 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 to the PROTEC Technical Service Organisation. -
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 XP-series. Before you work with a product of the PROGNOST XP-series, the complete instructions for use must be read, especially the Safety Instructions and the chapter Handling. -
Page 9: Prognost Xpe-Akku
Corner protection table top, set of 4 • Center stop, for accurate positioning 1.2.2 Hardware and Network System Requirements As a stand-alone product, the PROGNOST XP-series has no hardware or network connection and therefore no hardware or network requirements. 1.2.3 Installation NOTE The installation of a PROGNOST XP-series product must be performed by PROTEC service department or a service company authorized by them. -
Page 10: Floor Loading Capacity
1.2.3.1 Floor Loading Capacity NOTE The products of the PROGNOST XP-series are primarily made of metal pieces. This has a corresponding effect in the weight of the device. The PROGNOST XP has a weight of 103kg. The PROGNOST XPE has a weight of 114kg. -
Page 11: Clinical Benefit
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, products of the PROGNOST XP-series are intended exclusively for use by professional users who are trained in the operation of diagnostic X-ray systems in... -
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
Akku may only be connected to a supply network with a protective earthing conductor. 2.1.2 Device Operation In case of a malfunction, do not use the appropriate PROGNOST XP product anymore and notify PROTEC service department or a service company authorized by them. 2.1.2.1 Operating Type The PROGNOST XPE and PROGNOST XPE-Akku is not intended for continuous operation. -
Page 14: Prognost Xpe & Xpe-Akku
2.1.5 Explosion Protection The PROGNOST XP-series is not designated for use within areas with explosive hazards. 2.1.6 Interaction with Other Devices Interactions with other devices are not known. - Page 15 The user may need to take remedial measures such as relocating or realigning the device. The PROGNOST XP-series 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
PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Control Elements and Displays Main Switch of the PROGNOST XP-series All products of the PROGNOST XP-series do not have a main switch. Emergency Stop Switches of the PROGNOST XP-series 3.2.1 Emergency Stop Switch PROGNOST XP The PROGNOST XP does not have an emergency stop switch. -
Page 17: Brake Rollers
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 1. Arrester for wheels 2. Brake bracket for table top 3. Table top 4. Type Label, UL label, FDA label, Symbols for the brake 5. Rear side long handle (Optional) 6. Front side hand grips (Optional) 7. -
Page 18: Control Elements And Displays Prognost Xpe & Prognost Xpe-Akku
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 3.3.2 Control Elements and Displays PROGNOST XPE & PROGNOST XPE-Akku 1. Arrester for wheels 2. Brake bracket for table top 3. Table top 4. Emergency stop switch 5. Hand control and holder 6. -
Page 19: Fixing Mechanism (Optional)
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 3.3.2.4 Fixing Mechanism (optional) The PROGNOST XPE product can be equipped with a locking device (detent) mounted on the right or left side. In addition to precise positioning of the PROGNOST XPE or PROGNOST XPE-Akku in the X-ray examination room, the locking device enables rotation around the corresponding column axis. -
Page 20: Emergency Stop Switch And Status Indication
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 3.3.3 Emergency Stop Switch and Status Indication The control unit and the drive for the height adjustment are switched off by actuating the emergency stop switch. The emergency stop switch is unlocked by turning it to the right. - Page 21 NOTE State message 2,4 and 5: If these state messages can be deleted with the release button and then occur again, the PROTEC authorized service must be notified and the table must be taken out of order. 21 of 51...
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Page 22: Acoustic Status Indications
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 3.3.3.1 Acoustic Status Indications For all signal lamps state messages, a one-time acoustic message is given by the built-in beeper. Beep sound Meaning Product concerned PROGNOST XPE & General warning PROGNOST XPE-Akku... -
Page 23: Hand Control
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 3.3.4 Hand Control Description of the buttons: Move the table top upwards fast, in combination with button 6 (movement release button) Move the table top downwards fast, in combination with button 6 (movement release button) -
Page 24: Handling
In particular, make sure that none of the patient’s extremities protrude above the table top. • Release the arrester of the rollers and move the PROGNOST XP to the exposure position • Lock the arresters again •... -
Page 25: Operating Of The Prognost Xpe & Prognost Xpe-Akku
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 4.2.2 Operating of the PROGNOST XPE & PROGNOST XPE-Akku 4.2.2.1 Height adjustment of the table top By pressing one of the arrow buttons ▲ ▲ , ▲ or ▼ ▼ , ▼ (in combination with the movement release button) on the hand control, the table top can be moved up or down. -
Page 26: Specifications For Prognost Xpe-Akku Operation
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 CAUTION! The electrical height adjustment is designed for short-time operation • Move the table to the intended exposure position and check that there is no collision between the table top, the table or the image receiver •... - Page 27 The second batter box is charged with the battery box charging station. CAUTION! The batter boxes may only be charged with the PROTEC approved charger! The 20A fuse protecting the 12VDC voltage in the PROGNOST XPE-Akku behind the cover of the power supply station is accessible through the battery box slot.
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Page 28: Battery Charge Level
As an additional short-circuit protection, there is a 25A fuse in the battery box. If this fuse is defective (no voltage is present at the contact surfaces), the PROTEC authorized service department must be notified for the purpose of checking the PROGNOST XPE-Akku battery. -
Page 29: Charging The Battery Box
Only carry out cleaning work on the charger when the charger has been disconnected from the power supply. Clean only with a dry cloth. If the housing or the power plug is damaged, do not operate the charger and inform the PROTEC service department. Battery insertion direction Charging station... -
Page 30: Charging Cycle And Meaning Of The Charging Control Led
Functions of the PROGNOST XP-Series 4.3.1 Switching the PROGNOST XP device on and off All products of the PROGNOST XP-series do not have a separate on and off switch. 30 of 51... -
Page 31: Safety And Maintenance
(see also chapter 4.1). The PROGNOST XP device 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 32: Inspection And Maintenance
PROTEC customer service or a service authorized by PROTEC. All components within the PROGNOST XP-series that 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 33: Maintenance
5.4.5 Product Service Life All products of the PROGNOST XP-series are 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 34: Power Supply
PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Power Supply NOTE The PROGNOST XP does not require a power supply. PROGNOST XPE The power supply is a wide range power supply with an input voltage range of 90…264VAC/47…63Hz. The table is delivered in 2 versions:... -
Page 35: Electromagnetic Compatibility (Emc) According To En 60601-1-2
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Electromagnetic Compatibility (EMC) according to EN 60601-1-2 CAUTION! As a medical electrical device, the PROGNOST XPE and PROGNOST XPE-Akku is subject to special precautionary measures regarding EMC and must be installed and commissioned in accordance with the EMC information contained in the accompanying documents. - Page 36 V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 ± 0,5 kV ± 0,5 kV The quality of the supply voltage should be that of a typical Surges ± 1 kV ± 1 kV commercial or hospital EN 61000-4-5 environment.
- Page 37 V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Test Frequency Immunity Service Frequency Band Testing Level Modulation in MHz in MHz in MHz in V/m Pulse modulation: 380 - 390 TETRA 400 18 Hz GMRS 460, 430 – 470 ±5 kHz Deviation...
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Page 38: Technical Data
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Technical Data Dimensions 7.1.1 Dimensions PROGNOST XP 1889 Table top dimensions: 200 cm x 75,5 cm or 226 cm x 75,5 cm or 200 cm x 65,5 cm Max. Patient weight (distributed load):... -
Page 39: Dimensions Prognost Xpe-Akku
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Table top dimensions: 200 cm x 75,5 cm or 226 cm x 75,5 cm or 200 cm x 65,5 cm Max. Patient weight (distributed load): 230 kg (composite fiber table top) -
Page 40: Attenuation Equivalent
Protection Type and Protection Class The PROGNOST XP has no protection class, whereas the PROGNOST XPE and PROGNOST XPE-Akku corresponds to protection class 1. All devices of the PROGNOST XP-series contain applied parts type B (according to EN 60601-1). Environmental Conditions 7.3.1... -
Page 41: Description Of Symbols, Labels And Abbreviations
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Description of Symbols, Labels and Abbreviations Symbols Atmospheric pressure limit Temperature limit Humidity limit Keep dry Fragile, handle with care This way up Attention, observe accompanying documents Refer to Instructions for use... - Page 42 V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Classification according to EN 60601-1 (type B applied part) Caution: pinch-/crushing hazard for hands and fingers This symbol indicates the need to observe the instructions for use. This is provided in an electronic format (eIFU) on our website.
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Page 43: Type Label
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Type Label 8.2.1 Type Label PROGNOST XP 8.2.2 Type Label PROGNOST XPE 8.2.3 Type Label PROGNOST XPE-Akku 43 of 51... -
Page 44: Labels
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Labels 8.3.1 Labels PROGNOST XP Labels on the front side of the different table tops Table top carbon fiber Table top composite fiber 200cm Table top composite fiber 226cm Labels on the top of the table top Caution: Watch out for possible crushing hazards to fingers or hands while moving the tabletop, table or X-ray unit. -
Page 45: Labels Prognost Xpe
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Labels on the lower table top frame Caution: Table use for patient positioning in radiographic rooms only! Medizinisches elektrisches Erzeugnis in Übereinstimmung mit UL60601-1/CAN/CSA UL = Organization in the USA for the approval C22.2 No. -
Page 46: Labels Prognost Xpe-Akku
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Labels on the lower table top frame Caution: Table use for patient positioning in radiographic rooms only! Medizinisches elektrisches Erzeugnis in Übereinstimmung mit UL60601-1/CAN/CSA UL = Organization in the USA for the approval C22.2 No. - Page 47 V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Labels on the top of the table top Caution: Watch out for possible crushing hazards to fingers or hands while moving the tabletop, table or X-ray unit. Maximum allowed patient weight (distributed load) for the tabletop (Composite-fiber tabletop).
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Page 48: Positions Of The Signs And Labels
Label for the negative pole of the 12VDC battery supply inside the supply station and on the battery box Positions of the Signs and Labels 8.4.1 Positions of the Signs and Labels PROGNOST XP 48 of 51... -
Page 49: Positions Of The Signs And Labels Prognost Xpe
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 8.4.2 Positions of the Signs and Labels PROGNOST XPE 49 of 51... -
Page 50: Positions Of The Signs And Labels Prognost Xpe-Akku
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 8.4.3 Positions of the Signs and Labels PROGNOST XPE-Akku 50 of 51... -
Page 51: Abbreviations
V1.0_2021-05-17 PROGNOST XP, XPE, XPE-Akku Instructions for use 5038-0-0002 Abbreviations Millimetres Centimetres Pound Kilogram °C Degree - Celsius Hectopascal German Industry Standard European Standard CE marking Hertz Duty Cycle Ampere Serial number 51 of 51...
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