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Summary of Contents for Protec PROGNOST XPE-Akku
- Page 1 PROGNOST XPE-Akku Mobile Patient Table with floating table top and motorized elevation Instruction for Use Ident. Nr. 5033-0-0002 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany...
- 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 AUTHORIZATION OF PROTEC GmbH &...
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Page 3: Table Of Contents
3.1 Safety Aspects ......................16 3.1.1 Requirements for Operation ................16 3.1.2 User ........................16 3.1.3 Emergency-Stop switch..................16 3.1.4 Explosion protection ..................16 3.1.5 Radiation Protection ..................16 3.1.6 Interferences to other devices ................17 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 71720 Oberstenfeld, Germany... - Page 4 7.5 Environmental Conditions ..................29 7.5.1 Operating Environment ..................29 7.5.2 Transport and stock environment ..............29 Description of Symbols, Labels and Abbreviations ............. 30 8.1 Symbols ........................30 8.2 Labels ........................31 8.3 Abbreviations ......................33 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 71720 Oberstenfeld, Germany...
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Page 5: Document Effectivity
The information contained in this document conforms with 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 GmbH & Co. KG Technical Service Organization. Document Effectivity Revision... -
Page 6: Mechanical - Electrical Warning
PROTEC GmbH & Co. KG Customers. Assemblers and other Customers not employed by nor directly affiliated with PROTEC GmbH & Co. KG technical services are directed to contact the local PROTEC GmbH & Co. KG office before attempting installation or service procedures. -
Page 7: Equipment Description
1.2 Intended Purpose The battery powered PROGNOST XPE-Akku is a patient table for examinations with X-ray units (e.g. L/U-arms) for general radiography in diagnostic human medicine use. It most only be used in medically rooms. -
Page 8: Features
• Protection foil (ID: 03030184), for internal covers • Center stop (ID: 7519-0-0000), for transverse table top movement Nameplate For nameplate location refer to Fig. 2-1/6. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 2 of 33 71720 Oberstenfeld, Germany... -
Page 9: Control Elements And Indicators
5: Hand control + holding device 12: Side edge guard 6: Nameplate, UL and FDA Label (version depending) 13: Bumper profile 7: Long handgrip 14: Fixing mechanism 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 3 of 33 71720 Oberstenfeld, Germany... -
Page 10: Brake For Table Top
Bumper profile (optional) (Fig. 2-1/13) The bumper profile avoids a direct contact of rear accessory rail of the table top with the stand or detector support. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 4 of 33 71720 Oberstenfeld, Germany... -
Page 11: Protection Foil (Optional)
The emergency stop switch will be released by clockwise rotation. The three color indicator lamp (Fig. 2-1/9) is placed near the emergency stop switch. It indicates that the table elevation controller is ready for use and the actual status of the PROGNOST XPE-Akku. Attention... - Page 12 Trouble shooting of Status 3: Cool down unit in standby. Reduce patient load After removing source of fault reset the status message by pressing the release button PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 6 of 33...
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Page 13: Acoustic Status Message
5033-0-0002 (Fig. 2-2/6). Status 2, 4 and 5: Call Protec authorized, qualified technical service, if after reset of status message by pressing the release button (Fig. 2-2/6) the failure status is indicated during next moving again. 2.10.2 Acoustic status message With all indicator lamp messages (see chapter 2.10.1) an acoustic beeper message is generated. -
Page 14: Hand Control
To stop motion it is necessary to release at first the motion button (Fig. 2-2/1, 2, 3 or 7, 8) before the motion-release button (Fig. 2-2/6). If not used place hand control into holding device (Fig. 2-1/5). PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 8 of 33... -
Page 15: Column Synchronization
The indicator lamp (Fig. 2-1/9) switches back to bright green or to the status before energy-saving mode (see chapter 2.10.1 table 2.1 and 2.2). If the PROGNOST XPE-Akku is not in operation over a longer time (e.g. weekend), it is recommended to switch off via emergency stop switch (Fig. 2-1/4). -
Page 16: Accumulator-Box
12Vdc contacts Figure 2-3 Figure 2-4 For the operation of the PROGNOST XPE-Akku one charged accumulator-box (Fig. 2-3) must be inserted into the power supply box of the table (Fig. 2-5). Attention! Before replacement of accumulator-box, switch OFF PROGNOST XPE-Akku with emergency stop switch (Abb. -
Page 17: Accumulator State Of Charge
Inside the accumulator-box is a 25A fuse for additional protection (Autofuse rated 32dc 25A Use UL listed types only). In case of defect of this fuse (no voltage at the contacts (Fig. 2-4)) call the Protec authorized service to check the PROGNOST XPE-Akku 2.16.1 Accumulator state of charge... -
Page 18: Accumulator-Box Charge Station (Option)
Do not plug in the charger if there are signs of damage to the housing or power cable and call Protec authorized service. Always disconnect charger from mains before connection or removing accumulator-box PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 12 of 33 71720 Oberstenfeld, Germany... - Page 19 Follow also description of chapter 2.17. Before removing of charged accumulator-box, disconnect charger from mains and then remove charge connector out of accumulator-box. After this remove accumulator-box. 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 13 of 33 71720 Oberstenfeld, Germany...
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Page 20: Charging Of Accumulator-Box
Charger switches over to trickle charge, if accumulator-box is not removed after fully charged. Attention!! Remove charge connector (Fig. 2-7/3) from accumulator-box, if charger is disconnected from mains, to prevent discharging of accumulator to low energy level. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 14 of 33 71720 Oberstenfeld, Germany... -
Page 21: Labels On Head And Foot End Of Table Top
Before a patient get ON or OFF the table, the PROGNOST XPE brake wheels must be fixed in all directions with brake lever (Fig. 2-1/1) 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 15 of 33 71720 Oberstenfeld, Germany... -
Page 22: Operating Instructions
All parts of the system must meet the applicable Medical Device Directive and applicable standards. X-ray systems with the mobile patient table PROGNOST XPE-Akku must be completely installed and officially handed over by PROTEC Customers or by service Customers, authorized by PROTEC, before it can be used. -
Page 23: Interferences To Other Devices
Persons who must be near the patient during x-rays shall wear protective clothing (as e.g. lead aprons). The same applies for maintenance and repair work. 3.1.6 Interferences to other devices There are no interferences to other devices known. 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 17 of 33 71720 Oberstenfeld, Germany... -
Page 24: Warnings
PROGNOST XPE, have to be observed especially when patients get on or off the table. For heavier patients move tabletop to center position above the table base frame! PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 18 of 33... -
Page 25: Exposures With Prognost Xpe-Akku
The following sequence is necessary in order to avoid a collision between X-ray image receptor and table top. • For exposures with the PROGNOST XPE-Akku bring X-ray unit into desired position. • Adjust height of X-ray image receptor to table top height or adjust height of mobile table to image receptor. -
Page 26: Pinch Points And Danger Of Collisions
Remove objects, as e.g. chairs, out of the collision area, before using the table. Pay attention that careless movements of the PROGNOST XPE-Akku table and table top may injure patients, users or other persons and may cause damages to the X-ray tube assembly or the X-ray image receptor. -
Page 27: Operator Maintenance
Personal must make itself familiar with all warnings, placed on the device. They are necessary for the safety and ensure the correct operation. In the event of a malfunction, do not longer use the mobile table and notify immediately PROTEC service or the expressly authorized service provider. -
Page 28: Maintenance Schedule
4.4.1.2 Disinfection All components, including accessories and connecting cables, may be disinfected only by wiping with a disinfectant solution. Please contact PROTEC if detailed information is needed concerning appropriate disinfection materials. The equipment must be well covered with plastic sheets during room disinfection. -
Page 29: Check Of Motion-Release Function
Service or authorized service providers to ensure the safe and reliable operation of the equipment. In the event that scheduled maintenance is not performed, PROTEC will not be responsible for damages occurred by the user or third parties if such damages are the result of improper or missing maintenance. -
Page 30: Electromagnetic Compatibility (Emc) Acc. Iec 60 601-1-2: 2007
General Regulation for safety acc. IEC 60601-1-2 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The PROGNOST XPE-Akku is intended for use in the electromagnetic environment specified below. The customer or the user of the PROGNOST XPE-Akku should assure that it is used in such an environment. - Page 31 5033-0-0002 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The PROGNOST XPE-Akku is intended for use in the electromagnetic environment specified below. The customer or the user of the PROGNOST XPE-Akku should assure that it is used in such an environment.
- Page 32 Table 204 As a result of risk analysis, it has been determined, that the PROGNOST XPE-Akku has no essential performance on which electromagnetic disturbances may have influence. On this a lower compliance level can be used, or measures are not necessary (DIN EN 60601-1-2:2001, 6.8.3.201 i), 1) PROTEC GmbH &...
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Page 33: Combination With Other Equipment
Portable and mobile RF communications equipment and the PROGNOST XPE-Akku The PROGNOST XPE-Akku is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the PROGNOST XPE-Akku can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitter) and the PROGNOST XPE-Akku as recommended below, according to the maximum output power of the communication equipment. -
Page 34: Technical Data
Distance between stroke columns below table top: 1121 mm (44.134 inch) Manual table top and wheels brake. Accumulator-box for PROGNOST XPE-Akku Model ID color 7516-0-0001 RAL 9006 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 28 of 33 71720 Oberstenfeld, Germany... -
Page 35: Electrical Characteristics
(n) at 100 kV and a first half value layer of 2,7 mm Al. Product Life Time The PROGNOST XPE-Akku is designed for a useful lifetime of ten years if used according to specifications and regular maintenance through PROTEC service or authorized service providers. -
Page 36: Description Of Symbols, Labels And Abbreviations
Danger of violent pressure to hands and fingers Don´t exceed maximum weight, risk of breakage Don´t exceed maximum weight, tilting danger Positioning into examination position Positioning in longitudinal Positioning in transversal PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 30 of 33 71720 Oberstenfeld, Germany... -
Page 37: Labels
Plus pole of 12dc Labels inside power supply box Minus pole of 12dc Labels Akku-Box nameplate Label on charger 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 31 of 33 71720 Oberstenfeld, Germany... - Page 38 On table top Maximum allowable weight patients (line load) on tabletop Composite fiber tabletop Maximum allowable weight patients (line load) on tabletop Carbon tabletop PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 30/10/2019 32 of 33 71720 Oberstenfeld, Germany...
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Page 39: Abbreviations
Abbreviations millimeter centimeter kilogram °C Degree centigrade Hektopascal German Industrial Standard European Norm CE-marking Voltage Ampere Frequency int.2min/18min Intermittent duty 2min ON, 18min Off 30/10/2019 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 33 of 33 71720 Oberstenfeld, Germany...
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