Siemens
MOBILETT XP, XP ECO & XP Hybrid Operator Manual 2012
Operator Manual
96 Pages
Preview
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This product is provided with a CE marking in accordance with the regulations stated in Annex II of Directive 93/42/EEC of June 14th, 1993 concerning medical devices. The CE marking applies only to medical devices which have been put on the market according to the above mentioned EC Directive. Unauthorized changes to this product invalidate this declaration. Original language: German
Do you have any notes on this Operator Manual? Your opinion matters a lot to us! We make every effort to continuously improve our product documentation. Therefore, we would like to offer you the opportunity of giving us your direct feedback concerning your requests, suggestions and criticism with respect to this operator manual.
❏ For feedback by fax, please use the following fax number: +49 9131/84-2378 ❏ If you prefer notification by e-mail, please send your feedback to: [email protected] In this case, please quote the entire print number in the footer of this page for reference.
Thank you very much for supporting us in our efforts to improve our products. My notes
Optional information Name Hospital City/country E-mail Telephone/fax Number of fax pages
MOBILETT XP/XP ECO/XP HYBRID SPR8-230.621.01.06.02
Table of Contents
Operator Manual
Table of Contents Chapter: Introduction
5
Use of the product... 5 Intended Use... 5 Body region... 5 Patient group... 5 Contraindications... 5 Physical functionality... 6 User profile... 6 Training... 6 Conditions of use... 7 Maintenance, cleaning, and disinfection... 7 Service... 7 Essential performance characteristics... 7 Frequently used operating functions... 7 Operating functions regarding safety... 7
Information about this Operator Manual... 8 Scope... 8 Supplements and addenda to the Operator Manual... 8 Names and parameters... 8 Values... 8 Layout conventions... 8 Instructions... 9 Conclusion... 9 List... 9 Cross-reference... 9 General information... 9 Warning notes... 10 Information about correcting errors... 10
Chapter: Safety
11
General safety information... 11 Laws and regulations... 11 Scope... 11 Maintenance and inspection... 12 Protective conductor installation... 13 Emergency shutdown... 13 Fire safety... 13 Explosion protection... 14
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Personal safety measures... 15 Mechanical safety, danger zones... 15 Articulated arm system... 16 Radiation protection... 17
Equipment safety measures... 18 Installation, repair... 18 Original accessories... 19 Disposal... 19
Chapter: System description
21
Description of functions... 21 System overview... 21 Main switch... 24 Operating mode selector switch... 25 Motor operation control... 26 X-ray tube unit with collimator... 27 Lead apron bracket... 28 Control and display panel... 29 Potential equalization... 30 Arm system... 30 Hand brake/parking brake... 30
Operation... 31 MOBILETT XP Hybrid Quick Guide... 31 Preparation... 31 Operation... 32 MOBILETT XP Quick Guide... 33 Preparation... 33 Operation... 33 Initial startup... 34 Charge the battery (MOBILETT XP Hybrid system only)... 34 Switching the system on... 34 Battery charge indicator... 35 ECO mode energy saver mode (optional)... 36 Exposure preparation... 37 Positioning the MOBILETT... 37 Setting the radiation field... 38 Setting the radiation field using a diagram... 39 Example: Setting the radiation field... 40 Setting the exposure parameters... 41 Releasing the exposure... 42 Using the exposure release button... 42 Using the IR remote control (option)... 43 Exposure using a DAP measuring system (option)... 45 Shutting down... 46 Switching off the MOBILETT... 46 Disconnecting the power cable... 46
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Transport... 47 Prior to transport... 47 Moving the unit... 48 Tilting the MOBILETT... 50 Using the hand brake/parking brake... 51
Messages... 52 System messages... 52
Chapter: Dosimetry
55
Estimating the beam field intensity... 55 Dose area product... 55 Estimating the dose area product... 56 Example: DAP estimate... 57
Chapter: Technical description
59
Technical Specification... 59 X-ray control console and generator... 59 Classification according to IEC 60 601-1... 61 X-ray tube... 61 Motor drive (MOBILETT XP Hybrid only)... 62 Batteries (MOBILETT XP Hybrid only)... 62 Remote control (option)... 62 Dimensions... 62 DAP equipment (option)... 63 Environmental conditions... 63 Parts subject to wear... 64 Dimensions (mm)... 65 Graphic display of the tube data... 66 Tube load curve... 66 X-ray tube cooling curve... 66 Tube housing heating curve... 67 Tube housing cooling curve... 67 EMC (Electromagnetic compatibility)... 68 External cables... 68 Guidelines and manufacturer's declaration – Electromagnetic emissions... 69 Guidelines and manufacturer's declaration – Electromagnetic interference immunity... 70 Guidelines and manufacturer's declaration – Electromagnetic interference immunity... 71 Recommended separation distances between portable and mobile RF telecommunication devices and the MOBILETT XP... 73
Labels... 74 General information... 74 Location of information labels - CE... 74
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Table of Contents
Chapter: Maintenance
81
Functional and safety checks... 81 Daily checks... 81 Monthly checks... 82 Labels... 82 DAP measuring system (option)... 82 Annual maintenance... 83 Checking the system... 83 Checking the system parts... 83
Cleaning and Disinfection... 84 Cleaning... 84 Cleaning the DAP chamber (option)... 85 Disinfecting... 85
Chapter: Accessories and Options
87
Accessories... 87 Pediatric filters... 87 Protractor... 87
Options... 88 DAP measuring system (option)... 88 Display and control panel... 88 DAP ionization chamber... 89 Remote control (option)... 90
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Operator Manual SPR8-230.621.01.06.02
Introduction
We welcome you as a user of the powerful MOBILETT XP/XP ECO/XP Hybrid, the versatile X-ray system from Siemens.
Use of the product
0
Intended Use
0
The system is a mobile X-ray system for non-diagnostic imaging.
Body region
0
The system is suitable for a large variety of clinical visualizations such as ❏ the head ❏ the spine ❏ the abdomen ❏ the lung ❏ the internal organs ❏ the extremities All applicable country-specific requirements must be met.
Patient group
0
The system is not geared to a particular target group. A limitation of the target patient group might result from medical considerations, but not on the basis of any technical aspects (dangers). All applicable country-specific requirements must be observed.
Contraindications
0
Patients must be informed of any related risks and safety measures during an examination. Prior to the examination, it must be confirmed by a physician that an examination is permissible and checked whether increased precautions are necessary.
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Introduction
Physical functionality
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The MOBILETT XP/XP ECO/XP Hybrid is a conventional analog X-ray system used for free X-ray exposures with X-ray films or CR cassettes in accordance with IEC/ANSI/DIN. The system can only be used for analog radiography.
User profile
0
The system can be used properly only by suitably qualified medical personnel in compliance with the relevant applicable country-specific regulations. This requires operating personnel to be familiar with the Operator Manual. This manual must be studied in detail prior to starting up the system. Pay special attention to the following sections: ❏ General safety information ❏ Personal safety measures ❏ Equipment safety measures ❏ Maintenance
The operating personnel must be instructed in correct and professional operation. Instruction is to be repeated at appropriate intervals. We recommend simulating emergency conditions during training so that appropriate conduct can be taught. As the manufacturer of the system, SIEMENS is not responsible for any impact on its safety, reliability and performance if it is not used in accordance with the Operator Manual.
Please also read the supplements and addenda to the Operator Manual necessitated by technical developments.
Training
0
Provided the operating personnel are suitably qualified, no application training is necessary to use the system. However, if required, voluntary application training can be provided by Siemens employees.
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Introduction
Conditions of use
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The MOBILETT XP/XP ECO/XP Hybrid X-ray system is a mobile system suitable for use in intensive care units, infant wards, emergency rooms, operating rooms, and radiology departments. The unit is also suitable for use in medical practices and is designed for multiple daily applications. When using the system, the applicable country-specific requirements must be observed.
Maintenance, cleaning, and disinfection
0
See the chapter „Maintenance“.
Service
0
See the chapter „Maintenance“.
Essential performance characteristics
0
See the chapter „Safety“.
Frequently used operating functions
0
See the chapter „Operation“.
Operating functions regarding safety
0
See the chapter „Safety“.
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Introduction
Information about this Operator Manual Scope
0
0
This Operator Manual is valid for the following product: ❏ MOBILETT XP No. 018 18 363, including ECO variant ❏ MOBILETT XP Hybrid No. 018 18 454
Supplements and addenda to the Operator Manual
0
◆ Please read the supplements and addenda to the Operator Manual necessitated by technical developments.
Names and parameters
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All names and data of patients and facilities used as examples in this Operator Manual are entirely fictional. Any resemblance to names of real persons and institutions is entirely coincidental. All parameters and images shown in this Operator Manual are examples. Only the parameters displayed on your system are relevant.
Values
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All numbers specified are typical values unless specific tolerances are indicated.
Layout conventions
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The Operator Manual has several registers. At the front of the document there is a detailed table of contents listing the chapters contained in the manual. Certain text passages may be marked with symbols that allow you to grasp the information content of the text faster.
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Introduction
Instructions
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The individual steps contained in procedural instructions guide you in the proper use of your system. ◆ Text of this type is identified by a diamond.
Conclusion
0
– The result of procedural instructions is identified by a dash.
List
0
❏ Text of this type is identified by a square.
Cross-reference
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Cross-references refer you to related topics on other pages or in other chapters. → Cross-references are identified by thin arrows.
General information
0
A note refers to information that is important for safe operation of the system without the presence of any hazard to health or life.
A note is indicated by an exclamation mark "!" and printed in italics.
Information contains tips regarding optimal system use and settings as well as other useful hints.
Additional information is identified by the letter "i" and printed in italics.
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Introduction
Warning notes
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A Warning indicates a danger which, if not observed, can lead to serious injury or even death.
Warning First the source of danger is stated. Possible consequences are then pointed out! ◆ Finally, information on how to avoid the danger is provided. Caution indicates a danger which, if not observed, can lead to minor or moderate injury.
Caution First the source of danger is stated. Possible consequences are then pointed out! ◆ Finally, information on how to avoid the danger is provided.
Information about correcting errors
0
Information on how to solve problems that might occur when performing operating steps is given at the end of the relevant instructions.
In these paragraphs, the problem and the potential cause are described. To solve the problem, perform the operating steps specified here.
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Safety
General safety information
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Laws and regulations
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If legally binding regulations govern the installation and/or operation of the system, it is the responsibility of the installer and/or the operator to observe these regulations. The legally established regulations must be observed in all countries. Deviating from this Operator Manual, values may be set according to country-specific regulations. This product bears a CE marking in accordance with the provisions of regulation 93/42/EEC of June 14, 1993 for medical products. Data related to individual persons are subject to data protection. Please comply with the applicable legal regulations. Legally required tests must be performed at the specified intervals. These tests include, for example, ❏ Constancy test according to the X-ray ordinance (§16 RöV) in the Federal Republic of Germany. ❏ Tests based on DHHS guidelines (Department of Health and Human Services) where applicable.
Scope
0
This Operator Manual is valid for the following product: ❏ MOBILETT XP No. 018 18 363, including ECO variant ❏ MOBILETT XP Hybrid No. 018 18 454
Warning Making changes to the unit Risk of electric shock ◆ It is not allowed to make changes to the unit.
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Safety
Maintenance and inspection
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To ensure the safety of patients, operators and third parties, the system must be checked every 12 months using the check list in the maintenance instructions in order to maintain its reliability and serviceability. All parts of the MOBILETT which, if worn, may represent a safety hazard, must be inspected by trained technical personnel at regular twelve-month intervals, and, if necessary, replaced. This should be performed by the Siemens Customer Service department as part of maintenance work. Before using the equipment for examination, the user must ascertain that all safety-relevant devices function properly and that the system is ready for operation. Image quality
Maintenance should include checking the image quality. Maintenance at regular intervals is recommended to always ensure best image quality.
Performing maintenance
Maintenance work should be performed by trained technical personnel only. If national laws or regulations specify more frequent checking and/or maintenance, these laws or regulations must be observed.
More detailed information is available in the maintenance plan (→ Page 83).
The radiation indicator must only light up during operation when the exposure release button is pressed.
Warning Radiation indicator lights up without the exposure release button being pressed. Unwanted radiation exposure possible! ◆ Immediately switch off the MOBILETT. ◆ Please notify Siemens Customer Service.
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Safety
Protective conductor installation
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If there is doubt about the protective conductor installation, the system must be checked prior to start-up.
Warning Connecting the unit to an outlet without a protective ground Risk of electrical shock ◆ The unit may be connected only to outlets with a protective ground.
Emergency shutdown
0
The power supply connection and power switch must be easily reachable so that the system can be quickly disconnected from the power supply in the case of a safety risk.
Fire safety
0
Caution In the event of fire A fire or smoldering fire can produce toxic gases or fumes! ◆ Switch the MOBILETT off immediately. ◆ Disconnect the power cable from the electrical outlet. ◆ Inform all personnel of the correct procedures in case of fire as part of occupational safety training.
Once cleanup and restoration work in the examination room has been completed, contact Siemens Customer Service prior to starting up the MOBILETT.
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Safety
Explosion protection
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Caution Explosion protection. The system is not designed for operation in areas where there is an explosion hazard. If there is a risk of explosion: ◆ Switch the MOBILETT XP/XP ECO/XP Hybrid off immediately. ◆ The system can, however, be safely used in operating rooms, if a safety distance of at least 25 cm to the gas exit point is observed and the system is operated in compliance with IEC 60601-1.
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Safety
Personal safety measures
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Mechanical safety, danger zones
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The areas marked with arrows in the following illustration indicate possible danger zones.
Caution System movements can cause injury to the user and result in collisions with other objects. Injury, bruising, or crushing of the user and/or damage to the system! ◆ Ensure that no body parts are in the vicinity of the marked danger zones.
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Safety
Articulated arm system
0
MOB00012
Always use the handle on the articulated arm and the X-ray tube unit when lowering the tube unit into the park position.
Caution Movement of the X-ray tube unit can cause injury to the user. Injury, bruising, or crushing of the user! ◆ When positioning the X-ray tube unit, always use the handles to prevent crushing injuries. A spring located inside the articulated arm balances the weight of the arm and holds it steadily in every position.
Caution The counterbalancing spring can break. The counterbalancing spring may cause injury if not handled properly. Injury, bruising, or crushing of the user! ◆ Please notify Siemens Customer Service.
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Safety
Radiation protection For the patient
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❏ Keep the radiation field as small as possible. ❏ Ensure that the patient receives the best possible protection when exposures are taken in the vicinity of the patient's reproductive organs (use gonadal shields or lead-lined rubber covers). ❏ Ensure that the largest possible source-skin distance is maintained.
For the operating personnel
❏ When releasing an exposure, the operator must maintain the greatest possible safe distance from the radiation source. ❏ Always wear protective clothing (lead-rubber apron) when in the patient's vicinity during an exposure. ❏ If necessary, wear a film badge or a pen dosimeter.
For patients and operating personnel
❏ If you are working with the remote control unit, make sure there are no other active systems with infrared remote controls within visual range. This also applies to systems behind a window or behind lead glass. ❏ Be aware that certain materials can result in an increase in radiation exposure (e.g. parts of the OR table) when they are in the beam path.
Warning Radiation indicator lights up without the exposure release button being pressed. Unwanted radiation exposure possible! ◆ Immediately switch off the MOBILETT XP/XP ECO/XP Hybrid. ◆ Please notify Siemens Customer Service.
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Safety
Equipment safety measures
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Installation, repair
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Modifications of or additions to the MOBILETT must be made in accordance with the legal regulations and generally accepted engineering standards only. ❏ As the manufacturer, assembler, installer or importer, Siemens cannot be held responsible for the safety features and for the reliability and performance characteristics of the equipment, if: ❏ Installation, system expansions, adjustments, modifications or repairs are carried out by persons not authorized by Siemens; ❏ defective components affecting safe operation of the MOBILETT are not replaced by original spare parts; ❏ installation of the electrical wiring in the rooms containing the system does not meet the requirements of DIN VDE 0100 Part 710/IEC 60 364-7-710 or the relevant national regulations; ❏ the MOBILETT is used in a manner other than that specified in the Operator Manual.
On request, we will provide you with technical product documentation pertaining to the unit for a fee. However, this does not imply authorization to undertake repairs. We accept no responsibility for repairs performed without our express written approval. We recommend that you obtain a report indicating the nature and extent of the work performed on the unit by the persons carrying out such work. The report must include any changes in rated parameters or operating ranges, as well as the date, the name of the company, and a signature.
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