MOBILETT Mira Operator Manual March 2014

Operator Manual Mobilett Mira

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 to give 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] When contacting us please refer to the entire print number shown in the footer of this page. 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 Mira SPR8-260.620.01.03.02

Register 1

Introduction

Register 2

Safety

Register 3

System Description

Register 4

Patient data

Register 5

Examination

Register 6

Image Processing

Register 7

Documentation and Archiving

Register 8

Configuration

Register 9

FD Basics

Register 10

Technical Specification

Register 11

Maintenance

Register 12

Options

Operator Manual Mobilett Mira

Overall Table of contents Register 1

Introduction Use of the product ...3 Information about this Operator Manual ...6

Register 2

Safety Laws and regulations ...3 Personal safety ...6 Equipment safety ...10

Register 3

System Description System overview ...3 Switching on the entire system ...15 Imaging system ...20 Exposure preparation ...43 Exposure release ...63 Shutting down the entire system ...69 Transport ...72 System messages ...75

Register 4

Patient data Introduction ...3 Patient registration ...4 Patient task card ...11 Searching for and displaying patient data ...13 Managing patient data ...22

Register 5

Examination Examination notes ...3 Preparing the exposure ...9 Performing the examination ...17

Register 6

Image Processing Image display ...3 Postprocessing ...4

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Operator Manual Mobilett Mira

Register 7

Documentation and Archiving Documentation task card ...3 Transferring/archiving images ...11 Printing (DICOM Print) ...34

Register 8

Configuration User Settings screen ...3 Editing exams and organ programs ...19 Setting parameters ...27 PEX service functions ...40 Administration (HIPAA) ...45

Register 9

FD Basics Solid-state detector ...3 Acquisition technique ...8 Image postprocessing ...21 Quality assurance program ...25

Register 10

Technical Specification Curves and Diagrams ...3 EMC (Electromagnetic compatibility) ...8 Unit components ...14 Labels ...23

Register 11

Maintenance Functional and safety checks ...3 Cleaning and Disinfection ...19

Register 12

Options Equipment options ...3 Potential equalization ...7

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Operator Manual SPR8-260.620.01.03.02

Introduction

Table of contents Use of the product... 3 Purpose... 3 Body region ... 3 Patient group ... 3 Contraindications ... 3 Physical functionality... 3 User profile ... 4 Training ... 4 Conditions of use... 5 Maintenance, cleaning, and disinfection... 5 Service... 5 Performance features ... 5 Frequently used operating functions ... 5 Operating functions regarding safety... 5

Information about this Operator Manual ... 6 Scope... 6 Names and parameters ... 6 Values ... 6 Layout conventions... 6 Instructions ... 6 Conclusion ... 7 List... 7 Cross-reference ... 7 General notes ... 7 Warning notes ... 8 Information about correcting errors ... 8

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Introduction

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Operator Manual SPR8-260.620.01.03.02

Introduction

We welcome you as a user of the powerful Mobilett Mira, the versatile digital X-ray system from Siemens.

Use of the product

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Purpose

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The Mobilett Mira is a mobile X-ray system.

Body region

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The system is suitable for a large variety of clinical visualizations such as ❏ Visualization of lungs and abdomen ❏ Visualization of bones

Patient group

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In principle, the Mobilett Mira can be used for examining all types of patients without restriction. When using this system, the relevant applicable country-specific requirements must be complied with.

Contraindications

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Patients must be informed of any related risks and safety measures during an examination. Prior to the examination, a physician must confirm that an examination is permissible and check whether increased precautions are necessary.

Physical functionality

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With its integrated flat detector, the Mobilett Mira provides brilliant X-ray images for diagnostic purposes. It includes the following special features: Special features

❏ Battery operation ❏ Double articulated arm with a particularly wide range ❏ Rotation arm ❏ Quick and easy handling due to its compact design ❏ Integrated digital imaging system with flat detector

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Introduction

User profile

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The system can be used properly only by suitably qualified medical personnel. This requires operating personnel to be familiar with the Operator Manual. This manual must be studied in detail prior to starting up the system. Special attention must be given to the following sections: ❏ General Safety Information ❏ Personal Safety ❏ Equipment Safety ❏ Maintenance

It is the responsibility of the system operator to ensure that operating personnel are professionally and properly instructed. 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

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It is recommended that operating personnel undergo application training prior to using the system. This training can be conducted by Siemens employees.

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Introduction

Conditions of use

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The digital Mobilett Mira X-ray system is a mobile system suitable for use in intensive care units, emergency rooms, operating rooms and radiology departments. The applicable country-specific requirements must be observed when using the system.

Maintenance, cleaning, and disinfection

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Please refer to → Register 11: Maintenance.

Service

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Please refer to → Register 11: Maintenance.

Performance features

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Please refer to → Register 10: Technical Specification.

Frequently used operating functions

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Please refer to → Register 5: Examination.

Operating functions regarding safety

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Please refer to → Register 2: Safety.

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Introduction

Information about this Operator Manual Scope

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This Operator Manual is valid for the following product: Mobilett Mira

Names and parameters

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All names and data of patients and institutions that are used in this Operator Manual are entirely fictional. Any resemblance to names of existing persons or institutions past or present is entirely coincidental. All parameters and images shown in this Operator Manual are examples. Only the parameters displayed by your system are definite.

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. A detailed table of contents listing all chapters contained in the manual is provided at the beginning. Certain sections of text are marked with symbols to help you quickly identify the information content of the text.

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.

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Introduction

Conclusion

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– The result of procedural instructions is identified by a dash.

List

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❏ 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 notes

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A note refers to information that is important for the safe operation of the system without the presence of any hazard to health or life.

A note is identified by an exclamation mark "!" and printed in italics.

Additional 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 At 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 At 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

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Information on how to solve problems that might occur when performing operating steps is provided at the end of the relevant instructions.

In these paragraphs, the problem and the potential cause are described. Perform the operating steps specified therein to solve the problem.

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Safety

Table of contents Laws and regulations... 3 Maintenance and inspection ... 4 Fire safety ... 5 Explosion protection ... 5

Personal safety ... 6 Impact and crushing hazard ... 6 Overall system... 6 Articulated arm system ... 7 Risk of collision ... 8 Radiation protection... 8 Radiation protection measures ... 8 Radiation protection checks ... 9

Equipment safety ... 10 Mechanical Safety ... 10 Detector... 10 Installation, repair... 10 Original accessories... 11 Electrical Safety ... 12 Emergency shutdown ... 12 Protective conductor installation... 12 Protection against electric shock ... 12 System failure... 13 Transport... 13 Disposal ... 15

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Safety

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Safety

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 is provided with a CE marking in accordance with the provisions of Directive 93/42/EEC of June 14th, 1993 concerning medical devices. 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.

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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 intervals of 12 months, and replaced, if required. 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.

Caution If the system is damaged or exhibits defects, safe operation is no longer guaranteed. Injury to operating personnel, patients or third persons and damage to the product! ◆ In cases of damage, shut down the system immediately and call Siemens Customer Service. ◆ Ensure that any defects are repaired professionally. 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, this must be observed.

More detailed information is available in the maintenance plan (→ Register 11: Maintenance, Page 5).

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Operator Manual SPR8-260.620.01.03.02

Safety

Fire safety

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Behavior in case of fire

Caution Fires within or close to the system may cause the release of poisonous gases or vapors due to burning plastic. This poses a risk of injury to the patient and personnel as well as a risk of equipment damage. Risk of toxic exposure! ◆ Please be sure that you know where the fire extinguisher is located and you know how to use it. ◆ 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 Mira. Ventilation holes

Caution If ventilation holes are obstructed, the system can no longer be properly cooled. Fire or smoke can pose a risk of injury and damage equipment. ◆ Please ensure that ventilation holes are unobstructed at all times.

Explosion protection

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Caution Flammable concentrations of anesthesia gases. Explosion hazard! The system is not designed for operation in areas where there is an explosion hazard. It 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. ◆ Use disposable sterile draping for the X-ray tubes plus collimator and the flat detector.

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Safety

Personal safety

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Impact and crushing hazard

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Overall system

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The areas marked with arrows in the following illustration indicate possible danger zones.

Caution Body parts in hazard areas when equipment is moving. Danger of injuries, contusions or crushing. ◆ Ensure that no body parts are within the region of the marked danger zones.

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Safety

Articulated arm system

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Caution When out of balance, the articulated arm can move unintentionally. Risk of crushing! ◆ When attaching additional weight to the tube or articulated arm, please note that this means it is out of balance. ◆ Check the articulated arm system daily during the function and safety check (see Register Maintenance).

Caution Hands in the hazardous area when X-ray tube assembly is moving. Risk of hands being crushed. ◆ When positioning the X-ray tube assembly, always use the handles to prevent crushing.

Always use the handle on the articulated arm and the X-ray tube assembly when lowering the tube into the park position.

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