SIREMOBIL Compact L Operator Manual Feb 2014

SIREMOBIL Compact L Operator Manual

www.siemens.com/healthcare

Manufacturer’s note: 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: English

Global Siemens Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Business Unit Siemens AG Medical Solutions X-Ray Products Henkestr. 127 DE-91052 Erlangen Phone: +49 9131 84-0 www.siemens.com/healthcare

Global Siemens Healthcare Headquarters Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Phone: +49 9131 84-0 www.siemens.com/healthcare

www.siemens.com/healthcare

Order No. SPR2-130.620.08.04.02 | Printed in Germany | © 02/2014, Siemens AG

Legal Manufacturer Siemens AG Wittelsbacherplatz 2 DE-80333 Muenchen Germany

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.

o For feedback by fax, please use the following fax number: +49 9131/84-2378 o 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

SIREMOBIL Compact L SPR2-130.620.08.04.02

Register 1

Introduction

Register 2

Safety

Register 3

Base system

Register 4

Memoskop

Register 5

Technical Specification

Register 6

Maintenance

Register 7

Accessories

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 Maintenance and inspection ...5 Malfunctions ...7 Fire protection...11 Explosion protection ...11 Overload protection ...12 Personal safety ...13 Equipment safety...21

Register 3

Basic System System configuration ...3 System overview ...4 Overview of operating elements and displays...5 Operation ...8

Register 4

Memoskop Memoskop CX Digital image memory...3 Memoskop CX 25 Digital image memory...63

Register 5

Technical Specification Curves and diagrams ...3 Notes concerning electromagnetic compatibility (EMC)...11 Technical Specification ...16 Labels ...21

Register 6

Maintenance Functional and safety checks...3 Cleaning and disinfection...9

Register 7

Accessories Accessories ...3

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Overall Table of Contents

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Operator Manual SPR2-130.620.08.04.02

Register 1

Introduction

Table of Contents Use of the product ...3 Purpose ...3 Body region ...3 Patient group ...3 Contraindications ...4 Physical functionality ...4 User profile ...4 Training ...5 Conditions of use ...5 Maintenance, cleaning, and disinfection ...5 Service ...5 Essential performance characteristics ...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 ...6 List ...7 Cross-reference ...7 General notes ...7 Warning notes ...7 Information about correcting errors ...8

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Introduction

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Operator Manual SPR2-130.620.08.04.02

Register 1

Introduction

We welcome you as a user of the powerful multifunctional SIREMOBIL Compact L C-arm system from Siemens.

Use of the product

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Purpose

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SIREMOBIL Compact L is a mobile X-ray image intensifier system for non-diagnostic imaging such as surgical disciplines.

Body region

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The system is suitable for a large variety of clinical visualizations such as the o Visualization of bones o Visualization of vessels, soft tissues o Visualization of implants o Visualization of surgical instruments

Caution Non-permitted use of the X-ray system outside of its stated intended use presents a risk to the patient and operating personnel u The X-ray system may be used in the aforementioned clinical applications and procedures only.

Patient group

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In principle, SIREMOBIL Compact L can be used for examining all types of patients provided that the relevant applicable country-specific regulations are complied with at all times, e.g. in pediatrics.

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Introduction

Contraindications

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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.

Physical functionality

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SIREMOBIL Compact L is a compact, economical and powerful mobile X-ray image intensifier system with digital image processing for fluoroscopy and radiography. The following operating modes are available: Fluoroscopy, Pulsed Fluoroscopy, Digital Radiography, Subtraction (SUB)1 and Roadmap1.

User profile

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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: o General safety information o Personal safety measures o Equipment safety measures o Maintenance

1 optional

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Operator Manual SPR2-130.620.08.04.02

Introduction

Training

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The operating personnel must be instructed in correct and professional operation. One-time instruction in the use of the system can take place either through application training provided by a Siemens qualified application trainer or through self-training based on these documents. Training should be repeated at appropriate intervals as required. 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.

Conditions of use

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The compact SIREMOBIL Compact L C-arm system is a mobile system suitable for use in hospitals, clinics or outpatient practices. Follow the respective country-specific prerequisites. In addition, the system is suited for operation in hospital networks (IEC 60601-1 Chap. 14.13 IT security statement). For more information, see the technical documentation.

Maintenance, cleaning, and disinfection

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Refer to the "Maintenance" chapter.

Service

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Refer to the "Maintenance" chapter.

Essential performance characteristics

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Refer to the "Technical Specification" chapter.

Frequently used operating functions

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Refer to the "Examination" chapter.

Operating functions regarding safety

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Refer to the "Safety" chapter.

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Introduction

Information about this Operator Manual Scope

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This Operator Manual is valid for the following product: o SIREMOBIL Compact L

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.

Instructions

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The individual steps contained in procedural instructions guide you in the proper use of your system. u Text of this type is identified by a diamond.

Conclusion

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

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Introduction

List

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o 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 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.

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! u Finally, information on how to avoid the danger is provided.

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Introduction

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! u 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 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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Operator Manual SPR2-130.620.08.04.02

Register 2

Safety

Table of Contents Laws and regulations ...3 Software ...3 Equipotential bonding ...4 Electromagnetic compatibility ...4 Use in connection with high frequency ...4 Maintenance and inspection ...5 Malfunctions ...7 Fault and error messages ...7 Malfunction of electrics ...8 Switching to emergency power supply ...9 System failure ...9 EMERGENCY STOP ...10 Fire protection ...11 Explosion protection ...11 Overload protection ...12 Personal safety ...13 Open heart and skull examinations ...13 Crushing hazards on the C-arm chassis ...13 Crushing hazard on the monitor trolley ...15 Tube housing temperature ...16 Mechanical damage ...16 Radiation protection ...17 Deterministic radiation effect ...18 Position and extent of the main operating area ...19 (according to DIN EN 60601-1-3) ...19 Maximum scattered radiation in the relevant operating area ...20 Radiation interruption for all operating modes ...20 Equipment safety ...21 Installation, repair ...21 Original accessories ...22 Combination with other systems ...22 Positioning the C-arm ...22 Disposal ...23

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Safety

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Operator Manual SPR2-130.620.08.04.02

Register 2

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. 3rd-Edition

Regulations required by law and the radiation protection 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 is subject to data protection. Please observe the relevant legal provisions. Legally required tests must be performed at the specified intervals. These tests include, for example, o Constancy test according to the X-ray ordinance (§16 RöV) in the Federal Republic of Germany. o Tests based on DHHS guidelines (Department of Health and Human Services) where applicable.

Warning F1G11U1M1

Use of unreleased accessories or system modifications and changes are prohibited and can lead to system malfunctions. This can result in injury to the patient and/or damage to the equipment! u Only accessories released by Siemens for use with this product may be used.

Software

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The system and user software used in this product is protected by copyright.

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Safety

Equipotential bonding

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Products for which equipotential bonding is required may only be operated in medical facilities where supplemental equipotential bonding has been installed and tested according to the specifications in DIN VDE 0107 for Germany or relevant country-specific regulations.

Warning Electric shock to operator and patient F1G6U2M2

Contact voltages during use of the system in cardiac or RF surgery can cause injury to the patient and/or operator u The SIREMOBIL Compact L system can be connected to a protective ground terminal via an equipotential bonding connection located on the C-arm chassis.

Electromagnetic compatibility

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This medical product complies with the requirements of the applicable standard on electromagnetic compatibility (EMC). However, we wish to inform you that other mobile electronic devices such as radio telephones (mobile phones) exceed the radiation limits specified in the EMC standard and can therefore disturb functions of your medical device. (→ see "Technical Specification" chapter)

Use in connection with high frequency

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The following regulations for use must be observed: o IEC/TR 1289-1/07.94/ High frequency surgical equipment - Part 1: Operation High frequency surgical equipment - Part 1: Operation o IEC/TR 1289-2/08.94/ High frequency surgical equipment - Part 2: Maintenance High frequency surgical equipment - Part 2: Maintenance

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Safety

Maintenance and inspection

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Prior to an examination, the user must make sure that all safety-relevant parts of the system are functioning properly and that the system is ready for operation. F1G10U1M1, F1G10U2M1

Caution Mechanical and/or electrical wear and lack of maintenance. The safety of patients, operating personnel and third parties can be endangered. u The system is subject to mechanical and electrical wear and tear. In the interest of the safety of patients, operators and third parties, it is recommended that the operating safety and function of the equipment be maintained by inspections every 12 months. u If you do not have a service contract, contact Siemens Customer Service.

Please observe the relevant statements in the "Maintenance" register. F2G5U7M1, F1G14U1M1

Caution Mechanical damage and damage to the system electrics due to improper use and excessive load on the system. Possible injury to operating personnel, patients or third parties and damage to the product. u The operating personnel must be instructed in correct operation. Instruction is to be repeated at appropriate intervals. We recommend simulating emergency conditions during training so that appropriate conduct can be taught. u If necessary, have the system checked more frequently. u Ensure that any damage or defects are repaired professionally without delay.

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