ARCADIS Varic Operator Manual Feb 2002

ARCADIS Varic 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. SPR2-310.620.30.02.02 | Printed in Germany | © 04.2012, Siemens AG

Legal Manufacturer Siemens AG Wittelsbacherplatz 2 DE-80333 Muenchen Germany

Do you have any notes on this Operator Manual?

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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

ARCADIS Varic SPR2-310.620.30.02.02

Register 1

Introduction

Register 2

Safety

Register 3

System Description

Register 4

Patient data

Register 5

Examination

Register 6

Image Processing

Register 7

Documentation

Register 8

Configuration

Register 9

Technical Data

Register 10

Maintenance

Register 11

Options

Overall Table of Contents

Register 1

Introduction Product application ...3 Information about this Operator Manual...6

Register 2

Safety General safety information ...3 Personal safety ...14 Equipment safety...23

Register 3

System Description Description of functions...3 Operation ...9

Register 4

Patient data Introduction Patient Registration ...3 Emergency registration...5 Registering a new patient...8 Registering a known patient ...12 Configuration of Patient Registration ...18 Introduction Patient Browser ...24 Searching for and displaying patient data ...28 Updating and deleting data ...34 Patient Browser Configuration...48

Register 5

Examination Safety information relating to the examination procedure...3 The Examination task card...5 Performing the examination ...11 References task card ...25 Displaying reference images ...29 Native task card ...33 Displaying native images ...34 Reports ...36

Register 6

Image Processing Introduction...3 Loading and displaying images ...13 Scrolling and selecting images ...19 Editing images ...33 2D Evaluation (option)...47

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Overall Table of Contents

Subtraction processing ...57 Saving, transferring, documenting, closing images ...61 Viewing configuration ...69

Register 7

Documentation Introduction for Filming/Printing ...5 Automatic/manual filming ...11 Viewing and processing film sheets and images...19 Changing film settings for a film job ...33 Checking the data transfer...43 Configuration for filming/printing ...51 Introduction to archiving ...61 Archiving Data...65 Exporting data...68 Import/export in the file system ...75 Checking the data transfer...81 Configuration for archiving ...87

Register 8

Configuration Configuration Examination ...3

Register 9

Technical Data Curves and diagrams ...3 Notes concerning electromagnetic compatibility (EMC)...11 Unit data ...16 Labels ...22

Register 10

Maintenance Functional and Safety Checks...3 Service via network connection ...6 Cleaning and Disinfection ...14

Register 11

Options Accessories ...3 Cassette exposure...20

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Operator Manual SPR2-310.620.30.02.02

Register 1

Introduction

Table of Contents Product application ... 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 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 ... 7 List... 7 Cross-reference ... 7 General notes ... 7 Warning notices... 8 Information about correcting errors ... 8

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Introduction

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Operator Manual SPR2-310.620.30.02.02

Introduction

Register 1

Introduction

We welcome you as a user of the powerful multifunctional ARCADIS Varic C-arm system from Siemens.

Use of the product

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Intended use

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ARCADIS Varic is a mobile X-ray system for intraoperative digital imaging. To name a few, it can be used for trauma, orthopedic, vascular, cardiac and general surgical procedures.

Body region

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Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain therapy, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system is suitable for a large variety of clinical visualizations such as 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, the ARCADIS Varic 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.

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Introduction

Contraindications

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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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The ARCADIS Varic X-ray system is a compact and powerful mobile X-ray image intensifier system with digital image processing for fluoroscopy and radiography. The system is equipped with a foot switch and a hand switch for triggering radiation. The following modes of operation are available for the broad scope of applications ARCADIS Varic: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction/roadmap.

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. Pay special attention 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. 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.

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Operator Manual SPR2-310.620.30.02.02

Introduction

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.

Conditions of use

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The digital X-ray system ARCADIS Varic is a mobile system suitable for use in an OR. When using the system, the applicable country-specific requirements must be observed.

Maintenance, cleaning, and disinfection

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See → Register 10: Maintenance.

Essential performance characteristics

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See → Register 9: Technical Data.

Frequently used operating functions

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❏ System On/Off ❏ Patient registration ❏ Selecting the operating mode ❏ Recording X-ray images ❏ Processing X-ray images (post-processing/adding comments) ❏ Saving/archiving studies locally or to a PACS

Operating functions regarding safety

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❏ Emergency stop function (emergency stop switch) ❏ Radiation protection (collimator function) ❏ Moving the C-arm

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Introduction

Information about this Operator Manual Scope

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This Operator Manual is valid for the following product: ARCADIS Varic

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 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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Operator Manual SPR2-310.620.30.02.02

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 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.

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 notices

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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. Then possible consequences are 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. Then possible consequences are 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 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 SPR2-310.620.30.02.02

Register 2

Safety

Table of Contents General safety information ... 3 Laws and regulations ... 3 Scope... 3 Software ... 4 Equipotential bonding ... 5 Electromagnetic compatibility... 5 Use in connection with high frequency ... 5 Maintenance and inspection ... 5 Malfunctions ... 7 Error messages at the C-arm system ... 7 System messages on the monitor... 8 Saving the log file ... 9 Electrical faults... 10 System failure... 10 Switching to emergency power supply ... 11 Pulling out the power supply plug ... 11 Emergency STOP ... 11 Fire protection... 12 Explosion protection ... 12 Overload protection ... 13

Personal safety ... 14 Open heart and skull examinations... 14 Crushing hazards on the C-arm system ... 14 Crushing hazard on the monitor trolley ... 16 Mechanical damage ... 16 Tube housing temperature ... 17 Radiation protection... 17 Deterministic radiation effect ... 18 Position and extent of the main operating area ... 19 Maximum scatter radiation in the operating area ... 20 Radiation interruption for all operating modes... 22

Equipment safety ... 23 Positioning the C-arm ... 23 Installation, repair... 24 Original accessories ... 24 Combinations with other systems ... 25 Attachment of dedicated options ... 25 General safety requirements ... 25 Tilting resistance; mechanical strength; central ray migration ... 25 Attachment... 25

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Safety

Attenuation equivalent... 26 Weight counterbalance... 26 Image quality ... 27 Electrical safety ... 27 Electromagnetic compatibility ... 27 Additional safety information ... 27 Disposal ... 28

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Operator Manual SPR2-310.620.30.02.02

Safety

Register 2

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. Regulations required by law and the radiation protection regulations must be observed in all countries. Values other than those indicated in this Operator Manual may be programmed where required by local 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. Ensure compliance with all applicable laws and 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

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This Operator Manual is valid for the following product: ❏ ARCADIS Varic

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

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Safety

Software

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

Caution Impermissible or faulty manipulations/modifications to the software or to the connection between the ARCADIS Varic system and the power supply can lead to malfunctioning of the system. Unauthorized access and/or virus attacks possible! ◆ Make sure all necessary precautions are taken (with the existing level of security) when changing a functionality or factory-set configuration. ◆ Make sure that the anti-virus protection is up to date (→ Register 10: Maintenance, Page 7).

Caution Reduced system performance due to overload of the network environment. Unexpected system behavior! ◆ Only use the system in a secure and load-adapted network.

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Operator Manual SPR2-310.620.30.02.02

Safety

Equipotential bonding

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Products for which equipotential bonding is required may only be operated in medical facilities where supplementary equipotential bonding has been installed and tested according to DIN VDE 0107/10.94 Section 4 for Germany or the relevant country-specific regulations.

Electromagnetic compatibility

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This medical device complies with the requirements of the applicable standard on electromagnetic compatibility (EMC). (→ see "Notes regarding electromagnetic compatibility (EMC)" in the Operator Manual) 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.

Use in connection with high frequency

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

Maintenance and inspection

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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.

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