ARCADIS Varic Operator Manual VB 13 C Feb 2006

Operator Manual ARCADIS Varic VB 13 C

SP

The original language of this document is German.

© Siemens AG 2006 All rights reserved

Contact address Siemens AG Wittelsbacherplatz 2 D-80333 München Germany

Siemens AG, Medical Solutions Special Systems Henkestraße 127 D-91052 Erlangen Germany

SP SPR2-310.620.01.03.02 Printed in Germany AG 02/06

ARCADIS Varic Overall Table of Contents Lists

Operator Manual

Overall Table of Contents Register 1: Safety General safety information... 3 Personal safety ... 16 Equipment safety... 24

Register 2: System Description Description of functions... 3 Operation ... 9

Register 3: Patient Data Introduction to patient registration... 3 Emergency registration... 5 Registering a new patient ... 9 Registering a known patient ... 13 Patient registration configuration ... 19 Introduction to the Patient Browser... 25 Searching for and displaying patient data ... 29 Updating and deleting data ... 35 Patient Browser configuration ... 49

Register 4: Examination Safety information relating to the examination procedure ... 3 The Examination task card ... 5 Performing an examination ... 9 References task card ... 21 Displaying reference images... 25 Native task card ... 29 Displaying native images ... 30 Reports ... 33

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ARCADIS Varic Overall Table of Contents

Register 5: Viewing Introduction... 3 Loading and displaying images ... 13 Scrolling and selecting images... 19 Editing images ... 33 2D Evaluation (option) ... 47 DSA Evaluation ... 57 Saving, transferring, documenting, closing images ... 61 Viewing configuration ... 69

Register 6: Filming/Printing and Archiving Introduction to filming/printing ... 3 Automatic/manual filming ... 9 Viewing and processing film sheets and images... 17 Changing film settings for a film job ... 33 Controlling data transfer... 43 Configuration for filming/printing ... 51 Introduction to archiving ... 63 Archiving data ... 67 Exporting data ... 71 Import/export in the file system... 79 Controlling data transfer... 85 Configuration for archiving ... 91

Register 7: Configuration Examination configuration... 3

Register 8: Technical Description Curves and diagrams ... 3 Technical data ... 9 Labels ... 13

Register 9: Maintenance Functional and safety checks... 3 Service support via network connection... 6 Cleaning and disinfection ... 9

Register 10: Accessories Accessories... 3 Cassette exposure ... 11

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SiemensSP04Cs2

Operator Manual ARCADIS Varic Safety SP

08.03

SPR2-310.620.01.03.02 Cs2

, 7777

SP MSVersion 04

EnglishEnglish

Please observe the Safety register This must be studied thoroughly before system startup.

The original version of this Operator Manual was written in the German language.

© Siemens AG 2006 All rights reserved

Siemens AG, Wittelsbacherplatz 2, D-80333 München, Germany Contact information: Siemens AG, Medical Solutions, Special Systems Henkestraße 127, D-91052 Erlangen, Germany

Order no.: SPR2-310.620.01.03.02 Printed in Germany AG 02/06

SP

Table of Contents General safety information Information about this Operator Manual... 3 Warnings... 4 General information... 4 Information about correcting errors... 5 Names and parameters... 5 Laws and regulations... 6 Validity... 6 Software... 7 Equipotential bonding... 7 Electromagnetic compatibility... 8 Use in connection with high frequency... 8 Maintenance and check... 9 Malfunctions... 10 Error messages at the C-arm system... 10 System messages on the monitor... 11 Malfunction of electrics... 12 Switching to emergency power supply... 12 Disconnecting the power supply plug... 12 Emergency STOP... 13 Fire protection... 14 Explosion protection... 14 Overload protection... 15

Personal safety Open heart and skull examinations... 16 Crushing hazards on the C-arm system... 16 Crushing hazards on the monitor trolley... 18 Mechanical damage... 18 Radiation protection... 19 Location and size of the relevant operating area... 20 Maximum scatter radiation in the operating area... 21 Radiation interruption for all operating modes... 23

Equipment safety Positioning the C-arm... 24 Installation, repair... 24 Original accessories... 25 Combination with other products/components... 25 Attachment of dedicated options... 26 General safety requirements... 26 Tilting resistance; mechanical strength; central ray migration... 26 Attachment... 26 Attenuation equivalent... 27 Weight counterbalance... 27 Image quality... 27 Electromagnetic compatibility... 27 Additional safety information... 28 Disposal... 28

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Operator Manual SPR2-310.620.01.03.02

Safety

General safety information Information about this Operator Manual Proper use of this equipment presupposes that the operating personnel are 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: ❏ Safety information ❏ Functional and safety checks ❏ Personal safety ❏ Equipment safety The operating personnel must be instructed in the proper operation of the equipment. Training must be repeated as required at appropriate intervals. We recommend simulating emergency conditions during training so that appropriate corrective measures can be taught.

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Safety

Warnings Warning

Warning is used to indicate the presence of a hazard which can cause personal injury or death.

WARNING At first the source of danger is stated. Then possible consequences are pointed out. ◆ In conclusion you receive information on how to rule out any danger.

Caution

Caution is used to indicate the presence of a hazard which can cause damage to the equipment if this is used improperly.

CAUTION At first the source of danger is stated. Then possible consequences are pointed out. ◆ In conclusion you receive information on how to rule out any danger.

General information Note

Note is used to notify users of operator information which is important but not hazard-related.

Notes are marked with an exclamation mark “ !” and printed in italics.

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Safety

Information about correcting errors 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 source of error is described. ◆ Perform these operating steps to solve the problem.

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

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Laws and regulations 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. In all countries, the legally established regulations are to be observed. 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. 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.

Validity This Operator Manual applies to the following product: ❏ ARCADIS Varic

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Safety

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

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

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. ◆ Make sure all necessary precautions are taken (with the existing level of security) when changing a functionality or factory-set configuration.

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

Equipotential bonding 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 or the relevant country-specific regulations.

Electromagnetic compatibility This medical device complies with the requirements of the applicable standard on electromagnetic compatibility (EMC).

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Safety

(→ see Operator Manual “Information on electromagnetic compatibility”) 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 The following regulations for use must be observed: ❏ IEC/TR 1289-1/07.94/ High frequency surgical equipment - Part 1: Operation High frequency surgical equipment - Part 1: Operation ❏ 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 check 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. Wear and tear

The system is subject to mechanical and electrical wear and tear. In the interest of the safety of patients, operating personnel and third persons, maintenance and safety checks must be carried out every 12 months to maintain the operational safety and reliability of the product.

Please observe the relevant information in the (→ Register 9: Maintenance)

CAUTION Mechanical damage and damage to the system electrics due to improper use and excessive load on the system. Injury to operating personnel, patients or third persons and damage to the product. ◆ If necessary, have the system checked more frequently. ◆ 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.

To ensure optimal image quality, have the following functions checked in particular as part of regular maintenance: Pixel shift, image rotation, noise reduction, edge enhancement, subtraction, Roadmapping. Performing maintenance

Maintenance work should be performed by trained technical personnel only. If you do not have a maintenance contract, please contact Siemens Customer Service. If national laws or regulations specify more frequent checking and/or maintenance, this must be observed.

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Safety

Malfunctions In the event of malfunctions of the ARCADIS Varic system, call SIEMENS Customer Service.

Error messages at the C-arm system When a malfunction is detected, the ARCADIS Varic system is disabled. An error message is displayed on the control panel of the C-arm system:

In addition, a malfunction is also displayed on the left monitor: ❏ All vital system functions are automatically checked each time the ARCADIS Varic is switched on. ❏ During routine operation, the ARCADIS Varic is continuously monitored. ❏ Temporary error messages, such as No. 5901, can be canceled by pressing any button on the C-arm system (except lifting column and On/Off button). ❏ Non-temporary error messages, such as No. 5015 or 5016, cannot be canceled. If these errors occur, radiation release is no longer possible. Please notify Customer Service immediately. Error messages 7309 (tube unit iris collimator) and 7409 (TV camera iris) are temporary error messages that can lead to unnecessary radiation exposure of the user and patient if treatment is continued. If errors occur repeatedly, switch off the ARCADIS Varic and notify Customer Service. Have the following information ready: ❏ Error number ❏ Operating mode selected ❏ Was radiation activated when the error occurred? ❏ Is the error related to an operating process?

In case of a malfunction or failure of the radiation indicator, please notify Siemens Customer Service.

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System messages on the monitor Three different types of system messages can appear on the monitor. The type of message is identified by a corresponding symbol (top left). ❏ Example of an error message:

❏ Example of a warning:

❏ Example of information:

You must confirm error messages with the OK button or the radiation release button to be able to resume your work. However, warnings and information do not disable radiation release.

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Malfunction of electrics In case of danger for patients and operating personnel (e.g. if there is no live image on the monitor and the radiation indicator is on despite this) or danger for the product, you must disconnect the power plug immediately. The ARCADIS Varic will be shut down completely and disconnected from the power supply. This will ❏ switch off radiation ❏ abort the current system program ❏ abort and cancel current operating sequences ❏ delete all image information not saved to a hard disk. Only after the cause of the hazard has been clearly identified and remedied may the system be reconnected to the power supply. In all other cases, e.g. system malfunction, contact Siemens Customer Service immediately.

Switching to emergency power supply If a power interruption lasts longer than 8 ms, the ARCADIS Varic can switch off. In this case the ARCADIS Varic must be switched on again after switching to the emergency power supply. In case of a power failure, a signal sounds (up to 10 min.) when the system switches to uninterruptible power supply (UPS).

Disconnecting the power supply plug After disconnecting the power plug, voltage is supplied to the imaging system and the left monitor by the uninterruptible power supply (UPS) until the ARCADIS Varic switches off completely. When the power plug is pulled out, switching to the uninterruptible power supply causes an acoustic signal to be emitted. The UPS switches off after 10 min. at the latest.

As soon as the mains supply is restored, the battery of the UPS is recharged. Please remember that the UPS battery life is limited.

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Safety

Emergency STOP Please immediately press the red EMERGENCY STOP button (arrow) on the electronics unit of the C-arm system when a dangerous situation results from motorized movements.

STOP

❏ Motorized vertical movement is then immediately disabled. ❏ All other system functions remain unaffected by this. Unlock the button only after the danger has clearly been eliminated. ❏ The button can be unlocked by gently turning it clockwise.

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