Ziehm Vision series Operating Instructions Oct 2011

Copyright Copyright © 2011 Ziehm Imaging GmbH All rights reserved. Transmission or reproduction of this document, exploitation and disclosure of its contents to third persons is not permitted without express written consent of the manufacturer. Infringements shall entitle to damage claims. Registered Trademarks This document may contain the names of registered trademarks or brands, the use of which by third persons for their purposes may infringe the rights of their respective owners.

Quality Standards This document was produced in accordance with a certified QM system as per DIN EN ISO 13485. It conforms to the requirements of Council Directive 93/42 EEC, Annex I, and other applicable norms. The information provided in this document may be updated at regular intervals. Subject to change without prior notice. Manufactured by: Ziehm Imaging GmbH Donaustr. 31 90451 Nuremberg E-Mail: [email protected] http://www.ziehm.com Rev. 10/2011

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Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

With the system, Ziehm Imaging GmbH provides an active medical device connected to the mains power supply. The above listed medical device is a non-contact device. The accessory is a non-contact accessory. It does not require any contact with the patient to perform its intended use. It provides contactless energy in the form of X-rays.

Preface

Ziehm Imaging GmbH authorizes only trained and skilled personnel to operate this medical device. The system is intended for use by health care professionals such as physicians, orthopedic surgeons, vascular surgeons, neurovascular surgeons, cardiologists, radiologists and technologists in hospitals, outpatient clinics and other clinical environments. Ziehm Imaging GmbH anticipates the system will be used on a nearly daily basis. Ziehm Imaging GmbH applications specialists and/or qualified site personnel provide on-site operator training in the proper use of the system. The medical equipment is intended for fluoroscopies in the field of surgery, e.g. in traumatology, orthopedics, neurology, urology, cardiology. Its motorized movements enable the surgeon to exactly position the system. Its automatic or manual isocentric image acquisition technique enables fluoroscopies of any kind as well as 3D imaging (as an option) in the field of interventional surgery. It assists the surgeon in intraoperative assessment of the anatomical situation or outcome of the surgical procedure by means of optional 3D images and user-definable slice views (axial, sagittal, coronal).

Normal use

The NaviPort option is an interface enabling the connection of third-party navigation systems approved by Ziehm Imaging GmbH to the Ziehm Vision Vario 3D and Ziehm Vision FD Vario 3D. Third-party devices and components used in combination with this system must comply with the safety requirements according to IEC 60601-1 and/or IEC 60601-1-1 or furnish proof of an equivalent degree of safety. To ensure CE conformity, these components must have a CE approval in accordance with Council Directive 93/42/EEC. In addition, a declaration in compliance with Article 12 of the said directive must be provided. For components without CE approval, a conformity assessment procedure is obligatory. Proper and safe operation of the system requires adequate transportation, storage, assembly and installation as well as appropriate use and maintenance. The limit values indicated in the present document must not be exceeded; this applies also when putting the system into service. The system is suitable for interventional procedures according to IEC 60601-2-43. The exposure of humans to ionizing radiation must always be medically justified. Especially when used on pregnant women, adolescents, children, and pediatric patients, all procedures using ionizing radiation should be used with caution or be avoided altogether. However, the final decision lies with the attending physician or attending surgeon.

Contraindications to the use of X-rays

The system may only be operated by personnel who has undergone radiological training.

Operation

In the USA, Federal law restricts use of this device to trained personnel on the order of a physician.

Operation (USA)

Only authorized personnel are allowed to assemble and/or repair the medical equipment described in this document. Authorized personnel are persons who have attended an appropriate training course provided by the manufacturer.

Authorized personnel

The manufacturer accepts responsibility for the safety, reliability and performance of the system only if

Exclusion of liability



any installation, modification or repair work is carried out exclusively by persons authorized by the manufacturer;



the electrical installation of the site where the system is operated complies with the requirements of VDE 0107 or the corresponding national regulations of the country of installation;



only original spare parts or components that comply with specifications determined by Ziehm Imaging GmbH are used;



the system is used in accordance with the Operating Instructions.

The warranty becomes invalid in case that any repair, modification or installation work is carried out by unauthorized personnel, or any seals on components are broken. No consequential damages will be accepted either.

Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

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The equipment conforms to Class IIb according to Council Directive 93/42/EEC. This document has been written and reviewed originally in German and translated.

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Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

Contents Contents

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1

General Information 1.1 Typographical conventions... 1.2 Conventions for safety instructions ...

2

System Overview 2-1 2.1 Fields of application... 2-1 2.2 Features ... 2-2 2.3 Options ... 2-4 2.4 Optional accessories ... 2-5 2.5 Optional accessories (USA) ... 2-5 2.6 X-ray protective equipment ... 2-6 2.7 Parts of the system... 2-6 2.7.1 C-arm stand ... 2-6 2.7.2 Monitor cart ... 2-7 2.7.3 Screen assignment ... 2-9 2.7.4 Video outputs ... 2-10

3

Safety Instructions 3-1 3.1 General safety instructions... 3-1 3.2 X-rays ... 3-2 3.3 Electromagnetic compatibility... 3-4 3.4 Protective grounding ... 3-4 3.5 Equipotential grounding... 3-4 3.6 Laser radiation... 3-5 3.7 Temperature... 3-7 3.8 Printers ... 3-7 3.9 System failure... 3-9 3.10 Mechanics ... 3-10 3.11 Operator errors... 3-12

4

Mechanical Handling 4.1 Transport position... 4.1.1 C-arm stand transport position... 4.1.2 Monitor cart transport position... 4.2 Braking and steering the monitor cart ... 4.3 Braking and steering the C-arm stand... 4.4 C-arm movements... 4.4.1 Orbital rotation ... 4.4.2 Angulation ... 4.4.3 Swiveling (panning)... 4.4.4 Horizontal movement ... 4.4.5 Vertical movement ... 4.5 Vision Center Movements ...

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1-1 1-3 1-3

4-1 4-1 4-2 4-4 4-5 4-6 4-8 4-9 4-11 4-13 4-15 4-17 4-18

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Contents

5

Controls 5.1 Control panel ... 5.1.1 Elements of the control panel... 5.1.2 Controls in the Fluoroscopy and Vascular operating modes... 5.1.2.1 SmartArchive function... 5.1.3 Buttons in the Ziehm SmartEye with SmartControl ... 5.1.4 Operating mode selection ... 5.1.5 Alphanumeric keypad... 5.2 Buttons and switches on the unit... 5.3 Hand switch and foot switch ... 5.4 Mouse with mousepad...

5-1 5-1 5-1 5-2 5-7 5-8 5-10 5-12 5-13 5-14 5-16

6

Laser Positioning Device 6.1 Applications ...

6-1 6-2

7

Switching the System On and Off 7.1 Preparing the system... 7.2 Switching the system on and off... 7.3 EMERGENCY STOP button... 7.4 Key switch ...

7-1 7-1 7-2 7-4 7-5

8

Standard Fluoroscopic Operations 8.1 Overview... 8.2 Motor-driven C-arm positioning ... 8.3 Fluoroscopy modes ... 8.3.1 Pulsed fluoroscopy ... 8.3.2 Digital radiography (snapshot) ... 8.3.3 Dose reduction ... 8.4 Manual exposure rate setting ... 8.5 Object-Detected Dose Control (ODDC) in the Extremities/cervical spine/head and Trunk anatomical programs ... 8.6 Fluoroscopy programs... 8.6.1 Anatomical programs ... 8.6.2 Metal Artifact Correction function ... 8.6.3 Motion function ... 8.6.4 High Quality function ... 8.6.5 Children function ... 8.6.6 Low Dose function (USA only) ... 8.6.7 Automatic Dose Reduction function ... 8.6.8 Automatic Noise Filter Adjustment function... 8.7 Isocentric examinations in Fluoroscopy operating mode... 8.8 Screen display during radiation ... 8.9 Dose area product ... 8.10 Air kerma ... 8.11 Save ... 8.12 Print Live Screen Image ... 8.13 Warning signals and malfunctions... 8.13.1 Permanent warning during radiation ... 8.13.2 Interval warning during radiation ... 8.13.3 Temperature monitoring ... 8.13.4 Error and alert messages ...

8-1 8-1 8-2 8-3 8-3 8-5 8-6 8-6

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8-8 8-9 8-9 8-11 8-11 8-11 8-12 8-12 8-13 8-13 8-14 8-20 8-20 8-21 8-21 8-23 8-24 8-24 8-24 8-25 8-25

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Contents

9

Isocentric Examinations in Iso Cine and 3D Operating Mode 9.1 Defining the scan center... 9.2 Collision check ... 9.3 Performing the scan ... 9.4 3D views (Ziehm Vision Vario 3D)... 9.4.1 3D reconstruction ... 9.4.2 Viewing options ... 9.4.3 Controls in the 3D menu ...

9-1 9-2 9-11 9-15 9-20 9-20 9-24 9-30

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NaviPort (n/a for USA)

10-1

11

Adjusting Live Images 11-1 11.1 Overview ... 11-1 11.2 Filters... 11-2 11.2.1 Recursive filter ... 11-2 11.2.2 Edge filter ... 11-4 11.2.3 LIH filter... 11-5 11.3 Contrast and brightness adjustment of images in the Ziehm SmartEye (windowing) ... 11-6 11.4 Electronic image magnification... 11-8 11.5 Collimation... 11-9 11.5.1 Iris collimator ... 11-9 11.5.2 Slot collimator ... 11-9 11.6 Image Swapping... 11-11 11.7 Image reversal and image rotation... 11-11 11.7.1 Horizontal and vertical image reversal ... 11-12 11.7.2 Image rotation ... 11-12 11.8 Grayscale Inversion... 11-13

12

Data Management in Non-Isocentric Operating Mode 12-1 12.1 Organization of patient and image data ... 12-1 12.1.1 Patient folders ... 12-1 12.1.2 System-generated patient folders ... 12-2 12.2 Managing patient data... 12-2 12.2.1 Managing patient data securely (HIPAA) ... 12-4 12.2.2 Creating a new patient folder ... 12-9 12.2.2.1 Entering patient data manually ... 12-9 12.2.3 Editing patient data ... 12-10 12.3 Managing image data... 12-12 12.3.1 Managing patient folders... 12-13 12.3.1.1 Marking patient folders ... 12-14 12.3.1.2 Deleting patient folders ... 12-15 12.3.1.3 Inverting the entire archive ... 12-16 12.3.1.4 Saving patient folders ... 12-16 12.3.2 Finding and displaying a patient folder... 12-18 12.3.3 Activating a patient folder... 12-20 12.3.4 Browsing through the active patient folder ... 12-22 12.3.5 Processing and outputting images in a patient folder ... 12-23 12.3.5.1 Displaying an image at full size ... 12-25 12.3.5.2 Marking images ... 12-25 12.3.5.3 Protecting images ... 12-26 12.3.5.4 To delete images ... 12-27 12.3.5.5 Printing on video printer... 12-28

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Contents

12.3.6 12.3.7 12.3.8

12.3.5.6 Saving images ... 12-29 12.3.5.7 Dose protocol details ... 12-31 Comparing saved images... 12-31 Delete selection... 12-32 Making backup copies of patient folders ... 12-34 12.3.8.1 Backup to USB storage medium... 12-35 12.3.8.2 To CD/DVD ... 12-37

13

Data management in isocentric operating mode 13-1 13.1 Settings... 13-3 13.2 Searching for patient folders... 13-7 13.3 Activating a patient folder ... 13-8 13.3.1 Iso Cine ... 13-9 13.3.2 3D reconstruction (Ziehm Vision Vario 3D only) ... 13-12 13.3.3 Screenshot (Ziehm Vision Vario 3D only) ... 13-14 13.4 Delete data ... 13-15 13.5 Import patient folders from a CD/DVD... 13-16 13.6 Write data to CD/DVD ... 13-18 13.7 Importing patient folders from a USB stick ... 13-19 13.8 Saving data to a USB stick ... 13-20 13.9 Transferring data to the DICOM server with DICOM Storage ... 13-21 13.10 Printing data ... 13-22

14

DICOM Functions 14-1 14.1 Prerequisites... 14-1 14.2 Downloading patient data from a DICOM server... 14-1 14.2.1 Query ... 14-1 14.2.2 Downloading a Worklist... 14-2 14.2.2.1 Downloading a Worklist for a specific time span... 14-3 14.2.2.2 Downloading a patient-specific Worklist ... 14-5 14.2.2.3 Downloading a Worklist for a procedure step ... 14-6 14.3 Processing scheduled procedure steps of a Worklist (MPPS) ... 14-7 14.4 Saving all images from one or several patient folders... 14-10 14.5 Saving and printing images and cine loops from a patient folder ... 14-11 14.6 Saving or printing single cine loop images ... 14-13 14.7 Importing images and cine loops from a DICOM server... 14-14 14.8 Storage Commitment... 14-18 14.9 Isocentric operating mode ... 14-19 14.9.1 DICOM settings ... 14-19 14.9.2 Transferring data to the DICOM server with DICOM Storage ... 14-21

15

Cine Loops 15-1 15.1 Overview... 15-1 15.2 Generating a cine loop ... 15-1 15.3 Opening a saved cine loop ... 15-3 15.4 Controlling and editing a cine loop during playback ... 15-6 15.5 Processing and outputting saved cine loops ... 15-8 15.5.1 Replaying a cine loop ... 15-9 15.5.2 Marking cine loops ... 15-10 15.5.3 Protecting cine loops ... 15-10 15.5.4 Deleting cine loops ... 15-11 15.5.5 Printing on video printer ... 15-12 15.5.6 Saving cine loops ... 15-13

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Contents

15.6 Processing and outputting single cine loop images ... 15-15 15.6.1 Marking cine loop images ... 15-16 15.6.2 Protecting cine loop images ... 15-17 15.6.3 Deleting cine loop images ... 15-17 15.6.4 Printing cine loop images on the video printer ... 15-18 15.6.5 Saving cine loop images ... 15-20 16

Vascular Operating Mode 16-1 16.1 Overview ... 16-1 16.2 Motor-driven C-arm positioning ... 16-3 16.3 Isocentric examinations in Fluoroscopy operating mode ... 16-3 16.4 Acquiring a DSA cine loop... 16-9 16.5 Generate Multi Frame RSA ... 16-11 16.6 Generate Single Frame RSA... 16-12 16.7 Acquiring an MSA image... 16-13 16.8 Acquiring an RSA image ... 16-13 16.9 Generating an MSA image or RSA image automatically... 16-14 16.10 Generating MSA and RSA images from a saved DSA cine loop ... 16-16 16.10.1 Opening and postprocessing a DSA cine loop in an active patient folder ... 16-16 16.10.2 Opening and postprocessing a DSA cine loop from any patient folder ... 16-17 16.11 Editing a DSA cine loop... 16-19 16.12 Pixel shift ... 16-20 16.13 Landmarking... 16-21

17

Post-Processing Images 17-1 17.1 Overview ... 17-1 17.2 Activating the post-processing functions ... 17-3 17.3 Contrast and brightness adjustment of individual images (windowing)... 17-4 17.4 Edge filter ... 17-6 17.5 Digital zoom... 17-7 17.6 Grayscale inversion... 17-8 17.7 Image rotation ... 17-8 17.8 Horizontal and vertical image reversal ... 17-9 17.9 Digital collimation (image crop) ... 17-9 17.10 Marking and deleting images ... 17-10 17.11 Outputting post-processed images... 17-12

18

Measurement 18-1 18.1 Measuring functions ... 18-1 18.2 Calibrating ... 18-3 18.3 Measuring a length or distance ... 18-5 18.4 3-point measurement ... 18-8 18.5 4-point measurement ... 18-11 18.6 4-point ratio measurement ... 18-14

19

Displayed Texts and Text Functions 19.1 Overview ... 19.2 Image information on the screen... 19.2.1 Upper left corner of the screen... 19.2.2 Upper right corner of the screen ... 19.2.3 Lower left corner of the screen...

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19-1 19-1 19-1 19-1 19-1 19-2

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Contents

19.2.4 Lower right corner of the screen... 19-3 19.3 Entering and editing text... 19-4 20

Direct Radiography 20.1 Overview... 20.2 Fitting the film cassette holder... 20.3 Making a direct radiographic exposure...

21

System Configuration 21-1 21.1 Overview... 21-1 21.2 User settings... 21-3 21.2.1 Autotransfer... 21-3 21.2.2 Autostore ... 21-3 21.2.3 Image Swap with Save... 21-4 21.2.4 Displaying a crosshair ... 21-5 21.2.5 Defining the start screen ... 21-7 21.2.6 Navigation ... 21-8 21.2.7 Discarding the operation settings ... 21-8 21.3 Basic settings ... 21-9 21.3.1 Setting the system date and the system time... 21-9 21.3.2 Selecting the live screen ... 21-10 21.3.3 Entering the hospital data ... 21-10 21.3.4 Discarding the basic settings... 21-11 21.4 Cine/DSA/Dose ... 21-12 21.4.1 Cine loop settings... 21-12 21.4.2 Showing or hiding the native image ... 21-13 21.4.3 MSA Autotransfer ... 21-14 21.4.4 DSA CO2 ... 21-15 21.4.5 RSA direct ... 21-15 21.4.6 Discarding the cine loop and subtraction mode settings ... 21-16 21.5 Storage media ... 21-17 21.5.1 Defining the USB storage medium format... 21-17 21.5.2 Defining the CD/DVD storage format ... 21-18 21.5.3 Deleting data from storage media ... 21-19 21.5.4 DICOM storage server ... 21-19 21.5.5 Quick Cine Export ... 21-20 21.6 Setting the flat-screen monitors... 21-22 21.6.1 Flat-screen monitors of type 1... 21-23 21.6.2 Flat-screen monitors of type 2... 21-28 Appendix A A.1 Regular checks... A.1.1 Routine checks to be performed by the owner/operator ... A.1.2 Consistency test according to national regulations ... A.1.2.1 Performing a reference measurement ... A.1.2.2 Consistency test... A.1.3 Checking the computed Air Kerma dose values ... A.1.4 Dose meter check (n/a for USA) ... A.1.5 Checking the computed dose values ... A.1.6 Checking the useful beam... A.1.7 Leakage in the cooling system ... A.1.8 Gettering the image intensifier tube (n/a for Ziehm Vision FD Vario) A.1.9 Operator’s log... A.1.10 Gain adjustment and pixel correction (Ziehm Vision FD Vario)...

VI

20-1 20-1 20-1 20-2

A-1 A-1 A-1 A-2 A-3 A-3 A-4 A-4 A-5 A-5 A-7 A-7 A-7 A-7

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Contents

A.2

Cleaning, disinfection, sterilization ... A.2.1 Cleaning ... A.2.2 Disinfection ... A.2.3 Sterilization ... Malfunctions ... A.3.1 Types of malfunctions ... A.3.1.1 Alerts during power-up... A.3.1.2 Errors during power-up ... A.3.1.3 Alerts during operation... A.3.1.4 Errors during operation ... A.3.2 Error and alert messages... A.3.2.1 List of error and alert messages on the C-arm stand control panel ... A.3.2.2 List of error and alert messages on the Vision Center/reference screen in patient data management of isocentric operating mode... A.3.3 Mains fuse... Labels... Labels (USA) ... Labels for foot switch... Focal spot position ... A.7.1 Ziehm Vision Vario ... A.7.2 Ziehm Vision FD Vario ... Heat capacity... Scattered radiation in the significant zone of occupancy ... A.9.1 Ziehm Vision Vario ... A.9.2 Ziehm Vision FD Vario ... Dimensions... Technical Data ... A.11.1 Systems with a voltage rating of 100 V, 120 V, 200 V ... A.11.2 Systems with a voltage rating of 220 V, 230 V, 240 V ... Laser Positioning Device... Dose meter...

A-22 A-25 A-26 A-38 A-48 A-49 A-49 A-50 A-51 A-52 A-52 A-53 A-54 A-57 A-59 A-62 A-65 A-65

Appendix B B.1 Attaching sterile disposable covers to the C-arm ...

B-1 B-1

Appendix C C.1 Approved third-party devices...

C-1 C-1

A.3

A.4 A.5 A.6 A.7 A.8 A.9 A.10 A.11 A.12 A.13

Index

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A-8 A-8 A-8 A-9 A-10 A-10 A-10 A-10 A-10 A-11 A-12 A-12

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1

General Information

These Operating Instructions are designed to enable owners and operators of the system to operate the systems described herein safely and efficiently. Ziehm Vision Vario, Ziehm Vision FD Vario, Ziehm Vision Vario 3D, Ziehm Vision FD Vario 3D, Ziehm Vision FD Vario 3D, image memory: software version 5.30.2 or higher, Vario: RoboC software version 5.62 or higher.

Scope of validity of these Operating Instructions

All illustrations are examples only, and may differ from the actual situation. NOTE Unless stated otherwise, all information given here for the Ziehm Vision Vario also refers to the following systems:  Ziehm Vision FD Vario  Ziehm Vision Vario 3D  Ziehm Vision FD Vario 3D If differing features only depend on whether the system provides 3D views or not, these Operating Instructions will differentiate between the Ziehm Vision Vario and the Ziehm Vision Vario 3D only. In this case, Ziehm Vision Vario stands for the following systems:  Ziehm Vision Vario  Ziehm Vision FD Vario Ziehm Vision Vario 3D stands for the following systems:  Ziehm Vision Vario 3D  Ziehm Vision FD Vario 3D Statements made in these Operating Instructions also apply to the following systems:  Ziehm Vision² Vario  Ziehm Vision² Vario 3D  Ziehm Vision² FD Vario  Ziehm Vision² FD Vario 3D

Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

1-1

1 General Information

NOTE If differing features only depend on whether the system is equipped with an image intensifier or a flat-panel detector, these Operating Instructions will differentiate between the Ziehm Vision Vario and the Ziehm Vision FD Vario only. In this case, Ziehm Vision Vario stands for the following systems with an image intensifier:  Ziehm Vision Vario  Ziehm Vision Vario 3D On the other hand, the Ziehm Vision FD Vario stands for the following systems with a flat-panel detector:  Ziehm Vision FD Vario  Ziehm Vision FD Vario 3D The present Operating Instructions describe a system with maximum configuration. The system configuration chosen by you may not contain all options and functions described here. Separate operating instructions

For several system options, separate operating instructions may be available. They are supplied with the system, provided that the system configuration includes the respective option. You will find a corresponding reference to those operating instructions in the relevant sections of this document.

Environmental compatibility

The Ziehm Vision Vario, Ziehm Vision FD Vario, Ziehm Vision Vario 3D, and Ziehm Vision FD Vario 3D systems do not produce any waste during operation. When the system has reached the end of its useful service life, the relevant waste disposal regulations of the country of installation must be observed. Ziehm Imaging GmbH takes back your devices and undertakes to dispose of them appropriately in accordance with national regulations. If you want to return a device, please contact the Service department of Ziehm Imaging GmbH.

Life cycle/ Spare parts supply

1-2

The useful service life defined for this medical device is seven years. For this period and beyond, up to a time frame of 10 years, Ziehm Imaging GmbH ensures that spare parts can be supplied after product discontinuation. Due to technical progress, Ziehm Imaging GmbH reserves the right to check whether the technology used is appropriate, and if applicable, ensures to provide compatible alternative solutions.

Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

1 General Information

1.1

Typographical conventions

In this document, the following notations and formats are used to highlight certain elements of the control panel or the documentation itself: Element

Format

Example

Vision Centerelements (buttons and boxes), operating modes, functions, modes

Bold

Fluoro

Cross-references

Italic, preceded by an arrow

 Ch. 21, p. 21-1

Procedure steps

Preceded by a 

 Press the OK button.

Text input

Courier, bold

Administrator

Table 1-1

Notations and formats used in this document

1.2

Conventions for safety instructions

The present document does not constitute a complete catalog of all safety measures necessary for the operation of the respective medical equipment, since special operating conditions may require further measures. However, it does contain instructions which must be observed in order to ensure the personal safety of operating staff and patients as well as to avoid damage to property. These instructions are highlighted as follows: DANGER DANGER indicates a hazardous situation which, if not avoided, will result in death or serious injury.

WARNING WARNING indicates a hazardous situation which, if not avoided, may result in death or serious injury.

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1 General Information

CAUTION CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE NOTICE indicates a property damage message. NOTE Notes are merely informative. Additional useful information and hints are provided for the operator here.

1-4

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System Overview

2.1

Fields of application

The Ziehm Vision Vario and Ziehm Vision Vario 3D are mobile C-arm Xray image receptors which are suitable for all surgical applications in traumatology, orthopedics, neurosurgery , urology and cardiology as well as for use in gastroenterology, all vascular applications and endoscopy.

Ziehm Vision Vario and Ziehm Vision Vario 3D

The Ziehm Vision Vario 3D differs from the Ziehm Vision Vario by providing additionally 3D views. These 3D views are generated by means of a filtered back projection (FBP) algorithm. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart.

Differences between Ziehm Vision Vario and Ziehm Vision Vario 3D

The fully-digital Ziehm Vision FD Vario and Ziehm Vision FD Vario 3D are designed for demanding, high-precision vascular applications, e.g. in the field of neurology. As these systems are distortion-free, they are especially suitable for afterloading treatment planning and navigation.

Ziehm Vision FD Vario and Ziehm Vision FD Vario 3D

The Ziehm Vision FD Vario 3D differs from the Ziehm Vision FD Vario by providing additionally 3D views. These 3D views are generated by means of a filtered back projection (FBP) algorithm. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart.

Differences between Ziehm Vision FD Vario and Ziehm Vision FD Vario 3D

The systems are intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients. The systems can be used for the whole human body without restriction (e.g. organs, tissue, bones, implants) depending on the medical indication. In order to user the monitors as image display devices of a certain application category, you must inspect them according to the legal regulations (DIN V 6868-57).

Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

Application categories of image display devices

2-1

2 System Overview

2.2

Features

Variable scan center

The freely selectable position of the scan center enables the surgeon to define the scan center in certain areas without having to move the patient.

3D reconstruction

It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions.

Mobility

With its compact design and combined steering & braking system, the systems offer unrestricted mobility at the operating table, even if space is scarce. The easy adjustability of the C-arm and the excellent counterbalancing of the systems make it possible to access even the most difficult positions.

Anatomical programs

Computer-controlled anatomical programs ensure optimum exposure rate and image quality control as well as high operating comfort. A ‘Soft’ program for soft tissue visualization during object localization and a ‘Metal’ program for suppressing image flare resulting from the use of metal implants and surgical instruments complete the automatic functions.

Radiation dose reduction

The superior penetration capabilities of the digital high-frequency generator enable a significant reduction in the patient skin dose. Radiation-free collimation is provided by the system’s ‘Virtual Collimator’.

Image quality

18" flat-screen monitors guarantee flicker-free images. The advanced Full Frame Technology, which uses non-interlacing throughout the entire image processing chain, generates noise-free images without motion artifacts, even if the subject has moved.

Ziehm Vision FD Vario

The Ziehm Vision FD Vario features a fully-digital image processing chain. The digital flat-panel detector ensures distortion-free images.

Image adjustment

Comprehensive real-time image processing functions (customizable noise and area filtering, electronic contrast and brightness adjustment, zooming, radiation-free horizontal and vertical image reversal, digital image rotation) ensure perfect adaptation of the image quality and orientation on the screen to the surgeon’s needs. Further image processing functions are available for saved images (post-processing).

Advanced Active Cooling

2-2

The Advanced Active Cooling system allows for nearly unlimited fluoroscopy times, being often indispensable e.g. in cardiac and vascular surgery or endoscopic applications.

Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

2 System Overview

A patient-based image management system providing a 16-image mosaic view and menu-controlled user guidance guarantees efficient image data handling.

Image management

For documentation purposes, a video printer is available.

Documentation and output

For filmless archiving, the following devices are available:  DVD writer  USB port Images can be stored in the following formats:  PC-compatible TIF format  PC-compatible JPG format with reduced resolution and reduced color depth  DICOM format  DICOM format with reduced resolution and reduced color depth  Multimedia format: AVI (CD/DVD) The system documents not only patient-related data, but also imagerelated data (e.g. the fluoroscopy parameters). In addition, all systems have a video output. The optional DICOM 3.0 interface (Ziehm NetPort) enables integration into any network supporting DICOM, e.g. PACS. Thanks to ‘Primary Capture’ support, the original fluoroscopic images can be archived without the changes which may have been applied to them later. The following DICOM classes are supported: Print, Storage (including multiframe capability), Storage Commitment, Media, Worklist, MPPS, Query/ Retrieve and Verification.

Networkability

It is possible to connect and configure several DICOM servers for each DICOM Class. For more information on DICOM, please refer to our DICOM Conformance Statement included in the corresponding Service Manual. The optional Ziehm NaviPort interface is an interface, enabling the integration of 3D navigation systems from different manufacturers.

Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011

Ziehm NaviPort

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2 System Overview

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Options The present Operating Instructions describe a system with maximum configuration. The system configuration chosen by you may not contain all options and functions described here. The following options can be integrated into the system or supplied upon request:  Vascular Plus Package (DSA, MSA, RSA, Pixel Shift, Landmarking including cine loops with 12.5 frames/s, 15 frames/s for USA, respectively 12.5 frames/s on system with flat-panel detector, Dual Plus foot switch)  Vascular Advance Package (includes the Vascular Plus Package option including cine loops with 25 frames/s, 30 frames/s for USA, respectively 25 frames/s on system with flat-panel detector, measuring functions)  31 cm image intensifier  Vertical movement expansion of the C-arm by 20 cm (n/a for 31 cm image intensifier, n/a for USA)  Integrated dose meter for measuring the dose area product  Laser positioning device on the generator  Wireless LAN (n/a for USA)  NaviPort (only in combination with DICOM 3.0 interface; n/a for USA)  EMERGENCY STOP button  Dual Plus foot switch  Connection for external separate radiation indication lamp (including software)  DVD writer  External 18" flat-screen monitor  Video printer Sony® UP-970 (for printout on paper) or UP-990 (for printout on paper or transparent film)  2 additional video connections for external flat-screen monitors (right and left monitor)  external 50 Hz video connection  Measuring functions  Subtraction modes: DSA, MSA, RSA  Pixel shift and landmarking  DSA function for visualization with CO2 as contrast medium  User administration (HIPAA)  Cine loop with  1/2/4/8/12.5/25 fps for systems with flat-panel detector

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Ziehm Vision Vario P_28250/CD_28251_EN-14/10/2011