Operating Instructions
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Ziehm Vision Ziehm Vision FD Ziehm Vision R Ziehm Vision² Ziehm Vision² FD Operating Instructions
Ziehm Vision P_26366/CD_28189 - EN-01/06/2013
Copyright Copyright © 2013 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 (Germany) e-mail: [email protected] http://www.ziehm.com Rev. 06/2013
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Ziehm Vision P_26366/CD_28189 - EN-01/06/2013
With the system in its versions Ziehm Vision, Ziehm Vision FD and Ziehm Vision R, 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. 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.
Normal use
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 Ziehm Vision and Ziehm Vision FD endoscopy monitors are not suitable for diagnostic purposes. The system provides contactless fluoroscopy and according to this does not have applied parts.
Normal use (Canada)
The system may only be used in heights up to 6561.7 ft (2000 m) above sea level and must be used within the limits defined by the technical specification. The use of the system is only allowed in rooms used for medical purposes in accordance with EMC class A as well as with protective earth conductor. The system may only be used in an environment with an oxygen saturation of < 25%. The system must be maintained regularly according to the maintenance procedures by qualified personnel authorized by Ziehm Imaging GmbH. The system may only be used in faultless condition and in accordance with the terms set forth by the Operating Instructions. The exposure of humans to ionizing radiation must always be medically justified. Especially on pregnant women, children and adolescents this procedure 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
According to federal laws the system may only be operated by properly trained personnel under the direction of a physician.
Operation (USA)
Only authorized personnel are allowed to assemble the medical equipment described in this document, to put it into service, to install, to maintain and to repair it. Authorized personnel are persons who have attended an appropriate training course provided by the manufacturer.
Authorized personnel
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Exclusion of liability
The manufacturer accepts responsibility for the safety, reliability and performance of the system only if
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. No consequential damages will be accepted either. 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 P_26366/CD_28189 - EN-01/06/2013
Contents Contents
I
1
General Information 1.1 Typographical conventions... 1.2 Conventions for safety instructions ... 1.3 Conventions for norm naming ... 1.4 Conventions for labeling of figures ...
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 ... 2-6 2.5 X-ray protective equipment ... 2-6 2.6 Parts of the system... 2-7 2.6.1 Mobile stand... 2-7 2.6.2 Monitor cart ... 2-10 2.6.3 Screen assignment ... 2-15 2.6.4 Video inputs and outputs ... 2-16
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Safety Instructions 3.1 General safety instructions... 3.2 X-rays ... 3.3 Electromagnetic compatibility... 3.4 Protective grounding ... 3.5 Equipotential grounding... 3.6 Laser radiation... 3.7 Temperature... 3.8 Printers ... 3.9 System failure... 3.10 Mechanics ... 3.11 Lower vertical position...
3-1 3-1 3-2 3-4 3-4 3-4 3-5 3-6 3-7 3-8 3-8 3-9
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Mechanical Handling 4.1 Transport position... 4.1.1 Mobile stand transport position ... 4.1.2 Monitor cart transport position... 4.2 Braking and steering the monitor cart ... 4.3 Braking and steering the mobile 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 ...
4-1 4-1 4-1 4-4 4-5 4-6 4-8 4-8 4-10 4-12 4-14 4-16
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Contents
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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 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 ... 5.3.1 General ... 5.3.2 Hand switch... 5.3.3 Two-pedal foot switch... 5.3.4 Four-pedal foot switch ... 5.3.5 Dual Plus foot switch ...
5-1 5-1 5-1 5-3 5-8 5-9 5-11 5-12 5-13 5-14 5-14 5-14 5-15 5-15 5-18
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Switching the System On and Off 6.1 Preparing the system... 6.2 Switching the system on and off... 6.3 EMERGENCY STOP push button... 6.4 Key switch ...
6-1 6-1 6-2 6-3 6-4
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Standard Fluoroscopic Operations 7.1 Overview... 7.2 Fluoroscopy modes ... 7.2.1 Pulsed fluoroscopy ... 7.2.2 Digital radiography (snapshot) ... 7.2.3 Dose reduction ... 7.3 Manual exposure rate setting ... 7.4 Object-Detected Dose Control (ODDC) in the Extremities/cervical spine/head and Trunk anatomical programs ... 7.5 Fluoroscopy programs... 7.5.1 Anatomical programs ... 7.5.2 Metal Artifact Correction function ... 7.5.3 Motion function ... 7.5.4 High Quality function ... 7.5.5 Children function (n/a for USA) ... 7.5.6 Low Dose function (USA only) ... 7.5.7 Automatic Dose Reduction function ... 7.5.8 Automatic Noise Filter Adjustment function... 7.5.9 High-level Control function (USA only) (Vision R only) ... 7.6 Screen display during radiation ... 7.7 Dose area product ... 7.8 Air kerma ... 7.9 Save ... 7.10 Print Live Screen image ... 7.11 Warning signals and malfunctions... 7.11.1 Permanent warning during radiation ... 7.11.2 Interval warning during radiation ... 7.11.3 Temperature monitoring ... 7.11.4 Error and alert messages ...
7-1 7-1 7-2 7-2 7-4 7-5 7-6
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7-8 7-8 7-8 7-10 7-11 7-11 7-12 7-12 7-13 7-13 7-13 7-14 7-14 7-15 7-15 7-17 7-19 7-19 7-19 7-20 7-20
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Adjusting Live Images 8.1 Overview ... 8.2 Filter ... 8.2.1 Recursive filter ... 8.2.2 Edge filter ... 8.2.3 LIH filter... 8.3 Contrast and brightness adjustment of images in the SmartEye (windowing) . 8.4 Electronic image magnification... 8.5 Collimation... 8.5.1 Iris Collimator ... 8.5.2 Slot collimator ... 8.6 Image Swapping... 8.6.1 Endoscopy ... 8.7 Image reversal and image rotation... 8.7.1 Horizontal and vertical image reversal ... 8.7.2 Image Rotation... 8.8 Grayscale Inversion...
8-1 8-1 8-2 8-2 8-3 8-4 8-6 8-8 8-9 8-9 8-9 8-11 8-11 8-12 8-12 8-12 8-13
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Data Management 9.1 Organization of patient and image data ... 9.1.1 Patient folders ... 9.1.2 System-generated patient folders ... 9.2 Managing patient data... 9.2.1 Managing patient data securely (HIPAA) ... 9.2.2 Creating a new patient folder ... 9.2.2.1 Entering patient data manually ... 9.2.3 Editing patient data ... 9.3 Image data management ... 9.3.1 Managing patient folders... 9.3.1.1 Marking patient folders ... 9.3.1.2 Deleting patient folders ... 9.3.1.3 Inverting the entire archive ... 9.3.1.4 Saving patient folders ... 9.3.2 Finding and displaying a patient folder... 9.3.3 Activating a patient folder... 9.3.4 Browsing through the active patient folder ... 9.3.5 Processing and outputting images of a patient folder ... 9.3.5.1 Displaying an image at full size ... 9.3.5.2 Marking images ... 9.3.5.3 Protecting images ... 9.3.5.4 Deleting images ... 9.3.5.5 Printing on video printer... 9.3.5.6 Saving images ... 9.3.5.7 Dose protocol details ... 9.3.6 Comparing saved images ... 9.3.7 Delete selection ... 9.3.8 Making backup copies of patient folders ... 9.3.8.1 Backup to USB storage medium... 9.3.8.2 Backup copy to CD/DVD ...
9-1 9-1 9-1 9-2 9-2 9-4 9-9 9-9 9-10 9-12 9-13 9-14 9-15 9-15 9-16 9-18 9-19 9-22 9-23 9-25 9-26 9-26 9-27 9-28 9-29 9-31 9-32 9-33 9-34 9-35 9-37
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DICOM Functions 10-1 10.1 Prerequisites ... 10-1 10.2 Retrieving patient data from a DICOM server ... 10-1
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Contents
10.2.1 10.2.2
10.3 10.4 10.5 10.6 10.7 10.8
Query ... 10-2 Retrieving a Worklist ... 10-3 10.2.2.1 Downloading a Worklist for a specific time span... 10-3 10.2.2.2 Downloading a patient-specific Worklist ... 10-5 10.2.2.3 Downloading a Worklist for a procedure step ... 10-7 Processing scheduled procedure steps of a Worklist (MPPS) ... 10-8 Saving all images from one or several patient folders... 10-10 Saving and printing images and cine loops from a patient folder ... 10-12 Saving or printing single cine loop images ... 10-14 Importing images and cine loops from a DICOM server... 10-15 Storage Commitment... 10-18
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Cine Loops 11-1 11.1 Overview... 11-1 11.2 Generating a cine loop ... 11-2 11.3 Opening a saved cine loop ... 11-4 11.4 Controlling and editing a cine loop during playback ... 11-6 11.5 Processing and outputting saved cine loops ... 11-9 11.5.1 Replaying a cine loop ... 11-10 11.5.2 Marking cine loops ... 11-10 11.5.3 Protecting cine loops ... 11-11 11.5.4 Deleting cine loops ... 11-11 11.5.5 Printing on video printer ... 11-12 11.5.6 Saving cine loops ... 11-13 11.6 Processing and outputting single cine loop images... 11-16 11.6.1 Marking cine loop images... 11-17 11.6.2 Protecting cine loop images ... 11-17 11.6.3 Deleting cine loop images ... 11-18 11.6.4 Printing cine loop images on the video printer ... 11-19 11.6.5 Saving cine loop images ... 11-21
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Vascular Operating Mode 12-1 12.1 Overview... 12-1 12.2 Acquiring a DSA cine loop... 12-3 12.3 Generate Multi Frame RSA ... 12-6 12.4 Generate Single Frame RSA... 12-7 12.5 Acquiring an MSA image ... 12-8 12.6 Acquiring an RSA image ... 12-8 12.7 Generating an MSA image or RSA image automatically... 12-9 12.8 Generating MSA and RSA images from a saved DSA cine loop ... 12-12 12.8.1 Opening and post-processing a DSA cine loop in an active patient folder ... 12-12 12.8.2 Opening and post-processing a DSA cine loop from any patient folder ... 12-13 12.9 Editing a DSA cine loop... 12-14 12.10 Pixel shift ... 12-16 12.11 Landmarking... 12-17
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Post-Processing Images 13.1 Overview... 13.2 Activating the post-processing functions ... 13.3 Contrast and brightness adjustment of individual images (windowing) ... 13.4 Edge filter ... 13.5 Digital zoom...
IV
13-1 13-1 13-3 13-4 13-6 13-7
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13.6 Grayscale inversion... 13-8 13.7 Image Rotation ... 13-8 13.8 Horizontal and vertical image reversal ... 13-9 13.9 Digital collimation (image crop) ... 13-9 13.10 Marking and deleting images ... 13-10 13.11 Outputting post-processed images... 13-12 14
Measurement 14-1 14.1 Measuring functions ... 14-1 14.2 Calibrating ... 14-3 14.3 Measuring a length or distance ... 14-5 14.4 3-point measurement ... 14-8 14.5 4-point measurement ... 14-11 14.6 4-point ratio measurement ... 14-14
15
Displayed Texts and Text Functions 15.1 Overview ... 15.2 Image information on the screen... 15.2.1 Upper left corner of the screen... 15.2.2 Upper right corner of the screen ... 15.2.3 Lower left corner of the screen... 15.2.4 Lower right corner of the screen ... 15.3 Entering and editing text...
16
Laser Positioning Device 16-1 16.1 Applications ... 16-2
17
Direct Radiography 17.1 Overview ... 17.2 Fitting the film cassette holder... 17.3 Making a direct radiographic exposure ...
18
System Configuration 18-1 18.1 Overview ... 18-1 18.2 Operation settings ... 18-2 18.2.1 Autotransfer ... 18-2 18.2.2 Autostore... 18-2 18.2.3 Image Swap with Save ... 18-3 18.2.4 Displaying a crosshair ... 18-4 18.2.5 Defining the start screen ... 18-6 18.2.6 Navigation ... 18-7 18.2.7 Discarding the operation settings... 18-8 18.3 Basic settings ... 18-8 18.3.1 Setting the system date and the system time ... 18-8 18.3.2 Selecting the live screen ... 18-9 18.3.3 Entering the hospital data ... 18-10 18.3.4 Discarding the basic settings ... 18-10 18.4 Cine/DSA/Dose ... 18-11 18.4.1 Cine loop settings ... 18-11 18.4.2 Showing or hiding the native image ... 18-13 18.4.3 MSA Autotransfer... 18-13 18.4.4 DSA CO2 ... 18-14 18.4.5 RSA direct ... 18-16 18.4.6 Discarding the cine loop and subtraction mode settings... 18-17
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17-1 17-1 17-1 17-2
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Contents
18.5 Storage media ... 18-17 18.5.1 Defining the USB stick storage format ... 18-18 18.5.2 Defining the CD/DVD storage format ... 18-18 18.5.3 Deleting data from storage media ... 18-19 18.5.4 DICOM storage server ... 18-20 18.5.5 Quick Cine Export ... 18-21 18.6 Injector... 18-22 18.7 Setting the flat-screen monitors... 18-23 18.7.1 Flat-screen monitors of type 1... 18-24 18.7.2 Flat-screen monitors of type 2... 18-29 18.7.3 19" DUO flat-screen ... 18-33 18.7.4 26“ flat-screen ... 18-40 18.7.4.1 Basic settings in the configuration menu ... 18-41 18.7.4.2 Advanced settings in the configuration menu ... 18-45 18.7.4.3 Quick select functions ... 18-47
VI
Appendix A A.1 Regular checks... A.2 Medical devices log book ... A.3 Cleaning, disinfection, sterilization ... A.3.1 Cleaning ... A.3.2 Disinfection... A.3.3 Sterilization... A.4 Malfunctions ... A.4.1 Types of malfunctions ... A.4.1.1 Alerts during power-up... A.4.1.2 Errors during power-up ... A.4.1.3 Alerts during operation... A.4.1.4 Errors during operation ... A.4.2 List of errors, alerts and status messages... A.4.3 Circuit breaker ... A.5 Type labels ... A.6 Labels (USA/Canada)... A.7 Radiation window opening... A.7.1 Ziehm Vision ... A.7.2 Ziehm Vision FD... A.7.3 Ziehm Vision R ... A.8 Heat capacity... A.9 Scattered radiation in the significant zone of occupancy... A.9.1 Ziehm Vision ... A.9.2 Ziehm Vision FD... A.9.3 Ziehm Vision R ... A.10 Dimensions... A.11 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 ... A.11.3 Laser Positioning Device... A.11.4 Dose meter chamber...
A-1 A-1 A-2 A-3 A-3 A-3 A-4 A-5 A-5 A-5 A-5 A-6 A-6 A-7 A-17 A-18 A-21 A-33 A-33 A-34 A-35 A-36 A-38 A-38 A-39 A-40 A-41 A-46 A-50 A-55 A-60 A-60
Appendix B B.1 Attaching sterile disposable covers to the C-arm ...
B-1 B-1
Appendix C C.1 Approved third-party components ...
C-1 C-1
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Contents
Glossary
1
Index
i
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Contents
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General Information
This document is designed to enable owners and operators to operate the system described herein safely and efficiently. This document applies to the following system versions, respectively software version 5.30.3 or higher.
Scope of validity of this document
Systems with image intensifier only: Ziehm Vision Ziehm Vision² Ziehm Vision R Systems with flat-panel detector only: Ziehm Vision FD Ziehm Vision² FD NOTE Descriptions covered by this document in general apply to all system versions. Varying descriptions are specifically indicated by system model. All illustrations are examples only, and may differ from the actual situation. This document describes a system with maximum configuration. Due to customer-specific system configuration or country-dependent approval restrictions the system may not contain all options and functions described here In this case, concerned descriptions do not apply to the system. Consequently, please ignore those contents. 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.
Separate operating instructions
The system does not produce any waste during operation.
Environmental compatibility
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.
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1 General Information
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
1.1
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.
Typographical conventions In this document, the following notations and formats are used to highlight certain elements of the Vision Center control panel or the documentation itself: Element
Format
Example
Vision Center elements (buttons, symbols and boxes), operating modes, functions
Bold
Fluoro
Cross-references
Italic, preceded by an arrow
→ Ch. 18, p. 18-1
Procedure steps
Preceded by a
Press the OK button.
Text input
Courier, bold
Administrator
Table 1-1
1-2
Notations and formats used in this document
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1 General Information
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.
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.
1.3
Conventions for norm naming NOTE This document uses the term IEC 60601 to identify all relevant national norms based on IEC 60601.
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1 General Information
1.4
Conventions for labeling of figures This document contains figures labeled by numbers. The numbers are explained in the adjacent text or by means of a caption visualized as a table. The numbers are indicated as (X). If a caption refers to multiple figures you find a special note.
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System Overview
2.1
Fields of application
The Ziehm Vision and Ziehm Vision² are mobile C-arm X-ray image intensifiers which are suitable for all surgical applications in traumatology, orthopedics, neurosurgery, urology and cardiology, for use in gastroenterology and endoscopy as well as for all vascular applications.
Ziehm Vision Ziehm Vision²
The fully-digital Ziehm Vision FD and Ziehm Vision² FD are suitable for more demanding vascular interventions requiring a high level of precision. As the system is distortion-free, it is especially suitable for afterloading treatment planning and navigation.
Ziehm Vision FD Ziehm Vision² FD
The Ziehm Vision R has a rotating anode and is therefore especially suitable for applications where high power output is required. This may be the case e.g. in vascular surgery for AAA procedures (Abdominal Aortic Aneurysms), especially performed on adipose patients in order to penetrate the object. This feature is also essential in cardiologic procedures, where small vessels of fast-moving objects need to be visualized. To reduce motion blur, the exposure time intervals are minimized while the dose rate is increased.
Ziehm Vision R
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. With its color screen the monitor cart (endoscopy) is specifically equipped for visualizing endoscopic applications.
Endoscopy
In order to user the monitors as image display devices of a certain application category, you must inspect them according to the legal regulations of DIN V 6868-57 or other applicable national regulations,
Application categories of image display devices
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2 System Overview
2.2
Features
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 efficient exposure rate and image quality control as well as high operating comfort. A ‘Soft’ program for soft tissue visualization during foreign body and implants 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 pulsed digital high-frequency generator along with a reduced pulse rate enable a significant reduction in the patient skin dose. Radiation-free collimation is provided by the system’s ‘Virtual Collimator’.
Image quality
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
Running in pulsed fluoroscopy mode, the Ziehm Vision allows a significant dose reduction.
Ziehm Vision FD
The Ziehm Vision FD features a fully-digital image processing chain. The digital flat-panel detector ensures distortion-free images.
Ziehm Vision R
The Ziehm Vision R provides short pulses of high intensity.
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 excellent 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.
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2 System Overview
A patient-based image management system providing a 16-image mosaic view, SmartArchive function 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 JPEG format with reduced resolution and reduced color depth DICOM format DICOM format with reduced resolution and reduced color depth Multimedia format: AVI (CD or 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 (separate document). The optional Ziehm NaviPort interface is an interface, enabling the integration of 2D navigation systems from different manufacturers.
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Ziehm NaviPort
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2.3
Options This document describes 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 upon request: Vascular Plus Package (DSA, MSA, RSA, Pixel Shift, Landmarking including cine loops with 12.5 frames/s, Dual Plus foot switch, DVI interface) Vascular Advance Package (includes the Vascular Plus Package option including cine loops with 25 frames/s, measuring functions) 31 cm image intensifier Vertical movement expansion of the C-arm by 20 cm (n/a for 31cm image intensifier, n/a for USA) Integrated dose meter for measuring the dose area product Laser positioning device on the generator and/or image intensifier Ziehm Vision FD: Laser positioning device on the generator NaviPort (only in combination with DICOM 3.0 interface) Key switch Power on/off or X-ray on/off EMERGENCY STOP push button on monitor cart 20 kW generator (Ziehm Vision R) Four-pedal foot switch Dual Plus foot switch Customer-specific foot switch assignment Floating interface for external separate radiation indication lamp or injector DVD writer Video printer Sony® UP-970 (for printout on paper) or UP-990 (for printout on paper or transparent film) external 60 Hz video connection External flat-screen 2 additional video connections for external flat-screen monitors (right and left monitor), optionally with analog (BNC socket) or digital signal (DVI socket) Color-coded handles (blue: orbital rotation brake, yellow: horizontal movement brake, red: swivel arm brake) Subtraction modes: DSA, MSA, RSA Pixel shift and landmarking DSA function for visualization with CO2 as contrast medium
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