ziehm_vision_series_operating_instrutcions_oct_2011.pdf
Page 1
Ziehm Vision Vario
Ziehm Vision Vario 3D
Ziehm Vision FD Vario
Ziehm Vision FD Vario 3D
Ziehm Vision² Vario
Ziehm Vision² Vario 3D
Ziehm Vision² FD Vario
Ziehm Vision² FD Vario 3D
Operating Instructions
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 2
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: info@ziehm-eu.com
http://www.ziehm.com
Rev. 10/2011
2
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 3
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
3
Page 4
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.
4
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 5
Contents
Contents
I
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 ................................................................................
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
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
I
Page 6
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
II
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
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 7
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
10
NaviPort (n/a for USA)
10-1
11
Adjusting Live Images
11.1 Overview ..........................................................................................................
11.2 Filters................................................................................................................
11.2.1 Recursive filter ..................................................................................
11.2.2 Edge filter ..........................................................................................
11.2.3 LIH filter.............................................................................................
11.3 Contrast and brightness adjustment of images in the Ziehm
SmartEye (windowing) .....................................................................................
11.4 Electronic image magnification.........................................................................
11.5 Collimation........................................................................................................
11.5.1 Iris collimator .....................................................................................
11.5.2 Slot collimator ...................................................................................
11.6 Image Swapping...............................................................................................
11.7 Image reversal and image rotation...................................................................
11.7.1 Horizontal and vertical image reversal ..............................................
11.7.2 Image rotation ...................................................................................
11.8 Grayscale Inversion..........................................................................................
11-1
11-1
11-2
11-2
11-4
11-5
11-6
11-8
11-9
11-9
11-9
11-11
11-11
11-12
11-12
11-13
Data Management in Non-Isocentric Operating Mode
12.1 Organization of patient and image data ...........................................................
12.1.1 Patient folders ...................................................................................
12.1.2 System-generated patient folders .....................................................
12.2 Managing patient data......................................................................................
12.2.1 Managing patient data securely (HIPAA) ..........................................
12.2.2 Creating a new patient folder ............................................................
12.2.2.1 Entering patient data manually ..........................................
12.2.3 Editing patient data ...........................................................................
12.3 Managing image data.......................................................................................
12.3.1 Managing patient folders...................................................................
12.3.1.1 Marking patient folders ......................................................
12.3.1.2 Deleting patient folders ......................................................
12.3.1.3 Inverting the entire archive ................................................
12.3.1.4 Saving patient folders ........................................................
12.3.2 Finding and displaying a patient folder..............................................
12.3.3 Activating a patient folder..................................................................
12.3.4 Browsing through the active patient folder ........................................
12.3.5 Processing and outputting images in a patient folder .......................
12.3.5.1 Displaying an image at full size .........................................
12.3.5.2 Marking images .................................................................
12.3.5.3 Protecting images ..............................................................
12.3.5.4 To delete images ...............................................................
12.3.5.5 Printing on video printer.....................................................
12-1
12-1
12-1
12-2
12-2
12-4
12-9
12-9
12-10
12-12
12-13
12-14
12-15
12-16
12-16
12-18
12-20
12-22
12-23
12-25
12-25
12-26
12-27
12-28
12
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
III
Page 8
Contents
12.3.5.6 Saving images ...................................................................
12.3.5.7 Dose protocol details .........................................................
Comparing saved images..................................................................
Delete selection.................................................................................
Making backup copies of patient folders ...........................................
12.3.8.1 Backup to USB storage medium........................................
12.3.8.2 To CD/DVD .......................................................................
12-29
12-31
12-31
12-32
12-34
12-35
12-37
13
Data management in isocentric operating mode
13.1 Settings.............................................................................................................
13.2 Searching for patient folders.............................................................................
13.3 Activating a patient folder .................................................................................
13.3.1 Iso Cine .............................................................................................
13.3.2 3D reconstruction (Ziehm Vision Vario 3D only) ...............................
13.3.3 Screenshot (Ziehm Vision Vario 3D only) .........................................
13.4 Delete data .......................................................................................................
13.5 Import patient folders from a CD/DVD..............................................................
13.6 Write data to CD/DVD ......................................................................................
13.7 Importing patient folders from a USB stick .......................................................
13.8 Saving data to a USB stick ...............................................................................
13.9 Transferring data to the DICOM server with DICOM Storage ..........................
13.10 Printing data .....................................................................................................
13-1
13-3
13-7
13-8
13-9
13-12
13-14
13-15
13-16
13-18
13-19
13-20
13-21
13-22
14
DICOM Functions
14.1 Prerequisites.....................................................................................................
14.2 Downloading patient data from a DICOM server..............................................
14.2.1 Query ................................................................................................
14.2.2 Downloading a Worklist.....................................................................
14.2.2.1 Downloading a Worklist for a specific time span................
14.2.2.2 Downloading a patient-specific Worklist ............................
14.2.2.3 Downloading a Worklist for a procedure step ....................
14.3 Processing scheduled procedure steps of a Worklist (MPPS) .........................
14.4 Saving all images from one or several patient folders......................................
14.5 Saving and printing images and cine loops from a patient folder .....................
14.6 Saving or printing single cine loop images .......................................................
14.7 Importing images and cine loops from a DICOM server...................................
14.8 Storage Commitment........................................................................................
14.9 Isocentric operating mode ................................................................................
14.9.1 DICOM settings .................................................................................
14.9.2 Transferring data to the DICOM server with DICOM Storage ...........
14-1
14-1
14-1
14-1
14-2
14-3
14-5
14-6
14-7
14-10
14-11
14-13
14-14
14-18
14-19
14-19
14-21
15
Cine Loops
15.1 Overview...........................................................................................................
15.2 Generating a cine loop .....................................................................................
15.3 Opening a saved cine loop ...............................................................................
15.4 Controlling and editing a cine loop during playback .........................................
15.5 Processing and outputting saved cine loops ....................................................
15.5.1 Replaying a cine loop ........................................................................
15.5.2 Marking cine loops ............................................................................
15.5.3 Protecting cine loops .........................................................................
15.5.4 Deleting cine loops ............................................................................
15.5.5 Printing on video printer ....................................................................
15.5.6 Saving cine loops ..............................................................................
15-1
15-1
15-1
15-3
15-6
15-8
15-9
15-10
15-10
15-11
15-12
15-13
12.3.6
12.3.7
12.3.8
IV
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 9
Contents
15.6 Processing and outputting single cine loop images .........................................
15.6.1 Marking cine loop images .................................................................
15.6.2 Protecting cine loop images ..............................................................
15.6.3 Deleting cine loop images .................................................................
15.6.4 Printing cine loop images on the video printer ..................................
15.6.5 Saving cine loop images ...................................................................
15-15
15-16
15-17
15-17
15-18
15-20
Vascular Operating Mode
16.1 Overview ..........................................................................................................
16.2 Motor-driven C-arm positioning ........................................................................
16.3 Isocentric examinations in Fluoroscopy operating mode .................................
16.4 Acquiring a DSA cine loop................................................................................
16.5 Generate Multi Frame RSA ..............................................................................
16.6 Generate Single Frame RSA............................................................................
16.7 Acquiring an MSA image..................................................................................
16.8 Acquiring an RSA image ..................................................................................
16.9 Generating an MSA image or RSA image automatically..................................
16.10 Generating MSA and RSA images from a saved DSA cine loop .....................
16.10.1 Opening and postprocessing a DSA cine loop in an active
patient folder .....................................................................................
16.10.2 Opening and postprocessing a DSA cine loop from any patient
folder .................................................................................................
16.11 Editing a DSA cine loop....................................................................................
16.12 Pixel shift ..........................................................................................................
16.13 Landmarking.....................................................................................................
16-1
16-1
16-3
16-3
16-9
16-11
16-12
16-13
16-13
16-14
16-16
17
Post-Processing Images
17.1 Overview ..........................................................................................................
17.2 Activating the post-processing functions ..........................................................
17.3 Contrast and brightness adjustment of individual images (windowing)............
17.4 Edge filter .........................................................................................................
17.5 Digital zoom......................................................................................................
17.6 Grayscale inversion..........................................................................................
17.7 Image rotation ..................................................................................................
17.8 Horizontal and vertical image reversal .............................................................
17.9 Digital collimation (image crop) ........................................................................
17.10 Marking and deleting images ...........................................................................
17.11 Outputting post-processed images...................................................................
17-1
17-1
17-3
17-4
17-6
17-7
17-8
17-8
17-9
17-9
17-10
17-12
18
Measurement
18.1 Measuring functions .........................................................................................
18.2 Calibrating ........................................................................................................
18.3 Measuring a length or distance ........................................................................
18.4 3-point measurement .......................................................................................
18.5 4-point measurement .......................................................................................
18.6 4-point ratio measurement ...............................................................................
18-1
18-1
18-3
18-5
18-8
18-11
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..........................................................
19-1
19-1
19-1
19-1
19-1
19-2
16
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
16-16
16-17
16-19
16-20
16-21
V
Page 10
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.............................................................
20-1
20-1
20-1
20-2
21
System Configuration
21.1 Overview...........................................................................................................
21.2 User settings.....................................................................................................
21.2.1 Autotransfer.......................................................................................
21.2.2 Autostore ...........................................................................................
21.2.3 Image Swap with Save......................................................................
21.2.4 Displaying a crosshair .......................................................................
21.2.5 Defining the start screen ...................................................................
21.2.6 Navigation .........................................................................................
21.2.7 Discarding the operation settings ......................................................
21.3 Basic settings ...................................................................................................
21.3.1 Setting the system date and the system time....................................
21.3.2 Selecting the live screen ...................................................................
21.3.3 Entering the hospital data .................................................................
21.3.4 Discarding the basic settings.............................................................
21.4 Cine/DSA/Dose ................................................................................................
21.4.1 Cine loop settings..............................................................................
21.4.2 Showing or hiding the native image ..................................................
21.4.3 MSA Autotransfer ..............................................................................
21.4.4 DSA CO2 ...........................................................................................
21.4.5 RSA direct .........................................................................................
21.4.6 Discarding the cine loop and subtraction mode settings ...................
21.5 Storage media ..................................................................................................
21.5.1 Defining the USB storage medium format.........................................
21.5.2 Defining the CD/DVD storage format ................................................
21.5.3 Deleting data from storage media .....................................................
21.5.4 DICOM storage server ......................................................................
21.5.5 Quick Cine Export .............................................................................
21.6 Setting the flat-screen monitors........................................................................
21.6.1 Flat-screen monitors of type 1...........................................................
21.6.2 Flat-screen monitors of type 2...........................................................
21-1
21-1
21-3
21-3
21-3
21-4
21-5
21-7
21-8
21-8
21-9
21-9
21-10
21-10
21-11
21-12
21-12
21-13
21-14
21-15
21-15
21-16
21-17
21-17
21-18
21-19
21-19
21-20
21-22
21-23
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).........
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
VI
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 11
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
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
A-8
A-8
A-8
A-9
A-10
A-10
A-10
A-10
A-10
A-11
A-12
A-12
i
VII
Page 12
Contents
VIII
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 13
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
Page 14
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
Page 15
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.
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
1-3
Page 16
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
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 17
2
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
Page 18
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
Page 19
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
2-3
Page 20
2 System Overview
2.3
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
2-4
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 21
2 System Overview
1/2/4/8/12.5/25 fps for systems with image intensifier (at 50 Hz)
1/2/5/10/15/30 fps for systems with image intensifier (at 60 Hz)
Additional image storage capacity: 65,000 images
DICOM 3.0 interface Ziehm NetPort
Depending on the chosen system configuration, the following DICOM
classes are supported:
Print Class
Storage Class including multiframe capability
Storage Commitment Class
Media Class
Worklist Class
MPPS Class
Query/Retrieve Class
Verification Class
Ziehm DICOM Viewer
Consistency test kit
2.4
Optional accessories
The following accessories are optionally available:
Sterile disposable covers
Hand surgery table (n/a for Ziehm Vision FD Vario)
Universal film cassette holder (n/a for Ziehm Vision FD Vario)
Remote Vision Center (accessorial control panel)
(see corresponding operating instructions)
The following accessories are optionally available with NaviPort
interface:
Sterile disposable cover for 30 cm image intensifier (to be used for 23
cm image intensifier and flat-panel detector)
Sterile marker balls (disposables)
2.5
Optional accessories (USA)
Hand surgery table (n/a for Ziehm Vision FD Vario)
Universal film cassette holder (n/a for Ziehm Vision FD Vario)
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
2-5
Page 22
2 System Overview
2.6
X-ray protective equipment
We recommend that you use the following X-ray protective equipment:
X-ray protective apron
X-ray protective eyewear
Thyroid collar
X-ray protective gloves
2.7
Parts of the system
2.7.1
C-arm stand
Ziehm Vision Vario
Image intensifier with integrated CCD camera
C-arm
Vision Center
control panel
Horizontal carriage
Black locking
pins
Lifting column
Cassette holder
Swivel arm
Emergency
Stop button
C-arm handles
Steering &
braking lever
Generator
Handle
Hand
switch
Vario cable connection (labeled
Vario)
Coupling
cable connection
Foot switch connection
Cable
guards
Fig. 2-1
2-6
C-arm stand Ziehm Vision Vario
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 23
2 System Overview
Digital flat-panel detector
C-arm
Ziehm Vision FD
Vario
Vision Center
control panel
Horizontal carriage
Black locking
pins
Lifting
column
Emergency
Stop button
Swivel arm
Steering &
braking lever
C-arm
handles
Generator
Handle
Hand
switch
Vario cable connection (labeled
Vario)
Foot switch connection
Coupling
cable connection
Cable
guards
Fig. 2-2
Ziehm Vision FD Vario C-arm stand
2.7.2
Monitor cart
Radiation indication lamp
EMERGENCY
STOP button
Monitor cart, front
view
Flat-screen
monitors
X-Ray key switch
Control panel
USB port
Video printer
DVD writer
Foot lever for
braking and
direction
locking
Fig. 2-3
Monitor cart, front view
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
2-7
Page 24
2 System Overview
Monitor cart, rear
view
USB mouse port
Coupling
cable and
Vario cable
support
Interface panel for
monitor outputs,
service keyboard
and DICOM
( Fig. 2-5)
Power cable
support
Coupling cable
connection
Circuit breaker
Vario cable
connection
VIDEO OUT
(option)
Remote
Vision Center
(optional)
Equipotential
grounding
2. Equipotential
grounding
Fig. 2-4
Interface panel on
monitor cart
Power supply
connection
Monitor cart, rear view
DICOM/NaviPort R-TNC USB port
connection (RJ-45) antenna
Connection for external
radiation indication lamp
2%
VIDEO OUT
Fig. 2-5
2-8
VIDEO OUT 2
RM
VIDEO OUT 1
LM
Interface panel on the monitor cart, example of detailed
view
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
Page 25
2 System Overview
NOTE
When preparing the monitor cart for transportation
( Ch. 4.1.2, p. 4-4) first wind the power cable onto the
lower cable support and then the coupling cable and the
Vario cable (labeled Vario) onto the upper cable support.
Your monitor cart is equipped with a plug connection for equipotential
grounding, e.g. with a hospital bed.
Equipotential
grounding
In addition, a screw connection for equipotential grounding (spare equipotential grounding connection) is available.
If your system is equipped with Wireless LAN, a receiver is integrated into
the monitor cart. You can see the R-TNC antennas at the back of the
monitor cart. The other receiver is supplied with your accessories and
must be connected to the DICOM network.
2.7.3
Integrated Wireless
LAN on the monitor
cart
Screen assignment
The live screen function has been factory-assigned to the left screen, and
the reference screen function to the right screen.
Live and reference
screen
During operation, the following images will be displayed on the screens:
Live screen: Live images and saved images, both at full size
While the radiation indication lamp is illuminated, you always see a
live image.
When you terminate radiation, a composite image made up of 1 to 16
individual images (LIH – Last Image Hold) is displayed on the live
screen. The amount of images that are used for computing the LIH
depends on the selected anatomical program. The default values are
preset in the anatomical programs. You can modify these settings
using the LIH filter controls.
Last Image Hold
The kV and mA values that are displayed on the user interface are the
values set by the system upon termination of radiation emission. The
number that appears under LIH on the screen indicates how many
individual images have been used for computing the LIH ( p. 19-2).
Reference screen: Thumbnail mosaic, reference images at full size
NOTE
To avoid confusion, the neutral terms ‘live screen’ and
‘reference screen’ are used throughout this document,
regardless of your custom setting.
Ziehm Vision Vario
P_28250/CD_28251_EN-14/10/2011
2-9