Ziehm 7000 Plus C-Arm User Manual
Ziehm 7000 Plus
Ziehm 7000 Plus
(Compact Version)
User Manual
Ziehm 7000 Plus
28140-4_22.02_EN_00
Safety instructions This manual 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.
Intended use 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.
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 limiting values indicated in this user manual must not be exceeded; this applies also
when putting the system into service.
Authorized personnel Only authorized personnel are allowed to assemble and repair the medical equipment
described in this manual. Authorized personnel are persons who have attended an
appropriate training course provided by the manufacturer.
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;
• the system is used in accordance with the user manual.
Repair work carried out by non-authorized personnel will lead to an invalidation of the
warranty. Furthermore, no consequential damages will be accepted.
The equipment conforms to Class IIb according to the Council Directive 93/42/EEC.
This user manual has been written and reviewed originally in German and translated.
Copyright
Copyright © 2006 Ziehm Imaging GmbH •
Donaustr. 31 • D-90451 Nuremberg • Germany •
E-mail: info@ziehm-eu.com •
Internet: http://www.ziehm.com
All rights reserved.
Transmission or reproduction of this manual, 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 manual 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 manual was produced in compliance with the quality principles
of ISO 9001. The information provided in this manual is checked at
regular intervals, and any corrections which might become
necessary will be included in the next revision. Any suggestions for
improvement are welcome.
Subject to change without prior notice.
Rev. 02/2006
Ziehm 7000 Plus
28140-4_22.02_EN_00
Table of Contents
Table of Contents I
1 About this Manual 1-1
2 System Overview 2-1
2.1 Fields of application and features..................................................................... 2-1
2.1.1 Fields of application .......................................................................... 2-1
2.1.2 Features............................................................................................ 2-1
2.2 Model range ..................................................................................................... 2-3
2.2.1 Ziehm 7000 Plus ............................................................................... 2-3
2.2.2 Ziehm 7000 Plus (Compact Version) ................................................ 2-3
2.3 Options ............................................................................................................. 2-4
2.4 Optional accessories ........................................................................................ 2-5
2.5 Parts of the system........................................................................................... 2-6
2.5.1 Mobile C-arm stand........................................................................... 2-6
2.5.2 Monitor cart ....................................................................................... 2-7
2.5.3 Ziehm 7000 Plus (Compact Version) ................................................ 2-8
2.5.4 Monitors ............................................................................................ 2-9
2.5.5 Video output...................................................................................... 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 Environmental compatibility.............................................................................. 3-6
4 Putting the System into Service 4-1
4.1 Unpacking the system ...................................................................................... 4-1
4.2 Accessories ...................................................................................................... 4-2
4.3 Cable connections............................................................................................ 4-3
4.4 First power-up of the system ............................................................................ 4-4
4.5 Setting up the system....................................................................................... 4-5
5 Mechanical Handling 5-1
5.1 Transport position............................................................................................. 5-1
5.1.1 C-arm stand transport position.......................................................... 5-1
5.1.2 Monitor cart transport position........................................................... 5-2
5.2 Braking and steering the monitor cart .............................................................. 5-3
5.3 Braking and steering the C-arm stand.............................................................. 5-3
5.4 C-arm movements............................................................................................ 5-5
5.4.1 Orbital rotation .................................................................................. 5-5
5.4.2 Angulation ......................................................................................... 5-6
5.4.3 Swiveling (panning)........................................................................... 5-7
5.4.4 Horizontal movement ........................................................................ 5-8
5.4.5 Vertical movement ............................................................................ 5-8
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6Controls 6-1
6.1 C-arm stand control panel ................................................................................ 6-1
6.2 Monitor cart control panel ................................................................................. 6-6
6.3 How to use menus............................................................................................ 6-9
7 Switching the System On and Off 7-1
7.1 Preparing the system........................................................................................ 7-1
7.2 Switching the system on................................................................................... 7-2
7.3 EMERGENCY STOP button............................................................................. 7-3
7.4 Key switch ........................................................................................................ 7-4
8 Standard Fluoroscopic Operations 8-1
8.1 Overview........................................................................................................... 8-1
8.2 Fluoroscopy modes .......................................................................................... 8-1
8.2.1 Continuous fluoroscopy..................................................................... 8-2
8.2.2 Continuous pulse fluoroscopy ........................................................... 8-3
8.2.3 Single pulse fluoroscopy (‘snapshot’)................................................ 8-3
8.3 Manual exposure rate setting ........................................................................... 8-4
8.4 Fluoroscopy programs...................................................................................... 8-5
8.4.1 ½ DOSE function key ........................................................................ 8-5
8.4.2 Anatomical programs ........................................................................ 8-5
8.4.3 METAL correction key ....................................................................... 8-6
8.5 Generating a fluoroscopic image...................................................................... 8-6
8.5.1 Starting fluoroscopy .......................................................................... 8-6
8.5.2 Screen display................................................................................... 8-7
8.6 Saving............................................................................................................... 8-8
8.7 Printing ............................................................................................................. 8-10
8.8 Warning signals and faults ............................................................................... 8-11
8.8.1 Permanent warning during radiation ................................................. 8-11
8.8.2 Interval warning during radiation ....................................................... 8-11
8.8.3 Temperature monitoring .................................................................... 8-12
8.8.4 Error and alert messages .................................................................. 8-13
9 Adjusting Live Images 9-1
9.1 Overview........................................................................................................... 9-1
9.2 Collimation........................................................................................................ 9-1
9.2.1 Iris collimator ..................................................................................... 9-1
9.2.2 Slot collimator.................................................................................... 9-2
9.2.3 Slot collimator rotation....................................................................... 9-2
9.2.4 Virtual collimator (n/a for Ziehm 7000 Plus (Compact Version)/Ziehm 7000
Plus (Compact Litho Version)) .......................................................... 9-2
9.3 Electronic image magnification......................................................................... 9-3
9.4 Contrast and brightness adjustment (Windowing)............................................ 9-4
9.4.1 Control from the C-arm stand............................................................ 9-4
9.4.1.1 Standard windowing........................................................... 9-5
9.4.1.2 Step windowing.................................................................. 9-5
9.4.2 Control from the monitor cart............................................................. 9-6
9.5 Image reversal and image rotation ................................................................... 9-8
9.5.1 Horizontal and vertical image reversal .............................................. 9-8
9.5.2 Image rotation ................................................................................... 9-8
9.6 Image swapping ............................................................................................... 9-9
9.6.1 Ziehm 7000 Plus ............................................................................... 9-9
9.6.2 Ziehm 7000 Plus (Compact Version), Ziehm 7000 Plus (Compact Litho
Version) ............................................................................................. 9-9
II Ziehm 7000 Plus
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Table of Contents
10 Data Management 10-1
10.1 Organization of patient and image data ........................................................... 10-1
10.1.1 Patient folders ................................................................................... 10-1
10.1.2 NO NAME folder ............................................................................... 10-2
10.2 Patient data management ................................................................................ 10-2
10.2.1 Creating a new patient folder on the Ziehm 7000 Plus ..................... 10-2
10.2.2 Modifying patient data ....................................................................... 10-4
10.3 Image data management ................................................................................. 10-6
10.3.1 Activating a patient folder.................................................................. 10-8
10.3.2 Backup to CD .................................................................................... 10-9
10.3.3 Finding patient folders....................................................................... 10-11
10.3.4 Deleting patient folders ..................................................................... 10-12
10.3.5 Inverting the grayscale of the entire image archive........................... 10-13
10.3.6 Processing and outputting images of a patient folder ....................... 10-14
10.3.6.1 Saving images ................................................................... 10-18
10.3.6.2 Printing images on video printer ........................................ 10-20
10.3.7 Comparing saved images ................................................................. 10-21
11 DICOM Functions 11-1
11.1 Prerequisites .................................................................................................... 11-1
11.2 Retrieving patient data from a DICOM server .................................................. 11-1
11.2.1 Query ................................................................................................ 11-1
11.2.2 Retrieving a Worklist ......................................................................... 11-2
11.3 Processing scheduled procedure steps of a Worklist (MPPS) ......................... 11-4
11.4 Importing images and cine loops from a DICOM server .................................. 11-6
11.5 Importing DICOM images from a storage medium (DICOM Dir)...................... 11-10
11.6 Saving and printing images.............................................................................. 11-15
11.6.1 Saving images .................................................................................. 11-15
11.6.2 Saving images to a second storage server ....................................... 11-16
11.6.3 Printing images ................................................................................. 11-19
11.7 Saving or printing single cine loop images....................................................... 11-21
11.7.1 Saving single cine loop images......................................................... 11-21
11.7.2 Saving single cine loop images to a second storage server ............. 11-23
11.7.3 Printing single cine loop images........................................................ 11-26
11.8 Storage Commitment ....................................................................................... 11-29
12 Cine Loops 12-1
12.1 Overview .......................................................................................................... 12-1
12.2 Acquiring a cine loop........................................................................................ 12-1
12.3 Opening and controlling a saved cine loop ...................................................... 12-5
12.4 Editing a saved cine loop ................................................................................. 12-7
12.5 Processing and outputting single cine loop images ......................................... 12-9
12.5.1 Saving single cine loop images......................................................... 12-13
12.5.2 Printing single cine loop images on video printer .............................. 12-16
13 Subtraction Modes 13-1
13.1 Overview .......................................................................................................... 13-1
13.2 DSA.................................................................................................................. 13-2
13.3 MSA.................................................................................................................. 13-3
13.4 RSA.................................................................................................................. 13-4
13.5 Auto-DSA ......................................................................................................... 13-5
13.6 Processing a saved DSA cine loop .................................................................. 13-6
13.7 Generating RSA images from a DSA cine loop................................................ 13-7
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IIIZiehm 7000 Plus
Table of Contents
13.8 Working with CO2 negative contrast medium .................................................. 13-8
13.9 Pixel shift .......................................................................................................... 13-10
13.10 Landmarking ..................................................................................................... 13-11
14 Post-Processing Images 14-1
14.1 Overview........................................................................................................... 14-1
14.2 Activating the post-processing functions .......................................................... 14-1
14.3 Edge enhancement .......................................................................................... 14-2
14.4 Image rotation................................................................................................... 14-3
14.5 Zooming............................................................................................................ 14-3
14.6 Grayscale inversion.......................................................................................... 14-4
14.7 Contrast and brightness adjustment (Windowing)............................................ 14-4
14.8 Measurements.................................................................................................. 14-6
14.8.1 Calibration ......................................................................................... 14-7
14.8.2 Length or distance measurement...................................................... 14-9
14.8.3 3-point measurement ........................................................................ 14-11
14.8.4 4-point measurement ........................................................................ 14-13
15 Displayed Texts and Text Functions 15-1
15.1 Overview........................................................................................................... 15-1
15.2 Automatically-displayed text information .......................................................... 15-1
15.2.1 Upper left corner of the live screen ................................................... 15-1
15.2.2 Upper right corner of the live screen ................................................. 15-2
15.2.3 Lower left corner of the live screen ................................................... 15-2
15.2.4 Lower right corner of the live screen ................................................. 15-3
15.3 Manual text annotation and editing................................................................... 15-3
16 Image Documentation 16-1
16.1 Overview........................................................................................................... 16-1
16.2 Printing on video printer.................................................................................... 16-1
16.3 Recording on video cassette recorder.............................................................. 16-2
17 Laser Positioning Device 17-1
17.1 Overview........................................................................................................... 17-1
17.2 Applications ...................................................................................................... 17-1
18 Direct Radiography 18-1
18.1 Overview........................................................................................................... 18-1
18.2 Fitting the film cassette holder.......................................................................... 18-1
18.3 Activating the direct radiography mode ............................................................ 18-2
18.4 Selecting the film size....................................................................................... 18-2
18.5 Selecting the radiography parameters.............................................................. 18-3
18.6 Making the radiographic exposure ................................................................... 18-3
18.7 Completing the radiographic procedure ........................................................... 18-4
18.8 Exposure guide................................................................................................. 18-4
IV Ziehm 7000 Plus
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Table of Contents
19 System Configuration 19-1
19.1 Overview .......................................................................................................... 19-1
19.2 User settings .................................................................................................... 19-2
19.2.1 Activating automatic image swapping ............................................... 19-2
19.2.2 Displaying a crosshair ....................................................................... 19-3
19.2.3 Function of the F key ........................................................................ 19-3
19.2.4 Storage medium for image retrieval .................................................. 19-4
19.2.5 Setting the cine loop speed............................................................... 19-4
19.2.6 Setting the cine loop length............................................................... 19-4
19.2.7 Combining DSA with a cine loop....................................................... 19-5
19.2.8 Showing or hiding the native image .................................................. 19-5
19.2.9 Selecting the storage medium for data retrieval with DICOM Dir...... 19-5
19.2.10 Defining the storage format for removable storage media................ 19-6
19.3 Basic settings ................................................................................................... 19-6
19.3.1 Setting the system time and system date ......................................... 19-7
19.3.2 Selecting the live screen ................................................................... 19-7
19.3.3 Entering the hospital data ................................................................. 19-7
19.3.4 Erasing storage media ...................................................................... 19-7
19.3.5 Re-initializing the barcode reader ..................................................... 19-7
19.4 Monitor settings................................................................................................ 19-8
19.4.1 Ziehm 7000 Plus with 23" flat-screen monitor................................... 19-8
19.4.2 Flat-screen monitor settings.............................................................. 19-9
19.4.2.1 Integrated button panel...................................................... 19-9
19.4.2.2 Setting the brightness, contrast and backlight brightness . 19-9
19.4.2.3 Setting the menu language................................................ 19-11
19.4.2.4 Restoring the factory settings ............................................ 19-12
19.5 Service settings................................................................................................ 19-13
19.5.1 Step windowing ................................................................................. 19-14
19.5.2 Filter factors ...................................................................................... 19-15
19.5.2.1 Filters for anatomical programs ......................................... 19-16
19.5.2.2 Filters for subtraction modes ............................................. 19-18
19.5.2.3 Filters for subtraction modes with CO2.............................. 19-19
19.5.3 Windowing settings for subtraction modes........................................ 19-20
19.5.4 DICOM settings................................................................................. 19-21
19.5.5 System settings................................................................................. 19-21
19.5.6 Monitor calibration............................................................................. 19-21
19.5.7 HEDIS data ....................................................................................... 19-21
19.5.8 Software update ................................................................................ 19-21
Appendix A-1
A.1 Regular checks................................................................................................. A-1
A.1.1 Routine checks to be performed by the user .................................... A-1
A.1.2 Consistency test according to national regulations ........................... A-2
A.1.3 Dose meter check ............................................................................. A-2
A.1.4 Checking the useful beam ................................................................ A-3
A.1.5 Leakage in the cooling system (only with Active Cooling) ................ A-4
A.1.6 Gettering the image intensifier tube .................................................. A-4
A.2 Cleaning, disinfection, sterilization ................................................................... A-5
A.2.1 Cleaning............................................................................................ A-5
A.2.2 Disinfection ....................................................................................... A-5
A.2.3 Sterilization ....................................................................................... A-6
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VZiehm 7000 Plus
Table of Contents
A.3 Faults................................................................................................................ A-6
A.3.1 Types of faults ................................................................................... A-6
A.3.1.1 Alerts during power-up ....................................................... A-6
A.3.1.2 Errors during power-up ...................................................... A-6
A.3.1.3 Alerts during operation ....................................................... A-7
A.3.1.4 Errors during operation ...................................................... A-7
A.3.2 List of error and alert messages........................................................ A-8
A.4 Labels on the unit ............................................................................................. A-11
A.4.1 Ziehm 7000 Plus labels..................................................................... A-11
A.4.2 Ziehm 7000 Plus (Compact Version) labels...................................... A-14
A.5 Focal spot position............................................................................................ A-21
A.6 Heat capacity.................................................................................................... A-22
A.7 Scattered radiation in the significant zone of occupancy.................................. A-23
A.8 AERC characteristics........................................................................................ A-24
A.9 Dimensions....................................................................................................... A-27
A.9.1 Ziehm 7000 Plus ............................................................................... A-27
A.9.2 Ziehm 7000 Plus (Compact Version) ................................................ A-29
A.1 Technical data Ziehm 7000 Plus and Ziehm 7000 Plus (Compact Version) .... A-31
A.9.3 Laser positioning device.................................................................... A-34
A.9.4 Dose measurement chamber............................................................ A-34
A.10 Connections for additional monitors and external radiation warning lamp ....... A-35
Index i
VI Ziehm 7000 Plus
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About this Manual 1
This manual is designed to enable owners and operators of a Ziehm
7000 Plus or Ziehm 7000 Plus (Compact Version) to operate the
respective system safely and efficiently.
Ziehm 7000 Plus and Ziehm 7000 Plus (Compact Version), software
version 22.02.
For several system options (e.g. video printer), separate operating
instructions are available. They are supplied with the system, provided
that the system configuration includes the respective option. You will find
a corresponding reference in the relevant sections of the manual.
Typographical conventions
In this manual, the following notations and formats are used to highlight
certain elements of the software interface, control panels or
documentation itself:
Element Format Example
Purpose of this
manual
Scope of validity of
this manual
Separate operating
instructions
Software interface
elements
Cascaded menus Bold, separated by an
Function keys Bold, current function
Names of keys Bold Enter
Cross-references Italic, preceded by an
Table 1-1 Notations and formats used in this manual
Bold Post windowing
Configuration Menu
arrow
separated by a dash
arrow
→ Basic Settings
F1 – Save
→ Ch. 19.3, p. 19-6
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1-1Ziehm 7000 Plus
1 About this Manual
Safety information The manual contains some information which must be observed in order
to ensure the personal safety of operating staff and patients as well as to
avoid damage to property. All such information is highlighted as follows:
WARNING
This is the highest level of risk. Personal injury or damage to property
may occur if the operator does not observe the instructions provided
here.
CAUTION
This means that a situation exists which may require a decision or action
on the part of the user for optimum equipment performance or to avoid
a minor hazard.
Note
Notes are merely informative. Additional useful information and hints are
provided for the operator here.
1-2 Ziehm 7000 Plus
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System Overview 2
2.1 Fields of application and features
2.1.1 Fields of application
ApplicationsThe Ziehm 7000 Plus is a mobile C-arm X-ray image intensifier which is
suitable for all surgical applications in traumatology, orthopedics,
neurology, urology, cardiology as well as for all vascular interventions.
Vascular surgeryThanks to its subtraction and cine loop functions, the Ziehm 7000 Plus
can be used for all vascular applications.
Casualty wardThe Ziehm 7000 Plus (Compact Version) lends itself to rapid casualty X-
ray diagnostics in the emergency ward.
LithotripsyThe Ziehm 7000 Plus (Compact Litho Version) is designed to support
lithotripter procedures. The lithotripter is mounted onto the Ziehm 7000
Plus (Compact Litho Version) for this purpose.
2.1.2 Features
Ziehm 7000 Plus offers unrestricted mobility at the operating table, even
if space is scarce.
The easy adjustability of the ample C-arm and the perfect counterbalancing of the C-arm stand make it possible to access even the most
difficult positions.
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 foreign body localization and
a ‘Metal’ program for suppressing image flare resulting from the use of
metal implants and surgical instruments complete the automatic
functions.
MobilityWith its compact design and combined steering & braking system, the
Anatomical
programs
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2-1Ziehm 7000 Plus
2 System Overview
Radiation dose
reduction
The superior penetration capabilities of the digital high-frequency
generator enable a significant reduction in the patient skin dose.
The ½ DOSE function considerably reduces the dose both for patient and
operating staff, thus contributing substantially to radiation protection.
Furthermore, radiation-free collimation is provided by the system’s
‘Virtual Collimator’.
Image quality 150 Hz monitor tubes with anti-reflection coating guarantee flicker-free
images. The new, advanced image processing technology generates
noise-free images without motion artifacts, even if the subject has
moved.
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 (postprocessing).
Active Cooling The Active Cooling option allows for nearly unlimited fluoroscopy times,
being often indispensable e.g. in cardiac and vascular surgery.
Image management A patient-based image management system providing a 16-image
mosaic view and menu-controlled user guidance guarantees efficient
image data handling.
Documentation and
output
For documentation purposes, a video printer and a video cassette
recorder are available. A CD writer as well as a floppy disk drive allow
filmless archiving in PC-compatible TIF format and optionally in DICOM
format. The system documents not only patient-related data, but also
image-related data (e.g. the fluoroscopy parameters).
In addition, all systems have a video output.
Networkability The optional DICOM 3.0 interface 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
available: Print, Storage (including multiframe capability), Storage
Commitment, Media, Worklist, MPPS, Query/Retrieve and Verification.
It is possible to connect the Ziehm 7000 Plus to a second DICOM storage
server (to act for example as standby server) and to configure the system
in such a way that data can be saved to that second DICOM storage
server, if necessary.
For more information on DICOM, please refer to our DICOM
Conformance Statement included in the “Technical Manual”.
2-2 Ziehm 7000 Plus
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2.2 Model range
Note
This manual describes all models in their corresponding maximum
configuration.
The system configuration chosen by you may not contain all options and
functions described here.
2.2.1 Ziehm 7000 Plus
for max. 150 or 1,000 images; separate monitor cart with single 23" flatscreen monitor with split screen, optionally with twin 18" flat-screen
monitors.
2 System Overview
FeaturesWith 31 cm, 23 cm or 15 cm image intensifier; storage capacity optionally
2.2.2 Ziehm 7000 Plus (Compact Version)
images; 18" flat-screen monitor mounted on the C-arm stand, with small
video printer laterally.
FeaturesWith 23 cm or 15 cm image intensifier; storage capacity for max. 2
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2-3Ziehm 7000 Plus
2 System Overview
2.3 Options
The following options can be integrated into the system upon request:
Hardware options − Ziehm 7000 Plus (Compact Litho Version):
− 23 cm image intensifier
− storage capacity for max. 2 images
− 18" flat-screen monitor mounted on the C-arm stand, with small
video printer laterally
− mounting plate for lithotripter on the C-arm stand
− C-arm stand with lower C-arm position
− Laser positioning device on the generator
− Laser positioning device on the image intensifier
integrated (23 / 31 cm i.i.) or external (15 cm i.i.)
− Dose measurement chamber for measuring the dose area product
− Active Cooling
− Key switch
− EMERGENCY STOP button
− CD writer
− Video printer Sony
®
UP-960
for printout on paper
− Video printer Sony
®
UP-980
for printout on paper or transparent film
− S-VHS video cassette recorder
− Connection for external radiation warning lamp (including software)
− Barcode reader
for scanning patient data from patient ID labels
− Video output (Ziehm 7000 Plus (Compact Version), Ziehm 7000 Plus
(Compact Litho Version))
− Hand rail around the image intensifier
− Color-coded brake handles
Software options − DICOM 3.0 interface, with support of Print Class, Storage Class
(including multiframe capability), Storage Commitment Class, Media
Class, Worklist Class, MPPS Class, Query/Retrieve Class and
Verification Class, depending on the chosen system configuration.
− Cine loop
− DSA package
2-4 Ziehm 7000 Plus
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− Subtraction angiography program for CO2 negative contrast medium
− Customer-specific foot switch assignment
− S-distortion correction
2.4 Optional accessories
The following accessories are optionally available for the Ziehm 7000
Plus:
− Sterile disposable covers
3-part, for X-ray generator, C-arm and image intensifier, with spring
band or clip fixing
− Spring bands for disposable covers
− Clips for disposable covers
2 System Overview
1 set = 6 pieces
− Hand surgery table
− Universal film cassette holder
− Foot switch cover
− Printer paper for Sony
− Printer paper for Sony
®
UP-960
®
UP-980
− Printer transparent film for Sony
®
UP-980
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2-5Ziehm 7000 Plus
2 System Overview
2.5 Parts of the system
2.5.1 Mobile C-arm stand
Ziehm 7000 Plus
Image intensifier with integrated CCD camera
C-arm handle
C-arm
Swivel arm
Horizontal carriage
Lifting column
Control panel
Steering &
braking lever
Handle
Hand switch
Coupling
cable
connection
Cable guards
Fig. 2-1 Ziehm 7000 Plus C-arm stand
Cassette holder
X-ray generator
2-6 Ziehm 7000 Plus
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2.5.2 Monitor cart
2 System Overview
Radiation
warning lamp
Flat-screen
monitor
Control
panel
Video printer
Brakes
Coupling cable
support
Power cable
support
Power supply
connection
Coupling cable
connection
VIDEO OUT
Equipotential
grounding
Spare earth
ground
connection
Fig. 2-2 Ziehm 7000 Plus monitor cart with 23" flat-screen monitor
Ziehm 7000 Plus
with 23" flat-screen
monitor
Radiation
warning lamp
Flat-screen
monitors
Button panels
for monitor
settings
Control panel
Video printer
FD drive
CD writer
Brakes
TX/RX connection
ON/OFF
switches for flatscreen monitors
Coupling
cable support
DICOM
connection
Power cable
support
Power supply
connection
Coupling cable
connection
VIDEO OUT
Equipotential
grounding
Spare earth
ground
connection
Fig. 2-3 Ziehm 7000 Plus monitor cart with 18.1" flat-screen
monitors
Ziehm 7000 Plus
with 18.1" flatscreen monitors
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2-7Ziehm 7000 Plus
2 System Overview
2.5.3 Ziehm 7000 Plus (Compact Version)
Ziehm 7000 Plus
(Compact Version)
with flat-screen
monitor
Image intensifier with integrated CCD camera
Radiation warning lamp
Compact monitor
Video printer
Horizontal carriage
Lifting column
Control panel
Steering & braking
lever
Handle
Hand switch
Connection for
power cable or
coupling cable
Cable guards
Cassette holder
C-arm handle
C-arm
Monitor support arm
Swivel arm
X-ray generator
Fig. 2-4 Ziehm 7000 Plus (Compact Version) with flat-screen
monitor
Ziehm 7000 Plus
(Compact Litho
Version)
Image intensifier with integrated CCD camera
Radiation warning lamp
Compact monitor
Video printer
Horizontal carriage
Lifting column
Mounting plate for
lithotripter
Control panel
Steering & braking
lever
Handle
Hand switch
Connection for
power cable or
coupling cable
Cable guards
C-arm handle
C-arm
Monitor support arm
Swivel arm
Fig. 2-5 Ziehm 7000 Plus (Compact Litho Version)
Cassette holder
X-ray generator
2-8 Ziehm 7000 Plus
28140-4_22.02_EN_00
2.5.4 Monitors
2 System Overview
On the Ziehm 7000 Plus, the left screen has been factory-set as the live
screen and the right screen as the reference screen.
During operation, the following information is displayed on the screens:
• Live screen: Fluoroscopic image
• Reference screen: Menus or reference images
You can change the screen assignment in the Basic Settings menu
(→ Ch. 19.3, p. 19-6).
Note
To avoid confusion, the neutral terms ‘live screen’ and ‘reference
screen’ are used throughout this manual, regardless of your custom
setting.
brightness and other settings of the monitors with the buttons integrated
in them (→ Ch. 19.4.2, p. 19-9).
The Ziehm 7000 Plus (Compact Version) is equipped with one monitor
only, which is mounted on the horizontal carriage of the C-arm stand with
an easily adjustable support arm.
On a Ziehm 7000 Plus (Compact Version) with flat-screen monitor or a
Ziehm 7000 Plus (Compact Litho Version), a small video printer is built
into the left side of the monitor (when looking onto the monitor screen).
Ziehm 7000 Plus
screen assignment
Monitor settingsOn a system with flat-screen monitors, you can modify the contrast,
Ziehm 7000 Plus
(Compact Version),
Ziehm 7000 Plus
(Compact Litho
Version)
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2-9Ziehm 7000 Plus
2 System Overview
2.5.5 Video output
BNC socket A BNC socket which is used for video connection (VIDEO OUT) is
located on the rear of the monitor cart.
VIDEO OUT The VIDEO OUT socket supplies a CCIR video signal of the live screen
image. The following image is available for further processing by a video
cassette recorder, an external monitor, a video printer, etc.:
• Fluoroscopic image (live or saved)
WARNING
Supplementary equipment used in combination with the Ziehm 7000
Plus 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.
If you combine the Ziehm 7000 Plus with equipment which does not
comply with these requirements, the safety of the whole system is no
longer given and the warranty will become invalid.
2-10 Ziehm 7000 Plus
28140-4_22.02_EN_00
Safety Instructions 3
3.1 General safety instructions
WARNING
You must be familiar with the contents of this user manual in order to be
able to operate the system as intended. Study this user manual
thoroughly before operating the system.
It is important to observe all directions, safety instructions and warnings!
WARNING
Supplementary equipment used in combination with the Ziehm 7000
Plus 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.
If you combine the Ziehm 7000 Plus with equipment which does not
comply with these requirements, the safety of the whole system is no
longer given and the warranty will become invalid.
Only authorized personnel are allowed to assemble the system and to
provide technical service. The necessary qualifications can only be
obtained by attending a training course provided by the manufacturer.
OperationOnly properly trained personnel are allowed to operate the system.
Assembly and
service
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3-1Ziehm 7000 Plus
3 Safety Instructions
CAUTION
Always observe the relevant regulations of the country of installation for
putting the system into service, training of personnel and maintenance.
WARNING
Never use the system if you suspect any electrical or radiationgenerating components to be defective!
WARNING
Never pull at the power cable or coupling cable of the monitor cart in
order to move the cart to another position.
Otherwise severe equipment damage may result.
CAUTION
Always use the CUT button on the video printer for cutting off printer
paper.
Tearing off the printer paper may damage the video printer.
WARNING
Before opening any part of the equipment or removing the protective
covers, you must disconnect the system from the power supply.
3.2 X-rays
General The system produces X-rays, which can be hazardous both to operating
staff and other persons within the radiation zone of occupancy if the
safety measures and precautions required by the relevant national
radiation protection regulations (e.g. X-Ray Ordinance in Germany) are
not observed.
WARNING
The system may only be operated by personnel who has undergone
radiological training.
3-2 Ziehm 7000 Plus
28140-4_22.02_EN_00
CAUTION
The relevant safety regulations of the country of installation must be
observed.
WARNING
In order to avoid unintentional radiation, the foot switch must be hung up
on the foot switch support when the system is switched on, but not in
use.
ray protective clothing.
The radiation controlled area depends upon the size of the image
intensifier installed and has the following radius:
• 15 cm image intensifier: 3 m
3 Safety Instructions
Protection of staffStaff members who stay within the radiation controlled area must wear X-
• 23 cm image intensifier: 4 m
• 31 cm image intensifier: 4 m
(→ Fig. A-16, p. A-23)
To minimize the radiation burden of the patient, you must keep the focusskin distance as large as possible. The generator design guarantees a
minimum focus-skin distance of 20 cm.
WARNING
Additional material located in the beam path (e.g. an operating table not
suitable for X-raying) may result in a dose increase when using a
fluoroscopy mode with automatic exposure rate control.
WARNING
When you initiate radiation and no live image is displayed, although all
necessary settings have definitely been made, please contact your
after-sales service center!
Protection of the
patient
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3-3Ziehm 7000 Plus
3 Safety Instructions
3.3 Electromagnetic compatibility
Medical electrical equipment requires special precautionary measures
with respect to EMC and must be installed and put into service in
accordance with the EMC guidelines contained in the accompanying
documents.
Portable and mobile RF communications equipment may interfere with
medical electrical equipment.
All operating modes of the system have been considered in the EMC
tests. There are no exceptions to the rules.
Only conductors, connecting cables and accessories that are specified
by the manufacturer may be used.
WARNING
Using components other than those specified may result in increased
electromagnetic emissions or reduced electromagnetic immunity.
3.4 Protective grounding
The system must be connected only to power systems having a separate
ground connection.
3.5 Equipotential grounding
Heart and brain
examinations
If the system is used in combination with other equipment for
examinations of the heart or brain or the surrounding anatomical regions,
equipotential grounding is required for patient and operating staff safety
(IEC 60601-1-1:1992/A1:1995).
3-4 Ziehm 7000 Plus
28140-4_22.02_EN_00
3.6 Laser radiation
3 Safety Instructions
As an option, the system may be equipped with a laser positioning device
at the image intensifier and/or generator.
The laser positioning device uses diode laser modules which emit laser
radiation. Do not under any circumstances look directly at the laser
beam or any scattered laser radiation – either with the naked eye or with
optical instruments.
The laser positioning device is a Class 2M laser product according to IEC
60825-1:2003. Make sure to comply with all operating safety precautions
when using the laser positioning device.
The maximum output of continuous laser radiation, measured at the
beam exit, is <1 mW. The wavelength of the emitted radiation is 635 nm.
WARNING
Laser radiation! Do not look directly or with optical instruments into the
laser beam apertures, since doing so can be hazardous to your eyes!
repair which might become necessary must be carried out by the
manufacturer or a suitable qualified service engineer who has received
appropriate training from the manufacturer.
Laser positioning
device
MaintenanceThe laser positioning device is maintenance-free. Any adjustment or
Laser beam apertures
Laser beam apertures
Fig. 3-1 Laser beam apertures on an image intensifier with external
laser positioning device (left) and on the generator (right)
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3-5Ziehm 7000 Plus
3 Safety Instructions
Laser beam apertures
Laser beam apertures
Fig. 3-1 Laser beam apertures on an image intensifier with
integrated laser positioning device (left) and on the
generator (right)
3.7 Environmental compatibility
The system does not produce any waste during operation.
When the system has reached the end of its useful service life, the
relevant waste disposal regulations must be observed.
3-6 Ziehm 7000 Plus
28140-4_22.02_EN_00
Putting the System into Service 4
4.1 Unpacking the system
Detailed instructions of how to unpack and assemble the system are
supplied with the system.
WARNING
Only authorized personnel (→ p. 1-2) are allowed to unpack and
assemble the system.
During assembly, the system may be handled only by trained personnel
who have studied the contents of Ch. 4, Putting the System into Service
and Ch. 5, Mechanical Handling.
have reached room temperature before the system is put into service in
order to avoid damage to the system as a result of condensation.
WARNING
The cooling tank may have been emptied before shipping for transport
temperatures below 0°C. In this case, you must refill the cooling tank
with water with the help of the filler and vent hoses before putting the
system into service. Check whether there is already water in the tank.
Detailed
information
Room temperatureIn case of major differences in temperature, all parts of the system must
WARNING
Do not operate the system until the equipment has reached a safe
operating temperature of +15°C to +35°C with no condensation present.
Otherwise severe equipment damage may result.
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4-1Ziehm 7000 Plus
4 Putting the System into Service
4.2 Accessories
Depending on the integrated options, the following accessories are
included in the scope of delivery:
All systems
Accessory item Qty.
User Manual 2
Technical Manual 1
Specifications and Certificates 1
Coupling cable (7.5 m) 1
Equipotential grounding cable (6 m) 1
Video printer
Operating instructions for video printer 1
Printer paper 1 roll
Printer transparent film
(only Sony
®
UP-980)
Video cassette recorder
Operating instructions for video cassette
recorder
Video cassette S-VHS (240 min.) 1
CD writer
Options
CD (640 MB)
DICOM
RJ45 interface with Cat.5 patch cable
(10 m)
Fiber-optic connection (FOC):
ST coupling, 10base-FL or 100base-FX
Active Cooling
Filler and vent hose (1.5 m) 2
Table 4-1 Accessories
1 roll
1
1
1
1
4-2 Ziehm 7000 Plus
28140-4_22.02_EN_00
4 Putting the System into Service
4.3 Cable connections
you must establish different cable connections.
• Unwind the coupling cable from the upper cable support on the back
of the monitor cart (→ Fig. 2-2, p. 2-7 / → Fig. 2-3, p. 2-7).
• Plug the coupling cable connector into the socket located at the side
of the C-arm stand and lock the connector by pulling the locking lever
upward (→ Fig. 2-1, p. 2-6).
• Make sure that a suitable supply voltage is available and that the
socket-outlet is properly grounded and fused.
• Check the power plug on the monitor cart power cable (→ Fig. 2-2,
p. 2-7 / → Fig. 2-3, p. 2-7) and the socket-outlet for compatibility.
GeneralBefore switching on the system for the first time, or after each transport,
Ziehm 7000 PlusDo the following:
• Connect the system to the power supply.
WARNING
Never connect the monitor cart and C-arm stand when the monitor cart
is already connected to the power supply or switched on.
Damage to the electronics of the system cannot be excluded if this
warning is ignored!
On a Ziehm 7000 Plus (Compact Version) or Ziehm 7000 Plus (Compact
Litho Version), do the following:
• Unwind the power cable from the combined foot switch/power cable
support located at the side of the C-arm stand (→ Fig. 2-1, p. 2-6).
• Plug the power cable connector into the socket located at the side of
the C-arm stand and lock the connector by pulling the locking lever
upward.
• Make sure that a suitable supply voltage is available and that the
socket-outlet is properly grounded and fused.
• Check the power plug and the socket-outlet for compatibility.
Ziehm 7000 Plus
(Compact Version),
Ziehm 7000 Plus
(Compact Litho
Version)
• Connect the system to the power supply.
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4-3Ziehm 7000 Plus
4 Putting the System into Service
4.4 First power-up of the system
Preparation • Make sure that the inclination of the system does not exceed 5° from
the level in operating position.
• Ensure that all electrical connections are properly established
(→ Ch. 4.3, p. 4-3).
• Put on suitable protective clothing.
• Switch on the system.
You can find an ON key and an OFF key on the control panels of both
the C-arm stand (→ Fig. 6-1, p. 6-1) and the monitor cart (→ Fig. 6-2,
OFF ON
Power-up During power-up, the system performs a self-test. The value 0 appears
p. 6-6). Each of the two ON and OFF keys simultaneously switches
on or off both system components.
on the operating value displays. The radiation time display shows the
global software version of the system. The temperature symbol
(→ Fig. 6-1, p. 6-1) and the X-ray symbol (→ Fig. 6-1, p. 6-1) on the Carm stand control panel illuminate for a few seconds.
After power-up, a test image appears on the live screen. The default
settings after power-up vary from system to system, according to the
customer-specific setup.
Note
Due to background radiation, the dose area product display on the C-
arm stand (if enabled) may indicate some small value after power-up of
the system.
To reset the display to zero, press and hold down the min key on the Carm stand control panel for a few seconds.
Note
As part of the power-up sequence, the radiation warning lamp may light
up. This is a system test and does not mean that radiation is released.
4-4 Ziehm 7000 Plus
28140-4_22.02_EN_00
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