Ziehm Vision and Vision FD User Manual Rev July 2005

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.

Operation (U.S.A.)

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

Authorized personnel

Only authorized personnel are allowed to assemble and/or 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.

The warranty becomes invalid in case that any repair, modification or installation work is carried out by unauthorized personnel. No consequential damages will be accepted either. The equipment conforms to Class IIb according to the Council Directive 93/42/EEC. This user manual has been written and reviewed originally in German and translated.

Copyright Copyright © 2005 Ziehm Imaging GmbH 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 may be updated at regular intervals and is subject to change without prior notice. Manufactured by: Ziehm Imaging GmbH Donaustr. 31 D-90451 Nuremberg (Germany) e-mail: [email protected] http://www.ziehm.com

In the U.S.A.: Ziehm Imaging, Inc. 4181 Latham Street Riverside, CA 92501 e-mail: [email protected]

Rev. 07/2005

Ziehm Vision 26366-5_4.12_EN_00

Table of Contents Table of Contents

I

1

About this Manual

1-1

2

System Overview 2.1 Fields of application... 2.2 Features ... 2.3 Options ... 2.4 Options (U.S.A.) ... 2.5 Optional accessories ... 2.6 Optional accessories (U.S.A.) ... 2.7 Parts of the system... 2.7.1 C-arm stand ... 2.7.2 Monitor cart ... 2.7.2.1 Monitor cart with 18.1" flat-screen monitors... 2.7.2.2 Monitor cart with CRT monitors ... 2.7.3 Twin monitors... 2.7.4 Monitor settings on a Ziehm Vision with flat-screen monitors ... 2.7.4.1 Integrated button panel... 2.7.4.2 Setting the brightness, contrast and backlight brightness . 2.7.4.3 Setting the menu language... 2.7.4.4 Restoring the factory settings ... 2.7.5 Video output ...

2-1 2-1 2-1 2-4 2-5 2-6 2-6 2-7 2-7 2-9 2-9 2-10 2-11 2-12 2-12 2-12 2-14 2-15 2-16

3

Safety Instructions 3.1 General safety instructions... 3.2 X-rays ... 3.3 Electromagnetic compatibility... 3.4 Protective grounding ... 3.5 Equipotential grounding... 3.6 Laser radiation... 3.7 Environmental compatibility...

3-1 3-1 3-2 3-3 3-4 3-4 3-5 3-6

4

Putting the System into Service 4.1 Unpacking the system ... 4.2 Accessories ... 4.3 Cable connections... 4.4 First power-up of the system ... 4.5 Setting up the system...

4-1 4-1 4-2 4-3 4-3 4-4

5

Mechanical Handling 5.1 Transport position... 5.1.1 C-arm stand transport position... 5.1.2 Monitor cart transport position... 5.2 Braking and steering the monitor cart ... 5.3 Braking and steering the C-arm stand... 5.4 C-arm movements... 5.4.1 Orbital rotation ...

5-1 5-1 5-1 5-2 5-4 5-5 5-6 5-7

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5.4.2 5.4.3 5.4.4 5.4.5

Angulation ... 5-8 Swiveling (panning) ... 5-9 Horizontal movement ... 5-10 Vertical movement... 5-11

6

Controls 6-1 6.1 Vision Center control panel ... 6-1 6.1.1 Elements of the control panel... 6-1 6.1.2 Controls in the Fluoroscopy and Subtraction operating modes... 6-2 6.2 Switches on the unit ... 6-9 6.3 Hand switch and foot switch ... 6-10

7

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

7-1 7-1 7-2 7-3 7-4

8

Standard Fluoroscopic Operations 8.1 Overview... 8.2 Fluoroscopy modes ... 8.2.1 Continuous pulse fluoroscopy ... 8.2.2 Digital radiography (snapshot) ... 8.3 Manual exposure rate setting ... 8.4 Fluoroscopy programs... 8.4.1 Anatomical programs ... 8.4.2 Metal artifact correction function ... 8.4.3 Reposition function... 8.4.4 High quality function ... 8.4.5 Large patient function... 8.5 Screen display during radiation ... 8.6 Dose area product ... 8.7 Saving... 8.8 Printing the live monitor image ... 8.9 Warning signals and faults ... 8.9.1 Permanent warning during radiation ... 8.9.2 Interval warning during radiation ... 8.9.3 Temperature monitoring ... 8.9.4 Error and alert messages ...

8-1 8-1 8-2 8-2 8-4 8-5 8-7 8-7 8-8 8-8 8-8 8-9 8-9 8-10 8-10 8-12 8-13 8-13 8-13 8-14 8-14

9

Adjusting Live Images 9.1 Overview... 9.2 Contrast and brightness settings for the CRT monitors... 9.3 Contrast and brightness adjustment of individual images (windowing) ... 9.4 Filters... 9.4.1 Recursive filter... 9.4.2 Edge filter ... 9.4.3 Stack filter ... 9.5 Electronic image magnification... 9.6 Digital image zooming ... 9.7 Grayscale inversion ... 9.8 Collimation... 9.8.1 Iris collimator ...

9-1 9-1 9-2 9-4 9-7 9-7 9-8 9-9 9-10 9-11 9-13 9-13 9-13

II

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9.8.2 Slot collimator ... 9.8.3 Virtual collimator... 9.9 Image swapping ... 9.10 Image reversal and image rotation... 9.10.1 Horizontal and vertical image reversal ... 9.10.2 Image rotation ...

9-14 9-15 9-15 9-16 9-16 9-17

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 Generated patient folders ... 10-2 10.2 Managing patient data... 10-2 10.2.1 Creating a new patient folder on the Ziehm Vision ... 10-3 10.2.1.1 Entering patient data manually ... 10-4 10.2.2 Modifying patient data ... 10-5 10.3 Image data management ... 10-7 10.3.1 Processing patient folders... 10-8 10.3.2 Finding and displaying a patient folder... 10-15 10.3.3 Activating a patient folder... 10-17 10.3.4 Browsing through the active patient folder ... 10-20 10.3.5 Processing and outputting images in a patient folder ... 10-20 10.3.6 Comparing saved images ... 10-29 10.3.7 Making backup copies of patient folders ... 10-30 10.3.7.1 Backup to USB storage device ... 10-31 10.3.7.2 Backup to CD or DVD... 10-34

11

DICOM Functions 11-1 11.1 Prerequisites ... 11-1 11.2 Downloading patient data from a DICOM server... 11-1 11.2.1 Query ... 11-1 11.2.2 Downloading a Worklist... 11-2 11.2.2.1 Downloading a Worklist for a specific time span ... 11-3 11.2.2.2 Downloading a patient-specific Worklist ... 11-4 11.2.2.3 Downloading a Worklist for a procedure step ... 11-6 11.3 Saving images from one or several patient folders ... 11-8 11.3.1 Saving and printing images and cine loops... 11-9 11.4 Saving or printing single cine loop images ... 11-11 11.5 Importing images and cine loops from a DICOM server ... 11-12

12

Cine Loops 12-1 12.1 Overview ... 12-1 12.2 Generating a cine loop ... 12-1 12.3 Opening a saved cine loop... 12-4 12.4 Controlling and editing a cine loop during playback ... 12-6 12.5 Processing and outputting saved cine loops ... 12-8 12.6 Processing and outputting single cine loop images ... 12-15

13

Subtraction Modes 13.1 Overview ... 13.2 Acquiring a DSA cine loop... 13.3 Acquiring an MSA image... 13.4 Acquiring an RSA image ...

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III

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13.5 Generating MSA and RSA images from a saved DSA cine loop ... 13-7 13.5.1 Opening and postprocessing a DSA cine loop in an active patient folder ... 13-7 13.5.2 Opening and postprocessing any DSA cine loop ... 13-8 13.6 Editing a DSA cine loop... 13-11 13.7 Pixel shift ... 13-13 13.8 Landmarking... 13-14 14

Post-Processing Images 14-1 14.1 Overview... 14-1 14.2 Activating the post-processing functions ... 14-3 14.3 Contrast and brightness settings for the CRT monitors... 14-4 14.4 Contrast and brightness adjustment of individual images (windowing) ... 14-5 14.5 Edge filter ... 14-8 14.6 Digital image zooming ... 14-9 14.7 Grayscale inversion ... 14-11 14.8 Image rotation... 14-11 14.9 Horizontal and vertical image reversal ... 14-11 14.10 Digital collimation (image crop) ... 14-12 14.11 Marking and deleting images... 14-12 14.12 Outputting images ... 14-15

15

Measurements 15-1 15.1 Measuring functions ... 15-1 15.2 Calibrating ... 15-3 15.3 Measuring a length or distance ... 15-5 15.4 3-point measurement... 15-8 15.5 4-point measurement... 15-11 15.6 4-point ratio measurement... 15-15

16

Displayed Texts and Text Functions 16.1 Overview... 16.2 Image information on the monitor... 16.2.1 Upper left corner of the monitor... 16.2.2 Upper right corner of the monitor ... 16.2.3 Lower left corner of the monitor... 16.2.4 Lower right corner of the monitor ... 16.3 Entering and editing text...

16-1 16-1 16-1 16-1 16-1 16-2 16-3 16-4

17

Image Documentation 17.1 Overview... 17.2 Output to video printer ... 17.3 Record and playback on video cassette recorder ...

17-1 17-1 17-1 17-2

18

Laser Positioning Device 18-1 18.1 Applications ... 18-1

19

Direct Radiography 19.1 Overview... 19.2 Fitting the film cassette holder... 19.3 Making a direct radiographic exposure...

IV

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

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20

System Configuration 20-1 20.1 Overview ... 20-1 20.2 Operation settings ... 20-2 20.2.1 Autotransfer ... 20-2 20.2.2 Autostore... 20-3 20.2.3 Displaying a crosshair ... 20-4 20.2.4 Defining the start screen ... 20-5 20.2.5 Cine loop settings ... 20-6 20.2.6 Showing or hiding the native image ... 20-7 20.2.7 Discarding the operation settings... 20-7 20.3 Basic settings ... 20-8 20.3.1 Setting the system date and the system time ... 20-8 20.3.2 Determining the live monitor ... 20-9 20.3.3 Entering the hospital data ... 20-10 20.3.4 Discarding the basic settings ... 20-11 20.4 Monitor / Dose ... 20-11 20.5 Storage media ... 20-13 20.5.1 Floppy disk storage format... 20-14 20.5.2 Defining the USB device storage format ... 20-14 20.5.3 Defining the CD / DVD storage format ... 20-15 20.5.4 Deleting data from storage media ... 20-16

21

C-Arm Power Assist (U.S. Option) 21.1 Function... 21.2 Operating instructions ... 21.3 Using the C-arm Power Assist ...

21-1 21-1 21-1 21-2

Appendix A.1 Regular checks... A.1.1 Routine checks to be performed by the user ... A.1.2 Consistency test according to national regulations ... A.1.3 Checking the exposure rate control ... A.1.4 Dose meter check (optional feature) ... A.1.5 Checking the useful beam ... A.1.6 Leakage in the cooling system... A.1.7 Gettering the image intensifier tube (n/a for Ziehm Vision FD) ... A.1.8 Gain adjustment and pixel correction (Ziehm Vision FD)... A.2 Cleaning, disinfection, sterilization ... A.2.1 Cleaning ... A.2.2 Disinfection ... A.2.3 Sterilization ... A.3 Faults... A.3.1 Types of faults... 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 List of errors and alerts ... A.4 Labels on the Ziehm Vision ... A.5 Focal spot position ... A.5.1 Ziehm Vision ... A.5.2 Ziehm Vision FD... A.6 Heat capacity...

A-1 A-1 A-1 A-2 A-2 A-2 A-4 A-5 A-5 A-5 A-6 A-6 A-6 A-7 A-7 A-7 A-7 A-7 A-8 A-8 A-8 A-16 A-26 A-26 A-27 A-28

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Table of Contents

A.7

Scattered radiation in the significant zone of occupancy... A.7.1 Ziehm Vision ... A.7.2 Ziehm Vision FD... A.8 Dimensions... A.9 Technical data ... A.9.1 Ziehm Vision ... A.9.2 Laser positioning device... A.9.3 Dose measurement chamber ... A.10 Labels on the Ziehm Vision (U.S.A.) ... A.11 Technical data Ziehm Vision (U.S.A.)... A.12 Technical data Ziehm Vision (Japan) ... Index

VI

A-29 A-29 A-30 A-31 A-35 A-35 A-39 A-39 A-40 A-48 A-51 i

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1

About this Manual This manual is designed to enable owners and operators of a Ziehm Vision or Ziehm Vision FD to operate the systems described herein safely and efficiently.

Purpose of this manual

Ziehm Vision and Ziehm Vision FD, software version 4.

Scope of validity of this manual

For several system options, 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.

Separate operating instructions

Typographical conventions In this manual, the following notations and formats will be used to highlight certain elements of the Vision Center control panel or the documentation itself: Element

Format

Example

Vision Center elements (buttons, symbols and boxes), operating modes, functions

Bold

Post Process

Cross-references

Italic, preceded by an arrow

→ Ch. 20, p. 20-1

Steps of a procedure

Preceded by a •

• Press the OK button.

Table 1-1

Notations and formats used in this manual

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1 About this Manual

Hints and warnings

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

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2

System Overview 2.1

Fields of application

The Ziehm Vision is a mobile C-arm X-ray image intensifier which is suitable for all surgical applications in traumatology, orthopedics, neurology, urology and cardiology, for use in gastroenterology and for all vascular applications.

Applications

The Ziehm Vision FD is suitable for more demanding vascular interventions requiring a high level of precision, e.g. in the field of neurology.

Ziehm Vision FD

2.2

Features

With its compact design and combined steering & braking system, the Ziehm Vision offers unrestricted mobility at the operating table, even if space is scarce.

Mobility

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 optimal 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.

Anatomical programs

The superior penetration capabilities of the digital high-frequency generator enable a significant reduction in the patient skin dose.

Radiation dose reduction

Radiation-free collimation is provided by the system’s ‘Virtual Collimator’. 18" flat-screen monitors or optionally 1000 cd2 CRT monitors with antireflection coating which are based on 150 Hz technology (U.S.A.: 90 Hz non-interlaced) 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.

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Image quality

2-1

2 System Overview

Ziehm Vision FD

The Ziehm Vision FD 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).

Active Cooling

The Active Cooling system 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. For filmless archiving, the following devices are available: − Floppy disk drive − CD writer or DVD writer − USB port Images can be stored in the following formats: − PC-compatible BMP format (floppy disk) − PC-compatible TIF format − PC-compatible JPEG format with reduced resolution and reduced color depth − DICOM format − DICOM format with reduced resolution and reduced color depth − Multimedia format: Video CD format (CD) or MPEG2 format (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.

2-2

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2 System Overview

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 available: Print, Storage (including multiframe capability), Media, Worklist, 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 “Technical Manual”.

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2 System Overview

2.3

Options This manual describes a system with maximum configuration. The system configuration chosen by you may not contain all options and functions described here. The following options can be integrated into the system upon request: − DICOM 3.0 interface Ziehm NetPort (Primary Capture) Depending on the chosen system configuration, the following DICOM Classes are supported: − Print Class − Storage Class including multiframe capability − Media Class − Worklist Class − Query/Retrieve Class − Verification Class − Dose measurement chamber for measuring the dose area product − Laser positioning device on the generator and/or image intensifier or digital flat-panel detector − Key switch − EMERGENCY STOP button − Connection for external separate radiation warning lamp (including software) − Codonics laser printer (EP 1660) − Codonics laser printer (NP 1660 MD) − S-VHS video cassette recorder with automatic recording control (Sony® SVO-9500MDP) − Video printer Sony® UP-895 or UP-960 (for printout on paper) or UP-980 (for printout on paper or transparent film) − CRT monitors − USB port − CD writer or DVD writer

2-4

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2.4

Options (U.S.A.)

This manual describes a system with maximum configuration. The system configuration chosen by you may not contain all options and functions described here. The following options can be integrated into the system upon request: Hardware options: − CD writer − Video printer Sony® UP-895 or UP-960 (for printout on paper) or UP-980 (for printout on paper or transparent film) − Codonics laser printer (EP 1660) − Laser positioning device on the generator and/or image intensifier − Dose measurement chamber for measuring the dose area product − Vision Center located in the monitor cart Optional functions: − Measurements − DSA − CINE with 5/10/15/30 frames per second (30 frames per second only with DSA option) − Additional image storage: 5,000/10,000/20,000/50,000 images (50,000 images only with DSA option) − DICOM 3.0 interface Ziehm NetPort (Primary Capture) Depending on the chosen system configuration, the following DICOM Classes are supported: − Print Class − Storage Class including multiframe capability − Media Class − Worklist Class − Query/Retrieve Class (patient level) − Query/Retrieve Class (study level) − Query/Retrieve Class (series level) − Query/Retrieve Class (image level) − Verification Class − Dose area product display

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2 System Overview

2.5

Optional accessories The following accessories are optionally available for the Ziehm Vision: − Sterile disposable covers for all sizes − Hand surgery table (n/a for Ziehm Vision FD) − Universal film cassette holder (n/a for Ziehm Vision FD) − Foot switch cover

2.6

Optional accessories (U.S.A.) − Hand surgery table − Universal film cassette holder − C-arm power assist (→ Ch. 21, p. 21-1)

2-6

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2.7

Parts of the system

2.7.1

C-arm stand C-arm

Image intensifier with integrated CCD camera

Ziehm Vision

Vision Center control panel C-arm handle Horizontal carriage Lifting column

Cassette holder Swivel arm

Steering & braking lever X-ray generator

Handle Hand switch Coupling cable connection

Cable guards

Fig. 2-1

Mobile C-arm stand of Ziehm Vision

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2 System Overview

Ziehm Vision FD

C-arm Vision Center control panel

Digital flat-panel detector

C-arm handle

Horizontal carriage Lifting column Steering & braking lever

Swivel arm

X-ray generator

Handle Hand switch

Coupling cable connection Cable guards

Fig. 2-2

2-8

Mobile C-arm stand of Ziehm Vision (Ziehm Vision FD)

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2 System Overview

2.7.2

Monitor cart

2.7.2.1 Monitor cart with 18.1" flat-screen monitors Front view Radiation warning lamp Flat-screen monitors Button panels for monitor settings

Button panels for monitor settings

Floppy disk drive CD writer or DVD writer

Control panel

Video printer

USB port

Foot lever for braking and direction locking

Fig. 2-3

Foot lever for braking and direction locking

Monitor cart with 18.1" flat-screen monitors, front view Rear view

Coupling cable support

Power cable support

DICOM port (optional)

VIDEO OUT DICOM port (optional)

TX/RX connection

Coupling cable connection

Power supply connection

Equipotential grounding Spare earth ground connection

Fig. 2-4

Monitor cart with 18.1" flat-screen monitors, rear view

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2 System Overview

ON

OFF

On the rear side of each flat-screen monitor, there is an ON/OFF switch.

CAUTION Always set the ON/OFF switches on the flat-screen monitors to ON in order to ensure that the monitors are switched on automatically during power-up of the system.

Movement of the flat-screen monitors

The flat-screen monitors are mounted on a pivot and can be swiveled by approx. 15° to the right or to the left.

2.7.2.2 Monitor cart with CRT monitors Front view

Radiation warning lamp Twin monitors

Control panel

Floppy disk drive CD writer or DVD writer USB port

Video printer

Foot lever for braking and direction locking

Foot lever for braking and direction locking

Fig. 2-5

2-10

Monitor cart with CRT monitors, front view

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