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It does not, however, continuously check for any changes which could form the basis for liability. If Carl Zeiss Meditec AG determines that a link which it has incorporated could result in civil or criminal liability, or is alerted to the fact by a third party, the link will be removed.
Contents Contents Contents ..................1 Notes on the user manual ............3 Purpose and availability of documentation ............ 3 Questions and comments ................3 Explanation of symbols used ................4 Package check list ..............5 Country-specific information and labels ........6 Classification/Manufacturer's declaration ............
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Contents Notes on angiography ............. 36 Angiography using the CIRRUS photo 800 ..........36 Maintenance and care ............. 37 Fault remedy ....................37 Replacing the flashing diode of the external fixation lamp ......38 Maintenance ....................39 Care and cleaning ........................39 Data backup ....................
CIRRUS photo is readily available. Questions and comments If you have any questions or comments concerning this user manual or the CIRRUS photo, please contact ZEISS service or your local dealer. (Contact details see reverse.) 000000-2121-813-GA-GB-050416...
Notes on the user manual Explanation of symbols used The symbols used in this user manual refer to important safety information which warn against possible health risks or fatal injuries and contain useful notes. Whenever you see these symbols, read the accompanying information carefully and observe all safety notes and information in this user manual and on device labels.
Package check list Package check list The following components are included in the CIRRUS photo delivery package: • Documentation set • Basic device, consisting of: – Main unit – OCT engine • Power module with power isolation transformer • Instrument table •...
Country-specific information and labels Country-specific information and labels Classification/Manufacturer's declaration WARNING - GENERAL HAZARDS This device may only be set up, operated and used for the specified purpose and according to national regulations, consistent with the applicable industry standards and occupational safety and accident prevention regulations.
Country-specific information and labels Intended use The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non- mydriatic conditions.
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Country-specific information and labels CAUTION - RISKS ARISING FROM OPERATING ERRORS Do not use the instrument in patients who: • are unable to follow the instructions of the user • are unable to sit upright in front of the instrument •...
Country-specific information and labels Intended user profile CAUTION - RISKS ARISING FROM OPERATING ERRORS This device may only be installed, operated, used and maintained by persons who have been properly trained or who have the required knowledge and experience to do so. Please also adhere to the national qualification guidelines applicable in your country.
Country-specific information and labels Disposal of the product CAUTION - RISK OF ENVIRONMENTAL POLLUTION Packaging materials should be retained for future relocation or repair. If you decide to dispose of the packaging material, submit it to a recognized collection system for recycling. The device contains electronic components.
Country-specific information and labels External labels Fig. 1 Warning and information labels on the device 000000-2121-813-GA-GB-050416...
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CIRRUS photo 600 CIRRUS photo 800 identification label Catalogue number/part number Serial number CIRRUS photo 600 identification label Sign with date of manufacture CE marking label and disposal advise for EU conformity symbol with Identification number of...
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Country-specific information and labels Item Label Explanation Sign with manufacturer's name and date Manufacturer Date of manufacture EU conformity symbol with Identification number of notified body OCT engine type label Sign with date of manufacture Information label "Disconnect device from the power supply before opening"...
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Power module identification label Product number Serial number "24 V output" information label "230 V output" information label Not applicable Not applicable CIRRUS photo 800 main unit identification label Catalogue number/part number Serial number CIRRUS photo 600 main unit identification label 000000-2121-813-GA-GB-050416...
There are special analysis modules which can be used to aid rapid interpretation of OCT scan data. The normative databases and algorithms provided by Carl Zeiss Meditec represent the basis for these modules. As with many medical devices, the CIRRUS photo only offers data storage for a limited period of time.
Performance specifications Service life WARNING - GENERAL HAZARDS The development, production and maintenance of this device, together with associated risks, are based on an expected service life of eight years, assuming that the device is serviced at the specified intervals (see section Inspection of electrical safety, page 46).
Description of the device Description of the device The CIRRUS photo device consists of a fundus camera main unit (9, Fig. 2), an OCT engine (6, Fig. 2), and the power module (7, Fig. 2), all being installed onto an instrument table. It is operated via computer mouse (2, Fig.
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Description of the device 1 Cap for external fixation lamp 2 External fixation lamp, freely (3D) movable (optional for CIRRUS photo 600) 3 Headrest with vertically adjustable chin rest, forehead support and mount for external fixation lamp 4 Display to control the device, monitor the adjustment process, display of examination results and other device...
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Description of the device 1 Monitor 2 Mouse 3 Keyboard 4 Connector panel (see Fig. 5) 5 Rotary knob for adjusting the brightness of the observation light 6 Rotary knob for locking the instrument base 7 Joystick for 3D adjustment of instrument base (X/Y-axis: tilting; Z-axis: rotating), when carrying out coarse adjustment in the X/Y axes, the instrument base is pushed in the desired direction 8 Release button 9 Control panel with quick-select buttons (see Fig.
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Description of the device 1 Sleeve nut for external fixation lamp 2 Red eye level marks (suitable patient eye level for optimum photography) 3 Patient forehead support 4 Front lens with protective cap (exit aperture) 5 Patient chin rest 6 Fastening pins for paper pads 7 Knurled knob for vertical adjustment of chin rest Fig.
Description of the device Connection panel of main unit 4x USB 2.0 ports Connector for additional monitor (DisplayPort) Serial port (not in use) Monitor port (DVI) Connection for external network 2x USB 3.0 ports Connector for communication cable 2x USB 2.0 ports Connector for data transfer cable Power supply input Socket for optical fiber...
Description of the device Connection panel of OCT engine Connector for data transfer cable Socket for optical fiber Connector for communication cable Connector for scanner control Power supply input Fig. 6 Connection panel of OCT engine 000000-2121-813-GA-GB-050416...
Description of the device Power module WARNING - RISK OF ELECTRIC SHOCK Connect the monitor only via the power module and the integrated power isolation transformer (medical power isolation transformer in accordance with IEC 60601-1:2005 with "two MOPP") to the power supply grid. If these instructions are not complied with, there is a risk of electric shock or elimination of the required protective separation between medical devices and non-medical equipment.
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Description of the device 1 Power switch 2 Power control lamp (green) 3 Control lamp for protective conductor (orange) (lights up continuously: phases have been changed; please turn the plug in the power outlet to switch the phases and turn off the control lamp; flashes: protective conductor not connected) Fig.
WARNING - GENERAL HAZARDS First-time operation, installation and relocation of the device are to be carried out by Carl Zeiss Meditec authorized specialists only. The device may not be stored or operated in ambient conditions other than those prescribed (see section Technical data on page 54 and following).
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Installation CAUTION - PROPERTY DAMAGE Do not store or use this device in damp rooms. Do not expose the device to water splashes, dripping water or sprayed water. CAUTION - PROPERTY DAMAGE Handle with care; the instrument should not be lifted or carried! ...
Observe the warning instructions in the user manual of the instrument table. If using a table not approved by Carl Zeiss Meditec AG, the user is solely responsible for ensuring the electrical safety of the instrument. • The power plug must be inserted into a power outlet with an intact protective ground connection.
Daily use Switching on • Switch on the CIRRUS photo using the power switch (1, Fig. 7) on the power module. When the device is turned on at the power switch, it will run through an internal test. Once this has been successfully completed, the Patient dialog is displayed and the device is ready for operation.
Operation of the device Operation of the device WARNING - RISK OF OPTICAL RADIATION The light emitted by this device may be harmful. The risk of eye damage increases with the number of pulses. Exposure at maximum intensity for more than 1933 pulses will exceed the hazard reference value. Do not scan patients who have received treatment which causes increased light sensitivity, e.g.
Operation of the device CAUTION - HAZARD DUE TO MOVING PARTS When lowering the instrument table always ensure that no objects or body parts are within the movement range of the table top. Read the user manual of the instrument table and follow its warning instructions.
Operation of the device Operation using the control panel on the instrument base Internal fixation target/external Switch between internal fixation target fixation lamp (1, Fig. 10) and external fixation lamp Fundus images: Position of the internal fixation Move the fixation target for the patient target (2 and 5, Fig.
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Ensure that the assigned passwords are protected from unauthorized access. Configuration and network settings may only be changed by an experienced network administrator. CAUTION - PROPERTY DAMAGE A forgotten administrator password can only be recovered by ZEISS Service! 000000-2121-813-GA-GB-050416...
A damaged test tool can impair the test results. If the tool is dropped, it should no longer be used for the coalignment test. In this case contact ZEISS Service. Installation of the test tool The test tool (5, Fig. 11) has two adjusting pins (3, Fig. 11), one in the upper right corner and one bottom left.
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Operation of the device 1 Plastic pins 2 Knurled screws 3 Adjusting pins 4 Protective funnel 5 Test tool Fig. 11 Installation of the test tool For further information on carrying out the test please see the software description file in online help, accessible via menu item Help topics in the Help menu.
Notes on angiography Notes on angiography CAUTION - HAZARDS DUE TO SIDE EFFECTS The information of the manufacturer of the injected dye relating to contraindications and side effects must be heeded to prevent incidents during angiography. Angiography using the CIRRUS photo 800 In FA/ICGA capture mode, monochrome images of a patient's eye are generated.
Further maintenance procedures above and beyond those specified in this section (maintenance, safety inspections and repairs) may only be carried out by persons authorized by Carl Zeiss Meditec and solely according to the service instructions issued by Carl Zeiss Meditec. For planning and implementing these maintenance and care procedures please contact ZEISS service or your local dealer.
Maintenance and care Replacing the flashing diode of the external fixation lamp 1 Flashing diode 2 Flashing diode holder Fig. 12 Replacing the flashing diode Unscrew the defective flashing diode (1, Fig. 12) from the holder (2, Fig. 12) and replace it with a new diode. 000000-2121-813-GA-GB-050416...
Maintenance and care Maintenance Care and cleaning WARNING - RISK OF ELECTRIC SHOCK Prevent moisture from penetrating the instrument or keyboard. Disconnect the power cable from the power supply before cleaning or disinfecting the device. CAUTION - RISK DUE TO CROSS-CONTAMINATION Parts with which the patient has come into contact during the examination (chin rest, forehead rest) should be cleaned with a disinfectant approved for the purpose.
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Maintenance and care General information Do not use acetone and acetone-based cleaning agents to clean the device, as they could damage the surfaces. Use spray or wipe disinfectants for cleaning and disinfecting the instrument casing, chinrest and forehead strap. Heavily soiled painted surfaces should be cleaned with a cloth moistened with a weak soap solution.
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® cleaning pen (available from optical retailers or directly supplied by ZEISS, order number 000000-0483-896) • Optical cleaning set (ZEISS, order number 000000-1216-071) or cotton ball sticks or Safebuds from AF International (order number SBU000) Frequent causes of lens contamination •...
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Maintenance and care Fig. 13 Remove dust from front lens Removing splashes of tear fluid Tear fluid drops are usually discernible in the images as light spots. • Apply circular movements with the LensPen (as described in Dust removal, page 41). •...
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Maintenance and care Never allow your fingers to touch the part of the utensil used for cleaning. Hold the cloth between your fingers so they cannot touch the surface of the lens accidentally. Fig. 14 Cleaning with microfiber cloth •...
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Maintenance and care Cleaning not yet optimal Acceptable result Contamination due to a fingerprint Fig. 15 Progress of cleaning The following pictures (Fig. 16) represent how contamination will appear in patient images. The extremely bright spot was caused by An image following moist cleaning. contact with the finger or nose.
Maintenance and care Data backup Storing your image data on the hard disk is no substitute for archiving. We strongly recommend exporting image data daily for backup purposes. Data backup using FORUM Archive Our preferred data archiving solution is the FORUM Archive which stores all data from CIRRUS photo (for configuration see online help file).
When performing the inspection, observe the following instructions or the service instructions issued by Carl Zeiss Meditec. If you wish Carl Zeiss Meditec to perform the inspection, please contact ZEISS Service or your local dealer. Perform the following steps in the given order to perform an electrical safety inspection of the device: •...
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Maintenance and care 1 Measurement point at head rest (screw) 2 Measurement point at instrument base (metallic connector panel) 3 Measurement point at power supply unit (screw) Fig. 17 Testing electrical safety • After successful measurement, the device leakage current must be measured.
For connection to a LAN, a network isolator must be installed (cut-off voltage at least 4 kV). To ensure electromagnetic immunity, only network isolators supplied by Carl Zeiss Meditec may be used. Network isolators and network cables must be installed in accordance with Fig. 18.
Optional accessories Demonstration eye The demonstration eye is designed for practicing operation of the CIRRUS photo. When required, the holder with the demonstration eye is inserted into the fastening pin holes for the paper pads (6, Fig. 4) on the head rest. By moving the unit longitudinally, an ametropia of ±5 D can be adjusted.
Optional accessories Printer WARNING - RISK OF ELECTRIC SHOCK The printer must be set up outside the patient environment (1.5 m from the patient's seat at the instrument), operated with a network isolator and plugged into a separate socket. The user may not touch the printer and patient simultaneously.
Optional accessories Installation of a network printer The CIRRUS photo supports only PostScript® network printers. These can be connected to the CIRRUS photo via Ethernet or via a printer server in an existing network, or directly (peer-to-peer). Keep the user manual for your printer or printer server at hand. The printer must be configured according to the instructions contained in the user manual for the printer or printer server.
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Optional accessories Printer outside the patient environment CIRRUS photo and printer are connected via a network Fig. 19 Variations for printer installation 000000-2121-813-GA-GB-050416...
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Optional accessories Peer-to-peer connection of printer with CIRRUS photo • Connect the network printer or printer server to the CIRRUS photo using a so-called crossover cable or a non-crossover cable with a crossover adapter. Select the length of the network cable such that the printer can be positioned outside the patient environment (at least 1.5 m from the patient to be examined).
Technical data Technical data Essential performance of the CIRRUS photo The essential performance features of the device are imaging and displaying measurements of the anterior and posterior eye segment or in case of error no imaging or displaying of information. Device data Rated voltage;...
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Technical data Imaging Fundus camera image capture Field angle 45° and 30° Ametropia compensation +35 D to -35 D continuous Filter Blue/IR cut filter (UV and IR protection) Fluorescein and ICG angiography filter Fundus autofluorescence filter Max. image sequence 1 image every 2 s Magnification 0.5x on image sensor (image diameter on sensor 7.4 mm), independent of focusing state...
The use of accessories, any converters or cables which are not specified in this user manual or have not been purchased as spare parts from Carl Zeiss Meditec can result in increased emissions or reduced immunity of the device. Relevant accessories, leads and converters: •...
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Electromagnetic compatibility The information below only applies for the accessories specified and supplied by Carl Zeiss Meditec for the device. Guidance and manufacturer’s declaration - electromagnetic emissions The CIRRUS photo is intended for use in the electromagnetic environment specified below. The customer or the user of the CIRRUS photo should assure that it is used in such an environment.
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Electromagnetic compatibility Guidance and manufacturer’s declaration - electromagnetic immunity The CIRRUS photo is intended for use in the electromagnetic environment specified below. The customer or the user of the CIRRUS photo should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
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Electromagnetic compatibility Guidance and manufacturer’s declaration - electromagnetic immunity The CIRRUS photo is intended for use in the electromagnetic environment specified below. The customer or the user of the CIRRUS photo should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance level...
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Electromagnetic compatibility Recommended separation distances between portable and mobile RF communications equipment and the CIRRUS photo The CIRRUS photo is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CIRRUS photo can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CIRRUS photo as recommended below, according to the maximum output power of the communications equipment.
Abbreviations/Glossary Abbreviations/Glossary Blue (capture mode) Diopters (unit of measurement for refractive power) DICOM Digital Imaging and Communications in Medicine (Open standard for the exchange of digital images and corresponding patient data in the medical sector) Deutsches Institut für Normung (German standards institution) Digital visual interface (interface for the digital transfer of video data) EMR system...
Figures Figures Fig. 1 Warning and information labels on the device ......11 Fig. 2 Basic design of the CIRRUS photo ..........18 Fig. 3 Controls of main unit, right hand view ........19 Fig. 4 Controls of main unit, left hand view .......... 20 Fig.
Index Index Abbreviations .................... 61 Accessories, optional ................. 48 Angiography ..................... 36 Care ......................39 Cleaning ....................39 Control ...................... 30 Control panel .................... 31 Daily use ....................27 Data backup ..................39, 45 Demonstration eye ..................49 Description of the device ................17 Device classification ..................
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Index Operation of the device ................29 Package check list ..................5 Paper pads ....................40 Performance specifications ................ 15 Printer installation ..................51 Safety inspections ..................46 Service life ....................16 Shutting down ..................35 Switch off ....................35 Switching on .....................
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Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 07745 Jena Germany Phone: +49 3641 220 333 Fax: +49 3641 220 112 000000-2121-813-GA-GB-050416 Email: info.meditec@zeiss.com CIRRUS photo Internet: www.zeiss.com/med Specifications subject to change...
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Contents Addendum to the documentation set Remote maintenance tool [000000-2121-813-AddGA01-GB-210915] 2121-813 000000- -Inhalt2-GB...
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Remote maintenance tool Addendum to the documentation set...
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Online remote maintenance tool Online remote maintenance tool The device is equipped with an online remote maintenance module, which enables you to contact Carl Zeiss Meditec Service for troubleshooting and remedy via the Internet. The online remote maintenance module offers two problem resolution options: •...
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Online remote maintenance tool Fig. 2 Login window for remote maintenance • Call the Carl Zeiss Meditec service team who will provide you with a 6-digit session number. • Enter the session number in the Session ID and click on Finish.
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In the event of problems, the user can create an archive with information and screenshots of the occurring problem, export them to an external net- work drive or USB flash drive and send them by e-mail to Carl Zeiss Meditec Service.
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The file ServicePackage.svp will now be found on the drive speci- fied in the last step. Send this file via e-mail to Carl Zeiss Meditec Service. Carl Zeiss Meditec Service will evaluate the file and issue instructions to solve the problem or arrange a service appointment with you.
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The user must alert the service technician from Carl Zeiss Meditec AG or a company authorized by them by telephone if there are other people in the room in which the instrument is located during a remote maintenance session.
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10. Except in cases of intent or gross negligence, Carl Zeiss Meditec AG accepts no liability – on any legal basis – for damages arising during fault diagnosis or maintenance in remote maintenance mode.
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Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 07745 Jena Germany Phone: +49 3641 220 333 Fax: +49 3641 220 112 000000-2121-813-AddGA01-GB-210915 Email: info.meditec@zeiss.com Remote maintenance tool Internet: www.zeiss.com/med Specifications subject to change...
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Contents MICROSOFT SOFTWARE LICENSE TERMS WINDOWS EMBEDDED STANDARD 7 [WINDOWS EMBEDDED STANDARD 7 GB, 21.06.2012] 2121-813 000000- -Inhalt3-GB...
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MICROSOFT SOFTWARE LICENSE TERMS WINDOWS EMBEDDED STANDARD 7 These license terms are an agreement between you and Carl Zeiss Meditec AG (CZM). Please read them. They apply to the software included on this device. The software also includes any separate media on which you received the software.
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• Internet Information Services, and • Internet Connection Sharing and Telephony Services. The ten connection limit applies to devices that access the software indirectly through “multiplexing” or other software or hardware that pools connections. You may use unlimited inbound connections at any time via TCP/IP. d.
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only in certain ways. For more information, see the software documentation or contact CZM. You may not: work around any technical limitations in the software; reverse engineer, decompile or disassemble the software; make more copies of the software than specified in this agreement; publish the software for others to copy;...
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Microsoft to revoke the software’s ability to use WMDRM to play or copy protected content. Revocation does not affect other content. When you download licenses for protected content, you agree that Microsoft may include a revocation list with the licenses. Content owners may require you to upgrade WMDRM to access their content.
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• Media Center Online Promotions. If you use Media Center features of the software to access Internet-based content or other Internet-based services, such services may obtain the following information from the software to enable you to receive, accept and use certain promotional offers: •...
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9. BACKUP COPY. You may make one backup copy of the software. You may use it only to reinstall the software on the device. 10. DOCUMENTATION. Any person that has valid access to your device or internal network may copy and use the documentation for your internal, reference purposes.
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This limitation applies to: anything related to the software, services, content (including code) on third party internet sites, or third party programs, and claims for breach of contract, breach of warranty, guarantee or condition, strict liability, negligence, or other tort to the extent permitted by applicable law. It also applies even if Microsoft should have been aware of the possibility of the damages.
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Permission to use, copy, modify, distribute, and sell this software and its documentation for any purpose is hereby granted without fee, provided that (i) the above copyright notices and this permission notice appear in all copies of the software and related documentation, and (ii) the names of Sam Leffler and Silicon Graphics may not be used in any advertising or publicity relating to the software without the specific, prior written permission of Sam Leffler and Silicon Graphics.
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this permission notice appear in all copies, and that any documentation, advertising materials, and other materials related to such distribution and use acknowledge that the software was developed in part by the University of Southern California, Information Sciences Institute. The name of the University may not be used to endorse or promote products derived from this software without specific prior written permission.
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RSA Data Security, Inc. makes no representations concerning either the merchantability of this software or the suitability of this software for any particular purpose. It is provided "as is" without express or implied warranty of any kind. These notices must be retained in any copies of any part of this documentation and/or software. Portions of this software are based in part on the work of OpenVision Technologies, Inc.
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Copyright 1989, 1990 by the Massachusetts Institute of Technology. All Rights Reserved. Export of this software from the United States of America may require a specific license from the United States Government. It is the responsibility of any person or organization contemplating export to obtain such a license before exporting.
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This product contains graphics filter software; this software is based in part on the work of the Independent JPEG Group. This product includes “True Verb” technology from KS Waves Ltd. Portions of this software are based in part on the work of SGS-Thomson Microelectronics, Inc. Because Microsoft has included the SGS-Thomson Microelectronics, Inc.
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NOT INFRINGE ANY THIRD PARTY PATENTS, COPYRIGHTS, TRADEMARKS OR OTHER RIGHTS. COPYRIGHT HOLDERS WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF ANY USE OF THE SOFTWARE OR DOCUMENTATION. The name and trademarks of copyright holders may NOT be used in advertising or publicity pertaining to the software without specific, written prior permission.
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