Zeiss CIRRUS photo 600 Manual Download

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Performance specifications

000000-2121-813-GA-GB-050416

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).

Modifications to the product or failure to follow the manufacturer’s
instructions may substantially reduce the expected service life and

significantly increase the risks associated with the use of this device.
It is the responsibility of the institution operating this product to follow the

manufacturer’s instructions and to decide on the risk/benefit ratio upon

expiration of the expected service life or maintenance and inspection

intervals specified by the manufacturer.

Summary of Contents for CIRRUS photo 600

Page 1: ...CIRRUS photo CIRRUS photo 600 and CIRRUS photo 800 Documentation set...

Page 2: ...a trademark misuse The weblinks are dynamic hyperlinks Before incorporating any links Carl Zeiss Meditec AG checks their content to ensure that it is not likely to result in civil or criminal liabilit...

Page 3: ...WS EMBEDDED STANDARD 7 GB 21 06 2012 Appendix CIRRUS photo 600 CIRRUS photo 800 Settings 000000 2121 813 AddGA02 GB 280815 CIRRUS photo 600 800 Internal fixation targets 000000 2121 813 AddGA03 GB 030...

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Page 5: ...000000 2121 813 Inhalt1 GB Contents User manual CIRRUS photo 600 and CIRRUS photo 800 000000 2121 813 GA GB 050416 1...

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Page 7: ...CIRRUS photo CIRRUS photo 600 and CIRRUS photo 800 User manual...

Page 8: ...000000 2121 813 GA GB 050416...

Page 9: ...le 9 Disposal of the product 10 External labels 11 Performance specifications 15 Functional description 15 Service life 16 Description of the device 17 Connection panel of main unit 21 Connection pane...

Page 10: ...39 Care and cleaning 39 Data backup 45 Data backup using FORUM Archive 45 Data backup via DICOM export import 45 CIRRUS photo backup function 45 Further notes on data backup 46 Inspection of electrica...

Page 11: ...d therefore ensure that you are thoroughly familiar with this user manual before setting up and using the CIRRUS photo the first time Please also observe the operating instructions for other device co...

Page 12: ...ormation in this user manual and on device labels WARNING Indicates a hazardous situation which may result in death or serious injury if the appropriate safety precautions are not heeded CAUTION Indic...

Page 13: ...o delivery package Documentation set Basic device consisting of Main unit OCT engine Power module with power isolation transformer Instrument table Table mounting for power module and OCT engine Exter...

Page 14: ...notes on classification are to be found in section Technical data page 54 and following This device complies with EC Directive 93 42 EEC MDD Device group overall system 2 in accordance with ISO 15004...

Page 15: ...It also includes a Retinal Nerve Fiber Layer RNFL Optic Nerve Head ONH and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer optic nerve head and...

Page 16: ...n the head chin rest Allow for serious restrictions in the use of the instrument for patient groups Patients with complete or partial coverage of the cornea caused by palpebral fissure which is closed...

Page 17: ...eir examination results Knowledge of the effects of incorrect or inaccurate readings on the therapy Possible consistency checks against other measurement results Practical experience in handling ophth...

Page 18: ...osal of the product within the EU In accordance with applicable EU guidelines and national regulations at the time at which the product was brought onto the market the product specified on the consign...

Page 19: ...Country specific information and labels 000000 2121 813 GA GB 050416 11 External labels Fig 1 Warning and information labels on the device...

Page 20: ...foreign bodies of 12 5 mm in diameter and larger no protection against penetration of water 2 CIRRUS photo 800 identification label REF Catalogue number part number SN Serial number CIRRUS photo 600 i...

Page 21: ...ied body 8 OCT engine type label 9 Sign with date of manufacture 10 Information label Disconnect device from the power supply before opening 11 Information label Observe user manual 12 Power supply un...

Page 22: ...e identification label P N Product number S N Serial number 14 24 V output information label 15 230 V output information label 16 Not applicable Not applicable 17 CIRRUS photo 800 main unit identifica...

Page 23: ...pupil is required for image series such as angiography Infrared diodes are used as a light source for setting up CIRRUS photo The working distance is set up using two working distance dots and the fu...

Page 24: ...Inspection of electrical safety page 46 Modifications to the product or failure to follow the manufacturer s instructions may substantially reduce the expected service life and significantly increase...

Page 25: ...he fundus using infrared LEDs for illumination of the fundus A Xenon flash lamp is used to capture fundus images The OCT engine provides all means to control obtain and reconstruct OCT scan data A sup...

Page 26: ...le 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 information 5 Instrume...

Page 27: ...ight 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 b...

Page 28: ...p 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...

Page 29: ...VI 5 Connection for external network 6 2x USB 3 0 ports 7 Connector for communication cable 8 2x USB 2 0 ports 9 Connector for data transfer cable 10 Power supply input 11 Socket for optical fiber 12...

Page 30: ...13 GA GB 050416 22 Connection panel of OCT engine 1 Connector for data transfer cable 2 Socket for optical fiber 3 Connector for communication cable 4 Connector for scanner control 5 Power supply inpu...

Page 31: ...e unit as a multiple socket is prohibited No components other than the system components described should be connected When connecting other system components than that described in this manual to the...

Page 32: ...ously 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 7 Power module front view 1 Po...

Page 33: ...364 7 710 or the applicable national regulations This includes the integration of a ground fault circuit interrupter GFCI To avert the risk of an electric shock this device may only be connected to a...

Page 34: ...re 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 R...

Page 35: ...entilation slits should not be covered or otherwise obstructed WARNING RISK OF ELECTRIC SHOCK Please ensure that the following operational requirements are met each time before using the instrument an...

Page 36: ...re switched on CAUTION PROPERTY DAMAGE To restart the system after it has been inadvertently switched off at the power switch 1 Fig 7 during operation or after a system crash switch the device back on...

Page 37: ...ZARDS The patient should not touch the instrument with his her hands In particular the device should not be used as a support or an aid when standing up CAUTION RISK OF FALSE DIAGNOSIS The use of the...

Page 38: ...o user interface is used in the same way as Microsoft Windows This includes working with a mouse using buttons dialogs and menus confirmation by double click etc The software uses only a few automatic...

Page 39: ...nd 4 Fig 10 Increment with Decrement with Attention mode 6 Fig 10 Fundus images Causes the internal fixation target to flash three times aiding the patient to locate it quickly OCT and combination mod...

Page 40: ...ation administrator rights required in order to prevent access to the instrument and data by unauthorized persons Assign the appropriate access rights to the persons authorized to use the instrument E...

Page 41: ...nt It contains sensitive parts which must remain in their original position in order to ensure precise measurements The tool should be handled carefully and should not be dropped A damaged test tool c...

Page 42: ...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...

Page 43: ...ice and report the problem to the ZEISS service Defective sensor for right left detection right left labeling may be incorrect Electric shock Penetration of substances Faults that cannot be remedied a...

Page 44: ...ome images of a patient s eye are generated The patient s eye is illuminated with light in different wavelengths which stimulates the injected solution fluorescein sodium F or indocyanine green ICG to...

Page 45: ...power cable not connected Connect cables to power supply No image on monitor Monitor power cable not connected Connect cables to power module 5 Fig 8 Monitor displays message Cable not connected Moni...

Page 46: ...416 38 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 ho...

Page 47: ...g alcohol Javel water iodine classification pursuant to Disinfectants and activity spectrum according to the Center for Disease Control and Prevention Atlanta USA CAUTION RISK OF FALSE DIAGNOSIS Use t...

Page 48: ...paper pads on the chin rest 5 Fig 4 of the headrest Re insert the two holding pins through the holes in the paper pads and into the holes provided in the headrest Tear off the top paper liner after ea...

Page 49: ...used by small drops of the patient s tear fluid sprayed on the front lens when blinking It is important to avoid serious contamination caused by the patient sneezing or touching the lens surface with...

Page 50: ...visible the lens surface must be moist cleaned see Removing severe dirt accumulation Removing severe dirt accumulation A typical cause of severe contamination is accidental contact between the front l...

Page 51: ...r smudges and streaks as described under Checking on the progress of cleaning in the following For fine cleaning apply the cleaning disc of the LensPen as described in Dust removal page 41 Checking on...

Page 52: ...lt 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 contact with the finger or nose An image...

Page 53: ...a saved in FORUM will be deleted from CIRRUS photo Data backup via DICOM export import If FORUM is not available a backup copy can be created via DICOM data export whereby data is archived on an exter...

Page 54: ...ictate otherwise the operator is advised to carry out an annual inspection in which the electrical safety is tested in accordance with IEC 62353 2014 When performing the inspection observe the followi...

Page 55: ...After successful measurement the device leakage current must be measured Preferably the differential current method should be used The device is in its operating state Press the measuring tip onto the...

Page 56: ...tors and network cables must be installed in accordance with Fig 18 A USB isolator cut off voltage at least 4 kV with USB cable must be used for data exchanged via external USB devices with separate p...

Page 57: ...es for the paper pads 6 Fig 4 on the head rest By moving the unit longitudinally an ametropia of 5 D can be adjusted USB flash drive The USB flash drive can be used for fast data transfer It is connec...

Page 58: ...used The printer is used for printing capture images It can be connected to the CIRRUS photo via the network as a network printer see Fig 18 or directly peer to peer see the following description 1 CI...

Page 59: ...twork 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 a...

Page 60: ...Optional accessories 000000 2121 813 GA GB 050416 52 Printer outside the patient environment CIRRUS photo and printer are connected via a network Fig 19 Variations for printer installation...

Page 61: ...l provided with the device as follows IP address 192 168 100 6 Subnet mask 255 255 255 0 Connection of printer via an existing network The administrator responsible for your local network must first o...

Page 62: ...ction class I according to IEC AAMI ANSI 60601 1 2005 Application class device type B according to IEC AAMI ANSI 60601 1 2005 Observation illumination IR LEDs light emitting diodes 830 nm Fuses 2 x T6...

Page 63: ...n flash bulb HD OCT imaging Axial resolution 5 m in tissue Transversal resolution 15 m in tissue Scan rate 27 000 A scans per seconds A scan depth 2 0 mm in tissue 1024 pixels Radiation source Superlu...

Page 64: ...radio transmission components in the direct vicinity of the CIRRUS photo Monitor the CIRRUS photo during use to ensure that it is being used as specified in the particular environment Users should not...

Page 65: ...t Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The CIRRUS photo uses RF energy only for its internal function Therefore its RF emissions are very low an...

Page 66: ...1000 4 5 1 kV line s to line s 2 kV line s to ground 1 kV line s to line s 2 kV line s to ground Mains power quality should be that of typical commercial or hospital environments Voltage dips short in...

Page 67: ...m Field strengths from fixed RF transmittersa should be less than the compliance levelb in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol No...

Page 68: ...output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 d 1 2 d 2 3 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0...

Page 69: ...ement system EN European standard FA Fluorescein angiography capture mode FAF Fundus autofluorescence capture mode Fig Figure FTP File transfer protocol network protocol for data transfer G Green capt...

Page 70: ...CT engine 22 Fig 7 Power module front view 24 Fig 8 Power module rear view 24 Fig 9 Patient dialog 28 Fig 10 Control panel on instrument base 31 Fig 11 Installation of the test tool 34 Fig 12 Replacin...

Page 71: ...tion eye 49 Description of the device 17 Device classification 6 Disposal 10 E Electrical connection 21 Electromagnetic compatibility 56 F Fault remedy 37 Figures 62 Flashing diode replacing 38 Fluore...

Page 72: ...29 P Package check list 5 Paper pads 40 Performance specifications 15 Printer installation 51 S Safety inspections 46 Service life 16 Shutting down 35 Switch off 35 Switching on 28 Symbols 4 T Technic...

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Page 74: ...AG Goeschwitzer Str 51 52 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www zeiss com med 000000 2121 813 GA GB 050416 CIRRUS photo Specifications...

Page 75: ...000000 2121 813 Inhalt2 GB Contents Addendum to the documentation set Remote maintenance tool 000000 2121 813 AddGA01 GB 210915 2...

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Page 77: ...Remote maintenance tool Addendum to the documentation set...

Page 78: ...000000 2121 813 AddGA01 GB 210915...

Page 79: ...user interface is visible to a service technician who is able to operate or configure the software directly using the remote control function To use the remote maintenance tool proceed as follows Ens...

Page 80: ...Enter the session number in the Session ID and click on Finish Fig 3 Dialog for confirmation of screen content transfer Confirm the transfer in the netviewer dialog by clicking on Yes A connection wi...

Page 81: ...the control window will terminate the remote maintenance session Offline remote maintenance tool If the device does not have a network connection the offline remote maintenance module can be used In t...

Page 82: ...and click on the Screenshot button to generate a screenshot of your screen Once you have created all the necessary screenshots click on Continue in the offline remote maintenance dialog box see Fig 5...

Page 83: ...nsibility to take all necessary measures to ensure that confidential data is protected during the remote mainte nance session and that all legal regulations are adhered to 4 In remote control mode a s...

Page 84: ...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 11...

Page 85: ......

Page 86: ...chwitzer Str 51 52 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www zeiss com med 000000 2121 813 AddGA01 GB 210915 Remote maintenance tool Specif...

Page 87: ...000000 2121 813 Inhalt3 GB Contents MICROSOFT SOFTWARE LICENSE TERMS WINDOWS EMBEDDED STANDARD 7 WINDOWS EMBEDDED STANDARD 7 GB 21 06 2012 3...

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Page 89: ...e rights below 1 USE RIGHTS Use The software license is permanently assigned to the device with which you acquired the software You may use the software on the device 2 ADDITIONAL LICENSING REQUIREMEN...

Page 90: ...ages and sounds While the software is running you may use but not share its icons images sounds and media 3 VHD BOOT Additional copies of the software created using the software s Virtual Hard Disk fu...

Page 91: ...such as your Internet protocol address the type of operating system and browser the name and version of the software you are using and the language code of the device where you installed the software...

Page 92: ...890830 Network Awareness This feature determines whether a system is connected to a network by either passive monitoring of network traffic or active DNS or HTTP queries The query only transfers stan...

Page 93: ...e required from time to time and downloaded and installed without further notice to you Without limiting any other disclaimer in these license terms or any license terms accompanying a Windows Update...

Page 94: ...ABOVE STANDARDS VIDEO STANDARDS AND OR ii DECODE VIDEO THAT WAS ENCODED BY A CONSUMER ENGAGED IN A PERSONAL AND NON COMMERCIAL ACTIVITY OR WAS OBTAINED FROM A VIDEO PROVIDER LICENSED TO PROVIDE VIDEO...

Page 95: ...to claims for breach of it regardless of conflict of laws principles The laws of the state where you live govern all other claims including claims under state consumer protection laws unfair competiti...

Page 96: ...Because Microsoft has included the Highground Systems software in this product Microsoft is required to include the following text that accompanied such software Copyright 1996 1999 Highground Systems...

Page 97: ...supporting documentation Permission is also given to modify the software to any extend under the condition that in the modified software the prefix GB_ is changed to something else and the name direct...

Page 98: ...CTION OF CONTRACT NEGLIGENCE OR OTHER TORTIOUS ACTION ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE Portions of this software are based in part on the work of Regents of...

Page 99: ...ided that the above copyright notice appear in all copies and that both that copyright notice and this permission notice appear in supporting documentation and that the name of M I T not be used in ad...

Page 100: ...that a the above copyright notice s and this permission notice appear with all copies of the Data Files or Software b both the above copyright notice s and this permission notice appear in associated...

Page 101: ...IN ANY WAY OUT OF THE USE OF THIS SOFTWARE EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE Portions of this software are based in part on the work of W3C Because Microsoft has included the W3C softw...

Page 102: ...DEALING USAGE OR TRADE PRACTICE Sun RPC is provided with no support and without any obligation on the part of Sun Microsystems Inc to assist in its use correction modification or enhancement SUN MICRO...

Page 103: ...d metadata and is available at no cost from the Optical Storage Technology Association More information about the MPV specification can be found at www osta org mpv Permission Notice Permission is her...

Page 104: ...WINDOWS EMBEDDED STANDARD 7 GB 21 06 2012 16...

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Page 106: ...AG Goeschwitzer Str 51 52 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www zeiss com med CIRRUS photo Specifications subject to change 000000 2121...

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