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Electromagnetic compatibility

000000-2121-813-GA-GB-050416

57

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.

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 and are not likely to cause any
interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The CIRRUS photo is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions
IEC 61000-3-3

Complies

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Содержание CIRRUS photo 600

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

Страница 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...

Страница 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...

Страница 4: ......

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

Страница 6: ......

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 73: ......

Страница 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...

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

Страница 76: ......

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 85: ......

Страница 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...

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

Страница 88: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 105: ......

Страница 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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