Zeiss VISULAS green Manual Download Page 25

Page: 25 / 116

Documentation set

3 Description of the device

VISULAS green

3.2 Markings on the system

000000-2096-101-DokS-GB-181218

25 / 116

Symbol

Name

"Laser aperture" warning label

Standard / TouchControl foot switch

Symbol

Name

Standard

TouchControl

Type label

Manufacturer

Date of manufacture

Applied part type B

IPX8

Ingress protection rating (protection
against continuous immersion in water)

EU conformity symbol and identification
number of notified body

Disposal advice for EU

Catalog/part number

Serial number

Summary of Contents for VISULAS green

Page 1: ...VISULAS green Documentation set...

Page 2: ...Spotview InsightViewTM and TouchControlTM are trademarks or registered trademarks of Carl Zeiss Meditec AG or other members of the ZEISS Group in Germany and or other countries All other trademarks m...

Page 3: ...e responsible organization 12 2 3 1 Notification to manufacturers and authorities 13 2 4 Measures and duties of the operator 14 2 5 Risk from incoherent optical radiation 15 2 6 Hazard due to coherent...

Page 4: ...the foot of the instrument table 45 4 4 Moving the instrument table with the devices 46 5 Daily startup 47 5 1 Preparation safety 47 5 2 Switching on 47 6 Operation 49 6 1 Operation safety 49 6 2 Ope...

Page 5: ...lamp optional 90 10 Troubleshooting 93 10 1 Faults with messages 93 10 2 Faults no messages 94 10 3 Service information 94 11 Technical specifications 95 11 1 Risk relevant performance features of cli...

Page 6: ...reen 6 116 000000 2096 101 DokS GB 181218 12 2 Laser endoprobes 105 12 3 Connect the door contact isolator to the laser console 107 12 4 Physician s safety filter 107 13 Disposal of the sytem 109 14 R...

Page 7: ...They are a guide for safe operation and specify the measures for maintenance and repair of the system The correct operation of the system is vital for safe and successful operation u Read these instr...

Page 8: ...avoided The warning message names the possible consequences u This is a measure with which hazards can be prevented CAUTION This is warning information about hazards that can cause injuries if not avo...

Page 9: ...andards and occupational safety and accident prevention regulations The country specific laser protection requirements must be adhered to 2 2 1 Intended use The VISULAS green is intended for use in ph...

Page 10: ...lt in vascular proliferation due to retinal ischemia e g proliferative diabetic retinopathy vascular occlusions Macular edema e g diabetic macular edema Chorioretinal neovascularization Retinal forame...

Page 11: ...us strands Clouding of the lens Notes u Always use a suitable contact lens for retinal photocoagulation u Avoid laser treatment if the patient underwent fluorescence angiography on the same day prior...

Page 12: ...age and provide information on this to all operating personnel see Section Notification to manufacturers and authorities 13 u Provide the required protective equipment u Regularly check compliance wit...

Page 13: ...cantly increase the risks associated with the use of this system and are thus not permitted Accessories and additional equipment u If you want to connect accessories or additional equipment to the sys...

Page 14: ...e instructions regarding electromagnetic compati bility EMC u Set the system up so that the power cable can be disconnected from the power supply quickly and without any supplementary means u Connect...

Page 15: ...sport the system over long distances e g move return for repair etc only in original packaging or special return packaging u Contact your dealer or ZEISS Service 2 5 Risk from incoherent optical radia...

Page 16: ...iming beam off when the system is not in use Because the aiming beam follows the same optical path through the beam delivery system as the therapy beam it represents a good method for checking that th...

Page 17: ...e patient and appropriately trained personnel may remain within the laser hazard area These persons must wear suitable laser safety goggles when the laser is in operation Persons working in the laser...

Page 18: ...cted from the main menu Never start treatment if a different applicator is shown in the display to the one required or if no physician s safety filter is fitted Do not fire the laser beam if the tip o...

Page 19: ...hich do not easily catch fire A fire extinguisher should be kept in the vicinity of the system Check the integrity of all lenses and glass surfaces before each use Severe contamination may result in u...

Page 20: ...Empty page for your notes...

Page 21: ...VISULAS green version with LSL green classic laser slit lamp This version cannot be upgraded with the VISULAS VITE 2 0 license VISULAS green laser console with control panel LSL green classic laser s...

Page 22: ...ISULAS green version with VISULINK 532 U VISULAS green VISULINK 532 U 2 0 m Slit lamp adapter Standard foot switch 1 6 m Armrest height adjustable Power supply cable 2 5 m Documentation set 3 2 Markin...

Page 23: ...5mm in diameter and larger no protection against penetration of water CE marking label and disposal advice for EU EU conformity symbol and identification number of notified body Disposal advice for E...

Page 24: ...mber LSL green comfort classic laser slit lamp Symbol Name comfort classic Type label Manufacturer Date of manufacture Applied part type B IP20 Ingress protection rating of housing protected against s...

Page 25: ...re warning label Standard TouchControl foot switch Symbol Name Standard TouchControl Type label Manufacturer Date of manufacture Applied part type B IPX8 Ingress protection rating protection against c...

Page 26: ...AS green laser indirect ophthalmoscope VISULAS green laser console with control panel and foot switch LSL green laser slit lamp Instrument table with mounting for laser console optional Laser endoprob...

Page 27: ...m structure 000000 2096 101 DokS GB 181218 27 116 3 3 2 System overview 1 2 3 4 5 6 Figure 2 System overview version shown is the VISULAS green comfort 1 Laser slit lamp 2 Control panel 3 Instrument t...

Page 28: ...stable eye cups 2 Binocular tube 3 Microscope stand with fixed physician s safety filter 4 Prism head illumination and laser exit aperture 5 Forehead support applied part 6 Markings for setting the op...

Page 29: ...es that the area of the fundus which is to be coagulated is always illuminated even in the peripheral fundus This means of combining illumination and laser beams is particu larly advantageous for smal...

Page 30: ...stop switch is enabled 2 Key switch Switches the system on 3 LSL ENDO laser console with dual port LSL ENDO LIO laser console with single port Optical fiber connection for Laser slit lamp Laser endopr...

Page 31: ...em can be controlled by turning pressing the rotary knob button As long as no parameters have been activated the knob can be rotated to switch between the parameters Pressing the button on the rotary...

Page 32: ...h time the laser is triggered this will be confirmed by a short acoustic signal This acoustic signal can be switched on and off in the Configure work step 3 4 2 1 Changing parameter values on the touc...

Page 33: ...ments on the LSL green comfort laser slit lamp Item Icon Name Explanation 1 Height adjustment for chin rest The optimal eye level for the patient can be achieved by adjusting the height of the chin re...

Page 34: ...0 TouchControl LSL Center Switch Rocker for selection and adjustment of parameters see Section LSL InsightView Display and TouchControl LSL Center Switch 34 11 Fast action base lock Lever tilted towar...

Page 35: ...e left Switch to the next parameter anti clockwise Value of the activated parameter is reduced Press towards the right Switch to the next parameter clockwise Value of the activated parameter is increa...

Page 36: ...1 2 3 4 5 6 9 10 11 12 13 7 8 Figure 8 Control elements on the LSL green classic laser slit lamp Item Icon Name Explanation 1 Height adjustment for chin rest The optimal eye level for the patient can...

Page 37: ...ase Locking screw for securing the instrument base at the desired position 7 Laser slit lamp connecting cable The plug on this cable is inserted into the fiber optic port for LSL on the laser console...

Page 38: ...ndard foot switch Item Name Explanation 1 Protective cover 2 Trigger Depending on the setting pressing the trigger will emit one or more laser pulses The desired parameters must have been set previous...

Page 39: ...parameter value 2 Protective cover 3 Trigger Depending on the setting pressing the trigger will emit one or more laser pulses The desired parameters must have been previously set with the parameter ch...

Page 40: ...ration of laser beam with 532 nm 6 111 3 5 1 Safety systems Safety system Effect Plug type connector for remote controlled locking The system incorporates a plug type connector for remote controlled l...

Page 41: ...ed at any time by releasing the manual foot trigger Laser stop switch The laser stop switch interrupts the laser beam in order to avoid endangering persons The laser stop switch is struc turally indep...

Page 42: ...Empty page for your notes...

Page 43: ...ospital Grade design for specific countries e g USA Canada For cables 2 5 m the cross section must be increased to 1 5 mm WARNING Electrical hazard from connecting additional devices When connecting o...

Page 44: ...age to the fiber optic cable The functioning of the fiber optic cable may be impaired by contamination and damage u Do no touch the end of the fiber optic cable with your fingers u Protect the end of...

Page 45: ...two rear screws The installation is performed as described below The feet of the IT 760 i IT 1060 i instrument tables have three five drilled holes to which the foot switch can be secured by means of...

Page 46: ...e the upper plate until the assembly hole is aligned with the two holes 4 Screw the adapter plate onto the table foot using the screws supplied 5 Screw the foot switch onto the adapter plate using the...

Page 47: ...The following inspec tions must be carried out each working day prior to use Action u Visual inspection of device power cable and accessories to ensure that they are present and intact If parts are mi...

Page 48: ...Empty page for your notes...

Page 49: ...o laser radiation Triggering the laser by unauthorized persons may result in injury u Remove the key from the key switch after each use WARNING Hazard due to laser radiation Incorrect application of t...

Page 50: ...at no parts of the body fingers hands or objects are trapped beneath the devices when lowering the devices 6 2 Operation with laser slit lamp 6 2 1 Adjusting the slit lamp and eyepieces Action 1 Make...

Page 51: ...t the best overall view if a magnification of 12x is selected on the slit lamp 6 2 3 Laser treatment with laser slit lamp 6 2 3 1 Positioning and focusing the laser spot WARNING Hazard due to laser ra...

Page 52: ...u Release the trigger to instantaneously stop the laser therapy beam Multi spot mode VITE multi spot option u Switch on the laser therapy beam by pressing the manual trigger on the joystick u Hold do...

Page 53: ...he control panel CAUTION Hazard due to laser radiation The physician s eyes may be harmed by the laser beam u Before carrying out treatment check that the physician s safety filter is installed in the...

Page 54: ...e navigation bar select the Prepare work step if no laser treatment is to be performed After treatment switch off the system at the laser console using the key switch and remove the key 6 4 Switching...

Page 55: ...volume of acoustic signals on the loudspeaker of the control panel Settings Open the Settings dialog window 2 Dialog area Configure the parameters of the current treatment 3 Navigation bar Navigate be...

Page 56: ...ext box Figure 15 On screen keyboard 7 3 Configure work step In the first Configure work step select a user and specify the basic pre settings therapy applicator treatment technique trigger for the im...

Page 57: ...veral treatment techniques have already been factory set The treatment parameters can be adjusted in the settings and further treatment techniques defined 5 Trigger Select the control element by which...

Page 58: ...e two arrow keys or with a circular motion on the displayed arc 2 Contact lens Select a contact lens from the drop down list Some contact lenses have already been factory set Further contact lenses ma...

Page 59: ...ence of the laser beam at the point to be treated Energy density is a measure of thera peutic effect on the eye 10 Laser pulse counter Displays the number of triggered laser pulses 11 Laser spot size...

Page 60: ...essage displayed 7 1 2 3 4 5 6 9 10 11 12 13 14 8 Figure 18 Prepare work step in Multi spot mode Item Icon Name Explanation 1 Power Adjust laser power The laser power can be adjusted using the rotary...

Page 61: ...rgy density laser fluence of the laser beam at the point to be treated Energy density is a measure of thera peutic effect on the eye 11 Laser pulse counter Displays the number of triggered laser pulse...

Page 62: ...equences are triggered in succession with lateral shift 3 Square shaped spot sequence A square shaped spot sequence 2 x 2 or 3 x 3 with a pulse length of 10 ms also 4 x 4 is triggered 4 Circle segment...

Page 63: ...s displayed The laser is active Once all parameters have been set the laser beam can be released with the manual or foot trigger 7 5 1 Single spot mode 1 2 3 4 5 6 7 13 12 11 9 8 10 Figure 20 Treat wo...

Page 64: ...keys or with a circular motion on the displayed arc If the pause is shortened to below the minimum or the button is activated only a single laser pulse with the pre set duration will be emitted 7 Aimi...

Page 65: ...cted 13 Applicator Displays the selected applicator Slit lamp has been selected as the applicator LIO VISULAS green laser indirect ophthalmoscope has been selected as the applicator Laser endoprobe ha...

Page 66: ...er power can be adjusted using the rotary knob tapping the two arrow keys or with a circular motion on the displayed arc 2 Contact lens Select a contact lens using the drop down list Some contact lens...

Page 67: ...herapy and contact lens have been selected the laser spot size on the retina is displayed marked with Retina If a glaucoma therapy and contact lens have been selected the laser spot size at the point...

Page 68: ...ep 68 116 000000 2096 101 DokS GB 181218 If you have the VISULAS Treatment Report license you can export the treatment data in the FORUM data management system from FORUM Vs 4 2 in order to generate s...

Page 69: ...of the user interface 1 5 4 3 2 6 Figure 23 Settings menu Item Icon Name Explanation 1 General Access and adjust the settings on the user interface 2 Treatments Access and adjust treatment profiles 3...

Page 70: ...user interface such as language or appearance can be adjusted in this window 1 2 Figure 24 General dialog area Item Icon Name Explanation 1 Language Select a user interface language using the drop do...

Page 71: ...user profiles and become available when the respective user is selected 1 2 3 Figure 25 Treatments dialog area Item Icon Name Explanation 1 User list Edit the data of the selected user 2 Select user S...

Page 72: ...er management This window is used to manage users Profiles may be added edited or deleted 1 2 3 4 Figure 26 Overview of current users Item Icon Name Explanation 1 Delete Delete selected user The actio...

Page 73: ...og window Item Icon Name Explanation 1 Input area Enter user data 2 Cancel Close the dialog window without saving 3 Save Save and close dialog window 7 7 2 2 Retina therapy 1 2 3 Figure 28 Select the...

Page 74: ...6 7 8 9 1 Figure 29 Overview of currently available single spot treatments Item Icon Name Explanation 1 Name Name of the treatment 2 Power Laser power 3 Pulse Duration of a laser pulse 4 Pause Interva...

Page 75: ...log window for editing adding a treatment Item Icon Name Explanation 1 Name Name of the treatment 2 Power Adjust laser power 3 Pulse Set pulse length 4 Pause Set the interval between two laser pulses...

Page 76: ...tions The user may add edit or delete treatments 1 2 3 4 5 6 7 8 9 10 11 Figure 31 Overview of currently available multi spot treatments Item Icon Name Explanation 1 Name Name of the treatment 2 Power...

Page 77: ...w 9 Add Add treatment 10 Edit Edit the selected treatment 11 Delete Delete the selected treatment The action must be confirmed in the following dialog window Add or edit treatment 1 2 3 4 5 6 7 Figure...

Page 78: ...e spot mode The parameters for Single spot 74 treatment can be adjusted analogous to the retina therapy 7 7 3 Contact lenses Contact lens data can be managed in this window Contact lenses may be added...

Page 79: ...igure 34 Dialog window for adding or editing a contact lens Item Icon Name Explanation 1 Name Enter or edit the name of a contact lens 2 Magnification Set magnification level using the and buttons 3 U...

Page 80: ...indow is used to view information on the product version and to activate deactivate the DEMO mode 1 2 3 4 Figure 35 System dialog area Item Icon Name Explanation 1 Product Display of the product name...

Page 81: ...O mode 1 2 3 Figure 36 Details dialog window Item Icon Name Explanation 1 Information area Displays details of the product version 2 Close Close the window 3 DEMO Activate deactivate DEMO mode The act...

Page 82: ...files The Log file export button opens a browser window in which the export directory can be selected and the export of log files is confirmed 2 Export Open Source licenses The License export button...

Page 83: ...amage due to improper cleaning and disinfection Some cleaning agents and disinfectants may have an adverse effect on plastic components Damage caused by such disinfectants is not covered by our warran...

Page 84: ...t and chinrest should be disinfected before each examination These parts are not removable We recommend wipe disinfection since the optical components could be adversely affected by spraying of disinf...

Page 85: ...ied out on your device serviced by by ZEISS Service or have an electrical safety inspection according to IEC 62353 performed by a qualified technician annually When performing the inspection observe t...

Page 86: ...nance Documentation set VISULAS green 9 1 Testing electrical safety 86 116 000000 2096 101 DokS GB 181218 Figure 38 Measurement points on the laser console Figure 39 Measurement points on the laser sl...

Page 87: ...iquid on the system which suggest the penetration of liquid measure the insulation resistance with a test voltage of 500 V The measured value may not be less than 2 M 4 After successful measurement th...

Page 88: ...es testing both the electrical and laser safety Regular calibration of the laser system is not required by the user u The safety features and equipment may only be inspected by persons authorized to d...

Page 89: ...mp holder 3 Remove the lamp socket and replace the defective halogen bulb Do not touch the bulb with bare fingers 4 Re insert the lamp socket Ensure that the lamp socket is correctly aligned with the...

Page 90: ...ment 2 Fuse 3 Fuse carrier Action 1 Remove the fuse carrier with fuse by pressing gently on the snap in clip 2 Replace the defective fuse 3 Re insert the fuse carrier with fuse Ensure that the fuse ca...

Page 91: ...placing the light emitting diode LED of the fixation lamp optional 000000 2096 101 DokS GB 181218 91 116 1 2 Figure 43 Replacing the LED 1 Red flashing LED 2 LED socket Action 1 Unscrew the defective...

Page 92: ...Empty page for your notes...

Page 93: ...r stop switch is locked u Unlock the laser stop switch Connect error of physician s safety filter u Check that the slit lamp and the OPMI surgical microscope ENDO physician s safety filter are correct...

Page 94: ...cted Which type of physician s safety filter are you using Safety question to check that the physician s safety filter is fitted in the surgical microscope u With a fixed physician s safety filter sel...

Page 95: ...Possibility to stop laser emission in hazardous situations Protective means to limit laser radiation in viewing optics 11 2 Compliance This declaration shall be rendered invalid if changes are made to...

Page 96: ...able from 10 to 6000 ms Aiming beam Diode 620 nm to 650 nm max 1 mW at the cornea Laser class of aiming beam Stays within the class 2 limit in accor dance with IEC 60825 1 Rated voltage frequency 100...

Page 97: ...used Laser beam delivery Interlaced with slit illumination system Illumination 12 V 30 W brightness continuously adjustable Slit adjustment Slit width Slit height Slit rotation Continuous 0 mm to 14...

Page 98: ...ity the VISULAS green is intended for use in the professional medical work environment The VISULAS green is neither intended to be used in private healthcare e g in private nursing and retirement home...

Page 99: ...VISULAS green including cables specified by the manufacturer Otherwise a deterioration of the performance of the VISULAS green is to be anticipated CAUTION Hazard from electromagnetic radiation The u...

Page 100: ...ate the VISULAS green but there could be increased emissions and or decreased immunity 11 6 3 Guidelines and manufacturer s electromagnetic compatibility declaration The following guideline applies on...

Page 101: ...s 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to ground 1 kV line s to line s 2...

Page 102: ...14 3 VRMS 150 kHz to 80 MHz 3 V 6 VRMS ISM bandsa 6 V Radiated HF IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 3 V m Radiated HF disturbances by near fields of wireless communication according to IEC 61000 4...

Page 103: ...2 adapter for Zeiss SL 115 Classic 532 adapter for Zeiss 20 SL 30 SL 532 adapter for Haag Streit 900 BM BQ Mounting base with screw for Haag Streit 900 BM Mounting pivot for Haag Streit 900 BQ 900 BP...

Page 104: ...ns OG3MA Ritch trabeculoplasty contact lens ORTA Laser endoprobes Sterile endoprobes 20 gauge straight 5 pcs Sterile endoprobes 20 gauge angled 5 pcs Sterile endoprobes 23 gauge straight 5 pcs Sterile...

Page 105: ...ent table it is essential to attach the foot extension see instrument table user manual to the instrument table 12 2 Laser endoprobes CAUTION Hazard due to laser radiation Optical fiber fatigue as a r...

Page 106: ...standard SMA socket 5 4 3 2 1 Figure 44 Laser endoprobe Example 1 Protective cap 2 Handpiece applied part 3 Optical fiber 3 m 4 Protective cap 5 SMA connection Connection of the laser endoprobe to the...

Page 107: ...ith a 3 5 mm jack plug mono to the output socket of the door contact isolator The contact must be operated in floating mode potential free NOTE The connection must be installed with strain relief to p...

Page 108: ...tending physician s eyes when looking through the binocular tube of the operating microscope If an assistant s scope is connected the physician s safety filter must be mounted upstream of the beam spl...

Page 109: ...h national regulations In accordance with applicable EU guidelines and national regula tions at the time at which the system was brought onto the market the product specified on the consignment note i...

Page 110: ...Empty page for your notes...

Page 111: ...s and complications of laser treatment in diabetic retinal disease In Seminars in ophthalmology 29 5 6 S 290 300 4 Fong Donald S Girach Aniz Boney April 2007 Visual side effects of successful scatter...

Page 112: ...Empty page for your notes...

Page 113: ...tical system ENDO Laser endoprobe IEC International Electrotechnical Commission LED LED is a light emitting diode LIO LIO Laser Indirect Ophthalmoscope is an indirect laser ophthalmoscope LSL Laser sl...

Page 114: ...Empty page for your notes...

Page 115: ...ety 14 85 Electromagnetic compatibility 98 F Faults With messages 93 Without messages 94 Fixation lamp 91 Foot switch Standard 38 TouchControl 39 I Instrument table 105 Intended use 9 K Key switch 30...

Page 116: ...Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Internet www zeiss com med E Mail info meditec zeiss com 000000 2096 101 DokS GB 181218...

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