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Documentation set

11 Technical specifications

VISULAS green

11.1 Risk-relevant performance features of clinical functions

000000-2096-101-DokS-GB-181218

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11 Technical specifications

11.1 Risk-relevant performance features of clinical

functions

• No undesired laser shot and no parameter change in "Treat"

step (READY mode)

• No power deviation of more than 20 % without warning

message and no power deviation of more than 50 % without
error message in active shooting mode

• Accurate positioning of laser beam

• 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
the device without the manufacturer’s authorization.

11.2.1 Guidelines with which the system is compliant

The system complies with EU Medical Device Directive 93/42/EEC:
Class II b

It is marked with

11.2.2 The device fulfills the requirements of the following

standards

• IEC 60601-2-22

11.2.3 System classification

The system is classified as follows:

Device class according to MDD:

IIb

UMDNS No.

17-446 (VISULAS green)

11.2.4 RoHS Conformity

The product is compliant to RoHS according to directive
2011/65/EU.

Содержание VISULAS green

Страница 1: ...VISULAS green Documentation set...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

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

Страница 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...

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

Страница 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...

Страница 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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