Zeiss VISULAS YAG III User Manual Download

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Abbreviations/Glossary

000000-1272-175-GA-GB-060613

112

Abbreviations/Glossary

CISPR

Comité international special sur les perturbations
radioelectrique
(Special international committee on radio interference)

Diopter

DIN

Deutsches Institut für Normung
(German Institute for Standardization)

EMC

Electromagnetic compatibility

European Standard

Fig.

Figure

IEC

International Electrotechnical Commission

LSL

Laser split lamp

MPG

Medizinproduktegesetz
(German Medical Products Act)

NOHD

Nominal Ocular Hazard Distance
(safety distance from laser source)

Personal computer

Radio frequency

UMDNS

Universal Medical Device Nomenclature System

YAG

Yttrium aluminium garnet

Summary of Contents for VISULAS YAG III

Page 1: ...VISULAS YAG III Documentation set...

Page 2: ...ncorporating any links Carl Zeiss Meditec AG checks their content to ensure that it is not likely to result in civil or criminal liability It does not however continuously check for any changes which...

Page 3: ...SULAS YAG III 000000 1272 175 GA GB 060613 Appendix VISULAS YAG III stand alone operation Quick instructions 000000 1272 175 KurzGA01 GB 070513 VISULAS YAG III combination mode Quick instructions 0000...

Page 4: ......

Page 5: ...VISULAS YAG III User manual...

Page 6: ...000000 1272 175 GA GB 060613...

Page 7: ...nd safety instructions 16 General notes 16 Safety officer 17 Laser safety goggles 18 Patient safety 19 Explosion and fire hazards 19 Dangers caused by direct irradiation and reflection 20 Performance...

Page 8: ...i and VISULAS Trion Combi 53 Data display in the ACCENTO eyepiece 54 ACCENTO foot switch 55 Daily use 56 Switching on 56 Function test 57 Operation of the device 58 Laser treatment using VISULAS YAG I...

Page 9: ...VISULAS Trion Combi 92 Replacing the fuses 94 Replacing the fuse on the VISULAS YAG III laser console 94 Replacing the halogen bulb in the laser slit lamp 95 Maintenance and care 97 Care and cleaning...

Page 10: ...d therefore ensure that you are thoroughly familiar with this user manual before setting up and using the VISULAS YAG III the first time The user manuals and other documentation enclosed with the VISU...

Page 11: ...ation in this user manual and on instrument labels WARNING Indicates a hazardous situation which may result in fatal or serious bodily injury if the appropriate safety precautions are not heeded CAUTI...

Page 12: ...components VISULAS YAG III laser console LSL YAG III laser slit lamp Straight binocular tube f 140 mm 2 eyepieces 10x Head restrainer for VISULAS laser Armrest height adjustable Dust cover Fixation la...

Page 13: ...to be found in section Technical data page 104 The device VISULAS YAG III complies with EU Medical Device Directive 93 42 EEC and its national implementation in the form of the German Medical Product...

Page 14: ...the VISULAS Trion user manual must be observed The user is liable for any use of the device other than intended Side effects contraindications The VISULAS YAG III should not be used in cases of retin...

Page 15: ...adhere to the national qualification guidelines applicable in your country The VISULAS YAG III may only be operated by physicians who have adequate knowledge of the medical application of the instrum...

Page 16: ...isposal 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 cons...

Page 17: ...Country specific information and labels 000000 1272 175 GA GB 060613 11 Labels Fig 1 Warning and information labels on the VISULAS YAG III...

Page 18: ...cted against solid foreign bodies of 12 5mm in diameter and larger no protection against penetration of water 2 Identification label VISULAS YAG III REF Catalogue number part number SN Serial number 3...

Page 19: ...e specifications VISULAS YAG III 10 LSL YAG III type label LSL YAG III Combi type label LSL Trion Combi type label Manufacturer Date of manufacture Application parts type B conforming to IEC 60601 1 C...

Page 20: ...abel LSL YAG III Combi Identification label LSL Trion Combi 12 Date of manufacture 13 Laser class 4 warning label 14 Laser exit aperture warning label LSL YAG III LSL YAG III Combi LSL Trion Combi 15...

Page 21: ...switch 1 2 m ACCENTO foot switch 5 m Manufacturer Date of manufacture REF Catalogue number part number SN Serial number CE CE label 0297 Identification number of notified body IPX8 Housing protection...

Page 22: ...issue to be treated Never trigger the laser if the aiming beam is not clearly visible in the target area Deactivate the treatment beam and always switch the aiming beam off before changing the applica...

Page 23: ...responsibilities of the safety officer who is appointed in writing by the customer or the institution operating the laser include Implementation of safety measures Instruction of all persons working...

Page 24: ...lit lamp as described in the user manual in conjunction with VISULINK 532 U or the LIO Trion 532s laser indirect ophthalmoscope The institution operating the device is responsible for providing proper...

Page 25: ...t lamp the correct applicator must be selected 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 fitt...

Page 26: ...tly avoid irradiation of the eye or skin by direct or scattered radiation Metallic and similar surfaces reflect laser beams All persons present in the laser hazard area must therefore wear laser safet...

Page 27: ...otentially hazardous The longer the duration of exposure and the greater the number of pulses the greater the risk of ocular damage Exposure to light from these instruments when operated at maximum ou...

Page 28: ...ration and a maximum energy of approximately 10 mJ at a wavelength of 1 064 nm At the focus of the laser beam a plasma is created which is at a high pressure and temperature but is spatially confined...

Page 29: ...cified intervals Modifications to the product or failure to follow the manufacturer s instructions may substantially reduce the expected service life and significantly increase the risk associated wit...

Page 30: ...ation lamp mounting 2 Forehead support application part 3 Height adjustment for chin rest 4 Chin rest application part 5 Clamp screw for fastening the instrument base 6 Connection cable for laser cons...

Page 31: ...n Lever tilted to the front towards the patient The base is locked Lever tilted to the rear towards the physician The base can be moved freely The index mark for mid position 12 Fig 3 indicates the ce...

Page 32: ...d a laser console 3 Fig 4 An optional foot switch 4 Fig 4 is available The laser console menu is used to switch between the hand and foot switches The VISULAS YAG III can be mounted to any table with...

Page 33: ...hanger 8 Halogen lamp cover see page 95 for replacing the lamp 9 Slit length control 10 Slit width control 11 Filter selector 12 Prism head Fig 5 LSL YAG III laser slit lamp The fastening screw 3 Fig...

Page 34: ...er arm The tonometer itself is attached by a magnet and fitted only when required Beam delivery in the LSL YAG III laser slit lamp An Nd YAG laser 1 Fig 6 mini laser module generates the therapy beam...

Page 35: ...Energy meter and pulse counter 5 Energy attenuator 6 Four point aiming beam diode laser 7 Aiming beam coupling mirror 8 Beam expander 9 Galilean magnification changer 10 Physician s safety filter 11...

Page 36: ...ol panel 6 Recessed grip Fig 7 VISULAS YAG III laser console 1 Foot switch connector 2 Door interlock connector 3 Serial port for servicing 4 Connector for combined operation with the VISULAS 532s VIS...

Page 37: ...of these values are outside the permitted range the system prevents the laser from being fired Laser triggering for example is automatically locked when the metered energy of the therapy beam is outs...

Page 38: ...13 32 Design of VISULAS YAG III Combi VISULAS Trion Combi VISULAS YAG III Combi VISULAS YAG III Combi is a combination of the VISULAS YAG III and VISULAS 532s devices consisting of the following compo...

Page 39: ...33 1 VISULAS YAG III laser head 2 LSL YAG III Combi laser slit lamp 3 Control panel of the VISULAS 532s laser console 4 VISULAS 532s laser console 5 VISULAS YAG III laser console Fig 7 6 Instrument ta...

Page 40: ...evice 000000 1272 175 GA GB 060613 34 VISULAS Trion Combi VISULAS Trion Combi is a combination of the VISULAS YAG III and VISULAS Trion devices consisting of the following components Fig 11 VISULAS Tr...

Page 41: ...d 2 LSL Trion Combi laser slit lamp 3 Control panel of the VISULAS Trion laser console 4 VISULAS Trion laser console 5 VISULAS YAG III laser console Fig 7 6 Instrument table optional 7 Standard foot s...

Page 42: ...ee page 95 for replacing the lamp 9 Slit length control 10 Slit width control 11 Filter selector 12 Prism head 13 VISULAS 532s VISULAS Trion laser spot size control Fig 13 LSL YAG III Combi LSL Trion...

Page 43: ...en required Beam delivery in the LSL YAG III Combi LSL Trion Combi laser slit lamp The laser beam is superimposed upon the slit illumination beam path so that the laser spot is coincident with the sli...

Page 44: ...er beam expander 4 Energy meter and pulse counter 15 Slit illumination system 5 Energy attenuator 16 Optical system for slit lamp and laser spot visualization 6 Four point aiming beam diode laser 17 C...

Page 45: ...on control panel and the combined knob button of the corresponding laser console The control knob button is used to adjust the system parameters in the individual operating modes by turning the knob P...

Page 46: ...udes the existence of a ground fault circuit interrupter GFCI To avert the risk of an electric shock this device may only be connected to a power supply with a protective ground conductor Ensure that...

Page 47: ...s The laser hazard area must be clearly demarcated and marked as such during laser operation Other safety precautions should be clarified with local authorities or with your laser safety officer Only...

Page 48: ...the optical fiber by hand only Do not use tools To avoid damage to the instrument remove the key before carrying out the installation Handle with care lift or carry the laser slit lamp by the base pl...

Page 49: ...the connector Disconnect the binocular tube from the slit lamp Unscrew the screws fixing the slit lamp base to the instrument table Remove the key from the key switch on the control unit Adjust the s...

Page 50: ...mm x 550 mm x 370 mm 4 Transport case open 5 Foot switch optional 6 Laser slit lamp with head rest 7 Laser console 8 Transport castors 9 Fixation lamp 10 Accessories packed 11 Laser safety goggles opt...

Page 51: ...e Remove the key from the key switch to prevent the unit from being inadvertently switched on during installation Mount the system in a suitable location close to the physician and the slit lamp To in...

Page 52: ...r console Fig 16 Instrument table with laser consoles 1 Slit lamp connector 2 Power input connector 3 Connector for combined operation with the VISULAS YAG III 4 Serial port for servicing 5 Door inter...

Page 53: ...elease the cable grasp the connector by the sleeve and pull it directly backwards Pulling on the sleeve releases the lock mechanism on the connector Install the door interlock on the VISULAS 532s 5 Fi...

Page 54: ...optical fiber by hand only Do not use tools Observe the user manuals of VISULAS Trion and the instrument table Avoid impact and blows during shipment of the device Mount the system in a suitable loca...

Page 55: ...ed Foot 2 5 Fig 19 For combined operation the VISULAS YAG III must be connected by a special combi cable to the VISULAS Trion For this purpose insert the end of the cable with the single plug into the...

Page 56: ...DAMAGE Connect only cables and sockets that are the same color and size Never use force To release the cable grasp the connector by the sleeve and pull it directly backwards Pulling on the sleeve rele...

Page 57: ...le as required and connect it to the front of the instrument see VISULAS Trion user manual Adjust the foot to the required angle and place the control panel in the location required Installation of ad...

Page 58: ...oving the VISULAS Trion Combi the cable connection to the VISULAS Trion must be pulled as the latter stands separately next to the instrument table and is not moved together with the table Read the us...

Page 59: ...splay field of the slit lamp To install proceed as follows Switch off the VISULAS YAG III and disconnect the power cable Carefully remove the desired eyepiece right or left 2 Fig 21 from the tube of t...

Page 60: ...ctivated in the INFO mode Example 35 4 mJ when the cumulative energy has been activated 28 when the sum of the delivered pulses has been activated When the focus shift display flashes change of focus...

Page 61: ...ght left hand button as viewed from the rear 1 Button for increasing brightness 2 Button for decreasing brightness Fig 22 ACCENTO eyepiece rear view brightness control buttons Follow the instructions...

Page 62: ...vice The ventilation slits in the casing should not be covered or otherwise obstructed WARNING RISK OF ELECTRIC SHOCK Please take care that the following operational requirements are met before using...

Page 63: ...st the following actions tests and initialization routines will be executed Switch on and initialization of the system Start of system monitoring Test and subsequent activation of watch dog circuit Te...

Page 64: ...his her hands In particular the instrument should not be used as a support or an aid for standing up CAUTION RISK OF PINCHING Various modules of the laser slit lamp can move against one another Take...

Page 65: ...bject plane of the slit lamp Center the slit projector and binocular tube to the slit lamp base On the slit lamp choose the highest magnification Open the slit Look through the eyepieces Use the joyst...

Page 66: ...eration of the device 000000 1272 175 GA GB 060613 60 Start up and laser treatment Control of the VISULAS YAG III is menu driven using the control panel Functions and menus are described in detail bel...

Page 67: ...iptions for the VISULAS YAG III Combi are shown from page 70 and the VISULAS Trion Combi from page 78 Menu navigation The VISULAS YAG III is operated via a menu system with four menu screens via the V...

Page 68: ...instrument is now in Power up mode Fig 24 Fig 24 Power up mode The system automatically performs a self test The start up screen includes a progress bar which shows the progress of the system test Wh...

Page 69: ...r slit lamp as a diagnostic slit lamp The VISULAS YAG III is used merely as a power source for the slit lamp The laser remains switched off and the hand switch or foot switch are deactivated Fig 25 Di...

Page 70: ...laser parameters can be set in this mode energy pulse mode and aiming beam intensity Each time the system is restarted the energy and the aiming beam intensity values most recently selected will be us...

Page 71: ...election and display of energy levels Energy levels When this field is activated the energy can be set using the control knob There are 22 energy levels In single pulse mode the lowest level correspon...

Page 72: ...this button switches the system into Treatment READY mode after approximately three seconds This transition time is visually indicated by a blinking button Touching this button again returns the syst...

Page 73: ...elect either hand switch or foot switch triggering The foot switch is not included as standard but is available as an option Touching this button switches the system into Diagnosis mode see page 63 La...

Page 74: ...t date and time by turning the rotary knob To save the settings and return to Information mode touch the button Touching the button also returns the system to Information mode but without saving any p...

Page 75: ...are always on Parameters are set in the same way as for Treatment STANDBY mode see page 64 When the trigger is activated the laser beam will be fired according to the parameters set WARNING RISK OF L...

Page 76: ...SULAS YAG III are described on page 61 Menu navigation The VISULAS YAG III is operated via a menu system with eight menu screens using the VISULAS 543s laser console Power up mode System information m...

Page 77: ...sole control panel will be deactivated and combination mode will be selected VISULAS 532s power up mode When the instrument is switched on using the key switch on the VISULAS 532s laser console see VI...

Page 78: ...slit lamp The VISULAS 532s is used merely as a power source for the slit lamp The laser module and temperature regulator remain switched off meaning that the ventilators are operated at minimum speed...

Page 79: ...on the YAG console as long as the system remains in combination mode and there are no system errors Fig 34 Should an error occur on the VISULAS YAG III whilst in combination mode the VISULAS 532s log...

Page 80: ...175 GA GB 060613 74 Fig 34 Combination mode is activated YAG III treatment mode In the main menu select the YAG laser as applicator Fig 35 Main menu after selecting the YAG laser as applicator Select...

Page 81: ...in Treatment READY mode and the aiming beam is switched on This display lights up in red when the laser is triggered In treatment mode the therapy beam can be applied via the LSL YAG III Combi laser s...

Page 82: ...of the aiming beam can be adjusted by turning the rotary knob A pulse counter is also displayed This can be reset to zero by touching the Reset button Touching the Arrow button returns you to the mai...

Page 83: ...r Treatment STANDBY mode When the trigger is activated the laser beam will be triggered according to the parameters set Touching the Standby Ready button returns you to Treatment STANDBY mode Touching...

Page 84: ...bi is operated via a menu system with five menu screens using the VISULAS Trion laser console Correct operation of VISULAS Trion is imperative for safe functioning Please familiarize yourself thorough...

Page 85: ...ontrol panel VISULAS Trion power up mode When the instrument is switched on using the key switch on the VISULAS Trion laser console see VISULAS Trion user manual the start up screen is displayed on th...

Page 86: ...lamp The VISULAS Trion is used merely as a power source for the slit lamp The laser module and temperature regulator remain switched off meaning that the ventilators are operated at minimum speed min...

Page 87: ...on the YAG console as long as the system remains in combination mode and there are no system errors Fig 42 Should an error occur on the VISULAS YAG III whilst in combination mode the VISULAS Trion lo...

Page 88: ...000000 1272 175 GA GB 060613 82 Fig 42 Combination mode is activated YAG III treatment mode If you wish to change the YAG trigger hand or foot press the upper blue YAG button in the main menu Fig 43...

Page 89: ...YAG trigger selection menu Select the YAG trigger hand foot The last selected trigger will be active upon restarting STANDBY Pressing the Arrow button in the YAG trigger selection menu will change to...

Page 90: ...appropriate parameter button and select the value required by turning the rotary knob Select the pulse mode required Pressing the rotary knob takes you directly to the entry field for the laser energ...

Page 91: ...reatment STANDBY mode When the trigger is activated the laser beam will be triggered according to the parameters set Touching the STANDBY READY button returns you to Treatment STANDBY mode Touching th...

Page 92: ...defocusing depending on the individual situation see Focus shift and defocusing page 88 Where there is astigmatic distortion the aiming beam spot pattern will take on a different appearance usually e...

Page 93: ...reason you should be particularly careful when working with silicone lenses The aiming beam spot pattern may also be distorted if the contact lens is held at too much of an angle You should therefore...

Page 94: ...the aiming beam focus This setting should only be used for applications in which the area to be treated is posterior to the tissue to be protected see also Fig 2 Anterior Labeled as ant switch to the...

Page 95: ...LAS YAG III is designed for pulse energies of up to about 1 5 mJ If you wish to work with higher energy levels e g for fibrotic secondary cataracts you must increase the focus shift distance by defocu...

Page 96: ...user manual Label the instrument clearly as being out of service and report the problem to the Carl Zeiss Meditec service Switching off the instrument WARNING RISK OF ELECTRIC SHOCK Internal componen...

Page 97: ...o liability for damages resulting from unauthorized tampering with the device or from the use of unapproved accessories Such actions will also render any warranty claims invalid Fault remedy Troublesh...

Page 98: ...perature Please wait a moment If this fault occurs frequently ensure that the instrument s ventilation slots are not covered and that the ambient temperature falls below 35 C Slit lamp not connected C...

Page 99: ...10 Fig 5 and Fig 13 Replace halogen bulb page 95 Poor slit illumination Selected lamp voltage too low Halogen bulb not properly inserted Slit length not correctly adjusted Slit width not correctly ad...

Page 100: ...use assembly of the laser console This assembly is located on the rear side of the laser console see 7 Fig 8 Switch the instrument off at the power switch Disconnect the power cable Open the flap 1 Fi...

Page 101: ...RISK OF BURNS Before replacing the lamp switch the system off at the key switch and disconnect the power cable Allow the lamp to cool down or wear protective gloves 1 Cover flap 2 Holders 3 Holder not...

Page 102: ...the socket plug 4 Fig 51 from the bulb 5 Fig 51 Then remove the defective bulb 5 Fig 51 Push a new bulb into the opening paying attention to the locating pins 7 Fig 51 Do not touch the bulb with the b...

Page 103: ...nst dust when not in use CAUTION PROPERTY DAMAGE The national disinfecting regulations must be observed in the choice of disinfectants and methods Please note that some cleaning agents and disinfectan...

Page 104: ...inted surfaces All painted surfaces may be cleaned with a damp cloth Do not use aggressive or abrasive cleaning agents Use spray or wipe disinfectants for cleaning and disinfecting the instrument case...

Page 105: ...y inspections may only be carried out by persons authorized by Carl Zeiss Meditec and solely according to the service instructions issued by Carl Zeiss Meditec For planning and implementing these safe...

Page 106: ...e for foot switch on IT 1060 or IT 760 Physician s safety filter for surgical microscope Active physician s safety filter simple for Zeiss M ller Wedel surgical microscope Active physician s safety fi...

Page 107: ...Laser safety goggles 532 561 Laser safety goggles 659 Laser warning lamp see laser warning lamp addendum Transport case for VISULAS YAG III Breathing shield Laser training eye with holder complete ki...

Page 108: ...beam Incorrect positioning of the contact lens will cause distortion of the laser focus This can lead to unwanted side effects Never trigger the laser if the aiming beam is not clearly visible in the...

Page 109: ...ns Focus diameter 10 m in air Focus shift between aiming beam and therapy beam Posterior 150 m therapy beam focus behind aiming beam Zero 0 m no focus shift between therapy and aiming beam Anterior 1...

Page 110: ...0 to 45 0 mJ 0 5 Hz 1 shots 2 s 33 kHz Energy attenuation 22 levels 2 4 6 8 10 12 14 16 20 24 28 32 36 40 42 48 56 60 64 70 80 100 Transmission Focus diameter 10 m in air Angle of exit aperture diver...

Page 111: ...IP 20 LSL YAG III Combi LSL Trion Combi laser slit lamp Instrument base motion range Lateral 110 mm Horizontal 90 mm Vertical 30 mm Slit lamp 12 V 30 W halogen lamp adjustable Slit length variable in...

Page 112: ...non condensing Altitude up to 3000 m above sea level Ambient conditions for the storage of all devices without original packaging Temperature 10 C to 55 C Relative humidity 10 to 95 non condensing Am...

Page 113: ...ended in this section CAUTION RISK OF ELECTROMAGNETIC RADIATION The VISULAS YAG may not be placed next to or stacked together with other equipment with the exception of device configurations described...

Page 114: ...missions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The VISULAS YAG III uses RF energy only for its internal function Therefore its RF emissions are very low an...

Page 115: ...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 interrupt...

Page 116: ...RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the f...

Page 117: ...imum 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 3...

Page 118: ...titut f r Normung German Institute for Standardization EMC Electromagnetic compatibility EN European Standard Fig Figure IEC International Electrotechnical Commission LSL Laser split lamp MPG Medizinp...

Page 119: ...18 Instrument table with VISULAS Trion Combi laser console 49 Fig 19 Connections on the VISULAS Trion laser console 50 Fig 20 Binocular tube and eyepieces 51 Fig 21 LSL YAG III laser slit lamp 53 Fig...

Page 120: ...gures 000000 1272 175 GA GB 060613 114 Fig 47 Focusing the aiming beam 86 Fig 48 Distorted aiming beam 86 Fig 49 Focus shift control 89 Fig 50 Replacing the fuse 94 Fig 51 Replacing the halogen bulb 9...

Page 121: ...ion 10 D Description of the device 24 Device classification 7 Disposal 10 E Electromagnetic compatibility 107 F Fault remedy 91 Figures 113 Function test 57 Functional description 22 Fuses 94 G Glossa...

Page 122: ...Index 000000 1272 175 GA GB 060613 116 Switching on 56 Symbols 5 U Useful life 23...

Page 123: ......

Page 124: ...Goeschwitzer Str 51 52 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www meditec zeiss com 000000 1272 175 GA GB 060613 VISULAS YAG III Specificati...

Page 125: ......

Page 126: ...oeschwitzer Str 51 52 07745 Jena Germany Phone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www meditec zeiss com 000000 1272 175 DokS GB 060613 VISULAS YAG III Specificat...

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