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background image

A

EMC declaration

1.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The VICTUS™ Femtosecond Laser Platform is intended for use in the electro‐

magnetic environment specified below. The customer or user of the

VICTUS™ Femtosecond Laser Platform should assure that it is used in such

an environment.

Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The VICTUS™ Femtosecond Laser Platform uses RF

energy only for its internal function. Therefore, RF emis‐

sions are very low and are not likely to cause any inter‐

ference in nearby electronic equipment.

RF emissions CISPR 11

Class A

The VICTUS™ Femtosecond Laser Platform is suitable for

use in all establishments other than domestic and those

directly connected to the public low-voltage power

supply network that supplies buildings used for

domestic purposes, under the provision that the fol‐

lowing warning is observed:
Warning: This device/system is solely intended for use

by healthcare professionals. This is a class A device/

system in accordance with CISPR 11. In a domestic envi‐

ronment this device/system may cause radio interfer‐

ence in which case the user may be required to take

adequate measures such as reorienting, repositioning

or shielding the VICTUS™ Femtosecond Laser Platform

or filtering the connection to the site.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker

emissions IEC 61000-3-3

Complies

APPENDIX

13

SKU: 70005780TPV * Version 6 * UM-100010770 GB

13 - 3

TPV Controlled Document / Status: Effective / Effective Date: Jun 14, 2017 2:38:46 PM

UM-100010770 / Version 6 / Page 203 of 207

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Summary of Contents for Victus

Page 1: ...User Manual VICTUS Femtosecond Laser Platform SW V3 3 SP02 UM 100010770 GB SKU 70005780TPV Version 6 ...

Page 2: ...rtion of this publication may be reproduced or made available to third parties in any form online or offline without the written consent of Technolas Perfect Vision GmbH Further no portion of this publication may be translated into a language or code that can be utilized for machines in particular data processing systems or the internet This document may exclusively be used to properly use the pro...

Page 3: ...abbreviations 1 2 1 5 Definitions 1 3 2 Safety 2 1 Intended use 2 1 2 2 Complications side effects 2 1 2 3 Important safety considerations 2 3 2 4 Responsible organization 2 3 2 5 Customer responsibilities 2 4 2 6 Personnel requirements 2 4 2 6 1 Role definitions 2 4 2 7 General hazards 2 5 2 7 1 Electrical hazard 2 6 2 7 2 Laser radiation hazard 2 7 2 7 3 Fire hazard 2 7 2 7 4 Mechanical hazard 2...

Page 4: ...4 1 4 1 1 Interface of the patient beds LS Comfort and Patient Support System S60 by AKRUS GmbH Co KG 4 2 4 2 Service and calibration 4 3 4 3 Decomissioning and disposal 4 3 5 Clinical applications 5 1 Medical indications 5 1 5 2 Patient selection criteria 5 2 5 2 1 Contraindications 5 2 5 3 Available procedures 5 3 5 3 1 Cataract procedures 5 3 5 3 2 Corneal procedures 5 4 5 3 3 Therapeutic proce...

Page 5: ...microscope and its illumination 6 8 6 2 9 1 Adjusting the surgical microscope illumination 6 10 6 2 10 Footswitches 6 11 6 2 11 Patient bed 6 12 6 2 11 1 Referencing the patient bed 6 12 6 3 Cleaning instructions 6 13 7 Accessories and tools 7 1 Accessories 7 1 7 2 Tools 7 2 8 Software 8 1 Working with the software 8 1 8 1 1 Starting and closing the software 8 1 8 1 2 Elements of the Main menu scr...

Page 6: ...plates 8 33 8 4 10 Treatment records 8 33 8 5 Procedure parameters 8 34 8 5 1 Parameters for capsulotomy 8 36 8 5 2 Parameters for lens fragmentation 8 37 8 5 3 Parameters for arcuate incisions 8 40 8 5 4 Parameters for corneal incisions 8 43 8 5 4 1 Schematic overview on corneal incisions 8 46 8 5 5 Parameters for flap 8 48 8 5 6 Parameters for penetrating keratoplasty 8 50 8 5 7 Parameters for l...

Page 7: ...145 9 18 9 4 4 Docking the patient to the spacer cone 9 22 9 4 4 1 For capsulotomy and lens fragmentation procedures using a headrest with inte grated joystick 9 23 9 4 4 2 For capsulotomy and lens fragmentation procedures using a headrest with external joysticks 9 25 9 4 4 3 For all other procedures using a headrest with integrated joystick 9 26 9 4 4 4 For all other procedures using a headrest w...

Page 8: ...ns 11 1 11 2 Operating conditions 11 3 11 3 Laser specifications 11 4 11 4 Transport and storage conditions 11 4 11 5 Electrical connection 11 4 12 Index 13 Appendix TABLE OF CONTENTS SKU 70005780TPV Version 6 UM 100010770 GB 6 ...

Page 9: ...your system s configuration the depicted screenshots may not be identical to the screen shown on your system The software user interface may only be available in English Where applicable the Appendix section of the user manual contains a list of the English software texts together with the appropriate translation A 2 Explanation of symbols Safety notes in this user manual are introduced with symbo...

Page 10: ...tomatic sequence as a result of action References to chapters in this user manual Lists or list entries without a certain sequence Ctrl Keys on the keyboard mouse buttons key switches hardware switches or hardware buttons Start Active clickable GUI elements Patient selection Passive elements c Program Text input Administration è User Registry Menu path A 3 Customer service Our customer service div...

Page 11: ... Interface 125 REF 90000145 PI 125 REF 90000145 Suction Clip 125 in general suction clip Suction Clip 125 REF 90000115 suction clip REF 90000115 Suction Clip 125 REF 90000145 suction clip REF 90000145 VICTUSä Femtosecond Laser Platform VICTUSä Femtosecond Laser Platform or generic term laser system A 5 Reference documents to this user manual The following reference documents are related to this us...

Page 12: ...GENERAL INFORMATION A SKU 70005780TPV Version 6 UM 100010770 GB A 4 ...

Page 13: ...ical breakdown or photodisruption with practically no heat This results in the formation of gas bubbles The user can arrange these patterns in various ways so that various surgical inci sions are possible for example a laser generated LASIK flap For details refer to Ä Chapter 5 3 2 Corneal procedures on page 5 4 Furthermore the laser system is able to perform various therapeutic treatments For det...

Page 14: ...ystem S60 by AKRUS GmbH Co KG These patient beds are medical devices that are approved in accordance with the Medical Device Directive Technolas Perfect Vision GmbH has assessed their use in combination with VICTUS Femtosecond Laser Platform Technolas Perfect Vision GmbH allows only specific versions of the LS Comfort or the Patient Support System S60 patient bed to be used with VICTUS Femtosecond...

Page 15: ...y LVC Laser Vision Correction ME Medical Electronic e g Medical Electronic Equipment NOHD Nominal Ocular Hazard Distance OCT Optical Coherence Tomography PETG Polyethylene Terephthalate Glycol PI Patient Interface PIK Patient Interface Kit PKP Penetrating Keratoplasty UPS Uninterruptible Power Supply Registered trade mark ä Trade mark 1 5 Definitions LRCS LRCS indicates a set of procedures that in...

Page 16: ...INTRODUCTION 1 SKU 70005780TPV Version 6 UM 100010770 GB 1 4 ...

Page 17: ...er system is also intended to be used only as described in the instructions in this user manual Any use that exceeds or is different from the specified intended use is consid ered to be misuse Danger of injury due to misuse Misuse of the laser system may lead to dangerous situations and severe inju ries Do not use the laser system on patients who come under the exclusion criteria Ä Chapter 5 2 1 C...

Page 18: ... Damage to intraocular structures n Miosis Potential complications resulting from creation of corneal flaps or corneal cuts incisions include but are not limited to the following n Corneal edema n Epithelial ingrowth n Incomplete flap or corneal cuts incisions creation n Flaps and LKP only Flap striae Flap graft tearing or incomplete lift Photophobia Thick or thin flap graft Vertical gas breakthro...

Page 19: ...erved to verify normal operation in the configuration in which it will be used Do not stack or locate any non intended devices next to the product during operation The medical electrical equipment implies special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in Ä Appendix A EMC declaration on page 13 3 The medical electrical equi...

Page 20: ... if persons are unauthorized or insufficiently qualified If unauthorized or unqualified persons perform work on the laser system or are in the danger zone of the laser system hazards may arise that can cause serious injury and substantial damage to property All treatments must be performed by appropriately qualified persons Unauthorized persons must not use the product All persons are expected to ...

Page 21: ...tem including special precautionary measures for working with laser emitting sys tems Users know the content of all regulations guidelines and standards that are applicable for the safe use of the system and can implement the requirements mentioned in them Users have the necessary technical knowledge of the application area of the system for which they are responsible and rigorously follow all hyg...

Page 22: ...ouch the patient at the same time as live parts for example USB ports or connectors Danger of injury due to the incorrect handling of rechargeable batteries If rechargeable batteries are handled incorrectly there is a risk that they explode or that harmful liquid leaks from them In case of skin contact the liquid can cause chemical burns The liquid is highly toxic if swallowed and eye contact may ...

Page 23: ...ce Technicians have to refer to field service note FSN 1302 VICTUS FEMTEC EXCIMER Safety Goggles Danger of serious injury due to incorrect operation or maintenance of the laser system Use of operating options adjustments or performance of procedures other than those specified in this user manual may result in hazardous radiation exposure Never operate the laser system other than specified in this ...

Page 24: ...xygen enriched environment 2 7 4 Mechanical hazard Danger of injury from tripping If the power cable is laid in the open there is a risk that someone can trip over the cable and be injured The power plug and the unit can also be dam aged Lay the power cable in a place where it cannot be tripped over by per sonnel Always connect the power plug in a safe position where it cannot be damaged or destro...

Page 25: ...esponding system The meaning of colors on the shear force display and in the software GUI fol lows the principle of traffic lights n A flashing visual signal may be displayed on the LED bar display of the vacuum pump unit if a serious error in the vacuum pump unit has occurred 2 9 Safety devices Danger to life from non functional safety devices If safety devices are not functioning or are disabled...

Page 26: ...ser Stop button towards you so that a restart is possible n Press the Reset button Fig 9 5 After 2 seconds the Reset button is no longer illumi nated normal operation The integrated illumination in the Laser Stop button is illuminated red normal operation Depending on the headrest connected to the patient bed please note the following warning Headrest with external joysticks Headrests with integra...

Page 27: ... bed user manual by AKRUS GmbH Co KG Ask the patient to leave the patient bed very carefully Before unlocking the Laser Stop button ensure that the cause of the laser stop has been removed Do not unlock the Laser Stop button until there is no more danger and there is no patient lying on the patient bed 2 10 Labeling Danger of injury due to illegible labels Over time labels and signs can become dir...

Page 28: ... work places where laser beams are used and they are not permitted to operate laser emitting equipment The equipment should only be operated when the user is sure that the laser output cannot damage eyes burn skin or tissue or result in damage to protective work clothing or other objects Never look directly into the laser source Invisible laser radia tion large INVISIBLE LASER RADIATION AVOID EXPO...

Page 29: ...s on the laser system Fig 1 Front view Pos Label 1 Laser beam small label caution when cover is open 2 No heavy loads 3 Laser beam small label laser aperture SAFETY 2 SKU 70005780TPV Version 6 UM 100010770 GB 2 13 ...

Page 30: ...Fig 2 Side view Pos Label 1 Laser beam small label laser aperture 2 Laser beam small label caution when cover is open 3 Consult operator s manual SAFETY 2 SKU 70005780TPV Version 6 UM 100010770 GB 2 14 ...

Page 31: ...ply of the laser system 3 Power patient bed 4 Vacuum footswitch 5 Interlock patient bed interlock cable 6 Procedure footswitch 7 OP camera 8 Camera live image 9 Interlock external 10 Laser beam large label invisible laser radiation 11 Patent label SAFETY 2 SKU 70005780TPV Version 6 UM 100010770 GB 2 15 ...

Page 32: ...at the laser output cannot damage eyes burn skin or tissue or result in damage to protective work clothing or other objects Never look directly into the laser source Caution when cover open Caution Class 4 Invisible laser radiation when open Avoid eye or skin exposure to direct or scattered radia tion No heavy loads Do not lean or put heavy loads on the designated com ponent Laser aperture Laser a...

Page 33: ...ction for the Vacuum footswitch Interlock Patient Bed This label indicates the location of the plug for the patient bed interlock Procedure foot switch This label indicates the connection for the Procedure footswitch OP Camera This label indicates the location of the plug for the OP camera Camera Live Image This label indicates the location of the plug for the video camera Interlock external This ...

Page 34: ...d to provide for recycling at the end of its useful life Technolas Perfect Vision GmbH fully complies with the WEEE Directive This symbol on the product indicates that it must be separately collected and recycled in order to protect human health and the environment In that regard Technolas Perfect Vision GmbH will arrange the collection and recycling of end of life Tech nolas Perfect Vision GmbH e...

Page 35: ...S Femto second Laser Plat form with serial number TFW 0110 see back side of the laser system The type plate contains the following information n Unit type n Manufacturing date Year Month Day n Serial number n Supply mains n Power consumption n Mode n Classification n Unique device identification UDI n Manufacturer n CE Mark with the number of the Notified Body Installed software This label is loca...

Page 36: ...is man ufactured or used Vacuum foot switch The Vacuum footswitch is labeled with the Vacuum label and labels from the footswitch manufacturer Procedure label The Procedure footswitch is labeled with the Procedure label and labels from the footswitch manu facturer Follow the instruc tions Consult operator s manual SAFETY 2 SKU 70005780TPV Version 6 UM 100010770 GB 2 20 ...

Page 37: ... the required documents are given to the carrier in perfect condi tion The documents state the type and content of the delivered goods Check the delivery note to ensure the completeness of the delivery The carrier is respon sible for delivering the product promptly and in perfect condition Should a loss of parts or damage occur during transportation the delivery company is respon sible If there ar...

Page 38: ...t be stored in a secure and dry place before installation and initial use 3 4 Unpacking After delivery the product must be unpacked and installed by an Authorized Service Technician exclusively Hazards due to unauthorized unpacking Removal of the transport safety device in the wrong sequence may result in damage The product must only be unpacked by Authorized Service Technicians The product must n...

Page 39: ...re allowed for usage or replacement Any damage caused by the improper usage of unauthorized accessories tools or devices will void the certification and the warranty Furthermore it may lead to increased emissions or decreased immunity of the equipment Do not use other accessories tools devices than the ones specified in this user manual After longer periods out of operation the conditions specifie...

Page 40: ...ystick s 3 Power supply 4 Main switch Pos Interface port 1 Interlock cable 2 Not used 3 Power supply 4 Main switch Interface ports at the VICTUS Femtosecond Laser Platform Fig 4 Interface ports at the VICTUS Femtosecond Laser Platform Interface ports at the patient bed LS Comfort Fig 5 Interface ports at the patient bed LS Comfort Interface ports at the patient bed Patient Sup port System S60 Fig ...

Page 41: ...d Service Technicians If system checks fail or other errors occur service must be performed as soon as pos sible The service and calibration interval is 6 months The expected service life is 5 years 4 3 Decomissioning and disposal Danger of injury in conjunction with improper decommissioning and dis posal Stored residual energies and components featuring edges tips and corners on and inside the la...

Page 42: ...INSTALLATION COMMISSIONING SERVICE CALIBRATION DECOMISSIONING AND DISPOSAL 4 SKU 70005780TPV Version 6 UM 100010770 GB 4 4 ...

Page 43: ...Procedure Cataract Capsulotomy Cataract Lens fragmentation Cataract Corneal incisions In addition arcuate incisions are available as part of a cataract treatment Medical indication Procedure LASIK flap Flap Medical indication Procedure Miscellaneous diseases of the cornea Penetrating keratoplasty PKP Keratoconus Intracorneal ring segments tunnel ICRS tunnel crosslinking CXL Opacity of the cornea o...

Page 44: ...the intended treatment like glaucoma and suspected glaucoma diabetes mellitus retinal disorders rheumatic diseases occlusion of retinal vessels pellucid marginal degeneration herpes zoster or herpes simplex keratitis heavy vascularization of the ocular tissue epilepsy recurrent corneal erosion severe basement membrane disease patients who suffer from severe wound healing disorders such as con nect...

Page 45: ...s produced by the procedure can escape n Corneal thickness requirements that are beyond the range of the system n Keratoconus and suspected keratoconus only applicable for arcuate incisions n Previous corneal surgery of any kind 5 3 Available procedures Danger of injury due to the failure to observe the patient selection criteria Failure to observe the contraindications may result in serious perma...

Page 46: ...ts can be verified by the video image 5 3 2 Corneal procedures The corneal treatment comprises the following procedure n Flap This procedure cuts a corneal flap The flap is generated by cutting a bed parallel to the anterior surface of the cornea and a rim or side cut with a hinge This proce dure enables the user to define flap parameters such as the depth the diameter of the bed the position and ...

Page 47: ...sually performed when a superficial injury opacity or scarring of the cornea reduces visual acuity The damaged cornea is removed and replaced by a healthy donor cornea Lamellar keratoplasty has the advantage of being primarily extraocular and therefore preserves the recipient endothelium This procedure allows the user to cut the donor and recipient cornea with matching diameters and rim angles Thi...

Page 48: ...CLINICAL APPLICATIONS 5 SKU 70005780TPV Version 6 UM 100010770 GB 5 6 ...

Page 49: ...ated in the laser system 1 Main unit 2 Assistant workstation 3 Start up panel 4 Suction status controller and force display 5 Panel with knob for switching on off laser ring light and another knob for shifting the camera focus between corneal and lens treatments 6 Spacer cone with protection cover 7 Surgeon control screen 8a Surgical microscope optional 8b Surgical microscope with illumination uni...

Page 50: ... system Laser source Generates the laser beam Optical unit Controls the complete laser beam path Surgeon control screen Shows a life camera image a life OCT image and all relevant parameters for the selected treat ment Treatment illumination Contains the laser ring light module It illuminates the treatment area OCT Monitors cataract corneal and therapeutic treatments The core of the main unit is t...

Page 51: ...rotating arm and can be tilted The surgeon control screen displays a live camera image and a live OCT image for cataract corneal and therapeutic treatments The screen also shows all relevant information about the main treatment parameters vacuum and pressure status as well as treatment progress 6 2 2 1 Adjusting the monitor settings For best visual accuracy it is recommended not to run the monitor...

Page 52: ...Stop function Property damage due to use of unauthorized accessories tools devices Only USB memory sticks specified in this user manual must be inserted into the USB ports Do not insert other tools than the one specified in this user manual into the USB ports Failure to observe these instructions may damage the laser system 6 2 3 1 Switching the laser system on and off 1 Turn the system key Fig 9 ...

Page 53: ...controller Fig 10 allows the user to set the suction pressure for the suction clip The vacuum decrease increase is indicated by means of the LED bar display Fig 10 1 The range is from 350 mbar 1 LED illuminated to 550 mbar 10 LEDs illuminated 6 2 4 1 Adjusting the suction status It is not possible to exceed the preset standard suction range in either direction Turn the controller Fig 10 2 clockwis...

Page 54: ...rmation about the pressure If Fig 11 2 is referred to this LED will be stably illuminated when the docking pressure is correct This is only valid for cataract treat ments except for the arcuate incisions procedure and the corneal incisions procedure 3 Shear force LEDs 25 LEDs display the shear forces that are exerted on the eye Fig 11 3 The LEDs are arranged in a circle 4 WORKING control LED After...

Page 55: ... switch Fig 12 2 allows to shift the camera focus for corneal and lens treatments 6 2 7 1 Adjusting the camera focus By turning the switch CAM FOCUS Fig 12 2 clockwise the OP camera focuses on the lens and by turning the switch counterclockwise the OP camera focuses on the cornea 6 2 8 Spacer cone Property damage due to an unprotected spacer cone The spacer cone is very delicate and may be damaged...

Page 56: ...0000145 6 2 8 1 Protecting the spacer cone 1 Slide the protection cover Fig 13 into the slot 2 Turn the protection cover clockwise until it engages 6 2 9 Surgical microscope and its illumination The surgical microscope and the surgical microscope illumination are optional com ponents The surgical microscope allows the surgeon to center the suction clip on the patient s eye Fig 13 Spacer cone with ...

Page 57: ... Pos Filter Filter description UV UV filter Yellowness of the light recommended for ophthalmology Wide aperture 5 mm Optimum color fidelity Spot 2 65 mm Optimum color fidelity Mini spot 0 25 mm Optimum color fidelity DF Daylight filter Adaptation of halogen light to daylight Blue Blue filter Stimulation of fluorescence temporary application with flourescein Surgical microscope components Surgical ...

Page 58: ...e surgical microscope is permanently switched on 1 Remove the cover of the surgical microscope illumination Fig 15 2 Switch on the I 0 power switch at the rear panel of the surgical micro scope illumination Fig 16 3 Adjust the illumination with the finger touch slider at the front panel Fig 17 4 Close the cover of the surgical microscope illumination For surgical microscope illu minations that are...

Page 59: ...ro scope illumination by pressing the left footswitch Fig 18 6 2 10 Footswitches Procedure footswitch Vacuum footswitch The Procedure footswitch has a red label and starts and controls the proce dures The Vacuum footswitch has a blue label and activates deactivates the vacuum of the suction clip It is impossible to deactivate the vacuum of the suction clip with the Vacuum foot switch during the tr...

Page 60: ... ment than the laser system may result in the loss of the ME system safety Ensure that the power cable at the patient bed is connected to the inter face port Power patient bed at the laser system This figure Fig 19 shows an example of a patient bed that can be combined with the VICTUS Femtosecond Laser Platform 6 2 11 1 Referencing the patient bed If the patient bed LS Comfort or Patient Support S...

Page 61: ...ly alkaline cleaning agent Use only soft lint free cleaning cloths Part of the laser system Cleaning agent All matte surfaces Neutral or slightly alkaline cleaning agent All lacquered surfaces Neutral or slightly alkaline cleaning agent Spacer cone Alcohol Oculars of the microscope Alcohol LCD screens Commercially available cleaning kits for computers Keyboard and mouse of the assistant work stati...

Page 62: ... and are made of plastics Do not use cleaning agents or abrasive powders that dissolve plastics Ensure that no moisture enters the assistant workstation or the surgeon control screen Ensure that the ventilation slots of the monitors remain open 3 Follow the instructions on the cleaning kit for computers to clean the assis tant workstation and the surgeon control screen 1 Switch off the laser syste...

Page 63: ... 125 REF 90000145 must only be used with the VICTUSä Femtosecond Laser Platform software version 3 3 and higher The PI 125 REF 90000145 resembles a contact lens The wider side 1 is sucked to the spacer cone of the laser system The smaller side 2 contacts the corneal surface of the patient s eye The product is sterile and for single use only WARNING Ensure that the PI 125 REF 90000145 is only used ...

Page 64: ... clip REF 90000145 is only used together with the PI 125 REF 90000145 7 2 Tools User key The user key stores and manages licenses for treatment procedures The user key uses patented embedded encryption hardware and works exclusively with the VICTUS Femtosecond Laser Platform system software Detector head The detector head is a part of the power meter and is used to perform the power test Digital s...

Page 65: ...te holder is a holder for the adapters used to perform the pressure test and the depth test Short adapter The short adapter is used to perform the pressure test Suction reservoir The suction reservoir is used to perform the vacuum test and is inserted into the suction port of the laser arm ACCESSORIES AND TOOLS 7 SKU 70005780TPV Version 6 UM 100010770 GB 7 3 ...

Page 66: ...Support block The support block is used during all system tests ACCESSORIES AND TOOLS 7 SKU 70005780TPV Version 6 UM 100010770 GB 7 4 ...

Page 67: ...e due to aborted warm up of the laser system The laser system must only be used after the warm up has been completed If you do not allow the laser system to warm up properly the entire laser system may be permanently damaged Do not abort warm up For initial start up wait at least 20 minutes after having turned the system key to the On position Only after waiting that 20 minutes press the blue Rese...

Page 68: ...erformed successfully n If the system self test has been performed successfully you can login after a few seconds Fig 22 Fig 22 System self test performed successfully After the application has been started Fig 23 the login screen appears Fig 25 Fig 23 Starting application System self test failed n If the system self test failed the Startup menu dialog box appears Fig 24 SOFTWARE 8 SKU 70005780TPV...

Page 69: ... formed successfully log in the software Ä Log in the software on page 8 4 Pos Button Field Description 1 Login button The Login button is disabled Click to log in the software once the problem fault has been rectified 2 Open Tool Box button Opens the Tool Box software to perform troubleshooting system modifications and or adjustments at the laser system by an Authorized Service Technician 3 Downl...

Page 70: ...field Enter your user name and your password Click Log in 2 Quit button Closes the software and leads back to the startup menu 1 Type in your user name and password Fig 25 1 2 Click Log in 3 Click the Select treatment mode LRCS Corneal button Fig 27 4 if neces sary Fig 26 Select treatment mode screen ð The Select treatment mode screen Fig 26 opens Log in the software SOFTWARE 8 SKU 70005780TPV Ver...

Page 71: ...in menu screen after login example with Flap 160 kHz Pos Button Field Description 3 Information header Shows information about the name of the relevant menu or screen the surgeon s name the patient s name the patient s date of birth and the patient s ID 4 Select treatment mode LRCS Corneal button Opens the Select treatment mode screen refer to Fig 26 5 System test button Opens the System test scre...

Page 72: ...nt mode 12 Information field Pressure Shows the actual pressure at the spacer cone 13 Information field FEMTOCLICK Shows whether a user key is connected to the laser system In this case the status field is highlighted green If not the status field is highlighted red 14 Information field System test Shows information about the status of the system tests 15 Log out button Logs out the user 8 1 3 Ele...

Page 73: ...ements of the Treatment planning screen example Fig 29 Elements of the Treatment summary screen example Treatment planning screen Treatment summary screen SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 7 ...

Page 74: ... Regular docking and treatment alignment screen example Fig 31 Elements of the Treatment screen example Regular docking and treatment alignment screen Treatment screen SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 8 ...

Page 75: ...ontrol 6 OD or OS Shows the eye that shall be treated 6 OCT B scan image Shows the real time OCT B scan image of the patient s eye 7 Procedure parameters dialog boxes Click to view or specify the procedures parameter values 8 Approve button Click to verify the procedures parameter values 9 Back button Click to return to the previous screen 10 Treatment summary overview Shows a summerized overview ...

Page 76: ...r Starts running after the Eye suction is enabled and stops when eye suction clip vacuum is lost 16 Treatment progress bar Shows the progress during performing the treatment 17 Continue button Click Continue to open the Treatment result screen 18 Procedures dialog box Shows the treatment results 19 Remaining licenses dialog box Shows the available enabled procedures and the respective number of av...

Page 77: ... Treatment specific elements Fig 33 Elements of the LRCS Treatment planning screen example Fig 34 Elements of the LRCS Soft docking screen example LRCS SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 11 ...

Page 78: ...Fig 35 Elements of the LRCS Treatment alignment lens screen example Fig 36 Elements of the LRCS Treatment alignment cornea screen example SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 12 ...

Page 79: ...lor coded displayed in the real time video 5 LRCS parameter values dialog boxes Open the relevant dialog boxes to view or edit the respective parameter values 6 OCT B scan image Shows the real time OCT B scan image of the patient s eye The flashing camera symbol represents the periodical updating of the OCT B scan image 7 Restart recognition button To restart the OCT supported identification of oc...

Page 80: ...ck the Confirm button to accept all workflow settings 14 buttons To increase the rim height of the capsulotomy click the button To decrease the rim height of the capsulotomy click the button 15 Center to lens apex button To center the capsulotomy and the lens fragmentation procedures to the lens apex click the button 16 3 click centration button To mark the pupil margin click the 3 click centratio...

Page 81: ...ap parameters that can be changed last minute before starting the procedure All other flap parameters are unchangeable at this point It is only possible to change these parameters in the respective Treatment planning screen 3 Center to pupil button Click the Center to pupil button to center the flap automatically to the center of the pupil as far as possible Flap SOFTWARE 8 SKU 70005780TPV Version...

Page 82: ...nged last minute before starting the procedure All other therapeutics parameters are unchangeable at this point It is only possible to change these parameters in the respective Treatment planning screen 3 3 click centration button If you do not agree with the results of the automatic identification of the ocular structures click the 3 click centration button to determine the pupil margin or the li...

Page 83: ...ystem in the treatment mode that was last used 2 Date format drop down selection Select the date format that applies to the patient data and treatment data 3 Enable corneal incision previews check box Activate this check box to enable or to disable the OCT B scan images of the corneal incisions during the treatment 4 Perform post op OCT scans of arcuate and corneal incisions for the treatment reco...

Page 84: ...the software after an emergency shutdown Ensure that no patient or equipment are attached to the spacer cone 1 If required undock the patient or the equipment and click Confirm ð The software will shut down Wait for the forced shutdown to close all programs 2 Press the Reset button Fig 41 5 at the start up panel 3 Wait for approximately 30 minutes until the reconnection is completed 4 Continue as ...

Page 85: ...atient data Ä Chapter 8 4 4 Deleting patient data on page 8 26 3 View treatments 3 Create new treatments Ä Chapter 8 4 6 Creating treat ments on page 8 28 3 Edit treatment data Ä Chapter 8 4 7 Editing treatments on page 8 32 3 Delete treatment data Ä Chapter 8 4 8 Deleting treat ments on page 8 32 3 View user data 3 Add new users Ä Chapter 8 2 2 Adding users on page 8 20 3 Edit registered user acc...

Page 86: ...dd the corresponding user profile to the user Field Description Username Specifies the user name for login minimum 6 characters Mandatory Full name Specifies the user s full name Mandatory User type n Admin n User Shows the registered user profiles Select the corresponding user profile for the new user Password Specifies the user s password minimum 6 characters Mandatory To confirm enter the passw...

Page 87: ...test chiller The laser system automatically performs a system self test regarding the functionality of the system components The results of the functionality test for the chiller are displayed on the Chiller screen automatically n after the laser system has been switched on Laser position test The laser position sensor LPS checks the proper function of the laser scanner mirrors as well as the inte...

Page 88: ...x for the associated system test screen You can proceed as folllows n Perform the Laser position test n Perform the startup tests n Verify the results of the automatic functionality test for the chiller Status indicator Explanation gray System test has not been performed yet green Test parameters are within the acceptable range You can proceed with the next test or procedure red A system error has...

Page 89: ...escription 1 Patients dialog box Manage patient data You can select patient data create new patient records modify or delete patient data 2 Treatments dialog box Manage patient data You can select treatment records modify or delete data in selected treat ment records If treatments have already been performed the treatment records can be viewed 3 Add treatment dialog box Create new treatments 4 Bac...

Page 90: ...og box Fig 49 Add patient dialog box 2 Enter the patient data Ä Table on page 8 24 in the fields described below All mandatory fields must be filled in otherwise the OK button will not be enabled Pos Field Name Description 1 First name Specifies the patient s first name 2 Last name Specifies the patient s last name SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 24 ...

Page 91: ...ew patient is added to the database 8 4 2 Selecting patients The Patients dialog box must be opened Fig 47 1 in the Patient selection screen 1 To search for a specific patient enter at least the first characters of the patient s first name last name date of birth or identifier in the search box Fig 48 1 of the Patients dialog box ð The search result is highlighted Fig 48 2 2 Click in the row with ...

Page 92: ...esponding patient data Fig 50 4 Click the OK button to apply any changes 8 4 4 Deleting patient data Only data from patients who have not been treated yet may be deleted 1 Select the patient that you want to delete as described in Ä Chapter 8 4 2 Selecting patients on page 8 25 2 Click the Delete button Fig 48 5 3 To delete the patient data confirm with Yes in the warning message SOFTWARE 8 SKU 70...

Page 93: ...on the row with the appropriate treatment Fig 51 Treatments dialog box ð The selected treatment is highlighted Fig 51 1 2 Click the Select button Fig 51 2 Fig 52 Treatment summary screen example ð The Treatment summary screen Fig 52 opens So you can verify the parameter values before starting the treatment 3 Continue with Ä Chapter 9 Treatment on page 9 1 SOFTWARE 8 SKU 70005780TPV Version 6 UM 10...

Page 94: ...Select Flap Fig 53 1 to create a flap procedure LRCS Fig 53 2 to create a cataract treatment or Therapeutics Fig 53 3 to create a thera peutic treatment Fig 54 Flap Template selection screen example ð The Template selection screen Fig 54 opens to create a new treat ment based on determined parameter default values or on a desig nated template SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 ...

Page 95: ...ses a treatment Fig 55 5 Default button Creates a new treatment template based on determined parameter default values 6 Designated template Creates a new treatment template based on a designated template 7 Cancel button Returns to the previous Template selection screen Fig 54 Fig 57 8 Save template button Saves a treatment template 9 Parameter values dialog boxes Open the relevant dialog boxes to ...

Page 96: ...reen opens Fig 55 2 Click the Default button Fig 55 5 3 To save the new treatment template enter a name in the entry field Fig 56 and confirm with the OK button Fig 57 Flap Treatment planning screen new template ð The Treatment planning screen Fig 57 based on the determined parameter default values opens 4 View or modify the corresponding treatment data Fig 57 9 Fig 56 Add template dialog box SOFT...

Page 97: ...ate selection screen Fig 58 to create a new treatment which is based on determined parameter values for a particular patient 2 In the Treatment planning screen Fig 57 view or modify the corre sponding treatment data 3 To save the changed treatment template click the Save template button 4 Enter a new template name and confirm with the OK button ð The treatment can now be executed Fig 59 Save templ...

Page 98: ...ter values 4 To save any changes click the Exit treatment button and confirm with Yes 8 4 8 Deleting treatments Deleting a treatment is only possible if the treatment has not been performed yet Precondition A patient must be selected see Ä Chapter 8 4 2 Selecting patients on page 8 25 1 Select the treatment that you want to delete as described in Ä Chapter 8 4 5 Selecting treatments for execution ...

Page 99: ...onfirm with Yes 8 4 10 Treatment records A treatment record contains the following information n GUI software version n User surgeon name n Patient data n Intervention date n Images from the OP camera before the intervention n Images from the OCT B scan before the intervention n Treatment status n Parameter values n Images from the OP Cam after the intervention n Images from the OCT B Scan after t...

Page 100: ...lick the Treatment record button Fig 51 4 in the highlighted row 3 Insert a USB memory stick in the USB port at the start up panel 4 Click the Export button in the Treatment record screen ð The treatment record s data is now saved on the USB memory stick 8 5 Procedure parameters For detailed information about the relevant procedure parameter values refer to the addendum VICTUS Femtosecond Laser Pl...

Page 101: ...d appropriate for the intended treatment The failure to verify such parameters may result in serious permanent patient injury Verify that the selected procedure parameters are appropriate for the selected treatment and can be applied safely L WARNING SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 35 ...

Page 102: ...Options Fig 64 Capsulotomy Options dialog box 3 To close the Capsulotomy Options dialog box click Close 4 To close the Capsulotomy dialog box click the arrow upwards symbol Parameters Parameter dialog box Definition Diameter mm The diameter is determined by the cutting circle rim Rim height µm Height of the shot capsulotomy Energy µJ Energy level of each single pulse when cutting the rim Spot spac...

Page 103: ...attern will have a minimal distance to the iris margin as given by the radial safety dis tance to pupil margin 8 5 2 Parameters for lens fragmentation Precondition n A lens fragmentation procedure must be selected Fig 65 Fig 65 Lens fragmentation dialog box For general information about how to view or specify parameter values refer to Ä Chapter 8 5 1 Parameters for capsulotomy on page 8 36 Paramet...

Page 104: ...mbol Ä Table on page 8 38 to open the associated dialog box Type Symbol Dialog box Circular cuts Radial cuts Circular cuts Radial cuts Grid Parameters Parameter dialog box Definition Number of circles Number of circular cuts Lens fragmentation dialog boxes SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 38 ...

Page 105: ...ting the rim Number of circles Number of circular cuts Diameter mm Diameter of the largest circle Number of radials Number of radial cuts Diameter mm Diameter of the largest circle Grid size µm Grid size in the real time video Diameter mm Diameter of the largest circle The other parameters values are identical to the Circular cuts Radial cuts parameters SOFTWARE 8 SKU 70005780TPV Version 6 UM 1000...

Page 106: ...e anterior lens surface in a vertical manner Posterior safety distance µm Minimum distance between the lens fragmentation pattern and the posterior lens surface in a vertical manner 8 5 3 Parameters for arcuate incisions Precondition n An arcuate incisions procedure must be selected Fig 67 Fig 67 Arcuate incisions dialog box For general information about how to view or specify parameter values ref...

Page 107: ... mm Incision 1 Double distance from the center to where the first cut will be performed Diameter mm Incision 2 Double distance from the center to where the second cut will be performed Pachymetry µm Incision 1 Thinnest pachymetry measured at the site of incision 1 Pachymetry µm Incision 2 Thinnest pachymetry measured at the site of incision 2 Depth ratio Incision 1 Ratio of the incision 1 depth to...

Page 108: ...n degrees which determines the arc length To view or specify the common parameters click Common options Fig 68 Fig 69 Arcuate incisions Common options dialog box Common options parameters Parameter dialog box Definition Energy µJ Energy level of each single pulse of the rim cut Side cut angle Angle of the incision in respect to the corneal anterior surface Spot spacing µm Distance from spot to spo...

Page 109: ...1 Side port 1 and or the secon dary incision 2 Side port 2 Fig 71 Fig 71 Corneal incisions parameters dialog box Parameters Parameter dialog box Definition Primary Perform a primary corneal incision Outer width mm Primary Adjust the outer width of the primary incision according to the size of the selected IOL Inner width mm Primary Adjust the inner width of the primary incision according to the si...

Page 110: ...rd length Side port 2 Option to perform a secondary corneal incision 2 Outer width mm Side port 2 Adjust the outer width of the secondary incision 2 Inner width mm Side port 2 Adjust the inner width of the secondary incision 2 Axis Side port 2 Select the position of the secondary incision 2 This position may be changed according to the cyclorotation of the eye after the patient has been docked Cho...

Page 111: ...of the primary incision secondary incision 1 or secondary incision 2 ends Length µm Plane 2 Length of the second plane of the primary incision secondary inci sion 1 or secondary incision 2 o Three planes Depth µm Plane 3 Depth in which the final plane of the primary incision secondary incision 1 or secondary incision 2 ends Angle Plane 3 Cutting angle for the third plane of the primary incision se...

Page 112: ... of every single pulse creating the incision cut Spot spacing µm Distance from spot to spot on the line Line spacing µm Distance of the spots from line to line 8 5 4 1 Schematic overview on corneal incisions Common options dialog box Schematic view of planes 1 2 and 3 SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 46 ...

Page 113: ...Schematic view of the plane depths Schematic view of the side cut angles SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 47 ...

Page 114: ...ed to the epithelium sur face measured in µm Diameter mm The diameter of the flap is determined by the cutting circle of the bed and the rim meas ured in chord length Parameter dialog box Definition Energy µJ Energy level of each single pulse when cutting the bed Spot spacing µm Distance from spot to spot on the line Line spacing µm Distance of the spots from line to line Disable bed cut To disabl...

Page 115: ...dditional rim at the top To ensure that the rim is extended past the cornea it is best to use a positive value Parameter dialog box Definition Position Predefined position of the hinge Position Angle of the center of the hinge Size The length of the hinge width is measured as an angle or length in µm The size of the hinge length can be determined by the angle or the hinge width Rim dialog box Fig ...

Page 116: ...automatically Fig 80 Parameter dialog box Definition Diameter mm Diameter of the PKP at the anterior surface of the cornea Pachymetry µm Pachymetry of the thickest point of the cornea at the diameter of the PKP Depth ratio Ratio of cutting depth to pachymetry should be above 100 for PKP Resulting depth µm Cutting depth resulting from pachymetry and depth ratio Posterior diameter mm Diameter of the...

Page 117: ... the eye Arc length Arc length of rim cut normally 360 Arc center position Central position of rim cut in case it is not 360 Posterior diameter mm The diameter of the PKP at the posterior sur face of the cornea resulting from entered pachymetry diameter and side cut angle 8 5 7 Parameters for lamellar keratoplasty Precondition n A lamellar keratoplasty procedure must be selected Fig 83 For general...

Page 118: ...cutting the bed Line spacing µm Distance between spots of adjacent lines when cutting the bed Parameter dialog box Definition Energy µJ Energy level of each single pulse when cutting the rim Spot spacing µm Distance between adjacent spots on a line when cutting the rim Line spacing µm Distance between spots of adjacent lines when cutting the rim Side cut angle Angle between the corneal surface tan...

Page 119: ...cut angle 8 5 8 Parameters for crosslinking Precondition n A crosslinking procedure must be selected Fig 87 For general information about how to view or specify parameter values refer to Ä Chapter 8 5 1 Parameters for capsulotomy on page 8 36 Parameter specific information are described below Fig 87 Crosslinking dialog boxes Size parameter values Parameter dialog box Definition Depth µm Depth of b...

Page 120: ...pot spacing µm Distance between adjacent spots on a line when cutting the incisions Line spacing µm Distance between spots of adjacent lines when cutting the incisions Top bonus µm Extension of the incision cut at the anterior side of the cornea to ensure exit of laser cut out of the eye Bottom bonus µm Extension of the incision cut inside the cornea to ensure that incision and bed cut overlap Arc...

Page 121: ...nel 1 Central position of the tunnel 1 Pachymetry µm Tunnel 1 Pachymetry of the thinnest point of the cornea at the diameter of the ICRS Depth ratio Tunnel 1 Ratio of cutting depth to pachymetry Resulting depth µm Tunnel 1 Cutting depth resulting from pachymetry and depth ratio Energy µJ Tunnel 1 Energy level of each single pulse when cutting the tunnel Spot spacing µm Tunnel 1 Distance between ad...

Page 122: ...spots on a line when cutting the incisions Line spacing µm Distance between spots of adjacent lines when cutting the incisions Top bonus µm Extension of the incision cut at the anterior side of the cornea to ensure exit of laser cut out of the eye Bottom bonus µm Extension of the incision cut inside the cornea to ensure that incision and tunnel cut overlap Parameters that remain unchanged are not ...

Page 123: ...f incision 1 Position of incision 1 o Position of incision 2 Perform incision 2 deactivated by default Length of incision 2 µm Length of incision 2 deactivated by default Position of incision 2 Position of incision 2 deactivated by default Parameters that remain unchanged are not listed in the table below Fig 97 ICRS dialog boxes two tunnel segments Fig 95 Tunnel dialog box single tunnel segment F...

Page 124: ...egment 2 Position Tunnel 2 Central position of tunnel segment 2 Parameter Definition þ Position of incision 1 Perform incision 1 Length of incision 1 µm Length of incision 1 Position of incision 1 Position of incision 1 þ Position of incision 2 Perform incision 2 Length of incision 2 µm Length of incision 2 Position of incision 2 Position of incision 2 Fig 98 Tunnel dialog box two tunnel segments ...

Page 125: ... tunnel The length and position of the cuts are adjustable A sche matic view of an intrastromal tunnel dissection is shown The entry incision which is marked as the bold blue solid line is the only opening to the corneal sur face Schematic top view of an ICRS tunnel incision Schematic side view of an ICRS tunnel incision Schematic view of width and bottom bonus SOFTWARE 8 SKU 70005780TPV Version 6...

Page 126: ...Schematic side view of width and bottom bonus Overview on the incision axes for left and right eye SOFTWARE 8 SKU 70005780TPV Version 6 UM 100010770 GB 8 60 ...

Page 127: ...eshooting chart on page 10 1 9 1 Preparing the laser system for a treatment day 1 Disinfect the surgery environment 2 Switch on the laser system Ä Chapter 6 2 3 1 Switching the laser system on and off on page 6 4 While the laser system warms up you can proceed with the following tasks 3 Reference the patient bed Ä Chapter 6 2 11 1 Referencing the patient bed on page 6 12 4 Adjust the surgical micr...

Page 128: ...r Flap 160 kHz for flap procedures Fig 27 4 in the Main menu screen Perform the following tests Laser position test Depth test Power test 9 3 1 Chiller submenu 1 Click the System test button Fig 27 5 on the Main menu screen 2 Click the Chiller button Fig 45 1 to open the Chiller screen Fig 100 Chiller screen after chiller functionality test ð The Chiller screen Fig 100 opens The following informat...

Page 129: ...forming the laser position test If the Laser position test has been completed successfully it is valid for one treat ment or for 24 hours If you fail to execute a procedure within this time frame the Laser position test must be repeated 1 Click the System test button Fig 27 5 on the Main menu screen 2 Click the Laser position test button Fig 45 4 to open the Laser position test screen Fig 101 Fig ...

Page 130: ...ion reservoir If the Vacuum test has been performed successfully it is valid for 24 hours 1 Click the System test button Fig 27 5 on the Main menu screen 2 Click the Vacuum test button Fig 45 2 to open the Vacuum test screen Fig 103 Vacuum test Preparation screen 3 Follow the instructions in the Vacuum test screen Fig 102 Laser position test suc cessful TREATMENT 9 SKU 70005780TPV Version 6 UM 100...

Page 131: ... test Special tool n Digital scale n Round plate holder n Short adapter n Support block 1 Click the System test button Fig 27 5 on the Main menu screen 2 Click the Pressure test button Fig 45 3 to open the Pressure test screen Fig 105 Pressure test Preparation screen 3 Follow the instructions in the Pressure test screen Fig 104 Vacuum test successful TREATMENT 9 SKU 70005780TPV Version 6 UM 100010...

Page 132: ...Power test for cataract thera peutic and corneal treatments Special tool n Detector head n Power meter n Support block 1 Click the System test button Fig 27 5 on the Main menu screen 2 Click the Power test button Fig 45 5 to open the Power test screen Fig 107 Power test Preparation screen 3 Follow the instructions in the Power test screen Fig 106 Pressure test successful TREATMENT 9 SKU 70005780TP...

Page 133: ... Kit REF 90000115 or n Patient Interface 125 of the Patient Interface 125 Kit REF 90000145 You can use a PI 125 for up to five depth tests To use a PI 125 more than once choose a different diameter in the Diameter field for each depth test 1 Click the System test button Fig 27 5 on the Main menu screen 2 Click the Depth test button Fig 45 6 to open the Depth test screen Fig 109 Depth test Preparat...

Page 134: ...ironment Removing the suction clip from the package Opening the suction clip Placing the suction clip onto the patient s eye Verifying that the suction is actually engaged Docking the patient to the PI 125 Closing the suction clip Performing the treatment 1 Observe all hygiene regulations related to medical treatments 2 Select the patient you want to treat Ä Chapter 8 4 2 Selecting patients on pag...

Page 135: ... injury due to incorrect parameters If parameters are illogical and not within the recommended range the treat ment results may differ from the desired outcome which may cause severe patient injuries Always enter and verify all parameters very carefully For detailed information about the relevant procedure parameter values refer to the Addendum to the user manual VICTUS Femtosecond Laser Platform ...

Page 136: ...at the legs of the patient are not crossed The supplied leg bolster should always be used to reduce patient movement 3 Place the leg bolster under the patient s knees to improve patient comfort and discourage crossing of legs 4 Ask the patient to lay the arms alongside his body or fold them lightly clasped across the stomach 5 Use the molded headrest to securely and comfortably fixate the patient ...

Page 137: ...ourage crossing of legs 4 Ask the patient to lay the arms alongside his body or fold them lightly clasped across the stomach 5 Use the molded headrest to securely and comfortably fixate the patient s head 6 To secure the position of the patient and to minimize head movement during the procedure fasten the Velcro strapping Fig 114 1 across the forehead ð The patient is positioned on the patient bed...

Page 138: ...ing Inner packaging REF 90000115 Refer to the Patient Interface 125 Kit REF 90000145 instructions for use Outer packaging Inner packaging REF 90000145 Patient Interface 125 Kit REF 90000115 Patient Interface 125 Kit REF 90000145 TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 12 ...

Page 139: ...uction clip If neces sary dispose of the PI 125 Kit and use a different one The sterile person must not touch the packaging of the PI 125 Kit Before connecting the PI 125 to the spacer cone ensure that the contact sur face of the spacer cone is absolutely clean Clean the contact surface of the spacer cone if necessary Ä Cleaning the spacer cone on page 6 14 1 Inspect the PI 125 Kit packaging and d...

Page 140: ...ng the PI 125 Kit REF 90000115 Open the protective cover keep all components of the kit inside the blister Fig 115 1 and secure the inlay Fig 115 2 with your thumb 2 Hold the blister Fig 115 1 with the PI 125 REF 90000115 under the spacer cone so that the PI 125 REF 90000115 can be sucked to the spacer cone TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 14 ...

Page 141: ... the vacuum is in the valid range The PI 125 REF 90000115 must be properly connected to the spacer cone to prevent suction loss L WARNING Danger of injury due to contamination of the PI 125 REF 90000115 If the PI 125 REF 90000115 is contaminated during the docking process infection of the patient s eye may occur Do not open the PI 125 Kit REF 90000115 packaging until you are ready to use it Fig 11...

Page 142: ...ter so that the sterile person can remove the suction clip REF 90000115 L WARNING Infection hazard due to loss of sterility The following task must be performed by the sterile user only to ensure the sterility of the suction clip REF 90000115 7 Without touching the blister Fig 115 1 remove the suction clip REF 90000115 carefully Inspect it for any visible damage or contamination n If the suction c...

Page 143: ...tion enabled example ð The suction reservoir and the suction port must be properly connected to prevent suction loss If a suction loss has occurred the Eye suction status indicator turns gray The procedure s cannot be performed 11 If a suction loss has occurred check the connection between the suction port and the suction reservoir Adjust the connection if necessary and repeat steps 5 to 10 12 To ...

Page 144: ...le person only Fig 123 PI 125 Kit REF 90000145 blister packs 1 Split the blister packs Fig 123 of the PI 125 Kit REF 90000145 into two parts at the perforation line Fig 123 3 2 Open the protective cover of the PI 125 blister pack containing the PI 125 REF 90000145 Fig 123 1 3 Keep the PI 125 REF 90000145 inside the PI 125 blister pack 4 Without touching the PI 125 REF 90000145 hold the PI 125 blis...

Page 145: ... the vacuum is in the valid range The PI 125 REF 90000145 must be properly connected to the spacer cone to prevent suction loss L WARNING Danger of injury due to contamination of the PI 125 REF 90000145 If the PI 125 REF 90000145 is contaminated during the docking process infection of the patient s eye may occur Do not open the PI 125 Kit REF 90000145 packaging until you are ready to use it Fig 12...

Page 146: ...at step 6 7 Open the protective cover of the suction clip blister pack containing the suction clip REF 90000145 Fig 123 2 8 Keep all components inside the suction clip blister pack 9 Hold the suction clip blister pack Fig 123 2 so that the sterile person can remove the suction clip REF 90000145 PI recognition does not work TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 20 ...

Page 147: ...tamination n If the suction clip REF 90000145 is damaged in any way dispose of the suction clip REF 90000145 and use a different one L WARNING Infection hazard due to loss of sterility The following task must be performed by the sterile user only to ensure the sterility of the suction clip REF 90000145 11 If the suction clip REF 90000145 is not open open it by pulling the snap fit Fig 129 backward...

Page 148: ...curred check the connection between the suction port and the suction reservoir Adjust the connection if necessary and repeat steps 10 to 13 15 To verify that the suction is actually engaged gently lift the suction clip REF 90000145 16 Press the release button at the patient bed and wait 3 seconds for the lock to disengage swing the patient bed completely in under the laser system and wait 3 second...

Page 149: ...10 Fig 12 1 Align the reflection of the laser ring light on the cornea with the laser ring light and gently move the patient bed upward 5 Slowly move the patient bed upward until the central cornea gently touches the PI 125 Ensure that there are no wrinkles visible in the OCT image L CAUTION Ensure that the pressure status display does not reach the upper red pressure display area Otherwise there ...

Page 150: ...ot correct the pressure by using the joystick Fig 132 1 or Fig 133 1 until one LED is illuminated green or yellow 11 Close the suction clip by pressing the ends of the suction clip together ð The patient is docked to the PI 125 12 If the pressure status display does not turn green move the patient bed until you reach the green pressure status display area Ensure that there are no wrinkles visible ...

Page 151: ... that there are no wrinkles visible in the OCT image L CAUTION Ensure that the pressure status display does not reach the upper red pressure display area Otherwise there is a higher risk to have wrinkles in the posterior cornea ð The shear force display shows the lateral pressure that is exerted on the eye The optimal position is achieved when the LEDs are illuminated green 6 Check if there are ai...

Page 152: ...force LEDs on the force display is still illuminated 14 If the docking was performed correctly a thin fluid film is visible in the periphery between the cornea and the PI 125 and the cornea preserves its natural shape 9 4 4 3 For all other procedures using a headrest with integrated joy stick 1 Move the patient bed using the joystick Fig 132 1 or Fig 133 1 of the patient bed control at the headres...

Page 153: ...re central green or yellow shear force LEDs on the force display is illuminated n If not correct the pressure by using the joystick Fig 132 1 or Fig 133 1 until one LED is illuminated green or yellow 10 Close the suction clip by pressing the ends of the suction clip together ð The patient is docked to the PI 125 11 Verify again that one of the more central green or yellow shear force LEDs on the f...

Page 154: ...ring between the PI 125 and the cornea n If there is a water ring undock the patient and use a Merocel sponge to absorb excess fluids Repeat steps 1 to 7 8 Verify that the eye is correctly centered 9 Verify that one of the more central green or yellow shear force LEDs on the force display is illuminated n If not correct the pressure by using the X Y joystick for the shear force and the Z joystick ...

Page 155: ...rom the spacer cone carefully by clicking the blue button next to the PI suction status indicator ð The PI suction status indicator turns gray 6 Remove the suction reservoir from the suction port 7 L WARNING Infection hazard due to reuse of the PI 125 and suction clip The PI 125 and the suction clip are single use devices They must not be refurbished or reused Neglecting this rule may result in in...

Page 156: ...eatment via the video live image in order to detect potential problems Note that an incomplete bubble pattern during a capsulotomy procedure may indicate an incomplete capsulotomy 1 Position the patient on the patient bed Ä Chapter 9 4 2 Positioning the patient on the patient bed on page 9 9 2 Connect the PI 125 to the spacer cone Ä Chapter 9 4 3 Connecting the PI 125 to the spacer cone and positi...

Page 157: ... Fig 135 The automatic identifica tion of ocular structures is performed Fig 136 LRCS Treatment alignment lens screen ð The yellow marking circle appears in the video camera image Fig 136 The pupil margin is determined The yellow marking outlines appear in the linear scan images Fig 136 The lens margins are determined The capsulotomy appears in the linear scan images and in the ring scan image Fig...

Page 158: ... If you agree with the results of the automatic identification of ocular struc tures click the Confirm button Fig 136 and continue with step 23 TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 32 ...

Page 159: ...case the limbus centering is different to the pupil centering the capsulotomy center will be shifted towards the center defined by the limbus marking In any case the pupil margin including the minimum safety distance of 500 µm will be respected n To determine the limbus margin click the Mark limbus button Fig 136 and mark three points on the limbus in the video camera image n To center to the lens...

Page 160: ...ge Fig 138 The limbus margin is determined If the limbus margin is not in the right position repeat the relevant part in step 3 Fig 139 Centering to the lens apex example The capsulotomy is centered to the lens apex in the video camera image Fig 139 4 Check the lens fragmentation pattern regarding the number of respective cuts TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 34 ...

Page 161: ...tton in the Linear scan 0 OCT B scan image Fig 137 Fig 140 Lens structures 0 6 Click the button Fig 140 To mark the anterior lens 0 position mark the anterior capsule of the lens with three points 7 Click the button Fig 140 To mark the posterior lens 0 position mark the posterior capsule of the lens with three points Fig 141 Lens margins are determined in 0 position TREATMENT 9 SKU 70005780TPV Ver...

Page 162: ... both the Linear scan 0 and Linear scan 90 OCT B scan images if the positions have been marked in both images If the positions have been marked in only one image they are indicated by the green marking dots the yellow outline is not displayed 10 Click the Mark capsulotomy button in the ring scan OCT B scan image Fig 137 if it is necessary to correct the capsulotomy Mark the highest point and the l...

Page 163: ... image and the out lines in the linear scan images turn green The Start button becomes available Fig 143 L WARNING Risk of tissue bridges due to movement when laser is firing Tissue bridges may occur if vibrations from movement occur when the laser is firing Do not walk around while the procedure is performed Do not touch the patient bed or the patient s head while the procedure is performed Do no...

Page 164: ...otomy progress bar Fig 144 L WARNING Risk of tissue bridges due to correction of vertical shear force movement The vertical force may change or the applied shear force may change during the procedure If you attempt to correct such changes this may affect the alignment or the treatment result which may cause severe patient injuries Do not correct changing vertical force or shear force during the pr...

Page 165: ...ng the suction clip on page 9 28 Fig 145 Regular docking of the patient 15 After the suction clip has been closed and the parameter setting has been approved by clicking the Approve button Fig 145 the Start button becomes available Fig 146 Fig 146 Treatment screen before starting the arcuate incisions procedure 16 If you agree with the parameter setting continue with step 20 TREATMENT 9 SKU 700057...

Page 166: ...e in the center in the video camera image To compensate for cyclotorsion click on Fig 147 to turn the posi tions counterclockwise or on Fig 147 to turn the positions clock wise The cyclotorsion is displayed in degrees in the video camera image The center point of the arcuate incisions Fig 147 and the corneal incisions Fig 147 can be moved by dragging and dropping of the dot which represents the ce...

Page 167: ...gth of the arcuate incisions cut To change the pachymetry value to the patient s actual pachymetry left click on the yellow dot Fig 148 and drag and drop it to the rear side of the cornea Fig 149 Changing the pachymetry value ð The Pachymetry µm value changes Simultaneously the Resulting depth µm value changes based on the preset Depth ratio per centage TREATMENT 9 SKU 70005780TPV Version 6 UM 100...

Page 168: ...cedure footswitch the treatment will pause Press the footswitch again to continue the treatment ð An acoustic signal is emitted during the procedures The progress is displayed in the Arcuate incisions progress bar 23 After the arcuate incisions procedure is finished the corneal incisions pro cedure starts automatically The progress is displayed in the Corneal incisions progress bar 24 When the com...

Page 169: ...is activated and the patient is docked 26 Do not remove the suction clip while the vacuum is activated 27 Verify that the eye suction has been released after the procedure has been executed ð The Eye suction status indicator of the suction clip turns gray If a treatment is completed and the Eye suction status indicator does not turn gray you must manually pull off the suction reservoir from the su...

Page 170: ...pupil recognition is performed Fig 152 LRCS Treatment alignment lens screen ð The yellow marking circle appears in the video camera image Fig 152 The pupil margin is determined 2 If you agree with the result of the pupil recognition continue with step 5 TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 44 ...

Page 171: ...l be shifted towards the center defined by the limbus marking In any case the pupil margin including the minimum safety distance of 500 µm will be respected n To determine the limbus margin click the Mark limbus button Fig 152 and mark three points on the limbus in the video camera image Note that centering to the lens apex is only possible once the marking of the anterior and the posterior lens s...

Page 172: ...ge Fig 154 The limbus margin is determined If the limbus margin is not in the right position repeat the relevant part in step 3 Fig 155 Centering to the lens apex example The capsulotomy is centered to the lens apex in the video camera image Fig 155 4 Check the lens fragmentation pattern regarding the number of respective cuts TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 46 ...

Page 173: ...ning is performed ð The green marking line representing the selected surface appears in the OCT B scan image The frame around the button is highlighted green Fig 156 If the anterior lens 0 is not in the right position click once again on the button Mark the anterior lens 0 position as described to find the right position TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 47 ...

Page 174: ...oning is performed ð The green marking line representing the selected surface appears in the OCT B scan image The frame around the button is highlighted green Fig 157 If the posterior lens 0 is not in the right position click once again on the button Mark the posterior lens 0 position as described to find the right position TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 48 ...

Page 175: ...ning is performed ð The green marking line representing the selected surface appears in the OCT B scan image The frame around the button is highlighted green Fig 158 If the anterior lens 90 is not in the right position click once again on the button Mark the anterior lens 90 position as described to find the right position TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 49 ...

Page 176: ...face appears in the OCT B scan image The frame around the button is highlighted green Fig 159 If the posterior lens 90 is not in the right position click once again on the button Mark the posterior lens 90 position as described to find the right position 9 To activate the capsulotomy setting click the button next to the OCT B scan image Fig 159 Fig 160 Capsulotomy in the ring scan OCT B scan image...

Page 177: ... Kit REF 90000115 or n Suction Clip 125 of the Patient Interface 125 Kit REF 90000145 The surgeon must observe the treatment via the video live image in order to recognize possible problems 1 Perform steps 1 to 6 in Ä Chapter 9 5 Performing a cataract treatment on page 9 30 2 Verify that the PI suction status indicator the Eye suction status indi cator and the pressure status display are all green...

Page 178: ...sed on an automatical pupil detection or click within the red highlighted circle and shift it by dragging and dropping in the right position to center the orange marking circle manually Fig 162 Centering is performed ð The flap is correctly positioned Fig 162 L WARNING Risk of rough beds or tissue bridges due to move ment when laser is firing Rough beds or tissue bridges may occur if vibrations fr...

Page 179: ... treatment will pause Press the footswitch again to continue the treatment ð An acoustic signal is emitted during the procedure The progress is displayed in the Flap progress bar Fig 164 L WARNING Rough beds or tissue bridges can occur due to cor recting vertical shear force movement Vertical force may slowly decrease or the executed shear force may change while the procedure is being performed If...

Page 180: ...patient bed leads to an abrupt loss of vacuum and causes pain to the patient Do not lower the patient bed while the vacuum is activated and the patient is docked 10 Do not remove the suction clip while the vacuum is activated 11 Verify that the eye suction has been released after the procedure has been executed ð The Eye suction status indicator of the suction clip turns gray If a treatment is com...

Page 181: ...ming of a lamellar keratoplasty procedure a crosslinking procedure or an ICRS tunnel procedure is similiar to the penetrating keratoplasty procedure except the differences in the respective procedures that are described in detail The surgeon must observe the treatment via the video live image in order to detect potential problems 1 Perform steps 1 to 6 in Ä Chapter 9 5 Performing a cataract treatm...

Page 182: ...ck the pachymetry marking yellow line in the OCT B scan image Fig 166 Change it if necessary For penetrating keratoplasty procedures The yellow line should be below the lowest point of the cornea for PKP only For lamellar keratoplasty procedures crosslinking procedures or ICRS tunnel procedures The yellow line should be above the thinnest point of the cornea 5 If you agree with the results of the ...

Page 183: ...reen marking circle appears in the video camera image Fig 167 The pupil margin is determined If the pupil margin is not in the right position repeat step 6 7 Before starting the procedure the user must verify that the parameter values are correct Check the parameter values in the Parameters dialog box Fig 167 Change it if necessary TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 57 ...

Page 184: ...switch must be pressed from the start of the procedure until the end of the procedure If you release the Procedure footswitch the treatment will pause Press the footswitch again to continue the treatment ð An acoustic signal is emitted during the procedure The progress is displayed in the Penetrating keratoplasty progress bar Fig 168 L WARNING Risk of tissue bridges due to correction of vertical s...

Page 185: ...ng the patient bed leads to an abrupt loss of vacuum and causes pain to the patient Do not lower the patient bed while the vacuum is activated and the patient is docked 11 Do not remove the suction clip while the vacuum is activated 12 Verify that the eye suction has been released after the procedure has been executed ð The Eye suction status indicator of the suction clip turns gray When a treatme...

Page 186: ...TREATMENT 9 SKU 70005780TPV Version 6 UM 100010770 GB 9 60 ...

Page 187: ...Stop button is acti vated n Ensure that the cause of the laser stop has been removed before unlocking the Laser Stop button Assistant User Authorized Service Tech nician Reset button is illuminated blue n Press the blue Reset button until it is not illuminated any more Assistant User Patient bed has not been ref erenced n Reference the patient bed Assistant User Laser system is not ready for opera...

Page 188: ...ser system Emergency shut down has been initiated auto matically by fail ures n If an emergency shutdown occurs during a treatment make sure the eye suction is automatically switched off Otherwise switch it off Lower the patient bed and swing it in the patient entry posi tion Refer to the user manual Laser Patient Bed LS Comfort or Patient Support System PSS S60 by AKRUS GmbH Co KG n Ask the patie...

Page 189: ...echnician Fault description Cause Remedy Personnel Supply temperature and or Current flow are not in the specified range Room temperature and or current flow are out side of the specified range n Shut down the laser system and try to restart it n If the problem persists contact an Authorized Service Techni cian Assistant User Authorized Service Techni cian Fault description Cause Remedy Personnel ...

Page 190: ... blurred Focus of oculars is not adjusted n Adjust focus of the oculars Assistant User All other causes n Contact an Authorized Service Technician Authorized Service Technician Fault description Cause Remedy Personnel In the Licenses screen opens the message Key is for another laser The wrong user key has been inserted n Insert the correct user key Assistant User Surgical microscope User key TROUB...

Page 191: ...11 Technical data 11 1 General specifications Fig 169 Dimensions of the laser system top view with patient bed LS Comfort TECHNICAL DATA 11 SKU 70005780TPV Version 6 UM 100010770 GB 11 1 ...

Page 192: ...g 170 Dimensions of the laser system top view with patient bed Patient Support System S60 Fig 171 Dimensions of the laser system side view TECHNICAL DATA 11 SKU 70005780TPV Version 6 UM 100010770 GB 11 2 ...

Page 193: ...lic liquids Floor loading minimum 0 9 kg cm2 The room temperature has to be kept stable with a maximum change of 1 C per hour Therefore active air conditioning is required The lighting of the operating room must comply with lighting standards for oper ating rooms Data Value Unit Maximum operating time without shutdown of the laser system If operating con ditions are within the previ ously specifie...

Page 194: ...tform 11 4 Transport and storage conditions n Store the laser system in a dry and dust free location n Protect the laser system from direct sunlight n Avoid mechanical vibration Data Value Unit Ambient temperature 5 50 C Relative humidity maximum non condensing 10 95 Air pressure 800 1060 hPa 11 5 Electrical connection Data Value Unit Input voltage 230 V AC Frequency 50 60 Hz Power input maximum 1...

Page 195: ...0 Cataract treatment with 2S OCT performing 9 31 Cataract treatment with TD OCT performing 9 44 Cleaning assistant workstation 6 14 laser system 6 13 overview 6 13 patient bed 6 14 spacer cone 6 14 surgeon control screen 6 14 surgical microscope 6 14 Closing software 8 5 Commissioning 4 1 Completing a treatment 9 29 Complications 2 1 Components overview 6 1 Cone 6 7 Cone protection 6 8 Contraindic...

Page 196: ...ration 13 3 Error messages 10 1 Essential performance 11 4 Explanation of symbols A 1 Exporting treatment records 8 34 F Faults 10 1 Flap contraindications 5 3 description 5 4 parameters 8 48 Flap procedure performing 9 51 Footswitches Procedure footswitch 6 11 Vacuum footswitch 6 11 Force display 6 6 G General hazards 2 5 General specifications 11 1 H Hardware overview 6 1 I ICRS tunnel parameter...

Page 197: ...nt 9 1 P Parameters arcuate incisions 8 40 capsulotomy 8 36 corneal incisions 8 43 crosslinking 8 53 flap 8 48 ICRS tunnel 8 54 lamellar keratoplasty 8 51 lens fragmentation 8 37 penetrating keratoplasty 8 50 Patient administration 8 23 Patient bed 6 12 interface description 4 2 positioning the patient 9 9 referencing 6 12 Patient data deleting 8 26 Patient Interface 125 connecting 9 11 Patients a...

Page 198: ...electing patients 8 25 treatments 8 27 Selecting patients contraindications 5 2 Service 4 3 Settings 8 17 checking 8 17 modifying 8 17 Shifting the camera focus 6 7 Side effects 2 1 Signals acoustic 2 9 visual 2 9 Signs 2 11 in the entrance area 2 12 on the laser system 2 13 Soft docking screen 8 11 Software closing 8 5 elements 8 5 log in 8 4 operating 8 1 starting 8 1 working with 8 1 Spacer con...

Page 199: ... 31 cataract with TD OCT performing 9 44 completing 9 29 corneal creating 8 28 corneal performing 9 51 corneal incisions performing 9 30 crosslinking performing 9 55 flap performing 9 51 ICRS tunnel performing 9 55 lamellar keratoplasty performing 9 55 lens fragmentation performing 9 30 LRCS creating 8 28 LRCS performing 9 30 overview 9 1 penetrating keratoplasty performing 9 55 preparing 9 1 ther...

Page 200: ...al microscope 10 4 user key 10 4 U Use 2 1 User profiles 8 19 rights 8 19 User Ophthalmologist 2 4 Users adding 8 20 editing 8 21 V Vacuum controller adjusting 6 5 description 6 5 Vacuum test 9 4 VICTUS Femtosecond Laser Platform overview 1 1 Viewing treatment records 8 34 W Warning messages 10 1 WEEE directive 2 18 INDEX 12 SKU 70005780TPV Version 6 UM 100010770 GB 12 6 ...

Page 201: ...Appendix 13 SKU 70005780TPV Version 6 UM 100010770 GB 13 1 ...

Page 202: ...Table of contents A EMC declaration APPENDIX 13 SKU 70005780TPV Version 6 UM 100010770 GB 13 2 ...

Page 203: ...Femtosecond Laser Platform is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes under the provision that the fol lowing warning is observed Warning This device system is solely intended for use by healthcare professionals This is a class A device system in accorda...

Page 204: ...V common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in...

Page 205: ...ated from the equation applicable to the frequency of the transmitter Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Veff 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Veff 10 V m Recommended separation distance d 1 2ÖP conducted d 1 2ÖP 80 MHz to 800 MHz radi ated d 2 3ÖP 800 MHz to 2 5 GHz radi ated P is the maximum output power rating of the transmitter in watts W according to the transmi...

Page 206: ...stance re orienting or relocating the VICTUS Femtosecond Laser Platform b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the VICTUS Femtosecond Laser Platform The VICTUS Femtosecond Laser Platform is intended for use in an electro magnetic environment in which radiat...

Page 207: ...ing the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and peop...

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