Technolas Victus Manuel utilisateur

User Manual

VICTUS™ Femtosecond Laser Platform, SW V3.3 SP02

UM-100010770 GB

SKU: 70005780TPV

Version 6

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

UM-100010770 / Version 6 / Page 1 of 207

Publishing details

User Manual

Version 6

[VICTUS SW V3.3 SP02; PI 125 Kit (REF 90000115) or PI 125 Kit (REF 90000145)]

Manufacturer

Technolas Perfect Vision GmbH

Messerschmittstr. 1 + 3

80992 München

Germany

www.TechnolasPV.com

For Customer Service or Technical Support:

Contact your local Customer Service or Technical Support.

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 products described herein in accordance with

the contractual terms for such product.

Subject to technical changes.

Document no. UM-100010770 GB

Edition: 2017-06-12

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

UM-100010770 / Version 6 / Page 2 of 207

A General information

A.1 Information about this user manual......................................................................................... A - 1

A.2 Explanation of symbols................................................................................................................... A - 1

A.3 Customer service................................................................................................................................ A - 2

A.4 Product names used in this user manual................................................................................ A - 3

A.5 Reference documents to this user manual............................................................................. A - 3

1 Introduction

1.1 VICTUS™ Femtosecond Laser Platform.................................................................................... 1 - 1

1.2 Scope of delivery................................................................................................................................. 1 - 1

1.3 Use with other medical devices.................................................................................................... 1 - 2

1.4 List of 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 - 8

2.7.5 Damage to property............................................................................................................................. 2 - 8

2.8 Warning signals and alarms........................................................................................................... 2 - 9

2.9 Safety devices....................................................................................................................................... 2 - 9

TABLE OF CONTENTS

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2.10 Labeling................................................................................................................................................ 2 - 11

2.10.1 Labels in the operating room entrance area............................................................................. 2 - 12

2.10.2 Labels on the laser system............................................................................................................... 2 - 13

3 Transport and storage

3.1 Transportation..................................................................................................................................... 3 - 1

3.2 Visual inspection after delivery................................................................................................... 3 - 1

3.3 Storage before installation............................................................................................................ 3 - 2

3.4 Unpacking............................................................................................................................................... 3 - 2

4Installation, commissioning, service, calibration,

decomissioning and disposal

4.1 Installation and comissioning....................................................................................................... 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 procedures...................................................................................................................... 5 - 4

6 Hardware

6.1 Overview on the components....................................................................................................... 6 - 1

6.2 Operating the hardware.................................................................................................................. 6 - 2

6.2.1 Main unit................................................................................................................................................... 6 - 2

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6.2.2 Assistant workstation / surgeon control screen......................................................................... 6 - 3

6.2.2.1 Adjusting the monitor settings......................................................................................................... 6 - 3

6.2.3 Start-up panel.......................................................................................................................................... 6 - 4

6.2.3.1 Switching the laser system on and off........................................................................................... 6 - 4

6.2.4 Suction status controller..................................................................................................................... 6 - 5

6.2.4.1 Adjusting the suction status.............................................................................................................. 6 - 5

6.2.5 Force display............................................................................................................................................ 6 - 6

6.2.6 Laser ring light illumination switch................................................................................................. 6 - 6

6.2.6.1 Switching the laser ring light illumination on and off.............................................................. 6 - 7

6.2.7 Camera focus switch............................................................................................................................. 6 - 7

6.2.7.1 Adjusting the camera focus............................................................................................................... 6 - 7

6.2.8 Spacer cone.............................................................................................................................................. 6 - 7

6.2.8.1 Protecting the spacer cone................................................................................................................ 6 - 8

6.2.9 Surgical 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’ screen............................................................................................. 8 - 5

8.1.3 Elements of the treatment screens.................................................................................................. 8 - 6

8.1.3.1 Treatment-specific elements........................................................................................................... 8 - 11

8.1.4 Checking and modifying common settings.............................................................................. 8 - 17

8.1.5 Checking treatment licenses........................................................................................................... 8 - 18

8.1.6 Restarting the software after an emergency shutdown....................................................... 8 - 18

8.2 User administration........................................................................................................................ 8 - 19

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8.2.1 User profiles and specific rights..................................................................................................... 8 - 19

8.2.2 Adding users......................................................................................................................................... 8 - 20

8.2.3 Editing registered user accounts................................................................................................... 8 - 21

8.3 System test description................................................................................................................. 8 - 21

8.4 Patient / treatment administration......................................................................................... 8 - 23

8.4.1 Adding patients................................................................................................................................... 8 - 24

8.4.2 Selecting patients................................................................................................................................ 8 - 25

8.4.3 Editing patient data............................................................................................................................ 8 - 26

8.4.4 Deleting patient data......................................................................................................................... 8 - 26

8.4.5 Selecting treatments for execution.............................................................................................. 8 - 27

8.4.6 Creating treatments........................................................................................................................... 8 - 28

8.4.6.1 Creating treatments based on default values........................................................................... 8 - 30

8.4.6.2 Creating treatments based on a template................................................................................. 8 - 31

8.4.7 Editing treatments.............................................................................................................................. 8 - 32

8.4.8 Deleting treatments........................................................................................................................... 8 - 32

8.4.9 Deleting treatment templates........................................................................................................ 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 lamellar keratoplasty........................................................................................... 8 - 51

8.5.8 Parameters for crosslinking............................................................................................................. 8 - 53

8.5.9 Parameters for ICRS tunnel.............................................................................................................. 8 - 54

8.5.9.1 Schematic overview on ICRS tunnel incisions........................................................................... 8 - 59

9 Treatment

9.1 Preparing the laser system for a treatment day.................................................................. 9 - 1

9.2 Maintaining the laser system after a treatment day......................................................... 9 - 1

9.3 Performing the daily system test................................................................................................ 9 - 2

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9.3.1 Chiller submenu..................................................................................................................................... 9 - 2

9.3.2 Performing the laser position test................................................................................................... 9 - 3

9.3.3 Performing the vacuum test.............................................................................................................. 9 - 4

9.3.4 Performing the pressure test............................................................................................................. 9 - 5

9.3.5 Performing the power test................................................................................................................. 9 - 6

9.3.6 Performing the depth test.................................................................................................................. 9 - 7

9.4 Daily routine.......................................................................................................................................... 9 - 8

9.4.1 When performing a treatment.......................................................................................................... 9 - 8

9.4.2 Positioning the patient on the patient bed.................................................................................. 9 - 9

9.4.2.1 Using a headrest with integrated joystick.................................................................................. 9 - 10

9.4.2.2 Using a headrest with external joysticks..................................................................................... 9 - 11

9.4.3 Connecting the PI 125 to the spacer cone and positioning the suction clip................. 9 - 11

9.4.3.1 Connecting the PI 125 (REF 90000115) to the spacer cone and positioning the suction

clip (REF 90000115)............................................................................................................................. 9 - 13

9.4.3.2 Connecting the PI 125 (REF 90000145) to the spacer cone and positioning the suction

clip (REF 90000145)............................................................................................................................. 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 with external joysticks.................................... 9 - 27

9.4.5 Repositioning the suction clip........................................................................................................ 9 - 28

9.4.6 Completing a treatment................................................................................................................... 9 - 29

9.5 Performing a cataract treatment.............................................................................................. 9 - 30

9.5.1 Preparing a cataract treatment...................................................................................................... 9 - 30

9.5.2 Performing a cataract treatment supported by a 2S-OCT.................................................... 9 - 31

9.5.3 Performing a cataract treatment supported by a TD-OCT................................................... 9 - 44

9.6 Performing a corneal treatment............................................................................................... 9 - 51

9.6.1 Performing a flap procedure........................................................................................................... 9 - 51

9.7 Performing a therapeutic treatment...................................................................................... 9 - 55

10 Troubleshooting chart

11 Technical data

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11.1 General specifications.................................................................................................................... 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

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A General information

To order additional copies of this user manual:

If additional copies of this user manual are required, refer to the SKU number on the

cover page and contact your Authorized Technolas Perfect Vision Representative.

A.1 Information about this user manual

This user manual enables safe and efficient handling of the product, its accesso‐

ries and tools. It must be kept close to the product where it is permanently acces‐

sible to the personnel.

Before starting any treatments, the personnel must read the manual thoroughly

and understand its contents. Users must comply with all specified safety instruc‐

tions and operating instructions to ensure safe operation.

In addition, local accident prevention regulations and general safety instructions

must be observed in the area where the product is used.

The product images in this user manual are intended to provide a basic under‐

standing of the product and may differ from the actual design you have on site.

Screenshots were created using an exemplary patient and exemplary values.

Depending on 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 symbols and a signal word

that describe the severity of the hazard.

Follow these safety notes and proceed with caution to avoid accidents, personal

injury, damage to property, and to ensure patient safety.

This symbol and the word "DANGER" indicate an imminent hazardous situa‐

tion that, if not avoided, could cause death or serious injury.

This symbol and the word "WARNING" indicate a possible hazardous situa‐

tion that, if not avoided, could cause death or serious injury.

This symbol and the word "CAUTION" indicate a possible hazardous situa‐

tion that, if not avoided, could result in minor or moderate injury.

This symbol and the word "NOTICE" indicate a possible hazardous situation

that, if not avoided, could result in damage to property or the environment.

Safety notes

LDANGER

LWARNING

LCAUTION

NOTICE

GENERAL INFORMATION A

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This symbol emphasizes useful tips and recommendations as well as information for

the efficient and trouble-free use of the product.

This field shows examples of previous instructions or information.Example of ...

Safety notes are included in step-by-step instructions. This format allows the user

to be aware of safety issues while performing tasks. The safety symbols are also

part of the step-by-step instructions.

The following symbols and markings are used in this manual to indicate guide‐

lines, descriptions of results, lists, and references:

Symbol Indicates

Step-by-step instructions

ðCondition or automatic 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

èUser Registry’

Menu path

A.3 Customer service

Our customer service division is available to provide technical support and infor‐

mation. If any questions arise that are not answered in this user manual, do not

hesitate to contact your Authorized Technolas Perfect Vision Representative for

assistance.

Hints, recommendations,

and examples

Safety notes in step-by-step

instructions

Symbols in this user manual

GENERAL INFORMATION

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A - 2

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