EVA NEXUS Ophthamic Surgical System Instruction Manual Ver B

Instruction Manual Ophthalmic Surgical System Foreword

Foreword D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. (further named as D.O.R.C. International) has developed an Ophthalmic Surgical System to be used in anterior and posterior segment surgical procedure. This document is part of the Ophthalmic Surgical System. Keep this Instruction Manual in the close vicinity of the Ophthalmic Surgical System! If the Instruction Manual is lost, order a new copy from D.O.R.C. International. The scope of this Instruction Manual is limited to the required information of the Ophthalmic Surgical System and its controls and is not intended to be a guide for the treatment of disorders where an ophthalmic surgery is indicated. Installation, repair and maintenance on the Ophthalmic Surgical System must be carried out only by a D.O.R.C. Representative. The D.O.R.C. Representative should be trained and qualified by D.O.R.C. International. Instructions for repair and/or maintenance can be found in the service manual. Equipment may only be opened and repaired by a trained and qualified D.O.R.C. Representative. Read this Instruction Manual carefully before first use of the Ophthalmic Surgical System.

Objective and target group of this document This Instruction Manual is intended to provide the surgeon and the surgical assistant with information concerning the use and the maintenance of the Ophthalmic Surgical System. We have organized this Instruction Manual in such a way that following the chapters will give you a complete understanding of the Ophthalmic Surgical System and ensure that you are able to use the system in a safe manner. Throughout this Instruction Manual you will find visual explanations describing the functions and screens of the Ophthalmic Surgical System. With these you are able to comprehend the use of the system quickly. Chapter 1 describes the intended use and general information. Chapter 2 covers important information on warnings and laser safety. Chapter 3 describes general information on the unpacking and installation. Be sure to read Chapter 4 & Chapter 5 to become familiar with the functions, connections and operating devices of the Ophthalmic Surgical System. Chapter 6 contains information on how to program the system. Chapter 7 - Chapter 8 provide information about each function and feature during use, how to set up the function and its associated disposables, and how to interact with each function.

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Instruction Manual Ophthalmic Surgical System Foreword

Chapter 9 through Chapter 12 contains information that you may occasionally need, such as meanings of system messages, maintenance, service information, and EMC specifications. These chapters are meant to serve as a reference to questions of a more technical nature. This Instruction Manual gives a lot of information about the handling of the Ophthalmic Surgical System but does not cover all possible situations. Therefore, if in doubt, please contact D.O.R.C. International. Make sure that you read and follow all safety precautions set forth in this manual. Information presented in this manual relating to surgical procedures is a suggestion only, and does not constitute any warranty of fitness or claim of responsibility, or undertaking of liability resulting from any surgical techniques practiced. The surgeon is ultimately responsible for determining the appropriate procedure for each patient.

Copyright Copyright © 2020 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or published in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior written permission of D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Symbols in this document Below, the symbols used in this document are explained. These symbols are used to alert the reader to specific warnings. Warning!

Signal word used to indicate a potentially hazardous situation which, if not avoided, could result in death or serious injury. Caution!

Signal word used to indicate a potentially hazardous situation which, if not avoided, could result in minor or moderate injury. Tip or suggestion.

Information to read carefully.

Indication for sterile actions.

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Instruction Manual Ophthalmic Surgical System Foreword

Original Instructions The instruction manual in the English language is considered the original instructions. Instruction manuals in other languages are not considered the original instructions, but translations of the original instructions.

Document history Date 2020-07-09

2021-03-03

Version A

B

Author

Status

Gert Zwart

Final

Gert Zwart

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Final

Comments Update to EVA NEXUSTM Specifications (Appendix 1: A1.5, A1.9, A1.10, A1.12). List of Instruments and Accessories (Appendix 2) replaced by a reference to a separate document. Update to Default Settings (Appendix 3). List of warning and safety notices (Appendix 4) removed. Changes due to software updates. Addition of two Laser warnings (chapter 3.5.2). Addition of an I/A instruments caution (chapter 8.9.1). Update to maintenance warning (chapter 10.3). Update term "eIOP" to "Smart IOP". Update to the diathermy and illumination icons. Update to system messages list (chapter 9)

Instruction Manual Ophthalmic Surgical System Contents

Contents Foreword... 2 Objective and target group of this document... 2 Symbols in this document... 3 Original Instructions... 4 Document history... 4

Contents... 5 1

Introduction...12 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

2

Intended Use... 12 Manufacturer... 13 Safety Standards... 13 Liability... 14 Guarantee... 14 Terminology... 15 Abbreviations... 16 Symbols... 17 1.8.1 Symbols used on the EVA NEXUSTM and in the Graphic User Interface... 19 1.8.2 Animations used for surgery steps... 25

Warning and Safety Notices... 26 2.1 2.2

General... 26 Safety instructions... 26 2.2.1 Transport... 26 2.2.2 Preparing for first use... 26 2.2.3 Electric shock hazard... 27 2.2.4 Fire and Explosion hazard... 27 2.2.5 Maintenance... 28 2.2.6 Handpieces and tips... 28 2.3 Warning and Cautions related to the optional Laser Module... 28 2.3.1 Preface... 28 2.3.2 Protection against unauthorized use... 29 2.3.3 Safety eye wear... 29 2.3.4 Electric protection... 29 2.3.5 Safeguard against unwanted Laser rays... 30

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2.3.6 2.3.7 2.3.8 2.3.9 2.3.10

3

NOHD... 30 Door interlock connection... 30 Safety shutter... 30 Manual reset... 31 Safety procedures... 31

Transportation / Unpacking / Installation... 32 3.1 3.2 3.3 3.4 3.5

Packing list... 32 Transporting... 32 Damage identified at delivery... 32 Unpacking... 32 Preparing for use... 33 3.5.1 Mounting the Mayo arm and tray and the bottle holder... 33 3.5.2 Requirements for the (Laser) treatment room... 33 3.5.3 Testing before use... 34 3.6 Initial Training... 35 3.7 Storage... 35 3.7.1 Moving... 36 3.7.2 Storage room... 36

4

Description...37 4.1 4.2 4.3 4.4 4.5

Configurations and Options... 37 Technical specifications... 37 Overview and main parts... 38 Labeling... 40 Operating devices... 42 4.5.1 Overview devices EVA NEXUSTM... 42 4.5.2 Footswitch EVA NEXUSTM... 44 4.5.3 Footswitch Laser... 46 4.6 Connections and buttons... 47 4.6.1 Main connection... 47 4.6.2 Front side... 48 4.6.3 Cartridge connections... 49 4.7 Instruments... 50 4.7.1 Phaco... 50 4.7.2 Vitrectome... 50 4.7.3 Diathermy... 50 4.7.4 Illumination... 50 4.7.5 VFI/VFE/MI... 50 4.7.6 Air... 51 4.7.7 Laser... 51 4.8 Applied parts... 51

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5

Placing and powering on... 52 5.1 5.2 5.3 5.4

6

Positioning the EVA NEXUSTM... 52 Connecting the EVA NEXUSTM... 53 Using the Mayo tray... 54 Switching the EVA NEXUSTM on (first time)... 55 5.4.1 Connecting Footswitch(es)... 55 5.4.2 Power on... 55

Programming...57 6.1 6.2 6.3

Introduction... 57 Main menu... 58 Programming: System Settings... 59 6.3.1 Hospital name... 59 6.3.2 Language... 59 6.3.3 Date/Time... 60 6.3.4 Laser filter... 60 6.3.5 Laser code... 60 6.3.6 User Settings pincode... 61 6.3.7 Units... 61 6.3.8 Visualization... 61 6.3.9 Leaving the system settings... 61 6.4 Programming User Settings (1): Basic surgeon setting... 62 6.4.1 Surgeon level (1): Selecting/Creating/Deleting/Renaming surgeons... 63 6.4.2 Surgeon level (2): Fluidics settings... 67 6.4.3 Surgeon level (3): Audio/Misc... 69 6.4.4 Surgeon level (4): Pedal settings Main Footswitch... 72 6.4.5 Surgeon level (5): Visualization... 75 6.4.6 Surgeon level (6): Exporting to- or Importing from a USB... 78 6.5 Programming User Settings (2): Programming Procedures... 84 6.5.1 Procedure level (1): Creating/Renaming/Deleting Procedure... 84 6.5.2 Procedure level (2): Copy procedures... 87 6.5.3 Starting programming... 89 6.5.4 Instrument selection... 90 6.5.5 Step manager... 91 6.5.6 Tab: Step settings... 95 6.5.7 Footswitch buttons... 97 6.5.8 Instrument settings... 99

7

Preparation for surgery... 100 7.1

Preparation for Priming... 101 7.1.1 Creating a sterile field... 101

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7.1.2 Selecting surgeon and procedure... 101 7.2 Priming screen... 102 7.3 Priming... 104 7.3.1 Placing Cartridge... 104 7.3.2 Connecting BSS container... 104 7.3.3 Confirming instruments for procedure... 106 7.3.4 Start filling cartridge... 107 7.3.5 Connecting tubing and instruments... 108 7.3.6 Start tubing filling... 112 7.4 Return to priming from surgery... 113 7.4.1 Re-priming from Phaco step... 114 7.4.2 Re-priming from Vitrectomy step... 115 7.5 Auxiliary priming functions... 116 7.5.1 Change BSS container... 116 7.5.2 Fill Cup... 117 7.5.3 Laser pincode... 118 7.5.4 Prime instruments... 119 7.5.5 Set patient eye level... 120 7.5.6 Release Cartridge... 121 7.5.7 Draining... 122

8

Surgery & Surgical functions...123 8.1 8.2

Priming prior to surgery... 123 Surgery screen and bottom bar... 123 8.2.1 Error indication... 124 8.2.2 Top bar... 124 8.2.3 Step selector Instrument menu... 125 8.2.4 Bottom bar... 126 8.2.5 Diathermy, Illumination and Air... 127 8.3 Footswitch buttons... 128 8.4 Anterior Procedure... 129 8.4.1 Phaco Emulsification... 129 8.4.2 Irrigation/Aspiration... 129 8.5 Posterior Procedure... 130 8.5.1 Infusion... 130 8.5.2 Vitrectomy... 130 8.5.3 Extrusion... 130 8.6 Combined Procedure (Phaco and Vitrectomy)... 131 8.7 Irrigation / Infusion... 132 8.7.1 Function... 132 8.7.2 Irrigation/infusion controls... 132 8.7.3 Irrigation/infusion modes... 133

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Instruction Manual Ophthalmic Surgical System Contents

8.7.4

Fluid alternate pressure... 136 8.8 Aspiration... 137 8.8.1 Function... 137 8.8.2 Aspiration controls... 137 8.8.3 Backflush... 138 8.8.4 Threshold modes... 141 8.8.5 Replacing Collection bag... 142 8.9 Irrigation / Aspiration... 143 8.9.1 Function... 143 8.9.2 Controls / Indicators... 143 8.9.3 Control interactions with other modules... 143 8.10 Extrusion mode... 144 8.10.1 Function... 144 8.10.2 Controls / Indicators... 144 8.10.3 Control interactions with other modules... 144 8.11 Phaco... 145 8.11.1 Function... 145 8.11.2 Preparation... 145 8.11.3 Controls / Indicators... 146 8.11.4 Explanation... 147 8.11.5 Explanation Phaco modes... 149 8.11.6 Clearing an occluded Phaco handpiece... 152 8.12 Vitrectomy... 153 8.12.1 Function... 153 8.12.2 Preparation... 153 8.12.3 Controls / Indicators... 153 8.12.4 Explanation of the pedal modes... 155 8.12.5 Control interactions with other modules... 157 8.13 Diathermy... 158 8.13.1 Function... 158 8.13.2 Preparation... 161 8.13.3 Controls / Indicators... 161 8.13.4 Diathermy as main function... 162 8.13.5 Direct Procedure: Diathermy... 163 8.14 Endoillumination... 164 8.14.1 Function... 164 8.14.2 Preparation... 164 8.14.3 Controls / Indicators... 165 8.14.4 Control interactions with other modules... 166 8.14.5 Spectral output... 166 8.15 Air... 170 8.15.1 Function... 170 8.15.2 Preparation... 170

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8.15.3 Controls / Indicators... 170 8.15.4 Explanation... 171 8.15.5 Control interactions with other modules... 171 8.16 VFI/VFE... 172 8.16.1 Function... 172 8.16.2 Preparation... 172 8.16.3 Controls / Indicators... 173 8.17 Micro Injection... 175 8.17.1 Function... 175 8.17.2 Preparation... 175 8.17.3 Controls / Indicators... 175 8.18 Anterior Vitrectomy... 176 8.19 Fragmentation... 176 8.20 Laser... 177 8.20.1 Function... 177 8.20.2 Controls / Indicators... 177 8.20.3 Footswitch use with Laser... 180 8.20.4 Emergency laser stop button... 181 8.21 Direct Procedure: Laser Indirect Ophthalmoscope... 182 8.22 Visualization... 182 8.23 Ending surgery... 183 8.23.1 Cartridge... 183 8.23.2 Disposal of disposables... 183 8.23.3 Reprocessing of reusables... 183 8.23.4 Switching the EVA NEXUSTM off... 183 8.23.5 Surgical Summaries... 183 8.23.6 Draining the cartridge... 184

9

System Messages...185 9.1 9.2

Methods to report an System message... 185 System Messages tables... 186

10 Maintenance... 203 10.1 Introduction... 203 10.2 Cleaning... 203 10.2.1 Cleaning and reprocessing of Reusable Instruments... 203 10.2.2 Cleaning and disinfecting the EVA NEXUSTM... 203 10.3 Preventive Maintenance... 204 10.3.1 Periodical instructions for preventive inspection / maintenance by the user... 204 10.3.2 Fuse replacement... 204 10.3.3 Replacing remote control batteries... 205

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11 Disposal after use... 206 12 Electromagnetic Compatibility (EMC)... 207 Appendix 1 Specifications...213 A1.1 A1.2 A1.3 A1.4 A1.5 A1.6 A1.7 A1.8 A1.9 A1.10 A1.11 A1.12 A1.13 A1.14 A1.15

EVA NEXUSTM Dimensions... 213 EVA NEXUSTM Environmental Specifications... 214 Footswitch... 215 EVA NEXUSTM Functions Specifications... 215 VacuFlow VTi... 216 Air module... 216 Vitrectomy module... 217 Endoillumination module... 217 Diathermy module... 217 Phaco Emulsification/Fragmentation module... 217 VFC module... 218 Laser Module... 218 Graphical User Interface... 219 Audio Feedback... 219 Remote control EVA NEXUSTM... 219

Appendix 2 Instruments and Accessories... 220 Appendix 3 Default Settings...221 Appendix 4 Quick Guide... 229 Index... 234

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Instruction Manual Ophthalmic Surgical System Chapter 1 - Introduction

1 Introduction 1.1 Intended Use The EVA NEXUSTM Ophthalmic Surgical System is intended for use in both anterior (i.e. Phaco-emulsification and removal of cataracts) and posterior segment (i.e. Vitreoretinal) ophthalmic surgeries. In addition, the optional laser is intended for the following use: Condition Diabetic Retinopathy •

Proliferative Diabetic Retinopathy

•

Clinically Significant Macular Edema

Retinal Tear and Detachments Lattice Degeneration Sub-retinal (choroidal) Neovascularization Retinal Vascular Occlusion •

Neovascularization secondary to Branch or Central retinal vein occlusion

•

Chronic macular edema secondary to Branch or Central retinal vein occlusion

Glaucoma •

Primary Open-angle

•

Closed Angle

Indications The EVA NEXUSTM is indicated for use on patients that require anterior segments (i.e. Phaco emulsification and removal of cataracts) and/or posterior segment (i.e. Vitreoretinal) ophthalmic surgery.

Contra-indications The EVA NEXUSTM does not have specific contra-indications for patients on the basis of age or weight or condition of the patient. It is the clinician’s responsibility to establish that the risks and benefit balance of any surgery are appropriate.

Users The EVA NEXUSTM may only be used by competent professionals (Qualified Healthcare Professionals or trained D.O.R.C. International representatives).

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Functions The following functions are included in the most advanced version of the system: Phacoemulsification, Vitrectomy, Diathermy, Illumination, Fluid/Air Exchange, Viscous Fluid Control, Micro Injection and Laser for Coagulation. NOTE: The EVA NEXUSTM system is designed to function with either compressed air or compressed nitrogen of the appropriate Medical Grade. The air used for Fluid / Air exchange procedures by the system is sourced from filtered ambient air. The EVA NEXUSTM system is equipped with an advanced Irrigation/Infusion and Aspiration system. The irrigation/infusion pump provides precise and fast pressure control. The aspiration pump makes it possible to control directly either the vacuum or the flow. A list of available accessories and instruments for the EVA NEXUSTM is provided in document 30339400. Warning! Use D.O.R.C. International approved instruments only.

1.2 Manufacturer Manufacturer D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Scheijdelveweg 2 3214 VN Zuidland The Netherlands Tel. :+31 (181) 45 8080 Fax :+31 (181) 45 8090 Please contact D.O.R.C. International if you have any questions or if you encounter any problems.

1.3 Safety Standards The Ophthalmic Surgical System is certified with respect to Electric Shock, Fire, Mechanical and other specified hazards only in accordance with: • • • •

IEC 60601-1 Ed. 3.1 2012-08 IEC 60601-2-2:2017; IEC 60601-2-22:2019; IEC 80601-2-58:2014/A1:2016

and for EMC: • •

47 CFR Part 15 Subpart B; IEC 60601-1-2:2015

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Essential performance As stated in the applicable safety standards pertaining to electrical medical devices (IEC60601-1 and IEC 80601-2-58), the manufacturer has determined that the medical device does not manage essential performances.

1.4 Liability D.O.R.C. International does not accept any liability for unsafe situations, accidents and/or damage or loss resulting from one of the following causes: • warnings or instructions as shown on the Ophthalmic Surgical System or contained in this • • •

Instruction Manual being ignored, the Ophthalmic Surgical System being used for other applications or in other conditions than specified in this Instruction Manual, changes of any kind or nature being made to the Ophthalmic Surgical System. This also includes the use of other spare parts and changing the internal operating program. insufficient maintenance.

D.O.R.C. International does not accept any liability for consequential damage or loss due to a faulty Ophthalmic Surgical System, such as damage to products, business interruptions, loss of production, etc.

1.5 Guarantee D.O.R.C. International warrants that all possible care was used in the choice of materials and manufacture of its products. The D.O.R.C. International warranty will not be valid in case non-original D.O.R.C. International consumables and/or spare parts are used or if the equipment is opened (even partially), modified or repaired in any way by persons who are not authorized by D.O.R.C. International. D.O.R.C. International shall not be liable for any incidental or consequential loss, damage or expense, arising from abuse of its products. However, if D.O.R.C. International’s investigation shows that its products were defective at the time of shipment by D.O.R.C. International, products will be replaced/repaired at no charge. Otherwise all D.O.R.C. International equipment is covered with a full year warranty, which does not cover the accessories nor consumables. D.O.R.C. International neither assumes nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with its products.

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1.6 Terminology Term (process)

Explanation

Automatic Infusion Compensation (AIC)

With the AIC function enabled, when the pedal is pressed to activate Aspiration, the Infusion pressure will be automatically controlled by EVA NEXUSTM to increase or decrease proportional to the actual Aspiration. AIC is only possible in Anterior and Posterior steps with Aspiration.

Backflush

Backflush is used on the EVA NEXUSTM system as the term of neutralizing the aspiration vacuum or actively irrigating through the aspiration port, EVA NEXUSTM has 4 backflush functions implemented: • Manual Backflush: When activated vacuum is neutralized to bottle pressure. Outside the eye, it allows for BSS to flow from the aspiration port of the instrument. • Proportional Backflush: When activated the aspiration pressure is controlled continuously by the user to a level above the irrigation/ infusion pressure to obtain variable irrigation from the active aspiration port. • Micro Backflush: When activated a pulse of irrigation will be produced from the active aspiration instrument. • Auto Backflush: A function which will neutralize the vacuum in the aspiration instrument. Starts automatically when aspiration is stopped by releasing the pedal.

Smart Intra Ocular Pressure (Smart IOP)

With the Smart IOP function enabled, when the pressure in the eye changes due to aspiration or otherwise, the infusion pressure will be automatically controlled by EVA NEXUSTM to increase or decrease to reach the desired setpoint. Smart IOP is only possible in procedure steps with Vitrectomy or Phaco.

Micro Injection (MI)

Delivering a small amount of aqueous fluid though a high gauge delivery device into the eye.

VacuFlow VTi

Advanced fluid control system (Valve Timing intelligence)

Viscous Fluid Extraction (VFE)

Extracting intraocular viscous fluid from the eye into a syringe

Viscous Fluid Injection (VFI)

Injecting viscous fluid from a syringe into the eye

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Instruction Manual Ophthalmic Surgical System Chapter 1 - Introduction

1.7 Abbreviations Abbreviation

Explanation

3D

3 Dimensional

AIC

Automatic Infusion Compensation

BF

Backflush

BSS

Balanced Salt Solution

cmH2O

Pressure in Centimeter Water Column

cpm

Cuts per minute

DL

Dual Linear

DLR

Dual Linear Reversed

DLS

Dual Linear Standard

GUI

Graphical User Interface

HF

High Frequency

IOP

Intra Ocular Pressure

LED

Light Emitting Diode

LIO

Laser Indirect Ophthalmoscope

mbar

Pressure in Millibar

MI

Micro Injection

mmHg

Pressure in Millimeter Mercury Column

ms

Millisecond

na

Not Applicable

OR

Operating Room

pps

Pulse per second

psi

Pressure in Pound-Force per Square Inch

VFC

Viscous Fluid Control

VFE

Viscous Fluid Extraction

VFI

Viscous Fluid Injection

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1.8 Symbols The following symbols are used in / on the Ophthalmic Surgical System, in the labeling of instruments and in the packaging for transport. Symbol

Description

Symbol

Description

Warning

Caution

Information to read carefully

Tip or Suggestion

Consult instructions for use

Non-ionizing electromagnetic radiation

Dispose of equipment and parts properly

Class II equipment

Type BF applied part

OFF (Power: Disconnection from the mains)

Alternating current

ON (Power: Connection to the mains)

ON / OFF (push-push) NOTE Each position, ON or OFF, is a stable

Protective Earth; Protective Ground

position Equipotentiality

Caution: Federal law restricts sale of this device by or on order of a licensed physician.

Protected against the effects of continuous immersion in water

Refer to instruction manual/booklet

Direct current

LED Footswitch: ONLINE

LED Footswitch: BATTERY

Catalogue Number

Serial Number

Manufacturer

Date of Manufacture

Non-Sterile

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Symbol

Description

Symbol

Description

Keep away from sunlight

Humidity limitation

Atmospheric pressure limitation

Fragile, handle with care

Temperature limitation

This way up

Keep away from rain

Electrostatic sensitive device

Do not stack

User Protection Filter connection

Immediate stop, laser light source

Warning; Laser beam

Door Interlock connection

Unique Device Indentifier

Medical Device

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1.8.1 Symbol

Symbols used on the EVA NEXUSTM and in the Graphic User Interface

Description

Symbol

Description

Main screen Surgeon

Shut down the system

• •

Procedure

Return to previous screen Return to main menu

Go to Priming

User settings

Diathermy (direct)

Surgical summaries

System settings

Help

Laser Indirect

Symbol

Description

Symbol

Description

Priming/Repriming screen Priming: Start/automatically continue

Priming: Pause

Change BSS container

Prime instruments

Fill cup

Release Cartridge

Laser pincode

Draining

Tune handpiece

Summon priming instructions video

BSS Container volume indicator

Patient Eye Level

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Symbol

Description

Symbol

Description

Symbol

Description

Change BSS container volume

Symbol

Description

Bottom bar (priming screen/surgery screen/step manager)

Symbol

Pedal indication (for more information see Sect. ’Footswitch indicators in Bottom Bar’ (page 23)

Battery indication (for more see Sect. ’Battery indicators in bottom bar’ (page 24)

Timer

Go to Priming

Stopwatch off

Select Options

Stopwatch on

Screen Brightness

Save

Volume

Return to surgery

Quick settings

Description

Symbol

Description

Functions Diathermy: Off

Diathermy mode: Linear

Diathermy: Active

Diathermy mode: Fixed

Diathermy mode: Diathermy with Aspiration

Phaco

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Pedal mode (Ph.): Linear