OPMI Lumera 700 incl. Digital Option Instructions for Use Sw Release 3.2 Dec 2019

Copyright © 2019, Carl Zeiss Meditec AG, Jena Brands CALLISTO eye, Invertertube, HaMode, MEDIALINK, OPMI Lumera, RESCAN, RESIGHT, SCI, Superlux, VISULUX and Visionguard are either trademarks or registered trademarks of Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany and/or other countries. All other brands mentioned in this document are the property of their respective owners.

Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

Table of contents

Table of contents 1

Notes on the instructions for use ... 11

1.1

Device name ... 11

1.2

Area of application ... 11

1.3

Purpose and storage of the documentation ... 11

1.4

Questions and comments ... 11

1.5 1.5.1 1.5.2

Conventions in this document ... 11 Conventions in all text areas... 11 Conventions in a course of action... 12

1.6

Other applicable documents ... 13

2

Safety notes ... 15

2.1

Target group ... 15

2.2

Area of use ... 15

2.2.1 2.2.2 2.2.3 2.2.4 2.2.5

Intended uses... Indication for use ... Contraindication... Normal use... Patient target group ...

2.3

Responsibilities and duties of the operator ... 19

2.3.1

Messages to manufacturer and authorities ... 20

2.4

Measures and duties of the operator... 21

2.5

Electromagnetic compatibility ... 22

2.6 2.6.1 2.6.2 2.6.3 2.6.4

Requirements for operation... 23 Before commissioning for the first time ... 23 Before every use... 24 During operation ... 26 After every use ... 28

2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5

Measures to prevent phototoxic injury ... 28 Illumination characteristics (spectral composition)... 28 Illumination intensity ... 29 Angle of illumination ... 29 Focus of the light source ... 29 Exposure time to light ... 30

2.8 2.8.1 2.8.2 2.8.3

Maximum radiation exposure... 32 Maximum radiation exposure times with red reflex illumination ... 32 Maximum radiation exposure times with surrounding field illumination... 32 References ... 33

3

Description of the device... 35

3.1

Device marking... 35

3.2

Labeling on packaging ... 40

3.3

Device setup ... 42

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Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 3.3.9 3.3.10 3.3.11 3.3.12 3.3.13 3.3.14 3.3.15 3.3.16 3.3.17 3.3.18 3.3.19 3.3.20 3.3.21 3.3.22 3.3.23 3.3.24 3.3.25 3.3.26

CALLISTO eye Panel PC... Support arm for CALLISTO eye Panel PC ... Lamp housing ... Suspension arm ... XY coupling... Overhead display... Surgical microscope... Digital surgical microscope ... Assistant's Microscope (optional)... Monitor cart (digital surgical microscope) ... 14-function foot control panel ... Support arm ... Stand base ... OCT E-box connector panel ... Stand column ... Integrated 22" monitor ... Support arm for integrated 22" monitor... Instrument tray... Integrated keratoscope ring ... Connections on the surgical microscope... Connections on the assistant's microscope... OCT E-box connector panel ... Digital surgical microscope connector panel ... Monitor cart connector panel... CALLISTO eye Panel PC connector panel (model I) ... CALLISTO eye Panel PC connector panel (model II) ...

43 43 44 45 46 46 47 49 49 50 52 52 53 53 54 54 55 55 56 56 57 58 59 60 61 62

3.4

Control elements and displays ... 63

3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6 3.4.7 3.4.8 3.4.9 3.4.10 3.4.11 3.4.12 3.4.13 3.4.14 3.4.15 3.4.16 3.4.17 3.4.18

Superlux Eye light source fault signal ... LED light source fault signal... Manual mode fault signal ... Overhead display... Surgical microscope... Digital surgical microscope ... Assistant's microscope ... Invertertube E... Widefield eyepiece ... Handgrips... 14-function foot control panel ... XY coupling... Suspension arm ... Control panel ... Monitor cart (digital surgical microscope) ... CALLISTO eye Panel PC (model I) ... CALLISTO eye Panel PC (model II) ... Superlux Eye light source...

3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8

Software description ... 80 Structure of the operating panel... 80 Bottom bar... 81 Status bar... 82 Color code ... 82 Interactive buttons ... 83 Navigation buttons... 85 Control panel keyboard ... 86 Settings for daily operation - main menu, tab 1 ... 87

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Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

Table of contents

3.5.9 3.5.10 3.5.11

Basic device settings - main menu, tab 2 ... 88 Factory settings for handgrips and 14-function foot control panel... 89 Configurable assignments for handgrips and the 14-function foot control panel ... 93

3.6 3.6.1 3.6.2 3.6.3 3.6.4 3.6.5 3.6.6 3.6.7 3.6.8 3.6.9 3.6.10 3.6.11 3.6.12 3.6.13 3.6.14 3.6.15 3.6.16 3.6.17

Functional description ... 96 Operating concept ... 96 SCI illumination ... 97 Main and auxiliary light source ... 98 OCT function... 99 Total magnification ... 100 Fast focus... 100 RESIGHT functions... 101 DeepView ... 102 Reset options ... 102 Links... 103 Manual mode... 103 Assistant's microscope ... 104 IDIS (Integrated Data Injection System)... 104 Integrated HD camera ... 104 Integrated 4K cameras (digital surgical microscope)... 105 Integrated HD video and image recording ... 106 4K video and image recording (digital surgical microscope) ... 107

4

Installation ...109

4.1

Safety during installation...109

4.2 4.2.1

Preparing the installation ...110 Requirements for connecting the device to an IT network ... 110

4.3

Connections...112

4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.3.7 4.3.8 4.3.9 4.3.10 4.3.11

Connecting the power supply... 112 Connecting the power supply to the monitor cart (digital surgical microscope)... 113 Connecting the 14-function foot control panel... 114 Setting up a network connection with the CALLISTO eye Panel PC ... 115 Setting up a network connection with integrated CALLISTO eye Panel PC ... 118 Connecting IDIS via CALLISTO eye Panel PC... 119 Connecting external video devices... 121 Connecting the video and network cables to the monitor cart (digital surgical microscope) ... 123 Setting up a network connection between CALLISTO eye and OPMI ... 124 Connecting the strain relief ... 124 Connecting a 3D monitor from a third-party manufacturer... 125

5

Daily startup...127

5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5

Outfitting the surgical and assistant's microscopes with accessories ...127 Replacing accessories and components ... 127 Connecting the Invertertube E ... 131 Connecting RESIGHT 700 ... 133 Connecting auxiliary illumination ... 133 Balancing the system... 134

5.2 5.2.1 5.2.2 5.2.3

Adjusting the surgical and assistant's microscopes ...136 Adjusting the downward travel limit... 136 Adjusting friction... 137 Positioning the assistant's microscope ... 137

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Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

5.2.4 5.2.5 5.2.6 5.2.7

Adjusting microscope tilt ... 138 Adjusting the tubes and eyepieces... 139 Adjusting the working distance and magnification ... 140 Using the digital video system for observation without eyepieces (digital surgical microscope) ... 141

5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.6

Positioning the device in the OR...143 Moving the OPMI ... 143 Swiveling the device over the surgical field ... 145 Bringing the OPMI into the working position... 146 Monitor cart (digital surgical microscope) ... 147 Positioning the CALLISTO eye Panel PC... 149 Orienting the integrated 22" monitor ... 151

6

Before every use...153

6.1

Safety during preparation...153

6.2

Switching the device on ...154

6.3

Function test ...155

6.3.1 6.3.2

Device function tests ... 155 Function tests for device with fundus viewing system... 157

6.4

Preparing the system for sterile use ...158

6.4.1 6.4.2

Attaching sterile accessories ... 158 Placing the drape ... 160

7

Operation ...161

7.1

Safety during operation...161

7.2

3D-4K monitor settings ...163

7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.3.8 7.3.9

Configuring user and surgery profiles...165 Creating and activating users... 165 Changing the user language... 166 Deleting users ... 167 Creating a "Cataract" surgery profile ... 167 Creating a "Retina RESIGHT" surgery profile ... 168 Creating a "Retina Contact" surgery profile ... 169 Assigning the RESIGHT function to the surgery profile ... 170 Configuring working steps ... 171 Deleting a surgery profile ... 172

7.4 7.4.1 7.4.2 7.4.3 7.4.4 7.4.5 7.4.6 7.4.7

Device-specific software configuration ...172 Setting the date and time ... 172 Configuring optics ... 173 Pairing... 174 Configuring the video signal of the integrated camera... 175 Configuring the network connection with CALLISTO eye ... 176 Configuring integrated HD video and image recording ... 178 Configuring the 3D video recording... 180

7.5 7.5.1 7.5.2 7.5.3 7.5.4

Configuring the software for specific users ...181 Configuring the 14-function foot control panel ... 181 Activating the OCT foot control panel configuration... 182 Configuring the handgrips... 183 Configuring image inversion on the Invertertube E ... 184

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7.5.5 7.5.6 7.5.7 7.5.8 7.5.9 7.5.10 7.5.11

Configuring the direction of the XY coupling... 184 Configuring speeds... 184 Configuring the speed of the RESIGHT 700 internal focus... 185 Configuring the overhead display ... 185 Configuring fast focus ... 186 Configuring links ... 187 Configuring reset options ... 188

7.6

Using the digital video system for observation without eyepieces (digital surgical microscope) ...189

7.6.1 7.6.2 7.6.3

White balancing ... 189 Performing an operation on the 3D monitor... 191 Completing the operation ... 192

7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.7.6 7.7.7 7.7.8 7.7.9 7.7.10 7.7.11 7.7.12

Daily operation ...192 Setting the illumination ... 193 Setting the total magnification ... 196 Setting DeepView... 197 Setting the focus distance ... 198 Changing the XY coupling position ... 199 Setting the integrated keratoscope ring... 199 Setting the HD Digizoom ... 200 Setting the integrated HD camera ... 201 Setting the integrated 4K cameras (digital surgical microscope) ... 205 Recording... 209 Transferring control to CALLISTO eye ... 219 Ending control via CALLISTO eye ... 220

7.8

Typical operating sequence ...221

7.8.1 7.8.2 7.8.3

Starting work ... 221 Carrying out the working steps... 223 Stopping work ... 224

7.9

Switching the device off ...225

8

Cleaning and disinfection ...227

8.1

Safety during cleaning and disinfection...227

8.2 8.2.1 8.2.2 8.2.3 8.2.4

Cleaning ...227 Cleaning optical surfaces ... 227 Cleaning the touchscreen ... 228 Cleaning mechanical surfaces ... 228 Fogging of optical surfaces... 228

8.3 8.3.1

Disinfection ...229 Disinfecting the mechanical surfaces ... 229

9

Maintenance ...231

9.1 9.1.1

Maintenance schedule for the operator...231 Every six months... 231

9.2 9.2.1 9.2.2 9.2.3

Maintenance schedule for the authorized service...231 Every six months... 231 Every twelve months ... 231 Every two years ... 233

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Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

9.2.4 9.2.5

Every four years... 233 Every six years ... 233

9.3

Performing safety inspections ...234

10

Troubleshooting...235

10.1 10.1.1 10.1.2

Localizing malfunctions ...235 Response to faults with messages ... 235 Exporting log files... 235

10.2

Faults (with messages) ...236

10.3 10.3.1 10.3.2 10.3.3 10.3.4 10.3.5

Faults (without messages) ...237 Device faults... 237 Integrated video and image recording faults... 240 14-function foot control panel faults ... 241 Wired 14-function foot control panel faults... 242 Monitor cart / 3D monitor faults... 243

10.4

Troubleshooting work ...244

10.4.1 10.4.2 10.4.3 10.4.4 10.4.5 10.4.6 10.4.7 10.4.8 10.4.9 10.4.10 10.4.11 10.4.12

Activating manual mode... 244 Operating the device in manual mode ... 245 Swiveling the backup xenon lamp into position and resetting the remaining service hours ... 246 Changing the Superlux Eye light source lamp module... 248 Setting the gas spring on the integrated 22" monitor ... 249 Increasing mobility of the suspension arm on the integrated 22" monitor ... 250 Increasing mobility of the monitor mount on the integrated 22" monitor ... 251 Increasing mobility of the monitor mount on the integrated CALLISTO eye Panel PC support arm . 251 Establishing cable connections for the 14-function foot control panel ... 252 Replacing the fuses ... 253 Displaying the firmware versions ... 254 Opening the service menu ... 254

11

Technical specifications...255

11.1

Essential performance features ...255

11.2

Regulatory information ...255

11.3

Bluetooth module...255

11.4 11.4.1 11.4.2 11.4.3 11.4.4 11.4.5 11.4.6 11.4.7 11.4.8 11.4.9 11.4.10 11.4.11 11.4.12

Electrical data...256 Stand ... 256 Light sources ... 256 Integrated HD camera ... 257 Integrated 4K cameras (digital surgical microscope)... 258 Integrated HD video and image recording ... 258 Integrated 4K video and image recording on the monitor cart (digital surgical microscope) ... 260 Integrated keratoscope ring ... 260 Integrated 22" monitor ... 260 HD OCT imaging ... 261 SLD light source of the OCT engine ... 262 Monitor cart... 262 4K-2D video outputs ... 262

11.5 11.5.1

Mechanical data ...262 Integrated 22" monitor ... 262

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Table of contents

11.5.2

Monitor cart... 263

11.6 11.6.1 11.6.2 11.6.3

Optical data...263 Surgical microscope... 263 Objective lenses... 263 Eyepieces ... 263

11.7

Dimensions and weights...264

11.7.1 11.7.2 11.7.3 11.7.4 11.7.5 11.7.6

Dimensions and swiveling ranges ... 264 Support arm for integrated CALLISTO eye Panel PC ... 265 Support arm for integrated 22" monitor... 266 Maximum weight capacity... 267 Total weight... 267 Monitor cart... 268

11.8

Ambient requirements for operation ...269

11.9

Ambient requirements for transport and storage ...269

11.10 11.10.1 11.10.2 11.10.3

Guidance and manufacturer´s declaration – electromagnetic immunity...270 Electromagnetic disturbance emissions... 271 Electromagnetic immunity for all ME equipment and ME systems... 272 Electromagnetic immunity for non-life-supporting ME equipment and ME systems... 273

12

Accessories and components ...275

12.1 12.1.1 12.1.2 12.1.3 12.1.4 12.1.5 12.1.6

Accessories ...275 Fundus viewing systems ... 275 Additional illumination ... 275 Products that can be reprocessed (sterilization) ... 275 Drapes... 276 CALLISTO eye ... 276 Video accessories ... 276

12.2 12.2.1 12.2.2 12.2.3 12.2.4 12.2.5 12.2.6 12.2.7 12.2.8 12.2.9 12.2.10 12.2.11 12.2.12 12.2.13

Components ...277 14-function foot control panel ... 277 3D monitor with cart... 277 Tubes for surgical and assistant's microscopes... 277 Eyepieces for surgical and assistant's microscopes ... 277 Intermediate pieces for surgical microscope ... 278 Objective lenses... 278 Coobservation ... 278 Integrated components (factory installed)... 278 Lamps and light guides... 279 Dust cover... 279 Network cable... 279 Country-specific power cable... 279 Fuses... 279

12.3

UC kits ...280

13

Decommissioning ...281

13.1 13.1.1

Cleaning before storage ...281 Cleaning the device and accessories ... 281

14

Packaging and transport...283

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14.1 14.1.1

Preparing for transport...283 Placing the device in the transport position ... 283

15

Disposal ...285

15.1

Environmental pollution ...285

15.2

Disposal of the device...285

Glossary ...287 Keyword index ...289

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Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

1 Notes on the instructions for use 1.1 Device name

1 Notes on the instructions for use 1.1 Device name OPMI Lumera 700 + RESCAN 700 is referred to as "device" in these Instructions for Use.

1.2 Area of application These Instructions for Use apply to OPMI Lumera 700 + RESCAN 700 with Software Release 3.2 and the following identification: • Reference number: 6634 (OPMI Lumera 700) • Reference number: 7210 (RESCAN 700 SW 2.0) • Material number: 305953-9050-000 (Monitor Cart (optional))

1.3 Purpose and storage of the documentation These instructions for use explain the safety features, functions and performance parameters of the device. They contain instructions on the safe use of the device and identify measures for its care and maintenance. Correct operation of the device is imperative for its safe and successful function. u

Read these Instructions for Use before setting up and using the device the first time.

u

Keep the instructions for use accessible for all users at all times.

u

Pass the instructions for use to future owners of the device.

1.4 Questions and comments u

If you have questions or comments concerning these instructions for use or the device itself, contact ZEISS Service.

You can find the ZEISS contact partner for your country on the following website: www.zeiss.com/med

1.5 Conventions in this document Certain types of information are specially marked in this document for better recognition.

1.5.1 Conventions in all text areas • This is a list. – This is a second level list. This is a cross-reference: Questions and comments [} 11]. This is bold type.

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1 Notes on the instructions for use 1.5 Conventions in this document

Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

This is software code or program text. Names of software dialogs, fields or menus, and software messages are marked by quotation marks: • "View" menu. • "Do you want to save the settings?" The steps in menu and file paths are separated by slashes: • "File / Save as" • "My documents / Documents" Keys, buttons, knobs, levers and other operating controls are marked by square brackets: • [START] key • [Next] button

1.5.2 Conventions in a course of action

WARNING!

This is warning information about hazards that can cause death or severe injuries if not avoided. The warning message names the possible consequences. u

CAUTION!

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause injuries if not avoided. The warning message names the possible consequences. u

NOTE

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause property damages if not avoided. The warning message names the possible consequences. u

This is a measure with which hazards can be prevented.

þ This is a requirement that must be met before the start of a sequence of actions. 1. This is a command. 2. CAUTION! This is a warning message about hazards that can occur during a single action. This is a command. ð This is the result of a sequence of actions.

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1 Notes on the instructions for use 1.6 Other applicable documents

1.6 Other applicable documents

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Document type

Document title

Optional

Product overview

ZEISS Video Accessories

No

Instructions for Use

Preparation of Resterilizable Products

No

Instructions for Use

VISULUX

Yes

Instructions for Use

RESIGHT 500 & RESIGHT 700

Yes

Instructions for Use

CALLISTO eye

Yes

Instructions for Use

14-function foot control panel, wired (FCP) or wireless (FCP WL)

NO

Information

Radio Approval Information NO

Instructions for Use

CALLISTO eye Panel PC (model I)

NO

Instructions for Use

CALLISTO eye Panel PC (model II)

YES

Instructions for Use

CALLISTO eye Panel PC (model II) (digital surgical microscope)

NO

Instructions for Use

CALLISTO eye Basic Functions Software Version 3.7

No

Instructions for Use

CALLISTO eye - Software Add-On for OPMI Lumera 700 Control

NO

Instructions for Use

CALLISTO eye - Software Add-On for OCT with RESCAN 700

No

Instructions for Use

CALLISTO eye - Software Add-On for VISALIS 500 Parameter Display

YES

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Empty page, for your notes

Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

2 Safety notes 2.1 Target group

2 Safety notes 2.1 Target group These Instructions for Use are intended for physicians, medical and technical staff, and nurses who are responsible for preparing, operating or maintaining the device following training. It is the duty of the equipment owner/operator to train and instruct all operating personnel.

2.2 Area of use 2.2.1 Intended uses OPMI Lumera is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures in the field of ophthalmology. The RESCAN 700 is intended to acquire high resolution OCT images of the anterior and posterior segments of the eye in real time during surgical procedures. It enables the application of OCT functionality to an ophthalmic surgical microscope and provides OCT image data to an assistance system. The product includes an interface for remote control by an assistance system.

2.2.2 Indication for use OPMI Lumera 700 The device is intended only for surgical procedures in the field of ophthalmology. It illuminates and magnifies the structures of the eye (intraocular and extraocular) while the surgeon carries out the procedure. It can be used for all types of surgical procedure on the anterior and posterior segments of the eye, for various applications and diseases, e.g. • Cataract • Glaucoma • Retinal diseases • Corneal diseases • Vitrectomy RESCAN 700 The device allows high-resolution OCT imaging. It is intended for the intraoperative generation and visualization of OCT images of anterior and posterior ocular structures, including the cornea, iris angle, lens, retina and optic disc.

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2 Safety notes 2.2 Area of use

Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

The combination of OCT camera, ophthalmic surgical microscope, assistance system and fundus viewing system supports the surgeon during ophthalmic surgical procedures. The device can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope. The OCT images are then displayed to the surgeon in the eyepieces of the surgical microscope by means of data injection. The OCT images can be additionally displayed on the assistance system screen. The device is intended for use in ophthalmic surgeries only.

2.2.3 Contraindication The product may not be used for diagnostic purposes. Video images in particular, as well as recorded video and still images, can differ from the patient's real eye in terms of colour, contrast, size and form. For patients with serious retinal damage, the use of additional protective equipment to reduce light exposure is advised. This protective equipment consists of a blue filter and a retinal protection device.

2.2.4 Normal use

NOTE

Using the device OPMI Lumera 700 + RESCAN 700 with digital option may only be used with CALLISTO eye (Panel PC II). On account of its mechanical construction and the characteristics listed below, the device is suited for performing surgical procedures on the anterior and posterior segments of the eye: • SCI illumination system (Stereo Coaxial Illumination) • A range of illumination sources • Attachable fundus viewing systems (RESIGHT 500, RESIGHT 700) • VISULUX fiber slit illuminator Once the power switch has been activated, the device can be safely and easily moved into its operating position after the magnetic brakes have been released, either by using the handgrips or the suspension arm. Before the start of surgery, a sterile personnel member covers the microscope with drapes and applies resterilizable caps. The surgeon or a sterile personnel member positions the microscope and focuses it. During surgery, the most frequently used functions, such as focus, magnification, XY movement, light intensity up/down and adjustment of the illumination level, are controlled by means of the foot control panel, allowing the user's

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Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

2 Safety notes 2.2 Area of use

hands to remain free for the surgical procedure. Certain settings, such as the illumination level, unlocking of the magnetic brakes or the insertion of RESIGHT 500 or RESIGHT 700 for surgical procedures conducted on the posterior segment of the eye, are done by hand. For viewing or training purposes, the progress of the operation can be viewed by doctors and staff members on the 3D monitor jointly supplied in the digital option. When using this function, you can switch between two modes: Hybrid: "Viewing through the eyepiece is still possible" or Digital: "Viewing is only possible on the 3D monitor using the 3D glasses. Viewing through the eyepiece is no longer possible." In order for the physician and other personnel to continue viewing, additional video equipment can be installed on the device. For surgical procedures conducted on the posterior segment of the eye, specific contact lenses or RESIGHT 700 / RESIGHT 500 must be used. The OCT camera is only suitable for ophthalmic surgical procedures. The device can be used for anterior segment surgery. The OCT camera is installed in the surgical microscope and connected to an assistance system. This combination meets the requirements for anterior and posterior segment ophthalmic surgery. The OCT camera can be controlled hands-free via the surgical microscope's foot control panel or via the assistance system touch panel. Before and after surgery, the OCT camera is automatically switched on or off when the power button on the surgical microscope is pressed. The OCT camera's scanning mode must be activated separately during surgery. The surgeon can control the camera's key functions, such as starting and stopping scanning, positioning the scanner, capturing images and cube scans , and reviewing previous scans using either the foot control panel or the handgrips (depending on how the device has been configured). The OCT camera functions can also be controlled by means of the assistance system screen. See also: G-30-2003 CALLISTO eye Basic Functions. The OCT images can be used as live images for gaining instant information, as well as in review mode for observing images already taken at a previous point in time during surgery. The OCT images are displayed to the surgeon as "picture in picture" on the 3D monitor or in the eyepieces of the surgical microscope. The OCT images can be also be displayed on the assistance system screen for training purposes or to visually display the progress of surgery to personnel. The current patient's OCT images can be reviewed and checked directly during surgery via the assistance system. The imaging data from each surgical operation and each patient can be stored on a USB device for further documentation and presentation.

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2 Safety notes 2.2 Area of use

Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

When finished, the surgeon swivels the microscope out of the surgical field and into the park position. Pressing the reset button on the XY coupling, or positioning the device in the park position, resets the device to its initial values and makes it ready for the next operation. The drape or the resterilizable caps are removed by the surgeon or by a nurse. The drape is to be disposed of in accordance with the hospital regulations of the respective country. The resterilizable caps can be sterilized again. The device can be cleaned and disinfected. The product must be regularly checked for full functionality by a hospital technician. At the end of the electronic device's service life, it must be disposed of in accordance with the regulations of the respective country.

2.2.5 Patient target group

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Age

All age groups (from newborns through to the elderly)

Gender

All

State of health

Not relevant for the application

Weight

No limit

Status during surgery

Under local or general anaesthetic

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Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

2 Safety notes 2.3 Responsibilities and duties of the operator

2.3 Responsibilities and duties of the operator Operating personnel The device may only be operated by instructed and trained personnel. u

Ensure that the operating personnel have been trained and instructed.

u

Ensure that the operating personnel have read and understood the Instructions for Use.

u

Keep the Instructions for Use available at all times for the operating personnel.

u

To simplify access for all operating personnel, order additional copies of the Instructions for Use from ZEISS as required.

u

Define the required skills for handling the device and provide information on who is authorized for which activities.

u

Define rules for reporting errors and damage, and make sure that people are informed of these. Notification to manufacturers and authorities [} 20]

u

Provide the necessary protective clothing.

u

Regularly check compliance with the national laws and regulations concerning accident prevention and occupational health.

Safety inspections u

To prevent any reduction in device safety due to aging and wear: Have regular safety inspections performed which are set in accordance with the applicable national regulations for this device

The safety inspections may only be performed by the manufacturer or qualified personnel. u

Comply with the specified time limits.

u

Perform the inspections to the prescribed extent.

The device should, as a minimum, undergo the following checks and safety inspections: • Check that the Instructions for Use are present • Visually inspect the device and its accessories for damage, as well as legibility of markings and labels • Leakage current test • Test of protective ground conductor • Function and wear test of the brakes • Function test of all switches, buttons, sockets and LEDs on the device

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2 Safety notes 2.3 Responsibilities and duties of the operator

Instructions for Use OPMI Lumera 700 + RESCAN 700 incl. digital option

Maintenance and inspection u

To ensure safe operation of the device and reach the expected service life: observe the maintenance and inspection intervals that are specified in these instructions for use.

Changes to the product

NOTE

Unauthorized interference with the system This system must not be modified without the manufacturer's permission. If the system is modified after consultation with the manufacturer, suitable inspections and testing must be carried out to ensure subsequent safe use. The manufacturer is not liable for damage caused by unauthorized modifications to the system. Furthermore, this will forfeit any rights to claim under warranty. Accessories and additional equipment u

If you wish to connect accessories or additional equipment to the device: Contact your ZEISS representative [} 11].

Additional equipment connected to medical electrical devices must demonstrably comply with the corresponding IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, any configurations must comply with the requirements stipulated in standards for medical systems (see IEC 60601-1). If you connect additional devices to medical electrical systems, you are considered to be a system configurer and are thus responsible for ensuring that the system complies with the normative requirements for systems. Local laws take precedence over the above normative requirements.

2.3.1 Messages to manufacturer and authorities If a serious incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report this serious incident to the manufacturer or seller of the medical product. In the European Union, the operator must report this serious incident to the competent authority in his/her country.

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G-30-1904-en - 8.2 - 2019-12-09