Carl Zeiss
OPMI LUMERA
OPMI Lumera 700 + RESCAN 700 Incl. Digital Option Instructions for Use Sw Release 3.2 Nov 2020
Instructions for Use
280 Pages
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Page 1
OPMI Lumera 700 + RESCAN 700 with Digital Option Software Release 3.2
Instructions for Use
Copyright © 2020, 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 with 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 ... Conventions in all text areas... Conventions in a course of action...
11 11 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 ...
15 15 16 16 18
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... Before commissioning for the first time ... Before every use... During operation ... After every use ...
23 23 23 26 27
2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5
Measures to prevent phototoxic injury ... Illumination characteristics (spectral composition)... Illumination intensity ... Angle of illumination ... Focus of the light source ... Exposure time to light ...
28 28 28 29 29 29
2.8 2.8.1 2.8.2
Maximum radiation exposure... Maximum radiation exposure times... References ...
31 32 33
3
Description of the device... 35
3.1
Device marking...
35
3.2
Labeling on packaging ...
40
3.3
Device setup ...
41
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Table of Contents
Instructions for Use OPMI Lumera 700 + RESCAN 700 with 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 video monitor... Support arm for integrated video 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) ...
42 43 43 45 45 46 46 48 49 50 52 52 53 53 54 54 55 55 55 56 57 57 58 60 60 61
3.4
Control elements and displays ...
62
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...
62 62 63 64 65 67 68 69 69 70 70 71 72 73 74 76 77 78
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 ... Structure of the operating panel... Bottom bar... Status bar... Color code ... Interactive buttons ... Navigation buttons... Control panel keyboard ... Settings for daily operation - main menu, tab 1 ...
79 79 80 80 81 81 83 84 85
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Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
Table of Contents
3.5.9 3.5.10 3.5.11
Basic device settings - main menu, tab 2 ... Factory settings for handgrips and 14-function foot control panel... Configurable assignments for handgrips and the 14-function foot control panel ...
86 87 91
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 ... Operating concept ... SCI illumination ... Main and auxiliary light source ... OCT function... Total magnification ... Fast focus... RESIGHT functions... DeepView ... Reset options ... Links... Manual mode... Assistant's microscope ... IDIS (Integrated Data Injection System)... Integrated HD camera ... Integrated 4K cameras (digital surgical microscope)... Integrated HD video and image recording ... HD video and image recording (digital surgical microscope) ...
93 93 95 95 96 97 97 98 98 99 99 100 100 101 101 102 103 103
4
Installation ... 105
4.1
Safety during installation... 105
4.2 4.2.1
Preparing the installation ... 105 Requirements for connecting the device to an IT network ... 105
4.3
Connections... 107
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... Connecting the power supply to the monitor cart (digital surgical microscope)... Connecting the 14-function foot control panel... Setting up a network connection with the CALLISTO eye Panel PC ... Setting up a network connection with integrated CALLISTO eye Panel PC ... Connecting IDIS via CALLISTO eye Panel PC... Connecting external video devices... Connecting the video and network cables to the monitor cart (digital surgical microscope) ... Setting up a network connection between CALLISTO eye and OPMI ... Connecting the strain relief ... Connecting a 3D monitor from a third-party manufacturer...
5
Daily startup... 121
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 ... 121 Replacing accessories and components ... 121 Connecting the Invertertube E ... 124 Connecting RESIGHT 700 ... 126 Connecting auxiliary illumination ... 127 Balancing the system... 127
5.2 5.2.1 5.2.2 5.2.3
Adjusting the surgical and assistant's microscopes ... 130 Adjusting the downward travel limit... 130 Adjusting friction... 131 Positioning the assistant's microscope ... 131
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Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
5.2.4 5.2.5 5.2.6 5.2.7
Adjusting microscope tilt ... Adjusting the tubes and eyepieces... Adjusting the working distance and magnification ... Using the digital video system for observation without eyepieces (digital surgical microscope) ...
131 132 134 134
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... 137 Moving the OPMI ... 137 Swiveling the device over the surgical field ... 138 Bringing the OPMI into the working position... 139 Monitor cart (digital surgical microscope) ... 140 Positioning the CALLISTO eye Panel PC... 142 Adjusting the integrated video monitor ... 143
6
Before every use... 145
6.1
Safety during preparation... 145
6.2
Switching the device on ... 146
6.3
Function test ... 147
6.3.1 6.3.2
Device function tests ... 148 Function tests for device with fundus viewing system... 150
6.4
Preparing the system for sterile use ... 151
6.4.1 6.4.2
Attaching sterile accessories ... 151 Placing the drape ... 152
7
Operation ... 155
7.1
Safety during operation... 155
7.2
3D-4K monitor settings ... 156
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... 159 Creating and activating users... 159 Changing the user language... 160 Deleting users ... 161 Creating a "Cataract" surgery profile ... 161 Creating a "Retina RESIGHT" surgery profile ... 162 Creating a "Retina Contact" surgery profile ... 162 Assigning the RESIGHT function to the surgery profile ... 164 Configuring working steps ... 164 Deleting a surgery profile ... 165
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 ... 165 Setting the date and time ... 166 Configuring optics ... 166 Pairing... 167 Configuring the video signal of the integrated camera... 168 Configuring the network connection with CALLISTO eye ... 169 Configuring integrated HD video and image recording ... 171 Configuring the 3D video recording... 173
7.5 7.5.1 7.5.2 7.5.3 7.5.4
Configuring the software for specific users ... 173 Configuring the 14-function foot control panel ... 174 Activating the OCT foot control panel configuration... 175 Configuring the handgrips... 175 Configuring image inversion on the Invertertube E ... 176
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Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
Table of Contents
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... Configuring speeds... Configuring the speed of the RESIGHT 700 internal focus... Configuring the overhead display ... Configuring fast focus ... Configuring links ... Configuring reset options ...
7.6
Using the digital video system for observation without eyepieces (digital surgical microscope) ... 181
7.6.1 7.6.2 7.6.3
White balancing ... 181 Performing an operation on the 3D monitor... 183 Completing the operation ... 184
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 ... 184 Setting the illumination ... 184 Setting the total magnification ... 188 Setting DeepView... 189 Setting the focus distance ... 189 Changing the XY coupling position ... 190 Setting the integrated keratoscope ring... 191 Setting the HD Digizoom ... 191 Setting the integrated HD camera ... 192 Setting the integrated 4K cameras (digital surgical microscope) ... 196 Recording... 200 Transferring control to CALLISTO eye ... 208 Ending control via CALLISTO eye ... 209
7.8
Typical operating sequence ... 210
7.8.1 7.8.2 7.8.3
Starting work ... 210 Carrying out the working steps... 212 Stopping work ... 213
7.9
Switching the device off ... 213
8
Cleaning and disinfection ... 215
8.1
Safety during cleaning and disinfection... 215
8.2 8.2.1 8.2.2 8.2.3 8.2.4
Cleaning ... 215 Cleaning optical surfaces ... 215 Cleaning the touchscreen ... 215 Cleaning mechanical surfaces ... 216 Fogging of optical surfaces... 216
8.3 8.3.1
Disinfection ... 216 Disinfecting the mechanical surfaces ... 216
9
Maintenance ... 219
9.1 9.1.1
Maintenance schedule for the operator... 219 Every six months... 219
9.2 9.2.1 9.2.2 9.2.3
Maintenance schedule for the authorized service... 219 Every twelve months ... 219 Every two years ... 220 Every four years... 221
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Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
9.2.4
Every six years ... 221
9.3
Performing safety inspections ... 221
10
Troubleshooting... 223
10.1 10.1.1 10.1.2
Localizing malfunctions ... 223 Response to faults with messages ... 223 Exporting log files... 223
10.2
Faults (with messages) ... 224
10.3 10.3.1 10.3.2 10.3.3 10.3.4 10.3.5
Faults (without messages) ... 225 Device faults... 225 Integrated video and image recording faults... 227 14-function foot control panel faults ... 228 Wired 14-function foot control panel faults... 229 Monitor cart / 3D monitor faults... 229
10.4 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
Troubleshooting work ... 230 Activating manual mode... 230 Operating the device in manual mode ... 231 Swiveling the backup xenon lamp into position and resetting the remaining service hours ... 232 Changing the Superlux Eye light source lamp module... 234 Setting the gas spring on the integrated video monitor ... 235 Increasing mobility of the suspension arm on the integrated video monitor... 235 Increasing mobility of the monitor mount on the integrated video monitor ... 236 Increasing mobility of the monitor mount on the integrated CALLISTO eye Panel PC support arm 237 Establishing cable connections for the 14-function foot control panel ... 237 Replacing the fuses ... 238 Displaying the firmware versions ... 239 Opening the service menu ... 239
10.5
Service information ... 239
11
Technical specifications... 241
11.1
Essential performance features ... 241
11.2
Regulatory information ... 241
11.3
Bluetooth module... 241
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 11.4.13
Electrical data... 241 Stand ... 241 Light sources ... 242 Integrated HD camera ... 242 Integrated 4K cameras (digital surgical microscope)... 243 Integrated HD video and image recording ... 244 Integrated 4K video and image recording on the monitor cart (digital surgical microscope) ... 245 Integrated keratoscope ring ... 245 Integrated 22" monitor ... 245 Integrated 23.6"monitor ... 246 HD OCT imaging ... 246 SLD light source of the OCT engine ... 247 Monitor cart... 247 4K-2D video outputs ... 248
11.5
Mechanical data ... 248
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Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
Table of Contents
11.5.1 11.5.2 11.5.3
Integrated 22" monitor ... 248 Integrated 23.6"monitor ... 248 Monitor cart... 248
11.6 11.6.1 11.6.2 11.6.3
Optical data... 248 Surgical microscope... 248 Objective lenses... 249 Eyepieces ... 249
11.7 11.7.1 11.7.2 11.7.3 11.7.4 11.7.5 11.7.6
Dimensions and weights... 250 Dimensions and swiveling ranges ... 250 Support arm for integrated CALLISTO eye Panel PC ... 251 Support arm for integrated video monitor ... 252 Maximum weight capacity... 253 Total weight... 253 Monitor cart... 254
11.8
Ambient requirements for operation ... 255
11.9
Ambient requirements for transport and storage ... 255
11.10
Guidance and manufacturer´s declaration – electromagnetic immunity... 255
11.10.1 Electromagnetic disturbance emissions... 256 11.10.2 Electromagnetic immunity for all ME equipment and ME systems... 257 11.10.3 Electromagnetic immunity for non-life-supporting ME equipment and ME systems... 258
12
Accessories and components ... 259
12.1 12.1.1 12.1.2 12.1.3 12.1.4 12.1.5 12.1.6
Accessories ... 259 Fundus viewing systems ... 259 Additional illumination ... 259 Products that can be reprocessed (sterilization) ... 259 Drapes... 260 CALLISTO eye ... 260 Video accessories ... 260
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 ... 260 14-function foot control panel ... 260 3D monitor with cart... 261 Tubes for surgical and assistant's microscopes... 261 Eyepieces for surgical and assistant's microscopes ... 261 Intermediate pieces for surgical microscope ... 261 Objective lenses... 262 Coobservation ... 262 Integrated components (factory installed)... 262 Lamps and light guides... 263 Dust cover... 263 Network cable... 263 Country-specific power cable... 263 Fuses... 263
12.3
UC kits ... 263
13
Decommissioning ... 265
13.1 13.1.1
Cleaning before storage ... 265 Cleaning the device and accessories ... 265
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Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
14
Packaging and transport... 267
14.1 14.1.1
Preparing for transport... 267 Placing the device in the transport position ... 267
15
Disposal ... 269
15.1
Environmental pollution ... 269
15.2
Disposal of the device... 269
Glossary ... 271 Index ... 273
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Instructions for Use OPMI Lumera 700 + RESCAN 700 with 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. Action
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 Action
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 with 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. Action
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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Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
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 with 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 with 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 with 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
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2 Safety notes 2.2 Area of use
Instructions for Use OPMI Lumera 700 + RESCAN 700 with Digital Option
imaging data from each surgical operation and each patient can be stored on a USB device for further documentation and presentation. 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 with 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 with 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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