OPMI Lumera 700 Instructions for Use Sw Ver 3.2 Sept 2020

Copyright © 2020, Carl Zeiss Meditec AG, Jena Brands CALLISTO eye, Invertertube, HaMode, K TRACK, OPMI Lumera, RESIGHT, SCI, Superlux, VISULUX, Visionguard and Z ALIGN 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

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... 12 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 ... 17

2.3.1

Messages to manufacturer and authorities ... 19

2.4

Measures and duties of the operator... 19

2.5

Electromagnetic compatibility ... 20

2.6 2.6.1 2.6.2 2.6.3 2.6.4

Requirements for operation... 21 Before commissioning for the first time ... 21 Before every use... 22 During operation ... 24 After every use ... 26

2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5

Measures to prevent phototoxic injury ... 26 Illumination characteristics (spectral composition)... 26 Illumination intensity ... 27 Angle of illumination ... 27 Focus of the light source ... 27 Exposure time to light ... 28

2.8 2.8.1 2.8.2

Maximum radiation exposure... 30 Maximum radiation exposure times... 30 References ... 32

3

Description of the device... 33

3.1

Device marking... 33

3.2

Labeling on packaging ... 36

3.3

Device setup ... 38

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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

Electronics box ... Lift arm or rigid arm ... Lamp housing ... Suspension arm ... XY coupling... Overhead display... Surgical microscope... Assistant's Microscope (optional)... 14-function foot control panel ... CALLISTO eye Panel PC... Support arm system ... Support arm for surgical lights... Integrated keratoscope ring ... Connector panel on standard wall mount... Connector panel on HD video wall mount ... CALLISTO eye Panel PC connector panel (model I) ... CALLISTO eye Panel PC connector panel (model II) ...

39 39 40 42 42 43 43 45 46 46 47 47 48 49 50 51 52

3.4 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 3.4.19

Control elements and displays ... 53 Superlux Eye light source fault signal ... 53 Halogen light source fault signal... 53 LED light source fault signal... 54 Manual mode fault signal ... 54 Overhead display... 55 Surgical microscope... 56 Assistant's microscope ... 58 Invertertube E... 59 Widefield eyepiece ... 59 Handgrips... 60 14-function foot control panel ... 60 XY coupling... 61 Suspension arm ... 62 Lift arm or rigid arm ... 63 Standard wall mount ... 64 CALLISTO eye Panel PC (model I) ... 65 CALLISTO eye Panel PC (model II) ... 66 Superlux Eye light source... 67 Halogen light source ... 67

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 3.5.9 3.5.10 3.5.11

Software description ... 68 Structure of the operating panel... 68 Bottom bar... 69 Status bar... 70 Color code ... 70 Interactive buttons ... 71 Navigation buttons... 73 Control panel keyboard ... 74 Settings for daily operation - main menu, tab 1 ... 75 Basic device settings - main menu, tab 2 ... 76 Factory settings for handgrips and 14-function foot control panel... 77 Configurable assignments for handgrips and the 14-function foot control panel ... 80

3.6 3.6.1 3.6.2 3.6.3

Functional description ... 82 Operating concept ... 82 SCI illumination ... 84 Main and auxiliary light source ... 85

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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

Total magnification ... Fast focus... RESIGHT functions... DeepView ... Reset options ... Links... Manual mode... Assistant's microscope ... IDIS (Integrated Data Injection System)... Integrated slit illumination ... Integrated HD camera ... Integrated HD video and image recording ...

4

Installation ... 93

4.1

Safety during installation... 93

4.2

Preparing the installation ... 94

4.2.1

Requirements for connecting the device to an IT network ... 94

4.3

Connections... 95

4.3.1 4.3.2 4.3.3 4.3.4

Connecting the 14-function foot control panel... 95 Setting up a network connection with the CALLISTO eye Panel PC ... 96 Connecting IDIS via CALLISTO eye Panel PC... 99 Connecting external video devices... 101

5

Daily startup...103

5.1

Outfitting the surgical and assistant's microscopes with accessories ...103

5.1.1 5.1.2 5.1.3 5.1.4 5.1.5

Replacing accessories and components ... 103 Connecting the Invertertube E ... 106 Connecting RESIGHT 700 ... 108 Connecting auxiliary illumination ... 109 Balancing the system... 109

5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6

Adjusting the surgical and assistant's microscopes ...112 Adjusting the downward travel limit... 112 Adjusting friction... 113 Positioning the assistant's microscope ... 113 Adjusting microscope tilt ... 114 Adjusting the tubes and eyepieces... 115 Adjusting the working distance and magnification ... 116

5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5

Positioning the device in the OR...117 Swiveling the device over the surgical field ... 117 Bringing the OPMI into the working position... 118 Placing the device in the working position (lift arm)... 119 Orienting the support arm system ... 121 Support arm park positions ... 122

6

Before every use...123

6.1

Safety during preparation...123

6.2

Switching the device on ...124

6.3

Function test ...125

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6.3.1 6.3.2

Device function tests ... 126 Function tests for device with fundus viewing system... 128

6.4 6.4.1 6.4.2

Preparing the system for sterile use ...129 Attaching sterile accessories ... 129 Placing the drape ... 131

7

Operation ...133

7.1

Safety during operation...133

7.2 7.2.1 7.2.2 7.2.3 7.2.4 7.2.5 7.2.6 7.2.7 7.2.8 7.2.9

Configuring user and surgery profiles...134 Creating and activating users... 134 Changing the user language... 136 Deleting users ... 137 Creating a "Cataract" surgery profile ... 137 Creating a "Retina RESIGHT" surgery profile ... 138 Creating a "Retina Contact" surgery profile ... 138 Assigning the RESIGHT function to the surgery profile ... 140 Configuring working steps ... 140 Deleting a surgery profile ... 141

7.3

Device-specific software configuration ...141

7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6

Setting the date and time ... 142 Configuring optics ... 142 Pairing... 143 Configuring the video signal of the integrated camera... 144 Configuring the network connection with CALLISTO eye ... 145 Configuring integrated HD video and image recording ... 147

7.4 7.4.1 7.4.2 7.4.3 7.4.4 7.4.5 7.4.6 7.4.7 7.4.8 7.4.9 7.4.10

Configuring the software for specific users ...150 Configuring the 14-function foot control panel ... 150 Configuring the handgrips... 152 Configuring image inversion on the Invertertube E ... 153 Configuring the direction of the XY coupling... 153 Configuring speeds... 154 Configuring the speed of the RESIGHT 700 internal focus... 154 Configuring the overhead display ... 154 Configuring fast focus ... 155 Configuring links ... 156 Configuring reset options ... 156

7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.5.6 7.5.7 7.5.8 7.5.9 7.5.10 7.5.11

Daily operation ...157 Setting the illumination ... 158 Setting the total magnification ... 162 Setting the focus distance ... 163 Setting DeepView... 164 Changing the XY coupling position ... 164 Setting the integrated keratoscope ring... 165 Setting the HD Digizoom ... 166 Setting the integrated HD camera ... 166 Recording... 170 Transferring control to CALLISTO eye ... 179 Ending control via CALLISTO eye ... 180

7.6 7.6.1

Typical operating sequence ...181 Starting work ... 181

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7.6.2 7.6.3

Carrying out the working steps... 182 Stopping work ... 183

7.7

Switching the device off ...183

8

Cleaning and disinfection ...185

8.1

Safety during cleaning and disinfection...185

8.2 8.2.1 8.2.2 8.2.3 8.2.4

Cleaning ...185 Cleaning optical surfaces ... 185 Cleaning the touchscreen ... 186 Cleaning mechanical surfaces ... 186 Fogging of optical surfaces... 186

8.3 8.3.1

Disinfection ...187 Disinfecting the mechanical surfaces ... 187

9

Maintenance ...189

9.1

Maintenance schedule for the operator...189

9.1.1

Every six months... 189

9.2 9.2.1 9.2.2 9.2.3

Maintenance schedule for the authorized service...189 Every twelve months ... 189 Every two years ... 190 Every four years... 190

9.3

Performing safety inspections ...192

10

Troubleshooting...193

10.1 10.1.1 10.1.2

Localizing malfunctions ...193 Response to faults with messages ... 193 Exporting log files... 194

10.2

Faults (with messages) ...194

10.3 10.3.1 10.3.2 10.3.3 10.3.4

Faults (without messages) ...195 Device faults... 195 Integrated video and image recording faults... 199 14-function foot control panel faults ... 199 Wired 14-function foot control panel faults... 201

10.4 10.4.1 10.4.2 10.4.3 10.4.4 10.4.5 10.4.6 10.4.7

Troubleshooting work ...202 Activating manual mode... 202 Operating the device in manual mode ... 203 Changing the halogen lamp ... 204 Swiveling the backup xenon lamp into position and resetting the remaining service hours ... 205 Changing the Superlux Eye light source lamp module... 206 Displaying the firmware versions ... 208 Opening the service menu ... 208

11

Technical specifications...209

11.1

Essential performance features ...209

11.2

Regulatory information ...209

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11.3

Bluetooth module...209

11.4 11.4.1 11.4.2 11.4.3 11.4.4 11.4.5

Electrical data...210 Stand ... 210 Light sources ... 210 Integrated HD camera ... 211 Integrated HD video and image recording ... 212 Integrated keratoscope ring ... 213

11.5 11.5.1 11.5.2

Mechanical data ...213 Integrated slit illumination ... 213 Integrated 22" monitor ... 213

11.6 11.6.1 11.6.2 11.6.3 11.6.4

Optical data...214 Surgical microscope... 214 Objective lenses... 214 Objective lenses with support ring... 214 Eyepieces ... 214

11.7 11.7.1 11.7.2 11.7.3 11.7.4

Dimensions and weights...215 Dimensions and swiveling ranges ... 215 Support arm system ... 216 Maximum weight capacity... 217 Total weight... 217

11.8

Ambient requirements for operation ...217

11.9

Ambient requirements for transport and storage ...218

11.10

Guidance and manufacturer´s declaration – electromagnetic immunity...218

11.10.1 Electromagnetic disturbance emissions... 220 11.10.2 Electromagnetic immunity for all ME equipment and ME systems... 221 11.10.3 Electromagnetic immunity for non-life-supporting ME equipment and ME systems... 222

12

Accessories and components ...223

12.1

Accessories ...223

12.1.1 12.1.2 12.1.3 12.1.4 12.1.5 12.1.6

Fundus viewing systems ... 223 Additional illumination ... 223 Products that can be reprocessed (sterilization) ... 223 Drapes... 224 CALLISTO eye ... 224 Video accessories ... 224

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

Components ...225 14-function foot control panel ... 225 Tubes for surgical and assistant's microscopes... 225 Eyepieces for surgical and assistant's microscopes ... 225 Intermediate pieces for surgical microscope ... 225 Objective lenses... 226 Coobservation ... 226 Integrated components (factory installed)... 226 Lamps and light guides... 227 Dust cover... 227 Network cable... 227 Country-specific power cable... 227

12.3

UC kits ...228

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13

Decommissioning ...229

13.1

Safety during decommissioning...229

13.2 13.2.1

Cleaning before storage ...229 Cleaning the device and accessories ... 229

14

Packaging and transport...231

14.1

For your information ...231

15

Disposal ...233

15.1

Environmental pollution ...233

15.2

Disposal of the device...233

Glossary ...235 Index ...239

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Instructions for Use OPMI Lumera 700

1 Notes on the instructions for use 1.1 Device name

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

1.2 Area of application These Instructions for Use apply to OMPI Lumera 700 with Software Release 3.2 and the following identification: • Reference number: 6726 (OPMI Lumera 700)

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.

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

Instructions for Use OPMI Lumera 700

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. 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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Instructions for Use OPMI Lumera 700

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)

YES

Instructions for Use

CALLISTO eye Panel PC (model II)

YES

Instructions for Use

CALLISTO eye Basic Functions

YES

Instructions for Use

CALLISTO eye - Software Add-On for Assistance Functions

Yes

Instructions for Use

CALLISTO eye - Software Add-On for OMPI Lumera 700 control

YES

Instructions for Use

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

YES

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Instructions for Use OPMI Lumera 700

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.

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

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.

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2 Safety notes 2.2 Area of use

Instructions for Use OPMI Lumera 700

2.2.4 Normal use 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 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. In order for the physician and other personnel to continue viewing, additional video equipment can be installed on the device. 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.

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Instructions for Use OPMI Lumera 700

2 Safety notes 2.3 Responsibilities and duties of the operator

2.2.5 Patient target group 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

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 [} 19]

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.

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u

Comply with the specified time limits.

u

Perform the inspections to the prescribed extent.

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2 Safety notes 2.3 Responsibilities and duties of the operator

Instructions for Use OPMI Lumera 700

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 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.

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2 Safety notes 2.4 Measures and duties of the operator

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.

2.4 Measures and duties of the operator Electrical safety u

Always switch off the device before connecting it to or disconnecting it from the power supply, for cleaning its surface, or if it will not be used for a prolonged period of time.

u

Only connect the device to a power supply that complies with the values specified on the rating label.

u

Do not use multiple sockets!

u

Do not use extension cables!

u

Do not touch the device if your body is electrostatically charged and the device is not grounded.

u

Connect the device via the potential equalization connection (according to IEC 60601-1) to other active devices with the same ground potential or connect it to a protective ground connection.

u

Please observe the information on electromagnetic compatibility (EMC).

The device contains freely accessible live components. If you remove the housing, you run the risk of electric shock. u

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Never open the device!

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2 Safety notes 2.5 Electromagnetic compatibility

Instructions for Use OPMI Lumera 700

Environmental conditions u

Make sure that the installation conditions and the operation of the device comply with the surgical requirements:

• Low vibration • Clean environment • Avoid extreme mechanical stress u

Do not use power-operated devices included in the delivery package

• in explosive atmospheres, • at a distance of less than 25 cm from flammable anesthetics or volatile solvents such as alcohol, benzine or similar substances. u

Do not use or store the device in damp rooms. Do not expose the device to water splashes, dripping water or sprayed water.

u

Ensure that fluids cannot enter the device.

Symbols and labels u

Note the symbols and labels attached to the device!

Transport u

Only transport the device over long distances (e.g. relocation, return for repair) in its original packaging or special return packaging.

u

Please contact your dealer or ZEISS Service for this purpose.

2.5 Electromagnetic compatibility The device is subject to special precautionary measures regarding electromagnetic compatibility (EMC). The following factors can cause EMC disturbances: • Portable and mobile HF communication equipment in the vicinity of the device. • Other devices set up in the vicinity or stacked together with the device. • Accessories, cables and spare parts not specified in the Instructions for Use and not sold by ZEISS as spare parts.

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