VISULAS User Manual

Copyright © 2023, Carl Zeiss Meditec AG, Jena Brands VISULAS®, ClearView®, SpotView®, InsightView® and TouchControl®, 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 trademarks in this document are the property of their respective owners.

Documentation set VISULAS

Table of Contents

Table of Contents 1

Notes on the instructions for use ...

9

1.1

Product name ...

9

1.2

Scope of application ...

9

1.3

Purpose and storage of the documentation ...

10

1.4

Questions and comments ...

10

1.5 1.5.1 1.5.2

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

10 10 11

1.6

Applicable documents ...

11

2

General safety instructions... 13

2.1

Intended use...

13

2.2

Intended user profile ...

13

2.3

Clinical benefits ...

13

2.4

Patient population...

13

2.5

Indications ...

13

2.6

Contraindications ...

13

2.7

Warnings ...

13

2.8

Precautions...

14

2.8.1 2.8.2 2.8.3 2.8.4 2.8.5 2.8.6 2.8.7

General information ... Installation notes ... Instructions for daily startup ... Instructions for shutting down ... Reprocessing instructions (cleaning and disinfection) ... Instructions on maintenance ... Notification to manufacturers and authorities...

14 15 18 18 19 19 20

2.9

Side effects...

20

3

Description of VISULAS green ... 21

3.1 3.1.1 3.1.2 3.1.3 3.1.4

Package check list ... Software licenses, accessories and options ... Device configurations with laser slit lamps... LIO VISULAS green ... VISULAS green device configuration with endoprobes...

21 21 23 24 24

3.2 3.2.1 3.2.2 3.2.3 3.2.4

External labels ... VISULAS green laser console (single port and dual port) ... LSL green comfort / classic laser slit lamp ... LIO VISULAS green ... Foot switch ...

25 25 27 28 30

3.3 3.3.1

Device configuration... LSL green laser slit lamp ...

31 33

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3.3.2 3.3.3

LIO VISULAS green ... Endoprobes ...

35 37

3.4 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6 3.4.7

Controls, display elements and connectors... Laser console... Control panel (TouchControl panel) ... LSL green comfort laser slit lamp ... LSL green classic laser slit lamp... LIO VISULAS green ... Standard foot switch ... TouchControl foot switch ...

38 38 40 43 49 51 57 58

3.5 3.5.1 3.5.2 3.5.3 3.5.4

Functional description ... Green laser for photocoagulation ... LSL green comfort / classic laser slit lamp ... LIO VISULAS green ... Endoprobes ...

59 59 60 60 62

4

Description of VISULAS yag ... 63

4.1

Package check list ...

63

4.1.1 4.1.2

Software licenses, accessories and options ... Device configuration for VISULAS yag with laser slit lamp...

63 64

4.2 4.2.1 4.2.2 4.2.3

External labels ... VISULAS yag laser console... LSL yag laser slit lamp... Foot switch ...

65 65 67 68

4.3 4.3.1

Device configuration... LSL yag laser slit lamp...

69 71

4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5

Controls, display elements and connectors... YAG laser console ... Control panel (TouchControl panel) ... LSL yag laser slit lamp... Standard foot switch ... TouchControl foot switch ...

72 72 73 74 76 76

4.5 4.5.1 4.5.2

Functional description ... Infrared laser for photodisruption... LSL yag laser slit lamp...

76 76 78

5

Description of VISULAS combi ... 81

5.1 5.1.1 5.1.2 5.1.3

Package check list ... Software licenses, accessories and options ... VISULAS combi device configuration with LSL green combi laser slit lamp ... LIO VISULAS green ...

81 81 83 83

5.2 5.2.1 5.2.2 5.2.3

External labels ... VISULAS combi laser console... LSL green combi laser slit lamp... Foot switch ...

84 84 86 87

5.3 5.3.1

Device configuration... LSL green combi laser slit lamp...

88 90

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Table of Contents

5.3.2

LIO VISULAS green ...

91

5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7

Controls, display elements and connectors... VISULAS combi laser console... Control panel (TouchControl panel) ... LSL green combi laser slit lamp... LIO VISULAS green ... Endoprobes ... Standard foot switch ... TouchControl foot switch ...

92 92 93 94 96 96 96 96

5.5

Functional description ...

96

6

Installation ... 97

6.1

Installation safety ...

97

6.2

Installation of LIO VISULAS green ...

97

6.2.1 6.2.2

Connecting... Mounting the charging dock to the wall (optional)...

97 98

6.3

Moving the instrument table with the devices...

99

7

Daily startup... 101

7.1

Daily inspection ... 101

7.2

Switching on and routine tests ... 102

8

Shutting down ... 103

8.1

VISULAS system with laser slit lamp... 103

8.2

VISULAS system with LIO VISULAS green... 104

8.3

VISULAS system with laser endoprobe ... 104

9

Cleaning and disinfection ... 105

9.1

General information ... 105

9.2

Cleaning of VISULAS... 105

9.3

Disinfection of VISULAS... 106

9.4

Cleaning of optical components of VISULAS... 107

9.5 9.5.1 9.5.2 9.5.3

Treating contact lenses... 107 Cleaning... 107 Disinfection ... 108 Sterilizing ... 108

9.6 9.6.1 9.6.2 9.6.3

Treating ophthalmoscope lenses ... 109 Cleaning... 109 Disinfection ... 109 Sterilizing ... 109

10

Maintenance and care... 111

10.1

Safety inspection ... 111

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11

Troubleshooting... 115

11.1

Faults (with messages) ... 115

11.2 11.2.1 11.2.2 11.2.3 11.2.4

Faults (no messages)... 120 Replacing the fuse ... 121 Replacing the light-emitting diode... 122 Replacing the LED in LIO VISULAS green... 123 Change batteries in LIO VISULAS green or insert new battery ... 124

11.3

Service information ... 125

12

Disposal of the system ... 127

13

Technical specifications... 129

13.1

Risk-relevant performance features of clinical functions ... 129

13.2 13.2.1 13.2.2 13.2.3 13.2.4

Technical data of VISULAS green ... 129 Single Port / Dual Port laser console ... 129 LSL green comfort / classic laser slit lamp ... 130 LIO VISULAS green ... 131 Endoprobes ... 132

13.3

Technical data of VISULAS yag ... 133

13.4

Technical data of VISULAS combi ... 135

13.4.1 13.4.2 13.4.3 13.4.4

Laser console combi ... LSL green combi laser slit lamp... LIO VISULAS green ... Endoprobes ...

13.5

Ambient conditions ... 138

13.6

Electromagnetic compatibility ... 138

13.6.1 13.6.2 13.6.3

Ambient conditions for intended use... 138 Restriction on clinical functions ... 139 Guidelines and manufacturer's electromagnetic compatibility declaration... 141

14

Optional components and accessories ... 145

14.1

Instrument table ... 147

14.2

VISUCONNECT 600 ... 147

14.3

Panel-PC (SL Workstation) ... 148

14.4

SL Imaging Solution... 150

14.5

AT 030... 150

14.6

Doorlock isolator ... 151

14.7

Power cable... 151

15

References ... 153

135 136 137 137

Appendix: NOHD calculation ... 155 LSL yag laser slit lamp and LSL green combi ... 156

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LSL green classic and comfort laser slit lamps ... 158 Endoprobes ... 160 LIO VISULAS green ... 161

Glossary ... 163 Index ... 165

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Documentation set VISULAS

1 Notes on the instructions for use 1.1 Product name

1 Notes on the instructions for use 1.1 Product name VISULAS green, VISULAS yag and VISULAS combi are referred to in these instructions for use as "system". In the following, when statements or references apply equally to all models, we will refer simply to "VISULAS".

1.2 Scope of application The present instructions for use apply to the VISULAS consoles and laser applicators with the following marking: •

Reference number: 2222-001 (Single Port, laser console with one optic fiber port)

•

Reference number: 2222-002 (Dual Port, laser console with two optic fiber ports)

•

Reference number: 2222-003 (Combi, laser console with two optic fiber ports)

•

Reference number: 2222-004 (YAG, laser console without an optic fiber port)

•

Reference number: 2039-606 (LSL green classic)

•

Reference number: 2039-607 (LSL green comfort)

•

Reference number: 2039-608 (LSL green combi)

•

Reference number: 2039-609 (LSL yag)

•

Reference number: 2222-000 (LIO VISULAS green)

and laser endoprobes which are approved for VISULAS. NOTE! These instructions for use describe the maximum configuration and maximum functionality. You may find that some configurations or functionalities are not available in your country. Please contact our regional representatives for more information. Subject to changes in design and scope of delivery, and to ongoing technical development.

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1 Notes on the instructions for use 1.3 Purpose and storage of the documentation

Documentation set VISULAS

1.3 Purpose and storage of the documentation These instructions for use explain the safety features, functions and the performance parameters of the system. They are a guide for safe operation and specify the measures for maintenance and repair of the system. The correct operation of the system is vital for safe and successful operation. Action

u

Read these instructions for use before starting and using the system.

u

Keep the instructions for use where they are accessible at all times for all users.

u

Pass the instructions for use on to the next owner of the system.

1.4 Questions and comments Action

u

If you have any questions or comments concerning these instructions for use or the system, please contact ZEISS Service.

You can find the ZEISS representative for your country online 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 [} 10]. This is highlighted text. 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:

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•

[START] key

•

[Next] button

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Documentation set VISULAS

1 Notes on the instructions for use 1.6 Applicable documents

1.5.2 Conventions in a course of action This is warning information about hazards that can cause death or severe injuries if not avoided.

WARNING!

The warning message names the possible consequences. u

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause injuries if not avoided.

CAUTION!

The warning message names the possible consequences. u

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause property damages if not avoided.

NOTE

The warning message names the possible consequences. u

Prerequisite

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.

1.6 Applicable documents Please observe also the software descriptions and enclosed quick guides of the associated licenses as well as the instructions for use of other components and accessories used with this device. Please check at regular intervals whether a newer version of these instructions for use is available at http://www.zeiss.com/ifu.

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2 General safety instructions 2.1 Intended use

2 General safety instructions 2.1 Intended use The intended use is contained in the software description supplied depending on the configuration.

2.2 Intended user profile The intended user profile is contained in the software descriptions supplied depending on the configuration.

2.3 Clinical benefits The clinical benefits for a treatment with the VISULAS depend on the clinical application and are therefore included in the software descriptions supplied depending on the configuration.

2.4 Patient population If appropriate clinical Indications [} 13] are given and Contraindications [} 13] are excluded, therapeutic laser treatment can in principle be performed in patients of all age groups. You will find further information in the software descriptions supplied depending on the configuration.

2.5 Indications The indications depend on the clinical application and are therefore included in the software descriptions supplied depending on the configuration.

2.6 Contraindications The contraindications depend on the clinical application and are therefore included in the software descriptions supplied depending on the configuration.

2.7 Warnings General and application-specific warnings are included in the respective software descriptions.

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2 General safety instructions 2.8 Precautions

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2.8 Precautions 2.8.1 General information

14 / 166

u

The system may only be installed, operated, used and maintained by persons who have the appropriate training or knowledge and experience. Please also adhere to the national qualification guidelines applicable in your country.

u

Report an incident or near incident to the medical device manufacturer or distributor in a timely manner. Observe local laws for additional reporting to competent authorities.

u

Note the software descriptions and information accompanying the accessories, additional devices, optional parts and consumables.

u

Make sure that persons who use the device or are in the laser area have been instructed on the behavior to be observed and the use of the system.

u

Designate and authorize a laser safety officer to provide the necessary training and ensure that protective measures are maintained in the laser area.

u

Instruct users once a year about the special hazards of laser radiation and about the safety equipment of the device which is not operated regularly (e.g. laser emergency stop device).

u

Carry out daily inspection measures according to the information given in Daily inspection [} 101].

u

USA only: United States national law prohibits the physician from selling this device directly or through a third party.

u

Pay attention to the following safety notice for the head strap (material number: 306883-0000-000): CAUTION! This product contains natural rubber latex which may cause allergic reactions.

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Documentation set VISULAS

2 General safety instructions 2.8 Precautions

2.8.2 Installation notes 2.8.2.1 General information u

Installation, instruction and commissioning shall only be performed by the manufacturer or by companies authorized by the manufacturer. WARNING! Do not modify this equipment without authorization of the manufacturer.

u

The instructions for use should be readily accessible to the operating personnel at all times.

u

Only connect devices, accessories and detachable parts authorized by the manufacturer or designated in these instructions for use. Contact your ZEISS contact partner for an up-to-date list. WARNING! Only use accessories, transformers and cables which are specified or provided by the manufacturer for this device. The use of alternative parts may result in higher electromagnetic emissions or reduced immunity of the device and thus in faulty operation.

2.8.2.2 Structural requirements and positioning of the device

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u

Install and operate the system in accordance with the ambient and connection conditions contained in the technical data (see Technical specifications [} 129]).

u

Operate the device only in rooms suitable for class 4 lasers according to IEC 60825-1.

u

Only operate the device in an environment where no conductive contamination can occur.

u

Install a fire extinguisher in the vicinity of the device.

u

Set the device up so that the power cable can be disconnected from the power supply quickly and without any supplementary means.

u

Keep the laser area as small as possible in terms of space within the specified task.

u

Ensure that the emitted laser beam passes outside the working and traffic area in as small an area as possible that is not easily accessible. In particular, the emitted laser beam must pass above or below eye level.

u

Ensure that the laser hazard area is clearly demarcated and marked as such during laser operation. Laser operation must be indicated by laser warning lights at the access to laser areas.

u

Only use third-party laser warning lights if the electrical connection is sufficiently insulated (at least 4 kV AC).

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u

In rooms intended for laser operation, ensure that the floors, ceiling, walls and other structural elements have diffusely reflecting surfaces. Suitable non-flammable covers should be provided for bare surfaces such as windows.

u

Ensure by technical or organizational measures that exposure above the maximum permissible irradiation, also by reflected or scattered laser radiation, is prevented.

u

Make sure that the laser beam - as far as possible - is limited by a diffusely reflecting target surface in such a way that a hazard due to direct or diffuse reflection is minimized. For example, align the system so that the laser exit aperture is not aimed at the entrance door of the treatment room.

u

Ensure that optical devices used to observe the surgical field are equipped with suitable laser protection filters if the maximum permissible irradiation can be exceeded.

u

Set up the device including components and accessories located in the laser beam path in such a way that an unintentional change of their position and the beam direction is avoided.

u

Do not operate the electrical devices contained in the delivery package:

•

in explosive atmospheres,

•

on easily inflammable materials,

•

in the presence of inflammable anesthetics or volatile solvents, such as alcohol, benzene or similar,

•

in oxygen-enriched environments.

2.8.2.3 Electrical safety and electromagnetic compatibility WARNING! To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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u

Ensure that a ground fault circuit interrupter (GFCI) and an adequate overcurrent protection are installed.

u

Do not use multiple sockets and / or extension cables.

u

Connect the device using the power cable intended for use with the device and matching the local wall connection.

u

When the device is combined with other electrically powered devices, the requirements of IEC 60601-1 must be taken into account.

u

Perform the electrical installation in conformance to IEC 60364-7-710 or the applicable national regulations.

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Documentation set VISULAS

2 General safety instructions 2.8 Precautions

u

Do not use portable HF communications equipment (including peripheral devices such as antenna cable and external antennas) within a radius of 30 cm around the VISULAS, including cables specified by the manufacturer. Otherwise, deterioration in the performance is to be anticipated.

u

Do not use the device in locations where the electromagnetic interference level is higher than specified in the technical data, see Electromagnetic compatibility [} 138].

u

Ensure that multimedia or IT equipment connected to the device via signal lines complies with the requirements of CISPR 32.

WARNING! Avoid using the device in direct proximity to other devices, or stacked together with other devices, as this could result in faulty operation. If it is nonetheless necessary to operate the device in the aforementioned manner, the device and the other devices should be monitored to ensure the safety of the arrangement used. 2.8.2.4 IT networks u

Note that if the system is integrated into an IT network and the patient treatment data are combined, undesired modification of the treatment data or unauthorized use of patient data with associated treatment data is possible.

u

Perform risk management according to IEC 80001-1 when integrating the system into an IT network.

u

Note that a reassessment of risks is required for the following changes in IT networks:

•

Changes to the IT network configuration

•

Connecting additional elements in the IT network

•

Removal of elements from the IT network

•

Updating or upgrading devices connected to the IT network

2.8.2.5 Data security u

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Protect the system and patient data from unauthorized use. Please also observe the nationally applicable laws and regulations for the protection of sensitive data.

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2.8.3 Instructions for daily startup u

Remove the dust cover when connecting the device to the supply mains.

CAUTION! When lowering the instrument table, always ensure that no body parts are within the movement range of the tabletop. u

Avoid the penetration of liquids. Except for the foot switch, the device does not provide protection against the ingress of liquids.

2.8.4 Instructions for shutting down

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u

Disconnect the system from the power supply if you are not going to use the system for any length of time.

u

When not in use, remove the key switch from the system to prevent its use by unauthorized persons.

u

Place the protective cap on the optical fiber if the device is not in use.

u

Pull the dust cover over the device after disconnecting it from the power supply to reduce exposure to dust.

u

In the following cases, take the system out of operation and notify ZEISS Service of any required repair measures:

•

Unexpected change of laser energy / power or laser position

•

Electric shock

•

Penetration of liquids

•

Occurrence of smoke, fire or burning odor

•

Disimprovement of the system performance

•

Recurring error messages

•

Response of the system in contradiction with the information in these instructions for use

•

Safety-relevant deviation as a result of inspection measures

•

System related incidents or near incidents that (may) have resulted in injury to the patient or physician (user).

u

In case of obvious defects, take the laser safety goggles or other protective filters out of operation. Examples of such defects are clearly visible changes to the protective filter (cracks, color changes, changes in light transmission) or faults in the mount or holder that impair protection against incident radiation from the side.

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Documentation set VISULAS

2 General safety instructions 2.8 Precautions

2.8.5 Reprocessing instructions (cleaning and disinfection) u

Allow cleaning agents and disinfectants containing flammable solutions to evaporate completely before using the device or emitting laser radiation.

u

Clean and disinfect the applied parts according to the specified procedure or according to another procedure recognized by professional associations before applying them on a patient.

u

Do not use spray cleaning or disinfection.

u

Clean accessible optics in case of contamination according to the specified procedure.

2.8.6 Instructions on maintenance

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u

No treatments may be performed on patients during the maintenance and repair work.

u

Maintenance measures not contained in these instructions for use shall be performed only by persons authorized by Carl Zeiss Meditec. Maintenance measures may only be carried out according to the service instructions issued by Carl Zeiss Meditec.

u

Perform safety checks at least every 2 years by the manufacturer or by personnel authorized by the manufacturer. If necessary, contact your ZEISS representative for an overview of the minimum content of the safety check.

u

Do not open the device housing.

u

Do not allow anyone to look into the laser exit aperture when the device is switched on, even if laser safety goggles have been put on. The radiation emitted at the laser exit aperture (including illumination of the applicators and aiming beam) exceeds the limits of the maximum permissible irradiation values for human eyes not being treated with laser radiation for therapy purposes.

u

Do not look directly into the laser beam which is scattered back by bright, reflective surfaces.

u

Do not point the laser beam at highly reflective surfaces (e.g. metal instruments).

u

Disconnect from the power supply before changing the fuse!

u

Only use fuses which meet the specifications given on the sign containing the fuse markings.

u

Switch the illumination of LIO VISULAS green off and let the LED cool down before replacing the LED.

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2 General safety instructions 2.9 Side effects

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2.8.7 Notification to manufacturers and authorities If a serious incident affecting the user, patient or another person occurs in connection with this medical device, the responsible organization or person responsible must report this incident to the manufacturer or seller of the medical product. In member states of the European Union, the responsible organization or person must report serious incidents to their competent authority. In all other countries, comparable rules apply where national legislation so requires.

2.9 Side effects The side effects during treatment with the VISULAS depend on the clinical application and are therefore included in the software descriptions supplied depending on the configuration.

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