User Manual
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VISULAS green
Documentation set
Copyright © 2022, Carl Zeiss Meditec AG, Jena Brands VISULAS®, ClearView®, SpotView®, InsightViewTM and TouchControlTM, 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 green
Table of Contents
Table of Contents 1
Notes on the instructions for use ...
7
1.1
Product name ...
7
1.2
Scope of application ...
7
1.3
Purpose and storage of the documentation ...
7
1.4
Questions and comments ...
7
1.5 1.5.1 1.5.2
Conventions in this document ... Conventions in all text areas... Conventions in a course of action...
7 7 8
1.6
Applicable documents ...
8
2
Safety notes ...
9
2.1
Intended user profile ...
9
2.2
Intended field of application...
9
2.2.1 2.2.2 2.2.3 2.2.4 2.2.5
Intended use ... Clinical benefits ... Patient population... Indications... Side effects and contraindications ...
9 10 10 11 11
2.3
Responsibilities and duties of the responsible organization ...
13
2.3.1
Notification to manufacturers and authorities...
15
2.4
Measures and duties of the operator...
16
2.5
Risk from incoherent optical radiation ...
18
2.6 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6
Hazard due to coherent laser radiation ... General information ... Safety officer ... Laser hazard area ... Laser safety goggles / eye patches... Patient safety ... Danger caused by direct irradiation and reflection ...
18 18 19 19 20 20 21
2.7
Risk of fire ...
21
2.8
Damage to fiber optics ...
21
2.9
Maintenance measures...
22
3
Description of the device... 23
3.1 3.1.1 3.1.2 3.1.3 3.1.4
Package check list ... VISULAS green version for endocoagulation ... VISULAS green version with LSL green classic laser slit lamp ... VISULAS green version with LSL green comfort laser slit lamp ... VISULAS green version with VISULINK 532/U ...
23 23 23 23 24
3.2
Markings on the system ...
25
3.3
System structure...
29
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Documentation set VISULAS green
3.3.1 3.3.2 3.3.3
System configuration... System overview... LSL green laser slit lamp ...
29 30 31
3.4 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6
Controls, display elements and connectors... Laser console... Control panel (TouchControl panel) ... LSL green comfort laser slit lamp ... LSL green classic laser slit lamp... Standard foot switch ... TouchControl foot switch ...
33 33 35 37 41 43 44
3.5 3.5.1
Functional description ... Safety systems...
45 46
4
Installation ... 47
4.1
Installation safety ...
47
4.2
Connecting ...
48
4.3
Mounting the foot switch on the foot of the instrument table...
49
4.4
Moving the instrument table with the devices...
50
5
Daily startup... 51
5.1
Preparation safety ...
51
5.2
Switching on ...
51
6
Operation ... 53
6.1
Operation safety...
53
6.2 6.2.1 6.2.2 6.2.3
Operation with laser slit-lamp ... Adjusting the slit lamp and eyepieces ... Positioning the contact lenses ... Laser treatment with laser slit lamp ...
55 55 56 56
6.3 6.3.1 6.3.2
Operation with laser endoprobes ... Connecting the laser endoprobe... Laser treatment with the laser endoprobe ...
57 57 58
6.4
Switching off the system ...
59
7
Software description ... 61
7.1
Data security ...
61
7.2
Overview ...
62
7.3
On-screen keyboard...
63
7.4
"Configure" work step...
63
7.5 7.5.1 7.5.2 7.5.3
"Prepare" work step... Single-spot mode ... Multi-spot mode (optional)... Selective mode (optional) ...
65 65 67 71
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7.6 7.6.1 7.6.2 7.6.3
“Treat” work step... Single-spot mode ... Multi-spot mode (optional)... Selective mode (optional) ...
75 75 78 80
7.7
"Document" work step ...
83
7.8
Settings ...
85
7.8.1 7.8.2 7.8.3 7.8.4 7.8.5
General ... Treatments ... Contact lenses... System information and DEMO mode... Maintenance ...
86 87 94 96 98
8
Cleaning and disinfection ... 99
8.1
Safety when cleaning and disinfecting the device ...
8.2
Cleaning ... 100
8.3
Disinfection ... 100
9
Maintenance ... 101
9.1
Testing electrical safety ... 101
9.2
Perform safety inspections ... 104
9.3
Replacing the halogen bulb in the laser slit lamp ... 105
9.4
Replacing the fuse ... 106
9.5
Replacing the light-emitting diode (LED) of the fixation lamp (optional) ... 107
10
Troubleshooting... 109
10.1
Faults (with messages) ... 109
10.2
Faults (no messages)... 110
10.3
Service information ... 110
11
Technical data... 111
11.1
Risk-relevant performance features of clinical functions ... 111
11.2
System classification... 111
11.3
VISULAS green laser system ... 111
11.4
LSL green laser slit lamp... 113
11.5
Ambient conditions ... 113
11.6 11.6.1 11.6.2 11.6.3
Electromagnetic compatibility ... 114 Ambient conditions for intended use... 114 Restriction of clinical functions ... 114 Guidelines and manufacturer's electromagnetic compatibility declaration... 116
12
Optional accessories and spare parts ... 119
12.1
Instrument table ... 121
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12.2
Laser endoprobes ... 122
12.3
Connect the door contact isolator to the laser console... 124
12.4
Physician's safety filter ... 125
13
Disposal of the system ... 127
14
References ... 129 Glossary ... 131 Index ... 133
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1 Notes on the instructions for use 1.1 Product name
1 Notes on the instructions for use 1.1 Product name VISULAS green is referred to as "system" in these instructions for use.
1.2 Scope of application The present instructions for use apply to VISULAS green with the following marking: •
Reference number: 2096-101 (VISULAS green single port, laser console with single port)
•
Reference number: 2096-102 (VISULAS green dual port, laser console with dual port)
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 webpage: 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 [} 7]. This is highlighted text.
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1 Notes on the instructions for use 1.6 Applicable documents
Documentation set VISULAS green
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.
Prerequisite
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 also refer to the instructions for use for additional components and accessories to be used with this device.
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2 Safety notes 2.1 Intended user profile
2 Safety notes 2.1 Intended user profile This system may only be installed, operated, used and maintained by persons who have been properly trained or who have the required knowledge and experience to do so. Please also adhere to the national qualification guidelines applicable in your country. Persons who operate the system must have knowledge of basic examination, diagnosis methods and therapeutic lasers in ophthalmology. Zeiss recommends that persons who are new to this treatment technique familiarize themselves thoroughly with the procedure. Persons working in the laser hazard area must be familiarized at least once a year with safety regulations, safety precautions and system operation. Keep a written record of these instructions, listing the participants. In general, the operator of a therapeutic laser is an ophthalmologist who is trained regarding the use of therapeutic lasers, i.e., not an optometrist, technician or assistant.
2.2 Intended field of application This system may only be set up, operated and used for the specified purpose and according to national regulations, consistent with the applicable industry standards and occupational safety and accident prevention regulations. The country-specific laser protection requirements must be adhered to.
2.2.1 Intended use VISULAS green is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. This includes: •
Photocoagulation of the retina
•
Trabeculoplasty for treatment of glaucoma
•
Iridotomy for treatment of glaucoma
VISULAS green is intended for use in Selective Laser Trabeculoplasty (SLT).
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2 Safety notes 2.2 Intended field of application
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2.2.2 Clinical benefits Treatment with the VISULAS green photocoagulation laser, including all components and accessories, offers a clinical benefit in the treatment of various eye diseases with the aim of preventing disease progression or averting severe vision loss. The treatment is aimed at patients with a wide range of diseases of the retina, choroid or trabecular meshwork. Compared to classical photocoagulation, the VITE option also offers patients and users faster treatment times, less treatment pain and less collateral damage to the retina.
2.2.3 Patient population If appropriate clinicalindications are given and contraindications are excluded, therapeutic laser treatment can in principle be performed in patients of all age groups. The safety and efficacy of the treatment method has not been established for children and adolescents.
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u
Avoid laser treatment with the VISULAS green and laser slit lamp applicator in the following patient groups:
•
Patients who are unable to sit upright in front of the device,
•
Patients who have difficulty in sitting upright for several minutes with the head resting on the forehead and chin rest (e.g., with intervertebral disc problems, severely obese patients, pregnant women),
•
Patients who have forehead or chin injuries that prevent the head from being supported on the forehead rest or chin rest.
•
Patients who are unable to follow the instructions of the attending physician
u
Be especially cautious about illuminance and illumination duration when examining premature infants, babies, toddlers, and aphakic patients.
u
Selective laser trabeculoplasty: Treat patients with strong pigmentation of the chamber angle only with very low energies (typically 10 μJ), since the frequency of short-term increase in intraocular pressure correlates with the degree of pigmentation. Treat only in the range of 90° and repeat the treatment in several steps if required. Consult the literature for recommended treatment procedures and concomitant medications.
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2 Safety notes 2.2 Intended field of application
2.2.4 Indications Photocoagulation •
Retinal diseases leading to vascular proliferation due to retinal ischemia, e.g., proliferative diabetic retinopathy, vascular occlusion
•
Macular edema, e.g. diabetic macula edema
•
Chorio-retinal neovascularization
•
Retinal foramen and retinal degeneration with impending detachment
•
Open-angle glaucoma (ALT)
•
Acute angle closure glaucoma (iridotomy)
Selective laser trabeculoplasty •
Primary open-angle glaucoma
2.2.5 Side effects and contraindications Contraindications The use of the device is potentially contraindicated for the following indications: Retinal photocoagulation, iridotomy and laser trabeculoplasty (ALT) •
Strong clouding of the anterior ocular media (e.g. of the lens due to a dense cataract) or of the vitreous body (e.g. due to severe vitreous body bleeding) such that the target area cannot be clearly identified
Selective laser trabeculoplasty •
Acute angle closure glaucoma if the trabecular meshwork is not sufficiently visible
•
Neovascular glaucoma
•
Acute inflammatory glaucoma
•
Veins in Schlemm's canal
Objective evaluation of patients eligible for these procedures must be performed with consideration, of the risks and contraindications, and weighing the potential desirable and undesirable effects. Side effects Retinal photocoagulation •
Ocular pain
•
Disorders of accommodation
•
Vision disturbances (e.g. night vision deficits, photophobia)
•
Visual impairment (e.g. visual field defects, blind spots)
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2 Safety notes 2.2 Intended field of application
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•
Ocular hypertension
•
Disorders of choroid and retina (e.g. detachment, hemorrhage, photocoagulation scar) following surgery
Iridotomy and laser trabeculoplasty (ALT) •
Ocular pain
•
Visual disturbances (e.g. dysphotopsia, blurred vision)
•
Ocular hypertension
•
Disorders of cornea (e.g. edema, endothelial change)
•
Anterior chamber hemorrhage
•
Iridocyclitis
•
Disorders of iris and ciliary body (e.g. peripheral anterior synechiae, iris atrophy)
•
Corneal scars and opacities
•
Traumatic cataract
Selective laser trabeculoplasty (SLT) •
Ocular pain
•
Vision disturbances (e.g. photophobia)
•
Ocular hypertension
•
Disorders of cornea (e.g. inflammation, endothelial change)
•
Anterior chamber hemorrhage
•
Iridocyclitis
•
Disorders of iris and ciliary body (e.g. synechiae, pigment dispersion)
•
Disorders of conjunctiva (e.g. hyperaemia, subconjunctival haemorrhage)
•
Disorders of retina (e.g. macula edema)
Notes
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u
Always use the correct contact lens for laser treatment.
u
Avoid laser treatment if the patient underwent fluorescein angiography on the same day prior to laser treatment. Because the fluorescein injected into the patient takes several hours before it is completely broken down, yellow light flashes may be emitted during treatment with a 532 nm laser wavelength, which are only partially blocked or not blocked at all by the physician's safety filter and may lead to the physician being dazzled.
u
Do not use the VITE multi-spot option in patients who are not capable of steadily fixating (e.g. in the case of nystagmus, tremor, Parkinson's disease, epilepsy, extremely poor visual acuity, lack of concentration).
u
Do not use the SLT option on the retina.
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2 Safety notes 2.3 Responsibilities and duties of the responsible organization
Side effects and contraindications are not limited to the list above. For further information on a comprehensive list of side effects and contraindications, please consult the relevant medical literature, professional associations and the legislation applicable in your country.
2.3 Responsibilities and duties of the responsible organization Patient education Explain to the patient the nature, scope, implementation, expected consequences and risks of the measure as well as its necessity, urgency, suitability and chances of success with regard to the therapy. When providing information, alternatives to the measure must also be pointed out if several medically equally indicated and common methods can lead to significantly different types of stress and risk or prospects of a cure. Please also observe the respective national regulations regarding the obligation to inform patients. To inform patients, use educational materials from providers that are approved in your country or certified to ISO 13485. Operating personnel The system 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
The instructions for use should be readily accessible to the operating personnel at all times.
u
To facilitate access for the entire operating personnel: If necessary, request further copies of the instructions for use from ZEISS.
u
Define the required skills for handling the system and provide information on who is authorized for which activities.
u
Define rules for reporting errors and damage, and provide information on these (see Section Notification to manufacturers and authorities [} 15]).
u
Provide the required protective clothing.
u
Regularly check compliance with the national laws and regulations concerning accident prevention and occupational health.
Safety inspections See also Section Perform safety inspections [} 104]. u
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To prevent any reduction in system safety due to aging and wear: Have regular safety inspections performed which are set in accordance with the applicable national regulations for this system.
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2 Safety notes 2.3 Responsibilities and duties of the responsible organization
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Safety inspections may be carried out only by the manufacturer or persons authorized by the manufacturer. u
Keep within the prescribed intervals.
u
Perform the inspections to the prescribed extent.
The following safety inspections should be performed as a minimum for the system: •
Check the presence of the instructions for use
•
Visual inspection of the system and its accessories for damage, as well as legibility of markings and labels
•
Leakage current test
•
PE conductor check
•
Calibration of laser energy
•
Check the ventilation slits of the system. They should not be covered or obstructed.
•
Functional check of all switches, buttons, connectors and control lamps on the system
Service life The development, production and maintenance of this system, and also the associated risks, are based on an expected service life of 12000 power-on hours, assuming that the system is operated and maintained as prescribed by the manufacturer. Maintenance and inspection u
To ensure safe operation of the system and to reach the expected service life: Observe the maintenance and inspection intervals that are specified in these instructions for use.
Changes to the product Modifications to the product or failure to follow the manufacturer's instructions may substantially reduce the expected service life and significantly increase the risks associated with the use of this system and are thus not permitted. Data protection and information security
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•
The user or IT manager must ensure compliance with national data protection laws and regulations.
•
The responsible organizations of IT systems and IT networks are responsible for defining the required security standards, i.e. for creating the required technical and organizational parameters.
•
Abuse occurs when protected personal data is collected, processed or used in any other way without the appropriate permission.
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2 Safety notes 2.3 Responsibilities and duties of the responsible organization
Please note the following definitions: •
Personal data: All information relating to the personal or material circumstances of an identified or identifiable person. All data that can be directly assigned to a person (patient, employee, customer, supplier) (e.g. marital status, employment relationship, religious affiliation, income) must be protected.
•
Data processing: The storage (input, recording or storage), transfer (transmission to third parties outside the organization), modification (fundamental changes, including anonymization and pseudonymization), deletion (removal) and blocking (marking to restrict further processing or use) of data.
•
Use: The use of data (e.g. for company internal transmission).
•
Receivers: Persons or entities receiving data.
•
Third parties: Persons or entities that do not belong to the responsible entity (legal entity). The transmission of data to third parties is regarded as data transmission.
Accessories and additional equipment u
If you want to connect accessories or additional equipment to the system: Contact your ZEISS contact [} 7].
Additional equipment connected to medical electrical equipment must comply with the corresponding IEC or ISO standards (e.g. IEC 62368-1 for data processing equipment). In addition, all configurations must meet the standard requirements for medical electrical systems (see IEC 60601-1). If you connect additional devices to medical electrical systems, you are a system configurer and are thus responsible for ensuring that the system complies with the legal and normative requirements for systems.
2.3.1 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 must report this incident to the manufacturer or seller of the medical product. In member states of the European Union, the operator, responsible organization, or person must report serious incidents to the competent authority. In all other countries, comparable rules apply where national legislation so requires.
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2 Safety notes 2.4 Measures and duties of the operator
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2.4 Measures and duties of the operator Electrical safety u
Switch the system off every time before disconnecting it from the power supply, or if you are not going to use the system for any length of time. Also disconnect the system from the power supply before cleaning surfaces or accessories.
u
Insert the power plug only into a power outlet that has a functioning protective earth connection.
u
Use only cables and plugs which are in perfect working condition.
u
Connect the laser console only to a power supply that corresponds to the values specified on the rating plate.
u
Do not use multiple sockets!
u
Do not use extension cables for power supply!
u
Do not touch the system if your body is charged electrostatically and the system is not grounded.
u
Observe the instructions regarding electromagnetic compatibility (EMC).
u
Set the system up so that the power cable can be disconnected from the power supply quickly and without any supplementary means.
u
Connect the laser console using the power cable intended for use with the laser console. If the laser console is mounted on an IT 1060.i / IT 760.i instrument table, it will be powered through this table.
u
Perform the electrical installation in conformance to IEC 60364-7-710 or the applicable national regulations. This includes the integration of a ground fault circuit interrupter (GFCI).
u
Do not touch the patient and the connections of the system simultaneously.
Live parts are accessible inside the system. If you remove the housing, you are exposed to the risk of an electric shock. u
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Never open the system!
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2 Safety notes 2.4 Measures and duties of the operator
Ambient conditions u
Make sure that the installation requirements and the operation of the system meet the following requirements:
•
Low vibration
•
Clean environment
•
Avoid extreme mechanical loads
u
Do not operate the supplied devices under power,
•
on easily inflammable materials,
•
in explosion risk areas (e.g. combustible mixture of anesthetic, cleaning or disinfecting agents with air, oxygen or nitrous oxide).
u
Do not store or use this system in damp areas. Do not expose the system to water splashes, dripping water or sprayed water.
u
Ensure that no liquids can enter the system.
Decommissioning u
If one of the following events should occur, disconnect the cable from the power supply, label the system clearly as being out of service and report the problem to ZEISS Service:
•
Electric shocks
•
Penetration of substances
•
Frequently occurring error messages
•
Faults that cannot be remedied based on the information provided in these instructions for use
Symbols and labels u
Observe the symbols and labels attached to the system.
Transport u
Transport the system over long distances (e.g. move, return for repair etc.) only in original packaging or special return packaging.
u
Contact your dealer or ZEISS Service.
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2 Safety notes 2.5 Risk from incoherent optical radiation
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2.5 Risk from incoherent optical radiation Because prolonged intense light exposure can damage the retina, the use of LSL green or LIO VISULAS green for ocular examination should not be unnecessarily prolonged, and the brightness settings should not exceed what is needed to provide clear visualization of the target structures. The halogen or LED light emitted from these devices is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from these devices when operated at maximum output will exceed the safety guideline after 8 min (filter position: white). If you have any questions concerning permissible longer exposure times with other filter positions, please contact ZEISS service. When operating the devices, avoid looking directly into the light emitting prism. Take particular care when examining infants and aphakic patients. Never look into the sun through the binocular tube and eyepieces.
2.6 Hazard due to coherent laser radiation 2.6.1 General information This system is a class 4 laser device. For this reason, the responsible organization must take precautions to prevent injuries or damage. Applicable national and international regulations must be observed. Use the lowest possible power necessary to achieve the desired effect. Focus the aiming beam as carefully as possible on the tissue to be treated. Never fire the laser if the aiming beam is not clearly visible in the target area. Deactivate the therapy beam and always switch the aiming beam off before changing the applicator or releasing the applicator fibers from the laser module for any other reason. Please note that incorrect disconnection of the fiber optic cable when the laser is in operation may result in a brief discharge of scattered radiation to the surroundings. Switch the aiming beam off when the system is not in use. Because the aiming beam follows the same optical path through the beam delivery system as the therapy beam, it represents a good method for checking that the beam delivery system is undamaged. If the aiming beam spot at the laser exit aperture is not visible, is weak or appears diffuse, it may indicate damage to or improper function of the applicator.
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2 Safety notes 2.6 Hazard due to coherent laser radiation
2.6.2 Safety officer The operator and safety officer are responsible for carrying out all safety measures to prevent injury to the patient, physician in attendance and other persons present during laser operation. Observe the national regulations in your country. The responsibilities of the safety officer, who is appointed in writing by the responsible organization, include: •
Implementation of safety measures
•
Instruction of all persons working with the laser in safety precautions and correct operation of the system
•
Marking of the laser hazard area
•
Checking the warning signs and equipment
•
Correct therapeutic application of the system
•
Safekeeping of the key for the key switch
•
Safekeeping of the system
•
Proper reconnection of the system after relocation
2.6.3 Laser hazard area The laser hazard area should be as small as possible and demarcated by suitable screens. Unauthorized persons should be prevented from entering the laser hazard area. The number of persons in the laser hazard area must be kept to a minimum. Where suitable screens are not in use, the entire treatment room must be considered as a laser hazard area. A laser warning lamp must be installed at the entrance door indicating when the laser is in operation. The ZEISS laser warning lamp should preferably be used. The supplied remote door interlock switches the laser off automatically when the door to the laser area is opened to gain access. If a laser warning light from a third-party supplier is used, the door interlock may only be used in conjunction with the door contact isolator. The laser hazard area must be clearly demarcated and marked as such during the entire laser operation. Other safety precautions should be clarified with local authorities or with your laser safety officer. Only the patient and appropriately trained personnel may remain within the laser hazard area. These persons must wear suitable laser safety goggles when the laser is in operation. Persons working in the laser hazard area must be given instruction concerning safety regulations, safety precautions and operation of the system at least once a year. Keep a written record of these instructions, listing the participants. All objects within the laser hazard area, including the floor, should have diffusely reflecting surfaces or be covered with diffusely reflecting material.
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2 Safety notes 2.6 Hazard due to coherent laser radiation
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2.6.4 Laser safety goggles / eye patches All persons present in the laser hazard area during the laser operation must wear laser safety goggles. The laser hazard area is the area in which the maximum permissible exposure (MPE) may be exceeded. This includes areas into which the laser beam may unintentionally be deflected by a reflecting surface. When using a monocular assistant's scope, the second eye must be covered by an eye patch during laser treatment. Exception: The physician does not require laser safety goggles when observing the target area through •
a surgical microscope equipped with a 532 nm physician's safety filter
•
a ZEISS laser slit lamp or
•
the LIO VISULAS green laser indirect ophthalmoscope.
The responsible organization is responsible for providing proper laser safety goggles. The safety goggles must be approved for the wavelength of the laser and for the type and intensity of the laser radiation in your country. Laser safety goggles for VISULAS green: 532 D LB5
2.6.5 Patient safety The key parameter in laser treatment is the energy density at the target (laser fluence), i.e. applied laser energy divided by the area of the laser spot. In order to achieve a consistent physiological effect, the power/energy should therefore be adjusted when the spot diameter is changed. The value of the energy density (laser fluence) is always displayed on the user interface of the VISULAS green. After changing the contact lens or changing the spot diameter (not possible in selective mode), make sure that the energy density corresponds to the value before the change. The power or energy can be varied on the VISULAS green. If, after using an applicator (e.g. LIO VISULAS green), you change to a different applicator (e.g. slit lamp), the correct new applicator must be selected from the main menu. Never start treatment if a different applicator is shown in the display to the one required, or if no physician's safety filter is fitted. Do not fire the laser beam if the tip of the laser endoprobe is touching the tissue.
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