Zeiss VISULAS green User manual

VISULAS green
Documentation set

Copyright
© 2018, Carl Zeiss Meditec AG, Jena
Trademarks
VISULAS® , ClearView® , Spotview® , InsightViewTM and
TouchControlTM are trademarks or registered trademarks of
Carl Zeiss Meditec AG or other members of the ZEISS Group in
Germany and/or other countries.
All other trademarks mentioned in this document are the property
of their respective owners.

Documentation set Table of contents
VISULAS green
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Table of contents
1 Notes on 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 Conventions in this document ..............................................................................................7
1.5.1 Conventions in all text areas..............................................................................................................7
1.5.2 Conventions in a course of action......................................................................................................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 Intended use .....................................................................................................................................9
2.2.2 Patient population.............................................................................................................................9
2.2.3 Indications.......................................................................................................................................10
2.2.4 Side effects and contraindications ...................................................................................................10
2.2.5 Complications .................................................................................................................................11
2.3 Responsibilities and duties of the responsible organization ...............................................12
2.3.1 Notification to manufacturers and authorities..................................................................................13
2.4 Measures and duties of the operator..................................................................................14
2.5 Risk from incoherent optical radiation ...............................................................................15
2.6 Hazard due to coherent laser radiation ..............................................................................16
2.6.1 General information ........................................................................................................................16
2.6.2 Safety officer...................................................................................................................................16
2.6.3 Laser hazard area ............................................................................................................................17
2.6.4 Laser safety goggles / eye patches...................................................................................................17
2.6.5 Patient safety ..................................................................................................................................18
2.6.6 Danger caused by direct irradiation and reflection...........................................................................18
2.7 Risk of fire ..........................................................................................................................19
2.8 Damage to fiber optics .......................................................................................................19
2.9 Maintenance measures.......................................................................................................19
3 Description of the device............................................................................ 21
3.1 Package check list ..............................................................................................................21
3.1.1 VISULAS green version for endocoagulation ....................................................................................21
3.1.2 VISULASgreen version with LSLgreenclassic laser slit lamp ............................................................21
3.1.3 VISULASgreen version with LSLgreencomfort laser slit lamp .........................................................21
3.1.4 VISULAS green version with VISULINK 532/U ..................................................................................22
3.2 Markings on the system .....................................................................................................22
3.3 System structure.................................................................................................................26

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3.3.1 System configuration.......................................................................................................................26
3.3.2 System overview..............................................................................................................................27
3.3.3 LSL green laser slit lamp ..................................................................................................................28
3.4 Controls, display elements and connectors.........................................................................30
3.4.1 Laser console...................................................................................................................................30
3.4.2 Control panel (TouchControl panel) .................................................................................................31
3.4.3 LSL green comfort laser slit lamp .....................................................................................................33
3.4.4 LSL green classic laser slit lamp........................................................................................................36
3.4.5 Standard foot switch .......................................................................................................................38
3.4.6 TouchControl foot switch................................................................................................................39
3.5 Functional description ........................................................................................................40
3.5.1 Safety systems.................................................................................................................................40
4 Installation ................................................................................................. 43
4.1 Installation safety ...............................................................................................................43
4.2 Connecting .........................................................................................................................44
4.3 Mounting the foot switch on the foot of the instrument table...........................................45
4.4 Moving the instrument table with the devices....................................................................46
5 Daily startup............................................................................................... 47
5.1 Preparation safety ..............................................................................................................47
5.2 Switching on ......................................................................................................................47
6 Operation................................................................................................... 49
6.1 Operation safety.................................................................................................................49
6.2 Operation with laser slit-lamp ............................................................................................50
6.2.1 Adjusting the slit lamp and eyepieces ..............................................................................................50
6.2.2 Positioning the contact lenses .........................................................................................................51
6.2.3 Laser treatment with laser slit lamp .................................................................................................51
6.3 Operation with laser endoprobes .......................................................................................52
6.3.1 Connecting the laser endoprobe......................................................................................................52
6.3.2 Laser treatment with the laser endoprobe .......................................................................................53
6.4 Switching off the system ....................................................................................................54
7 Software description.................................................................................. 55
7.1 Overview ............................................................................................................................55
7.2 On-screen keyboard............................................................................................................56
7.3 "Configure" work step........................................................................................................56
7.4 "Prepare" work step...........................................................................................................57
7.4.1 Single-spot mode ............................................................................................................................58
7.4.2 Multi-spot mode (optional)..............................................................................................................60
7.5 “Treat” work step...............................................................................................................63
7.5.1 Single-spot mode ............................................................................................................................63
7.5.2 Multi-spot mode (optional)..............................................................................................................65

Documentation set Table of contents
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7.6 "Document" work step.......................................................................................................67
7.7 Settings ..............................................................................................................................69
7.7.1 General ...........................................................................................................................................70
7.7.2 Treatments......................................................................................................................................71
7.7.3 Contact lenses.................................................................................................................................78
7.7.4 System information and DEMO mode..............................................................................................80
7.7.5 Maintenance ...................................................................................................................................82
8 Cleaning and disinfection ........................................................................... 83
8.1 Safety when cleaning and disinfecting the device ..............................................................83
8.2 Cleaning .............................................................................................................................83
8.3 Disinfection ........................................................................................................................84
9 Maintenance .............................................................................................. 85
9.1 Testing electrical safety ......................................................................................................85
9.2 Perform safety inspections .................................................................................................88
9.3 Replacing the halogen bulb in the laser slit lamp ...............................................................88
9.4 Replacing the fuse ..............................................................................................................89
9.5 Replacing the light-emitting diode (LED) of the fixation lamp (optional) ............................90
10 Troubleshooting......................................................................................... 93
10.1 Faults (with messages) .......................................................................................................93
10.2 Faults (no messages)...........................................................................................................94
10.3 Service information ............................................................................................................94
11 Technical specifications.............................................................................. 95
11.1 Risk-relevant performance features of clinical functions ....................................................95
11.2 Compliance.........................................................................................................................95
11.2.1 Guidelines with which the system is compliant ................................................................................95
11.2.2 The device fulfills the requirements of the following standards ........................................................95
11.2.3 System classification........................................................................................................................95
11.2.4 RoHS Conformity.............................................................................................................................95
11.3 VISULAS green laser system ...............................................................................................96
11.4 LSL green laser slit lamp.....................................................................................................97
11.5 Ambient conditions ............................................................................................................98
11.6 Electromagnetic compatibility ............................................................................................98
11.6.1 Ambient conditions for intended use...............................................................................................98
11.6.2 Restriction on clinical functions .......................................................................................................98
11.6.3 Guidelines and manufacturer's electromagnetic compatibility declaration......................................100
12 Optional accessories and spare parts ....................................................... 103
12.1 Instrument table...............................................................................................................105

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12.2 Laser endoprobes .............................................................................................................105
12.3 Connect the door contact isolator to the laser console.....................................................107
12.4 Physician's safety filter .....................................................................................................107
13 Disposal of the sytem............................................................................... 109
14 References ............................................................................................... 111
Glossary ................................................................................................... 113
Keyword index ......................................................................................... 115

Documentation set 1 Notes on Instructions for Use
VISULAS green 1.1 Product name
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1 Notes on 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 classic, laser
console with single port)
• Reference number: 2096-102 (VISULASgreen comfort, 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.
uRead these instructions for use before starting and using the
system.
uKeep the instructions for use where they are accessible at all
times for all users.
uPass the instructions for use on to the next owner of the
system.
1.4 Questions and comments
uIf you have any questions or comments concerning these
instructions for use or the system, please 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.

1 Notes on Instructions for Use Documentation set
VISULAS green1.6 Applicable documents
8 / 116 000000-2096-101-DokS-GB-181218
This is a cross-reference: Questions and comments [}7].
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.
uThis is a measure with which hazards can be prevented.
CAUTION! This is warning information about hazards that can cause
injuries if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
NOTE This is warning information about hazards that can cause
property damages if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
þThis 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.
ðThis is the result of a sequence of actions.
1.6 Applicable documents
Please also refer to the instructions for use for additional compo-
nents and accessories to be used with this device.

Documentation set 2 Safety notes
VISULAS green 2.1 Intended user profile
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2 Safety notes
2.1 Intended user profile
This system may only be installed, operated, used and maintained
by persons who have the necessary training, knowledge and
experience. Please adhere to the additional national qualification
guidelines applicable in your country.
Persons who operate the system must have a basic knowledge of
ophthalmic examination, diagnosis methods and therapeutic lasers
in ophthalmology.
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.
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
The VISULASgreen is intended for use in photocoagulating ocular
tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina
• Trabeculoplasty for treatment of glaucoma
• Iridotomy for treatment of glaucoma
2.2.2 Patient population
If the respective clinical indications [}10] are present and
contraindications [}10] are excluded, the therapeutic laser
treatment can, in principle, be performed on patients of all age
groups.
The average patient undergoing retinal surgery with the
VISULASgreen is between 40 and 80 years old, suffers from
diabetic retinopathy resulting from diabetes mellitus type II, is able
to sit on a chair (or wheelchair), has stable fixation and no disorder
that limits his/her movements (e.g. bedridden patients) or his/her
ability to assume a calm and stable position / fixation over a period
of 10to15 minutes.
uLaser treatment of the following patient groups with the
VISULASgreen and laser slit lamp applicator should be avoided:

2 Safety notes Documentation set
VISULAS green2.2 Intended field of application
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• Patients who are unable to sit upright in front of the device,
• Patients who have difficulty in keeping their head still against
the forehead and chin rest for a few minutes while sitting
upright (e.g. due to vertebral complaints, or in the case of
seriously overweight patients, pregnant women),
• Patients with forehead or chin injuries that prevent the head
from being supported on the forehead rest and chin rest,
• Patients who are unable to comply with the instructions of the
attending physician (e.g. children under the age of 12).
2.2.3 Indications
Photocoagulation
• Retinal diseases that result in vascular proliferation due to
retinal ischemia, e.g. proliferative diabetic retinopathy, vascular
occlusions
• Macular edema, e.g. diabetic macular edema
• Chorioretinal neovascularization
• Retinal foramen and retinal degeneration with imminent
detachment
• Open angle glaucoma (ALT)
2.2.4 Side effects and contraindications
Photocoagulation [1] [}111], [2] [}111], [3] [}111], [4]
[}111], [5] [}111]
Side effects:
• Experience of pain and discomfort
• Enlargement of an existing macular edema
• Macular inflammatory reaction
• Blind spots / limitation of peripheral vision
• Enlargement of laser burn (scarring) with associated loss of
visual acuity
• Impaired dark adaptation
• Increased light sensitivity
• Impaired color vision
• Subretinal choroidal neovascularizations
• Choroidal effusion
Contraindications:
• Strong clouding of the anterior ocular media (e.g. of the lens
due to a dense cataract) and of the vitreous body (e.g. due to
severe vitreous body bleeding)

Documentation set 2 Safety notes
VISULAS green 2.2 Intended field of application
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The 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 literature,
professional associations and the legislation applicable in your
country.
2.2.5 Complications
Photocoagulation [1] [}111], [2] [}111], [3] [}111], [4]
[}111], [5] [}111]
• Unintentional coagulation spot (e.g. in the fovea)
• Initial, usually non-fully reversible reduction of visual acuity
(with PRP)
• Epiretinal gliosis
• Macular edema (reversible)
• Spontaneously reversible exudative retinal/choroid amotio
• Retinal hemorrhage / choroidal hemorrhage when laser power
set too high
• Shrinkage of fibrinous strands
• Clouding of the lens
Notes
uAlways use a suitable contact lens for retinal photocoagulation.
uAvoid laser treatment if the patient underwent fluorescence
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 at this time 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 can lead to the physician
being dazzled.
uDo not use the VITE multi-spot option for patients who are
unable to fixate steadily (e.g. in the event of nystagmus,
tremor, Parkinson's, epilepsy, extremely poor eyesight, inability
to concentrate).
The complications are not limited to the list above. For further
information on a comprehensive list of complications consult the
relevant literature, professional associations and the legislation
applicable in your country.

2 Safety notes Documentation set
VISULAS green2.3 Responsibilities and duties of the responsible organization
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2.3 Responsibilities and duties of the responsible
organization
Operating personnel
The system may only be operated by instructed and trained
personnel.
uEnsure that the operating personnel have been trained and
instructed.
uEnsure that the operating personnel have read and understood
the instructions for use.
uThe instructions for use should be readily accessible to the
operating personnel at all times.
uTo facilitate access for the entire operating personnel: If
necessary, request further copies of the instructions for use
from ZEISS.
uDefine the required skills for handling the system and provide
information on who is authorized for which activities.
uDefine rules for reporting errors and damage, and provide
information on this to all operating personnel (see Section
Notification to manufacturers and authorities [}13]).
uProvide the required protective equipment.
uRegularly check compliance with the national laws and regula-
tions concerning accident prevention and occupational health.
Safety inspections
See also chapter Perform safety inspections [}88].
uTo 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.
Safety inspections may be carried out only by the manufacturer or
by persons authorized by the manufacturer.
uKeep within the prescribed deadlines.
uPerform 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 power

Documentation set 2 Safety notes
VISULAS green 2.3 Responsibilities and duties of the responsible organization
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• 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
12,000 power-on hours, assuming that the system is operated and
maintained as prescribed by the manufacturer.
Maintenance and inspection
uTo 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.
Accessories and additional equipment
uIf you want to connect accessories or additional equipment to
the system: Contact ZEISS [}7].
Additional equipment connected to medical electrical systems must
comply with the corresponding IEC or ISO standards (e.g.
IEC60950 for data processing equipment).
Furthermore all configurations must comply with the normative
requirements for medical electrical systems (see IEC60601-1-1).
If you connect additional devices to medical electrical systems, you
are responsible for ensuring that the system complies with the legal
and normative requirements for systems.
2.3.1 Notification to manufacturers and authorities
If an incident occurs in connection with this medical device wich
affects the responsible organization or another person, the respon-
sible organization (or person responsible) must report this incident
to the manufacturer or seller of the medical product. In some
countries (e.g. the European Union) the responsible organization
must report this incident to the responsible authorities in the appli-
cable country.

2 Safety notes Documentation set
VISULAS green2.4 Measures and duties of the operator
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2.4 Measures and duties of the operator
Electrical safety
uSwitch the system off every time before disconnecting it from
the power supply or if you are not going to use the device for
any length of time. Also disconnect the system from the power
supply before cleaning surfaces or accessories.
uInsert the power plug only into a power outlet that has a
functioning protective earth connection.
uUse only cables and plugs which are in perfect working
condition.
uConnect the laser console only to a power supply that corre-
sponds to the values specified on the rating plate.
uDo not use multiple sockets!
uDo not use extension cables!
uDo not touch the system when your body is charged electro-
statically and the system is not grounded.
uObserve the instructions regarding electromagnetic compati-
bility (EMC).
uSet the system up so that the power cable can be disconnected
from the power supply quickly and without any supplementary
means.
uConnect 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.
uPerform 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).
uDo 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.
uNever open the system!
Ambient conditions
uMake sure that the installation requirements and the operation
of the system meet the following requirements:
• Low vibration
• Clean environment
• Avoid extreme mechanical loads
uDo not operate the supplied devices, provided that they are
energetically operated,

Documentation set 2 Safety notes
VISULAS green 2.5 Risk from incoherent optical radiation
000000-2096-101-DokS-GB-181218 15 / 116
• on easily inflammable materials,
• in explosion risk areas (e.g. combustible mixture of anesthetic,
cleaning or disinfecting agents with air, oxygen or nitrous
oxide).
uDo not store or use this system in damp areas. Do not expose
the system to water splashes, dripping or sprayed water.
uEnsure that no liquids can enter the system.
Decommissioning
uIf 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 the 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
uObserve the symbols and labels attached to the system.
Transport
uTransport the system over long distances (e.g. move, return for
repair, etc.) only in original packaging or special return
packaging.
uContact your dealer or ZEISS Service.
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 Safety notes Documentation set
VISULAS green2.6 Hazard due to coherent laser radiation
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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 operator
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 trigger 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 distal end of the laser beam delivery
system is not visible, is weak or appears diffuse, it may indicate
damage to or improper function of the applicator.
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 atten-
dance 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

Documentation set 2 Safety notes
VISULAS green 2.6 Hazard due to coherent laser radiation
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2.6.3 Laser hazard area
The laser hazard area should be as small as possible and demar-
cated 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.
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.
The patient's eye which is not being treated must also be properly
protected.
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.

2 Safety notes Documentation set
VISULAS green2.6 Hazard due to coherent laser radiation
18 / 116 000000-2096-101-DokS-GB-181218
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 (laser
fluence) at the target, 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 energy density (laser fluence) is always displayed on the user
interface of the VISULASgreen. Following a change in contact lens
or spot diameter, ensure that the value for energy density is the
same as prior to the change.
The power or energy level on the VISULASgreen can be varied.
If, after using an applicator (e.g. LIOVISULASgreen), you change
to a different applicator (e.g. slit lamp), the correct 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.
2.6.6 Danger caused by direct irradiation and reflection
The system and its applicators emit visible laser radiation which is
dangerous to the human eye and skin.
As an application device the LIO VISULASgreen laser indirect
ophthalmoscope may only be operated together with the
VISULASgreen laser console and not with 532 nm lasers of third
party suppliers.
Strictly avoid irradiation of the eye or skin by direct or scattered
radiation. Metallic and similar surfaces reflect laser beams.
All persons present in the laser hazard area must wear protective
goggles as a precaution against unintentional direct or reflected
radiation.
Remove any bright, reflecting objects from the laser range or cover
them. Also cover windows and reflecting walls with non-
combustible cloths.
Take safety precautions if there is a risk of noxious gases, dust and
vapors, secondary radiation or explosive gas mixtures from
materials exposed to laser radiation within the laser hazard area.
Only use medical instruments in the laser beam path which are
shaped or surface-finished to prevent hazardous reflection.

Documentation set 2 Safety notes
VISULAS green 2.7 Risk of fire
000000-2096-101-DokS-GB-181218 19 / 116
2.7 Risk of fire
Do not use the laser in conjunction with flammable anesthetic
substances.
Keep potentially explosive materials away from the laser hazard
zone. Easily flammable materials may start fires.
A laser beam could ignite many explosive or flammable gases or
liquids, including some of the solutions used in the preparation of
surgical procedures.
Flammable drapes, surgical gowns, gauze and other ignitable
materials must be kept out of the beam path. We recommend
using non-flammable materials and instruments and wearing
gowns and clothing which do not easily catch fire.
A fire extinguisher should be kept in the vicinity of the system.
Check the integrity of all lenses and glass surfaces before each use.
Severe contamination may result in unwanted heat exposure.
Detached coatings may result in exposure to increased radiation.
2.8 Damage to fiber optics
Fiber optics may not be tightly bent, kinked or incompletely
secured. The system may otherwise be damaged and injury caused
to the patient or user.
2.9 Maintenance measures
Maintenance procedures (maintenance and repairs) which are not
specified in these instructions for use may only be carried out by
persons authorized by Carl Zeiss Meditec and solely according to
the service instructions issued by Carl Zeiss Meditec. For planning
and implementing these maintenance and care procedures please
contact ZEISS Service or your local dealer.

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