P001 0053 Operator Manual V2-21

NAVILAS® Operator Manual
Contents
Copyright Notice.......................................................................5
Preface: About this Operator Manual.........................7

Target Audience......................................................................................7
Description of Device Variants...................................................................7
Manual Organization................................................................................8
Symbols used in this Document................................................................8
Chapter 1: Introducing Navilas®................................9

1.1 Intended Use & Indications...............................................................10
1.2 Contraindications, Warnings & Precautions..........................................10
1.3 Image – Plan – Treat........................................................................11
1.4 Navilas® Laser System User Interface Overview...................................14
Chapter 2: Safety & Regulatory Information............19

2.1 Classifications..................................................................................20
2.2 Regulatory Compliance and Standards................................................21
2.3 Installation & Repair.........................................................................21
2.4 Laser Safety Considerations..............................................................22
2.5 Laser Safety Eyewear.......................................................................23
2.6 Electrical Hazards............................................................................24
2.7 Location of Regulatory and other Labels..............................................25
Chapter 3: Installation.............................................29
3.1 Connecting Accessories.....................................................................30
3.2 Start Navilas® & Log On....................................................................31
3.3 Log Off & Shut Down........................................................................32
3.4 Move the Navilas® Laser System........................................................33
3.5 Emergency Laser Shutoff..................................................................33
Chapter 4: The Navilas® Workflow...........................35

4.1 Create or Select a Patient Record.......................................................36
4.2 Positioning Patient and System..........................................................38
4.3 Image and Image Review..................................................................42
4.4 Plan the Treatment...........................................................................46
4.5 Treat..............................................................................................51
Navilas® Operator Manual – Document Version 2.21 © 2013 OD-OS GmbH – July 2014
4 Contents
4.6 Report............................................................................................61
Chapter 5: User Interface Reference........................63

5.1 Image Gallery and Compare Mode......................................................64
5.2 Advanced Functions.........................................................................64
5.3 Plan Parameters...............................................................................67
5.4 Treatment Settings Ranges................................................................69
5.5 Export Data....................................................................................70
Chapter 6: Maintenance & Administration................71

6.1 Clean the Navilas® Laser System........................................................72
6.2 System Settings..............................................................................73
6.3 Access Key and Equipment Data........................................................75
6.4 Back Up of the Patient Database........................................................75
6.5 Restore the Patient Database.............................................................76
6.6 Maintenance....................................................................................76
6.7 Long Term Storage...........................................................................77
6.8 Disposal.........................................................................................77
6.9 Troubleshooting Guide......................................................................78
Appendix A: Appendix..............................................81
A.1 Specifications..................................................................................82
A.2 Compatible Accessories....................................................................88
A.3 Suggested Reading..........................................................................88
A.4 Acronyms and Abbreviations.............................................................89
Contact...................................................................................91
Copyright Notice
© 2012, OD-OS GmbH, All Rights Reserved.
The hardware and software design of the Navilas® Laser System is owned by OD-OS
GmbH and is protected by the Federal Republic of Germany copyright laws and
international treaty provisions.
This operator manual may not be copied in whole or in part or reproduced without the
written permission of OD-OS GmbH. Copying includes translation into another language
and transferring into other media. Permitted copies must carry the same proprietary
and copyright notices as were affixed to the original under the law.
OD-OS, the OD-OS logo, Navilas® and the Navilas® logo are trademarks, registered
trademarks or service marks of OD-OS GmbH in Germany and/or other countries.
All other trademarks are properties of their respective owners.
Please note that while every effort has been made to ensure that the information in
this document is accurate, the instructions, photos, figures, illustrations, tables,
specifications, and schematics contained herein are subject to change without notice.
For questions regarding the appropriate use of the Navilas® Laser System or concerning
any of the safety or operating instructions described in this operator manual, please
contact your Navilas® help desk at:
Company:
Name:
Phone:
Email:
In case of doubt whom to contact, please feel free to contact the Navilas® help desk
at the Navilas® manufacturer:
OD-OS GmbH
Warthestrasse 21
14513 Teltow
Germany
+49 3328 31282 100
[email protected]
www.od-os.com
OD-OS Inc.
6201 Oak Canyon Drive, Suite 200
Irvine, CA 92618
USA
July 2014; Document Version: 2.21
Article number: 102053 Operator Manual English
Preface
About this Operator Manual

This operator manual provides a summary of guidelines for the most common
applications. Please note that although these applications have received FDA and other
approvals, the Navilas® Laser System may not have received approval in every country.
In addition, we recommend referring to textbooks and current clinical literature for a
more comprehensive description of contemporary surgical laser techniques. For
additional information, see Suggested Reading on page 88.
OD-OS GmbH does not make recommendations regarding the practice of medicine. All
settings provided in this operator manual are meant only as guidelines. It remains the
sole responsibility of the operator to ensure that they establish the optimal settings
for each case that they treat or diagnose. Incorrect treatment settings can cause serious
tissue damage. Use extreme caution until a thorough understanding of the biological
interaction between the laser energy and tissue is certain. Individual treatment should
be based on clinical training, clinical observation of laser-tissue interaction, and
appropriate clinical endpoints. Treatment parameters can depend on a variety of factors
including the type of tissue to be treated, the intensity of the treatment desired, and
the individual pigmentation of targeted tissue. Therefore, it is recommended to use
the lowest acceptable treatment settings until the Navilas® Laser System’s capabilities
are familiar, and then gradually increase treatment settings until the desired tissue
effect is obtained. This operator manual provides a summary of guidelines for the most
common applications.
Target Audience
This operator manual is a reference guide for the Navilas® Laser System. Target readers
are clinicians, ophthalmologists, and/or technicians with professional training and
experience in the use of retina imaging and treatment equipment, and in diagnostic
interpretation of the images generated.
In this manual the term “operator” is used to refer to every person that uses the system,
including clinicians and ophthalmologists that use Navilas® for treatment applications
and technicians that perform imaging procedures. The term “treatment room personnel”
refers to all persons that assist during treatment or are present in the room when
treatment takes place.
Description of Device Variants

Navilas® Laser System will be available in the following Laser source configurations:
‣ Navilas® Laser System (ND:YVO4 laser source; 532nm; model GLM01)
8 About this Operator Manual
‣ Navilas® Laser System 532+ (semiconductor laser source; 532nm; laser model 2G
532)
‣ Navilas® Laser System 577+ (semiconductor laser source; 577nm; laser model 2G
577).
Manual Organization
This operator manual is organized into the following parts:
‣ Chapter 1 – Introducing Navilas on page 9 describes indications for use and includes
an overview of the user interface.
‣ Chapter 2 – Safety & Regulatory Information on page 19 lists the standards the
Navilas® adheres to.
‣ Chapter 3 – Installation on page 29 describes how to start, log in, shut down and
move the Navilas® Laser System.
‣ Chapter 4 – The Navilas Workflow on page 35 explains how to use the Navilas® Laser
System.
‣ Chapter 5 – User Interface Reference on page 63 provides details on available
parameter settings and menu options.
‣ Chapter 6 – Maintenance & Administration on page 71 outlines procedures for
archiving and backing up data and caring for the hardware.
‣ The Appendix on page 81 lists technical specifications and compatible accessories.
Symbols used in this Document

Terms that appear in the Navilas® Laser System user interface or have a special meaning
within the Navilas® Laser System appear in bold gray text.
Warning: The warning symbol is intended to alert the operator to important information concerning
dangers that could lead to serious injury or death.
Caution: The caution symbol is intended to alert the operator to important information concerning
dangers that could potentially harm the patient or operating personnel, or have unknown or unexpected
consequences or which could damage the laser system.
Note: This symbol is intended to alert the operator to important operating and maintenance
instructions.
Chapter
1
Introducing Navilas®
Topics
‣ Intended Use & Indications

‣ Contraindications, Warnings
& Precautions
‣ Image – Plan – Treat
‣ Navilas Laser System User
Interface Overview
10 Introducing Navilas®
1.1 Intended Use & Indications

The Navilas® Laser System is an ophthalmic laser integrated with a digital camera. The
Navilas® Laser System is indicated for use in photocoagulation and treatment of the
retina, iris and trabecular meshwork, as well as for capturing, displaying, storing and
manipulating images of the eye created using color, fluorescein angiography and infrared
imaging.
The Navilas® Laser System is for prescription use only.
1.2 Contraindications, Warnings & Precautions
1.2.1 Contraindications
Laser treatment is contraindicated when an appropriate procedure cannot be performed
safely, for example, when tissue targets cannot be visualized properly. Under such
circumstances, an important tissue structure adjacent to a target tissue might be
treated inadvertently. Corneal opacities, cataract formation, and vitreous hemorrhage
can interfere with the laser physician’s view of appropriate target structures.
For detailed information and recommendations regarding laser photocoagulation please
read clinical guidelines and papers, such as the ETDRS. For additional literature
recommendations, see Suggested Reading on page 88.
1.2.2 Warnings
Caution: The use of a laser system for an application is at a physician’s discretion except in cases
where the application has been contraindicated.
‣ Only appropriate tissue targets should be treated.
1.2.3 Precautions
The following precautions must be taken into account when using a laser for ophthalmic
procedures:
‣ Caution should be used when reducing laser spot size settings. Decreasing the spot
size by ½ (one half) increases power density by a factor of 4 (four), which may
cause undesired target tissue damage.
‣ Pigment density variation in the retina pigment epithelium (RPE) or other tissue
targets can increase the local absorption of laser light, increasing the temperature
that a particular laser power setting and spot size can produce. Operators should
decrease the power setting if they need to treat an area of increased pigmentation
or treat adjacent less-pigmented tissues if feasible and therapeutically equivalent.
Introducing Navilas® 11
‣ Tissue opacities may exist through which the laser beam must pass on its way to
target tissues. Laser light absorption by these opacities may cause inadvertent and
undesirable thermal damage to the tissues in which the opacities are located.
Opacities in a patient’s ocular media include, but are not limited to, mascara or face
powder in the corneal tear film, corneal scars, pigment or blood on the anterior or
posterior surfaces of the crystalline lens, and cataract formation. Debris should be
removed from the patient’s tear film prior to laser therapy. Vascular or vascularized
structures should be treated with caution, using treatment patterns and parameters
appropriate for the individual clinical problem.
1.2.4 Imaging Contrast Medium—Contraindications, Warnings

& Precautions
Fluorescein angiography is a diagnostic procedure for examining the circulation of the
target tissues in the eye. Sodium Fluorescein is the imaging contrast medium used in
this diagnostic test. After the fluorescein dye is injected, the patient’s skin may turn
yellowish for several hours. This color disappears as the kidneys filter the dye. Because
the kidneys remove the dye, the patient’s urine will turn dark orange for up to 24 hours.
Some individuals may experience slight nausea during the procedure, but this usually
passes within a few seconds. Care must be taken to avoid extravasation of the dye
during the injection as localized burning and yellow staining of the skin may occur.
1.3 Image – Plan – Treat

The Navilas® Laser System was designed to improve the workflow of the laser treatment
of macula edema by the use of navigation. With Navilas®, retina laser treatment is
based on continuous fundus color imaging and realized in three consecutive steps:
Image – Plan – Treat. In the first step (Image), color images of the retina as well
as infrared and angiography images are taken. These images serve as the basis for
subsequent planning of the treatment (Plan) by the physician. The Treatment Plan is
placed onto the fundus image as a live overlay and stabilized against eye movements
during therapy (Treat). The combined steps and the integration of navigation allows
for complete and detailed documentation (Report).
1.3.1 The Navilas® Imaging Principle

The Navilas® Laser System combines the principles of two well-known and proven
ophthalmology devices: The slit lamp and the scanning laser ophthalmoscope (SLO).
Advanced digital sensor technology and digitally-designed optics now make it possible
to combine the capabilities of these two devices in a single integrated system.
Using image sensors and automated slit movement, Navilas® improves upon the imaging
modality of a slit lamp. In a conventional slit lamp, the operator moves the slit
illumination across the retina, much like a flashlight in the dark, thus mentally creating
a full retinal image from the discrete, observed slit images. Navilas® uses image sensors
and computerized slit movement to automate this process.
In addition, the Navilas® Laser System implements confocal imaging technology, similar
to an SLO. Using confocal imaging, Navilas® not only records high-definition (HD) and
high-contrast, reflex-free fundus images, but it also minimizes light scatter often
encountered with opaque media.
Note: In patients with high myopia, however, a moon-shaped reflex might appear centrally in the
image.
Unlike conventional SLO technology, the Navilas® Laser System can acquire
high-definition fundus images in real-time using state-of-the-art illumination and
imaging technologies. The optical design also allows for the integration of a
photocoagulation laser beam in such a way that reflections from the treatment-aiming
beam, which are very common in slit-lamp applications, are minimized.
The Navilas® Laser System’s color and infrared fundus imaging mode applies visible
light (VIS) and infrared light (IR), respectively, to the retina. Navilas® can also be used
to perform angiography using a narrow-band blue light to excite fluorescein dye injected
into a patient's blood.
1.3.2 Treatment Laser

The Navilas® Laser System may be equipped with one of the following laser modules:
A diode pumped frequency-doubled solid state Nd:YVO4 laser emitting 532 nm, a
semiconductor based laser emitting 532 nm or a semiconductor based laser emitting
577 nm. The laser cavities create laser radiation in the infrared range. This infrared
laser radiation is then transformed to visible laser radiation (green or yellow) using a
frequency-doubling element. The power of the visible laser can be adjusted by varying
the stimulating current of the laser diode. An integrated measuring system constantly
monitors and controls the delivered power output of the laser. For details, see Laser
Specifications on page 83 .
1.3.3 Treatment Modes

The Navilas® Laser System allows for two treatment modes:
‣ Navigated Treatment Mode
‣ Conventional Treatment Mode.
Conventional Treatment Mode is used to perform laser treatment with the same functions
as a slit lamp laser would provide. Navigated Treatment Mode supports additional
functionality, which are described in the following sections.
Only the Navigated Treatment Mode permits the use of invisible infrared light during
treatment. To aid in the evaluation of fluence on the retina, the Navilas® Laser System
supports the acquisition of a color snapshot during the treatment, which can be used
to correct and adapt the laser settings. This function is called Effect Evaluation.
1.3.4 Navigation Functions

The Navilas® Laser System combines all imaging for diagnostic purposes, treatment
planning and the treatment capabilities within the same platform. This combination
offers several functions that assist the operator throughout the treatment procedure
in order to obtain the best clinical results.
Navilas® includes the following navigation functions:
‣ Image Overlay
During laser treatment, a previously acquired image can be displayed as an overlay
superimposed onto the live image. This Navigation Function is called Image Overlay.
This is useful for locating defects such as micro aneurysms. During actual laser
application, the Image Overlay needs to be switched to 100% transparency.
‣ Plan Overlay (Treatment Locations & Exclusion Boundaries)
During the Plan workflow step, the operator can apply zones where laser application
shall be avoided (Exclusion Boundaries) and positions where the laser shall be
applied (Treatment Locations).
The Exclusion Boundaries can be visualized and overlaid onto the live image during
treatment. The Navilas® Laser System will block laser application in these areas.
Pre-Positioning within Exclusion Boundaries is not possible. Treatment Locations can
be visualized during treatment and used for positioning the laser.
‣ Pre-Positioning
A colored ring around the aiming beam (the Aiming Beam Marker) indicates the
current status of the laser application. The ring colors have the following meaning:
‣ Green: Laser application is possible, Pre-Positioning is active
‣ Red: The laser is releasing laser energy
In order to facilitate positioning of the aiming beam, the Navilas® Laser System
provides the Pre-Positioning Navigation Function, which directs the laser close to
the planned Treatment Location when a button is pressed and advances to the next
Treatment Location after an applied burn.
‣ Treatment Location Record
The Treatment Location Record Navigation Function assists in documenting the
treatment by indicating the positions where a laser has been applied. A circular
indicator (Treatment Location Marker) appears at or close to the position of the
aiming beam when the foot switch is pressed.
‣ Navigated Pattern
Patterns provide the ability to place a sequence of laser spots with a single press
of the foot switch. The Navilas® Laser System provides Planned Pattern and
Navigated Pattern.
The Planned Pattern is only available while processing a plan. Within these patterns
the spots will be applied spot-by-spot in a repeat mode method with an adjustable
pulse interval.
For applying a Navigated Pattern no plan is necessary. When applying a Navigated
Pattern the spots will be applied spot-by-spot in a repeat mode method with an
adjustable pulse interval. For a selected pulse interval of larger than 160ms, the
pulse duration can be selected freely without limitations and each spot will be
stabilized to the movements of the retina. Once the pulse interval is reduced to
“Fast” the pulse duration is limited to 30ms or less. Using this setting only the first
spot of the pattern will be stabilized.
‣ Infrared (IR) Treatment
The Infrared Treatment Mode is a Navigation Function that permits treatment in
infrared wavebands (IR) for a comfortable treatment of the retina as the use of
invisible light enhances patient cooperation.
1.4 Navilas® Laser System User Interface Overview

For a detailed description of the Navilas® Laser System workflow, see The Navilas
Workflow on page 35.
Some controls may be operated from both the device head and device base and in the
software to work comfortably with a hand-held treatment contact lens. In addition, the
Navilas® device head is symmetrically designed for optimal left- or right-handed use.
1.4.1 Navilas® Laser System Components
1. Device head; 2. Device base with joystick; 3. Height adjustable table; 4. Forehead and chinrest; 5.
Touch-sensitive digital display; 6. Electronic housing
Figure 1: Navilas® Laser System
The Navilas® Laser System includes the following components:

‣ Device head: These components allow for the all-in-one optimal adjustment and
positioning of the Navilas® for imaging and treatment. After correct patient and
system alignment, the patient’s gaze can be controlled via an external, illuminated
fixation target mounted on the headrest. Alternatively, different sections of the

fundus can be used via an angular movement in tilt (rotation around the x-axis) and
swing (rotation around the y-axis) using the handle located on the device head. The
device head contains the imaging elements and allows for laser beam delivery.
‣ Optical element: Interchangeable optical elements enable use with different
ophthalmic contact lenses. The optical elements can be attached and removed by
twisting the ring at the base of the element as described under Exchange optical
elements on page 38.
Note: Fluorescein Angiography is only available when using the standard optical element.
‣ Touch-sensitive digital display: The Navilas® Laser System is controlled primarily

via this digital display, which can be freely positioned around the table, according
to the operator's preference. The aiming beam position can be controlled by pointing
directly to the desired position on the touch-sensitive screen. A keyboard is also
available for patient data entry.
‣ Electronics housing: The electronics housing contains the laser engine, imaging
computer and control electronics.
‣ Table: Ergonomic height-adjustable table, which is wheelchair accessible and
incorporates a foot-area lamp for indirect illumination in (typically darkened)
treatment rooms. The table is fitted with wheels and height adjustment that allow
the Navilas® Laser System to be easily adjusted to the most comfortable position
for both patient and the operator.
Note: Height adjustment is not designed for continuous operation. After 2 minutes use 18 minutes
pause.
‣ Foot switch: Activates the treatment beam and releases laser energy.
‣ Device base and joystick: Similar to those found on standard slit lamps or other
ophthalmic devices, the device base and joystick are used to manually move the
device head in the x, y and z axes. The joystick is rotated to adjust the height of
the device head during various imaging or treatment situations, while the position
of the aiming beam is controlled using the trackball located on top of the joystick
(or via pen or finger on the touch-sensitive digital display). The joystick also contains
further elements such as those that control the Navigation Functions.
‣ Forehead and chinrest: The patient's head is stabilized by ergonomic chin and
forehead rests. For further patient comfort, the chin rest is height adjustable and
features robust grips which allow the patient to hold on with both hands during
imaging and treatment procedures.
1.4.2 The Navilas® Laser System Controls
1. Table elevation buttons; 2. Key switch; 3. Emergency laser off
Figure 2: Controls of table and electronics housing
1. Image acquisition; 2. Illumination control; 3. Imaging mode selection; 4. Base brake
Figure 3: Device head (operator-facing side)
1. Toggle button; 2. Two push buttons (left/right); 3. Trackball; 4. Scroll wheel
Figure 4: Joystick controls
1. Power down; 2. Power up; 3. Laser energy release
Figure 5: Foot switch
1.4.3 Navilas® Laser System Software Overview

The Navilas® user interface utilizes a workflow design by grouping task-relevant
information specific to the selected treatment mode. The software is controlled via the
touch-screen or via a wireless keyboard. The controls change color, depending on their
status.
1. Image area; 2. Compare Mode; 3. Optical element mounted; 4. Patient Management button (switch to
patient screen); 5. Patient info bar; 6. Workflow step; 7. Image area; 8. Treatment Mode; 9. Image gallery
Figure 6: Navilas® Software overview
The control screen is divided into the following areas:.

‣ The patient information bar shows the name, ID and date of birth of the patient.
Next to the patient info bar the current time is displayed.
‣ The current workflow step (Patient, Image, Plan, Treat and Report) is indicated in
the upper right in green.
‣ The settings panel on the right of the screen provides default controls relevant to
the currently selected operation mode.
‣ The image area displays the retina image. During Image and Treat, the image area
displays a live retina image. In other workflow steps, the image area may display
acquired images for further actions.
‣ The image gallery presents all currently available patient images. Images can be
selected for further review or analysis.
These screens are specific to the following work modes:
‣ Patient – The patient management section contains all activities related to patient
data and image management including general administration tasks.
‣ Image – The imaging workflow step allows the operator to acquire and save
diagnostic images. Controls include selection of imaging mode, adaption of light
intensity and live image viewing.
‣ Plan – Enables the operator to use a previously acquired image to plan the treatment.
The operator can define Exclusion Boundariess and Treatment Locations. A treatment
plan can be created by comparing different images of the patient.
‣ Treat – The laser can only be activated in treatment mode. Laser parameters and
all related treatment settings are located on the Treat screen, including imaging
options and laser parameters.
‣ Report – Prints out current patient images and information.
Chapter
2
Safety & Regulatory Information
Topics
‣ Classifications
‣ Regulatory Compliance and
Standards
‣ Installation & Repair
‣ Laser Safety Considerations
‣ Laser Safety Eyewear
‣ Electrical Hazards
‣ Location of Regulatory and
other Labels
20 Safety & Regulatory Information
2.1 Classifications
Table 1: Classification information
Device Classification
Directive 93/42 EEC, Annex IX Medical Device Class IIb

Classification
US FDA Medical Device Classification Class II
US FDA Product Codes HLI, MYC, HQF
IEC 60601-1 Electrical Protection Class I, Type B
Canadian Medical Device Classification Class 3
Mexican Medical Device Classification Class II
Treatment Laser
US FDA CDRH laser classification Class IV

1
European EN 60825 laser classification Class 4
Type Diode-pumped solid state, frequency-doubled Nd:YVO

or
Optically pumped semiconductor, frequency doubled
Power Output 50mW to 2W
Principal Wavelength 532nm or 577nm nominal
Aiming Beam
US FDA CDRH laser classification Class II
European EN 60825 laser classification Class 2
Type Diode, modulated
Power Output < 1 mW average output
Principal Wavelength 635 nm nominal
1
Although the classification tests are in many ways rather restrictive and worst case, there are still limitations which,
in rare cases, may lead to hazards beyond the hazards that are associated with the respective classes. Classification
is based on three “components”:
‣ The AEL (Accessible Exposure Limit) of the different classes;
‣ The measurement requirements in terms of measurement distance, aperture diameter and angle of acceptance
to reflect potential exposure conditions. These measurement requirements, for a given laser product, determine
the accessible emission that is compared to the AEL to determine the class;
‣ The test conditions under which the AEL and the accessible emission is determined. This would include taking
account of reasonably foreseeable single fault conditions. Also operational, maintenance and service need to
be distinguished. The use of accessories and different configurations of the product that can be achieved without
using tools needs to be considered.
Each of these three components has some implicit assumptions, so that in rare cases, where these assumptions
are not met, hazards beyond the usual understanding of the class can arise.
Safety & Regulatory Information 21
2.2 Regulatory Compliance and Standards

This chapter highlights safety issues that must be followed when using the Navilas®
Laser System to ensure the safety of the patient and operator and to prevent damage
to the system.
The Navilas® Laser System complies with the following regulatory and technical standards
including 21 CFR Chapter I, Subchapter J, as administered by the Center for Devices
and Radiological Health of the US Food and Drug Administration (FDA) and with all
appropriate performance standards as specified in Annex II of the European Medical
Device Directive MDD 93/42/EEC.
Table 2: Compliance information
Regulatory and Technical

Standards Compliance
EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic

safety and essential performance
DIN IEC 60601-1-1 Medical electrical equipment - Part 1-1: General requirements for safety;
Collateral standard: Safety requirements for medical electrical systems
EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
DIN IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard - Usability
EN 60601-2-22 Medical Electrical Equipment - Part 2-22: Particular requirements for

the safety and essential performance of surgical, therapeutic and
diagnostic laser equipment
21 CFR Part 1040.10 and 1040.11. Performance Standards for Light-emitting Products Sec. 1040.10 Laser
products Sec. 1040.11 Specific purpose laser products.
DIN EN ISO 14971 Medical devices - Application of risk management to medical devices
DIN EN ISO 15004-2 Ophthalmic instruments - Fundamental requirements and test methods -
Part 2: Light hazard protection
EN 60529 Degrees of protection provided by enclosures (IP code)
DIN EN 60825-1 Safety of laser products - Part 1: Equipment classification and

requirements
DIN EN 62304 Medical device software - Software life-cycle processes
DIN EN 62366:2008-09 Medical device - Application of usabililty engineering to medical devices
2.3 Installation & Repair

Installation, calibration, and all repairs or alterations must be performed by
OD-OS–certified service technicians.
A connection for a Potential Equalization Conductor is provided on the control box panel
on the Navilas Laser System. If such a connection is available in the clinical site, the
manufacturer recommends to connect the Navilas with the Potential Equalization

Conductor.
Ethernet connection
An Ethernet connection is used to allow for import of external images end export of
internal data. Imported images are only used supplementary during the planning
process. In treatment state the Ethernet connection is disabled in order to eliminate
potential unexpected influence to system behavior from the environment. So failure
of the environment or the Ethernet connection to provide appropriate data cannot lead
to a hazardous situation.
Characteristics of the Ethernet connection are:
‣ 10/100/1000 based Ethernet
‣ RJ 45 connector
‣ Communication to connected network via TPC / IP file sharing and printer port
‣ DHCP required externally or Navilas® Laser System configured to fixed address
Warning: Rooms containing hazardous materials are not suitable as laser rooms, as they present a
fire hazard during laser operation.
Note: Although care must be taken to avoid water in the vicinity of the laser, small amounts of water
or fluid spills near the laser will generally not affect the Navilas® Laser System.
Note: The connection for fiber detection is provided within the Navilas® Laser System and needs to
stay plugged in all the time.
2.4 Laser Safety Considerations

The Navilas® Laser System is safe for the operator, the patient, and for treatment room
personnel as long as the operation is in accordance with the instructions provided in
this operator manual. The maximum laser radiation is not exceeded even in the case
of system malfunction. Refer to Laser Specifications on page 83 for additional
information.
Warning: OD-OS lasers are intended solely for operators trained and authorized in the use of the
Navilas®.
Warning: Federal law restricts this device to sale by or on the order of a physician.
Warning: Any use of the Navilas® or parts thereof for procedures other than those specified herein
may result in hazardous exposure to radiation and hazardous electrical exposure.
Warning: Lasers generate a highly concentrated beam of light that may cause serious injury if
improperly used. To protect the patient and the operating personnel, this entire laser operator manual
or accessory manuals, including all Safety and Regulatory sections, must be carefully read and
comprehended before operating the Navilas® Laser System. All persons in range of possible laser
radiation must be informed about and have a thorough understanding of all safety hazards, especially
the specific ocular risks and hazards. Everyone within the controlled area is at risk of accidental laser
exposure and laser reflection.
Warning: Severe and irreversible eye damage and scarring may occur from direct or indirect exposure
to the treatment beam. Severity of injury is dependent on how concentrated or diffused the treatment
beam is and on the length of exposure. A thorough understanding of the specific ocular risks and
safety precautions is necessary to ensure the safety of the patient and operating personnel.
Warning: Never look directly into the laser optical lens, except for therapeutic purposes. Severe eye
damage could occur. Turn off the laser before inspecting any laser components.
Warning: Do not use the laser in the presence of flammable gases or explosives, such as volatile
anesthetics, alcohol, certain surgical preparation solutions, and similar substances. An explosion and/or
fire could occur.
Warning: To prevent accidental laser exposure, only the physician directing the aim of the laser
beam should have access to the laser footswitch.
Warning: During preoperative safety checks and during functional maintenance of the laser, all
persons within the laser room must wear appropriate laser safety eyewear. Refer to the Laser Safety
Eyewear section of this operator manual, for additional important information concerning eye protection.
Warning: To prevent serious injury, never direct the laser beam at any person or object, other than
at the intended Treatment Location. Ensure that laser pulses are only delivered in the course of treating
a patient.
Warning: The cable harness leading to the device head contains an optical fiber. Therefore it must
be treated with utmost caution. Bending the optical fiber might result in damage to the fiber. Also
unwanted laser radiation might be released which could harm operator or patient.
Warning: The Navilas® Laser System is not intended to be moved from one room to another.
2.5 Laser Safety Eyewear
Warning: Laser safety eyewear is routinely required with most lasers. When using the Navilas® Laser
System, the Laser Safety Officer should determine the need for safety eyewear based on the Maximum
Permissible Exposure (MPE), Nominal Hazard Zone (NHZ), the Nominal Ocular Hazard Distance (NOHD),
and the optical density (OD) for the laser emissions and the configuration of the treatment room
(usually within the controlled area). This includes protection for the treating physician. For additional
information, refer to ANSI Z136.1-2000, ANSI Z136.3-1996, or European Standard EN 60825: 1992,
Appendix A.
All personnel who are within the NOHD are considered to be within the controlled area
and shall wear eye protection with a minimum optical density (OD) of OD5
Laser safety eyewear must also be resistant to physical damage or photo bleaching
resulting from laser exposure as per ANSI Z136.1-2000, section 4.6.2 and Appendix
C. For users who must comply with EN 207, the safety eyewear must have a protection
class of:
Protection adequate to block the 532nm wavelength
‣ Optical density: OD6
‣ D > 315-532 nm L5
Protection adequate to block the 577nm wavelength
‣ Optical density: OD5+
‣ D > 575-579 nm LB5
Warning: In case of damage to the laser safety eyewear, or a discoloration or change of color,
discontinue use and replace the eyewear with a new pair.
Warning: Never substitute prescription eyewear for the appropriate laser safety eyewear, as severe
eye damage could occur. Prescription eyewear can concentrate the laser light to the eye and/or can
be shattered by a high power density beam, possibly causing severe eye damage.
In addition to providing the required laser safety eyewear, take the following steps to
secure the treatment room, or the controlled area:
‣ Alert personnel before they enter the controlled area, by placing a “laser in use”
warning sign on the outside of the treatment room door when the laser is in use.
‣ Close the treatment room door during operation of the laser.
‣ Use external door interlocks that automatically disable the laser when the treatment
room door is opened may be installed.
2.6 Electrical Hazards

The following electrical precautions have to be taken when using the Navilas® Laser
System.
Warning: Do not open or remove the laser console protective covers. Doing so will expose personnel
to possible laser radiation. Only an OD-OS–certified service technician is allowed to open or attempt
to repair the Navilas® Laser System.
Caution: Routine inspection and regular maintenance must be performed according to OD-OS
manufacturer’s recommendations and institutional standards.
Warning: Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
The Navilas® Laser System is an electrical protection Class I, Type B device. Medical
electrical devices require special attention regarding electromagnetic compatibility
(EMC). Portable and mobile HF communication devices can affect medical electrical
devices.
2.7 Location of Regulatory and other Labels
1. Laser aperture; 2. Laser aperture label
Figure 7: Position of Laser Aperture and Laser Aperture Label
1. System labels
Figure 8: Position of Labels
Table 3: Safety labels on page 26 explains the meaning of each label affixed to the
Navilas® Laser System.
Table 3: Safety labels
Label Description
Type Label: Navilas® Laser System 532+

Containing the following information: Electrical Specification
LabelIngress Protection LabelManufacturer’s Serial, Part number, Date
of Manufacture Label
This label is affixed to the control box panel.
Type Label: Navilas® Laser System 577+

Type Label: Navilas® Laser System 532

CE Mark. Confirms compliance with the Medical Device Directive MDD

93/42/EEC. Contained on type label.
Operator Manual Label—Read and comprehend the operator manual

before use. Contained on type label.
Type B Electric Shock Protection Label—identifies the system as having

Application Part Type B electric shock protection classification, contained
on type label
This product is labeled with this symbol in accordance with European

Directive 2002/96/EG to indicate that it must not be disposed with
household waste.
Laser Stop Label—Affixed on or near the emergency stop button.
Laser Aperture Label—The laser aperture label is affixed next to the

laser aperture.
Laser Warning Label (Navilas® Laser System 532+)

Danger Label, Class 4/IV laser product—the laser danger label is affixed
to the control box panel.
Label Description
Laser Warning Label (Navilas® Laser System 577+)

Danger Label, Class 4/IV laser product—The laser danger label is affixed
Laser Warning Label (Navilas® Laser System)

Danger Label, Class 4/IV laser product—The laser danger label is affixed
ISO 7010-M002
The operator manual must be carefully read and comprehended before
using the Navilas® Laser System.
Door Interlock
Foot switch connector
Equipotentiality
Network
IPX5 Watertight/Waterproof Footswitch Label—This label is affixed to the

laser system footswitch and denotes that the foot switch is watertight
/ waterproof.
Label Description
Fuse Rating Label - This label is affixed to the control box panel
US Sales Restriction Label - This label is affixed to the control box

panel. (For systems shipped to the US)
DHHS Certification Label (1010.2) - This label is affixed to the control

box panel. (For systems shipped to the US)
Patents Label - This label is affixed to the control box panel
Flammable anesthetics
Chapter
3
Installation
Topics An OD-OS–certified service technician will initially uncrate,
inspect, install, calibrate, and set up the Navilas® Laser
‣ Connecting Accessories System at the facility to ensure that it is working properly.
‣ Start Navilas & Log On
Warning: Initial installation, set up, calibration and any system
‣ Log Off & Shut Down configuration changes must be performed by an OD-OS–certified
‣ Move the Navilas Laser service technician.
System
‣ Emergency Laser Shutoff In addition, OD-OS provides training to ensure that the
treatment room personnel are familiar with the performance
and safety considerations of the laser. Thereafter, the
physician, or the treatment room personnel, will perform the
daily maintenance routines associated with the Navilas® Laser
System, including inspecting and cleaning the laser;
connecting and disconnecting accessories; and the daily
pre-operative verification of the aiming beam. These
procedures are detailed in this operator manual and in
manuals provided with accessories.
The Navilas® Laser System is delivered with the latest software
pre-installed. No software installation by the client is
permitted. OD-OS–certified service technicians assist in
affixing any required laser room warning or labels.
30 Installation
3.1 Connecting Accessories

Open the front panel of the electronics housing and attach the accessories as follows
(see Figure 10: Accessory connection ports on page 31):
1. Connect the Access Key to the top USB port.
2. Connect the keyboard to the second USB port from the top. (If the mouse or keyboard
does not respond, be sure the mouse is turned on.)
3. Connect the door interlock plug into the Door interlock port (see Figure 10: Accessory
connection ports on page 31) or attach the laser Door interlock / warning sign
according to the figure below.
4. Connect the foot switch to the second port from the top on the right. (The red dot
indicates the top of the plug.)
5. Connect the printer power
a. Connect the router with a network cable to the Navilas®.
b. Connect the printer with the router via a network cable.
c. Connect the router and the printer with power supply.
1. Door interlock plug socket; 2. Door interlock plug; 3. Safety switch; 4. External door
Figure 9: Door Interlock Connection
Check that the main power supply of the printer is set to “ON” and then start the
Navilas® Laser System as described in the next section.
Caution: Do not connect or disconnect the printer from the Navilas® Laser System when live or under
load!
Warning: Due to the impact of the leakage current, it is not allowed to connect or disconnect a
multiple socket-outlet nor an extension cord to the Navilas® Laser System. Do not connect any
equipment that is not part of the Navilas® via a multiple socket-outlet.
Installation 31
1. Access Key; 2. Mouse and Keyboard; 3. USB Ports; 4. Network; 5. Door interlock; 6. Foot switch; 7.
System power supply
Figure 10: Accessory connection ports
3.2 Start Navilas® & Log On

Insert the key into the key switch, turn it clockwise and release it. In the “off” position
the indicating lights above the key will be off. The key is spring-loaded and will return
to a vertical position when it is released. Once the initialization and start up is complete,
the Treat screen will be shown immediately to start the treatment. If the user has
logged off, a list of users appears on the screen. Select the appropriate account name
from the list. An authorization screen appears, prompting the operator to enter a PIN.
If the wrong name was selected inadvertently, return to the user selection screen by
clicking the left-pointing arrow button in the lower left corner.
1. Numeric keypad; 2. Delete all entered numbers; 3. Return to user selection; 4. Delete last digit; 5. Confirm
PIN
Figure 11: Authorization screen
32 Installation
The Navilas® Laser System ships with several pre-defined roles for normal use, which
provide access to applications and features based on job responsibility:
‣ Physician (operator for treatment and imaging)
‣ Nurse (operator for imaging only)
‣ Administrator (operator for backup and other administrative features)
‣ Service (allows OD-OS–certified service technicians to perform various system
diagnostics and maintenance tasks)
A special Training mode is also available, which deactivates the laser but allows for
all other features. This mode can be used to demonstrate how the Navilas® Laser System
is used with no risk of injury.
Training mode is enabled by removing the door interlock located directly above the
connector for the foot switch. If the door interlock is not removed, this mode will not
be enabled and an error message appears.
Please note that only operators with the appropriate certification issued by OD-OS are
allowed to use the Navilas® Laser System. The training of new operators is to be
performed by OD-OS or by OD-OS certified trainers (distributors). Please call the
Navilas® help desk if training is needed.
If the door interlock (see Figure 10: Accessory connection ports on page 31) is removed
during normal operation, the laser is deactivated immediately, and an error message
appears indicating that the door interlock has been removed. Reattach the door interlock
to disable training mode, reactivate the laser and return to normal operation mode.
When demonstrating the Navilas® Laser System’s capabilities, first be certain that the
training mode is active (indicated by a green background in the user interface).
3.3 Log Off & Shut Down

To stop image acquisition or treatment and end the current session, press the workflow
button in the upper right of the screen and press Log out. The Log In screen appears.
To exit the Navilas® software application and shutting down the Navilas® Laser System,
press the Shut Down button in the Log In screen. Afterwards the indicating light next
to the key switch will be off.
Caution: Always shut off the software application before switching off the Navilas® Laser System via
the main power switch.
Caution: Never completely shut down the Navilas® Laser System if the camera and the scanner are
actively acquiring an image. Doing so may damage the system.
Note: The key should not be left in the lock when the Navilas® Laser System is not in use in order to
prevent unauthorized usage.
Installation 33
3.4 Move the Navilas® Laser System

To move Navilas®:
‣ Shut down the Navilas® Laser System. Remove the main power plug from the
electrical outlet.
‣ Unlock the table wheels by pulling up the lock button.
‣ Move Navilas® to the required new position and re-connect the main power plug to
an electrical outlet and lock the table wheels again.
1. Wheel lock
Figure 12: Locking the table wheels
Warning: As with any heavy equipment, use caution when tilting the Navilas® Laser System or moving
it up or down an incline. Ask a second person for help if necessary.
Caution: Do not move the Navilas® Laser System rapidly over uneven surfaces; doing so may damage
the system.
3.5 Emergency Laser Shutoff

In emergency or hazardous situations, press the red emergency laser shutoff button
to immediately de-energize the laser. Thereafter the Navilas Laser System needs a
reboot and should be started again.
34 Installation
Figure 13: Emergency laser shutoff button
Chapter
4
The Navilas® Workflow
Topics The menu at the top of the Navilas® Laser System user
interface helps to guide the operator through the process of
‣ Create or Select a Patient selecting a patient, creating an image of the eye, planning
Record the treatment process, treating the patient and reporting and
‣ Positioning Patient and documenting the results of the procedure.
System
‣ Image and Image Review
‣ Plan the Treatment
‣ Treat
‣ Report
36 The Navilas® Workflow
4.1 Create or Select a Patient Record

In order to begin working with Navilas® Laser System, first select an existing patient
record or create a new patient.
Warning: Protect patient data by ensuring that only authorized personnel has access. Prevent
unauthorized use by always logging off after using the Navilas® Laser System, never leaving the key
in the system unattended, and by always safely securing the key when the system is not in use.
Unauthorized use can destroy, invalidate, or corrupt patient data leading to incorrect diagnostic results,
Treatment Plans, and therapeutic decisions.
When the Navilas® Laser System is started, the Treat screen appears and the Navilas®
has already generated a new anonymous patient with a certain Navilas® ID. The Patient
bar in the bottom can be used to create new patient records and to select an existing
patient before and after treatment. If no patient details will be entered by the operator
all patient data and treatment information will be stored under a certain Navilas® ID
in the patient database. Furthermore by clicking the Patient Management button the
software will switch to the patient screen. This screen can also be used for further
patient management, such as edit or manage existing patient records.
1. Patient list; 2. Search field; 3. Date filter; 4. New patient; 5. Switch between patient and treat screen
(Patient Management button); 6. Patient bar; 7. Modify patient details; 8. Move images; 9. Image review
area; 10. Create new anonymous patient
Figure 14: The Patient management screen
4.1.1 Select an Existing Patient Record

An existing patient can be selected either via the Patient Bar from each workflow step
or via the Patient Data Base from the patient management screen.
To select an existing patient record via the Patient Bar:
1. Click with the mouse cursor into the Patient Bar.
The Navilas® Workflow 37
2. Enter at least the first three letters of the patient’s name into the Patient Bar.
3. The search input will filter the list of available patient names to show only the names
that match the entry.
4. Use the scroll bar to navigate to the patient name, or enter the full name of the
patient to retrieve the specific patient record.
5. Click on the patient name to select it.
To select an existing patient record via the Patient Data Base from the patient
management screen:
1. Touch or click into the search field.
2. Enter the first few letters of the patient’s name into the search field.
3. The search input will filter the list of available patient names to show only the names
that match the entry. Use the patient list scroll bar to navigate to the patient name,
or enter the full name of the patient to retrieve the specific patient record.
4. Click on the patient name to select it.
5. As shown in Figure 14: The Patient management screen on page 36, the patient
information will appear in the patient data area and the patient’s images appear in
the image review area. The name of the patient appears in the patient bar at the
bottom of the screen.
6. Click the patient's name to display the patient history screen (optional).
7. The patient history shows the dates and activities of prior sessions. Close the patient
history screen either by selecting another patient or by clicking the active patient
name.
4.1.2 Create a New Patient Record
Note: Before creating a new patient record, always verify that the patient is not contained in the
database. Use the advanced Database Search screen located in the patient management submenu.
Note: Patient data entries are the responsibility of the operator and optional. OD-OS always
recommends to enter always patient details. If no details of the patient will be entered, the Navilas®
will create a new anonymous patient with the ID Navilas00001 etc.
1. Cancel creation and changes; 2. Confirm entries and create patient
Figure 15: Create a new patient record
A patient can be created either via the Patient Bar from each workflow step before
or after treatment or via the Patient Data Base from the patient management screen.
Create a new patient record via the Patient Bar:
1. Click with the mouse cursor into the Patient Bar.
2. Enter the patient’s name and/or ID into the Patient Bar.
3. Enter the birth date into the Patient Bar.
To select an existing patient record via the Patient Data Base from the patient
management screen:
1. On the Patient management screen shown in Figure 14: The Patient management
screen on page 36, click the New Patient button. A window appears in which the
information on the new patient can be entered.
2. Enter the patient’s last name, first name and birth date.
3. Click the Create button to create the new patient record.
4. The New Patient window closes and the newly added patient is selected in the Patient
management screen. To cancel creation of the new patient record, click the Cancel
button. The entry will be discarded.
4.2 Positioning Patient and System

The sections below describe the common setup procedures required to adjust the
position of the patient and the Navilas® Laser System to ensure the best image quality,
patient comfort and facilitate treatment.
4.2.1 Exchange optical elements

The Navilas® Laser System is equipped with an interchangeable optical elements
assembly that is connected to the system with a locking ring on the device head.
The standard optical element provides a 50° field of view when used with a standard
zero power contact lens. With this configuration, both conventional and navigated
treatment and all imaging modes are supported.
A peripheral optical element provides an ultra-wide-field image when used with a
corresponding peripheral contact lens.
For treatments of anterior segments of the eye with applicable contact lenses, an
anterior optical element needs to be connected (see also Positioning with the Anterior
Optical Element on page 42)
To exchange the optical elements, twist the locking ring on the device head
counter-clockwise until the dot on the ring is in the 12 o’clock position and registers
with the dot on the optical element. When the dots are aligned, pull the optical element
away from the device head to remove it.
To attach the optical element, place the base firmly into the socket on the device head,
taking care to align the dot on the optical element with the dot on the locking ring on
the device head. Twist the ring clockwise (approximately 90°, to the 3 o’clock position)
to lock the optical element.
Figure 16: Interchangeable optical element (left: locked, right: unlocked)
4.2.2 Positioning the Patient
Caution: Prior to every patient session, thoroughly clean the headrest, patient armrest, and holder.
Warning: Ensure that the patient is well informed regarding the proposed procedure and verify that
he/she is properly positioned. An uncooperative patient or improper patient positioning may cause
poor image quality.
1. Position the patient in front of the Navilas® and place his/her head into the headrest,
with the chin and forehead pressed firmly but comfortably against the headrest.
2. Adjust the table height using the up/down button on the table until the patient is
sitting comfortably and straight.
3. Adjust the chin rest height so that the patient's eye is aligned with the mark on the
vertical rail that holds the chin rest. Move the device head and the base backwards
towards the operator. If the patient is properly aligned, a light reflection from the
pupil will be visible in the middle of the imaging screen.
1. Eye height marker; 2. Height adjustment
Figure 17: Proper patient positioning
Caution: Ensure correct placement of patient’s hands to avoid interference with the motion of the
device head.
Caution: Incorrect positioning of the patient or the device head may produce poor quality images.
Incorrect positioning may also produce vignetting effects when moving the Navilas® Laser System
during normal usage, such as when tilting or moving the device head laterally.
Before proceeding with a therapy or a fluorescein angiography (FA) session, first apply
either one of the OD-OS–licensed contact lenses, or the injection preparation, depending
on the procedure, before positioning Navilas® as for previous methods for laser therapy.
4.2.3 Positioning with the Standard Optical Element

1. Align the device head so that it is in mid-position for both the tilt and the swing
function.
2. To move the device head to the right or left eye, push or pull the base with the
joystick. For rough adjustment, push the whole device head; for finer adjustment,
move only the joystick.
3. Adjust the device head height by rotating the joystick base (rotate clockwise to
move up, counter-clockwise to move down).
Figure 18: With the device head moved backward, Figure 19: Pushing the device head forward, with the
the full eye is visible and the reflection of the pupil bright reflection of the pupil / retina centered in the
is centered image. The reflection of the retina becomes larger
and more visible.
Figure 20: Intermediate step before being correctly Figure 21: Device head is correctly adjusted. No
adjusted. Vignetting on the image border and reflections or vignetting are visible.
reflections indicating that the operator either needs
to push forward more or pull a bit backwards.
First position the device head so that the bright reflection of the pupil is in the center
of the image as shown in Figure 18: With the device head moved backward, the full
eye is visible and the reflection of the pupil is centered on page 40. Then push the
device head forward until the whole image is highlighted and there is no vignetting. If
there is evidence of reflections, blurred borders, or reduced brightness or saturation
at the periphery, the device head is not properly positioned.
Once the device head is properly positioned, verify that the patient’s refraction is
corrected. Refraction errors can cause blurred images. Therefore, correct the patient’s
refraction following the instructions below.
This focusing process can be used in any imaging mode. It works for FA, IR, and color
imaging. In cases where a patient has astigmatism of more than 2 diopters, it is
recommended that the patient wear contact lenses with appropriate correction, if
available.
1. Move the scroll wheel on the joystick to adjust focus.
2. Two focus indicators appear in the image.
3. Roll the wheel up or down to align the indicators in a vertical line.
4. The focus indicators will be switched off automatically after a short period of time.
Figure 22: Focus indicators out of alignment Figure 23: Focus indicators properly aligned
Note: Due to the optics of the eye, the focus adjustment may vary in different eye segments. This
is not a failure of the Navilas®. In the periphery, the image may suffer from more imaging artifacts
than elsewhere. Repeat the focus adjustment procedure to correct the sphere in different areas of the
eye.
At this point, adjust the light intensity by pressing the Illumination control on the device
head until the infrared image is visibly illuminated (default light level 5).
4.2.4 Positioning with the Peripheral Optical Element

Exchange the optical elements for use with a peripheral contact lens connected to the
eye and proceed as following in order to position the system:
1. Prior to positioning the system ensure that the tilt and also the swing movement is
in the center position.
2. Pull the system back in order to apply the contact lens.
3. For easiest positioning try to keep the contact lens as straight as possible and push
the system forward until an image becomes visible (about 2 cm between system
surface and contact lens).
4. If you start seeing the scratches on the contact lens without having seen the image,
increase the distance between contact lens and system by a few millimeters and
slightly tilt the contact lens.
5. Positioning of the system using the peripheral optical element is easiest in color
imaging mode.
4.2.5 Positioning with the Anterior Optical Element

For treatments of anterior segments of the eye, an anterior optical element needs to
be connected for use with a three mirror or a four mirror contact lens. Connect the
anterior optical element to the Navilas® Laser System the same way as the peripheral
optical element. The principle of use is the same as in Navilas® Peripheral Mode
(described under Conventional Patterns on page 56).
4.3 Image and Image Review

Once a patient record is created or selected as described in the previous section, proceed
to the imaging phase.
For color imaging with non-dilated pupils, no special patient preparation is required.
With the Navilas® Laser System, the imaging process is possible without pupil dilation.
However pupil dilation is recommended, as it significantly improves the image quality.
For pupil dilation, follow the instructions of the medication manufacturer.
4.3.1 Select the Imaging Mode

Once the patient and device head are properly prepared and positioned as described
in the previous sections, use the options in the settings panel of the Image screen to
select the imaging mode (see Figure 24: Image screen on page 43).
When the Navilas® Laser System is started, the Treat screen appears. An image can
rapidly be taken by pressing the Trackball on the Treat screen, the Navilas® software
will switch to the Plan screen in order to start planning. The Fluorescein Angiography
can only be performed via the Image screen. All other imaging modes can be done
via both ways.
1. Previous taken image; 2. Mydriatic color, 3. Non mydriatic color (Imaging mode activated); 4. Infrared;
5. Fluorescein Angiography
Figure 24: Image screen
4.3.1.1 Non–mydriatic and Mydriatic Fundus Photography

Two color imaging modes are available:
‣ “mydriatic color” – a continuous color image can be visualized on the display
‣ “non mydriatic color” – adjustment of the device head in comfortable infrared light
and a short color snapshot
Select the mode by using either the software controls or the buttons on the device
head.
The current mode is indicated in blue on the screen. Verify that the desired mode is
selected and proceed as described under Select the Area for Imaging on page 44.
Note: Generate dimmed light conditions in case of non mydriatic image acquisition.
4.3.1.2 Fluorescein Angiography

In the Fluorescein Angiography (FA) mode, the Navilas® Laser System has the ability
for a snapshot to be taken using a blue light that can be reduced to a low light level
(or down to zero) during the positioning process to minimize patient discomfort. During
the image snapshot, the blue light is briefly increased to 100% to acquire high quality
images. In patients that tolerate higher light levels the mode can also be changed to
a standard FA mode with continuously 100% light which leads to a constantly high
quality. The zero level used in this mode can be adjusted via the illumination slider.
The intensity of the snapshot can be adjusted in the submenu.
Warning: A patient’s eye must not be exposed to blue (FA) or visible (color) light for more than one
hour to avoid photo toxicity.
Caution: If the Navilas® Laser System is used for more than one hour at the same patient the
illumination is switched off in order to avoid photo toxicity.
1. Before starting the Fluorescence Acquisition prepare the patient’s injection, following
medication manufacturer’s instructions and standard clinical procedure.
Properly position the patient and device head as described under Positioning Patient
and System on page 38. To increase patient comfort, use Infrared imaging mode.
2. After the patient is properly positioned, select the FA mode either by pressing the
FA button in the settings panel of the Image screen or by pressing the FA mode
button on the device head.
If desired, adjust the zero level of the FA Mode. The default setting for the software
is 30% of the total available light amount.
A small infrared image thumbnail appears in the lower left of the image display. This
image shows the actual visible image in infrared, which allows the operator observe
the patient’s eye movement as long as the fluorescein has not reached the eye.
3. Start the FA timer by pressing the Start Timer button in the settings panel of the
Image screen and inject the dye into the patient's vein. Acquire an image directly
after the injection using the acquire buttons. If the timer is started by accident, use
the reset button to set it to zero again. Restart the timer when the injection is
administered.
Note: Fluorescein Angiography is only available when using the standard optical element.
4.3.2 Select the Area for Imaging

When the patient and device head are suitably positioned and the desired imaging
mode has been selected as described in the previous sections, the next step is to
fine-tune the positioning to ensure that the image contains the area of interest. The
method of selecting the image area depends on the selected optical element.
When the Navilas® Standard Optical Element is used:
1. Use the tilt and swing movement capabilities of the device head to target an area
of the eye for imaging.
2. While turning the device head with one hand, stabilize the device base with the
other. When turning the device head, take care not to inadvertently move the base
and subsequently lose the desired optical path. Doing so will inhibit image quality.
3. Press the Scroll wheel on the joystick to adjust the focus. The focus diodes needs
to be aligned. This can be reached by scrolling the wheel. Press again the Scroll
wheel will make it disappear.
4. Additionally, the external fixation target can be adjusted to help the patient direct
their gaze in the proper direction, thus further optimize the selected image area.
5. After selecting the appropriate field of acquire an image by, either pressing the
Trackball on the joystick or press one of the acquisition buttons on the device head.
When the Peripheral Optical Element is used:
1. The currently visible Field of View is not changed by the tilt and swing (Difference
to the standard optical element, where a tilt and swing results into a change of the
currently visible field of view). Both, tilt and swing, should remain in the zero position
during the whole procedure while using the peripheral optical element.
2. Use the joystick to rotate the optical head up and down in order to visualize the
inferior or superior section of the retina.
3. Move the joystick right or left to make temporal or nasal areas visible.
4. Always correct the focusing by back and forth movements.

5. Additionally, the external fixation target can be adjusted to help the patient direct
their gaze in the proper direction, thus further optimize the selected image area.
6. After selecting the appropriate field of acquire an image by, either pressing the
Trackball on the joystick or press one of the acquisition buttons on the device head.
4.3.3 Image Review

Once a series of images has been captured, use the image gallery to review the available
images, select those that are most suitable for planning and treatment and discard any
undesired images.
Figure 25: Image review on Plan on page 45 shows the options available for image
review.
1. Accept change; 2. Move back in image cache; 3. Move forward in image cache
Figure 25: Image review on Plan
1. To review acquired images, open the image gallery.

2. The Navilas® Laser System evaluates each image and indicates whether it is suitable
for use as an overlay. Images that are suitable for use are marked with a green
checkmark. Unsuitable images are marked with a red cross.
3. To review a specific image, touch the image or drag it into the main image viewing
area to start review. Additional image enhancement elements will become visible in
the upper left corner of the image.
4. If there is evidence of movement artifacts or eyelid closure in the image, try selecting
an earlier image.
5. Press the left button (move backward in the image cache) to view earlier images.
Press the right button (move forward in the image cache) to view later images. To
flag images for saving, press the check mark button. To review a different image,
touch another image or drag it from the gallery into the main image viewing area.
6. Return to the live image at any time by selecting the return-to-live-image button
(X).
7. All images are saved automatically. To remove unusable images from the database,
long click to select images and press Delete. Selected images are indicated by a
green bar to the left of the image.
4.4 Plan the Treatment

Once a patient is selected and the necessary images are acquired, proceed to the
planning phase.
Note: The planning phase only applies to Navigated Treatment Mode. For conventional treatment,
proceed to the next workflow step described under Treat on page 51.
The usage of the treatment and treatment planning capabilities is restricted to

ophthalmologists.
Creating a treatment plan improves treatment transparency and enables the operator
to activate navigated functions. The plan helps the operator to visualize the targeted
treatment areas and areas where laser activation should not occur.
Figure 26: Plan screen on page 46 shows the available options on the Plan screen.
1. Applied Exclusion Boundaries; 2. Compare Mode; 3. Applied Treatment Location (Feeder Vessel); 4.
Settings; 5. Applied Treatment Location (Freeform pattern); 6. Import button; 7. Single spot (activated
treatment location); 8. Available treatment pattern; ; 9. Eraser; 10. Switch to split screen
Figure 26: Plan screen
4.4.1 Select an Image for Planning

To create a treatment plan, select a previously acquired image to base the treatment
plan on. To select the image, touch it or drag the desired image into the image viewing
area. A new treatment plan will be created when an image is selected and figures
(Treatment Locations and Exclusion Boundaries) are applied within this image.
Note: Only images taken using the standard optical element are suitable for planning. If an image
taken with the peripheral lens is selected as the basis for a Treatment Plan, an error message will
appear when the first Treatment Location is defined.
4.4.2 Work with Comparison Images

The Navilas® Laser System supports the usage of multiple images from the Navilas®
system and the import of images from external imaging systems.
Compare Navilas® images
To use further images in the treatment plan, select the desired images and press the
Split screen button which allows the comparison of four images.
1. Plan image; 2. Compare images; 3. Overlay transparency; 4. Close (open) Compare Mode; 5. Switch to
standard screen
Figure 27: Split screen (Plan comparison mode)
TheNavilas® Laser System has three available comparison modes and any of them can
be used when creating the Treatment Plan. The Compare Mode can be opened via the
button in the lower left. Up to four images can be selected from the gallery to be
compared. The first image is always the Plan image. When all images to compare are
selected they appear in green. With a click on the image, they will be greyed out, and
they are not selected for comparing.
The table below describes the options available for comparison.
Table 4: Comparison modes
Mode Description
Baseline image (single image only) Single image only. Finishes the comparison of two
images.
Overlay direct transparent overlay A comparison image (a second selected image)

is overlaid and registered on a baseline image
(the first selected image) with a transparency
value adjustable when the Compare Mode is
opened (Overlay Transparency).
Mode Description
Rapid overlay Alternate between two images Two selected images will alternate back-and-forth.
compare The baseline image and the compare image will
be compared with a defined frequency. To adjust
the Rapid Overlay Frequency set the value in
the Compare Mode Side Bar greather than 100%.
Split screen side-by-side viewing Up to four selected images will be compared side
by side (registered). The baseline image is always
on the upper left.
To compare two or more images:

1. On the Plan screen, click the Split Screen button in the settings panel on the right.
2. Open the image gallery to select the comparison images. Drag the desired comparison
image and drop it on the slot symbol. The images will be registered for comparison.
3. Planning process can be started as described in Define Exclusion Boundaries on page
49 and Specify Treatment Locations on page 50.
4. When the image comparison is finished, press the Split Screen button to go back
to standard view.
5. The baseline image and the comparison image will be disconnected. The treatment
plan will be saved automatically to the baseline image.
To change the baseline image during comparison choose a new baseline image. Once
the new baseline image is chosen, select the desired comparison mode. All treatment
plan elements used while comparing images will be saved into the baseline image. The
baseline image then contains is the treatment plan image and can be used for
visualization during treatment.
Use external images for planning
The Navilas® provides the opportunity to use any image from imaging systems, such
as OCT, Autofluorescence or other fluorescein angiographies as planning assistance.
1. Baseline image; 2. Registration quality; 3. Preview button; 4. Compare image
Figure 28: External Image Registration (Navilas® Contact)
To upload and start the registration process between a Navilas® image and an external
image proceed as following:
1. Select a Base Image from the gallery.
2. Click on the Import button to upload the external image and start the registration
process. A new window is presenting with the selected base image window from the
Navilas® System.
3. Select the image from either a USB stick or from a network drive. The external
image will be visualized in the left panel.
4. The external image can be cropped to the desired size if necessary. Select Field of
View to simplify registration.
5. Start the registration process by marking the same landmarks in both images. First
click on a retinal structure in the Navilas® image (left image) and click on the
corresponding structure in the external image (right image). After the first registration
point is defined, the cursor moves automatically to the Compare Image Section.
6. Repeat the same procedure at least for 3 landmarks which are required to create a
registration. It is recommended to place corresponding landmarks until the quality
bar is changing to green.
7. Click on the Preview button to see a preview on the registration results.
8. Click the green checkmark to start with the planning.
Caution: Prior to use an external image, check the correct calculation (e.g. of thickness maps)
directly at the external imaging system. After importing to Navilas® check the correct display of
the images.
After the registration is completed successfully start with the planning process as
described in Define Exclusion Boundaries on page 49 and Specify Treatment Locations
on page 50. While planning treatment locations a separate window (the base image
window) is presenting the originating Navilas® image. Use this base image window in
order to verify the correct location of the planning spots.
Figure 29: Base Image window while planning on external images
4.4.3 Define Exclusion Boundaries

These zones are designated areas in which the laser should not be applied during
photocoagulation. Exclusion Boundaries are zones that make it easier to mark and
identify critical, non-target tissues.
To create Exclusion Boundaries:
1. Select a zone shape by choosing an element in the settings panel.
2. To position the zone, grab the center of the figure and move it.
3. To resize the zone, grab and move the green bubble on the figure.
4. The zones can be resized and moved at any time in the process. To reposition, select
the desired zone by clicking on it and moving it to the desired location.
Treatment Locations that are planned inside Exclusion Boundaries will appear in grey
color. Laser energy will not be applied actively in these Treatment Locations. The laser
will advance to the next planned Treatment Location.
Warning: Pre-Positioning inside Exclusion Boundaries is not possible.
Warning: In case of strong eye movements latency may be subject to inaccuracies. The operator
shall observe always carefully the position of the laser during photocoagulation.
4.4.4 Specify Treatment Locations

The Plan step serves to visualize targeted pathologies and to pre-operatively plan
areas of proposed treatment by designating spots and pattern treatment areas.
The Navilas® Laser System will not automatically process laser spots during treatment,
but instead helps the operator to visualize and target Treatment Locations. When the
patient is present, and prior to laser activation, the operator must position the laser
and the aiming beam using the trackball on top of the base joystick or the
Pre-Positioning function.
Different Treatment Locations are available such as single spot, feeder vessel line,
freefrom pattern (hexagon and rectangular), arc pattern and circular pattern. The
freeform patterns are particulary suitable to mark rapidly whole areas. To move a
pattern to another position or to position a single spot very correct, click long on the
pattern or single spot. Arrows will be visible in each direction. Now move the Treatment
Location to the desired location.
To plan where to apply laser treatment, use the treatment pattern selectors, as described
below:
1. If an image has not yet been selected as the basis for the treatment plan, open the
image gallery and drag and drop the desired image into the image review area.
2. Choose a Treatment Location pattern by pressing one of the available pattern buttons.
3. To position the treatment pattern on the image, click the location on the image
where elements shall be placed. The pattern appears at the specified position.
4. Resize the Treatment Location pattern by adjusting the parameters.Parameters will
be changed for the currently selected point.
5. Patterns can be repositioned, replaced, erased or deleted. To select a specific point,
click directly onto the spot. A rectangular box appears to represent the selection.
When the eraser in the Plan tool bar is activated, the eraser will appear in blue color
and can be used to take off spots on certain veins. The size of the eraser correspond
to the adjusted spot size of the selected pattern or single spot.
4.4.5 Adjust Pattern Parameters

If the spot size or spot spacing parameters are increased, the overall pattern area is
correspondingly increased. To prevent inadvertent tissue damage or unintended injury
of critical structures, after adjusting spot size or spacing parameters, always re-verify
the planned treatment area prior to laser treatment.
Figure 30: Adjusting pattern parameters for freeform pattern, circular pattern and arc pattern
Table 5: Pattern parameters on page 51 describes the available parameters.
Table 5: Pattern parameters
Parameter Pattern type Description
Pulse duration All patterns Pulse duration that shall be adjusted during treatment
Spot size All patterns Diameter of all spots within this pattern
Spacing All patterns Distance between the spots (times of spot size)
Number of spots Freeform pattern Number of lines in rectangular pattern
Inner diameter Circle and arc Diameter from center to the most inner line of spots
(µm)
Rotation Arc Clock rotation of an arc segment
Angle Arc Opening angle of the pattern.
Pulse duration All patterns Specifies the pulse duration (pulse width) to be used
during treatment
See the tables under Plan Parameters on page 67 for available parameter ranges and
applications for each pattern.
4.5 Treat
Once a treatment plan has been prepared as described in the previous sections, it
serves to guide the operator through the navigated treatment of the patient. However
treatment is also possible without preparing a separate treatment plan by navigated
pattern or conventional mode.
Warning: The Navilas® laser system assists the operator performing the treatment. However, the
operator is in control of the laser application throughout the treatment and needs to verify the correct
application of the laser.
Warning: It is the operator’s responsibility to check the accuracy of the overlay constantly throughout
the treatment and correct the position of the aiming beam in case of inaccuracies.
The usage of the treatment and treatment planning capabilities is restricted to

ophthalmologists.
1. Toggle button: Select desired overlay assistance; confirm message boxes; 2. Push buttons: Jump to next
/ last treatment location; 3. Trackball: Move aiming beam and acquire color image; 4. Scroll wheel: Adjust
focus
Figure 31: Usage of joystick in treatment
Warning: Except during actual treatment, the laser must always be in standby mode. Maintaining
the laser in standby mode prevents accidental laser exposure if the footswitch is inadvertently depressed.
Warning: Verify that all persons in the treatment room are wearing the appropriate laser safety
eyewear before placing the laser in ready mode. Consult the Laser Safety Eyewear section of this
operator manual for important information concerning laser safety eyewear.
Warning: To alert personnel before they enter the controlled treatment area, place a warning sign
on the outside of the treatment room door when the laser is in use.
Warning: Decontaminate the OD-OS approved treatment contact lenses before use.
Warning: Incorrect treatment settings can cause serious tissue damage. Therefore, it is recommended
to use the lowest acceptable treatment settings until the Navilas® capabilities are familiar. Use extreme
caution until the biological interaction between the laser energy and tissue is thoroughly understood.
Warning: The use of a laser is at the physician’s discretion except in cases where the application is
contraindicated.
Caution: Do not attach any objects to the control screen during laser operation. Doing so may result
in erratic operation.
4.5.1 Preoperative Instructions

Prior to treatment, verify the following:
1. Post Laser in Use warning sign outside of the treatment room door.
Ensure that all persons in the treatment room are wearing the appropriate laser
safety eyewear. To ensure their safety, all operating room personnel and all persons
assisting during treatment and in range of possible laser radiation must be informed
about and have a thorough understanding of all safety hazards, especially the specific
ocular risks and hazards. Everyone within the controlled area is at risk of accidental
laser exposure and laser reflection and must wear the appropriate laser safety
eyewear, as specified under Laser Safety Eyewear on page 23.
2. Turn on the Navilas® Laser System and log on as described in Start Navilas & Log
On on page 31.
3. Verify that the aiming beam is visible.
4. Verify that a full, clear image is visible and that the image quality is acceptable.
Warning: Ensure that the patient is well informed regarding the proposed procedure and verify that
he/she is properly positioned. An uncooperative patient or improper patient positioning may cause
poor image quality.
Warning: Since the aiming beam is coincident and follows the same path as the treatment beam
through the device head, it provides a reliable means of checking the integrity of the Navilas® Laser
System. If the aiming beam is not visible, or if its intensity is reduced or it looks diffused, it may
indicate a damaged or malfunctioning system. Do not use the laser. Call the Navilas® help desk.
Warning: Use of a contact lens other than the OD-OS approved contact lenses inhibits the view of
the patient’s retina and is prohibited. Doing so endangers the patient and operator, possibly causing
eye damage.
Before beginning the treatment process, prepare the patient and device head for the
therapy as described in the following sections:
‣ Positioning Patient and System on page 38, and
‣ Select the Imaging Mode on page 42.
In addition, place the touch-sensitive digital display (monitor) on the appropriate side
depending on which eye is to be treated.
Before moving the monitor, position the base and the device head first into the center
at the closest position to the patient. Afterwards, grab the monitor with both hands
and turn it in the direction of the operator (gently turn the monitor face toward the
device head and pull to move it to the other side). Avoid bumping the monitor into the
device head.
Figure 32: Preoperative controls on page 54 shows the controls that are used in the
preoperative phase.
1. Laser standby/ready; 2. Plan overlay; 3. Treatment Mode; 4. Open Image Gallery
Figure 32: Preoperative controls
Warning: Prior to treatment, check and validate the image quality of the live image. Verify that the
image is clear, focused, fully illuminated, and that the aiming beam is visible and moveable. Improper
adjustment may lead to undesirable photocoagulation results.
4.5.2 Start the Laser

When both patient and device head are properly positioned and a treatment plan is
loaded, the laser can be activated to prepare for treatment. Tap the Laser Status
Standby button shown in Figure 32: Preoperative controls on page 54. The button
label changes to Laser Status Ready. The image will appear slightly darker. If
necessary, adjust the light intensity. The aiming beam should be clearly visible in the
image.
Adjust the treatment parameter for the desired treatment method. The Navilas® provides
the following modes:
‣ Conventional treatment
‣ Navigated treatment (process a plan or navigated pattern)
Activate Microsecond Pulses in the Navilas® Software
The Navilas® Laser System offers different options for the deployed treatment laser. If
the Navilas® is equipped with a semiconductor laser module emitting 577nm, short
pulses can be used. To activate microsecond pulses, proceed with the following steps:
‣ Tap the Pulse Duration button by single click to enable microsecond pulses. The
background of the button label changes into grey color. The Pulse Duration button
visualizes the microsecond pulse duty cycle in case the duty cycle is enabled.
‣ Tap the Pulse Duration button by long click will open a microsecond pulse
configuration dialog to adjust microsecond pulse width, microsecond pulse pause
and duty cycle.
‣ The microsecond pulse configuration dialog can opened also in the Submenu treat.
‣ Disable microsecond pulse per single click (Microsecond pulse is also be disabled if
patient changes).
1. Press pulse duration button to enable Microsecond Pulse; 2. Longclick on pulse duration button will
open settings panel; 3. Duty cycle; 4. Example of treatment with spot spacing 0
Figure 33: Microsecond Pulse adjustment
4.5.3 Conventional Treatment

In Conventional Treatment Mode, the Navilas® navigation support is switched off.
The treatment process is entirely manual. No Treatment Plans are available to assist.
Treatment in IR (Infrared) Mode is not possible.
1. Wide Field (optical element mounted); 2. Laser power (pulse height); 3. Pulse duration (pulse width) or
microsecond pulse; 4. Spot size; 5. Treatment Mode (select pattern and parameters)
Figure 34: Treatment controls
4.5.3.1 Laser Parameter

Figure 34: Treatment controls on page 56 shows the adjustable parameters for each
pattern.
The following laser settings can be changed for each pattern using the controls at the
bottom of the treatment window:
‣ Laser power or pulse height is the intensity of the laser beam used for treatment.
The power should be adjusted according to the desired fluence. When using the foot
switch, the left button decreases and the right button increases the laser power.
Start with lower energy in the beginning of treatment, evaluate the effect and decide
to readjust. Starting with higher laser power in the beginning may lead to undesired
effects
‣ Pulse duration or pulse width: For single spots any value can be selected. If a
Conventional Pattern with more than one spot is selected, the pulse duration may
only be set in a range from 10–30ms.
‣ The spot size of the applied spots can be adjusted between 50µm and 500µm. With
Navilas®, the adjusted spot size gives the size of the spot on the retina. No additional
calculation to know the size of the spot on the retina needs to be performed.
When any of the settings are changed, the Navilas® emits a confirmation tone to indicate
that the setting has been adjusted.
4.5.3.2 Conventional Patterns

In Conventional Treatment Mode, the laser position is always adjusted manually. It is
important to take eye motions into consideration, as the treatment of a pattern may
take a few moments and the eye may move during this time. To adjust the spot or
pattern position, move the trackball on the joystick, use the mouse or touch the screen.
To treat a single spot, check the laser parameter settings and apply laser energy by
pressing the foot switch. If the Repetition Mode option is active, spots are repeated
as long as the foot switch is pressed. The space between spots and the pause between
laser pulses is determined by the Spot Spacing and Pulse Interval settings.
Table 6: Treatment patterns on page 57 provides an overview of the patterns available

for manual treatment in conventional mode. For each pattern, select the desired power,
pulse, and spot size.
When patterns are selected, laser energy is applied to the spots in the pattern as long
as the foot switch is pressed. There is no pause between spots, and each spot is treated
for 10–30 ms, depending on the Pulse Duration setting.
After a treatment of a spot or pattern, evaluate the tissue effect by using the Effect
Evaluation as described in Evaluate the Tissue Effect on page 60.
Table 6: Treatment patterns
Pattern Name Description
Single spot Each laser spot must be manually positioned. A single spot is
delivered to the target tissue when the foot switch is pressed.
Single spot repeat mode Switches on the repetition mode. As long as the foot switch is
pressed, laser pulses will be released with the specified frequency
(as determined by the Pulse Interval setting)
Rectangular pattern The rectangular pattern is typically used for a peripheral treatment
and must be manually positioned. The pattern consists of several
laser spots. All laser spots in the pattern are delivered to the target
tissue in a single depression of the footswitch.
Circular pattern The circular pattern is typically used for macula retinal treatment
and must be manually positioned. The circular pattern consists of
several laser spots. All laser spots in the pattern are delivered to
the target tissue in a single depression of the footswitch.
Arc pattern The arc pattern is typically used in macula treatment and must be
manually positioned. The arc pattern consists of several laser spots.
All laser spots in the pattern are delivered to the target tissue in a
single depression of the footswitch.
4.5.4 Process a Plan
4.5.4.1 Select a Treatment Plan

Once the treatment plan on the workflow step Plan has been created, press the trackball
on the joystick. The Navilas® software will switch to the Treat screen. The plan is
already loaded automatically. The operator can begin to position patient and device
head for treatment. If a different treatment plan is desired (e.g. with external images),
select the treatment plan from the image gallery.
1. Open the image gallery.
2. Drag the desired plan into the image viewing area.
Images that contain planned Treatment Locations or Exclusion Boundariess are indicated
by small icons at the left side of the image in the image gallery.
Note: Only images taken using the standard optical element are suitable for planning. If an image
taken with the peripheral optical element is selected as the basis for a Treatment Plan, an error message
will appear when the first Treatment Location is defined.
If Navilas® Laser System is adjusted correctly; both the original image and the planning
overlay (the image containing the Treatment Locations and Exclusion Boundaries)
should be visible. If this is not the case, there are several possible causes:
‣ The rotation of the eye or head might be incorrect (re-position the patient)
‣ The sharpness of the image might not be sufficient (adjust the focus)
‣ The illumination might be too dark (adjust the illumination intensity)
‣ Vignetting appears in the image border (readjust the device head positioning)
‣ The overlap between the Treatment Plan image and the actual live image may be
too small (readjust the device head positioning)
The default transparency intensity value can be adjusted in the submenu (long click
on menu button Treat). For laser application the overlay image must be turned to 100%
transparency. The treatment plan will remain visible. To turn the overlay transparency
down use the toggle button on the joystick.
If the Navilas® Laser System warns that the image cannot be used as a reference image,
try to select a higher quality image (e.g. an image with uniform illumination, no
vignetting and no reflections).
Check the correctness of the overlay to the live image. After verifying correct overlay
press the Toggle button on the joystick to switch off the Image Overlay. Press the
button several times to toggle between the available modes (planning image active
and visible, overlay image off). It is recommended to regularly check correct overlay
throughout the treatment procedure.
4.5.4.2 Position the Laser

During navigated treatment, the Navilas® laser Pre-Positioning feature quickly moves
the laser to the desired treatment spots that are stored in the Treatment Plan.
To aiming beam is pre-positioned on the first Treatment Location. Press the right button
on the joystick to skip Treatment Locations or use the left button to go back to the
previous Treatment Location. When Pre-Positioning is activated, the crosshair around
the aiming beam appears in green.
The planned spots are processed by quadrant (counterclockwise) starting in the upper
left corner. To achieve the greatest accuracy, try to keep the currently targeted spots
in the center of the field of view, since the deviation between aiming beam and
treatment laser increases from the center to the border of the visible image. If the next
spot in a row is outside the field of view, this spot is skipped and the next one is
processed. Reposition the device head to make any missed spots visible and use the
left button on the joystick (back) to go back. With a long click on the right button, the
Navilas® software will move directly to skipped spots.
If the software is unsure about the accuracy of placement and the exact location of
the the aiming beam, it can occur that the aiming beam is not positioned exactly to
the planned spot (the aiming beam does not move directly to the planned spot, but
slightly next to it). This can happen if the aiming beam produces strong reflexes,
vignetting occurs or a blurry or dark image is used. In these cases, the placement
should be fine-tuned manually.
After the aiming beam reached the targeted spot the operator is responsible to control
and correct the position of the aiming beam relative to the retina. The operator is under
full control of the position of the aiming beam at any time and can manually adjust the
placement of the laser. It is necessary to manually fine-tune the laser position if the
aiming beam does not move directly to a planned spot. To adjust the laser position,
move the trackball on the joystick with a light and steady pressure until the aiming
beam is directly over the planned spot.
If laser settings (e.g. spot size or pulse duration) were changed compared to the
planning settings, a yellow information window appears above the changed parameter.
If the spot size has changed and no laser energy was applied earlier to spots of this
size, the laser power is turned down to 50mW to avoid increasing the fluence on the
retina. Adjust the laser power for this spot size. For all subsequent spots of this size,
the laser power will be changed to this value. The Navilas® Laser System will not increase
laser power automatically. Correct the laser parameters to maintain fluence if necessary.
4.5.4.3 Apply Laser Energy

Laser energy can be applied by preessing the foot switch. Prior to applying laser energy
to the retina, it is recommended to check the following items:
‣ Are the laser parameter settings correct? (e.g. spot size and pulse duration)
‣ Is the position of the aiming beam relative to the retina correct?
‣ Is the overlay correctly positioned (when using navigated mode)?
Structures on the retina are visible most easily under white light illumination. The
treatment procedure differs depending on the type of treatment pattern (single spot
or multiple-spot pattern).
Warning: For optimum photocoagulation ensure proper focus prior to treatment.
Warning: The treatment parameters, the laser position and all laser settings are the sole responsibility
of the operator. The software does not analyze treatment parameters to identify inappropriate settings
or checks for the safety of laser setting combinations. The operator must thoroughly understand laser
tissue interactions and power settings for specific laser wavelengths and systems. Use extreme caution
until the biological interaction between the laser energy and tissue is thoroughly understood.
To treat a single spot press the foot switch and apply laser energy. Keep it pressed for
the full duration of the laser burst. If the foot switch is lifted earlier, the laser energy
application is interrupted immediately.
After laser energy application, the aiming beam will automatically advance to the next
spot if Pre-Positioning had been used to target a Treatment Location.
The treated spots will change color from green to yellow. This serves to document the
spots that have been treated and to distinguish them from untreated spots. These
treatment locations cannot be changed anymore in the Plan phase. If the position of
the aiming beam can be reliably detected, a circle appears around the location of laser
application.
To treat a multiple-spot pattern:
‣ Press the foot switch and apply laser energy. Keep the foot switch pressed.
‣ The pattern will be processed in a repeat mode (with an adjustable pulse interval)
and the specified pulse duration.
‣ During the application, lifting the foot switch interrupts the laser application. Always
observe carefully the position of the aiming beam and correct or interrupt if
necessary.
‣ Spots in the pattern that have been treated change color from green to yellow.
Once the treatment patterns have been selected, the Navilas® Laser System can assist
the user by Pre-Positioning the laser beam to the next pre-selected treatment location.
After starting the laser the aiming beam is indicated with a green cross hair to indicate
that is active, however in each case the laser must be positioned manually. To adjust
the spot or pattern position, move the trackball on the joystick. When treating patterns,
a quick motion can be used to jump the distance of a pattern (or a spot). Alternatively
press the right or left paddle that the spot or pattern jump from one position to the
next.
In the pattern mode the operator can adjust the pulse interval between each spot of
a pattern. For pulse intervals of larger than 160ms each spot of the pattern can be
stabilized. In this mode any pulse duration can be selected. For patterns with a selected
pulse interval of below 160ms the pulse duration is limited to 10-30ms for each spot.
Press the foot pedal and keep it pressed for the full duration of the laser burst. Releasing
the foot pedal will immediately interrupt laser energy. Always observe carefully the
position of the laser during laser release and interrupt in case of eye movements.
Each spot that is applied to the retina will be marked up by a light blue circle to indicate
where spots have been applied. This identifies the next treatment location more easy.
These spots will be kept visible as long as possible. After a larger field of view shift,
the treatment locations will be stored in the database.
4.5.5 Evaluate the Tissue Effect

For automatic treatment evaluation a rectangle with a green frame (Picture-in-picture)
is displayed in the live area after each single spot and pattern that have been treated.
The Picture-in-picture illustrates the treated area of the retina and gives the operator
an idea of the intensity of the burn in order to produce the intended effect.
The image area (Separated window) in the lower left of the display visualizes the
before-after change of the treated area in color mode. This visual check based on a
color image permits the adjustment of the laser settings if necessary before proceeding
to treat additional areas.
Auto Treatment Evaluation can be easily switched off (and on again) during treatment
in order not to interrupt the treatment by clicking inside the Separate window.
For manual treatment evaluation press the trackball on the joystick. This will acquire
a color snapshot of the retina and display it until the trackball is pressed a second time.
To achieve a higher quality snapshot press the trackball on the joystick and keep it
pressed. The laser is switched off in that moment and a readjustment of the system
can be done. When releasing the trackball a color snapshot is taken.
1. Separate window; 2. Switch Treatment Evaluation on/off; 3. Picture-in-picture; 4. Selected treatment

mode
Figure 35: Treatment Evaluation
See Advanced Functions on page 64 for details.
Warning: Always carefully observe the laser application and tissue effects during treatment.
4.6 Report
Once treatment is completed, reports can be printed to document the results of the
treatment.
4.6.1 Create Reports

Figure 36: Reporting controls on page 61 shows the available options on the Reporting
screen.
1. Report display; 2. Image gallery; 3. Print report; 4. Add text to report; 5. Next Patient button
Figure 36: Reporting controls
If the Report screen is accessed after a treatment has been performed, a report will
be created automatically with treatment statistic, treatment plan and last acquired
treatment evaluation image. If no treatment was performed this day an empty report
will be shown. If several reports of the same day of a certain patient exist, the last
created report will be displayed.
The shown report can be modified. Further images can be added to an existing report
as well a second report can be created:
1. To add images to the report, open the image gallery and drag and drop the desired
images into the report. Drag and drop a second image (the Treatment Location
Record) directly on top of the image to create a registered comparison with
Navigation Functions.
2. To add a further images, drag and drop the desired images onto an empty area of
an existing image. Repeat this procedure until each desired images is added to the
report.
3. Activate text-editing mode by tapping the Text button, and then tap the image to
which a comment shall be added. If an empty space in the report is clicked, a general
text comment can be entered, which is not associated with a specific image.
4. Click the Print button. Number of copies can be specified in the print dialog.
5. To remove an image from the report, click the image and deselect either the
registered image or the image itself in the resulting window.
6. Use the report view controls on the right of the screen to adjust the report display
(zoom in or out, add second report, administrate report).
The report will be saved automatically.
4.6.2 Manage Reports
1. Create new report; 2. Administrate report; 3. Delete report
Figure 37: Further reporting controls
The reports will be saved automatically and sorted by creation date. If more than one
report exists per patient and date, the reports are automatically numbered.
1. Open the report by clicking on the Administrate report button. All reports created
of that patient are listed. Select a report by click.
2. To change an older report, create a copy. The copy is created under the current
date.
3. To create an additional report, press the New report button.
4. To remove a report, click Delete.
Chapter
5
User Interface Reference
Topics This chapter provides details on the Navilas® settings and
describes the commands available in each workflow step. For
‣ Image Gallery and Compare a more high-level view of the hardware buttons and software
Mode user interface components, see Navilas Laser System User
‣ Advanced Functions Interface Overview on page 14.
‣ Plan Parameters
‣ Treatment Settings Ranges
‣ Export Data
64 User Interface Reference
5.1 Image Gallery and Compare Mode

The Image Gallery (accessible via the button next to patient date of birth) contains all
images acquired for this patient sorted by acquisition date and session type (imaging
and treatment). The Compare Mode can be opened via the button in the lower left.
1. Open Compare Mode; 2. Session selection; 3. Open Image Gallery
Figure 38: Image Gallery and Compare Mode
Selecting images for different purposes from the image gallery can be done either by
drag and drop of the images into the review area or with a click on the images. With
a long click on any image, this image will be highlighted in green color and can be
deleted by clicking the trashbin next to the session date.
With the Compare Mode up to four images can be reviewed and compared to each
other. With a click in any image, this image will be highlighted in green and is selected
to be compared with another image. The overlay intensity can be adjusted according
to the operator's needs.
5.2 Advanced Functions

An additional submenu can be opened by long clicking on the workflow button in the
upper right of the screen. Additional options and information will be accessible.
The following submenu entries can be found under each workflow step:
About
This section shows information on the software version and the serial numbers. This
information should be presented to the Navilas® help desk on request.
License Info
User Interface Reference 65
This section shows information on the licence agreement with the hospital.
Back up (Back up is not displayed under Image and Treat)
The back up submenu is only available if the operator is currently logged in as an
administrator or as Service. The commands in the submenu can be used to create a
backup of the patient information contained in the database.
The backup copy can be created internally on the Navilas® Laser System or on an
external hard disk drive connected to the USB port. See Back Up of the Patient Database
on page 75 for details.
Transfer Equipment Data
Copies equipment data to the Navilas® flash drive to update the Access key. See Access
Key and Equipment Data on page 75 for details.
Export Logfiles for Technical Data
Copies log files to a connected USB or flash drive in order to transfer data to OD-OS
for Technical Service or failure analysis.
Settings
An additional dialog is opening where several settings affecting different aspects of
each workflow step can be adjusted according desired treatment paradigms.
Remote Service (Remote Service is not displayed under Treat)
This sub menu entry allows to give a service technician access the the Navilas® Laser
System. An internet connection needs to be available in order to start the connection.
Start the remote service session while click on “remote service” in the submenu. Call
the OD-OS Service technician and provide him with the password and the ID displayed
on the system.
Service Exit
A separate box will open and a pin entry is required to leave the Navilas® Software.
Only an OD-OS–certified service technician is allowed to enter the Service Exit.
Additional submenu entries are accessible under Image, Treat and Report:
Non-Myd Snapshot Intensity and FA Snapshot Intensity
Adjusts the flash brightness during color image acquisition.
FA Camera Gain
Adjusts the sensitivity of the fluorescein acquisition camera. This value can be adjusted
to increase or decrease the brightness of an image.
Color Conversion Parameter
When the Image Parameters option is selected from the submenu, a new dialog
opens which can be used to change the brightness and the color of the currently selected
image by adjusting the slider position.
Aiming Beam Intensity
The aiming beam intensity can be adjusted in four steps. Doing so can reduce halos
around the aiming beam. Increasing the intensity of the aiming beam increases the
visibility of the beam on the target tissue.
Overlay Image Intensity
In comparison mode, a secondary image can be overlaid onto the baseline image. The
transparency of the overlay image is by default 50%. The submenu entry allows the
operator to change the transparency of the secondary image from between 0% (overlay
off) to 100% (making only the secondary overlay image visible).
Treatment Evaluation
This submenu entry opens a separate dialog to adjust the preferred settings for
evaluating the tissue effect. The operator can configure automatic treatment evaluation
separately for focal and peripheral treatment. A preferred “display position” can be
selected. The operator can choose the display of the “picture-in-picture”, the “separate
window” or both. For manual acquisition a pre-view mode can be defined (either color
or IR).
1. Enable treatment evaluation for focal and peripheral treatment; 2. Select display position
Figure 39: Auto Treatment Evaluation settings
Microsecond Pulses
This submenu entry opens a separate dialog to adjust the Microsecond pulse parameters
(only with Navilas® 577+ or 532+). The operator can adjust microsecond pulse settings
for pulse duration and pulse pause. The preferred duty cycle can be defined by clicking
the equivalent button.
1. Adjust pulse duration; 2. Adjust pulse pause; 3. Define duty cycle
Figure 40: Microsecond Pulse settings
Show Printing Monitor

This entry shows status of the printing monitor.
Report Header
The site details are used to define the information that appears in the header of the
printout.
5.3 Plan Parameters
Table 7: Rectangular and hexagon pattern parameter ranges
Parameter Range Description
Spot Number Adjustable in single increments: 2x2 The spot number parameter specifies the
spots; 3x3 spots; 4x4 spots; 5x5 spots; number of treatment laser spots applied
etc. during a single activation of the footswitch.
The spot number parameter greatly affects
the size of the treatment pattern—the
higher the number, the larger the
treatment area.
Spot Size 50µm – 150µm (steps: 10µm); 150µm –

500µm (steps: 50µm)
Spot Spacing Adjustable in 0.25 increments from -0.25 The spot spacing parameter indicates the
to 6 distance between each spot based on spot
size. For instance, if the spot spacing value
For Feeder Vessel pattern adjustable in
is 1, then the distance between each spot
0.25 increments from -0.5 to 1.00
is equivalent to one spot size.
Table 8: Circular pattern parameter ranges
Spot Size 100-150µm (steps: 10µm); 150-500µm

(steps: 50µm)
Spot Spacing adjustable in 0.25 increments from -0.25 The spot spacing parameter indicates the
to 6 distance between each spot based on spot
size. For instance, if the spot spacing value
is 1, then the distance between each spot
is equivalent to one spot size.
Inner Diameter adjustable in 50µm increments from The default inner diameter value is 500µm.
500µm to 3000µm This parameter is in the sub menu.
The arc pattern parameters are very similar to the circular (ring) pattern parameters
described in Table 8: Circular pattern parameter ranges on page 68, except that the
user can adjust the arc rotation and pattern angle.
Table 9: Arc pattern parameter ranges
Grid Size (number Adjustable in steps of 1, 2, 3, 4 and 5. Specifies the number of treatment laser
of arc segments) spots applied during a single activation of
the footswitch. The ring number parameter
greatly affects the size of the treatment
pattern—the higher the number, the larger
the treatment area.
Spot Size 100-150µm (10µm steps); 150 – 500µm

(50µm steps)
Spot Spacing Adjustable in 0.25 increments from -0.25 Indicates the distance between each spot
to 6 based on spot size. For instance, if the
spot spacing value is 1, the distance
between each spot is equivalent to one
spot size.
Inner Circle Adjustable in 50µm increments from The default inner diameter value is 500µm.
Diameter 500µm to 3000µm This parameter is available from the
submenu.
Arc Rotation Adjustable in 20° steps The arc rotation parameter is used to
rotate the arc.
Pattern Angle Plate Adjustable 45° and 90° This parameter indicates the segment size
Default Settings and optional pulse duration planning can be adjusted in advance
according to the operator's preference:
1. Open the submenu with a long click on one of the workflow buttons.
2. Click Settings and mark the Checkbox "Use Pulse Duration Planning".
3. Adjust further settings for plan parameters and click ok.
5.4 Treatment Settings Ranges
Table 10: Laser setting range
Laser Power 50mW–2000mW Power adjustable from 50mW to 2000 mW in the

following increments:
50 mW–200 mW: in 10 mW steps
Laser power of >1200mW cannot be adjusted
for all spot sizes
Pulse Duration 10ms–4000ms The pulse width for patterns can only be set
between 10ms and 30ms.
Spot Size (standard 50µm–500µm The spot size (also called zoom) is adjustable
optical element) from 50 µm to 500 µm in the following
increments:
50 µm to 150 µm: steps of 10 µm150 to 500 µm:
steps of 50 µm
Spot Size (peripheral 75µm–750µm Used together with peripheral contact lens
optical element)
Repeat Mode: Pulse The following steps are This parameter defines the pause in between two
Interval Setting available: pulses in the single spot repetition mode.
10ms-300ms: 10ms
300ms-500ms: 20ms
500ms-1000ms: 50ms
1000ms-3000ms: 100ms
3000ms-5000ms: 200ms
1. Focal treatment; 2. Select Navigated Mode (or Conventional Mode) as default; 3. Peripheral treatment
Figure 41: Adjust default settings for focal and peripheral treatment
5.5 Export Data
1. Export button with export options; 2. Export window
Figure 42: Export on report screen
Data can be exported from the Navilas® Laser System on the report and patient screen.
‣ Patient: When a patient is selected, all images for the current patient are exported
(without Treatment Plans or Treatment Location Records). If a date is selected, the
patient’s images from this session will be exported. If a set of images is selected,
only these images are exported.
‣ Report: All images included in the report will be exported. These may include images
with Treatment Plans, Treatment Location Records or overlaid images.
Click the Export button on the report or patient screen on the toolbar in the right of
the screen. A dialog appears to select the desired exporting options:
‣ Destination: Export of images to an USB stick or to a network location defined by
the user.
‣ Type: Either stores the images from the image review area or acquires a full screen
shot, or the report as seen.
‣ Format: Defines the image format.
‣ Make patient data anonym.
‣ Export Patient data into a subfolder.
‣ Click the Cancel button in order to cancel the report.
After clicking OK, a progress bar is shown until the export is completed.
Chapter
6
Maintenance & Administration
Topics This chapter outlines the patient data administration process
and describes the maintenance procedures necessary to
‣ Clean the Navilas Laser ensure that the Navilas® Laser System functions properly.
System
‣ System Settings Warning: Only OD-OS–certified service technicians must service /
repair the Navilas® Laser System. No other personnel are allowed to
‣ Access Key and Equipment open covers or housings that are secured by screws.
Data
‣ Back Up of the Patient
Warning: Under no circumstances must the Navilas® Laser System
Database be used if there are suspected or verifiable mechanical, electrical, or
‣ Restore the Patient optical errors.
Database
‣ Maintenance
Warning: If the operator notices any unusual noises, vibrations, or
‣ Long Term Storage mechanical or software abnormalities, they must be reported
‣ Disposal immediately to the Navilas® help desk. Do not use the Navilas® until
it has been serviced. Do not, under any circumstances, attempt to
‣ Troubleshooting Guide inspect or repair the Navilas® Laser System without assistance.
72 Maintenance & Administration
6.1 Clean the Navilas® Laser System
Warning: Do not use fluids or wet tissue to clean the Navilas®. Strictly follow the cleaning and
maintenance instructions as provided in this operator manual.
Warning: Do not use abrasive cleaning tissue or fluids to clean the optics.
Warning: High temperatures produced in normal use of the laser equipment may ignite some materials
(e.g. cotton wool when saturated with oxygen), and solvents of adhesives and flammable solutions
used for cleaning and disinfecting should be allowed to evaporate before the Navilas® Laser System
is used.
Protect the Navilas® Laser System against dust, humidity and liquids to avoid impacts
on functionality and operation of the system. When cleaning the system, turn it off and
disconnect the power cable.
After each treatment, disinfect the operator and patient contact areas on the Navilas®
Laser System, including the chin and the armrest. Commercially available disinfecting
agents may be used. OD-OS recommends using 70% alcohol to clean the system
(except the lens).
Be careful not to scratch the control screen. Also be careful not to inadvertently
contaminate the laser aperture or the cooling slots with any kind of debris or fluids.
Take care not to scratch the front lens of the device head.
The OD-OS approved treatment contact lenses must be cleaned and disinfected prior
to use, as described in the accompanying documents of the contact lens.
The camera lens may be cleaned if necessary with great care. Use the lens cleaning
tissue provided with the Navilas® Laser System to cleaning the front lens. The cleaning
frequency should be determined by the intensity of dust in the surrounding environment.
When cleaning, do not touch the lens with the fingers and do not use hard items for
cleaning stiff or scratchy cleaning cloths that may scratch the surface of the lens. To
properly clean the camera lens, do the following:
‣ Blow contaminants off the front lens and the accessible mirrors. Initially aim an air
stream away from the lens. While aimed away, start the air stream using a moderate
airflow. Maintain an oblique angle to the lens; never blow the air directly
perpendicular onto the front of the lens surface. Now bring the air stream to the
lens, and slowly move it across the surface, keeping the flow at an oblique angle
while removing the dust. Return the stream back across the surface. Repeat until
no more loose particles are disappearing.
‣ If dust or debris remains, it is probably “stuck” to the surface and must be removed
with mechanical force and/or chemical action. Create a firm but “pointy” tip with a
lint-free wipe or lens tissue by folding it multiple times into a triangular shape or
wrapping it around a swab. Lint-free swabs may also be used in place of a folded
wipe. Moisten the wipe or swab with acetone, while avoiding using excessive solvent.
If the wipe or swab is fully saturated, it should be gently shaken to remove any
excess solvent.
‣ The key to cleaning the optic lens is to maintain one continuous motion at a speed
as constant as possible. Start in the center of the lens and wipe outward in a spiral
pattern. If the wiping motion is stopped at any point, it is likely that residue will
remain on the surface at that point; therefore, move the wipe at a constant speed.
Maintenance & Administration 73
‣ Lift the wipe as it approaches the edge of the clear aperture (or the optic mount),
but don’t stop the wiping motion until the tip is well off the surface of the lens.
‣ Inspect the optics. Use a room light or any bright light source to inspect the lens to
ensure that it is clean. If contamination remains, start with a brand new wipe or
swab and repeat step 2 above. For every new cleaning attempt, ALWAYS use a new
wipe!
Wipe the surfaces of the table, device head, controls, and display with a damp cloth.
Commercially available disinfecting agents may be used. OD-OS recommends using
70% alcohol for cleaning the Navilas® Laser System (except the lens). Take care not
to scratch the window of the display or to contaminate the opening of the laser aperture
with any kind of debris or fluids. Take care not to use fluid in or around the cooling
slots. Do not touch the front lens.
Trackball Cleaning
After longer usage the trackball might become dirty due to fluids, gels and dust. A dirty
trackball might lead to an unreliable working of the aiming beam positioning. If this
occurs clean the trackball as described as follows:
1. Grab the front part of the green section on top of the joystick
2. Gently lift the element
3. Pull the trackball out of the cover
4. Blow dust from the trackball and remove other containments.
5. Replace the trackball into the housing and push it into the joystick housing.
6.2 System Settings
6.2.1 Network Drive Configuration

The Navilas® Laser System is able to export to a user defined network location as well
as to import from a network location. In order to access these network drives the
operator has to establish the configuration. To configure a network drive proceed as
follows:
1. Open the submenu with a long click on one of the workflow buttons and click on
settings. A new dialog as shown in Figure 43: Network settings dialog on page 74
appears.
2. To add a new network drive click on “Add” and “Edit” to change the settings of an
already configured network drive.
3. A new dialog appears as shown in Figure 43: Network settings dialog on page 74
appears. Enter a short name for the network drive e.g. ImageManagement and add
the correct path e.g. \\server\folder
4. When accessing a network drive a specific user name must be given (e.g. JohnS).
5. Click on “Test” to verify if Navilas® Laser System is able to access the network drive.
The system prompts a password to access the network drive, this may be empty or
any password dependent on the IT structure of your clinic.
6. The Navilas® will maintain the network settings except for the password, which you
need to reenter once after a start of the system, as soon as needed.
Figure 43: Network settings dialog
6.2.2 Export Settings

Prior to export images a dialog is opening to adjust the parameters “Export Drive”
(Where to store to) “Capture Mode” (images or screenshot) and the File Format. To
constantly change the pre-settings for this dialog open the submenu with a long click
on one of the workflow buttons and click on settings.
6.2.3 Preferred Parameter Settings

Each user may have preferred settings in the workflow step Plan or Treat. To adjust
the pre-settings open the dialog “Settings” from the submenu in the workflow step
Treat and select either Plan or Treat.
In the Plan section, you can adjust each parameter that you have available during the
planning phase. Select the desired parameter and click ok to exit and store the new
default settings.
The defaults in the workflow step Treat can be adjusted for 3 different situations.
‣ Focal treatment: Defaults will be applied as soon as the Standard optical element
is connected to the system
‣ Peripheral treatment: Defaults will be applied as soon as the peripheral optical
element is connected to the system
‣ Conventional treatment: setting is independent from the optical element selected
for the “Conventional” treatment mode.
Adjust the desired parameter and click ok to store the preferred settings.
6.3 Access Key and Equipment Data

The Navilas® Laser System can only be used with a valid Navilas® Access Key. The
Image and Plan workflow steps are only available when the Navilas® Access Key is
attached. The key must be updated in regular intervals as determined in a specific
contractual agreement.
6.3.1 Transfer Equipment Data from the Navilas® Laser System

to OD-OS
Before the Equipment Data can be transferred to OD-OS, it must be transferred from
the Navilas® Laser System to the Navilas® flash drive or any other USB memory stick.
1. Connect the Navilas® flash drive or any other USB memory stick to the Navilas®
Laser System.
2. Open the submenu with a long click on one of the workflow buttons.
3. Click Transfer Equipment Data. When the equipment data has been moved to
the flash drive, a message confirms the action.
6.3.2 Update the Access Key

Use the Navilas® Access Key Update Manager to update the Access Key and reattach
the Access Key to the Navilas® Laser System. The system will than resume operation.
6.4 Back Up of the Patient Database

To ensure data integrity in the event of system failure, periodically back up the patient
database either to the internal hard disk in the Navilas® Laser System or to an external
hard disk drive attached to the system via USB.
6.4.1 Internal Backup

The internal backup is automatically performed upon shut down of the system. To start
the internal backup manually, select Backup > Internal Backup from the submenu
Patient with a long click on one of the available workflow buttons.
When the first backup is created, a full backup is performed, so the process may take
a long time. All subsequent backups will be performed incrementally, recording only
the changes since the last backup.
6.4.2 External Backup

To ensure the database is backed up regularly, specify an interval after which the
system will remind the operators to perform a backup.
To set a reminder, select Backup > Options from the Patient submenu and specify
a reminder interval. The time can be set between 0 days (no reminder) and 999 days.
When the specified interval expires, the system displays a reminder message at logout.
Dismiss the message to back up later, or begin the backup immediately.
To perform an external backup:
1. Attach an external hard disk drive to the USB port of the Navilas® Laser System. To
ensure sufficient backup capacity, OD-OS recommends using a drive with 500 GB
capacity or larger.
2. From the submenu Patient, select Backup > External Backup.
3. Follow the instructions on the screen.
If the external disk is empty, a full back up is started. If an older backup is detected
on the disk, an incremental backup will be performed.
6.5 Restore the Patient Database

If a backup copy of the patient database has been created as described in the previous
section, an operator (logged in as Administrator) can revert to an earlier version of the
database to restore the patient data from the backup.
Please note that any records created after the backup will be lost when restoring patient
data, as the backup represents a snapshot of the database contents at the time the
backup was created.
In order to begin the restore process, the operator must be logged in as an
administrator.
To restore the database from a previous backup:
1. From the submenu Patient, select Backup > Restore Backup (either internal or
external).
2. To restore an external backup, attach the hard disk drive containing most recent
backup to the USB port of the Navilas® Laser System.
3. Follow the instructions on the screen.
6.6 Maintenance
Warning: Do not operate the Navilas® Laser System in the proximity of strong vibrations or
electromagnetic fields. These influences can interfere with the system, causing system damage or
improper operation.
6.6.1 Fuse Replacement

‣ Switch off via the key switch and unplug the mains cable.
‣ Open the fuse holders next to the mains cable connector on the back panel and
check the two fuses.
‣ Replace blown fuses with fuses of exactly the same size and values as indicated on
the back panel fuse label.
6.6.2 Preventive Maintenance & Calibration

Regular preventive maintenance checks are necessary to avoid critical system failures,
which may endanger patients and operators.
According to the regulations governing medical products, this preventive maintenance
check may only be performed by authorized and trained personnel. The service interval
may vary from country to country.
Contact the Navilas® help desk when the Navilas® is due for service to schedule support
and security checks. It is the operator’s responsibility to ensure that the Navilas® Laser
System is operated and maintained in accordance with regulations.
During the preventive maintenance check, the following tasks will be performed:
‣ Verify power levels of the laser beam, light and laser safety
‣ Functional check
‣ Electrical safety check
Calibration is a service procedure to be performed only by OD-OS–certified service
technicians. The calibration process comprises an optical alignment, a laser calibration,
and light calibration.
6.7 Long Term Storage

The Navilas® Laser System will be stored by OD-OS if required. OD-OS will take care
of appropriate measures such as cleaning the system, packaging and environmental
conditions (non-condensing, temperatures and humidity requirements).
6.8 Disposal
As required by the directives 2002/96CE and 2003/108/CE, OD-OS is responsible for the
disposal of the Navilas® Laser System. The operator is not allowed to dispose of the system
or its accessories.
Please note that the product does not contain any dangerous material. Its disposal will not
damage the environment.
6.9 Troubleshooting Guide
Warning: In the event that the computer fails or stops working during Image or during a treatment,
the system may produce poor image quality and unintended treatment results.
Problem Cause Measure
Navilas® could not be Power is not available, or Check all cable connections to the Navilas® and verify
switched on. a cable may have been that the cables are correctly plugged in. Verify that
accidentally disconnected. power is available. Check the fuses as described
under Fuse Replacement on page 77. If power is
available, all cables are plugged in, and the fuses are
operational, but the Navilas® Laser System still cannot
be switched on, contact the Navilas® help desk.
Live image is not visible. The light source or the Contact the Navilas® help desk.
camera is defective.
The software may not be Reboot the system. If the problem persists, contact
detecting the camera. the Navilas® help desk.
The illumination intensity Switch to color imaging mode, rotate the knob on
is set to 0. the head clockwise and adjust the illumination
intensity to level 10. If rotating the knob does not
increase the light intensity, press the knob. If no
measures help, contact the Navilas® help desk.
Laser cannot be applied The fiber is broken. If the aiming beam is not visible, the laser fiber may
as desired to the retina. be broken. Contact the Navilas® help desk.
The device head is not If the operator expects a laser effect on the retina,
accurately positioned. but does not observe anything, the Navilas® Laser
System might be improperly positioned. In this
scenario, some laser power might be absorbed by
the treatment contact lens.
The treatment window is Select the Treat workflow step and switch on the
not the active window on laser. Moving to another workflow step deactivates
the control screen. the laser.
Laser parameter may not Ensure that the laser parameter is set correctly. If
be set correctly. the problem still persists, contact the Navilas® help
desk.
Training mode is active. Check if the training mode is activated which is

indicated by a green background in the graphical user
interface.
Report cannot be printed. The printer is not Please check that the printer is properly connected
switched on or not to the Navilas® Laser System, connected to an
plugged in. electrical power source, and switched on.
The printer is out of Load paper in the printer paper tray.

paper.
The printer ink cartridge Check the printer ink level and, if necessary, insert
is empty. a new ink cartridge.
Aiming beam is not or The laser fiber is broken. Select the Treat workflow step and verify that the
only half visible. laser is on. If the laser is active and on but the aiming
beam still is not visible, contact the Navilas® help
desk.
The laser is not switched Select the Treat workflow step and switch on the
on. laser. Moving to another workflow step deactivates
the laser.
The aiming beam is Target the aiming beam in the center of the live
positioned outside the image using the touch sensitive display.
camera’s visual field.
The aiming beam is not Contact the Navilas® help desk.

correctly calibrated.
The aiming beam cannot The scanner is broken or Contact the Navilas® help desk.
be moved. the cable is disconnected.
The trackball is dirty. Clean the trackball according to the instructions in

Clean the Navilas Laser System on page 72.
Fiber is not detected. The fiber is loose or not Open the cover of the electronics housing and fasten
correctly attached. the fiber correctly.
The base cannot be The joystick is blocked. Check if any objects are within the movement range
moved. of the base.
The base brake is Loosen the brake using the head element switch or
activated. the joystick switch.
There is no light coming The light source is Switch on the imaging, set the light power to 100%,
out of the device head. switched off or set to low set the mode to color (myd), and check if light is
power. coming out of the device head.
The light source is Contact the Navilas® help desk.

broken.
Laser did not start or The laser exceeded its Let the laser cool down for 30 minutes, and verify
stopped working. temperature limit. that the fans are working. After 30 minutes, try again.
If the laser still does not work, contact the Navilas®
help desk.
The Door Interlock is not Open the green cover on the electronics housing and
attached to the Navilas® check if the door interlock is attached. Reattach if
Laser System. needed.
A software error message A data communication Shut down the laser system and restart it. If the error
appears. error may have occurred. message reoccurs, contact the Navilas® help desk.
The image appears The front lens might be Clean the front lens according to the instructions in
blotched or partially dirty. Clean the Navilas Laser System on page 72.
blurred.
Reflexes appear centrally The front lens might be Clean the front lens according to the instructions in
in the image. dirty Clean the Navilas Laser System on page 72.
Spot counter is not The laser might not be Check if laser is correctly working.
counting. active.
Appendix
A
Appendix
Topics
‣ Specifications
‣ Compatible Accessories
‣ Suggested Reading
‣ Acronyms and Abbreviations
82 Appendix
A.1 Specifications
Warning: The OD-OS Navilas® Laser System is a Class I, Type B protection class device according
to IEC 60601-1. Therefore, the Navilas® is protected by an additional protective conductor system;
parts that can be touched are connected to ground.
The ingress protection classification as defined by IEC 529 is IP20.
A.1.1 Power Supply

The Navilas® Laser System works with a 115/230 VAC electrical power source. The
system must always be connected to a grounded power supply.
In order to isolate the Navilas® Laser System electrically from the mains supply, remove
the main power plug from the electrical outlet.
Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
A.1.2 Dimensions
®
Table 11: Navilas dimensions
Item Dimensions
Complete System Height 127 cm – 230 cm

Depth 83 cm
Length 126 cm
Table Height 68 cm – 103 cm

Depth 83 cm
Length 126 cm
device head / device base Height 50 cm ~ 20 inches

Length 70 cm ~ 26 inches
Depth 40 cm ~ 16 inches
A.1.3 Transport and Ambient Conditions

Please verify whether the current contract permits transporting the Navilas® Laser
System. The Navilas® Laser System must be transported in its original packaging.
Ensure that the ambient conditions as specified below are met during transport and
operation of the laser.
Appendix 83
Table 12: Operating conditions
Circumstances Conditions
During Operation Operating temperature + 15 – +28 C

Relative humidity up to 85%
Atmospheric pressure 700 – 1200 mbar
Transport / Storage Temperature + 5 – +60 C (no frost)

Relative humidity max. 90%
Atmospheric pressure 700 – 1200 mbar
Warning: The system must not be submitted to atmospheric pressure or temperatures exceeding
the values listed in this operator manual. Transport in airplanes should be under thermal and pressure
adapted conditions.
Warning: Only operate the Navilas® Laser System within the proper environmental conditions. Doing
so will prevent environmental damage to the system, and ensure appropriate therapeutics and
diagnostics.
A.1.4 Laser Specifications
1. Green or yellow Power Laser generator; 2. Laser diode; 3. Laser crystal (Nd:YVO) or OPS-Chip; 4. Frequency
doubling crystal; 5. Collimating Lens; 6. Red aiming beam laser and path (635nm); 7. Beam Splitter; 8.
Fibre Connector and Fibre of delivery device; 9. Output beam (532nm + 635nm or 577nm + 635nm); 10.
Treatment Beam Path; 11. Treatment laser power measuring diode; 12. Coupling lens
Figure 44: Therapy Laser Unit in Control Box
84 Appendix
1. Zoom unit; 2. Optical fibre; 3. Laser unit; 4. X-Y scanner; 5. Optical element; 6. Intermediate image
plane; 7. Contact lens; 8. Eye
Figure 45: Beam path of Therapy Laser
A.1.4.1 Aiming Beam
Table 13: Aiming beam specifications
Item Description
Laser type Diode laser
Laser class II
Wavelength 635nm
Max. average power <1mW
Pulse duration 0.1 – 4ms
A.1.4.2 Treatment Laser
Table 14: Treatment laser specifications
Item Description
Laser type Diode-pumped, solid state frequency-doubled Nd:YVO
Laser class IV
Wavelength 532nm or 577nm (tolerance zone: ± 2nm)
Laser power 50mW up to 2000mW (tolerance zone: ± 20%)
Pulse duration 10ms up to 4000ms (tolerance zone: ± 1ms)
Appendix 85
Item Description
Pulse interval time 160ms up to 4000ms (tolerance zone: ± 1ms)
Spot sizes 50µm– 500µm (tolerance zone: ± 5%)
Beam divergence 3 mrad up to 30 mrad
NOHD 13 m up to 130 m
Laser hazard area comprises the room the laser is set up.
A.1.4.3 EMC Data and Guidelines
Warning: Medical electrical equipment needs special precautions regarding EMC. The following EMC
guidelines must be observed during installing and commissioning of the Navilas® Laser System
Warning: Portable and mobile RF communications equipment can affect medical electrical equipment.
Guidance and manufacturer's declaration – electromagnetic emissions
The Navilas® Laser System is intended for use in the electromagnetic environment specified below. The
operator of the Navilas® Laser System has assured that it is used in such an environment.
Emission test Compliance Electromagnetic environment–guidance
RF emissions acc. to CISPR 11 Group 1 The Navilas® Laser System uses RF energy only for
its internal functions. Therefore, its RF emissions are
very low and are not likely to impair nearby electronic
equipment.
RF emissions acc. to CISPR 11 Class B The Navilas® Laser System is suitable for use in all
establishments including those in living areas and
those directly connected to the public low-voltage
power supply network that also supplies buildings
used for living.
Harmonic emissions acc. to IEC Class A

61000-3-2
Voltage fluctuations / flicker Complies

emissions acc. to IEC 61000-3-3
Guidance and manufacturer declaration – electromagnetic immunity
client or operator of the Navilas® Laser System must ensure that it is used in such an environment.
Immunity test IEC 60601-1 test Compliance level Electromagnetic

level environment–guidance
Electrostatic discharge +- 6kV contact +- 6kV contact Floors should be wood, concrete or
(ESD) acc. to discharge discharge ceramic tile. If floors are covered
with synthetic materials, the
IEC 61000-4-2 +- 8 kV air discharge +- 8 kV air discharge
relative humidity should be at least
30%.
Electrical fast +- 2 kV for power +- 2 kV for power The quality of the supply voltage
transients/ burst acc. supply lines supply lines should correspond with one
to characteristic for a typical
+- 1 kV for input/ +- 1 kV for input/
commercial or hospital
IEC 61000-4-4 output lines output lines
environment.
86 Appendix
Immunity test IEC 60601-1 test Compliance level Electromagnetic

level environment–guidance
Surge acc. to IEC +- 1 kV differential +- 1 kV differential

The quality of the supply voltage
61000-4-5 mode mode should correspond with one
characteristic for a typical
+- 2 kV common mode +- 2 kV common mode
commercial or hospital
environment.
Voltage dips, <5% for 5s <5% for 5s The quality of the supply voltage
short-term should correspond with one
<5% for 0.5 periods <5% for 0.5 periods
interruptions and characteristic for a typical
voltage variations on 40% for 5 periods 40% for 5 periods commercial or hospital
power supply input environment. If the user of the
70% for 25 periods 70% for 25 periods
lines acc. to IEC Navilas® Laser System requires a
61000-4-11 continuous function of the
appliance also during interruptions
of the power supply it is
recommended to supply the
Navilas® Laser System out of an
uninterruptible power supply or a
battery.
Power frequency 3 A/m 3 A/m Power frequency magnetic fields

(50/60Hz) magnetic should be at levels characteristic
fields acc. to IEC for commercial or hospital
61000-4-8 environments.
Guidance and manufacturer declaration – electromagnetic immunity
operator of the Navilas® Laser System must ensure that it is used in such an environment.
Immunity test IEC 60601-test level Compliance level Electromagnetic

environment–guidance
Portable and mobile RF

communications equipment should
be used no closer to any part of
the Navilas® Laser System,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation
distance:
Conducted RF 3 Veff 3V d = 1,17 * SQRT(P/W)

acc. to IEC 61000-4-6 150 kHz to 80 MHz
Radiated disturbances 3 V/m 10 V/m d = 0,35 * SQRT (P/W) for 80 MHz

to 800 MHz
acc. to IEC 61000-4-3 80 MHz to 2.5 GHz
Appendix 87
Immunity test IEC 60601-test level Compliance level Electromagnetic

environment–guidance
d = 0,7 * SQRT (P/W) for 800 MHz

to 2,5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).Field
strength from fixed RF
transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance level
in each frequency range.
Interference may occur in the
vicinity of equipment marked with
the symbol "non-ionizing
radiation".
Note: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
Note: This guideline may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strength from fixed transmitters, such as base stations for radio (Cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the ophthalmologic laser
system “ Navilas®” is used exceeds the applicable RF compliance level above, additional measures may be
necessary, such as reorientation or relocating the ophthalmologic laser system “ Navilas®”. In case unusual
performance is witnessed additional measures may be required such as change of orientation or location
of the ophthalmologic laser system “ Navilas®”.
Recommended separation distances between portable and mobile RF communications equipment

and the Navilas® Laser System
The Navilas® Laser System is intended for use in an electromagnetic environment in which the radiated RF
disturbances are controlled. The operator of the Navilas® Laser System can help prevent electromagnetic
interference by maintaining a minimal distance between portable and mobile RF communications equipment
(transmitters) and the Navilas® Laser System as recommended below, according to the maximum output
power of the communications equipment.
Separation distance according to frequency of transmitter in m
Rated maximum output 80 MHz to 800 MHz 800 MHz to 2,5 GHz 150 KHz to 80 MHz
power of transmitter P in d=0,35 * SQRT(P/W) d=0,7 * SQRT(P/W) d=1,17 * SQRT(P/W)

W
0,01 0,04 0,07 0,12
0,1 0,11 0,22 0,37
1 0,35 0,70 1,17
10 1,11 2,21 3,70
100 3,50 7,00 11,70
88 Appendix
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
Note: This guideline may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
A.2 Compatible Accessories

‣ Printer — Use only the HP Officejet Pro 8100 ePrinter. This printer is required because
the Navilas® Laser System software uses a pre-installed HP driver specific to this
this printer. The installation must be performed by an OD-OS–certified service
technician.
‣ Navilas Zero Power Contact Lens - for use with the standard optical element for
conventional navigated treatment.
‣ Navilas Rapid PRP Contact Lens - for use with the peripheral optical element for
conventional navigated treatment in a wide field image.
‣ Three and four mirror contact lens - for use with the anterior optical element for
treatment of the anterior segment of the eye.
‣ TKG-104-TOUCH-IP68-GREY keyboard or alternative keyboards certified according
to IEC 60601-1 or IEC 60950-1.
‣ USB ports and Ethernet connection may be used for PPU Access Key, Memory Sticks
and service purposes only.
Warning: Do not use any computer, component, accessory, or software other than the compatible
devices listed in this operator manual. Doing so may damage the laser system and/or cause serious
injury to the patient or operating room personnel.
Warning: Use of a contact lens other than the OD-OS approved, zero power contact treatment lens
inhibits the view of the patient’s retina and is prohibited. Doing so endangers the patient and operator,
possibly causing eye damage.
Note: For treatments of anterior segments of the eye, OD-OS recommends the use of a three mirror
or a four mirror contact lens as listed above in Compatible Accessories on page 88.
Warning: No combinations between Navilas® Laser System and other systems are allowed.
A.3 Suggested Reading

Further information on retinal photocoagulation and on the indications for fundus
photography and angiography may be found in the following publications:
Appendix 89
Laser Surgery of the Posterior Segment (Second Edition up). Steven M.Bloom, Alexander
J. Bruckener : Lippincott-Raven, 1997.
Safety with Lasers and Other Sources–A Comprehensive Handbook. Sliney, D. and
Wolbarsht, M. : Plenum Press, New York, 1980.
Ophthalmic Lasers : Current Clinical Uses. March, W. F. : Slack, Inc., Thorofare, New
Jersey, 1984.
Ophthalmic Lasers (3rd ed.) L'Esperance, F. A. Jr., : C.V. Mosby Company, St.Louis
Missouri, 1989.
Current Therapy in Ophthalmic Surgery (Eds : Spaeth G, Katz L. J and Parker K. W.).
: B.C. Decker Inc, Burlington, Ontario and Philadelphia, PA: 167-170, 1989.
Spectral transmittance of intraocular lenses and damage from intense light sources.
Mainster, M. A. : J. Opht. Soc. Am. 60 : 848-855, 1970 and American J. Ophthalmol
85 :167-170, 1978.
Clinical studies on high and low power laser radiation upon some structures of the
anterior and posterior segments of the eye. Ophthalmol. 5 (1) :15-32, 1982.
Fankhauser, F., Lörtscher, H. P. and van der Zypen, E. : Int. Ophthalmol. 5 (1) :15-32,
1982.
Sicherheitsprobleme für die Augen beim Umgang mit Laserstrahlen (Safety Problems
for the eye in connection with laser radiation) Lörtscher, H. P. and Fankhauser, F. :
Klin. Mbl.–Augenheilk. 180:360-362, 1982
A.4 Acronyms and Abbreviations

Acronym Meaning Description
EMC Electromagnetic Compatibility
CW Continuous Wave Continuously emitting laser
DPSS Diode Pumped frequency-doubled Type of laser

Solid State
FA Fluorescein Angiography Imaging modality of the retina
FDA Food and Drug Administration Regulatory approval agency in US
IR Infrared Light illumination in infrared wavebands for

comfortable monochromatic imaging of the retina
KTP Potassium Titanyl Phosphate Part of the laser
MPE Maximum Permissible Exposure Parameter for description of laser and laser safety
Nd:YVO Type of laser
NHZ Nominal Hazard Zone Parameter for description of laser and laser safety
NOHD Nominal Ocular Hazard Distance Parameter for description of laser and laser safety
OD Optical Density Parameter for description of laser and laser safety
OD / OS Oculus Dexter / Sinister Right eye / left eye
PRP Pan Retinal Photocoagulation Method for treatment of the retina with a laser
90 Appendix
Acronym Meaning Description
RPE Retinal Pigment Epithel Layer within the retina
SLO Scanning Laser Ophthalmoscope Special technology for imaging the retina
USB Universal Serial Bus Connection type of external storage device
VIS Visible Stands for visible light wavebands and is used for
creating color images
Contact
Company:
Name:
Phone:
Email:
In case of doubt whom to contact, please feel free to contact the Navilas® help desk
at the Navilas® manufacturer:
OD-OS GmbH
Warthestrasse 21
14513 Teltow
Germany
+49 3328 31282 100
[email protected]
www.od-os.com
OD-OS Inc.
6201 Oak Canyon Drive, Suite 200
Irvine, CA 92618
USA
July 2014; Document Version: 2.21
Article number: 102053 Operator Manual English

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NAVILAS® Operator Manual

Preface: About this Operator Manual.........................7

Chapter 1: Introducing Navilas®................................9

Chapter 2: Safety & Regulatory Information............19

Chapter 4: The Navilas® Workflow...........................35

Chapter 5: User Interface Reference........................63

Chapter 6: Maintenance & Administration................71

About this Operator Manual

Description of Device Variants

Symbols used in this Document

‣ Intended Use & Indications

1.1 Intended Use & Indications

1.2 Contraindications, Warnings & Precautions

‣ Only appropriate tissue targets should be treated.

1.2.4 Imaging Contrast Medium—Contraindications, Warnings

1.3 Image – Plan – Treat

1.3.1 The Navilas® Imaging Principle

1.3.2 Treatment Laser

1.3.3 Treatment Modes

1.3.4 Navigation Functions

1.4 Navilas® Laser System User Interface Overview

1.4.1 Navilas® Laser System Components

Figure 1: Navilas® Laser System

The Navilas® Laser System includes the following components:

fixation target mounted on the headrest. Alternatively, different sections of the

‣ Touch-sensitive digital display: The Navilas® Laser System is controlled primarily

1.4.2 The Navilas® Laser System Controls

1. Table elevation buttons; 2. Key switch; 3. Emergency laser off

Figure 2: Controls of table and electronics housing

1. Image acquisition; 2. Illumination control; 3. Imaging mode selection; 4. Base brake

Figure 3: Device head (operator-facing side)

1. Toggle button; 2. Two push buttons (left/right); 3. Trackball; 4. Scroll wheel

Figure 4: Joystick controls

1. Power down; 2. Power up; 3. Laser energy release

Figure 5: Foot switch

1.4.3 Navilas® Laser System Software Overview

Figure 6: Navilas® Software overview

The control screen is divided into the following areas:.

Table 1: Classification information

Directive 93/42 EEC, Annex IX Medical Device Class IIb

US FDA Medical Device Classification Class II

US FDA Product Codes HLI, MYC, HQF

IEC 60601-1 Electrical Protection Class I, Type B

Canadian Medical Device Classification Class 3

Mexican Medical Device Classification Class II

US FDA CDRH laser classification Class IV

Type Diode-pumped solid state, frequency-doubled Nd:YVO

Power Output 50mW to 2W

Principal Wavelength 532nm or 577nm nominal

US FDA CDRH laser classification Class II

European EN 60825 laser classification Class 2

Type Diode, modulated

Power Output < 1 mW average output

Principal Wavelength 635 nm nominal

2.2 Regulatory Compliance and Standards

Table 2: Compliance information

Regulatory and Technical

EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic

EN 60601-2-22 Medical Electrical Equipment - Part 2-22: Particular requirements for