Zeiss i.Profiler plus User manual

i.Profiler ®plus
User manual

000000-1520-928_GA_EN_021013
User manual
i.Profiler ® plus
000000-1520-928_GA_EN_021013
10/2/2013
© 2013, Carl Zeiss Vision
All rights reserved in the event of granting of patents or registration as a utility
patent.
All names of companies and products mentioned in this manual may be
trademarked or registered trademarks. Third party products are cited for information
purposes only. This does not represent approval or recommendation of these
products.
Carl Zeiss Vision accepts no liability for the performance or use of such products.
i.Profiler ® plus is a registered trademark of the Carl Zeiss Group.
Microsoft Windows®is a registered trademark of Microsoft Corporation, Inc.
Other brand names, software and hardware names used in this user manual are
generally subject to trademark or patent protection. Naming other products only
serves information purposes and does not constitute a trademark infringement.
This user manual is protected by copyright. Unless expressly authorized in writing,
dissemination, duplication, or other commercial exploitation of this document or
communication of its contents or parts of it is not permitted. Persons in
contravention of this copyright may be liable to pay compensation for damages.
Specifications due to technical developments are subject to change. This manual is
not subject to the revision service. Please contact the manufacturer or authorized
dealer for the status of the latest edition.

Contents
000000-1520-928_GA_EN_021013
1
Contents
Contents.....................................................................................1
Notes on the user manual ..........................................................3
Purpose and availability of documentation ....................................................3
Questions and comments................................................................................ 3
Explanation of symbols used ..........................................................................4
Package check list......................................................................5
Country-specific information and labels.....................................6
Classification/Manufacturer's declaration ......................................................6
Intended use ...................................................................................................6
Specified purpose ........................................................................................... 7
User profile I: Measurement with the i.Profiler ® plus ....................................................7
User profile II: Analysis of measurement data.............................................................8
Disposal of the product ..................................................................................9
Labels............................................................................................................10
Performance specifications ......................................................12
Functional description...................................................................................12
Wavefront measurement ..........................................................................................12
Topography measurement........................................................................................14
Service life.....................................................................................................16
Description of the device..........................................................17
Installation ...............................................................................19
Installation ....................................................................................................21
Electrical connection .....................................................................................22
Calibration touch screen ...............................................................................23
Connection of an external monitor...............................................................23
Integrating the i.Profiler ® plus into an existing network via DHCP ................24
Integrating the i.Profiler ® plus into an existing local network........................25
Printer installation for the i.Profiler ® plus .......................................................26
Connecting the printer to the i.Profiler ® plus directly (peer-to-peer)...........................27
Connecting the printer via an existing network........................................................28
Configuration of a network memory device .................................................29
Requirements made on the NAS device....................................................................30
Recommendations for the NAS device .....................................................................30
Installation of the NAS device...................................................................................31

Contents
000000-1520-928_GA_EN_021013
2
Installation of the Atlas Review Software connection ................................. 34
Connecting the PC with the Atlas Review Software directly to the i.Profiler ® plus
(peer to peer) ............................................................................................................34
Connect Atlas Review Software via an existing network with i.Profiler ® plus .............36
Daily use .................................................................................. 38
Switching on ................................................................................................ 39
Operation................................................................................. 40
User's safety obligations .............................................................................. 40
Work sequence............................................................................................. 41
Explaining the i.Profiler ® plus measurement procedure to the patient ......... 42
Positioning the patient for measurements................................................... 44
Shutting down ......................................................................... 45
Switching off the device............................................................................... 45
Maintenance and care ............................................................. 47
Fault remedy ................................................................................................ 47
Problems with the electric system.............................................................................47
Monitor problems.....................................................................................................48
Problems with the internal printer ............................................................................48
Problems with the flexible optical measuring head...................................................48
Measurement problems............................................................................................49
Replacing the fuses ...................................................................................... 51
Maintenance................................................................................................. 52
Replacing the print paper roll ...................................................................................52
Care and cleaning .....................................................................................................52
Technical data...........................................................................................................54
Electromagnetic compatibility ................................................. 56
Abbreviations/Glossary ............................................................ 60
Figures ..................................................................................... 61
Index........................................................................................ 62

Notes on the user manual
000000-1520-928_GA_EN_021013
3
Notes on the user manual
Purpose and availability of documentation
This user manual and the software description of this device explain the
safety precautions, functions, usage, performance parameters, and measures
for care and maintenance of the i.Profiler ® plus.
Correct operation of the system is imperative for its safe and successful
function. You should therefore ensure that you are thoroughly familiar with
this user manual before using the i.Profiler ® plus the first time.
The user manuals and other documentation enclosed with the i.Profiler ® plus
should be kept accessible to users at all times to ensure that the information
required for use of the i.Profiler ® plus is readily available.
Questions and comments
If you have any questions or comments concerning this user manual or the
i.Profiler ® plus, please contact Carl Zeiss Customer Support.

Notes on the user manual
000000-1520-928_GA_EN_021013
4
Explanation of symbols used
The symbols used in this user manual refer to important safety information.
They warn against possible health risks or fatal danger and contain useful
notes. Whenever you see these symbols, please read the respective
information carefully and observe all safety notes and information
appropriately marked in the user manual and on equipment labels.
WARNING
Indicates a hazardous situation which may result in fatal or serious bodily
injury if the appropriate safety precautions are not heeded.
CAUTION
Indicates a hazardous situation which may result in minor injury if the
appropriate safety precautions are not heeded.
CAUTION - PROPERTY DAMAGE
Indicates possible device damage if the respective safety precautions are not
heeded.

Information, hints, and advice for a better understanding of the
instructions to be observed in the operation of the device.

Package check list
000000-1520-928_GA_EN_021013
5
Package check list
WARNING - GENERAL HAZARDS
Only accessories, including software, conforming to the requirements stated
in this user manual may be used.
The device is delivered with the following components:
•Power cable
•Paper for chin rest
•Printing paper roll
•Stylus (pointer) for use with touch screen
•Test eye pair
•Dust cover
A complete up-to-date list of accessories can be obtained from your dealer.

Country-specific information and labels
000000-1520-928_GA_EN_021013
6
Country-specific information and
labels
Classification/Manufacturer's declaration
WARNING - GENERAL HAZARDS
This device may only be set up, operated, and used for the specified
purpose and according to national regulations and occupational safety and
accident prevention regulations. Further notes on classification are to be
found in section Technical data.
The device complies with EC Directive 93/42/MDD concerning medical
devices.
Device class according
to MDD: IIa
Laser class: Class 1 (EN 60825-1:2003)
EMC: See chapter Electromagnetic compatibility,
page 56 and following.
UMDNS No.: 13-313
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
Intended use
The i.Profiler ® plus is a diagnostic device for the measurement and analysis of
imaging errors in the human eye.
0297

Country-specific information and labels
000000-1520-928_GA_EN_021013
7
Specified purpose
CAUTION - RISK OF OPERATING ERRORS
This device may only be installed, operated, used, and maintained by
persons who have been properly trained or who have the required
knowledge and experience to do so. Please adhere to the additional
national qualification guidelines applicable in your country.
The following user profiles must be considered.
User profile I: Measurement with the i.Profiler ® plus
The user should have experience in the following areas:
•Procedures and handling of customers/patients in the healthcare sector
•Standard anamnesis and screening procedures in ophthalmology and/or
optometry
•Standard patient instructions during a measuring procedure on the
human eye for optimization of measurement quality
•Standard acoustic and optical warning signals/displays on medical devices
during a measuring procedure on the human eye
•Standard device interfaces (USB, Ethernet, VGA)
•Familiarity with the Microsoft Windows operating system and
applications based on it
•Standard maintenance, cleaning and calibration procedures on medical
devices
User profile IA: Assistant optician/optometrist
The user (e.g. trainee, salesperson) should have the experience described
under user profile I plus the following skills:
•Handling of standard test records and measurement results in optics/
optometry such as refraction values (sphere, cylinder, axis), higher-order
aberrations (Zernike polynomials), ophthalmometer readings (corneal
radii) and corneal topography data (axial, local and height representation,
etc.)
•Evaluation of the quality of readings with the aid of evaluation criteria for
measurement quality in the user manual

Country-specific information and labels
000000-1520-928_GA_EN_021013
8
User profile IB: Assistant in clinic/practice
In addition to the experience described in user profiles I and IA, the user
(e.g., doctor's assistant, nurse) should have knowledge of pathological
factors which influence measurement quality, as listed below:
•Cataract-related light scattering of optical media
•Corneal opacity-related light scattering of optical media
•Optimization of device settings (e.g. cataract modes) with the aid of the
user manual, to minimize pathological factors that influence
measurement quality
User profile II: Analysis of measurement data
The user (e.g. BSc, certified engineer, master, cataract surgeon, refractive
surgeon, ophthalmologist) should have the experience described under user
profiles I, IA and IB. In addition, he/she should have a sound knowledge of:
•Accuracy, interpretation and possible sources of error of measurement
data based on Placido disc and Hartmann-Shack technology
•Diagnosis of measurement data based on medical devices
•Standard ophthalmological/optometrical measuring records and readings,
as well as their interpretation, resulting diagnoses, prescription of visual
aids or therapeutic treatment, etc.
•Corneal pathologies associated with corneal topography
•The applied therapy method in the interpretation of readings for therapy
planning and implementation
•Consequences of incorrect or inaccurate readings and careful validation
of readings (quality evaluation, multiple readings, test of consistency with
other diagnostic results)

Country-specific information and labels
000000-1520-928_GA_EN_021013
9
Disposal of the product
CAUTION - RISK OF ENVIRONMENTAL POLLUTION
Packaging materials should be retained for future relocation or repair.
If you wish to dispose of the packaging material, hand it over to a
recognized collection system for recycling.
The device contains electronic components. At the end of its lifetime, the
device and its integrated batteries should be disposed of in accordance with
the relevant national regulations.
Disposal of the product within the EU
In accordance with applicable EU guidelines and national regulations at the
time at which the product was brought onto the market, the product
specified on the consignment note is not to be disposed of via the domestic
waste disposal system or communal waste disposal facilities.
For further information on disposal of this product, please contact your local
dealer, the manufacturer or its legal successor company.
Where the product or its components are resold, the seller must inform the
buyer that the product must be disposed of in accordance with the currently
applicable national regulations.

Country-specific information and labels
000000-1520-928_GA_EN_021013
10
Labels
Fig. 1 Type plate on the i.Profiler ® plus

Country-specific information and labels
000000-1520-928_GA_EN_021013
11
1
Type plate of i.Profiler ® plus
Application part
type B
EU conformity mark
Fuse
P/N
Catalog number/
part number
S/N
Serial number
Crossed waste bin, see
chapter "Disposal of
the product"
Date of manufacturing
Consult user manual

Performance specifications
000000-1520-928_GA_EN_021013
12
Performance specifications
Functional description
The i.Profiler ® plus offers two basic measuring options:
•Precision wavefront measurement with Hartmann-Shack technology
•Placido disc corneal topography with central and peripheral keratometry
Wavefront measurement
1 Eye
2 Beam splitter
3 Micro-lens array
4
Camera
Fig. 2 Measuring principle of the Hartmann-Shack sensor

Performance specifications
000000-1520-928_GA_EN_021013
13
The wavefront aberration measurement is based on Hartmann-Shack sensor
technology. The mode of functioning is shown in Fig. 2 in a simplified form.
An infrared laser beam generates a light spot on the retina of the eye. The
light pencil reflected from this light spot traverses the optical system from
the point of the retina to exit the eye at the corneal plane, where it
generates the wavefront (reversed ophthalmological principle). Information
on all individual optical defects of the eye (lower and higher order
aberrations) is collected here. To guarantee correct measurement, the
patient fixates on the test mark (in the form of a hot air balloon). This
ensures that the light spot of the measuring laser accurately strikes the fovea
centralis, the point of sharpest vision.
The wavefront emerging from the pupil of the eye strikes the Hartmann-
Shack sensor, consisting of a regular micro-lens array and a video (CCD)
camera. Each micro-lens of the array creates a light spot on the camera chip,
forming a pattern of light spots (Fig. 3). The position of the light spots is
evaluated with the aid of software algorithms. An eye without imaging
errors (optically perfect) adjusted to long range generates an even wavefront
that is displayed on the camera in the form of a completely regular light spot
array. An eye with imaging errors (not optically perfect) generates an
uneven, distorted wavefront, resulting in tilting of the individual light spots
on the camera chip. The wavefront or refraction of the eye within the pupil
opening is calculated from the analysis of these tilts. The results of
measurement are shown in the form of a two-dimensional, color-coded
wavefront map whose diameter corresponds to the measured diameter of
the pupil and describes the optical properties of the eye. In addition, the
optical aberrations of the eye are mathematically characterized and
quantified by Zernike coefficients.
A
B
Fig. 3 Image of light spots on the camera chip (A) and image of the reconstructed
wavefront map (B) over the total exit pupil.

Performance specifications
000000-1520-928_GA_EN_021013
14
The wavefront map is uniformly colored for an eye with normal vision
(emmetropic). If the eye exhibits refractive errors, these will be shown color-
coded in the wavefront map: Short-sightedness (myopia) and farsightedness
(hyperopia) manifest themselves in wavefront maps that have spherical caps
curved to the inside or outside. Astigmatism appears in the form of elliptical
contours (areas of the same color) in the wavefront map with the elliptical
axis along the astigmatism axis. Other abnormalities (higher order
aberrations) result in characteristic irregular structures in the wavefront map.
A wavefront measurement is only a snapshot of the optical state of the
patient's eye. It is not a fixed parameter for the eye and depends on the
accommodation state.
Topography measurement
The topography of the cornea is measured with a Placido disc. The diagram
(Fig. 4) demonstrates the optical imaging in simplified form.
1
Camera
2 Lens
3 Eye
4 Placido disc with illuminated rings
Fig. 4 Imaging beam path of a topography measuring device with a Placido disc.
A light pencil originating at point P is reflected by the mirroring, convex surface of
the cornea. The virtual point P' is reproduced via a lens to the camera P''.

Performance specifications
000000-1520-928_GA_EN_021013
15
The Placido disc has ring-shaped, diffusely transparent apertures which
guarantee even projection of the rings on the eye. The eye positioned in
front of the Placido disc reflects the ring image of the Placido disc like a
convex mirror. The reflections of the surface of the cornea of the eye are
captured by a video (CCD) camera located behind the Placido disc.
The position of the rings on the cornea change depending on the form of
the corneal surface. An evenly curved surface of the cornea exhibits
concentric and undeformed rings (A, Fig. 5). However, their width and
spacing differs subject to the radius of curvature of the cornea: The smaller
the radius of curvature of the cornea, the narrower the rings and the closer
they are together. The flatter the cornea, the wider the rings and the farther
apart they are. If the corneal surface deviates from the shape of a sphere,
the shape of the rings will also change (B, Fig. 5).
Software algorithms evaluate the form and position of the rings, providing
detailed information on the shape of the corneal surface. The distance of the
rings from one another is a measure of the radius of curvature of the corneal
surface, the deviation from a circle indicates the extent of the astigmatism.
The evaluated data is displayed in different two-dimensional, color-coded
charts which illustrate the different characteristics (optical effects, local
curvature) of the cornea.
Fig. 5 The image of the rings of the Placido disc on the camera for a normal cornea (A)
and a distorted cornea (B).

Performance specifications
000000-1520-928_GA_EN_021013
16
Service life
WARNING - GENERAL HAZARDS
The development, production and maintenance of this device, together
with associated risks, are based on an expected useful life of eight years.
Only specialist personnel trained by the manufacturer may make
modifications to the product.
Unauthorized changes will void the warranty.
Changes to the product or failure to follow the manufacturer’s instructions
may substantially reduce the expected service life and significantly increase
the risk associated with use of this device.

Description of the device
000000-1520-928_GA_EN_021013
17
Description of the device
1 Optical measuring head
2 LCD touch screen (swivel-mounted)
3 On/Off button
4 Stylus (pointer)
Fig. 6 i.Profiler ® plus, view from the operator side
Fig. 6 and Fig. 7 show the i.Profiler ® plus from the operator and patient side.
The measuring head is inclined for functional reasons; this is not a defect.

Description of the device
000000-1520-928_GA_EN_021013
18
1 Device base with computer and electronics
2
Motorized chin rest
3 Two-button control of chin rest on both sides
4 Exit aperture of measuring optics
5 Forehead rest
Fig. 7 i.Profiler ® plus, view from the patient side