Zeiss i.Profiler plus User manual

i.Profiler plus
Instructions for use – Part 1
Version 1.5

EN 20_070_0009I v1.5
Instructions for use – Part 1
i.Profiler plus
EN 20_070_0009I v1.5
2021/03/05
© 2021, Carl Zeiss Vision GmbH
Third-party products mentioned in this document are included for information
purposes only and Carl Zeiss Vision does not endorse or recommend these
products, unless explicitly stated otherwise.
Carl Zeiss Vision assumes no liability for the performance or use of these
products.
TRADEMARK is a trademark or registered trademark of LEGAL ENTITY
TRADEMARK OWNER.THIRD PARTY TRADEMARK is a trademark or registered
trademark of THIRD PARTY LEGAL ENTITY TRADEMARK OWNER. All other
trademarks, software and hardware names used in this Instructions for use may
be subject to trademark or copyright protection and are the property of their
respective owners.
This document is protected by copyright. If not expressly approved in writing,
the transmission, duplication, or other use or disclosure of their content -
including in excerpted form - is prohibited. Violations may result in claims for
damages. Carl Zeiss Vision reserves the right to make changes due to further
technical developments. These Instructions for use are not regularly updated.
Please contact the manufacturer or your responsible dealer for the newest
edition.

EN 20_070_0009I v1.
5
1
Contents
Contents...................................................................................................................................3
Information on this Instructions for use – Part 1.........................................................................5
Purpose and availability of documentation .............................................................................5
Explanation of symbols..........................................................................................................6
Scope of delivery.......................................................................................................................5
Country-specific information and exterior labeling......................................................................6
Manufacturer classification/declaration ..................................................................................6
Intended use .........................................................................................................................6
Normal Use / Indication .........................................................................................................6
Proper use.............................................................................................................................7
Target Customers ..................................................................................................................7
User profile I: Measurements with the i.Profiler plus .................................................................7
User profile II: Analysis of measured data...............................................................................9
Disposing of the product .....................................................................................................10
Exterior labeling ..................................................................................................................11
Performance specification........................................................................................................14
Functional description .........................................................................................................14
Wavefront measurement .....................................................................................................14
Topography measurement...................................................................................................16
Service life...........................................................................................................................18
Device description ...................................................................................................................19
Installation ..............................................................................................................................21
Set-up.................................................................................................................................23
Electrical installation............................................................................................................24
Touch screen calibration......................................................................................................25
Connecting an external monitor ..........................................................................................25
Connecting the i.Profiler plus to an existing network with DHCP.............................................26
Connecting the i.Profiler plus to an existing local network ......................................................27
Printer installation for the i.Profiler plus ..................................................................................28
Connect printer directly to the i.Profiler plus (peer to peer) .....................................................29
Connect printer via an existing network ...............................................................................30
Configuring a network attached storage device ...................................................................31
Requirements for the NAS device.........................................................................................32
Recommendations for the NAS device .................................................................................32
Installing the NAS device .....................................................................................................33
Daily commissioning............................................................................................................36
Switch on............................................................................................................................37
Device operation .....................................................................................................................38
Safety obligations of the user ..............................................................................................38
Explaining measurements with the i.Profiler plus to customers................................................39
Positioning the customer for the measurement ....................................................................41
Decommissioning....................................................................................................................42
Switching off the device ......................................................................................................42
Maintenance...........................................................................................................................44
Troubleshooting..................................................................................................................44
Electrical problems ..............................................................................................................44
Screen problems..................................................................................................................45

EN 20_070_0009I v1.5
2
Problems with the internal printer........................................................................................45
Problems with movable optical measuring head...................................................................45
Warnings regarding measurement quality ............................................................................45
Warnings due to wrong operator entry................................................................................46
Other Warnings due to hardware or software failure ...........................................................46
Safety Warnings regarding unwanted behavior ....................................................................46
Measurement problems.......................................................................................................47
Exchanging fuses.................................................................................................................49
Maintenance.......................................................................................................................50
Exchanging the printer paper role........................................................................................50
Care and cleaning ...............................................................................................................50
Technical data.........................................................................................................................52
Electromagnetic compatibility..................................................................................................54
Environment of intended uses: Home Healthcare Environment .............................................55
Abbreviations/Glossary ............................................................................................................60
Figures....................................................................................................................................61
List of keywords ......................................................................................................................62

EN 20_070_0009I v1.
5
Information on this Instructions for use – Part 1
3
Information on this Instructions for use – Part 1
Purpose and availability of documentation
This Instruction for use - Part 1 and the associated Instruction for use - Part 2
explain the safety measures, function, use, performance parameters, care and
maintenance measures required for the i.Profiler plus. Thereby the Instruction for use
- Part 1 describes the Hardware (Material Numbers 2358-727 & 1005-825), while
the Instruction for use - Part 2 describes the Software of the device.
Correct handling of the system is essential to ensuring safe and successful
operation. Before commissioning and using the i.Profiler plus, please read both
Instructions for use carefully and familiarize yourself thoroughly with their contents.
Both Instructions for use and other documentation delivered with the
i.Profiler plus must be stored so that information required to use the i.Profiler plus is
available to users at all times.
The wiring diagram is only available from the manufacturer. In addition, all repairs
and modifications must be carried out by the manufacturer.

EN 20_070_0009I v1.5
4 Information on this Instructions for use – Part 1
Explanation of symbols
The symbols used in these Instructions for use – Part 1 notify you of
important safety information and may include warnings of potential health
hazards or death or may provide useful tips. When you see these symbols,
please read the provided information carefully and observe the safety
notices and information specifically designated in these Instructions for use
– Part 1 and on the device.
Information, tips and notifications for better understanding
process instructions during device operation.
WARNING
Indicates a hazardous situation which could result in death or serious
injury if appropriate safety measures are not taken.
CAUTION
Indicates a hazardous situation which could result in slight injury if
appropriate safety measures are not taken.
CAUTION
Unplug the power plug before completing any work on the device!
CAUTION - PROPERTY DAMAGE
Indicates the potential that property damage may occur if appropriate
precautionary measures are not taken.


EN 20_070_0009I v1.
5
Scope of delivery 5
Scope of delivery
The device is delivered with the following components:
• Power cable
• Paper for the chin rest
• Printer paper roll
• Stylus for use on the touch screen
• Test eye device
• Dust protection cover
A current, complete list of accessories is available from Carl Zeiss Vision
GmbH and authorized service partners.
WARNING - GENERAL HAZARD
Only accessories and software may be used that conform to the
requirements described in this instruction manual.

EN 20_070_0009I v1.5
6 Country-specific information and exterior labeling
Country-specific information and exterior
labeling
Manufacturer classification/declaration
This device fulfills the Medical Devices Directive 93/42/MDD.
Device class under MDD: IIa
Laser class: Class 1 in accordance with DIN EN 60825-
1:2007
EMC:
GMDN Code:
UMDNS Classification:
See chapter Electromagnetic compatibility,
Page 52 et seqq.
36386
13-313
This declaration will be rendered null and void if modifications are made to
the product that were not authorized by the manufacturer.
The product is RoHS-compliant under Directive 2011/65/EU.
Intended use
The i.Profiler plus is a diagnostic device for the measurement and analysis of
imaging errors in the human eye.
Normal Use / Indication
The i.Profiler plus can be used on humans to measure and analyse the
imaging errors of the human eyes. The patient shall be awake and
collaborative during measurement, as he/she shall be able to follow the
instructions from the operator.
WARNING - GENERAL HAZARD
This device may only be set up, operated and used according to its
intended purpose and in accordance with country-specific provisions,
occupational protection and accident prevention regulations. Further
information on classification is provided in the section Technical data.

EN 20_070_0009I v1.
5
Country-specific information and exterior labeling
7
Proper use
Target Customers
All applications combined incorporate the following categories within
general ophthalmology and optometry practice. The different users are
categorized in groups of “perform measurement only” or “measurement
and analysis/interpretation”. Each user group within the “measurement
and analysis/interpretation” category is expected to perform analyses and
interpretations of data in the areas added in brackets.
Performing measurement procedure and analysis/interpretation of data:
Optometrists / General Ophthalmologists (Custom spectacles,
Screening, custom CL)
Ophthalmic opticians - craftsman, bachelor (Custom spectacles,
custom CL)
Performing measurement procedure only:
Clinic technicians
Ophthalmic opticians (assistant, apprentice)
The following user profiles must be considered:
User profile I: Measurements 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
CAUTION - HAZARD DUE TO INCORRECT OPERATION
The device may only be installed, operated, used and maintained by
persons with the necessary training or knowledge and experience.
Please also observe the national qualification guidelines applicable in
your country.

EN 20_070_0009I v1.5
8
Country-specific information and exterior labeling
User profile IA: Optometry/ophthalmology assistant
The user (e.g. trainee, salesperson) should have the experience described
under user i.Profiler 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

EN 20_070_0009I v1.
5
Country-specific information and exterior labeling
9
User profile IB: Clinical/practice assistant
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 measured data
The user (e.g. BSc, certified engineer, master, general ophthalmologist)
should have the experience described under user profiles I, IA and 1B. 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)
A typical patient work flow scenario within an optometry or general
ophthalmology practice in the USA could be that a technician or assistant is
taking measurements with the i.Profiler plus in the pre-exam room as a starting
point for the subjective refraction.
Within a networked practice the auto-retractor values may be transferred
automatically to an electronic phoropter head while the raw data would be
transferred automatically to a review software running on a PC in the exam
room. Following the subjective refraction and other eye examinations the
OD/MD would review the wavefront data to discuss the planned or
recommended application with the patient. Once a decision is made, either
the technician would execute an order via the practice PMS system or straight
through the review software (e.g. i.Scription lens order) or the doctor would
save and print a report for manual ordering.

EN 20_070_0009I v1.5
10
Country-specific information and exterior labeling
Disposing of the product
Disposal of the product within the EU
The product specified on the delivery note must not be disposed of with
household waste or municipal waste disposal companies in accordance with
EU directives and national regulations in force at the time of placing it on the
market.
For further information on disposing of the product, please contact your
local dealer or the manufacturer or their legal successor.
Upon resale of the product or its components, the seller must notify the
buyer that the product must be disposed of in accordance with the currently
applicable national regulations.
CAUTION - ENVIRONMENTAL CONTAMINATION HAZARD
The packaging material should be stored in case of relocation or repair.
If you want to dispose of the packaging material, recycle it via a
recognized collection system.
The device contains electronic components. At the end of its service life,
the device and installed batteries must be properly disposed of
according to national law.

EN 20_070_0009I v1.
5
Country-specific information and exterior labeling
11
Exterior labeling
1
i.Profiler plus type plate
2
Notification sign & Date of manufacture
Fig. 1: Type plate on i.Profiler plus

EN 20_070_0009I v1.5
12
Country-specific information and exterior labeling
Labelling refers to Material Number (REF): 2358-727
1
i.Profiler plus type plate
Type B applied
part
EU conformity slip
with ID number for
the notified body
Manufacturer
Fuse
Date of
manufacture
~Alternating
current
Catalog
number/part
number
Serial number
Disposal
notification for the
EU
TÜV Rheinland
permit for the USA
and Canada
Medical Device
Unique device
identifier
Data Matrix Code
according to GS1
2
Notification sign
“Observe the
Instructions for use”

EN 20_070_0009I v1.
5
Country-specific information and exterior labeling
13
Labelling refers to Material Number (REF): 1005-825
1
i.Profiler plus type plate
Type B
applied part
EU conformity
slip with ID
number for the
notified body
Manufacturer
Fuse
~Alternating
current
Catalog
number/part
number
Serial number
Disposal
notification for
the EU
TÜV Rheinland
permit for the
USA and
Canada
2
Date of manufacture sign
Date of
manufacture
Date of
manufacture
(YYYY/MM)
Notification sign
“Observe the
Instructions for use”

14 Performance specification
EN 20_070_0009I v1.5
Performance specification
Functional description
The i.Profiler plus offers two basic measurement options:
• Precision wavefront measurement with Shack-Hartmann technology
• Placido disc-based corneal topography with central and peripheral
keratometry
Wavefront measurement
1 Eye
2 Beam splitter
3 Microlens array
4 Camera
Fig. 2: Measurement principle for the Shack-Hartmann sensor

EN 20_070_0009I v1.
5
Performance specification 15
Measurement of wavefront aberrations is based on the technology of a
Shack-Hartmann sensor. Its function is illustrated in a simplified manner in
Fig. 2. An infrared laser beam creates a point of light on the retina of the
eye. The light beam reflected from this point of light passes through the
optical system from the retina until it exits from the eye in the corneal plane,
creating the wavefront there (reverse ophthalmological principle).
Information on the individual optical errors in the eye (lower and higher
order aberrations) is gathered during this process. To ensure correct
measurement, the customer fixes their gaze on a test mark (offered in the
form of a hot air balloon). This ensures the point of light generated by the
measurement laser precisely strikes the fovea centralis, the center point
where eyesight is sharpest.
The wavefront exiting the pupil intersects with the Shack-Hartmann sensor,
which consists of a regular microlens array and video camera (CCD camera).
Each microlens in the array generates a point of light on the chip of the
camera, creating a pattern of light points (Fig. 3). The positions of the points
of light are evaluated using software algorithms. An eye focusing on a
distant point without aberrations (optically perfect) creates an even
wavefront, which is represented as a completely regular grid of light points
on the camera. An eye with aberrations (not optically perfect) creates an
uneven, distorted wavefront, which causes the individual points of light on
the chip of the camera to be shifted. Analyzing these shifts makes it possible
to calculate the wavefront or refraction of the eye within the opening of the
pupil. The results of the measurement are illustrated in the form of a two-
dimensional, color coded wavefront map with the same diameter as the
measured pupil diameter and describing the optical characteristics of the
eye. In addition, the optical aberrations of the eye are characterized and
quantified mathematically by Zernike coefficients.
Fig. 3: Image of the points of light on the chip of the camera (A) and image of the
reconstructed wavefront map (B) over the entire exit pupil
A
B

16 Performance specification
EN 20_070_0009I v1.5
The wavefront map is colored uniformly for an emmetropic eye without
aberrations. If an eye has refractive errors, these are shown as color coded
in the wavefront map. Short sightedness (myopia) and far sightedness
(hyperopia) are expressed in wavefront maps showing spherical caps curved
inward or outward. Astigmatism is represented as elliptical contour lines
(areas of the same color) on the wavefront map with the axis of the ellipses
along the axis of the astigmatism. Other abnormalities (higher order
aberrations) result in characteristic irregular structures in the wavefront
map.
A wavefront measurement is only a snapshot of the optical condition of the
customer's eye. It is not a constant picture of the eye and depends on
accommodations.
Topography measurement
The topography of the cornea is measured using a process involving a
Placido disc. The diagram (Fig. 4) provides a simplified illustration of optical
imaging.
1 Camera
2 Lens
3 Eye
4 Placido disc with illuminated rings
Fig. 4: Imaging beam path of a topographical measurement device with a Placido
disc. A light beam starting at point P is reflected by the reflective, convex
surface of the cornea. The virtual point P’ is depicted on the camera P” via a
lens.

EN 20_070_0009I v1.
5
Performance specification 17
The Placido disc has ring-shaped, diffuse transparent openings that ensure
the rings are projected evenly on the eye. The eye, positioned in front of the
Placido disc, reflects the ring pattern of the Placido disc like a convex mirror.
The reflections on the corneal surface of the eye are recorded by a video
camera (CCD camera) behind the Placido disc.
The positions of the rings on the cornea change depending on the shape of
the corneal surface. An evenly curved corneal surface shows concentric,
non-deformed rings (A, Fig. 5). However, their width and spacing changes
depending on the radius of curvature of the cornea. The smaller the radius
of curvature of the cornea, the narrower the rings are and the closer they
move together. The flatter the cornea is, the wider the rings are and the
farther they are apart. If the shape of the corneal surface differs from the
shape of a spherical surface, the shape of the rings also changes (B, Fig. 5).
Software algorithms evaluate the shape and position of the rings to obtain
more detailed information on the shape of the corneal surface. The distance
between the rings is a measurement for the radius of curvature for the
corneal surface, and the deviation from a circular shape is a measure of
astigmatism. The evaluated data is represented in different two-dimensional
color-coded maps that show 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 normalcornea
(A) and for a curved cornea (B).

18 Performance specification
EN 20_070_0009I v1.5
Service life
WARNING - GENERAL HAZARD
The development, manufacturing and maintenance of the device and
associated hazards are based on an expected service life of eight
years.
Modifications may only be made by professional technician trained by
the manufacturer.
The device may only be serviced and repaired by the manufacturer. The
device may not be repaired during use.
Unauthorized modifications will void the warranty.
Modifications to the product, or failing to observe the manufacturer's
instructions, could significantly shorten the expected service life and
greatly increase the hazards associated with using the device.