Hardware Manual IPP-DE

i.Profiler ® plus User manual

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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

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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

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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

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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.


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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

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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

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Classification/Manufacturer's declaration


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


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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


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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)


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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.


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Labels

Fig. 1 Type plate on the i.Profiler ® plus


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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

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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


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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.


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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''.


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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).


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Service life


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

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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.


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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

Installation

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Installation


The device may not be stored or operated in ambient conditions other than those prescribed (see Technical data on page 54).

The device should be set up so that the power cable can be disconnected from the power supply quickly and easily without any tools.

WARNING - RISK OF ELECTRIC SHOCK

Additional extension cables or portable multiple sockets may not be used.

The electrical installation must conform to IEC 60364-7-710 or the applicable national regulations. This includes the existence of a ground fault circuit interrupter (GFCI).

To avert the risk of an electric shock this device may only be connected to a power supply with a protective earth conductor.

Ensure that the power supply plug is suitable and certified for the local connection. If the supplied power cable must be replaced, at least the following specifications must be adhered to:

• Protective earth conductor resistance maximum 0.2 Ohm

• Local certification of the power cable for connection to medical devices

• Device plug C19 conforming to IEC 60320

• Cross-section at least 0.75 mm²/AWG 18 Hospital Grade design for specific countries (e.g. USA, Canada)(For cables > 2.5 m the cross-section must be increased to 1.5 mm²)

WARNING - FIRE HAZARD

The device is not suitable for operation in explosion risk areas (e.g. combustible mixture of anesthetic, cleaning, or disinfecting agents with air, oxygen, or nitrous oxide).

The electrical installation must conform to IEC 60364-7-710. The data concerning power consumption on the type plate must be taken into account in the selection of overcurrent protection.

Installation

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CAUTION - DANGER FROM FALLING PARTS

When selecting a suitable table, ensure that the combination of table and device is stable up to an angle of tilt of 10°. Furthermore, the table must be designed for 4 times the weight of the device configuration. If the table is on casters, these must have a locking device.


Do not store or use this device in damp rooms. Do not expose the device to water splashes, dripping or sprayed water.

• The manufacturer accepts no liability for damage caused by unauthorized

access to the interior of the device. Such actions will also render any warranty claims invalid.

• It is also important to comply with the instructions supplied with accessories.

Should it be necessary to enter data at the i.Profiler ® plus for the integration into a network or for configuration of the i.Profiler ® plus or its accessories, you can use the on-screen keyboard of the Windows Accessibility options. Alternatively, you can connect an external keyboard with a USB connection to the device.

Installation

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Installation


For a change of location the device should always be lifted by two persons using the recessed handles (1, Fig. 8) on the underside. Do not use the display as a handle. As far as possible it should be transported on a moving support fitted with brakes. Avoid impact during transport, as the device contains shock-sensitive elements. When transporting outside the premises, always use the transport packaging.

1 Recessed handles

Fig. 8 Recessed handles on the underside of the i.Profiler ® plus

• Set up the device so that no light sources (ceiling lamps, spots, etc.) are directed at the measuring zone or surrounding area (forehead rest, measuring head).

• We recommend the use of a height-adjustable instrument table. This facilitates the positioning of the patient in front of the i.Profiler ® plus for achieving good measuring results.

• We recommend a minimum table size of 420 x 600 mm for the standalone i.Profiler ® plus.

• We recommend not setting the i.Profiler ® plus on refraction units with a rigidly mounted forehead rest. Installation on refraction units without a rigidly mounted forehead rest with the corresponding minimum table size is possible.

• Position the device on a horizontal surface.

• Connect the device to the power supply with the power cable.

Installation

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Electrical connection

• Connect optional accessories, if available.

• Connect power cable.

1 LAN connections with disconnection voltage of 4 kV (2)

2 USB ports (3)

3 VGA connector for monitor

4 RS232 serial interface

5 Fuse compartment

6 Power switch ON (I)/OFF (0)

7 Socket for power cable

8 In-built printer (paper prints)

9 USB port

Fig. 9 Connection panel on the i.Profiler ® plus


If connecting external devices to the interfaces of the i.Profiler ® plus, the operator must meet the safety requirements as per IEC 60601-12005 chapter 16 (medical electrical systems)!

A USB isolator (cut-off voltage at least 4 kV) must be used for data exchanged via external USB devices with separate power supply. The USB isolator may not be powered by an external power supply.

Installation

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CAUTION - RISK OF OPERATING ERRORS

Only software authorized by Carl Zeiss may be used on this device.

The device may only be connected to networks which are protected from public networks (Internet) by firewalls conforming to the latest technical standards!

Calibration touch screen

• After the start, quit the i.Profiler ® plus software by pressing the Close Application button in the Shut Down window and switch to the Microsoft Windows desktop (administrator rights required).

• Double-click on the Touch Screen Calibration icon on the desktop.

• Click the Standard Calibration button on the Calibrate tab.

• Follow the prompts appearing on the screen.

• Confirm the calibration by clicking on OK.

• Double-click on the Save Configurations program icon on the Microsoft Windows desktop to save the new configuration. The device will restart.

Connection of an external monitor

• Connect the external monitor and the i.Profiler ® plus using a VGA cable via VGA connector for monitor (4, Fig. 9)

• Always switch on the external monitor before switching on the i.Profiler ® plus.


• Click on the symbol on the right side of the task bar.

• Select Graphics Properties… from the menu bar.

• The Intel® Graphics Media dialog appears.

• Select "Twin" or "Intel® Dual Display Clone" on Multiple Display on the Display Devices tab. Ensure that you have selected "Notebook" in the Primary Device field and "Monitor" in the Secondary Device field.

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• Confirm your selection by clicking on OK. The Confirm Desktop Change dialog appears.

• Confirm with OK.

Alternatively you can proceed as follows:

• Click on the symbol on the right side of the task bar.

• Select Graphics Properties… from the menu bar.

• Select "Intel® Dual Display Clone" and then "Notebook + Monitor" in the Output To field.


Always switch on the external monitor before switching on the i.Profiler ® plus otherwise the monitor will not be registered when booting the device.

Integrating the i.Profiler ® plus into an existing network via DHCP

• Connect the i.Profiler ® plus to the practice network (LAN) using a network cable.


• Double-click the Network Configurator symbol on the desktop. The

Network Configuration Tool dialog appears.

• Select the Ethernet connection used by your network in the Network Adapter field. The left connection is marked [00000000], the right connection [00000001].

• Select Activate DHCP.

• Click on the Change IP button. The message "Change to DHCP was successful" appears.

• Close the Network Configurator.


Installation

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Integrating the i.Profiler ® plus into an existing local network

• Connect the i.Profiler ® plus to the practice network (LAN) using a network cable.

• Switch the i.Profiler ® plus on. After the start, quit the i.Profiler ® plus software by pressing the Close Application button in the Shut Down window and switch to the Microsoft Windows desktop (administrator rights required).

• Double-click the Network Configurator symbol on the desktop. The

Network Configuration Tool dialog appears.

• Select the Ethernet connection used by your network in the Network Adapter field. The left connection is marked [00000000], the right connection [00000001].

• Enter the new IP address in the IP Address field. The three first digit blocks must conform to the digit blocks of your network. The last digit block can be selected, but the number must be unique.

• Change the subnet mask in the Subnet Mask field.

• Click on the Change IP button. The message "The static IP was set successfully." appears.

• If available, you should enter Gateway and DNS-Server.

• Now you can close the Network Configurator.


Installation

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Printer installation for the i.Profiler ® plus


The printer must be set up outside the patient environment (1.5 m from the patient’s seat at the device) and plugged into a separate socket. The user should not simultaneously touch the patient and the printer.

If the printer is to be operated in the patient environment, it must be additionally connected via an isolation transformer.

CAUTION - RISK DUE TO FAULTY DATA

Only a PostScript-capable network printer may be used.

The i.Profiler ® plus only supports PostScript® printers that can be connected via the Ethernet or a printer server. A network-compatible PostScript printer can be connected directly to the i.Profiler ® plus (peer-to-peer) or over a network.

Keep the user manual for the printer or printer server at hand. The printer must be configured according to the instructions contained in the user manual for the printer or printer server.

Installation

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Connecting the printer to the i.Profiler ® plus directly (peer-to-peer)

• Connect the network printer or printer server with the i.Profiler ® plus using a crossover cable or a standard cable with a crossover adapter.

• Switch on the i.Profiler ® plus and the printer or printer server.

• Configure the network printer or printer server with the aid of the user manual provided with the device as follows:

IP address: 192.168.103.6, if using the right network connection and 192.168.100.6, if using the left network connection of the i.Profiler ® plus, see page 22 (1, Fig. 9).

Subnet mask: 255.255.255.0

Standard gateway: 0.0.0.0

• In the Settings - Maintenance window (see Software description of the i.Profiler ® plus), select the Printer configuration option (administrator privileges required). The Message dialog will open. Confirm with Yes. The Printer Setup dialog for configuring the printer appears.

• Press the Add New Printer button. The Printer Configuration dialog appears. Follow the prompts appearing on the screen.

• Enter the IP address which has been set on the network printer or printer server.

• Press the Test button. When the connection is successful, a green check mark will appear.

• Confirm the selection with Finished. The printer appears in the list of the Printer Setup dialog.

• Press the Properties button. Ensure that the Portrait print format is set.

• Press the Print Testpage button. A test page will now be printed to confirm that the printer has been installed successfully.

• Press the Close button, in order to close the Printer Setup dialog. The device will restart.

Installation

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Connecting the printer via an existing network

The administrator responsible for your local network must first set up a network printer or printer server in the network.

The procedure for printer configuration is described in the user manual for the network printer or printer server. The IP address and subnet mask to be used will be assigned by the administrator.

• Switch on the i.Profiler ® plus and the printer or printer server.

• In the Settings - Maintenance window (see Software description of the i.Profiler ® plus), select the Printer configuration option (administrator privileges required). The Message dialog will open. Confirm with Yes. A dialog for configuring the printer will appear.

• Press the Add New Printer button. The Printer Configuration dialog appears. Follow the prompts appearing on the screen.

• Enter the IP address of the printer.

• Press the Test button. When the connection is successful, a green check mark will appear.

• Confirm the selection with Finished. The printer appears in the list of the Printer Setup dialog.

• Press the Properties button. Ensure that the Portrait print format is set.

• Press the Print Testpage button. A test page will now be printed to confirm that the printer has been installed successfully.

• Press the Close button, in order to close the Printer Setup dialog. The device will restart.

Installation

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Configuration of a network memory device


If the NAS device is not supplied with electricity via an isolation transformer it must be located at least 1.5 m from the patient to prevent the latter from touching the device with any part of his/her body during the examination. Nor should the operator touch the patient and the peripheral device simultaneously during an examination. If this warning is not observed, the patient and/or operator is liable to receive an electric shock.

This section contains instructions for configuring a network attached storage device or NAS device for use with the i.Profiler ® plus. These instructions specify the requirements and recommendations for the NAS device. Either a Carl Zeiss Vision NAS device or an NAS device from a preferred supplier that satisfies these requirements (generic NAS device) may be used. The NAS device may be plugged directly into the Ethernet connection of the i.Profiler ® plus or to your practice network (LAN). Both methods of connection are described in these instructions.

Once the NAS device has been installed and configured for use with the i.Profiler ® plus, it functions as a network server primarily for archiving purposes. The instructions for the use of a network server also apply analogously to the NAS device.

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Requirements made on the NAS device

The NAS device must have the following features to guarantee safety and acceptable performance in use of the i.Profiler ® plus:

• Support of 100BaseT or 1000BaseT Ethernet. For safety reasons a USB connection is not permissible with the i.Profiler ® plus.

• Crossover cable or a non-crossover cable with a crossover adapter for direct connection to the i.Profiler ® plus: UTP CAT5e cable with an RJ-45 jack, at least 3 m long, so that the NAS device can be located outside the reach of patients (see above safety precautions).

Recommendations for the NAS device

• Storage capacity: Should be at least as large as the storage capacity of the i.Profiler ® plus hard drive.

• Data storage: To ensure unlimited redundancy in data backup, we recommend using data backup software of your choice for the NAS device.

• Several NAS devices may be used for data backup. However, when two or more NAS devices are used simultaneously, a switch or router will be required. The switch/router may be connected directly to the i.Profiler ® plus or another point in the LAN. The user is responsible for the configuration.

Installation

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Installation of the NAS device

Connecting the NAS directly to the i.Profiler ® plus (peer-to-peer)

When connecting the NAS device directly (peer to peer) to the i.Profiler ® plus the left-hand network port must be used.

• With the i.Profiler ® plus and NAS device switched off connect the NAS device using a so-called crossover cable directly to the i.Profiler ® plus. Detailed instructions on how to install the NAS device are provided in the manual accompanying the NAS device.

Observe the safety precautions and requirements regarding cable type and length.

• Switch the NAS device on and wait until initialization has been completed

before switching on the i.Profiler ® plus. A light at the front of the NAS device often indicates by a change of color that initialization has been completed. For more detailed instructions see the manufacturer's operating manual.

Installation of the Carl Zeiss Meditec (CZM) NAS device

• Switch the i.Profiler ® plus on. After the start, quit the i.Profiler ® plus software by pressing the Close Application button in the Shut Down window+ and switch to the Microsoft Windows desktop (administrator rights required). The LAN connection may be indicated in the task bar bottom right when the NAS device is connected. Ignore this message for the time being.

• Double-click on the Initialize CZM NAS Mapping program icon on the

Microsoft Windows desktop to connect the CZM-NAS device with the drive letter N:\.

• Double-click on the Save Configurations program icon on the Microsoft Windows desktop to save the configuration. The device will restart.

Installation

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Installation of a generic NAS device

• Configure the NAS device using the device-specific manual as follows:

IP address: 192.168.100.7

Subnet mask: 255.255.255.0


• Generate a local directory on the NAS device.

• Generate a user account on the NAS device. It is recommended to use the user name "Zeiss" and the password "November171846".

• If a Workgroup is available, it is recommended to name it "CZM".

• Release the local directory on the NAS device with reading and writing rights for the user account previously generated.

Configuration of a generic NAS device on i.Profiler ® plus

• Switch the i.Profiler ® plus on. After the start, quit the software by pressing the Close Application button in the Shut Down window and switch to the Microsoft Windows desktop (administrator rights required). The LAN connection may be indicated in the task bar bottom right when the NAS device is connected. Ignore this message for the time being.

• Open Windows Explorer and select Tools from the menu bar.

• Select Map Network Drive…. The Map Network Drive dialog appears.

• Select the drive letter N:\ in the Drive field.

• Enter the IP address of the NAS device and the released directory in the Folder field as follows: \\192.168.100.7\"local directory"

• Make sure that the Reconnect at logon checkbox is selected.

• Confirm the entries by clicking on Finish.

• If required, the user name and password of the user account previously generated on the NAS device must be re-entered.


Installation

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Connecting the NAS device via an existing network • With the i.Profiler ® plus and NAS device switched off connect the NAS

device to the practice network (LAN) in which the i.Profiler ® plus is located. Detailed instructions on how to install the NAS device are provided in the manual accompanying the NAS device.


• Switch the NAS device on and wait until initialization has been completed

before switching on the i.Profiler ® plus. A light at the front of the NAS device often indicates by a change of color that initialization has been completed. For more detailed instructions see the manufacturer's operating manual.

• Switch the i.Profiler ® plus on. After the start, quit the i.Profiler ® plus software by pressing the Close Application button in the Shut Down window+ and switch to the Microsoft Windows desktop (administrator rights required). The LAN connection may be indicated in the task bar bottom right when the NAS device is connected. Ignore this message for the time being.

• Open Windows Explorer. Enter the signs "\\" followed by the IP address

or the name of the NAS device in the field Address. Confirm with Enter. The released directories of the NAS device are shown.

• Select an existing folder or create a new folder to which the data from the i.Profiler ® plus is to be saved.

• Open the Tools menu from the menu bar. Select Map Network Drive… The Map Network Drive dialog appears.

• Select a free drive letter in the Drive field.

• Click the Browse... button, the dialog Browse For Folder appears. Select the path to the folder in which the data will be saved. You can enter this path directly in the Folder field. Select Reconnect at logon.


• If required, the user name and password of the user account previously generated on the NAS device must be re-entered.


Installation

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Installation of the Atlas Review Software connection

The Atlas Review Software is optionally available and will not be offered in all countries.

To install the Atlas Review Software on a PC follow the user manual Atlas Corneal Topography System Review Software until chapter Connecting the Review Station to an ATLAS Instrument.

Please contact Carl Zeiss Meditec, Inc. if you need installation support.

Connecting the PC with the Atlas Review Software directly to the i.Profiler ® plus (peer to peer)

• Connect the PC to the i.Profiler ® plus using a so-called crossover cable or a non-crossover cable with a crossover adapter.


• Switch on the PC.

• Configure the PC with the aid of the user manual provided with the device as follows:

IP address: 192.168.103.101, when using the right network connection or 192.168.100.101 when using the left network connection of the i.Profiler ® plus, see page 22 (1, Fig. 9).

Subnet mask: 255.255.255.0


• Generate a local directory on the PC.

• Create a user account on the PC under the name "iProfiler" and using the password "iProf08_CZM".

• Release the local directory on the PC with reading and writing rights for the user account previously created.

• Switch the i.Profiler ® plus on. After the start, quit the i.Profiler plus software by pressing the Close Application button in the Shut Down window+ and switch to the Microsoft Windows desktop (administrator rights required). The LAN connection may be indicated in the task bar bottom right when the PC is connected. Ignore this message for the time being.

Installation

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Installation of the Atlas Review Software connection

• Double-click the program icon Initialize Atlas Review Mapping on the Windows desktop and select the network connector used (peer to peer connection) in the Initialize Atlas Review Station Connection dialog to connect the PC with the drive letter R:\. The device will restart.

Configuration of software on the i.Profiler ® plus

• In the Settings window under General the ATLAS Auto-Sync function can be switched on and off with the ATLAS Auto-Sync toggle switch. Use the … button to select the drive letter R:\ where you want to save the archive of the Atlas Review Software.

Configuration of the Atlas Review Station

• Click on Archive and then on Synchronize volume in the Review Station. The Archive directories to be synchronized dialog is displayed.

• Click on Add and use the Open dialog to select the ATLAS/ i.Profiler ® plus archive file "Archive.xml" in the local directory. Click on Open to add this archive to the list of archives which are to be synchronized with the Review Station. Confirm with "Yes".

• To make the i.Profiler ® plus data available on the Review Station you must click on Archive and then on Synchronize. Depending on the size of the ATLAS/i.Profiler ® plus archive synchronization may last a long time. As soon as synchronization is completed, the data of the i.Profiler ® plus can be displayed and analyzed on the ATLAS Review Station.

• Select Show today's patients to select imported patients.

• Select the Auto option under Options - Settings - Archive/ Synchronize - Synchronize on the ATLAS Review Station in order to automatically synchronize the databases which are archived in the network with the ATLAS Review PC.

Installation

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Connect Atlas Review Software via an existing network with i.Profiler ® plus

Notes on integrating the i.Profiler ® plus into an existing network you will find in the section Integrate i.Profiler ® plus into an existing network via DHCP, page 24.

Connect the i.Profiler ® plus with a network server.

• Switch the i.Profiler ® plus on. After the start, quit the i.Profiler ® plus software by pressing the Close Application button in the Shut Down window and switch to the Windows desktop (administrator rights required).

• Open Windows Explorer. Enter the characters "\\" and then the IP address

or the name of the storage medium in the Address field (e.g. network server, PC and Atlas Review Installation, NAS device) to which the Atlas/i.Profiler ® plus archive is to be saved. Confirm with Enter. The released directories of the storage device are shown.

• Select an existing folder or create a new folder to which the data from the i.Profiler ® plus is to be saved.

• Open the Tools menu from the menu bar. Select Map Network Drive… The Map Network Drive dialog appears.


• Click the Browse... button, the dialog Browse For Folder appears. Select the path to the folder in which the data will be saved. You can enter this path directly in the Folder field. Select Reconnect at logon.


• If required, the user name and password of the user account previously created on the storage device must be re-entered.


Configuration of software on the i.Profiler ® plus

• In the Settings window under General the ATLAS Auto-Sync function can be switched on and off with the ATLAS Auto-Sync toggle switch. Use the ... button to select the drive letter of the previously connected network drive to which the Atlas/i.Profiler ® plus archive of the Atlas Review software is to be saved.

Installation

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Connection of the ATLAS Review Station to a network server

• Switch on the PC with the Atlas Review Software installation.

• Open Windows Explorer. Enter the characters "\\" and then the IP address or the name of the storage medium in the Address field (e.g. network server, NAS device) to which the Atlas/i.Profiler ® plus archive is to be saved. Confirm with Enter. The released directories of the storage device are shown.

• Select the folder in which the Atlas/i.Profiler ® plus archive is stored.

• Open the Tools menu from the menu bar. Select Map Network Drive…. The Map Network Drive dialog appears.


• Click the Browse... button, the dialog Browse For Folder appears. Select the path to the folder to which the data will be saved. Or enter the path directly in the Folder text box. Select Reconnect at logon.


• If required, the user name and password of the user account previously created on the storage device must be re-entered.

Configuration of the Atlas Review Station

• Click on Archive and then on Synchronize volume in the Review Station. The Archive directories to be synchronized dialog is displayed.

• Click on Add and use the Open dialog to select the ATLAS/ i.Profiler ® plus archive file "Archive.xml" in the local directory. Click on Open to add this archive to the list of archives which are to be synchronized with the Review Station. Confirm with "Yes".

• To make the i.Profiler ® plus data available on the Review Station you must click on Archive and then on Synchronize. Depending on the size of the ATLAS/i.Profiler ® plus archive synchronization may last a long time. As soon as synchronization is completed, the data of the i.Profiler ® plus can be displayed and analyzed on the ATLAS Review Station.

• Select Show today's patients to select imported patients.

• Select the Auto option under Options - Settings - Archive/ Synchronize - Synchronize on the ATLAS Review Station in order to automatically synchronize the databases which are archived in the network with the ATLAS Review PC.

Daily use

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Daily use


Prior to using the device, the user must ensure that it is in a good condition and fully functioning. Furthermore, the user must follow the instructions in the user manual.

The following inspections must be carried out each working day prior to use:

• Visual inspection of the housing, labels, user manual, accessories, and power cable is necessary to ensure that they are present and intact. If parts are missing or damage is visible, the device should not be used and should be taken out of service.

• The ventilation slits in the casing should not be covered or otherwise obstructed!

• Test of measuring functions on the test eye pair.


Please take care that the following operational requirements are met each time before using the device and maintained throughout further operation:

• Use the power cable supplied with the device. If the device is mounted to an instrument table, it is powered through this table. If using a table not approved by Carl Zeiss Vision, the user is solely responsible for ensuring the electrical safety of the device.

• The power plug must be inserted into a power outlet that has an intact protective earth connection.

• Cables and plugs may be used only if they are in perfect condition.

Daily use

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Switching on

• To switch on the device, press the power switch (6, Fig. 9) followed by the Standby button (3, Fig. 6). The i.Profiler ® plus software is automatically launched and the Patient window will open.

• After switching on, a function test of the measurement functions on the test eye pair must be performed pursuant to the instructions in the i.Profiler ® plus Software description.

CAUTION - RISK OF MEASURING ERRORS

The calibration of the test eye pair should be checked each day prior to measurements on patients. The measured values can be printed out and filed for documentation purposes. If the values obtained from the test eye pair are not within the given tolerances, no patient measurements may be taken! The device must be taken out of service immediately (see section Shutting down, page 45).

Operation

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Operation

User's safety obligations


When operating radio devices or components for radio transmission, observe the distances recommended in section Electromagnetic compatibility, page 56 ff.

Users should not rely solely on measurements made using the Profiler ® plus in making decisions regarding the adaptation and prescription of visual aids or therapeutic procedures, etc., but should rely on their own expertise and judgment.

Users should compare measurement results obtained with the i.Profiler ® plus with other diagnostic data (e.g. ophthalmometer, patient’s refraction data).


The patient should not touch the device with his/her hands. In particular, the device should not be used as a support or standing up aid.

Measurements may only be performed on a patient in a sitting position.

More precise instructions for backing up the database can be found in the Software description for the i.Profiler ® plus.

The Software description can be opened in any main window of the i.Profiler ® plus software with a mouse click on the question mark in the top right corner of the window.

Operation

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Work sequence

The following work sequence is recommended:

• Explain the i.Profiler ® plus measurement procedure to the patient.

• Open the patient database and enter the data of the patient to be measured if it does not already exist (Patient Database window).

• Position the patient for measurement (see page 44).

• Select the patient to be measured in the database and start measurements (Measurement window).

• Complete the measurements and evaluate your results using the preview images (Preview window). Insofar as they are acceptable, save your readings. Otherwise repeat the measurement.

• Analyze your readings (Review and Analysis windows).

• After analyzing the data, switch to the patient database to select the next patient or enter new patient data.

Operation

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Explaining the i.Profiler ® plus measurement procedure to the patient


Persons who are not authorized to use the device (see chapter Specified purpose, page 7) may not be left unattended at or in the vicinity of the device.


A misinterpretation of results may occur in the following patient categories or measurement may not be possible.

• Unable to steadily fixate the fixation mark with the eye under examination (e.g. in the case of nystagmus, extremely poor visus, lack of concentration)

• Unable to follow the instructions of the user

• Unable to position him/herself upright in front of the medical device

• Lacking transparency of the optical media of the eye for wavefront/ refraction measurements (e.g. cataract with lens clouding stronger than grade NO1 according to LOCS III (Lens Opacity Classification System III)

• Deficient specular reflection of the cornea for topography or wavefront measurements (e.g. distortion of the tear film, scarring or caustic burn of the cornea)

• Pupil opening too small (< 2 mm) for wavefront measurement

• Complete or partial coverage of the pupil caused by closed or inadequate palpebral fissure

• Forehead or chin injuries that prevent the head from being supported on the head/chin rest

• Morphological changes of the retinal anatomy in the region of the fovea for wavefront/refraction measurements (e.g. retinal detachment, edema, ulcer)

• Refractive errors or keratometry outside the measurement range

Operation

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The wearing of rigid or soft contact lenses may have an effect on the surface geometry of the cornea and thus the optical state of the eye.

For topography and wavefront measurement of wearers of soft lenses a rest period of at least two weeks should thus be observed from the time the lens is removed to the time of measurement.

For wearers of rigid lenses the time from removal of the lens to the time of measurement should be at least three weeks. Two measurements must be made of the central keratometry and two of the manifest refraction at an interval of at least one week. These may not diverge from each other by more than 0.5 D for each meridian. The Placido ring images must be normal.

• Explain to the patient that measurements with the i.Profiler ® plus are

contactless.

• Prior to performing measurements, inform the patient about the procedure (appearance of a red light).

• Watch out for foreign bodies in the tear film (e.g. eyelashes). Ask the patient to blink once or twice before starting the measurement procedure.

Operation

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Positioning the patient for measurements

• Renew the upper paper pad on the chin rest after each patient.

• Ask the patient to position his/her chin on the motorized chin rest and forehead against the forehead rest.

• Ensure that the patient's chin is on the front edge of the chin rest.

• At least half of the patient's pupil must be visible. If this is not the case, adjust the height of the chin rest until the patient's pupil is in the window.

• Ask the patient to look through the opening in the device at the test mark - a picture of a long road with a hot air balloon in the distance. To rule out accommodation, the patient should concentrate on the stripes on the balloon.

• If the patient fails to see the balloon at first, ask him or her to continue looking until the balloon appears.

• Ask the patient shortly before the measurement to avoid any movement during measurements and hold the eye open as far as possible as well as not to blink.

• Start the measurement by clicking on the Measure button in the Measurement dialog. The automatic measurement procedure starts.

To minimize measurement errors due to tear film changes when the eye is opened too long, the patient should be asked to blink several times immediately before the measurement procedure.

• Ask the patient to blink again shortly after completing the centration, but still during focusing. The display above the image window shows the following: Centering √ Focusing….

• Prior to wavefront measurement ask the patient to continue looking at the balloon, even when the red laser light appears.

Shutting down

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Shutting down

Switching off the device

• To switch off the i.Profiler ® plus software, click on the corresponding buttons in the software interface or use the standby button (3, Fig. 6).

• Switch the device off by the power switch (6, Fig. 9) after the blue lamp next to the standby button goes off.

Turn the device off by the power switch if it is not used during the night.

Device components still remain under voltage when the device has been switched off at the power switch. Complete disconnection from the power supply is only possible by pulling the power cable.


If one of the following events should occur, switch the device off immediately at the power switch, disconnect the power cable, label the device clearly as being out of service and report the problem to Carl Zeiss Vision

• Electric shocks

• Penetration of spilled substances

• Faults that cannot by remedied according to the descriptions in this user manual.


The light next to the standby button must be turned off before switching off the power switch, unplugging from the power supply or switching off the main room switch. Failure to observe these instructions may result in loss of data.

Shutting down

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If the device is switched off at the standby button (3, Fig. 6) while it is in operation, the program will quit automatically before the device switches to standby mode. Wait until the blue light beside the standby switch goes off before switching off at the power switch (6, Fig. 9), pulling the power supply plug or switching off at the main room switch.

If you switch off the device while it is in operation, pull the power supply plug or switch off the main room switch the program and the operating system cannot be shut down properly. This can lead to the loss of stored data and/or errors in the control software of the device. This does not present a hazard to patients or the operator.

Maintenance and care

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Further maintenance procedures above and beyond those specified in this section (maintenance, safety inspections and repairs) may only be carried out by persons authorized by Carl Zeiss and solely according to the service instructions issued by Carl Zeiss.

Fault remedy

The following troubleshooting tables list possible problems encountered in the operation of the i.Profiler ® plus together with the appropriate remedies. Should problems persist, please contact Carl Zeiss Vision.

Problems with the electric system

Fault/Problem Possible causes Remedy

The standby control lamp does not light up when the power switch has been switched on and the standby button has been pressed.

Power plug is not connected.

The fuses are defective.

Ensure that the power plug is connected to the power supply.

Check the fuses in the power switch module (see page 51).

The device switches on, but no screen display appears and the device head does not move.

Cable problem Contact customer service.

The device will not power up or the application will not start.

Computer problem Switch the device off, wait a minute before switching it on again. If the problem persists, contact customer service.


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Monitor problems


Display is black & white or the colors are distorted.

Monitor problem

Cable problem

Contact customer service.

Display colors change when monitor is moved.

Cable problem Contact customer service.

Problems with the internal printer


The internal printer will not print.

Paper jam

No paper

Open the paper compartment and remove the paper jam.

Replace the roll of paper.

Problems with the flexible optical measuring head


The optical measuring head does not move.

Cable problem

Controller problem

Switch the device off, wait a minute before switching it on again. If the problem persists, contact customer service.

The optical measuring head does not move properly.

Poor motor initialization

Optoswitch problem

Controller problem

Cable problem


Movements are unusually loud.

Mechanical or electronic problem



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Measurement problems


Centering phase

The patient's eye is misaligned upwards and cannot be centered with the aid of the touchscreen (error message appears).

The chin rest is set too high.

Correct the height of the chin rest.

The patient's eye is misaligned downwards and cannot be centered with the aid of the touchscreen (error message appears).

The chin rest is set too low.

Correct the height of the chin rest.

The patient's eye is misaligned to the right or left and cannot be centered with the aid of the touchscreen (error message appears).

The patient's head is laterally misaligned.

The patient's head is tilted.

Correct the position of the patient's head in the chin rest.

Correct the angle of the head relative to the forehead rest (i.e. Turn Head or normal measuring mode).

The patient's eye is not detected.

The intensity of illumination in the area of the measuring head is too high.

Ensure that no external light source is affecting the detection of the eye.

If the problem persists, contact customer service.

The second eye of the patient is too high or too low.

The patient's head is not positioned vertically on the forehead rest.

Reposition the patient's head in the forehead rest.


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Focusing phase

The instrument head does not automatically focus (error message appears).

The patient's forehead is not against the forehead rest.

The patient is pseudo phakic or wearing contact lenses.

Ensure that the patient's forehead is firmly against the forehead rest.

Use manual focusing. If the problem persists, contact customer service.

Measuring phase

The device measures very slowly.

The patient has a cataract.

Gradually increase sensor sensibility.

The device does not measure at all.

The patient has a cataract.

Electrical problem

Gradually increase sensor sensibility.


The readings are corrupted.

The intensity of illumination in the area of the measuring head is too high.

Sensor produces "ghost" or double images.

The unit has not been calibrated.

The patient cannot fixate the internal test mark.

Ensure that no external light source is affecting the measurement result.



Instruct the patient to fix his/her sight on the test mark.


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Replacing the fuses


Disconnect the power cable from the power supply before replacing the fuse.

The fuses are located in the fuse box (5, Fig. 9, page 22) to the right of the power switch of the i.Profiler ® plus.

1 Fuses

2 Fuse carrier

3 Lid of fuse box

Fig. 10 Replacing fuses in the i.Profiler ® plus

• Unplug the power cable. The fuse box can only be opened after unplugging the power cable.

• Open the lid of the fuse box (3, Fig. 10).

• Remove the red fuse carrier (2, Fig. 10) with the two fuses (1, Fig. 10).

• Replace the defective fuse and reinsert the fuse carrier with fuse.

• Close the lid of the fuse box.

Use only fuses listed in chapter Technical data, page 54.


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Maintenance

Replacing the print paper roll


Disconnect the power cable from the power supply before replacing the printing paper.

• Open the paper compartment at the right hand side of the device

(8, Fig. 9, page 22).

• Remove the empty paper roll and insert a new roll according to the drawing on the inside of the compartment.

• Pull out the end of the print paper roll so that it remains visible when the cover has been closed.

• Close the printing paper compartment.

Care and cleaning


Prevent moisture from penetrating the instrument or keyboard. Disconnect the power cable from the power supply before cleaning or disinfecting the device.

CAUTION - RISK DUE TO CROSS-CONTAMINATION

Parts with which the patient has come into contact during the examination (chin rest, forehead rest) should be cleaned with a disinfectant approved for the purpose. These parts are resistant to wiping off with cleaning agents categorized as "low" (e.g. suds, quaternary ammonium compounds) and "intermediate" (e.g. alcohol, Javel water, iodine); classification pursuant to: Disinfectants and activity spectrum according to the Center for Disease Control and Prevention, Atlanta, USA).


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The national disinfecting regulations must be observed in the choice of disinfectants and methods. Please note that some cleaning agents and disinfectants may have an adverse effect on plastic components. Damage caused by such disinfectants is not covered by our warranty. The surfaces of the device have been tested to resist frequent treatment with alcoholic disinfectants and cleaning agents in the long term.

Please note that some cleaning agents and disinfectants may have an adverse effect on plastic components. Damage caused by such disinfectants is not covered by our warranty.

Never use aggressive or abrasive cleaning agents.

Never clean the exit aperture of the measuring optics (4, Fig. 7, page 18).

The exit aperture of the measuring optics is inspected for contamination at every scheduled safety inspection. It may only be cleaned by a Carl Zeiss Vision representative.

• All parts of the casing may be wiped off with a moist but not drip-wet

cloth. Wipe off any marks or stains with distilled water, to which a drop of household soap has been added.

• Use conventional cleaning cloths for wiping off the display and keyboard of computers and monitors.

• Remove dust from optical surfaces by means of a fine brush.

• To protect from dust, cover the device using the dust cover provided when not in use.


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Technical data

i.Profiler ® plus basic unit

Model designation i.Profiler ® plus

Dimensions (footprint)

Weight

420 mm x 310 mm

approx. 30 kg

Power connection 100 V~ to 240 V~

Supply frequency 50 Hz to 60 Hz ≤ 200 VA

Power consumption ≤ 200 VA

Maximum sound pressure level 55 dB (A) in accordance with measuring method described in IEC 60601-1 :2005, Chapter 9.6.2.1

Type of protection against electric shock:

Device of protection class I

Degree of protection against the penetration of water and foreign bodies

IP 20

Degree of protection against electric shock

B

Laser data at device output

Laser class at device output Wavelength Maximal power output

1 785 nm 393 µW

Laser data of internal laser sources

Laser class Wavelength Maximal power output

3R 785 nm 3 mW

LED sources:

Photoptic illumination

Wavelength Maximal power output

525 µm 39 µW

Infrared illumination (2 lamps)


880 nm 338 µW

Placido ring illumination


950 nm 1398 µW

Fixation illumination

Max. power output

Whitelight LED

0.2 µW

Fuse 2 x T 3 E 250 V (manufacturer: Littelfuse, Order No.: 313003P)

Battery CR 2032


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Ambient conditions for intended use and on-site storage

Operating temperature

Relative humidity

Altitude

+10 °C to +40 °C

30 % to 85 % non-condensing

up to 3000 m above sea level

Note: We reserve the right to make changes to the design and package check list in accordance with technical advances.

Ambient conditions for off-site transport and storage in original packaging

Storage/transport temperature

Relative humidity

-20 °C to +60 °C℃

Max. 95 % non condensing

Measuring range

Wavefront Range of action sphere: -20 D to +20 D (3.5 mm pupil)

Range of action sphere: -15 D to +15 D (5.5 mm pupil)

Range of action cylinder: 0 D to +8 D

Axis: 0° to 180°

Measuring surface: 2.0 mm to 7.0 mm (three zones)

Number of measuring points: up to 1,500

Acquisition time: 0.2 s

Method: Hartmann-Shack

Reference wavelength1: 555 nm acc. to ISO 24157

Corneal topography No. of rings: 22 (18 complete rings)

Number of measuring points: up to 3,425

Detected corneal surface at 42.125 D: ∅ 0.75 mm to 9.4 mm

Diopters: Measuring range: 25 D to 65 D

Accuracy: ±0.05 D (±0.01 mm)

Reproducibility: ±0.10 D (±0.02 mm) and type A acc. to ISO 19980

1 Reference wavelength for the interpretation of refractive errors (corresponds to maximum luminous efficiency curve Vλ of the eyes of test persons in daylight)

Electromagnetic compatibility

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Guidance and manufacturer's declaration - electromagnetic emissions

The i.Profiler ® plus is intended for use in the electromagnetic environment specified below. The customer or the user of the i.Profiler ® plus should assure that the device is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11 Group 1 The i.Profiler ® plus uses RF energy only for its internal function. Therefore, its RF emissions are therefore very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B The i.Profiler ® plus is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2 Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies


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Guidance and manufacturer’s declaration - electromagnetic immunity


Immunity checks IEC 60601-1-2 test level

Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Fast transient electrical disturbances/burst IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

±1 kV for input/output lines

Mains power quality should be that of typical commercial or hospital environments.

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±2 kV line(s) to earth

±1 kV line(s) to line(s) ±2 kV line(s) to earth

Mains power quality should be that of typical commercial or hospital environments.

Voltage dips, short interruptions to the power supply and voltage variation on power supply input lines IEC 61000-4-11

< 5 % UT (> 95 % dip in UT) for 1/2 cycle

40 % UT (60 % dip in UT) for 5 cycles


< 5 % UT (> 95 % dip in UT) for 5 s

< 5 % UT (> 95 % dip in UT) for 1/2 cycle



< 5 % UT (> 95 % dip in UT) for 5 s

Mains power quality should be that of typical commercial or hospital environments. If the user of the i.Profiler ® plus requires continued operation during power mains interruptions, it is recommended that the i.Profiler ® plus be powered from an uninterruptible power supply or a battery.

Note: UT is the a.c. mains voltage prior to application of the test level.


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Guidance and manufacturer’s declaration - electromagnetic immunity


Immunity test IEC 60601-1-2 test level

Conformity level Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

[U1] 3 V Portable and mobile RF communications equipment should be used no closer to any part of the i.Profiler ® plus, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = PU

3.5

1

d = P1E

3.5 80 MHz to 800 MHz

d = PE

7

1 800 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 strengths form fixed RF transmitters, as determined by an electromagnetic site survey a , should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol.

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

[E1] 3 V/m

Note 1: At 80 and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations from 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 asses 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 i.Profiler ® plus is used exceeds the applicable RF compliance level above, the i.Profiler ® plus should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the i.Profiler ® plus.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.


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Recommended separation distances between portable and mobile RF communications equipment and the i.Profiler ® plus

The i.Profiler ® plus is intended for use in an electromagnetic environments in which related RF disturbances are controlled. The customer or the user of the i.Profiler ® plus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the i.Profiler ® plus as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter

P [W]

Separation distance, according to frequency of transmitter

d [m]

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = PU

3.5

1

d = PE

3.5

1

d = PE

7

1

0.01 0.117 0.117 0.233

0.1 0.370 0.370 0.737

1 1.170 1.170 2.330

10 3.700 3.700 7.368

100 11.700 11.700 23.300

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, in which P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 and 800 MHz the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Abbreviations/Glossary

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Abbreviations/Glossary

DIN Deutsches Institut für Normung (German Standards Institute)

EN European standard

EU European Union

Fig. Figure

IEC International Electrotechnical Commission

LAN Local area network

Local network

LOCS III Lens opacity classification system III

Lens clouding classification system

NAS Network attached storage

Network attached storage device

RJ-45 Registered jack

Standard plug-type connector for data lines

USB Universal serial bus

Standard interface for PC peripheral devices

UTP CAT Unshielded Twisted Pair Category

Figures

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Figures

Fig. 1 Type plate on the i.Profiler ® plus ............................................ 10 Fig. 2 Measuring principle of the Hartmann-Shack sensor .............. 12 Fig. 3 Image of light spots on the camera chip (A) and image

of the reconstructed wavefront map (B) over the total exit pupil. ............................................................................ 13

Fig. 4 Imaging beam path of a topography measuring device with a Placido disc. .............................................................. 14

Fig. 5 The image of the rings of the Placido disc on the camera for a normal cornea (A) and a distorted cornea (B). .............. 15

Fig. 6 i.Profiler ® plus, view from the operator side ........................... 17 Fig. 7 i.Profiler ® plus, view from the patient side ............................. 18 Fig. 8 Recessed handles on the underside of the i.Profiler ® plus ....... 21 Fig. 9 Connection panel on the i.Profiler ® plus ................................. 22 Fig. 10 Replacing fuses in the i.Profiler ® plus ..................................... 51

Index

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Index

A Abbreviations ............................................................................................ 60 Accessories ................................................................................................. 5

C Care .......................................................................................................... 52 Classification of the device .......................................................................... 6 Components ............................................................................................. 17 Connection panel ...................................................................................... 22 Connections.............................................................................................. 22 Controls .................................................................................................... 17

D Data entry................................................................................................. 20 Description of the device........................................................................... 17 Disposal ...................................................................................................... 9

E Electromagnetic compatibility ................................................................... 56

F Fault remedy ............................................................................................. 47 Figures ...................................................................................................... 61 First-time set-up ........................................................................................ 38 Function test ............................................................................................. 39 Functional description ............................................................................... 12 Fuses ........................................................................................................ 51

I Intended use ............................................................................................... 6

K Keyboard .................................................................................................. 20

M Maintenance ............................................................................................. 52 Maintenance and care .............................................................................. 47 Manufacturer's declaration ......................................................................... 6

N NAS device ............................................................................................... 30 Network attached storage device .............................................................. 29

Index

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P Patient

Explanation ............................................................................................ 42 Positioning ............................................................................................. 44

Performance specifications ........................................................................ 12 Printer installation...................................................................................... 26

R Recessed handles....................................................................................... 21

S Service life ................................................................................................. 16 Shutting down .......................................................................................... 45 Software description.................................................................................. 40 Specified purpose ........................................................................................ 7 Symbols ....................................................................................................... 4

T Technical data ........................................................................................... 54 Topography measurement ......................................................................... 14

W Wavefront measurement ........................................................................... 12 Work sequence ......................................................................................... 41

Carl Zeiss Vision GmbH Turnstrasse 27 73430 Aalen Germany

000000-1520-928_GA_EN_021013 i.Profiler ® plus

Specifications subject to change

Hardware Manual IPP-DE

Documents

Transcript of Hardware Manual IPP-DE