IOLMaster 500 Documentation Set July 2015

© 2015, Carl Zeiss Meditec AG, Jena All rights reserved in the event of granting of patents or registration as a utility patent. All names of companies and products cited in this documentation set may be trademarks or registered trademarks. References to products of other manufacturers are for information purposes only. Such references are intended neither as an approval nor a recommendation of these products. Carl Zeiss Meditec AG accepts no liability for the performance or use of such products. Microsoft Windows® is a registered trademark of Microsoft Corporation, Inc. ® SRK is a trademark of Computational Technology, Inc. Other brand names, software and hardware names used in this documentation set are generally subject to trademark or patent protection. The quoting of products is for informational purposes only and does not represent a trademark misuse. The weblinks are dynamic hyperlinks. Before incorporating any links, Carl Zeiss Meditec AG checks their content to ensure that it is not likely to result in civil or criminal liability. It does not, however, continuously check for any changes which could form the basis for liability. If Carl Zeiss Meditec AG determines that a link which it has incorporated could result in civil or criminal liability, or is alerted to the fact by a third party, the link will be removed. This documentation set 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. In case of infringement, the violator may be liable to pay compensation for damages. Specifications due to technical developments are subject to change. This documentation set is not subject to the revision service. Please contact the manufacturer or authorized dealer to request the latest edition of the documentation set.

Content

User manual IOLMaster 500 with Advanced Technology [000000-1692-983-GA-GB-090715] Software description IOLMaster 500 with Advanced Technology [000000-1692-983-SWGA-GB-090715] Notes on and conditions of use for the remote maintenance tool [000000-1305-000_AddGA01_GB_040610]

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Appendix IOLMaster 500 - Quick instructions [000000-1692-983-KurzGA01-GB-071112] IOLMaster 500 - Optimization of lens constants [000000-1692-983-KurzGA02-GB-030112] Recommendations for avoiding errors in biometry and IOL calculation [000000-1692-983-KurzGA03-GB-090715]

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Content

User manual IOLMaster 500 with Advanced Technology [000000-1692-983-GA-GB-090715]

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IOLMaster 500 with Advanced Technology

User manual

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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 the symbols used ... 4

Package check list ...5 Country-specific information and labels ...6 Classification/Manufacturer's declaration ... 6 Intended use ... 6 Intended user profile... 8 Technicians or personnel performing measurements with the IOLMaster ... 8 Physician's assistants, nurses or other personnel performing data processing ... 8 Evaluation of measurement data ... 9

Disposal of the product ... 10 Labels ... 11

Performance specifications ...14 Functional description... 14 Service life ... 16

Description of the device...17 Installation ...19 Notes for installation and use ... 19 Installation ... 21 Electrical connection ... 22

Daily use ...23 Switching on ... 24 Checking the measurement functions ... 25 Mounting the test eye ... 26 Checking the axial length measurement and keratometer ... 27 Checking the anterior chamber depth measuring device ... 28 Verifying WTW measurements... 29

Operation of the device...30 User's safety instructions ... 30

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Contents

Shutting down ... 31 Switching off the device ... 31

Maintenance and care ... 33 Remote maintenance ... 33 Maintenance ... 34 Care and cleaning ... 34

Safety inspections ... 35

Optional accessories ... 37 Mounting the keyboard tray on the instrument table ... 37 Securing the device on the instrument table with the holding bracket ... 38 Printer installation for the IOLMaster ... 39 Peer-to-peer connection of printer with IOLMaster ... 40 Connection of printer via an existing network ... 40

Network isolator ... 41 Option Reference Image for IOLMaster ... 41 Questions and suggestions ... 41

Technical data ... 42 Electromagnetic compatibility ... 46 Abbreviations/Glossary ... 52 Figures ... 53 Index ... 54

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Notes on the user manual

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Notes on the user manual Purpose and availability of documentation This user manual and the software description of this device explain the safety precautions, functions, usage, performance parameters and measures for care and maintenance of the IOLMaster. 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 setting up and using the IOLMaster the first time. The user manuals and other documentation enclosed with the IOLMaster should be kept accessible to users at all times to ensure that the information required for use of the IOLMaster is readily available.

Questions and comments If you have any questions or comments concerning this user manual or the IOLMaster, please contact ZEISS customer service or your local dealer. (Contact details see reverse.)

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Notes on the user manual

Explanation of the symbols used The symbols used in this user manual refer to important safety information which warn against possible health risks or fatal injuries and contain useful notes. Whenever you see these symbols, read the accompanying information carefully and observe all safety notes and information in this user manual and on device labels.

WARNING Indicates a hazardous situation which could result in death or serious injury if the appropriate safety precautions are not heeded. CAUTION Indicates a hazardous situation which could result in minor or moderate injury if the appropriate safety precautions are not heeded. CAUTION - PROPERTY DAMAGE Indicates possible device damage if the appropriate safety precautions are not heeded.

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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 The device is delivered completely assembled in foam material packaging. The enclosed accessory box contains the following components: • Keyboard • Power cable • Documentation set • Dust cover • Test eye in its own case • USB drive • USB extension cable

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Country-specific information and labels

Country-specific information and labels Classification/Manufacturer's declaration WARNING - GENERAL HAZARDS This device may only be set up, operated and used for the specified purpose and according to national regulations, consistent with the applicable industry standards and occupational safety and accident prevention regulations. Further notes on classification are to be found in section Technical data, page 42 and following.

The device complies with EU directive 93/42/EEC (MDD). Device class according to MDD:

IIa

Laser class:

Class 1 according to DIN EN 60825-1:2008 3B

In device (not accessible): EMC:

See section Electromagnetic compatibility, page 46 and following.

UMDNS No.

18-014

This declaration shall be rendered invalid if changes are made to the device without the manufacturer's authorization.

Intended use The device is to be used only for the measurement of axial length, corneal curvature, anterior chamber depth and for the measurement of the white-towhite distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens. The user is liable for any use of the device other than intended.

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Country-specific information and labels

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CAUTION - RISK OF MEASURING ERRORS Measurements should never be performed through contact lenses, as this produces incorrect results. 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 measurement of wearers of soft lenses using IOLMaster a rest period of at least two weeks should thus be observed from the time the contact 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. Avoid measurements of eyes with retinal detachment. In such cases, measuring errors cannot be precluded. Avoid the use of eye drops prior to measurement, as they may lead to incorrect results, in particular in the measurement of corneal curvature. Do not perform anterior chamber depth measurements on pseudophakic eyes. Do not perform any contact measurements or examinations in which the eye is touched. They may result in incorrect readings, particularly for axial length and corneal curvature measurements. Contact measurements or examinations should only be performed after the patient has been measured with the IOLMaster. Do not use the IOLMaster in patients with the following conditions: • Unable to steadily fixate the fixation lights with the eye under examination (e.g. in the case of nystagmus, extremely poor visual acuity, lack of concentration) • Unable to follow the instructions of the user • Unable to sit upright in front of the device • Deficient specular reflection of the cornea for keratometry or anterior chamber depth measurements (e.g. distortion of the tear film, scarring or caustic burn of the cornea) • Complete or partial covering of the cornea caused by closed or inadequate coverage of the pupil • Forehead or chin injuries that prevent the head from being supported on the forehead/chin rest • Morphological changes of the retinal anatomy in the region of the fovea for axial length measurements (e.g. retinal detachment, edema, ulcer) • In the case of low transparency of the optical media of the eye (e.g. mature cataract, opacity of the posterior capsule, hemorrhage in the vitreous body) it may be difficult to measure the axial length (see also information in the software description).

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Country-specific information and labels

Intended user profile 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 also adhere to the national qualification guidelines applicable in your country.

Operators of the IOLMaster should have knowledge of basic eye examination and diagnostic procedures. The following pre-requisite skills are recommended for operators of the IOLMaster:

Technicians or personnel performing measurements with the IOLMaster • Performs medical (eye) history and screening procedures • Provides patient instructions during measurement procedures • Observes acoustic and optical warning signals and displays on medical devices • Uses computers and computer interfaces (USB, Ethernet, VGA) • Familiar with the Microsoft Windows operating system and applications based on it • Performs maintenance, cleaning and calibration procedures on medical devices

Physician's assistants, nurses or other personnel performing data processing In addition to the skills required for performing measurements, the user should have knowledge of pathological factors that influence measurement quality, in particular: • Cataract-related light scattering of optical media • Corneal opacity-related light scattering of optical media • Optimization of device settings, to minimize pathological factors that influence measurement quality

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Country-specific information and labels

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• Handling of standard measurement protocols and measurement results in optics/optometry such as refraction values (sphere, cylinder, axis), ophthalmometer values (corneal radii), axial length, anterior chamber depth and WTW • Evaluation of the quality of readings with the information provided by the IOLMaster user manual

Evaluation of measurement data Evaluation of measurement data should be performed by physicians (e.g. ophthalmologist, cataract surgeon, refractive surgeon) using the instructions provided in this manual.

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Country-specific information and labels

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, contact 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 or the manufacturer or its legal successor company. Please read the latest internet information provided by the manufacturer. Where the product or its components are resold, the seller must inform the buyer that the product is to be disposed of in accordance with the currently applicable national regulations.

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Country-specific information and labels

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Labels

Fig. 1

Warning and information labels on the device

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Country-specific information and labels

Item

Label

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Explanation IOLMaster type plate Manufacturer Date of manufacture Applied part type B AC voltage IP20

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REF 1692-983 SN XXXXXXX

Ingress protection rating of housing (protected against solid foreign bodies of 12.5 mm in diameter and larger, no protection against penetration of water)

IOLMaster identification label REF Catalogue number/part number SN Serial number Bottom: Serial number as bar code

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Sign with date of manufacture

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CE marking label and disposal advise for EU EU conformity symbol and identification number of notified body Disposal advise for EU

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Information sign "Disconnect device from the power supply before opening"

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Information sign "Observe user manual"

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REF 1521-639 SN XXXXXXX

IOLMaster computer identification label

Sign with IOLMaster Plug ID

Country-specific information and labels

Item

Label

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Explanation "Shutting down IOLMaster" sign

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Not applicable

Not applicable

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Not applicable

Not applicable

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Not applicable

Not applicable

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Performance specifications

Performance specifications Functional description The IOLMaster is a combined biometry instrument for measurements on the human eye required for the preoperative computation of intraocular lens power. It is capable of consecutive measurement of the following eye parameters in one session: axial length, corneal curvature, anterior chamber depth and WTW distance. All measurements are non-contact, providing excellent patient comfort. The axial length measurement is based on an interference optical method known as partial coherence interferometry (PCI). The displayed results of the axial length measurements are comparable to the ultrasonic immersion measurements of axial length via the use of an internal, statistically verified calculation algorithm. The familiar formulas for IOL calculation can thus be used. However, the lens constants must be changed for use with the PCI method. Manufacturer's constants are less suitable. Please consult the scientific literature on this subject. The corneal curvature is determined by measuring the distance between reflected light spots projected onto the cornea. The anterior chamber depth is determined as the distance between the optical sections of the lens and the cornea produced by lateral slit illumination. The white-to-white distance and pupil diameter are determined from the image of the iris.

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Depending on the brightness, the pupil size can fluctuate greatly during measurement. The readings may not be used to plan further treatment.

The individual measurement procedures are automated, so that the operator is only required to adjust the device to the patient's eye and initiate the measurement. For this reason the complex biometric procedures of the eye can rapidly be mastered with the IOLMaster, but should be practiced with the greatest of care and attention to detail. Extensive integrated safety features (independent redundant hard and software safety features) ensure maximum safety for both the patient and operator when using and operating the IOLMaster. The control program for the computer in the device base runs under Microsoft Windows. A backlit LCD serves to observe the patient's eye and display the readings. The device is controlled using the computer keyboard with integrated touchpad and the joystick at the basic device.

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