LS900 Software Manual Jan 2009

Instruction Manual EyeSuite Biometry "1. Introduction" Doc. Nbr. : 1500 7220056 01011 Page :1/1

1. Introduction We would like to thank you for your decision to purchase this Haag-Streit product. If the instructions in this manual are carefully followed we are confident that this product will give you reliable and trouble-free usage.

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Instruction Manual EyeSuite Biometry "2. Purpose of use" Doc. Nbr. : 1500 7220056 02021 Page :1/1

2. Purpose of use The LS 900 is a non-invasive, non-contact OLCR (optical low-coherence reflectometry) biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens. The LS 900 measures: • • • • • • • • •

Axial eye length Corneal thickness Anterior chamber depth Aqueous depth Lens thickness Radii of corneal curvature of flat and steep meridian Axis of the flat meridian White-to-white distance Pupil diameter

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Instruction Manual EyeSuite Biometry "3. Safety instructions" Doc. Nbr. : 1500 7220056 03021 Page :1/5

3. Safety instructions Contents • 1 General ... 2 • 2 Plausibility of measurements ... 2 • 3 IOL calculation ... 3 ◦ 3.1 References ... 3 • 4 IOL constants... 3 ◦ 4.1 IOL constants derived using optical measurements ... 4 ◦ 4.2 IOL constants derived using immersion ultrasound measurements ... 4 ◦ 4.3 IOL constants derived using contact ultrasound measurements ... 4 • 5 Warranty and product liability ... 4 • 6 Statutory requirements ... 4

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Instruction Manual EyeSuite Biometry "3. Safety instructions" Doc. Nbr. : 1500 7220056 03021 Page :2/5

General • The appliance must only be used for the purpose described in this operating manual. • The software must only be installed by persons trained to do so. • The PC on which the EyeSuite Biometry software is installed must not contain or run any other software that might limit the functioning capabilities of EyeSuite. • Please keep this manual near the appliance at all times, in a place where it can be accessed easily by operating staff. Warranty claims will only be considered if the instructions in the operating manual have been followed as specified. • Only suitably-trained and experienced staff must operate the software (for the generation of measuring data and calculations, along with the manual entry, editing and deletion of data) and interpret results. All members of operating staff must be suitably-trained and familiar with the contents of the operating manual, with particular reference to the safety instructions contained in it. • Shut down the computer whenever the system is to be out of use for an extended period. • Measurements can be carried out with dilated or undilated pupils. The A-scan (axial eye length, corneal thickness, anterior chamber depth, lens thickness), keratometry and white-to-white distance measurement are not influenced by dilatation status. Dilatation status does have a bearing on pupillometry.

Plausibility of measurements • Users should check measurement readings for plausibility. This involves verifying the A-scan and the cursor, which is automatically adjusted with respect to signal peaks, whenever the LS 900 displays an abnormally-high standard deviation for axial eye length, corneal thickness, anterior chamber depth and/or lens thickness. The operator should also take into account the type (e.g. posterior subcapsular cataract) and density of the cataract when evaluating plausibility. • Measurement readings obtained from patients with a non-intact cornea (e.g. due to a corneal transplant, corneal opacity or corneal scarring) may possibly be inaccurate (this applies to keratometry in particular), and the user should check the data for plausibility. • We recommended the carrying-out of five measurements on each eye. • The user should ensure, before carrying out the measurement procedure, that the patient is not wearing contact lenses, as their presence is likely to give rise to incorrect measurement readings. • It may not be possible, under certain circumstances, to carry out measurements on persons with fixation problems. • Dense lenticular opacities may make it impossible to measure the axial eye length and lens thickness. • Pronounced opacities of the central cornea can likewise make it impossible to measure corneal thickness, anterior chamber depth, lens thickness or axial eye length. • Blood in the vitreous may make it impossible to measure the axial eye length. • Keratometry may be erroneous in eyes that underwent keratorefractive surgery because such eyes may significantly deviate from spherical surfaces. • The user should make a visual check, when carrying out the measurement procedure, to ensure that all light spots are present. • If the appliance repeatedly generates error messages, stop using it and contact customer service. • You are recommended always to examine both the patient’s eyes. The user should subject the measurement readings to extra scrutiny if there is a notable difference between the right and left eye. The following are classed as notable differences: ◦ More than 1 dpt with respect to central corneal refractive power -> 0.18 mm difference with respect to the corneal curvature radius ◦ More than 0.3 mm with respect to axial eye length Wiki RevisionID: 39360

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Instruction Manual EyeSuite Biometry "3. Safety instructions" Doc. Nbr. : 1500 7220056 03021 Page :3/5

◦ More than 1 dpt with respect to emmetropic IOL refractive power • The user should check the A-scan when measuring anterior chamber depth in pseudophakic mode. If only one IOL signal is visible, it is not clear whether this signal relates to the front or back of the IOL. Uncertainty in this case can lead to the displayed reading for anterior chamber depth being inaccurate by the thickness of the IOL (approx. +/-1 mm). • An excessively tilted or decentered IOL may make it impossible to measure the anterior chamber depth and aqueous depth in pseudophakic eyes. • An intraocular pressure reading corrected on the basis of the measured corneal thickness does not in itself constitute a reliable diagnosis of glaucoma. • Ambient light has a bearing on pupil-diameter measurement readings. The user is responsible for ensuring the correct level of ambient light when carrying out pupillometry. The LS 900 cannot monitor ambient light, so do not use pupillometry as the decisive factor when considering keratorefractive surgery. • The white-to-white distance reading is merely an indirect measurement of the inner lateral dimensions of the anterior ocular section. It therefore provides only approximate indications of the actual inner lateral dimensions of the anterior ocular section and of the size of the implant used.

IOL calculation The measurements taken with the LENSTAR LS 900 are one central element of every IOL calculation. The other important part is the IOL constant used to calculate the power of an IOL to be implanted. Using LENSTAR, an optical non contact biometer, constants optimised for optical biometry should be used. Please contact the respective IOL Manufacturer to get information on optimised IOL constants for an individual set of lenses used. An alternative source for IOL constants optimised for optical Biometry is the homepage of the “User Group for Laser Interference Biometry” (ULIB) of the University of Wuerzburg, Germany. Even tough the constants published there have been optimised for a different optical Biometer than the LENSTAR LS 900, recently published, peer reviewed studies [1, 2, 3] indicate that ULIB published data can be used to calculate IOL power in connection with the LENSTAR LS 900. To further improve the outcome of the IOL calculation, it is recommended that every surgeon creates personalised IOL constants based on pre-operative data generated with the LENSTAR LS 900 and data from a stable refraction analysis at least 3 month post-operative.

References • [1] P J Buckhurst, J S Wolffsohn, S Shah, S A Naroo, L N Davies, E J Berrow, “A new optical low coherence reflectometry device for ocular biometry in cataract patients”, British Journal of Ophthalmology 2009;93:949-953 • [2] M P Holzer, M Mamusa, G U Auffarth, „Accuracy of a new partial coherence interferometry analyser for biométrie measurements”, British Journal of Ophthalmology 2009;93: 807-81 • [3] K Rohrer, B E Frueh, R Wälti, I A Clemetson, C Tappeiner, D Goldblum, “Comparison and Evaluation of Ocular Biometry Using a New Noncontact Optical Low-Coherence Reflectometer”, accepted for publication in Ophthalmology

IOL constants It is recommended to use personalised IOL constants to achieve maximum prediction accuracy of the IOL calculation. Using personalised IOL constants minimises the effects of individual surgical techniques, individual measurement- and surgical-equipment, ocular dimension and ethnic specialities of a patient population on the IOL calculation.

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Instruction Manual EyeSuite Biometry "3. Safety instructions" Doc. Nbr. : 1500 7220056 03021 Page :4/5

IOL constants derived using optical measurements If there are optimised or even personalised IOL constants available from a different optical biometer than the LENSTAR LS 900, they may be used as well with the LENSTAR LS 900 to achieve clinically identical results [1,2,3]. Optimised constants for optical biometers can also be found on the web site of the “User Group for Laser Interference Biometry” (ULIB) of the University of Wuerzburg, Germany.

IOL constants derived using immersion ultrasound measurements If there are optimised IOL constants available for immersion ultrasound, they may be used as a starting point for IOL Calculation with the LENSTAR LS 900. Still differences in IOL calculation may occur due to differences in the keratometry measurements of the LENSTAR LS 900 and the keratometer used in combination with the immersion ultrasound. A comprehensive manual how to convert existing ultrasound biometry optimised IOL constants to optical biometry optimised IOL constants can be found on the web site of the “User Group for Laser Interference Biometry” (ULIB) of the University of Wuerzburg, Germany. Still such converted data should only be used as a starting point to derive personalised constants.

IOL constants derived using contact ultrasound measurements If there are optimised constants available for a contact ultrasound biometer in combination with a keratometer, respective IOL constants have to be converted into constants optimised for optical biometry. A comprehensive manual how to convert existing ultrasound biometry optimised IOL constants to optical biometry optimised IOL constants can be found on the web site of the “User Group for Laser Interference Biometry” (ULIB) of the University of Wuerzburg, Germany. Still such converted data should only be used as a starting point to derive personalised constants.

Warranty and product liability • This product left our factory in a perfect state of repair. If an incident should occur however, please contact your dealer. • The manufacturer supplies the appliance with a warranty valid for two years from the date of purchase. The warranty does not cover malfunctions or defects arising from incorrect use or external factors. • Any attempt to carry out unauthorised repairs will immediately void all warranty liability. • Personal injury may result if the PC on which the EyeSuite biometry software is installed contains or runs other software that is likely to limit the functioning capabilities of EyeSuite. The manufacturer will accept no liability whatsoever in such cases. • Continued use of a product that has been damaged by incorrect operation can lead to personal injury. The manufacturer will accept no liability whatsoever in such cases. • Failure to follow the instructions in this manual will void all warranty claims. • Before unpacking the product, check the outside of the packaging for signs of incorrect handling and possible damage. If you do detect such damage, please notify the carrier responsible for delivery, and unpack the appliance in the presence of a representative of the transport firm concerned. You should then make out a report detailing any damage detected. The report should be signed by you and the carrier’s representative.

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Instruction Manual EyeSuite Biometry "3. Safety instructions" Doc. Nbr. : 1500 7220056 03021 Page :5/5

Statutory requirements • CE designation certifies the conformity of the LS 900 biometer’s software with European Directive 93/42 EEC (conformity module H). The software for the LS 900 makes it a class IIa device under the terms of this directive. • The software supplied on the CD-ROM conforms to European Directive 2002/95/EC (RoHS). • Haag-Streit can supply a copy of the European Declaration of Conformity for this product on request at any time. • The statutory accident-prevention regulations must be observed.

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Instruction Manual EyeSuite Biometry "4. General" Doc. Nbr. : 1500 7220056 04011 Page :1/2

4. General The EyeSuite biometer software used to control the LS 900 is supplied on a CD-ROM containing both the MySQL server software and EyeSuite Biometer.

Contents • 1 Minimum PC requirements ... 2 • 2 Data-storage requirement ... 2 ◦ 2.1 Example (private practice): ... 2 ◦ 2.2 Example (eye clinic):... 2

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Instruction Manual EyeSuite Biometry "4. General" Doc. Nbr. : 1500 7220056 04011 Page :2/2

Minimum PC requirements • • • • • •

Intel® Core™ 2 Duo 2.0GHz 2 GB memory (XP), 4 GB (Vista) 160 GB hard disk* CD-ROM / DVD USB2.0 interface (ICH5) Display 1280x800

Data-storage requirement The data-storage medium should conform to the expected use of the device. The volume of data handled can be calculated as follows: Standard measurement 1.8 Mbyte Measurement with basic screen image 2.7 Mbyte

Example (private practice): An average of 5 patients are measured on 250 working days. In the course of this, both eyes are each measured 5 times. Standard measurement 250 x 5 x 2 x 5 x 1.8 = 22.5 GB / year Measurement with red free (green light) image 250 x 5 x 2 x 5 x 2.7 = 33.8 GB / year

Example (eye clinic): An average of 20 patients are measured on 360 working days. In the course of this, both eyes are each measured 5 times. Standard measurement 360 x 20 x 2 x 5 x 1.8 = 130 GB / year Measurement with red free (green light) image 360 x 20 x 2 x 5 x 1.8 = 200 GB / year

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :1/8

5. Program Installation Preparation Please ensure that the LS 900 is not connected to the computer before the installation of the software.

Installation of EyeSuite Place the installation CD into the corresponding disk drive. Installation should begin automatically. If it does not, open the corresponding folder in Windows Explorer and double click on the file Install.exe to run it. Follow the on-screen instructions generated by the software.

Select your installation language. You may choose English, French and German. The PDF Copy of the user Manual is installed in the same language.

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :2/8

This version of EyeSuite is only working together with the EyeSuite versions specified in the screen

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :3/8

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :4/8

Select the applications you want to install. If you want to Install the Biometer application only, select Biometry only. if you want to install a pure viewing station, only select viewing. The MySQL Server has to be installt on the LENSTAR PC for stand alone applications or on the server only for network installations. For networkinstallations, please read the additional installation manual available on www.haag-streit.com

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :5/8

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :6/8

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :7/8

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Instruction Manual EyeSuite Biometry "5. Program Installation" Doc. Nbr. : 1500 7220056 05011 Page :8/8

EyeSuite has to restart to make shure installation is completed.

Installation of USB drivers 1. Once installation has been successfully completed, connect the device’s USB cable to the PC and switch on the power. 2. The operating system displays a message requesting installation of the device driver. In the dialogue, select: ◦ No, not this time and ◦ Install software automatically ◦ Click on "Continue installation" when the warning is displayed 3. Run the "EyeSuite" application from the Start menu, or double-click on the newly-created desktop icon.

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Instruction Manual EyeSuite Biometry "6. General program functions" Doc. Nbr. : 1500 7220056 06011 Page :1/84

6. General program functions Contents • 1 Settings ... 3 ◦ 1.1 General ... 3 ▪ 1.1.1 Predefined lists ... 3 ▪ 1.1.2 Data Backup ... 4 ▪ 1.1.3 Data archiving / compression ... 6 ▪ 1.1.4 Database ... 7 ▪ 1.1.5 User Management ... 8 ▪ 1.1.5.1 Change Password ... 9 ▪ 1.1.5.2 Add User... 10 ▪ 1.1.5.3 Delete User... 11 ▪ 1.1.6 Print page header ... 12 ▪ 1.1.7 EMR System... 13 ▪ 1.1.7.1 Communication in "text" format ... 14 ▪ 1.1.7.2 Example "text" file for calling-up of patient data for measurement ... 15 ▪ 1.1.7.3 Communication in "GDT" format ... 17 ▪ 1.1.7.4 "GDT" example file for calling-up of patient data for measurement... 17 ▪ 1.1.7.5 Return LENSTAR Data to EMR System... 18 • 2 Haag-Streit Script Language ... 20 ◦ 2.1 Use of the script language ... 20 ◦ 2.2 How it works ... 20 ▪ 2.2.1 Prefixes... 21 ▪ 2.2.2 Tags... 21 ▪ 2.2.3 Options ... 22 ◦ 2.3 Examples ... 22 ▪ 2.3.1 Example 1: XML EMR interface ... 22 ▪ 2.3.2 Example 2: XML Export of several measurements ... 24 ▪ 2.3.3 Example 3: CSV Export to Excel / OO-Calc or other spread sheet tools ... 25 • 3 Report writer ... 26 ◦ 3.1 Use of the report writer ... 26 • 4 Database backup and restore... 28 ◦ 4.1 Backup of the entire database ... 28 ◦ 4.2 Restoring a database... 31 • 5 Archiving / compression of data... 35 ◦ 5.1 Carrying out archiving / compression of data ... 35 ◦ 5.2 Recovery of archive data ... 39 • 6 How to connect to 3rd party IOL calculation software ... 42 ◦ 6.1 Connection to Holladay IOL Consultant... 42 ▪ 6.1.1 EyeSuite settings for Holladay IOL Consultant... 42 ▪ 6.1.2 Settings in the Holladay IOL Consultant ... 43 ◦ 6.2 Connection to OKULIX ... 49 ▪ 6.2.1 EyeSuite settings for OKULIX ... 49 ▪ 6.2.2 EyeSuite and OKULIX, how it works ... 50 ◦ 6.3 Connection to PhacoOptics ... 52 ▪ 6.3.1 EyeSuite settings for PhacoOptics Programs... 52 ▪ 6.3.2 EyeSuite and PhacoOptics, how it works ... 53 ◦ 6.4 Connection to Hoffer Programs ... 55 ▪ 6.4.1 EyeSuite settings for Hoffer Programs ... 55 ▪ 6.4.2 EyeSuite and Hoffer Programs, how it works ... 56

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Instruction Manual EyeSuite Biometry "6. General program functions" Doc. Nbr. : 1500 7220056 06011 Page :2/84

• 7 How to network EyeSuite... 58 ◦ 7.1 Installation and configuration of MySQL on the server machine ... 58 ▪ 7.1.1 Installation of the MySQL Server ... 58 ▪ 7.1.2 Configuration of the MySQL Server... 63 ◦ 7.2 Configuring the database and user account to user MySQL in a Network ... 69 ▪ 7.2.1 Installation of MySQL administrative tools... 69 ▪ 7.2.2 Configuring the database ... 71 ▪ 7.2.3 Creating a user account for networking with MySQL ... 75 ▪ 7.2.4 MySQL start variables ... 79 ◦ 7.3 Non standard procedure for network administrators... 81 ▪ 7.3.1 Automated backup on a server... 81 ▪ 7.3.2 Restore on a server ... 82 ◦ 7.4 Configuring EyeSuite to use a Network Database... 83

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