LENSTAR LS900 Instructions for Use Aug 2011

4.3.1 A-Scan... 21 4.3.2 Keratometry... 21 4.3.3 White-to-white distance... 23 4.3.4 Pupillometry and visual axis... 23 5 Software guide... 23 6 Care and maintenance... 23 6.1 Function check... 23 6.2 Cleaning... 25 7 Appendix... 25

1 SAFETY INSTRUCTIONS 1.1 General Points • The appliance must only be used for the purpose described in this operating manual. • Installation should only be carried out by trained technical personnel. • The device must not be stored or operated outside the prescribed ambient conditions (see section 7.1.5) • If the device is brought from a cold environment into the operating environment, condensation may form on cold surfaces. Wait a couple of hours until the device temperature has equalized and it is dry, before switching the device on. • Please carefully retain packing material for reuse in case of return delivery or removal to another location. • 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. • The doctor or operator undertakes to give the patient those safety instructions that concern him/her, and to monitor for their compliance. • Do not use the device in areas where there is a risk of explosion. Do not store volatile solvents (alcohol, petrol, etc.) or flammable narcotics in the vicinity. • Always remove the dust cover before switching on the device. Otherwise, the light sources may be destroyed by overheating. After use, ensure that the device is switched off before replacing the cover. • The removal of housing parts and repairs should only be undertaken by appropriately trained and authorized specialist staff. Improper repairs may result in considerable risk to operator and patient. • Only original spare parts and accessories may be used for repairs. • If exposed to the effects of an external force (e.g. by being accidentally knocked or dropped), this type of sensitive measuring device must be promptly checked according to section 6.1 (Function check) and, if necessary, returned to the factory for repair. • The manufacturer of this device is not liable for loss or damage due to its unauthorized handling. All consequent guarantee claims become invalid. • 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. • 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. • 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 1500.7220055.04030





© Haag-Streit AG, CH-3098 Koeniz, Switzerland

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. • Execute function checks when prompted by software (measurement properties, side recognition) • Shut down the computer whenever the system is to be out of use for an extended period. 1.2 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 - More than 1 dpt with respect to emmetropic IOL refractive po wer • 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 ambi-

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ent 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. 1.3 IOL calculation The measurements taken with the 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 the LS 900®, 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 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 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 LS 900® and data from a stable refraction analysis at least 3 month post-operative. 1.3.1 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 biometry measurements”, British Journal of Ophthalmology 2009;93: 807-810 [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 1.4 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 dimensions and ethnic specialities of a patient population on the IOL calculation.



1.4.1 IOL constants derived using optical measurements If there are optimised or even personalised IOL constants available from a different optical biometer than the LS 900®, they may be used as well with the 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.



1.4.2 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 LS 900®. Still differences in IOL calculation may occur due to differences in the keratometry measurements of the 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 Inter-

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ference Biometry” (ULIB) of the University of Wuerzburg, Germany. Still such converted data should only be used as a starting point to derive personalised constants. 1.4.3 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 shou only be used as a starting point to derive personalised constants. 1.5 Electrical connections • Only use a Haag-Streit approved external medical power supply (IEC/EN60601-1, UL60601-1, CAN/CSA C22.2 No 601.1-M90). • Plug, cable and earth-wire connection on socket must function perfectly. • Make sure that the device is only connected to power sources as defined on the device nameplate. This unit has no ON/OFF switch. Before carrying out maintenance or cleaning work, the device must always be disconnected from the mains by unplugging the DC connector. • Computers and other peripherals (printers, etc.) must meet standard IEC/EN 60601-1, or be connected via electrical isolation to external networks (isolating transformer, Ethernet isolator, etc.) • For connection to PC, only use the supplied USB cable (2 m). 1.6 Optical radiation According to IEC 60825-1, the limiting values for class 1 lasers are respected when the device is used in the defined manner. 1.7 Device transportation Use original packaging when transporting the device over long distances. For short distances, grasp the lower part of the device with both hands and lift (see section 3.3.1) 1.8 Special notes in text Additional safety instructions have been inserted in the text of this User Guide where necessary. They are differentiated according to their importance and are intended to help exclude any risk to patients or operators, to prevent damage to the biometer, and to guarantee perfect functioning of the device.

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1.9 Pictograms a) BEWARE! Instruction that must be followed to exclude risk to the patient or operator.. b) CAUTION! Instruction that must be followed to prevent damage to the biometer. c) TIP! Reminder that the mains connector should always be pulled out before the device is opened. 1.10 Device nameplate d) DC Power e) HS-Part number f) Type B equipment g) Date of manufacture h) Manufacturer i) Serial number j) Read User Guide carefully k) Disposal remark

a

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b

c

d

1.11 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 manufacturer 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. 1.12 Statutory regulations • 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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e

f

h

i

g

j

k

Entsorgung • Elektro- und Elektronikgeräte müssen getrennt vom Hausabfall entsorgt werden! Dieses Gerät wurde nach dem 13.07.2005 in Verkehr gebracht. • Entsorgung über die lokale Sammelstelle oder über Ihren Haag-Streit Vertreter. • Damit ist gewährleistet, dass keine schädlichen Stoffe in die Umwelt gelangen und wertvolle Rohstoffe wieder Verwendung finden. Environement • Les appareils électriques et électroniques doivent être éliminés séparément des déchets ménagers ! Cet appareil a été mis en circulation après le 13/08/2005. • Élimination par le biais du point de collecte local ou de votre représentant Haag-Streit. • Cela garantit que les matières polluantes ne sont pas disséminées dans l’environnement et que les matières premières précieuses sont recyclées. Environment • Electrical and electronic devices must be disposed of separately from domestic waste. This device came into circulation after 13.07.2005. • Disposal must take place via a local collection point or through your Haag-Streit agent. • This is to ensure that no harmful substances enter the environment and that valuable raw materials will be reused.

© Haag-Streit AG, CH-3098 Koeniz, Switzerland

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2 INTRODUCTION

2.1 Basic construction The system is divided into two parts: one concerned with examination (LS 900®) and the other with control (Notebook, PC). The examination part communicates via a USB connection with the external PC. The LS 900® is operated through software installed on the PC. Integral, automatic error recognition for measurements guarantees reliable examination results. New PC and biometrics software can be downloaded or updated from internet via the homepage. 2.2 Examination components (LS 900®) Overview 1 Front ring 2 Housing 3 Service cover 4 Cable cover 5 Joystick 6 Cross slide 7 Side identification sticker 8 Headrest 9 Forehead band 10 Auxiliary marking optimal eye height 11 Chin rest 12 Chin rest height adjustment 13 Hand grips for patient

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Device state The device state indicator allows device monitoring without PC software: 14 State indicator

Joystick The joystick is used to position the device in relation to the patient’s eye. 15 Trigger Connections 16 USB – device connection 17 DC – device connection 18 USB2.0 cable 19 DC cable 20 Tension compensator 2.3 Control component (PC) A commercial PC is used as the control component for the biometer. Control software runs under WINDOWS XP. 2.3.1 Minimum PC requirements • Intel CoreTM 2 Duo 2.0GHz • RAM: 2GB (XP), 4GB (VISTA) • 160GB Harddisk • CD-ROM / DVD • USB2.0 Schnittstelle (ICH5) 2.3.2 Minimum monitor requirements • 1280x800 pixel 2.4 Instrument table An adjustable instrument table (option) allows the height of the device to be set comfortably to the height of the individual patient. 21 Table top 22 Left-hand drawer (for external medical power supply) / Switchbox SB01 23 Right-hand drawer (empty) 24 Elevator column (mechanical with spring) 25 Pedestal with castors

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3 INSTALLATION 3.1 Safe system configuration according to IEC / EN 60601-1 BEWARE All externally connected devices must meet the relevant safety standards. 26 Power supply (LS 900®) 27 Instrument Table 28 Isolation Transformer 29 Laptop / PC 30 Power supply (PC) 31 Printer

LAN

3.2 Instrument table The instrument table is delivered in a separate package. To assemble table, please use instructions enclosed with it. 3.2.1 Mounting the roller rails/slide plate The roller rails/slide plate must be positioned in such a way that, when the device is centred, the patient’s eye will be at a distance of 68mm from the front of the device. 32 Rail 33 Positionning sticker 34 Gliding plate 35 Headrest columns 36 Aperture for cables

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3.2.2 Mounting the sticker for automatic position recognition • Take off rail cover and move the device to the side, if already in position. • Clean surface of table. • Remove protective film (Figure 37) from back of sticker. Start lifting it off carefully from the corner opposite the white area . • Position the sticker with the white side against the right roller rail (38) and the edge of the table (Figure 39). Press the black/white area down firmly and stroke out any air bubbles. • Carefully tear off the rest of the sticker (Positionierungswerkzeug/ Positioning Tool) along perforations (Figure 40).

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3.3 Mounting the device 3.3.1 Lifting the device To lift or reposition the device (short distances only): a) Grasp device from behind with one hand on the column and lift (Figure 41). b) With the second hand, support under the cross-slide (Figure 42).

3.3.2 Wiring cable under the device The device can be invisibly wired by passing cables through the cross-slide and using the cable channel underneath. To do this, you need either the Haag-Streit instrument table HSM901 with table-top biometer, or an aperture in the table-top used. • Remove cable cover (Figure 43) • Expose USB and supply cables (table aperture, Figure 44) • Push supply cable through aperture in base of cross-slide until the cable emerges from the upper front aperture (Figure 45) • Push USB cable through the same aperture in the cross-slide (Figure 45) • Plug both cables into the corresponding boxes and fix with the tension compensator (Figure 46) • Replace cable cover (Figure 47)

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3.3.3 Device connection, cables at side (Option) • Remove cable cover (Figure 48) • Expose USB and supply cables (left or right aperture on rail cover) • With a knife, cut towards the snap-off point provided on the left or right of the cable cover (Figure 49) • Carefully use fingers to snap off the cut part (Figure 50) • Insert both cables in the appropriate box and fix with the tension compensator. • Join both cables together with spiral cable and attach firmly using the cable channel on the rail cover (Figure 51) • Replace cable cover

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3.4 Computer connection • Connect the LS 900® to the PC with the enclosed USB2.0 cable. Use of the 2 m cable supplied with delivery is recommended.

BEWARE The USB cable should not exceed 5 m in length, otherwise impairment of device function must be expected.

• Insert mains cable. Integral mains components work with the voltages specified under section 7.1 'Technical data'. It is not necessary to select the voltage on the device. • If an instrument table has been supplied, the power supply of the LS 900® can beconnected to the Switchbox SB01 (left drawer). Use the manual enclosed to the switchbox and the instrument table. 3.4.1 Software Install software in accordance with separately described 'Software Installation'.

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4 OPERATION

4.1 Position of patient during measurement The positioning of the device is done manually by the user. The patient must be positioned in such a way that the distance from the measuring head to the eye is approx. 68 mm (Figure 52). A steady head position is promoted by resting the patient’s head well against the chin rest and forehead band, and by the patient holding on to the handles supplied. This can positively influence adjustment time and measuring accuracy. 4.2 Fixation To obtain usable results, the patient must stare at the red fixation light in the measuring lens during measurement. If the patient has difficulty seeing the fixation light with the eye being measured, this can be remedied by fixing the other eye on an opposed remote object. To carry out peripheral measurement of corneal thickness, 32 green fixation points are provided. These can be switched on or off by software. The points are arranged in 2 rings. When the patient stares at these points (Figure 53), a peripheral zone is measured with the following distances (a) from the horizontal axis (standard eye R = 7.8 mm): 2.7 mm Outer distance: Inner distance: 2 mm b: Fixation periphery c: Eye d: Fixation center (Measurement beam, red)

4.3 Measured variables 4.3.1 A-Scan Depending on the patient’s gaze at the fixation light, the optical path length of the visual axis is measured. (Figure 54) CT: Corneal thickness AD: Aqueous depth (back of cornea to front of lens) LT: Lens thickness AL: Eye length (front of cornea to retinal peak) Note: Depending on the chosen software mode, eye length is indicated to the inner limiting membrane (retinal pigment epithelium – 0.2 mm).

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4.3.2 Keratometry Keratometry is calculated through the position of 32 projected light reflections. Sixteen measuring points on each eye are arranged in two rings with the following diameters (standard eye R = 7.8 mm): Outer measuring points: 2.3 mm Inner measuring points: 1.65 mm For each measuring point, the equivalent of an ideal sphere is calculated. The values displayed (flat radius, steep radius) correspond to the radii of an ellipsoid that fits into the assemblage of points. The axis of its rotation is measured counter-clockwise from the horizontal to the flat radius. (Figure 54) e: Flat radius f: Steep radius g: Axis of its rotation

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4.3.3 White-to-white distance The white-to-white distance (WW) is determined using the image of the iris and the eye radii obtained from keratometry. The value displayed corresponds to the diameter of an ideal circle. (Figure 56) 4.3.4 Pupillometry and visual axis Pupil diameter (Ø) corresponds to the diameter of an ideal circle, with the smallest error square to the established pupil border. At the same time, the shift of visual axis towards the centre of the pupil is provided. The calculated dimensions are located on the theoretically derived level of the iris. Image enlargement achieved by breaking up the eye is disregarded. (Figure 57)

5 SOFTWARE GUIDE Device operation for carrying out an examination is set out in a separate guide, together with a description of EyeSuiteTM application software

6 CARE AND MAINTENANCE BEWARE

• Biometer housing parts should only be removed by trained personnel. • The ON/OFF switch does not disconnect the biometer from the mains. Before removing housing parts, the device must always be disconnected from mains power by unplugging the mains power cable. • Repairs should only be undertaken by suitably trained, authorized, technical staff. Improper repairs may result in considerable risk to patient and operator. • If parts must be replaced, only original spare parts supplied by HAAG-STREIT or its agent should be used. • Guarantee claims cannot be enforced if instructions in the User Guide have been ignored.

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The LS 900® is practically maintenance free and only requires minimal care to provide complete satisfaction over a long working life. However, we recommend instructing a service engineer to overhaul the biometer periodically. HAAG-STREIT or your local agent will be happy to provide further information. 6.1 Function check The inspection gauge (Figure 58) supplied with the device will assist the user in checking the proper functioning of the unit. This check takes place for the first time when the device is commissioned. Subsequent test intervals (1 week) will be specified by the software (message displayed). For exact procedure see software guide.

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If test results fall outside tolerances, a corresponding message will be displayed and the device should be taken out of service. Please inform Haag-Streit Service.

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6.2 Cleaning Regular dusting of the device with a soft cloth is sufficient. More stubborn dirt can be removed using a soft, non-runoff cloth dampened with water or alcohol at maximum 70%.

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CAUTION

Avoid making the device wet and use only the means listed above. Under no circumstances use solvent or any other abrasive methods.

The accessories of the LS 900® include a dust cover. Cover the device when cleaning work is in progress, or if the devices is not in use for long periods. Before switching the device on, the dust cover must be removed.

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CAUTION CAUTION

The not bewet covered whennoitscircumstances state is switched Avoiddevice makingmust the device and under use on (heatordam, risk). solvent any fire other abrasive methods.

7 APPENDIX

7.1 Technical data Manufacturer HAAG-STREIT AG Gartenstadtstrasse 10 CH-3098 Köniz / Switzerland 7.1.1 General Type designation: LS 900® Dimensions (W x D x H): 310 x 260 x 420 mm Weight: 6.2 kg 7.1.2 Electrical data 7.1.2.1 Power supply (primary side) Power supply: Compliant EN / IEC60601-1 HS-Nr.:1020392, Friwo FW7401M/12 7.1.2.2 Device (secondary side) Voltage: 12 V Power draw: 12 W

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7.1.3 Optical radiation 7.1.3.1 Eye length measurement (A-Scan) and central fixation Light source: Superlum. diode Wave length: 820nm Power on patient’s eye: < 0.6 mW max. exposure per patient/day: 30 000 s 7.1.3.2 Keratometry Light source: LED Wave length: 950nm Power on patient’s eye: < 0.2 mW max. exposure per patient/day: 30 000 s 7.1.3.3 Peripheral fixation Light source: LED Wave length: 570 nm Power on patient’s eye: < 0.02 mW max. exposure per patient/day: 30 000 s 7.1.3.4 Green illumination Light source: LED Wave length: 525 nm Power on patient’s eye: < 0.2 mW max. exposure per patient/day: 600 s The combination of radiation generated corresponds to laser class I,

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according to IEC 60825-1. 7.1.4 Measured variables Measurement ranges are based on the standard setting of the device for automatic measurements and analysis ('Phakic' measurement mode). Repeatability was determined by statistical analysis of variance (ANOVA) of repeated measurements. The method permitted separation of systematic influences like subject or eye (within subject) and effects of random error (residuals). Repeatability (denoted as SDrepeat in Tab. 1 and 2) was calculated as square root of the residual error. 7.1.4.1 Corneal thickness (CT) Measurement range: 300 – 800 μm Display resolution: 1 μm In-vivo repeatability (1.SD): ±2.3 µm 7.1.4.2 Anterior chamber depth (ACD) Measurement range: 1.5 - 5.5 mm Display resolution: 0.01mm In-vivo repeatability (1.SD): ±0.04 mm 7.1.4.3 Lens thickness (LT) Measurement range: 0.5 – 6.5 mm Display resolution: 0.01 mm In-vivo repeatability (1.SD): ±0.08 mm 7.1.4.4 Eye length (AL) Measurement range: 14 – 32 mm Display resolution: 0.01 mm In-vivo repeatability (1.SD): ±0.035 mm 7.1.4.5 Keratometry (R) Measurement range for radius: 5 – 10.5 mm Display resolution: 0.01 mm In-vivo repeatability (1.SD): ±0.03 mm Measurement range for axis angle: 0-180° Display resolution: 1° In-vivo repeatability (1.SD): ±11° 7.1.4.6 White-to-white distance (WTW) Measurement range: 7 - 16 mm Display resolution: 0.01 mm In-vivo repeatability (1.SD): ±0.04 mm 7.1.4.7 Pupillometry Measurement range : 2 – 13 mm Display resolution: 0.01 m Data for subjects with a complete set of 5 repeat measurements for both eyes were included to derive Mean grand , SDrepeat and the coefficient of variation (CV) shown in Tab. 1 and 2. For each measurement parameter the standard deviations of each set of 5 replicate measurements were found to be nearly constant over the range of mean results. This finding confirms that the indication of one single standard deviation value for each measurement parameter is a valid approach. 7.1.4.8 Data source In-vivo repeatabilities (1.SD) have been derived from data of a clinical study. This study was designed and accomplished as a prospective, non-randomized single site comparison study. The approved investigational plan included in study stage 1 measurements of axial length (AL), central corneal thickness (CT), anterior chamber depth (ACD), central lens thickness (LT), mean corneal radius (R), and axis of the flat meridian. In study stage 2 the whiteto-white distance was measured. A total of 144 eyes of 80 subjects were included in study stage 1 and a total of 40 eyes of 20 subjects in study stage 2. Subjects with different conditions of the anterior and posterior segment of the eye (cataract in different stages, pseudophakia with different IOLs, aphakia, silicone-oil fill) and healthy eyes were included in this clinical study. Data were analyzed for all eyes (see Tab. 1) and a subgroup of special eyes (see Tab. 2) with a complete set of 5 repeat measurements on both eyes of each subject. The special eyes group included eyes with one or more of the following conditions: pseudophakia, aphakia and silicone-oil fill.

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Tab. 1: Alle Augen / Tous les yeux / All Eyes [unit]

n

Meangrand

SDrepeat

CV

AL [mm]

45 / 90

23.973

0.035

0.00145

CT [µm]

53 / 106

557.1

2.3

0.00407

ACD [mm]

34 / 68

3.19

0.04

0.01220

LT [mm]

27 / 54

4.56

0.08

0.01784

R [mm]

34 / 68

7.67

0.03

0.00396

Axis [°]

27 / 54

72

11

0.14191

WTW [mm]

9 / 18

12.27

0.04

0.00337

Tab. 2: Spezielle Augen / Yeux spéciaux / Special Eyes [unit]

n

Meangrand

SDrepeat

CV

AL [mm]

10 / 20

24.087

0.056

0.00234

CT [µm]

11 / 22

564.4

2.8

0.00496

R [mm]

5 / 10

7.75

0.03

0.00333

Axis [°]

3/6

80

13

0.16092

n:

Anzahl der Probanden oder Augen Meangrand: Mittlerer Wert aller Ergebnisse aller Augen SDrepeat: Wiederholte Standardabweichung CV: Variationskoeffizient SD: Standardabweichung

AL: Axiale Länge CT: Hornhautdicke ACD: Vorderkammertiefe LT: Linsendicke R: Hornhaut-Krümmungsradius Axis: Achse des flachen Meridian WTW: Weiss-Weiss-Abstand

n:

Nombre de sujets ou des yeux Meangrand: Valeur moyenne de tous les résultats de tous les yeux SDrepeat: Écart standard répété CV: Coefficient de variation SD: Écart standard

AL: Longueur axiale CT: Épaisseur de la cornée ACD: Profondeur de la chambre antérieure LT: Épaisseur de la lentille R: Rayon de courbure de la cornée Axis: Axe du méridien plat WTW: Écart blanc-blanc

n:

AL: Axial length CT: Corneal thickness ACD: Anterior chamber depth LT: Lens thickness R: Corneal radius of curvature Axis: Axis of flat meridian WTW: White-to-white distance

Number of subjects / number of eyes Meangrand: Overall mean of all replicate measurements results on all eyes SDrepeat: Square root of the residual error (Repeatability standard deviation) CV: Coefficient of variation SD: Standard deviation

© Haag-Streit AG, CH-3098 Koeniz, Switzerland

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7.1.5 Ambient conditions 7.1.5.1 Use Temperature: +10°C to +35°C Relative humidity: 30% to 75% Air pressure: 800hPa to 1060hPa 7.1.5.2 Storage Temperature: -10°C to +55°C Relative humidity: 10% to 95% Air pressure: 700hPa to 1060hPa 7.1.5.3 Transport Temperature: -40°C to +75°C Relative humidity: 10% to 95% Air pressure: 500hPa to 1060hPa 7.1.6 Classification/safety regulations IEC / EN 60601-1: Biometer LS 900® according to protection class II Type B application part Operating mode: permanent operation IEC / EN 60601-1-2: EMC IEC 60825-1: Laser class I 93/42 EEC (medical products): Class IIa FDA: Class II EMC: The LS 900® complies with the standard IEC / EN 60601-1-2. The device is designed to avoid generation and emission of electromagnetic interference to other devices in its proximity and is stable against electromagnetic interference form other devices. 7.1.7 Compliance with standards IEC / EN 60601-1:1990 +A1:93 +A2:95 (ed.2) IEC / EN 60601-1-2:2001 EN ISO 15004-1:2006 IEC 60825-1:2001 EN ISO 10343: 1999 7.1.8 RoHS-China Environmentally friendly use period (EFUP) Formula for a product which could be repaired: 125% = Coefficient for repairable products. Daily working life = came from the field tests. Average daily working life: 1825 patients per Year and 5 minutes per patient.

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Technical Life: ~2500 hours

The Environmentally Friendly Use Period (EFUP) is of approx.20 Years.

33 PRODUCT IS CERTIFIED FOR BOTH THE U.S. AND THE CANADIAN MARKETS, TO THE APPLICABLE U.S. AND CANADIAN STANDARDS.

1250

1500.7220055.04030

Haag-Streit AG Gartenstadtstrasse 10 CH-3098 Koeniz, Switzerland Phone ++ 41 31 978 01 11 Fax ++ 41 31 978 02 82 eMail [email protected] internet www.haag-streit.com

© Haag-Streit AG, CH-3098 Koeniz, Switzerland

Notizen / Notices / Notes

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© Haag-Streit AG, CH-3098 Koeniz, Switzerland

1500.7220055.04030

Notizen / Notices / Notes

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1500.7220055.04030

© Haag-Streit AG, CH-3098 Koeniz, Switzerland