User Manual - Haag
Contents
1. gt n m T 2 med approved EN 60601 1 10 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 10 09 04 2014 09 47 38 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 e Remove protective film 44 from back of the sticker Start lifting it off carefully from 44 the corner opposite the white area Position the sticker with the white side against the left roller rail 44 and the 45 edge of the table 46 Press the black white area down firmly and stroke out any 46 air bubbles e Carefully tear off the rest of the sticker 47 Positioning Tool along the perfo rations Check whether the position recognition function in the software works correctly 3 3 Transporting the device Transport the device over longer distances in its original packaging WARNING In its original packaging the device can withstand the transport condi tions as per EN ISO 15004 1 For short distances grasp the device by the base and lift 48 then support the cross slides with your second hand 49 i HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 11 3 3 1 Device connection cables under the device The device can be2. A total of 144 eyes in 80 subjects were included in study phase 1 and a total of 40 eyes in 20 subjects in study phase 2 e Subjects with different conditions of the anterior and posterior segment of the eye cat aract in different stages pseudophakia with different IOLs aphakia silicone oil fill and subjects with healthy eyes were included in this clinical study Data were analyzed for all eyes see Tab 1 and for a subgroup of eyes with special health conditions 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 01 IFU_LS900 7220055 04070_eng indd 16 unit n Meangrand SDrepeat cV AL mm 45 90 23 973 0 035 0 00145 CCT um 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 1 0 14191 WTW mm 9 18 12 27 0 04 0 00337 Tab 2 Special Eyes unit n Meangrand SDrepeat cV AL mm 10 20 24 087 0 056 0 00234 CCT um 11 22 564 4 2 8 0 00496 ACD mm 5 10 7 75 0 03 0 00333 Axis 3 6 80 13 0 16092 Abbreviations n Number of subjects number of eyes Meangrand Overall mean of results on all eyes SDrepeat Repeatability standard deviation cV Coefficient of variation SD Standard deviation LT Lens thickness AL Axial length R Corneal radius of curvature CCT Central corneal thickness A
3. 025 12 Sphere 2 mm 5 S R 7 804 0 008 0 034 0 33 0 008 0 026 0 75 Sphere 3 mm E R 8 844 0 017 0 056 0 46 0 024 0 038 1 61 Sphere 4 mm 2 7 R 10 501 0 040 0 082 0 48 0 069 0 044 0 58 01 IFU_LS900 7220055 04070_eng indd 17 Sphere 1 011 5 mm Toric ellipsoid sphere 2 3 4 14 mm All surfaces Precision lt 1 um Test surfaces were centred within 0 1 mm and their symmetry axes aligned within 0 5 with regard to their measuring axis 6 4 3 Reproducibility Human cornea axial curvature difference D elevation difference um Central Zone Diameter lt 3 mm Middle zone 3 lt Diameter lt 6 mm Mean value 1 st dev 2 st dev Mean value 1 st dev 2 st dev 0 001 0 38 0 66 0 76 1 31 0 020 0 36 3 22 0 72 6 45 n 42 eyes 7 Software Help menu Error messages The software s help section contains instructions and help for performing an exam ination and descriptions of the error messages The help can be opened via the F1 key or in the Help menu WARNING The software must be installed by trained personnel in accordance with the separate installation instructions 8 Maintenance The LS 900 is practically maintenance free and requires only minimum care to work for as long as possible to your complete satisfaction However we recommend in structing a service engineer to inspect the biometer periodically HAAG STREIT or your local agent will be happy to provide further informa
4. 5 GHz Nominal output of the transmitter W D 1 2 P D 1 2 P D 23 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 12 23 10 3 8 3 8 7 3 100 12 12 23 For transmitters with a nominal output not listed in the table above the distance D can be calculated in meters m using the equation for the respective column in which P is the nominal output of the transmitter in watts W according to the specifications of the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the higher frequency applies NOTE 2 To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2 5 GHz an additional factor of was used to reduce the probability of a mobile portable communication device causing interference if inadvertently brought into the patient area NOTE 3 These guidelines may not apply in all situations Electromagnetic wave propagation is influenced by absorption and reflection of buildings objects and people HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 23 01 IFU_LS900 7220055 04070_eng indd 23 09 04 2014 09 47 45 Should you have any further questions please contact your HAAG STREIT dealer at http www haag streit com contact contact your distributor html ea HAAG STREIT DIAGNOSTICS PRODUCTS CERTIFIED FOR BOTH THE U S lt P AND CANADIAN MARKETS TO THE APPLI us CABLE U S AND CANADIAN STANDARDS Certified Quality Management System H
5. cannot monitor ambient light so do not use pupillometry as the decisive factor when considering kera torefractive surgery Keratometry may not be accurate in eyes with keratoconus and so the user must verify its plausibility The user must verify that the eye assignment OD OS is correct for the measured eye 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 dimen sions of the anterior ocular section and of the size of the implant used The measured results of patients with asteroid hyalosis may not be accu rate in particular the axial length measurement and must therefore be verified by the user in terms of their plausibility If the optional T Cone is used the user should verify the even illumina tion of the cone 01 IFU_LS900 7220055 04070_eng indd 6 1 6 2 IOL calculation The measurements taken with the LS 900 are a central element of every IOL cal culation A further important parameter in calculating the lens to be implanted is the IOL constant When using the Lenstar LS 900 only IOL constants optimised for optical biometers should be used Please contact your IOL manufacturer for infor mation on optimised IOL constants for optical biometry An alternative source of information for IOL constants optimised for optical biometry is the website of the Us
6. directly connected to Emission of harmonics Class A the public low voltage power supply network that supplies buildings used for domestic purposes according to EN 61000 3 2 20 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 20 09 04 2014 09 47 44 F 3 Immunity standard table 2 Guidance and manufacturer s declaration electromagnetic immunity This product is intended for use in the electromagnetic environment specified below The customer or the user of this product should assure that it is used in such an envi ronment Immunity test standard Electrostatic discharge ESD EN 61000 4 2 Electrical fast transient burst EN 61000 4 4 Surge EN 61000 4 5 Voltage dips short interruptions and voltage variations on power supply lines EN 61000 4 11 Power frequency 50 60Hz magnetic field EN 61000 4 8 EN 60601 test level 6 kV contact 8kV air 2 kV for power supply lines 1 kV for symmetrical voltages 2 kV for asymmetrical voltages lt 5 U gt 95 drop in U for cycle lt 40 U gt 60 drop in U for 5 cycles lt 70 U gt 30 drop in U for 25 cycles lt 5 U gt 95 drop in U for 5s 3A m NOTE U the AC mains voltage prior to application of the test level Compliance level 6 kV contact 8kKV air 2 kV for power supply lines 1 kV for symmetrical voltages 2 kV for asymm
7. envi ronment Electromagnetic environment guidance Portable and mobile RF communications equipments hould be used no closer to any part of this product including cables than the recommended separation distance cal culated from the equation applicable to the frequency of the transmitter Immunity test standard EN 60601 test level Compliance level Recommended distance Conducted RF EN 61000 4 6 3 Vms 3 Vms D 12 VP 150 kHz 80 MHz Radiated RF EN 61000 4 3 3 Vim 3 V m D 1 2 P 80 MHz 800 MHz 80 MHz 2 5 GHz 80 MHz 800 MHz D 2 3 P 800 MHz 2 5 GHz distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At80 MHz and 800 MHz the higher frequency 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 for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broad cast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in
8. which this product is used exceeds the applicable RF compliance level above this product should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating this product b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m c Possible shorter distances outside the ISM bands do not contribute to improved application in this table Where P is the maximum output power rating of thet ransmitter in watts W according to the transmitter manufacturer and D is the recommended separation e 22 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 22 09 04 2014 09 47 44 F 4 Safe distances on non life support devices standard table 6 Recommended safe distances between portable and mobile HF communication devices and this device This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled The customer or user of this product can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems transmitters and this product as rec ommended below in accordance with the maximum output of the communication system Safe distance according to transmission frequency m 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2
9. with The manufacturer of the device is not liable for loss or damage due to un authorised handling of the same All warranty claims arising in this case are null and void Always remove the dust cover before switching the device on The light sources can be destroyed by overheating Likewise make sure that the device is switched off before attaching the dust cover e Repairs may only be conducted by suitably trained and authorised spe cialist personnel Incorrect repairs can pose considerable risks for operat ing staff and patients Only original spare parts and original accessories may be used for repairs The software must be installed by trained personnel 01 IFU_LS900 7220055 04070_eng indd 5 1 6 1 A The optional T Cone may only be used with the Lenstar The optional T Cone may only be used with Lenstar devices with a serial number of 2000 or Lenstar devices converted to white light illumination The optional T Cone must be checked for damage before use The optional T Cone must not be exposed to strong direct sunlight Plausibility of the measurements WARNING Users must check measurement readings for plausibility This includes the checking of the A scan and the cursors which automatically adjust to the signal the keratometry values the white to white distance and the pupillometry whenever one of the measurements displays an unusual ly high standard deviation The operator must als
10. 01 IFU_LS900 7220055 04070_eng indd 1 LENSTAR C A INSTRUCTION MANUAL Biometer Lenstar LS 900 7 edition 2014 01 Paes HAAG STREIT DIAGNOSTICS 09 04 2014 09 47 31 INSTRUCTION MANUAL Contents Biometer 1 Safety ti Areas of application of the device Lenstar LS 900 14 2 Patient population 1 3 Ambient conditions 1 4 Shipment and unpacking 7 Edition 2014 01 1 5 Installation warnings 1 6 Operation environment 1 6 14 Plausibility of the measurements Introduction 1 6 2 IOL calculation r x E 1 6 3 Referenci Thank you for choosing a HAAG STREIT device Provided you comply careful 16 4 IOL cons ly with the regulations in these instructions for use we can guarantee reliable and 1 6 5 IOL constants derived using data from an immersion trouble free use of our product iilira sound DOMEEN sesine aia 7 I 1 6 6 IOL constants derived from data from a contact WARNING a NS o a 1 RIPERT EEA PE A EAE TE OANE A ETEEN 7 Read the instruction manual carefully before commissioning this pro 1 7 Optical radiation i duct It contains important information regarding the safety of the user 1 8 Disinfection and patient 1 9 Warranty and product liability P S 1 10 Symbols NOTE 2 Introduction Federal law restricts this device to sale by or on the order of a physician 2 1 Basic construction i rr 2 2 Examination components LS 900 or licensed practitioner 23 Control
11. 014 09 47 31 a D We recommend checking the calibration of the optional T Cone when fit ting it and repeating this if necessary see section Function check NOTE This device may only be used for the purpose described in these instruc tions for use Installation only by trained specialists The PC on which the EyeSuite software is installed may not contain any other software which could restrict the correct operation of EyeSuite Please switch the computer off if it is not to be used for a long time The device may not be transported stored or operated outside the speci fied ambient conditions see section Ambient conditions The device is to be used in a room in the medical area with attenuated light If exposed to the effects of an external force e g by being accidentally knocked or dropped this sensitive measuring device must be prompt ly checked according to section Function check and if necessary re turned to the factory for repair e If the device is moved transported a functional check must be performed in accordance with section Function check Perform a zero adjustment and function check when prompted by the software The selected measuring mode must be checked before every measure ment Keep these instructions for use in a place where they are accessible at all times to those working with the device Warranty claims can only be made if the instructions for use have been complied
12. AAG STREIT AG m Gartenstadtstrasse 10 O 1250 3098 Koeniz Switzerland EN 80 13485 Phone 41 31 978 01 11 Reg Nr 11956 Fax 41 31 978 02 82 eMail info haag streit com Internet www haag streit com 01 IFU_LS900 7220055 04070_eng indd 24 09 04 2014 09 47 45
13. HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 Operation Position of patient during measurement Measuring with the optional T Cone Fitting the optional T Cone Measuring with the T Cone Removing the optional T Cone Fixati Mea Keratometry White to white distance Pupillometry amp visual axis Commissioning Switching on the device 88 SWICHING Olt COVICE iaaa Technical data Power supply Primary side Secondary side llumination modalities Eye length measurement A Scan and central fixation Keratometry Illumination Positioning aid from serial number 2000 Measured variables Lenstar LS 900 Central corneal thickness CCT jais Anterior chamber depth ACD atO Lens thickness LT Axial length AL Keratometry R White to white distance WTW Pupillometry aiisseisirsssisitsssiasisss Study design a Technical data of T Cone option 17 Normative considerations 17 Measuring accuracy 17 Reproducibility 01 IFU_LS900 7220055 04070_eng indd 3 8 1 8 2 8 3 AA A1 1 A1 2 CA C 2 E F2 F3 F4 F4 Software Help menu Error messages Maintenance sississccscscesecsvsasssrarcserscascscssansosonsssvusesesdartasisectoee Function check zero adjustment CIS ANING RPR OAS PET AET ee Maintenance of T Cone Option 0 sesssescsssecssecssseecssecssseess
14. Temperature from 40 C to 70 C Air pressure from 500 hPa to 1060 hPa Relative humidity from 10 to 95 Storage Temperature from 10 C to 55 C Air pressure from 700 hPa to 1060 hPa Relative humidity from 10 to 95 Use Temperature from 10 C to 35 C Air pressure from 800 hPa to 1060 hPa Relative humidity from 30 to 90 1 4 Shipment and unpacking Before unpacking the device check whether the packaging shows traces of improper handling or damage If this is the case notify the transport company that delivered the goods to you Unpack the equipment together with a representative of the transport company Make a report of any damaged parts This report must be signed by you and by the representa tive of the transport company Leave the device in the packaging for a few hours before unpacking it condensation 01 IFU_LS900 7220055 04070_eng indd 4 Check the device for damage after it is unpacked e Return defective devices in the appropriate packaging Store packaging material carefully so that it can be used for possible returns or when moving e Check that the contents of the packaging correspond to the contents specified on the leaflet included in the packaging 1 5 Installation warnings WARNING e Only use a HAAG STREIT approved external medical power supply EN 60601 1 The plug cable and socket must function perfectly Before carrying out maintenance or cleaning work the device must
15. al ways be disconnected from the mains by unplugging the power supply or plug e Computers and further ancillary devices printers etc must comply with the EN 60601 1 standard or be connected with galvanic isolation to ex ternal networks isolating transformer galvanic Ethernet isolator etc see also Safe system configuration in accordance with EN 60601 1 For connection to PC use only the supplied USB cable 2 m The power supply must be positioned in such a way that proper heat dis persion is guaranteed 1 6 Operation environment DANGER e Itis expressly forbidden to open the device Never use the device in potentially explosive environments where volatile solvents alcohol benzine etc and combustible anaesthetics are in use WARNING The doctor or the operator is under an obligation to inform the patient about safety instructions concerning them and to ensure that these in structions are complied with Only staff trained and experienced in the assessment of measuring data and calculations and the manual entry editing and deletion of data may examine patients operate the device and interpret results All users must be appropriately trained and familiarised with the contents of the instructions for use especially with regard to the safety instructions contained therein e Measurements can be carried out with dilated or undilated pupils Dilation of the pupil only influences pupillometry 09 04 2
16. ay of points The axis of its rotation is measured count er clockwise from the horizontal to the flat radius 62 e Flat radius e f Steep radius e g Axis of rotation 4 4 3 White to white distance The white to white distance WTW is determined using the image of the iris and the eye radii obtained from keratometry The value displayed corresponds to the di ameter of an ideal circle 63 63 4 4 4 Pupillometry amp visual axis Pupil diameter corresponds to the diameter of an ideal circle with the smallest error perpendicular 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 The image enlargement achieved by the refraction of the eye is disregarded 64 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 09 04 2014 09 47 42 5 Commissioning Energy to the Lenstar LS 900 biometer is supplied by the medical power supply FRIWO 3288 DT12 12 HED HS no 1020392 5 1 Switching on the device e Connect the power supply up to the mains e Switch on the PC Start the software on the PC 5 2 Switching off the device Exit the software on the PC e Switch off the PC e Disconnect the Lenstar from the mains if you do not intend to use it for an extended period of time 6 Technical data Type desig
17. component PC 24 MStrUMENE PADIS O a Intended use The LS 900 is a non invasive non contact OLCR optical low coherence reflectom 3 Appliance assembly installation an 4 3 1 Safe system configuration according to EN 60601 1 etry biometer used for obtaining ocular measurements and performing calculations 3 2 Instrument table option assembly to assist in the determination of the appropriate power and type of IOL intraocular 3 2 1 Mounting the roller rails slide plate lens for implantation after removal of the natural crystalline lens The LS 900 mea 3 2 2 Mounting the sticker for automatic position sures 3 3 Transporting the device Axial eye length 3 3 1 Device connection cables under the device Corneal thickness 3 3 2 Device connection cables at side option e Anterior chamber depth So 5 3 5 installing a short forehead band when using the optional T Cone Aqueous depth e Lens thickness Corneal curvature e Radii for flat and steep meridian Axis of the flat meridian e White to white distance e Pupil diameter 2 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 2 09 04 2014 09 47 31 4 1 4 2 4 2 1 4 2 2 4 2 3 43 44 4 4 1 4 4 2 4 4 3 4 4 4 5 1 5 2 6 1 6 1 1 6 1 2 6 2 6 2 1 6 2 2 6 2 3 6 2 4 6 3 6 3 1 6 3 2 6 3 3 6 3 4 6 3 5 6 3 6 6 3 7 6 3 8 6 4 6 4 1 6 4 2 6 4 3
18. ctly The red safety mark is visible Please remove the T Cone and fit it again 01 IFU_LS900 7220055 04070_eng indd 13 WARNING The T Cone can only be used with the Lenstar with which it was calibrat ed To use the T Cone on another Lenstar or to use another T Cone on a Lenstar with an already saved T Cone calibration the calibration must be performed again The measuring distance from the T Cone to the eye apex is approx 6 mm Depending on the anatomy of the patient the tip of the T Cone may touch the eyelid or bridge of the nose To avoid injuries care must always be taken when moving the Lenstar with fitted T Cone towards the patient NOTE When you use the T Cone for the first time with the Lenstar LS 900 biom eter the software will prompt you to calibrate the T Cone with the Lenstar LS 900 biometer To do so follow the software wizard and read the soft ware operating instructions F1 key We recommend performing a test measurement every time the T Cone is fitted and removed The test measurement can be invoked in the soft ware s biometry menu To do so follow the software wizard and read the software operating instructions F1 key 4 2 2 Measuring with the T Cone Fit the T Cone as described in 4 2 1 Prior to every measurement procedure the tip of the T Cone should be cleaned with a lint free cloth soaked in 70 alcohol To do so use a moistened cotton bud or lint free cloth The cloth or c
19. e difference between the right and left eye The fol lowing are classed as notable differences 09 04 2014 09 47 32 N e More than 1 D with respect to central corneal refractive power gt 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 D with respect to emmetropic IOL refractive power The user must 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 Uncer tainty in this case can lead to the displayed reading for anterior chamber depth being inaccurate by the thickness of the IOL approx 1 mm The measured corneal thickness is not intended as a basis for the correc tion of intraocular pressure readings for diagnosing glaucoma An excessively tilted or decentered IOL may make it impossible to mea sure the anterior chamber depth lens thickness and aqueous depth Measurement readings obtained from patients with a non intact cornea e g due to a corneal transplant corneal opacity or corneal scarring etc may possibly be inaccurate this applies to keratometry in particu lar and the user should check the data for plausibility 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
20. er Group for Laser Interference Biometry ULIB at the University of Wuerz burg Germany Even though the constants published there have been optimised for a different optical biometer published data 1 2 3 indicate that these IOL con stants can also be used for calculating IOL power with the Lenstar Downloadable IOL Constants files for the Lenstar featuring the ULIB OL Constants for the Haigis Hoffer Q Halladay SRK T and SRK II Formulae as well as IOL Constants for the use with the Olsen Formula are available in the Key User section of the Haag Stre it homepage To further improve the clinical result HAAG STREIT recommends that every sur geon creates personally optimised IOL constants based on pre operative mea surement data generated with the Lenstar and reliable postoperative data e g 3 months after the operation 1 6 3 References 1 Buckhurst P J Wolffsohn J S Shah S Naroo S A Davies L N Berrow E J A new optical low coherence reflectometry device for ocular biometry in cataract pa tients British Journal of Ophthalmology 2009 93 949 953 2 Holzer M P Mamusa M Auffarth G U Accuracy of a new partial coherence interferometry analyser for biometric measurements British Journal of Ophthalmology 2009 93 807 810 3 Rohrer K Frueh B E Walti R Clemetson A Tappeiner C Goldblum D Com parison and Evaluation of Ocular Biometry Using a New Noncontact Optical Low Coherence Reflectometer Ophtha
21. etrical voltages lt 5 U gt 95 drop in U for cycle lt 40 U gt 60 drop in U for 5 cycles lt 70 U gt 30 drop in U for 25 cycles lt 5 U gt 95 drop in U for 5s 0 3 A m HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 21 Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered withs ynthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of this product requires continued function even in the event of interruptions in the energy supply this product should be powered from an un interruptible power supply or a battery Power frequency magnetic fields should be at levels char acteristic of a typical location in a typical commercial or hos pital environment 21 09 04 2014 09 47 44 F 4 Immunity on non life support devices standard table 4 Guidance and manufacturer s declaration electromagnetic immunity This product is intended for use in the electromagnetic environment specified below The customer or the user of this product should assure that it is used in such an
22. f conformity m Year of production 09 04 2014 09 47 33 Alternating current HS reference number T Cone option CSN Serial number IP20 Housing protection 14 Dust cover for storage packaging f 15 T Cone topography add on 16 Trademark of the manufacturer 16 Top shows which side of the T Cone is up 17 HS HAAG STREIT AG 17 Locking release clip 18 18 Type plate 19 2 Introduction 19 Base plate for storage packaging 20 20 Short forehead band with four Phillips screws 2 1 Basic construction p pee 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 using the EyeSuite Device state f PEN software installed on the PC Integral automatic error recognition for measurements The device state indicator allows device monitoring without PC software guarantees reliable examination results 21 State indicator Dark Off haere Orange Standb 2 2 Examination components LS 900 aan On i Overview Blue Light source on 1 Front ring 8 i RED ERROR 2 Housing 9 3 Service cover 4 Cable cover 10 ue 5 Control lever Control le vet iis nai 6 Type plate 1 The joystick is used to position the device in 7 Side identification sticker relation to thie patients eye 12 22 Trigger Head rest option 8 Head rest 9 Headband l Connections 10 Mark for o
23. ing the CE mark we confirm that our device complies with the applicable stan dards and directives e You can request a copy of the declaration of conformity for the device from HAAG ST REIT at any time HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 09 04 2014 09 47 43 C Classification C 1 LENSTAR LS 900 biometer EN 60601 1 Continuous operation EN 60825 1 Laser class EN 60529 Enclosure protection IP20 EN 62471 Risk group 1 EN ISO 15004 2 Group 2 93 42 EEC medical devices Class lla FDA Class II cC 2 T Cone option ISO 19980 2005 Corneal topograph type B ANSI Z80 23 2008 Corneal topograph type B 93 42EEC medical devices Class FDA Class D Disposal Electrical and electronic devices must be disposed of separately from household waste This appliance was made available for sale after the 13th August 2005 For correct disposal please contact your HAAG STREIT representative This will guarantee that no hazardous substances enter the environment and that valuable raw materials are recycled aay E Standards EN 60601 1 EN ISO 15004 1 EN 60601 1 2 EN ISO 15004 2 EN 62471 EN ISO 10343 EN 60825 1 EN ISO 22665 EN 60529 ISO 19980 ANSI Z80 23 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 19 19 09 04 2014 09 47 44 e Electrical medical devices and systems are
24. invisibly wired by passing cables through the cross slide and us ing the cable channel underneath To do this you need either the HAAG STREIT instrument table HSM 901 option or an aperture in the table top used Remove cable cover 50 Expose USB and supply cables table aperture 51 Insert the supply cable through the opening beneath the cross slide until the cable emerges from the opening at the top at the front 52 Insert the USB cable through the same opening 52 on the cross slide e Insert both cables in the appropriate box and fix with the tension compensator 53 Replace the cable cover 54 Replace the rail cover 11 09 04 2014 09 47 40 12 3 3 2 Device connection cables at side option e Remove cable cover 55 Expose USB and supply cables left or right aperture on rail cover e With a knife cut carefully into the snap off point provided on the left or right of the ca ble cover 56 e Carefully use fingers to snap off the cut part 57 Insert both cables in the appropriate box and fix with the tension compensator e Join both cables together with a spiral wrap and fix in place using the cable channel on the rail cover 58 e Replace cable cover e Replace the rail cover 3 4 Computer connection WARNING For connection to PC only use the supplied USB cable 2 m 01 IFU_LS900 7220055 04070_eng indd 12 Connect the electric power supply cable Integral mai
25. ith the Lenstar The User Group for Laser Interference Biometry ULIB at the University of Wurzburg Germany has published on its website a manual explaining how to correct the effect of ultrasound biometry and keratometry on the IOL constants Constants acquired in such a way should only be used as a starting point for further optimisation per sonalisation 1 7 Optical radiation WARNING A The light from this device may be dangerous The risk of eye damage increases with the irradiation period An exposure time with this device at maximum intensity of over 100 individual measurements per patient eye with dilated pupil per day exceeds the risk guideline value NOTE In accordance with EN 60825 1 the limiting values for class 1 lasers are respected when the device is used in the defined manner NOTE The device complies with the limit values for risk group 1 in accordance with EN 62471 insofar as no more than 100 individual measurements are performed per day and per patient s eye with dilated pupil If this lim it value of 100 individual measurements is exceeded the patient s eye may be damaged by the white illumination Radiance 1800 Wm sr 3 i HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 7 1 8 Disinfection NOTE The device does not need to be disinfected e If the optional T Cone is used its tip must be cleaned wi
26. ivo repeatability 1 SD 0 08 mm 6 3 4 Axial length AL leasurement range 14 32 mm Display resolution 0 01 mm In vivo repeatability 1 SD 0 035 mm 15 09 04 2014 09 47 43 6 3 5 Keratometry R Measurement range radius 5 10 5 mm Display resolution 0 01 mm In vivo repeatability 1 SD 0 03 mm Measuring area of axial angle 0 180 Display resolution 1 In vivo repeatability 1 SD 11 6 3 6 White to white distance WTW Measurement range 7 16mm Display resolution 0 01 mm In vivo repeatability 1 SD 0 04 mm 6 3 7 Pupillometry Measurement range 2 13mm Display resolution 0 01 mm Tab 1 All Eyes 16 The above mentioned measurement ranges correspond to the default setting for the automatic analysis The in vivo reproducibility was evaluated in a clinical study of cataract patients see Tables 1 All eyes and 2 Special eyes 6 3 8 Study design e The clinical trial for deriving in vivo reproducibility was approved by the local ethics committee The study was planned and conducted as a prospective non randomised comparative study Two phases were scheduled in the approved study protocol In the first phase mea surements of axial length AL central corneal thickness CCT anterior chamber depth ACD central lens thickness LT median corneal radius R and the axis posi tion of the flat meridian axis were taken The white to white distance WTW was measured in the second phase
27. lmology 2009 116 2087 2092 1 6 4 IOL constants HAAG STREIT recommends using personalised IOL constants to achieve maximum prediction accuracy of the IOL calculation Using personalised IOL constants minimis es the effects of individual surgical techniques individual measurement and surgical equipment and individual physiological differences in the patient cohort under treat ment on the IOL calculation HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 09 04 2014 09 47 32 1 6 5 IOL constants derived using data from an immersion ultrasound biometer If there are optimised IOL constants available from an immersion ultrasound biome ter they may be used as a starting point for further optimisation of IOL calculation with the Lenstar Differences in IOL calculation may still occur as the keratometry data are collected in different ways The User Group for Laser Interference Biometry ULIB at the University of Wurzburg Germany has published on its website a manual explain ing how to correct the effect of keratometry on the IOL constants Still the IOL con stants acquired in this way should only be used as a starting point for further optimisa tion personalisation 1 6 6 IOL constants derived from data from a contact ultrasound biometer If there are optimised IOL constants available based on data from a contact ultra sound biometer they must be stringently recalculated for use w
28. nation LS 900 Dimensions W x D x H 310 x 260 x 420 mm Weight 6 2 kg 6 1 Power supply FRIWO 3288 DT12 12 HED HS No 1020392 6 1 1 Primary side Voltage 100 240 V 50 60 Hz Current 280 140 mA 6 1 2 Secondary side Voltage 12 V Current 1A 6 2 Illumination modalities 6 2 1 Eye length measurement A Scan and central fixation 6 2 2 Keratometry Light source Wavelength 6 2 3 Illumination Light source Light colour LED 950 nm Serial number of the system Up to 1999 From 2000 LED LED Green White Devices with a serial number lt 1999 can be subsequently converted to white light illumination 6 2 4 Positioning aid from serial number 2000 Light source Wavelength LED 940 nm 6 3 Measured variables Lenstar LS 900 leasurement range isplay resolution n vivo repeatability 1 SD 50 leasurement ranges are based on the Phakic measurement mode 6 3 1 Central corneal thickness CCT 300 800 um 1 um 2 3 um 6 3 2 Anterior chamber depth ACD Light source Superluminescent diode Wavelength 820 nm Power on patient s eye lt 0 6 mW HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 15 leasurement range 1 5 6 5 mm Display resolution 0 01 mm In vivo repeatability 1 SD 0 04 mm 6 3 3 Lens thickness LT leasurement range 0 5 6 5 mm Display resolution 0 01 mm In v
29. ns components work with the voltages specified under section A 1 1 Electrical data It is not necessary to select the voltage on the device e If an instrument table HSM 901 option has been supplied the power supply of the LS 900 can be connected to the Switchbox SB01 left drawer Use the instructions for use enclosed with the switchbox and the instrument table 3 5 Installing a short forehead band when using the optional T Cone NOTE If the Lenstar LS 900 biometer with the optional T Cone topography add on is used on an instrument table with a HAAG STREIT head rest HS art no 7200123 the short forehead band delivered with the op tional T Cone must be used on the head rest for better measurability If the Lenstar is operated without the optional T Cone the short forehead band does not need to be replaced with the long one Detach the forehead band by removing the four Phil lips screws 60 using a size 1 Phillips screwdriver e Remove the forehead band 59 Insert the short forehead band HS art no 1021653 into the head rest and align the holes with 60 the holes in the head rest Attach the short forehead band using the four Phil lips screws supplied 4 Operation 4 1 Position of patient during measurement Positioning of the device is done manually by the user The patient must be posi tioned in such a way that the distance from the measuring head to the eye is ap prox 68 mm A steady head position is
30. o take into account the type e g posterior subcapsular cataract and density of the cataract when evaluating plausibility e Prior to the measurement the user must verify that the patient is not wearing contact lenses Wearing contact lenses will result in erroneous measuring results It may not be possible under certain circumstances to carry out mea surements on persons with fixation problems In cases of thick cataracts and uncertain measurement of the axial length ultrasound biometry should be performed as a control examina tion 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 impossi ble 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 have undergone keratore fractive surgery because such eyes may significantly deviate from spher ical surfaces e The user should make a visual check when carrying out the measure ment procedure to ensure that all light spots are present e If the device repeatedly generates error messages stop using it and con tact the customer service You are recommended always to examine both of the patient s eyes five times The user should subject the measurement readings to extra scru tiny if there is a notabl
31. otton bud must not be so wet that it drips Ensure that the T Cone is dry after the cleaning Information on cleaning the T Cone can be found un der Cleaning Retract the Lenstar T Cone completely before positioning the patient in the head rest Always start the measuring procedure with the Lenstar T Cone in the position furthest away from the patient Explain to the patient that he should focus on the red flashing light measuring beam in the centre of the T Cone The second eye the one not being measured can be cov ered with the eye patch on the optional head rest Start the measuring procedure by pressing the button on the joystick and following the instructions on your PC screen Detailed information on the measuring procedure can be found in the operating instructions for the software F1 key 13 09 04 2014 09 47 42 14 NOTE Ensure that the Lenstar T Cone is in the position furthest away from the patient before switching from the first eye to the second eye This ensures that the T Cone will not touch with the bridge of the patient s nose 4 2 3 Removing the optional T Cone e Hold the T Cone by the metal ring and press the locking N clip Now remove the T Cone by tilting it off the front ring of the Lenstar as shown in the image Place the T Cone on the base plate of the storage pack aging 19 e Place the dust cover 14 on the base plate of the storage packaging 19 to protect the T Cone from du
32. promoted by resting the patient s head in good contact with 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 The patient should sit up as straight as possible HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 09 04 2014 09 47 41 a D NOTE In order to get the best possible results the patient should be request ed to keep the eye as wide open as possible during the measurement and to focus on the measuring beam Blinking is permitted but should be kept to a minimum 4 2 Measuring with the optional T Cone 4 2 1 Fitting the optional T Cone e Remove the dust cover from the storage packaging e Hold the T Cone with the locking clip 17 pressed down next to the metal ring and fit it on the front ring of the Len star as shown on the illustration Keep the locking clip depressed so that the T Cone lies flush with the front ring Make sure that TOP on the metal ring of the T Cone is at the top The T Cone is held in place on the front ring of the Lenstar LS 900 biometer by strong magnets Ensure that the red safety mark is no longer visible on the locking clip If the red safety mark is still visible remove the T Cone and fit it again L The T Cone is fitted correctly The red safety mark is not visible The T Cone is not fitted corre
33. ptimum eye 13 23 USB device connection height 24 DC device connection 11 Chin rest 25 USB 2 0 cable 12 Chin rest height adjust 26 DC cable ment i 27 Cable tension compensator 13 Hand grips for patient 8 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 8 09 04 2014 09 47 37 2 3 Control component PC Acommercial PC is used as the control component for the biometer WARNING The software must be installed by trained personnel in accordance with the separate installation instructions For further information please contact your HAAG STREIT representative 2 4 Instrument table option An adjustable instrument table option allows the height of the device to be set at a comfortable height for the individual patient 28 Table top 29 Left hand drawer for external medical power supply Switch box SB01 30 Right hand drawer empty 31 Elevator column mechanical with spring 32 Stand base with castors e eal 28 a 7 29 30 31 32 a 0 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 01 IFU_LS900 7220055 04070_eng indd 9 3 Appliance assembly installation 3 1 Safe system configuration according to EN 60601 1 i D DANGER e It is not permitted to make modifications to the meas
34. s re move the dust cover before switching on the power WARNING The device must not be switched on when covered Heat build up fire hazard 8 3 Maintenance of T Cone option The optional T Cone requires practically no maintenance apart from the cleaning of the tip between patients see Measuring with the T Cone 01 IFU_LS900 7220055 04070_eng indd 18 A Appendix A 14 Accessories spare parts A1 1__LENSTAR LS 900 Component HS art no T Cone Toric Platform 7220397 EyeSuite IOL Toric Planner 7220396 Electric power supply lead CH 1001319 USA power supply lead 1001316 Dust cover small 1001395 Checking gauge replacement 1021124 Head rest LS 900 7200123 Eye patch 1400113 Instrument table HSM 901 Workstation manual 7220085 Instrument table HSM 901 Workstation electric lifting column 230 V 7220149 A14 2 T Cone option Component HS art no T Cone without Toric Planner only for use with the Eyesuite IOL Toric Plan 7220384 ner installed Dust cover for storage packaging 1021665 Base plate for storage packaging 1021666 Short forehead band with 1021653 Phillips screws for forehead band 4 pcs 1005072 B Legal regulations e HAAG STREIT maintains a quality management system in accordance with EN ISO 13485 The device has been developed and designed taking into consideration all the standards listed in section E Standards e This is a Class Ila device in accordance with Appendix IX of Directive 93 42 EEC By affix
35. seesseesueeeseesnseeenseess Appendix Accessories spare parts LENSTAR LS 900 A Esin ie r h DEENA PNE EAA AEE APE AES ENE T Pegall regulations icsasccsctesectedendccsctace tassctecsetactatcstetadateadeatonses 18 Classification LENSTAR LS 900 biometer T Cone option DISPOSal A EE AE E E 19 Standards wissiscsscicssiscsccttsionsscaicsincaraitsiansaatiaatiacaatin 19 EMC supplement GONG alll cd scenes EE Emitted interference standard table 1 Immunity standard table 2 Immunity on non life support devices standard table 4 Safe distances on non life support devices standard table 6 09 04 2014 09 47 31 Safety DANGER Failure to comply with these instructions may result in material damage or pose a danger to patients or users WARNING These warnings must absolutely be complied with to guarantee safe operation of the device and to avoid any danger to users and to patients NOTE Important information please read carefully eo 1 14 Areas of application of the device The device is intended for use in doctor s practices hospitals optometrists and op ticians premises 1 2 Patient population The patient must be capable of sitting up straight and keeping his head still He must be physically and mentally able to cooperate well and mentally capable of fol lowing the examination Patients must be at least 6 years old 1 3 Ambient conditions Transport
36. st and dirt 4 3 Fixation To obtain usable results the patient must stare at the red fixation light in the mea suring lens during measurement If the patient has difficulty seeing the fixation light with the eye being measured this can be remedied by fixating a remote object with the other eye 4 4 Measured variables 4 4 1 A Scan Depending on the patient s gaze at the fixation light the optical path length of the visual axis is measured 61 CCT Central corneal thickness AD Aqueous depth back of cornea to front of lens LT Lens thickness AL Eye length front of cornea to the inner limiting membrane 01 IFU_LS900 7220055 04070_eng indd 14 NOTE Since the device measures up to the retinal pigmented epithelium the reading displayed is adjusted to the internal limiting membrane either automatically as a function of axial length or manually according to the mode selected Manual correction is not available in the USA 4 4 2 Keratometry Keratometry is calculated through the position of 32 projected light reflections Two tings with sixteen measuring points on each eye are arranged in two rings with the following diameters standard eye R 7 8 mm 2 3 mm 1 65 mm Outer measuring points Inner measuring points For each measuring point the equivalent of an ideal sphere is calculated The values displayed flat radius steep radius corre spond to the radii of an ellipsoid that fits into the arr
37. subject to special EMC mea F 1 General i k r sures and must be installed in accordance with the EMC instructions con The Lenstar LS 900 complies with the standard EN 60601 1 2 The instrument is tained in this accompanying document constructed such that the generation and emission of electromagnetic interference Portable and mobile HF communication systems may interfere with elec is limited so as not to disrupt the intended use of other devices while the instrument trical medical devices itself possesses an appropriate immunity to electromagnetic interference The use of cables or equipment other than those listed may lead to a higher emission or to reduced interference immunity of the Lenstar LS 900 biometer system F EMC supplement A WARNING F 2 Emitted interference standard table 1 Guidance and manufacturer s declaration electromagnetic emissions This product is intended for use in the electromagnetic environment specified below The customer or the user of this product should assure that it is used in such an envi ronment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B This product is suitable for use in all establishments including domestic establishments and those
38. th max 70 al cohol after each patient For more information on cleaning please refer to the Maintenance section 1 9 Warranty and product liability e Haag Streit products must be used only for the purposes and in the manner described in the documents distributed with the product e The product must be treated as described in the Safety chapter Improper handling can damage the product This would void all guarantee claims e Continued use of a product damaged by incorrect handling may lead to personal inju ry In such a case the manufacturer will not accept any liability e Haag Streit does not grant any warranties either expressed or implied including im plied warranties of merchantability or fitness for a particular use Haag Streit expressly disclaims liability for incidental or consequential damage result ing from the use of the product e This product is covered by a limited warranty granted by your seller e The optional T Cone must be stored in its original dust cover and protected from direct sunlight For USA only e This product is covered by a limited warranty which may be reviewed at www haag streit usa com 1 10 Symbols Ci Read the instructions for use attentively GR Test symbol of CSA with ap c proval for USA US General warning Read the ac companying documentation X Notes on disposal see the Disposal chapter a Manufacturer Direct current European certificate o
39. tion 17 09 04 2014 09 47 43 18 8 14 Function check zero adjustment The inspection gauge 65 supplied with the device N will assist the user in checking the proper function ing of the unit The type plate with the serial num fi ber can be found on the rear of the gauge This es ee check takes place for the first time when the de a aa vice is commissioned Subsequent test intervals H f 1 week will be specified by the software mes sage displayed For exact procedure see software instructions for use Should the test be outside the tolerance limits a software message appears and the unit must be taken out of use Notify your HAAG STREIT customer support center 8 2 Cleaning Regular dusting of the device with a soft cloth is sufficient More stubborn dirt can be removed using a soft lint free cloth dampened with water or alcohol at maxi mum 70 WARNING Avoid making the device wet and use only the means listed above Under no circumstances use solvent or any abrasives The T Cone must never be immersed in cleaning fluid or disinfectant No abrasive or otherwise aggressive agents must be used for cleaning disin fection Suitable media include water and up to 70 alcohol Ensure that the T Cone is dry after every cleaning disinfection A dust cover is included in the accessories of the LS 900 Cover the device when the room is being cleaned or if it is not used for longer periods of time Alway
40. uring device WARNING The device must only be installed on a stable horizontal surface All externally connected devices must comply with the standards rele vant to safety NOTE After installation a zero adjustment and function check must be per formed in accordance with the section Function check e The device should be set up in such a way that the plug is always eas ily accessible and the device can easily be disconnected from the pow er supply 09 04 2014 09 47 37 3 2 Instrument table option assembly The instrument table is delivered in a separate package 33 Power supply LS 900 To assemble the table please consult the instructions for use enclosed with it 34 Instrument table 35 Isolation Transformer l 3 2 1 Mounting the roller rails slide plate 36 Laptop PC The roller rails slide plate must be positioned in such a way that when the device is 37 Power supply PC centered the patient s eye will be at a distance of 78 mm from the front of the de 38 Printer Galvanic vice isolation 4 kV 39 Rail 12DC 1A USB 2 0 LAN 40 Side identification sticker 33 41 Slide plate 42 Headrest columns 43 Aperture for cables 300 292 200 2 a 15022 27 42 lt e Ong JO a OA 8 g N gt g i gt 3 f ce Sa 30 g 39 i 43 40 o mM 41 70 l oO he g
41. xis Axis of flat meridian ACD Anterior chamber depth WTW White to white distance HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04070 7 Edition 2014 01 09 04 2014 09 47 43 6 4 Technical data of T Cone option Type designation T Cone Diameter 84 mm Length 63 5 mm Weight 0 2 kg Placido rings 11 Covered optical zone lt 6mm 6 4 1 Normative considerations The T Cone complies with the requirements of the ISO 19980 2012 standard for the central and medial measuring zones the T Cone does not cover the peripheral mea suring zone e International standard for ophthalmological instruments e Corneal topographer type B The T Cone complies with the requirements of the ANSI Z80 23 2012 standard for the central and medial measuring zones the T Cone does not cover the peripheral mea suring zone e US national standard for ophthalmological instruments Corneal topography system type B 6 4 2 Measuring accuracy Test surface axial curvature difference in mm elevation difference in um Central zone Diameter lt 3 mm Middle zone 3 lt Diameter lt 6 mm Mean value 2st dev 2st dev Meanvalue 2st dev 2 st dev Curvature Curvature Elevation Curvature Curvature Elevation diff diff diff diff diff diff Toric mm Ri 7 987 0 006 0 065 0 66 0 004 0 044 0 33 Ro 7 584 Ellipsoid mm R 7 79 0 001 0 083 0 78 0 020 0 038 1 51 k 0 255 Sphere 1 mm REG 448 0 013 0 037 0 61 0 012 0
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