Lenstar-User
Contents
1. 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 04080_eng indd 4 Check the device for damage after it is unpacked Return defective devices in the appropriate packaging Store packaging material carefully so that it can be used for possible returns or when moving Only use the original packaging material for moving the device Check that the contents of the packaging correspond to the contents specified on the leaflet included in the packaging 1 5 Installation warnings WARNING 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 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 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 The device should be set2. 1 6 4 1 6 5 1 6 6 1 7 1 8 1 9 1 10 2 1 22 23 24 3 1 3 2 4 1 4 2 43 4 3 1 4 3 2 4 3 3 4 4 45 4 5 1 4 5 2 4 5 3 4 5 4 Safety Areas of application of the device Patient population Ambient conditions Shipment and unpacking installation warnings Operation environment Plausibility of the measurements OL calculation References OL constants OL constants derived using data from an immersion ultrasound biometer OL constants derived from data from a contact ultrasound biometer Optical radiation Disinfection Warranty and product liability SV MOMS ss Ean o Introduction Basic construction Examination components LS 900 Control component PC nstrumonit table OPO accionistas 9 Appliance assembly installation Computer connection AA installing a short forehead band when using the OpUONAl T CONG si aria artagarau 9 Operation Position of patient during measurement Measuring with LENSTAR APS optional Optional T Cone Fitting the optional T Cone Measuring with the optional T Con Removing the optional T Cone Fixation Measured variables White to white distance IURIS EEEa HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 04 11 2014 09 43 43 5 1 5 2 6 1 6 2 6 2 1 6 2 2 6 3 6 3 1 6 3 2 6 3 3 6 3 4 6 4 6 4 1 6 4 2
3. 6 4 3 6 4 4 6 4 5 6 4 6 6 4 7 6 4 8 6 5 6 5 1 6 5 2 6 5 3 8 1 8 2 8 3 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 Commissioning Switching on the device Switching off the device Power supply Primary side Secondary side Illumination 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 Anterior chamber depth ACD Lens thickness LT Axial length AL Keratometry R White to white distance WTW Pupillometry a Study design Technical data of T Cone option Normative considerations Measuring accuracy Reproducibility 3 Software Help menu Error messages ccccacnonanmoss 15 Maintenance Function check zero adjustment ClO ANN O irene Maintenance of T Cone option 01 IFU_LS900 7220055 04080_eng indd 3 AA A1 1 A 1 2 C 1 C 2 Ed F2 ES EA EA Appendix Accessories spare parts LENSTAR LS 900 E UEa i EEE Legal regulations Classification LENSTAR LS 900 biometer 16 T Cone option 11111 e AEE 16 Standar dianas di dada 16 EMC supplement General Emitted interference standard table 1 Immunity standard table 2 Immunity on non life su
4. Notebook PC The examination part communicates via a USB connection with the external PC The LS 900 is operated using the EyeSuite software installed on the PC Integral automatic error recognition for measurements guarantees reliable examination results 2 2 Examination components LS 900 Overview 1 Front ring 8 1 Housing 9 Service cover Cable cover 10 Control lever Type plate 11 Side identification sticker YN GO GO d GO PA 12 Head rest option 8 Head rest 9 Headband 10 Mark for optimum eye 13 height 11 Chin rest 12 Chin rest height adjust ment 13 Hand grips for patient 01 IFU_LS900 7220055 04080_eng indd 8 T Cone option 14 Dust cover for storage packaging He 15 T Cone topography add on 16 16 Top shows which side of the T Cone is up 17 17 Locking release clip 18 18 Type plate 19 19 Base plate for storage packaging 20 20 Short forehead band with four Phillips screws Device state The device state indicator allows device monitoring without PC software 21 State indicator Dark Off Orange Standby Green On Blue Light source on RED ERROR 22 Control lever The joystick is used to position the device in relation to the patient s eye 22 Trigger Connections 23 USB device connection 24 DC device connection 25 USB 2 0 cable 26 DC cable 27 Cable tension compensator HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 15
5. 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 8 kV 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 3 A m NOTE U the AC mains voltage prior to application of the test level 01 IFU_LS900 7220055 04080_eng indd 18 Compliance level 6 kV contact 8 kV 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 Y 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 5 s 0 3 A m 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
6. 60601 1 Continuous operation Component HS art no EN 60825 1 Laser class T Cone Toric Platform 7220397 EN 60529 Enclosure protection IP20 EyeSuite IOL Toric Planner 7220396 EN 62471 Risk group 1 Electric power supply lead CH 1001319 EN ISO 15004 2 Group 2 E leat EEE 93 42 EEC medical devices Class lla Dust cover smal 1001395 FDA Class II Checking gauge replacement 1021124 Head rest LS 900 7200123 Eye patch 1400113 C 2 T Cone option Instrument table HSM 901 Workstation manual 7220085 ISO 19980 2005 Corneal topograph type B Instrument table HSM 901 Workstation electric lifting column 230 V 7220149 ANSI Z80 23 2008 Corneal topograph type B 93 42 EEC medical devices Class A 1 2 T Cone option FDA Class Component HS art no T Cone without Toric Planner only for use with the Eyesuite IOL Toric Plan 7220384 ner installed D Disposal Dust cover for storage packaging 1021665 Electrical and electronic devices must be disposed of separately from Base plate for storage packaging 1021666 household waste This appliance was made available for sale after the Short forehead band with 1021653 13th August 2005 For correct disposal please contact your Phillips screws for forehead band 4 pcs 1005072 HAAG STREIT representative This will guarantee that no hazardous 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 cons
7. 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 20 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 20 04 11 2014 09 43 53 SVENSKA IT NEDERLANDS PORTUGUES ESPANOL ITALIANO FRANCAIS DEUTSCH E HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 21 04 11 2014 09 43 53 m DEUTSCH FRAN AIS ITALIANO ESPANOL PORTUGUES NEDERLANDS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 22 04 11 2014 09 43 53 SVENSKA IT NEDERLANDS PORTUGUES ESPANOL ITALIANO FRANCAIS DEUTSCH E HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 23 04 11 2014 09 43 53 Should you have any further questions please contact your HAAG STREIT dealer at http www haag streit com contact contact your distributor html En 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 Managem
8. manually according to the mode selected Manual correction is not available in the USA 11 04 11 2014 09 43 50 4 5 2 Keratometry Keratometry is calculated through the position of 32 projected light reflections Two rings 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 array of points The axis of its rotation is measured count er clockwise from the horizontal to the flat radius 35 e Flat radius f Steep radius g Axis of rotation 4 5 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 36 36 37 4 5 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 37 0
9. not touch with the bridge of the patient s nose HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 11 4 3 3 Removing the optional T Cone Hold the T Cone by the metal ring and press the locking clip 17 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 Place the dust cover 14 on the base plate of the storage packaging 19 to protect the T Cone from dust and dirt 4 4 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 5 Measured variables 4 5 1 A Scan Depending on the patient s gaze at the fixation light the optical path length of the visual axis is measured 34 ee A EGO de ZEZ lens LT Lens thickness AL Axial eye length front of cornea to the inner limiting membrane CCT Central corneal thickness AD Aqueous depth back of cornea to front of A CCT LT NOTE gt 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
10. 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 1 6 Operation environment DANGER e Itis not permitted to make modifications to the measuring device 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 04 11 2014 09 43 44 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 e We recommend checking the calibration of the optional T Cone when fit ting it and repeating this if necessary see section Function check NOTE e 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 sof
11. 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 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 Th
12. 00 7220055 04080 8 Edition 2014 11 04 11 2014 09 43 49 2 3 Control component PC Acommercial PC is used as the control component for the biometer WARNING NM 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 A En E edi D o 0 IR 28 eet Sel 29 30 31 32 3 Appliance assembly installation WARNING The device must be installed by trained personnel in accordance with the installation instructions provided in the separate service manual HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 9 3 1 Computer connection WARNING For connection to PC only use the supplied USB cable 2 m Connect the electric power supply cable Integral mains components work with the voltages specified under section A 1 1 Electrical data It is not necessary to select the voltage on the device
13. 01 IFU_LS900 7220055 04080_eng indd 1 LENSTAR 2 gt INSTRUCTIONS FOR USE Biometer Lenstar LS 900 8 Edition 2014 11 ME HAAG STREIT DIAGNOSTICS 04 11 2014 09 43 43 INSTRUCTIONS FOR USE Biometer Lenstar LS 900 8 Edition 2014 11 Introduction Thank you for choosing a HAAG STREIT device Provided you comply careful ly with the regulations in these instructions for use we can guarantee reliable and trouble free use of our product WARNING Read the instruction manual carefully before commissioning this pro duct It contains important information regarding the safety of the user Cli and patient NOTE Federal law restricts this device to sale by or on the order of a physician or licensed practitioner Intended use The LS 900 is a non invasive non contact OLCR optical low coherence reflectom etry 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 mea sures Axial eye length Corneal thickness Anterior chamber depth Aqueous depth Lens thickness Corneal curvature Radii for flat and steep meridian Axis of the flat meridian White to white distance Pupil diameter 01 IFU_LS900 7220055 04080_eng indd 2 Contents 1 1 1 1 2 1 3 14 1 5 1 6 1 6 1 1 6 2 1 6 3
14. 1 IFU_LS900 7220055 04080_eng indd 12 5 Commissioning Power for the LENSTAR LS 900 is supplied by a medical grade power supply which is provided with the device Only use the power supply provided with the device 5 1 Switching on the device Connect the power supply plug to the mains Switch on the PC Start the software on the PC 5 2 Switching off the device Exit the software on the PC Switch off the PC Disconnect the power supply plug from the mains if you do not intend to use the de vice for an extended period of time 6 Technical data Type designation LS 900 Dimensions W x D x H 310 x 260 x 420 mm 6 1 Weight LENSTAR 6 2 kg LENSTAR APS 6 6 kg 6 2 Power supply LENSTAR FRIWO 3288 DT12 12 HED HS No 1020392 LENSTAR APS ICCN EXERGY ELPAC POWER SYSTEMS Model MWA030018B HS No 1022106 6 2 1 Primary side Voltage 100 240 V 50 60 Hz Current LENSTAR 280 140 mA Current LENSTAR APS 800 mA 6 2 2 Secondary side LENSTAR Voltage 12 V 5 Current 1A LENSTAR APS Voltage 18 V 5 Current 1 7A HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 04 11 2014 09 43 50 6 3 Illumination modalities 6 3 1 Eye length measurement A Scan and central fixation Light source Wavelength Power on patient s eye 6 3 2 Keratometry Light source Wavelength 6 3 3 Illumination Light source Light colour
15. 19 01 IFU_LS900 7220055 04080_eng indd 19 04 11 2014 09 43 52 F 4 Gaie 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 5 GHz Nominal output of the transmitter W D 1 2 P D 1 2 P D 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 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
16. EN ei on the front ring of the Lenstar LS 900 biometer by strong L O A magnets b 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 The T Cone is not fitted correctly The red safety mark is visible Please remove the T Cone and fit it again 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 e 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 The T Cone is fitted correctly The red safety mark is not visible HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 04 11 2014 09 43 50 NOTE gt 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 a
17. 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 2 Installing a short forehead band when using the optional T Cone NOTE gt 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 33 Phillips screws E 34 Forehead band 3 A Detach the forehead band by removing the four Phil lips screws 34 using a size 1 Phillips screwdriver 34 Remove the forehead band 33 Insert the short forehead band HS art no 1021653 into the head rest and align the holes with d the holes in the head rest Attach the short forehead band using the four Phil lips screws supplied 5 2 04 11 2014 09 43 49 4 Operation 4 14 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 promoted by resting the patient s head in good contact w
18. Superluminescent diode 820 nm lt 0 6 mW 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 3 4 Positioning aid from serial number 2000 Light source Wavelength LED 940 nm 6 4 Measured variables Lenstar LS 900 Measurement ranges are based on the Phakic measurement mode 6 4 1 Central corneal thickness CCT Measurement range Display resolution In vivo repeatability 1 SD 300 800 ym 1 um 2 3 um 6 4 2 Anterior chamber depth ACD Measurement range Display resolution In vivo repeatability 1 SD 1 5 6 5 mm 0 01 mm 0 04 mm HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 13 6 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 6 4 4 Axial length AL Measurement range 14 32 mm Display resolution 0 01 mm In vivo repeatability 1 SD 0 035 mm 6 4 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 4 6 White to white distance WTW Measurement range 7 16 mm Display resolution 0 01 mm In vivo rep
19. Test surface axial curvature difference in mm elevation difference in um Axis 3 6 80 13 0 16092 Central zone Diameter lt 3 mm Middle zone 3 lt Diameter lt 6 mm Eg Mean value 2st dev 2st dev Meanvalue 2st dev 2st dev Abbreviations Curvature Curvature Elevation Curvature Curvature Elevation n Number of subjects number of eyes ait diff ehig E ait diff Toric mm Meangrand Overall mean of results on all eyes R 7 987 0 006 0 065 0 66 0 004 0 044 0 33 SDrepeat Repeatability standard deviation R2 7 584 cv Coefficient of variation Ellipsoid mm R 7 79 0 001 0 083 0 78 0 020 0 038 1 51 SD Standard deviation LT Lens thickness k 0 255 AL Axial length R Corneal radius of curvature dd mm 0 013 0 037 0 61 0 012 0 025 1 12 14 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 14 04 11 2014 09 43 50 Sphere 2 mm g 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 _ J R 10 501 0 040 0 082 0 48 0 069 0 044 0 58 Sphere 1 11 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 5 3 Reproducibility Human cornea axial curvature difference D elevation difference um Central Zone Middle zone Diameter
20. al data of T Cone option all eyes see Tab 1 and for a subgroup of eyes with special health conditions see Type designation T Cone Tab 2 with a complete set of 5 repeat measurements on both eyes of each subject Diameter 84 mm The special eyes group included eyes with one or more of the following conditions Length 63 5 mm pseudophakia aphakia and silicone oil fill Weight 0 2 kg Tab 1 All Eyes Placido rings 11 Covered optical zone lt 6 mm unit n Meangrand SDrepeat cv Eze AL immi ee aS EE GEI 6 5 1 Normative considerations CCT um 53 106 557 1 2 3 0 00407 The T Cone complies with the requirements of the ISO 19980 2012 standard for the ACD mm 34 68 3 19 0 04 0 01220 central and medial measuring zones the T Cone does not cover the peripheral mea LT mm 27 54 4 56 0 08 0 01784 suring zone Ha R mm 34168 767 0 03 0 00396 International standard for ophthalmological instruments re e Corneal topographer type B Axis 27 54 72 11 0 14191 The T Cone complies with the requirements of the ANSI Z80 23 2012 standard for the WTW mm 9 18 12 27 0 04 0 00337 central and medial measuring zones the T Cone does not cover the peripheral mea Tab 2 Special Eyes Suring zone o z US national standard for ophthalmological instruments unit n Meangrand SDrepeat cv Corneal topography system type B AL mm 10 20 24 087 0 056 0 00234 CCT um 11 22 564 4 2 8 0 00496 6 5 2 Measuring accuracy ACD mm 5 10 7 75 0 03 0 00333
21. e 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 04080_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 User 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 Co
22. eatability 1 SD 0 04 mm 6 4 7 Pupillometry Measurement range 2 13 mm Display resolution 0 01 mm 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 4 8 Study design 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 13 04 11 2014 09 43 50 A total of 144 eyes in 80 subjects were included in study phase 1 and a total of 40 CCT Central corneal thickness Axis Axis of flat meridian eyes in 20 subjects in study phase 2 a A ee Subjects with different conditions of the anterior and posterior segment of the eye cat ACD Antenor chamber depth WTW ivhite lo whie distance 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 6 5 Technic
23. ent System HAAG STREIT AG c ual Gartenstadtstrasse 10 n 1250 3098 Koeniz Switzerland Phone 41 31 978 01 11 pce trang Fax 41 31 978 02 82 eMail info haag streit com Internet www haag streit com 01 IFU_LS900 7220055 04080_eng indd 24 04 11 2014 09 43 53
24. evice is switched off before attaching the dust cover 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 01 IFU_LS900 7220055 04080_eng indd 5 E 1 6 1 A Only original spare parts and original accessories may be used for repairs The software must be installed by trained personnel 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 gt 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 also 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 unde
25. 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 ZI I HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_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 with 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 des cribed in the documents distributed with the product e The product must be treated as de
26. ideration all the standards listed in section E Standards This is a Class lla device in accordance with Appendix IX of Directive 93 42 EEC By affixing the CE mark we confirm that our device complies with the applicable stan dards and directives You can request a copy of the declaration of conformity for the device from HAAG STREIT at any time 01 IFU_LS900 7220055 04080_eng indd 16 substances enter the environment and that valuable raw materials are 22 recycled E Standards EN 60601 1 EN 60601 1 2 EN 62471 EN 60825 1 EN 60529 ANSI Z80 23 EN ISO 15004 1 EN ISO 15004 2 EN ISO 10343 EN ISO 22665 ISO 19980 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 04 11 2014 09 43 51 F EMC supplement F1 General The Lenstar LS 900 complies with the standard EN 60601 1 2 The instrument is constructed such that the generation and emission of electromagnetic interference is limited so as not to disrupt the intended use of other devices while the instrument itself possesses an appropriate immunity to electromagnetic interference F2 Emitted interference standard table 1 Guidance and manufacturer s declaration electromagnetic emissions A WARNING Electrical medical devices and systems are subject to special EMC mea sures and must be installed in accordance with the EMC instructions con tained in this accompanying document Por
27. ith 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 68 mm NOTE gt 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 42 Measuring with LENSTAR APS optional WARNING The LENSTAR APS Automated Positioning System device moves autonomously during the automated measurement process To avoid trapping fingers do not touch any moving parts during the measure ment NOTE gt Make sure that the LENSTAR APS is free to move in any direction for op timum performance of the automated measurement process Before using the LENSTAR APS ensure that the cross slide fixation screw is unlocked 01 IFU_LS900 7220055 04080_eng indd 10 43 Optional T Cone 4 3 1 Fitting the optional T Cone Remove the dust cover from the storage packaging 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 A 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 lt ring of the T Cone is at the top The T Cone is held in place
28. level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 ABU 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 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 K o HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11
29. lt 3 mm 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 01020115 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 information HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 01 IFU_LS900 7220055 04080_eng indd 15 8 1 Function check zero adjustment The inspection gauge 38 supplied with the device will as FAN 38 sist the user in checking the proper functioning of the unit The type plate with the serial number can be found on the y rear of the gauge This check takes place for the first time rr when the device is commissioned Subsequent test inter ETO vals 1 week will be specified by the software message 4 displayed For e
30. nd 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 3 2 Measuring with the optional 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 cotton 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 e 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 NOTE gt 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
31. nstants 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 Ophthalmology 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 physiol
32. ogical differences in the patient cohort under treat ment on the IOL calculation HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 04 11 2014 09 43 44 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 with 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
33. pport devices standard table 4 Safe distances on non life support devices standard table 6 04 11 2014 09 43 43 1 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 SO 1 1 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 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
34. 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 HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220055 04080 8 Edition 2014 11 04 11 2014 09 43 52 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 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 Vims D 12VP 150 kHz 80 MHz Radiated RF EN 61000 4 3 3 V m 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
35. r 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 If the device repeatedly generates error messages stop using it and con tact the customer service 04 11 2014 09 43 44 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 notable difference between the right and left eye The fol lowing are classed as notable differences 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
36. scribed in the Safety chapter Improper han dling can damage the product This would void all guarantee claims e Continued use of a product damaged by incorrect handling may lead to personal injury In such a case the manufacturer will not accept any liability e Haag Streit does not grant any warranties either expressed or implied including implied warranties of merchantability or fitness for a particular use e Haag Streit expressly disclaims liability for incidental or consequential damage resulting 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 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 AS pul Manufacturer Direct current European certificate of conformity m Year of production 04 11 2014 09 43 46 Alternating current HS reference number SN Serial number P20 Housing protection Trademark of the manufacturer HS HAAG STREIT AG 2 Introduction 2 1 Basic construction The system is divided into two parts one concerned with examination LS 900 and the other with control
37. table and mobile HF communication systems may interfere with elec trical medical devices 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 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 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 01 IFU_LS900 7220055 04080_eng indd 17 17 04 11 2014 09 43 52 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
38. tware 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 the device or accessories to it are exposed to the effects of an exter nal force e g by being accidentally knocked or dropped this sensitive measuring device must be promptly checked according to section Func tion check and if necessary returned to the factory for repair 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 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 d
39. xact procedure see software instructions for use Should the test be outside the tolerance limits a software message appears and the unit must be tak en out of use Notify your HAAG STREIT customer sup port 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 Se WARNING ET 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 Always 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 15 04 11 2014 09 43 51 A Appendix C Classification A 1 Accessories spare parts C 1 LENSTAR LS 900 biometer ALI LENSTAR LS 900 EN
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