SVENSK A NEDERLANDS PORTUGUÊS ESPAÑO L ITALIANO … · flective Keratometry and Video image...

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DEUTSCH ENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊSSVENSKA

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04010 – 1. Edition / 2020 – 05

INSTRUCTIONS FOR USEBiometer

Eyestar 900® 1. Edition / 2020 – 05

1500_7220686_04010_ Gebrauchsanweisung_ES-900_01_eng.indd 11500_7220686_04010_ Gebrauchsanweisung_ES-900_01_eng.indd 1 26.03.2020 14:22:4026.03.2020 14:22:40

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDSPORTUGUÊS SVENSKA DEUTSCH ENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊSSVENSKA


INSTRUCTIONS FOR USEBiometer

Eyestar 900® 1. Edition / 2020 – 05

IntroductionThank you for choosing a Haag-Streit device. Provided you comply carefullywith the regulations in this instructions for use, we can guarantee the reliable andunproblematic 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 and patient.

NOTE!Federal law restricts this device to sale by or on the order of a physician or licensed practitioner.

Intended use The Eyestar 900 is a non-invasive, non-contact biometer used for obtaining fol-lowing information: • Corneal shapes • Axial eye length • Lens dimension and position • Anterior chamber dimensions • Front- and cross-sectional images.

IndicationsThe device indications for the use are measuring biometry data necessary for lensimplant surgeries and measuring biometry data for analyzing the anterior chamber.

ContraindicationsThere are no known contraindications.


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Contents1. Safety ..................................................................................... 41.1 Areas of application of the device .............................................................................41.2 Patient population .....................................................................................................41.3 Ambient conditions ....................................................................................................41.4 Shipment and unpacking...........................................................................................41.5 Installation warnings..................................................................................................41.6 Operation, environment.............................................................................................51.7 Plausibility of the measurements ..............................................................................61.8 IOL calculation ..........................................................................................................71.9 Optical radiation ........................................................................................................71.10 Disinfection................................................................................................................71.11 Warranty and product liability ....................................................................................71.12 Description of symbols .............................................................................................7

2. Introduction ........................................................................... 82.1 Basic construction .....................................................................................................82.2 Operating principles ..................................................................................................82.3 Eyestar 900 components ..........................................................................................82.4 Device state indicator ................................................................................................92.5 Touch screen .............................................................................................................9

3. Appliance assembly / installation ........................................ 93.1 Mains switch and power socket ................................................................................93.2 Power button .............................................................................................................93.3 LAN socket ................................................................................................................93.4 USB sockets..............................................................................................................93.5 Display port socket ....................................................................................................93.6 Headband and chin rest ............................................................................................93.7 Replacement of the headband ..................................................................................93.8 Replacement of the chin rest tray ...........................................................................10

4. Operation ............................................................................. 104.1 Position of patient during measurement..................................................................104.2 Fixation....................................................................................................................104.3 Measured variables .................................................................................................114.3.1 A-Scan ....................................................................................................................114.3.2 Keratometry ............................................................................................................114.3.3 Topography, Elevation and Pachymetry ..................................................................114.3.4 White to white distance, pupillometry and eccentricity of the visual axis ................11

5. Commissioning ....................................................................115.1 Switching on the device ..........................................................................................115.2 Switching off the device ..........................................................................................11

6. Technical data.......................................................................116.1 General data ...........................................................................................................116.2 Power ......................................................................................................................126.3 Illumination modalities .............................................................................................126.3.1 OCT light source .....................................................................................................126.3.2 Imaging system light source....................................................................................126.3.3 Primaryfixationtargets ...........................................................................................126.3.4 Felloweyefixationtarget ........................................................................................126.4 Measured variables .................................................................................................126.4.1 Central Corneal Thickness (CCT) ...........................................................................126.4.2 Anterior chamber depth (ACD) ................................................................................126.4.3 Lens thickness (LT) .................................................................................................126.4.4 Axial length (AL) ......................................................................................................126.4.5 Keratometry (K) .......................................................................................................126.4.6 Simulated Anterior Keratometry (SimK) ..................................................................126.4.7 Simulated Posterior Keratometry (SimPK) ..............................................................136.4.8 White-to-white distance (WTW) ..............................................................................136.4.9 Pupillometry (PD) ....................................................................................................136.5 Topography .............................................................................................................13

7. Software / Help menu / Error messages ........................... 138. Maintenance ........................................................................ 138.1 Cleaning ..................................................................................................................14

A. Appendix .............................................................................. 14A.1 Accessories / consumables / spare parts / upgrade ...............................................14

B. Legal regulations ................................................................ 14C. Classification ...................................................................... 14D. Disposal ............................................................................... 15E. Observed standards ........................................................... 15F. EMC supplement ................................................................ 16F.1 General ...................................................................................................................16F.2 Emitted interference (standard table 1) ...................................................................16F.3 Immunity (standard table 2) ....................................................................................17F.4 Immunity on non-life support devices (standard table 4) ........................................18F.5 Safe distances on non-life support devices (standard table 6) ...............................19


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1. SafetyDANGER!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 product and to avoid any danger to users and to patients.

NOTE!Important information: please read carefully.

1.1 Areas of application of the deviceThe Eyestar 900 is an optical non contact Biometer providing measurements and imaging of the eye from the cornea to the retina based on Swept Source OCT, re-flectiveKeratometryandVideoimageanalysistechnology.Thedeviceisintendedto use in professional health care facility environment, Iike doctor’s practices, hospi-tals and optometrists and opticians premises, except near of HF surgical equipment and RF shielded rooms of ME-systems for magnetic res onance imaging.

WARNING!• Some portable radiofrequency equipment, like cell phones or RF tele-

phone equipment including antennas may interference medical de-vices. Such equipment has to be kept in a distance of more than 30 cm (12 inches) from any part of the instrument. Inobservance of this precau-tion may lower the correct func tion of the instrument. If unexpected distur-bances are observed the cause could be a cell phone or RF telephone in the immediate vicinity to the Eyestar 900. Increase the distance to the unit until the interference disappears.

• Useofaccessories,transducersandcablesotherthanthosespecifiedorprovided by the manufacturer of this equipment could result in increased electromagnetic emission or decreased electromagnetic immunity of this equipment and result in improper operation.

1.2 Patient populationThe 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 5 years old.

1.3 Ambient conditionsTransport: Temperature

Air pressureRelative humidity

fromfromfrom

−40°C500 hPa10%

tototo

+70°C1060 hPa95%

Storage: TemperatureAir pressureRelative humidity

fromfromfrom

−10°C700 hPa 10%

tototo

+55°C1060 hPa95%

Use: TemperatureAir pressureRelative humidity

fromfromfrom

+10°C800 hPa 30%

tototo

+35°C1060 hPa90%

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 representative of the transport company.

• Leave the device in the packaging for a few hours before unpacking it (condensation).• Check the device for damage after it is unpacked.• Return defective devices in the original packaging only. If the original packaging got

damaged during shipment, replacement packing may be ordered through your local Haag-Streit representative.

• 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.• Checkthatthecontentsofthepackagingcorrespondtothecontentsspecifiedontheleafletincludedinthepackaging.

• If packed in its original packing, then the device may comply with the transport condi-tions according to ISO 15004-1.

• The device is designed for stationary use and should only be installed and moved by skilled personnel, which is familiar with the installation manual.

1.5 Installation warningsWARNING!• Grounding reliability can only be achieved when unit is connected to a

hospital grade receptacle. • The plug, cable and socket must function perfectly. The electrical connec-

tion must feature safety earth.


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• Before carrying out maintenance or cleaning work, the device must al-ways be disconnected from the mains by unplugging the power supply or plug.

• 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.).

• The device must be positioned in such a way that proper heat dispersion / ventilation is guaranteed.

• The device should be set up in such a way that the plug is always easily accessible and the device can easily be disconnected from the mains.

• The device must not be stacked or placed in close proximity to other elec-tronic devices.

1.6 Operation, environmentDANGER!• Itisnotpermittedtomakemodificationstothemeasuringdevice.• It is expressly forbidden to open the device!• Neverusethedeviceinpotentiallyexplosiveenvironmentswhereflam-

mable substances, volatile solvents (alcohol, benzene, etc.) and combus-tible anesthetics 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 familiarized with the contents of the instructions for use, especially with regard to the safety instructions contained therein.

• Measurements can be carried out with dilated or undilated pupils. Dilation ofthepupilinfluencesmeasurementofthepupildiameter(pupillometry).

• Do not place any unapproved optical elements between the device and the patient’s eye.

NOTE!• This device may only be used for the purpose described in these instruc-

tions for use.• Installation only by trained specialists.

• If EyeSuite is used on an external PC for the review and further analysis of the data acquired with the device, then the PC on which the EyeSuite software is installed may not contain any other software which could re-strict the correct operation of EyeSuite.

• Please switch the device and or external computer off if it is not to be used for a long time.

• The device may not be transported, stored, handled or operated outside thespecifiedambientconditions(seesection“Ambientconditions”).

• The device is to be used in a room in the medical area with attenuated light.

• If the device is moved/transported, a functional check must be performed in accordance with the software instructions for use.

• If the device or accessories to it are exposed to the effects of an external force (e.g., by being accidentally knocked or dropped), this sensitive mea-suring device must be promptly checked according to the software instruc-tions for use and, if necessary, returned to the factory for repair.

• 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. If the cover is not removed before switching the device on it may suffer damage due to overheating. Likewise, make sure that the device 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 oper-ating staff and patients.

• Housing parts of the device may only be removed by suitably trained and authorised specialist personnel.

• Only original spare parts and original accessories may be used for re-pairs.

• The software must be installed by trained personnel.• Measurements should only be taken with the forehead rest band and chin

rest shell mounted correctly.


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• Extensive amounts of ametropia of the patient may be corrected using glasses or trial lenses during the measurement. Contact lenses may not be used for this purpose as they would lead to inaccurate measurement results.

• The patient should be advised to open his eyelids wide during the mea-surement to allow best data acquisition.

• Unstabletearfilm,tearfilmbreakupordryeyesyndromemayleadtoin-accurateandorinstablemeasurements.Itisrecommendedtouseartifi-cial tears in such cases.

• It is recommended to set a user name and password for every user of the device to best protect sensitive patient data.

• It is recommended and is in the responsibility of the user to protect sen-sitive patient information using the access control (password protection) on the device.

1.7 Plausibility of the measurementsWARNING!• Users must check measurement readings for plausibility. This includes the

checking of the A and B-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 unusually 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.

• If the patient has previously undergone cataract surgery, available records should be consulted for plausibility check of the measurement

• 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 measure-mentsonpersonswithfixationproblems.

• In cases of thick cataracts and uncertain measurement of the axial length, ultrasound biometry should be performed as a control examination.

• 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 impos-sible to measure corneal thickness, anterior chamber depth, lens thick-ness 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-fractivesurgerybecausesucheyesmaysignificantlydeviatefromspher-ical surfaces.

• If the device repeatedly generates error messages, stop using it and con-tact the customer service. These signs must be strictly adhered to, to en-sure safe operation of the instrument and to avoid endangering users and patients.

• You are recommended to always examine both of the patient’s eyes. The user should subject the measurement readings to extra scrutiny if there is a notable difference between the right and left eye. The following are classed as notable differences:

• More than 1 D with respect to central corneal refractive power => 0.18 mm difference with respect to the corneal curvature radius

• More than 0.3 mm with respect to axial eye length• More than 1 D with respect to emmetropic IOL refractive power• The user must check the A and B-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.

• In young patients the signal from the crystalline lens might be low and measurement of the anterior chamber depth, lens thickness and aqueous depth might not be possible.

• 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 particular), and the user should check the data for plausibility.

• Ambient light has an impact on pupil-diameter measurement readings. The user is responsible for ensuring the correct level of ambient light when carrying out pupillometry. The device does not monitor ambient light, so do not use pupillometry as the decisive factor when considering kerato-refractive 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.


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• The white-to-white distance reading is merely an indirect measurement of the inner lateral dimensions of the anterior ocular section. It therefore pro-vides only approximate indications of the actual inner lateral dimensions 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 verifiedbytheuserintermsoftheirplausibility.

1.8 IOL calculationThe measurements taken with the Eyestar 900 may serve as the central element for the calculation of intraocular lenses (IOL). A further important parameter in cal-culating the lens to be implanted is the IOL constant. When using the Eyestar 900, only IOL constants optimised for optical biometers should be used. Please contact your IOL manufacturer for information on optimised IOL constants for optical biom-etry. An alternative source of information for IOL constants optimised for optical bi-ometryisthewebsiteofthe“UserGroupforLaserInterferenceBiometry”(ULIB)(http://ocusoft.de/ulib/c1.htm).DownloadableIOLConstantsfilesfortheEyestar900, featuring the ULIB IOL-Constants for the formulas implemented in EyeSuite IOL are available in the Key-User section of the Haag-Streit homepage.To further improve the clinical result, Haag-Streit recommends that every surgeon creates personally optimised IOL constants based on pre-operative measurement data generated with the Eyestar 900 and reliable postoperative data (e.g., 3 months after the operation).

1.9 Optical radiationWARNING!The light of this device may de dangerous. The risk of eye damage in-creases with the number of examinations in succession per eye. An ex-amination time with this device of over 225 individual examinations ex-ceeds the risk guideline value.

NOTE!• This device complies with the light exposure limits for class 2 ophthalmic

instruments according to EN ISO 15004-2:2007.• This instrument is a class 1 laser device in accordance with IEC 60825-1.• The device complies with the exempt (risk free) group in accordance with

IEC 62471.

1.10 DisinfectionNOTE!• The device does not need to be disinfected.• The device complies with the exempt (risk free) group in accordance with

IEC 62471:2006For more information on cleaning, please refer to the ‘Maintenance’ section.

1.11 Warranty and product liabilityHaag-Streit products must be used only for the purposes and in the manner des-cribed in the documents distributed with the product. The product must be treated as described in the ‘Safety’ chapter. Improper hand-ling can damage the product. This would void all guarantee claims. 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.Haag-Streit does not grant any warranties, either expressed or implied, including implied warranties of merchantability or fitness for a particular use.Haag-Streit expressly disclaims liability for incidental or consequential damage resulting from the use of the product.This product is covered by a limited warranty granted by your seller.

This product is covered by a limited warranty, which may be reviewed at www.haag-streit-usa.com.

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•

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•

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•For USA only:•

1.12 Description of symbols

Follow instruction for use Read the instructions for useattentively

General warning: Read the ac-companying documentation

Notes on disposal, see the'Disposal' chapter

European certificate of conformity

MET Listed Mark with approval for USA and Canada

Date of manufacture Manufacturer

Disconnect the plug before opening the device Warning for laser beam


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Type B applied part Housing protection

Alternating current Direct current

Serial number HS reference number

Trademark of the manufacturer Haag-Streit AG

2. Introduction2.1 Basic constructionThe Eyestar 900 is an all in one optical biometry device, containing a measuring head and internal computer for signal processing and display of results. The unit is operated via a touch screen interface and some buttons at the device housing. Eye-Suite is the software that runs the unit and is pre-installed on the built in computer. Integral, automatic error recognition for the measurements guarantees reliable ex-amination results.

2.2 Operating principlesThe Eyestar 900 is a non-contact device consisting of a swept source OCT sub-unit (OCT: optical coherence tomography, a measurement method to acquire tomo-graphic images by optical interferometry) and an imaging system sub-unit.The OCT sub-unit performs a three-dimensional measurement of all refractive oc-ular structures in the anterior eye segment (curvatures and locations of anterior cor-neal surface, posterior corneal surface, anterior crystalline lens surface, posterior crystalline lens surface), as well as a one-dimensional measurement of axial eye length. It also generates cross-sectional images of the anterior eye section and the central retina. The measurement is implemented by scanning the eye with a low-powernear-infraredlaserbeamandmeasuringthelightwhichisback-reflectedtothe device. The imaging system sub-unit is used to obtain photographic images of the eye. Based on these images, the white-to-white distance and the pupil diam-eter are measured. Additionally, these images can serve to document the locations of special landmarks on the eye, such as blood vessels. Illumination for imaging is provided by infrared and white-light LEDs (light emitting diodes).

2.3 Eyestar 900 components1. Forehead rest band

(applied part, removable part)2. Front illumination (5 pieces)3. Ocular (left and right)4. Height adjustable chin rest

(applied part, removable part)5. Hand grips for patient (applied part)6. Multifunction buttons7. Ventilationgroove8. Device state indicator9. Touch screen

10. Display port socket11. LAN port socket (Gigabit)12. USB port sockets

(2 × USB 2.0 / 2 × USB 3.0)13. Mains switch14. Fuses(2×T2AH,250V)15. Mains socket16. Type Plate17. Power button18. Connector panel cover

1

2

3

4

5

7

8

9

6

11 1210

1617

13 14 15


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1817

2.4 Device state indicatorThe device state indicator allows device monitoring without PC software:State indicator Dark Device is turned off

Pulsing orange StandbyGreen On no measurement in processBlue Light source is on for measurementRed Device error

2.5 Touch screenThe touch screen panel is mounted in the right side from the patient’s point of view as a default location. I may also be mounted on the rear of the device or on the left. Adjustments of the screen location must be carried out by trained service personnel only.

3. Appliance assembly / installationWARNING!• The device must be installed by trained personnel in accordance with

the installation instructions provided in the separate service installation manual.

• Whenever the Eyestar 900 is connected to any external electronic device, thentheuserhastoensurethattheconfigurationisinaccordancewithsafety regulations according to EN 60601-1. This may be achieved by e.g. use of a medical grade insulation transformer or a medical grade power supply to power the external screen.

• For further information, please contact your Haag-Streit representative.

3.1 Mains switch and power socketThe mains connector of the Eyestar 900 is a C 13 Socket. It is located under the device and allows invisible cable management if the device is used on a table (op-tional) that features a respective aperture for the mains and other cables (e.g. LAN).

Use the mains switch to turn the device off if it is not used for a longer time period or if the device is covered with the optional dust cover, to prevent accidental power up and possible overheating. The integral power supply works with the voltages spec-ifiedundersection6.2“Power”.Itisnotnecessarytoselectthevoltageonthede-vice.

3.2 Power buttonThe power button is used to switch the device from standby to on and back to stand by if the mains cable is connected and the mains switch is turned on. The status in-dicator informs the user on the current state of the device.

3.3 LAN socketThe LAN socket enables the Eyestar 900 to be connected to a local area network. This is used to run the Eyestar 900 in a DICOM or EMR environment or to access an external EyeSuite database enabling the assessment of measurements on PC viewing stations with an EyeSuite installation. For more details on the network and EMR integration capabilities of the device, check the EyeSuite software instructions for use accessible in the software.

3.4 USB socketsThe Eyestar 900 features four (4) USB sockets, two features USB 2.0 and two fea-tures USB 3.0 standard. They may be used to connect an external hard drive to the deviceforbackupofdataortoimporte.g.IOLdefinitionfilesfromamemorystick.They may also be used to connect an optional keyboard and / or mouse and to con-nect to a printer. For more information how to install a printer on the device, check the EyeSuite software instructions for use accessible in the software.

3.5 Display port socketEyestar 900 also features a display port socket. This enables the user to display the Eyestar 900’s user interface on a 2nd external screen.

3.6 Headband and chin restFor cleaning and periodical exchange, the headband as well as the chin rest may be removed from the device. It is recommended to replace either part if it shows physical damage to the surface and edge or if they have been in use for more than two years.

3.7 Replacement of the headbandThe headband is held in place with a click / slide mechanism. To remove it, push in the middle of the headband and pull on the left edge of the headband to loosen the


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The patient should sit upright, in a relaxed position. Adjust the height of the instru-ment table and chair of the patient to allow a relaxed lightly downwards directed gaze position. The height adjustment of the chin rest is performed via the touch screen user interface or the two arrow-multifunction buttons on top of the device. Additional height indication marks at the device cover representing the eye height level and may help position the chin rest in a good initial position. Details on the measurement process are described in the software instructions for use of the de-vice.

WARNING!• Always check the chosen measure mode and patient settings.• Do not place any unapproved optical elements between the device and

the patient’s eye.• The motorized chin rest may pose a crushing hazard.

NOTE!In order to get the best possible results, the patient should be re-quested to keep the eye as wide open as possible during the measure-mentandtofocusonthefixationtarget.Themeasurementstartswhenthefixationtargetchangesitscolorfromgreentoblue.Themeasure-mentisfinishedwhenthefixationtargetturnsgreenagain.Blinkingispermitted throughout the measurement process, but should be kept to a minimum.Patients with tremor might be assisted by the user or a third person in holding their head still.

4.2 FixationToobtainreliableresults,thepatientmuststareatthemulti-colorfixationlightinthemeasuring lens during measurement.

slide mechanism. After the left side is loose, pull on the left edge to unclick it from its mount on the device.Cleantheheadbandasdescribedinsection8.1“Cleaning”.Tomounttheheadbandagain,firstclickitinontherightsidethenslideitbackinon the left

3.8 Replacement of the chin rest trayGraspthechinresttray(blackplasticpart)withyourthumbandindexfinger.Nowpull it towards you. The tray will slide from the metal chin rest mechanism on the de-vice.Cleanthechinresttrayasdescribedinsection8.1“Cleaning”.To mount the chin rest tray again slide it back on the metal chin rest mechanism until you may not pull it further in.

4. Operation4.1 Position of patient during measurement

NOTE!Prior to the measurement procedure, clean the patient interface fore-head rest band, chin rest shell and both handles including their sup-portingpartsasdescribedinsection8.1“Cleaning”.

A steady head position is promoted by resting the patient’s head in good contact with the chin rest and forehead rest band, and by the patient holding on to the hand grips.Thiscanpositivelyinfluenceadjustmenttimeandmeasuringaccuracy.


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4.3 Measured variables4.3.1 A-ScanDependingonthepatient’sgazeatthefixationlight,theopticalpathlengthofthevi-sual axis is measured:CCT Central corneal thickness

ADCCT

ACD

ALLT

AD Aqueous depth (Back of the cornea to front of the lens)

ACD Anterior chamber depthLT Lens thicknessAL Axial eye length (Front of the cornea to inner

limiting membrane)

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).

4.3.2 Keratometry Thevaluesdisplayed(flatradius,steepradius)correspondtotheradiiofanellipsoidthatfitsintothecornea.Theaxisof its rotation is measured counter-clockwise from the hori-zontaltotheflatradius.

• e: Flat radius• f: Steep radius• g: Axis of rotation

4.3.3 Topography, Elevation and PachymetryThe device provides the user with surface information of the cornea in the following formats:• Anterior and posterior axial curvature map• Anterior and posterior tangential curvature map• Total corneal power map• Anterior and posterior elevation map• Anterior and posterior irregularity map• Pachymetry map

4.3.4 White to white distance, pupillometry and eccentricity of the visual axisThe 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.

WTW

Pupil diameter (Ø) 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 vi-sual 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.

5. CommissioningThe device is powered though an integrated medical grade power supply, it works withthevoltagesspecifiedundersection6.2“Power”.Itisnotnecessarytoselectthe voltage on the device. Ensure that the power cable used always features the safety earth pin and that the respective pin is functional on the socked used.

5.1 Switching on the device• Connect the power plug to the mains.• Switch on the main switch.• Start the device by pressing the stand-by / on button.

5.2 Switching off the device• Exit the software on the device or press the stand-by / on button for more than 3 sec-

onds.• Only switch of the main switch after the internal computer was shut down and the

screen is blank.• Disconnect the power from the mains if you do not intend to use the device for an ex-

tended period of time.

6. Technical data6.1 General dataType designation: Eyestar ES 900Dimensions: 480 × 560 × 460 mmWeight: 31.0 kg


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6.2 PowerInput: 100–240VAC,50–60Hz,200VA

6.3 Illumination modalities6.3.1 OCT light sourceLight source: Wavelength tunable laserWavelength range: 1030 nm … 1080 nmPower on patient’s eye ≤2.0mW

6.3.2 Imaging system light sourceLight source: Infrared- and warm white LEDsWavelength: 850 nm (IR)

warm white

6.3.3 PrimaryfixationtargetsLight source: LEDsWavelengths: 525 nm (green)

624 nm (red)

6.3.4 FelloweyefixationtargetLight source: LEDsWavelengths: 625 nm (red)

850 nm (IR)

6.4 Measured variablesReported in-vivo repeatabilities are based on N=46 eyes (one eye per subject). 32 phakic (healthy and cataract) and 14 pseudophakic eyes were included. In-vivo re-peatability is calculated as the standard deviation of pairwise differences of three re-peatedmeasurementspereyeforalleyes.Aphakicandoil-filledeyescanbemea-sured with the device. The reported in vivo repeatability does not include these eye types.

6.4.1 Central Corneal Thickness (CCT)Measurement range: 300 - 800 µmDisplay resolution: 1 µmIn vivo repeatability (1. SD): ± 1.5 µm

6.4.2 Anterior chamber depth (ACD)Measurement range: 1.8 - 6.3 mmDisplay resolution: 0.01 mmIn vivo repeatability (1. SD): ± 0.014 mm

6.4.3 Lens thickness (LT)Measurement range: 0.5 - 6.5 mmDisplay resolution: 0.01 mmIn vivo repeatability (1. SD): ± 0.015 mm

6.4.4 Axial length (AL)Measurement range: 14 - 38 mmDisplay resolution: 0.01 mmIn vivo repeatability (1. SD): ± 0.005 mm

6.4.5 Keratometry (K)Measurement range K: 32.1 - 67.5 dptDisplay resolution K: 0.01 dptIn vivo repeatability Kmean (1. SD): ± 0.067 dptIn vivo repeatability AST (1. SD): ± 0.127 dptMeasurement range Axis: 0 - 180°Display resolution Axis: 1°In vivo repeatability Axis, 0.5dpt<AST≤1.5dpt(1.SD):

± 4.5°

In vivo repeatability Axis, AST > 1.5 dpt (1. SD): ± 1.6°

6.4.6 Simulated Anterior Keratometry (SimK)Measurement range SimK: 32.1 - 67.5 dptDisplay resolution SimK: 0.01 dptIn vivo repeatability SimKmean (1. SD): ± 0.247 dptIn vivo repeatability SimAST (1. SD): ± 0.125 dptMeasurement range SimAxis: 0 - 180°Display resolution SimAxis: 1°


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In vivo repeatability SimAxis, 0.5dpt<AST≤1.5dpt(1.SD):

± 3.8°

In vivo repeatability SimAxis, AST > 1.5 dpt (1. SD):

± 1.8°

Display resolution Corneal Shape Factor: 0.01In vivo repeatability Corneal Shape Factor: 0.10

6.4.7 Simulated Posterior Keratometry (SimPK)Measurement range SimPK: 3.9 - 9.5 dptDisplay resolution SimPK: 0.01 dptIn vivo repeatability SimPKmean (1. SD): ± 0.048 dptIn vivo repeatability SimPAST (1. SD): ± 0.028 dptMeasurement range SimPAxis: 0 - 180°Display resolution SimPAxis: 1°Display resolution Posterior Corneal Shape Factor:

0.01

In vivo repeatability Posterior Corneal Shape Factor:

0.11

6.4.8 White-to-white distance (WTW)Measurement range: 7 - 16 mmDisplay resolution: 0.01 mmIn vivo repeatability (1. SD): ± 0.079 mm

6.4.9 Pupillometry (PD)Measurement range: 2 - 13 mmDisplay resolution: 0.01 mm

6.5 TopographyCovered area (diameter): 7.5 mm

In-vivo repeatability:This repeatability table is based on N=46 eyes (32 phakic (healthy and cataract) and 14 pseudophakic eyes, one eye per subject) with three measurements per eye.

Measurand AreaCenter zone Middle zone Outer zone

Mean1) 2 Std. Dev.2)

Mean 2 Std. Dev.

Mean 2 Std.Dev.

Anterior corneal curvature dpt 0.218 0.312 0.101 0.282 0.118 0.294Posterior corneal curvature dpt 0.041 0.048 0.016 0.056 0.034 0.066Anterior elevation µm N/A 1.2 N/A 2.6 N/A 4.6Posterior elevation µm N/A 2.0 N/A 4.8 N/A 9.6Pachymetry µm N/A 1.4 N/A 3.4 N/A 5.2

Unit

Areasindicatethecenterzone(diameter≤3mm),middlezone(3mm<diameter≤6mm) and outer zone (diameter > 6mm) regions of the cornea.1) Mean: Standard deviation of the mean difference between paired data sets.2) 2 Std. Dev.: Twice the mean of the standard deviation of differences between paired data sets.Normative considerations:Eyestar 900 complies with the standard EN ISO 19980:2012 for corneal topography systems, type A.

7. Software / Help menu / Error messagesThe 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. For further information, please contact your Haag-Streit representative.

NOTE!• The instructions for use is integrated into the software. • Error messages are described in the software instructions for use.

8. MaintenanceThe Eyestar 900 is practically maintenance-free and requires only minimum care to work for as long as possible to your complete satisfaction. However, we recommend instructing a service engineer to inspect the biometer periodically. Haag-Streit or your local representative will be happy to provide further information.


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8.1 CleaningThe cleaning intervals for cleaning the complete device shall be performed within reasonable time (e.g. once a week). Cleaning of applied parts shall be performedprior to the measurement procedure with a new patient.Please use only following tools for cleaning operations:• Cleaning liquid: Isopropanol 2 (cleaning liquid with maximum 70 % alcohol)• Cover towel: commercially available towel• Display towel: commercially available towel for cleaning screens• HS Lenspen (see appendix)In particular, attention has to be paid to the following points:• Only use cleaning liquid evenly spread on the cover towel on following device parts:• Patient interface chin rest shell including its supporting parts• Patient interface forehead rest band including its supporting parts• Patient interface handles including their supporting parts• Device cover (casing)• User interface display panel• User interface display panel surroundings and standThe device patient interface cover glasses shall only be cleaned with the HS Lens- pen.

WARNING!Only perform maintenance on a powered off device.

We suggest following cleaning procedure:• Put cleaning liquid evenly spread on the cover towel• Clean the patient interface forehead rest band, chin rest shell and both handles in-

cluding their supporting parts with the cover towel• Put cleaning liquid evenly spread on the cover towel• Clean the complete device cover with the cover towel• Put cleaning liquid evenly spread on the cover towel• Clean the display panel surroundings and stand with the cover towel• Clean the display panel (control panel) with the display towel• Clean the patient interface cover glasses with the HS Lenspen with the felt and the

brush• Protect the device from dust with the dedicated accessory dust cover when the de-

vice is not in use.

WARNING!Thedevicemustnotbeswitchedonwhencovered!(Heatbuild-up,firehazard).

A. AppendixA.1 Accessories / consumables / spare parts / upgradeComponent REFChin rest shell 1022709Forehead rest band 1022903Cable Power Inlet Adapter 1023026Packaging 1023037Dust Protection Cover 1802304HS Lenspen 1820415

B. Legal regulations• 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’.

• This is a Class IIa device in accordance with Appendix IX of Directive 93/42/EEC. By affixingtheCEmarkweconfirmthatourdevicecomplieswiththeapplicablestan-dards and directives.

• You can request a copy of the declaration of conformity for the device from Haag-Streit at any time.

C. ClassificationEN 60601-1:2006+A1:2013/AN Continuous operationEN 60825-1:2014 Laser class IEN 60529:1991+A1:2000 Enclosure protection IP20EN 62471:2008 Exempt groupEN ISO 15004-2:2007 Group 2ISO 19980:2012 Corneal topographer, type A93/42/EEC (medical devices) Class IIa


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D. DisposalElectrical and electronic devices must be disposed of separately fromhousehold waste! This appliance was made available for sale after the13th 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.

E. Observed standardsEN 60601-1 EN 60529EN 60601-1-2 EN ISO 15004-1EN 62471 EN ISO 15004-2EN 60825-1 EN ISO 19980


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F. EMC supplement F.1 GeneralThe Eyestar 900 complies with the standard EN 60601-1-2:2015 (IEC 4th Edition). The instrument is constructed such that the generation and emission of electromag-netic interference is limited so as not to disrupt the intended use of other devices, while the instrument itself possesses an appropriate immunity to electromagnetic in-terference.

F.2 Emitted interference (standard table 1)The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition) and EN 60601-1-2:2015 (IEC 4th edition).

Guidance and manufacturer's declaration – electromagnetic emissionsThis product is intended for use in the electromagnetic environment specifi ed 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 - guidanceRF 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

the public low-voltage power supply network that supplies buildings used for domestic purposes.Emission of harmonics according to EN 61000-3-2

Class 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.

• Portable 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 Eyestar 900 bi-ometer system.


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F.3 Immunity (standard table 2)The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).

Guidance and manufacturer's declaration – electromagnetic immunityThis product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-ronment.Immunity test standard EN 60601 test level Compliance level Electromagnetic environment – guidanceElectrostatic discharge (ESD) EN 61000-4-2

± 8 kV contact± 15 kV air

± 8 kV contact± 15 kVair

Floors should be wood, concrete or ceramic tile. If floors arecovered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient / burst EN 61000-4-4

± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment.

Surge EN 61000-4-5

± 1 kV for symmetrical voltages± 2 kV for asymmetrical voltages

± 1 kV for symmetrical voltages± 2 kV for asymmetrical voltages

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply linesEN 61000-4-11

< 5% UT (> 95% drop in UT)for ½ cycle< 40% UT (> 60% drop in UT)for 5 cycles< 70% UT (> 30% drop in UT)for 25 cycles< 5% UT (> 95% drop in UT) for 5 s

< 5% UT (> 95% drop in UT)for ½ cycle< 40% UT (> 60% drop in UT)for 5 cycles< 70% UT (> 30% drop in UT)for 25 cycles< 5% UT (> 95% drop in UT) for 5 s

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 (50/60Hz)magnetic fi eld EN 61000-4-8

30 A/m Power frequency magnetic fi elds should be at levels char-acteristic of a typical location in a typical commercial or hos-pital environment.

NOTE: UT= the AC mains voltage prior to application of the test level.

30 A/m


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F.4 Immunity on non-life support devices (standard table 4)The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).

Guidance and manufacturer's declaration – electromagnetic immunityThis product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-ronment.Electromagnetic environment – guidancePortable 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(c):Conducted RF EN 61000-4-6 3 Vrms

150 kHz – 80 MHz5 Vrms D = 0.7

Radiated RF EN 61000-4-3 3 V/m80 MHz – 2.7 GHz

5 V/m80 MHz – 6 GHz

D = 1.2 80 MHz – 800 MHzD = 2.3 800 MHz – 6 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation distance in meters (m). Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbolNOTE 1: At 80 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 fi xed 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 fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld 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.c.

Over the frequency range 150 kHz to 80 MHz, Possible shorter distances outside the ISM bands do not contribute to improved application in this table.

fi eld strengths should be less than 5 Veff.


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F.5 Safe distances on non-life support devices (standard table 6)The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).

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.

Nominal output of the transmitter (W)

Safe distance according to transmission frequency (m)150 kHz – 80 MHz

D = 0.35 80 MHz – 800 MHz

D = 0.7 800 MHz – 2.7 GHz

D = 1.4 0.010.11

10100

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)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 2.7 GHz an additional factor of 10/3 was used to reduce the

probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area.These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.NOTE 3:

0.0350.1

0.351.13.5

0.070.20.72.27

0.140.441.44.414


0297

http://www.haag-streit.com/contact/contact-your-distributor.html

HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, SwitzerlandPhone +41 31 978 01 11Fax +41 31 978 02 82eMail [email protected] www.haag-streit.com

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