Haag-Streit Eyestar 900 User manual

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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
INSTRUCTIONS FOR USE
Biometer
EYESTAR 900¨
2. Edition / 2021 – 05

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
INSTRUCTIONS FOR USE
Biometer
EYESTAR 900¨
2. Edition / 2021 – 05
Introduction
Thank you for choosing a Haag-Streit device. Provided you comply carefully 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 product.
It contains important information regarding the safety of the user and
patient.
NOTE!
For USA only: Federal law restricts this device to sale by or on the order
of a physician or licensed practitioner.
Intended purpose
The EYESTAR 900 is a non-invasive, non-contact biometer used for obtaining
following information:
• Corneal shapes
• Axial eye length
• Lens dimension and position
• Anterior chamber dimensions
• Front- and cross-sectional images.
The device indications for the use are measuring biometry data necessary for lens
implant surgeries and measuring biometry data for analyzing the anterior chamber.
Contraindication
There are no known contraindications.

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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
Contents
¥ 1 Safety...................................................................................................................................................4
◦ 1.1 Areas of application of the device..................................................................................................4
◦ 1.2 Patient population ..........................................................................................................................4
◦ 1.3 Ambient conditions.........................................................................................................................4
◦ 1.4 Shipment and unpacking ...............................................................................................................4
◦ 1.5 Installation warnings ......................................................................................................................5
◦ 1.6 Operation, environment .................................................................................................................5
◦ 1.7 Plausibility of the measurements ...................................................................................................6
◦ 1.8 IOL calculation ...............................................................................................................................8
◦ 1.9 Optical radiation.............................................................................................................................8
◦ 1.10 Disinfection ..................................................................................................................................8
◦ 1.11 Warranty and product liability.......................................................................................................8
◦ 1.12 Description of symbols.................................................................................................................8
¥ 2 Introduction .....................................................................................................................................9
◦ 2.1 Basic construction..........................................................................................................................9
◦ 2.2 Operating principles.......................................................................................................................9
◦ 2.3 Eyestar 900 components ...............................................................................................................9
◦ 2.4 Device state indicator...................................................................................................................10
◦ 2.5 Touch screen ...............................................................................................................................10
¥ 3 Device assembly / installation ...........................................................................................10
◦ 3.1 Mains switch and power socket ...................................................................................................11
◦ 3.2 Power button................................................................................................................................11
◦ 3.3 LAN socket...................................................................................................................................11
◦ 3.4 USB sockets ................................................................................................................................11
◦ 3.5 Display port socket.......................................................................................................................11
◦ 3.6 Headband and chin rest...............................................................................................................11
◦ 3.7 Replacement of the headband.....................................................................................................11
◦ 3.8 Replacement of the chin rest tray ................................................................................................12
¥ 4 Operation.........................................................................................................................................12
◦ 4.1 Position of patient during measurement ......................................................................................12
◦ 4.2 Fixation ........................................................................................................................................12
◦ 4.3 Measured variables......................................................................................................................12
▪ 4.3.1 A-Scan..............................................................................................................................12
▪ 4.3.2 Keratometry ......................................................................................................................13
▪ 4.3.3 Topography, Elevation and Pachymetry...........................................................................13
▪ 4.3.4 White to white distance, pupillometry and eccentricity of the visual axis..........................13
¥ 5 Commissioning ...........................................................................................................................13
◦ 5.1 Switching on the device ...............................................................................................................13
◦ 5.2 Switching off the device ...............................................................................................................13
¥ 6 Technical data..............................................................................................................................14
◦ 6.1 General data ................................................................................................................................14
◦ 6.2 Power...........................................................................................................................................14
◦ 6.3 Illumination modalities .................................................................................................................14
▪ 6.3.1 OCT light source ..............................................................................................................14
▪ 6.3.2 Imaging system light source............................................................................................. 14
▪ 6.3.3 Primary fixation target ......................................................................................................14
▪ 6.3.4 Fellow eye fixation target.................................................................................................. 14
◦ 6.4 Measured variables .....................................................................................................................14
▪ 6.4.1 Central Corneal Thickness (CCT) ....................................................................................14
▪ 6.4.2 Anterior chamber depth (ACD)......................................................................................... 14
▪ 6.4.3 Lens thickness (LT).......................................................................................................... 14
▪ 6.4.4 Axial length (AL)............................................................................................................... 15
▪ 6.4.5 Keratometry (K)................................................................................................................ 15
▪ 6.4.6 White-to-white distance (WTW)........................................................................................ 15
▪ 6.4.7 Pupillometry (PD) .............................................................................................................15
◦ 6.5 Topography ................................................................................................................................. 15
▪ 6.5.1 Invivo repeatability standard topography (7.5 mm diameter) ...........................................15
▪ 6.5.2 Simulated Anterior Keratometry (SimK), standard topography (7.5 mm diameter).......... 16
▪ 6.5.3 Simulated Posterior Keratometry (SimPK), standard topography (7.5 mm diameter)...... 16
▪ 6.5.4 Invivo repeatability extended topography (12 mm diameter) ...........................................16
▪ 6.5.5 Simulated Anterior Keratometry (SimEK), extended topography (12 mm diameter)........ 17
▪ 6.5.6 Simulated Posterior Keratometry (SimEPK), extended topography (12 mm diameter) ...17
▪ 6.5.7 Normative considerations:................................................................................................ 17
▪ 6.5.8 Cristalline lens tilt .............................................................................................................17
¥ 7 Software / Help menu / Error messages...................................................................... 17
¥ 8 Maintenance.................................................................................................................................. 18
◦ 8.1 Cleaning ...................................................................................................................................... 18
¥ 9 Appendix......................................................................................................................................... 18
◦ 9.1 Accessories / consumables / spare parts / upgrade.................................................................... 18
◦ 9.2 Legal regulations .........................................................................................................................19
◦ 9.3 Classification ............................................................................................................................... 19
◦ 9.4 Disposal....................................................................................................................................... 19
◦ 9.5 Observed standards ....................................................................................................................19
◦ 9.6 Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) ...19
▪ 9.6.1 General............................................................................................................................. 19
▪ 9.6.2 Emitted interference ......................................................................................................... 20
▪ 9.6.3 Electromagnetic immunity environment tested (part 1).................................................... 21
▪ 9.6.4 Electromagnetic immunity environment tested (part 2).................................................... 22
▪ 9.6.5 Recommended separation distances between portable and mobile RF communications
equipment and this product....................................................................................................... 24

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
1Safety
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 product and to avoid any danger to users and to
patients.
NOTE!
Important information: Please read carefully.
1.1 Areas of application of the device
The 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,
reflective Keratometry and Video image analysis technology. This device is intended
to be used in professional health care facilities such as hospitals, physician's,
optometrist's and optician's practices. For optimal use of the device, the ambient
lighting should be attenuated.
WARNING!
• This device must not be operated near of high frequency surgical
equipment and the radio frequency shielded room of a medical
electrical system for magnetic resonance imaging, where the
intensity of electromagnetic disturbances is high.
• Portable radio frequency communications equipment (including
peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the device,
including cables specified by Haag-Streit. Otherwise, degradation of
the performance of this device could result.
• If unexpected disturbances are observed the cause could be a cell
phone or radio frequency telephone in the immediate vicinity to the
Eyestar 900. Increase the distance to the device until the
interference disappears.
• Use of accessories, transducers and cables other than those
specified or provided by Haag-Streit could result in increased
electromagnetic emission or decreased electromagnetic immunity of
this device and result in improper operation.
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 following
the examination. Patients must be at least 6 years old.
1.3 Ambient conditions
Temperature −40 °C ... +70 °C
Air pressure 500 hPa ... 1060 hPa
Transport
Relative humidity 10 % ... 95 %
Temperature −10 °C ... +55 °C
Air pressure 700 hPa ... 1060 hPa
Storage
Relative humidity 10 % ... 95 %
Temperature +10 °C ... +35 °C
Air pressure 800 hPa ... 1060 hPa
Use
Relative humidity 30 % ... 90 %
1.4 Shipment and unpacking
• Before unpacking the device, check whether the packaging shows traces of
improper handling or damage. If this is the case, notify the transport company
that delivered the goods to you. Unpack the equipment together with a
representative of the transport company. Make a report of any damaged parts.
This report must be signed by you and by the representative of the transport
company.

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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
• 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.
• Check that the contents of the packaging correspond to the contents specified
on the leaflet included in the packaging.
• If packed in its original packing, then the device may comply with the transport
conditions 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 warnings
WARNING!
• 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
connection must feature safety earth.
• Before carrying out maintenance or cleaning work, the device must
always 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 external 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.
• Use of this device adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this device and the other equipment should
be observed to verify that they are operating normally.
1.6 Operation, environment
DANGER!
• It is not permitted to make modifications to the measuring device.
• It is expressly forbidden to open the device!
• Never use the device in potentially explosive environments where
flammable substances, volatile solvents (alcohol, benzene, etc.) and
combustible 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 instructions 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 of the pupil influences measurement of the pupil diameter
(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
instructions for use.
• Installation only by trained specialists.

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
•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 restrict 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 the specified ambient conditions (see chapter 'Ambient
conditions').
• 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 measuring device must be promptly checked according to
the software instructions for use and, if necessary, returned to the
factory for repair.
• The selected measuring mode must be checked before every
measurement.
• 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 unauthorised 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
specialist personnel. Incorrect repairs can pose considerable risks
for operating 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
repairs.
• The software must be installed by trained personnel.
• Measurements should only be taken with the forehead rest band
and chin rest shell mounted correctly.
•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
measurement to allow best data acquisition.
• Unstable tear film, tear film breakup or dry eye syndrome may lead
to inaccurate and or instable measurements. It is recommended to
use artificial 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
sensitive patient information using the access control (password
protection) on the device.
1.7 Plausibility of the measurements
WARNING!
• 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.

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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
• 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
measurements 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
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
impossible to measure corneal thickness, anterior chamber depth,
lens thickness or axial eye length.
• Blood in the vitreous may make it impossible to measure the axial
eye length.
• Keratometry may be erroneous in eyes that have undergone
keratorefractive surgery because such eyes may significantly
deviate from spherical surfaces.
• If the device repeatedly generates error messages, stop using it and
contact the customer service. These signs must be strictly adhered
to, to ensure safe operation of the device 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. Uncertainty in this case can lead to the displayed reading
for anterior chamber depth being inaccurate by the thickness of the
IOL (approx. ±1 mm).
• The measured corneal thickness is not intended as a basis for the
correction of intraocular pressure readings for diagnosing glaucoma.
• An excessively tilted or decentered IOL may make it impossible to
measure 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.
• The white-to-white distance reading is merely an indirect
measurement of the inner lateral dimensions of the anterior ocular
section. It therefore provides only approximate indications of the
actual inner lateral dimensions of the anterior ocular section and of
the size of the implant used.

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• The measured results of patients with asteroid hyalosis may not be
accurate (in particular the axial length measurement) and must
therefore be verified by the user in terms of their plausibility.
1.8 IOL calculation
The measurements taken with the Eyestar 900 may serve as the central element for
the calculation of intraocular lenses (IOL). A further important parameter in
calculating 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
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)
(http://ocusoft.de/ulib/c1.htm). Downloadable IOL Constants files for the Eyestar
900, 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 radiation
WARNING!
The light of this device may de dangerous. The risk of eye damage
increases with the number of examinations in succession per eye. An
examination time with this device of over 225 individual examinations
exceeds the risk guideline value.
NOTE!
• This device complies with the light exposure limits for class 2
ophthalmic devices according to EN ISO 15004-2:2007.
•This device 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 Disinfection
NOTE!
• The device does not need to be disinfected.
• The device complies with the exempt (risk free) group in accordance
with IEC 62471:2006
For more information on cleaning, please refer to the ‘Maintenance’ chapter.
1.11 Warranty and product liability
• Haag-Streit products must be used only for the purposes and in the manner
described in the documents distributed with the product.
• The product must be treated as described in the ‘Safety’ chapter. Improper
handling 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.
For USA only:
• This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
1.12 Description of symbols
Follow instruction for use Read the instructions for use
attentively
General warning: Read the
accompanying documentation
European certificate of
conformity
Date of manufacture Manufacturer

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
HS reference number Serial number
Trademark of the manufacturer
Haag-Streit AG
Notes on disposal, see the
'Disposal' chapter
Listed European Authorized
Representative Medical Device
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
MET Listed Mark with approval
for USA and Canada
Disconnect the plug before
opening the device Warning for laser beam
Type B applied part Housing protection
Alternating current Direct current
2Introduction
2.1 Basic construction
The 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.
EyeSuite 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 examination results.
2.2 Operating principles
The Eyestar 900 is a non-contact device consisting of a swept source OCT subunit
(OCT: optical coherence tomography, a measurement method to acquire
tomographic images by optical interferometry) and an imaging system sub-unit.
The OCT sub-unit performs a three-dimensional measurement of all refractive
ocular structures in the anterior eye segment (curvatures and locations of anterior
corneal 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
lowpower near-infrared laser beam and measuring the light which is back-reflected
to the 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 diameter
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 components
1. 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 buttons
7. Ventilation groove
8. Device state indicator
9. Touch screen
10. Display port socket
11. LAN port socket (Gigabit)
12. USB port sockets (2 × USB 2.0 / 2
× USB 3.0)
13. Mains switch
14. Fuses (2 × T2AH, 250V)
15. Mains socket
16. Type Plate
17. Power button
18. Connector panel cover

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2.4 Device state indicator
The device state indicator allows device monitoring without PC software:
State indicator Dark Device is turned off
Pulsing orange Standby
Green On, no measurement in process
Blue Light source is on for measurement
Red Device error
2.5 Touch screen
The 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 Device assembly / installation
WARNING!
• 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, then the user has to ensure that the configuration is in
accordance with safety regulations according to EN 60601-1. This