Haag-streit Eyestar 900 User manual

DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS

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INSTRUCTIONS FOR USE

Biometer

EYESTAR 900¨

2. Edition / 2021 – 05

DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS

PORTUGUÊS SVENSKA

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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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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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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• 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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•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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• 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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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

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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 socket

The 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

(optional) 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 specified under chapter 6.2 'Power'. It is not necessary to select the voltage

on the device.

3.2 Power button

The 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

indicator informs the user on the current state of the device.

3.3 LAN socket

The 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 sockets

The Eyestar 900 features four (4) USB sockets, two features USB 2.0 and two

features USB 3.0 standard. They may be used to connect an external hard drive to

the device for backup of data or to import e.g. IOL definition files from a memory

stick. They may also be used to connect an optional keyboard and / or mouse and to

connect 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 socket

Eyestar 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 rest

For 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 headband

The 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

slide mechanism. After the left side is loose, pull on the left edge to unclick it from its

mount on the device.

Clean the headband as described in chapter 8.1 'Cleaning'.

To mount the headband again, first click it in on the right side then slide it back in on

the left.

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3.8 Replacement of the chin rest tray

Grasp the chin rest tray (black plastic part) with your thumb and index finger. Now

pull it towards you. The tray will slide from the metal chin rest mechanism on the

device. Clean the chin rest tray as described in chapter 8.1 '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.

4Operation

4.1 Position of patient during measurement

NOTE!

Prior to the measurement procedure, clean the patient interface

forehead rest band, chin rest shell and both handles including their

supporting parts as described in chapter 8.1 '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. This can positively influence adjustment time and measuring accuracy.

The patient should sit upright, in a relaxed position. Adjust the height of the

instrument 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

device.

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 requested

to keep the eye as wide open as possible during the measurement and

to focus on the fixation target. The measurement starts when the fixation

target changes its color from green to blue. The measurement is

finished when the fixation target turns green again. Blinking is permitted

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 Fixation

To obtain reliable results, the patient must stare at the multi-color fixation target in

the measuring lens during measurement.

4.3 Measured variables

4.3.1 A-Scan

Depending on the patient’s gaze at the fixation target, the optical path length of the

visual axis is measured:

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CCT Central corneal thickness

AD Aqueous depth (Back of the cornea to front of

the lens)

ACD Anterior chamber depth

LT Lens thickness

AL 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

The values displayed (flat radius, steep radius)

correspond to the radii of an ellipsoid that fits into the

cornea. The axis of its rotation is measured counter-

clockwise from the horizontal to the flat radius.

• a: Flat radius

• b: Steep radius

• c: Axis of rotation

4.3.3 Topography, Elevation and Pachymetry

The 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 axis

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

diameter of an ideal circle.

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

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.

5 Commissioning

The device is powered though an integrated medical grade power supply, it works

with the voltages specified under chapter 6.2 'Power'. It is not necessary to select

the 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

seconds.

• 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 extended period of time.

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6 Technical data

6.1 General data

Type designation: Eyestar 900

Dimensions: 480 × 560 × 460 mm

Weight: 31.0 kg

6.2 Power

Input: 100 – 240 VAC, 50 – 60 Hz, 200 VA

6.3 Illumination modalities

6.3.1 OCT light source

Light source: Wavelength tunable laser

Wavelength range: 1030 nm … 1080 nm

Power on patient’s eye ≤ 2.0 mW

6.3.2 Imaging system light source

Light source: Infrared and warm white LEDs

Wavelength: 850 nm (IR)

warm white

6.3.3 Primary fixation target

Light source: LEDs

Wavelength: 525 nm (green)

624 nm (red)

6.3.4 Fellow eye fixation target

Light source: LEDs

Wavelength: 625 nm (red)

6.4 Measured variables

In-vivo repeatabilities reported in this chapter are based on N=46 eyes (one eye per

subject). 32 phakic (healthy and cataract) and 14 pseudophakic eyes were included.

In-vivo repeatability is calculated as the standard deviation of pairwise differences of

three repeated measurements per eye for all eyes. Aphakic and oil-filled eyes can

be measured 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 μm

Display resolution: 1 μm

In vivo repeatability (1. SD): ± 1.5 μm

6.4.2 Anterior chamber depth (ACD)

Measurement range: 1.8 - 6.3 mm

Display resolution: 0.01 mm

In vivo repeatability (1. SD): ± 0.014 mm

6.4.3 Lens thickness (LT)

Measurement range: 0.5 - 6.5 mm

Display resolution: 0.01 mm

In vivo repeatability (1. SD): ± 0.015 mm

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6.4.4 Axial length (AL)

Measurement range: 14 - 38 mm

Display resolution: 0.01 mm

In vivo repeatability (1. SD): ± 0.005 mm

6.4.5 Keratometry (K)

Measurement range K: 32.1 - 67.5 dpt

Display resolution K: 0.01 dpt

In vivo repeatability Kmean (1. SD): ± 0.067 dpt

In vivo repeatability AST (1. SD): ± 0.127 dpt

Measurement range Axis: 0 - 180°

Display resolution Axis: 1°

In vivo repeatability Axis, 0.5 dpt < AST ≤ 1.5 dpt (1. SD): ± 4.5°

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

6.4.6 White-to-white distance (WTW)

Measurement range: 7 - 16 mm

Display resolution: 0.01 mm

In vivo repeatability (1. SD): ± 0.079 mm

6.4.7 Pupillometry (PD)

Measurement range: 2 - 13 mm

Display resolution: 0.01 mm

6.5 Topography

In-vivo repeatabilies reported in this chapter are based on a clinical investigation

with N = 29 subjects, including 42 eyes with healthy cornea and 16 eyes with

irregular corneal shape, comprising the following pathologies/treatments:

Keratoconus, DSAEK, corneal crosslinking, Pseudoexfoliation Syndrome, corneal

transplant, susp. Salzmann degeneration, corneal lesion, corneal indentation. Only

one eye per subject per class (healthy cornea, irregular corneal shape) is included in

the analysis.

Covered area (diameter): Standard 7.5 mm / Extended 12 mm

6.5.1 Invivo repeatability standard topography (7.5 mm

diameter)

This repeatability table is based on N=32 eyes (including 9 eyes with irregular

corneal shape), with three measurements per eye.

Area

Center zone Middle zone Outer zone

Measurand Unit

Mean1) 2 Std.

Dev.2)

Mean 2 Std.

Dev.

Mean 2 Std.

Dev.

Anterior corneal curvature dpt 0.25 0.44 0.12 0.36 0.092 0.44

Posterior corneal

curvature

dpt 0.027 0.064 0.018 0.050 0.015 0.062

Anterior elevation μm – 2.9 – 3.9 – 5.1

Posterior elevation μm – 2.9 – 4.8 – 5.9

Pachymetry μm – 2.2 – 3.7 – 4.7

Areas indicate the center zone (diameter ≤ 3 mm), middle zone (3 mm < diameter ≤

6 mm) and outer zone (diameter > 6 mm) 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.

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6.5.2 Simulated Anterior Keratometry (SimK), standard

topography (7.5 mm diameter)

Reported in-vivo repeatabilities are based on N=32 eyes, including 9 eyes with

irregular corneal shape. In-vivo repeatability is calculated as the standard deviation

of pairwise differences of three repeated measurements per eye for all eyes.

Measurement range SimK: 32.1 - 67.5 dpt

Display resolution SimK: 0.01 dpt

In vivo repeatability SimKmean (1. SD): ± 0.22 dpt

In vivo repeatability SimAST (1. SD): ± 0.18 dpt

Measurement range SimAxis: 0 - 180°

Display resolution SimAxis: 1°

In vivo repeatability SimAxis, 0.5 dpt < AST ≤ 1.5 dpt (1. SD): ± 3.7°

In vivo repeatability SimAxis, AST > 1.5 dpt (1. SD): ± 2.1°

Display resolution Corneal Shape Factor: 0.01

In vivo repeatability Corneal Shape Factor: 0.07

6.5.3 Simulated Posterior Keratometry (SimPK), standard

topography (7.5 mm diameter)

Reported in-vivo repeatabilities are based on N=31 eyes, including 8 eyes with

irregular corneal shape. In-vivo repeatability is calculated as the standard deviation

of pairwise differences of three repeated measurements per eye for all eyes.

Measurement range SimPK: 3.9 - 9.5 dpt

Display resolution SimPK: 0.01 dpt

In vivo repeatability SimPKmean (1. SD): ± 0.032 dpt

In vivo repeatability SimPAST (1. SD): ± 0.029 dpt

Measurement range SimPAxis: 0 - 180°

Display resolution SimPAxis: 1°

In vivo repeatability SimPAxis, SimPAST > 0.5 dpt (1. SD): no occurrences

Display resolution Posterior Corneal Shape Factor: 0.01

In vivo repeatability Posterior Corneal Shape Factor: 0.09

6.5.4 Invivo repeatability extended topography (12 mm

diameter)

This repeatability table is based on N=31 eyes (including 8 eyes with irregular

corneal shape), with three measurements per eye.

Area

Center zone Middle zone Outer zone

Measurand Unit

Mean1) 2 Std.

Dev.2)

Mean 2 Std.

Dev.

Mean 2 Std.

Dev.

Anterior corneal curvature dpt 0.17 0.32 0.084 0.30 0.063 0.36

Posterior corneal

curvature

dpt 0.025 0.052 0.013 0.056 0.011 0.072

Anterior elevation μm – 2.8 – 4.6 – 6.5

Posterior elevation μm – 2.7 – 5.5 – 8.9

Pachymetry μm – 2.5 – 4.2 – 7.5

Areas indicate the center zone (diameter ≤ 3 mm), middle zone (3 mm < diameter ≤

6 mm) and outer zone (diameter > 6 mm) 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.

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6.5.5 Simulated Anterior Keratometry (SimEK), extended

topography (12 mm diameter)

Reported in-vivo repeatabilities are based on N=30 eyes, including 7 eyes with

irregular corneal shape. In-vivo repeatability is calculated as the standard deviation

of pairwise differences of three repeated measurements per eye for all eyes.

Measurement range SimEK: 32.1 - 67.5 dpt

Display resolution SimEK: 0.01 dpt

In vivo repeatability SimEKmean (1. SD): ± 0.14 dpt

In vivo repeatability SimEAST (1. SD): ± 0.095 dpt

Measurement range SimEAxis: 0 - 180°

Display resolution SimEAxis: 1°

In vivo repeatability SimEAxis, 0.5 dpt < AST ≤ 1.5 dpt (1.

SD):

± 2.6°

In vivo repeatability SimEAxis, AST > 1.5 dpt (1. SD): ± 2.4°

Display resolution Corneal Shape Factor: 0.01

In vivo repeatability Corneal Shape Factor: 0.05

6.5.6 Simulated Posterior Keratometry (SimEPK), extended

topography (12 mm diameter)

Reported in-vivo repeatabilities are based on N=29 eyes, including 6 eyes with

irregular corneal shape. In-vivo repeatability is calculated as the standard deviation

of pairwise differences of three repeated measurements per eye for all eyes.

Measurement range SimEPK: 3.9 - 9.5 dpt

Display resolution SimEPK: 0.01 dpt

In vivo repeatability SimEPKmean (1. SD): ± 0.019 dpt

In vivo repeatability SimEPAST (1. SD): ± 0.023 dpt

Measurement range SimEPAxis: 0 - 180°

Display resolution SimEPAxis: 1°

In vivo repeatability SimEPAxis, SimEPAST > 0.5 dpt (1. SD): no occurrences

Display resolution Posterior Corneal Shape Factor: 0.01

In vivo repeatability Posterior Corneal Shape Factor: 0.06

6.5.7 Normative considerations:

Eyestar 900 complies with the standard EN ISO 19980:2012 for corneal topography

systems, type A.

6.5.8 Cristalline lens tilt

Reported in-vivo repeatabilities are based on N=28 phakic eyes (one eye per

subject). In-vivo repeatability is calculated as the standard deviation of pairwise

differences of three repeated measurements per eye for all eyes.

Crystalline lens tilt

measurand

unit measured in-vivo

repeatability base on

standard topograhy (7.5

mm)

measured in-vivo

repeatability base on

extended topograhy (12

mm)

Lens tilt, axial angle ° 0.1 0.1

Lens tilt, rotational

angle

° 2.3 1.8

Lens decentration X,

Lens DX

μm 10.3 8.4

Lens decentration Y,

Lens DY

μm 8.7 7.1

7 Software / Help menu / Error messages

The software’s help section contains instructions and help for performing an

examination and descriptions of the error messages. The help can be opened via

the F1 key or in the [?] – [Help] menu.

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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 Maintenance

The 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.

8.1 Cleaning

The cleaning intervals for cleaning the complete device shall be performed within

reasonable time (e.g. once a week). Cleaning of applied parts shall be performed

prior 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 stand

The device patient interface cover glasses shall only be cleaned with the HS

Lenspen.

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

including 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

device is not in use.

WARNING!

The device must not be switched on when covered! (Heat build-up, fire

hazard).

9Appendix

9.1 Accessories / consumables / spare parts / upgrade

Components REF

Chin rest shell 1022709

Forehead rest band 1022903

Cable Power Inlet Adapter 1023026

Packaging 1023037

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Dust Protection Cover 1802304

HS Lenspen 1820415

9.2 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 chapter 'Observed standards'.

• This is a Class IIa 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 standards and directives.

• You can request a copy of the declaration of conformity for the device from

Haag-Streit at any time.

9.3 Classification

EN 60601-1:2006+A1:2013/AN Continuous operation

EN 60825-1:2014 Laser class I

EN 60529:1991+A1:2000 Enclosure protection IP20

EN 62471:2008 Exempt group

EN ISO 15004-2:2007 Group 2

ISO 19980:2012 Corneal topographer, type A

93/42/EEC (medical devices) Class IIa

9.4 Disposal

Electrical and electronic devices must be disposed of separately

from household waste! This device was made available for sale

after the 13th August 2005. For correct disposal, please contact

your Haag-Streit representative. This will guarantee that no

hazardous substances enter the environment and that valuable raw

materials are recycled.

9.5 Observed standards

EN 60601-1 EN 60529

EN 60601-1-2 EN ISO 15004-1

EN 62471 EN ISO 15004-2

EN 60825-1 EN ISO 19980

9.6 Information and manufacturer's declaration concerning

electromagnetic compatibility (EMC)

9.6.1 General

This device fulfills the requirements on electromagnetic compatibility according to

IEC 60601-1-2:2014 (4th Edition). The device is built so that the generation and

emission of electromagnetic interference is limited to the extent that other devices

are not disturbed in their use in accordance with the regulations and so that the

device itself is suitably immune to electromagnetic interference.

WARNING!

•Electrical medical devices and systems are subject to special EMC

measures and must be installed in accordance with the EMC

instructions contained in this accompanying document.

• Portable and mobile HF communication systems may interfere with

electrical medical devices.

• Use of accessories, transducers and cables other than those

specified or provided by Haag-Streit could result in increased

electromagnetic emissions or decreased electromagnetic immunity

of this device and result in improper operation.

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9.6.2 Emitted interference

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

environment.

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

Harmonics emissions

IEC 61000-3-2

Class A