Haag-Streit Eyestar 900 User manual

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220686‑04030 – 2023 – 01
INSTRUCTIONS FOR USE
Biometer
EYESTAR 900¨
3. Edition / 2023 – 01

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220686‑04030 – 2023 – 01
INSTRUCTIONS FOR USE
Biometer
EYESTAR 900¨
3. Edition / 2023 – 01
Preface
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 pa-
tient.
NOTE!
For USA only: Federal law restricts this device to sale by or on the order
of a physician or licensed practitioner.
Contents
¥ 1 Safety...................................................................................................................................................4
◦ 1.1 Comments on these instructions for use........................................................................................4
◦ 1.2 Ambient conditions.........................................................................................................................4
◦ 1.3 Shipment and unpacking ...............................................................................................................4
◦ 1.4 Installation warnings ......................................................................................................................4
◦ 1.5 Operation, environment .................................................................................................................5
◦ 1.6 Plausibility of the measurements ...................................................................................................6
◦ 1.7 IOL calculation ...............................................................................................................................7
◦ 1.8 Optical radiation.............................................................................................................................8
◦ 1.9 Disinfection ....................................................................................................................................8
◦ 1.10 Warranty and product liability ..................................................................................................... 8
◦ 1.11 Reporting obligation..................................................................................................................... 8
◦ 1.12 Description of symbols ................................................................................................................ 8
¥ 2 Intended purpose / intended use....................................................................................... 9
◦ 2.1 Device description ......................................................................................................................... 9
▪ 2.1.1 Intended users.................................................................................................................... 9
◦ 2.2 Medical purpose ............................................................................................................................9
▪ 2.2.1 Indications .......................................................................................................................... 9
▪ 2.2.2 Part of the body.................................................................................................................. 9
▪ 2.2.3 Patient population............................................................................................................... 9

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220686‑04030 – 2023 – 01
▪ 2.2.4 Contraindications................................................................................................................9
◦ 2.3 Principles of operation ...................................................................................................................9
▪ 2.3.1 Operating environment .....................................................................................................10
◦ 2.4 Clinical benefit..............................................................................................................................10
¥ 3 Introduction ...................................................................................................................................10
◦ 3.1 Eyestar 900 components .............................................................................................................10
◦ 3.2 Device state indicator...................................................................................................................11
◦ 3.3 Touch screen ...............................................................................................................................11
¥ 4 Device assembly / installation ...........................................................................................11
◦ 4.1 Mains switch and power socket ...................................................................................................11
◦ 4.2 Power button................................................................................................................................11
◦ 4.3 LAN socket...................................................................................................................................11
◦ 4.4 USB sockets ................................................................................................................................11
◦ 4.5 Display port socket.......................................................................................................................11
◦ 4.6 Forehead band and chin rest.......................................................................................................11
◦ 4.7 Replacement of the forehead band..............................................................................................12
◦ 4.8 Replacement of the chin rest tray ................................................................................................12
¥ 5 Operation.........................................................................................................................................12
◦ 5.1 Position of patient during measurement ......................................................................................12
◦ 5.2 Fixation ........................................................................................................................................13
◦ 5.3 Measured variables......................................................................................................................13
▪ 5.3.1 A-Scan..............................................................................................................................13
▪ 5.3.2 Keratometry ......................................................................................................................13
▪ 5.3.3 Topography, Elevation and Pachymetry...........................................................................13
▪ 5.3.4 White to white distance, pupillometry and eccentricity of the visual axis..........................13
¥ 6 Commissioning ...........................................................................................................................14
◦ 6.1 Switching on the device ...............................................................................................................14
◦ 6.2 Switching off the device ...............................................................................................................14
¥ 7 Technical data..............................................................................................................................14
◦ 7.1 General data ................................................................................................................................14
◦ 7.2 Power...........................................................................................................................................14
◦ 7.3 Illumination modalities..................................................................................................................14
▪ 7.3.1 OCT light source...............................................................................................................14
▪ 7.3.2 Imaging system light source .............................................................................................14
▪ 7.3.3 Primary fixation target.......................................................................................................14
▪ 7.3.4 Fellow eye fixation target..................................................................................................14
◦ 7.4 Measured variables......................................................................................................................14
▪ 7.4.1 Central Corneal Thickness (CCT).....................................................................................14
▪ 7.4.2 Anterior chamber depth (ACD) .........................................................................................14
▪ 7.4.3 Lens thickness (LT) ..........................................................................................................15
▪ 7.4.4 Axial length (AL) ...............................................................................................................15
▪ 7.4.5 Keratometry (K) ................................................................................................................15
▪ 7.4.6 White-to-white distance (WTW)........................................................................................15
▪ 7.4.7 Pupillometry (PD)..............................................................................................................15
◦ 7.5 Topography..................................................................................................................................15
▪ 7.5.1 In vivo repeatability standard topography (7.5 mm diameter)...........................................15
▪ 7.5.2 Simulated Anterior Keratometry (SimK), standard topography (7.5 mm diameter) ..........16
▪ 7.5.3 Simulated Posterior Keratometry (SimPK), standard topography (7.5 mm diameter)...... 16
▪ 7.5.4 In vivo repeatability extended topography (12 mm diameter) ..........................................16
▪ 7.5.5 Simulated Anterior Keratometry (SimEK), extended topography (12 mm diameter)........ 16
▪ 7.5.6 Simulated Posterior Keratometry (SimEPK), extended topography (12 mm diameter) ...17
▪ 7.5.7 Normative considerations:................................................................................................ 17
▪ 7.5.8 Crystalline lens tilt ............................................................................................................17
¥ 8 Software / Help menu / Error messages...................................................................... 18
¥ 9 Maintenance.................................................................................................................................. 18
◦ 9.1 Cleaning and disinfection ............................................................................................................18
▪ 9.1.1 Device in general.............................................................................................................. 18
▪ 9.1.2 Applied parts ....................................................................................................................18
▪ 9.1.3 Tools................................................................................................................................. 18
▪ 9.1.4 Cleaning and disinfecting details...................................................................................... 19
◦ 9.2 Dust cover ................................................................................................................................... 19
¥ 10 Appendix ...................................................................................................................................... 19
◦ 10.1 Accessories / consumables / spare parts / upgrade.................................................................. 19
◦ 10.2 Legal regulations .......................................................................................................................19
◦ 10.3 Classification ............................................................................................................................. 19
◦ 10.4 Disposal..................................................................................................................................... 20
◦ 10.5 Observed standards ..................................................................................................................20
◦ 10.6 Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) .20
▪ 10.6.1 General........................................................................................................................... 20
▪ 10.6.2 Emitted interference .......................................................................................................21
▪ 10.6.3 Electromagnetic immunity environment tested (part 1).................................................. 22
▪ 10.6.4 Electromagnetic immunity environment tested (part 2).................................................. 23
▪ 10.6.5 Recommended separation distances between portable and mobile RF communications
equipment and this product....................................................................................................... 25

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220686‑04030 – 2023 – 01
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 op-
eration of the product and to avoid any danger to users and to patients.
NOTE!
Important information, please read carefully.
1.1 Comments on these instructions for use
NOTE!
In these instructions for use the point is used as decimal separator.
1.2 Ambient conditions
Transport Temperature −40 °C ... +70 °C
Air pressure 500 hPa ... 1060 hPa
Relative humidity 10 % ... 95 %
Storage Temperature −10 °C ... +55 °C
Air pressure 700 hPa ... 1060 hPa
Relative humidity 10 % ... 95 %
Use Temperature +10 °C ... +35 °C
Air pressure 800 hPa ... 1060 hPa
Relative humidity 30 % ... 90 %
1.3 Shipment and unpacking
• Before unpacking the device, check whether the packaging shows traces of im-
proper handling or damage. If this is the case, notify the transport company that
delivered the goods to you.
• Unpack the device 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 (condens-
ation).
• 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 potential 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.
1.4 Installation warnings
WARNING!
• Grounding reliability can only be achieved when unit is connected to
a hospital grade receptacle. (Not valid for EU countries).
• The plug, cable and socket must function perfectly. The electrical
connection must feature safety earth.
• Before carrying out maintenance or cleaning and disinfection work,
the device must always be disconnected from the mains by unplug-
ging 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 isola-

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220686‑04030 – 2023 – 01
tion to external networks (isolating transformer, galvanic Ethernet
isolator, etc.).
• The device must be positioned in such a way that proper heat dis-
persion / 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.
1.5 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
volatile solvents (alcohol, petrol, etc.) and flammable anaesthetics
are in use.
WARNING!
• The doctor or the operator is obliged to inform the patient about the
safety instructions concerning him and to ensure that these instruc-
tions are complied with.
• Only staff trained and experienced in the assessment of measuring
data and calculations and the manual entry, editing and deletion of
data may examine patients, operate the device and interpret results.
• All users must be appropriately trained and familiarised with the con-
tents 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 only influences measurement of the pupil dia-
meter (pupillometry).
•Do not place any unapproved optical elements between the device
and the patient’s eye.
• This device must not be operated near of high frequency surgical
equipment and the radio frequency shielded room of a medical elec-
trical system for magnetic resonance imaging, where the intensity of
electromagnetic disturbances is high.
• Portable radio frequency communications equipment (including peri-
pherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the device, in-
cluding cables specified by Haag-Streit. Otherwise, degradation of
the performance of this device could result.
NOTE!
• This device may only be used in accordance with the instructions in
the 'Intended purpose / intended use' chapter.
• Installation only by trained specialists.
• If EyeSuite is used on an external PC for the review and further ana-
lysis 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 out-
side the specified ambient conditions (see chapter 'Ambient condi-
tions').
• The device is to be used in a room in the medical area with attenu-
ated light.
• If the device is moved/transported, a functional check must be per-
formed in accordance with the software instructions for use.
• If the device or accessories to it are exposed to the effects of an ex-
ternal 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 meas-
urement.