Haag-Streit Eyestar 900 Instructions For Use Manual
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Haag-Streit Eyestar 900 Instructions For Use Manual

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04010 – 1. Edition / 2020 – 05
1500_7220686_04010_ Gebrauchsanweisung_ES-900_01_eng.indd 1
1500_7220686_04010_ Gebrauchsanweisung_ES-900_01_eng.indd 1
SVENSKA
NEDERLANDS
PORTUGUÊS
ESPAÑOL
ITALIANO
FRANÇAIS
INSTRUCTIONS FOR USE
Biometer
Eyestar 900
1. Edition / 2020 – 05
DEUTSCH
ENGLISH
®
1
26.03.2020 14:22:40
26.03.2020 14:22:40

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  • Page 1 ITALIANO FRANÇAIS DEUTSCH ENGLISH INSTRUCTIONS FOR USE Biometer Eyestar 900 ® 1. Edition / 2020 – 05 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04010 – 1. Edition / 2020 – 05 1500_7220686_04010_ Gebrauchsanweisung_ES-900_01_eng.indd 1 1500_7220686_04010_ Gebrauchsanweisung_ES-900_01_eng.indd 1 26.03.2020 14:22:40...
  • Page 2 NOTE! Federal law restricts this device to sale by or on the order of a physician or licensed practitioner. Intended use The Eyestar 900 is a non-invasive, non-contact biometer used for obtaining fol- lowing information: • Corneal shapes •...

  • Page 3: Table Of Contents

    6.4.6 Simulated Anterior Keratometry (SimK) ..............12 Basic construction .....................8 6.4.7 Simulated Posterior Keratometry (SimPK) ..............13 Operating principles ....................8 6.4.8 White-to-white distance (WTW) ................13 Eyestar 900 components ..................8 6.4.9 Pupillometry (PD) ....................13 Device state indicator ....................9 Topography ......................13 Touch screen ......................9 Software / Help menu / Error messages ......

  • Page 4: Safety

    RF telephone in • If packed in its original packing, then the device may comply with the transport condi- the immediate vicinity to the Eyestar 900. Increase the distance to the unit tions according to ISO 15004-1. until the interference disappears.

  • Page 5: Operation, Environment

    SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH • • Before carrying out maintenance or cleaning work, the device must al- If EyeSuite is used on an external PC for the review and further analysis ways be disconnected from the mains by unplugging the power supply of the data acquired with the device, then the PC on which the EyeSuite or plug.

  • Page 6: Plausibility Of The Measurements

    ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA • • Extensive amounts of ametropia of the patient may be corrected using Keratometry may be erroneous in eyes that have undergone keratore- glasses or trial lenses during the measurement. Contact lenses may not fractive surgery because such eyes may significantly deviate from spher- be used for this purpose as they would lead to inaccurate measurement ical surfaces.

  • Page 7: Iol Calculation

    (IOL). A further important parameter in cal- cribed in the documents distributed with the product. culating the lens to be implanted is the IOL constant. When using the Eyestar 900, • The product must be treated as described in the ‘Safety’ chapter. Improper hand- only IOL constants optimised for optical biometers should be used.

  • Page 8: Introduction

    Introduction 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. Eye- Suite is the software that runs the unit and is pre-installed on the built in computer.

  • Page 9: Device State Indicator

    Pulsing orange Standby 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 Green On no measurement in process...

  • Page 10: Replacement Of The Chin Rest Tray

    ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA slide mechanism. After the left side is loose, pull on the left edge to unclick it from The patient should sit upright, in a relaxed position. Adjust the height of the instru- its mount on the device.

  • Page 11: Measured Variables

    SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH Measured variables 4.3.4 White to white distance, pupillometry and eccentricity 4.3.1 A-Scan of the visual axis Depending on the patient’s gaze at the fixation light, the optical path length of the vi- The white-to-white distance (WTW) is determined using the image of the iris and sual axis is measured: the eye radii obtained from keratometry.

  • Page 12: Power

    ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA Power 6.4.2 Anterior chamber depth (ACD) Input: 100 – 240 VAC, 50 – 60 Hz, 200 VA Measurement range: 1.8 - 6.3 mm Display resolution: 0.01 mm Illumination modalities In vivo repeatability (1. SD): ± 0.014 mm 6.3.1 OCT light source 6.4.3 Lens thickness (LT) Light source: Wavelength tunable laser...

  • Page 13: Simulated Posterior Keratometry (Simpk)

    Display resolution Posterior Corneal Shape 0.01 Normative considerations: Factor: Eyestar 900 complies with the standard EN ISO 19980:2012 for corneal topography In vivo repeatability Posterior Corneal Shape 0.11 systems, type A. Factor: Software / Help menu / Error messages 6.4.8 White-to-white distance (WTW)

  • Page 14: Cleaning

    • Device cover (casing) • • Haag-Streit maintains a quality management system in accordance with EN ISO User interface display panel 13485. The device has been developed and designed taking into consideration all the • User interface display panel surroundings and stand standards listed in section E ‘Standards’.

  • Page 15: Disposal

    Electrical and electronic devices must be disposed of separately from household waste! This appliance was made available for sale after the 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.

  • Page 16: Emc Supplement

    The use of cables or equipment other than those listed may lead to a terference. higher emission or to reduced interference immunity of the Eyestar 900 bi- ometer system. Emitted interference (standard table 1)

  • Page 17: Immunity (Standard Table 2)

    SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH Immunity (standard table 2) The information is based on the requirements of EN 60601-1-2:2007 (IEC 3 edition). Guidance and manufacturer's declaration – electromagnetic immunity This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi- ronment.

  • Page 18: Immunity On Non-Life Support Devices (Standard Table 4)

    ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA Immunity on non-life support devices (standard table 4) The information is based on the requirements of EN 60601-1-2:2007 (IEC 3 edition). Guidance and manufacturer's declaration – electromagnetic immunity This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi- ronment.

  • Page 19: Safe Distances On Non-Life Support Devices (Standard Table 6)

    SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH Safe distances on non-life support devices (standard table 6) The information is based on the requirements of EN 60601-1-2:2007 (IEC 3 edition). Recommended safe distances between portable and mobile HF communication devices and this device. This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled.
  • Page 20 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA Should you have any further questions, please contact your Haag-Streit representative at: http://www.haag-streit.com/contact/contact-your-distributor.html HAAG-STREIT AG Gartenstadtstrasse 10 0297 3098 Koeniz, Switzerland Phone +41 31 978 01 11 +41 31 978 02 82 eMail info@haag-streit.com...

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