Haag-Streit EYESTAR 900 Instructions For Use Manual
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- Page 1 SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS INSTRUCTIONS FOR USE Biometer EYESTAR 900 ¨ 3. Edition / 2023 – 01 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220686‑04030 – 2023 – 01...
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Page 2: Table Of Contents
SVENSKA PORTUGUÊS INSTRUCTIONS FOR USE Preface Biometer 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 EYESTAR 900 ¨ use of our product. WARNING! Read the instruction manual carefully before commissioning this product. - Page 3 7.5.7 Normative considerations:....................17 ¥ 3 Introduction ...........................10 ▪ 7.5.8 Crystalline lens tilt ......................17 ◦ 3.1 Eyestar 900 components ......................10 ¥ 8 Software / Help menu / Error messages ..............18 ◦ 3.2 Device state indicator........................11 ◦ 3.3 Touch screen ..........................11 ¥...
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Page 4: Comments On These Instructions For Use
Important information, please read carefully. 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 1.1 Comments on these instructions for use when moving. -
Page 5: Operation, Environment
30 cm (12 inches) to any part of the device, in- the mains. cluding cables specified by Haag-Streit. Otherwise, degradation of • Use of this device adjacent to or stacked with other equipment the performance of this device could result. -
Page 6: Plausibility Of The Measurements
SVENSKA PORTUGUÊS • Keep these instructions for use in a place where they are accessible Eyestar 900. Increase the distance to the device until the interfer- at all times to those working with the device. Warranty claims can ence disappears. -
Page 7: Iol Calculation
(IOL). A further important parameter in calculat- the IOL. Uncertainty in this case can lead to the displayed reading ing the lens to be implanted is the IOL constant. When using the Eyestar 900, only for anterior chamber depth being inaccurate by the thickness of the IOL constants optimised for optical biometers should be used. -
Page 8: Optical Radiation
Medical Device 1.10 Warranty and product liability Representative • Haag-Streit products must be used only for the purposes and in the manner de- Testsymbol of TÜV Rheinland MET Listed Mark with approval scribed in the documents distributed with the product. -
Page 9: Intended Purpose / Intended Use
2.1 Device description This device is intended for the examination of the human eye. The Eyestar 900 is a non-contact device for measuring the human eye, consisting of a swept-source OCT sub-unit (OCT: Optical Coherence Tomography, a measure- 2.2.3 Patient population ment method to acquire tomographic images by optical interferometry) and an ima- ging system sub-unit. -
Page 10: Introduction
3 Introduction 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 and some buttons at the device housing. EyeSuite is the software that runs the unit and is pre-installed on the built in computer. -
Page 11: Device State Indicator
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 The touch screen is mounted in the right side from the patient’s point of view as a an external EyeSuite database enabling the assessment of measurements on PC default location. -
Page 12: Replacement Of The Forehead Band
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 5 Operation 4.7 Replacement of the forehead band The forehead band is held in place with a click / slide mechanism. To remove it, 5.1 Position of patient during measurement push in the middle of the forehead band and pull on the left edge of the forehead band to loosen the slide mechanism. - Page 13 SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 5.3.2 Keratometry NOTE! In order to get the best possible results, the patient should be requested The values displayed (flat radius, steep radius) corres- to keep the eye as wide open as possible during the measurement and pond to the radii of an ellipsoid that fits into the cornea.
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Page 14: Commissioning
32 phakic (healthy and cataract) and 14 pseudophakic eyes were included. In-vivo re- Type designation: Eyestar 900 peatability 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 Dimensions: 480 ×... -
Page 15: Lens Thickness (Lt)
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 7.4.7 Pupillometry (PD) Display resolution: 0.01 mm In vivo repeatability (1 σ): ± 0.014 mm Measurement range: 2 - 13 mm Display resolution: 0.01 mm 7.4.3 Lens thickness (LT) 1 σ = One standard deviation Measurement range: 0.5 - 6.5 mm 7.5 Topography... -
Page 16: Simulated Posterior Keratometry (Simpk), Standard Topography (7.5 Mm Diameter)
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 7.5.2 Simulated Anterior Keratometry (SimK), standard topo- Display resolution Posterior Corneal Shape Factor: 0.01 graphy (7.5 mm diameter) In vivo repeatability Posterior Corneal Shape Factor (1 σ): 0.11 Reported in-vivo repeatabilities are based on N=32 eyes, including 9 eyes with irregular 1 σ... -
Page 17: Simulated Posterior Keratometry (Simepk), Extended Topography (12 Mm Diameter)
0.06 1 σ = One standard deviation 7.5.7 Normative considerations: Eyestar 900 complies with the standard EN ISO 19980:2012 for corneal topography sys- tems, type A. © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220686‑04030 – 2023 – 01... -
Page 18: Software / Help Menu / Error Messages
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 Patient interface consisting of the following applied parts: instructing a service engineer to inspect the biometer periodically. -
Page 19: Cleaning And Disinfecting Details
Packaging 1023037 The user interface touch screen shall be cleaned with the display towel Dust Protection Cover 1802304 The device patient interface cover glasses shall only be cleaned with the Haag-Streit Lenspen. Haag-Streit Lenspen 1820415 We suggest following cleaning/disinfecting procedure: 10.2 Legal regulations... -
Page 20: Disposal
• Use of accessories, transducers and cables other than those spe- EN 60825-1 EN ISO 19980 cified or provided by Haag-Streit could result in increased electro- magnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. -
Page 21: Emitted Interference
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 10.6.2 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 envir- onment. -
Page 22: Electromagnetic Immunity Environment Tested (Part 1)
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 10.6.3 Electromagnetic immunity environment tested (part 1) 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 envir- onment. -
Page 23: Electromagnetic Immunity Environment Tested (Part 2)
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 10.6.4 Electromagnetic immunity environment tested (part 2) Portable and mobile RF communications equipment should be used no closer to any part of this product, including cables, than the recommended separation distance calcu- lated from the equation applicable to the frequency of the transmitter. - Page 24 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 28 V/m 28 V/m GSM 1800/1900: max 2 W 2400 – 2570 MHz CDMA 1900: max 2 W 2400 – 2570 MHz 50% PM 217 Hz 50% PM 217 Hz DECT: max 2 W LTE Band 1, 3, 4, 25: max 2 W 9 V/m 9 V/m...
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Page 25: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And This Product
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 10.6.5 Recommended separation distances between portable and mobile RF communications equipment and this product This product is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help pre- vent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recom- mended below, according to the maximum output power of the communication equipment. - Page 26 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS Should you have any further questions, please contact your Haag-Streit representative at: www.haag-streit.com/haag-streit-group/contact/haag-streit-distributors/distributors HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland Phone +41 31 978 01 11 +41 31 978 02 82 eMail info@haag-streit.com...