Haag-Streit EYESTAR 900 Instructions For Use Manual
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Summary of Contents for Haag-Streit EYESTAR 900
- Page 1 SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS INSTRUCTIONS FOR USE Biometer EYESTAR 900 ¨ 2. Edition / 2021 – 05 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05...
- Page 2 SVENSKA PORTUGUÊS INSTRUCTIONS FOR USE Introduction 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.
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Page 3: Table Of Contents
◦ 2.2 Operating principles ........................9 ▪ 6.5.3 Simulated Posterior Keratometry (SimPK), standard topography (7.5 mm diameter)..16 ◦ 2.3 Eyestar 900 components .......................9 ▪ 6.5.4 Invivo repeatability extended topography (12 mm diameter) ........... 16 ◦ 2.4 Device state indicator........................10 ▪... -
Page 4: Safety
1.1 Areas of application of the device Air pressure 500 hPa ... 1060 hPa The Eyestar 900 is an optical non contact Biometer providing measurements and Relative humidity 10 % ... 95 % imaging of the eye from the cornea to the retina based on Swept Source OCT, reflective Keratometry and Video image analysis technology. - Page 5 Haag-Streit representative. 1.6 Operation, environment • Store packaging material carefully, so that it can be used for possible returns or when moving.
- Page 6 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS • If EyeSuite is used on an external PC for the review and further • Housing parts of the device may only be removed by suitably trained analysis of the data acquired with the device, then the PC on which and authorised specialist personnel.
- Page 7 SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS • If the patient has previously undergone cataract surgery, available • The user must check the A and B-Scan when measuring anterior records should be consulted for plausibility check of the chamber depth in pseudophakic mode. If only one IOL signal is measurement.
- Page 8 1.8 IOL calculation with IEC 62471:2006 The measurements taken with the Eyestar 900 may serve as the central element for For more information on cleaning, please refer to the ‘Maintenance’ chapter. the calculation of intraocular lenses (IOL). A further important parameter in calculating the lens to be implanted is the IOL constant.
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Page 9: Introduction
8. Device state indicator 18. Connector panel cover 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. -
Page 10: Device Assembly / Installation
• 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... -
Page 11: Power Button
3.1 Mains switch and power socket 3.6 Headband and chin rest The mains connector of the Eyestar 900 is a C 13 Socket. It is located under the For cleaning and periodical exchange, the headband as well as the chin rest may be device and allows invisible cable management if the device is used on a table removed from the device. -
Page 12: Replacement Of The Chin Rest Tray
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 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. -
Page 13: Commissioning
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 4.3.4 White to white distance, pupillometry and eccentricity of CCT Central corneal thickness the visual axis Aqueous depth (Back of the cornea to front of the lens) The white-to-white distance (WTW) is determined using the image of the iris and the eye radii obtained from keratometry. -
Page 14: Illumination Modalities
Light source: LEDs 6.1 General data Wavelength: 625 nm (red) Type designation: Eyestar 900 6.4 Measured variables Dimensions: 480 × 560 × 460 mm In-vivo repeatabilities reported in this chapter are based on N=46 eyes (one eye per Weight: 31.0 kg subject). -
Page 15: Axial Length (Al)
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 6.4.4 Axial length (AL) irregular corneal shape, comprising the following pathologies/treatments: Keratoconus, DSAEK, corneal crosslinking, Pseudoexfoliation Syndrome, corneal Measurement range: 14 - 38 mm transplant, susp. Salzmann degeneration, corneal lesion, corneal indentation. Only one eye per subject per class (healthy cornea, irregular corneal shape) is included in Display resolution: 0.01 mm... -
Page 16: Simulated Anterior Keratometry (Simk), Standard Topography (7.5 Mm Diameter)
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 6.5.2 Simulated Anterior Keratometry (SimK), standard Display resolution SimPAxis: 1° topography (7.5 mm diameter) In vivo repeatability SimPAxis, SimPAST > 0.5 dpt (1. SD): no occurrences Reported in-vivo repeatabilities are based on N=32 eyes, including 9 eyes with Display resolution Posterior Corneal Shape Factor: 0.01 irregular corneal shape. -
Page 17: Simulated Anterior Keratometry (Simek), Extended Topography (12 Mm Diameter)
Measurement range SimEK: 32.1 - 67.5 dpt 6.5.7 Normative considerations: Display resolution SimEK: 0.01 dpt Eyestar 900 complies with the standard EN ISO 19980:2012 for corneal topography systems, type A. In vivo repeatability SimEK (1. SD): ± 0.14 dpt mean 6.5.8 Cristalline lens tilt... -
Page 18: Maintenance
8 Maintenance • Clean the complete device cover with the cover towel The Eyestar 900 is practically maintenance-free and requires only minimum care to • Put cleaning liquid evenly spread on the cover towel • Clean the display panel surroundings and stand with the cover towel work for as long as possible to your complete satisfaction. -
Page 19: Legal Regulations
EN ISO 15004-1 9.2 Legal regulations EN 62471 EN ISO 15004-2 • Haag-Streit maintains a quality management system in accordance with EN ISO 13485. The device has been developed and designed taking into consideration EN 60825-1 EN ISO 19980 all the standards listed in chapter 'Observed standards'. -
Page 20: Emitted Interference
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 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. -
Page 21: Electromagnetic Immunity Environment Tested (Part 1)
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 9.6.3 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 environment. -
Page 22: Electromagnetic Immunity Environment Tested (Part 2)
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 9.6.4 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 calculated from the equation applicable to the frequency of the transmitter. These guidelines may not apply in all situations. - Page 23 SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 28 V/m 28 V/m CDMA 850: max 2 W 1700 – 1990 MHz 1700 – 1990 MHz LTE Band 5: max 2 W 50% PM 217 Hz 50% PM 217 Hz GSM 1800/1900: max 2 W CDMA 1900: max 2 W 28 V/m 28 V/m...
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Page 24: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And This Product
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 9.6.5 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 prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recommended below, according to the maximum output power of the communication equipment. - Page 25 NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS Should you have any further questions, please contact your Haag-Streit representative at: Wiki Revision ID: 266202 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05...
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