Haag-Streit Lenstar LS 900 Instructions For Use Manual
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- Page 1 SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS INSTRUCTIONS FOR USE Biometer ¨ Lenstar LS 900 15. Edition / 2022 – 09 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220055‑04150 – 2022 – 09...
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Page 2: Table Of Contents
SVENSKA PORTUGUÊS Preface INSTRUCTIONS FOR USE Biometer Thank you for choosing a Haag-Streit device. Provided you comply carefully with the ¨ Lenstar LS 900 regulations in these instructions for use, we can guarantee reliable and trouble-free use of our product. - Page 3 7.3.2 Keratometry ........................17 ▪ 7.3.3 Illumination........................17 ▪ 7.3.4 Positioning aid (from serial number 2000) ................17 ◦ 7.4 Measured variables Lenstar LS 900 ....................17 ▪ 7.4.1 Central corneal thickness (CCT)..................17 ▪ 7.4.2 Anterior chamber depth (ACD) ..................17 ▪ 7.4.3 Lens thickness (LT) ......................17 ▪...
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Page 4: Safety
1.4 Installation warnings NOTE! In these instructions for use the point is used as decimal separator. WARNING! • Only use a Haag-Streit approved external medical power supply (EN 60601-1). 1.2 Ambient conditions • The plug, cable and socket must function perfectly. - Page 5 ENGLISH PORTUGUÊS such use is necessary, this device and the other equipment should cluding cables specified by Haag-Streit. Otherwise, degradation of be observed to verify that they are operating normally. the performance of this device could result. 1.5 Operation, environment NOTE! •...
- Page 6 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS wise, make sure that the device is switched off before attaching the • Prior to the measurement, the user must verify that the patient is not dust cover. wearing contact lenses. Wearing contact lenses will result in erro- neous measuring results.
- Page 7 A further important parameter in calculating the lens to be implanted is the constants. IOL constant. When using the Lenstar LS 900, only IOL constants optimised for op- © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220055‑04150 – 2022 – 09...
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Page 8: Optical Radiation
1.11 Warranty and product liability 1.8.2 IOL constants derived from data from a contact ultra- • Haag-Streit products must be used only for the purposes and in the manner de- sound biometer scribed in the documents distributed with the product. -
Page 9: Intended Purpose / Intended Use
2.1 Device description Testsymbol of TÜV Rheinland MET Listed Mark with approval The Lenstar LS 900 is a non-contact device for measurement of biometrical para- with approval for INMETRO for USA and Canada meters of the eye, aimed to assist the calculation of intraocular lenses (IOLs) before Brasil intraocular lens implantation. -
Page 10: Intended Users
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 2.1.1 Intended users 2.3.1 Operating environment Users are qualified medical professionals such as ophthalmologists, optometrists, This device is intended to be used in professional health care facilities such as hos- opticians, nurses and researchers or other qualified specialists as permitted by local pitals, physician's, optometrist's and optician's practices. -
Page 11: Introduction
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 3 Introduction T-Cone (option) 14. Dust cover for storage packaging 3.1 Basic construction 15. T-Cone topography add-on The system is divided into two parts: one concerned with examination (LS 900) and 16. 'Top' – shows which side of the T-Cone is up the other with control (Notebook, PC). -
Page 12: Control Component (Pc)
For further information, please con- NOTE! tact your Haag-Streit representative. • If the Lenstar LS 900 biometer with the optional T-Cone topography add-on is used on an instrument table with a Haag-Streit headrest, 3.4 Instrument table (option) the short forehead band delivered with the optional T-Cone must be used on the headrest for better measurability. -
Page 13: Operation
The T-Cone is held in place on the front ring of the fluence adjustment time and measuring accuracy. The Lenstar LS 900 biometer by strong magnets. patient should sit up as straight as possible. • Ensure that the red safety mark is no longer vis- ible on the locking clip. - Page 14 NOTE! • Place the T-Cone on the base plate of the storage • When you use the T-Cone for the first time with the Lenstar LS 900 packaging (19). biometer, the software will prompt you to calibrate the T-Cone with •...
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Page 15: A-Scan
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 5.5 Measured variables The values displayed (flat radius, steep radius) corres- pond to the radii of an ellipsoid that fits into the array 5.5.1 A-Scan of points. The axis of its rotation is measured counter- clockwise from the horizontal to the flat radius (35). -
Page 16: Commissioning
SVENSKA PORTUGUÊS 6 Commissioning 7 Technical data Power for the Lenstar LS 900 is supplied by a medical grade power supply which is Type designation: LS 900 provided with the device. Only use the power supply provided with the device. -
Page 17: Illumination Modalities
1° Wavelength: 940 nm In vivo repeatability (1 σ): ±11° 7.4 Measured variables Lenstar LS 900 7.4.6 White-to-white distance (WTW) Measurement ranges are based on the ‘Phakic’ measurement mode. Measurement range: 7 – 16 mm 7.4.1 Central corneal thickness (CCT) Display resolution: 0.01 mm... -
Page 18: Pupillometry
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 7.4.7 Pupillometry LT [mm] 27 / 54 4.56 0.08 0.01784 R [mm] 34 / 68 7.67 0.03 0.00396 Measurement range: 2 – 13 mm Display resolution: 0.01 mm Axis [°] 27 / 54 0.14191 The above mentioned measurement ranges correspond to the default setting for the automatic ana- WTW [mm]... -
Page 19: Technical Data Of T-Cone (Option)
SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 7.5 Technical data of T-Cone (option) Sphere 3 −0.017 0.056 0.46 −0.024 0.038 1.61 (mm) Type designation: T-Cone R=8.844 Sphere 4 −0.040 0.082 0.48 −0.069 0.044 0.58 Weight: 0.2 kg (mm) Diameter: ø... -
Page 20: Applied Parts
• The T-Cone must never be immersed in cleaning fluid or disinfect- for as long as possible to your complete satisfaction. However, we recommend in- ant. structing a service engineer to inspect the biometer periodically. Haag-Streit or your local agent will be happy to provide further information. 9.2.1 Device in general 9.1 Function check / nullification... -
Page 21: Appendix
PORTUGUÊS 10 Appendix 10.2 Legal regulations • Haag-Streit maintains a quality management system in accordance with EN ISO 10.1 Accessories / consumables / spare parts / upgrade 13485. The device was developed and designed in accordance with all the standards listed in chapter 'Observed standards'. -
Page 22: Disposal
• Use of accessories, transducers and cables other than those spe- cified or provided by Haag-Streit could result in increased electro- © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220055‑04150 – 2022 – 09... -
Page 23: 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 24: 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 25: 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 26 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 27: Recommended Separation Distances Between Portable And Mobile Rf Communications
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 28 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...
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