Haag-Streit Eyestar 900, Инструкция по эксплуатации

Страница: 8 / 25

8
DEUTSCH ENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
• The measured results of patients with asteroid hyalosis may not be
accurate (in particular the axial length measurement) and must
therefore be verified by the user in terms of their plausibility.
1.8 IOL calculation
The measurements taken with the Eyestar 900 may serve as the central element for
the calculation of intraocular lenses (IOL). A further important parameter in
calculating the lens to be implanted is the IOL constant. When using the Eyestar
900, only IOL constants optimised for optical biometers should be used. Please
contact your IOL manufacturer for information on optimised IOL constants for optical
biometry. An alternative source of information for IOL constants optimised for optical
biometry is the website of the 'User Group for Laser Interference Biometry' (ULIB)
( http://ocusoft.de/ulib/c1.htm ). Downloadable IOL Constants files for the Eyestar
900, featuring the ULIB IOL-Constants for the formulas implemented in EyeSuite
IOL are available in the Key-User section of the Haag-Streit homepage.
To further improve the clinical result, Haag-Streit recommends that every surgeon
creates personally optimised IOL constants based on pre-operative measurement
data generated with the Eyestar 900 and reliable postoperative data (e.g., 3 months
after the operation).
1.9 Optical radiation
WARNING!
The light of this device may de dangerous. The risk of eye damage
increases with the number of examinations in succession per eye. An
examination time with this device of over 225 individual examinations
exceeds the risk guideline value.
NOTE!
• This device complies with the light exposure limits for class 2
ophthalmic devices according to EN ISO 15004-2:2007.
• This device is a class 1 laser device in accordance with IEC
60825-1.
• The device complies with the exempt (risk free) group in accordance
with IEC 62471.
1.10 Disinfection
NOTE!
• The device does not need to be disinfected.
• The device complies with the exempt (risk free) group in accordance
with IEC 62471:2006
For more information on cleaning, please refer to the ‘Maintenance’ chapter.
1.11 Warranty and product liability
• Haag-Streit products must be used only for the purposes and in the manner
described in the documents distributed with the product.
• The product must be treated as described in the ‘Safety’ chapter. Improper
handling can damage the product. This would void all guarantee claims.
• Continued use of a product damaged by incorrect handling may lead to personal
injury. In such a case, the manufacturer will not accept any liability.
• Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
• Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
• This product is covered by a limited warranty granted by your seller.
For USA only:
• This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
1.12 Description of symbols
Follow instruction for use
Read the instructions for use
attentively
General warning: Read the
accompanying documentation
European certificate of
conformity
Date of manufacture Manufacturer