21
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220055‑04150 – 2022 – 09
10 Appendix
10.1 Accessories / consumables / spare parts / upgrade
Components
REF
Dust cover, small
1001395
Phillips screws for forehead band (4 pcs)
1005072
1023406
Checking gauge (replacement)
1021124
Short forehead band
1021653
Dust cover for storage packaging of T cone
1021665
Base plate for storage packaging of T-Cone
1021666
Eye patch
1400113
Base Plate small with Pivot
7200162
Base Plate small for headrest 7220477
7200163
T-Cone (without Toric Planner) only for use with the Eyesuite IOL Toric
Planner installed
7220384
EyeSuite IOL Toric Planner
7220396
T-Cone Toric Platform
7220397
Headrest (LS 900)
7220477
Set of table fittings LS 900 APS
7220750
Pad of chin rest papers
7220756
Mains cable EU
7220760
Mains cable USA
7220761
Mains cable UK
7220762
Upgrade Kit LS 900
7225044
Headrest
Please refer to the instructions for use of headrest
10.2 Legal regulations
• Haag-Streit maintains a quality management system in accordance with EN ISO
13485. The device was developed and designed in accordance with all the
standards listed in chapter 'Observed standards'.
• This is a Class IIa device in accordance with Appendix VIII of EU 2017/745
(Medical Device Regulation). By affixing the CE mark we confirm that our device
complies with the applicable standards and directives.
• You can request a copy of the declaration of conformity for this device from
Haag-Streit at any time.
10.3 Classification
10.3.1 Lenstar LS 900
EN 60601-1
Continuous operation
EN 60825-1
Laser class I
EN 60529
Enclosure protection IP20
EN 62471
Risk group 1
EN ISO 15004-2
Group 2
EU 2017/745 (Medical Device Regulation)
Class IIa
FDA
Class II
10.3.2 T-Cone (option)
EN ISO 19980
Corneal topograph, type B
ANSI Z80.23
Corneal topograph, type B
EU 2017/745 (Medical Device Regulation)
Class IIa
FDA
Class II
