SCHWIND Sirius - General Information; Device Identification Data

Short Manual “Calibration” 3.7.01
General Information
Version 3.7.0 / 2019-06-26 Page 3 of 8
1 GENERAL INFORMATION
1.1 Device Identification Data
Product name: SCHWIND SIRIUS
Product description: System combination consisting of a lifting table with Panel PC
(Workstation) and a diagnostic device SCHWIND SIRIUS (rotating
Scheimpflug camera and a Placido disc topographer).
Application: Topography measurements:
 Anterior corneal surface
 Corneal Wavefront
 Keratoconus Screening
Pupillometry, Link to Static Cyclotorsion Control (SCC),
Data export to AMARIS laser systems, IOL Calculation Function,
Tear Analysis, CL Fitting tool, Print function via WLAN
Software version: Phoenix 3.7.01 and higher
Medical Device Class:
Im (SCHWIND SIRIUS)
I (SCHWIND WORKSTATION)
CE labelling of the
manufacturer:
0051 (C.S.O Srl) (SIRIUS)
(SCHWIND WORKSTATION)
Approved device
combination:
Only products specified by SCHWIND eye-tech-solutions acc. to
Declaration of Conformity EWG 12 for system combination:
 Combi / Single Workstation
 SCHWIND PERAMIS
 Corneal Wavefront Analyzer (OPTIKON Keratron Scout)
 SCHWIND CAM
Manufacturer: SCHWIND SIRIUS
C.S.O. Srl – Costruzione Strumenti Oftalmici
Via degli Stagnacci 12/E – 50010 Badia a Settimo, Florenz
www.csophthalmic.com
SCHWIND WORKSTATION
SCHWIND eye-tech-solutions GmbH
Mainparkstrasse 6-10
63801 Kleinostheim, Germany
System intergration and delivery: SCHWIND eye-tech-solutions GmbH or authorized distributor