USER MANUAL (Instruction for Use) SW 6.1
General Information
Version 6.1.6 dated 2020-01-31 EN Page 14 of 201
1 GENERAL INFORMATION
1.1 System Identification Data
Product name: SCHWIND AMARIS 1050RS
SCHWIND AMARIS 750S
SCHWIND AMARIS 500E
SCHWIND AMARIS
Device description: Ophthalmologic laser equipment for corneal tissue ablation,
refractive surgery (refer to chapter 3.1 Intended Use).
Medical device class: IIb
Laser classification: 4
Software version: 6.1
Serial number: Refer to identification label of the device(s).
CE labelling: 0483
Approved device combination: Refer to chapter 4.15
System requirements: Refer to chapter 5.2
Manufacturer: SCHWIND eye-tech-solutions GmbH
Mainparkstrasse 6-10
63801 Kleinostheim, GERMANY
Delivery: SCHWIND eye-tech-solutions GmbH
or authorized distributor
Current document status: Version 6.1.6 dated 2020-01-31 EN