USER MANUAL (Instruction for Use) SW 6.1
General Information
Version 6.1.6 dated 2020-01-31 EN Page 16 of 201
IMPORTANT NOTE
An electronic copy of this user manual can be found embedded in the software.
Choose <Help> within AMARIS Application software for User Manual access.
IMPORTANT NOTE
If you have any questions regarding any matters, contact an authorized local
SCHWIND representative or SCHWIND eye-tech-solutions directly for advice.
Refer to chapter 13 Manufacturer / Technical Assistance / Application Support.
IMPORTANT NOTE
The present English manual contains the ORIGINAL INSTRUCTIONS, which are
legally binding. Translations of these must bear the words “Translation of the
Original Instructions”.
1.4 Scope of Documentation
The scope of documentation of the SCHWIND AMARIS includes the “Product Accompanying
Documentation “SCHWIND MEDICAL PRODUCTS”; art.no. 202160x-01 (EN), 202160x-02 (DE),
consisting of:
Medical Apparatus Book “SCHWIND MEDICAL PRODUCTS”
CD-ROM/DVD with “SCHWIND Product Documentation” No. 16316xx, current version,
including the AMARIS User Manual and the relevant manuals as listed in chapter 1.3.
1.5 Declaration of Manufacturer
The SCHWIND AMARIS excimer lasers have been developed according to the applicable
requirements of the European Medical Device Directive 93/42/EEC, as amended (and hence also
according to its German equivalent Medical Device Law MPG
1
). The manufacturer SCHWIND
eye-tech-solutions GmbH has been authorized by the notified body “mdc” (listed at the European
Commission with number 0483) to develop, produce and inspect medical devices for
ophthalmologic purposes and to market and service them.
Conformity of the device with the Directive and MPG is ensured only under the following
preconditions:
Delivery is accomplished by SCHWIND eye-tech-solutions or a distributor authorized by
SCHWIND eye-tech-solutions.
All service and maintenance work is performed only by personnel who are authorized by
SCHWIND eye-tech-solutions.
Accessories, consumables and disposables are only authorized and approved by SCHWIND
or an authorized independent testing authority confirm a completely safe operation and
interaction
_
1)
MPG – Medizin-Produkte-Gesetz is the German Medical Device Regulation
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