USER MANUAL
(Instruction for Use)
SW 2.9
General Information
Version 2.9.7 dated 2020-12-23
Page 9 of 75
_
IMPORTANT NOTE
The present 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 includes the includes the Accompanying Documentation
“SCHWIND MEDICAL PRODUCTS”, art.no. 202160x-01 (EN), 202160x-02 (DE), consisting of:
Medical Apparatus Book “SCHWIND MEDICAL PRODUCTS”
CD-ROM/DVD “SCHWIND Product Documentation” art.no. 163160x containing the
appropriate Carriazo-Pendular documents as listed in chapter
1.5
Declaration of Manufacturer according to the European MDD 93/42/EWG
for Microkeratome Carriazo-Pendular
The Carriazo-Pendular microkeratome has 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 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
IMPORTANT NOTE
The
Declarations of Conformity
for Carriazo-Pendular microkeratome and as
System Combination with tubings and lid speculum can be found on the Product
Documentation DVD in the SCHWIND Accompanying Documentation
folder
“SCHWIND MEDICAL PRODUCTS”
.
