4
ORTHORA 200
Instruction Manual
The warranty and liability for defects shall be governed by the General
Terms and Conditions of Mikrona Technologie AG as of January 2016
(GTC). The GTC can be downloaded on the website of Mikrona Tech-
nologie AG (www.mikrona.com).
It is essential that this instruction manual be read by every user /
operator before initially operating the device in order to prevent faulty
operation and other damages.
The warranty claims are governed by the GTC. Furthermore, it is re-
commended to pay attention to the recommendations and warnings
within the operating and maintenance instructions.
The consignment comes with a completion certificate. If the comple-
tion certificate is missing, please demand it immediately from your
specialized dealer. You must return the completion certificate within 10
days after commissioning the device to the following address.
Mikrona Technologie AG
Tel.
+41 (0)56 418 45 45
Wiesenstrasse 36
Fax
+41 (0)56 418 45 00
CH-8952 Schlieren
E-Mail [email protected]
The completion certificate enables Mikrona Technologie AG to record
the device for possibly necessary traceability or amendments.
The completion certificate is the basis for possible warranty claims.
Any complaints have to be reported to Mikrona Technologie AG with
the completion certificate within 10 days after the delivery of the treat-
ment unit.
1. Notes
1.1
Warranty / Liability
1.2
Conformity assessment
The product ORTHORA 200 has undergone a conformity assessment
in accordance with the regulation (EU) 2017 / 745 of the European
Parliament and the Council on Medical Devises and meets the essen–
tial requirements of these regulation.
The assessment procedure to which this statement refers complies
with the standards or normative documents EN ISO 6875 / EN ISO
7494-1 / EN ISO 7494-2 / IEC 601-1 / EN 60 601-1.
The treatment unit of the company Mikrona Technology AG is subject
to continuous technical enhancement. Technical properties are there-
fore subject to change and may not correspond with the instruction
manual.
1.3
General information
This instruction manual is an integral part of the device. Always keep
it easily accessible in close range of the device. Compliance with the
operating instructions is condition to intended use and correct opera-
tion of the device. Instruct new employees appropriately and forward
the operation manual to successors.
User / operator safety and failure-free operation of the device is only
provided when using original components. Only use accessories that
are listed in the operation manual or authorized by Mikrona Technolo-
gie AG for this particular purpose (see 10.1. / 10.2. / 10.3.). The com-
pany Mikrona Technologie AG does not warrant secure operation and
function if other accessories are used. Related damages may not be
claimed under this warranty.