Dimeda instruments INSTRUCTION MANUAL
INSTRUCTION MANUAL
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Field of application
All reusable surgical instruments, which
• consist of only one piece
• may contain simple joints or
• simple movable parts
• may be composed of several exchangeable parts
Basics
These instructions cannot replace training, carefulness and the user‘s knowledge of the state-of- the-art-technology. We therefore assume that the respective legal rules, standards and recommendations (e.g. those of “RKI”
or also of “AKI”) are known (see „Standards/References“).
ATTENTION: READ THESE INSTRUCTIONS VERY CAREFULLY BEFORE YOU PREPARE AND
USE THE PRODUCT FOR THE FIRST TIME.
Labelling
Item or order number
Batch number
Inscription for non-sterile products
Caution, note the accompanying documents
European approval symbol
Intended use
All reusable surgical instruments supplied by Dimeda Instrumente GmbH may only be used for the purpose
of which they are designed, by adequately qualified personnel only. The proper surgical technique for the use
of the instrument is the responsibility of the surgeon. Moreover, the surgeon is responsible for an appropriate
training and sufficient information for the operating theatre staff as well as for an adequate expertise with the
handling of the instruments.
Restrictions
Frequent reprocessing has little impact on the lifetime, which is generally determined by wear and damage
incurred during the intended surgical use, or by misuse. After the instrument‘s utilization on patients with
Creutzfeldt-Jacob disease (CJD) or its variations we refuse all responsibility for reutilization! We recommend
destroying the instruments. If you reprocess and reutilize the instrument nevertheless, even according to the
RKI2-guidelines, you bear all responsibility. Instruments containing aluminum get damaged by alkaline cleaners
>pH 7!
Warning
The instruments are generally delivered unsterile. After having received the products, please check their identity,
completeness, intactness and functioning before you reprocess them. It is indispensable to inspect the instruments prior to use for breakage, deformation, damage and proper functioning. In particular, you have to check
parts such as cutting edges as well as all movable parts. Instruments that are fully worn, corroded, deformed,
porous or otherwise destroyed have to be rejected.
Combination with other products/instruments
If instruments are reassembled after having been disassembled, the individual parts must not be replaced by
parts of other manufacturers, even if a part is exchangeable because of the product‘s specific function (e.g.
different inserts). We recommend ordering equipment (e.g. cleaning and care products) at Dimeda Instrumente
GmbH, too.
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www.dimeda.de
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