Instructions for Use
Rotterdam-Midline Distractor / Bologna-Midline Distractor
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Product Liability and Warranty
1.1
General Information
We thank you for having decided to buy a KLS Martin product. This product carries the CE
mark, which means that it satisfies the essential requirements laid down in the EC Directive
concerning medical devices.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · www.klsmartin.com
1.2
Intended Use
The KLS Martin distraction systems are intended for lengthening or generating bone.
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The distraction systems are made up of a great variety of components and accessory
parts.
Various surgical techniques and materials are optionally available for distractor fixation. It
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is the user's (treating physician's or surgeon's) responsibility to determine and select the
correct type and configuration of the distraction system to be used in compliance with
anatomical and functional patient requirements.
Gebrüder Martin shall not be responsible for complications caused by wrong indications,
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wrong implant selection, incorrect combination of system components, use of inadequate
operating techniques, limitations of the treatment used, or lack of hygiene.
All distraction components, instruments and accessories must be available in ready-for-use
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condition.
The product must be used according to indication.
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V. 3.0
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