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2.
Safety Information
WARNING
The product is delivered in a non-sterile condition. Before first use, as well as
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before each following use, the product must be processed according to a validated
procedure.
Unauthorized modifications of the product are forbidden for safety reasons.
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Due to its composition, the product is not to be used together with other magnetically
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sensitive medical products, devices or instruments (e.g. MRI).
Before using a medical product, assure yourself of its functional safety and proper
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condition via a visual inspection. Do not use the product if any defects, such as
breaks, cracks, deformations or wear, are detected. Particularly important parts such
as tips, notches and all moveable components should be checked with extra care.
The product is a high-precision instrument. Avoid subjecting it to serious strains,
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such as heavy impacts. The product cannot be used if there are visible defects. After
a heavy impact, the product must be checked for defects.
The healthcare provider performing any procedure is responsible for determining the
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appropriateness of using the product and for the specific technique for each patient.
Stryker, as a manufacturer, does not recommend a specific surgical procedure.
The user and/or patient should report any serious product-related incident to both
the manufacturer and the national competent authority where the user and/or patient
is established.
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