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Introduction
Purpose
This manual is intended to assist the user in determining whether a reusable instrument has worn to an extent that it is no longer suitable
for use. This document is provided in conjunction with the cleaning and sterilization instructions for reusable instruments. For additional
reusable instrument instructions, see the Instructions For Use for Biomet 3i Kits and Instruments (Doc No. P-ZBDINSTRP).
Scope
This manual provides information applicable to the reusable instruments used to place and restore dental implants and accessories. This
information is NOT APPLICABLE to instruments labeled as single use (sterile and non-sterile). Devices labeled "for single use only" must not
be reprocessed for re-use as they are not designed to perform as intended after the first usage. When single-use devices are supplied non-
sterile and require sterilization before use, the appropriate sections of P-ZBDINSTRP may be applied unless other specific instructions are
provided in the package insert. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use,
cleaning and re-sterilization may compromise the integrity of the design and/or material leading to diminished safety, performance and/or
compliance with relevant specifications. Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization
release.
Glossary
Condition – A term used to describe damage to a device that can indicate the instrument is no longer suitable for use.
Feedback – Refers to any specific visual, auditory, or tactile feedback that serves as an indicator of decision/action.
Reprocessing – The necessary validated processes including cleaning, disinfection, and sterilization to render a medical device, which has
been previously used or contaminated, fit for its intended subsequent re-use.
Understanding Document Structure
This manual describes several types of wear including:
I.
Bending
II. Discoloration
III. Corrosion
IV. Fracture
The conditions identified above are signs of wear and damage on reusable instruments. The manual is separated by the aforementioned
conditions. Each condition section contains:
•
Images representing the condition category to which it belongs. Images are only a representation of possible wear and/or
damage.
•
Descriptions of the condition shown in the image and content specific to the condition.
•
Potential Effects of Wear on any reusable instrument specific to the condition described, not particularly those shown in the
images provided, to aid in assessing if the instrument is suitable for use.
•
Symbol legend
Suitable for Use
Not Suitable for Use
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