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1.2
Qualification of personnele
• The Leica SM2010 R may be operated by trained laboratory personnel only. The instrument is
intended for professional use only.
• All laboratory personnel designated to operate the Leica instrument must read these Instructions for
Use carefully and must be familiar with all technical features of the instrument before attempting to
operate it.
1.3
Intended purpose
The Leica SM2010 R is a manually operated sliding microtome specifically designed for creating
thin sections of formalin fixed, paraffin embedded human tissue specimens of varying hardness
used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. It is intended for
sectioning soft and hard human specimens, as long as they are suitable for being cut manually. The
Leica SM2010 R is designed for in vitro diagnostic applications.
Any other use of the instrument is considered improper!
1.4
Instrument type
All information provided in these Instructions for Use applies only to the instrument type indicated on
the title page. A nameplate indicating the instrument serial number is attached to the rear side of the
instrument.
Leica SM2010 R
Title of the symbol:
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Important Information
Observe the Instructions for Use
Indicates the need for the user to consult the
instructions for use.
Country of Origin
The Country of Origin box defines the Country where
the final character transformation of the product has
been performed.
UKCA Label
The UKCA (UK Conformity Assessed) marking is
a new UK product marking that is used for goods
being placed on the market in Great Britain (England,
Wales and Scotland). It covers most goods which
previously required the CE marking.
Order No.
Indicates the manufacturer's catalog number so that
the medical device can be identified.
Serial number
Indicates the manufacturer's serial number so that a
specific medical device can be identified.
1
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