Qualification Of Personnel; Intended Use Of The Instrument - Leica CM1520 Instructions For Use Manual

Cryostat
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1.2
Qualification of personnel
The Leica CM1520 may only be operated by trained laboratory personnel. Prior to operating the
instrument, the operator must carefully read and understand these Instructions for Use and must
familiarize him/herself with all technical details of the instrument. The instrument is intended for
professional use only.
1.3

Intended use of the instrument

The Leica CM1520 is a high-performance cryostat for routine and research applications in the fields of
biology, medicine and industry. The instrument is used to freeze and section specimen material quickly.
The instrument is not designed for the storage of specimen material. The instrument may only be
operated within the scope of its designated use as described above and as per the instructions given in
these Instructions for Use. The Leica CM1520 is suitable for in-vitro diagnostics (IVD).
Leica CM1520
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Any other use of the instrument is considered improper.
Important Information
Temperature limit for transport
Indicates the temperature limits for transport to which
the medical device can be safely exposed.
Temperature limit for storage
Indicates the temperature limits for storage to which
the medical device can be safely exposed.
Tilt indicator
Indicator to monitor whether the shipment has been
transported and stored in upright position according
to your requirements. With a pitch of 60° or more,
the blue quartz sand flows into the arrow-shaped
indicator window and sticks there permanently.
Improper handling of the shipment is immediately
detectable and can be proven definitively.
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