Qualification Of Personnel; Intended Use Of Instrument; Instrument Type - Leica CM1860 Instructions For Use Manual

1. Important Information
1.2

Qualification of personnel

Only trained laboratory personnel may operate the Leica CM1860/CM1860 UV. Prior to operating the
instrument, the operator must thoroughly read and understand these Instructions for Use and must
familiarize him/herself with all technical details of the instrument.
Despite chemical and/or UV-light disinfection, adequate safety measures as per the applicable
laboratory regulations must still be taken (i.e. safety goggles, gloves, laboratory coat and mask
must be worn). These disinfections mean a reduction in the number of germs of at least 99.99 %
(see certificate on the Leica website).
1.3

Intended use of instrument

The Leica CM1860/CM1860UV is a high-performance cryostat with disinfection system for routine and
research applications in biology, medicine and industry. The instrument is used to freeze and section
specimen material quickly. The instrument is not designed for unsupervised 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 CM1860/CM1860UV
is also suitable for IVD (in vitro diagnostics).
1.4

Instrument type

All information contained in these Instructions for
Use applies exclusively to the instrument type in-
dicated on the title page. A nameplate bearing the
instrument serial number (SN) is attached to the
back of the instrument.
These Instructions for Use include important
instructions and information related to the oper-
ating safety and maintenance of the instrument.
The Instructions for Use are an important part of
the product, and must be read carefully prior to
startup and use and must always be kept near the
instrument.
If additional requirements on accident prevention
and environmental protection apply in the country
of operation, these Instructions for Use must be
supplemented by appropriate instructions to ensure
8
Any other use of the instrument is considered improper.
compliance with such requirements.
Proper and intended use includes the observance
of all instructions in the Instructions for Use and
compliance with all inspection and maintenance
instructions.
The nameplate shown here is intended as an
example only!
Instructions for Use V 1.6 RevI – 10/2016
Fig. 1