2 qualification of personnel, 3 intended use of instrument, 4 instrument type – Leica Biosystems CM1860/CM1860 UV User Manual

Page 8: Qualification of personnel, Intended use of instrument, Instrument type, Important information

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Instructions for Use V1.4 – 10/2012

1.

Important Information

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

Fig. 1

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).

Any other use of the instrument is considered improper.

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).

1.2 Qualification of personnel

Only trained laboratory personnel may operate the Leica CM1860/CM1860UV. 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.

The nameplate shown here is intended as an

example only!

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.

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