2 qualification of personnel, 3 intended use of instrument, 4 instrument type – Leica Biosystems CM1520 User Manual

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

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Instructions for Use V1.3 – 10/2012

1.

Important Information

1.4 Instrument type

All information contained in these Instructions

for Use applies exclusively to the instrument type

indicated 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

Fig. 1

1.3 Intended use of instrument

The Leica CM1520 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 speci-

men 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 CM1520 is also suitable for IVD

(in vitro diagnostics).

Any other use of the instrument is considered improper.

In no case does chemical disinfection replace the manual protection as per the applicable lab-

oratory regulations (i.e. safety goggles, gloves, laboratory coat and mask must be worn).

1.2 Qualification of personnel

Only trained laboratory personnel may operate the Leica CM1520. 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!

supplemented by appropriate instructions to en-

sure 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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