Roche Diagnostics May 2009
Service Manual · Version 9.0 A-5
cobas b 221 system 1 Safety information
Important information
Important information
This Service Manual contains vital warning and safety information.
This instrument is only intended for one area of application which is described in the
instructions. The most important prerequisites for use, operation, and safety are
explained to ensure smooth operation. No warranty or liability claims will be covered
if the instrument is used in ways other than those described or if the necessary
prerequisites and safety measures are not observed.
The instrument may be operated only by persons whose qualifications enable them to
comply with the safety measures that are necessary during operation of the
instrument.
To avoid direct contact with biological materials, always wear appropriate protective
equipment such as lab clothing, protective gloves, safety glasses and, if necessary, a
face mask. Additionally a face shield must be worn if there is a potential of a
splashback. Appropriate disinfection and sterilization procedures must be followed.
To avoid direct contact with biological materials, wear lab clothing, protective gloves,
protective glasses and, if necessary, mouth cover and apply disinfection and
sterilization procedures.
Adjustments and maintenance performed with removed covers and connected power
may be attempted only by a qualified technician who is aware of the associated
dangers.
Instrument repairs are only to be performed by the manufacturer or qualified service
personnel.
Only accessories and supplies either delivered by or approved by Roche are to be used
with the instrument. This ensures the performance and measuring accuracy of the
unit. These items are manufactured especially for use with this instrument and meet
the highest quality requirements.
Operation of the instrument with solutions whose composition is not consistent with
that of the original solutions' can negatively affect, above all, the long-term
measurement accuracy. Deviations in the composition of the solutions can also
decrease the service life of the electrodes.
The quality control requirements must be completed at least once daily for safety
reasons. Because the measurement results delivered by the instrument depend not
only on the instrument's proper operation but also on a variety of external influences
(for example: preanalytics), the results produced by this instrument should be
appraised by an expert before additional measures are taken based on the results.
Explanation
Meaning: Important, see the cobas b 221 system Instructions for Use.
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