Configurations - BIO RAD Bio-Plex Pro Instructions For Use Manual

The instrument is a general purpose laboratory instrument (Europe) and is a Class I
General Controls medical device (U.S.) for the processing of samples from biological
and non-biological origin.
The wash stations are designed primarily for the processing of Bio-Plex and other
xMAP assays. The instruments may also be used for the processing of ELISA assays
and the washing of adherent cells.

Configurations

Both wash stations are delivered with the magnetic carrier installed and the
appropriate programs for performing the wash steps of magnetic bead based assays.
The Bio-Plex Pro II is also supplied with a vacuum manifold plate carrier to perform
wash steps for standard Bio-Plex assays and other non magnetic xMAP assays. In
order to do this, you must install the vacuum manifold plate carrier and connect the
appropriate tubing as indicated in Changing the Plate Carrier on page 23. You must
also redefine the configuration of the instrument using the keypad as outlined in
Complete Instrument Keypad Functions on page 43. Use the appropriate standard
programs.
Both instruments can also be used to process other plate-based assays. If you wish
to do so, you can leave the magnetic carrier in place. If you have concerns about the
magnetic fields affecting your assay, you can replace the magnetic plate carrier with
the standard plate carrier. Make sure you reconfigure the system as outlined in
Complete Instrument Keypad Functions on page 43.
Bio-Plex Pro and Bio-Plex Pro II Wash Stations
Caution
Unauthorized modification of the instrument, any of its options and/or
components as well as on any corresponding software or spare parts
will result in a loss of warranty and a potential loss in instrument
performance.
Caution
It is important to understand that the proper installation of the
instrument and software alone will not ensure compliance with national,
regional, or local regulations. A range of policies and standard operating
procedures according to applicable regulations must additionally be
established.
Caution
Mandatory System Validation by Operating Authority
The instrument has been validated on representative Enzyme
Immunoassays (EIA) only in Europe. It is therefore the responsibility of
any Operating Authority to ensure that the instrument has been
validated according to applicable regulations for each specific assay
used on the instrument.
About the Instrument
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