Area Of Application; Hydroflex Plus Intended Use; Principle Of Operation - tecan HYDROFLEX PLUS Instructions For Use Manual

2. General
2.2

Area of Application

2.2.1

HYDROFLEX PLUS Intended Use

2.2.2

Principle of Operation

16
The HYDROFLEX PLUS is a plate washer for professional use in a laboratory, for
automated washing of 96-well microplates.
The instrument is intended primarily for in-vitro diagnostic use in Enzyme-linked
immunosorbent assays (ELISA) for the semi-automation of plate washing-steps.
The scheduled wash procedure, as well as the type of specimen is defined by the
user selected assay.
The HYDROFLEX PLUS is intended for processing of qualitative and quantitative
assays according to scheduled wash parameters and instrument specifications.
The product is intended for professional laboratory use by trained personnel. The
product is not for home or lay person use.
MANDATORY SYSTEM VALIDATION BY OPERATING AUTHORITY
THE HYDROFLEX PLUS HAS BEEN VALIDATED ON REPRESENTATIVE
ENZYME IMMUNO ASSAYS (EIA) ONLY IN EUROPE. IT IS THEREFORE
THE RESPONSIBILITY OF ANY OPERATING AUTHORITY TO ENSURE
THAT THE HYDROFLEX PLUS HAS BEEN VALIDATED ACCORDING TO
APPLICABLE REGULATIONS FOR EACH SPECIFIC ASSAY USED ON
If the HYDROFLEX PLUS plate washer is used differently from the intended use
mentioned above, the instrument is no longer IVD conform; the user is
responsible for the respective use and the necessary validation.
The HYDROFLEX PLUS can be used to wash plates for a variety of test routines,
mainly in ELISA applications.
The HYDROFLEX PLUS is a microplate strip washer for automated washing,
aspiration, dispensing, and shaking of 96-well microplates.
It can be configured with an 8-way manifold for washing one column of a 96-well
plate at a time, or with a 16-way manifold for washing two columns of the plate
simultaneously.
Each manifold is equipped with a set of aspiration needles to remove liquid from
the wells, as well as with a set of dispense needles to fill wash buffer-solution into
the wells.
An automated plate carrier is used for transporting a 96-well microplate from a
plate-loading position to a wash-position underneath the manifold.
The HYDROFLEX PLUS can be configured with 1-, 2-, or 4-inlet channels for
connecting one-, two-, or four wash buffer-solutions.
During the wash-step, liquid is removed from the wells using the manifold in
combination with an integrated aspiration pump. This pump is running
continuously while the aspiration needles are descending until they reach the
bottom of the wells and the liquid has been removed. For efficient crosswise
aspiration the HYDROFLEX PLUS can use two aspiration positions per well in
96-well plates with a flat-bottom surface.
When the manifold is in the upper position the desired volume of wash buffer-
solution is dispensed into the wells, using the dispense needles in combination
with a dispense pump. For efficient washing of the wells use larger dispense
HYDROFLEX PLUS No. 30199906 Rev. No. 1.1
CAUTION
THE INSTRUMENT.
2022-01