iv
Operating this device
When operating this device, follow standard quality control procedures and
the guidelines presented in this section.
Intended use
Waters
®
designed the 2545 Binary Gradient Module to manage solvents under
MassLynx™ software control in Waters AutoPurification Systems.
Calibration
To calibrate HPLC systems, follow acceptable calibration methods using at
least five standards to generate a standard curve. The concentration range for
standards should cover the entire range of quality-control samples, typical
specimens, and atypical specimens.
To calibrate mass spectrometers, consult the calibration section of the
operator’s guide of the instrument you are calibrating.
Quality control
Routinely run three quality-control samples that represent subnormal,
normal, and above-normal levels of a compound. Ensure that quality-control
sample results fall within an acceptable range, and evaluate precision from
day to day and run to run. Data collected when quality control samples are out
of range might not be valid. Do not report these data until you are certain that
the instrument performs satisfactorily.
Warning: Although some of the modules in the AutoPurification
System might carry IVDD labels, the system as a whole is not
intended for clinical use.