Functional Description; Description Of Sealing - Conroy Qseal free Operator's Manual

3. Functional Description

This chapter describes how Qseal-free works, where the connectors and the indica-
tions are placed on the unit and their functions.

3.1 Description of Sealing

The indication for use of Qseal-free is a need for seal and separation of tubing or bags
in blood component sets during blood and plasma donation or other blood component
preparation. The target population is determined by the intention of the blood compo-
nents as determined by the trained medical professionals operating the device. The use
of Qseal-free does not limit the initial target population or intended use of the blood
components.
The tube to be sealed is placed in the slot of the sealing module between the electrodes.
When the user presses the button on the battery module, the tube is pressed together
and the sealing procedure will commence automatically. The radio frequency (RF) gene-
rator starts and the energy is transferred from the fixed electrode to the tube, which
melts to a sterilized welding pattern.
During the whole sealing process the yellow seal indicator on the display of the sealing
module is lit. When this light goes out, the sealing is complete and the button may be
released. The intelligent sense control in the sealing module detects, controls, and ad-
justs the necessary sealing activity to give the best sealing quality for the type of tubes
that are being used. See section 1.4 for a description of the different LED indications on
the sealing module display in case of problems.
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