ITC IRMA TruPoint Blood Analysis System - Manual (Page 164)

F.2
WARNINGS AND LIMITATIONS OF USE:
• Read instructions for the IRMA TruPoint system and capillary device
before use.
• For in vitro diagnostic use only.
• For capillary sample collection and analysis. This device is not sterile and
is not intended to be used as a syringe.
• Blood sample collection must be performed under proper medical
supervision. Avoid excessive squeezing of the puncture site to prevent
sample hemolysis and contamination of the sample with tissue fluid.
Tissue fluid may dilute the sample.
• The capillary tube sample channel must be completely filled with blood and
contain no air bubbles. If the sample channel is not completely filled (i.e.,
blood is not in contact with the white plug), the sample may run out of the
device.
• The presence of bubbles in the sample channel may result in erroneous or
suppressed results. If bubbles are present in the sample channel, remove
them by angling the tip downward and allow the sample to flow back
towards the tip to push the air bubble out the tip, or blot sample from the
device. Refill the device with additional sample.
• If using a cartridge with a Cal cap, let the sample sit in the capillary tube
for one minute following collection before attaching the capillary tube to
the cartridge. For all other cartridge types, analyze the sample immediately
following collection, or place a luer cap (P/N 033501) on the tip of the
capillary tube to prevent room air contamination. Properly label the device
and analyze the sample within
5 minutes .
• Do not ice samples collected in this device.
• Use of this device with instruments other than the IRMA TruPoint Blood
Analysis System must be validated to ensure proper sample volume and
functionality.
STORAGE
Store at room temperature away from direct sunlight.