ITC IRMA TruPoint Blood Analysis System - Manual (Page 9)

1.1
Section 1
The IRMA TruPoint
®
Blood Analysis System
INTRODUCTION
This section outlines general information about the IRMA TruPoint Blood
Analysis System, and describes the installation process.
INTENDED USE
The IRMA TruPoint Blood Analysis System is intended for use with IRMA
TruPoint cartridges for the in vitro measurement of various critical care
analytes in human whole blood. See Appendix B, Table B-6 for a list of the
analytes that may be measured with the IRMA TruPoint system.
SYSTEM OVERVIEW
The major components of the IRMA TruPoint system are a portable, battery-
operated analyzer, and disposable cartridges that contain sensors and a
calibrant. Cartridges come in a variety of analyte configurations.
Cartridges calibrate with every test using the self-contained calibrant.
Instructions displayed on the interactive touchscreen guide the user through
all steps of the testing process. Patient and sample information can be entered
during analysis. Test results are displayed within approximately 90 seconds
after sample injection. Test results and associated information can be
automatically printed via the on-board printer. Test results and associated
information can be transmitted via serial, LAN10/100, or modem port to the
Integrated Data Management System (idms) or other connected system
capable of accepting ASTM output.
CLIA COMPLEXITY CLASSIFICATION
The IRMA TruPoint Blood Analysis System has a “moderate complexity”
CLIA classification. The optional SureStep®Pro Glucose Module has a
“waived status” CLIA classification (see SureStep®Pro Glucose Module User
Manual).
IMPLEMENTATION
An implementation protocol is available from your service provider upon
request.