Section 1: System Description; Intended Use; Principle Of Clot Detection; Data Storage - Medtronic ACT Plus Gebrauchsanweisung

Section 1: System Description

The Medtronic ACT Plus
microprocessor-controlled electromechanical coagulation instrument intended for
in vitro determination of coagulation endpoints in fresh and citrated whole blood
samples. The ACT Plus
Medtronic disposable cartridges: High Range ACT, Low Range ACT, Recalcified
ACT, and High Range Heparinase.

Intended Use

®
The ACT Plus instrument is intended for in vitro diagnostic testing in either a
hospital laboratory setting or a point of care (decentralized) setting (eg, in the
operating room, cardiac catheterization lab, intensive care unit, or clinic, etc.).

Principle of Clot Detection

Test reactions occur at 37°C ±0.5°C in single use cartridges placed in the Actuator
Heat Block Assembly. Fibrin formation is the endpoint of tests performed on the
®
ACT Plus instrument. Fibrin formation is detected by measuring the rate of fall of
the plunger-flag mechanism in each cartridge channel. The plunger assembly falls
rapidly at programmed timed intervals through an unclotted sample. The fibrin web
formed during clotting impedes the fall rate of the plunger and is detected by a
photo-optical system located in the ACT Plus
Tests are performed in duplicate, and the clotting time results are displayed on the
red Light Emitting Diode (LED) display and on the Liquid Crystal Display (LCD)
screen of the ACT Plus

Data Storage

®
The ACT Plus stores a total of 1000 test results, any combination of patient and
quality control tests. Test data is stored in the order performed. Patient and quality
control test data may be transferred to the ACT Plus EDM (external data manager)
using the floppy drive or USB port. Test data may be transferred to a laboratory or
hospital information system using the serial communication port with vendor
neutral connectivity software.

Test Cartridge

Test cartridges for the ACT Plus
reaction chamber, and the plunger assembly.
®
ACT Plus Operator's Manual
®
Automated Coagulation Timer is a
®
instrument is designed for use with the following
®
instrument.
®
instrument consist of the reagent chamber, the
®
instrument's actuator assembly.
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