ITC ProTime Microcoagulation System - Manual (Page 4)

4
IMPORTANT LABELS AND SYMBOLS
Before using the ProTime Microcoagulation System, it is essential that the contents of this Operator’s
Manual and any Instructions accompanying the ProTime Cuvettes and Tenderlett Plus incision devices are
read and understood by the operator. These materials make reference to various symbols that are
explained below:
Start/Select
Menu/Scroll
Expiration Date of Cuvettes
Serial Number of Device
Lot Number of Cuvettes/Tenderlett Plus
ITC Catalogue Number of Device
Do Not Reuse – Single Use Only
Upper and Lower Temperature Limitations (For Storage or Use)
For in vitro Diagnostic Use
Attention - Read Accompanying Documentation or Instructions
Consult Instructions for Use
Class II Protection Against Electrical Shock
Input Port for DC Power Cord from AC/DC Power Module - Polarity, VDC
and A Input
Output Port for Data Transfer
Name and Address of Manufacturer
PRINCIPLES OF OPERATION
The ProTime Microcoagulation System measures the PT using fibrin clot formation and detection. The
ProTime cuvette is a self-contained, micro volume reaction cell constructed of precision-molded plastic.
There are two user options within the ProTime Microcoagulation System: the standard ProTime cuvette and
the ProTime3 cuvette. These cuvettes differ from each other in the amount of blood that needs to be
collected and tested.
The standard ProTime cuvette has five micro-channels, which contain the dried reagents required to
perform triplicate testing of the PT assay and two levels of controls. The ProTime3 cuvette has three
functional micro-channels. Two micro-channels perform the controls, and one micro-channel performs the
PT test. The standard ProTime uses the Tenderlett Plus device for performing the fingerstick, and it is
designed to hold 65 µL of blood (approximately 3 drops) needed to fill all five micro-channels. The
ProTime3 uses the Tenderlett Plus LV (low volume) device for performing the fingerstick, and it collects 27
µL of blood (approximately 1 large drop) needed to fill the three micro-channels of the ProTime3 cuvette.
The instrument draws the precise volume of blood into the micro-channels of each cuvette, which contain
thromboplastin and other reagents. An array of LEDs detects the motion of sample/reagent mixtures as they
move through a precision restriction in each channel. The blood is pumped back and forth until a clot
forms, obstructing the channel and slowing the flow of blood. The instrument detects the clot when the
blood movement decreases below a predetermined rate.