TEM-A has the unique feature of the automatic calibration before every test. When you press the virtual command “START”, the TemaWin software takes charge, it notes the mechanical position of the sensor at rest and assigns to it a zero value, then it allows the analysis to begin. This beginning is evidenced by the lighting of the yellow LED on the front panel of the instrument and by the activation of the virtual command “STOP” on the computer display. Differently than other similar instruments, TEM-A is calibrated also for the end scale of 100 to ensure that the signal has the same linearity throughout its range : this is done mechanically at the factory and this mechanical calibration will remain stable in the unit unless the sensor is mechanically manipulated, which cannot be done accidentally since it is blocked when not in use.
Other thromboelastography instruments calibrate with a known spring of low value, being unable to calibrate the end scale of 100. Such calibration is not appropriate, since verifying the measurement at a low amplitude ( i.e. 20mm.) which is very near to the zero, does not verify the linearity of the sensor in the upper ranges (from 20 to 100) of its function.
The stability of the mechanical end scale calibration and the automatic zero calibration before every test does away with the need for periodical (daily) manual calibration of the electronics and reduces the requirements for quality control.
In fact, rather than having to run two-point QC tests to validate the instrument, as needed in instruments calibrated at the low range of the scale, in TEM-A it is sufficient to run a single QC test that verifies the zero, i.e. that the automatic cal is efficient, and an intermediate measurement of any desired amplitude (better if >50).
Calibration and Quality Control issues
New QC: TemaTrol
For this purpose, our Research has developed new materials for quality control, the TemaTrol, a 100% vegetable combination of an active powder and a diluent that, when mixed together, mimic the behaviour of clotting blood with a high specificity and sensititvity within the tolerance range, and this tolerance range, is much smaller than the usual QC tests made of animal/human blood/derivates that, due to their inherent variability, have ranges that can be as high as 50%. TemaTrol is environmentally compatible, does not require use of gloves and can be disposed of as normal waste. The resulting graph and data confirm the correct operation of the instrument by the initial zero line and the subsequent MA within the range specified on the TemaTrol package.
