In this technology section, a medical sensor works in combination with a disposable cuvette, in order to monitor online the oxygen saturation, hematocrit, hemoglobin and blood temperature, with the aim of continuously providing information on the blood condition.
These sensors are based on an opto-electronic engine which uses solid-state light sources LED at two different wavelengths for the measurement of oxygen saturation and hematocrit.
The measure is based on a ratiometric principle of measured scattered light at these two wavelengths.
One wavelength is selected at an isosbestic point of reduced hemoglobin or oxyhemoglobin to eliminate the effect of variable blood oxygenation.
At this isosbestic wavelength, the amount of light adsorption is independent from the amount of oxygenated or reduced hemoglobin in the red cells. The ratiometric principle of measured scattered light at these two wavelengths is used in order to provide the best sensitivity for the detection of small blood amounts.
The second wavelength is chosen at a point of the spectra where there is a great variation in light absorbance for hemoglobin or water, used for the quantification of oxygen saturation and hematocrit, respectively.
Other light source LEDs are used for the status/error code detection. For temperature measurement an IR-sensor integrated thermopile is implemented.
Blood leakage detection sensors are categorized in this technology. They are devices based on an opto-electronic engine which uses two solid-state light sources LED in the UV (Ultraviolet) and IR (Infrared) range.
In this technology section, a medical sensor works in combination with a disposable cuvette and a sensor spot, in order to monitor the partial oxygen pressure and the blood temperature, with the aim of continuously providing information on the blood condition.
This sensor measures partial pressure of Oxygen (pO2) via an optical fluorescence technology.
The light from an LED excites the oxygen sensitive element embedded in the arterial sensor spot to emit fluorescence: the sensor measures the decrease/quenching of the fluorescence signal and correlates the degree of quenching to the arterial oxygen partial pressure of the blood.
Reduction of fluorescence lifetime corresponds to an increase of the oxygen concentration, allowing the quantification of free oxygen in blood to get pO2 (mmHg).
For temperature measurement an IR-sensor integrated thermopile is implemented.
As a first step, an analysis of customer’s needs is performed when a request from the market comes. The analysis consists of understanding if we can meet the customer’s request with a ready-to-use sensor or if it involves a hardware and firmware customization
If the request coming from the market can be satisfied, in all the necessary features and functionalities by a Ready to use Sensor, we proceed with a sales quotation, which can also include a custom calibration.
If the customer’s needs cannot be met by our off-the-shelf sensors, a detailed analysis is performed and the following aspects are defined in collaboration with the customer:
Datamed provides inputs and support development of the HW. It evaluates and verifies the design and first prototypes.
Datamed designs by itselfs the HW of both device and cuvette. It follows the molds development.
Datamed develops custom FW according to specific internal protocols and customer requirements
Datamed develops a custom calibration procedure for each blood sensor type to reach the defined measurement ranges and accuracies.
The complete manufacturing and calibration process, together with the FW, are validated by a dedicated plan.
Once the development phase is completed and the product is validated, a design transfer to the production factory site is performed in order to start the device mass production. A first article inspection is performed on the initial mass production.