Finger clip oximeters are a type of device in the United States Fang Medical Treat The main purpose of this device is to measure blood oxygen saturation (SpO2) and pulse through non-invasive methods at the fingertips.
Due to the fine red color in the blood Cells, including oxygenated hemoglobin (HbO2) and reduced hemoglobin (Hb), are sensitive to red light (660nm) and red light Outside Line. (910nm) has different absorption abilities. Reduced hemoglobin (Hb) absorbs more red light Outside Line. Less. On the other hand, oxygenated hemoglobin (HbO2) absorbs less red light Outside Line. More. By setting the red LED and red at the same position on the nail oximeter Outside Line. LED lights, when light penetrates from one side of the finger to the other and is received by a photodiode, can generate a corresponding proportion of voltage. After being processed by the microcontroller, the output result is displayed on the LCD screen.
During the epidemic, it was one of the five major components for epidemic prevention, along with masks, thermometers, oxygen concentrators, and ventilators. So during the epidemic, a large number of companies competed to register for certification of blood oxygen meters for export to Europe and America. After comparing with multiple peers, Lingxin Company was finally recognized by our experts Moved by business and sincerity, they chose to entrust us to handle their company's EU CE and US FDA 510K certification registration. Rui Enni fulfilled the client's commission and completed its CE certification before the first half of 2021, and obtained the FDA 510K certification approval by the end of 2021.
After this registration, there are several experiences that can be shared, including:
1) Confirm if the product claims to be suitable for children? If applicable to children, temporary Bed accuracy testing needs to consider appropriate samples; At the same time, consideration should be given to the duration of continuous use and prevention measures Stop the blood circulation caused by long-term pressure on the fingers Environmental issues;
2) Confirm if the product is intended for low perfusion situations? If so, specific requirements of standards or guidelines should be considered for this;
3) If the product has wireless functionality, the app settings and overall product planning need to meet the requirements of relevant countries Home network security Complete basic requirements;
4) Suggestion for Lin Bed accuracy testing and consulting machine Structure Okay. Choose the same company to avoid arguing with each other; Lin Bed testing must meet the program requirements of GCP;
5) When the product exceeds the effective range, an alarm prompt should be displayed, and values outside the effective range should not be displayed to avoid misunderstandings for users.
6) Many companies' oximeters are purchased from solution providers, so it is important to confirm the maturity of the solution provider's products in the market. Many solution providers' designs have not undergone actual implementation Bed verification can lead to inaccurate measurements at the low oxygen level. At the same time, during the certification process, it is necessary for the solution provider to receive a quick response (such as when software or design modifications are needed) in order to ensure that the certification is passed quickly.
