Basic introduction of enteral nutrition pump:
In the European Union, it belongs to Class IIa medical devices and products need to comply with the requirements of MDR regulations for medical devices.
Enteral nutrition pump delivers formula nutrient solution to the patient's digestive tract through a rotating peristaltic pump or linear peristaltic pump system, providing nutrition for those who cannot take food orally. The nutrition pump includes a graphical interface that guides users to set the feed rate, volume, and other feed options for the feed pump.
The enteral nutrition pump usually consists of the following parts (but not limited to):
Power supply system: provides working power for the enteral nutrition pump.
Control system: It is the core unit for intelligent control and management of enteral nutrition pumps, processing detection signals and issuing instructions based on the results.
Infusion execution unit: generates positive pressure on the input pipeline, pushing and controlling the flow of nutrient solution into the patient's body.
L detection unit: processes the detected signal and transmits it to the control system.
Alarm unit: responds to the alarm instructions issued by the control system and emits sound and light alarms.
Human computer interaction unit: including input device and display device, convenient for medical personnel to operate.
Shell structure: As the installation carrier and external protection for various systems, it provides necessary isolation and protection measures
Advantages:
Control infusion speed: The enteral nutrition pump can control the infusion speed of nutrient solution, ensuring that patients receive stable and uniform nutritional support. This is particularly important for patients who need to strictly control the speed and amount of nutrient intake.
Timed and Quantitative Supply: Through preset parameters, the enteral nutrition pump can supply nutrient solution in a timed and quantitative manner, avoiding the complexity and errors of manual operation, and improving the efficiency and accuracy of nutritional support.
Improving nutrient absorption efficiency: The enteral nutrition pump can continuously and evenly deliver nutrient solution, allowing the nutrient solution to flow into the small intestine at a constant speed with gastrointestinal peristalsis, which is beneficial for intestinal absorption and utilization, and improves nutrient absorption efficiency.
Reduce complications: The use of enteral nutrition pumps can reduce complications caused by improper nutritional support, such as reflux, aspiration, diarrhea, etc. At the same time, it can also protect the gastric mucosal barrier and reduce adverse reactions in the gastrointestinal tract.
Success Experience Sharing:
The enteral nutrition pump applied for this time is our company's first nutrition pump to obtain CE certification. After two rounds of rectification since the CE document was submitted in March 2023, it meets all the requirements proposed by the auditor, which is another breakthrough in the field of CE certification for our company.
Familiarity with regulatory and standard requirements, implementing various requirements into documents, effectively communicating with auditors, and understanding their ideas are key to obtaining CE certification.
Choosing a consulting company that is proficient in both product technology and relevant regulatory standards is the key to quickly obtaining a CE certificate. Rui Enni has very mature experience in the field of CE certification, and this CE MDR certificate is already the 11th one.
