The disposable extracorporeal circulation path this company manufactures is made of non-toxic medical class PVC. Our disposable puncture needle consists of non-toxic stainless steel and non-toxic medical class PVC tube.
The products must go through the following tests strictly, namely, cytotoxicity test, systematic acute toxicity test, intracutaneous irritation test, sensitization test, hemolytic test, heat source test and sterility test. There will be no side effects or other damages to the human skin, mucous membrane and blood during use. The product has many advantages, such as superior biological performances, transparency, softness and brightness and cleanness, little irritation, no poisonous substances separated, and so it is safe to use. Expected applications The product can be used as blood circulation path for hemodialysis. Precautions for use This product can only be used one time.
After use, it must be disposed of as per the local laws and regulations.
The product with damaged package cannot be used.
Only trained or skillful personnel can operate with the product.
Supervision of a doctor is essential during use. Classification of product The product is a circulatory path to connect the human body orifices so that blood can flow out of the human body and through the extracorporeal circulation path flow back into the human body. According to the classifications under Annex IX to MDD 93/42/EEC, all invasive devices channeling human blood for short-term use belong to Class IIa. Certification of product The product compliance shall be based on the European Medical Device Directive MDD 93/42/EEC and the company has applied for CE approval on the basis of Annex VII and Annex V. |
