国: ベラルーシ
言語: ロシア語
ソース: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
MACOPHARMA, ФРАНЦИЯ
изделия медицинского назначения
MACOPHARMA
2021-01-28
NOTUNI15 2015-03-19 NOTUNI15 2015-03-19 DISPOSABLE SET FOR PATHOGEN INACTIVATION OF PLASMA ENGLISH DESCRIPTION The ZDV THERAFLEX MB-Plasma system intended for the inactivation of pathogens in plasma contains: - a clamp (1), a transfer line (2), a Methylene Blue pill (3), a plasma storage bag (illumination bag) (4), a Methylene Blue filter (5) (BLUEFLEX), a clamp (6) and a plasma storage bag (7). Volume of plasma to be connected: 220-315 ml. INDICATIONS - The ZDV system is intended for the inactivation of pathogens in plasma leucoreduced exclusively using a PLAS4 or Miniplas filter and using Macotronic illumination device with Methylene Blue retention. - The ZDV system contains 85 µg of Methylene Blue as described in the European Pharmacopeia. CONTRAINDICATIONS Do not use treated plasma in case of previous allergic reactions to methylene blue or derivatives . PRECAUTIONS - Use the kit at a temperature between 15-30°C. - Keep the illumination bag containing plasma and methylene blue away from light before illumination. - Keep the kit and its components away from sharp objects. - Do not add any label on the illumination bag (4). - Do not use if the overwrap and/or system shows any sign of deterioration. - Check that the Methylene Blue pill is in its housing. - Do not use air vent for plasma transfusion. - Single use disposable set. Do not re-use. Risks associated with re-using this product are: contamination of the product by another blood product, septic risk, absence of inactivating agent. All or part of this medical device is made of PVC plasticised with DEHP. According to some studies, DEHP could potentially be harmful to the reproductive system of male foetuses. The prescriber is solely responsible for choosing to use this device on women who are either pregnant or breast-feeding, or on young male infants. Nevertheless, DEHP-plasticised PVC is in compliance with the European Pharmacopoeia. - ALL MANUFACTURING PROCESSES AND ALL COMPONENTS IN CONTACT WITH THE DONORS, THE USERS AND THE BLOOD COMPONENTS DEDICATED 完全なドキュメントを読む