Комплект контейнеров для заготовки крови и ее компонентов с целью последующего фракционирования крови на компоненты, хранения компонентов крови, замораживания плазмы и клеток крови, размораживания и отмывания клеток крови: растворы

País: Bielorrússia

Língua: russo

Origem: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Disponível em:

MACOPHARMA, ФРАНЦИЯ

Classe:

изделия медицинского назначения

Fabricado por:

MACOPHARMA

Data de autorização:

2021-01-28

Características técnicas

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