Gambro COBE 2991, Справочник по основам

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viii COBE 2991 Cell Processor • Essentials Guide
Notes, Cautions, and Warnings
The following examples show how notes, cautions, and warnings appear in this manual.
Instructions for Use
Indications
The COBE 2991 is a centrifugal system that allows for the extracorporeal processing of cells intended for a range of therapeutic purposes. Cells are
processed to isolate and purify specific populations, remove undesirable substances, and/or concentrate the cells for dispensing into culture or for
therapeutic reinfusion. The COBE 2991 may be used to:
1 Process a unit of whole blood, a unit of packed red blood cells (RBCs), or a volume of salvaged blood to yield a unit(s) of saline-washed red blood
cells for transfusion.
2 Process a large volume of source blood for industrial/commercial uses.
3 Concentrate cells by centrifugal separation.
4 Wash cells with agitation in a desired solution.
5 Remove specific fractions of cell product.
6 Resuspend cell products in a desired solution.
7 Collect young red blood cells.
8 Separate cells using density gradients or centrifugal separation.
9 Carry out other cell processing activities.
Contraindications
There are no known contraindications for use of the COBE 2991.
Warnings
1 Do not use the COBE 2991 in an explosive atmosphere.
2 Due to possible exposure to the hepatitis virus, human immunodeficiency virus, and other infectious agents in the handling of extracorporeal
blood and/or tissue products, adequate precautions should be taken at all times to prevent exposure to and transmission of such agents.
3 The COBE 2991 is not to be connected to a patient or donor. The cell processing set’s fluid pathway is not to be connected to a patient while the
cell processing set is still connected to the COBE 2991.
4 When the centrifuge is spinning, limit access inside the safety boundary of 30 cm (11.8 in) around the perimeter of the COBE 2991 to necessary
individuals.
5 If the cell processor is operated at a room temperature greater than 29.4 °C (85 °F), the temperature of the processed cells in the cell processing
bag may exceed 40 °C (104 °F). The decision to operate the cell processor at a room temperature above 29.4 °C (85 °F) or the decision to use
refrigerated solutions to prevent temperatures of the processed cells from exceeding 40 °C (104 °F) is the responsibility of the user. However, in no
case should the cell processor be operated at a room temperature greater than 35 °C (95 °F).
6 Inspect the sterility outdate on the label of the cell processing set. Do not use the cell processing set if it is outdated.
7 The cell processing set used on the COBE 2991 is not a “closed system.” Therapeutic cell products for transfusion should not be stored for more
than 24 hours in a non-frozen state if they are processed on the COBE 2991.
8 Red blood cells (human) must be transfused within 24 hours after processing with the COBE 2991.
Alerts the user of serious hazards, consequences, or conditions that are likely to result
in a harmful reaction, trauma, or death to the operator or recipient of the processed
blood product, or compromise the quality of the processing procedure.
Caution:
Alerts the user to the possibility of an effect on product quality, or a
problem with the equipment associated with its use or misuse, including equipment
malfunction, equipment failure, damage to the equipment or to other property.
Note: Emphasizes important details.