COBE 2991 Cell Processor • Essentials Guide ix
9 The waste collection bag is not for storage of products to be transfused.
10 Gambro BCT will not be responsible for product processed in the cell processing set or for patient safety if the procedures used to install and
utilize the cell processing set are other than those specified by Gambro BCT, Inc.
11 Gambro BCT’s recommended use of the COBE 2991 and Gambro BCT’s warranty on the processing sets are limited to applications that do not
exceed the COBE 2991’s functional specification limit of
0 to 3000 rpm (1000 rpm -0% to +10%; 3000 rpm -0% to +5%).
12 Use only cell processing sets manufactured by Gambro BCT for the COBE 2991.
13 The strictest attention should be given to the following precautions when the COBE 2991 is used to wash salvaged shed blood.
Careful attention must be given to the instructions/protocols provided by the manufacturer of the shed blood collection system.
• The washed shed blood must be reinfused following standard transfusion practice.
• The collection of shed blood in the presence of contamination or malignancy may result in the infusion of bacteria and/or tumor cells into
the patient.
• The decision to use the cell processor in all cases is the responsibility of the physician in charge.
• The following complications have been known to develop during reinfusion of shed blood:
– Blood trauma
– Blood coagulation
–Coagulapathies
– Particulate matter and air emboli
– Septicemia
• Autologous transfusion is not intended to replace homologous blood transfusion. Its purpose is to use blood lost by the patient during an
elective or emergency procedure, thus reducing the requirement for homologous blood. Therefore, except under emergency situations, the
physician in charge should not attempt to use autologous transfusion without the usual quota of donor blood available.
14 If the centrifuge bowl or overflow bottle contains cell product or processing/wash solutions that have spilled, treat this material as a potential
biological hazard. Discard the contents according to your institution’s standard operating procedures for biological hazards. Clean the bottle with
an appropriate cleaning solution and place it back in position, with the overflow tubing inside the bottle.
15 To reduce the risk of electric shock, DO NOT use an adapter that breaks the protective ground connection.
16 The collection and transfusion of granulocyte concentrates from single units of fresh blood is an investigational procedure. The decision to collect
and transfuse granulocyte concentrates is the sole responsibility of the physician in charge.
17 The collection and transfusion of young RBCs from a single unit of fresh blood is an investigational procedure. The decision to collect and
transfuse young RBCs is the sole responsibility of the physician in charge.
18 Only trained technical personnel should open the front and right panel doors. Only qualified service personnel should open the left and rear panel
doors. A special tool may be required to open the panel doors.
Cautions
1 The COBE 2991 should be operated only by technically trained personnel.
2 Turn off the COBE 2991’s power when the device is not in use.
3 The cell processing set may be subject to occasional failure, which could result in the loss of cell product. It is very important that the operator
follows the instructions in the operator's manual for setup and operation, and carefully observes for leaks during the use of the cell processing set.
4 The cell processing set is intended for single use only.
5 The cell processing set’s fluid pathway is sterile and nonpyrogenic. Do not use the set if the end caps are not in place.
6 If using an external pump to deliver fluid to the cell processing bag, monitor the volume added to the cell processing bag. This is necessary to
prevent exceeding bag capacity and potentially compromising the cell processing set.
7 Use aseptic technique while connecting cell product and processing/wash solutions to the cell processing set.
8 Red blood cell (RBC) products prepared on the COBE 2991 may require a microaggregate filter for transfusion.
9 Do not operate the COBE 2991 unless the centrifuge bowl cover is properly locked in place.
10 Do not push down on the seal weight when placing the rotating seal in its proper position. This may damage the rotating seal.
11 Do not operate the COBE 2991 with the centrifuge bowl empty, with an empty cell processing bag, or without the priming cushion. This will
cause the flexible diaphragm to rupture.
12 When you are priming without the priming cushion, you must set the CENTRIFUGE SPEED control to zero. This prevents possible damage to
the flexible diaphragm.
Note: To minimize the complications resulting from particulate matter infusion, the
use of an in-line microaggregate filter is strongly recommended.
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