Gambro COBE 2991, Справочник по основам

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Description
The COBE ® 2991 Cell Processing Set is a disposable product used in the processing of blood
and cellular components
.
Intended Use
The COBE
® 2991
Blood Cell Processing Set is intended for use with the COBE
® 2991
Blood
Cell Processor to process blood , and cellular components .
Please refer to the COBE
® 2991
Blood Cell Processor Operator
'
s Manual for a complete listing
of warnings
,
cautions and operating instructions
.
Warnings
1.
The COBE
2991
Blood Cell Processing Set is not to be patient or donor connected
.
2. The tubing 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.
3.
Red blood cells
(
human
)
must be transfused within
24
hours after processing with the
COBE 2991 Blood Cell Processor .
4.
The waste collection bag is not for storage of products to be transfused
.
5. Terumo BCT will not be responsible for product processed in the COBE 2991 tubing set
or for patient safety if the procedures used to install and utilize the tubing set are other
than those specified by Terumo BCT , Inc .
6.
Tubing sets manufactured by Terumo BCT contain DEHP
.
Results from selected studies
of rodents exposed to DEHP ( typically via an oral route ) have shown potentially harmful
effects to male reproductive organs during fetal development
.
Because of this
,
patient
groups that include pregnant or nursing women and children are considered to be most at
risk to potential harmful effects of exposure to DEHP
.
However
,
no studies performed to
date involving other mammals and humans exposed to intravenous DEHP have shown
similar results
.
Regulatory bodies have noted that the risk of not doing a needed procedure
is far greater than the risk associated with exposure to DEHP . It is the responsibility of
treating physicians to balance this risk for their patients
.
Cautions
1. Not for Reuse : Tubing sets manufactured by Terumo BCT bearing the not for reuse
symbol are intended for single use only and are not intended to be reprocessed or reused
.
Terumo BCT cannot ensure the functionality or sterility of the set if it is reprocessed or
reused
.
2. The tubing set fluid pathway is sterile and nonpyrogenic .
2