SORIN GROUP BRAT2 Manuel D'utilisation

BRAT2
DESCRIPTION
®
The BRAT Suction Assemblies consist of a suction tip
connector bonded to a dual lumen tube assembly. The small
lumen of the dual lumen tube supplies anticoagulant solution
to the salvaged blood. Flow control for the anticoagulant
solution is achieved with the use of a roller clamp and
universal drip chamber spike. The large lumen tube
connects to the 1/4" inlet port of a blood collection reservoir
and facilitates the transfer of salvaged blood mixed with
anticoagulant from the sucker tip to the blood collection
reservoir.
Contents of this set have been sterilized by ethylene oxide
gas and have nonpyrogenic fluid pathways.
INDICATIONS FOR USE
BRAT Suction Assemblies are intended for use in recovery
and/or processing of autologous blood.
CONTRAINDICATIONS
There are no known contraindications for this product.
However, the use of blood from this device for reinfusion
may be contraindicated, e.g., in the presence of certain
potentially harmful substances (refer to the BRAT2
Operator's Manual for more detail). The responsibility for the
use of the device in all cases belongs solely to the physician
in charge.
WARNINGS
Carefully observe this set for leaks before and during use.
Leakage may result in loss of sterility or loss of blood and/or
fluid. If leakage is observed before or during use, replace
leaking component or retighten leaking connection as
appropriate.
PRECAUTIONS
1. Carefully read these Instructions for Use before using
this product. Refer to the BRAT2 Operator's Manual for
complete instructions.
2. Due to the possibility of operator exposure to
bloodborne pathogens (such as HIV, hepatitis viruses,
bacteria, Cytomegalovirus,
extracorporeal blood circuits, adequate precautions
should be taken at all times to prevent the exposure to
and transmission of such agents.
3. Discard after single use. Do not resterilize any part of
this set, including packaging and wrapping material.
4. Do not use this set if it is damaged, if the sterile
package is damaged or opened, or if the protective
Sorin Group Italia
®
Autologous Blood Recovery
Suction Assemblies
Catalog Numbers
INSTRUCTIONS FOR USE
®
etc.) when handling
007005001 007005400
caps are not in place. Check for loose connections on
preassembled kits.
5. This product is intended for use by trained personnel
only.
6. Use proper aseptic technique while handling this set.
7. If using a spike with capped vent, observe the following:
When using a rigid IV bottle, the cap on the spike vent
should be open to allow air to displace fluid as it drains
from the bottle.
8. Federal law (U.S.A.) restricts this device to sale by or
on the order of a physician.
PROCEDURES FOR USE
007005001
1. Using aseptic technique, prepare a bag or bottle of
anticoagulant solution by mixing 30,000 units of heparin
with a liter of sterile, isotonic normal saline (injection)
solution or lesser amounts in same proportion.
Premixed ACD-A or CPD solutions in bags or bottles
can be used instead of the heparin solution.
2. Using aseptic technique, remove BRAT Suction
Assembly from its package, remove outer wrap, and
pass the inner sterile wrapped assembly to the sterile
field.
3. At the sterile field, unwrap assembly, remove red
protective cover on BRAT Suction Assembly, and
attach connector to suction tip. Pass other end of BRAT
Suction Assembly from the sterile field.
4. Remove blue protective cover on BRAT Suction
Assembly and attach to a 1/4" defoamed inlet port of a
blood collection reservoir.
5. Clamp the solution line. Using aseptic technique, spike
the container of anticoagulant solution and hang it a
minimum of two feet above the surgical field. Fill the
drip chamber 1/4 full. Prior to use, prime the tubing and
reservoir with sufficient solution to wet the blood contact
surfaces (100-200ml). Assure suction is on during the
priming operation.
6. Anticoagulation of salvaged blood should be carried out
by the standard protocol within the institution using the
Suction Assembly. In the absence of such a protocol,
the following guidelines are suggested:
Heparin. Adjust and monitor the flow rate during use
such that one part heparin solution is mixed with four
parts shed blood. A rate of one drop per second (20
drops/ml) is sufficient to anticoagulate an end blood
product in the reservoir of approximately one liter per
hour.
Citrate. Adjust and monitor the flow rate during use
such that one part of ACD-A or CPD solution is mixed
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