Indications For Use; Procedures For Use - SORIN GROUP BRAT2 Manual Del Usuario

BRAT2 Bowl Processing Set (see Figure 2)
The BRAT2 Bowl Processing Set consists of a Baylor centrifuge
bowl (F), tubing set with cartridge (G, I), reinfusion bag (H), and
waste bag (J). The centrifuge bowl with tubing set provides for the
separation, concentration, and washing of red cells. The waste bag
has a ten liter capacity with a drain valve (K) so that the bag can
be emptied during or after the procedure. It also has a slide clamp
(L) on the inlet port. The blood reinfusion bag is approximately one
liter in capacity with two tamper-proof access sites and one female
port connector.
The Standard Volume Bowl has a processing volume of
approximately 250 ml, and the Low Volume Bowl has a processing
volume of approximately 135 ml.

INDICATIONS FOR USE

The BRAT2 Procedure Set (comprised of the BRAT Suction
Assembly, the Blood Collection Reservoir, and the BRAT2 Bowl
Processing Set) is 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
1. To reduce the possibility of air or particulate embolism, Sorin
Group Italia recommends the use of reinfusion protection
devices, including microfilters, when infusing blood products.
Failure to use reinfusion protection devices, including an in-
line filter, may result in air or particulate embolisms that are
potentially harmful to the patient.
2. Do not reinfuse red blood cells or other blood products from
any bag connected to the autologous transfusion circuit,
unless that bag is a secondary transfer bag which is clamped
off from the circuit at the time the fluid is being reinfused.
Prior to administering any fluid to the patient, all air should be
carefully removed from the fluid bag. Failure to properly
isolate and remove air from fluid bags may result in air
embolism to the patient.
3. Carefully observe this Procedure 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 the leaking component or retighten the leaking
connection as appropriate.
4. The American Association of Blood Banks recommends the
following guidelines for expiration of salvaged blood
a. If not transfused immediately, units collected and
processed under sterile conditions with a device for
intraoperative blood collection that washes with 0.9%
saline, USP, shall be stored under one of the following
conditions prior to initiation of transfusion:
• At room temperature for up to 4 hours after end of
processing.
• At 1° C to 6° C for up to 24 hours, provided that
storage at 1° C to 6° C is begun within 4 hours of
end of processing.
b. The transfusion
postoperative or posttraumatic conditions shall begin
within 6 hours of initiating the collection.
5. Failure to maintain adequate anticoagulation during blood
collection can cause excessive clotting in and possible
clogging of the collection reservoir or centrifuge bowl.
1
American Association of
Perioperative Autologous Blood Collection and Administration. 2
Edtion. Bethesda, MD. 2005. Reference Standard 5.1.7A
PRECAUTIONS
1. Carefully read these Instructions for Use before using this
product. Refer to the BRAT2 Operator's Manual for complete
instructions.
English.
1
:
of shed blood collected
Blood Banks. Standards
2. Due to the possibility of operator exposure to bloodborne
pathogens (such as HIV, hepatitis viruses, bacteria,
Cytomegalovirus, etc.) when handling 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 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. 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. If the blood inlet pressure rises, or if blood exits over the top
of the filter element, the filtration capacity of the reservoir has
been exceeded and the reservoir should be replaced
immediately.
9. This reservoir is not vented. When pumping into the reservoir,
the yellow vent cap must be removed from the 1/4" perimeter
slip port to prevent inadvertent pressurization of the reservoir.
10. When used with a vacuum system for suction, it is
recommended that the vacuum level not exceed 150 mmHg
as a higher vacuum level may result in higher hemolysis.
Users of the Blood Collection reservoir should verify the
accuracy and functioning of the suction regulator
activating under-pressure relief valve is provided to prevent
implosion of the device if exposed to a sudden, deep vacuum.
11. In the event of decreased patient Anti-thrombin III levels,
heparin anticoagulation may be ineffective. Consult the
physician regarding an alternative anticoagulant solution.
12. Avoid aspiration of any calcium containing IV solutions (e.g.
Lactated Ringers) when citrate anticoagulation is used.
Aspiration of calcium containing IV solutions may cause
clotting in the Blood Collection Reservoir
13. If used with a non-Sorin Group device, the user is responsible
for ensuring that a secure and appropriate connection exists
between the Reservoir Outlet Port (D) and the blood
processing system wash set.
14. It is recommended that intraoperative and postoperative
autologous blood be processed. Refer to the BRAT2
Operator's Manual for complete instructions on the use of this
device with that processing system.
15. Overfilling the reinfusion bag may cause it to rupture.
16. The BRAT2 machine must be configured for the proper bowl
size (250 ml or 135 ml) prior to use.
17. Only sterile normal saline (injectable or designated for cell
processing) should be used as a wash solution.
18. Federal law (U.S.A.) restricts this device to sale by or on the
order of a physician.
2
American Association of Blood Banks.Guidelines for Blood
Recovery and Reinfusion in Surgery and Trauma. Bethesda, MD:
American Association of Blood Banks, 1997:5.
3
American Association of Blood Banks.Guidelines for Blood
Recovery and Reinfusion in Surgery and Trauma. Bethesda, MD:
American Association of Blood Banks, 1997:20.

PROCEDURES FOR USE

under
Suction Assembly and Blood Collection Reservoir
(120-micron Gross Filter or 30-micron Filter)
1. Open the side of the Procedure Set tray that contains the
Suction Assembly and the Blood Collection Reservoir.
for
2. Remove the Suction Assembly and the Reservoir from the
nd
tray and mount the Reservoir into the Reservoir Holder.
3. Prior to use, prepare anticoagulant solution according to
institutional protocol.
4. The anticoagulant solution is prepared by the operator prior to
the start of the case. The solution consists of heparin or
citrate and sterile normal saline (injectable or special product
2
2
. A self-
3
.
Sorin Group Italia