SORIN GROUP BRAT2 Manual Del Usuario página 3

for cell washing). The ratio of heparin to saline will depend
upon hospital protocol. For most cases, a suggested ratio is
30,000 units of heparin in one liter of saline. Citrate
anticoagulation may be achieved by using premixed
Anticoagulant Citrate Dextrose Formula A (ACD-A) or by
preparing a 3 to 4% Trisodium Citrate solution.
Prior to collecting any blood, approximately 200 ml of the
anticoagulant solution should be allowed to accumulate in the
reservoir.
Once collection begins, the operator should continually be
aware of the rate at which blood is being collected and adjust
the flow rate of the anticoagulant solution accordingly. If
heparin anticoagulant has been prepared as suggested
(30,000 units of heparin per liter saline), the flow rate should
be adjusted to mix one part anticoagulant with seven parts of
collected fluid (1:7 ratio).
It is recommended to start with a minimum rate of one drop
per second and adjusting accordingly. If citrate anticoagulant
is used, the flow rate should be adjusted to assure a 1:5-1:10
ratio of anticoagulant to blood.
Use aseptic technique for the following steps:
(Refer to Figure 1.)
5. Remove the cap from the Reservoir Outlet Port (D) and
attach the BRAT Reservoir Outlet Clamp to the Reservoir
Outlet Port (D). Close the slide clamp on the BRAT Reservoir
outlet clamp.
6. 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 the same
proportion. Premixed ACD-A or CPD solutions in bags or
bottles can be used instead of the heparin solution.
7. Remove the Suction Assembly from its package, remove the
outer wrap, and pass the inner sterile wrapped assembly to
the sterile field.
8. At the sterile field, unwrap the Suction Assembly, remove the
red protective cover on the Suction Assembly, and attach the
connector to the suction tip. Pass the other end of the BRAT
Suction Assembly from the sterile field.
9. Remove the remaining protective cover from the large lumen
tube of the Suction Assembly. From the Reservoir, remove
one of the caps from a blood inlet port (C) and attach the
large lumen end.
10. Ensure all unused ports are tightly sealed.
11. From the Reservoir, remove the vent cap from the perimeter
1/4" vacuum/vent port (A). If using vacuum, connect a sterile
vacuum supply tube to the port.
12. Clamp the solution line. 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.
13. Prior to use, prime the tubing and reservoir with sufficient
solution to wet the blood contact surfaces (approximately 200
ml). Assure suction is on during the priming operation.
14. 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 with 5 to 10 parts
blood. A rate of 2 drops every 3 seconds (20 drops/ml) is
sufficient to anticoagulate an end blood product in the
reservoir of approximately one liter per hour.
NOTE: The flow of anticoagulant into the reservoir is manually
controlled by the roller clamp on the anticoagulant line. This flow
must be adjusted to the rate of blood collection from the surgical
field. If the rate of collection varies without adjusting the flow of
anticoagulant, the ratio of anticoagulant to blood can be too low or
too high. The blood in the reservoir may clot if there is too little
anticoagulant.
Sorin Group Italia.
BRAT2 Bowl Processing Set
(Refer to Figure 2.)
1. Open the side of the Procedure Set tray that contains the
BRAT2 Bowl Processing Set. Hang the primary reinfusion
bag from the upper extension arm on the BRAT2 IV pole. Do
not close any of the clamps on the ports. Remove the
remainder of the set from the tray.
2. Hang the waste bag on the three support pins located on the
right side of the BRAT2 console. Do not close the slide clamp
on the inlet tube. Close the drain valve on the bottom of the
waste bag.
3. Open the lid and swing the centrifuge arm to the open
position. To load the centrifuge bowl onto the turntable,
engage the pins on the turntable in the slots on the bowl,
push down and rotate the bowl clockwise, and then release
the bowl so that the pins hold the bowl in place. Confirm that
the bowl is in place and cannot be away from the turntable
without deliberately disengaging the pins.
4. Close the centrifuge arm by pulling it forward. Gently spin the
bowl to ensure that the centrifuge table turns freely.
5. Route the lower port (outlet port) tubing out the notch in the
right side of the centrifuge, leaving a small amount of slack
within the centrifuge. Press the tubing firmly into the notch.
6. Using aseptic technique, connect the waste tube connector
from the outlet port tubing to the waste bag inlet port.
7. Open the valve cover. Remove the protective cover from the
pump valve cartridge. Place the pump valve cartridge down
with the pump loop oriented over the process pump. Ensure
that the color-coded tubings are positioned over the valves
and are not tangled. The loop will later load automatically
when the "load" cycle begins (if the process cover is closed).
8. Press down firmly on the cartridge to ensure that the tubing is
seated properly in the process fluid detector. Close the valve
cover and lid.
9. Using aseptic technique, connect the adapter end of the red-
striped tubing to the Reservoir Outlet Clamp.
10. Open the slide clamp on the Reservoir Outlet Clamp.
11. Close the slide clamp of one of the yellow wash Y-lines.
Using aseptic technique, spike the primary wash Y-line into a
bag of wash solution. Using aseptic technique, spike the
second wash Y-line into a bag of wash solution.
12. Using aseptic technique, remove the breather cap from the
female connector on the primary reinfusion bag. Do not open
the pull tab on the white tamper proof closure. Remove the
blue breather cap from the blue striped line and twist connect
the male connector to the female connector on the reinfusion
bag.
After you have finished connecting all tubing, inspect it
to make sure that there are no kinks in the lines.
RETURN OF USED PRODUCT
Should the user be dissatisfied with anything related to the quality
of the product, the product distributor or the authorized local
SORIN GROUP ITALIA representative should be notified.
All parameters considered critical by the user must be reported
with particular care and urgency. The following is the minimum
information that should be provided:
•
Detailed description of the event and, if pertinent, the
conditions of the patient;
•
Identification of the product involved;
•
Lot number of the product involved;
•
Availability of the product involved;
•
All the indications the user considers useful in order to
understand the origin of the elements of dissatisfaction.
SORIN GROUP ITALIA reserves the right to authorize, if
necessary, recall of the product involved in the notification for
assessment. If the product to be returned is contaminated, it must
be treated, packed and handled in conformity with the provisions of
the legislation in force in the country where the product was used.
3
NOTE
English