SORIN GROUP BRAT2 Manuel D'utilisation page 2

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.
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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
Sorin Group Italia blood collection reservoir. Turn the
Quick-Lock Connector to secure the line to the inlet.
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
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.
REFERENCE ARTICLES
"Minimizing Blood Transfusions During Abdominal Aortic
Surgery: Recent Advances in Rapid Autotransfusion," Hallett
J.W., et al, Journal of Vascular Surgery, 5(4): 601, 1987.
"Panel IV: Dosage Regimens for Citrate Anticoagulants,"
Hester, J.P., et al, Journal of Clinical Apheresis, 1: 149-157,
1983.
"Evaluation of a New Blood Autotransfusion Device,"
Toomasian, J.M. et al,
Cardiovascular Surgery, 92: 936-943, 1986.
SPECIFICATIONS
Dual Lumen Tubing
Large 9.5mm O.D.
Small 4.3mm O.D.
Roller Clamp Control flow rate of 4.3mm O.D.
tube
Aspiration Open end 6.6mm
Connector
Sorin Group Italia
Journal of Thoracic and
6.4mm I.D.
3.0mm I.D.
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
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.
It is the responsibility of the health care institution to
adequately prepare and identify the product for
return shipment. Do not return products that have
been exposed to blood borne infectious diseases.
ONLY for US customers
If for any reason the product must be returned to the
manufacturer, a returned good authorisation (RGA) number
is required from Sorin Group USA, Inc. prior to shipping
If the product has been in contact with blood or blood fluids,
it must be thoroughly cleaned and disinfected before
packing. It should be shipped in either the original carton or
an equivalent carton to prevent damage during shipment,
and it should be properly labelled with an RGA number and
an indication of the biohazardous nature of the content in the
shipment.
It is the responsibility of the health care institution to
adequately prepare and identify the product for
return shipment. Do not return products that have
been exposed to blood borne infectious diseases.
The shipping address for returned goods in the US is:
SORIN GROUP USA, Inc.
Returned CV Products
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031
LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of
the Purchaser pursuant to applicable law.
SORIN GROUP ITALIA warrants that all reasonable care
has been taken in the manufacture of this medical device, as
required by the nature of the device and the use for which
the device is intended.
SORIN GROUP ITALIA warrants that the medical device is
capable of functioning as indicated in the current instructions
for use when used in accordance with them by a qualified
user and before any expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the
user will use the device correctly, nor that the incorrect
diagnosis or therapy and/or that the particular physical and
biological haematological characteristics of an individual
patient, do not affect the performance and effectiveness of
the device with damaging consequences for the patient,
even though the specified instructions for use have been
respected.
2
the product to be returned
CAUTION
CAUTION
is
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