©2012 Terumo BCT, Inc.
Page 2 of 14
PN 306620452
Applications
for Use
The use of the TSCD II device permits sterile connection in a variety of applications.
Refer to FDA’s
Guidance for Industry: Use of Sterile Connecting Devices in Blood
Bank Practices
for recommended practices and procedures for use in the blood
banking industry. Some of the more common uses of the TSCD II device are to:
Add a leukocyte reduction filter
Remove samples from blood product containers for testing
Add a new needle to a blood collection or apheresis processing set
Prepare components. For example, add one or more bags, as specifically
needed, for component separation after collection of whole blood in a single
bag; or add one or more bags when additional components are needed, i.e.
make a triple set out of a double set
Pool blood products
Prepare an aliquot for pediatric use and divided units. For example, attach a
syringe set or a set of bags to prepare aliquots of whole blood, red blood
cells or plasma
Connect additional saline or anticoagulant lines to an apheresis processing
set
Connect a bag of processing or additive solution or reconnect one that was
mistakenly removed
There are many other instances where it is desirable to maintain a closed system at
a connection site rather than to use the traditional “spiking” procedure.
The TSCD II device is not to be used with tubing that is connected to a person.
This device is for use by trained individuals in such settings as blood bank
laboratories and hospitals.
Materials
TSCD II Sterile Tubing Welder, including these standard accessories
included with purchase:
–
Wafer disposal box
–
Air
filter
–
AC
power
cable
–
Fuses
–
Operating
instructions
–
TSCD
wafers
–
TSCD II bag support shelves (2)
–
Feet to support the TSCD II bag support shelves (4)
–
Device
cover
Plastic
hemostats
Additional
TSCD
wafers