Cryogenic storage:
The Origen TissueVault may be used in any freezing environment
down to -196°C (-322°F). See cautions for direct liquid nitrogen
storage under 'Freezing', below.
Method of Use
1. Examine the packaging to make certain the packaging is
undamaged and unopened.
2. For use on a sterile field, aseptically open the package and drop
the TissueVault on the sterile field or pick it out of the pouch using
aseptic technique.
3. Transfer the tissue(s) into the bag.
4. Heat seal the open end using an impulse or RF sealer. EVO is very
easy to seal, and requires only a low temperature setting on the
sealer. A seal temperature of only 200°F (93°C) is required to seal
the material. The resulting seal should be clear, allowing for easy
inspection of the seal. Also, test the seal by attempting to squeeze
residual air from the bag. If you can, re-seal.
5. The outside of the TissueVault bag may be wiped with alcohol if
desired.
Freezing
1. The TissueVault bag will withstand freezing temperatures down to
liquid nitrogen, -196°C (-321°F).
2. Make certain the outside of the container is dry before freezing in
a cassette. Frost may cause the bag to adhere to the cassette.
3. Freeze the specimen per your institutional protocol.
CAUTION: Freezing and solidification of the contents makes
the TissueVault bag more susceptible to damage by impact. It
is strongly suggested that the bag be placed in a rigid freezing
cassette for storage. Handle carefully when frozen.
CAUTION: It is not known if a virus can penetrate the
bag wall when stored in liquid phase g liquid nitrogen.
Thawing
1. Remove the bag from the cassette prior to thawing and inspect it
for breaks or leaks. If the bag does not easily release from the
cassette, warm the cassette to release the bag.
CAUTION: Migration of liquid nitrogen (LN) into the bag
during storage may cause the bag to burst during re-
warming. During re-warming, LN will gasify much quicker
than it can escape through the bag walls. Monitor the
TissueVault carefully for swelling during re-warming.
2. Many institutions thaw the bag in a 37 to 40°C water bath with
gentle agitation. Observe the container carefully during thawing.
If the bag begins to swell, it may indicate that liquid nitrogen has
seeped into the bag during storage. If this occurs, puncture the
O-wrap to vent pressure.
3. Some cryoprotectants can be toxic to cells at room temperature.
Follow your Institutional protocol and begin tissue recovery as
soon as possible after thawing
Precautions
1. Use caution when handling the bag to prevent breakage. When
the bag contents are frozen, it is much easier to damage the bag
through impact.
2. Use caution with solvents that come in contact with the bag.
While EVO is resistant to most solvents, test on a sample bag
before using on clinical products.
3. Wash out cryoprotectants before patient administration.
Contraindications
There are no known contraindications for the use of the bag
when used as directed.
Caution:
These instructions should be read by all personnel before using
the device.
