CAUTION: US Federal law restricts the sale and use of this device
TV0918
TV1430
Oxygen
79.2g/day
429g/day
CO2
654g/day
3.5 kg / day
H2O
4.4 g / day
2.28 g / day
by or on the order of a physician.
Disclaimer of Warranties
OriGen Biomedical warrants that reasonable care has been used in the manufacture of this
device and that it was free from defects in workmanship or materials at the time of
shipment from OriGen. OriGen's sole obligation shall therefore be to repair or replace any
device which it determines was defective at the time of shipment. Because no product is
completely effective under all circumstances, and because the actual use and handling of
this device is beyond our control, OriGen cannot warrant for a good effect or against a bad
effect in the application and use of this device. The buyer therefore assumes all liability
arising from any cause for damages resulting from use, misuse or resterilization of this
product. OriGen therefore gives no warranty of merchantability or fitness for a particular
purpose. OriGen shall not be liable for incidental or consequential loss, damage or expense
resulting from the use or application of this product. This warranty is in lieu of all other
warranties, whether implied, express, oral or written, and no individual has the authority to
vary the terms of this warranty.
OriGen Biomedical, Inc. European Representative
7000 Burleson Rd, Bldg D Advena Ltd.
Austin, TX, USA 78744 Tower Business Centre
Tel: +1 512 474 7278 2nd Flr, Tower Street,
Fax: +1 512 617 1503 Swatar, BRK 4013 Malta
Email: sales.us@origen.com
www.origen.com
OriGen TissueVault Tissue Freezing Bag
Instructions for Use
Indications
The OriGen TissueVault Tissue Freezing Bags are indicated for
use in freezing cells and tissues. For single use only. Contraindicated
for other uses.
Sterile
Products are sterile, singly packed. Sterilized with Radiation.
WARNING: Re-sterilization may damage the product. Re-use
may cause contamination or viral transmission between tissues.
Product Characteristics
Materials:
The OriGen TissueVault is made of EVO copolymer. This
material is easily sealed and remains flexible in liquid nitrogen.
Contains no phthalates, BPA, or latex.
The TissueVault is supplied as a flat pouch with one end open,
and is designed to freeze solid tissue and bone.
Gas permeable:
The TissueVault bag is gas permeable, but water vapor
transmission rates are very low. Gas transfer rates for O2, H2O and
CO2 under ideal conditions are as follows:
LC44. R05: 2019-01, OriGen Biomedical, Inc. All Rights Reserved
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.
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.
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: Migration of liquid nitrogen (LN) into the bag
during storage may cause the bag to burst during rewarming. 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: It is not known if a virus can penetrate the
bag wall when stored in liquid phase g liquid nitrogen.
Caution:
These instructions should be read by all personnel before using
the device.
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