Do Not connect to an oxygen source.
Do Not use rechargable batteries.
O2
The information presented here has been taken directly from the TISSEEL [Fibrin Sealant] Prescribing Information, 11/2014, the
TISSEEL/ARTISS Spray Set Instructions for Use, and the EASYSPRAY Pressure Regulator Instructions for Use.
Baxter, Artiss, Easyspray and Tisseel are trademarks of Baxter International Inc.
USMP/90/15-0017(1) 9/2015
Baxter International Inc.
One Baxter Parkway
+LLYÄLSK03
www.baxterbiosurgery.com
EASYSPRAY INDICATIONS FOR USE
The EASYSPRAY Pressure Regulator controls and releases pressurized gas provided by a propellant gas source.The
EASYSPRAY Pressure Regulator is to be used only with spray sets specified for use with this pressure regulator.
• CAUTION: Pressurized gas supply must be between 3.5 and 7 bar.
• CAUTION: DO NOT connect to an oxygen source. Failure to follow these instructions can lead to explosion, which
could result in serious injury or death.
• WARNING: Any application of pressurized gas may be associated with a potential risk of air embolism, tissue
rupture or gas entrapment with compression, which may be life threatening. Be sure to take appropriate measures to
address these risks by observing the recommended minimum spraying distance and maximum pressure provided in
the appropriate spray set instructions for use.
• CAUTION: Spraying into enclosed body cavities requires appropriate safety measures to make sure that the above
mentioned risks will be avoided.
• CAUTION: Do not use rechargeable batteries.
Please see full Indications for Use.
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* CO2 is the preferred gas for application, however Medical Air or Nitrogen are acceptable gasses for administration of Tisseel in open surgery.
TISSEEL [Fibrin Sealant] Indications
Hemostasis:TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients
(> 1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture,
ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients
Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and
ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.
Important Risk Information for TISSEEL[Fibrin Sealant]
For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized
tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, can result in life- threat-
ening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in
susceptible patients.To minimize the risk of intravascular application, exercise caution when using TISSEEL in surgery.
Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
Do not use TISSEEL for treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be
washed away in the flow of blood before hemostasis can be attained.
Do not spray TISSEEL where the minimum recommended distance from the applicator tip to the target site cannot be
assured.
Hypersensitivity or allergic/anaphylactoid reactions can occur with the use of TISSEEL. Such reactions may especially
be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been adminis-
tered previously.
Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of
aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.
Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the
application site.
Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This can occur if a spray
device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface.
When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA,
TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.
TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these
substances have been used to clean the wound area, the area must be thoroughly rinsed before the application
of TISSEEL.
Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness can negatively
interfere with wound healing.
The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical
procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA
approved.
TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant
Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Please see accompanying full Prescribing Information.
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