DUPLOSPRAY Quick Reference Guide
Connect to regulated CO
2
gas source only; maximum input pressure not to exceed 100 psi ± 5 (6.89 bar ± .35). To avoid possible air or gas embolism, do not directly
spray into circulatory pathways.
Caution: Any application of pressurized gas may be associated with a potential risk of air or gas embolus, tissue rupture or air 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 of 2 cm (optimal
working distance 3 cm) and the maximal flow rate of 2.0 standard liters per minute.
For detailed information please contact your local representative
In some countries TISSEEL Fibrin Sealant is licensed under the trademark of TISSUCOL Fibrin Sealant.
Baxter, Tisseel, Tissucol, and Duplospray are trademarks of Baxter International Inc., its subsidiaries or affiliates.
BEMP/90/15-0003 date of creation/review: may 2015
Baxter Belgium SPRL
bd d’Angleterre, 2-4
1420 Braine l’Alleud
In order to ensure optimal safe use of TISSEEL by spray application the following recommendations should be followed:
Recommended pressure, distance and devices for spray application of TISSEEL
Surgery Spray set to be used Applicator tips to be used Pressure regulator to be used
Recommended distance
from target tissue
Recommended spray
pressure / gas ow rate
Laparoscopic/ minimally
invasive procedures
n.a.
DUPLOSPRAY MIS Applicator
20cm
DUPLOSPRAY MIS Regulator
2 – 5 cm
1.2-1.5 bar (18-22psi) /
1.0-2.0 L/min
DUPLOSPRAY MIS Regulator NIST B11
DUPLOSPRAY MIS Applicator
30cm
DUPLOSPRAY MIS Regulator
DUPLOSPRAY MIS Regulator NIST B11
DUPLOSPRAY MIS Applicator
40cm
DUPLOSPRAY MIS Regulator
DUPLOSPRAY MIS Regulator NIST B11
Replaceable tip
DUPLOSPRAY MIS Regulator
DUPLOSPRAY MIS Regulator NIST B11
When spraying the TISSEEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO
2
should be monitored because of the possibility of occurrence of air or gas embolism.
Any application of pressurized gas may be associated with a potential risk of air or gas embolism, tissue rupture or air or gas entrapment with
compression, which may be life threatening if the product is sprayed incorrectly
Precautions
For TISSEEL/TISSUCOL Fibrin Sealant
• Spray application should only be used if it is possible to accurately judge the spray distance as recommended by the manufacturer. Do not spray closer than the
recommended distances.
• Prior to applying sprayable fibrin solutions for sealant, the surface area of the wound should only be dried using standard techniques (eg, intermittent application of
compresses, swabs, use of suction devices).
• Blood pressure, pulse rate, oxygen saturation and end tidal CO
2
should be monitored closely when spraying fibrin solutions for sealant using a pressure regulator
device, because of the possibility of occurrence of air or gas embolism.
• Regulators should be used in line with manufacturer recommendations and the SmPC and Instruction for Use.
• In laparoscopic procedures: Use CO
2
only when using spray application. When applying the product as a spray using a CO
2
pressure regulator device, the maximum
pressure should be 1.5 bar (22 psi/maximum gas flow rate 2.0 liters per minute). The product should be sprayed at a distance at least 2 cm (recommended range
2-5 cm) from the tissue surface.
CAUTION BOX
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