Baxter Belgium SPRL
bd d’Angleterre 2-4
1420 Braine l’Alleud
EASYSPRAY Quick Reference Guide
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 Easyspray are trademarks of Baxter International Inc., its subsidiaries or affiliates..
BEMP/90/15-0002 date of creation/review: may 2015
CAUTION BOX
WARNINGS AND PRECAUTIONS
Caution: Pressurized gas supply must be between 3.5 and 7 bar (51-100 psi).
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.
Prior to operation make sure that the pressure range of the device is adjusted to the range specified in the appropriate spray set instructions for use.
Caution: Spray application requires appropriate safety measures as described in the pertinent Summary of Product Characteristics and Instructions for Use of the spray devices to make sure
that the risks mentioned in this reference guide will be avoided
NOTE: Do not use with rechargeable batteries. The use of accessories of other manufacturers is not permitted.
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
Open wound
TISSEEL / ARTISS Spray Set n.a. EASYSPRAY
10-15 cm 1.5-2.0 bar (21.5-28.5 psi).
TISSEEL / ARTISS Spray Set 10 pack n.a. EASYSPRAY
DUPLOJECT Spray Set n.a. TISSOMAT
TISSEEL/TISSUCOL Spray Set n.a. EASYSPRAY
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
• In open-wound surgery: when applying sprayable fibrin solutions for sealant using a pressure regulator device, the maximum pressure should be 2.0 bar (28.5 psi).
The product should be sprayed at a distance at least 10 cm from the tissue surface.
• 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.
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