Any application of pressurised 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 Fibrin Sealant and ARTISS Solutions for Sealant
b
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.
b 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.
b 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).
b 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.
b Regulators should be used in line with manufacturer recommendations and
the SmPC and Instruction for Use.
For TISSEEL Fibrin Sealant only
b
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). The product should be
sprayed at a distance at least 2cm (recommended range 2-5cm) from the
tissue surface.
For ARTISS Solutions for Sealant only
b
ARTISS is recommended for subcutaneous use only. ARTISS is not
recommended for laparoscopic use.
CAUTION BOX
EASYSPRAY and DUPLOSPRAY MIS Pressure Regulator -
Instructions for correct usage
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