baxter EASYSPRAY User manual

EASYSPRAY Quick Reference Guide (for open wound surgery)
Instructions for Circulating Nurse | EASYSPRAY Pressure Regulator
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Instructions for Scrub Nurse | Spray Set
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Instructions for Surgeon
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The use of TISSEEL Fibrin Sealant is restricted to experienced surgeons who have been trained in the use of TISSEEL.
In order to ensure optimal safe use of TISSEEL by spray application, apply a minimum spray distance of 10 cm and
a maximum spray pressure of 2 bar to minimise the potential risk of air or gas embolism, tissue rupture, or air or gas
entrapment with compression.
The EASYSPRAY device will continue to emit gas for a brief period after the thumb is removed from the clip/plunger.
This delay helps to avoid clogging of the spray head.
Please see the TISSEEL SmPC provided together with this material.
Caution: 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. Be sure to take appropriate measures to address
these risks by observing the recommended minimum spraying distance and the maximum pressure provided in the
appropriate spray set instructions for use.
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CAUTION BOX
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
U Ê«iÜÕ`ÊÃÕÀ}iÀÞ\ÊÜiÊ>««Þ}ÊëÀ>Þ>LiÊvLÀÊÃÕÌÃÊvÀÊÃi>>ÌÊÕÃ}Ê>Ê«ÀiÃÃÕÀiÊÀi}Õ>ÌÀÊ`iÛVi]ÊÌiÊ>ÝÕÊ«ÀiÃÃÕÀiÊÃÕ`ÊLi
2.0 bar (28.5 psi). The product should be sprayed at a distance at least 10 cm from the tissue surface.
U -«À>ÞÊ>««V>ÌÊÃÕ`ÊÞÊLiÊÕÃi`ÊvÊÌÊÃÊ«ÃÃLiÊÌÊ>VVÕÀ>ÌiÞÊÕ`}iÊÌiÊëÀ>ÞÊ`ÃÌ>ViÊ>ÃÊÀiVi`i`ÊLÞÊÌiÊ>Õv>VÌÕÀiÀ°
Do not spray closer than the recommended distances.
U *ÀÀÊÌÊ>««Þ}ÊëÀ>Þ>LiÊvLÀÊÃÕÌÃÊvÀÊÃi>>Ì]ÊÌiÊÃÕÀv>ViÊ>Ài>ÊvÊÌiÊÜÕ`ÊÃÕ`ÊÞÊLiÊ`Ài`ÊÕÃ}ÊÃÌ>`>À`ÊÌiVµÕiÃ
(eg, intermittentapplication of compresses, swabs, use of suction devices).
U `Ê«ÀiÃÃÕÀi]Ê«ÕÃiÊÀ>Ìi]ÊÝÞ}iÊÃ>ÌÕÀ>ÌÊ>`Êi`ÊÌ`>Ê"2should 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.
U ,i}Õ>ÌÀÃÊÃÕ`ÊLiÊÕÃi`ÊÊiÊÜÌÊ>Õv>VÌÕÀiÀÊÀiVi`>ÌÃÊ>`ÊÌiÊ-*Ê>`ÊÃÌÀÕVÌÊvÀÊ1Ãi°
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
TISSEEL/TISSUCOL Spray Set n.a. EASYSPRAY
ÊÀ`iÀÊÌÊiÃÕÀiÊ«Ì>ÊÃ>viÊÕÃiÊvÊ/--ÊLÞÊëÀ>ÞÊ>««V>ÌÊÌiÊvÜ}ÊÀiVi`>ÌÃÊÃÕ`ÊLiÊvÜi`\
When spraying the TISSEEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2should be monitored because of the possibility of occurrence of air
or gas embolism.
WARNINGS AND PRECAUTIONS
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>ÕÌ\Ê"Ê "/ÊViVÌÊÌÊ>ÊÝÞ}iÊÃÕÀVi°Ê>ÕÀiÊÌÊvÜÊÌiÃiÊÃÌÀÕVÌÃÊV>Êi>`ÊÌÊiÝ«Ã]ÊÜVÊVÕ`ÊÀiÃÕÌÊÊÃiÀÕÃÊÕÀÞÊÀÊ`i>Ì°
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.
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devices to make sure that the risks mentioned in this reference guide will be avoided
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EASYSPRAY Quick Reference Guide
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