baxter EASYSPRAY User manual

Reference Guide
Correct Usage
of EASYSPRAY and
DUPLOSPRAY Pressure Regulator
b

EASYSPRAY and DUPLOSPRAY MIS Pressure Regulator -
Instructions for correct usage
EASYSPRAY Pressure Regulator Operation (open surgery)
1Insert 9V battery into the
EASYSPRAY Pressure
Regulator device
4Connect Spray Set filters
to EASYSPRAY device.
Connect the blue filter to the
blue female luer connector
and the clear filter to the
male luer connector
2Connect EASYSPRAY device
to IV pole or cart rail using
the clamps on the back of
the device
5Turn the on/off switch on the
front side of the EASYSPRAY
to the ON (I) position
3Use suitable connection tube
to connect the EASYSPRAY
device to medical air
(ranging 3.5 – 7 bar /
50 – 100 psi)
6Check the gauge on the
EASYSPRAY device for the
appropriate pressure range
of 1.5-2.0 bars
(21.5-28.5 psi). Adjust
pressure setting by turning
the black pressure control
knob
DUPLOSPRAY MIS Pressure Regulator Operation (laparoscopic procedures)
1Position DUPLOSPRAY
System so the foot pedal is
placed next to the surgeon’s
foot at time of application
4While depressing foot pedal,
adjust gas flow rate to
1.0-2.0 liters per minute.
Check gas flow by noting
height of ball in flow gauge
while stepping on foot pedal
2Attach gas supply hose,
located at back of regulator,
to source of medical grade
CO2
5Depress foot pedal to start gas flow prior
to applying TISSEEL Fibrin Sealant. Check
gas flow gauge on regulator before inserting
applicator. If flow level ball does not move when
foot pedal is depressed, the applicator tip is
occluded and should be replaced
3Attach spray set to regulator.
Connect the blue vent line
filter to the blue female luer
and the clear gas line
filter to the male luer on the
regulator

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
bIn 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.
bSpray 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.
bPrior 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).
bBlood pressure, pulse rate, oxygen saturation and end tidal CO2should 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.
bRegulators should be used in line with manufacturer recommendations and
the SmPC and Instruction for Use.
For TISSEEL Fibrin Sealant only
bIn laparoscopic procedures:Use CO2only when using spray application.
When applying the product as a spray using a CO2pressure 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
bARTISS 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

Fibrin Sealant Surgery Spray set to be used Applicator tips to be used Pressure regulator to be used Recommended distance
from target tissue Recommended spray pressure/flow rate
TISSEEL
Open surgery
TISSEEL/ARTISS Spray Set n.a. EASYSPRAY
10-15cm 1.5-2.0 bar (21.5-28.5 psi).
TISSEEL/ARTISS Spray Set 10 Pack n.a. EASYSPRAY
Laparoscopic/ minimally
invasive procedures n.a.
DUPLOSPRAY MIS Applicator
20cm
DUPLOSPRAY MIS Regulator
2-5 cm 1.0-2.0 L/min
(1.2-1.5 bar/ 18-22 psi)
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
ARTISS
Open surgery
TISSEEL/ARTISS Spray Set n.a. EASYSPRAY
10-15cm 1.5-2.0 bar (21.5-28.5 psi)
TISSEEL/ARTISS Spray Set 10 Pack n.a. EASYSPRAY
Laparoscopic/ minimally
invasive procedures n.a n.a n.a n.a n.a
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 and in the table above.

Recommended Pressure and Distance | Overview
Fibrin Sealant Surgery Spray set to be used Applicator tips to be used Pressure regulator to be used Recommended distance
from target tissue Recommended spray pressure/flow rate
TISSEEL
Open surgery
TISSEEL/ARTISS Spray Set n.a. EASYSPRAY
10-15cm 1.5-2.0 bar (21.5-28.5 psi).
TISSEEL/ARTISS Spray Set 10 Pack n.a. EASYSPRAY
Laparoscopic/ minimally
invasive procedures n.a.
DUPLOSPRAY MIS Applicator
20cm
DUPLOSPRAY MIS Regulator
2-5 cm 1.0-2.0 L/min
(1.2-1.5 bar/ 18-22 psi)
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
ARTISS
Open surgery
TISSEEL/ARTISS Spray Set n.a. EASYSPRAY
10-15cm 1.5-2.0 bar (21.5-28.5 psi)
TISSEEL/ARTISS Spray Set 10 Pack n.a. EASYSPRAY
Laparoscopic/ minimally
invasive procedures n.a n.a n.a n.a n.a
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 and in the table above.

Notes

Notes

Baxter Healthcare Ltd
Wallingford Road, Compton
Newbury, RG20 7QW
T:[phone]
F:[phone]
Baxter, Tisseel, Tissucol, Artiss, Duplospray, and Easyspray are trademarks of
Baxter International Inc., its subsidiaries or affiliates
UKI/128/19-0001 JXO\2019
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