baxter EASYSPRAY User manual

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.
For full prescribing information about Tisseel, contact your local sales representative
Insert 9V battery into the EASYSPRAY
pressure regulator device.
Instructions for Circulating Nurse |EasySpray Pressure Regulator
Check 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
pressure control knob.
6
Turn the on/off switch on the front side
of the EASYSPRAY to the ON (I) position.
5
Connect Spray Set filters to EASYSPRAY
device. Connect the blue filter (pressure
line) to the blue female luer connector and
the clear filter (sensor line) to the male luer
connector.
4
Use suitable connection tube to connect
the EASYSPRAY device to medical air
(ranging 3.5 – 7 bar / 50 – 100 psi).
3
Connect EASYSPRAY device to IV pole
or cart rail using the clamps on the back
of the device.
21
Instructions for Scrub Nurse |Spray Set
Pass the assembled applicator to the
surgeon for spray application. Pass the
end of the connection tube with the
sterile filters to the circulating nurse.
6
Attach the clip (on the end of the sensor
line) by sliding it into the grooves located
on the top of the syringe plunger.
5
Fit the connection tube of the spray set to
the luer-lock connector on the underside of
the spray head.
4
Fasten the pull strap to the double
syringe system to assure the spray head
is tightly secured.
3
Firmly attach the spray head to the
nozzle of the syringes.
2
Prepare TISSEEL Fibrin Sealant according
to the instructions in the package insert.
1
Instructions for Surgeon
Spray from a distance of 10 – 15 cm for
optimum results.
To activate the flow of gas occlude the
opening in the clip center with thumb.
To begin application, gently depress the
syringe plunger.
32
Caution: 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. 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.
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 2.0 bar (28.5 psi) to minimize the potential risk of air or gas embolism, tissue rupture, or air or gas entrapment with
compression.
Confirm (verbally) the actual pressure
with OR personel.
1
EASYSPRAY Quick Reference Guide (for open wound surgery)

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 CO2should 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 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.
• Regulators should be used in line with manufacturer recommendations and the SmPC and Instruction for Use.