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.
Please see the ARTISS SmPC provided together with this material.
Instructions for Circulating Nurse |EasySpray Pressure Regulator
Instructions for Scrub Nurse |Spray Set
Pass the assembled applicator to the sur-
geon 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 ARTISS Solution for Sealants
according to the instructions in the
package insert.
1
Instructions for Surgeon
To activate the flow of gas occlude the
opening in the clip center with thumb.
To begin application, gently depress the
syringe plunger.
3
Spray from a distance of 10 – 15 cm for
optimum results.
2
Confirm (verbally) the actual pressure
with theatre personnel.
1
Insert 9V battery into the EASYSPRAY
pressure regulator device.
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
black 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 to the blue
female luer connector and the clear filter 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
trolley rail using the clamps on the back
of the device.
21
The use of ARTISS Solutions for Sealant is restricted to experienced surgeons who have been trained in the use of ARTISS.
In order to ensure optimal safe use of ARTISS 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.
EASYSPRAY Quick Reference Guide (for open surgery)
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.

EASYSPRAY Quick Reference Guide
For detailed information please contact your local representative.
Baxter, Artiss, and Easyspray are trademarks of Baxter International Inc., its subsidiaries or affiliates.
ROI/MG24/13-0001e September 2013
WARNINGS AND PRECAUTIONS
Caution: Pressurised gas supply must be between 3.5 and 7 bar (50-100 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: Spraying into enclosed body cavities requires appropriate safety measures to make sure that the above mentioned risks will be avoided.
NOTE: Do not use with rechargeable batteries. The use of accessories of other manufacturers is not permitted.
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 ARTISS Solutions for Sealant
• In open-wound: 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.
• ARTISS is recommended for subcutaneous use only. ARTISS is not recommended for laparoscopic use.
CAUTION BOX
When applying ARTISS using a spray device be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer as follows:
Recommended pressure, distance and devices for spray application of ARTISS
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 of subcutaneous tissue 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
When spraying the ARTISS, changes in blood pressure, pulse, oxygen saturation and end tidal CO2should be monitored because of the possibility of occurrence of air or gas embolism.
PRESCRIBING INFORMATION – ARTISS
(Please consult the Summary of Product Characteristics before prescribing)
Name and composition: ARTISS Solutions for Sealant – one prefilled double chamber syringe containing Sealer
Protein Solution (with aprotinin) deep frozen in one chamber and Thrombin Solution (with calcium chloride) deep
frozen in the other chamber. Sealer Protein Solution contains 91mg/ml human fibrinogen (clottable protein) and 3000
KIU/ml aprotinin. Thrombin Solution contains 4 IU/ml human thrombin and 40μmol/ml calcium chloride. Presenta-
tions of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of total volume of product ready for
use. Contains human factor XIII co-purified with human fibrinogen in a range of 0.6 – 5 IU/ml. Indication: Hospital
use only. A tissue glue to adhere / seal subcutaneous tissue in plastic, reconstructive and burn surgery, replacement
or adjunct to sutures or staples. Adjunct to haemostasis on subcutaneous tissue surfaces. Dosage and Route: The
use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. For epilesional
use. Dose individualised and governed by indication, application methods and number of applications. Guide – 1
pack ARTISS 2ml sufficient for an area at least 10 cm2. Avoid excess granulation by applying only a thin layer. Sur-
face of the wound should be as dry as possible. Side effects: See summary of product characteristics for detail.
Risk of anaphylactic reaction. Intravascular injection may lead to life-threatening thromboembolic events. Hypersen-
sitivity or allergic reactions. Pruritus, skin graft failure Precautions: Caution applying ARTISS using pressurised gas,
not to be used with Easy Spray / Spray Set system in enclosed body areas - risk of air or gas embolism, tissue rup-
ture or gas entrapment. Use spray device pressure within manufacturers recommended range, not exceeding 2.0
bars. Do not spray closer than 10-15 cm from tissue surface. Monitor blood pressure, pulse, oxygen saturation, end
tidal CO2for possibility of occurrence of air or gas embolism. Not indicated for use where a fast clotting sealant is
required, especially in cardiovascular surgery. Not for use in neurosurgery or gastrointestinal or vascular anastomo-
ses. Excessive clot thickness may interfere with efficacy and wound healing. Care to prevent adhesion at undesired
sites. Signs of hypersensitivity include hives, urticaria, tightness of chest, wheezing, hypotension, anaphylaxis. Risk
of anaphylaxis increased if previous exposure to aprotinin. In event of hypersensitivity or anaphylaxis discontinue
use and remove polymerised product from surgical site. Oxycellulose containing preparations may reduce ARTISS
efficacy. Infectious diseases due to transmission of infective agents cannot be totally excluded. Use of ARTISS
and batch number should be recorded in patients’ notes. Carefully evaluate in patients with allergies to bovine
proteins. Contra-indications: Not indicated to replace sutures intended to close surgical wound. Not for treatment
of massive and brisk arterial or venous bleeding. Not for intravascular use. Hypersensitivity to active substances
or excipients. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. Overdose: No cases of
overdose have been reported. Legal Category: POM Marketing Authorisation Number and Holder: ARTISS – PA
167/131/001, Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk. IP24 3SE. Date of Preparation: March 2013
Any adverse event relating to Baxter products should be reported to Baxter Healthcare directly by calling
01-206-5500 and asking for the Quality Department.
Baxter Healthcare encourages healthcare professionals to continue to be vigilant and to report suspected
adverse reactions with ARTISS to the Irish Medicines Board (online at www.imb.ie, telephone [phone]
or using the yellow card system).
Baxter Healthcare Ltd
Unit 7 Deansgrange Business Park
Blackrock
Co. Dublin
Tel: [phone]
Fax: [phone]
www.baxterhealthcare.ie