baxter DUPLOSPRAY User manual

DUPLOSPRAY Quick Reference Guide (laparoscopic procedures)
Position DUPLOSPRAY System so the foot
pedal is placed next to the surgeon’s foot
at time of application.
Instructions for Circulating Nurse |DUPLOSPRAY MIS Regulator
Attach gas supply hose, located at back of
regulator, to source of medical grade CO2.
21
Instructions for Scrub Nurse |DUPLOSPRAY MIS Applicator
Attach patient vent line (red luer connector)
to available female luer on trocar vent valve.
Ensure vent valve is fully open.
6
Pass assembled double syringe and spray
applicator to surgeon for spray application.
5
Attach gas supply line (clear luer connector)
to sterile applicator. Turn white locking
collar to secure connection.
4
Fasten the pull strap to the double
syringe holder to assure the spray
applicator is tightly secured.
3
Firmly attach the applicator to the
nozzles of the double syringe.
2
Thread sterile replaceable tip onto
applicator using tip alignment tool.
1
Instructions for Surgeon
While activating foot pedal dispense
TISSEEL Fibrin Sealant through applicator
tip by depressing double syringe plungers
using very slow, steady pressure. To stop
spray delivery release pressure on plung-
ers while maintaining gas flow by hold-
ing down foot pedal for an additional
3-5 seconds to clear applicator tip.
3
TIPS
• The patient vent line attached to the trocar cannula vent valve will only vent gas out when foot pedal is depressed.
After connection to trocar cannula, ensure vent valve is fully open on trocar cannula prior to spray application.
• If tip becomes occluded during use, remove plugged tip by unscrewing it counterclockwise. Using a sterile cloth,
wipe any clotted material off exposed tube ends. Screw on new tip and tighten with finger pressure.
• The twin-tube assembly can be easily separated as necessary to allow freedom of movement.
Please see the TISSEEL SmPC provided together with this material.
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 2 cm and a maximum spray
pressure of 1.5 bar to minimise the potential risk of air or gas embolism, tissue rupture, or air or gas entrapment with compression.
While depressing foot pedal, adjust gas
flow rate to 1.0-2.0 litres per minute.
Check gas flow by noting height of ball in
flow gauge while stepping on foot pedal.
4
Attach 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.
3
Depress 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.
2
Confirm actual flow of max 2 litres/min
with theatre personnel.
1

DUPLOSPRAY Quick Reference Guide
Connect to regulated CO2gas source only; maximum input pressure not to exceed 100 psi. To avoid possible air or gas embolism, do not directly spray into circulatory
pathways.
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 of 2cm (optimal
working distance 3cm) and the maximal flow rate of 2.0 standard litres per minute.
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 Duplospray are trademarks of Baxter International Inc., its subsidiaries or affiliates..
UK/MG24/13-0003f September 2013
Baxter Healthcare Ltd
Wallingford Road, Compton
Newbury, RG20 7QW
Surecall Tel: [phone]
Surecall Fax: [phone]
Email: [e-mail]
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
Laparoscopic/ minimally
invasive procedures n.a.
DUPLOSPRAY MIS Applicator
20cm
DUPLOSPRAY MIS Regulator
2 – 5 cm 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
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 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
• 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.
• In 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.
CAUTION BOX
PRESCRIBING INFORMATION - TISSEEL
Lyo Two-Component Fibrin Sealant
Ready to use Solutions for Sealant
(Please consult the Summary of Product Characteristics before prescribing)
Name and composition: TISSEEL Lyo - powders and solvents for fibrin sealant. 1) Sealer protein concentrate;
after reconstitution 1 ml contains 96-125 mg total protein of which 72-110 mg is fibrinogen; 2) Aprotinin Solution,
3000 KIU per ml; 3) Thrombin Powder, 1 ml contains 500 IU of Thrombin in 45-55 mg total protein; 4) Calcium
chloride solution, 40µmol per ml. TISSEEL Ready to use – 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 500 IU/ml human thrombin and 40µmol per ml calcium
chloride. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of sealant.
Indications: Supportive treatment where standard surgical techniques are insufficient, for improvement of
haemostasis, as a tissue glue to promote adhesion, sealing or as suture support, in gastrointestinal anastomoses,
in neurosurgery where contact with cerebrospinal fluid or dura mater may occur and for mesh fixation in hernia
repair, as an alternative or adjunct to sutures or staples. Dosage and Route: The use of TISSEEL is restricted
to experienced surgeons who have been trained in the use of TISSEEL. A thin layer is applied to the tissue
surface where required. Dose depends on the indication, application method and number of applications. As a
guideline for the gluing of surfaces, 1 pack of TISSEEL 2 ml (i.e. 1 ml Sealer Protein Solution plus 1 ml Thrombin
Solution) will be sufficient for an area of at least 10 cm2. Apply topically – tissue surface should be as dry as
possible before application. Application can be repeated if necessary. Apply by drops or spray as needed
depending on indication. Side effects: See Summary of Product Characteristics for detail. Hypersensitivity /
anaphylactic / anaphylactoid reactions may occur, especially in patients who have previously received aprotinin.
Early symptoms of allergic reactions include flushing, urticaria, pruritus, nausea, hypotension, tachycardia
or bradycardia, bronchospasm, tightness in chest and dsypnoea. Do not inject – risk of thromboembolic
complications. Precautions: Apply with care in coronary artery bypass surgery due to increased risk of
inadvertent intravascular application. TISSEEL and/or Thrombin Solution should only be applied topically.
When spraying 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. Air or gas embolism, tissue rupture,
or gas entrapment with compression, which may be life-threatening, have occurred with the use of spray
devices employing a pressure regulator to administer fibrin sealant. These events appear to be related to the
use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.
When applying by spray, follow the instructions provided with the spray device, with particular reference to gas
pressure and distance from the tissue surface. Use with caution in patients with prior exposure to aprotinin.
Caution in patients with bovine protein allergies. Infectious diseases due to the transmission of infective agents
cannot be totally excluded. Use of Tisseel and batch number should be recorded in patient’s notes. Excessive
clot thickness may negatively interfere with product efficacy and the healing process. Contraindications: Do
not apply intravascularly. Hypersensitivity to active substances or other components. Not for the treatment of
active or spurting arterial or venous bleeding. Interactions: Avoid solutions containing alcohol, iodine and heavy
metals. Overdose: Not reported. Legal category: POM Basic NHS price: TISSEEL Lyo 2 ml kit - £83.46; 4 ml
kit - £166.92; 10 ml kit - £379.85. TISSEEL Ready to use 2ml - £97.50; 4ml - £195; 10ml - £443.75. Marketing
Authorisation Number and Holder: TISSEEL Lyo - PL 00116/0321. TISSEEL Ready to use - PL 00116/0627
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE Date of preparation: March 2013
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.
uk/yellowcard.Any adverse events relating to Baxter products can also be reported direct to Baxter
Pharmacovigilance on 01635 206360, or by email to [email protected]