DUPLOSPRAY MIS Applicator Snap Lock Attachment Instruction Sheet Aug 2017

ASSEMBLE SNAP LOCK APPLICATOR Push the male syringe set(1)luers all the way into the female luer cones on the applicator.

4

5 Push the snap lock all the way down to securely fasten the applicator to the syringe luers.

(1.1)

6

(1.2)

Match the single blue dot on the syringe’s calibrated side with the blue dot on the applicator. If multiple syringes are required in a procedure, inconsistent orientation of syringes may cause the dualchamber applicator to clog.

7

Connect the clear female luer connector on the tubing set to the male luer gas port on the applicator.

Connect the red male luer connector on the tubing set to the female luer connector on the trocar vent value. Ensure vent valve is fully open.

DISPENSE 1

2

3

Check the gas flow meter on regulator before inserting applicator into trocar. Maximum flow rate = 2.0L/ min; recommended spray distance 3cm (range 2-5cm).

NOTE: If using DUPLOSPRAY 360 Degree, angle the flexible tip at the end of the applicator by grasping and turning with an endoscopic grasper.

Press the foot switch of the DUPLOSPRAY MIS Regulator to start the gas flow prior to applying TISSEEL. NOTE: Spray application precaution: any application of pressurized gas may be associated with a potential risk of air embolism, tissue rupture 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, or the TISSEEL PI.

While activating the foot switch, dispense TISSEEL into the applicator by depressing syringe plungers using VERY SLOW STEADY PRESSURE. To stop spray delivery, release pressure on syringe plungers while maintaining gas flow by holding foot switch down for 3-5 seconds after applying TISSEEL to clear the applicator’s tip.

RELEASE APPLICATOR 1

Press the release button on the back of the snap lock. PUSH HERE TO RELEASE

2 Detach applicator from syringe. Dispose of as biohazard waste.

DUPLOSPRAY MIS Applicator S N A P LO C K AT TAC H M E N T INSTRUCTION SHEET

DUPLOSPRAY MIS and 360 Endoscopic Applicator Product Codes with NEW SNAP LOCK ATTACHMENT DESCRIPTION

EA PER PACK

NEW CODES

0600029

DUPLOSPRAY MIS APPLICATOR WITH SNAP LOCK 30cm

5/PK

0601129

0600030

DUPLOSPRAY MIS APPLICATOR WITH SNAP LOCK 40cm

5/PK

0601130

0600128

SPRAY SET 360 ENDOSCOPIC APPLICATOR WITH SNAP LOCK

5/PK

0611128

EXISTING CODES

INTENDED USE

TISSEEL [Fibrin Sealant]

The DUPLOSPRAY MIS Applicator is intended for the application of TISSEEL [Fibrin Sealant].

NAME OF THE DRUG - TISSEEL [Fibrin Sealant] Two-Component Fibrin Sealant, Deep-Frozen, Vapour Heated (VH) and Solvent Detergent (S/D) treated, TISSEEL VH S/D.

WARNINGS/ PRECAUTIONS

INDICATIONS: TISSEEL is indicated as adjunct to haemostasis during surgical procedures, when control of bleeding by conventional surgical techniques is ineffective or impractical; as a sealant as an adjunct for closure of colostomies; as a sealant and/or adhesive for use in autologous chondrocyte implantation (ACI) or matrix-induced autologous chondrocyte implantation (MACI) procedures; mesh fixation in non-iatrogenic abdominal wall hernia repair, as an alternative to sutures, staples or tacks.

Only qualified personnel should operate this device. Use only with approved DUPLOSPRAY MIS Regulators. Connect DUPLOSPRAY regulator to down-regulated CO2 gas source; maximum input pressure not to exceed 100 psi (7 bar). See regulator IFU for more information. Caution must be used when applying product using pressurized gas. • Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. This event appears 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 sealants using a spray device, be sure to use the flow rate recommended in the Instructions for Use. • To avoid possible gas embolism, do not spray directly into circulatory pathways. Any application of pressurized gas is associated with a potential risk of air embolism, tissue rupture or gas entrapment with compression, which may be life threatening. Be sure to take appropriate measures to address these risks by observing these recommendations: • Do not spray at a distance closer to the surface of tissues than 2 cm (3 cm is recommended) at a maximum flow rate of 2.0 liters per minute (L/min). FLOW RATE

1.0 - 2.0 Liters per minute (L/min)

DISTANCE

2cm

3cm recommended

5cm

• When using pressurized spray devices, changes in blood pressure, pulse, oxygen saturations, and end tidal should be monitored because of the possibility of occurrence of air gas embolism.

CONTRAINDICATIONS: Known hypersensitivity to aprotinin or any other component of TISSEEL. Injection of TISSEEL into tissues is contraindicated. Such use has been associated with inadvertent intravascular injection which may result in life-threatening thromboembolic complications, can lead to intravascular coagulation which may increase likelihood and severity of acute hypersensitivity reactions in susceptible patients. TISSEEL should be applied with caution to minimise any risk of intravascular application, for example in coronary bypass surgery. TISSEEL should only be applied topically. Soft tissue injection of TISSEEL carries the risk of an anaphylactic reaction and/or local tissue damage. PRECAUTIONS: Viral and prion risk due to human plasma derived sealer protein concentrate and thrombin. Products made from human plasma may contain infectious agents which can cause disease. Standard measures are taken to prevent infection but when medicinal products are prepared from human blood or plasma, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. Administration of TISSEEL may result in allergic reactions. For patients with a known allergic diathesis, history of hypersensitivity to medical products or who have previously received aprotinin-containing products (including previous use of TISSEEL) a careful risk-benefit assessment should be carried out prior to administration. Risk of immunisation against proteins such as aprotinin is increased if repeated exposure occurs within six months. TISSEEL contains synthetic aprotinin which is structurally identical to bovine aprotonin so use in patients with allergies to bovine proteins should be carefully evaluated. 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 TISSEEL. These events appear to be related to the use of spray devices at higher than recommended pressures and/or in close proximity to the tissue surface. The risk appears to be higher when Tisseel is sprayed with air, compared to CO2 and therefore cannot be excluded with Tisseel when sprayed in open wound surgery. TISSEEL alone is not indicated for severe or brisk arterial or venous bleeding. TISSEEL should not be used for sealing neuroanastomoses. Do not inject into nasal mucosa. If fibrin sealants are applied in confined bodily spaces, the risk of compressive complications should be taken into account. INTERACTIONS/INCOMPATIBILITIES: There are no known interactions between TISSEEL and other drugs. Efficacy has been demonstrated in fully heparinised patients undergoing

Baxter, Duplospray, Tisseel, Tissucol and Advancing Surgery, Enhancing Life are trademarks of Baxter International Inc., its subsidiaries or affiliates. ANZ/90/17-0008 Created August 2017

Baxter Healthcare 1 Baxter Drive, Old Toongabbie, NSW 2146, Australia T (02) 9848 1111 F (02) 9848 1123 baxterhealthcare.com.au

Baxter Healthcare 33 Vestey Drive, Mt Wellington, Auckland 1060, New Zealand T (09) 575 2400 F (09) 574 2450 baxter.co.nz

cardiopulmonary bypass. Solutions containing alcohol, iodine or heavy metals (e.g disinfectants) should be thoroughly rinsed off wound area before TISSEEL application. Oxidised cellulosecontaining preparations may reduce the efficacy of TISSEEL and should not be used as carrier material. Do not mix TISSEEL with other medicinal products. ADVERSE EFFECTS: Anaphylactic and anaphylactoid reactions may occur in patients who have previously received a fibrinbased sealant, in those with a known hypersensitivity to aprotinin and in those who have previously received aprotinin systemically. Even if the second treatment with TISSEEL was well tolerated, a subsequent administration of TISSEEL or systemic administration of aprotinin may result in severe anaphylactic reactions. Symptoms associated with allergic/anaphylactic reactions include flushing, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnoea, severe hypotension, and anaphylactic shock. In the event of hypersensitivity reactions, administration of TISSEEL should be discontinued, the topical clot removed, and appropriate treatment instituted. In rare cases, these reactions may also occur in patients receiving aprotinin or TISSEEL for the very first time. Common adverse reactions in clinical trial: fibrin degradation products increased, post-procedural pain. Fibrin sealant/haemostatic class reactions: manifestations of hypersensitivity such as application site irritation, chest discomfort, chills, headache lethargy, restlessness, vomiting. DOSAGE AND METHOD OF USE - TISSEEL should only be administered topically. Do not inject. Tisseel must not be applied intravascularly. The required dose depends upon the size of the surface to be covered. To avoid the formation of excess granulation tissue, and to ensure gradual absorption of the solidified fibrin sealant, only a thin layer of TISSEEL should be applied. Application can be repeated, if necessary, but avoid re-application of TISSEEL to a pre-existing polymerized TISSEEL layer. See PI for preparation details. Do not microwave TISSEEL. TISSEEL should only be used when, after thawing, the Sealer Protein Solution has a viscous consistency similar to honey. If the Sealer Protein Solution has the consistency of a gel, it must be assumed to have denatured and should not be used. The protective syringe cap should not be removed until thawing is complete and application tip is ready to be attached. Do not use TISSEEL unless it is completely thawed and warmed (liquid consistency). The solutions must be used within 72 hours after thawing at or below 25 °C. Prior to application, TISSEEL must be warmed to 33-37°C and must not be exposed to >37°C. Application of TISSEEL must be completed within 4 hours after opening the preloaded frozen double chamber syringe. Discard any unused product and/or devices. See full PI for details. Review Product Information before prescribing. Full Product Information is available from Baxter Medical Information on 1300 302 409 or [email protected] TISSEEL, and DUO SET are trademarks of BAXTER AG. BAXTER is a trademark of Baxter International Inc. Date of TGA approval: 09 February 2009. Last revised: August 2017, TAPS 4711MM