Quick Reference Guide
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EASYSPRAY Pressure Regulator Quick Reference Guide
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Instructions for Circulating Nurse – EASYSPRAY Device
Connect EASYSPRAY device to IV pole or cart rail using the clamps on the back of the device.
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Set wall unit pressure between 3.5 and 7 bar (51-100 psi).
Connect the black tube, located at the side of the EASYSPRAY device, to a propellant gas source. Use medical compressed air or nitrogen only.
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.
Turn the on/off switch on the front side of the EASYSPRAY device to the ON position.
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.
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Spray Set for TISSEEL [Fibrin Sealant]
Prepare TISSEEL [Fibrin Sealant] according to the instructions in the package insert.
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Instructions for Scrub Nurse –
For Topical Use Only
For Tech Support Call 1-877-TISSEEL
For Topical Use Only
Firmly attach the spray head to the nozzle of the syringes.
For Topical Use Only
Fasten the pull strap to the syringe to assure the spray head is tightly secured.
For Topical Use Only
Fit the connection tube of the spray set to the Luer-lock connector on the underside of the spray head.
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For Topical Use Only
Attach the clip (on the end of the sensor line) by sliding it into the grooves located on the top of the syringe plunger.
For Topical Use Only
A spraying distance of 10 –15 cm is recommended. In specific situations where spraying at less than 10 cm is necessary, the gas pressure must be reduced appropriately.
Pass the assembled TISSEEL syringe to the surgeon for spray application. Pass the end of the connection tube with the sterile filters to the circulating nurse.
O2 Do Not connect to an oxygen source.
Instructions for Surgeon
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For Topical Use Only
Do Not use rechargable batteries. TIPS • 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 Topical Use Only
To activate the flow of gas, occlude the opening in the clip center with thumb. To begin application, gently depress the TISSEEL syringe plunger.
Selected Important Risk Information -Air or gas embolism has occurred when using the spray device without fibrin sealant, or fibrin sealant was administered using pressurized gas. This may occur if a spray device is used at higher than recommended pressures and/or in close proximity to the tissue surface. Please see Indications and Important Risk Information and using the spray device without the fibrin sealant on the back. Rx Only: For safe and proper use of these devices, please refer to the appropriate full device Instructions for Use included.
For Tech Support Call 1-877-TISSEEL (1-877-847-7335)
TISSEEL [Fibrin Sealant] Indications Hemostasis:TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. Important Risk Information for TISSEEL For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events, and may increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients. Exercise caution to minimize the risk of intravascular application when using TISSEEL in surgery. Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin. Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained. Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously. Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure. Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site. Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This may occur if a spray device is used at higher than recommended pressures and in close proximity to the tissue surface. When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites. TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL. Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness may negatively interfere with wound healing. The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved. TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Please see accompanying full Prescribing Information.
The information presented here has been taken directly from the TISSEEL [Fibrin Sealant] Prescribing Information, 01/2012, the TISSEEL/ARTISS Spray Set Instructions for Use, 6208400ZA06 and the EASYSPRAY Pressure Regulator Instructions for Use, 6299610EH04. Baxter, Artiss, Easyspray and Tisseel are trademarks of Baxter international Inc. RM0499B 04/2012
O2 Do Not connect to an oxygen source. Do Not use rechargable batteries.
Baxter International Inc. One Baxter Parkway Deerfield, Illinois 60015 www.baxter.com