Quick Reference Guide
2 Pages
![1 1 1 Connect EASYSPRAY device to IV pole or cart rail using the clamps on the back of the device. 3 Connect the adapter attached to the black tubing, located at the side of the EASYSPRAY device, to an appropriate gas source. Pressurized gas supply must be set between 3.5 and 7 bar (51-100 psi). A spraying distance of 10 –15 cm is recommended. Note that the spraying distance should not be less than 10 cm (3.9”) and the maximum pressure should not exceed 2 bars (29.5psi). 2 For Topical Use Only Firmly attach the spray head to the nozzle of the syringes by aligning the blue dot on the spray head to the blue dot on the syringes. To activate the flow of gas, occlude the opening in the clip center with thumb. To begin application, gently depress the TISSEEL syringe plunger. Instructions for Surgeon Prepare TISSEEL [Fibrin Sealant] according to the instructions in the package insert. For Topical Use Only 2 3 Fasten the pull strap to the double syringe system to assure the spray head is tightly secured. For Topical Use Only Instructions for Scrub Nurse | Spray Set for TISSEEL [Fibrin Sealant] Insert 9V battery into the EASYSPRAY pressure regulator device. 2 Instructions for Circulating Nurse | EASYSPRAY Device 4 4 5 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 Turn the on/off switch on the front side of the EASYSPRAY device to the ON position. The low-battery indicator light will only illuminate when the battery is weak and when the gas flow is activated. If the battery is completely dead, the lowbattery indicator will not illuminate. 6 6 Pass the end of the connection tube with the sterile filters to the circulating nurse. Pass the assembled TISSEEL syringe to the surgeon for spray application. For Topical Use Only Check the gauge on the EASYSPRAY device for the appropriate pressure range of 1.5-2.0 bars (21.8-29 psi). Adjust pressure setting by turning the black pressure control knob. For Tech Support Call 1-888-229-0001,option 4 Do Not connect to an oxygen source. Do Not use rechargable batteries. Rx Only: For safe and proper use of these devices, please refer to the appropriate full device Instructions for Use included. Please see Indications and Detailed Important Risk Information for TISSEEL [Fibrin Sealant] on the reverse side. Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface. Selected Important Risk Information 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. TIPS Fit the connection tube of the spray set to the Luer-lock connector on the underside of the spray head. For Topical Use 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. 5 EASYSPRAY PRESSURE REGULATOR QUICK REFERENCE GUIDE](https://images.bioclinicalservices.com.au/a7Qo8RZR6Jugwsa4mPBa8JoP/320w/Baxter%20-%20EASYSPRAY%20Pressure%20Regulator%20Quick%20Reference%20Guide%20Sept%202015%20-%202015-09.png)
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Page 1
1
1
1
Connect EASYSPRAY device to IV pole or cart rail using the clamps on the back of the device.
3
Connect the adapter attached to the black tubing, located at the side of the EASYSPRAY device, to an appropriate gas source. Pressurized gas supply must be set between 3.5 and 7 bar (51-100 psi).
A spraying distance of 10 –15 cm is recommended. Note that the spraying distance should not be less than 10 cm (3.9”) and the maximum pressure should not exceed 2 bars (29.5psi).
2
For Topical Use Only
Firmly attach the spray head to the nozzle of the syringes by aligning the blue dot on the spray head to the blue dot on the syringes.
To activate the flow of gas, occlude the opening in the clip center with thumb. To begin application, gently depress the TISSEEL syringe plunger.
Instructions for Surgeon
Prepare TISSEEL [Fibrin Sealant] according to the instructions in the package insert.
For Topical Use Only
2
3
Fasten the pull strap to the double syringe system to assure the spray head is tightly secured.
For Topical Use Only
Instructions for Scrub Nurse | Spray Set for TISSEEL [Fibrin Sealant]
Insert 9V battery into the EASYSPRAY pressure regulator device.
2
Instructions for Circulating Nurse | EASYSPRAY Device
4
4
5
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
Turn the on/off switch on the front side of the EASYSPRAY device to the ON position. The low-battery indicator light will only illuminate when the battery is weak and when the gas flow is activated. If the battery is completely dead, the lowbattery indicator will not illuminate.
6
6
Pass the end of the connection tube with the sterile filters to the circulating nurse.
Pass the assembled TISSEEL syringe to the surgeon for spray application.
For Topical Use Only
Check the gauge on the EASYSPRAY device for the appropriate pressure range of 1.5-2.0 bars (21.8-29 psi). Adjust pressure setting by turning the black pressure control knob.
For Tech Support Call 1-888-229-0001,option 4
Do Not connect to an oxygen source. Do Not use rechargable batteries.
Rx Only: For safe and proper use of these devices, please refer to the appropriate full device Instructions for Use included.
Please see Indications and Detailed Important Risk Information for TISSEEL [Fibrin Sealant] on the reverse side.
Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface.
Selected Important Risk Information
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.
TIPS
Fit the connection tube of the spray set to the Luer-lock connector on the underside of the spray head.
For Topical Use 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.
5
EASYSPRAY PRESSURE REGULATOR QUICK REFERENCE GUIDE
USMP/90/15-0017(1) 9/2015
Baxter, Artiss, Easyspray and Tisseel are trademarks of Baxter International Inc.
The information presented here has been taken directly from the TISSEEL [Fibrin Sealant] Prescribing Information, 11/2014, the TISSEEL/ARTISS Spray Set Instructions for Use, and the EASYSPRAY Pressure Regulator Instructions for Use.
For Tech Support Call 1-888-229-0001, option 4
Please see full Indications for Use.
• CAUTION: Do not use rechargeable batteries.
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Do Not use rechargable batteries.
O2 Do Not connect to an oxygen source.
• CAUTION: Spraying into enclosed body cavities requires appropriate safety measures to make sure that the above mentioned risks will be avoided.
• WARNING: 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 maximum pressure provided in the appropriate spray set instructions for use.
Please see accompanying full Prescribing Information.
TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
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.
Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness can negatively interfere with wound healing.
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• 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.
• CAUTION: Pressurized gas supply must be between 3.5 and 7 bar.
The EASYSPRAY Pressure Regulator controls and releases pressurized gas provided by a propellant gas source. The EASYSPRAY Pressure Regulator is to be used only with spray sets specified for use with this pressure regulator.
EASYSPRAY INDICATIONS FOR USE
Hypersensitivity or allergic/anaphylactoid reactions can 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.
Do not spray TISSEEL where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Do not use TISSEEL for 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.
Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
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.
Important Risk Information for TISSEEL[Fibrin Sealant] 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, can result in life- threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients. To minimize the risk of intravascular application, exercise caution when using TISSEEL in surgery.
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.
Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface.
Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.
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.
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.
TISSEEL [Fibrin Sealant] Indications Hemostasis:TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (> 1 month of age) 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