PRODUCT OVERVIEW

MECHANISM OF ACTION

CLINICAL STUDIES

SURGICAL EXAMPLES

PREPARATION

ACCESSORIES

INSTRUCTIONS FOR USE

IMPORTANT SAFETY INFORMATION

PRODUCT EVALUATION

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Preparation

The COSEAL Kits Includes:

LIQUID COMPONENTS POUCH
Consists of two syringes containing solutions, preassembled into delivery housing.

POWDER COMPONENT POUCH
Consists of a syringe containing two polyethylene glycols, or PEGs, in powder form.

APPLICATOR POUCH
Contains two applicator tips.

1. Remove the luer cap on the transfer port closure. Do not remove the syringe clip.

2. Remove the luer cap from the powder syringe.

3. Connect the powder syringe to the opening on the transfer port closure. Transfer the liquid into powder by forcefully depressing the plunger. Mix contents back and forth between the syringes at least 20 times, until the solid is completely dissolved. Push entire contents into the syringe contained in the syringe housing.

4. Disengage the powder syringe by detaching the transfer port closure as follows:

• Grasp the powder syringe barrel
• Press the levers on the syringe housing
• Pull both the empty powder syringe and transfer port closure from the housing

5. Holding the syringe tips up, level syringe plungers and rotate the syringe clip to connect to other plunger. Hold the syringe upright and expel all air.

6. Snap the applicator onto the end of the syringe housing. COSEAL sealant is now ready to use. If a clear gel is desired, wait approximately 3 minutes after mixing.

APPLICATION

Note: For peripheral vascular graft procedures, restore blood circulation to the surgical site to expand the graft. Reclamp to stop circulation.

1. Aspirate excess blood and blot or air dry all surfaces prior to application.
2. Hold the applicator approximately 3 cm from the site (touching the site or holding more than 6 cm from the site is not recommended). Apply sealant forcibly to enhance mixing, moving quickly along the anastomotic site.
3. If COSEAL sealant is to be applied to another site several minutes after first application, immediately wipe the applicator tip with gauze and set device upright to prevent clogging.
4. Apply a uniform layer of sealant to the treatment site. If necessary, rotate the site and bend the applicator to facilitate exposure of all surfaces. Overlap the application slightly to ensure complete coverage of the treatment site. Following application wait at least 60 seconds before restoring circulation, applying irrigation, blotting with gauze, or touching the sealant.
5. If the material remains "watery" and does not gel within approximately 30 seconds, flush the site with saline, and aspirate the material.
6. If the treated site fails to seal, blot the surface dry. Reclamping the vessel may be required to dry the field for reapplication of COSEAL sealant. Reapply sealant. Do not disturb the sealant. If the sealant does not seal, flush the site with saline, aspirate and use standard treatment.
7. If the applicator becomes clogged, replace it with a new applicator as follows: Press the ribbed surface of levers on the syringe housing and remove the clogged applicator. Attach the new applicator.

For more detailed instructions, please download the COSEAL Instructions for Use.