Floseal Preparation



Preparation

Components 1
Thrombin powder
Needle free vial adapter
Components 2
FLOSEAL gelatin matrix syringe
Empty syringe
Connector
Applicator tips
Step 1
Inspect the integrity of the contents of the FLOSEAL Kit. If the packaging or vial has been damaged or opened, do not use.
Step 2
Open the package containing the NaCl ampoule and deliver the ampoule to the sterile field using an aseptic technique.
Step 3
Open the outer pouch of the thrombin component and deliver the inner pouch to the sterile field. Once placed in the sterile field, the inner package may be opened at any time.
Step 4
Open the outer pouch of the gelatin matrix component and deliver the inner pouch to the sterile field. Once placed in the sterile field, the inner package may be opened at any time.
Step 5
Take care not to misplace the white luer connector.
Step 6
Remove the Tyvek lid from the vial adapter packaging.
Step 7
Remove twist-off cap from the Sodium Chloride ampoule.
Step 8
While gripping the vial adapter packagings, attach the vial adapter to the pre-filled NaCl ampoule using a luer lock motion and remove the vial adapter packaging.
Step 9
Remove the plastic flip-off cap from the Thrombin vial.
Step 10
Wlile holding the vial adapter, pierce the rubber stopper of the Thrombin vial. Transfer the entire contents of the NaCl ampoule into the Thrombin vial.
Step 11
Gently swirl the Thrombin vial with vial adapter and ampoule attached until the Thrombin is completely dissolved. Remove the empty NaCl ampoule and discard.
Step 12
Attach the white luer connector to the empty 10ml syringe. With the white luer connectorin place connect the empty syringe to the vial adapter on the Thrombin vial.
Step 13
Draw the thrombin solution from the vial to the indicated mark (8 ml). Discard the empty Thrombin vial and the vial adapter appropriately ensuring that the white luer connector remains connected to the syringe.
Step 14
Remove the cap from the Gelatin Matrix Syringe carefully to avoid spilling the Gelatin Matrix granules. Connect the Gelatin Matrix Syringe to the syringe containing 8 ml of Thrombin solution using the white luer connector.
Step 15
Push the plunger of the Thrombin solution syringe to quickly pass the solution into the syringe containing the Gelatin Matrix. This constitutes "one pass". Transfer the Gelatin Matrix Thrombin solution mixture back and forth between the syringes for a total of 10 passes back and forth.
Step 16
Ensure the syringe labelled FLOSEAL contains the reconstituted FLOSEAL Matrix. If desired, connect an Applicator Tip or Malleable Tip to the FLOSEAL syringe
Step 17
FLOSEAL may be used up to 8 hours after mixing with the Thrombin Solution. Allow 30 seconds after preparation before FLOSEAL is applied to ensure optimal product consistency.
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Content by Dr Íomhar O' Sullivan. Last review Dr ÍOS 12/01/25.