Adherus Autospray Et Dural Sealant Sterilization Method And Device Disposal; Environmental Operating Conditions; How Supplied; Adherus Autospray Et Dural Sealant Operations - HyperBranch Adherus AutoSpray ET Dural Sealant NUS-009 Mode D'emploi

Adherus AutoSpray ET Dural Sealant Sterilization Method and Device Disposal

The following table details the method of sterilization and disposal of the Adherus AutoSpray ET Dural Sealant
device.
Description
Adherus
AutoSpray
ET Dural
Sealant

Environmental Operating Conditions

Storage Temperature
Operating Temperature

How Supplied

The components of the Adherus AutoSpray ET Dural Sealant package are:
Adherus AutoSpray ET Dural Sealant kit tray (1)
Pre-Assembled applicator (1)
Activated PEG powder in green capped vial (1)
PEI solution in silver capped vial (1)

Adherus AutoSpray ET Dural Sealant Operations

The following sections give instructions for preparing and powering Adherus AutoSpray ET Dural Sealant.

Reconstituting the Crosslinking Components

1)
Using aseptic technique, introduce the contents of the outer tray labeled Adherus AutoSpray ET Dural
Sealant into the sterile field.
2)
Remove the lid from the Adherus AutoSpray ET Dural Sealant kit tray.
3)
Remove the pre-assembled Adherus AutoSpray ET Dural Sealant applicator.
4)
With the device oriented such that the extended tip nozzle is pointing up, remove and discard the red caps
covering the spikes on the blue vial adapter hubs on the applicator (Fig. A-1).
Note: It may be necessary to use hemostats or a similar tool to remove the caps. A twisting motion while
removing the cap is also recommended.
5)
Remove the vial containing PEI solution (silver capped vial) from the tray and seat the capped end into the
blue vial adapter hub of the applicator corresponding to the white syringe plunger by grasping the applicator
and fully depressing the vial so that the spike penetrates the septa and the silver aluminum seal bottoms out
in the vial adapter hub (Fig. A-2).
6)
Remove the vial containing the PEG ester powder (green capped vial) from the tray and seat the capped
end into the blue vial adapter hub of the applicator corresponding to the green syringe plunger by grasping
the applicator and fully depressing the vial so that the spike penetrates the septa and the green aluminum
seal bottoms out in the vial adapter hub (Fig. A-2).
7)
With the vials oriented upward, depress the syringe pusher assembly to transfer the liquids into the vials.
Continue to depress the syringe pusher assembly (Fig. A-3).
Note: Use two hands to depress the syringe pusher assembly if necessary.
8)
With the syringe pusher assembly still depressed, gently shake the device intermittently until the powder is
completely dissolved (Fig. A-3).
Note: The PEG ester powder will continue to dissolve in between periods of gentle shaking; overly
aggressive shaking can cause excessive entrapped air bubbles.
9)
Release the syringe pusher assembly to allow it to rebound backwards and depress a second time to ensure
both solutions are homogeneous.
Sterilization
Part Number
Method
Radiation
NUS-009
Noise Level
Frequency of
Use
AutoSpray ET Dural Sealant
Single Use Only
device in a hospital approved
Do not place in the trash!
Store below 30
o
5 C to 35
≤60 db
9
Method of Disposal
Dispose of the Adherus
biohazard container.
o
C
o
C