10)
Allow the syringe pusher assembly to rebound backwards again and pull the syringe pusher assembly
backwards until all of the reconstituted ingredients are transferred from the vials (overhead view in Fig. A-4).
Note: If the On/Off Push Button is accidentally engaged during the reconstitution phase, the device may be
turned off with no detrimental effects. Use must be completed within two hours of reconstitution for optimal
results.
Turning the Adherus AutoSpray ET Dural Sealant Device On
11)
Push the On/Off button on the bottom of the device to "activate" the system prior to hydrogel spray
application (Fig. B-1).
Note: The Adherus AutoSpray ET Dural Sealant applicator should be activated prior to removal of the vial
adapter hubs, just prior to spray application, to avoid inadvertently clogging the nozzle.
Device and Treatment Site Preparation
12)
If not already on, push the On/Off button to turn on the Adherus AutoSpray ET Dural Sealant applicator (Fig.
B-1).
Note: The internal air pump is activated by pushing the On/Off button, providing an audible sound that the
system has been activated. If the audible sound from the pump is not present, discontinue use of the current
Adherus AutoSpray ET Dural Sealant unit and follow instructions in the Troubleshooting section.
13)
Prior to treatment delivery, orient the device so that the vials are pointed upwards and remove and discard
both vial adapter hubs by rotating the blue hubs counterclockwise until the hubs are ejected from the device
(overhead view in Fig. B-2).
14)
For optimal tissue adherence at the treatment site, ensure that 2 to 3 millimeter margins around the defect
are clear of blood, hemostatic agents or other loose tissues and that cerebrospinal fluid outflow is minimized.
15)
If necessary, bend or shape the extended tip nozzle to improve access to and/or visualization of the
treatment site.
Treatment Delivery
16)
To apply the prepared product, if not already on, push the On/Off button in to turn on the device.
17)
Orient the device such that the body of the applicator is pointed up and hold a piece of gauze approximately
5 to 10 centimeters above the nozzle (Fig. B-3).
18)
Apply firm even pressure to the center of the syringe pusher assembly until product begins to spray out of
the nozzle (Fig. B-3).
19)
Once a green sealant begins to form on the piece of gauze, stop depressing the syringe pusher assembly.
Adherus AutoSpray ET Dural Sealant is now ready for the treatment delivery.
10