- 4 -
Figure 4
– Position of Marker Bands for Detachment
To minimize the potential risk of aneurysm or vessel perforation
DO NOT
advance the distal end of the delivery system past the
distal tip of the microcatheter.
DETACHMENT OF THE COIL
32. The Azur Detachment Controller is pre-loaded with battery power
and will activate when a delivery pusher is properly connected. It
is in a “power off” mode when no delivery pusher is attached. It is
not necessary to push the button on the side of the Azur
Detachment Controller to activate it.
33. Verify that the RHV is firmly locked around the delivery pusher
before attaching the Azur Detachment Controller to ensure that
the coil does not move during the connection process.
34. Although the delivery pusher’s gold connectors are designed to
be compatible with blood and contrast, every effort should be
made to keep the connectors free of these items. If there appears
to be blood or contrast on the connectors, wipe the connectors
with sterile water or saline solution before connecting to the Azur
Detachment Controller.
35. Connect the proximal end of the delivery pusher to the Azur
Detachment Controller by firmly inserting the proximal end of the
delivery pusher into the funnel section of the Azur Detachment
Controller. See Figure 2.
36. When the Azur Detachment Controller is properly connected to
the delivery pusher, a single audible tone will sound and the light
will turn green to signal that it is ready to detach the coil. If the
detachment button is not pushed within 30 seconds, the solid
green light will slowly flash green. Both flashing green and solid
green lights indicate that the device is ready to detach. If the
green light does not appear, check to ensure that the connection
has been made. If the connection is correct and no green light
appears, replace the Azur Detachment Controller.
37. Verify the coil position before pushing the detachment button.
38. Push the detachment button. When the button is pushed, an
audible tone will sound and the light will flash green.
39. At the end of the detachment cycle, three audible tones will sound
and the light will flash yellow three times. This indicates that the
detachment cycle is complete. If the coil does not detach during
the detachment cycle, leave the Azur Detachment Controller
attached to the delivery pusher and attempt another detachment
cycle when the light turns green.
40. The light will turn red after the number of detachment cycles
specified on the Azur Detachment Controller labeling. DO NOT
use the Azur Detachment Controller if the light is red. Discard the
Azur Detachment Controller and replace it with a new one when
the light is red.
41. Verify detachment of the coil by first loosening the RHV valve,
then pulling back slowly on the delivery system and verifying that
there is no coil movement. If the implant did not detach, do not
attempt to detach it more than two additional times. If it does not
detach after the third attempt, remove the delivery system.
42. After detachment has been confirmed, slowly retract and remove
the delivery pusher.
Advancing the delivery pusher once the
coil has been detached involves the risk of aneurysm or
vessel rupture. Do NOT advance the delivery pusher once the
coil has been detached.
43. Verify the position of the coil angiographically through the guide
catheter.
44. Additional coils may be deployed into the lesion as described
above. Prior to removing the microcatheter from the treatment
site, place an appropriately sized guidewire completely through
the microcatheter lumen to ensure that no part of the last coil
remains within the microcatheter.
The physician has the discretion to modify the coil deployment
technique to accommodate the complexity and variation in
embolization procedures. Any technique modifications must be
consistent with the previously described procedures, warnings,
precautions and patient safety information.
SPECIFICATIONS FOR AZUR DETACHMENT CONTROLLER
Output voltage: 8 ± 1 VDC
Cleaning, preventative inspection, and maintenance: The
Azur Detachment Controller is a single use device,
preloaded with battery power, and packaged sterile. No
cleaning, inspection, or maintenance is required. If the
device does not perform as described in the Detachment
section of these Instructions, discard the Azur Detachment
Controller and replace it with a new unit.
The Azur Detachment Controller is a single use device. Do
not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the
device and/or lead to device failure which, in turn, may result
in patient injury, illness, or death. Reuse, reprocessing, or
resterilization may also create a risk of contamination of the
device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
Batteries are pre-loaded into the Azur Detachment
Controllers. Do not attempt to remove or replace the
batteries prior to use.
After use, dispose of the Azur Detachment Controller in a
manner consistent with local regulations.
PACKAGING AND STORAGE
The Azur system is placed inside a protective, plastic dispenser
hoop and packaged in a pouch and unit carton. The Azur system
and dispenser hoop will remain sterile unless the package is
opened, damaged, or the expiration date has passed. Store at a
controlled room temperature in a dry place.
The Azur Detachment Controller is packaged separately in a
protective pouch and carton. The Azur Detachment Controller
has been sterilized; it will remain sterile unless the pouch is
opened, damaged, or the expiration date has passed. Store at a
controlled room temperature in a dry place.
SHELF LIFE
See the product label for the device shelf life. Do not use the
device beyond the labeled shelf life.
MR INFORMATION
The coil implant has been determined to be
MR conditional
according to the terminology specified in the American Society for
Testing and Materials (ASTM) International, Designation: F2503-
08.
Non-clinical testing demonstrated that the coil implant is
MR
conditional
. A patient can be scanned safely, immediately after
placement under the following conditions:
Static magnetic field of 3 Tesla or less
Maximum spatial gradient field of 720 Gauss/cm or less
MRI-Related Heating
In non-clinical testing, the coil implant produced a maximum
temperature rise of 1.7°C during MRI performed for 15 minutes of
