Directions For Use - ev3 AXIUM Instrucciones De Uso

DIRECTIONS FOR USE

1 . Slowly and simultaneously remove the AXIUM™ Detachable Coil and introducer sheath from the dispenser track . Inspect proximal
implant delivery pusher for irregularities . If irregularities exist, replace with a new AXIUM™ Detachable Coil .
2 . Slowly advance the AXIUM™ Detachable Coil out of the introducer sheath into the palm of your gloved hand and inspect for irregularities
of the coil or the detachment zone . Due to potential risks of irregularities, a visual proof should be performed . If irregularities exist,
replace with a new AXIUM™ Detachable Coil .
1.
4.
1 . Implant
2 . Detachment Zone
3 . Coil Alignment Marker
3 . Gently immerse the AXIUM™ Detachable Coil and its detachment zone in heparinized saline . Take care not to stretch the coil during this
procedure, in order to preserve the coil memory . While still immersed in the heparinized saline, point introducer sheath vertically into
saline and gently retract the distal tip of the coil into the introducer sheath .
4 . Insert the distal end of the introducer sheath through the rotating hemostatic valve (RHV) and into the hub of the microcatheter until the
sheath is firmly seated . Tighten the RHV around the introducer sheath to prevent back flow of blood, but not so tight as to damage the
coil during its introduction into the catheter .
5 . Transfer the AXIUM™ Detachable Coil into the microcatheter by advancing the implant pusher in a smooth, continuous manner (1-2cm
strokes) . Once the flexible portion of the implant pusher has entered the catheter shaft, loosen the RHV and remove the introducer
sheath over the implant pusher's proximal end . Do not attempt to advance the entire implant pusher into the introducer sheath this may
cause kinking in the proximal pusher . Stop approximately 15 cm from the distal end of implant pusher . Once completed, tighten the RHV
around the implant pusher . Leaving the introducer sheath in place will interrupt normal infusion of flushing solution and allow back flow
of blood into the microcatheter .
6 . Visually verify that the flushing solution is infusing normally . Once confirmed, loosen the RHV enough to advance the implant pusher, but
not enough to allow back flow of blood into the implant pusher .
7 . Advance the AXIUM™ Detachable Coil under fluoroscopy and position carefully at the desired site . If coil placement is unsatisfactory,
slowly withdraw by pulling on the implant pusher, then slowly advance again to reposition the coil . If the coil size is inappropriate,
remove and replace with an appropriately sized coil .
a . If delivery pusher buckling or kinking is noted, grasp the distal most portion of the delivery pusher, distal to the kink, buckle or
break and remove from microcatheter .
WARNING
Do not use hemostats in an attempt to advance delivery pusher . This may result in a kinked pusher which may lead to premature
detachment .
8 . Continue to advance the AXIUM™ Detachable Coil until the coil alignment marker of the implant pusher is just distal of the proximal marker
of the microcatheter (See Figure 2) .
a . Advance coil alignment marker just beyond proximal catheter marker band, then retract delivery pusher until coil alignment marker
creates a "T" with the proximal catheter marker band under fluoroscopy . This relieves forward stress that may lead to false positive
detachment .
1.
2.
1 . Coil Alignment Marker
2 . Proximal Catheter Marker Band
9 . Tighten RHV to prevent movement of the implant pusher .
10 . Remove the I . D . (Instant Detacher) from its protective packaging and place it within the sterile field . I . D . (Instant Detacher) is packaged
separately as a sterile device for single patient use only .
11 . Confirm again under fluoroscopy that the coil alignment marker of the implant pusher creates a "T" with the proximal marker of the
microcatheter .
3.
2.
6.
5.
Figure 1
4 . Delivery Pusher
5 . Hypotube Break Indicator (HBI)
6 . Positive Load Indicator
3.
Figure 2
3 . Distal Catheter Marker Band
12 . Verify that the RHV is firmly locked around the implant pusher before attaching the I . D . (Instant Detacher) to ensure that the coil does
not move during the connection process . Ensure that the implant pusher is straight between the RHV and the I . D . (Instant Detacher) .
Straightening this section of the implant pusher optimizes alignment to the I . D . (Instant Detacher) .
13 . Hold the proximal end of the implant pusher at the distal end of the load indicator . Advance the I . D . (Instant Detacher) over the proximal
end of the implant pusher until the load indicator fully enters the funnel and the pusher is firmly seated in the actuator (See Figure 3) .
2.
4.
5.
1 . Proximal end of Load Indicator
2 . Grip pusher here when advancing I . D . (Instant Detacher)
over implant pusher .
3 . Advance I . D . (Instant Detacher) over implant pusher .
Note: If indicator band is still showing as in Figure 4 below, the I . D . (Instant Detacher) should be advanced further until the implant
pusher is fully seated in the funnel as in Figure 3 above .
1.
14 . To detach coil, place the I . D . (Instant Detacher) into palm and retract the Thumb-slide back until it stops and clicks, and slowly allow the
Thumb-slide to return to its original position . Remove the I . D . (Instant Detacher) .
Note: The I . D . (Instant Detacher) can also be removed at the end of stroke if desired . To remove the I . D . (Instant Detacher) at the end of
stroke, hold the thumb slide in its most rearward position and remove the I . D . (Instant Detacher) (see Figure 5) .
1.
1 . Ready to Detach 2 . Distal end of Load indicator fully in I . D . (Instant Detacher) funnel .
15 . Successful coil detachment must be verified by fluoroscopic monitoring to ensure that the coil has detached . Slowly pull back the implant
pusher while watching the fluoroscopy to make sure that the coil does not move . In the unlikely event the coil moves, repeat steps 12-14 .
If necessary, advance the implant pusher to re-establish the coil and catheter marker alignment . Verify coil detachment as above .
16 . I f you wish to confirm detachment, grasp the positive load indicator between your thumb and forefinger of your left hand and the
proximal end of the implant delivery pusher with your thumb and forefinger of your right hand . Gently pull on the proximal end of the
implant delivery pusher . If it moves freely from the hypo-tube, the system is detached properly . If it does not, repeat steps 13-15 .
Note: If the Coil does not detach after 3 attempts, discard the I . D . (Instant Detacher) and replace with a new I . D . (Instant Detacher) .
17 . In the rare event that the coil does not detach and cannot be removed from the implant delivery pusher, use the following steps for
detachment .
a . Grip the hypotube approximately 5cm distal of the positive load indicator at the hypotube break indicator and bend the
implant delivery pusher just distal to the HBI 180 degrees .
b . Next straighten the pusher back, continue bending and straightening until the pusher tubing opens exposing the release
element (Figure 6) .
4
1.
Figure 3
4 . Ready to Detach
5 . RHV and Implant pusher are in a straight line and distal end of
Load Indicator is fully inserted in the I . D . (Instant Detacher) funnel .
Figure 4
1 . Not Fully Loaded
2.
Figure 5
3.