Stryker InZone Mode D'emploi page 6

USInG THE InZOnE DETaCHMEnT SYSTEM wITH TarGET
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Caution: Increased detachment times may occur when:
• Other embolic agents are present.
• Detachment zone is in contact with the coil mass.
• Delivery wire and microcatheter markers are not properly aligned.
For proper alignment, see Figure B.
• Thrombus is present on the coil detachment zone.
Detaching Target Detachable Coils
1. Wipe the proximal end of the Target Detachable Coil delivery wire
with alcohol.
2. Using the left index finger and thumb, gently grasp the Target
Detachable Coil delivery wire approximately 3 cm from the proximal end
of the wire. Keep the delivery wire still.
3. Holding the InZone Detachment System with the right hand, gently slide
the funnel of the InZone Detachment System over the proximal end of
the Target Detachable Coil delivery wire, minimizing any curvature or
tension on the delivery wire just distal to the funnel.
4. Once the proximal end of the delivery wire has entered the funnel,
move the left hand further distal on the delivery wire and continue to
gently advance the funnel over the wire until the delivery wire butts
against the inside of the detachment system. When the delivery wire
and the detachment system's internal contacts are properly touching,
the detachment system will beep and the SYSTEM READY (OK) indicator
will show solid green. If significant resistance is encountered during
advancement, and the detachment system has not powered on, gently
remove the InZone Detachment System and repeat the detachment
procedure. If the GROUNDING indicator is lit, please refer to the
Troubleshooting section of this DFU, under the subheading "Grounding
Indicator is lit after sliding the detachment system over the Target
Detachable Coil delivery wire."
warning: Sliding the detachment system with too much force or failing
to tighten the microcatheter RHV prior to detachment may cause
the delivery wire to kink or result in displacement of the coil and/or
microcatheter tip in the vessel, which could lead to failed detachment,
suboptimal coil position post-detachment, vessel perforation, aneurysm
perforation, pseudoaneurysm, or aneurysm rupture. Do not advance
the InZone Detachment System over the coil delivery wire against
significant resistance.
5. Once the SYSTEM READY light is on, press and release the
DETACHMENT BUTTON to begin the detachment process. While
current is flowing, the CURRENT FLOW indicator will show solid green
and all other lights will turn off. The user may choose to set down
the detachment system in a stable position rather than holding the
detachment system prior to, or during, the detachment process.
DETaCHaBLE COILS
®
Caution: When the device is set down, take care to gently place it in a
stable position so that it does not slide off of the delivery wire during
detachment. If device is held, take care to gently hold it in a stable position
so that it does not slide off of the delivery wire during detachment.
Caution: In some ECG equipment, perturbations may be observed
immediately before illumination of the CYCLE COMPLETE indicator on the
InZone Detachment System.
6. The InZone Detachment System will deliver current for up to 10 seconds.
The CYCLE COMPLETE indicator will show one of the following signals and
all other lights will turn off.
• O n the first cycle, a signal of three short beeps and a solid green
light indicates that the InZone has assessed that detachment has
likely occurred.
• O n the first cycle, a signal of one long beep and a blinking green
light indicates that the InZone has assessed that detachment has
not occurred.
• F or the second cycle, regardless of signal type, detachment has
likely occurred.
7. Gently slide the detachment system off of the proximal end of the
delivery wire and set the unit down on a level, sterile surface. Verify
under fluoroscopy that the coil has detached by slowly pulling back on
the delivery wire and monitoring the fluoro image to make sure the coil
does not move.
Caution: Because coils are not always detached following completion
of a cycle, ALWAYS verify under fluoroscopy that the coil has detached
by slowly pulling back on the delivery wire while monitoring the fluoro
image to make sure there is no movement of the coil. In the unlikely
event the coil moves (indicating it is still attached to the delivery wire),
check and adjust the flush system, realign the delivery wire with
the microcatheter, flush the system to clear any contrast that may
exist around the detachment zone, tighten the RHV, and repeat the
detachment procedure.
8. Once coil detachment has been fluoroscopically confirmed, slowly
withdraw the delivery wire from the microcatheter.
warning: Advancing the coil delivery wire beyond the microcatheter
tip once the coil has detached may increase the risk of aneurysm or
vessel rupture.
9. If additional coil placement is required, select and place the
coil(s) following the Directions for Use provided with each Stryker
Neurovascular detachable coil. Once the next coil is placed, follow the
detachment steps from the appropriate InZone Detachment System
Directions for Use section ("Using the InZone Detachment System with
Target Detachable Coils" or "Using the InZone Detachment System with
GDC Detachable Coils or Matrix
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6
Detachable Coils").
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