Stryker InZone Mode D'emploi page 8

3. Once the SYSTEM READY light is on, and the GROUNDING indicator is
a steady amber light, press and release the DETACHMENT BUTTON to
begin the detachment process. When the DETACHMENT BUTTON has
been pressed and released, the GROUNDING indicator will turn off. 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 the detachment
system down in a stable position, rather than holding the detachment
system in a stable position.
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.
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4. The InZone Detachment System will deliver current for up to 75 seconds.
The CYCLE COMPLETE indicator will show solid green and the device will
make 3 short beeps if the cycle has completed in less than 75 seconds.
The CYCLE COMPLETE indicator will show blinking green and the device
will make one long beep if the cycle has completed in 75 seconds. All other
lights will turn off. All other lights will turn off.
5. 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, flush the system to clear any
contrast that may exist around the detachment zone, check and adjust
the grounding setup, realign the delivery wire with the microcatheter,
tighten the RHV, and repeat the detachment procedure.
6. 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.
7. 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
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with GDC Detachable Coils or Matrix
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Detachable Coils").
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DISPOSaL
warning: After use, the InZone Detachment System (excluding packaging)
should be handled and processed as biohazardous material. After use,
dispose of the InZone Detachment System unit in accordance with hospital,
administrative, and/or local government policy for the handling, processing,
and disposal of biohazardous materials.
Dispose of packaging, delivery wires, introducer sheaths, IZDS
Cable (UPN M00345110250, if applicable), and needle (if applicable) in
accordance with hospital, administrative, and/or local government policy.
12. TrOUBLESHOOTInG
Error Signals
• Grounding Indicator is blinking amber during GDC or Matrix
Detachable Coil detachment.
If the GROUNDING indicator is blinking amber after the InZone
Detachment System is slid over the delivery wire, the system needs
to be grounded. Follow grounding instructions under the section titled
"Using the InZone Detachment System with GDC Detachable Coils or
Matrix Detachable Coils." If grounding instructions have been followed
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and the GROUNDING indicator is still blinking, verify that the IZDS
Connecting Cable (UPN M00345110250) has secure connections, that
the needle is uncoated, that the coil is properly aligned, and that the coil
has not detached. If the GROUNDING indicator continues to blink, the
connecting cable and/or needle may need to be replaced.
• Grounding Indicator is lit after sliding the detachment system over
the Target Detachable Coil delivery wire.
If the GROUNDING indicator lights up after sliding the funnel of the
InZone Detachment System over the proximal end of the Target
Detachable Coil delivery wire, slide the system completely off the
delivery wire and then back on. If after several insertion attempts the
GROUNDING indicator keeps lighting up, replace the device and notify
your Stryker Neurovascular representative.
• Grounding Indicator does not light up after sliding detachment
system over a GDC or Matrix Detachable Coil delivery wire.
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If the GROUNDING indicator does not light up after sliding the funnel
of the InZone Detachment System over the proximal end of the GDC or
Matrix Detachable Coil delivery wire, slide the system completely off
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the delivery wire and then back on. If after several insertion attempts the
GROUNDING indicator is still not lit, replace the device and notify your
Stryker Neurovascular representative.
• Low Battery Indicator is blinking amber.
If the LOW BATTERY indicator begins to blink, the user should prepare
another InZone Detachment System for use. This blinking indicates that
the current system has only limited power remaining, and may not be
able to detach any more coils.
Connecting
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