Stryker InZone Mode D'emploi page 7

USInG THE InZOnE DETaCHMEnT SYSTEM wITH GDC
®
COILS Or MaTrIx DETaCHaBLE COILS
2®
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.
• T he IZDS Connecting Cable has been resterilized. The IZDS Connecting
®
Cable is supplied for one use only and should be discarded after each
procedure.
Grounding the System
1. Open the IZDS Connecting Cable (UPN M00345110250 – sold separately)
pouch to obtain the single, sterile black connecting cable, taking care
not to compromise the sterility of the cable. Inspect the cable for
damage. Do not use the cable if damaged.
2. Obtain a sterile 20- or 22-gauge uncoated stainless steel hypodermic
needle and inspect for damage, taking care not to compromise the
sterility of the needle. Do not use the needle if damaged.
Caution: Needle must not be coated.
3. Insert needle in the patient's thigh or groin, taking care not to hit a blood
vessel or nerve.
4. Attach the female plug of the connecting cable to the male port on
the proximal end of the InZone Detachment System. Figure C shows
the connecting cable and InZone Detachment System aligned for this
connection.
5. Attach the clip on the connecting cable to the needle, taking care not to
touch patient's skin with the clip and the wire. Check that there is good
contact and there is no blood in between the clip and the surface of the
needle.
Caution: If the patient experiences pain at the site of the needle, or if
detachment times are increasing, replace the needle with a new needle
at a new insertion site.
Caution: The IZDS Connecting Cable is intended for single patient use
only. Do not resterilize and/or reuse. Resterilization could corrode the
connecting cable, resulting in increased detachment times.
DETaCHaBLE
®
Figure C. InZone Detachment System with the IZDS Connecting Cable
(M00345110250)
Detaching GDC Coils and Matrix
1. Wipe the proximal end of the GDC or Matrix
wire with alcohol.
2. Gently slide the funnel of the InZone Detachment System over the proximal
end of the GDC or Matrix
curvature or tension on the delivery wire just distal to the funnel, 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, and the patient is correctly grounded, the detachment system
will beep, the SYSTEM READY (OK) indicator will show solid green and the
GROUNDING indicator will be a steady amber light. If significant resistance
is encountered during advancement, and the detachment system has
not powered on, gently remove the detachment system and repeat
the detachment procedure. If grounding setup is complete, and the
GROUNDING indicator is still blinking amber, refer to the Troubleshooting
section of this DFU, under the subheading "Grounding Indicator is
blinking amber during GDC or Matrix
If GROUNDING indicator is not lit (blinking or steady) after sliding the
InZone over the proximal end of the GDC or Matrix
delivery wire, please refer to the Troubleshooting section of this DFU,
under the subheading "Grounding Indicator does not light up after sliding
detachment system over a GDC or Matrix
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.
Caution: Disconnection or poor connection of any part of the grounding
setup after the detachment system indicates SYSTEM READY may result
in an inability to detach GDC or Matrix
7
IZDS Connecting Cable
Coils
2
Detachable Coil delivery
2
Detachable Coil delivery wire, minimizing any
2
Detachable Coil detachment.".
2
Detachable Coil
2
Detachable Coil delivery wire.".
2
Detachable Coils.
2