Stryker InZone Mode D'emploi page 5

System Error Mode
If the InZone Detachment System detects that it is not working properly or
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cannot accurately regulate current output, all five LEDs will collectively light
up. If this occurs, do not use the detachment system and notify your Stryker
Neurovascular representative.
11. OPEraTIOnaL InSTrUCTIOnS
required additional Items
note: The InZone Detachment System can detach a minimum of 20 Stryker
Neurovascular detachable coils before battery life runs out.
Caution: Prior to beginning a procedure, confirm that there are enough
detachment systems on the shelf to complete the anticipated number of
detachments required. In addition, one extra InZone Detachment System is
required as backup for all procedures. Verify that the InZone Detachment
Systems to be used are within their indicated shelf life.
In procedures using GDC Detachable Coils and/or Matrix
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the following are also required:
• IZDS Connecting Cable (UPN M00345110250, sold separately)
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• A sterile 20- or 22-gauge uncoated stainless steel hypodermic needle
(sold separately)
Caution: One extra IZDS Connecting Cable (UPN M00345110250) and
sterile 20- or 22-gauge uncoated stainless steel hypodermic needle are
required as backup for all procedures using the InZone Detachment
System to detach GDC or Matrix Detachable Coils. Verify that the cables
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and needles to be used are within their indicated shelf life.
PrEParaTIOnS FOr USE
Coil Placement
Prior to attempting detachment of a Stryker Neurovascular coil, deploy the
coil so that the whole of the delivery wire alignment marker has crossed
the whole of the microcatheter proximal marker and is aligned as shown in
Figure B. If the proximal end of the delivery wire marker is not beyond the
distal end of the proximal microcatheter marker, the coil detachment zone may
not be sufficiently outside the microcatheter tip and may not have adequate
conductivity to detach properly.
Proximal Marker of the
Delivery Wire just beyond
Proximal Marker of the
Detachment
2-Tip Microcatheter
Zone
Stryker Coil
Distal and Proximal Markers of the 2-Tip Microcatheter
Figure B. Proper Coil & Microcatheter alignment
Continuous Flush Setup
In order to achieve expected detachment times and to reduce the risk of
thromboembolic complications, it is critical that a continuous infusion of
appropriate flush solution be maintained between a) the femoral sheath and
guiding catheter, b) the guiding catheter and the 2-tip microcatheter, and c) the
2-tip microcatheter and the delivery wire. Continuous flush also reduces the
potential for thrombus formation on, and crystallization of infusate around, the
Stryker Neurovascular Coil detachment zone. For proper saline flush setup, see
the Directions for Use provided with the Stryker Neurovascular detachable coil.
For Target ® Detachable Coils, GDC Detachable Coils, and Matrix
Detachable Coils:
One drop from the pressure bag through the empty microcatheter every
3-5 seconds is suggested.
For GDC-18 Fibered Vortx
One drop from the pressure bag through the empty microcatheter every
1-3 seconds is suggested.
Detachable Coils,
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DIrECTIOnS FOr USE
Prior to using the InZone Detachment System, confirm that the coil to be
detached is appropriately placed and that the microcatheter RHV is tightened
around the coil delivery wire to prevent further movement of the coil.
Caution: While it is essential to sufficiently tighten the microcatheter RHV
around the coil delivery wire prior to using the InZone Detachment System,
over-tightening the RHV could cause the delivery wire to kink.
removal From Packaging
The InZone Detachment System is ready for use upon removal from its
packaging:
1. Verify the packaging is intact. Do not use an InZone Detachment System
if packaging is damaged.
2. A non-sterile user should peel back the breathable cover of the tray
to reveal the sterile detachment system inside, taking care not to
compromise device sterility.
3. A sterile user can reach in and lift the detachment system out of its tray,
or a non-sterile user can turn the tray upside-down to lightly drop the
detachment system into the sterile field, taking care not to compromise
device sterility.
4. Inspect detachment system for damage. Do not use the InZone
Detachment System if it is damaged.
2-Tip
Caution: Batteries are pre-loaded into the InZone Detachment System.
Microcatheter
Do not attempt to replace batteries or open the enclosure.
Delivery Wire
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2
Coils:
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