Stryker InZone Mode D'emploi page 2

InZone
®
Detachment System
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order
of a physician.
warnInG
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if
sterile barrier is damaged. If damage is found, call your Stryker Neurovascular
representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/
or lead to device failure which, in turn, may result in patient injury, illness
or death. Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious disease(s) from one
patient to another. Contamination of the device may lead to injury, illness or
death of the patient.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.
1. InTrODUCTIOn/DEVICE DESCrIPTIOn
The InZone Detachment System is a sterile, handheld, single-patient-use device
designed for use with Stryker Neurovascular Detachable Coils (Target
and Matrix ). The device consists of a handle with a detachment button, five
2®
LED indicator lamps, a funnel inset at its distal end, and a cable connection
port. The device comes pre-loaded with two AAAA batteries. An IZDS
Connecting Cable (UPN M00345110250) is required to detach GDC Detachable
Coils and Matrix Detachable Coils, and must be used in conjunction with a
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return electrode (a sterile 20- or 22-gauge uncoated stainless steel hypodermic
needle). Stryker Neurovascular coils and the IZDS Connecting Cable are sold
separately. The return electrode is also sold separately.
2. InTEnDED USE/InDICaTIOnS FOr USE
The InZone Detachment System is intended for use with all versions of Stryker
Neurovascular detachable coils in the embolization of intracranial aneurysms
and other vascular malformations of the neuro and peripheral vasculature.
3. COnTraInDICaTIOnS
None known.
4. warnInGS
This device should only be used by physicians who have received
appropriate training in interventional neuroradiology or interventional
radiology and preclinical training on the use of this device as established
by Stryker neurovascular.
• The InZone Detachment System can only be used with Stryker
Neurovascular detachable coils (Target, GDC, and Matrix
Connecting Cable. DO NOT SUBSTITUTE any components or devices
from other manufacturers or injury to the patient or user could result.
• Advancing the coil delivery wire beyond the microcatheter tip once the
coil has detached may increase the risk of aneurysm or vessel rupture.
• 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.
• 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 Connecting Cable (UPN
M00345110250, if applicable), and needle (if applicable) in accordance
with hospital, administrative, and/or local government policy.
• The use of cables and/or other medical devices other than the IZDS
Connecting Cable specified may result in increased emissions or
decreased immunity of the InZone Detachment System.
, GDC , • The InZone Detachment System should not be used adjacent to or
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stacked with other equipment; if adjacent or stacked use is necessary,
the InZone Detachment System should be observed to verify normal
operation in the configuration in which it will be used.
®
• No modification of the equipment is allowed.
5. CaUTIOnS
• 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.
• 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
and needles to be used are within their indicated shelf life.
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) and the IZDS
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Detachable Coils. Verify that the cables
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