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•
While it is essential to sufficiently tighten the microcatheter RHV around
the coil delivery wire prior to using the InZone
over-tightening the RHV could cause the delivery wire to kink.
•
Batteries are pre-loaded into the InZone Detachment System. Do not
attempt to replace batteries or open the enclosure.
•
Increased detachment times may occur when:
•
Other embolic agents are present.
•
Delivery wire and microcatheter markers are not properly aligned.
For proper alignment, see Figure B.
•
Thrombus is present on the coil detachment zone.
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The IZDS
Connecting Cable has been resterilized. The IZDS
®
Connecting Cable is supplied for one use only and should be
discarded after each procedure (Only applicable when detaching
GDC
or Matrix
Detachable Coils).
®
2®
•
If 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.
•
In some ECG equipment, perturbations may be observed immediately
before illumination of the CYCLE COMPLETE indicator on the InZone
Detachment System.
•
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
(only applicable when detaching GDC or Matrix
realign the delivery wire with the microcatheter, tighten the RHV, and
repeat the detachment procedure.
•
Needle must not be coated.
•
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.
•
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.
•
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
Detachable Coils.
2
•
The safety and performance characteristics of the InZone Detachment
System when used with another manufacturer's devices (whether coils,
coil delivery devices, catheters, guidewires, and/or other accessories),
have NOT been established. Due to the potential incompatibility of
non-Stryker Neurovascular components with the InZone Detachment
System, the use of another manufacturer's device(s) with the InZone
Detachment System is not recommended.
•
The InZone Detachment System needs special precautions regarding
Detachment System,
EMC. Use of the InZone Detachment System should be according to the
®
EMC information provided within these Directions for Use.
•
Portable and mobile RF communications equipment may affect the
performance of the InZone Detachment System.
6. aDVErSE EVEnTS
No adverse events are associated with the use of the InZone Detachment
System as a stand alone device. Failure to detach might result in prolongation
of the procedure or additional intervention. Refer to Stryker Neurovascular
Detachable Coil Directions for Use for adverse events associated with the use
of Stryker Neurovascular detachable coils.
Please notify your Stryker Neurovascular representative immediately if
a device malfunctions or patient complication or injury is experienced or
suspected associated with the use of this device. Please make every attempt
to retain any suspect device, its associated components and their packaging
for return to Stryker Neurovascular.
7. COnFOrManCE TO STanDarDS
The InZone Detachment System has been tested and conforms to EN 60601-1-
2:2007 "General Requirements for Basic Safety and Essential Performance -
Collateral Standard: Electromagnetic Compatibility - Requirements and Tests."
If interference is suspected while using the InZone Detachment System,
repositioning or reorienting the device may reduce or eliminate the interference.
8. HOw SUPPLIED
The InZone Detachment System is supplied STERILE using an ethylene oxide
(EO) process. Do not use if sterile barrier is damaged. Do not use if package is
opened or damaged. Do not use if labeling is incomplete or illegible. If damage
is found, contact your Stryker Neurovascular representative.
Detachable Coils),
2
The InZone Detachment System is packaged individually inside a protective
plastic tray. The tray is sealed with a peel-off breathable lid. The outside of
the tray, the four corner lips of the tray, and the peel-off lid are non-sterile; the
inside of the packaging (underneath the sealing rim) is sterile.
The IZDS Connecting Cable (UPN M00345110250 – sold separately) is
packaged separately inside a single, sealed pouch.
Handling & Storage
Store in a cool, dry, dark place.
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