Johnson & Johnson Codman ORBIT GALAXY Bedienungsanleitung Seite 5

Warning: Do not advance the marker bands of the delivery tube past the marker
band of the infusion catheter. Advancing the marker bands of the delivery tube
past the marker band of the infusion catheter results in the forward movement of
the tip of the delivery tube past the infusion catheter which risks damaging the
vessel and displacing the coil.
7. If coil detachment is confirmed, release the pressure on the syringe by rotating the
syringe knob counterclockwise until the gauge indicator enters position 2, orange zone.
Disconnect the syringe fitting from the hub. Completely open the second RHV and
carefully remove the delivery tube from the patient.
Warning: Failure to open the second RHV sufficiently prior to slow and careful
removal of the delivery tube from the patient could result in damage to the distal
portion of the delivery tube.
Caution: As position 3, green zone, has been exceeded, do not reuse the syringe
for additional coil detachments. Disconnect the syringe from the detachable coil
unit and properly discard them.
8. If the coil fails to detach, release the pressure on the syringe by rotating the syringe
knob counterclockwise until the gauge indicator enters position 2, orange zone. Remove
the coil from the patient. Refer to Coil Retrieval. Replace both the detachable coil system
and the syringe.
Coil Retrieval
1. Confirm that the syringe gauge indicator reads position 2, orange zone.
2. Under fluoroscopy, retract the coil by carefully withdrawing the delivery tube from the
second RHV. Continue withdrawing the delivery tube until the coil is completely housed
within the lumen of the infusion catheter (approximately 3.93 in (10 cm) from the distal
end of the infusion catheter).
Precautions and Warnings
• Hold the infusion catheter body in place while the coil is removed to prevent the infusion
catheter tip from moving from the intended position.
• Do not withdraw or torque the delivery tube against resistance without fi rst determining
the cause of the resistance under fl uoroscopy. These manipulations of the delivery
tube against resistance can cause damage and/or premature detachment of the coil.
• During coil retraction, verify under fl uoroscopy that a one-to-one relationship exists
between the delivery tube and the coil. If not, the coil has been stretched, which could
lead to premature detachment or coil fracture. If the one-to-one relationship does not
exist, remove the infusion catheter and the detachable coil as an assembly and replace.
3. Firmly hold the hub of the delivery tube with one hand. Simultaneously grasp the introducer
just distal to the stopper with the other hand and slide the coil introducer distally along
the delivery tube. Insert the coil introducer through the second RHV and seat the tip of
the introducer into the hub of the infusion catheter.
4. Lightly lock the second RHV onto the coil introducer, taking care not to crush the coil
introducer. Confirm that the flush rate is maintained.
5. Firmly hold the coil introducer just distal to the stopper with one hand. Simultaneously,
withdraw the delivery tube until the exposed length of the delivery tube is sufficient to
accommodate the full length of the coil introducer.
Caution: During withdrawal, do not expose the blue distal flexible section of the
delivery tube, as the delivery tube could sustain damage.
6. While maintaining a firm hold of the coil introducer distal to the stopper, slide the zipper
proximally along the full length of the coil introducer. See Figure 10. Do not slide the zipper over
the port. Sliding the zipper over the port will lock the coil introducer onto the delivery tube.
7. Retract the coil by carefully withdrawing the delivery tube from the proximal end of the
coil introducer. Continue withdrawing the delivery tube until the coil is completely housed
within the distal tip of the coil introducer.
Caution: Flush the coil and delivery tube continuously during retraction to prevent
clot formation.
8. Slide the zipper proximally over the port to lock the coil introducer onto the delivery tube.
9. Completely open the second RHV and carefully remove the delivery tube and coil introducer
as a unit from the patient.
Warning: Failure to open the second RHV sufficiently prior to slow and careful removal
of the delivery tube from the patient could result in damage to the distal portion of the
delivery tube.
System Reconnection
1. See syringe instructions for use. Prepare the syringe with sterile saline solution. If the syringe
was previously used to detach a coil, confirm the maximum number of coil detachments
or attempts is not exceeded.
206598-001-B.indd 5 206598-001-B.indd 5
Caution: The sterile saline solution used to fill the syringe must be obtained
directly from a sterile saline bag or dedicated sterile saline flush line. To prevent
any contaminants from being introduced into the lumen of the delivery tube, the
sterile saline solution must not be aspirated from a separate mixing container;
e.g., glass beaker. Contaminants will prevent the coil from functioning properly.
2. Confirm the syringe latch mechanism is in the locked position.
3. Purge the syringe of air.
Warning: Visually confirm there are no trapped air bubbles in the barrel or extension
tubing of the syringe. The introduction of air emboli could occur during coil detachment
if all air is not removed from the syringe.
4. Using a 27 gauge, 1" (25.44 mm) needle and a 3 cc luer lock syringe, flood the hub of
the detachable coil delivery tube with sterile saline by placing the tip of the needle at the
distal lumen of the hub and injecting the saline as the needle is retracted proximally.
Caution: The sterile saline solution used to fill the 3 cc syringe must be obtained
directly from a sterile saline bag or dedicated sterile saline flush line. To prevent
any contaminants from being introduced into the lumen of the delivery tube, the
sterile saline solution must not be aspirated from a separate mixing container;
e.g., glass beaker. Contaminants will prevent the coil from functioning properly.
Warning: Visually confirm there are no trapped air bubbles in the lumen of the hub.
The introduction of air emboli can occur during coil detachment if saline flush of
the delivery tube hub is not properly performed prior to reconnection of the syringe.
5. Reconnect the syringe fitting to the hub of the delivery tube or to the luer valve if used.
Caution: Protect the inner lumen of the hub from contaminants. Contaminants in the
hub prior to syringe connection will prevent the coil from functioning properly.
Warranty
Codman & Shurtleff, Inc., warrants that this medical device is free from defects in both
materials and workmanship. Any other express or implied warranties, including
warranties of merchantability or fitness, are hereby disclaimed. Suitability for use
of this medical device for any particular surgical procedure should be determined
by the user in conformance with the manufacturer's instructions for use. There are
no warranties that extend beyond the description on the face hereof.
® CODMAN, TRUFILL, PROWLER, SELECT, and RAPIDTRANSIT are registered trademarks
of Codman & Shurtleff, Inc.
™ ORBIT GALAXY is a trademark of Codman & Shurtleff, Inc.
Codman Neurovascular is a business unit of Codman & Shurtleff, Inc.
FRANCAIS
INFORMATIONS IMPORTANTES
À lire avant utilisation
Système à coil détachable ORBIT GALAXY™
Le coil détachable de remplissage ORBIT GALAXY
Le coil détachable rigide ORBIT GALAXY
Description
Le système à coil détachable ORBIT GALAXY se compose d'un système d'insertion
(tube d'insertion et introducteur de coil) et d'un coil d'embolisation résistant à l'étirement.
Le tube d'insertion constitue le corps du dispositif et fait fonction à la fois de guide et
de mini cathéter de perfusion. L'introducteur de coil est conçu pour protéger le coil dans
son emballage de distribution et pour faciliter l'introduction du coil dans le cathéter de
perfusion. Le coil représente la partie implantable du dispositif. Voir figure 1. Il intègre un
monofilament en polymère résistant à l'étirement dans son diamètre intérieur. Le système
est conçu pour utilisation sous surveillance fluoroscopique, avec un cathéter de perfusion
de 150 cm de long, à deux marqueurs annulaires, compatible avec un guide de 0,35 mm
ou 0,46 mm, tels que les cathéters PROWLER
® ®
PROWLER Plus, PROWLER SELECT
n'est disponible quant à la compatibilité avec d'autres cathéters de perfusion.
5
® ® ®
14, PROWLER SELECT LP ES,
® ®
Plus et RAPIDTRANSIT . Aucune donnée
5/21/2010 4:57:10 PM 5/21/2010 4:57:10 PM