Johnson & Johnson Codman ORBIT GALAXY Bedienungsanleitung Seite 3

How Supplied
This product is for single use only; do not resterilize and/or reuse the product.
Codman & Shurtleff will not be responsible for product that is resterilized, nor accept
for credit or exchange product that has been opened but not used.
As long as the pouch is not opened or damaged, the product is sterile and nonpyrogenic.
"Use by" Date
The last date on which the device can be used is the last day of the month indicated
next to the "Use by" symbol on the packaging. Example: a date of "2009 – 03" means
that March 31, 2009 is the last date on which the product can be used.
Preparation for Use
In addition to the ORBIT GALAXY Detachable Coil System and the TRUFILL DCS Syringe II,
the following items are recommended:
• Sheath Introducer
• .014" or .018" (0,35 mm or 0,46 mm) guidewire compatible infusion catheter, 59.05 in
(150 cm) long, dual marker band such as PROWLER 14, PROWLER SELECT LP ES,
PROWLER PLUS, PROWLER SELECT PLUS, and RAPIDTRANSIT
Caution: Compatibility with other products has not been established.
• appropriate size guiding catheter for the selected infusion catheter
• appropriate size steerable guidewire for the selected infusion catheter
• rotating hemostasis valves (RHV)
• 3-way stopcock
• 1-way stopcock
• 3 cc luer lock syringe
• 27 gauge, 1" (25.44 mm) needle
• sterile saline solution
• appropriate flush solution
Detachable Coil Selection
Appropriate selection of the detachable coil is critical to ensure device effectiveness and
patient safety. Examine pre-embolization angiograms in order to choose the optimum device
for any given lesion. It is important to select the optimum coil length, coil diameter, and coil
type to ensure desired volumetric filling.
Continuous Flush Setup
See Figure 2. In order to achieve optimal performance and to reduce risk
of thromboembolic complications, it is critical that a continuous infusion
of appropriate flush solution be maintained between:
• the sheath introducer and the guiding catheter,
• the guiding catheter and the infusion catheter, and
• the infusion catheter and the steerable guidewire or the detachable coil.
1. Attach a line for continuous infusion of appropriate flush solution to the side port of the
sheath introducer.
2. Attach an RHV to the hub of the guiding catheter. Attach a 3-way stopcock to the side
arm of the RHV, and then connect a line for continuous infusion of appropriate flush solution.
3. Attach a second RHV to the hub of the infusion catheter. Attach a 1-way stopcock to
the side arm of the RHV, and then connect a line for continuous flushing of appropriate
flush solution. One drop from a pressure bag every 3–5 seconds or at a rate of 2–5 cc/min
is recommended.
Caution: Secure all fittings so that air is not introduced.
Instructions for Use
1. Select an appropriate detachable coil.
2. Remove the dispenser tube from the carton and pouch.
3. Prepare the syringe with sterile saline solution as instructed in the syringe instructions for
use. If the syringe was previously used to detach a coil, confirm the maximum number
of coil detachments or attempts is not exceeded. Refer to the syringe instructions for use.
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 system from functioning properly.
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Purging of the Detachable Coil Delivery Tube
1. Confirm the syringe latch mechanism is in the locked position.
Caution: Failure to secure the latch mechanism in the locked position could result
in syringe malfunction.
2. Purge the syringe of air and visually confirm that there are no trapped air bubbles in the
barrel or extension tubing of the syringe.
Caution: Introduction of air emboli could occur during coil detachment if all air is
not removed from the syringe during syringe preparation.
3. If using the luer valve provided, connect it to the hub of the delivery tube, and then securely
connect the syringe fitting to the valve. Otherwise, securely connect the syringe fitting
directly to the hub of the delivery tube.
Warning: Do not flush the hub of the delivery tube prior to connecting it with
the syringe or valve. The system must be discarded if the hub of the delivery tube
was flushed prior to connection with the syringe.
Caution: Protect the inner lumen of the hub and/or valve from contaminants.
Contaminants will prevent the detachable coil from functioning properly.
4. Increase the pressure in the syringe by rotating the knob clockwise until the pressure
gauge indicator enters position 1, blue zone.
Caution: Do not exceed the red line beyond position 1 during any part of the purging
operation. Excess pressure during preparation could lead to detachment of the coil
during the purging operation. If the red line beyond position 1 is exceeded at any point
during preparation, visually inspect the detachable coil to confirm coil attachment.
5. Maintain purging pressure at position 1, blue zone, for at least 30 seconds.
6. After 30 seconds of purging, rotate the syringe knob counterclockwise until the pressure
gauge indicator returns to position 2, orange zone.
Caution: Do not reduce the purging pressure below position 2, orange zone.
7. Unlock the latch mechanism to relieve any possible vacuum.
Caution: A sustained vacuum can cause air to be introduced into the delivery tube
through the purge hole.
8. Relock the latch mechanism and visually confirm that the hub is completely free of
air. If any air is present in the hub, disconnect the syringe and remove the valve (if
applicable) from the hub. Follow System Reconnection steps, and purge the device
for 30 seconds. If bubbles still appear in the hub, the detachable coil system must
be discarded.
Warning: Introduction of air emboli could occur during coil detachment if saline
purge of the delivery tube with visual confirmation is not performed properly.
9. If the luer valve is in place, the syringe may be disconnected until ready to detach the coil.
10. If the luer valve is not used, syringe connection with the delivery tube must be
maintained through coil detachment.
Coil Inspection
Caution: Maintain the syringe gauge indicator at position 2, orange zone, during
coil inspection.
1. Carefully remove the detachable coil system from the dispenser tube.
2. While holding the tab and the delivery tube with one hand, slide the zipper distally
approximately 3.93 in (10 cm) to release the coil introducer.
3. Expose the coil up to its attachment point outside the introducer by gently pushing
the delivery tube into the port at the proximal end of the introducer. See Figure 4.
4. Inspect the coil and attachment point for damage. Discard if damaged.
5. Recapture the coil by gently retracting the delivery tube into the introducer.
6. Secure the delivery tube by sliding the zipper proximally over the port.
Coil Introduction
Caution: Maintain the syringe gauge indicator at position 2, orange zone, during
coil introduction.
1. Insert the coil introducer through the second RHV and seat the tip into the hub of the
infusion catheter.
Caution: The placement of the coil introducer must not interrupt continuous flush.
If interruption occurs and/or blood flows into the hub of the infusion catheter,
reestablish proper flushing rates before proceeding.
2. Lightly lock the second RHV onto the coil introducer, taking care not to crush the coil
introducer. See Figure 5.
3. While holding the tab and the delivery tube with one hand, slide the zipper distally to
the stopper.
Caution: Failure to hold the tab and the delivery tube could result in the delivery tube
moving out of the coil introducer and exposing the flexible section of the delivery
tube or exposing the coil.
Caution: Fluoroscopy is required to ensure that the infusion catheter tip does not
move from its intended position.
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