Johnson & Johnson Codman ORBIT GALAXY Bedienungsanleitung Seite 4

4. Introduce the detachable coil into the infusion catheter by gently pushing the delivery
tube into the port at the proximal end of the coil introducer until the blue flexible portion of
the delivery tube is well inside the infusion catheter hub. A distance of approximately
12 in (30 cm) between the strain relief and the tab of the introducer will ensure that the
delivery tube is inside the infusion catheter hub. See Figure 6.
Caution: During initial introduction, visually confirm through the hub of the infusion
catheter that the coil is entering the infusion catheter in a straight line and that the
blue flexible section of the delivery tube is well within the infusion catheter hub.
5. Confirm that the zipper on the coil introducer is adjacent to the stopper to properly
complete coil introduction.
6. Unlock the second RHV and withdraw the distal tip of the coil introducer to expose
the delivery tube. See Figure 7.
7. Lock the RHV onto the stainless steel portion of the delivery tube.
8. Firmly hold the exposed portion of delivery tube with one hand. Simultaneously, grasp
the introducer just distal to the stopper with the other hand and slide the coil introducer
proximally along the delivery tube until the coil introducer has stripped itself from the
delivery tube, up to the zipper. See Figure 8. The delivery tube will remain within the
distal portion of the coil introducer. Reconfirm proper flushing rates are maintained.
Coil Placement
Caution: The syringe gauge indicator must be maintained at position 2, orange zone,
during coil placement.
1. Unlock the second RHV.
2. Under fluoroscopy, deploy the detachable coil by carefully pushing the delivery tube into
the proximal end of the second RHV. Continue pushing the delivery tube to position the
coil within the desired vascular location. Hold the infusion catheter body in place while the
coil is delivered to prevent the infusion catheter tip from moving from its intended position.
Caution: Repositioning the infusion catheter while the coil is deployed can lead to
damage and/or premature detachment of the coil.
Caution: Never advance, withdraw, or torque the delivery tube against resistance
without first determining the cause of resistance under fluoroscopy. Manipulation
of the delivery tube against resistance can cause damage and/or premature
detachment of the coil. If unusual friction is noted within the infusion catheter,
remove the detachable coil system. Refer to Coil Retrieval. If friction is noted with
any subsequent detachable coil system, carefully examine the detachable coil
system and the infusion catheter for possible damage. Replace both if necessary.
Refer to Coil Retrieval.
3. If coil repositioning is required, gently withdraw and then re-advance the coil.
Caution: If coil repositioning in the vasculature is required, verify under fluoroscopy
that a one-to-one relationship exists between the delivery tube and the coil during
retraction. Although the coil is stretch resistant, failure of the delivery tube and the
coil to retract at the same rate indicates that the coil may have stretched which
could lead to premature detachment or coil fracture. If a one-to-one relationship
does not exist, remove the infusion catheter and the coil as an assembly and
replace. If desired placement or stability cannot be achieved, the coil must be
removed from the patient. Refer to Coil Retrieval.
4. Continue advancing the coil until the window between the two proximal marker bands
on the delivery tube encompasses the proximal marker band on the infusion catheter.
See Figure 9. At this position, the coil is fully deployed and ready for detachment.
Warning: Incorrect alignment of marker bands can result in excessive forces on the
treatment site or inappropriate coil placement.
Warning: If undesirable movement of the coil can be seen under fluoroscopy
following coil placement and prior to detachment, remove the coil and replace
with a more appropriately-sized coil. Movement of the coil can indicate the
coil could migrate once it is detached. Angiographic controls must also be
performed prior to detachment to ensure that the coil mass is not protruding
into the parent vessel.
Coil Detachment
Caution: If saline fluid leaks from the syringe, or the threaded plunger strips and does
not allow the syringe to obtain the required pressure anytime during the detachment
procedure, the syringe should be replaced. To replace the syringe, release the pressure
on the syringe without repositioning the coil, by rotating the syringe knob counterclockwise
until the gauge indicator enters position 2, orange zone. Disconnect the syringe from the
hub of the delivery tube. Prepare a new syringe and reconnect to the hub of the delivery
tube. Refer to System Reconnection. After connecting new syringe, proceed with the
detachment procedure.
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1. Under fluoroscopy, confirm that the coil is in the proper position for detachment and
that it is not protruding into the parent vessel. If using the luer valve, securely connect
the syringe fitting to the valve.
Caution: When using the luer valve, if air enters the hub upon reconnection
of the syringe, disconnect the syringe and remove the valve. Refer to System
Reconnection. After connecting the syringe, proceed with the
detachment procedure.
Warning: If desired coil placement or stability cannot be achieved, the coil must be
removed from the patient. Refer to Coil Retrieval.
2. Prior to detaching the coil, carefully confirm that the distal ends of the infusion catheter
and delivery tube are not under stress.
Warning: Tensile or compressive stresses can result in forward movement of the
infusion catheter, delivery tube movement, and movement of some portion of the
coil which can lead to improper coil detachment.
3. Securely tighten the second RHV onto the delivery tube to prevent movement of the coil
during detachment.
4. Increase the pressure in the syringe by rotating the syringe knob clockwise until the gauge
indicator enters position 3, green zone.
Caution: Do not exceed position 3, green zone, as this could cause the syringe
to lose calibration. If position 3, green zone, has been exceeded, do not reuse the
syringe for additional coil detachments. Maintain the pressure in position 3, green
zone for approximately 3 seconds. Rapidly decreasing pressure indicates that the coil
has been detached; however, detachment must be confirmed under fluoroscopy.
5. Coil detachment must be confirmed under fluoroscopy by releasing the second RHV
and slowly retracting the delivery tube ensuring that the coil is not being retracted into
the tip of the infusion catheter and that the delivery tube marker bands move away from
the coil without resistance.
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 forward movement of the
tip of the delivery tube past the infusion catheter and risks damaging the vessel
and displacing the coil.
6. 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. Discard the delivery tube. If the maximum number of
coil detachments or attempts has not been exceeded, the syringe can be reused for
additional coil detachments. Otherwise, properly discard the syringe. See syringe
instructions for use.
Caution: Do not unlock the latch mechanism on the syringe if the pressure indicator
is beyond position 2, orange zone, as this can cause damage to the syringe threads.
In this event, do not reuse the syringe for additional coil detachments.
7. If detachment is not confirmed, proceed to Alternative Coil Detachment.
Alternative Coil Detachment
1. Under fluoroscopy reposition the coil and reconfirm that the coil is in the proper position
for detachment and that it is not protruding into the parent vessel.
Warning: If desired coil placement or stability cannot be achieved, the coil must be
removed from the patient. Refer to Coil Retrieval.
2. Prior to detaching the coil, confirm that the distal ends of the infusion catheter and delivery
tube are not under stress.
Warning: Tensile or compressive stresses can result in forward movement of the
infusion catheter, delivery tube movement, and movement of some portion of the
coil which can lead to improper coil detachment.
3. Securely tighten the second RHV onto the delivery tube to prevent movement of the coil
during detachment.
4. Increase the pressure in the syringe by rotating the syringe knob clockwise until the gauge
indicator reaches the end of the red zone.
Warning: Do not exceed the red zone. High pressures could cause the syringe latch
mechanism to crack and/or fragment.
5. Maintain pressure in this position for approximately 3 seconds. Rapidly decreasing pressure
indicates that the coil has been detached.
6. Coil detachment must be confirmed under fluoroscopy by releasing the second RHV
and slowly retracting the delivery tube ensuring that the coil is not being retracted into
the tip of the infusion catheter and that the delivery tube marker bands move away from
the coil without resistance.
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