Codman ORBIT GALAXY G2 Información Importante página 3

8. Check to ensure that all fittings are secure and that no air is being introduced
into the system during active flushing.
IV Pole
Flush Line
Device Positioning
Unit Connection
Remote Detach Button
(EnPOWER Control Cable only)
Detachment
RHV
Control RHV
Box (DCB)
One-Way
Stopcock
Flush Line
DCB Output Connector
Standard Connection or EnPOWER
Control Cable
Guide Catheter
Infusion Microcatheter
Distal Marker Band
(Microcatheter)
Proximal Marker
Band (Microcatheter)
Fig. 2: Delivery System Set Up with Continuous Flush
MICROCOIL SYSTEM PREPARATION
Verify the functionality of the Microcoil Delivery System before proceeding with
microcoil placement. This needs to be done with the microcoil still in the hoop.
To verify proper DCB and microcoil functionality a connecting cable and microcoil
must be connected to the DCB unit. After verification of the DCB and connecting
cable, turn off power to the DCB and disconnect the connecting cable from
the microcoil until the microcoil is ready to be detached. Please refer to the
Detachment Control Box Instructions for Use section, located near the end of this
document, before proceeding.
Removing Microcoil System from Packaging Hoop
1. Grasp the base of the DPU's hub connector, and gently slide it completely
out of the retaining clip. Be sure to keep the hub connector in line with the
retaining clip until the entire connector is out.
2. Gently grasp the DPU wire hub and slowly pull the entire Microcoil System
from the packing hoop. Do not bend the DPU wire as the device is pulled
from the packing hoop as this may result in damage to the device.
Inspecting the Microcoil
1. Hold the introducer sheath (loosely-looped) in the left hand. Keeping the
introducer tip near the re-sheathing tool, grasp the distal end of the
re-sheathing tool between your left thumb and forefinger
2. Grasp the clear tab near the end of the introducer sheath body with the
thumb and forefinger of your other hand. Gently pull the clear tab of the
introducer sheath out and away from the re-sheathing tool at a 45-degree
angle to unlock the microcoil. Continue to pull the tab until an additional
0.5 to 1.0 in (1.3 to 2.5 cm) of the translucent material is exposed.
3. Gently fold the translucent tab towards the distal end, and firmly grasp the
distal end of the re-sheathing tool and the translucent tab between your
thumb and forefinger, as shown in Figure 3.
4. Place the introducer tip of the Microcoil System into a heparinized saline bath.
5. Gently advance the DPU wire through the introducer sheath to inspect the
coil. It should move smoothly through the sheath.
Fig. 3: Holding the introducer tip and re-sheathing tool with
the clear tab between your thumb and forefi nger. The coil tip
is also shown emerging from the introducer tip
Three-Way
Stopcock
Guide Catheter
Hub
Microcatheter Hub
Flush Line
Femoral Sheath
Guide Catheter
Aneurysm
Microcoils
Illustration Not to Scale
3
6. Continue to push the DPU wire until the entire microcoil is exposed.
7. Visually examine the microcoil for any anomalies such as kinks, burrs, stretched coil,
striations, or other damages. If any anomalies are Noted or if there is difficulty advancing
the microcoil from the introducer sheath, the unit may be defective. Repackage
the microcoil and return the entire device to Codman & Shurtleff or an authorized
representative for replacement.
8. Once the visual inspection is complete, gently pull the microcoil back so that no portion
of the coil is exposed out of the end of the introducer tip.
9. The Microcoil System is now ready to be introduced into the hub of the appropriately
sized microcatheter.
Microcoil Placement
Introducing the Microcoil System
1. Loosen the main valve of the RHV attached to the infusion microcatheter hub.
2. Gently insert the introducer tip into the RHV until it can go no further and is in close
alignment with the hub of the infusion microcatheter. (There may be a small space, as
shown in Figure 4, between the tip and hub depending on the type of microcatheter
used.) Gently tighten the RHV main valve around the introducer sheath to prevent back-
flow of blood. Visually inspect the alignment of the introducer tip and the microcatheter
hub to ensure they have not slipped apart.
Fig. 4: Aligning the Introducer Tip
CAUTION: Do not fasten the RHV valve too tightly around the introducer sheath since
excessive pressure may cause damage to the introducer sheath and/or the microcoil
as it is advanced into the infusion microcatheter. Additionally, if the introducer tip and
microcatheter hub are misaligned, damage may occur to the microcoil as it passes
through this transition.
3. While holding the distal end of the re-sheathing tool and translucent introducer sheath
together between your thumb and forefinger, as was done previously during coil inspection,
advance the DPU wire through the introducer sheath into the infusion microcatheter. As the
microcoil passes through the introducer tip into the microcatheter hub, continuously verify
that the introducer tip and microcatheter hub remain aligned. Continue to advance the DPU
wire until its hub connector reaches the proximal end of the re-sheathing tool.
4. Return to the infusion microcatheter's RHV. Loosen the RHV and gently slide the
introducer tip out from the RHV, over the DPU wire. Once a small section of the exposed
DPU wire is visible, tightly grasp it with the thumb and forefinger of the same hand that is
holding the RHV. Using the thumb and forefinger of your other hand, grasp the introducer
tip, slowly slide it away from the RHV over the DPU wire. Continue sliding the introducer
tip until just before the tip reaches the distal end of the re-sheathing tool, leaving
approximately 1 inch of the unsheathed introducer sheath still visible.
5. Using fluoroscopic guidance, slowly advance the Microcoil System through the infusion
microcatheter to the site of the aneurysm. Continually verify the Microcoil System's
progress and final position in the aneurysm using fluoroscopic guidance.
CAUTION: If unusual friction is noticed during advancement or retraction of the Microcoil
System, verify the locking mechanism, or clear tab is unlocked and pulled out from the
resheathing tool approximately 1 in. (2–3 cm).
CAUTION: If unusual friction is still noticed during advancement or retraction of the
Microcoil System, verify flush lines are open and properly pressurized. Then slowly
withdraw the entire Microcoil System and examine for damage. Replace it with a new
Microcoil System. If friction still exists, withdraw and examine the delivery catheter system.
CAUTION: If the Microcoil System becomes immobile in the infusion microcatheter, apply
a gentle push-pull motion to free it. If unsuccessful, remove both microcatheter and
Microcoil System together as a unit and replace with new devices.
CAUTION: Do not attempt to use the Microcoil System as a guidewire if positioning of
the microcatheter is lost during microcoil deployment.
CAUTION: If repositioning of the microcoil is necessary, carefully observe the motion of
the microcoil in respect to the DPU wire while retracting the microcoil under fluoroscopy.
If the microcoil movement is not one-to-one with the DPU wire, or if repositioning is
difficult, the microcoil may have become stretched and could possibly break. Gently
remove and discard the Microcoil System.
CAUTION: If the microcoil is positioned at a relative sharp angle to the microcatheter, a
microcoil may stretch or break as it is being withdrawn. By repositioning the distal tip of
the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more
easily funneled back into the microcatheter.
Minimal Gap