Codman ORBIT GALAXY G2 Información Importante página 4

Positioning the Microcoil
1. The proper alignment of the marker bands is illustrated in Figure 5. The infusion
microcatheter has two distal tip marker bands located three (3) cm apart. The Microcoil
System has a distal marker band three (3) mm from the detachment mechanism. To
obtain proper positioning of the Microcoil System for detachment under fluoroscopic
guidance, align the radiopaque marker on the DPU wire just past the proximal marker
band on the tip of the microcatheter.
2. Once the desired microcoil placement has been achieved, gently tighten the RHV around
the DPU wire to maintain its position.
Microcoil
Detachment Zone
Fig. 5: Proper Marker Band Alignment
DETACHING THE MICROCOIL
1. Re-verify the position of the microcoil within the aneurysm via fluoroscopy. The Microcoil
System is now ready for detachment.
2. Press the power button on the Detachment Control Box (DCB), if not already powered on.
3. Attach the connecting cable to the connector end of the DPU wire, ensuring that it is
fully seated. If not already connected, attach the other end of the connecting cable to the
output connector of the DCB.
4. Verify that the Microcoil Delivery System is fully connected and no faults are indicted
on the DCB. If a fault exists, reseat all connections between the DPU, the DCB, and
the connecting cable. If a fault still persists, replace the connecting cable. If this does
not correct the error, replace the DCB. If the Microcoil Delivery System still continues to
have a fault, retrieve the microcoil as described in the following section, re-sheathing the
Microcoil System, and replace with a new Microcoil System.
5. If the system is free of faults, depress the Detach button on the Blue EnPOWER DCB or
the EnPOWER Control Cable. The Detach Cycle light next to the button will illuminate
and an intermittent tone will sound for the duration of the detachment cycle. If the light
and audible tone do not activate, replace the DCB.
6. After the light goes out and the tone stops, detachment of the microcoil from the
DPU wire must be fluoroscopically verified by gently withdrawing the DPU wire back
approximately one (1) mm. Observe if the microcoil has detached.
• If the microcoil did not detach and no fault light is illuminated or flashing, repeat the
steps above.
• If a fault light is detected, the System Ready light is not illuminated, or there is no
detachment after two detachment attempts, replace the DCB unit.
• If detachment still does not occur, carefully withdraw the entire Microcoil System and
redeploy a new Microcoil System.
7. After detaching the coil, remove the DPU wire from the microcatheter and discard.
Note: Do not disconnect the connecting cable from either the DCB or DPU wire during a
detachment cycle.
CAUTION: Always perform fluoroscopic verification of detachment prior to withdrawing
the DPU wire fully. Failure to do so may lead to an embolic complication.
8. Repeat the above sequence for all additional microcoils until the procedure is complete.
Note: If it is determined that the microcoil will not be detached, simply disconnect
it from the connecting cable and remove it from the microcatheter as outlined in the
following section.
RE-SHEATHING THE MICROCOIL SYSTEM
When necessary, the Microcoil System can be reloaded into the introducer sheath using the
re-sheathing tool.
1. Loosen the RHV. Using the fluoroscopic guidance, retract the Microcoil from the
aneurysm back into the Microcatheter.
2. Locate the introducer tip. Grasp the introducer tip with your left hand and the resheathing
tool with your right hand. Pull with your right hand while holding on the resheathing tool
towards the connector. This will start the resheathing of the coil and the DPU pusher wire.
3. When the resheathing tool reaches the end of the introducer sheath, replace the
introducer tip back inside the RHV. Tighten the RHV.
4. With your right hand, grasp the connector and continue to pull the DPU wire out of the
sheath until coil is completely inside the distal end of the introducer tip.
5. Loosen the RHV and remove the introducer.
Microcatheter Marker Bands
Device Positioning
Unit
Microcatheter Shaft
Microcoil Marker Band
Fig. 6: Pulling Back the DPU Wire Hub Connector
CAUTION: Pulling the exposed microcoil through the RHV grommet may
damage the coil.
CAUTION: Do not pull the DPU wire back too far since it may cause a softer
section of the DPU wire to become exposed. An arm's length pull should
re-sheath the coil.
6. Once the device is fully retracted, slide the re-sheathing tool over the DPU/
introducer sheath body until the system is relocked.
7. Loosen RHV and remove device. If needed, the Microcoil System is now
ready to be re-inserted.
INSTRUCTIONS: BLUE EnPOWER DETACHMENT CONTROL BOX
VERIFY PROPER FUNCTIONALITY OF DCB
Note: This DCB contains no user replaceable batteries.
Note: The EnPOWER DCB has an automatic shut off after ½ hour of non-use. If
the DCB automatically shuts off, press the Power button to restart.
1. Press the Power button on the front panel of the DCB. All indicator lights
will illuminate briefly then turn off while the unit performs a self test. With
no cables connected, only one of the battery indicator lights should
be illuminated.
• If the green Full Battery light is illuminated, the DCB is
functioning properly.
• If the amber Low Battery light is illuminated, then the DCB will function
properly, but less than 100 detach cycles remain on the unit.
• If the red Dead Battery light is illuminated, the DCB will NOT function.
Replace with new DCB.
• If the red System Fault light, or no light, is illuminated, then the DCB
is NOT functioning properly. The unit should not be used and should
be returned to Codman & Shurtleff or an authorized representative
for replacement.
2. Once verification of the DCB is complete and the DCB is functioning properly,
mount the DCB onto an IV pole or equivalent mounting device.
Note: Using a flathead screwdriver or a thin coin, the clamp on the back of
the DCB may be removed and the DCB inserted into a sterile sleeve so the
device may be placed in the sterile field.
VERIFICATION OF CABLE CONNECTION
1. Open a sterile Codman connecting cable into the sterile field.
2. Pass the larger diameter connector out of the sterile field. The remainder of
the connecting cable must remain in the sterile field.
3. Insert the larger cable connector into the DCB output connector until a click
is felt.
VERIFICATION OF MICROCOIL SYSTEM
1. Select the appropriate Microcoil System based on the aneurysm's
angiographic assessment.
2. Inspect the microcoil packaging for any breach of sterility.
3. Open the sterile peel-pouch containing the selected Microcoil System and
remove the hoop containing the Microcoil System from the pouch.
4. With the Microcoil System remaining in the hoop, connect the smaller
connector on the connecting cable to the hub connector of the Microcoil
System's Device Positioning Unit (DPU) wire, and power on the DCB. The
green System Ready light will illuminate when both the cable and microcoil
are connected to the DCB and functioning properly.
• If the System Ready light does not illuminate, check all cable connections.
• If the System Ready light still does not illuminate, unplug the Microcoil System
from the cable and select a new cable. Follow the steps outlined above and
attach the new cable. Connect the existing Microcoil System to the new cable.
If the System Ready light is now illuminated, the Microcoil Delivery System
is functioning properly. Re-package the malfunctioning cable, and return it to
Codman & Shurtleff or an authorized representative for replacement.
Note: The Codman connecting cable should not be re-sterilized or reused.
Re-sterilization may damage the unit making it non-functional. Re-sterilized
connecting cables will not be replaced by Codman & Shurtleff.
• If the System Ready light still does not illuminate, select a replacement
Microcoil System. Repeat the steps above to remove the microcoil
from its sterile package. With the Microcoil System remaining in the
4