apollo endosurgery X-Tack Gebrauchsanweisung Seite 6

2.4. If the eyelet is not flush with the mucosal surface,
rotate the Handle and Slider CLOCKWISE (CW)
to drive HeliX Tack further into tissue.
NOTE: In cases of retroflexion, manual turns
may be required to fully seat the HeliX Tack.
WARNING: Excessive manual rotation could
damage the device causing the HeliX Tack to
skip on the driver.
2.5. If placement is NOT satisfactory, reverse HeliX
Tack by gently pulling back on device catheter
while slowly PUSHING Handle Slider to the 'R'
position until the HeliX Tack is fully released from
the tissue.
2.6. If HeliX Tack remains engaged in tissue, hold
the Push Catheter with the left hand, and
rotate both the Handle Slider and the Handle
COUNTERCLOCKWISE (CCW) with the right
hand until the HeliX Tack is fully released from
tissue.
NOTE: Continue to gently pull back on device
catheter and ensure the Handle Slider remains
in the 'R' position throughout.
NOTE: Maintain visualization when attempting
to disengage HeliX Tack from tissue to ensure
it is turning CCW.
NOTE: Several turns of the Handle and Finger
Slider may be required before HeliX Tack
begins to rotate and can be safely removed
from tissue.
2.7 . Re-target tissue and Drive HeliX Tack according to
the placement instruction above.
3. HeliX Tack Deployment
3.1. Ensuring that the Handle Slider is in the Drive
'D' position, press and hold the Push Catheter
Release Button (blue) then advance the Pusher
forward (away from Handle) until the hard stop
is reached.
'click'
3.2. Visually verify correct HeliX Tack deployment.
'pop'
4. Reset the device
4.1. Reset the device by sliding the Pusher back to
locked position until it 'clicks' in place.
NOTE: Ensure the Push Catheter Release
Button (blue) is not being pressed during this
action.
4.2. Push Handle Slider to position 'R'.
NOTE: If significant resistance is felt while
advancing or retracting device, reduce scope
tortuosity.
NOTE: If needed, control slack by pulling
Suture.
5. Reload the device
5.1. Remove device from working channel.
5.2. Remove Reload Pill #2 from Backer Card by lifting
the distal end of Pill and sliding downwards.
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5.3. Securing the Reload Pill between fingers, hold the
distal end of the catheter approximately 2 inches
from the tip and insert into the embedded HeliX
Tack until a 'pop' is felt.
NOTE: Ensure the Push Catheter is in the
locked position prior to re-loading.
5.4. Continue moving the device catheter forward
through the Reload Pill until the HeliX Tack is
removed. Discard the Reload Pill.
CAUTION: Do not to squeeze the pill too
tightly during reload as this will risk damaging
the HeliX Tack.
CAUTION: Visually verify that HeliX Tack is
installed to device. If Helix appears not fully
seated carefully hold Helix between thumb
and index finger and insert distal end of device
into the HeliX Tack until a 'pop' is felt.
5.5. While holding Suture tension, slowly advance
HeliX Tack along Suture and insert into working
channel.
NOTE: Do not retract device catheter from
the working channel whilst a HeliX Tack is
installed; this could lead to device damage or
inadvertent detachment.
6. Continue HeliX Tack Placement
6.1. Repeat steps to target tissue and implant further
HeliX Tacks.