apollo endosurgery X-Tack Gebrauchsanweisung Seite 8

7 .12. Remove Cinch device from scope channel.
Disposal
Dispose of any used or explanted devices or device components in accordance with any local regulations for medical waste.
MRI Safety Information
MR Conditional
Non-clinical testing has demonstrated that the X-Tack™
Endoscopic HeliX Tacking System is MR Conditional.
CMR Statement - The stainless steel components
within this device contain the following substance(s)
defined as a CMR (carcinogenic, mutagenic or toxic to
Troubleshooting
Channel Liner Protrudes from Scope
Cause
Field of view obscured by protruding channel liner from
scope.
Resistance Felt During Device Insertion
Cause
Resistance felt during device insertion.
HeliX Tack Disengages from Driver While Inside Patient But Before Intended
Cause
If the user attempts to retract a HeliX Tack back into the scope
liner, the eyelet of the HeliX Tack can catch on the scope liner
and disengage the Tack from the driver.
A HeliX Tack can disengage prematurely if the Tack is not
properly loaded onto the driver.
Excessive Resistance During Device Insertion
Cause
Excessive resistance felt during device insertion in a
straight scope, scope working channel may be damaged or
obstructed.
7 .13. Remove Bracket from scope.
A patient with this device can be safely scanned in an
MR system under the following conditions:
- Static magnetic field of 1.5 -Tesla and 3-Tesla only.
- Maximum spatial field gradient
(extrapolated) and less.
- Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of 2 W/kg
for 15 minutes of scanning (ie. per pulse sequence)
in the normal operating mode.
reproduction) 1A/1B and/or endocrine disrupting in a
concentration above 0.1% weight by weight:
Cobalt (CAS No. 7440-48-4; EC No. 231-158-0)
Resolution
Retract channel liner funnel at the biopsy cap
Resolution
Stop advancing the catheter and straighten the scope to facilitate the device passage. Reposition scope for
treatment.
Resolution
Never attempt to withdraw a disengaged HeliX Tack through the driver because it may damage the scope.
If the first HeliX Tack disengages, the suture can be drawn such that the HeliX Tack is held against the distal end
of the scope liner. Then, withdraw the scope, scope liner, X-Tack catheter and HeliX Tack together as a single unit.
Reattach the HeliX Tack, outside the patient. You should feel a pop as it engages with the driver. Pull the catheter
with loaded HeliX Tack carefully back into the scope liner, taking care not to disengage the HeliX Tack, and begin
again.
If the second or third HeliX Tack disengages in the patient, adjust the suture pattern and cinch. These HeliX
Tacks cannot be re-engaged with the driver. If the 4th HeliX Tack disengages, leave it and cinch the construct. If
necessary, use another X-Tack device to complete the closure.
Resolution
Flush working channel or use different scope.
8
In non-clinical testing, the X-Tack™ Endoscopic HeliX
Tacking System produced a temperature rise of 1.5º C
or less at a maximum extrapolated WBA SAR of
2.0 W/kg for 15 minutes of continuous MR scanning
of 25 T/m
with body coil in both 1.5 T/64 MHz and 3T/128 MHz
MR System Scanners.
In non-clinical testing, the image artifact caused by the
Anchoring System extends approximately 16-mm from
this device when imaged with a gradient echo pulse
sequence and a 3-Tesla MRI system.
Current scientific evidence supports medical devices
manufactured from these cobalt alloys or stainless
steels containing cobalt do not cause increased risk of
cancer or adverse reproductive effects.
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