LeMaitre AnastoClip GC Instructions D'utilisation page 2

AnastoClip GC®
(Model Numbers 4007-06, 4007-07, 4007-08)
English — Instructions for Use
IMPORTANT!
This booklet is designed to assist in using the AnastoClip GC® Closure System with titanium clips. It is not a reference to
surgical stapling techniques.
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
Indications
The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular
structures when tissue penetration is desired.
Effects
The AnastoClip GC applier is available in three (3) clip sizes: medium-1.1 mm, large-1.7 mm and extra large-2.5 mm. The
AnastoClip GC applier consists of a rotating shaft and an integral cartridge containing titanium clips. As the levers of the
applier are squeezed together, the clip is closed around the everted tissue edges. As the levers are released, a new clip is
automatically loaded into the clip applier jaws. It is recommended to use the Tissue Everting Forceps to aid in the everting of
the tissue edges and the AnastoClip
MR Compatibility
Non-clinical testing demonstrated that the AnastoClip GC Closure System is MR Conditional. A patient with this device can be
scanned safely in an MR system under the following conditions:
• Static magnetic field of 1.5-Tesla and 3-Tesla, only
• Maximum spatial gradient magnetic field of 2,000-Gauss/cm (20-T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of
scanning (i.e., per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the AnastoClip GC Closure System is expected to produce a maximum temperature rise of
1.5°C after 15-minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by
the AnastoClip GC Closure System extends approximately 4-mm from this implant when imaged using a gradient echo pulse
sequence and a 3-Tesla MR system.
Schematic View And Nomenclature
A) Clips
B) Jaws
C) Shaft
D) Rotation Knob
E) Levers
F) Handle
Designs available:
AnastoClip Applier
3" (7.6 cm) Shaft
Instructions For Use
NOTE: It is recommended to wear loupes. A 2.5X magnification is suggested.
1. Preparation of tissues is recommended as follows:
G) ARTERIOTOMY OR VENOTOMY: One optional stay suture at mid-incision.
H) END-TO-END: Horizontal mattress sutures at 3 and 9 o'clock.
I) END-TO-SIDE: Horizontal mattress sutures heel and toe: stay sutures at 3 and 9 o'clock.
J) SIDE-TO-SIDE: Horizontal mattress sutures at 12 and 6 o'clock: stay sutures at 3 and 9 o'clock.
NOTE: Additional sutures may be placed depending on the length of the closure, in order to facilitate a
symmetrical eversion.
2. Symmetrically evert all tissue layers for secure nonpenetrating clip placement. Evert the tissue
edges of the vessel with either design of tissue everting forceps. Ensure that all tissue edges are
symmetrically everted prior to applying the clip. Failure to symmetrically evert the tissue edges
properly can result in possible bleeding or leakage.
3. Inspect the tissue wall to ensure that the forceps do not damage tissue during manipulation.
NOTE: Atraumatic Tissue Everting Forceps are designed to minimize potential damage to blood
vessels or other small tubular structures.
4. Place the instrument jaws onto the everted tissue edges to be anastomosed, making certain
that the tissue fits completely within the confines of the jaws. The tissue must comfortably fit
within the confines of the jaws, or the use of the instrument is contraindicated.
5. Squeeze the levers together fully until a discernible click is felt. As the levers are squeezed, the
clip is held firmly in the jaws and closed around the tissue. Clip placement should be as close as
possible. There should not be more than 0.5 mm between clips (see illustration #7).
FAILURE TO COMPLETELY SQUEEZE THE LEVERS CAN RESULT IN CLIP MALFORMATION AND
POSSIBLE BLEEDING OR LEAKAGE.
6. Release the levers to disengage the clip from the AnastoClip GC applier and remove the clip
applier. (The closed clip is disengaged automatically from the jaws.) The applier automatically
advances the next clip for successive applications.
7. Check tightness of clip placement. Tissue should completely fill clip opening and clip should
not loosely rock side to side.
8. If desired, the clip can be removed with the AnastoClip Remover and a new clip can be placed
with the AnastoClip GC applier.
9. After completion of the anastomosis, one or more clips, and/or sutures, may be used to control
bleeding or leakage from the anastomotic site (if necessary.)
2
Closure System
Remover for the removal of any AnastoClip GC clips (if necessary).
®
Medium Large
4007-06 4007-07
C
B
A
Extra Large
4007-08
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