LeMaitre AnastoClip GC Instructions D'utilisation page 2

AnastoClip GC® Closure System
(Model Numbers 4009-06, 4009-07, 4009-08, 4011-01, 4011-02, 4011-03)
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 closure of arteriotomies and veinotomies, the attachment
of synthetic vascular prostheses, and the creation of everting anastomoses in blood vessels and other
small tubular structures. The Applier is also intended for approximation of dural tissue (dural approxi-
mation only available in the European Union).
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. They are available in two (2) lengths: 3 in. distal shaft and 6 in. distal shaft.
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 Remover for the removal of any AnastoClip GC clips (if necessary).
®
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 maxi-
mum 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
6" (15.2 cm) Shaft
How Supplied:
The applier is supplied sterile. The sterility of the device is assured as long as the packaging is not
opened or damaged.
The entire device is considered to be non-pyrogenic for vascular applications.
The implantable clips, the stainless steel shaft and jaws of the applier are
considered to be non-pyrogenic for dura applications. The plastic part of the
applier (handle, levers and rotation knob) should not be in contact with cerebral
spinal fluid.
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
Medium Large
4009-06 4009-07
4011-01 4011-02
C
B
A
Extra Large
4009-08
4011-03
1
G
1
G
I
I
2
D
E
1
G
1
H G
I
H
J
I
2
J
2
4
5
F
H
H
J
4
4