LeMaitre AnastoClip GC Instructions D'utilisation page 2

AnastoClip® AC Closure System
(Model Numbers e4000-05, e4000-06, e4000-07, e4000-08)
English — Instructions for Use
IMPORTANT!
This booklet is designed to assist in using the AnastoClip® AC with titanium clips. It is not a reference
to surgical stapling techniques.
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
Indications
The AnastoClip applier has application in the repair of arteriovenous fi stulae 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 approximation is cleared only in the United
States, the European Union and New Zealand). Dural approximation is not cleared for Small appliers
(e4000-05).
Eff ects
The AnastoClip applier is available in four (4) clip sizes: small-0.9 mm, medium-1.4 mm, large-2.0
mm and extra large-3.0 mm. The AnastoClip applier is also available in two (2) lengths: 2 in distal
shaft and 3 in. distal shaft. The AnastoClip AC clip 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 clips (if necessary).
MR Compatibility
Non-clinical testing demonstrated that the AnastoClip AC Closure System is MR Conditional. A patient
with this device can be scanned safely in an MR system under the following conditions:
Static magnetic fi eld of 1.5-Tesla and 3-Tesla, only.
Maximum spatial gradient magnetic fi eld of 2,000-Gauss/cm (20-T/m).
Maximum MR system reported, whole body averaged specifi c 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 defi ned, the AnastoClip AC 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 AC 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 (Table 1):
AnastoClip Applier Small
2" (5 cm) Shaft e4000-05
3" (7.6 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 fl uid.
Instructions For Use
NOTE: It is recommended to wear loupes. A 2.5X magnifi cation 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.
D
C
B
A
Extra
Medium Large
Large
e4000-06 e4000-07 e4000-08
2
F
E
G
H
I
J