GEM COUPLER Instructions D'utilisation page 9

thoroughly inspected before use. Instruments that are damaged
and/or in need of repair should not be used.
• When performing an end-to-side anastomosis with this
COUPLER device, the lumen of the "side" vessel is narrowed
slightly. For this reason, the diameter of the "side" vessel
should be larger than that of the "end" vessel when completing
such a procedure. The opening made to the side vessel should
be approximately the same size as the inside diameter of the
COUPLER device being used.
CAUTIONS:
• Use of the COUPLER Device involves potential risks normally
associated with any implanted device, e.g., infection, perforation,
or laceration of vessels, erosion, implant rejection, or device
dislodgement/migration.
INSTRUCTIONS FOR USE:
These Instructions for Use are designed for proper use of this
device. They are not intended to serve as a reference to surgical
technique, to supersede institutional protocols or professional
clinical judgment regarding patient care.
It is the responsibility of the clinician to inform the patient that
he/she is the recipient of permanent implants which contain metal
components (surgical-grade stainless steel pins). The COUPLER
Device rings have been evaluated with a 1.5 Tesla and a 3.0 Tesla
magnetic field and no change in displacement was observed in
each of three orthogonal planes.
1, 3
COUPLER Devices are nominally nonferromagnetic. However,
the US Food and Drug Administration (FDA) has made
The stainless steel pins in the
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recommendations for any medical device implanted which have
metallic components to include:
• Documentation in the official medical record of the identity
of the implant (manufacturer, model number, lot and serial
numbers, and identifying marks, if any).
• Documentation of the technique and results of any magnetic
testing performed on the implant or that no such testing was
done.
• Patient education regarding the particular implant and
recommendation for identifying medical alert card, bracelet, or
necklace characterizing the implanted device.²
3.0mm COUPLER Size or Smaller:
End-to-End Anastomosis:
Using conventional microsurgical technique, mobilize a
minimum of 1 cm of each vessel end. Using vascular clamps,
clamp off the vessel(s) and irrigate the vessel openings. The
COUPLER requires a greater amount of free vessel within the
clamps than a conventional suture repair.
1. After gentle dilation, estimate the outer diameter of each vessel
using the Vessel Measuring Gauge. The circular guides on the
gauge should not be placed inside the vessel lumen (See
Figure 1). If there is a size discrepancy between the two
vessels, use the measurement of the smaller vessel to choose the
appropriate COUPLER Device. The degree of vessel spasm
and the elasticity of the vessel should be considered when
choosing the COUPLER Device size to be used.
EN