GEM COUPLER Instructions D'utilisation page 7

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Made in the U.S.A.
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DESCRIPTION:
The Synovis MCA GEM Microvascular Anastomotic COUPLER
Device and System have been specifically designed for use in the
anastomosis of blood vessels.
The GEM Microvascular Anastomotic COUPLER Device
rings are made of polyethylene and surgical grade stainless steel
pins. A protective cover and jaw assembly protect the rings and
allow for easy loading onto the Anastomotic Instrument. Both
the protective cover and jaw assembly are disposable. The GEM
Microvascular Anastomotic COUPLER Device is single-use and
available in various sizes.
The GEM Microvascular Anastomotic COUPLER System
consists of a reusable Anastomotic Instrument (surgical-grade
stainless steel and titanium), reusable COUPLER Forceps
(surgical-grade stainless steel), a reusable Double-Ended
Vessel Measuring Gauge (surgical-grade stainless steel),
and a Sterilization Tray (anodized aluminum). The GEM
Microvascular Anastomotic COUPLER System is available as a
Graphic Graphic Meaning
complete system or as single items.
Size of the GEM
INDICATIONS FOR USE:
COUPLER
Device (inner The GEM Microvascular Anastomotic COUPLER Device is
diameter of the
intended to be used in the anastomosis of veins and arteries
COUPLER rings)
normally encountered in microsurgical procedures only in the
peripheral vascular system.
The GEM Microvascular Anastomotic COUPLER Device
is intended for use with veins and arteries having an outside
diameter no smaller than 0.8 mm and no larger than 4.3 mm and
a wall thickness of 0.5 mm or less. The degree of vessel spasm and
the elasticity of the vessel should be considered when choosing the
COUPLER Device size to be used. Use a GEM Vessel Measuring
Gauge to approximate the OUTER diameter of the vessel for
selection of an appropriate COUPLER Device size.
NOTE: Approximate the vessel to an appropriate COUPLER
size using a GEM Vessel Measuring Gauge. In an end-to-end
anastomosis, the two vessel ends should be approximately the
same size as the inside diameter of the COUPLER Device being
used. In an end-to-side anastomosis, the opening made to the
side vessel should be approximately the same size as the inside
diameter of the COUPLER Device being used. If the end vessel
size is outside of the specified range, do not use the COUPLER
Device to mate the vessels.
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