GEM COUPLER Instructions D'utilisation page 8

CONTRAINDICATIONS:
The COUPLER Device is not indicated for use in patients
presenting conditions that would normally preclude
microvascular repair with suture technique. Examples of such
conditions include, but are not limited to:
• Pre-existing or suspected peripheral vascular disease,
• Ongoing irradiation of the area of reconstruction,
• Clinical infection of the area of reconstruction,
• Anticipated infection due to significant contamination of the
area of reconstruction,
• Friability of the vascular tissue due to sclerotic conditions,
• Concurrent diabetes mellitus, or
• Concurrent corticosteroid therapy
WARNINGS:
• Failure to use the Vessel Measuring Gauge to approximate
the vessel size could result in using a COUPLER Device of
an inappropriate size. Using a ring too large for the vessel
may result in stressing or tearing of the vessel wall and a
compromised anastomosis. Using a ring too small for the vessel
may unduly constrict the vessel and lead to thrombosis or ring
separation.
• Failure to squeeze the COUPLER jaws with a hemostat or
similar instrument prior to ejection of the joined rings may
result in an inadequate friction fit and possible ring separation.
Inspect the anastomotic site to ensure that the anastomosis has
been satisfactorily completed.
• The COUPLER Device is supplied sterile and is single use only.
Do not resterilize or reuse the COUPLER Device.
- Resterilization may compromise the structural integrity of the
product which may lead to incomplete anastomosis.
- Device cannot be reused due to possible structural damage
during first use which may lead to incomplete anastomosis.
• Do not use the COUPLER Device if the package has been
opened or appears to be damaged or compromised as sterility
may be compromised. Failure to observe this warning may
result in surgical infection.
• Safe use of the COUPLER Device for the anastomosis of
tubular structures other than veins and arteries has not been
established.
• Safe use of the COUPLER Device for the anastomosis of
growing vessels in children or adolescents has not been
established. Not intended for fetal use.
• Security of an anastomosis utilizing COUPLER Devices that
have been approximated, reopened, and then reapproximated
has not been demonstrated. When reapproximation of the
anastomosis is desired, the vessel should be removed from each
ring and a new COUPLER Device utilized.
• The Anastomotic Instrument, Vessel Measuring Gauge,
COUPLER Forceps, and Sterilization Tray must be sterilized
prior to use.
• The Anastomotic Instrument, Vessel Measuring Gauge,
COUPLER Forceps, and Sterilization Tray should be
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