Instructions For Use - GEM FlowCOUPLER Instrucciones De Uso

WARNINGS:
• Failure to use the Vessel Measuring Gauge to approximate the vessel size could result in using
a FlowCOUPLER 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 FlowCOUPLER 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 FlowCOUPLER is supplied sterile and is single use only. Do not resterilize or reuse the
FlowCOUPLER.
- 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 FlowCOUPLER 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 FlowCOUPLER for the anastomosis of tubular structures other than veins and
arteries has not been established.
• Safe use of the FlowCOUPLER for the anastomosis of growing vessels in children or
adolescents has not been established. Not intended for fetal use.
• Safe use of the probe portion of the FlowCOUPLER during MRI procedures has not been
established. Therefore the probe should be removed prior to a MRI procedure.
• Security of an anastomosis utilizing FlowCOUPLERs 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 FlowCOUPLER utilized.
• Ensure that suture sleeve and connectors are not implanted.
• 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 thoroughly inspected before use. Instruments that are damaged and/or in need
of repair should not be used.
CAUTIONS:
• Use of the FlowCOUPLER involves potential risks normally associated with any implanted
device, e.g., infection, perforation, or laceration of vessels, erosion, implant rejection, or device
dislodgement/migration.
• The angle of the probe wire relative to the flap will be influenced by the orientation of the
Anastomotic Instrument during formation of the anastomosis. To avoid unwanted kinking or
twisting of the vessel during positioning of the flap-which may result in poor flap perfusion-
care should be taken to establish the desired angle of the probe wire relative to the flap and
to adjust the Anastomotic Instrument accordingly prior to starting the anastomosis.
• Should a probe be prematurely removed from the probe-holder, do not attempt to re-insert
the probe into the probe-holder. Instead remove rings and implant a new FlowCOUPLER
Device.
• Probe wire is delicate. The use of crushing forceps may damage the probe wire.
• Use caution when manipulating the probe wire. Sharp bends may cause damage to the
probe wire.
• The use of clamps on the external lead wire may damage the external lead.
• The probe is not intended to be a permanent implant and should be removed 3 to 14 days post-
operatively.
• Avoid excessive force to remove the probe from the patient, which may cause injury to the
blood vessel. If the probe can not be removed using gentle traction, the probe should be
surgically removed. Do not cut the probe wire.
• Assure that the probe is attached to the probe wire upon removal of the probe. If not, surgical
removal of the probe is required.
• The FlowCOUPLER should only be used with the GEM FlowCOUPLER Monitor.
• During the use of all ultrasound devices, the operator should minimize the exposure of
ultrasound energy to the patient using the principle of ALARA (As Low As Reasonably
Achievable).

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 FlowCOUPLERs have been evaluated with a 1.5 Tesla magnetic field and no change
in displacement was observed in each of three orthogonal planes.¹ The stainless steel pins
in the FlowCOUPLERs are nominally nonferromagnetic. However, the US Food and Drug
Administration (FDA) has made 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).
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