GEM FLOW COUPLER Mode D'emploi page 9

• 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 FLOW COUPLER Device should only be used with the GEM FLOW COUPLER
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
FLOW COUPLER rings have been evaluated with a 1.5 Tesla and 3.0 Tesla magnetic field and
no change in displacement was observed in each of three orthogonal planes.
pins in the FLOW COUPLER Devices 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).
• 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
FLOW COUPLER Device 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 FLOW COUPLER Device. The degree
of vessel spasm and the elasticity of the vessel should be considered when choosing the
FLOW COUPLER Device size to be used.
2. Select the appropriate size FLOW COUPLER Device. Both vessel ends should be approximately
the same size as the inside diameter of the FLOW COUPLER Device being selected.
3. Remove the lid from the outer tray and aseptically remove the inner tray; the inner tray may
be placed in the sterile field. Inspect the inner tray. Do not use if the inner tray is damaged or
if the seals are not intact. Remove the lid from the inner tray.
4. Turn the Anastomotic Instrument knob fully counterclockwise, and then insert the
FLOW COUPLER Device onto the Anastomotic Instrument while FLOW COUPLER
Device is still in tray. The matching indicator arrows on the FLOW COUPLER Device
and the Anastomotic Instrument should be pointing toward each other when loading
(See Figures 2 & 3). Ensure that an audible click is heard for proper loading.
5. Remove FLOW COUPLER Device from tray and protective cover, being careful not to pull
the wire (See Figure 4).
6. Verify probe function by connecting probe to Monitor and irrigating attached probe tip with
sterile saline. (Refer to the Flow Detection section of these Instructions for Use for proper
connection instructions.) An audible signal from the Monitor verifies proper function of the
The stainless steel
1, 3 device. If no signal is identified, refer to the Troubleshooting section of these Instructions for
Use.
7. Visually inspect to see that both rings are seated at the bottom of the U portion of the jaw
(See Figures 5a & 5b) and the pins are not bent. If pins are bent, do not attempt to straighten.
Instead use a new FLOW COUPLER Device.
NOTE: To avoid unwanted kinking or twisting of the vessel during positioning of the flap,
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.
8. Place the Anastomotic Instrument perpendicular to the vessel(s), with the FLOW COUPLER
jaw assembly near the two vessel ends. Pull one vessel end through one of the
FLOW COUPLER rings using microsurgical forceps (See Figure 6).
Care should be taken to avoid twisting of the vessel.
9. Take a bite of approximately one to two pin diameters of the vessel wall and intimal lining,
evert 90 degrees and impale onto one pin. Proceeding in a triangular fashion, impale the
vessel firmly upon every other pin, completing three pins (See Figure 7). Complete vessel
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