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FLOW COUPLER DEVICE AND SYSTEM

The marriage of two trusted technologies

The COUPLER and a 20 MHz ultrasonic Doppler.
The FLOW COUPLER DEVICE has been specifically designed for use in end-to-end anastomosis for the detection of blood flow in order to confirm vessel patency intra- and postoperatively at the anastomotic site.1

Rx Only. For safe and proper use of this device, refer to the Instructions for Use.

Please contact Customer Service for Instructions for Use (IFU). Call 800.510.3318 or email
    Early Intervention
    • Monitoring of the outflow vein of the flap will detect cessation of venous flow almost immediately1
    • Interruption of arterial flow will cause a near-immediate loss of the venous Doppler signal1
    Auditory Feedback
    • Loss of an audible signal alerts staff that a potential problem with perfusion exists1
    Safety and Efficiency
    • Reduce needless re-explorations1

INDICATIONS FOR USE:
The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

CONTRAINDICATIONS:

The FLOW COUPLER is not indicated for use in end-to-side anastomosis or for 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
    • Concurrent corticosteroid therapy

The FLOW COUPLER Device and System is contraindicated for use in the central circulatory system.

The MCA FLOW COUPLER Device and System
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The MCA FLOW COUPLER Monitor Device and System
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GEMflow monitor animation

For more information or to place an order please call Customer Service at 800.510.3318 USA or 205.941.0111

GEM2752-FC 2.0mm FLOW COUPLER with 20MHzDoppler
GEM2753-FC 2.5mm FLOW COUPLER with 20MHzDoppler
GEM2754-FC 3.0mm FLOW COUPLER with 20MHzDoppler
GEM2755-FC 3.5mm FLOW COUPLER with 20MHzDoppler
GEM2756-FC 4.0mm FLOW COUPLER with 20MHzDoppler
GEM1020M-2 FLOW COUPLER Monitor w/Power Cord
GEM1020PS-2 Power Supply Kit
GEM1003EXT-FC External Lead (Box of 4)

For more information or to place an order please call Customer Service at 800.510.3318 USA or 205.941.0111 or email

FLOW COUPLER Intra Op Doppler


Flow Coupler IFU


For more information or to place an order please call Customer Service at 800.510.3318 USA or 205.941.0111 or email

Reference:
1. Flow Coupler IFU. Synovis Micro Companies Alliance, Inc.
©Copyright 2020

USMP/MG219/15-0012(2)

SYNOVIS MICRO COMPANIES ALLIANCE, INC., A SUBSIDIARY OF BAXTER INTERNATIONAL INC. ALL RIGHTS RESERVED