Symbol Definitions; Indications For Use - GEM FlowCOUPLER Instrucciones De Uso

SYMBOL DEFINITIONS:

The following symbols and definitions pertain only to the GEM FlowCOUPLER Device:
Size of the GEM FlowCOUPLER Device
(inner diameter of the FlowCOUPLER rings)
Consult instructions for use
Do not reuse
Use by Date
Sterilized using ethylene oxide
EO
Do not use if the product sterilization barrier or its packaging is compromised.
The following symbols and definitions pertain to the GEM FlowCOUPLER Device and System:
Attention, consult accompanying documents.
This product and package is not made with natural rubber latex.
Made in the U.S.A.
Content
CAUTION: Federal (USA) Law restricts this device to sale by or on the order
of a physician.
Type CF Applied Part
RF Transmitter
Direct current
Catalog number
Lot number
Part number
Tracking number
Manufacturer
Authorized Representative in the European Community
Refer to instruction booklet (symbol white on blue)
DESCRIPTION:
The Synovis MCA GEM FlowCOUPLER
TM
designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at
the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days.
The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER
Monitor. The FlowCOUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe)
attached to one of the FlowCOUPLER rings, and an external lead. The FlowCOUPLER rings
are made of high density polyethylene and surgical grade stainless steel pins. A protective cover
and jaw assembly protect the rings and probe which allow for easy loading onto the Anastomotic
Instrument. Both the protective cover and jaw assembly are disposable.
Accessories to the FlowCOUPLER System include a reusable Anastomotic Instrument (surgical-
grade stainless steel and titanium), a reusable Vessel Measuring Gauge (surgical-grade stainless
steel), COUPLER Forceps (surgical-grade stainless steel), and a Sterilization Tray (anodized
aluminum).

INDICATIONS FOR USE:

The FlowCOUPLER 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 FlowCOUPLER 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 FlowCOUPLER Device is used in conjunction with the FlowCOUPLER
Monitor, the FlowCOUPLER 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 FlowCOUPLER Doppler probe is not
intended to be a permanent implant and should be removed 3 to 14 days post-operatively.
CONTRAINDICATIONS:
The FlowCOUPLER 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, or
• Concurrent corticosteroid therapy
The FlowCOUPLER Device and System is contraindicated for use in the central circulatory
system.
7
Device and System have been specifically
®