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SYMBOL DEFINITIONS:
Attention, consult accompanying documents
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
Date of Manufacture
Serial number
Catalog number
Batch code
Part number
Manufacturer
Authorized representative in the European Community
Refer to instruction booklet (symbol white on blue)
DESCRIPTION:
The Synovis MCA GEM FlowCOUPLER
FlowCOUPLER Monitor. The FlowCOUPLER Monitor is a pulsed Doppler ultrasound system
designed for the detection of blood flow in vessels. The FlowCOUPLER includes a 20MHz
ultrasonic Doppler transducer (probe) attached to one of the FlowCOUPLER rings, and an external
lead. The probe via the external lead connects to the monitor and emits a pulsed ultrasonic signal. A
varying audible signal is produced when the probe detects flow.
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 device and system is contraindicated for use in the central circulatory system.
WARNINGS:
If procedures are not followed, injury may occur.
Never sterilize the FlowCOUPLER Monitor with autoclave, ultraviolet, gamma radiation, gas,
steam, or heat sterilization techniques. Severe device damage and/or injury may occur.
The Monitor should not contact mucus membranes, blood, or compromised tissue, and is not used in
sterile fields.
Not for use in OXYGEN ENRICHED atmospheres.
Do not install batteries backwards, charge, or mix with other battery types. Remove batteries during
prolonged storage. Batteries may explode or leak causing injury. Replace all batteries at the same
time. Properly dispose of batteries according to local regulations. Do not incinerate.
3
®
System consists of a FlowCOUPLER and a
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