Symbol Definitions; Indications For Use - GEM Synovis FLOW COUPLER GEM1020M Manual

MS-12854C IfU, fLOW COUPLER Monitor:Layout 1 9/15/2010 4:23 PM Page 3

SYMBOL DEFINITIONS:

Consult Instructions for Use
Made in the U.S.A.
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
Date of Manufacture
Serial number
REf
Catalog number
LOT
Batch code
Part number
SSI internal code
DESCRIPTION:
The Synovis MCA GEM FLOW COUPLER
COUPLER Monitor. The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for
the detection of blood flow in vessels. The FLOW COUPLER includes a 20MHz ultrasonic Doppler
transducer (probe) attached to one of the FLOW COUPLER 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.
System consists of a Flow Coupler and a FLOW
®

INDICATIONS FOR USE:

The FLOW COUPLERDevice 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 Monitor is not intended specifically to diagnose, monitor or correct a defect
of the heart or the central circulatory system.
WARNINGS:
If procedures are not followed, injury may occur.
Never sterilize the FLOW COUPLER 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.
Monitor not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or
nitrous oxide.
Not intended for fetal use.
CAUTIONS:
If procedures are not followed, possible equipment or software damage may occur.
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