2.
Description
The FLOW COUPLER System consists of a FLOW COUPLER Device and a FLOW COUPLER
Monitor. The FLOW COUPLER Monitor is apulsed Dopplerultrasound system designed
for the detection of blood ow in vessels. The FLOW COUPLER Device includes a20MHz
ultrasonic Dopplertransducer (probe) attached to one of the FLOW COUPLER rings, and an
external lead. The probe connects to the Monitor via the external lead and emits a pulsed
ultrasonic signal. An audible signal of varying volume strength is produced when the probe
detects ow.
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 vein 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-t onto one of the rings. Whenthe FLOW COUPLER Device is used in
conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to
detect bloodow and conrm vessel patency intra-operatively and post-operatively at the
anastomoticsite. Post-operatively, blood ow can be detected on an as-neededbasis for up
to 7 days. The FLOW COUPLER Doppler probe isnot intended to be apermanent implant
and shouldbe removed 3 to 14 days post-operatively.
Contraindications:
The FLOW COUPLER Monitor isnot intended specically to diagnose, monitor or correct a
defect of the heart or the central circulatory system.
WARNINGS:
• If procedures are not followed, injury may occur.
• Do notperform servicing and maintenance while the Monitor is in use. Severe device
damage may occur.
• FLOW COUPLER Monitor is not sterilizable. 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 insterile elds. Severe device damage may occur.
• Not for use in OXYGEN ENRICHED atmospheres to reduce re and explosion risk.
• Do not remove internal rechargeable lithium ion battery pack. Severe device damage
may occur. If required, return the Monitor to the manufacturer for the battery replacement.
• Monitor not suitable for use in the presence of a ammable anesthetic mixture with air
or with oxygen ornitrous oxide. Fire or explosion may occur.
CAUTIONS:
• If procedures are not followed, possible equipment or software damage may occur.
• The FLOW COUPLER System may be susceptible to picking up interference through the
coaxial cable that connects the probe to the Monitor. Do not use in the presence of any
highfrequency equipment, including highfrequency surgical generators.
• The FLOW COUPLER Monitor may turn o or lose LCD touch screenfunction due to
electrostatic discharge interference. Turn on the Monitor and Monitor’s function to
generate audible sounds and hardware control using buttons should not be impacted.
• Only use Monitor with FLOW COUPLER devices. Monitor may not function properly
and device damage may occur.
•
Only use FLOW COUPLER AC Power Supply included with the COUPLER Monitor (GEM1020M-2)
or Power Supply sold separately (GEM1020PS-2). Severe device damage may occur.
• During the use of all ultrasound devices, the operator shouldminimize the exposure of
ultrasound energy to the patient using the principle of ALARA (As Low As Reasonably
Achievable).
• No modication of this equipment is allowed. Severe device damage may occur.
• The FLOW COUPLER Monitor isintended for use by healthcare professionals only.
• The FLOW COUPLER Monitor and System may cause radio interference or may disrupt the
operation of nearbyequipment.
•
•
Avoid obstructing with the audio output from the speakers located on sides of the Monitor.
Audio volume and quality may be negatively aected.
Do not use any chemicals other than those listed within the cleaning instruction of this IFU
for cleaning of the Monitor. Severe device damage may occur.
• Avoid usage of the FLOW COUPLER Monitor adjacent to or stacked with other equipment
because it may result in inoperable Monitor. If such use is necessary, observe to verify
FLOW COUPLER Monitor and the other equipment are operating normally.
• Only use accessories (FLOW COUPLER Device and FLOW COUPLER Monitor Power Supply)
as specied in this Instruction For Use with the FLOW COUPLER Monitor because usage with
unspecied accessories may lead to increased electromagnetic emissions or decreased
electromagnetic immunity of the Monitor.
• Do not use portable RF communications equipment (including peripherals such as antenna
cables and external antennas) no closer than 30cm (12 inches) to any part of the FLOW
COUPLER Monitor and accessories (FLOW COUPLER Device and FLOW COUPLER Monitor
Power Supply). Otherwise, degradation of the performance of the Monitor may occur.
