GEM FLOW COUPLER Mode D'emploi page 7

SYMBOL GLOSSARY PER US FD&C ACT:
Standard Symbol Symbol Title
The following symbols and definitions pertain to the GEM FLOW COUPLER Device:
ISO-15223-1* Consult instructions for use
ISO-15223-1 Do not reuse
ISO-15223-1 Use by Date
Sterilized using ethylene
ISO-15223-1
EO
oxide
Do not use if package is
ISO-15223-1
damaged
The following symbols and definitions pertain to the GEM FLOW COUPLER Device and System:
ISO-15223-1 Caution
IEC 60417
IEC 60417
ISO-15223-1 Catalog number
ISO-15223-1 Batch code
ISO-15223-1 Manufacturer
Authorized Representative
ISO-15223-1
in the European Community
Symbol
Symbol Meaning
Number
Consult instructions for use 5.4.3
Do not reuse 5.4.2
Use by Date 5.1.4
Sterilized using ethylene oxide 5.2.3
Do not use if the product sterilization
barrier or its packaging is compromised 5.2.8
Attention, consult accompanying
5.1.5
documents.
This product and package is not made
with natural rubber latex.
Content
CAUTION: Federal (USA) Law restricts
this device to sale by or on the order of
a physician.
Type CF Applied Part 5355
RF Transmitter
Direct current 5031
Catalog number 5.1.6
Lot number 5.1.5
Manufacturer 5.1.1
Authorized Representative in the
5.1.2
European Community
Standard Symbol Symbol Title
ISO 7010
ISO-15223-1 Do not re-sterilize
ISO-15223-1 Date of manufacture
*ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied –
Part 1: General requirements
Additional symbols and graphics on the product labeling that are not required by the
US FD&C Act:
Symbol Symbol Description
Made in the U.S.A.
Manufacturer part number
Internal tracking number
DESCRIPTION:
The Synovis MCA GEM FLOW COUPLER Device and System have been specifically
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 FLOW COUPLER System consists of a FLOW COUPLER Device and a FLOW COUPLER
Monitor. The FLOW COUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe)
attached to one of the FLOW COUPLER rings, and an external lead. The FLOW COUPLER 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 FLOW COUPLER 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).
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Symbol
Symbol Meaning
Number
Refer to instruction booklet (symbol
M002
white on blue)
Do not re-sterilize 5.2.6
Date of manufacture 5.1.3
Graphic Graphic Meaning
Size of the GEM FLOW
COUPLER Device
(inner diameter of the FLOW
COUPLER rings)
EN