Getinge MAQUET HEARTSTRING III Instrucciones De Uso página 9

HEARTSTRING III Proximal Seal System
Finger
Loosened
Stitches
9.7 Visually confirm the complete removal of the HEARTSTRING III Proximal Seal by the presence of
an angled cut at the end of the unraveled Seal.
9.7.1 Carefully apply tension to the free ends of the suture to draw closed the loosened stitches and attain a
hemostatic anastomosis. Complete the anastomosis per standard surgical procedure.
10. The Aortic Cutter is a single use (one aortotomy) device; however, if performing multiple anastomoses with
an Aortic Cutter or Aortic Punch that is indicated to do so:
10.1 Select an anastomosis site at least 1.5 cm apart from the previous anastomosis.
10.2 Remove excised aortic tissue from punch.
10.3 Repeat steps 2-8.
HOW SUPPLIED
The HEARTSTRING III Proximal Seal System is available in two configurations:
1. 5-Pack HEARTSTRING III Proximal Seal: One (1) 5-pack includes five (5) individual packages of
one (1) Proximal Seal and one (1) Delivery Device and one (1) Loader Device.
2. HEARTSTRING III Proximal Seal System: One (1) Proximal Seal, one (1) Loader Device, one (1)Delivery
Device, and one (1) Aortic Cutter.
The HEARTSTRING III Proximal Seal System is supplied STERILE and NON-PYROGENIC in an unopened
and undamaged package. It has been sterilized using gamma irradiation and is for single use only. DO NOT
RESTERILIZE. DO NOT REUSE.
CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.
There are no latex components in the HEARTSTRING III Proximal Seal System.
WARRANTY
MAQUET Cardiovascular (MCV) warrants that reasonable care has been used in the design and manufacture of
this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein,
whether express or implied by operation of law or otherwise, including, but not limited to, any implied
warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization
of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and
other matters beyond MCV's control directly affect the instrument and the results obtained from its use. MCV's
obligation under this warranty is limited to the repair or replacement of this instrument and MCV shall not be
liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this
instrument. MCV neither assumes, nor authorizes any other person to assume for it, any other or additional liability
or responsibility in connection with this instrument. MCV assumes no liability with respect to instruments
reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited to
merchantability or fitness for a particular purpose, with respect to such instruments.
Figure 21.
Applying Index Finger to Control Bleeding
ENGLISH
HEARTSTRING III
Proximal Seal
(partially unraveled)
Vessel Graft
9