Radi FemoSeal 11202 Manual page 8

8. verify hemostasis.
Warning: If there is persistent arterial bleeding from the incision site, do
not cut the multifilament until hemostasis is achieved. If hemostasis is not
achieved, fasten the multifilament with a sterile wound dressing and apply
supplementary compression until hemostasis is achieved. In the case of
persistent arterial bleeding, significant bleeding complications may occur
which could result in patient injury or death.
9. Cut the multifilament below skin level using a sterile instrument (see
figure 9).
Storage, packaging and disposal
· Sterile and non­pyrogenic in unopened and undamaged package.
· FemoSeal vascular Closure System should be stored in a cold location
®
(room temperature not exceeding 25 °C).
· FemoSeal vascular Closure System contains resorbable materials that
®
degrade by exposure to heat and moisture; therefore, the device may not be
resterilized.
· Dispose of contaminated units, components, and packaging materials utilizing
standard hospital procedures and universal precautions for biohazardous
waste.
Patents
EP 1 147 743, EP 1 169 968, EP 1 222 896, EP 1 244 725, EP 1 254 634,
EP 1 266 626, EP 1 269 919, EP 1 543 781, SE 526 209, US 6,425,911, US
6,508,828, US 6,596,012, US 6,682,489, US 6,712,837, US 6,929,655
US 7,044,916, US 7,285,097, JP 3844661, JP 3860067, JP 4159805, JP
4233256
Radi Medical Systems aB
Palmbladsgatan 10
Box 6350, 754 50 Uppsala, SWEDEN
+46 (0) 18 16 10 00
www.radi.se
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