On-X
®
Ascending Aortic Prosthesis IFU
Table 2. Definitions
EC REP
Authorized representative in
the European community
Do not use if
package is damaged
Manufacturer
Do not re-use
Consult instructions
for use
Use-by date
www.onxlti.com/ifu/AAP
Consult instructions
for use
SN
Serial number
REF
Catalogue number
Date of manufacture
STERILE EO
Sterilized using
Ethylene Oxide
Do not resterilize
MR conditional
Temperature limitation
Federal Law (USA) restricts
this device to sale by or on the
order of a physician.
Product must be used within
24 hours of opening foil
pouch.
Graft Diameter in millimeters
Do not discard
Caution, consult
accompanying documents
SZ mm
Valve Size in millimeters
The On-X Prosthetic Heart Valve was determined to be MR-conditional
Materials International, Designation: F2503-08. See
www.onxlti.com/onxlti-hvm-mri-memo-3-0-tesla-march-2010.html for more
information.
446
Summary of Contents for Ascending Aortic Prosthesis
Page 23: ...On X 6 in situ On X 5 93 42 I 13 6h AAP 6...
Page 29: ...On X 12 3 8 9 6 19 Gelweave Valsalva Vascular Prosthesis 5 9 7 On X LTI...
Page 32: ...On X 15 12 On X LTI On X LTI On X LTI On X LTI On X LTI On X LTI On XLTI...
Page 152: ...On X 2 442 1 On X 442 2 On X 442 3 443 4 443 5 443 6 443 7 443 8 444 1 On X mm 445 2 446...
Page 155: ...On X 5 On X On X LTI 19 mm 25 mm 27 29 mm 4 2 On X On X 19 Gelweave Valsalva 5 On X 5...
Page 156: ...On X 6 93 42 I 13 6 AAP 6 6 1 On X 7...
Page 161: ...On X 11 19 mm 25 mm 19 mm 25 mm 19 mm 25 mm 27 29 mm 9 5 3 8 9 6 19 GelweaveValsalva 5...
Page 164: ...On X 14 12 On X LTI On X LTI On X LTI On X LTI On X LTI On X LTI On X LTI...
Page 199: ...On X Ascending Aortic Prosthesis IFU 6 Gelweave Valsalva 5 On X 5 93 42 EEC I 13 6h AAP...
Page 210: ...On X IFU 2 442 1 On X 442 2 On X 442 3 443 4 443 5 443 6 443 7 443 8 444 1 On X mm 445 2 446...
Page 214: ...On X IFU 6 On X 5 13 6h I 93 42 EEC AAP 6 6 1 On X...
Page 220: ...On X IFU 12 3 8 9 6 19 Gelweave Valsalva 5 9 7 On X LTI...
Page 271: ...On X IFU 5 On X On X On X On X LTI On X On X LTI On X On X LTI 25 19 27 29 4 2 On X On X 19...
Page 272: ...IFU On X 6 Gelweave Valsalva 5 On X 5 93 42 EEC 13 6h AAP...
Page 273: ...On X IFU 7 6 6 1 On X 7 8 8 1 SZ 27 29 25 23 21 19 On X mm 1 8 2 On X 2...
Page 278: ...IFU On X 12 25 19 25 19 25 19 27 29 9 5 3 8 9 6 19 Gelweave Valsalva 5...
Page 281: ...On X IFU 15 On X LTI 11 2 12 On X LTI On X LTI On X LTI On X LTI On X LTI On X LTI...
Page 327: ...On X 2 442 1 On X 442 2 On X 442 3 443 4 443 5 443 6 443 7 443 8 444 1 On X 445 2 446...
Page 331: ...On X 6 5 93 42 EEC I 13 6h AAP 6 6 1 On X...
Page 332: ...On X 7 7 8 8 1 On X 19 21 23 25 27 29 SZ mm 1 8 2 On X 2 8 3 On X Tyvek On XLTI 2 1 2 On X...
Page 336: ...On X 11 12 9 4 On X On X 19 25 27 29 19 25 19 25 19 25 27 29 9 5 3 8 9 6...
Page 337: ...On X 12 19 GelweaveValsalva 5 9 7 On X LTI On X 9 8 On X On X...
Page 341: ...On X 2 442 1 On X 442 2 On X 442 3 443 4 443 5 443 6 443 7 443 8 444 1 On X mm 445 2 446...
Page 345: ...On X 6 On X 5 93 42 I 13 6 AAP 6 6 1 On X...
Page 346: ...On X 7 7 8 8 1 On X 19 21 23 25 27 29 mm SZ mm 1 8 2 On X 2 8 3 On X Tyvek On X LTI 2 1 2...
Page 351: ...On X 12 3 8 9 6 19 Gelweave Valsalva 5 9 7 On X...
Page 354: ...On X 15 12 On X LTI On X LTI On X LTI On X LTI On X LTI On X LTI On X LTI...
Page 430: ...On X 2 442 1 On X 442 2 On X 442 3 443 4 443 5 443 6 443 7 443 8 444 1 On X 445 2 446...
Page 433: ...On X 5 19 25 27 29 4 2 On X On X 19 C Gelweave Valsalva 5 in situ On X 5...
Page 434: ...On X 6 93 42 EEC I 13 6h 6 6 1 On X 7 8 8 1 On X 19 21 23 25 27 29 SZ mm 1 8 2 On X 2...
Page 439: ...On X 11 9 6 19 C Gelweave Valsalva 5 9 7 On X in situ in situ On X 9 8 On X On X...
Page 444: ...On X Ascending Aortic Prosthesis IFU Figure 8 Removing Holder Handle from Prosthesis 444...
