Alvimedica Invader PTCA Instructions D'utilisation page 6

tested prior to packaging. Alvimedica shall exchange any product
with manufacturing or packaging defect(s) with a new one upon the
decision of a competent binding judicial authority. Due to biological
variations among individuals, no product is 100 % effective in every
case. Therefore, and since Alvimedica has no control over conditions
under which the product is used after sales, the selection of patients
and the methods of application. Alvimedica disclaims all warranties with
respect to the product, expressed or implied including, without limitation,
those of merchantability, and fitness for a particular purpose. Alvimedica
is not directly or indirectly responsible for any injury or damage to or loss
of any person resulting from the use of the product, nor is Alvimedica
responsible or liable, directly or indirectly, for any injury, damage or loss
that may result from re-use or re-sterilization.
LIMITATION OF LIABILITY
In no event shall Alvimedica be liable for any special, consequential,
indirect, collateral, incidental or punitive damages or lost profits or failure
to realize expected savings or other commercial or economic loss of
any kind, arising out of any breach of this IFU including breach of any
precautions, warnings and/or any recommendation mentioned herein.
INTELLECTUAL PROPERTY PROTECTION
All trademarks, logos, inventions, know-how, technology, proprietary
information and other intellectual property rights of this product belong
solely to Alvimedica. Alvimedica reserves all rights to demand, sue, seek
relief before judicial authorities in case of an infringement regarding any
unauthorized use or misuse of intellectual property or reverse engineering
related to the product.
INVADER™ PTCA balloon compliance table
* pressure (bar) | diameter (mm)
Note: Please refer to page 2
6
TÜRKÇE
TANIM
kateteridir. ALVIMEDICA INVADER™ PTCA Balon Dilatasyon Kateteri, koroner
Tablo 1.
Balon Minimum Nominal
(mm)
(mm) Uyumluluk ID'si (bar)
6, 10, 12, 5F (1.4 mm /
1.25 8
15, 20 0.056")
6, 10, 12, 5F (1.4 mm /
1.50 8
15, 20 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.00 8
20, 25 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.25 8
20, 25 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.50 8
20, 25, 30, 34 0.056")
6, 10, 12, 15, 5F (1.4 mm /
2.75 8
20, 25, 30, 34 0.056")
6, 10, 12, 15, 5F (1.4 mm /
3.00 8
20, 25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
3.25 8
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
3.50 8
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
3.75 8
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
4.00 8
25, 30, 34 0.056")
10, 12, 15, 20, 5F (1.4 mm /
4.50 8
25, 30, 34 0.056")
5F (1.4 mm /
5,00 10, 12, 15, 20 8
0.056")
> tekrarlayan semptomlar;
kontrendikedir:
UYARILAR / ÖNLEMLER
etmeyin.
Nominal
Patlama
16
16
16
16
16
16
16
16 • Koroner arter disseksiyonu
16
• Koroner arter trombozu
16
• Stabil olmayan anjina
• Akut miyokard enfarktüsü
16
• Dilate arterin tekrar stenozu
16
• Ventriküler fibrilasyon da dahil aritmiler
• Hemoraji ve hematom
16
• Hipertansiyon - hipotansiyon
• Enfeksiyon
-
• Emboli
• Ölüm
• Acil koroner arter baypas graft cerrahisi
-
-