Terumo Angio-Seal VIP Скачать руководство пользователя страница 4

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CLINICAL TRIALS

Safety and Effectiveness Study

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clinically indicated for a diagnostic or an interventional cardiac procedure involving access through the femoral artery using an 8F sheath or smaller for the 8F Angio-Seal or a 6F sheath 

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Effectiveness Results 

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Table 2: Time to Hemostasis

Time to Hemostasis

(minutes)

Diagnostic 

Patients (n = 97)

8F Interventional 

Patients (n = 105)*

6F Interventional 

Patients (n = 103)

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Range

“

0-10

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Distribution

t = 0




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Table 3: Time to Ambulation

Time to Ambulation

(hours)

Diagnostic

 (n = 92)

8F Interventional 

(n = 98)

6F Interventional 

(n = 99)

0HDQ“6'

Range

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“

“

Distribution*






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Early Ambulation and Discharge Study in 6F Diagnostic Patients 

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Methods:

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Содержание Angio-Seal VIP

Страница 1: ...INSTRUCTIONS FOR USE Angio Seal VIP Vascular Closure Device 610130 610131...

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Страница 5: ...120 Endpoint Study Patients 0DMRU FRPSOLFDWLRQV 1 Q VWDWLVWLF S YDOXH Minor complications 1 Conclusions 5HVXOWV RI WKH FOLQLFDO VWXG GHPRQVWUDWH WKDW SDWLHQWV WKDW KDYH XQGHUJRQH GLDJQRVWLF DQJLRJUDS...

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Страница 7: ...should not move into or out of the artery for the remainder of the Angio Seal device deployment procedure Using the sheath markings as a guide ensure that the sheath position has not changed If re ad...

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Страница 10: ...UHYHDOHG Fig 15 Fig 16 NOTE The black compaction marker is usually exposed If not repeat step C 4 Sufficient resistance will indicate completion of sealing and the black compaction marker will usuall...

Страница 11: ...orbable it must be removed NOTE Make sure the suture retracts below skin level to avoid infection NOTE If seeping of blood occurs after placing the Angio Seal Device or after removing the tamper tube...

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