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Fig. 8

NOTE: If significant resistance to carrier tube advancement is encountered when insertion is almost complete, the anchor may be impinging on the posterior wall of 
the artery. DO NOT CONTINUE TO ATTEMPT TO ADVANCE. In this case, slight repositioning of the sheath, either by reducing the angle of the sheath with respect to 
the skin surface or by pulling the sheath back by 1-2 mm, may permit normal deployment.

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Fig. 9 (Correct)

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NOTE: If the device sleeve separates from the sheath while attempting full rear lock positioning, do not push the Angio-Seal™ device forward to reattach the sheath 
cap. Complete sealing of the puncture following instructions in C-1.

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Fig. 10

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The Distal end of device cap completely covers the colored indicator band

 

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Fig. 11 (Incorrect)

NOTE:  Do not proceed until you are certain that the anchor has been properly deployed (Figure 9). If the anchor is improperly deployed, the Angio-Seal device will 
not function.

Summary of Contents for Angio-Seal VIP

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

Page 2: ...PV RI GLVWDO DUWHULDO LQVXIILFLHQF R QRW XVH WKH QJLR 6HDO GHYLFH LI WKH SXQFWXUH VLWH LV SUR LPDO WR WKH LQJXLQDO OLJDPHQW DV WKLV PD UHVXOW LQ D UHWURSHULWRQHDO KHPDWRPD PRECAUTIONS Special Patient...

Page 3: ...DOO DEVRUEDEOH FRPSRQHQWV KDYH EHHQ ZLWKGUDZQ QFKRU IUDFWXUH RU HPEROLVP DPLQH GHYLFH WR GHWHUPLQH LI DQFKRU KDV EHHQ ZLWKGUDZQ I EOHHGLQJ RFFXUV DSSO PDQXDO RU PHFKDQLFDO SUHVVXUH WR WKH SXQFWXUH VL...

Page 4: ...WLPH IURP GHYLFH GHSOR PHQW WR WKH WLPH WKH SDWLHQW ZDONHG IRU YH PLQXWHV RU IHHW 0DMRU DQG RYHUDOO FRPSOLFDWLRQ UDWHV FRPSULVHG WKH VDIHW HQGSRLQWV PDMRU FRPSOLFDWLRQ ZDV GH QHG DV VXUJLFDO YDVFXODU...

Page 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...

Page 6: ...H LQVHUWLRQ VKHDWK LV IDFLQJ XS LQVHUW WKH DVVHPEO LQWR WKH SXQFWXUH WUDFW KHQ WKH WLS RI WKH LQVHUWLRQ VKHDWK LV DERXW FP LQWR WKH DUWHU EORRG ZLOO EHJLQ WR IORZ IURP WKH GULS KROH LQ WKH ORFDWRU LJX...

Page 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...

Page 8: ...LV SXOOHG RXW IURP UHDU KROGLQJ SRVLWLRQ RQWLQXH SXOOLQJ RQ WKH GHYLFH FDS XQWLO UHVLVWDQFH IURP WKH DQFKRU FDWFKLQJ RQ WKH GLVWDO WLS RI WKH LQVHUWLRQ VKHDWK LV IHOW 7R HQVXUH WKH FRUUHFW DQFKRU SRV...

Page 9: ...n the artery Fig 12 KHQ WKH LQVHUWLRQ VKHDWK FOHDUV WKH VNLQ D WDPSHU WXEH ZLOO DSSHDU LJXUH W WKLV VWDJH JULS WKH WDPSHU WXEH DQG JHQWO DGYDQFH WKH NQRW DQG FROODJHQ ZKLOH PDLQWDLQLQJ WHQVLRQ RQ WKH...

Page 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...

Page 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...

Page 12: ...RU RQ WKH RUGHU RI D SK VLFLDQ HHS GU HHS DZD IURP VXQOLJKW LQFOXGLQJ 89 OLJKW 6WRUH RQO DW WHPSHUDWXUHV EHWZHHQ DQG Reorder Number or Catalog Number RW 1XPEHU Do not use if temperature indicator dot...

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