Assembling The Adapter - Merit Medical Hero Graft Instrucciones De Uso

20. Attach a syringe to the stopcock and unclamp the Venous Outflow Component. Aspirate and close the stopcock. Reclamp the Venous Outflow
Component and remove the syringe.
21. Attach a syringe with heparinized saline. Open the stopcock, remove the clamp and flush the Venous Outflow Component. Reclamp the
Venous Outflow Component at the incision site and close the stopcock.
22. Return the patient to standard supine position.
23. Make the Adapter site incision at the deltopectoral groove (DPG).
24. Holding the Venous Outflow Component away from the incision sites, use heavy duty scissors to make a straight cut and remove the silicone
Luer. Discard the unused portion.
Caution: Avoid displacing the Venous Outflow Component tip during manipulation.
Caution: The cut end of the Venous Outflow Component may have sharp edges. Avoid glove contact to prevent puncture.
25. Using a standard Bard® Kelly-Wick tunneler with a 6mm bullet tip, tunnel from the DPG to the venous incision site.
26. Insert the 6mm bullet tip into the end of the Venous Outflow Component, pull through the tunnel to the DPG and remove the bullet tip.
Caution: DO NOT bend the Venous Outflow Component beyond a 2.5cm diameter anywhere along its length to prevent kinking.
NOTE: Alternatively, a GORE® Tunneler or Bard Bi-Directional Tunneler may be used. Consult manufacturer IFUs for proper utilization.

ASSEMBLING THE ADAPTER

ATTENTION: The clamshells cannot be opened once closed; do NOT close the clamshells prematurely.
The Adapter has undergone successful in vitro testing with the following vascular grafts in Tables 1 and 2.
Table 1: Marketed 6mm ID Early Cannulation
Trade Name Manufacturer
FLIXENE®
Atrium Medical Corp.
Standard Wall
GORE® ACUSEAL
FLIXENE is a registered trademark of Atrium Medical Corporation.
GORE is a registered trademark of W.L. Gore and Associates.
I. Refer to graft manufacturer Instructions for Use or website for indications and further information; II. Catalogue numbers may contain identifiers that are not reflected on this
table. Consult the graft manufacturer's website to determine which equivalent catalog numbers are available in your region.
Table 2: Marketed 6mm ID Standard Wall
Trade Name Manufacturer
IMPRA®
GORE-TEX® W.L. Gore & Associates
GORE-TEX®
W.L. Gore & Associates
Stretch
GORE®
W.L. Gore & Associates
PROPATEN®
IMPRA is a registered trademark of C.R. BARD, Inc.
GORE-TEX, GORE, and PROPATEN are registered trademarks of W.L. Gore and Associates.
I. Refer to graft manufacturer Instructions for Use or website for indications and further information; II. Catalogue numbers may contain identifiers that are not reflected on this
table. Consult the graft manufacturer's website to determine which equivalent catalog numbers are available in your region.
GENERAL WARNINGS:
Caution: The Adapter should only be used with the grafts listed in Tables 1 and 2. Use of other grafts not listed in Tables 1 or 2 may
result in device failure and patient injury due to inadequate sealing or graft disconnection.
Caution: Assembly of the Adapter, Support Seal (if applicable) and selected graft from Table 1 and 2 should be done using powder
free, clean and dry gloves.
1. Select a new graft from Table 1 or 2.
2. Using aseptic technique, open the Adapter package and the selected graft and deliver to the sterile field.
3. Remove all the parts from the Adapter pouch insert card.
Vascular Grafts (qualified for use with the Adapter)
I
W.L. Gore
& Associates
Vascular Grafts (qualified for use with the Adapter and Support Seal)
I
05S06 | 10S06 | 20S06 | 30S06 | 40S06 | 50S06
C.R. Bard
H060010A | H060040A | H060060A | H060080A
ENGLISH
Catalogue Number
25053
25142
25052
ECH060010A
ECH060020A
ECH060040A
ECH060050A
Catalogue Number
60S06 | 70S06 | 80S06 | 90S06
V06010L | V06020L | V06030L | V06040L
V06050L | V06070L | V06080L
S0601 | S0602 | S0603 | S0604 | S0605
S0607 | S0608 | S0609
7
Support Seal Required for
II
HeRO Graft Adapter
Support Seal Required for
II
HeRO Graft Adapter
NO
NO
YES
YES
YES
YES