Instructions For Use; Device Description - Merit Medical Hero Graft Instrucciones De Uso

INSTRUCTIONS FOR USE

Federal (USA) law restricts this device to sale by or on the order of a physician.
Only qualified healthcare providers should place, manipulate, declot, revise or explant the device.
Carefully read all instructions prior to use.
Adhere to universal precautions when inserting, maintaining or explanting the device.
STERILE (EO) – FOR SINGLE USE ONLY
Each component of the HeRO® Graft is provided in double sterile barrier packaging and is EO sterilized.
STORAGE
To provide maximum protection, store the HeRO Graft components in their original, unopened packages at room temperature. Keep dry and out of
direct sunlight. Each component must be used before the use by date printed on the individual labels.
Caution: consult accompanying documents
Use-By Date
Single Use
Sterilized Using Ethylene Oxide
Catalogue Number
Batch Code
Authorized Representative in the
European Community
Not Made with Natural Rubber Latex
Revision Kit

DEVICE DESCRIPTION

The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is
a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. The HeRO Graft
traverses central venous stenosis allowing for long-term hemodialysis access.
HeRO Graft consists of a proprietary Venous Outflow Component and the Adapter:
The Venous Outflow Component (may be included) has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of
radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip.
The Adapter connects a 6mm ID vascular graft (not included in Merit packaging) to the Venous Outflow Component. The Adapter (titanium
alloy) has a tapered ID (6mm to 5mm) to provide a smooth transition from a 6mm ID vascular graft to the 5mm ID Venous Outflow Component. A
disposable Graft Expander is provided to aid in connecting a 6mm ID vascular graft to the Adapter . The Support Seal is only required for select
grafts to provide seal reinforcement and kink resistance near the Adapter . See ASSEMBLING THE ADAPTER section or the Graft Reference Card
for more details on grafts that require the Support Seal.
NOTE: To determine when the Support Seal is required, refer to Tables 1 and 2 in the ASSEMBLING THE ADAPTER section of the
document as well as on the Adapter packaging.
Graft Expander
Graft Expansion End
NOTE: The clamshells are always on the inflow graft end of the Adapter .
Option A or B:
Venous Outflow Component
5mm ID
19F OD
Graft Expander
Shoulder
Adapter
Clamshells
Inflow
Graft
End
ENGLISH
40cm silicone-coated
outflow component
Radiopaque
marker band
Kink & crush resistant
nitinol reinforcement braid
Support Seal
Adapter
Shoulder
3
MR Conditional
Non-Pyrogenic
Do Not Resterilize
Manufacturer
Keep Dry
Keep Away from Sunlight
Do Not Use if Package is Damaged
For electronic copy scan QR Code, or go to
www.merit.com/ifu and enter IFU ID Number.
For printed copy, call U.S.A or E.U. Customer
Service
Coil
Silicone Sleeve
Venous
Outflow
Component
End