Merit Medical Hero Graft Instrucciones De Uso página 5

Caution: If leakage is observed, check for proper connection of the Arterial Graft Component to the Venous Outflow
Component.
ARTERIAL GRAFT COMPONENT AND ARTERY CONNECTION
Arterial Graft Component
1. Cut the to length, avoiding excessive tension or excess material. Verify there are no kinks, twists, or bends in the
Graft Component.
2. Perform the arterial anastomosis utilizing standard surgical techniques.
Caution: Use a small diameter tapered needle with a non-cutting edge to reduce the incidence of suture
hole bleeding.
3. Remove the clamp and check the device patency utilizing standard Doppler technique.
4. Verify thrill and bruit.
5. Evaluate for steal syndrome during the implant procedure with Doppler of the radial and ulnar arteries. If steal syndrome symptoms occur, consider surgical
interventions such as:
• DRIL (distal revascularization-interval ligation) procedure
• Banding, though this may reduce the flow in the HeRO Graft
• Proximalization of the inflow
6. Close all three incision sites.
POST IMPLANT INFORMATION
1. Complete the Implant Notification Fax Form in the Patient Information Pouch and fax the completed form to the patient's
2. Provide the patient with the remaining items in the Patient Information Pouch.
VASCULAR ACCESS CANNULATION
Follow KDOQI guidelines for graft assessment, preparation and cannulation.
• The Arterial Graft Component requires 2-4 weeks to incorporate prior to cannulation.
• Swelling must subside enough to allow palpation of the entire Arterial Graft Component.
• Rotation of cannulation sites is needed to avoid pseudoaneurysm formation.
• A light tourniquet may be used for cannulation as the thrill and bruit may be softer than a conventional ePTFE graft due to the elimination of the venous
anastomosis.
Post-dialysis, and following needle removal, apply moderate digital pressure at the puncture site until hemostasis is achieved. To decrease the risk of an occlusion, do
not use mechanical clamps or straps.
Caution: DO NOT cannulate the HeRO Graft within 8cm (3") of the DPG incision to avoid damage to the
beaded section of the Arterial Graft Component.
Caution: DO NOT cannulate the Venous Outflow Component.
Caution: Remove the bridging catheter as soon as possible once the HeRO Graft is ready to be cannulated
to decrease the risk of an infection related to the bridging catheter.
Caution: All bridging catheters should be cultured upon explant. In the event catheter tip cultures are
positive, treat the patient with appropriate antibiotics to decrease the risk of the HeRO Graft
becoming infected.
For additional information refer to the HeRO Graft Care & Cannulation Guide in the patient information or review online at www.merit.com/hero.
PERCUTANEOUS THROMBECTOMY
The HeRO Graft will require maintenance equivalent to conventional ePTFE grafts. The HeRO Graft can be up to 90cm long; thus requiring a longer thrombectomy device
to traverse the entire length of the device.
Caution: Do not use mechanical/rotational thrombectomy devices (e.g., Arrow-Trerotola PTD®) in the
Venous Outflow Component and/or connector as internal damage may occur to these components.
For specific thrombectomy instructions or guidance, please contact Customer Service for a copy of the Thrombectomy Guidelines or it may also be found on www.
merit.com/hero.
DEVICE EXPLANT, EXCHANGE, REVISION OR ABANDONMENT
Venous Outflow Component
The HeRO Graft and connection portion should be removed if the device will not be used for hemodialysis access. In
situations where the HeRO Graft requires exchange, explant or revision, please contact Customer Service for an instruction procedure and an Explant Return Kit.
Instructions may also be found in the Frequently Asked Questions section of www.merit.com/hero.
MRI INFORMATION
The HeRO Graft was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International,
Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005.
Non-clinical testing has demonstrated that the HeRO Graft is MR-conditional. A patient with this device can be scanned safely immediately after placement under the
following conditions:
• Static magnetic field of 3-Tesla or less
• Spatial gradient magnetic field of 720-Gauss / cm or less
MRI-Related Heating
In non-clinical testing, the device produced the following temperature rise during MRI performed for 15-min in the 3-Tesla (3-Tesla / 128-MHz, Excite, Software G3.0-
052B, General Electric Healthcare, Milwaukee, WI) MR system: Highest temperature change +1.6°C.
Therefore, the MRI-related heating experiments for the device at 3-Tesla using a transmit / receive radiofrequency (RF) body coil at an MR system reported whole body
averaged SAR of 3.0-W / kg (i.e., associated with a calorimetry measured value of 2.8-W / kg) indicated that the greatest amount of heating that occurred in association
with these specific conditions was equal to or less than +1.6°C.
Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR
imaging parameters to compensate for the presence of this device may be necessary.
Pulse Sequence T1-SE
2
Signal Void Size: 7,849 mm
Plane Orientation: Parallel
ENGLISH
dialysis center
T1-SE GRE GRE
2 2
295 mm 9,519 mm 1,273 mm
Perpendicular Parallel Perpendicular
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WARRANTY DISCLAIMER
THIS PRODUCT HAS BEEN MANUFACTURED UNDER CAREFULLY CONTROLLED CONDITIONS WITH ALL
REASONABLE CARE, MERIT MEDICAL SYSTEMS, INC. HAS NO CONTROL OVER THE CONDITIONS UNDER
WHICH THIS PRODUCT IS USED. MERIT MEDICAL SYSTEMS, INC. THEREFORE DISCLAIMS ALL WARRANTIES,
Arterial
BOTH EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT INCLUDING, BUT NOT LIMITED TO, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING
FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. DESCRIPTIONS OR SPECIFICATIONS IN MERIT
MEDICAL SYSTEMS, INC. PRINTED MATERIAL, INCLUDING THIS PUBLICATION, ARE MEANT SOLELY TO
GENERALLY DESCRIBE THE PRODUCT AT THE TIME OF MANUFACTURE AND DO NOT CONSTITUTE ANY
EXPRESS WARRANTIES. MERIT MEDICAL SYSTEMS, INC. SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY
FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY
USE, DEFECT, FAILURE OR MALFUNCTION OF THE PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS
BASED UPON WARRANTY, CONTRACT, TORT OR OTHERWISE. NO PERSON HAS ANY AUTHORITY TO BIND
MERIT MEDICAL SYSTEMS, INC. TO ANY REPRESENTATION, CONDITION, WARRANTY OR LIABILITY WITH
RESPECT TO THE PRODUCT.
THE EXCLUSIONS AND LIMITATIONS SET OUT ABOVE ARE NOT INTENDED TO, AND SHOULD NOT BE
CONSTRUED SO AS TO CONTRAVENE MANDATORY PROVISIONS OF APPLICABLE LAW. IF ANY PART OR
TERM OF THIS WARRANTY DISCLAIMER IS HELD TO BE ILLEGAL, UNENFORCEABLE OR IN CONFLICT WITH
APPLICABLE LAW BY A COURT OF COMPETENT JURISDICTION, THE VALIDITY OF THE REMAINING PORTIONS
OF THIS WARRANTY DISCLAIMER SHALL NOT BE AFFECTED, AND ALL RIGHTS AND OBLIGATIONS SHALL BE
. CONSTRUED AND ENFORCED AS IF THIS WARRANTY DISCLAIMER DID NOT CONTAIN THE PARTICULAR PART
OR TERM HELD TO BE INVALID AND THE INVALID PART OR TERM SHALL BE SUBSTITUTED BY A VALID PART
OR TERM WHICH BEST REFLECTS MERIT MEDICAL SYSTEMS, INC.'S LEGITIMATE INTEREST IN LIMITING ITS
LIABILITY OR WARRANTY.
In the event that such a disclaimer is found invalid or unenforceable for any reason: (i) any action for breach of warranty must be commenced within one year after any
such claim or cause of action accrued and (ii) the remedy for such breach is limited to the replacement of the product. Prices, specifications and availability are subject
to change without notice.
TECHNICAL SUPPORT
To obtain additional information on the HeRO Graft, including questions on infection control procedures, contact the customer service department at:
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095, U.S.A.
1-801-253-1600 U.S.A
Customer Service 1-800-356-3748
www.merit.com/hero
REFERENCES
1. Vascular Access Work Group. National Kidney Foundation KDOQI clinical practice guidelines for vascular access. Guideline 1: patient preparation for
permanent hemodialysis access. Am J Kidney Dis 2006;48(1Suppl1):S188-91.
2. Hemodialysis Adequacy 2006 Work Group. National Kidney Foundation KDOQI clinical practice guidelines for hemodialysis adequacy, update 2006. Am
J Kidney Dis 2006;48(Suppl 1):S2-S90.
3. Data on file.
4. Lucas, George F. 2007. Scientific Review of Adverse Events related to the use of Chronic Hemodialysis Catheters (not including infections). Data on file.
5. Lucas, George F. 2007. Scientific Review of Adverse Events in Hemodialysis Grafts. Data on file.
6. Hajjar J, Girard R, Marc JM, et al. [Surveillance of infections in chronic hemodialysis patients (Article in French)]. Nephrologie 2004;25:133-40.
7. Katzman H. (2009). Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. Journal Vascular Surgery,
600-607.
8. Shah, Ravish. 2010. Impact of Missing Hemodialysis sessions on Arteriovenous Access Thrombosis. Data on file.
9. Illig K A. Management of Central Vein Stenosis and Occlusions: The Critic al Impor tance of the Cos toclavicular Junc tion.
Semin Vasc Surg 24:113-118, 2011.
A bibliography of HeRO Graft publications and presentations is available at www.merit.com/hero.
GENERAL WARNING
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or
resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but
not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury,
illness or death of the patient.
All trademarks are the property of their respective owners.
© 2016 Merit Medical Systems, Inc. All rights reserved.
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Manufacturer:
Merit Medical Systems, Inc.
1600 West Merit Parkway, South Jordan, Utah 84095
U.S.A. 1-801-253-1600 U.S.A Customer Service 1-800-356-3748
Authorized Representative:
Merit Medical Ireland Ltd, Parkmore Business Park West, Galway, Ireland
EC Customer Service +31 43 358822
ENGLISH
Authorized Representative:
Merit Medical Ireland Ltd
Parkmore Business Park West
Galway, Ireland
EC Customer Service +31 43 358822
www.merit.com/hero
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