Mri Safety Information; Warranty Disclaimer; Technical Support - Merit Medical HERO GRAFT Mode D'emploi

MRI Safety Information

Non-clinical testing has demonstrated that the HeRO Graft System is MR Conditional. A patient with this device can be safely scanned in an MR system
meeting the following conditions:
• Static magnetic field of 1.5 and 3.0 Tesla only
• Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m) or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under the scan conditions defined above, the HeRO Graft System is expected to produce a maximum temperature rise of 4.8ºC after 15 minutes of
continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 10mm from the HeRO Graft System when imaged with a
gradient echo pulse sequence and a 3 Tesla MRI system. The artifact does obscure the device lumen.

WARRANTY DISCLAIMER

ALTHOUGH 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, 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. Shah, et al., 2011. Vascular access thrombosis and interventions in patients missing hemodialysis sessions. Clin Nephrol, Dec 2011; 76(6): 435-9
4. Illig KA. Management of Central Vein Stenosis and Occlusions: The Critical Importance of the Costoclavicular Junction. Semin Vasc Surg 24:113-118,
2011.
5. Data on file.
6. Lucas, George F. 2007. Scientific Review of Adverse Events related to the use of Chronic Hemodialysis Catheters (not including infections). Data
on file.
7. Lucas, George F. 2007. Scientific Review of Adverse Events in Hemodialysis Grafts. Data on file.
8. Katzman H. (2009). Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. Journal Vascular Surgery,
600-607.
9. Hajjar J, Girard R, Marc JM, et al. [Surveillance of infections in chronic hemodialysis patients (Article in French)]. Nephrologie 2004;25:133-40.
10. 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.
A bibliography of HeRO Graft publications and presentations is available at www.merit.com/hero.
ENGLISH
Authorized Representative:
Merit Medical Ireland Ltd
Parkmore Business Park West
Galway, Ireland
EC Customer Service +31 43 3588222
www.merit.com/hero
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