LeMaitre AlboGraft Gebrauchsanweisung Seite 6

In the event that the response to question 1 or 2 is affi rmative, LeMaitre Vascular does not provide
adequate guidance for shipment. THESE EXPLANTS SHOULD NOT BE RETURNED TO LEMAITRE VASCULAR
UNDER ANY CIRCUMSTANCES. In these cases, the explant should be disposed according to local
regulations.
For explants that do not have pathogenic or radiologic hazards, please use the following:
Pre-explantation:
1. If possible, perform a CT or Ultrasound scan of the device to document patency.
2. LeMaitre Vascular can accept clinical information that is patient-anonymized. LeMaitre Vascular
requests information including:
a) The original diagnosis which resulted in use of the implant,
b) The patient's medical history relevant to the implant, including the hospital or clinic at which
the device was implanted.
c) The patient's implant experience prior to implant removal.
d) The hospital or clinic at which the explantation was done, and date of retrieval.
Explantation:
1. Explanted AlboGraft grafts should be directly transferred to a sealable container fi lled with a
solution of alkaline buff ered 2% glutaraldehyde or 4% formaldehyde prior to shipment.
2. Cleaning of explanted grafts should be minimal if necessary. Proteolytic digestion should not be
used in any circumstances.
3. AlboGraft explants should not be decontaminated under any circumstances. DO NOT autoclave the
sample or use ethylene oxide gas to decontaminate.
Packaging:
1. Explants should be sealed and packed in a manner that minimizes potential for breakage,
contamination of the environment or exposure to those handling such packages during transit.
Material that is absorbent and is cushioning should be selected for isolating the sealable container
inside the secondary packaging. Primary and secondary packaging must then be packaged inside
an outer package.
2. Explants in sealed primary containers should be labeled with an ISO 7000-0659 Biohazard symbol.
The same symbol should be attached to the secondary packaging and to the outer packaging.
Outer packaging should also be labelled with Name, Address and Telephone Number of Sender,
and the statement, "Upon discovery of damage or leakage, the package should be isolated and
sender notifi ed".
3. Packages prepared in the above manner may be shipped to:
LeMaitre Vascular
63 Second Avenue
Burlington, MA 01803
Notices: Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc., warrants that reasonable care has been used in the manufacture of this device and that
this device is suitable for the indication(s) expressly specifi ed in these instructions for use. Except as explicitly
provided herein, LEMAITRE VASCULAR (AS USED IN THIS SECTION, SUCH TERM INCLUDES LEMAITRE VASCULAR,
INC., ITS AFFILIATES, AND THEIR RESPECTIVE EMPLOYEES, OFFICERS, DIRECTORS, MANAGERS, AND AGENTS)
MAKES NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT TO THIS DEVICE, WHETHER ARISING BY OPERATION
OF LAW OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE) AND HEREBY DISCLAIMS THE SAME. This limited warranty does not
apply to the extent of any abuse or misuse of, or failure to properly store, this device by the purchaser or any
third party. The sole remedy for a breach of this limited warranty shall be replacement of, or refund of the
* Not available for sale in the United States or Canada.
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