Packaging - LeMaitre Omniflow II Gebrauchsanweisung

Safe Handling and Disposal
If serious medical incidents should arise during use of this medical device, users should notify both LeMaitre Vascular and the
Competent Authority of the country where the user is located. This product contains no sharps, heavy metals or radioisotopes, and
is not infectious or pathogenic. No special requirements for disposal are evident. Please consult local regulations to verify proper
disposal. Dispose storage solution according to local and federal regulations. Solution should not be disposed using septic systems.
If there are no disposal restrictions, solution may be diluted and disposed in a sanitary sewer system. For more information see:
https://www.osha.gov/Publications/glutaraldehyde.pdf
Packaging and shipping of explanted Omni ow:
Return of the shipment to LeMaitre Vascular depends on 3 crucial questions:
1. Is the explant obtained from a patient with a known or presumed pathogenic condition at the time of the explant?
2. Is the explant obtained from a patient that has a known treatment history that involves therapeutic radionuclides within the
last 6 months?
3. Has the clinician obtained consent from the patient for the sample to be returned to the manufacturer for research purposes?
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 Omni ow prostheses should be directly transferred to a sealable container lled with a solution of alkaline buff ered
2% glutaraldehyde or 4% formaldehyde prior to shipment.
2. Cleaning of explanted prostheses should be minimal if necessary. Proteolytic digestion should not be used in any circumstances.
3. Omni ow 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 noti ed".
3. Packages prepared in the above manner may be shipped to:
Attn: Complaint Lab
Burlington, MA 01803, USA
Resterilization/Re-use
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility of the re-processed device cannot
be assured. Reuse of the device may lead to cross contamination, infection, or patient death. The performance characteristics of the
device may be compromised due to reprocessing or re-sterilization since the device was only designed and tested for single use.
The shelf life of the device is based on single use only. The unused section of the Omni ow II prosthesis or the explanted prosthesis
should be considered as biohazard and be disposed per hospital policy or local regulations.
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 speci 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 purchase price for, this device (at LeMaitre
Vascular's sole option) following the purchaser's return of the device to LeMaitre Vascular. This warranty shall terminate on the
expiration date for this device.
LeMaitre Vascular
63 Second Avenue
6