LeMaitre XenoSure 0.6BV8 Mode D'emploi page 4

Alternate Patch Size Rinse Procedure
For any patch size not listed in the table, use the following rinse instructions.
Patch length (cm) x Patch width (cm) = Patch area (cm
If the patch has an area less than or equal to 37.5cm
If the patch has an area greater than 37.5cm
Note: The patch area is based on one side of the patch. This calculation has been formulated intentionally. Please follow the instructions.
Implantation
Cut and/or trim the XenoSure Biologic Patch to the desired shape. Any excess XenoSure Biologic Patch material should be treated as biological waste and
discarded according to hospital procedure.
During implantation, irrigate the XenoSure Biologic Patch tissue frequently with sterile physiologic saline to prevent drying. Visually examine both sides of the
XenoSure® Biologic Patch. If one side appears smoother, implant the smoother surface so that it faces the blood flow.
Surgical Technique
It is beyond the scope of this Instructions for Use booklet to instruct the surgeon in specific repair procedures. LeMaitre Vascular, Inc. assumes that any surgeon
performing the above operations has received adequate training and is thoroughly familiar with the pertinent scientific literature.
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 XenoSure:
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 affirmative, 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.
Model Size (cm)
0.6BV8 0.6x8
0.8BV8 0.8x8
1BV6 1x6
1BV10 1x10
1.5BV10 1.5x10
1BV14 1x14
2BV9 2x9
2.5BV15 2.5X15
4BV4 4x4
4BV6 4x6
5BV10 5x10
6BV8 6x8
8BV14 8x14
10BV16 10x16
12BV25 12x25
)
2
, the patch requires a rinse time of 2 minutes in 500ml of saline.
2
and less than or equal to 300cm
2
Rinse Procedure
500ml for 2 minutes
minimum
1000ml for 3
minutes minimum
, the patch requires a rinse time of 3 minutes in 1000ml of saline.
2
4