LeMaitre MultiTASC 4500-03 Mode D'emploi page 7

the arrow indicated on the handle until a positive stop is detected (approximately 90°). Inspect the rings for
misalignment, this may be done under fluoroscopy. If rings are misaligned, do not use device. Disconnect the
actuator handle from the hub. Attach the hub cap to the hub. Loosen torque handle cap from the retainer
and attach torque handle to the shaft. Position the torque handle in desired position and tighten torque
handle cap. Return to Step 8 to complete dissection.
Storage
Store in a cool, dry place.
Re-sterilization/Repackaging
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 and structural integrity 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. If for any reason this device must be returned to LeMaitre Vascular, place it in its original packaging
and return it to the address listed on the box.
Safe Handling and Disposal
This device is single-use and disposable device. Do not implant. Please return the used device only at the time that
the device has not performed as intended or the device is related to an adverse event. In other situations, the device
should not be returned but disposed accorded to local regulations.
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.
Cleaning:
1. Devices considered necessary to return should be cleaned using one of the following:
a) Sodium hypochlorite solution (500-600 mg/l), or
b) Peracetic acid solution with subsequent ultrasonic treatment
2. Devices should then be decontaminated with either:
a) 70% solutions of ethanol or isopropanol for a minimum of 3 hours or,
b) Ethylene oxide gas
3. Devices should be completely dried prior to packaging.
Packaging:
1. Cleaned devices 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. For devices capable of
penetrating or cutting skin or packaging material, the primary packaging must be capable of maintaining the
product without puncture of the packaging under normal conditions of transport.
2. The sealed primary container should be placed inside watertight secondary packaging. The secondary packaging
should be labelled with an itemized list of the contents of the primary receptacle. Cleaning methods should be
detailed if possible.
3. Both primary and secondary packaging of cleaned, decontaminated single-use disposable devices should be
labelled with an ISO 7000-0659 Biohazard symbol.
4. Primary and secondary packaging must then be packaged inside an outer package, which must be a rigid,
fiberboard box. The outer shipping container must be provided with sufficient cushioning material to prevent
movement between the secondary and outer containers.
5. Shipping paper and content marking for the outer shipping container are not required.
6. Packages prepared in the above manner may be shipped to:
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LeMaitre Vascular
Attn: Complaint Lab
63 Second Avenue
Burlington, MA 01803