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Device lifetime: The Melody™ TPV is used in the palliative treatment of RVOT conduit or bioprosthetic valve dysfunction with
a goal of delaying the next surgical intervention. Some patients will require valve reintervention or replacement, the timing of
which is dependent on several factors.
4.1. Warnings
4.1.1. TPV
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing,
or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which
could result in patient injury, illness, or death.
Do not resterilize the TPV by any method.
Exposure of the device and container to irradiation, steam, ethylene oxide, or other chemical sterilants will render the device
unfit for use.
Do not use the device if:
■
The device has been dropped, damaged, or mishandled in any way
■
The Use By date has elapsed
■
Each tamper-evident seal is broken
■
The serial number tag on the TPV does not match the serial number on the container label
■
The shipping temperature indicator window inside the shelf carton is black. If the shipping temperature indicator is black,
the TPV is not suitable for clinical use.
■
The storage solution does not completely cover the device or there is evidence of leakage
Do not expose the device to solutions other than the storage and rinsing solutions.
Do not add antibiotics to either the storage or the rinse solution. Do not apply antibiotics to the device.
Do not allow the device to dry. Maintain tissue moisture with irrigation or immersion.
Do not attempt to repair a damaged device.
Do not handle or use forceps to manipulate the valve leaflet tissue.
Do not use forceps to manipulate the stent.
Do not overexpand the device beyond the maximum recommended size as shown in Table 1, as this may result in a
regurgitant TPV.
4.1.2. Delivery system
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing,
or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which
could result in patient injury, illness, or death.
Do not dilate the balloon appreciably beyond the diameter of the obstructive vessel and the intended implant site.
Do not use air or any gaseous substance as a balloon-inflation medium.
Do not advance the guidewire, balloon-dilatation catheter, or any other component if resistance is met, without first determining
the cause and taking remedial action.
Do not remove the guidewire from the delivery system at any time during the procedure.
4.2. Precautions
■
Rinsing procedures of the TPV must be strictly followed to avoid necrosis of the tissue at the site of implantation.
■
Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure
to or breathing of the chemical vapor. Use only with adequate ventilation. If skin contact occurs, immediately flush the
affected area with water for a minimum of 15 minutes. In the event of eye contact, flush with water for a minimum of
15 minutes and seek medical attention immediately.
■
The sealed delivery system packaging should be inspected prior to opening. If the seal is broken or the packaging has been
damaged, sterility cannot be assured.
■
Proper functioning of the delivery system depends on its integrity. Use caution when handling the delivery system. Damage
may result from kinking, stretching, or forceful wiping of the delivery system.
■
This delivery system is not recommended for pressure measurement or delivery of fluids.
■
Maintain tight catheter connections and use aspiration before proceeding to avoid air introduction into the system.
■
The delivery system must be carefully flushed to avoid the introduction of air bubbles.
■
Before crimping (reducing) the size of the TPV on the balloon, the orientation and function of the valve must be tested.
■
Do not take off the labels. These determine the orientation of the TPV before the crimping procedure on the balloon is
completed.
8
Instructions for Use
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