Idiomas disponibles
Idiomas disponibles
Instructions for Use
1
®
The U
W
One-Handed Breast Localization Device consists of a plastic molded handle, an
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introducer needle with 1cm depth reference marks, and an ultrasound enhancement on the distal end
to aid in needle placement. A semi-rigid dual barb localization wire is loaded inside the handle. The
handle has a trigger which when activated will cause the needle to retract back into the handle
exposing the dual barb localization wire. The wire contains a visual bead between the barbs.
®
The U
W
One-Handed Breast Localization Device is supplied sterile and non-pyrogenic unless
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the package has been damaged or opened. Sterilized using Ethylene Oxide.
This device is intended for use during breast lesion surgery as a guide for the surgeon to follow in the
excision of the lesion.
None known.
®
U
W
One-Handed Breast Localization Device has been designed for single use
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pyrogenic or microbial contamination have had contact with the medical device for an
contamination of the device with pyrogens or microorganisms which may lead to
degree of potential pyrogenic or microbial contamination which may lead to infectious
increases the probability that the device will malfunction due to potential adverse effects
1. This device should only be used by a physician trained in its indicated use, limitations, and
possible complications of percutaneous needle techniques.
2. The introduction of the device into the body should be carried out under imaging control
(ultrasound or x-ray).
3. Before using, inspect the device for damage that would prevent proper function. If the
components are damaged or bent, DO NOT USE.
adjacent tissue injury, pain, bleeding, hemoptysis, hemothorax, non-target tissue, organ or vessel
perforation, and pneumothorax.
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5
6
1. Breast localization device
2. Ultrasound enhancement
3. 1cm depth reference marks
4. Trigger
5. Barbs
6. Bead
7. Localization wire
®
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