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How To Use SafeTouch™ Breast Lump Relocation Device
Indications For Use
The SafeTouch™ marker sheet is intended to be used for marking the location of breast
lumps that have been identified or suspected during breast examinations. The radio-opaque numbered grid on the marker sheet
can be used to assist another physician or care provider in relocating a breast lump, for further evaluation. When the initial
examiner suspects a breast lump they will place a SafeTouch™ marker sheet over the breast, positioning
the pre-printed circle over the nipple, with the arrow symbol centered vertically on the nipple. The location of the lump is marked
upon the sheet with the permanent marker that is included and noted in the patients chart indicating the grid number where a
suspected lump was detected.
Description of SafeTouch™Sheets
SafeTouch™ consists of a plastic sheet preprinted with a center circle for orientation and a radio-opaque numbered
grid for breast lump localization. The underside of the device has areas of light adhesive to anchor the sheet while in use.
The marker sheet is used to mark or report the position of suspected breast lump(s) to assist another physician or care
provider in relocating a lump, for further evaluation.
Directions for Use
- During the application of the device the patient will be supine, with the breast to be examined uncovered, and her corresponding arm lying up beside her head. See Figure 1.
- Carefully peel off the silicone liner, exposing the adhesive beneath the center circle and along the medial and lateral edges. A reinforcing paper strip will remain along the medial and lateral edges for ease of use. See Figure 2.
- The examiner will place the SafeTouch(TM) marker sheet over the breast, positioning the pre- printed adhesive coated circle over the nipple, with the arrow centered vertically on the nipple. Use the cross-hairs in the center of the circle to help position the sheet.
- Note: When the device is positioned correctly, the SafeTouch(TM) logo will be at the lower right corner of the sheet. If necessary, after placing the sheet over the nipple, the silicone strips at the edges may be removed to provide a larger surface for adherence to the breast and chest wall.
- Re-examine the suspected area of the breast through the exam sheet. When the suspected lump is re-located, mark the location of the lump(s) upon the affected grid area and record the grid numbers in the patient's chart, for future reference. See Figure 3.
- Remove the SafeTouch(TM) sheet from the patients chest. Lay it face down on a flat, dry surface. Re-apply the backing sheet with the shiny side facing the sheet. Either role it up with the numbers facing out, or, fold it carefully and give it to the patient so that she may take it to the next examination.
- Send the marked sheet with the patient to her next examination along with a written report of the numbered grid indicating the location of the discovered breast lump. As an alternative, if the patient chooses to keep the original sheet, a new sheet may be marked and sent with the patient to the next examination.
- The next examiner will apply SafeTouch(TM) to the appropriate breast in the manner described above. The marked grid should approximate the location of the previously discovered breast lump.
- This product makes no explicit or implied claim to find breast cancer, breast lumps, or any other breast disease.
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Figure 1
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Figure 2
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Figure 3
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Visionary Concepts, Elegant Design, Dependable Function
{Rusin Medical Devices, LLC}
{Dr. James D. Rusin, MD, MBA}
{SafeTouch™ Instructions}
{Request More Info}
{SafeTouch(TM)}
| | SafeTouch™ Marker Sheet
Dr. James Rusin, MD, MBA
PO Box 445, Anoka, Minnesota 55303 |
| | info@rusinmedical.com | 763-712-0274 | www.rusinmedical.com |
| | © Copyright 2002-2008 Rusin Medical Devices, LLC
SafeTouch™ is a registered Trademark of Rusin Medical Devices, LLC.
US Patents #6,412,491 and #6,622,728 |
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