Hologic Affirm Prone Biopsy Equipment Drape Kit Operating instructions

Type
Operating instructions

Hologic Affirm Prone Biopsy Equipment Drape Kit is a sterile, single-use device intended for use during prone breast biopsy procedures. The drape kit helps to maintain a clean and sterile environment during the procedure and helps to prevent contamination of the C-arm assembly. The drape kit consists of three sections: a drape for the breast platform, a drape for the biopsy device mount, and a clear cover for the control panel. The drape for the breast platform has a clear plastic pop-up section to cover the paddle mount.

Hologic Affirm Prone Biopsy Equipment Drape Kit is a sterile, single-use device intended for use during prone breast biopsy procedures. The drape kit helps to maintain a clean and sterile environment during the procedure and helps to prevent contamination of the C-arm assembly. The drape kit consists of three sections: a drape for the breast platform, a drape for the biopsy device mount, and a clear cover for the control panel. The drape for the breast platform has a clear plastic pop-up section to cover the paddle mount.

Affirm Prone Biopsy System Equipment Drape Set
User Instructions
MAN-05652 Revision 001 Hologic, Inc. Page 1 of 2
36 Apple Ridge Road, Danbury, CT 06810 (800) 447-1856
© 2018 Hologic, Inc. The information contained in this document is proprietary. Unauthorized distribution is prohibited.
This document provides instructions for installing the Equipment Drape Set for the
Affirm® prone breast biopsy guidance system. The Drape Set is used to prevent fluids
from contaminating portions of the C-arm assembly.
The Drape Set consists of three sections:
drape for the breast platform (with a clear plastic pop-up section to cover the paddle
mount)
drape for the biopsy device mount (with a flap section for inside the paddle)
clear cover for the control panel
Warning:
Change the drapes and the control panel cover after each patient.
Warning:
Discard the materials as you would any other contaminated material.
1: Installation
Note
Keep in mind the following when installing the drapes:
Install the needle guide holder on the biopsy device mount before installing drapes.
Install the paddle and biopsy device in the order marked in these illustrations.
Place the blue (absorbent) side of the drape facing up.
Install breast platform drape section on breast platform
and over paddle mount. Peel off adhesive under drape
(item 1) and attach to image receptor right below white
square (do not cover white square area). Tear off excess
drape at perforation (item 2) and save for later.
Attach paddle on the paddle mount (item 3) over the
clear plastic pouch section of the drape.
Introduction
Affirm Prone Biopsy System Equipment Drape Set
User Instructions
MAN-05652 Revision 001 Hologic, Inc. Page 2 of 2
36 Apple Ridge Road, Danbury, CT 06810 (800) 447-1856
© 2018 Hologic, Inc. The information contained in this document is proprietary. Unauthorized distribution is prohibited.
Install biopsy device mount drape section over biopsy
device mount (item 4). Make sure the three protrusions
and needle guide holder from the biopsy device mount
line up with the respective openings in drape section.
Peel off adhesive under drape flap (item 5) and attach
to bottom of paddle.
Locate previously torn off drape section and insert
between paddle and breast platform to catch fluid
leakage. Peel off adhesive on ends and attach to paddle
and breast platform (item 6).
Install the clear cover (item 7) over the control panel.
When using a lateral needle approach, separate biopsy
drape flap at perforation (item 8).
2: Symbols
This section describes the Symbols on this Drape Set.
Symbol
Description
Symbol
Description
Symbol
Description
Manufacturer
Quantity
Follow operating
instructions
Date of
Manufacture
Batch code
Do not re-use
Catalog number
Authorized representative in
the European community
Non-sterile
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Hologic Affirm Prone Biopsy Equipment Drape Kit Operating instructions

Type
Operating instructions

Hologic Affirm Prone Biopsy Equipment Drape Kit is a sterile, single-use device intended for use during prone breast biopsy procedures. The drape kit helps to maintain a clean and sterile environment during the procedure and helps to prevent contamination of the C-arm assembly. The drape kit consists of three sections: a drape for the breast platform, a drape for the biopsy device mount, and a clear cover for the control panel. The drape for the breast platform has a clear plastic pop-up section to cover the paddle mount.

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