DeRoyal SurgiMate User manual

IMPORTANT
Read carefully and completely before use. These
instructions are a reference for the DeRoyal
SurgiMate Skin Stapler. It is not a guide for
surgical stapling practices. Carefully inspect device
and packaging before use.
INTENDED USE
The DeRoyal SurgiMate Skin Stapler is intended
to be used for skin closure of wounds, incisions
or lacerations of the epidermis. The skin stapler
applies one staple each time the handle is
compressed. The staple points penetrate the skin
and then turn to form a closed staple, which holds
the tissue of the wound line together. The skin
stapler should be used for skin closure only of the
epidermis and is not intended for use within the
body or for deeper layers of the corium (dermis)
or other connective tissue. The skin stapler is
intended for use by a licensed practitioner.
INDICATIONS
The DeRoyal SurgiMate Skin Stapler may
be used for skin closure in a wide variety of
surgical procedures including, but not limited
to, gynecological, orthopedic, cardiovascular,
urological, thoracic and plastic surgery procedures.
PRECAUTIONS
When it is not possible to maintain at least 6.5mm
distance when using staples between the skin
surface and underlying bone, vessels or viscera,
the use of the skin stapler is contraindicated.
DeRoyal intends that non-sterile products for
use in sterile environments be further processed
by our customers, including futher packaging
or sterilization according to their own validated
processes. These products are to be sterilized by
ETO, as other sterilization methods have not been
validated by DeRoyal and may damage the product,
which could cause a device malfunction or injury
to the patient.
CAUTIONS
• Never reuse or sterilize the disposable skin
stapler handle or staples once the package has
been opened. Re-sterilization may compromise
the integrity of the skin stapler.
• Do not attempt to reload staples into the stapler.
• The staples are made of stainless steel and are
not absorbable or dissolvable.
• The skin stapler should be used for skin closure
only of the epidermis and is not intended for
use within the body or for deeper layers of the
corium (dermis) or other connective tissue.
DIRECTIONS FOR USE
1. Approximate the tissue with forceps. Two
forceps may be used to grasp equal portions of
tissue on either side of the wound. The forceps
are pulled together until the tissue edges are
apposed and everted. Hold forceps jaws close
to the stapler jaws for most controllable results.
For tighter staple, grasp and present more tissue
on each edge with forceps. One forceps may be
used to approximate the tissue by grasping a
substantial ridge of centered tissue from both
edges of the wound and closing until the edges
are apposed and everted. Approximation may
be assisted by applying mild traction with skin
hooks at each end of the wound.
2. Gently place the skin stapler jaws on the skin
surface close to the forceps. Align the staple
SurgiMate® Premium Fixed Head
Skin Stapler
RX ONLY • NON-STERILE
SINGLE PATIENT USE ONLY • DISPOSABLE
NOT MADE WITH NATURAL RUBBER LATEX

placement arrow with the center of the wound.
The handle of the stapler should be held at an
angle of approximately 35° to the surface of the
skin.
3. The stapler may be held lightly on the skin or
1 to 2mm slightly above the skin surface if
greater distance between the back span and
tissue surface is desired. Slowly depress the
handle and squeeze the trigger fully until an
audible “click” is heard to place and form the
staple. The SurgiMate design and staple sizing
facilitate visibility of the staple placement. The
staple may be “pre-cocked” in any position or
held in a partially closed position by the internal
mechanism of the stapler.
4. Lift the stapler straight up after each staple
is placed. The stapler releases staples freely
without manual adjustment to disengage the
staples.
5. Repeat steps 1 through 4, placing the staples
approximately 1/4” apart until the entire wound
has been closed. The skin stapler applies one
staple each time the handle is compressed. The
staple points penetrate the skin and then turn to
form a closed staple, which holds the tissue of
the wound line together.
FORMED STAPLE DIMENSIONS
The staples are produced from surgical grade 316L
stainless steel.
STYLE DIMENSIONS DIAMETER
Wide 6.5 mm wide x
4.7mm high
.60mm
Regular 5.7 mm wide x
3.9 mm high
.53 mm
WARNINGS
• It is not necessary to press the skin stapler
into the skin to get the proper “bite.” The skin
stapler should just “kiss” the skin surface or be
raised slightly above the skin surface.
• The skin stapler should be used for skin closure
only of the epidermis and is not intended for
use within the body or for deeper layers of the
corium (dermis) or other connective tissue.
CAUTION: Federal U.S.A. law restricts this device
to sale or use by or on the order of a physician (or
properly licensed practitioner).
WARRANTY
DeRoyal products are warranted for ninety (90)
days from the date of shipment from DeRoyal as
to product quality and workmanship. DEROYAL’S
WRITTEN WARRANTIES ARE GIVEN IN LIEU OF ANY
IMPLIED WARRANTIES, INCLUDING WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
Distributed by:
DeRoyal Industries, Inc.
200 DeBusk Lane, Powell, TN 37849 U.S.A.
888.938.7828 or 865.938.7828
www.deroyal.com
©2015 DeRoyal. All Rights Reserved.
Part # 1109884 Revised 6/15