DeRoyal SurgiMate Instructions

SurgiMate Premium Fixed Head
®
Skin Stapler
RX ONLY • NON-STERILE
SINGLE PATIENT USE ONLY • DISPOSABLE
NOT MADE WITH NATURAL RUBBER LATEX
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