KCI ABThera Instrucciones De Uso página 5

ABThera
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Active Abdominal Therapy
SAFETY INFORMATION
IMPORTANT: As with any prescription medical device, failure to consult a physician and
carefully read and follow all ABThera
information prior to each use may lead to improper product performance and the potential
for serious or fatal injury. Do not adjust therapy unit settings or perform therapy application
without directions from / or supervision by the clinical caregiver.
All disposable components of the ABThera
disposable components may result in wound contamination, infection and / or failure of
the wound to heal.
INDICATIONS FOR USE:
• The ABThera ™ (NPT) System is indicated for temporary bridging of abdominal wall
openings where primary closure is not possible and / or repeat abdominal entries are
necessary. The Intended Use of this system is for use in open abdominal wounds, with
exposed viscera, including but not limited to abdominal compartment syndrome.
• The ABThera (NPT) System is intended for use in the acute hospital setting: in trauma,
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general and plastic surgery wards. The abdominal dressing will most often be applied in
the operating theater.
CONTRAINDICATIONS:
• Patients with open abdominal wounds containing non-enteric unexplored fistulas should
not be treated with the ABThera
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• Protect vital structures with ABThera
therapy. Never place exposed foam material directly in contact with exposed bowel,
organs, blood vessels or nerves.
Management of the open abdomen has been documented in case reports and consensus
panel literature. Please refer to the References List section at the end of the dressing
application instructions.
Bleeding: Patients with abdominal wounds must be closely monitored for bleeding
as these wounds may contain hidden blood vessels which may not be readily
apparent. If sudden or increased bleeding is observed in the dressing, tubing
or canister, immediately turn off the ABThera
measures to stop bleeding, and contact the physician. The ABThera
is not designed to prevent, minimize or stop bleeding.
Hemostasis must be achieved prior to dressing placement.
INSTRUCTIONS FOR USE
OPEN ABDOMEN
NEGATIVE PRESSURE THERAPY SYSTEM
( NPT) Unit and dressing instructions and safety
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™ (NPT) System are for single use only. Re-use of
(NPT) System.
Visceral Protective Layer at all times during
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WARNINGS WARNINGS
(NPT) System, take appropriate
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The following conditions may increase the risk of potentially fatal bleeding.
• Suturing and / or Anastamoses
• Trauma
• Radiation
• Inadequate wound hemostasis
• Non-sutured hemostasic agents (for example, bone wax, absorbable gelatin sponge
or spray wound sealant) applied in the abdomen may, if disrupted, increase the risk of
bleeding. Protect against dislodging such agents.
• Infection in the abdominal wound may weaken visceral organs and associated
vasculature, which may increase susceptibility to bleeding.
• Use of anticoagulants or platelet aggregation inhibitors.
• Bone fragments or sharp edges could puncture vessels or abdominal organs. Beware
of possible shifting in the relative position of tissues, vessels or organs within the
abdominal wound that might increase the possibility of contact with sharp edges.
Intra-abdominal Pressure Monitoring: Laparotomy with the placement of a temporary
abdominal closure does not eliminate the possibility of elevation in intra-abdominal
pressure (IAP). When using the ABThera
diagnostic signs and symptoms of elevated IAP) should continue as indicated by patient
condition, in accordance with institutional clinical practice or guidelines. If intra-abdominal
hypertension (IAH) or abdominal compartment syndrome (ACS) is observed, note intra-
abdominal pressures and turn off power to the ABThera
negative pressure. After full expansion of the perforated foam, obtain new intra-
abdominal pressure measurement. If IAH / ACS persists without negative pressure (and
collapse of midline perforated foam), discontinue the use of ABThera
address the underlying condition as medically indicated. If IAH / ACS resolves or improves
without negative pressure (and collapse of midline perforated foam), consider providing
ABThera Therapy without medial tension (refer to Perforated Foam Application).
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Use of Visceral Protective Layer: When using the ABThera
the Open Abdomen Visceral Protective Layer completely covers all exposed viscera and
completely separates the viscera from contact with the abdominal wall. Place the Visceral
Protective Layer over the omentum or exposed internal organs, and carefully tuck it
between the abdominal wall and internal organs, making sure the Visceral Protective Layer
completely separates the abdominal wall from the internal organs.
Adhesions and Fistula Development: Formation of adhesions of the viscera to the
abdominal wall may reduce the likelihood of fascial reapproximation and increase the risk
of fistula development, common complications in patients with exposed viscera.
Infection: Infected abdominal wounds should be monitored closely and may require more
frequent dressing changes than non-infected wounds, dependent upon factors such as
patient condition, wound condition and treatment goals. Refer to dressing application
instructions for details regarding dressing change frequency.
Dressing Placement: Always use an ABThera
(NPT) System not been opened or damaged. Do not force any dressing component into the wound, as
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this may damage underlying tissue.
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™ (NPT) System, IAP monitoring (for clinical or
(NPT) System, discontinuing
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™ (NPT) System and
(NPT) System, ensure that
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Dressing from a sterile package that has
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