Safety Information; Indications For Use; Contraindications - KCI NPWT Sicherheitshinweise, Anwendungsanweisungen

KCI® NPWT Gauze Dressing
Featuring SensaT.R.A.C.™ Technology
For small and medium wounds
Disposable components of the KCI® NPWT
Gauze Dressing are provided as indicated on
the associated product labeling. V.A.C.® Therapy
Unit canisters are packaged sterile or uid
path sterile and are latex-free. All disposable
components of the KCI® NPWT Gauze Dressing
are for single use only. To help provide safe and
e ective use, the KCI® NPWT Gauze Dressing is
to be used only with the following KCI Therapy
Units: ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™,
V.A.C. Freedom®, V.A.C. ATS®, and V.A.C.Ulta™
Therapy Systems.
Re-use of disposable components may result in
wound contamination, infection and / or failure
of the wound to heal.
Disposables cannot be adequately cleaned
and / or sterilized by the user in order to
facilitate safe use and are therefore intended
for single use. Attempts to clean or sterilize
these devices may result in a biocompatibility,
infection or product failure risks to patient.
The decision to use clean versus sterile /
aseptic technique is dependent upon wound
pathophysiology, physician / clinician
preference, and institutional protocol.
IMPORTANT: As with any prescription medical
device, failure to consult a physician and
carefully read and follow all therapy unit and
dressing instructions and safety 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 treating
physician.

INDICATIONS FOR USE

The KCI® NPWT Gauze Dressing is intended to
be used with the following KCI Therapy Units:
ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™,
V.A.C. Freedom®, V.A.C. ATS® and V.A.C.Ulta™
Therapy Systems. The system is intended to
create an environment that promotes wound
healing by secondary or tertiary (delayed
primary) intention by preparing the wound
bed for closure, reducing edema, promoting
granulation tissue formation and perfusion,
and by removing exudate and infectious
material. Wound types include: chronic, acute,
traumatic, subacute and dehisced wounds,
partial-thickness burns, ulcers (such as diabetic,
pressure or venous insu ciency), aps and
grafts.
KCI® NPWT Gauze Dressing is not intended
for use with instillation therapy, intermittent
therapy or over closed incisions.

CONTRAINDICATIONS

•
The use of negative pressure wound therapy
(NPWT) is contraindicated for:
•
Exposed arteries, veins, organs and nerves
•
Anastomic sites
•
Malignancy in wound (with exception of
palliative care to enhance quality of life)
•
Untreated osteomyelitis
•
Non-enteric and unexplored stulas
•
Necrotic tissue with eschar present
•
Sensitivity to Polyhexamethylene
Biguanide (PHMB) (Kerlix™ AMD™
Antimicrobial)
WARNINGS
Bleeding: With or without using NPWT,
certain patients are at high risk of bleeding
complications. The following types of patients
are at increased risk of bleeding, which, if
uncontrolled, could be potentially fatal:
•
Patients who have weakened or friable
blood vessels or organs in or around the
wound as a result of, but not limited to:
•
Suturing of the blood vessel (native
anastamosis or grafts) / organ
•
Infection
•
Trauma
•
Radiation
SAFETY
INFORMATION
•
Patients without adequate wound
hemostasis;
•
Patients who have been administered
anticoagulants or platelet aggregation
inhibitors;
•
Patients who do not have adequate tissue
coverage over vascular structures.
If NPWT is prescribed for patients who
have an increased risk of bleeding
complications, they should be treated
and monitored in a care setting deemed
appropriate by the treating physician.
If active bleeding develops suddenly
or in large amounts during therapy, or
if frank (bright red) blood is seen in the
tubing or in the canister, immediately
stop therapy, leave dressing in place,
take measures to stop the bleeding and
seek immediate medical assistance.
The V.A.C.® Therapy Units and KCI®
NPWT Gauze Dressings should not
be used to prevent, minimize or stop
vascular bleeding.
•
Protect Vessels and Organs: All exposed
or super cial vessels and organs in or
around the wound must be completely
covered and protected prior to the
administration of therapy.
Always ensure that dressings do not come
in direct contact with vessels or organs.
Use of a thick layer of natural tissue should
provide the most e ective protection. If a
thick layer of natural tissue is not available
or is not surgically possible, multiple layers
of meshed, non-adherent material or bio-
engineered tissue may be considered as
an alternative, if deemed by the treating
physician to provide a complete protective
barrier. If using non-adherent materials,
ensure they are secured in a manner that
will maintain their protective position
throughout therapy.
Consideration should also be given to the
negative pressure setting and therapy
mode used when initiating therapy.
Caution should be taken when treating
large wounds that may contain hidden
vessels which may not be readily apparent.
The patient should be closely monitored
for bleeding in a care setting deemed
appropriate by the treating physician.
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