Warnings And Safety Instructions - Medela Invia Gauze Instrucciones De Uso

Warnings and safety instructions

WARNING
Indicates a potentially hazardous situation which,if not avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.
Safety related tip
Indicating useful information about the safe use of the device.
WARNINGS
The Invia Gauze Dressing Kit with FitPad is intended to be used in conjunction with the Invia Motion and Invia Liberty
Negative Pressure Wound Therapy Systems. Please refer to the specific product instruction for use prior to initiating
therapy.
Bleeding: With or without using therapy, certain patients are at high risk of bleeding complications. The following
types of patients are at an 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 limit-
ed to:
– Suturing of the blood vessel (native anastomosis or grafts)/organ
– Infection
– Trauma
– Radiation
– 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 therapy 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 therapy units and dressings should not be used to prevent, minimize or stop
vascular bleeding.
Protect vessels and organs: All exposed or superficial vessels and organs in or around the wound must be com-
pletely covered and protected prior to the administration of therapy. Always ensure that gauze dressings do not
come in direct contact with vessels or organs. Use of a thick layer of natural tissue should provide the most effective
protection. If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of fine-meshed,
non-adherent material or bioengineered tissue may be considered as an alternative, if deemed by the treating physi-
cian to provide a complete protective barrier. If using non-adherent materials, ensure that they are secured in a man-
ner as to maintain their protective position throughout 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.
Infected blood vessels: Infection may erode blood vessels and weaken the vascular wall which may increase sus-
ceptibility to vessel damage through abrasion or manipulation. Infected blood vessels are at risk of complica-
tions, including bleeding, which, if uncontrolled, could be potentially fatal. Extreme caution should be used
when therapy is applied in close proximity to infected or potentially infected blood vessels. (Refer to protect
vessels and organs section above.)
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