Warnings And Safety Instructions - Medela Invia White Foam Mode D'emploi

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
Invia White Foam is intended to be used in conjunction with the Invia Foam Dressing Kits
with FitPad and the Invia Liberty or Motion Negative Pressure Wound Therapy systems.
Please refer to the specific product instructions 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 limited 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 complica-
tions, 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 completely covered and protected prior to the administration of therapy.
Always ensure that Invia White Foam does 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,
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