4
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 Foam 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 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
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 completely
covered and protected prior to the administration of therapy. Always ensure that foam 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 physician to provide a
complete protective barrier. If using non-adherent materials, ensure that they are secured in a manner as to maintain
their protective position throughout therapy. Caution should be taken when treating large wounds that may contain hid-
den 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 suscepti-
bility to vessel damage through abrasion or manipulation.
Infected blood vessels are at risk of complications,
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.)
Hemostasis, anticoagulants and platelet aggregation inhibitors:
Patients without adequate wound hemostasis have
an increased risk of bleeding, which, if uncontrolled, could be potentially fatal. These patients should be treated and
monitored in a care setting deemed appropriate by the treating physician.
Caution should be used in treating patients on doses of anticoagulants or platelet aggregation inhibitors
thought to increase their risk for bleeding (relative to the type and complexity of the wound). Consideration
should be given to the negative pressure setting and therapy mode used when initiating therapy.
