Warnings And Safety Instructions; Warnings - Medela Invia Motion Mode D'emploi

Warnings and safety instructions

WARNINGS

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTIONS
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.
The Invia Motion Negative Pressure Wound Therapy system is intended for use as described in these
instructions for use.
Medela is only responsible for the effect on BASIC SAFETY, reliability and performance of the Invia Motion
NPWT system if it is used in accordance with the instructions for use.
Please read and observe these warnings and safety instructions before operation.
These instructions for use must be kept with the device.
Please note that these instructions for use are a general guide for the use of the product. Medical situations
must be addressed by a physician.
Warnings
WARNINGS
– Do not modify this equipment without authorization from the manufacturer.
– Consult the indications for use, contraindications, warnings and cautions before using the Invia
Motion NPWT pump as a negative pressure source with the Invia foam and gauze dressings. Failure
to read and follow all instructions in this manual prior to use may result in serious or fatal injury of
the patient.
– Invia wound therapy Instructions advise 24 hours therapy per day without interruption. If therapy
is discontinued for more than 2 hours, the dressing should be replaced and therapy restarted
by a healthcare professional.
– Unplug the pump before cleaning.
– Do not use accessories other than those specified or sold by the manufacturer as replacement
parts for internal components as it may result in increased electromagnetic emissions or decreased
electromagnetic immunity of the Invia Motion NPWT pump.
– The Invia Motion NPWT system should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the Invia Motion NPWT system should be observed to verify
normal operation in the configuration in which it will be used.
– The Invia Motion NPWT pump is intended for a single patient's entire therapy. Reuse on another
patient might cause cross contamination.
– Patients must be closely monitored for bleeding. If sudden or increased bleeding is observed,
immediately stop use of the pump, apply pressure and seek immediate emergency medical
attention.
– Objective indications or signs of a possible infection or complication must be addressed immediately
(e.g. fever, pain, redness, increased warmth, swelling or purulent discharge). Non-observance can
lead to considerable danger to the patient.
– When using the Invia Motion NPWT system in close proximity to blood vessels, organs, nerves,
tendons or ligaments a protective barrier, such as a non-adherent contact layer, must be used.
– Serious or fatal injury can result from bone fragments or sharp edges (e.g. staples or hardware) that
could puncture protective barriers, vessels or organs.
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