Wound Assessment; Safety-Related Checks - Medela Invia Liberty Mode D'emploi

Wound Assessment

CAUTION
Patient Monitoring: The patient should be monitored regularly according to the
physician's instructions and facility guidelines to check for patient comfort, therapy
compliance and signs of infection.
WARNING
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 con si de rable danger to the patient.
Observe wound/periwound tissue and exudate for signs of infection or other complications.
Most common signs of infection include redness, tenderness, fever, swelling, itching,
increased warmth in the wound area, strong odor or purulent discharge. Additional symptoms
include nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of
the mucous membranes, disorientation, high fever (>102° F, 38.8° C), refractory hypotension,
orthostatic hypotension, or erythroedema (a sunburn-like rash). More serious complications
of infection include pain, discomfort, fever, gangrene, toxic or septic shock. If more serious
complications of infection occur, discontinue therapy and consult a physician immediately.

Safety-related Checks

For the safety-related checks, the device should be maintained and repaired throughout its service
life in compliance with the Service procedures.
The Invia Liberty Pump is a device in protection class II (EN IEC 60601-1), the safety-related
checks are confined to visual inspection of the housing and charger for damage. This check must
be performed prior to each use.
Devices of protection class II do not have a protective earth conductor; there is therefore no need
to check the earth leakage current.
The Invia Liberty Pump enclosure is made entirely of insulated material. Tests of the enclosure
leakage current using common measuring instruments will therefore not reveal measurable values.
Even when suctioning a conductive fluid until the overflow protection device activates,
measurements of the patient leakage current using common measuring instruments will not reveal
measurable values.
Invia Liberty Pump does not have patient circuits or functional earth connections.
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