Warnings / Safety Instructions - Medela Invil Liberty Mode D'emploi

Warnings / Safety instructions

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Invia Liberty is approved exclusively for the use described in these instructions for use. Medela
can only guarantee the safe function of the system, if Invia Liberty is used in combination with
the original Medela accessories (disposable canister, tubing set, carrying bag, power cord,
docking station).
Invia Liberty is EMC-tested in conformity with the requirements of IEC 60601-1-2:2001 and
can be used in the vicinity of other EMC-tested devices that fulfil the requirements of the rele-
vant IEC 60601-1-2 standard. Untested HF sources, radio networks or the like can influence
the operation of the device and may not be operated in combination with Invia Liberty.
Please read and observe these warning and safety instructions before operation.
Warnings
• This manual provides general guidelines for the use of the Invia Wound Therapy.
• However, the safe and effective operation of this device requires specific instruction from
physician.
• For use only by medically trained persons who have been adequately trained in suction
procedures, wound care, negative pressure wound therapy and in the use of aspirators.
Caution: Incorrect use can cause pain and injury to the patient.
• Consult the indications for use, precautions and contraindications when using the Invia
Liberty as a vacuum source with the Invia Wound Therapy. Failure to read and follow all
instructions in this manual prior to use may result in serious or fatal injury of the patient.
• Failure to obtain consent and any additional instructions from the treating physician prior to
use, may lead to serious or fatal injury of the patient
• Before you plug in the device, please check that your local power supply is the same as the
voltage given on the specification plate.
• The device is not for use while bathing, showering or suitable for a hazardous explosive
environment.
• Do not use Invia Liberty in Magnetic Resonance Imaging (MRI) or Positron Emission
Tomography (PET).
• Clamp the drain and disconnect Invia Liberty pump prior to patient entering hyperbaric
oxygen chamber.
• Do not dry Invia Liberty with microwaves.
• Invia Liberty is protected against the penetration from solid/fluid substances by a hydropho-
bic filter. If this filter fails, Invia Liberty must be replaced.
• Data transfer via USB is not possible in the running mode.
• Serious or fatal injury can result from bone fragments or sharp edges (e.g., staples or hard-
ware) that could puncture protective barriers, vessels, or organs.
• Please consider using a protective barrier where drain tubing comes in contact with pati-
ents with fragile or pliable skin.
• NPWT should not be interrupted for more than 120 minutes at a time, because this may
lead to increased bacteria and a higher risk of infection.
• Patients undergoing NPWT need frequent supervision. Objective indications or signs of
a possible infection of the patient or complication must be met immediately, such as e.g.
fever, pain, redness, increased warmth, swelling or purulent discharge.
• Excessive vacuum, a too tight adhesive dressing or an infection of the wound can cause
the patient pain. In each case the dressing must be changed and the wound inspected in
detail.
• Special care is advised for gauze placement and removal in order to avoid situations such
as unintentional gauze retention.
Contact your local Medela customer service representative for assistance with product opera-
tions.
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