Indications For Use; Contraindications; Warnings And Safety Instructions - Medela Invia Mode D'emploi

Indications for use

The Invia Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall open-
ings where primary closure is not possible and/or repeat abdominal entries may be required.
Its intended use is with patients who have open abdominal wounds with exposed viscera and
organs, and including but not limited to patients with abdominal compartment syndrome. It is
intended for use in acute hospital settings (trauma, general and plastic surgery wards) and
should ideally be applied in the operating theatre. The dressing kit is intended for use together
with the Invia Liberty NPWT System.

Contraindications

– Direct positioning of NPWT foam over exposed organs, large veins and arteries, anasto-
motic sites, tendons or nerves (unless suitably covered with the Organ Contact Layer)
– Necrotic tissue with eschar present
– Untreated osteomyelitis
– Non-enteric and unexplored fistulas
– Malignancy in wound

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 Abdominal Dressing Kit is intended to be used in conjunction with the Invia Liberty
Negative Pressure Wound Therapy system.
– Please refer to the Invia Liberty Negative Pressure Wound Therapy system product instruc-
tions for use prior to initiating therapy.
Use of Organ Contact Layer (OCL):
– Use of the OCL is necessary to protect exposed bowels from the abdominal wall and from
contact to the foam. Preventing adhesions or obstructions that may otherwise form during
open abdominal wound management is a critical parameter in achieving timely primary facial
closure and reducing the chance of fistula development.
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