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Genadyne XLR8 - Indication for Use; Contraindications; CAUTION: Direct Contact Warnings; Precautions

Genadyne XLR8
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GenadyneBiotechnologies|EN(V5.0909.1) 6
Indicationforuse
The Genadyne XLR8 Wound Vacuum System is indicated for use in patients who would benefit from
negative pressure wound therapy particularly as the device may promote wound healing by the
removal of excess exudates, infectious material and tissue debris.
Contraindications
Genadyne XLR8 Therapy is contraindicated for patients with:-
o Malignancy in the wound
o Untreated osteomyelitis (NOTE: Refer to Clinical Guide for Osteomyelitis information.)
o Non-enteric and unexplored fistulas
o Necrotic tissue with eschar present (NOTE: After debridement of necrotic tissue and complete
removal of eschar, Genadyne XLR8 Therapy may be used.)
CAUTION:
Do not place dressing directly in contact with:-
o Exposed blood vessels
o Anastomotic sites
o Organs
o Nerves
NOTE: Refer to Clinical Guide for additional information concerning Bleeding.
Precautions
Precautions should be taken for patients who are or may be: receiving anticoagulant therapy,
suffering from difficult hemostasis, untreated for malnutrition and non-compliant or combative.
StandardPrecautions
To reduce the risk of transmission of blood borne pathogens, apply standard precautions for infection
control with all patients, per institutional protocol, regardless of their diagnosis or presumed infection
status. In addition to gloves, use gown and goggles if exposure to body fluid is likely.
ContinuousversusIntermittentTherapy
Continuous, rather than intermittent, Genadyne XLR8 Therapy is recommended over unstable
structures, such as an unstable chest wall or non-intact fascia, in order to help minimize movement
and stabilize the wound bed. Continuous therapy is also generally recommended for patients at
increased risk of bleeding, highly exudating wounds, fresh flaps and grafts, and wounds with acute
enteric fistulae.

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