Genadyne Biotechnologies | DMR-06-091- Rev F
Indication for use
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.
User
The Genadyne XLR8+ NPWT System is designed for use by licensed healthcare professionals only.
Patients may be trained to perform some limited functions, but the keyboard is locked by the
professional to prevent the patient from changing the settings prescribed by the physician.
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.
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