Device Dossier
Sunmedic Viverex PD 1600100 - Negative-pressure wound therapy system, battery-powered, single-use
Device Dossier for Sunmedic Viverex PD 1600100 - Negative-pressure wound therapy system, battery-powered, single-use (Negative-pressure wound therapy…
Intended purpose
Negative pressure wound therapy system, battery operated, disposable is a medical therapeutic device which applies controlled negative pressure to the wound bed and is intended to be used for ten days for one patient, which means no risk for cross contamination. Applying negative pressure results in transferring wound exudate to the NPWT dressing. The NPWT dressing contains of 5 layers and is designed to manage the wound exudate in two different mechanisms, by which VivereX™ system increases dramatically the dressing life time: • The absorbent layer of the dressing absorbs some of the secretion. • The dressing allows evaporation of the rest of the wound secretion VivereX™ system is suitable for use in both hospital and home care setting. Wound types which is appropriate includes: 1. Acute wound 2. Chronic wound with small or medium secretion 3. Skin graft or flaps and donator site 4. Pressure ulcers 5. Diabetics ulcers 6. Surgical clean closed incision 7. Subacute dehisced wounds 8. Trauma wounds 9. Burn injury grade I and II