Intended Use; Device Description - KCI Cellutome Instructions For Use Manual

INTENDED USE

The CelluTome™ Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for
autologous skin grafting.
CONTRAINDICATIONS
None

DEVICE DESCRIPTION

The reusable components of the CelluTome™ Epidermal Harvesting System:
Control Unit
•
The control unit creates and regulates the vacuum and monitors the vacuum head.
•
The vacuum head and tubing deliver the vacuum from the control unit and creates the warming
required to raise the epidermal suction microdomes.
NOTE:
More information about the control unit and vacuum head can be found in the CelluTome™
Epidermal Harvesting System User Manual.
The disposable component of the CelluTome™ Epidermal Harvesting System:
The harvester holds the suction microdomes that are raised for procurement. A 3M™ Tegaderm™ Film
(catalog number: 1624W) is placed onto the harvester's microdome grid prior to cutting the microdomes.
After cutting the microdomes, the 3M™ Tegaderm™ Film with the micrografts is then applied to the
recipient site.
Follow warnings, precautions and instructions listed in this document. Improper use could result in
patient injury, bleeding, scarring, inadequate micrografts, prolonged procedure time, incomplete or
ineffective procedure, the need to perform harvesting at a second donor site or patient discomfort.
Harvester
2
Vacuum Head