Intended Use; Contraindications; Device Description; Warnings - KCI CelluTome Système de prélèvement de cellules épidermiques Manuel D'utilisation

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.
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.

WARNINGS

The harvester is a disposable component and is intended for single use only. Re-use of disposable
components may result in contamination and infection.

PRECAUTIONS

Inspect the CelluTome™ Epidermal Harvesting System before use for signs of visible damage. Do not use if
there are any indications of damage.
Harvest from areas of healthy intact skin (donor site).
Actuating the harvester handle prior to complete microdome formation may result in patient pain and / or
bleeding.
Nest
Harvester
Microdome Grid
11
Vacuum Head