Hardware specs

The Amalgatome SD is a Skin Grafting and Wound Debridement Device

One Device. Multiple Capabilities.

Engineered to deliver the best possible outcomes for burn and trauma patients, the Amalgatome® SD represents a decisive leap forward in skin grafting and wound debridement technology.

The pneumatically powered Amalgatome SD provides effective wound debridement, including removal of necrotic tissue and eschar, as well as being able to produce uniform, consistent skin grafts in thickness ranging from 0.005″ to 0.045″ in increments of 0.001 inches.  All combined into one device.

Amalgatome SD Specifications:

Specification Information
Maximum Graft Width 2-inch Cutting Head: 2 in. (5.08 cm)
4-inch Cutting Head: 4 in. (10.16 cm)
Device Air Consumption 11 cfm
Input Air Pressure and Pneumatic Hose
Information
100 psi, with system running (6.2 bar)
Hospital Grade Air (compressed air, Nitrogen)
Pneumatic Air Hose provided with Schrader-style quick connect female connector and indexed for air
Pneumatic Air Hose coated with an antimicrobial material
Hose Lenth: 15ft
Storage and Transport (Amalgatome SD
System)
As per internal hospital procedure
 Weight and Measurement

 

Assembled 2-inch handpiece: 3.1 lbsAssembled 4-inch Unit: 3.7 lbs
Hand Piece and Pneumatic Hose attached  weight: 4.4 lbs
Complete SDSYSTEM024 in sterilization tray: 17.8 lbs
Weight of Empty Sterilization Tray: 9.7 lbs
Dimensions of the Sterilization Tray: 21 x 10.25 x 4 in.
Sterile, Single-Use Blades Environmental
Conditions
 It is recommended these materials be stored in the provided packaging in a cool (under 32°C [90°F]), clean and dry area.Product sterilized by gamma Irradiation
Biocompatibility results for product on file with Exsurco Medical

Sterilization

The Amalgatome® SD system has only been validated for steam sterilization using the sterilization tray and FDA-cleared wrap. Should any other method or sterilization tray be used, it is the sole responsibility of the facility to validate any sterilization parameters that are not provided directly by the manufacturer. The Amalgatome SD system is provided non-sterile and must be sterilized prior to use.
The wrapped sterilization tray shall be placed inside an autoclave validated in compliance with AAMI ST8:2013, Hospital Steam Sterilizers.
Utilize one of the validated steam sterilization methods listed below to provide a sterility assurance level at a minimum of 12 logarithm population reduction of a microorganism.

 Cycle Type  Pre-vacuum
 Pulses  4
 Set-Point Temperature  135°C/275°F
 Full Cycle Dwell Time  3 minutes
 Dry Time  16 minutes
 Cycle Type  Gravity
 Set-Point Temperature  135°C/275°F
 Full Cycle Dwell Time  10 minutes
 Dry Time  30 minutes