Amalgatome SD - SDSYSTEM024 - Skin Grafting and Wound Debridement Device (Reusable Device)

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.

Studies on file demonstrating the Amalgatome SD:

  • Provides superior graft quality
  • More consistent thickness for excised necrosis tissue and skin grafts
  • A better relationship between the set depth of excision and actual depth
  • Overall ease of use and assembly compared to standard technology
Watch SD Demo Video
Clinical Evidence

Innovative Circular Design

  • High-speed rotating excision ring cuts through tissue quickly and efficiently compared to conventional methods
  • Round design allows device to move over contoured areas of the body
  • Continuous operation for multiple uses throughout the procedure with no rest intervals between uses.
  • Allows for more efficient multiple graft harvest or debridement passes

Advanced Ergonomics

  • Easy operation minimizes repetitive movements to help reduce hand fatigue
  • Requires minimal force to operate
  • Comfortable slide lever handle ideal for maneuvering along the body contour

Depth Control

The Amalgatome SD allows the user to adjust the thickness from 0.005" to .045" in 0.001" increments.   The depth adjustment dial is located on top of the device for easy control and quick adjustment during the procedure.

Proven Results

  • Live animal study conducted indicating the Amalgatome SD is safe for performing skin grafting and wound debridement procedures on patients (Study on file)
Visual Window
  • The design of the graft recovery area allows for immediate view of graft quality and thickness
  • Allows the user to see surgical site during the procedure with an uninterrupted site line
Durable Components
  • Minimal parts required for assembly and use
  • Pneumatic motor provides ongoing reliability and minimal downtime for continuous use and limited maintenance
  • No calibration required.  Self-contained device with no maintenance required by customer
  • Reusable 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 lbs Assembled 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
 

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