Exsurco Medical SDSYSTEM024 Amalgatome SD System w/ Sterilization Case

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

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 d epth 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 32C [90F]), clean and dry area. Product sterilized by gamma irradiation Biocompatibility results for product on file with Exsurco Medical

SterilizationThe 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 135C/275F Full Cycle Dwell Time 3 minutes Dry Time 16 minutes Cycle Type Gravity Set-Point Temperature 135C/275F Full Cycle Dwell Time 10 minutes Dry Time 30 minutes

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Additional Services Offered

Liquidation Services

Whether you need to sell one piece, or an entire facility, has the resources and contacts to liquidate your equipment quickly and get you the cash you need.

Consignment Services

If you have equipment which is no longer in use and is taking up valuable space, can pick up your unwanted items and sell them for you on a consignment basis. Our rates are the lowest in the industry and this truly is the best way to get the most money for your items.

Surplus Asset Management (SAM) Program

This is s Signature Program! We handle all of your surplus equipment needs, from inventory and tracking, to pick-up, storage, and sale. This extremely flexible program can be custom-fit to your specific needs, so contact us today to schedule your custom SAM Program presentation.

ASC Equipment Planning Services

Dont spend the tens of thousands of dollars on an overpriced consulting company, has the experience and know-how to help you every step of the way when you are planning the equipment for your new office, surgery center, or hospital.

The sale of this item may be subject by the U.S. Food and Drug

Administration and state and local regulatory agencies. If so, do not

buy this item unless you are an authorized purchaser. If the item is

subject to FDA regulation, I will verify your status as an authorized

purchaser of this item before shipping of the item. Any used product

has been cleaned/sterilized per manufacturers specifications.