Exsurco Medical Amalgatome SD User manual

Amalgatome®SD
User Guide
EXSURCO MEDICAL
10804 GREEN ROAD
WAKEMAN, OH 44889
PN: X101456 REV. C

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AMALGATOME®SD USER GUIDE
Instructions for Use
Exsurco Medical
10804 Green Road
Wakeman, OH 44889
1-800-243-6049
www.exsurco.com
NOTICE TO USERS
Read this manual thoroughly before using the Exsurco Medical Amalgatome SD System. It is designed for use by
qualified and trained medical professionals where the patient is under supervision of trained personnel. Review
this user guide, paying particular attention to all warnings and precautions, prior to any surgical procedure.
Improper system set up and operation or failure to follow this user guide can cause injury or damage that is not
covered under the warranty.

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Table of Contents
Preface........................................................................................................................................................................3
Purpose...................................................................................................................................................................3
Exsurco Medical.....................................................................................................................................................3
Contact Information................................................................................................................................................3
System Overview........................................................................................................................................................5
Indications for Use .................................................................................................................................................5
Description .............................................................................................................................................................5
Components............................................................................................................................................................6
How Supplied.........................................................................................................................................................7
Contraindications....................................................................................................................................................8
General Warnings and Precautions ............................................................................................................................9
Warnings ................................................................................................................................................................9
Precautions .............................................................................................................................................................9
Setup Instructions.................................................................................................................................................... 11
Inspection ............................................................................................................................................................ 11
Setup.................................................................................................................................................................... 11
System Check.......................................................................................................................................................... 15
Depth Gauge Setting............................................................................................................................................ 16
Operating Instructions............................................................................................................................................. 17
Graft Harvesting and Debridement ..................................................................................................................... 17
Postoperative Procedure...................................................................................................................................... 20
Cleaning and Sterilization Instructions.................................................................................................................... 23
Manual Cleaning of the Sterilization Tray.......................................................................................................... 24
Automated Cleaning of the Sterilization Tray..................................................................................................... 24
Manual Cleaning of the Reusable System........................................................................................................... 26
Automated Cleaning of the Reusable System ..................................................................................................... 29
Visual Inspection................................................................................................................................................. 30
Sterilization Preparation...................................................................................................................................... 31

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Sterilization ......................................................................................................................................................... 32
Troubleshooting....................................................................................................................................................... 33
Warranty, Service, and Returns............................................................................................................................... 38
Limited Warranty ................................................................................................................................................ 38
Service................................................................................................................................................................. 39
Returns................................................................................................................................................................. 39
Appendix A: Technical Specifications.................................................................................................................... 42
Specifications ...................................................................................................................................................... 42
Appendix B: Parts Information ............................................................................................................................... 44
Ordering Information........................................................................................................................................... 46
Appendix C: Glossary of Symbols.......................................................................................................................... 48
Appendix D: Quick Reference Guides.................................................................................................................... 50
Setup.................................................................................................................................................................... 50
Postoperative Procedure...................................................................................................................................... 51
Manual Cleaning of the Reusable System........................................................................................................... 52
Appendix E: External References for Sterilization and Details of Validation Report ............................................ 54
Help Information..................................................................................................................................................... 56

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Preface
Purpose
This user guide provides directions to help users safely and effectively operate the Amalgatome SD System. This
guide also includes material such as indications for use, contraindications, and troubleshooting information.
Exsurco Medical
Exsurco Medical’s mission is to redefine excision science across the continuum of care through delivery and
advancements in clinical solutions, strategic healthcare partnerships, and deep customer understanding. We are
committed to improving patients’ lives and outcomes by advancing the healing power of skin through innovation,
product development, and the marketing of medical devices for healthcare professionals in the surgical and tissue
bank markets.
The Amalgatome SD is designed to excise tissue utilizing an innovative excision ring blade technology and is
indicated for skin grafting and wound debridement. This new advancement and design incorporates the ability to
excise tissue with one device in a precise and efficient manner.
Contact Information
Contact Exsurco Medical at 1-800-243-6049 or via e-mail at [email protected]m.

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System Overview
This section provides general information about the Amalgatome SD System.
Indications for Use
The Amalgatome SD System is designed to excise soft tissue in varying widths and thicknesses for skin grafting
and wound debridement. It is indicated for open wounds, including wound site preparation (debridement and
sharp debridement), removal of necrotic tissue and eschar, and tissue harvesting (autograft harvesting).
Description
The Amalgatome SD System is a pneumatically powered surgical skin grafting instrument capable of producing
varying thicknesses of skin grafts from 0.005 to 0.045 inches in increments of 0.001”. Single-use disposable,
excision ring blades provide precision cutting and are available in 2-inch and 4-inch diameters, depending on the
size of the graft needed or debridement site.
The Amalgatome SD is also capable of soft tissue excision (removal of necrotic tissue and eschar) and wound site
preparation of the surgical site in applications (acute, chronic wounds, and burns) that in the physician’s clinical
judgment require debridement and sharp debridement.

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Components
Figure 1. Components
1. Pneumatic hose
2. 4-inch Lock Ring
3. 4-inch Cutting
Head (excision
ring blade head)
4. 2-inch Cutting
Head (excision
ring blade head)
5. 2-inch Lock Ring
6. Hand Piece (Drive
Unit)
7. Lock Nut Wrench
8. Lock Ring
Removal Tool
Disposable
Excision ring
blades, 2-inch and
4-inch (sold
separately, not
shown) and
sterilization Tray
(not shown)
For additional part
number information,
refer to Appendix B:
Parts Information.
7
8
2
1
3
4
5
6

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How Supplied
•The Amalgatome SD System consists of the following components as shown on previous page:
oHand Piece (Drive Unit): Consists of the motor and pneumatic hose which powers the system.
oInterchangeable cutting heads with lock ring and assembly accessories.
oThe single-use disposable surgical excision ring blades are supplied separately.
•The complete system is shown and is sold with the custom-made sterilization tray, which should be utilized
with this system only.
oSDSYSTEM024 contains the 2-inch and 4-inch cutting heads.
oSDSYSTEM04 contains the 4-inch cutting head.
oSDSYSTEM02 contains the 2-inch cutting head.
•The system is provided non-sterile and is reusable after cleaning and sterilization prior to use according to the
procedures outlined in this document.
•Each piece of the system is shipped individually contained in protective suspension or retention boxes and
each must be opened, visually inspected, cleaned and then placed in the sterilization tray for sterilization.
•The single-use, disposable excision ring excision ring blades are provided sterile and should be considered
sterile unless the sterile packaging has been opened or damaged.
WARNING: Re-sterilization or reuse of the disposable excision ring blades can result in serious physical
harm to the patient. Excision ring blades are for single use and must not be reused.

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Contraindications
The Amalgatome SD System is not recommended for use on the following locations on the body or where
surgeon determines due to health reasons:
•Eyelid(s)
•Post auricular region (behind the ear) and on the ear
•Inguinal region (groin)
•Genital region
•Forearm (underside of wrists up to the elbow)
•Supraclavicular area (above the collarbone)

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General Warnings and Precautions
This section provides general warnings and precautions about the Amalgatome SD System.
Warnings
•The user of the Amalgatome SD System must be a surgically trained professional (e.g., a surgeon) and
thoroughly familiar with the function, application, and instructions for use in order to avoid injury to the
patient and operating staff.
•Each physician must evaluate the appropriateness of the technique for each patient based on his or her own
medical training and expertise. Care should be taken in treating individuals with pre-existing conditions that
might affect the success of the surgical procedure. Every patient is different and results can vary.
•This device can cut soft tissue. Apply only to tissues and debris intended to be excised from the wound.
•Only use the Amalgatome SD sterile, disposable, excision ring excision ring blades with the Amalgatome SD
System.
•Do not use excision ring blades from other manufacturers.
•Do not reuse the excision ring blades as they are intended for single use. Serious injury can result from use of
other manufacturer’s excision ring blades or reuse of the Amalgatome SD excision ring blades. Dispose of the
excision ring blades in accordance with facility protocol for sharps containment.
•Sharpening of the excision ring blade or removal of excision ring blade material will result in loss of
calibration.
•Care should be taken when removing the excision ring from its packaging. The excision rings are extremely
sharp.
Precautions
•The Amalgatome SD System operator and other clinical personnel should follow the universal protocol for
aseptic technique as with all surgical procedures.
•As with all surgical procedures, the surgical team and clinical personnel should follow the universal
precautions for infection control. (including the use of surgical gloves, facemask that covers the mouth and
nose, protective eye wear or shield, protective clothing and anti-slip shoe covers.) Especially during
debridement procedures due to possible tissue spray
•It is recommended prior to clinical use of the Amalgatome SD System, that all operators of the system be
trained in its proper use. Contact your local Exsurco Medical Sales Representative for all details regarding
Amalgatome SD training.
•United States of America (USA) federal law restricts this device to sale by or on the order of a physician.

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Setup Instructions
This section describes how to inspect and set up the Amalgatome SD System prior to each use.
Perform the following procedures before each use. Follow sterile field aseptic technique per the Association of
periOperative Registered Nurses (AORN) guidelines and hospital protocol. Open, inspect, and set up the sterile
Amalgatome SD and disposable excision ring blades within the sterile field.
Inspection
1. Inspect the disposable excision ring blade for possible damage, wear, or defects. Ensure that the excision ring
blade is free of particulate and burrs. Discard the excision ring blade if it is damaged or defective.
2. Inspect all movable parts in order to ensure that the parts function through the intended range of motion.
Do not use or reprocess damaged or defective parts. If the system does not function correctly, contact Exsurco
Medical Customer Service at 1-800-243-6049, ext. 4, or email [e-mail] for repair or
replacement.
3. Inspect the O-ring on the hand piece of the device. Wear on the O-ring is expected. During the annual
preventative maintenance program the O-ring will be replaced. Do not use if the O-ring is cut or severed in
half, or missing. Do not attempt to replace the O-ring.
Setup
Refer to Appendix D: Quick Reference Guide for a pictorial reference to this procedure.
1. Assemble the cutting head onto the hand piece.
Figure 1a
a. Hold the hand piece in the upright position, with the
protruding gear facing upward and the ON/OFF lever
facing the user.
Figure 1b
b. Align key slot on the handle onto the pin on the head of
the system.

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Figure 1c
c. Hand-tighten the locking knob clockwise until it stops;
do not over tighten.
Figure 1d
d. Adjust the depth gauge to the preferred operating setting.
2. Open and install the disposable excision ring blade.
Figure 2a
a. Check the package integrity and the expiration date.
Figure 2b
b. Using the peel-pack end with peel corners, pull open the
package, allowing the sterile operator to reach in and
grab the clamshell. WARNING SHARP
NOTE:It is best practice to have the package opened
for the sterile operator. It also best practice not to open
the excision ring blade or change the excision ring
blade over a patient.
Figure 2c
c. Open the clamshell containing the excision ring blade –
(similar to opening a book – right to left), following the
THIS SIDE UP arrow.
Figure 2d
d. Fold the left (empty) side of the clamshell under the
excision ring blade side, and then turn the clamshell
over.

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Figure 2e
e. While standing close to the table or sterile surface, use
the thumb notches on the tray to release the excision
ring blade out of the clamshell onto the sterile surface.
CAUTION: At this time the excision ring blade is
lying teeth side down on the sterile surface. Do not
touch the inner ring of the excision ring blade. It is the
sharp cutting surface.
Figure 2f
f. Hold the outer edge of the excision ring blade by
grasping the blue strip and load the excision ring blade
into the hand piece. While nesting the excision ring
blade, turn its outer edge slightly in order to ensure
proper seating.
Figure 2g
g. Place the excision ring blade lock ring over the excision
ring blade and twist it in a clockwise motion until it
stops. Do not over tighten.
3. Attach the pneumatic hose.
Figure 3a
Figure 3b
a. Connect the female end of the pneumatic
hose to the male end of the hand piece,
securing with the twist-lock feature.
b. Lubricate the O-ring prior to connecting the
air hose with sterile mineral oil. This will
help make the female end of the air hose
easier to attach to the male end of the hand
piece using the toggle barbs. Do not bend
hose at a 90o angle at the connection site.
Do not use excessive force during the
process.
Figure 3c
c. Grasp the hose and attach the hose to the
swivel connector on the hand piece. Turn the
hose clockwise to secure.
NOTE: If the connection seems difficult to
attach it is acceptable to place a few drops of

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sterile mineral oil on the O-ring to help
engage the connection.
NOTE: Use caution not to drop the hose
prior to assembly.
Figure 3d
d. Pass the other end of the pneumatic hose to
the circulator. Using a non-perforated
holder, clip or secure the pneumatic hose to
the sterile field, taking care not to compress
the hose.
Figure 3e
e. Connect the male end of the pneumatic hose
to the appropriate air source in the operating
room designated for the procedure.
NOTE: The male end of the hose connects
to a Schrader®style quick connect female
coupler indexed for air.
f. Turn on the air or gas supply, and then verify the pressure while the system is running.
CAUTION: Use hospital grade compressed air or nitrogen at the recommended setting of 100 psi.

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System Check
This section describes the process for checking the system and setting the depth gauge.
NOTE: This process must be performed over a sterile surface.
Figure 1
1. Slide the ON/OFF lever on the hand piece to the
ON position.
Figure 2
2. Press down on the ON/OFF lever to activate the
system. It is now ON.
When the system activates, the disposable
excision ring blade spins.
3. Verify that all connections are secure and that
the air pressure is set correctly while the system
is running.
NOTE: The required air pressure setting is 100
psi.
Figure 4
4. Release the ON/OFF lever, and then slide it to
the OFF position.
The system deactivates and the disposable
excision ring blade stops spinning. The system is
now ready to be used for the procedure.
CAUTION: Always pass the hand piece from one person to another with the ON/OFF lever in the OFF position.
Do not grab or pass the hand piece by the cutting head due to the risk of contact with the excision ring blade.

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Passing the Hand Piece
Depth Gauge Setting
The settings on the depth adjustment knob indicate increments of 0.001 inches (0.0254 mm) and cover a range of
0.005 to 0.045 inches (0.127 to 1.143 mm).
The depth gauge settings are a guide only and the resulting skin graft is dependent upon the individual patient
demographics (e.g. age, weight, ethnicity, etc.).
Rotate the depth adjustment knob to the left (counterclockwise) for thinner settings and to the right (clockwise)
for thicker settings. The depth gauge setting can be changed at any time during the procedure.
Setting the Depth Gauge
CAUTION: Do not disassemble the depth gauge. The gauge can lose calibration and must be returned to Exsurco
Medical for recalibration. Never remove the screws or components on the gauge knob for cleaning or sterilization.
They must always stay intact.