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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SD USER GUIDE
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
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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
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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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SD USER GUIDE
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 Med ical
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.
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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 support@exsurco.com.
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System Overview
This section provides general informati on 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.
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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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1. Pneumatic hose
Parts Information.
7
8
2 1 3
4
5
6
Components
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Figure 1. Components
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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:
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How Supplied
• The Amalgatome SD System consists of the following components as shown on previous page:
o Hand Piece (Drive Unit): Consists of the motor and pneumatic hose which powers the system.
o Interchangeable cutting heads with lock ring and assembly accessories.
o The 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.
o SDSYSTEM024 contains the 2-inch and 4-inch cutting heads.
o SDSYSTEM04 contains the 4-inch cutting head.
o SDSYSTEM02 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 protect iv e 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.
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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 e x cision 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.
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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 co v ers. ) 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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Figure 1a
a. Hold the hand piece in the upright position, with the
Figure 1b
b. Align key slot on the handle onto the pin on the head of
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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 Asso ciation 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 support@exsurco.com 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.
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Setup
Refer to Appendix D: Quick Reference Guide for a pictorial reference to this procedure.
1. Assemble the cutting head onto the hand piece.
protruding gear facing upward and the ON/OFF lever
facing the user.
the system.
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Figure 1c
c. Hand-tighten the locking knob clockwise until it stops;
Figure 1d
d. Adjust the depth gauge to the preferred operating setting.
Figure 2a
a. Check the package integrity and the expiration date.
b. Using the peel-pack end with peel corners, pull open the
Figure 2c
c. Open the clamshell containing the excision ring blade –
Figure 2d
d. Fold the left (empty) side of the clamshell under the
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2. Open and install the disposable excision ring blade.
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do not over tighten.
Figure 2b
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.
(similar to opening a book – rig ht to le f t), following the
THIS SIDE UP arrow.
excision ring blade side, and then turn the clamshell
over.
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e. While standing close to the table or sterile surface, use
Figure 2f
f. Hold the outer edge of the excision ring blade by
Figure 2g
g. Place the excision ring blade lock ring over the excision
a. Connect the female end of the pneumatic
Figure 3c
c. Grasp the hose and attach the hose to the
Figure 2e
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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.
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.
ring blade and twist it in a clockwise motion until it
stops. Do not over tighten.
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3. Attach the pneumatic hose.
Figure 3a
Figure 3b
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.
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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
d. Pass the other end of the pneumatic hose to
Figure 3e
e. Connect the male end of the pneumatic hose
Figure 3d
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engage the connection.
NOTE: Use caution not to drop the hose
prior to assembly.
the circulator. Using a non-perforated
holder, clip or secure the pneumatic hose to
the sterile field , taking care not to compress
the 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
coupler indexed for air.
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style quick connect female
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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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Figure 1
1. Slide the ON/OFF lever on the hand piece to the
Figure 2
2. Press down on the ON/OFF lever to activate the
3. Verify that all connections are secure and that
Figure 4
4. Release the ON/OFF lever, and then slide it to
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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.
ON position.
system. It is now ON.
When the system activates, the disposable
excision ring blade spins.
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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 ex cision ring blade.
the air pressure is set correctly while the system
is running.
NOTE: The required air pressure setting is 100
psi.
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.
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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.).
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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.
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Operating Instructions
This section describes the process for graft harvesting and debridement, and post-operative
procedures.
Graft Harvesting and Debridement
• The Amalgatome SD System is designed for use by qualified and trained medical professionals where the
patient is under supervision of trained personnel.
• Each physician must evaluate the appropriateness of the technique used for each patien t which should be
based on his or her own medical training and expertise.
• Care should be taken in treating individuals with pre-existing conditions that can affect the succes s of the
surgical procedure.
• Every patient is different and results can vary.
• It is recommended to always begin debridement and skin grafting procedures on a low depth setting and
increase the depth gauge as necessary to the optimal setting. The surgical site should be selected per facil ity
protocol for the surgical procedure as determined for skin grafting or wound debridement.
• Skin should be prepared per hospital protocol.
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1. Lubricate the skin graft site with ste ri le m iner a l oi l or ster ile wat er in order to decrease excision ring blade
resistance through the tissue.
NOTE: Prolonged exposure to saline can damage the hand piece or cause pitting or corrosion.
2. Set the depth gauge to the desired setting.
3. Activate the system by sliding the ON/OFF lever to the ON position and pressing down on the lever.
When the system activates, the disposable excision ring blade spins.
4. Position the cutting head at the desired starting point, and then apply a slight downward pressure to ensure the
cutting edge of the disposable excision ring blade maintains contact with the recovery site. Only light pressure
is required.
NOTE: The system cuts with the trailing edge of the excision ring blade.
The excision begins.
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The disposable excision ring
5. Move the cutting head in the desired direction, maintaining a slow and steady speed in order to ensure that the
desired graft thickness and width is recover ed.
NOTE: At any point during the procedure the depth gauge setting can be adjusted by turning the depth
adjustment knob on the gauge either to the left (counterclockwise) to decrease the thickness or to the right
(clockwise) to increase the thi ck ness.
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blade spins in a clockwise
motion. The system cuts with
the trailing edge of the
excision ring blade.
Figure 5
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The excision continues and the skin graft and/or debrided tissue starts to emerge from the cutting head.
6. Use either of the foll owing methods to collect the recovered graft or debrided tissue:
• Method 1: Use tissue forceps to gently lift the graft as it emerges from the cutting head. Do not stretch or
pull the graft as it emerges from the cutting head.
• Method 2: When the graft emerges from the cutting head, allow the graft to collect in the cutting head.
NOTE: There is a 15° angle built into the handle so you do not need to hold the hand piece at an angle to
recover a skin graft or debrided tissue. For additional pictorial reference, refer to th e figur es on the follow ing
page.
Figure 6a
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Cross Section Diagrams
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Figure 6b: Magnified view of cutting head
Direction of motion
Figure 6c: Cutting portion or "trailing edge" of the instrument
held parallel to the patient. Demonstrating good excision ring blade engagement.
Figure 6d: Cutting por tion or "trailing edge" of the instrument
Held at an angle to the patient.
Excision ring blade edge is not in contact.
As you collect the recovered graft, the excision continues.
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7. To end the graft recovery, sever the graft, or stop procedure, move the hand piece in an angled, upward
motion away from patient’s body. This causes the excision ring blade to cut off the end of the graft.
The disposable excision ring blade cuts off the end of the skin graft.
8. Release the ON/OFF lever, and then slide it to the OFF position.
The system deactivates and the disposable excision ring blade stops spinning.
9. For wound debridement, once the surgical site is prepped and determined, begin to debride using techniques
per hospital protocol until the wound bed is properly debrided and ready for the next step in the wound care
protocol.
10. If the device seems to appear “sluggish” or the motor RPM seems to struggle or not perform as normal, it is
acceptable to place a few drops of sterile mineral oil down into the pinion of the hand piece to lubricate the
motor.
11. During the procedure, when the device is not being used and in the OFF position, it is recommended to place
on back table or sterile field location NOT on top of patient or in the operating zone, but in an easy to
accessible sterile location when needed.
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Postoperative Procedure
Perform this procedure after the skin graft has been recovered or the wound debridement procedure is completed
and the Amalgatome SD has been returned to the surgical back table or instrument table. Refer to Appendix D:
Quick Reference Guides for a pictorial reference guide to this procedure.
1. Disconnect the pneumatic hose from the wall source.
2. Use a “push in and twist” motion to unlock it from the security tab, and disconnect the pneumatic hose from
the hand piece.
3. Place the pneumatic hose in the in s trument tray.
4. Remove the disposable excision ring blade from the hand piece. NOTE: Surgical team MUST remove the
excision blade from device and dispose of prior to sending device to SPD for reprocessing.
a. Use the lock ring removal tool to loosen the excision ring blade lock ring by engaging the tool with the
notches in the lock ring and using a counterclockwise motion to remove the ring.
b. Turn the hand piece lever-side-up and allow the excision ring blade to release freely onto the table.
CAUTION: At this time, the excision ring blade is lying gear teeth side down on the table. Do not touch the
inner ring of the excision ring blade. It is the sharp cutting surface. Only handle the blue strip on the outside.
c. Taking care as to not touch the inner ring, grasp the outer ring excision ring blade around the blue strip
and dispose of properly in a designated sharps container per hospital protocol.
d. Place the lock ring and lock ring removal tool back into the sterilization tray.
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5. Disassemble the hand piece from the cutting head.
a. Using a counterclockwise motion, loosen the cutting head from the hand piece.
b. Using sterile water, remove any apparent debris from the Amalgatome SD components in order to prevent
the drying of blood and body fluids.
c. Place the cutting head into the sterilization container.
d. Place the hand piece into the sterilization tray.
CAUTIONS:
• Do not allow blood, tissue, or disinfectants to dry on any part of the Amalgatome SD System.
• Do not use cleaning agents with chlorine or chloride (e.g., saline or bleach ) as the active ingredient as
they are corrosive to stainless steel and can result in physical damage to the system, including rust and
corrosion.
• Do not use saline as it has a corrosive effect on stainless steel and can result in physical damage to the
system.
• Always use cleaning agents that are safe for surgical instruments and stainless steel.
• Immediately disconnect the pneumatic hose once the surgical case is complete.
• Do not lay device on patient when not in use, place on back table or accessible sterile field location.
6. Prepare the Amalgatome SD and sterilization tray for transport to the decontamination department per facility
protocol.
7. Secure the instrument tray for transport.
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Cleaning and Sterilization Instructions
This section describes the Amalgatome SD System cleani ng and sterilization requirements.
The Amalgatome SD is reusable and requires cleaning and sterilization prior to reuse. Manual cleaning and
Automated Cleaning have both been validated for use with the system. It is important to exercise care when
handling the components to protect them from physical damage. Only remove the components as instructed in the
following procedures. Any further disassembly of the system can cause damag e and/or loss of calibration and will
void the warranty. The system contains no user-serviceable parts and must be returned to Exsurco Medical for
repair and maintenance.
As with any decontamination procedure, follow the accepted guidelines for hand washing, use of personal
protective equipment (PPE), etc., as recommended by the Association for the Advancement of Medical
Instrumentation (AAMI) Standards and Recommended practice, Safe Handling and Biological Decontamination
of Medical Devices in Health Care Facilities and in Non-Clinical Settings, current version of ANSI/AAMI ST35.
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CAUTIONS:
• Do not allow blood, tissue, or disinfectants to dry on any part of the Amalgatome SD System.
• Do not use cleaning agents with chlorine or chloride (e.g., saline or bleach) as the active ingredient as they are
corrosive to stainless steel and can resul t in physica l da mage to the system, including rust and corrosion.
• Do not use saline as it has a corrosive effect on stainless steel and can result in physical damage to the system.
• Always use cleaning agents that are safe for surgical instruments and stainless steel.
• Never place the pneumatic hose in any kind of automated washing system.
• Always inspect instruments and devices for rust and corrosion per AORN and hospital protocols.
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Figure 1
2. Disassemble the tray into its individual
Manual Cleaning of the Sterilization Tray
1. Prepare a neutral pH or instrument-safe enzymatic cleaning solution according to the cleaning solution
manufacturer specificat ions .
3. Rinse each component under running tap water for a minimum of one minute in order to remove excess soil.
4. Immerse the base, internal instrument tray, and lid into the cleaning solution and let soak for a minimum of
five minutes. Do not immerse the unit overnight.
5. While still immersed in the cleaning solution, use a non-metal, soft-bristled brush moistened with cleaning
solution to scrub each component for a minimum of two minutes each and until visibly clean.
6. Place each component in a tap water bath for a minimum of one minute, and then repeat one time using fresh
tap water. Do not immerse the unit overnight.
7. Place each component in a critical water (e.g., deionized (DI), reverse osmosis (RO), or distilled water) bath
for a minimum of one minute. Do not immerse the unit overnight.
8. Using a sterile, lint-free wipe, dry each component. Use multiple wipes as necessary.
9. In a well-lit area, visually inspect each component in order to ensure all surfaces are clean and dry.
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components:
• Base
• Lid
• Internal instrument tray
NOTE: For additional part number
information, refer to Appendix B: Parts
Information.
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Automated Cleaning of the S terilization Tray
1. Prepare a neutral pH or instrument-safe enzymatic cleaning solution according to the cleaning solution
manufacturer specificat ions .
2. Disassemble the tray into its individual components:
a. Base
b. Lid
c. Internal instrument tray
NOTE: For additional part number information, refer to Appendix B: Parts Information.
3. Rinse each component under running tap water for a minimum of one minute in order to remov e excess soil .
4. Immerse the base, internal instrument tray, and lid into the cleaning solution and let soak for a minimum of
two minutes. Do not immerse the unit overnight.
5. While still immersed in the cleaning solution, use a non-metal, soft-bristled brush moistened with cleaning
solution to scrub each component for a minimum of one minutes each and until visibly clean.
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Minimum
Tap
Enzymatic Cleaner
Neutral Detergent
Tap
Heated
NA
Place each component in a tap water bath for a minimum of one minute, and then repeat one time using fresh tap
water. Do not immerse the unit overnight.
6. Follow the below automated wash instructions:
Table 1 (Automated Cleaning Instructions for Use- Sterilization Tray)
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Cycle
Prewash 2:00 Cold
Wash 4:00
Neutralize 2:00 Hot Tap
Rinse 0:15 Hot or Heated
Thermal Rinse
Dry 15:00 High (98.8°C)
7. Using a sterile, lint-free wipe, dry each component. Use multiple wipes as necessary.
8. In a well-lit area, visually inspect each component in order to ensure all surfaces are clean and dry.
seconds)
5:00
Temperature
Heated Tap
(60°C)
(90°C)
Type of Detergent/ Water
(per the manufacturer’s instructions)
(per the manufacturer’s instructions)
Heated Deionized or High Purity Water
PN#: X101456, Rev. C Page 25 of 56
AMALGATOME
3. With the exception of the hand piece and
Information.
Figure 3
Figure 4
4. Using a lint-free wipe moistened with the
solution.
Manual Cleaning of the Reusable System
1. Prepare a neutral pH or instrument-safe enzymatic cleaning solution according to the cleaning solution
manufacturer specificat ions .
2. Using the lock nut wrench that is provided with the system, remove the locking knob and locking nut.
NOTE: This is a left-handed thread. Turning the knob and nut clockwise loosens or removes them.
NOTE: These are two separate components so keep them together with other components and take care not to
misplace them.
SD USER GUIDE
Figure 2
®
Immerse
pneumatic hose, immerse the components
into the cleaning solution and let soak for a
minimum of two minutes. Do not immerse
the unit overnight.
Do Not Immerse
NOTE: For additional part number
information, refer to Appendix B: Parts
cleaning solution, wipe the hand piece and
the pneumatic hose for a minimum of one
minute each.
CAUTION: Do not immerse the hand piece
or pneumatic hose into the cleaning
PN#: X101456, Rev. C Page 26 of 56
AMALGATOME
5. Using a non-metal, soft-bristled brush
solution.
Figure 5
6. With the exception of the hand piece and
or pneumatic hose into the water.
Figure 6
7. Moisten a sterile, lint-free wipe with tap
Scrub
Do Not Scrub the
Silicone Hose
SD USER GUIDE
moistened with the cleaning solution, scrub
all of the components with the exception of
the silicone portion of the tubing for a
minimum of 30 seconds each and until
visibly clean.
NOTE: For additional part number
information, refer to Appendix B: Parts
Information.
CAUTION: Do not scrub the silicone
portion of the pneumatic hose. Never place
hose in automated washing system.
CAUTION: Do not immerse the hand piece
or pneumatic hose into the cleaning
®
Immerse
Figure 7
pneumatic hose, place the components into
a fresh tap water bath for a minimum of one
minute, and then repeat one time using fresh
tap water. Do not immerse the unit in water.
In the event the unit is immersed in water
please hold with end where pneumatic hose
attaches to allow for water to drain out.
Do Not Immerse
NOTE: For additional part number
information, refer to Appendix B: Parts
Information.
CAUTION: Do not immerse the hand piece
water, and wipe the hand piece and
pneumatic hose for a minimum of one
minute each. Use multiple wipes as
necessary. Repeat this step one time using
fresh wipes.
CAUTION: Do not immerse the hand piece
or pneumatic hose into the w ate r .
PN#: X101456, Rev. C Page 27 of 56
AMALGATOME
8. With the exception of the hand piece and
DI, RO, or distilled water) bath.
Figure 8
9. Moisten a sterile, lint-free wipe with critical
10. Using a sterile, lint-free wipe, dry each
Figure 10
Place in Critical Water
Do Not Place in Critical
Water
Figure 9
SD USER GUIDE
pneumatic hose, place the components into
a critical water (e.g., DI, RO, or distilled
water) bath for a minimum of one minute.
Do not immerse the unit overnight.
NOTE: For additional part number
information, refer to Appendix B: Parts
Information.
CAUTION: Do not place the hand piece or
pneumatic hose into the critical water (e.g.,
water, and wipe the hand piece and
pneumatic hose for a minimum of one
minute each. Use multiple wipes as
necessary.
CAUTION: Do not immerse the hand piece
or pneumatic hose into the c ri ti ca l (e.g., DI,
RO, or distilled water) water.
®
11. In a well-lit area, visually inspect each component in order to ensure all surfaces are clean and dry.
12. Using the lock nut wrench, replace the locking knob and locking nut back onto the hand piece.
NOTE: This is a left-handed thread. Turning the knob and nut counterclockwise tig h tens or replaces them.
component. Use multiple wipes as
necessary.
Figure 12
PN#: X101456, Rev. C Page 28 of 56
AMALGATOME
It is important when re-assembling the lock nut and locking knob back onto the handpiece the lock nut and
locking knob are placed in the proper order and orientation on the hand piece. Below is a closeup showing the
connection of the lock nut onto the wrench, and the locking knob onto the handpiece for ease in assembly:
Assemble lock nut onto wrench Place lock knob over top of lock nut on wrench, the “U” facing UP.
SD USER GUIDE
®
Slide wrench (with lock nut and lock knob on) over the pinion of handpiece to engage at base of handpiece and
screw on, finger tight, counter clockwise till secure. NOTE: the design on the handpiece should match the lock
knob, and when looking down onto the handpiece the bottom of the U should be facing out.
Automated C leaning of the Reusable System
Please follow the exact same steps outlined above in steps 1-7 for automated cleaning. It is the same pre-cleaning
protocol for the components. When finished with step 7 above, stop (Do Not Follow Steps 8-10). Follow the
automated cycle parameters validated below:
NOTE: Load the Hand piece, open end facing down,
PN#: X101456, Rev. C Page 29 of 56
an angle (to allow for draining) into the washer-disinfector.
AMALGATOME
Time (minutes:
seconds)
Enzymatic Cleaner
instructions)
Neutral Detergent
instructions)
Heated
(90°C)
Heated Deionized or High
Purity Water
Table 1 (Automated Cleaning Instructions for Use- Reusable System)
SD USER GUIDE
®
Cycle
Prewash 2:00 Cold Tap
Wash 4:00
Neutralize 2:00 Hot Tap
Rinse 0:15 Hot or Heated Tap
Thermal Rinse 5:00
Dry 15:00 High (98.8°C) NA
Upon completion of the automated cycle, inspect as outlined below:
9. In a well-lit area, visually inspect each component in order to ensure all surfaces are clean and dry.
10. Using the lock nut wrench, replace the locking knob and locking nut back onto the hand piece.
Minimum Temperature Type of Detergent/ Water
Heated Tap
(60°C)
(per the manufacturer’s
(per the manufacturer’s
Visual Inspect ion
After cleaning and during and after reassembly, visually inspect all system components for visual contaminants. If
any contaminants are present, re-clean following the appropriate cleaning instructions. Perform a component
count in order to ensure that all components are present and none have been lost during the cleaning process.
Check for any corrosion on the laser etching of the components. If present, contact Exsurco Medical Customer
Service for a Service Repair Order at 1-800-243-6049, ext. 4, or email support@exsurco.com.
PN#: X101456, Rev. C Page 30 of 56
AMALGATOME
1. Place the clean components into their proper locations
Figure 1
2. Place each component into the sterilization tray.
Sterilizat ion Preparation
®
SD USER GUIDE
in the previously cleaned s t eri lization tray.
NOTE: There are visual guides, including part
number and description, marking the correct location
for the placement of each component.
Figure 2
3. Double wrap the sterilization tray with all components inside using United States (US) Food & Drug
Administration (FDA)-cleared Center for Scientific Review (CSR)-type wrap per methods listed in current
version of ANSI/AAMI ST79, A1, A2, A3, A4 and adhere with chemical indicator autoclave tape.
• Do not bend or damage any of the components.
• Ensure that the pneumatic hose is coiled carefully
around the outside, taking care as to not crimp it
into the compartment.
• Place the hand piece into the sterilization tray.
• Ensure that the lock nut and lock knob have been
previously assembled to the hand piece.
• Use the lock nut wrench to properly tighten the
knob and nut into place if necessary.
• Do not disassemble the depth gauge.
• Do not disassemble any screws, washers, the
pinion, or the lever from the hand piece.
• Do not remove the end connectors from the
pneumatic hose.
PN#: X101456, Rev. C Page 31 of 56
AMALGATOME
Sterilization
The Amalgatome SD System has only been validated for steam sterilization using the sterilization tray and FDAcleared 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 current version of
AAMI ST8, Hospital Steam Sterilizers.
Utilize one of the two validated steam sterilization methods listed below to provide a sterility assurance level of
-6
10
. Upon completing sterilization, store the Amalgatome SD System in the sterilization packaging in a dry and
dust-free place. The shelf life is dependent on the sterile barrier employed, manner in which product is stored,
environment and handling conditions. A maximum shelf life for sterilized medical devices before use should be
defined by each healthcare facility.
NOTE: See References & Internal Validation details in Appendix E.
SD USER GUIDE
®
Cycle Type Pre-vacuum
Pulses 4
Set-Point Temperature 135°C/ 275°F
Exposure Time 1 3 minutes
Drying Time 2 16 minute in chamber
Cycle Type Gravity
Set-Point Temperature 135°C/ 275°F
Exposure Time 1 10 minutes
Drying Time 2 30 minute in chamber
1
Exposure time: Period for which the load and entire chamber is maintained at the sterilization temperature.
2
Drying time: Period during which steam is removed from the chamber pressure is reduced to permit the evaporation of condensate from the load either by prolonged
evacuation or by the injection and extraction of hot air or other gases. The drying time varies due to load configuration, wrapping method and material. It is the
hospital’s respo nsib il ity to validate the appropriate drying time with the sterilization equipment used.
PN#: X101456, Rev. C Page 32 of 56
AMALGATOME
Problem
Possible Solution
System fails to spin
• Verify that the excis ion ring blade and its mating surfaces are free of lint and other
observed, return the unit to Exsurco Medical for servicing or repair.
SD USER GUIDE
Troubleshooting
This section describes general troubleshooting information, includi ng solutions to potential
problems.
Use the following assessment steps to confirm proper operation of the Amalgatome SD System. If you discover a
problem with any of these items, do not use the system; return it to Exsurco Medical for service. For additional
information, refer to the Warranty, Service, and Returns section.
• Visually inspect the system for any signs of physical damage or wear:
o Loose parts
o Missing or loose screws
o Signs of being dropped or bent
o Areas with corrosion or pitting
• Check for the proper turning of the depth adjustment knob and depth gauge.
• Verify proper connection and fit of the pneumatic hose, ensuring that both ends of the pneumatic hose (to the
hand piece and the air or gas supply) fit properly to their mating receptacles.
• Verify that the air supply is turned on and set to 100 psi and that the wall indicator or pressure gauge is
reading correctly while the system is running.
• If no issues are observed during this assessment but performance issues are experienced, refer to the
troubleshooting table below.
®
excision ring blade
when activated
hand piece when
engaged with the
disposable excision
ring blade and lock
ring installed
PN#: X101456, Rev. C Page 33 of 56
particulate which can hinder free movement of the excision ring blade.
• Check the condition of the excision ring blade lock ring for any distortion or rough
edges that might prevent the excision ring blade from moving properly. In this case,
return the system to Exsurco Medical for service and repair.
• Verify that the on/off button is working properly by sliding the ON/OFF lever to the
ON position, and then pressing down on the lever to engage the motor. If the lever
does not press down on the on/off button, the system will not operate.
• Check the system for any evidence of being dropped or damaged as this can affect the
operation and calibration of the depth gauge. In this case, return the system to Exsurco
Medical for service and repair.
• Check pneumatic air hose for any potential leaks or cuts in it that would prevent the
proper pressure required to power device.
• Remove the excision ring blade, cutting head, and hose from the drive unit. Turn the
pinion (gear) and check for free rotation. Rotation should feel smooth and consistent.
Otherwise it can indicate particulate in the motor or damaged bearings. If this is
AMALGATOME
Problem
Possible Solution
Actual graft
• Note that the actual thickness of the graft is depe nden t upon operator technique, the
to Exsurco Medical for service and repa ir.
Variation in graft
• Note that the actual thickness of the graft is dependent upon operator technique, the
to Exsurco Medical for service and repair.
Graft quality
• Verify that the graft site is lubricated with sterile water or sterile mineral oil to
to Exsurco Medical for service and repair.
SD USER GUIDE
®
thickness varies
from the thickness
guide on the depth
setting
thickness is
observed during
the procedure
pressure applied to the hand piece and onto the sk in, and the location and conditio n of
the tissue being harvested. For more information, refer to the Operating Instructions
section.
• Note that the depth gauge – the mechanism that controls the graft thickness – is set and
calibrated at the factory prior to shipment. Removal of the screws controlling the depth
gauge can affect how the depth gauge performs. If the screws have been removed,
return the system to Exsurco Medical for service and repair.
• Check the system for any evidence of having been dropped or damaged as this can
affect the operation and calibration of the depth gauge. In this case, return the system
pressure applied to the hand piece and onto the skin, and the location and condition of
the tissue being harvested. For more information, refer to the Operating Instructions
section.
• Check all connections and ensure that the system is assembled correctly and the
disposable excision ring blade is eng aged with the pinion to allow free and uniform
movement of the excision ring blade.
• Check the air connection to ensure the pressure setting is 100 psi with the system
running, allowing the motor to provide continuous operation to the excision ring blade
without interruptions in power. An interruption can cause random bursts of power that
might affect the graft thickness.
• Verify that the graft site is lubricated with sterile water or sterile mineral oil in order to
decrease any excision ring blade resistance.
• Check the system for any evidence of having been dropped or damaged as this can
affect the operation and calibration of the depth gauge. In this case, return the system
decrease any excision ring blade resistance.
• Check to make sure there is no debris or defects on the excision ring blade.
• Note that the actual thickness of the graft is dependent upon operator technique, the
pressure applied to the hand piece and onto the skin, and the location and condition of
the tissue being harvested. For more information, refer to the Operating Instructions
section.
• Note that the depth gauge—the mechanism that controls the graft thickness—is set and
calibrated at the factory prior to shipment. Removal of the screws controlling the depth
PN#: X101456, Rev. C Page 34 of 56
gauge can affect how the depth gauge performs. If the screws have been removed,
return the system to Exsurco Medical for service and repair.
• Check the system for any evidence of having been dropped or damaged as this can
affect the operation and calibration of the depth gauge. In this case, return the system
AMALGATOME
Problem
Possible Solution
Disposable excision
• Verify that the excis ion ring blade and its mating surfaces are free of lint and other
system is intended to cut skin only.
Uneven or
• Operate the system with a slow and steady speed. Moving too fast does not allow the
is being used.
Crescent shaped
• Operate the system with a slow and steady speed. Moving too fast does not allow the
is being used.
Skin graft is not
• Note that the depth gauge plate on the hand piece is designed to flatten the skin as it
is being used.
Inadvertently
• The excision ring blade cuts with the trailing edge. Attempting to keep the instrument
is being used.
Gradual loss of
• Re-lubricate the drive unit by placing 1-3 drops of sterile mineral oil in the air inlet,
operating room due to potential for oil misting from the hose exhaust.
SD USER GUIDE
®
ring blade does not
seem to be working
properly
chattered edges on
the skin graft
appearance in the
skin graft
uniform or too
thick/narrow in the
middle
foreign objects which can hinder free movement of the excision ring blade.
• Verify that the excision ring blade is not clogged with debris, skin, or fabric from the
Operating Room (OR) towels, sponges, or drape material, which can hinder free
movement of the excision ring blade.
• Check for any visible nicks or dings in the excision ring blade caused by running over
metal objects. Do not attempt to cut exposed bone, tendon, or simila r m a ter ia l. Th e
user to adjust to body contours or irregularities in tissue.
• Reduce speed and review proper angle and pressure to ensure that the correct technique
user to adjust to body contours or irregularities in tissue. This results in crescent moon
shaped patterns or uneven thickness of grafts.
• Reduce speed and review proper angle and pressure to ensure that the correct technique
approaches the cutting edge.
• Do not apply additional pressure or too much angle on the hand piece because it causes
the tissue to compress itself into the hand piece, resulting in skin grafts that are thick in
the middle and thin on the edges, and too narrow.
• Reduce speed and review proper angle and pres sure to ensure that the correct technique
dissected skin graft
during harvesting
rpm or power
too flat can inadvertently lift the cutting edge away from the recovery site.
• Reduce speed and review proper angle and pressure to ensure that the correct technique
and run the device for 2 minutes to ensure even internal distribution.
**NOTE** it is NOT recommended that this be performed after every use due to the risk
of mineral oil buildup in the hose. It is not recommended that this be performed in the
PN#: X101456, Rev. C Page 35 of 56
Problem
Possible Solution
Instant loss of
• Return the device to Exsurco Medical for service and repair
Lever depression
• Re-lubricate the activation plunger using 1 drop of sterile mineral oil, and exercise the
O-Ring on Hand
• Normal wear of the O-ring is expected. The O-ring will be replaced during the annual
Pneumatic Hose
• Lubricate the O-ring prior to connecting the air hose with sterile mine ral o i l. This w ill
function of the
drive unit (device
no longer capable
of performing an
operation)
AMALGATOME
®
SD USER GUIDE
feels “tacky” or the
lever does not
freely rebound
after release of
pressure
Piece appears worn
difficult to connec t
to hand piece
lever in the ON position until it is no longer “tacky”
Preventive Maintenance.
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 90
Do not use excessive force during the process.
o
angle at the connection site.
PN#: X101456, Rev. C Page 36 of 56
AMALGATOME
SD USER GUIDE
®
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PN#: X101456, Rev. C Page 37 of 56
AMALGATOME
SD USER GUIDE
Warranty, Service, and Returns
This section describes the limited warranty, service requirements, and returns policy.
Limited Warranty
Exsurco Medical (“Exsurco”) warrants that each new Amalgatome SD System and its components have been
tested and inspected, and have left the factory in proper working condition. Exsurco warrants the product is free
from manufacturing defects in material and workmanship under normal use and service for a period of one year
from date of delivery by Exsurco to the customer. The sterile, disposable product is not warranted beyond the
expiration date stated on the product labeling.
• The Amalgatome SD System is guaranteed to be free from defects in material and workmanship when
maintained by the customer, properly cleaned, and used under normal circumstances for its intended purpose.
• Any Amalgatome SD System that is placed by Exsurco under an installment purchase agreement and requires
repair service during the term of such placement agreement shall be repaired in accordance with the terms of
such agreement.
®
During the warranty period, Exsurco shall repair, or at its sole opinion, replace the defective product or part
without cost incurred to the customer. Defective parts replaced under this warranty shall become the property of
Exsurco. This warranty does not cover damage caused by misuse, abuse (dropped or damaged), accident, neglect,
or any use not prescribed in this user guide. If the system becomes defective because of misuse or abnormal
conditions of operations, these repairs shall be charged to the customer. All products returned for warranty or nonwarranty repair must be through the Exsurco return procedure. For more information, refer to the Returns
information below. In no event shall Exsurco be liable for any incidental, indirect, consequential, or punitive
damages in connection with the acquisition or use of Exsurco product. Further, this warranty sha ll not apply to,
and Exsurco shall not be responsible for, any loss or damage arising in connection with the purchase or use of
Exsurco product that has been repaired by anyone other than Exsurco, or altered in any way so as to, in the
judgment of Exsurco Medical, affect the usability or reliability of the product. If this happens, the product repairs
shall be charged to the customer. This limited warranty is exclusive and in lieu or all other warranties, express or
implied, and of all other obligations or liabilities on Exsurco’ s part, and Exsurco neither assumes nor authorizes
any representative or other person to assume for it any other liability in connection with this product.
Exsurco disclaims all other warranties, express or implied, including any implied warranty of merchantability or
of fitness for a particular purpose or application or warranty of quality as well as any express or implied warranty
to patients.
The Exsurco Medical Amalgatome SD System is intended for use only with the Amalgatome SD disposable
excision ring blade. Using another manufacturer’s excision ring blades in conjunction with the Amalgatome SD
voids the product warranty.
PN#: X101456, Rev. C Page 38 of 56
AMALGATOME
Service
The Amalgatome SD System contains no serviceable parts. The system must be returned to Exsurco Medical for
servicing. Exsurco Medical performs all repairs in-house by our trained Technical Serv ice team.
NOTE: Exsurco Medical cannot be held liable for any system malfunctions resulting from repairs or service
performed by anyone other than Exsurco Medical.
Do not attempt to open or disassemble the hand piece. It is a factory-sealed unit with no user serviceable parts
inside. If this happens, it voids the warranty and the customer must return the hand piece to Exsurco Medical for
repair that shall be charged to the customer.
Do not attempt to remove the screws and disassemble the depth gauge on the cutting head for any reason. It has
been factory calibrated to provide optimum cutting performance. If this happens, it voids the warranty and the
customer must return the system to Exsurco Medical for repair that sha ll be charged to the customer. All products
returned for warranty or non-warranty repair must be through the Exsurco Medical return procedure. For more
information, refer to the Returns information below. Exsurco Medical performs all service of the Amalgatome SD
system.
SD USER GUIDE
®
Our Technical Service Department can be contacted at 1-800-243-6049, ext. 5, or email support@exsurco.com
to answer any general questions that relate to the operation, warranty, and service of the system.
The Amalgatome SD System must be returned every 12 months for inspection and preventative maintenance. The
pneumatic hose must be replaced every 12 months or sooner if there is evidence of wear (holes/ cuts/ tea rs). A
review of the hose from Exsurco Medical will determine warranty replacement. Annual factory calibration is
strongly recommended in order to ensure consistent operation and accuracy.
Returns
When it is necessary to return the Amalgatome SD System for inspection and preventative maintenance, warranty
service, or non-warranty service, please contact Customer Service at 1-800-243-6049, ext. 4, or email
support@exsurco.com to receive a Return Material Authorization (RMA) or Service Repair Order (SRO).
Product will not be accepted without an RMA/SRO. Exsurco Medical shall provide the customer with the
approved return shipping container. The customer is responsible for the return freight.
When the customer is returning the system, we require proof of sterilization documents upon receipt of the RMA
or SRO. If proof of sterilization is not included with the system, the system shall be returned for sterilization.
Exsurco Medical does not accept product that has been used without being sterilized first or has not been shipped
with the steriliz a tio n documents. If it is a new product or has not been used, then Customer Service shall note that
on the RMA/SRO documentation.
While the system is at Exsurco Medical for repair, a loaner if available can be requested and shipped to the
customer. Please confirm this with Customer Service at time of the return request.
PN#: X101456, Rev. C Page 39 of 56
AMALGATOME
Upon receiving returned product at Exsurco Medical, the product is reviewed by our Technical Service
Department. Customer Service shall provide the customer with a service estimate for any repairs not covered
under warranty or extended warranty. Exsurco Medical performs all product service on-site in our Technical
Service Department.
When product is ready for shipment back to the customer, Exsurco Medical covers the freight and returns the
product in an approved protective shipping container.
Exsurco Medical stands behind the quality of our products. Should you have a complaint or not be completely
satisfied with your product, please call our Customer Service team to register a complaint. Our Customer Service
team is available Monday through Friday, 8 am to 5 pm ET and is here to assist you in any way. Email
support@exsurco.com or call 1-800-243-6049, ext. 4. To help investigate the event further, we require the
following information:
• Name, address, and account number
• Phone number and email address
• Part/product that the complaint is being filed on
• Serial number (equipment) or lot number (disposable)
• A description of the event:
o Be as descriptive as possible.
o Provide pictures, if available.
• Loaner requirements if available upon request
SD USER GUIDE
®
Once a complaint is received, we may contact you for more information. When the product is returned, a
preliminary evaluation is generally conducted and the product is repaired (if required) and restored to
conformance prior to being shipped back. A closure letter shall be provided advising you of the outcome of the
investigation regarding the reported event.
PN#: X101456, Rev. C Page 40 of 56
AMALGATOME
SD USER GUIDE
®
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PN#: X101456, Rev. C Page 41 of 56
AMALGATOME
Specification
Value
Maximum Graft Width
2-inch Cutting Head: 2 in. (5.08 cm)
4-inch Cutting Head: 4 in. (10.16 cm)
Air Consumption
11 cfm
Input Air Pressure
100 psi, with system running (6.2 bar)
Hospital Grade Air (compressed air, nitrogen)
Storage and Transport
(Amalgatome SD System)
As per internal hospital procedure.
Weight and Measurement
Assembled 2-inch hand piece: 3.1 lb.
Dimensions of the fully assembled tray: 21 x 10.25 x 4 in.
Sterile, Single-Use Excision
Conditions
It is recommended these materials be stored in the provided packaging in a
Humidity Condition Storage Range: 30-70%
SD USER GUIDE
Appendix A: Technical Specifications
Specifications
Assembled 4-inch Unit: 3.7 lb.
Hand Piece and Pneumatic Hose weight: 2.7 lb., length: 15 feet
Complete SDSY S TE M0 24 in s ter il iz a t ion tr ay : 17.8 lb.
Weight of Empty Sterilization Tray: 9.7 lb.
®
ring blades Environmental
cool (under 32°C (90°F)), clean and dry area.
PN#: X101456, Rev. C Page 42 of 56
AMALGATOME
SD USER GUIDE
®
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PN#: X101456, Rev. C Page 43 of 56
AMALGATOME
Quantity
Part #
Description
1 each
X101016
Amalgatome SD Hand Piece (Drive Unit)
1 each
X101005
Amalgatome SD Sterilization Tray
1 each
X101489
Amalgatome SD Sterilization Tray User
1 each
X101004
Amalgatome SD Pneumatic Hose (length:
1 each
X100968
Amalgatome SD 2-inch Cutting Head
1 each
X100969
Amalgatome SD 4-inch Cutting Head
1 each
X100768
Amalgatome SD 2-inch Lock Ring
1 each
X100825
Amalgatome SD 4-inch Lock Ring
1 each
X100966
Amalgatome Lock Ring Removal Tool
1 each
X101133
Amalgatome Lock Nut Wrench
1 each
X101456
Amalgatome SD User Guide
1 each
X101491
Amalgatome SD Intro Letter
SD USER GUIDE
Appendix B: Parts Information
Part #: SDSYSTEM024
Description: Exsurco Amalgatome SD Skin Grafting and Wound Debridement System (2-inch and 4-inch)
Guide
15 ft)
®
Sterile, Disposable Excision ring blades sold separately. Use only the excision ring blades listed below for this
product. Failure to do so voids the warranty and can cause injury:
• Part #: X101006 - 2-inch ASD Excision ring blade (1 each)
• Part #: X101007 - 4-inch ASD Excision ring blade (1 each)
PN#: X101456, Rev. C Page 44 of 56
AMALGATOME
Quantity
Part #
Description
1 each
X101016
Amalgatome SD Hand Piece (Drive
Unit)
1 each
X101005
Amalgatome SD Sterilization Tray
1 each
X101489
Amalgatome SD Sterilization Tray
User Guide
1 each
X101004
Amalgatome SD Pneumatic Hose
1 each
X101968
Amalgatome SD 2-inch Cutting Head
1 each
X100768
Amalgatome SD 2-inch Lock Ring
1 each
X100966
Amalgatome Lock Ring Removal
Tool
1 each
X101133
Amalgatome Lock Nut Wrench
1 each
X101456
Amalgatome SD User Guide
1 each
X101491
Amalgatome SD Intro Letter
Quantity
Part #
Description
1 each
X101016
Amalgatome SD Hand Piece (Drive
Unit)
1 each
X101005
Amalgatome SD Sterilization Tray
1 each
X101489
Amalgatome SD Sterilization Tray
User Guide
1 each
X101004
Amalgatome SD Pneumatic Hose
1 each
X100969
Amalgatome SD 4-inch Cutting Head
1 each
X100825
Amalgatome SD 4-inch Lock Ring
1 each
X100966
Amalgatome Lock Ring Removal
Tool
1 each
X101133
Amalgatome Lock Nut Wrench
1 each
X101456
Amalgatome SD User Guide
1 each
X101491
Amalgatome SD Intro Letter
Exsurco also offers the following Amalgatome SD System configurations in just one size:
Part #: SDSYSTEM02
Description: Exsurco Amalgatome SD Skin Grafting and Wound Debridement System (2- inch)
SD USER GUIDE
®
Part #: SDSYSTEM04
Description: Exsurco Amalgatome SD Skin Grafting and Wound Debridement System (4-inch)
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Ordering Inf orm at i on
To place an order for the Amalgatome SD System, please contact our Customer Service department at 1-800-2436049, ext. 4, or email support@exsurco.com. For a price quote and all product-related questions, please contact
your local Exsurco Medical sales representative or contact our Sales department at 1-800-243-6049, ext. 1, or
email sales@exsurco.com
To order replacement components separately, please contact Customer Service at 1-800-243-6049, ext. 4, or email
support@exsurco.com.
SD USER GUIDE
®
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Symbol
Definition
SD USER GUIDE
Appendix C: Glossary of Sym bol s
®
Serial Number
Batch Code/Lot Number
Manufacturer
Caution: USA federal law restricts this system to sale by or on the order of a
physician.
Use by date. This symbol is intended to indicate that the system should not be used
after the end of the date shown.
Symbol for method of sterilization using radiation.
Symbol indication that the system has not been sterilized.
Do not reuse. Single use, use only once.
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Symbol
Definition
Caution
SD USER GUIDE
®
Consult instructions for use
Keep product dry
Do not use if package is damaged
This side up
Sharp object
General warning sign
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Set depth gauge to
Open package right to left
Teeth side down
Tighten counterclockwise
Sharp excisio n ring blade – do
not touch inner ring
Handle by outside edge
High pressure male
connector
SD USER GUIDE
Appendix D: Quick Reference Guides
Setup
®
preferred setting
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Set depth gauge preferred
setting
Never touch i nner ring of
Postoperative Procedure
SD USER GUIDE
®
excision ri ng blade
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TAP
BATH x2
TAP
WIPE x2
CRITICAL
CRITICAL
WIPE
®
Manual Cleaning of the Reusable System
SD USER GUIDE
SOAK
WIPE
Clean with a soft-bristle brush
WATER
WATER
WATER
BATH
WATER
Lint-free wipe Dry Reassemble lock nut onto hand piece Load ASD into Sterilization Tray
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Supplier
Designation
Comment
Steris
Prolystica® 2X Concentrate
Enzymatic Presoak
neutral pH or instrument safe enzymatic
cleaner
SD USER GUIDE
Appendix E: References for Sterilization
and Details of Validation Report
References
• Current version of ANSI/AAMI/ISO 17665-1 – Sterilization of health care products – Moist heat – Part 1:
Requirements for the development, validation and routine control of sterilization process for medical
devices
• Current version of AAMI TIR12 – Designing, testing and labeling reusable medical devices for
reprocessing in health care facilities: A guide for medical device manufacturers
• Current version of ANSI/AAMI ST81 – Sterilization of medical devices – Information to be provided by
the manufacturer for the processing of resterilizable medical devices
• Current version of ISO 17664 – Sterilization of medical devices – Information to be provided by the
manufacturer for the processing of resterilizable medical devices
• Based on guidelines outlined in AAMI TIR12 – Designing, testing and labeling reusable medical devices
for reprocessing in health care facilities: A guide for medical device manufacturers
• Current version of AAMI TIR30 – A compendium of processes, materials, test methods, and acceptance
criteria for cleaning reusable medical devices
• U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and
Radiological Health, and Office of Device Evaluations (March 17, 2015). Reprocessing Medical Devices
in Health Care Settings: Validation Methods and Labeling - Document Guidance for Industry and Food
and Drug Administration Staff
• Current version of ANSI/AAMI ST8 – Hospital steam sterilizers
• Current version of ANSI/AAMI ST79/A1/A2/ A3/A4 – Comprehensive guide to steam steriliz a tion and
sterility assurance in health care facilities (Consolidated text)
Internal Valid at ion R epor t s
• Steam Sterilization Efficacy Validation of the Amalgatome® SD Reusable Surgical Device Report -
®
Project 154421.
• Cleaning Efficacy Validation of the Amalgatome
Manual Cleaning Report- Project 154421 Part I.
• Cleaning Efficacy Validation of the Amalgatome
Automated Cleaning Validation Summary Report- 165647
• The cleaning agents listed below were used by Exsurco Medical when validating the instructions for
processing provided in this document.
• Exsurco Medical does not recommend these products in preference to others that are available. Other
products may perform equally in conjunction with the equipment being used. The instructions provided
by the supplier of the detergents should be followed. Personal protection for operators should be
provided in accordance with the supplier´s instructions and safety data sheets. Suitability of alternative
agents should be checked by reference to the supplier’s information and/or physical testing.
®
SD Reusable Surgical Device and Sterilization Tray –
®
SD Reusable Surgical Device and Sterilization Tray –
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SD USER GUIDE
Help Information
Contact Information
Please refer to the information below for contacting Exsurco Medical directly for any of your questions,
comments, or concerns about the Amalgatome SD.
Phone: 1-800-243-6049
Website: www.exsurco.com
Press the number below for the following
departments or email at:
1 – Sales & Clinical Support:
sales@exsurco.com
2 – Marketing & Product Inquiries:
information@exsurco.com
4 – Customer Service or to Report a Quality
Concern: support@exsurco.com.
5 – System or Technical Service:
support@exsurco.com
6 – Quality Department: support@exsurco.com
7 – Accounting Department:
support@exsurco.com
®
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Exsurco Medical
10804 Green Road
Wakeman, OH 44889
Exsurco Medical
P.O. Box 376
Vermillion, OH 44089
© 2017 Exsurco Medical, Inc. All Rights Reserved
Amalgatome® and Exsurco® are registered trademarks of Exsurco Medical, Inc.
PN: X101456, Rev. C
Date Issued: January 31, 2018
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