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Exsurco Medical Amalgatome SD User Manual

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

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  • Page 1 ® Amalgatome User Guide EXSURCO MEDICAL 10804 GREEN ROAD WAKEMAN, OH 44889 PN: X101456 REV. C...
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  • Page 3 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.
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  • Page 5: Table Of Contents

    ® SD U MALGATOME UIDE 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 ..............................
  • Page 6 ® SD U MALGATOME UIDE 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............................

  • Page 7: Preface

    UIDE 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.
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  • Page 9: System Overview

    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.

  • Page 10: Components

    ® SD U MALGATOME UIDE 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.

  • Page 11: How Supplied

    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.

  • Page 12: Contraindications

    ® SD U MALGATOME UIDE 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 •...

  • Page 13: General Warnings And Precautions

    • 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.
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  • Page 15: Setup Instructions

    UIDE 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.
  • Page 16 ® SD U MALGATOME UIDE c. Hand-tighten the locking knob clockwise until it stops; do not over tighten. Figure 1c d. Adjust the depth gauge to the preferred operating setting. Figure 1d 2. Open and install the disposable excision ring blade. a.
  • Page 17 ® SD U MALGATOME UIDE 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.
  • Page 18 ® SD U MALGATOME UIDE sterile mineral oil on the O-ring to help engage the connection. NOTE: Use caution not to drop the hose prior to assembly. 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.

  • Page 19: System Check

    ® SD U MALGATOME UIDE 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. 1. Slide the ON/OFF lever on the hand piece to the ON position.

  • Page 20: Depth Gauge Setting

    ® SD U MALGATOME UIDE 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.

  • Page 21: Operating Instructions

    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 patient which should be based on his or her own medical training and expertise.
  • Page 22 ® SD U MALGATOME UIDE 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 recovered. 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 thickness.
  • Page 23 ® SD U MALGATOME UIDE Cross Section Diagrams 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 portion or "trailing edge" of the instrument Held at an angle to the patient.

  • Page 24: 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.
  • Page 25 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.
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  • Page 27: Cleaning And Sterilization Instructions

    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.

  • Page 28: Manual Cleaning Of The Sterilization Tray

    ® SD U MALGATOME UIDE Manual Cleaning of the Sterilization Tray 1. Prepare a neutral pH or instrument-safe enzymatic cleaning solution according to the cleaning solution manufacturer specifications. 2. Disassemble the tray into its individual components: • Base • • Internal instrument tray NOTE: For additional part number information, refer to Appendix B: Parts...
  • Page 29 ® SD U MALGATOME UIDE 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) •...

  • Page 30: Manual Cleaning Of The Reusable System

    ® SD U MALGATOME UIDE Manual Cleaning of the Reusable System 1. Prepare a neutral pH or instrument-safe enzymatic cleaning solution according to the cleaning solution manufacturer specifications. 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.
  • Page 31 ® SD U MALGATOME UIDE 5. Using a non-metal, soft-bristled brush 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.
  • Page 32 ® SD U MALGATOME UIDE 8. With the exception of the hand piece and 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.

  • Page 33: Automated Cleaning Of The Reusable System

    ® SD U MALGATOME UIDE 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”...

  • Page 34: Visual Inspection

    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.

  • Page 35: Sterilization Preparation

    ® SD U MALGATOME UIDE Sterilization Preparation 1. Place the clean components into their proper locations in the previously cleaned sterilization tray. NOTE: There are visual guides, including part number and description, marking the correct location for the placement of each component. Figure 1 2.

  • Page 36: Sterilization

    UIDE Sterilization The Amalgatome SD System has only been validated for steam sterilization using the sterilization tray and FDA- cleared wrap. Should any other method or sterilization tray be used, it is the sole responsibility of the facility to validate any sterilization parameters that are not provided directly by the manufacturer. The Amalgatome SD System is provided non-sterile and must be sterilized prior to use.

  • Page 37: Troubleshooting

    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.
  • Page 38 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.
  • Page 39 ® SD U MALGATOME UIDE Problem Possible Solution • Disposable excision Verify that the excision ring blade and its mating surfaces are free of lint and other ring blade does not foreign objects which can hinder free movement of the excision ring blade. •...
  • Page 40 ® SD U MALGATOME UIDE Problem Possible Solution • Instant loss of Return the device to Exsurco Medical for service and repair function of the drive unit (device no longer capable of performing an operation) • Lever depression Re-lubricate the activation plunger using 1 drop of sterile mineral oil, and exercise the feels “tacky”...
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  • Page 42: Warranty, Service, And Returns

    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’...

  • Page 43: Service

    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.
  • Page 44 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.
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  • Page 46: Appendix A: Technical Specifications

    100 psi, with system running (6.2 bar) Hospital Grade Air (compressed air, nitrogen) Storage and Transport As per internal hospital procedure. (Amalgatome SD System) Weight and Measurement Assembled 2-inch hand piece: 3.1 lb. Assembled 4-inch Unit: 3.7 lb. Hand Piece and Pneumatic Hose weight: 2.7 lb., length: 15 feet Complete SDSYSTEM024 in sterilization tray: 17.8 lb.
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  • Page 48: Appendix B: Parts Information

    ® SD U MALGATOME UIDE Appendix B: Parts Information Part #: SDSYSTEM024 Description: Exsurco Amalgatome SD Skin Grafting and Wound Debridement System (2-inch and 4-inch) Quantity Part # Description 1 each X101016 Amalgatome SD Hand Piece (Drive Unit) 1 each...
  • Page 49 ® SD U MALGATOME UIDE 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) Quantity Part # Description 1 each X101016...

  • Page 50: Ordering Information

    UIDE Ordering Information To place an order for the Amalgatome SD System, please contact our Customer Service department at 1-800-243- 6049, 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...
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  • Page 52: Appendix C: Glossary Of Symbols

    ® SD U MALGATOME UIDE Appendix C: Glossary of Symbols Symbol Definition 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.
  • Page 53 ® SD U MALGATOME UIDE Symbol Definition Caution Consult instructions for use Keep product dry Do not use if package is damaged This side up Sharp object General warning sign PN#: X101456, Rev. C Page 49 of 56...

  • Page 54: Appendix D: Quick Reference Guides

    ® SD U MALGATOME UIDE Appendix D: Quick Reference Guides Setup Open package right to left Teeth side down Set depth gauge to Handle by outside edge Tighten counterclockwise preferred setting Sharp excision ring blade – do not touch inner ring High pressure male connector PN#: X101456, Rev.

  • Page 55: Postoperative Procedure

    ® SD U MALGATOME UIDE Postoperative Procedure Set depth gauge preferred setting Never touch inner ring of excision ring blade PN#: X101456, Rev. C Page 51 of 56...

  • Page 56: Manual Cleaning Of The Reusable System

    ® SD U MALGATOME UIDE Manual Cleaning of the Reusable System WIPE SOAK Clean with a soft-bristle brush WATER WATER BATH x2 WIPE x2 CRITICAL CRITICAL WATER WATER BATH WIPE Lint-free wipe Reassemble lock nut onto hand piece Load ASD into Sterilization Tray PN#: X101456, Rev.
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  • Page 58: Appendix E: External References For Sterilization And Details Of Validation Report

    Cleaning Efficacy Validation of the Amalgatome SD Reusable Surgical Device and Sterilization Tray – 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. Supplier Designation Comment ®...
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  • Page 60: Help Information

    MALGATOME UIDE 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 –...
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  • Page 62 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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