ADVANTAGE PLUS Pass-Thru User Manual Rev D 2016

MEDIVATORS®, ADVANTAGE®, ENDORA®, INTERCEPT® and RAPICIDE® are registered trademarks of Medivators Inc. OLYMPUS® is a registered trademark of Olympus Corporation. WINDOWS® is a registered trademark of MICROSOFT Corporation.

50098-704 REV D, ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor © 2016 Medivators Inc. All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or the use of this publication is prohibited without the express written consent of Medivators Inc. Medivators reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your Medivators representative or Medivators customer service for more information. 2

TABLE OF CONTENTS CHAPTER 1 Introduction Using this manual ... 6 ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor Features ... 6 Safety ... 7 Regulatory Compliance ... 8 Notes, Cautions and Warnings ... 8 Operator Safety ... 9 Installation and Maintenance ... 11 Guidelines for Reliable Disinfection... 12 Professional Guidelines ... 14 Warning Summary ... 16 Reprocessor Label Symbols ... 18 CHAPTER 2 System Overview Main Components ... 20 ADVANTAGE Software ... 29 Clean Side Display Scheme ... 35 CHAPTER 3 Operation System Startup ... 40 Prepare the Endoscope... 40 Disinfection Process Summary ... 47 Starting a Disinfectant Cycle ... 48 Disinfection Cycle Interruptions ... 50 Cycle Completion of a Successful Cycle: Clean Side ... 50 Cycle Completion of a Successful Cycle: Dirty Side ... 51 Cycle Completion of a Failed Cycle ... 52 Delayed Start ... 52 Testing Disinfectant MRC ... 53 Reports ... 55 CHAPTER 4 Chemistry and Utilities Chemistry ... 60 Replacing Disinfectant ... 61 Replacing Detergent ... 64 Replacing Alcohol ... 65 Water Line Disinfection ... 67 Wash Test Utility... 71 Final Rinse Water Sample Utility ... 71 Take Water Sample Utility ... 72 CHAPTER 5 Maintenance Weekly Maintenance... 74 Monthly Maintenance ... 77 6 Month Maintenance ... 79 Replacing the 0.4 micron Water Filter ... 82 Replacing the 0.2 micron Water Filter... 86 Computer Shut Down ... 90 3

Emergency Power Down ... 90 Complete Reprocessor Shut Down ... 90 Emergency Door Opening ... 91 CHAPTER 6 Troubleshooting Introduction ... 94 Error Overview... 97 System Errors ... 102 Barcode Errors ... 106 Endoscope Errors ... 107 Reprocessing Cycle Errors ... 112 Control Errors (SCU) ... 120 Warning Errors ... 125 CHAPTER 7 System Administration ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor Software 132 Management Program ... 134 Endoscope Entry ... 132 Dual Endoscope Entry ... 136 User Entry ... 143 Physician/Assistants Entry ... 145 Reports ... 147 LIO Expert Mode ... 154 Backups...155 Networking ... 155 APPENDIX A Reprocessor Specifications ... 158 APPENDIX B Replacement Part Numbers ... 166 APPENDIX C Warranty ... 168

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CHAPTER 1 INTRODUCTION This chapter describes the MEDIVATORS® ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor.

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Using This Manual This manual describes the features of the ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor, including the hardware, software, setup, operation, safety, maintenance, and troubleshooting procedures. It is important to follow the instructions provided to keep the ADVANTAGE PLUS Pass-Thru Reprocessor in proper operating order and to ensure that endoscopes receive adequate disinfection. This is not a service manual and does not provide detailed instructions for service beyond general maintenance. See the Service Manual for servicing instructions. Contact your service representative for additional service information.

ADVANTAGE PLUS Pass-Thru Reprocessor Features The ADVANTAGE PLUS Pass-Thru Reprocessor was designed for ease of use and maintenance in the disinfection of endoscopes. Features include:  Pass thru design.  Individual channel flow, connectivity and blockage monitoring.  Automated endoscope leak test  Single use disinfectant: fresh disinfectant solution for each endoscope.  Asynchronous operation of dual reprocessing basins with transparent glass doors.  A dedicated computer for system operation of reprocessing cycle, cycle recording, powerful quality assurance reporting, easy backups, networking availability, and remote diagnostics  Computer protected by built in UPS.  Hookup blocks and parameter sets dedicated to a family of endoscopes ensure correct channel monitoring, pressures and flow rates to meet manufacturers’ specifications. • Automated alcohol flush. • Automated detergent flush.

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Intended Use The ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor is intended for the high level disinfection of endoscopes and endoscope accessories. The ADVANTAGE PLUS Pass-Thru Reprocessor has been validated by Medivator for use only with RAPICIDE® PA High-Level Disinfectants and INTERCEPT® PLUS Detergent. Indications for Use of the ADVANTAGE PLUS® Pass-Thru Reprocessor: The ADVANTAGE PLUS Pass-Thru Endoscope Reprocessing System tests, washes, disinfects and rinses endoscopes, such as fiber optic and video endoscopes between patient uses. The ADVANTAGE PLUS Pass-Thru Reprocessor is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. The ADVANTAGE PLUS Pass-Thru Endoscope Reprocessing System uses RAPICIDE PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses INTERCEPT PLUS Detergent in its wash cycle. RAPICIDE PA Test Strips are used at the end of each disinfection cycle to ensure that the used disinfectant is at or above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. RAPICIDE PA should be used in the ADVANTAGE PLUS Pass-Thru Reprocessor under the following contact conditions: Contact Time: Temperature: MRC: `

5 minutes 20°C 850 ppm

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Regulatory Compliance The ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor complies with ISO 15883-1 and 15883-4. The ADVANTAGE PLUS Pass-Thru Reprocessor complies with IEC 61326 Electromagnetic Compatibility (EMC) Standards. The reprocessor is ETL and cETL certified and listed for safety per IEC Standard IEC 61010-1 and IEC 61010-2-40, UL, Standard UL 61010-1 and Canadian Standard CAN/CSA-C22.2 No. 61010-1 for laboratory equipment.

Notes, Cautions, and Warnings Throughout the manual are notes, service notes, cautions, and warnings. These provide important information and you should pay special attention to them. Examples are shown below.

Note: A note refers to important information to which you should pay special attention.

Service: A service note refers to operations or repairs that only a trained service technician may perform.

Caution A caution describes actions or conditions that may cause damage to or destruction of the equipment.

WARNING A warning describes actions and conditions that may cause severe personal injury or death to the operator or patient.

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Operator Safety 

Equipment must be operated solely by qualified personnel, and used for its intended use only. Never use the reprocessor for any purpose other than the manufacturer’s specific intended purpose. WARNING To avoid biological contamination and chemical burns; always wear appropriate personal protective equipment (PPE) when handling endoscopes or disinfectant solutions.

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Washing and disinfectant solutions must be used according to the regulations governing their use, safety, and shelf life. Do not attempt to open the reprocessor door during operation. For peracetic acid (PAA) disinfectant handling guidelines contact the disinfectant manufacturer. In case of eye contact, skin contact or inhalation, please refer to the detergent and disinfectant manufacturer's guidelines for first aid. In the event of a disinfectant or other chemical leak, use personal protective equipment (clothing, glove & safety glasses) & follow the disinfectant manufacturer’s guidelines for spill clean-up procedures. Place guidelines for disinfectant clean-up in an easily visible area near the reprocessor to ensure users will have access to the information when needed. It is recommended that the facility conduct regular training of all personnel concerned with the operation and maintenance of this equipment, including emergency procedures for toxic, flammable or pathogenic material released into the environment. Records of attendance at training should be maintained and evidence of understanding demonstrated.

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Handling and storage of 70% Isopropyl Alcohol. 

Handling Avoid prolonged or repeated contact with skin. Extinguish any naked flames. Remove ignition sources. Avoid sparks. Do not smoke. Take precautionary measures against static discharges. Earth all equipment. Do not empty into drains.

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Handling Temperatures Ambient.

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Storage Keep away from direct sunlight and other sources of heat or ignition. Do not smoke in storage areas. Keep container tightly closed and in a well-ventilated place.

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Storage Temperatures Ambient.

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Product Transfer Take precautionary measures against static discharges. Earth all equipment. Avoid splash filling.

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Respiratory Protection No specific measures

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Eye Protection Goggles or face shield.

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Body Protection Standard issue work clothes. Safety shoes or boots, chemical resistant.

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Installation and Maintenance Proper maintenance ensures effective disinfection and prolongs the life of the reprocessor.  ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor must be grounded in accordance with applicable regulations.  The reprocessor should not be placed on surfaces which could cause a fire or fume hazard.  The system default is factory-set for the specific disinfectant immersion time for RAPICIDE® PA High-Level Disinfectants.  All pressure regulators are factory-preset. Do not adjust the settings. Contact your Technical Support representative for assistance.  MEDIVATOR endoscope hookups are not autoclavable. The hookups are automatically disinfected with each use due to their exposure to the entire disinfection cycle; no further disinfection or rinsing is required prior to their next use.  Do not remove covers, doors, or panels fastened with screws while the reprocessor is in use.  Replacement parts must be ordered from the manufacturer to maintain the warranty.  Do not block ventilation openings.  Regularly check all cables, tubing, and drains for damage or leaks.  Do not carry out any maintenance that is not described in this manual.  Ensure that the power connection is accessible in the event that emergency disconnection is necessary.  Prior to undertaking any service or maintenance operations or when resetting the RCD or GFI, ensure that the ADVANTAGE PLUS Pass-Thru Reprocessor is disconnected from the main power supply.  If service or maintenance operations are to be conducted on the water system, ensure that the ADVANTAGE PLUS Pass-Thru Reprocessor is isolated from the main water supply.  Yearly preventive maintenance required, contact Medivators for details. For service or service-related questions, contact Medivators Technical Support or your local Medivators Distributor.

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Guidelines for Reliable Disinfection Water Quality Potable water is the minimum standard. Medivators recommends the use of a high quality water pre filtration system that filters incoming water to 1 micron. 

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The high performance 0.2 micron (absolute rated) water filters included with the reprocessor are highly effective at removing microorganisms and particles larger than 0.2 microns. Appropriate pre-filtration and regular disinfection are required to maintain the performance of this filter. The routine maintenance schedule recommends replacing the 0.2 micron water filter every six months or sooner, depending on the pre-filtration system and the quality of the incoming water. If the filter clogs to the point of non-effectiveness, the reprocessor will alarm and will not continue until the filter is replaced. To meet the ISO 15883-4 water quality standards the water line disinfection must be performed weekly.

Disinfectant Solution Use only with RAPICIDE® PA High Level Disinfectant (Part A & Part B). Detergent Solution INTERCEPT® PLUS Detergent must be used in the washing phase of the reprocessing cycle. INTERCEPT PLUS Detergent is formulated to use with medical instruments. Monitoring Disinfectant Potency The efficacy of a disinfection procedure is directly related to the disinfectant solution used, and the amount of time the endoscope is exposed to that solution.   

RAPICIDE PA High-Level Disinfectants must be monitored for potency every reprocessing cycle according to the instructions in this manual. Use the RAPICIDE PA Test Strips to test the potency of the solution. If the potency of the solution is below MRC minimum recommended concentration (MRC), discard and replace it with fresh solution. Never use disinfectant with unacceptable potency levels.

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Endoscope Washing and Leak Testing The ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor may be used with all makes and sizes of flexible, immersible endoscopes that can be internally and externally disinfected. Proper endoscope disinfection is required because endoscopes have multiple internal channels that have the potential to harbor microorganisms that could cross-contaminate patients. Reprocessing quality depends largely on a thorough pre-cleaning of all endoscope channels, valves and fittings where contamination can occur. This reprocessor includes a washing cycle. Soiled endoscopes must be pre-cleaned according to manufacturer’s guidelines and your internal facility procedures before reprocessing. Follow the endoscope manufacturer’s instructions and established professional guidelines while precleaning and disinfecting endoscopes. Leak test all endoscopes prior to placement in the ADVANTAGE PLUS Pass-Thru Automated Endoscope Reprocessor.

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Professional Guidelines The following organizations have published recommended guidelines for cleaning and disinfecting endoscopes.

Society of Gastroenterology Nurses and Associates 330 N. Wabash Ave., Suite 2000 Chicago, IL 60611-7621 USA Tel: 800-245-7462 www.sgna.org

American Society for Gastrointestinal Endoscopy 3300 Woodcreek Dr. Downers Grove, IL 60515 USA Tel: 866-353-2743 www.asge.org

British Society of Gastroenterology 3 St Andrews Place, Regent's Park, London NW1 4LB ENGLAND Tel: (+44) (0)20 7935 3150 www.bsg.org.uk

Association for Professionals in Infection Control and Epidemiology 1275 K St, NW, Suite 1000 Washington, DC 20005 USA Tel: 1-800-650-9570 www.apic.org

Canadian Society of Gastroenterology Nurses and Associates #224, 1540 Cornwall Road Oakville, ON L6J 7W5 CANADA www.csgna.com

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Warning Summary WARNING Portable and mobile communication devices can affect electrically-operated medical equipment WARNING Connecting a chemical container with the incorrect fluid may cause the endoscope to be improperly disinfected. Do not use the endoscope on a patient if this occurs. WARNING Wear personal protective equipment (PPE) (clothing, mask, gloves & eye wear). WARNING All endoscope hookups must be periodically inspected for wear. Discard and replace damaged hookups otherwise it could result in an endoscope that is not disinfected and therefore should not be used on a patient. WARNING Verify all connections to the endoscope are secure and tubing is not linked. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient. WARNING Verify the connection tubing does not interfere with the spray head and confirm that the spray function is working during the cycle. Failure to do this could result in an endoscope that is not disinfected and therefore should not be used on a patient. WARNING Before removing the endoscope, verify all connections to the endoscope are secure. If an adapter is loose or disconnected, the disinfection was not complete and must be repeated. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient. WARNING Report all system errors to your supervisor. WARNING Wear clean gloves to prevent soiling of the disinfected endoscope. WARNING If a run error was generated, a channel is blocked, or the endoscope is leaking, the endoscope must not be released for patient use. If there is any doubt as to whether an endoscope is correctly disinfected, it must be disinfected again before use. Contact your supervisor for further instructions. WARNING Verify all endoscope connections are secure. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient. WARNING Avoid possible chemical burns. Wear personal protective equipment (clothing, mask, gloves & eye wear). WARNING Use only disinfectant and detergent approved by Medivators Inc. WARNING Check the expiration date of the disinfectant in the reprocessor each day. 16

WARNING Never use disinfectant beyond the manufacturer’s expiration date, even if the MRC level is acceptable. WARNING Never use disinfectant that tests below the acceptable MRC level, even if it has not yet reached the expiration date. WARNING If the MRC test fails the endoscope has not been disinfectant and should not be used on a patient. WARNING When replacing disinfectant, wear personal protective equipment (clothing, mask, gloves & eye wear). The disinfectant and detergent manufacturers may recommend additional protection. WARNING If leaking liquid is present and you suspect it is disinfectant read and follow the disinfectant instructions before attempting a cleanup. WARNING Never use the equipment in a manner inconsistent with the manufacturer’s guidelines. Using the equipment in a manner inconsistent with the manufacturer’s guidelines may impair the protections that are designed into the device and may cause injury to the user. WARNING The basin doors are made of tempered glass. In the unlikely event of breakage, please do not use the endoscope in the basin and contact Medivators Technical Service. WARNING In the event of both the dirty and clean doors being open on a single basin, remove the endoscope from the dirty side and reprocess again before use. Please contact Medivators Technical Service.

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Reprocessor Label Symbols Below are descriptions of the various symbols used throughout the ADVANTAGE PLUS® PassThru Automated Endoscope Reprocessor.

Wear proper PPE

Acid Present

High Voltage Present

Use Caution

Refer to the User Manual

Date of Manufacture

Alternating Current

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CHAPTER 2 SYSTEM OVERVIEW This chapter is an overview of the ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor.

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Main Components Exterior Components The ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor consists of two independent reprocessing modules. Each has a basin, automatic dirty and clean side doors, and the necessary pumps and valves t o wash, disinfect, rinse, and dry most models of flexible, submersible endoscopes.

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Figure 1 Dirty Side Front View

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1. Touchscreen Monitor: Displays the reprocessor software, the touchscreen is used to control the software. 2. Barcode Scanner: Wireless barcode scanner used for entering operator, endoscope, hookup, chemistry lot number, doctor and patient ID information. 3. Chemical Drawer: Pullout drawer houses the disinfectant and detergent. 4. Access Doors: Doors open to allow access to the water filters, alcohol container and the sample ports. 5. Foot Switch: Allow hands free door opening and closing. 6. Overhead Compartment: Contains the computer, UPS, circuit breaker, facility connection (air, water, electrical, network, and ventilation). This compartment is only accessible from the dirty side. 7. Overhead Control Panel: Contains the main power switch and the computer power switch. 8. Windows with Intercom: Gives the ability to see as well as communicate with the clean side operators. 9. Basin Doors: The basin doors move up and down to give access to and enclose the basins. 10. Control Panel: Allows for the control of the reprocessor and its software.

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