ADVANTAGE PLUS 2.0 User Manual

CLEVO™ is a trademark of Clevo Corporation EPSON® is a registered trademark of Seiko Epson Kabushiki Kaisha FUJIFILM™ is a trademark of Fujifilm Corporation HEPA® is a registered trademark of HEPA Corporation JUN-AIR® is a registered trademark of Gast Manufacturing, Inc. MEDIVATORS® is a registered trademark of Medivators Inc. ADVANTAGE PLUS® and RAPICIDE® are registered trademarks of Medivators Inc. OLYMPUS® is a registered trademark of Olympus Corporation. PENTAX® is a registered trademark of Hoya Corporation. WINDOWS® and WINDOWS EXPLORER® are registered trademarks of Microsoft Corporation. XION® is a registered trademark of XION Medical GmbH. 50098-1025-EN REV A– ADVANTAGE PLUS 2.0 © 2015 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.

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TABLE OF CONTENTS CHAPTER 1 Using this manual...5 Safety...6 Operator Safety...7 Installation and Maintenance...9 Guidelines for Reliable Disinfection...10 Professional Guidelines...12 Reprocessor Specifications...13 Dimensions and Clearances...14 Installation Specifications...15 Storage...16 Transport...16 Symbols and Icons...17 Warning Summary...18 CHAPTER 2 Main Components...22 Software System...33 Printing ... 41 Backup ... 43 Fluid System...44 CHAPTER 3 System Startup...54 Daily Service...54 Prepare the Endoscope...62 Disinfection Process Summary...68 Run the Disinfection Program...69 Cycle Interruptions...74 Taking a Sample of Disinfectant – Check MRC...77 Complete the Disinfection Process...79 Reports...81 Shutdown...85 Procedure Summary...86 Downtime...86 CHAPTER 4 Daily Maintenance...88 Weekly Maintenance...88 Monthly Maintenance...89 Air Filter Replacement...89 Water Filter Replacement...92 CHAPTER 5 Introduction...100 Error Overview...104 System Errors...109 Barcode Errors...113 Endoscope Errors...114 ADVANTAGE PLUS User Manual

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Reprocessing Cycle Errors...119 Control Errors (SCU)...126 Warning Errors...130 CHAPTER 6 MEDIVATORS® ADVANTAGE PLUS® System Software...138 Management Program...140 Endoscope Registration...145 User (operator) Registration...150 Physician/Assistant Registration...153 Reports...155 Events...159 Systems...161 LIO Expert Operations...163 Networking...167 APPENDIX A...171 Registration Forms APPENDIX B...179 Replacement Part Numbers APPENDIX C...181 Warranty

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CHAPTER 1

INTRODUCTION

This chapter describes the MEDIVATORS® ADVANTAGE PLUS® System endoscope reprocessor.

Using This Manual This manual describes the features of the MEDIVATORS ADVANTAGE PLUS endoscope reprocessor, including the hardware, software, setup, operation, safety, maintenance, and troubleshooting procedures. It is important to follow the instructions provided to keep the MEDIVATORS ADVANTAGE PLUS System 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 Service Manual for servicing instructions. Contact your service representative for additional service information.

MEDIVATORS ADVANTAGE PLUS Features The MEDIVATORS ADVANTAGE PLUS System was designed for ease of use and maintenance in the disinfection of endoscopes. Features include: • Individual channel connectivity and channel blockage monitoring. • Single use germicide: fresh disinfectant solution for each endoscope. • Asynchronous operation of dual reprocessing basins with transparent glass lids. • A dedicated personal computer (PC) for system operation of reprocessing cycle, cycle recording, powerful quality assurance reporting, easy backups, networking availability, and remote diagnostics • Easy-to-fill detergent and alcohol reservoirs • Hookup blocks dedicated to a family of endoscopes ensure correct connectivity and flow rates to meet manufacturers’ specifications • Diagnostics for operator assistance and troubleshooting • Optional cleaning cycle as an equivalent alternative to certain manual cleaning steps that can be used to enhance the overall cleaning process of endoscopes prior to high-level disinfection. Endoscopes must be meticulously pre-cleaned immediately after use. ADVANTAGE PLUS User Manual

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Safety Intended Use The MEDIVATORS® ADVANTAGE PLUS® System is intended for the cleaning and high level disinfection of endoscopes and endoscope accessories. The MEDIVATORS ADVANTAGE PLUS System has been validated by MEDIVATORS for use only with RAPICIDE® PA High-Level Disinfectant or MATRIX® Detergent. MEDIVATORS ADVANTAGE PLUS Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The ADVANTAGE PLUS system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes must be conducted in accordance with endoscope manufacturer’s instructions, professional guidelines and facility protocols. Endoscopes must be meticulously pre-cleaned immediately after use. The ADVANTAGE PLUS 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 MATRIX Detergent in its cleaning cycle at a concentration of 0.5%. RAPICIDE PA Test Strips are used after the 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 System under the following contact conditions*: Contact Time:

5 minutes

Temperature:

30°C

MRC: 850 ppm Use-conditions may vary by country. Please contact your MEDIVATORS representative for information. CAUTION: Although the ADVANTAGE PLUS reprocessor contains an optional cleaning cycle as an equivalent alternative to certain manual cleaning steps, endoscopes must be meticulously precleaned immediately after use and then manually cleaned according to the endoscope manufacturer’s instructions, professional guidelines and facility protocols. The optional cleaning cycle should be used as an enhancement to the overall cleaning process.

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Regulatory Compliance The MEDIVATORS® ADVANTAGE PLUS® System complies with EN 60601-1-2 Electromagnetic Compatibility (EMC) Standards. The reprocessor is ETL and cETL certified and listed for safety per IEC Standard IEC 61010-1, 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.

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.

• • •

Cleaning and disinfectant solutions must be used according to the regulations governing their use, safety, and shelf life. Do not attempt to open the reprocessor lid during operation. Do not place heavy objects on the glass covers.

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•

For peracetic acid (PAA) disinfectant handling guidelines, refer to Module 3 Workplace Health and Safety of the GENCA guidelines as available on the QLD health website at URL:https://www.health. gld.gov.au/EndoscopeReprocessing/module_3/3_5b.asp. • In the event of a disinfectant or other chemical leak, use personal protective equipment (clothing, gloves & 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. 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. Handling Temperatures Ambient. 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. Storage Temperatures Ambient. Product Transfer Take precautionary measures against static discharges. Earth all equipment. Avoid splash filling. Respiratory Protection No specific measures. Eye Protection Monogoggles. 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. • The MEDIVATORS® ADVANTAGE PLUS® System must be grounded in accordance with applicable regulations. • The system default is factory-set for the specific disinfectant immersion time for RAPICIDE® PA. • All pressure regulators are factory-preset. Do not adjust the settings. Contact your Technical Support representative for assistance. • Do not allow the washing solution to contact metal components. • Do not use alcohol or alcohol-based products to clean the reprocessor cabinet. • Medivators 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 supply connection is accessible in the event that emergency disconnection is necessary. • Prior to undertaking any service or maintenance operations or when resetting the GFI, ensure that the MEDIVATORS ADVANTAGE PLUS System is disconnected from the main power supply. If service or maintenance operations are to be conducted on the water system, ensure that the MEDIVATORS ADVANTAGE PLUS System is isolated from the main water supply. For service or service-related questions, contact Medivators Technical Support at 1-800-444-4729 in the United States 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 a minimum of 0.1 micron. A typical water pre-filtration system, such as the one offered by Medivators, filters incoming water through a 1 micron, 0.4 micron, and 0.1 micron series of filters. • The high performance 0.1 micron (absolute rated) water filter included with the reprocessor is highly effective at removing microorganisms and particles larger than 0.1 microns. Appropriate pre-filtration and regular disinfection are required to maintain the performance of this filter. • The routine maintenance schedule recommends replacing the 0.1 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. Detergent Solution MATRIX® Detergent must be used in the cleaning phase of the reprocessing cycle. MATRIX Detergent is low-foaming and formulated to use with medical instruments. MATRIX Detergent has a neutral pH and also bacteriostatic properties to inhibit bacterial growth in the detergent reservoir and detergent lines. 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 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. Disinfectant Solution Use only with RAPICIDE PA High Level Disinfectant (Part A & Part B).

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Endoscope Cleaning and Testing The MEDIVATORS® ADVANTAGE PLUS® System may be used with all types and models of compatible endoscopes and related accessories. Proper endoscope reprocessing is required because endoscopes are inherently complex reusable devices that have the potential to harbor microorganisms that could cross-contaminate other patients. Reprocessing quality depends largely on the thorough cleaning and disinfection of all internal and external surfaces, valves, fittings and accessories where contamination can occur. Improper or insufficient cleaning and disinfection of endoscopes and related accessories may pose a cross-contamination and infection control risk. Manual cleaning of endoscopes must be conducted in accordance with endoscope manufacturer’s instructions, professional guidelines and facility protocols. Endoscopes must be meticulously pre-cleaned immediately after use. The ADVANTAGE PLUS reprocessor contains an optional cleaning cycle as an equivalent alternative to certain manual cleaning steps. The optional cleaning cycle should be used as an enhancement to the overall cleaning process. Additional and/or modified cleaning steps may be required for specific endoscope models when dictated by endoscope manufacturers. Medivators does not promote the complete elimination of manual cleaning prior to automated reprocessing until such practice is endorsed by the professional guidelines. Leak test all endoscopes prior to cleaning and disinfection. Only MATRIX® detergent has been validated for use with the cleaning cycle. It is recommended that cleaning and disinfection take place within one hour after the procedure is completed .

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

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Society of Gastroenterology Nurses and Associates, Inc. 401 North Michigan Ave. Chicago, IL 60611-4267 USA Tel: 800-245-7462 Fax: 312-527-6658 www.sgna.org

Assoc. for Professionals in Infection Control and Epidemiology, Inc. 1275 K Street NW, Suite 1000 Washington, DC 20005-4006 USA Tel: 202-789-1890 Fax: 202-789-1899 www.apic.org

American Society for Gastrointestinal Endoscopy 1520 Kensington Rd., Suite 202 Oak Brook, IL 60523-2141 USA Tel: 630-573-0600 Fax: 630-573-0691 www.asge.org

American Society for Testing and Materials 100 Barr Harbor Dr. West Conshohocken, PA 19428-2959 USA Tel: 610-832-9585 Fax: 610-832-9555 www.astm.org

Association of periOperative Registered Nurses, Inc. 2170 S. Parker Rd., Suite 300 Denver, CO 80231-5711 USA Tel: 800-755-2676 Fax: 303-750-3462 www.aorn.org

Canadian Society of Gastroenterology Nurses & Associates 27 Nicholson Dr. Lakeside, NS B3T 1B3 CANADA Fax: 902-473-4406 www.csgna.com

British Society of Gastroenterology 3 St. Andrews Place Regents Park London NW1 4LB ENGLAND Tel: (+44) (0)20 7387 3534 www.bsg.org.uk

Gastroenterological Nurses College of Australia. PO Box 7345 Beaumaris Victoria 3193 Australia Tel: 1300-788-155 Fax: 1300-799-439 Email: [email protected]

ADVANTAGE PLUS User Manual

Reprocessor Specifications General Specifications The basic reprocessor specifications required for installation and operation of the MEDIVATORS® ADVANTAGE PLUS® system are summarized in Table 1 . Table 1 Reprocessor Specifications Equipment Type Electrical rating Power rating Air pressure range Water pressure range Water flow range Water temperature operating range Humidity range for operation Temperature range for operation Environment Installation/Over voltage category Pollution degree Connection to power supply Dimensions Weight

Laboratory Equipment 100-240 VAC, 50/60 Hz 1000 Watts 87 – 145 psi (6 - 10 bar) 35 - 87 psi (2 - 6 bar) 2 – 8 Liters/minute 30ºC – 40ºC, set mixing valve to 35ºC 20–80%, non-condensing 50°F – 80.6°F (10°C - 27°C) Indoor use only II 2 Cord connection 45”W X 31” D X 62” H (inches) 114 W X 79 D X 157 H (cm) 400 lbs. (182 kg)

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Dimensions and Clearances

Figure 1 Front Dimensions

Figure 2 Side Dimensions & Clearance

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Installation Specifications Electrical The MEDIVATORS® ADVANTAGE PLUS® System must be connected to a single electrical outlet capable of supplying 1000 watts at 100-240 volts AC, 50/60 Hz. The outlet must be properly grounded. Water Potable water is the minimum standard. For optimum performance, water must be delivered at a minimum flow rate of 5 L/min (1.32 gpm) at a dynamic pressure of 30 psi (2 bar) during the basin fill. For optimum performance water must be delivered at 35ºC by use of a mixing valve (required). The mixing valve must be purchased separately and installed by the facility. A back siphonage prevention device must be purchased separately and installed between the water line & the reprocessor to prevent contamination of the water supply in the event of a sudden drop in water pressure. Drain For optimum performance the MEDIVATORS ADVANTAGE PLUS System should be connected to a vented sanitary drain system capable of draining at a minimum rate of 12 L/min (3.17 gpm). Room Ventilation The MEDIVATORS ADVANTAGE PLUS System must be installed in a room with a ventilation system capable of delivering a minimum of 10 air exchanges per hour. An optional vapor management system is available for ductless fume removal. Air The MEDIVATORS ADVANTAGE PLUS System must be connected to an air supply for proper operation. The ADVANTAGE PLUS system includes an air compressor that requires a dedicated 120 VAC, 20 Ampere service or 230 VAC, 10 Ampere service. The air compressor delivers proper air flows and pressure for correct system operation. If the ADVANTAGE PLUS model purchased did not include the air compressor, the system may utilize house compressed air (dry, oil free) which must meet these required air pressure specifications : 58 to 125 PSI with a minimum flow volume of 1.5 CFM, maximum particle size is 5 microns, maximum dew point is 7°C (45°F), maximum oil concentration is 5 mg/m3.

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Storage If the MEDIVATORS® ADVANTAGE PLUS® System will be out of service for an extended period of time, the following steps must be followed: • Remove the side covers, purge all liquids from the system, and then replace the covers. • Place a covering over the unit to protect it from dust and moisture. • The storage temperature must not go below 0°C (32°F), or exceed 60°C (140°F). • The maximum relative humidity must not exceed 80% during storage.

Transport The MEDIVATORS ADVANTAGE PLUS System can be safely moved on a smooth, level floor. However, if you encounter any thresholds or floor level changes, the base cover must be removed to avoid damage. For all other moves, place the MEDIVATORS ADVANTAGE PLUS System on a pallet with a kraft liner. Before moving MEDIVATORS ADVANTAGE PLUS System, ensure the electrical cord, drain line and water supply are either disconnected or are appropriate lengths to accommodate the relocation of the machine.

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Symbols and Icons Symbol

Symbol Meaning

Symbol

Symbol Meaning

LIO software shortcut

Cancel

Management software shortcut

Next

Server software shortcut

Release All

Expert Operation

Start

Cancel

Stop

Menu

Active report, filter applied.

Open/Close

Edit

OK/Enter

Expand

Scroll Down

Export data

Scroll Up

Filter data

Start

Generate report

Stop

Minimize report details

Import data

New

The icons in the grayed area are only used by Service Personnel.

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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. 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. 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 The automated cleaning cycle cannot guarantee the removal of foreign materials such as clips, loops and biliary stents from the endoscope channels. If the endoscope is used in procedures where such accessories are used, the endoscope needs to be pre-cleaned using the appropriate manual cleaning device.

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WARNING Use only fluids approved by Medivators Inc. Check the expiration date of the disinfectant in the reprocessor each day. Never use disinfectant beyond the manufacturer’s expiration date, even if the MRC level is acceptable. Never use disinfectant that tests below the acceptable MRC level, even if it has not yet reached the expiration date. When replacing disinfectant, wear personal protective equipment (clothing, mask, gloves & eye wear). The disinfectant and detergent manufacturers may recommend additional protection. If leaking liquid is present and you suspect it is disinfectant, read and follow the disinfectant instructions before attempting a cleanup. WARNING Ensure that the reprocessor is installed and maintained in a position that allows access to the power cord for emergency disconnection if necessary. 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. RAPICIDE® PA containers must be triple rinsed before disposal.

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NOTE

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