AEROFLEX Ref A1123121 Users Guide Jan 2022 PDF download

AEROFLEX™

Automatic Endoscope Reprocessor

User’s Guide A1123121

A1123121-51 January 2022.

ASP AEROFLEX™ Automatic Endoscope Reprocessor

User’s Guide A1123121

, INC. a

company

, INC.

33 Technology Drive, Irvine, CA 92618 USA a company 33 Technology Drive, Irvine, CA 92618 USA

1-888-STERRAD (USA only) or 949-581-5799 ASP Professional Services ASP International Customer Support (Call your ASP Customer Support Representative) www.asp.com For warranty information, please visit our website or contact ASP Professional Services.

Contents Chapter 1. Introduction�� 1 1.1 Overview�� 1 1.2 Major Components�� 2 1.3 Features�� 3 1.4 Endoscopes�� 4

Chapter 2. For Your Safety�� 5 2.1 Personal Safety�� 5 2.2 Safe Operation �� 6 2.3 Device Safety�� 6 2.4 Safe Maintenance�� 8 2.4.1 Detergent and Disinfectant Use�� 9 2.4.2 Thermal Self-Disinfection�� 9

Chapter 3. Setting Up Your AER�� 11 3.1 Assembling the Connection Tubes�� 11 3.2 Getting Started�� 14 3.2.1 Introduction to Control Panel�� 14 3.2.2 Setting up the System �� 16 3.3 Setting Up Endoscopes through the Control Panel�� 19 3.4 Setting Up Physicians through the Control Panel�� 23 3.5 Setting Up Users Through the Control Panel�� 25 3.6 Configuring the AER System for Network Connectivity�� 27

Chapter 4. Processing Endoscopes�� 29 Important Preparation Information...29 4.1 Steps for Processing Endoscopes�� 29 4.1.1 Procedure Room Pre-Cleaning of the Endoscope�� 29 4.1.2 Manual Endoscope Cleaning�� 29 4.1.3 Loading the Endoscope into the AER�� 30 4.1.4 Leak Testing�� 32 4.1.5 Attaching the Connection Tubes to the Endoscope�� 35 4.1.6 Selecting and Starting a Cycle�� 39 4.2 Cycle Descriptions�� 41 4.2.1 Standard Cycle�� 41 4.2.2 Configurable Cycle �� 41 ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

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4.2.3 Disinfect Only Cycle�� 42 4.2.4 Chemical Self-Disinfection Cycle�� 42 4.2.5 Thermal Self-Disinfection Cycle�� 42 4.2.6 Cycle Stage Descriptions�� 42 4.3 During Cycle in Progress�� 43 4.3.1 Cycle Progress�� 43 4.3.2 Cycle Cancellation�� 44 4.4 Cycle Completion�� 46 4.4.1 Reviewing the Cycle Summary�� 46 4.4.2 Disconnecting Endoscopes from the AER�� 46 4.4.3 Understanding the Report�� 47 4.4.4 Network Transmission�� 48

Chapter 5. Editing Cycles�� 49 5.1 Overview�� 49 5.2 Editing the Configurable Cycle�� 49 5.3 Editing the Disinfect Only Cycle�� 52

Chapter 6. Routine Maintenance�� 53 6.1 Overview�� 53 6.2 Daily Maintenance�� 53 6.3 Weekly Maintenance�� 54 6.4 Planned Maintenance�� 54 6.5 Maintenance Before and After a Planned Idle Period (longer than 2 weeks)�� 54 6.6 Replacing Solutions�� 55 6.6.1 Replacing the Disinfectant, MRC Reagent and Including Neutralization if Required�� 55 6.6.2 Replacing the Detergent�� 62 6.6.3 Refilling the Alcohol Bottle�� 65 6.6.3.1 Alcohol dispense verification�� 66 6.7 Self-Disinfecting the Reprocessor�� 67 6.7.1 Thermal Self-Disinfection�� 67 6.7.2 Chemical Self-Disinfection�� 69 6.8 Replacing the Water Filter Cartridge�� 72 6.9 Replacing Wall Mounted Water Filtration System Cartridge�� 77 6.10 Replacing Printer Paper�� 77

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ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

Chapter 7. Additional Features�� 79 7.1 Placing the Reprocessor in Standby Mode�� 79 7.2 Setting Date and Time�� 80 7.3 Setting up System Configuration�� 81 7.4 Adjusting Brightness�� 82 7.5 Setting up Advanced Settings�� 83 7.6 Transfer Cycle History Data�� 84 7.7 Draining the Basin �� 85 7.8 Moving the AER�� 86 7.9 Managing Scopes, Users, Physicians and Network Setup�� 87 7.9.1 Managing Endoscopes�� 87 7.9.2 Managing Physician Details�� 89 7.9.3 Managing Users�� 91

Chapter 8. Troubleshooting�� 95 8.1 Cycle Interruption�� 95 8.2 Error Messages and Remedies�� 95 8.3 Alert Messages and Remedies�� 97

Chapter 9. Specifications�� 99 9.1 Physical�� 99 9.1.1 Dimensions�� 99 9.1.2 Environmental�� 99 9.1.3 Power�� 99 9.2 Water, Filters, and Fluids�� 99 9.3 EMC Standards�� 100 9.4 Safety Standards�� 100 9.5 Labels and Symbols�� 100

Appendix A. User’s Network Connection Information Guide�� 103 Appendix B. Consumables and Accessories �� 133 Appendix C. Software License Agreement�� 135

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ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

Introduction

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Chapter 1.

Introduction 1.1 Overview The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER), product code 28000 with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO‑OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER. The minimum recommended concentration (MRC) of ASP AERO‑OPA™ ortho‑Phthalaldehyde Solution is automatically checked and verified by the AER for every cycle using an integrated MRC monitor and reagent. The proper preparation of an endoscope is key to successful reprocessing in the AER. You should carefully follow your hospital or healthcare facility’s procedures for leak testing, cleaning, rinsing, processing, storing, and drying endoscopes. Endoscopes must be thoroughly cleaned prior to placing them in the AER. This guide presents important information needed to operate and maintain the ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor. The AER is designed to provide high-level disinfection for flexible, submersible endoscopes. High-level disinfection requires that the AER be used with ASP AERO‑OPA™ Solution per its Instructions for Use. After an endoscope is manually cleaned according to its manufacturer’s recommended procedures, it is loaded into the AER. After starting the reprocessing cycle, the AER displays its progress during the cycle and signals that the cycle is complete on the control panel and with an audible tone. Sensors in the AER detect when routine and/or non-routine maintenance must be done. The AER provides visual notification of required actions. IMPORTANT! The photos and graphics of the AER, screens and printouts are for reference only. Your AER may look different or present different screens and/or printed messages.

ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

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Introduction

1.2 Major Components Overflow Drain Reprocessing Basin Channel Ports Basin Lid

Control Panel RFID Receiver

(B)

Water Filter Alcohol level Indicator Solutions Compartment Door

Detergent Bottle

Alcohol Bottle (A)

Door Handle

(C)

Solutions Compartment

Figure 1. (A) Automatic Endoscope Reprocessor (AER). (B) Reprocessor Basin. (C) Solutions Compartment.

System Description: The AER produces consistent results that remove the variability in manual endoscope reprocessing, and is a closed system that reduces user exposure to chemicals. The AER’s primary components are described below: Reprocessing Basin – The reprocessor’s basin contains the endoscope and reprocessing solutions during the reprocessing cycle. The endoscope is connected to the channel ports for proper reprocessing. Basin Lid – The self-locking lid allows visual confirmation of the reprocessing steps, while protecting the user from the solutions in the basin. Solutions Compartment – The solutions compartment holds detergent, alcohol, MRC reagent, and water filter cartridge. A door on the front of the reprocessor allows access to the solution compartment. A window is provided on the door with a level indicator to check the alcohol quantity.

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Introduction

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Control Panel – The touch screen control panel in the center of the cabinet top provides information on the system’s status, and enables a variety of user interactions with the system. The touch screen of the control panel can also be controlled with a soft tipped stylus. RFID Receiver – The RFID receiver is located on the front panel of the system, just below the control panel. The RFID tags on the disinfectant and detergent bottles are scanned by the RFID receiver. Rear Panel – The rear panel provides connection points to the hospital or healthcare facility’s utilities and network. Disinfectant Tank – The disinfectant tank holds the OPA Disinfectant between cycles. It is emptied and refilled through the basin by an interactive touch screen control panel. Printer – The printer provides a printed report at the end of each cycle. The printer can be mounted on either side of the system or placed on a nearby surface.

1.3 Features The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor has several features designed to deliver consistent, reliable, reprocessing. These features include: • • • • • • • • • •

Automatic Integrated MRC Monitor Automatic Temperature Control Custom Cycle Selection for Duodenoscopes Network Connectivity / Electronic Records Management Color Touch Screen Control Panel Automatic Locking Lid Authentication of Disinfectant and Detergent with RFID Technology Automatic System Self-Disinfection Automatic OPA Neutralization Endoscope Connection Diagrams

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Introduction

1.4 Endoscopes ü Note: Not all endoscope models are qualified for reprocessing in the AER. Please contact your representative for a list of qualified endoscopes and applicable connection diagrams. The AEROFLEX AER can be used to process semi-critical submersible flexible endoscope models of a variety of endoscope types, although not all models of these types are qualified. Qualified models are included in the following types: • • • • •

Respiratory tract endoscopes Urinary tract endoscopes Gastro-intestinal endoscopes Duodenoscopes with a sealed elevator channel Duodenoscopes with an open elevator channel

Not all endoscope models of these types are qualified. Please contact your representative for endoscope model-specific information.

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ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

For Your Safety

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Chapter 2.

For Your Safety Your safety is of primary concern to ASP. This section provides information on safely using the AER. You must read, understand, and use the information in this chapter before operating the reprocessor. Also, always pay attention to the warnings, cautions, and notes throughout this guide. This information is for your safety and to ensure that you receive the most benefit from the safe operation of your reprocessor. Only trained, experienced technicians, who are fully acquainted with the AER, should perform repairs or adjustments.

2.1 Personal Safety

• MAKE SURE YOU HAVE AND USE PERSONAL PROTECTIVE EQUIPMENT (PPE) AT A MINIMUM GLOVES, EYE PROTECTION, IMPERVIOUS GOWN, FACE SHIELD OR SIMPLE SURGICAL MASK THAT WILL NOT TRAP VAPORS. THE SOLUTIONS USED IN THE AER CAN BE IRRITATING TO EYES AND SKIN AND MAY CAUSE SENSITIZATION. The solutions may also damage clothing. Refer to their manufacturer’s safety instructions when using these solutions. All personal safety precautions described in this chapter must be used when performing routine maintenance on the AER. • You must clean up spills IMMEDIATELY. Follow spill clean-up procedures as recommended by the solution manufacturers and any Safety Data Sheets (SDS) information for spill clean-up in your hospital or healthcare facilities. Take appropriate precautions to avoid slips and falls. • ELECTRICAL SHOCK HAZARD! If the reprocessor has been turned off, or there has been a power failure and you must turn on the reprocessor, make sure the power switch is dry and that there are no loose wires. DO NOT stand in a moist area when turning on the power. • The reprocessor should only be operated by those who have received proper training. Do not operate the reprocessor unless you have been trained in the safe use of the AER and in the safe handling of the disinfectant. Training should be documented in accordance with your hospital or healthcare facility’s policies and procedures. • Use caution when touching the lid. During the thermal self-disinfection cycle, the temperature of the system lid can increase to 55°C (131°F) or higher. • Use caution when opening the printer. The areas around the print head become very hot during and just after printing; do not touch them.

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2.2 Safe Operation

• If a cycle is stopped by the user, the cycle should be repeated prior to removing the endoscope from the reprocessor. Follow proper personal safety procedures detailed in the previous section. • If a cycle is stopped due to an error or failure and cannot run to completion, the endoscope and the inside of the reprocessor may not be high-level disinfected and complete reprocessing is needed. Refer to the endoscope manufacturer’s recommendations for reprocessing. • When processing an endoscope in the AER, follow the endoscope connection procedures established by Advanced Sterilization Products. • Never place objects on top of the reprocessor lid.

WARNING!

ELECTRICAL SHOCK HAZARD! DO NOT LET THE POWER PLUG GET WET OR IT WILL CAUSE ACCIDENTS FROM SHOCK. TO AVOID THE RISK OF ELECTRIC SHOCK, DO NOT TOUCH THE POWER PLUG WITH WET HANDS OR TOUCH THE OUTLET DIRECTLY.

2.3 Device Safety

• DO NOT ATTEMPT TO PROCESS ITEMS OR MATERIALS THAT DO NOT COMPLY WITH THE GUIDELINES SPECIFIED IN THIS GUIDE. In addition, you should read the endoscope manufacturer’s instructions, or call your representative to determine whether an endoscope can be reprocessed in the AER. • Make sure the reprocessor is positioned so that you have easy access to the back of the system, to access the power switch, and to disconnect the power cord from the reprocessor if necessary. • If relocation of the reprocessor is required, contact your representative to ensure that proper installation guidelines are followed. • Make sure endoscopes and their parts are correctly placed in the basin and basket. Incorrect placement could result in inadequate disinfection. • Make sure all endoscope channels are correctly and securely connected to the channel sets and connected to the fittings in the basin. Refer to the endoscope connection diagram provided by ASP for specific information for connecting a particular endoscope. • Perform a periodic inspection of all the channel sets for integrity. Look for both lengthwise and cross-wise cracks, nicks, holes, or other damage to the tubing or o‑rings. Gently tug at the connectors at both ends of the tube; the connectors should remain firmly attached to the tubing. Replace any connection tubes that are damaged or have loose connectors.

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For Your Safety

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• Take care when closing the lid and follow safe opening and closing procedures of solutions compartment door of the reprocessor to prevent injury or damage. • Endoscopes and associated items are often heavily contaminated. Follow local hospital or healthcare facilities procedures for handling contaminated devices. • Ensure that inorganic materials, such as clips and stents, are removed from the channels prior to processing in the AER system. • Barcode scanner must be installed by the field service engineer. System contains RFID reader module with FCC ID: PJMISCM02 WARNING! (PART 15.21) RISK OF NON-COMPLIANCE. Changes or modifications not expressly approved by Advanced Sterilization Products could void the user’s authority to operate the equipment. Manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. System is configured with IC Certification Number: 6633A-ISCM02 FCC Rules and Industry Canada (IC) Regulatory Information Compliance Statement (Part 15.19) The equipment device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received including interference that may cause undesired operation. Compliance Statement (Part 15.105(b)) ü Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

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Class A digital device notice “CAN ICES-3(A)/NMB-3(A)” RF Radiation Exposure Statement This equipment complies with the FCC/IC radiation exposure limits set forth for portable transmitting devices operation in a controlled environment. End users must follow the specific operating instructions to satisfy RF exposure compliance. The equipment should only be used where there is normally at least 20 cm (7.9 in.) separation between the antenna and all person/user. This transmitter must not be co-located or operation in conjunction with any other antenna or transmitter. Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.

2.4 Safe Maintenance

• MAKE SURE YOU HAVE AND USE PERSONAL PROTECTIVE EQUIPMENT (PPE) AT A MINIMUM GLOVES, EYE PROTECTION, IMPERVIOUS GOWN, FACE SHIELD OR SIMPLE SURGICAL MASK THAT WILL NOT TRAP VAPORS. THE SOLUTIONS USED IN THE AER CAN BE IRRITATING TO EYES AND SKIN AND MAY CAUSE SENSITIZATION. The solutions also may damage clothing. Refer to the SDS when using these solutions. All personal safety precautions described in this chapter must be used when performing routine maintenance on the AER. • Immediately clean up spills. Follow spill clean-up procedures as recommended in the disinfectant instructions for use and by your hospital or healthcare facilities. • AER installation and servicing, beyond routine maintenance, must be performed by ASP-authorized service technicians. Routine maintenance must be performed only by ASP-trained personnel according to the maintenance guidelines in this guide. • WARNING! ELECTRICAL SHOCK HAZARD! The reprocessor power plug requires grounding and it may cause shock or fire if it is not connected to a properly grounded outlet. Do not use power strips, extension cords, etc. to connect the reprocessor to the main power supply. • WARNING! ELECTRICAL SHOCK HAZARD! Do not let the power plug get wet or it will cause accidents from shock. To avoid the risk of electric shock, do not touch the power plug with wet hands or touch the outlet directly. • The hospital-grade outlet socket in the medical facility where the unit is to be connected should be of sufficient capacity (more than 1.5 kVA). If a lower capacity socket is used, it may cause a fire.

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ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

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• Make sure the reprocessor is positioned to allow easy access to the power switch and the power cord. Do not push the back of the unit against a wall or pillar. The power cord can break and cause electric shock or fire. • Do not force the power cord to bend, do not step on it, or place anything heavy on it.

2.4.1 Detergent and Disinfectant Use In addition to the safety measures described in the Personal Safety and Safe Maintenance sections, use the following disinfectant and detergent to ensure safe use of the AER: The reprocessor has been validated for use with the following products: • • • •

Disinfectant: ASP AERO‑OPA™ ortho‑Phthalaldehyde Solution Detergent: ASP AEROZYME™ XTRA Multi Enzymatic Detergent Reagent: AUTOSURE™ MRC Reagent Isopropanol: 70%

ü Note: DO NOT use consumables beyond their expiration date. Refer to the respective product’s IFU (Instructions for Use) for bottle/container disposal. Prior to use perform a visual inspection of the consumable bottle, cap, and seal. DO NOT USE if the consumable is damaged. Refer to the information contained in the SDS of the respective solutions used. SDS are available on www.asp.com or by contacting your representative. WARNING!

DO NOT USE ASP AERO‑OPA™ ORTHO‑PHTHALALDEHYDE SOLUTION IF IT HAS BEEN STORED BEYOND ITS EXPIRATION DATE OR HAS BEEN STORED AT TEMPERATURES ABOVE 30°C (86°F), AS THIS MAY RESULT IN PRODUCT NOT MEETING MINIMUM RECOMMENDED CONCENTRATION.

2.4.2 Thermal Self-Disinfection The temperature of the basin lid during the Thermal self-disinfection process will be above 55°C (131°F); avoid touching the lid during the cycle.

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ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

Setting Up Your AER

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Chapter 3.

Setting Up Your AER 3.1 Assembling the Connection Tubes AER uses cleaning adapters provided by the endoscope medical device manufacturer (MDM) in combination with the AER connection tubes. The following steps serve as a guide to assemble the AER connection tubes for use. ü Note: Verify the assembled connector matches the endoscope model in the connection diagram before processing endoscopes. 1. Consult the AER Connection Diagram for your endoscope model provided by ASP. Contact your representative if necessary.

Figure 2. Generic illustration of a connection diagram.

2. Identify the endoscope manufacturer’s cleaning adapters and ASP connection tubes from the Connection Diagram, and have them ready to assemble if applicable. 3. If necessary, assemble the connection between the ASP connection tubes to the manufacturer’s cleaning adapter.

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Setting Up Your AER

4. If disassembly of the manfacturer’s cleaning kit is necessary, follow the general steps below: a. Remove the manufacturer’s cleaning adapter from the manufacturer’s tubing or cleaning kit.

Figure 3. Generic picture of a cleaning kit to disassemble.

b. If applicable, slide the endoscope connection sleeve onto the connection tube, pushing it onto the tubing about 2 cm (0.79 in.) (use sleeve as needed).

Figure 4. Slide the connection sleeve onto the tube.

c. Carefully, firmly push the tubing onto the cleaning adapter fitting. You may need to wet the fitting or the the tubing to make it easier to connect.

Figure 5. Push the tubing onto the fitting.

d. Push the connection sleeve over the fitting.

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Figure 6. Push the connection sleeve over the fitting.

e. Use the assembled connection tubing to connect the endoscope to the AER, following the instructions in the endoscope connection diagram.

Figure 7. Generic example of a complete ASP/MDM connector assembly.

f. Retain the newly assembled connector for reuse with the AER. CAUTION:

Do not disassemble and reassemble the ASP/MDM connector assembly, due to possible damage, wear or tear to the tubing.

5. Repeat this process for leak test adapter.

Figure 8. Leak test adapter.

6. If additional ASP tubing is required, contact your representative.

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3.2 Getting Started 3.2.1 Introduction to Control Panel The AER software’s Graphical User Interface (GUI) uses several common screen elements to simplify your interaction with the system. The sample control panel screen is shown below.

Header Panel

Information block

Footer Panel Active button

Inactive button

Figure 9. Sample Control Panel screen.

CAUTION:

Do not touch the screen with sharp objects such as pens or pencils. Use only fingers or a soft tipped stylus. Avoid touching the screen with contaminated gloves.

Standard Header Panel: In the Standard Header Panel, the word or phrase at the far left end identifies the screen or group of screens that is currently displayed. The center of the panel shows the current time of day in the format you selected during system setup. The far right of the panel shows the current date in the format you selected during system setup.

Figure 10. Standard Header Panel.

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ASP AEROFLEX™ Automatic Endoscope Reprocessor User’s Guide

Advanced Sterilization Products

AEROFLEX Systems

AEROFLEX Ref A1123121 Users Guide Jan 2022