EVOTECH Users Guide Jan 2012

EVOTECH® Endoscope Cleaner and Reprocessor User’s Guide REF 99902

33 Technology Irvine, California 92618 USA 1-888-783-7723 USA 001-949-581-5799 International 1-800-255-2500 (USA Only Consumables Orders) www.aspjj.com

© Division of Ethicon, Inc. 2007-2012. All rights reserved. EVOTECH® Endoscope Cleaner and Reprocessor (ECR), CIDEX® OPA Concentrate Solution, and CYDEZYME® XTRA Multi-Enzymatic Detergent are registered trademarks of Advanced Sterilization Products (ASP). All other products mentioned in this publication are trademarked by their respective corporations. Reproduction, adaptation, or translation of this publication without prior written permission is prohibited.

Contents Chapter 1. Introduction ...5 Major Components ...6 System Description ...7 Additional Features ... 8 Control Panel Description ... 9 Displayed Information and Cycles ...12 Displayed Operations ... 12 Cycle Descriptions ... 13 Cycle Stages ... 14 Additional Displays ... 16 Control Panel Display Buttons ... 17 Typical Cycle Displays ...19 Starting a Cycle – No Operator ID Required ... 24 Additional Displays ...25 Help ... 25 View Cycle ... 26 Cycle Printout ... 26 System Utilities ...27 Print 24-Hour Reports ... 28 Cycle History ... 28 Electronic Cycle Data ... 29 Endoscope Setup ... 30 System Self-Disinfect ... 32 User Administration ... 33 System Configuration ... 35 Cycle Setup ... 36 Edit Physician/Procedure ... 37 System Status ... 38 Date and Time ... 39 Network Settings ... 40 System Diagnostics ... 40 Planned Maintenance ... 42 Chapter 2. For Your Safety ...43 Personal Safety ...43 Safe Operation ...44 Device Safety ...44 Safe Maintenance ...46 Detergent And Disinfectant Use ...46

EVOTECH® ECR User’s Guide

1

Chapter 3. Processing Endoscopes ...47 Important Preparation Information ...47 Steps for Processing Flexible Endoscopes ... 48 Operating the Basin Lids ...50 Connection Diagrams ...51 Connection Diagrams for Currently Setup Scopes ... 51 Exporting Connection Diagrams to a USB Flash Drive ... 52 Printing Connection Diagrams ... 53 Using Connection Diagrams ... 53 Loading and Connecting an Endoscope ...55 Unloading an Endoscope ...59 Chapter 4. Running Cycles ...61 Cycle Summary ...61 Leak Test ... 62 Pre-Rinse Stage ... 62 Wash Stage (if enabled) ... 62 Disinfection Stage ... 63 Alcohol Flush ... 63 Final Leak Test ... 63 Starting a Cycle with a Required ID ... 64 Disinfect Only Cycle ... 68 Starting a Cycle - No ID Required ... 69 Disinfect Only-No ID Required ... 70 Completing A Cycle ... 71 Canceled Cycle ... 73 Following The Last Cycle of The Day ...74 Chapter 5. Routine Maintenance ...75 Overview ...75 Cleaning the Edge Seals ...75 Cleaning the Touch Screen ...76 Replacing Solutions ...76 Replacing the Disinfectant ... 78 Replacing the Enzymatic Detergent ... 80 Replenishing the Alcohol ... 81 Changing the Internal 0.2 Micron Filters ... 82 Self-Disinfect Cycle ...84 Water Conductivity Improvement ... 84 Running the Self-Disinfect Cycle ... 84 Additional Servicing ...88 Removing Items from the Coarse Screen ... 88 Cleaning the Drip Tray ... 90 Printer Paper Replacement ... 90 2

EVOTECH® ECR User’s Guide

Chapter 6. Troubleshooting ...91 Appendix A. Specifications ...97 Physical ...97 Size ... 97 Temperature, Humidity, and Elevation ... 97 Noise Output ... 97 Main AC Power ... 98 Water Temperature, Pressure, and Hardness ...98 EMC Standards ...98 Safety Standards ...98 Labels and Symbols ...99

EVOTECH® ECR User’s Guide

3

4

EVOTECH® ECR User’s Guide

Chapter

1

Introduction This guide presents important information you need to operate and maintain the EVOTECH® Endoscope Cleaner and Reprocessor (ECR) from Advanced Sterilization Products (ASP). The EVOTECH® ECR has unique features designed to deliver consistent, reliable, quality reprocessing. These features include: ♦ an automatic cleaning cycle to replace manual cleaning, when selecting a cycle with a cleaning stage; ♦ an automatic leak detection system; ♦ an automatic blockage detection system; ♦ individual qualification of scopes; ♦ rapid turnaround time of 33 minutes, or less, under nominal conditions; ♦ single-shot technology to ensure fresh disinfectant and detergent with each cycle; ♦ MEC monitoring to ensure minimum effective concentration of CIDEX® OPA Concentrate Solution.

EVOTECH® ECR User’s Guide

5

1

Introduction

Major Components The EVOTECH® Endoscope Cleaner and Reprocessor is designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. High-level disinfection requires that the system be used with CIDEX® OPA Concentrate Solution, manufactured by ASP, per its Instructions for Use. Use of disinfectant other than CIDEX® OPA Concentrate Solution may void your warranty. The system has been validated by ASP and cleared by the Food and Drug Administration (FDA) for use with CIDEX® OPA Concentrate Solution. After procedure room pre-cleaning, one endoscope is independently loaded into either basin. The desired cycle is then selected and the highlevel disinfection process is started. If a cycle without a wash stage is selected, or if the endoscope cannot be automatically cleaned by the EVOTECH® ECR, manually clean the scope prior to reprocessing.

Lids showing spray arm guard

Generic Endoscope Connection Diagram

Lid Window

Basins

Printer

Alcohol Fill Port Close Lid Button (duplicate on other side)

Control Panel

Service Doors

Foot Pedals

Figure 1. EVOTECH® ECR.

6

EVOTECH® ECR User’s Guide

Introduction

1

System Description The EVOTECH® Endoscope Cleaner and Reprocessor is composed of two independently operated sides, each with a basin. Both processing basins are operated using the control panel. One basin can be idle while the other is in use, or the basins can be operated simultaneously. The EVOTECH® ECR is a closed system to reduce user exposure to chemicals. It produces consistent results that remove the variability in processing. The primary components of the system are shown in the previous figure and detailed as follows: ♦ Processing Basins: One endoscope is loaded into each processing basin. The basin contains channel connectors for connecting the tubing sets to an endoscope. ♦ Basin Lids: Each basin lid features a seal and a rotating spray arm. Each lid also has a window, allowing you to view the activity in the basin. ♦ Service Doors. A door on each side of the front panel can be opened to perform routine maintenance, and replenish detergent and disinfectant. The service doors can be locked so that only authorized personnel have access to the detergent, disinfectant, and bacterial filters. ♦ Seismic Restraints: Earthquake anchor mounting locations are on the left and right sides of the system. ♦ Alcohol Fill Port: The alcohol fill port is used to fill the alcohol reservoir with 70% isopropyl alcohol. Alcohol facilitates drying of the endoscope channels. The system notifies you when this solution needs to be replenished. ♦ Barcode Scanner (optional): The barcode scanner allows you to quickly enter information relating to the endoscope, the operator, the physician, and the patient. If you normally choose information from a drop down menu on the reprocessor, the barcode scanner cannot be used for entering data. ♦ Endoscope Connection Diagram: Information on how to connect an endoscope is shown by a generic endoscope diagram located on the front of the unit. Specific connection diagrams are available for all qualified endoscopes. ♦ Control Panel: The system is operated using a control panel in the center of the top front panel. The following section contains detailed information on the control panel and the information it displays. Note:

EVOTECH® ECR User’s Guide

Not all endoscopes can be qualified for reprocessing in the EVOTECH® ECR. Please check with your ASP Representative if you have questions about specific endoscopes.

7

1

Introduction

Additional Features ♦ Foot Pedal - The foot pedal allows ergonomic opening of the lids while preventing potential cross-contamination from hands. ♦ Printer - Prints out complete records of all EVOTECH® ECR cycles for proper documentation control. ♦ Cycle Tracking - Electronic documentation is downloadable to allow users to track the history of each cycle. This information is downloadable by: >> Ethernet Connector - Allows transfers of data to facility tracking systems. >> USB Connector - The location where the optional bar code scanner is attached. A USB hub can be attached to this location to provide multiple ports for USB compatible devices. ♦ Audio Notification - An audible alert notifies users when the cycle has completed or cancelled. The volume of the alert tone can be adjusted by an ASP service representative. ♦ Connection Testing - The system stops the cycle if a channel is not properly connected. This ensures that each scope receives the proper exposure to high-level disinfection during the cycle. (This test may be disabled depending on the type of scope selected.) ♦ MEC Monitoring - Automated Minimum Effective Concentration (MEC) testing where manual testing using test strips is not required. This assures the proper concentration of disinfectant without user interaction. ♦ Spray Arm and Spray Arm Guard - Penetrating spray from the spray arm allows for fluids to reach the nooks and crannies of the endoscope. The spray arm guard prevents scopes and connector sets from being struck by the spray arm. ♦ Positive Pressure Reprocessing for Repair - Maintenance of positive pressure to avoid fluid invasion and damage to the endoscope while it is being safely reprocessed. This feature may be disabled depending on the scope selected. ♦ CIDEZYME® XTRA Multi-Enzymatic Detergent - A multienzyme detergent that facilitates the cleaning of endoscopes. ♦ EVOTECH® ECR Water Filtration Unit with Chlorine Removal - A separate, wall-mounted unit, required for use with the EVOTECH® ECR. This water filtration system removes particulates and chlorine from the incoming water supply to prolong the life of the EVOTECH® ECR.

8

EVOTECH® ECR User’s Guide

Introduction

1

Control Panel Description The EVOTECH® ECR control panel consists of a display that is activated by touching the screen in the desired location. The control panel displays system data, and also functions as a keyboard when needed. A standard keyboard is displayed when keyboard-type entry is needed. You can select options and operate the system through this control panel. Caution: Do not touch the screen with sharp objects such as pens or pencils.

Figure 2. Touch the screen to begin. In this display the system is idle. The color-coding for the channel sets is shown on every Start screen when that basin is idle.

The above display appears when the system is idle or after it is first turned on. Each side of the control panel directs the action for a separate basin. Touch either side to start the endoscope processing procedures. The displays described on the following pages are designed to give you a short overview of the function of the EVOTECH® ECR and the displays you will see most often. Go to Chapter 4 for information on how to run a cycle.

EVOTECH® ECR User’s Guide

9

1

Introduction

Process Endoscope Replace Solutions Utilities Logout

Basin B (idle)

Figure 3.Main Display.

The main display appears after you have touched the start display and logged in (if required). At this point you have a number of choices, depending on your log in privileges you can: process an endoscope; start the instructions to replace solutions; use the system utilities; or log out. The following section features the “Process Endoscope” display, which is the one you will use the most.

10

EVOTECH® ECR User’s Guide

Introduction

1

Operator Name (appears only if operator is logged in) Scope ID Patient ID Physician ID Procedure ID

Start

Basin B (idle)

Figure 4.Endoscope Processing Display.

The above display is typical of those you will see when processing an endoscope. Note that on this display, the information is for the endoscope in Basin A. Basin B can simultaneously have entirely different endoscope information. Your ID, if you have logged in, appears at the top; then the Scope ID information is displayed. Scope ID information is selected from a predefined database. If your protocols require it, you would also enter Patient ID (either typed in or scanned via the optional barcode scanner), enter or select a Physician ID, and enter or select a Procedure Type. The other buttons on the above display are the Basin Lid buttons, the Cancel button, and the Start button.

EVOTECH® ECR User’s Guide

11

1

Introduction

Displayed Information and Cycles Displayed Operations Following is a brief list of the operations the system performs and some of the pertinent information shown on the main cycle display. Wash On

Alcohol On

Disinfect

Cycle Time

Cancel

Start

Figure 5.Cycle In Progress. Wash, Disinfect, and Alcohol Flush (typical default cycle) have been chosen.

Note the above display. The various stages of the processing cycle are shown in different colors. Wash is blue, Disinfect is purple, Alcohol is yellow, and the Test phases are light blue/green depending on the system configuration. Wash and Alcohol are selectable functions. That is, you can turn them off or on by touching the color-coded symbols. This allows you to create different cycle “configurations.” ♦ If you use the typical default cycle, you can clean, disinfect and alcohol flush your endoscope. (Your default cycle may be different and is usually set at installation.) ♦ If you touched Wash (to turn it off), you would then only disinfect and alcohol flush your endoscope. Turning off the wash cycle requires that the scope be manually cleaned prior to processing. ♦ If you touched Wash (to turn it off) and Alcohol (to turn it off), you would only disinfect your endoscope. Turning off the wash cycle requires that the scope be manually cleaned prior to processing. If you turn off Alcohol, you would need to follow your facility’s procedures regarding alcohol processing.

12

EVOTECH® ECR User’s Guide

Introduction

1

♦ If Wash was turned on, and alcohol was turned off, you would clean and disinfect your endoscope without the alcohol flush. Note: Endoscopes that cannot be automatically cleaned by the EVOTECH® ECR must be manually cleaned and tested for leaks and channel blockages before reprocessing. When connecting these endoscopes to the reprocessor, ensure that all connectors are properly attached, as the connections may not be automatically checked by the system. Please refer to the appropriate endoscope connection diagrams.

Cycle Descriptions Following is a brief overview of the processing cycles and the selfdisinfection cycle on the EVOTECH® ECR. WARNING! IF A CYCLE CANCELS FOR ANY REASON WHILE REPROCESSING AN ENDOSCOPE, THE PROCESS IS INCOMPLETE AND THE ENDOSCOPE MUST NOT BE USED ON PATIENTS.

Wash, Disinfect, and Alcohol Flush (typical cycle) As part of this cycle, the EVOTECH® ECR performs a Wash stage, a Disinfection stage, and an Alcohol Flush. The use of an alcohol flush following high-level disinfection is recommended by the Society of Gastroenterology Nurses and Associates (SGNA) to promote drying of the endoscope channels.

Wash and Disinfect Cycle Use this cycle if your facility has a protocol that does not require the use of an alcohol flush, or if an alcohol flush of the flexible endoscope channels will be performed manually. Note: The SGNA recommends the use of an alcohol flush to encourage endoscope channel drying both between patient procedures and prior to storage. Refer to the SGNA 2008 Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes for more information.

Disinfect and Alcohol Flush Cycle Use this cycle if your facility’s endoscope processing protocol dictates the use of the EVOTECH® ECR only for high-level disinfection and alcohol flush. When selecting this cycle, endoscopes must first be manually cleaned prior to being placed in the EVOTECH® ECR.

EVOTECH® ECR User’s Guide

13

1

Introduction

Disinfect Only Cycle Use this cycle if your facility has a protocol that allows flexible endoscopes to be manually cleaned and the EVOTECH® ECR is used only for high-level disinfection. The protocol should also state your facility’s requirement for an alcohol flush (either manually performed or omitted for specified reasons). When selecting this cycle, endoscopes must first be manually cleaned prior to being placed in the EVOTECH® ECR.

Self-Disinfection Cycle The self-disinfection cycle is accessed from the utilities display. ASP recommends that this cycle be run on each basin of the EVOTECH® ECR at least once per week, or per your facility’s protocol. This cycle disinfects all the fluid pathways of the EVOTECH® ECR through the use of hot water (>70° C) and a cool-down period. This cycle is intended to reduce the buildup of biofilm in the EVOTECH® ECR fluid pathways and in the 0.2 micron filters.

Cycle Stages These cycle stages are performed by the system after endoscope precleaning at the bedside. ♦ Leak Detection- The endoscope is tested for gross leaks at the start of the cycle, before any solutions are introduced into the endoscope. When the system has determined that the endoscope can be safely reprocessed, the EVOTECH® ECR cycle begins. Leak monitoring continues throughout the cycle. A positive pressure is maintained throughout the cycle to prevent fluid invasion during the cycle. This function cannot be disabled. Known leaking scopes must be reprocessed following manufacturers’ guidelines. This test may be disabled depending on the scope selected. ♦ Pre-rinse –Filtered (0.2-micron), bacteria-free water is pumped through the endoscope channels. This removes any gross contaminants on or in the endoscope channels. The pre-rinse cannot be turned off. ♦ Wash - Detergent solution is pumped through the endoscope channels by individual channel pumps and circulated over the surface of the endoscope via the rotating spray arm. Connection and blockage tests are performed in wash or rinse stages, depending on the selected cycle. If you choose to manually clean the endoscope, you can choose not to automatically clean the endoscope by turning the Wash Cycle off. Connection and blockage tests may be disabled depending on the scope selected. ♦ Rinse - Detergent solution is rinsed from the endoscope surface and channels using 0.2-micron filtered water. The rinse cannot be turned off.

14

EVOTECH® ECR User’s Guide

Introduction

1

♦ Disinfect – High-level disinfection is achieved by exposing all endoscope channels and external surfaces to CIDEX® OPA Concentrate Solution. During this step, the endoscope is checked for blockages and if a blockage is detected, the cycle is cancelled. The disinfection stage cannot be turned off. During the disinfection stage, the minimum effective concentration of the disinfectant is automatically measured. The result of the measurement is saved in the cycle history file and is included on the printout. ♦ Final rinses – Filtered bacteria-free water (0.2 micron filter) is pumped through the endoscope channels. The rotating spray arm circulates the filtered water over the surface of the endoscope. This removes any remaining high-level disinfectant. The final rinses cannot be turned off. Endoscope connection integrity is checked at this stage. The exception is for endoscopes where this feature has been turned off. ♦ Alcohol Flush – 70% isopropyl alcohol is flushed through the endoscope channels prior to cycle completion. You may choose not to perform the alcohol flush (turn alcohol flush off) based on your facility’s policy. ♦ Leak Test – A leak test at the beginning of the cycle checks for large leaks that would prevent the endoscope from being reprocessed. The endoscope is pressurized throughout the cycle to prevent invasion of liquid. Just prior to the end of the cycle, the leak rate is measured in mbar/min. this value is contained in the printed cycle report, and indicates the rate at which air leaked from the endoscope. Depending on the scope selected, this feature may be disabled. ♦ Time, Pressure, and Temperature – The temperature is shown at the top left-hand side of the display, the pressure at the top right, and the remaining cycle time is shown in the center of the display. The time refers to the length of time remaining in the cycle. Temperature is the temperature of the solutions in the basin. Pressure is the pressure of the air in the endoscope body. ♦ Minimum Effective Concentration (MEC) Monitor – The EVOTECH® ECR contains an integrated MEC Monitor. The MEC Monitor checks the concentration of the diluted single shot “in-use” CIDEX® OPA Concentrate Solution to make sure the concentration is sufficient to ensure high-level disinfection during the disinfection stage of the cycle. If the concentration does not meet preset limits, the cycle in progress will cancel. WARNING! IF A CYCLE CANCELS, FOR ANY REASON, WHILE REPROCESSING AN ENDOSCOPE, THE PROCESS IS INCOMPLETE AND THE ENDOSCOPE MUST NOT BE USED ON PATIENTS.

EVOTECH® ECR User’s Guide

15

1

Introduction WARNING! WHEN PROCESSING SCOPES FOR WHICH LEAK TEST, BLOCK TEST, AND CONNECTION CHECKING HAVE BEEN DISABLED, YOU MUST PERFORM THESE FUNCTIONS MANUALLY, AS DESCRIBED LATER IN THIS GUIDE.

Additional Displays The EVOTECH® ECR displays a wide variety of information for you in addition to what has been presented in the previous sections. To choose an action, touch the appropriate button on the control panel. You can also touch different fields to enter information in that field. For example: the display in the following figure shows the list of endoscopes routinely processed in the system (your actual control panel display will be different depending on the data entered to create the list). To choose “Scope 2,” you would touch that button on the display. Touching this button enters the endoscope ID into the cycle history file. To add a new endoscope to the displayed list, you would touch the Add Endoscope button at the bottom of the display. Note:

Adding new endoscope information may be a password-protected feature. If a scope is highlighted, it has not been qualified for automated cleaning.

Move to Previous Page

Move to Next Page

Select This Endoscope For Processing

Add Endoscope to List from Database

Return to Previous Display Without Selecting an Endoscope

Figure 6. Sample endoscope display. Touch the button for the endoscope you wish to process. The highlighted scope should be manually cleaned, and leak/blockage tested prior to being reprocessed.

16

EVOTECH® ECR User’s Guide

Introduction

1

Control Panel Display Buttons The table below lists the primary control panel buttons and their functions. A number of these buttons appear on different displays, however their function is the same regardless of the display. Button

Function Cycle Setup – Appears . This button appears in the Start Cycle button location if the system has been configured for this function. Displays a screen allowing you to select a the cycle type. Start Cycle – Starts the selected cycle to process your endoscope. Cancel – Cancels the current action or the cycle. Usually returns you to a previous menu. When a cycle is canceled, the system requests confirmation of the cancellation. Done – Completes the action taken, such as typing a PIN. Enters the information if appropriate. Help – Opens the Help screen which directs you to perform certain actions or to call ASP for more information. Appears in conjunction with system message displays. Process an Endoscope – Enter endoscope information for the desired cycle. If the scope name is highlighted, it has not been qualified for automated cleaning. Add an Endoscope – Adds endoscope information to the database. Remove Scope – Removes endoscope information from the database. Select this Item – This button appears next to previously entered information such as a procedure, physician name, or endoscope information. Touch the green arrow to select the desired item. This button is also used to move to the next screen. User Admin– Opens the User Administration display allowing you to add or change user information. Usually requires a certain password level to access. Add User – Adds a new user to the list of users authorized to log in and operate the system. Allows you to set the PIN for the users. Remove User – Removes the user name and PIN from the list of authorized users.

EVOTECH® ECR User’s Guide

17

1

Introduction Button

Function Edit User – Allows you to edit existing user information including PIN. Select Physician Information – Opens the list of physicians who can be selected as part of cycle information. Add a Physician – Opens a display allowing you to add a physician identification. Remove a Physician – Opens a display allowing you to remove an existing physician identification. Select a Procedure – Opens a list of pre-defined procedures that can be associated with the endoscope being processed. Add a Procedure – Opens a display allowing you to add procedure identification to be associated with the endoscope being processed. Remove a Procedure – Opens a display allowing you to remove a procedure identification. Select Patient Information – Opens a display allowing you to type or scan patient identification. System Utilities – Opens the System Utilities display. Access can be limited to password-protected features. This function is only available when the system is idle. System Diagnostics – Opens the System Diagnostics display. Access can be limited to password-protected features. This function is available while the system is idle. log out – Allows you to log out of the system. Check/Replace Solutions – Allows you to check the level of the high-level disinfectant, detergent, and alcohol and replace them if necessary. If the system indicates that the solutions need to be replenished, touch this button to proceed through the replacement procedure. Replace Disinfectant – Allows you to enter disinfectant lot and expiration date and view the steps you perform to replace the high-level disinfectant container. Replace Detergent – Displays the steps you perform to replace the detergent container. Self-Disinfect – Transfers you to the Self-Disinfect start screen for both basins.

18

EVOTECH® ECR User’s Guide