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Steris SCOPE BUDDY PLUS Operator's Manual

Steris SCOPE BUDDY PLUS Operator's Manual

Endoscope flushing aid
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4008050
en
Revision B
SCOPE BUDDY™ PLUS
Endoscope Flushing
Aid
Operator Manual

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Summary of Contents for Steris SCOPE BUDDY PLUS

  • Page 1 SCOPE BUDDY™ PLUS Endoscope Flushing Operator Manual 4008050 Revision B...

  • Page 2: Copyright Information

    Copying, distribution, or use of this publication are prohibited without the express written consent of STERIS. STERIS reserves the right to amend the specifications described herein without any obligation for advance warning. For further information, contact your STERIS customer service representative.
  • Page 3 1 — A Word from STERIS NOTE: Equipment Damage Always follow the endoscope manufacturer’s instructions and established professional guidelines to properly perform the manual cleaning process for an endoscope • Precise manual cleaning of the endoscope and accessories must be performed using an appropriate detergent solution.

  • Page 4: Safety Precautions

    WARNING PERSONAL INJURY SCOPE BUDDY™ PLUS Endoscope Flushing Aid has been validated by STERIS with INTERCEPT™ Detergent, PROLYSTICA™ 2X Concentrate Enzymatic Presoak and Cleaner, PROLYSTICA™ HP Enzymatic Manual Cleaner, and Revital-OX™ Enzymatic Detergent. Information for these detergents is as follows: 4008050_B SCOPE BUDDY™...
  • Page 5 2 — Safety Precautions Table 2-1. Flushing Aid Settings Detergent Water Temperature Dilution % (minimum) Dilution % (maximum) 0.50% INTERCEPT™ Detergent 0.35%* 68 °F (20 °C) – 95 °F (35 °C) PROLYSTICA™ 2X 0.25%** 0.40% 90 °F (32 °C) – 113 °F (45 Concentrate Enzymatic °C) Presoak and Cleaner...
  • Page 6 The manual is intended to be used in conjunction with the instructions and labeling provided by the endoscope/accessory manufacturer and established professional guidelines for cleaning endoscopes. WARNING PATIENT SAFETY Use only with the 24-Hour Tubing made for SCOPE BUDDY PLUS Endoscope Flushing Aid. 4008050_B SCOPE BUDDY™ PLUS Endoscope Operator Manual...
  • Page 7 2 — Safety Precautions CAUTION EQUIPMENT DAMAGE Any of the listed compatible STERIS enzymatic detergents will require use of “warm” water as indicated in the previous table and thus the default values for Water Temperature Monitoring must be adjusted. CAUTION EQUIPMENT DAMAGE Do not use this device on NON-IMMERSIBLE endoscopes.

  • Page 8: Equipment Damage

    2 — Safety Precautions CAUTION EQUIPMENT DAMAGE Use of a different detergent or dilution does not guarantee the performance, durability or reliability of the device. CAUTION EQUIPMENT DAMAGE Users should be properly trained and instructed to inspect, prepare, use, clean, disinfect, rinse, dry, and store endoscopes.

  • Page 9: Symbols And Labels

    3 — Symbols and Labels Symbols and Labels 3.1 Nameplate The following symbols are found on the nameplate of the endoscope flushing aid: Name Symbol Standard Definition Catalogue number ISO 15223-1:2021, ref. Indicates the manufacturer’s catalogue 5.1.6 number so that the medical device can be identified.

  • Page 10: Specifications And Requirements

    4 — Specifications and Requirements Specifications and Requirements 4.1 Product Specifications Dimensions 7.5 in (19 cm) (W) x 11.5 in (29.2 cm) (D) x 10.3 in (26.2 cm) (H) Weight 10 lbs (4.5 kg) Power Supply Cord Connection Overvoltage Category Pollution Degree 4.2 Operational Specifications Electrical Rating...

  • Page 11: Component Identification

    5 — Component Identification Component Identification 5.1 Exterior Components Front View The following components are located on the exterior of the endoscope flushing aid and are visible from the front. See Figure 5-1. Figure 5-1. Front View 1. Touchscreen: The touchscreen is used to make selections and navigate menus. 2.
  • Page 12 5 — Component Identification Figure 5-2. Side View 1. Barcode reader USB port: The barcode reader USB port is used to connect the barcode scanner. 2. USB ports: The USB ports are used to connect USB devices. 3. Power cord inlet: The power cord inlet is used to connect the power cord. 4.

  • Page 13: Operator Controls

    5 — Component Identification Figure 5-3. Power Supply 5.2 Operator Controls Button Legend (When Using System Software) The following table is a button legend for the Scope Buddy™ Endoscope Flushing Aid. See Figure 5-4. Operator Manual SCOPE BUDDY™ PLUS Endoscope 4008050_B Flushing Aid...
  • Page 14 5 — Component Identification Home User or Patient Manual Mode Keypad Back Automatic Mode Backspace Endoscope Warning Settings Sink Quality Control Clean Container Flushing (QC) Test Detergent Process Dosing Complete Data Logs Process Failed Air Purge Scroll Up Play Aspiration Scroll Down Pause Run Continuous...
  • Page 15 5 — Component Identification 5.3 Accessories Reusable Temperature Probe The reusable temperature probe measures the water temperatures in the sink and a separate clean container. See Figure 5-5 Figure 5-6. Figure 5-5. Temperature Probe Inlet Location Figure 5-6. Temperature Probe Setup NOTE: When using the sink only pathway, both sensors should be placed in the sink.
  • Page 16 5 — Component Identification Barcode Scanner The barcode scanner is used to scan and record User, Endoscope, Patient ID and detergent lot numbers. The barcode scanner includes the left and right mounting brackets to attach it to the endoscope flushing aid. See Figure 5-7.
  • Page 17 5 — Component Identification noted. Reprocessing or steam sterilization of tubing will cause irreversible damage and void the warranty. Use beyond 24-hours may not provide adequate flushing and will void the warranty. Pump Tube (Optional) The pump tube doses detergent to the sink and pulls water from the sink or clean container, through the pump, out of the luer connector and into a 24-hour hookup tubing for endoscopes.
  • Page 18 5 — Component Identification 24-Hour Hookup Tubing for Endoscopes (Optional) 24-hour hookup tubing for endoscopes connect the pump tube to the endoscope channels. 24-hour hookup tubing for endoscopes are interchangeable during the 24-hour period. Always ensure the 24-hour hookup tubing for endoscopes used corresponds to the correct endoscope manufacturer.
  • Page 19 5 — Component Identification 24-Hour Tubing for FUJIFILM™ Endoscopes (Optional) This tubing allows for connection to most FUJIFILM™ Endoscopes. See Figure 5-13. Figure 5-13. FUJIFILM™ Tubing 24-Hour Tubing for FUJIFILM™ 700 Endoscopes (Optional) This tubing allows for connection to FUJIFILM™ 700 endoscopes. See Figure 5-14.
  • Page 20 5 — Component Identification Figure 5-15. 24–Hour Tubing for Universal Hookup NOTE: The Aspiration step using the SCOPE BUDDY™ PLUS Endoscope Flushing Aid cannot be performed using the 24-hour tubing for universal hookup with any suction port cleaning adapter containing a backflow valve. Figure 5-16.
  • Page 21 5 — Component Identification Figure 5-17. Wire-Guided Dilators NOTE: For Wire-Guided Dilators: The 24-hour tubing for universal hookup can also be used to flush one to four wire-guided dilators at a time. If flushing less than four wire-guided dilators, ensure the dilators are connected to connectors 2, 3, and/or 4.
  • Page 22 5 — Component Identification Figure 5-19. Air/Water Blanking Cap 5.4 Consumables Detergent The following is a list of approved detergents, dilution percentages, and water temperature ranges for the SCOPE BUDDY™ PLUS Endoscope Flushing Aid. CAUTION EQUIPMENT DAMAGE Use of a different detergent or dilution does not guarantee the performance, durability or reliability of the device.
  • Page 23 5 — Component Identification NOTE: * The default dilution of 0.35% for INTERCEPT™ Detergent is intended to incorporate an added 0.10% margin above the minimum of 0.25% listed on the label for INTERCEPT™ Detergent, in order to account for accuracy variation in detergent dose volume and/or water fill volume in the sink or clean container.

  • Page 24: Installation Instructions

    6 — Installation Instructions Installation Instructions 6.1 Connection Instructions Connect the power cord to the power cord inlet and to an AC outlet. The power supply can be connected to a power source of 100 VAC to 240 VAC 50/60 Hz. Ensure the rotating locking collar on the power supply is secured to the threaded power cord inlet.
  • Page 25 6 — Installation Instructions Figure 6-1. Barcode Scanner Side View 1. Left-Sided Mounting a. Assemble the barcode scanner bracket to the back left side of the device using the 4 provided Phillips screws as shown below (1 and 2). See Figure 6-2.
  • Page 26 6 — Installation Instructions Figure 6-3. Left Side Rear View 2. Right-Sided Mounting a. Assemble the barcode scanner bracket to the back right side of the device using the 4 provided Phillips screws as shown below (1 and 2). See Figure 6-4.
  • Page 27 6 — Installation Instructions Figure 6-5. Right Side Rear View 3. Insert the USB cable into barcode reader USB port. See Figure 6-6. Figure 6-6. Barcode Reader USB Port 4. To scan a barcode, point the barcode scanner output at the barcode and depress the yellow trigger. WARNING PERSONAL INJURY Do not point the barcode scanner at your face or that of any other people.

  • Page 28: First Time Setup

    This approach avoids the need to change the flushing volume each time a different model of endoscope is flushed. STERIS has conducted extensive flow studies to validate flushing times for endoscopes determined to have worst case flushing times, including colonoscopes, duodenoscopes, EUS scopes, and bronchoscopes.
  • Page 29 6 — Installation Instructions Figure 6-8. Set Date 5. Set the desired time and time format. See Figure 6-9. Figure 6-9. Set Time 6. Set the desired volume and temperature units. See Figure 6-10. Figure 6-10. Set Volume and Temperature Units Operator Manual SCOPE BUDDY™...
  • Page 30 6 — Installation Instructions 7. Set the default detergent source to either ‘Sink’ or ‘Clean Container’. Pathways There are two fluid pathways: Sink or Clean Container. The endoscope flushing aid can be used in either configuration depending on the facility’s endoscope cleaning procedure. See Figure 6-11.
  • Page 31 6 — Installation Instructions Figure 6-13. Enter Sink Volume 10. Load a new detergent container. a. Scan the detergent lot number using the barcode scanner or press the keypad icon in the bottom right corner of the screen to enter the lot number manually. See Figure 6-14.
  • Page 32 6 — Installation Instructions Figure 6-15. Set Detergent Dilution Detergent Dilution % INTERCEPT™ Detergent 0.35% 0.25% PROLYSTICA™ 2X Concentrate Enzymatic Presoak and Cleaner PROLYSTICA™ HP Enzymatic 0.25% Manual Cleaner 0.25% Revital-Ox™ Enzymatic Detergents NOTE: Refer to detergent IFU for correct percentage. Concentrations of 0.25-1.00% may be entered, but should be limited to a maximum of 0.40% for PROLYSTICA™...
  • Page 33 6 — Installation Instructions Figure 6-16. Configure Cycle Sequence 14. Press ‘OK’ to confirm first time setup is complete and proceed to automatic mode. If first time setup was accessed through the ‘settings’ menu, the screen will return to the ‘settings’ menu. See Figure 6-17.
  • Page 34 6 — Installation Instructions • Users are prompted to enter User ID, Endoscope ID, and Patient ID (optional) at the start of each cycle. • The endoscope flushing aid will automatically dose detergent in accordance with the volume and dilution percentage of the sink and/or clean containers selected in first time setup.

  • Page 35: Device Settings

    6 — Installation Instructions 3. Scan User ID or use keypad, and enter any number for Endoscope ID and Patient ID (if activated). 4. Select dosing. 5. Press sink icon. 6. Press the keypad icon. 7. Press the backspace icon to clear the field and then use the number pad to enter 20 ml. Press OK. 8.
  • Page 36 6 — Installation Instructions Loading New Detergent 1. Select ‘load new detergent.’ 2. Scan detergent barcode or use keypad to enter lot number. 3. Thread the cap of detergent intake tube on container and ensure the tube reaches the bottom of detergent container.
  • Page 37 6 — Installation Instructions PROLYSTICA™ 2X Concentrate Enzymatic Presoak and 0.25% Cleaner 0.25% PROLYSTICA™ HP Enzymatic Manual Cleaner Revital-Ox™ Enzymatic Detergents 0.25% 3. Press ‘OK’ when desired dilution is displayed. Changing Detergent Type When changing the detergent used in the device from one type to another, the detergent lines must be purged using the following procedure: 1.
  • Page 38 6 — Installation Instructions Figure 6-22. Data Logs Menu 2. Use the up and down arrows to select the desired log. 3. Each data log will display the following: ID number, date, time, cycle start and finish, Endoscope ID, User ID, Patient ID, dosing volume and duration, auxiliary dosing volume and duration, brushing, aspiration, flushing, and air purge duration.
  • Page 39 The screen will return to the ‘select export destination’ screen when the export reaches 100%. If the export is unsuccessful, repeat export logs procedure. Contact STERIS if problems persist. After a successful export, power off the endoscope flushing aid using the power button. After the endoscope flushing aid is powered down and green LED light turns off, remove USB device from machine.
  • Page 40 6 — Installation Instructions Figure 6-25. Temperature Range Use the chart below to determine the correct water temperature range to enter: Detergent Water Temperature Range INTERCEPT™ Detergent 68 °F (20 °C) — 95 °F (35 °C) PROLYSTICA™ 2X Concentrate Enzymatic Presoak and 90 °F (32 °C) —...
  • Page 41 13. Document results on SCOPE BUDDY™ PLUS Endoscope Flushing Aid dosing verification and calibration log. NOTE: Do not empty the graduated cylinder after the first step, dosing calibration is not complete. Expert Menu The expert menu is password protected and should only be entered by a STERIS technician. Operator Manual SCOPE BUDDY™ PLUS Endoscope...
  • Page 42 6-29. Figure 6-29. QC Test 8. A green check mark will appear if the volume is adequate and the test passed. A red X will appear if the volume is inadequate and the user should contact STERIS. See Figure 6-30.
  • Page 43 6 — Installation Instructions Figure 6-30. QC Test Pass/Fail Configure Cycle Sequence The configure cycle sequence section allows the user to activate or inactivate the following cycle options: brushing step, aspiration step, Patient ID scan, and temperature monitoring. See Figure 6-31.
  • Page 44 6 — Installation Instructions 2. Press ‘OK’ to proceed. Temperature Units The temperature units section allows the user to adjust the default temperature units. See Figure 6-32. Figure 6-32. Temperature Units 1. To select either Fahrenheit or Celsius, press the option button corresponding to the desired unit. 2.
  • Page 45 6 — Installation Instructions Figure 6-34. Set Date Figure 6-35. Set Time 1. Choose the desired date or time format by selecting the appropriate option button. 2. Change the current date by pressing the up and down arrows corresponding to month (M), day (D) and year (Y). 3.
  • Page 46 6 — Installation Instructions Figure 6-36. Language 1. Select the desired language by pressing the appropriate row. About The about section allows the user to view the endoscope flushing aid’s Operating System (OS) Version, Software Version, Serial Number, and Technical Support phone number. To return to the settings menu, press the back arrow.
  • Page 47 6 — Installation Instructions Software Installation To install the software, insert the USB drive into a PC and follow the prompts for installation. Once installation is complete, click Finish to exit Setup. See Figure 6-38. Figure 6-38. Dashboard Installation Desktop Shortcuts Once installed, the SCOPE BUDDY™...
  • Page 48 1. Double-click the ‘SCOPE BUDDY™ PLUS Exports’ folder shortcut on the desktop. A folder window will open in File Explorer. See Figure 6-40. Figure 6-40. Scope Buddy Plus Exports 2. Copy all 5 exported data logs (.txt) from a USB drive to this folder in File Explorer. NOTE: Export Logs for details on how to export data logs for use with the dashboard.
  • Page 49 6 — Installation Instructions Figure 6-42. Refresh All NOTE: Depending on the size of the exported data logs, this step may take several minutes. 6. Save the results of the dashboard report to a new Excel spreadsheet file. Reports This section explains how to analyze and interpret the reports displayed in the six sheets in the SCOPE BUDDY™ PLUS Dashboard.
  • Page 50 6 — Installation Instructions Figure 6-44. Dashboard The last column of the Dashboard sheet indicates whether any warnings occurred during the cycle. If one or more warnings occurred, see the warnings tab for details. See Figure 6-45. Figure 6-45. Warnings Occurred In manual mode flushing is used for both the flushing and rinsing steps and air purge is used for both air purges after flushing and rinsing.
  • Page 51 6 — Installation Instructions Figure 6-48. Filter By Endoscope ID The Chart sheet displays a detailed report of the average number of cycles per week for the last 13 weeks for the SCOPE BUDDY™ PLUS Endoscope Flushing Aid. See Figure 6-49.
  • Page 52 6 — Installation Instructions Figure 6-51. Detergent Scans The QC Tests sheet displays a detailed log of all QC tests by Time Started and Finished, Duration and Output Volume (in ml). See Figure 6-52. Figure 6-52. QC Tests The Setting Changes sheet displays a detailed log of all setting changes by Time, User ID and Description. See Figure 6- Figure 6-53.

  • Page 53: Operating Setup

    7 — Operating Instructions Operating Instructions 7.1 Operating Setup This section reviews the two different modes and pathways that can be configured for your facility and practice. Run Modes SCOPE BUDDY™ PLUS Endoscope Flushing Aid has two modes: Automatic and Manual. See Figure 7-1.
  • Page 54 7 — Operating Instructions Pathways There are two fluid pathways: sink only or clean container. The endoscope flushing aid can be used in either configuration depending on the facility’s endoscope cleaning procedure. Sink Only Pathway • Detergent is dosed out of the front detergent out port into the sink only. Choose this option to dose detergent only to the sink.
  • Page 55 7 — Operating Instructions Figure 7-3. Clean Container Pathway NOTE: These illustrations are a representation of an OLYMPUS® Endoscope using the 24-hour tubing for OLYMPUS® Endoscopes and pump tube. Screensaver After prolonged user inactivity, the device will display a moving image screensaver. Dismiss screensaver by touching screen.
  • Page 56 7 — Operating Instructions Figure 7-4. User ID 2. Repeat step 1 for Endoscope ID and Patient ID (optional). See Figure 7-5. Figure 7-5. Endoscope ID and Patient ID Dosing During the Dosing step, detergent will dispense from the detergent out port through the pump tube and into the sink. NOTE: Do not connect endoscope until dosing is complete.
  • Page 57 7 — Operating Instructions Figure 7-6. Pump Tube Installation a. Connect luer lock fitting of pump tube to detergent out port on the front of the device. • Rotate lock fitting clockwise to tighten and counterclockwise to loosen. b. Rotate pump head lever to the left to open pump head. c.
  • Page 58 7 — Operating Instructions Figure 7-7. Detergent Intake Tube Installation a. Thread the cap on the detergent container. NOTE: Use a new detergent intake tube each time when loading new detergent. b. Adjust end of detergent intake tube to ensure tube reaches the bottom of detergent container. c.
  • Page 59 7 — Operating Instructions Figure 7-8. Automatic Mode Sink Only Dosing a. Fill sink with volume of water previously selected in first time setup. b. Install the temperature probe by aligning the notch on the connector and pushing the connector into the inlet until a click is felt.
  • Page 60 7 — Operating Instructions Figure 7-9. Brushing 1. Brushing Endoscope a. Use the up and down arrows to select the desired brush time. b. Press ‘PLAY’ to begin the brushing timer. c. Brush endoscope channels until no debris is observed, in accordance with the endoscope manufacturer’s IFU.
  • Page 61 7 — Operating Instructions Figure 7-10. Sink Only Aspiration Setup 1. Connect endoscope for aspiration. a. Place endoscope in sink. b. When using 24-hour tubing for OLYMPUS® Endoscopes, attach it to the endoscope and close all pinch clips. • When using DSD hookups, ONLY attach the suction connector to the endoscope. c.
  • Page 62 7 — Operating Instructions Figure 7-11. Aspiration Menu a. Select the desired aspiration time by using the up and down arrows. b. Press ‘PLAY’ to begin aspirating. NOTE: Aspiration times should be followed in accordance with OLYMPUS® manufacturer’s IFU. The timer can be increased or decreased at any time by pressing ‘PAUSE’ and using the up and down arrows. 3.
  • Page 63 7 — Operating Instructions Flushing The flushing step draws fluid through the strainer into the endoscope channels. Flushing in automatic mode is used to flush detergent solution through the endoscope as recommended per the manual cleaning guidelines of the endoscope manufacturer.
  • Page 64 7 — Operating Instructions Figure 7-14. First Air Purge 1. Prepare for first Air Purge. a. Drain sink. b. Lift strainer out of fluid c. Select the desired air purge time using the up and down arrows. d. Press ‘PLAY’ to begin air purge step. NOTE: If additional air purge time is needed, select ‘BACK’...
  • Page 65 7 — Operating Instructions Figure 7-15. Sink Only Rinsing 1. Prepare for Rinsing. a. Refill the sink with fresh water. b. Place the strainer into the water. c. Select the desired rinsing time by using the up and down arrows. d.
  • Page 66 7 — Operating Instructions Figure 7-16. Second Air Purge 1. Prepare for second Air Purge. a. Drain sink. b. Lift strainer out of fluid. c. Select the desired air purge time using the up and down arrows. d. Press ‘PLAY’ to begin air purge. e.
  • Page 67 7 — Operating Instructions Figure 7-17. User ID 2. Repeat step 1 for Endoscope ID and Patient ID (optional). See Figure 7-18. Figure 7-18. Endoscope ID and Patient ID Dosing During the dosing step detergent will dispense from both the detergent out port through the pump tube and into the sink, and out of the auxiliary detergent out port into the clean container.
  • Page 68 7 — Operating Instructions Figure 7-19. Pump Tube Installation a. Connect luer lock fitting of pump tube to detergent out port on the front of the device. • Rotate lock fitting clockwise to tighten and counterclockwise to loosen. b. Rotate pump head lever to the left to open pump head. c.
  • Page 69 7 — Operating Instructions Figure 7-20. Detergent Intake Tube Installation a. Thread the cap on the detergent container. b. Adjust end of detergent intake tube to ensure tube reaches the bottom of detergent container. c. Connect detergent intake tube fitting to the detergent in port on the side of the device. d.
  • Page 70 7 — Operating Instructions Figure 7-21. Automatic Mode Clean Container Dosing a. Fill sink with volume of water previously selected in first time setup. b. Install the temperature probe by aligning the notch on the connector and pushing the connector onto the plug until a click is felt.
  • Page 71 7 — Operating Instructions Figure 7-22. Brushing 1. Brush endoscope. a. Using the up and down arrows select the desired brush time. b. Press ‘PLAY’ to begin the brushing timer. c. Brush endoscope channels until no debris is observed, in accordance with the endoscope manufacturer’s IFU.
  • Page 72 7 — Operating Instructions Figure 7-23. Clean Container Aspiration 1. Connect endoscope for aspiration. a. Place endoscope in sink. b. When using 24-Hour Tubing for OLYMPUS® Endoscopes, attach to endoscope and close all pinch clips. • When using DSD Hookups, ONLY attach the suction connector to the endoscope. c.
  • Page 73 7 — Operating Instructions Figure 7-24. Aspiration Menu a. Select the desired aspiration time by using the up and down arrows. b. Press ‘PLAY’ to begin aspirating. NOTE: Aspiration times should be followed in accordance with OLYMPUS® manufacturer’s IFU. The timer can be increased or decreased at any time by pressing ‘PAUSE’ and using the up and down arrows. 3.
  • Page 74 7 — Operating Instructions Flushing The flushing step draws fluid from the strainer into the endoscope channels. Flushing in automatic mode is used to flush detergent solution through the endoscope as recommended per the manual cleaning guidelines of the endoscope manufacturer.
  • Page 75 7 — Operating Instructions Figure 7-27. First Air Purge 1. Prepare for first Air Purge. a. Drain sink. b. Lift strainer out of fluid. c. Select the desired air purge time using the up and down arrows. d. Press ‘PLAY’ to begin air purge. NOTE: If additional air purge time is needed, select ‘BACK’...
  • Page 76 7 — Operating Instructions Figure 7-28. Clean Container Rinsing 1. Prepare for Rinsing. a. Refill the sink with fresh water. b. Fill at least 2-liter clean container with fresh water. c. Place the strainer into the clean container. d. Select the desired rinsing time by using the up and down arrows. e.
  • Page 77 7 — Operating Instructions Figure 7-29. Second Air Purge 1. Prepare for second Air Purge. a. Drain sink. b. Lift strainer out of fluid. c. Select the desired air purge time using the up and down arrows. d. Press ‘PLAY’ to begin air purge. e.
  • Page 78 7 — Operating Instructions Figure 7-30. User ID 2. Repeat Step 1 for Endoscope ID information and Patient ID information (optional). See Figure 7-31. Figure 7-31. Endoscope ID and Patient ID Dosing During the dosing step detergent will dispense from the detergent out port through the pump tube and into the sink. Press home to start a new endoscope.
  • Page 79 7 — Operating Instructions Figure 7-32. Manual Mode Menu 2. Install Pump Tube. See Figure 7-33. Figure 7-33. Pump Tube Installation a. Connect luer lock fitting of pump tube to detergent out port on the front of the device. • Rotate lock fitting clockwise to tighten and counterclockwise to loosen. b.
  • Page 80 7 — Operating Instructions Figure 7-34. Detergent Intake Tube Installation a. Thread the cap on the detergent container. b. Adjust end of detergent intake tube to ensure tube reaches the bottom of detergent container. c. Connect detergent intake tube fitting to the detergent in port on the side of the device. d.
  • Page 81 Revital-Ox™ Enzymatic Detergents 0.25% For use outside of the U.S.A., contact STERIS for more information. A warning will appear when water temperature is out of range. See for temperature sensor placement. Dosing can be paused and resumed at any time by pressing ‘PAUSE’.
  • Page 82 7 — Operating Instructions Figure 7-36. Sink Only Aspiration 1. Select Aspiration in Manual Mode. 2. Connect endoscope for aspiration. a. Place endoscope in sink. b. When using 24-hour tubing for OLYMPUS® Endoscopes, attach it to endoscope and close all pinch clips. •...
  • Page 83 7 — Operating Instructions Figure 7-37. Aspiration Menu a. Select the desired aspiration time by using the up and down arrows or by selecting ‘Run Continuous’ . b. Press ‘PLAY’ to begin aspirating. NOTE: Aspiration times should be followed in accordance with OLYMPUS® manufacturer’s IFU. The timer can be increased or decreased at any time by pressing ‘PAUSE’...
  • Page 84 7 — Operating Instructions • When using the DSD hookup, attach hookup to endoscope and biopsy cap over endoscope’s biopsy/instrument opening, referring to the IFU as needed. Flushing The flushing step draws fluid from the strainer into the endoscope channels. Flushing in manual mode is used to flush detergent solution or rinse water through the endoscope as recommended per the manual cleaning guidelines of the endoscope manufacturer.
  • Page 85 7 — Operating Instructions Air Purge The air purge step runs the pump to circulate air through the endoscope. See Figure 7-40. Figure 7-40. Air Purge 1. Select Air Purge in Manual Mode. a. Drain sink. b. Lift strainer out of fluid. c.
  • Page 86 7 — Operating Instructions Figure 7-41. User ID 2. Repeat step 1 for Endoscope ID and Patient ID (optional). See Figure 7-42. Figure 7-42. Endoscope ID and Patient ID Dosing During the dosing step detergent will dispense from both the detergent out port through the pump tube and into the sink, and out of the auxiliary detergent out port into the clean container.
  • Page 87 7 — Operating Instructions Figure 7-43. Manual Mode Menu 2. Install Pump Tube. See Figure 7-44. Figure 7-44. Pump Tube Installation a. Connect luer lock fitting of pump tube to detergent out port on the front of the device. • Rotate lock fitting clockwise to tighten and counterclockwise to loosen. b.
  • Page 88 7 — Operating Instructions Figure 7-45. Detergent Intake Tube Installation a. Thread the cap on the detergent container. b. Adjust end of detergent intake tube to ensure tube reaches the bottom of detergent container. c. Connect detergent intake tube fitting to the detergent in port on the side of the device. d.
  • Page 89 7 — Operating Instructions Figure 7-46. Manual Mode Clean Container Dosing a. Ensure sink icon is selected. b. Fill sink with water to correct volume for desired concentration. c. Install the temperature probe by aligning the notch on the connector and pushing the connector onto the plug until a click is felt.
  • Page 90 0.25% 0.25% Revital-Ox™ Enzymatic Detergents For use outside of the U.S.A., contact STERIS for more information. A warning will appear when water temperature is out of range. See for temperature sensor placement. Dosing can be paused and resumed at any time by pressing ‘PAUSE’.
  • Page 91 7 — Operating Instructions d. Attach pump tube to either 24-hour tubing for OLYMPUS® Endoscopes or 24-hour tubing adapter for DSD hookup. NOTE: For connection instructions, refer to the IFU provided in the carton for the 24-hour tubing for olympus® endoscopes or the 24-hour tubing adapter for DSD hookup.
  • Page 92 7 — Operating Instructions Figure 7-49. Clean Container Aspiration Completion a. Replace the strainer on the Pump Tube when aspiration is complete. b. Replace the biopsy cap on the endoscope biopsy port. c. When using the 24-hour tubing for OLYMPUS® Endoscopes, release the pinch clips on the tubing attached to the endoscope.
  • Page 93 7 — Operating Instructions 1. Select Flushing in Manual Mode. 2. Connect endoscope for flushing. a. Attach 24-hour hookup tubing for endoscopes or DSD hookup to endoscope. b. On 24-hour hookup tubing for endoscopes not connected to an endoscope port, close pinch clips. When using DSD hookups, every tubing branch should be connected to an endoscope port.
  • Page 94 7 — Operating Instructions c. Select the desired air purge time using the up and down arrows or by selecting ‘Run Continuous’ . d. Press ‘PLAY’ to begin air purge. NOTE: If additional air purge time is needed, select ‘BACK’ to repeat the step. The timer can be increased or decreased by pressing ‘PAUSE’...

  • Page 95: Routine Maintenance

    • Perform dosing verification. If dosing verification fails, perform dosing calibration and repeat dosing verification. Dosing Verification STERIS recommends the dosing system be verified daily to be within specification. If dosing verification fails, perform dosing calibration and repeat dosing verification to ensure dosing is calibrated. See Figure 8-1.
  • Page 96 8 — Routine Maintenance 4. Enter manual mode from home screen. 5. Select dosing. 6. Ensure sink Icon is selected. 7. Ensure 20 ml is displayed on the screen. If not, press the keypad icon and then press the backspace key to remove current value.

  • Page 97: Troubleshooting Guide

    5. Close pump head by turning lever to the right. If the problem persists, discard according to local regulations and replace pump tube. Contact STERIS if problem persists after replacing pump tube. External pump is running, but fluid is not exiting the 1.
  • Page 98 9 — Troubleshooting Touch screen needs re-calibration. Contact STERIS. Contact STERIS. Unit does not power off when power button is held down for 1 second. 9.2 Warnings Warning messages during the use of the endoscope flushing aid indicate an event which may compromise the ability of the user to perform the manual cleaning process properly according to the endoscope manufacturer cleaning instructions.
  • Page 99 Temperature Sensor Malfunction The Temperature Sensor malfunction warning alerts the user of a faulty temperature sensor. Either press ‘OK’ to disable temperature monitoring or replace temperature probe and press ‘Refresh’ to re-check sensors. If error persists, contact STERIS. See Figure 9-3.
  • Page 100 Output Restricted Attention The Output restricted attention screen occurs when the machine detects restricted flow but not a complete blockage. The machine will decrease the pump speed and display this screen. Contact STERIS if the error persists. See Figure 9-6.
  • Page 101 The Encoder Board Error warning screen occurs when the system has detected an erroneous Encoder Board reading. Power the unit down using the power button and power it back up. If the problem persists contact STERIS or your distributor. See Figure 9-7.
  • Page 102 Pressure Sensor Offset The Pressure Sensor Offset warning screen occurs when the machine is idle and the Pressure Sensor is indicating a pressure greater than 1.8 psi or less than -3.0 psi. Contact STERIS if the error persists. See Figure 9-10.
  • Page 103 9 — Troubleshooting Figure 9-10. Pressure Sensor Offset Operator Manual SCOPE BUDDY™ PLUS Endoscope 4008050_B Flushing Aid...
  • Page 104 10 — Appendix Appendix 10.1 Aspirating OLYMPUS® EUS Endoscopes Prior to commencing the aspiration procedure, all point-of-use treatment and manual cleaning steps, up to and including brushing, should be completed per manufacturer’s Instructions for Use (IFU). The directions below are to be used in conjunction with the instructions and labeling provided by the endoscope manufacturer and established professional guidelines for cleaning endoscopes.
  • Page 105 10 — Appendix Figure 10-2. Setting Up an OLYMPUS® EUS Endoscope for Aspiration 2. Place the endoscope in a sink with detergent solution. NOTE: For Linear EUS endoscopes, ensure the instrument channel cleaning adapter (MAJ-350) is attached. 3. Attach 24-Hour Tubing for OLYMPUS® Endoscopes to the pump tube. 4.
  • Page 106 10 — Appendix 10.2 Aspirating Dual Channel OLYMPUS® Endoscopes Prior to commencing the aspiration procedure, all point-of-use treatment and manual cleaning steps, up to and including brushing, should be completed per manufacturer’s Instructions for Use (IFU). The directions below are to be used in conjunction with the instructions and labeling provided by the endoscope manufacturer and established professional guidelines for cleaning endoscopes.

  • Page 107: Limited Warranty

    10 — Appendix Figure 10-3. Installation of OLYMPUS MAJ-420 Over Endoscope’s Biopsy Ports 10.3 Limited Warranty Subject to the terms below, Medivators Inc. (the “Company”) warrants that its products (the “Products”) will conform to the Company’s written specifications (where applicable) and will be free from defects in material and workmanship under normal use and service for the following periods (the “Warranty Period”): Endoscope reprocessors and associated equipment, and irrigation pumps: fifteen months from date of shipment from the Company or 1 year from the date of installation, whichever occurs first.
  • Page 108 10 — Appendix WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND THE COMPANY DOES NOT REPRESENT OR WARRANT THAT ANY PRODUCT WILL MEET CUSTOMER’S REQUIREMENTS. THE COMPANY’S RESPONSIBILITY FOR DEFECTS IN A PRODUCT IS LIMITED SOLELY TO REPAIR, REPLACEMENT OR REFUND OF THE PURCHASE PRICE AS SET FORTH IN THIS WARRANTY STATEMENT.

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