ASP Sterrad Velocity Reader User Manual
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ASP Sterrad Velocity Reader User Manual

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User's Guide
AB11321031
AB11321031-50 January 2021.
© ASP 2021. All rights reserved.

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Summary of Contents for ASP Sterrad Velocity Reader

  • Page 1 Reader User’s Guide AB11321031 AB11321031-50 January 2021. © ASP 2021. All rights reserved.
  • Page 2 For warranty information, please visit our website or contact ASP Professional Services. © ASP 2021. All rights reserved. STERRAD VELOCITY™, ASP ACCESS™ and ALLClear™ are trademarks of Advanced Sterilization Products, Inc. (ASP). STERRAD™ and STERRAD NX™ are registered trademarks of Advanced Sterilization Products, Inc.

  • Page 3: Table Of Contents

    If You Have Questions ..................2 Chapter 2. Safety Information ..............3 Symbols ........................3 Warnings, Cautions, and Notes ................5 Chapter 3. Overview ...................9 The STERRAD VELOCITY Reader and Features ..........9 Before You Start ..................10 Start and Warm-up ..................10 The Status Screen ..................11 System Status Indicator ................12 Biological Indicators ...................12...
  • Page 4 Backlight Conservation ................41 Volume ......................41 Display Brightness ..................42 Alert Sounds ....................42 Barcode Scanner in Use ................42 Reader Settings ...................42 Printer Settings ...................42 Date and Time ....................43 Calibrate Insertion Sensor .................43 Network Settings ....................43 ASP ACCESS Configuration ................44 STERRAD VELOCITY Reader User’s Guide...
  • Page 5 Date and Time Setup ..................69 Administrator Setup ..................70 STERRAD Sterilizer Setup .................71 Reader Setup ......................71 Control Chemical Indicator Color Change Configuration Setup .....72 Printer Setup ......................72 Setup Complete ....................72 Appendix F. Software License Agreement ..........73 STERRAD VELOCITY Reader User’s Guide...
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  • Page 7: Chapter 1. Introduction

    “Administrator-level” access. Intended Use The STERRAD VELOCITY Reader is used to incubate and automatically read the STERRAD VELOCITY Biological Indicator / Process Challenge Device at 57°C (134.6°F) for a final fluorescent result within 15 minutes. The BI is a rapid biological indicator designed for frequent monitoring and periodic testing of STERRAD™...

  • Page 8: Indications For Use

    Introduction Indications for Use The STERRAD VELOCITY Reader, in conjunction with the STERRAD VELOCITY Biological Indicator / Process Challenge Device, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD™ Sterilization Systems: •...

  • Page 9: Chapter 2. Safety Information

    GTIN: 10705037048915 Your safety is important to Advanced Sterilization Products, Inc. (ASP). The following sections provide information on safely using the STERRAD VELOCITY Reader. You must read and understand the safety information before operating the reader. Always pay attention to the warnings, cautions, and notes throughout this User’s Guide.
  • Page 10 This Side Up. Indicates the orientation the package should remain in during shipping and storage. For indoor use only. Keep away from sunlight. Indicates a medical device that needs protection from light sources. STERRAD VELOCITY Reader User’s Guide...

  • Page 11: Warnings, Cautions, And Notes

    CAUTION! A situation potentially causing instrument damage or data loss. Notes appear in italics and highlight specific information about the proper use and maintenance of the reader. 9 Note: Specific information about proper use and maintenance. STERRAD VELOCITY Reader User’s Guide...
  • Page 12 The instrument needs to be protected from moisture. Do not immerse the instrument in liquid, or spill liquid onto or into the instrument housing. CAUTION! FOR INDOOR USE ONLY. The instrument is designed primarily for indoor use. STERRAD VELOCITY Reader User’s Guide...
  • Page 13 BI in a well. Ensure that the time is synchronized between the reader, the Sterilizer and the ASP ACCESS™ to prevent errors occurring during manual entry. Process the BI according to the directions provided in the BI IFU.
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  • Page 15: Chapter 3. Overview

    The built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy. Biological Biological Indicator Well Indicator Well Status Touch Indicator Screen Interface System Status Indicator Figure 1. The STERRAD VELOCITY Reader STERRAD VELOCITY Reader User’s Guide...

  • Page 16: Before You Start

    Power Adapter Adapter Figure 2. The STERRAD VELOCITY Reader (Back) The back panel of the reader has four connector ports. The RJ45 connector port supports a 10/100/1000 Base-T Ethernet connection. The two USB 2.0 ports in the center allow the user to attach a USB barcode scanner, a printer, or an external hard drive.

  • Page 17: The Status Screen

    A small circular dot above a well number indicates that a positive control BI is currently in the well. Figure 3. The Status Screen with Alert Message STERRAD VELOCITY Reader User’s Guide...

  • Page 18: System Status Indicator

    Once the sterilization cycle is complete the BI is placed in one of eight biological indicator wells, on the top of the reader, for incubation and reading. The BI wells detect the presence of the BI and begin the incubation and interrogation process. STERRAD VELOCITY Reader User’s Guide...

  • Page 19: Biological Indicator Wells

    Well Status Indicator Light Indicator State Meaning Well Open Solid White Adding BI to Well Solid Green Passed Result Solid Red Failed Result Table 2. Well Status Indicator STERRAD VELOCITY Reader User’s Guide...

  • Page 20: Sleep Mode

    A, C, G, and I. Simply remove the blanking plate and attach the prongs which fit the wall outlet at the install location and then connect the adapter to the wall and the back of the reader. STERRAD VELOCITY Reader User’s Guide...

  • Page 21: Chapter 4. Operation

    Operation Chapter 4. Operation Instructions for Use This chapter gives instructions on how to use the STERRAD VELOCITY Reader to test the STERRAD VELOCITY Biological Indicator / Process Challenge Device and obtain positive or negative results. Process Description Remove the test BI from the sterilization chamber, or select a positive control BI from the shelf carton.
  • Page 22 Slowly rotate the biological indicator back and forth until an audible beep is heard. After successfully scanning the BI, enter the operator’s name and touch Next. Figure 6. Scan the BI Barcode STERRAD VELOCITY Reader User’s Guide...
  • Page 23 Yellow and refer to the “Troubleshooting“ section of this guide (Chapter 8). Figure 7. Chemical Indicator Color Change 9 Note: Chemical indicator confirmation for a positive control BI can be changed in the Utilities Menu under Control Alerts. STERRAD VELOCITY Reader User’s Guide...
  • Page 24 BI has been placed in the well and will begin the countdown until the result is displayed. The dot above the well number indicates it is a positive control BI. Figure 9. Place BI in Well STERRAD VELOCITY Reader User’s Guide...

  • Page 25: Adding A Test Bi

    BI to the well. Scan the barcode on the BI cap label with the configured barcode scanner. The reader is also able to use a handheld barcode scanner attached to a USB port. Figure 10. Select a Well STERRAD VELOCITY Reader User’s Guide...
  • Page 26 “Troubleshooting” section of this guide (Chapter 8). Figure 12. CI Color Change for a Test BI 9 Note: If activating BI processed in the STERRAD 100S or without ASP ACCESS continue to “Manual Entry of Cycle Information” (Chapter 4). Otherwise skip “Manual Entry of Cycle Information”...

  • Page 27: Manual Entry Of Cycle Information

    Activate the Test BI Follow the on-screen instructions to activate the BI (see illustrations below). If using a STERRAD VELOCITY BI Activator (43250), follow the activation instructions supplied with the Activator. Touch Activated once complete. STERRAD VELOCITY Reader User’s Guide...

  • Page 28: In-Progress Summary

    Figure 15. Place BI in Well In-Progress Summary Touch any active well number during a test to open the In-Progress Summary and get detailed information about the test in-progress. STERRAD VELOCITY Reader User’s Guide...

  • Page 29: Interpretation Of Results

    BI. The CI shifts from red/pink (unprocessed) to yellow (processed) after exposure to the hydrogen peroxide sterilization cycle. A processed CI may be yellow or yellow with some red/orange/brown dots. Red / Pink: no Yellow: color color change change Figure 17. Chemical Indicator Color Change STERRAD VELOCITY Reader User’s Guide...

  • Page 30: Negative Test Result

    9 Note: If a positive result is observed: 1. Follow the current hospital or healthcare facility policies and procedures regarding quarantine, or retrieval, and reprocessing of potentially non-sterile instruments and notification of the clinician(s). 2. Repeat the test with a second BI. STERRAD VELOCITY Reader User’s Guide...
  • Page 31 Report the positive BI to ASP including the product lot number. iii. Have the sterilizer checked by ASP and do not use the sterilizer until the unit has been checked. The reader will ask for confirmation that the instructions have been viewed. Touch Yes or remove the BI to continue to the Result Confirmation.

  • Page 32: Positive Result On A Positive Control

    Instructions. Enter the operator’s name and follow the instructions for handling a negative result. Touch Next. 9 Note: If a negative result is observed repeat the test with a second BI from the same lot as the first negative result. STERRAD VELOCITY Reader User’s Guide...

  • Page 33: Second Negative Result On A Positive Control

    Touch Continue or remove the BI to silence the alarm and go to the next steps. Enter the operator’s name and follow the directions for handling a second negative result. Touch Done when finished. STERRAD VELOCITY Reader User’s Guide...

  • Page 34: Optional Visual Interpretation Of Results

    9 Note: If the second positive control BI result is negative: 1. Consult the “Troubleshooting” section (Chapter 8) of the User’s Guide. 2. Contact Advanced Sterilization Products, Inc. (ASP). The reader will ask for confirmation that the instructions are understood. Touch Yes or remove the BI to continue to Result Confirmation.
  • Page 35 Operation 9 Note: The STERRAD VELOCITY Reader can detect residual enzyme activity even when the G. stearothermophilus spores are damaged to the point they will not grow. Therefore, a BI may read as fluorescence-positive even when it is visually growth-negative. This characteristic of the enzyme response provides an increased...
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  • Page 37: Chapter 5. Files

    Files Chapter 5. Files The STERRAD VELOCITY Reader generates several different types of files for recordkeeping and diagnostic purposes. System Information Files The System Information file contains identification and performance information related to the specific reader which created it. The identification information includes the system name, serial number, model number, manufacturer, and date of manufacture.

  • Page 38: History Files

    Notes can be added when reviewing the Results Summary after the reading process is complete, or in the History utility while viewing the details of a specific result. Status Screen > Utilities > History > Select a Result > Add Note STERRAD VELOCITY Reader User’s Guide...

  • Page 39: Reader Log

    The Reader Log is a software diagnostic log file available to users with administrator access. It contains a log of software error codes which can be used to diagnose an issue with the reader. Status Screen > Utilities > Reader Log STERRAD VELOCITY Reader User’s Guide...
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  • Page 41: Chapter 6. Maintenance

    Care and Cleaning For questions about proper cleaning techniques or if interior cleaning or service is required, please contact ASP at 1-888-STERRAD. If cleaning is necessary, unplug and allow the reader to cool. Wipe the exterior surfaces of the reader using a cloth dampened with mild non-abrasive detergent. Do not spray cleaning products directly on the reader.

  • Page 42: Reader Disposal

    In the event that disposal of the reader is necessary, the device may be returned to ASP, recycled with a local recycler, or disposed of in a local landfill. Disposal of electronic circuit boards and coin cell batteries is regulated by the U.S. Environmental Protection Agency and most international environmental agencies.

  • Page 43: Chapter 7. Access Levels And Administrator Tasks

    • Add, delete, and modify administrator accounts. • Select, view, and print all reader files. • Run diagnostic tests and print reports. • Set date and time. • Edit System Configuration. STERRAD VELOCITY Reader User’s Guide...

  • Page 44: Utilities Menu

    Access Levels and Administrator Tasks • Configure the network connection and upload data to the network. Service-level access is only for use by ASP Service Representatives. Utilities Menu The Utilities Menu is available to all users, but only users with Administrator- level or Service-level access privileges can alter the settings.

  • Page 45: Manage Administrators

    The Manage Sterilizers utility allows administrators to add, remove, or edit the settings of a sterilizer. Adding or changing sterilizer information here changes the information which can be selected from the drop down menus in “Manual Entry of Cycle Information” (Chapter 4). STERRAD VELOCITY Reader User’s Guide...

  • Page 46: Add New Sterilizer

    Touch Done to return to the Utilities Menu. 9 Note: Edit and Delete functions are only allowed for sterilizers which were manually entered. Sterilizer information auto-populated by ASP ACCESS is not editable. Add New Sterilizer Touch Add New to add a new STERRAD Sterilizer. On the Add New screen enter the STERRAD ID, select the Model of the sterilizer, and select the Cycles used on that model.

  • Page 47: System Configuration

    Volume Volume allows the operator to adjust the internal speaker volume up or down. Touch the plus sign (+) to increase the alarm volume, and touch the minus sign (-) to decrease the alarm volume. STERRAD VELOCITY Reader User’s Guide...

  • Page 48: Display Brightness

    USB ports. Select the USB port with the desired printer from the drop down menu. Touch Test Print to print a test page. Touch Done to return to System Configuration. STERRAD VELOCITY Reader User’s Guide...

  • Page 49: Date And Time

    (i.e. the date, time, and time zone are set to the same value on the sterilizer, reader, and ASP ACCESS). Touch Done to return to the Utilities Menu. Under Set Date choose the current month, day, and, year from the drop down menus. Under Date Format use the drop down menu to choose how the date is displayed on the Status Screen.

  • Page 50: Asp Access Configuration

    ASP ACCESS Configuration fill in the ASP ACCESS Server, the IP Address, Username and the Pairing Code. Touch Test to verify that the reader is connected to the ASP ACCESS device. During the test the reader will display a busy screen with the words “One Moment…...

  • Page 51: File Management

    In the Utilities Menu touch File Management. Under STERRAD VELOCITY Reader select the file, or files, to be reviewed or copied. Touch Select All to select all of the files stored on the reader. Touch a specific file in the list and touch Get Info to see information about that specific file.
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  • Page 53: Chapter 8. Troubleshooting

    An incompatible Incompatible Use STERRAD VELOCITY biological indicator biological indicator Biological Indicators. has been scanned. A used in the reader. STERRAD VELOCITY Biological Indicator must be used in the STERRAD VELOCITY Reader. STERRAD VELOCITY Reader User’s Guide...
  • Page 54 Sensor” section (Chapter 7) for more information. Our records indicate that BI is from a canceled Use a BI from a completed this biological indicator is cycle. cycle. not from a completed cycle. It cannot be incubated. STERRAD VELOCITY Reader User’s Guide...
  • Page 55 Note: If the STERRAD VELOCITY been incubated. It cannot incubation cycle is canceled be incubated again. after proceeding past the BI activation screen, the reader will consider the BI as incubated and cannot incubate that BI again. STERRAD VELOCITY Reader User’s Guide...
  • Page 56 BI from the box and processing of the biological contact ASP. Ensure that BI is indicator. This may lead to stored per BI IFU. Use another an incorrect result.
  • Page 57 STERRAD Sterilizer Login as an administrator and is not available when has not been added add the STERRAD Sterilizer manually entering cycle to the system. under Manage Sterilizers. information. Utilities > Manage Sterilizers > Add New STERRAD VELOCITY Reader User’s Guide...
  • Page 58 BI activation. Agitate the BI to ensure the medium is free of large bubbles and flows into the growth reservoir. Second Positive Control Faulty BI, improper Stop using BIs from that lot BI returns negative result. storage. and contact ASP. STERRAD VELOCITY Reader User’s Guide...
  • Page 59 BI for cracked ampuole pior to processing. Do not process cracked BI. Contact ASP. Failure to scan BI barcode. Faint or smudged Verify the BI is an ASP validated barcode, material BI, remove anything which obscuring barcode might obscure the barcode and...
  • Page 60 BI contamination on sterilizer performance. negative result. BI, sterilization not achieved, improperly placed BI, ingress hole blocked. May be due to overloaded chamber, wet load, material incompatibility, BI misuse, or defective BI. STERRAD VELOCITY Reader User’s Guide...
  • Page 61 ASP including the product wet load, material lot number. incompatibility, Have the sterilizer checked BI misuse, or by ASP and do not use the defective BI. sterilizer until unit has been checked. BI ampoule breaks during Ampoule defect. Reprocess load with new BI.
  • Page 62 Wait 15 minutes after connecting to power to ensure completed boot up process. If problem persists, contact ASP. BI does not fit in Non-ASP BI. Only use STERRAD VELOCITY reader well. BIs in the reader. STERRAD VELOCITY Reader User’s Guide...
  • Page 63 BI is invalid, reprocess the causing the biological turning of BI while load with a new BI. indicator in well No. X to incubating. be void. Please remove the biological indicator. Table 3. User Error Messages STERRAD VELOCITY Reader User’s Guide...

  • Page 64: System Error Messages

    Contact ASP if you are presented with an error code. Any BI’s that were incubating at the time of the error are invalid and the load should be reprocessed with a new BI.

  • Page 65: Appendix A. Accessories And Additional Parts

    Appendix Appendix A. Accessories and Additional Parts STERRAD VELOCITY Reader Printer P/N 43221 STERRAD VELOCITY BI Activator P/N 43250 Handheld USB Barcode Scanner P/N 10308 60W AC Power Adapter — Input: 100V–240V AC at 50Hz–60Hz Output: 12V DC at 5A Max.
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  • Page 67: Appendix B. Reader Specifications

    A, C, G, and I Touchscreen Size 178 mm (7") Touchscreen Display Area 153.6 mm x 90 mm (6" x 3.5") Touchscreen Resolution 1024 x 500 Touchscreen Aspect Ratio 16:9 Weight 3.4 lbs. (1.5 kg) STERRAD VELOCITY Reader User’s Guide...
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  • Page 69: Appendix C. User's Network Connection Information

    “No Connection”. After returning to Network Settings verify that the network settings are correct and try the network connection test again. If the test fails a second time refer to the “Troubleshooting” section of this guide (Chapter 8). STERRAD VELOCITY Reader User’s Guide...
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  • Page 71: Appendix D. Compliance And Regulatory Standards

    Appendix Appendix D. Compliance and Regulatory Standards The STERRAD VELOCITY Reader complies with the following European directives, US regulation, and standards: Low Voltage Directive, 2014/35/EU RoHS (Restriction of Hazardous Substances) Directive, 2011/65/EU Electromagnetic Compatibility (EMC) Directive, 2014/30/EU Waste Electrical and Electronic Equipment (WEEE) Directive, 2012/19/EU...
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  • Page 73: Appendix E. First Time Setup

    Appendix Appendix E. First Time Setup When the STERRAD VELOCITY Reader is first powered on the user will receive a Welcome screen. Select the language from the list and touch Next. Figure 26. First Time Setup Welcome Network Setup Network setup should be performed by a trained ASP Representative. Touch Yes and Next if connecting through a network;...

  • Page 74: Asp Access Setup

    Enter the ASP ACCESS Server which can be found on the ASP ACCESS user interface. Once the IP address for the reader is entered in ASP ACCESS it will generate a Pairing Code. Enter the ASP ACCESS Username and Pairing Code and touch Test to verify the connection.

  • Page 75: Date And Time Setup

    Touch Back to go to the previous screen or touch Next to continue. Ensure that the time is synchronized with associated Sterilizers. Figure 29. Date and Time Setup STERRAD VELOCITY Reader User’s Guide...

  • Page 76: Administrator Setup

    1 lowercase, 1 upper case and 1 number. Touch Delete to remove the selected account. Touch Next to continue or touch Back to return to the previous screen. STERRAD VELOCITY Reader User’s Guide...

  • Page 77: Sterrad Sterilizer Setup

    STERRAD Sterilizer Setup STERRAD Sterilizer Setup adds sterilizers to the system. If the sterilizers are connected to the network touch No and Next and ASP ACCESS will provide this information. Otherwise; touch Yes and Next and Add a STERRAD Sterilizer to begin adding sterilizers.

  • Page 78: Control Chemical Indicator Color Change Configuration Setup

    Back to return to the previous screen. Setup Complete The setup is now complete. Touch Done for the system to begin the warm-up sequence. After the warm-up sequence the reader is ready for use. STERRAD VELOCITY Reader User’s Guide...

  • Page 79: Appendix F. Software License Agreement

    1 This includes STERRAD NX, STERRAD 100NX, STERRAD 100S, STERRAD™ 200 and all ASP products/accessories used with STERRAD systems that utilize, involve or interface with ASP Software including but not limited to ALLClear Technology, ASP ACCESS and ASP biological indicator readers.
  • Page 80 State of Delaware, without regard to its choice of law principles. ASP or you may elect to resolve any claim arising out of, or pursuant to, or relating to this Agreement, by individual arbitration. Claims are decided by a neutral arbitrator.
  • Page 81 ASP will be responsible for any additional arbitration fees. You may reject this Arbitration provision by sending a written rejection notice to ASP at the address stated at the end of this Agreement. You must mail your rejection notice within forty-five (45) days after the date of this Agreement.
  • Page 82 This License is automatically terminated if you either (i) breach any term of the License, or (ii) tamper with the hydrogen peroxide container/cassette or use sources of hydrogen peroxide other than Certified ASP Hydrogen Peroxide containers/cassettes in the Product. Further, your use of the Software in any non-compliant manner with the License may subject you to criminal and/or civil penalties for such breach.

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