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Appendix

STERRAD VELOCITY Reader User’s Guide

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.

Advanced Sterilization Products, Inc. (“ASP”)

33 Technology Drive
Irvine, California 92618
1-888-STERRAD (1-888783-7723)
+ 1-949-581-5799 (internationally)

Содержание Sterrad Velocity Reader

Страница 2: ...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 ASP Other products me...

Страница 3: ...10 Start and Warm up 10 The Status Screen 11 System Status Indicator 12 Biological Indicators 12 Biological Indicator Wells 13 Sleep Mode 14 Touch Screen 14 Barcode Scanner 14 Power Adapter 14 Chapte...

Страница 4: ...7 Access Levels and Administrator Tasks 37 Access Levels 37 Utilities Menu 38 Admin Login 38 Manage Administrators 39 Add New Account 39 Edit or Delete Existing Account 39 Manage Sterilizers 39 Add Ne...

Страница 5: ...s and Additional Parts 59 Appendix B Reader Specifications 61 Appendix C User s Network Connection Information 63 Appendix D Compliance and Regulatory Standards 65 Appendix E First Time Setup 67 Netwo...

Страница 6: ...vi STERRAD VELOCITY Reader User s Guide THIS PAGE INTENTIONALLY LEFT BLANK...

Страница 7: ...Safety Information explains personal safety as well as device safety information Operation explains how to operate the reader and obtain optimal results Maintenance explains how to clean and care for...

Страница 8: ...rganism The reader incubates the BI at 57 C 134 6 F and provides final fluorescent results within 15 minutes The presence or absence of the viable indicator organism indicated by fluorescence in the B...

Страница 9: ...out this User s Guide This information is for your safety and to ensure that you receive the most benefit from the safe operation of your reader Symbols Emits laser radiation Avoid direct eye exposure...

Страница 10: ...ce manufacturer Date of Manufacture Indicates the date when the medical device was manufactured Hot Surfaces ASP The Netherlands BV BIC 1 5657 BX Eindhoven The Netherlands Authorized representative in...

Страница 11: ...printed in boldface text Warnings indicate events or conditions that can result in serious injury or death Cautions indicate events or conditions that can result in damage to the reader or data loss I...

Страница 12: ...or gloved hand or insert any non BI item in the instrument wells WARNING AVOID EXPOSURE TO ULTRAVIOLET LIGHT The fluorescence detection system uses an ultraviolet light source located inside the read...

Страница 13: ...ASP ACCESS to prevent errors occurring during manual entry Process the BI according to the directions provided in the BI IFU Do not process a BI from a canceled or aborted sterilization cycle The accu...

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Страница 15: ...or Process Challenge Device test wells which can be used for test samples or positive controls The thermoplastic exterior makes the instrument easy to clean and maintain The built in barcode scanner c...

Страница 16: ...r sets of interchangeable prongs which fit plug types A C G and I Attach the set of prongs which fit the plug socket to the AC power adapter Place the reader on a non vibrating level surface which is...

Страница 17: ...indicate success After a BI is added to a well and the reading process has begun a series of small tick marks will appear around the well number The small tick marks indicate the elapsed time since t...

Страница 18: ...d System Status System Failure Solid Red System Status General System Error Table 1 System Status Indicator Biological Indicators The BI is a single use testing device used to monitor the effectivenes...

Страница 19: ...ts with the growth medium causing it to fluoresce under ultraviolet light Each well contains an ultraviolet light source to excite fluorescence in the growth medium and a photodetector to detect that...

Страница 20: ...LEDs for illumination and aiming making it possible to scan a barcode in a wide variety of lighting conditions In order to scan a BI barcode hold the BI approximately 10 cm 4 in from the scanner with...

Страница 21: ...tes Warm up When initially powered on the reader will display a splash screen and then go through a diagnostic and warm up sequence which takes up to 15 minutes After completing the warm up sequence t...

Страница 22: ...e reader The Reader is also able to use a handheld barcode scanner attached to a USB port Hold the biological indicator 10 cm 4 in from the scanner with the barcode facing the scanner Align the barcod...

Страница 23: ...p has remained red pink refer to the Chemical Indicator Result section Chapter 4 for more detailed instructions Touch Next to continue If the color has changed to yellow touch Yellow and refer to the...

Страница 24: ...Touch Activated once complete Figure 8 Activate the BI Place the BI in the selected well immediately after activation An audible beep and a brief teal circle on the well indicator number will confirm...

Страница 25: ...cal indicators that have been exposed to hydrogen peroxide please wear the appropriate PPE chemical resistant latex PVC vinyl or nitrile gloves Refer to the glove manufacturer s instructions for use f...

Страница 26: ...the Chemical Indicator Result section Chapter 4 for a more detailed explanation If the color has not changed touch Red Pink and refer to the Troubleshooting section of this guide Chapter 8 Figure 12 C...

Страница 27: ...rrect Touch No to return to the previous screen 9 Note Ensure that the time is synchronized between the reader and the Sterilizer to proceed to the next screen Figure 13 Manual Entry of Cycle Informat...

Страница 28: ...l circle on the well indicator number will confirm placement in the well The reader will detect that the BI has been placed in the well and will begin the countdown until the result is displayed Figur...

Страница 29: ...ing each result Chemical Indicator Result Read the chemical indicator CI result by comparing the CI color against the CI of an unprocessed BI The CI shifts from red pink unprocessed to yellow processe...

Страница 30: ...ave notes about this specific result Touch Done or remove the BI to return to Result Confirmation Figure 18 Negative Test Result Positive Test Result A positive result for a test BI will be accompanie...

Страница 31: ...tion that the instructions have been viewed Touch Yes or remove the BI to continue to the Result Confirmation Touch No to return to the previous screen In Result Confirmation view the result summary b...

Страница 32: ...page If a printer is connected to the reader touch Print on the lower left to print the Result Summary Touch Add Note to leave notes about this specific result Touch Done or remove the BI to return t...

Страница 33: ...n Touch an open well indicator or place the second positive control BI in an open well The reader will ask to confirm that a second positive control is being added Touch No to go to the Status Screen...

Страница 34: ...OK or remove the BI from the well to return to the Status Screen Touching View and Print Result Summary opens the Result Summary page If a printer is connected to the reader touch Print on the lower l...

Страница 35: ...ellow to confirm that the BI has been exposed to hydrogen peroxide Incubate the test BI and a positive control at 55 60 C 131 140 F for 5 to 7 days After incubation inspect the growth medium in the pr...

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Страница 37: ...erature well status barcode scanner status and software version System Information System Name Serial Number Model Number Manufacturer Date of Manufacture System Status Well Temperature Number of Well...

Страница 38: ...ystem Information System Serial Number Software Version Corresponding Control Information Date Time Completed Lot Number Serial Number Result STERRAD Cycle Information STERRAD ID Cycle Type Cycle Numb...

Страница 39: ...de 33 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...

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Страница 41: ...n abrasive detergent Do not spray cleaning products directly on the reader Do not attempt to clean or service the interior of the reader The interior of the reader contains no user serviceable parts a...

Страница 42: ...cycler 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 age...

Страница 43: ...access Operator level access permits a user to perform tasks associated with the daily operation of the reader These privileges allow an operator to Select start and cancel a reading Scan the BI and...

Страница 44: ...r privileges view and print past results perform diagnostic tests and update the software The following is a step by step explanation of the Utilities Menu and its functions Figure 23 Utilities Menu A...

Страница 45: ...ngth The password must be eight to twelve characters in length with at least one uppercase letter one lowercase letter and one number Touching a text field brings up the on screen keyboard Typing text...

Страница 46: ...odify the settings and touch Save Edits to save the changes Cancel returns to the previous screen Select an existing STERRAD and touch Delete to open the Delete Confirmation screen Touch Yes to confir...

Страница 47: ...4 System Configuration Utility Language Selection Language Selection allows the operator to select the language displayed on the reader software Use the drop down menu to select the most appropriate l...

Страница 48: ...of the reader Touch USB to use an external barcode scanner connected through a USB port Please note that when the external barcode scanner is enabled the internal barcode scanner will be disabled Read...

Страница 49: ...aphic location from the drop down menu IMPORTANT Ensure that the time is synchronized between the reader the Sterilizer and the ASP ACCESS to prevent errors occurring during manual entry Calibrate Ins...

Страница 50: ...P ACCESS Configuration screen After returning to ASP ACCESS Configuration verify that the settings are correct and test the connection again If the test fails a second time refer to the Troubleshootin...

Страница 51: ...ut that specific file Select the destination and touch the arrow button between the lists to copy the file to the new location Touch Done to return to the Utilities Menu Update Software Software updat...

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Страница 53: ...perform an insertion sensor calibration after the reader has completed its warm up sequence Refer to the Calibrate Insertion Sensor section Chapter 7 for more information You haven t finished filling...

Страница 54: ...adding a test BI select Test before scanning the BI barcode If adding a positive control BI select Control and scan a BI which has not been exposed to a sterilization cycle or been previously process...

Страница 55: ...d Do not touch or move BIs during incubation Remove BIs from wells and perform proximity calibration Move reader away from vibration sources Ensure BI was properly activated Our records indicate that...

Страница 56: ...in well sensor blocked Remove BI from affected well and wait 10 seconds to clear Check and remove debris from the well if present Perform a well calibration if possible After waiting for any BI activ...

Страница 57: ...r Reinsert the BI in the selected well Do not cancel the sequence Simply check the activation and follow on screen instructions A control biological indicator has not been incubated for this lot in th...

Страница 58: ...Reinstall the power adapter in the back of the reader If the problem persists contact ASP System status indicator is solid red General System Error Unplug the power adapter from the back of the reade...

Страница 59: ...or healthcare facility policy and procedures and reprocess the load with a new BI Per BI IFU inspect BI for cracked ampuole pior to processing Do not process cracked BI Contact ASP Failure to scan BI...

Страница 60: ...non sterile instruments and notification of the clinician s Repeat the test with a second BI Check BI for any damage per IFU prior to use for cycle Ensure the BI is handled and activated properly Do...

Страница 61: ...er checked by ASP and do not use the sterilizer until unit has been checked BI ampoule breaks during sterilization Ampoule defect Reprocess load with new BI Chemical indicator indicates exposure prior...

Страница 62: ...of the reader and attempt to use the touch screen again Clean the screen If the problem persists contact ASP Reader will not connect to network Network down faulty cable improper settings Note ASP ACC...

Страница 63: ...ue has occurred causing all incubating biological indicators to be void Please remove all biological indicators Vibration or turning of BIs while incubating Move reader away from any vibration source...

Страница 64: ...instructions 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 Call Your ASP Repr...

Страница 65: ...es 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 Ou...

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Страница 67: ...t 30 C 86 F to 70 at 40 C 104 F non condensing Ambient Operating Pressure 103 kPa to 70 kPa 1 02 atm to 0 69 atm Ambient Operating Altitude 3 000 m to 100 m 9843 to 328 60W AC Power Adapter Input 100V...

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Страница 69: ...erify the network connection While the connection is verified an animation will appear which says One Moment Verifying Connection A successful network connection test will display a green circle with...

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Страница 71: ...30 EU Waste Electrical and Electronic Equipment WEEE Directive 2012 19 EU 47 CFR Part 15 FCC Part 15 Subpart B Class A IEC EN 61010 1 2010 CAN CSA C22 2 No 61010 1 12 2012 IEC EN 61010 2 010 2014 CAN...

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Страница 73: ...Network Setup screen select the mode for connecting to the network Auto will retrieve the network connection information from the network and Manual will allow the user to enter the network connectio...

Страница 74: ...te a Pairing Code Enter the ASP ACCESS Username and Pairing Code and touch Test to verify the connection The reader will show a loading screen with the message One Moment Verifying Connection while it...

Страница 75: ...tup Set the date time and time zone for the current geographic location Choose the date and time format to be displayed on the reader Touch Back to go to the previous screen or touch Next to continue...

Страница 76: ...administrator account Touch Back to return to the previous screen Figure 30 Administrator Setup Once the initial administrator account is created add more administrator accounts by touching Add New M...

Страница 77: ...information populates the drop down menus for manual cycle entry Sterilizers added to the system appear in a table Add more sterilizers by touching Add New To edit or delete existing sterilizers touch...

Страница 78: ...I color change for a control BI Otherwise touch No Touch Next to continue or touch Back to return to the previous screen Printer Setup A printer can be attached via a USB port if desired Attach the pr...

Страница 79: ...e the Documentation and all other information provided to you in relation to the Software constitutes confidential information of ASP and you shall not disclose any such information without the expres...

Страница 80: ...OR PURSUANT TO THIS LICENSE AGREEMENT SHALL EXCEED IN THE AGGREGATE THE PRICE PAID BY YOU FOR THE PRODUCT Subject to binding arbitration provided hereinbelow this License as well as any claim related...

Страница 81: ...tration Act however any party will have 30 days to appeal the award by notifying the arbitration organization and all parties in writing The originally selected arbitration organization will appoint a...

Страница 82: ...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 subje...

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