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ASTUTE ASTUTE140 User Manual

Testing platform for novel biomarkers of acute medical conditions
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[Company Logo]
TM
ASTUTE140
METER
[PHOTO HERE]
User Manual
Astute140
Meter PN: 300005S Rev: B 2012 Astute Medical, Inc. 2012/03/17
TM

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  • Page 1 [Company Logo] ASTUTE140 METER [PHOTO HERE] User Manual Astute140 Meter PN: 300005S Rev: B 2012 Astute Medical, Inc. 2012/03/17...
  • Page 2 For performance evaluation only. Manufactured for Astute Medical, Inc. 3550 General Atomics Ct. Building 2 San Diego, CA 92121 MDSS GmbH Schiffgraben 41 30175 Hannover, Germany CONTACT INFORMATION: info@astutemedical.com Phone: +1 (858) 792-3544 Fax: +1 (858) 882-0449 [Add 800 number]...

  • Page 3: Table Of Contents

    .............................. 3 2 EST EGISTRATION .............................. 3 4 ESTING A ATIENT AMPLE .......................... 3 7 EVIEW AND ANAGE EST ESULTS Patient Results .................................. 3 7 LQC Results .................................... 3 8 EQC Results .................................... 4 0 Send Results to LIS ................................ 4 1 .................................... 4 2 HUTDOWN CARE AND MAINTENANCE ..........................42 Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 4 ESSAGES END USER LICENSE AGREEMENT ........................48 GLOSSARY OF TERMS (LISTED ALPHABETICALLY) ................50 APPENDIX ................................53 .............................. 5 4 AIN ENU TRUCTURE ............................. 5 5 EVIEW ATA ENU TRUCTURE ............................ 5 6 PERATOR ENU TRUCTURE ............................ 5 7 UPERVISOR ENU TRUCTURE Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 5: Introduction

    Astute Medical, Inc. The Astute140 Meter is used in conjunction with a test cartridge to measure the concentration of a target analyte (such as a protein marker) in a sample. Please refer to the assay-specific Product Insert for detailed test information.

  • Page 6: Meter Kit Components

    If the shipping container or its contents are damaged, or if any components are missing, contact Astute Medical, Inc. Technical Support (For contact information, see “Contacting Astute Medical, Inc.” o p. X ). NOTES: DO NOT use any other power adapter with the Astute140 Meter or you may damage the Meter. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 7: Materials Needed But Not Provided

    Batteries are not intended to be used as the main power source for operation of the Astute140 Meter and should only be used as a backup power source if there is no electrical output available. See “Batteries”, p. X for further details.

  • Page 8: Warnings , Hazards , Precautions , And Limitations

    Operating Environment Altitude: Temperature: +15C – 30C Humidity: 30% - 80% rH, non-condensing at 15C operating temperature 15% - 80%, rH, non-condensing at 30C Storage Environment Temperature: -20C to +60C Humidity: 20% - 85% rH, non-condensing   Warnings, Hazards, Precautions, and Limitations  Safety Symbols  Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 9: Safety Information

    Do not move the Astute140™ Meter while a test is running. Do not drop the Astute140™ Meter. The Astute140™ Meter is designed to provide safe and reliable operation when used according to this User Manual. If the Meter is used in a manner not specified in the User Manual, the protection provided by the equipment will be impaired.

  • Page 10: Limitations

    Support (for contact information, see “Contacting Astute Medical, Inc.” on p. X). Limitations  The Astute140 Meter does not contain a “batch mode” function. The Meter times the incubation period for the test, and only one test can be run at a time; therefore, each test cartridge must be run immediately after being inoculated with the patient sample or liquid control.

  • Page 11: Meter Features

    Deletes the character to the left of the cursor 12 Drawer Used to insert a test cartridge and the electronic quality control cartridge into the Meter 13 Battery cover Covers the battery compartment [Photo of back of Meter here with labels] Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 12 2 Run LQC Select to run high and low liquid controls 3 Review Data Select to manage patient, LQC and EQC test results 4 Run EQC Select to run EQC 5 Operator Select to manage (register or delete) test Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 13: User Types

    The Operator may change the following settings temporarily while using the Meter; the settings will return to the default settings programmed by the Supervisor when the Meter is switched off or the Operator is logged out.  Date format  Time format  Language Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 14: Installation

    [Show picture depicting connection of the 3 cords] 2. Insert the end of the country-specific adapter into a power source [Show picture depicting connection of the country-specific adapter into a power source] Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 15: Installation And Replacement Of Batteries

    [Insert picture depicting the low battery indicator when lit] When the low battery indicator is lit, the Meter can run at least 3 additional tests within 1 hour under the same operating conditions before the batteries will need to be replaced. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 16: Installing Or Changing The Paper

    To install or change the internal printer paper, perform the following steps: 1. Remove the printer cover by pulling up on the blue handle on top of the cover. 2. If changing the paper, remove the empty spool and any unused paper. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 17: Powering O N The Meter

    (to power off the Meter, toggle the power switch upwards and it should immediately shut down). If after restarting the Meter the self-test fails again, contact Asute Medical, Inc. Technical Support (See “Contacting Astute Medical, Inc.” on p. X). Astute140...

  • Page 18: Instructions : Configuration And Settings

    [Insert screen shot of Main Menu with Supervisor icon highlighted] 6. When the Supervisor Menu is displayed, General Meter Settings is highlighted. Use the [down arrow navigation key] key to highlight Manage Users and press the right soft key. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 19 The user information just created should now appear in the list, including the user ID, Name, and Mode (Supervisor or Operator). 16. Press the left soft key to return to the main Supervisor menu. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 20: Set Or Change Time

    7. When the Time & Time Format screen is displayed, Time Format is highlighted. Use the [left and right arrow navigation keys] to choose either a 12- or 24-hour time format for display on the screen and printouts. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 21: Set Or Change Date

    6. On the Default Settings screen, use the [down arrow navigation key] key to highlight Date & Date Format. 7. Use the [left and right arrow navigation keys] to scroll through the available date formats for display on the screen and printouts. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 22: Set Or Change The Language

    Press the right soft key to display the Default Settings screen. 6. On the Default Settings screen, use the [down arrow navigation key] key to highlight Language. 7. Press the right soft key to display the Language Menu Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 23: Updating System Software

    Updating System Software  Software updates for the Meter will be required periodically. When updates are available, Astute Medical, Inc. will send written notifications by email and postal service including a description of the software update and downloading instructions. Supervisors can download software updates through the USB and/or Ethernet port.

  • Page 24: Rfid Cards For Device And Lot Registration

    (to power off the Meter, toggle the power switch upwards and it should immediately shut down). If after restarting the Meter the self-test fails again, contact Astute Medical, Inc. Technical Support (See “Contacting Astute Medical, Inc.” on p. X). Log in ...
  • Page 25 When not in use, the EQC Device should be stored in its original packaging away from light. If lost, a replacement EQC device may be ordered from Astute Medical, Inc. at www.astutemedical.com or by contacting your Astute Medical, Inc. sales representative.

  • Page 26: Electronic Quality Control (Eqc)

    10. If registered incorrectly, an error message will appear. Press the right soft key to select OK and close the error message. Repeat steps 8-9. If registered incorrectly a second time, contact Astute Medical, Inc. Technical Support (for contact information, see “Contacting Astute Medical, Inc.” on p. XX).
  • Page 27 EQC procedure or “failed” if it did not. If the procedure failed, contact Astute Medical, Inc. Technical Support (for contact information, see “Contacting Astute Medical, Inc.” on p. XX). Press the eject button to open the drawer. 7. To manually print the EQC results if Autoprint is disabled: a.

  • Page 28: Liquid Control Lot Registration

    Supervisor granted registration permission in the default settings; otherwise, Supervisors must register the liquid controls. See the assay-specific controls product insert for storage instructions when the liquid control set is not in use. Additional liquid controls may be ordered from Astute Medical, Inc. at www.astutemedical.com or by contacting your Astute Medical, Inc.
  • Page 29 11. If registered incorrectly, an error message will appear. Press the right soft key to select OK and close the error message. Repeat steps 9-10. If registered incorrectly a second time, contact Astute Medical, Inc. Technical Support (for contact information, see “Contacting Astute Medical, Inc.” on p. XX).

  • Page 30: External Liquid Quality Control (Lqc)

    To run the LQC procedure, perform the following steps and repeat for the second control in the liquid control set: 1. Press the [picture of menu button] key to display the Main Menu if needed. 2. Use the navigation keys to highlight the Run LQC icon. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 31 LQC procedure and the amount of time remaining until test completion will be displayed. 10. When the LQC procedure completes, the Meter drawer will automatically open and the results will be displayed along with the word “passed” if the procedure Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 32: Test Lot Registration

    Meter should not be used with any other testing device. Similarly, only test cartridges approved for use with the Astute140 Meter can be used with the Meter. For a list of approved tests for use with the Astute140 Meter and to purchase assay-specific test Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 33 Astute Medical, Inc. sales representative. Each new test lot must be registered prior to use of any test cartridges from that lot. Operators may register the test lot only if the Supervisor granted registration permission in the default settings;...

  • Page 34: Testing A Patient Sample

    Meter should not be used with any other testing device. Similarly, only test cartridges approved for use with the Astute140 Meter can be used. For a list of approved tests for use with the Astute140 Meter and to purchase assay-specific test cartridges, go to www.astutemedical.com...
  • Page 35 (if connected). NOTE: an external keyboard and barcode scanner are optional devices that are not included with the Astute140 Meter kit. 5. After confirming that the correct Patient ID and/or Sample ID have been entered, press the right soft key to select Run Patient.
  • Page 36 2. Discard the test cartridge prepared with the patient sample 3. Run high and low LQC measurements (for instructions, See “External Liquid Quality Control”, p. X). 4. When high and low LQC measurements have passed, repeat steps 1- Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 37: Review And Manage Test Results

    2. Using the navigation keys, highlight the Review Data icon and press the right soft key. [Insert screen shot of Main Menu with Review Data icon highlighted] 3. When the Review Data menu is displayed, Patient Results is highlighted. Press the right soft key to display the Patient Results screen. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 38: Lqc Results

    1. Press the [picture of menu button] key to display the Main Menu. 2. Using the navigation keys, highlight the Review Data icon and press the right soft key. [Insert screen shot of main menu with review data icon highlighted] Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 39 Use the [down arrow navigation key] key to highlight Print List. iii. After printing is complete, the list of LQC results will again be displayed. b. To examine and/or print test results for a particular patient sample Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 40: Eqc Results

    To select EQC results falling within a range of dates: i. Use the down arrow navigation key to highlight Start Date. Use the Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 41: Send Results To Lis

    1. Press the [picture of menu button] key to display the Main Menu. 2. Using the navigation keys, highlight the Review Data icon and press the right soft key. [Insert screen shot of Main Menu with Review Data icon highlighted] Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 42: Shutdown

    To power off the Meter, toggle the power switch on the back of the Meter upwards, and the Meter should immediately shut down. Care and Maintenance  No maintenance is required other than routine external cleaning, changing the paper, and changing the batteries. Remove batteries to reduce risk of electrical shock. ClCleaning and Decontamination  Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 43: Changing The Paper

    In conformance with the WEEE (Waste Electrical and Electronic Equipment) Directive, the Meter should be considered infectious waste. Dispose of the Meter according to the Laboratory’s best practices for disposal of biohazardous waste. Labels and Symbols  The following table defines the symbols located on the bottom of the Meter. Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 44 Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 45: Trouble Shooting Tips

    [Insert photo of paper clip being inserted into small hole] If the drawer still does not open, call Astute Medical, Inc. Technical Support (for contact information, see “Contacting Astute Medical, Inc.”...
  • Page 46 Delete a registered cartridge lot and try to register a new cartridge lot. If this approach fails, then call Astute Medical, Inc.Technical Support (for contact information, see “Contacting Astute Medical, Inc.” on p. X.).

  • Page 47: Error Messages

    If the Error expired or disabled. persists, call Astute Medical, Inc. Technical Support (for contact information, see “Contacting Astute Medical, Inc.” on p. X.). Cartridge Errors Barcode reader error The barcode was not Check that the barcode is not read properly.

  • Page 48: End User License Agreement

    CONSTITUTE ACKNOWLEDGMENT AND ACCEPTANCE OF THESE TERMS AND CONDITIONS. Astute Medical, Inc. hereby grants to the purchaser of this product the limited license to use this product solely for the purpose as specified on the approved label therefor. You hereby agree that you shall use this product solely for such purpose and for no other purpose.
  • Page 49 You further agree that you shall not resell or otherwise transfer this product to any other person or entity, without the prior express written approval of Astute Medical, Inc. Information about commercial resale or distribution of the products of Astute Medical, Inc.

  • Page 50: Glossary Of Terms (Listed Alphabetically)

    NephroCheck™ products and/or the technology incorporated therein and their use may be covered by one or more patents or pending patent applications. For more information, please visit www.astutemedical.com.. ASTUTE MEDICAL , the Astute Medical Logo, NEPHROCHECK , and ASTUTE140 are trademarks of Astute Medical, Inc. Glossary of Terms (listed alphabetically)  Analyte A substance or chemical constituent that is undergoing analysis.
  • Page 51 Operator User Type of user with privileges to perform day to day meter operations. Quality Control (QC) An aggregate of activities designed to ensure adequate quality, especially in Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 52 The cartridge contains reagents that react with the biological sample, allowing the Meter to detect the level of the analyte present in the sample.         Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 53: Appendix

      Appendix  Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 54: Main Menu Structure

    Main Menu Structure     Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 55: Review Data Menu Structure

    Review Data Menu Structure  Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 56: Operator Menu Structure

    Operator Menu Structure  Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

  • Page 57: Supervisor Menu Structure

    Supervisor Menu Structure  Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...
  • Page 58 Manufactured for Astute Medical, Inc. 3550 General Atomics Ct. Building 2 San Diego, CA 92121 MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Astute140 Meter PN: 300005S Rev: B Astute Medical, Inc. 2012 2012/03/20...

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