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ASTUTE Astute140 Meter User Manual

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140 M
140
STUTE
STUTE
©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16
M
®
ETER
ETER
USER MANUAL

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  • Page 1 140 M ® STUTE STUTE ETER ETER USER MANUAL ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 2 Astute Medical, Inc. 3550 General Atomics Ct. Building 2 San Diego, CA 92121 USA Phone: +1 (855) 317-2788 (Monday thru Friday, 8am – 5pm PST) Fax: +1 (858) 332-0690 Email: technicalsupport@astutemedical.com Website: www.astutemedical.com ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 3: Table Of Contents

    Quality Control Settings ......................31 LIS Settings ............................. 32 Network Settings .......................... 34 PC Mode ............................36 Printer Settings ..........................37 Managing Users ..........................38 Meter Information ....................40 ® stute Error Log ............................42 ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 4 Glossary of Terms (Listed Alphabetically) ............... 90 Index ................................92 Appendix ..............................94 Main Menu Structure ........................94 Review Data Menu Structure ......................95 Operator Menu Structure ........................ 96 Supervisor Menu Structure ......................97 ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 5: Introduction

    Results of the test are displayed on the A Meter’s LCD screen and may be ® stute printed using the meter’s internal printer, or electronically transmitted to a connected laboratory information system (LIS). ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 6: A Stute 140 ® Meter Kit Contents

    *Packaged and shipped in a separate box. If the shipping container or its contents are damaged, or if any components are missing, contact Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). To avoid damaging the A Meter, DO NOT use any power adapter ®...

  • Page 7: Materials Required But Not Provided

    Liquid Control Kits (PN: 500013) ® ephro heCk For a list of approved tests and corresponding liquid controls for use with the Meter, go to www.astutemedical.com or consult your Astute Medical, Inc. ® stute sales representative. Optional Accessories Optional accessories that may be used with the A Meter include the ®...

  • Page 8: Product Specifications

    59°F – 86°F Humidity: 30% – 80% rH, non-condensing at 59°F operating temperature 15% – 80% rH, non-condensing at 86°F Storage Environment Temperature: -4°F to 140°F Humidity: 20% – 85% rH, non-condensing ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 9: Warnings, Hazards, Precautions And Limitations

    Meter in accordance with federal, state and local ® stute requirements regarding biohazardous materials. Due to potentially infectious nature of the samples used with the A ® stute Meter, users should wear gloves. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 10: Fcc Testing

    For questions or additional information, please contact Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). The A Meter complies with the emission and immunity requirements ®...

  • Page 11: Limitations

    The time delay in testing that would result from loading more than one cartridge at a time may lead to inaccurate test results. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 12: A Stute 140 ® Meter Features

    Deletes the character to the left of the cursor Drawer Used to insert a N Test cartridge and the Electronic Quality Control (EQC) ® ephroCheCk device into the A ® Meter stute Battery Cover Covers the battery compartment ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 13 USB Port Used to connect the A ® Meter to a computer to download new software stute On/Off Switch Used to power the A Meter on and off ® stute ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 14 Regulatory labels and symbols used to provide information about the device labels ® Meter and its proper use (See “Labels and Symbols” on p. 73 stute and symbols for defi nitions) ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 15: User Types

    Operator. Supervisors and Operators are permitted to perform different functions, as described below. Operator Users logged in as Operators may perform the following functions: Power the A Meter on/off ® stute Run electronic quality control (EQC) ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 16: Supervisor

    Set or change LIS settings Set PC Mode (On/Off ) Set or change network settings Set or change print headers Manage Users (change/add/delete) View A Meter information (hardware/fi rmware/bootware/serial ® stute number/IP address) ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 17: Installation

    1. Locate the AC power adapter pack containing the AC power cord, the switching power supply, and the country-specifi c adapter, then connect them as shown: Figure 5. Connecting power cords 2. Insert the end of the country-specifi c adapter into a power source. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 18: Installation And Replacement Of Batteries

    When using alkaline or lithium batteries under a temperature operating range of to 25 C, the A ® Meter will allow approximately 10 user tests to be stute performed before requiring battery replacement. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 19 LCD display to open the A Meter ® stute drawer and ensure there is not a cartridge in the meter. 2. Power off the A ® Meter. stute ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 20 Figure 10. Removing battery cover 5. If replacing the batteries, remove the old batteries and properly discard them (See “Disposing of the Batteries” on p. 72). ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 21: Installation And Replacement Of Paper

    2. If changing the paper, remove the empty spool and any unused paper. 3. Place the paper roll into the holder with the end of the paper coming from under the roll toward the A Meter display. ® stute Figure 12. Installing paper ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 22: Powering On The A Stute 140 ® Meter

    Figure 14. Self Test screen ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 23: Supervisor Instructions: Configuration And Settings

    If after restarting the A Meter the self test fails again, ® stute contact Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). Meters are factory-calibrated to ensure that the same N Test ®...
  • Page 24 Main Menu screen with Supervisor Menu icon highlighted 6. When the Supervisor Menu is displayed, General Settings is highlighted. Use the key to highlight Manage Users and press the right soft key. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 25 15. Press the left soft key to return to the main Supervisor Menu. 16. Press the left soft key to return to the Main Menu. 17. Press the left soft key to log out of the system. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 26: Setting Or Changing Time

    7. When the Time & Time Format screen is displayed, Time Format is highlighted. Use the keys to choose either a 12- or 24-hour time format for display on the screen and printouts. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 27: Setting Or Changing Date

    3. Press the right soft key to display the Supervisor Menu. 4. When the Supervisor Menu is displayed, General Meter Settings is highlighted. Press the right soft key to display the General Settings screen. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 28: Setting Or Changing The Language

    The Supervisor can change the default language by performing the following steps: 1. Press the key to display the Main Menu. 2. Use the navigation keys to highlight the Supervisor Menu icon. Figure 21. Main Menu screen with Supervisor Menu icon highlighted ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 29: Updating System Software

    Meter will be required periodically. When updates ® stute 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 30 7. On the Registering screen, use the keys to toggle between Yes and No to either allow or not allow Operators to register lots and controls. 8. Press the right soft key. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 31: Quality Control Settings

    Press the right soft key to display the Default Settings screen. 5. On the Default Settings screen, use the key to highlight QC Settings and press the right soft key. Figure 25. Default Settings screen with QC Settings highlighted ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 32: Lis Settings

    Press the right soft key to display the General Settings screen. 5. When the General Settings screen is displayed, Default Settings is highlighted. Use the key to highlight LIS Settings and press the right soft key. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 33 ® stute the timeout interval, IP Address, Port Number, and whether results will be automatically transmitted to the LIS may be selected. Figure 28. LIS Settings screen when LIS is available ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 34: Network Settings

    To configure the network settings, perform the following steps: 1. Press the key to display the Main Menu. 2. Use the navigation keys to highlight the Supervisor Menu icon. Figure 30. Main Menu screen with Supervisor Menu icon highlighted ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 35 (if connected) to enter the correct port number. 7. Once all of the entries have been confirmed, press the right soft key to accept all entries. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 36: Pc Mode

    6. When the PC Mode screen is displayed, use the keys to toggle between turning PC Mode Off or On. 7. Once the selection has been confirmed, press the right soft key. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 37: Printer Settings

    5. When the General Settings screen is displayed, Default Settings is highlighted. Use the key to highlight Printer Settings and press the right soft key. Figure 36. General Settings screen with Printer Settings highlighted ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 38: Managing Users

    1. Press the key to display the Main Menu. 2. Use the navigation keys to highlight the Supervisor Menu icon. Figure 38. Main Menu screen with Supervisor Menu icon highlighted ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 39 3. When the Change User screen is displayed, Mode is highlighted. The current user mode (Supervisor or Operator) is displayed. To change the user mode, use the keys to toggle between Supervisor and Operator. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 40: A Stute 140 ® Meter Information

    Meter information, including the installed hardware, firmware ® stute and bootware versions, the serial number, and the IP address, follow the steps below: 1. Press the key to display the Main Menu. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 41 5. A temporary screen will appear while the A Meter is reading the ® stute network confi guration. Figure 40. Temporary screen while A ® Meter stute is reading network confi guration ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 42: Error Log

    2. Use the navigation keys to highlight the Supervisor Menu icon. Figure 42. Main Menu screen with Supervisor Menu icon highlighted 3. Press the right soft key to display the Supervisor Menu. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 43 Figure 44. Instrument Errors Log screen To display the Handling Errors Log, use the key to highlight Handling Errors and press the right soft key. Figure 45. Handling Errors Log screen ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 44 4. When the Operator Menu is displayed, Manage Lots is highlighted. Use the key to highlight View Error Log and press the right soft key. Figure 47. Operator Menu screen with View Error Log highlighted 5. Follow steps 5–7 in the previous section. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 45: A Stute 140 ® Meter Operation

    Figure 48. Self Test screen If all systems pass, the Log In screen will then automatically appear, indicating that the Meter is ready for use. ® stute Figure 49. Log In screen ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 46: Logging In

    If after restarting the A ® Meter the self test stute fails again, contact Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). Meters are factory-calibrated to ensure that the same N Test ®...
  • Page 47 8. Press the key to highlight Beeper. Use the keys to turn the beeper on or off. 9. Once all selections have been confirmed, press the right soft key to accept all selections. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 48: Rfid Cards For Device And Lot Registration

    If lost, a replacement A EQC Device may be ordered ® stute from Astute Medical, Inc. at www.astutemedical.com or by contacting your Astute Medical, Inc. sales representative. The A EQC Device must be registered prior to first use. Operators may register ®...
  • Page 49 Registered EQC Devices screen with options pop-up menu 7. When the Options pop-up menu is displayed, Print List is highlighted. Use the key to highlight Register Device and press the right soft key. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 50: A Stute 140 ® 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 Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information).
  • Page 51 4. When prompted, place the A ® EQC Device into the recess inside the stute ® Meter drawer with the Astute Medical logo marked on the A ® stute stute EQC Device pointed toward the meter. Gently close the drawer until it clicks.

  • Page 52: Test Lot Registration

    Meter passed the EQC procedure or Failed ® stute if it did not. If the procedure failed, contact Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). 7. To manually print the EQC results if Autoprint is disabled: a.
  • Page 53 8. On the Registered Test Lots screen, press the right soft key to display the Options pop-up menu. 9. When the Options pop-up menu is displayed, Print List is highlighted. Use the key to highlight Register Lot and press the right soft key. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 54: Liquid Control Lot Registration

    12. If registered incorrectly, an error message will appear. Press the right soft key to select OK and close the error message. Repeat steps 10–11. If registered incorrectly a second time, contact Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information).
  • Page 55 See the assay-specific Package Insert for storage instructions when the liquid control kit 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. sales representative. For each N Liquid Control Kit, the liquid control registration process must ®...

  • Page 56: External Liquid Quality Control (Lqc)

    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 Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information).
  • Page 57 2. Use the navigation keys to highlight the Run LQC icon. Figure 62. Main Menu screen with Run LQC icon highlighted 3. Press the right soft key to select Run LQC. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 58 N Liquid Control Kit Package Insert. ® ephro heCk NOTE: The test lot must be registered prior to running LQC (See “Test Lot Registration” on p. 52 for instructions). ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 59 When the LQC procedure completes, the results will be displayed along with the word Passed if the meter passed the LQC procedure or Failed if it did not. If the procedure failed a second time, contact Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information).

  • Page 60: Calibration Verification Testing

    2. When the Main Menu is displayed, use the navigation keys to highlight the Run Patient icon. Press the right soft key to select Run Patient. Figure 65. Main Menu screen with Run Patient icon highlighted ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 61 9. Press the right soft key to display the Options pop-up menu. Use the key to highlight Next Patient and press the right soft key. Repeat steps for the remaining four levels of N Calibration Verification Kit Vials. ® ephro heCk ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 62: Testing A Patient Sample

    A Meter and to purchase assay-specific test ® stute cartridges, go to www.astutemedical.com or consult your Astute Medical, Inc. sales representative. NOTE: Unless modified by the Supervisor, the Run Patient option will be greyed out (unavailable) until valid A Meter Electronic Quality Control (EQC) and ®...
  • Page 63 8. When prompted, place the prepared N Test cartridge into the recess ® ephro heCk inside the A Meter drawer with the Astute Medical logo marked on the ® stute Test cartridge pointed toward the meter. Gently close the drawer ® ephro heCk until it clicks.
  • Page 64 If high and low LQC measurements are required, follow these steps: i. Press the right soft key to select OK and close the error message. ii. Discard the N Test cartridge prepared with the patient ® ephro heCk sample. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 65: Review And Management Of Test Results

    Patient, LQC, EQC and Calibration Verification test results can be recalled, printed or sent to the LIS at any time. To perform these functions, follow the instructions below. Patient Results 1. Press the key to display the Main Menu. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 66 Details of the patient test results will be displayed. To print the test results, press the right soft key to select Print. v. After printing is complete, press the left soft key to return to the list of patient results. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 67: Lqc Results

    Test Lot. ii. The default selection is to display LQC results from all test lots. To select a specific test lot, use the keys to display the desired test lot. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 68: Eqc Results

    3. When the Review Data Menu is displayed, Patient Results is highlighted. Use the key to highlight Electronic QC Results and press the right soft key to display the Review EQC Results screen. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 69: Calibration Verification Results

    Print. v. After printing is complete, press the left soft key to return to the list of patient results. Calibration Verification Results See “Patient Results” on p. 65 for instructions. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 70: Send Results To Lis

    Review Data Menu. Shutdown To power off the A Meter, toggle the power switch on the back of the meter ® stute upwards, and the meter should immediately shut down. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 71: Maintenance And Troubleshooting

    Do not clean with soap or other solutions. To open the A ® stute Meter drawer, press the key on the left side of the LCD display. Figure 74. Eject key ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 72: Replacing The Paper

    Disposing of the A Meter ® stute The A Meter should be considered infectious waste. Dispose of the ® stute Meter according to the laboratory’s best practices for disposal of ® stute biohazardous waste. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 73: Labels And Symbols

    – Part 1: General requirements b) IEC 60417:2002 DB Graphical Symbols for Use on Equipment c) ISO 7000: Fifth edition: 2014 Graphical symbols for use on equipment—Registered symbols d) Symbol containing explanatory text for clarity ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 74: Troubleshooting Tips

    2. If the problem continues, connect the AC power adapter to a different power source. 3. If the problem persists, call Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). When battery power is being used: 1.
  • Page 75 AA batteries if the power adapter is not being used). Wait 30 seconds and reconnect the AC power adapter (or reinsert the batteries if the AC power adapter is not being used). If the keypad still does not respond, call Astute Technical Support (See “Contacting Astute Medical, Inc.” on p. 7 for contact information).

  • Page 76: Error Messages

    Create a new user. If the error persists, call Astute Technical Support (See Contacting Astute Medical, Inc.” on p. 7 for contact information). *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 77 ID Error. adding or editing a The User ID is User. missing. User ID is mandatory for adding or editing a User. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 78 Create a new Password password using Error. The numbers only. password created contains letters or special characters. Passwords may only consist of numbers. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 79 Transmission If the error Error. The bar persists, check code was not that the barcode read correctly. isn’t damaged or incomplete. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 80 Always check date. the expiration date printed on the kit box prior to beginning a test procedure. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 81 LQC lot. A passing measurement for both positive and negative LQC is required prior to running a patient sample. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 82 48 for instructions). 00X.061.083 Lot Already The Lot does Registered. not need to be registered. Proceed with testing. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 83 If the problem persists, call Astute Technical Support. (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 84 Meter from automatically searching for the network after log in. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 85 Fatal Software Discontinue use Error. and call Astute Technical Support. (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 86 Base Full. entries in order to The database clear memory and containing the register new lots. Lots previously registered is full. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 87 Support. (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). 00X.060.048 Measurement Wait until the in process. measurement has completed. *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 88 If this reoccurs, call Astute Technical Support. (See “Contacting Astute Medical, Inc.” on p. 7 for contact information). *Error codes may begin with 001, 002, 003 or 004. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 89: End User License Agreement

    If you do not agree with each of the terms and conditions set forth in this End User License Agreement, please contact Astute within ten (10) days after receipt of this product to return the unused and unopened product for a full refund.

  • Page 90: Glossary Of Terms (Listed Alphabetically)

    External quality control materials and procedures that are used to verify the Control (LQC) performance of the test system, including the performance of the N ® ephro heCk Test cartridges and the A Meter. ® stute ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 91 A Meter via ® stute an internal reader. Supervisor User Type of user with privileges to perform advanced A ® Meter operations, in stute addition to Operator user functions. ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 92: Index

    Performing a test, 62 print errors, 82 Positive and negative quality controls, 91 RFID errors, 82 Power supply, 6, 8–9, 17 start up/self-test/ error, 85 Powering on the A Meter, 22, 45 ® stute ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 93 Soft keys, 12 Storage humidity, 8 Storage temperature, 8 Supervisor, 15–16 Supervisor menu, 24 Supplies, 6–7 Symbols, 9, 73 System components, 6 Technical Support, 7 Transporting the meter, 9 Troubleshooting, 71 Unpack, 6 ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 94: Appendix

    Appendix Meter ® stute Appendix Main Menu Structure ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 95: Review Data Menu Structure

    Appendix Meter ® stute Review Data Menu Structure ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 96: Operator Menu Structure

    Appendix Meter ® stute Operator Menu Structure ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

  • Page 97: Supervisor Menu Structure

    Appendix Meter ® stute Supervisor Menu Structure ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...
  • Page 98 Meter ® stute Manufactured for Astute Medical, Inc. 3550 General Atomics Ct. Building 2 San Diego, CA 92121 ©Astute Medical, Inc. 2017 PN 300153 Rev G 2017/01/16...

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