Astute Medical ASTUTE140 User Manual
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Astute Medical ASTUTE140 User Manual

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®
ASTUTE140
Meter
User Manual
©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03
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Summary of Contents for Astute Medical ASTUTE140

  • Page 1 ® ASTUTE140 Meter User Manual ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 2 Manufactured for Astute Medical, Inc. MDSS GmbH 3550 General Atomics Ct. Schiffgraben 41 Building 2 30175 Hannover San Diego, CA 92121 Germany CONTACT INFORMATION: Phone: +1 (855) 317-2788 Phone: +1 (858) 500-7000 Email: technicalsupport@astutemedical.com ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 3: Table Of Contents

    Quality Control Settings ..................... 31 LIS Settings ........................32 Network Settings ........................ 34 PC Mode ..........................36 Printer Settings ........................37 Managing Users ......................... 38 ® ASTUTE140 Meter Information ..................40 Error Log ..........................42 ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 4 Glossary of Terms (Listed Alphabetically) ..............78 Index ............................80 Appendix ..........................82 Main Menu Structure ....................... 82 Review Data Menu Structure ....................83 Operator Menu Structure ......................84 Supervisor Menu Structure ..................... 85 ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 5: Introduction

    Meter is a bench top instrument intended to be used by trained medical professionals as an in vitro diagnostic device in a laboratory environment for the measurement of ® fluorescence in various assays manufactured by Astute Medical, Inc. The ASTUTE140 Meter converts fluorescent signals from immunoassays into numerical test results.

  • Page 6: Astute140 ® Meter Kit Contents

    User Manual Printer paper rolls (2) 100000 AA batteries (4) ® (1) This component is only available as part of the ASTUTE140 Meter Kit. Additional ® ASTUTE140 Meter Kits can be ordered using Part Number 500000. *Packaged and shipped in a separate box.

  • Page 7: Materials Required, But Not Provided

    ® Meter Materials Required, But Not Provided ® For a list of approved tests and corresponding liquid controls for use with the ASTUTE140 Meter, consult your local sales representative. Optional Accessories ® Optional accessories that may be used with the ASTUTE140 Meter include an external barcode reader and an external keyboard.

  • Page 8: Product Specifications

    +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 ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 9: Warnings, Hazards, Precautions And Limitations

    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. ® Use only the AC power adapter supplied with the ASTUTE140 Meter. ®...

  • Page 10: Fcc Testing

    Handle the ASTUTE140 Meter in accordance with federal, state and local requirements regarding biohazardous materials. ® Due to potentially infectious nature of the samples used with the ASTUTE140 Meter, users should wear gloves. FCC Testing This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1.

  • Page 11: Limitations

    ® ® The ASTUTE140 Meter does not contain a “batch mode” function. The ASTUTE140 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 loaded with the patient sample or liquid control.

  • Page 12: Astute140 ® Meter Features

    Deletes the character to the left of the cursor 12 Drawer Used to insert a Test cartridge and the Electronic Quality Control ® (EQC) device into the ASTUTE140 Meter 13 Battery Cover Covers the battery compartment ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 13 Used to connect the ASTUTE140 Meter to an LIS or to a computer network to download software ® AC Power Adapter Port Used to connect the AC power adapter to the ASTUTE140 Meter ® USB Port Used to connect the ASTUTE140...
  • Page 14 In-Vitro Diagnostic device Regulatory labels and symbols used to provide information about ® labels and symbols the ASTUTE140 Meter and its proper use (See “Labels and Symbols” on p. 71 for definitions) ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 15: User Types

    ASTUTE140 Meter information, or view error logs User Types ® There are two types of users defined for the ASTUTE140 Meter, Supervisor and Operator. Supervisors and Operators are permitted to perform different functions, as described below. Operator Users logged in as Operators may perform the following functions: ®...

  • Page 16: Supervisor

    Manage (register/delete/print) LQC lots Manage (register/delete/print) EQC devices ® The Operator may change the following settings temporarily while using the ASTUTE140 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:...

  • Page 17: Installation

    (See “Installation and Replacement of Batteries” on p. 18). NOTE: If the AC power adapter is in use and the electrical power fails or the power adapter becomes ® disconnected, the meter will power off even if batteries are installed in the ASTUTE140 Meter. To connect the AC power adapter: 1.

  • Page 18: Installation And Replacement Of Batteries

    NOTE: If the AC power adapter is in use and the electrical power fails or the power adapter becomes disconnected, the meter will power ® off even if batteries are installed in the ASTUTE140 Meter. When using alkaline or lithium batteries under a temperature operating range of 20...
  • Page 19 – empty and blinking ® When the battery strength indicator is displayed as empty and blinking, the ASTUTE140 Meter can run one additional test within one hour under the same operating conditions before the batteries will need to be replaced.
  • 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. 70). ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • 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 ASTUTE140 Meter display. Figure 12. Installing paper ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 22: Powering On The Astute140 ® Meter

    Figure 14. Self Test screen ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 23: Supervisor Instructions: Configuration And Settings

    ASTUTE140 ® Meter ® If all systems pass, the Log In screen will automatically appear, indicating that the ASTUTE140 Meter is ready for use. Figure 15. Log In screen If the self test fails, an error message will be displayed. Press the right soft key to select OK and ®...
  • 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. 2021 PN 300005 Rev G 2021/03/03...
  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 29: Updating System Software

    9. Press the right soft key to select the highlighted default language. Updating System Software ® The software version currently running on the ASTUTE140 Meter can be found on the Self Test ® screen during start-up (See “Powering On the ASTUTE140 Meter”...
  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 31: Quality Control Settings

    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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 32: Lis Settings

    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. 2021 PN 300005 Rev G 2021/03/03...
  • Page 33 Meter is connected to an LIS, Yes will be checked and 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. 2021 PN 300005 Rev G 2021/03/03...

  • 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. 2021 PN 300005 Rev G 2021/03/03...
  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 37: Printer Settings

    Meter Printer Settings ® To specify whether test results are automatically sent to the ASTUTE140 Meter’s internal printer, or to create a customized header (including institute name, address and telephone number) to be printed on all printouts, follow these steps: 1.

  • Page 38: Managing Users

    ® Meter 6. When the Printer Settings screen is displayed, Auto Print is highlighted. To select ® whether results will be automatically sent to the ASTUTE140 Meter’s internal printer, use keys to toggle between No and Yes. Figure 37. Printer Settings...
  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 40: Astute140 Meter Information

    To display the ASTUTE140 Meter information, including the installed hardware, firmware 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. 2021 PN 300005 Rev G 2021/03/03...
  • Page 41 4. When the Supervisor Menu is displayed, General Settings is highlighted. Use the key to highlight Meter Info and press the right soft key. ® 5. A temporary screen will appear while the ASTUTE140 Meter is reading the network configuration.

  • Page 42: Error Log

    7. Press the left soft key to return to the Supervisor Menu. Error Log ® A history of the errors that have occurred while the ASTUTE140 Meter has been in use, including the error code and the date/time of occurrence, may be accessed through the Supervisor Menu or the Operator Menu.
  • 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. 2021 PN 300005 Rev G 2021/03/03...
  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 45: Astute140 Meter Operation

    Figure 48. Self Test screen If all systems pass, the Log In screen will then automatically appear, indicating that the ® ASTUTE140 Meter is ready for use. Figure 49. Log In screen ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 46: Logging In

    In order to operate the ASTUTE140 Meter, the user must log in with a unique user ID and ® password. This requirement protects access to patient information stored in the ASTUTE140 Meter’s memory. ® After successfully powering on the ASTUTE140 Meter, the Log In screen will automatically appear.
  • Page 47 8. Press the key to highlight Beeper. Use the 9. Once all selections have been confirmed, press the right soft key to accept all selections. ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 48: Rfid Cards For Device And Lot Registration

    Each new ASTUTE140 Electronic Quality Control (EQC) Device, liquid control lot and test lot ® must be registered prior to first use. Operators may register ASTUTE140 Electronic Quality Control (EQC) Devices, liquid control lots and test lots only if Supervisors grant registration permission to Operators in the default settings;...
  • Page 49 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 50: Astute140 ® Electronic Quality Control (Eqc)

    EQC Device information and select OK by pressing the right soft key. Figure 55. Register Electronic QC Device screen ® 9. If registered correctly, a screen indicating that the ASTUTE140 EQC Device number was ® successfully read from the ASTUTE140 EQC RFID Card will appear. Press the right soft ®...
  • Page 51 ® ASTUTE140 Device ® 5. After closing the drawer, a temporary screen will appear indicating that the ASTUTE140 Meter is running the EQC procedure and displaying the amount of time remaining until test completion will be displayed. Figure 57. Temporary screen...

  • Page 52: Test Lot Registration

    Assay-specific test cartridges that are uniquely compatible with the ASTUTE140 Meter are used ® to test patient samples. The Test cartridges approved for use with the ASTUTE140 Meter should not be used with any other testing device. Similarly, only Test cartridges approved for use with ®...
  • 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 54: Liquid Control Lot Registration

    Operators may register the liquid controls only if the Supervisor granted registration permission in the default settings; otherwise, Supervisors must register the liquid controls. ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 55 7. On the Registered LQC Lots screen, press the right soft key to display the Options pop- up menu. 8. 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 56: External Liquid Quality Control (Lqc)

    It is recommended that LQC be performed at the following times: Every 30 days With each new lot number of Test cartridges With each new shipment of Test Kits In accordance with the laboratory’s standard quality control procedures ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 57 Meter ® The required frequency for running LQC may be set by a Supervisor in the general ASTUTE140 Meter default settings (See “Quality Control Settings” on p. 31 for instructions). Prior to running the first LQC procedure, both the high and low liquid controls in the liquid control kit must be registered if they are from a new liquid control lot (See “Liquid Control Lot...
  • Page 58 1–6. ® 6. After selecting the liquid control lot and level (high or low) to be tested, the ASTUTE140 Meter drawer will automatically open. 7. Prepare the Test cartridge with the liquid control (high or low) as instructed in the assay- specific Liquid Control Kit Package Insert.
  • Page 59 Meter Operation ® ASTUTE140 Meter ® 8. When prompted, place the prepared Test cartridge into the recess inside the ASTUTE140 Meter drawer. Gently close the drawer until it clicks. Figure 64. Running LQC ® 9. After closing the drawer, a temporary screen will appear indicating that the ASTUTE140 Meter is running the LQC procedure and the amount of time remaining until test completion will be displayed.

  • Page 60: Testing A Patient Sample

    ® ® 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 online or consult your sales representative. Each new test lot must be registered prior to use of any Test cartridges from that lot (See “Test Lot Registration”...
  • Page 61 Inoculating additional samples before testing has completed may lead to inaccurate results. ® 8. When prompted, place the prepared Test cartridge into the recess inside the ASTUTE140 Meter drawer. Gently close the drawer until it clicks. Figure 66.
  • Page 62 Meter ® 9. After closing the drawer, a temporary screen will appear indicating that the ASTUTE140 Meter is reading the test lot information to determine if the test lot is registered and whether high and low LQC measurements have passed for the test lot.

  • Page 63: Review And Management Of Test Results

    To return to the Main Menu, press the left soft key. ® 13. Press the eject button to the left of the LCD screen to open the ASTUTE140 Meter drawer. Remove the Test cartridge and discard according to the laboratory’s standard practices for the type of biological sample used.
  • Page 64 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 65: Lqc Results

    Test Lot. ii. The default selection is to display LQC results from all test lots. To select a keys to display the desired test lot. specific test lot, use the ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 66: 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. 2021 PN 300005 Rev G 2021/03/03...
  • Page 67 Detailed EQC results for the selected test will be displayed. To print the detailed 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. 2021 PN 300005 Rev G 2021/03/03...

  • Page 68: Send Results To Lis

    6. Once all desired results have been sent to the LIS, press the left soft key to return to the Review Data Menu. Shutdown ® To power off the ASTUTE140 Meter, toggle the power switch on the back of the meter upwards, and the meter should immediately shut down. ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 69: Care And Maintenance

    Meter and the inside of the meter drawer with a soft cloth slightly dampened with disinfectant (70% alcohol or 0.5% bleach ® solution). Do not clean with soap or other solutions. To open the ASTUTE140 Meter drawer, press the key on the left side of the LCD display.

  • Page 70: Replacing The Paper

    September 2006 on batteries and accumulators and waste batteries and accumulators (also ® known as the EU Battery Directive), batteries are to be removed from the ASTUTE140 Meter and disposed of or recovered separately. Do not dispose of the batteries in municipal waste;...

  • Page 71: Labels And Symbols

    Care and Maintenance ASTUTE140 ® Meter Labels and Symbols ® The following table defines the symbols located on the bottom of the ASTUTE140 Meter. Symbol Definition Symbol Definition Caution, consult Manufacturer accompanying documents Date of manufacture Electrical shock warning Authorized representative in...

  • Page 72: Troubleshooting Tips

    4. If the problem persists, contact Technical Support (See “Contacting Technical Support” on p. 7 for contact information). ® Test cartridge Do not pull or force the drawer open or closed. Reset the ASTUTE140 drawer is Meter by disconnecting the AC power adapter (or removing the AA jammed batteries if the power adapter is not being used).
  • Page 73 54 for registration instructions. If both high and low liquid control lots have been registered and LQC will not run, contact Technical Support (See “Contacting Technical Support” on p. 7 for contact information). ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 74: Error Messages

    Perform LQC for the test lot. If the problem persists, positive and contact Technical Support (See “Contacting Technical negative LQC Support” on p. 7 for contact information). measurements for the test lot is required. ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 75 Locate and position the correct RFID card over the Meter keyboard and retry. If the problem persists, Tag. contact Technical Support (See “Contacting Technical Support on pg. 7 for contact information). ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 76: End User License Agreement

    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. may be obtained by e-mailing us at astuteinfo@biomerieux.com...
  • Page 77 No amendment or addition to this End User License Agreement shall be binding upon the parties unless reduced to writing and signed by the respective authorized officers of the parties. ©2021 Astute Medical, Inc., a bioMérieux Company. BIOMÉRIEUX, the BIOMÉRIEUX logo, AKIRISK, ASTUTE, ASTUTE140, ASTUTE MEDICAL, NEPHROCHECK, and NEPHROCLEAR are used, pending and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies.

  • Page 78: Glossary Of Terms (Listed Alphabetically)

    Liquid Quality External quality control materials and procedures that are used to verify Control (LQC) the performance of the test system, including the performance of the ® Test, and the ASTUTE140 Meter. ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 79 ASTUTE140 Meter for testing. The Test cartridge contains ® reagents that react with the biological sample, allowing the ASTUTE140 Meter to detect the level of the analyte present in the sample. ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 80: Index

    Laboratory Information Systems (LIS), 32, 68 Safety precautions, 9–10 Limitations, 9, 11 Send to LIS, 68 Logging in as supervisor, 23 Set date, 27 Lot Status (see test lot registration), 52 Set language & sound, 28 ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 81 System components, 6 Technical Support, 7 Transporting the monitor, 9 Troubleshooting, 72 Unpack, 6 Up/Down, Left/Right arrows, 12 Updating system software, 29 User types, 15 Warnings, 9 Warranty, 69, 76 Weight, 8 ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 82: Appendix

    Appendix ASTUTE140 ® Meter Appendix Main Menu Structure ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 83: Review Data Menu Structure

    Appendix ASTUTE140 ® Meter Review Data Menu Structure ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 84: Operator Menu Structure

    Appendix ASTUTE140 ® Meter Operator Menu Structure ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

  • Page 85: Supervisor Menu Structure

    Appendix ASTUTE140 ® Meter Supervisor Menu Structure ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...
  • Page 86 ASTUTE140 ® Meter Manufactured for Astute Medical, Inc. MDSS GmbH 3550 General Atomics Ct. Schiffgraben 41 Building 2 30175 Hannover San Diego, CA 92121 Germany ©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03...

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