Astute Medical ASTUTE140 User manual

©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03
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ASTUTE140® Meter
User Manual
!

©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03
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For Export Only. Not for Sale in the United States.
Manufactured for Astute Medical, Inc.
3550 General Atomics Ct.
Building 2
San Diego, CA 92121
USA
MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany
CONTACT INFORMATION:
Phone: [phone]
Phone: [phone]
Email: [e-mail]

ASTUTE140® Meter
©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03
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Table of Contents
Introduction .................. ........................................................................................................ 5
Intended Use ............... ............................................................................................................. 5
Principles of Operation .............................................................................................................. 5
ASTUTE140® Meter Kit Contents ............................................................................................. 6
Materials Required, But Not Provided ....................................................................................... 7
Optional Accessories ................................................................................................................ 7
Contacting Technical Support ..................................... ............................................................. 7
Product Specifications ............................................................................................................... 8
Warnings, Hazards, Precautions and Limitations ..................................................................... 9
Safety Symbols .................................................................................................................... 9
Safety Information ................................................................................................................ 9
FCC Testing …................................................................................................................... 10
Electromagnetic Capability (EMC) ..................................................................................... 10
Limitations .......................................................................................................................... 11
ASTUTE140® Meter Features ................................................................................................. 12
User Types .............................................................................................................................. 15
Operator ............................................................................................................................. 15
Supervisor .......................................................................................................................... 16
Installation .............................................................................................................................. 17
AC Power Supply .................................................................................................................... 17
Installation and Replacement of Batteries .............................................................................. . 18
Installation and Replacement of Paper ................................................................................... 21
Powering On the ASTUTE140® Meter .................................................................................... 22
Supervisor Instructions: Configuration and Settings ............................................................... 23
Adding the First Supervisor User . ..................................................................................... 23
Setting or Changing Time ................................................................................................... 26
Setting or Changing Date ................................................................................................... 27
Setting or Changing the Language .................................................................................... 28
Updating System Software ................................................................................................. 29
Operator Registering Permissions ..................................................................................... 29
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

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Table of Contents (Continued)
ASTUTE140® Meter Operation ........................................................................................ 45
Startup ..................................................................................................................................... 45
Powering On the ASTUTE140® Meter ............................................................................... 45
Logging In ........................................................................................................................... 46
Non-Permanent Settings .................................................................................................... 46
RFID Cards for Device and Lot Registration ........................................................................... 48
ASTUTE140® EQC Device Registration ................................................................................. 48
ASTUTE140® Electronic Quality Control (EQC) ..................................................................... 50
Test Lot Registration ............................................................................................................... 52
Liquid Control Lot Registration ................................................................................................ 54
External Liquid Quality Control (LQC) ..................................................................................... 56
Testing a Patient Sample ........................................................................................................ 60
Review and Management of Test Results .............................................................................. 63
Patient Results ................................................................................................................... 63
LQC Results ....................................................................................................................... 65
EQC Results ...................................................................................................................... 66
Send Results to LIS ........................................................................................................... 68
Shutdown ................................................................................................................................ 68
Care and Maintenance ....................................................................................................... 69
Cleaning and Decontamination ............................................................................................... 69
Replacing the Paper ................................................................................................................ 70
Replacing the Batteries ........................................................................................................... 70
Disposing of the Batteries ....................................................................................................... 70
Disposing of the ASTUTE140® Meter ..................................................................................... 70
Labels and Symbols ................................................................................................................ 71
Troubleshooting Tips ............................................................................................................... 72
Error Messages ....................................................................................................................... 74
End User License Agreement ......................................................................................... 76
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

ASTUTE140® Meter
©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03
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Introduction
Intended Use
The ASTUTE140® 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.
Please read these instructions carefully before using the ASTUTE140® Meter. Please
refer to the assay-specific Product Insert for detailed test information.
Principles of Operation
The ASTUTE140® Meter uses an optical system to measure the fluorescent signal generated
from the test sample in the Test cartridge. After the Test cartridge containing the sample is
inserted into the ASTUTE140® Meter, the meter converts the fluorescent signal from the
immunoassay test into a concentration and provides a test result. Intensity of the fluorescent
signal corresponds to the concentration of the target analyte. If a specific test has more than one
immunoassay, the fluorescent signals from each immunoassay are converted into concentrations,
and these concentrations may be combined into a single test result or reported independently.
Multiple quality control procedures are performed to ensure that the test results are accurate (See
“ASTUTE140® Electronic Quality Control (EQC)” on p. 50 and “External Liquid Quality Control
(LQC)” on p. 56 for details).
Results of the test are displayed on the ASTUTE140® Meter’s LCD screen and may be printed
using the meter’s internal printer, or electronically transmitted to a connected laboratory
information system (LIS).

ASTUTE140® Meter Introduction
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ASTUTE140® Meter Kit Contents
Inspect the shipping container for obvious shipping damage prior to opening. Unpack
the shipping container and inspect the contents for damage. Following are components included
in the ASTUTE140® Meter Kit along with part numbers for items that can be ordered separately:
ASTUTE140® Meter Kit Component Part Number for Re-ordering
ASTUTE140® Meter (1)
Power adapter pack (includes AC power cord,
switching power supply and country (1)
specific adapter)
USB cable (1)
ASTUTE140® Electronic Quality Control
(EQC) Device with RFID card* 400013
ASTUTE140® User Manual (1)
Printer paper rolls (2) 100000
AA batteries (4) (1)
(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.
If the shipping container or its contents are damaged, or if any components are missing, contact
Technical Support (See “Contacting Technical Support” on p. 7 for contact information).
To avoid damaging the ASTUTE140® Meter, DO NOT use any power adapter other
than the one 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 “Installation and Replacement of Batteries” on p. 18 for
further details).

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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. A numeric or alphanumeric barcode reader with a PS2 interface
will work with the ASTUTE140® Meter.
A keyboard with a PS2 interface will work with the ASTUTE140® Meter. Wireless keyboards are
not compatible with the ASTUTE140® Meter.
Contacting Technical Support
For technical support, please contact Technical Support at:
Astute Medical, Inc.!
3550 General Atomics Ct.!
Building 2!
San Diego, CA 92121!USA
Phone: [phone]
Phone: [phone]
Email: [e-mail]

ASTUTE140® Meter Introduction
©Astute Medical, Inc. 2021 PN 300005 Rev G 2021/03/03
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Product Specifications
ASTUTE140® Meter Information
Product Number: 500000
Dimensions: 24 cm deep x 16 cm wide x 12.5 cm high
Weight: 3 lbs.
Power Requirements
AC Power Supply Output Voltage: 6 V DC and 4.16 A
AC Power Supply Input Voltage/
Voltage Range: 100V to 240 V, 47Hz – 63 Hz
Battery Operation: 4 x LR6 — AA batteries
Operating Environment
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

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Warnings, Hazards, Precautions, and Limitations
Safety Symbols
Symbol Definition
Caution. Consult accompanying documents. Indicates a situation that, if not avoided,
could result in damage to the ASTUTE140® Meter or incorrect test results.
Electrical Shock Warning. Indicates a situation that, if not avoided, could result in
electrical shock or bodily harm to the operator or a bystander.
Biological Risks. Indicates a situation that, if not avoided, could result in a health risk
to the operator.
Safety Information
Operate the ASTUTE140® Meter on a level, dry surface.
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.
Use only the AC power adapter supplied with the ASTUTE140® Meter.
Do not immerse the ASTUTE140® Meter in water or any other liquids.
Unplug the AC power adapter from the power supply before cleaning.

ASTUTE140® Meter Introduction
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Handle and dispose of test cartridges and patient specimens in accordance with
federal, state, and local requirements regarding biohazardous materials.
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. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may
cause undesired operation.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful interference to
radio communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his own
expense.
Electromagnetic Capability (EMC)
The electromagnetic environment should be evaluated prior to operation of the Meter.
The Meter generates radio frequency (RF) energy. Do not use this device in close
proximity to sources of strong electromagnetic radiation (e.g., unshielded intentional RF
sources), as these may interfere with proper operation.
Any equipment connected to data ports must be certified to EC61010. If any equipment
is connected that is not recommended it must comply with this standard. For questions
or additional information, please contact Technical Support (See “Contacting Technical
Support” on p. 7 for contact information).