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
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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

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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).

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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]

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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.

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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).

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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. The time delay in testing that would result from loading more than one cartridge at a time
may lead to inaccurate test results.

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ASTUTE140® Meter Features
Feature Function
1 Printer Cover Covers the printer
2 LCD Display User interface—displays screens for navigating, entering data,
and reviewing data
3 Paper Feed Key Advances the paper roll
4 Eject Key Opens the drawer
5 Main Menu Key Used to return to the Main Menu
6 Navigation Keys Used to navigate up, down, left, and right within menu screens
7 Left Soft Key Used to select the menu option displayed above the key
8 Right Soft Key Used to select the menu option displayed above the key
9 Numeric Keypad Used to enter numerical values into menus and screens
10 Decimal Point Used to add decimal points to numerical values
11 Backspace Key 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
Figure 1.
ASTUTE140® Meter

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ASTUTE140® Meter Features (Continued)
Feature Function
1 PS/2 Port Used to connect the optional external barcode reader or
keyboard to the ASTUTE140® Meter
2 Ethernet Port Used to connect the ASTUTE140® Meter to an LIS or to a
computer network to download software
3 AC Power Adapter Port Used to connect the AC power adapter to the ASTUTE140®
Meter
4 USB Port Used to connect the ASTUTE140® Meter to a computer to
download new software
5 On/Off Switch Used to power the ASTUTE140® Meter on and off
Figure 2.
ASTUTE140®
Meter – back

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ASTUTE140® Meter Features (Continued)
Feature Function
1 Battery Cover Covers the battery compartment
2 Serial Number Unique number used to identify the ASTUTE140® Meter
3 In-Vitro Diagnostic device
labels and symbols
Regulatory labels and symbols used to provide information about
the ASTUTE140® Meter and its proper use (See “Labels and
Symbols” on p. 71 for definitions)
Figure 3.
ASTUTE140® Meter
– bottom

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ASTUTE140® Meter Features (Continued)
All ASTUTE140® Meter functions are grouped under six icons found on the Main Menu (For
menu structures, see the Appendix):
Feature Function
1 Run Patient Select to run patient tests
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 lots, liquid control lots,
and EQC devices; temporarily change non-permanent settings,
and view error logs
6 Supervisor Select to set/change general settings, manage users, obtain
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:
g Power the ASTUTE140® Meter on/off
Figure 4.
Main Menu screen

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g Run electronic quality control (EQC)
g Run liquid quality control (LQC)
g Test patient samples
g Review and print data (Patient test results, QC test results)
g View error log
Operators may perform the following functions only if a Supervisor grants permission in the
default settings:
g Manage (register/delete/print) test lots
g Manage (register/delete/print) LQC lots
g 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:
g Date format
g Time format
g Language
g Beeper (On/Off)
Supervisor
Users logged in as Supervisors may perform all of the Operator functions and the following
additional functions:
g Set or change all default system settings (Time, Date, Language, Log On Setup, registering
lot/control permissions, QC settings)
g Set or change LIS settings
g Set PC Mode (On/Off)
g Set or change network settings
g Set or change print headers
g Manage Users (change/add/delete)
g View ASTUTE140® Meter information (hardware/firmware/bootware/serial number/IP
address)

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Installation
AC Power Supply
The ASTUTE140® Meter is meant to be powered by plugging the AC power adapter into a power
source; however, power may be supplied temporarily by four AA batteries when an electrical
power source is unavailable (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. Locate the AC power adapter pack containing the AC power cord, the switching power
supply, and the country-specific adapter, then connect them as shown:
2. Insert the end of the country-specific adapter into a power source.
Figure 5.
Connecting
power cords

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3. Insert the cylindrical end of the switching power adapter into the AC power adapter port on
the back of the ASTUTE140® Meter.
To avoid damage to the ASTUTE140® Meter from a potential power surge, always plug
the AC power adapter into the electrical power source prior to connecting it to the
meter. When removing power, disconnect the AC power adapter from the
ASTUTE140® Meter prior to unplugging it from the electrical power source.
Installation and Replacement of Batteries
The ASTUTE140® Meter is meant to be powered by plugging the AC power adapter into an
electrical power source (See “AC Power Supply” on p. 17).
Power may be supplied for a limited period of time by four AA batteries when an electrical power
source is unavailable (for example, in the event of electricity failure or if the meter must be
operated in a location where there is no electric output). 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 20o to 25o C, the
ASTUTE140® Meter will allow approximately 10 user tests to be performed before requiring
battery replacement.
Figure 6.
Connecting AC
power adapter to
ASTUTE140® Meter

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The ASTUTE140® Meter includes a battery strength indicator.
The batteries should be changed when the battery strength indicator is displayed as 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.
To install four AA batteries into the ASTUTE140® Meter or to change the batteries:
1. Press the key to the left of the LCD display to open the ASTUTE140® Meter drawer
and ensure there is not a cartridge in the meter.
2. Power off the ASTUTE140® Meter.
Figure 7.
Battery strength
indicator – full
Figure 8.
Battery strength
indicator – empty
and blinking

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3. Gently turn the ASTUTE140® Meter over so the bottom is facing up and place it on a flat
surface.
4. Open the battery cover by pressing your thumb firmly on the center of the battery cover and
sliding it in the direction shown below:
5. If replacing the batteries, remove the old batteries and properly discard them (See
“Disposing of the Batteries” on p. 70).
Figure 9.
ASTUTE140®
Meter – bottom
facing up
Figure 10.
Removing battery
cover