ASTUTE Astute140 Meter User manual

Astute140TMMeterPN:300005SRev:B2012AstuteMedical,Inc.2012/03/17
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ASTUTE140TM METER
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User Manual

Astute140
TM
MeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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For performance evaluation only.
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:
[email protected]
Phone: [phone]
Fax: [phone]
[Add 800 number]
[Add international number]

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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TableofContents
INTRODUCTION......................................................................................................................................................5
INTENDEDUSE........................................................................................................................................................................5
PRINCIPLESOFOPERATION...................................................................................................................................................5
METERKITCOMPONENTS.....................................................................................................................................................6
MATERIALSNEEDEDBUTNOTPROVIDED.........................................................................................................................7
OPTIONALACCESSORIES........................................................................................................................................................7
CONTACTINGASTUTEMEDICAL,INC.(TECHNICALSUPPORT)......................................................................................7
PRODUCTSPECIFICATIONS....................................................................................................................................................7
WARNINGS,HAZARDS,PRECAUTIONS,ANDLIMITATIONS..............................................................................................8
SafetySymbols..........................................................................................................................................................................8
SafetyInformation..................................................................................................................................................................9
Limitations...............................................................................................................................................................................10
METERFEATURES.................................................................................................................................................................11
USERTYPES...........................................................................................................................................................................13
Operator....................................................................................................................................................................................13
Supervisor................................................................................................................................................................................14
INSTALLATION.....................................................................................................................................................14
ACPOWERSUPPLY...............................................................................................................................................................14
INSTALLATIONANDREPLACEMENTOFBATTERIES........................................................................................................15
INSTALLINGORCHANGINGTHEPAPER..............................................................................................................................16
POWERINGONTHEMETER.................................................................................................................................................17
SUPERVISORINSTRUCTIONS:CONFIGURATIONANDSETTINGS....................................................................................18
AddingtheFirstSupervisorUser...................................................................................................................................18
SetorchangeTime...............................................................................................................................................................20
SetorChangeDate..............................................................................................................................................................21
SetorChangetheLanguage............................................................................................................................................22
UpdatingSystemSoftware...............................................................................................................................................23
UpdateMeterLanguages..................................................................................................................................................23
METEROPERATION...........................................................................................................................................23
STARTUP.................................................................................................................................................................................23
PowerontheMeter..............................................................................................................................................................23
Login..........................................................................................................................................................................................24
RFIDCARDSFORDEVICEANDLOTREGISTRATION.......................................................................................................24
EQCDEVICEREGISTRATION...............................................................................................................................................24
ELECTRONICQUALITYCONTROL(EQC)..........................................................................................................................26
LIQUIDCONTROLLOTREGISTRATION..............................................................................................................................28
EXTERNALLIQUIDQUALITYCONTROL(LQC)................................................................................................................30
TESTLOTREGISTRATION....................................................................................................................................................32
TESTINGAPATIENTSAMPLE..............................................................................................................................................34
REVIEWANDMANAGETESTRESULTS..............................................................................................................................37
PatientResults.......................................................................................................................................................................37
LQCResults..............................................................................................................................................................................38
EQCResults..............................................................................................................................................................................40
SendResultstoLIS...............................................................................................................................................................41
SHUTDOWN............................................................................................................................................................................42
CAREANDMAINTENANCE...............................................................................................................................42

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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CLEANINGANDDECONTAMINATION.................................................................................................................................42
CHANGINGTHEPAPER..........................................................................................................................................................43
CHANGINGTHEBATTERIES.................................................................................................................................................43
DISPOSINGOFTHEBATTERIES............................................................................................................................................43
DISPOSINGOFTHEMETER..................................................................................................................................................43
LABELSANDSYMBOLS.........................................................................................................................................................43
TROUBLESHOOTINGTIPS...................................................................................................................................................45
ERRORMESSAGES.................................................................................................................................................................47
ENDUSERLICENSEAGREEMENT...................................................................................................................48
GLOSSARYOFTERMS(LISTEDALPHABETICALLY)................................................................................50
APPENDIX..............................................................................................................................................................53
MAINMENUSTRUCTURE.....................................................................................................................................................54
REVIEWDATAMENUSTRUCTURE.....................................................................................................................................55
OPERATORMENUSTRUCTURE...........................................................................................................................................56
SUPERVISORMENUSTRUCTURE........................................................................................................................................57
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Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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Introduction
IntendedUse
The Astute140TM 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 is used in conjunction with a test cartridge to measure the
concentration of a target analyte (such as a protein marker) in a sample.
Please refer to the assay-specific Product Insert for detailed test information.
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 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 “Electronic Quality Control
(EQC)”, p. XX and “External Liquid Quality Control (LQC)”, p. XX for details).
Results of the test are displayed on the Meter’s LCD screen, and may be printed using
the Meter’s internal printer or electronically transmitted to a laboratory information
system (LIS), if connected.

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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MeterKitComponents
Inspect the shipping container for obvious shipping damage prior to opening. Unpack
the shipping container and inspect the contents for damage. The following components
are included in the Astute140 Meter Kit (For re-ordering information, visit
www.astutemedical.com or contact your Astute Medical, Inc. sales representative):
Astute140 Meter Kit component Part number for re-ordering
Astute 140 Meter
AC power adapter pack (includes
AC power cord, switching power
supply, and country specific
adapter)
100007
USB cord 100002
Astute140
TM
Electronic Quality
Control (EQC) Device
400001
Astute140
TM
Electronic Quality
Control (EQC) RFID card
400001
Astute140 User Manual 300005
Quick Start Guide 300007
Instructional DVD 300006
Printer paper rolls (2) 100000
AA batteries (4)
If the shipping container or its contents are damaged, or if any components are missing,
contact Astute Medical, Inc. Technical Support (For contact information, see “Contacting
Astute Medical, Inc.” o p. X ).
NOTES:
DO NOT use any other power adapter with the Astute140 Meter or you may damage
the Meter.

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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Batteries are not intended to be used as the main power source for operation of the
Astute140 Meter and should only be used as a backup power source if there is no
electrical output available. See “Batteries”, p. X for further details.
MaterialsNeededbutNotProvided
The following materials are required for testing patient samples and may be purchased
and shipped separately from Astute Medical, Inc:
Test Kits
Liquid Control Set
For a list of approved tests and corresponding liquid controls for use with the
Astute140 Meter, go to www.astutemedical.com or consult your Astute Medical, Inc.
sales representative.
OptionalAccessories
Optional accessories that may be used with the Meter include an external barcode
reader and an external keyboard. External barcode readers and external keyboards are
not available from Astute Medical, Inc. and must be purchased elsewhere.
ContactingAstuteMedical,Inc.(TechnicalSupport)
For Technical support, please contact Astute Medical, Inc. at Astute Medical, Inc.,
3550 General Atomics Ct., Building 2, San Diego, CA 92121, USA.
ProductSpecifications
Astute140
TM
Meter Information
Product Number:
Dimensions:
Weight:
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

Astute140
TM
MeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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Operating Environment
Altitude:
Temperature: +15C – 30C
Humidity: 30% - 80% rH, non-condensing at 15C
operating temperature
15% - 80%, rH, non-condensing at
30C
Storage Environment
Temperature: -20C to +60C
Humidity: 20% - 85% rH, non-condensing
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Warnings,Hazards,Precautions,andLimitations
SafetySymbols
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Astute140
TM
MeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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9
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.
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.

Astute140
TM
MeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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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 Astute Medical, Inc. Technical
Support (for contact information, see “Contacting Astute Medical, Inc.” on p. X).
Limitations
The Astute140 Meter does not contain a “batch mode” function. The Meter times the
incubation period for the test, and only one test can be run at a time; therefore, each
test cartridge must be run immediately after being inoculated with the patient sample or
liquid control. The time delay in testing that would result from inoculating more than one
cartridge at a time may lead to inaccurate test results.