ASTUTE Astute140 Meter User manual

Astute140TMMeterPN:300005SRev:B2012AstuteMedical,Inc.2012/03/17
[Company Logo]
ASTUTE140TM METER
[PHOTO HERE]
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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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.

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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MeterFeatures
[Photo of front of Meter here with labels]
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 Button 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 cartridge into
the Meter
13 Battery cover Covers the battery compartment
[Photo of back of Meter here with labels]

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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1 PS/2 Port Used to connect the optional external
barcode reader and/or keyboard to the
Meter
2 Ethernet Port Used to connect the Meter to a LIS or
to a computer to download software
3 AC Power Adapter Port Used to connect the AC power adapter
to the Meter
4 USB Port Used to connect the Meter to a
computer to download new software
versions or manage the meter
5 On/Off Switch Used to power the Meter on and off

[Photo of bottom of Meter here with labels]
1 Battery Cover Covers the battery compartment
2 Serial Number Unique number used to identify the Meter
3 In-Vitro Diagnostic device labels and
symbols
Regulatory labels and symbols used to
provide information about the Meter and its
proper use (See “Labels and Symbols”, p.
XX, for definitions)

[Photo of Main Menu screen here]
All Meter functions are grouped under six icons found on the Main Menu (for menu
structures, see the Appendix):
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

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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lots, liquid control lots, and EQC devices;
temporarily change non-permanent
settings, and view error logs
6 Supervisor Select to set/change general Meter
settings, manage users, obtain Meter
information, or view error logs
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UserTypes
There are two types of users defined for the 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:
Power the Meter on/off
Run electronic quality control (EQC)
Run liquid quality control (LQC)
Test patient samples
Review and print data (Patient test results, QC test results)
View error log
Operators may perform the following functions only if a Supervisor grants permission
in the default settings:
Manage (register/delete/print) test lots
Manage (register/delete/print) LQC lots
Manage (register/delete/print) EQC devices
The Operator may change the following settings temporarily while using the 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.
Date format
Time format
Language

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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Beeper (On/Off)
Supervisor
Users logged in as Supervisors may perform all of the Operator functions and the
following additional functions:
Set or change all default system settings (Time, Date, Language, Log On Setup,
registering lot/control permissions, QC settings)
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 Meter information (hardware/firmware/bootware/serial number/IP address)
Installation
ACPowerSupply
The Meter is generally 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 “Batteries” on p. X.).
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, and connect them as shown:
[Show picture depicting connection of the 3 cords]
2. Insert the end of the country-specific adapter into a power source
[Show picture depicting connection of the country-specific adapter into a power
source]

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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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 Meter.
[Show picture depicting insertion of the switching power adapter into the port on
the back of the Meter]
NOTE: To avoid damage to the 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 Meter prior to
unplugging it from the electrical power source.
InstallationandReplacementofBatteries
The Meter is generally meant to be powered by plugging the AC power adapter into an
electrical power source (see “AC Power Adapter, p. X); however, 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 a electricity failure or if the Meter
must be operated in a location where there is no electric output).
When using alkaline or Li batteries under a temperature operating range of 20o to 25oC,
the Meter will allow approximately 15 user tests to be performed before requiring battery
replacement.
The Meter includes a low battery indicator.
[Insert picture depicting the low battery indicator unlit]
The batteries should be changed when the low battery indicator is lit.
[Insert picture depicting the low battery indicator when lit]
When the low battery indicator is lit, the Meter can run at least 3 additional tests within 1
hour under the same operating conditions before the batteries will need to be replaced.

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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To install or replace four AA batteries into the Meter or change the batteries:
1. Press the Eject Button to the left of the LCD display to open the Meter drawer
and ensure there is not a cartridge in the Meter.
2. Power off the Meter.
3. Gently turn the Meter over so the bottom is facing up and place it on a flat
surface.
[Insert image depicting Meter turned upside down, and placed on a flat surface]
4. Open the battery cover by pressing your thumb on the center of the battery cover and
sliding it in the direction shown below:
[Insert image showing bottom of Meter with thumb pressing on and sliding battery cover
to the left]
5. If replacing the batteries, remove the old batteries and properly discard them (see
“Disposing of the batteries”, p. XX).
6. Insert 4 AA 1.5 volt batteries, making sure that the ends of the batteries facing up
correspond to the + and – signs diagrammed in the battery compartment,
[Insert diagram of the battery compartment with symbols visible]
7. Replace the battery cover by sliding it back into position as shown until it snaps firmly
in place.
8. Turn the Meter right side up.
InstallingorChangingthePaper
To install or change the internal printer paper, perform the following steps:
1. Remove the printer cover by pulling up on the blue handle on top of the cover.
2. If changing the paper, remove the empty spool and any unused paper.

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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3. Place the paper roll into the holder with the end of the paper coming from under the
roll toward the Meter display.
[INSERT PHOTO DEPICTING STEP 3]
4. Holding the end of the paper, replace the printer cover as shown below until it snaps
into place.
[insert photo depicting step 4]
5. To feed the paper further out the top of the printer press [paper button].
PoweringOntheMeter
To power on the Meter, locate the power switch on the back of the Meter and toggle it
upwards, holding it in position until the self-test screen appears.
[Insert screen shot of self-test screen]
When all systems pass, the Log In screen will then automatically appear, indicating that
the Meter is ready for use.
[Insert screen shot of Log In screen]
If the self-test fails, an error message will be displayed. Press the right soft key to
select OK and close the error message, and then restart the Meter by turning it off and
back on again (to power off the Meter, toggle the power switch upwards and it should
immediately shut down). If after restarting the Meter the self-test fails again, contact
Asute Medical, Inc. Technical Support (See “Contacting Astute Medical, Inc.” on p. X).

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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SupervisorInstructions:ConfigurationandSettings
AddingtheFirstSupervisorUser
The first Supervisor user must be added to the Meter before any default settings may be
set or changed. The Meter comes from the factory with a default Supervisor login ID
(1234) that will allow the first Supervisor user to log in and create a user profile. Once
the new profile is created, the user must log out of the system and log back in with the
new user information before performing any additional functions.
Perform the following steps to add the first supervisor user:
1. After powering on the Meter, the Log In screen will be displayed after a brief self
test (see “Powering on the Meter” on p. X for details.)
[Insert screen shot of Log In screen]
2. When the Log In screen is displayed, User ID is highlighted. Enter 1234 using
the numeric keypad or an external keyboard, if connected.
3. After entering your user ID, use the [down arrow navigation key] key to highlight
the Password field.
4. Use the numeric keypad or an external keyboard, if connected, to enter 1234.
Press the right soft key to accept all entries.
5. After logging in, the Main Menu will be displayed. Use the navigation keys to
highlight the Supervisor Menu icon. Press the right soft key to display the
Supervisor Menu.
[Insert screen shot of Main Menu with Supervisor icon highlighted]
6. When the Supervisor Menu is displayed, General Meter Settings is highlighted.
Use the [down arrow navigation key] key to highlight Manage Users and press
the right soft key.

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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7. The screen should read Existing User List across the top; however, no users
should be listed. Press the right soft key to display the Options pop-up menu.
[Insert screen shot of #7]
8. When the Options pop-up menu is displayed, use the [down arrow navigation
key] key to highlight Add User and press the right soft key to display the Create
New User screen.
9. When the Create New User screen is displayed, Mode will be highlighted. Use
the [right and left arrow navigation keys] keys to toggle between operator and
Supervisor. Select Supervisor.
10.After selecting Supervisor, use the down arrow navigation key to highlight Name.
Use the numeric keypad or an external keyboard, if connected, to enter a user
name.
11.Use the down arrow navigation key to highlight ID. Use the numeric keypad or
an external keyboard, to enter a numeric ID.
12.Once a numeric ID is entered, use the down arrow navigation key to highlight
Password. Use the numeric keypad or an external keyboard, if connected, to
enter a password.
13.After entering a password, use the [down arrow navigation key] key to re-enter
the password.
14.Confirm that the correct information is displayed. To make changes to the
entries, use the [up and down arrow navigation keys] keys to highlight the field to
be changed. Use the [backspace key] key to delete the incorrect entry, and then
use the numeric keypad or an external keyboard, if connected, to change the
entries. To clear all entries on the screen, press the left soft key. Once the
correct entries have been made, press the right soft key to accept all entries.
15.After accepting the new user information entered, the Existing User List screen
will again be displayed. The user information just created should now appear in
the list, including the user ID, Name, and Mode (Supervisor or Operator).
16.Press the left soft key to return to the main Supervisor menu.

Astute140TMMeterPN:300005SRev:BAstuteMedical,Inc.20122012/03/20 
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17.Press the left soft key to return to the Main Menu.
18.Press the left soft key to log out of the system.
19.After logging out, the Log In screen will appear and User ID will be highlighted.
Enter your new user ID using the numeric keypad or an external keyboard, if
connected.
20.After entering your user ID, use the [down arrow navigation key] key to highlight
the Password field.
21.Use the numeric keypad or an external keyboard, if connected, to enter your new
password.
22.Confirm that the correct log in information is displayed. To make changes to the
entries, use the [up and down arrow navigation keys] keys to highlight the field to
be changed. Use the [backspace key] key to delete the incorrect entry, and then
use the numeric keypad or an external keyboard, if connected, to change the
entries. Press the right soft key to accept all entries.
SetorChangeTime
The Supervisor can set or change the time by performing the following steps:
1. Press the [picture of menu button] key to display the Main Menu.
2. Use the navigation keys to highlight the Supervisor Menu icon.
[Insert screen shot of Main Menu with Supervisor Icon highlighted]
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 Meter Settings screen.
5. When the General Meter Settings screen is displayed, Default Settings is
highlighted. Press the right soft key to display the Default Settings screen.
6. When the Default Settings screen is displayed, Time & Time Format is
highlighted. Press the right soft key to display the Time & Time Format screen.
7. When the Time & Time Format screen is displayed, Time Format is highlighted.
Use the [left and right arrow navigation keys] to choose either a 12- or 24-hour
time format for display on the screen and printouts.