LRE Medical Esterline 8051000 Apex Reader User Manual Apex User s Guide 4 6 10 FCC

LRE Medical GmbH Esterline Corporation Apex Reader Apex User s Guide 4 6 10 FCC

USer Manual

FOR INVESTIGATIONAL USE ONLYTo be used by qualified investigators only.The performance characteristics of this device have not been established. Part Number: 80 510 00Revision CINSTRUMENT DE RECHERCHÉRéservé uniquement á l’usage de chercheurs compétentsLes spécifications de rendement de l’instrument n’ont pas été éstablies.Apex ReaderUser’s Guide
Apex Reader User’s Guide2CopyrightThis document discloses subject matter in which AspenBio Pharma, Inc. has certain proprietary rights. Neither receipt nor possession of this document confers or transfers any rights to reproduce, store in a retrieval system, transmit or translate in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from AspenBio Pharma.The information contained in this User’s Guide is subject to change. Illustrations, including software screen illustrations, are representative, and may not reflect the most recently released updates.Copyright © 2010 AspenBio Pharma, Inc. All rights reserved.DistributorThe is distributed by:AspenBio Pharma, Inc.1585 South Perry StreetCastle Rock, CO 80104www.aspenbiopharma.comT: (303) 794-2000F: (303) 798-8332TrademarksAspenBio Pharma® is a registered trademark of AspenBio Pharma, Inc.Apex Reader
3ContentsIntroduction ...........................................................................................5Product Overview .............................................................................5Kit Components ........................................................................6Reader Features........................................................................7Understanding Labelling Symbols ...........................................9Understanding Screens and Menus.........................................9Product Specifications ...........................................................18Safety Symbols ...............................................................................19Safety Information...........................................................................19How To Use This Guide ..................................................................21Setup .....................................................................................................23Supplying Power to the Reader .....................................................23Turning On and Configuring the Reader........................................24Turning On the Reader............................................................24Setting the Date and Time......................................................25Installing the Paper .................................................................27Adding the First Supervisor User ...........................................29Connecting to the LIS.....................................................................33Setting Up the Network Connection ......................................33Providing LIS Settings ............................................................36Changing Reader Settings .............................................................38Changing the Language..........................................................39Changing Patient ID Settings .................................................40Changing the Print Setting .....................................................43Changing Security and Power Saving Settings.....................44Managing Users ..............................................................................47Adding a User..........................................................................47Changing User Information.....................................................51Enabling or Disabling a User ..................................................55Deleting a User........................................................................57Daily Operations ................................................................................61Startup.............................................................................................61Turning On the Reader............................................................61Logging In................................................................................62Running Quality Control Checks ............................................63Testing a Patient Sample................................................................68Managing Patient Results ..............................................................72Viewing Detailed Test Results................................................72Sending Patient Results .........................................................75Printing Patient Results ..........................................................76Viewing a Result Stored on a Test Cartridge.........................78Daily Shutdown ...............................................................................81
Apex Reader User’s Guide4Export / Import Features ................................................................ 83Exporting Stored Test Results....................................................... 84Exporting Raw Test Data ............................................................... 86Importing and Exporting Users...................................................... 87Exporting a User..................................................................... 87Exporting All Users................................................................. 89Importing a User ..................................................................... 91Importing All Users ................................................................. 93Other Features ................................................................................... 97Reviewing Reader Information....................................................... 97Checking the Software Version.............................................. 97Reviewing the Supervisor History.......................................... 99Reviewing Global Settings ................................................... 101Reviewing Internal Check Results ....................................... 103Checking Ambient Temperature.................................................. 105Deleting Stored Test Results ....................................................... 106Resetting the Reader to Default Settings.................................... 109Using the Barcode Reader Accessory ........................................ 110Care & Maintenance....................................................................... 111Maintaining the Reader ................................................................ 111Cleaning the Reader............................................................. 111Changing the Paper.............................................................. 111Replacing the Batteries........................................................ 114Changing the Date and Time ............................................... 115Updating Reader Languages ............................................... 118Upgrading the Reader Software .......................................... 121Troubleshooting............................................................................ 123Troubleshooting Tips............................................................ 123Understanding Error Messages ........................................... 124Quality Assurance......................................................................... 126Returning the Reader ................................................................... 126Disposing of the Reader............................................................... 126Glossary ............................................................................................. 127
5IntroductionProduct OverviewThe is a portable fluorescence instrument used to measure the results of tests manufactured by . The reader is designed for use in a laboratory setting.The reader uses a Class 1 laser as a light source. Light from the laser hits a test cartridge that has been inserted in the reader. This causes the fluorescent dye in the test cartridge to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.Each test cartridge includes an RFID tag that identifies relevant parameters for evaluating the test results. These parameters include:■Test name■Calibration coefficients■Expiry date■Sample/Reagent Assembly (SRA) typeAssay specific information is stored on the RFID tag on the test cartridge, so it is not necessary to upload any test-related information prior to running a test. Patient information can be entered in the reader manually or using the optional barcode reader accessory.After a test sample (plasma) from a patient is added to the test cartridge, the cartridge is inserted in the reader’s drawer with the sample application area facing toward the user. The reader’s internal scanner reads the RFID tag on the test cartridge and automatically processes the test. The reader measures how much of a particular protein marker is present based on pre-programmed standards, and Apex Reader and Test CartridgeApex Reader
Apex Reader User’s Guide6interprets and reports the test result. Test results can be printed, sent to the LIS, or exported to an SD card.Kit ComponentsThe following components are included in the reader kit:■Reader■Universal Power Transformer■Country Extension Cord■AA Batteries (4)■System Check Cassette■External Barcode Reader (Optional)■Thermal Paper Rolls (4)■1 GB SD Card■User’s Guide■Warranty Card■Quick Start CardKit Components
Introduction7Reader FeaturesReader—Front ViewFeature Description1Printer Cover Covers the printer.2Display Shows screens for navigating, entering data, and reviewing data.3Eject button Used to eject the drawer.4Paper Feed Button Used to advance the paper roll.5Main Menu Button Used to return to the Main Menu screen.6Left Soft Key Used to select the option displayed above the key on the display.7Navigation Buttons Used to navigate within menus and reader screens.8Right Soft Key Used to select the option displayed above the key on the display.9Numeric Keypad Used to enter numbers and decimal points.10 Delete Button Used to delete the character to the left of the cursor.11 Battery Cover Covers the battery compartment.12 Drawer Used for inserting prepared test cartridges and the system check cassette in the reader.
Apex Reader User’s Guide8Reader—Back ViewFeature Description1PS/2 Port Used to connect the optional barcode reader accessory to the reader.2Ethernet Port Used to connect the reader to the LIS network.3AC Power Port Used to connect the AC power adapter to the reader.4SD Card Slot Used for importing and exporting information via the SD card.5On/Off Switch Used to turn the reader on and off.
Introduction9Understanding Labeling SymbolsConsult the following table to understand the symbols located on the bottom of the reader:Understanding Screens and MenusThe supervisor menu structure is different from the operator menu structure. Refer to the appropriate section below for information about the menu structure for your user mode.Each of the options available on the supervisor Main Menu screen are described below.This symbol... indicates...The device meets the requirements of the directive set forth by the European Commission for in vitro diagnostic medical devices.The user should consult the instructions for use for proper operation of the device.The product is designed for use as an in vitro diagnostic medical device.The catalog number for the device.The upper and lower relative humidity limits for operation of the device.The upper and lower temperature limits for operation of the device.The device requires safe disposal in conformance with the WEEE Directive.The polarity of the power supply tip is positive.The manufacturer of the device.Supervisor Main Menu Screen
Apex Reader User’s Guide10■Import / ExportWhen you select Import / Export from the supervisor Main Menu, a menu with the following options appears:– Import / Export UserSelect this option to export user records to or import user records from a compatible SD card. See Importing and Exporting Users on page87 for more information.– Export Result ListSelect this option to export test results stored on the reader to a compatible SD card. See Exporting Stored Test Results on page84 for more information.– Export Raw Data ScanSelect this option to export the last 10 raw data scans stored on the reader to an SD card. See Exporting Raw Test Data on page86 for more information.– Import LanguageSelect this option to update the languages available in the reader. See Updating Reader Languages on page118 for more information.– Upgrade SoftwareSelect this option to upgrade the reader software. See Upgrading the Reader Software on page121 for more information.Import / Export Screen
Introduction11■SettingsWhen you select Settings from the supervisor Main Menu, a menu with the following options appears:– Set Date and TimeSelect this option to change the reader’s date and/or time. See Changing the Date and Time on page115 for more information.– Select LanguageSelect this option to change the reader’s language setting. See Changing the Language on page39 for more information.– Read TemperatureSelect this option to check the ambient temperature detected by the reader. See Checking Ambient Temperature on page105 for more information.– LIS Reviewer SetupSelect this option to configure the LIS reviewer settings for the reader. See Providing LIS Settings on page36 for more information.– Set Login / LogoutSelect this option to change the logout time, power off time, or auto-login setting. See Changing Security and Power Saving Settings on page44 for more information.– Network SetupSelect this option to set up the network connection. See Setting Up the Network Connection on page33 for more information.– Printing SetupSelect this option to change the print setting. See Changing the Print Setting on page43 for more information.Supervisor Settings Screen
Apex Reader User’s Guide12– Set Patient IDSelect this option to change patient ID settings. See Changing Patient ID Settings on page40 for more information.– Device InfoSelect this option to review software version information, reader settings, supervisor history, and internal check results. See Reviewing Reader Information on page97 for more information.– Delete ResultsSelect this option to delete test results stored in the reader’s memory. See Deleting Stored Test Results on page106 for more information.– Reset to DefaultSelect this option to reset the reader to its default settings. See Resetting the Reader to Default Settings on page109 for more information.■User AdministrationWhen you select User Administration from the supervisor Main Menu, a menu with the following options appears:– Organize existing IDsSelect this option to modify or delete existing user records. See Managing Users on page47 for more information.– Create new IDSelect this option to add a new user. See Adding a User on page47 for more information.User Administration Screen
Introduction13■Check ReaderWhen you select Check Reader from the supervisor Main Menu, a menu with the following options appears:– Internal Hard StandardSelect this option to run an internal QC check on the reader. See Running Quality Control Checks on page63 for more information.– External ControlSelect this option to run an external QC check using the system check cassette provided with the reader. See Running Quality Control Checks on page63 for more information.■Change to OperatorSelect this option to access the operator Main Menu screen. From this screen, you can run a test and view, send, and print patient results.Supervisor Check Reader Screen
Apex Reader User’s Guide14Each of the options available on the operator Main Menu screen are described below.■Run TestSelect this option to test a patient sample. See Testing a Patient Sample on page68 for more information.■Result HistoryWhen you select Result History from the operator Main Menu, a menu with the following options appears:– Organize ResultsSelect this option to view, send, and print patient results stored in the reader’s memory. See Managing Patient Results on page72 for more information.– Read CartridgeSelect this option to view an individual result stored on a test cartridge. See Viewing a Result Stored on a Test Cartridge on page78 for more information.Operator Main Menu ScreenResult History Screen
Introduction15■MaintenanceWhen you select Maintenance from the operator Main Menu, a menu with the following options appears:– SettingsSelect this option to review software version information, reader settings, and supervisor history. See Reviewing Reader Information on page97 for more information.– Check ReaderSelect this option to run an internal QC check on the reader or to run an external QC check using the system check cassette provided with the reader. See Running Quality Control Checks on page63 for more information.– Change to SupervisorSupervisor users can select this option to access the supervisor Main Menu screen. From this screen, you can import and export information, change reader settings, and manage user records.Maintenance Screen
Apex Reader User’s Guide16Each screen is divided into three areas: the header bar, the content area, and the soft keys.The information displayed in each area is described below.■Header BarThe header bar is the dark blue area at the top of the reader screen that provides the following information:– The icon shown at the far left of the header bar indicates whether the user is logged in as a supervisor or an operator.– The number shown next to the user icon is the user ID for the current user. If the auto-login setting is enabled, the header bar shows “Auto-Login” instead of the user ID.– The current date and time are shown to the right of the user information.– The icon shown at the far right of the screen indicates whether the reader is using AC power or battery power.
Introduction17The following table identifies the icons that appear in the header bar.■Content AreaThe content area is the light blue area occupying the majority of the reader screen. This area displays menu options, settings, and data.When you are logged in as a supervisor, the currently selected option is indicated by a yellow bar with black text. When you are logged in as an operator, the currently selected option is indicated by a blue bar with white text as shown below.■Soft Key SelectionsThe soft key selections are the dark blue areas with white text displayed at the lower left and lower right of the reader screen. Some screens have two soft key selections, while other screens have only one option.To use a soft key selection, press the soft key below the desired option. Supervisor Main Menu Screen Operator Main Menu ScreenThis icon... indicates that...The user is logged in as a supervisor.The user is logged in as an operator.The reader is using battery power and the batteries are fully charged. The battery icon is gradually filled with white as the batteries are discharged.The AC power adapter is being used to power the reader.
Apex Reader User’s Guide18Product SpecificationsAG: CONFIRM ALL AND PROVIDE ANY ADDITIONAL SPECS AND STANDARDS.Product InformationModel Number: TBDDimensions: TBDWeight: TBDPower RequirementsAC Operation: 6 VDC at 4.16 ABattery Operation: 4 AA / LR6 cells(Nominal voltage > 1.5 VDC)Operating EnvironmentAltitude: 0 to 2000 mTemperature: 15°C to 30°CHumidity: 30% to 80% noncondensingDegree of Pollution: 2Storage EnvironmentTemperature: – 20°C to 55°C for 24 hoursHumidity: 25% to 85% noncondensingExternal Barcode Reader (Optional)Connector: PS/2Power: 5 VDC at < 300 mACodes Supported: Any 1D code 20 characters or less in lengthModel: Dialogic Touch 65 or equivalentExternal Keyboard (Optional)Connector: PS/2Network Connectivity (Optional)Connector: RJ45Communications: 10(100)BASE-T using TCP/IPData Protocol: POCT 1-A2Applicable StandardsEU: TBDRest of World: TBD
Introduction19Safety SymbolsThe following symbols are used in this user’s guide:Safety InformationReview the safety information below before using the reader. AG: CONFIRM ALL.This icon... indicates a...BIOHAZARD WARNING: A situation, which if not avoided, could result in a health risk to the user.ELECTRICAL SHOCK WARNING: A situation, which if not avoided, could result in electrical damage to the reader or bodily injury to the user.CAUTION OR WARNING: A situation, which if not avoided, could result in incorrect operation or damage to the reader.CAUTION: Use the reader only in the operating environment specified. For details, see Product Specifications on page18.CAUTION: To ensure proper operating temperature, do not place the reader near radiators, bright sunlight, heat registers, stoves, or other heat-producing equipment.WARNING: Operate the reader using only the power cord and power supply (AC adaptor) provided. Connect the reader to an earth-grounded outlet that meets the product’s power specifications. For details, see Product Specifications on page18.WARNING: The reader is intended for indoor use only. To reduce the risk of electrical shock, always unplug the power supply from the AC power source following use.
Apex Reader User’s Guide20CAUTION: The printout is the formal record of the test result. Print out every test result and make 2 photocopies. Place the printed test results and both photocopies in the patient’s records.CAUTION: Results are stored in the reader memory for temporary backup purposes only and may be overwritten. The reader memory stores results for the last 100 tests run. When memory capacity is reached, the most recent test result automatically overwrites the oldest test result.WARNING: When using the reader, observe universal precautions for safety and laboratory working practices, and follow laboratory operating procedures regarding personal protective equipment (such as lab coats, gloves, and so forth) and safety.WARNING: Handle and dispose of test cartridges in accordance with standard biohazard practices unless otherwise indicated in the relevant package insert.WARNING: Do not remove external panels to access the interior of the reader. The reader contains a UV LED used to read the test cartridges. UV LEDs are not considered to be hazardous when used as intended.
Introduction21How To Use This GuideThe following conventions are used in this manual to help guide you through use of the reader’s features: ■Each screen is referenced by the name that appears at the top of the screen.■Words that appear on the screen (titles, on-screen options and soft key labels) are shown in bold.■Buttons are referenced only by their icon.For example:Use and to make the necessary changes.■To make instructions easy to read, soft keys are referenced only by their label. For example:Press Select to save this setting.
Apex Reader User’s Guide22
23SetupSupplying Power to the ReaderThe reader can be powered by four AA batteries or by the AC power adapter. If you use the AC power adapter, it is recommended to install batteries as a backup to prevent loss of data if the AC power adapter is disconnected from the reader.Perform the following steps to install batteries in the reader:1. Turn the reader over so that the back of the battery cover is visible.2. To remove the battery cover, place your thumb in the middle of the cover and exert slight pressure as you slide it in the direction shown below.3. Insert four size AA 1.5 volt batteries. Be sure that the plus (+) and minus (-) signs on the batteries match the signs embossed in the battery compartment.4. Replace the battery cover by positioning it at the edge of the battery compartment as shown and sliding it into position.5. When you have completed battery installation and replaced the battery cover, turn the reader right side up.Installing the BatteriesNOTE: If the reader does not power on after replacing the batteries, verify that the batteries are lined up according to the symbols in the battery compartment.
Apex Reader User’s Guide24Perform the following steps to use the AC power adapter:1. Connect the AC power adapter to the reader by inserting the cylindrical end of the adapter into the round hole in the back of the reader.2. Connect the other end of the AC power adapter to a power source.Turning On and Configuring the ReaderTurning On the ReaderThe on/off switch is located on the back of the reader. To turn on the reader, push the on/off switch up until the Initializing screen appears, then release it. The reader displays a splash screen during startup, then displays the Set Date screen. You must set the date and time before running any patient samples.Connecting the AC Power AdapterNOTE: If necessary, use the extension cord included with the reader to convert to a different type of electrical outlet.Set Date ScreenIMPORTANT: Allow the reader to warm up for at least 20 minutes before running any patient samples.
Setup25Setting the Date and TimePerform the following steps to set the date and time:1. When the Set Date screen is first displayed, the Date format field is highlighted. Use and to scroll through the following options for how to display dates on the reader screen and printouts:■dd.mm.yyyy: Select this option to display the day, then the month, then the year with periods used as separators.■mm/dd/yyyy: Select this option to display the month, then the day, then the year with slashes used as separators.■yyyy/mm/dd: Select this option to display the year, then the month, then the day with slashes used as separators.When the preferred date format is displayed, press to highlight the Year field.2. Use or to increment or decrement the year.When the correct year is displayed, press to highlight the Month field.3. Use or to increment or decrement the month.When the correct month is displayed, press to highlight the Day field.4. Use or to increment or decrement the day.When the correct day is displayed, review the date format, year, month, and day, and confirm that the correct date information is displayed. If you need to change a setting, use and to highlight the field. Then use and to make the necessary changes.5. When you have confirmed that the correct date is displayed, press Confirm & Next to display the Set Time screen.Set Time Screen
Apex Reader User’s Guide266. When the Set Time screen is first displayed, the Time format field is highlighted. Use and to toggle between the following options for how to display times on the reader screen and printouts:■12h: Select this option to display times in the 12 hour time format with am and pm.■24h: Select this option to display times in the 24 hour time format.When the preferred time format is displayed, press to highlight the Hour field.7. Use or to increment or decrement the hour.When the correct hour is displayed, press to highlight the Minute field.8. Use or to increment or decrement the minute.When the correct minute is displayed, review the time format, hour, and minute and confirm that the correct time information is displayed. If you need to change a setting, use and to highlight the field. Then use and to make the necessary changes.9. When you have confirmed that the correct time is displayed, press Confirm to display the Enter Patient ID screen.After the reader has been allowed to warm up for 20 minutes, you can begin running patient tests. See Testing a Patient Sample on page68 for instructions.
Setup27Installing the PaperThe reader can print test results, device settings, and other information using the thermal paper rolls included in the reader kit.Perform the following steps to install paper in the reader:1. Remove the printer cover by pulling up the blue handle on the top of the cover.2. If necessary, tear or cut the end of the paper roll to form a straight edge. Then insert the paper roll in the printer so that the end of the paper comes from under the roll toward the reader display, as shown below.Removing the Printer CoverInserting the Paper Roll
Apex Reader User’s Guide283. To replace the printer cover, insert the paper roller between the edge of the paper and the paper roll, as shown below. Then push down on the sides of the printer cover until you hear it snap into place.4. Press .The reader feeds the paper so that it extends out the top of the printer.5. After the reader has been allowed to warm up for 20 minutes, you can begin running patient tests. See Testing a Patient Sample on page68 for instructions.In order to change any reader settings, you will need to add a supervisor user. See Adding the First Supervisor User on page29 for instructions.Replacing the Printer Cover
Setup29Adding the First Supervisor UserYou must add the first supervisor user before you can change any reader settings. In order to add the first supervisor user, you need to obtain a one-shot PIN by calling AspenBio Pharma Customer Care at 1-303-794-2000.When you have obtained a one-shot PIN, perform the following steps to create the first supervisor user:1. Press to display the operator Main Menu screen.2. Use and to highlight Maintenance and press Select to display the Maintenance screen.Operator Main Menu ScreenMaintenance ScreenIMPORTANT: A one-shot PIN can be used only on the day when it is provided. You should add the first supervisor user as soon as you obtain this PIN.
Apex Reader User’s Guide303. Use and to highlight Change to Supervisor and press Select to display the Enter One Shot PIN screen.4. Use the numeric keypad to enter your one-shot PIN in the One Shot PIN field, then press Confirm to display the First Change to Supervisor confirmation screen.5. Press OK to display the Enter User ID screen.6. When the Enter User ID screen is first displayed, the User ID field is highlighted. Use the numeric keypad to enter the user ID for the first supervisor user. The user ID must be 4 digits.7. Press to highlight the PIN field.Enter One Shot PIN ScreenFirst Change to Supervisor Confirmation ScreenEnter User ID ScreenNOTE: To delete the last character entered, press .
Setup318. Use the numeric keypad to enter the PIN for this user. The PIN must be 4 digits.9. Press to highlight the Confirm PIN field.10. Re-enter the 4-digit PIN for this user.11. Press Confirm & Next to display the Enter User Name screen.12. Perform the following steps to enter the user name for this user:a. Use , , , and to highlight the desired character.b. Press Confirm & Next to add the highlighted character to the user name.c. Repeat Step a and Step b as necessary.13. When the user name is complete, use , , , and to highlight Done. Then press Confirm & Next to display the Barcode screen.Enter User Name ScreenBarcode Screen
Apex Reader User’s Guide3214. The following options are available on the Barcode screen:a. To assign a barcode for this user, use and to highlight Assign. Then use the external barcode reader to scan the barcode.The reader assigns the barcode and displays the RFID screen.b. If you do not want to assign a barcode, use and to highlight Skip. Then press Confirm & Next to display the RFID screen.15. The following options are available on the RFID screen:a. To assign an RFID for this user, use and to highlight Assign. Place the user’s ID card on the designated location on the reader and press Confirm. AG: CLARIFY.The reader assigns the RFID and displays the User Administration screen.b. If you do not want to assign an RFID, use and to highlight Skip. Then press Confirm to display the User Administration screen.16. After the first supervisor user has been added, you can set up the LIS connection, change reader settings, or add more users. Refer to the appropriate section below for instructions:■Connecting to the LIS on page33■Changing Reader Settings on page38■Managing Users on page47After the reader has been allowed to warm up for 20 minutes, you can begin running patient tests. See Testing a Patient Sample on page68 for instructions.NOTE: To delete this user’s barcode, return to the Barcode screen and use and to highlight Reset. Then press Confirm & Next.RFID ScreenNOTE: To delete this user’s RFID, return to the RFID screen and use and to highlight Reset. Then press Confirm.
Setup33Connecting to the LISThe reader can send test results to the LIS over an Ethernet connection. Complete the following steps to set up the LIS connection.Setting Up the Network ConnectionPerform the following steps to set up the network connection. If you are not using DHCP, you need to obtain the IP address, port number, subnet mask, and standard gateway for the reader from your network administrator.1. Connect an Ethernet cable to the reader by inserting one end of the cable into the Ethernet port in the back of the reader.2. Connect the other end of the Ethernet cable to the LIS network.3. Press to display the supervisor Main Menu screen.NOTE: Only supervisor users can modify these settings. If you are logged in as an operator, select Maintenance > Change to Supervisor to set up the LIS connection.Connecting the Ethernet CableSupervisor Main Menu Screen
Apex Reader User’s Guide344. Use and to highlight Settings and press Select to display the supervisor Settings screen.5. Use and to highlight Network Setup and press Select to display the Network Setup screen. AG: UPDATE SCREEN.6. Use and to highlight Network Configuration and press Select to display the Network Configuration screen.Supervisor Settings ScreenNetwork Setup ScreenNetwork Configuration Screen
Setup357. The following options are available on the Network Configuration screen:■To obtain the reader’s IP address, port number, subnet mask, and standard gateway automatically using DHCP, use and to highlight DHCP. Then press Select.The reader obtains the network information and displays the Network Setup screen.■To enter the reader’s IP address, port number, subnet mask, and standard gateway manually, use and to highlight Manual. Then press Select to display the Manual Network Setup screen.a. When the Manual Network Setup screen is first displayed, the IP address field is highlighted. Use the numeric keypad to enter the IP address for the reader. Then press to highlight the Port number field.b. Use the numeric keypad to enter the port number for the reader. Then press to highlight the Subnet Mask field.c. Use the numeric keypad to enter the subnet mask for the reader. Then press to highlight the Standard Gateway field.d. Use the numeric keypad to enter the standard gateway for the reader.Review the IP address, port number, subnet mask, and standard gateway and confirm that the correct information is displayed. If you need to change a setting, use and to highlight the field. Then use the numeric keypad to make the necessary changes.e. When you have confirmed that the correct information is displayed, press Confirm to save these settings and return to the Network Setup screen.NOTE: To delete the last character entered, press .
Apex Reader User’s Guide36Providing LIS SettingsPerform the following steps to configure the LIS reviewer settings for the reader. You need to obtain the IP address and port number for the LIS reviewer from your network administrator. 1. Press to display the supervisor Main Menu screen.2. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight LIS Reviewer Setup and press Select to display the LIS Reviewer Settings screen.Supervisor Main Menu ScreenSupervisor Settings ScreenLIS Reviewer Settings Screen
Setup374. When the LIS Reviewer Settings screen is first displayed, the Set Timeout field is highlighted. Use and to increment or decrement the timeout for the LIS reviewer. The timeout is the amount of time after which the reader will stop trying to communicate with the LIS.5. When the desired setting is displayed in the Set Timeout field, press to highlight the Reviewer IP Address field.6. Use and to increment or decrement the IP address for the LIS reviewer. Then press to highlight the Port Number field.7. Use and to increment or decrement the port number for the LIS reviewer.8. Review the timeout, IP address, and port number and confirm that the correct information is displayed. If you need to change a setting, use and to highlight the field. Then use and to make the necessary changes.9. When you have confirmed that the correct information is displayed, press Confirm & Exit to return to the supervisor Settings screen.
Apex Reader User’s Guide38Changing Reader SettingsSupervisor users can modify the following reader settings:■Language: The language setting determines what language is displayed on the reader screen and printouts. For instructions on how to change the language, see Changing the Language on page39.■Patient ID Settings: The patient ID settings determine whether patient IDs can be input by an external barcode reader and whether they can be input by manual entry. For instructions on how to change the patient ID settings, see Changing Patient ID Settings on page40.■Print Setting: The print setting determines whether test results are printed automatically upon completion of a patient test. For instructions on how to change printing setup, see Changing the Print Setting on page43.■Logout Time: The logout time setting is the duration of inactivity after which a user will be automatically logged out of the reader. For instructions on how to change the logout time, see Changing Security and Power Saving Settings on page44.■Power Off Time: The power off time is the duration of inactivity after which the reader will automatically turn off. For instructions on how to change the power off time, see Changing Security and Power Saving Settings on page44.■Auto-Login Setting: The auto-login setting determines whether users are required to enter a login and PIN to use the reader. For instructions on how to change the auto-login setting, see Changing Security and Power Saving Settings on page44.NOTE: Only supervisor users can change reader settings. If you are logged in as an operator, select Maintenance > Change to Supervisor. to change settings.
Setup39Changing the LanguageSupervisor users can change the reader’s language setting. The language setting determines what language is displayed on the reader screen and printouts.Perform the following steps to change the language:1. Press to display the supervisor Main Menu screen.2. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight Select Language and press Select to display the Set Language screen.You can scroll through the available languages using and . The selected radio button indicates the current reader language.Supervisor Main Menu ScreenSupervisor Settings ScreenSet Language Screen
Apex Reader User’s Guide404. Use and to highlight the desired language.5. When the desired language is highlighted, press Select to save this setting.6. Press Back to return to the supervisor Settings screen or press to return to the supervisor Main Menu screen.Changing Patient ID SettingsSupervisor users can change patient ID settings. The patient ID settings determine whether patient IDs can be input by an external barcode reader and whether they can be input by manual entry.Perform the following steps to change the patient ID settings:1. Press to display the supervisor Main Menu screen.2. Use and to highlight Settings and press Select to display the supervisor Settings screen.Supervisor Main Menu ScreenSupervisor Settings Screen
Setup413. Use and to highlight Set Patient ID and press Select to display the Patient ID screen.4. Perform the following steps to enable or disable use of an external barcode reader for reading the patient ID:a. Use and to highlight Set Barcode Reader and press Select to display the Set Barcode Reader screen.The selected radio button indicates the current setting.b. Use and to highlight the desired setting.– If you select Enabled, users will be able to use an external barcode reader to enter patient IDs.– If you select Disabled, users will not be able to use an external barcode reader to enter patient IDs. Patient IDs will have to be input to the reader manually or by RFID.c. When the desired setting is highlighted, press Select to save this setting.d. Press Back to return to the Patient ID screen.Patient ID ScreenSet Barcode Reader Screen
Apex Reader User’s Guide425. Perform the following steps to enable or disable manual entry of the patient ID:a. Use and to highlight Manual Entry and press Select to display the Allow Manual Entry screen.The selected radio button indicates the current setting.b. Use and to highlight the desired setting.– If you select Enabled, users will be able to enter patient IDs manually.– If you select Disabled, users will not be able to enter patient IDs manually. Patient IDs will have to be input to the reader by an external barcode reader or by RFID.c. When the desired setting is highlighted, press Select to save this setting.d. Press Back to return to the Patient ID screen or press to return to the supervisor Main Menu screen.Allow Manual Entry Screen
Setup43Changing the Print SettingSupervisor users can change the print setting. The print setting determines whether test results are printed automatically upon completion of a patient test.Perform the following steps to change the patient ID settings:1. Press to display the supervisor Main Menu screen.2. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight Printing Setup and press Select to display the Printing Setup screen.The selected radio button indicates the current setting.Supervisor Main Menu ScreenSupervisor Settings ScreenPrinting Setup Screen
Apex Reader User’s Guide444. Use and to highlight the desired setting.■If you select Automatically, test results will be printed automatically upon completion of a patient test.■If you select Manually, test results will not be printed automatically upon completion of a patient test. Results will have to be printed manually by the user.5. When the desired setting is highlighted, press Select to save this setting.6. Press Back to return to the supervisor Settings screen or press to return to the supervisor Main Menu screen.Changing Security and Power Saving SettingsSupervisor users can change the following security and power saving settings:■Logout Time: The logout time setting is the duration of inactivity after which a user will be automatically logged out of the reader.■Power Off Time: The power off time is the duration of inactivity after which the reader will automatically turn off.■Auto-Login Setting: The auto-login setting determines whether users are required to enter a login and PIN to use the reader.Perform the following steps to change the logout time, power off time, or auto-login setting:1. Press to display the supervisor Main Menu screen.Supervisor Main Menu Screen
Setup452. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight Set Login / Logout and press Select to display the Set Login / Logout screen.4. Perform the following steps to change the logout time and/or power off time:a. Use and to highlight Set Timeouts and press Select to display the Set Timeouts screen.The current logout time and power off time are shown.Supervisor Settings ScreenSet Login / Logout ScreenSet Timeouts Screen
Apex Reader User’s Guide46b. When the Set Timeouts screen is first displayed, the Logout Time field is highlighted. If necessary, use and to increment or decrement the logout time.c. When the desired logout time is displayed, press to highlight the Power Off Time field.d. If necessary, use and to increment or decrement the power off time.e. When the desired power off time is displayed, press Confirm to save these settings and return to the Set Login / Logout screen.5. Perform the following steps to change the auto-login setting:a. On the Set Login / Logout screen, use and to highlight Set Auto-Login and press Select to display the Set Auto-Login screen.The selected radio button indicates the current setting.b. Use and to highlight the desired setting.– If you select Enabled, users will not be required to enter a login and PIN to use the reader.– If you select Disabled, users will be required to enter a login and PIN to use the reader.c. When the desired setting is highlighted, press Select to save this setting.d. Press Back to return to the Set Login / Logout screen.NOTE: Select a logout time of 0 minutes if you never want users to be automatically logged out of the reader.NOTE: Select a power off time of 0 minutes if you never want the reader to automatically turn off.Set Auto-Login Screen
Setup47Managing UsersSupervisor users can add new users and modify or delete existing user records. See the following pages for instructions:■To add a new user, see Adding a User on page47.■To modify the login information, user name, or user mode for an existing user, see Changing User Information on page51.■To enable or disable a user record, see Enabling or Disabling a User on page55.■To delete a user record, see Deleting a User on page57.Adding a UserPerform the following steps to create a new user:1. Press to display the supervisor Main Menu screen.2. Use and to highlight User Administration and press Select to display the User Administration screen.The number at the bottom of the screen indicates the number of available user entries.NOTE: Only supervisor users can modify user settings. If you are logged in as an operator, select Maintenance > Change to Supervisor to add, modify, or delete a user record.Supervisor Main Menu ScreenUser Administration Screen
Apex Reader User’s Guide483. Use and to highlight Create new ID and press Select to display the Enter User ID screen.4. When the Enter User ID screen is first displayed, the User ID field is highlighted. Use the numeric keypad to enter the user ID for this user. The user ID must be 4 digits.5. Press to highlight the PIN field.6. Use the numeric keypad to enter the PIN for this user. The PIN must be 4 digits.7. Press to highlight the Confirm PIN field.8. Re-enter the 4-digit PIN for this user.9. Press Confirm & Next to display the Enter User Name screen.10. Perform the following steps to enter the user name for this user:a. Use , , , and to highlight the desired character.b. Press Confirm & Next to add the highlighted character to the user name.c. Repeat Step a and Step b as necessary.Enter User ID ScreenNOTE: To delete the last character entered, press .Enter User Name Screen
Setup4911. When the user name is complete, use , , , and to highlight Done. Then press Confirm & Next to display the Set Mode screen.12. Use and to highlight the desired setting.■If you select Operator, this user will not have access to supervisor functionality.■If you select Supervisor, this user will have access to all reader functionality.When the desired setting is highlighted, press Confirm & Next to display the Barcode screen.Set Mode ScreenBarcode Screen
Apex Reader User’s Guide5013. The following options are available on the Barcode screen:a. To assign a barcode for this user, use and to highlight Assign. Then use the external barcode reader to scan the barcode.The reader assigns the barcode and displays the RFID screen.b. If you do not want to assign a barcode, use and to highlight Skip. Then press Confirm & Next to display the RFID screen.14. The following options are available on the RFID screen:a. To assign an RFID for this user, use and to highlight Assign. Place the user’s ID card on the designated location on the reader and press Confirm. AG: CLARIFY.The reader assigns the RFID, saves this user, and returns to the User Administration screen.b. If you do not want to assign an RFID, use and to highlight Skip. Then press Confirm.The reader saves this user and returns to the User Administration screen.NOTE: To delete this user’s barcode, return to the Barcode screen and use and to highlight Reset. Then press Confirm & Next.RFID ScreenNOTE: To delete this user’s RFID, return to the RFID screen and use and to highlight Reset. Then press Confirm.
Setup51Changing User InformationPerform the following steps to modify the login information, user name, or user mode for an existing user:1. Press to display the supervisor Main Menu screen.2. Use and to highlight User Administration and press Select to display the User Administration screen.3. Use and to highlight Organize existing IDs and press Select to display the User ID List screen.The reader displays the user ID, user name, user mode, and status for all users that have been added, arranged numerically by user ID. You can use and to scroll through user records.Supervisor Main Menu ScreenUser Administration ScreenUser ID List Screen
Apex Reader User’s Guide524. Use and to highlight the user record you want to modify and pressOptions a to display the User ID Options screen. AG: UPDATE SCREEN.5. To modify the login information for this user:a. Use , , , and to highlight Edit ID and press Select to display the Edit User ID screen.The user’s current user ID and PIN are displayed.b. When the Edit User ID screen is first displayed, the User ID field is highlighted. If necessary, press to delete characters from the current user ID. Then use the numeric keypad to enter the new user ID for this user. The user ID must be 4 digits.When the desired user ID is displayed, press to highlight the PIN field.c. If necessary, use to delete characters from the current PIN. Then use the numeric keypad to enter the new PIN for this user. The PIN must be 4 digits.When the desired PIN has been entered, press to highlight the Confirm PIN field. User ID Options ScreenEdit User ID Screen
Setup53d. If you entered a new PIN, re-enter the 4-digit PIN for this user. Then press Confirm & Next to display the Barcode screen.e. The following options are available on the Barcode screen:–If you do not want to assign a barcode, use and to highlight Skip. Then press Confirm & Next to display the RFID screen.–To delete this user’s barcode, use and to highlight Reset. Then press Confirm & Next to display the RFID screen.–To assign a new barcode for this user, use and to highlight Assign. Then use the external barcode reader to scan the barcode. The reader assigns the barcode and displays the RFID screen.Barcode ScreenRFID Screen
Apex Reader User’s Guide54f. The following options are available on the RFID screen:–If you do not want to assign an RFID, use and to highlight Skip. Then press Confirm to return to the User ID Options screen.–To delete this user’s RFID, use and to highlight Reset. Then press Confirm to return to the User ID Options screen–To assign a new RFID for this user, use and to highlight Assign. Place the user’s ID card on the designated location on the reader and press Confirm. AG: CLARIFY.The reader assigns the RFID and returns to the User ID Options screen.6. To modify the user name for this user:a. Use , , , and to highlight Edit Name and press Select to display the Edit User Name screen.The user’s current user name is displayed.b. Enter the new user name.– To delete a character, press .– To add a character, use , , , and to highlight the desired character. Then press Confirm & Next to add the highlighted character to the user name.c. When the user name is complete, use , , , and to highlight Done. Then press Select to return to the User ID Options screen.Edit User Name Screen
Setup557. To modify the user mode for this user:a. Use , , , and to highlight Change Mode and press Select to display the Change Mode screen.The user’s current user mode is highlighted.b. Use and to highlight the desired setting.– If you select Operator, this user will not have access to supervisor functionality.– If you select Supervisor, this user will have access to all reader functionality.c. When the desired setting is highlighted, press Select to save this setting.d. Press Back to return to the User ID Options screen.8. When you have finished modifying the settings for this user, press Cancel b to return to the User ID List screen or press to return to the supervisor Main Menu screen.Enabling or Disabling a UserPerform the following steps to enable or disable an existing user record:1. Press to display the supervisor Main Menu screen.Change Mode ScreenNOTE: You can disable the user record for a user who does not currently need to use the reader, but might need to use it in the future.Supervisor Main Menu Screen
Apex Reader User’s Guide562. Use and to highlight User Administration and press Select to display the User Administration screen.3. Use and to highlight Organize existing IDs and press Select to display the User ID List screen.The reader displays the user ID, user name, user mode, and status for all users that have been added, arranged numerically by user ID. You can use and to scroll through user records.4. Use and to highlight the user record you want to enable or disable and press Options a to display the User ID Options screen.User Administration ScreenUser ID List ScreenUser ID Options Screen
Setup575. Use , , , and to highlight Set enabled / disabled and press Select to display the Change Status screen.The user’s current status is highlighted.6. Use and to highlight the desired setting.■If you select Enabled, this user will be able to log in to the reader.■If you select Disabled, this user will no longer be able to log in to the reader.7. When the desired setting is highlighted, press Select to save this setting.8. Press Back to return to the User ID Options screen.9. When you have finished modifying the settings for this user, press Cancel b to return to the User ID List screen or press to return to the supervisor Main Menu screen.Deleting a UserPerform the following steps to delete a user record:1. Press to display the supervisor Main Menu screen.Change Status ScreenNOTE: You can delete the user record for a user who no longer needs to use the reader.Supervisor Main Menu Screen
Apex Reader User’s Guide582. Use and to highlight User Administration and press Select to display the User Administration screen.3. Use and to highlight Organize existing IDs and press Select to display the User ID List screen.The reader displays the user ID, user name, user mode, and status for all users that have been added, arranged numerically by user ID. You can use and to scroll through user records.4. Use and to highlight the user record you want to delete and pressOptions a to display the User ID Options screen.User Administration ScreenUser ID List ScreenUser ID Options Screen
Setup595. Use , , , and to highlight Delete User and press Select to display the Delete User confirmation screen.The screen displays the user name for the selected user.6. The following options are available on the Delete User confirmation screen.■To delete this user record, press Delete. The selected user record is deleted and the reader returns to the User ID List screen.■To keep this user record and return to the User ID Options screen, press Cancel.7. When you have finished deleting user records, press to return to the supervisor Main Menu screen.Delete User Confirmation Screen
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61Daily OperationsStartupThis section provides information on preparing the reader for daily use. The following tasks must be completed prior to testing patient samples:■The reader must be powered on.■A user must log in to the reader (unless the reader’s auto-login feature is enabled).■A quality control check must be performed if required by laboratory procedures.Turning On the ReaderThe on/off switch is located on the back of the reader. To turn on the reader, push the on/off switch up until the Initializing screen appears, then release it. The reader displays a splash screen during startup, then displays one of the following screens:■The Login screen is displayed if the reader’s auto-login feature is disabled.■The Enter Patient ID screen is displayed if the reader’s auto-login feature is enabled.IMPORTANT: Allow the reader to warm up for at least 20 minutes before running any patient samples.
Apex Reader User’s Guide62Logging InIf necessary, perform the following steps to log in to the reader:1. On the Login screen, enter your 4-digit user ID or barcode number using one of the following methods:■Place your ID card on the designated location on the reader. Then go to Step 4. AG: CLARIFY.■Use the numeric keypad to enter your user ID manually.■Use the external barcode reader to scan your barcode.2. Press to highlight the PIN field.3. Enter your 4-digit PIN. AG: CONFIRM FOR USE OF AN ID CARD OR BARCODE.4. Press Login to log in as an operator.NOTE: To delete the last character entered, press .Login ScreenNOTE: You can also press Supervisor Login to log in as a supervisor. If you log in as a supervisor, you will need to select Change to Operator to test patient samples.
Daily Operations63Running Quality Control ChecksQuality control (QC) testing ensures that the reader is operating within acceptable ranges. QC routines are mandatory and patient tests should not be performed unless required QC is complete. The manufacturer’s recommendation for QC testing is to test 1 high control and 1 low control per box of test cartridges.The reader performs initialization and self-checks each time it is powered on. These checks ensure that:■Communication between the different reader modules is working.■The optics are functioning properly.■The carriage is free to move correctly.■The carriage position is zeroed.From the Check Reader screen, you can run an internal QC check on the reader. You can also run an external QC check using the system check cassette provided with the reader. The result of a QC check can be sent to the LIS or printed. This result is stored in the reader until the next QC check is performed, then the previous result is over-written with the new result.Perform the following steps to run an internal QC check:1. Press to display the Main Menu screen. IMPORTANT: Each day that testing is to be performed, the reader should be powered on and allowed to complete its initialization and self-checks.NOTE: To send the result of a QC check to the LIS, the reader must be connected to the LIS and the LIS must have been set up by a supervisor. See Connecting to the LIS on page33 for instructions. Supervisor Main Menu Screen Operator Main Menu ScreenIMPORTANT: Follow laboratory procedures regarding how frequently to perform QC checks and how to document the results.
Apex Reader User’s Guide642. If you are logged in as a supervisor, skip this step and go to Step 3.If you are logged in as an operator, use and to highlight Maintenance and press Select to display the Maintenance screen.3. Use and to highlight Check Reader and press Select to display the Check Reader screen.4. Use and to highlight Internal Hard Standard or Internal Check and press Select.The reader performs an internal check, then displays the Internal Check Result screen.Maintenance Screen Supervisor Check Reader Screen Operator Check Reader ScreenInternal Check Result Screen
Daily Operations655. To send the result of the internal check to the LIS:a. Press Options.b. Use and to highlight Send Result and press Select.The reader sends the result, then returns to the Check Reader screen.6. To print the result of the internal check:a. Press Options.b. Use and to highlight Print Result and press Select.The reader prints the result, then returns to the Check Reader screen.7. Press Back to return to the Check Reader screen or press to return to the Main Menu screen.Perform the following steps to run an external QC check:1. Press to display the Main Menu screen. Internal Check Result Screen — Options Supervisor Main Menu Screen Operator Main Menu Screen
Apex Reader User’s Guide662. If you are logged in as a supervisor, skip this step and go to Step 3.If you are logged in as an operator, use and to highlight Maintenance and press Select to display the Maintenance screen.3. Use and to highlight Check Reader and press Select to display the Check Reader screen.4. Use and to highlight External Control or External Check and press Select to display the Insert Cartridge screen.5. Press to eject the drawer. AG: TBD IF THIS STEP IS NECESSARY.Maintenance Screen Supervisor Check Reader Screen Operator Check Reader ScreenInsert Cartridge Screen — External Check
Daily Operations676. Insert the system check cassette in the reader with the sample application area facing toward you. Then close the drawer and press Start Test.The reader performs a check using the system check cassette, then displays the External Check Result screen.7. To send the result of the external check to the LIS:a. Press Options.b. Use and to highlight Send Result and press Select.The reader sends the result, then returns to the Check Reader screen.8. To print the result of the external check:a. Press Options.b. Use and to highlight Print Result and press Select.The reader prints the result, then returns to the Check Reader screen.9. Press to eject the drawer. Remove the system check cassette and store it in its original foil pouch.External Check Result ScreenNOTE: You can select Send All to send the results of all external checks performed using this system check cassette. AG: CONFIRMExternal Check Result Screen — OptionsNOTE: You can select Print All to print the results of all external checks performed using this system check cassette. AG: CONFIRMIMPORTANT: To avoid light exposure, store and reseal the system check cassette in its original foil pouch immediately after each use.
Apex Reader User’s Guide6810. Press Back to return to the Check Reader screen or press to return to the Main Menu screen.Testing a Patient SamplePerform the following steps to test a patient sample:1. Press to display the operator Main Menu screen.2. Use and to highlight Run Test and press Select to display the Enter Patient ID screen.IMPORTANT: Allow the reader to warm up for at least 20 minutes before running any patient samples.NOTE: The Run Test menu item is not available on the supervisor Main Menu screen. If you are logged in as a supervisor, select Change to Operator to display the operator Main Menu screen.Operator Main Menu ScreenEnter Patient ID Screen
Daily Operations693. Enter the patient ID using one of the following methods:■Use the external barcode reader to scan the patient’s barcode.■Use the numeric keypad to enter the patient ID.■Press Keypad to enter letters, spaces, and punctuation.a. When the keypad is displayed on the reader’s screen, use , , , and to highlight the desired character.b. Press Confirm & Next to add the highlighted character to the patient ID.c. Repeat Step a and Step b as necessary.d. When the patient ID is complete, press Back to exit the Keypad feature.4. On the Enter Patient ID screen, press Confirm to display the Insert Cartridge screen.5. Press to eject the drawer.6. Prepare the test sample in accordance with the instructions provided in the package of test cartridges.NOTE: To delete the last character entered, press .Keypad ScreenInsert Cartridge Screen — Run Test
Apex Reader User’s Guide707. Gently insert the prepared test cartridge in the drawer with the sample application area facing toward you as shown below. Then close the drawer.The reader displays the status of the test on the Run Test screen, then displays the Test Result screen when the test is complete.8. Press Next to display the Confirm Patient ID screen.Test Cartridge in Reader DrawerTest Result ScreenConfirm Patient ID Screen
Daily Operations719. Confirm that the patient ID displayed on this screen is correct.■If the patient ID is correct, press Confirm to view the test result on the Result List screen. If the reader’s automatic printing feature is enabled, the result is printed automatically.■If the patient ID is incorrect:a. Enter the appropriate patient ID and press Confirm to display the Patient ID does not match screen.b. Re-enter the patient ID and press Confirm to view the test result on the Result List screen. If the reader’s automatic printing feature is enabled, the result is printed automatically.10. Press to eject the drawer. Remove the test cartridge and dispose or store as appropriate. AG: NEED INPUT.Result List ScreenPatient ID Does Not Match ScreenNOTE: To delete the last character entered, press .
Apex Reader User’s Guide72Managing Patient ResultsThe Result List screen displays basic information for each patient test result stored in the reader’s memory. From the Result List screen you can:■view details for a patient test result■send patient test results to the LIS■print patient test resultsYou can also view, send, and print an individual result stored on a test cartridge.Viewing Detailed Test ResultsPerform the following steps to view detailed information for test results stored in the reader’s memory:1. Press to display the operator Main Menu screen.NOTE: To send a patient result to the LIS, the reader must be connected to the LIS and the LIS must have been set up by a supervisor. See Connecting to the LIS on page33 for instructions.Operator Main Menu ScreenIMPORTANT: Results are stored in the reader’s memory for temporary backup purposes only. The reader can store up to 100 patient test results. When the reader’s memory is full, a warning message is displayed prompting user action. If no action is taken, results are overwritten as new tests are completed, starting with the oldest result in memory.
Daily Operations732. Use and to highlight Result History and press Select to display the Result History screen.3. Use and to highlight Organize Results and press Select to display the Result List screen.The reader displays the patient ID, date, time, and test result for all results stored in the reader’s memory, starting with the most recent test performed. You can scroll through results using and .4. Use and to highlight the desired result and press Options a to display the Result List Options screen.NOTE: The Result History menu item is not available on the supervisor Main Menu screen. If you are logged in as a supervisor, select Change to Operator to display the operator Main Menu screen.Result History ScreenResult List ScreenResult List Options Screen
Apex Reader User’s Guide745. Use and to highlight Show Details and press Select to display the Detailed Result screen.The following information is available on the Detailed Result screen:■Patient ID: The complete patient ID recorded for the test.■Assay: The assay type that was performed (Appy Score).■Result: The result of the test.■Time: The time and date the test was performed.■Cartridge #: The number of the cartridge used for the test.■Op ID: The ID for the operator that performed the test.■Buffer #: The lot number of the buffer used for the test.■Conjugate #: The lot number of the conjugate used for the test.■Temperature: The temperature recorded in the reader at the time the test was performed.■Last LQC: The date of the last LQC performed on the reader.6. When you have finished viewing result details, press Back to return to the Result List screen.Detailed Result Screen
Daily Operations75Sending Patient ResultsPerform the following steps to send patient results stored in the reader’s memory to the LIS:1. Press to display the operator Main Menu screen.2. Use and to highlight Result History and press Select to display the Result History screen.3. Use and to highlight Organize Results and press Select to display the Result List screen.The reader displays the patient ID, date, time, and test result for all results stored in the reader’s memory, starting with the most recent test performed. You can scroll through results using and .Operator Main Menu ScreenNOTE: The Result History menu item is not available on the supervisor Main Menu screen. If you are logged in as a supervisor, select Change to Operator to display the operator Main Menu screen.Result History ScreenResult List Screen
Apex Reader User’s Guide764. Use and to highlight the result you want to send and pressOptions a to display the Result List Options screen.5. To send only the selected result:a. Use and to highlight Send Result and press Select.b. The reader sends the result, then returns to the Result List screen.6. To send all patient results stored in the reader’s memory:a. Use and to highlight Send All and press Select.b. The reader sends the results, then returns to the Result List screen.7. To send all positive results stored in the reader’s memory:a. Use and to highlight Send Positive and press Select.b. The reader sends the results, then returns to the Result List screen.Printing Patient ResultsPerform the following steps to print patient results stored in the reader’s memory:1. Press to display the operator Main Menu screen.Result List Options ScreenOperator Main Menu Screen
Daily Operations772. Use and to highlight Result History and press Select to display the Result History screen.3. Use and to highlight Organize Results and press Select to display the Result List screen.The reader displays the patient ID, date, time, and test result for all results stored in the reader’s memory, starting with the most recent test performed. You can scroll through results using and .4. Use and to highlight the desired result and press Options a to display the Result List Options screen.NOTE: The Result History menu item is not available on the supervisor Main Menu screen. If you are logged in as a supervisor, select Change to Operator to display the operator Main Menu screen.Result History ScreenResult List ScreenResult List Options Screen
Apex Reader User’s Guide785. To print only the selected result:a. Use and to highlight Print Result and press Select.b. The reader prints the result, then returns to the Result List screen.6. To print all patient results stored in the reader’s memory:a. Use and to highlight Print All and press Select.b. The reader prints the results, then returns to the Result List screen.7. To print all positive results stored in the reader’s memory:a. Use and to highlight Print Positive and press Select.b. The reader prints the results, then returns to the Result List screen.Viewing a Result Stored on a Test CartridgePerform the following steps to view an individual result stored on a test cartridge:1. Press to display the operator Main Menu screen.2. Use and to highlight Result History and press Select to display the Result History screen. 3. Place the test cartridge on the designated location on the reader. AG: CLARIFY.Operator Main Menu ScreenNOTE: The Result History menu item is not available on the supervisor Main Menu screen. If you are logged in as a supervisor, select Change to Operator to display the operator Main Menu screen.Result History Screen
Daily Operations794. Use and to highlight Read Cartridge and press Select to display the Read Result on Cartridge screen.The reader displays the patient ID, date, time, and test result for the result stored on the test cartridge.5. To view detailed information for the test result:a. Press Options a to display the Read Cartridge Options screen. b. Use and to highlight Show Details and press Select to display the Read Cartridge Details screen.Read Result on Cartridge ScreenRead Cartridge Options Screen
Apex Reader User’s Guide80The following information is available on the Read Cartridge Details screen:–Patient ID: The complete patient ID recorded for the test.–Assay: The assay type that was performed (Appy Score).–Result: The result of the test.–Time: The time and date the test was performed.–Cartridge #: The number of the cartridge used for the test.–Op ID: The ID for the operator that performed the test.–Buffer #: The lot number of the buffer used for the test.–Conjugate #: The lot number of the conjugate used for the test.–Temperature: The temperature recorded in the reader at the time the test was performed.–Last LQC: The date of the last LQC performed on the reader.c. When you have finished viewing result details, press Back to return to the Read Cartridge Options screen.6. To send the test result to the LIS:a. Press Options a to display the Read Cartridge Options screen.b. Use and to highlight Send to LIS and press Select.c. The reader sends the result, then returns to the Read Cartridge Options screen.7. To print the test result:a. Press Options a to display the Read Cartridge Options screen.b. Use and to highlight Print Result and press Select.c. The reader prints the result, then returns to the Read Cartridge Options screen.Read Cartridge Details Screen
Daily Operations81Daily ShutdownTurn off the reader at the end of each day. To turn off the reader, push the on/off switch up, then release it.
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83Export / Import FeaturesSupervisor users can export information to and import information from an SD card.To install the SD card, insert the card into the SD card slot in the back of the reader as shown below. Ensure that the metallic contacts on the edge of the card are facing toward the outside of the reader as shown in the figure below. Push in the card until you feel resistance.■To export test results stored on the reader to the SD card, see Exporting Stored Test Results on page84.■To export the last 10 raw data scans stored on the reader to the SD card, see Exporting Raw Test Data on page86.■To export user records to or import user records from the SD card, see Importing and Exporting Users on page87.NOTE: Only supervisor users can use the reader’s export / import features. If you are logged in as an operator, select Maintenance > Change to Supervisor to export or import information.Installing the SD Card
Apex Reader User’s Guide84Exporting Stored Test ResultsPerform the following steps to export test results stored on the reader to the SD card:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.3. Use and to highlight Import / Export and press Select to display the Import / Export screen.Supervisor Main Menu ScreenImport / Export Screen
Export / Import Features854. Use and to highlight Export Result List and press Select to display the Export Result List screen.The reader displays the patient ID, date, time, and test result for all results stored in the reader’s memory, starting with the most recent test performed. You can scroll through results using and .5. Press Export to export the result list.The reader displays the Export Successful screen when the result list has been exported to the SD card.6. Press OK to return to the Export Result List screen or press Main Menu to return to the supervisor Main Menu screen.Export Result List ScreenExport Successful Screen — Result List
Apex Reader User’s Guide86Exporting Raw Test DataPerform the following steps to export the last 10 raw data scans stored on the reader to the SD card:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.3. Use and to highlight Import / Export and press Select to display the Import / Export screen.4. Use and to highlight Export Raw Data Scan and press Select to export the last 10 raw data scans.The reader displays the Export Successful screen when the data has been exported to the SD card.Supervisor Main Menu ScreenImport / Export ScreenExport Successful Screen — Raw Data
Export / Import Features875. Press OK to return to the Import / Export screen or press to return to the supervisor Main Menu screen.Importing and Exporting UsersSupervisor users can export user records to or import user records from the SD card.■To export the user record for a selected user to the SD card, see Exporting a User on page87.■To export user records for multiple users to the SD card, see Exporting All Users on page89.■To import the user record for a selected user from the SD card, see Importing a User on page91.■To import user records for multiple users from the SD card, see Importing All Users on page93.Exporting a UserPerform the following steps to export the user record for a selected user to the SD card:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.NOTE: Only supervisor users can use the reader’s export / import features. If you are logged in as an operator, select Maintenance > Change to Supervisor to export or import information.Supervisor Main Menu Screen
Apex Reader User’s Guide883. Use and to highlight Import / Export and press Select to display the Import / Export screen.4. Use and to highlight Import / Export User and press Select to display the User DB screen.5. Use and to highlight Export User and press Select to display the User DB on Reader screen.The reader displays the user ID, user name, and user mode for all users that have been added, arranged numerically by user ID. You can use and to scroll through user records.Import / Export ScreenUser DB ScreenUser DB on Reader Screen
Export / Import Features896. Use and to highlight the user record you want to export and press Select.A checkmark appears in the box next to the user ID to indicate the selected user.7. Press Export to copy the user information for the selected user to the SD card.The reader displays the Export Successful screen when the user record has been exported to the SD card.8. Press OK to return to the Import / Export screen or press Main Menu to return to the supervisor Main Menu screen.Exporting All UsersPerform the following steps to export multiple user records to the SD card:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.NOTE: To remove the checkmark, highlight the user record and press Select again.Export Successful Screen — UserSupervisor Main Menu Screen
Apex Reader User’s Guide903. Use and to highlight Import / Export and press Select to display the Import / Export screen.4. Use and to highlight Import / Export User and press Select to display the User DB screen.5. Use and to highlight Export all Users and press Select to display the User DB on Reader screen.The reader displays the user ID, user name, and user mode for all users that have been added, arranged numerically by user ID. You can use and to scroll through user records. A checkmark is shown in the box next to each user ID to indicate that all users have been selected to be exported.Import / Export ScreenUser DB ScreenUser DB on Reader Screen
Export / Import Features916. If there is a user record that you do not want to export, use and to highlight the user record. When the user record is highlighted, press Select.The checkmark is removed from the box next to the user ID.7. Repeat Step 6 as necessary.8. When all desired user records are selected, press Export to copy the user information for the selected users to the SD card.The reader displays the Export Successful screen when the user records have been exported to the SD card.9. Press OK to return to the Import / Export screen or press Main Menu to return to the supervisor Main Menu screen.Importing a UserPerform the following steps to import the user record for a selected user from the SD card:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.Export Successful Screen — UserSupervisor Main Menu Screen
Apex Reader User’s Guide923. Use and to highlight Import / Export and press Select to display the Import / Export screen.4. Use and to highlight Import / Export User and press Select to display the User DB screen.5. Use and to highlight Import User and press Select.The user records are read from the SD card and displayed on the User DB on SD Card screen. This screen displays the user ID, user name, and user mode for all user records on the SD card, arranged numerically by user ID. You can use and to scroll through user records.Import / Export ScreenUser DB ScreenUser DB on SD Card Screen
Export / Import Features936. Use and to highlight the user record you want to import. When the desired user record is highlighted, press Select.A checkmark appears in the box next to the user ID to indicate the selected user.7. Press Import to copy the user information for the selected user to the reader.The reader displays the Import Successful screen when the user record has been imported to the reader.8. Press OK to go to the User ID List screen or press Main Menu to return to the supervisor Main Menu screen.Importing All UsersPerform the following steps to import multiple user records from the SD card:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.NOTE: To remove the checkmark, highlight the user record and press Select again.Import Successful ScreenSupervisor Main Menu Screen
Apex Reader User’s Guide943. Use and to highlight Import / Export and press Select to display the Import / Export screen.4. Use and to highlight Import / Export User and press Select to display the User DB screen.5. Use and to highlight Import all Users and press Select.The user records are read from the SD card and displayed on the User DB on SD Card screen. This screen displays the user ID, user name, and user mode for all user records on the SD card, arranged numerically by user ID. You can use and to scroll through user records. A checkmark is shown in the box next to each user ID to indicate that all users have been selected to be imported.Import / Export ScreenUser DB ScreenUser DB on SD Card Screen
Export / Import Features956. If there is a user record that you do not want to import, use and to highlight the user record. When the user record is highlighted, press Select.The checkmark is removed from the box next to the user ID.7. Repeat Step 6 as necessary.8. When all desired user records are selected, press Import to copy the user information for the selected users to the reader.The reader displays the Import Successful screen when the user records have been imported to the reader.9. Press OK to go to the User ID List screen or press Main Menu to return to the supervisor Main Menu screen.Import Successful Screen
Apex Reader User’s Guide96
97Other FeaturesReviewing Reader InformationSupervisor users and operator users can review information about the reader. Some information is only available to supervisor users.■All users can review the version information for the reader’s software. See Checking the Software Version on page97 for instructions.■All users can review a summary of the reader’s settings, including login/logout settings, patient ID settings, and the reader’s serial number. See Reviewing Global Settings on page101 for instructions.■All users can review a listing of actions that have been performed by supervisors. See Reviewing the Supervisor History on page99 for instructions.■Supervisor users can review the results of the last internal check that was performed on the reader. See Reviewing Internal Check Results on page103 for instructions.Checking the Software VersionSupervisor users and operator users can review the version information for the reader’s software. Perform the following steps to check the software version:1. Press to display the Main Menu screen. Supervisor Main Menu Screen Operator Main Menu Screen
Apex Reader User’s Guide982. If you are logged in as a supervisor, use and to highlight Settings and press Select to display the supervisor Settings screen.If you are logged in as an operator, use and to highlight Maintenance and press Select to display the Maintenance screen. 3. If you are logged in as a supervisor, use and to highlight Device Info and press Select to display the Device Info screen.If you are logged in as an operator, use and to highlight Settings and press Select to display the operator Settings screen. 4. Use and to highlight Software Version and press Select to display the Current Software Version screen.The version information for the reader’s software is displayed.Supervisor Settings Screen Maintenance Screen Device Info Screen Operator Settings ScreenCurrent Software Version Screen
Other Features995. Press Back to return to the previous screen or press to return to the Main Menu screen.Reviewing the Supervisor HistorySupervisor users and operator users can review a listing of actions that have been performed by supervisors. Perform the following steps to review supervisor history:1. Press to display the Main Menu screen. 2. If you are logged in as a supervisor, use and to highlight Settings and press Select to display the supervisor Settings screen.If you are logged in as an operator, use and to highlight Maintenance and press Select to display the Maintenance screen. Supervisor Main Menu Screen Operator Main Menu ScreenSupervisor Settings Screen Maintenance Screen
Apex Reader User’s Guide1003. If you are logged in as a supervisor, use and to highlight Device Info and press Select to display the Device Info screen.If you are logged in as an operator, use and to highlight Settings and press Select to display the operator Settings screen. 4. Use and to highlight Supervisor History and press Select to display the Supervisor History screen.The reader displays the user ID, date, time, and action identifier for actions that have been performed by supervisor users. You can scroll through actions using and . AG: CAN WE GET A KEY FOR SUPERVISOR ACTIONS?5. If you want to print the supervisor history, press Print.6. Press Back to return to the previous screen or press to return to the Main Menu screen. Device Info Screen Operator Settings ScreenSupervisor History Screen
Other Features101Reviewing Global SettingsSupervisor users and operator users can review a summary of the following reader settings:■Logout Time: The logout time setting is the duration of inactivity after which a user will be automatically logged out of the reader. For instructions to change the logout time, see Changing Security and Power Saving Settings on page44.■APO Time: The automatic power off time is the duration of inactivity after which the reader will automatically turn off. For instructions to change the automatic power off time, see Changing Security and Power Saving Settings on page44.■Auto Login: The auto-login setting determines whether users are required to enter a login and PIN to use the reader. For instructions to change the auto-login setting, see Changing Security and Power Saving Settings on page44.■Immediate Print: The immediate print setting determines whether test results are printed automatically upon completion of a patient test. For instructions to change printing setup, see Changing the Print Setting on page43.■Manual Patient ID: The manual patient ID setting determines whether patient IDs can be input by manual entry. For instructions to change the manual patient ID setting, see Changing Patient ID Settings on page40.■External Barcode Reader: The manual patient ID setting determines whether patient IDs can be input by an external barcode reader. For instructions to change the external barcode reader setting, see Changing Patient ID Settings on page40.■Cutoff: The cutoff setting is the minimum test result that will be considered positive when the reader tests a patient sample. AG: CONFIRM THAT THIS SETTING WILL BE AVAILABLE.■Serial Number: The serial number for the reader is available on this screen.■Language: The language setting determines what language is displayed on the reader screen and printouts. For instructions to change the language, see Changing the Language on page39.NOTE: Operator users cannot modify these settings.
Apex Reader User’s Guide102Perform the following steps to review global settings:1. Press to display the Main Menu screen. 2. If you are logged in as a supervisor, use and to highlight Settings and press Select to display the supervisor Settings screen.If you are logged in as an operator, use and to highlight Maintenance and press Select to display the Maintenance screen. 3. If you are logged in as a supervisor, use and to highlight Device Info and press Select to display the Device Info screen.If you are logged in as an operator, use and to highlight Settings and press Select to display the operator Settings screen. Supervisor Main Menu Screen Operator Main Menu ScreenSupervisor Settings Screen Maintenance Screen Device Info Screen Operator Settings Screen
Other Features1034. Use and to highlight Global Settings and press Select to display the Global Settings screen.The reader’s current settings are displayed. You can scroll through settings using and . 5. If you want to print the global settings, press Print. 6. Press Back to return to the previous screen or press to return to the Main Menu screen.Reviewing Internal Check ResultsSupervisor users can review the results of the last internal check that was performed on the reader. Perform the following steps to review the internal check results:1. Press to display the supervisor Main Menu screen. Global Settings ScreenNOTE: Only supervisor users can use this feature. If you are logged in as an operator, select Maintenance > Change to Supervisor to review internal check results.Supervisor Main Menu Screen
Apex Reader User’s Guide1042. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight Device Info and press Select to display the Device Info screen.4. Use and to highlight Show Int. Check Results and press Select to display the stored Internal Check Result screen.The reader displays the results of the last internal check that was performed.5. Press Back to return to the Device Info screen or press to return to the Main Menu screen.Supervisor Settings ScreenDevice Info ScreenStored Internal Check Result Screen
Other Features105Checking Ambient TemperatureSupervisor users can check the ambient temperature detected by the reader. Perform the following steps to check the temperature:1. Press to display the supervisor Main Menu screen.2. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight Read Temperature and press Select to display the Temperature screen.The current temperature is displayed.NOTE: Only supervisor users can use this feature. If you are logged in as an operator, select Maintenance > Change to Supervisor to check the temperature.Supervisor Main Menu ScreenSupervisor Settings ScreenTemperature Screen
Apex Reader User’s Guide1064. Press Back to return to the supervisor Settings screen or press to return to the supervisor Main Menu screen.Deleting Stored Test ResultsSupervisor users can delete test results stored in the reader’s memory.Perform the following steps to delete stored test results:1. Press to display the supervisor Main Menu screen.2. Use and to highlight Settings and press Select to display the supervisor Settings screen.NOTE: Only supervisor users can use this feature. If you are logged in as an operator, select Maintenance > Change to Supervisor to delete results.Supervisor Main Menu ScreenSupervisor Settings ScreenIMPORTANT: Test results cannot be retrieved from the reader after they are deleted. Before you delete any test results, make sure that you have archived the results appropriately.
Other Features1073. Use and to highlight Delete Results and press Select to display the Delete Results screen.The reader displays the patient ID, date, time, and test result for all results stored in the reader’s memory, starting with the most recent test performed. You can scroll through results using and .4. Use and to highlight the result you want to delete and press Options a to display the Result List Options screen.5. To delete only the selected result:a. Use and to highlight Delete Result and press Select.b. The reader displays the Delete Results confirmation screen to inform you that the selected results have been deleted.6. To delete all patient results stored in the reader’s memory:a. Use and to highlight Delete All and press Select.b. The reader displays the Delete Results confirmation screen to inform you that the selected results have been deleted.Delete Results ScreenResult List Options Screen — Delete Results
Apex Reader User’s Guide1087. To delete all positive results stored in the reader’s memory:a. Use and to highlight Delete pos and press Select.b. The reader displays the Delete Results confirmation screen to inform you that the selected results have been deleted.8. To delete all negative results stored in the reader’s memory:a. Use and to highlight Delete neg and press Select.b. The reader displays the Delete Results confirmation screen to inform you that the selected results have been deleted.9. Press OK to return to the Delete Results screen or press to return to the supervisor Main Menu screen.Delete Results Confirmation Screen
Other Features109Resetting the Reader to Default SettingsSupervisor users can reset the reader to its default settings. Perform the following steps to reset the reader settings:1. Press to display the supervisor Main Menu screen.2. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight Reset to Default and press Select to display the Reset to Default confirmation screen.4. Press Reset to reset the reader’s settings or press Cancel to retain the current settings and return to the supervisor Settings screen.NOTE: Only supervisor users can use this feature. If you are logged in as an operator, select Maintenance > Change to Supervisor to reset the reader settings.Supervisor Main Menu ScreenSupervisor Settings ScreenReset to Default Confirmation Screen
Apex Reader User’s Guide110Using the Barcode Reader AccessoryThe reader kit may include a barcode reader accessory that can be used to enter information.To use the barcode reader, connect it to the reader by inserting the end of the cable into the PS/2 port in the back of the reader. You can now use the barcode reader to enter patient IDs and user IDs.Connecting the Barcode Reader
111Care & MaintenanceMaintaining the ReaderStandard maintenance activities for the reader, which can be performed by an operator, include:■periodically cleaning the exterior of the reader (see page 111)■changing the paper (see page 111)■replacing the batteries (see page 113)Other maintenance activities that might be performed on occasion and can only be performed by a supervisor include:■changing the date and time (see page 115)■updating languages available in the reader (see page 118)■upgrading the reader software (see page 121)If any other service or maintenance is required, the reader should be sent to the manufacturer. See Returning the Reader on page126.Cleaning the ReaderThe reader requires minimal maintenance. Occasional cleaning of the exterior is usually sufficient. If blood or other fluids are not allowed enough time to fully absorb into test devices, the reader drawer may occasionally require cleaning. Use a damp, not wet, lint-free cloth to apply a 70% ethanol solution on the outside of the reader or to the inside of the reader drawer.Do not allow water to seep into the printer. Do not immerse the reader in water or other liquids.If the Apex Reader is moved or returned for replacement or repair, the reader should be cleaned prior to transfer.Changing the PaperYou can change the paper in the reader anytime. If the reader runs out of paper while in the middle of a printing task and displays the Empty Paper Tray message, the paper may be changed and the print job restarted.NOTE: Never insert any tools, swabs, or cleaning materials into the reader drawer.
Apex Reader User’s Guide112Perform the following steps to change the paper:1. Remove the printer cover by pulling up the blue handle on the top of the cover.2. Remove the empty paper spindle and any unused paper.3. If necessary, tear or cut the end of the new paper roll to form a straight edge. Then insert the paper roll in the printer so that the end of the paper comes from under the roll toward the reader display, as shown below.Removing the Printer CoverInserting the Paper Roll
Care & Maintenance1134. To replace the printer cover, insert the paper roller between the edge of the paper and the paper roll, as shown below. Then push down on the sides of the printer cover until you hear it snap into place.5. Press .The reader feeds the paper so that it extends out the top of the printer.If a print job was interrupted, you need to restart this print job.Replacing the Printer Cover
Apex Reader User’s Guide114Replacing the BatteriesAG: CONFIRM ALL. The battery power level is indicated by the icon displayed at the top right of the reader screen. The battery icon is gradually filled with white as the batteries are discharged. Perform the following steps to replace the batteries in the reader:1. Turn the reader off by pushing the on/off switch up, then releasing it.2. Turn the reader over so that the back of the battery cover is visible.3. To remove the battery cover, place your thumb in the middle of the cover and exert slight pressure as you slide it in the direction shown below.4. Remove the old batteries and discard them in an appropriate waste container.IMPORTANT: The reader is designed to perform and print at least 50 tests before replacement batteries are required. If you are using batteries to power the reader, it should be turned off when not in use. You can use the automatic Power Off Time setting to help preserve battery life.IMPORTANT: Rechargeable batteries are authorized for use with the reader. However, due to the nature of these types of batteries, it is expected they will require recharging more frequently. The reader does not contain a built-in battery charger, and rechargeable batteries must be recharged outside of the reader.
Care & Maintenance1155. Insert four size AA 1.5 volt batteries. Be sure that the plus (+) and minus (-) signs on the batteries match the signs embossed in the battery compartment.6. Replace the battery cover by positioning it at the edge of the battery compartment as shown and sliding it into position.7. When you have completed battery installation and replaced the battery cover, turn the reader right side up. Changing the Date and TimePerform the following steps to change the reader’s date and/or time:1. Press to display the supervisor Main Menu screen.Installing the BatteriesIMPORTANT: If the reader does not power on after replacing the batteries, verify that the batteries are lined up according to the symbols in the battery compartment.NOTE: Only supervisor users can use this feature. If you are logged in as an operator, select Maintenance > Change to Supervisor to change the reader’s date and time.Supervisor Main Menu Screen
Apex Reader User’s Guide1162. Use and to highlight Settings and press Select to display the supervisor Settings screen.3. Use and to highlight Set Date and Time and press Select to display the Set Date screen.4. When the Set Date screen is first displayed, the Date format field is highlighted. Use and to scroll through the following options for how to display dates on the reader screen and printouts:■dd.mm.yyyy: Select this option to display the day, then the month, then the year with periods used as separators.■mm/dd/yyyy: Select this option to display the month, then the day, then the year with slashes used as separators.■yyyy/mm/dd: Select this option to display the year, then the month, then the day with slashes used as separators.When the preferred date format is displayed, press to highlight the Year field.5. Use or to increment or decrement the year.When the correct year is displayed, press to highlight the Month field.Supervisor Settings ScreenSet Date Screen
Care & Maintenance1176. Use or to increment or decrement the month.When the correct month is displayed, press to highlight the Day field.7. Use or to increment or decrement the day.When the correct day is displayed, review the date format, year, month, and day, and confirm that the correct date information is displayed. If you need to change a setting, use and to highlight the field. Then use and to make the necessary changes.8. When you have confirmed that the correct date is displayed, press Confirm & Next to display the Set Time screen.9. When the Set Time screen is first displayed, the Time format field is highlighted. Use and to toggle between the following options for how to display times on the reader screen and printouts:■12h: Select this option to display times in the 12 hour time format with am and pm.■24h: Select this option to display times in the 24 hour time format.When the preferred time format is displayed, press to highlight the Hour field.10. Use or to increment or decrement the hour.When the correct hour is displayed, press to highlight the Minute field.11. Use or to increment or decrement the minute.When the correct minute is displayed, review the time format, hour, and minute and confirm that the correct time information is displayed. If you need to change a setting, use and to highlight the field. Then use and to make the necessary changes.Set Time Screen
Apex Reader User’s Guide11812. When you have confirmed that the correct time is displayed, press Confirm to save the selected time and date settings and return to the supervisor Settings screen.Updating Reader LanguagesThe reader’s language setting determines what language is displayed on the reader screen and printouts. Supervisor users can add new language selections to the reader by importing them from an SD card. Perform the following steps to update the reader languages:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.3. Use and to highlight Import / Export and press Select to display the Import / Export screen.NOTE: Only supervisor users can use this feature. If you are logged in as an operator, select Maintenance > Change to Supervisor to update the reader languages.Supervisor Main Menu ScreenImport / Export Screen
Care & Maintenance1194. Use and to highlight Import Language and press Select to display the Existing Languages screen.This screen displays all languages currently available on the reader. You can scroll through the available languages using and .5. Press Import new to import a new language from the SD card.The new languages are read from the SD card and displayed on the Languages on SD Card screen. You can scroll through the new languages using and .6. Use and to highlight the language you want to import.Existing Languages ScreenLanguages on SD Card Screen
Apex Reader User’s Guide1207. When the desired language is highlighted, press Import.■If the reader’s language database has room for this language, the reader imports the new language and displays the Import Successful screen. If this screen appears, go to Step 12.■If the reader’s language database does not have room for this language, the Insufficient Memory screen is displayed. If this screen appears, you will need to replace an existing language on the reader with the new language.8. Press OK to display the Replace Language screen.This screen displays the languages currently available on the reader. You can scroll through the available languages using and .Import Successful ScreenInsufficient Memory ScreenReplace Language Screen
Care & Maintenance1219. Use and to highlight the current language you want to replace with the new language.10. When the desired language is highlighted, press Replace.11. The reader imports the new language and displays the Import Successful screen.12. Press OK to return to the Existing Languages screen or press to return to the supervisor Main Menu screen.13. To change reader’s language setting, see Changing the Language on page39.Upgrading the Reader SoftwareSupervisor users can upgrade the reader’s software by importing the new software from an SD card. Perform the following steps to upgrade the reader software:1. Install the SD card in the reader. For instructions, see page 83.2. Press to display the supervisor Main Menu screen.Import Successful ScreenNOTE: Only supervisor users can use this feature. If you are logged in as an operator, select Maintenance > Change to Supervisor to upgrade the reader software.Supervisor Main Menu Screen
Apex Reader User’s Guide1223. Use and to highlight Import / Export and press Select to display the Import / Export screen.4. Use and to highlight Upgrade Software and press Select to display the Software upgrade available screen.This screen displays the version information for the reader’s current software and the version of software available on the SD card.5. Press Upgrade to upgrade the reader’s software.The reader performs the upgrade, then shuts down and restarts. AG: CONFIRM. To confirm that the software was upgraded, see Checking the Software Version on page97.Import / Export ScreenSoftware Upgrade Available Screen
Care & Maintenance123TroubleshootingTroubleshooting TipsRefer to the table below for instructions for troubleshooting problems.Problem Condition Corrective ActionsPaper jam 1. Remove the printer cover to reveal the paper compartment.2. Remove the paper roll and reinsert it so that the end of the paper comes from under the roll toward the reader display.3. Replace the printer cover.4. Press to advance the paper.5. If the error continues, contact Technical Support for assistance.Keypad or other keys do not work Reset the reader by disconnecting the AC power adapter from the reader or removing the four batteries. Wait 30 seconds and reconnect the power adapter or reinsert the batteries.Reader will not turn on Ensure that the AC power adapter is connected securely to the reader and to the power outlet or that the four batteries are installed correctly. If the problem continues, connect the AC power adapter to a different power supply or replace the four AA batteries with all new batteries.Reader is locked up Reset the reader by disconnecting the AC power adapter from the reader or removing the four batteries. Wait 30 seconds and reconnect the power adapter or reinsert the batteries.Drawer / test cartridge is jammed Do not pull or force the drawer/test cartridge out of the reader. Reset the reader by disconnecting the AC power adapter from the reader or removing the four batteries. Wait 30 seconds and reconnect the power adapter or reinsert the batteries.If you are still unable to open the drawer and/or remove the test cartridge, contact Technical Support.
Apex Reader User’s Guide124Understanding Error MessagesRefer to the table below for instructions for responding to error messages. AG: CONFIRM THIS LIST IS COMPLETE AND PROVIDE ANY ADDITIONAL RECOMMENDATIONS.Error Message Corrective ActionBarcode Scan Failed Attempt to read the barcode again.If the problem persists, check the connection to the barcode reader.Battery Low Replace the reader’s 4 AA batteries or connect the AC power adapter. Try again to print.Battery Too Low Replace the reader’s 4 AA batteries or connect the AC power adapter.Empty Paper Tray Replace the paper roll in the reader.Expired Cartridge Remove the expired test cartridge and repeat the test with a new test cartridge.ID Already Exists The selected user ID is already in use. Enter a different 4-digit user ID.Invalid One Shot PIN The entered PIN is invalid. Try again to enter the one shot PIN that was provided.If the problem persists, contact Technical Support to obtain a new one shot PIN.Invalid Patient ID The patient ID must be 1 to 15 digits. Try again to enter the patient ID.Invalid User ID The user ID must be 4 characters. Try again to enter the user ID.LAN Error (Cannot Get IP Address) The DCHP server is not responding with an IP address. Contact your network administrator for assistance.LAN Error (Network Cannot Be Configured)The network connection cannot be configured. Contact your network administrator for assistance.LIS Error (LIS Connection Interrupted)The connection to the LIS was interrupted. Try the operation again.LIS Error (LIS Connection Not Available)The reader failed to connect to the LIS. Try again to establish the connection. If the problem persists, check the network settings or contact your network administrator for assistance.
Care & Maintenance125LIS Error (Reviewer Not Available) The LIS is currently unavailable. Try again to establish the connection. If the problem persists, contact your network administrator.Login Failed The user ID / PIN combination is invalid. Try again to log in.Multiple ID Tags Detected Ensure that only one RFID tag is on or near the reader.No Control Line Found Remove the test cartridge and repeat the test with a new cartridge.No ID Tag Detected Place the RFID on the designated area of the reader and try again.No SD Card Found Make sure a valid SD card is properly inserted in the reader.No Upgrade Available No software upgrade was found on the SD card. Make sure a valid SD card with a software upgrade is properly inserted in the reader.PIN Mismatch The confirmed PIN must match the entered PIN.Printer Temperature High The printer temperature is too high for printing. Allow the printer to cool off and try again to print.RFID Error There was an error during RFID communication. Try again. If the problem persists, move the reader away from possible sources of RF interference.SD Card Read Error The SD card may be wrong type or may be damaged. Make sure a valid SD card is properly inserted in the reader.SD Card Write Error The SD card may be wrong type or may be damaged. Make sure a valid SD card is properly inserted in the reader.Temperature Error The ambient temperature is outside the measurement range of the reader (15°C to 30°C).Too Many Users Selected The user database is full. To import more users, you must first delete existing users.Used Cartridge Remove the test cartridge and repeat the test with a new cartridge.Error Message Corrective Action
Apex Reader User’s Guide126Quality AssuranceAG: PROVIDE A QUALITY ASSURANCE STATEMENT.Returning the ReaderAG: PROVIDE INSTRUCTIONS FOR RETURNING THE READER.Disposing of the ReaderIn conformance with the WEEE (Waste Electrical and Electronic Equipment) Directive, do not dispose of this product in municipal waste. Please contact Aspen BioPharma to arrange disposal and recycling.
127GlossaryAssay Test to determine the presence of a substance.Barcode reader Scanning device that can interpret a barcode, which is a series of vertical bars of varying widths that each represent a digit from 0 to 9.Calibration Process of checking the accuracy of a measuring instrument by comparison of a result to a reference standard.Internal QC Quality controls built into the reader’s software and / or the test cartridge.Operator user User with operator access privileges, which allow performance of day-to-day operations with the reader.QC Quality control. QC refers to steps taken to make sure that a system is of sufficiently high quality.Reader The .Reagent Chemical substance that is used to create a reaction when combined with another substance for the purpose of analysis.RFID Radio frequency identification; a data collection technology that uses electronic tags for storing data and allows automatic identification of items. Unlike barcode technology, RFID provides ‘out of line of sight’ identification and operates at distances much greater than those at which barcode readers operate.SD card Secure digital memory card. An SD card is a small flash memory card used for portable storage of digital data that can be imported to and exported from the reader.Supervisor user User with supervisor access privileges, which allow performance of advanced reader activities.Test cartridge Item that holds the sample (for example, blood) from the patient so it can be inserted into the reader for testing. The test cartridge contains reagent that reacts with blood so that the reader can determine the level of specific chemical substances in the patient.Apex Reader

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