epoc Administrator Guide

Table of Contents Initial Setup...3 Administrator Options...4 Data Manager Options...10 Barcode Options...11 Personal Options...12 Card options 1...13 Card options 2...18 Date, Time, Time Zone Settings...20 Host Information...21 Reader Configuration...22 Reader Information...23 Record Administration...25 Software and eVAD Updates...27

T20001.002 | Effective date: 02/15/2021 02-2021 | © Siemens Healthcare Diagnostics Inc., 2021

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Initial Setup Please reference the epoc® Host Quick Start Guide (found in original packaging) to perform the initial setup for the epoc Host This includes: • Powering on the Host • Logging in as an administrator • Connecting the Host to Wi-Fi • Connecting the Host to a Data Manager (if present) • If a data manager is present, the Host Administration is performed using your data manager. All Host Administration options configured on the data manager will be transferred to each Host every time it is synchronized. • If NOT connecting to a Data Manager, all Host Administration must be repeated for all Hosts

Note: The epoc® Host Quick Start Guide can be found on Siemens Healthineers Document Library

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Initial Setup

Administrator Options Administrator Options: Tools > Options > Admin Options 1. Page tabs 2. Save • Saves any changes made 3. Exit/Cancel • If selected without first saving, a warning will appear

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Administrator Options

Administrator Options Identification and Language Page 1. Enter Hospital name for the facility 2. Enter Host name for the Host device 3. Select Change Language to choose the language displayed on the Host 4. Select Save

System Overview

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Administrator Options General Configuration Page 1. Select Authentication level required for Login/Run tests and View tests 2. Select the option to Save raw data to save additional test data for troubleshooting (retrievable only by authorized epoc® personnel) 3. Select Allow use of expired cards, if desired for training purposes only 4. Select Enable FIPS mode in accordance with facility Wi-Fi network infrastructure 5. Select Close completed tests after 15 min to automatically disconnect Host from Reader after 15 minutes of inactivity 6. Select Allow user to reject test to enable users to reject tests during sample analysis 7. Select Save

Note: “Recommended setting for Save raw data is On Failure. Select Always only when requested to do so by authorized personnel to troubleshoot epoc System performance problems.”

System Overview

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Administrator Options Patient and Security Page 1. Select Fixed length patient ID to set a length for the Patient ID field (1-23 characters) 2. Select the drop down menu for Temperature units to select Fahrenheit (F) or Celsius (C) and Height units in inches or centimeters 3. Select the checkbox Automatic log out after inactivity to enable. Select the dropdown menu to select a time interval to automatically log out a user from the Host 4. Select the checkbox Automatic log out after power off to automatically log out a user from the Host when the power button is pressed 5. Select the drop down menu for Action when closing test to select an automatic Host action to perform after a test has been closed 6. Select Enable background synchronization to enable the Host to send unsent test results to the Data Manager after each completed test 7. Select Retain patient ID/sample type between tests to enable the Host to recall the previously entered patient ID/sample type when a new test card is inserted 8. Select Save System Overview

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Administrator Options User Accounts Page 1. Select Load users 2. Select Add 3. Enter User ID 4. Enter Name 5. Enter Password (case sensitive, must be at least 4 characters) 6. Select the drop down menu for Expiration to set the expiration date of the user 7. Select Allow user to run QA tests if desired 8. Select Allow user to upgrade Host if desired 9. Select Add 10. Select OK 11. Select Save

Note: Administrator account is not shown in the dropdown

System Overview

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Administrator Options Printer Set Up Page 1. Select Add 2. Enter Name of printer 3. Enter a Bluetooth, or IP address for the printer in the Address field 4. Select Print calculated results 5. Select Print corrected results 6. Select Print test info 7. Select the drop down menu for Printer type to select a printer 8. Select Bluetooth or Wi-Fi for the printer connection 9. Once a printer is configured, select Print test page to test your printer connection 10. Select Save

Note: A list of all authorized printers can be found in Section 13 of the epoc® System Manual

System Overview

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Data Manager Options 1. Select Tools > Options > DM options 2. Select Yes or No if the use of a Data Manager is required 3. Enter the Data Manager’s IP address or server name 4. Enter the Port Number for the Data Manager server location 5. Select Test Connection 6. Select Save

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Data Manager Options

Barcode Options 1. Select Tools > Options > Barcode options 2. Select the icon for 1D barcode options or 2D barcode options 3. Select the drop down menu for Field type to configure the barcode options for each field type that is barcode enabled 4. Enter a number in the Crop begin and Crop end fields to remove digits from the beginning or end of scanned barcodes 5. Select the check box(es) for the appropriate barcode type according to facility policy 6. Select Save

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Barcode Options

Personal Options If desired, the administrator user password can be changed. 1. Select Tools > Options > Personal options 2. Enter the Old password 3. Enter the New password 4. Enter the new password again in the Verify field 5. Select Save

Note: This page is not available if the Host is connected to a Data Manager. In this case the administrator can change the password using the Data Manager.

Note: The Administrator should change the password after logging in for best security practices. Retain the New Password in a secure location. The Administrator cannot access the Administrator Account if the Administrator password is changed and subsequently misplaced and forgotten. Contact Siemens Healthineers Remote Services Center for a temporary password if the Administrator Password was changed and is no longer available for use.

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Personal Options

Card options 1 Sample type Selection Page 1. Select Tools > Options > Card 1 options 2. Select which sample types will be run by the Host and Readers 3. Check the box at the top of the page to make selecting a sample type a requirement when running a test 4. Select Save

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Card 1 Options

Card options 1 Test Selection Settings Page 1. Select the check boxes next to each assay to choose testing defaults when running a test • Enabled: the analyte is available to obtain results when running a test • Selected: the analyte will be selected and produce a result by default when running a test • Enabled/Not Selected: the analyte is available to obtain a result but the User must manually select it during testing to produce a result 2. Select Save

Note: When running a QA test, all enabled analytes will be selected by default

System Overview

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Card options 1 Units and Reportable Ranges Page 1. Use the dropdown menus next to each analyte to select what units the analyte will be reported with 2. Input the lower and upper reportable ranges for the analyte in the Low and High fields next to each analyte 3. Results falling outside of the reportable ranges for an analyte will be listed as “<low report limit” or “>high report limit” 4. Custom reportable ranges may not exceed the measurement range of the BGEM test cards (section 12 in the epoc® System Manual) 5. Select Save

System Overview

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Card options 1 Reference Ranges Settings Page 1. Select the appropriate sample type from the dropdown menu 2. Input the Low and High reference ranges for the facility in the Low and High fields next to each analyte • Results falling outside of the reference range will be marked with a or 3. If 2 different sample types have the same reference ranges, use the Transfer button to copy the reference ranges from one sample type to another 4. Select Save

System Overview

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Card options 1 Critical Ranges Settings Page 1. Select the appropriate sample type from the dropdown menu 2. Input the Low and High critical ranges for the facility in the Low and High fields next to each analyte • Results falling outside of the critical range will be marked with a or 3. If 2 different sample types have the same critical ranges, use the Transfer button to copy the critical ranges from one sample type to another 4. Select Save

Note: The default Critical Ranges are factory set to values outside the Reportable Ranges. To use Critical Ranges the Administrator must narrow them down to the desired critical values.

System Overview

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Card options 2 Edit Test Settings Page 1. Access Card 2 Options by selecting Tools > Options > Card 2 options 2. Use the drop down menu for Apply hemodilution to select when to correct hematocrit results for the amount of hemodilution in a patient sample 3. Select the Print options to control what gets automatically printed when running a test (only if Host is connected to a printer) 4. Select Enforce critical handling to display the Critical Actions button when a critical result is obtained 5. Select Additional documentation to enable the Additional Documentation Clipboard button to record additional test information during sample analysis 6. Select Allow data recall on incomplete test to automatically recall all test information if the previous test fails 7. Select Save Note: Hemodilution is used to correct hematocrit results for patients undergoing cardiopulmonary bypass, ECMO, or patients receiving large amounts of IV fluids. Please see section 12.13 in the epoc System Manual for more information.

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Card 2 Options

Card options 2 Scheduling and Lockout Settings Page Before activating this option, please ensure the electronic Value Assignment Datasheet (eVAD) is installed on the epoc Host. 1. Select the Schedule type dropdown menu to enforce a schedule for a QA test 2. Select the Verification type dropdown menu to determine how the Host will enforce the schedule • Lock: the Host will lock so no testing can continue until the proper QA requirements are met • Ask: the Host will inform the User that the Host’s QA schedule has expired and will ask if the User wants to proceed • Disabled: the Host will not enforce any schedule for that QA test 3. Select Save

Note: All QA testing must be completed before enabling QA schedules or the Hosts may lock unexpectedly

System Overview

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Date, Time, and Time Zone Settings 1. Access date and time settings by selecting Tools > Set date/time 2. Select the correct date from the Date dropdown menu 3. Set the correct time using the arrows listed next to Time 4. Select the correct time zone from the Time Zone dropdown menu 5. Select OK

Note: A data manager updates Date and Time in the epoc Host during synchronization. Any changes made on the Host will be overwritten during synchronization.

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Date, Time, and Time Zone Settings