epoc® Blood Analysis System Administrator Guide

2

Table of ContentsInitial 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

3

Initial Setup

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 configuredon 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 berepeated for all Hosts

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

4

Administrator Options

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

5

System Overview

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

6

System Overview

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.”

7

System Overview

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

8

System Overview

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

9

System Overview

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

10

Data Manager Options

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

11

Barcode 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

12

Personal 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.

13

Card 1 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 whenrunning a test

4. Select Save

14

System Overview

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

15

System Overview

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

16

System Overview

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

17

System Overview

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.

18

Card 2 Options

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.

19

System Overview

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 enforcea 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 QAschedule 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

20

Date, Time, and Time Zone Settings

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.

21

Host Information

Host Information

Access Host information by selecting Help > About

1. The first tab displays the current versions and configurations for that Host

2. The second tab displays the test counts sent to that Host

3. The third tab displays information about the Host’s Wi-Fi and Bluetooth connectivity

4. The fourth tab displays Host, Reader, and Sensor configuration versions that are available for upgrade from this Host

22System Overview

Reader Configuration

1. To access Reader Configurations select and hold on desired Reader and select Configure

2. The first tab allows the User to name and create a PIN to access the Reader

• If a Reader PIN is changed and misplaced, it is impossible to retrieve the new PIN to communicate with the Reader

3. The second tab allows the user to upgrade the Reader with the latest configurations from the Host

Reader Configuration

23System Overview

Reader Information

To access Reader Information select and hold on the Reader and select Status

1. The first tab displays General status information

2. The second tab displays Hardware status information

3. The third tab displays Processor status information

4. The fourth tab displays the QA status information

Reader Information

24

System Overview

Reader Information

Dedicating Readers

Dedicated Readers will always display on the main Readers screen regardless of whether they are turned on or not

• Dedicated Readers appear with a Lock icon beside the Reader

1. To dedicate a Reader select and hold on a Reader and select Dedicate

2. To undedicated a Reader select and hold on a dedicated Reader and select Undedicate

25

Record Administration

Test Record Administration

1. Select the icon on the toolbar

2. Select View Test. A list of all tests sent to the Host displays

3. Select the Filter icon to filter by PatID/Lot #

4. Select and hold a test record to display additional options

• Remove this test: permanently deletes the Test Record

• Mark as unsent: resends the selected Test Record to the Data Manager upon next synchronization

• Select all: selects all test records displayed

26

Electronic QC Record Administration

1. Select the icon on the toolbar

2. Select View EQC. A list of all EQC tests sent to the Host displays

3. Select and hold a test record to display additional options

• View this record: displays detailed information about that record

• Print this record: allows administrator to print that record

• Remove this record: permanently deletes record from the list

27

Software and eVAD Updates

Software and eVAD Updates

Siemens Healthineers releases updated epoc System software and electronic Value Assignment Datasheets (eVADs) several times per year. An eVAD file is a single file stored on the epoc Host that contains all current ranges and expiration dates for all valid quality control (QC) fluids, calibration verification (CV) fluids, and sensor configuration versions.

Third Party Data Mangers

Consult your Data Manager provider for instructions for performing firmware upgrades to configured Point of Care devices. Software upgrade and eVAD update files for the epoc Host are available from Siemens Document Library.

Siemens Healthineers Data Managers (POCcelerator™, UniPOC™)

Users that employ UniPOC or POCcelerator as a data management option will require assistance from Siemens to update both the epoc System software and eVADs. Additional information can be found in the POCcelerator™ Configuration Manual for epoc Reader/Host and UniPOC™ Configuration Guide for epoc Reader/Host, available from Siemens Document Library.

No Data Manager Present

Follow the instructions found in the bulletin How to Update epoc Host Software and eVAD File to perform software upgrades and eVAD updates for the epoc Host, available from Siemens Document Library.

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02-2021 | All rights reserved© 2021 Siemens Healthcare Diagnostics Inc.

Note: This document is for supplemental use only, and notmeant to be used in place of primary technical materials.

This resource guide, and the software described within, are copyrighted. No part of this may be copied, reproduced, translated, or reduced to any electronic medium or machine-readableform without the prior written consent of SiemensHealthcare Diagnostics, Inc.

T20001.002 Effective date 02/15/2021

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