Atellica® Solution Essentials

Atellica® Solution

EssentialsVirtual Training Workbook

i Atellica Solution T18001.044 Effective Date: 04/19/21

Siemens Healthineers

Atellica Solution Essentials Virtual Training Workbook

ii Atellica Solution

©2021 Siemens Healthineers. All rights reserved.

Welcome

Atellica Solution 1-1

1 Welcome

Welcome to Training

Siemens Healthineers would like to welcome you to training on the Atellica® Solution. This course is designed

to teach you the skills needed to operate and maintain the Atellica Solution. Our staff welcomes the

opportunity to present this training program to you.

Training Material

This training workbook includes an agenda, learning objectives, and practical exercises.

Welcome

1-2 Atellica Solution

Atellica Solution Essentials Virtual Training

Course Objectives

Upon completion of the class, you will be able to:

• Identify the system components and their functions

• Navigate the software

• Utilize the Maintenance Schedule

• Manage supplies, system fluids and reagents

• Utilize the instrument Online Help, PEPconnect, and Document Library

• Monitor sample status

• Determine the QC material needs

• Describe how the system utilizes reagent lot and pack calibration intervals to determine calibration frequency

• Determine the calibration material that need to be loaded on the system

• Review calibration results

• Utilize the Operator Event Log

Welcome


Atellica Solution Essentials Virtual Training

Agenda

• Hardware and Software Overview

• Maintenance Overview

• Reagent and Supply Management

• Document Library and PEPconnect

• Monitoring Samples and Quality Control

• Calibration

• Troubleshooting

Welcome


Atellica® Solution Essentials Virtual Training

Course Validation Checklist The participant places a checkmark beside the competency when it is completed. When all competencies are checked, the instructor and participant sign and date below as record of completion.

Instructor: ________________________________________________________________________

Participant: ________________________________________________________________________

Date: ________________________________________________________________________

What was most helpful to you during this program?

How can we improve this program to make it more meaningful to you?

Topics Competencies Completed

System Components Identify the system components and their functions

Software Navigate the Command Bar, Workspace, and Status Bar

Sign into and out of the User Interface and Operator Tablet

Access PEPconnect and Document Library

Utilize On-Line Help

View and acknowledge System Alerts

Check System Health

Maintenance Utilize the Maintenance Schedule

Reagent and Supply Management

Monitor the status of the supply and reagent inventories

Loading Samples and Quality Control

Monitor Sample Status

Determine Quality Control materials needed

Calibration Describe how the system utilizes reagent lot and pack calibration intervals to determine calibration frequency

Determine the calibration material that needs to be loaded on the system

Review calibration results

Troubleshooting Utilize the Operator Event Log

System Components


2 System Components

System Components


System Components

Resources • Online Help

• PEPconnect

Objective Upon completion of this exercise you will be able to identify the system components and their functions for the:

• Sample Handler (SH)

• Chemistry module (CH)

• Immunoassay module (IM)

System Components


SH System Components

1. Identify the following SH components in the image below

__A__ Visual status light __D___ Lock/unlock drawer buttons

__B__Monitor, keyboard, and mouse __E___ Sample drawers

__C__ System front cover __ F___ Process Center Computer (PCC)

A

C

B D

E

F

System Components


SH System Components

2. Identify the following SH system components in the images below

__A__ Robotic arm

__B__ Cal-QC Storage area

__C__ Tube Characterization System (TCS)

__D__ Carrier

__E__ Atellica MaglineTM Transport

D

A C

B

E

System Components


CH System Components

3. Identify the following CH system components in the image below

__A__ System front cover

__B__ IMT (integrated multisensor technology) fluids lid

__C__ Reagent tray lid

__D__ Module Display

__E__ Atellica Magline™ Transport

__F__ System fluid drawer

__G__ Water and liquid waste

D E

F G

B C

A

System Components


CH System Components

4. Identify the following CH system components in the image below

__A__ IMT __D__ Reagent probes 1 and 2

__B__ Sample Probe __E__ Reagent compartment

__C__ Reaction ring __F__ Reagent tray

__G__ Dilution Probe

__H__ Dilution Ring

__I__ Dilution Mixer

__J__ Dilution Washer

A

D

C

B

E

F

G

I

H

J

System Components


IM System Components 5. Identify the following IM system components in the image below

__A__ System front cover

__B__ Sample tip loading lid

__C__ Cuvette bin lid

__D__ Reagent drawer

__E__ Water and liquid waste drawer

__F__ System fluid drawer

__G__ Solid waste drawer

A

E G

D

B

C

F

System Components


IM System Components 6. Identify the following IM system components (front) in the image below

__A__ Sample tip loader

__B__ Wash ring

__C__ Luminometer

__D__ Cuvette bin

D

C

A

B

System Components


7. Identify the following IM system components (rear) in the images below

__A__ Reagent Loader __D__ Reagent probes

__B__ Reagent Compartment __E__ Sample probe

__C__ Incubation ring

E

D

C B

A

System Components


Notes

Software


3 Software

Software


Software


• PEPconnect

• Atellica Solution PEP to Go Key Tasks for Basic Operation

Objectives Upon completion of this exercise you will be able to:

• Navigate the Command Bar, Workspace, and Status Bar

• Sign out and sign into the System

• Access PEPconnect

• Utilize Online Help

• View and acknowledge System Alerts

• Check System Health

Software


Navigate the Software

The software uses three areas of the screen to access system functions and information:

1. Command Bar • Allows the operator to perform and manage laboratory activities

2. Workspace

• Contains task buttons and displays sample and system information

3. Status Bar • Reports current system information and has selectable icons for quick access to system

functions

1

2

3

Software


Signing out of the System/Signing into the system To control the user security level, it is recommended that the operator signs out when walking away from the system, and then the next operator signs in with their credentials. Signing out and back in helps the software to run smoothly by refreshing all screens. Signing out of the System

1. On the Status bar, select the sign out icon 2. Select Sign Out 3. Select Yes

Signing into the System 1. At the sign in window, enter the operator ID and password 2. Select Sign In

Software


PEPconnect The e-learning experience, PEPconnect, enables the operator to access product-specific content for initial training and ongoing operations. Accessing PEPconnect in the Atellica Solution software:

1. On the Status bar, select the PEPconnect icon 2. PEPconnect will open in a separate window 3. To access the Atellica Solution content in PEPconnect, either

a. Enter search words in the Search Content and Groups field at the top of the screen

or

b. Navigate to Explore PEPconnect > Laboratory Diagnostics > Integrated Systems >

Atellica Solution

Software


Atellica Solution Online Help

The Online Help (OLH) icon on the status bar is accessible from every screen.

OLH provides links to help topics specific to the screen currently displayed and provides access to the table of contents where the entire Online Help package can be accessed.

The Search, Library, and Quicklinks functions provide the operator with quick access to information.

Software


System Alerts

The Alert Module displays all active module and system alerts. The color of the Alert Module designates the status of system alerts and defines them as system errors or warnings.

Each tab and subtab of the Command Bar that has an associated alert will display red or yellow until the alert is resolved.

A

B

C

D

A. Solid red tab - there are one or more unacknowledged errors

B. Black tab with a red outline - errors have been acknowledged but error condition(s) still exist

C. Solid yellow tab - there are one or more unacknowledged warnings

D. Black tab with a yellow outline - warnings have been acknowledged but warning condition(s) still exist

Software


Viewing and Acknowledging System Alerts The operator can view the Alert Module to display all active Module and system Alerts. To View and acknowledge system Alerts:

1. Above the Command bar, select the red or yellow tab

2. To Filter the alert list, select a Module or Category

3. To acknowledge individual alerts, select the hand symbol to the right of the alert

4. To acknowledge all alerts, select the Acknowledge Alerts button Note: Selecting Acknowledge Alerts does not resolve the system alerts. Action must be taken on the system

5. Suppresses all future notifications of this alert. Only suppress alerts that you do not want to be notified of again NOTE: Caution, if an alert is suppressed, the system will never notify you of this type of alert if the same situation recurs.

Software


Atellica Solution Checking System Health (Status)

To check the status of each module:

1. On the Command bar, select System

2. Select Status

3. Review the status for each module

a. Current State

b. Capabilities c. Alerts

Software


Hands-on Exercise: Explore the Software

Sign into the System (if needed)

Navigate to the Command Bar, Select the Samples Tab. (View page 59 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

1. Which 2 subtabs are available to view samples?

____________________________________________________________________

Navigate to the Command Bar, Select the Inventory Tab (View page 25 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

2. Which subtab would you select to view the supplies status?

_____________________________________________________________________

Select the identified subtab to view the supplies status

3. What is the status of IM Base (#11)?

_____________________________________________________________________

4. What is the status of the IM Cleaner (#9)?

_____________________________________________________________________

Checking your System Health (Status) 5. Identify the pictured module and list the status of each module on your system. (View page 10 in PEP to

Go Key Tasks for Basic Operation book if Atellica software is unavailable)

a. _____________________________________________

b. ____________________________________________

c. _____________________________________________

d. _____________________________________________

Software


Notes

Maintenance


4 Maintenance

Maintenance


Maintenance


• PEPconnect



• Utilize the Maintenance Schedule

Maintenance


At the Command Bar, select Maintenance > Schedule

Maintenance


Hands on Exercises: Maintenance At the Command Bar, select Maintenance > Schedule. (View page 16 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

1. How do you verify automated maintenance procedure passed?

______________________________________________________________________________

2. Circle the glyph below that indicates an Automated maintenance activity.

a. b. c. d.

Maintenance


Notes



5 Reagent and Supply Management





• PEPconnect



• Monitor the status of the supply and reagent inventories



Reagent Needs At the Command Bar, Select Inventory > Reagent Needs

The reasons for a posted need include the following:

Predictive: Suggested need based on the number of tests per day defined by the operator or system historic assay utilization*

Below Threshold: The reagent inventory level is below the operator defined alert threshold

Pending Orders: There are existing orders in the Worklist and no reagent is onboard for the assay

A need is red when the current inventory drops below a threshold defined by the operator on the Reagent Requirements Settings screen or when there are pending orders with no reagent available

*NOTE: The predictive forecast and alert threshold are both configured in the Reagent Requirements Settings screen.

*NOTE: The reagent needs for IM diluents and IM/CH wash fluids are posted based only on the Threshold criteria, not based on the prediction.



Reviewing the Reagent Overview Screen

At the Command Bar, select Inventory > Reagent Overview > IM



At the Command Bar, select Inventory > Reagent Overview > CH



IM Reagents

Example of an immunoassay primary and ancillary reagent

Chemistry Reagents

Example of a chemistry reagent with paired pack

Example of A1c_E reagent and Pretreatment



Supplies Overview

IM Supplies

At the Command Bar, select Inventory > Supplies Overview > IM

Scanning an IM System Fluid at the Module Display



CH Supplies

CH System Fluids

At the Command Bar, select Inventory > Supplies Overview > CH



Chemistry System Fluids

Chemistry System Fluid Drawer



Hands-on Exercise: Reagents and Supplies

At the Command Bar, Select Inventory > Reagent Needs. (View page 22 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

1. In the Reagent Needs, are there any reagents listed? _____________________________________________

2. Select one reagent, what is the Reason listed? _____________________________________________

3. How many packs do you need to load for that reagent? ______________________________________________

Supplies Overview

At the Command Bar, Select Inventory > Supplies Overview > IM. (View page 25 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

4. What is the OBS of the IM Cleaner number 9?

_______________________________________________

5. How many containers of IM Wash are on board?

______________________________________________



Notes

Monitoring Samples and Quality Control


6 Monitoring Samples and Quality Control





• PEPconnect



• Monitor sample status

• Determine the QC material needs



Monitoring Sample Status At the Command Bar, select Samples > Sample Handler

The Sample Handler tab provides an overview of the status of the SH, sample drawers, and all racks and sample containers in the sample drawers.

The system displays a colored glyph for each sample container position in every rack in the sample drawers and descriptive text beside each glyph.

Example:

A round glyph identifies a patient sample container

A square glyph identifies a calibrator or QC container



Quality Control: Determining QC Needs At the Command Bar, select Inventory > QC Needs

The QC Needs subtab is located under the Inventory command tab. A QC need is created for a QC material based on the following situations:

• The QC Scheduler is set up to create an order before the end of the current day. • A QC order was placed and QC material is not onboard.

NOTE: If the All checkbox at the bottom of the screen is not checked, only needs for which the QC material is not available will display. This is the default setting.



Monitoring QC Test Orders and Results At the Command Bar, select Worklist > Worklist Overview

The Worklist Overview screen can be used to view the status of test orders and results for calibration, QC, and patient orders. Once you have placed an order, navigate to Worklist > Worklist Overview to verify the sample has started processing.



At the Command Bar, select Worklist > Worklist Overview

To view results, select the checkbox associated with a result and select Edit/View and/or click on the test hyperlink. Click on glyphs associated with a result to get additional result information.



Hands-on Exercise: Monitoring Samples

At the Command Bar, select Samples and select the Sample Handler subtab. (View page 59 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

1. How do you determine when a sample has been aspirated?

________________________________________________________________________

Hands-on Exercise: Quality Control

At the Command Bar, select Inventory > QC Needs. (View page 48 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

2. Review the QC Needs workspace to answer the following questions:

a. Are there any QC materials listed that need to be loaded displayed in the screen? ___________________________________________________________________

b. What column is highlighted in RED? ___________________________________________________________________



Notes

Calibration


7 Calibration

Calibration


Calibration


• PEPconnect



• Describe how the system utilizes reagent lot and pack calibration intervals to determine calibration frequency

• Determine the calibration material that need to be loaded on the system

• Review calibration results

Calibration


Calibration Frequency Reagent calibration should be performed according to the following:

• Expired assay reagent calibration intervals • New assay reagent lot • Replacement of major system components or service • Troubleshooting quality control results • Government regulations • Laboratory quality control programs and procedures

The Atellica Solution manages reagent calibration by using both lot calibrations and pack calibrations. The Instructions For Use (IFU) contains the frequency requirements for lot and pack calibrations for each assay.

Calibration


Lot and Pack Calibration Intervals The system utilizes both reagent lot and reagent pack calibration intervals to determine when a reagent needs to be calibrated:

Lot Calibration Interval • Starts when a reagent pack with a new lot is calibrated within 24 hours after it is loaded on the system

for IM reagents, or 24 hours after the well is pierced for CH reagents

• The lot calibration will be valid for any pack with the same lot that is loaded on the system until the lot calibration interval expires

• A reagent pack that uses lot calibration to calculate results for the duration of the Pack calibration

interval or Lot expiration, whichever comes first

Pack Calibration Interval: • On the CH analyzer, a pack calibration is actually a well calibration. There are 2 wells in most CH packs,

which are treated as separate reagents by the system

• The pack/well calibration interval is valid for an individual pack for IM or well for CH, and not used for subsequent packs/wells placed on the system

• Useful for labs that perform a low volume of tests because they can avoid disposing of reagent packs

due to the QC shifts seen when calibrating aged packs

Example of a CH reagent Example of an IM Reagent

The system tracks lot and pack calibration and displays reminders when calibration or recalibration of an assay reagent pack is due.

NOTE: In order for a calibration to qualify as a lot calibration, the calibration must be done within 24 hours after a new IM pack is loaded on the system or 24 hours after a CH well is pierced. If a new pack/well is not calibrated within 24 hours, the calibration will be a pack calibration.

Calibration


Reviewing Calibration Needs The Calibration Needs provides a prediction of the calibrations that need to be performed by the end of the day* based on system settings.

A calibration need is created if one of following applies:

1. A pack or lot calibration will be ordered (based on the Test Definition settings) before the current day ends 2. There is a pending calibration order in the Worklist

A need will also be created if a lot calibration is required and no fresh packs are available. In this case, the Comment field will display “No valid pack onboard”.

On the Command Bar, select Inventory > Calibration Needs

Calibration expiration: Expiration date and time of the current calibration interval

• If the Calibration Expiration is RED, it indicates that the order will be generated within the threshold configured on the Alert Settings screen. The Reagent Overview screen, however, may display a green status for the well/pack in use at this time (Reagent Overview only shows the current status and is not a prediction).

Load the calibrator material on the system for any needs that are in RED and do not have usable calibrator material currently on board.

NOTE: The ‘end of day’ can be configured using the Day Setting on the Settings > System Configuration > Reagent Requirements Settings screen.

NOTE: If the All checkbox at the bottom of the screen is not checked, only needs for which the calibrator material is not available will display. This is the default setting.

Calibration


Review Calibration Results: Worklist Overview Screen

On the Command Bar, select Worklist > Worklist Overview

To view more details on results, navigate to the Calibration Results screen To view Calibration Results Details, select either the SID or Test Name for that order, OR select the order and then select the Edit/View button

Calibration


Calibration Results Screen- Details

QC Performed with Calibration – Provides a summary of QC results, when the system automatically performed QC with calibration

Acceptance Criteria – Displays the criteria used by the system to evaluate the calibration, and indicates whether each criteria failed or passed for the selected calibration

Comments – To enter a new comment, select the Edit button

Graph– Only displayed for CH. Graph of the results as Expected Concentration/System Response

Print

Calibration


Hands-on Exercises: Calibration

On the Command Bar, select Inventory > Calibration Needs. (View page 37 in PEP to Go Key Tasks for Basic Operation book if Atellica software is unavailable)

1. Are there any Calibrations displayed that need to be performed by the end of the day?

___________________________________________________________________________

View one calibration listed and answer the following questions.

2. What calibration material and/or reagent pack would need to be loaded to satisfy the need?

___________________________________________________________________________

Calibration


Notes

Troubleshooting


8 Troubleshooting

Troubleshooting


Troubleshooting


• PEPconnect



• Utilize the Operator Event Log

Troubleshooting


Troubleshooting

At the Command Bar, select System > Logs > Operator Event Log

Troubleshooting


Operator Event Log

• Displays system events as the events occur • Can be filtered based on time, module, error/warning • An event can be selected, the detailed information will display at the bottom of the workspace • Event Help enables you to review the event, possible causes, corrective actions, and corrective action

procedures • Comments can be added to an event

Corrective Actions

Events marked with the corrective action symbol must be resolved by the operator. After resolving, the event can be marked completed Unacknowledged Events

Events marked with the unacknowledged symbol can be acknowledged by the operator. To acknowledge an event: a. Select the event b. Either select the unacknowledged symbol for an event, or select Acknowledge All to acknowledge all

events

Troubleshooting


Hands-on Exercises: Troubleshooting

Review the Operator Event Log

1. How can you differentiate between an error and a warning?

________________________________________________________________________________________

Troubleshooting


Notes

Atellica® Solution Essentials

Documents

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