Siemens Healthineers Atellica VTLi User manual

User Guide

No part of this user guide or the products it describes may be reproduced by any means or
in any form without prior consent in writing from Siemens Healthcare Diagnostics.
The information in this user guide was correct at the time of printing. However,
Siemens Healthcare Diagnostics continues to improve products and reserves the right to
change specications, equipment, and maintenance procedures at any time without notice.
If the system is used in a manner differently than specied by
Siemens Healthcare Diagnostics, the protection provided by the equipment may be
impaired. See warning and hazard statements.
© 2021 Siemens Healthcare Diagnostics. All rights reserved.
Atellica is a registered trademark of Siemens Healthcare Diagnostics.
All other trademarks are the property of their respective owners.
11538071 Rev. C, 2021-12
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Phone: [phone]
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11556029

User Guide
Atellica® VTLi Immunoassay Analyzer

Contents
Chapter 1 Exploring the Analyzer
About this User Guide 2
Intended use 2
Summary and Explanation 2
General warnings and precautions 2
Cleaning the analyzer 2
Getting to know the Atellica VTLi system 3
VTLi Immunoassay analyzer 3
Docking station 3
Service software 4
Test cartridges 4
Setting up the Atellica VTLi Analyzer 4
Materials Provided 4
Special Materials Required (Not Provided) 4
What’s in the Box? 4
Unpacking and assembly 4
Identifying the analyzer controls 6
Identifying the docking station controls 7
Connecting the docking station 8
Installing the analyzer battery 8
Conguring the analyzer 9
Turning the analyzer On/O 9
Working with the docking station 9
Exploring the user interface 10
The Home screen 10
Common icons and buttons 11
Entering information 12
Operating the barcode reader 12
Using the on-screen keyboard 13
Logging on and o 13
Learning more about the Atellica VLTi Analyzer 14
Instructions for use 14
Advanced User Guide 14
Quick Start Guide 14
Safety Information 14
Protecting Yourself from Biohazards 14
Recognizing Sources of Contamination 14
Preventing Contamination 14
References 15
Chapter 2 Running a Test
General Warnings and precautions 18
Preparing for testing 18
Working with reagent cartridges 18
Collecting a sample 19
Performing a test 19
Testing warnings and precautions 19
Basic test workow 20
Identifying the patient 20
Inserting a cartridge 20
Selecting the sample type 21
Adding the patient sample 21
Viewing results and result details 22
Removing a cartridge 22
Finishing a test 23
Performing successive tests 23
Working with Patient Test Results 23
Viewing patient test results 23
Filtering test results 24
Chapter 3 Performing Quality Control
About Quality Control 26
Guidelines when running a QC test 26
Performing a Quality Control (QC) test 26
Working with QC Test Results 28
Viewing QC test results 28
Filtering test results 28
Adding new QC lots 29
Analyzer messages and troubleshooting 32
Chapter 4 Maintenance
General Troubleshooting 32
Maintenance 33
General warnings and cautions 33
Cleaning and disinfection 33
Cleaning the Atellica VLTi Analyzer 33
Disinfecting the Atellica VLTi Analyzer 36
Battery care 36
Displaying analyzer information 38
Viewing Connectivity settings 38
Orderable Supplies 39
Appendix A Specications
Technical Specications 42
Electromagnetic Compatibility (EMC) 43
Declaration of compliance 43
IT Security 43
Disposal of the Analyzer 43
Technical Assistance 44
Training 44
Appendix B Symbols
Symbols 46
Glossary 47
Abbreviations 48
Appendx A Theory of Operatoins
Overview 50
Index 53

CHAPTER 1
Exploring the Atellica
VTLi Immunoassay
Analyzer

2
About this User Guide
This user guide describes the Atellica® VTLi Immunoassay analyzer features and explains
how to operate and maintain it. You should carefully read this user guide before using the
device and its consumables. Make sure to keep this user guide for future reference.
The following conventions are used throughout this guide:
Symbols Description
Indicates additional information about a feature or screen.
Indicates important operations or safety information.
Indicates a potential biohazard danger. Always follow standard safety practices
and your local laboratory guidelines when working with biohazard materials.
Next > Finish In instructions, indicates a series of commands you tap to reach a screen.
Intended use
The Atellica® VTLi Immunoassay Analyzer is intended to be used by healthcare professionals
in clinical laboratories and point-of-care settings, to measure the concentration of bio-
markers in whole blood or plasma using disposable cartridges.
The Atellica VTLi Immunoassay Analyzer is a solution for the quantitative evaluation of
immunoassays using Magnotech® technology.
General warnings and precautions
Always observe these safety and usage guidelines when testing patient samples using the
analyzer.
‒Always follow your facilities established safety guidelines and standard procedures.
‒Wear personal protective equipment such as safety glasses, gloves, lab coats, or aprons
when working with possible biohazard contaminants.
‒Dispose of contaminated materials according to your laboratory’s biohazard control
procedures.
‒Do not use the analyzer in the proximity of a strong magnetic eld.
‒This device contains sensitive components. Handle with care, prevent shocks and
sudden changes in temperature and humidity.
For more information, see Safety Information, on page 14.
Cleaning the analyzer
You should clean the analyzer using the Siemens Healthineers recommended cleaning
guidelines.
For more information, see Cleaning and disinfection, on page 33.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

3
Getting to know the Atellica VTLi system
The Atellica VTLI system consists of the following components:
‒Analyzer
‒Docking station
‒Service software
‒Test cartridges
VTLi Immunoassay analyzer
The analyzer is a handheld point of care device that performs a test on a sample.
After inserting a new, unused cartridge into the analyzer, the analyzer instructs the user to
apply the sample at the appropriate time. The analyzer then performs the test and displays
the test results. The analyzer will not perform a test if a sample is applied to the cartridge
before the cartridge is inserted into the analyzer. The analyzer also provides 2.4GHz Wi
functionality for data transfer.
A best practice is to ensure at least 1 LAN connection is available in case of Wi
network issues.
Docking station
The analyzer can be docked in the docking station to:
‒Perform a test
‒Charge the battery
‒Congure the analyzer via the service software
‒Upload data or test results (via middleware software) to hospital information systems if
applicable.
One docking station can support multiple analyzers.
Service software
The service software allows you to do the following:
‒Congure the analyzer
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

4
‒Monitor the analyzer status
For more information, see the Atellica VTLI Immunoassay Analyzer Advanced
User Guide.
Test cartridges
The analyzer used disposable cartridges to test patient samples. Each cartridge is for
single use only; never perform a test with a previously used cartridge. For each test, refer
to the instructions for use supplied with the cartridges. The sample material depends on
the test that has to be performed. The sample can be whole blood or plasma. Consult the
instructions for use of the test for the denition of the sample.
Setting up the Atellica VTLi Immunoassay Analyzer
Materials Provided
Atellica VTLi Immunoassay Analyzer
Special Materials Required (Not Provided)
‒Quality Control Materials
What’s in the Box?
Your Atellica VTLi system is contained in a single box, containing:
‒Analyzer
‒Docking station
‒Power cords, AC power supply, Ethernet cable, battery, torx screwdriver
‒Documentation pack (Users Guide, Quick Reference Guide)
You must order the test cartridges separately.
Installation guidelines
‒The docking station requires a power connection.
‒The docking station provides a connection to the local network or directly to a
computer.
‒A computer is required to install the Service software, which manages the
communication to and from the installed analyzer(s) for conguration and service
purposes, and middleware software, which manages data transfer to the hospital
information system.
‒Siemens Healthineers recommends using Windows NTP to implement the CT prole.
The service PC should have this solution installed/enabled.
‒VPN connections are advised for remote service for Siemens Healthineers remote
Service (and middleware software remote service).
Contact your local Siemens Healthineers representative if connection to a laboratory
information system is needed.
The electromagnetic environment should be evaluated prior to operation of the
device. Do not use this device in close proximity to sources of strong electromagnetic
radiation (e.g., unshielded intentional RF sources), as these can interfere with the
proper operation. This equipment complies with the emission and immunity
requirements of the IEC 61326 series.
Unpacking and assembly
Follow these instructions to unpack and assemble the Atellica VTLi Immunoassay Analyzer.
Inspect the box and contents and notify your delivery representative if you notice any
damage or missing items.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

5
INSTRUCTIONS
1. Carefully open the shipping box and remove the documentation pack from the top foam
insert.
1
2
3
1User documentation (User Guide, Quick Reference Guide)
2Analyzer, Docking Station Power supply, battery, power
cords, torx screwdriver
3Inner box with: Power supply, battery, power cords, torx
screwdriver
2. Carefully open the inner box.
3. Remove the 2 plastic pouches from the foam insert. One contains the analyzer and the
other the docking station.
4. Remove the empty analyzer/docking station foam insert.
5. Remove the accessory items from the accessories foam insert.
6. To remove the analyzer and docking station, carefully open each pouch.
7. To remove the user documentation, open the documentation pack and remove the
contents.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

6
Identifying the analyzer controls
Side view
1 2 34
1Barcode scanner
2Battery cover
3On/Off button
4Reset button
Top view
1
2 3 4
1Cartridge insertion area
2Cartridge slot
3Analyzer cover
4Analyzer screen
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

7
Identifying the docking station controls
Back view (connection ports)
1 2 3
1Not used
2Network connection
3Power supply adapter connection
Top view
1 2
1Analyzer connection socket
2Cooling fan
Don’t insert objects or spill uids into the cooling fan area to avoid malfunction of the
cooling system.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

8
Connecting the docking station
INSTRUCTIONS
1. Connect one end of the Ethernet cable to the docking station, and the other end either
to a port on the local network or directly to the PC.
2. Connect the AC power adapter to the docking station and connect the AC power adapter
to the power source using the power cord.
The docking station should be connected to the AC power source so that it can charge
the analyzer battery and cool the analyzer with the cooling fan. If the docking station is
not connected to the power supply with the analyzer docked, the analyzer battery
will drain.
Installing the analyzer battery
Before you can use the analyzer, you need to install the battery using the torx screwdriver
included in the accessories box.
Prior to use, you must charge the analyzer battery for at least one hour to ensure that
the analyzer can function correctly when it is used undocked. A partial battery charge
takes one hour; a full battery charge takes approximately 2 hours.
When undocked, the system is capable of performing at least one test after one hour
of battery charging, but it is preferable to fully charge the battery before using for the
rst time
INSTRUCTIONS
1. On the back of the analyzer, locate the small screw holding the battery cover in place.
2. Use the torx screwdriver to remove the screw completely and set it aside.
3. Slide the cover upward to remove it from the analyzer.
4. Insert the battery plastic wire connector into the analyzer. You should hear or feel it
snap into place.
5. Fit the new battery into the battery compartment.
6. Position the wires before reattaching the cover.
Ensure that the wires are not crimped and will not interfere with reattaching the
battery cover.
7. Slide the battery cover back into place on the analyzer.
8. Reinsert and gently tighten the battery cover screw.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

9
Conguring the analyzer
The nal step in setting up the analyzer is to use the Service software to congure analyzer
connectivity, users, and tests and workow options.
Refer to the Atellica VTLi Immunoassay Analyzer Advanced User Guide for complete
instructions on installing and using the Service software.
Follow your hospital or laboratory procedures to ensure proper installation.
Turning the analyzer On/Off
Powering On the analyzer
INSTRUCTIONS
1. Press the Power button located on the side of the analyzer.
2. The analyzer starts and performs a self test to ensure correct operation. Progress of the
self test is displayed on the analyzer screen.
3. Wait for the analyzer to nish the self test before continuing to operate it. The Home
screen displays when the self test is nished.
The analyzer Self test is performed dependent on “time passed since last performed self
test” and dependent on “number of tests done since last performed self test.
Powering Off the analyzer
1. Do one of the following:
‒To shut down the analyzer, press and hold the Power button for several seconds.
‒To put the analyzer into standby mode, briey press the Power button.
The analyzer cannot be shut down when a test is in progress. After the patient has
been identied, a test is considered in progress from the time the cartridge insertion
screen is shown until the test result has been accepted or rejected.
Working with the docking station
Docking the analyzer
Docking allows the analyzer to charge and cool down.
INSTRUCTIONS
1. Place the analyzer in the docking station so that the docking station connectors are
engaged.
2. Gently push the analyzer to connect the analyzer to the docking station.
Undocking the analyzer
INSTRUCTIONS
1. Lift the analyzer out of the docking station.
2. If necessary, the analyzer automatically performs a self test, depending on the
frequency congured when the analyzer is undocked.
When the analyzer is undocked, it:
‒Runs on battery power alone
‒Is not cooled down by the docking station
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

10
Docking station status indicators
The indicators on the docking station a visual operational status.
Status Indicators
The analyzer is docked correctly.
The analyzer is not docked or not docked correctly.
Try docking the analyzer again. Press the analyzer gently after docking to help
secure the connection.
Solid = Error
Exploring the user interface
The touchscreen user interface allows you to interact with the analyzer to perform testing,
quality control, and other tasks. It also displays messages, status information, and other
details about the analyzer or task.
The Home screen
1
2
3
Scan
patient ID
Log Off
12:23AM 05/25/2019
M!
Patient Test
hs cTnI 2
hs cTnI 1
hs cTnI 3
1Status bar - contains indicators for time, date, memory usage, connectivity status,
and battery level.
Tap the status bar to display the System Status screen. Tap to return to the
Home screen.
2Navigation bar - contains the main menu button and screen title (for example,
Patient Test).
3Main display - provides information about analyzer status and next steps, provides
guiding illustrations, displays system messages, shows results, and serves as a
location for data input, when applicable.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

11
Test result screen
1Sample identication bar - contains patient information for a patient test or
information about the quality control (QC) for a QC test
2Test information bar - displays the:
‒test name and version
‒test end time (if applicable)
‒repeat indicator
‒cartridge symbol
‒test sequence number
If the test is a repeat test, the repeat icon appears next to the test number.
Common icons and buttons
Icons and Buttons
Display main menu Display on-screen keyboard
Go back Scan a barcode
Battery is fully charged
The battery is almost empty. Dock
the analyzer to recharge the battery.
An undocked test is still possible,
but recharging the battery is
strongly advised.
Battery is charged (75%) Battery is empty. A test can only be
performed on the docking station.
Battery is charged (50%)
Shows when the battery is charging.
The current battery level is also
indicted during charging.
Memory Low. The analyzer has reached
the low storage limit. Only a limited
number of tests can be performed with
the available memory.
Analyzer memory is full. No more
tests can be stored.
Free up memory by uploading
results or contact your local
administrator for assistance.
1
2
1
01
12:45 PM
Patient Test Result
HScTnl
M!
12:23AM 05/25/2019
123456789
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

12
Icons and Buttons
The analyzer is connected to the LAN
network, but there is currently no data
transfer.
The analyzer is connected to the wireless
network, but there is currently no data
transfer.
Quality control lot status indicator.
All lots are up-to-date.
The analyzer is connected to the network,
and there is active data transfer.
Quality control lot status indicator.
A lot is about to expire.
The analyzer is not able to establish a
network connection.
Quality control lot status indicator.
A lot has expired.
Move down or up in a list or page POS
NEG
Positive or Negative qualitative
result indicator
Move left or right in a list or page Result blinding indicator
Indicates a patient test. Pass
Fail Pass or Fail QC test result indicator
Indicates a QC test.
Entering information
You can enter information, such as a Patient ID, on the analyzer in 2 ways:
‒Barcode reader
‒Touch screen keyboard
When the analyzer requires information, such as a Patient ID (PID), it prompts you to use
the barcode reader. The barcode reader enables you to easily scan important information
directly into the analyzer.
Operating the barcode reader
INSTRUCTIONS
1. Aim the barcode reader at the item you want to scan.
The red and green lights help you to aim the scanner on the barcode. Center the aiming
beam over the barcode.
2. Tap to activate the scanner.
The screen changes when the barcode is accepted.
Tips for scanning
‒Hold the item in the center of the scan window, not too close or too far away
‒For items with more than one barcode, make sure you scan the intended barcode.
‒Ensure proper lighting.
‒If the code being scanned is on a highly reective surface (for example, a laminated
surface), tilt the barcode slightly to reduce reection.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

13
Using the on-screen keyboard
The on-screen keyboard is another way you can enter information.
INSTRUCTIONS
1. Tap .
2. Do one of the following:
‒To enter uppercase letters, tap a..z and then tap the key that corresponds to the letter
you want.
‒To enter a space, tap .
‒To enter numbers, tap 0..9 and then tap the key that corresponds to the number you
want.
‒To enter special characters, tap !@#and then tap the key that corresponds to the
character you want.
‒To delete the previous character you entered, tap C.
‒To enter lowercase letters, tap and then tap the key that corresponds to the letter
you want.
When entering sensitive data, such as a password, the selected character appears
briey in the entry eld and is then hidden by a concealing character.
Logging on and off
You can enter your User ID on the analyzer using the barcode scanner.
INSTRUCTIONS
1. Aim the analyzer barcode sensor at the User ID you want to scan.
2. On the User Login screen, tap Scan User ID.
You can also tap Keyboard to enter your User ID using the on-screen keyboard.
If the ID not found message displays, tap Try again to rescan. Or tap to enter
using the on-screen keyboard.
Your user information displays if the login is successful.
Logging off the analyzer
1. In the dashboard, tap Log out.
The Logout user prompt displays.
2. Tap Yes.
The User Login screen appears.
_
ABC
JKL
TUV
!@#
GHI
PQRS
C
DEF
LMO
WXYZ
a...z
_
C
A...Z
_
2
5
8
0
4
7
3
6
9
1
_
C
A...Z
_
-
@
/
!
,
_
#
‘
.
a...z
a..z
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer

14
Learning more about the Atellica VLTi Immunoassy Analyzer
Refer to the following for additional information about Atellica VLTi Immunoassay Analyzer.
Instructions for use
Read the instructions for use (IFU) that shipped with your test cartridge and quality controls. The
IFU contains important information about your kits and their contents. Keep the IFU for future
reference.
Advanced User Guide
Refer to the Atellica VLTi Immunoassay Analyzer Advanced User Guide for additional conguration
settings. The guide is located on the Siemens Healthineers Document Library at:
https://doclib.siemens-healthineers.com/home
Quick Start Guide
Graphical reference guide provides quick details on performing patient and quality control tests.
Safety Information
Read the following safety information to protect yourself in the hospital or laboratory.
Protecting Yourself from Biohazards
The established guidelines for handling laboratory biohazards are based on the guidelines
developed by the Centers for Disease Control, the Clinical and Laboratory Standards Institute, and
the Occupational Safety and Health Administration.
Use these safety guidelines for general information only. It is not intended to replace or supplement
your laboratory or hospital biohazard control procedures.
By denition, a biohazardous condition is a situation involving infectious agents biological in nature,
such as the hepatitis B virus, the human immunodeciency virus, and the tuberculosis bacterium.
These infectious agents may be present in human blood, blood products, and other body uids.
Recognizing Sources of Contamination
When you handle potentially infectious agents, keep in mind the following major sources of
contamination:
‒Hand-to-mouth contact
‒Hand-to-eye contact
‒Direct contact with supercial cuts, open wounds, and other skin conditions that might permit
absorption into subcutaneous skin layers
‒Splashes contact with skin and eyes
Preventing Contamination
To prevent accidental contamination in a clinical laboratory, strictly adhere to the following
procedures:
‒Wear gloves while servicing parts of the analyzer that have contact with body uids.
‒Wear facial protection when splatter or aerosol formation is possible.
‒Wear personal protective equipment such as safety glasses, gloves, lab coat, or apron when
working with possible biohazard contaminants.
‒Dispose of contaminated materials according to your laboratory’s biohazard control procedures.
Chapter 1 - Exploring the Atellica VTLi Immunoassay Analyzer