BD Kiestra ReadA User manual

Kiestra™ ReadA
User's Manual
L011043(04)2024-01
446948
English
bd.com/e-labeling

BD Kiestra™ ReadA User's Manual
Change History
Revision Date Change summary
02 2020-02
Minor typographical corrections. Updated
Australian and New Zealand Sponsors
Addresses. Updated Module Operating
Requirements. Removed paragraph about
preventive maintenance in the Cleaning and
maintenance section.
03 2022-03
Updated ISO symbols. Added CH REP symbol
with address. Added serious incident and safe
disposal statements. Added information about
the incubator rack tags. Updated references to
CDC manual and ISO 8573-1. Added Ordering
information topic.
04 2024-01
Updated cover page to new format, moved
addresses to and updated CH REP address in
the Contacts topic. Added U.S. patent statement.
Updated Symbols glossary and Glossary topics.
Updated images in the Components topic and
added a note to the Calibrating the
BDKiestra™Optis™ camera topic.
BD, the BD Logo, BD Kiestra Optis, Kiestra, and Synapsys are trademarks of Becton,
Dickinson and Company or its affiliates. All other trademarks are the property of their
respective owners. ©2024BD. All rights reserved.
For U.S. patents that may apply, see bd.com/patents.
No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval
systems, or translated into any language or computer language, in any form or by any means,
electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior
written permission of BD Kiestra, B.V., Marconilaan 6, 9207 JC Drachten, The Netherlands.
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Table of Contents
1 Instructions for use guidance 5
1.1 Customer release notes 5
1.2 Conventions 5
1.3 Notes, cautions, and warnings 6
1.4 Symbols glossary 6
1.5 Depiction of patient information 8
2 Introduction 9
2.1 Intended use 9
2.2 Module startup 9
2.3 Module description 9
2.3.1 BDKiestra™ ReadA incubator 9
2.3.1.1 Audible alerts and visual indicators 9
2.3.1.2 Components 10
2.3.2 Plate flow within theBDKiestra™ ReadA incubator 12
2.3.3 BDKiestra™ ReadA software application 13
2.3.3.1 General application layouts 14
2.3.3.2 Application toolbar 17
2.3.3.3 Application button bar 20
2.3.3.4 Machine tab 21
2.3.3.5 Logging tab 22
2.3.3.6 Debug Log tab 23
2.3.3.7 Sensor Charts tab 23
2.3.3.8 CSA tab 24
3 Configuration 25
4 Operation 27
4.1 Turning on module 28
4.2 Signing in and out 29
4.3 Startingoperation 30
4.4 Stopping operation 31
4.5 Turning off module 32
5 Cleaning and maintenance 33
5.1 Cleaning and disinfection 33
5.1.1 Frequency of routine cleaning 34
5.1.2 Cleaners and disinfectants 34
5.2 Cleaning methods 34
5.2.1 Dry cleaning 35
5.2.2 Wet cleaning/disinfecting 35
5.3 Cleaning strategies for incubator interior 35
5.3.1 Protocol A: Cleaning all racks with automated unloading 36
5.3.2 Protocol B: Cleaning all racks with manual unloading 37
5.3.3 Protocol C: Cleaning selected racks 38
5.4 Cleaning and maintaining BDKiestra™ ReadA components 40
5.4.1 Door seals 40
5.4.2 External Surfaces 40

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5.4.3 Humidification pan 41
5.4.3.1 Cleaning the humidification pan 41
5.4.3.2 Refilling the humidification pan 42
5.4.4 BDKiestra™ Optis™ camera 43
5.4.4.1 Cleaning the BDKiestra™ Optis™ camera 43
5.4.4.2 Calibrating the BDKiestra™ Optis™ camera 46
5.5 Incidental cleaning 53
5.6 Decontamination 54
6 Troubleshooting 57
6.1 Resolving errors 57
6.2 Creating an error report 59
6.3 Error messages 60
6.4 BDKiestra™ Optis™ error messages 68
7 Contacts 71
8 Limited warranty 73
9 Installation requirements 75
9.1 Module specifications 76
10 Cleaning table 79
11 Ordering information 81
12 Glossary 83
13 Index 87
BD Kiestra™ ReadA User's Manual

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1 Instructions for use guidance
Before using the product, it is recommended that all users become thoroughly familiar with the
contents of the instructions for use.
These instructions for use are a reference tool for trained laboratory personnel who operate
and maintain the product on a regular basis. Every attempt has been made to include all
information which would be required during normal use and maintenance.
These instructions for use describe the use of the BDKiestra™ ReadA connected to
BDKiestra™ Track. Customers with a BDKiestra™ ReadA™Compact in a Work Cell
Automation (WCA) or a Total Lab Automation (TLA) solution are referred to the instructions for
use that are provided with their solution.
EU Only: Users shall report any serious incident related to the device to the Manufacturer and
National Competent Authority.
OutsideEU: Contact your local BD representative for any incident or inquiry related to this
device.
Technical Service and Support: In the United States contact BD at 1.800.638.8663 or bd.com.
For regions outside of the United States, contact your local BD representative or bd.com.
Should a question arise that is not answered in these instructions, please contact BD.
See7Contacts.
1.1 Customer release notes
Customer release notes (in English) are available at bd.com/e-labeling.
1.2 Conventions
The following conventions are used in this guide:
Convention Example
Bold type is used for software options and to
indicate a menu path.
Select Save and select OK.
Select File > Save As.
Italics type is used for names of documents. For more information, refer to the Example
Instrument User's Manual.

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1.3 Notes, cautions, and warnings
Throughout the instructions for use, important information is presented in boxes offset from the
regular text that are labeled as a NOTE, CAUTION, or WARNING. These messages are
formatted as follows:
NOTE
Information worthy of special attention is presented as a NOTE.
CAUTION
Information on an activity which potentially could cause a product to malfunction
is presented as a CAUTION.
WARNING
INFORMATION ON AN ACTIVITY WHICH POTENTIALLY COULD CAUSE INJURY
TO THE USER IS PRESENTED AS A WARNING.
1.4 Symbols glossary
Some symbols listed below may not apply to this product.
US Customers only: For symbols glossary, refer to bd.com/symbols-glossary.
Symbol Meaning
CE marking; Signifies European technical conformity
In vitro diagnostic medical device
This only applies to US: “Caution: Federal Law restricts this device to
sale by or on the order of a licensed practitioner.”
Manufacturer
Authorized representative in the European Community
Authorised representative in Switzerland
Importer
Date of manufacture
Use-by date
BD Kiestra™ ReadA User's Manual

Symbol Meaning
Batch code
Catalogue number
Serial number
<Box #> / <Total Boxes>
OSHA NRTL safety approval, tested and certified to UL and CSA safety
standards by TÜV Rheinland®
OSHA NRTL safety approval, tested and certified to UL and CSA safety
standards by TÜV SÜD
Consult instructions for use or consult electronic instructions for use.
Alternating current
Biohazard
Caution
Collect separately.
Indicates separate collection for waste of electrical and electronic
equipment required.
Cut or sever hazard
Danger of crushing
Do not step
Do not use if package is damaged and consult instructions for use
Earth terminal to ground
Electrical shock
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1 - Instructions for use guidance

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Symbol Meaning
Frame/chassis
Hot surface
Class 2 laser
Low clearance
Moving parts - pinch point
On/Off
Pinch point
Refer to accompanying documentation
Sharp point
UV lamp
Indicates internal high voltage cables that remain powered after the
power switch is turned off
1.5 Depiction of patient information
Patient names, identification numbers, and medical information presented in the instructions
for use, including those within images of the graphical user interface (GUI), are provided as
examples only, and do not represent actual patients or clinical information.
BD Kiestra™ ReadA User's Manual

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2 Introduction
2.1 Intended use
The BDKiestra™ ReadA is an in-vitro diagnostic device system which consists of an incubator
and a camera module. The ReadA is used to incubate plates and to create images of plates.
Plates are automatically removed from the incubator, photographed, and returned to the
incubator or transported to another specified destination.
The BDKiestra™ ReadAis indicated for use in the clinical laboratory.
WARNING
WEAR PERSONAL PROTECTIVE EQUIPMENT (LAB COAT, GLOVES, SAFETY
GLASSES) WHEN INTERACTING WITH THE MODULE.
2.2 Module startup
The BDKiestra™Track module provides electrical power to the BDKiestra™ReadA module
and must be powered on before trying to startup ReadA. Refer to the BDKiestra™ Track
User's Manual for details on turning on Track.
When power is applied to the ReadA module, the following operations are performed:
lHardware is checked and initialized.
lVarious sensors and subsystems are verified.
The module reports any problems that require user attention through alerts. If anything arises
that would prevent proper operation, the startup process is canceled.
BD recommends that the module remain powered on at all times except during certain
maintenance procedures.
2.3 Module description
This section describes the ReadA components, general flow of plates in and out of the ReadA
module, and the ReadA software application.
2.3.1 BDKiestra™ ReadA incubator
Plates are stored in racks at predefined incubation conditions in the ReadA incubator.
The ReadA incubator should remain turned on at all times to ensure specimen integrity.
2.3.1.1 Audible alerts and visual indicators
Each ReadA contains an audible alert, which is used to inform the user if a warning or error
situation has occurred within the module.
The user can also refer to the ReadA application via the Track graphical user interface (GUI),
or the instrument status tile on one of the dashboards in the BDSynapsys™ Informatics
Solution, for visual status indicators. Refer to the BDSynapsys™ Informatics instructions for
use for more details regarding the dashboards and viewing an instrument status.

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See 6.1Resolving errors for more information on handling warning and error situations.
2.3.1.2 Components
Camera compartment
At predefined times, a plate is transported to the camera
compartment where photographs of the plate are taken
using a high-resolution camera and a variety of lightning
conditions. The images can be manually evaluated in the
BDSynapsys™ Informatics Solution, or can be used for
automated image evaluation using additional applications
provided by BD.
HEPA filter
Filters air around the camera
Humidification pan
Maintains adequate moisture levels for the plates in the
ReadA
Incubator
Incubates inoculated plates under controlled conditions.
The following notice on the incubator door indicates that
your ReadA has the CO2control option:
BD Kiestra™ ReadA User's Manual

Incubator racks
Incubator racks (1) house the plates inside of the incubator.
Rack positions are not interchangeable.
Rack identification tags (2) identify the rack positions inside
of the incubator.
The tag colors identify the general position of the racks:
lRacks with a blue tag are placed in the door of the
incubator.
lRacks with an orange tag are placed on the left side of
the incubator.
lRacks with a white tag are placed on the right side of the
incubator.
Rack tags provide the following information:
lD, L, R (3) are indicators for the Door, Left, or Right rack.
lThe number (4) next to the letter indicates the rack level
counted from the bottom of the incubator.
lThe numbers on the bottom of the tag (5) indicate the
rows included in the rack.
Contact BD to request incubator rack identification tags if
necessary.
Infeed and outfeed
Transfers plates into and out of the ReadA.
Manipulator
Transports plates to and from rack positions
Temperature / CO2controller
Used to set incubation conditions
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2 - Introduction

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2.3.2 Plate flow within theBDKiestra™ ReadA incubator
Plate storage
1. The plate is transported from the side lane of the Track (1) to the infeed of the ReadA (2).
2. ReadA scans the plate barcode to assign a storage location.
3. The manipulator (3) places the plate in a storage location (4).
Plate imaging
1. The manipulator (3) retrieves the plate.
2. The plate is transported to the camera infeed (5).
3. The plate barcode is scanned and the plate is transported to the image position (6).
4. An image of the plate is taken.
5. The plate is transported from the camera to the camera outfeed (7), and the barcode is
scanned. The manipulator places the plate into its designated storage location.
Transfer of a stored plate
1. The plate is retrieved by the manipulator and transported to the outfeed (8).
2. The outfeed transports the plate to the side lane of the Track (9).
3. Track transports the plate to the nearest Scanner to determine the destination.
BD Kiestra™ ReadA User's Manual

2.3.3 BDKiestra™ ReadA software application
The ReadA software application is accessed through the Track graphical user interface (GUI),
which is displayed on a touchscreen monitor mounted to the Main Base cabinet of
BDKiestra™ Track. The touchscreen monitor supports multitouch gestures and is operated
without the use of a keyboard or mouse.
lTo select or activate an element, tap the screen at the position of the element.
lValues may be entered using input fields, drop down fields, or value sliders.
lTo enter data into an input field, use the virtual keyboard in the Microsoft®Windows®
taskbar.
Figure 1 - Virtual keyboard in the taskbar
1. To open the virtual keyboard, select in the right corner of the Microsoft®Windows®
taskbar, located along the bottom of the screen.
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2 - Introduction

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2.3.3.1 General application layouts
BDKiestra™ Track GUI
The ReadA software application is accessed through the Track GUI.
Figure 2 - ReadA tab on Track GUI
1. Select ReadA to display a list of the ReadA modules attached to the Track.
2. Select a particular ReadA module to open the ReadA application within a remote
access window which overlays the Track GUI and allows the user to remotely control the
selected module.
BD Kiestra™ ReadA User's Manual

Remote access window
The ReadA application opens within a remote access window, which has its own toolbar.
Figure 3 - Remote Access window and toolbar
1. Select the in the tab at top-middle of the remote access window to close it and return to
the Track GUI.
2. Select to drag the ReadA application around to make certain parts more visible.
3. Select to identify which mouse click (left, center, right) to emulate when touching the
screen.
4. Select to access detailed settings.
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2 - Introduction

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ReadA application main window
The ReadA application is divided into six main areas: the title bar, toolbar, button bar, tab
menu, tab content area, and the general module status area. If a user level is not configured to
have access to a particular item, it will not be visible.
Figure 4 - ReadA main window
1. The title bar (1) shows the name and version of the application, and provides the ability to
minimize, maximize, or close the application.
2. The toolbar (2) provides access to a number of tools and commands.
3. The button bar (3) provides quick access to commonly used options.
4. The tab menu (4) provides access to functionality needed to run the ReadA module.
5. The tab content area (5) contains information for the tab selected.
6. Error and warning messages are shown at the bottom of the screen (6) and describe where
the error or warning has occurred, and a hint on how to resolve it.
BD Kiestra™ ReadA User's Manual

7. The right side of the tab content area (7) displays general module status, and is always
displayed regardless of which tab is selected:
lMachine state (8): E.g., Production, Stopped, Initializing
lMachine status (9): Shows the PLC activity, the production start time, length of the
current production run, and communication with other devices
lProduction counters (10): Shows incubator capacity and the number of plates
processed at the various transit points
lBarcode Scanners (11): Displays the most recently scanned barcodes at the various
transfer points
lImage (12): Displays the most recent plate image
2.3.3.2 Application toolbar
A toolbar option can only be selected when a user is logged in and the option is enabled (i.e.,
text is clearly visible and icon is colored).
Figure 5 - Toolbar options
1. Select Log on to log in to the application. If it appears disabled (text and icon are grayed
out), that means you are already logged in. See 4.2Signing in and out.
2. Select Log Off to log out of the application. If it appears disabled (text and icon are grayed
out), that means you are not logged in, and therefore cannot log out. See 4.2Signing in
and out.
3. Select Process Vision [F12] to get an overview of current processes. Additional
operations are available for advanced users in this view.
4. Select Tools [F7] to expand the Tools menu. In some cases, the module needs to be
stopped or started for the option to become available.
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Tools menu options
Option Description
Deregister
container from
machine
ReadA must be stopped in order to deregister a single plate from the
database. When you deregister a plate, the incubation time is
interrupted.
Upon selection, the following pop-up window appears:
1. Enter the barcode and select Search container. The plate data
appears in the lower part of the dialog.
2. Select Remove container to deregister the plate.
3. Manually remove the plate from the incubator.
Deregister all
containers (empty
ReadA)
ReadA must be stopped in order to deregister all plates currently in the
incubator. Use this option to manually empty the ReadA when
maintenance or cleaning is required.
Upon selection, a pop-up dialog appears asking “Are you sure to
deregister all containers?”.
1. Select OK to confirm, or select Cancel.
2. If you select OK, all plates will be deregistered.
3. Manually remove all plates from the incubator.
Reset disk space
warning & error
Modify at what point a warning and/or an error must be generated if
available disk space (used for storage of images) approaches a critical
level.
Force empty
reserved racks
ReadA must be started in order to automatically empty the reserved
racks. The plates are transported to other, non-reserved, rack locations.
If no rack locations are available, the plates are transported to the Track
error Stacker.
BD Kiestra™ ReadA User's Manual

Option Description
Force empty
container store
(cleaning)
Automatically empty the ReadA if maintenance or cleaning is required.
The plates are transported via the outfeed to the Stackers. Input from
Track is blocked.
Upon selection, a pop-up dialog appears.
1. Select OK to confirm, or select Cancel.
Disable ProceedA
input Block input from Track.
Disable ProceedA
communication Disable communication with Track.
Rack reservation
& removal
ReadA must be stopped in order to view and modify which racks have
been reserved and/or removed. Upon selection, the Remove/Reserve
racks dialog appears:
The racks are represented in blocks.
1. Right-click a rack to toggle the status to:
lgreen: available
lyellow: reserved
lgray: removed
2. After the rack status has been changed, select Apply changes to
save, or select Undo changes to cancel.
A rack status can only be changed to Removed if the rack is empty. A
rack status can be changed to Reserved and yet still contain a plate.
When the plate is later moved from its rack position and returned to the
incubator, the ReadA will not be able to find the plate position in the
reserved rack.
Optis™
calibration tool
ReadA must be stopped in order to calibrate the BDKiestra™Optis™
camera. See 5.4.4.2Calibrating the BDKiestra™ Optis™ camera.
Single manual
infeed
ReadA must be started in order to manually enter one plate into the
ReadA infeed. This option should only be used by advanced users.
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2 - Introduction

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2.3.3.3 Application button bar
A button can only be selected when a user is logged in and the button is enabled (i.e., text is
clearly visible and icon is colored).
Figure 6 - Button bar options
1. Select Start [F2] to start operation of the ReadA. See 4.3Startingoperation for more
information on when you might use it.
2. Select Stop [F4] to stop the ReadA. This will not stop the incubator or the PC. The camera
compartment will be emptied and all plates moved into the incubator. See 4.4Stopping
operation for more information on when you might use this option.
3. Select Reset error [F5] to reset the error if an error has occurred and has been resolved.
An Error log dialog will appear. See 6.1Resolving errors
4. Select Beeper off [F6] if an error occurs and an audible alarm is activated. While resolving
the error, select the button to turn off the alarm. See 6.1Resolving errors
5. Select Unlock door [F8] to unlock the incubator door and the cover over the camera unit.
Select the button again to lock the door and the cover.
6. Select Init machine if the ReadA does not start up after selecting Start [F2] and no error is
indicated. A pop-up dialog appears, asking if you really want to do this. Select OK to
confirm, or select Cancel.
BD Kiestra™ ReadA User's Manual