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