BD Kiestra InoqulA User manual

Kiestra™ InoqulA
User's Manual
BD Kiestra B.V.
Marconilaan 6
9207 JC Drachten, The Netherlands
BD Switzerland Sàrl
Terre Bonne Park – A4
Route de Crassier 17
1262 Eysins, Switzerland
Australian and New Zealand Sponsors:
Becton Dickinson Pty Ltd.
66 Waterloo Road
Macquarie Park NSW 2113, Australia
Becton Dickinson Limited
14B George Bourke Drive
Mt. Wellington Auckland 1060, New Zealand
L012127(09) 2022-06
446958, 446971, 446972, 446973
English
bd.com/e-labeling

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Change History
Revision Date Change Summary
07 2021-02 Added information for additional specimen
containers, broth tubes, and SA slide heater.
08 2021-09
Added Slide Processing Module feature updates.
Updated instructions for loading broth tube
racks. Updated bead dispenser cleaning. Added
bead dispenser troubleshooting instructions.
Added error messages. Added descriptions of
secondary spreading patterns.
09 2022-06
Updated Serious Incident Statement. Updated
screen shots for integrated InoqulA. Added
InoqulA user configuration options. Added
specimen containers. Added detail for use of
SAslide dispenser. Added detail for SPM ink
cartridge maintenance.
BD, the BD Logo, BBL, ESwab, Kiestra, MAX, Phoenix, Synapsys, and Vacutainer are
trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the
property of their respective owners. ©2022BD. All rights reserved.
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.
BD Kiestra™ InoqulA User's Manual

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Table of Contents
1 Instructions for use guidance 7
1.1 Customer release notes 7
1.2 Conventions 7
1.3 Notes, cautions, and warnings 7
1.4 Symbols glossary 8
1.5 Depiction of patient information 9
2 Introduction 11
2.1 Intended use 11
2.2 Module description 11
2.2.1 Deck layout and plate path 12
2.2.2 User interface 13
2.2.2.1 BarcodA user interface 14
2.2.2.2 InoqulA user interface 17
3 Configuration 23
3.1 BarcodA configuration 23
3.1.1 Configuring destackers 24
3.1.2 Configuring stackers 25
3.2 InoqulA configuration 26
3.2.1 Configuring specimen tubes 28
3.2.2 Desktop printer settings 28
3.2.2.1 Setting print darkness 29
3.2.2.2 Setting print speed 29
3.2.2.3 Setting the label left offset 29
3.2.2.4 Setting the label top offset 30
3.2.3 Validation settings 30
3.2.3.1 Aspirate volume validation 31
3.2.3.2 Broth volume dispense validation 31
3.2.3.3 Plate dispense volume validation 32
3.2.3.4 Slide dispense volume validation 32
3.2.4 SPM settings 33
3.2.4.1 Setting the slide drying time 33
3.2.4.2 Using slide drying time for validated volumes 33
3.2.4.3 Stop processing for SPM high temperature 34
3.2.4.4 Stop processing when SPM is out of slides 34
3.2.4.5 Setting the slide dispense bottom offset 35
3.2.4.6 Setting the slide re-aspiration bottom offset 35
3.3 Language settings 35
3.4 Setting inactivity logout time 36
3.5 Setting the clock display mode 36
3.6 Scheduling database backup 37
3.7 Enabling warning alarms 37
3.8 Setting warning alarm duration 38
3.9 Enabling error alarms 38
3.10 Setting error alarm duration 38
3.11 Configuring barcode scanners 38

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4 Operation 41
4.1 Startup 41
4.2 Login 43
4.3 Starting normal operation 43
4.4 Responding to notifications 44
4.5 Pausing operation 45
4.6 Emergency stop 45
4.7 Managing consumables 45
4.7.1 Selecting a media template 46
4.7.2 Filling destackers with plates 46
4.7.3 Loading pipette tips 46
4.7.4 Beads 47
4.7.5 Loading the SPM slide rack 48
4.7.6 Loading the SA slide dispenser 49
4.8 Fully automated specimen processing 49
4.8.1 Printing broth tube labels 50
4.8.2 Placing broth tubes in racks 51
4.8.3 Loading broth tube racks 51
4.8.4 Relabeling broth tubes 52
4.8.5 Placing specimen containers in racks 52
4.8.6 Loading specimen container racks 55
4.8.7 Starting fully automated processing 55
4.8.8 Processing Stat racks 56
4.8.9 Processing Stat slides 56
4.8.10 Unloading stackers 57
4.8.11 Unloading specimen container racks 57
4.8.12 Unloading the SPM slide rack 57
4.9 Semi-automated specimen processing 58
4.9.1 Defining a specimen batch 58
4.9.1.1 Deleting a specimen during batch creation 60
4.9.1.2 Adding or deleting a media protocol during batch creation 60
4.9.2 Starting semi-automated processing 61
4.9.2.1 Rejecting a plate during inoculation 63
4.9.2.2 Reprinting labels 64
4.10 End of run cleanup 64
4.11 Shutdown 65
5 Routine cleaning and maintenance 67
5.1 Cleaning and disinfection 67
5.2 Frequency of routine cleaning 68
5.3 Cleaners and disinfectants 68
5.4 Cleaning methods 68
5.4.1 Dry cleaning 69
5.4.2 Wet cleaning 69
5.5 Cleaning components 69
5.6 Cleaning table 73
5.7 Incidental cleaning 74
5.8 Decontamination 75
5.9 Preventive maintenance 76
5.10 Replacing the BarcodA printer ribbon and labels 76
5.11 BarcodA printer alignment 80
5.12 Replacing the InoqulA printer ribbon and labels 81
5.13 Purging the SPM print head 82
5.14 Replacing the Slide Processing Module ink cartridge 83
5.15 Cleaning the Slide Processing Module ink cartridge head 83
BD Kiestra™ InoqulA User's Manual

6 Troubleshooting 87
6.1 Responding to errors 87
6.2 Stacker errors 88
6.3 Bead dispenser errors 88
6.4 BarcodA error messages 89
6.5 InoqulA error messages 90
7 Supporting applications 99
7.1 Specimen Creator 99
7.2 Spreading patterns 100
7.2.1 Description of spreading patterns 100
7.2.2 Selecting a pattern based on specimen type 100
7.2.3 Specimen application methods 101
7.2.4 Primary patterns 102
7.2.4.1 Zigzag pattern 4 102
7.2.4.2 Zigzag pattern 6 103
7.2.4.3 Quadrant pattern 18 104
7.2.4.4 Quadrant pattern 19 104
7.2.4.5 Quadrant pattern 20 105
7.2.5 Secondary patterns 106
7.2.5.1 Pattern 1: Lawn pattern 106
7.2.5.2 Pattern 5: zigzag 3,5 - 1 InocStreak s200 107
7.2.5.3 Pattern 7: zigzag 3,5 - s200 107
7.2.5.4 Pattern 8: 3,5 - 1 s200 more growth 108
7.2.5.5 Pattern 13: Defect media pattern 109
7.2.5.6 Pattern 2: 4-Quadrant uniform s200 110
7.2.5.7 Pattern 3: 4-Quadrant s200 111
7.2.5.8 Pattern 9: zigzag 3,5 - 1 s200 more growth 111
7.2.5.9 Pattern 10: zigzag 5 mm + 2,5 - 1 s200 112
7.2.5.10 Pattern 11: zigzag 2,5 mm - 1 inoc s200 113
7.2.6 References 113
8 Contacts 115
9 Limited warranty 117
10 Installation requirements 119
10.1 Module specifications 119
10.2 Accessories specifications 121
11 Ordering information 123
12 Glossary 127
13 Index 131
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Table of Contents

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BD Kiestra™ InoqulA 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.
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.
Refer to the Eudamed website: https://ec.europa.eu/tools/eudamed for Summary of Safety
and Performance.
Should a question arise that is not answered in these instructions, please contact BD.
See8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.
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.

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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
Catalogue Number
Consult instructions for use or consult
electronic instructions for use.
Biohazard
Collect separately.
Indicates separate collection for waste of
electrical and electronic equipment
required.
Cut or sever hazard
BD Kiestra™ InoqulA User's Manual

Symbol Meaning
Danger of crushing
Do not step
Earth terminal to ground
Electrical shock
Frame/chassis
Hot surface
Class 2 laser
Low clearance
Moving parts - pinch point
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.
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1 - Instructions for use guidance

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BD Kiestra™ InoqulA User's Manual