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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BD Kiestra™ InoqulA User's Manual

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2 Introduction
This section covers the following topics:
l2.1Intended use
l2.2Module description
l2.2.1Deck layout and plate path
l2.2.2User interface
2.1 Intended use
The BDKiestra™ InoqulA is an in vitro diagnostic device system which is intended to automate
specimen processing according to user-defined procedures and protocols. In Fully Automated
(FA) mode, this includes opening and closing sample container(s), barcoding, inoculating and
streaking plated media, and inoculating tubes and slides. In Semi-Automated (SA) mode,
dishes are automatically selected, barcoded, streaked in a pre-configured pattern while the
user manually inoculates dishes, tubes and slides. The InoqulA is indicated for use in the
clinical laboratory.
2.2 Module description
The standalone InoqulA solution consists of:
lBarcodA module: stores and sorts plated media for specimen inoculation; applies barcode
labels to plates for specimen traceability
lInoqulA FA module: fully automated processing of liquid specimens; including agitation of
specimen container, decapping and recapping, pipette based inoculation, and bead
insertion
lInoqulA SAmodule: manual specimen inoculation and spreading for all specimen types
After the barcode label is applied, the plate is ready for processing.
During fully automated (FA) processing, plates are supplied by BarcodA depending on the
required analysis. InoqulA agitates the specimen, uncaps the specimen, aspirates specimen
material from the container; and inoculates plates, broth tubes, and slides. Following
inoculation, plates are transported to the spreader where the inoculum is spread over the agar
surface, using a magnetically controlled bead. Slides are labeled and stored in the Slide
Processing Module (SPM) until the inoculum has dried. Individual dried slides may be ejected
from the SPM for priority processing.
During semi-automated (SA) processing, inoculation is performed manually and inoculum
spreading onto plates is automated. The user scans a specimen barcode, plates are selected
and barcoded by BarcodA, then InoqulA adds a bead (or two beads for bi-plates) to all plates
and transports them to the inoculation position. The user inoculates the plates, broth tubes, or
slides, then InoqulA spreads the inoculum on the plates using the magnetically controlled
bead.
Up to four plates can be spread simultaneously according to preset streaking patterns.
Following inoculation and spreading, plates are sorted in output stackers according to selected
conditions (e.g., O2, CO2, MA or Ø2incubation, or medium type).

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2.2.1 Deck layout and plate path
1. Destacker positions: The user loads stacked media plates in the user defined destacker
positions. Plates are dispensed and travel on the belt to be processed.
2. Stacker positions: After processing, the inoculated plates are stacked in the stacker
positions. The stackers stack similar plates by incubation condition (O2, CO2), or by media
type.
3. Plate barcode buffer position: Plates stop at this position for label application.
4. Plate barcode printer: Prints and applies the label to the plate.
5. Plate barcode scanner: Identifies the plate that is being supplied to the FA module.
6. Buffer positions (left and right): Plates can be queued in the left buffer position, after which
they are supplied for bead introduction and automatic inoculation. Plates can be queued in
the right buffer position, after which they are supplied for automatic streaking or manual
inoculation at the SAmodule.
7. Bead dispenser and plate detector: A bead is dropped into the plate. When using bi-plates
the bi-plate detector is used to position the plate correctly for the bead dispenser.
BD Kiestra™ InoqulA User's Manual

8. FA module inoculation position: Liquid specimen material is aspirated with the pipettor and
applied to a plate, tube, or slide.
9. SA module inoculation position: Plates are supplied for manual inoculation at the
workstation. After the specimen is verified, plate lids are opened automatically. Any
required tubes and slides may be manually labeled and inoculated here.
10. Streaking position: Specimen material in the plate is streaked according to a pattern
selected in the analysis protocol. The bead is then removed.
11. Removal of plates: Plates are removed by the rear conveyor belt and sent to output
stackers.
12. Singulator: Controls the plate queue to be delivered to the defined stacker position.
Stacker, destacker, specimen rack, pipette tip rack, and streaking position numbers are
identified on the image below:
2.2.2 User interface
The BarcodA user interface is a touchscreen on the BarcodA module.
The InoqulA user interface is a touchscreen on the SA module.
Touch the appropriate screen element to perform a workflow action.
To enter data, use the virtual keyboard embedded in the display.
NOTE
Depending on your module configuration, some user interface elements may differ
slightly from the following depictions.
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2 - Introduction

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2.2.2.1 BarcodA user interface
After a user logs in, the Instrument Status view is displayed by default.
Instrument Status view
1. opens a side window that displays notifications. A badge on the icon indicates the
number of notifications.
2. displays the configuration menu.
3. displays software version information.
4. opens the user login menu.
5. starts normal operation.
6. pauses normal operation.
7. Status view
8. Inventory view
9. Worklists view
10. Utilities view
11. Default Template enables users to create, delete, or change the media template.
12. Schematic of the destackers and stackers. The color indicates the notification status.
Select to view destacker/stacker details.
BD Kiestra™ InoqulA User's Manual

Stacker Details view
The following information is displayed and may be edited in the Stacker Details view:
lDetails - stacker name, stacker height, and status
lMedia Protocol assigned to the stacker
lIncubation Type assigned to the stacker
Destacker Details view
The following information is displayed and may be edited in the Destacker Details view:
lDestacker Availability - used to enable or disable a destacker
lDetails - media name
lNumber of plates (0–3) that may be added to the destacker after the initial stack is depleted
- used when a small number of plates are needed to complete processing
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2 - Introduction

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Inventory view
A colored notification indicator appears on the affected pane if user intervention is required.
Worklist view
A logged in user can view a detailed list of requested plates.
Utilities view
The following options are available in the Utilities view:
lStop BarcodA enables users to stop the module before cleaning or before turning off the
main power.
BD Kiestra™ InoqulA User's Manual

lBackup and Restore Database enables users to specify the time of the daily database
backup.
lPrinter Alignment enables users to align the print on plate barcode labels.
2.2.2.2 InoqulA user interface
After a user logs in, the Status tab is displayed by default.
Instrument Status view
1. opens a side window that displays notifications. A badge on the icon indicates the
number of notifications.
2. displays the configuration menu.
3. displays software version information.
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2 - Introduction

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4. opens the user login menu.
5. starts normal operation.
6. pauses normal operation.
7. Status view
8. Inventory view
9. SA Mode view
10. Utilities view
11. Schematic of specimen racks
12. Schematic of the bead dispenser
13. Schematic of the pipette tip waste container
14. Schematic of the SPM slide rack
15. Schematic of pipette tip racks
16. Schematic of bead waste containers
17. Schematic of the SAslide dispenser
18. Schematic of the desktop printer
19. Schematic of the Stat slide output port
20. Schematic of the Slide Processing Module (SPM) printer ink cartridge
Rack Details view
The Rack Details display indicates the status of each rack position.
BD Kiestra™ InoqulA User's Manual

Slide Rack Details view
The Slide Rack Details display indicates the status of each slide position.
Inventory view
A colored notification indicator appears on the affected pane if user intervention is required.
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2 - Introduction

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Utilities view
The following options are available in the Utilities view:
lStop InoqulA enables users to stop the module to replenish consumables, before cleaning,
or before turning off the main power.
lLock SAGuards locks and unlocks the shifter cover, printer cover, and bead waste drawer.
lBackup and Restore Database enables users to specify the time of the daily database
backup.
lRelabel Broth Tubes enables users to print labels with user defined information for
processed broth tubes.
lPrint Broth Tube Labels enables users to print a specific quantity of broth tube labels.
lDiagnostics enables users to perform bead dispenser troubleshooting and SPM
maintenance
BD Kiestra™ InoqulA User's Manual