BD Kiestra Track User Manual
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BD Kiestra Track User Manual

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Kiestra™ Track
User's Manual
BD Kiestra B.V.
Marconilaan 6
9207 JC Drachten, The Netherlands
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
L011042(03) 2021-10
446097, 446942
English
bd.com/e-labeling

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  • Page 1 Kiestra™ Track User's Manual BD Kiestra B.V. Marconilaan 6 9207 JC Drachten, The Netherlands 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...
  • Page 2 Light, and Regular Base specifications. BD, the BD Logo, Kiestra, and Synapsys are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners. © 2021 BD. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval...

  • Page 3: Table Of Contents

    2.3.1.2 Stacker element 2.3.1.3 Destacker element 2.3.1.4 Standard Connector element 2.3.1.5 Straight element 2.3.1.6 U-turn element 2.3.2 Plate flow 2.3.3 BD Kiestra™ Track GUI 2.3.3.1 General layout 2.3.3.2 Status view 2.3.3.3 BD Kiestra™ ReadA remote view 2.3.3.4 Utilities view 2.3.3.5 Notifications 2.3.3.6 Help 2.3.3.7...
  • Page 4 BD Kiestra™ Track User's Manual General cleaning procedure Cleaning components 5.4.1 Touchscreen 5.4.2 Sensors 5.4.3 Scanner windows 5.4.4 Conveyor belts 5.4.5 Stackers and Destackers 5.4.6 Blue covers 5.4.7 Internal and external surfaces Incidental cleaning Decontamination Troubleshooting Resolving errors Error, warning, and information messages...

  • Page 5: Instructions For Use Guidance

    EU Only: Users should 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.

  • Page 6: Symbols Glossary

    INFORMATION ON AN ACTIVITY WHICH POTENTIALLY COULD CAUSE INJURY TO THE USER IS PRESENTED AS A WARNING. 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...

  • Page 7: Depiction Of Patient Information

    1 - Instructions for use guidance 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...
  • Page 8 BD Kiestra™ Track User's Manual...

  • Page 9: Introduction

    If the startup procedures are successful, the module is ready to be used. BD recommends that the module remain powered on at all times except during certain maintenance procedures.
  • Page 10 BD Kiestra™ Track User's Manual Figure 1 — Example Track configuration with ReadA Figure 2 — Example Track configuration with InoqulA and BarcodA...
  • Page 11 Track is active, no user intervention is needed. White Note: the white light can be turned off by BD Technical Services. An error has occurred on that particular Track element. In case of a general Track error, the Track element on top of the Main Base cabinet, which houses the GUI monitor, is illuminated in red.
  • Page 12 BD Kiestra™ Track User's Manual Transport lanes All Track elements contain belts to move plates. These belts, which make up transport lanes, carry plates across each Track element and to other elements and modules. There are two types of transport lanes: a main lane and a side lane.
  • Page 13 2 - Introduction Icon Illustration Component Scanners Scanners (5) read the barcode on a plate. Plate carts Plate carts (6) store plates received from the Stacker element, and can hold up to 600 plates. 2.3.1.2 Stacker element The Stacker element is the endpoint destination for plates on Track, designed to collect plates to be retrieved by the user.
  • Page 14 (positive or negative) Configuration of the Stackers is done by BD Technical Services, taking into consideration the needs of each individual lab. NOTE During startup of Track, plates that are on the side lane of the Stacker element, but not yet stacked, are moved back onto the main lane.
  • Page 15 2.3.1.4 Standard Connector element The Standard Connector element transports plates to connected BD Kiestra modules. The Standard Connector element has one main lane and two side lanes that connect to the module: one side lane sends plates to the module, one receives plates from the module.

  • Page 16: Plate Flow

    BD Kiestra™ Track User's Manual 2.3.1.5 Straight element The Straight element transports plates over the distance of the element with only one main transport lane. It does not have the option of plates exiting or entering via side lanes. A Straight element is mainly used to complement another Track element like a Standard Connector, Stacker, or Destacker element.
  • Page 17 2 - Introduction From the side lane, the plate is guided onto the main lane by the Catcher, and merges with the rest of the plate traffic. The transport lane will move the plate from element to element, using sensors to keep track of and space the plate appropriately. NOTE In specific environmental conditions, a black agar plate may form condensation on the bottom, which may render the plate undetectable by...
  • Page 18 General layout The GUI is divided into three main sections: the header, body, and footer. Figure 3 — General layout Header The header contains the BD Kiestra module name, errors, notifications, and other secondary functions. Select to display the module errors. See 6.1 Resolving...
  • Page 19 This button only appears if an error or warning occurs. See 6.1 Resolving errors. Select Status to display the Track status. See 2.3.3.2 Status view. Select ReadA to display the ReadA remote view. See 2.3.3.3 BD Kiestra™ ReadA remote view. Select Utilities to display the Utilities view. See 5 Cleaning and maintenance. 2.3.3.2 Status view Status view is the default view of the Track application.
  • Page 20 BD Kiestra™ Track User's Manual Figure 4 — Status view Select a Track element, or zoom in to see a detailed view. NOTE Only Track elements are interactive in the Status view. Attached modules are for display purposes only and gray in color.
  • Page 21 2 - Introduction Color or Icon Meaning Destacker element Main Base cabinet with monitor Figure 5 — Status indicators in Status view...
  • Page 22 BD Kiestra™ Track User's Manual Element view The Track element view opens when an element is selected or zoomed in the Status view. It provides a detailed overview and schematic of the element and its components. Various icons are used to represent the Track components in the schematics:...
  • Page 23 2 - Introduction Component view The component view is displayed when a component is selected or zoomed in the Track element view. It provides a static image and details of the selected component. Figure 7 — Track component view The component and associated element are displayed directly beneath the image. The current state of the component controls is displayed.
  • Page 24 BD Kiestra™ Track User's Manual 2.3.3.3 BD Kiestra™ ReadA remote view ReadA remote view provides access to the user interface of connected ReadA modules. Refer to the BD Kiestra™ ReadA instructions for use for more information on the ReadA user interface. NOTE Only ReadA modules attached to Track are displayed.
  • Page 25 2 - Introduction 2.3.3.4 Utilities view Utilities view provides access to additional user functions. Figure 9 — Utilities view To prepare Track for cleaning, select Clean. The module will stop accepting new plates and start emptying plates from all Track elements. The user will be informed throughout the process of the number of plates that are remaining on Track and once all plates are removed from the module it will stop, but remain powered on.
  • Page 26 BD Kiestra™ Track User's Manual 2.3.3.5 Notifications Notifications icon in the application header displays warning and information notifications for the module. If enabled, an audible alert will also sound when a warning is triggered. The notification panel displays the active notifications, grouped by type. If there are multiple notifications of one type, the oldest notification is displayed at the top.
  • Page 27 2 - Introduction 2.3.3.6 Help Help icon in the application header provides access to version information. Figure 11 — Help panel Select to view the Help panel and the BD Kiestra™ Track UI (user interface) version and BD Kiestra™ Track MCS (machine control software) version.
  • Page 28 BD Kiestra™ Track User's Manual 2.3.3.7 User account user icon in the application header provides the ability to sign into and out of the application. See 4.3 Signing in and out for details. Figure 12 — My account panel If signed in, select to view the My account panel.

  • Page 29: Configuration

    Configuration Configuration icon in the application header provides access to the configuration settings. Only Language Settings is available to all users, with more advanced configuration options available to BD personnel only. Figure 13 — Configuration panel Select to view the Configuration panel.

  • Page 30: Language Settings

    BD Kiestra™ Track User's Manual Language settings The Language Settings option provides the ability to change the GUI language settings for all users. Only one language can be chosen at a time. Default language is English. Figure 14 — Language settings Select to view the Configuration panel.

  • Page 31: Operation

    Operation This section provides instructions for routine operation of Track. WARNING ALL PATIENT SPECIMENS AND MICROBIAL CULTURES ARE POTENTIALLY INFECTIOUS AND SHOULD BE TREATED WITH UNIVERSAL PRECAUTIONS. REFER TO THE CDC MANUAL BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES, 6TH EDITION, 2020, AS WELL AS OTHER RECOMMENDED LITERATURE.

  • Page 32: Turning On Module

    BD Kiestra™ Track User's Manual Turning on module Turning on Track provides electrical power to the Track elements and to all BD Kiestra™ modules connected to Track. Preparing Track Place an empty plate cart in front of the Stackers, lowering the side panel of the cart facing the Stackers.
  • Page 33 4 - Operation Turning on Track Figure 15 — Main Base cabinet power supply panel The power supply panel is located on the Main Base cabinet, below the monitor where the GUI is displayed. OPEN the compressed air by turning the left blue switch counterclockwise to the horizontal position.

  • Page 34: Starting Operation

    BD Kiestra™ Track User's Manual Starting operation When Track is powered up and the software is visible, the module can be started. Select Start in the footer of the GUI. If the module was recently powered down and is restarting, a message will display requesting the user to empty all Stackers and connect the plate carts in order for the startup process to continue.

  • Page 35: Signing In And Out

    User names and passwords are configured in the BD Synapsys™ Informatics Solution. Refer to the BD Synapsys™ Informatics Solution instructions for use for details on setting up user accounts. Figure 16 — Sign in option...

  • Page 36: Placing Plates In A Destacker

    BD Kiestra™ Track User's Manual Sign in Select Sign in in the top right of the GUI. Enter username and password. Select Sign In or press the Enter key. The Status view is displayed. The user name is displayed in the top right of the page. Select the User Name to display the role of the active user.

  • Page 37: Collecting Plates From A Stacker

    4 - Operation NOTE Ensure that all plates placed into a Destacker are properly labeled. Ensure that all black agar plates are free from condensation on the bottom of the plate when placing into a Destacker. Plates in the left most Destacker are destacked with highest priority. Collecting plates from a Stacker Plates are moved to a Stacker element when instructed by the software.

  • Page 38: Pausing Operation

    BD Kiestra™ Track User's Manual CAUTION When the plate cart or a compartment on the cart becomes full, a Stacker will error if it is unable to complete the push action. Plates may be cracked or damaged when this occurs.

  • Page 39: Opening Covers

    4 - Operation Opening covers Avoid opening covers unless absolutely necessary. Select Pause, Stop, or Clean as appropriate. Refer to 4.6 Pausing operation, or 2.3.3.4 Utilities view. Once Track is in an inactive state, lift the cover up until you hear it click into a locked position.
  • Page 40 BD Kiestra™ Track User's Manual When finished, press the cover latch up (1) to release the lock, then gently lower the cover into a closed position. WARNING WHEN OPENING OR CLOSING A COVER, BE CAREFUL TO WATCH FOR PINCH HAZARDS.

  • Page 41: Turning Off Module

    4 - Operation Turning off module BD recommends that Track remains powered on at all times except during certain cleaning and maintenance procedures. When turned off, Track will no longer accept new plates and will transport all current plates on the module to their destination. Once Track is completely empty, it will stop and the computer will shut down.
  • Page 42 BD Kiestra™ Track User's Manual Set the main power switch to OFF by turning the red switch (1) clockwise to the horizontal position. If applicable, CLOSE the CO by turning the right blue switch (2) clockwise to the vertical position.

  • Page 43: Cleaning And Maintenance

    Once every 12 months, preventive maintenance is required to be performed by BD authorized personnel. If a service contract is in place, BD will contact your laboratory when preventive maintenance is due. If there is no service contract, contact BD to schedule preventive...

  • Page 44: Cleaning And Disinfection

    5.1.2 Cleaners and disinfectants BD Kiestra recommends the use of a single agent that combines functions to facilitate fast and effective cleaning and disinfection. Any exceptions to that recommendation are specified in this protocol.
  • Page 45 BD should validate efficacy as well as compatibility with all module components. BD is not liable for damages to components caused by unvalidated cleaners. Cleaning methods There are three approaches to cleaning, all of which are acceptable in specific situations:...
  • Page 46 BD Kiestra™ Track User's Manual CAUTION Never spray or pour cleaner/disinfectant on or into the module or any part of the module. Always spray onto a microfiber wipe and then wipe the cleaner/disinfectant onto the module component. Do not use cleaning agent on computer screens, except when microbial contamination on the monitor surface occurs or is suspected.
  • Page 47 5 - Cleaning and maintenance To start Track again, perform the following steps: If it was removed, place the plate cart back in front of the Stackers, lowering the side panel of the cart facing the Stackers so that plates may be pushed onto it. Press the cart firmly against the Track module and engage the cart wheel locks to prevent any movement.
  • Page 48 BD Kiestra™ Track User's Manual Cleaning components 5.4.1 Touchscreen CAUTION Completely shut down the module when cleaning the touchscreen to prevent unwanted activation of functions. Clean with a microfiber wipe, moistened with water if needed. If microbial contamination occurs or is suspected on the monitor surface, disinfect with the recommended cleaning/disinfecting agent sprayed on a microfiber wipe.
  • Page 49 5 - Cleaning and maintenance 5.4.5 Stackers and Destackers Clean with water. If water is insufficient for adequate cleaning or disinfection, use the recommended disinfectant sprayed onto a clean microfiber wipe. 5.4.6 Blue covers Routinely clean with water. 5.4.7 Internal and external surfaces Vacuum the sides of Track if sides are noticeably dirty.
  • Page 50 BD Kiestra™ Track User's Manual Decontamination Decontaminate after spills, splashes, or obvious contamination, and before transporting the equipment out of the laboratory. WARNING CONSIDER ALL ORGANISMS AS POTENTIALLY INFECTIOUS AND HANDLE ACCORDING TO STANDARD MICROBIOLOGICAL PRACTICES, SPECIAL PRACTICES, AND SAFETY EQUIPMENT RECOMMENDED FOR BIOSAFETY LEVEL 2 (BSL-2) CONTAINMENT.*...
  • Page 51 5 - Cleaning and maintenance CAUTION Do not use abrasive or corrosive cleaners (including bleach) inside the equipment. Do not spray or pour liquid directly on surfaces. Exposure to vaporized decontamination methods is not advised, as this may cause damage to the equipment.
  • Page 52 BD Kiestra™ Track User's Manual...
  • Page 53 When an error occurs, operation of the entire Track is interrupted. Follow the instructions displayed in the GUI to resolve the error condition. CAUTION When the module notifies you of alerts and errors, you should immediately respond to the condition. If the recommended corrective actions do not solve the problem, contact BD.
  • Page 54 BD Kiestra™ Track User's Manual Error resolution When an error occurs, an overlay window immediately displays the error details to the user. Figure 17 — Error details screen List of errors, ordered oldest to newest. The details of the first error in the list display by default.
  • Page 55 Select Start, and Track will restart. NOTE If an error is not actually resolved when it is acknowledged as such, it may continue to be triggered. Error code. If the error cannot be resolved, contact BD and report the error code.
  • Page 56 BD Kiestra™ Track User's Manual Error displays on the GUI If the Error details screen is closed, but the module still has errors, the user can view the errors by selecting in the header section of the GUI or by locating the in the Status view.
  • Page 57 Track initialization failed: software SYSTEM-6013 Power cycle the Track. version is incorrect Track initialization failed: could SYSTEM-6014 Contact BD. not load Track Configuration Track initialization failed: SYSTEM-6015 Incorrect software version CIO Contact BD. board Track operations interrupted;...
  • Page 58 BD Kiestra™ Track User's Manual Error Code Error Message Error Resolution Locate the Catcher function plate A Catcher did not complete its CATCHERx-6032 and determine if something is initialization procedure blocking the function. Locate the Scanner function plate A Scanner did not complete its...
  • Page 59 6 - Troubleshooting Error Code Error Message Error Resolution Locate and inspect the Stacker A Stacker detected an lift; determine if there is STACKERx-6051 unexpected plate something blocking the plate detect sensor. Locate and inspect the Stopper; A Stopper detected an STOPPERx-6051 determine if there is something unexpected plate...
  • Page 60 BD Kiestra™ Track User's Manual Error Code Error Message Error Resolution DESTACKERx- Unable to destack: plate pusher 6061 not entirely retracted Locate and inspect the DESTACKERx- Unable to destack: plate not Destacker; remove all the plates 6062 moved onto the side track...
  • Page 61 6 - Troubleshooting Error Code Error Message Error Resolution UPS battery capacity low, please SYSTEM-I6025 Replace battery. replace battery...
  • Page 62 BD Kiestra™ Track User's Manual...
  • Page 63 Contacts Becton, Dickinson and Company BD Kiestra B.V. 7 Loveton Circle Marconilaan 6 Sparks, Maryland 21152 USA 9207 JC Drachten, The Netherlands Voice: 1-800-638-8663 Voice: +31 (0)512 540 623 Mail: Technical.Services@bd.com Mail: Lab_Automation_phone_support@bd.com bd.com 2100 Derry Road West Akasaka DS Building...
  • Page 64 BD Kiestra™ Track User's Manual...
  • Page 65 BD Kiestra™ Track resulting from the insertion or removal of cables that connect a module to systems other than those approved or supplied by BD or the failure of the owner to maintain reasonable care and precautions in the operation and maintenance of the module will void this warranty and terminate the obligations of the manufacturer as stated herein.
  • Page 66 BD Kiestra™ Track User's Manual...
  • Page 67 Track Main Base cabinet a direct connection with the System Control Unit (SCU) The module is to be installed and moved by BD representatives only. WARNING THE MODULE MUST BE ELECTRICALLY CONNECTED TO EARTH-GROUND AT ALL TIMES.
  • Page 68 100–240V, 50/60Hz, 1N~ or 2~ or 2N~ or 3~ or 3N~ Voltage fluctuations ± 10% of the nominal voltage Constant capacity, free of moisture and oil, minimum of class IV (DIN ISO 8573-1) CAUTION Only use the BD supplied power cord to connect the module.
  • Page 69 Measured at 1 m from surface of instrument, averaged over 30 seconds † The utility power supply for a BD Kiestra™ lab configuration enters through the Main Base cabinet. The Main Base cabinet, together with one or more Regular Base cabinets, distributes the utility power to the connected modules (ReadA, InoqulA, BarcodA, etc.) through circuit breakers.
  • Page 70 BD Kiestra™ Track User's Manual Storage Conditions Humidity 20–80% RH (non-condensing) Temperature -10°C – 40°C...
  • Page 71 10 - Ordering information Ordering information Catalog Number Item 446941 Frame 446942 Main Base Light 446943 Destacker 446944 U-turn 446945 Standard Connector 446946 Straight 446947 Stacker 446950 Plate cart 446096 Regular Base 446097 Main Base...
  • Page 72 BD Kiestra™ Track User's Manual...
  • Page 73 BD Kiestra™ in vitro diagnostic module used to automate specimen processing according to user-defined procedures and protocols. BD Kiestra™ ReadA BD Kiestra™ in-vitro diagnostic module used to incubate plates and create images of plates, and is intended to be used in clinical laboratories BD Kiestra™ Track BD Kiestra™...
  • Page 74 BD Kiestra™ Track User's Manual Instructions for use Refers to product instructions in printable form (e.g., user's manual PDF) or digital (e.g., online help). Light Emitting Diode. An electric light used in modern light fixtures because of its longevity and efficiency.
  • Page 75 Biological material obtained from a patient for the purposes of a diagnostic test Stacker element Element designed to collect plates to be retrieved by the user. Standard Connector element Element designed to transport plates from Track to connected BD Kiestra™ modules. Stopper Component designed to stop a plate from traveling. Straight element Element designed to transport plates over the distance of a Track element with only one main transport lane and no option of plates exiting or entering via side lanes.
  • Page 76 BD Kiestra™ Track User's Manual Uninterruptible Power Supply Universal Serial Bus...
  • Page 77 Index Cleaning blue covers cleaners and disinfectants cleaning procedures conveyor belts decontamination disinfection dry cleaning frequency incidental internal and external surfaces methods Scanner windows sensors Stackers and Destackers touchscreen wet cleaning/disinfecting Configuration language settings Contacts Conventions Depiction of patient information Installation requirements...
  • Page 78 BD Kiestra™ Track User's Manual Intended Use Maintenance preventive maintenance Module specifications environmental requirements module operating requirements physical dimensions storage conditions utility requirements Operation collecting plates from a Stacker opening covers pausing operation placing plates in a Destacker signing in and out...
  • Page 79 12 - Index Track elements Base cabinets components Destacker element indicators and audible alarms Main Base cabinet overview Regular Base cabinet Stacker element Standard Connector element Straight element transport lanes U-turn element Track graphical user interface general layout Help Notifications ReadA remote view Status view User account...
  • Page 80 BD Kiestra™ Track User's Manual...

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