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7 Loveton Circle Sparks, Maryland 21152 USA Benex Limited Pottery Road, Dun Laoghaire Co. Dublin, Ireland BD Switzerland Sàrl Terre Bonne Park – A4 Route de Crassier 17 1262 Eysins, Switzerland Australian and New Zealand Sponsors: Becton Dickinson Pty Ltd.
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Added Error messages. BD, the BD Logo, Kiestra, ReadA, and Synapsys are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners.
Conventions Notes, cautions, and warnings Symbols glossary Depiction of patient information Introduction Intended use Summary and explanation of the test Module startup Module description 2.4.1 BD Kiestra™ IdentifA module 2.4.2 Connection modules 2.4.3 User interface 2.4.3.1 Status view 2.4.3.2 Drawers 2.4.3.3 Deck overview 2.4.3.4...
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.
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...
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...
- time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens. The BD Kiestra™ IdentifA is indicated for use in the clinical laboratory with the BD Kiestra™ ® ReadA™ Compact and Bruker MALDI Biotyper CA System to aid in the diagnosis of bacterial and fungal infections.
CA system. 2.4.2 Connection modules Connection modules connect IdentifA to the BD Kiestra™ solution that is implemented in your laboratory, or allow operation of IdentifA as a standalone module. BD Kiestra™ IdentifA Manual Infeed module The IdentifA Manual Infeed module accepts stacks of barcode-labeled plates that are manually placed on the IdentifA track.
2 - Introduction TLA connection module The TLA connection module connects IdentifA to the TLA track. Plates are automatically transported to IdentifA. Processed plates are directed to a Stacker at the front of the TLA connection module. Processed plates are removed manually from the Stacker, and can be placed on the TLA track, or can be discarded.
BD Kiestra™ IdentifA User's Manual 2.4.3.1 Status view After a user logs in, the Status view is displayed by default. Select to open an overlay window that displays system errors. A badge on the icon indicates the number of unresolved system errors.
2 - Introduction Schematic of the plate infeed. The Stacker and/or Destacker will display depending on the type of connection module. The color indicates notifications related to the particular Stacker or Destacker. Select for detailed layout of infeed module. color indicates notifications related to plates. Select to see the individual notifications.
BD Kiestra™ IdentifA User's Manual 2.4.3.3 Deck overview Select the area above the drawers on the Status view to navigate to the IdentifA deck overview. The color of the display elements indicates notification status. Select an element for detailed information.
2 - Introduction 2.4.3.4 Progress view The Progress view displays the progress of filling target spots and dilution of suspensions. Shows the number of spots the module has left to complete. A target spot is not considered complete until each dispensing step and dry time for isolate suspension, formic acid, matrix, and BTS is completed.
BD Kiestra™ IdentifA User's Manual 2.4.3.5 Utilities view The Utilities view provides access to wizards for cleaning and maintenance tasks. 2.4.4 Functional areas IdentifA consists of an area for picking colonies from plated media (1) and an area for creating...
2 - Introduction 2.4.4.1 Picking colonies Stacks of plates are either manually placed on the IdentifA track (1, IdentifA Manual Infeed module), or individual plates are automatically transported from the WCA/TLA solution to the IdentifA track. The IdentifA track transports the plate to the plate shifter (2). The plate shifter places the plate on one of two picking stations (3).
BD Kiestra™ IdentifA User's Manual When suspensions for all isolates have been prepared, the plate is returned to the IdentifA track and is transported to the Stacker at the front of the connection module (7). The pipette tip is disposed in the waste bin (8).
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If the final turbidity is greater than or equal to 0.2 McFarland, the suspension is accepted for MALDI-TOF MS identification. The MALDI target is spotted. If the final turbidity is lower than 0.2 McFarland, a target is spotted, and BD Synapsys™ Informatics notes that the turbidity of the suspension was low.
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Two (2) microliters of BTS (13, yellow cap) is dispensed at two additional spots to serve as controls (the number of additional spots is configurable in BD Synapsys™ Informatics). One microliter of formic acid (12, blue cap) is added to each spot with specimen material.
No black or dark colored agar should be used in the BD Kiestra™ ReadA™ Compact if colonies need to be picked on BD Kiestra™ IdentifA. Only one BD supplied 40 mm label may be present on a plate. Never place two labels onto a plate as this can lead to misalignment at the colony picking position.
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Suspensions of yeast species prepared with the BD Kiestra™ IdentifA may not produce a high confidence mass spectrometry result. If a Low Confidence Identification or No Identification Result is obtained or if yeast is suspected, follow the instructions in the ®...
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The BD Kiestra™ ReadA™ Compact module is required for use in conjunction with the BD Kiestra™ IdentifA to obtain the digital image the IdentifA uses for colony selection and target preparation. Performance of the BD Kiestra™ IdentifA has been established with the BD Kiestra™...
A shorter time means quicker output, but when plates arrive at irregular intervals at the module, this could result in higher consumable usage. BD advises a value of 600 seconds (10 minutes).
IdentifA within the specified time. A shorter time means quicker output of the target, but when plates arrive at irregular intervals at the module, this could result in fewer spots per target. BD advises a value of 1800 seconds (30 minutes).
4 - Operation Operation Prior to starting IdentifA operation, refer to the Ordering tests processed on the BD Kiestra™ IdentifA module topic in the BD Synapsys™ Informatics Solution instructions for use. This section provides instructions for routine operation of IdentifA. Startup The main power switch and air pressure switch are on the left side of the IdentifA module, above the plate infeed.
BD Kiestra™ IdentifA User's Manual NOTE During startup, the System alerts view only displays notifications that prevent normal operational use. After a successful startup, all notifications are displayed. During operation, IdentifA monitors settings and parameters, and displays system errors and notifications as they occur.
4 - Operation Select Mute Buzzer to turn off the audible alert. Select in the application header to display the System alerts view. Address each alert as appropriate. Select to view the entire list of alerts. Select Clear to clear the alert list. Pausing operation The safety covers are always locked when the module is in operation.
BD Kiestra™ IdentifA User's Manual When a module needs to access consumables from a drawer that is open, processing will wait until the drawer is closed and the consumables become available. If a drawer is open for longer than five minutes, a warning notification is displayed.
A red indicator indicates that an error has occurred during processing of one of the suspensions. Scan the barcode of the cuvette array with the BD Synapsys™ Informatics scanner to obtain more information. Place new cuvette arrays into the empty slots.
BD Kiestra™ IdentifA User's Manual In the user interface, select the bottle icon to open the bottle overview. Place caps on empty deionized water bottles. Remove the empty bottles. Scan the barcodes on new deionized water bottles. Place new deionized water bottles into the bottle holders.
4 - Operation Select FULL BOTTLE, 2/3 BOTTLE, or 1/3 BOTTLE to confirm that a reagent vial was refilled or NO if the vial was not refilled. Close the reagent lid. Close the IdentifA cover. Select to resume operation. 4.7.4.1 Matrix solution Prepare the US IVD HCCA portioned matrix solution as described in the Bruker MALDI ®...
BD Kiestra™ IdentifA User's Manual NOTES Automated processing on IdentifA requires BTS to be diluted with 100 μL of solvent. Avoid foaming of the solution. Incubate the US IVD BTS solution for five (5) minutes at room temperature and repeat mixing by pipetting up and down at least 20 times.
For US customers: use FDA cleared targets only. NOTE Do not place adhesive labels on the US IVD 48 Spot Target. Do not drop or scratch the target. IdentifA communicates target information via BD Synapsys™ Informatics to the Bruker MALDI ® Biotyper CA system.
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BD Kiestra™ IdentifA User's Manual In the Target Plate Drawer Overview, select or enter barcode. The onscreen keyboard is displayed. Type the target identifier in the Barcode field. Re-type the target identifier in the Repeat field. If the entered information is verified,...
Bruker MALDI Biotyper CA system. CAUTION Only one BD supplied 40 mm label may be present on a culture plate. Never place two labels onto a plate. Never remove and reapply a label to a plate. These actions can lead to misalignment of the culture plate at the colony picking position.
BD Kiestra™ IdentifA User's Manual Plates with errors are transported to the error plates output track below the Stacker. Scan each plate barcode with the BD Synapsys™ Informatics hand scanner and follow the instructions provided by BD Synapsys™ Informatics. 4.7.6.2 Loading culture plates on IdentifA in WCA or TLA If IdentifA is connected to the WCA or TLA track, culture plates are automatically transported to IdentifA.
Once every 6 months, preventive maintenance is required to be performed by BD authorized service 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 your BD representative to schedule preventive maintenance.
BD Kiestra™ IdentifA User's Manual 5.1.2 Solid waste CAUTION Waste bins may contain biohazard waste. Follow Good Laboratory Practices and Universal Precautions at all times. All materials should be disposed of properly as required by your institution and regional applicable laws, regulations, and policies.
5.2.2 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.
BD Kiestra™ IdentifA User's Manual CAUTION Use only the recommended cleaner/disinfectants. Follow the manufacturer’s instructions for proper preparation (if necessary) and use of the cleaner/disinfectants used in your laboratory. There are three approaches to cleaning, all of which are acceptable in specific situations:...
WHEN CLEANING THE DECK AND AREA AROUND THE MUCOID STRAIN CUTTER, HOLD THE CUTTER IN ITS DEFAULT POSITION. MAKE SURE NOT TO TOUCH OR BEND THE CUTTING WIRE OUT OF POSITION. IF THE CUTTING WIRE IS BENT, CONTACT BD. DO NOT TURN ON THE MODULE.
BD Kiestra™ IdentifA User's Manual 5.5.1 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.
5 - Cleaning and maintenance 5.5.6 Nephelometers NOTE The user must be logged in as Lab Technologist II or Lab Supervisor to access the Nephelometer Cleaning wizard. Select if IdentifA is running. Select Nephelometer Cleaning in the Utilities view. Follow the instructions in the wizard to position the nephelometers for cleaning. Remove the nephelometer covers.
If a large spill occurs in the drawer area, clean the drain output. 5.6.2 Nephelometer area If a large spill occurs in the nephelometer area, contact BD. 5.6.3 Deck If a large spill occurs on the deck, the top deck plates can be removed for cleaning. To remove the top deck plates: Remove all caps from the deck by placing them onto the associated bottles and vials.
5 - Cleaning and maintenance 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.* BSL-2 PRACTICES INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: WEAR GLOVES AND LAB COAT WHEN HANDLING POTENTIALLY...
If the daily verification fails, the calibration wizard must be performed. NOTE BD recommends performing the daily verification outside normal operation hours. To perform nephelometer calibration, select Nephelometer calibration in the Utilities view and follow the instructions.
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. Depending on configuration settings, a buzzer may sound when error conditions occur. The Errors overview is displayed.
Follow the instructions to resolve each error condition. NOTE Report the complete error code and location to BD if assistance is needed to resolve an error. When an error condition has been resolved, select Error Resolved to close the alert pane.
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An unexpected plate lid was detected in 5032 Remove the plate lid. the pick area. 5033 The plate feed module is not enabled. Contact BD. Two or more plate feed modules are 5034 Contact BD. enabled. A plate did not arrive within the expected 5036 Remove the plate and check for obstructions.
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Error during mucoid cutting. Check the deck for any contamination. 5047 Unable to heat the mucoid cutter wire. Check for contamination, then contact BD. 5048 The mucoid cutter wire is broken. Check for contamination, then contact BD. Plates detected on plate feed during...
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BD Kiestra™ IdentifA User's Manual Error Error Message Resolution Description Code 5120 Nephelometer calibration error. Run the Nephelometer calibration wizard. 5121 Nephelometer calibration error. Run the Nephelometer calibration wizard. Error occurred while moving a robotic 5122 Check for and remove any blocking objects.
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An error occurred during pipettor 5151 Manually remove the pipette tip. initialization. 5152 Unable to dispose a pipette tip. Manually remove the pipette tip. 5153 Internal communication error. Contact BD. 5154 Internal communication error. Restart IdentifA. 5155 Invalid configuration. Contact BD. 5156 Internal error.
7.5 Cross-contamination Colony pick accuracy This study was performed to evaluate the accuracy of the BD Kiestra™ IdentifA to pick the colonies designated by the operator in the digital image obtained by the BD Kiestra™ ReadA™ Compact. Two organisms, E. coli and Streptococcus pyogenes, were inoculated on 200 plated media and processed on the BD Kiestra™...
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BD Kiestra™ IdentifA User's Manual BD Kiestra™ IdentifA agreement in comparison to expected identity for Gram negative bacteria MALDI-TOF Log (Score) Concordant Discordant No Identification Expected MALDI Report 1.70- 1.70- ≥ 2.00 ≥ 2.00 < 1.70 1.99 1.99 Peaks Acinetobacter baumannii/nosocomialis group Bacteroides fragilis Campylobacter coli...
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6 Identified as Escherichia species; manual result provided Escherichia vulneris (log score of 2.03) 7 Identified as Bacteroides species; manual result provided unspecified (log score of 1.6) BD Kiestra™ IdentifA agreement in comparison to expected identity for Gram positive bacteria MALDI-TOF Log (Score)
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4 Identified as Streptococcus mitis/oralis group; concordant with the result obtained with manual sample preparation 5 Identified as Streptococcus agalactiae; concordant with the result obtained with manual sample preparation BD Kiestra™ IdentifA agreement in comparison to expected identity for yeast MALDI-TOF Log (Score)
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Sample processing with the Bruker manual eDT method yielded 387 (97.5%) of the isolates matching the expected identification. Nine of the organisms yielded the same identification when processed on BD Kiestra™ and by the manual eDT method; however, they did not match expected results (noted with an * in the table below).
Bruker MALDI Biotyper CA system for identification. All except two strains had a log (score) ≥ 2.00, ≥ 95% of the time between BD Kiestra™ IdentifA modules, replicates, groups, and lots. The overall agreement between BD Kiestra™ IdentifA modules, operators, lots, and days is ≥ 96%. Corynebacterium jeikeium and Candida albicans reproducibility were evaluated by manual preparation using the eDT method and also did not meet the acceptance criteria of >...
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>95%. Due to the results of the Bruker manual eDT method, these strains were not suitable isolates for a reproducibility study and were excluded from the BD Kiestra™ IdentifA reproducibility results. BD Kiestra™ IdentifA reproducibility by operator, instrument, lot, and day...
BD Kiestra™ IdentifA User's Manual Limit of detection This study was performed to evaluate the ability of the BD Kiestra™ IdentifA to obtain the expected organism identification with microbial suspensions at or above the limit of detection as defined for the BD Kiestra™ IdentifA. Organism suspensions of at least 0.2 McFarland (0.2–0.3 McFarland), at Bruker's limit of detection, were inoculated onto eight MALDI target...
Cross-contamination This study was performed to evaluate the potential for cross-contamination using the BD Kiestra™ IdentifA within and between culture plates and between spots on the MALDI target. One hundred plated media were inoculated with a strain of Staphylococcus aureus, and one hundred plated media were inoculated with a strain of Klebsiella pneumoniae.
BD Kiestra™ IdentifA 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.
Environments which exceed these limits could adversely affect the performance of the module components. The module requires a network 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.
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100–240 V, 50/60 Hz, 1N~ or 2~ Voltage fluctuations +/- 10% of nominal voltage Constant capacity, free of moisture and oil, minimum class IV (DIN ISO 8573-1) CAUTION Only use the BD supplied power cord to connect the module. Module Operating Requirements Specifications Audible noise <...
Glossary BD Kiestra™ TLA solution InoqulA+, ReadA™ Compact, and ErgonomicA modules and software integrated into one solution for total laboratory automation BD Kiestra™ WCA solution InoqulA+ and ReadA™ Compact modules integrated into one solution for work cell automation BD Synapsys™ Informatics Solution...
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BD Kiestra™ IdentifA User's Manual Graphical User Interface. A type of software display screen that allows users to interact with electronic devices through icons and visual indicators. Identity Management user authentication software Incubation program The incubation and imaging steps for a particular medium Instructions for use Refers to product instructions in printable form (e.g., user's manual PDF) or digital (e.g., online...
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12 - Glossary Programmable Logic Controller Sample A specimen that has been prepared for diagnostic testing Semi-automated (SA) processing Inoculation is performed manually and inoculum spreading onto plates is automated. Skill A destination or condition assigned to a Stacker Specimen Biological material obtained from a patient for the purposes of a diagnostic test Test Laboratory Code Uninterruptible Power Supply...
Index Cleaning cleaners and disinfectants conveyor belts deck decontamination disinfection drawer area drawers frequency general cleaning procedure internal and external surfaces lifting and rotating cylinders MALDI target locations methods 43-44 module components nephelometer area nephelometers safety covers Scanner windows sensors spills Stackers and Destackers suction cups...
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BD Kiestra™ IdentifA User's Manual controlled environment target plate drying times cuvette array prep count cuvette array wait time maximum samples on target nephelometer check target processing wait time Connection modules IdentifA Manual Infeed module TLA connection module WCA connection module...
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13 - Index Maintenance nephelometer calibration pipette verification preventive routine MALDI targets force cleaning loading unloading Module specifications Opening drawers Pause Performance characteristics colony pick accuracy cross-contamination identification equivalency limit of detection reproducibility Pick area Pipette tips Precautions...
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