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BD Kiestra IdentifA User Manual

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Kiestra™ IdentifA
User's Manual
Becton, Dickinson and Company
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.
66 Waterloo Road
Macquarie Park NSW 2113, Australia
Becton Dickinson Limited
14B George Bourke Drive
Mt. Wellington Auckland 1060, New Zealand
L011038(07) 2021-12
444063
English
bd.com/e-labeling

Table of Contents

Questions and Answers:

BD Kiestra IdentifA Specifications

General IconGeneral
BrandBD
ModelKiestra IdentifA
CategoryLaboratory Equipment
LanguageEnglish

Summary

Instructions for Use Guidance

Conventions

Defines text formatting like bold and italics used in the manual for clarity.

Notes, Cautions, and Warnings

Explains how safety messages (NOTE, CAUTION, WARNING) are presented and their meanings.

Symbols Glossary

Lists and explains symbols used for safety, compliance, and device identification within the manual.

Depiction of Patient Information

Clarifies that patient data shown is illustrative and not actual clinical information.

Introduction

Intended Use

Describes the BD Kiestra™ IdentifA module's purpose for specimen preparation and organism identification.

Module Description

Details the IdentifA module, user interface, and functional areas of the system.

User Interface

Explains the IdentifA module's touchscreen interface for workflow actions and data entry.

Functional Areas

Identifies the main areas of the IdentifA module for colony picking and suspension preparation.

Precautions, Limitations, Warnings

Outlines crucial safety guidelines, operational limitations, and potential hazards of using the device.

Configuration

Changing Settings

Guides users on how to modify system settings for audible alerts, checks, and wait times.

Audible Alerts

Details how to configure the audible buzzer for system notifications and errors.

Schedule Daily Nephelometer Check

Specifies the time for the daily nephelometer check after module startup.

Cuvette Array Wait Time

Specifies the time the system waits for cuvette arrays before proceeding with target spotting.

Target Processing Wait Time

Defines the time the system waits before finishing target spotting if no new specimens arrive.

Operation

Startup

Details the steps for powering on the IdentifA module and initial system checks.

Login

Explains how to log in to access basic and advanced functions of the IdentifA module.

Starting Normal Operation

Guides users on how to begin routine specimen processing after startup.

Responding to Notifications

Describes how the system alerts users to events and the meaning of different notification indicators.

Pausing Operation

Explains how to temporarily halt module operations for maintenance or other tasks.

Managing Reagents and Consumables

Covers tracking and replenishing essential reagents and consumables like pipette tips.

Pipette Tips

Instructions for loading new pipette tips into the module's drawers.

Cuvette Arrays

Provides instructions for replacing cuvette arrays, including indicator light meanings.

Replacing Reagents

Guides users on how to replace reagent vials, including checking cap tightness.

MALDI Targets

Lists compatible MALDI targets and notes for their use.

Loading MALDI Targets

Step-by-step guide for loading MALDI targets into the module, including barcode scanning.

Stopping Operation

How to safely stop the module's operation for maintenance or calibration.

Shutdown

Procedure for properly shutting down the IdentifA module after specimen processing is complete.

Cleaning and Maintenance

Waste Management

Procedures for handling and disposing of liquid and solid waste generated by the module.

Cleaning and Disinfection

Explains the importance and methods for cleaning and disinfecting the module components.

Cleaners and Disinfectants

Lists recommended and compatible cleaning agents and disinfectants for the module.

Cleaning Methods

Outlines different cleaning approaches: dry, wet, and combined cleaning techniques.

Cleaning Components

Details specific cleaning procedures for individual module components.

Cleaning After Large Spills

Procedures for cleaning up spills in specific areas of the module.

Decontamination

Guidelines for decontaminating the module after spills or contamination.

Routine Maintenance

Outlines essential routine maintenance tasks for the module.

Nephelometer Calibration

Describes the monthly and daily calibration procedures for the nephelometer.

Troubleshooting

Responding to Errors

Guides users on how to react to system alerts and errors promptly.

Error Messages

Lists common error codes, messages, and their corresponding resolution descriptions.

Performance Characteristics

Colony Pick Accuracy

Evaluates the accuracy of the IdentifA module in picking designated colonies from culture plates.

Identification Equivalency

Assesses the accuracy of organism identification using samples prepared by IdentifA.

Reproducibility

Examines the consistency of organism identification results across modules, operators, and days.

Limit of Detection

Evaluates the module's ability to achieve expected identification at specified microbial suspension levels.

Cross-Contamination

Assesses the potential for cross-contamination between samples within the IdentifA module.

Contacts

Limited Warranty

Installation Requirements

Module Specifications

Lists physical dimensions, weight, and environmental requirements for installing the module.

Ordering Information

Glossary

Index

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