BD Kiestra ReadA Bedienungsanleitung

Kiestra™ ReadA

User's Manual

L011043(04)2024-01

446948

English

bd.com/e-labeling

BD Kiestra™ ReadA User's Manual

Change History

Revision Date Change summary

02 2020-02

Minor typographical corrections. Updated

Australian and New Zealand Sponsors

Addresses. Updated Module Operating

Requirements. Removed paragraph about

preventive maintenance in the Cleaning and

maintenance section.

03 2022-03

Updated ISO symbols. Added CH REP symbol

with address. Added serious incident and safe

disposal statements. Added information about

the incubator rack tags. Updated references to

CDC manual and ISO 8573-1. Added Ordering

information topic.

04 2024-01

Updated cover page to new format, moved

addresses to and updated CH REP address in

the Contacts topic. Added U.S. patent statement.

Updated Symbols glossary and Glossary topics.

Updated images in the Components topic and

added a note to the Calibrating the

BDKiestra™Optis™ camera topic.

BD, the BD Logo, BD Kiestra Optis, Kiestra, and Synapsys are trademarks of Becton,

Dickinson and Company or its affiliates. All other trademarks are the property of their

For U.S. patents that may apply, see bd.com/patents.

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.

Table of Contents

1 Instructions for use guidance 5

1.1 Customer release notes 5

1.2 Conventions 5

1.3 Notes, cautions, and warnings 6

1.4 Symbols glossary 6

1.5 Depiction of patient information 8

2 Introduction 9

2.1 Intended use 9

2.2 Module startup 9

2.3 Module description 9

2.3.1 BDKiestra™ ReadA incubator 9

2.3.1.1 Audible alerts and visual indicators 9

2.3.1.2 Components 10

2.3.2 Plate flow within theBDKiestra™ ReadA incubator 12

2.3.3 BDKiestra™ ReadA software application 13

2.3.3.1 General application layouts 14

2.3.3.2 Application toolbar 17

2.3.3.3 Application button bar 20

2.3.3.4 Machine tab 21

2.3.3.5 Logging tab 22

2.3.3.6 Debug Log tab 23

2.3.3.7 Sensor Charts tab 23

2.3.3.8 CSA tab 24

3 Configuration 25

4 Operation 27

4.1 Turning on module 28

4.2 Signing in and out 29

4.3 Startingoperation 30

4.4 Stopping operation 31

4.5 Turning off module 32

5 Cleaning and maintenance 33

5.1 Cleaning and disinfection 33

5.1.1 Frequency of routine cleaning 34

5.1.2 Cleaners and disinfectants 34

5.2 Cleaning methods 34

5.2.1 Dry cleaning 35

5.2.2 Wet cleaning/disinfecting 35

5.3 Cleaning strategies for incubator interior 35

5.3.1 Protocol A: Cleaning all racks with automated unloading 36

5.3.2 Protocol B: Cleaning all racks with manual unloading 37

5.3.3 Protocol C: Cleaning selected racks 38

5.4 Cleaning and maintaining BDKiestra™ ReadA components 40

5.4.1 Door seals 40

5.4.2 External Surfaces 40

5.4.3 Humidification pan 41

5.4.3.1 Cleaning the humidification pan 41

5.4.3.2 Refilling the humidification pan 42

5.4.4 BDKiestra™ Optis™ camera 43

5.4.4.1 Cleaning the BDKiestra™ Optis™ camera 43

5.4.4.2 Calibrating the BDKiestra™ Optis™ camera 46

5.5 Incidental cleaning 53

5.6 Decontamination 54

6 Troubleshooting 57

6.1 Resolving errors 57

6.2 Creating an error report 59

6.3 Error messages 60

6.4 BDKiestra™ Optis™ error messages 68

7 Contacts 71

8 Limited warranty 73

9 Installation requirements 75

9.1 Module specifications 76

10 Cleaning table 79

11 Ordering information 81

12 Glossary 83

13 Index 87

BD Kiestra™ ReadA User's Manual

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.

These instructions for use describe the use of the BDKiestra™ ReadA connected to

BDKiestra™ Track. Customers with a BDKiestra™ ReadA™Compact in a Work Cell

Automation (WCA) or a Total Lab Automation (TLA) solution are referred to the instructions for

use that are provided with their solution.

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.

Should a question arise that is not answered in these instructions, please contact BD.

See7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.

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

Importer

Date of manufacture

Use-by date

BD Kiestra™ ReadA User's Manual

Symbol Meaning

Batch code

Catalogue number

Serial number

OSHA NRTL safety approval, tested and certified to UL and CSA safety

standards by TÜV Rheinland®

OSHA NRTL safety approval, tested and certified to UL and CSA safety

standards by TÜV SÜD

Consult instructions for use or consult electronic instructions for use.

Alternating current

Biohazard

Caution

Collect separately.

Indicates separate collection for waste of electrical and electronic

equipment required.

Cut or sever hazard

Danger of crushing

Do not step

Do not use if package is damaged and consult instructions for use

Earth terminal to ground

Electrical shock

1 - Instructions for use guidance

Symbol Meaning

Frame/chassis

Hot surface

Class 2 laser

Low clearance

Moving parts - pinch point

On/Off

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.

BD Kiestra™ ReadA User's Manual

2 Introduction

2.1 Intended use

The BDKiestra™ ReadA is an in-vitro diagnostic device system which consists of an incubator

and a camera module. The ReadA is used to incubate plates and to create images of plates.

Plates are automatically removed from the incubator, photographed, and returned to the

incubator or transported to another specified destination.

The BDKiestra™ ReadAis indicated for use in the clinical laboratory.

WARNING

WEAR PERSONAL PROTECTIVE EQUIPMENT (LAB COAT, GLOVES, SAFETY

GLASSES) WHEN INTERACTING WITH THE MODULE.

2.2 Module startup

The BDKiestra™Track module provides electrical power to the BDKiestra™ReadA module

and must be powered on before trying to startup ReadA. Refer to the BDKiestra™ Track

User's Manual for details on turning on Track.

When power is applied to the ReadA module, the following operations are performed:

lHardware is checked and initialized.

lVarious sensors and subsystems are verified.

The module reports any problems that require user attention through alerts. If anything arises

that would prevent proper operation, the startup process is canceled.

BD recommends that the module remain powered on at all times except during certain

maintenance procedures.

2.3 Module description

This section describes the ReadA components, general flow of plates in and out of the ReadA

module, and the ReadA software application.

2.3.1 BDKiestra™ ReadA incubator

Plates are stored in racks at predefined incubation conditions in the ReadA incubator.

The ReadA incubator should remain turned on at all times to ensure specimen integrity.

2.3.1.1 Audible alerts and visual indicators

Each ReadA contains an audible alert, which is used to inform the user if a warning or error

situation has occurred within the module.

The user can also refer to the ReadA application via the Track graphical user interface (GUI),

or the instrument status tile on one of the dashboards in the BDSynapsys™ Informatics

Solution, for visual status indicators. Refer to the BDSynapsys™ Informatics instructions for

use for more details regarding the dashboards and viewing an instrument status.

See 6.1Resolving errors for more information on handling warning and error situations.

2.3.1.2 Components

Camera compartment

At predefined times, a plate is transported to the camera

compartment where photographs of the plate are taken

using a high-resolution camera and a variety of lightning

conditions. The images can be manually evaluated in the

BDSynapsys™ Informatics Solution, or can be used for

automated image evaluation using additional applications

provided by BD.

HEPA filter

Filters air around the camera

Humidification pan

Maintains adequate moisture levels for the plates in the

ReadA

Incubator

Incubates inoculated plates under controlled conditions.

The following notice on the incubator door indicates that

your ReadA has the CO2control option:

BD Kiestra™ ReadA User's Manual

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