BD-MAX System Users Manual ver 2.8 Sept 2012

BD MAX System User’s Manual

Change History Revision Date

Pages

Reason

(2012/03) (01)

All

New product manual

(2012/05) (02)

All

Updates for software version 2.7; remove Canada from Version

(2012/09) (03)

All

Updates for software version 2.8

The BD MAX PCR cartridge is manufactured under license from Caliper Life Sciences, Inc. Alconox is a trademark of Alconox, Inc. Cy5 and Cy5.5 are registered trademarks of GE Healthcare Bio-Sciences DNA AWAY is a trademark of Molecular BioProducts FAM, HEX, and ROX are trademarks of Applera Corp. BD, BD Logo, and BD MAX are trademarks of Becton, Dickinson and Company. © Copyright Becton, Dickinson and Company, 2011-2012. 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, 7 Loveton Circle, Sparks, Maryland, 21152, United States of America.

ii

8086643(2012/09) (03)

u Preface

Contents 1 – Introduction 1.1

Intended Use ... 1-1

1.2

Overview ... 1-1

1.3

System Overview ... 1-5 1.3.1 1.3.2 1.3.3

BD MAX Instrument ... 1-5 Peripherals... 1-8 BD MAX IVD Assays... 1-9

1.4

Manual Structure ... 1-11

1.5

Use of this Manual ... 1-11

1.6

Conventions ... 1-12 1.6.1 1.6.2 1.6.3

1.7

Buttons, Displays, Fields, Messages ... 1-12 Symbols Used on the Equipment... 1-12 Notes, Cautions, and Warnings ... 1-13

Precautions, Limitations, Cautions, Warnings... 1-14 1.7.1

Summary of Cautions and Warnings ... 1-15

2 – Installation 2.1

General ... 2-1

2.2

Instrument Specifications ... 2-2

2.3

Instrument Installation ... 2-4 2.3.1 2.3.2 2.3.3 2.3.4

2.4

Software Setup (Administration) ... 2-5 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7 2.4.8

2.5

Installation Policy ... 2-4 Site Location ... 2-4 System Calibration... 2-4 User Training ... 2-4

Users Display... 2-6 Date & Time Display ... 2-9 Language Display ... 2-11 Printer Display... 2-13 Assays Display... 2-15 UDP Protocols Display... 2-19 Configuration Display... 2-20 External Devices Display ... 2-22 2.4.8.1

Pre-warm Station Window ... 2-22

2.4.8.2

LIS Configuration Window ... 2-22

2.4.8.3

Assurity Linc Window ... 2-25

Instrument Startup... 2-25

8086643(2012/09) (03)

iii

BD MAX System User’s Manual

Contents 3 – Controls and Indicators 3.1

General... 3-1

3.2

Power Switch... 3-2

3.3

Door Handle ... 3-2

3.4

All-in-One Computer... 3-3

3.5

External Connections ... 3-6

4 – Operation 4.1

General... 4-1

4.2

User Privileges ... 4-2

4.3

Using the Instrument Interface ... 4-2

4.4

Creating a Full Run... 4-5 4.4.1 4.4.2 4.4.3 4.4.4

4.5

Logging in Samples/Tests... 4-5 Preparing the Instrument... 4-11 The BD MAX Run... 4-13 Interleaved Runs ... 4-17

Viewing, Printing, and Exporting Results... 4-19 4.5.1

4.5.2 4.5.3

Viewing Results... 4-19 4.5.1.1

Run Details ... 4-21

4.5.1.2

PCR Analysis ... 4-23

Printing Results ... 4-24 Downloading (Exporting) Results ... 4-25

4.6

Responding to Errors... 4-26

4.7

End of Day Cleanup ... 4-27

4.8

Long Term Shutdown ... 4-27

5 – Reference 5.1

General... 5-1

5.2

Software Tree ... 5-2

5.3

Main Menu... 5-3

5.4

Logon / Logoff ... 5-5

5.5

Run Displays ... 5-6 5.5.1 5.5.2 5.5.3 5.5.4

iv

Work List Display ... 5-6 PCR Only Display ... 5-10 Pre-warm Display ... 5-11 Test Editor Tab... 5-11

8086643(2012/09) (03)

u Preface

Contents 5.5.5

Consumable Info Display ... 5-11

5.6

Status Display ... 5-14

5.7

Results Display ... 5-18 5.7.1 5.7.2 5.7.3

Reader_A/B Displays... 5-18 Results (List) Display ... 5-19 Run X Display ... 5-22 5.7.3.1

Details ... 5-22

5.7.3.2

PCR Analysis ... 5-25

5.7.3.3

Melt Analysis ... 5-29

5.7.3.4

Quantitative Analysis ... 5-30

5.7.3.5

(Results) Download ... 5-31

5.7.3.6

(Results) Print... 5-34

5.8

Administration ... 5-43

5.9

Maintenance Displays ... 5-43

6 – Maintenance 6.1

General ... 6-1

6.2

Routine Maintenance ... 6-2 6.2.1 6.2.2 6.2.3

6.2.4

End of Day Cleanup... 6-2 Weekly Cleaning ... 6-3 “As Needed” Maintenance ... 6-4 6.2.3.1

System Decontamination ... 6-4

6.2.3.2

Cleaning Spills... 6-5

6.2.3.3

Cleaning the Barcode Scanner Window(s) ... 6-5

Maintenance Menu ... 6-5 6.2.4.1

System Error Summary Display ... 6-6

6.2.4.2

Version Display ... 6-8

6.2.4.3

Maintenance Display ... 6-10

6.2.4.4

Event Log Display ... 6-14

7 – Troubleshooting 7.1

General ... 7-1 7.1.1 7.1.2

Instrument Service ... 7-1 Service Contact Information (USA) ... 7-1

7.2

System Problems ... 7-2

7.3

Error List... 7-5

8086643(2012/09) (03)

v

BD MAX System User’s Manual

Contents A – Limited Warranty B – Ordering Information C – Contact Information Service Contact Information (USA)C-1

D – Glossary and Abbreviations

vi

8086643(2012/09) (03)

u Preface

Figures Figure

Title

Page

Figure 1-1 Figure 1-2 Figure 1-3 Figure 1-4 Figure 1-5 Figure 1-6 Figure 1-7 Figure 1-8

BD MAX Instrument... 1-2 DNA Extraction (typical IVD assay)... 1-4 BD MAX Instrument Interior... 1-6 Main Menu... 1-7 BD MAX System Peripherals... 1-8 DNA URS (typical)... 1-9 Microfluidic Cartridge... 1-10 Symbols Used on the BD MAX Instrument... 1-12

Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 Figure 2-6 Figure 2-7 Figure 2-8

Users Display... 2-7 Date & Time Display... 2-10 Language Display... 2-12 Printer Display... 2-14 Assays Display... 2-16 Select Assay Window... 2-17 Configuration Display... 2-21 External Devices Display... 2-24

Figure 3-1 Figure 3-2 Figure 3-3 Figure 3-4 Figure 3-5

BD MAX Instrument Layout... 3-2 All-in-One – Right Side... 3-4 All-in-One – I/O Ports... 3-4 Monitor and Sound Controls... 3-5 External Connections (I/O Panel)... 3-6

Figure 4-1 Privilege Violation Window... 4-2 Figure 4-2 Display Regions... 4-3 Figure 4-3 Example of Service Mode Indication... 4-4 Figure 4-4 Consumable Info Display... 4-7 Figure 4-5 URS and Reagents in Sample Rack... 4-8 Figure 4-6 Work List Display... 4-10 Figure 4-7 Sample Racks on Instrument Deck... 4-12 Figure 4-8 Inserting a Microfluidic Cartridge... 4-12 Figure 4-9 Status Display with PCR in Progress... 4-14 Figure 4-10 Results List Display... 4-20 Figure 4-11 Details Display... 4-22 Figure 4-12 PCR Analysis Display... 4-23 Figure 4-13 (Results) Print Display... 4-24 Figure 4-14 Results Download Display... 4-25 Figure 5-1 Figure 5-2 Figure 5-3 Figure 5-4 Figure 5-5 Figure 5-6 Figure 5-7 Figure 5-8 Figure 5-9

Main Menu... 5-4 Logon Window... 5-5 Work List Display... 5-9 Consumable Info Display... 5-12 Status Display (blank)... 5-15 Status Display with Catalog Error... 5-16 Status Display with Run Complete... 5-17 Results (List) Display... 5-20 Details Display (left part)... 5-23

8086643(2012/09) (03)

vii

BD MAX System User’s Manual

Figures Figure

Title

Page

Figure 5-10 PCR Analysis Display... 5-26 Figure 5-11 (Results) Download Display... 5-32 Figure 5-12 (Results) Print Display... 5-35 Figure 5-13 Results Report (page 1)... 5-37 Figure 5-14 Results Report (last page)... 5-38 Figure 5-15 Sample PCR Report... 5-40 Figure 6-1 Figure 6-2 Figure 6-3 Figure 6-4 Figure 6-5

viii

System Error Summary Display... 6-7 Version Display... 6-9 Maintenance Display... 6-11 Maintenance Functions Field... 6-12 Event Log Display... 6-15

8086643(2012/09) (03)

Introduction 1.1

Intended Use

The BD MAX System is intended for in vitro diagnostic (IVD) use in performing FDA cleared or approved nucleic acid testing in clinical laboratories. The BD MAX System is capable of automated extraction and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR.

1.2

Overview

The BD MAX System for molecular diagnostics fully automates cell lysis, nucleic acid extraction, PCR set-up, target amplification and detection from a variety of specimen types. Features •

Processes and analyzes up to 24 specimens per run

•

Individual barcode for each BD MAX Sample Buffer tube, scanned by an external barcode reader and verified against the system Work List by an internal barcode reader, ensures traceability throughout extraction and PCR

•

Real-time PCR with two 24-lane microfluidic PCR readers

•

Dedicated multi-color optics: including 475/520, 530/565, 585/630, 630/665, 680/715

•

Performs IVD assays which contain all reagents required for extraction, purification, amplification and detection of a specific target analyte

8086643(2012/09) (03)

1–1

BD MAX System User’s Manual

Figure 1-1 – BD MAX Instrument The BD MAX System contains all hardware and software necessary to drive and monitor operations, as well as calculate, communicate and store results. The system consists of a liquid handling head mounted on a robotic gantry and associated assemblies which allow for nucleic acid extraction and purification from various sample types. The system also performs real-time amplification and detection based on microfluidic technology for the detection of target nucleic acid sequences.

1–2

•

Heater module-provides necessary thermal energy to actuate various microfluidic components on the disposable microfluidic cartridges, and thermal cycling for PCR.

•

Temperature sensors enable real-time monitoring of the heaters through a feedback-based mechanism, allowing for temperature control.

•

Fluorescence Detection-a fluorescence detection system, based on LEDs and photo-diodes with appropriate focusing and filtering components, is incorporated for monitoring fluorescence from the biochemical reactions, capable of multi-color detection.

•

Software-user interface allowing for: •

24 unique thermal cycling channels per system (2 onboard readers)

•

entering patient/sample information, either manually or by external barcode reader

•

monitoring operations, communication and storing of data

•

qualitative, quantitative and melt sample analysis

•

error warnings

•

download of results to a USB thumb drive

•

LIS connectivity

8086643(2012/09) (03)



Introduction

IVD Assay The following overview summarizes the steps, components and theory of operation associated with performance of a complete, target-specific IVD assay on the BD MAX System. •

Specimens are introduced into Sample Buffer tubes according to package insert instructions.

•

Scanned barcode-labeled Sample Buffer tubes are placed into a sample rack.

•

Sample information is entered via the keyboard, or by external barcode reader. Test selection is made using the BD MAX system software.

•

The appropriate number of Unitized Reagent Strips (URS) needed for the run are placed in the sample rack and securely seated. Foil-sealed lyophilized extraction and PCR reagent tubes are snapped into the appropriate positions on each URS.

•

A 24-lane BD MAX Microfluidic Cartridge is placed into a drawer located behind each respective sample rack.

•

Once the run is started, verification of samples, strips, and reagents begins, followed by the extraction and purification process.

•

After extraction, the purified nucleic acid is mixed with master mix, including probes and primers. The instrument then transfers the PCR-ready sample into the sample injection port of the appropriate lane on the BD MAX Microfluidic Cartridge.

•

After all programmed samples are injected, the drawer containing the BD MAX Microfluidic Cartridge is drawn into the reader, where automated PCR amplification and detection are performed.

8086643(2012/09) (03)

1–3

BD MAX System User’s Manual

DNA Extraction Sample lysis and DNA extraction take place in each URS. The steps in the lysis and extraction process are presented schematically in Figure 1-2. The red arrows represent heat that is applied to the Reaction Tube by the heater module. The gray and red box represents a bar magnet that is raised and lowered to come into close proximity to the Reaction Tube of each URS loaded within the sample rack. To start the process, the instrument transfers a fixed volume of the prepared sample to the Extraction Tube to rehydrate the extraction reagents. After rehydration, the mixture is transferred to the Reaction Tube. When applicable, heat is applied to the Reaction Tube and the cells in the sample are lysed, releasing DNA. DNA present in the sample is bound to magnetic beads which have been coated with a proprietary DNA affinity matrix. The magnetic bar is raised to immobilize the DNA bound by the magnetic beads. Supernatant is aspirated from the tube. The magnet is lowered, releasing the magnetic beads. DNA Solution A is added to the tube to remove any non-specifically bound material. The magnet is raised, immobilizing the DNA bound magnetic beads. Supernatant is removed from the tube and the magnet is lowered. DNA Solution B is added to the Reaction tube and the tube is heated to release bound nucleic acids from the magnetic beads. The magnet is raised, immobilizing the beads. The released DNA is transferred from the Extraction Tube to the Conical Tube in the URS, where it is now prepared for PCR analysis. The magnet used in the process is depicted as a red/light gray box labeled NS. Red wavy arrows represent heat being applied to the reaction tube.

Figure 1-2 – DNA Extraction (typical IVD assay)

1–4

8086643(2012/09) (03)



Introduction

1.3

System Overview

The BD MAX System is composed of: •

Instrument

•

Peripherals

•

Reagents

1.3.1 BD MAX Instrument The BD MAX Instrument is capable of: •

Independent nucleic acid extraction and purification

•

PCR amplification using thermal cycling across 24 lanes

•

Real time detection of products of amplification

•

Identification of each Sample Buffer tube by external barcode reader

•

Work List verification by internal barcode reader

•

Fluorescence detection at up to 5 wavelengths, allowing multiplex reactions by Cycle threshold (Ct) call, or multiplex reactions by melt analysis

•

Qualitative, quantitative and melt sample analysis

Figure 1-1 shows a BD MAX instrument (door closed). The BD MAX instrument contains the following modules: a temperature control/heating subsystem to control thermal cycling; a liquid handling head to transfer samples from Sample Buffer tubes to Unitized Reagent Strips; and onboard readers to measure the amplification reaction and report results. Several components are identified in Figure 1-3, and include: Liquid Handling Head The liquid handling head performs all sample transfers. It features a pipettor that is used to transfer fluids. The pipette head consists of 4 nozzles that move as a single unit. Each of the 4 channels can be opened or closed independently. The head also includes sensors to detect when tips have not been successfully picked up or ejected. When at rest, the robotic arm sits at the right rear of the instrument interior. The barcode reader attached to the pipette head is capable of reading linear and 2D barcodes. In a typical run, barcodes are read for the URS, PCR Master Mix tube, Extraction Reagent tube, Sample Buffer tube, and Microfluidic Cartridge. The Master Mix and Extraction disposables are either preconfigured in the URS, or are furnished as snap-in tubes. In addition to the pipettor, barcode reader, and sensors, the liquid handling head contains the x-y-z pipettor drive, pump, valve manifold, pipette interface barrels, and the pipette detection and ejection assembly.

8086643(2012/09) (03)

1–5

BD MAX System User’s Manual

Readers

Liquid Handling Head

^^

Sample Racks

^^

Figure 1-3 – BD MAX Instrument Interior Readers The reader unit consists of 4 major subsystems: the pressure system, the cartridge alignment system, the thermal system and the optical reader system. All the necessary thermal cycling for the run is performed by the on-board thermal system. There are 5 fluorescence channels available on each of the 2 on-board readers.

Wavelength Name

Dye Name

475/520

FAM

530/565

VIC

585/630

Cal Red / ROX

630/665

Cy5

680/715

Cy5.5

Each lane in the PCR amplification cartridge is read during each PCR cycle. Excitation light is directed into the PCR chamber in the cartridge and fluorescent signal is read with a detector.

1–6

8086643(2012/09) (03)



Introduction

Computer and Instrument Software The main computer for the BD MAX System is an All-in-One computer that contains the instrument software. Instrument software is responsible for instrument control, self-calibration, data analysis and storage, and the user interface. The user interface can be navigated with point-and-click icons (keyboard and mouse), or the All-in-One Computer’s touchscreen. Basic displays include: •

Main Menu (Figure 1-4) – When instrument power-up is complete, this display appears. From here, you can access the major functions listed below.

•

Run – The Run module provides displays for defining a Work List (logging in samples) and creating a list of active Consumables.

•

Status – This display shows step-by-step run status information both as messages and as a graphic that updates dynamically, showing run progress.

•

Results – This display allows you to view and manage run results.

•

Administration – This function lets you access displays for managing Users accounts, setting Date and Time, selecting a language for displays and reports, managing printers, importing new Assays, setting up communication with a Laboratory Information System (LIS), and choosing Configuration settings.

•

Maintenance – This module lets you access maintenance functions and view an Error Summary and Event Log.

Figure 1-4 – Main Menu

8086643(2012/09) (03)

1–7

BD MAX System User’s Manual

1.3.2 Peripherals BD MAX System includes the following peripherals: •

Keyboard, mouse, handheld barcode scanner

•

Printer

•

Sample Racks (4)

•

Uninterruptible Power Supply (UPS)

Keyboard, Mouse, and Barcode Scanner The keyboard enables you to type in text information, and the mouse enables you to navigate the displays. A handheld barcode scanner enables you to scan sample tube barcodes, accession barcodes, lot number barcodes, etc., for rapid entry of this type of data. Sample Rack Only the BD MAX sample rack will fit onto the BD MAX instrument deck. Sample racks hold up to 12 Unitized Reagent Strips (URS) and Sample Buffer Tubes. Two racks can be placed on the robot deck in the sample rack station for each run. The racks are comprised of 3 banks, each of which are composed of 4 adjacent strips and Sample Buffer Tube locations. Samples within a bank are processed simultaneously by the 4-channel pipette head that moves as a unit.

Figure 1-5 – BD MAX System Peripherals Typical peripherals are shown. Actual items and quantities may vary from region to region.

1–8

8086643(2012/09) (03)



Introduction

1.3.3 BD MAX IVD Assays •

BD MAX IVD Assay kits contain all the reagents required for analyte detection, including lyophilized BD MAX Extraction Reagent, BD MAX Sample Buffer Tubes, BD MAX Master Mix reagent containing analyte specific probe and primers, and BD MAX Unitized Reagent Strips

•

BD MAX Extraction Reagent provided in each IVD Assay kit contains magnetic beads coated with proprietary DNA affinity matrix and an internal process control. Formulations are designed to optimize DNA extraction based upon sample type. The Extraction Reagent also contains enzymes and reagents necessary for lysis and extraction of DNA based upon sample type and lyophilized beads contained in foil-sealed snap-in tubes.

•

BD MAX Assay-Specific Master Mix contains a complete lyophilized PCR reagent mix for DNA containing assay specific probe and primer along with a probe and primer to amplify and detect an internal process control present in the Extraction Reagent.

•

BD MAX Sample Buffer tubes provided in each IVD Assay Kit is formulated for the sample type being processed.

•

BD MAX DNA Unitized Reagent Strips contain pipette tips, solutions, reaction tube and waste reservoir for deoxyribonucleic acid extraction and purification. The Unitized Reagent Strip (URS) features open positions for addition of extraction and PCR reagents provided in the IVD Assay Kit (Figure 1-6).

•

BD MAX Microfluidic Cartridges incorporate a proprietary microfluidic design that allows for PCR amplification and detection when used in the BD MAX System (Figure 1-7).

NOTE The BD MAX Microfluidic Cartridge can only be used with the BD MAX System.

Figure 1-6 – DNA URS (typical)

8086643(2012/09) (03)

1–9

BD MAX System User’s Manual

Figure 1-7 – Microfluidic Cartridge

1–10

8086643(2012/09) (03)



Introduction

1.4

Manual Structure

This user’s manual contains the following sections:

1.5

•

Section 1 – Introduction – provides an overview of the BD MAX instrument and its uses in the laboratory, its major hardware and software components. An overview of this manual’s structure and conventions is also included.

•

Section 2 – Installation – gives specifications for the BD MAX instrument and instructions for instrument setup.

•

Section 3 – Controls and Indicators – explains the use and meaning of all controls and indicators of the instrument.

•

Section 4 – Operation – provides instructions for routine instrument operation.

•

Section 5 – Reference – provides reference material on the user interface.

•

Section 6 – Maintenance – explains all user instrument maintenance.

•

Section 7 – Troubleshooting – provides a convenient guide identifying error codes and suggesting corrective actions.

•

The Appendices contain a warranty, list of replacement parts, a list of international contacts, and a Glossary.

Use of this Manual

This user’s manual is designed as a reference tool for technologists, supervisors, and other personnel who operate and maintain the BD MAX instrument on a regular basis. Every attempt has been made to include all information which would be required during normal use and maintenance of the instrument. Should a question arise which is not answered in this manual, please contact the following parties (USA): For assistance with mechanical, electrical, or software performance/operation, procedures, or reagents, in North America: 

Technical Services 1–800–638–8663

Other documentation required for proper instrument operation includes: Package Inserts – These documents contain important information on specimen preparation and the use, storage, performance, and limitations of reagents and assay kits. A package insert is included with each IVD assay kit, and is available upon request from BD.

8086643(2012/09) (03)

1–11

BD MAX System User’s Manual

1.6

Conventions

1.6.1 Buttons, Displays, Fields, Messages Screen buttons and icons are always identified by quotation marks, and the words “button” or “icon” (e.g., “Reset errors” button and “Unlock Door” button). Display and Field names are shown in plain text. System messages and prompts are shown within quotes (e.g., “Invalid barcode”). Field names that are variable, such as the CT values that are displayed/printed according to wavelengths, are shown in italics (e.g., CT Wavelength where the actual field name is CT 475/520, CT 530/ 565, etc.). Note that some displays and reports may appear slightly different from the ones shown in this manual. This is due to minor changes in software updates, as well as some configurable options.

1.6.2 Symbols Used on the Equipment The following symbols appear on the BD MAX instrument:

SYMBOL

MEANING



Manufacturer



Catalog Number



In vitro Diagnostic Use



Conformity European



Biohazard



Authorized Representative

Waste Electrical and Electronic Equipment Directive

Figure 1-8 – Symbols Used on the BD MAX Instrument

1–12

8086643(2012/09) (03)