Becton Dickinson

Veritor Plus Analyzer Instructions for Use June 2016

Instructions for Use

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B Veritor Plus Analyzer Instructions for Use/Instructions d'utilisation/ Gebrauchsanleitung/Istruzioni per l'uso/Instrucciones de uso/Bruksanvisning







 Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA



Benex Limited Pottery Road, Dun Laoghaire Co. Dublin, Ireland

Australian Sponsor/Bureau australien/Australischer Sponsor/ Sponsor australiano/Patrocinador australiano/Australiensisk sponsor: Becton Dickinson Pty Ltd. 4 Research Park Drive Macquarie University Research Park North Ryde, NSW 2113 Australia Affix the USB Port Unlock label here.



256066 8091498(03) 2017-06

ATTENTION: To use this Veritor™ Plus Analyzer with Veritor System assays, you must download the most current package inserts and Quick Reference Guides from the BD technical center at: www.bd.com/ds/VeritorSystem

Place USB Port Unlock Label here.

BD Veritor™ Plus Analyzer Instructions for Use

Change History/Historique des modifications/Bisherige Änderungen/Cronologia delle modifiche/Historial de modificaciones/Revisionshistorik Revision/ Révision/ Revision/ Revisione/ Revisión/ Revision

Section Reference/Sections/ Abschnitte/Sezioni/Secciones/ Avsnitten

Reason/Motif/Grund/Motivo/Motivo/Anledning

All/Toutes/Alle/Tutte/Todas/Samtliga

New product/Nourvelle version de produit/Neue Produktversion/Nuova versione di prodotto/Lanzamiento de un producto nuevo/ Ny produktlansering

1. Various/Diverses/Mehrere/ Diverse/Varias/Olika 2. Section/Section/Abschnitt/ Sezione/Sección/Avsnitt 2.6 3. Sections/Sections/Abschnitte/ Sezioni/Secciones/Avsnitten 4.2, 4.4, 4.5, 5.1.1, 6.4 4. Section/Section/Abschnitt/ Sezione/Sección/Avsnitt 4.6 5. Section/Section/Abschnitt/ Sezione/Sección/Avsnitt 7

1.Changed product name from BD Veritor Analyzer to BD Veritor Plus Analyzer./Nom du produit BD Veritor Analyzer remplacé par BD Veritor Plus Analyzer./Produktname von BD Veritor Analyzer zu BD Veritor Plus Analyzer geändert./Nome prodotto BD Veritor Analyzer cambiato in BD Veritor Plus Analyzer./Cambio del nombre de producto de BD Veritor Analyzer a BD Veritor Plus Analyzer./Produktnamnet ändrat från BD Veritor Analyzer till BD Veritor Plus Analyzer. 2. Added verbiage for availability of USB cable for possible test result downloads./Ajout du paragraphe relatif à la disponibilité du câble USB pour les téléchargements de résultats de test./Erklärung zur Verfügbarkeit von USB-Kabel für das mögliche Herunterladen von Testergebnissen hinzugefügt./Aggiunta di informazioni sulla disponibilità di un cavo USB per l'eventuale download dei risultati del test./Adición de una frase sobre la disponibilidad de un cable USB para posibles descargas de resultados de análisis./Lagt till formulering om tillgänglig USB-kabel för nedladdning av testresultat. 3. Changed 10 second reference to 30 seconds test wait times./ Référence aux temps d'attente des tests passée de 10 secondes à 30 secondes./Hinweis von 10 Sekunden zu 30 Sekunden Test-Wartezeit geändert./Riferimento ai tempi di attesa del test modificato da 10 secondi a 30 secondi./Cambio de referencia de 10 segundos a tiempos de espera del análisis de 30 segundos./Ändrat väntetiden på testresultat från 10 till 30 sekunder. 4. Updated workflow configuration procedure./Méthode de configuration du flux opérationnel mise à jour./Verfahren für die Arbeitsablaufkonfiguration geändert./Procedura di configurazione flusso di lavoro aggiornata./Actualización del procedimiento de configuración del flujo de trabajo./Uppdaterat förfarandet för arbetsflödeskonfiguration. 5. Added descriptive table titles. Moved USB unlock label reference to cover page./Ajout des titres de tableaux descriptifs. Déplacement de la référence de l'étiquette de déverrouillage du port USB sur la page de couverture./Beschreibende Tabellentitel hinzugefügt. USB-FreischaltLabel auf Titelseite verschoben./Aggiunta di titoli descrittivi delle tabelle. Riferimento all'etichetta di sblocco USB spostato sulla copertina./Adición de títulos descriptivos a las tablas. Traslado a la portada de la referencia a la etiqueta de desbloqueo de puerto USB./Lagt till beskrivande tabellrubriker. Flyttat informationen om etiketten för USB-upplåsning till förstasidan.

Revision/ Révision/ Revision/ Revisione/ Revisión/ Revision

Section Reference/Sections/ Abschnitte/Sezioni/Secciones/ Avsnitten

Reason/Motif/Grund/Motivo/Motivo/Anledning

Cover, Page ii, Symbol Glossary/ Couverture, Page ii, Glossaire et abréviations/Titelseite, Seite ii, Symbolverzeichnis/Copertina, Pagina ii, Glossario e abbreviazioni/Portada, Página ii, Glosario y abreviaturas/Omslag, Sidan ii, Termer och förkortningar

Cover page barcode updated. Added change history table and RX Only symbol (US only)./Code à barres de la page de couverture mis à jour. Ajout du tableau d'historique des modifications et du symbole Rx Only (États-Unis uniquement)./Barcode auf Titelseite aktualisiert. Protokoll der bisherigen Änderungen und RX Only-Symbol (nur in USA) hinzugefügt./ Codice a barre sulla copertina aggiornato. Aggiunta della tabella delle cronologia delle modifiche e del simbolo RX Only (solo Stati Uniti)./ Actualización del código de barras de la portada. Adición de tabla del historial de modificaciones y del símbolo RX Only (solo para EE. UU.)./ Streckkoden på förstasidan har uppdaterats. Lagt till tabell med ändringshistorik och RX Only-symbol (endast USA).

LIMITED WARRANTY This warranty gives you specific legal rights. Additionally, you may have other rights that vary from region to region. The BD Veritor Plus Analyzer, BD Veritor InfoScan Module, and BD Veritor InfoSync Module are warranted to be free from defects in materials and workmanship for a period of two years following delivery. BD’s sole responsibility under this warranty shall be to repair or replace any instrument or its components (except for expendable supplies) which under normal operating conditions, prove to be defective within two years of delivery. BD will furnish new or re-manufactured components upon its option. All replacements shall meet new part specifications. Replaced components become the property of BD. It is understood that the equipment covered by this warranty has been installed in accordance with the recommendations and instructions in the BD Veritor Plus Analyzer Instructions for Use Manual. Any damage to a BD Veritor Plus Analyzer resulting from the failure of the owner to maintain reasonable care and precautions in the operation and maintenance of the system will void this warranty and terminate the obligations of the manufacturer as stated herein. This warranty is in lieu of all other warranties, whether express or implied, including but not limited to, warranties of merchantability, or fitness for a particular use. In no event will BD Diagnostic Systems be liable for indirect, incidental or consequential damages. BD Veritor and BD are trademarks of Becton, Dickinson and Company. © 2017 BD. BD, and the BD Logo are trademarks of Becton, Dickinson and Company. 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, MD, 21152, USA. GARANTIE LIMITÉE Cette garantie confère à l’utilisateur des droits légaux spécifiques. Elle accorde en outre des droits additionnels qui varient en fonction de la région géographique. Il est garanti à l'acheteur initial que le BD Veritor Plus Analyzer, le module BD Veritor InfoScan et le module BD Veritor InfoSync sont dépourvus de défauts de pièces et main-d'oeuvre pendant une période de deux ans à compter de la livraison. Dans le cadre de cette garantie, BD est responsable uniquement de la réparation ou du remplacement de tout appareil ou composant (à l’exception des consommables) qui, dans des conditions normales d’utilisation, s’est avéré défectueux dans un délai de deux ans à compter de sa livraison. BD se réserve le choix de livrer un composant neuf ou reconditionné. Tous les composants de rechange doivent satisfaire aux spécifications des composants neufs. Les composants remplacés redeviennent la propriété de BD. Il est entendu que l’équipement couvert par la présente garantie a été installé conformément aux recommandations et aux consignes des Instructions d'utilisation du BD Veritor Plus Analyzer. Toute détérioration du BD Veritor Plus Analyzer résultant du manque de soins et de précautions raisonnables par le propriétaire lors de l’utilisation et de la maintenance du système, entraînera l’annulation de cette garantie et mettra fin aux obligations du fabricant telles qu’elles sont définies ici.

iii

Preface

English Contents 1 – Introduction 1.1 Intended Use... 1 1.2 Summary and Explanation... 1 1.3 Principles of the Procedure... 2 1.4 Use of this Manual ... 2 1.5 Conventions ... 2 1.5.1 User Interface ...2 1.5.2 Notes, Cautions, and Warnings ...3 1.5.3 Summary of Cautions and Warnings ...3

2 – Installation 2.1 2.2 2.3 2.4 2.5 2.6

General ... 4 Analyzer Specifications... 4 Analyzer Setup... 5 Printer Setup ... 6 Module Specifications ... 7 Module Setup... 8

3 – Controls and Indicators 3.1 General ...9 3.1.1 Coaxial Power Port ...9 3.1.2 Power Button ...9 3.1.3 System Indicators ...10 3.1.4 Test Device Slot ...11 3.1.5 USB Port ...11

4 – Operation 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8

General ... 11 Using the BD Veritor Plus Analyzer – Analyze Now Operation ... 11 Using the BD Veritor Plus Analyzer – Walk Away Operation ... 13 Kit Quality Control (QC) Test Procedure – Analyze Now Operation... 14 Kit Quality Control (QC) Test Procedure – Walk Away Operation ... 16 Workflow Configuration Procedure ... 18 Workflow Configuration Barcodes... 18 Data Download to a PC ... 19

5 – Maintenance 5.1 General Procedures for Maintenance and Servicing ... 20 5.1.1 BD Veritor System Verification Cartridge ...20 5.1.2 Cleaning...21 5.2 Servicing ...21 5.3 Transportation and Storage ...21

6 – Troubleshooting 6.1 6.2 6.3 6.4

Instrument Service ... 21 Forced Power Down ... 21 Troubleshooting Aids ...21 Result Messages ...23

7 – Configuration Barcodes ...28

BD Veritor™ Plus Analyzer Instructions for Use

Translations/Traductions/Übersetzungen/Traduzioni/Traducciones/Översättningar

Français...31 Deutsch...63 Italiano... 95 Español... 127 Svenska... 159 .

International Contacts/Contacts internationaux/Internationale Ansprechpartner/Centri di assistenza internazionali/Contactos internacionales/Internationella adresser International Contacts...191 Contacts internationaux/internationale Ansprechpartner/Centri di assistenza internazionali/Contactos internacionales/ Internationella adresser

Symbol Glossary/Glossaire des symboles/Symbolverzeichnis/Legenda dei simboli/ Glosario de símbolos/Symbolförklaring Symbol Glossary...193 Glossaire des symboles/Symbolverzeichnis/Legenda dei simboli/Glosario de símbolos/Symbolförklaring

1 – Introduction 1.1

Intended Use The BD Veritor™ Plus Analyzer is for use with BD Veritor System Test Devices.

1.2

Summary and Explanation The BD Veritor Plus Analyzer is a digital immunoassay instrument that is a component of the BD Veritor Plus System. The Analyzer supports the use of different assays by reading an assay-specific barcode on the test device. Depending on the configuration chosen by the operator, the instrument communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility’s information system. A BD Veritor Plus Analyzer can be identified by the image below:

The BD Veritor Plus System features a modular architecture that allows the user to customize the functionality of the system. Those users who wish to expand the functionality of the system can add one of a variety of modules to the system as described below. Please speak to your BD representative about the availability of each module, as all products may not be available in all markets. BD Veritor InfoScan Module – Optional The BD Veritor InfoScan Module is inserted into the BD Veritor Plus Analyzer to add the capability of reading specimen identification, operator identification, reagent lot information, reagent expiration date, enabling workflow mode, and modifying the on-screen display language of the BD Veritor Plus Analyzer. With the BD Veritor InfoScan Module, users can unlock the unit’s data storage to download test information to a connected computer over a USB connection. A BD Veritor Plus Analyzer configured with a BD Veritor InfoScan Module can be identified by the label on its underside, shown in the image below.

BD Veritor™ Plus Analyzer Instructions for Use

BD Veritor InfoSync Module – Optional The BD Veritor InfoSync Module is inserted into the BD Veritor Plus Analyzer to add all of the functionality of the BD Veritor InfoScan Module, plus add secure transmission of test results over a cellular connection to the facility’s information system. A BD Veritor Plus Analyzer configured with a BD Veritor InfoSync Module can be identified by the label on its underside, shown in the image below.

1.3

Principles of the Procedure The BD Veritor Plus Analyzer is an optoelectronic instrument that uses image processing and a specific algorithm to determine the presence or absence of any target analyte(s). The BD Veritor Plus Analyzer detects the insertion of a BD Veritor Test Device and reads the device barcode to detect the assay type. Once it registers the test type, the Analyzer uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip. The Analyzer determines the line intensity at each of the spatially-defined test and control line positions, interprets the results using a scoring algorithm, and reports a positive, negative, or invalid result based on pre-set thresholds. A liquid crystal display (LCD) on the instrument communicates status and results to the operator. Because the BD Veritor Plus Analyzer and Test Devices are designed as an integrated system, it is not possible to replicate the result determination visually. Therefore assay result determination by operator visual readings of the BD Veritor System Test Devices is not recommended. The instrument is maintenance-free and is configured with a single button design (power switch) for ease of operation.

1.4

Use of this Manual This manual is designed as an integral part of instrument operation for technologists, supervisors, and other personnel who operate the BD Veritor Plus Analyzer instrument on a regular basis. Every attempt has been made to include all information that would be required during normal use and maintenance of the system. Should a question arise which is not answered in this manual, please contact the following parties: In North America: Technical Services 1-800-638-8663 International contacts are listed on page 191, or contact your local BD representative. Comments or recommendations on this manual may be expressed via e-mail to [email protected].

1.5

Conventions

1.5.1

User Interface System prompts and messages are shown in CAPITAL LETTERS (e.g., INSERT TEST DEVICE).

1.5.2

Notes, Cautions, and Warnings Throughout this manual, important information is presented in boxes offset from the regular text, and is labeled as either a NOTE, CAUTION, or WARNING. These messages are formatted as shown below and bear the following significance:

NOTE Important information about instrument use worthy of special attention is presented as a NOTE.

CAUTION Information on an activity which could potentially cause damage to the instrument is presented as a CAUTION.

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

1.5.3

Summary of Cautions and Warnings • • • • • • • • • • • •

• • • • •

• •

For in vitro Diagnostic Use. Do not use after expiration date. Dispose of used BD Veritor System Test Devices as biohazardous waste. Dispose of expired BD Veritor Plus Analyzers as biohazardous waste and according to local environmental electronic waste disposal regulation. Do not eat, drink, or smoke in the area where the specimens and kits are handled. Keep the BD Veritor Plus Analyzer, BD Veritor System Test Devices and BD Veritor Verification Cartridge out of reach of children. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are processed. Humidity and temperature can adversely affect results; therefore, operate the BD Veritor Plus Analyzer indoors at room temperature (15–30 °C). Ensure that the BD Veritor Plus Analyzer is not in direct sunlight or exposed to a bright light. The BD Veritor Plus Analyzer is designed for use with BD Veritor System Test Devices. Do not insert any foreign materials into the BD Veritor Plus Analyzer. The BD Veritor Plus Analyzer may contain sensitive patient information and should not be stored in a publicly accessible location. The BD Veritor InfoSync Module utilizes cellular technology to securely transmit data. Cellular service may not be available in all locations and may suffer interruptions in service. The operator of the BD Veritor InfoSync Module is responsible for location of the device such that it receives a cellular signal. Icons on the display window indicate the cellular signal strength. The end user of the BD Veritor InfoSync Module is not the beneficiary of any agreement between BD and its wireless carrier. BD recommends against using patient identifiers that can be readily traced back to a specific patient, such as a patient name or social security number. BD recommends affixing the unlock barcode provided with the BD Veritor Plus Analyzer to this manual and storing the manual in a secure location. Disposable materials and reagents should only be used within their expiration period. BD recommends that expired materials never be used. This equipment complies with radiation exposure limits set forth for an uncontrolled environment. The antenna used in the InfoSync transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be collocated or operated in conjunction with any other antenna or transmitter. The BD Veritor Plus Analyzer contains lithium coin cell and lithium-ion cell batteries. Do not incinerate. Dispose of or recycle in accordance with national and local requirements. AC ADAPTER WARNING: RISK OF FIRE! SHOCK HAZARD!: To prevent electric shock, do not remove the cover. No user-serviceable parts inside. This unit contains hazardous voltages and should only be opened by a trained and qualified technician. Do not use if bent, cracked, modified or compromised.

BD Veritor™ Plus Analyzer Instructions for Use

Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens.

 Standard Precautions and institutional guidelines for the handling of biohazardous materials should be followed in handling all items contaminated with blood and other body fluids. Protection provided by this equipment may be impaired if the equipment is used in a manner not consistent with the instructions in

 this manual.

2 – Installation 2.1

General This section provides specifications for installation and setup of the BD Veritor Plus Analyzer, plus the optional BD Veritor InfoScan Module and BD Veritor InfoSync Module. The following major topics are included: • • • • •

Analyzer Specifications Analyzer Setup Printer Setup Module Specifications Module Setup

WARNING PROTECTION PROVIDED BY THIS EQUIPMENT MAY BE IMPAIRED IF THE EQUIPMENT IS USED IN A MANNER NOT CONSISTENT WITH THE INSTRUCTIONS IN THIS MANUAL.

2.2

Analyzer Specifications

Physical Specifications Length

14.3 cm

Width

9.0 cm

Height (including feet)

7.6 cm

Weight (Analyzer)

300 g

Weight (Analyzer and installed module)

350 g

Electrical Specifications

Supply Voltage

The BD Veritor Plus Analyzer is provided with an auto-switching power supply with recommended input of 100–240 VAC at 50–60 Hz, 0.6 A. The Analyzer power requirement is 5.0 VDC ± 5%, 1500 mA.

Environmental Specifications Operating Conditions Ambient Temperature

15.0–30.0 °C (59–86 °F)

Ambient Humidity

Up to 85% RH, non-condensing

Ambient Light

0–3000 lux uniform illumination

Ambient Environment

Indoor Use Only

Other Installation Category

II (per IEC 664)

Pollution Degree

2 (per IEC 664)

Other Specifications

2.3

Display Languages (BD Veritor InfoScan or InfoSync module required for configuration)

English, French, German, Italian, Spanish, Swedish

Lifetime Number of Tests Performed

3500 maximum

Lifetime Number of Months from Date of First Use

24 months

Lifetime Maximum Shelf-Life from Date of Manufacture (regardless of use)

34 months

Operation Modes

Analyze Now mode Walk Away mode

Analyzer Setup Box contents • • • • •

1 BD Veritor Plus Analyzer 1 Instructions for Use Manual 1 USB Port Unlock Barcode adhesive label (place label in a safe place) 1 compact AC power adapter with blade adapters for USA, Japan, United Kingdom & European Union 1 BD Veritor Verification Cartridge NOTE If any items are missing, contact your BD representative. (See page 191 for contact information.)

BD Veritor™ Plus Analyzer Instructions for Use

Analyzer Unpacking and Setup 1

Before using the BD Veritor Plus Analyzer, visually inspect the contents for damage. If damage is apparent, contact your BD Representative or BD Technical Services.

The BD Veritor Plus Analyzer ships with an adhesive-backed USB Port Unlock Barcode label, which is used on Analyzers that are configured with a BD Veritor InfoScan Module or BD Veritor InfoSync Module. BD recommends affixing this label to the space indicated on the cover page of this manual or kept in a secure location of your choice for future use. Instructions for using the USB Unlock Barcode can be found in section 4.6. These optional modules may not be available in all regions; please contact your local BD representative for availability.

Remove the Analyzer and power adapter from the protective wrapping. BD recommends retaining the packing materials in a safe location.

Refer to the figure below. Select the blade adapter that is appropriate for the local region. Blades included are: • North America / Japan NEMA 1-15P • United Kingdom BS 1363 • European CEE 7/16

2.4

Slide the retaining clip (1) down on the power adapter.

Insert the notched end (2) of the blade adapter into the top of the power adapter at a 30–60 degree angle.

Push the bottom (3) of the blade adapter into the power adapter.

Slide the retaining clip (1) up to lock the blade adapter in place.

Insert the coaxial power connector into the round port on the back of the Analyzer, and insert the power adapter plug into an electrical outlet.

Perform a verification test as described in section 5.1.1, BD Veritor System Verification Cartridge.

Printer Setup – Optional Printer Unpacking and Setup The BD Veritor Plus Analyzer can be configured to print test results to a connected printer. The printed language will match the currently configured display language. The BD Veritor Plus Analyzer supports only specific printer models. Contact your BD representative to obtain a list of compatible printer models and operating instructions. A USB 2.0 On-The-Go micro-A to B cable, or USB On-The-Go adapter, is required. The cable may be purchased from computer supply retailers or may be ordered from BD under catalog number 443907. For unpacking and setup instructions, or information about ordering replacement paper, refer to the instructions provided with the printer. The printer is connected to the BD Veritor Plus Analyzer as follows:

Connect the USB B end of the USB cable to the corresponding port on the back of the printer.

Connect the USB micro-A end of the USB cable to the corresponding rectangular port on the back of the BD Veritor Plus Analyzer.

NOTE The BD Veritor Plus Analyzer will only print test results when the printer is connected and powered on during the test procedure. Due to data security considerations, test results cannot be recalled for subsequent printing. Prior to initiating testing, ensure that the printer paper supply is adequate to support the test volume.

2.5

Module Specifications – Optional Catalog Numbers BD Veritor InfoScan Module

256068

BD Veritor InfoSync Module

256067

Environmental Specifications Operating Conditions Ambient Temperature

15.0–30.0 °C (59–86 °F)

Ambient Humidity

Up to 85% RH, non-condensing

Ambient Light

0–3000 lux, uniform illumination

Ambient Environment

Indoor Use Only

Other Installation Category

II (per IEC 664)

Pollution Degree

2 (per IEC 664) The BD Veritor InfoScan Module does not expire.

Lifetime Specification

The BD Veritor InfoSync Module does not expire; however, its data subscription features a specific lifetime. The provision of the connectivity service that is included with the BD Veritor InfoSync Module is dictated by the terms of a facility’s service agreement with BD.

Performance Specifications Compatible 1D Barcode Protocols

Code 128, Code 39, UPC / EAN, Interleaved 2 of 5, Codabar, GS1 DataBar, GS1-128. ASCII-128 character set.

Operator ID Maximum Barcode Length

20 characters (Longer barcodes are truncated to 20 characters)

Specimen ID Maximum Barcode Length

20 characters (Longer barcodes are truncated to 20 characters)

BD Veritor™ Plus Analyzer Instructions for Use

Cellular Technology (BD Veritor InfoSync Module only)

Five band 3G HSPA

Data Transmission Security Protocols

HTTPS with SSL/TLS certification. AES-256 payload encryption.

Default Workflow Configuration

2.6

Operator Identification Scan

Disabled

Specimen Identification Scan

Enabled

Kit Lot Information Scan

Disabled

Display Language

English

USB Port

Locked

Module Setup – Optional The BD Veritor InfoScan package includes a USB cable which may be used to download test results to a computer. A BD Veritor Plus Analyzer can accommodate either one BD Veritor InfoScan Module or one BD Veritor InfoSync Module. The steps for installing the module are the same for both: 1

Turn the Analyzer power off.

Turn the Analyzer upside down.

CAUTION Ensure that the power button is not accidentally pressed while the Analyzer is upside-down. Power to the Analyzer should remain off during module installation.

Depress the locking tab on the module bay cover.

WARNING ELECTRICAL EXPOSURE HAZARD. DO NOT TOUCH THE ELECTRICAL CONTACTS INSIDE THE MODULE BAY.

Slide the module bay cover off of the Analyzer. The module bay cover should be stored in a secure location.

Align the module alignment features to the Analyzer track.

Slide the module into the Analyzer until an audible click is heard.

The Analyzer is now ready for operation. See 4.6 Workflow Configuration Procedure – Optional for optional configuration instructions.

NOTE Steps 1–7 above complete the physical installation of the BD Veritor InfoSync Module, but as the InfoSync Module is used to transmit assay results to a BD-hosted cloud server and then to a facility’s information system, additional IT setup is required. To create or troubleshoot this connection, please contact your local BD representative.

3 – Controls and Indicators 3.1

General This section describes the meaning and use of the controls and indicators of the BD Veritor Plus Analyzer. Some components are illustrated in the figures accompanying the related text. The following controls and indicators are discussed: • • • • •

Coaxial Power Port Power Button System Indicators Test Device Slot USB Port

WARNING ALL USERS SHOULD BECOME THOROUGHLY FAMILIAR WITH ALL CONTROLS AND INDICATORS BEFORE ATTEMPTING TO OPERATE THE INSTRUMENT

3.1.1

Coaxial Power Port The BD Veritor Plus Analyzer features a rechargeable lithium-ion battery for portable usage and includes an AC power adapter to recharge the battery or to directly power the unit from a facility power supply. To charge the BD Veritor Plus Analyzer, plug the cylindrical end of the charger into the corresponding port on the back of the Analyzer and plug the power adapter into the facility power source. The BD Veritor Plus Analyzer can be externally powered only from the coaxial power port on the rear of the instrument. The Analyzer cannot be powered through its USB port. When the BD Veritor Plus Analyzer is properly connected to the facility power supply and powered on, the Plug icon will appear on the screen as shown below in section 3.1.3.

3.1.2

Power Button To power on the Analyzer, depress the power button. After doing so, the BD Veritor Plus Analyzer screen will display the BD Logo, then enter a self-test mode. After the self-test is completed successfully, the Analyzer is ready to test and will prompt the user to insert a test device. BD Veritor Plus Analyzers that have optional modules installed may prompt the user for additional workflow steps during the power-on process. For instructions relating to these steps, see section 4. To power off the Analyzer, depress the power button for at least half a second and release. If the Analyzer is left unattended for 15 minutes (when operating on the internal battery), or 60 minutes (when operating on the external power adapter), the Analyzer will automatically shut off and the test result will not be retained on the screen.

BD Veritor™ Plus Analyzer Instructions for Use

3.1.3

System Indicators The meanings of on-screen displays used on the BD Veritor Plus Analyzer are as follows:

Symbol

Meaning Hourglass: An indication that the Analyzer and/or the BD Veritor InfoSync Module subscription are nearing end of life, either due to usage duration (time) or usage count. In addition to the Hourglass icon, a descriptive message will appear on the screen after the power-on self-test is complete. The message describes which end-of-life event is approaching and the remaining usage time or usage count available. Each end-of-life event generates a unique screen message; insertion of a test device terminates all messages and immediately initiates a test. When this symbol is present, the user should contact their BD representative to order a new BD Veritor Plus Analyzer or renew the BD Veritor InfoSync Module subscription. The symbol switches from a continuous state to flashing when end of life is imminent. See section 2.2 - Analyzer Specifications for an explanation of lifetime specifications.

Plug: When the Analyzer is properly connected to the facility power supply and powered on, the Plug icon will appear on screen. If the Plug icon is flashing, it indicates a failure in the battery charging circuit. Contact BD for assistance. The Analyzer may continue to be used when connected to the facility power supply. Battery: An indication of battery strength. The maximum battery strength is represented by four bars. When the battery is nearly discharged, no bars are displayed and the battery outline flashes, indicating an imminent need for recharge. While the battery is charging, the bars will cycle to indicate charging is underway. Once the battery is fully charged, the cycling will stop and four bars will appear in a continuous state. This symbol only appears on BD Veritor Plus Analyzers that are equipped with the BD Veritor InfoSync Module. Signal: A representation of the cellular signal strength available to the Analyzer. The maximum strength is represented by five bars. The antenna symbol flashes when searching for a cellular network. This symbol only appears on BD Veritor Plus Analyzers that are equipped with the BD Veritor InfoSync Module. Envelope: An indication that data are either awaiting transmission or are in the process of being transmitted over the cellular network to the BD Cloud Connectivity Solution service.

3.1.4

Test Device Slot The test device slot is located on the right side of the BD Veritor Plus Analyzer (see arrow in figure below). Test devices are inserted by aligning the insertion arrow on the device with the insertion arrow on the Analyzer. A distinctive “click” will be noted when the test device is properly engaged in the Analyzer.

3.1.5

USB Port The BD Veritor Plus Analyzer includes a USB On-The-Go port which is used for three applications: •

• •

Analyzer Update: the BD Veritor Plus Analyzer can be updated, using a USB flash drive that is provided by BD, to add capability to read additional BD Veritor assays and to add new features. Instructions to perform these updates are provided with the USB flash drive when such updates are available. Printing: The optional printer is connected to the BD Veritor Plus Analyzers via this port. See section 2.4 for instructions. Data Download: BD Veritor Plus Analyzers that are equipped with either a BD Veritor InfoScan Module or BD Veritor InfoSync Module can be unlocked to enable secure transfer of the test record to a computer via this port. See section 4.8 – Data Download, for instructions.

NOTE The BD Veritor Plus Analyzer can be externally powered only from the coaxial power port on the rear of the instrument. The Analyzer cannot be powered through its USB port.

4 – Operation 4.1

General Section 4.2 provides instructions for routine operation of the BD Veritor Plus Analyzer using the Analyze Now operational mode. In this mode, the test device is prepared and developed outside of the Analyzer, then inserted to perform the final read. Section 4.3 provides instructions for routine operation of the BD Veritor Plus Analyzer using the Walk Away operational mode. In this mode, the test device is prepared outside the Analyzer but allowed to develop inside the Analyzer. The Analyzer initiates the final read at the appropriate time. Both sections include instructions for operation with or without the BD Veritor InfoScan or InfoSync module installed. Sections 4.4 and 4.5 describe the Quality Control (QC) test procedure in Analyze Now and Walk Away mode, respectively.

4.2

Using the BD Veritor Plus Analyzer – Analyze Now Operation The BD Veritor Plus Analyzer is intended for use with BD Veritor Test Devices. Specific instructions for performing a BD Veritor Test can be found in the package insert included with each test kit. After following those instructions the procedure for interpreting a test result with the BD Veritor Plus Analyzer using Analyze Now operation is as follows: 1

Place the BD Veritor Plus Analyzer on a flat, dry, stable surface.

Ensure that the BD Veritor Plus Analyzer is not in direct sunlight or exposed to a bright light.

Check the BD Veritor Plus Analyzer for an inserted device. If a device is present, remove it from the Analyzer.

BD Veritor™ Plus Analyzer Instructions for Use

Press the front panel power button. The BD Veritor Plus Analyzer will complete a self-test before it is ready for use. After the self-test completes and any temporary messages are presented, the display window shows INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE. If an InfoScan or InfoSync module is installed: The display window shows SCAN CONFIG BARCODE for 2 seconds after the self-test. This is an optional step, no action is required. To perform instrument configuration, refer to section 4.6 – Workflow Configuration for configuration instructions.

When the display window shows INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE, insert the fully developed BD Veritor Test Device into the slot on the right side of the Analyzer, aligning the insertion arrow on the test device with the arrow above the slot. Insert the device fully until it stops. A distinctive “click” will be noted when the device is properly aligned in the Analyzer. If an InfoScan or InfoSync module is installed: a.

If the BD Veritor Plus Analyzer has been configured with barcode ID–Enable Operator ID, it will display SCAN OPERATOR ID. When this message is displayed, after verifying that the Operator ID to be scanned is correct, the operator should scan his/her identification barcode. This message is displayed for up to 30 seconds, after which the BD Veritor Test Device must be removed and the read process restarted with step 5. After a specific Operator Identification has been recorded, that Operator Identification will be utilized for all subsequent tests until the BD Veritor Plus Analyzer is powered off. On the next power cycle, the SCAN OPERATOR ID prompt will be repeated during the first test. A test result cannot be generated if the Operator ID is not input when the Operator ID workflow option is enabled. BD recommends reading Operator Identification barcodes with the Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window.

If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Specimen ID, it will display SCAN SPECIMEN ID. When this message is displayed, after verifying that the Specimen ID is correct, the operator should scan the specimen’s identification barcode. This message is displayed for up to 30 seconds, after which the BD Veritor Test Device must be removed and the read process restarted with step 5. The Specimen ID scan prompt is repeated for every test. A test result cannot be generated if the Specimen ID is not input when the Specimen ID workflow option is enabled. BD recommends reading Specimen Identification barcodes with the Analyzer positioned at the edge of a flat surface. The barcode should then be moved towards the barcode window to be scanned. The scanned barcode value will be shown in the next display window.

If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Kit Lot Information, it will display SCAN KIT LOT NUMBER. When this message is displayed, the operator should scan the barcode on the exterior of the BD Veritor Test Kit box. This message is displayed for up to 30 seconds, after which the BD Veritor Test Device must be removed and the read process restarted with step 5. The Kit Lot Number scan prompt is repeated for every test. A test result cannot be generated if the Kit Lot Number is not input when the Kit Information workflow option is enabled. If the BD Veritor Test Kit box label has two barcodes, scan only the upper barcode which starts with (17). BD recommends reading the Kit Information barcode with the Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window.

After insertion of the test device, the BD Veritor Plus Analyzer will progress through two processing steps: a reading step, followed by an analyzing step. The display will show the remaining time for each step as they are performed. Do not touch the Analyzer or remove the test device during this time.

When the analysis is complete, the test result will be displayed with the name of the test and a result. Refer to the package insert for the BD Veritor Test Device for specific result interpretations. If a printer is connected to the unit and powered on, the test result will automatically be sent to the printer. If an InfoScan or InfoSync module is installed: If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Specimen ID, the specimen identification is also displayed on the screen.

Verify that the test type and specimen identification (if appropriate) are correct.

If an InfoSync module is installed: The ENVELOPE symbol will appear to indicate that results are being transmitted over the secure cellular connection. The symbol will disappear after the results have been transmitted. In the event that the BD Veritor Plus Analyzer does not detect adequate cellular network strength, it will queue all results to be transmitted and continuously attempt to transmit the results while it is powered on. If the Analyzer is powered off while the ENVELOPE symbol is still present, the Analyzer will queue the result and transmit it the next time that it is powered up. 10

4.3

To initiate a new test, repeat steps 5–9 above, or turn off the power by depressing the front panel power button for at least half a second and releasing it. If the Analyzer is left unattended for 15 minutes (when operating on the internal battery), or 60 minutes (when operating on the external power adapter), the BD Veritor Plus Analyzer will automatically shut off and the test result will not be retained on the screen.

Using the BD Veritor Plus Analyzer – Walk Away Operation

NOTE The AC power adapter must be connected to the Analyzer and plugged into a facility power source to use Walk Away operation.

NOTE If the Analyzer is left unattended for 60 minutes after completion of the test run, the power will automatically shut off and the test result will not be retained on the screen. The BD Veritor Plus Analyzer is intended for use with BD Veritor Test Devices. Specific instructions for performing a BD Veritor Test can be found in the package insert included with each test kit. After following those instructions up to sample preparation in the reagent tube, the procedure for interpreting a test result with the BD Veritor Plus Analyzer using Walk Away operation is as follows. DO NOT DISPENSE THE SPECIMEN INTO THE TEST DEVICE SAMPLE WELL AT THIS TIME. 1

Place the BD Veritor Plus Analyzer on a flat, dry, stable surface.

Ensure that the BD Veritor Plus Analyzer is not in direct sunlight or exposed to a bright light.

Ensure that the AC power adapter is connected to the Analyzer and plugged into a facility power source.

Check the BD Veritor Plus Analyzer for an inserted device. If a device is present, remove it from the Analyzer.

When the display window shows INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE, double-click the power button. If an InfoScan or InfoSync module is installed: a. If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Operator ID, it will display SCAN OPERATOR ID. When this message is displayed, after verifying that the Operator ID to be scanned is correct, the operator should scan his/her identification barcode. This message is displayed for up to 30 seconds, after which the process will restart with step 6. After a specific Operator Identification has been recorded, that Operator Identification will be utilized for all subsequent tests until the BD Veritor Plus Analyzer is powered off. On the next power cycle, the SCAN OPERATOR ID prompt will be repeated during the first test. A test result cannot be generated if the Operator ID is not input when the Operator ID workflow option is enabled. BD recommends reading Operator Identification barcodes with the Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window. b. If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Specimen ID, it will display SCAN SPECIMEN ID. When this message is displayed, after verifying that the Specimen ID is correct, the operator should scan the specimen’s identification barcode. This message is displayed for up to 30 seconds, after which the process will restart with step 6. The

BD Veritor™ Plus Analyzer Instructions for Use

Specimen ID scan prompt is repeated for every test. A test result cannot be generated if the Specimen ID is not input when the Specimen ID workflow option is enabled. BD recommends reading Specimen Identification barcodes with the Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window. c. If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Kit Lot Information, it will display SCAN KIT LOT NUMBER. When this message is displayed, the operator should scan the barcode on the exterior of the BD Veritor Test Kit box. This message is displayed for up to 30 seconds, after which the process restarts with step 6. The Kit Lot Number scan prompt is repeated for every test. A test result cannot be generated if the Kit Lot Number is not input when the Kit Information workflow option is enabled. If the BD Veritor Test Kit box label has two barcodes, scan only the upper barcode which starts with (17). BD recommends reading the Kit Information barcode with the Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window. 7

The display window will now show ADD SPECIMEN TO TEST DEVICE AND INSERT IMMEDIATELY. This message is displayed for up to 3 minutes, after which the process restarts with step 6. Apply the prepared specimen to the test device sample well as instructed in the test device kit package insert and immediately insert the test device into the slot on the right side of the Analyzer, aligning the insertion arrow on the test device with the arrow above the slot. Insert the device fully until it stops. A distinctive “click” will be noted when the device is properly aligned in the Analyzer. During this process the test device must remain horizontal to prevent spilling the specimen out of the sample well.

The display window will now show DO NOT DISTURB TEST IN PROGRESS. The incubation time is determined based on the test device barcode. The incubation time remaining is shown on the display. Do not disturb the test device or Analyzer during the incubation period. Do not remove the test device; doing so will cause the test to abort.

After the incubation is complete, the BD Veritor Plus Analyzer will progress through two processing steps: a reading step, followed by an analyzing step. The display will show the remaining time for each step as they are performed. Do not touch the Analyzer or remove the test device during this time.

When the analysis is complete, the test result will be displayed with the name of the test and a result. Refer to the package insert for the BD Veritor Test Device for specific result interpretations. If a printer is connected to the unit and powered on, the test result will automatically be sent to the printer. If an InfoScan or InfoSync module is installed: If the BD Veritor Plus Analyzer has been configured with barcode ID–Enable Specimen ID, the specimen identification is also displayed on-screen.

Verify that the test type and specimen identification (if appropriate) are correct.

Once the test type and specimen identification, if appropriate, is verified and the result noted, remove the test device by pulling it out. The display will show INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE to indicate the Analyzer is ready to perform another test. If an InfoSync module is installed: The ENVELOPE symbol will appear to indicate that results are being transmitted over the secure cellular connection. The symbol will disappear after the results have been transmitted. In the event that the BD Veritor Plus Analyzer does not detect adequate cellular network strength, it will queue all results to be transmitted and continuously attempt to transmit the results while it is powered on. If the Analyzer is powered off while the ENVELOPE symbol is still present, the Analyzer will queue the result and transmit it the next time that it is powered up.

4.4

To initiate a new test, repeat steps 6–12 above, or turn off the power by depressing the front panel power button for at least half a second and releasing it. If the Analyzer is left unattended for 60 minutes, the BD Veritor Plus Analyzer will automatically shut off and the test result will not be retained on the screen.

Kit Quality Control (QC) Test Procedure – Analyze Now Operation NOTE To utilize the Analyzer’s QC Test documentation feature, the Analyzer must be equipped with either a BD Veritor InfoScan Module or a BD Veritor InfoSync Module, and must have been configured with barcode – Enable Specimen ID.

NOTE The Analyzer records the Kit Lot and Control Swab expiration dates in the test record but does not restrict the use of expired reagents. Management of expired materials is the responsibility of the user per local site regulations or practices. BD recommends that expired materials never be used.

The BD Veritor Plus Analyzer is intended for use with BD Veritor Test Devices. Specific instructions for performing a BD Veritor Quality Control (QC) Test can be found in the package insert included with each test kit. After following those instructions the procedure for interpreting a test result with the BD Veritor Plus Analyzer using Analyze Now operation is as follows: 1

Place the BD Veritor Plus Analyzer on a flat, dry, stable surface.

Ensure that the BD Veritor Plus Analyzer is not in direct sunlight or exposed to a bright light.

Check the BD Veritor Plus Analyzer for an inserted device. If a device is present, remove it from the Analyzer.

Press the front panel power button. The BD Veritor Plus Analyzer will complete a self-test before it is ready for use. After the self-test completes, the display window shows SCAN CONFIG BARCODE. This is an optional step, no action is required. After 2 seconds, the display window shows INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE. To perform instrument configuration, refer to section 4.6–Workflow Configuration for configuration instructions.

When the display window shows INSERT TEST DEVICE OR DOUBLE-CLICK BUTTON FOR WALK AWAY MODE, insert the fully developed BD Veritor Test Device which has been prepared with an external control into the slot on the right side of the Analyzer, aligning the insertion arrow on the test device with the arrow above the slot. Insert the device fully until it stops. A distinctive “click” will be noted when the device is properly aligned in the Analyzer.

If the BD Veritor Plus Analyzer has been configured with barcode ID – Enable Operator ID, it will display SCAN OPERATOR ID. When this message is displayed, after verifying that the Operator ID to be scanned is correct, the operator should scan his/her identification barcode. This message is displayed for up to 30 seconds, after which the BD Veritor Test Device must be removed and the read process restarted with step 5. After a specific Operator Identification has been recorded, that Operator Identification will be utilized for all subsequent tests until the BD Veritor Plus Analyzer is powered off. On the next power cycle, the SCAN OPERATOR ID prompt will be repeated during the first test. A test result cannot be generated if the Operator ID is not input when the Operator ID workflow option is enabled. BD recommends reading Operator Identification barcodes with the BD Veritor Plus Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window.

In the case of Quality Control (QC) Tests, the barcode on the printed label of the swab control supplied with the kit is used as the Specimen ID. The display window will now display SCAN SPECIMEN ID. When this message is displayed, the operator should scan the barcode on the printed label on the swab control supplied with the kit. This message is displayed for up to 30 seconds, after which the BD Veritor Test Device must be removed and the read process restarted with step 5. A test result cannot be generated if the swab control barcode is not input. BD recommends reading Quality Control (QC) barcodes with the Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window.

In the case of Quality Control (QC) Tests, the barcode on the printed label of the test device kit box must be scanned. The display window will show SCAN KIT LOT NUMBER whether the kit information workflow configuration setting is enabled or disabled for normal operation. When this message is displayed, the operator should scan the barcode on the exterior of the BD Veritor Test Kit box. This message is displayed for up to 30 seconds, after which the Test Device must be removed and the read process restarted with step 5. A test result cannot be generated if the Kit Lot Number is not input. If the BD Veritor Test Kit box label has two barcodes, scan only the upper barcode which starts with (17). BD recommends reading Kit Lot Information barcodes with the BD Veritor Plus Analyzer positioned at the edge of a flat surface. The barcode should then be moved toward the barcode window to be scanned. The scanned barcode value will be shown in the next display window.

After all required scans are complete, the BD Veritor Plus Analyzer will progress through two processing steps: a reading step, followed by an analyzing step. The display will show the remaining time for each step as they are performed. Do not touch the Analyzer or remove the test device during this time.

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