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23-19777-03 (02 2023) FACSDuet - Site Preparation Guide
23-19777-03 (02 2023) FACSDuet - Site Preparation Guide
23-19777-03 (02 2023) FACSDuet - Site Preparation Guide
23-19777(03)
2023-02
Copyrights
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 prior
written permission from BD.
The information in this guide is subject to change without notice. BD reserves the right to change its products and services at any time.
Although this guide has been prepared with every precaution to ensure accuracy, BD assumes no liability for any errors or omissions, nor for
any damages resulting from the application or use of this information. BD welcomes customer input on corrections and suggestions for
improvement.
Trademarks
BD, the BD Logo, BD Assurity Linc, BD FACSDuet, BD FACSLink, BD FACSLyric and BD FACSuite are trademarks of Becton, Dickinson and
Company or its affiliates. All other trademarks are the property of their respective owners. © 2023 BD. All rights reserved.
Regulatory information
For In Vitro Diagnostic Use.
FCC information
WARNING: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s
authority to operate the equipment.
NOTICE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC
Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his or her own
expense. Shielded cables must be used with this unit to ensure compliance with the Class A FCC limits. This Class A digital apparatus meets
all requirements of the Canadian Interference-Causing Equipment Regulations. Cet appareil numérique de la classe A respecte toutes les
exigences du Réglement sur le matériel brouilleur du Canada.
NOTE: “Harmful interference” is defined in 47 CFR § 2.1 by the FCC as follows: Interference which endangers the functioning of a radio-
navigation service or of other safety services or seriously degrades, obstructs, or repeatedly interrupts a radio communication service
operating in accordance with the International Telecommunication Union (ITU) Radio Regulations.
EC information
The BD FACSDuet™ Sample Preparation System is for in vitro diagnostic use. The system is CE marked in compliance with Regulation (EU)
2017/746 and Directive 2006/42/EC.
Electromagnetic compliance
The BD FACSDuet™ Sample Preparation System complies with standard EN 61326-2-6:2013, Section 9.3 (emission and immunity
requirements). This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio
interference, in which case, you may need to take measures to mitigate the interference. The electromagnetic environment should be
evaluated prior to operating the device. Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.,
unshielded intentional radio frequency sources), as these can interfere with the proper operation.
History
23-19777-01 2020-09 Updated with instrument crate dimensions, instrument table dimensions,
instrument and software requirements, and minor corrections and
organizational improvements.
23-19777(03) 2023-02 Updated with information about the BD FACSDuet™ Premium instrument
and upgrade kit.
Contents
1. Introduction 7
About this guide 8
Base and Premium instrument with crate and box dimensions and weight 8
Premium upgrade kit box dimensions and weight 9
Equipment moving and installation policy 9
2. Site requirements 11
Instrument and software requirements 12
Space and clearance requirements 12
Structural, environmental, and power requirements 14
3. Checklist 17
6 BD FACSDuet™ Sample Preparation System Site Preparation Guide
1
Introduction
This chapter covers the following topics:
The BD FACSDuet™ system is available as a Base instrument or a Premium instrument. A Premium upgrade kit
is available for users who want to upgrade a Base instrument. Except where otherwise indicated, the
information in this guide applies to both the Base instrument and the Premium instrument.
Additional information
See the BD FACSDuet™ Sample Preparation System Safety and Limitations Guide for more information on
system safety and hazards.
Premium:
262 kg (577.6 lb)
Premium:
51 kg (112.4 lb)
The Premium upgrade kit includes the wash carousel, centrifuge, bulk fluid drawer, two sets of bulk fluid tanks,
an extra waste tank, and liquid supply panel.
The following table shows the dimensions and weight of the Premium upgrade kit pallet and box.
Contact information
To contact your representative, go to bdbiosciences.com and click Contact Us.
10 BD FACSDuet™ Sample Preparation System Site Preparation Guide
2
Site requirements
This chapter covers the following topics:
The BD FACSDuet™ instrument requires one or more BD FACSLyric™ instruments. If you will be using
BD FACSLyric™ instruments that you already have in your lab, ensure that you are using version 1.4 or later of
BD FACSuite™ Clinical application and BD FACSuite™ application.
A gravimetric scale (calibrated pan balance) is required in the lab with the BD FACSDuet™ system. The balance
needs to have a resolution of .0001 grams. We recommend a 60 g analytical balance. Ensure that it is
calibrated on a yearly basis.
The following table provides workspace dimensions for the BD FACSDuet™ system alone and the BD
FACSDuet™ system with a physically integrated BD FACSLyric™ system.
Premium
64.4
(25.4 in.)
Premium
80.9
(31.9 in.)
For proper ventilation, ensure that there is at least 5 cm (2 in.) of space between the back of the instrument and
the wall. If you use the optional extended-use sheath and waste containers with the BD FACSLyric™ system, you
will need additional floor space.
The following illustrations show the BD FACSDuet™ Base instrument. The BD FACSDuet™ Premium instrument
has an extra waste tank that adds 16.1 cm (6.3 in.) of additional width to the floor space needed for the tanks.
14 BD FACSDuet™ Sample Preparation System Site Preparation Guide
Structure
The BD FACSDuet™ instrument will fit through doorways and hallways that are at least 88.9 cm (35 in.) wide.
The BD FACSDuet™ system does not require external air, water, or vacuum lines. We highly recommend the
presence of a sink inside the laboratory.
Location
For optimum performance of the BD FACSDuet™ system, avoid placing it near:
Environment
The following table shows the environmental conditions necessary for the BD FACSDuet™ system to operate
optimally.
Condition Requirement
Temperature The BD FACSDuet™ system has an operating range between 15 °C (59 °F) and 30 °C (86 °F). We
recommend that the lab temperature fluctuate less than 5 °C within a day for best operation.
Humidity The operating humidity tolerance is between 20% and 80% relative humidity (noncondensing).
Lighting
The BD FACSDuet™ system is shielded from room lighting and has no specific requirements.
Chapter 2. Site requirements 15
Communications
We recommend that you have the following communication tools:
• A telephone in proximity to the instrument to communicate with BD and the BD Customer Support Center
regarding system operation and function
• A network connection of at least 100 Mbps to use BD FACSLink™ software
• Access to an internet connection through your local intranet and firewall to check the BD website for
updates.
Power
The FACSDuet™ Base system requires a power supply of 100–240 VAC ±10% / 6–2.5A / 50–60 Hz.
The FACSDuet™ Premium system requires a power supply of 100–240 VAC ±10% / 8–3.4A / 50–60 Hz.
16 BD FACSDuet™ Sample Preparation System Site Preparation Guide
3
Checklist
Use this checklist to confirm that the site meets the necessary requirements.
18 BD FACSDuet™ Sample Preparation System Site Preparation Guide
Required
Power
Base
100–240 VAC ±10% / 6–2.5A / 50–60 Hz
Premium
100–240 VAC ±10% / 8–3.4A / 50–60 Hz
Base
48.3 × 35.6 × 38.1 cm (19.0 × 14.0 × 15.0 in.)
Premium
64.4 × 35.6 × 38.1 cm (25.4 × 14.0 × 15.0 in.)
Bench space for BD FACSDuet™ with BD FACSLyric™ (and workstation) with clearance (W × D × H)
If the BD FACSDuet™ instrument and the BD FACSLyric™ instrument will be physically integrated:
Temporary table or countertop space of at least 183 × 76 cm (72 × 30 in.) to organize the Premium
components during the upgrade process
Optional
Sink
Chapter 3. Checklist 19
Becton, Dickinson and Company
BD Biosciences
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Milpitas, California 95035 USA
BD Switzerland Sàrl
Route de Crassier 17
Business Park Terre-Bonne
Bâtiment A4
1262 Eysins
Switzerland
Becton Dickinson AG
Binningerstrasse 94
4123 Allschwil
Switzerland
BD Biosciences
European Customer Support
Tel +32.53.720.600
help.biosciences@bd.com
bdbiosciences.com
ClinicalApplications@bd.com