General Safety and

Regulatory Information

514722-1EN1 – (08/2011)

[05]
Table of Contents

Legal Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Important Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Statement Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
General Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Standard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

i General Safety and Regulatory Information

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1 Legal Statements

The following statements apply to all bioMérieux publications unless stated otherwise in the publication.

Liability Disclaimer

THIS MANUAL IS PROVIDED "AS IS" WITHOUT ANY WARRANTY, EITHER EXPRESS OR IMPLIED,
OF MERCHANTABILITY, SAFETY, QUALITY, ACCURACY OR THE PERFORMANCE OF PRODUCTS
DESCRIBED IN THIS MANUAL. IN ADDITION, BIOMÉRIEUX MAKES NO IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NOR NON INFRINGEMENT OF
THIRD PARTIES' INTELLECTUAL PROPERTY RIGHTS.

In no event shall this manual be construed as an undertaking of bioMérieux. BIOMÉRIEUX MAKES NO

EXPRESS OR IMPLIED WARRANTY REGARDING MANUALS, THEIR QUALITY, PERFORMANCE,
OR APPROPRIATE USE REGARDING ANY TYPE OF SPECIFIC PROCEDURE.

In no event shall bioMérieux be liable for any consequential, incidental or indirect damage or
consequence related to, arising out of or in connection with, any use of this manual and/or its results by
the user and/or any third party.

bioMérieux reserves the right to modify this manual without notice and shall incur no liability as a result of
such modification.

This manual is provided for information purposes only.

Intellectual Property

bioMérieux is the sole owner of copyright, patent rights and any other intellectual property rights in and to
this manual and its content, except for the potential third parties' rights. The rights to use this manual
granted herein are non-exclusive and limited to the extent necessary to use the Software and Instrument.
In no event shall the users be granted any other right to use this manual including without limitation, the
right to reproduce, represent, adapt or translate all or part of this manual by any means whatsoever
without the prior written consent of bioMérieux.

Any use of this manual other than expressly permitted hereunder may be prosecuted.

Trademarks

bioMérieux and the blue logo are registered trademarks belonging to bioMérieux SA.

Any other name or trademark is the property of its respective owner.

©2011 bioMérieux, Inc. All rights reserved.

No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or
translated into any language (human or computer) in any form, or by any means whatsoever, without the
prior express permission of bioMérieux.

IMPORTANT: USE OF THIS MANUAL CONSTITUTES ACCEPTANCE OF THE TERMS AND

CONDITIONS SET FORTH HEREIN.

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 Legal Statements

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2 Important Statements

The user documentation uses several types of statements to alert you to important information. Important
information is labeled in text and also, for more serious statement types, identified using symbols.

Statement Types

The statement types are Danger, Warning, Caution, Important, and Note. The following examples define
each statement type. The general caution symbol is used in these examples, but other symbols (see
Chapter 3, Standard Symbols) may be used instead.

DANGER

A Danger statement alerts the user to the immediate possibility of

injury, death, or other serious adverse reactions associated with a
specific feature of the device or with a specific procedure.

WARNING

A Warning statement alerts the user to the possibility of injury, death,

or other serious adverse reactions associated with the use or misuse
of a device.

CAUTION: A Caution statement alerts the user to the possibility of a problem

with the device associated with its use or misuse. Such problems include device
malfunction, device failure, damage to the device, or damage to other property.
Where applicable, a Caution statement may include a precaution that should be
taken to avoid the hazard.

IMPORTANT: An Important statement relates to content presented in the user documentation.

It is used to reinforce your understanding of selected information.

Note: A Note statement supplies additional information about a topic.

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General Statements Important Statements

General Statements

This section provides important statements that apply to all products. Equipment meets the requirements
and standards stated in the certificate supplied with it.

WARNING

Equipment is intended for professional use only.

Laboratory personnel should be qualified and adhere to the principles

of good laboratory practice.

All the user documents supplied must be read prior to use of the
equipment.

Under no circumstance should the user dismantle equipment owing to

the risk of touching dangerous parts, including parts that are
infectious or connected to a source of electric power.

Do not obstruct the equipment and hardware ventilation apertures,

and leave sufficient clearance around the equipment for the
circulation of air.

All biological fluids should be considered as potentially infectious.

Suitable individual protective equipment is required when handling
chemical or biological substances.

bioMérieux is in no case liable for the harmful consequences of

incorrect use or improper handling of these substances.

WARNING

Electromagnetic Compatibility (EMC):

The EMC class of the equipment is indicated on the certificate
supplied with it.
If equipment is a class A product, it may cause radio interference in a
domestic environment, in which case the user will be required to
correct the interference at his own expense.
Do not use this device near strong sources of electromagnetic
radiation (for example, intentionally unprotected radioelectric
sources), which could interfere with the running of the equipment.
It is recommended to evaluate the electromagnetic environment
before starting up the device.

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Important Statements General Statements

WARNING

In order to avoid computer viruses or abnormal functioning of your

equipment, never download into the computer any programs other
than those provided by bioMérieux.
All computer media (CD, DVD, and so on) supplied with this equipment
should be stored and stocked in a suitable location.
Only modify the software configuration parameters you are authorized
to modify and which are described in the user documentation.

WARNING

Decontamination of equipment at the end of its life cycle:

The instructions below must be followed by all users in countries
where local legislation imposes the treatment and recycling of
equipment at the end of its life cycle.
As a general rule, and as a precautionary measure, any part of the
equipment (including sub-assemblies, components, material, and so
on) considered to be potentially infectious, must be decontaminated,
whenever possible, or removed if decontamination is impossible or
presents a risk.
Any part considered to be potentially infectious, which is not
decontaminated, must be removed from the instrument before
following the normal channels for elimination of infectious products,
in accordance with local regulations.
The decontamination instructions in the user documentation
correspond to the parts of the equipment that are potentially
infectious according to their intended use. These operations must be
performed before the equipment is transferred to a third party.
However, bioMérieux cannot exclude that other parts of the equipment
have not been contaminated in other circumstances, in particular as
the result of spillage of infectious substances. In this case, the user is
solely responsible for decontaminating these parts or removing them
before they follow the normal channels for elimination of infectious
products.

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General Statements Important Statements

WARNING

This statement only applies to European countries with regard to the

waste electrical and electronic equipment European directive:
You can play an important role in contributing to reuse, recycling, and
other forms of recovery of waste electrical and electronic equipment.
Sorting this type of waste significantly reduces potential negative
effects on the environment and human health as a result of the
presence of hazardous substances in electrical and electronic
equipment.
At the end of the life cycle of this product, do not dispose of the
product as unsorted municipal waste, even if it is decontaminated. It is
imperative that you contact bioMérieux to assure for its appropriate
disposal.

IMPORTANT: Electrical or other connections should only be done using the accessories
supplied with the equipment.

IMPORTANT: It is important to follow all the restrictions on use, particularly concerning

temperature, storage, installation, voltage, and so on, which are indicated on the
product label or in the user documentation.

IMPORTANT: The accuracy of results obtained with this equipment depends on the
maintenance operations described in the user documentation (user
maintenance and/or periodic preventive maintenance performed by bioMérieux).

IMPORTANT: The user should be aware that if the maintenance operations are not performed,
are only partially performed, or are not performed as described in the user
documentation, bioMérieux is in no case liable for any false test results
obtained.

IMPORTANT: It is recommended to keep the original packaging materials in case the

equipment needs to be moved. Any damage directly or indirectly resulting from
the transport of the equipment without adequate containers will not be covered
by the warranty.

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3 Standard Symbols

The following table defines symbols that may appear in the instructions for use or on the instrument,
package inserts, or packaging.

CE-Marking of Conformity Potential pinch-point warning

Consult Instructions for Use

Laser

Use by Shearing hazard

High temperature
Manufacturer

Hazardous magnetic field

Date of manufacture

Potential tip over/crush hazard

Contains sufficient for <n> tests

Temperature limitations

Keep dry
Upper limit of temperature

Fragile, handle with care

Lower limit of temperature

Caution, consult accompanying

Keep away from magnetic field
documents

In Vitro Diagnostic Medical Device

Biological risk

Batch code

Electric shock warning

Authorized Representative in the
European Community

Radiation warning Catalog number

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 Standard Symbols

Serial number
Humidity limitation

Sterile

Fuse

Do not reuse
Direct current

Alternating current
Recyclable
Both direct and alternating current

Three-phase alternating current

Separate collection for waste electrical
and electronic equipment

Earth (ground) terminal

Very toxic
Protective conductor terminal

Corrosive
Frame or chassis terminal

Sodium azide
Equipotentiality

Irritant

ON (supply)

Positive control

OFF (supply)

Negative control

ON (only for a component of the system

equipment)
Keep away from sunlight

OFF (only for a component of the system

equipment)
Protect from light
Equipment protected throughout by
double insulation or reinforced insulation
(Equivalent to Class II of IEC 536)
This way up
Environmentally friendly use period.
Actual number of years may vary by
product. This symbol is typically
Do not stack orange in color.

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