cobas e 411 analyzer

Safety Guide - Version 1.3

Software Version 03-02
(01)07613336183762(8012)03-02
2

Publication information

Publication version Software version Revision date Change description

1.0 02-05, 02-06, & 02-07 November 2016 First version.
1.1 02-08 April 2018 Minor revisions.
1.2 03-01 February 2019 Minor revisions.
1.3 03-02 June 2021 Minor revisions.
y Revision history

Edition notice This publication is for users of the cobas e 411 analyzer.

Every effort has been made to ensure that all the

information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.

Where to find information The User Assistance / Online Help contains all
information about the product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Software reference
• Configuration information
• Background information

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the
analyzer.

The Operator’s Manual focuses on routine operation

and maintenance. The content is organized according to
the normal operation workflow.

cobas® e-library provides access to important updates,

Method Sheets, Value Sheets, and other important
documents from Roche.

The original version of this document is in English. All

translations of this document have been translated from
the original version in English. You can find the original
and translated versions of this document at:
www.dialog.roche.com.

Contact your local affiliate or Roche Service

representative for more information.

Roche Diagnostics
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 3

The cobas e 411 analyzer can be used with all released

tests. Tests approved for use on the instrument are
available under eLabDoc on the Roche DiaLog website:
www.dialog.roche.com.

Privacy notice When you use User Assistance online,

viewing events (topics viewed and searches performed)
and IP addresses are logged. The data collected is for
Roche internal use only and is never forwarded to third
parties. It is anonymized, and after one year it is
automatically deleted. Viewing events are analyzed to
improve User Assistance content and search
functionality. IP addresses are used to classify regional
behavior.

! General attention
To avoid serious or fatal injury, ensure that you are
familiar with the system and safety information before you
use the analyzer.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the analyzer in a way that is not described
in this publication.
r Store all publications in a safe and easily accessible
place.

! Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.

Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.

Images The images in this publication have been added

exclusively for illustration purposes. Configurable and
variable data in screenshots, such as tests, results, or
path names visible therein must not be used for
laboratory purposes.

Warranty Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service

representative or perform such updates with their
assistance.

Roche Diagnostics
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4

Copyright © 2001–2021, Roche Diagnostics GmbH.

All rights reserved.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS E, and ELECSYS are

trademarks of Roche.

All other trademarks are the property of their respective

owners.

Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of
this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any such feedback.

Approvals The cobas e 411 analyzer complies with the following

directives and regulations:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical
devices.

Regulation (EU) 2017/746 of the European Parliament and

of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU.

Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.

Directive (EU) 2015/863 of 31 March 2015 amending

Annex II to Directive 2011/65/EU of the European
Parliament and of the Council as regards the list of
restricted substances.

Compliance of specific instruments with the respective

directives or regulations is provided by means of the
Declarations of Conformity where applicable.

Check the serial number of the instruments to identify the

applicable directives and/or regulations.

All documents are available under eLabDoc on the Roche

DiaLog website: www.dialog.roche.com.

If you are unable to access Roche DiaLog, contact your

Roche Service representative.

Compliance is provided by means of the Declaration of

Conformity.

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 5

The following marks demonstrate compliance.

Complies with the provisions of the applicable EU

regulations.

For in vitro diagnostic use.

Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

Issued by CSA Group for Canada and the US.

Instrument approvals Furthermore, the instrument is manufactured and tested

according to the following international safety standards:
• IEC 61010-1
• IEC 61010-2-101

The instrument complies with the emission and immunity

requirements described in standard IEC 61326-2-6/
EN 61326-2-6.

Roche Diagnostics
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6

Contact addresses

Inside the European Union and

EFTA member states

Manufacturer of Hitachi High-Tech Corporation

the instrument 1-17-1 Toranomon Minato-ku,
Tokyo, 105-6409 Japan

Authorized Roche Diagnostics GmbH

representative and Sandhofer Strasse 116
Importer 68305 Mannheim
Germany

Outside the European Union and

EFTA member states

Manufactured by: Hitachi High-Tech Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany

Distributed in USA by: Roche Diagnostics

9115 Hague Road Indianapolis,
Indiana, USA

Roche affiliates A list of all Roche affiliates can be found at:

www.roche.com/about/business/roche_worldwide.htm

eLabDoc Electronic user documentation can be downloaded under

eLabDoc on the Roche DiaLog website:

www.dialog.roche.com

For more information, contact your local affiliate or Roche

Service representative.

Roche Diagnostics
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 7

Table of contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Intended use and intended purpose . . . . . . . . . . . 8
Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 9
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
About operator qualification . . . . . . . . . . . . . . . . . . 15
About safe and proper use of the system . . . . . . . 16
About the protection of personal data and
software security. . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Miscellaneous safety precautions overview . . . . . 22
Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Sharps, rough edges, and/or moving parts. . . . . . 23
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 24
Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Burns due to hot surfaces . . . . . . . . . . . . . . . . . . . . 27
Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Reagents and other working solutions . . . . . . . . . 29
Fatigue due to long hours of operation . . . . . . . . . 31
Electromagnetic interference . . . . . . . . . . . . . . . . . 31
Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Electromagnetic compatibility. . . . . . . . . . . . . . . . . 32
Heat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Incorrect results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Analyzer damage . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Safety labels on the system. . . . . . . . . . . . . . . . . . . . . . 35
List of safety labels on the system . . . . . . . . . . . . . 35
Location of safety labels on the system. . . . . . . . . 37
Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 40
Barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Safety information for disposal . . . . . . . . . . . . . . . . . . . 41

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8 Preface

Preface
Use this publication together with the
cobas e 411 analyzer Operator’s Manual.

Operation and maintenance actions are described in the

Operator’s Manual and Online Help.

Intended use and intended purpose

Intended use for US only The cobas e 411 analyzer is an automated,
random-access, multichannel analyzer for immunological
analysis. It is designed for both quantitative and
qualitative in vitro determination of a wide range of
analytes by use of electrochemiluminescence (ECL)
technology.

Supporting information for US only This analyzer is designed for clinical immunological test
analysis using water-soluble samples and reagents. Other
analyses may not be applicable to this analyzer. For
clinical tests, the analyzer should be used under the
management of a doctor or clinical inspector.

Intended purpose for EU/EFTA and outside US The cobas e 411 analyzer is an automated analyzer
including software, intended for running qualitative, semi-
quantitative and quantitative immunochemistry assays.

Supporting information for EU/EFTA and It is an IVD device intended to be used in combination
outside US with assays for screening, monitoring (aid in monitoring),
diagnosis (aid in diagnosis) and prognosis; additionally,
the device can be used to run companion diagnostic
tests.

The specific disorder and testing populations are covered

by the applicable assays running on the instrument. The
type of specimen to be used includes serum, urine,
cerebrospinal fluid, oral fluid, hemolysate and plasma that
are used for detecting and/or measuring analytes covered
by the specific assays.

The intended users of this device are trained laboratory

technicians and trained field service engineers
(professional use only).

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 Preface 9

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the
following product names and descriptors are used.

Product name Descriptor

cobas e 411 analyzer analyzer, system
cobas e 411 software software
y Product names

Symbols used in the publication

Symbol Explanation
o List item
u Related topics containing further information
q Tip. Extra information on correct use or useful
hints.
r Start of a task
I Extra information within a task
f Result of a user action within a task
c Frequency of a task
n Duration of a task
d Materials that are required for a task
j Prerequisites of a task
u Topic. Used in cross-references to topics.
p Task. Used in cross-references to tasks.
w Figure. Used in figure titles and cross-
references to figures.
y Table. Used in table titles and cross-references
to tables.
z Equation. Used in cross-references to
equations.
Material reference number

Search. Used on the search tab.

Table of content. Used on the table of content

tab.
History. Used on the history tab to show
previously viewed topics.
Favorites. Used on the favorites tab and on the
content panel.
Enlarge. Button used on images.

Settings. Button used to open the settings

dialog.
Contact. Used in the User Assistance.
Functionality currently unavailable.
y Symbols used in the publication

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10 Preface

Symbols used on products

Symbol Explanation

Global Trade Item Number

Consult instructions for use on this website:

www.dialog.roche.com

Quantity contained in the package

Quantity contained in the package

Product order

Serial number

Date of manufacture

Manufacturer

Orientation of the package during

transportation

Authorized representative in the European

Community

Indicates the entity importing the medical

device into the European Union

Complies with the directives on the restriction

of hazardous substances

y Symbols used on products

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 Preface 11

Symbol Explanation

Unique device identifier

Indicates that the equipment is suitable

foralternating current only

Catalogue number

Lot number

Single use

Use by date

Humidity limit

Temperature limit

Caution

y Symbols used on products

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12 Preface

Abbreviations The following abbreviations are used.

Abbreviation Definition
AD Amplification and detection
ADC Analog-digital converter
ANSI American National Standards Institute
CFR Code of Federal Regulations
CSA Canadian Standards Association
CSV Comma-separated values
CV Coefficient of variation
DIL Diluent
EC European Community
ECL Electrochemiluminescence
EFTA European Free Trade Association
EN European standard
EU European Union
FCC Federal Communications Commission
GNU GNU’s Not Unix!
HIS Hospital information system
IEC International Electrotechnical
Commission
ISO International Organization for
Standardization
IVD In vitro diagnostic
IVDR In vitro diagnostics regulation:
Regulation (EU) 2017/746
LIS Laboratory information system
LLD Liquid level detection
n/a Not applicable
PSM Pre-analytics system manager
QC Quality control
RoHS Restriction of Hazardous Substances
SD Standard deviation
sdta Sample disk tube adapter
SLLD Sample liquid level detection
SOP Standard operating procedure
STAT Short turn-around time
UL Underwriters Laboratories Inc.
USB Universal serial bus
WEEE Waste Electrical and Electronic
Equipment
y Abbreviations

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 Introduction 13

Introduction
! General attention
To avoid serious or fatal injury, read this publication
thoroughly before you use the analyzer.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the analyzer in a way that is not described
in this publication.
r Keep this publication in a safe place to ensure that it
is not damaged and remains available for use.
This publication must always be easily accessible.

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14 Safety classifications

Safety classifications
The safety precautions and important user notes are
classified according to the ANSI Z535.6 standard.
Familiarize yourself with the following meanings and
icons:

! Safety alert
r The safety alert symbol is used to alert you to potential
physical injury hazards. Obey all safety messages that
follow this symbol to avoid possible damage to the
system, injury, or death.

These symbols and signal words are used for specific

hazards:

! WARNING
Warning...
r ...indicates a hazardous situation which, if not avoided,
could result in death or serious injury.

! CAUTION
Caution...
r ...indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.

NOTICE
Notice...
r ...indicates a hazardous situation that, if not avoided,
may result in damage to the system.

Important information that is not safety relevant is

indicated with the following icon:

q Tip...
...indicates additional information on correct use or useful
tips.

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 Safety precautions 15

Safety precautions
! To avoid serious or fatal injury, read and
comply with the following safety precautions.

In this section
About operator qualification (15)
About safe and proper use of the system (16)
About the protection of personal data and software
security (18)
Miscellaneous safety precautions overview (22)

About operator qualification

Insufficient knowledge and skills As an operator, ensure that you know the relevant safety
precaution guidelines and standards, and the information
and procedures contained in these instructions.
r Do not carry out operation and maintenance unless
Roche Diagnostics has trained you to do so.
r Leave maintenance, installation, or service that is not
described to trained Roche Service representatives.
r Carefully follow the procedures specified in the
instructions for operation and maintenance.
r Follow good laboratory practices, especially when you
work with biohazardous material.

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16 Safety precautions

About safe and proper use of the system

Missing personal protective equipment Working without personal protective equipment means
danger to life or health.
r Wear appropriate personal protective equipment,
including, but not limited to, the following items:
o Eye protection with side shields
o Fluid-resistant laboratory coat
o Approved lab gloves
o Face shield if there is a chance of splashing or
splattering
r Follow good laboratory practices and regularly change
lab gloves to minimize the risk of infection and
contamination, especially after contact with waste or
sample material.

Exposure to chemicals r Avoid exposure to chemicals.

Exposure to infectious waste Failure to place an appropriate waste container at the

waste outlet can lead to exposure to infectious waste
material.
r Always place a waste container at the waste outlet
during operation.
r Follow good laboratory practices and regularly change
lab gloves to minimize the risk of infection and
contamination, especially after contact with waste or
sample material.

Regular cleaning To prevent inaccurate results and unsafe operation of the

system:
r Regularly clean and/or decontaminate the analyzer as
required. Follow good laboratory practices for
cleaning and decontamination.
r Ensure that the laboratory is regularly cleaned and is
maintained in an orderly manner.

Approved cleaning solutions r Use only approved cleaning solutions for cleaning.

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 Safety precautions 17

Errors in installation Only trained Roche Service representatives may install

the system.
r Leave installation that is not described to trained
Roche Service representatives.

Exchange or removal of parts Unauthorized exchange or removal of system parts can

damage the system or stop it from functioning correctly.
r Do not exchange or remove any part of the analyzer.
r Leave replacement of analyzer parts to trained Roche
Service representatives.

Unsuitable environmental conditions Operation outside of the specified ranges may lead to
incorrect results or malfunction of the system.
r Use the system indoors only, and avoid heat and
humidity outside of the specified range.
r Make sure that the system's ventilation openings
always remain unobstructed.
r To maintain the environmental conditions of the
system, perform maintenance in accordance with the
specified intervals.
r Keep the operating instructions undamaged and
available for use. Operating instructions must be
easily accessible for all users.
u For the allowable environmental conditions, see the
user documentation.

Non-approved spare parts Use of non-approved spare parts or devices may result in
malfunction of the system and may render the warranty
null and void.
r Use only spare parts and devices approved by Roche
Diagnostics.

Non-specified third-party software Installation of third-party software is not approved by

Roche Diagnostics and may result in malfunction.
r Do not install third-party software.

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18 Safety precautions

Non-specified consumables Use of non-specified consumables can lead to incorrect

results.
r Do not use consumables that are not intended for use
with the system.
u For a list of supported materials, see the user
documentation.

About the protection of personal data and software

security
The General Data Protection Regulation (GDPR) is a
regulation in EU law on data protection and privacy for all
citizens of the European Union (EU) and the European
Economic Area (EEA). The regulation also covers the
processing of personal data outside the EU and EEA.

If this regulation or any other privacy protection

regulation is applicable for your country, observe the
following safety messages to prevent data breaches and
to meet the GDPR:

Access control Unauthorized access may lead to data breaches.

r Implement physical access controls to ensure that
only authorized laboratory staff operate the system at
all times.
r Assign a personal, unique user ID to each user for
system access.
r Assign access rights to each user only as high as
required for the tasks of the user.
r Delete user IDs from the system for users who no
longer work on the system.

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 Safety precautions 19

Corrupt data due to a disclosed password The security of the system and its data depends on the
password-protected access. If an unauthorized person
discovers your user ID and password, they could
compromise this security.
r Always enter your password unobserved.
r Do not write down your password anywhere, including
in a contact form, in the address book, or in a file on
the computer.
r Do not disclose your password to anyone. Roche will
never ask you for your password.
r If you ever disclose your password to anyone, change
it immediately afterwards.
r Contact your local Roche affiliate if you think your
account has been compromised.

Network security Malicious software and hacker attacks may impair IT

security. The laboratory is responsible for the IT security
of their IT infrastructure.
r To protect and separate Roche systems from other
laboratory infrastructure, the Roche-provided firewall
must be used.
r Secure all devices and services used in the lab
infrastructure against malicious software and
unauthorized access.
r Secure the network environment to be resilient
against traffic redirection and eavesdropping.

Data entry and data transfer Writing patient sensitive information in comment fields
can violate protection laws for protected health
information.
r Do not write any patient sensitive information into
comment fields.
r Do not download patient identifiers from any host
system (e.g., LIS, middleware, or HIS) onto the system.
Data transfer using any host protocol (e.g., ASTM) is
not encrypted; data is transferred as plain text and
readable with IT tools like sniffer.

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20 Safety precautions

Secure data storage Unauthorized access to data backups and archive files
can violate data protection laws.
r Any data backup or data archive that has been
exported from the instrument must be physically
stored in a secured location.
r Ensure only authorized persons may access the
secure data storage. This includes the data transfer to
remote storage locations and disaster recovery.
r Data backups must not be taken from the secure data
storage. Do not take external storage media outside
the lab environment.

Cybersecurity and privacy awareness Insufficiently informed employees can endanger security.
r Perform regular cybersecurity and privacy awareness
trainings for laboratory staff handling personal data.
Instruct laboratory staff how to handle data in a
compliant way and according the privacy principles as
mandated by customer regulations.
r Check your instrument for suspicious activity and
report any suspected compromise to your local Roche
representative immediately.
r Update to the latest software versions provided by
Roche as soon as possible.
r Do not use external storage devices or storage media
(e.g., USB flash drives or DVDs) on the system that
have been used on public or private computers.
Failure to do so may result in data loss and render the
instrument unusable.

Use of storage media Incorrect handling of storage media may result in data
loss or system malfunction.
r Insert or remove a DVD only when the instrument is in
Standby mode.
r Do not use low quality or damaged DVDs (e.g.,
scratches, dirt, or dust on disks).
r At any one time only one storage medium can be in
use. Before inserting a USB flash drive into a USB port,
check that no other USB flash drive is connected and
no DVD is inserted.
r Before removing a USB flash drive, safely disconnect it
from the system using the corresponding button.

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 Safety precautions 21

Computer viruses If you detect an unexpected operation or program/data

damage, the PC may be infected with a computer virus.
r To avoid virus infections, scan removable storage
media by an antivirus software before using them on
the system.
r Never use a program or storage medium that is
suspected of containing a virus.
r If you think your PC is infected with a computer virus,
call your local Roche Service representative. Your
local Roche Service representative will check your
system for proper functionality.

Data backup Data may get lost due to hard disk failures or damages.
r Back up your data (measurement results and system
parameters) at regular intervals.
r Use the backup function daily to store relevant data
on the hard disk.
r Make a backup copy if you have changed any system
parameters.

Non-approved third-party software Installation of any third-party software that is not

approved by Roche Diagnostics may result in incorrect
behavior by the system.
r Do not copy or install any software or software
patches on the system unless it is part of the system
software or your Roche Service representative advises
it.
r Do not change any PC settings.

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22 Safety precautions

Miscellaneous safety precautions overview

Power interruption A power failure or momentary drop in voltage may

damage the system or lead to data loss.
r It is recommended to use an uninterruptible power
supply (UPS).
r Ensure regular maintenance of the UPS.
r Perform regular backup of results.
r Do not switch off power while the control unit
accesses the hard disk or storage device.

Electromagnetic compatibility This analyzer complies with the standard IEC 61326-2-6 /
EN 61326-2-6. It 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 operation of the device.
• Do not operate this analyzer in close proximity to
sources of strong electromagnetic fields (for example
unshielded intentional RF sources), as these may
interfere with the proper operation.

The cobas e 411 analyzer complies with the emission

requirements described in this part of the FCC CFR 47,
Part 15 Class A.

System not used for an extended period r Follow the standard decommissioning procedure.
r Set the main circuit breaker switch to OFF if you do
not use the system for an extended period.
r Remove and refrigerate any remaining reagents and
controls.
r For further information, call your Roche Service
representative.

Damage in transit r Do not attempt to relocate or transport the system.

r Leave relocation and transportation to Roche Service
representatives.

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 Warning messages 23

Warning messages
! List of warning messages
Failure to observe warning messages may result in death
or serious injury.
r Before operating the system, read the warning
messages carefully.
In this section
Sharps, rough edges, and/or moving parts (23)
Electrical safety (24)
Biohazardous materials (24)
Waste (26)

Sharps, rough edges, and/or moving parts

Personal injury and infection due to sharps, Good Laboratory Practice can reduce the risk of injury. Be
rough edges, and/or moving parts aware of your laboratory environment, well-prepared, and
follow the instructions for use.
Some areas of the instrument may have sharps, rough
edges, and/or moving parts.
r Wear personal protective equipment to minimize the
risk of injury from bodily contact with such parts,
especially in less accessible areas, or while cleaning
the instrument.
r Your personal protective equipment should be
appropriate to the degree and type of potential
hazard, e.g. suitable lab gloves, eye protection, lab
coat, and footwear.

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24 Warning messages

Electrical safety

Electric shock Removing the covers of electronic equipment can cause

electric shock because there are high-voltage parts
inside.
r Do not attempt to work on any electronic equipment.
r Do not remove any cover of the system except those
covers specified in the instructions.
r Do not open the top cover and touch the microbead
mixer during operation, or when the analyzer is
performing maintenance.
r Only Roche Service representatives may install,
service, and repair the system.

Disconnecting power supply Disconnecting the analyzer incorrectly from the mains
power supply can cause an electric shock.
r Set the main circuit breaker switch to OFF, then
remove all power supply cords. Rack systems can
have more than one power supply cord.

Biohazardous materials

Infectious samples Contact with samples containing material of human origin

may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow good laboratory practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply disinfectant.
Consult a physician.

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 Warning messages 25

Operator infection and injury Contact with system mechanisms, for example, syringes,
tubes, waste containers, reservoirs, S/R probe, sipper
probe, rinse stations, or with the system chassis or covers,
may result in personal injury and infection.
r Whenever possible, keep the top cover and the front
cover of the system closed.
r Always ensure that the system is off, or in
Maintenance mode or Shutdown status, before you
work with an opened cover, for example, for cleaning
or maintenance.
r Do not open the top cover while the system is
performing maintenance.
r Make sure the covers are fully open to avoid hitting
your head.
r Pay attention to the covers during automatic
movement, check for obstructions and keep out of
reach.
r Do not touch any parts of the system other than those
specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this safety
guide.

Sharp objects Contact with probes may result in infection.

r When you wipe probes, use several layers of lint-free
cloth and wipe from the top down.
r Take care not to puncture yourself.
r Wear appropriate personal protective equipment.
Take extra care when working with lab gloves. They
can easily be pierced or cut, leading to infection.

Smoke due to electrical malfunction Electrical malfunction can result in the emission of
hazardous smoke. Inhaling smoke emitting from the
analyzer can lead to personal injury.
r If you see smoke coming from the analyzer:
o Avoid inhaling
o Disconnect the analyzer from the power supply
o Contact your Roche service representative
immediately

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26 Warning messages

Troubleshooting procedures Corrective measures in troubleshooting procedures can

result in exposure to biohazardous materials.
r Always follow the troubleshooting procedures given in
software wizards and/or in the user documentation.
r Wear appropriate personal protective equipment
when implementing corrective measures.

Waste

Infectious waste Contact with solid waste or waste solution may result in
infection. All materials and mechanical components
associated with waste systems are potentially
biohazardous.
r Wear appropriate personal protective equipment.
Take extra care when working with lab gloves. They
can easily be pierced or cut, leading to infection.
r If any biohazardous material is spilled, wipe it up
immediately and apply disinfectant.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply disinfectant.
Consult a physician.

Environmental harm The system generates liquid and/or solid waste. Liquid
waste contains concentrated reaction solutions. Solid
waste is potentially biohazardous. Improper disposal may
contaminate the environment.
r Treat liquid and solid waste as infectious waste.
r Dispose of waste in accordance with the local laws
and regulations. Any substances contained in
reagents, calibrators, and controls must be disposed
of according to the relevant water discharge facility
regulations.
r Contact the reagent manufacturer for information
about the concentration of heavy metals and other
toxic constituents of reagents, or for legal regulations
on water discharge.
r Take extra care when pouring ProCell and CleanCell
down the drain, as they may produce toxic gases. Run
the tap continuously to ensure that the waste is
diluted.

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 Caution messages 27

Caution messages
! List of caution messages
r Before operation, read the caution messages carefully.
Failure to observe them may result in minor or
moderate injury.
In this section
Burns due to hot surfaces (27)
Mechanical safety (28)
Reagents and other working solutions (29)
Fatigue due to long hours of operation (31)
Electromagnetic interference (31)

Burns due to hot surfaces

Hot surfaces inside Contact with some surfaces may cause burns. The
temperature of the heating station can reach up to 85 °C.
r Avoid contact with hot surfaces inside the analyzer
indicated with a warning label.
r Use caution near the heating station and sealing
station following an emergency stop.
r Be careful if you open the analyzer covers after an
analyzer error. Wait a few minutes to let the heating
station cool down before you reach into the analyzer.

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28 Caution messages

Mechanical safety

Damaged touchscreen monitor Damage to the touchscreen monitor can expose sharp
edges, which can cause personal injury if touched.
r Do not touch the touchscreen monitor if it is visibly
damaged.
r Contact your Roche Service representative.

Touchscreen monitor Risk of personal injury when moving the touchscreen

monitor towards the system housing. Your hand can be
pinched between the touchscreen monitor and the
housing.
r Use caution when moving the touchscreen monitor in
front of the system housing.
r Keep your fingers away from the gap between the
touchscreen monitor and the system housing when
moving the touchscreen monitor towards the housing.

Moving parts Contact with moving parts may result in personal injury or
damage to the analyzer.
r Keep all covers closed and in place while the system is
operating.
r Always ensure that the system is off, or in Shutdown
status, before you work with an opened cover, for
example, for cleaning or maintenance.
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
r Take care not to pinch your fingers or hand when
closing the rack sampler cover.
r During operation and maintenance, carefully follow
the instructions.
r Before you load or unload items on the reagent disk,
sample disk or rack sampler, ensure that the analyzer
is not in operation.

Loading and unloading racks and trays Incorrect loading and unloading of racks and trays may
damage the analyzer or cause operation to stop.
r When the analyzer is in operation, ensure that the
light on the rack sampler is green before you load
samples on the A-Line or unload samples from the
C-Line.
r Do not add or remove single AssayCups and
AssayTips to a tray when it is on the analyzer.

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 Caution messages 29

Reagents and other working solutions

Skin inflammation or injury Direct contact with reagents, detergents, cleaning

solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling laboratory reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Instructions for
Use for the test.
r Observe the information given in Material Safety Data
Sheets, available for Roche Diagnostics reagents and
cleaning solutions.
r If reagents, detergents, or other cleaning solutions
come into contact with your skin, wash the affected
area immediately with soap and water and apply
disinfectant.
Consult a physician.

Fire and burns Alcohol is a flammable substance.

r Keep all sources of ignition, such as sparks, flames, or
heat, away from the system when you perform
maintenance or checks that involve alcohol.
r When you use alcohol on or around the system, use
no more than 20 mL at a time.

Incorrect reagent volume Incorrect reagent handling may cause an undetectable

loss of reagent.
r Always store reagents according to the specified
storage conditions as stated in the Instructions for Use
for the test.
r Do not use a reagent pack or reagent bottle whose
reagent has spilled.

Foam, clots, films, or bubbles Incorrect results may occur due to foam, fibrin clots, films,
or bubbles in reagents or samples.
r Ensure good sample preparation and reagent
handling techniques to avoid the formation of foam,
clots, and bubbles in all reagents, samples, and
controls.

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30 Caution messages

Contaminated samples Insoluble contaminants, bubbles, or films in samples may

cause clogging or pipetting volume shortage, leading to
incorrect results.
r Make sure that the samples contain no insoluble
contaminants, such as fibrin or dust.

Evaporation of samples or reagents Evaporation of samples or reagents may lead to incorrect

or invalid results.
r Sample material may evaporate if left open. Do not
leave samples open for any length of time.
r Do not use improperly stored reagents. Ensure that
reagents are stored according to the Instructions for
Use.
r The system does not allow the use of expired
reagents.

Incorrect results due to incorrect handling of Incorrect handling of reagents or other consumables may
reagents lead to incorrect results.
r Do not use reagents that were exposed to heat or to
light for an extended time.

r Adhere to the storage conditions defined in the

Instructions for Use for the reagents, controls, and
consumables. Do not store reagents below 2 °C as the
microbeads must not be frozen.
r Do not use reagents or consumables that have been
dropped on the floor or compromised in any other
way.
r Do not manipulate supplies in any way not specified in
the user documentation or Instructions for Use.

Incorrect results due to incorrect handling of Incorrect handling of wash reagent, lysis reagent, or
wash reagent, lysis reagent, or diluent in diluent in containers may lead to incorrect results.
containers r Do not open the containers until they are ready for
use on the analyzer.

Carryover Traces of analytes or reagents may be carried over from

one test to the next.
r Take adequate measures, for example, extra wash
cycles, to avoid extra testing and potentially incorrect
results.

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 Caution messages 31

Incorrect use of barcode labels Incorrect use of barcode labels may cause incorrect
results.
r To prevent undetected barcode read errors, use
barcodes with check digits.
r When you attach barcode labels to sample tubes,
ensure they are readable.

Fatigue due to long hours of operation

Fatigue due to long hours of operation Looking at the monitor over an extended time may lead to
eye strain or body fatigue.
r Take a break to relax, in accordance with your
laboratory's SOPs or local regulations.

Electromagnetic interference

Electromagnetic interference Strong electromagnetic fields, originating from

unshielded radio frequency sources, can interfere with
proper operation and may lead to malfunction of the
system and incorrect results.
r Do not use this system near sources of strong
electromagnetic fields because these fields can
interfere with the proper operation.
r Evaluate the electromagnetic environment before you
operate the system.
r Take measures to mitigate the interference.
r Do not use the following devices in the same room as
the analyzer:
o Mobile phones
o Transceivers
o Cordless phones

Wireless interference Wireless devices in the analyzer may lead to malfunction.

r Do not leave mobile phones or other wireless devices
inside the analyzer.

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32 Notices

Notices
! List of notices
Failure to observe the notices may result in damage to the
system.
r Before operating, read the notices contained in this
summary carefully.
In this section
Electromagnetic compatibility (32)
Heat (32)
Incorrect results (33)
Analyzer damage (33)

Electromagnetic compatibility

Class A equipment (industrial areas) r The cobas e 411 analyzer 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.

Heat

Loss of results and reagents due to exposure Exposure to heat may cause the temperature inside of the
to heat system to rise. If the inside temperature is >37 °C or
<2 °C, all reagents on board, and all currently measured
results become invalid.
r Avoid heat sources close to the system.
u See the system specifications in the user
documentation for the allowable environmental
conditions.

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 Notices 33

Incorrect results

Incorrect results due to overfilling the sample Overfilling the sample tubes can lead to spillage during
tubes normal operation and result in contamination and
incorrect results.
r Do not overfill sample tubes.

Analyzer damage

Circuit breakers and fuses Improper use may result in damage to the system.
r If one of the circuit breakers or fuses blows, do not
attempt to operate the system before contacting your
Roche Service representative.

Collision with moving parts Contact with moving parts may bend the probes or
damage other components. If the system detects a
collision, an alarm is raised, stopping the operation
immediately.
r Keep all covers closed and in place during operation.
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.

Damage to motorized parts Manually moving motorized components while the power
is on can damage them.
r Power off the analyzer before attempting to move any
motorized components.

Damage to the measuring cell unit Opening the detection unit cover while the power is on
can damage the photomultiplier.
r Power off the analyzer before attempting to open the
detection unit cover.

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34 Notices

Damage to the system or consumables from Organic solvents may damage the system and
organic solvents consumables.
r Do not use organic solvents to clean or dry
AssayCups, AssayTips, or the waste solution path.
r Do not use organic solvents, other than isopropyl
alcohol or ethanol, for performing system checks or
maintenance.

Damage to the system due to mechanical Shock, vibration, or pressure can damage the system.
stress r Keep sources of vibration away from the system.
r Do not place objects on the system.

Spilled liquid Any liquid spilled on the system may result in malfunction
or damage.
r Place samples, reagents, or any other liquid only at the
intended positions.
Do not place samples, reagents, or any other liquid on
the covers or other surfaces of the system.
r When you remove or replace consumables, do not
spill any liquid on the system.
r If liquid does spill on the system, wipe it up
immediately and follow the applicable
decontamination procedure. Wear appropriate
personal protective equipment.
Dispose of waste according to the local regulations.

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 Safety labels on the system 35

Safety labels on the system

In this section
List of safety labels on the system (35)
Location of safety labels on the system (37)

List of safety labels on the system

Warning labels are placed on the system to draw your
attention to areas of potential hazard. Listed below are
labels and their definitions according to the location on
the system.

The safety labels on the system comply with the following

standards: ANSI Z535, IEC 61010-1, IEC 60417, ISO 7000,
or ISO 15223-1.

In addition to the safety labels on the system, there are

safety notes in the corresponding parts of the user
documentation.

q Only Roche service personnel are to replace

damaged labels. For replacement labels, contact your
local Roche representative.

General warning
Potential hazards located near this label may lead to
death or serious injury.
Refer to the user documentation for instructions on safe
operation.

Biohazard
Potentially biohazardous materials are used near this
label.
Observe relevant good laboratory practices on safe
usage.

Moving parts
There is a risk of hand injuries from moving parts near
this label.
Keep hands away from moving parts.

Laser transmitter
There is a danger of contact with laser light or severe
damage to the eyes.
Do not stare into the laser transmitter.

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36 Safety labels on the system

Corrosive materials
There is a danger of contact with corrosive or caustic
material.
Wear appropriate personal protective eye protection and
gloves.

STAT rack orientation

There is a risk of damage to the system if the rack in the
STAT port is inserted backwards.
Position the rack into the STAT port with the same
orientation as on the label.

SysWash
Incorrect SysWash dilution could affect test results.
When refilling the system water container, add 35 mL of
SysWash to the deionized water, for a 100+1 dilution
ratio.

The safety messages give more detailed information

about potentially hazardous situations that may arise
during daily operation, or when carrying out maintenance
actions.

When working with the system, observe both the safety

labels on the system and the safety messages in the user
documentation.

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 Safety labels on the system 37

Location of safety labels on the system

w Safety labels on the analyzer unit (disk system)

w Safety labels on the analyzer unit (rack system)

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38 Safety labels on the system

w Safety labels on the solid waste tray and Clean-Liner

w Safety label on the circuit breaker of the analyzer

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 Safety labels on the system 39

w Safety labels on the circuit breaker of the analyzer (rack system)

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40 Safety information for lasers

Safety information for lasers

The cobas e 411 analyzer has two laser barcode readers.
• A laser barcode reader (class B) is used to scan
barcodes on primary sample tubes, calibrators,
controls, and reagents.
• A laser barcode reader (class 2) is used to scan
sample barcodes and rack ID barcodes.

Barcode reader
The barcode readers are class 2 laser products, lowest
class.

The mentioned classes refer to the standard IEC 60825-1:

• Class 1: Eye-safe under normal operating conditions.
• Class 2: Visible lasers. Eye-safe for accidental viewing.
It may not be safe to deliberately stare into the laser
beam for longer than 0.25 s, overcoming the natural
aversion response to the bright light.

Wavelength Operating voltage Max. output Remark

650 nm 10-30 V(DC) 0.81 mW Class 1 laser
655 nm 10-30 V(DC) 1.7 mW Class 2 laser
y Lasers on the system

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 Safety information for disposal 41

Safety information for disposal

Infection by an infectious instrument r Treat the instrument as infectious waste.

Decontamination (the combination of processes
including cleaning, disinfection, and/or sterilization) is
required before reuse, recycling, or disposal of the
instrument.
r After decontamination, still treat the instrument as
potentially infectious as there might be a remaining
risk.
r Dispose of the instrument according to the local
regulations. For more information, contact your Roche
Service representative.

Electronic equipment

Disposal of electronic equipment

This symbol appears on any component of the system
that is covered by the European Directive on Waste
Electrical and Electronic Equipment (WEEE).

You must dispose of these items through designated

collection facilities appointed by government or local
authorities.

Contact your city office, waste disposal service, or your

Roche Service representative for more information about
disposal of your old product.

Constraint:
It is left to the responsible laboratory organization to
determine whether electronic equipment components are
contaminated or not. If contaminated, treat them in the
same way as the system.

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42 Safety information for disposal

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