c5800 Safety Guide

cobas® 5800 System
Safety Guide
Publication version 2.1
Software version 1.0
2
Publication information
Publication version Software version Revision date Change description
1.0 1.0 May 2021 First edition

2.0 1.0 April 2022 Update of safety message. Do not enter sensitive data into
open text fields, like the comment field or the sample ID
field.
u About personal and confidential data (26)

2.1 1.0 November 2022 Update of warning message. Only use consumables
approved for the system to avoid incorrect results.
u About incorrect results (21)

y Revision history
Edition notice This publication is intended for users of the

cobas® 5800 System.
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 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
instrument.
The User Guide focuses on routine operation and

maintenance. The content is organized according to the
normal operation workflow.
The Quick Reference Guide gives a brief introduction

to important routine tasks and daily maintenance.
The Host Interface Manual provides references for

implementing connections from external laboratory
information systems (LIS) to the product.
Roche Diagnostics
cobas® 5800 System · Software version 1.0 · Safety Guide · Publication version 2.1
3
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 system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument 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.
Images The screenshots and hardware 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 perform software updates in accordance with the

instructions described in the user documentation and
instructions delivered with the software packages.
Copyright © 2023, F. Hoffmann-La Roche Ltd. All rights reserved.
Roche Diagnostics
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License information The cobas® 5800 System software is protected by

contract law, copyright law, and international treaties.
The cobas® 5800 System software contains a user
license between F. Hoffmann-La Roche Ltd. and a
license holder, and only authorized users may access the
software and use it. Unauthorized use and distribution
may result in civil and criminal penalties.
Open-source and commercial software The cobas® 5800 System may include components or
modules of commercial or open-source software. For
further information on the intellectual property and other
warnings, as well as licenses pertaining to the software
programs included in cobas® 5800 System, refer to the
electronic distribution included with this product.
This open-source and commercial software and

cobas® 5800 System as a whole can constitute a device
regulated in accordance with applicable law. For detailed
information, in the software, choose > .
Note that the respective authorization is no longer valid

according to the corresponding legislation should any
unauthorized changes be made to cobas® 5800 System.
Trademarks The following trademarks are acknowledged:
COBAS and COBAS OMNI 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® 5800 System meets the requirements laid

down in:
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.
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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 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
To view the full text of the 2014/53/EU declaration of
conformity, go to the Roche DiaLog global website
(dialogportal.roche.com) and choose the eLabDoc link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.
Compliance with the applicable directives is provided by

means of the declaration of conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU

directives.
Issued by CSA Group for Canada and the US.
Issued by the TÜV SÜD for Canada and the US.
'Laboratory Equipment' is the product identifier as

shown on the name plate.
Contact addresses
Roche Molecular Systems, Inc.

1080 US Highway 202 South
Branchburg, NJ 08876
USA
Made in Switzerland
Roche Diagnostics
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Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Distributed in the United States by:

Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
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 using

the eLabDoc e-service on Roche DiaLog:
dialogportal.roche.com
For more information, contact your local affiliate or

Roche Diagnostics
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Table of contents
Intended use ............................................................................ 9
Product names, symbols, and abbreviations ............... 9
Introduction.............................................................................. 11
Safety classifications............................................................. 12
Safety precautions ................................................................. 13
About safety precautions......................................... 13
About safe and proper use of the system ......... 13
About transportation and installation ................. 14
About operating conditions .................................... 15
About electromagnetic compatibility .................. 15
Warning messages ................................................................ 17
About warning messages ........................................ 17
About biohazardous materials ............................... 17
About waste handling ............................................... 18
About electrical safety .............................................. 19
About sample stability............................................... 20
About reagents and working solutions .............. 20
About incorrect results ............................................. 21
Caution messages ................................................................. 23
About caution messages.......................................... 23
About burns due to hot surfaces .......................... 23
About moving parts.................................................... 24
About magnetic fields ............................................... 24
About data security.................................................... 25
About personal and confidential data ................ 26
Notices ....................................................................................... 28
About notices ............................................................... 28
About spillage .............................................................. 28
About circuit breakers and fuses.......................... 29
About mechanical stress ........................................ 29
About out-of-range temperature.......................... 29
Safety labels on the system................................................ 30
About safety labels on the system........................ 30
List of safety labels on the system ....................... 30
About the location of safety labels on the
system ............................................................................ 31
About substances according to REACH........................ 41
Safety information for disposal ......................................... 42
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Intended use
The cobas® 5800 System supports an automated and

integrated workflow to run polymerase chain reaction
(PCR) based nucleic acid testing (NAT) for use by trained
professionals in laboratory settings. The
cobas® 5800 System combines the functionalities of
instrumentation, consumables, reagents, and data
management to provide an efficient workflow from
sample processing to result interpretation.
Product names, symbols, and abbreviations
Product names Product name Descriptor
cobas® 5800 System System

®
cobas 5800 Instrument Instrument
x800 Data Manager Data manager
y Product names
Symbols used in the publication Symbol Explanation
o List item
u Cross-reference to another topic
w Figure, used in figure titles and cross-

references to figures
y Table, used in table titles and cross-

references to tables
p Start of a task
q Tip, used for extra information on correct use

or for useful hints
I Extra information within a task
f Result of an 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
y Symbols used in the publication
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Symbols used on the product Symbol Explanation
Catalog number
Global Trade Item Number
Date of manufacture
Manufacturer
In vitro diagnostics
Caution
Serial number
Laboratory equipment
Authorized representative in
the European Community
Three-phase alternating
current
Disposal of control unit

components
Class 2 equipment
Unique device identifier
Indicates the entity importing

the medical device into the
European Union.
Indicates the entity distributing

the medical device within the
European Union.
y Symbols used on the product
Abbreviations The following abbreviations are used.
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Abbreviation Definition
ANSI American National Standards Institute

CISPR Comité International Spécial des
Pertubations Radio électriques
(International Committee on Radio
Interference)
CSA Canadian Standards Association
EC European Community
FCC Federal Communications Commission
IEC International Electrical Commission
ISO International Organization for
Standardization
LAN Local area network
PCR Polymerase chain reaction
REACH Registration, Evaluation, Authorization and
Restriction of Chemicals
RF Radio frequency
RFID Radio frequency identification
TLS Transport Layer Security
UPS Uninterruptible power supply
USB Universal Serial Bus
WEEE Waste Electrical and Electronic Equipment
WLAN Wireless local area network
WPA2 Wi-Fi Protected Access 2
y Abbreviations
Introduction
General attention
To avoid serious or fatal injury, read this publication

thoroughly before you use the instrument.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument 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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Safety classifications
The safety precautions and important user notes are
classified according to the applicable standards.
Familiarize yourself with the following meanings and
icons:
Safety alert
r The safety alert symbol is used to alert you of
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 that, if not avoided,
could result in death or serious injury.
CAUTION!
Caution…
r …indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
NOTICE!
Notice...
...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:
i Tip...
...indicates additional information on correct use
or useful tips.
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Safety precautions
In this section
About safety precautions (13)
About safe and proper use of the system (13)
About transportation and installation (14)
About operating conditions (15)
About electromagnetic compatibility (15)
About safety precautions

To avoid serious or fatal injury, read and
comply with the following 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:
• Eye protection
• Lab coat
• Lab gloves
r Follow laboratory best 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 Direct contact with reagents, wash solutions, cleaning
solutions, or other working solutions might cause skin
irritation, inflammation, or burns.
r Avoid exposure to chemicals.
Regular cleaning To maintain a robust instrument and prevent unsafe

operation of the system:
r Regularly clean the instrument as indicated in the
maintenance schedule.
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Approved cleaning solutions Using non approved cleaning solutions can result in
DNA inactivation and false negative results. Non-
approved cleaning solutions might not be effective on
sample material that has spilled. Using sprayable
cleaning solutions can lead to deposits on needles
which can cause DNA inactivation and false negative
results.
r Use only approved cleaning solutions for cleaning.
r Do not spray cleaning solutions inside the instrument.
u For the list of allowed cleaning solutions, see the user

documentation.
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
instrument except those parts specified in the
maintenance chapter of the User Assistance. Leave
replacement of all other instrument parts to Roche
Service representatives.
Non‑approved spare parts Use of non-approved spare parts or devices may result
in system malfunction and may render the warranty null
and void.
r Use only parts and devices approved by Roche
Diagnostics.
Non-specified consumables Use of non-specified consumables can lead to incorrect

results or damage the system.
r Only use consumables approved for the system.
u For the list of approved consumables, see the user

documentation.
About transportation and installation

Errors in installation Error during installation of a new system or new parts
can cause malfunctions.
r Leave installation activities which are not described to
Roche Service representatives.
Damage during transport Damage during transport can cause malfunctions.

r Do not attempt to relocate or transport the system.
Leave relocation and transportation to Roche Service
representatives.
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About operating conditions

Unsuitable operating conditions Operation outside of the specified ranges may lead to
incorrect processing or malfunction of the system.
r Consult the specifications chapter of the user
documentation.
r Use the system indoors only. Avoid proximity to heat
sources and high radiation, and avoid 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 in the maintenance chapter of the
user documentation.
Power interruption A power failure or momentary drop in voltage may

damage the system or lead to data loss.
r Operate with an uninterruptible power supply (UPS).
The specification of the UPS must comply with the
power requirement of 1.6 kW for the instrument. If the
UPS can barely supply the required power, the
instrument may automatically shut down. Do not
connect other devices to the UPS.
r Ensure periodic maintenance of the UPS.
r Perform regular backups of results.
r To shut down the instrument, in the global

information area, in the status drop-down list, choose
the Shut down option. Only if immediate shutdown is
required, use the power button. If you use the power
button instead of the Shut down option in the
software, all processes are aborted and the results of
all processed samples may be lost.
About electromagnetic compatibility

The system complies with the emission and immunity
requirements described in the parts IEC 61326-2-6 and
IEC 61326-1.
The system complies with the emission requirements

described in FCC CFR 47, Part 15 Class A.
The system has been designed and tested to CISPR 11

Class A.
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This system is designed for use in a professional

healthcare facility environment. In a domestic
environment, the system may cause electromagnetic
interference, in which case you must take measures to
mitigate the interference.
Non-approved accessories, transducers, and Use of non-approved accessories, transducers, and

cables cables can result in increased electromagnetic
emissions and decreased electromagnetic immunity of
the system. It can also result in improper operation.
r Only use accessories, transducers, and cables
specified or provided by the manufacturer of this
system. For more information, contact your Roche
Service representative.
r Only use cable length which complies with EMC
testing:
• USB 2.0: < 3 m
• LAN/Ethernet: < 30 m (longer cable might reduce
speed performance)
• AC power input: < 30 m (longer cable can reduce
the voltage of the system)
Electromagnetic fields RFID electromagnetic fields (30 kHz at 8 A/m, 134.2 kHz
at 65 A/m, 13.56 MHz at 7.5 A/m) are verified and
considered as a negligible risk for the specified system
performance. Stronger electromagnetic fields can result
in degradation of the system performance.
r Evaluate the electromagnetic environment before
operating the device.
r Do not use portable radio frequency (RF)
communications equipment (including peripherals
such as antenna cables and external antennas) closer
than 30 cm to any part of the system, including cables
specified by the manufacturer.
r Do not operate this system close to sources of strong
electromagnetic fields (for example, unshielded
intentional RF sources), as they may interfere with
proper operation. The distance of 30 cm for portable
RF devices (mobile phones, WiFi) is considered as
normal electromagnetic fields for the system.
r Do not use the system in proximity (< 30 cm) to
sources of strong electromagnetic radiation (for
example, microwave ovens, hand-held radio
transmitters, electric motors, RFID emitters), as they
can interfere with proper operation.
r If it is suspected that electromagnetic interference
affects the performance, correct operation may be
restored by increasing the distance between the
system and the source of the interference.
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Warning messages
In this section
About warning messages (17)
About biohazardous materials (17)
About waste handling (18)
About electrical safety (19)
About sample stability (20)
About reagents and working solutions (20)
About incorrect results (21)
About 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.
About 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. Any spillage should be avoided.
r Follow laboratory best practices, especially when
working with biohazardous material.
r Be careful when loading samples.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up

immediately and follow the decontamination
procedure in the maintenance chapter of the user
documentation.
r If sample or solid waste comes into contact with your
skin, wash the affected area immediately with soap
and water and apply a disinfectant.
Consult a physician.
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If an error occurred, sample material might have spilled

Troubleshooting procedures
and you are potentially exposed to biohazardous
material during troubleshooting.
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.
About waste handling

Environmental harm The system generates liquid waste and solid waste.
Liquid waste contains concentrated reaction solutions,
solid waste is potentially biohazardous. Improper
disposal may contaminate the environment.
r Treat solid waste as infectious waste.
r Dispose of waste in accordance with the local

regulations.
Infectious waste Contact with solid waste may result in infection. All
materials and mechanical components associated with
the solid waste system are potentially biohazardous.
r Take extra care even if working with lab gloves. They

can easily be pierced or cut, leading to infection.
procedure in the maintenance chapter of the user
documentation.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant. Consult a physician.
Perforation of solid waste bags Sharp-edged consumables may perforate the solid
waste bag. This perforation can lead to leakage of
potentially biohazardous material and to infection. There
is a risk that you slip.
r Inspect the bag for leakage.

procedure.
r If waste comes into contact with your skin, wash the
affected area immediately with soap and water and
apply a disinfectant. Consult a physician.
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Solid waste bags Attempting to empty and reuse solid waste bags can
result in spillage. Spilled solid waste can lead to
contamination, risk of slipping, and risk of personal
injury during cleanup.
r Always use a solid waste bag.
r Do not attempt to empty and reuse solid waste bags.
r When disposing of solid waste, dispose of the entire

solid waste bag.
r Do not compress the solid waste bags. Pipette tips
might pierce the bags.
Chemical reaction producing cyanide The liquid waste contains lysis reagent. Using bleach or
DNA AWAY™ Surface Decontaminant in contact with
the liquid waste container can result in a chemical
reaction producing cyanide.
r Do not use bleach or DNA AWAY™ Surface
Decontaminant to decontaminate the liquid waste
container or any part of the fluid system.
About electrical safety

Electric shock Removing the covers of electronic equipment can cause
electric shock.
r Do not remove any cover of the system except those
covers specified in the instructions.
r Keep away from areas which are marked with
electrical hazard labels.
u Safety labels on the system (30)
r Do not exchange or remove any part of the
instrument except those parts specified in the
maintenance instructions of the User Assistance.
Leave replacement or repair of all other instrument
parts to Roche Service representatives.
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About sample stability

Sample stability If a sample remains on the system for a prolonged time,
the stability of the sample material is not ensured.
Expired sample stability can occur due to rescheduling,
postponing runs, missing reagent cassettes, or missing
controls. Unstable sample material can lead to false
negative results.
r Adhere to the section about the sample stability,
defined in the Instructions for Use for the respective
sample type and test. Make sure that the time
between sample collection and sample processing is
not exceeded due to storage time.
r Include the wait time of samples caused by
rescheduling when calculating the overall sample
stability.
r For host orders, check on the Orders > Order
details screen in the Creation date/time field when
the sample was loaded. For manually created orders,
the field displays the time when the order was
created, which does not necessarily correspond to the
loading time of the sample.
About reagents and working solutions

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.
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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 Observe the instructions given in the Instructions for

Use.
r Observe the information given in the 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 a
disinfectant.
r Consult a physician.
Incorrect reagent volume Incorrect reagent handling may cause loss of reagent.
r Do not use a reagent bottle whose reagent has
spilled.
About incorrect results

Foam, clots, films, or air bubbles Insoluble contaminants, foam, fibrin clots, air bubbles, or
films in reagents or samples may cause clogging or
pipetting volume shortage, leading to incorrect results.
r Ensure sufficient centrifugation of samples to
minimize foam and clots.
Evaporation of samples If sample material is left open, it may evaporate.

r Decap samples as short as possible a time before
loading them on the system.
Incorrect results due to incorrect handling of Incorrect handling of reagents may lead to incorrect
reagents results.
r Adhere to the storage conditions defined in the
Instructions for Use for the reagents and controls. The
system does not allow the use of expired reagents.
r Do not use reagents 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 or
labels.
Incorrect results due to reuse of single-use Reuse of pipette tips, plates, or sample containers can
consumables lead to contamination, resulting in an incorrect result.
r Do not reuse single-use supplies, such as pipette tips,
plates, or sample containers.
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Incorrect results due to incorrect handling of Incorrect handling of wash reagent container, lysis
wash reagent container, lysis reagent bottle, reagent bottle, or diluent bottle may lead to incorrect
or diluent bottle results.
r Do not remove the screw cap of the bottles or
containers until they are ready for use on the
instrument.
r Open primary packaging immediately before loading.
Incorrect results due to incorrect handling of Incorrect handling of amplification plates, liquid waste
consumables plates, processing plates, and tip trays may lead to
incorrect results.
r Open primary packaging of consumables immediately
before loading.
r Check for particles before loading. If you find
particles, do not use the consumable.
r Do not use consumables that have been dropped.
r Only use consumables approved for the system.
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Caution messages
In this section
About caution messages (23)
About burns due to hot surfaces (23)
About moving parts (24)
About magnetic fields (24)
About data security (25)
About personal and confidential data (26)
About caution messages

List of caution messages
r Before operating, read the caution messages
carefully. Failure to observe them may result in minor
or moderate injury.
About burns due to hot surfaces

Hot surfaces inside Contact with some surfaces may cause burns. The
temperature of the heating station, sealing unit, and the
analytic units can reach high temperatures.
r Avoid contact with hot surfaces inside the instrument
indicated with a warning label.
r Use caution near the heating station when
performing a manual cleanup.
r Be careful if you open the cover after an instrument
error. Wait a few minutes to let the heating station
cool down before reaching into the instrument.
r If you must remove a consumable from the heating
station, wait for a least 15 minutes until the station
has cooled down.
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About moving parts

Moving parts Contact with moving parts may result in personal injury.
r Do not touch any parts of the system except those
parts specified in the maintenance chapter of the
User Assistance.
r During operation and maintenance, carefully follow
the instructions.
Processing transfer head, reagent transfer Risk of personal injury during maintenance due to the
head, sample transfer head possibility of a hand getting trapped between the
processing transfer head, the reagent transfer head, or
sample transfer head and other parts of the instrument.
r The transfer heads are heavy. Use caution when
manually moving the processing transfer head, the
reagent transfer head, or the sample transfer head
during maintenance.
About magnetic fields

Exposure to magnetic fields Close contact with the magnets at the instrument can
impact the performance of an implanted cardioverter-
defibrillator (ICD) or pacemaker. The interference can
result in a not properly functioning implanted electronic
medical device.
r If you have an implanted cardioverter-defibrillator
(ICD) or pacemaker, keep distance to areas of the
instrument that are marked with a magnetic hazard
label.
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About data security

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 the security.
r Always enter your password unobserved.
r Do not write down your password anywhere,

including in a contact form, in an address book, or in
a file on the computer.
r Do not disclose your password to anyone. Roche
never asks you for your password.
r If you ever disclose your password to anyone, change
it immediately afterwards.
r u For information on how to change the password,

see the x800 Data Manager user documentation.
r Contact your local Roche affiliate if you think your
account has been compromised.
Data loss, unavailability of the system, or Infection by malicious software or misuse of the system
unauthorized access to personal information can result in data loss, unavailability of the system, or
due to malicious software or misuse unauthorized access to personal information.
r Do not install and/or run any other software on the
system.
r Ensure networks are secure and monitored.
Customers are responsible for the security of their
local network, especially for protecting it from
malicious software and cyberattacks. This protection
includes measures such as Roche Fortigate to
separate the device from uncontrolled networks.
r Ensure other computers and services on the network
are properly secured and protected against malicious
software and unauthorized access.
r Restrict physical access to the system and all
attached IT infrastructure (computer, cables, network
equipment, etc.).
r Ensure that any external storage devices (such as
USB flash drives, network file systems) connected to
the system are free of malicious software.
r The use of the Roche-provided hardware firewall is
mandatory.
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Disclosure of confidential data Unauthorized access can result in data loss,

unavailability of the system, or unauthorized access to
personal information.
equipment, etc.).
r Ensure that files on any external storage devices
(such as USB flash drives) are protected against
unauthorized access.
r Set a short auto logoff timeout on the system (for
example, keep the default value of 10 minutes).
r Prevent credential theft:
• Use strong passwords.
• Do not share passwords.
• Do not write down passwords.
• Do not share user accounts.
r Ensure that export, backup and archive files are
stored in a secure location and are protected from
any unauthorized access and disaster.
About personal and confidential data

The data manager saves the user ID, sample ID,
diagnostic results, and the audit trail in the database.
Additionally, the data manager and the instrument save
the user ID, sample ID, and diagnostic results in a
problem report.
Optionally, in the user management interface of the data

manager you can save the first and last names of the
user. You can only delete this information manually.
Uploading non-cleansed data to Roche may expose

sensitive data (such as user ID, sample ID, diagnostic
results). For automatic upload, do not change the
preselected data cleansing in the settings on the
instrument or the data manager.
If you back up stored information on an external device

or local network, you are responsible for the security of
the external device or local network.
Roche Diagnostics
27
Disclosure of confidential data due to entry in The instrument and data manager can operate with only
open text fields a sample ID identifying the test order and associated
result. The instrument and data manager provide open
text fields that can leverage additional LIS-provided or
operator-entered information. Adding patient personal
health information to open text fields increases the risk
of privacy incidents and exposure to sensitive data.
r Do not enter any confidential patient-related
information into the comment field of the Orders app
or Results app. There is the risk of unauthorized
access to patient data.
r Do not use sensitive data like patient identifiers or a
social security number as a sample ID.
equipment, etc.).
Disclosure of confidential data because the Any data not requested in the order query can be
host returns patient information recorded in a communication log file.
r Set up an external system so that it does not return
patient information in addition to the data requested.
equipment, etc.).
Roche Diagnostics
28
Notices
In this section
About notices (28)
About spillage (28)
About circuit breakers and fuses (29)
About mechanical stress (29)
About out-of-range temperature (29)
About notices
List of notices
Failure to observe the notices may result in damage to

the system.
r Before operating the system, read the notices
carefully.
About spillage
Spilled liquid Any liquid spilled on the system may result in
malfunction or damage.
r Check the integrity of all consumables’ packaging
before unpacking them.
r Place samples, reagents, or any other liquid only in
the intended positions.
Do not place samples, reagents, or any other liquid on
the drawers or other surfaces of the system.
r When you remove consumables during the cleanup of

the deck, 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. If the spillage flows
into the system, for example, through the heating
station, call your Roche Service representative.
r Dispose of waste according to the local regulations.
Roche Diagnostics
29
Incorrect results due to overfilling the sample Overfilling the sample containers can lead to spillage
containers during normal operation and result in contamination and
incorrect results.
r Do not overfill sample containers. The fill volume
specified by the sample container manufacturer must
not be exceeded.
About circuit breakers and fuses

Circuit breakers and fuses Improper use may result in damage to the system.
r If a circuit breaker trips or a fuse blows, contact your
About mechanical stress

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 top of the system.
About out-of-range temperature

Loss of reagents and processing samples due Exposure to heat may cause the temperature inside the
to out-of-range temperature instrument to rise. If the temperature in the processing
area of the instrument is > 37 °C, all ongoing runs are
aborted (except for those in PCR), and all bulk reagents
are invalidated. If the temperature in the reagent supply
or control mini rack drawer is > 37 °C, the ongoing runs
are aborted (except for those in PCR), and the reagent
cassettes or control mini racks are invalidated. If the
temperature in the processing area of the instrument is
< 15 °C, all ongoing runs are aborted (except for those
in PCR).
r Avoid putting heat sources close to the instrument.
r Run the instrument in a temperature-controlled

environment.
u See the system specifications in the user documentation

for the allowable environmental conditions.
Roche Diagnostics
30
Safety labels on the system

In this section
About safety labels on the system (30)
List of safety labels on the system (30)
About the location of safety labels on the system (31)
About safety labels on the system

The system has warning labels to draw your attention to
areas of potential hazard. The following list explains the
meanings of the labels at the locations where you find
the labels.
The safety labels on the system comply with the following

standards: ANSI Z535, IEC 61010-2-101, IEC 61010-1, or
ISO 15223-1.
i Only Roche Service representatives may replace

damaged labels. For replacement labels, contact
your Roche Service representative.
List of safety labels on the system

General warning
Potential hazards located near this label may lead to

death or serious injury.
Refer to the manual for instructions on safe operation.
Biohazard
Potentially biohazardous materials are used near this

label.
Observe relevant laboratory procedures on safe usage.
Hot surface
The area near this label may be hot.
To avoid burns, do not touch this area.
Roche Diagnostics
31
Strong magnetic field
Parts of the instrument marked with this label contain

strong magnetic fields.
Avoid exposure.
i 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.
About the location of safety labels on the system

Safety labels on the drawers
w Safety label on the amplification plate drawer
Roche Diagnostics
32
w Safety label on the control mini rack drawer
w Safety labels on the reagent cassette drawers
Roche Diagnostics
33
w Safety label on the liquid waste drawer
w Safety label on the solid waste drawer
Roche Diagnostics
34
w Safety label in the solid waste compartment
Safety labels on the sample loading area
w Safety labels on the sample loading area
Roche Diagnostics
35
w Safety label on the closed sample loading area door
w Safety label on the open sample loading area door
Roche Diagnostics
36
Safety labels on the deck
w Safety label on the solid waste chute
w Safety labels on the processing unit
Roche Diagnostics
37
w Safety label on the camera of the sample loading area
w Safety labels on the sealing unit and the analytic units
Roche Diagnostics
38
w Safety label on the control mini rack sliding cover
Safety labels on the monitor
w Safety label on the front of the monitor
Roche Diagnostics
39
w Safety label on the back of the monitor
Safety labels on the flaps
w Safety label on the small dust filter flap
Roche Diagnostics
40
w Safety labels on the large dust filter flaps
w Safety labels on the external connection ports flap
Roche Diagnostics
41
About substances according to REACH

This product includes internal constituents containing a
Substance of Very High Concern (SVHC) as identified
under the Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH) regulation of the
European Union. The substances are listed on the
Candidate List in accordance with the REACH regulation:
• Lead (CAS 7439-92-1), in a concentration above 0.1%
weight by weight
• Cyclohexane-1,2-dicarboxylic anhydride (CAS
85-42-7), in a concentration above 0.1% weight by
weight
• 4,4'-isopropylidenediphenol (CAS 80-05-7), in a
concentration above 0.1% weight by weight
• Diboron trioxide (CAS 1303-86-2), in in a
concentration above 0.1% weight by weight
Roche Diagnostics
42
Safety information for disposal

Infection by biohazardous material r Treat the system as biohazardous waste. Follow the
decontamination procedure before reuse, recycling,
or disposal of the system.
r Dispose of the system according to the local
regulations. For more information, contact your Roche
Service representative.
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 classified as contaminated or not. If contaminated,
treat them in the same way as the system.
Roche Diagnostics
Page intentionally left blank.
Published by:
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.roche.com

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cobas® 5800 System

Publication version Software version Revision date Change description

1.0 1.0 May 2021 First edition

u About personal and confidential data (26)

u About incorrect results (21)

Edition notice This publication is intended for users of the

Every effort has been made to ensure that all the

The Safety Guide contains important safety information.

The User Guide focuses on routine operation and

The Quick Reference Guide gives a brief introduction

The Host Interface Manual provides references for

To avoid serious or fatal injury, ensure that you are

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

Training Do not carry out operation tasks or maintenance actions

Images The screenshots and hardware images in this publication

Warranty Any customer modification to the system renders the

For conditions of warranty, contact your local sales

Always perform software updates in accordance with the

Copyright © 2023, F. Hoffmann-La Roche Ltd. All rights reserved.

License information The cobas® 5800 System software is protected by

This open-source and commercial software and

Note that the respective authorization is no longer valid

Trademarks The following trademarks are acknowledged:

COBAS and COBAS OMNI are trademarks of Roche.

All other trademarks are the property of their respective

Feedback Every effort has been made to ensure that this

Approvals The cobas® 5800 System meets the requirements laid

Regulation (EU) 2017/746 of the European Parliament

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

Directive 2014/53/EU of the European Parliament and of

Compliance with the applicable directives is provided by

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

Issued by CSA Group for Canada and the US.

Issued by the TÜV SÜD for Canada and the US.

'Laboratory Equipment' is the product identifier as

Roche Molecular Systems, Inc.

Roche Diagnostics GmbH

Distributed in the United States by:

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

eLabDoc Electronic user documentation can be downloaded using

For more information, contact your local affiliate or

Page intentionally left blank.

The cobas® 5800 System supports an automated and

Product names, symbols, and abbreviations

Product names Product name Descriptor

cobas® 5800 System System

Symbols used in the publication Symbol Explanation

u Cross-reference to another topic

w Figure, used in figure titles and cross-

y Table, used in table titles and cross-

q Tip, used for extra information on correct use

I Extra information within a task

f Result of an action within a task

d Materials that are required for a task

y Symbols used in the publication

Symbols used on the product Symbol Explanation

Global Trade Item Number

Disposal of control unit

Unique device identifier

Indicates the entity importing

Indicates the entity distributing