Roche cobas p 480 v2 is a fully automated pre-analytic system that simplifies and streamlines laboratory processes. It features decapping and recapping, pipetting, specimen mixing, aliquoting, heating/cooling, and more, with the capacity to process up to 500 samples per hour in random access mode. The instrument's user-friendly interface and comprehensive software provide flexibility and control over the entire pre-analytic workflow.
Roche cobas p 480 v2 is a fully automated pre-analytic system that simplifies and streamlines laboratory processes. It features decapping and recapping, pipetting, specimen mixing, aliquoting, heating/cooling, and more, with the capacity to process up to 500 samples per hour in random access mode. The instrument's user-friendly interface and comprehensive software provide flexibility and control over the entire pre-analytic workflow.
cobas p 480 v2 instrument
Safety Manual
Version 1.1
Software version 2.1.1
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
2
Publication information
Edition notice This publication is for users of the cobas p 480 v2
instrument.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of printing. However, Roche Diagnostics Ltd.
reserves the right to make any changes necessary
without notice as part of ongoing product development.
Copyright © 2014–2020, F. Hoffmann-La Roche Ltd. All rights
reserved.
Contact addresses
Publication version Software version Revision date Change description
1.0 2.1.1 March 2017 First version
1.1 2.1.1 January 2020 u What is new in publication version 1.1 (6)
y Revision history
cobas p 480 v2 instrument
Made in Switzerland by Hamilton Bonaduz AG for
Roche Molecular Systems, Inc.
1080 US Highway 202 South
Branchburg, NJ 08876
USA
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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T
able of contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Conventions used in this publication. . . . . . . . . . . 5
What is new in publication version 1.1 . . . . . . . . . 6
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
About operator qualification . . . . . . . . . . . . . . . . . . 9
About safe and proper use of the instrument . . . 9
Miscellaneous safety precautions overview . . . . . 11
Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 14
Optical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Burns due to hot surfaces . . . . . . . . . . . . . . . . . . . . 17
Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Collection media and other working solutions . . . 18
Fatigue due to long hours of operation . . . . . . . . . 19
Electromagnetic interference . . . . . . . . . . . . . . . . . 19
IT security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Circuit breakers and fuses . . . . . . . . . . . . . . . . . . . 21
Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Safety labels on the instrument . . . . . . . . . . . . . . . . . . 22
Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 25
Safety information for disposal. . . . . . . . . . . . . . . . . . . 26
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
4 Preface
Preface
Use this publication together with the instrument
Operator’s Manual.
Operation and maintenance actions are described in the
Operator’s Manual.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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Intended use
The cobas p 480 instrument is a stand-alone general
purpose laboratory instrument to minimize repetitive
manual tasks associated with specimen handling. This
instrument is intended to perform pre-analytics
processing such as decapping and recapping, pipette-
and spin-mixing specimens, and aliquoting specimens to
secondary vials. Additional hardware components and
programing flexibility allow automation of more complex
pre-analytic processes including reagent addition and
heating.
Conventions used in this publication
Product names Except where the context clearly indicated otherwise, the
following product names and abbreviations are used.
Abbreviations The following abbreviations are used.
Product name Abbreviation
cobas p 480 instrument instrument
cobas p 480 software software
y Product names
Abbreviation Definition
ANSI American National Standards Institute
EC European Community
EN European standard
ID Identification number
IEC International Electrical Commission
LED Light-emitting diode
max. Maximum
min. Minimum
SOP Standard Operating Procedure
y Abbreviations
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
6 Preface
What is new in publication version 1.1
Electric safety Information added to connect the instrument only to an
earth-grounded outlet and to replace a damaged power
cable immediately.
u Electrical safety (13)
Relocation and transportation Heading of safety precaution about relocation changed.
u Miscellaneous safety precautions overview (11)
Laser safety Year of Issue added to standard IEC 60825-1.
u Safety information for lasers (25)
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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Introduction
!
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the instrument and safety information 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 Store all publications in a safe and easily retrievable
place.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
8 Safety classifications
Safety classifications
The safety precautions and important user notes are
classified according to the ANSI Z535.6-2011 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
instrument, 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 instrument.
Important information that is not safety relevant is
indicated with the following icon:
q Tip...
...indicates additional information on correct use or useful
tips.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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Safety precautions
!
To avoid serious or fatal injury, read and
comply with the following safety precautions.
In this section
About operator qualification (9)
About safe and proper use of the instrument (9)
Miscellaneous safety precautions overview (11)
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 the Operator’s Manual.
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.
About safe and proper use of the instrument
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 lab 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).
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
10 Safety precautions
Exposure to chemicals r Avoid exposure to chemicals.
Regular cleaning To prevent inaccurate results and unsafe operation of the
instrument:
r Regularly clean and/or decontaminate the instrument
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.
Errors in installation Only trained Roche Service representatives may install
the instrument.
r Leave installation that is not described to trained
Roche Service representatives.
Exchange or removal of parts Unauthorized exchange or removal of instrument parts
can damage the instrument or stop it from functioning
correctly.
r Do not exchange or remove any part of the
instrument.
r Leave replacement of instrument parts to trained
Roche Service representatives.
Unsuitable environmental conditions Operation outside of the specified ranges may lead to
incorrect results or malfunction of the instrument.
r Use the instrument indoors only, and avoid heat and
humidity outside of the specified range.
r Make sure that the instrument's ventilation openings
always remain unobstructed.
r To maintain the environmental conditions of the
instrument, 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
Operator’s Manual.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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Non-approved spare parts Use of non-approved spare parts or devices may result in
malfunction of the instrument 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.
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 instrument.
u For a list of supported materials, see the Operator’s
Manual.
Miscellaneous safety precautions overview
Power interruption A power failure or momentary drop in voltage may
damage the instrument 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.
Electromagnetic compatibility The instrument complies with the emission and immunity
requirements described in this part of the
IEC 61326–2–6: 2012 series.
The instrument complies with the emission requirements
described in this part of the FCC CFR 47, Part 15 Class A.
Instrument not used for an extended period r Set the power switch to OFF if you do not use the
instrument for an extended period.
r For further information, call your Roche Service
representative.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
12 Safety precautions
Relocation and transportation r Do not attempt to relocate or transport the instrument.
r Leave relocation and transportation to Roche Service
representatives.
u Related topics
• Safety information for disposal (26)
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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Warning messages
!
List of warning messages
Failure to observe warning messages may result in death
or serious injury.
r Before operating the instrument, read the warning
messages carefully.
In this section
Electrical safety (13)
Biohazardous materials (14)
Optical safety (15)
Waste (16)
Electrical safety
Electric shock Removing the covers or panels of electronic equipment
can cause electric shock because there are high-voltage
parts inside. Connecting the instrument to an
ungrounded power source can cause electric shock.
r Do not attempt to work on any electronic equipment.
r Do not remove any cover or panel of the instrument.
r Only Roche Service representatives may install,
service, and repair the instrument.
r Directly connect the instrument to an approved earth-
grounded power source such as a three-wire
grounded receptacle for the 115/230 V line. Do not
use an extension.
r If the power cable becomes cracked, frayed, broken,
or otherwise damaged, replace it immediately with an
equivalent part.
u Related topics
• Safety labels on the instrument (22)
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
14 Warning messages
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 instrument is
operating.
r Do not open the solid waste door during operation.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply a disinfectant.
r If sample material or waste comes into contact with
your skin, wash the affected area immediately with
soap and water and apply a disinfectant.
Consult a physician.
Operator infection and injury Contact with instrument mechanisms (for example,
grippers, pipetting channels, autoloader, etc.) or with the
instrument chassis or covers may result in personal injury
and infection.
r Whenever possible, keep the covers of the instrument
closed.
r Always ensure that the instrument is off or in
Maintenance status, before you work with an
opened cover (for example, for cleaning or
maintenance).
r Be careful not to hit your head when the covers are
open.
r Do not touch any parts of the instrument other than
those specified.
r Never reach into the instrument while parts are
moving.
r Carefully observe all instructions given in this
publication and in the user documentation.
Sharp objects Contact with needles or sharp disposables may result in
infection.
r When cleaning near the needles, 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.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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Smoke due to electrical malfunction Electrical malfunction can result in the emission of
hazardous smoke. Inhaling smoke emitting from the
instrument can lead to personal injury.
r If you see smoke coming from the instrument:
o Avoid inhaling
o Disconnect from power supply
o Contact Roche Service immediately
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.
Optical safety
Blindness due to intense barcode reader light The intense light of a laser or LED barcode reader may
severely damage your eyes or result in exposure to
hazardous radiation.
r Do not stare into the beam of a laser or LED barcode
reader.
r Do not remove the housing from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche Service representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
16 Warning messages
Waste
Infectious waste Contact with solid waste may result in infection. All
materials and mechanical components associated with
the solid 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 a disinfectant.
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.
Environmental harm The instrument generates liquid and/or solid waste.
Liquid waste contains concentrated reagents, 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.
u Related topics
• Safety labels on the instrument (22)
• Safety information for disposal (26)
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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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.
In this section
Burns due to hot surfaces (17)
Mechanical safety (17)
Collection media and other working solutions (18)
Fatigue due to long hours of operation (19)
Electromagnetic interference (19)
IT security (20)
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
120 °C.
r Avoid contact with hot surfaces inside the instrument
indicated with a warning label.
r Use caution near the heating station following an
emergency stop.
r Be careful if you open the instrument covers after an
instrument error. Wait a few minutes to let the heating
station cool down before reaching into the instrument.
Mechanical safety
Damaged touch screen monitor Damage to the touch screen monitor can expose sharp
edges, which can cause personal injury if touched.
r Avoid touching the touch screen monitor if it is visibly
damaged.
r Contact your Roche Service representative.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
18 Caution messages
Moving parts Contact with moving parts may result in personal injury.
r Keep all covers closed and in place while the
instrument is operating. A safety interlock system
prevents the opening of covers during operation.
r Always ensure that the instrument is off or in
Maintenance status, before you work with an
opened cover (for example, for cleaning or
maintenance).
r Do not remove any carrier from the instrument deck
during operation.
r Do not touch any parts of the instrument except those
parts specified. Keep away from moving parts during
operation.
r During operation and maintenance, carefully follow
the instructions.
u Related topics
• Safety labels on the instrument (22)
Collection media and other working solutions
Skin inflammation or injury Direct contact with collection media, cleaning solutions,
or other working solutions may cause skin irritation,
inflammation, or burns.
r When you handle collection media or cleaning
solutions, exercise the precautions required for
handling laboratory solutions.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Instructions for
Use for the collection media.
r Observe the information given in Material Safety Data
Sheets (available for Roche Diagnostics reagents and
cleaning solutions).
r If collection media or cleaning solutions come into
contact with your skin, wash the affected area
immediately with soap and water and apply a
disinfectant.
Consult a physician.
Foam, clots, films, or bubbles Incorrect results may occur due to foam, fibrin clots, films,
or bubbles in samples.
r Ensure good sample preparation and collection media
handling techniques to avoid the formation of foam,
clots, and bubbles.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
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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 collection media Evaporation of samples or collection media 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 collection media. Ensure
that collection media are stored according to the
Instructions for Use.
Incorrect results due to reuse of container
caps
Reuse of caps for containers and tubes can lead to
contamination, resulting in an incorrect result.
r Do not reuse caps.
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
instrument and incorrect results.
r Do not use this instrument near sources of strong
electromagnetic fields because these fields can
interfere with the proper operation.
r Evaluate the electromagnetic environment before you
operate the instrument.
r Take measures to mitigate the interference.
Roche Diagnostics
cobas p 480 v2 instrument · Software version 2.1.1 · Safety Manual · Version 1.1
20 Caution messages
Wireless interference Wireless devices in the instrument may lead to
malfunction.
r Do not leave mobile phones or other wireless devices
inside the instrument.
IT security
Data loss, unavailability of the instrument, or
damage to the instrument due to malicious
software or unauthorized system access
Malicious software or unauthorized system access can
result in data loss, instrument unavailability, or damage to
the instrument.
To avoid infection by malicious software or the
unauthorized access and misuse of the instrument, the
following recommendations are essential:
r Do not connect any external storage devices (such as
USB flash drives or external hard drives) to the
instrument.
r Do not install and/or execute any other software on
the instrument.
r Make sure other computers and services on the
network (for example, the LIS, archiving share, backup
share, or service) are properly secured and protected
against malicious software and unauthorized access.
r Customers are responsible for the security of their
local area network, especially in protecting it against
malicious software and attacks. This protection might
include measures, such as a firewall, to separate the
device from uncontrolled networks as well as
measures that ensure that the connected network is
free of malicious code.
r The Roche-provided firewall is mandatory and part of
the instrument.
r Restrict physical access to the instrument and all
attached IT infrastructure (computer, cables, network
equipment, etc.).
r Make sure that system backup and archive files are
protected from any unauthorized access and disaster,
this includes: remote storage location; disaster
discovery sites; secure transfer of backup files.
r Prevent credential theft.
o Use strong passwords.
o Do not share passwords.
o Do not write passwords down.
o Do not use the same credentials on multiple
instruments.
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Roche cobas p 480 v2 is a fully automated pre-analytic system that simplifies and streamlines laboratory processes. It features decapping and recapping, pipetting, specimen mixing, aliquoting, heating/cooling, and more, with the capacity to process up to 500 samples per hour in random access mode. The instrument's user-friendly interface and comprehensive software provide flexibility and control over the entire pre-analytic workflow.
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