2. Roche
  3. COBAS INTEGRA 400 plus
COBAS INTEGRA 400 plus

Roche COBAS INTEGRA 400 plus User manual

  • Hello! I am an AI chatbot trained to assist you with the Roche COBAS INTEGRA 400 plus User manual. I’ve already reviewed the document and can help you find the information you need or explain it in simple terms. Just ask your questions, and providing more details will help me assist you more effectively!
User Manual
Software Version 3.5
User Manual Version 2.8, 2.9, and 2.9.1
Review the section "Revisions" at the end of this
document for new information and changes to
previous editions.
ii User Manual · Version 2.7
Revision history
Publication notice
This publication is for users of the COBAS INTEGRA
®
400 plus analyzer.
Every effort has been made to ensure that all the information contained in this
publication is correct at the time of publishing. However, Roche Diagnostics GmbH
reserves the right to make any changes necessary without notice as part of ongoing
product developments and improvements.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Intended use The COBAS INTEGRA 400 plus analyzer is a fully automated, computerized chemistry
analyzer. It is intended for in vitro quantitative or qualitative determination of a wide
range of analytes in various body fluids.
Copyrights © 1998-2013, Roche Diagnostics International Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:
Acrobat, Windows, Windows XP.
COBAS and COBAS INTEGRA are registered trademarks of a member of the Roche
group.
Manual
version
Software
version
Revision date Changes
1.0 November 1998
1.1 April 1999
2.0 December 2000
2.1 June 2001
2.2 October 2002
2.3 August 2004
2.4 3.4 (Windows XP) July 2006 Slight content changes due to new
software version
2.5 3.5 June 2009 Minor content changes due to new
software version
2.5 3.5 September 2012 Updated laser information
2.6 3.5 April 2013 Diluents handling, purge, internet
connection disclaimer
2.7 3.5 September 2013 Hardware specifications, data handling via
USB
User Manual · Version 2.7 iii
Instrument approvals The instrument meets the protection requirements laid down in Directive 98/79/EC of
the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic
medical devices. Compliance is provided by means of the Declaration of Conformity.
Regulatory compliance is demonstrated by the following marks:
Contact address
Complies with European Union (EU) Directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the
US.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
iv User Manual · Version 2.7
User Manual · Version 2.7 v
Table of contents
Table of contents v
Preface ix
Software virus warning xviii
Safety labels on the system xx
Safety information for laser transmitters xxi
Overview Part A
1 System overview
Introduction A-4
A first look at a COBAS INTEGRA 400 plus
analyzer A-5
Overview of user tasks A-8
Basic principles A-10
2 System description
Panels and logos A-16
Modules and main components A-18
Functional systems A-19
System states A-42
3 User interface
A first look at the user interface A-46
Work areas A-47
Working with the user interface A-49
Tips and techniques A-51
4 Online Help
Introduction A-54
Starting and closing online Help A-55
Help window A-56
Finding information A-60
Context Help A-63
General Help A-65
Message Help A-66
Related topics A-68
Glossary A-69
Accessing additional information in Acrobat A-70
Operation Part B
5 Daily workflow
Introduction B-5
Daily start-up B-8
Daily routine (without sample barcode and without
host) B-13
Daily routine (with sample barcode and without
host) B-19
Daily routine (with sample barcode and with host)
B-25
End of day B-30
6 Routine tasks
Starting up and logging on to the system B-35
Logging off and shutting down the system B-39
(Re)Starting and stopping a run B-41
Handling test materials B-42
Managing resources B-48
Checking due service actions B-56
Checking the Memo Pad B-57
Printing reports B-58
Purging and deleting information and items B-67
Archiving system information B-70
7 Status
About Status B-72
Status work area overview B-73
Missing & Blocked tab B-74
Samples tab B-76
Cassettes tab B-78
Test Status tab B-80
Analyzer tab B-82
ISE tab B-84
Displaying item details B-86
Selected tasks B-88
8 Orders
About orders B-90
Orders at a glance B-91
Orders work area B-93
Worklist tab B-95
Sample tab B-97
Calibration tab B-99
Quality Control tab B-100
Creating an order B-101
Working with Orders B-110
9 Results
About results B-120
Results work area overview B-123
Validate tab B-124
Sample tab B-127
Calibration tab B-129
Quality Control tab B-130
Selecting specific patients and orders B-132
Displaying detailed information B-134
Working with results B-137
vi User Manual · Version 2.7
10 Calibration
About calibration B-146
Calibrations at a glance B-149
Reviewing the status of calibrators on board B-151
Loading calibrators on board B-154
Requesting calibrations B-156
Postponing a calibration B-158
Validating calibration results B-160
Setting up calibrators B-165
11 Quality controls
About controls B-172
Controls at a glance B-174
Reviewing the status of controls on board B-176
Loading controls on board B-179
Requesting controls B-180
Reviewing and validating control results B-182
Setting up controls B-192
Flags Part C
12 Result flags
About result flags C-5
Flags and recommended actions C-6
Service Part D
13 Service action software
About service actions D-4
Service work area overview D-5
Due tab D-6
All tab D-7
Begin of Day tab D-8
Performing a service action D-10
Service notes D-12
Counters and timers D-14
14 Service actions
Deproteinize probes D-21
Clean probes and splash guard D-22
Clean internal water reservoir D-25
Clean wash station D-28
Clean external water reservoir and fluid waste
reservoir D-31
Clean instrument D-34
Clean the waste box fitting D-40
Clean and lubricate the rotor D-41
Prime the fluid system D-44
Roche service D-45
Backup database D-46
Replace ventilation filter D-47
Replace Abs. halogen lamp D-49
Replace probe B (or C) D-52
Replace plunger tip dosage pipette B (or C) D-55
Replace dosage pipette B (or C) D-59
Replace external water reservoir filter D-62
Managing data D-63
Troubleshooting Part E
15 Messages
About messages E-4
New Messages tab E-6
Message Log tab E-7
Options tab E-8
Working with messages E-9
Putting the system into Standby E-11
Stopping and restarting the system E-12
16 Troubleshooting
Introduction E-17
Start-up problems E-18
Blocked orders, tests, calibrations, or controls E-19
Results E-26
Hardware E-29
Software error messages E-34
Data station accessories E-35
External connectors E-37
Checking and replacing fuses E-40
Contacting Roche Service E-44
ISE measurements Part F
17 ISE module
Overview F-4
How the ISE module works F-8
Making ISE measurements F-11
ISE solutions summary F-12
Technical specifications F-12
18 ISE service actions
About ISE service actions F-14
Initialize ISE module F-15
Electrode service F-16
Activate electrodes F-17
Prime ISE calibrators F-18
Clean ISE tower automatically F-19
Clean ISE tower manually F-20
Replace ISE module tubing F-23
Replace electrode F-25
Condition ISE tubing F-29
Replace ISE solutions on the ISE rack F-30
Replace bottles on ISE module F-32
Replace ISE tower F-34
ISE Performance Check F-35
19 ISE flags and troubleshooting
About ISE flags F-38
Flags and user actions F-39
Flag descriptions F-41
General ISE troubleshooting F-47
User Manual · Version 2.7 vii
Configuration Part G
20 Configuration
Configuration overview G-4
About the Definitions group G-6
Loading test application software G-18
Archiving and reloading definitions G-20
System group G-21
Windows group G-23
Appendix Part H
21 Appendix
Technical specifications H-4
Fluid system schematic H-12
Keyboard shortcuts H-13
Menu structure H-14
Glossary and Index Part I
Glossary I-3
Index I-9
Revisions Part J
viii User Manual · Version 2.7
User Manual · Version 2.7 ix
Preface
This manual refers specifically to the COBAS INTEGRA 400 plus analyzer and
software version 3.5 (Windows XP). It is intended for users of the instrument and
software.
About the COBAS INTEGRA 400 plus analyzer
The COBAS INTEGRA 400 plus analyzer is an advanced integrated system for
diagnostic clinical chemistry testing.
Classical chemistry, electrolytes, specific proteins, therapeutic drug monitoring, drugs
of abuse, and thyroid hormone testing are consolidated into one system with one
reagent cassette design.
Random sample access, innovative robotics, and an advanced user interface, using
Windows XP, optimize time management and streamline workflow.
The Ion Selective Electrode (ISE) module allows the determination of sodium,
potassium, chloride, and lithium ions in parallel with absorbance- and FP
photometric measurements.
Reagent cassettes, samples, calibrators, and controls are identified by a barcode
scanner.
The high performance, flexibility, and versatility of the COBAS INTEGRA 400 plus
analyzer make this system suitable as a routine and a STAT analyzer as well as a
dedicated instrument for specific tasks.
A Data station
B Instrument
A B
R
o
c
h
e
x User Manual · Version 2.7
How to use this manual
This manual is designed to help you perform all of the tasks that are required as part of
your work with the INTEGRA 400 plus analyzer.
If you are a new user, the manual will also help you to understand general hardware
principles, the user interface, the status of the instrument and its modules. You should
familiarize yourself with these areas before attempting to perform daily tasks.
You can also find information about how to use the COBAS INTEGRA 400 plus
analyzer in the COBAS INTEGRA 400 plus Short Guide and in the Online Help.
Content The manual is divided into the following parts:
o Part A - Overview: Contains general information about the COBAS INTEGRA 400
plus analyzer, about the basic concepts of using the instrument, the hardware, the
software, and the online Help.
o Part B - Operation: Starts with a workflow description for some typical laboratory
setups, using step-by-step instructions. It then describes how to perform all the
day-to-day tasks necessary to create orders, monitor the status of the instrument,
view results, and deal with some simple problems that do not require detailed
analysis.
o Part C - Flags: Describes the flags that are generated for unaccepted results and
gives recommended actions.
o Part D - Service: Describes how to start and perform service actions that are
essential to maintain maximum productivity from this instrument.
o Part E - Troubleshooting: Describes how to pinpoint potential problems and how
to solve them.
o Part F - ISE measurements: Describes the principles of operation of the ISE
module and contains specialized sections on ISE flags and troubleshooting, and
ISE service actions.
o Part G - Configuration: Describes some of the most common configuration tasks
for a fully operational system. Full details on all configuration procedures are
given in the online Help.
o Appendix: Contains additional information including a technical specification of
the instrument.
o Glossary and index: Provides reference and look-up material.
Other COBAS INTEGRA 400 plus publications
Additional publications relating to the COBAS INTEGRA 400 plus analyzer are also
available:
Data Analysis This publication describes the calculation, calibration, and control modes for
absorbance, FP, and ISE measurements, as well as the quality control methods and
checks.
Method Sheet A detailed guide to the COBAS INTEGRA reagents, including test definitions and
performance data.
Short Guide A short-form manual containing step-by-step information on the most commonly
used tasks.
User Manual · Version 2.7 xi
Conventions used in the COBAS INTEGRA 400 plus documentation
This section describes the conventions used in this manual, including symbols, user-
interface conventions, and units.
Symbols The following symbols are used:
User interface
conventions
The following conventions are used throughout the user documentation:
Symbol Used for
a Step-by-step procedure
Cross reference
m Checklist
i Notes
User action Meaning
Configuration / Tests / ID
1 Click Configuration in the navigation bar.
2 Double-click Tests in the Definitions
group.
3 Click the ID tab.
Choose File > Print Report > BOD Report
1 Click File in the menu bar.
2 Select Print Report from the menu.
3 Select BOD Report from the next menu.
Shift + F3 Press the Shift key and hold it down; press
and release the F3 function key; then release
the Shift key.
Click Press the left button on the mouse or the
equivalent button on the system keyboard.
Click OK Move the cursor to the OK button, and then
press the left mouse button.
Click Status Click the Status button on the navigation bar.
Click Print Click the Print button in the current window
or dialog box.
Right-click Click the right mouse button (or equivalent
on the keyboard).
Press Press a key on the keyboard.
Double-click Click the left mouse button (or equivalent on
the keyboard) twice in rapid succession.
Open Open the window or dialog box.
Close Close the window or dialog box.
xii User Manual · Version 2.7
Units SI units (Système International d’Unités) are used throughout the manual, where
appropriate. The following units are either non-SI or may be unfamiliar to some users:
Abbreviations and acronyms
The following abbreviations and acronyms are used throughout the documentation.
Abbreviation Unit
BTU British thermal unit
cm Centimeters
in Inches
lb. Pounds (weight)
M Megaohm
psi Pounds per square inch
VA Volt-Amperes
VAC Volts (alternating current)
S Microsiemens
Abbreviation Meaning Usage
abs. absorbance abs. measurement
BOD Begin of Day BOD service action
CAL calibrator (legend on graphic)
DIL diluent (legend on graphic)
FP Fluorescence Polarization FP photometer
ID Identification (number) User ID, patient ID
in. internal in. water reservoir
ISE Ion Selective Electrode ISE module
LCD Liquid crystal device LCD monitor
LED Light-emitting diode LED status indicator
No. number Lot No.
STAT immediate order Priority samples, tests and results
TAS Test Application Software Roche default test, calibration,
control, and diluent definitions
User Manual · Version 2.7 xiii
Safety classifications
The safety precautions and important user notes are classified according to the
following description. Before you attempt to use the COBAS INTEGRA 400 plus
analyzer, you must be fully familiar with the following symbols and their meanings:
Safety information
Before operating the COBAS INTEGRA 400 plus analyzer, it is essential that you both
read and understand the safety information listed below.
Read all Roche safety notices carefully and make sure you understand them.
Indicates a direct danger that, if not avoided, may result in death or serious injury.
Indicates a possibly hazardous situation that, if not avoided, may result in death or serious injury.
Indicates a possibly hazardous situation that, if not avoided, may result in slight or minor injury
or may result in damage to equipment.
Electrical safety
Danger of electric shock when touching power supply components. Never attempt to access
any parts of the instrument other than those specifically described in the user documentation. In
particular, never open or manipulate any components on the rear of the instrument.
Electrical safety
Before removing main cover disconnect mains plug from socket. Hazardous voltage is present
on ISE power supply even if main switch is off. Danger of electric shock when touching power
supply components.
Biological safety
Samples analyzed with this instrument may contain potentially infectious material. Samples
derived from humans, animals, tissue culture, or in vitro cultures should be handled and
processed with appropriate safety precautions. Such samples may contain bacterial, fungal or
viral agents. Spills should be immediately disinfected with an approved disinfectant solution to
avoid contamination of laboratory personnel and equipment.
xiv User Manual · Version 2.7
Loss of sight due to staring into laser beam
Barcode scanner contains a class 2 laser diode.
Do not stare into the laser transmitter beam as your eyesight may be severely damaged.
For position of the laser transmitters, see "Safety information for laser transmitters" on page xxi.
Danger of explosion
Danger of explosion through sparks. Keep all potentially inflammable or explosive material (for
example anesthetic gas) away from the instrument.
Fire risk
Spraying liquid on the power supply parts can cause a short circuit and result in a fire. Keep the
cover closed while the instrument is connected to the main power supply and do not use sprays
in the vicinity of the COBAS INTEGRA 400 plus analyzer.
During fire-fighting operations disconnect the COBAS INTEGRA 400 plus analyzer from the
main power supply.
Instrument in use
Danger of injury to hands by moving parts. Keep the instrument cover closed while initialization
or measuring is in progress.
Malfunction of instrument and incorrect results due to interfering
electromagnetic fields
Devices that emit electromagnetic waves may cause the instrument to malfunction. Do not use
this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded
intentional RF sources), as these can interfere with the proper operation.
Sample
Danger of infectious sample material which can cause severe illness. Avoid direct contact with
sample material. Clean contaminated surfaces immediately and dispose of waste according to
regulations.
Sample
Samples containing solids (e.g. separation gel residuals, or fibrin strands) can produce incorrect
results or block probes. For good sample quality, follow the instructions given by the primary
tube manufacturers.
Light source
Danger of eye damage from the bright light of the absorbance photometer lamp. Always wear
dark safety glasses when looking at the light.
Waste
Danger of infectious waste material. This can cause severe illness. Avoid direct contact with
waste.
User Manual · Version 2.7 xv
Carry-over
Traces of analytes may be carried over from one sample to the next. Take adequate measures to
safeguard correct testing of high-sensitive methods (e.g. heterogeneous immuno-assays).
Cassette interchange
Do not interchange cassettes among different COBAS INTEGRA systems and instruments. Each
cassette rack with its cassettes may be used on one individual COBAS INTEGRA instrument
only. Each cassette has its own individual cassette number, which the instrument uses to
identify it. Using a cassette already used on a different COBAS INTEGRA instrument may lead to
incorrect results.
If more than one COBAS INTEGRA instrument is used in the same lab, be sure to dedicate each
cassette rack with its cassettes to one single, individual instrument (e.g. by color coding).
Sample
Samples containing solids can produce false results and block probes. Ensure that samples are
free from insoluble particles.
Reagents
Danger of cauterization and skin poisoning through contact with reagents. Pay attention to the
notes in the corresponding Method Sheet and the warnings on the cassettes.
Quality control
Danger of false results. Patients can be put at risk if false results lead to incorrect diagnosis and
therapy. Carry out the quality control according to regulations.
Waste material
Disposal of all waste material should be in accordance with local guidelines.
Correct use
Use the COBAS INTEGRA 400 plus system only to measure liquid samples with the provided
reagents.
User qualification
Danger due to incorrect operation.
The COBAS INTEGRA 400 plus analyzer should be used by qualified users only.
xvi User Manual · Version 2.7
Cleaning and maintenance
Incorrect cleaning and maintenance can cause damage to personnel and equipment. Perform
cleaning and maintenance according to the procedures described in this publication.
Environmental conditions
Incorrect location can cause incorrect results and damage equipment components. Follow the
installation instructions carefully. Relocating the COBAS INTEGRA 400 plus analyzer should be
carried out by Roche Service only.
Cleaner
Incorrect cleaning materials can damage the COBAS INTEGRA 400 plus analyzer. Organic
solutions damage cuvettes, tubing, and other plastic materials. Use only 70% ethanol solution to
clean the equipment.
Disposal recommendations
All electrical and electronic products should be disposed of separately from the municipal waste
system. Proper disposal of your old appliance prevents potential negative consequences for the
environment and human health.
Disposal of Control Unit Components
Components of your Control Unit such as the computer, monitor, keyboard, etc. which are
marked with the crossed-out wheeled bin symbol are covered by the European Directive on
Waste Electrical and Electronic Equipment (WEEE).
These items must be disposed of via designated collection facilities appointed by government or
local authorities.
For more information about disposal of your old product, please contact your city office, waste
disposal service or your local Roche Support personnel.
Disposal of the Instrument
The instrument must be treated as biologically contaminated-hazardous waste.
Decontamination (i.e., a combination of processes, including cleaning, disinfection and/or
sterilization) is required before reuse, recycling or disposal.
Dispose of the instrument according to local and/or labor regulations. For more information
contact your local Roche Support personnel.
User Manual · Version 2.7 xvii
This equipment has been tested and found to comply with the limits for Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interferences when the equipment is operated
in a residential area. However, this equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the present user
manual, may cause harmful interference to radio communications.
Uninterruptible power supply (UPS)
Depending upon the quality of electrical grounding of the local electrical power
supply, an uninterruptible power supply (UPS) may be required. A UPS is not
provided with the COBAS INTEGRA 400 plus analyzer. The UPS should provide at
least the maximum power listed in the Technical specifications provided in this
manual.
The electromagnetic environment should be evaluated prior to operation of the device.
xviii User Manual · Version 2.7
Software virus warning
Recommendations o Allow connection to authorized external devices only.
o Ensure that all external devices are protected by appropriate security software.
o Ensure that access to all external devices is protected by appropriate security
equipment.
o Do not copy or install any software on the COBAS INTEGRA 400 plus unless it is
part of the system software or you are instructed to do so by Roche Service.
o Do not move or delete any software on control units unless you are instructed to
do so by Roche Service.
o If additional software is required, contact Roche Service to ensure validation of the
software in question.
o Do not use the USB ports to connect other storage devices unless instructed to do
so by the official user documentation or Roche Service.
o Exercise utmost care when using external storage devices such as USB flash drives,
CDs, or DVDs. Do not use them on public or home computers while connecting
to the COBAS INTEGRA 400 plus.
o Keep all external storage devices in a secure place and ensure that they can be
accessed by authorized persons only.
o Use the remote service only for contacting Roche Service or other authorized
usage.
Failure to observe these recommendations may result in data loss or the non-
availability of the system, which may put patients at risk.
Portable storage media can be infected with and transmit computer malware (for example virus,
Trojan horse).
The COBAS INTEGRA 400 plus is not protected against malware.
The customers are responsible for IT security of their IT infrastructure and for preventing the
spread of malware from system to system.
User Manual · Version 2.7 xix
If this product is connected to a local area network, this network must be protected against
unauthorized access. In particular, it must not be linked directly to any other network or the
Internet. 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.
For further information, contact Roche Service.
The 2nd LAN connector must only be used for Roche remote service connectivity. If a remote
service connection is established over an insecure network via an AXEDA client, the device
must be installed behind either a Roche “connect 2” device or a cobas link gateway. The use of
an AXEDA client is the only approved and supported remote service solution. Other non-
intended usage of the LAN connectors could lead to unauthorized database access resulting in
possible disclosure or modification of sensitive data.
xx User Manual · Version 2.7
Safety labels on the system
Warning labels have been placed on the analyzer to draw your attention to areas of
potential hazard. The labels for the laser transmitter are listed below according to their
location on the analyzer.
The safety labels on the instrument comply with the following standards: ANSI Z535,
IEC 61010-1, IEC 60417-DB-3M, or ISO 7000.
If the labels are damaged, they must be replaced by Roche Service personnel. For replacement
labels contact your local Roche representative.
Safety label on analyzer Location and meaning
Laser transmitter warning
Situated inside of the rack access panel
to designate the presence of a laser
transmitter. Do not stare into the laser
transmitter.
Laser transmitter warning
Situated outside of the rack access panel
to designate the presence of a laser
transmitter. Do not stare into the laser
transmitter.
For details, see "Safety information for laser transmitters" on page xxi.
/