cobas
®
8000 modular analyzer
series
Interlock Manual cobas c 502 module – Version 2.1
Software version 06-02
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
2
Publication information
Edition notice This manual describes extended maintenance actions of
the cobas c 502 module which is part of the
cobas
®
8000 modular analyzer series. These
maintenance actions can only be performed by specially
trained personnel and complement the maintenance
actions described in the Operator’s Manual.
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.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Where to find information
For further information on the cobas
®
8000 modular
analyzer series see:
The Safety Guide contains important safety information.
You must read the Safety manual before operating the
instrument.
The Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
Publication version Software version Revision date Change description
1.0 01-02 2010-01 First version.
2.0 CU: 06-02
DM: 1.06.00
2016-06 New title page image added.
Publication redesigned according to the new Roche
documentation concept.
2.1 CU: 06-02
DM: 1.06.00
2016-10 New title page image added.
Update of screenshots and graphics.
Minor corrections.
y Revision history
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
3
The Online Help contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Information about basic analytical principles
The Routine Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
A separate Operator’s Manual is available for the
cobas
®
8000 data manager.
The PC manufacturer’s manual contains all information
about the control unit hardware.
!
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 retrievable
place.
Training Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Screenshots The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data, such as tests, results, or path names visible
therein must not be used for laboratory purposes.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
4
Copyright © 2010-2016, Roche Diagnostics GmbH. All rights
reserved.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS E, COBAS INTEGRA, and LIFE
NEEDS ANSWERS 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 purpose. 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
®
8000 modular analyzer series meets the
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.
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.
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.
Compliance is provided by means of the Declaration of
Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the IVD directive 98/79/EC on in vitro
diagnostic medical devices
Issued by Intertek for Canada and the US.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
5
Contact addresses
Inside the European Union and
EFTA member states
Outside the European Union and
EFTA member states
Manufacturer of the
instrument
Hitachi High-Technologies
Corporation
1-24-14 Nishi-Shimbashi
Minato-ku Tokyo 105-8717
Japan
Manufacturer of
cobas
®
8000 data
manager
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
Authorized
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
6
T
able of contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 7
What is new in publication version 2.1? . . . . . . . . 10
List of maintenance actions which require the
interlock release tool . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Maintenance as required of the c 502 module . . . . . 13
Replacing nozzle tips on reaction cell rinse
nozzles of the c 502 module . . . . . . . . . . . . . . . . . . 13
Replacing the pipetter probes of the c 502
module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Detaching a sample, EcoTergent, or reagent
probe of the c 502 module . . . . . . . . . . . . . . . . 17
Reattaching a sample, EcoTergent, or
reagent probe of the c 502 module . . . . . . . . . 21
Checking the sample, EcoTergent, and
reagent probes c 502 of the module . . . . . . . . 24
Eliminating clogging of pipetter probes of the
c 502 module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
7
Preface
Use this publication together with the Operator’s Manuals
of the cobas
®
8000 modular analyzer series.
Operation and maintenance actions are described in the
Operator’s Manual and the Online Help.
In this section
Intended use (7)
Symbols and abbreviations (7)
What is new in publication version 2.1? (10)
Intended use
The cobas
®
8000 modular analyzer series is a fully
automated, random-access, software-controlled system
for immunoassays, photometric analysis, and electrolyte
analysis intended for qualitative and quantitative in vitro
determinations using a wide variety of tests.
The cobas
®
8000 modular analyzer series is an in vitro
diagnostic (IVD) medical equipment.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Product name Descriptor
cobas
®
8000 modular analyzer
series
System
cobas
®
8000 data manager
Data manager
cobas
®
ISE module
ISE module
cobas c 702 module c 702 module
cobas c 701 module c 701 module
cobas c 502 module c 502 module
cobas e 801 module e 801 module
cobas e 602 module e 602 module
cobas c pack reagent cassette
cobas e pack reagent cassette
cobas e pack green reagent cassette
cobas e flow cobas e flow test
Sample Cup standard cup
y Product names
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
8 Preface
Symbols used in the publication
Symbols used on products
Micro-Sample Cup micro cup
Sarstedt micro tube cryo cup
AssayTip/AssayCup tray magazine
WasteLiner solid waste box
Product name Descriptor
y Product names
Symbol Explanation
o List item
u Related topics containing further information
q
Tip. Extra information on correct use or useful
hints.
r Start of a task
I Extra information within a task
f Result of 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.
u Topic. Used in cross-references to topics.
p Task. Used in cross-references to tasks.
w
Figure. Used in figure titles and cross-
references to figures.
y
Table. Used in table titles and cross-references
to tables.
z
Equation. Used in cross-references to
equations.
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number
Quantity contained in the package
y Symbols used on products
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
9
Abbreviations The following abbreviations are used:
What is new in publication version 2.1?
This section provides an overview of all major changes in
this publication and the software.
New layout and structure Due to customer feedback, we have updated the layout
and the structure of this publication to help you find
information more easily and perform tasks quicker.
Quantity contained in the package
Orientation of the package during
transportation
Complies with the directive 2011/65/EU on
RoHS
Symbol Explanation
y Symbols used on products
Abbreviation Definition
CellCln1 Basic reaction cell wash solution
(NAOH-D)
CellCln2 Acid reaction cell wash solution
DIL ISE Diluent
ECO-D EcoTergent, additive to the incubation
bath to reduce surface tension
EFTA European Free Trade Association
EN European standard
IVD In vitro diagnostic
LLD Liquid Level Detection
NACL NaCl solution, used as diluent
NaOHD Wash solution for reagent probe wash
and reaction cell wash (D1)
SmpCln1 Basic sample probe wash solution
SmpCln2 Acid sample probe wash solution
SMS Wash solution for reagent probe wash
and reaction cell wash (D2)
SysClean Cleaning solution for ISE flow path and
ECL flow path
y Abbreviations
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
10 List of maintenance actions which require the interlock release tool
Screenshots and Graphics Screenshots have been replaced showing the c 502
module. Graphics have been updated such as new title
page graphic showing the c 502 module highlighted.
Minor corrections Correction of procedure for detaching probe.
u To detach a sample or EcoTergent probe (18)
u To detach the reagent probe (20)
List of maintenance actions which require
the interlock release tool
Maintenance is required to ensure that the instrument
works properly and to keep the risk of contamination low.
You must observe the maintenance intervals listed in the
table.
The listed maintenance intervals are independent of the
operating time unless otherwise noted.
!
Refer to the Safety Guide
u Regular cleaning and maintenance
The following abbreviations are used:
The following table shows only those maintenance
actions for the c 502 module that requires the interlock
release tool. The other procedures are found in the
Chapter Maintenance of the c 502 module.
PO Powered off
SB Standby mode
MM Module masked (Standby mode)
Interval Maintenance actions Instrument mode
As required Replacing nozzle tips on reaction cell rinse nozzles of the c 502
module (13)
SB/MM/PO
Replacing the pipetter probes of the c 502 module (17)
-Detaching a sample, EcoTergent, or reagent probe of the c 502
module (17)
- Reattaching a sample, EcoTergent, or reagent probe of the c 502
module (21)
-Checking the sample, EcoTergent, and reagent probes c 502 of the
module (24)
(a)
PO
Eliminating clogging of pipetter probes of the c 502 module (32) PO
y Overview of maintenance actions
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
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WARNING
!
Infection and injury due to the abuse of the interlock
release tool
The interlock function protects yourself and other
operators from possible infections or injuries during
operation. Only a few maintenance actions require the
interlock function to be inactive.
r Use the interlock release tool only for the
maintenance actions described in this document.
Remove the interlock release tool immediately after
finishing the maintenance action. Use the interlock
release tool only after receiving the training to handle
the instrument, and get enough knowledge of
potential hazard and correct operation. Do not pass
on the interlock release tool to operators who have not
been trained.
u Related topics
• About modes for maintenance
• Maintenance of the c502 module
(a) This task can be carried out in the SB or MM mode.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
12 Maintenance as required of the c 502 module
Maintenance as required of the c 502
module
Perform these maintenance actions as required.
In this section
Replacing nozzle tips on reaction cell rinse nozzles of the
c 502 module (13)
Replacing the pipetter probes of the c 502 module (17)
Eliminating clogging of pipetter probes of the c 502
module (32)
Replacing nozzle tips on reaction cell rinse nozzles of the
c 502 module
If the corner or bottom of a nozzle tip is worn so that
water remains in the reaction cell, you must replace the
nozzle tip, typically every 1 or 2 years.
WARNING
!
Infection and injury due to the abuse of the interlock
release tool
The interlock function protects yourself and other
operators from possible infections or injuries during
operation. Only a few maintenance actions require the
interlock function to be inactive.
r Use the interlock release tool only for the
maintenance actions described in this document.
Remove the interlock release tool immediately after
finishing the maintenance action. Use the interlock
release tool only after receiving the training to handle
the instrument, and get enough knowledge of
potential hazard and correct operation. Do not pass
on the interlock release tool to operators who have not
been trained.
!
Refer to the Safety Guide
u Infectious samples
u Infectious waste
u Moving parts
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
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n • Operator time: approximately 4 minutes per module
• System time: approximately 2 minutes for (4) Probe
Check; 1:30 minutes for (3) Mechanism Check
(30 cycles)
d m Needle-nose pliers or radio pliers
m Nozzle tips
j m The instrument or module is in Standby mode.
m Or: The instrument is powered off.
u Masking a module for background maintenance
u Powering off the instrument
r To replace the nozzle tips
Risk-ID 2.9.3 c502
1
Open the top cover of the c 502 module.
I As the interlock function monitors the top cover,
alarms are issued.
2
Insert the interlock release tool to the interlock switch
box.
I If the interlock release tool is inserted into the
interlock switch box, the analyzer control does not
detect that the top cover is open.
1
2
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
14 Maintenance as required of the c 502 module
3
Turn the interlock release tool clockwise by 90°.
I Now the interlock function is released (inactive).
4
Loosen the retaining screw of the reaction cell rinse
unit and lift off the entire unit.
5
Grip the nozzle tip with pliers and pull it off.
I Be careful not to bend the nozzle.
3
A Retaining screw B Reaction cell rinse unit
4
A
B
A Nozzle tip
5
A
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
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6
Attach new nozzle tips by hand and align them with
the guide bars.
7
Attach the reaction cell rinse unit and tighten the
retaining screw.
8
Make sure that the nozzle tips are correctly aligned
with the reaction cells.
9
Remove the interlock release tool.
10
Close and lock the top cover.
11
If the module is masked, unmask it.
u Related topics
• Unmasking a module
• About modes for maintenance
A Nozzle tip C Reaction cell
B Guide bars
6
B
A
C
A Retaining screw B Reaction cell rinse unit
7
A
B
A Reaction cell C Incorrect alignment
B Correct alignment
8
A
B
C
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
16 Maintenance as required of the c 502 module
Replacing the pipetter probes of the c 502 module
If sample and reagent probes are bent or otherwise
damaged, you must replace them.
Detaching a sample, EcoTergent, or reagent probe of the c 502 module
To replace the sample, EcoTergent, or reagent probe or to
eliminate clogging, you must remove the probe first.
The replacement of a probe can only be performed by
operators who have been trained for extended
maintenance actions.
WARNING
!
Infection and injury due to the abuse of the interlock
release tool
The interlock function protects yourself and other
operators from possible infections or injuries during
operation. Only a few maintenance actions require the
interlock function to be inactive.
r Use the interlock release tool only for the
maintenance actions described in this document.
Remove the interlock release tool immediately after
finishing the maintenance action. Use the interlock
release tool only after receiving the training to handle
the instrument, and get enough knowledge of
potential hazard and correct operation. Do not pass
on the interlock release tool to operators who have not
been trained.
!
Refer to the Safety Guide
u Infectious samples
u Infectious waste
u Moving parts
n Approximately 4 minutes per pipetter probe
j m The instrument is powered off.
u Powering off the instrument
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
17
r To detach a sample or EcoTergent
probe
1
Open the top cover.
2
Remove the pipetter arm cover by pressing the
pipetter arm cover releases on either side and gently
lifting the cover.
I When detaching the tubing, water flows out of the
tip of the sample probe. Be sure to work above the
rinse station.
3
Unscrew the tubing from the probe.
1
2
A Tubing
3
A
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
18 Maintenance as required of the c 502 module
4
Locate the probe seal either on the end of the tubing
or in the retaining nut.
5
Disconnect the connector of the liquid level sensor.
6
Lift the probe from the pipetter arm.
A Retaining nut B Probe seal
4
B
A
A Connector of the liquid level sensor
5
A
6
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
19
r To detach the reagent probe
1
Open the top cover.
2
Loosen the knurled counter nut by turning it
counterclockwise and the lower probe retaining nut
by turning it clockwise.
3
Disconnect the tubing connector of the reagent
tubing.
1
2
3
Roche Diagnostics
cobas® 8000 modular analyzer series · Software version 06-02 · Interlock Manual · 2.1
20 Maintenance as required of the c 502 module
4
Lift the probe from the pipetter arm.
u Related topics
• Checking the sample, EcoTergent, and reagent probes
c 502 of the module (24)
• Eliminating clogging of pipetter probes of the c 502
module (32)
Reattaching a sample, EcoTergent, or reagent probe of the c 502 module
After having removed the sample, EcoTergent or reagent
probe to replace or eliminate clogging, you must then
reattach the probe.
!
Refer to the Safety Guide
u Infectious samples
u Infectious waste
u Moving parts
n Approximately 4 minutes per pipetter probe
d m Sample, EcoTergent, or reagent probes (in case
replacement is required)
j m The instrument is powered off.
u Powering off the instrument
4
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