The Roche cobas p 612 is a versatile device that combines the functionality of the cobas p 512 with an optional cobas® connection module (CCM). This module allows for the integration of additional drawers, Hitachi and Sysmex rack feeds, enabling automated sample handling and sorting. The CCM operation is fully integrated into the system's routine work cycle.
The Roche cobas p 612 is a versatile device that combines the functionality of the cobas p 512 with an optional cobas® connection module (CCM). This module allows for the integration of additional drawers, Hitachi and Sysmex rack feeds, enabling automated sample handling and sorting. The CCM operation is fully integrated into the system's routine work cycle.
cobas® connection module
Manual Extension
cobas® connection module
2 Manual Extension - Version 1.4 - 12/2014
Manual version
Version
Creation date
1.0
November 2012
1.1
February 2013
1.2
March 2013
1.3
January 2014
1.4
December 2014
Edition notice
cobas® connection module manual extension
This document is for users of the cobas p 512 and/or cobas p 612 equipped with the optional
cobas® connection module (CCM). It extends the operator's manual of the housing cobas
system.
Software compatibility
This manual extension has been written for cobas p 512 and cobas p 612 with installed
software version 1.6 or higher.
Copyrights
This manual is a product of Roche PVT GmbH.
All rights are reserved. No part of this manual may be reproduced in any form (print,
photocopy, microfilm or another procedure) or processed using electronic systems, copied
or distributed without the written permission of the company.
The company assumes no liability for any errors, omissions or damages resulting from the
use of the information contained in this manual.
Note: All of the product names contained in this manual are trademarks of the respective
companies. If the trademark symbols © or ® are not included, it cannot be assumed that the
name is an unregistered product name.
The content of this manual is subject to change without any communicative obligations by
the company.
Copyright© Roche PVT GmbH, Waiblingen 2014
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Manual Extension - Version 1.4 - 12/2014 3
Norms and standards
The cobas® connection module (installed on either cobas p 512 or cobas p 612) conforms to
the currently applicable directives of the European Union. Compliance with all standards
and legal obligations is guaranteed.
CE labeling corresponds to the EU directives 98/79/EU (IVD Directive).
The requirements, limits and tolerances stated in the following standards are complied with:
• "DIN EN 61326 (EMC requirements for electrical laboratory instruments)
• "DIN EN 61010-1 (Safety requirements for electrical laboratory instruments)
Contact address
Manufacturer
Roche
Diagnostics GmbH
Sandhofer Str. 116
D
-68305 Mannheim
Germany
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Table of contents
1.
Operation ..................................................................................................... 7
1.1. Routine ► Control (static target assignment) ......................................... 7
1.1.1 Work cycle ........................................................................................................................... 7
1.1.2 Rack feed control .............................................................................................................. 8
1.1.2.1 Rack depiction ................................................................................................................ 8
1.1.2.2 [Activate/Deactivate] button .................................................................................... 9
1.1.3 CCM status .......................................................................................................................... 9
1.2. Routine ► Control (dynamic target assignment) ................................. 10
1.2.1 Work cycle ......................................................................................................................... 10
1.2.2 Rack feed control ............................................................................................................ 11
1.2.2.1 Rack depiction ............................................................................................................. 11
1.2.2.2 [Activate/Deactivate] button ................................................................................. 12
1.2.3 CCM status ........................................................................................................................ 12
1.2.4 Purging the buffer rack ( [Empty buffer] )............................................................. 12
1.2.5 Suspending a target's assignment ........................................................................... 13
1.2.6 Prioritization: "batches of 5 only" .............................................................................. 14
1.2.7 Flowchart: tube sorting and target assignment ................................................... 15
1.2.8 Flowchart: Timed-out sample tubes in buffer ...................................................... 16
1.3. Rack feeds (Hitachi) .................................................................................... 17
1.3.1 Automatic functions ....................................................................................................... 17
1.3.2 Manual tasks..................................................................................................................... 17
1.3.2.1 Replenishing a partially filled rack supply ....................................................... 18
1.3.2.2 Exchanging empty rack trays ................................................................................ 19
1.3.2.3 General instructions for loading the rack trays ............................................. 20
1.4. Rack feeds (Sysmex) ................................................................................... 21
1.4.1 Automatic functions ....................................................................................................... 21
1.4.2 Manual tasks..................................................................................................................... 21
1.4.2.1 Replenishing a partially filled rack supply ....................................................... 22
1.4.2.2 Reloading an empty rack tray ............................................................................... 23
1.4.2.3 General instructions for loading the rack trays ............................................. 24
2. Maintenance ............................................................................................ 25
2.1. Care and maintenance schedule .............................................................. 25
2.2. Cleaning the optical sensors ...................................................................... 25
3. Troubleshooting ....................................................................................... 26
3.1. What do I do if ...? ......................................................................................... 26
3.1.1 ... a rack within the retaining brackets needs to be removed? ...................... 26
3.1.2 ... the gripper lost an open tube at the CCM station? ....................................... 26
3.1.3 ... a tube's content is spilled whenever its rack is moved? .............................. 27
3.1.4 ... a rack becomes jammed at the rack output? .................................................. 27
3.1.5 ... an error occurs on the Aloka rack conveyor? ................................................. 28
3.2. Error messages.............................................................................................. 29
4. Rack specifications ................................................................................. 32
4.1. Sysmex variant .............................................................................................. 32
4.2. Hitachi variant ............................................................................................... 32
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1. Operation
Three different submodules can be integrated into the cobas® connection module:
• an additional drawer
• rack feeds for Hitachi 5-slot racks or MPA racks (up to three in total)
• rack feeds for Sysmex 10-slot racks (up to two in total)
The combination of these submodules directly affects the depiction of the CCM within the
control software. The process depiction shown in figure 1 contains one additional drawer
and two Hitachi rack feeds. This configuration is only exemplary as the module itself can be
widely customized.
The CCM's operation is completely integrated into the system's routine work.
1.1. Routine ► Control (static target assignment)
NOTICE
There are two different variants for the implementation of CCM available. The description in this
chapter refers to the variant where each CCM line is assigned to a specific target or group of
identical targets. Please refer to chapter 1.2 for instructions on the dynamic assignment variant.
Once the module is mounted and the system's control software is accordingly configured,
you'll see a slightly changed process depiction at 'Routine' ▶ 'Control'.
Figure 1: submenu 'Routine' ► 'Control' (example for static assignment)
A
Latest rack's origin and its target
C
Button for rack feed control
B
Transfer position of rack feed
D
Output sorter
1.1.1 Work cycle
If your system has been subsequently upgraded with the cobas® connection module, there
might still be work cycles within the system's database that do not utilize this new hardware
configuration.
CAUTION
Be aware that these work cycles may no longer be used for routine work, if they
include workplaces on one of the drawers that have been replaced with CCM rack
feeds.
A
B
C
D
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1.1.2 Rack feed control
In terms of the graphical user interface of the system, the two different types of CCM rack
feeds (Hitachi and Sysmex) only differ by the depicted number of sorting positions. Their
handling is exactly the same. The depiction of a rack feed contains two control items:
Figure 2: Rack feed depictions (Hitachi / Sysmex)
A
Transfer position of rack feed
B
Control button
1.1.2.1 Rack depiction
Similar to the workplace depictions on the output sorter's drawers, the CCM rack depictions
likewise work as a removal button. When the rack depiction is pressed, the corresponding
Hitachi or Sysmex rack is prioritized for being pushed out onto the rack transport and then
moved towards the connected conveyor.
The rack depiction's frame color indicates whether a rack is available within the retainer at
the transfer position (dark grey) or if the retainer is empty (white):
There is no rack within the
retainer in front of the rack
transport or the retainer is
currently moving one onto it.
The retainer in front of the
rack transport holds a rack.
The rack feed is inactive. Its
feed lever/nooks are in start
position.
The rack feed is active. Its
feed lever/nooks are
pressing against the racks
on the rack tray/holder.
Table 1: all states of a CCM submodule (here: Hitachi)
A
B
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1.1.2.2 [Activate/Deactivate] button
The control button below the rack depiction is utilized to either withdraw the corresponding
feed lever/nooks towards their start position ("Deactivate"), or to initiate their movement
towards the racks loaded onto the rack tray ("Activate").
NOTICE
For safety reasons, the rack feed levers/nooks will only move while the system is in normal
operation. If the button is pressed when the system is in standby mode, the command is accepted
but its execution will be delayed until the system is running again.
1.1.3 CCM status
Above the depiction of the rack feed(s), there is a line of text:
Figure 3: status line latest rack
This text shows data on the latest rack that has been pushed onto the rack transport,
including …
1. … the rack's origin (as in the rack feed's workplace abbreviation).
2. … the rack's serial number. Throughout the entire work cycle, this counter is
incremented every time a rack is pushed off onto the rack transport. It is only reset
when a reorganization of the database is performed via 'Routine' ▶ 'Clear data'.
3. … the rack's intended target system (an individual number assigned to every end point
of the connected rack conveyor system).
The aforementioned data's display is abiding by this syntax:
<origin>.<serial> --> <target>
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1.2. Routine ► Control (dynamic target assignment)
NOTICE
There are two different variants of CCM implementation available. The description in this chapter
refers to the variant where each CCM line is assigned dynamically to one of up to seven individual
targets or groups of targets during runtime.
Please refer to chapter 1.1 for instructions on the static assignment variant.
Once the module is mounted and the system's control software is accordingly configured,
you'll see a slightly changed process depiction at 'Routine' ▶ 'Control':
Figure 4: submenu 'Routine' ► 'Control' (example for dynamic assignment)
A
Latest rack's origin and its target
D
Button [Empty buffer]
B
Transfer position of rack feed
E
Output sorter
C
Button for rack feed control
F
Target activation/deactivation buttons
1.2.1 Work cycle
If your system has been subsequently upgraded with the cobas® connection module, there
might still be work cycles within the system's database that don't utilize this new hardware
configuration.
CAUTION
Be aware that these work cycles may no longer be used for routine work, if they
include workplaces on one of the drawers that have been replaced with CCM rack
feeds.
A
B
C
D
E
F
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1.2.2 Rack feed control
In terms of the graphical user interface of the system, the two different types of CCM rack
feeds (Hitachi and Sysmex) only differ by the depicted number of sorting positions. Their
handling is exactly the same. The depiction of a rack feed contains two control items:
Figure 5: Rack feed depictions (Hitachi / Sysmex)
A
Transfer position of rack feed
B
Control button
1.2.2.1 Rack depiction
Unlike the static assignment variant of CCM (see chapter 1.1), racks on the transfer position
are only depicted when the system has assigned a designated target to them. This difference
is also made clear by explicitly showing the rack's assigned target below its depiction.
Similar to the workplace depictions on the output sorter's drawers, the CCM rack depictions
likewise work as a button. When the rack's depiction is pressed, the corresponding rack is
prioritized for being pushed out onto the rack transport and then moved towards the
connected conveyor.
The rack in transfer
position is not
assigned to any target.
The rack in transfer
position is assigned to
the target shown
beneath it.
The rack in transfer
position is marked for
dismissal onto the
rack transport.
The rack feed is
inactive. Its feed
lever/nooks are in
start position.
The rack feed is
active. Its feed
lever/nooks are
pressing against the
racks on the rack
tray/holder.
Table 2: all states of a CCM submodule (here: Hitachi)
A
B
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1.2.2.2 [Activate/Deactivate] button
The control button below the rack's depiction is utilized to either withdraw the
corresponding feed lever/nooks towards their start position ("Deactivate"), or to initiate their
movement towards the racks loaded onto the rack tray ("Activate").
NOTICE
For safety reasons, the rack feed levers/nooks will only move while the system is in normal
operation. If the button is pressed when the system is in standby mode, the command is accepted
but its execution will be delayed until the system is running again.
1.2.3 CCM status
Above the depiction of the rack feed(s), there is a line of text:
Figure 6: status line latest rack
This text shows data on the latest rack that has been pushed onto the rack transport,
including …
1. … the rack's origin (as in the rack feed's workplace abbreviation).
2. … the rack's serial number. Throughout the entire work cycle, this counter is
incremented every time a rack is pushed off onto the rack transport. It is only reset
when a reorganization of the database is performed via 'Routine' ▶ 'Clear data'.
3. … the rack's intended target system (an individual number assigned to every end point
of the connected rack conveyor system).
The aforementioned data's display is abiding by this syntax:
<origin>.<serial> --> <target>
1.2.4 Purging the buffer rack ( [Empty buffer] )
During routine operation, sample tubes temporarily put away into the buffer rack are
automatically considered for sorting again when…
• … their residence time within the buffer has exceeded the timeout set for their
intended target (see flowchart on page 16).
• … their priority submits them to the "batches of 5 only" sorting rule (see flowchart on
page 15) and there are 5 tubes intended for the same target available in the buffer.
These two cases apart, the tubes remain inside the buffer.
The button [Empty buffer] overrides both aforementioned rules and forcibly purges the
buffer in accordance with the sorting targets they are intended for.
NOTICE
Manually purging the buffer will halt all sorting of tubes from the tube transports.
Once initiated, the procedure cannot be interrupted until the buffer is completely clear.
Keep in mind that the system cannot sort tubes from the buffer if their intended target's assignment
was suspended (see chapter 1.2.5)!
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1.2.5 Suspending a target's assignment
When a target connected to the ALOKA transport system is not available for the time being
(e.g. during maintenance), the CCM's automated target assignment can be modified in order
to omit this particular target until further notice.
For every configured target system along the ALOKA rack transport, a button is displayed on
the lower right side of the submenu 'Routine'' ► 'Control'. Pressing these buttons will toggle
the assignment of the corresponding target(s) on or off.
Figure 7: Buttons for suspending a target's assignment (exemplary)
When you press one of the target buttons, it will be highlighted in black (see Figure 7).
This would temporarily suspend the assignment of the corresponding target. In consequence,
whenever a loaded rack is dismissed onto the rack transport and the rack feed thus becomes
available for a new target assignment, the system would disregard suspended targets.
Pressing a highlighted target button will resume the assignment of the corresponding target
again.
NOTICE
Manually suspending a target's assignment outranks all of the CCM's sorting and timeout rules.
In consequence, the system's automated prioritization of timed-out samples inside the buffer will be
suspended as well in terms of the affected target.
While their intended target is suspended, the depiction of all affected tubes inside the buffer
rack is crosshatched in order to facilitate their discernibility:
Figure 8: Buffered tubes with their target being suspended
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1.2.6 Prioritization: "batches of 5 only"
Every CCM target has its own priority level. During operation, this priority is checked
against the priority level of a special rule called "batches of 5 only".
This rule determines that all affected tubes will be sorted into the buffer rack first until 5 of
them have been collected. Only then the system will try to assign a rack feed to their target
and move the whole batch there.
There are two exceptions to this rule:
• If the residence time of an affected tube inside the buffer is exceeded, the "batches of 5
only" rule does no longer apply to this tube since the priority of timed-out tubes
always outranks that.
• The button [Empty buffer] disregards the "batches of 5 only" rule as well since its sole
purpose is to clear the buffer rack entirely, regardless of the number of tubes intended
for the same target.
NOTICE
For further information about target prioritization, please refer to the CCM annex of the system's
service manual.
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1.2.7 Flowchart: tube sorting and target assignment
Figure 9: CCM workflow, normal operation
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1.2.8 Flowchart: Timed-out sample tubes in buffer
Figure 10: CCM workflow, buffered tube elapsed timeout
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1.3. Rack feeds (Hitachi)
Hitachi rack feeds consist of several parts:
• Tray holder: Hosts the rack tray and keeps it locked in place.
• Rack tray: Can be loaded with up to 30 racks and is removable. Has a guide rail that
aligns the racks and keeps them from tipping over.
• Feed lever: Pushes the racks from the tray into the rack retainer at the transfer
position. The Hitachi variant uses a folding feed lever that needs to be manually tilted
into its horizontal or upright position.
• Rack retainer: Its brackets lock the tray's foremost rack at the transfer position where
it is then loaded with sample tubes from the sorting unit.
The retainer is also responsible for moving loaded racks onto the rack transport.
1.3.1 Automatic functions
During operation, the empty racks on the rack trays are successively pushed into the retainer
at the transfer position. The retainer's brackets keep them in place while they are loaded with
tubes from the sorting unit. Once a rack is full (or in case of a manual trigger), it is pushed
onto the rack transport.
Furthermore, the system is configured with specific timeout functionality for incomplete
racks. This function prevents partially loaded racks to remain on their transfer position for
too long by pushing them onto the rack transport automatically once their timeout expires.
Whenever the sorter unit is unable to sort a tube into the intended rack at the CCM's transfer
position (e.g. due to a congestion), a preconfigured timer is initiated. Once the timer elapses
and the tube still cannot be sorted as intended, it is put away temporarily into a defined
buffer workplace on one of the output sorter's drawers.
The system continuously compares the residence time of every tube in both the buffer and
the rack feeds' transfer positions and compares it to a predefined, target-specific timeout.
Whenever a timeout elapses, an override procedure (see chapter 1.2.8) is put into action in
order to sort such affected tube by disregarding most of the objecting sorting rules.
The target systems on the interconnected ALOKA rack transport are each assigned to
specific workplace. During operation, these workplaces are dynamically assigned to one of
the CCM rack feeds (see chapter 1.2.7). The assignment is renewed according to demands in
terms of waiting tubes in the buffer or on the tube transport as well as every time one of the
rack feeds dismisses a loaded rack onto the rack transport.
1.3.2 Manual tasks
Besides rectifying potential malfunctions and, if necessary, emptying the buffer workplace at
the end of the day, the system's operator only needs to replenish the supply of empty racks on
the corresponding trays. This can be done by …
1. … reloading the inserted rack trays directly within the output sorter.
(see chapter 1.3.2.1 for details)
2. … exchanging empty rack trays against filled ones that have been previously prepared.
(see chapter 1.3.2.2 for details)
Either way the system needs to be in standby mode before the CCM's rack trays can be
accessed.
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1.3.2.1 Replenishing a partially filled rack supply
To replenish the tray's rack supply before it actually becomes empty, proceed as follows:
1. In the submenu 'Routine' ▶ 'Control', press the [Deactivate] button below the desired
rack feed's depiction. The corresponding feed lever will then withdraw into its start
position near the tray's handle.
Figure 11: feed lever is withdrawing
2. Press [Standby] in order to halt operation.
3. Open the safety door of the output sorter.
4. Manually tilt the feed lever into vertical position.
Figure 12: tilt feed lever into vertical position
5. Load up to 30 empty racks of the corresponding type into the rack tray.
6. Manually tilt the feed lever down into horizontal position again.
Figure 13: tilt feed lever into horizontal position
7. Close the safety door of the output sorter.
8. Press [Run] in order to resume operation. The (formerly deactivated) rack feed will
reactivate itself automatically.
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1.3.2.2 Exchanging empty rack trays
If one of the rack feeds runs out of empty racks during operation, the system will issue an
error message while retracting the corresponding feed lever back to its start position.
Once operation is automatically halted, proceed as follows:
1. Press the [Standby] button.
2. Open the safety door of the output sorter.
3. Manually tilt the feed lever into vertical position.
Figure 14: tilt feed lever into vertical position
4. Remove the empty rack tray and insert a filled one into the tray holder. Make sure the
tray is firmly seated inside before proceeding.
5. Manually tilt the feed lever down into horizontal position again.
Figure 15: tilt feed lever to horizontal position
6. Close the safety door of the output sorter.
7. Press [Run] in order to resume operation.
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1.3.2.3 General instructions for loading the rack trays
When loading rack trays with empty racks, accuracy is crucial for the racks' further
processing. This also applies to the insertion of the trays into the CCM's tray holders. Even
though constantly monitoring the rack trays via sensory data, the system cannot compensate
operating errors like e.g. inserting empty Hitachi racks directly into the tray holder (without
the proper tray).
NOTICE
When loading the rack tray, always make sure the recess in the racks' base is placed correctly onto
the guide rail of the tray!
OK
X
X
On insertion of the tray into the tray holder of the CCM, always make sure that the tray is
firmly seated within the holder and is flush with its surface. If it even so much as slightly
topples or if it can be slid back and forth after insertion, remove it and try again!
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Roche cobas p 512 Short Guide
- Type
- Short Guide
- This manual is also suitable for
The Roche cobas p 612 is a versatile device that combines the functionality of the cobas p 512 with an optional cobas® connection module (CCM). This module allows for the integration of additional drawers, Hitachi and Sysmex rack feeds, enabling automated sample handling and sorting. The CCM operation is fully integrated into the system's routine work cycle.
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