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cobas pro SSU

Roche cobas pro SSU, cobas c 503, cobas e 801, cobas pro ISE analytical unit, cobas pro sample buffer unit, cobas pro sample supply unit Reference guide

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cobas
®
pro integrated solutions
<ISE | c503 | e801>
Quick Reference Guide
Publication version 3.0
Software version 02-01
2
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Publication information
Publication version Software version Revision date Change description
1 01-01 2018-09 First version
1.1 01-02 2019-03 Numerous minor additions and improvements
2.0 01-03 2019-07 Minor corrections
2.1 01-04 2019-12 Minor corrections
3.0 02-01 2020-10 Hardware variant with decentralized water and power supply
added.
New software features, numerous improvements and
corrections implemented
y Revision history
Edition notice
This publication is intended for operators of cobaspro
integrated solutions.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.
Where to find information
The User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Configuration information
• Background information, for example, about analytical
principles
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
system.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
The Quick Reference Guide gives a brief introduction
to important routine tasks and daily maintenance.
The cobas
®
e‑library provides access to important
updates, Method Sheets, Value Sheets, and other
important documents from Roche.
3
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
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 system in a way that is not described
in this publication.
r Store all publications in a safe and easily retrievable
place.
Copyright
© 2018–2021, Roche Diagnostics GmbH.
All rights reserved.
Contact addresses
Inside 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
Authorized
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Outside the European Union and
EFTA member states
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Distributed in USA by: Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana, USA
4
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
5
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Table of contents
Main workflow ........................................................................ 6
Quick reference: Before routine operation ................. 7
Quick reference: Pre-routine workflow .............. 7
Quick reference: Replacing reagents.................. 9
Quick reference: During routine operation.................. 14
Quick reference: Running patient samples....... 14
Quick reference: Checking test results .............. 16
Quick reference: Performing calibration............ 17
Quick reference: Performing QC........................... 18
Quick reference: After routine operation...................... 20
Quick reference: Post-routine workflow ............ 20
Reference information.......................................................... 22
Quick reference: Reagents and consumables
- ISE..................................................................................
22
Quick reference: Reagents and consumables
– c503 ............................................................................
24
Quick reference: Reagents and consumables
– e801 ............................................................................
27
Quick reference: cobaseflow HIV Duo ...........
30
Maintenance logs ....................................................... 31
6
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Main workflow
Main workow
Software Instrument
Before operation
1
Logging on
2
Checking for alarms
3
Selecting Preventive Action check box
4
Performing recommended maintenance actions
5
• Generating a reagent management list
• Checking the status of consumables and waste
6
Replacing missing reagents
7
Downloading parameters
8
• Ordering recommended calibrations and QC
measurements
• Generating calibration and QC load lists
9
Running calibration and QC measurement
10
Verifying calibration and QC results
11
Deselecting Preventive Action check box
During operation
12
Ordering tests
13
Loading and processing samples
14
Checking test results
15
Performing post-routine actions (daily maintenance)
7
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Quick reference: Before routine operation
In this section
Quick reference: Pre-routine workflow(7)
Quick reference: Replacing reagents(9)
Quick reference: Pre-routine workflow
The system is intended for continuous operation (24/7).
At the beginning of a shift, log on to the system and
perform the pre-routine actions highlighted by colors in
the Pre-Routine dialog box.
Colors
Perform at least the actions highlighted yellow or red.
Red: Action is crucial. Examples: A reagent is empty, or a
maintenance action is overdue.
Yellow: Action is needed. Examples: A reagent is below
the defined warning level, or a calibration is required.
Purple: Loading new reagent is recommended. At least
one reagent is below the set daily requirement and the
Preventive Action check box is selected.
Gray: No action needed.
m The system or the masked analytical unit is in
Standby mode.
Steps User action
1 Checking for alarms 1. If the Alarms button flashes yellow or red,
choose the Alarms button.
2. Check the alarms and perform the
recommended remedies.
3. Delete the alarms.
2 Selecting Preventive
Action check box
1. Choose the Pre-Routine button.
2. Select the Preventive Action check box.
3 Updating software
components
1. Choose Pre-Routine > Update SW
Components.
2. Select the software version and language
package to be installed.
3. Choose the Perform button.
y Performing pre-routine actions
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
4 Replacing missing reagents 1. Choose Pre-Routine > Reagent
Management List.
2. Choose the Confirm button.
3. Choose the Refresh button.
4. Choose the reagent management list.
5. Fetch the indicated reagents from the
reagent storage.
6. Replace the reagents.
u Quick reference: Replacing reagents (9)
5 Downloading parameters 1. Choose Pre-Routine > Download
Required Items.
2. Check all tabs for available parameters.
3. Choose the desired item and choose the
Continue button.
– The latest release is recommended.
– Choose the desired settings and
choose the Download button.
4. If you have downloaded a new application,
load the corresponding reagent pack.
6 Performing recommended
maintenance actions
1. Choose Pre-Routine > Recommended
Maintenance.
2. Choose and perform all maintenance
actions highlighted yellow or red.
7 Ordering recommended
calibrations
1. Choose Pre-Routine > Recommended
Calibration.
2. To order the recommended calibrations,
choose the Confirm button.
8 Ordering QC
measurements
1. In the Pre-Routine dialog box, choose the
following:
– Routine QC: To order QC for all
reagent packs in use
– Standby QC: To order QC for all
standby reagent packs
2. Choose the Confirm button.
y Performing pre-routine actions
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
9 Generating calibration and
QC load lists
1. Choose Pre-Routine > Calibrator and QC
Load List.
2. Choose the Confirm button.
3. Choose the Refresh button.
4. In the load lists, check the required
calibrators and QC material with their
assigned rack positions and required use
volume.
10 Running calibration and
QC measurement
1. Prepare calibrators and QC material in
appropriate sample containers.
2. Use black racks for calibrators and white
racks for QC material.
3. Place the racks onto a rack tray, black
calibrator racks first.
4. Load the rack tray onto a loading lane.
5. Start the run.
11 Verifying calibration and
QC results
1. Choose Routine > Recent Calibrations.
2. Verify that all tests have a check mark in the
Status column. If not, choose the Monitor
button from the options menu and
troubleshoot the data alarm.
3. Choose the QC Chart tab.
4. Verify that today’s QC results are within the
acceptable range (green).
When calibration and QC are successful, the
system is ready for sample measurement.
12 Deselecting Preventive
Action check box
1. Choose the Pre-Routine button.
2. To disable purple alarms during operation,
deselect the Preventive Action check box.
y Performing pre-routine actions
u Related topics
• Quick reference: Replacing reagents (9)
Quick reference: Replacing reagents
When a reagent is running short or has expired, replace
it to ensure correct and continuous measurement.
10
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Non-observance of safety messages
Failure to observe safety messages may result in injury,
infection, or damage to the system.
r Use Quick reference tables only as a reminder for
tasks you are familiar to.
r Always observe the Safety Guide and the safety
messages in the corresponding task descriptions.
Steps User action
1 Unloading reagent packs
manually
(for reagent packs that are
not empty or unusable)
1. Choose Reagents > Overview.
2. Select a reagent pack.
3. Choose the Unload button.
4. Select the reagent packs and choose the
Unload button.
5. Press the Reagent Loader button on the
reagent manager of the analytical unit.
6. Remove the unloaded reagent packs.
7. Press the Reagent Loader button again.
2 Loading reagent packs at
the c503 analytical unit
1. Press the Reagent Loader button and wait
until it stops flashing.
2. If reagent packs were unloaded, check the
status indicators:
: Manually selected for unloading.
: Empty or expired reagent pack.
: Temporarily unusable reagent pack,
choose the Alarms button.
3. Remove the unloaded reagent packs.
4. Load reagent packs from refrigerator.
5. Close the reagent manager cover and press
the Reagent Loader button.
: Successfully registered reagent pack.
: Reagent pack could not be registered;
all reagent packs are transferred back.
6. If reagent loader moves to the front again,
press the Reagent Loader button to finish
loading.
y Replacing reagents
11
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
3 Loading reagent packs at
the e801 analytical unit
1. Press the Reagent Loader button and wait
until it stops flashing.
2. If reagent packs were unloaded, check the
status indicators:
: Manually selected for unloading.
: Empty or expired reagent pack.
: Temporarily unusable reagent pack,
choose the Alarms button.
3. Remove the unloaded reagent packs.
4. Fully insert reagent packs from refrigerator
into the reagent loader.
5. Press the Reagent Loader button.
: Successfully registered reagent pack.
: Reagent pack could not be registered;
all reagent packs are transferred back.
6. If the reagent loader moves up again, press
the Reagent Loader button to finish
loading.
4 Replacing reagents– ISE
1. Check the status indicators:
: Empty or expired bottle
: Current bottle
2. Pull up the pipe lifter until it locks.
3. Dry each aspiration pipe with a separate
lint-free cloth.
4. Replace the bottle.
: Bottle successfully registered. The pipe
lifter descends automatically.
5. Close the reagent drawer gently.
The system performs a reagent prime
automatically.
y Replacing reagents
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
5 Replacing system
reagents– c503
(Basic Wash or Acid Wash)
1. Pull out the reagent drawer.
2. Check the status indicators:
: Empty or expired bottle
: Standby bottle (Basic Wash only)
: Current bottle
3. Lift the aspiration pipe and hold it.
4. Dry each aspiration pipe with a separate
lint-free cloth.
5. Replace the bottle.
: Bottle successfully registered.
6. Lower the aspiration pipe.
7. Close the reagent drawer gently.
The system performs a reagent prime
automatically.
6 Replacing system
reagents– e801
(ProCellIIM, CleanCellM,
or PreCleanIIM)
1. Check which status button flashes .
2. Pull up the aspiration pipe and secure it.
3. Dry the aspiration pipe with a lint-free
cloth.
4. Replace the bottle.
5. Lower the aspiration pipe slowly into the
new bottle.
6. Press the status button to confirm the
replacement of this bottle.
: Bottle successfully registered.
7. Close the front door gently.
7 Replacing tip and cup
trays– e801
1. When the status indicator on top is lit, open
the consumables drawer.
2. Remove empty tip and cup trays.
3. Close the consumables drawer.
4. Open the transparent door and load new
tip and cup trays in the lifter.
5. Close the transparent door.
y Replacing reagents
13
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
8 Replacing solid waste
boxes– e801
1. When the status indicator on top is lit, open
the consumables drawer.
2. Remove the full solid waste box and
replace it with a new one.
3. Close the consumables drawer.
4. Open the transparent door and press the
status button corresponding to the
replaced solid waste box.
5. Close the transparent door.
y Replacing reagents
14
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Quick reference: During routine operation
In this section
Quick reference: Running patient samples(14)
Quick reference: Checking test results(16)
Quick reference: Performing calibration(17)
Quick reference: Performing QC(18)
Quick reference: Running patient samples
When all required pre-routine steps are completed, you
can start routine operation and measure samples.
Non-observance of safety messages
Failure to observe safety messages may result in injury,
infection, or damage to the system.
r Use Quick reference tables only as a reminder for
tasks you are familiar to.
r Always observe the Safety Guide and the safety
messages in the corresponding task descriptions.
Steps User action
1 Ordering tests for routine
samples manually (when
not downloaded from host)
1. Choose Routine > Order Tests.
2. Choose the sample type and priority.
3. Choose the Micro option for micro cups, or
the Normal option for other containers.
4. Enter the sample ID from the barcode label.
(In non-barcode mode, enter the sequence
number for a routine sample or rack ID and
position for a STAT sample.)
5. Select all desired tests or test profiles:
– : Test is selected.
– : Result is available.
– : Test is not selected.
6. Choose the Save button.
y Running patient samples
15
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
2 Preparing samples
10 mm
1. Use suitable sample containers only.
2. Maximum fill level: 10mm below the upper
edge of the sample container.
3. Centrifuge the samples according to tube
manufacturer’s recommendation.
4. Sample containers must be vertically
straight on racks.
Use tube adapters for tubes <13mm.
5. Ensure that the sample liquid surface is
free of foam, film, air bubbles, or separator
gel.
3 Preparing barcoded
samples
≥20 mm
≥17 mm
≥17 mm
≥20 mm
<63 mm
<38 mm
1. Use racks with rack ID according to the
rack assignment for the sample type and
container type.
2. Place the barcode label vertically on tubes
within the blue-marked barcode scan zone.
4 Preparing samples in non-
barcode mode
1. To generate the worklist, select the
samples on Routine > Order Tests.
2. Choose Report > Routine > Test Order
List.
3. Choose the Generate button. When the
animation on the Report button ends,
choose the Display button.
4. Place the sample on the rack according to
the Test Order List:
– For routine samples: Note the
sequence number.
– For STAT samples: Note the rack ID
and position.
5 Loading samples onto the
loading lane
1. Ensure that the status indicators of the
sample supply unit are lit, and open the
main cover.
2. Load the rack tray with the handle at the
right side.
If the system is in Operation mode, it
processes the samples without any further
action.
3. If the system is not already in Operation
mode, choose the Start button and start
the run.
y Running patient samples
16
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
6 Loading samples at the
STAT port
1. Use a red rack to indicate samples as STAT
samples.
(In barcode mode, any rack loaded via the
STAT port is processed with the same
priority. In non-barcode mode, only load
red racks at the STAT port.)
2. Load the rack into the STAT port with the
barcodes facing to the right.
If the system is in Operation mode, it
processes the samples without any further
action.
3. If the system is not already in Operation
mode, choose the Start button and start
the run.
7 Starting a run 1. Choose the Start button from the bottom
right of the screen.
2. In non-barcode mode, enter the sequence
number of the first sample to be processed.
3. In the Rack Reception Mode area,
ensure that the setting is switched on.
4. To start the run, choose the green Start
button.
8 Searching for a sample
based on the processing
status
1. Choose Sample Status > Sample
Tracking.
2. If you know the sample ID, enter it and
choose the Search button.
3. To find the processing status, check the
symbol on the sample icon.
y Running patient samples
Quick reference: Checking test results
During or after a run, you can view the results of selected
patient samples and QC measurements.
Steps User action
1 Viewing test results 1. Choose Routine > Results.
2. To view current samples, choose the
Routine View option.
3. From the left table, choose the sample in
question.
Use the All Samples drop-down list to
filter for specific samples.
4. In the right table, check for results already
available and data alarms.
y Checking test results
17
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
2 Viewing test result details 1. On Routine > Results, choose the sample
in question.
2. From the options menu , choose the
Result Details button.
3. If a data alarm is displayed in the Data
Alarms column, look up the alarm
description and perform the described
remedies.
y Checking test results
Quick reference: Performing calibration
The software recommends calibrations according to the
intervals set for each application. You only have to order
the recommended calibrations.
Steps User action
1 Ordering calibrations 1. Choose Calibration > Order.
2. Check the Cause column:
: Calibration is recommended.
: Calibration is ordered for the next run.
3. To order recommended calibrations,
choose the Save button.
4. To order a calibration manually, choose the
test and choose > Calibrate.
2 Running calibrations 1. Choose Report > Calibration >
Calibrator Load List.
Choose the Generate button, then the
Display button.
2. On the load list, check which calibrators
are required. For calibrators having a
position assignment, also check the rack
positions.
3. Prepare calibrators as indicated by the load
list. Consider the dead volume of the used
sample container and the overdraw volume.
4. Load the calibrator racks and start the run.
y Performing calibration
18
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
3 Verifying calibration results
1. When results are available, choose
Calibration > Order.
2. View the R. P. Position column:
No color: Latest calibration was successful.
: The latest calibration failed.
3. If a calibration failed, check for data
alarms:
– On Routine > Recent Calibrations,
choose > Monitor.
– Troubleshoot the data alarm according
to the List of data alarms.
– Repeat the calibration for this test by
choosing the Save button on
Calibration > Order.
4 Viewing details on a
calibration result
1. Choose Calibration > Results > and
choose the test:
– Lot Calibration Result: The last valid
lot calibration of this specific reagent
lot.
– Newest Calibration Result: The last
valid lot calibration of the test.
2. Unload the calibrator racks from the
unloading lanes.
y Performing calibration
Quick reference: Performing QC
You can order QC measurements for all tests and
reagents onboard (routine QC), or for specific or standby
reagents only.
You cannot use expired QC material. Tests ordered for
expired QC material are masked and not performed.
i
You order QC measurements by QC material, not
by QC lot. The system performs the QC
measurement using the first QC lot loaded. The
system does not process any further QC lots for
the same QC material in the same run.
19
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Steps User action
1 Ordering QC for current
reagents
1. Choose QC > Order.
2. To order QC for all current reagents,
choose the Assign Routine QC button.
3. To order QC for specific reagents, select
the corresponding Select check boxes.
4. Choose the Save button.
2 Ordering QC for standby
reagents
1. Choose QC > Order > Standby Bottle
QC.
2. Select the Select check boxes of the
standby reagents for which you require a
QC measurement.
3. Choose the Save button.
3 Running QC 1. Choose Report > QC > QC Load List.
Choose the Generate button, then the
Display button.
2. On the load list, check which QC material
are required on which rack positions.
3. Prepare QC material as indicated by the
load list. Consider the dead volume of the
used sample container and the overdraw
volume.
4. Load the QC racks and start the run.
4 Verifying QC results 1. Choose Routine > QC Chart.
2. Choose a test.
3. Verify that today’s QC results are within the
acceptable range (green circle).
– If QC results are out of range (red
circle), troubleshoot the cause and
repeat the QC measurement.
– When calibration and QC are
successful, the system is ready for
measuring samples.
4. Unload the QC racks from the unloading
lanes.
y Performing QC
20
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Quick Reference Guide · Publication version 3.0
Quick reference: After routine operation
Quick reference: Post-routine workflow
At the end of a daily shift, stop analysis and perform daily
maintenance actions.
Non-observance of safety messages
Failure to observe safety messages may result in injury,
infection, or damage to the system.
r Use Quick reference tables only as a reminder for
tasks you are familiar to.
r Always observe the Safety Guide and the safety
messages in the corresponding task descriptions.
Steps User action
1 Stopping the system after
the current run
1. Choose the Start button.
2. In the Rack Reception Mode area,
choose the Change button.
3. Clear the Activate Rack Reception
Mode check box.
After the run, the system will unload all
racks.
4. If quick start mode is active, perform
Maintenance > 31 Finalization on the
e801 analytical unit.
5. Remove all racks from the unloading lane.
2 Running the daily wash
rack – ISE
1. Prepare a wash rack:
– Pos. 1: empty
– Pos. 2: 600µL ISE Cleaning Solution/
SysClean
– Pos. 3: 600µL Activator
2. Load the wash rack.
3. Start the run.
4. Perform calibration and QC.
3 Cleaning sample probe –
e801
1. Wipe the sample probe with alcohol.
– Then wipe with deionized water.
– Always wipe from top to bottom.
y Post-routine workflow
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