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cobas 8000 / ISE Module

Roche cobas 8000 / ISE Module, cobas 8000 core unit, cobas c 502, cobas c 701, cobas c 702, cobas e 602, cobas e 801 Reference guide

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cobas
®
8000 modular analyzer
series
Quick Reference Guide
Version 2.1
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
2
Publication information
Intended use
The cobas
®
8000 modular analyzer series system is a
fully automated random-access software-controlled
system for immunoassays and photometric 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.
Edition notice This publication is intended for operators of the
cobas
®
8000 modular analyzer series.
Every effort has been made to ensure that all the
information is correct at the time of publishing. However,
Roche Diagnostics reserves the right to change this
publication as necessary and without notice as part of
ongoing product development.
Where to find information The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
instrument.
The Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
The Online Help contains the content of the Operator’s
Manual, Safety Guide and additionally:
• Troubleshooting information
• A software reference
• Configuration information
• Information about basic analytical principles
Document version Software version Revision date Change description
1.0 CU: 06–02
DM: 1.06
May - 2016 Initial version
2.0 CU: 06–03
DM: 1.06
Nov - 2016 Inclusion of information on the ISE support box
2.1 CU: 06–03
DM: 1.06
May - 2017 Minor changes throughout the document
y Revision history
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
3
!
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the instructions and safety information
before you use the instrument.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not
described in this publication.
r Store all publications in a safe and easily retrievable
place.
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.
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.
Copyright © 2017 F. Hoffmann-La Roche Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS P, 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 use. 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.
Instrument approvals
The cobas
®
8000 modular analyzer series meets the
requirements of the Directive 98/79/EC.
The following marks demonstrate compliance:
Issued by Underwriters Laboratories, Inc. (UL) for Canada
and the US.
CUS
®
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
4
Issued by CSA Group for Canada and the US.
Complies with the IVD directive 98/79/EC.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
5
T
able of contents
Workflow overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pre-routine tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1. Starting up the system. . . . . . . . . . . . . . . . . . . . . 8
2. Preparing the system . . . . . . . . . . . . . . . . . . . . . . 9
3. Loading reagents, system reagents, and
consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Loading on the ISE module . . . . . . . . . . . . . . . . 13
Loading on the c 702 module . . . . . . . . . . . . . . 15
Loading on the c 701 module . . . . . . . . . . . . . . 17
Loading on the c 502 module . . . . . . . . . . . . . . 19
Loading on the e 602 module . . . . . . . . . . . . . . 21
Loading on the e 801 module . . . . . . . . . . . . . . 23
4. Processing the wash rack . . . . . . . . . . . . . . . . . . 25
Processing the wash rack (for chemistry
modules) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Performing calibration and QC
measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5. Calibration recommendation. . . . . . . . . . . . . . . . 27
Routine tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Creating a sample order manually . . . . . . . . . . . . . 31
Assigning a sample order to a rack position . . . . 32
Validating test results . . . . . . . . . . . . . . . . . . . . . . . . 33
Masking and unmasking tests or modules. . . . . . 35
Powering off the instrument and rebooting the data
manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
6 Workflow overview
Workflow overview
Pre-routine tasks
1
Starting up the system
4
Processing the wash rack
5
Measuring calibration and QCs
2
Preparing the system
3
Loading reagents, system reagents, and
consumables
Routine tasks
Creating a sample order manually (as needed)
Assigning a sample order to a rack position
Validating test results
Masking and unmasking tests or modules
Starting routine run
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
Pre-routine tasks 7
Pre-routine tasks
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Pre-routine tasks
1
Starting up the system
- Inspecting the instrument
- Powering up the system
- Logging on to the control unit
- Logging on to the data manager
4
Processing the wash rack
- Preparing the wash rack
- Loading the wash rack on the core unit
- Performing the ISE calibration
5
Measuring calibration and QCs
- Creating the Calibrator/QC Load List
- Preparing calibrator/QC material
- Placing calibrator/QCs on rack
- Starting calibration/QC measurements
- Validating calibration results
- Validating QC results
- Validating QC results on the data manager
2
Preparing the system
- Enabling the preventive actions
- Troubleshooting instrument data alarms
- Clearing the printer memory
- Starting a maintenance action manually
- Deleting the sample database
- Checking the Information window on the data manager
- Deleting open orders (weekly) on the data manager
- Starting data cleanup manually on the data manager
3
Loading reagents, system reagents, and
consumables
- Creating the Reagent Load/Unload List
- Loading reagents, system reagents, and consumables
- Loading on the ISE module
- Loading on the c 702 module
- Loading on the c 701 module
- Loading on the c 502 module
- Loading on the e 801 module
- Loading on the e 602 module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
8 Pre-routine tasks
1. Starting up the system
You can program the instrument to start up at a specific
time.
Instrument inspection Perform the instrument inspection either before startup or
after power off. Especially if the instrument has been set
for automatic startup, ensure that the inspection is done
at the end of the previous working session.
If any problems arise, refer to the module-specific
maintenance and troubleshooting chapters in the
instrument Operator’s Manual.
Steps User action
1
Inspecting the instrument 1. Check that the main water supply is turned
on.
2. The concentrated liquid waste container is
clean and empty.
3. Unload all calibrator racks, QC racks, and
sample racks.
4. Unload all empty reagent cassettes.
2
Powering up the system 1. Switch on the data manager.
2. Switch on the core unit. The instrument
goes into the Standby mode after
initialization.
3
Logging on to the control unit 1. Enter your operator ID and password.
2. Confirm your entry with the Logon button.
4
Logging on to the data
manager
1. Enter your user name and password.
2. Confirm your entry with the Logon button.
y Starting up the system
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
9
2. Preparing the system
If the instrument was not powered off, or the daily
maintenance pipe could not be performed, you can start
maintenance pipes or maintenance actions manually.
Instrument alarms
If the Alarm button flashes yellow or red, you must check
the cause of the alarm.
The color indicates the alarm level:
• Red: Stop level. Operation cannot be continued.
• Yellow: Caution level. Operation can be continued.
Maintenance status
The color of the button indicates whether you must
perform at least 1 maintenance action.
• Yellow: A warning level is exceeded.
• Red: A maintenance interval is exceeded.
Clearing the sample database
The color of the button indicates whether you must
perform at least 1 maintenance action.
• Yellow: Clear the sample database as soon as possible
because it is almost full.
• Red: The sample database is full (12 000 patient and
QC samples). The analyzer does not process any
further samples.
The software provides 2 options:
• The Clear option deletes the database without saving
the test results. Use this option if the data is sent to a
host and you do not require another backup from the
instrument.
• The Backup and Clear option saves the test results
on an external storage device, e.g., DVD. The test
results are deleted afterwards.
Downloading parameters from the data
manager
To ensure accurate measurements, you must keep all
parameters up-to-date. Parameters are lot-specific
application settings, calibrator data, QC material data, or
special wash data. The parameters are contained in the
corresponding file of the e-barcode.
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
10 Pre-routine tasks
The Parameter Download button indicates that new
parameters are available for download from cobas
®
link
via the data manager:
The color of the button indicates whether you must
perform at least 1 maintenance action.
• Yellow: Updated or new parameters are available for
installed applications.
• Red: Important parameters are required by the
instrument.
Steps User action
1
Enabling the preventive
actions
1. Choose the Overview tab and select the
Preventive Action check box.
2
Troubleshooting instrument
data alarms
1. Choose the Alarm button.
2. In the alarm list, choose an alarm.
o To remove the cause of the alarm,
perform the recommended remedial
action.
o To delete the alarm from the list,
choose the Delete button.
3. Close the alarm window.
3
Deleting the printer memory 1. Choose the Print > History tab.
2. Choose the Delete All button.
3. Choose the Yes button.
4. To close the dialog box, choose the Close
button twice.
4
Starting a maintenance
action manually
1. Choose the Overview > Daily
Maintenance button.
2. Choose the action you must perform.
o If you must perform a maintenance
action, choose it in the table on the
right.
3. Choose the Select button.
4. Choose the Execute button and follow the
instructions.
y Preparing the system
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cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
11
5
Clearing the sample database 1. On the control unit, insert an empty DVD
into the DVD drive.
2. Choose the Overview > Sample Data
Clear button.
3. Choose the Backup and Clear option and
confirm with the OK button.
4. On the Backup Data panel, choose the
backup type.
5. Enter a file name, for example, the current
date and choose the button.
6. Choose the OK button.
6
Downloading parameters
from the data manager
1. Choose the Parameter Download button.
2. Check the 4 tabs for available parameters.
3. Select the desired parameter and choose
the Download button.
4. Select the desired settings and choose the
OK button to start the download.
5. If you have downloaded new application
parameters, load the corresponding
reagent cassettes.
6. Calibrate the corresponding tests and
perform QC measurements.
7
Checking the Information
window on the data manager
1. To display detailed information, double-
click the item.
2. Start actions to solve the issue.
8
Deleting open orders
(weekly) on the data manager
1. Choose the cobas 8000 data manager
Routine > Sample overview component.
2. Define the time range.
3. Select the Results pending check box.
4. Choose the Apply button.
5. In the samples table, press Ctrl+A.
6. Right-click and choose the Delete
sample command.
7. Choose the OK button.
Steps User action
y Preparing the system
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
12 Pre-routine tasks
3. Loading reagents, system reagents, and consumables
Reagent preparation
The reagent load/unload list provides you with
information about which reagents and their amount are
required for a routine working day.
If the Reagent Preparing button is purple, yellow, or red,
some reagents on board are running short or are empty.
Load the reagents according to the reagent load/unload
list.
The color of the Reagent Preparing button indicates the
number of available tests or the remaining volume:
• Purple: Reagent below the amount of reagent for 1
day
• Yellow: Reagent below the defined warning level
• Red: Reagent empty or missing
Steps User action
1
Creating the reagent
load/unload list
1. Choose the Overview > Reagent
Preparing button.
2. Choose the Reagent Load/Unload List
button.
3. Close the panel.
4. Choose the Print > History tab.
5. Select the Reagent Load/Unload List file
and choose the Print Out > All > Print
Out button.
2
Loading reagents, system
reagents, and consumables
1. Prepare and load all reagents, system
reagents, and consumables according to
the reagent load/unload list.
o ISE module
o c 702 module
o c 701 module
o c 502 module
o e 801 module
o e 602 module
y Loading reagents, system reagents, and consumables
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
13
Loading on the ISE module
Ensure that the module is in Standby mode.
q The calibration interval is 24 hours for all ISE tests.
Product name Container type Position
ISE Internal Standard (IS) 1 container (2000 mL) Behind the front door
ISE Diluent (DIL) 1 container (2000 mL)
ISE Reference Electrolyte (REF) 1 container (500 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
ISE Standard Low Calibrator rack with primary tubes or
Sample Cups
Calibrator rack
ISE Standard High
PreciControl ClinChem Multi 1 (PCCC 1) QC rack with primary tubes or Sample
Cups
QC rack
PreciControl ClinChem Multi 2 (PCCC 2)
ECO-D
(a)
1 container (500 mL) Behind the front door of the ISE support
box
y System reagents for the ISE module
(a) ISE support box only
Steps User action
1
Replacing Sample Cleaner 1. In the Reagent > Status > ISE menu,
check the Sample Cleaner volume.
2. Open the module cover.
3. Replace required Sample Cleaner bottles.
4. Close the module cover.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
2
Replacing front door system
reagents
1. In the Reagent > Status > ISE menu,
check the following system reagent
volumes:
o IS
o DIL
o REF
2. Open the front door.
3. Replace required bottles.
4. Close the front door.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
y Loading reagents and system reagents on the ISE module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
14 Pre-routine tasks
3
Replacing ECO-D
(a)
1. Open the front door of the ISE support box.
2. From the empty ECO-D bottle, remove the
tubing.
3. Check the aspiration filter at the end of the
tubing and clean it if necessary.
4. Insert the aspiration tubing into the new
bottle and fasten the cap.
5. Put the new bottle back in place. Make
sure to place the bottle according to its
specified position.
6. Close the front door of the ISE support box.
7. Choose Reagent > Status.
8. From the Module drop-down list, choose
the ISE option.
9. Choose the changed reagent.
10. To reset the filling volume for countdown,
choose the Reagent Volume Reset
button.
4
Priming ISE reagents
(b)
1. Choose the Reagent Prime button.
o Enter the following settings:
ISE Module: ISE 1,2
Prime Item: All
Cycles: 20
2. Choose the Execute button.
(a) ISE support box only
(b) Not needed for ECO-D replacement
Steps User action
y Loading reagents and system reagents on the ISE module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
15
Loading on the c 702 module
Ensure that the module is in Standby mode.
Product name Container type Position
NaOH-D 1 container (1800 mL) Behind the front door
Cell Wash Solution II / Acid Wash 1 container (2000 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
ECO-D Reagent cassette On outer ring of reagent disk B only
NAOHD Reagent cassette On reagent disks A and B
SMS Reagent cassette
y System reagents for the cobas c 702 module
Steps User action
1
Replacing Sample Cleaner 1. In the Reagent > Status > c 702 menu,
check the Sample Cleaner volume.
2. Open the module cover.
3. Replace required Sample Cleaner bottles.
4. Close the module cover.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
2
Replacing front door system
reagents
1. In the Reagent > Status > c 702 menu,
check the following system reagent
volumes:
o NaOH-D
o Cell Wash Solution II
2. Open the front door.
3. Replace required bottles.
4. Close the front door.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
3
Removing empty
cobas c packs
1. If the green status indicator is on, open the
hatch door of the unloading tray and pull
out the drawer.
o The drawer must be fully opened.
Otherwise the system does not reset
the inventory of cobas c packs present
on the tray.
2. From the left lane, remove all empty
cobas c packs. The cobas c packs in the
right lane still contain reagents.
3. Move back the drawer and close the hatch
door.
y Loading reagents and system reagents on the c 702 module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
16 Pre-routine tasks
4
Loading cobas c packs via
reagent manager
1. Empty the cobas c packs cap drawer.
2. Choose one of the following loading
modes:
o BUFFER: The cobas c pack remains
on the buffer rotor until needed. The
system determines the loading time
and target reagent disk.
o AUTO: Loads the cobas c pack as
soon as possible. The system assigns
the target reagent disk. If the module is
in Standby, the reagent is loaded
immediately. During operation, the
reagent is loaded when the status
changes to Reagent Loading (S.Stop).
o A or B: Loads the cobas c pack as
soon as possible to disk A or B. If the
module is in Standby, the reagent is
loaded immediately. During operation,
the reagent is loaded when the status
changes to Reagent Loading (S.Stop).
3. If the status indicator is on, load
cobas c packs according to the reagent
load/unload list.
Steps User action
y Loading reagents and system reagents on the c 702 module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
17
Loading on the c 701 module
Ensure that the module is in Standby mode.
q For the c 701 module, you must unscrew the caps
from the reagent cassette manually with the
cobas c pack opener before you load it on the reagent
disk.
Product name Container type Position
NaOH-D 1 container (1800 mL) Behind the front door
Cell Wash Solution II / Acid Wash 1 container (2000 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
ECO-D cobas c pack On outer ring of reagent disk B only
NAOHD cobas c pack On reagent disk A and B
SMS cobas c pack
y System reagents for the cobas c 701 module
Steps User action
1
Replacing Sample Cleaner 1. In the Reagent > Status > c 701 menu,
check the Sample Cleaner volumes.
2. Open the module cover.
3. Replace required Sample Cleaner bottles.
4. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
2
Replacing front door system
reagents
1. In the Reagent > Status > c 701 menu,
check the following system reagent
volumes:
o NaOH-D
o Cell Wash Solution II
2. Open the front door.
3. Replace required bottles.
4. Close the front door.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
y Loading reagents and system reagents on the c 701 module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
18 Pre-routine tasks
3
Unloading/loading
cobas c packs
1. Open the reagent disk cover.
2. Remove empty cobas c packs according
to the reagent load/unload list.
3. Carefully unscrew the caps from the new
cobas c pack and insert it on the reagent
disk.
o The white part of the RFID tag must
face to the left. cobas c pack sets
must be placed on the same disk.
4. Close the reagent disk cover.
5. Close the module cover.
6. In the Reagent > Setting > c 701 menu,
choose the Reagent registration button.
Steps User action
y Loading reagents and system reagents on the c 701 module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
19
Loading on the c 502 module
Ensure that the module is in Standby mode.
Product name Container type Position
NaOH-D 1 container (1800 mL) Behind the front door
Cell Wash Solution II / Acid Wash 1 container (2000 mL)
Sample Cleaner 1 1 container (20 mL) Sample probe area
Sample Cleaner 2 1 container (20 mL)
ECO-D 1 container (59 mL)
NAOHD cobas c pack On reagent disk
SMS cobas c pack
y System reagents for the cobas c 502 module
Steps User action
1
Replacing Sample Cleaner 1. In the Reagent > Status > c 502 menu,
check the following system reagent
volumes:
o Sample Cleaner
o EcoTergent.
2. Open the module cover.
3. Replace required bottles.
4. Close the module cover.
5. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
2
Unloading empty
cobas c packs
1. Open the front door.
2. Remove all empty cobas c packs from the
drawer.
3
Replacing front door system
reagents
1. In the Reagent > Status > c 502 menu,
check the following system reagent
volumes:
o NaOH-D
o Cell Wash Solution II
2. Replace required bottles.
3. Close the front door.
4. Choose the Reagent Volume Reset
button for each replaced system reagent
bottle.
y Loading reagents and system reagents on the c 502 module
Roche Diagnostics
cobas® 8000 modular analyzer series · Version 2.1 · Quick Reference Guide ·
20 Pre-routine tasks
4
Loading cobas c packs 1. Open the reagent hatch door.
2. On the loading port, insert the new
cobas c packs according to the reagent
load/unload list.
o The barcode label must face to the
right.
3. Close the hatch door.
Steps User action
y Loading reagents and system reagents on the c 502 module
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