cobas u 411 ST analyzer

Installation and Training Manual

 General Information

The contents of this manual, including all graphics and photographs, are the property of Roche Diagnostics.
No part of this document may be reproduced or transmitted in any form or by any means, electronic or
mechanical, for any purpose, without the express written permission of Roche Diagnostics.
Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes
necessary without notice as part of ongoing product development.
The information contained in this training manual are for training purposes only and do not replace,
supercede or add in any way to the information contained in the cobas u 411 analyzer Sediment Terminal
Operator’s Manual and Customer Bulletins.

This training guide was created by the Roche Diagnostics Technical Publications department. Direct
questions or concerns regarding the contents of this document to:
Roche Diagnostics
Technical Publications Department
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COBAS and COBAS U are trademarks of Roche. All other trademarks are the property of their respective
owners.
© 2010, Roche Diagnostics.
US Order Number: 05363713001
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This installation manual is printed in the US.
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Revision History

Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document
may be reproduced in any form or by any means without prior written consent.

Publication Date Revision purpose

Reference Number

05363713001 March 2010 document creation

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ii cobas u 411 ST analyzer Installation and Training Manual

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 General Information

Table of Contents

Section 1 - Component Overview

Hardware Identification .................................................................................................................................1
Keypad Identification .....................................................................................................................................2

Section 2 - Installation
Connect Sediment Terminal ..........................................................................................................................5
Program Sediment Parameters and Ranges ..................................................................................................6
Enable Sediment Terminal .............................................................................................................................7
Select Type of Sample for Sediment Entry ....................................................................................................8

Select Sample Entry Mode ..............................................................................................................................8

Print Sediment Parameters and Ranges .........................................................................................................9

Section 3 - Routine Operation

Enter Sediment Parameters ..........................................................................................................................11
Print Sample Results .....................................................................................................................................14

Section 4 - Review
Review Questions ..........................................................................................................................................15
Review Answers .............................................................................................................................................16

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Component Overview

The Sediment Terminal (ST) is an optional peripheral device that connects to the cobas u 411 analyzer.
The ST allows you to enter the programmed ranges for sample sediment evaluation results and collate these
results with the sample test strip results.

I. Hardware Identification

D
C

A Display
• Two line LC display screen

B Membrane keypad
• Keypad used to configure the ST and enter patient sediment parameters

C Type Plate
• Contains the serial number of the ST

D Serial Interface
• Used to connect the ST to the cobas u 411 urine analyzer

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II. Keypad Identification

Home
• Displays the number of strips processed and the number of strips flagged as Sieve Positive.
• Calls up the Main Menu.

View
• Used to select the sample for sediment entry and displays the test strip results of that sample.
The ST can be setup to select samples by Sample ID, sequence number or from the Work list.

Next
• Saves the selected sediment parameters for the displayed sample.
• If in Work list mode, the Next button allows you to scroll through the samples in the Work list.

Parameter
• Press to select one of the three sediment parameter groups. An LED illuminates to indicate which
group is selected.
• Green LED – Group I
• Yellow LED – Group II
• Red LED – Group III
• Each group can have up to 10 sediment parameters each having up to five reportable ranges
programmed. This allows a total of 30 sediment parameters available.

Mode
• Allows you to choose whether all samples or only Sieve flagged samples are available for sediment
entry.
• Also used to choose the method for sample entry.
• The Mode item selected is marked with an asterisk (*).
• Mode is active only in the Main Menu.

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II. Keypad Identification

Numerical Keypad
• Use to type the Sample ID or Sequence Number during sample entry.
• Also used to call in and display the desired sediment parameter from the selected parameter group.

Enter
• Press either of these buttons to confirm the entry of the Sample ID or Sequence number.
• Also use the Enter buttons to select the next higher reportable concentration range for the selected
sediment parameter.

Clear/Cancel
• Press this button to clear the typed Sample ID or Sequence number.
• This button can also be used to clear the concentration displayed for the selected sediment
parameter. Once cleared, you can select the Enter to scroll to the desired concentration.
• Press this button if no microscopic result is entered for the sample. This also prints the sample
report and automatically displays the next available sample in the Work list (if Work list is the
Sample Entry Mode selected).

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Installation

I. Connect Sediment Terminal to cobas u 411 analyzer

1) Log off the cobas u 411 analyzer.

2) Touch Shutdown and power off the cobas u 411 analyzer.

3) Unpack the Sediment Terminal box that contains the Sediment Terminal and a 1.5 meter serial
cable.

Sed-Terminal
Connection

ST Serial Interface

4) Connect the male 9-pin connector of the serial cable to the Sed-Terminal connection located on the
back of the cobas u 411 analyzer.

5) Connect the other end of the serial cable to the Sediment Terminal (ST) Serial Interface located on
the back of the ST.

6) Power ON the cobas u 411 analyzer.

Note: Since no sediment parameters exist, an alarm message is generated on the cobas u 411
analyzer. Press the cobas u 411 analyzer Alarm button, then touch to close the screen.

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II. Program the Sediment Parameters and Ranges on the cobas u 411 analyzer

1) Log on to the cobas u 411 analyzer with Supervisor Rights.

• Touch a login Name with Supervisor password level.

• Enter the required Password.
• Touch .

2) Touch Utilities, then Sediment Parameters.

3) Select the first available Parameter No. line and enter the name of the sediment parameter.

Note: The button allows you to enter alphanumeric

characters. Up to 10 characters can be selected.

From line 1-10, enter the most frequently seen sediments. These are registered as Parameter Group I.
From line 11-20, enter the less frequently seen sediments. These will form Parameter Group II.
From 21-30 is Parameter Group III, the infrequently seen sediment parameters.

4) Touch to save entry.

5) Touch to define up to five concentration ranges for the displayed sediment parameter.

6) Highlight the first available Range No. line and enter the concentration range using the keypad.

Note: When viewing the alphanumeric keypad, the

(ASCII) button allows you to select special characters
including > and +.

7) Repeat step 6 to enter all necessary ranges for the displayed sediment parameter, then select .

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II. Program the Sediment Parameters and Ranges on the cobas u 411 analyzer, continued

8) Repeat steps 3-7 to enter the remaining Sediment Parameters and Ranges.

9) If necessary, manually record the information from the Sediment Parameters screen onto the
cobas u 411 analyzer Quick Reference Card. This may help when entering sediment parameters for
samples. A printout can also be generated. Refer to step V for directions in obtaining the sediment
parameters printout.

10) Select to save the defined parameters and close the screen.

III. Enable the Sediment Terminal

1) Touch Utilities tab in the cobas u 411 analyzer.

2) Touch System Parameters and System Parameters 2.

3) Touch Sed. Terminal.

4) Touch to power ON the Sedimant Terminal.

5) Touch to save changes.

6) Touch to exit System Parameters screen.

Note: If the Sedimant Terminal is powered OFF, it is inactive but still connected to the analyzer.

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IV. Select the Type of Samples available for sediment entry

1) Press Home on the ST.

The * denotes the option
2) Press Mode. currently selected.

Sediment entry mode: Work list

7 = ENTRY MODE 8 = ALL* 9 =SIEVE POS.

3) Select the types of samples that are available for sediment entry:

• Press 8 on the ST keypad to select all samples.

• Press 9 on the ST keypad to select only samples that generate a Sieve flag (S).

V. Select the Sample Entry Mode

1) Press 7 to display the Entry Mode selections. The * denotes the option
currently selected.

Sediment entry mode:

7 = SAMP ID 8 = SEQ. NO. 9 =WORK LIST*

2) Select the Sample Entry Mode:

• Press 7 to select samples by Sample ID.

• Press 8 to select samples by Sequence Number.
• Press 9 to select samples from the Work list.

3) Press the Home button.

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VI. Print and store the programmed Sediment Parameters and Ranges

1) Touch the Utilities tab, then Tools on the cobas u 411 analyzer.

2) Touch Data Exchange.

3) Touch .

4) The sediment parameters and ranges are listed at the bottom of the printout.
Note: Refer to this when entering the sediment information for samples. This information can
also be manually recorded on the cobas u 411 analyzer Quick Reference Card.

5) Touch Store Config. to store the configured system, test and sedimant parameters on the USB stick
that could be loaded into a cobas u 411 analyzer. Use the USB stick (memory stick) that contains
Operating System and User Software that comes with the analyzer.

6) Follow the prompt message “Please enter an USB stick first!”

7) Touch .

8) Touch to close the Tools screen.

9) Remove the USB stick from the USB port and store it in a safe place for future essential
troubleshooting.

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Routine Operation

I. Enter sediment parameters for a selected sample

1) Press the Home button on the ST keypad to display the number of samples that were measured

and the number of samples that are flagged with an S.

S E D I ME NT E NT R Y

9 Strips Measured 5 sieve pos.

2) Press the View button to select the sample.

• The sample entry option selected in the Mode button determines which screen is displayed.
• We will discuss the steps required to enter sediment parameters for each mode.
• The example sample we will program is sequence number 10 with a sample ID of 12345.
a. Sample ID entry mode
1) Type the Sample ID using the number keypad.
2) Press the Enter button on the keyboard.

Enter samp ID:

Note: The barcode scanner cannot be used to enter the Sample ID. The Sample ID
must be entered manually using the keypad.

b. Sequence Number entry mode

1) Type the sequence number of 10 using the number keypad.
2) Press the Enter button on the keyboard.

Enter seq. no:

c. Work list entry mode

Note: The first sample on the cobas u 411 analyzer Work list is displayed.
1) Press the Next button until the desired sample is displayed.

Seq. no: 10 Sampl ID: 12345

SG: 10 pH: 6+ L: 25

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I. Enter sediment parameters for a selected sample continued

3) Once the sample is selected, a screen is displayed that summarizes the test strip results generated
for that sample.
If a + is next to the pH, add 0.5 to the result.
In this example the pH generated was 6.5.

Seq. No: 10 Sampl ID: 12345

SG:10 pH: 6+ L: 25

The last two digits of the Specific

Gravity results are displayed.
The actual SG result for this Results flagged as Sieve are
displayed here. In this example
sample is 1.010.
the Leukocyte value was 25/μL

4) Press the Parameter button on the ST keyboard until the required parameter group LED is

illuminated.
Note: Refer to the parameter printout or the cobas u 411 analyzer Quick Reference Card for
the necessary Group number.

In this example, press the Parameter button until the green LED is illuminated
allowing us to enter the sediment parameters that are programmed in Group 1.
Green LED
Yellow LED
Red LED

5) Select the sediment parameter number within the chosen group.

In our example, enter the Leukocyte sediment parameter which is configured as
parameter number 3 in Group 1. Press 3 on the keyboard and the name of the
parameter, Leu, is displayed.

Seq. no: 10 Sampl ID: 12345

Leu:

Note: You can enter 1-9; 0 for the parameters (0 selects the parameter number 10, 20, or
30, depending on the selected parameter group).

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I. Enter sediment parameters for a selected sample continued

6) Press the Enter button until the desired concentration range is displayed for the sediment
parameter.
In this example, select the 1-5 range which is programmed as the second range for
Leucocytes. Press the Enter button two times.

Seq. no: 10 Sampl ID: 12345

Leu: 1-5

Note: If you need to display a lower concentration range, select the C button on the
keypad to clear the display. Select Enter until the desired range is displayed.

7) Press the number of the next sediment parameter and then select Enter until the correct
range is displayed.
Note: If the parameter is contained within a different group, press the Parameter
button until the correct group LED is illuminated.
For our example, enter a Bacteria result of +. This Bacteria result is programmed in
Group II, parameter number 12 and the first range concentration. Perform the following
steps:
• Press Parameter button to illuminate the yellow Group II LED.
• Press the number 2 to select the Bacteria parameter.
• Press the Enter button once to display the + concentration range.

Seq. no: 10 Sampl ID: 12345

Leu: 1-5 Bacteria: +

The previously entered sediment

parameter is displayed.

8) Once all parameters and ranges are entered, press Next to display the next sample on the
list. This also prints the sample results.
9) Repeat the above steps for the remaining samples.
Note: If no sediment parameter is entered for the sample, press C to print the final sample
result and automatically display the next sample in the work list.

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II. Print sample results

If All, Sieve or Sieve and Abnormal samples are set up to print in the Overview tab of the cobas u 411
analyzer, a collated printout containing the sediment and test strip results automatically prints after
each sample sediment entry is completed.
If the results do not automatically print, refer to the steps below to generate a printout.
1) Touch the Workplace tab on the cobas u 411 analyzer.
2) Touch Sample List, then .
3) Enter the sample Sequence numbers in the From and To that you want to print.

4) Touch .

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Review Questions

1. How many Sediment Parameter Groups are available to be defined/configured?

2. How many Sediment Parameters can each Parameter Group have?

3. What are the three Sample Entry Modes that can be selected from the ST?

4. When entering a sediment parameter, what number in the keypad designates 10, 20 or 30 depending on
the Parameter Group selected?

5. Which button do you use to display the range concentration of a sediment parameter?

6. Once all sediment entry is completed for the sample, which button must be pressed to save entry, print
out result and display the next sample to be processed (if using Work list as the Sample Entry mode)?

7. List the steps on how to power off the Sediment Terminal from the cobas u 411 analyzer.

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Review Answers

1. How many Sediment Parameter Groups are available to be defined/configured?

3 groups

2. How many Sediment Parameters can each Parameter Group have?

10 sediment parameters for a total of 30

3. What are the three Sample Entry Modes that can be selected from the ST?
Sample ID
Sequence No.
Work list

4. When entering a sediment parameter, what number in the keypad designates 10, 20 or 30 depending on
the Parameter Group selected?
0 or zero

5. Which button do you use to display the range concentration of a sediment parameter?
Enter key

6. Once all sediment entry is completed for the sample, which button must be pressed to save entry, print
out result and display the next sample to be processed (if using Work list as the Sample Entry mode)?

Next

7. List the steps on how to power off the Sediment Terminal from the cobas u 411 analyzer.
Utilities > System Parameters > System Parameters2 > Sediment Terminal > then < > key

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