cobas b 101 systemQuick Reference Guide cobas b 101 systemQuick Reference Guide

Protection against infection• Follow your institution‘s infection control procedures for handling blood specimens.• There is a potential risk of infection. Healthcare professionals using the cobas b 101 system must be aware that

any object coming into contact with human blood is a potential source of infection. Healthcare professionals must also be aware that any cross-contamination is a potential source of infection for patients.

Refer to the cobas b 101 system Operator’s Manual and cobas HbA1c or Lipid disc inserts for detailed information.

Important safety information

WARNING

This quick reference guide is not intended as an alternative to reading the operator’s manual. Please read the cobas b 101 system Operator’s Manual carefully before using the instrument for the first time.

For all questions about cobas b 101 system that are not answered in the quick reference guide, operator’s manual or package inserts, contact your Roche representative.

To find your Roche contact details1 Visit our website at www.roche.com.2 Choose “Roche Worldwide” at the top of the page.3 Choose your country to find the appropriate local office contact information.

MaterialsYou need the following materials to perform patient and control tests:• HbA1c disc• Lipid disc• cobas HbA1c Control kit• cobas Lipid Panel Control kit• HbA1c QC Info disc and Lipid QC Info disc• Optical Check disc

The cobas b 101 system is intended for professional use in a clinical laboratory setting or at the point of care. The instrument can be configured according to your institution’s needs, and features such as requiring an operator ID may or may not be used.

If so configured, the cobas b 101 system prevents patient testing when controls have not been run (QC lockout).

QC lockout occurs when• Patient testing is attempted and controls have not been run in the time interval or frequency designated by your

institution.• Controls have been run but the control values were outside the permitted range.

Error messages are displayed to alert you to a condition that needs attention. Take the action suggested on the screen, select , and proceed with testing.

General information

1 Lid. Use the “Open” button on the screen e.g. to insert a test disc for measurement. Keep this flap closed during measurement.

2 Touchscreen. Shows buttons, icons, information, and test results. To use a function, tap the button on the screen lightly.

3 Power on/off switch.

4 Lid button. Use this button to open the flap when the instrument is switched off.

5 DC IN 12 V terminal. Connect the power cable from the power adapter to supply 12 V DC power to the instrument.

6 BUH terminal. Connection to a network through a Base Unit Hub.

7 USB 1 terminal. Connection to a personal computer.

8 Bar code scanner terminal.

9 USB 2 terminal. Connection to USB memory stick or a printer.

cobas b 101 system

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1 Front view of HbA1c disc.

2 Back view of HbA1c disc.

3 HbA1c disc suction point.

4 HbA1c QC Info disc.

5 Front view of Lipid disc.

6 Back view of Lipid disc.

7 Lipid disc suction point.

8 Lipid QC Info disc.

cobas b 101 system – disc overview

LipidQC Info Disc

HbA1cQC Info Disc

LipidHbA1c

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5 6

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6

Single Test HbA1c

Sin

gle

Test

HbA

1c

Single Test HbA1c

Sin

gle

Test

HbA

1c

Single Test HbA1c

9 With the front of the disc facing upwards, position the disc’s suction point above the drop of blood.

11 Check the sample volume: turn the disc on its backside. The area marked in blue has to be filled completely with blood.

10 Apply blood and observe that it has filled the marked area.

12 Press hinge cover down firmly to close disc.

HbA1cHbA1c

HbA1c

3 Open disc pouch and remove HbA1c disc.

4 Open disc completely.

HbA1c

Hb

A1c

1 Power on instrument. 2 Select Patient Test and then select Single Test.

HbA1c

5 Front view of HbA1c disc.

6 Back view of HbA1c disc.

A Suction Point: Apply blood here.

7 Clean the side of the middle or ring finger with an alcohol swab and dry with sterile gauze.

8 Lance the side of the fingertip. Wipe away the first drop of blood.

A

13 Once closed correctly…

15 Open the lid by selecting Open on the screen.

14 …the hinge cover cannot be opened again.

16 With the disc facing upwards, place it on the spindle within the white circle.

17 Close lid. The measurement starts automatically and takes about 5 minutes.

18 Finish test by selecting on the screen

and dispose of disc appropriately.

* If alarm is enabled.

17 18

Single Test Lipid

Sin

gle

Test

Lip

id

Single Test Lipid

Sin

gle

Test

Lip

id

Single Test Lipid

1 Power on instrument. 2 Select Patient Test and then select Single Test.

3 Open disc pouch and remove Lipid disc.

4 Open disc completely.

Lipid

11 Check the sample volume: turn the disc on its backside. The area marked in blue has to be filled completely with blood.

12 Press the hinge cover down firmly to close disc.

Lipid

9 With the front of the disc facing upwards, position the disc’s suction point above the drop of blood.

10 Apply blood and observe that it has filled the marked area.

LipidLipid

5 Front view of Lipid disc. 6 Back view of Lipid disc.

A Suction Point: Apply blood here.

Lipid

7 Clean the side of the middle or ring finger with an alcohol swab and dry with sterile gau�e.

8 Lance the side of the fingertip. Wipe away the first drop of blood.

A

13 Once closed correctly…

15 Open the lid by selecting Open on the screen.

14 …the hinge cover cannot be opened again.

16 With the disc facing upwards, place it on the spindle within the white circle.

Lipid

Lipid

Lip

id

17 Close lid. The measurement starts automatically and takes about 6 minutes.

18 Finish test by selecting on the screen

and dispose of disc appropriately.

* If alarm is enabled.

Dual Test

Dua

l Tes

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Dual Test

Dua

l Tes

t

Dual Test

1 Power on instrument. 2 Select Patient Test and then select Dual Test.

3 Read on-screen instructions carefully and confirm by selecting .

4 Open disc pouch and remove Lipid disc.

9 Lance the side of the finger. Wipe away the first drop of blood.

12 Check sample volume: The area marked in blue has to be filled completely with blood.

10 With the front of the disc facing upwards, position the disc’s suction point above the drop of blood.

11 Apply blood and observe that it has filled the marked area.

LipidLipid

5 Open disc completely. 8 Clean the side of the middle or ring finger with an alcohol swab and dry with sterile gauze.

Lipid

Lipid

6 Front view of Lipid disc. 7 Back view of Lipid disc.

A Suction Point: Apply blood here.

A

14 Put Lipid disc aside.

Lipid

13 Press the hinge cover down firmly to close disc. Once closed correctly the hinge cover cannot be opened again.

15 Open pouch of disc and remove HbA1c disc.

16 Open disc completely.

HbA1c

Hb

A1c

22 Open the lid by selecting Open on the screen. Insert HbA1c disc immediately.

23 Close lid. The measurement starts automatically and takes about 5 minutes.

24 Wait for message ‘HbA1c Test completed’. Open lid. Remove HbA1c disc.

* If alarm is enabled.

HbA1c

21 Press the hinge cover down firmly to close disc. Once closed correctly the hinge cover cannot be opened again.

20 Check sample volume: Turn the disc on its backside. The area marked in blue has to be filled completely with blood.

HbA1c

17 Front view of HbA1c disc.

18 Back view of HbA1c disc.

A Suction Point: Apply blood here.

19 Apply blood directly to the disc from previously lanced finger, make sure the blood has filled the marked area.

HbA1c

A

25 Insert Lipid disc immediately. Close lid. The measurement starts automatically and takes about 6 minutes.

26 HbA1c and Lipid test results are displayed.

* If alarm is enabled.

27 Finish test by selecting on the screen

and dispose of disc appropriately.

Lip

id

QC Test HbA1c

QC

Tes

t H

bA1c

QC Test HbA1c

QC

Tes

t H

bA1c

QC Test HbA1c

HbA1c

HbA1c

1 Material needed:2 HbA1c discs …

3 Power on instrument.

HbA1cQC Info Disc

2 1 QC solution level 1 1 QC solution level 2 1 HbA1c QC Info disc.

4 Select Control Test and then select QC Test.

9 Close instrument lid. The QC information will be saved on the system.

10 Target value and target value range are displayed. Validate by selecting .

11 Select level of QC test (Level 1 or 2).

12 Open disc pouch and remove HbA1c disc.

HbA1c

HbA1cQC Info Disc

6 For new QC lot: Take HbA1c QC Info disc from the QC solution kit.

5 For a new QC lot select New QC Lot. Previously tested QC lots can be selected via lot button in display.

7 Open the lid by selecting Open on the screen and follow the on screen instructions.

8 Place QC Info disc on spindle within the white circle.

13 Open disc completely and turn disc on its backside (blank side facing up).

14 Carefully apply a drop of QC solution (level as defined in 11) to the suction point.

15 Check sample volume: The area marked in blue has to be filled completely with QC solution.

Hb

A1c

HbA1c

16 Press the hinge cover down firmly to close disc. Once closed correctly the hinge cover cannot be opened again.

21 Open lid by selecting Open on the screen, remove first HbA1c disc, insert second HbA1c disc, and close lid.

22 Verify that the QC solution lot number matches the lot num-ber displayed on the screen. Select to begin the mea-surement.

23 When measurement is complete the results of both levels (1+2) are displayed.

* If alarm is enabled.

24 Finish test by selecting on the screen

and dispose of discs appropriately.

17 Open lid, remove HbA1c QC Info disc, insert HbA1c disc and close lid.

18 Verify that the QC solution lot number matches the lot number displayed on the screen. Select to begin the measurement.

19 When measurement is complete, select to proceed with the QC test of the other level.

20 Open disc pouch and remove second HbA1c disc. Repeat procedure shown in steps 14-16.

HbA1c

QC Test Lipid

QC

Tes

t Li

pid

QC Test Lipid

QC

Tes

t Li

pid

QC Test Lipid

Lipid

Lipid

1 Material needed:2 Lipid discs …

3 Power on instrument.

LipidQC Info Disc

2 1 QC solution level 1 1 QC solution level 2 1 Lipid QC Info disc.

4 Select Control Test and then select QC Test.

9 Close instrument lid. The QC information will be saved into the system.

10 Target value and target value range are displayed. Validate by selecting .

11 Select level of QC test (Level 1 or 2).

12 Open disc pouch and remove Lipid disc.

LipidQC Info Disc

6 For new QC lot: Take Lipid QC Info disc from the QC solution kit.

5 For a new QC lot select New QC Lot. Previously tested QC lots can be selected via lot button in display.

7 Open the lid by selecting Open on the screen and follow the on screen instructions.

8 Place QC Info disc on spindle within the white circle.

13 Open disc completely and turn disc on its backside (blank side facing up).

14 Carefully apply a drop of QC solution (level as defined in 11) to the suction point.

Lipid

Lipid

16 Press the hinge cover down firmly to close disc. Once closed correctly the hinge cover cannot be opened again.

21 Open lid by selecting Open on the screen, remove first Lipid disc, insert second Lipid disc, and close lid.

22 Verify that the QC solution lot number matches the lot number displayed on the screen. Select to begin the measurement.

24 Finish test by by selecting on the screen and dispose of disc appropriately.

Lip

id

23 When measurement is complete the results of both levels (1+2) are displayed.

* If alarm is enabled.

15 Observe that the drop of QC solution is completely absorbed by the disc. The area marked in blue has to be filled completely with the clear solution.

17 Open lid by selecting Open on the screen, remove QC Info disc, insert Lipid disc, and close lid.

18 Verify that the QC solution lot number matches the lot number displayed on the screen. Select to begin the measurement.

Lip

id

19 When measurement is complete, select to proceed with the QC test of the other level.

20 Open disc pouch and remove second Lipid disc. Repeat procedure shown in steps 14-16.

cCOBAS, COBAS B and LIFE NEEDS ANSWERS are trademarks of Roche.

Manufactured in Japanfor Roche Diagnostics GmbH

©2012 Roche Diagnostics. All rights reserved.

Roche Diagnostics GmbHSandhofer Strasse 11668305 MannheimGermany

www.cobas.com 0 66

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