HemoCue WBC DIFF Operating Manual April 2019

Table of Content HemoCue® WBC DIFF System... 3 Components...4 Start-up...6 Symbols... 10 Navigation Symbols...10 Procedure Symbols...10 Display Symbols... 11

Set-up... 12 Settings...12 DIFF Flag Setting... 20 Printer & Connectivity...22 Keyboard & Barcode Reader...24

Blood Collection...26 Capillary Sample...26 Venous Sample and Control Material... 30

Routine Use...32 Patient Test...32 QC Test... 38

Review/Delete Results... 44 Maintenance... 48 Daily Maintenance... 48 Optical Parts... 50

Troubleshooting Guide...52 Specifications... 57

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HemoCue® WBC DIFF System

EN

Thank you for choosing the HemoCue® WBC DIFF System. The HemoCue WBC DIFF System is an In Vitro Diagnostic system designed for quantitative determination of white blood cells (WBC) in capillary or venous whole blood. The system provides values for a total white blood cell count and a differential white blood cell count including neutrophil count, lymphocyte count, monocyte count, eosinophil count and basophil count. The HemoCue WBC DIFF System is indicated for use in clinical laboratories and for point of care testing in professional health care settings on pediatric (≥ 3 months) and adult patients. The HemoCue WBC DIFF Analyzer is only to be used with HemoCue WBC DIFF Microcuvettes for measurement of a total white blood cell count and a differential white blood cell count or with HemoCue WBC Microcuvettes for measurement of a total white blood cell count only. Read and follow this operating manual and the HemoCue WBC DIFF Microcuvettes package insert and/or HemoCue WBC Microcuvettes package insert to attain optimum performance and safety. Any other use of the system than recommended by the manufacturer may impair the safety.

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Components

1

2

4

3

5a

5b

6

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1.

HemoCue WBC DIFF Analyzer

2.

Power adapter

3.

Six type C Alkaline batteries*

4.

HemoCue WBC DIFF Quick Reference Guide

5.

a. HemoCue WBC DIFF Microcuvettes* b. HemoCue WBC Microcuvettes*

6.

HemoCue WBC DIFF Operating Manual

Place analyzer and accessories on a rigid surface (non-vibrating). NOTE: Do not open the cover of the analyzer. The warranty is void if the cover of the analyzer is opened. *Not included

For infomation about HemoCue WBC DIFF Microcuvettes and HemoCue WBC Microcuvettes, please contact the HemoCue distributor.

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Start-up

1

2

3

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The analyzer can be powered by either adapter or batteries.

Connect the power adapter 1.

Plug the supplied power adapter into the power inlet at the back of the analyzer. Only use power adapters listed under Technical Specifications in section Specifications.

Insert Batteries 2.

Press the ribbed marked button on the back of the analyzer to open the battery compartment on the left side.

3.

Gently take out the battery unit. Insert six type C Alkaline batteries, 1.5 V. Observe the indication of polarity. Put the battery unit back in the analyzer.

Consult local environmental authorities for proper disposal of batteries.

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4

7

WBC DIFF

5

WBC DIFF

8

WBC DIFF

6

WBC DIFF

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Start the Analyzer 4.

Pull the cuvette moving arm out to loading position.

5.

Press and hold the left button until the display is activated. A start-up window shows analyzer software version for approximately 15 seconds.

6.

The analyzer performs a self-test and the hourglass is shown for approximately 30 seconds.

7.

The analyzer is ready for use when the main menu is shown. The three buttons below the display are for navigating and confirming the choices/symbols displayed above each button. Additionally, external keyboard* and barcode reader* can be used for data entry. The keyboard can also be used for navigation. For installation see section Set-up/Keyboard & Barcode Reader.

Turn off the Analyzer 8.

Press and hold the left button until the display goes blank. The analyzer will automatically turn off when not in use: • after 5 min with battery supply • after 8 hours with power adapter

* Must be purchased separately

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Symbols Navigation Symbols

Designation

Function

Home

Procedure Symbols

Designation

Function

Go to main menu.

Patient Test

Go to Patient Test procedure.

Right

Continue to next number/ window.

Menu

Go to “Menu” window for Review/Delete/Settings/QC test.

Left

Return to previous number/ window.

Review/Delete

Go to “Review/Delete menu” window.

Up

Scroll up.

Review

Go to “Review” window.

Down

Scroll down.

Delete

Go to “Delete Results” window.

Accept

Accept input.

Settings

Go to settings menu.

Reject

Reject input.

Switch

Jump between result and data.

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Display Symbols

Designation

Function

Connected

Designation

Function

Analyzer connected to a PC application.

Remove Cuvette

Pull the cuvette moving arm to loading position and remove the microcuvette.

Unsent Results

Unsent results stored in the analyzer.

Measuring

Measuring.

Accepted

Accepted result. Hourglass

The analyzer performs a self-test.

Page Number

Current page number/total amount of pages.

Flag

The results for the WBC differential count are uncertain. The sample may contain pathological, abnormal or unidentified cells (see Troubleshooting Guide section). A print-out will show asterisks (*) instead of the display symbol

Non-critical Error

An error has occurred. See Troubleshooting Guide section.

Critical Error

A critical error has occurred. See Troubleshooting Guide section.

Rejected

Rejected result.

Auto Accepted

Auto accepted result.

Battery Level

Critical battery level.

Battery Level

Battery level 30%. Battery level indicates 10-100%.

Power adapter

Analyzer connected with power adapter.

Insert Cuvette

Analyzer ready for measurement. Insert a microcuvette to start measuring.

Display Symbols

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Set-up

Settings

1

WBC DIFF

2

WBC DIFF

3

WBC DIFF

4

WBC DIFF

5a

WBC DIFF

5b

WBC DIFF

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Settings are made in the Set-up/Settings menu. Use the left button to confirm/accept input and move backwards. Use the right button to confirm/accept input and move forward. The center button scrolls up/downwards and ticks boxes. 1.

Turn on the analyzer as described in the Start-up section.

2.

Press the right button.

3.

Press right button to choose menu and move to next window.

4.

Enter PIN Code window is shown. The Pin Code is used to prevent unauthorized users from entering/changing input in the settings menu. As default, the PIN Code is set to 0000. For change of PIN Code see step 19, Settings section. Enter the PIN code by pressing the center button to change digit. Press right button to confirm the input and move to the next. After entering the four digit PIN Code press right button to accept and move to next window.

5.

If the analyzer is configured for USB - window 5a is shown. If the analyzer is configured for ethernet - window 5b is shown. The display shows: Home, Review/Delete and Settings. Press the right button to enter Settings.

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6

WBC DIFF

7

WBC DIFF

8

WBC DIFF

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WBC DIFF

10

WBC DIFF

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WBC DIFF

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6.

Language set up window is shown. Select language by pressing the center button. Press right button to confirm and move forward.

7.

Time Zone window is shown. Select Time Zone input by pressing the button below the up arrow. Press the right button to confirm and move forward.

8.

Date Format window is shown. Select Date format by pressing the button below the down arrow. Press right button to confirm and move forward.

9.

Date input window is shown. Select Date input by pressing the button below the up arrow to change numbers. Press right button to confirm and move to next number. Press right button to confirm and move forward.

10. Time Format window is shown. Select Time format by pressing the button below the down arrow. Press right button to confirm and move forward. 11. Time input window is shown. Set hours by pressing the button below the up arrow. Press right button to confirm the input and move to minutes. Press right button to confirm and move forward.

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12

WBC DIFF

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WBC DIFF

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WBC DIFF

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12. Patient ID window is shown. Select Patient ID on/off by pressing the button below the up arrow. Press right button to confirm and move forward. 13. Operator ID window is shown. Select Operator ID on/off by pressing the button below the up arrow. Press right button to confirm and move forward. 14. Lab ID window is shown. Select Lab ID on/off by pressing the button below the up arrow. Press right button to confirm and move forward. 15. Site ID window is shown. Select Site ID on/off by pressing the button below the up arrow. Press right button to confirm and move forward. 16. Control ID window is shown. Select Control ID on/off by pressing the button below the up arrow. Press right button to confirm and move forward.

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WBC DIFF

18

WBC DIFF

20

WBC DIFF

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WBC DIFF

19

WBC DIFF

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17. Unit window is shown. The results can be presented in • absolute numbers together with percentage; 109/L, % • absolute numbers only; 109/L • percentage only; % Select how to present the result by pressing the button below the down arrow. Press right button to confirm and move forward. 18. Audio Signal window is shown. A soft signal is heard when buttons are pressed, one short signal is heard when a test is ready and a distinct signal is heard when an error has occurred. Select Audio Signal on/off by pressing the button below the up arrow. Press right button to confirm and move forward. 19. PIN Code Setting window is shown. Change digits by pressing the button below the up arrow. Press right button to confirm and move to next digit. Press right button to accept the four digit PIN Code. 20. If the PIN Code is changed the Verify Change of PIN Code is shown. Press right button to accept the change. Press left button to reject the change. 21. Main menu is shown.

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Set-up

DIFF Flag Setting

1

WBC DIFF

2

WBC DIFF

3

WBC DIFF

4

WBC DIFF

5

WBC DIFF

6

WBC DIFF

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