HumaCount 5D

| Quick Guide

PLEASE READ THE INSTRUCTION FOR USE BEFORE USING THE QUICK GUIDE

Cat No. 16450/5

REVISION LIST OF THE MANUAL
Rev. /DATE. REVISION DESCRIPTION
01/2021-04 First edition

SYSTEM VERSION

COPYRIGHT

Copyright 2021, Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden,
Germany.

All rights reserved. No part of this documentation may be reproduced in any form, nor
processed, copied or distributed by means of electronic systems, without prior permis-
sion of HUMAN in writing.
Since all precautionary measures were taken into account in producing these operating
instructions, the manufacturer accepts no responsibility for any errors or omissions.

This includes any liability for damage that could arise from possible incorrect operation
based on this information. Subject to changes without notice as result of technical de-
velopment.

SERVICE AND SUPPORT

TABLE OF CONTENTS

1 OPERATION 5

1.1 PREPARATION 5

1.2 STARTUP 5

1.3  BACKGROUND TEST 5

1.4  DAILY QUALITY CONTROL 6

1.4.1  Register a new QC lot 6

1.5  RUNNING SAMPLES - 3 MODES ARE AVAILABLE 9

1.6  SLEEP STATUS 10

1.7 SHUTDOWN 10

1.8 PRECAUTIONS 10

2  REAGENT MANAGEMENT 11

2.1 PREPARATION 11

2.2  LOADING REAGENTS 11

2.3  REAGENT MANAGEMENT 13

2.4 TROUBLESHOOTIG 14

3  CAPILLARY BLOOD MODE 15

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1  OPERATION

1.1  Preparation 1.2  Startup

Check and make sure: The reagents (HC5D
Diluent, HC5D CBC Lyse, HC5D Diff Lyse and
HC5D Clean) are sufficient and not expired;
the reagents and waste tubings are not bent;
the reagents are properly connected; the po-
wer cord of the analyzer is properly plugged.
1. Start the analyzer.
2. Enter user name and password, use admin for
both.
The startup initalization and cleaning procedures
begin. After the procedures, you can perform ope-
rations on the user interface.

1.3  Background test

Click Review and check whether the background results meet the following re-
quirements:

WBC ≤ 0.2 x 109/l RBC ≤ 0.02 x1012/l

HGB ≤ 1 g/l HCT ≤ 0.5% PLT ≤ 10 x 109/l

If the background results exceed the above ranges, the background abnormal error
will be displayed in the error message area. Click the area and click Remove Error to
remove the error. If the error still exists, contact our customer service department.

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1.4  Daily quality control

Before running samples every day, run the controls in the QC interface.

1.4.1  Register a new QC lot

1. From the main menu choose the QC. 2. Click QC Settings to enter the QC Settings interface.

3. Click the New button to register a new Lot of QC. 4. You can type in the target values according to the target value sheet of the
HC5D-Control. After entering the values click Save.

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5. Alternatively you can read the 2D barcode on the assay value sheet (optional 2D barcode reader (Ref.: 16430/11))
and automatically upload all target values into the analyzer.

A. Choose import and make sure the QR Code option is chosen. B. Scan the required QR Code level and wait until the values are entered completely.

C. Click on OK. Then you should see a message saying “Import Successful”. D. This Figure shows successfully uploaded QC Values from HC5D240L (Level L).

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6. Choose the new registered QC Lot under QC Settings by clicking on it. 7. Go back to the QC Results and introduce the HC5D-Control vial to the HC5D needle.
Push the aspirate key and wait until the measurement is finished.

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1.5  Running samples - 3 modes are available
Step Whole blood mode
(venous)
1 Click Mode&ID in the measure screen to set
the analysis mode.
1a Select
Venous Whole Blood (VWB)
1b Select the measurement mode CBC or C+DIFF
(which is 5-part Diff) as required.
1c Input the sample ID for the sample to be run.
2 Click OK.
3 Set the well-mixed sample (uncapped) below
the sample probe and press the aspirate key to
start the analysis. The analyzer runs the sam-
4 ple automatically.
5 Close the tube cap and invert the tube carefully
6 Uncap the bullet tube and present it to the

7 Remove the tube when you hear a beep.
! Note: The bullet tube (or centrifugal tube) shall be placed
vertically upward, not tilted or upside down.
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Predilute mode (out of range)
Click Mode&ID in the measure screen to set
the analysis mode.
Select
Predilute (PD)
Select the measurement mode CBC or C+DIFF
(which is 5-part Diff) as required.
Input the sample ID for the sample to be run.
Click OK.
Click Add Diluent on the menu screen, then
present a clean bullet tube (uncapped) under
the sample probe.
Click Cancel to exit the diluent dispensing.
Add 20 µl of blood.
to mix the sample.
sample probe so that the probe tip is vertical-
ly in contact with the bottom of the tube, then
press the aspirate key to start the analysis.
Remove the tube when you hear a beep.
Capillary blood mode (capillary)
Click Mode&ID in the measure screen to set
the analysis mode.
Select
Capillary Whole Blood (CTA)
Select the measurement mode CBC or C+DIFF
(which is 5-part Diff) as required.
Input the sample ID for the sample to be run.
Click OK.
Click Add Diluent on the menu screen, then
present a clean bullet tube (uncapped) under
the sample probe.
Click Cancel to exit the diluent dispensing.
Add 20 µl of capillary blood to the diluent.
Close the tube cap and invert the tube carefully
to mix the sample.
Uncap the bullet tube and present it to the
sample probe so that the probe tip is vertical-
ly in contact with the bottom of the tube, then
press the aspirate key to start the analysis.
Remove the tube when you hear a beep.
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1.6  Sleep status 1.7  Shutdown

- The analyzer enters the sleeping status automatically when there is no oper-
ations for a specified interval. You can still perform any operation not related
to the hydraulic unit at this time.
- When the analyzer is in the sleep state, you can touch the screen to wake it
up.
!
Note: Make sure to shut down the analyzer strictly as instructed on-screen,
and perform the shutdown maintenance with HC5D Clean.
1. Click on the menu screen, perform the shutdown procedure by following
the screen instructions.
2. Turn off the power switch of the analyzer.
3. Empty the waste container and dispose the waste properly.

1.8  Precautions

General environment
- Operating temperature: 15°C ~ 30°C
- Storage temperature: 5°C ~ 40°C
- Operating relative humidity: 20% ~ 85%

Troubleshooting
- If an error occurs, the message displays on the top of the interface. To re-
move the error, click the error message area, and then click Remove Error. For
details, see the Troubleshooting chapter in Operator‘s Manual.
- When the analyzer falsely shows an error message e.g. the diluent is running
out or waste is full, please take out the corresponding sensor from the con-
tainer, shake it 2 to 3 times and then put it back.
- Click Remove Error to remove the error. If the error still exists, contact our
customer service department.

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2  REAGENT MANAGEMENT
2.1  Preparation
Warning
- Reagents can be irritating to the eyes, skin and mucosa. Wear proper per-
sonal protective equipment (e.g. gloves, lab uniforms, etc.) and follow labo-
ratory safety procedures when handling them in the laboratory.
- If the reagent accidentally comes in contact with your skin, wash it off im-
mediately with plenty of water and see a doctor if necessary. Do the same if
you accidentally get any of the reagents in your eyes.
! Note: After long-distance transportation, the reagent must be allowed to
settle for more than one day before use.
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2.2  Loading reagents
Once an alert about insufficient reagent is displayed, you need to load and re-
place the respective reagent. Alternatively, when the reagent pack is low or close
to expiration, you can choose to change it immediately by clicking on the reagent
symbol located on the left side of the screen to access the reagent management
setting interface.
Here we will explain the process of loading new reagents using the example of
the HC5D Diluent. The same steps need to be performed for HC5D CBC Lyse and
HC5D Diff Lyse.
1. When the „HC5D-Diluent not enough.“ alert is displayed on the left side of
the screen, click the message. A dialogue box as shown in the following Fig-
ure will pop up.
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2. Connect a new container of HC5D-Diluent to the analyzer.
3. Take out the RF card from the inside of the new HC5D-Diluent container.
See the following Figure as a reference.
5. Place the RF card in front of the RF card reader symbol on the analyzer:
The beeping of the card reader and a pop up dialogue box as shown in the
following Figure indicate successful upload of reagent credits.
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4. Select the error name in the pop up dialogue box and click Remove Error. A
dialogue box as shown in the following Figure will pop up.
6. Click OK to complete the replacement of the reagent as shown in Figure 4.
The error will be removed automatically.
7. After replacement of the reagent, run a background test to verify that the
results meet the requirements.
Warning
Dispose of reagents, waste, samples, consumables, etc. according to local legis-
lations and regulations.
! Note:
• The RF card is intended for single use only. Mark the RF card as used.
• If the RF card verification fails, please follow the system prompts and use
a valid RF card.
• For the replacement of Lyses, cross-cut the seal of the bottles. Please be
careful to prevent sealing fragments from falling into the lyse bottles.
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2.3  Reagent management

Once the new reagent is connected to the analyzer, you can set the reagent configurations in the
Reagent Management interface as shown in Figure 5.

After completing the reagent settings, you should perform the reagent replacement operations.
You can select to replace one type of reagent at a time or all Reagents at once.

The procedure will be performed as follows:

- Select a type of reagent to be replaced, and click Replace; alternatively click Replace All to replace
all reagents.
- After the replacement is completed, a message box will pop up on the screen. See Figure 6.
- Click OK to close the message box.

! Note: After reagent replacement, run a background check to verify that the results
meet the requirements.

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2.4  Troubleshootig

Error description Solution

“Reagent name” not enough. Refer to chapter 2.2 Loading reagents.
e.g. „HC5D-Diluent not enough“

“Reagent name” expired 1. Check if the reagent is expired. If so, replace it with a new container.
e.g. „HC5D-Diluent expired“ 2. Click the error information on the left side of the screen. Click Remove Error in the pop-up dialogue box.
3. If the error still exists, contact our customer service department.

“Reagent name” running out 1. Check whether the reagent is running out. If so, please install a new container.
(or air bubbles in inlet tubing). 2. Click the error information on the left side of the screen. Click Remove Error in the pop up dialogue box.
e.g. “HC5D-Diluent running out. 3. If the error still exists, contact our customer service department
(or air bubbles in inlet tubing).“

! Note: After reagent replacement, run a background check to verify that the results meet the re-
quirements.

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3  CAPILLARY BLOOD MODE

1. 480 µl of HC5D- Diluent are automatically dispensed into a bullet tube by the 2. Click Mode&ID in the measuring screen and select Capillary Whole Blood
HC5D. (CTA) mode

3. Blood collection by finger prick, and 20 µl HUMAN capillary tube (EDTA coded). 4. Put the capillary into the bullet tube filled with Diluent, close the lid and in-
After blood collection is completed, wipe away excess blood on wet lint free vert the sample carefully, until the suspension is homogenous.
tissue. Avoid any contact of tissue and blood inside the capillary tube

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5. Put the capillary into the bullet tube filled with Diluent, close the lid and in- 6. Results of 29 parameters will be shown in the measuring screen.
vert the sample carefully, until the suspension is homogenous.

< <
- Open the lid, insert the bullet tube to the collection needle and press the big
red button to start the recording. Make sure the needle always touches the
bottom of the bullet tube.
- HC5D automatically draws demanded volume from the bullet tube.

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HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 • 65205 Wiesbaden • Germany
Tel.: +49 6122/9988 0 • Fax: +49 6122/9988 100
eMail: human@human.de • www.human.de