HumaClot Pro

| Quick Guide

PLEASE READ THE INSTRUCTION FOR USE BEFORE USING THE QUICK GUIDE

Cat No. 15800/5

REVISION LIST OF THE MANUAL
Rev. /DATE. REVISION DESCRIPTION
01/2015-09 First edition
02/2015-12 Update Maintenance & QC
03/2016-06 Update Software 1.1
04/2017-09 Update Maintenance sheet
05/2017-10 Correction typing errors
06/2018-04 Update Software 1.2
07/2019-07 Update Software 2.0
08/2019-08 Minor Corrections

SYSTEM VERSION

COPYRIGHT

Copyright 2019, 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 permission 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 development.
CONTENTS

TABLE OF CONTENTS

1  START UP 7

2  DAILY MAINTENANCE 8

3  LOAD CUVETTES CREDITS 11

4  LOAD/REPLACE CUVETTES 12

5  SET REAGENT LOT 13

6  LOAD REAGENT 14

7 CALIBRATION 15

8  SETUP QC 17

9  ENTER QC LOT DATA (REPEAT THIS FOR EVERY CONTROL) 18

10  LOAD QC 19

11  LOAD SAMPLE 20

12 MEASURE 21

13  FLAG OVERVIEW 22

14  UNLOAD SAMPLE 23

15  UNLOAD REAGENT 24

16  WEEKLY, MONTHLY AND YEARLY MAINTENANCE 25

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Start up 7

1  START UP PLEASE READ THE INSTRUCTION FOR USE BEFORE USING THE QUICK GUIDE

1. Fill distilled water 2. Empty waste

3. Switch on 4. Wait until Selftest finished successfull

3
8

2  DAILY MAINTENANCE

Start of the day

1. Press Perform 2. Place cleaner to W2 position 3. Press OK

Wait until clean cycle is finished
2

1 3

4. Remove cleaner from W2 position

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Daily Maintenance 9

End of the day

1. Press Shutdown 2. Press Switch off 3. Press Perform

Wait until screen requests power off. Instrument
performs automatic washing cycle (Intensive 1) &
flush cycle
3

4. Place cleaner to W2 position 5. Press OK

Wait until Clean Cycle is finished
4

5
10

6. Remove cleaner from W2 position 7. Switch Off - Main Switch 8. Unload wash buffer

6 8

9. Empty liquid waste

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Load Cuvettes Credits 11

3  LOAD CUVETTES CREDITS

1. Check cuvette credits 2. Insert Smart Card 3. Press CUVCARD

If number of cuvettes is 0, then insert a new cuvette ring
(see chapter 2). Upload a new cuvette Smart Card only, if
credit and cuvettes are 0. Otherwise credits will get lost

3
2

4. Yes to load balance

4
12

4  LOAD/REPLACE CUVETTES

1. Check if free cuvettes are 0 2. Press Load C Ring 3. Replace cuvette ring (Check triangle position)

1 2

4. Press Done

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Set Reagent Lot 13

5  SET REAGENT LOT

1. Press Setup 2. Press Reagent Setup 3. Select Reagent

2 3

4. Enter Kit Lot No 6. Press Ok

5. Save & Exit

6
CALIBRATION
14

6  LOAD REAGENT

1. Press Load Reagent 2. Place wash buffer to W1 position 3. Select Test

1 3

4. Select Reagent 5. Place Reagent 6. Save and Exit

Add stirrer bar if requested -> Repeat Step 3- 5 for
all other reagents

4
5

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Calibration 15

7  CALIBRATION

1. Press Calibration 2. Select Test 3. Insert values (e.g. ISI/MNPT)

4. Press Calibr. Values 5. Insert Concentration Acc. see analytical value 9. Select cup for calibrator & diluent
sheet of the Hemostat Calibrator 10. Press Start
6. Insert Calibrator Name 11. Follow screen requests
7. Insert Calibrator Lot 12. Place calibrator & diluent
8. Press OK 13. Follow screen requests and wait until calibration is
finished
5
6
4
7

8 9 10 12
16

14. Press Calibr. Values 15. Press Graph 16. Check graph
17. Exit with OK

16

14

15

17

18. Press Ok 19. Press Save & EXit

-> Repeat 1-18 for all test that need
calibration

18 19

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Setup QC 17

8  SETUP QC

1. Enter your Expert Code 2. Select Quality Control 3. Select Westguard Rules

2
3

4. Press Control Setup 5. Select Control 6. Insert QC Lot

7. Save & Exit

4
6
5

7
18

9  ENTER QC LOT DATA (REPEAT THIS FOR EVERY CONTROL)

1. Press Setup 2. Press Test Setup 3. Select test

(Use Expert Level, see 8.1)

2 3

4. Press QC 5. Select Control 6. Select Result Type

7. Select Control Plasma
8. Set Target Value
9. Set 1SD (Target Value - lower limit)/3
5 10. Press OK

10

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Load QC 19

10  LOAD QC

1. Press Load Control 2. Select Control 3. Select vial

Remark: If not available reboot instrument,
after switch on QC 3

1
2

4. Select Test 5. Place Control 6. Press OK

- Repeat Step 2- 5 for all other controls

5
6
20

11  LOAD SAMPLE

1. Press Load Sample 2. Select Sample Position

3. Select Vial
4. Press Sample Name

2
1 3

5. Enter Name or 7. Place Sample 8. Select Test

6. Use Barcode Reader to enter Sample ID - Repeat Step 2- 8 for all other samples
(LIS connection will select test) 9. Press OK to leave

5
6
8
7

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Measure 21

12  MEASURE

1. Press Measurement 2. Press Start Run 3. Press Print

4. Exit with OK

2
3 4
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13  FLAG OVERVIEW

Error Flags Description

State: OK The measurement has been finished with no problems.
State: none No clot detection:
No clot has been found within the set measuring time and valid clotting range.
State: D Deviation Error:
The specified mean value deviation set in the test setup is exceeded.
State: T Temperature Error:
Temperature problems occurred at pipettor or rotor.
State: M Mixer Error:
The mixer motor(s) do not properly work.
State: S Reagent Stirrer Error:
The reagent stirrer motor does not properly work.
State: F Photometer Error:
State: L Liquid Error:
Not enough reagent or sample available during the run.
State: Q QC Error:
A test under Quality Control must be measured within the last 24 hours using the assigned control plasma
before a routine measurement can be done. Additionally this test may not be in violation to the West-
gard-Rules. The Q Error will appear in case these requirements are not fulfilled
State: H Cover (hood) open.
The cover was opened after start the run.

Clot_Convn = <xx The defined limit of the conversion range was reached, the results is claimed as bigger than the maximum
Clot_Convn = >yy range value or smaller than the lowest range value

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Unload Sample 23

14  UNLOAD SAMPLE

1. Load Sample 2. Erase Job List 4. Unload Sample

3. Confirm with Yes

3 4
1

5. Press OK to leave

5
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15  UNLOAD REAGENT

1. Load Reagent 2. Press Remove all Tests 4. Unload Reagent

3. Confirm with Yes (not wash buffer)
5. Unload QC/ Calibrator

1
3
4

5
2

6. Press Save & Exit

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Weekly, Monthly and Yearly Maintenance 25

16  WEEKLY, MONTHLY AND YEARLY MAINTENANCE

1. Use the Guided On-Screen Maintenance Feature

and follow the instructions provided in the User
Manual.
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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