XE-2100 Instructions for Use ver 3.0 July 2003

SYSMEX CORPORATION 1-5-1, Wakinohama-Kaigandori, Chuo-ku Kobe 651-0073, Japan Phone 81-78-265-0521 · Fax 81-78-265-0530 www.sysmex.co.jp SYSMEX EUROPE GmbH Bornbarch 1, 22848 Norderstedt, Germany Phone 49-40-52726-0 · Fax 49-40-52726-100 www.sysmex-europe.com SYSMEX DEUTSCHLAND GMBH Bornbarch 1, 22848 Norderstedt, Germany Phone 49-40-5341020 · Fax 49-40-5232302 www.sysmex.de SYSMEX UK LTD. Sunrise Parkway, Linford Wood (East) Milton Keynes, Buckinghamshire, MK14 6QF, U.K. Phone 44-1908-669555 · Fax 44-1908-669409 www.sysmex.co.uk SYSMEX FRANCE S.A.R.L. Z.I. Paris North II, 22 Avenue des Nations BP: 50414 Villepinte · 95944 Roissy CDG Cédex, France Phone 33-1-48170190 · Fax 33-1-48632350 SYSMEX MOLIS S.A. Rue Prés Champs 25b, 4671 Barchon, Belgium Phone 32-4-3879393 · Fax 32-4-3879394 www.molis.be SYSMEX DANMARK Møsvråvej 23, 6051 Almind, Denmark Phone 45-70204501 · Fax 45-70204541 www.sysmex.dk SYSMEX SVERIGE Kabelgatan 5 43437 Kungsbacka, Sweden Phone 46-300-567202 · Fax 46-300-567203 www.sysmex.se SYSMEX CORPORATION OF AMERICA Gilmer Road, 6699 RFD Long Grove, IL 60047-9596, U.S.A. Phone 1-847-726-3500 · Fax 1-847-726-3505 www.sysmex.com

Distributed by:

•

The contents of the screens illustrated in this manual may differ from the actual screens displayed on the instrument.

•

We reserve the right of continuous product enhancement. This may result in deviation of actual product properties against the properties stated in this manual.

•

The names of patients and doctors used in this manual are fictitious only and are solely used for illustrative purposes.

This instrument carries the CE Mark according the directive 98/79/EC on in vitro diagnostic medical devices.

Copyright © 2001 by SYSMEX CORPORATION All rights reserved. No part of this manual may be reproduced, in any form or by any means, electronic or otherwise, without the prior permission of SYSMEX CORPORATION.

Editorial office: ZINDEL – Technische Dokumentation und Multimedia, www.zindel.de

Table of contents

Table of contents 1.

Introduction ... 1-1

1.1 1.2 1.3

Danger information in this manual... 1-3 Protected names ... 1-3 Abbreviations used throughout this manual ... 1-4

2.

Safety information... 2-1

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13

Specified conditions of use... 2-1 General information ... 2-1 Installation ... 2-2 Electro-magnetic compatibility (EMC) ... 2-2 Avoidance of infections... 2-2 Handling of reagents ... 2-3 Control blood ... 2-3 Laser... 2-3 Maintenance ... 2-4 Disposal of materials ... 2-4 Markings on the instrument ... 2-4 Personnel ... 2-10 Interpretative messages (Flags) ... 2-10

3.

Design and Function... 3-1

3.1 3.2 3.3 3.4 3.5 3.6 3.7

Overview... 3-1 Main Unit ... 3-2 Pneumatic Unit ... 3-9 Sampler ... 3-11 Information Processing Unit (IPU) ... 3-12 Functional description... 3-15 Analysis mode ... 3-17

4.

Reagents ... 4-1

General information ... 4-1 CELLPACK... 4-2 CELLSHEATH ... 4-3 STROMATOLYSER-FB... 4-4 STROMATOLYSER-4DL... 4-5 STROMATOLYSER-4DS ... 4-6 STROMATOLYSER-NR LYSING REAGENT STROMATOLYSER-NR DYE... 4-7 4.8 SULFOLYSER... 4-8 4.9 STROMATOLYSER-IM ... 4-9 4.10 RET-SEARCH(II) DILUENT (RED-300) RET-SEARCH(II) DYE (RED-800) ... 4-10 4.11 CELLCLEAN... 4-11

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4.1 4.2 4.3 4.4 4.5 4.6 4.7

Sysmex XE-2100 - Instructions for use

I

Table of contents

II

5.

Initial Operation ... 5-1

5.1 5.2 5.3 5.4 5.5

Delivery, Storage Until Installation ... 5-1 Preparation ... 5-1 Peripheral devices ... 5-2 Additional components... 5-4 Basic instrument settings ... 5-5

6.

Operation... 6-1

6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 6.14 6.15 6.16 6.17 6.18 6.19 6.20 6.21 6.22

General information about Main Unit operation ... 6-1 Menu tree... 6-3 General information about IPU operation ... 6-4 Signal tones ... 6-9 Checks prior to operation... 6-9 Starting... 6-11 Logging on to the Main Unit ... 6-13 Automatic validation... 6-14 Automatic output ... 6-14 Quality Control ... 6-14 Sample requirements... 6-14 Analysis mode... 6-15 Preparations for sample analysing... 6-16 Analysing in Sampler mode ... 6-19 Analysing samples in Manual mode ... 6-20 Analysing samples in Capillary mode ... 6-21 Analysing samples in Closed mode ... 6-23 Display of analysis results... 6-24 Output of analysis results... 6-24 Interruption of operation... 6-25 End of operation... 6-26 Special functions... 6-30

7.

Display and output of analysis results... 7-1

7.1 7.2

Latest sample... 7-1 Display at the IPU ... 7-3

8.

Sample Storage (Explorer) ... 8-1

8.1 8.2 8.3 8.4 8.5 8.6

Opening the Explorer ... 8-1 LAST20 ... 8-2 Sorting the list ... 8-2 Limiting the list ... 8-3 Searching the list ... 8-5 Backing up data ... 8-6 Sysmex XE-2100 - Instructions for use

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4.12 Symbols used on the label... 4-12

Table of contents 8.7 8.8 8.9 8.10

Restoring data ... 8-6 Deleting an analysis result... 8-7 Sample properties ... 8-7 Tabs... 8-8

9.

Data Browser ... 9-1

9.1 9.2 9.3

Opening the Data Browser ... 9-1 General Information... 9-2 Tabs... 9-4

10. Output... 10-1 11. Quality Control ... 11-1 11.1 11.2 11.3 11.4 11.5 11.6 11.7

Control material ... 11-1 Control methods ... 11-1 Preparations ... 11-2 Performing a quality control... 11-5 Displaying QC data... 11-7 Read-in of a new quality control ... 11-12 Additional information on the QC menu... 11-14

12. Calibration... 12-1 12.1 12.2 12.3 12.4 12.5 12.6

Samples used for calibration ... 12-1 Establishing the reference values... 12-2 Automatic calibration ... 12-2 Manual calibration ... 12-5 Calibration log... 12-7 Printing calibration processes... 12-8

13. Settings ... 13-1 13.1 13.2 13.3 13.4 13.5

Main Unit settings ... 13-1 IPU settings ... 13-3 Factory Settings... 13-12 Adapting the graphical user interface ... 13-17 Changing the display of the Work List, Sample Explorer and Data Browser ... 13-20

14. Cleaning and Maintenance ... 14-1

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14.1 Maintenance schedule... 14-1 14.2 Reading counter counts... 14-2 14.3 Cleaning transducer (TD) chambers and diluted sample lines ... 14-2 14.4 Trap chamber checking and draining ... 14-4 14.5 Cleaning the Sample Rotor Valve (SRV)... 14-5 14.6 Cleaning the rinse cup... 14-8 14.7 Cleaning the SRV tray ... 14-9 Sysmex XE-2100 - Instructions for use

III

Table of contents 14.8 Cleaning the cap-piercer tray... 14-10 14.9 Clog removal... 14-11 14.10 Cleaning the IMI detector aperture ... 14-11 14.11 Cleaning the RBC detector aperture... 14-13 14.12 Removing air bubbles from the flowcell of the optical analyser unit ... 14-15 14.13 Cleaning the flowcell of the optical analyser unit ... 14-16 14.14 Waste tank replacement ... 14-16 14.15 Replacing reagents ... 14-17 14.16 Replacing the piercer ... 14-21 14.17 Replacing the hand clipper or rubber pads ... 14-25 14.18 Replacing fuses ... 14-26 14.19 Adjustment of pressure and vacuum ... 14-27 14.20 List of recommended reagents and supply parts ... 14-32

15. Troubleshooting ... 15-1 15.1 15.2 15.3 15.4

General faults, instrument failure ... 15-3 Error messages... 15-4 Tests ... 15-32 Reading counter counts ... 15-36

16. Technical Information ... 16-1 16.1 16.2 16.3 16.4

Performance characteristics/specifications... 16-1 System limits... 16-6 Interface protocol ... 16-8 Program version... 16-8

17. Warranty ... 17-1 18. Glossary ... 18-1 19. Index ... 19-1 20. Appendix ... 20-1 Flags/interpretative messages ... 20-2 Positive messages ... 20-4 Action messages... 20-4 Error messages... 20-4 Information on tabs ... 20-5

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20.1 20.2 20.3 20.4 20.5

IV

Sysmex XE-2100 - Instructions for use

Introduction

1. Introduction The XE-2100 is an automated haematology analyser for in vitro diagnostic use in clinical laboratories. By using the Sampler a large number of samples can be mixed automatically and supplied to the Main Unit. For single samples (“emergency analysis”) or diluted samples an aspiration pipette is provided. In the Main Unit the samples are analysed. Both whole blood samples and prediluted samples can be measured. For this reason the XE-2100 can also be used with low sample volumes (min. 40 µL). The XE-2100 performs a reliable analysis of a sample within 60 seconds. Up to 32 analysis parameters and 6 research parameters are provided. The analysis results are displayed on the Main Unit's LCD screen. The “Information Processing Unit” (IPU) consists of a PC and software. Here the results produced by the main unit are stored, further parameters calculated and the data managed. Different types of representation (e.g. histograms, scattergrams, etc.) can be referred to. Values that are outside the limits are indicated, so they can be checked and verified by further analysis. Analysis results and diagrams can be printed on any of the connected printers. The accuracy of the results is ensured by an internal quality control. Possible variations are detected quickly and can be eliminated. The XE-2100 is equipped with a rinse cup – after aspiration of a sample or control blood the aspiration pipette is automatically cleaned. It is no longer necessary to wipe the aspiration pipette. Sysmex has been trying hard to keep the noise generation as low as possible. For non-operating periods the compressor can be switched off. By individual settings the user can adapt the instrument to his needs or existing laboratory conditions, respectively. Carefully read the instructions before starting work on the XE-2100. Pay special attention to the safety information. Keep this manual for future reference.

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For further information please contact the Sysmex representative in your country.

Sysmex XE-2100 - Instructions for use

1-1

Introduction Manufacturer SYSMEX CORPORATION 1-5-1 Wakinohama-Kaigandori Chuo-ku, Kobe 651-0073 Japan Authorised Representative in the European Community SYSMEX EUROPE GmbH Bornbarch 1 D – 22848 Norderstedt Tel.: +49 40 5 27 26-0 Fax: +49 40 5 27 26-100 Ordering of Supplies and Replacement Parts If you need to order supplies or replacement parts, please contact your local Sysmex representative. Service and Maintenance Please contact the Service Department of your local Sysmex representative. Training courses

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For further information please contact the Sysmex representative in your country.

1-2

Sysmex XE-2100 - Instructions for use

Introduction

1.1

Danger information in this manual

A

Warning!

High risk. Ignoring this warning could result in personal injury to the operator.

B

Risk of electric shock!

High risk. Ignoring this warning could result in personal injury to the operator.

D A

Dangerous Laser radiation!

High risk. The laser beam may injure your eyes. Caution!

Average risk. Ignoring this warning could cause incorrect measuring results or property damage.

3

Important!

Minor risk. Facts which should be observed when operating this instrument.

✎

Note:

Background information and practical tips.

1.2

Protected names •

Sysmex® is a registered trademark of SYSMEX CORPORATION, Japan.

•

CELLSHEATH, CELLPACK, CELLCLEAN, STROMATOLYSER-FB, -4DL, -4DS, -NR, -IM, SULFOLYSER and RET-SHEATH (II) are trademarks of SYSMEX CORPORATION.

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Windows NT und Windows 2000 are registered trademarks of Microsoft Corporation.

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Cubitainer is a registered trademark of Hedwin Corporation.

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The fact that a trademark is not explicitly mentioned in this manual does not authorize its use.

Sysmex XE-2100 - Instructions for use

1-3

Introduction

1.3

Abbreviations used throughout this manual

General abbreviations abnormal Adaptive Cluster Analysing System Complete Blood Count Direct current Differential blood count decilitre (0.1 litre) Data printer Flow cytometry femtolitre (10-15 litre) Forward scatter light for size/volume of the cell Granulocyte-colony stimulating factor High frequency/Radio frequency Stem cells (human progenitor cells) Current Immature myeloid information lower discriminator lower limit microlitre (10-6 litre) Peripheral stem cell pheresis Peripheral stem cell transplantation pre-diluted mode Sample Rotor Valve Picograms (10-12 gram) Pulse height Quality Control Resistance Standard deviation Cell (side) fluorescence intensity System International (for parameter units) Sodium Lauryl Sulfate Stem cell monitoring program Standard Side scatterlight = internal cell structure Voltage upper discriminator upper limit Volume

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ABN ACAS CBC DC D, Diff dL DP FCM fL FSC G-CSF HF, RF HPC I IMI LD LL µL PBSCH PBSCT PD SRV pg PH QC R SD SFL SI SLS SCMP SRD SSC U UD UL V

1-4

Sysmex XE-2100 - Instructions for use

Introduction Abbreviations XE-2100 Data Browser Explorer GP HC H-Copy HF/RF HPC IMI IPU Last 20 LP QC Q-Flag

Graphical representation of samples Stored data Sending of data to graphics printer Sending of data to host computer Hardcopy, printout of the current screen page High frequency/Radio frequency Human Progenitor Cells Immature myeloid information (channel for immature cells) Information Processing Unit Display of the last 20 samples Sending of data to line printer (text print) Quality control program Quantified flag representation

Analysis Parameters The XE-2100 provides results for the following parameters: WBC RBC HGB HCT

PLT

Number of all leucocytes Number of all erythrocytes Haemoglobin concentration Haematocrit value: Erythrocytes ratio of total blood volume Mean erythrocyte volume in total sample Mean haemoglobin volume per RBC Mean haemoglobin concentration of erythrocytes Total number of platelets

NEUT% LYMPH% MONO% EO% BASO% NRBC% NEUT# LYMPH# MONO# EO# BASO# NRBC#

Neutrophils quota in percent Lymphocytes quota in percent Monocytes quota in percent Eosinophils quota in percent Basophils quota in percent Quota of nucleated erythrocytes in percent Neutrophils count, absolute Lymphocytes count, absolute Monocytes count, absolute Eosinophils count, absolute Basophils count, absolute nucleated erythrocytes count, absolute

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MCV MCH MCHC

Sysmex XE-2100 - Instructions for use

1-5

Introduction RDW-SD RDW-CV

Calculated distribution width of erythrocytes, standard deviation Calculated distribution width of erythrocytes, coefficient of variation

PDW MPV P-LCR

Calculated distribution width of platelets Mean platelet volume Ratio of large platelets (volume exceeding 12 fL) to the total number of platelets

PCT

Platelets quota of the total volume

RET% RET# IRF

Reticulocytes quota in percent Reticulocytes count, absolute Fraction of immature reticulocytes

LFR MFR

Reticulocytes with low fluorescence quota Reticulocytes with medium fluorescence quota Reticulocytes with high fluorescence quota

HFR

Research parameters The following additional parameters are detemined for research purposes only: IG% IG# HPC% HPC# Other% Other#

Quota of immature granulocytes in percent Quota of immature granulocytes, absolute Quota of Human Progenitor cells in percent Quota of Human Progenitor cells, absolute Quota of highly fluorescent cells such as atypical lymphocytes in percent Quota of highly fluorescent cells such as atypical lymphocytes, absolute

Flag information Immature cells

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IMI

1-6

Sysmex XE-2100 - Instructions for use

Safety information

2. Safety information 2.1

Specified conditions of use The XE-2100 shall only be used for in vitro analysis of human blood or artificial control blood. Any other use is regarded as non-specified. Only the reagents and cleaning solutions mentioned in this manual may be used. The specified conditions of use also entail the observance of the laid-down cleaning and maintenance rates.

General information •

Read the instructions before operating the instrument. Observe all cautionary markings in the manual and on the instrument. Keep this manual for future reference.

•

This instrument must only be opened as instructed in this manual.

•

Keep long hair, fingers and clothing away from rotating parts.

•

Should the instrument emit unusual odours or smoke, turn the main switch OFF immediately and unplug the power cable. Using the instrument any further bears the risk of fire, electric shock or personal injury. Contact the Sysmex service representative.

•

Do not spill blood samples or reagents onto the instrument. Also take care not to allow any objects to fall into the instrument. This could cause a short-circuit. If this happens, turn the main switch OFF immediately and unplug the power cable. Contact the Sysmex service representative.

•

Do not touch the electric circuits inside the instrument. Especially with wet hands, as there is a risk of electric shock.

•

This instrument must be connected to a power outlet of correct voltage. Please note that the instrument must be earthed.

•

Avoid damage to the power cable. Do not place any appliances on the power cable. Do not pull on the power cable.

•

Switch the power supply to the instrument OFF before connecting any additional devices (host computer, printer etc.).

•

Use the check-digit as much as possible. If the check-digit cannot be used, the potential of the incorrect reading of the barcode label may be increased.

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2.2

Sysmex XE-2100 - Instructions for use

2-1

Safety information

2.3

2.4

Installation •

The instrument must be installed in a dry and dust-free location.

•

It must be protected against splash water.

•

Do not expose the instrument to excessive temperature fluctuation and direct sunlight.

•

Avoid shocks and vibrations.

•

The place of installation must be well ventilated.

•

Avoid installation near devices causing interference, such as radios, centrifugal machine, or similar.

•

Installation of this instrument in places where chemicals are stored or gas develops is not permitted.

Electro-magnetic compatibility (EMC) This instrument complies with the following IEC (EN) standards: IEC 61326-1:97 + A1:98 (EN61326:97+A1) Electrical equipment for measurement, control and laboratory use - EMC requirements

•

EME (electromagnetic emission (= interference radiation)) Class A requirements are met.

•

EMI (electromagnetic immunity (= resistance to jamming)) The minimum test requirements concerning immunity are met.

Avoidance of infections •

In principle, all parts and surfaces of the XE-2100 must be regarded as potentially infective.

•

Always wear rubber gloves when carrying out work on or with the XE-2100. After completion of work, wash hands with disinfectant.

•

Never touch waste, or parts having been in contact with waste, with bare hands.

•

Should you inadvertently have come in contact with potentially infective materials or surfaces, immediately rinse skin thoroughly with water, then follow the antiseptic regulations of your laboratory.

•

Even control blood must be regarded as potentially infective. Wear rubber gloves when performing quality controls.

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2.5

•

2-2

Sysmex XE-2100 - Instructions for use

Safety information

2.6

2.7

•

Observe the labelling of the reagent packages as well as the information given on the package insert.

•

Avoid direct contact with reagents. Reagents can cause irritation of the eyes, skin and mucous membranes.

•

Should you inadvertently have come in contact with reagent, rinse skin immediately with plenty of water.

•

At eye contact, rinse at once with plenty of water. See a doctor without delay. Observe the material data safety sheet.

•

If reagent has inadvertently been swallowed consult a physician immediately!

•

Avoid contact of dust, dirt or bacteria with the reagent.

•

Reagents must not be used after their expiration date.

•

Handle reagents gently to avoid bubbling. Do not shake! Do not use directly after transportation.

•

Reagents must not be spilled. If it happens nevertheless, wipe up with a damp cloth.

•

The CELLPACK diluent is a good conductor. If diluent was spilled inadvertently near electrical cables or appliances, there is a risk of electric shock. Switch the instrument off, unplug and remove the liquid.

•

CELLCLEAN is a strong alkaline cleaning material. It should not come in contact with skin or clothing. If it happens nevertheless, rinse skin or clothing with plenty of water to avoid injury or damage, respectively.

•

The CELLCLEAN cleaning material contains sodium hypochlorite. If CELLCLEAN makes contact with the instrument's surfaces, it will affect the surface finish. Danger of corrosion. Immediately wipe up CELLCLEAN with a damp cloth.

•

RET-SEARCH (II) and STROMATOLYSER-4DS are detrimental to health. Keep the containers tightly closed.

•

Do not inject or ingest.

•

Control blood must always be stored in an upright position – irrespective of whether the vial has been opened or is still closed.

•

In order to carry out specific measuring methods the XE-2100 is equipped with a class 2a semiconductor laser. The metal box screening off the laser must never be

Control blood

Laser

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2.8

Handling of reagents

Sysmex XE-2100 - Instructions for use

2-3

Safety information removed. The emitted laser radiation can cause damage to the eyes.

2.9

Maintenance •

To avoid the risk of infections, electric shock or burns, wear rubber gloves for all service or maintenance work. After completion of work, wash hands with disinfectant.

•

When carrying out maintenance work, use only the tools expressly provided for such work.

•

Install only such spare or replacement parts expressly intended for the XE-2100.

•

Disposal procedures for residual reagents, detergent and all waste must meet the requirements of all applicable local regulations.

2.10 Disposal of materials

2.11 Markings on the instrument Front side, front door open

1

6 3 4 5

1

A

A A A

Warning!

When working with the front cover open, make sure that the stop bar is in place.

2-4

Sysmex XE-2100 - Instructions for use

07.2003 – 3.0_en

A

2

7

A A

Safety information 2

A

Warning!

Switch up during service adjustment. Switch down during normal operation. The label is behind the cover of the IMI detector block.

3

B

Warning!

Do not touch the transducer when the power in ON to avoid electric shock. 4

A

Warning!

A

Warning!

Never open the cap piercer cover if the instrument is turned on. 5

Do not put your finger inside to avoid being injured. The lable is on the inside. 6

3

Note:

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When replacing the FFS reagent bag, make sure that the two FFS labels face to the same direction to avoid sensor malfunction.

Sysmex XE-2100 - Instructions for use

2-5

Safety information 7

B

Warning!

Do not touch the transducer when the power in ON to avoid electric shock. Rear side

A

1 2

1

A

Warning!

To avoid electrical shock, disconnect supply before servicing. For the continued protection against risk of fire, replace only with fuse of the specified type and current ratings. 2

Type plate

SN

Serial number Date of manufacture Manufacturer In Vitro Diagnostic Medical Device

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IVD

2-6

Sysmex XE-2100 - Instructions for use

Safety information Sampler

1

1

A

A

Caution!

The sample tubes must move easily in the rack. If not, replace the label. The sample tubes must be capped tightly.

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The sample tubes must be inserted fully to the bottom of the rack, otherwise the blood volume sensor will not recognize the blood sample.

Sysmex XE-2100 - Instructions for use

2-7